Reducing the incidence of infections associated with transdermal insertion sites

Abstract

Disclosed are patch devices, methods, kits and systems for reducing the incidence of infections associated with the insertion site of a transdermal medical device (e.g., blood stream infections, infections of the skin opening through which the device enters the body, CLABSI, CRBSI) for example, the insertion site where a cannula or catheter enters a living body by generating an electromagnetic antiseptic signal in proximity of the insertion site.

Description

[0001] REDUCING THE INCIDENCE OF INFECTIONS ASSOCIATED WITH TRANSDERMAL INSERTION SITES

[0002] RELATED APPLICATION

[0003] The present application gains priority from US Provisional Patent Application 63 / 686,724 filed 23 August 2024 which is included by reference as if fully set-forth herein.

[0004] FIELD AND BACKGROUND OF THE INVENTION

[0005] The invention, in some embodiments relates to the field of infection control and more particularly but not exclusively to patch devices, methods, kits and systems for reducing the incidence of infections associated with the insertion site of a transdermal device (e.g., blood stream infections, infections of the skin opening through which the device enters the body, CLABSI, CRB SI) for example, the insertion site where a cannula or catheter enters a living body by generating an electromagnetic antiseptic signal in proximity of the insertion site.

[0006] Bloodstream infection is a severe medical condition characterized by the presence of pathogens, such as bacteria, viruses, or fungi, in the bloodstream. When pathogens enter the bloodstream, they can trigger a systemic inflammatory response, potentially leading to organ dysfunction and failure. Early detection and prompt treatment are critical, as bloodstream infections can escalate rapidly, posing a life-threatening risk. Common symptoms include fever, rapid heart rate, and altered mental status. Diagnosis often involves blood cultures to identify the causative agent, and treatment typically requires the administration of appropriate antibiotics or antifungal medications.

[0007] Biofilms play a significant role in bloodstream infections and catheter-related bloodstream infections (CRBSIs). Biofilms can form on medical devices such as catheters, which are commonly used for intravenous therapy, dialysis, and other medical procedures. A biofilm is a structured community of microorganisms enclosed in a self-produced extracellular matrix, which adheres to a surface. Once adhered, these microorganisms start forming a biofilm, creating a protective environment that shields them from the immune system and antimicrobial treatments. In cannula-related bloodstream infections (CLABSIs), biofilms on catheter surfaces are a major contributor. Microorganisms within biofilms on catheters can enter the bloodstream, leading to systemic infections. The risk of sepsis and other complications increases when biofilm-associated microorganisms detach from the catheter and disseminate throughout the bloodstream. In the intensive care unit (ICU) environment, central-line associated bloodstream infections pose a significant challenge due to the vulnerable condition of critically ill patients and the increased risk of exposure to invasive medical procedures. ICU patients often have compromised immune systems, and multiple transdermal medical devices creating potential entry points for pathogens.

[0008] Prevention strategies in the ICU involve stringent infection control measures, including hand hygiene, aseptic insertion and maintenance of catheters, and proper disinfection of medical equipment. Continuous monitoring of patients for signs of infection, routine surveillance cultures, and early initiation of appropriate antimicrobial therapy are crucial in managing bloodstream infections in the ICU, aiming to reduce morbidity and mortality among critically ill individuals.

[0009] Preventing central-line associated bloodstream infections (CLABSI) and catheter- related blood stream infections (CRBSI) is of importance in healthcare settings, particularly in the ICU where patients often require intravenous access for various treatments.

[0010] Common clinical practice to minimize the risk of these infections are based on aseptic techniques, including proper hand hygiene, sterile gloves, and the disinfection of the insertion site. Chlorhexidine Gluconate (CHG, also called chlorhexidine) is an antiseptic solution regularly used to clean the skin before catheter or cannula insertion reducing the microbial load on the skin. CHG is a broad-spectrum biocide effective against Gram-positive bacteria, Gram-negative bacteria, and fungi.

[0011] I n common practice sterile IV dressings that include CHG are used in healthcare settings for blood stream infection prevention. These dressings are designed to provide a sterile environment while also delivering the antimicrobial properties of CHG.

[0012] Alternatively silver dressings are used to prevent blood stream infections. In these products release silver ions, which are known to have broad-spectrum antimicrobial properties, meaning it can act against a wide range of microorganisms, including bacteria, viruses, and fungi.

[0013] A known approach to prevent CLBSI is the use of Antimicrobial-Impregnated Catheters. These catheter tubes are coated or impregnated with antimicrobial agents, such as silver or minocycline / rifampin. These coatings assist to inhibit bacterial colonization on the catheter surface, hence reducing the risk of bloodstream infections. An example for such a product is Ares™ Antibiotic-Impregnated Catheters from Medtronic (Dublin, Ireland).

[0014] Electric stimulation driven at low currents is known in the art as being capable of preventing multiple bacterial cultures from growing (see "Effect of electrical energy on the efficacy of biofilm treatment" by Kim YW, Subramanian S, Gerasopoulos K, Ben-Yoav H, Wu HC, Quan D, Carter K, Meyer MT, Bentley WE, Ghodssi R in Biofilms and Microbiomes 2015, 1, 15016; "Bioelectric effect and bacterial biofilms. A systematic review" by Del Pozo JL, Rouse MS, Patel DR in Int J Artif Organs. 2008 September; 31(9): 786-795; "Electroceutical Management of Bacterial Biofilms and Surgical Infection" by Sen CK, Mathew-Steiner SS, Das A, Sundaresan VB and Roy S in Antioxis Redox Signal2020, 22(10) 713-724) Although the mechanism is not fully understood, without being bound to any specific mechanism, it is assumed that electric signals can interfere with the attachment of microbial cells to the surface of the device that is introduced into a blood vessel. This is particularly crucial in the early stages of biofilm formation, where microorganisms adhere to the surface before forming the protective extracellular matrix.

[0015] SUMMARY OF THE INVENTION

[0016] Some embodiments of the invention herein relate to patch devices, methods, kits and systems for reducing the incidence of infections associated with the insertion site of a transdermal device (e.g., blood stream infections, infections of the skin opening through which the device enters the body, CLABSI, CRB SI) for example, the insertion site where a cannula or catheter enters a living body by generating an electromagnetic antiseptic signal in proximity of the insertion site.

[0017] According to an aspect of some embodiments of the teachings herein, there is provided a patch device for reducing the incidence of infections associated with the insertion site of a transdermal medical device comprising: a patch body having a perimeter, the patch body comprising a multilayer sheet, the multilayer sheet having at least two layers; an electrically-conductive biocompatible layer having a perimeter, a thickness, an upper surface and a lower contact surface; and a dielectric electrode-bearing layer having a perimeter, a thickness, an upper surface and a lower surface, wherein to the lower surface of the electrodebearing layer are attached at least two electrodes of a conductive material, wherein the lower surface of the electrode-bearing layer intimately contacts the upper surface of the biocompatible layer so that the electrodes are disposed between the biocompatible layer and the electrode-bearing layer, the patch device further comprising an electrical connector in electrical communication with the electrodes. In some embodiments, the device is configured to receive an antiseptic current from a driving unit through the electrical connector, the antiseptic current characterized by: having a pulsed DC waveform with a frequency of not more frequent than about 0.1 Hz and not less frequent than about 10 Hz; having a potential of not less than about 0.1 V and not greater than about 10 V; and having an intensity of not less than about 1 microampere and not more than about 2 milliampere.

[0018] In some embodiments, patch body is conformable

[0019] In some embodiments, the patch body includes a slit extending from a perimeter of the patch body to a slit-terminus located at an inner portion of the patch body, the slit having two edges, the slit allowing passing the shaft of a transdermal medical device from the perimeter of the patch body to the slit terminus while the transdermal medical device is deployed in the body of a living animal.

[0020] In some embodiments, the slit terminus is a through-hole through the biocompatible layer and the electrode-bearing layer that has dimensions to encircle the shaft of a transdermal medical device having a specific size.

[0021] In some embodiments, the patch body includes a through-hole passing from the upper surface of the patch body, through the electrode-bearing layer and through the biocompatible layer, the through-hole configured to accommodate the shaft of a transdermal medical device having a specific size, wherein the through-hole is not associated with a slit in the patch body.

[0022] In some embodiments, the patch body is a sheet without a through-hole configured to accommodate the shaft of a transdermal medical device and without a slit allowing passing the shaft of a transdermal medical device from the perimeter of the patch body to a slit terminus. In some such embodiments, the patch body is configured to allow: cutting the patch body to make a slit allowing passing the shaft of a transdermal medical device from the perimeter of the patch body to a slit terminus while the transdermal medical device is deployed in the body of a living animal; and / or perforating the patch body to make a through-hole passing from the upper surface of the patch body, through the electrode-bearing layer and through the biocompatible layer, the through-hole configured to accommodate the shaft of a transdermal medical device.

[0023] In some embodiments, the thickness of the biocompatible layer is not less than about 10 micrometers and not more than about 3 mm. In some embodiments, the electrode-bearing layer is an outer cover layer of the patch body. Alternatively, in some embodiments, the patch body further comprising an additional outer cover layer different from the electrode-bearing layer, the outer cover layer having a perimeter, a thickness, an upper surface and a lower surface, the lower surface of the outer cover layer facing the upper surface of the electrode-bearing layer.

[0024] In some embodiments, the perimeter of the outer cover layer is larger than the perimeter of the biocompatible-layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the outer cover layer extend outwards beyond the perimeter of the biocompatible layer and overhang the biocompatible layer so that the lower surface of the overhanging portions of the outer cover layer contact the skin during use of the patch device.

[0025] In some embodiments, the device further comprises a dislodgement sensor to identify if the patch body has been dislodged after being placed on a skin surface in proximity of a skin opening through which a shaft of a transdermal medical device passes. In some such embodiments, the perimeter of the outer cover layer is larger than the perimeter of the biocompatible-layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the outer cover layer extend outwards beyond the perimeter of the biocompatible layer and overhang the biocompatible layer so that a lower surface of the overhanging portions of the outer cover layer contact the skin during use of the patch device, wherein the lower surface of the overhanging portions bear electrodes of the dislodgement sensor.

[0026] In some embodiments, the device further comprises a conductive element, the conductive element configured to be attached to the shaft of a transdermal medical device and also configured to receive an antiseptic current from an electrical power source.

[0027] According to an aspect of some embodiments of the teachings herein, there is provided a method for reducing the incidence of infections associated with the insertion site of a transdermal device, the method comprising: i. deploying a transdermal medical device in the body of a living animal so that a shaft of the transdermal medical device penetrates into a skin opening through a transdermal passage so that a distal end of the shaft is located inside the body and a proximal end of the shaft is located outside of the body; ii. placing a patch body of a patch device according to the teachings herein with a perimeter of the patch body in proximity of the location of the skin opening and so that a lower contact surface of a biocompatible layer of the patch body makes intimate contact with a skin surface of the living animal; iii. subsequently to both 'i' and 'ii', activating a driving unit that is functionally- associated with electrodes of the patch body through an electrical connector of the patch device to provide an antiseptic electrical current to the electrodes, thereby producing an antiseptic signal in the biocompatible layer that has an antiseptic effect at the interface between the skin surface and a contact surface of the biocompatible layer, the antiseptic signal thereby decreasing development of a biofilm and / or pathogens on the skin surface and in proximity of the perimeter of the patch body.

[0028] In some embodiments, the animal is a non-human animal. In some embodiments, the animal is a human.

[0029] In some embodiments, the deploying the transdermal medical device 'i' is done prior to the placing the patch body 'ii'.

[0030] In some embodiments, the deploying the transdermal medical device 'i' is done subsequent to the placing the patch body 'ii'.

[0031] In some embodiments, the deploying the transdermal medical device 'i' and the placing the patch body 'ii' are done concurrently.

[0032] In some embodiments, the perimeter that is placed in proximity of the location of the skin opening is an outer perimeter of the patch body.

[0033] In some embodiments, the perimeter that is placed in proximity of the location of the skin opening is a perimeter of a through-hole or of a slit-terminus of the patch body.

[0034] In some embodiments, no part of the shaft is in contact with the patch body. Alternatively, in some embodiments, at least part of the shaft is in contact with the patch body.

[0035] In some embodiments, the patch body contactingly-encircles the shaft.

[0036] In some embodiments, the method further comprises placing a dislodgement sensor associated with the patch device to monitor that the patch body does not move.

[0037] In some embodiments, a portion of an outer surface of the shaft that is located outside of the body of the animal is electrically-conductive and the method further comprises: placing the electrically-conductive portion of the outer surface of the shaft in an electrical circuit configured to carry an antiseptic electrical current;and providing an antiseptic electrical current to the electrically-conductive portion through the circuit to produce an antiseptic signal at the electrically-conductive portion of the outer surface of the shaft. According to an aspect of some embodiments of the teachings herein there is also provided a system for preventing infections associated with the insertion site of a transdermal device (e.g., blood stream infections, infections of the skin opening through which the device enters the body). In some embodiments, the system comprises three separate components: a patch device as described herein; a driving unit as described herein; and a power source for providing power to the driving unit, wherein operation of the system includes functionally- associating the power source with the driving unit and functionally-associating the driving unit with the patch device.

[0038] Alternatively, in some embodiments, the system comprises two separate components: a patch device as described herein comprising a driving unit as component thereof; and a power source for providing power to the driving unit, wherein operation of the system includes functionally-associating the power source with the driving unit.

[0039] Alternatively, in some embodiments, the system comprises two separate components: a patch device as described herein; and a driving unit as described herein with a power source for providing power to the driving unit as a component thereof, wherein operation of the system includes functionally-associating the driving unit with the patch device.

[0040] Alternatively, in some embodiments, the system comprises: a patch device as described herein comprising a driving unit as component thereof, the driving unit comprising a power source for providing power to the driving unit.

[0041] In the instant application and in the priority document, the terms "patch", "conductive patch" and "conductive patch device" are synonyms for the term "patch device". Similarly, the terms “catheter”, “cannula”, “vascular access line”, “access line device”, “central line device”, “central line catheter” and “tube” may be used interchangeably throughout the description unless the context dictates otherwise. For example, whereas a catheter is always a tube, not all tubes are catheters. These terms are all species of the more general genus "transdermal medical device".

[0042] BRIEF DESCRIPTION OF THE FIGURES

[0043] Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the invention may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

[0044] In the Figures:

[0045] Figures 1A and IB schematically depict an embodiment of a patch device according to the teachings herein in view from the top (Figure 1A) and in side-cross section (Figure IB);

[0046] Figure 2 depicts an embodiment of a patch device according to the teachings herein in schematic side-cross section;

[0047] Figure 3 depicts an embodiment of a patch device according to the teachings herein in schematic side-cross section;

[0048] Figure 4 schematically depicts an embodiment of a patch device having a square patch body, a slit and a through-hole according to the teachings herein in top view;

[0049] Figure 5 schematically depicts an embodiment of a patch device having a circular patch body, a slit and a through hole according to the teachings herein in top view;

[0050] Figure 6A schematically depicts an embodiment of a patch device having a cruciform patch body, a slit and a through-hole according to the teachings herein in top view;

[0051] Figure 6B schematically depicts the use of a patch device of Figure 6A together with a cannula, where the cannula is deployed in a body, entering the body through a skin opening;

[0052] Figure 7 is a flowchart describing a method of using a patch device according to the teachings herein;

[0053] Figures 8A - 8H schematically depict different embodiments of the patch body of a patch device according to the teachings herein together with a cannula viewed from above; and

[0054] Figure 9 schematically depicts a conductive element encircling a shaft of a transdermal medical device used in conjunction with a patch device according to the teachings herein.

[0055] DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

[0056] Some embodiments of the invention herein relate to patch devices, methods, kits and systems for reducing the incidence of infections associated with the insertion site of a transdermal device (e.g., blood stream infections, infections of the skin opening through which the device enters the body) for example, the insertion site where a cannula or catheter enters a living body by generating an electromagnetic antiseptic signal in proximity of the insertion site. For the purpose of explanation, specific exemplary configurations and details are set forth in order to provide a thorough understanding of the device.

[0057] As used herein, a transdermal medical device (in some embodiments, also called an access line device) is a device having a shaft, so when the device is deployed in a living animal the shaft passes from outside of the body of the living animal through an opening in the skin, past the skin to inside the body through a transdermal passage. Exemplary such devices include intravenous cannulae and central venous catheters.

[0058] In intravenous cannula and central venous catheters the shaft comprises a singlelumen or multi-lumen tube. When such devices are deployed, the tube passes through an opening in the skin, past the skin and into a vein so that the open distal end of the tube is located inside the lumen of the vein. Once deployed, cannula and catheters may be used for intravenous administration of fluids, medications and nutrition or for withdrawing venous blood samples via the open distal end.

[0059] As known in the art, some transdermal medical devices, especially cannulae, are often left deployed in a body for a substantial period of time of multiple days and even weeks. During this time, pathogens (including bacteria and fungi) can develop on the skin near the skin opening and on the part of the shaft that is located outside of the body. Such pathogens can pass into the body via the skin opening causing an infection and even bloodstream infection. As discussed above in the introduction, particularly problematic is when pathogens form a biofilm on the skin near the skin opening or on medical equipment near the skin opening, especially on the shaft of the transdermal medical device.

[0060] In the art it is known to cover the area surrounding the skin opening of a transdermal medical device with a split dermal pad. Some such pads have a contact layer and a protective layer, a center hole dimensioned to fit around a transdermal medical device shaft of a specific size, and a slit that splits the two layers to connect the center hole with the periphery of the pad. The contact layer is a sheet of a non skin-irritating material, such as a hydrogel (e.g., alginate) impregnated with an antiseptic composition such as chlorhexidine. The contact layer is typically at least 3 mm thick. It is preferred that the contact layer be as thick as possible for at least two reasons: the thicker the layer the greater the exudate-absorbing capacity and the thicker the layer the greater the amount of antiseptic composition in the layer which provides a longer-lasting antiseptic effect. The protective layer is a thin tear-resistant polymer such as known in the art of adhesive bandages, typically around 0.1 - 0.2 mm thick. The pad is provided individually-packed in a sterile peel-open pouch and with a backing covering the contact layer. For use, the pad is removed from the pouch and the backing is removed, as is known in the art of adhesive bandages. While a transdermal medical device is deployed in a subject, a portion of the shaft that is located outside of the body is placed in the center hole of the pad through the slit where the contact layer faces the skin surface. The contact layer is then pressed against the skin. The pad is secured to the skin, for example with adhesive that is located at the edges of the protective layer surrounding the contact layer or with adhesive tape that is not part of the pad. The pad and a relatively large area of skin around the paid is then covered with a transparent film dressing (e.g., Tegaderm by 3M, St Paul, Minnesota, USA). As long as the device is deployed and the pad is in place, exudate from the skin opening is absorbed by the contact layer. Further, the antiseptic composition in the contact layer diffuses to the skin / contact layer interface.

[0061] Such pads are known to be ineffective in preventing pathogen development outside the bounds of the contact layer, i.e., at the periphery of the pad but more importantly on the skin surfaces and shaft surfaces located inside the center hole of the pad as at least some of these surfaces have insufficient contact with the contact layer to allow for a robust antiseptic effect. Further, the amount of antiseptic material held by the contact layer is limited so that the concentration of antiseptic is reduced over time until it is no longer effective.

[0062] In some embodiments, the teachings herein provide patch devices, kits, systems and methods of using such patch devices that are used together with a transdermal medical device, especially a cannula or catheter, especially an intravenous cannula or central venous catheter. The patch device is configured to generate an antiseptic electromagnetic signal having an antiseptic effect and to apply the signal to the skin surface and / or shaft of the transdermal medical device. The antiseptic signal is an electromagnetic signal that inhibits the development of pathogens such as bacteria, fungi and viruses on living tissue such as skin and mucous membranes by killing and / or inhibiting the growth of the pathogens and by inhibiting the development of a biofilm, including on surfaces that are not in direct contact with the patch device. As a result of the application of the antiseptic signal, the incidence of pathogen development and concomitant negative health effects is reduced.

[0063] According to an aspect of some embodiments of the teachings herein, there is provided a patch device for reducing the incidence of infections associated with the insertion site of a transdermal medical device comprising: a patch body having a perimeter, the patch body comprising a multilayer sheet, the multilayer sheet having at least two layers; an electrically-conductive biocompatible layer having a perimeter, a thickness, an upper surface and a lower contact surface; and a dielectric electrode-bearing layer having a perimeter, a thickness, an upper surface and a lower surface, wherein to the lower surface of the electrodebearing layer are attached at least two electrodes of a conductive material, wherein the lower surface of the electrode-bearing layer intimately contacts the upper surface of the biocompatible layer so that the electrodes are disposed between the biocompatible layer and the electrode-bearing layer, the patch device further comprising an electrical connector in electrical communication with the electrodes.

[0064] Adhesive layer

[0065] In some embodiments, the patch body is devoid of an adhesive layer between the upper surface of the biocompatible layer and the lower surface of the electrode-bearing layer and the two layers are held together in intimate contact by the inherent mutual adhesion, e.g., due to electrostatic attraction.

[0066] Alternatively, in some embodiments, the patch body comprises an adhesive layer between the upper surface of the biocompatible layer and the lower surface of the electrodebearing layer so that the lower surface of the electrode-bearing layer intimately contacts the upper surface of the biocompatible layer through the adhesive layer. The adhesive layer is made of any suitable adhesive as known in the art of wound dressings and is typically between about 10 micrometers and about 100 micrometers thick, The nature of the adhesive and the thickness of the adhesive layer is such that does not interfere with the electrical interaction of the electrodes with the biocompatible layer.

[0067] Action of the patch device

[0068] The patch device is configured so that when the contact surface of the biocompatible layer is in intimate contact with skin and an antiseptic current passes through the electrical connector to the electrodes, an antiseptic signal is produced in the biocompatible layer between neighboring electrodes of opposite polarities. The antiseptic signal in the biocompatible layer has an antiseptic effect at the interface between the skin and the contact surface of the biocompatible layer. It was originally expected that the antiseptic effect would be found only in portions of the contact surface that are positioned directly below a given electrode or portions of the contact surface that are directly below the space between any two neighboring electrodes of opposite polarity. Surprisingly, the antiseptic effect of the signal is found on parts of the skin / contact surface interface that are distant from an electrode or the space between two electrodes. Further, it is observed that the antiseptic effect extends from the electrodes nearest the shaft of the transdermal medical device towards the shaft, even to portions of skin, the entry hole and portions of the shaft that are not in physical contact with biocompatible layer. Although the exact distance is dependent on the exact nature of the biocompatible layer, the arrangement of the electrons and of the antiseptic current, typically there is a substantial antiseptic effect at least about 1 mm and even at least about 2 mm from the perimeter of the biocompatible layer. This is particularly important as the antiseptic effect is present where in locations which are not necessarily easy to contact with the contact surface of the biocompatible layer, for example, the skin opening and the shaft of the transdermal medical device.

[0069] Additionally, unlike known pads that include a limited amount of antiseptic composition that diffuses from the bulk of a contact layer to a skin surface, the antiseptic signal of a patch device according to the teachings herein provides an unchanging antiseptic effect as long as the antiseptic current is provided to the electrodes.

[0070] Driving Unit

[0071] For operation of the patch device, the electrodes are connected to a driving unit through the electrical connector of the patch device.

[0072] The driving unit comprises a waveform generator to provide an antiseptic current to the electrodes having the desired strength (ampere), potential and waveform to generate an antiseptic signal.

[0073] A driving unit typically comprises a PCB configured to receive electricity from an electric power supply and to output the antiseptic current. The driving unit typically also includes an activation ("on") switch although in some alternative embodiments there is no such switch and the device is activate when the driving unit and / or power supply is connected to the electrical connector.

[0074] In some embodiments, the driving unit includes other components such as a computer processor, a wireless communication components (e.g., allowing radiofrequency communication, e.g. Bluetooth® or IR communication) and / or a graphic display components (e.g., LCD, LED) optionally configured as a GUI and / or status indicators such as one or more LEDs (e.g., blue LED activated when the patch is functioning, red LED to indicate a fault) and / or an electrical transformer.

[0075] In some embodiments, a driving unit comprises a power supply such as a battery. Alternatively, in some embodiments, a driving unit does not comprise a power supply and a power supply that is not a component of the driving unit is separately provided by a user in order to use the patch device.

[0076] In some embodiments, the driving unit is a component of the patch device and is irreversibly connected to the electrical connector. As used herein, "irreversible connection" does not preclude damaging one or more components in order to separate the driving unit from the electrical connector.

[0077] In some alternative embodiments, the driving unit is a component of the patch device and the electrical connector is configured for reversible electrical attachment to a driving unit that is a component of the patch device. In some such embodiments, the patch device and the driving unit are provided together as a kit.

[0078] In some alternative embodiments, the driving unit is not a component of the patch device and the electrical connector is configured for reversible electrical attachment to a driving unit that is not a component of the patch device.

[0079] In some embodiments, the driving unit is configured to output a single antiseptic current having a constant set of parameters. In some embodiments, the driving unit comprises a controller, the controller configured to receive user instructions and, based on the received instructions, at any one moment output one of at least two different antiseptic currents. The controller is configured in any suitable way to receive user instructions for example, to receive instructions wirelessly (e.g., via Bluetooth® from a suitably configured device such as a smartphone) or wired (e.g., via a USB connection). In some embodiments, the controller and the driving unit are two separate unrelated components. In some such embodiments, when it is desired for the controller to control the driving unit (e.g., to configure the driving unit and / or to send commands to the driving unit), a communication channel is established between the controller and the driving unit (e.g., a wired or a wireless communication channel) through which the controller controls the driving unit.

[0080] Antiseptic current

[0081] The antiseptic current that is provided by the driving unit is any suitable antiseptic current. Antiseptic currents that are provided to electrodes to produce an antiseptic signal are known in the art, see for example: "Antibacterial Efficacy Testing of a Bioelectric Wound Dressing Against Clinical Wound Pathogens" by Kim H, Makin I, Skiba J, Ho A, Housler G, Stojadinovic A, Izadjoo M in Open Microbiol J. 2014, 8, 15-21. "The Antimicrobial Effect of a Low-Frequency Square Wave Compared to Chlorhexidine" by Choi JW, Byeon SM, Lee DH, Yun PY amd Ku JK in J Clin Med 2025, 14(7), 2429; "Bacterial Inhibition by Electrical Stimulation" by Asadi MR and Torkaman G in Adv Wound Care 2014, 3(2), 91-97; and "Revealing detrimental effects of various DC electrical energy conditions on different multidrug resistant bacteria: a comprehensive study" by Shawki MM, El-Shall HS, Moustafa ME, Atay KYS, Elsherdy AG, Eltarahony MM in Scientific Reports 2024, 14, 17046.

[0082] A given patch device according to the teachings herein is configured, inter alia, the construction of the electrical connector, of the leads between the electrical connector and of the electrodes to receive an antiseptic current from a driving unit through the electrical connector, the antiseptic current having certain characteristics. Such configuration includes that the patch device does not overheat and is not damaged by the current during use. Such configuration can be done by a person having ordinary skill in the art of medical electrodes and electronics without undue experimentation upon perusal of the description herein.

[0083] The antiseptic current is any type of current including AC (alternating current), DC (direct current) and pulsed DC.

[0084] In some preferred embodiments, the antiseptic current is pulsed DC. The waveform of such a pulsed DC current is any suitable waveform, in some embodiments a waveform selected from the group consisting of a sinusoidal wave, a square wave, a triangle wave, a sawtooth wave and a reverse sawtooth wave. In some preferred embodiments, the waveform is a square wave. In one particularly preferred embodiment, the antiseptic current is pulsed DC having a frequency of not more frequent than about 0.1 Hz and not less frequent than about 10 Hz. In some such embodiments, the frequency is preferably not more frequent than about 0.3 Hz and more preferably not more frequent than 0.5 Hz. Additionally or alternatively, in some such embodiments, the frequency is preferably not less frequent than about 5 Hz and more preferably not less frequent than 2 Hz.

[0085] The potential of the antiseptic current is any suitable potential, typically not less than about 0.1 V and not greater than about 10 V. In some such embodiments, the potential of the current is preferably not less than about 0.2 V and more preferably not less than about 0.5 V. Additionally or alternatively, in some such some embodiments, the potential of the current is preferably not greater than about 8 V and more preferably not greater than about 5 V.

[0086] The intensity of the antiseptic current is any suitable intensity. In some embodiments the intensity of the antiseptic current is not less than about 1 microampere and not more than about 2 milliampere. In some such embodiments, the intensity of the current is preferably not less than about 2 microampere and more preferably not less than about 5 microampere. Additionally or alternatively, in some such embodiments, the intensity of the current is preferably not more than about 1.5 milliampere and more preferably not more than about 1 milliampere.

[0087] In some particularly preferred embodiments, the antiseptic current is:

[0088] - a pulsed DC waveform, preferably selected from the group consisting of a sinusoidal wave, a square wave, a triangle wave, a sawtooth wave and a reverse sawtooth wave;

[0089] - has a frequency of not more frequent than about 0.1 Hz and not less frequent than about 10 Hz;

[0090] - has a potential of not less than about 0.1 V and not greater than about 10 V; and

[0091] - has an intensity of not less than about 1 microampere and not more than about 2 milliampere.

[0092] In some such embodiments the ranges cited for the frequency, potential and intensity are smaller ranges as recited in the immediately-preceding paragraphs, but are not repeated here in the interest of brevity.

[0093] Alternatively, in some preferred embodiments the antiseptic current is DC. In such embodiments, the preferred intensity of the DC current and the preferred potential of the DC current is as recited above for pulsed DC antiseptic current. In some preferred embodiments, the DC current is intermittent DC current that turned on and off during the time that it is desired to have an antiseptic effect. The duty cycle of such an intermittent current is any value from 10% to 90%. In some preferred embodiments, the duty cycle is from about 30% to about 70% and more preferably from about 40% to about 60%, for example a 50% duty cycle. The duration of the "off1state is any duration that is sufficiently short to be insufficient for substantial pathogen development, typically from not less than about 30 seconds to not more than about 60 minutes. Typically, the duration of the "on" state is typically from not less than about 30 seconds to not more than about 60 minutes

[0094] The parameters of the antiseptic current are selected so as not to cause damage to the skin. For example, generally the intensity of the antiseptic current is not more than about 1 milliampere as currents having a greater intensity potentially damage living tissue,

[0095] Physical features of the patch device

[0096] The body of the patch device is preferably conformable, that is to say is flexible to adapt to the shape of a surface.

[0097] As is known in the art of wound dressing, the patch body is typically provided individually-enclosed in a sterile pouch and with a backing covering the lower contact surface of the biocompatible layer. Sterile pouches and backings are well-known in the art of wound dressings.

[0098] In some embodiments when a driving unit is a component of the device, the driving unit is provided inside the same package (e.g., a sterile pouch) as the body of the patch device. In some such embodiments, the driving unit is electrically connected to the electrodes via the electrical connector while in the package. Alternatively, in some such embodiments, the driving unit is not electrically connected to the electrodes via the electrical connector while in the package.

[0099] In some embodiments when a driving unit is a component of the device, the device is provided as a kit, where the driving unit is provided in a package that is different from the package of the body (e.g., a separate sterile or not sterile pouch).

[0100] Patch body with slit and optionally through-hole

[0101] In some embodiments, the patch body includes a slit extending from a perimeter of the patch body to a slit-terminus located at an inner portion of the patch body, the slit having two edges, the slit allowing passing the shaft of a transdermal medical device from the perimeter of the body to the slit terminus while the transdermal medical device is deployed in the body of a living animal. In preferred such embodiments, the slit terminus is flanked by at least two of the electrodes of the patch body. Such a slit is similar to slit found in known split dermal pads

[0102] Such embodiments comprising a slit can be used in a manner similar to the use of a split dermal pad. Specifically, the shaft of a transdermal medical device that is already deployed in a body via a skin opening is passed through the slit between the two slit edges from the perimeter of the patch body to the slit terminus, and then the patch body is moved distally towards the skin surface until the contact surface of the biocompatible layer is in intimate contact with the skin surface that surrounds the skin opening.

[0103] In some embodiments, the slit-terminus is where the slit ends in the patch body. In preferred embodiments, the slit terminus is a through-hole through the biocompatible layer and the electrode-bearing layer that has dimensions to encircle the shaft of a transdermal medical device having a specific size. Such a through-hole is similar or the same as found in known split dermal pads. A through-hole has any suitable shape (typically circular, but in some embodiments a different shape such as a triangle, a square, a pentagon, a hexagon) and any suitable size, typically between about 0.8mm2(equivalent to the surface area of a 0.5 mm radius circle) and about 80 mm2(equivalent to the surface area of a 5 mm radius circle). In some embodiments, a through-hole is sized slightly bigger than the shaft of the transdermal medical device for which it is designed so that when deployed there is a space between the outer surface of the shaft and the through-hole, typical the space being not greater than 2 mm, although incidental contact between the sides of the through-hole and the shaft is generally not precluded. In some embodiments, the through-hole is sized to the same size or smaller than the shaft of the transdermal medical device for which it is designed so that when the patch device is deployed, the sides of the through-hole contact the shaft of the transdermal medical device.

[0104] In some embodiments, when the lower contact surface lays flat on a flat surface the two edges of the slit overlap.

[0105] Alternatively, in some preferred embodiments, when the lower contact surface lays flat on a flat surface, the two edges of the slit are in contact; such embodiments are easy to manufacture.

[0106] Alternatively, in some embodiments, when the lower contact surface lays flat on a flat surface there is a gap between the two edges of the slit, typically not less than about 0.2 mm and not more than about 5 mm. Importantly, in embodiments comprising a slit having a through-hole as the slit terminus, the gap between the two edges of the slit no greater than about 2 / 3 of the width of the through-hole. Any greater-sized gap is considered an inward- directed perimeter as discussed hereinbelow. In preferred such embodiments, the split is flanked by at least two electrodes so that there is an antiseptic effect across the split so that during use of such embodiments there is little concern that pathogens will develop on the uncovered portion of skin that is located in the gap.

[0107] Patch body with through-hole

[0108] In some embodiments, the patch body includes a through-hole passing from an upper surface of the patch body, through the electrode-bearing layer and through the biocompatible layer, the through-hole configured (e.g., in terms of size and, if required, reinforcement) to accommodate the shaft of a transdermal medical device, wherein the through-hole is not associated with a slit in the patch body. Aspects and options of the through-hole are as described above for a through-hole that is a slit-terminus.

[0109] In preferred such embodiments, the slit terminus is flanked by at least two of the electrodes of the patch body.

[0110] In some embodiments, for use the distal end of a transdermal medical device is threaded through the through-hole so that the shaft of the transdermal medical device is encircled by the patch body. The transdermal medical device is deployed distal end first in a body via a skin opening in the usual way. Subsequently, the patch body is moved distally towards the skin surface until the contact surface of the biocompatible layer is in intimate contact with the skin surface that surrounds the skin opening.

[0111] Patch body without slit or through-hole

[0112] In some embodiments, the patch body is a sheet without a through-hole configured to accommodate the shaft of a transdermal medical device and without a slit allowing passing the shaft of a transdermal medical device from the perimeter of the body to the slit terminus while the transdermal medical device is deployed in the body of a living animal.

[0113] In some such embodiments, for use of such patch devices a part of the perimeter of the patch body is found (the patch body may be placed before or after the transdermal medical device) in proximity of (that is to say, very close and even touching) the shaft of a transdermal medical device that is deployed passing into the body through a skin opening with the lower contact surface of the biocompatible layer contacting the skin. In such embodiments, it is preferable to position the electrodes relative to the part of the perimeter that is located close to shaft and to provide an antiseptic current having parameter such that the antiseptic effect of the antiseptic signal extends beyond the perimeter of the patch body to the shaft and to the skin opening. In some embodiments to facilitate such a use, at least a portion of the perimeter of the patch body is directed inward, e.g., is convex or has an interior angle of greater than 180°. During use of such embodiments, it is preferred that the part of the perimeter of the patch device that is found very close to the shaft of the deployed transdermal medical device is the inward-directed portion of the perimeter so that the inward-directed portion of the perimeter partially surrounds the shaft of the transdermal medical device. Importantly, a patch body having a very inward-directed portion is conceptually the same as a patch body discussed above having a very wide slit, i.e., where the gap between the two edges of the slit is no less than about 2 / 3 of the width of an associated through-hole.

[0114] Additionally or alternatively, in some such embodiments, the patch body is configured to allow: cutting the patch body (e.g., with scissors or a scalpel) to make a slit allowing passing the shaft of a transdermal medical device from the perimeter of the body to a slit terminus while the transdermal medical device is deployed in the body of a living animal; and / or perforating the patch body (e.g., with a punch, scissors, scalpel) to make a through- hole passing from the upper surface of the patch body, through the electrode-bearing layer and through the biocompatible layer, the through-hole configured to accommodate the shaft of a transdermal medical device.

[0115] In some embodiments, the configuration of the patch body includes that the electrodes are arranged so that the cutting and / or perforating can be done without substantially damaging the functioning of the electrodes and preferably that the slit terminus and / or through-hole is flanked by two of the electrodes of the patch body.

[0116] In some embodiments, the configuration of the patch body includes markings indicating where the cutting and / or perforating is preferably done, for example, to avoid substantially damaging the functioning of the electrodes.

[0117] In some embodiments, the configuration of the patch body includes reinforcement of the patch body in locations designated for the cutting and / or perforating so that after the cutting and / or perforating the patch body is not easily damaged (e.g., tearing during use)

[0118] Biocompatible layer

[0119] The device comprises a patch body comprising a multilayer sheet, one layer being an electrically-conductive biocompatible layer having a perimeter, a thickness, an upper surface and a lower contact surface. During use, the lower contact surface makes intimate contact with the skin and prevents direct contact of the electrodes with the skin surface. An antiseptic signal is conducted between electrodes having opposite polarity through the biocompatible layer in proximity of the skin surface and as noted along the perimeter of the biocompatible layer and the edge of a through-hole if present.

[0120] The biocompatible layer is made of any suitable material which is electrically- conductive, having a lower contact surface that is not irritating to the skin even for a long period of time and that can conform to a skin surface to achieve intimate contact therewith.

[0121] A person having ordinary skill in the art of wound-dressing is familiar with materials suitable for making such a biocompatible layer upon perusal of the description herein. Particularly suitable materials are electrically-conductive hydrogels, especially hydrogels selected from the group consisting of synthetic hydrogels, natural hydrogels, polysaccharide hydrogels, cotton-derivative hydrogels, carboxymethyl cellulose hydrogels and alginate hydrogels.

[0122] The thickness of the biocompatible layer is any suitable thickness, in some embodiments not less than about 10 micrometers and not more than about 3 mm. In some embodiments, the thickness of the biocompatible layer is preferably not less than about 20 micrometers and more preferably not less than about 30 micrometers. Additionally or alternatively, in some embodiments the thickness of the biocompatible layer is preferably not more than about 1.5 mm and more preferably not more than about 1.2 mm. In some preferred embodiments, the biocompatible layer is particularly thing, being not more than about 1 mm thick and even not more than about 0.5 mm thick.

[0123] It is important to note that most hydrogels are typically poor conductors due to the insulating nature of the hydrophilic polymer chains. However, a person having ordinary skill in the art is able to modify an ordinarily non-conductive hydrogel to be conductive upon perusal of the description herein, for example, by increasing the ionic conductivity of the aqueous phase within the hydrogel.

[0124] In some preferred embodiments, the lower contact surface of the biocompatible layer reversibly adheres to the skin, helping ensure that the patch body remains in place. A person having ordinary skill in the art of wound-dressing is familiar with making a hydrogel more or less skin-adhesive. In some embodiments, the lower contact surface of the biocompatible layer is coated with an electrically-conductive adhesive material.

[0125] In some preferred embodiments, the biocompatible layer comprises one or more antiseptic compositions, for example, compositions comprising chlorhexidine, octenidine, 2- phenoxy ethanol, polyhexanide and / or silver, copper, TiO2or ZnO nanoparticles. In embodiments where the biocompatible layer comprises an electrically-conductive hydrogel, it is possible to impregnate the hydrogel or coat the contact surface with one or more antiseptic compositions.

[0126] Additionally or alternatively, in some embodiments, the biocompatible layer is made of an inherently antiseptic material, for example, an antiseptic hydrogel, see "Antibacterial activity of natural polymer gels and potential applications without synthetic antibiotics" by Hamidi S, Monajjemzadeh F, Siahi-Shadbad M, Khatibi SA and Farjami A in Polymer Engineering & Science 2022, 63(1), 5-21.

[0127] Electrode-bearing layer

[0128] The electrode-bearing layer is a dielectric layer having a perimeter, a thickness, an upper surface and a lower surface, wherein to the lower surface are attached at least two electrodes of a conductive material. The thickness of the electrode-bearing layer is any suitable thickness, typically not less than about 30 micrometers and not more than about 1 millimeter. Suitable materials from which to make the electrode-bearing layer are typically polymers, in some embodiments a polymer selected from the group consisting of polyurethane (PU), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), and polyvinylidene chloride (PVDC).

[0129] The electrodes are of any conductive material that can be applied to the lower surface of the electrode-bearing layer. Examples of suitable conductive materials include but are not limited to silver, copper, gold, aluminum or conductive carbon (e.g., graphite, carbon black). The shape of the individual electrodes is any suitable shape for example, lines, dots, circles, rounds, rectangular, semi-circular, triangular or oval. In some embodiments, all of the electrodes have the same size and shape. In some embodiments, different electrodes have different shapes and / or sizes. The conductive materials can be applied to the lower surface of the electrode-bearing layer using any suitable method, for example, printing of a conductive ink, screen printing and 3D printing. In some preferred embodiments, the electrode-bearing layer is a flexible PCB, as known in the art of electronics. The electrodes are of any suitable thickness, typically not less than about 10 micrometers and not more than about 200 micrometers.

[0130] Suitable combinations of a dielectric electrode-bearing layer material, a conductive electrode material and method of application of the electrode material to the surface of the electrode-bearing layer are well-known to a person having ordinary skill in the art of flexible batteries or in the art of medical electrodes.

[0131] The lower surface of the electrode-bearing layer comprises at least two electrodes that constitute an electrode arrangement. The number of electrodes, the size of each electrode, the shape of each electrode and the relative position of the electrodes of the electrode arrangement are any suitable combination of number, size, shape and relative position that provides a sufficient antiseptic signal through the biocompatible layer to the skin surface which the biocompatible layer contacts.

[0132] The electrode arrangement has an outer perimeter which is an imaginary closed curve that surrounds the electrodes of the electrode arrangement although in some embodiments a patch body comprises markings indicating the outer perimeter. Further, in embodiments having a through-hole, the electrode arrangement has an inner perimeter which is an imaginary closed curve that encircles the through-hole. As noted above, the antiseptic effect of an antiseptic signal extends outwards beyond the outer perimeter of the biocompatible layer, typically by at least one 1 mm and even by at least 2 mm. Additionally, the antiseptic effect of an antiseptic signal extends inwards beyond the edge of a through-hole, typically by at least one 1 mm and even by at least 2 mm, towards and even including the skin opening and the shaft of transdermal medical device that are not in physical contact with biocompatible layer.

[0133] The shape of the electrode arrangement is any suitable shape, for example a circle, a rectangle, a square, an oval, or a cross. In some typical embodiments, the shape of the electrode arrangement is a circle.

[0134] In some embodiments where the patch body comprises a slit, a portion of the perimeter of the electrode arrangement is close to (not more than about 2 mm, preferably not more than about 1 mm, more preferably not more than about 0.5 mm and in some embodiments is even colocated with) the edges of the slit.

[0135] In some embodiments where the patch body comprises a through-hole, a portion of the perimeter of the electrode arrangement is close to (not more than about 2 mm, preferably not more than about 1 mm, more preferably not more than about 0.5 mm and in some embodiments is even colocated with) the edge of the through-hole.

[0136] In some embodiments where the patch body is devoid of a slit and / or through hole, for example some embodiments where the patch body comprises an inward-directed perimeter, a portion of the perimeter of the electrode arrangement is close to (not more than about 2 mm, preferably not more than about 1 mm, more preferably not more than about 0.5 mm and in some embodiments is even colocated with) the perimeter of the patch body.

[0137] The size of the electrode arrangement is any suitable size. In some preferred embodiments, the surface area of the electrode arrangement is not less than about 0.88 cm2(equivalent to the area of a circle having a 1 cm diameter) and not more than about 80 cm2(equivalent to the area of a circle having a 10 cm diameter).

[0138] In some embodiments, the perimeter of the electrode arrangement and of the electrode-bearing layer are the same. In preferred embodiments, the perimeter of the electrode-bearing layer is larger than the perimeter of the electrode arrangement so that the portions of the electrode-bearing layer that are beyond the perimeter of the electrode arrangement surround the electrode arrangement with a dielectric border.

[0139] In some embodiments, the perimeter of the electrode arrangement and of the biocompatible layer are the same. In preferred embodiments, the perimeter of the biocompatible layer is larger than the perimeter of the electrode arrangement so that the portions of the biocompatible layer that are beyond the perimeter of the electrode arrangement carry the antiseptic signal outwards.

[0140] The electrodes of the electrode arrangement cover any suitable portion of the area of the electrode arrangement. Typically, not less than about 25% and not more than about 75% % of the surface area of the electrode arrangement is covered by electrodes, more preferably not less than about 30% and even more preferably not less than about 50%.

[0141] The distance between a given electrode and a neighboring electrode of the opposite polarity is any suitable distance. In some typical embodiments, the distance is not less than about 0.5 mm and not more than about 4 cm.

[0142] Outer cover layer

[0143] As known in the art, a dermal pad typically comprises an outer cover layer that helps prevent the pad from physical damage and prevents contamination of an underlying biocompatible layer from above, inter alia, from airborne contamination and from contamination from physical contact, for instance by medical staff, with the pad. In preferred embodiments, a patch body of a patch device according to the teachings herein comprises an outer cover layer.

[0144] Electrode-bearing layer is the outer cover layer

[0145] In some embodiments of the teachings herein, the electrode-bearing layer is the outer cover layer of the patch body. In such embodiments, the materials and properties of the electrode layer are similar or identical to those known in the art of wound dressing, for example as known in dermal pads. An advantage of some such embodiments is that the patch body has fewer components. A disadvantage of some such embodiments is that in some instances it may be challenging to find a material which has the desired electrode-bearing properties, adhesion to the biocompatible layer and protective properties required from a outer cover layer.

[0146] In some embodiments where the electrode-bearing layer is the outer cover layer of the patch body, the perimeter of the biocompatible layer and the perimeter of the electrodebearing layer are the same size and shape. In preferred such embodiments, the perimeters of biocompatible layer and of the electrode-bearing layer overlap and together define the perimeter of the patch body.

[0147] In some embodiments where the electrode-bearing layer is the outer cover layer of the patch body, the perimeter of the biocompatible layer is larger than the perimeter of the electrode-bearing layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the biocompatible layer extend outwards from beneath the perimeter of the electrode-bearing layer. In some such embodiments, the perimeter of the biocompatible layer defines the perimeter of the patch body. In some preferred embodiments where the electrode-bearing layer is the outer cover layer of the patch body, the perimeter of the electrode-bearing layer is larger than the perimeter of the biocompatible layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the electrode-bearing layer extend outwards beyond the perimeter of the biocompatible layer and overhang the biocompatible layer. The lower surfaces of the overhanging portions typically contact the skin. In preferred such embodiments, all of the electrodes of the electrode-bearing layer are located within the bounds of the perimeter of the biocompatible layer. In typical such embodiments, the perimeter of the electrode-bearing layer defines the perimeter of the patch body.

[0148] Outer cover layer different from the electrode-bearing layer

[0149] In some embodiments of the teachings herein, the patch body comprises an additional outer cover layer different from the electrode-bearing layer, the outer cover layer having a perimeter, a thickness, an upper surface and a lower surface, the lower surface of the outer cover layer facing the upper surface of the electrode-bearing layer. In such embodiments, the materials and properties of the outer cover layer are similar or identical to what is known in the art of wound dressing, for example as known in dermal pads. An advantage to such embodiments is ease of industrial-scale manufacture and allowing independent selection of the material from which to make a outer cover layer having the desired protective properties and material having the desired electrode-bearing properties.

[0150] In some embodiments, the lower surface of the outer cover layer intimately contacts the upper surface of the electrode-bearing layer. In some such embodiments, the outer cover layer and the electrode-bearing layer are held together, inter alia, by electrostatic forces.

[0151] In some embodiments, there is an additional layer between the lower surface of the outer cover layer and the upper surface of the electrode-bearing layer. In some such embodiments, the additional layer is an adhesive layer that holds the two layers together.

[0152] The thickness of such a outer cover layer is any suitable thickness, typically not less than about 100 micrometers and not more than about 1 millimeter. Suitable materials from which to make such a outer cover layer are typically polymers similar or identical to what is known in the art of wound dressing, for example as known in dermal pads. In some embodiments the outer cover layer is made of a polymer selected from the group consisting of polyurethane (PU), polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), and polyvinylidene chloride (PVDC). The factors for selecting a specific material is suitably for functioning as a outer cover layer and adhesion to the underlying layers.

[0153] In preferred embodiments having a outer cover layer that is different from the electrode-bearing layer, the perimeter of the outer cover layer defines the perimeter of the patch body.

[0154] In some embodiments having a outer cover layer that is different from the electrodebearing layer, the perimeters of the outer cover layer, of the electrode-bearing layer and of the biocompatible layers are the same size and shape. In preferred such embodiments, the perimeters of the outer cover layer, of the biocompatible layer and of the electrode-bearing layer overlap and together define the perimeter of the patch body.

[0155] In some embodiments having a outer cover layer that is different from the electrodebearing layer, the perimeter of the biocompatible layer is larger than the perimeter of the electrode-bearing layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the biocompatible layer extend outwards from beneath the perimeter of the electrode-bearing layer. In typical such embodiments, at least part of the outer portion of the bottom surface of the outer cover layer contacts the outer portion of the upper surface of the biocompatible layer. In some such embodiments, the perimeters of the outer cover layer and of the biocompatible layers are the same size and shape. In preferred such embodiments, the perimeters of the outer cover layer of and of the biocompatible layer overlap and together define the perimeter of the patch body. Alternatively, in some such embodiments the perimeter of the outer cover layer is larger than the perimeter of the biocompatible layer so that when the patch is in use and the biocompatible layer is contacting a skin surface, portions of the outer cover layer extend outwards beyond the perimeter of the biocompatible layer and overhang the biocompatible layer and the electrode-bearing layer. The lower surface of the overhanging portions of the outer cover layer typically contact the skin. In preferred such embodiments, the lower surface of the overhanging portions of the outer cover layer is devoid of an adhesive. In some preferred embodiments, the lower surface of the overhanging portions of the outer cover layer comprise an adhesive to adhere the overhanging portions to a skin surface, thereby assisting in maintaining the patch body in place during use.

[0156] In some embodiments having a outer cover layer that is different from the electrodebearing layer, the perimeter of the electrode-bearing layer is larger than the perimeter of the biocompatible layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the electrode-bearing layer extend beyond the perimeter of the biocompatible layer. In some such embodiments, the perimeters of the outer cover layer and of the electrode-bearing layers are the same size and shape. In preferred such embodiments, the perimeters of the outer cover layer of and of the electrode-bearing layer overlap and together define the perimeter of the patch body and typically have a portion that overhangs the biocompatible layer when the biocompatible layer contacts skin.

[0157] Alternatively, in some such embodiments the perimeter of the outer cover layer is larger than the perimeter of the electrode-bearing layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the outer cover layer extend outwards beyond the perimeter of the biocompatible layer and of the electrode-bearing layer and overhang the biocompatible layer and the electrode-bearing layer. In some embodiments, a portion of the electrode-bearing layer overhangs the biocompatible layer, and a portion of the outer cover layer overhangs the electrode-bearing layer. The lower surface of the overhanging portions typically contact the skin. In preferred such embodiments, the lower surfaces of the overhanging portions are devoid of an adhesive. In some preferred embodiments, the lower surfaces of the overhanging portions comprise an adhesive to adhere the overhanging portions to a skin surface, thereby assisting in maintaining the patch body in place during use.

[0158] Overhanging portions

[0159] As noted above, in some embodiments where the electrode-bearing layer is the outer cover layer of the patch body, the perimeter of the electrode-bearing layer is larger than the perimeter of the biocompatible layer so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the electrode-bearing layer extend outwards and overhang the biocompatible layer. Similarly, in some embodiments having a outer cover layer different from the electrode-bearing layer, the perimeter of the outer cover layer is larger than the perimeters of the electrode-bearing layer and of the biocompatible layer, so that when the patch device is in use and the biocompatible layer is contacting a skin surface, portions of the outer cover layer extend outwards and overhang the biocompatible layer and the electrode-bearing layer.

[0160] The lower surface of the overhanging portions (of the electrode-bearing layer or of the outer cover layer) typically contact the skin during use of the patch device.

[0161] In some embodiments, the lower surfaces of the overhanging portions of the electrode-bearing layer are devoid of an adhesive. In some preferred embodiments, the lower surfaces of the overhanging portions of the electrode-bearing layer comprise an adhesive to adhere the overhanging portions to a skin surface, thereby assisting in maintaining the patch body in place during use.

[0162] Dislodgement sensor

[0163] In some embodiments, a patch device according to the teachings herein includes a dislodgement sensor to identify if the patch body that has been placed on skin has been dislodged. A dislodgement sensor is an assembly that, when a patch device that is being used and the patch body has been positioned on a skin surface, generates a signal indicating when the patch body has moved from the position. Upon receiving such a signal, a person (such as a health-care professional) can take action required from such movement.

[0164] Any suitable type of dislodgement sensor can be used. In one preferred embodiments, the dislodgement sensor comprises electrodes that contact the skin to measure the impedance (including just resistance) of the skin between the two electrodes and a controller typically comprising a microprocessor. The electrodes are placed on the skin when the patch body is positioned on the skin and the impedance of the skin is measured as a reference. While the patch device is being used, the controller uses the electrodes to monitor (e.g., continuously, periodically, intermittently) the impedance. If the impedance substantially changes (i.e., indicative of dislodgement of the patch body rather than perspiration), the microprocessor generates a warning signal. What constitutes a "substantial change in skin impedance" can be easily determined by a person having ordinary skill in the art without undue experimentation or inventive effort for a given dislodgement sensor, for example, by standard experimentation.

[0165] The warning signal is any suitable type or combination of types of signals including auditory signals (e.g., an alarm generated using a speaker), visible signals (e.g., an visible alarm such as a flashing red light) and transmitted signals (e.g., a signal that is received by a beeper, telephone or medical monitor of a person). Suitable controllers and electrodes that can be modified to implement a dislodgement sensor are known in the art, see for example, Screentec Wearable Patches by PalmSens BV (Houten, The Netherlands).

[0166] In some preferred embodiments of the patch body that include an overhanging portion (e.g., of the outer cover layer and / or the electrode-bearing layer) one or more overhanging portions bear the electrodes of the dislodgement sensor. In some such embodiments, the overhanging portions include an adhesive to help secure the overhanging portions, and thereby the patch body, to the skin. In some such embodiments, the adhesive on the overhanging portion is an electrically-conductive adhesive to ensure that the electrodes make sufficient electrical contact with the skin.

[0167] In some such embodiments, the controller of the dislodgement sensor is a dedicated controller. In preferred embodiments, the driving unit comprises the controller of the dislodgement sensor.

[0168] An embodiment of the patch device according to the teachings herein, a patch 100 is schematically depicted in Figure 1 A (schematic view from the top) and Figure IB (schematic side cross section). Patch 100 comprises a circle-shaped patch body 102 including a slit 104 extending from a perimeter 106 of patch body 102 to a slit-terminus, a through-hole 108. A driving unit 110 (comprising a battery and a microprocessor configured, inter alia, as a waveform generator) is in electrical communication with electrodes 112a, 112b and 112c through electrical connector 114. Electrodes 112a and 112c are in electrical communication with the positive outlet of driving unit 110 and electrode 112b is in electrical communication with the negative outlet of driving unit 110.

[0169] In Figure IB is seen that patch body 102 comprises three layers: a biocompatible layer 116 having a lower contact surface 116a; an electrode-bearing layer 118 to which lower surface are attached electrodes 112a, 112 and 112c (indicated with reference 112 due to the schematic nature of Figure IB); and a outer cover layer 120 different from electrode-bearing layer 118.

[0170] Perimeter 106 of patch body 102 of patch 100 is defined by the perimeter of outer cover layer 120. The perimeters of electrode-bearing layer 118 and biocompatible layer 116 are the same and smaller than perimeter 106 of outer cover layer 120 but larger than the perimeter of the electrode arrangement which is defined by the outer perimeter of electrode 112a

[0171] When driving unit 110 is activated to provide an antiseptic current that flows from positive electrode 112b to negative electrodes 112a and 112c through biocompatible layer 116, an antiseptic signal is produced in biocompatible layer 116 which antiseptic signal has an antiseptic effect in the interface between lower contact surface 116a and a skin surface in contact therewith.

[0172] A patch device 122 is depicted in schematic side cross section in Figure 2. In patch device 122, electrode-bearing layer 118 also functions as a outer cover layer and has a perimeter that is larger than the perimeter of biocompatible layer 116. A patch device 124 is depicted in schematic side cross section in Figure 3. In patch device 124, the perimeter of outer cover layer 120 and the perimeter of electrode-bearing layer 118 are the same, both being larger than the perimeter of biocompatible layer 116. Additionally, patch device 124 includes electrodes 126 that are components of a dislodgement sensor. In patch 124, driving unit 110 is also configured to function as the controller for the dislodgement sensor.

[0173] A patch device 128 is depicted in schematic top view in Figure 4. In patch device 128, patch body 102 is square-shaped. The perimeter of the electrode arrangement is also square. The electrode arrangement comprises multiple circular small electrodes arranged in a 14 x 14 square matrix, although six electrodes are missing from the matrix due to the presence of slit 104 and another twelve are missing from the matrix due to the presence of through-hole 108.

[0174] A patch device 130 is depicted in schematic top view in Figure 5. Patch 130 is similar to patch 128 depicted in Figure 4 and also includes multiple circular small electrodes 112 arranged in a square matrix. Unlike patch 128, patch body 102 of patch 130 is circular as is the perimeter of the electrode arrangement.

[0175] A patch device 132 is depicted in schematic top view in Figure 6A. Patch 132 is similar to patch 130 depicted in Figure 5 and also includes multiple circular small electrodes 112 arranged in a square matrix, where the perimeter of the electrode arrangement is a circle. Although not explicitly seen in Figure 6, the perimeter of the electrode arrangement, the perimeter of the biocompatible layer and the perimeter of the electrode-bearing are all substantially the same size, patch device 132 comprises a outer cover layer 120 that is different from the electrode-bearing layer, outer cover layer 120 having a cruciform perimeter with rounded inner vertices. The lower surfaces of the "arms" of the cross are covered with a skin-adhesive to assist in keeping patch device 132 firmly in place. Also found on the lower surface of the "arms" of the cross are electrodes 126 of a dislodgement sensor, substantially as described for patch 124 depicted in Figure 3.

[0176] In Figure 6B, is depicted a transdermal medical device, cannula 134 which shaft 134a enters a skin surface through an entry hole in the skin so that a proximal end 134b of shaft 134a is located outside the body and a distal end 134c of shaft 134a is located inside the body, patch device 132 is positioned so that lower contact surface 116a of the biocompatible layer of patch body 102 is in intimate contact with the skin surface. Patch 132 is positioned so that through-hole 108 encircles shaft 134a. In Figure 6B, through-hole 108 is slightly smaller than shaft 134a so that portions of lower contact surface 116a curve upwards and make physical contact with the outer surface of shaft 134a. According to aspect of some embodiments of the teachings herein, there is provided a method for reducing the incidence of infections associated with the insertion site of a transdermal device (for example, infections in proximity of the shaft of the transdermal medical device, infections in the skin opening and / or transdermal passage, development of a biofilm in the skin), the method comprising: i. deploying a transdermal medical device in the body of a living animal so that the shaft of the transdermal medical device penetrates into a skin opening through a transdermal passage so that a distal end of the shaft is located inside the body and a proximal end of the shaft is located outside of the body, box 210 in Flowchart 200 depicted in Figure 7; ii. placing a patch body of a patch device as described herein with a perimeter of the patch body in proximity of the location of the skin opening and so that the lower contact surface of the biocompatible layer of the patch body makes intimate contact with the skin surface of the living animal, box 220 in Flowchart 200 depicted in Figure 7; iii. subsequently to both 'i' and 'ii', activating a driving unit that is functionally- associated with the electrodes of the patch body through the electrical connector of the patch device to provide an antiseptic electrical current to the electrodes, thereby producing an antiseptic signal in the biocompatible layer that has an antiseptic effect at the interface between the skin surface and the contact surface of the biocompatible layer, box 230 in Flowchart 200 depicted in Figure 7, the antiseptic signal thereby decreasing (and in some embodiments, preventing) the development of a biofilm and / or pathogens on the skin surface and in proximity of the perimeter of the patch body. As a result of the antiseptic signal decreasing the development of a biofilm and / or pathogens on the skin surface and in proximity of the perimeter of the patch body, there is a reduction in the incidence and even elimination of infections associated with the insertion site of the transdermal device.

[0177] In some embodiments, the animal is a human. In some embodiments, the animal is a non-human animal.

[0178] In some embodiments, the shaft of the transdermal medical device is a tube. In some embodiments, the transdermal medical device is selected from the group consisting of a cannula and a catheter, in some preferred embodiments, the cannula or the catheter provide fluid communication with the lumen of a vein. In some embodiments, the transdermal medical device is a drainage tube.

[0179] In some embodiments, deploying the transdermal medical device 'i' is done prior to placing the patch body 'ii', see in Figure 7 the flow of al to a2 to a3. For example, in some embodiments where the patch body has a slit, placing the patch body 'ii' comprises passing the shaft of the deployed transdermal medical device from the perimeter of the patch body to the slit terminus and, if required, moving the patch body distally along the shaft towards the skin surface until the lower contact surface of the biocompatible layer is in intimate contact with the skin surface that surrounds the skin opening.

[0180] In some embodiments, deploying the transdermal medical device 'i' is done subsequent to placing the patch body 'ii', see in Figure 7 the flow of bl to b2 to b3. Such embodiments are exceptionally suitable when the patch body is devoid of both a slit and a through-hole and especially where the patch body perimeter comprises an inward directed portion, the method comprises placing the patch body so that the perimeter is in proximity of the location of the skin opening (irrespective of whether the skin opening is present at the location or whether the skin opening will be made during 'i') and subsequently deploying the transdermal medical device distal end first in the body.

[0181] In some embodiments, deploying the transdermal medical device 'i' and placing the patch body 'ii' are done concurrently, see in Figure 7 the flow of cl to c3. Such embodiments are exceptionally suitable when the patch body comprises a through-hole but is devoid of a slit. For example, in some such embodiments the method comprises: threading the distal end of the transdermal medical device through the through-hole of the patch body so that the shaft of the transdermal medical device is encircled by the patch body; subsequently deploying the transdermal medical device distal end first in the body via a skin opening; and subsequently moving the patch body distally along the shaft towards the skin surface until the lower contact surface of the biocompatible layer is in intimate contact with the skin surface that surrounds the skin opening.

[0182] In 'ii' is recited that a perimeter of the patch body is placed in proximity of the location of the skin opening. In some embodiments, the perimeter is the outer perimeter of the patch body. Alternatively, in some embodiments, the perimeter is the perimeter of a through-hole or slit-terminus. The "proximity"is that the distance between the perimeter of the patch body and the location of the skin opening is such that an antiseptic effect will be achieved on the skin surface near the skin opening during 'iii'. In some embodiments, by "placing in proximity"is intended as close as possible to the location of the skin opening. In some embodiments, by "placing in proximity"is intended not more than about 6 mm from the location of the skin opening, preferably not more than about 3 mm from the location of the skin opening and even more preferably not more than about 2 mm from the location of the skin opening.

[0183] In some embodiments, a patch body including a slit is preferably placed so that the shaft of the transdermal medical device is located at the slit-terminus of the patch body. In embodiments of the patch device having a through-hole the patch body is preferably placed so that the shaft of the device is located in the through-hole of the patch body.

[0184] In some embodiments, no part of the shaft is in contact with the patch body. In preferred embodiments, at least part of the shaft is in contact with the patch body. In even more preferred embodiments, the patch body contactingly-encircles the shaft, thereby constituting a physical barrier to fluid communication from a portion of the shaft above patch body and a portion of the shaft below the patch body.

[0185] In embodiments where the patch body includes a through-hole but is devoid of a slit, the patch body is placed so that the shaft of the transdermal medical device is encircled by the through-hole. Such an embodiment is depicted in Figure 8A, where a patch device 136 comprises a patch body 102, an electrode arrangement 138 with a perimeter 140 and a through-hole 108 which encircles shaft 134a of a cannula. In such embodiments, the antiseptic effect of the antiseptic signal extends from the edges of the through-hole inwards to also cover portions of skin and portions of the shaft that are not in direct contact with the contact surface of the biocompatible layer, if such exist.

[0186] In embodiments where the patch body includes a slit and no through-hole, the patch body is placed so that the shaft of the transdermal medical device is at the slit-terminus and the edges of the patch body are wrapped around the shaft. Such an embodiment is a patch device 142, depicted in Figure 8B. In such embodiments, the antiseptic effect of the antiseptic signal extends from the edges of the through-hole inwards to also cover portions of skin and portions of the shaft that are not in direct contact with the contact surface of the biocompatible layer, if such exist.

[0187] In embodiments where the patch body includes a through-hole and a relatively wide slit, the patch body is placed so that the shaft of the transdermal medical device is encircled by the through-hole. Such an embodiment is a patch device 144, depicted in Figure 8C. In such embodiments, the antiseptic effect of the antiseptic signal extends from the edges of the slit inwards to also cover portions of skin and of the shaft that are not in direct contact with the contact surface of the biocompatible layer.

[0188] Patch device 146 depicted in Figure 8D is similar to patch device 144 depicted in Figure C except that the "slit" is as wide as through-hole 108 and is therefore considered herein to be an inward-directed portion 148 of perimeter 106 of patch body 102. In such embodiments, the antiseptic effect of the antiseptic signal extends from the perimeter (edges) of inward-directed portion 148 inwards to also cover portions of skin and of the shaft that are not in direct contact with the contact surface of the biocompatible layer.

[0189] In some embodiments, a patch body is devoid of a slit, through-hole or inward- directed perimeter. In some such embodiments, the patch device is configured to allow a user to make a slit, through-hole and / or inward-directed portion in the patch body (e.g., with a scissors, a scalpel, a punch) without damaging the electrode arrangement. Additionally or alternatively, some such embodiments are used by placing a portion of a perimeter of the patch body in proximity of the location of the skin opening and of the shaft 134a. To this end, in some embodiments, at least a portion of the perimeter of the electrode arrangement is very close (in some embodiments closer than about 2 mm, preferably closer than about 1 mm) to a portion of the perimeter of the patch body. Such an embodiment is patch device 150 depicted in Figure 8E.

[0190] In some embodiments, a patch-body comprises an inward-directed portion which size is sufficient to encircle only a portion of the shaft of a transdermal medical device. In some such embodiments, the portion is less than about 80% of the perimeter of the shaft and even less than about 60% of the perimeter of the shaft. In such embodiments, the patch is preferably placed so as to partially-encircle the shaft. Such an embodiment is patch device 152 depicted in Figure 8F comprises a square patch body 102 with an inward-directed portion 148 of perimeter 106 of patch body 102 in the shape and dimensions of half of the perimeter of shaft 134a.

[0191] In some embodiments of a patch body devoid of a slit, through-hole or inward- directed portion of the perimeter (such as device 150 of Figure 8E) or of a relatively small inward-directed portion (such as device 152 of Figure 8F) the dimensions of the shaft, the construction of the patch body and the nature of the antiseptic current are such that the antiseptic effect of the antiseptic signal extends sufficiently far from the perimeter close to the shaft to also cover a sufficiently large portion of skin and of the shaft to be clinically effective. In some alternative embodiments, at least two patch devices are used together with a single transdermal medical device by placing the two respective patch bodies to surround the shaft of the transdermal medical device. With embodiments having a relatively small inward-directed portion (such as device 152 of Figure 8F), complete or almost complete encirclement of the shaft can be achieved. In some such embodiments, each patch device is functionally-associated driving unit. In alternative such embodiments, at least two patch devices are functionally-associated with a single driving unit.

[0192] In some embodiments, a patch-body comprises an inward-directed portion which size is relatively large compared to the size of the shaft of the transdermal medical device. Such embodiments include device 154 depicted in Figure 8G and device 156 depicted in Figure 8H. In some such embodiments the dimensions of the shaft, the construction of the patch body and the nature of the antiseptic current are such that the antiseptic effect of the antiseptic signal extends sufficiently far from the perimeter or the inward-directed portion of the patch body perimeter to also cover a sufficiently large portion of skin and of the shaft to be clinically effective. In some embodiments, the antiseptic effect covers only a portion of the skin and / or shaft, but does provide easy access for medical personnel to treat uncovered portions of skin.

[0193] In some embodiments, subsequent to placing the patch body, the method further comprises applying an IV dressing over the patch body to assist in maintaining the patch body and the transdermal medical device in place. In some embodiment, such applying an IV dressing is similar or the same as known in the art, for example, applying Tegaderm IV dressing from 3M, St Paul, Minnesota, USA.

[0194] In some embodiments, the method further comprises placing a dislodgement sensor associated with the patch device to monitor (e.g., continuously, periodically and / or intermittently) that the patch body does not move and, if movement is detected the dislodgement sensor generates a warning signal. In some preferred embodiments, the dislodgement sensor monitors the skin impedance and, identifying a substantial change in the skin impedance as movement of the patch body. In some embodiments, the dislodgement sensor is a component of the patch device, as described above.

[0195] In some embodiments, a portion of the outer surface of the shaft of the transdermal medical device that is located outside of the body of the animal is electrically-conductive and the method further comprises: placing the electrically-conductive portion of the outer surface of the shaft in an electrical circuit configured to carry an antiseptic electrical current; providing an antiseptic electrical current to the electrically-conductive portion of the outer surface of the shaft through the circuit to produce an antiseptic signal at the electrically-conductive portion of the outer surface of the shaft, the antiseptic signal having an antiseptic effect on the shaft and, in some embodiments, in at least part of the opening in the skin, thereby preventing the development of a biofilm and or pathogens on at least a portion of the shaft and in the opening of the skin.

[0196] In some embodiments, the electrically-conductive portion of the outer surface of the shaft is inherent to the construction of the shaft, e.g., a purpose-built shaft having a conductive portion. In some embodiments, a conductive coating is applied to a non- conductive shaft prior to implementing the teachings herein, for example, application of a conductive adhesive such as HiDow Conductive Adhesive Spray (HiDow International, Maryland Heights, MO, USA). In some embodiments, a conductive element, such as a wire ring, clamp or clasp of conductive material such as a metal is attached to the shaft.

[0197] In some embodiments, the electrical circuit that includes the electrically-conductive portion of the outer surface of the shaft is an electrical circuit independent of other portions of the patch device, inter alia, includes an own driving unit.

[0198] Alternatively, in some such embodiments, the electrical circuit that includes the electrically-conductive portion of the outer surface of the shaft is an electrical circuit independent of other portions of the patch body, for example, comprises leads and electrical connectors that connect directly to the driving unit of the patch device.

[0199] Alternatively, in some such embodiments, the patch body comprises a second electrical connector configured specifically to direct an antiseptic current received from a driving unit via the electrical connector to the electrical circuit that includes the electrically- conductive portion of the outer surface of the shaft

[0200] Alternatively, in some such embodiments, at least some of the electrodes of the patch body are configured so that when the patch device is deployed in a human with a transdermal medical device passing through the patch body, one, two or more selected electrodes (in some preferred embodiments, electrodes that are apparent on the edges of the slit and / or through- hole) of the patch body contact the electrically-conductive portion of the outer surface of the shaft so that the electrodes are part of the circuit and the electrically-conductive portion of the outer surface of the shaft receives the antiseptic current from a driving unit connected to the patch body through the electrical connector and through the selected electrodes.

[0201] In some embodiments where the antiseptic current is AC, the circuit is an open AC circuit and the electrically-conductive portion of the outer surface of the shaft acts as an antenna that radiates an antiseptic oscillating electric field.

[0202] In preferred embodiments, the circuit is a closed circuit. In some such embodiments, the electrically-conductive portion of the outer surface of the shaft is part of a closed circuit with one or more of the electrodes of the patch body through the biocompatible layer. Conductive Element

[0203] In some embodiments, a patch device according to the teachings herein further comprises a conductive element, the conductive element configured to be attached to the shaft of a transdermal medical device and also configured to receive an antiseptic current from an electrical power source.

[0204] The shape of the conductive element is any suitable shape, for example, a ring, a clamp, a clip or a clasp of conductive material that can encircle, clamp or clasp the shaft. The conductive element is made of any suitable conductive material, for example a metal such as silver, gold, copper, zinc or combinations thereof. Additionally or alternatively, the conductive element comprises a conductive coating, for example, of conductive nanoparticles or conductive polymers.

[0205] In some embodiments, the conductive element is configured to receive an antiseptic current from a source that is not the driving unit that provides an antiseptic current to the electrodes of the patch body of the patch device.

[0206] In preferred embodiments, the conductive element is configured to receive an antiseptic current from the same source as the electrodes, i.e., a driving unit that is functionally-associated with the electrical connector of the path device. In some such embodiments, the conductive element is electrically-associated with the electrical connector, in some such embodiments through a dedicated lead and in some alternative embodiments through one or more of the electrodes. Alternatively, in some embodiments, the patch device comprises a second electrical connector dedicated to connect to the driving unit to provide electrical communication between the conductive element and the driving unit.

[0207] For use, before or after the patch device has been placed as described herein so that the shaft of the transdermal medical device is located in proximity of a perimeter of the patch body, the conductive element is attached to a proximal portion of the shaft of the transdermal shaft that extends out from the skin surface. An antiseptic current is provided to the conductive element together with providing the antiseptic current to the electrodes, thereby also producing an antiseptic signal on the outer portion of the shaft.

[0208] In Figure 8 is depicted the use of a conductive element 158, a metal clasp, as described above together with a patch 100 discussed with referenced to Figures 1 and a catheter 134.

[0209] In some embodiments, conductive element 158 is a component of catheter 134 and is correctly positioned during deployment of catheter 134.

[0210] Additionally or alternatively, in some embodiments, conductive element 158 is a component of patch 100.

[0211] In some embodiments, conductive element 158 is in wired electrical connection with driving unit 110, either through a dedicated lead (not depicted) or through at least one of electrodes 112a, 112b and / or 112c.

[0212] In some embodiments, conductive element 158 is a component of neither patch 100 nor of catheter 134, but is a separate component.

[0213] Conductive element 158 and patch 100 are positioned around a proximal portion 134b of the shaft of catheter 134 in any suitable order so that conductive element 158 encircles proximal portion 134b of the shaft and is encircled by through-hole 108 of patch body 102. When driving unit 110 is activated an antiseptic current passes to electrodes 112a, 112b and 112c. In embodiments where conductive element 158 is electrically-connected to driving unit 110, the antiseptic current also passes to conductive element 158. In embodiments where there is no such electrical-connection to driving unit 110, an antiseptic electrical signal also passes into conductive element 158 through lower contact surface 116a of the biocompatible layer of patch 100 which is in electrical communication with conductive element 158.

[0214] EXPERIMENTAL

[0215] Experiments are performed to demonstrate the efficacy of the teachings herein.

[0216] Experiment 1 : in vitro antiseptic efficacy of a patch device

[0217] In an in-vitro experimental setup, the antiseptic efficacy of a patch device according to the teachings herein is evaluated.

[0218] A catheter is inserted into each one of two agar plates uniformly inoculated with a known concentration (e.g., 3 x 106CFU / mL) of Staphylococcus aureus SAI 13.

[0219] A patch device comprising an electrode arrangement having a 2.5 cm x 2.5 cm perimeter and similar to the electrode arrangement of patch 128 as depicted in Figure 4 is placed around each one of the two catheters as described above, so that the catheter tubes are encircled the through-hole of the patch body without direct contact with the patch body.

[0220] An antiseptic current is provided to the electrodes of one of the two patch devices.

[0221] In the agar plate where no antiseptic current is provided to the electrodes of the patch, the bacteria develops normally.

[0222] In the agar plate where an antiseptic current is provided to the electrodes of the patch, complete eradication of the bacteria is observed after 24 hours underneath the patch body and also in a zone extending outwards at least 4 mm from the perimeter of the patch. Experiment 2: in vitro antiseptic effect against s. aureus SAI 13 along a simulated catheter

[0223] In an in-vitro experimental setup, the antiseptic efficacy of a patch device according to the teachings herein to prevent biofilm formation on the shaft of a medical device is evaluated.

[0224] A catheter tube is inserted into each one of two agar plates. A patch device comprising an electrode arrangement having a 2.5 cm x 2.5 cm perimeter and similar to the electrode arrangement of patch 128 as depicted in Figure 4 is placed around each one of the two catheters as described above so that the catheter tubes are encircled the through-hole of the patch body without direct contact with the patch body.

[0225] 40 microliters of a suspension of s. aureus SAI 13 at a known concentration (e.g., 3.5 x 104CFU / mL) is applied along the length of the two catheter tubes.

[0226] An antiseptic current is provided to the electrodes of one of the two patch devices.

[0227] In the agar plate where no antiseptic current is provided to the electrodes of the patch device, the bacteria develops normally including on the catheter shaft.

[0228] In the agar plate where an antiseptic current is provided to the electrodes of the patch device, no bacteria is observed on the shaft, underneath the patch device and in a zone extending outwards at least 4 mm from the perimeter of the patch body.

[0229] Experiment 3: in vitro antiseptic effect against s. aureus SAI 13 along a simulated catheter

[0230] A 9 cm x 9 cm square sample of porcine skin is placed in each one of two Petri dishes, outer side up.

[0231] A suspension of Pseudomonas aeruginosa bacteria having a known concentration (e.g., 105CFU / mL) is applied to the upwards-facing outer surface of both skin samples.

[0232] A patch device comprising an electrode arrangement having a 2.5 cm x 2.5 cm perimeter and similar to the electrode arrangement of patch 128 as depicted in Figure 4 is placed on top of both of the porcine skin samples covering the applied bacterial suspension.

[0233] An antiseptic current is provided to the electrodes of one of the two patch devices.

[0234] In the Petri dish where an antiseptic current is not provided to the electrodes of the patch device, a biofilm of Pseudomonas aeruginosa develops on the skin, including in the interface between the contact surface of the patch body and the skin surface.

[0235] In the Petri dish where an antiseptic current was provided to the electrodes of the patch device, no bacteria were observed on the skin underneath the patch body and also not in a zone extending outwards at least 2 mm from the perimeter of the patch body. It is clear that the description of the embodiments and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope. It is also clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the claims.

[0236] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. In case of conflict, the specification, including definitions, takes precedence.

[0237] As used herein, the terms “comprising”, “including”, "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof.

[0238] As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

[0239] As used herein, when a numerical value is preceded by the term "about", the term "about" is intended to indicate + / -10%.

[0240] Although various features of the disclosure may be described in the context of a single embodiment, the features may also be provided separately or in any suitable combination. Conversely, although the disclosure may be described herein in the context of separate embodiments for clarity, the disclosure may also be implemented in a single embodiment. Furthermore, it should be understood that the disclosure can be carried out or practiced in various ways, and that the disclosure can be implemented in embodiments other than the exemplary ones described herein below. The descriptions, examples and materials presented in the description, as well as in the claims, should not be construed as limiting, but rather as illustrative. Terms for indicating relative direction or location, such as "right" and "left", "up" and "down", "top" and "bottom", “horizontal” and "vertical", "higher" and "lower", and the like, may also be used, without limitation.

[0241] As used herein, a phrase in the form “A and / or B” means a selection from the group consisting of (A), (B) or (A and B). As used herein, a phrase in the form “at least one of A, B and C” means a selection from the group consisting of (A), (B), (C), (A and B), (A and C), (B and C) or (A and B and C).

[0242] Embodiments of methods and / or devices described herein may involve performing or completing selected tasks manually, automatically, or a combination thereof. Some methods and / or devices described herein are implemented with the use of components that comprise hardware, software, firmware or combinations thereof. In some embodiments, some components are general-purpose components such as general purpose computers or digital processors. In some embodiments, some components are dedicated or custom components such as circuits, integrated circuits or software.

[0243] For example, in some embodiments, some of an embodiment is implemented as a plurality of software instructions executed by a data processor, for example which is part of a general-purpose or custom computer. In some embodiments, the data processor or computer comprises volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. In some embodiments, implementation includes a network connection. In some embodiments, implementation includes a user interface, generally comprising one or more of input devices (e.g., allowing input of commands and / or parameters) and output devices (e.g., allowing reporting parameters of operation and results.

[0244] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0245] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the scope of the appended claims.

[0246] Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention.

[0247] Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims

CLAIMS:

1. A patch device for reducing the incidence of infections associated with the insertion site of a transdermal medical device comprising: a patch body having a perimeter, said patch body comprising a multilayer sheet, said multilayer sheet having at least two layers; an electrically-conductive biocompatible layer having a perimeter, a thickness, an upper surface and a lower contact surface; and a dielectric electrode-bearing layer having a perimeter, a thickness, an upper surface and a lower surface, wherein to said lower surface of said electrodebearing layer are attached at least two electrodes of a conductive material, wherein said lower surface of said electrode-bearing layer intimately contacts said upper surface of said biocompatible layer so that said electrodes are disposed between said biocompatible layer and said electrode-bearing layer, the patch device further comprising an electrical connector in electrical communication with said electrodes.

2. The patch device of claim 1, configured to receive an antiseptic current from a driving unit through said electrical connector, said antiseptic current characterized by: having a pulsed DC waveform with a frequency of not more frequent than about 0.1 Hz and not less frequent than about 10 Hz; having a potential of not less than about 0.1 V and not greater than about 10 V; and having an intensity of not less than about 1 microampere and not more than about 2 milliampere.

3. The patch device of any one of claims 1 to 2, wherein said patch body is conformable4. The patch device of any one of claims 1 to 3, said patch body including a slit extending from a perimeter of said patch body to a slit-terminus located at an inner portion of said patch body, said slit having two edges, said slit allowing passing the shaft of a transdermal medical device from said perimeter of said patch body to said slit terminus while the transdermal medical device is deployed in the body of a living animal.

5. The patch device of claim 4, said slit terminus being a through-hole through said biocompatible layer and said electrode-bearing layer that has dimensions to encircle the shaft of a transdermal medical device having a specific size.

6. The patch device of any one of claims 1 to 5, said patch body including a through- hole passing from said upper surface of said patch body, through said electrode-bearing layer and through said biocompatible layer, said through-hole configured to accommodate the shaft of a transdermal medical device having a specific size, wherein said through-hole is not associated with a slit in said patch body.

7. The patch device of any one of claims 1 to 3, said patch body being a sheet without a through-hole configured to accommodate the shaft of a transdermal medical device and without a slit allowing passing the shaft of a transdermal medical device from the perimeter of said patch body to a slit terminus.

8. The patch device of claim 7, said patch body configured to allow: cutting said patch body to make a slit allowing passing the shaft of a transdermal medical device from said perimeter of said patch body to a slit terminus while the transdermal medical device is deployed in the body of a living animal; and / or perforating said patch body to make a through-hole passing from said upper surface of said patch body, through said electrode-bearing layer and through said biocompatible layer, said through-hole configured to accommodate the shaft of a transdermal medical device.

9. The patch device of any one of claims 1 to 8, wherein the thickness of said biocompatible layer is not less than about 10 micrometers and not more than about 3 mm.

10. The patch device of any one of claims 1 to 9, wherein said electrode-bearing layer is an outer cover layer of said patch body.

11. The patch device of any one of claims 1 to 9, said patch body further comprising an additional outer cover layer different from said electrode-bearing layer, said outer cover layer having a perimeter, a thickness, an upper surface and a lower surface, said lower surface of said outer cover layer facing said upper surface of said electrode-bearing layer.

12. The patch device of any one of claims 10 to 11, wherein said perimeter of said outer cover layer is larger than said perimeter of said biocompatible-layer so that when the patch device is in use and said biocompatible layer is contacting a skin surface, portions of said outer cover layer extend outwards beyond the perimeter of said biocompatible layer and overhang said biocompatible layer so that the lower surface of the overhanging portions of said outer cover layer contact the skin during use of the patch device.

13. The patch device of any one of claims 1 to 12, further comprising a dislodgement sensor to identify if said patch body has been dislodged after being placed on a skin surface.

14. The patch device of claim 13, wherein said perimeter of said outer cover layer is larger than said perimeter of said biocompatible-layer so that when the patch device is in use and said biocompatible layer is contacting a skin surface, portions of said outer cover layer extend outwards beyond the perimeter of said biocompatible layer and overhang said biocompatible layer so that a lower surface of said overhanging portions of said outer cover layer contact the skin during use of the patch device, wherein said lower surface of said overhanging portions bear electrodes of said dislodgement sensor.

15. The patch device of any one of claims 1 to 14, further comprising a conductive element, said conductive element configured to be attached to the shaft of a transdermal medical device and also configured to receive an antiseptic current from an electrical power source.

16. A method for reducing the incidence of infections associated with the insertion site of a transdermal device, the method comprising: i. deploying a transdermal medical device in the body of a living animal so that a shaft of said transdermal medical device penetrates into a skin opening through a transdermal passage so that a distal end of said shaft is located inside the body and a proximal end of said shaft is located outside of the body; ii. placing a patch body of a patch device according to any one of claims 1 to 15 with a perimeter of said patch body in proximity of the location of said skin opening and so that a lower contact surface of a biocompatible layer of said patch body makesintimate contact with a skin surface of the living animal; iii. subsequently to both 'i' and 'ii', activating a driving unit that is functionally- associated with electrodes of said patch body through an electrical connector of said patch device to provide an antiseptic electrical current to said electrodes, thereby producing an antiseptic signal in said biocompatible layer that has an antiseptic effect at the interface between said skin surface and a contact surface of said biocompatible layer, said antiseptic signal thereby decreasing development of a biofilm and / or pathogens on said skin surface and in proximity of said perimeter of said patch body.

17. The method of claim 16, wherein said animal is a non-human animal.

18. The method of any one of claims 16 to 17, wherein said deploying said transdermal medical device 'i' is done prior to said placing said patch body 'ii'.

19. The method of any one of claims 16 to 17, wherein said deploying said transdermal medical device 'i' is done subsequent to said placing said patch body 'ii'.

20. The method of any one of claims 16 to 17, wherein said deploying said transdermal medical device 'i' and said placing said patch body 'ii' are done concurrently.

21. The method of any one of claims 15 to 20, said perimeter that is placed in proximity of the location of the skin opening is an outer perimeter of said patch body.

22. The method of any one of claims 15 to 20, said perimeter that is placed in proximity of the location of the skin opening is a perimeter of a through-hole or of a slit-terminus of said patch body.

23. The method of any one of claims 15 to 22, wherein no part of said shaft is in contact with said patch body.

24. The method of any one of claims 15 to 22, wherein at least part of said shaft is in contact with said patch body.

25. The method of any one of claims 15 to 22, wherein said patch body contactingly- encircles said shaft.

26. The method of any one of claims 15 to 25, further comprising placing a dislodgement sensor associated with said patch device to monitor that said patch body does not move27. The method of any one of claims 15 to 26, wherein a portion of an outer surface of said shaft that is located outside of the body of the animal is electrically-conductive and the method further comprises: placing said electrically-conductive portion of said outer surface of said shaft in an electrical circuit configured to carry an antiseptic electrical current;and providing an antiseptic electrical current to said electrically-conductive portion through said circuit to produce an antiseptic signal at said electrically-conductive portion of said outer surface of said shaft.

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