Wound healing system and method

Abstract

Disclosed herein are wound healing systems and methods thereof. The wound healing system may include a wound dressing, a catheter stabilization device, and an electrical stimulation device for applying electrical stimulation to at least heal or protect a wound associated with a percutaneous insertion site of a patient. The wound dressing may be configured as an electrode placed around the wound. The catheter stabilization device may include an anchor pad and a retainer coupled to the anchor pad. The anchor pad may be configured to adhere to the patient's skin near the insertion site. The retainer may be configured to stabilize the catheter assembly while the catheter tubing of the catheter assembly is arranged in the insertion site. The electrical stimulation device may include a power supply and an external circuit between the catheter stabilization device and the wound dressing for applying electrical stimulation.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 956,897, filed on January 3, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present application relates to the field of medical devices, and more specifically to wound healing systems and methods thereof. Background Art

[0004] Infectious microorganisms such as bacteria can invade the patient's body through the catheter tube arranged at the percutaneous insertion site, and subsequently cause infection (e.g., deep tissue infection, sepsis, etc.). Although such microorganisms can invade the patient's body through the inner cavity of the catheter tube, it is more likely that microorganisms colonized in the patient's skin near the insertion site will invade the patient's body. Therefore, clinicians usually inhibit microorganisms near the insertion site by applying antimicrobial agents (such as alcohol-based chlorhexidine or iodine pyruvate solutions) before catheter insertion. However, during catheter insertion, microorganisms quickly grow back near the insertion site, thereby requiring frequent dressing changes in order to reapply antimicrobial agents and reduce the risk of infection. This leaves enough room for clinician errors in aspects such as unintentional forgetting of dressing changes, forgetting during dressing changes, or improper application of antimicrobial agents.

[0005] Disclosed herein are wound healing systems and methods that address at least the aforementioned problems. Summary of the invention

[0006] Disclosed herein is a wound healing system, which in some embodiments includes a wound dressing, a catheter stabilization device, and an electrical stimulation device for applying electrical stimulation to heal or protect at least a wound associated with a percutaneous insertion site of a patient. The wound dressing is configured as an electrode placed around the wound. The catheter stabilization device includes an anchor pad and a retainer connected to the anchor pad. The anchor pad is configured to adhere to the patient's skin near the insertion site. The retainer is configured to stabilize the catheter assembly while the catheter tubing of the catheter assembly is arranged in the insertion site. The electrical stimulation device includes a power supply for applying electrical stimulation and an external circuit between the catheter stabilization device and the wound dressing.

[0007] In some embodiments, the wound healing system further comprises an adhesive bandage for placement over the combination of the wound dressing, the catheter stabilization device, and the catheter assembly. The adhesive bandage is configured to adhere the combination of the wound dressing, the catheter stabilization device, and the catheter assembly to the patient for further stabilization.

[0008] In some embodiments, the wound dressing includes an electrical conductor.The body of the wound dressing includes a matrix of a naturally occurring polymer, a synthetic polymer, or a composite thereof, the matrix having dispersed therein a metal, a salt, a conductive polymer, or a conductive allotrope of carbon.

[0009] In some embodiments, the body of the wound dressing includes a conductive hydrogel.

[0010] In some embodiments, a wound dressing includes a body. The body of the wound dressing includes a matrix of a naturally occurring polymer, a synthetic polymer, or a composite thereof, the matrix being configured to become electrically conductive when at least partially saturated with a body fluid.

[0011] In some embodiments, the wound dressing includes an antimicrobial agent.

[0012] In some embodiments, the external circuit includes a pair of electrical leads extending from the catheter stabilization device for connection to the wound dressing. The electrical leads are composed of coated metal wires, conductive coatings, or a combination thereof.

[0013] In some embodiments, the electrical stimulation device includes an integrated circuit disposed in the body of the retainer or in a wing or cover of the retainer for locking a portion of the catheter assembly in the retainer. The integrated circuit includes at least a power circuit coupled to an external circuit configured to transmit electrical energy from a power source to the wound dressing, and a control circuit configured to modulate the manner in which the electrical energy is delivered to the wound dressing.

[0014] In some embodiments, the integrated circuit is configured to modulate the electrical energy so that a low intensity current between about 200 and 1000 mA is delivered to the wound dressing continuously for more than 1 s at a time. The current has a specific polarity.

[0015] In some embodiments, the integrated circuit is configured to modulate the electrical energy so that a high voltage current between about 50 and 150 V is delivered to the wound dressing in 1-ms pulses. The current has an alternating polarity or a specific polarity.

[0016] In some embodiments, the integrated circuit includes biofeedback logic configured to detect impedance changes through the patient's skin or the wound dressing. The biofeedback logic is further configured to modulate the manner in which electrical energy is delivered to the wound dressing based on the impedance changes.

[0017] In some embodiments, the power source is a battery. The battery is rechargeable or replaceable.

[0018] In some embodiments, the battery is rechargeable. The retainer includes a port for charging the rechargeable battery.

[0019] In some embodiments, the retainer includes one or more light emitting diodes ("LEDs") configured to indicate when the electrical stimulation device is activated.

[0020] In some embodiments, the wound healing system further includes a controller configured to be communicatively coupled to the catheter stabilization device and to allow a user thereof to modulate the manner in which electrical energy is delivered to the wound dressing.

[0021] A wound healing system is also disclosed herein, which in some embodiments includes a wound dressing, a catheter stabilization device, an electrical stimulation device and an adhesive bandage, the electrical stimulation device being used to apply electrical stimulation to heal or protect at least a wound associated with a percutaneous insertion site of a patient. The wound dressing is configured as an electrode placed around the wound. The catheter stabilization device includes an anchor pad and a retainer connected to the anchor pad. The anchor pad is configured to adhere to the skin of the patient near the insertion site. The retainer is configured to stabilize the catheter assembly while the catheter tubing of the catheter assembly is arranged in the insertion site. The electrical stimulation device includes a power supply, an external circuit and an integrated circuit, the external circuit is between the catheter stabilization device and the wound dressing, and the integrated circuit is arranged in the body of the retainer or the wing or cover of the retainer for locking a portion of the catheter assembly in the retainer. The external circuit includes a pair of electrical leads extending from the catheter stabilization device for connecting to the wound dressing and applying electrical stimulation. The integrated circuit includes at least a power supply circuit and a control circuit. The power supply circuit is connected to the external circuit and is configured to transmit electrical energy from the power supply to the wound dressing. The control circuit is configured to modulate the manner in which electrical energy is delivered to the wound dressing. The adhesive bandage is configured to be placed over the combination of the wound dressing, the catheter stabilizing device, and the catheter assembly to adhere the combination to the patient for further stabilizing the combination.

[0022] Also disclosed herein is a method of a wound healing system, which in some embodiments includes a wound dressing application step: applying a wound dressing around a wound associated with a percutaneous insertion site of a patient. The wound dressing is configured as an electrode. The method also includes an adhesion step: adhering an anchor pad of a catheter stabilization device to the skin of the patient near the insertion site. The method also includes a stabilization step: stabilizing the catheter assembly in a retainer of the catheter stabilization device. The retainer is connected to the anchor pad. The method also includes an electrical stimulation application step: applying electrical stimulation using an electrical stimulation device to heal or protect the wound. The electrical stimulation device includes a power supply and an external circuit, which is located between the catheter stabilization device and the wound dressing for applying electrical stimulation.

[0023] In some embodiments, the method further comprises the step of inserting a catheter tube of the catheter assembly into the insertion site prior to stabilizing the catheter assembly in the retainer of the catheter stabilizing device.

[0024] In some embodiments, the method further comprises the step of placing an adhesive bandage over the combination of the wound dressing, catheter stabilization device, and catheter assembly to adhere the combination to the patient for further stabilization.

[0025] In some embodiments, the method further comprises an electrical lead connecting step of connecting a pair of electrical leads from the catheter stabilization device to the wound dressing to form an external circuit for applying electrical stimulation.

[0026] In some embodiments, the electrical lead attaching step includes spraying the electrical leads on the catheter assembly with a conductive paint.

[0027] In some embodiments, the method further comprises a charging cable connection step: connecting a charging cable to a port of the retainer. The charging cable connection step comprises charging a rechargeable battery, the rechargeable battery being a power source.

[0028] In some embodiments, the method further comprises the step of determining whether the electrical stimulation device is activated by observing one or more LEDs of the retainer indicating activation of the electrical stimulation.

[0029] In some embodiments, the method further comprises the step of modulating the manner in which the electrical energy is delivered to the wound dressing by controlling a controller communicatively coupled to the catheter stabilization device.

[0030] These and other features of the concepts presented herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A wound healing system according to some embodiments is shown.

[0032] Figure 2 A wound healing system with a first catheter stabilization device in use on a patient is shown according to some embodiments.

[0033] Figure 3 A wound healing system with a second catheter stabilization device is shown in use on a patient, according to some embodiments. DETAILED DESCRIPTION

[0034] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are easily separated from the specific embodiments, and may be optionally combined or substituted with the features of any one of the many other embodiments disclosed herein.

[0035] About the terms used herein, it should also be understood that these terms are to describe some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and sequence numbers or numerical restrictions are not provided. For example, "first", "second" and "third" features or steps do not need to appear in this order, and the specific embodiments including such features or steps do not need to be limited to these three features or steps. Markings such as "left", "right", "top", "bottom", "front", "back" are used for convenience and are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such markings are used to reflect, for example, relative position, orientation or direction. Singular forms of "a kind of", "one" and "the" include plural forms, unless the context clearly defines otherwise.

[0036] With respect to "proximal," "proximal portion," or "proximal end portion," for example, the catheters disclosed herein include the portion of the catheter that is intended to be close to a clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be close to a clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes an end of the catheter that is intended to be close to a clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal portion, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0037] With respect to "distal," "distal portion," or "distal end portion," for example, a catheter disclosed herein includes a portion of the catheter that is intended to be near or in a patient when the catheter is used on a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or in a patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes an end of the catheter that is intended to be near or in a patient when the catheter is used on a patient. A distal portion, distal portion, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context indicates otherwise, a distal portion, distal portion, or distal length of a catheter is not an end portion or end length of a catheter.

[0038] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0039] Similarly, infectious microorganisms such as bacteria can invade the patient's body through the catheter tubing arranged at the percutaneous insertion site, and subsequently cause infection (e.g., deep tissue infection, sepsis, etc.). Although such microorganisms can invade the patient's body through the lumen of the catheter tubing, it is more likely that the microorganisms colonized in the skin of the patient near the insertion site will invade the patient's body. Therefore, clinicians usually suppress the microorganisms near the insertion site by applying antimicrobial agents (such as alcohol-based chlorhexidine or iodine pyruvate solutions) before catheterization. However, during catheterization, microorganisms grow rapidly again near the insertion site, thereby requiring frequent dressing changes to reapply antimicrobial agents and reduce infection risks. This leaves enough possibilities for clinician errors in aspects such as forgetting dressing changes unintentionally, forgetting or improperly applying antimicrobial agents during dressing changes.

[0040] Disclosed herein are wound healing systems and methods that address at least the aforementioned problems.

[0041] For example, a wound healing system includes, in some embodiments, a wound dressing, a catheter stabilization device, and an electrical stimulation device for applying electrical stimulation to at least heal or protect a wound associated with a percutaneous insertion site of a patient. The electrical stimulation is configured to inhibit the growth of microorganisms such as bacteria. Mechanistically, it can be considered that at least the growth of bacteria is inhibited by means of electrical stimulation to destroy the integrity of the bacterial membrane. Although inhibiting the growth of the aforementioned microorganisms contributes to wound healing, it can also be considered that electrical stimulation activates wound healing cells at the wound and promotes the migration of wound healing cells to the wound. In view of such a wound healing system, the risk of microbial infection such as bacteria is reduced with fewer auxiliary material changes to enhance wound healing.

[0042] Trauma healing system

[0043] Figure 1 A wound healing system 100 is shown according to some embodiments. Figure 2 and 3 A wound healing system 100 is shown in use on a patient according to some embodiments, each having a first catheter stabilizing device 110 and a second catheter stabilizing device 310. Figure 1-3 In each of the figures, a catheter assembly 140 is shown. Figure 1 An adhesive bandage 160 is shown in FIG. Figure 1Controller 150 is shown in the figure, but each of the wound healing system components in the catheter assembly 140, adhesive bandage 160, and controller 150 is an optional component of the wound healing system 100, because each of the aforementioned components can be provided separately for the wound healing system 100. That is, any one or more of the catheter assembly 140, adhesive bandage 160, and controller 150 can be provided together with the main components of the wound healing system 100 described below (for example, in a kit).

[0044] The major components of the wound healing system 100 include, but are not limited to, a wound dressing 130, a catheter stabilization device 110 or 310, and an electrical stimulation device for applying electrical stimulation to at least heal or protect a percutaneous insertion site (e.g., Figure 2 and 3 The wound associated with the insertion site IS of the wound healing system 100. Each of the aforementioned major components of the wound healing system 100 will be described in turn below. However, with respect to the electrical stimulation device, the electrical stimulation device also includes the electrical stimulation-related features of the wound dressing 130 and the catheter stabilization device 110 or 310. Although some of the electrical stimulation-related features of the wound dressing 130 and the catheter stabilization device 110 or 310 are explicitly described below as part of the electrical stimulation device, it should be understood that any features of the wound dressing 130 or the catheter stabilization device 110 or 310 that support providing electrical stimulation of the wound healing system 100 can be included as part of the electrical stimulation device.

[0045] Wound dressing 130 is configured as an electrode for placement on and around a wound associated with an insertion site IS of a patient. Wound dressing 130 includes a body 232 having a slot 134 therein, slot 134 configured to accommodate catheter tubing 142 of catheter assembly 140 while catheter tubing 142 is disposed in the insertion site IS of the patient and wound dressing 130 is on and around a wound associated with insertion site IS.

[0046] The body 232 of the wound dressing 130 is conductive or configured to become conductive under certain conditions. The body 232 of the wound dressing 130 includes a matrix of naturally occurring polymers (e.g., cotton [i.e., cellulose]), synthetic polymers (e.g., hydrogels, polyurethanes, etc.), or combinations thereof.

[0047] When the body 232 of the wound dressing 130 is conductive, its matrix includes a metal (eg, copper, silver, etc.), a salt, a conductive polymer, or a conductive allotrope of carbon dispersed therein. For example, the body 232 of the wound dressing 130 may be a conductive hydrogel.

[0048] When the body 232 of the wound dressing 130 is configured to become conductive, the body 232 becomes conductive when the body 232 is at least partially saturated with body fluids (such as sweat, exudate, blood, etc.), which include, for example, conductive ions. Even when the body 232 of the wound dressing 130 is already conductive, the aforementioned body fluids can enhance the conductivity.

[0049] The body 232 of the wound dressing 130 may include an antimicrobial agent dispersed therethrough, wherein the antimicrobial agent is configured to act synergistically with the electrical stimulation to inhibit the growth of bacteria. The antimicrobial agent may include, but is not limited to, chlorhexidine, silver, or copper. Alternatively or additionally, the body 232 of the wound dressing 130 may include nitric acid, which is reduced to nitric oxide in the body 232 of the wound dressing 130 during electrical stimulation of the wound. The nitric oxide is then released from the body 232 of the wound dressing 130 as an antimicrobial agent.

[0050] The catheter stabilization device 110 or 310 includes an anchor pad 212 and a retainer 214 or 314 coupled to the anchor pad 212 .

[0051] The anchor pad 212 is configured to adhere to the patient's skin near the insertion site IS, such as Figure 2 and 3 The anchor pad 212 may be formed of a breathable, non-absorbent tricot polyester or closed cell foam with a hypoallergenic adhesive on the patient-facing side of the anchor pad 212. The retainer 214 or 314 is adhered to the side of the anchor pad 212 opposite the patient-facing side of the anchor pad 212.

[0052] The retainer 214 or 314 is configured to stabilize the catheter assembly 140 (eg, a peripherally inserted central catheter ["PICC"]) while the catheter tube 142 of the catheter assembly 140 is disposed at the insertion site IS, such as Figure 2 and 3 As shown. The retainer 214 or 314 may include a suture-wing compartment within the body of the retainer 214 or 314, which is configured to receive the suture wing 246 of the catheter assembly 140 therein. The suture wing compartment may include a post (e.g., post 216) extending from the bottom of the suture wing compartment, which is configured to be inserted into the suture hole (e.g., suture hole 244) of the suture wing 246 of the catheter assembly 140. The retainer 214 or 314 may be formed or molded from polyurethane.

[0053] The retainer 214 is different from the retainer 314 because the retainer 214 includes a hinged wing 218 coupled to the body of the retainer 214. The hinged wing 218 is configured to open outwardly for inserting the suture wing 246 of the catheter assembly 140 into the suture wing compartment of the retainer 214. The hinged wing 218 is also configured to close inwardly and snap together with the body of the retainer 214 for locking the suture wing 246 of the catheter assembly 140 in the suture wing compartment of the retainer 214. The hinged wing 218 includes a tab, and the body of the retainer 214 includes a groove so that the hinged wing 218 can snap together with the body of the retainer 214.

[0054] The retainer 314 is different from the retainer 214 because the retainer 314 includes a cover 318 that is removably or fixedly coupled to the body of the retainer 314. When removably coupled, the cover 318 is configured to snap together with the body of the retainer 314 for locking the suture wings 246 of the catheter assembly 140 therein after the suture wings 246 are inserted into the suture wing compartment of the retainer 314. Like the retainer 214 and its hinged wings 218, the cover 318 includes a tab and the body of the retainer 314 includes a groove so that the cover 318 can snap together with the body of the retainer 314. When fixedly coupled, the cover 318 includes a hinged minor-end portion so that the non-hinged minor-end portion can be lifted away from the body of the retainer 314 for inserting the suture wings 246 of the catheter assembly 140 into the suture wing compartment of the retainer 314. The unhinged smaller end portion of the cover 318 includes a tongue, and a corresponding portion of the body of the retainer 314 includes a groove, so that the cover 318 can be snapped together with the body of the retainer 314 to lock the suture wing 246 of the catheter assembly 140 therein after the suture wing 246 is inserted into the suture wing chamber of the retainer 314.

[0055] The electrical stimulation device includes a power source and an external circuit, which is connected between the catheter stabilization device 110 or 310 and the wound dressing 130 (such as Figure 2 and 3 ), for applying electrical stimulation.

[0056] Although not shown, the power source is a battery (e.g., a micro battery), which may be a replaceable battery or a rechargeable battery. The battery may be arranged in a battery compartment in the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, in the wing of the hinged wing 218 of the retainer 214, or in the cover 318 of the retainer 314. The battery compartment may be configured to cooperate with a sliding locking cover on the battery compartment for entering the battery compartment when the replaceable battery needs to be replaced. Optionally, the battery compartment may be inaccessibly sealed with the rechargeable battery therein to ensure a trouble-free operating state of the catheter stabilization device 110 or 310. The retainer 214 or 314 may include a charging port 222 electrically connected to the rechargeable battery for charging the rechargeable battery as needed.

[0057] The external circuit includes a pair of electrical leads 120 extending from the catheter stabilization device 110 or 310, or electrical contacts electrically connected to a power source (e.g., electrical contacts of a post) for connection with the wound dressing 130. Although the electrical leads 120 shown are composed of coated metal wires, the electrical leads 120 may alternatively be composed of a conductive paint, which is optionally combined with the coated metal wires. The conductive paint can be sprayed along the catheter tube 142 from the power source or the electrical contacts of the catheter stabilization device 110 or 310 electrically connected thereto to a distance of less than or equal to about 3 cm from the proximal end of the catheter tube 142, so that the conductive paint contacts the wound dressing 130.

[0058] The electrical stimulation device may also include an integrated circuit disposed in the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, in the wing of the hinged wing 218 of the retainer 214, or in the cover 318 of the retainer 314. The integrated circuit includes at least a power circuit and a control circuit. While the wound healing system 100 is in use, the power circuit is connected to an external circuit. The power circuit is configured to transmit electrical energy from a power source to the wound dressing 130 with the aid of an external circuit. The control circuit is configured to modulate the manner in which the electrical energy is delivered to the wound dressing 130 through the power circuit and the external circuit.

[0059] The integrated circuit can be configured to modulate electrical energy in a variety of different ways. For example, the integrated circuit can be configured to modulate electrical energy so that a low-intensity current between about 200 and about 1000 mA is continuously delivered to the wound dressing 130, each time for more than 1 second. Such a current can have a specific polarity. It can be considered that the application of such a low-intensity current activates wound healing cells at the wound and promotes the migration of wound healing cells to the wound. The integrated circuit can be configured to modulate electrical energy so that a high-voltage current between about 50 and 150 V is delivered to the wound dressing 130 in a 1-ms pulse or less than a 1 ms pulse. Such a current can have an alternating polarity or a specific polarity. It can be considered that the application of such a high-voltage current inhibits the growth of bacteria by destroying the integrity of the bacterial membrane with the aid of electrical stimulation.

[0060] The integrated circuit may include biofeedback logic configured to detect impedance changes through the patient's skin or the wound dressing 130. The biofeedback logic may also be configured to modulate the manner in which electrical energy is delivered to the wound dressing 130 based on the impedance changes. In addition to modulating the manner in which electrical energy is delivered to the wound dressing 130, the biofeedback logic may be configured to detect excessive bleeding via impedance changes.

[0061] Although not necessarily part of the electrical stimulation device, the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, the wing of the hinged wing 218 of the retainer 214, or the cover 318 of the retainer 314 may include one or more LEDs 224 that are configured to indicate when the electrical stimulation device is activated, the mode of use of the electrical stimulation device, when the battery needs to be charged or replaced, etc.

[0062] The wound healing system 100 may also include a controller 150, which represents a bedside controller, a handheld controller, or even a smart phone with a communication module configured to communicate with the patient via Wi-Fi, etc. communicates with the communication module in the retainer 214 or 314 of the catheter stabilization device 110 or 310. The controller 150 is configured to allow its user to modulate the manner in which electrical energy is delivered to the wound dressing 130. For example, the controller 150 may be configured to freely allow the user to adjust the frequency, duration, voltage, or polarity of the electrical energy delivered to the wound dressing 130, which is useful for inhibiting bacterial growth or optimizing one or more stages of wound healing. Alternatively or additionally, the controller 150 may be configured with one or more programs, settings, or modes to automatically adjust the frequency, duration, voltage, or polarity of the electrical energy delivered to the wound dressing 130.

[0063] The wound healing system 100 may further include an adhesive bandage 160 for placement on the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140. The adhesive bandage 160 includes a patient-facing side having a hypoallergenic adhesive configured to adhere the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140 to the patient for further stabilization. The adhesive bandage 160 may include a transparent window having a reinforced edge of non-absorbent warp-knitted polyester so that the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140 can be viewed through the transparent window for monitoring the wound healing system 100. It is noteworthy that if the electrical leads 120 of the external circuit of the electrical stimulation device are composed of a conductive coating, the adhesive bandage 160 can protect the electrical leads 120 from wear by limiting the exposure of the electrical leads 120.

[0064] method

[0065] The method of wound healing system 100 includes at least a method of using wound healing system 100. If the catheter assembly 140 is provided with the wound healing system 100, using the wound healing system 100 may include the step of inserting the catheter tube 142 of the catheter assembly 140 into a percutaneous insertion site (e.g., Figure 2 and 3 The method may further include a stabilizing step of stabilizing the catheter assembly 140 in the retainer 214 or 314 of the catheter stabilizing device 110 or 310 while the catheter tube 142 of the catheter assembly 140 is disposed in the insertion site IS.

[0066] The method of using the wound healing system 100 generally includes a wound dressing application step of applying a wound dressing 130 around a wound associated with the insertion site IS. The method also includes an adhering step of adhering the anchor pad 212 of the catheter stabilization device 110 or 310 to the skin of the patient near the insertion site IS. The method also includes an electrical lead connection step of connecting the electrical lead 120 from the catheter stabilization device 110 or 310 to the wound dressing 130 to form an external circuit for applying electrical stimulation. The electrical lead connection step may include spraying the electrical lead 120 on the catheter assembly 140 using a conductive paint. The method also includes an electrical stimulation application step of applying electrical stimulation thereto using an electrical stimulation device to heal the wound.

[0067] The method may further include the step of determining whether the electrical stimulation device is activated by observing one or more LEDs 224 of the retainer 214 or 314 indicating that electrical stimulation is activated.

[0068] The method may further include a modulation step of modulating the manner in which electrical energy is delivered to the wound dressing 130 by controlling the controller 150 while the controller 150 is communicatively coupled to the catheter stabilization device 110 or 310 .

[0069] The method may further include another step of determining whether the rechargeable battery needs to be charged. If so, the method may further include a charging cable connection step of connecting a charging cable to the charging port 222 of the retainer 214 or 314 of the catheter stabilizing device 110 or 310. The charging cable connection step may include charging the rechargeable battery.

[0070] The method may further include the step of placing an adhesive bandage 160 over the combination of the wound dressing 130, catheter stabilization device 110 or 310, and catheter assembly 140 to adhere the combination to the patient for further stabilization.

[0071] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may occur to those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, without departing from the scope of the concepts provided herein, deviations may be made from the specific embodiments disclosed herein.

Claims

1. A wound healing system, comprising: a wound dressing configured as an electrode for placement about a wound associated with a percutaneous insertion site on a patient; A catheter stabilization device, the catheter stabilization device comprising: an anchor pad configured to adhere to the patient's skin proximate the insertion site, and a retainer coupled to the anchor pad, the retainer configured to stabilize the catheter assembly while a catheter tube of the catheter assembly is disposed in the insertion site; and An electrical stimulation device for applying electrical stimulation to heal or protect the wound, the electrical stimulation device comprising: Power supply, and An external circuit, between the catheter stabilization device and the wound dressing, is used to apply the electrical stimulation.

2. The wound healing system of claim 1 further comprising an adhesive bandage configured to be placed over the combination of the wound dressing, the catheter stabilization device, and the catheter assembly to adhere the combination to the patient for further stabilization.

3. A wound healing system according to claim 1 or 2, wherein the wound dressing comprises a conductive body, the body comprising a matrix of a naturally occurring polymer, a synthetic polymer or a composite thereof, the matrix having conductive allotropes of metals, salts, conductive polymers or carbon dispersed therein.

4. The wound healing system of claim 3, wherein the body of the wound dressing comprises a conductive hydrogel.

5. A wound healing system according to claim 1 or 2, wherein the wound dressing comprises a body comprising a matrix of a naturally occurring polymer, a synthetic polymer or a composite thereof, the matrix being configured to become conductive when at least partially saturated with body fluids.

6. The wound healing system of claim 3, wherein the wound dressing comprises an antimicrobial agent.

7. A wound healing system according to claim 1, wherein the external circuit includes a pair of electrical leads, which extend from the catheter stabilization device for connecting to the wound dressing, and the electrical leads are composed of coated metal wires, conductive coatings or a combination thereof.

8. The wound healing system according to claim 1, wherein the electrical stimulation device comprises an integrated circuit, which is arranged in the body of the retainer or the wing or cover of the retainer for locking a portion of the catheter assembly in the retainer, and the integrated circuit comprises at least: a power circuit coupled to the external circuit and configured to transfer electrical energy from the power source to the wound dressing; and a control circuit configured to modulate the manner in which the electrical energy is delivered to the wound dressing.

9. The wound healing system of claim 8, wherein the integrated circuit is configured to modulate the electrical energy so that a low-intensity current between 200 and 1000 mA with a specific polarity is continuously delivered to the wound dressing, each time lasting more than 1 s.

10. The wound healing system according to claim 8, wherein the integrated circuit is configured to modulate the electrical energy so that a high voltage current between 50 and 150 V with alternating polarity or specific polarity is delivered to the wound dressing in 1 ms pulses.

11. A wound healing system according to any one of claims 8 to 10, wherein the integrated circuit includes biofeedback logic, which is configured to detect impedance changes through the patient's skin or the wound dressing and modulate the manner in which the electrical energy is delivered to the wound dressing.

12. The wound healing system of claim 1, wherein the power source is a battery, and the battery is rechargeable or replaceable.

13. The wound healing system of claim 12, wherein the battery is rechargeable and the retainer includes a port for charging the rechargeable battery.

14. The wound healing system of claim 1, wherein the retainer comprises one or more light emitting diodes configured to indicate when the electrical stimulation device is activated.

15. The wound healing system of claim 1, further comprising a controller configured to be communicatively coupled to the catheter stabilizing device and to allow a user thereof to modulate the manner in which electrical energy is delivered to the wound dressing.

16. A wound healing system, comprising: a wound dressing configured as an electrode for placement about a wound associated with a percutaneous insertion site on a patient; A catheter stabilization device, the catheter stabilization device comprising: an anchor pad configured to adhere to the patient's skin proximate the insertion site, and a retainer coupled to the anchor pad, the retainer configured to stabilize the catheter assembly while a catheter tube of the catheter assembly is disposed in the insertion site; An electrical stimulation device for applying electrical stimulation to heal or protect the wound, the electrical stimulation device comprising: power supply, an external circuit between the catheter stabilization device and the wound dressing for applying the electrical stimulation, the external circuit comprising a pair of electrical leads extending from the catheter stabilization device for connection to the wound dressing, and an integrated circuit disposed in the body of the retainer or in a wing or cover of the retainer for locking a portion of the catheter assembly in the retainer, the integrated circuit comprising at least: a power circuit coupled to the external circuit configured to transmit electrical energy from the power source to the wound dressing; and a control circuit configured to modulate the manner in which the electrical energy is delivered to the wound dressing; and An adhesive bandage configured for placement over the combination of the wound dressing, the catheter stabilization device, and the catheter assembly to adhere the combination to the patient for further stabilization.

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