Wound healing system and method

Abstract

Disclosed herein are wound healing systems and methods. The wound healing system may include a wound dressing, a catheter stabilization device, and electrical stimulation means for applying electrical stimulation to heal or protect a wound associated with at least a percutaneous insertion site on a patient. The wound dressing may be configured as an electrode for placement 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 adjacent the insertion site. The retainer may be configured to stabilize the catheter assembly while the catheter tube of the catheter assembly is positioned at the insertion site. The electrical stimulation means may include a power source and external circuitry between the catheter stabilization device and the wound dressing for applying the electrical stimulation.

Description

[Background technology]

[0001] Infectious microorganisms such as bacteria can enter the body through the catheter tube placed at the percutaneous insertion site and cause infections (deep tissue infections, sepsis, etc.). Although such microorganisms can enter the patient's body through the lumen of the catheter tube, they are more likely to enter the patient's body through microorganisms that have colonized the patient's skin near the insertion site. Therefore, clinicians routinely suppress microorganisms around the insertion site by applying a disinfectant, such as an alcohol-based chlorhexidine or iodopovidone solution, before catheter insertion. However, because microorganisms grow rapidly at the catheter insertion site, frequent dressing changes are required to reapply the disinfectant and reduce the risk of infection. Therefore, there is ample opportunity for clinician error, such as unintentionally forgetting to change the dressing, forgetting to apply disinfectant during dressing change, or applying disinfectant inappropriately.

[0002] Disclosed herein is a wound healing system and method that addresses at least the above. Summary of the Invention

[0003] A wound healing system is disclosed herein, and in some embodiments, the wound healing system includes a wound dressing, a catheter stabilization device, and electrical stimulation means 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 for placement around a wound. The catheter stabilization device includes an anchor pad and a retainer coupled 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 tube of the catheter assembly is placed at the insertion site. The electrical stimulation means includes a power source and an external circuit between the catheter stabilization device and the wound dressing for applying electrical stimulation.

[0004] In some embodiments, the wound healing system further comprises a bandage for placement over the combination of the wound dressing, the catheter stabilizing device, and the catheter assembly, the bandage configured to adhere the combination of the wound dressing, the catheter stabilizing device, and the catheter assembly to the patient for stabilization.

[0005] In some embodiments, the wound dressing comprises a conductive body, the body of the wound dressing comprising a matrix of a naturally occurring polymer, a synthetic polymer, or a composite thereof, in which a metal, a salt, a conductive polymer, or a conductive allotrope of carbon is dispersed.

[0006] In some embodiments, the body of the wound dressing comprises a conductive hydrogel. In some embodiments, the wound dressing comprises a body, the body of the wound dressing comprising a matrix of a naturally occurring polymer, a synthetic polymer, or a composite thereof, the matrix configured to be electrically conductive when at least partially saturated with bodily fluid.

[0007] In some embodiments, the wound dressing comprises an antimicrobial agent. 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 being constructed of coated metal wiring, conductive paint, or a combination thereof.

[0008] In some embodiments, the electrical stimulation means comprises an integrated circuit disposed on a body of the retainer or on a wing or cover of the retainer for locking a portion of the catheter assembly to the retainer, the integrated circuit comprising at least a power supply circuit coupled to the external circuit configured to transfer power from a power source to a wound dressing, and a control circuit configured to regulate how the power is delivered to the wound dressing.

[0009] In some embodiments, the integrated circuit is configured to regulate power such that a low intensity current of between about 200 and 1000 mA is continuously delivered to the wound dressing for more than one second at a time, the current having a particular polarity.

[0010] In some embodiments, the integrated circuit is configured to regulate power such that a high voltage current of between about 50 and 150 V is delivered in 1 ms pulses to the wound dressing, the current having an alternating polarity or a specific polarity.

[0011] In some embodiments, the integrated circuit includes biofeedback logic configured to detect changes in impedance through the patient's skin or wound dressing, and the biofeedback logic configured to adjust how the power is delivered to the wound dressing in response to the changes in impedance.

[0012] In some embodiments, the power source is a battery, which is rechargeable or replaceable. In some embodiments, the battery is rechargeable, and the retainer includes a port for charging the rechargeable battery.

[0013] In some embodiments, the retainer includes one or more light emitting diodes (LEDs) configured to indicate when the electrical stimulation means is active. In some embodiments, the wound healing system further includes a controller configured to communicatively connect to the catheter stabilization device, the controller configured to allow a user to adjust how power is supplied to the wound dressing.

[0014] Also disclosed herein is a wound healing system, in some embodiments, the wound healing system includes a wound dressing, a catheter stabilization device, an electrical stimulation means for applying electrical stimulation to heal or protect at least a wound associated with a percutaneous insertion site of a patient, and a bandage. The wound dressing is configured as an electrode for placement around a wound. The catheter stabilization device includes an anchor pad and a retainer coupled 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 tube of the catheter assembly is placed at the insertion site. The electrical stimulation means includes a power source, an external circuit between the catheter stabilization device and the wound dressing, and an integrated circuit disposed in the body of the retainer or the wings or cover of the retainer for locking a portion of the catheter assembly to 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 the electrical stimulation. The integrated circuit includes at least a power circuit and a control circuit. The power circuit is coupled to the external circuit and configured to transfer power from the power source to the wound dressing. The control circuit is configured to regulate how the power is delivered to the wound dressing. The bandage is 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.

[0015] Also disclosed herein is a method of a wound healing system, which in some embodiments includes a wound dressing applying step of applying a wound dressing around a wound associated with a percutaneous insertion site on a patient, the wound dressing being configured as an electrode. The method also includes an adhering step of adhering an anchor pad of a catheter stabilization device to the skin of the patient proximate an insertion site. The method also includes a stabilizing step of stabilizing a catheter assembly within a retainer of the catheter stabilization device, the retainer being coupled to the anchor pad. The method also includes an electrical stimulation applying step of applying an electrical stimulation with an electrical stimulation means to heal or protect the wound. The electrical stimulation means includes a power source and an external circuit between the catheter stabilization device and the wound dressing for applying the electrical stimulation.

[0016] In some embodiments, the method further includes an insertion step of inserting a catheter tube of the catheter assembly into an insertion site prior to stabilizing the catheter assembly in a retainer of the catheter stabilization device.

[0017] In some embodiments, the method further includes a positioning step of placing a bandage 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.

[0018] In some embodiments, the method further comprises an electrical lead connection step of connecting a pair of electrical leads from the catheter stabilization device to the wound dressing to form an external circuit for applying the electrical stimulus.

[0019] In some embodiments, the electrical lead connecting step includes painting the electrical leads on the catheter assembly with a conductive paint. In some embodiments, the method further comprises a charging cable connecting step of connecting a charging cable to a port of the retainer, the charging cable connecting step comprising charging a rechargeable battery, the rechargeable battery being a power source.

[0020] In some embodiments, the method further comprises a determining step of determining that the electrical stimulation means is active by observing one or more LEDs on the retainer which indicate active electrical stimulation.

[0021] In some embodiments, the method further includes an adjusting step of adjusting how the power is supplied to the wound dressing by controlling a controller communicatively connected to the catheter stabilization device.

[0022] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0023] [Figure 1] 1 illustrates a wound healing system according to some embodiments. [Diagram 2] 1 illustrates a wound healing system including a first catheter stabilization device in use on a patient, according to some embodiments. [Diagram 3] 1 illustrates a wound healing system including a second catheter stabilization device in use on a patient, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Before some specific embodiments are disclosed 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 can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0025] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the 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 within a group of features or steps, and do not provide a sequential or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "front", "back", "top", "bottom", and other similar terms are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0026] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0027] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0028] 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. In addition, infectious microorganisms such as bacteria may enter the body through the catheter tube placed at the percutaneous insertion site, causing infections (deep tissue infections, sepsis, etc.). Although such microorganisms may enter the patient's body through the lumen of the catheter tube, they are more likely to enter the patient's body through microorganisms that have colonized the patient's skin near the insertion site. Therefore, clinicians routinely suppress microorganisms around the insertion site by applying a disinfectant, such as an alcohol-based chlorhexidine or iodopovidone solution, before catheter insertion. However, because microorganisms grow rapidly at the catheter insertion site, frequent dressing changes are required to reapply the disinfectant and reduce the risk of infection. Therefore, there is ample opportunity for clinician error, such as unintentionally forgetting to change the dressing, forgetting to apply disinfectant during dressing change, or applying disinfectant improperly.

[0029] Disclosed herein is a wound healing system and method that addresses at least the above. For example, a wound healing system, in some embodiments, includes a wound dressing, a catheter stabilization device, and an electrical stimulation means for applying electrical stimulation to heal or protect at least 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 is believed that the electrical stimulation inhibits at least bacterial growth in a manner that disrupts the integrity of bacterial membranes. While the inhibition of microbial growth as described above contributes to wound healing, it is believed that the electrical stimulation also activates wound healing cells at the wound site and promotes migration of wound healing cells thereto. Considering such a wound healing system, the risk of infection by microorganisms, such as bacteria, is reduced by reducing the need for dressing changes to enhance wound healing.

[0030] Wound Healing System FIG. 1 illustrates a wound healing system 100 according to some embodiments. FIG. 2 and FIG. 3 illustrate the wound healing system 100 with a first catheter stabilizing device 110 and a second catheter stabilizing device 310, respectively, in use on a patient according to some embodiments. Although a catheter assembly 140 is shown in each of FIG. 1-3, a bandage 160 is shown in FIG. 1, and a controller 150 is shown in FIG. 1, each of the wound healing system components of the catheter assembly 140, the bandage 160, and the controller 150 are optional components of the wound healing system 100 in the sense that each of the aforementioned components may be provided separately for use in the wound healing system 100. That is, any one or more of the catheter assembly 140, the bandage 160, and the controller 150 may be provided (e.g., in a kit) with the main components of the wound healing system 100 defined below.

[0031] The major components of the wound healing system 100 include, but are not limited to, the wound dressing 130, the catheter stabilization device 110 or 310, and electrical stimulation means for applying electrical stimulation to heal or protect at least a wound associated with a percutaneous insertion site of a patient, such as the insertion site IS of Figures 2 and 3. 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 means, the electrical stimulation means includes features of the wound dressing 130 and the catheter stabilization device 110 or 310 related to electrical stimulation. Some of the features of the wound dressing 130 and the catheter stabilization device 110 or 310 related to electrical stimulation will be set forth below as part of the electrical stimulation means, although it will be understood that any feature of the wound dressing 130 or the catheter stabilization device 110 or 310 that assists in providing the electrical stimulation of the wound healing system 100 may be included as part of the electrical stimulation means.

[0032] The wound dressing 130 is configured as an electrode for placement on and around a wound associated with an insertion site IS of a patient. The wound dressing 130 includes a body 232 having a slot 134 configured to receive the catheter tube 142 of the catheter assembly 140 with the catheter tube 142 placed at the insertion site IS of the patient and the wound dressing 130 positioned on and around the associated wound.

[0033] The body 232 of the wound dressing 130 is electrically conductive or configured to become electrically conductive under certain conditions. The body 232 of the wound dressing 130 comprises a matrix of a naturally occurring polymer (e.g., cotton [i.e., cellulose]), a synthetic polymer (e.g., hydrogel, polyurethane, etc.), or a composite thereof.

[0034] When the body 232 of the wound dressing 130 is conductive, the matrix includes a metal (e.g., 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.

[0035] If the body 232 of the wound dressing 130 is configured to be conductive, the body 232 becomes conductive when at least partially saturated with bodily fluids, such as sweat, exudate, blood, etc., which include ions for electrical conductivity. Even if the body 232 of the wound dressing 130 is already conductive, such bodily fluids can increase the electrical conductivity.

[0036] The body 232 of the wound dressing 130 may include an antimicrobial agent dispersed therein, the antimicrobial agent being configured to act synergistically with the electrical stimulation to inhibit bacterial growth. 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 that is reduced to nitric oxide within 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 the antimicrobial agent.

[0037] The catheter stabilization device 110 or 310 includes an anchor pad 212 and a retainer 214 or 314 coupled to the anchor pad 212 . The anchor pad 212 is configured to adhere to the patient's skin near the insertion site IS, as shown in Figures 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.

[0038] The retainer 214 or 314 is configured to stabilize the catheter assembly 140 (e.g., a peripherally inserted central catheter (PICC)) while the catheter tube 142 of the catheter assembly 140 is positioned at the insertion site IS, as shown in Figures 2 and 3. The retainer 214 or 314 may include a suture wing compartment within the body of the retainer 214 or 314 configured to receive the suture wings 246 of the catheter assembly 140 therein. The suture wing compartment may include a post (e.g., post 216) extending from a bottom of the suture wing compartment, the post being configured for insertion into a 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 of or molded from polyurethane.

[0039] The retainer 214 differs from the retainer 314 in that it includes hinged wings 218 coupled to the body of the retainer 214. The hinged wings 218 are configured to open outwardly to insert the suture wings 246 of the catheter assembly 140 into the suture wing compartment of the retainer 214. The hinged wings 218 are also configured to close inwardly and snap together with the body of the retainer 214 to lock the suture wings 246 of the catheter assembly 140 within the suture wing compartment of the retainer 214. The hinged wings 218 include tabs and the body of the retainer 214 includes recesses that allow the hinged wings 218 to snap together with the body of the retainer 214.

[0040] The retainer 314 differs from the retainer 214 in that the retainer 314 includes a cover 318 that is removably or fixedly coupled to the body of the retainer 314. If removably coupled, the cover 318 is configured to snap-fit ​​with the body of the retainer 314 to lock the suture wings 246 of the catheter assembly 140 within the suture wing compartment of the retainer 314 after the suture wings 246 are inserted therein. Like the retainer 214 and its hinged wings 218, the cover 318 includes tabs and the body of the retainer 314 includes recesses that allow the cover 318 to snap-fit ​​together with the body of the retainer 314. If fixedly coupled, the cover 318 includes a hinged small end portion that allows the hinged small end portion to be lifted away from the body of the retainer 314 for insertion of the suture wings 246 of the catheter assembly 140 into the suture wing compartment of the retainer 314. The non-hinged small end portion of the cover 318 includes a tab and a corresponding portion of the body of the retainer 314 includes a recess that allows the cover 318 to snap together with the body of the retainer 314 to lock the suture wings 246 of the catheter assembly 140 within the suture wing compartment of the retainer 314 after the suture wings 246 are inserted therein.

[0041] The electrical stimulation means includes a power source and external circuitry between the catheter stabilization device 110 or 310 and the wound dressing 130 (shown in Figures 2 and 3) for applying the electrical stimulation.

[0042] Although not shown, the power source is a battery (e.g., a microbattery), which may be either a replaceable battery or a rechargeable battery. The battery may be disposed in a battery compartment in the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, in the hinged wings 218 of the retainer 214, or in the cover 318 of the retainer 314. The battery compartment may be configured to mate with a slide lock cover of the battery compartment to access the battery compartment as needed to replace the replaceable battery. Alternatively, the battery compartment may be sealed inaccessible with a rechargeable battery therein to ensure hassle-free operation of the catheter stabilization device 110 or 310. The retainer 214 or 314 may include a charging port 222 electrically coupled to the rechargeable battery for charging the rechargeable battery as needed.

[0043] The external circuit includes a pair of electrical leads 120 extending from the catheter stabilization device 110 or 310 for connection with the wound dressing 130, or electrical contacts electrically coupled to a power source (e.g., electrical contacts on the posts). Although the electrical leads 120 are shown as being comprised of coated metal wiring, the electrical leads 120 may alternatively be comprised of conductive paint, or conductive paint, optionally in combination with coated metal wiring. The conductive paint may be applied along the catheter tube 142 from the electrical contacts of the catheter stabilization device 110 or 310 electrically coupled to the power source or to the catheter stabilization device 110 or 310, to about 3 cm or less from the proximal end of the catheter tube 142, such that the conductive paint is in contact with the wound dressing 130.

[0044] The electrical stimulation means may also include an integrated circuit disposed within the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, within the hinged wings 218 of the retainer 214, or within the cover 318 of the retainer 314. The integrated circuit includes at least a power supply circuit and a control circuit. While the wound healing system 100 is in use, the power supply circuit is coupled to an external circuit. The power supply circuit is configured to transmit power from a power source through the external circuit to the wound dressing 130. The control circuit is configured to regulate how power is provided to the wound dressing 130 through the power supply circuit and the external circuit.

[0045] The integrated circuit may be configured to regulate the power in several different ways. For example, the integrated circuit may be configured to regulate the power such that a low intensity current of between about 200 and 1000 mA is continuously delivered to the wound dressing 130 for more than one second at a time. Such current may have a specific polarity. It is believed that the application of such a low intensity current not only activates wound healing cells in the wound, but also promotes the migration of wound healing cells. Also, the integrated circuit may be configured to regulate the power such that a high voltage current of between about 50 and 150 V is delivered to the wound dressing 130 in 1 ms pulses or pulses of less than 1 ms. Such current may have an alternating polarity or a specific polarity. It is believed that the application of such a high voltage current inhibits bacterial growth by disrupting the integrity of the bacterial membrane through electrical stimulation.

[0046] The integrated circuit may include biofeedback logic configured to detect changes in impedance through the patient's skin or wound dressing 130. The biofeedback logic may also be configured to adjust how power is delivered to the wound dressing 130 in response to the changes in impedance. In addition to regulating how power is delivered to the wound dressing 130, the biofeedback logic may be configured to detect excessive bleeding through changes in impedance.

[0047] Although not necessarily part of the electrical stimulation means, the body of the retainer 214 or 314 of the catheter stabilization device 110 or 310, the hinged wings 218 of the retainer 214, or the cover 318 of the retainer 314 may include one or more LEDs 224 configured to indicate when the electrical stimulation means is active, what mode the electrical stimulation means is being used, when the batteries need to be charged or replaced, etc.

[0048] The wound healing system 100 may further include a controller 150, such as a bedside controller, handheld controller, or smartphone, having a communication module configured to communicate with a communication module in the retainer 214 or 314 of the catheter stabilization device 110 or 310 via Wi-Fi, Bluetooth, or the like. The controller 150 is configured to allow a user of the controller 150 to adjust how power is provided to the wound dressing 130. For example, the controller 150 may be configured to allow a user to freely adjust the frequency, duration, voltage, or polarity of the power provided to the wound dressing 130, which may be 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 for automatically adjusting the frequency, duration, voltage, or polarity of the power provided to the wound dressing 130.

[0049] The wound healing system 100 may further include a bandage 160 for placement over the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140. The bandage 160 includes a patient-facing surface having a hypoallergenic adhesive configured to adhere to the patient to further stabilize the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140. The bandage 160 may include a transparent window with a reinforced edge made of non-absorbent tricot polyester such that the combination of the wound dressing 130, the catheter stabilization device 110 or 310, and the catheter assembly 140 may be viewed through the transparent window to monitor the wound healing system 100. Of note, if the electrical leads 120 of the external circuit of the electrical stimulation means are made of conductive paint, the bandage 160 may protect the electrical leads 120 from abrasion by limiting their exposure.

[0050] method A method of the wound healing system 100 includes at least a method of using the wound healing system 100. When the catheter assembly 140 is included in the wound healing system 100, using the wound healing system 100 may include an insertion step of inserting the catheter tube 142 of the catheter assembly 140 into a percutaneous insertion site, such as the insertion site IS shown in Figures 2 and 3. The method may also include a stabilization step of stabilizing the catheter assembly 140 in the retainer 214 or 314 of the catheter stabilization device 110 or 310 while the catheter tube 142 of the catheter assembly 140 is positioned at the insertion site IS.

[0051] A method of using the wound healing system 100 generally includes a wound dressing application step of applying the wound dressing 130 around a wound associated with an insertion site IS. The method also includes an adhering step of adhering an anchor pad 212 of the catheter stabilization device 110 or 310 to the patient's skin proximate the insertion site IS. The method also includes an electrical lead connection step of connecting a pair of electrical leads 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 includes painting the electrical leads 120 on the catheter assembly 140 with a conductive paint. The method also includes an electrical stimulation application step of applying electrical stimulation using an electrical stimulation means to heal the wound.

[0052] The method may further include a determination step of determining whether the electrical stimulation means is active by observing one or more LEDs 224 of the retainer 214 or 314, which indicates active electrical stimulation.

[0053] The method further includes the step of regulating how power is supplied to the wound dressing 130 by controlling a controller 150 communicatively connected to the catheter stabilization device 110 or 310 .

[0054] The method may further include another decision step of determining whether the rechargeable battery needs to be charged, and 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 stabilization device 110 or 310. The charging cable connection step may include charging the rechargeable battery.

[0055] The method may further include a positioning step of placing a bandage 160 over the combination of wound dressing 130, catheter stabilization device 110 or 310, and catheter assembly 140 to adhere the combination to the patient for further stabilization.

[0056] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Those skilled in the art will appreciate that additional adaptations and / or modifications may be made in the broader aspects, and these adaptations and / or modifications are also encompassed. Thus, deviations from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A wound healing system comprising: a wound dressing configured as an electrode for placement on and around a wound associated with a percutaneous entry site on a patient; A catheter stabilization device; an electrical stimulation means for applying an electrical stimulus to the wound through the wound dressing to heal or protect the wound; Equipped with The catheter stabilization device comprises: an anchor pad configured to adhere to the patient's skin adjacent the insertion site; a retainer coupled to the anchor pad, the retainer configured to stabilize the catheter assembly while a catheter tube of the catheter assembly is positioned at the insertion site; Including, The electrical stimulation means includes: Power supply, an external circuit disposed between the catheter stabilization device and the wound dressing for applying the electrical stimulus to the wound; A wound healing system comprising:

2. 10. The wound healing system of claim 1, further comprising a 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. 3. The wound healing system of 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 dispersed therein a metal, a salt, a conductive polymer, or a conductive allotrope of carbon.

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

5. 3. The wound healing system of 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 being configured to become conductive when at least partially saturated with bodily fluid.

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

7. 7. The wound healing system of claim 1, wherein the external circuit includes a pair of electrical leads extending from the catheter stabilization device for connection to the wound dressing, the electrical leads being constructed of coated metal wiring, conductive paint, or a combination thereof.

8. 8. The wound healing system of claim 1, wherein the electrical stimulation means includes an integrated circuit disposed on a body of the retainer or on a wing or cover of the retainer for locking a portion of the catheter assembly to the retainer, the integrated circuit including at least a power supply circuit coupled to the external circuit configured to transmit power from the power source to the wound dressing, and a control circuit configured to regulate how the power is supplied to the wound dressing.

9. 9. The wound healing system of claim 8, wherein the integrated circuit is configured to regulate the power such that a low intensity current of between 200 and 1000 mA having a particular polarity is continuously delivered to the wound dressing for more than one second at a time.

10. 9. The wound healing system of claim 8, wherein the integrated circuit is configured to regulate the power such that high voltage current of between 50 and 150 V with alternating or specific polarity is delivered to the wound dressing in 1 ms pulses.

11. 11. The wound healing system of claim 8, wherein the integrated circuit includes biofeedback logic configured to detect changes in impedance through the patient's skin or wound dressing and to adjust how the power is delivered to the wound dressing.

12. 12. The wound healing system of claim 1, wherein the power source is a battery, the battery being 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. 14. The wound healing system of any one of claims 1 to 13, wherein the retainer includes one or more light emitting diodes (LEDs) configured to indicate when the electrical stimulation means is active.

15. 15. The wound healing system of any one of claims 1 to 14, further comprising a controller configured to communicatively connect to the catheter stabilization device, the controller configured to allow a user to adjust how power is supplied to the wound dressing.

16. 1. A wound healing system comprising: a wound dressing configured as an electrode for placement on and around a wound associated with a percutaneous entry site on a patient; a catheter stabilization device; an electrical stimulation means for applying an electrical stimulus to the wound through the wound dressing to heal or protect the wound; Band-Aid and Equipped with The catheter stabilization device comprises: an anchor pad configured to adhere to the patient's skin adjacent the insertion site; a retainer coupled to the anchor pad, the retainer configured to stabilize the catheter assembly while a catheter tube of the catheter assembly is positioned at the insertion site; Including, The electrical stimulation means includes: Power supply, an external circuit disposed between the catheter stabilizing device and the wound dressing for applying the electrical stimulus to the wound, the external circuit including a pair of electrical leads extending from the catheter stabilizing device for connecting to the wound dressing; an integrated circuit disposed on the body of the retainer or on a wing or cover of the retainer for locking a portion of the catheter assembly to the retainer; Including, The integrated circuit comprises: a power supply circuit coupled to the external circuit configured to transmit power from the power supply to the wound dressing; a control circuit configured to regulate how the power is delivered to the wound dressing; At least A wound healing system, wherein the bandage is 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.

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