Sensor-integrated coating material and system

Abstract

In some cases, a wound dressing and a method for coating the wound dressing are provided. A first coating can be applied to a first side of a substantially flexible substrate of the wound dressing. The first side of the substrate can support a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks. The first coating can be applied to at least one connector of the plurality of connectors or at least one electronic component of the plurality of electronic components to reinforce the at least one connector or the at least one electronic component.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to UK Patent Application No. 2003203.3, entitled "SENSOR INTEGRATED DRESSINGS AND SYSTEMS", filed on March 5, 2020, which is hereby incorporated by reference in its entirety.

Background Art

[0002] Embodiments of the present disclosure relate to devices, systems, and methods for tissue monitoring and / or treatment using sensor - integrated or sensor - compatible dressings.

[0003] Description of Related Art Almost all areas of medicine can benefit from improved information about the state of the tissue, organ, or system being treated, especially when such information is collected in real time during treatment. Many types of treatments are still routinely performed without the use of sensor data collection. Instead, such treatments rely on visual inspection by caregivers or other limited means, rather than quantitative sensor data. For example, in the case of wound treatment via a dressing and / or negative pressure wound therapy, data collection is generally limited to visual inspection by a caregiver. In many cases, the underlying wound tissue can be obscured by a bandage or other visual obstruction. Even in seemingly intact, uninjured skin, there may be underlying damage that is not visible to the naked eye, such as vulnerable blood vessels or deeper tissue damage that can lead to ulcers or injury. Similarly, during orthopedic treatments that require immobilization of a limb with a cast or other enclosure, only limited information about the underlying tissue is collected. In the case of internal tissue repair, such as a bone plate, continuous direct sensor-driven data collection is not performed. Additionally, braces and / or sleeves used to support musculoskeletal function do not monitor the function of the underlying muscle or the movement of the limb. Beyond direct treatment, general hospital supplies such as beds and blankets can be improved by adding the ability to monitor patient parameters.

[0004] Accordingly, there is a need for improved sensor monitoring, particularly through the use of sensor-integrated substrates that can be incorporated into existing treatment regimens. SUMMARY OF THE INVENTION

[0005] In some cases, a wound dressing and a method for coating the wound dressing are provided. A coating can be applied on a first side of a substantially flexible substrate of the wound dressing. The first side of the substrate can support a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks. The coating can be applied to the substrate, an electronic track, at least one connector of the plurality of connectors, or at least one electronic component of the plurality of electronic components to encapsulate the dressing and / or reinforce at least one connector or at least one electronic component.

[0006] Any of the wound dressings and / or methods of any of the preceding paragraphs, and / or the wound dressings and / or methods disclosed herein may further comprise one or more of the following features. The coating may be a first coating applied to at least one connector of the plurality of connectors or at least one electronic component of the plurality of electronic components to reinforce at least one connector or at least one electronic component. A second coating can be applied on the first side of the substrate, the second coating comprising a first layer and a second layer, the first layer being applied in a first direction and the second coating being applied in a second direction transverse to the first direction. The second side of the substrate, opposite the first side, can be coated with a third coating.

[0007] Any method of any preceding paragraph and / or any method disclosed herein may include one or more of the following features. The method may further include coating at least some of the plurality of electronic components with a fourth coating. The method may further comprise a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. The third coating may include the same material as that of the second coating applied to the first side of the substrate. The third coating may include a material different from that of the second coating applied to the first side of the substrate. The plurality of electronic components may comprise a plurality of sensors configured to acquire measurements of the wound, at least some of the plurality of sensors being interconnected by a plurality of electrical connections.

[0008] A wound dressing and / or method as described above may further comprise one or more of the following features. A second coating applied to the first side of the substrate, the second coating being capable of including a first layer and a second layer. The first layer may be applied in a first direction, the second layer may be applied in a second direction parallel to the first direction, and the first layer may be offset from the second layer. The second side of the substrate, opposite the first side, can be coated with a third coating.

[0009] Any method of any preceding paragraph and / or any method disclosed herein may include one or more of the following features. The method may further include coating at least some of the plurality of electronic components with a fourth coating. The method may further comprise a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. The third coating may include the same material as that of the second coating applied to the first side of the substrate. The third coating may include a material different from that of the second coating applied to the first side of the substrate. The plurality of electronic components may comprise a plurality of sensors configured to acquire a measurement of a wound, at least some of the plurality of sensors being interconnected by a plurality of electrical connections.

[0010] In some cases, a method for coating a wound dressing may include applying a primer treatment layer to a first side of a substantially flexible substrate of the wound dressing.

[0011] A wound dressing and / or method as described above may further comprise one or more of the following features. A first coating that may be applied over the primer treatment layer on the first side of the substantially flexible substrate of the wound dressing, wherein the first side of the substrate supports a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and the first coating is applied to at least one of the plurality of connectors or at least one of the plurality of electronic components such that at least one connector or at least one electronic component is reinforced, and a second coating is applied on the first side of the substrate.

[0012] Any of the methods of any preceding paragraph and / or the methods disclosed herein may include one or more of the following features. The method may further include coating a second side of the substrate, opposite the first side, with a third coating. The method may further include applying a second primer treatment layer to the second side of the substrate prior to applying the third coating. The first primer treatment layer or the second primer treatment layer may include parylene. The first primer treatment layer or the second primer treatment layer may include parylene C. The method may further include coating at least some of a plurality of electronic components with a fourth coating. The method may further comprise a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. The third coating may include the same material as that of the second coating applied to the first side of the substrate. The third coating may include a material different from that of the second coating applied to the first side of the substrate. The plurality of electronic components includes a plurality of sensors configured to obtain measurements of a wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections.

[0013] In some cases, the wound dressing device may comprise a substantially flexible substrate having a first side that supports a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and a primer treatment layer on the first side of the substantially flexible substrate of the wound dressing.

[0014] The wound dressing and / or method as described above may further comprise one or more of the following features. A first coating on the first side of the substrate may be applied over a primer treatment layer and over the area of at least one of a plurality of connectors or to at least one of a plurality of electronic components to reinforce the at least one connector or the at least one electronic component. A second coating may be on the first side of the substrate, and a third coating may be on the second side of the substrate, opposite the first side.

[0015] Any of the wound dressings of any preceding paragraph and / or the wound dressings disclosed herein may include one or more of the following features. The dressing may further comprise a second primer treatment layer applied to the second side of the substrate between the substrate and the third coating. The first primer treatment layer or the second primer treatment layer may include parylene. The first primer treatment layer or the second primer treatment layer may include parylene C. The dressing may further comprise at least some of a plurality of electronic components coated with a fourth coating. The dressing may further comprise a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. The third coating may include the same material as that of the second coating on the first side of the substrate. The third coating may include a material different from that of the second coating on the first side of the substrate. The plurality of electronic components may comprise a plurality of sensors configured to acquire measurements of the wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections.

[0016] In some cases, the wound dressing and / or method described herein may further comprise a coating having varying thicknesses or a uniform thickness.

[0017] In some cases, the wound dressing and / or method described herein may further comprise a hydrophilic coating on a side of the substrate that faces away from the wound so as to draw fluid through the substrate.

[0018] In some cases, the wound dressing and / or method described herein may further comprise a first non - stretchable coating having various shapes or contours.

[0019] In some cases, the wound dressing and / or method described herein may further comprise a first non - stretchable coating on a side of the substrate that faces away from the wound.

[0020] In some cases, the wound dressing and / or method described herein may further include a silicone material for encapsulating the substrate.

[0021] In some cases, the wound dressing and / or method described herein may further include an adhesive material for encapsulating the substrate.

[0022] In some cases, the wound dressing and / or method described herein may further include an adhesive material for encapsulating the substrate.

[0023] In some cases, the wound dressing and / or method described herein may further include applying various coatings in any order.

[0024] In some cases, the wound dressing and / or method described herein may further comprise a coating that is partially or entirely made of a flexible material but not a stretchable material.

[0025] In some cases, the wound dressing and / or method described herein may further comprise a coating that is partially or entirely made of a stretchable material.

[0026] In some cases, the wound dressing and / or method described herein may further comprise a coating that comprises, in part or in whole, the same material.

[0027] In some cases, the wound dressing and / or method described herein may further comprise a coating that is optically clear, transparent, and / or colorless.

[0028] In some cases, the kit may include either a dressing of any preceding paragraph or a dressing disclosed herein, and a negative pressure wound therapy device configured to supply negative pressure to a wound covered by the dressing.

[0029] Any of the kits of any preceding paragraph and / or the kits disclosed herein may include one or more of the following features. The dressing and the negative pressure wound therapy device may be sterilizable. The kit may include a secondary dressing configured to be positioned over the dressing.

Brief Description of the Drawings

[0030] Embodiments of the present disclosure are described hereinbelow by way of example only with reference to the accompanying drawings.

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[0032] The embodiments disclosed herein relate to at least one of an apparatus and method for monitoring or treating biological tissue using a sensor-enabled substrate. The embodiments disclosed herein are not limited to treating or monitoring a particular type of tissue or injury, but instead, the sensor-enabled technology disclosed herein is broadly applicable to any type of therapy that can benefit from a sensor-enabled substrate. Some implementations utilize sensors and data collection that are trusted by medical practitioners to make both diagnostic and patient management decisions.

[0033] Certain embodiments disclosed herein relate to the use of sensors mounted on or embedded within substrates configured for use in the treatment of both intact and damaged human or animal tissue. Such sensors may collect information about the surrounding tissue and transmit such information to a computing device or caregiver for use in further treatment. In certain implementations, such sensors may be attached to the skin anywhere on the body, including areas for monitoring arthritis, temperature, or other areas prone to problems and requiring monitoring. The sensors disclosed herein may also incorporate markers, such as radiopaque markers, to indicate the presence of the device, for example, prior to performing an MRI or other technique.

[0034] The sensor embodiments disclosed herein can be used in combination with clothing. Non-limiting examples of clothing for use with the sensor embodiments disclosed herein include shirts, pants, trousers, dresses, undergarments, outerwear, gloves, shoes, hats, and other suitable apparel. In certain embodiments, the sensor embodiments disclosed herein can be welded or laminated to specific articles of clothing. The sensor embodiments may be printed directly onto the clothing and / or embedded in the fabric. Breathable and printable materials such as microporous membranes may also be suitable.

[0035] The sensor embodiments disclosed herein can be incorporated into cushioning materials or bed pads, such as within a hospital bed, to monitor patient characteristics such as any of the characteristics disclosed herein. In certain embodiments, a disposable film containing such a sensor can be placed on a hospital bed and removed / replaced as needed.

[0036] In some implementations, the sensor embodiments disclosed herein can incorporate energy harvesting such that the sensor embodiments operate autonomously. For example, energy can be harvested from a thermal energy source, a kinetic energy source, a chemical gradient, or any suitable energy source.

[0037] The sensor embodiments disclosed herein can be utilized in rehabilitation devices and treatments, including sports medicine. For example, the sensor embodiments disclosed herein can be used in braces, sleeves, wraps, supports, and other suitable items. Similarly, the sensor embodiments disclosed herein can be incorporated into sports equipment such as helmets, sleeves, and / or pads. For example, such sensor embodiments can be incorporated into a protective helmet to monitor characteristics such as acceleration, which may be useful for diagnosing concussions.

[0038] The sensor embodiments disclosed herein can be used in cooperation with surgical devices, such as the NAVIO surgical system by Smith&Nephew Inc. In some implementations, the sensor embodiments disclosed herein can communicate with such surgical devices to guide the placement of the surgical device. In some implementations, the sensor embodiments disclosed herein can monitor blood flow to or from a potential surgical site or confirm the absence of blood flow to the surgical site. Additional surgical data can be collected to assist in preventing scarring and monitoring areas away from the affected area.

[0039] To further assist surgical techniques, the sensors disclosed herein can be incorporated into a surgical drape to provide information about tissue under the drape that may not be immediately visible to the naked eye. For example, a sensor-embedded flexible drape can have sensors advantageously positioned to provide improved area-focused data collection. In certain implementations, the sensor embodiments disclosed herein can be incorporated at the boundary or within the drape to create a fencing that restricts / controls the surgical defect.

[0040] The sensor embodiments disclosed herein can also be utilized for pre-operative assessment. For example, such sensor embodiments can be used to collect information about potential surgical sites, such as by monitoring the skin and underlying tissue for possible incision sites. For example, perfusion levels or other suitable characteristics can be monitored at the surface of the skin and deeper within the tissue to evaluate whether an individual patient may be at risk of surgical complications. Sensor embodiments such as those disclosed herein can be used to assess the presence of a microbial infection and provide an indication for the use of an antimicrobial agent. Further, the sensor embodiments disclosed herein can collect additional information in deeper tissue, such as identifying pressure ulcers or pressure injuries and / or adipose tissue levels.

[0041] The sensor embodiments disclosed herein can be utilized for cardiovascular monitoring. For example, such sensor embodiments can be incorporated into a flexible cardiovascular monitor that can be placed on the skin to monitor the characteristics of the cardiovascular system and communicate such information to another device and / or caregiver. For example, such a device can monitor heart rate, blood oxygenation, and / or the electrical activity of the heart. Similarly, the sensor embodiments disclosed herein can be utilized for neurophysiological applications, such as monitoring the electrical activity of neurons.

[0042] The sensor embodiments disclosed herein can be incorporated into implantable devices, such as implantable orthopedic implants, including flexible implants. Such sensor embodiments can be configured to collect information regarding the implant site and transmit this information to an external source. In some cases, an internal source can also provide power to such implants.

[0043] The sensor embodiments disclosed herein can also be utilized to monitor biochemical activities on or beneath the surface of the skin, such as the accumulation of lactate in muscle or the production of sweat on the surface of the skin. In some cases, other characteristics, such as glucose concentration, urine concentration, tissue pressure, skin temperature, skin surface conductivity, skin surface resistivity, skin hydration, skin maceration, and / or skin tears, can be monitored.

[0044] The sensor embodiments disclosed herein can be incorporated into ear, nose, and throat (ENT) applications. For example, such sensor embodiments can be utilized to monitor the recovery from ENT-related surgeries, such as monitoring wound healing within sinus passages.

[0045] The sensor embodiments disclosed herein can include sensor printing techniques involving encapsulation, such as encapsulation using a polymer film. Such a film can be constructed using any of the polymers described herein, such as polyurethane. Encapsulation of the sensor embodiments can provide waterproofing for the electronic device and protection from local tissue, local fluids, and other sources of potential damage.

[0046] In certain embodiments, the sensors disclosed herein can be incorporated into an organ protection layer. Such a sensor-embedded organ protection layer can both protect the organ of interest and confirm that the organ protection layer is in place and providing protection. Further, the sensor-embedded organ protection layer can be utilized to monitor the underlying organ, such as by monitoring blood flow, oxygenation, and other suitable markers of organ health. In some cases, the sensor-enabled organ protection layer can be used to monitor a transplanted organ, such as by monitoring the fat and muscle content of the organ. Further, the sensor-enabled organ protection layer can be used to monitor the organ during transplantation and after transplantation, such as during organ rehabilitation.

[0047] The sensor embodiments disclosed herein can be incorporated into the treatment of wounds (disclosed in more detail below), or into a variety of other applications. Non-limiting examples of additional uses for the sensor embodiments disclosed herein include monitoring and treating intact skin, cardiovascular applications such as monitoring blood flow, orthopedic applications such as monitoring limb movement and bone repair, neurophysiological applications such as monitoring electrical impulses, and any other tissue, organ, system, or condition that can benefit from improved sensor-enabled monitoring.

[0048] Wound therapy Some of the systems and methods disclosed herein relate to wound therapy for the human or animal body. Accordingly, any reference to a wound herein may refer to a wound on the human or animal body, and any reference to the body herein may refer to the human or animal body. The disclosed technology embodiments may relate to preventing or minimizing damage to physiological or biological tissue, with or without negative pressure, including, for example, a source of negative pressure and wound dressing components and devices, or treating damaged tissue (e.g., a wound as described herein). Wound overlays and packing materials, or, if any, devices and components with an inner layer, may be collectively referred to as dressings. In some cases, a wound dressing may be provided for use without negative pressure.

[0049] As used herein, the term "wound" may include an injury to biological tissue that can be caused by a cut, blow, or other impact, typically an impact that cuts or breaks the skin. A wound can be a chronic or acute injury. Acute wounds result from surgery or trauma. They progress through the stages of healing within a predictable time frame. Chronic wounds typically begin as acute wounds. Acute wounds can become chronic when they do not follow the stages of healing, resulting in prolonged recovery. The transition from acute to chronic wounds is thought to be due to the patient being immunocompromised.

[0050] Examples of chronic wounds can include, for example, venous ulcers (such as those occurring in the legs), which account for most chronic wounds and mainly affect the elderly, diabetic ulcers (e.g., foot or ankle ulcers), peripheral arterial disease, pressure ulcers, pressure injuries, or epidermolysis bullosa (EB).

[0051] Examples of other wounds include, but are not limited to, abdominal wounds, or other large or incisional wounds, laceration wounds, acute wounds, chronic wounds, subacute wounds and laceration wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, pressure injuries, stomas, surgical wounds, traumatic ulcers and venous ulcers, as a result of surgery, trauma, sternotomy, fasciotomy, or any other condition.

[0052] Wounds can also include deep tissue injury. Deep tissue injury is a term proposed by the National Pressure Ulcer Advisory Panel (NPUAP) to describe a specific form of pressure ulcer. These ulcers have been described by clinicians over the years using terms such as purple pressure ulcers, ulcers at risk of worsening, and blanching over bony prominences.

[0053] Wounds can also include pressure injuries. Pressure injuries are localised damage to the skin and / or underlying soft tissue, usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury results from strong and / or prolonged pressure, or pressure in combination with shear. The tolerance of soft tissue to pressure and shear can also be affected by the microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue.

[0054] Wounds can also include tissues at risk of becoming a wound as discussed herein. For example, tissues at risk can include tissues over bony prominences (at risk of deep tissue injury / damage) that have the potential to be transected (e.g., joint replacement / surgical revision / reconstruction) or tissues prior to surgery (e.g., knee tissues).

[0055] Some of the systems and methods disclosed herein relate to methods of treating wounds using the techniques disclosed herein in combination with one or more of advanced footwear, patient turning, offloading (e.g., offloading of diabetic foot ulcers), treatment of infections, systemicics, antibacterial agents, antibiotics, surgery, tissue removal, effects on blood flow, physical therapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, activated ozone, antibiotics, antibacterial agents, etc.

[0056] Alternatively or additionally, the wound can be treated using conventional advanced wound care (which may also be referred to as non-negative pressure therapy) not assisted by the use of topical negative pressure (TNP) and / or applied negative pressure.

[0057] Advanced wound care can include the use of antimicrobial agents and / or wound cleansers in absorbent dressings, occlusive dressings, wound dressings or adjuncts, the use of pads (e.g., for cushioning or compression therapy such as stockings or bandages), etc.

[0058] In some cases, the wound dressing includes one or more absorbent layers. The absorbent layer can be a foam or a superabsorbent.

[0059] In some cases, the disclosed techniques can be used with non-negative pressure dressings. A non-negative pressure wound dressing suitable for providing protection at the wound site can include an absorbent layer for absorbing wound exudate and a shielding element for at least partially obscuring the visual recognition of the wound exudate absorbed by the absorbent layer during use. The shielding element can be partially translucent. The shielding element can be a masking layer.

[0060] In some cases, the non-negative pressure wound dressings disclosed herein include a wound contact layer and the absorbent layer overlaps the wound contact layer. The wound contact layer can carry an adhesive portion for forming a substantially fluid-tight seal over the wound.

[0061] In some cases, the wound dressing disclosed herein further comprises superabsorbent fibers, or a layer of viscose fibers or polyester fibers.

[0062] In some cases, the wound dressing disclosed herein further comprises a backing layer. The backing layer may be a transparent or opaque film. Typically, the backing layer comprises a polyurethane film (typically, a transparent polyurethane film).

[0063] In some cases, the foam may be an open-cell foam or a closed-cell foam, and typically may be an open-cell foam. The foam may be hydrophilic.

[0064] The wound dressing may include a permeable layer, which can be a foam. The permeable layer can be a polyurethane foam laminated to a polyurethane film.

[0065] The non-negative pressure wound dressing may be a compression bandage. Compression bandages are known for use in the treatment of edema and other venous and lymphatic disorders of the lower extremities, for example. In some cases, the compression bandage may comprise a bandage system including an inner layer facing the endothelium and an elastic outer layer, the inner layer comprising a first ply of foam and a second ply of an absorbent nonwoven web, and the inner and outer layers being sufficiently elongated to be wrapped around the patient's limb.

[0066] Negative pressure wound therapy In some cases, the treatment of wounds can be carried out using negative pressure wound therapy. Embodiments of the present disclosure are generally understood to be applicable for use in TNP systems. Briefly, negative pressure wound therapy helps to close and heal many forms of "difficult to heal" wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, removing excessive exudate, and can reduce the bacterial load (and thus the risk of infection). In addition, the therapy can reduce wound discomfort and lead to earlier healing. The TNP therapy system may also assist in the healing of surgically closed wounds by helping to remove fluids and stabilizing the tissue at the parallel positions of closure. Further beneficial uses of TNP treatment can be found in grafts and flaps where it is important to remove excessive fluids and the graft is required to be in close proximity to the tissue to ensure tissue viability.

[0067] Negative pressure therapy can be used for the treatment of open or chronic wounds that are too large to close naturally or that do not heal with the application of negative pressure to the wound site. Typical negative pressure (TNP) therapy or negative pressure wound therapy (NPWT) involves placing a fluid-impermeable or semi-permeable cover over the wound, using various means to seal the cover to the patient's tissue surrounding the wound, and connecting a negative pressure source (such as a vacuum pump) to the cover in such a way that negative pressure is created and maintained under the cover. Such negative pressure is thought to promote wound healing by promoting the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while removing excessive fluids that may contain harmful cytokines or bacteria.

[0068] Some of the dressings used for NPWT can include different types of materials and layers, such as gauze, pads, foam pads, or multilayer wound dressings. An example of a multilayer wound dressing is the PICO dressing, commercially available from Smith&Nephew, which includes a wound contact layer and a superabsorbent layer below the backing layer to provide a canisterless system for treating wounds with NPWT. The wound dressing may be sealed to a suction port that provides a connection to a long tube that may be used to pump fluid from the dressing or to transmit negative pressure from a pump to the wound dressing. In addition, RENASYS-F, RENASYS-G, RENASYS-AB, and RENASYS-F / AB, commercially available from Smith&Nephew, are further examples of NPWT wound dressings and systems. Another example of a multilayer wound dressing is the ALLEVYN Life dressing, commercially available from Smith&Nephew, which includes a moist wound environment dressing used to treat wounds without using negative pressure.

[0069] As used herein, a reduced pressure or negative pressure level, such as -X mmHg, represents a pressure level relative to normal ambient pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg reflects an absolute pressure that is X mmHg lower than 760 mmHg, or, in other words, an absolute pressure of (760 - X) mmHg. In addition, a negative pressure that is "lower" or "less" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). A negative pressure that is "higher" or "greater" than -X mmHg corresponds to a pressure further from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg). In some cases, local ambient pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.

[0070] In some cases of the wound closure devices described herein, an increase in wound contraction can lead to an increase in tissue expansion in the surrounding wound tissue. This effect may, in some cases, be increased by changing the force applied to the tissue in conjunction with an increase in the tensile force applied to the wound by an embodiment of the wound closure device, for example, by changing the negative pressure applied to the wound over time. In some cases, the negative pressure may be changed over time using, for example, a sine wave, a square wave, or in synchronization with one or more physiological indicators (such as heart rate).

[0071] Any of the embodiments disclosed herein may be used in combination with any of the features disclosed in one or more of WO2010 / 061225, US2016 / 114074, US2006 / 0142560, and US5,703,225, which describe absorbent materials, WO2013 / 007973, which describes a non-negative pressure wound dressing, GB1618298.2 (filed Oct. 28, 2016), GB1621057.7 (filed Dec. 12, 2016), and GB1709987.0 (filed Jun. 22, 2017), which describe multi-layer wound dressings, EP2498829 and EP1718257, which describe wound dressings, WO2006 / 110527, US6,759,566, and US2002 / 0099318, which describe compression bandages, US8,235,955 and US7,753,894, which describe wound closure devices, WO2013 / 175306, WO2016 / 174048, US2015 / 0190286, US2011 / 0282309, and US2016 / 0339158, which describe negative pressure wound therapy dressings, wound dressing components, wound treatment devices, and methods. The disclosure of each of these applications is hereby incorporated by reference in its entirety into this specification.

[0072] Substrate support sensor A wound dressing incorporating several electronic components including one or more sensors can be utilized to monitor the characteristics of a wound. Collecting and analyzing data from a wound can provide useful insights into determining whether the wound is on a healing curve, selecting an appropriate therapy, determining whether the wound has healed, and the like.

[0073] In some embodiments, several sensor technologies can be used in a wound dressing or one or more components forming part of the entire wound dressing device. For example, as illustrated in FIGS. 1A - 1C, one or more sensors can be incorporated onto or within a substrate (such a substrate can be referred to as a "sensor - integrated substrate"). The substrate is illustrated as having a square shape, but it will be understood that the substrate can have other shapes such as rectangular, circular, oval, etc. In some cases, the substrate supporting one or more sensors can be provided as an individual material layer that is placed directly or indirectly over or within the wound. The sensor - integrated substrate can be part of a larger wound dressing device. In some cases, the sensor - integrated substrate is part of a single unit dressing. Additionally or alternatively, the sensor - integrated substrate is placed directly or indirectly over or within the wound and can then be covered by a secondary wound dressing that can include one or more of a gauze, a foam, or other wound packaging material, a superabsorbent layer, a drape, a fully integrated dressing such as a Pico or Allevyn Life dressing manufactured by Smith & Nephew.

[0074] The sensor-integrated substrate can be placed in contact with the wound, allowing fluid to pass through the substrate with little or no damage to the tissue within the wound. The substrate can be flexible, elastic, stretchable, or extensible, or substantially so, to conform to or cover the wound. For example, the substrate can be made of one or more stretchable or substantially stretchable materials such as polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymers (FEP) and copolymer materials, or another suitable material.

[0075] In some cases, the substrate can include one or more flexible circuit boards that can be formed of flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymers (FEP) and copolymers. One or more sensors can be incorporated into a two-layer flexible circuit. In some scenarios, one or more circuit boards can be multilayer flexible circuit boards.

[0076] In some cases, the sensor-integrated substrate can incorporate an adhesive that adheres to wet or dry tissue. In some cases, one or more sensors, where one or more flexible circuits can be positioned, can be incorporated into any layer of the wound dressing. For example, the wound contact layer can have cutouts or slits that allow for one or more sensors that protrude from the lower surface of the wound contact layer and directly contact the wound. In some situations, one or more sensors can be incorporated into or encapsulated within other components of the wound dressing, such as an absorbent layer.

[0077] As shown in FIG. 1A, the sensor-integrated substrate 100A can support a plurality of electronic components and a plurality of electronic connections that interconnect at least some of the components. The electronic components can be one or more of any of the electronic components described herein, such as sensors, amplifiers, capacitors, resistors, inductors, controllers, processors, etc. The electronic connections can electrically connect one or more of the electronic components. The electronic connections can be tracks printed on the substrate, such as the use of copper, conductive inks (such as silver ink, graphite ink). At least some of the electronic connections can be flexible or stretchable, or substantially flexible or stretchable.

[0078] The plurality of electronic components can include one or more impedance or conductivity sensors 110 that can be arranged in an outer 4×4 grid and an inner 4×4 grid, as illustrated in FIGS. 1A-1C. The sensor 110 is illustrated as pads configured to measure the impedance or conductivity of tissue across any pair of pads. Two (or more) excitation pads 115 are arranged as illustrated to provide an excitation signal across the pads, which is conducted by the tissue and in response to which the impedance or conductance of the tissue can be measured across the pads 110. Electrical components such as one or more amplifiers 120 can be used to measure the impedance or conductance of the tissue. The measured values of impedance or conductance can be used to distinguish between living and dead tissue and to monitor the progress of healing, etc. The arrangement of the pads 110 within the inner and outer grids can be used to measure the impedance or conductance of the wound, the outer perimeter of the wound, or the tissue or area surrounding the wound.

[0079] The plurality of electronic components may include one or more temperature sensors 130 configured to measure the temperature of the wound or the surrounding tissue. For example, nine temperature sensors are disposed around the outer periphery of the substrate 100A. The one or more temperature sensors may include one or more thermocouples or thermostats. The one or more temperature sensors may be calibrated, and the data obtained from the one or more sensors may be processed to provide information about the wound environment. In some cases, ambient sensors that measure the ambient air temperature may be used to help eliminate problems associated with ambient temperature shifts.

[0080] The plurality of electronic components may include one or more optical sensors 150. The one or more optical sensors 150 may be configured to measure the appearance of the wound or image the wound. In some cases, a light source or illumination source that emits light and a light sensor or detector that detects the light reflected by the wound are used as the one or more optical sensors. The light source can be a light-emitting diode (LED), for example, one or more white LEDs, red, green, blue (RGB) LEDs, ultraviolet (UV) LEDs, etc. The light sensor can be one or more of an RGB sensor configured to detect color, an infrared (IR) color sensor, a UV sensor, etc. In some cases, both the light source and the detector will be pressed against the skin, whereby light will penetrate into the tissue and exhibit the spectral characteristics of the tissue itself. In some scenarios, the one or more optical sensors may include imaging devices such as charge-coupled devices (CCD), complementary metal-oxide-semiconductor (CMOS) image sensors, etc.

[0081] In some cases, ultra-high brightness LEDs, RGB sensors, and polyester optical filters can be used as components of one or more optical sensors for measuring through tissue color differentiation. For example, since the color of a surface can be measured from reflected light, the color can be measured from the light that first passes through the tissue for a given geometry. This can include color perception from diffused light such as that diffused from an LED in contact with the skin. In some cases, the LED can be used with a proximal RGB sensor to detect light diffused through the tissue. The optical sensor can image using diffused internal light or surface reflected light.

[0082] One or more of a plurality of electronic components can be controlled by a control module. The control module can receive and process one or more measurement values acquired by one or more sensors. An external control module can be connected to at least some of the plurality of electronic components via a connector 140. In some cases, the connector 140 can be positioned at the end of a conductive track portion as illustrated in FIG. 1B, or attached to the conductive track portion at a position remote from the end as illustrated in FIG. 1A or FIG. 1C (e.g., attached to the top of the track portion with an adhesive). The control module can include one or more controllers or microprocessors, memory, etc. In some cases, one or more controllers can be positioned on a substrate and the connector 140 is not used. In some cases, data and commands can be communicated wirelessly, such as by a transceiver positioned on the substrate, and the connector 140 is not used.

[0083] In some cases, additional or alternative sensors, such as one or more pH sensors, pressure sensors, perfusion sensors, etc., may be positioned on the substrate.

[0084] In some cases, the substrate can be perforated as illustrated in FIGS. 1B and 1C. A plurality of perforations 160 can be formed within the substrate 100B to allow fluid to pass through the substrate. In conjunction with the application of negative pressure wound therapy, it may be advantageous to use a perforated substrate, during which a reduced pressure is applied to a wound covered by a dressing, causing removal of fluid (such as wound exudate) from the wound. The perforations 160 can be formed around a plurality of electronic components and connections as illustrated in FIGS. 1B and 1C. The perforations 160 can be formed as slits or holes. In some cases, the perforations 160 may be small enough to help prevent ingrowth of tissue while allowing fluid to pass through the substrate.

[0085] In some cases, any of the wound dressings or wound dressing components described herein can be part of a kit that also includes a negative pressure wound therapy device. One or more components of the kit, such as a sensor-enabled substrate, a secondary dressing, or a negative pressure wound therapy device, can be sterilized.

[0086] Any of the embodiments disclosed herein can be used in conjunction with any of the embodiments described in International Patent Publication No. WO2017 / 195038, entitled "SENSOR ENABLED WOUND MONITORING AND THERAPY APPARATUS", International Patent Publication No. WO2018 / 189265, entitled "COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS", International Patent Application No. PCT / EP2018 / 069886, entitled "SKEWING PADS FOR IMPEDANCE MEASUREMENT", and International Patent Application No. PCT / EP2018 / 075815, entitled "SENSOR POSITIONING AND OPTICAL SENSING FOR SENSOR ENABLED WOUND THERAPY DRESSINGS AND SYSTEMS", each of which is hereby incorporated by reference in its entirety.

[0087] Enclosure and Stress Relief In some cases, it may be desirable for the substrate to be stretchable or substantially stretchable in order to better conform to or cover the wound, but at least some of the electronic components or connections may not need to be stretchable or flexible. In such cases, when the substrate is positioned within or on the wound, unwanted or excessive local strain or stress can be exerted on one or more electronic components, such as the support area or mounting portion of the electronic component. For example, such stress can be caused by patient movement, changes in the shape or size of the wound (e.g., due to its healing), etc. Such stress can cause movement, detachment, or malfunction of one or more electronic components or connections (e.g., generation of an open circuit from a disconnected pin or another connector). Alternatively or additionally, it may be desirable to maintain the position of one or more electronic components, such as one or more sensors, relative to the wound in the same or substantially the same location or area (such as in contact with the wound) so that the measurements collected by the one or more electronic components accurately capture changes over time in the same or substantially the same location or area of the wound. The surface of the stretchable substrate may move, for example, when the patient moves, but it may be desirable to maintain the same or substantially the same position of one or more electronic components relative to the wound.

[0088] To address these issues, in some cases, a non-stretchable or substantially non-stretchable coating (such a coating may also be referred to as a "hard coat") can be applied to one or more electronic components, one or more electronic connections, etc. The hard coat can provide one or more of reinforcement or stress relief for one or more electronic components, one or more electronic connections, etc. The hard coating can be formed from an acrylic or modified urethane material. For example, the hard coat can be one or more of Dymax 1901-M, Dymax 9001-E, Dymax 20351, Dymax 20558, Henkel Loctite 3211, or another suitable material. The hard coat can have a viscosity of about 13,500 cP to 50,000 cP before curing, or can have a viscosity of about 3,600 cP to about 6,600 cP before curing. In some cases, the hard coat can have a viscosity of 50,000 cP or less. The hard coat can have a hardness of about D40 to about D65 and / or a linear shrinkage of about 1.5% to 2.5%.

[0089] In some cases, another coating(s) can be applied to encapsulate or coat the substrate, or one or more of the components supported by the substrate, such as an electronic connection or an electronic component. The coating can provide biocompatibility, shield or protect the electronic circuit from contact with liquid, provide a pad for the electronic component to increase patient comfort, etc. As used herein, biocompatibility can mean conforming to one or more applicable standards such as ISO10993 or USP Class VI. Such a coating can also be referred to as a "conformal coat" or a "soft coat". The soft coat can be stretchable or substantially stretchable. The soft coat can be hydrophobic or substantially hydrophobic.

[0090] The soft coat can be formed from one or more suitable polymers, 1072-M adhesives (such as Dymax 1072-M), 1165-M adhesives (such as Dymax 1165-M), adhesives such as Dymax 1-20771, parylene (such as parylene C), silicone, epoxy, urethane, acrylated urethane, acrylated urethane alternatives (such as Henkel Loctite 3381), or other suitable biocompatible and substantially stretchable materials. The soft coat can be, for example, a thin coating from about 80 microns or less to several millimeters or more. The soft coat can have a hardness lower than about A100, A80, A50 or less. The soft coat can have an elongation at break exceeding about 100%, 200%, 300% or more. The soft coat can have a viscosity of about 8,000 to 14,500 centipoise (cP). In some cases, the coating can have a viscosity of about 3,000 cP or more. In some cases, the coating can have a viscosity of less than about 3,000 cP.

[0091] Any of the hard coats or soft coats described herein can be applied by one or more of curing by one or more of lamination, adhesion, welding (such as ultrasonic welding), light, UV, heat (such as heating), etc. Any of the hard or soft coats described herein can be transparent or substantially transparent to facilitate light sensing. Any of the coatings described herein can retain adhesion strength when subjected to sterilization such as EtO sterilization. Any of the coatings described herein can be modified to emit fluorescence, such as under UV light.

[0092] Figures 2A and 2B illustrate cross-sections of a wound dressing that includes a sensor-integrated substrate. The dressing 200A shown in Figure 2A may include a sensor-integrated substrate 205 that supports a plurality of electronic components (shown protruding from the substrate) and a plurality of electrical connections, as described herein. The dressing 200A may include a hard coat 214 that is applied to one or more of the electronic components or connections. In some cases, the hard coat may be applied to the area where the electronic components are connected to the electrical connections. This may reinforce these connections. In some cases, the hard coat may be applied to each of one or more of the electronic components or connections.

[0093] The dressing 200A may include a soft coat 216 that is applied to the entire side of the substrate facing the wound. The soft coat 216 may be applied to the entire area or substantially the entire area of the side of the substrate facing the wound to encapsulate the substrate, the electronic components, and the connections. In some cases, the soft coat 216 may be applied to a specific area of the substrate, such as those areas that support one or more of the electronic components or connections.

[0094] The dressing 200A may include a wound contact layer 218. The wound contact layer 218 may include an adhesive material configured to adhere the substrate to the wound, which may facilitate maintaining contact of one or more sensors with the wound. The wound contact layer 218 may be formed from silicone. The silicone material can be a low-adhesion (or non-adhesive) silicone. The wound contact layer 218 may include a silicone adhesive mounted on a film. In some cases, the wound contact layer 218 may be similar to the material used in the Allevyn Life Non-Bordered dressing manufactured by Smith&Nephew.

[0095] The wound contact layer 218 may be applied to the entire area or substantially the entire area of the side of the substrate facing the wound. In some cases, the contact layer 218 may be applied to a specific area of the substrate, such as those areas that support one or more of the electronic components or connections.

[0096] As illustrated in FIG. 2A, the plurality of perforations 230 can be formed through one or more of the substrate, hard coat, soft coat, and wound contact layer. As described herein, the perforations can be made in areas or regions of the substrate that do not support electronic components or connections.

[0097] The covering 200A can include a protective layer 220 applied to the contact layer 218. The protective layer 220 can be made of paper such as laminated paper. The protective layer 220 can protect the wound contact layer 218 prior to use and facilitate easy application for the user. The protective layer 218 can include a plurality of (e.g., two) handles. The handles can be applied in a folded configuration where a slit separating the handles is covered by one of the handles folded over the slit. In some cases, the protective layer 218 can be similar to the protective layer used in the Allevyn Life Non-Bordered covering.

[0098] As illustrated, the wicking layer 212 can be positioned on the side of the substrate that does not face the opposing wound. The wicking layer 212 can facilitate the passage of fluid through the layer below the wicking layer. For example, the wicking layer can transport fluid away from a lower layer such as the substrate and towards one or more upper layers positioned above the wicking layer 212. Such one or more upper layers can include one or more of the absorbent materials described herein. In some cases, the wicking layer 212 is formed from a foam such as a foam similar to that used in the Allevyn Life Non-Bordered covering. The wicking layer can be stretchable or substantially stretchable.

[0099] As illustrated in the covering material 200B of FIG. 2B, the additional layer of the soft coat 210 can be positioned on the side surface of the base material that does not face the wound of the base material, between the base material and the wicking layer 212. For example, when the base material is formed of a material that is not impermeable to fluids, the soft coat 210 can protect the side surface of the base material that does not face the wound from the fluid. In such a case, the soft coat 210 can be hydrophobic or substantially hydrophobic. The soft coat 210 can be made of the same or different material as the soft coat 218. The soft coat 210 can be perforated as illustrated and described. In some cases, the soft coat can encapsulate the entire base material, including both the side surface facing the wound and the side surface not facing the wound.

[0100] FIGS. 2C and 2D illustrate cross-sections of a wound dressing material including a sensor-integrated base material similar to the wound dressing materials described with reference to FIGS. 2A and 2B. However, the dressing materials illustrated in FIGS. 2C and 2D do not utilize a wound contact layer or a wicking layer. The dressing material 200C shown in FIG. 2C can include a sensor-integrated base material 205 that supports a plurality of electronic components (shown protruding from the base material) and a plurality of electrical connections, as described herein. The dressing material 200C can include a hard coat 214 applied to one or more of the electronic components or connections. In some cases, the hard coat can be applied to the area where the electronic components are connected to the electrical connections. This can reinforce these connections. In some cases, the hard coat can be applied to each of one or more of the electronic components or connections.

[0101] The dressing material 200C can include a soft coat 216 that can be applied to the entire side surface of the base material facing the wound. The soft coat 216 can be applied to the entire or substantially the entire area of the side surface of the base material facing the wound to encapsulate the base material, the electronic components, and the connections. In some cases, the soft coat 216 can be applied to specific areas of the base material, such as those areas that support one or more of the electronic components or connections.

[0102] As illustrated in FIG. 2C, the plurality of perforations 230 can be formed through one or more of the substrate, hard coat, and / or soft coat. As described herein, the perforations can be made in areas or regions of the substrate that do not support electronic components or connections.

[0103] The coating 200C can include a protective layer 220 applied to the substrate, similar to the protective layer 220 described with reference to FIGS. 2A and 2B.

[0104] As illustrated in the coating 200D of FIG. 2D, an additional layer of the soft coat 210 can be positioned over a side surface of the substrate that does not face the wound. For example, the soft coat 210 can protect the side surface of the substrate that does not face the wound from fluid when the substrate is formed from a material that is not impermeable to the fluid. In such cases, the soft coat 210 can be hydrophobic or substantially hydrophobic. The soft coat 210 can be made of the same or a different material as the soft coat 218. The soft coat 210 can be perforated as illustrated and described. In some cases, the soft coat can encapsulate the entire substrate, including the side surface facing the wound and the side surface not facing the wound.

[0105] FIGS. 3A and 3B illustrate a coated sensor-integrated substrate 300. The substrate 300 is illustrated with the side surface 216 that does not face the wound on top. The substrate 300 can be similar to any of the substrates described herein.

[0106] Any of the embodiments disclosed herein can be used in conjunction with any of the embodiments described in International Patent Application No. PCT / EP2018 / 069883 entitled "BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS" and International Patent Application No. PCT / EP2019 / 073026 entitled "COMPONENT POSITIONING AND ENCAPSULATION FOR SENSOR ENABLED WOUND DRESSINGS", both of which are incorporated herein by reference in their entirety.

[0107] Coating of the substrate A substrate having an electronic device can be coated on one or both sides of the substrate to provide support, stress relief, biocompatibility, and / or protection of components on the substrate. The coating can be applied in various combinations to achieve one or more of these goals.

[0108] In some cases, gaps may be present in the coating depending on the application pattern or material of the coating. In some cases, these gaps may appear within a specific area of the substrate where certain features are present. For example, in some cases, the gaps may appear over the electronic tracks, electrical connections, and / or electronic components of the substrate. This may be a function of the different surface conditions between the substrate and the components (such as silver track sections), causing the liquid coating to migrate away from the components or tracks and leaving gaps in the liquid phase of the material after application. An example of these gaps is illustrated in FIG. 4.

[0109] The surface of a substrate having electronic components and tracks can be treated with a material prior to the application of a coating. The treatment may be a liquid adhesive primer that can be applied to a portion or the entire surface of the substrate. This primer treatment may help the coating to be applied to the surface of the substrate (e.g., a track section) and / or adhere better. In some cases, the primer treatment may reduce the difference between the substrate and the electronic components, electrical connections, and / or electrical tracks from the perspective of surface energy. In some cases, a hard coat and / or a soft coat may be applied over the primer treatment on the substrate, electronic components, electrical connections, and / or electrical tracks. The primer treatment layer can be applied in layers of various thicknesses. The primer treatment layer can be applied thinly to about 3 microns (about 3 microns). The primer treatment layer can be applied with a thickness of 1 to 10 microns (about 1 to 10 microns). In some cases, the primer treatment layer may have a thickness of 1 to 600 μm (about 1 to 600 μm). The primer treatment layer may have a thickness of 1 to 500 μm (about 1 to 500 μm), 1 to 200 μm (about 1 to 200 μm), 1 to 130 μm (about 1 to 130 μm), or 1 to 10 μm (about 1 to 10 μm).

[0110] Various materials can be used as a primer treatment on a substrate. For example, in some cases, a parylene coating can be used before applying one or more hard coats or soft coats. The substrate can be placed in a vapor deposition process where a thin layer of parylene is added to the sensor sheet before coating with one or more hard coats or soft coats. One or more hard coats or soft coats can be applied on top of the parylene layer and cured. In some cases, the parylene layer can contain parylene C. The parylene coating can be applied with various layer thicknesses. The parylene layer can be applied thinly to a thickness of about 3 microns. The parylene layer can be applied with a thickness of 1 to 10 microns. In some cases, the primer treatment layer can be 1 to 600 μm (about 1 to 600 μm) thick. The primer treatment layer can be 1 to 500 μm (about 1 to 500 μm), 1 to 200 μm (about 1 to 200 μm), 1 to 130 μm (about 1 to 130 μm), or 1 to 10 μm (about 1 to 10 μm) thick.

[0111] In some cases, the parylene layer can reduce the difference in surface conditions between the substrate and the electronic components, electronic connections, and / or electronic tracks.

[0112] FIG. 5 illustrates a coating 500 having a coating similar to the substrate described in FIGS. 2A - 2D. However, the coating 500 can include a primer treatment layer 522. As illustrated in the coating 500 of FIG. 5, the layer 522 of the primer treatment can be positioned on the side surface of the substrate facing the wound between the substrate 205 and the hard coat 214 and / or the soft coat 216. In some cases, the hard coat 214 can be optional, and the soft coat 216 can be applied directly on top of the primer treatment layer 522 positioned on a part or the whole of the side surface of the substrate facing the wound. In some cases, the primer treatment layer can be applied to one or both of the side surface of the substrate facing the wound or the side surface not facing the wound.

[0113] The application of a coating to a substrate may leave gaps due to features. For example, if the coating is applied at different heights of electronic components, electrical connections, and / or electrical tracks on the substrate, gaps may be left during coating application. Further, due to the liquid phase of the coating, the coating may have valleys and peaks that create different depths in the coating thickness. In some cases, the coating thickness can be increased to reduce the potential for gaps to form. Alternatively or additionally, multiple passes of applying the coating at a reduced thickness can be used to achieve the same end thickness. For example, the coating can be applied in two or more passes. In some cases, the coating can be applied in two or more passes, each at 65 microns, to achieve a coating thickness of 130 microns.

[0114] In some cases, the passes can be run in various directions to reduce the likelihood of gaps formed at low points / valleys or different depths of features. For example, layer 2 can be applied across layer 1. FIGS. 6A - 6C illustrate embodiments of multiple passes of a coating in various directions for use on a wound dressing. In some cases, the coating may be a soft coat as described with reference to FIGS. 2A - 2D and FIG. 5.

[0115] FIG. 6A illustrates a first layer 632 applying a coating in a first direction. Each coating application or layer can be applied in a sinusoidal pattern as indicated by the arrows in FIGS. 6A - 6C. In other cases, each coating layer or application can be applied in a parallel direction. A second layer 634 of the coating can be applied in a second direction (e.g., a direction transverse to the first layer) as shown in FIG. 6B. FIG. 6C illustrates a second layer 634 applied in a transverse direction over the first layer 632. For example, as illustrated in FIGS. 6A - 6C, the first layer 632 can be applied horizontally and the second layer 634 can be applied vertically.

[0116] In other cases, multiple layers of coating can be applied in the same direction, but these layers can be appropriately offset to cover different depths or valleys created by applying the coating. For example, layer 1 can have a step size of 4 mm, layer 2 can be applied with a step size of 4 mm, but can be offset by 2 mm such that the apex of layer 1 fills the valley of layer 2. In some cases, subsequent layers can be applied after curing of the first layer or prior to any curing of the first layer (e.g., the layers can be stacked in a liquid form).

[0117] Figures 7A - 7D illustrate embodiments of multiple passes of a coating in the same direction with an offset applied for use on a wound dressing. Figure 7A illustrates the application of a first layer 732 of the coating in a first direction, and Figure 7B illustrates the application of a second layer 734 in the same direction as the first direction in which the first layer was applied. The application or layer of each coating can be applied in a sinusoidal pattern as indicated by the arrows in Figures 7A - 7C. In other cases, the layer or application of each coating can be applied in a parallel direction. Figure 7C illustrates a second layer 734 applied offset on top of the first layer 732 in the same direction. Figure 7D illustrates a cross - section of the first layer 732 and the second layer 734 applied on a substrate 700. The cross - section illustrates the valleys and peaks created by each pass of the layer when applied to the substrate. As illustrated in Figure 7D, the second layer 734 is offset from the first layer 732 such that the peaks of the first layer 732 align with the valleys of the second layer 734. Figure 7D shows that the first and second layers are offset such that the peaks of one layer align with the valleys of the other layer, but the layers can be offset by any amount to apply more coverage to each area, and it is not necessary for each peak of the first layer to align with each valley of the second layer. Multiple passes of the coating can produce a more uniform coating than the application of a single coating applied to the substrate. In some cases, multiple passes of a soft coat can be applied to the substrate on the side facing the wound and / or the side not facing the wound. In some cases, multiple passes of a soft coat can be used instead of or in addition to a hard coat. When multiple passes of a coating are applied to a substrate, different layers can have different thicknesses. For example, the second layer may not be thicker than the first layer, or the first layer may not be thicker than the second layer.

[0118] In some cases, the soft coat may be applied to one or more layers having various thicknesses on the substrate surface. For example, the soft coat may have a thinner first region applied over the electronic components and / or electrical connections, or over a second region applied over the hard coat and the remaining portion of the substrate surface. For example, as illustrated in FIG. 8A, a first coat 814 may be applied over the electronic components and / or electrical connectors. The first coat 814 may be the hard coat described herein. A second coat 816 may be applied over the substrate 800 and / or the first coat 814 with various thicknesses. The second coat 816 may be the soft coating described herein. The second coat 816 may be applied with a thinner layer of the second coat positioned over the first coat 814 and a thicker layer of the second coat 816 applied over the remaining portion of the substrate surface. In other cases, the soft coat may have a uniform or substantially homogeneous thickness of the second coat 816 applied over the substrate 800, as illustrated in FIG. 8B. FIG. 8C illustrates a substrate including a first coat 814 applied over the electronic components and / or electrical connectors of the substrate. As illustrated in FIG. 8C, the second coat 816 can be applied over the substrate 800, but a portion or all of the first coat 814 is not covered.

[0119] Shape and Positioning of the Coating The coating is applied over various components of the substrate. In such cases, it may be important to consider the shape or thickness of the coating in order to enable the substrate and components to function properly. For example, on an optical sensor, the coating may form a lens-like material for the light-emitting and light-receiving elements of the electronic component. Thus, the bulk shape, surface angle, surface finish, refractive index, and / or transparency of the coat may be considered. Further, artifacts such as entrapped air or other foreign inclusions that can scatter light may also be considered. On a thermal sensor, the coating may form an object of a given thermal mass. The effects of artifacts such as the bulk shape, surface finish, thermal contact with the wound, the behavior of heat transfer, and / or entrapped air of the coating system can be considered. The shape of the coating can be varied to account for some of these properties and provide an optimal or preferred environment for using a particular sensor.

[0120] In some cases, the coating may be applied in a shape that approximates the components and / or connectors on the substrate. FIG. 9A illustrates a first coating 914 (such as a hard coat) applied over an electronic component and / or connector 902 on a substrate 900. As illustrated in FIG. 9A, the first coating 914 may have a shape that approximates the contour of the electronic component and / or connector 902 on the substrate 900.

[0121] In some cases, the coating may have a contour that approximates a fixed gradient so as to provide appropriate properties to the components or sensors on the substrate. For example, the coating may approximate a lens or polymer of a consistent thermal mass. FIG. 9B illustrates a substrate 900 having an electronic component and / or connector 902. The electronic component and / or connector 902 may be covered by a first coating 914 (such as a hard coat). The first coating 914 may be shaped to approximate a fixed gradient (such as a dome shape) so as to meet the desired properties.

[0122] Figures 9A and 9B illustrate a second coating 916 applied over a substrate 900 and a first coating 914. Figures 9A and 9B illustrate a first coating 914 applied over an electronic component and / or connector 902, and a second coating 916 applied over the entire surface of the substrate 900, including over the first coating 914. In some cases, the first coating 914 may be a hard coat or a soft coat as described herein. In some cases, the second coating 916 may be a hard coat or a soft coat as described herein. Figures 9A and 9B illustrate both a first coating and a second coating applied to a substrate, although it is understood that only the first coating may be used and the second coating is optional. In other cases, the first coating may be optional and only the second coating is used. In such cases, the second coating can be shaped as described with respect to the first coating in Figures 9A and 9B, but can cover the entire surface or substantially the entire surface of the substrate 900.

[0123] The coating applied over an impedance sensor can have a defined capacitance and thickness that can take into account the functionality of the sensor during use. In some cases, as shown in Figure 10A, the coating 1014 can be applied in multiple passes over the impedance sensor or any other sensor 1002 to ensure that there are no gaps within the coverage of the coating.

[0124] Coat homogeneity and close contact with the wound may be important. The effects of artifacts such as entrained air can be considered. In some cases, it may be useful not to apply the first coating or a non-stretchable coating on the side of the impedance sensor facing the wound. However, it may also be advantageous to avoid stretching or deformation of the impedance pad during reading of the wound. Thus, as shown in FIG. 10B, the first coating 1014 can be applied to the side of the substrate 1000 that does not face the wound. The first coating 1014 can be applied to the side of the substrate 1000 that does not face the wound, opposite the location of the component 1002 (such as an impedance sensor or other component) on the side of the substrate facing the wound. The first coating may be a non-stretchable coating and can be used to prevent stretching and reduce stretching of the impedance pad to enable consistent readings. The second coating 1016 can be applied to the side of the substrate facing the wound. The third coating 1010 can be applied to the side of the substrate that does not face the wound and is layered on top of the first coating 1014 in some regions. Application of the first coating to the side of the substrate that does not face the wound can be used for a wide range of sensors that have the advantage of not applying the first coating directly to the component. The second coating 1016 (such as a soft coat) can be applied on top of the component 1002 on the side of the substrate 1000 facing the wound. As shown in FIG. 10B, the third coating 1010 can be applied on top of the side of the substrate 1000 that does not face the wound and can cover the first coating 1014.

[0125] In some cases, the first coat can be applied in various patterns, shapes, or application configurations to prevent local stretching or contraction of the film beneath the component when the first coat (non - stretchable coating) is applied to the side of the substrate facing away from the wound. As shown in FIGS. 10C - 10F, various shapes, patterns, or configurations of the first coating can be applied to the side of the substrate facing away from the wound. In some cases, as shown in FIG. 10E, the first coating on the side of the substrate facing away from the wound can cover most or all of the footprint of the component. In some cases, the first coating on the side of the substrate facing away from the wound can cover the outer perimeter of the footprint of the component as shown in FIG. 10E, or can cover an area outside the outer perimeter of the footprint of the component as shown in FIG. 10C. In some cases, the first coating on the side of the substrate facing away from the wound can cover the footprint of the component in a design, such as a hash pattern as shown in FIG. 10D, or any other design that reduces stretching or contraction.

[0126] When positioned over other components forming an electrical circuit, the coating can form an object with a given thermal mass. Any thermal effects that can interfere with the performance of the system, such as heating of the components, or that can affect the patient, can be considered.

[0127] Optional coating As described herein, the coating (e.g., soft coat) may be a hydrophilic material. For example, the soft coat may be an acrylated urethane. The coating may be a biocompatible coating. Other materials can be used for the coating to provide the necessary properties for the substrate and to utilize sensors or other components. In some cases, silicone materials can be used in addition to or in place of one or more coatings. For example, RTV-2 silicone or similar materials can be used to cover or encapsulate electronic components, connectors, and / or tracks. In such cases, the silicone material can be applied to the surface facing the wound of the substrate and / or the surface not facing the wound. In some cases, a first coating (such as the hard coat or soft coat material described herein) can be applied to the side surface of the substrate facing the wound in the area of the substrate that supports the electronic component and / or the electronic connector. Then, the remaining portion of the substrate and the first coating can be covered or coated with a silicone material coating. In such cases, the silicone material can be used as the second coating 216 described with reference to FIGS. 2A-2D. The covering material including the substrate and the silicone material can be perforated as described herein.

[0128] The silicone material can be applied to one side of the substrate, and the substrate and the silicone material can be perforated. A second silicone material can be applied to the second side of the substrate, and the coating can be perforated again. In some cases, a two-step perforation process may be able to cover or encapsulate the inner wall of the perforation with the silicone material. A similar process is described in UK Patent Application No. 1918856.4, entitled "SENSOR INTEGRATED DRESSINGS AND SYSTEMS", dated December 19, 2019, which is incorporated herein by reference in its entirety. In some cases, the substrate can be laminated onto both the side facing the wound and the side not facing the wound using an adhesive material such as an adhesive film or sheet. The film or sheet of the adhesive material may be an impermeable, stretchable, and flexible material.

[0129] In some cases, different materials can be used for the various coatings, such that different properties of the coatings can be used in combination with the substrate and components. For example, referring to FIGS. 2A - 2D, a first coating 214 can be provided over the electronic components or connectors of the substrate, and a second coat 216 can be provided over the side of the substrate facing the wound and over the first coating 214. An additional third coating 219 can be provided over the side of the substrate not facing the wound.

[0130] In some cases, the first coating and the second coating may be the same material. For example, a soft coating can be used as the first coating to cover the electronic components and / or connectors, and the same soft coating material can be used as the second coating to cover the side of the substrate facing the wound, including covering the first coating. By using the soft coat material or a compatible coat material described herein for both the first coating and the second coating, it may be possible to increase the stretch and shrink of the coating while still enabling the electronic components and connections to function under stretched and shrunk conditions.

[0131] In some cases, the order of application of the first coating and the second coating can be reversed. For example, the second coating can be applied over the entire side of the substrate facing the wound, and then the first coating can be applied to the side of the substrate facing the wound in the area of the substrate that supports the electronic component and / or the electrical connection. This can provide a thicker coating over the electronic component and / or connection. If the coating materials used for the second coating and the first coating are the same material, then the area of the substrate that supports the electronic component and / or the electrical connection may have an additional layer of coating that provides better protection from the wound for these areas.

[0132] In some cases, the first coating and the second coating can be cured separately if the curing process occurs between each application of the coating layer. In other cases, the first coating and the second coating can be cured together after both coats have been applied to the side of the substrate facing the wound. In these cases, since the coating cures together, the coating may appear as one coating with a thicker layer of localized coating over the area having the electronic component and / or the electrical connection. This is particularly true when the first coating and the second coating utilize the same material. In such cases, the first coating and the second coating can be considered as one coating within the final product having a thicker, reinforced area over the electronic component and / or the electrical connection. In such cases, the first coating may be stretchable or substantially stretchable if the first coating uses a conformable coat or soft coat material as described herein. However, in some cases, the area having the thicker double coating may be less stretchable than the area of the substrate having only a thin layer of coating applied over the entire surface facing the wound.

[0133] In some cases, instead of the first coating and the second coating being applied to the side of the substrate facing the wound, only one layer of coating may be applied to the side of the substrate facing the wound. In such cases, it may be necessary to apply a thicker single coating over the entire surface of the substrate as compared to the thickness of the second coating applied during the two - coating application process. Thus, in some cases, the single layer of coating may be thicker and, consequently, less stretchable than the coating over the entire coating material applied by the two - coating processes. For example, the single layer of coating may have a thickness of 10 - 600 μm (about 10 - 600 μm). The single layer of coating may have a thickness of 10 - 1200 μm (about 10 - 1200 μm).

[0134] In some cases, a fourth coating may be applied to the side of the substrate facing the wound to support the electronic component and / or the electronic connector and reinforce or further protect the area or region of the substrate where the electronic component and / or the electronic connector is located. In some cases, one or more of the first coating 214, the second coating 216, the third coating 210, and the fourth coating (not shown) may be of the same material. In such cases, one or more of the first coating 214, the second coating 216, the third coating 210, and the fourth coating may be a compatible coat or soft coat as described herein.

[0135] In some cases, one or more of the first coating 214, the second coating 216, the third coating 210, and the fourth coating (not shown) may not be stretchable but may be flexible. For example, a layer of parylene C can be used to cover the substrate. In such cases, the parylene C layer may have a thickness of several microns, for example, a thickness of 1 to 10 microns. In some cases, the layer of parylene C may have a thickness of 1 to 600 μm (about 1 to 600 μm). The primer treatment layer may have a thickness of 1 to 500 μm (about 1 to 500 μm), 1 to 200 μm (about 1 to 200 μm), 1 to 130 μm (about 1 to 130 μm), or 1 to 10 μm (about 1 to 10 μm). The parylene C layer can maintain the flexibility of the substrate, but in some cases, it can reduce the extensibility or stretchability. In some cases, parylene C can be used as described herein with reference to the primer treatment on the substrate.

[0136] In some cases, one or more of the first coating 214, the second coating 216, the third coating 210, and the fourth coating (not shown), or any of the coatings described herein, may be optically clear, transparent, and / or colorless.

[0137] Wicking of Coating Materials It may be useful to utilize a wicking layer or wicking material on the side of the substrate described herein that faces away from the wound, with reference to FIGS. 2A and 2B. In other cases, a coating (e.g., a third coating 210) on the side of the substrate that faces away from the wound may be a hydrophilic material that can draw liquid from the wound through the substrate to any additional coating or coating layer used in combination with the substrate. The third coating may have a substrate contact side and an opposite non-substrate contact side. To provide a wicking action through the substrate, the third coating may be a material that isolates the liquid and protects the side of the substrate that faces away from the wound as described herein with reference to the third coating 210. However, the outer surface or non-substrate contact side of the third coating may be hydrophilic to draw fluid through the coating. In some cases, this may be achieved by using a material for the third coating with a modified surface property.

[0138] In other cases, this may be achieved with a two-coating system applied to the side of the substrate that faces away from the wound, as shown in FIG. 11. FIG. 11 may be similar to FIGS. 2C and 2D, but FIG. 11 uses an additional coating on the side of the substrate that faces away from the wound. The additional coating 222 may be applied over the third coating 210. The third coating 210 described herein can be applied directly to the substrate 205. The third coating may be covered by an additional coating 222 that may be a hydrophilic material that provides a wicking system for drawing fluid through perforations in the substrate.

[0139] In some cases, the first coating 214 and the second coating 216 can be applied to the side surface of the substrate 205 facing the wound, and then the substrate can be perforated 230. Then, the third coating 210 can be applied to the side surface of the substrate not facing the wound. In some cases, the inner wall of the perforation is coated by the coating material in a liquid state flowing through the perforation, so that the inner wall of the perforation can be coated through the application of the third coating. Thereby, encapsulation of the substrate can be provided by covering or coating the inner wall of the perforation. The third coat can cure before applying any additional layers. In some cases, this encapsulation may be an encapsulation of a hydrophobic material. The coating of the inner wall of the perforation is described in more detail in UK Patent Application No. 1918856.4, entitled "SENSOR INTEGRATED DRESSINGS AND SYSTEMS", dated December 19, 2019, which is incorporated herein by reference in its entirety. An additional hydrophilic coating 222 can be applied over the third coating 210 on the side of the substrate 205 not facing the wound and flow into the perforation 230, and thereby an additional coating can also be applied over the inner wall of the perforation using the hydrophilic coating. Thereby, a perforation with an inner wall can be created that is encapsulated with a hydrophobic coating and then treated with an additional hydrophilic coating to facilitate the transfer of fluid through the perforation to the side of the substrate not facing the wound.

[0140] In some cases, the coated substrate can be encapsulated with a silicone layer formed from a silicone material. The silicone layer may be an additional coating layer over the substrate and / or over any coating on the substrate. In some cases, the silicone layer may be the outermost layer of the coated substrate.

[0141] The additional silicone layer can be applied to the side of the coated substrate facing the wound and / or the side not facing the wound. In some cases, the additional coating can be used in place of or in addition to any of the coatings described herein. The silicone layer can be used in combination with any combination of the coatings described herein. For example, the silicone layer can be applied over the second and third coatings described herein, thereby encapsulating the coated substrate with the silicone material. In other cases, only one side of the substrate can be coated with the silicone layer. The substrate can be perforated before or after any of the coatings are applied, including before or after the silicone layer is applied. In some cases, the silicone layer can provide a barrier against water and moisture to protect electronic devices on the substrate.

[0142] As used herein, after each application of a coating material or coating layer, a curing step of curing the coating material or coating layer may follow. In other cases, as used herein, the coating material and coating layer need not be cured during each application of the coating, and the coating material or coating layer can be cured after all layers are applied or during any application of any coating material or coating layer.

[0143] In some cases, each of one or more of the coatings described herein may have a thickness of 10 to 600 μm (about 10 to 600 μm). Each of one or more of the coatings may have a thickness of 10 to 500 μm (about 10 to 500 μm), 10 to 200 μm (about 10 to 200 μm), or 18 to 130 μm (about 18 to 130 μm). Each of one or more coatings may have a thickness of 135 μm (about 135 μm). In some cases, one or more coatings may include a combined thickness of 10 to 600 μm (about 10 to 600 μm). One or more of the coatings may have a combined thickness of 10 to 500 μm (about 10 to 500 μm), 10 to 200 μm (about 10 to 200 μm), or 18 to 130 μm (about 18 to 130 μm). One or more of the coatings may have a combined thickness of 135 μm (about 135 μm).

[0144] In some cases, the coatings or layers described herein may have a uniform or homogeneous thickness (or substantially uniform or homogeneous thickness) on a substrate, including on an electronic component, an electronic connection, and / or an electronic track.

[0145] In some cases, a single coating or layer described herein can be used and applied at various thicknesses. Due to the non-uniform thickness of the coating, a greater thickness may be applied on an electronic component and / or an electronic connector, while a thinner layer of the same or a different coating can be applied to the rest of the substrate. The non-uniform thickness of the coating can be created using multiple layers of the applied material, multiple passes for the application of the coating, and / or a single coating pass that applies coatings of various thicknesses to dispersed areas on the substrate and / or on an electronic component and / or an electronic connector.

[0146] Other variations In some cases, one or more electronic components may be positioned on a side surface of the substrate opposite the side surface facing the wound. The systems and methods described herein are equally applicable to such a wound contact layer. The specific embodiments described herein relate to a wound dressing, but the systems and methods disclosed herein are not limited to wound dressings or medical applications. The systems and methods disclosed herein are generally applicable to electronic devices in general, such as electronic devices that can be worn by a user or applied to a user.

[0147] Any values provided herein, such as threshold values, limit values, periods, etc., are not intended to be absolute values and may, therefore, be approximate values. Additionally, any threshold values, limit values, periods, etc. provided herein may be fixed or variable, either automatically or by the user. Further, as used herein, terms representing relative degrees such as above, exceeding, less than, etc., in relation to a reference value are intended to include cases where they are equal to the reference value. For example, exceeding a positive reference value can include being equal to or greater than the reference value. Additionally, as used herein, terms representing relative degrees such as above, exceeding, less than, etc., in relation to a reference value are intended to include the opposite of the disclosed relationships such as below, less than, exceeding, etc., in relation to the reference value. Further, although various process blocks may be described with respect to determining whether a value reaches or does not reach a particular threshold value, the blocks may be understood similarly, for example, with respect to whether a value is (i) less than or exceeding the threshold value, or (ii) meeting or not meeting the threshold value.

[0148] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example are to be understood as applicable to any other aspect, embodiment, or example described herein, unless they are incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The subject matter is not limited to the details of any of the foregoing embodiments. The subject matter extends to any novel one, or any novel combination, of the features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0149] While specific embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in various other forms. Further, various omissions, substitutions, and changes can be made in the forms of the methods and systems described herein. Those skilled in the art will understand that in some cases, the actual steps implemented in the exemplified or disclosed processes may differ from those shown in the drawings. Depending on the embodiment, certain of the above-described steps may be excluded, or others may be added. For example, the actual steps or the order of steps implemented in the disclosed process may differ from those shown in the drawings. Depending on the embodiment, certain of the above-described steps may be excluded, or others may be added. For example, the various components illustrated in the drawings may be implemented as software or firmware on a processor, a controller, an ASIC, an FPGA, or dedicated hardware. Hardware components such as controllers, processors, ASICs, FPGAs, and the like may include logic circuits. Further, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0150] The present disclosure includes specific embodiments, examples, and applications, but the present disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses and their obvious modifications and their equivalents, and includes embodiments that do not necessarily provide all of the features and advantages described herein. It will be understood by those skilled in the art that the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein and may be defined by the claims presented herein or presented hereafter.

[0151] Conditional phrases such as "can," "could," "might," or "may," unless specifically described otherwise or interpreted otherwise within the context in which they are used, typically convey that a particular embodiment includes a particular feature, element, or step while other embodiments do not. Thus, such conditional phrases generally do not imply that a feature, element, or step is required in any way in one or more embodiments, or that logic for determining whether these features, elements, or steps are included in any particular embodiment, or are to be performed in any particular embodiment, regardless of user input or instructions, is necessarily included in one or more embodiments. Terms such as "comprises," "includes," and "has" are synonyms and are used inclusively and in an open-ended fashion, and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive sense (not an exclusive sense), so that, for example, when used to connect a listing of elements, the term "or" means one, some, or all of the elements in the listing. Further, the term "each," as used herein, in addition to having its ordinary meaning, may also mean any subset of a series of elements to which the term "each" applies.

[0152] Conjunctive phrases such as the phrase "at least one of X, Y, and Z," unless specifically described otherwise, are to be interpreted otherwise depending on the context in which they are used, which is generally used to suggest that an item, term, etc. can be any of X, Y, or Z. Thus, such conjunctive phrases do not necessarily imply that a particular embodiment requires inclusion of at least one X, at least one Y, and at least one Z.

[0153] As used herein, terms such as "about," "approximately," "generally," and "substantially," and other expressions of degree used herein, represent values, amounts, or characteristics that are close to a given value, amount, or characteristic that still perform the desired function or yield the desired result. For example, the terms "about," "approximately," "generally," and "substantially" may refer to amounts that are within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given amount.

[0154] The scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims presented in this section or elsewhere in this specification, or presented hereafter. The language of the claims should be interpreted in a broad sense based on the language used in the claims, and should not be limited to the examples described in this specification or in the course of the procedure of this application. Those examples should be construed as non-exclusive. [Additional item 1] A method for coating a wound dressing material, the method comprising: applying a first coating on a first side of a substantially flexible substrate of the wound dressing material, the first side of the substrate supporting a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and applying the first coating to at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce the at least one connector or the at least one electronic component; applying a second coating on the first side of the substrate, the second coating comprising a first layer and a second layer, the first layer being applied in a first direction and the second layer being applied in a second direction transverse to the first direction; coating a second side of the substrate, opposite to the first side, with a third coating. [Additional item 2] The method according to any one of the preceding claims, further comprising coating at least some of the plurality of electronic components with a fourth coating. [Additional item 3] The method according to any one of the preceding claims, further comprising a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. [Additional item 4] The method according to any one of the preceding claims, wherein the third coating comprises the same material as the second coating applied to the first side of the substrate. [Additional item 5] The method according to any one of the preceding claims, wherein the third coating comprises a material different from that of the second coating applied to the first side of the substrate. [Additional item 6] The method according to any one of the preceding claims, wherein the plurality of electronic components comprises a plurality of sensors configured to obtain a measurement value of the wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections. [Appended Claim 7] A method for coating a wound dressing material, the method comprising: applying a first coating on a first side of a substantially flexible substrate of the wound dressing material, the first side of the substrate supporting a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and applying the first coating to at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce the at least one connector or the at least one electronic component; applying a second coating on the first side of the substrate, the second coating comprising a first layer and a second layer, the first layer being applied in a first direction, the second layer being applied in a second direction parallel to the first direction, and the first layer being offset from the second layer; coating a second side of the substrate, opposite the first side, with a third coating. [Appended Claim 8] The method according to claim 7, further comprising coating at least some of the plurality of electronic components with a fourth coating. [Appended Claim 9] The method according to claim 7 or 8, further comprising a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. [Appended Claim 10] The method according to any one of claims 7 to 9, wherein the third coating comprises the same material as the second coating applied to the first side of the substrate. [Appended Claim 11] The method according to any one of claims 7 to 10, wherein the third coating comprises a material different from that of the second coating applied to the first side of the substrate. [Appended Claim 12] The method according to any one of appended claims 7 to 11, wherein the plurality of electronic components include a plurality of sensors configured to obtain a measurement value of the wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections. [Appended claim 13] A method for coating a wound dressing material, the method comprising: applying a primer treatment layer to a first side of a substantially flexible substrate of the wound dressing material; applying a first coating on the primer treatment layer on the first side of the substantially flexible substrate of the wound dressing material, wherein the first side of the substrate supports a plurality of electronic components, electrical tracks, and a plurality of connectors between the electronic components and the electrical tracks, and applying the first coating to at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce the at least one connector or the at least one electronic component; applying a second coating on the first side of the substrate; coating a second side of the substrate, opposite to the first side, with a third coating. [Appended claim 14] The method according to appended claim 13, further comprising applying a second primer treatment layer to the second side of the substrate before applying the third coating. [Appended claim 15] The method according to appended claim 13 or 14, wherein the first primer treatment layer or the second primer treatment layer comprises parylene. [Appended claim 16] The method according to appended claim 13 or 14, wherein the first primer treatment layer or the second primer treatment layer comprises parylene C. [Appended claim 17] The method according to any one of appended claims 13 to 16, further comprising coating at least some of the plurality of electronic components with a fourth coating. [Appended claim 18] The method according to any one of appended claims 13 to 17, further comprising a plurality of through holes formed through the second coating and the substrate, the plurality of through holes being configured to facilitate the passage of fluid. [Appended claim 19] The method according to any one of appended claims 13 to 18, wherein the third coating comprises the same material as the second coating applied to the first side of the substrate. [Appended claim 20] The method according to any one of appended claims 13 to 19, wherein the third coating comprises a material different from that of the second coating applied to the first side of the substrate. [Appended claim 21] The method according to any one of appended claims 13 to 20, wherein the plurality of electronic components comprise a plurality of sensors configured to acquire measurement values of the wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections. [Appended claim 22] A wound dressing device, A substantially flexible substrate comprising a first side of the substrate that supports a plurality of electronic components, electrical tracks, and a plurality of connectors between the electronic components and the electrical tracks; A primer treatment layer on the first side of the substantially flexible substrate of the wound dressing; A first coating on the first side of the substrate that is applied over the primer treatment layer and over an area of at least one of the plurality of connectors or over at least one of the plurality of electronic components to reinforce the at least one connector or the at least one electronic component; A second coating on the first side of the substrate; A wound dressing device comprising a third coating on a second side of the substrate, opposite the first side. [Appended claim 23] The dressing according to appended claim 22, further comprising a second primer treatment layer, the second primer treatment layer being applied to the second side of the substrate between the substrate and the third coating. [Appended claim 24] The dressing according to appended claim 22 or 23, wherein the first primer treatment layer or the second primer treatment layer comprises parylene. [Appended claim 25] The dressing according to any one of appended claims 22 to 24, wherein the first primer treatment layer or the second primer treatment layer comprises parylene C. [Appended claim 26] The dressing according to any one of appended claims 22 to 25, further comprising at least some of the plurality of electronic components coated with a fourth coating. [Appended claim 27] The dressing according to any one of appended claims 22 to 26, further comprising a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid. [Appended claim 28] The coating material according to any one of appended claims 22 to 27, wherein the third coating contains the same material as that of the second coating on the first side of the base material. [Appended claim 29] The coating material according to any one of appended claims 22 to 28, wherein the third coating contains a material different from that of the second coating on the first side of the base material. [Appended claim 30] The coating material according to any one of appended claims 22 to 29, wherein the plurality of electronic components includes a plurality of sensors configured to acquire measurement values of the wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections. [Appended claim 31] A method as illustrated and / or described. [Appended claim 32] A wound dressing as illustrated and / or described. [Appended claim 33] A kit comprising a wound dressing as illustrated and / or described and a negative pressure wound therapy device.

Claims

1. A method for coating a wound dressing, the method comprising: applying a first coating on a first side of a substantially flexible substrate of the wound dressing, the first side of the substrate supporting a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and applying the first coating to at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce at least one of the connectors or at least one of the electronic components; applying a second coating on the first side of the substrate, the second coating comprising a first layer and a second layer, the first layer being applied in a first direction and the second layer being applied in a second direction transverse to the first direction; coating a second side of the substrate, opposite the first side, with a third coating; A method comprising.

2. The method of claim 1, further comprising coating at least some of the plurality of electronic components with a fourth coating.

3. The method according to claim 1 or 2, further comprising a plurality of perforations formed through the second coating and the substrate, the plurality of perforations being configured to facilitate the passage of fluid.

4. The method according to any one of claims 1 to 3, wherein the third coating comprises the same material as the second coating applied to the first side of the substrate.

5. The method according to any one of claims 1 to 4, wherein the third coating comprises a material different from that of the second coating applied to the first side of the substrate.

6. The method according to any one of claims 1 to 5, wherein the plurality of electronic components comprise a plurality of sensors configured to obtain measurements of a wound, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections.

7. A method for coating a wound dressing, the method comprising: applying a first primer treatment layer to a first side of a substantially flexible substrate of the wound dressing; Applying a first coating over the first primer treatment layer on the first side of the substantially flexible substrate of the wound dressing material, wherein the first side of the substrate supports a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, and applying the first coating to at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce at least one of the connectors or at least one of the electronic components; Applying a second coating on the first side of the substrate; Coating a second side of the substrate, opposite the first side, with a third coating; A method comprising. **Claim 8** The method according to claim 7, further comprising applying a second primer treatment layer to the second side of the substrate before applying the third coating. **Claim 9** The method according to claim 8, wherein the first primer treatment layer or the second primer treatment layer comprises parylene. **Claim 10** The method according to claim 8, wherein the first primer treatment layer or the second primer treatment layer comprises parylene C. **Claim 11** A wound dressing material device, A flexible substrate that supports a plurality of electronic components, electronic tracks, and a plurality of connectors between the electronic components and the electronic tracks, the substrate having a first side; A first primer treatment layer on the first side of the substantially flexible substrate of the wound dressing material; A first coating on the first side of the substrate, applied over the first primer treatment layer and over an area of at least one of the plurality of connectors or at least one of the plurality of electronic components to reinforce at least one of the connectors or at least one of the electronic components; A second coating on the first side of the substrate; A third coating on a second side of the substrate, opposite the first side; A wound dressing material device comprising. **Claim 12** The dressing material device according to claim 11, further comprising a second primer treatment layer, the second primer treatment layer being applied to the second side of the substrate between the substrate and the third coating. **Claim 13** The coating material device according to claim 12, wherein the first primer treatment layer or the second primer treatment layer contains parylene.

14. The coating material device according to claim 12, wherein the first primer treatment layer or the second primer treatment layer contains parylene C.

15. The coating material device according to any one of claims 11 to 14, further comprising at least some of the plurality of electronic components coated with a fourth coating.

16. The coating material device according to any one of claims 11 to 15, further comprising a plurality of perforations formed through the second coating and the base material, the plurality of perforations being configured to facilitate the passage of fluid.

17. The coating material device according to any one of claims 11 to 16, wherein the plurality of electronic components include a plurality of sensors configured to acquire measurement values of wounds, and at least some of the plurality of sensors are interconnected by a plurality of electrical connections.

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