Sensor-integrated covering material and system

Abstract

In some cases, the wound dressing comprises a substantially flexible substrate having a first surface facing the wound that supports a plurality of electronic components and a second surface opposite the first surface, the substrate including a plurality of perforations formed therethrough, the plurality of perforations having walls on outer surfaces of the plurality of perforations; a first substantially stretchable coating applied to the first surface of the substrate; and a second substantially stretchable coating applied to the second surface of the substrate, the walls of the plurality of perforations being at least partially coated with at least one of the coatings.

Description

[Technical field]

[0001] Embodiments of the present disclosure relate to devices, systems, and methods for monitoring and / or treating tissue using sensor-integrated or sensor-enabled dressings. [Background technology]

[0002] Nearly every area of ​​medicine can benefit from improved information about the condition of the tissue, organ, or system being treated, especially if such information is collected in real time during treatment, and many types of treatments are still routinely performed without the use of sensor data collection. Instead, such treatments rely on visual inspection by a caregiver or other limited means, rather than quantitative sensor data. For example, in the case of wound treatment via dressings and / or negative pressure wound therapy, data collection is generally limited to visual inspection by a caregiver, and in many cases the underlying wound tissue may be obscured by a bandage or other visual obstruction. Even intact, unbroken skin may have underlying damage that is not visible to the naked eye, such as compromised blood vessels or deeper tissue damage that may lead to ulcers. As with wound treatment, during orthopedic treatments that require immobilization of a limb with a cast or other enclosure, only limited information about the underlying tissue is gathered. In the case of internal tissue repairs, such as bone plates, continuous direct sensor-driven data collection is not performed. Additionally, braces and / or sleeves used to support musculoskeletal function do not monitor underlying muscle function or limb movement. Outside of direct treatment, common hospital room supplies such as beds and blankets could be improved by adding the ability to monitor patient parameters.

[0003] Thus, 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

[0004] In some cases, the wound dressing comprises a substantially flexible substrate having a first surface facing the wound supporting a plurality of electronic components and a second surface opposite the first surface, the substrate comprising a plurality of perforations formed through the substrate, the plurality of perforations comprising walls on outer surfaces of the plurality of perforations; a first substantially elastic coating applied to the first surface of the substrate; and a second substantially elastic coating applied to the second surface of the substrate, the walls of the plurality of perforations being at least partially coated with at least one of the coatings.

[0005] The wound dressing of any of the above paragraphs and / or any of the wound dressings disclosed herein may include one or more of the following features: The walls of the plurality of perforations may be at least partially uniformly coated. The plurality of perforations may be 0.25 mm or greater in diameter. The walls of the plurality of perforations may include a plurality of grooves. The walls of the plurality of perforations may be at least partially non-uniformly coated. The dressing may further comprise a protective layer applied to the second side of the substrate, the protective layer may be configured to be removed to expose the substrate. The protective layer may include first and second portions separated by a slit, the first portion extending over the second portion and covering the slit. The plurality of electronic components may include a plurality of sensors configured to obtain measurements of the wound, at least some of the plurality of sensors being interconnected by a plurality of electronic connections. The first stretchable coating may cover substantially an entire area of ​​the first side of the substrate. The second stretchable coating may cover substantially an entire area of ​​the second side of the substrate. The first substantially stretchable coating and the second stretchable coating may comprise the same material. The walls of the plurality of perforations may be at least partially coated with the second stretchable coating. The covering material may further comprise a first substantially non-stretchable coating applied to at least some of the plurality of electronic components. The first substantially non-stretchable coating may be applied to at least some of the plurality of electronic components, and the first stretchable coating is applied over the substantially non-stretchable coating. An outer wall of a perforation of the plurality of perforations may have a first diameter, and a perforation of the plurality of perforations has a second diameter formed after at least one of the coatings is applied to the outer wall, the second diameter being within and less than the first diameter.

[0006] In some cases, the kit may include a dressing of any of the above paragraphs or any of the dressings disclosed herein and a negative pressure wound therapy device configured to provide negative pressure to a wound covered by the dressing.

[0007] The kits of any of the above paragraphs and / or any of the kits disclosed herein may include one or more of the following features: The dressings and negative pressure wound therapy device may be sterilized. The kits may further include a secondary dressing configured to be positioned over the dressing of any of the above paragraphs or any of the dressings disclosed herein.

[0008] In some cases, a method of manufacturing a wound dressing may include coating a wound-facing first side of a substantially flexible substrate with a first coating, the substrate including a second side opposite the first side, the first side of the substrate supporting a plurality of electronic components, the first coating being applied to at least some of the plurality of electronic components; perforating the substrate coated with the first coating to create a plurality of perforations through the substrate coated with the first coating, the plurality of perforations including walls, the plurality of perforations being configured to facilitate the passage of fluid through the substrate; and coating a second side of the substrate with a second coating, the second coating applied to the substrate being positioned on a surface including a plurality of pins extending through the plurality of perforations, the second coating being applied at least partially to the walls of the plurality of perforations.

[0009] The method of the above paragraph and / or any of the methods disclosed herein may include one or more of the following features: The plurality of pins are tapered or dome shaped. The method may further include collecting the second coating flowing under the pins in a gutter. Coating the second side of the substrate may include uniformly applying the second coating to walls of the plurality of perforations. The walls of the plurality of perforations may include grooves. Coating the second side of the substrate may include non-uniformly applying the second coating to walls of the plurality of perforations. The method may further include adhering a protective layer to the substrate, the protective layer may be configured to be removed to expose the substrate. The method may further include coating the first side with a third coating applied to at least some of the plurality of electronic components, the second coating being applied over the third coating.

[0010] In some cases, a method of manufacturing a wound dressing includes coating a wound-facing first side of a substantially flexible substrate with a first coating, the substrate including a second side opposite the first side, the first side of the substrate supporting a plurality of electronic components, the first coating being applied to at least some of the plurality of electronic components; perforating the substrate coated with the first coating to create a first plurality of perforations through the substrate coated with the first coating, the first plurality of perforations including a wall and having a first diameter; and coating the second side of the substrate with a first coating. The method may include coating with a second coating, where the second coating is applied to fill the plurality of perforations and cover the walls of the plurality of perforations; and perforating the substrate coated with the first coating and the second coating to create a second plurality of perforations through the first plurality of perforations in the substrate coated with the first coating and the second coating, where the second plurality of perforations has a second diameter, the second plurality of perforations configured to facilitate the passage of fluid through the substrate, the second diameter being within and smaller than the first diameter. [Brief description of the drawings]

[0011] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1A] 1 illustrates a perspective view of a substrate supporting electronic components. [Figure 1B] 1 illustrates a perspective view and a top view of a perforated substrate supporting electronic components. [Figure 1C] 1 illustrates a perspective view and a top view of a perforated substrate supporting electronic components. [Figure 2A] 1 illustrates a cross-section of a wound dressing. [Figure 2B] 1 illustrates a cross-section of a wound dressing. [Figure 3A] 1 illustrates a perspective view and a top view of a perforated substrate supporting an electronic component. [Figure 3B] 1 illustrates a perspective view and a top view of a perforated substrate supporting an electronic component. [Figure 4A] 1 illustrates an embodiment of an uncoated perforation in a substrate. [Figure 4B] 1 illustrates an embodiment of an uncoated perforation in a substrate. [Figure 4C] 1 illustrates the coated exterior surface of a perforation in a substrate. [Diagram 5] Illustrated are embodiments of a method for manufacturing a substrate. [Figure 6A] 1 illustrates an embodiment of a tool that can be used to keep the perforation open. [Figure 6B] 1 illustrates one embodiment of a perforated substrate positioned on a tool having pins extending through perforations in the substrate. [Figure 6C] 1 illustrates one embodiment of a substrate having perforations that is coated with a spray coating after perforations are created in the substrate. [Figure 7A] 1 shows an image of a substrate having perforations coated without the use of a tool with pins that prevent the coating material from closing off the perforations. [Figure 7B]1 shows an image of a substrate having perforations being coated while using a tool with pins to prevent the coating from closing up the perforations. [Figure 8A] 1 illustrates an embodiment of a substrate positioned on a tool having pins. [Figure 8B] 1 illustrates an embodiment of a substrate positioned on a tool having pins. [Figure 8C] 1 illustrates an embodiment of a substrate positioned on a tool having pins. [Figure 8D] 1 illustrates embodiments of different pin shapes that can be used. [Figure 8E] 1 illustrates embodiments of different pin shapes that can be used. [Figure 8F] 1 illustrates embodiments of different pin shapes that can be used. [Figure 8G] 1 illustrates an embodiment of a tool having a tapered pin. [Figure 8H] 1 illustrates an embodiment of a tool having a tapered pin. [Figure 8I] 1 illustrates an embodiment of a tool having a pin with a groove positioned at the base of the pin. [Figure 8J] 1 illustrates an embodiment of a tool having a pin with a groove positioned at the base of the pin. [Figure 9A] 1 illustrates an embodiment of a substrate having perforations and positioning markers, as well as perforations corresponding to reference pins. [Figure 9B] 1 illustrates an embodiment of a substrate having perforations and positioning markers, as well as perforations corresponding to reference pins. [Figure 10] 1 illustrates an embodiment of a tool base plate for use with a tool having pins. [Figure 11] Illustrated are embodiments of a conical pin with ridges or a truncated cone with grooves. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 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.

[0013] 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.

[0014] The sensor embodiments disclosed herein may be used in combination with clothing. Non-limiting examples of clothing for use with the sensor embodiments disclosed herein include shirts, pants, trousers, dresses, underwear, outerwear, gloves, shoes, hats, and other suitable clothing. In certain embodiments, the sensor embodiments disclosed herein may be welded or laminated to a particular garment. The sensor embodiments may be printed directly on the garment and / or embedded in the fabric. Breathable and printable materials such as microporous membranes may also be suitable.

[0015] The sensor embodiments disclosed herein may be incorporated into cushioning or bed pads, such as in hospital beds, to monitor patient characteristics, such as any of the characteristics disclosed herein. In certain embodiments, a disposable film containing such sensors may be placed over a hospital bed and removed / replaced as needed.

[0016] In some implementations, the sensor embodiments disclosed herein may incorporate energy harvesting such that the sensor embodiments are self-sustaining. For example, energy may be harvested from a thermal energy source, a kinetic energy source, a chemical gradient, or any suitable energy source.

[0017] The sensor embodiments disclosed herein may be utilized in rehabilitation devices and treatments, including sports medicine. For example, the sensor embodiments disclosed herein may be used in braces, sleeves, wraps, supports, and other suitable items. Similarly, the sensor embodiments disclosed herein may be incorporated into sporting goods, such as helmets, sleeves, and / or pads. For example, such sensor embodiments may be incorporated into protective helmets to monitor properties such as acceleration that may be useful in concussion diagnosis.

[0018] The sensor embodiments disclosed herein may be used in conjunction with a surgical device, for example, the NAVIO Surgical System by Smith & Nephew Inc. In some implementations, the sensor embodiments disclosed herein may communicate with such a surgical device to guide the placement of the surgical device. In some implementations, the sensor embodiments disclosed herein may monitor blood flow to or away from a potential surgical site, or confirm the absence of blood flow to a surgical site. Additional surgical data may be collected to assist in preventing scarring and monitor areas away from the affected area.

[0019] To further aid surgical techniques, the sensors disclosed herein may be incorporated into surgical drapes to provide information about tissues beneath the drape that may not be immediately visible to the naked eye. For example, a sensor-embedded flexible drape may have sensors strategically positioned to provide improved area-focused data collection. In certain implementations, the sensor embodiments disclosed herein may be incorporated into the boundaries or interior of the drape to create fencing that limits / controls the surgical theater.

[0020] The sensor embodiments disclosed herein may also be utilized for pre-operative evaluation. For example, such sensor embodiments may be used to gather information about potential surgical sites, such as by monitoring the skin and underlying tissue for potential incision sites. For example, perfusion levels or other suitable characteristics may be monitored at the surface of the skin and deeper in the tissue to assess whether an individual patient may be at risk for surgical complications. Sensor embodiments such as those disclosed herein may be used to assess the presence of microbial infection and provide indications for the use of antimicrobial agents. Additionally, sensor embodiments disclosed herein may gather additional information at deeper tissues, such as identifying pressure ulcer lesions and / or adipose tissue levels.

[0021] The sensor embodiments disclosed herein may be utilized for cardiovascular monitoring. For example, such sensor embodiments may be incorporated into a flexible cardiovascular monitor that may be placed against the skin to monitor characteristics of the cardiovascular system and communicate such information to another device and / or a caregiver. For example, such a device may monitor pulse rate, blood oxygenation, and / or cardiac electrical activity. Similarly, the sensor embodiments disclosed herein may be utilized for neurophysiological applications, such as monitoring electrical activity of neurons.

[0022] The sensor embodiments disclosed herein may be incorporated into implantable devices, such as implantable orthopedic implants, including flexible implants. Such sensor embodiments may be configured to gather information about the implant site and transmit this information to an external source. In some cases, an internal source may also provide power to such implants.

[0023] The sensor embodiments disclosed herein may also be utilized to monitor biochemical activity at or below the surface of the skin, such as lactose accumulation in muscle or sweat production on the surface of the skin. In some cases, other properties may be monitored, such as glucose concentration, urine concentration, tissue pressure, skin temperature, skin surface conductivity, skin surface resistivity, skin hydration, skin maceration, and / or skin tearing.

[0024] Sensor embodiments disclosed herein may be incorporated into ear, nose, and throat (ENT) applications. For example, such sensor embodiments may be utilized to monitor recovery from ENT-related procedures, such as wound monitoring in the sinus passages.

[0025] Sensor embodiments disclosed herein may include sensor printing techniques with encapsulation, such as encapsulation with a polymer film. Such films may be constructed using any of the polymers described herein, such as polyurethane. Encapsulation of sensor embodiments may provide waterproofing of the electronics as well as protection from local tissue, local fluids, and other sources of potential damage.

[0026] In certain embodiments, the sensors disclosed herein may be incorporated into an organ protection layer. Such a sensor-embedded organ protection layer may both protect the organ of interest and ensure that the organ protection layer is in place and provides protection. Additionally, the sensor-embedded organ protection layer may 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 may be used to monitor a transplanted organ, such as by monitoring the fat and muscle content of the organ. Additionally, the sensor-enabled organ protection layer may be used to monitor the organ during transplantation and after transplantation, such as during organ rehabilitation.

[0027] The sensor embodiments disclosed herein may be incorporated into the treatment of wounds (disclosed in more detail below) or a variety of other applications. Non-limiting examples of additional applications for the sensor embodiments disclosed herein include monitoring and treatment of 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.

[0028] wound therapy Some systems and methods disclosed herein relate to wound therapy for a human or animal body. Thus, any reference to a wound herein may refer to a wound on a human or animal body, and any reference to a body herein may refer to a human or animal body. Disclosed technology embodiments may relate to preventing or minimizing damage to physiological or biological tissues or treating damaged tissues (e.g., wounds as described herein), with or without reduced pressure, including, for example, negative pressure sources and wound dressing components and devices. The devices and components, including wound overlay and packing materials, or inner layers, if any, may be collectively referred to as a dressing. In some cases, wound dressings may be provided to be utilized without reduced pressure.

[0029] As used herein, the term "wound" may include injuries to living tissue that may be caused by a cut, blow, or other impact, typically an impact in which the skin is cut or broken. Wounds may be chronic or acute injuries. Acute wounds occur as a result of surgery or trauma. They progress through the stages of healing within a predictable time frame. Chronic wounds typically begin as acute wounds. Acute wounds may become chronic wounds when they do not follow the healing stages, resulting in prolonged recovery. It is believed that the transition from acute to chronic wounds may be due to the patient being immunocompromised.

[0030] Chronic wounds may include, for example, venous ulcers (such as those occurring in the legs), which account for the majority of chronic wounds and primarily affect the elderly, diabetic ulcers (e.g., foot or ankle ulcers), peripheral arterial disease, pressure ulcers, or epidermolysis bullosa (EB).

[0031] Examples of other wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sternotomy, fasciotomy, or other conditions, dehiscence wounds, acute wounds, chronic wounds, subacute wounds and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers.

[0032] Wounds may also include deep tissue injury, 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 for many years with terms such as purple pressure ulcer, aggravating ulcer, and bruises on bony prominences.

[0033] Wounds may also include tissues at risk of becoming wounds, as discussed herein. For example, tissues at risk may include tissues over bony prominences (at risk of deep tissue injury / damage) or pre-surgical tissues (e.g., knee tissues) that may have the potential to be amputated (e.g., joint replacement / surgical alteration / reconstruction).

[0034] Some systems and methods disclosed herein relate to methods of treating wounds using the techniques disclosed herein in combination with one or more of the following: progressive footwear, turning the patient, offloading (e.g., offloading diabetic foot ulcers), treatment of infection, systemics, antimicrobials, antibiotics, surgery, tissue removal, influencing blood flow, physical therapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, active ozone, antibiotics, antimicrobials, and the like.

[0035] Alternatively or additionally, wounds may be treated using traditional advanced wound care that is not assisted by the use of topical negative pressure (TNP) and / or applied negative pressure (which may also be referred to as non-negative pressure therapy).

[0036] Advanced wound care may include the use of absorbent dressings, occlusive dressings, the use of antimicrobial and / or debridement agents in wound dressings or supports, the use of pads (e.g., cushioning or compression therapy such as stockings or bandages), and the like.

[0037] In some cases, the wound dressing includes one or more absorbent layers, which may be foams or superabsorbents.

[0038] In some cases, the disclosed technology may be used with non-negative pressure dressings. A non-negative pressure wound dressing suitable for providing protection at a wound site may include an absorbent layer for absorbing wound exudate and a shielding element for at least partially shielding the visibility of the wound exudate absorbed by the absorbent layer during use. The shielding element may be partially translucent. The shielding element may be a masking layer.

[0039] In some cases, the non-negative pressure wound dressings disclosed herein include a wound contact layer, and the absorbent layer overlies the wound contact layer. The wound contact layer may carry an adhesive portion for forming a substantially fluid-tight seal on the wound.

[0040] In some cases, the wound dressings disclosed herein further comprise a layer of superabsorbent fibers, or viscose or polyester fibers.

[0041] 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).

[0042] In some cases, the foam may be an open cell foam or a closed cell foam, typically an open cell foam. The foam may be hydrophilic.

[0043] The wound dressing may include a transmission layer, which may be a foam. The transmission layer may be a polyurethane foam laminated to a polyurethane film.

[0044] The non-negative pressure wound dressing may be a compression bandage. Compression bandages are known for use in treating edema and other venous and lymphatic diseases, for example, in the lower extremities. In some cases, the compression bandage may comprise a dressing system including an endothelial-facing layer and an elastic outer layer, the inner layer comprising a first ply of foam and a second ply of absorbent nonwoven web, the inner layer and the outer layer being sufficiently elongated to be wrapped around the patient's limb.

[0045] Negative Pressure Wound Therapy In some cases, the treatment of the wound may be performed using negative pressure wound therapy. It will be understood that the embodiments of the present disclosure are generally applicable for use with TNP systems. In brief, negative pressure wound therapy may assist in the closure and healing of many forms of "difficult to heal" wounds by reducing tissue edema, encouraging blood flow and granular tissue formation, and removing excessive exudate, reducing bacterial load (and therefore infection risk). In addition, therapy may reduce wound unrest, leading to faster healing. TNP therapy systems may also assist in the healing of surgically closed wounds by helping to remove fluid and stabilize tissue in an apposed position of closure. Further beneficial uses of TNP therapy may be found in grafts and flaps, where it is important to remove excess fluid and where grafts are required to be in close proximity to tissue to ensure tissue viability.

[0046] Negative pressure therapy may be used to treat open or chronic wounds that are too large to close naturally or that otherwise do not heal with the application of negative pressure to the wound site. A typical negative pressure (TNP) therapy or negative pressure wound therapy (NPWT) system involves placing a fluid-impermeable or semi-permeable covering over the wound, using various means to seal the covering against the patient's tissue surrounding the wound, and connecting a negative pressure source (such as a vacuum pump) to the covering in such a manner that a negative pressure is created and maintained beneath the covering. Such negative pressure is believed to promote wound healing by promoting the formation of granulation tissue at the wound site and supporting the body's normal inflammatory processes while simultaneously removing excess fluid that may contain harmful cytokines or bacteria.

[0047] Some of the dressings used for NPWT may include different types of materials and layers, such as gauze, pads, foam pads, or multi-layer wound dressings. One example of a multi-layer wound dressing is the PICO dressing available from Smith & Nephew, which includes a wound contact layer and a superabsorbent layer under a backing layer to provide a canister-free system for treating wounds with NPWT. The wound dressing may be sealed with a suction port, which provides a connection to a long tube that may be used to pump fluid from the dressing or transfer negative pressure from a pump to the wound dressing. In addition, RENASYS-F, RENASYS-G, RENASYS-AB, and RENASYS-F / AB available from Smith & Nephew are further examples of NPWT wound dressings and systems. Another example of a multi-layer wound dressing is the ALLEVYN Life dressing available from Smith & Nephew, which includes a moist wound environment dressing that is used to treat wounds without the use of negative pressure.

[0048] As used herein, a reduced pressure or negative pressure level, such as -XmmHg, represents a pressure level relative to normal ambient air pressure, which may correspond to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -XmmHg reflects an absolute pressure of XmmHg less than 760mmHg, or in other words, an absolute pressure of (760-X)mmHg. In addition, a negative pressure "lower" or "smaller" than XmmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40mmHg is lower than -60mmHg). A negative pressure "higher" or "larger" than -XmmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80mmHg is higher than -60mmHg). In some cases, the local ambient air pressure is used as a reference point, and such local air pressure may not necessarily be, for example, 760mmHg.

[0049] In some cases of the wound closure devices described herein, increased wound contraction can lead to increased tissue expansion in the surrounding wound tissue. This effect can be increased by varying the force applied to the tissue, for example, varying the negative pressure applied to the wound over time, possibly in conjunction with the increased tensile force applied to the wound by the wound closure device embodiment. In some cases, the negative pressure can be varied over time, for example, using a sine wave, a square wave, or in synchronization with one or more physiological indicators (such as heart rate).

[0050] Any of the embodiments disclosed herein may be modified in any manner, including without limitation WO2010 / 061225, US2016 / 114074, US2006 / 0142560, and US5,703,225, which describe absorbent materials; WO2013 / 007973, which describes non-negative pressure wound dressings; GB1618298.2 (filed October 28, 2016), GB1621057.7 (filed December 12, 2016), and GB1709987.0 (filed June 22, 2017), which describe multi-layer wound dressings; EP2498829 and EP1718 No. 257, describing a compression bandage, WO2006 / 110527, US6,759,566, and US2002 / 0099318, describing wound closure devices, US8,235,955 and US7,753,894, describing negative pressure wound therapy dressings, wound dressing components, wound treatment apparatus, and methods, WO2013 / 175306, WO2016 / 174048, US2015 / 0190286, US2011 / 0282309, and US2016 / 0339158, the disclosures of each of which are incorporated herein by reference in their entirety.

[0051] Substrate Support Sensor Wound dressings incorporating several electronic components, including one or more sensors, can be utilized to monitor wound characteristics. Collecting and analyzing data from a wound can provide useful insight into determining whether the wound is on a healing curve, selecting appropriate therapy, determining whether the wound has healed, etc.

[0052] In some embodiments, some sensor technologies may be used in one or more components that form part of the wound dressing or the overall wound dressing device. For example, as illustrated in Figures 1A-1C, one or more sensors may be incorporated on or in a substrate (such a substrate may be referred to as a "sensor-integrated substrate"). While the substrate is illustrated as having a square shape, it will be understood that the substrate may have other shapes, such as rectangular, circular, oval, etc. In some cases, the substrate supporting one or more sensors may be provided as a separate layer of material that is placed directly or indirectly on or in the wound. The sensor-integrated substrate may 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 may be placed directly or indirectly on or in the wound and then covered by a secondary wound dressing, which may include one or more of gauze, foam, or other wound packing material, a superabsorbent layer, a drape, a fully integrated dressing such as Pico or Allevyn Life dressings manufactured by Smith & Nephew, and the like.

[0053] The sensor-integrated substrate may be placed in contact with the wound and allow fluid to pass through the substrate without causing any or little damage to the tissue in the wound. The substrate may be flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover the wound. For example, the substrate may be made of a stretchable or substantially stretchable material, such as polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene tetraphthalate (PET), polybutarene tetraphthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), and one or more of various fluoropolymer (FEP) and copolymer materials, or another suitable material.

[0054] In some cases, the substrate may include one or more flexible circuit substrates, which may be formed of flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), as well as various fluoropolymers (FEP) and copolymers, and the like. One or more sensors may be incorporated into a two-layer flexible circuit. In some scenarios, the one or more circuit substrates may be multi-layer flexible circuit substrates.

[0055] In some cases, the sensor-integrated substrate may incorporate an adhesive that adheres to wet or dry tissue. In some cases, one or more sensors, on which one or more flexible circuits may be positioned, may be incorporated into any layer of the wound dressing. For example, the wound contact layer may have cutouts or slits that allow one or more sensors to protrude from the lower surface of the wound contact layer and directly contact the wound. In some situations, one or more sensors may be incorporated into or encapsulated within other parts of the wound dressing, such as, for example, the absorbent layer.

[0056] As shown in FIG. 1A, the sensor-integrated substrate 100A may support a number of electronic components and a number of electronic connections interconnecting at least some of the components. The electronic components may be one or more of any electronic components described herein, such as sensors, amplifiers, capacitors, resistors, inductors, controllers, processors, etc. The electronic connections may electrically connect one or more of the electronic components. The electronic connections may be tracks printed on the substrate, such as using copper, conductive inks (silver ink, graphite ink, etc.). At least some of the electronic connections may be flexible or stretchable, or substantially flexible or stretchable.

[0057] The electronic components may include one or more impedance or conductivity sensors 110, which may be arranged in an outer 4×4 grid and an inner 4×4 grid, as illustrated in FIGS. 1A-1C. The sensors 110 are illustrated as pads configured to measure tissue impedance or conductivity across any pair of pads. Two (or more) excitation pads 115 may be arranged as illustrated to provide an excitation signal across the pads, which is conducted by the tissue, and in response, tissue impedance or conductance may be measured across the pads 110. Electrical components, such as one or more amplifiers 120, may be used to measure tissue impedance or conductance. Impedance or conductance measurements may be used to distinguish between live and dead tissue, monitor healing progress, and the like. Arrangement of the pads 110 in the inner and outer grids may be used to measure wound impedance or conductance, wound circumference, or tissue or area surrounding the wound.

[0058] The electronic components may include one or more temperature sensors 130 configured to measure the temperature of the wound or surrounding tissue. For example, nine temperature sensors were positioned around the 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 data obtained from the one or more sensors may be processed to provide information about the wound environment. In some cases, an ambient sensor measuring ambient air temperature may be used to help eliminate problems associated with environmental temperature shifts.

[0059] The 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 may be a light emitting diode (LED), such as one or more white LEDs, red, green, blue (RGB) LEDs, ultraviolet (UV) LEDs, etc. The light sensor may 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, which will cause the light to penetrate into the tissue and exhibit the spectral characteristics of the tissue itself. In some scenarios, the one or more optical sensors may include an imaging device, such as a charge-coupled device (CCD), a CMOS image sensor, etc.

[0060] In some cases, ultra-bright LEDs, RGB sensors, and polyester optical filters may be used as components of one or more optical sensors to measure through tissue color differentiation. For example, color may be measured from light that first passes through tissue for a given geometry, as surface color may be measured from reflected light. This may include color sensing from diffuse light diffused from an LED in contact with the skin, etc. In some cases, an LED may be used with a proximal RGB sensor to detect light diffused through tissue. The optical sensor may image using diffuse internal light or surface reflected light.

[0061] One or more of the electronic components may be controlled by a control module. The control module may receive and process one or more measurements taken by one or more sensors. An external control module may be connected to at least some of the electronic components via a connector 140. In some cases, the connector 140 may be positioned at the end of the conductive track portion as illustrated in FIG. 1B, or attached to the conductive track portion at a location away from the end as illustrated in FIG. 1A or 1C (e.g., attached to the top of the track portion with an adhesive). The control module may include one or more controllers or microprocessors, memory, etc. In some cases, the one or more controllers may be located on the substrate and the connector 140 is not used. In some cases, data and commands may be communicated wirelessly, such as by a transceiver located on the substrate and the connector 140 is not used.

[0062] In some cases, additional or alternative sensors may be positioned on the substrate, such as one or more pH sensors, pressure sensors, irrigation sensors, etc.

[0063] In some cases, the substrate may be perforated as illustrated in FIGS. 1B, 1C. A plurality of perforations 160 may be formed in the substrate 100B to allow fluid to pass through the substrate. It may be advantageous to use the perforated substrate in conjunction with the application of negative pressure wound therapy, during which reduced pressure is applied to a wound covered by the dressing to cause removal of fluid (such as wound exudate) from the wound. The perforations 160 may be formed around a plurality of electronic components and connections as illustrated in FIGS. 1B and 1C. The perforations 160 may be formed as slits or holes. In some cases, the perforations 160 may be small enough to help prevent tissue ingrowth while allowing fluid to pass through the substrate.

[0064] In some cases, any of the wound dressings or wound dressing components described herein may be part of a kit that also includes a negative pressure wound therapy device. One or more components of the kit, such as the sensor-integrated substrate, the secondary dressing, or the negative pressure wound therapy device, may be sterilized.

[0065] Any of the embodiments disclosed herein may be used 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 incorporated herein by reference in its entirety.

[0066] Encapsulation and stress relief In some cases, it may be desirable for the substrate to be stretchable or substantially stretchable to better conform to or cover the wound, but at least some of the electronic components or connections may not be stretchable or flexible. In such cases, when the substrate is positioned in or on the wound, undesirable or excessive localized strain or stress may be exerted on one or more electronic components, such as the support areas or mountings of the electronic components. For example, such stress may result from patient movement, changes in the shape or size of the wound (e.g., due to its healing), and the like. Such stress may cause one or more electronic components or connections to move, fall off, or malfunction (e.g., creating an open circuit from a pin or another connector that is disconnected). Alternatively or additionally, it may be desirable to maintain the position of one or more electronic components, such as one or more sensors, in the same or substantially the same location or area relative to the wound (e.g., in contact with the wound) so that 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 a patient moves, yet it may be desirable to maintain the same or substantially the same position of one or more electronic components relative to the wound.

[0067] 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") may be applied to one or more electronic components, one or more electronic connections, or the like. The hard coat may provide one or more of reinforcement or stress relief for one or more electronic components, one or more electronic connections, or the like. The hard coat may be formed from an acrylated or modified urethane material. For example, the hard coat may 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 may have a viscosity of about 13,500 cP to 50,000 cP before curing, or a viscosity of about 3,600 cP to about 6,600 cP before curing. In some cases, the hard coat may have a viscosity of about 50,000 cP or less. The hard coat may have a hardness of about D40 to about D65 and / or a linear shrinkage of about 1.5 to 2.5%.

[0068] In some cases, another coating(s) may be applied to encapsulate or cover one or more of the substrates or components supported by the substrate, such as electronic connections or components. The coating may provide biocompatibility, shield or protect the electronic circuitry from contact with liquids, provide padding for the electronic components to increase patient comfort, etc. As used herein, biocompatibility may mean conforming to one or more applicable standards, such as ISO10993 or USP Class VI. Such coatings may also be referred to as "conformal coats" or "soft coats." Soft coats may be stretchable or substantially stretchable. Soft coats may be hydrophobic or substantially hydrophobic.

[0069] The soft coat may be formed from one or more suitable polymers, adhesives such as 1072-M adhesive (e.g., Dymax 1072-M), 1165-M adhesive (e.g., Dymax 1165-M, etc.), parylene (e.g., Parylene C, etc.), silicones, epoxies, urethanes, acrylated urethanes, acrylated urethane substitutes (e.g., Henkel Loctite 3381, etc.), or other suitable biocompatible and substantially elastic materials. The soft coat may be a thin coating, for example, from about 80 microns or less to several millimeters or more. The soft coat may have a hardness less than about A100, A80, A50 or less. The soft coat may have an elongation at break of greater than about 100%, 200%, 300%, or more. The soft coat may have a viscosity of about 8,000 to 14,500 centipoise (cP). In some cases, the coating may have a viscosity of about 3,000 cP or more. In some cases, the coating may have a viscosity of less than about 3,000 cP.

[0070] Any of the hard or soft coats described herein may be applied by one or more of lamination, adhesion, welding (e.g., ultrasonic welding), curing by one or more of light, UV, heat (e.g., heating), and the like. Any of the hard or soft coats described herein may be transparent or substantially transparent to facilitate optical sensing. Any of the coatings described herein may retain adhesive strength when subjected to sterilization, such as EtO sterilization. Any of the coatings described herein may be modified to fluoresce, such as under UV light.

[0071] 2A and 2B illustrate cross-sections of wound dressings including a sensor-integrated substrate. Dressing 200A shown in FIG. 2A may include a sensor-integrated substrate 205 supporting a number of electronic components (shown protruding from the substrate) and a number of electronic connections as described herein. Dressing 200A may include a hard coat 214 applied to one or more of the electronic components or connections. In some cases, the hard coat may be applied to areas where the electronic components are connected to the electronic 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.

[0072] The dressing 200A may include a soft coat 216, which may be applied to the entire wound-facing surface of the substrate. The soft coat 216 may be applied to the entire or substantially the entire area of ​​the wound-facing surface of the substrate to encapsulate the substrate, electronic components, and connections. In some cases, the soft coat 216 may be applied to specific regions of the substrate, such as those regions that support one or more of the electronic components or connections.

[0073] 2A, a plurality of perforations 230 may be formed through one or more of the substrate, hard coat, soft coat, and / or wound contact layer. As described herein, the perforations may be made in regions or areas of the substrate that do not support electronic components or connections.

[0074] The dressing 200A may include a protective layer 220 that is applied to the substrate. The protective layer 220 may be made of paper, such as laminated paper. The protective layer 220 may protect the substrate. The protective layer 218 may include multiple (e.g., two) handles. The handles may 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 may be similar to the protective layer used in Allevyn Life Non-Bordered dressings.

[0075] In some cases, the substrate can be used in combination with one or more wicking and / or absorbent layers on the opposing non-wound-facing side (also referred to herein as the second side) of the substrate. The wicking layer can facilitate the passage of fluid through the layers below the wicking layer. For example, the wicking layer can transport fluid away from the underlying layer, such as from the substrate, toward one or more upper layers positioned above the wicking layer. Such one or more upper layers can include one or more absorbent materials as described herein. In some cases, the wicking layer can be formed from a foam, such as a foam similar to that used in Allevyn Life Non-Bordered dressings. The wicking layer can be expandable or substantially expandable.

[0076] As illustrated in the dressing 200B of FIG. 2B, an additional layer of soft coat 210 may be positioned on the non-wound-facing side of the substrate between the substrate and the wicking layer 212. For example, the soft coat 210 may protect the non-wound-facing side of the substrate from fluids if the substrate is formed from a material that is not impermeable to fluids. In such cases, the soft coat 210 may be hydrophobic or substantially hydrophobic. The soft coat 210 may be made of the same or different material as the soft coat 218. The soft coat 210 may be perforated as illustrated and described. In some cases, the soft coat may encapsulate the entire substrate, including both the wound-facing and non-wound-facing sides.

[0077] 3A and 3B illustrate a coated sensor-integrated substrate 300. The substrate 300 is illustrated with the non-wound facing side 216 up. The substrate 300 may be similar to any of the substrates described herein.

[0078] Any of the embodiments described herein may be used 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," which is incorporated by reference in its entirety.

[0079] Coating Technique As described herein, a range of film or substrate materials can be considered.In some cases, polyurethane (PU) materials or films can be used.PU films are typically hydrophilic, so there are many factors that need to be considered in the design of PU films attached to electrical circuits and electronic circuits with components that may contain chemical species (materials) that are desired to be kept isolated from the human body (e.g., chemical species that can be found in electronic components).

[0080] In some cases, once the substrate is formed, the coated substrate can be perforated after coating. It is desirable to coat the front and back sides of the sheet, since wound exudate and vapors of wound exudate will flow onto all surfaces of the wound contact layer. If this is done and the sheet is then perforated, this may expose the edges of the substrate on the cut line. Figures 4A and 4B illustrate uncoated perforations in the substrate. Figures 4A and 4B illustrate an embodiment of a substrate 403 with a coating. In some cases, the substrate 403 is substantially flexible and has a first surface facing the wound and a second surface opposite the first surface, which supports a plurality of electronic components (not shown). The substrate 403 includes a plurality of perforations 405 formed through the substrate, as shown in Figure 4A. The plurality of perforations 405 may have walls 404 on the outer surface of the plurality of perforations 405. In some cases, a substantially non-stretchable coating may be applied to at least a portion of the plurality of electronic components (not shown), as described with reference to Figures 2A and 2B. A first substantially stretchable coating 480 may be applied to a first side of the substrate. In some cases, the first substantially stretchable coating may be applied over a substantially non-stretchable coating as described with reference to FIGS. 2A and 2B. A second substantially stretchable coating 481 may be applied to a second side of the substrate. In some cases, the first substantially stretchable coating and the second substantially stretchable coating may be the same coating material. In some cases, the first substantially stretchable coating and the second substantially stretchable coating may be the same coating material. When a perforation is made or a section is cut after coating, the edge of the substrate may be exposed. As illustrated in FIGS. 4A and 4B, the wall 404 on the outer surface of the perforation 405 remains uncoated when a perforation is made after coating. Liquids, such as aqueous (water-based) liquids or water vapor, may migrate along the substrate in the plane of the substrate under the coating. Defects in the interface bond between the substrate and the sealant may also allow liquid to migrate from the wound to the electronic device.Such imperfections may be present during manufacturing (e.g., gaps, tents, channels between the substrate and sealant) or may be introduced during the life cycle of the sheet (e.g., delamination of the substrate from the sealant or introduction of imperfections, potentially as a result of distortion or repeated strain on the sheet). To address these issues, it may be important to utilize a treatment that coats walls 404 on the outer surfaces of the perforations in the substrate 403. A coated wall 404 of a perforation is illustrated in FIG. 4C. In some cases, as shown in FIG. 4C, the walls 404 of a plurality of perforations may be at least partially coated with at least one of the coatings, as illustrated by coating 440. As used herein, the outer surface of the perforation refers to the surface of the perforation in the channel that will be exposed to wound exudate when the perforated sheet is positioned over a wound.

[0081] Attempting to remove the release handle and / or protective layer after face coating the electronics resulted in stresses being applied across the sheet due to non-uniform stretching of the sheet and the creation of a dimensionally non-uniform sheet. Application of the coating to the back side of the sheet (the side not carrying the electronics) with subsequent curing caused this dimensional non-uniformity. Creating perforations between the electrical tracks and the parts requires a high level of accuracy and precision (e.g., the nominal pitch between tracks may be 200 microns). Perforation methods such as laser ablation based on optical vision systems referencing alignment markers require tight dimensional tolerances on the sheet as it is perforated.

[0082] In some cases, the substrate can be manufactured in the manner shown in FIG. 5. The electronic side of the substrate (or the first side of the substrate) can be first coated with one or more coatings described herein at 501. The substrate can then be perforated at 502. The perforations can be performed in a predefined pattern designed to avoid any of the electronic components, electronic connections, and / or electronic tracks. The substrate can be supported by a protective liner throughout the coating on the electronics side of the substrate and through the perforations. The protective liner can be positioned on the side of the substrate opposite the electronic components (or the second side of the substrate). After perforating the substrate, the protective liner can be removed at 503. Once the protective liner is removed, the second side of the substrate is exposed. The perforated substrate is then placed on a tool having pins corresponding to each perforation 504. The perforated substrate is placed with the electronics side or first side facing down. The second side of the substrate is then coated at 505.

[0083] In some cases, one or more coatings may be applied to the electronics side of the substrate. In some cases, the method of manufacturing a wound dressing may include coating a wound-facing first side or electronics side of a substantially flexible substrate with a first coating. The first side of the substrate may support a plurality of electronic components. The first coating may be applied to at least some of the plurality of electronic components. The method may further include coating the first side with a second coating. In some cases, the second coating may be applied over the first coating.

[0084] The method includes perforating a substrate coated with the first and second coatings to create a plurality of through holes or perforations through the substrate coated with the first and second coatings, wherein the plurality of perforations includes a wall and the plurality of perforations is configured to facilitate the passage of a fluid through the substrate.

[0085] The substrate can have a second surface opposite the first surface. The method can further include coating the second surface of the substrate with a second coating. Any protective liner can be removed from the second surface of the substrate prior to coating the second surface of the substrate. The substrate can be positioned on a tool having a plurality of pins extending through the plurality of perforations when the second coating is applied, allowing the second coating to coat the walls of the plurality of perforations.

[0086] In some cases, after coating the second side of the substrate, the method may further include adhering a protective layer to the substrate, which may be configured to be removed to expose the substrate prior to use.

[0087] This coating technique with a perforated substrate on a tool with pins allows for coating of the back side of the sheet, coating of the internal channels of the perforations, but does not cause detrimental effects on the coating of the electronic side of the sheet. In some cases, this can be achieved by using a tool with pins to deposit abundant material on the edges of the perforations. In some cases, the tool with pins can also provide some stability to the substrate once the protective liner is removed.

[0088] In some cases, the coating on the first side and the coating on the second side of the substrate can be reversed.

[0089] FIG. 6A illustrates an embodiment of a tool 601 with pins 602 that can be used to keep the perforations open when the substrate is coated after the perforations are made. FIG. 6B illustrates an embodiment of a perforated substrate 603 positioned on a tool 601 with pins 602 extending through perforations 605 in the substrate 603. As shown in FIG. 6B, the perforations 605 can be positioned in areas of the substrate that do not support electronic components and / or electronic tracks. FIG. 6C illustrates a substrate 603 in which the perforations 605 are coated with a spray coating after perforations are made in the substrate. The substrate 603 shown in FIG. 6C is positioned on a tool 601 with pins 602 extending through the perforations to prevent perforations from closing due to coating application. In some cases, the coating can extend between the outer surfaces of the perforations to coat the walls on the outer surfaces of the perforations similar to the illustration of the walls 404 in FIG. 4C. In some cases, the substrate 603 can be removed from the tool 601 with the pins before the coating cures. In some cases, when the tool with the pin is removed prior to curing, movement of the pin through the opening of the perforation may allow the coating to be drawn through the perforation and assist in uniformly coating the walls on the exterior surface of the perforation.

[0090] FIG. 7A shows an image of a substrate having perforations coated without using a tool with pins to prevent the coating material from closing the perforations. As shown in the circled area of ​​FIG. 7A, the perforations may experience a reduced size due to the coating closing the perforations. FIG. 7B shows an image of a substrate having perforations coated using a tool with pins, but to prevent the coating from closing the perforations. As shown in FIG. 7B, the perforations are fairly consistent and are more uniform in perforation size.

[0091] In some cases, the size and shape of the pins can be changed to control the flow of coating into the perforation channels. Various designs of pins on the rule can be used. In some cases, the pins on the tool can have a smaller diameter than the diameter of the perforations creating gaps between the perforations in the sheet and the pins. These gaps can affect the amount of uncured coating or sealant that can flow onto the exterior surface of the perforations to coat the walls.

[0092] FIG 8A illustrates a substrate 803 positioned on a tool 801 having a pin 802, the diameter of which is the same or substantially the same as the diameter of a perforation 805 in the substrate 803. As shown in FIG 8A, there is little or no gap between the outer surface of the perforation in the substrate 803 and the pin 802. FIG 8B illustrates a substrate 803 positioned on a tool 801 having a pin 802. As shown in FIG 8B, there is a gap 806 between walls 804 on the outer surface of the perforation in the substrate 803.

[0093] In some cases, designs with pins of different heights or different shapes can be used. This affects the amount of uncured coating or sealant that can accumulate on the pins, flow into the channels of the perforations on the sheet, or otherwise require consideration at the point of extraction of the pins from the perforations and cure on the pins. For example, FIG. 8C illustrates an embodiment with pins that have a higher height than the pins of FIG. 8B.

[0094] In some cases, pins of different shapes can also be used to control the flow of coating onto the substrate and into the channels of the perforations and / or onto the walls on the exterior surface of the perforations. In some cases, the walls of the perforations can have a uniform coating. In some cases, the walls of the perforations can be at least partially non-uniformly coated. In other cases, the walls of the perforations can be coated in a pattern or shape. The pattern or shape of the coating formed on the walls can be created by pins of different designs. In some cases, the size of the perforations can be controlled based on the configuration of the pins.

[0095] In some cases, the perforations may be openings with a diameter of 0.25 mm or larger (measured at the smallest diameter). In some cases, the perforations may be any size or shape. In some cases, the perforations may be oval, elongated, circular, or any other shape. In some cases, multiple perforations may be of various shapes formed in the substrate.

[0096] In some cases, the substrate can have cutouts instead of or in addition to perforations in the substrate. The cutouts can be of any size or shape. In some cases, the cutouts can be oval, elongated, circular, or any other shape. In some cases, the cutouts can be slits or rectangular cutouts in the substrate. In some cases, multiple cutouts can be different shapes formed in the substrate. In some cases, the edges or walls on the outer surface of the cutouts can be coated utilizing methods and techniques similar to those described herein with reference to perforations. The cutouts can be coated using a tool with a pin, which can have a complementary or substantially complementary shape, but in some cases has a smaller size than that of the cutout to allow the coating to pass between the outer surface of the cutout and the side of the pin in the cutout. This process can be similar to the methods and techniques described herein with reference to perforations.

[0097] The pins can be manufactured with design considerations to mitigate or optimize the flow of uncured sealant down the pins onto the substrate and into the channels of the perforations. The pins may be cylindrical, cylindrical with a concave top, cylindrical with a convex top, dome-shaped, conical, hollow, and / or any other shape. In some cases, non-axisymmetric designs may also be used.

[0098] Several factors are important when considering the flow of liquid on the pin. In some cases, the surface energy of the material (high surface energy, low surface energy) may be important in the design of the pin. For example, materials such as silicone, uPVC, PTFE, glass, and 316L stainless steel may be used. The surface finish of the material may be considered. The surface finish of the material may be defined, for example, through the provision of a roughness parameter such as Ra (average roughness value, EN ISO 42871). The use of patterns may be considered. Other considerations may include the temperature of the pin, the temperature of the uncured sealant, and / or the temperature of the entire system during application and curing. The shape of the pin may control the degree of uncured coating or sealant that comes off the pin. The shape of the pin may be coupled with the surface energy of the material, texture, and / or temperature. Figures 8D-8F illustrate embodiments of pins 802 of different shapes that may be used. Figure 8D illustrates a substrate 803 on a tool 801 having a pin 802 with a pointed end. Figure 8E illustrates a substrate 803 on a tool 801 with a dome-shaped pin 802. In some cases, a pointed end or dome shape can help the coating flow onto the outer surface of the perforation under the pin. Figure 8F illustrates a substrate 803 on a tool 801 with a pin 802 with a channel in the pin.

[0099] Figures 8G and 8H illustrate a tool 801 with tapered pins 802. The pins are tapered to control the flow of liquid to the exterior surface of the perforation channel, thereby coating the walls of the perforations. The pins are tapered to aid in the withdrawal of the pins after the coating or sealant has cured. The pins can be tapered at a defined angle, as shown in Figure 8H.

[0100] To avoid excess encapsulant flowing through the perforations and curing on the electronic side of the substrate, a gutter can be introduced into the tool to accommodate excess uncured encapsulant. In some cases, the gutter 808 may be located at the base of the pin 802 where the pin 802 is connected to the rest of the tool 801 as shown in Figures 8I and 8J.

[0101] Given the importance of dimensional accuracy, substrates can benefit from precise location during processing. This can be accomplished through the use of registration markers on the substrate for optics and / or perforations for registration (or reference) pins on the sheet. FIG. 9A illustrates an embodiment of a substrate 903 having perforations 905 and registration markers 909 and corresponding perforations 910 for registration pins 911. In some cases, the registration pin and corresponding registration perforation design can take many forms. For example, perforations used in film (motion picture) stock or photographic negative stock can be used on multiple sides of the sheet to allow multiple registration points.

[0102] In some cases, the allowable gap between registration perforations 910 and corresponding registration pins 911 (shown in FIG. 9B) may be very small to improve accuracy. In contrast, the allowable gap between pins 902 and substrate perforations 905 may be optimized to account for liquid flow around the pins 902 and to the outer surface of the perforation channel as described herein and illustrated in FIG. 9B. In some cases, for each substrate perforation pattern, there may be a corresponding tool with pins.

[0103] A tool base plate 1020 for supporting the substrate 1003 can be used to aid in removal of the substrate 1003 with perforations from the pins 1002 and / or to aid in mitigating undesired pooling of uncured coating or sealant. A tool base plate 1020 as shown in FIG. 10 can be created to support the electronic substrate 1003 and / or to facilitate extraction of the pins 1002 while providing a channel for excess coating or sealant to run off. The tool base plate 1020 can be positioned between the substrate 1003 and the tool 1001 with the pins 1002. The substrate 1003 can be supported by the tool base plate 1020 as the substrate 1003 is pulled out of the tool 1001 with the pins 1002.

[0104] The introduction of channels or microchannels on the outer surface of the sealant may be beneficial to aid in fluid transfer from one side of the sheet to the other. The pins may be made with a profile such that grooves are introduced on the outer surface of the perforation channel when the walls are coated. FIG. 11 shows an embodiment of a cone-shaped pin with ridges or a cut cone with grooves. A cone-shaped pin with ridges can be used to form grooves on the outer surface of the perforation. With other cutouts or shapes on the pin, many other designs are also feasible to generate patterns or shapes on the outer surface of the perforation when the walls are coated.

[0105] In some cases, if the sealant is UV curable, it may be difficult to cure the material that travels along the outer surface of the perforated channel and reaches the opposing side of the sensor sheet. Some materials used in the substrate may block the transmission of certain UV frequencies and therefore block curing. In some cases, tools made of UV transparent materials or UV transparent pins may be considered. Such materials may include: fused silica, quartz, Vycor, Pyrex formulations, sapphire, and various fluorine compounds. Alternatively, both sides of the substrate may be subjected to UV curing after removing the tool with the pins.

[0106] After coating and curing the second side (non-electronic device side) of the substrate, a protective liner may be applied to the second side of the substrate, as shown in Figures 2A and 2B.

[0107] In some cases, the sensor sheet is coated with a hard coat (a substantially non-stretchable coating) on ​​the component side and a soft coat (a substantially stretchable coating). The substrate can then be drilled to form the perforations as described herein. The cutting and drilling can also be extended to cut the contour of the substrate. The substrate can be turned over to remove any protective liner. The substrate can be applied to a tool with pins, and the design of the tool can include a tray such that the outer edge of the sheet is about 2 mm from the edge of the tray, or any suitable distance from the end of the tray, allowing the tray to extend beyond the perimeter of the substrate.

[0108] When the soft coat is spread and / or sprayed onto the pin tool and substrate, it can cover the back side of the substrate and encapsulate all the cut edges of the substrate. In some cases, the soft coat can spread gently, settling and aiding the coating process. In some cases, alignment of the substrate on the pin tool can be important to ensure that the substrate is located at the nominal center (i.e., nominally concentric) of each perforation. Failure to do so can reduce the amount of coating that encapsulates the substrate. In the case of circular perforations, this can result in a (smaller) perforation in the soft coat that is eccentric to the (larger) perforation of the substrate in which it is placed. In other cases, the (smaller) perforation of the soft coat can be concentric to the (larger) perforation of the substrate in which it is placed.

[0109] In some cases, the soft coat may be applied to the second side of the substrate without the use of a tool with pins. In such cases, a second drilling step may be performed to finalize the drilling process. This second drilling step may utilize an optical vision system that can greatly aid in alignment. After the second drilling step, it may be necessary to remove the silicone plug from the drilling spot.

[0110] If the substrate is coated without a tool with pins, the steps of processing the substrate may be similar to those described herein with some modifications. Similar to the steps previously described, the sensor sheet may be hard coated on the component side, and then the soft coat may be applied to the component side or first side of the substrate. The existing process step of perforating the substrate is performed. In some cases, the process of cutting the perforations may also be extended to cut the contour of the substrate. The substrate may be turned over to remove any protective liner. Instead of a tool with pins, the substrate may be placed on a flat tray. In some cases, the tray may be such that the outer edge of the substrate is approximately 1 cm from the edge of the tray. Any size tray that provides an appropriate distance from the perimeter of the substrate to the edge of the tray may be used to allow the tray to extend beyond the perimeter of the substrate. Once the soft coat is spread or sprayed onto the tray and onto the substrate, it may cover the second side of the substrate, fill the perforations, and encapsulate the cut edge of the substrate. The soft coat may spread gently, settle, and aid in coating the entire substrate and edges. Alignment may not be critical in this process. The resulting substrate is then subjected to a second laser drilling step whereby a second set of perforations through the soft coat can be recessed a prescribed amount from the first perforations in the substrate, providing smaller bores and a larger outer sheet profile made in the first cutting step. These steps allow the substrate to be encapsulated with the coating.

[0111] Other Variations In some cases, one or more electronic components may be positioned on the surface of the substrate opposite the wound-facing surface. The systems and methods described herein are equally applicable to such wound contact layers. Although the specific embodiments described herein relate to wound dressings, 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, such as electronic devices that can be worn by or applied to a user.

[0112] Any values ​​of thresholds, limits, periods, etc. provided herein are not intended to be absolute values ​​and therefore may be approximate values. In addition, any thresholds, limits, periods, etc. provided herein may be fixed or variable, either automatically or by a user. Furthermore, as used herein, terms expressing a relative degree, such as above, over, under, etc., in relation to a reference value are intended to encompass equality to the reference value. For example, exceeding a positive reference value can encompass being equal to or greater than the reference value. Additionally, as used herein, terms expressing a relative degree, such as above, over, under, etc., in relation to a reference value are intended to encompass the inverse of the disclosed relationship, such as below, under, over, etc., in relation to a reference value. Furthermore, although various process blocks may be described with respect to determining whether a value reaches or does not reach a particular threshold, the blocks may equally be understood with respect to, for example, whether a value is (i) below or over a threshold, or (ii) meeting or not meeting a threshold.

[0113] It is to be understood that a property, substance, feature, or group described in connection with a particular aspect, embodiment, or example may be applied to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), or all steps of any method or process similarly disclosed, may be combined in any combination, except combinations in which 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, or any novel combination, of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process similarly disclosed.

[0114] Although specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will appreciate that in some cases, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the drawings. In some embodiments, certain steps of the steps described above may be omitted, and others may be added. For example, the actual steps or order of steps performed in the disclosed processes may differ from those shown in the drawings. In some embodiments, certain steps of the steps described above may be omitted, and others may be added. For example, the various components illustrated in the drawings may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, may include logic circuits. Furthermore, 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.

[0115] Although the present disclosure includes specific embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages described herein. Thus, the scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments herein, but may be defined by the claims presented herein or hereafter.

[0116] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context in which it is used, is typically intended to convey that certain embodiments include certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instructions, whether those features, elements, or steps are included in or should be performed in any particular embodiment. Terms such as "comprises," "including," and "having" are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive sense (rather than an exclusive sense), such that, for example, when used connecting a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the term "each" as used herein, in addition to having its ordinary meaning, can also refer to any subset of the series of elements to which the term "each" is applied.

[0117] Conjunctive phrases such as "at least one of X, Y, and Z," unless specifically stated otherwise, are to be construed otherwise in accordance with the context in which they are generally used to suggest that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive phrases are not necessarily intended to suggest that a particular embodiment requires that it includes at least one X, at least one Y, and at least one Z.

[0118] Phrases expressing degrees as used herein, such as the terms "approximately," "about," "generally," and "substantially," are intended to describe a value, amount, or characteristic that is close to a given value, amount, or characteristic that still performs a desired function or produces a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of a given amount.

[0119] The scope of the disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims presented in this section or elsewhere herein, or presented hereafter. The claim language should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during the prosecution of this application, which examples should be interpreted as non-exclusive. [Additional note 1] 1. A wound dressing comprising: a substantially flexible substrate having a first surface facing the wound and a second surface opposite the first surface, the substrate comprising a plurality of perforations formed through the substrate, the plurality of perforations comprising walls on an outer surface of the plurality of perforations; a first substantially elastic coating applied to the first side of the substrate; a second substantially elastic coating applied to a second surface of the substrate; A wound dressing, wherein the walls of the plurality of perforations are at least partially coated with at least one of the coatings. [Additional note 2] 13. The coating of any one of the preceding claims, wherein the walls of the plurality of perforations are at least partially uniformly coated. [Additional note 3] 4. The coating material of claim 1, wherein the plurality of perforations have a diameter of 0.25 mm or more. [Additional note 4] 13. The coating of any one of the preceding claims, wherein the walls of the plurality of perforations comprise a plurality of grooves. [Additional note 5] 13. The coating of any one of the preceding claims, wherein the walls of the plurality of perforations are at least partially non-uniformly coated. [Additional note 6] 13. The coating material of any one of the preceding claims, further comprising a protective layer applied to the second surface of the substrate, the protective layer being configured to be removed to expose the substrate. [Additional note 7] 7. The covering material of claim 6, wherein the protective layer comprises a first and a second portion separated by a slit, the first portion extending over the second portion and covering the slit. [Additional note 8] 13. The dressing of any one of the preceding claims, wherein the plurality of electronic components comprises a plurality of sensors configured to obtain measurements of the wound, at least some of the plurality of sensors interconnected by a plurality of electronic connections. [Additional note 9] 13. The covering of any one of the preceding paragraphs, wherein the first stretchable coating covers substantially an entire area of ​​the first surface of the substrate. [Additional Note 10] 13. The covering of any one of the preceding paragraphs, wherein the second stretchable coating covers substantially an entire area of ​​the second surface of the substrate. [Additional Note 11] 13. The coating of any one of the preceding claims, wherein the first substantially stretchable coating and the second stretchable coating comprise the same material. [Additional Note 12] 13. The dressing of any one of the preceding claims, wherein the walls of the plurality of perforations are at least partially coated with the second stretchable coating. [Additional Note 13] The covering material of any one of the preceding claims, further comprising a first substantially non-stretchable coating applied to at least some of the plurality of electronic components. [Additional Note 14] 14. The covering material of claim 13, wherein the first substantially non-stretchable coating is applied to at least some of the plurality of electronic components, and the first stretchable coating is applied over the substantially non-stretchable coating. [Additional Note 15] 13. The coating of claim 1, wherein the outer wall of a perforation of the plurality of perforations has a first diameter and the perforation of the plurality of perforations has a second diameter formed after at least one of the coatings is applied to the outer wall, the second diameter being within and less than the first diameter. [Additional Note 16] A kit comprising the dressing of any one of the preceding claims and a negative pressure wound therapy device configured to provide negative pressure to the wound covered by the dressing. [Additional Note 17] 17. The kit of claim 16, wherein the dressing and the negative pressure wound therapy device are sterile. [Additional Note 18] 18. The kit of claim 16 or 17, further comprising a secondary dressing configured to be positioned over the dressing of any one of claims 1 to 15. [Additional Note 19] 1. A method of making a wound dressing comprising the steps of: coating a wound-facing first side of a substantially flexible substrate with a first coating, the substrate including a second side opposite the first side, the first side of the substrate supporting a plurality of electronic components, the first coating being applied to at least some of the plurality of electronic components; perforating the substrate coated with the first coating to create a plurality of perforations through the substrate coated with the first coating, the plurality of perforations including a wall, the plurality of perforations configured to facilitate the passage of a fluid through the substrate; and coating the second surface of the substrate with a second coating, wherein the second coating applied to the substrate is positioned on a surface including a plurality of pins extending through the plurality of perforations, and the second coating is at least partially applied to the walls of the plurality of perforations. [Additional Note 20] 20. The method of claim 19, wherein the pins are tapered or dome shaped. [Additional Note 21] 21. The method of claim 19 or 20, further comprising collecting the second coating flowing under the pin in a gutter. [Additional Note 22] 22. The method of any one of claims 19 to 21, wherein coating the second surface of the substrate comprises uniformly applying the second coating to the walls of the plurality of perforations. [Additional Note 23] 22. The method of any one of claims 19 to 21, wherein the walls of the plurality of perforations comprise grooves. [Additional note 24] 22. The method of any one of claims 19 to 21, wherein coating the second surface of the substrate comprises non-uniformly applying the second coating to the walls of the plurality of perforations. [Additional note 25] 25. The method according to any one of claims 19 to 24, further comprising adhering a protective layer to the substrate, the protective layer being configured to be removed to expose the substrate. [Additional note 26] 26. The method of any one of claims 19 to 25, further comprising coating the first surface with a third coating applied to at least some of the plurality of electronic components, wherein the second coating is applied over the third coating. [Additional note 27] 1. A method of making a wound dressing comprising the steps of: coating a wound-facing first side of a substantially flexible substrate with a first coating, the substrate including a second side opposite the first side, the first side of the substrate supporting a plurality of electronic components, the first coating being applied to at least some of the plurality of electronic components; Drilling the substrate coated with the first coating to create a first plurality of perforations through the substrate coated with the first coating, the first plurality of perforations including a wall and having a first diameter; coating the second surface of the substrate with a second coating, the second coating being applied to fill the plurality of perforations and covering the walls of the plurality of perforations; and perforating the substrate coated with the first coating and the second coating to create a second plurality of perforations through the first plurality of perforations in the substrate coated with the first coating and the second coating, the second plurality of perforations having a second diameter, the second plurality of perforations configured to facilitate passage of a fluid through the substrate, the second diameter being within and smaller than the first diameter. [Additional note 28] 13. A wound dressing as shown and / or described. [Additional note 29] A kit comprising a wound dressing as shown and / or described and a negative pressure wound therapy device. [Additional note 30] A method of manufacturing a wound dressing as shown and / or described.

Claims

1. 1. A wound dressing comprising: a substantially flexible substrate having a first surface facing the wound and a second surface opposite the first surface, the substrate comprising a plurality of perforations formed through the substrate, the plurality of perforations comprising walls on an outer surface of the plurality of perforations; a first substantially elastic coating applied to the first side of the substrate; a second substantially elastic coating applied to a second surface of the substrate; A wound dressing, wherein the walls of the plurality of perforations are at least partially coated with at least one of the coatings.

2. The coating of claim 1 , wherein the walls of the plurality of perforations are at least partially uniformly coated.

3. 3. The coating material of claim 1 or 2, wherein the plurality of perforations have a diameter of 0.25 mm or more.

4. The coating of claim 1 , wherein the walls of the plurality of perforations comprise a plurality of grooves.

5. 5. The coating of claim 1, wherein the walls of the plurality of perforations are at least partially non-uniformly coated.

6. and a protective layer applied to the second surface of the substrate, the protective layer being configured to be removed to expose the substrate.

6. The coating of claim 1, wherein the protective layer optionally comprises first and second portions separated by a slit, the first portion extending over the second portion and covering the slit.

7. The coating material of claim 6, wherein the protective layer comprises first and second portions separated by a slit, the first portion extending over the second portion and covering the slit.

8. 8. The dressing of any one of claims 1-7, wherein the plurality of electronic components comprises a plurality of sensors configured to obtain measurements of the wound, at least some of the plurality of sensors interconnected by a plurality of electronic connections.

9. 9. The covering of any one of claims 1 to 8, wherein the first stretchable coating covers substantially an entire area of ​​the first side of the substrate.

10. 10. The covering of any one of claims 1-9, wherein the second stretchable coating covers substantially an entire area of ​​the second side of the substrate.

11. 11. The dressing of any one of claims 1-10, wherein the first substantially elastic coating and the second elastic coating comprise the same material.

12. 12. The dressing of any one of claims 1-11, wherein the walls of the plurality of perforations are at least partially coated with the second stretchable coating.

13. 13. The covering material of claim 1, further comprising a first substantially non-stretchable coating applied to at least some of the plurality of electronic components.

14. 14. The covering material of claim 13, wherein the first substantially non-stretchable coating is applied to at least some of the plurality of electronic components, and the first stretchable coating is applied over the substantially non-stretchable coating.

15. 15. The coating of any one of claims 1-14, wherein the walls of the perforations of the plurality of perforations have a first diameter and the perforations of the plurality of perforations have a second diameter formed after at least one of the coatings is applied to the exterior wall, the second diameter being within and less than the first diameter.

16. A kit comprising a dressing as described in any one of claims 1 to 15 and a negative pressure wound therapy device configured to supply negative pressure to the wound covered by the dressing.

17. 17. The kit of claim 16, wherein the dressing and the negative pressure wound therapy device are sterile.

18. The kit of claim 16 or 17, further comprising a secondary coating configured to be positioned over the coating of any one of claims 1 to 15.

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