Biocompatible sealing and stress relief of components for sensor-compatible negative pressure wound dressings.

Abstract

To provide devices and methods for encapsulating a portion of a wound dressing with a biocompatible coating.SOLUTION: In some embodiments, a method includes coating a first side of a flexible wound contact layer of the wound dressing with a hydrophobic coating. The first side of the wound contact layer can support a plurality of electronic components. The method can further include coating a second side of the wound contact layer opposite the first side with the hydrophobic coating. The wound contact layer can be formed at least partially from hydrophilic material.SELECTED DRAWING: Figure 5B

Description

Technical Field

[0001] [Cross - reference to Related Applications] This application claims priority to U.S. Provisional Application No. 62 / 536,921, filed Jul. 25, 2017, entitled "BIOCOMPATIBLE ENCAPSULATION OF COMPONENTS IN SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS"; U.S. Provisional Application No. 62 / 536,926, filed Jul. 25, 2017, entitled "BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS"; U.S. Provisional Application No. 62 / 556,461, filed Sep. 10, 2017, entitled "BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS"; and UK Provisional Application No. 1804502.1, filed Mar. 21, 2018, entitled "BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS", the entire contents of each of which are incorporated herein by reference.

Background Art

[0002] Embodiments of the present disclosure relate to devices, systems, and methods for the treatment of tissue via sensor - enabled monitoring that communicates with various treatment methods.

[0003] [Explanation of related technologies] While almost every area of ​​medicine could benefit from improved information about the state of the tissues, organs, or systems being treated, especially if such information were collected in real time during treatment, many types of treatments are still routinely performed without the use of sensor data collection. Instead, these treatments rely on visual inspection by caregivers or other limited means rather than quantitative sensor data. For example, in wound treatment via dressings and / or negative pressure wound therapy, data collection is generally limited to visual inspection by caregivers, and often the underlying wound tissue may be obscured by bandages or other visual obstructions. Even intact skin that appears undamaged may have potential damage invisible to the naked eye, such as vascular damage or deep tissue damage that can lead to ulceration. Similarly, during orthopedic procedures requiring limb immobilization with casts or other coverings, only limited information is collected about the underlying tissues. In the case of internal tissue repairs such as bone plates, continuous direct sensor-driven data collection is not performed. Furthermore, fasteners and / or sleeves used to maintain musculoskeletal function do not monitor the function of the underlying muscles or the movement of the limb. Beyond direct interventions, common ward items such as beds and blankets can be improved by adding the ability to monitor patient parameters.

[0004] Therefore, there is a need for improved sensor monitoring, particularly through the use of sensor-enabled substrates that can be incorporated into existing treatment methods. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] According to some embodiments, a method for coating a wound dressing is provided, and the method is The first surface of the flexible wound contact layer of a wound dressing is coated with a hydrophobic coating, wherein the first surface of the wound contact layer supports multiple electronic components. The method includes coating the second surface of the wound contact layer opposite the first surface with a hydrophobic coating, wherein the wound contact layer is formed at least partially from a hydrophilic material.

[0006] A method for coating a wound dressing as described in any of the preceding paragraphs may further include one or more of the following features: The method may include sealing the wound contact layer with the coating. The coating may be hydrophobic, biocompatible, and / or substantially stretchable. Multiple electronic components may have at least one electronic connection. The method may further include coating at least some of the multiple electrical components with multiple coating layers. Coating the first and second surfaces of the wound contact layer may include spraying the coating. Spraying may include spraying using compressed air or an inert gas. The coating may be formed from a material conforming to the IEC 60601 standard.

[0007] According to some embodiments, a method for coating a wound dressing is provided, and the method is Coating multiple electronic components supported by the first surface of the flexible wound contact layer of a wound dressing with a first biocompatible coating, The method includes coating one or more remaining areas of the first surface of the wound contact layer and the second surface of the wound contact layer opposite the first surface with a second biocompatible coating.

[0008] In some embodiments, those described in any of the preceding paragraphs may include one or more of the following features: The first coating may be substantially non-stretchable. The first coating may include at least one of Dymax 20351, Dymax 20558, Dymax 9001-E, or Loctite 3211. The wound contact layer may be formed from at least a partially hydrophilic material. The first and second coatings may be hydrophobic and / or formed from materials conforming to IEC 60601 standard. The first coating may have a viscosity of about 50,000 centipoise or less.

[0009] According to some embodiments, a method for coating a wound dressing is provided, and the method is Coating multiple electronic components supported by the first surface of the flexible wound contact layer of a wound dressing with a non-biocompatible coating, The method includes coating a first surface of a wound contact layer, which comprises multiple electronic components, and a second surface of the wound contact layer opposite the first surface, with a biocompatible coating.

[0010] The method described in any of the preceding paragraphs may include one or more of the following features: The non-biocompatible coating may be substantially non-stretchable. In some embodiments, coating the first wound contact layer with a biocompatible coating includes coating a non-biocompatible coating over a plurality of electronic components. The biocompatible coating may be hydrophobic and / or formed from a material conforming to IEC 60601 standard.

[0011] According to some embodiments, a method for coating a wound dressing is provided, and the method is The method involves positioning a flexible wound contact layer of a wound dressing between a first and a second frame under substantially tension, wherein the wound contact layer comprises a first surface supporting a plurality of electronic components protruding from the surface of the first surface and a second surface opposite the first surface, the second surface being substantially smooth. This includes coating the wound contact layer with a biocompatible coating.

[0012] A method according to any of the preceding paragraphs may include one or more of the following features: The method may further include supporting a first surface of a wound contact layer in a substantially flat position by a mold, the mold having a plurality of recesses configured to support a plurality of electronic components, and applying a coating substantially uniformly to a second surface of the wound contact layer. The method may further include supporting a second surface of the wound contact layer in a substantially flat position between a first frame and a second frame, and applying a coating substantially uniformly to the first surface of the wound contact layer. In some embodiments, the coating may include spraying a biocompatible coating and / or sealing the wound contact layer with the biocompatible coating. Spraying may include spraying using compressed air or an inert gas. The biocompatible coating is formed from a material conforming to the IEC 60601 standard. In some embodiments, the method may further include forming at least one perforation in a substantially flexible wound contact layer before coating the first surface of the substantially flexible wound contact layer supporting a plurality of electronic components. The method may further include forming at least one perforation beneath at least one electronic component. If the first surface is coated, the method may further include applying higher pressure to the first surface than to the second surface of a substantially flexible wound contact layer.

[0013] According to some embodiments, The method involves arranging multiple electronic components on the first surface of the wound contact layer of a wound dressing, wherein the wound contact layer is at least partially formed from a hydrophilic material. The first surface of the wound contact layer, which contains multiple electronic components, is coated with a hydrophobic coating, A wound dressing is provided, prepared by a process that includes coating a second surface opposite to a first surface of the wound contact layer with a hydrophobic coating.

[0014] A wound dressing described in any of the preceding paragraphs may include one or more of the following features: The wound contact layer may be flexible. The coating may be biocompatible, substantially stretchable, and / or formed from a material conforming to IEC 60601. The process may further include coating a plurality of electronic components with another substantially non-stretchable coating before coating the first surface of the wound contact layer with a hydrophobic coating. The process may further include forming at least one perforation in the wound contact layer before coating the first surface of the wound contact layer supporting the plurality of electronic components. At least one perforation may be formed beneath at least one electronic component. When coating the first surface, the process may further include applying higher pressure to the first surface of the wound contact layer than to the second surface.

[0015] According to some embodiments, wound dressings are provided that are manufactured and / or coated by any of the methods described herein.

[0016] According to some embodiments, an apparatus for coating wound dressings is provided, and the apparatus is The first frame and A second frame configured to be attached to a first frame and further configured to fix a flexible wound contact layer of a wound dressing between the first and second frames, wherein the wound contact layer includes a first surface supporting a plurality of electronic components protruding from the surface of the first surface, and a second surface opposite the first surface, the second surface being substantially smooth, the second frame comprises The first and second frames are configured to substantially support the wound contact layer under tension so that a biocompatible coating can be applied to the first and second surfaces of the wound contact layer.

[0017] The apparatus described in any of the preceding paragraphs may include one or more of the following features: The apparatus may further comprise a base and a mold having a plurality of recesses configured to support a plurality of electronic components, wherein the mold and the first frame are configured to be positioned on the base, and the mold is further configured to support a first surface of the wound contact layer in a substantially flat position so that the coating can be applied substantially uniformly to a second surface of the wound contact layer. The mold may be configured to support a plurality of wound contact layers in a substantially flat position, wherein at least the first wound contact layer of the plurality of wound contact layers has a different arrangement of electronic components than the second wound contact layer of the plurality of wound contact layers. The wound contact layer may comprise thermoplastic polyurethane. The coating may comprise a urethane acrylate and / or be applied to seal the wound contact layer. At least one of the plates or mold may comprise nylon or polytetrafluoroethylene (PTFE). In some embodiments, the coating may be applied as a spray. The apparatus may further include a spraying device configured to dispense an uncured coating onto a wound contact layer, thereby removing oxygen and curing the coating, and comprising a storage unit filled with compressed air or an inert gas. The wound contact layer may be configured for use in providing negative pressure wound therapy.

[0018] According to some embodiments, an apparatus for coating wound dressings is provided, and the apparatus is A body having a plurality of recesses configured to support a plurality of electronic components supported on a first surface of a wound contact layer of a wound dressing material, the plurality of electronic components protruding from the surface of the first surface, and the wound contact layer further including a substantially smooth second surface on the opposite side of the first surface, The body is configured to support the first surface of the wound contact layer in a substantially flat position so that a biocompatible coating can be applied to the second surface of the wound contact layer.

[0019] The device according to any of the preceding paragraphs may include one or more of the following features. The plurality of recesses may be shaped and arranged to substantially conform to the shape and arrangement of the plurality of electronic components.

[0020] According to some embodiments, a method of coating an electronic device is provided, the method comprising: coating a first surface of a flexible substrate of an electronic device with a hydrophobic coating, the first surface of the substrate supporting a plurality of electronic components; coating a second surface of the substrate on the opposite side of the first surface with a hydrophobic coating, the substrate being at least partially formed from a hydrophilic material.

[0021] According to some embodiments, a method for coating an electronic device is provided, the method comprising: coating a plurality of electronic components supported by a first surface of a flexible substrate of an electronic device with a first biocompatible coating; coating one or more remaining regions of the first surface of the substrate and the second surface of the substrate on the opposite side of the first surface with a second biocompatible coating.

[0022] According to some embodiments, a method for coating an electronic device is provided, the method comprising: coating a plurality of electronic components supported by a first surface of a flexible substrate of an electronic device with a non - biocompatible coating; Coating a first surface of a substrate having a plurality of electronic components and a second surface of the substrate opposite the first surface with a biocompatible coating.

[0023] According to some embodiments, a method for coating an electronic device is provided, the method comprising: Disposing a flexible substrate of an electronic device substantially under tension between a first and a second frame, the substrate having a first surface supporting a plurality of electronic components protruding from the surface of the first surface and a second surface opposite the first surface, the second surface being substantially smooth; Coating the substrate with a biocompatible coating.

[0024] Other embodiments of wound dressings, devices, kits and related methods are described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Here, embodiments of the present disclosure will be described below by way of example only with reference to the accompanying drawings.

[0026] [Figure 1] FIG. 1A is a negative pressure wound treatment system according to some embodiments. FIG. 1B is a wound dressing according to some embodiments. [Figure 2] FIG. 2 is a sensor array illustrating the placement of sensors incorporated in a wound dressing according to some embodiments. [Figure 3A] FIG. 3A is a flexible sensor array comprising a sensor array portion, a tail portion, and a connector pad end according to some embodiments. [Figure 3B-1] FIG. 3B is a flexible circuit substrate having different sensor array shapes according to some embodiments. [Figure 3B-2] FIG. 3B is a flexible circuit substrate having different sensor array shapes according to some embodiments. [Figure 3C]Figure 3C shows the sensor array portion of the sensor array shown in Figure 3B. [Figure 3D] Figure 3D shows a flexible sensor array incorporated within a perforated wound contact layer, according to several embodiments. [Figure 3E] Figure 3E shows a control module according to several embodiments. [Figure 4A] Figure 4A shows wound dressings comprising multiple electronic components according to several embodiments. [Figure 4B] Figure 4B shows wound dressings comprising multiple electronic components according to several embodiments. [Figure 4C] Figure 4C shows wound dressings comprising multiple electronic components according to several embodiments. [Figure 5A] Figure 5A shows wound dressing coatings according to several embodiments. [Figure 5B] Figure 5B shows several embodiments of wound dressing coatings. [Figure 6] Figure 6 shows wound dressings coated with two biocompatible coatings according to several embodiments. [Figure 7] Figure 7 shows several embodiments of wound dressings coated with biocompatible coatings. [Figure 8] Figure 8 shows an apparatus for coating wound dressings according to several embodiments. [Figure 9] Figure 9 shows spray coating of wound dressings according to several embodiments. [Figure 10] Figure 10 shows molds for coating wound dressings according to several embodiments. [Figure 11] Figure 11 shows another apparatus for coating wound dressings according to several embodiments. [Figure 12A] Figure 12A shows assembled devices for coating wound dressings according to several embodiments. [Figure 12B]Figure 12B shows assembled devices for coating wound dressings according to several embodiments. [Figure 13] Figure 13 shows several embodiments of release liners for coating wound dressings. [Figure 14A] Figure 14A shows wound dressing coatings according to several embodiments. [Figure 14B] Figure 14B shows wound dressing coatings according to several embodiments. [Figure 15] Figure 15 shows spray coating of wound dressings according to several embodiments. [Figure 16] Figure 16 shows the application of non-stretchable materials to wound dressings according to several embodiments. [Figure 17] Figures 17A to 17B show a comparison of performance with and without non-stretchable materials in several embodiments. [Figure 18] Figure 18 shows wound dressings having one or more perforations, according to several embodiments. [Figure 19A] Figure 19A shows a coating of a wound dressing having one or more perforations, according to several embodiments. [Figure 19B] Figure 19B shows a coating of a wound dressing having one or more perforations, according to several embodiments. [Modes for carrying out the invention]

[0027] Embodiments disclosed herein relate to apparatus and methods for monitoring and treating biological tissues using sensor-enabled substrates. The embodiments disclosed herein are not limited to the treatment or monitoring of specific types of tissue or injury; rather, the sensorable technologies disclosed herein are broadly applicable to any type of therapy that may benefit from sensor-enabled substrates. Some implementations utilize sensors and data collection requested by healthcare providers to make both diagnostic and patient management decisions.

[0028] Some embodiments disclosed herein relate to the use of sensors mounted on or embedded within a substrate configured for use in the treatment of both intact and damaged human or animal tissue. Such sensors collect information about the surrounding tissue and transmit such information to a computing device or caregiver for use in further treatment. In certain embodiments, such sensors can be attached to the skin anywhere on the body, including areas for monitoring arthritis, temperature, or other areas that may be problematic and require monitoring. The sensors disclosed herein may also incorporate markers, such as radiopaque markers, to indicate the presence of the device, for example, before performing MRI or other techniques.

[0029] 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, trousers, pantaloons, dresses, underwear, jackets, gloves, shoes, hats, and other suitable garments. In certain embodiments, the sensor embodiments disclosed herein may be welded to or laminated into a particular garment. The sensor embodiments may be printed directly onto the garment and / or embedded within the fabric. Breathable and printable materials, such as microporous membranes, may also be suitable.

[0030] The sensor embodiments disclosed herein can be incorporated into cushioning or bed padding, such as in a hospital bed, to monitor patient characteristics, such as any of the characteristics disclosed herein. In certain embodiments, a disposable film containing such sensors may be placed on hospital bedding and removed / replaced as needed.

[0031] In some embodiments, the sensor embodiments disclosed herein may incorporate energy harvesting such that the sensor embodiment is 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.

[0032] The sensor embodiments disclosed herein may be used in rehabilitation devices and treatments, including sports medicines. For example, the sensor embodiments disclosed herein may be used in struts, sleeves, wraps, supports, and other suitable items. Similarly, the sensor embodiments disclosed herein may be incorporated into sports equipment such as helmets, sleeves, and / or pads. For example, such sensor embodiments may be incorporated into protective helmets to monitor characteristics such as acceleration, which may be useful in diagnosis.

[0033] The sensor embodiments disclosed herein may be used in conjunction with surgical devices, such as the NAVIO surgical system from Smith & Nephew Inc. In some embodiments, the sensor embodiments disclosed herein may communicate with surgical devices to guide their placement. In some embodiments, the sensor embodiments disclosed herein may monitor blood flow to a potential surgical site or ensure that there is no blood flow to a surgical site. Further surgical data may be collected to assist in preventing scarring and to monitor areas far from the affected area.

[0034] To further assist surgical techniques, the sensors disclosed herein may be incorporated into surgical drapes to provide information about tissues beneath the drape that are not directly visible to the naked eye. For example, a flexible drape with an integrated sensor may have a sensor advantageously positioned to provide improved area-intensive data acquisition. In certain embodiments, the sensor embodiments disclosed herein may be incorporated within or at the boundary of the drape to create a fence that restricts / controls the surgical system.

[0035] The sensor embodiments disclosed herein may also be used for the evaluation of surgical procedures. For example, such sensor embodiments may be used to collect information about a potential surgical site by monitoring the skin and underlying tissue for potential incision sites. For example, perfusion levels or other appropriate characteristics may be monitored at the surface of the skin and deep within the tissue to assess whether an individual patient may be at risk of surgical complications. Sensor embodiments such as those disclosed herein may be used to assess the presence of bacterial infection and provide indications for the use of antimicrobial agents. Furthermore, the sensor embodiments disclosed herein may be able to collect further information in deeper tissues, such as identifying pressure ulcer injuries and / or adipose tissue levels.

[0036] The sensor embodiments disclosed herein may be used in cardiovascular monitoring. For example, such sensor embodiments may be incorporated into a flexible cardiovascular monitor that can be placed on the skin to monitor characteristics of the cardiovascular system and transmit such information to another device and / or 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 used in neurophysiological applications, such as monitoring the electrical activity of neurons.

[0037] 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 collect information about the implant site and transmit this information to an external source. In some embodiments, the internal source may also provide power for such implants.

[0038] The sensor embodiments disclosed herein may also be used to monitor biochemical activity on or beneath the surface of the skin, such as muscle lactose production or sweat production on the skin surface. In some embodiments, other features 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 ripping.

[0039] The sensor embodiments disclosed herein may be incorporated into ear, nose, and throat (ENT) applications. For example, such sensor embodiments may be used to monitor recovery from ENT-related surgery, such as in the case of wound monitoring within the nasal tract.

[0040] As will be described in more detail below, the sensor embodiments disclosed herein may encompass sensor printing techniques involving sealing, such as sealing with a polymer film. Such films may be constructed using any polymer described herein, such as polyurethane. Sealing of the sensor embodiments may provide waterproofing and protection of the electronic device from local tissue, local fluids, and other potential sources of damage.

[0041] In certain embodiments, the sensors disclosed herein may be incorporated into an organ protection layer as disclosed below. Such a sensor-integrated organ protection layer protects the target organ and can ensure that the organ protection layer is in place and provides protection. Furthermore, the sensor-integrated organ protection layer can be used to monitor the underlying organ by monitoring blood flow, oxygenation, and other appropriate markers of organ health. In some embodiments, a sensor-enabled organ protection layer may be used to monitor a transplanted organ by monitoring the organ's fat and muscle content. Furthermore, a sensor-enabled organ protection layer may be used to monitor the transplanted and post-transplanted organ, such as during organ rehabilitation.

[0042] 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 of the sensor embodiments disclosed herein include monitoring and treating intact skin, applications to the cardiovascular system for monitoring blood flow, orthopedic applications such as monitoring limb movement and bone repair, neurophysiological applications such as monitoring electrical shock, and any other tissues, organs, systems, or conditions that may benefit from improved sensor-effective monitoring.

[0043] [Wound therapy] Some embodiments disclosed herein relate to wound therapy for the human or animal body. Therefore, any reference to wounds herein may refer to wounds on the human or animal body, and any reference to the body herein may refer to the human or animal body. The disclosed technological embodiments may relate to preventing or minimizing damage to physiological or biological tissue, or to the treatment of damaged tissue (e.g., wounds described herein) with or without decompression, including, for example, negative pressure sources and wound dressing components and devices. Wound overlays and packing materials, or devices and components including an inner layer if present, are sometimes collectively referred to herein as dressings. In some embodiments, wound dressings may be provided for use without decompression.

[0044] Some embodiments disclosed herein relate to wound therapy for the human or animal body. Therefore, any reference to wounds herein may refer to wounds on the human or animal body, and any reference to the body herein may refer to the human or animal body. The disclosed technological embodiments may relate to the prevention or minimization of damage to physiological or biological tissue, or the treatment of damaged tissue (e.g., wounds as described herein).

[0045] As used herein, the term “wound” may include injury to living tissue, typically resulting in a cut or tear of skin, which may be caused by a cut, blow, or other impact. Wounds can be chronic or acute injuries. Acute wounds result from surgery or trauma. They progress through stages of healing over an expected period. Chronic wounds typically begin as acute wounds. Acute wounds can become chronic wounds if they do not follow the healing stages, resulting in a longer recovery. The transition from acute to chronic wounds may be due to the patient becoming immunized.

[0046] 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 artery disease, pressure ulcers, or epidermolysis bullosa (EB).

[0047] Other examples of wounds include, but are not limited to, abdominal wounds, or other large or incisional wounds, dehiscences, acute wounds, chronic wounds, subacute 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 as a result of surgery, trauma, sternotomy, fasciotomy, or any other condition.

[0048] Wounds can also include deep tissue injuries. Deep tissue injury is a term proposed by the Government Pressure Ulcer Advisory Panel (NPUAP) to describe a specific form of pressure ulcer. These ulcers have long been described by clinicians using terms such as purple pressure ulcers, ulcers that are likely to worsen and rupture due to bony prominences, and so on.

[0049] The wound may also include tissue at risk of wounding, as described herein. For example, tissue at risk may include tissue covering a bony prominence (at risk of deep tissue injury / injury) or pre-operative tissue that may be cut (e.g., for joint replacement / surgical modification / reconstruction) (such as knee tissue).

[0050] Some embodiments describe methods for treating wounds by combining the techniques disclosed herein with one or more of the following: advanced footwear, patient rotation (such as off-road treatment for diabetic foot ulcers), treatment of infection, systemics, antimicrobial agents, antibiotics, surgery, tissue removal, affecting blood flow, physiotherapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, activator ozone, antibiotics, antimicrobial agents, etc.

[0051] Alternatively or in addition, wounds may be treated using conventional advanced wound care that is not aided by the use of local negative pressure and / or applied negative pressure (sometimes called non-negative pressure therapy).

[0052] Advanced wound care includes the use of absorbent dressings, occlusive dressings, antimicrobial agents and / or cleansing agents in wound dressings or adnexa, and the use of pads (e.g., cushioning or compression therapy such as stockings or bandages).

[0053] In some embodiments, such wounds can be treated using conventional wound care, which involves applying a wound dressing to facilitate and accelerate wound healing.

[0054] Some embodiments relate to methods for producing wound dressings, including providing wound dressings disclosed herein.

[0055] Wound dressings that may be used in conjunction with the disclosed technology include any known dressings known in the art. This technology is applicable to negative pressure therapy and non-negative pressure therapy.

[0056] In some embodiments, the wound dressing includes one or more absorbent layers. The absorbent layers may be foams or superabsorbent materials.

[0057] In some embodiments, the wound dressing may include a dressing layer comprising polysaccharides or modified polysaccharides, polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl ether, polyurethane, polyacrylate, polyacrylamide, collagen, or gelatin or a mixture thereof. Dressing layers comprising the listed polymers are known in the art to be useful for forming wound dressing layers for either negative pressure therapy or non-negative pressure therapy.

[0058] In some embodiments, the polymer matrix may be a polysaccharide or a modified polysaccharide.

[0059] In some embodiments, the polymer matrix may be cellulose. The cellulose material may include hydrophilic modified cellulose such as methylcellulose, carboxymethylcellulose (CMC), carboxymethylcellulose (CEC), ethylcellulose, propylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxyethyl sulfonate cellulose, cellulose alkyl sulfonate, or mixtures thereof.

[0060] In certain embodiments, the cellulose material may be a cellulose alkyl sulfonate. The alkyl portion of the sulfate alkyl substituent may have an alkyl group having 1 to 6 carbon atoms, such as methyl, ethyl, propyl, or butyl. The alkyl portion may be branched or unbranched, and therefore a suitable propyl sulfonate substituent may be 1- or 2-methyl-ethyl sulfonate. The butyl sulfonate substituent may be 2-ethyl-ethyl sulfonate, 2,2-dimethyl-ethyl sulfonate, or 1,2-dimethyl-ethyl sulfonate. The alkyl sulfonate substituent may be ethyl sulfate. Cellulose alkyl sulfonates are described in International Patent No. 10061225, U.S. Patent No. 2016 / 114074, U.S. Patent No. 2006 / 0142560, or U.S. Patent No. 5,703,225, the disclosures thereof are incorporated herein by reference in their entirety.

[0061] Cellulose alkyl sulfonates can have various substitutions, chain lengths of the cellulose backbone structure, and structures of alkyl sulfonate substituents. Solubility and absorption depend on the degree of substitution; the more substitutions there are, the more soluble the cellulose alkyl sulfonate becomes. Increased solubility leads to increased absorption.

[0062] In some embodiments, the wound dressing also includes an upper or cover layer.

[0063] The thickness of the wound dressings disclosed herein may be 1 to 20 mm, or 2 to 10 mm, or 3 to 7 mm.

[0064] In some embodiments, the disclosed technology may be used in conjunction with non-negative pressure wound dressings. Non-negative pressure wound dressings suitable for providing protection at the wound site may include:

[0065] An absorbent layer for absorbing wound exudate,

[0066] It may include a blocking element for at least partially blocking the view of wound exudate absorbed by the absorbent layer during use.

[0067] The blocking element may be partially semi-transparent.

[0068] The blocking element can be a masking layer.

[0069] Non-negative pressure wound dressings may further include regions within or adjacent to the barrier element so that the absorbent layer can be seen. For example, the barrier element layer may be provided over the central region of the absorbent layer and not over the boundary region of the absorbent layer. In some embodiments, the barrier element is made of a hydrophilic material or is coated with a hydrophilic material.

[0070] The blocking element may include a three-dimensional knitted spacer fabric. Spacer fabrics are well known in this industry and may include a knitted spacer fabric layer.

[0071] The blocking element may further include indicators to show the need to change the covering material.

[0072] In some embodiments, the barrier element is provided as a layer at least partially on top of the absorbent layer, and at a distance from the wound site than the absorbent layer during use.

[0073] Non-negative pressure wound dressings may further include multiple openings in a barrier element to allow fluid to move through it. The barrier element may include, or be coated with, a material having size exclusion properties to selectively allow or prevent the passage of molecules of a given size or weight.

[0074] The shielding element may be configured to at least partially shield light radiation having wavelengths of 600 nm or less.

[0075] The blocking element may be configured to reduce light absorption by more than 50%.

[0076] The blocking element may be configured to produce a CIE L* value of 50 or higher, and optionally 70 or higher. In some embodiments, the blocking element may be configured to produce a CIE L* value of 70 or higher.

[0077] In some embodiments, the non-negative pressure wound dressing may further include at least one of a wound contact layer, a foam layer, an odor suppression element, a pressure-resistant layer, and a cover layer.

[0078] In some embodiments, a cover layer is present, which is a semi-transparent film. Generally, semi-permeable films have a vapor permeability of 500 g / m² / 24 hours or more.

[0079] Semipermeable films can serve as bacterial barriers.

[0080] In some embodiments, the non-negative pressure wound dressings disclosed herein include a wound contact layer, the absorbent layer being located on top of the wound contact layer. The wound contact layer carries an adhesive portion for forming a substantially fluid seal over the wound site.

[0081] Non-negative pressure wound dressings disclosed herein may include a barrier element and an absorbent layer provided as a single layer.

[0082] In some embodiments, the non-negative pressure wound dressings disclosed herein include a foam layer, and the barrier element is a material that includes components that can be moved or destroyed by the movement of the barrier element.

[0083] In some embodiments, the non-negative pressure wound dressing includes an odor suppression element, while in other embodiments, the dressing does not include an odor suppression element. When present, the odor control element may be dispersed within or adjacent to the absorbent layer or the barrier element. Alternatively, if present, the odor control element may be provided as a layer sandwiched between the foam layer and the absorbent layer.

[0084] In some embodiments, the techniques disclosed for non-negative pressure wound dressings include a method for manufacturing a wound dressing, the method including providing an absorbent layer for absorbing wound exudate and providing a barrier element for at least partially blocking the view of the wound exudate absorbed by the absorbent layer during use.

[0085] In some embodiments, a non-negative pressure wound dressing may be suitable for providing protection at the wound site, comprising an absorbent layer for absorbing wound exudate and a shielding layer provided on top of the absorbent layer, further away from the wound-facing side of the wound dressing than the absorbent layer. The shielding layer may be provided directly on top of the absorbent layer. In some embodiments, the shielding layer includes a three-dimensional spacer fabric layer.

[0086] The shielding layer increases the area over which the pressure applied to the covering material moves by 25% or more, or the initial range of application. For example, the shielding layer increases the area over which the pressure applied to the covering material is transmitted by 50% or more, optionally by 100% or more, optionally by 200% or more.

[0087] The shielding layer may include two or more sublayers, the first sublayer including through holes, and the subsequent sublayers including through holes, wherein the through holes of the first sublayer are offset from the through holes of the subsequent sublayers.

[0088] The non-negative pressure wound dressings disclosed herein may further comprise a permeable cover layer that allows gas and vapor to pass through, the cover layer being provided on top of the shielding layer, and the through-holes of the cover layer being offset from the through-holes of the shielding layer.

[0089] Non-negative pressure wound dressings may be suitable for the treatment of pressure ulcers.

[0090] A more detailed description of the non-negative pressure covering materials disclosed herein is provided in International Patent Publication No. 2013007973, which is incorporated herein by reference in its entirety.

[0091] In some embodiments, the non-negative pressure wound dressing may be a multilayer wound dressing comprising a fibrous absorbent layer for absorbing exudate from the wound site and a support layer configured to reduce shrinkage of at least a portion of the wound dressing.

[0092] In some embodiments, the multilayer wound dressings disclosed herein further comprises a liquid-impermeable film layer, and a support layer is positioned between the absorbent layer and the film layer.

[0093] The support layers disclosed herein may include a net. The net may include a geometric structure having a plurality of substantially geometric openings extending through it. The geometric structure may include a plurality of projections substantially evenly spaced by polymer chains to form substantially geometric openings between polymer chains, for example.

[0094] The net can be formed from high-density polyethylene.

[0095] The opening may have an area of ​​0.005 to 0.32 mm².

[0096] The supporting layer may have a tensile strength of 0.05 to 0.06 Nm.

[0097] The supporting layer may have a thickness of 50 to 150 μm.

[0098] In some embodiments, the support layer is positioned directly adjacent to the absorbent layer. Typically, the support layer is bonded to the fibers on the top surface of the absorbent layer. The support layer may further comprise a binding layer, where the support layer is laminated to the fibers in the absorbent layer via the binding layer. The binding layer may include a low-melting-point adhesive, such as an ethylene vinyl acetate adhesive.

[0099] In some embodiments, the multilayer wound dressings disclosed herein further comprises an adhesive layer for adhering the film layer to the retaining layer.

[0100] In some embodiments, the multilayer wound dressings disclosed herein further comprises a wound contact layer positioned adjacent to an absorbent layer adjacent to the wound. The multilayer wound dressing may further include a fluid transport layer between the wound contact layer and the absorbent layer for transporting exudate from the wound to the absorbent layer.

[0101] A more detailed description of the multilayer wound dressings disclosed herein is provided in GB Patent Application No. GB1618298.2, filed October 28, 2016, which is incorporated herein by reference in its entirety.

[0102] In some embodiments, the disclosed technology may be incorporated into a wound dressing comprising a vertically overlapping material comprising a first layer of absorbent material and a second layer of material, wherein the first layer is constructed from at least one layer of nonwoven fibers, the nonwoven fibers being folded at multiple folds to form a pleated structure. In some embodiments, the wound dressing further comprises a second layer of material temporarily or permanently bonded to the first layer of material.

[0103] Typically, vertically overlapping materials have notches cut into them.

[0104] In some embodiments, the first layer has a pleated structure with a depth determined by the depth of the pleats or by the width of the cuts. The first layer of material may be a molded, lightweight, fibrous material, a mixture of materials, or a composition layer.

[0105] The first layer of the material may include one or more fibers made from synthetic, natural, or inorganic polymers, or natural fibers of cellulosic, proteinaceous, or mineral origin.

[0106] The wound dressing may include two or more layers of absorbent materials stacked on top of each other, with the two or more layers having the same or different densities or compositions.

[0107] In some embodiments, the wound dressing may consist of only one layer of the absorbent layers of the material vertically overlapping materials.

[0108] The absorbent layer of the material is typically made of natural or synthetic, organic or inorganic fibers, and binder fibers, or bicomponent fibers with a low melting temperature PET coating to soften at a specific temperature and act as a binder for the overall blend, usually PET.

[0109] In some embodiments, the absorbent layer of the material may be a blend of 5-95% thermoplastic polymer and 5-95% by weight of cellulose or a derivative thereof.

[0110] In some embodiments, the wound dressings disclosed herein include a second layer comprising a foam or a dressing fixative.

[0111] The foam may be a polyurethane foam. The polyurethane foam may have an open or closed void structure.

[0112] The dressing fixative may include bandages, tapes, gauze, or backing layers.

[0113] In some embodiments, as disclosed herein, the wound dressing includes an absorbent layer of material directly bonded to a second layer by lamination or adhesive, the second layer being connected to a dressing fixing layer. The adhesive may be an acrylic adhesive or a silicone adhesive.

[0114] In some embodiments, as disclosed herein, the wound dressing further comprises a layer of superabsorbent fibers, or viscose fibers or polyester fibers.

[0115] In some embodiments, as disclosed herein, the wound dressing 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).

[0116] Detailed descriptions of the multilayer wound dressings disclosed herein are provided in the UK Patents, application number GB1621057.7 filed December 12, 2016, and application number GB1709987.0 filed June 22, 2017, each of which is incorporated herein by reference in its entirety.

[0117] In some embodiments, the non-negative pressure wound dressing may include an absorbent component for the wound dressing, comprising a wound contact layer containing gel-forming fibers bonded to a foam layer, the foam layer being directly bonded to the wound contact layer by an adhesive, a polymer-based melting layer, flame lamination, or ultrasound.

[0118] The absorbent component may be in the form of a sheet.

[0119] The wound contact layer may include a layer of woven, nonwoven, or knitted gel-like fabric.

[0120] The foam layer may be an open-cell foam or a closed-cell foam, and is generally an open-cell foam. The foam layer is a hydrophilic foam.

[0121] A wound dressing may include components that form an island in direct contact with the wound, surrounded by an adhesive that adheres the dressing to the wound. The adhesive may be a silicone or acrylic adhesive, and is generally a silicone adhesive.

[0122] The wound dressing may be covered with a film layer on the surface of the dressing furthest from the wound.

[0123] A more detailed description of this type of wound dressing is provided in European Patent No. 2498829, which is incorporated herein by reference in its entirety.

[0124] In some embodiments, non-negative pressure wound dressings may include multilayer wound dressings for use in wounds that generate high levels of exudate, characterized in that the dressing comprises a permeable layer having an MVTR of at least 300 gm2 in 24 hours, an absorbent core containing gel-forming fibers capable of absorbing and retaining exudate, a wound contact layer containing gel-forming fibers that deliver exudate to the absorbent core, and a keying layer positioned on the absorbent core, wherein the absorbent core and the wound contact layer restrict the lateral spread of exudate from the dressing to the wound area.

[0125] A wound dressing may have the capacity to handle at least 6 g (or 8 g to 15 g) of fluid per 10 cm² of the dressing in 24 hours.

[0126] Wound dressings may contain gel-forming fibers, which are chemically modified cellulosic fibers, in the form of a fabric. The fibers may include carboxymethylcellulose fibers, commonly sodium carboxymethylated cellulose fibers.

[0127] The wound dressing may include a wound contact layer with a lateral absorption rate of 5 mm to 40 mm per minute. The wound contact layer may have a fiber density of 25 gm² to 55 gm², such as 35 gm².

[0128] The absorbent core may have the ability to absorb at least 10 g / g of exudate, and typically the lateral absorption rate is less than 20 mm per minute.

[0129] The absorbent core may have a blend of up to 25% by weight of cellulosic fibers and 75% to 100% by weight of gel-forming fibers.

[0130] Alternatively, the absorbent core may have a blend of up to 50% by weight of cellulosic fibers and 50% to 100% by weight of gel-forming fibers. For example, the blend may be in the range of 50% by weight of cellulosic fibers and 50% by weight of gel-forming fibers.

[0131] The fiber density of the absorbent core may be 150 gm² to 250 gm², or approximately 200 gm².

[0132] When wet, wound dressings may shrink by less than 25% or less than 15% of their original size / dimensions.

[0133] The wound dressing may include a permeable layer, which is a foam. The permeable layer may be a polyurethane foam laminated onto a polyurethane film.

[0134] The wound dressing may include one or more layers selected from the group including a soluble drug film layer, an odor-absorbing layer, a diffusion layer, and an additional adhesive layer.

[0135] The wound dressing may be 2mm to 4mm thick.

[0136] Wound dressings can be characterized in that a keying layer bonds an absorbent core to an adjacent layer. In some embodiments, the keying layer may be located either on the wound-facing side or the non-wound-facing side of the absorbent core. In some embodiments, the keying layer is located between the absorbent core and the wound-contact layer. The keying layer is a polyamide web.

[0137] A more detailed description of this type of wound dressing is provided in European Patent No. 1718257, which is incorporated herein by reference in its entirety.

[0138] In some embodiments, the non-negative pressure wound dressing may be a compression bandage. Compression bandages are well known for use in the treatment of edema and other venous disorders, as well as lymphatic disorders of the lower extremities.

[0139] Compression bandage systems typically use multiple layers, including a padding layer between the skin and the compression layer (or multiple compression layers). Compression bandages can be useful for wounds, such as treating venous leg ulcers.

[0140] In some embodiments, the compression bandage may include a bandage system comprising an inner skin-facing layer and an elastic outer layer, the inner layer comprising a first layer of foam and a second layer of absorbent nonwoven web, and the inner and outer layers being sufficiently elongated so that they can be wrapped around the limbs of a patient. This type of compression bandage is disclosed in International Patent No. 99 / 58090, which is incorporated herein by reference in its entirety.

[0141] In some embodiments, the compression bandage system comprises a)(i) an elongated elastic base material,

[0142] (ii) an inner, elongated elastic bandage facing the skin, comprising an elongated foam layer, wherein the foam layer is attached to the surface of a substrate and extends across the surface of the substrate by at least 33% transversely and across the surface of the substrate by at least 67% longitudinally; and (b) an outer, elongated, adhesive elastic bandage, wherein the bandage has compressive force when extended, and in use, the foam layer of the inner bandage faces the skin and the outer bandage is on top of the inner bandage. This type of compression bandage is disclosed in International Patent No. 2006 / 110527, which is incorporated herein by reference in its entirety.

[0143] In some embodiments, other compression bandage systems, such as those disclosed in U.S. Patent No. 6,759,566 and U.S. Patent Application Publication No. 2002 / 0099318, are incorporated herein by reference in their entirety.

[0144] [Negative pressure wound dressings] In some embodiments, treatment of such wounds can be carried out using negative pressure wound therapy, in which decompression or negative pressure may be applied to the wound to facilitate and promote wound healing. It will also be understood that the wound dressings and methods disclosed herein may be applied to other parts of the body and are not necessarily limited to the treatment of wounds.

[0145] Embodiments of this disclosure will be understood to be generally applicable for use in topical negative pressure ("TNP (topical negative pressure)") therapy systems. Briefly, negative pressure wound therapy can help close and heal many forms of "difficult-to-heal" wounds by reducing tissue edema, promoting blood flow and granular tissue formation, and removing excess exudate, thereby reducing bacterial load (and therefore risk of infection). In addition, the treatment can reduce wound anxiety, leading to earlier healing. TNP therapy systems can also assist in the healing of surgically closed wounds by helping to remove fluid and stabilize tissue in parallel positions of closure. Further beneficial uses of TNP therapy can be found in grafts and flaps where removing excess fluid is important and it is required that the graft be in close proximity to the tissue to ensure tissue viability.

[0146] Negative pressure therapy can be used to treat open or chronic wounds that are too large to close spontaneously or that do not heal with the application of negative pressure to the wound site. Local negative pressure (TNP) therapy, or negative pressure wound therapy (NPWT), involves placing a fluid-impermeable or semi-permeable covering over the wound, using various means to seal the covering against the patient's surrounding tissue, and connecting a negative pressure source (such as a vacuum pump) to the covering in a manner that creates and maintains negative pressure directly beneath the covering. Such negative pressure is thought to promote wound healing by removing excess fluid, which may contain harmful cytokines or bacteria, while simultaneously facilitating granulation tissue formation at the wound site and supporting the normal inflammatory process in the body.

[0147] Some of the dressings used in NPWT include various types of materials and layers, such as gauze, pads, foam pads, or multilayer wound dressings. An example of a multilayer wound dressing is the PICO dressing, commercially available from Smith & Nephew, which includes a wound contact layer and a superabsorbent layer beneath a backing layer to provide a canister-free system for treating wounds in NPWT. Wound dressings can be sealed with a suction port, which provides a connection to a long tube that can be used to pump fluid from the dressing or to transfer negative pressure from a pump to the wound dressing. In addition, the RENASYS-F, RENASYS-G, RENASYS-AB, and RENASYS-F / AB, commercially available from Smith & Nephew, are further examples of NPWT wound dressings and systems. Another example of a multilayer wound dressing is the ALLEVYN Life dressing, commercially available from Smith & Nephew, which includes a moist wound environment dressing used to treat wounds without using negative pressure.

[0148] As used herein, a reduced pressure or negative pressure level, e.g., -X mmHg, represents a pressure level relative to normal ambient pressure, which may correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -X mmHg reflects an absolute pressure that is X mmHg lower than 760 mmHg, or in other words, an absolute pressure of (760-X) mmHg. In addition, negative pressures "lower" or "smaller" than X mmHg correspond to pressures closer to atmospheric pressure (e.g., -40 mmHg is lower than -60 mmHg). Negative pressures "higher" or "larger" than -X mmHg correspond to pressures further away from atmospheric pressure (e.g., -80 mmHg is higher than -60 mmHg). In some embodiments, a local ambient atmospheric pressure is used as a reference point, and such a local pressure does not necessarily have to be, for example, 760 mmHg.

[0149] The negative pressure range in some embodiments of this disclosure can be about -80 mmHg, or about -20 mmHg to -200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure, which can be 760 mmHg. Therefore, -200 mmHg would be substantially about 560 mmHg. In some embodiments, the pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges of -75 mmHg or less, -80 mmHg or less, or above -80 mmHg may be used. In other embodiments, pressure ranges below -75 mmHg may be used. As an alternative, pressure ranges of approximately -100 mmHg or even above -150 mmHg may be supplied by the negative pressure device.

[0150] In some embodiments of the wound closure apparatus described herein, increased wound contraction may lead to increased tissue expansion in the surrounding wound tissue. This effect may be amplified, in some cases, by changing the force applied to the tissue in conjunction with an increase in the tensile force applied to the wound by an embodiment of the wound closure apparatus, for example, by changing the negative pressure applied to the wound over time. In some embodiments, the negative pressure may be changed over time, for example, using a sine wave, a square wave, or in synchronization with one or more physiological indicators of the patient (such as heart rate). Further disclosures relating to the foregoing can be found in U.S. Patent No. 8,235,955, entitled “Wound treatment apparatus and method,” issued on 7 August 2012, and U.S. Patent No. 7,753,894, entitled “Wound cleansing apparatus with stress,” issued on 13 July 2010. The disclosures of both of these patents are incorporated herein by reference in their entirety.

[0151] Embodiments of wound dressings, wound dressing components, wound treatment apparatuses and methods described in this specification may also be used in combination with, or in addition to, those described in "APPARATUSES AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY," filed on 22 May 2013 under International Application No. PCT / IB2013 / 001469 and published on 28 November 2013 under International Publication No. 2013 / 175306A2, and "WOUND DRESSING AND METHOD OF TREATMENT," filed on 30 January 2015 under U.S. Patent Application No. 14 / 418,908 and published on 9 July 2015 under U.S. Patent Application Publication No. 2015 / 0190286A1, the disclosures thereof being incorporated herein by reference in their entirety. Embodiments of wound dressings, wound dressing components, wound treatment devices, and methods described herein may also be used in combination with, or in addition to, those described herein, including further details relating to embodiments of wound dressings, components and principles of wound dressings, and materials used in wound dressings. These embodiments are incorporated herein by reference.

[0152] In addition, some embodiments relating to TNP wound treatment, including wound dressings, in combination with the pumps or associated electronic devices described herein may also be used in combination with, or in addition to, those described in "REDUCED PRESSURE APPARATUS AND METHODS," filed on 26 April 2016 as International Application PCT / EP2016 / 059329 and published on 3 November 2016 as International Publication 2016 / 174048, the disclosure of which is incorporated by reference throughout this specification.

[0153] [Overview of the NPWT System] Figure 1A shows an embodiment of a negative pressure or decompression wound healing (or TNP) system 100, which includes a wound filler 130 placed inside a wound cavity 110, and the wound cavity is sealed by a wound cover 120. The wound filler 130 combined with the wound cover 120 may be referred to as a wound dressing. One or more luminous tubes or conduits 140 connect the wound cover 120 to a pump assembly 150 configured to supply decompression pressure. The wound cover 120 can be in fluid communication with the wound cavity 110. In some embodiments of the systems disclosed herein, such as the embodiment shown in Figure 1, the pump assembly may be a canisterless pump assembly (meaning that exudate is collected in the wound dressing or carried through the tube 140 to collect at another location). However, some embodiments of the pump assembly disclosed herein may include or be configured to support a canister. Additionally, in some embodiments of the systems disclosed herein, some embodiments of the pump assembly may be mounted to, supported by, or adjacent to a covering material.

[0154] The wound filler 130 can be any suitable type, such as a hydrophilic or hydrophobic foam, gauze, or an inflatable bag. The wound filler 130 can be fitted to the wound cavity 110 so that it substantially fills the cavity. The wound cover 120 can provide a substantially fluid-impermeable seal covering the wound cavity 110. The wound cover 120 may have an apical and a basal side, the basal side sealing the wound cavity 110 adhesively (or by any other suitable method). The conduit 140 or lumen disclosed herein, or some other conduit or lumen, may be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0155] Some embodiments of the wound cover 120 may have a port (not shown) configured to receive the end of a conduit 140. For example, the port could be a Renasys Soft Port, available from Smith & NepHew. In other embodiments, the conduit 140 may pass through or be beneath the wound cover 120 to supply decompression pressure to the wound cavity 110, in other ways, to maintain a desired level of decompression pressure within the wound cavity. The conduit 140 can be any preferred article configured to provide at least a substantially sealed fluid passage between the pump assembly 150 and the wound cover 120 to supply the decompression pressure provided by the pump assembly 150 to the wound cavity 110.

[0156] The wound cover 120 and wound filler 130 may be supplied as a single article or as a single, integrated unit. In some embodiments, the wound cover may be considered the wound dressing itself, without the provision of wound filler. The wound dressing may then be connected via a conduit 140 to a negative pressure source, such as a pump assembly 150. The pump assembly 150 may be miniaturized and portable, but larger conventional pumps of that type may also be used.

[0157] The wound cover 120 may be placed over the wound site to be treated. The wound cover 120 may form a substantially sealed cavity or enclosure covering the wound site. In some embodiments, the wound cover 120 may be configured to have a film with high water vapor permeability to allow evaporation of excess fluid, and may also have a superabsorbent material contained therein to safely absorb wound exudate. Throughout this specification, it will be understood that we will be referring to wounds. In this regard, it should be understood that the term wound is interpreted broadly and includes open and closed wounds in which the skin is torn, cut or perforated, or in which trauma causes a contusion, or any other surface or condition or defect on the patient's skin, or any other that would benefit from decompression therapy. Thus, a wound is broadly defined as any damaged area of ​​tissue in which fluid may or may not be generated. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical incisions and other incisions, subacute and dehiscent wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers. The components of the TNP system described herein may be particularly suitable for incisional wounds that exude small amounts of wound fluid.

[0158] Some embodiments of the system are designed to operate without using an exudate canister. Some embodiments may be configured to support an exudate canister. In some embodiments, configuring the pump assembly 150 and the tube 140 so that the tube 140 can be quickly and easily removed from the pump assembly 150 may facilitate or improve the process of replacing the covering or pump, if necessary. Some embodiments of the pump disclosed herein may be configured to have any preferred connection between the tube and the pump.

[0159] The pump assembly 150 may be configured in some implementations to supply a negative pressure of approximately -80 mmHg, or approximately -20 mmHg to 200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure, meaning that -200 mmHg may be approximately 560 mmHg in practical terms. The pressure range may be between approximately -40 mmHg and -150 mmHg. Alternatively, pressure ranges of -75 mmHg or less, -80 mmHg or less, or above -80 mmHg may be used. Also, a pressure range below -75 mmHg may be used. Alternatively, a pressure range of approximately -100 mmHg or even above 150 mmHg may be supplied by the pump assembly 150.

[0160] During operation, the wound filler 130 is inserted into the wound cavity 110, and the wound cover 120 is positioned to seal the wound cavity 110. The pump assembly 150 provides the wound cover 120 with a negative pressure source that is delivered to the wound cavity 110 via the wound filler 130. Fluid (e.g., wound exudate) can be drawn through the conduit 140 and stored in a canister. In some embodiments, the fluid is absorbed by the wound filler 130 or one or more absorbent layers (not shown).

[0161] Wound dressings that may be used with the pump assembly and other embodiments of this application include Renasys-F, Renasys-G, Renasys AB, and Pico dressings available from Smith & NepHew. Further descriptions of such wound dressings and other components of negative pressure wound treatment systems that may be used with the pump assembly and other embodiments of this application are found in U.S. Patent Publications 2011 / 0213287, 2011 / 0282309, 2012 / 0116334, 2012 / 0136325, and 2013 / 0110058, which are incorporated by reference in their entirety. In other embodiments, other suitable wound dressings may be used.

[0162] [Overview of wound dressings] Figure 1B illustrates a cross-sectional view through a wound dressing 155 according to several embodiments. Figure 1B also illustrates a fluid connector 160 according to several embodiments. The wound dressing 155 may be similar to the wound dressing described in International Patent Publication 2013175306A2, which is incorporated in whole by reference. Alternatively, the wound dressing 155 may be any combination of features of any embodiment of the wound dressing disclosed in the specification, or any number of features of the embodiments of the wound dressing disclosed herein, and may be placed over a wound site to be treated. The wound dressing 155 may be positioned to form a sealed cavity over the wound, such as a wound cavity 110. In some embodiments, the wound dressing 155 preferably includes a backing layer 220 attached to an uppermost layer or covering layer, or any wound contact layer 222, which are described in more detail below. These two layers 220, 222 may be joined or sealed together to define an internal space or chamber. This internal space or chamber may include additional structures that can be adapted to distribute or transmit negative pressure and to store wound exudate and other fluids removed from the wound, as well as other functions that will be described in more detail below. Examples of such structures described below include a permeable layer 226 and an absorbent layer 221.

[0163] As used herein, the upper layer, top layer, or upper layer refers to the layer furthest from the surface of the skin or wound while the dressing is in use and positioned over the wound. Conversely, the lower layer, bottom layer, bottom layer, or lower layer refers to the layer closest to the surface of the skin or wound while the dressing is in use and positioned over the wound.

[0164] The wound contact layer 222 may be a polyurethane layer, a polyethylene layer, or other flexible layer perforated by, for example, a hot-pin process, a laser ablation process, or an ultrasonic process, or by several other methods, or otherwise made permeable to liquids and gases. The wound contact layer 222 has a lower surface 224 (e.g., facing the wound) and an upper surface 223 (e.g., facing outward from the wound). Perforations 225 may include through-holes in the wound contact layer 222, allowing fluid to flow through the layer 222. The wound contact layer 222 helps prevent tissue infiltration into other materials of the wound dressing. In some embodiments, the perforations are small enough to satisfy this requirement while still allowing fluid to flow through the perforations. For example, perforations formed as slits or holes with dimensions ranging from 0.025 mm to 1.2 mm are considered small enough to help prevent tissue infiltration into the wound dressing while allowing wound exudate to flow into the dressing. In some configurations, the wound contact layer 222 may help maintain the integrity of the entire dressing 155 while also creating an airtight seal around the absorbent pad to maintain negative pressure on the wound. In some embodiments, the wound contact layer is configured to allow unidirectional or substantially unidirectional or unidirectional flow of fluid through the wound contact layer when negative pressure is applied to the wound. For example, the wound contact layer allows fluid to flow out of the wound through the wound contact layer but not back into the wound. In certain cases, perforations in the wound contact layer are configured to allow such unidirectional or unidirectional flow of fluid through the wound contact layer.

[0165] Some embodiments of the wound contact layer 222 may also act as carriers for optional lower and upper adhesive layers (not shown). For example, a lower pressure-sensitive adhesive may be provided on the lower surface 224 of the wound dressing 155, while an upper pressure-sensitive adhesive layer may be provided on the upper surface 223 of the wound contact layer. The pressure-sensitive adhesive, which may be a silicone, hot-melt, hydrophilic colloid, or acrylic-based adhesive, or other such adhesives, may be formed on both sides of the wound contact layer, on one of the optionally selected sides, or not on either side of the wound contact layer. Utilizing a lower pressure-sensitive adhesive layer may help to adhere the wound dressing 155 to the skin around the wound site. In some embodiments, the wound contact layer may include a perforated polyurethane film. The lower surface of the film may be provided with a silicone pressure-sensitive adhesive, and the upper surface may be provided with an acrylic pressure-sensitive adhesive, thereby helping the dressing maintain its integrity. In some embodiments, adhesive layers may be provided on both the upper and lower surfaces of the polyurethane film layer, and all three layers may be perforated.

[0166] A porous material layer 226 may be positioned above the wound contact layer 222. This porous or permeable layer 226 allows fluids, including liquids and gases, to permeate away from the wound site into the upper layers of the wound dressing. In particular, the permeable layer 226 ensures that the outside air channels can be maintained to transmit negative pressure throughout the wound area, even when the absorbent layer has absorbed a considerable amount of exudate. The layer 226 should preferably remain open under the normal pressure that will be applied during negative pressure wound therapy, as described above, so that the entire wound site receives equal negative pressure. The layer 226 may be formed from a material having a three-dimensional structure. For example, knitted or woven spacer fabrics (e.g., Baltex 7970 weft-knit polyester) or nonwoven fabrics may be used.

[0167] In some embodiments, the permeable layer 226 includes a 3D polyester spacer fabric layer comprising an uppermost layer (i.e., the layer distal to the wound bed during use) which is 84 / 144 woven polyester, a lowermost layer (i.e., the layer placed close to the wound bed during use) which is 10-denier flat polyester, and a third layer formed sandwiched between these two layers, which is an area defined by knitted polyester viscose, cellulose, or similar monofilament fibers. Other materials and fibers of other linear mass densities may, of course, also be used.

[0168] Throughout this disclosure, while references are made to monofilament fibers, it will be understood that, of course, multifilament alternatives may be used. Therefore, the uppermost spacer fabric has more filaments in a single thread used to form it than the number of filaments that make up the thread used to form the lowermost spacer fabric layer.

[0169] This difference in the number of filaments in the spaced layers helps control the flow of moisture throughout the permeable layer. Specifically, by increasing the number of filaments in the top layer, i.e., by making the top layer from a thread with more filaments than the thread used in the bottom layer, fluid tends to be absorbed more along the top layer than along the bottom layer. During use, this difference causes the fluid to be drawn away from the wound bed and into the central region of the dressing, where the absorbent layer 221 helps to contain the fluid or draws it forward on its own towards the dressing layer that can release the fluid.

[0170] In some embodiments, to improve the flow of liquid across the permeable layer 226 (i.e., perpendicular to the channel region formed between the top and bottom spacer layers), the 3D fabric may be treated with a dry cleaning agent (but not limited to perchloroethylene) to help remove any previously used industrial products, such as mineral oils, greases, or waxes, that may interfere with the hydrophilic ability of the permeable layer. Subsequently, the 3D spacer fabric may proceed to an additional manufacturing step in which it is washed with a hydrophilic agent (but not limited to 30 g / l Feran Ice, commercially available from Rudolph Group). This process step helps ensure that the surface tension of the material is low enough that liquids such as water can penetrate the fabric as soon as they come into contact with the 3D knitted fabric. This step also helps to control the flow of any liquid insult component of any exudates.

[0171] An absorbent material layer 221 can be provided on top of the permeable layer 226. The absorbent material, which may include a foam or nonwoven natural or synthetic material and optionally include a superabsorbent material, forms a reservoir for the fluid, specifically the liquid to be removed from the wound site. In some embodiments, the layer 221 may also help to draw the fluid towards the backing layer 220.

[0172] The material of the absorbent layer 221 may also prevent the fluid collected in the wound dressing 155 from flowing freely within the dressing and may act to contain any fluid collected within the dressing. The absorbent layer 221 also helps distribute the fluid throughout the layer by suction, drawing the fluid away from the wound site and storing it throughout the absorbent layer. This helps prevent aggregation within the absorbent layer. The volume of the absorbent material must be sufficient to control the rate at which wound exudate flows when negative pressure is applied. Since the absorbent layer experiences negative pressure during use, the material of the absorbent layer is selected to absorb fluid under such conditions. There are several materials that can absorb fluid under negative pressure, such as superabsorbent materials. The absorbent layer 221 may typically be manufactured from ALLEVYN® foam Freudenberg 114-224-4 or Chem-Posite® 11C-450. In some embodiments, the absorbent layer 221 may include a composite material comprising superabsorbent powder, fibrous material such as cellulose, and binding fibers. In some embodiments, the composite material is a thermally bonded composite material of airlaid.

[0173] In some embodiments, the absorbent layer 221 is a layer of nonwoven cellulose fibers having a superabsorbent material in the form of dry particles dispersed throughout. The use of cellulose fibers introduces a high-speed suction element that helps to quickly and evenly distribute the liquid absorbed by the coating. Arranging a large number of twisted fibers in parallel leads to a strong capillary action of the fiber pad that helps to distribute the liquid. In this way, the liquid is efficiently supplied to the superabsorbent material. The suction action also helps to bring the liquid into contact with the upper cover layer, which helps to increase the evaporation rate of the coating.

[0174] An opening, hole, or orifice 227 can be provided in the backing layer 220 to allow negative pressure to be applied to the covering material 155. In some embodiments, a fluid connector 160 is mounted or sealed to the top of the backing layer 220 over the orifice 227 made in the covering material 155, and transmits negative pressure through the orifice 227. A long tube may be connected at a first end to the fluid connector 160 and at a second end to a pump unit (not shown) to allow fluid to be drawn from the covering material. If the fluid connector is bonded to the top layer of the wound dressing, the long tube may be connected at the first end of the fluid connector such that the tube or conduit extends away from the fluid connector parallel to or substantially toward the top surface of the covering material. The fluid connector 160 may be bonded and sealed to the backing layer 220 using an adhesive such as acrylic, cyanoacrylate, epoxy, UV-curable, or hot-melt adhesive. The fluid connector 160 may be formed from a soft polymer having a hardness of 30 to 90 on the Shore A scale, such as polyethylene, polyvinyl chloride, silicone, or polyurethane. In some embodiments, the fluid connector 160 may be made from a soft material or a suitable material.

[0175] In some embodiments, the absorption layer 221 includes at least one through-hole 228 positioned beneath the fluid connector 160. In some embodiments, the through-hole 228 may be the same size as, or larger than, the opening 227 in the backing layer. As shown in Figure 1B, a single through-hole may be used to create the opening that forms the basis of the fluid connector 160. It will be understood that multiple openings may be used as alternatives. In addition, if two or more ports are to be utilized according to a particular embodiment of the disclosure, one or more openings may be made in the absorption layer and the obscuration layer, aligned with each fluid connector. Although not essential to the particular embodiment of the disclosure, using through-holes in the superabsorbent layer may provide unobstructed fluid channels, especially when the absorption layer is near saturation.

[0176] An opening or through-hole 228 may be provided in the absorbent layer 221 below the orifice 227, as illustrated in Figure 1B, such that the orifice is directly connected to the permeable layer 226. This allows the negative pressure applied to the fluid connector 160 to be transmitted to the permeable layer 226 without passing through the absorbent layer 221. This ensures that the negative pressure applied to the wound site is not obstructed by the absorbent layer when the absorbent layer absorbs wound exudate. In other embodiments, the opening may not be provided in the absorbent layer 221, or alternatively, multiple openings may be provided below the orifice 227. In further alternative embodiments, an additional layer, such as another permeable layer, or an obscuring layer, such as that described in International Patent Application Publication No. 2014020440, which is incorporated in whole by reference, may be provided above the absorbent layer 221 and below the backing layer 220.

[0177] The backing layer 220 is impermeable to gases but permeable to water vapor and may extend across the width of the wound dressing 155. For example, the backing layer 220 may be a polyurethane film (e.g., Elastollan SP9109) with a pressure-sensitive adhesive on one side, and is impermeable to gases, and therefore acts to cover the wound and seal the wound cavity on which the wound dressing is placed. In this way, an effective chamber is created between the backing layer 220 and the wound site, on which negative pressure can be established. The backing layer 220 can be sealed to the wound contact layer 222 in the boundary region around the outer periphery of the dressing, ensuring that air is drawn through the boundary region, for example by adhesive or welding techniques. The backing layer 220 protects the wound from external bacterial contamination (bacterial barrier) and allows fluid from the wound exudate to move through the layer and evaporate from the outer surface of the film. The backing layer 220 may comprise two layers: a polyurethane film and an adhesive pattern spread across the film. The polyurethane film may be permeable to water and may be made from a material whose water permeability increases when wet. In some embodiments, when the backing layer is wet, its permeability increases. The permeability of a wet backing layer may be up to approximately 10 times that of a dry backing layer.

[0178] The absorbent layer 221 may have a larger area than the permeable layer 226 so that the absorbent layer overlaps with the edge of the permeable layer 226, thereby ensuring that the permeable layer does not come into contact with the backing layer 220. This provides an outer channel of the absorbent layer 221 that is in direct contact with the wound contact layer 222, which helps in the more rapid absorption of exudate into the absorbent layer. Furthermore, this outer channel ensures that fluid does not accumulate around the periphery of the wound cavity, which would otherwise seep out from the sealing around the dressing and lead to leakage. As shown in Figure 1B, the absorbent layer 221 may define a boundary or boundary region smaller than the periphery of the backing layer 220 so that the boundary or boundary region is defined between the edge of the absorbent layer 221 and the edge of the backing layer 220.

[0179] As shown in Figure 1B, one embodiment of the wound dressing 155 includes an opening 228 in the absorbent layer 221 located below the fluid connector 160. During use, for example, when negative pressure is applied to the dressing 155, the portion of the fluid connector facing the wound may be in contact with the permeable layer 226, and thus can help transmit negative pressure to the wound site even when the absorbent layer 221 is filled with wound fluid. In some embodiments, a backing layer 220 may be at least partially adhered to the permeable layer 226. In some embodiments, the opening 228 is at least 1 to 2 mm larger than the diameter of the portion of the fluid connector 11 facing the wound or the orifice 227.

[0180] For example, in embodiments involving a single fluid connector 160 and a through-hole, it may be preferable that the fluid connector 160 and the through-hole be positioned off-center. In such a location, it may be possible to position the covering 155 on the patient so that the fluid connector 160 is elevated relative to the rest of the covering 155. Such positioning may reduce the likelihood of the fluid connector 160 and the filter 214 coming into contact with the wound fluid, which could prematurely occlude the filter 214 in order to reduce the transmission of negative pressure to the wound site.

[0181] Referring here to the fluid connector 160, some embodiments include a sealing surface 216, a bridge 211 having a proximal end (closer to the negative pressure source) and a distal end 140, and a filter 214. The sealing surface 216 may form an applicator that seals to the uppermost surface of the wound dressing. In some embodiments, the bottom layer of the fluid connector 160 may include the sealing surface 216. The fluid connector 160 may further include, in some embodiments, an upper surface defined by a separate upper layer of the fluid connector, spaced perpendicularly from the sealing surface 216. In other embodiments, the top and bottom surfaces may be formed from the same piece of material. In some embodiments, the sealing surface 216 may have at least one opening 229 therein to communicate with the wound dressing. In some embodiments, the filter 214 may be positioned across the opening 229 of the sealing surface or across the entire opening 229. The sealing surface 216 may be configured to seal the fluid connector to the cover layer of the wound dressing and may include adhesive or welded joints. In some embodiments, the sealing surface 216 may be positioned above the orifice of the cover layer, with a spacer element 215 configured to create a gap between the filter 214 and the permeable layer 226. In other embodiments, the sealing surface 216 may be positioned above the orifice of the cover layer and the opening of the absorbent layer 220, allowing the fluid connector 160 to provide airflow through the permeable layer 226. In some embodiments, the bridge 211 may comprise a first fluid passage 212 communicating with a negative pressure source, the first fluid passage 212 comprising a porous material which may be the same as or different from the porous layer 226 described above, such as a 3D knitted material. The bridge 211 may be enclosed by at least one flexible film layer 208, 210 having a proximal and distal end and configured to surround the first fluid passage 212, the distal end of the flexible film connecting to the sealing surface 216. The filter 214 is configured to substantially prevent wound exudate from entering the bridge, and the spacer element 215 is configured to prevent the fluid connector from contacting the permeable layer 226. These elements are described in more detail below.

[0182] Some embodiments may further include an optional second fluid passage located above the first fluid passage 212. For example, some embodiments may provide an air leak, which may be located at the proximal end of the uppermost layer and configured to provide an air path to the first fluid passage 212 and the covering material 155, similar to the suction adapter described in U.S. Patent No. 8,801,685, which is incorporated by reference in whole.

[0183] In some embodiments, the fluid passage 212 is constructed from a flexible, standard material that allows fluid to pass through even when the spacer is twisted or folded. Suitable materials for the fluid passage 212 include, but are not limited to, foams including open-cell foams such as polyethylene or polyurethane foam, meshes, 3D knits, nonwoven materials, and fluid channels. In some embodiments, the fluid passage 212 may be constructed from materials similar to those described above with respect to the permeable layer 226. Advantageously, such materials used for the fluid passage 212 can not only increase patient comfort but also provide greater torsional resistance, allowing the fluid passage 212 to still move fluid from the wound towards the negative pressure source even while twisting or bending.

[0184] In some embodiments, the fluid passage 212 may consist of a wicking fabric, such as a knitted or woven spacer fabric (a polyester knitted 3D fabric Baltex 7970® or Gehring 879®), or a nonwoven fabric. Selected materials may be placed to guide wound exudate away from the wound, to transmit negative pressure or discharged air to the wound site, and may also provide some torsional or occluding resistance to the fluid passage 212. In some embodiments, the wicking fabric may have a three-dimensional structure that, in some cases, may help in the suction of fluid or the transmission of negative pressure. In certain embodiments, in embodiments including a wicking fabric, these materials can remain open and still transmit negative pressure to the wound area, for example, under the normal pressures used in negative pressure therapy between -40 and -150 mmHg. In some embodiments, the wicking fabric may comprise several layers of material stacked or laminated on top of each other, which in some cases may be useful in preventing the fluid passage 212 from collapsing under negative pressure conditions. In other embodiments, the wicking fabric used for the fluid passage 212 may be between 1.5 mm and 6 mm thick, more preferably between 3 mm and 6 mm thick, and may consist of one or more individual wicking fabric layers. In other embodiments, the fluid passage 212 may be between 1.2 and 3 mm thick, preferably thicker than 1.5 mm. In some embodiments, for example, a suction adapter used with a dressing that holds fluids such as wound exudate, a hydrophobic layer may be used for the fluid passage 212, allowing only gas to move through the fluid passage 212. In addition, as previously described, the materials used in the system can be conforming and soft, which may help avoid pressure ulcers and other complications that may result from wound treatment systems that apply pressure to the patient's skin.

[0185] In some embodiments, the filter element 214 is provided to be impermeable to liquids but permeable to gases, acting as a liquid barrier to ensure that the liquid cannot leak out of the wound dressing 155. The filter element 214 may also function as a bacterial barrier. Typically, the pore size is 0.2 μm. Suitable materials for the filter material of the filter element 214 include 0.2 micron Gore® extended PTFE, PALL Versapore® 200R, and Donaldson® TX6628 from the MMT range. Larger pore sizes may also be used, but these may require a secondary filter layer to ensure complete containment of biological contamination. Since wound fluids contain lipids, it is preferable, though not essential, to use an oleophobic filter membrane, such as 1.0 micron MMT-332 before 0.2 micron MMT-323. This prevents lipids from blocking the hydrophobic filter. The filter element may be attached to or sealed in a port or cover film above the orifice. For example, the filter element 214 may be molded onto the fluid connector 160, or, but is not limited to, it may be bonded to either or both the top of the coating layer and the bottom of the suction adapter 160 using an adhesive such as a UV-curing adhesive.

[0186] It will be understood that other types of materials may be used for the filter element 214. More broadly, a microporous membrane, which is a thin, flat polymer material, can be used, containing billions of microscopic pores. Depending on the membrane chosen, these pores can range in size from 0.01 micrometers to larger than 10 micrometers. Microporous membranes are available in both hydrophilic (water filtering) and hydrophobic (water-repellent) forms. In some embodiments, the filter element 214 includes a support layer and an acrylic copolymer membrane formed on the support layer. In some embodiments, the wound dressing 155 according to certain embodiments uses a microporous hydrophobic membrane (MHM). Numerous polymers can be used to form the MHM. For example, the MHM may be formed from one or more of PTFE, polypropylene, PVDF, and acrylic copolymers. All of these arbitrary polymers can be treated to obtain specific surface properties, which may be both hydrophobic and oleophobic. These will repel liquids with low surface tension, such as multivitamin infusions, lipids, surfactants, oils, and organic solvents.

[0187] MHMs block liquids while allowing air to flow through the membrane. MHMs are also highly efficient air filters that eliminate potentially infectious aerosols and particles. Single MHM pieces are well-known as an alternative to mechanical valves or vents. Therefore, incorporating MHMs can reduce product assembly costs and improve profits and the cost / benefit ratio to patients.

[0188] The filter element 214 may also include odor-absorbing materials such as activated carbon, carbon fiber cloth, or Vitec Carbotec-RT Q2003073 foam, or similar materials. For example, the odor absorbent may form a layer of the filter element 214 or be sandwiched between hydrophobic microporous membranes within the filter element. Thus, the filter element 214 allows gas to be discharged through the orifice. However, liquids, particulate matter, and pathogens are contained within the covering material.

[0189] The wound dressing 155 may include a spacer element 215 in conjunction with the fluid connector 160 and the filter 214. By adding such a spacer element 215, the fluid connector 160 and the filter 214 can be supported so as not to be in direct contact with the absorbent layer 220 or the permeable layer 226. The absorbent layer 220 may also act as an additional spacer element to bring the filter 214 into contact with the permeable layer 226. Thus, this configuration can minimize contact between the filter 214 and the permeable layer 226 and the wound fluid during use.

[0190] Similar to the embodiments of wound dressings described above, some wound dressings include a perforated wound contact layer with a silicone adhesive on the skin contact surface and an acrylic adhesive on the back surface. Above this bordered layer is a permeable layer or a 3D spacer fabric pad. Above the permeable layer is an absorbent layer. The absorbent layer may include a superabsorbent nonwoven (NW) pad. The absorbent layer may be in contact with the permeable layer for approximately 5 mm beyond its periphery. The absorbent layer may have an opening or through-hole directed toward one end. The opening may be approximately 10 mm in diameter. Above the permeable and absorbent layers is a backing layer. The backing layer may be a high water vapor permeability (MVTR) film, which is a pattern coated with acrylic adhesive. The high MVTR film and wound contact layer enclose the permeable and absorbent layers, creating a periphery boundary of approximately 20 mm. The backing layer may have a 10 mm opening that overlaps the opening in the absorbent layer. A fluid connector may be connected above the hole, comprising a liquid-impermeable, gas-permeable semi-permeable membrane (SPM) or filter that overlaps the aforementioned opening.

[0191] Wound dressing with sensor Wound dressings incorporating multiple sensors can be used to monitor the characteristics of a wound as it heals. Collecting data from wounds that heal well and those that do not can provide useful insights into identifying metrics to indicate whether a wound is on the healing trajectory.

[0192] In some implementations, several sensor technologies may be used in a wound dressing or in one or more components that form part of an overall wound dressing device. For example, as shown in Figures 2 and 3D, which illustrate wound dressings 250 and 320 having sensor arrays according to some embodiments, one or more sensors may be incorporated on or into the wound contact layer, which may be a perforated wound contact layer as shown in Figure 3D. Although the wound contact layer in Figures 2 and 3D is shown to have a rectangular shape, it will be understood that the wound contact layer may have other shapes, such as rectangular, circular, or elliptical. In some embodiments, the sensor-integrated wound contact layer is provided as an individual material layer placed over the wound area and can then be covered by a wound dressing device, components of the wound dressing device, such as gauze, foam or other wound packing material, superabsorbent layer, drape, or a fully integrated dressing such as Pico or Allevyn Life dressings. In other embodiments, the sensor-integrated wound contact layer may be part of a single-unit dressing, as described herein.

[0193] A sensor-integrated wound contact layer can be positioned in contact with a wound, allowing fluids to pass through the contact layer with little to no damage to the tissue within the wound. The sensor-integrated wound contact layer can be made from a flexible material such as silicone and may incorporate antimicrobial agents or other therapeutic agents known in the art. In some embodiments, the sensor-integrated wound contact layer may incorporate an adhesive for bonding to wet or dry tissue. In some embodiments, the sensor, or sensor array, may be incorporated into or encapsulated within other components of the wound dressing, such as the absorbent or spacer layers described above.

[0194] As shown in Figures 2 and 3D, five sensors may be used, including, for example, sensors for temperature (e.g., 25 thermistor sensors, 5x5 array, pitch ~20 mm), oxygen saturation or SpO2 (e.g., 4 or 5 SpO2 sensors, a single straight line from the center to the edge of the wound contact layer, pitch 10 mm), tissue color (e.g., 10 optical sensors, 2x5 array, pitch ~20 mm, not all 5 sensors in each row of the array need to be aligned), pH (e.g., by measuring the color of a pH-sensitive pad, optionally using the same optical sensors as for tissue color), and conductivity (e.g., 9 conductive contacts, 3x3 array, pitch ~40 mm). As shown in Figure 3A, the SpO2 sensors may be arranged in a single straight line from the center or near the center of the wound contact layer to the edge of the wound contact layer. The straight line of the SpO2 sensors may allow the sensors to obtain measurements in the middle of the wound, at the edge or in the wound, or on intact skin, so that the sensors can measure changes between various regions. In some embodiments, the wound contact layer or sensor array may be larger than the size of the wound to cover not only the entire surface area of ​​the wound but also the surrounding intact skin. A larger wound contact layer and / or sensor array, and multiple sensors, can provide more information about the wound area than if sensors were placed only at the center of the wound or one point at a time within the area.

[0195] Sensors can be incorporated onto a flexible circuit substrate formed from flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), and polyethylene naphthalate (PEI), along with various fluoropolymers (FEP) and copolymers, or any material known in the art. Sensor arrays can be incorporated into a two-layer flexible circuit. In some embodiments, the circuit substrate may be a multilayer flexible circuit substrate. In some embodiments, these flexible circuits can be incorporated into any layer of a wound dressing. In some embodiments, the flexible circuits can be incorporated into a wound contact layer. For example, the flexible circuits can be incorporated into a wound contact layer similar to the wound contact layer described with reference to Figure 1B. The wound contact layer may have cutouts or slits that protrude from the lower surface of the wound contact layer and allow one or more sensors to make direct contact with the wound area.

[0196] In some embodiments, the sensor-integrated wound contact layer may include first and second wound contact layers, each comprising a flexible circuit board sandwiched between two layers of wound contact layer material. The first wound contact layer has a lower surface intended to contact the wound and an upper surface intended to contact the flexible circuit board. The second wound contact layer has a lower surface intended to contact the flexible circuit board and an upper surface intended to contact one or more components that form part of a wound dressing or an entire wound dressing assembly. The upper surface of the first wound contact layer and the lower surface of the second wound contact layer may be bonded together with the flexible circuit board sandwiched between the two layers.

[0197] In some embodiments, one or more sensors on a flexible circuit board may be completely sealed or covered by a wound contact layer to prevent contact with moisture or fluid in the wound. In some embodiments, the first wound contact layer may have cutouts or slits that protrude from the lower surface and allow one or more sensors to make direct contact with the wound area. For example, one or more SpO2 sensors as shown in Figure 3D are shown protruding from the bottom surface of the wound contact layer. In some embodiments, the SpO2 sensors may be placed directly on the lower surface of the first wound contact layer. Some or all of the sensors and electrical or electronic components may be embedded or encapsulated in a polymer, such as a silicone or epoxy-based polymer (e.g., to make them waterproof or liquid-proof). Encapsulation with a polymer can prevent fluid ingress and chemical leaching from the components. In some embodiments, the wound contact layer material may seal the components to prevent water ingress and chemical leaching.

[0198] In some embodiments, three components, including a sensor array, a control or processing module, and software, may be used to collect and process wound-related information. These three components are described in more detail herein.

[0199] Figure 3A shows a flexible sensor array circuit board 300, including a sensor array portion 301, a tail portion 302, and a connector pad end portion 303, according to several embodiments. The sensor array portion 301 may include sensors and associated circuits. The sensor array circuit board 300 may include a long tail portion 302 extending from the sensor array portion 301. The connector pad end portion 303 may be connectable to a control module or other processing unit to receive data from the sensor array circuit. The long tail portion 302 may allow the control module to be positioned far from the wound, for example, in a more convenient location away from the wound.

[0200] Figure 3B shows embodiments of a flexible circuit board having four different sensor array geometric shapes 301A, 301B, 301C, and 301D according to several embodiments. The illustrated embodiments include tail portions 302A, 302B, 302C, and 302D. In some embodiments, the four different sensor array shapes can be implemented in the flexible circuit. Figure 3B shows four different sensor array forms and configurations, but designs 301B and 302B also include a connector pad end portion 303 configured to provide an electrical or electronic connection between the sponsor array 301B and the control module. One or more of the designs 301A, 301C, or 301D include a connector pad end portion, such as portion 303, to enable the flexible circuit board 301A, 301C, or 301D to communicate with the control module or other processing unit. In some embodiments, the sensor array communicates wirelessly with the control module, and the tail portion may be omitted.

[0201] Figure 3C shows a more detailed view of the sensor array portion 301B of the sensor array design shown in Figure 3B. In one or more embodiments of Figure 2 or Figures 3A-3D, the sensor array portion may include multiple portions that extend either near the periphery of a wound dressing component, such as a wound contact layer, or inward from the outer edge of the wound dressing component. For example, the illustrated embodiment includes multiple linear extensions that are parallel to the edge of the wound dressing component and, in some embodiments, may follow the entire periphery of the wound dressing component. In some embodiments, the sensor array portion may include a first set of parallel linear extensions that are perpendicular to a second set of parallel linear extensions. These linear extensions may also have different lengths and may extend inward to different locations within the wound dressing component. Preferably, the sensor array portion does not cover the entire wound dressing component, so that gaps are formed between the multiple portions of the sensor array. As shown in Figure 2, this allows the sensor array to remove some, and possibly most, of the coverage of the wound dressing component. For example, with respect to a perforated wound contact layer as shown in Figures 2 and 3D, the sensor array portion 301 does not need to block the majority of perforations in the wound contact layer. In some embodiments, the sensor array may also be perforated or shaped to match the perforations in the wound contact layer in order to minimize the obstruction of perforations to the fluid flow.

[0202] Figure 3D shows a flexible sensor array incorporated into a perforated wound contact layer 320 according to several embodiments. As shown, the sensor array may be sandwiched between two films or wound contact layers. The wound contact layer may have perforations formed as slits or holes as described above, small enough to allow wound exudate to flow into the dressing while helping to prevent tissue infiltration into the wound dressing. In some embodiments, the wound contact layer may have one or more slits that increase the flexibility of the wound contact layer with the integrated sensor array. In some embodiments, one of the wound contact layers may have an extra cutout to accommodate the sensor so that the sensor can come into direct contact with the skin.

[0203] The connectivity of a sensor array can vary depending on the various sensors and sensor array designs used. In some embodiments, as shown in Figure 3B, for example, a total of 79 connection points may be used to connect the components of the sensor array. The sensor array can be terminated at two contact surfaces of 40 parallel flat flexible cables (FFCs) with a pitch of 0.5 mm, with terminals on the top surface, and is designed to connect to FFC connectors such as Molex 54104-4031.

[0204] In some embodiments, one or more thermistors, conductivity sensors, SpO2 sensors, or color sensors can be used on a sensor array to provide information related to the state of the wound. The sensor array and individual sensors can assist clinicians in monitoring wound healing. One or more sensors may operate individually or in conjunction with each other to provide data related to the wound and wound healing characteristics.

[0205] Temperature sensors may use thermocouples or thermistors to measure temperature. Thermistors may be used to measure or track the temperature of the underlying wound or the thermal environment within the wound dressing. Thermometers can be calibrated, and data obtained from the sensor may be processed to provide information about the wound environment. In some embodiments, ambient sensors that measure ambient air temperature can also be used to help eliminate problems related to ambient temperature shifts.

[0206] Using an optical sensor, the appearance of a wound can be measured using an RGB sensor with an illumination source. In some embodiments, both the RGB sensor and the illumination source can be pressed against the skin, allowing light to penetrate the tissue and exhibit the spectral characteristics of the tissue itself.

[0207] Light propagation within tissues can be governed by two main phenomena: scattering and attenuation. Attenuation occurs when light passes through tissue, its intensity may be reduced due to absorption by various components of the tissue. Blue light tends to attenuate significantly, while light at the red end of the spectrum tends to attenuate the least.

[0208] Scattering processes can be more complex and may have various "regimes" that must be considered. The first mode of scattering is based on the size of the scattering center compared to the wavelength of the incident light. If the scattering center is considerably smaller than the wavelength of light, Rayleigh scattering can be assumed. If the scattering center is about the same size as the wavelength of light, a more detailed formulation of Mie scattering must be considered. Another factor involved in scattered light is the distance between the input and output of the scattering medium. If the mean free path of light (distance between scattering events) is considerably longer than the distance traveled, ballistic photon transport is assumed. In the case of tissue, since scat events are approximately 100 microns apart, a path distance of 1 mm would effectively randomize the direction of the photons, and the system would enter a diffusive regime.

[0209] Ultra-high brightness light-emitting diodes (LEDs), RGB sensors, and polyester light filters are used as components of the optical sensor to measure through tissue color differentiation. For example, since surface color can be measured from reflected light, color can be measured from the light that first passes through the tissue relative to a given shape. This may include sensing diffused light, i.e., color from an LED in contact with the skin. In some embodiments, the LED may be used in conjunction with a nearby RGB sensor to detect light diffused through the tissue. The optical sensor may image with diffused internal light or surface reflected light.

[0210] In addition, optical sensors can be used to measure autofluorescence. Autofluorescence is used because tissue absorbs light at one wavelength and emits it at another. Furthermore, since dead tissue cannot emit autofluorescence, this can be a very clear indicator of whether the tissue is healthy or not. Having UV light from a nearby red-sensitive photodiode (or some other wavelength-shifted band) to act as a binary test against healthy tissue that will, for example, emit autofluorescence at a very specific wavelength due to blue light (or even UV light) with such a shallow penetration depth can be very useful.

[0211] Conductivity sensors can be used to determine the difference between living and dead tissue, or to indicate changes in impedance due to an open wound in pathological tissue. Conductivity sensors may include Ag / AgCl electrodes and impedance analyzers. Conductivity sensors can be used to measure changes in impedance in an enlarged area of ​​a wound by measuring the impedance of the surrounding tissue / range. In some embodiments, a sensor array may utilize conductivity sensors to measure changes in conductivity on surrounding electrodes due to changes in wound size or wound shape. In some embodiments, conductivity sensors can be used in or around a wound bed.

[0212] In some embodiments, a pH-varying pad may be used as a pH sensor. A spectrometer and a broadband white light source may be used to measure the spectral response of the pH dye. Illumination and imaging may be provided on the surface of the wound dressing in contact with the wound and on the bottom surface which is in the same plane as the fluid application. Alternatively, in some embodiments, the illumination and imaging sources may be provided on the surface of the wound dressing opposite the bottom surface and away from the fluid application, or on the top surface of the dressing.

[0213] In some embodiments, pulsed oximetry SpO2 sensors can be used. It is possible to observe how blood is oxygenated and how pulsating blood flows. Pulse oximetry measurements work by performing time-resolved measurements of light absorption / transmission at two different light wavelengths. When hemoglobin is oxygenated, its absorption spectrum changes with respect to deoxygenated blood. By performing measurements at two different wavelengths, a measurement scale is obtained that uses the ratio of how the blood is oxygenated.

[0214] The components within the sensor array may be connected by multiple connections. In some embodiments, thermistors may be arranged in groups of five. Each thermistor is nominally 10kΩ, and each group of five has a common ground. There are five groups of thermistors, providing a total of 30 connections. In some embodiments, there may be nine conductive terminals. Each conductive terminal requires one connection, providing a total of nine connections. In some embodiments, there may be five SpO2 sensors. Each SpO2 sensor requires three connections in addition to power and ground (these are covered separately), providing a total of 15 connections. In some embodiments, there may be 10 color pH sensors. Each color sensor includes an RGB LED and an RGB photodiode. Each color sensor requires six connections, however, five of these are common to all sensors, providing a total of 15 connections. Power and installation are considered separately. In some embodiments, there may be five pH sensors. The pH sensors may be color-changing disks and can be sensed using the color sensors described above. Therefore, the pH sensor does not require any additional connections. There are three power rails and seven ground return signals, which can provide a total of 10 common connections. Some embodiments may include 25 thermistors (Murata NCP15WB473E03RC), 9 conductivity terminals, 5 SpO2 (ADPD144RI), 10 RGB LEDs (such as KPTF-1616RGBC-13), 10 RGB color sensors, 10 FETs, a printed circuit board (PCB), and an assembly.

[0215] The control module may be used in conjunction with the sensor array. In some embodiments, the control module may include a power source, such as a battery, and electronic equipment to drive the sensors. The control module may also enable data logging at appropriate intervals and data transfer to an external computer device, such as a personal computer (PC). The control module may be customized to have various features depending on the sensors used in the sensor array and the data collected by the sensors. In some embodiments, the control module may be small enough to be worn continuously for several weeks. In some embodiments, the control module may be located near or on the wound dressing. In some embodiments, the control module may be located remotely from the wound dressing and the associated sensor array. Whether located on, near, or remote from the wound dressing, the control module may communicate with the sensor array and the wound dressing via wires or wireless communication. In some embodiments, the control module may be adapted for use with different sensor arrays, allowing for easy replacement of the sensor arrays.

[0216] In some embodiments, the control module may include, but is not limited to, the features listed in Table 1 below, a variety of combinations of requirements and features. Table 1: Any Features Related to the Control Module

[0217] [Table 1]

[0218] Figure 3E shows a block diagram 330 of a control module according to several embodiments. The block diagram of the control module includes a conductivity driver box 391, which displays the characteristics of a conductivity driver. Box 392 displays the characteristics of a thermistor interface, and box 393 displays the characteristics of an optical interface. The control module may include a controller or microprocessor with features similar to those shown in box 394. A real-time clock (RTC), status LEDs, a USB connector, serial flash, and a debug connector may be included as feature components of the control module, as shown in Figure 3E.

[0219] In some embodiments, the microprocessor may have one or more of the following features: a 2.4GHz or other suitable frequency radio (either integrated or external), a Bluetooth software stack to supply, an SPI interface, USB (or UART for an external USB driver), I2C, 3-channel PWM, 32 GPIOs, or a 6-channel ADC. In some embodiments, the device may require at least 48 I / O pins, or possibly more, due to limitations that make it bulky. A minimum of 32kB may be required, as the Bluetooth stack typically requires less than 20kB of onboard flash. In some embodiments, 64kB may be required if complex data processing is to be considered. The processor core may be an ARM Cortex M4 or a similar processor core. In some embodiments, the components may include an ST STM32L433LC or STM32F302R8, or an NXP Kinetis KW class radio including an external or integrated radio.

[0220] In some embodiments, the control module may include memory components, and the amount of local storage depends on the sensor's sampling rate and resolution. For example, an estimated data requirement of 256Mb (32MB) can be met by using serial flash devices from several manufacturers (Micron, Spansion).

[0221] The control module may utilize one or more analog switches. In some embodiments, analog switches with good on-resistance and reasonable bandwidth may be used. For example, Analog Devices' ADG72 or NXP's NX3L4051HR may be used. Based on the initial system architecture, eight of these may be required.

[0222] The control module may incorporate a power source such as a battery. For example, a 300mWh / day battery may be used, totaling 2100mWh for 7 days. This can be provided by a 10-day supply of non-rechargeable ER14250 (14.5mm diameter x 25mm) LiSOCl2 cell, or a 7-day supply of rechargeable Li 14500 (14.5mm diameter x 500mm) Li-ion battery.

[0223] The control module may incorporate a real-time clock (RTC). The RTC can be selected from any RTC device with a crystal. The control module may also include various resistors, capacitors, connectors, a charge controller, and other power supply components.

[0224] The control module's PCB may be a four-layer board approximately 50mm x 20mm or 25mm x 40mm in size. The type of PCB used can be largely driven by the connection requirements for the sensor array.

[0225] The control module housing may be a two-part molded product with clip features that allow easy access for charging the sensor array or battery.

[0226] Data collected through the sensor array passes through a control module and can be processed by host software. The software may run on a processing device, which may be a PC, tablet, smartphone, or other computer capable of running the host software. The processing device running the software may communicate with the control module via wires or wireless communication. In some embodiments, the software may be configured to provide access to data stored on the control module rather than performing big data analysis. The host software may include an interface to the control module via Bluetooth or USB. In some embodiments, the host software may read the status of the control module, download log data from the control module, upload sample rate control to the control module, convert the control module data into a format suitable for processing by a big data analysis engine, or upload the data to a cloud for processing by the analysis engine.

[0227] The software may be developed for PCs (Windows / Linux®), tablets or smartphones (Android / iOS), or for multiple platforms.

[0228] In some embodiments, some or all of the other components of the local negative pressure system, such as a negative pressure source (e.g., a pump), as well as power supplies, sensors, connectors, user interface components (e.g., buttons, switches, speakers, screens, etc.) and the like, may be integrated with the wound dressing. In some embodiments, the components may be integrated below the top of the backing layer, inside the top, above the top, or adjacent to the backing layer. In some embodiments, the wound dressing may include a second positioning cover layer or a second filter layer on top of either the wound dressing layer or the integrated components. The second cover layer may be the top layer of the dressing or may be a separate outer shell that surrounded the integrated components of the local negative pressure system.

[0229] As used herein, the upper layer, top layer, or upper layer refers to the layer furthest from the surface of the skin or wound while the dressing is in use and positioned over the wound. Conversely, the lower layer, bottom layer, bottom layer, or lower layer refers to the layer closest to the surface of the skin or wound while the dressing is in use and positioned over the wound.

[0230] [Arrangement of components] In some embodiments, electrical or electronic components such as sensors, connectors, etc., may be placed, positioned, or embedded on one or more wound dressing components, the wound dressing components may be placed in or on the wound, skin, or both the wound and skin. For example, one or more electronic components may be positioned on the wound contact layer side facing the wound, such as the lower surface 224 of the wound contact layer 222 in Figure 1B. The wound contact layer may be flexible, elastic, or stretchable, or substantially flexible, elastic, or stretchable, in order to conform to or cover the wound. For example, the wound contact layer may be made from stretchable or substantially stretchable materials such as polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), and polyetherimide (PEI), along with various fluoropolymers (FEPs) and copolymers, or other suitable materials. In some examples, one or more electronic components may be positioned or embedded in, or further, one or more of the permeable layer, absorbent layer, backing layer, or any other suitable layer of the wound dressing.

[0231] In some implementations, it may be desirable for the wound contact layer to be elastic to better conform to or cover the wound, although at least some of the electronic components may not be elastic or flexible. In such cases, once the wound is covered with the wound dressing and the wound contact layer is positioned in or over the wound, undesirable or excessive localized strain or stress may be applied to one or more electronic components, such as on their support areas or mounting points. For example, such stress may result from patient movement, changes in the shape or size of the wound (due to its healing), etc. Such stress may cause one or more electronic components to move, detach, or malfunction (e.g., an open circuit caused by the disconnection of a pin or another connector). To ensure that measurements collected by one or more electronic components accurately capture changes over time in the same or substantially the same location or area of ​​the wound, 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 on the wound contact layer, in contact with the wound. The surface of a flexible wound contact layer may move, for example, as the patient moves, but it may be desirable to have one or more electronic components positioned in the same location or area relative to the wound.

[0232] As described herein, in some embodiments, one or more rigid, stiff, and non-stretchable, or substantially rigid, stiff, and non-stretchable regions, such as one or more regions of non-stretchable or substantially non-stretchable material, may be attached, positioned, or arranged on a wound contact layer (or another suitable wound dressing component) for supporting one or more electronic components. Attaching, positioning, or arranging one or more electronic components on one or more non-stretchable or substantially non-stretchable regions may prevent the formation of local stress or assistance associated with maintaining the position of one or more electronic components relative to the wound. In some examples, or, or further, one or more electronic components may be flexible, such as being attached to, printed on, or supported by one or more flexible materials. For example, flexible plastic sheets or substrates such as polyimide, polyetheretherketone (PEEK), polyester, silicone, etc., may be used.

[0233] Figures 4A to 4C show wound dressings 400 having multiple electronic components according to several embodiments. As shown, a sheet or substrate 430 is configured to support one or more electronic components, including an electronic component or module 402 having multiple connectors 404 and multiple electronic connections 410, and non-stretchable or substantially non-stretchable regions 422 and 424. The substrate 430 may be a stretchable or substantially stretchable wound contact layer as described herein. The electronic module 402 may be any electronic component described herein, such as a sensor, a light source (LED, temperature sensor, light sensor, etc.), a controller, or a processor (communication processor, etc.). The electronic connections 410 may be tracks printed on the substrate 430 using, for example, conductive copper, conductive ink (e.g., silver ink, graphite ink, etc.). At least some of the electronic connections 410 may be flexible or stretchable, or substantially flexible or stretchable. The connector 404 may be configured to electrically connect the electronic module 402 to the electronic connection 410 (as shown in Figure 4B), and may further connect to other electronic modules (not shown) positioned on the substrate 430, on or within other components of the wound dressing, or outside the wound dressing. The connector 404 may consist of pins, lead wires, bumps, pads, etc. Furthermore, or separately, a socket may be used to support and electrically connect the electronic module 402. Regions 422 and 424 may include non-stretchable or substantially non-stretchable materials, such as adhesives, epoxy, polyester, polyimide, polyamide, PET, PBT, or other types of materials having a high Young's modulus. One or more of regions 422 and 424 may be printed on the substrate 430. Printing the material on the substrate as used herein may include laminating, bonding, or one or more of other preferred techniques.

[0234] Figure 4B shows components arranged on the substrate 430. As shown, the electronic module 402 is mounted to or supported by region 422. Part or part of the electronic connection 410 is mounted to or supported by region 424. In some embodiments, slits, holes, or perforations formed in the substrate 430 are also illustrated. As described herein, the substrate 430 can be perforated using one or more of the following: cold pin perforation, hot pin perforation, laser excision perforation, ultrasonic or ultrasonic perforation, etc., to make the wound contact layer permeable to liquids and gases. In some implementations, one or more of the perforation processes used can produce a substrate that is flat or substantially flat around the holes, rather than an uneven surface (e.g., the surface of a donut mold). Having a flat or substantially flat substrate can help produce a homogeneous layer when conformal coating is performed (by spray, brush, etc., as described herein). Furthermore, when drilling around a component, using a drilling process that leaves the substrate surface uneven or substantially uneven can increase the risk of removing one or more components, such as the electronic connection 410 or the electronic module 402.

[0235] In certain embodiments, perforations are created or patterned around one or more components located on the substrate 430, such as an electronic connector 410, an electronic module 402, or a region 422 or 424. As described herein, component indices can be used to automatically position one or more components on the substrate 430 so that one or more components are not damaged by the perforations. In some embodiments, the substrate can be perforated in front of one or more components located on the substrate, as shown in Figure 4A.

[0236] Figure 4C illustrates one or more applications of the coating 440 or one or more adhesive regions 452, 454, 456 according to several embodiments. The coating 440 may be a similar coating configured to enclose or cover one or more components of the substrate 430 or components supported by the substrate, such as an electronic connector 410 or an electronic module 402. The coating 440 may provide biocompatibility or block or protect electronic devices from contact with fluids, etc. The coating 440 may be one or more of the following: a suitable polymer, an adhesive such as a 1072M UV, light, or thermosetting or cured adhesive, an Optimax adhesive (NovAchem Optimax 8002-LV, etc.), parylene (Parylene C, etc.), silicone, epoxy, urethane, acrylic urethane, or another suitable biocompatible and stretchable material. The coating 440 may be thin, such as about 100 microns thick, thinner than about 100 microns, or thicker than about 100 microns. The coating 440 can be applied and cured using one or more of UV, light, or heat curing. In some embodiments, the coating 440 can be applied to the other side of the substrate 430 (or the side opposite the wound), particularly if the substrate is not impermeable to fluids. In some embodiments, the coating is optional.

[0237] As illustrated, one or more adhesive pads, tracks, or regions 452, 454, 456 can be applied to the wound-facing side of the substrate 430. In some embodiments, the first adhesive region 452 can be shaped, sized, and positioned to contact or to adhere an electronic module 402 to a first specific or characteristic portion of the wound, such as a first specific or characteristic range, region, or location in contact with the wound. The adhesive region 452 can similarly be shaped and sized to adhere a region 422 or electronic module 402 to a specific location in the wound. Similarly, the second adhesive region 454 can be shaped, sized, or positioned to adhere a portion or part of an electronic connector 410, held by region 424, to a second specific or characteristic portion of the wound, such as a second specific or characteristic range, region, or location in contact with the wound. Another (third) area of ​​the adhesive 456 is shown, which allows another part of the wound contact layer to be bonded to another (third) specific or specific area, region, or arrangement of the wound, such as contacting the wound or another (third) specific or specific area, region, or arrangement thereto. The adhesive material may be one or more of silicone, e.g., two-component silicone, one-component silicone, gel, epoxy, acrylic material, or other suitable material. The adhesive may be applied and cured using one or more of UV, light, or heat curing. For example, the adhesive may be printed, sprayed, coated, etc., and cured by UV, light, heat curing, catalyst, water vapor, etc. In some embodiments, the adhesive is optional.

[0238] In some embodiments, one or more adhesive areas may be patterned to contact the wound or position or attach specific components to a specific range, region, or location relative to the wound, even when the substrate 430 is under stress or strain. The substrate may strain between the adhesive areas, but an electronic module 402, such as a sensor, will remain in contact with the wound or in the same position relative to the wound (due to the adhesive area 452), thereby maintaining the most repeatable signal, and a portion or part of the electronic connector 410 will remain in contact with the wound or in the same position relative to the wound, so that the electronic connector 410 is not dragged across the wound (due to the adhesive area 454) when the substrate 430 is subjected to strain. Furthermore, the support range or mounting area of ​​the electronic module 402 will not be subjected to great stress (for example, because one or more adhesive areas attach the wound contact layer to the wound), as the body (e.g., skin, which may strain about 20%) will relieve some of the stress, and the substrate will flex around the electronic module. Similar stress relief can be provided to the portion of the electronic connection 410 covered by the adhesive area 454. This can prevent malfunction of one or more electronic components.

[0239] In certain embodiments, the pattern of the adhesive area may be based on the positioning of one or more electronic components, which can be determined using the indexing described herein. As described herein, it may be desirable to pattern the adhesive to equalize stress or strain on the wound contact layer. The adhesive may be patterned to reinforce or support a specific range or area, such as the area where one or more electronic components are placed, while distributing stress or weakening (reducing the stiffness of) other areas to prevent one or more electrical components from becoming distorted. For example, it may be desirable to cover at least 50% or more of the wound-facing surface of the wound contact layer together with the adhesive. In certain implementations, the adhesive may be applied to cover or substantially cover the entire wound-facing side of the wound contact layer.

[0240] In some embodiments, the adhesive material used to form one or more adhesive regions may be non-stretchable or substantially non-stretchable. One or more regions of the non-stretchable or substantially non-stretchable material, for example regions 422 and 424, may not be used or may be sized or molded to be different from one or more adhesive regions.

[0241] Although a single electronic module 402 is illustrated in Figures 4A to 4C, multiple electronic modules may be used in certain implementations. One or more additional electronic modules, or one or more electronic connectors 410 interconnecting electronic module 402 with additional electronic modules, may be placed on one or more additional non-stretchable or substantially non-stretchable areas. Furthermore, or alternatively, the adhesive area may be positioned to contact or adhere to the wound, as described herein, for the further attachment of one or more electronic modules or electronic connectors.

[0242] [Part sealing and stress relief] As described herein, biocompatible coatings may be applied to wound contact layers or electronic components placed on wound contact layers. In some embodiments, the wound contact layer comprises a thin, flexible substrate that conforms to the wound. For example, the substrate may be made from a stretchable or substantially stretchable material or film, such as polyurethane, TPU, silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, PET, PBT, PEN, or PEI, along with various FEPs and copolymers or other suitable materials. The substrate may not be biocompatible. The coating may be flexible. The coating may include one or more suitable polymers, adhesives, e.g., 1072-M adhesive (e.g., Dymax 1072-M), 1165-M adhesive (e.g., NovAchem Optimax 8002-LV, Dymax 1165-M, etc.), 10901-M adhesive (e.g., Dymax 1901-M, or 9001-E Dymax), parylene (e.g., Parylene C), silicone, epoxy, urethane, acrylic urethane, acrylic urethane substitute (e.g., Henkel Loctite 3381), or other suitable biocompatible and substantially stretchable materials. The coating can be thin, for example, from about 80 microns or less to several millimeters or more. As described herein, the coating can be applied by curing by one or more of the following: lamination, bonding, welding (e.g., ultrasonic welding), light, UV, heat, etc. The coating can be transparent or substantially transparent to allow optical detection. The coating can maintain its bonding strength after sterilization, such as EtO sterilization. The coating can have a hardness of approximately A100, A80, A50 or less. The coating can have an elongation at break of approximately 100%, 200%, 300% or more. The coating can have a viscosity of approximately 8,000 to 14,500 centipoise (cP). In some cases, the coating can have a viscosity of approximately 3,000 cP or more. In some cases, the coating can have a viscosity of less than approximately 3,000 cP. The coating can be fluorescent.

[0243] The substrate and the electronic components supported by the substrate may be desirable to be conformal in order that the substrate and electronic components are intended to be placed on or within a body. One characteristic of conformal is the extensibility of the coating material, as it may be necessary to isolate the electronic components from wounds. (If the substrate is stretchable or substantially stretchable,) the coating applied to the substrate may need to be able to stretch together with the substrate. By combining the extensibility of both the substrate and the coating, the desired properties of the device can be maximized. In some embodiments, it may be formed from a TPU film. The coating can be formed from acrylic urethane, e.g., 1165-M Dymax, 1072-M Dymax, or other suitable materials described herein.

[0244] The substrate may need to be coated uniformly and comprehensively (for example, the substrate may be sealed with a biocompatible coating). The material is They may be hydrophilic, and therefore may need to be sealed with a hydrophobic coating in order to create a hydrophobic dressing that is placed on or inside a wound.

[0245] Figures 5A-5B illustrate coatings of wound dressings according to several embodiments. As described herein, one surface of the substrate 530 of the wound dressing may include a plurality of electronic components 402 protruding from the surface. This is illustrated, for example, in Figures 4A-4C, where an electronic module 402 protrudes from the wound-facing surface of the substrate 430. As shown in Figure 5A, a coating 440A can be applied to the surface of the substrate supporting the electronic components. As described herein, the coating 440A may be biocompatible. The coating 440A may be hydrophobic. The coating 440A may be substantially stretchable or extensible.

[0246] As shown in Figure 5B, coating 440B can be applied to the opposite side of the substrate. This may be advantageous when the substrate is neither biocompatible nor hydrophobic. Coating 440B can be biocompatible. Coating 440B can be hydrophobic. Coating 440B can be substantially stretchable or extensible. Coatings 440A and 440B may be the same or different. The substrate 530 can be sealed within the coating as shown in Figure 5B. Although not shown, the left and right sides of the substrate 530 are also sealed with the coating.

[0247] Figure 6 illustrates the coating of wound dressings using two biocompatible coatings according to several embodiments. An electronic component 402 supported by a substrate 530 can be coated with coating 640A, particularly when the substrate 530 is stretchable or substantially stretchable. As described herein, coating 640A can be non-stretchable or substantially non-stretchable in order to provide stress relief to the electronic component (which may include an electronic module or electronic connection). Coating 640A can be applied on and around the electronic component. Coating 640A can be biocompatible. Coating 640A can be hydrophobic.

[0248] Non-stretchable or substantially non-stretchable coatings described herein, such as coating 640A, can be formed from acrylate or modified urethane materials (e.g., Henkel Loctite 3211). For example, the coating may be one or more of Dymax 1901-M, Dymax 9001-E, Dymax 20351, Dymax 20558, Henkel Loctite 3211, or other suitable materials. The coating may have a viscosity of about 13,500 cP to 50,000 cP before drying, or about 3,600 cP to about 6,600 cP before drying. In some cases, the coating may have a viscosity of about 50,000 cP or less. The coating may have a hardness of about D40 to about D65 and / or a linear shrinkage of about 1.5 to 2.5%. The coating may be transparent or substantially transparent to allow optical detection. The coating may be colorless or substantially colorless. Coating 640A may be fluorescent. The coating may retain its bonding strength after sterilization, such as EtO sterilization.

[0249] As shown in the illustration, coating 640B can be applied to the remaining surface of the substrate supporting the electronic component. Coating 640B may also be applied to the opposite side of the substrate. Although not shown, the left and right sides of the substrate 530 are also sealed with the coating. Coating 640B may be biocompatible. Coating 640B may be hydrophobic. Coating 640B may be substantially elastic or extensible. Coating 640B may be similar to one or more flexible or substantially flexible coatings described herein. For example, coating 640B may be formed from acrylate urethane or a substitute thereof, e.g., 1165-M Dymax, 1072-M Dymax, Henkel Loctite 3381, or another suitable material.

[0250] In some embodiments, non-stretchable or substantially non-stretchable coatings may not be biocompatible. As shown in Figure 7, an electronic component 402 supported by a substrate 530 is coated with a non-stretchable or substantially non-stretchable coating 740A, which is not biocompatible. A second coating 740B can be applied to the surface of the substrate 530 supporting the electronic component. Coating 740B can be applied on top of coating 740A. Coating 740B may also be applied to the opposite side of the substrate. Although not shown, the left and right surfaces of the substrate 530 are also sealed with coating 740B. Coating 740B can be biocompatible. Coating 740B can be hydrophobic. Coating 740B can be substantially stretchable or extensible.

[0251] Coating thin, flexible substrates with biocompatible materials is not straightforward because the substrate needs to be coated on the opposite side where electronic components are located. Furthermore, the substrate may need to be coated uniformly and comprehensively (for example, the substrate may be sealed with a biocompatible coating).

[0252] In some embodiments, an apparatus 500 for coating a wound contact layer can be used, as shown in Figure 8. The apparatus 500 includes a bottom frame 514 and a top frame 512 attached to the frame 514. The substrate 530 is held in place by tension or substantially tension between the frames 514 and 512. In some embodiments, the substrate 530 can be mounted on a backing made of a material with a high Young's modulus (e.g., PET, PBT, or another suitable material), such as a substantially rigid backing. The backing can be molded as a frame and mounted around the substrate 530. The substrate 530 is tightened or held within the apparatus 500 so that the substrate does not sag. In some embodiments, the frame 514 can be mounted on the base described herein.

[0253] In some embodiments, the coating can be applied thinly and uniformly. For example, the coating can be sprayed. In some embodiments, a biocompatible coating can be applied to the wound contact layer by the apparatus 600 shown in Figure 9. As shown, the substrate 530 is held by the apparatus 500. The coating is applied by the apparatus 610, which can spray the coating material onto both sides of the substrate 530. For example, after coating the first side of the substrate 530, the apparatus 500 can be flipped over to coat the opposite side of the substrate 530. Frames 514 and 512 can be made from materials to which the coating will not adhere. Such materials may include PTFE, nylon, or one or more of other suitable materials. For example, a PTFE frame is illustrated in the figure.

[0254] As described herein, one of the surfaces of the wound contact layer may include multiple electronic components protruding from the surface. This is illustrated, for example, in Figures 4A-4C, where an electronic module 402 protrudes from the wound-facing surface of the substrate 430. To efficiently and accurately coat the opposite side of such a substrate, a plate or mold 700 as shown in Figure 10 can be used in some embodiments. As shown, the mold 700 has recesses 710 in which one or more electronic components can be positioned. Such recesses may also be called indentations, notches, imprints, wells, or contours. In some embodiments, the recesses 710 are molded to allow the electronic components to be comfortably positioned. The opening area or depth of the recesses 710 may be greater than the combined area or depth of the electronic components, and the coating provides comfortable support. By positioning one or more electronic components in one or more recesses, the opposite side of the substrate can be kept flat, substantially flat, or smooth, and the coating can be applied evenly to that side. Furthermore, the mold 700 can prevent the substrate from becoming clogged.

[0255] In certain implementations, the mold 700 can be made from a material to which the coating does not adhere. Such materials may include PTFE, nylon, or one or more of other suitable materials. For example, a PTFE mold is illustrated in the figure.

[0256] In some embodiments, the mold may include recesses 710 that are molded or positioned to allow coating of various substrates which may have different arrangements of electronic components. The mold 700 may include, for example, surplus or additional recesses 710 that are not used when a first substrate is being coated. At least some of such additional recesses 710 may be used when a second substrate is being coated, as they are positioned or molded to allow positioning of electronic components on the second substrate.

[0257] Figures 11 and 12A-12B illustrate an apparatus 800 for coating wound dressings according to several embodiments. In the apparatus 800, the mold 700 is placed on a base 518 that provides support. The base 518 can be made from a material to which the coating will not adhere. Such materials may include nylon, PTFE, or one or more of other suitable materials. For example, a nylon base is illustrated in the figure.

[0258] The frame 514 is also positioned on the base as shown in the example. In some embodiments, the frame 514 includes one or more pins configured to be attached to one or more holes on the base. The pins may be dowel pins.

[0259] Frame 512 can also be attached to frame 514 as shown in the example. In a particular implementation, the attachment is carried out using one or more pins located on one of the frames and alignment holes located on the other frame. The pins may be dowel pins.

[0260] In the illustrated arrangement, the substrate (not shown) can be positioned on the side supporting the electronic components placed on the mold 700 and can be held in place by the tension between frames 514 and 512. This makes it possible to apply the coating to the opposite side of the surface supporting the electronic components. The mold 700 can then be removed, and the substrate can be flipped over and placed between frames 514 and 512 as described herein, and the surface holding the electronic components can be coated.

[0261] In some embodiments, the surface of the substrate supporting the electronic component is coated first. The substrate can be held between frames 514 and 512 using apparatus 500 (without mold) or 800 (with mold). The mold 700 may have a thickness that takes into account the thickness of the coating. The mold 700 has the thickness of frame 514 minus the coating thickness. For example, if a 150 micron (0.15 mm) coating is applied to the surface of the substrate supporting the electronic component, the frame 514 may be 10 mm thick and the mold 700 may be 9.85 mm thick. When the substrate is turned over and the coated surface supporting the electronic component is placed in the mold 700, the substrate is precisely horizontal on the mold 700 and held by the tension between frames 514 and 512, allowing the coating of the opposite (non-component) surface of the substrate.

[0262] In some implementations, as illustrated in FIG. 13, a rigid or substantially rigid release layer or release liner 1010 can be used additionally or alternatively. The release liner 1010 can be applied to the substrate 530 to coat the substrate with the substrate in a tensioned or substantially tensioned state. The release liner 1010 can be applied to the first surface of the substrate 530 (e.g., the surface that does not support the electronic component) and can coat the opposite surface. Thereafter, the release liner 1010 can be removed and the other surface (e.g., the side that supports the electronic device) can be coated. When the release liner 1010 is applied to the coated surface, the other surface can be coated. The release liner can be formed as a window frame as illustrated in FIG. 13. The release liner can be adhered to the substrate or attached by any other suitable method.

[0263] In certain implementations, the release liner 1010 can function as the backing described herein.

[0264] In some embodiments, as illustrated in FIGS. 14A-14B, the mold of the wound contact layer can be cast so as to hold the wound contact layer flat or substantially flat during coating. As shown in FIG. 14A, a casting material 1110 can be injected to cast a mold or die 1120. The mold includes shaped and arranged recesses 1122 sized to fit a plurality of electronic components supported by the wound contact layer. Such recesses may also be referred to as depressions, notches, imprints, wells, or contours.

[0265] FIG. 14B illustrates coating the substrate 530 using the mold 1120. The substrate 530 includes a plurality of electronic components 1102 protruding from the surface of the substrate. The electronic components 1102 are disposed in the recesses 11, 22 of the mold 1120 so that the opposite side of the substrate is substantially flat. The coating 1140 is applied uniformly to seal the opposite side and its surface of the substrate.

[0266] The surface of the substrate 530 supporting the component can be coated before or after coating the opposite side. For example, a release liner, e.g., liner 1010, or another backing can be applied to the opposite, uncoated side to coat the surface of the substrate 530 supporting the electronic component. The substrate 530 can then be flipped over and placed in the mold 1120 to coat the opposite side, as illustrated in Figure 14B. As described herein, the recess 1122 of the mold 1120 can be molded and sized to accommodate the coating on the electronic component.

[0267] As described herein, in some embodiments, acrylic urethanes can be used as coating materials because these polymers have suitable adhesive properties and extensibility. Spray coating of acrylic urethanes using compressed air or an inert gas may result in oxygen inhibition of the polymerization reaction for curing the acrylic urethane. Removing oxygen from the system eliminates the adverse effect on the polymerization reaction for curing the acrylic urethane.

[0268] Figure 15 illustrates spray coating of wound dressings according to several embodiments. The spray device 1200 includes a dispenser 1230 connected to a pressurized cylinder 1220 that stores air or an inert gas. The coating 1240 is sprayed from the dispenser 1230 onto a substrate 530 by the force of compressed air or gas. The substrate can be held under tension or substantially under tension by a device 1210 which may include at least one of a plurality of frames or molds as described herein. The coating 1240 may be biocompatible. The coating 1240 may be hydrophobic. The coating 1240 may be substantially stretchable or extensible.

[0269] In some embodiments, a non-stretchable or substantially non-stretchable coating can be applied to at least some of a plurality of electronic components. Figure 16 illustrates the application of a non-stretchable material to a wound dressing according to some embodiments. The spraying device 1000 includes a dispenser 1030 connected to a pressurized cylinder 1020 that stores air or an inert gas. The force of compressed air or gas sprays the coating 1110 from the dispenser 1030 onto the connecting track 410. The coating 1110 can be stretchable or substantially non-stretchable. Instead of coating the track 410, or in addition to coating it, electronic modules can also be coated.

[0270] In some embodiments, a single layer of stretchable or non-stretchable coating can be applied. In some embodiments, multiple layers of stretchable or non-stretchable coating can be applied. For example, a desired stiffness or rigidity can be achieved by applying multiple layers of non-stretchable coating.

[0271] Figures 17A and 17B illustrate performance comparisons with and without non-stretchable materials in several embodiments. Figure 17A illustrates how much an electrical connection uncoated with a non-stretchable or substantially non-stretchable coating stretches. Stretching may occur, for example, due to patient movement.

[0272] Figure 17B illustrates how much an electronic connection coated with a non-stretchable or substantially non-stretchable coating stretches. As illustrated, both the uncoated electronic connection 410A and the coated electronic connection 410C are approximately the same length when not stretched. However, the uncoated electronic connection 410B stretches to a much longer length than the coated electronic connection 410D.

[0273] In some embodiments, the wound dressings described herein may need to comply with one or more safety standards, such as the IEC 60601 standard for the safety and effectiveness of medical electrical equipment. Such one or more standards may require very stringent test methods to ensure the electrical safety of the wound dressing. The coatings described herein, such as coatings 440, 440A, 440B, 640A, 640B, 740A, 740B, and 1240, can be applied to a substrate to ensure compliance with applicable safety standards. For example, the coatings can protect the electrical components of the wound dressing from liquid ingress and ensure electrical safety. The coatings described herein can be formed from materials that comply with one or more applicable safety standards.

[0274] In some embodiments, the coating may include one or more existing materials, such as films. Such existing materials may be manufactured or tested to comply with one or more applicable safety standards, such as IEC 60601, and then one or more materials may be applied to the substrates described herein. In certain embodiments, the existing materials may be TPU, acrylic urethane, or other materials.

[0275] In some implementations, coatings can be applied over electronic components, which may result in localized thinning or stretching of the coating layer. This may be due to the uneven surface of the substrate as a result of the placement of the electronic components. In some cases, if the coating is not sprayed, localized thinning or stretching may be present or detectable.

[0276] In certain embodiments, electromagnetic / radio frequency shielding can be applied to the coated surface to protect electronic components from electromagnetic interference. For example, conductive ink can be used. The ink may be silicone, silver, or the like.

[0277] [Sealing and stress relief of components using perforated substrates] In some embodiments, the substrate 430 may include one or more perforations. These one or more perforations can improve one or more of the accuracy, efficiency, or speed of the coating process, as described below. One or more perforations can be fabricated in the substrate 430 to improve the coating process.

[0278] Figure 18 illustrates wound dressings 1800 having one or more perforations according to several embodiments. The illustrated dressings 1800 include a substrate 430 supporting one or more electronic modules 402 that are electrically connected to one or more electronic connectors 410 by one or more connectors 404. The electrical connection between the modules 402 and the one or more electronic connectors 410 can be formed by soldering one or more connectors 404 of the modules 402 to the one or more electronic connectors 412, or by using other preferred means, such as sockets, surface mounts, etc. The substrate 430 includes one or more perforations 470. As illustrated, the perforations 470 may be located beneath the modules 402. In some embodiments, additional perforations may be made beneath the modules 402. In some cases, one or more perforations may be made neither beneath nor away from the modules 402.

[0279] One or more perforations 470 can release any bubbles or air bubbles that may form when coating the substrate 430 and one or more components supported by the substrate. As described herein, the removal of oxygen or air can eliminate adverse effects on the polymerization reaction for curing the acrylic urethane. Figure 19A illustrates a coating 1300A of the wound dressing 1800 according to one or more embodiments. As described herein (see, for example, Figures 6-7), one or more modules 402 (and one or more electronic connections 410) can be coated with a non-stretchable or substantially non-stretchable coating to provide stress relief. Figure 19A illustrates such a coating 480 that has been applied. The coating 480 can flow under the module 402 as illustrated. This allows gas or air to escape through one or more perforations 470 rather than being trapped within the coating or under the module 402. In some cases, the coating 480 may have a viscosity sufficient to facilitate efficient flow, but it may not be so viscous that it does not provide the necessary stress relaxation to module 402, as a highly viscous material may not conform perfectly around module 402. As described herein, the coating 480 may have a viscosity of about 13,500 to 50,000 cP, or about 3,600 to 6,600 cP (e.g., about 17,000 cP). In some cases, the coating may have a viscosity of about 50,000 cP or less. As illustrated, one or more perforations 470 may be completely or partially filled with the coating 480. In some implementations, the coating process can be facilitated by creating a pressure difference across the substrate 430. For example, applying a higher pressure to the top surface of the substrate 430 (the part side in the illustration) than to the bottom on the opposite side of the substrate 430 can force the coating 480 to flow into the perforations 470. In some implementations, the upper surface of the substrate 430 can be spray-coated using higher pressure, for example, by spray-coating with compressed air or an inert gas.

[0280] Figure 19 illustrates coatings 1300b of wound dressing 1800 according to several embodiments. Wound dressing 1200 may already be coated with coating 480, as described in relation to Figure 19A. Additional coatings may be applied to wound dressing 1200 as described herein. For example, as described in relation to Figures 5A-5B, such additional coatings may be one or more of biocompatible, hydrophobic, or substantially elastic or extensible. The substrate 430 may be sealed or substantially sealed using the additional coatings.

[0281] As illustrated in Figure 19B, one or more of the additional coatings 492 and 494 can be applied to the wound dressing 1200. Coating 492 can be applied to the top surface (or component side) of the substrate 430. Coating 494 can be applied to the bottom surface on the opposite side of the substrate 430.

[0282] In some embodiments, one or more release liners may be used during the process of manufacturing or coating the wound dressing 1200. For example, a release liner (not shown) may be provided on the bottom surface of the substrate 430, which can be peeled off after the successful application of coating 492 but before the application of coating 494. An additional liner may be applied to the top surface of the substrate 430 before the application of the soft coat 494, which may then be removed. By using one or more such release liners, it can be ensured that coating 492 is not applied to areas where coating 494 should be applied, and vice versa.

[0283] Any one or more of coatings 480, 492, or 494 can be applied using any one or more of the methods described herein. In some cases, any of the one or more perforations 470 can be completely or partially filled with one or more of the coatings described herein, such as one or more of coatings 480 or 494. In some implementations, any of the one or more perforations can be partially filled with one or more coatings to allow fluids, such as wound exudate, to pass through the wound dressing.

[0284] [Other variations] In some embodiments, one or more electronic components can be disposed on the side of the wound contact layer opposite the side facing the wound. The systems and methods described herein are similarly applicable to such wound contact layers. Although spraying of coatings has been described above, other suitable methods for applying coatings can be used in certain embodiments. Such methods include dip coating, spin coating, vapor deposition, chemical deposition, electrochemical deposition, roll-to-roll coating, lamination, adhesion, welding (e.g., ultrasonic welding), curing by one or more of light, UV, heat, etc.

[0285] The specific embodiments described herein relate to wound dressings, but the systems and methods disclosed herein are not limited to wound dressings or medical applications. The systems and methods disclosed herein are generally applicable to general electronic devices, such as electronic devices that a user can wear or apply to the user.

[0286] The values ​​such as thresholds, limits, and periods given herein are not intended to be absolute values ​​and may therefore be approximate. Furthermore, any thresholds, limits, periods, etc. provided herein may be fixed or changed automatically or by the user. In addition, as used herein, terms expressing relative degrees such as exceeding, greater than, and less than a reference value are intended to include cases where the value is equal to the reference value. For example, exceeding a positive reference value may include being greater than or equal to the reference value. Moreover, as used herein, terms expressing relative degrees such as exceeding, greater than, and less than a reference value are intended to include the opposite of disclosed relationships such as being below, less than, and greater than a reference value. Furthermore, blocks of various processes may be described in relation to determining whether a value reaches or does not reach a particular threshold, but blocks may also be interpreted, for example, in relation to whether a value is (i) less than or greater than a threshold, or (ii) meets or does not meet a threshold.

[0287] It should be understood that any properties, substances, features, or groups described in relation to a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described herein, provided that they are not incompatible. All of the features disclosed herein (including any of the appended claims, abstract, and drawings), or any of the steps of any method or process disclosed herein, may be combined in any combination, except for any combination in which at least some of such features or steps are mutually exclusive. The protections of the present invention are not limited to the details of any of the embodiments described herein. The protections extend to any novel features or any novel combination of features disclosed herein (including any of the appended claims, abstract, and drawings), or to any novel steps or any novel combination of any method or process disclosed herein.

[0288] While specific embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications may be made in the forms of the methods and systems described herein. Those skilled in the art will recognize that, depending on the embodiment, the actual steps performed in the illustrated or disclosed process may differ from the steps shown in the figures. Depending on the embodiment, certain steps among the steps described above may be omitted, and others may be added. For example, the actual steps or the order of steps performed in the disclosed process may differ from those shown in the figures. Depending on the embodiment, certain steps among the steps described above may be omitted, and others may be added. For example, the various components shown in the figures 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 can be combined in various ways to form further embodiments, all of which will remain within the scope of this disclosure.

[0289] This disclosure includes specific embodiments, examples, and uses, but it will be understood by those skilled in the art that the disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses, as well as obvious modifications thereof and their equivalents, including embodiments that do not necessarily provide all of the features and advantages described herein. Therefore, the scope of this 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 thereafter.

[0290] Conditional phrases such as “can,” “could,” “might,” or “may” are typically intended to convey that a particular embodiment includes a particular feature, element, or step, while other embodiments do not, unless otherwise specifically stated or interpreted within the context in which they are used. Therefore, such conditional phrases are not necessarily intended to suggest that the feature, element, or step is required to some extent in one or more embodiments, or that logic for determining whether or not such feature, element, or step is included in any particular embodiment, or should be implemented in such embodiment, is necessarily included in one or more embodiments, with or without user input or instruction. Terms such as “comprising,” “including,” and “having” are synonyms and are used in an inclusive, non-restrictive manner, not excluding additional elements, features, actions, and behaviors. Furthermore, the term "or" is used in an inclusive (rather than exclusive) sense, meaning, for example, when used to connect a list of elements, it refers to one, some, or all of the listed elements. In addition, the term "each," as used herein, has its usual meaning, but can also refer to any subset of the set of elements to which the term "each" applies.

[0291] Conjunctions such as "at least one of X, Y, and Z" are to be interpreted separately, in the context generally used to indicate that an item or term can be either X, Y, or Z, unless otherwise specifically stated. Therefore, such conjunctions are not typically intended to suggest that a particular embodiment must include at least one of X, at least one of Y, and at least one of Z.

[0292] As used herein, expressions of degree, such as the terms “approximately,” “about,” “generally,” and “substantially,” describe a value, quantity, or characteristic that is close to a given value, quantity, or characteristic that still performs the desired function or produces the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may mean quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given quantity. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” mean a value, quantity, or characteristic that is 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degrees or less from a state of being exactly parallel.

[0293] The scope of this disclosure is not intended to be limited by any specific disclosure of preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims presented in this section or elsewhere in this specification, or presented thereafter. The language of these claims should be interpreted broadly based on the language used in these claims, and not limited to the examples described herein or during the proceedings of this application, and such examples should be interpreted non-exclusively. [Additional note 1] A method for coating a wound dressing, wherein the method is The first surface of the flexible wound contact layer of the wound dressing is coated with a hydrophobic coating, wherein the first surface of the wound contact layer supports a plurality of electronic components. A method comprising coating the second surface of the wound contact layer opposite to the first surface with a hydrophobic coating, wherein the wound contact layer is formed at least partially from a hydrophilic material. [Additional note 2] The method according to Appendix 1, further comprising sealing the wound contact layer with the coating. [Additional note 3] The method according to any one of the appendices 1 to 2, wherein the coating is hydrophobic. [Additional note 4] The coating is biocompatible, as described in any one of the appendices 1 to 3. [Additional note 5] The method according to any one of appendices 1 to 4, wherein the coating is substantially stretchable. [Additional note 6] The method according to any one of the appendices 1 to 5, wherein the plurality of electronic components each have at least one electronic connection. [Additional note 7] The method according to any one of the appendices 1 to 6, further comprising coating at least some of the aforementioned electrical components with a plurality of coating layers. [Additional note 8] The method according to any one of the appendices 1 to 7, wherein coating the first and second surfaces of the wound contact layer includes spraying the coating. [Additional note 9] The method described in Appendix 8, which includes spraying using compressed air or an inert gas. [Additional Note 10] The coating is formed from a material conforming to the IEC 60601 standard, as described in any one of the appendices 1 to 9. [Additional Note 11] A method for coating a wound dressing, wherein the method is The plurality of electronic components supported by the first surface of the flexible wound contact layer of the wound dressing are coated with a first biocompatible coating, A method comprising coating one or more remaining areas of the first surface of the wound contact layer and the second surface of the wound contact layer opposite the first surface with a second biocompatible coating. [Additional Note 12] The method according to Appendix 11, wherein the first coating is substantially non-stretchable. [Additional Note 13] The method according to Appendix 11, wherein the first coating comprises at least one of Dymax 20351, Dymax 20558, Dymax 9001-E, or Loctite 3211. [Additional Note 14] The wound contact layer is formed from at least a partially hydrophilic material, according to any one of appendices 11 to 13. [Additional Note 15] The method according to any one of appendices 11 to 14, wherein the first and second coatings are hydrophobic. [Additional Note 16] The first and second coatings are formed from materials conforming to IEC 60601, according to the method described in any one of appendices 11 to 15. [Additional Note 17] The first coating, as described above, has a viscosity of approximately 50,000 centipoise or less, as described in any one of appendices 11 to 16. [Additional Note 18] A method for coating a wound dressing, wherein the method is The plurality of electronic components supported by the first surface of the flexible wound contact layer of the wound dressing are coated with a non-biocompatible coating, A method comprising coating the first surface of the wound contact layer, which comprises the plurality of electrical components, and the second surface of the wound contact layer opposite the first surface with a biocompatible coating. [Additional Note 19] The method according to Appendix 18, wherein the non-biocompatible coating is substantially non-stretchable. [Additional Note 20] The method according to any one of appendices 18 to 19, wherein coating the first wound contact layer with the biocompatible coating includes coating the non-biocompatible coating that covers the plurality of electronic components. [Additional Note 21] The biocompatible coating is hydrophobic, as described in any one of appendices 18 to 20. [Additional Note 22] The biocompatible coating is formed from a material conforming to IEC 60601, according to the method described in any one of appendices 18 to 21. [Additional Note 23] A method for coating a wound dressing, wherein the method is The flexible wound contact layer of the wound dressing is positioned substantially under tension between a first and a second frame, wherein the wound contact layer comprises a first surface supporting a plurality of electronic components protruding from the surface of the first surface and a second surface opposite the first surface, the second surface being substantially smooth. A method comprising coating the wound contact layer with a biocompatible coating. [Additional note 24] The first surface of the wound contact layer is supported by a mold in a substantially flat position, wherein the mold comprises a plurality of recesses configured to support the plurality of electronic components. The method according to Appendix 23, further comprising applying the coating substantially uniformly to the second surface of the wound contact layer. [Additional note 25] The second surface of the wound contact layer is held in a substantially flat position between the first and second frames, The method according to Appendix 24, further comprising applying the coating substantially uniformly to the first surface of the wound contact layer. [Additional note 26] The coating is the method according to any one of appendices 23 to 25, comprising spraying the biocompatible coating. [Additional note 27] The method described in Appendix 26, which includes spraying using compressed air or an inert gas. [Additional note 28] The coating includes sealing the wound contact layer with the biocompatible coating. The method according to any one of appendices 23 to 27. [Additional note 29] The biocompatible coating is formed from a material conforming to IEC 60601, according to the method described in any one of appendices 23 to 28. [Additional note 30] The method according to any one of appendices 1 to 29, further comprising forming at least one perforation in the substantially flexible wound contact layer before coating the first surface of the substantially flexible wound contact layer supporting the plurality of electronic components. [Additional note 31] The method according to appendix 30, further comprising forming at least one perforation beneath at least one electronic component. [Additional note 32] The method according to either appendix 30 or 31, further comprising applying higher pressure to the first surface than to the second surface of the substantially flexible wound contact layer when coating the first surface. [Additional note 33] A wound dressing prepared by a process, wherein the process is The arrangement involves placing a plurality of electronic components on the first surface of the wound contact layer of the wound dressing, wherein the wound contact layer is at least partially formed from a hydrophilic material. The first surface of the wound contact layer comprising the plurality of electronic components is coated with a hydrophobic coating, A wound dressing comprising coating the second surface of the wound contact layer opposite to the first surface with the hydrophobic coating. [Additional note 34] The wound dressing according to Appendix 33, wherein the wound contact layer is flexible. [Additional note 35] The aforementioned coating is biocompatible, as described in any one of the appendices 33 to 34. [Additional note 36] The wound dressing according to any one of appendices 33 to 35, wherein the coating is substantially stretchable. [Additional note 37] The coating is a wound dressing as described in any one of appendices 33 to 36, formed from a material conforming to the IEC 60601 standard. [Additional note 38] The wound dressing according to any one of appendices 33 to 37, further comprising coating the plurality of electronic components with another substantially non-stretchable coating before coating the first surface of the wound contact layer with the hydrophobic coating. [Additional note 39] The wound dressing according to any one of appendices 33 to 38, further comprising forming at least one perforation in the wound contact layer before coating the first surface of the wound contact layer supporting the plurality of electronic components. [Additional note 40] The wound dressing according to appendix 39, wherein at least one perforation is formed beneath at least one electronic component. [Additional note 41] The wound dressing according to either appendix 39 or 40, wherein the process further comprises applying a higher pressure to the first surface than to the second surface of the wound contact layer when coating the first surface. [Additional note 42] A wound dressing manufactured and / or coated by the method described in any one of the appendices 1 to 41. [Additional note 43] An apparatus for coating wound dressings, wherein the apparatus is The first frame and A second frame, configured to be attached to the first frame and further configured to fix a flexible wound contact layer of the wound dressing between the first and second frames, wherein the wound contact layer comprises a first surface supporting a plurality of electronic components protruding from the surface of the first surface, and a second surface opposite to the first surface, the second surface being substantially smooth, The apparatus wherein the first and second frames are configured to substantially support the wound contact layer under tension so that a biocompatible coating can be applied to the first and second surfaces of the wound contact layer. [Additional note 44] The apparatus according to Appendix 43, further comprising a base and a mold having a plurality of recesses configured to support the plurality of electronic components, wherein the mold and the first frame are configured to be positioned on the base, and the mold is further configured to support the first surface of the wound contact layer in a substantially flat position so that the coating can be applied substantially uniformly to the second surface of the wound contact layer. [Additional note 45] The apparatus according to Appendix 44, wherein the mold is configured to support a plurality of wound contact layers in the substantially flat position, and at least one of the plurality of wound contact layers has a different arrangement of electronic components than the second wound contact layer of the plurality of wound contact layers. [Additional note 46] The apparatus according to any one of appendices 43 to 45, wherein the wound contact layer comprises thermoplastic polyurethane. [Additional note 47] The apparatus according to any one of the appendices 43 to 46, wherein the coating includes urethane acrylate. [Additional note 48] The apparatus according to any one of appendices 43 to 47, wherein the coating is applied to seal the wound contact layer. [Additional note 49] The apparatus according to any one of the appendices 43 to 48, wherein at least one of the plate or the mold comprises nylon or polytetrafluoroethylene (PTFE). [Additional Note 50] The apparatus described in any one of the appendices 43 to 49, wherein the coating is applied as a spray. [Additional note 51] The apparatus according to Appendix 50, further comprising a spraying device configured to discharge an uncured coating onto the wound contact layer, thereby removing oxygen and curing the coating, with a storage section filled with compressed air or an inert gas. [Additional note 52] The apparatus according to any one of the appendices 43 to 51, wherein the wound contact layer is configured for use in providing negative pressure wound therapy. [Additional note 53] An apparatus for coating wound dressings, wherein the apparatus is A body comprising a plurality of recesses configured to support the plurality of electronic components supported on a first surface of the wound contact layer of the wound dressing, wherein the plurality of electronic components protrude from the surface of the first surface, and the wound contact layer further comprises a substantially smooth second surface opposite to the first surface, The apparatus is configured such that the main body supports the first surface of the wound contact layer in a substantially flat position so that a biocompatible coating can be applied to the second surface of the wound contact layer. [Additional note 54] The apparatus according to Appendix 53, wherein the plurality of recesses are formed and positioned and molded to substantially match the shape and arrangement of the plurality of electronic components. [Additional note 55] A method for coating an electronic device, wherein the method is The first surface of a flexible substrate of the electronic device is coated with a hydrophobic coating, wherein the first surface of the substrate supports a plurality of electronic components. A method comprising coating a second surface of the substrate opposite to the first surface with the hydrophobic coating, wherein the substrate is formed at least partially from a hydrophilic material. [Additional note 56] A method for coating an electronic device, wherein the method is The plurality of electronic components supported by the first surface of the flexible substrate of the electronic device are coated with a first biocompatible coating, A method comprising coating one or more remaining areas of the first surface of the substrate and the second surface of the substrate opposite the first surface with a second biocompatible coating. [Additional note 57] A method for coating an electronic device, wherein the method is The plurality of electronic components supported by the first surface of the flexible substrate of the aforementioned electronic device are coated with a non-biocompatible coating. A method comprising coating the first surface of the substrate having the plurality of electronic components and the second surface of the substrate opposite to the first surface with a biocompatible coating. [Additional note 58] A method for coating an electronic device, wherein the method is The arrangement involves substantially tensilely positioning a flexible substrate of the electronic device between a first and a second frame, wherein the substrate comprises a first surface supporting a plurality of electronic components protruding from the surface of the first surface and a second surface opposite the first surface, the second surface being substantially smooth. A method comprising coating the aforementioned substrate with a biocompatible coating. [Additional note 59] Wound dressings manufactured and / or coated as shown and / or described. [Additional note 60] A method for manufacturing and / or coating wound dressings as shown and / or described. [Additional note 61] Apparatus for coating wound dressings as shown and / or described.

Claims

1. A method for coating wound dressings, A coating step comprising coating the first surface of the flexible wound contact layer of the wound dressing with a hydrophobic coating, wherein the first surface of the wound contact layer supports a plurality of electronic components, A method comprising the step of coating the second surface of the wound contact layer opposite to the first surface with a hydrophobic coating, wherein the wound contact layer is formed at least partially from a hydrophilic material, The method further comprises the step of forming at least one perforation in the substantially flexible wound contact layer, thereby coating the inner wall of the perforation, before coating the first surface of the substantially flexible wound contact layer supporting a plurality of electronic components.

2. The method according to claim 1, further comprising the step of sealing the wound contact layer with the coating.

3. The method according to claim 1 or 2, wherein the coating is hydrophobic.

4. The method according to any one of claims 1 to 3, wherein the coating is substantially stretchable.

5. The method according to any one of claims 1 to 4, wherein the plurality of electronic components each have at least one electronic connection portion.

6. The method according to any one of claims 1 to 5, further comprising the step of coating at least some of the plurality of electronic components with a plurality of coating layers.

7. The method according to any one of claims 1 to 6, wherein the step of coating the first and second surfaces of the wound contact layer includes the step of spraying the coating.

8. The method according to any one of claims 1 to 7, wherein the coating is formed from a material conforming to the IEC 60601 standard.

9. The method according to claim 1, further comprising the step of forming at least one perforation beneath at least one electronic component.

10. The method according to claim 1 or 8, further comprising the step of applying higher pressure to the first surface than to the second surface of the substantially flexible wound contact layer when coating the first surface.

11. A wound dressing manufactured and / or coated by the method according to any one of claims 1 to 10.

12. A wound dressing prepared by a process, wherein the process is A step of arranging a plurality of electronic components on a first surface of the wound contact layer of the wound dressing, wherein the wound contact layer is at least partially formed from a hydrophilic material, The steps include coating the first surface of the wound contact layer, which comprises a plurality of the aforementioned electronic components, with a hydrophobic coating, A wound dressing comprising the step of coating the second surface of the wound contact layer opposite to the first surface with the hydrophobic coating, A wound dressing, wherein the process further includes the step of forming at least one perforation in the wound contact layer, thereby coating the first surface of the wound contact layer supporting a plurality of electronic components, so that the inner wall of the perforation is coated.

13. The wound dressing material according to claim 12, wherein the wound contact layer is flexible.

14. The wound dressing according to claim 12 or 13, wherein the coating is substantially stretchable.

15. The wound dressing according to any one of claims 12 to 14, wherein the coating is formed from a material conforming to the IEC 60601 standard.

16. The wound dressing according to any one of claims 12 to 15, further comprising the step of coating a plurality of the electronic components with another substantially non-stretchable coating before coating the first surface of the wound contact layer with the hydrophobic coating.

17. At least one of the perforations is formed beneath at least one electronic component, and / or The wound dressing according to claim 12, wherein the process further includes the step of applying a higher pressure to the first surface than to the second surface of the wound contact layer when coating the first surface.

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