Implementing integrated wound monitoring and / or therapy dressings and systems with sensors

Abstract

This invention provides an integrated wound monitoring and / or treatment dressing and system implementing sensors. The wound monitoring and / or treatment system may include: a substantially stretchable substrate supporting a plurality of electronic components including sensors and a plurality of electronic connections connecting at least some of the electronic components. The electronic components may also include a circuit board supporting at least one controller configured to control at least some of the sensors, the circuit board being configured to operate faultlessly when the substrate flexes due to strain. A calibration track may be positioned on the substrate and connected to monitoring circuitry configured to measure resistance changes in the calibration track, the resistance changes indicating resistance changes in at least some of the plurality of electronic connections. The system may include a controller, wherein the circuit board supports a plurality of electrical components and an antenna configured to communicate with the substrate, the antenna at least partially surrounding the circuit board.

Description

[0001] This invention is a divisional application, with its parent application number being 201880073094.1, filed on November 14, 2018, and entitled "Integrated Wound Monitoring and / or Treatment Dressing and System Implementing Sensors".

[0002] Incorporation by citing any priority claim This application claims priority to U.S. Provisional Application No. 62 / 586848, filed November 15, 2017, entitled “INTEGRATED SENSOR ENABLED WOUND THERAPY DRESSINGS AND SYSTEMS”. This application also claims priority to UK Patent Application No. 1718866.5, filed November 15, 2017, entitled “INTEGRATED SENSOR ENABLED WOUND THERAPY DRESSINGS AND SYSTEM”. This application further claims priority to UK Patent Application No. 1718855.8, filed November 15, 2017, entitled “SENSOR ENABLED WOUND THERAPY DRESSINGS SYSTEMS AND MONITORING ELECTRICAL IMPEDANCE CHANGES”. This application also claims priority to UK Patent Application No. 1718868.1, filed November 15, 2017, entitled “ANTENNAS FOR SENSOR ENABLED WOUND THERAPYDRESSINGS AND SYSTEMS”. The disclosures of these earlier applications are incorporated herein by reference in their entirety and should be considered part of this specification. Technical Field

[0003] Embodiments of this disclosure relate to devices, systems, and methods for monitoring and / or processing tissues by means of sensor-enabled monitoring, either alone or in combination with various treatment regimens. Background Technology

[0004] Almost all medical fields can benefit from improved information about the condition of tissues, organs, or systems being treated, especially if such information is collected in real time during treatment. Many types of treatment are still routinely performed without the use of sensor data acquisition; instead, these treatments rely on caregiver visual inspection or other limited methods rather than quantitative sensor data. For example, in wound management using dressings and / or negative pressure wound therapy, data acquisition is often limited to visual inspection by a caregiver, and the underlying injured tissue may often be obscured by bandages or other visual barriers. Even intact, uninjured skin may have underlying damage invisible to the naked eye, such as damaged blood vessels that could lead to ulceration or deeper tissue damage. Similar to wound management, during orthopedic treatment, the limb is immobilized using a mannequin or other packaging, and only limited information is collected on the underlying tissues. In cases of internal tissue repair (e.g., bone plates), continuous, direct sensor-driven data acquisition is not performed. Furthermore, braces and / or sleeves used to support musculoskeletal function do not monitor the function of the underlying muscles or the movement of the limb. Beyond direct treatment, common hospital ward items, such as beds and blankets, can be improved by increasing the ability to monitor patient parameters.

[0005] Therefore, there is a need to improve sensor monitoring, particularly by using substrates that can be incorporated into existing monitoring and / or processing solutions. Summary of the Invention

[0006] In some cases, wound monitoring and / or treatment systems include a wound dressing configured to be positioned above a wound. The wound dressing includes a substantially stretchable substrate supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the electronic components. The plurality of electronic components may include a plurality of sensors configured to acquire measurement data of at least one of the wound or its surrounding area. The plurality of electronic components may include at least one controller positioned on a circuit board configured to control at least some of the sensors. The circuit board is formed of a reinforcing material and configured to operate faultlessly when the circuit board flexes due to strain on the wound dressing.

[0007] The system described in any of the preceding paragraphs or any system described herein may include one or more of the following features: The material of the circuit board may have been reinforced by undergoing compression to increase the material's resilience to flexural stress. The material of the circuit board may have been reinforced by pre-strain. The wound dressing may include a coating covering at least some of the plurality of electronic components and at least some of the plurality of electronic connections, and the material of the circuit board may have been reinforced by the coating compressing the material of the circuit board when applied to the wound dressing. The coating may be hydrophobic and / or biocompatible. The wound dressing may also include an antenna configured to transmit measurement data to a remote computing device.

[0008] The system described in any of the preceding paragraphs or any system described herein may include one or more of the following features: The system may include a power source positioned on the substrate, the power source being configured to power the plurality of electronic components. The power source may not be enclosed in a separate housing or enclosure. The substrate may include a first portion and a second portion, and the power source may include an anode supported by the first portion of the substrate and a cathode supported by the second portion of the substrate, and the power source may further include an electrolyte layer positioned between the anode and the cathode. The anode may be positioned on a first electronic connection of the plurality of electronic connections, and the cathode may be positioned on a second electronic connection of the plurality of electronic connections.

[0009] The system described in any of the preceding paragraphs or any system described herein may include one or more of the following features. The at least one controller is configured to be activated by one or more of the following: bending the wound dressing, activating an activation switch, bursting bubbles in conductive material, charging a transistor, activating a magnetic trigger, or triggering a piezoelectric element. The system may not be configured to be physically connected to an external controller that controls any of the plurality of sensors or receives any of the measurement data. The substrate may include a plurality of perforations configured to allow fluid to pass through the substrate. The system may include a negative pressure source configured to be fluidly connected to the wound dressing and to supply negative pressure to the wound.

[0010] In some cases, wound monitoring and / or treatment systems include a wound dressing configured to be positioned over a wound. The wound dressing includes a substantially stretchable substrate supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the electronic components. The plurality of electronic components include a plurality of sensors configured to acquire measurement data of at least one of the wound or surrounding tissues. The system may include a control module configured to be connected to the wound dressing. The control module includes: at least one controller configured to acquire the measurement data from the plurality of sensors; and a power supply configured to provide power to the at least one controller and the plurality of sensors, the at least one controller and the power supply being encapsulated in a housing.

[0011] The system described in any of the preceding paragraphs or any system described herein may include one or more of the following features. The enclosure may include a first portion supporting the at least one controller and power supply, and a second portion configured to be attached to at least one pin positioned on the first portion. The enclosure may be configured to substantially shield the at least one controller from at least one of electromagnetic interference (EMI) or electrostatic discharge (ESD).

[0012] In some cases, a method of manufacturing a wound dressing configured to be positioned over a wound and used in a wound monitoring and / or treatment system includes: pre-straining a circuit board including a controller by at least one of: stretching at least a portion of a substantially flexible substrate of the wound dressing; positioning the circuit board on at least a portion of the substrate; and subsequently relaxing or compressing at least said portion of the substrate; and subsequently positioning the circuit board on the substrate. The substrate may support a plurality of sensors and a plurality of electronic connections configured to acquire measurement data of at least one of the wound or its surrounding area, the plurality of electronic connections connecting at least some of the sensors to the controller, and wherein the controller is configured to control at least some of the sensors. Pre-straining the circuit board increases the flexibility of the circuit board flexurally and allows the circuit board to operate fault-free when it flexes due to strain applied to the substrate.

[0013] The methods described in any of the preceding paragraphs or any methods described herein may include one or more of the following features. Pre-stressing the circuit board may include: positioning the circuit board on the substrate; covering at least a portion of the substrate, including the circuit board with a coating; and shrinking the coating by curing it, thereby applying compression to at least a portion of the substrate, including the circuit board. The coating may be at least one of biocompatible or hydrophobic.

[0014] In some cases, wound monitoring and / or treatment devices include: a wound dressing configured to contact and position with a wound, the wound dressing including a substantially stretchable substrate supporting a plurality of sensors and a plurality of conductive tracks, the plurality of sensors being configured to acquire measurements of at least one of the wound or the area surrounding the wound, the plurality of conductive tracks being electrically connected to the plurality of sensors and at least one calibration track positioned on the substrate, the at least one calibration track being electrically connected to monitoring circuitry, the monitoring circuitry being configured to measure a first resistance change of the at least one calibration track, the first resistance change of the at least one calibration track corresponding to a resistance change of at least some of the plurality of conductive tracks.

[0015] The device described in any of the preceding paragraphs or any system and / or device described herein may include one or more of the following features: The at least one calibration track may surround at least a portion of the periphery of the substrate. The at least one calibration track may include a plurality of calibration tracks, and each of the calibration tracks may be associated with a specific sensor among the plurality of sensors. The monitoring circuitry may be configured to measure the baseline resistance of the at least one calibration track when the substrate is not stretched, and to determine a first resistance change of the at least one calibration track based on the difference between the baseline resistance and the resistance of the at least one calibration track due to stretching and / or tearing of the substrate. The monitoring circuitry may also be configured to adjust the measurement obtained by one of the plurality of sensors based on the first resistance change.

[0016] The device described in any of the preceding paragraphs or any system and / or device described herein may include one or more of the following features: The device may include a controller configured to control at least some of the plurality of sensors to defer one or more measurement results in response to determining that a first resistance change exceeds a threshold. The controller may also be configured to control at least some of the plurality of sensors to obtain one or more measurement results in response to determining that a second resistance change is below the threshold, the second resistance change being measured after the first resistance change is measured. At least some of the plurality of sensors may include one or more sensors configured to measure impedance. The at least one calibration track may include a plurality of calibration tracks configured to measure a plurality of first resistance changes associated with a plurality of different regions of the substrate. The at least one calibration track may be configured to be connected to a power supply different from the plurality of sensors.

[0017] In some cases, a method of operating a wound monitoring and / or treatment device, the wound monitoring and / or treatment device including a wound dressing, the wound dressing including a substantially stretchable substrate supporting a plurality of sensors and a plurality of conductive tracks, the plurality of sensors being configured to obtain measurements of at least one of a wound or the area surrounding a wound, the plurality of conductive tracks being electrically connected to the plurality of sensors, the method may include: using a monitoring circuit of the wound monitoring device to measure a first resistance change of at least one calibration track positioned on the substrate, the first resistance change of the at least one calibration track corresponding to a resistance change of at least some of the plurality of conductive tracks.

[0018] The methods described in any of the preceding paragraphs or any methods described herein may include one or more of the following features: The at least one calibration track may surround at least a portion of the periphery of the substrate. The at least one calibration track may include a plurality of calibration tracks, and wherein each of the calibration tracks is associated with a specific sensor among the plurality of sensors, or wherein the plurality of calibration tracks are associated with measuring resistance changes in a plurality of different regions of the substrate. The method may include measuring the baseline resistance of the at least one calibration track when the intact substrate is not stretched, and determining a first resistance change of the at least one calibration track based on the difference between the baseline resistance and the resistance of the at least one calibration track due to stretching and / or tearing of the substrate.

[0019] The methods described in any of the preceding paragraphs or any methods described herein may include one or more of the following features. The method may also include adjusting a measurement obtained by one of the plurality of sensors based on the first resistance change. The method may further include: by a controller of the wound monitoring device: receiving the first resistance change from the monitoring circuit; determining that the first resistance change exceeds a threshold; and controlling at least some of the plurality of sensors to delay obtaining one or more measurement results. The method may further include: by the controller, determining that a second resistance change measured after measuring the first resistance change is below the threshold; and controlling at least some of the plurality of sensors to obtain one or more measurement results. At least some of the plurality of sensors may include one or more sensors configured to measure impedance.

[0020] In some cases, wound monitoring and / or treatment devices include: a wound dressing configured to contact and position with a wound, the wound dressing including a substantially stretchable substrate supporting a plurality of sensors configured to acquire measurements of the wound; and a controller configured to be electrically connected to the wound dressing and further configured to receive measurements acquired by the plurality of sensors of the wound dressing, the controller including a circuit board supporting a plurality of electrical components and an antenna configured to communicate with at least one of the wound dressing or a telecomputing device, wherein the antenna at least partially surrounds the circuit board supporting the plurality of electrical components.

[0021] The device described in any of the preceding paragraphs or any system and / or device described herein may include one or more of the following features. The antenna may surround the entire area of ​​the circuit board supporting the plurality of electrical components, except for a portion of the area including a plurality of connections configured to be electrically connected to the wound dressing. The antenna may surround the entire area of ​​the circuit board supporting the plurality of electrical components.

[0022] In some cases, wound monitoring and / or treatment devices include: a wound dressing configured to contact and position with a wound, the wound dressing including a substantially stretchable substrate supporting a plurality of sensors configured to acquire measurements of the wound; and a controller configured to be electrically connected to the wound dressing and further configured to receive measurements acquired by the plurality of sensors of the wound dressing, the controller including a circuit board supporting a plurality of electrical components and an antenna configured to communicate with at least one of the wound dressing or a telecomputing device, wherein the antenna is located in a first region of the circuit board, the first region being different from a second region in which the plurality of electrical components are located.

[0023] The device described in any of the preceding paragraphs or any system and / or device described herein may include one or more of the following features: The antenna may substantially surround the entire first region. The antenna may be C-shaped. The antenna may be L-shaped. The antenna may be rectangular, square, or circular. The antenna may be positioned away from the plurality of electrical components. The substrate may also support a plurality of conductive tracks electrically connecting the plurality of sensors, and at least some of said conductive tracks are configured to be electrically connected to the controller. The antenna may include a plurality of loops. The antenna may include three loops.

[0024] The device described in any of the preceding paragraphs or any system and / or device described herein may include one or more of the following features: The circuit board may include multiple layers, and multiple layers of the multilayer circuit board may support the antenna. The circuit board may include one or more vias configured to interconnect the antenna on each of the multiple layers. The antenna may be configured as a near-field antenna. The antenna may be positioned within an area defined by a 50 × 27 mm outer rectangle and a 35 × 13 mm inner rectangle of the controller, and the inner rectangle may be centered within the outer rectangle. The antenna may include a 3 mm angular radius. The antenna may be located within an area defined by an outer circle of 41 mm diameter and an inner circle of 24 mm diameter of the controller, and the inner circle may be concentric with the outer circle. The antenna may include copper wire, etched, or printed antenna material. Attached Figure Description

[0025] Embodiments of this disclosure will now be described below by way of example only with reference to the accompanying drawings, in which: Figure 1A The illustration shows a wound monitoring and treatment system according to some embodiments; Figure 1B The illustration shows the use of a wound monitoring and treatment system according to some embodiments; Figure 1C The illustration shows a wound dressing implementing a sensor according to some embodiments; Figure 2A The illustration shows a negative pressure wound therapy system according to some embodiments; Figure 2B The illustration shows wound dressings according to some embodiments; Figure 3 The illustration shows a sensor array according to some embodiments, illustrating sensor placement incorporated into a wound dressing; Figure 4A The illustration shows a flexible sensor array including a sensor array portion, a tail portion, and a connector pad end, according to some embodiments; Figure 4B The illustration shows flexible circuit boards with different sensor array geometries according to some embodiments; Figure 4C The diagram shows... Figure 4B Sensor array portion 301B of the sensor array shown; Figure 4D The illustration shows a flexible sensor array incorporated into a perforated wound contact layer according to some embodiments; Figure 4E The diagram illustrates a control module according to some embodiments; Figure 5A-5J The illustration shows a wound dressing implementing a sensor according to some embodiments; Figure 6 The illustration shows an integrated wound dressing with implemented sensors according to some embodiments; Figures 7A-7D and Figure 8 The illustration shows power integration in a wound dressing that implements a sensor according to some embodiments; Figure 9 The illustration shows an integrated wound dressing incorporating sensors according to some embodiments; and Figure 10 The illustration shows a wound dressing with a sealed sensor according to some embodiments.

[0026] Figure 11A-11C The illustration shows an impedance measurement according to some embodiments; Figure 12 The illustration shows a wound dressing configured to monitor changes in electrical impedance according to some embodiments; Figure 13 The illustration shows an arrangement for monitoring changes in electrical impedance according to some embodiments; and Figures 14A-14E The illustration shows the arrangement of a trajectory for monitoring changes in electrical impedance according to some embodiments.

[0027] Figures 15A-15B Figures 16A-16B and 17A-17B illustrate wound dressings with antennas for implementing sensors according to some embodiments. Detailed Implementation

[0028] The embodiments disclosed herein relate to apparatus and methods for monitoring and treating biological tissues using a substrate in which sensors are implemented. The embodiments disclosed herein are not limited to treating or monitoring specific types of tissue or wounds; in fact, the sensor-implementing techniques disclosed herein are broadly applicable to any type of treatment that can benefit from a substrate in which sensors are implemented. Some implementations utilize sensors and data acquisition relied upon by healthcare providers to make diagnoses and patient management decisions.

[0029] Some embodiments disclosed herein relate to the use of sensors mounted on or embedded in a substrate configured to handle both intact and damaged human or animal tissue. Such sensors can acquire information about the surrounding tissue and transmit this information to a computing device or caregiver for further processing. In some embodiments, these sensors can be attached to the skin anywhere on the body, including areas for monitoring arthritis, temperature, or other areas that may be prone to problems and require monitoring. The sensors disclosed herein may also incorporate markings, such as radiopaque markings, to indicate the presence of the device, for example, prior to performing an MRI or other technique.

[0030] The sensor embodiments disclosed herein can be used in conjunction with clothing. Non-limiting examples of clothing used with the sensor embodiments disclosed herein include shirts, trousers, pants, skirts, underwear, outerwear, gloves, shoes, hats, and other suitable garments. In some embodiments, the sensor embodiments disclosed herein may be soldered to or laminated into and / or onto a particular garment. Sensor embodiments may be printed directly onto clothing and / or embedded in the fabric. Breathable and printable materials, such as microporous membranes, may also be suitable.

[0031] The sensor embodiments disclosed herein can be incorporated into cushioning pads or mattresses, such as within hospital beds, to monitor patient characteristics, such as any of the characteristics disclosed herein. In some embodiments, a disposable membrane containing such sensors can be placed on the hospital bed as needed and removed / replaced.

[0032] In some implementations, the sensor embodiments disclosed herein may incorporate energy harvesting, making the sensor embodiments self-sustaining. For example, energy may be harvested from thermal energy sources, kinetic energy sources, chemical gradients, or any suitable energy source.

[0033] The sensor embodiments disclosed herein can be used in rehabilitation devices and treatments, including sports medicine. For example, the sensor embodiments disclosed herein can be used in brackets, sleeves, packaging materials, supports, and other suitable articles. Similarly, the sensor embodiments disclosed herein can be incorporated into sports equipment, such as helmets, sleeves, and / or padding. For example, such sensor embodiments can be incorporated into protective helmets to monitor characteristics such as acceleration, which can be used for concussion diagnostics.

[0034] The sensor embodiments disclosed herein can be used with surgical devices, such as the Smith & Nephew NAVIO surgical system. In some embodiments, the sensor embodiments disclosed herein can communicate with such surgical devices to guide their placement. In some embodiments, the sensor embodiments disclosed herein can monitor blood flow to or from a potential surgical site or ensure that there is no blood flow at the surgical site. Additional surgical data can be acquired to help prevent scar formation and monitor areas away from the affected area.

[0035] To further assist surgical techniques, the sensors disclosed herein can be incorporated into surgical drapes to provide information about the tissue beneath the drapes, information that may not be immediately visible to the naked eye. For example, a flexible drape with embedded sensors may have sensors that are advantageously positioned to provide improved area-centric data acquisition. In some embodiments, the sensor embodiments disclosed herein can be incorporated into the boundary or interior of the drapes to create a fencing to confine / control the operating room.

[0036] The sensor embodiments disclosed herein can also be used for preoperative assessment. For example, such sensor embodiments can be used to gather information about potential surgical sites, for instance, by monitoring the skin and underlying tissues to locate possible incision sites. For example, perfusion levels or other suitable characteristics can be monitored at the skin surface and deeper within the tissue to assess whether an individual patient is likely at risk for surgical complications. Sensor embodiments, such as those disclosed herein, can be used to assess the presence of microbial infection and provide indications for the use of antimicrobial agents. Furthermore, the sensor embodiments disclosed herein can gather further information in deeper tissues, such as identifying pressure ulcer lesions and / or adipose tissue levels.

[0037] The sensor embodiments disclosed herein can be used for cardiovascular monitoring. For example, such sensor embodiments can be incorporated into flexible cardiovascular monitors that can be placed close to the skin to monitor characteristics of the cardiovascular system and transmit this information to another device and / or caregiver. For example, such devices can monitor pulse rate, blood oxygen saturation, and / or the electrical activity of the heart. Similarly, the sensor embodiments disclosed herein can be used for neurophysiological applications, such as monitoring the electrical activity of neurons.

[0038] The sensor embodiments disclosed herein can be incorporated into implantable devices, such as implantable orthopedic implants, including flexible implants. Such sensor embodiments can be configured to acquire information about the implantation site and transmit that information to an external source. In some embodiments, an internal source can also provide power to the implant.

[0039] The sensor embodiments disclosed herein can also be used to monitor biochemical activities on or beneath the skin surface, such as lactose accumulation in muscles or sweat production on the skin surface. In some embodiments, other characteristics can 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 cracking.

[0040] The sensor embodiments disclosed herein can be incorporated into ear, nose, and throat (ENT) applications. For example, such sensor embodiments can be used to monitor the recovery from ENT-related surgeries, such as wound monitoring within sinus tracts.

[0041] As described in more detail below, the sensor embodiments disclosed herein may cover sensor printing techniques with encapsulation, such as encapsulation with polymer films. Such films can be constructed using any polymer described herein, such as polyurethane. The encapsulation of the sensor embodiments can provide water resistance to the electronics and protection against local tissues, local fluids, and other potential sources of damage.

[0042] In some embodiments, the sensors disclosed herein may be incorporated into an organ protection layer, as disclosed below. This sensor-embedded organ protection layer can protect the organ of interest and confirm that the organ protection layer is in proper position and provide protection. Furthermore, the sensor-embedded organ protection layer can be used to monitor underlying organs, for example, by monitoring blood flow, oxygenation, and other suitable markers of organ health. In some embodiments, the sensor-embedded organ protection layer can be used to monitor transplanted organs, for example, by monitoring the fat and muscle content of the organ. Additionally, the sensor-embedded organ protection layer can be used to monitor organs during and after transplantation, such as during organ recovery.

[0043] The sensor embodiments disclosed herein can be incorporated into wound care (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 treatment of intact skin; cardiovascular applications, such as monitoring blood flow; orthopedic applications, such as monitoring limb movement and bone repair; neurophysiological applications, such as monitoring electrical impulses; and any other tissue, organ, system, or situation where improved implementation of sensor monitoring may benefit.

[0044] Wound treatment Some embodiments disclosed herein relate to wound treatment for human or animal bodies. Therefore, any reference to wound herein may refer to a wound on a human or animal body, and any reference to the body herein may refer to a human or animal body. Embodiments of the disclosed techniques may relate to preventing or minimizing damage to physiological or living tissue, or to treating damaged tissue (e.g., wounds described herein) with or without decompression, including, for example, negative pressure sources and wound dressing components and devices. Devices and components comprising wound covering and filling materials or inner layers (if present) are sometimes collectively referred to herein as dressings. In some embodiments, wound dressings may be provided for use without reducing pressure.

[0045] Some embodiments disclosed herein relate to wound treatment for human or animal bodies. Therefore, any reference to wound herein may refer to a wound on a human or animal body, and any reference to the body herein may refer to a human or animal body. Embodiments of the disclosed technology may relate to preventing or minimizing damage to physiological or living tissues, or to the treatment of damaged tissue (e.g., the wounds described herein).

[0046] As used herein, the term "wound" can include damage to living tissue that may result from cutting, blows, or other impacts, typically involving a cut or rupture of the skin. Wounds can be chronic or acute. Acute wounds occur due to surgery or trauma. They undergo various healing stages within the expected timeframe. Chronic wounds often begin as acute wounds. When an acute wound does not follow the healing stages, it may become a chronic wound, thus prolonging recovery time. The transition from an acute wound to a chronic wound is thought to be likely due to compromised immune function in the patient.

[0047] Chronic wounds can include, for example: venous ulcers (such as those that appear in the legs), which account for the majority of chronic wounds and primarily affect older adults; diabetic ulcers (such as foot or ankle ulcers); peripheral artery disease; pressure sores or epidermolysis bullosa (EB).

[0048] Other examples of wounds include, but are not limited to: abdominal wounds or other large or open wounds caused by surgery, trauma, bone incision, fasciotomy or other conditions, lacerations, acute wounds, chronic wounds, subacute and laceration wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, stomas, surgical wounds, traumatic and venous ulcers, etc.

[0049] Wounds can also include deep tissue injuries. Deep tissue injury is a term coined by the National Pressure Ulcer Advisory Group (NPUAP) to describe a distinct form of pressure ulcer. For years, clinicians have used terms such as purple pressure ulcers, ulcers that may worsen and bruise on bony prominences to describe these ulcers.

[0050] Wounds may also include tissue that is at risk of becoming a wound as discussed herein. For example, at-risk tissue may include tissue on bony prominences (which carries the risk of deep tissue injury / damage) or preoperative tissue that may be cut (e.g., for joint replacement / surgical alteration / reconstruction) (e.g., knee tissue).

[0051] Some embodiments relate to methods of treating wounds using the techniques disclosed herein in combination with one or more of the following: advanced footwear, patient rotation, debridement (e.g., debridement of diabetic foot ulcers), infection management, systemic fusion, antimicrobial treatment, antibiotics, surgery, tissue removal, influencing blood flow, physiological therapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, active agent ozone, antibiotics, antimicrobial treatment, etc.

[0052] Alternatively or additionally, wounds can be treated with localized negative pressure and / or conventional advanced wound care, which is not aided by the application of negative pressure (also known as non-negative pressure therapy).

[0053] Advanced wound care may include the use of absorbent dressings, occlusive dressings, and the use of antimicrobial and / or debridement agents in wound dressings or applicators and pads (e.g., cushioning or compression therapy, such as stockings or bandages).

[0054] In some embodiments, these wounds may be treated with conventional wound care, wherein dressings may be applied to the wound to facilitate and promote wound healing.

[0055] Some embodiments relate to methods of manufacturing wound dressings, including providing wound dressings as disclosed herein.

[0056] Wound dressings that can be used in conjunction with the disclosed technology include any dressings known in the art. This technology is applicable to both negative pressure therapy and non-negative pressure therapy.

[0057] In some embodiments, the wound dressing includes one or more absorbent layers. The absorbent layer may be a foam or a superabsorbent.

[0058] In some embodiments, the wound dressing may include a dressing layer comprising a polysaccharide or modified polysaccharide, polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl ether, polyurethane, polyacrylate, polyacrylamide, collagen, or an adhesive or mixture thereof. Dressing layers comprising the listed polymers are known in the art as suitable for forming wound dressings for negative pressure or non-negative pressure therapy.

[0059] In some embodiments, the polymer matrix may be a polysaccharide or a modified polysaccharide.

[0060] In some embodiments, the polymer matrix may be cellulose. Cellulose materials may comprise hydrophilically modified cellulose, such as methylcellulose, carboxymethyl cellulose (CMC), carboxymethyl cellulose (CEC), ethylcellulose, propylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxyethyl cellulose sulfate, alkyl sulfonate cellulose, or mixtures thereof.

[0061] In some embodiments, the cellulose material may be a cellulose alkyl sulfonate. The alkyl moiety of the alkyl sulfonate substituent may be an alkyl group having 1 to 6 carbon atoms, such as methyl, ethyl, propyl, or butyl. The alkyl moiety may be branched or unbranched; therefore, a suitable propyl sulfonate substituent may be a 1- or 2-methyl-ethyl sulfonate. The butyl sulfonate substituent may be a 2-ethyl-ethyl sulfonate, a 2,2-dimethyl-ethyl sulfonate, or a 1,2-dimethyl-ethyl sulfonate. The alkyl sulfonate substituent may be an ethyl sulfonate. Cellulose alkyl sulfonates are described in WO10061225, US2016 / 114074, US2006 / 0142560, or US5,703,225, the disclosures of which are incorporated herein by reference in their entirety.

[0062] Cellulose alkyl sulfonates can have varying degrees of substitution, chain lengths in the cellulose backbone, and structures of the alkyl sulfonate substituents. Solubility and absorbability depend primarily on the degree of substitution: as the degree of substitution increases, cellulose alkyl sulfonates become increasingly soluble. Consequently, absorption increases with increasing solubility.

[0063] In some embodiments, the wound dressing may also include a top layer or a covering layer.

[0064] The thickness of the wound dressings disclosed in this article can be between 1 mm and 20 mm, or between 2 mm and 10 mm, or between 3 mm and 7 mm.

[0065] In some embodiments, the disclosed techniques may be used in conjunction with non-negative pressure dressings. Non-negative pressure wound dressings suitable for providing protection at the wound site may include: An absorbent layer for absorbing wound exudate; and A shielding element for at least partially shielding observation of the absorption layer absorbing wound exudate during use.

[0066] The masking element can be partially translucent.

[0067] The masking element can be a masking layer.

[0068] Non-negative pressure wound dressings may also include an area in or near a masking element to allow observation of the absorbent layer. For example, the masking element layer may be positioned above the central area of ​​the absorbent layer and not above the boundary area of ​​the absorbent layer. In some embodiments, the masking element is a hydrophilic material or coated with a hydrophilic material.

[0069] The masking element may include a three-dimensional knitted spacer fabric. Spacer fabrics are known in the art and may include layers of knitted spacer fabric.

[0070] The covering element may also include an indicator that indicates when the dressing needs to be changed.

[0071] In some embodiments, the shielding element is configured as a layer at least partially above the absorbent layer, and is further away from the wound site than the absorbent layer during use.

[0072] Non-negative pressure wound dressings may also include multiple openings in the shielding element to allow fluid to move through it. The shielding element may include a material with dimensional exclusion properties or may be coated thereon to selectively allow or prevent the passage of molecules of a predetermined size or weight.

[0073] The shielding element can be configured to at least partially shield light radiation with wavelengths of 600 nm and smaller.

[0074] The shielding element can be configured to reduce light absorption by 50% or more.

[0075] The masking element can be configured to produce a CIE L* value of 50 or greater, and optionally 70 or greater. In some embodiments, the masking element can be configured to produce a CIE L* value of 70 or greater.

[0076] In some embodiments, a non-negative pressure wound dressing may further include at least one of a wound contact layer, a foam layer, an odor control element, a pressure-resistant layer, and a covering layer.

[0077] In some embodiments, a covering layer is present, and the covering layer is a semi-transparent membrane. Typically, the semi-transparent membrane has a water vapor permeability of 500 g / m² / 24 hours or greater.

[0078] A semi-transparent membrane can act as a bacterial barrier.

[0079] In some embodiments, the non-negative pressure wound dressing as disclosed herein includes a wound contact layer, and an absorbent layer covers the wound contact layer. The wound contact layer carries an adhesive portion for forming a substantially fluid-impermeable, tight seal over the wound site.

[0080] Non-negative pressure wound dressings, as disclosed herein, may include a shielding element and an absorbent layer that is configured as a single layer.

[0081] In some embodiments, the non-negative pressure wound dressings disclosed herein include a foam layer, and the material of the shielding element includes components that may shift or break due to movement of the shielding element.

[0082] In some embodiments, the non-negative pressure wound dressing includes an odor control element; in another embodiment, the dressing does not include an odor control element. When an odor control element is present, it may be dispersed within or adjacent to an absorbent layer or a shielding element. Alternatively, when an odor control element is present, it may be a layer sandwiched between a foam layer and an absorbent layer.

[0083] In some embodiments, the disclosed technique for non-negative pressure wound dressings includes a method of manufacturing a wound dressing, comprising: providing an absorbent layer for absorbing wound exudate; and providing a shielding element for at least partially shielding, in use, from observation of the wound exudate absorbed by the absorbent layer.

[0084] In some embodiments, a non-negative pressure wound dressing may be adapted to provide protection at the wound site, comprising: an absorbent layer for absorbing wound exudate; and a shielding layer disposed above the absorbent layer and further away from the wound-facing side of the wound dressing than the absorbent layer. The shielding layer may be disposed directly above the absorbent layer. In some embodiments, the shielding layer comprises a three-dimensional spacer fabric layer.

[0085] The shielding layer increases the area over which pressure is applied to the dressing by 25% or more, or the initial application area. For example, the shielding layer increases the area over which pressure is applied to the dressing by 50% or more, optionally 100% or more, or optionally 200% or more.

[0086] The shielding layer may include two or more sublayers, wherein a first sublayer includes a via and another sublayer includes a via, and the via of the first sublayer is offset from the via of the other sublayer.

[0087] Non-negative pressure wound dressings disclosed herein may also include a permeable overlay for allowing gas and vapor to pass through it, the overlay being disposed above the shielding layer, wherein the perforations of the overlay are offset from the perforations of the shielding layer.

[0088] Non-negative pressure wound dressings can be used to treat pressure ulcers.

[0089] A more detailed description of the non-negative pressure dressings disclosed above is provided in WO2013007973, the entire contents of which are incorporated herein by reference.

[0090] In some embodiments, a non-negative pressure wound dressing may be a multilayer wound dressing, including: a fiber 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.

[0091] In some embodiments, the multilayer wound dressings disclosed herein further include a liquid-impermeable membrane layer, wherein a support layer is located between the absorbent layer and the membrane layer.

[0092] The support layer disclosed herein may include a mesh. The mesh may include a geometry having a plurality of generally geometrical apertures extending therethrough. For example, the geometry may include a plurality of tabs spaced substantially uniformly and joined by polymer strands to form generally geometrical apertures between the polymer strands.

[0093] The mesh can be formed from high-density polyethylene.

[0094] The pores may have an area of ​​0.005 mm² to 0.32 mm².

[0095] The support layer may have a tensile strength of 0.05 Nm to 0.06 Nm.

[0096] The support layer may have a thickness of 50 µm to 150 µm.

[0097] In some embodiments, a support layer is located immediately adjacent to the absorbent layer. Typically, the support layer is bonded to fibers in the top surface of the absorbent layer. The support layer may also include an adhesive layer, wherein the support layer is thermally laminated to the fibers in the absorbent layer via the adhesive layer. The adhesive layer may include a low-melting-point adhesive, such as ethylene-vinyl acetate adhesive.

[0098] In some embodiments, the multilayer wound dressings disclosed herein further include an adhesive layer for attaching the membrane layer to the support layer.

[0099] In some embodiments, the multilayer wound dressings disclosed herein further include a wound contact layer positioned adjacent to the absorbent layer for positioning adjacent to the wound. The multilayer wound dressing may also include a fluid transport layer between the wound contact layer and the absorbent layer for delivering exudate away from the wound into the absorbent layer.

[0100] A more detailed description of the multilayer wound dressing disclosed above is provided in UK Patent Application GB1618298.2, filed on 28 October 2016, the entire contents of which are incorporated herein by reference.

[0101] In some embodiments, the disclosed technology can be incorporated into wound dressings comprising vertically overlapping materials, the wound dressing including: a first absorbent material layer and a second material layer, wherein the first layer consists of at least one layer of nonwoven textile fibers folded into multiple pleats to form a pleated structure. In some embodiments, the wound dressing further includes a second material layer temporarily or permanently attached to the first material layer.

[0102] Typically, vertically overlapping materials have been cut.

[0103] In some embodiments, the first layer has a pleated structure having a depth determined by the pleat depth or by the cut width. The first layer material may be a moldable lightweight fiber-based material, a blend of materials, or a composite layer.

[0104] The first layer material may include one or more of fibers made from synthetic natural or inorganic polymers, cellulose, protein, or mineral-derived natural fibers.

[0105] Wound dressings may include two or more layers of absorbent material stacked on top of other materials, wherein the two or more layers have the same or different densities or compositions.

[0106] In some embodiments, the wound dressing may consist of only one layer of absorbent material with vertically overlapping layers.

[0107] The absorbent material layer is a blend of natural or synthetic, organic or inorganic fibers and binder fibers or bicomponent fibers. The bicomponent fibers are typically PET with a low melting temperature PET coating to soften at a specified temperature and act as a binder throughout the blend.

[0108] In some embodiments, the absorbent material layer may be a blend of 5% to 95% thermoplastic polymer and 5% to 95% by weight cellulose or its derivatives.

[0109] In some embodiments, the wound dressing disclosed herein has a second layer comprising foam or dressing fixative.

[0110] The foam can be polyurethane foam. Polyurethane foam can have an open-cell or closed-cell structure.

[0111] Dressing fixation materials may include bandages, tape, mesh, or backing layers.

[0112] In some embodiments, the wound dressing disclosed herein includes an absorbent material layer directly attached to a second layer by lamination or by an adhesive, and the second layer is attached to a dressing fixation layer. The adhesive may be an acrylic adhesive or a silicone adhesive.

[0113] In some embodiments, the wound dressings disclosed herein further include a superabsorbent fiber layer, or a viscose fiber layer, or a polyester fiber layer.

[0114] In some embodiments, the wound dressings disclosed herein also include a backing layer. The backing layer may be a transparent or opaque film. Typically, the backing layer comprises a polyurethane film (usually a transparent polyurethane film).

[0115] A more detailed description of the multilayer wound dressing disclosed above is provided in UK Patent Application No. GB1621057.7, filed on 12 December 2016, and UK Patent Application No. GB1709987.0, filed on 22 June 2017, the entire contents of which are incorporated herein by reference.

[0116] In some embodiments, a non-negative pressure wound dressing may include an absorbent component for the wound dressing, the component including a wound contact layer comprising gel-forming fibers bonded to a foam layer, wherein the foam layer is bonded to the wound contact layer directly by an adhesive, a polymer-based melt layer, flame lamination, or ultrasound.

[0117] The absorbent component can be in sheet form.

[0118] The wound contact layer may include a woven or nonwoven or knitted gel-formed fiber layer.

[0119] The foam layer can be open-cell or closed-cell foam, but is usually open-cell foam. The foam layer is hydrophilic foam.

[0120] Wound dressings may include components that form islands that come into direct contact with a wound, the wound being surrounded by an adhesive to which the dressing is applied. The adhesive may be a silicone or acrylic adhesive, typically a silicone adhesive.

[0121] Wound dressings can be covered by a membrane layer on the dressing surface furthest from the wound.

[0122] A more detailed description of this type of wound dressing described above is provided in EP2498829, the entire contents of which are incorporated herein by reference.

[0123] In some embodiments, a non-negative pressure wound dressing may include a multilayer wound dressing for generating high levels of exudate in a wound, characterized in that the dressing comprises: a transport layer having a MVTR of at least 300 gm² / 24 hours; an absorbent core including gel-forming fibers capable of absorbing and retaining exudate; a wound contact layer including gel-forming fibers that transport exudate to the absorbent core; and a bonding layer positioned on the absorbent core, the absorbent core and the wound contact layer limiting the lateral diffusion of exudate in the dressing to the wound area.

[0124] The wound dressing is capable of handling at least 6 g (or 8 g and 15 g) of fluid / 10 cm2 within 24 hours.

[0125] Wound dressings may include gel-forming fibers, which are chemically modified cellulose fibers in the form of fabrics. The fibers may include carboxymethylated cellulose fibers, typically sodium carboxymethyl cellulose fibers.

[0126] Wound dressings may include a wound contact layer having a lateral wicking rate of 5 mm / min to 40 mm / min. The wound contact layer may have a fiber density between 25 gm² and 55 gm², for example, 35 gm².

[0127] The absorbent core may have an exudate absorption capacity of at least 10 g / g and typically a lateral wicking rate of less than 20 mm / min.

[0128] The absorbent core may have a blend of up to 25% by weight cellulose fibers and 75% to 100% by weight gel-forming fibers.

[0129] Alternatively, the absorbent core may have a blend of up to 50% by weight cellulose fibers and 50% to 100% by weight gel-forming fibers. For example, the blend may be in the range of 50% by weight cellulose fibers and 50% by weight gel-forming fibers.

[0130] The fiber density in the absorbent core can be between 150 gm2 and 250 gm2, or about 200 gm2.

[0131] When moistened, the shrinkage rate of the wound dressing can be less than 25% or less than 15% of its original size / dimension.

[0132] Wound dressings may include a delivery layer, and this layer is foam. The delivery layer may be a polyurethane foam laminated to a polyurethane membrane.

[0133] Wound dressings may include one or more layers selected from the group consisting of a soluble drug film layer, an odor-absorbing layer, a diffusion layer, and an additional adhesive layer.

[0134] Wound dressings can be 2 mm or 4 mm thick.

[0135] The wound dressing may be characterized by a bonding layer that bonds an absorbent core to an adjacent layer. In some embodiments, the bonding layer may be located on the wound-facing side of the absorbent core or on the non-wound-facing side of the absorbent core. In some embodiments, the bonding layer is located between the absorbent core and the wound contact layer. The bonding layer is a polyamide web.

[0136] A more detailed description of this type of wound dressing described above is provided in EP1718257, the entire contents of which are incorporated herein by reference.

[0137] In some embodiments, non-negative pressure wound dressings may be compression bandages. Compression bandages are known to be used to treat, for example, edema of the lower extremities and other venous and lymphatic diseases.

[0138] Compression bandage systems typically employ multiple layers, including layers of skin and compression layers, or padding layers between the layers. Compression bandages can be used for wounds such as those treating venous leg ulcers.

[0139] In some embodiments, a compression bandage may include a bandage system comprising an inner layer of skin and an elastic outer layer, the inner layer comprising a first foam sheet and a second sheet of absorbent nonwoven mesh, the inner and outer layers being sufficiently elongated to be wrapped around a patient's limb. This type of compression bandage is disclosed in WO99 / 58090, the entire contents of which are incorporated herein by reference.

[0140] In some embodiments, the compression bandage system includes: a) an internal elongated elastic bandage facing the skin, comprising: (i) an elongated elastic substrate, and (ii) an elongated foam layer adhered to one side of the substrate and extending 33% or more across the surface of the substrate in the transverse direction and 67% or more across the surface of the substrate in the longitudinal direction; and b) an outer elongated self-adhesive elastic bandage having compressive force when extended; wherein, in use, the foam layer of the inner bandage faces the skin, and the outer bandage covers the inner bandage. This type of compression bandage is disclosed in WO2006 / 110527, the entire contents of which are incorporated herein by reference.

[0141] In some embodiments, other compression bandage systems, such as those disclosed in US 6,759,566 and US 2002 / 0099318, the entire contents of which are hereby incorporated by reference.

[0142] negative pressure wound dressing In some embodiments, negative pressure wound therapy may be used to treat such wounds, wherein decompression or negative pressure may be applied to the wound to facilitate and promote wound healing. It will also be appreciated that wound dressings and methods described herein can be applied to other parts of the body and are not necessarily limited to wound treatment.

[0143] It should be understood that the embodiments of this disclosure are generally applicable to local negative pressure (“TNP”) treatment systems. In simple terms, negative pressure wound therapy helps close and heal various forms of “difficult-to-heal” wounds by reducing tissue edema, promoting blood flow and granulation tissue formation, removing excess exudate, and reducing bacterial load (thereby lowering the risk of infection). Furthermore, this therapy allows for less disturbance to the wound, resulting in faster healing. TNP treatment systems can also assist in the healing of surgically closed wounds by removing fluid and by helping to stabilize tissue immediately adjacent to the closure site. Further beneficial uses of TNP treatment can be found in grafts and flaps, where removing excess fluid is important and grafts need to be extremely close to the tissue to ensure tissue viability.

[0144] Negative pressure therapy can be used to treat open or chronic wounds that are too large to close spontaneously or otherwise heal by applying negative pressure to the wound site. Topical negative pressure (TNP) therapy, or negative pressure wound therapy (NPWT), involves placing a fluid-impermeable or semi-permeable covering over the wound, sealing the covering to the patient's tissues around the wound using various methods, and connecting a negative pressure source (such as a vacuum pump) to the covering in a manner that generates and maintains negative pressure beneath it. This negative pressure is believed to promote wound healing by facilitating the formation of granulation tissue at the wound site and aiding the body's normal inflammatory processes while removing excess fluid that may contain harmful cytokines or bacteria.

[0145] Some dressings used in NPWT can include many different types of materials and layers, such as gauze, padding, foam pads, or multi-layer wound dressings. An example of a multi-layer wound dressing is the PICO dressing, available from Smith & Nephew, which includes a wound contact layer beneath a backing layer and a superabsorbent layer to provide a canister-free system for treating wounds with NPWT. The wound dressing can be sealed to an aspiration port that provides connection to a tubing of a certain length for pumping fluid out of the dressing or transferring negative pressure from a pump to the wound dressing. Additionally, RENASYS-F, RENASYS-G, RENASYS-AB, and RENASYS-F / AB, available from Smith & Nephew, are additional examples of NPWT wound dressings and systems. Another example of a multi-layer wound dressing is the ALLEVYN Life dressing, available from Smith & Nephew, which includes a wet wound environment dressing for treating wounds without the use of negative pressure.

[0146] As used herein, a decompression level or negative pressure level (such as -X mmHg) represents a pressure level relative to normal ambient atmospheric pressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Therefore, a negative pressure value of -X mmHg reflects an absolute pressure X mmHg lower than 760 mmHg, or in other words, reflects an absolute pressure of (760-X) mmHg. Furthermore, a negative pressure "lower" or "smaller" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40 mmHg is smaller than -60 mmHg). A negative pressure "higher" or "larger" than -X mmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80 mmHg is larger than -60 mmHg). In some embodiments, a local ambient atmospheric pressure is used as a reference point, which does not necessarily have to be, for example, 760 mmHg.

[0147] In some embodiments of this disclosure, the negative pressure range may be about -80 mmHg, or between about -20 mmHg and -200 mmHg. It should be noted that these pressures are based on normal ambient atmospheric pressure (which may be 760 mmHg). Therefore, in practice, -200 mmHg would be about 560 mmHg. In some embodiments, the pressure range may be between about -40 mmHg and -150 mmHg. Alternatively, pressure ranges up to -75 mmHg, up to -80 mmHg, or exceeding -80 mmHg may be used. Additionally, in other embodiments, pressure ranges below -75 mmHg may be used. Alternatively, the negative pressure device may supply pressure ranges exceeding about -100 mmHg, or even -150 mmHg.

[0148] In some embodiments of the wound closure device described herein, increased wound contraction can cause increased tissue expansion in the surrounding wound tissue. This effect can be enhanced by altering the force applied to the tissue (e.g., by altering the negative pressure applied to the wound over time), which may be combined with increased tension applied to the wound via embodiments of the wound closure device. In some embodiments, the negative pressure can be altered over time, for example, using a sine wave, a square wave, or synchronized with one or more patient physiological indicators (e.g., heart rate). Examples of such applications in which additional disclosures relating to the foregoing can be found include U.S. Patent No. 8,235,955, published August 7, 2012, entitled “Wound treatment apparatus and method”; and U.S. Patent No. 7,753,894, published July 13, 2010, entitled “Wound cleansing apparatus with stress”. The disclosures of both patents are incorporated herein by reference in their entirety.

[0149] The embodiments of wound dressings, wound dressing components, wound treatment devices, and methods described herein may also be used in combination with or in conjunction with those described in the following documents: International Application No. PCT / IB2013 / 001469, entitled “Apparatus and Methods for Negative Pressure Wound Therapy”, filed May 22, 2013 and published November 28, 2013, as WO 2013 / 175306 A2; and U.S. Patent Application No. 14 / 418,908, entitled “Wound Dressing and Method of Treatment”, filed January 30, 2015 and published July 9, 2015, as US 2015 / 0190286 A1, the disclosures of which are incorporated herein by reference in their entirety. The embodiments of wound dressings, wound dressing components, wound treatment devices, and methods described herein may also be used in combination with or in conjunction with those described in U.S. Patent Application No. 13 / 092,042, entitled "Wound Dressing and Method of Use," filed April 21, 2011, entitled US2011 / 0282309, and U.S. Patent Application No. 14 / 715,527, entitled "FLUIDIC CONNECTOR FORNEGATIVE PRESSURE WOUND THERAPY," filed May 18, 2015, and published November 24, 2016, entitled US2016 / 0339158 A1. The disclosures of the aforementioned patents are incorporated herein by reference in their entirety, including further details regarding embodiments of wound dressings, wound dressing components, and principles, as well as materials for wound dressings.

[0150] Furthermore, some embodiments of TNP wound management involving wound dressings that combine with the pump and / or associated electronics described herein may also be used in combination with or in supplement to those described in international application PCT / EP2016 / 059329 entitled “Reduced Pressure Apparatus and Methods”, filed on April 26, 2016 and published on November 3, 2016 as WO 2016 / 174048, the disclosure of which is hereby incorporated by reference in its entirety.

[0151] Wound monitoring and treatment system using sensors Figure 1AA wound monitoring and treatment system 10 according to some embodiments is illustrated. The system includes a wound dressing 22 implementing sensors connected to a controller 24. As described herein, the dressing 22 may be placed on or within a patient's wound and may utilize various sensors embedded or otherwise placed within the dressing 22 to acquire measurement data from one or more of the wound or surrounding areas (e.g., the peri-wound area). The controller 24 may receive, store, and process the data acquired by the dressing 22. To facilitate communication, the dressing 22 may include one or more communication modules, such as one or more antennas as described herein. In some cases, the controller 24 may transmit one or more commands and data to the dressing 22.

[0152] In some embodiments, the wound dressing 22 may be disposable, and the controller 24 may be reusable. In some embodiments, the wound dressing 22 may be reusable. In some embodiments, the wound dressing 22 may be resterilized or otherwise purified or sterilized. In some embodiments, the controller 24 may be disposable. In some embodiments, the wound dressing 22 and the controller 24 may be permanently connected, and the combined wound dressing and control box may be disposable, reusable, or resterilized or otherwise purified or sterilized. The controller 24 may include a power source (e.g., a battery), one or more processors, one or more storage elements, and communication devices. In some embodiments, the controller 24 may include one or more sensors, such as temperature sensors or optical sensors, to acquire information about the patient or environmental conditions away from the location of the wound dressing. In some embodiments, one or more sensors of the controller 24 may include an accelerometer, motion sensor, or gyroscope. In some embodiments, the wound dressing 22 may include one or more indicators to transmit information to a user. The indicators may be visual, audible, tactile, or touch-sensitive. The transmitted information may include measurement data, wound status, etc.

[0153] The controller 24 can transmit data to the communication device 30 on demand, periodically, etc. When the communication device is within communication range, communication can be performed via a wired or wireless interface, such as via Near Field Communication (NFC), RFID, etc. For example, the communication range can be extremely close to the controller 24, for example, within approximately 3 cm or less or more. The communication device 30 can be placed within communication range by a clinician (e.g., during initialization and at the end of treatment). The controller 24 can respond to commands requesting data from the communication device 30 with data. The communication device 30 can be connected to a computing device 40 via a wired or wireless interface, such as a personal computer, tablet, smartphone, etc. For example, a wired USB protocol can be used to transfer data between devices 30 and 40. The computing device 40 can further process the data collected by the dressing 22. For example, the computing device 40 can summarize the data collected from the dressing 22 and the infusion determining device 70, which is configured to determine skin infusion pressure, and transmit the data to the computing device 40 via a wired or wireless interface. For example, a wired USB protocol can be used for communication between devices 70 and 40.

[0154] Computing device 40 may be configured to communicate with remote computing device 50, which stores and processes medical data, via a wired or wireless interface. In some embodiments, remote computing device 50 may be a cloud computing device, including one or more remote storage devices, servers, processing devices, or any information storage devices. For example, remote computing device 50 may process and store medical data in accordance with one or more applicable security and privacy standards, such as the Health Insurance Portability Act (HIPPA), the EU Data Protection Directive, etc. Remote computing device 50 may make data provided by one or more of computing device 40 or mobile device 60 available for remote access and viewing, for example, access and viewing on mobile device 60. In some embodiments, additional data may be added to be stored on remote computing device 50. For example, mobile device 60 may add additional data via a dedicated application, web browser interface, etc. Remote computing device 50 may process data from one or more of wound dressing 22, irrigation determination device 70, or mobile device, and evaluate or determine treatment plans, such as suggesting or adjusting one or more treatment therapies.

[0155] As described herein, mobile device 60 can capture one or more images of a patient's wound. This data can be transmitted to remote computing device 50 via a wired or wireless interface. Although a smartphone is illustrated, mobile device 60 can be any suitable computing device that includes imaging capabilities such as a camera. Mobile device 60 can also collect additional data, such as data entered by healthcare providers in response to questionnaires.

[0156] More detailed description is provided in other parts of this disclosure. Figure 1A The various components are shown in the diagram.

[0157] Figure 1B The use of a wound monitoring and treatment system (e.g., system 10) according to some embodiments is illustrated. As shown in boxes 1101 and 1103, a user (such as a healthcare provider (HCP)) can provide information about a patient's medical history and lifestyle. Such information can be provided via mobile device 60 and stored on a telecomputing device 50 as described herein (e.g., via an application). In box 1106, wound assessment can be performed. For example, mobile device 60 can capture an image of the wound and upload it to the telecomputing device 50 as described herein. Alternatively or additionally, skin perfusion pressure can be measured by device 70 and uploaded to the telecomputing device 50 as described herein.

[0158] In box 1108, the user's treatment decisions can be recorded. For example, one or more treatment therapies, such as negative pressure wound therapy, can be selected. In box 1110, additional images of the cleaned (if applicable) and debrided wound can be captured and uploaded to a remote computing device. In box 1112, the wound dressing 22 can be placed in or on the patient's wound. In box 1114, if the wound dressing and controller are separate, the controller 24 can be connected to the wound dressing 22. The wound dressing can be initialized as described herein. In box 1116, one or more selected therapies can be applied. In block 1118, images of the wound covered by the wound dressing 22 can be captured and uploaded. In box 1120, measurement data from the wound dressing 22 can be acquired and stored as described herein. This step can be performed as appropriate multiple times while the wound dressing 22 is applied to the patient. After treatment is completed, in block 1122, the measurement data can be uploaded to the remote computing device 50 as described herein. In box 1124, images of the healed wound can be captured.

[0159] In some embodiments, the Euler magnification technique described in the following documents may be used to process one or more images of a wound: International Patent Application No. PCT / EP2018 / 062207, filed May 11, 2018, entitled “NEGATIVE PRESSURE WOUND THERAPY SYSTEMUSING EULERIAN VIDEO MAGNIFICATION,” which claims priority to U.S. Provisional Patent Application No. 62 / 506,524, filed May 15, 2017, entitled “NEGATIVE PRESSURE WOUND THERAPY SYSTEM USING EULERIAN VIDEO MAGNIFICATION”; and International Patent Application No. PCT / EP2018 / 062206, filed May 11, 2018, entitled “WOUND ANALYSIS DEVICE AND METHOD,” which claims priority to U.S. Provisional Patent Application No. 62 / 506,524, filed May 15, 2017, entitled “WOUND ANALYSIS DEVICE AND METHOD.” Priority is claimed in U.S. Provisional Patent Application No. 62 / 506,551, “METHOD”, each of which is incorporated herein by reference in its entirety. Euler amplification techniques can be implemented by any component of system 10, such as mobile device 60 or remote computing device 50.

[0160] Wound dressings with sensors Figure 1CA wound dressing 22 implementing sensors according to some embodiments is illustrated. As described herein, the wound dressing 22 may include a substantially flexible substrate, which may include a wound contact layer having one or more characteristics of any wound contact layer described herein. As used herein, “wound contact layer” may imply the wound contact layer together with the substrate, and “substrate” may imply both the substrate and the wound contact layer together. The wound dressing 22 may include any of the wound dressing layers described herein. The entire wound dressing 22 may be substantially flexible. As shown, one or more sensors 26 connected by one or more electronic connections or tracks 27 are positioned or embedded in the wound dressing 22. In some embodiments, one or more sensors of the wound dressing 22 may measure one or more of impedance, temperature, optical properties, etc. In some embodiments, one or more sensors of the wound dressing 22 or any other wound dressing disclosed herein may measure one or more of the following: impedance, temperature, pH, pressure (e.g., by using a strain gauge), tissue elasticity (e.g., by using an ultrasonic sensor, piezoelectric transducer, etc.), blood flow (e.g., by measuring the Doppler effect), color, or light. One or more sensors may be electronic or non-electronic. Examples of non-electronic sensors include sensors that change color based on pH or when stretched, strained, or otherwise stressed. Measurements from such sensors can be obtained through visual monitoring, which can be performed automatically, for example, by using a camera or by using one or more optical sensors. One or more sensors and connections can be positioned on the wound contact layer. A connector 28 for connecting the wound dressing 22 to the controller 24 is also illustrated. Connector 28 includes one or more electrical connections or traces. In some embodiments, the boundaries or edges of the wound contact layer can be smoothed by cutting, having a smooth profile, including fibers, etc., to improve patient comfort.

[0161] In some embodiments, the dressing may include one or more antennas for wireless communication. For example, one or more antennas may be printed as one or more connections or traces on the wound contact layer. In the absence of controller 24, the one or more antennas may be used to transmit measurement data acquired by one or more sensors. The one or more antennas may also be used to wirelessly receive power from a power source. In some cases, the one or more antenna traces may be positioned on a substantially non-stretchable material (as described herein) such that the resonant frequency of the one or more antennas remains fixed when the wound dressing 22 is placed under stress when used on a patient. For certain communication protocols, such as RFID, fixing one or more resonant frequencies may be advantageous.

[0162] Negative pressure wound therapy system Figure 2AAn embodiment of a negative pressure or decompression wound treatment (or TNP) system 100 is illustrated, comprising a wound filler 130 placed within a wound cavity 110, the wound cavity being sealed by a wound covering 120. The combination of the wound filler 130 and the wound covering 120 may be referred to as a wound dressing. The wound dressing may include one or more sensors as described herein. A single-lumen or multi-lumen tube or conduit 140 is connected to the wound covering 120, wherein a pump assembly 150 is configured to supply reduced pressure. The wound covering 120 may be in fluid communication with the wound cavity 110. In any system embodiment disclosed herein, such as Figure 2A In the illustrated embodiments, the pump assembly may be a tankless pump assembly (meaning exudate is collected in the wound dressing or delivered via tube 140 for collection at another location). However, any pump assembly embodiment disclosed herein may be configured to include or support a tank. Additionally, in any system embodiment disclosed herein, any pump assembly embodiment may be mounted to or supported by the dressing, or adjacent to the dressing.

[0163] Wound packing 130 can be of any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bags, etc. Wound packing 130 can conform to the oral cavity 110 such that it substantially fills the cavity. Wound covering 120 can provide a substantially fluid-impermeable seal over the oral cavity 110. Wound covering 120 can have a top side and a bottom side, and the bottom side is adhesively (or in any other suitable manner) sealed to the oral cavity 110. The conduit 140 or lumen, or any other conduit or lumen disclosed herein, can be formed of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

[0164] Some embodiments of the wound covering 120 may have a port (not shown) configured to receive the end of the conduit 140. For example, the port may be a Renays Soft Port available from Smith & Nephew. In other embodiments, the conduit 140 may otherwise pass through or beneath the wound covering 120 to supply reduced pressure to the wound cavity 110 in order to maintain a desired reduced pressure level in the wound cavity. The conduit 140 may be any suitable article configured to provide at least substantially sealed fluid flow path between the pump assembly 150 and the wound covering 120 in order to supply reduced pressure provided by the pump assembly 150 to the wound cavity 110.

[0165] Wound covering 120 and wound filler 130 may be provided as individual articles or as an integral single unit. In some embodiments, wound filler is not provided, and the wound covering itself may be considered as a wound dressing. The wound dressing may then be connected via conduit 140 to a negative pressure source, such as a pump assembly 150. The pump assembly 150 may be miniaturized or portable, but larger conventional pumps may also be used.

[0166] Wound covering 120 may be positioned above the wound site to be treated. Wound covering 120 may form a substantially sealed cavity or enclosure above the wound site. In some embodiments, wound covering 120 may be configured to have a membrane with high water vapor permeability to allow excess fluid to evaporate, and may have a superabsorbent material contained therein to safely absorb wound exudate. It should be recognized that the term wound is referred to throughout the specification. In this sense, the term wound should be understood to be broadly interpreted and to encompass both open and closed wounds where the skin is torn, cut, or punctured, or where trauma has caused contusion, or any other surface or other condition or defect on the patient's skin, or those wounds that benefit from decompression therapy. Thus, wound is broadly defined as any damaged tissue area that may or may not produce fluid. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical incisions and other incisions, subacute and laceration wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic injuries, and venous ulcers. The components of the TNP system described herein are particularly suitable for incisions that dissipate small amounts of wound exudate.

[0167] Some embodiments of the system are designed to operate without the use of an exudate tank. Some embodiments may be configured to support an exudate tank. In some embodiments, the pump assembly 150 and tubing 140 are configured such that tubing 140 can be quickly and easily removed from the pump assembly 150, which may facilitate or improve the dressing or pump change process, if necessary. Any pump embodiment disclosed herein may be configured to have any suitable connection between the tubing and the pump.

[0168] In some embodiments, pump assembly 150 may be configured to deliver a negative pressure of approximately -80 mmHg, or between approximately -20 mmHg and 200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure; therefore, -200 mmHg would actually be approximately 560 mmHg. The pressure range may be between approximately -40 mmHg and -150 mmHg. Alternatively, pressure ranges up to -75 mmHg, up to -80 mmHg, or exceeding -80 mmHg may be used. Additionally, pressure ranges below -75 mmHg may be suitable. Alternatively, pump assembly 150 may supply pressure ranges exceeding approximately -100 mmHg or even 150 mmHg.

[0169] In operation, a wound packing 130 is inserted into the wound cavity 110, and a wound covering 120 is placed to seal the wound cavity 110. A pump assembly 150 provides a negative pressure source to the wound covering 120, which is then transported to the wound cavity 110 via the wound packing 130. Fluid (e.g., wound exudate) is aspirated through a conduit 140 and can be stored in a container. In some embodiments, the fluid is absorbed by the wound packing 130 or one or more absorbent layers (not shown).

[0170] Wound dressings that can 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 therapy systems that can be used with the pump assembly and other embodiments of this application can be found in U.S. Patent Publications 2011 / 0213287, 2011 / 0282309, 2012 / 0116334, 2012 / 0136325, and 2013 / 0110058, which are incorporated herein by reference in their entirety. In other embodiments, other suitable wound dressings may be used.

[0171] Overview of wound dressings Figure 2B The illustration shows a cross-section of the wound dressing 155 according to some embodiments. Figure 2BA fluid connector 160 according to some embodiments is also illustrated. Wound dressing 155 may be similar to the wound dressing described in International Patent Publication WO2013175306 A2, which is incorporated herein by reference in its entirety. Alternatively, wound dressing 155 may be any combination of features of any wound dressing embodiment disclosed herein or any number of wound dressing embodiments disclosed herein, and may be positioned above the wound site to be treated. Wound dressing 155 may be positioned to form a sealed cavity above the wound, such as wound cavity 110. In some embodiments, wound dressing 155 includes a top layer or overlay, or a backing layer 220 attached to an optional wound contact layer 222, both of which are described in more detail below. These two layers 220, 222 are preferably connected or sealed together to define an internal space or chamber. This internal space or chamber may include additional structures adapted to distribute or transmit negative pressure, store wound exudate and other fluids removed from the wound, and other functions, which will be explained in more detail below. Examples of such structures described below include a transport layer 226 and an absorbent layer 221.

[0172] As used in this article, the upper layer, top layer, or above layer refers to the layer furthest from the surface of the skin or wound when the dressing is in use and positioned above the wound. Therefore, the lower surface, lower layer, bottom layer, or below layer refers to the layer closest to the surface of the skin or wound when the dressing is in use and positioned above the wound.

[0173] The wound contact layer 222 may be a polyurethane layer, a polyethylene layer, or other flexible layer, which may be perforated, for example, by heat-pressing, laser ablation, ultrasonication, or some other method, or additionally 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 away from the wound). Perforations 225 preferably 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 from growing inward into other materials of the wound dressing. In some embodiments, the perforations are small enough to meet this requirement while still allowing fluid to flow through them. For example, perforations formed as slits or holes ranging in size from 0.025 mm to 1.2 mm are considered small enough to help prevent tissue from growing inward 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 at the wound site. In some embodiments, the wound contact layer is configured to allow fluid to flow unidirectionally or substantially unidirectionally or in one direction across the wound contact layer when negative pressure is applied to the wound. For example, the wound contact layer may allow fluid to flow away from the wound but not back towards the wound. In some cases, perforations in the wound contact layer are configured to allow such unidirectional or in one-way fluid flow across the wound contact layer.

[0174] Some embodiments of the wound contact layer 222 may also serve as a carrier for optional lower and upper adhesive layers (not shown). For example, a lower pressure-sensitive adhesive may be disposed on the lower surface 224 of the wound dressing 155, while an upper pressure-sensitive adhesive layer may be disposed on the upper surface 223 of the wound contact layer. The pressure-sensitive adhesive may be a silicone-based, hot-melt, hydrocolloid, or acrylic adhesive, or other such adhesive, and may be formed on both sides of the wound contact layer, or optionally on a selected side of both sides of the wound contact layer, or not on either side. Using the lower pressure-sensitive adhesive layer can help adhere the wound dressing 155 to the skin around the wound site. In some embodiments, the wound contact layer may include a perforated polyurethane membrane. The lower surface of the membrane may be provided with a silicone pressure-sensitive adhesive, and the upper surface may be provided with an acrylic pressure-sensitive adhesive, which can help the dressing maintain its integrity. In some embodiments, a polyurethane membrane layer may be provided with adhesive layers on its upper and lower surfaces, and all three layers may be perforated together.

[0175] A porous material layer 226 may be located above the wound contact layer 222. This porous layer, or transport layer 226, allows fluids, including liquids and gases, to be transported away from the wound site and into the upper layer of the wound dressing. In particular, the transport layer 226 ensures that open air channels are maintained to deliver negative pressure over the wound area even when the absorbent layer absorbs large amounts of exudate. Layer 226 can remain open under the typical pressure applied during negative pressure wound therapy as described above, so that uniform negative pressure is seen throughout the wound site. Layer 226 may be formed of a material with a three-dimensional structure. For example, knitted or woven spacer fabrics (e.g., Baltex 7970 weft-knitted polyester) or non-woven fabrics may be used.

[0176] In some embodiments, the transport layer 226 comprises a 3D polyester spacer fabric layer including a top layer (i.e., the layer furthest from the wound bed in use), which is an 84 / 144 textured polyester, and a bottom layer (i.e., the layer closest to the wound bed in use), which is a 10-denier flat polyester, and a third layer sandwiched between the two layers, the third layer being a region defined by knitted polyester viscose, cellulose, or similar monofilament fibers. Of course, other materials and fibers of other linear mass densities can be used.

[0177] Although monofilament fibers are referred to throughout this disclosure, it should be understood that multi-ply alternatives may, of course, be used. Therefore, the top spacer fabric has a greater number of filaments in the yarns used to form it than the yarns constituting the bottom spacer fabric layers.

[0178] This difference in the number of filaments between the spaced-out layers helps control the flow of moisture through the transport layer. Specifically, by having a larger number of filaments in the top layer—that is, by making the top layer with more filaments than the yarn used in the bottom layer—liquid tends to be wicked up more along the top layer than the bottom layer. In use, this difference tends to draw fluid away from the wound bed and into the central area of ​​the dressing, where the absorbent layer 221 helps to lock the fluid away or wicks it forward toward the liquid-evaporable covering layer.

[0179] In some embodiments, to improve liquid flow through transport layer 226 (i.e., perpendicular to the channel region formed between the top and bottom spacers), the 3D fabric can be treated with a dry cleaning agent (e.g., but not limited to, perchloroethylene) to help remove any manufacturing byproducts, such as previously used mineral oils, greases, or waxes, which may interfere with the hydrophilicity of the transport layer. Subsequently, an additional manufacturing step may be performed in which the 3D spacer fabric is washed in a hydrophilic agent (e.g., but not limited to, Feran Ice 30 g / l available from Rudolph Group). This process step helps ensure that the surface tension on the material is very low, allowing liquids such as water to penetrate the fabric upon contact with the 3D knitted fabric. This also helps control the flow of any exudate or liquid soiling components.

[0180] An absorbent material layer 221 may be disposed above the transport layer 226. This absorbent material, including foam or nonwoven natural or synthetic materials, and optionally including superabsorbent materials, forms a reservoir for removing fluids (particularly liquids) from the wound site. In some embodiments, layer 221 may also facilitate the absorption of fluids toward the backing layer 220.

[0181] The material of absorbent layer 221 also prevents fluid collected in wound dressing 155 from flowing freely within the dressing and can be used to contain any fluid collected within the dressing. Absorbent layer 221 also facilitates the distribution of fluid throughout the layer via wicking, so that fluid is absorbed from the wound site and stored throughout the absorbent layer. This helps prevent accumulation in areas of the absorbent layer. The capacity of the absorbent material must be sufficient to manage the flow rate of exudate from the wound when negative pressure is applied. Because the absorbent layer experiences negative pressure during use, the material of the absorbent layer is selected to absorb fluid under these conditions. Many materials are available that can absorb fluid under negative pressure, such as superabsorbent materials. Absorbent layer 221 is typically made of ALLEVYN™ foam, Freudenberg 114-224-4, or Chem-Posite™ 11C-450. In some embodiments, absorbent layer 221 may comprise a composite material comprising superabsorbent powder, fibrous materials such as cellulose, and bonded fibers. In some embodiments, the composite is an air-laid thermally bonded composite.

[0182] In some embodiments, the absorbent layer 221 is a nonwoven cellulose fiber layer having a superabsorbent material in the form of dry particles dispersed throughout. The use of cellulose fibers introduces a rapid wicking element, which facilitates the rapid and uniform distribution of liquid absorbed by the dressing. The juxtaposition of the multi-stranded fibers results in strong capillary action in the fiber pad, which aids in liquid distribution. In this way, the superabsorbent material is effectively supplied with liquid. The wicking action also helps to bring the liquid into contact with the overlying layer, thereby helping to increase the evaporation rate of the dressing.

[0183] An orifice, hole, or pore 227 may be provided in the backing layer 220 to allow negative pressure to be applied to the dressing 155. In some embodiments, a fluid connector 160 is attached or sealed to the top of the backing layer 220 above the pore 227 created in the dressing 155 and transmits negative pressure via the pore 227. A length of tubing may be coupled to the fluid connector 160 at a first end and to a pump unit (not shown) at a second end to allow fluid to be pumped out of the dressing. In cases where the fluid connector adheres to the top layer of the wound dressing, a length of tubing may be coupled to the first end of the fluid connector such that the tubing or conduit extends parallel to or substantially to the top surface of the dressing away from the fluid connector. Using an adhesive, such as acrylic, cyanoacrylate, epoxy, UV-curable, or hot-melt adhesive, the fluid connector 160 may adhere to and seal to the backing layer 220. The fluid connector 160 may be formed of a soft polymer, such as polyethylene, polyvinyl chloride, silicone, or polyurethane, with a Shore A hardness of 30 to 90. In some embodiments, the fluid connector 160 may be made of a soft or conformal material.

[0184] In some embodiments, the absorbent layer 221 includes at least one through-hole 228 positioned to facilitate its location 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. Figure 2B As shown, a single through-hole can be used to create an opening located below the fluid connector 160. It will be appreciated that multiple openings can be used alternatively. Additionally, if more than one port is used according to certain embodiments of this disclosure, one or more openings can be created in the absorption layer and shielding layer calibrated with each respective fluid connector. While not essential for certain embodiments of this disclosure, the use of through-holes in the superabsorption layer provides a fluid flow path that remains unobstructed, particularly when the absorption layer is near saturation.

[0185] like Figure 2BAs shown, the orifice or through-hole 228 can be provided in the absorbent layer 221 below the pore 227, such that the pore is directly connected to the transport layer 226. This allows the negative pressure applied to the fluid connector 160 to communicate with the transport layer 226 without passing through the absorbent layer 221. This ensures that the negative pressure applied to the wound site is not suppressed by the absorbent layer as it absorbs wound exudate. In other embodiments, no orifice may be provided in the absorbent layer 221, or multiple orifices may be provided below the orifice 227. In other alternative embodiments, an additional layer (e.g., another transport layer or shielding layer as described in International Patent Publication WO2014020440, which is incorporated herein by reference in its entirety) may be provided above the absorbent layer 221 and below the backing layer 220.

[0186] The backing layer 220 may be airtight but permeable to water vapor and may extend across the width of the wound dressing 155. For example, a backing layer 220 of a polyurethane membrane (e.g., Elastollan SP9109) with a pressure-sensitive adhesive on one side is gas-impermeable and thus serves to cover the wound and seal the wound cavity over which the wound dressing is placed. In this way, an effective chamber is created between the backing layer 220 and the wound site, within which negative pressure can be formed. For example, the backing layer 220 may be sealed to the wound contact layer 222 in the boundary region surrounding the circumference of the dressing using adhesive or welding techniques, ensuring that no air is drawn in through the boundary region. The backing layer 220 protects the wound from external bacterial contamination (bacterial barrier) and allows fluid from wound exudate to pass through this layer and evaporate from the outer surface of the membrane. The backing layer 220 may comprise two layers: a polyurethane membrane and an adhesive pattern coated on the membrane. Polyurethane membranes are permeable to moisture and can be made of materials that have increased water permeability when wetted. In some embodiments, the moisture permeability of the backing layer increases as the backing layer becomes wet. The water vapor permeability of a wet backing layer can be up to about ten times greater than that of a dry backing layer.

[0187] The area of ​​the absorbent layer 221 can be larger than the area of ​​the delivery layer 226, such that the edges of the absorbent layer and the delivery layer 226 overlap, thereby ensuring that the delivery layer does not contact the backing layer 220. This provides an external channel for the absorbent layer 221, which directly contacts the wound contact layer 222, facilitating faster absorption of exudate into the absorbent layer. Furthermore, this channel ensures that no fluid can accumulate around the periphery of the wound cavity, which could otherwise permeate through the seal around the dressing, leading to leakage. Figure 2B As shown, the absorbent layer 221 may be defined to be smaller than the periphery of the backing layer 220, such that the boundary or boundary region is defined between the edge of the absorbent layer 221 and the edge of the backing layer 220.

[0188] like Figure 2BAs shown, one embodiment of the wound dressing 155 includes an aperture 228 in the absorbent layer 221 located below the fluid connector 160. In use, for example when negative pressure is applied to the dressing 155, the wound-facing portion of the fluid connector can thus contact the delivery layer 226, which therefore facilitates the delivery of negative pressure to the wound site even when the absorbent layer 221 is filled with wound fluid. Some embodiments allow the backing layer 220 to adhere at least partially to the delivery layer 226. In some embodiments, the aperture 228 is at least 1-2 mm larger than the diameter of the wound-facing portion of the fluid connector 11 or the aperture 227.

[0189] For example, in embodiments with a single fluid connector 160 and through-hole, it may be preferable that the fluid connector 160 and through-hole are located in an off-center position. Such a position allows the dressing 155 to be positioned on the patient such that the fluid connector 160 is elevated relative to the rest of the dressing 155. With this positioning, the fluid connector 160 and filter 214 are less likely to come into contact with wound fluid that could prematurely occlude the filter 214, thereby impairing the delivery of negative pressure to the wound site.

[0190] Turning now to the fluid connector 160, some embodiments include a sealing surface 216, a bridging member 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 top surface of a wound dressing. In some embodiments, the bottom layer of the fluid connector 160 may include the sealing surface 216. The fluid connector 160 may also include an upper surface vertically spaced from the sealing surface 216, which in some embodiments is defined by a separate upper layer of the fluid connector. In other embodiments, the upper and lower surfaces may be formed of the same material. In some embodiments, the sealing surface 216 may include at least one orifice 229 therein for communication with the wound dressing. In some embodiments, the filter 214 may be positioned through the opening 229 in the sealing surface and may span 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 an adhesive or solder. In some embodiments, the sealing surface 216 may be positioned over pores in the cover layer, wherein an optional spacer element 215 is configured to create a gap between the filter 214 and the transport layer 226. In other embodiments, the sealing surface 216 may be positioned over pores in the cover layer and orifices in the absorbent layer 220 to allow the fluid connector 160 to provide airflow through the transport layer 226. In some embodiments, the bridging element 211 may include a first fluid passage 212 in communication with a negative pressure source, the first fluid passage 212 comprising a porous material, such as a 3D knitted material, which may be the same as or different from the porous layer 226 described above. The bridging element 211 may be encapsulated by at least one flexible membrane layer 208, 210 having a proximal end and a distal end, and configured to surround the first fluid passage 212, the distal end of the flexible membrane being connected to the sealing surface 216. The filter 214 is configured to substantially prevent wound exudate from entering the bridging element, and the spacer element 215 is configured to prevent the fluid connector from contacting the transport layer 226. These elements will be described in more detail below.

[0191] Some embodiments may also include an optional second fluid passage positioned above the first fluid passage 212. For example, some embodiments may provide an air leak that can be located proximal to the top layer, the top layer being configured to provide an air path into the first fluid passage 212 and the dressing 155, similar to the suction adapter described in U.S. Patent No. 8,801,685, which is incorporated herein by reference in its entirety.

[0192] In some embodiments, the fluid passage 212 is made of a compliant material that is flexible and allows fluid to pass through it if the spacer is twisted or folded. Suitable materials for the fluid passage 212 include, but are not limited to, foams, including open foams such as polyethylene or polyurethane foams, meshes, 3D knitted fabrics, nonwoven materials, and fluid channels. In some embodiments, the fluid passage 212 may be made of materials similar to those described above with respect to transport layer 226. Advantageously, such materials used in the fluid passage 212 not only allow for greater patient comfort but also provide greater resistance to kinking, enabling the fluid passage 212 to still transport fluid from the wound to the negative pressure source when twisted or bent.

[0193] In some embodiments, the fluid passage 212 may be constructed of wicking fabric, such as knitted or woven spacer fabric (e.g., knitted polyester 3D fabric, Baltex 7970®, or Gehring 879®) or nonwoven fabric. These materials may be adapted to guide wound exudate away from the wound through the passage and to deliver negative pressure or venting air to the wound site, and may also impart a degree of resistance to kinking or occlusion to the fluid passage 212. In some embodiments, the wicking fabric may have a three-dimensional structure, which in some cases may facilitate wicking fluid or delivering negative pressure. In some embodiments including wicking fabric, these materials remain open and are capable of delivering negative pressure to the wound area at typical pressures used in negative pressure therapy (e.g., 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 used to prevent the fluid passage 212 from collapsing under the application of negative pressure. In other embodiments, the wicking fabric used in the fluid passage 212 may be between 1.5 mm and 6 mm thick; more preferably, the wicking fabric may be 3 mm to 6 mm thick and may include one or more separate layers of wicking fabric. In other embodiments, the fluid passage 212 may be 1.2-3 mm thick, and preferably thicker than 1.5 mm. Some embodiments (e.g., suction adapters for dressings used to retain liquids such as wound exudate) may use a hydrophobic layer in the fluid passage 212, and only gas may travel through the fluid passage 212. Furthermore, and as previously mentioned, the materials used in the system may be conformal and soft, which can help avoid pressure sores and other complications that may be caused by the wound treatment system pressing on the patient's skin.

[0194] In some embodiments, filter element 214 is impermeable to liquids but permeable to gases, and serves as a liquid barrier, ensuring that no liquid can escape from wound dressing 155. Filter element 214 may also function as a bacterial barrier. Typically, the pore size is 0.2 μm. Suitable filter materials for filter element 214 include 0.2 μm Gore™ expanded PTFE, PALL Versapore™ 200R, and Donaldson™ TX6628 from the MMT series. Larger pore sizes may also be used, but these may require a secondary filtration layer to ensure complete bioload containment. Because wound fluid contains liquids, it is preferred, but not necessary, to use an oleophobic filter membrane, such as 1.0 μm MMT-332, prior to the 0.2 μm MMT-323. This prevents lipid clogging of the hydrophobic filter. The filter element may be attached to or sealed to a cover membrane on the port or pores. For example, the filter element 214 may be molded in the fluid connector 160, or may be adhered to one or both of the top of the cover layer and the bottom of the suction adapter 160 using an adhesive (such as, but not limited to, a UV-curable adhesive).

[0195] It should be understood that other types of materials may be used for filter element 214. More generally, microporous membranes, which are thin, flat sheets of polymeric materials containing billions of micropores, may be used. Depending on the membrane chosen, these pores can range in size from 0.01 to greater than 10 micrometers. Microporous membranes are available in both hydrophilic (water-filtering) and hydrophobic (water-repellent) forms. In some embodiments, filter element 214 includes a support layer and an acrylic copolymer membrane sheet formed on the support layer. In some embodiments, wound dressing 155 according to certain embodiments uses a microporous hydrophobic membrane (MHM). Many polymers can be used to form MHMs. For example, MHMs may be formed from one or more of PTFE, polypropylene, PVDF, and acrylic copolymers. All of these optional polymers can be treated to obtain specific surface characteristics that can be hydrophobic and oleophobic. Thus, these will repel liquids with low surface tension, such as multivitamin infusions, lipids, surfactants, oils, and organic solvents.

[0196] Membrane-mounted air filters (MHMs) block liquids while allowing air to flow through them. They also function as highly efficient air filters, eliminating potentially infectious aerosols or particles. Individual MHMs are well-known as an alternative to mechanical valves or vents. Therefore, configuring MHMs reduces product assembly costs, improving patient profitability and cost-effectiveness.

[0197] Filter element 214 may also include odor-absorbing materials, such as activated carbon, carbon fiber cloth, or VitecCarbotec-RT Q2003073 foam. For example, the odor-absorbing material may form a layer of filter element 214 or may be sandwiched between microporous hydrophobic membranes of the filter element. Filter element 214 thus allows gas to escape through the pores. However, the dressing may contain liquids, particles, and pathogens.

[0198] The wound dressing 155 may include a spacer element 215 that engages with the fluid connector 160 and the filter 214. By adding this spacer element 215, the fluid connector 160 and the filter 214 are supported without direct contact with the absorbent layer 220 or the delivery layer 226. The absorbent layer 220 may also serve as an additional spacer element to keep the filter 214 from contacting the delivery layer 226. Therefore, with this configuration, contact between the filter 214 and the delivery layer 226 and the wound fluid is minimized during use.

[0199] Similar to the embodiments of wound dressings described above, some wound dressings include a perforated wound contact layer having a silicone adhesive on the wound or skin contact surface and / or an acrylic adhesive on the back side. The wound contact layer can be perforated to match any pattern suitable for a particular wound. A transport layer or 3D spacer fabric pad is located above this boundary layer. An absorbent layer is located above the transport layer. The absorbent layer may include a superabsorbent nonwoven (NW) pad. The absorbent layer may extend approximately 5 mm beyond the transport layer at its periphery. The absorbent layer may have an opening or through-hole facing one end. The opening may be approximately 10 mm in diameter. A backing layer is located on the transport and absorbent layers. The backing layer may be a high water vapor transmission rate (MVTR) membrane patterned with acrylic adhesive. The high MVTR membrane and the wound contact layer encapsulate the transport and absorbent layers, creating a peripheral boundary of approximately 20 mm. The backing layer may have a 10 mm opening, which covers the opening in the absorbent layer. A fluid connector can be attached to the top of the opening, and the fluid connector includes a semi-permeable membrane (SPM) that is impermeable to liquids but permeable to gases and covers the aforementioned opening.

[0200] Wound dressing with sensor As described herein, wound dressings incorporating multiple sensors can be used to monitor wound characteristics as the wound heals. Data collected from both well-healed and unhealed wounds can provide useful insights into the measured object to indicate whether the wound is on a healing or non-healing trajectory. Any of the disclosed wound dressings, such as wound dressing 22, may include one or more of the following features or any other features disclosed herein.

[0201] In some implementations, various sensor technologies can be used in wound dressings or in one or more components that form part of the overall wound dressing device. For example, such as Figure 3 and Figure 4D As shown, they describe wound dressings 250, 320 with sensor arrays according to some embodiments, wherein one or more sensors may be incorporated into or within a wound contact layer, which may be a perforated wound contact layer, such as... Figure 4D As shown. In some embodiments, as Figure 3 As shown in the diagram, the wound dressing 250 may include a temperature sensor 252, a conductivity sensor 254, an optical sensor 256, and / or a SpO2 sensor 258. Figure 3 and Figure 4D The wound contact layer is shown as having a square shape, but it should be understood that the wound contact layer can have other shapes, such as rectangular, circular, oval, etc. In some embodiments, the sensor-integrated wound contact layer can be provided as a separate material layer, placed over the wound area and then covered by a wound dressing device or a component of a wound dressing device, such as gauze, foam or other wound dressing material, superabsorbent layer, drape, fully integrated dressing, such as Pico or Allevyn Life dressings, etc. In other embodiments, the sensor-integrated wound contact layer can be part of a single unit dressing, such as those described herein.

[0202] The sensor-integrated wound contact layer can be positioned to contact the wound and will allow fluid to pass through the contact layer while causing minimal or no damage to the tissue in the wound. The sensor-integrated wound contact layer can be made of a flexible material such as silicone and can contain antimicrobial agents or other therapeutic agents known in the art. In some embodiments, the sensor-integrated wound contact layer may contain an adhesive that adheres to wet or dry tissue. In some embodiments, the sensor or sensor array may be included in or encapsulated within other components of the wound dressing (e.g., the absorbent layer or spacer layer described above).

[0203] like Figure 3 and Figure 4D As shown, five sensors can be used, including sensors for example, those used for: temperature (e.g., 25 thermistor sensors in a 5×5 array, ~20 mm spacing), oxygen saturation or SpO2 (e.g., 4 or 5 SpO2 sensors in a single line from the center of the wound contact layer to its edge, 10 mm spacing), tissue color (e.g., 10 optical sensors in a 2×5 array, ~20 mm spacing; 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 the tissue color), and conductivity (e.g., 9 conductive contacts in a 3×3 array, ~40 mm spacing). Figure 4AAs shown, SpO2 sensors can be arranged in a single column from the center or near the center of the wound contact layer to the edge of the wound contact layer. The SpO2 sensor column allows the sensors to take measurements in the middle of the wound, at the edge or within the wound, or on intact skin to measure changes between areas. In some embodiments, the wound contact layer or sensor array can be larger than the size of the wound to cover the entire surface area of ​​the wound and the surrounding intact skin. The larger size of the wound contact layer and / or the sensor array and multiple sensors can provide more information about the wound area than if the sensors were placed only in the center of the wound or only in one area at a time.

[0204] The sensor can be attached to a flexible circuit board formed of a flexible polymer, including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), together with various fluoropolymers (FEP) and copolymers, or any material known in the art. The sensor array can be contained within two layers of flexible circuitry. In some embodiments, the circuit board can be a multilayer flexible printed circuit. In some embodiments, these flexible circuits can be attached to any layer of a wound dressing. In some embodiments, the flexible circuitry can be attached to a wound contact layer. For example, the flexible circuitry can be attached to a layer similar to a reference... Figure 2B The wound contact layer is described in the context of a wound contact layer. The wound contact layer may have incisions or slits that allow one or more sensors to protrude from the lower surface of the wound contact layer and directly contact the wound area.

[0205] In some embodiments, the sensor-integrated wound contact layer may include first and second wound contact layers, wherein a flexible circuit board is sandwiched between the two wound contact layer materials. The first wound contact layer has a lower surface intended to contact a 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 a wound dressing or one or more components forming part of an overall wound dressing device. The upper surface of the first wound contact layer and the lower surface of the second wound contact layer may be adhered together by the flexible circuit board sandwiched between the two layers.

[0206] In some embodiments, one or more sensors on the flexible circuit board may be completely encapsulated or covered by a wound contact layer to prevent contact with moisture or fluids in the wound. In some embodiments, the first wound contact layer may have an incision or slit that allows one or more sensors to protrude from the lower surface and directly contact the wound area. For example, as... Figure 4DOne or more SpO2 sensors shown are depicted as protruding from the bottom surface of the wound contact layer. In some embodiments, the SpO2 sensor may be mounted directly on the lower surface of the first wound contact layer. Some or all of the sensors and electrical or electronic components may be canned or encapsulated (e.g., presenting a waterproof or liquid-resistant nature) with a polymer (e.g., silicone or epoxy-based polymer). Polymer encapsulation can prevent fluid ingress and leaching of chemicals from the components. In some embodiments, the wound contact layer material may seal the components to prevent water ingress and leaching of chemicals.

[0207] In some embodiments, the collection and processing of wound-related information may use three components: a sensor array, a control or processing module, and software. These components are described in more detail herein.

[0208] Figure 4A A flexible sensor array circuit board 300, according to some embodiments, is shown, including a sensor array portion 301, a tail portion 302, and a connector pad end portion 303. The sensor array portion 301 may include sensors and associated circuitry. The sensor array circuit board 300 may include an elongated tail portion 302 extending from the sensor array portion 301. The connector pad end portion 303 is connectable to a control module or other processing unit to receive data from the sensor array circuitry. The elongated tail portion 302 may allow the control module to be placed away from the wound, for example, in a more convenient location away from the wound.

[0209] Figure 4B An embodiment of a flexible circuit board with four different sensor array geometries 301A, 301B, 301C, and 301D is illustrated. The illustrated embodiment includes tail portions 302A, 302B, 302C, and 302D. In some embodiments, the flexible circuit board includes a short portion or excludes the tail portion. In some embodiments, the four different sensor array geometries shown can be implemented in a flexible circuit. Although Figure 4B Four different sensor array formats and configurations are shown. Designs 301B and 302B also include connector pad ends 303 configured to provide an electrical or electronic connection between the initiating array 301B and the control module. One or more of designs 301A, 301C, or 301D may also include connector pad ends, such as portion 303, to allow the flexible circuit board 301A, 301C, or 301D to communicate with the control module or other processing units. In some embodiments, the sensor array communicates wirelessly with the control module, and the tail portion may be omitted.

[0210] Figure 4C Showing more details Figure 4B The sensor array design includes the sensor array section 301B. Figure 3 or Figures 4A-4DIn any one or more of the embodiments, the sensor array portion may include multiple portions extending around the periphery of the wound dressing component (e.g., a wound contact layer) or extending inward from the outer edge of the wound dressing component. For example, the illustrated embodiment includes multiple linear extensions that may be parallel to the edge of the wound dressing component and, in some embodiments, follow the entire periphery of the wound dressing component. In some embodiments, the sensor array portion may include a first plurality of parallel linear extensions perpendicular to a second plurality of parallel linear extensions. These linear extensions may also have different lengths and may extend inward to different locations within the wound dressing component. The sensor array portion preferably does not cover the entire wound dressing component, thereby creating gaps between the portions of the sensor array. Figure 3 As shown, this allows some, and possibly most, wound dressing components to remain uncovered by the sensor array. For example, for wound dressing components such as... Figure 3 and Figure 4D The perforated wound contact layer shown may have a sensor array portion 301 that does not obstruct most of the 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, thereby minimizing obstruction of fluid flow by the perforations.

[0211] Figure 4D A flexible sensor array incorporated into a perforated wound contact layer 320 according to some embodiments is illustrated. As shown, the sensor array may be sandwiched between two membranes or wound contact layers. The wound contact layer may have perforations formed as slits or holes as described herein, small enough to help prevent tissue growth into the wound dressing while allowing wound exudate to flow into the dressing. In some embodiments, the wound contact layer may have one or more slits, which increase the flexibility of the wound contact layer with the integrated sensor array. In some embodiments, one of the wound contact layers may have additional incisions to accommodate sensors so that they can directly contact the skin.

[0212] The connection of the sensor array can vary depending on the various sensors and sensor array designs used. In some embodiments, for example, such as Figure 4B As shown, a total of 79 connections can be used to connect components of the sensor array. The sensor array can terminate in two parallel 40-way 0.5 mm pitch flat flexible cable (FFC) contact surfaces, with terminals on the top surface designed to connect to FFC connectors such as Molex 54104-4031.

[0213] In some embodiments, one or more sensors (such as thermistors, conductivity sensors, SpO2 sensors, color sensors, etc.) may be used on a sensor array to provide information related to the wound and / or the condition surrounding the wound. Any of the sensor arrays and / or individual sensors disclosed herein can help clinicians monitor the condition of a wound, which may include wound healing or non-healing (e.g., stable, deteriorating, etc.). One or more sensors may operate individually or in coordination with each other to provide data related to the wound and wound healing characteristics.

[0214] Temperature sensors can use thermocouples or thermistors to measure temperature. Thermistors can be used to measure or track the temperature of the thermal environment beneath the wound or within the wound dressing. Temperature sensors can be calibrated, and the data obtained from the sensors can be processed to provide information about the wound environment. In some embodiments, environmental sensors that measure ambient air temperature can also be used to help eliminate problems associated with ambient temperature deviations.

[0215] Optical sensors can be used to measure wound appearance using an RGB sensor with an illumination source. In some embodiments, both the RGB sensor and the illumination source are pressed against the skin, allowing light to penetrate the tissue and reveal the spectral characteristics of the tissue itself.

[0216] Light propagation in tissues is governed by two main phenomena: scattering and attenuation. Regarding attenuation, as light passes through tissue, its intensity may be lost 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.

[0217] The scattering process can be more complex and may involve various "regimes" that must be considered. The first aspect of scattering is based on the comparison between the size of the scattering center and the wavelength of the incident light. If the scattering center is much smaller than the wavelength of the light, Rayleigh scattering can be assumed. If the scattering center is around the wavelength of the light, a more detailed Mie scattering formula 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 the light (the distance between scattering events) is much greater than the distance traveled, ballistic photon propagation is assumed. In the case of tissue, scattering events are approximately 100 micrometers apart, so a path distance of 1 mm will effectively randomize the photon direction, and the system will enter a diffuse region.

[0218] Ultra-bright light-emitting diodes (LEDs), RGB sensors, and polyester light filters can be used as components of an optical sensor for measurements through tissue color differentiation. For example, since surface color can be measured from reflected light, color can be measured from light that first passes through the tissue for a given geometry. This can include color sensing of diffused light from an LED in contact with the skin. In some embodiments, the LED can be used in conjunction with a nearby RGB sensor to detect light that has been diffused through the tissue. The optical sensor can be imaged using diffused internal light or surface-reflected light.

[0219] Additionally, optical sensors can be used to measure autofluorescence. Autofluorescence works because tissue absorbs light of one wavelength while emitting light of another. Furthermore, dead tissue may not fluoresce, and therefore this can be a very strong indicator of tissue health. Due to the short penetration depth of blue light (or even UV light), such as UV light with a red-sensitive photodiode (or some other wavelength-shifting band) nearby, it could be very useful as a binary test for healthy tissue, which will fluoresce at very specific wavelengths.

[0220] Conductivity sensors can be used to determine the difference between living and dead tissue, or to display impedance changes caused by opening a wound in pathological tissue. A conductivity sensor may include an Ag / AgCl electrode and an impedance analyzer. The conductivity sensor can be used to measure impedance changes in a wound growth region by measuring the impedance of the surrounding tissue / region. In some embodiments, a sensor array may utilize the conductivity sensor to measure changes in conductivity on peripheral electrodes due to changes in wound size or shape. In some embodiments, the conductivity sensor may be used in or around the wound bed.

[0221] In some embodiments, the pH-changing pad can be used as a pH sensor. A spectrometer and a broadband white light source can be used to measure the spectral response of the pH dye. Illumination and imaging can be provided on the surface of the wound dressing in contact with the wound and on the same side as the fluid application (bottom surface). Alternatively, in some embodiments, the illumination and imaging source can be located 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.

[0222] In some embodiments, a pulse oximetry SpO2 sensor can be used. Pulsating blood flow can be observed to measure the degree of blood oxidation. Pulsating oximetry works by performing time-resolved measurements of light absorption / transmission in tissue at two different wavelengths. When hemoglobin is oxygenated, its absorption spectrum changes relative to unoxygenated blood. By measuring at two different wavelengths, a ratiometric measure of the degree of blood oxygenation can be obtained.

[0223] Components in the sensor array can be connected via multiple connections. In some embodiments, thermistors can be arranged in groups of five. Each thermistor has a nominal value of 10 kΩ, and every group of five shares a common ground. There are five groups of thermistors, providing a total of 30 connections. In some embodiments, there can be nine conductive terminals. Each conductive terminal requires one connection, providing a total of nine connections. In some embodiments, there can be five SpO2 sensors. Each SpO2 sensor requires three connections, plus power and ground (which are independently covered), providing a total of 15 connections. In some embodiments, there can be 10 color sensors. Each color sensor includes an RGB LED and an RGB photodiode. Each color sensor requires six connections, but five of these are common to all sensors, providing a total of 15 connections. Power and ground are considered separately. In some embodiments, there can be five pH sensors. The pH sensor can be a color change disk and can be sensed using the aforementioned color sensors. Therefore, the pH sensor does not require additional connections. There can be three power rails and seven ground return signals, providing a total of 10 common connections. In some embodiments, the sensor array may include 25 thermistors (Murata NCP15WB473E03RC), 9 conductive terminals, 5 SpO2 (ADPD144RI), 10 RGB LEDs (e.g., KPTF-1616RGBC-13), 10 RGB color sensors, 10 FETs, a printed circuit board (PCB), and components.

[0224] As described herein, the control module can be used to interface with a sensor array. The controller 24 may include one or more of the following features. In some embodiments, the control module may include a power source, such as a battery, and electronics for driving the sensors. The control module may also record data at appropriate intervals and allow data transfer to an external computing device, such as... Figure 1A The personal computer (PC) shown is illustrated. The control module can be customized to have various characteristics based on the sensors used in the sensor array and the data collected by the sensors. In some embodiments, the control module can be comfortable enough and small enough to be worn continuously for several weeks. In some embodiments, the control module can be positioned near or on the wound dressing. In some embodiments, the control module can be positioned at a remote location away from the wound dressing and the accompanying sensor array. The control module can communicate with the sensor array and the wound dressing via wires or wireless communication, whether located on, near, or away from the wound dressing. In some embodiments, the control module can be adapted for use with different sensor arrays, and the sensor array can be easily replaced.

[0225] In some embodiments, the control module may include a combination of various requirements and features, including but not limited to those listed in Table 1 below.

[0226] Table 1. Optional features of the control module Figure 4E A block diagram 330 of a control module according to some embodiments is illustrated. The controller 24 may include one or more of the illustrated and described features. The block diagram of the control module includes a conductivity driver block 391 showing features of a conductivity driver. Block 392 shows features of a thermistor interface, and block 393 shows features of an optical interface. The control module may include a controller or microprocessor having features similar to those shown in block 394. A real-time clock (RTC), status LEDs, a USB connector, serial flash memory, and a debug connector may be included as features of the control module, such as... Figure 4E As shown in the image.

[0227] In some embodiments, the microprocessor may have one or more of the following features: a 2.4 GHz radio (integrated or external) or another suitable frequency with one or more suitable antennas; a provided Bluetooth software stack; an SPI interface; USB (or UART for an external USB driver); I2C; a 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 stacking limitations. The Bluetooth stack typically requires ~20 kB of onboard flash memory, so at least 32 kB will be required. In some embodiments, 64 kB may be required if complex data processing is considered. The processor core may be an ARM Cortex M4 or a similar processor core. In some embodiments, components may include ST's STM32L433LC or STM32F302R8, which may require an external radio, or NXP's Kinetis KW series, which includes an integrated radio.

[0228] In some embodiments, the control module may include a memory component, wherein the amount of local storage depends on the sensor’s sampling rate and resolution. For example, serial flash memory devices from many manufacturers (Micron, Spansion) can meet an estimated data requirement of 256 Mb (32 MB).

[0229] The control module can use one or more analog switches. In some embodiments, analog switches with good on-resistance and reasonable bandwidth can be used. For example, Analog Devices' ADG72 or NXP's NX3L4051HR can be used. Based on the initial system architecture, eight of these will be required.

[0230] The control module may include a power source, such as a battery. For example, a 300mWh / day battery can be used. For 7 days, this is 2100mWh. This can be provided by: a 10-day, non-rechargeable ER14250 (14.5mm diameter × 25mm) LiSOCl2 battery; or a 7-day, rechargeable Li 14500 (14.5mm diameter × 500mm) lithium-ion battery.

[0231] The control module may include 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, charge controllers, and other power supplies.

[0232] The PCB for the control module can be a 4-layer board, approximately 50mm × 20mm, or 25mm × 40mm. The type of PCB used largely depends on the connection requirements of the sensor array.

[0233] The control module housing can be a two-part molded part with clip features to allow easy access for replacing the sensor array or battery.

[0234] Data acquired by the sensor array can be transmitted via the control module and processed by the host software. The software can be located on a computing or processing device (see...). Figure 1A The software is executed on the control module. The processing device can be a PC, tablet, smartphone, or other computer capable of running the host software. The processing device executing the software can communicate with the control module via a wire or wireless communication. In some embodiments, the software can be configured to provide access to data stored on the control module, but not to perform big data analytics. The host software may include an interface to the control module via Bluetooth or USB. In some embodiments, the host software can read the status of the control module, download recorded data from the control module, upload sampling rate control to the control module, convert data from the control module into a format suitable for processing by the big data analytics engine, or upload data to the cloud (see [link to cloud services]). Figure 1A So that it can be processed by the analysis engine.

[0235] The software can be developed for PCs (Windows / Linux), tablets, or smartphones (Android / iOS) or multiple platforms.

[0236] Further embodiments of wound dressings having sensors and other related systems are disclosed in international application PCT / IB2017 / 000693, filed on May 12, 2017, entitled “SENSOR ENABLED WOUND MONITORING ANDTHERAPY APPARATUS”, the disclosure of which is incorporated herein by reference in its entirety.

[0237] In some embodiments, the negative pressure source (e.g., a pump) and some or all other components of the local negative pressure system, such as power supplies, sensors, connectors, user interface components (e.g., buttons, switches, speakers, screens, etc.), may be integrated with the wound dressing. In some embodiments, the components may be integrated below, inside, on top of, or near the backing layer. In some embodiments, the wound dressing may include a second overlay or a second filter layer positioned above the layers of the wound dressing and any integrated components. The second overlay may be the uppermost layer of the dressing or a separate wrapping layer enclosing the integrated components of the local negative pressure system.

[0238] As used in this article, the upper layer, top layer, or above layer refers to the layer furthest from the surface of the skin or wound when the dressing is in use and positioned above the wound. Therefore, the lower surface, lower layer, bottom layer, or below layer refers to the layer closest to the surface of the skin or wound when the dressing is in use and positioned above the wound.

[0239] Component positioning in wound dressings for implementing sensors In some embodiments, electrical or electronic components (e.g., sensors, connections, etc.) may be placed or positioned on or embedded in one or more wound dressing components, which may be placed on or on a wound, skin, or both. For example, one or more electronic components may be positioned on the substrate side facing the wound. Figure 2BThe lower surface 224 of the wound contact layer 222. The substrate may be flexible, elastic, or stretchable, or substantially flexible, elastic, or stretchable to conform to or cover the wound. For example, the wound contact layer may be made of stretchable or substantially stretchable materials, such as one or more of the following: polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polystyrene tetramer (PET), polybutylene phthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), together with various fluoropolymers (FEP) and copolymers, or other suitable materials. In some cases, one or more electronic components may be alternatively or additionally placed or positioned on, or embedded in, any one or more of the transport layer, absorbent layer, backing layer, or any other suitable layer of the wound dressing.

[0240] In some implementations, while it may be desirable for the wound contact layer to be stretchable to better conform to or cover the wound, at least some electronic components may not be stretchable or flexible. In such cases, when the wound is bandaged with a wound dressing and the wound contact layer is in or over the wound, undesirable or excessive localized strain or stress may be applied to one or more electronic components, such as to the support area or mounting of the electronic components. For example, such stress may be caused by patient movement, changes in wound shape or size (e.g., due to healing), etc. Such stress may cause movement, displacement, or malfunction of one or more electronic components (e.g., disconnection from a pin or another connector, creating an open circuit). Alternatively or additionally, it may be necessary to maintain the position of one or more electronic components (e.g., one or more sensors) on the wound contact layer in the same or substantially the same location or area relative to the wound (e.g., in contact with the wound) such 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. Although the surface of the stretchable wound contact layer may move when, for example, the patient moves, it may be desirable for one or more electronic components to be in the same location or area relative to the wound.

[0241] In some embodiments, one or more rigid, stiff, or non-stretchable or substantially rigid, stiff, or non-stretchable regions, such as one or more non-stretchable or substantially non-stretchable material regions, may be mounted, positioned, or placed on a wound contact layer (or another suitable wound dressing component) to support one or more electronic components. Mounting, positioning, or placing one or more electronic components in one or more non-stretchable or substantially non-stretchable regions can prevent the formation of localized stresses or help maintain the position of one or more electronic components relative to the wound. In some cases, one or more electronic components may alternatively or additionally be flexible, for example, mounted or 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.

[0242] Component arrangement in wound dressings for implementing sensors For example, various layouts or arrangements of wound dressings for implementing sensors are considered, such as Figure 5A-5J As shown and described elsewhere in this disclosure. Figure 5A-5J Any wound dressing shown may be disposable. The component arrangements described below (or in other parts of this disclosure) are not limited to positioning on a wound dressing. In some embodiments, the components may be arranged on another dressing, structure, or substrate, or may be provided separately to be positioned over any wound, as broadly defined herein. The component arrangements may be used to prevent or treat one or more wounds.

[0243] Figure 5A The illustration shows a wound dressing implementing a sensor according to some embodiments, which includes a power source 501, such as a battery, positioned in or on the dressing. In this and other embodiments described herein, contour 510 represents the contour of the wound. Figure 5B The illustration shows a wound dressing implementing a sensor according to some embodiments, which includes a power source and a charger configured to recharge the power source, such as coil 503. For example, power can be wirelessly or transmitted via wires to the charger to recharge power source 501. Power can be transmitted wirelessly, for example, through inductive coupling, capacitive coupling, magnetic dynamic coupling, far-field transmission, etc. As another example, energy harvesting can be additionally or alternatively used to recharge power source 501. Figure 5B The power supply 501 and charger are positioned on or within the dressing. In some embodiments, the illustrated coil 503 may act as an antenna for wirelessly transmitting and / or receiving data.

[0244] Figure 5CThe illustration depicts a wound dressing with an implemented sensor, configured to connect to a reusable controller (e.g., controller 24) according to some embodiments. The controller includes a power source 501, such as a battery. The power source 501 may be rechargeable. Figure 5D The illustration shows a reusable wound dressing that implements a sensor according to some embodiments. The wound dressing is configured to be connected to a power source 501, such as a battery, located externally to the dressing. The power source 501 shown may be rechargeable or replaceable.

[0245] Figure 5E A wound dressing implementing sensors according to some embodiments is illustrated, including one or more sensors 512E or 514E positioned on or within the dressing. A controller 502E separate from the wound dressing according to some embodiments is also illustrated. The controller 502E can be configured to wirelessly transmit power (e.g., from the illustrated power source 501) to one or more sensors 512E or 514E using any of the techniques described herein. For example, one or more sensors 512E or 514E may each include a coil 503 for inductive coupling. One or more sensors 512E or 514E may not include a power source 501. In some embodiments, one or more of the illustrated coils may act as antennas for wirelessly transmitting and / or receiving data. In some embodiments, the controller 502E may be positioned within or on the wound dressing.

[0246] Figure 5F The illustration depicts a wound dressing implementing sensors according to some embodiments, comprising one or more sensors 512F or 514F positioned on or within the dressing, and a controller 502F. Figure 5E Depending on the arrangement, one or more sensors 512F or 514F include a power supply 501, which can be recharged via wireless power transmission from controller 502F as described herein. As shown, controller 502F is detached from the wound dressing. In some embodiments, one or more of the illustrated coils 503 may act as antennas for wirelessly transmitting and / or receiving data. In some embodiments, controller 502F may be positioned within or on the wound dressing.

[0247] Figure 5G The illustration shows a wound dressing implementing sensors according to some embodiments, comprising one or more sensors 512G or 514G and a controller 502G positioned on or within the dressing. Figure 5E-5FDepending on the arrangement, one or more sensors 512G or 514G are connected to the controller 502G via one or more wires. The controller 502G may include a power supply 501, which may be rechargeable or replaceable. In some cases, one or more sensors 512G or 514G may be flexible or stretchable. For example, one or more sensors 512G or 514G may be positioned on a flexible or stretchable substrate, such as TPU. In some cases, one or more sensors 512G or 514G may not be flexible or stretchable. For example, one or more sensors 512G or 514G may be positioned on a non-stretchable substrate, such as PET or polyimide. As shown, the controller 502G is separate from the wound dressing. In some embodiments, the controller 502G may be positioned within or on the wound dressing. In some embodiments, one or more antennas may be positioned within or on the wound dressing, or on the controller 502G, for wirelessly transmitting and / or receiving data.

[0248] Figure 5H The illustration depicts a wound dressing implementing sensors according to some embodiments, comprising one or more sensors 512H and a power source 501, both positioned on or within the dressing. The power source 501 may be a rechargeable or replaceable power source as described herein. The power source 501 provides power to one or more sensors 512H via one or more flexible or stretchable connections or tracks 532H. One or more connections 532H may additionally or alternatively transmit data between the one or more sensors 512H. The one or more connections 532H may be mounted or positioned on a stretchable material, such as PET or another stretchable material described herein. In some embodiments, one or more sensors 512H may be incorporated into components or tracks positioned on a non-stretchable substrate (as described herein). In some embodiments, the stretchable material may be positioned (e.g., coplanar) between the non-stretchable substrates of one or more sensors 512H. In some cases, the stretchable material may be positioned as a laminate or a partially or fully encapsulated layer.

[0249] Figure 5I The illustration depicts a wound dressing implementing a sensor according to some embodiments, configured for fluid connection to a negative pressure wound therapy device 542I. Device 542I is separate from the wound dressing and includes a power source 501 and a negative pressure source, such as a pump 505, configured to provide negative pressure to the wound. As described herein, power can be transferred from device 542I to the wound dressing. The electrical wiring and the negative pressure connection can be coaxial, have parallel axes, or the wiring can be helically wound around the negative pressure connection. The wiring can be manufactured during the extrusion of the negative pressure connection, which may include one or more channels for the transmission of gas and / or fluid. Figure 5JThe illustration shows a wound dressing in which the sensor is implemented, including a power source 501 and a negative pressure source in or on the dressing.

[0250] In some implementations... Figure 5A-5J Any embodiment shown can be combined with any one or more of the other illustrated embodiments. For example, Figure 5B The wound dressing for implementing the sensor shown can be used with Figure 5H The wound dressing assembly implementing the sensor is shown. This assembly will include a charger positioned on or within the dressing. As another example, Figure 5H The wound dressing for implementing the sensor shown can be used with Figure 5J The wound dressing assembly implementing the sensor is shown. This assembly will include a negative pressure source positioned in or on the dressing.

[0251] In some embodiments, a rechargeable energy source, such as one or more of a supercapacitor or an electric double-layer capacitor (EDLC), may be positioned in or on the dressing. The dressing may be stored without any power before deployment on the patient. The rechargeable energy source of the dressing may be charged before the dressing is positioned on the patient. This charging may be performed wirelessly. One or more indicators may be provided to indicate that the power source is charged. The power source may be charged using one or more energy harvesting technologies.

[0252] In some implementations, supercapacitors may be used alternatively or additionally for wireless communication. When powered by a pre-charged supercapacitor, the wireless communication circuitry can operate more efficiently, for example, in terms of range and efficiency for one or more of the transmission or reception. This may be due, for example, to the lower internal resistance of the supercapacitor, which allows it to supply high pulses of compressed current more efficiently than a battery.

[0253] Integrated wound dressing with sensor implementation In some embodiments, a wound dressing implementing a sensor may be configured to operate without a separate controller (e.g., controller 24 or any other controller described herein). Conversely, an integrated wound dressing may include one or more electronic components of a controller, such as a processor, antenna, power supply, etc., located within or on the wound dressing (e.g., on the wound contact layer). An integrated wound dressing may not include connectors, such as connector 28 or any other connector described herein. Some advantages of excluding a separate controller and connector may include: reduced risk of fluid entering the separate controller via the connector; reduced electromagnetic interference, noise, user connection errors, arcing (e.g., due to connection or trace separation to levels unattainable with small connectors), intrusion of foreign (e.g., conductive) objects or materials, or other situations that may be introduced via connectors, etc. One or more of these advantages can be achieved while minimizing the size or weight of the system and / or eliminating potentially inflexible connecting elements.

[0254] Although the arrangement of electronic components (including sensors and processors) is described in conjunction with positioning on a wound dressing, the arrangements described below (or in other parts of this disclosure) are not limited to positioning on a wound dressing. In some embodiments, components may be arranged on another dressing, structure, or substrate, or may be provided separately to be positioned over any wound, as broadly defined herein. Component arrangements can be used to prevent or treat one or more wounds.

[0255] Figure 6 An integrated wound dressing 600 implementing a sensor is illustrated according to some embodiments. The dressing includes a substrate 610, which may be substantially flexible as described herein. The substrate 610 supports one or more electronic modules or components 630 and one or more electronic connections 620 as described herein. The one or more electronic components may be sensors, processors, power supplies, etc. The one or more electronic components may be connected to one or more tracks via one or more connectors 640. The connectors 640 may be pins, leads, blocks, surface mount (SMT), etc. Additionally or alternatively, sockets may be used to support and electrically connect the electronic components.

[0256] Electronic connections or traces 620 may be traces printed on substrate 610, for example, using conductive copper, conductive ink (e.g., silver ink, silver / silver chloride ink, copper ink, graphite ink, carbon ink, dielectric ink, etc.). At least some of the electronic connections 620 may be flexible or stretchable, or substantially flexible or stretchable. Connector 640 may be configured to electrically connect electronic components 630 to electronic connections 620 (e.g., ...). Figure 6 As shown in the diagram, this electronic connection can also be connected to other electronic modules (not shown) located on the substrate 610, on or within other components of the wound dressing, or outside the wound dressing.

[0257] One or more of the substrate 610, electronic components, or electronic connections may be partially or completely encapsulated by a coating 650. The coating 650 may be a conformal coating configured to coat or encapsulate one or more of the substrate 610 or components supported by the substrate (e.g., electronic connection 620 or electronic component 630). The coating 650 may provide biocompatibility, shielding, or protection of the electronic device from fluid contact, etc. The coating 650 may be hydrophobic. As used herein, hydrophobicity may encompass substantially preventing the ingress of fluids, including water. The coating 650 may be one or more of the following: a suitable polymer; an adhesive, such as Dymax 1165 or 1072-M UV, light, or thermosetting or curable adhesive, Optimax adhesive (e.g., NovaChem Optimax8002-LV); parylene (such as parylene C); silicone; epoxy resin; urea; urethane acrylate; or another suitable biocompatible and stretchable material. As used herein, biocompatibility may mean compliance with one or more applicable standards, such as ISO 10993 or USP Class VI. Coating 650 may be thin, for example, about 100 micrometers thick, less than about 100 micrometers thick, or greater than about 100 micrometers thick. Coating 650 may be applied and cured using one or more of UV, light, or thermal curing methods. In some embodiments, coating 650 may be applied to the component on the opposite side of substrate 610 (or the side facing away from the wound), particularly if the substrate is fluid-impermeable. In some embodiments, coating 650 is optional.

[0258] The wound dressing 610 may also include one or more adhesive pads, tracks, or areas 660 applied to the wound-facing side of the substrate 610 or the wound-facing side of the coating 650. The adhesive material may be one or more of silicone (e.g., two-component silicone, one-component silicone), gel, epoxy, acrylic base material, or other suitable materials. The adhesive may be applied and cured using one or more of UV, light, or thermal curing methods. For example, the adhesive may be printed, sprayed, coated, etc., and then cured by UV, light, thermal curing, catalysis, steam, etc. In some embodiments, the adhesive is optional.

[0259] In some embodiments, even when the substrate 610 is under stress or strain, one or more adhesive regions 660 may be patterned to position or adhere specific components in a particular area, region, or location in contact with or relative to the wound. While the substrate may strain between the adhesive regions, electronic components 630 (such as sensors) will remain in the same position in contact with or relative to the wound (due to the adhesive regions), thus maintaining the most repeatable measurements. Additionally, because the body (e.g., skin, which may strain by approximately 20%) will release some stress (e.g., due to the wound contact layer being attached to the wound via one or more adhesive regions), and the substrate 610 will yield around the electronic module, not too much stress will be applied to the connector 640 of the electronic component 630. Similar stress relief may be provided to one or more electronic connections 620 that may be covered by one or more adhesive regions. Any or all of the one or more adhesive regions 660 may be positioned on the coating 650, between the coating 650 and the substrate 610, between one or more components 620 and the substrate 610 (e.g., to adhere one or more components to the substrate), or between one or more components 620 and the coating 650.

[0260] Additional details of the construction of wound dressings, including conformal coatings, adhesive zones, and non-stretchable zones, are described in the following documents: International Patent Application No. PCT / EP2018 / 059333, filed April 11, 2018, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLEDNEGATIVE PRESSURE WOUND THERAPY DRESSINGS,” which claims U.S. Provisional Patent Application No. 62 / 484316, filed April 11, 2017, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLEDNEGATIVE PRESSURE WOUND THERAPY DRESSINGS,” and U.S. Provisional Patent Application No. 62 / 484316, filed April 11, 2017, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLEDNEGATIVE PRESSURE WOUND THERAPY.” Priority claims to U.S. Provisional Patent Application No. 62 / 484321 entitled “DRESSINGS”, U.S. Provisional Patent Application No. 62 / 524564 entitled “COMPONENT POSITIONING AND STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS” filed June 25, 2017; and International Patent Application No. PCT / EP2018 / 069883 entitled “BIOCOMPATIBLE ENCAPSULATION AND COMPONENTSTRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS” filed July 23, 2018, which are incorporated herein by reference in their entirety.

[0261] One or more electronic components 630 may be configured to continue functioning properly even under pressure or strain that the substrate 610 may experience when the wound dressing 600 is positioned on the patient. For example, an electronic component, such as a processor (e.g., an application-specific integrated circuit (ASIC)), may include or be packaged on a “strip” or very thin silicon wafer adapted to be positioned on a wound contact layer to be placed on the patient’s wound. Using a thin processor to avoid causing discomfort or pain to the patient may be advantageous. When the wound contact layer is subjected to stress or strain, the thin wafer may bend, which could lead to wafer breakage or other malfunctions, causing the processor to fail to function correctly. Silicon can be elastic or robust under compression, but brittle or fragile under tension, such as when bent. For example, the bending radius of the thin silicon wafer may be about 5 mm or greater.

[0262] In some embodiments, one or more electronic components 630 may be at least partially formed of a reinforcing material. For example, by subjecting an electronic component (e.g., a wafer) to compression or placing it under compression, the tension zone of a bent wafer can be reduced; this may be referred to as pre-strain. In some embodiments, the wafer may be pre-strained, for example, by applying compression to the wafer before or after positioning it on the substrate 610. In the latter case, a portion of the entire substrate 610 may be compressed. The substrate may be slightly compressed before placing the wafer. The wafer may be compressed and subsequently relaxed. Compression may be applied mechanically. In some cases, the substrate may be stretched before placing the wafer. Stretching may be performed mechanically. After the wafer is placed on the substrate, the substrate may be relaxed, which may apply compression to the wafer.

[0263] In some embodiments, one or more of a conformal coating (e.g., coating 650) or an adhesive (e.g., adhesive 660) may apply compression to the wafer when applied to a substrate. For example, when cured using any of the processes described herein, the coating (or adhesive) material may shrink, thereby applying compression to the substrate or wafer.

[0264] In some cases, compression can be applied using a film. The film can be stretched and applied to a substrate or wafer. As described herein, the film can be applied to the substrate before the wafer is placed on it, to the wafer before the wafer is placed on it, or to the substrate and / or wafer after the wafer is placed on it. Shrink wrapping can result in compression of the substrate or wafer. Shrink wrapping films can be applied to a substrate or wafer, resulting in compression of the substrate or wafer. In some cases, the film can be shrunk by curing (instead of stretching or as a supplement to stretching).

[0265] When subjected to stress or strain, pre-strained wafers can exhibit improved elasticity. Using a reinforced concrete analogy, the wafer can resemble concrete, and one or more of the substrate, coating, or adhesive can resemble steel reinforced with concrete.

[0266] The foregoing description applies to any electronic component that can be positioned on substrate 610. For example, in some cases, at least some electronic components 630 may be positioned on a circuit board (e.g., a printed circuit board (PCB) or a printed circuit board assembly (PCBA)). The circuit board may include one or more connections between one or more electronic components located on the circuit board. The circuit board may be pre-stressed as described herein so that it continues to function properly even under stress or strain.

[0267] Alternatively or concurrently, in some embodiments, one or more electronic components 630 are included or encapsulated on a flexible or substantially flexible substrate. For example, such a substrate may be formed of one or more of PET, PEN, or polyimide.

[0268] In some implementations, the integrated wound dressing implementing the sensor includes one or more power sources configured to power one or more electronic components. As described herein in conjunction with the electronic components, reducing the thickness of one or more components of the one or more power sources for positioning on the wound contact layer (to be placed on the patient's wound) can be advantageous. For example, button or coin batteries, foil-sealed batteries, paper batteries, flexible lithium batteries, lithium ceramic batteries, lithium polymer batteries, etc., may have a significant thickness dedicated to the housing (in the case of coin batteries) or another structure that does not directly affect the storage capacity. For example, in the case of coin batteries, the battery capacity may decrease significantly as the housing thickness decreases. The battery capacity may decrease disproportionately and rapidly as the size of the battery housing decreases because the thickness of the housing occupies a large portion of the total volume and cannot be reduced proportionally to the other components of the battery. Similarly, in the case of paper batteries, a considerable portion of the thickness (e.g., 300 to 400 μm or more) may be dedicated to components that do not provide any storage capacity.

[0269] In some embodiments, the thickness of one or more power supplies can be reduced by directly positioning one or more power supply components (e.g., battery chemistry or chemicals) on a substrate (e.g., a substantially flexible wound contact layer) or one or more electronic connections. A separate housing or enclosure may not be required, which can reduce the thickness of one or more power supplies and allow for increased (or decreased) capacity by increasing (or decreasing) the size of the power supply components.

[0270] Figures 7A-7DThe illustration shows power integration in a wound dressing 700 implementing a sensor according to some embodiments. The wound dressing 700 includes a substrate 710 (which may include a wound contact layer as described herein), one or more electronic connections 715, and one or more electronic components 732 positioned on one or more connectors 740, such as in combination. Figure 6 As explained herein, a power supply (e.g., battery) component 720 may be positioned on an electronic connection 715. In some embodiments, component 720 may be a cathode electrode as described herein. For example, component 720 may be printed directly onto the electronic connection using any of the techniques described herein. The entire component 720 may be positioned on the electronic connection. For example, the dimensions of component 720 (e.g., width and height) may be smaller than or correspond to the dimensions of the electronic connection (e.g., width and height). This may advantageously reduce or minimize the thickness of the power supply. In some embodiments, one or more power supply components may alternatively or additionally be positioned on a substrate 710.

[0271] As described herein, in some embodiments, the wound contact layer may include a top portion 730 and a bottom portion 710. Figure 7B As shown, the wound dressing 700 may include a top portion 730, an electronic connection 745, and a power source (e.g., battery) component 750 located on the electronic connection. For example, the component 750 may be printed directly onto the electronic connection using any of the techniques described herein. The connection 745 may be the anode of the power source, which may be connected to one or more electronic components to supply power. In some embodiments, one or more power source components may alternatively or additionally be positioned on the top portion 730, which may be a membrane. In some embodiments, as described herein, the wound may be sealed by a membrane positioned above a substrate, and the layer 730 may be a membrane.

[0272] In some embodiments, power supply components 750 and 720 may form an integrated power source when the top portion 730 is positioned above the bottom portion 710 of the wound contact layer. For example, component 750 may be positioned directly or substantially directly above component 720. In some cases, one or more dielectric or insulating materials may be positioned between the two components 750 and 720 to form a power source.

[0273] Figure 7CAn exploded view of dressing 700 is shown, with a top portion 730 of the substrate positioned on a bottom portion 710 of the substrate. Power supply components 750 and 720, which may correspond to the anode and cathode of a power source, respectively (or vice versa), are illustrated as stacked on top of each other. Electrolyte material 760 is positioned between components 750 and 720 to allow for the generation of electricity. Connectors or electrodes 745 (connected to power supply component 750) and 715 (connected to power supply component 720) can be used to deliver electricity to one or more electronic components located in or on the dressing, as described herein. Figure 7D The illustration shows an assembled view of the dressing 700, illustrating electrodes 745 and 715 configured to deliver power supplied by an integrated power source. In some embodiments, multiple pairs of power supply components may be utilized. The power supply components can be protected from fluids or other substances by being sandwiched between portions of a substrate and, in some cases, encapsulated in a coating as described herein.

[0274] Figure 8 The illustrations depict power integration in wound dressings implementing sensors according to some embodiments. Schematic diagram 800A illustrates the integration of a button or coin cell battery 807 with two electrodes 801 (e.g., cathode and anode), insulating material 803 positioned between the electrodes, and a coating or sealant 805 surrounding the battery 807 and electrodes 801. Schematic diagram 800B illustrates the integration of a foil-sealed or paper battery 809 with two electrodes 801 (e.g., positive and ground), insulating material 803 positioned between the electrodes, and a coating or sealant 805 surrounding the battery 809 and electrodes 801. Schematic diagram 800C illustrates... Figures 7A-7D The diagram illustrates the integration of a power source (e.g., a battery). Two electrodes 801 (e.g., a cathode and an anode), an insulating material 803 positioned between the electrodes, and a coating or sealant 805 surrounding the battery chemistry 811 and the electrodes 801 are also shown. The battery in schematic 800C may be thinner than the batteries 807, 809 in schematics 800A and 800B. This is at least partially feasible because the battery chemistry 811 is stacked as described herein.

[0275] Figure 9An integrated wound dressing 900 with a power supply and implemented sensors is illustrated according to some embodiments. As described herein, the wound dressing 900 includes a substantially flexible wound contact layer 910. The wound contact layer 910 includes a plurality of perforations 920 configured to allow fluid (e.g., wound exudate) to pass through the wound contact layer for removal from the wound. As described herein, the wound contact layer 910 includes a plurality of sensors 940 and a controller or processor 950, such as an ASIC. The wound contact layer 910 includes a ground plane 930 that serves as a return path for current from the processor 950. The power supply and ground of one or more sensors may be isolated from the primary power supply and ground plane to isolate digital, analog, and / or patient contact paths for noise and safety purposes. As described herein, the wound contact layer 910 includes a cathode electrode for a power supply (e.g., a battery). One or both of a ground electrode 960 or a ground plane 930 may be printed on the wound contact layer using any of the techniques described herein.

[0276] As described herein, in some embodiments, the integrated wound dressing implementing the sensor may include one or more antennas configured to transmit data, such as measurements obtained by the sensor. The one or more antennas may include induction coils configured to receive power to recharge the power supply of the wound dressing. The one or more antennas may be printed on the wound contact layer as described herein.

[0277] In some embodiments, an integrated wound dressing implementing a sensor may be initialized or activated using one or more of the following mechanisms. In some embodiments, activation may include activating a controller for the wound dressing. The controller may be activated by providing an electrical connection between two or more terminals of an electronic circuit. For example, the wound dressing may be bent to activate the electronic circuit. As another example, a pull tab, switch, or other mechanism may be provided. Removing the pull tab may activate the electronic circuit by removing insulation or providing a conductive material (e.g., diffused silver ink or another conductive material) to create an electrical connection between the terminals. As yet another example, a bubble or other container with conductive material may burst or rupture, which would cause the conductive material (e.g., silver ink or another conductive material) to activate the circuit by providing an electrical connection between the terminals.

[0278] As another example, an active circuit element (e.g., a transistor) can operate as a switch, providing an electrical connection between terminals. An active circuit element can be turned on (or placed in a conductive operating mode) by applying an external electric field. For example, the gate of a transistor can be charged via a capacitive connection, thereby turning on the transistor. As another example, an external magnetic field can be used to activate a magnetic switch, such as a reed switch. As yet another example, a cover or similar mechanism can break or latch to apply pressure to a piezoelectric switch, generating an electrical signal to provide an electrical connection between terminals.

[0279] Encasing of electronic components In some implementations, one or more of the electronic components or at least some electronic connections of the wound dressing implementing the sensors may be encapsulated in a housing. This helps protect the components or connections from fluids, reduces electromagnetic interference (EMI), and prevents electrostatic discharge (ESD), including defibrillation pulses.

[0280] Figure 10 The illustration shows a wound dressing 1000 with a housing or enclosure for implementing a sensor, according to some embodiments. The dressing includes a controller 1015 with a circuit board 1010, which includes electronic components and connections 1040 and a power supply 1055. As described herein, the circuit board 1010 may be flexible or substantially flexible. The circuit board 1010 may be positioned on a bottom enclosure 1020, which may support the circuit board. Pins 1025 or other support elements or mechanisms, such as tabs, screws, notches, etc., are positioned on the bottom enclosure 1020 such that a top enclosure 1030 can enclose at least a portion of the circuit board 1010, which includes electronic components and connections 1040 and a power supply 1055. The top enclosure 1030 is configured to be supported by the pins 1025 when positioned above the bottom enclosure 1020 as indicated by arrow 1035. A latch or lock 1032 or another closing mechanism is positioned on the bottom enclosure 1020 to hold the top enclosure 1030 in place or to remove it. This design reduces the impact of any EMI on the circuit board components enclosed in the enclosure. The pins may be made of non-conductive material. Any ESD through the pins 1025 of the enclosure will not cause arcing to the circuit board components. In some cases, metal components (e.g., metal screws) may be omitted to reduce the risk of arcing.

[0281] The dressing 1000 includes a region or portion 1045 supporting one or more sensors configured to obtain measurements of one or more of the wound or the area surrounding the wound as described herein. As described herein, the dressing portion 1045 may include a substantially flexible wound contact layer. The wound contact layer may be separated from the circuit board 1010 by a distance 1050, which may help protect electronic components, connections, etc., from any EMI, electrosurgical spikes, defibrillation pulses, etc., that the wound contact layer may be subjected to when positioned on the wound.

[0282] The suffix can be designed to be small and lightweight so as to be less conspicuous to the patient. Alternatively or additionally, such a suffix can reduce or minimize any tension on the wound contact layer, thereby reducing patient discomfort or pain caused by movement of the suffix. In some embodiments, the suffix can be located outside the wound. For example, an external controller (e.g., controller 24) can be positioned within the suffix.

[0283] Monitoring impedance changes As disclosed herein, wound dressings implementing sensors (e.g.) Figure 1C The embodiments of the wound dressing 22) can measure one or more of the following: impedance, temperature, light, etc., relating to the wound or the area surrounding it. In some embodiments, sensors can be used to measure impedance changes in the wound or the area surrounding it. For example, sensors such as... Figure 11A The four-point probe measurement shown is used for impedance measurement. A drive signal, such as an AC drive signal, can be generated across the excitation or drive circuit or across pad 1102, and voltage measurement can be performed across a separate measurement sensor or measuring pad 1104. The pad can be as follows... Figure 11B The positioning is shown in the diagram. The eight measuring pads 1104 can be arranged at the corners of two concentric squares. The outer square can have a side of approximately 80 mm or any other suitable size. The inner square can have a side of approximately 30 mm or any other suitable size.

[0284] In some implementations, complex voltage measurements can be performed as follows: Table 1—Impedance Measurement Complex voltage measurements can identify the maximum and minimum voltages and phase angles (or times) behind the drive signal. Further details of impedance measurements are described in the following literature: International Patent Application No. PCT / EP2018 / 069886, filed July 23, 2018, entitled “Skewing Pads for Impedance Measurement,” which claims priority to U.S. Provisional Patent Application No. 62 / 536,774, filed July 25, 2017, entitled “Skewing Pads for Impedance Measurement,” each of which is incorporated herein by reference in its entirety.

[0285] In some embodiments, impedance measurement is based on AC measurement. An excitation signal can be capacitively coupled to the tissue via a sensor or pad with an insulating coating. A second, similar sensor or electrode can be placed at a distance and connected to ground. Upon application of the excitation signal, AC current flows through the tissue between the sensors.

[0286] A second pair of sensors or electrodes can be placed between the excitation electrodes and can be used to sense voltage. Each of these electrodes can be connected to one or more high-impedance amplifiers, the output of which can be fed to a differential amplifier. By measuring this output voltage and dividing it by the excitation current, the impedance between the measuring electrodes can be determined.

[0287] like Figure 11CAs illustrated, a pair of lock-in amplifiers can be used to detect voltage and current. Since the measured impedance can be relatively high, especially at electrodes that interface with tissue, it can be advantageous for the measuring electrode amplifier to have a high input impedance. The first-stage amplifier can be selected to have a high input impedance. These can be configured as non-inverting amplifiers to take advantage of this high input impedance. Examples include... Figure 11C The capacitors C1, C2, C3, and C4 shown in the diagram have low-frequency gain roll-off.

[0288] In some cases, for single-supply operation, the non-inverting input may need to be biased at the intermediate rail. This biasing may also require providing a DC path for the operational amplifier's input bias current. While this can be accomplished using a resistor divider at the non-inverting input, it can lead to the following: 1. The bias network reduces the input impedance unless a resistor of the same magnitude as the operational amplifier's input impedance is used (resistors of this value are impractically large).

[0289] 2. Large bias resistors contribute a large thermal noise component, which floods the input noise voltage of the operational amplifier, thereby reducing the overall signal-to-noise ratio.

[0290] In some embodiments, instead of using resistors, use Figure 5C The diagram illustrates a pair of reverse-biased diodes D1, D2, D3, or D4 to achieve input bias. Reverse-biased diodes present very high impedance (determined by reverse leakage) without contributing significantly to thermal noise. Diodes with very low reverse leakage can be selected. Reverse leakage also provides a DC path for the operational amplifier bias current.

[0291] In some embodiments, one or more measurements obtained by implementing sensors on a wound dressing may be affected by noise or interference generated by strain, stretching, contraction, or tearing of the substantially flexible wound contact layer. For example, in the case of impedance measurements, one or more sensors are connected to one or more measurement circuits (e.g., Figure 11C Variations in the impedance or resistance of electrical connections (as illustrated in the circuit diagram) can affect overall measurements. In some cases, when an electrical connection is stretched within its elastic constraints (so that it does not break or permanently deform), it becomes narrower and longer, and its resistance increases. Conversely, when an electrical connection is compressed (so that it does not bend), it becomes wider and shorter, and its resistance decreases. The impedance or resistance of connections or components may change when the substantially flexible wound contact layer supporting multiple electrical connections is subjected to strain or stress (e.g., due to patient movement). Because these resistance variations can affect measurements, including impedance measurements, monitoring such variations to ensure accuracy as described herein is advantageous.

[0292] Figure 12The illustration depicts a wound dressing 1200 configured to monitor changes in impedance according to some embodiments. As shown, a sheet or substrate 1230 supports one or more electronic components, including an electronic component or module 1202 having multiple connectors 1204 and multiple electronic connections 1210. The substrate 1230 may be stretchable or substantially stretchable and may include a wound contact layer as described herein. The electronic module 1202 may be any electronic component described herein, such as a sensor, a light source (e.g., an LED, an impedance sensor, a temperature sensor, etc.), a controller, or a processor (e.g., a communication processor), etc. The electronic connections 1210 may be traces printed on the substrate 1230, for example, using conductive copper, conductive ink (e.g., silver ink, copper ink, graphite ink, etc.). At least some of the electronic connections 1210 may be flexible or stretchable or substantially flexible or stretchable. The connectors 1204 may be configured to electrically connect the electronic module 1202 to the electronic connections 1210 (e.g., Figure 12 As shown herein, this electronic connection can be connected to other electronic modules (not shown) positioned on substrate 1230, on or within other parts of the wound dressing, or external to the wound dressing. Connector 1204 can be a pin, lead, block, etc. Alternatively, a socket can be used to support and electronically connect electronic module 1202. As used herein, printing material onto the substrate can include lamination, adhesion, or one or more of any other suitable techniques.

[0293] As shown in the figure, according to some embodiments, substrate 1230 may include a plurality of slits, holes, or perforations formed therein. As described herein, substrate 1230 may be perforated using one or more of the following: cold pin perforation, hot pin perforation, laser ablation perforation, ultrasonic or ultrasonic perforation, to allow the wound contact layer to be permeable to liquids and gases. In some embodiments, one or more of the perforation processes utilized may create a flat or substantially flat substrate around the holes rather than a non-uniform surface (e.g., annular surface). A flat or substantially flat substrate can help create a uniform layer when applying a biocompatible conformal coating (e.g., by spraying, brushing, pouring, etc.). Additionally, when creating perforations around components, using perforation processes that make the substrate surface non-uniform or substantially non-uniform may result in a greater risk of displacement of one or more components (e.g., electronic connection 1210 or electronic module 1202).

[0294] In some embodiments, perforations are made or patterned around one or more components (e.g., electronic connection 1210 or electronic module 1202) placed on substrate 1230. In some embodiments, the substrate may be perforated before one or more components are placed on it. Although a single electronic module 1202 is illustrated, multiple electronic modules may be used in some embodiments. Further details regarding the placement, perforation, or coating of components or connections are described in the following documents: International Patent Application No. PCT / EP2018 / 059333, filed April 11, 2018, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVEPRESSURE WOUND THERAPY DRESSINGS,” which claims No. 62 / 484316, filed April 11, 2017, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVEPRESSURE WOUND THERAPY DRESSINGS,” No. 62 / 484321, filed April 11, 2017, entitled “COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS,” and No. 62 / 484321, filed June 25, 2017, entitled “COMPONENT POSITIONING AND STRESS.” Priority to U.S. Provisional Patent Application No. 62 / 524564, entitled “Relief for Sensor Enabled Negative Pressure WOUND Therapy Dressings”;And International Patent Application No. PCT / EP2018 / 069883, filed on July 23, 2018, entitled “BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS”, which claims against International Patent Application No. 62 / 536921, filed on July 25, 2017, entitled “BIOCOMPATIBLE ENCAPSULATION OF COMPONENTSIN SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS”, and International Patent Application No. 62 / 536921, filed on July 25, 2017, entitled “BIOCOMPATIBLE ENCAPSULATION AND COMPONENT STRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS”. Priority is claimed by U.S. Provisional Patent Application No. 62 / 536926, entitled “Dressings”, and No. 62 / 556461, filed September 10, 2017, entitled “BIOCOMPATIBLE ENCAPSULATION AND COMPONENTSTRESS RELIEF FOR SENSOR ENABLED NEGATIVE PRESSURE WOUND THERAPY DRESSINGS”, each of which is incorporated herein by reference in its entirety.

[0295] In some embodiments, conductive traces 1240 (also referred to as calibration traces) surrounding or enclosing multiple electronic components are partially or completely positioned on the periphery of substrate 1230. In some embodiments, conductive traces 1240 may be substantially similar in construction to one or more traces 1210, and changes in the resistance of conductive traces 1240 may be measured and used as a substitute for changes in the resistance of one or more traces 1210. For example, conductive traces 1240 may have the same or substantially the same width as one or more traces 1210 and may be formed of conductive materials such as copper, conductive inks (e.g., silver ink, graphite ink, etc.). Conductive traces 1240 may be connected to monitoring circuitry (not shown), which measures changes in the impedance or resistance of conductive traces 1240. Monitoring circuitry may be part of a control module (e.g., a control module or controller). In some embodiments, monitoring circuitry may additionally or alternatively measure other types of electrical measurements (e.g., voltage or current) that have a defined mathematical relationship with resistance. For simplicity, monitoring circuitry is described as measuring resistance; however, those skilled in the art will readily understand that the measurement can be any associated measurable electrical characteristic.

[0296] Conductive trace 1240 may include longitudinal and vertical portions, which substantially surround or enclose the entire periphery of the wound contact layer (e.g. Figure 12 As shown), the conductive trace 1240 can withstand stretching or strain of the dressing regardless of direction or force (and thus allow detection of resistance changes). In some embodiments, other alternative or additional configurations of the conductive trace 1240 may be employed, such as one or more individual traces extending longitudinally, vertically, or radially from the electronic component 1202 or one or more traces 410.

[0297] In some embodiments, the monitoring circuitry may acquire one or more resistance readings from the conductive trace 1240 for calibration. Calibration can be performed under stable and normal operating conditions of the wound dressing, such as in an environment with no stress or strain on the wound dressing or substantially no stress or strain. For example, calibration can be performed before the wound dressing is applied to a patient, such as during manufacturing, packaging, etc. Calibration provides a baseline reading, such as a baseline resistance, from which the change in resistance of the conductive trace 1240 from the baseline resistance can be measured during use of the dressing. In some embodiments, additional or alternative baseline readings may be acquired from the conductive trace 1240 under strain or stress.

[0298] In some embodiments, the resistance of the conductive trace 1240 changes from a baseline resistance when the wound dressing is subjected to strain or stress. Monitoring circuitry, alone or in combination with a controller, can compare the new measurement or reading with a baseline reading to measure the resistance change and determine whether this change is within acceptable limits to ensure that the measurements obtained by one or more sensors are accurate. In some embodiments, this determination can be made by comparing the difference between readings with one or more thresholds.

[0299] In some embodiments, when the monitoring circuitry, alone or in combination with the controller, determines that the change is unacceptable, such as when the change exceeds one or more thresholds, one or more remedial actions may be performed. One or more remedial actions may include (1) delaying or ignoring one or more new sensor readings until the resistance change becomes acceptable again; (2) notifying the patient or caregiver to remove the stress or strain source; or (3) compensating for one or more new sensor readings to account for the resistance change, for example, by using calibration as described herein. Delaying one or more new sensor readings may involve deactivating one or more drive circuits or deactivating one or more affected sensors for one or more sensors affected by strain or stress. One or more remedial actions may be performed by one or more of the monitoring circuitry or the controller.

[0300] The monitoring circuit may include various circuit elements. For example, the monitoring circuit may include a voltage divider, a Wheatstone bridge, etc., to measure resistance changes. The monitoring circuit may additionally or alternatively include one or more active elements. As another example, the monitoring circuit may include a current source with an active switch (e.g., a transistor switch) that supplies a known current to a conductive trace. When the resistance increases beyond one or more thresholds, the switch may become active and indicate an unacceptable deviation from the baseline resistance. As yet another example, a constant current source may be used to generate the voltage required to identify the resistance. In some embodiments, the monitoring circuit may include a controller or microprocessor that can compare and perform remedies.

[0301] In some embodiments, a patient or caregiver may be alerted to remove a source of stress or strain. For example, one or more of a visual, auditory, tactile, or similar alarm may be generated.

[0302] Figure 13The illustration shows an arrangement of multiple conductive traces positioned on a wound contact layer 1300 according to some embodiments. In addition to conductive trace 1340, which substantially surrounds or encircles the entire periphery of the wound contact layer, conductive traces 1360 and 1370 can be positioned on the left and right sides of the wound contact layer, respectively, to independently measure resistance changes on the left and right sides. As shown, traces 1360 and 1370 can further extend to the bottom of the wound contact layer. Additionally, the bottom conductive trace 1380 can be positioned to independently measure resistance changes on the bottom side of the wound contact layer.

[0303] In some embodiments, trajectory 1360 may indicate a resistance change on the left side of the wound contact layer. Trajectory 1370 may indicate a resistance change on the right side of the wound contact layer. Trajectory 1380 may indicate a resistance change on the bottom side of the wound contact layer. The resistance change on the top side of the wound contact layer can be determined by subtracting the measurements obtained from trajectories 1360 and 1370 from the measurements obtained using trajectory 1340. These operations may be performed by monitoring circuitry as described herein. Figure 13 The conductive traces illustrated in the figure can be calibrated as described in this article.

[0304] In some embodiments, individual conductive traces can be positioned to measure the resistance change of each electrical component (e.g., sensor) block or one cluster of multiple clusters. For example, refer to Figure 1C The external conductive traces can be positioned around the periphery of the wound contact layer to measure the resistance changes of four external sensors, and the internal conductive traces can be positioned around four sensors in the center of the wound contact layer to measure the resistance changes of those sensors. In this arrangement, the measurements obtained by one or more sensors of a particular cluster can be adjusted based on the resistance changes measured by the conductive traces associated with that cluster of components.

[0305] Figures 14A-14D The illustration shows an arrangement of conductive traces for measuring changes in impedance according to some embodiments. For example... Figures 14A-14B As shown, in some embodiments, power to one or more electrical components 1440 or 1442 (e.g., one or more sensors) may be supplied by an electrical connection or track 1410. One or more measurements acquired by components 1440 or 1442 may be supplied by electrical connections 1420 or 1422, respectively. A conductive track 1430 may be used to measure the resistance change of components 1440 or 1442. Using this arrangement, the resistance change of a cluster of components (e.g., a cluster including components 1440 and 1442) can be obtained using a single conductive track 1430.

[0306] In some embodiments, such as Figure 14C-14DAs shown, power can be supplied to one or more components, such as component 1440, on track 1410, and to one or more conductive tracks, such as track 1430, on track 1450. This arrangement allows for the determination of resistance variations without affecting the power supply to electrical components, which can reduce interference or noise generated by one or more tracks 1430. Figure 14D As shown, the mask 1460 can be used for isolation to allow electrical traces to cross without creating a short circuit. Alternatively or additionally, isolation circuit elements (e.g., diodes or transistors) can be used for isolation. In some cases, one or more isolation circuit elements can be used to create a preferred path for resistance measurement.

[0307] In some cases, conductive traces used to measure resistance changes can be arranged as a grid across the wound contact layer. Each of the conductive traces, or any combination of conductive traces, can measure resistance changes associated with a specific portion of the wound contact layer, which may include a set of sensors. For example, as Figure 14E As shown, the grid of conductive tracks can include vertical tracks A, B, and C, and horizontal tracks X, Y, and Z. For example, at the intersection of tracks 1472, measuring the resistance change between tracks A and X can indicate the resistance change in the upper left portion of the grid. This resistance change can be correlated with the resistance change of one or more sensors located in the upper left portion. For example, at the intersection of tracks 1474, measuring the resistance change between tracks A and Y can indicate the resistance change in the grid portion located below the upper left portion. This resistance change can be correlated with the resistance change of one or more sensors located in the grid portion (below the upper left portion). The arrangement of the conductive tracks can provide one or more paths for measuring the resistance change of portions of the wound contact layer.

[0308] In some implementations, the monitoring circuitry or controller may compensate for one or more new sensor readings based on detected resistance changes. The measurements from one or more new sensors may be adjusted based on at least one of the following: a determined resistance change, deviation from one or more thresholds, etc. For example, one or more compensation factors (e.g., bias or scaling factors) may be applied to one or more new sensor readings. In some embodiments, one or more sensors may alternatively or additionally be equipped with strain gauges or similar circuitry (not shown) to individually calibrate and compensate for the effects of resistance changes on the sensor readings.

[0309] In some implementations, one or more of the methods described herein can be used to additionally or alternatively detect and compensate for impedance or resistance changes in one or more sensors due to strain, stretching, shrinkage, or tearing of the substrate. In some cases, one or more conductive traces may have different dimensions or materials compared to the sensor traces, making them more or less sensitive to strain, stretching, shrinkage, or tearing.

[0310] In some embodiments, one or more conductive traces may also improve protection against noise, including electrostatic discharge (ESD). For example, conductive traces may be positioned around the perimeter of a substrate to prevent ESD. Additional conductive traces may be connected to the conductive traces positioned on the perimeter. Such one or more conductive traces provide a path for ESD spikes. The conductive traces positioned on the perimeter and one or more additional conductive traces may be positioned away from one or more electronic components, such as sensors. The conductive traces positioned on the perimeter (or any other one or more conductive traces) may be connected to one or more resistors to prevent ESD. The one or more resistors may be carbon resistors. In some cases, one or more calibration traces may act as induction coils configured to receive power wirelessly.

[0311] Antenna for remote communication In some embodiments, a controller or control module (such as control module 330) configured to connect to a wound dressing may include one or more antennas for wireless communication. The one or more antennas may be used to transmit measurement data collected by one or more sensors on the wound dressing. The one or more antennas may also be used to wirelessly receive power from a power source or to transmit power to the wound dressing. For example, the antennas may include one or more loops that facilitate the wireless transmission or reception of power.

[0312] Figures 15A-15B The illustration shows a controller 1500 including an antenna 1510 that surrounds a plurality of electrical components 1530, which may also include a battery. Antenna 1510 and / or any antenna described herein (including antennas 1610 and 1710) may be positioned around one or more calibration tracks as described herein. The electronic components 1530 and antenna 1510 may be supported on a substrate (e.g., a circuit board). By completely or substantially surrounding the electrical components 1530, the antenna advantageously provides the desired communication range or good receive / transmit characteristics regardless of orientation, which may be referred to as 360-degree coverage. The illustrated design achieves these and other advantages while limiting interference to the electrical components and complying with applicable communication standards, such as ISO / IEC (International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC)) antenna standards.

[0313] Antenna 1510 may include copper wires, substrate traces, or lines. Antenna 1510 may be etched or printed. For example, antenna 1510 may include printed traces on a substrate, and the printed traces may include conductive copper or conductive ink, such as silver ink, graphite ink, etc.

[0314] As shown in the figure, antenna 1510 can be shaped such that it surrounds electrical component 1530 of controller 1500. The pattern or shape of antenna 1510 may vary depending on the embodiment. Thus, although antenna 1510 is illustrated as being arranged in a generally rectangular (or generally octagonal) configuration, antenna 1510 can be in approximately any shape as it surrounds or encloses electrical component 1530. For example, antenna 1510 can be rectangular, square, circular (circular or annular), L-shaped, C-shaped, W-shaped, G-shaped, D-shaped, or U-shaped, including straight or curved corners, etc. In some cases, as described herein, it may be advantageous for antenna 1510 to include smooth turns / corner transitions rather than sharp corner turns.

[0315] Antenna 1530 may include a combination of one or more straight, curved, or arcuate portions. For example, antenna 1510 may include one or more of the following: a straight trace, an inverted F-shaped trace, a meandering trace, a circular trace, an arcuate trace, a twisted trace, a spiral trace, etc. In some cases, antenna 1510 may be shaped such that it generally outlines the contour of the outer edge of controller 1500 (e.g., positioned along the periphery of a substrate) or surrounds electrical component 1530.

[0316] Antenna 1510 can be configured as a near-field antenna. For example, antenna 1510 can support near-field communication (NFC), enabling communication to be established when a communication device is brought within a specific range of antenna 1510. The specific range can vary between embodiments. For example, the specific range may include, but is not limited to, about one wavelength of antenna 1510, or within about 2, 4, 6, 8, 10, 12, 15, or 20 cm (+ / - a few centimeters). In some embodiments, the antenna can provide spherical coverage rather than just 360-degree planar coverage.

[0317] Antenna 1510 can be classified as a Category 4 antenna as defined by ISO / IEC 14443. For example, antenna 1510 can be located within an area defined by any of the following: (1) an outer rectangle of 50 × 27 mm and an inner rectangle of 35 × 13 mm, centered on the outer rectangle with a corner radius of 3 mm; or (2) an outer circle of 41 mm in diameter and an inner circle of 24 mm in diameter concentric with the outer circle. In some embodiments, antenna 1510 can be classified as another category, such as Category 1, 2, 3, 5, 6, or 7.

[0318] In some cases, the substrate of controller 1500 may be a multilayer circuit board (e.g., with four layers), and antenna 1510 may include traces occupying several layers of the multilayer circuit board. For example, antenna 1510 may surround electrical components 1530 on some or all of the multiple layers.

[0319] Via 1540 can be used to interconnect portions of antenna 1510 on each layer. For example, via 1540 can provide electrical connections between each portion of antenna 1510, and in some cases, can electrically connect antenna 1510 to one or more of electrical components 1530 (e.g., radio frequency (RF) circuitry or microprocessors, power supplies (e.g., batteries), etc.). Via 1540 can advantageously isolate antenna 1510 from electrical components 1530, thereby reducing the possibility of interference with the reception / transmission of antenna 1510. Additionally or alternatively, via 1540 can improve immunity to interference with the use of antenna 1510 for transmission or reception. Figure 15A and Figure 15B As shown, in some cases, the controller 1500 includes four vias 1540 on each layer, each layer including a portion of the antenna 1510. For example, the vias 1540 may allow the antenna 1510 to be electrically connected to RF circuitry located on another layer or several layers of the circuit board. For example, two vias 1540 of the antenna 1510, corresponding to positive and negative terminals, may be connected to the positive and negative terminals of the RF circuitry, as shown by connections 1544 and 1546, respectively, which is included in a plurality of electronic components 1530.

[0320] In some cases, certain components of the controller 1500 can be encapsulated with EMC shielding. For example, batteries or other hardware can be encapsulated in this way to limit or reduce the possibility of interference between the antenna 1510 and the encapsulated components.

[0321] It may be advantageous for antenna 1510 to surround a large portion of controller 1500 to provide the widest possible coverage area. Therefore, antenna 1510 may extend substantially to the periphery or edge of controller 1500, and in some cases, the antenna loop may be manufactured in a shape similar to controller 1500. Embodiments of antenna 1510 provide various configurations in which antenna 1510 surrounds a portion of controller 1510. For example, antenna 1510 may be shaped such that it surrounds a portion of the controller, such as 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 85, or approximately 100% (+ / - a few percentages) of the area of ​​controller 1500.

[0322] The performance of antenna 1510 can be determined by a number of antenna parameters. For a rectangular antenna, these parameters may include the overall size of the antenna, the average size of the antenna, the trace thickness, the trace width, the size of the gap between the traces, the number of turns of the antenna, the equivalent diameter or turn exponent of the trace, and others. The performance of a circular antenna can be based on the following and others: the diameter of the antenna, the trace thickness, the trace width, the size of the gap between the traces, the number of turns of the antenna, the equivalent diameter of the trace, the turn exponent, the average diameter of the antenna, or the average perimeter of the antenna. Therefore, the performance of any antenna can be based on the shape of the antenna. Therefore, because the shape of the antenna varies among various embodiments, the applicable antenna parameters can vary.

[0323] Antenna 1510 may include a number of turns (sometimes referred to as loops or tracks). The number of turns of antenna 1510 may vary between embodiments. For example, although Figure 5A The antenna 1510 shown includes three turns, but in some embodiments, the antenna 510 may have fewer or more turns. For example, the antenna may include 1, 2, 3, 4, 5, 7, 8, 9, 10 or more turns. Furthermore, the antenna may include one or more partial turns.

[0324] The thickness of antenna 1510 and the dimensions of the gap between the antenna traces may vary between embodiments. For example, the thickness of the antenna may be uniform along the entire length of the antenna. Alternatively, the thickness of the antenna may vary along the length of antenna 1510. Similarly, the gap between the traces of antenna 1510 may be uniform throughout or may vary along the length of antenna 1510.

[0325] In some cases, the design of the antenna 1510 surrounding the electrical components 1530 provides a more reliable and efficient wireless communication compared to a design where the antenna is confined to a specific area of ​​the substrate of the controller 1500 (e.g., confined to a single corner).

[0326] For example, a user can use a Near Field Communication (NFC) device to scan the controller 1500 and thus communicate with it. The NFC device can be configured to communicate with the controller via the antenna 1510 when the device moves within a specific distance of the antenna 1510. Therefore, by configuring the antenna 1510 such that it surrounds the electrical component 1530, thereby surrounding a relatively wide area of ​​the controller 1500, the user can reliably communicate with the controller 1500 by bringing the device into the communication range from virtually any direction or angle relative to the controller 1500.

[0327] In contrast, if the antenna is confined or limited to a specific area of ​​the controller's substrate (e.g., positioned in a corner), then in some cases, it may be difficult for the user to communicate with the controller via an NFC device. For example, the user could scan the device on the controller, but might not be able to establish a communication link to the antenna's location. Therefore, by positioning the antenna 1510 to surround the electrical component 1530 (e.g., as...), Figures 15A-15B As shown), and surrounding a relatively wide area of ​​the substrate, the user may be able to communicate with the controller 1500 via an NFC device, regardless of which area of ​​the controller 1500 the user swipes the device on. It should be understood that other forms of communication using the antenna 1510 are contemplated. For example, wireless communication can be performed via any wireless interface (e.g., via RFID, far-field, etc.) when the communication device is placed within the communication range of the antenna 1510.

[0328] Figure 15B The illustration shows the wound dressing 1522 connected to the sensor. Figure 15A The controller 1500, the wound dressing can be similar to Figure 1C The wound dressing 22 implementing the sensor. As shown, the controller 1500 is connected to the wound dressing 1522 implementing the sensor via connector 1550. It can be similar to... Figure 1C Connector 1550 of connector 28 is configured to allow communication between controller 500 and wound dressing 1522. As described herein, the information transmitted between controller 500 and wound dressing 1522 via connector 1500 may include, but is not limited to, sensor information, such as impedance, temperature, or optical characteristics obtained from one or more of the wound or its surroundings.

[0329] Figures 16A-16B The diagram illustrates a controller 1600 including an antenna 1610 and electrical components 1630. As described herein, the antenna 1610 may have... Figure 15A and Figure 15B The antenna 1610 does not surround the electrical component 1630, unlike the antenna 1510. Instead, the antenna 1610 is positioned away from one or more electrical components 1630. For example, the antenna 1610 may be positioned in a first region 1624 of a circuit board, which is different from a second region 1626 of the circuit board where the electrical component 1630 is located.

[0330] In some cases, by configuring antenna 1610 to be positioned away from one or more electrical components 1630, the possibility of interference between antenna 1610 and electrical components 1630 is reduced. As shown, the coverage area of ​​antenna 1610 can include most of the controller 1600 opposite the electrical components. The controller can include multiple antennas 1610 at various locations on the controller 1600. Configuring antenna 1610 at multiple locations can advantageously increase the coverage area of ​​antenna 1610. For example, multiple antennas can be placed in multiple corners of the controller 1600, thereby allowing antenna 1610 to be read from any of those corners.

[0331] Figure 16B The illustration shows a wound dressing 1622 connected to the sensor. Figure 16A The controller 1600, the wound dressing can be similar to Figure 1C The wound dressing 22 with the sensor is shown in the figure. Figure 15A Unlike antenna 1510, antenna 1610 is positioned away from connector 1600. Because antenna 1610 is positioned away from connector 1600, this configuration reduces the likelihood of noise or interference being introduced from antenna 1610, which could interfere with or reduce communication between controller 1600 and wound dressing 1622 via connector 1650. Similarly, the illustrated configuration reduces the likelihood of noise or interference being introduced from connector 1650, which could interfere with or reduce wireless communication between controller 1600 and antenna 1610.

[0332] Figures 17A-17B The illustration shows a controller 700 including an antenna 1710 positioned such that it substantially surrounds an electrical component 1730 (which may be similar to electrical component 1530) except for a region 1716, which is connected via a connector 1750 to a wound dressing 1722 implementing a sensor. Figure 1C The wound dressing 22 implementing the sensor is similar. As described herein, the antenna 1710 may have... Figure 15A and Figure 15BThe antenna 1710 has no features other than those described herein. However, compared to antennas 1510 and 1610, antenna 1710 substantially surrounds electrical component 1730, but does not overlap with connector 1750 when controller 1700 and wound dressing 1722 implementing the sensor are connected. By positioning antenna 1710 such that it substantially surrounds electrical component 1730 (e.g., completely surrounds electrical component except for the opening in region 1716), the antenna can advantageously provide more reliable and efficient wireless communication as described herein. In addition, when controller 1700 is connected to wound dressing 1722 via connector 1700, configuring antenna 1710 such that it does not overlap (or minimally overlaps) with connector 1700 can advantageously reduce the possibility of introducing noise or interference as described herein.

[0333] Although this article is about Figure 15A-17B The described embodiments depict antennas incorporated into a controller; however, any one or more antennas as described herein can be incorporated into a wound dressing, such as one supported on a substantially flexible wound contact layer. For example, one or more antennas as described herein can be printed as one or more connections or traces on a wound contact layer (such as a substantially stretchable wound contact layer). In some cases, one or more antenna traces can be positioned on a substantially non-stretchable material (as described herein) such that when the wound dressing (e.g., Figure 1C In the wound dressing 22), when placed under pressure on a patient, the resonant frequencies of one or more antennas remain fixed. For certain communication protocols, such as RFID, fixing one or more resonant frequencies may be advantageous. In the absence of a controller, one or more antennas can be used to transmit measurement data collected by one or more sensors. One or more antennas can also be used to wirelessly receive power from a power source.

[0334] In some cases, as described herein, the resonant frequency of an antenna positioned on a substantially flexible substrate can change when the substrate is stretched or torn. The change in resonant frequency can be measured from one or more electromagnetic signals emitted by the antenna. For example, the antenna can be connected to an oscillator driver. Alternating current output signals can be used for communication, while direct current output signals can be used to measure strain. In some cases, the antenna can be connected to one or more circuits whose electrical characteristics change according to strain. As described herein, such circuits can include one or more calibration tracks, strain gauges, etc. As described herein, the antenna and circuitry can form a resonant circuit whose resonant frequency can change when the substrate is stretched or torn. The change in resonant frequency can be measured from one or more electromagnetic signals emitted by the antenna. The change in resonant frequency can indicate the degree of stretching or tearing of the substrate and, as described herein, a change in resistance. The change in the resonant frequency of the antenna or the circuitry including the antenna can be used with any of the embodiments described herein to measure changes in resistance.

[0335] Additional variants In some embodiments, the wound monitoring and / or treatment system includes a wound dressing configured to be positioned over a wound. The wound dressing includes a substantially stretchable wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the electronic components. The plurality of electronic components may include a plurality of sensors configured to acquire measurement data of at least one of the wound or its surrounding area. The plurality of electronic components may include at least one controller configured to control at least some of the sensors, and the at least one controller is configured to operate faultlessly when the at least one controller flexes due to strain on the wound dressing.

[0336] The system described in the preceding paragraph may include one or more of the following features: The at least one controller may be compressible to increase its resilience to flexure. The at least one controller may be pre-stressed. The wound dressing may include a coating covering at least some of the plurality of electronic components and at least some of the plurality of electronic connections, and the coating may compress the at least one controller when applied to the wound dressing. The coating may be hydrophobic and biocompatible. The wound dressing may include an antenna configured to transmit the measurement data to a remote computing device.

[0337] One or more of the systems described in the preceding paragraphs may include one or more of the following features. The system may include a power source positioned on the wound contact layer and configured to power the plurality of electronic components. The power source may not be enclosed in a separate housing or enclosure. The wound contact layer may include a first portion and a second portion, the power source may include an anode supported by the first portion of the wound contact layer and a cathode supported by the second portion of the wound contact layer, and the power source may include an electrolyte layer positioned between the anode and the cathode.

[0338] One or more of the systems described in the preceding paragraphs may include one or more of the following features. The at least one controller may be configured to be activated by one or more of the following: bending the wound dressing, activating an activation switch, causing bubbles in the conductive material to burst, charging a transistor, activating a magnetic trigger, or triggering a piezoelectric element. The system may be configured not to be physically connected to an external controller that controls any of the plurality of sensors or receives any of the measurement data.

[0339] In some embodiments, the wound monitoring and / or treatment system includes a wound dressing configured to be positioned over a wound. The wound dressing includes a substantially stretchable wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the electronic components. The plurality of electronic components may include: a plurality of sensors configured to acquire measurement data of at least one of the wound or its surrounding area; and a controller configured to be connected to the wound dressing. The control module may include: at least one controller configured to acquire the measurement data from the plurality of sensors; and a power supply configured to provide power to the at least one controller and the plurality of sensors, the at least one controller and the power supply being encapsulated in a housing.

[0340] One or more of the systems described in the preceding paragraphs may include one or more of the following features. The enclosure may include a first portion supporting the at least one controller and power supply, and a second portion configured to be attached to at least one pin positioned on the first portion. The enclosure may be configured to substantially shield the at least one controller from electromagnetic interference (EMI) and electrostatic discharge (ESD).

[0341] In some embodiments, the wound monitoring device includes a wound dressing configured to contact and position itself in contact with a wound. The wound dressing includes a substantially stretchable wound contact layer supporting a plurality of sensors and a plurality of conductive tracks. The plurality of sensors are configured to acquire measurements of at least one of the wound or its surrounding area. The plurality of conductive tracks are electrically connected to the plurality of sensors. The wound contact layer may also support at least one calibration track electrically connected to monitoring circuitry configured to measure a first resistance change of the at least one calibration track, the first resistance change of the at least one calibration track corresponding to resistance changes of at least some of the plurality of conductive tracks.

[0342] The device described in the preceding paragraph may include one or more of the following features. The at least one calibration track may be located at least partially on the periphery of the wound contact layer. The at least one calibration track may include a plurality of calibration tracks, and each of the calibration tracks is associated with a specific sensor among the plurality of sensors. The monitoring circuit may also be configured to measure the baseline resistance of the at least one calibration track when the intact wound contact layer is not stretched, and to determine a first resistance change of the at least one calibration track based on the difference between the baseline resistance and the resistance of the at least one calibration track due to stretching and / or tearing of the wound contact layer. The monitoring circuit may also be configured to adjust the measurement obtained by one of the plurality of sensors based on the first resistance change. The monitoring circuit may also be configured to control at least some of the plurality of sensors to delay one or more measurement results in response to determining that the first resistance change exceeds a threshold.

[0343] One or more of the devices described in the preceding paragraphs may include one or more of the following features. The device may include a controller configured to control at least some of the plurality of sensors to obtain one or more measurement results in response to determining that a second resistance change is below the threshold, the second resistance change being measured after a first resistance change is measured. At least some of the plurality of sensors may include one or more sensors configured to measure impedance. The at least one calibration track may include a plurality of calibration tracks configured to measure a plurality of first resistance changes associated with a plurality of different regions of the wound contact layer. The at least one calibration track may be connected to a different power source than the plurality of sensors.

[0344] In some embodiments, a method of operating a wound monitoring device includes a wound dressing comprising a substantially stretchable wound contact layer supporting a plurality of sensors and a plurality of conductive tracks, the plurality of sensors being configured to acquire measurements of at least one of a wound or the area surrounding a wound, the plurality of conductive tracks being electrically connected to the plurality of sensors, the method comprising using monitoring circuitry of the wound monitoring device to measure a first resistance change of at least one calibration track positioned on the wound contact layer. The first resistance change of the at least one calibration track may correspond to resistance changes of at least some of the plurality of conductive tracks. The at least one calibration track may be positioned at least partially around the periphery of the wound contact layer.

[0345] The method described in one or more of the preceding paragraphs may include one or more of the following features. The at least one calibration track may include a plurality of calibration tracks, and each of the calibration tracks is associated with a specific sensor among the plurality of sensors. The method may further include: measuring the baseline resistance of the at least one calibration track when the intact wound contact layer is not stretched; and determining a first resistance change of the at least one calibration track based on the difference between the baseline resistance and the resistance of the at least one calibration track due to stretching and / or tearing of the wound contact layer.

[0346] The method described in one or more of the preceding paragraphs may include one or more of the following features. The method may include adjusting a measurement obtained by one of the plurality of sensors based on the first resistance change by the monitoring circuit. The method may include, by a controller of the wound monitoring device: receiving the first resistance change from the monitoring circuit; determining that the first resistance change exceeds a threshold; and controlling at least some of the plurality of sensors to delay obtaining one or more measurement results. The method may include, by the controller: determining that a second resistance change measured after measuring the first resistance change is below the threshold; and controlling at least some of the plurality of sensors to obtain one or more measurement results. The at least some of the plurality of sensors include one or more sensors configured to measure impedance.

[0347] In some embodiments, the wound monitoring device includes: a wound dressing configured to contact and position itself in contact with a wound, the wound dressing including a substantially stretchable wound contact layer supporting a plurality of sensors configured to acquire measurements of the wound; and a controller configured to connect to the wound dressing and further configured to receive measurements acquired by the plurality of sensors on the wound dressing. The controller may include a circuit board supporting a plurality of electrical components and an antenna configured to communicate with at least one of the wound dressing or a telecomputing device. The antenna may at least partially surround the plurality of electrical components.

[0348] In some embodiments, the wound monitoring device includes a wound dressing and a controller. The wound dressing may be configured to contact and position itself against a wound, and may include a substantially stretchable wound contact layer supporting a plurality of sensors. The sensors may be configured to acquire measurements of the wound. The controller may be configured to connect to the wound dressing. The controller may also be configured to receive measurements acquired by the plurality of sensors on the wound dressing. The controller may include a circuit board supporting a plurality of electrical components and an antenna. The antenna may be configured to communicate with at least one of the wound dressing or a remote computing device. The antenna may at least partially surround the plurality of electrical components.

[0349] One or more of the devices described in the preceding paragraphs may also include any combination of the following features described in this paragraph, as well as other features described herein. The antenna may surround the entire area of ​​the circuit board, including the plurality of electrical components, except for a portion of the area including the plurality of connections configured to be connected to the wound dressing. The antenna may surround the entire area of ​​the circuit board, including the plurality of electrical components.

[0350] In some embodiments, the wound monitoring device includes a wound dressing and a controller. The wound dressing may be configured to contact and position itself against a wound, and may include a substantially stretchable wound contact layer supporting a plurality of sensors. The sensors may be configured to acquire measurements of the wound. The controller may be configured to connect to the wound dressing and may also be configured to receive measurements acquired by the plurality of sensors on the wound dressing. The controller may include a circuit board supporting a plurality of electrical components and an antenna. The antenna may be configured to communicate with at least one of the wound dressing or a telecomputing device, and the antenna is positioned in a first region of the circuit board, which differs from a second region where the plurality of electrical components are positioned.

[0351] One or more of the devices described in the preceding paragraphs may also include any combination of the following features described in this paragraph, as well as other features described herein. The antenna may substantially surround the entire first region. The antenna may be C-shaped. The antenna may be L-shaped. The antenna may be rectangular, square, or circular. The antenna may be positioned away from the plurality of electrical components. The antenna may include multiple loops. The antenna may include three loops.

[0352] One or more of the devices described in the preceding paragraphs may also include any combination of the following features described in this paragraph, as well as other features described herein. The wound contact layer may also support multiple conductive traces electrically connecting the plurality of sensors. At least some of the conductive traces may be configured to be electrically connected to the controller. The circuit board may include multiple layers, and at least some of the multiple layers of the multilayer circuit board support the antenna. The circuit board may include one or more vias configured to interconnect the antenna on each of the multiple layers.

[0353] One or more of the devices described in the preceding paragraphs may also include any combination of the following features described in this paragraph, as well as other features described herein. The antenna may be configured as a near-field antenna. The antenna may be positioned within an area defined by a 50 × 27 mm outer rectangle and a 35 × 13 mm inner rectangle of the controller, wherein the inner rectangle is centered within the outer rectangle. The antenna may include a 3 mm angular radius. The antenna may be located within an area defined by an outer circle of 41 mm diameter and an inner circle of 24 mm diameter of the controller, wherein the inner circle is concentric with the outer circle. The antenna may include copper wire, etched, or printed antenna material.

[0354] Other variations In some embodiments, one or more sensors may be positioned within one or more layers of a wound dressing or another structure not in direct contact with the wound. In this case, the sensors may measure one or more of impedance, temperature, color, pressure, etc., associated with the wound and / or the area surrounding it. For example, one or more sensors may be positioned above a dressing layer that transmits or absorbs wound exudate. In this example, one or more sensors may measure one or more of the impedance, temperature, color, etc., of the wound exudate. These measurements can be used to determine the state of the wound, which (as described herein) may include wound healing or non-healing.

[0355] In some embodiments, one or more electronic components may be positioned on one side of the wound contact layer opposite to the wound-facing side. The systems and methods described herein are equally applicable to such arrangements. Any wound dressing embodiment described herein may include features of any other wound dressing embodiment described herein. Similarly, any controller described herein may include features of any other wound dressing embodiment described herein. Furthermore, any device, component, or module described in a particular embodiment may include features of any other described embodiment of the device, component, or module.

[0356] Any values ​​for thresholds, limits, durations, etc., provided herein are not intended to be absolute and are therefore approximate. Furthermore, any thresholds, limits, durations, etc., provided herein may be fixed or automatically or by the user. Additionally, relative terms such as exceeding, greater than, less than, etc., used herein relative to a reference value are intended to also cover being equal to the reference value. For example, exceeding a positive reference value may include being equal to or greater than the reference value. Furthermore, relative terms such as exceeding, greater than, less than, etc., used herein relative to a reference value are also intended to cover the opposite relationships disclosed, such as being below, less than, greater than, etc., relative to a reference value. Moreover, although various processes may be described in boxes regarding determining whether a value meets or does not meet a particular threshold, these boxes can be understood similarly, for example, regarding values ​​that (i) are below or above a threshold or (ii) meet or do not meet a threshold.

[0357] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example shall be understood to be applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All features disclosed in this specification (including any appended claims, abstract, and drawings), or all steps of any method or process so disclosed, may be combined in any combination except for at least some mutually exclusive combinations of such features or steps. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel feature or any novel combination of features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel feature or any novel combination of steps of any method or process so disclosed.

[0358] While certain embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and changes can be made to the form of the methods and systems described herein. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated or disclosed process may differ from those shown in the accompanying drawings. According to embodiments, some of the steps described above may be removed, and other steps may be added. For example, the actual steps or the order of steps taken in the disclosed process may differ from those shown in the figures. According to embodiments, some of the steps described above may be removed, and other steps 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, etc., may include logic circuitry. Furthermore, the features and attributes of the specific embodiments disclosed above can be combined in different ways to form other embodiments, all of which fall within the scope of this disclosure.

[0359] While this disclosure includes certain embodiments, examples, and applications, those skilled in the art will understand that this disclosure extends beyond the specific embodiments disclosed herein to other alternative embodiments or uses, as well as obvious modifications and equivalents thereof, including embodiments that do not provide all the features and advantages described herein. Therefore, the scope of this disclosure is not intended to be limited to the specific disclosure of the preferred embodiments herein, but may be defined by the claims set forth herein or to be proposed herein.

[0360] Conditional language, such as “can,” “may,” “may,” or “may,” unless explicitly stated otherwise or otherwise understood in the context in which it is used, is generally intended to express that certain embodiments include certain functions, elements, or steps that are not included in other embodiments. Therefore, such conditional language is not generally intended to imply that one or more embodiments require features, elements, or steps in any way, or that one or more embodiments must include logic for determining whether such features, elements, or steps are included in or performed in any particular embodiment, with or without user input or prompting. The terms “comprising,” “including,” “having,” etc., are synonymous and used in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive sense (but not in its proprietary sense) so that, when used, for example, to connect lists of elements, the term “or” indicates one, some, or all of the elements in the list. Additionally, besides having its ordinary meaning, the term “each” as used herein can refer to any subset of the set of elements to which the term “each” is applied.

[0361] Unless otherwise explicitly stated, union language such as the phrase “at least one of X, Y, and Z” is understood in context as generally used to indicate that an item, term, etc., may be X, Y, or Z. Therefore, such union language generally does not imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0362] The degree language used herein, such as the terms “approximately,” “about,” “substantially,” and “basically,” refers to a value, quantity, or characteristic that is close to, yet still performs, the desired function or achieves the desired result. For example, the terms “approximately,” “about,” “substantially,” and “basically” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the specified quantity. As another example, in some embodiments, the terms “substantially parallel” and “basically parallel” refer to a value, quantity, or characteristic that deviates from exact parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

[0363] The scope of this disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims in this section or elsewhere in this specification or future. The language of the claims will be interpreted broadly based on the language used in the claims and is not limited to the examples described in this specification or during the examination of the application, which should be interpreted as non-exclusive.

Claims

1. A wound monitoring and / or treatment system, comprising: A wound dressing configured to be positioned above a wound, the wound dressing including a substantially stretchable substrate supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components. The plurality of electronic components include a plurality of sensors configured to acquire measurement data of at least one of the wound or the area surrounding the wound; and The plurality of electronic components include at least one controller positioned on a circuit board formed of reinforcing material, the at least one controller being configured to control at least some of the plurality of sensors, wherein the controller positioned on the circuit board is a processor on a silicon wafer. The silicon wafer has been pre-stressed and / or compressed to increase its resilience to flexural stress, so that it can operate without failure when it flexes due to strain on the wound dressing.

2. The system according to claim 1, wherein, The wound dressing includes a coating covering at least some of the plurality of electronic components and at least some of the plurality of electronic connections, wherein the material of the circuit board has been reinforced by the coating compressing the material of the circuit board when applied to the wound dressing; optionally, the coating is hydrophobic and / or biocompatible.

3. The system according to any one of the preceding claims, wherein, The wound dressing also includes an antenna configured to transmit measurement data to a remote computing device.

4. The system according to any one of the preceding claims, wherein, The at least one controller is configured to be activated by one or more of the following: bending the wound dressing, activating an activation switch, causing bubbles in the conductive material to burst, charging a transistor, activating a magnetic trigger, or triggering a piezoelectric element.

5. The system according to any one of the preceding claims, wherein, The substrate includes a plurality of perforations configured to allow fluid to pass through the substrate.

6. The system according to any one of the preceding claims further includes a negative pressure source configured to be fluidly connected to the wound dressing, the negative pressure source being configured to supply negative pressure to the wound.

7. A method of manufacturing a wound dressing, the wound dressing being configured to be positioned above a wound and used in a wound monitoring and / or treatment system, the method comprising: The circuit board, including the controller, is pre-strained by at least one of the following: Stretch at least a portion of the substantially flexible substrate of the wound dressing, position the circuit board on at least said portion of the substrate, and then relax at least said portion of the substrate; or The circuit board is compressed, and then positioned on the substrate. The substrate supports a plurality of sensors and a plurality of electronic connections. The sensors are configured to acquire measurement data of at least one of the wound or its surrounding area. The electronic connections connect at least some of the sensors to the controller, and the controller is configured to control at least some of the sensors. Specifically, pre-stressing the circuit board increases its elasticity to flexural stress and enables it to operate fault-free when it flexes due to strain applied to the substrate.

8. The method according to claim 7, wherein, Pre-stressing the circuit board further includes: positioning the circuit board on the substrate; covering at least a portion of the circuit board, including the coated portion, of the substrate; and shrinking the coating by curing the coating, thereby applying compression to at least the portion of the substrate including the circuit board; optionally, wherein the coating is at least one of biocompatibility or hydrophobicity.

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