Sensor-enabled negative pressure wound monitoring apparatus with different impedance inks

Abstract

To provide an improved wound monitoring and / or treatment system.SOLUTION: A sensor sheet of a wound monitoring and / or therapy apparatus can include one or more electrical connections. The electrical connections can include multiple conductive inks having different impedances. A track of a first conductive ink having a first impedance can be coupled to an electrical connector of an electronic component. A track of a second conductive ink having a second impedance can be coupled to the track of the first conductive ink.SELECTED DRAWING: Figure 2B

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to UK Provisional Application No. 1914443.5, filed October 7, 2019, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Embodiments of the present disclosure relate to sensor-integrated substrates that may be incorporated into wound dressings and systems, and in particular to design rules for such substrates.

[0003] 2. Description of Related Art Nearly every field of medicine can benefit from improved information about the condition of the tissue, organ, or system being treated, especially if such information is gathered in real time during treatment. Many types of treatments are still routinely performed without the use of sensor data collection, which instead rely on visual inspection by a caregiver or other limited means rather than quantitative sensor data. For example, in the case of wound treatment via dressings and / or negative pressure wound therapy, data collection is generally limited to visual inspection by a caregiver, and in many cases the underlying wound tissue may be obscured by a bandage or other visual obstruction. Even intact, unbroken skin may have underlying damage that is not visible to the naked eye, such as compromised blood vessels or deeper tissue damage that may lead to ulcers. Similar to wound treatment, during orthopedic treatments that require immobilization of a limb with a cast or other enclosure, only limited information about the underlying tissue is gathered. In the case of internal tissue repairs such as bone plates, continuous direct sensor-driven data collection is not performed. Additionally, braces and / or sleeves used to support musculoskeletal function do not monitor underlying muscle function or limb movement. Outside of direct treatment, common hospital room supplies such as beds and blankets could be improved by adding the ability to monitor patient parameters. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2005-532841 Summary of the Invention [Problem to be solved by the invention]

[0005] Such wound monitoring and / or treatment systems present inherent problems due to contact with tissue. In addition, the wound should heal without interference. At the same time, care must be taken to ensure that such systems are reliable and safe for use on human or animal tissue.

[0006] Thus, there is a need for improved wound monitoring and / or treatment systems. [Means for solving the problem]

[0007] In some cases, a sensor sheet (e.g., wound dressing) of a wound monitoring and / or therapy device includes a plurality of electronic components. The plurality of electronic components may include at least a first electronic component. The first electronic component may include a first electrical connector configured to electrically connect the first electronic component. The wound monitoring and / or therapy device may include a substantially flexible substrate. The substantially flexible substrate may include a first wound-facing side that supports the plurality of electronic components, and a second side opposite the first side. The wound monitoring and / or therapy device may include a first track of conductive ink having a first impedance. The first conductive ink may be present on the substantially flexible substrate. The first track of conductive ink may be electrically coupled to the first electrical connector of the first electronic component. The wound monitoring and / or therapy device may include a second track of conductive ink having a second impedance different from the first impedance. The second conductive ink may be present on the substantially flexible substrate. The second conductive ink track may be electrically coupled to the first conductive ink track.

[0008] The sensor sheet of the preceding paragraph may also include any combination of the following features described in this paragraph, among others described herein: The solder paste may be electrically coupled between the first electrical connector and the first electronic component. The solder paste may electrically couple the first electrical connector and the first electronic component. The first conductive ink may bond (e.g., form a better electrical connection) with the solder paste than with the second conductive ink. The second conductive ink track may be electrically coupled to the first electronic component via the first conductive ink track. The first conductive ink track may be a first track of the first conductive ink. The sensor sheet may include a second track of the first conductive ink coupled to the second conductive ink track. The second track of the first conductive ink may be electrically coupled to the first track of the first conductive ink via the second conductive ink track. The first conductive ink track may be a first track of the first conductive ink. The plurality of electronic components can include a second electronic component including a second electrical connector. The sensor sheet can include a second track of the first conductive ink coupled to the second electrical connector of the second electronic component.

[0009] The sensor sheet of either of the two preceding paragraphs may also include any combination of the following features described in this paragraph, among others described herein: The track of the second conductive ink may be coupled to the second track of the first conductive ink. The first electronic component may be electrically coupled to the second electronic component via the first track of the first conductive ink, the track of the second conductive ink, and the second track of the first conductive ink. The track of the second conductive ink may be the first track of the second conductive ink. The sensor sheet may include a second track of the second conductive ink coupled to the second track of the first conductive ink. The first electronic component may include at least one of a sensor, an amplifier, a capacitor, a resistor, an inductor, a controller, a processor, a diode, or a connector. At least one of the first conductive ink or the second conductive ink may include a silver ink.

[0010] The sensor sheet of any of the preceding three paragraphs may also include any combination of the following features described in this paragraph, among others described herein: The impedance variance due to stretching of the second conductive ink may be less than the impedance variance due to stretching of the first conductive ink. The first conductive ink may have a first width and the second conductive ink may have a second width greater than the first width. The thermal conductivity of the first conductive ink may be higher than the thermal conductivity of the second conductive ink. At least one of the first conductive ink or the second conductive ink may include an electrotextile. The electrotextile may be cotton.

[0011] The sensor sheet of any of the preceding four paragraphs may also include any combination of the following features described in this paragraph, among others described herein: The first conductive ink may include fibers. The fibers may reduce impedance dispersion due to stretching of the first conductive ink. The first impedance may be greater than the second impedance. The first conductive ink may be more conductive than the second conductive ink. At least a portion of the second conductive ink track may overlap at least a portion of the first conductive ink track. The second conductive ink track may be electrically coupled to the first conductive ink track using conductive glue. The second conductive ink track may be electrically coupled to the first conductive ink track using conductive tape. The first conductive ink may include a first amount of silver. The second conductive ink may include a second amount of silver different from the first amount.

[0012] Any feature of any of the methods described herein may be used with any feature of any of the other methods described herein. [Brief description of the drawings]

[0013] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1A] 1 illustrates a wound monitoring or therapy system. [Figure 1B] Illustrates a substrate that supports electronic components. [Figure 1C] Illustrates a substrate that supports electronic components. [Figure 2A] 2 shows a cross-sectional view of a portion of an exemplary wound monitoring and / or therapy device including an electronic component 204 electrically coupled to a substrate via solder paste and multiple electrical connections. [Figure 2B] 2B shows a cross-sectional view of FIG. 2A, further illustrating an embodiment of an electrical connection including multiple types of conductive inks. [Figure 2C] 2B shows a cross-sectional view of FIG. 2A, further illustrating an example of overlapping electrical connections. [Figure 2D] 2B shows a cross-sectional view of FIG. 2A, further illustrating an embodiment of an electrical connection comprising one or more fibers. [Figure 3A] 1 depicts a substrate supporting a plurality of electronic components and a plurality of electrical connections electrically connecting one or more of the electronic components. [Figure 3B] 1 depicts a substrate supporting a plurality of electronic components and a plurality of electrical connections electrically connecting one or more of the electronic components. [Figure 3C] 1 depicts a substrate supporting a plurality of electronic components and a plurality of electrical connections electrically connecting one or more of the electronic components. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The embodiments disclosed herein relate to devices and methods for at least one of monitoring or treating biological tissue using a sensor-enabled substrate. The systems and methods disclosed herein are not limited to treating or monitoring a particular type of tissue or injury, but instead, the sensor-enabled technology disclosed herein is broadly applicable to any type of therapy that can benefit from a sensor-enabled substrate. Some implementations utilize sensors and data collection that are trusted by medical practitioners to make both diagnostic and patient management decisions.

[0015] Some systems and methods disclosed herein relate to the use of sensors mounted on or embedded within a substrate configured for use in the treatment of both intact and damaged human or animal tissue. Such sensors may collect information about the surrounding tissue and transmit such information to a computing device or caregiver for use in further treatment. In certain cases, such sensors may be attached to the skin anywhere on the body, including areas for monitoring arthritis, temperature, or other areas prone to problems and requiring monitoring. The sensors disclosed herein may also incorporate markers, such as radiopaque markers, to indicate the presence of the device, for example, prior to performing an MRI or other technique.

[0016] The sensor system and method disclosed herein may be used in combination with clothing. Non-limiting examples of clothing for use with the sensor system and method disclosed herein include shirts, pants, trousers, dresses, underwear, outerwear, gloves, shoes, hats, and other suitable clothing. In certain cases, the sensor system and method disclosed herein may be welded or laminated to a particular garment. The sensor system and method may be printed directly on the garment and / or embedded in the fabric. Breathable and printable materials such as microporous membranes may also be suitable.

[0017] The sensor systems and methods disclosed herein may be incorporated into cushioning or bed pads, such as in hospital beds, to monitor patient characteristics, such as any of the characteristics disclosed herein. In certain cases, disposable films containing such sensors may be placed over hospital beds and removed / replaced as needed.

[0018] In some implementations, the sensor systems and methods disclosed herein may incorporate energy harvesting such that the sensor systems and methods are self-sustaining. For example, energy may be harvested from a thermal energy source, a kinetic energy source, a chemical gradient, or any suitable energy source.

[0019] The sensor systems and methods disclosed herein may be utilized in rehabilitation devices and treatments, including sports medicine. For example, the sensor systems and methods disclosed herein may be used in braces, sleeves, wraps, supports, and other suitable items. Similarly, the sensor systems and methods disclosed herein may be incorporated into sports equipment, such as helmets, sleeves, and / or pads. For example, such sensor systems and methods may be incorporated into protective helmets to monitor characteristics, such as acceleration, that may be useful in concussion diagnosis.

[0020] The sensor systems and methods disclosed herein may be used in conjunction with surgical devices, such as the NAVIO Surgical System by Smith & Nephew Inc. In some embodiments, the sensor systems and methods disclosed herein may communicate with such surgical devices to guide placement of the surgical device. In some embodiments, the sensor systems and methods disclosed herein may monitor blood flow to or away from a potential surgical site, or confirm the absence of blood flow to a surgical site. Additional surgical data may be collected to assist in preventing scarring and monitor areas away from the affected area.

[0021] To further aid surgical techniques, the sensors disclosed herein may be incorporated into surgical drapes to provide information about tissues beneath the drape that may not be immediately visible to the naked eye. For example, a sensor-embedded flexible drape may have sensors strategically positioned to provide improved area-focused data collection. In certain embodiments, the sensor systems and methods disclosed herein may be incorporated into the boundaries or interior of the drape to create fencing that limits / controls the surgical theater.

[0022] The sensor systems and methods disclosed herein may also be utilized for pre-operative evaluation. For example, such sensor systems and methods may be used to gather information about potential surgical sites, such as by monitoring the skin and underlying tissue for potential incision sites. For example, perfusion levels or other suitable characteristics may be monitored at the surface of the skin and deeper in the tissue to assess whether an individual patient may be at risk for surgical complications. Sensor systems and methods such as those disclosed herein may be used to assess the presence of microbial infection and provide indications for the use of antimicrobial agents. Additionally, the sensor systems and methods disclosed herein may gather additional information at deeper tissues, such as identifying pressure ulcer lesions and / or adipose tissue levels.

[0023] The sensor embodiments disclosed herein may be utilized for cardiovascular monitoring. For example, such sensor systems and methods may be incorporated into a flexible cardiovascular monitor that may be placed against the skin to monitor characteristics of the cardiovascular system and communicate such information to another device and / or a caregiver. For example, such devices may monitor pulse rate, blood oxygenation, and / or cardiac electrical activity. Similarly, the sensor systems and methods disclosed herein may be utilized for neurophysiological applications, such as monitoring electrical activity of neurons.

[0024] The sensor systems and methods disclosed herein may be incorporated into implantable devices, such as implantable orthopedic implants, including flexible implants. Such sensor systems and methods may be configured to collect information about the implant site and transmit this information to an external source. In some cases, an internal source may also provide power to such implants.

[0025] The sensor systems and methods disclosed herein may also be utilized to monitor biochemical activity at or below the surface of the skin, such as lactose accumulation in muscle or sweat rate on the surface of the skin. In some cases, other properties may be monitored, such as glucose concentration, urine concentration, tissue pressure, skin temperature, skin surface conductivity, skin surface resistivity, skin hydration, skin maceration, and / or skin tearing.

[0026] The sensor systems and methods disclosed herein may be incorporated into ear, nose, and throat (ENT) applications. For example, such sensor systems and methods may be utilized to monitor recovery from ENT-related procedures, such as wound monitoring in the sinus passages.

[0027] The sensor systems and methods disclosed herein may include sensor printing techniques involving encapsulation, such as encapsulation with a polymeric film. Such films may be constructed using any of the polymers described herein, such as polyurethane. The encapsulation may provide waterproofing of the electronics, as well as protection from local tissue, local fluids, and other sources of potential damage.

[0028] In certain cases, the sensors disclosed herein may be incorporated into an organ protection layer. Such a sensor-embedded organ protection layer may both protect the organ of interest and ensure that the organ protection layer is in place and provides protection. Additionally, the sensor-embedded organ protection layer may be utilized to monitor the underlying organ, such as by monitoring blood flow, oxygenation, and other suitable markers of organ health. In some cases, the sensor-enabled organ protection layer may be used to monitor a transplanted organ, such as by monitoring the fat and muscle content of the organ. Additionally, the sensor-enabled organ protection layer may be used to monitor the organ during transplantation and after transplantation, such as during organ rehabilitation.

[0029] The sensor systems and methods disclosed herein may be incorporated into the treatment of wounds (disclosed in more detail below) or a variety of other applications. Non-limiting examples of additional applications for the sensor systems and methods disclosed herein include monitoring and treatment of intact skin, cardiovascular applications such as monitoring blood flow, orthopedic applications such as monitoring limb movement and bone repair, neurophysiological applications such as monitoring electrical impulses, and any other tissue, organ, system, or condition that can benefit from improved sensor-enabled monitoring.

[0030] wound therapy Some systems and methods disclosed herein relate to wound therapy for a human or animal body. Thus, any reference to a wound herein may refer to a wound on a human or animal body, and any reference to a body herein may refer to a human or animal body. The disclosed systems and methods may relate to preventing or minimizing damage to physiological or biological tissues or treating damaged tissues (e.g., wounds as described herein) with or without reduced pressure, including, for example, negative pressure sources and wound dressing components and devices. The devices and components, including wound overlay and packing materials, or inner layers, if present, are sometimes collectively referred to as dressings. In some cases, wound dressings may be provided to be utilized without reduced pressure.

[0031] As used herein, the term "wound" may include injuries to living tissue that may be caused by a cut, blow, or other impact, typically an impact in which the skin is cut or broken. Wounds may be chronic or acute injuries. Acute wounds occur as a result of surgery or trauma. They progress through the stages of healing within a predictable time frame. Chronic wounds typically begin as acute wounds. Acute wounds may become chronic wounds when they do not follow the healing stages, resulting in prolonged recovery. It is believed that the transition from acute to chronic wounds may be due to the patient being immunocompromised.

[0032] Chronic wounds may include, for example, venous ulcers (such as those occurring in the legs), which account for the majority of chronic wounds and primarily affect the elderly, diabetic ulcers (e.g., foot or ankle ulcers), peripheral arterial disease, pressure ulcers, or epidermolysis bullosa (EB).

[0033] Examples of other wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sternotomy, fasciotomy, or other conditions, dehiscence wounds, acute wounds, chronic wounds, subacute wounds and dehiscence wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers.

[0034] Wounds may also include deep tissue injury, a term proposed by the National Pressure Ulcer Advisory Panel (NPUAP) to describe a specific form of pressure ulcer. These ulcers have been described by clinicians for many years with terms such as purple pressure ulcer, aggravating ulcer, and bruises on bony prominences.

[0035] Wounds may also include tissues at risk of becoming wounds, as discussed herein. For example, tissues at risk may include tissues over bony prominences (at risk of deep tissue injury / damage) or pre-surgical tissues (e.g., knee tissues) that may have the potential to be amputated (e.g., joint replacement / surgical alteration / reconstruction).

[0036] Some disclosures relate to methods of treating wounds using the techniques disclosed herein in combination with one or more of the following: advanced footwear, turning the patient, offloading (e.g., offloading diabetic foot ulcers), treatment of infection, systemics, antimicrobials, antibiotics, surgery, removal of tissue, influencing blood flow, physical therapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, active ozone, antibiotics, antimicrobials, and the like.

[0037] Alternatively or additionally, wounds may be treated using traditional advanced wound care that is not assisted by the use of topical negative pressure (TNP) and / or applied negative pressure (which may also be referred to as non-negative pressure therapy).

[0038] Advanced wound care may include the use of absorbent dressings, occlusive dressings, the use of antimicrobial and / or debridement agents in wound dressings or supports, the use of pads (e.g., cushioning or compression therapy such as stockings or bandages), and the like.

[0039] In some cases, the wound dressing includes one or more absorbent layers, which may be foam or superabsorbent.

[0040] In some cases, the disclosed technology may be used with non-negative pressure dressings. A non-negative pressure wound dressing suitable for providing protection at a wound site may include an absorbent layer for absorbing wound exudate and a shielding element for at least partially shielding the view of the wound exudate absorbed by the absorbent layer during use. The shielding element may be partially translucent. The shielding element may be a masking layer.

[0041] In some cases, the non-negative pressure wound dressings disclosed herein include a wound contact layer, and the absorbent layer overlies the wound contact layer. The wound contact layer may carry an adhesive portion for forming a substantially fluid-tight seal on the wound.

[0042] In some cases, the wound dressings disclosed herein further comprise a layer of superabsorbent fibers, or viscose or polyester fibers.

[0043] In some cases, the wound dressing disclosed herein further comprises a backing layer. The backing layer may be a transparent or opaque film. Typically, the backing layer comprises a polyurethane film (typically a transparent polyurethane film).

[0044] In some cases, the foam may be an open cell foam or a closed cell foam, typically an open cell foam. The foam may be hydrophilic.

[0045] The wound dressing may comprise a transmission layer, which may be a foam. The transmission layer may be a polyurethane foam laminated to a polyurethane film.

[0046] The non-negative pressure wound dressing may be a compression bandage. Compression bandages are known for use in treating edema and other venous and lymphatic diseases, such as in the lower extremities. The compression bandage may comprise a dressing system including an endothelial-facing layer and an elastic outer layer, the inner layer comprising a first ply of foam and a second ply of absorbent nonwoven web, the inner and outer layers being sufficiently elongated to be wrapped around the patient's limb.

[0047] Negative Pressure Wound Therapy In some cases, the treatment of wounds may be performed using negative pressure wound therapy. It will be understood that the systems and methods of the present disclosure may generally be applicable for use with TNP systems. In brief, negative pressure wound therapy may assist in the closure and healing of many forms of "difficult to heal" wounds by reducing tissue edema, promoting blood flow and granular tissue formation, and removing excessive exudate, and may reduce bacterial load (and therefore infection risk). In addition, the therapy may reduce wound unrest, leading to faster healing. TNP therapy systems may also assist in the healing of surgically closed wounds by helping to remove fluid and stabilize tissue in an apposed position of closure. Further beneficial uses of TNP therapy may be found in grafts and flaps, where it is important to remove excess fluid and where grafts are required to be in close proximity to tissue to ensure tissue viability.

[0048] Negative pressure therapy can be used to treat open or chronic wounds that are too large to close naturally or that otherwise do not heal with the application of negative pressure to the wound site. A typical negative pressure (TNP) therapy or negative pressure wound therapy (NPWT) system involves placing a fluid-impermeable or semi-permeable covering over the wound, using various means to seal the covering against the patient's tissue surrounding the wound, and connecting a negative pressure source (such as a vacuum pump) to the covering in such a manner that a negative pressure is created and maintained beneath the covering. Such negative pressure is believed to promote wound healing by simultaneously facilitating the formation of granulation tissue at the wound site and supporting normal internal inflammatory processes while removing excess fluid, which may contain harmful cytokines or bacteria.

[0049] Some of the dressings used for NPWT can include many different types of materials and layers, such as gauze, pads, foam pads, or multi-layer wound dressings. One example of a multi-layer wound dressing is the PICO dressing available from Smith & Nephew, which includes a wound contact layer and a superabsorbent layer below a backing layer to provide a canister-free system for treating wounds with NPWT. The wound dressing may be sealed with a suction port that provides a connection to a long tube that may be used to pump fluid from the dressing or transfer negative pressure from a pump to the wound dressing. In addition, RENASYS-F, RENASYS-G, RENASYS-AB, and RENASYS-F / AB available from Smith & Nephew are further examples of NPWT wound dressings and systems. Another example of a multi-layer wound dressing is the ALLEVYN Life dressing available from Smith & Nephew, which includes a moist wound environment dressing used to treat wounds without the use of negative pressure.

[0050] As used herein, a reduced pressure or negative pressure level, such as -XmmHg, represents a pressure level relative to normal ambient air pressure, which may correspond to 760mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Thus, a negative pressure value of -XmmHg reflects an absolute pressure of XmmHg less than 760mmHg, or in other words, an absolute pressure of (760-X)mmHg. In addition, a negative pressure "lower" or "smaller" than XmmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40mmHg is lower than -60mmHg). A negative pressure "higher" or "larger" than -XmmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80mmHg is higher than -60mmHg). In some cases, the local ambient air pressure is used as a reference point, and such local air pressure may not necessarily be, for example, 760mmHg.

[0051] In some wound closure devices described herein, increased wound contraction can lead to increased tissue expansion in the surrounding wound tissue. This effect can be increased by varying the force applied to the tissue, for example, varying the negative pressure applied to the wound over time, possibly in conjunction with increased tension applied to the wound by some of the wound closure devices. In some cases, the negative pressure can be varied over time, for example, using a sine wave, a square wave, or in synchronization with one or more physiological indicators (such as heart rate).

[0052] Any of the systems and methods disclosed herein may be modified in any manner in accordance with any of the following patents: WO2010 / 061225, US2016 / 114074, US2006 / 0142560, and US5,703,225, which describe absorbent materials; WO2013 / 007973, which describes non-negative pressure wound dressings; GB1618298.2 (filed October 28, 2016), GB1621057.7 (filed December 12, 2016), and GB1709987.0 (filed June 22, 2017), which describe multi-layer wound dressings; EP2498829 and EP171825, which describe wound dressings; 7, which describe compression bandages, US 8,235,955 and US 7,753,894 which describe wound closure devices, and WO 2013 / 175306, WO 2016 / 174048, US 2015 / 0190286, US 2011 / 0282309, and US 2016 / 0339158 which describe negative pressure wound therapy dressings, wound dressing components, wound treatment apparatus, and methods, the disclosures of each of which are incorporated herein by reference in their entirety.

[0053] Sensor-Enabled Wound Monitoring and Therapy System FIG. 1A illustrates a wound monitoring and therapy system 10. The system includes a sensor-enabled wound dressing 22 connected to a control module 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 disposed within the dressing 22 to collect measurement data from one or more of the wound or areas surrounding the wound, such as the wound periphery (which may include unbroken skin). The control module 24 may receive, store, and process data collected 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 control module 24 may transmit one or more commands and data to the dressing 22.

[0054] The wound dressing 22 may be disposable and the control module 24 may be reusable. In some cases, the wound dressing 22 may be reusable. In some cases, the control module 24 may be a controller. In some cases, the wound dressing 22 may be resterilized or otherwise disinfected or sterilized. In some cases, the control module 24 may be disposable. In some cases, the wound dressing 22 and the control module 24 may be permanently connected and the combined wound dressing and control module may be disposable or reusable or resterilized or otherwise disinfected or sterilized. The control module 24 may be located on the wound dressing 22. The control module 24 may be spatially separated from the wound dressing 22, such as by a cable or another wired or wireless electrical connection. The control module 24 may include a power source (such as a battery), one or more processors, one or more data storage elements, and a communication device. In some cases, the control module 24 may include one or more sensors, such as a temperature sensor or a light (or optical) sensor, to gather information about patient or environmental conditions located remotely from the wound dressing 22. In some cases, the one or more sensors of the control module 24 may include an accelerometer, a motion sensor, or a gyroscope.

[0055] The wound dressing 22 may include one or more indicators for communicating information to the user. The indicators may be visual, audible, tactile, or tactile. The communicated information may include measurement data, wound status, etc.

[0056] The control module 24 can communicate data to the communication device 30, such as when requested, periodically, or the like. When the communication device is placed in communication range, the communication can occur via a wired or wireless interface, such as via near field communication (NFC), RFID, or the like. For example, the communication range may be close, such as within a range of approximately 3 cm or less or more, to the control module 24. The communication device 30 can be placed in communication range by a clinician, such as during initialization and at the end of treatment. The control module 24 can respond with data to commands from the communication device 30 requesting the data. The communication can be performed via transfer of hardware or data storage, such as one or more memory storage devices (e.g., SD cards). In some cases, the communication can be performed non-electronically, such as visually, audibly, or tactilely, and one or more of the control module 24 or the communication device 30 can provide an interface for such non-electronic communication of data.

[0057] The communication device 30 may be connected to a computing device 40, such as, for example, a personal computer, tablet, smartphone, etc., via a wired or wireless interface. For example, a wired USB protocol may be used for communication of data between the devices 30 and 40. As another example, the communication of data may be implemented via transfer of hardware or data storage devices, such as one or more memory storage devices (e.g., SD cards). In some cases, the communication of data may be implemented non-electronically, such as visually, audibly, or tactilely, and one or more of the communication device 30 or computing device 40 may provide an interface for such non-electronic communication of data.

[0058] The computing device 40 can further process the data collected by the dressing 22. For example, the computing device 40 can aggregate data collected from the dressing 22 and a perfusion determination device 70, which is configured to determine skin perfusion pressure and communicate 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 the device 70 and the device 40.

[0059] The computing device 40 may be configured to communicate via a wired or wireless interface with a remote computing device 50 that stores and processes the medical data. In some cases, the remote computing device 50 may be a cloud computing device including one or more of a remote storage, server, processing device, or any means of information storage. For example, the remote computing device 50 may process and store the medical data in accordance with one or more applicable security and privacy standards, such as the Health Insurance Portability & Accountability Act (HIPAA), the European Union Directive on Data Protection, etc. The remote computing device 50 may make available data provided by one or more of the computing device 40 or the mobile device 60 for remote access and display, such as, for example, on a mobile device 60. In certain implementations, additional data may be added for storage on the remote computing device 50. For example, the additional data may be added by the mobile device 60 via a dedicated app, a web browser interface, or the like. The remote computing device 50 may process data from one or more of the wound dressing 22, the perfusion determination device 70, or the mobile device to evaluate or determine a treatment plan, such as suggesting or adjusting one or more therapeutic therapies.

[0060] As described herein, the mobile device 60 can take one or more images of the patient's wound. Such data can be transmitted to the remote computing device 50 via a wired or wireless interface. Although a smartphone is illustrated, the mobile device 60 can be any suitable computing device that includes imaging capabilities, such as a camera. The mobile device 60 can also collect additional data, such as data entered by a medical professional in response to a questionnaire.

[0061] Sensor-enabled substrates and wound dressings Wound dressings incorporating several electronic components, including one or more sensors, can be utilized to monitor wound characteristics. Collecting and analyzing data from a wound can provide useful insight into determining whether the wound is on a healing curve, selecting appropriate therapy, determining whether the wound has healed, etc.

[0062] In some embodiments, some sensor technologies may be used in one or more components that form part of the wound dressing or the entire wound dressing device. For example, as illustrated in FIG. 1B, FIG. 1C, one or more sensors may be incorporated on or in a substrate (such a substrate may be referred to as a "sensor-integrated substrate" or a "sensor-enabled substrate"). Although the substrate is illustrated as having a square shape, it will be understood that the substrate may have other shapes, such as a rectangular, circular, oval, etc. In some cases, the substrate supporting one or more sensors may be provided as an individual layer of material that is placed directly or indirectly on or in the wound. The sensor-integrated substrate may be part of a larger wound dressing device. In some cases, the sensor-integrated substrate is part of a single unit dressing. Additionally or alternatively, the sensor-integrated substrate may be placed directly or indirectly on or in the wound and then covered by a secondary wound dressing which may include one or more of gauze, foam, or other wound packing material, a superabsorbent layer, a drape, a fully integrated dressing such as the Pico or Allevyn Life dressings manufactured by Smith & Nephew, and the like.

[0063] The sensor-integrated substrate may be placed in contact with the wound and allow fluid to pass through the substrate without causing any or little damage to the tissue in the wound. The substrate may be flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover the wound. For example, the substrate may be made of a stretchable or substantially stretchable material, such as polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene tetraphthalate (PET), polybutarene tetraphthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), and one or more of various fluoropolymer (FEP) and copolymer materials, or another suitable material.

[0064] A stretchable or substantially stretchable material may be stretched up to or more than 5%, up to or more than 10%, up to or more than 20%, or more than 20% of its starting dimension, such as length or width. In some cases, a stretchable or substantially stretchable material can return to within 5% or more of its starting dimension (such as length or width) after being stretched.

[0065] In some cases, the substrate may include one or more flexible circuit substrates, which may be formed of flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymers (FEP) and copolymers, etc. One or more sensors may be incorporated into the two-layer flexible circuit. In some scenarios, the one or more circuit substrates may be multi-layer flexible circuit substrates.

[0066] In some cases, the sensor integrated substrate may incorporate an adhesive that adheres to wet or dry tissue. In some cases, one or more sensors, on which one or more flexible circuits may be positioned, may be incorporated into any layer of the wound dressing. For example, the wound contact layer may have a cutout or slit that allows one or more sensors to protrude from the lower surface of the wound contact layer and directly contact the wound. In some situations, one or more sensors may be incorporated into or encapsulated in other components of the wound dressing, such as, for example, the absorbent layer.

[0067] As shown in FIG. 1B, the sensor-integrated substrate 100B may support a number of electronic components and a number of electrical connections interconnecting at least some of the components. The electronic components may be one or more of any electronic components described herein, such as sensors, amplifiers, capacitors, resistors, inductors, controllers, processors, diodes, etc. The electrical connections may electrically connect one or more of the electronic components. The electrical connections may be traces or tracks printed on the substrate using, for example, copper, conductive inks (such as inks including any one or any combination of silver, graphite, carbon, graphene, graphene oxide, carbon nanotubes, nanosilver), nanotechnology-based conductive inks, organic conductive inks, etc. At least some of the electronic connections may be flexible or stretchable, or substantially flexible or stretchable.

[0068] The electronic components may include one or more impedance or conductivity sensors 110, which may be arranged in an outer 4×4 grid and an inner 4×4 grid as illustrated in FIG. 1B, FIG. 1C. The sensors 110 are illustrated as pads configured to measure tissue impedance or conductivity across any pair of pads. Two (or more) excitation pads 115 may be arranged as illustrated to provide an excitation signal across the pads, which is conducted by the tissue, and in response, tissue impedance or conductance may be measured across the pads 110. Electronic components such as one or more amplifiers 120 may be used to measure tissue impedance or conductance. Impedance or conductance measurements may be used to distinguish between live and dead tissue, monitor healing progress, and the like. Arrangement of the pads 110 in the inner and outer grids may be used to measure wound impedance or conductance, wound circumference, or tissue or area surrounding the wound.

[0069] The electronic components may include one or more temperature sensors 130 configured to measure the temperature of the wound or surrounding tissue. For example, nine temperature sensors were positioned around the periphery of the substrate 100B. The one or more temperature sensors may include one or more thermocouples or thermostats. The one or more temperature sensors may be calibrated and data obtained from the one or more sensors may be processed to provide information about the wound environment. In some cases, an ambient sensor measuring ambient air temperature may be used to help eliminate problems associated with environmental temperature shifts.

[0070] The electronic components may include one or more optical sensors 150. The one or more optical sensors 150 may be configured to measure the appearance of the wound or image the wound. In some cases, a light source or illumination source that emits light and a light sensor or detector that detects the light reflected by the wound are used as the one or more optical sensors. The light source may be a light emitting diode (LED), such as one or more white LEDs, red, green, blue (RGB) LEDs, ultraviolet (UV) LEDs, etc. The light sensor may be one or more of an RGB sensor configured to detect color, an infrared (IR) color sensor, a UV sensor, etc. In some cases, both the light source and the detector will be pressed against the skin, which will cause the light to penetrate into the tissue and exhibit the spectral characteristics of the tissue itself. In some scenarios, the one or more optical sensors may include an imaging device, such as a charge-coupled device (CCD), a CMOS image sensor, etc.

[0071] In some cases, ultra-bright LEDs, RGB sensors, and polyester optical filters may be used as components of one or more optical sensors to measure through tissue color differentiation. For example, color may be measured from light that first passes through tissue for a given geometry, as surface color may be measured from reflected light. This may include color sensing from diffuse light diffused from an LED in contact with the skin, etc. In some cases, an LED may be used with a proximal RGB sensor to detect light diffused through tissue. The optical sensor may image using diffuse internal light or surface reflected light.

[0072] One or more of the electronic components may be controlled by a control module. The control module may receive and process one or more measurements taken by one or more sensors. An external control module, such as 24 illustrated in FIG. 1A, may be connected to at least some of the electronic components via a connector (e.g., connector 140 in FIG. 1B, FIG. 1C). In some cases, the connector 140 may be positioned at the end of the conductive track portion as illustrated in FIG. 1C, or attached to the conductive track portion at a location away from the end as illustrated in FIG. 1B (e.g., attached to the top of the track portion with an adhesive). The control module may include one or more controllers or microprocessors, memory, etc. In some cases, the one or more controllers may be located on the substrate, and the connector 140 is not used. In some cases, data and commands may be communicated wirelessly, such as by a transceiver located on the substrate, and the connector 140 is not used.

[0073] In some cases, additional or alternative sensors, such as one or more pH sensors, pressure sensors, irrigation sensors, etc., may be positioned on the substrate.

[0074] In some cases, the substrate may be perforated as illustrated in FIG. 1C. A plurality of perforations 160 may be formed in the substrate 100C to allow fluid to pass through the substrate. It may be advantageous to use the perforated substrate in conjunction with the application of negative pressure wound therapy, during which reduced pressure is applied to a wound covered by the dressing to cause removal of fluid (such as wound exudate) from the wound. The perforations 160 may be formed around a plurality of electronic components and connections as illustrated in FIG. 1B and FIG. 1C. The perforations 160 may be formed as slits or holes. In some cases, the perforations 160 may be small enough to help prevent tissue ingrowth while allowing fluid to pass through the substrate.

[0075] In some cases, the substrate may be coated to encapsulate or cover one or more of the substrate or components supported by the substrate. The coating may provide biocompatibility, shield or protect electronic circuitry from contact with liquids, provide padding for electronic components to increase patient comfort, etc. Such coatings may also be referred to as "conformal coats" or "soft coats." Soft coats may be stretchable or substantially stretchable. Soft coats may be hydrophobic or substantially hydrophobic.

[0076] The soft coat may be formed from one or more suitable polymers, adhesives such as 1072-M adhesive (e.g., Dymax 1072-M), 1165-M adhesive (e.g., Dymax 1165-M, etc.), parylene (e.g., Parylene C, etc.), silicones, epoxies, urethanes, acrylated urethanes, acrylated urethane substitutes (e.g., Henkel Loctite 3381, etc.), or other suitable biocompatible and substantially elastic materials. The soft coat may be a thin coating, for example, from about 80 microns or less to several millimeters or more. The soft coat may have a hardness less than about A100, A80, A50 or less. The soft coat may have an elongation at break of greater than about 100%, 200%, 300%, or more. The soft coat may have a viscosity of about 8,000 to 14,500 centipoise (cP). In some cases, the coating may have a viscosity of about 3,000 cP or more. In some cases, the coating may have a viscosity of less than about 3,000 cP.

[0077] In some cases, it may be desirable for the substrate to be stretchable or substantially stretchable to better conform to or cover the wound, but at least some of the electronic components or connections may not be stretchable or flexible. In such cases, when the substrate is positioned in or on the wound, undesirable or excessive local strain or stress may be exerted on one or more electronic components, such as the support area or mounting of the electronic components. For example, such stress may result from patient movement, changes in the shape or size of the wound (e.g., due to its healing), etc. Such stress may cause one or more electronic components or connections to move, fall off, or malfunction (e.g., creating an open circuit from a pin or another connector that is disconnected). Alternatively or additionally, it may be desirable to maintain the position of one or more electronic components, such as one or more sensors, in the same or substantially the same location or area relative to the wound (e.g., in contact with the wound) so that measurements collected by the one or more electronic components accurately capture changes over time in the same or substantially the same location or area of ​​the wound. The surface of the stretchable substrate may move, for example, when the patient moves, yet it may be desirable to maintain the same or substantially the same position of one or more electronic components relative to the wound.

[0078] To address these issues, in some cases, a non-stretchable or substantially non-stretchable coating (such a coating may also be referred to as a "hard coat") may be applied to one or more electronic components, one or more electrical connections, or the like. The hard coat may provide one or more of reinforcement or stress relief for one or more electronic components, one or more electrical connections, or the like. The hard coat may be formed from an acrylated or modified urethane material. For example, the hard coat may be one or more of Dymax 1901-M, Dymax 9001-E, Dymax 20351, Dymax 20558, Henkel Loctite 3211, or another suitable material. The hard coat may have a viscosity of about 13,500 cP to 50,000 cP before curing, or a viscosity of about 3,600 cP to about 6,600 cP before curing. In some cases, the hard coat may have a viscosity of about 50,000 cP or less. The hard coat may have a hardness of about D40 to about D65 and / or a linear shrinkage of about 1.5 to 2.5%.

[0079] Any of the hard or soft coats described herein may be applied by one or more of lamination, adhesion, welding (e.g., ultrasonic welding), curing by one or more of light, UV, heat (e.g., heating), and the like. Any of the hard or soft coats described herein may be transparent or substantially transparent to facilitate the transmission of light through the coating, such as for light sensing. Any of the coatings described herein may retain adhesive strength when subjected to sterilization, such as EtO sterilization. Any of the coatings described herein may be modified to fluoresce, such as under UV light.

[0080] In some implementations, the borders or edges of the substrate may be smoothed by cutting, may have a smooth contour, may include fibers, etc. to improve patient comfort.

[0081] In some cases, the substrate 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 substrate. The one or more antennas may be used to communicate measurement data collected by one or more sensors without the use of a controller such as the control module 24. The one or more antennas may additionally be used to wirelessly receive power from a power source. In certain 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 substrate is under stress in use on a patient. Fixing the one or more resonant frequencies may be advantageous for certain communication protocols, such as RFID.

[0082] Any of the systems and methods disclosed herein may be used in combination with any of the features disclosed in one or more of GB Application No. 1905696.9, entitled "Sensor Integrated Dressings And Systems," filed April 24, 2019, which describes various dressings and components thereof, and GB Application No. 1905696.9, entitled "Sensor Integrated Dressings And Systems," filed January 20, 2019, which describes various dressings and components thereof, the disclosures of each of which are incorporated herein by reference in their entirety.

[0083] Electrical connections on the substrate 2A illustrates a cross-sectional view of a portion of an example wound monitoring and / or therapy device 200 including an electronic component 204 electrically coupled to a substrate 202 via a solder paste 208 and a number of electrical connections 210. It will be understood that the wound monitoring and / or therapy device 200 may include fewer or more components, as desired. For example, the substrate 202 may be electrically coupled to one or more different or additional electronic components via the same or other electrical connections. Additionally, in some cases, the electronic component 204 may be directly coupled to the electrical connections 210, rather than indirectly coupled to the electrical connections 210 via, for example, the solder paste 208.

[0084] The electronic component 204 may be the same as or similar to any electronic component described herein, such as, for example, a sensor, an amplifier, a capacitor, a resistor, an inductor, a controller, a processor, a diode, a connector, etc. As shown, the electronic component 204 may include multiple electrical connectors 206. For example, the electronic component 204 may include one or more electrical connectors 206 for power, ground, input, output, data, etc. In some cases, the electrical connectors 206 include one or more of an electrical pad, a pin, or a tab. The electrical connectors 206 may be utilized to electrically connect the electronic component 204 to one or more other electronic components, such as traces or tracks printed on the substrate 202, or to one or more electrical connections 210.

[0085] The substrate 202 may be the same or similar to any combination of one or more of the substrates described herein. For example, the substrate 202 may include any combination of one or more features or characteristics of the sensor-integrated substrate 100B of FIG. 1B or the sensor-integrated substrate 100C of FIG. 1C. For example, in some cases, the substrate 202 is flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover a wound. In some cases, it may be advantageous to utilize electrical connections 210 that can be stretched. In some cases, areas of the substrate 202 that include the electronic components 204 may be less rigid or flexible than other areas of the substrate 202. In some cases, the substrate 202 may include one or more fibers, such as cotton or other woven fibers.

[0086] The electrical connections 210 may be printed on or integrated with the substrate 202. For example, the electrical connections 210 may be screen printed onto the substrate. In some cases, the electrical connections 210 allow various electrical signals, connections, and / or power to be routed on, off, or through the substrate 202. For example, one or more combinations of the electrical connections 210 may electrically connect various points of the substrate 202 and / or electrically connect various electronic components located on or off the substrate 202.

[0087] In some cases, one or more of the electrical connections 210 include traces or tracks printed on the substrate 202. For example, the electrical connections 210 may include one or more combinations of copper, conductive ink (e.g., inks including one or more of silver, graphite, carbon, graphene, graphene oxide, carbon nanotubes, nanosilver), nanotechnology-based conductive inks, organic conductive inks, etc., conductive glue, conductive tape, fibers, solder paste, or the like. As described herein, in some cases, the electrical connections 210 may include one or more types of conductive ink, conductive glue, conductive tape, fibers, solder paste, or the like. For example, a first type of conductive ink may be applied at a first location on the substrate 202 and a second type of conductive ink may be applied at a second location on the substrate 202. In some such examples, the use or placement of the different types of conductive inks may be based at least in part on one or more features or characteristics of the conductive inks. For example, a more conductive ink may be utilized in a region or area for soldering, and a different ink (e.g., an ink whose resistance does not change dramatically when the ink is drawn down) may be utilized in one or more other areas on the substrate 202. In this manner, the wound monitoring and / or therapy device 200 may utilize the benefits of multiple conductive inks. As another example, a more conductive ink, or an ink with a smaller impedance, may be utilized for communication signals, such as antenna traces.

[0088] In some cases, one or more of the portions of the solder paste 208 can be printed onto the electrical connections 210 or the substrate 202. For example, the solder paste 208 can be printed onto the electrical connections 210 and / or the substrate 202 and then heated (along with the rest of the board) to melt the solder paste 208 and form a mechanical bond and electrical connection. In some cases, the solder paste 208 is replaced with a different material, such as conductive glue or tape. In some cases, the wound monitoring and / or therapy device 200 does not include the solder paste 208. For example, in some cases, the electronic component 204 can be directly coupled to the electrical connections 210 rather than indirectly coupled to the electrical connections 210 via the solder paste 208.

[0089] Multiple Conductive Inks Different types of conductive inks may have different properties and / or characteristics. For example, impedance, variance of impedance (e.g., due to ink stretching), thermal conductivity, electrical conductivity, etc. may vary based on the type of ink used. As will follow, some inks may be better for some purposes and other inks better for other purposes. Thus, in some cases, the wound monitoring and / or therapy device 200 may utilize an electrical connection 210 that includes multiple types of conductive inks. Further, in some cases, a particular type of conductive ink may be disposed on the substrate 202 based on its advantageous properties. Thus, in some implementations, two or more different types of conductive inks may be disposed (or bonded) on the substrate 202, for example, to take advantage of beneficial properties of the different types of conductive inks. However, it will be understood that in some cases, one or more types of conductive inks may be disposed on the substrate 202 without consideration or contrary to one or more of its properties (e.g., thermal conductivity, electrical conductivity, impedance, flexibility, etc.).

[0090] Similar to FIG. 2A, FIG. 2B illustrates a cross-sectional view of a portion of an exemplary wound monitoring and / or therapy device 250 including an electronic component 204 electrically coupled to a substrate 202 via a solder paste 208 and a plurality of electrical connections 210. FIG. 2B further illustrates an example of the electrical connections 210 including a plurality of types of conductive inks. Specifically, the electrical connections 210 include a first type of conductive ink 212 (sometimes referred to herein as first ink 212) and a second type of conductive ink 214 (sometimes referred to herein as second ink 214). Although FIG. 2B is discussed with respect to conductive inks, it will be understood that the electrical connections 210 may additionally or alternatively include one or more metals, conductive glues, conductive tapes, fibers, fluorescent elements, or the like. Additionally, while only two types of conductive inks are shown, it will be understood that additional or different types of conductive inks may be used.

[0091] In some cases, the first ink 212 and the second ink 214 have one or more different characteristics, such as different thermal conductivity, electrical conductivity, impedance, flexibility, or the like. For example, in some cases, the first ink 212 and the second ink 214 have different electrical conductivity. For example, an ink with a relatively higher electrical conductivity may enable thinner traces and / or improved electrical connections. Thus, in some cases, the ink 212 or 214 with higher electrical conductivity may be utilized in areas for various connections, such as contact areas of the electronic component 204 (e.g., areas where the electronic component 204 is connected to a substrate) and / or ink footprints around the electronic component 204. Additionally, in some cases, the ink 212 or 214 with higher electrical conductivity may be utilized to attach the electronic component 204 to the substrate 202. Additionally, in some cases, the ink 212 or 214 with higher electrical conductivity may be utilized for communication signals, such as antenna traces. 2B , the first ink 212 is utilized to mount the electronic component 204. Thus, in some cases, the first ink 212 is more conductive than the second ink 214. However, in some cases, the second ink 214 is more conductive than the first ink 212, or the first ink 212 and the second ink 214 have approximately equal conductivity. In some cases, one ink is more conductive than the other ink at least because it contains more or a particular metal (e.g., silver), is thicker, or is wider.

[0092] In some cases, the first ink 212 and the second ink 214 have different thermal conductivities. For example, in some cases, the first ink 212 has a higher thermal conductivity than the second ink 214, while in other cases, the second ink 214 has a higher thermal conductivity than the first ink 214.

[0093] In some cases, the first ink 212 and the second ink 214 adhere, bond, or join differently than the solder paste 208. For example, in some cases, the first ink 212 makes a good electrical connection with the solder paste 208 and the second ink 212 does not make a good electrical connection with the solder paste 208, unlike the first ink 212. In some cases, the solder paste 208 at least partially overlaps one or more of the first ink 212 or the second ink 214. For example, the solder paste 208 can be one layer of multiple layers on the substrate 202.

[0094] In some cases, the first ink 212 and the second ink 214 have different impedance variability. For example, when stretched, the impedance on the ink may change. For example, in some cases, the conductive ink 212 or 214 may have a relatively low impedance variability such that when stretched, the impedance of the ink is relatively constant. As another example, in some cases, the conductive ink 212 or 214 may have a relatively high impedance variability such that when stretched, the impedance of the ink fluctuates. In some cases, the first ink 212 has a higher impedance variability than the second ink 214, while in other cases, the second ink 214 has a higher impedance variability than the first ink 214. As described herein, the substrate 202 is substantially flexible and prone to bending. Thus, in some cases, it may be advantageous to utilize an ink with a lower impedance variability in at least a portion of the areas on the substrate 202 that are prone to bending or stretching in order to minimize or limit impedance changes due to stretching.

[0095] 2B , the second ink 214 is utilized to make electrical connections other than for attaching electronic components 204. For example, the second ink 214 may form conductive traces that electrically connect various points or electronic devices on the substrate 202. As another example, the second ink 214 may electrically couple two different portions of the first ink 212 or create a connection to a component or device that is remote from the substrate 202.

[0096] It will be understood that the arrangement of the first ink 212 and the second ink 214 can be varied as desired or can be varied based on, for example, the properties and / or characteristics of the first and second inks 212, 214. For example, in some cases, the first ink 212 and the second ink 214 are at least partially mixed or at least partially overlapping. As another example, the first and second inks 212, 214 can be shorter, longer, thinner, or thicker than shown. Furthermore, in some cases, at least some portions of the first ink 212 and the second ink 214 are directly connected to each other. In some cases, at least some portions of the first ink 212 and the second ink 214 are indirectly connected to each other. For example, at least some portions of the first ink 212 and the second ink 214 can be connected to each other via conductive glue, conductive tape, or the like.

[0097] Additionally, in some cases, the electrical connections 210 may include fewer or more types of conductive inks. For example, a particular electrical connection 212 may include a first conductive ink, while a different electrical connection 212 may include a second conductive ink and a third conductive ink.

[0098] 2A and 2B, FIG 2C illustrates a cross-sectional view of a portion of an example wound monitoring and / or therapy device 260 including electronic components 204 electrically coupled to a substrate 202 via solder paste 208 and multiple electrical connections 210. FIG 2C further illustrates an example of electrical connections 210 including multiple types of conductive inks (e.g., first ink 212 and second ink 214) and a conductive medium 220 between the multiple types of conductive inks.

[0099] In some cases, the first ink 212 and the second ink 214 may at least partially overlap. For example, the first ink 212 and the second ink 214 may at least partially overlap at a junction or a point where the first ink 212 and the second ink 214 converge. In some cases, overlapping the inks 212 and 214 at the convergence point may improve the electrical connection between the first ink 212 and the second ink 214, for example, compared to connecting them side-by-side. Although the first ink 212 is illustrated as extending over the second ink 214 to partially cover at least a portion of the second ink 214, in some cases, at least a portion of the second ink 214 extends over at least a portion of the first ink 212. Additionally, it will be understood that the first ink 212 and the second ink 214 may have various configurations. For example, in some cases, at least some portions of the first ink 212 and the second ink 214 are side-by-side. As another example, in some cases, at least some portions of the first ink 212 and the second ink 214 are mixed together or layered on top of each other.

[0100] In some cases, the first ink 212 and the second ink 214 may be connected to one another using a conductive medium 220. For example, the conductive medium 220 may include solder paste, conductive glue, conductive tape, or the like. In some cases, the conductive medium 220 improves the connectivity between the first ink 212 and the second ink 214. However, it will be understood that in some cases, the first ink 212 and the second ink 214 are directly connected without the conductive medium 220 therebetween. In some cases, any of the wound monitoring and / or therapy devices 200, 250, 260, or 270 may include an isolation mask or layer. For example, an isolation mask may be printed between two or more electrical connections 210 to maintain separation of the electrical connections 210. In some cases, the isolation mask allows for stacking or lamination of electrical connections 210 or electronic components 204 such that the isolation mask electrically isolates the stacked electrical connections 210 or electronic components 204.

[0101] fiber Similar to FIGS. 2A-2C, FIG. 2D illustrates a cross-sectional view of a portion of an exemplary wound monitoring and / or therapy device 270 including electronic components 204 electrically coupled to a substrate 202 via a plurality of electrical connections 210. FIG. 2D further illustrates an example of an electrical connection 210 including a plurality of electrical textiles 222 embedded (e.g., in a conductive ink, conductive medium, etc.) in at least a portion of the electrical connection 210. In some cases, the electrical textiles 222 can reduce impedance variations due to stretching of the electrical connection 210. For example, in some cases, during stretching of the electrical connection 210, the electrical textiles 222 can move around within the electrical connection 210 but maintain connections with other electrical textiles 222 within the electrical connection 210. In this manner, the electrical textiles 222 can prevent or limit impedance changes due to stretching.

[0102] As shown, one or more of the electrical connections 210 may include an electrical textile 222. For example, if the electrical connections 210 include a conductive ink, the one or more electrical textiles 222 may be in the conductive ink. In some cases, the electrical textile 222 may be utilized with a conductive ink that is subject to impedance variation with stretching, such as some examples of the first ink 212. In some cases, utilizing the electrical textile 222 in this manner results in the electrical connections 210 being thin or including thin traces.

[0103] In some cases, the electrical fabric 222 may include fibers, such as a single type of fiber or a blend of two or more types of fibers. For example, the electrical fabric 222 may include, but is not limited to, cotton, wool, jute, silk, polyester, polypropylene, nylon, Kevlar, or synthetic fibers.

[0104] It will be understood that the electric fabric 222 can be embedded in different patterns and densities, and the electric fabric 222 can have one or more different lengths. For example, in some cases, the electric fabric 222 includes one or more continuous strands of fibers 222 that extend across the length of the electrical connection 210. As another example, in some cases, the electric fabric 222 includes a plurality of relatively short electric fabrics 222. For example, during the stretching of the electrical connection 210, one or more electric fabrics 222 can move within the electrical connection 210 toward or away from other electric fabrics 222. In some cases, at least some of the electric fabrics 222 remain in contact with each other. For example, the electric fabrics 222 can be tightly packed within the electrical connection 210. In some cases, at least some of the electric fabrics 222 do not contact any other electric fabrics 222. For example, the electric fabrics 222 can be spaced across the electrical connection 210.

[0105] As shown, in some cases, the electrical connection 210 is directly coupled to the electrical connector 206. However, it will be understood that the electrical connection 210 may be indirectly coupled to the electrical connector 206, for example, via solder paste or conductive glue.

[0106] quality control In some cases, the electrical connection 210 may include one or more components or markers that may enable quality control of one or more of the various connections. For example, in some cases, the electrical connection 210 includes a fluorescent component. In some cases, the fluorescent component may be used for quality control, such as checking the connection under UV light. As another example, in some cases, the electrical connection 210 may be visible or may include a wireless transparent material that can be seen under an X-ray or MRI. In some cases, these components or markers may be biodegradable. In some cases, these markers may be used for quality control and / or may enable a user to check if or where electronics are present in the wound and / or wound dressing.

[0107] Conductive ink 3A-3C illustrate a substrate 202 supporting a plurality of electronic components 204 and a plurality of electrical connections 210 electrically connecting one or more of the electronic components 204. As discussed herein, the electrical connections 210 may include a first type of conductive ink 212 of a second type of conductive ink 214. Additionally, as described herein, the first ink 212 and the second ink 214 may have one or more different characteristics or properties, such as different impedances, variance in impedance (e.g., due to drawing of the ink), thermal conductivity, electrical conductivity, or the like.

[0108] As described herein, in some cases, the substrate 202 is flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover a wound. Thus, in some cases, it may be advantageous to utilize an electrical connection 210 that can be stretched. Additionally, it may be advantageous to utilize an electrical connection 210 whose properties (e.g., resistance) are not substantially affected when the electrical connection 210 is stretched. In some cases, the second ink 214 may have less resistance variation with stretching than the first ink 212. In some such examples, the second ink 214 may be selected to form a portion of the electrical connection 210 that is present on an area of ​​the substrate 202 that is likely to bend. For example, as shown in FIGS. 3A-3C, the electrical connection 210 extending across the substrate 202 may include the second ink 214.

[0109] In some cases, areas of the substrate 202 that include electronic components 204 may be less rigid or flexible than other areas of the substrate 202. In some such cases, the electrical connection 210 proximate (e.g., underlying and / or surrounding) the electronic components 204 may include a first ink 212. For example, as shown in FIGS. 3A-3C, a portion of the electrical connection 210 proximate the electronic components 204 may include a first ink 212, while other portions of the electrical connection 210 may include a second ink 214. In this manner, the second ink 214 may be utilized to enable electrical connections across the substrate 202 while also minimizing impedance changes due to stretching, and the first ink 212 may be utilized for its enhanced electrical and thermal conductivity compared to the second ink 214.

[0110] Other Variations In some cases, one or more electronic components may be located on the side of the substrate opposite the wound-facing side. The systems and methods described herein are equally applicable to such substrates. Although the specific embodiments described herein relate to wound dressings, the systems and methods disclosed herein are not limited to wound dressings or medical applications. The systems and methods disclosed herein are generally applicable to electronic devices, such as electronic devices that can be worn by or applied to a user.

[0111] Any values ​​of thresholds, limits, periods, etc. provided herein are not intended to be absolute values ​​and therefore may be approximate values. In addition, any thresholds, limits, periods, etc. provided herein may be fixed or variable, either automatically or by a user. Furthermore, as used herein, terms expressing a relative degree, such as above, over, under, etc., in relation to a reference value are intended to encompass equality to the reference value. For example, exceeding a positive reference value can encompass being equal to or greater than the reference value. Additionally, as used herein, terms expressing a relative degree, such as above, over, under, etc., in relation to a reference value are intended to encompass the inverse of the disclosed relationship, such as below, under, over, etc., in relation to a reference value. Furthermore, although various process blocks may be described with respect to determining whether a value reaches or does not reach a particular threshold, the blocks may equally be understood with respect to, for example, whether a value is (i) below or over a threshold, or (ii) meeting or not meeting a threshold.

[0112] It is understood that a feature, material, characteristic, or group described in connection with a particular aspect, embodiment, or example may be applied to any other aspect, embodiment, or example described herein, unless it is inconsistent therewith. All features disclosed in this specification (including any accompanying claims, abstract, and drawings), or all steps of any method or process disclosed in the same, may be combined in any combination, except combinations in which at least some of such features or steps are mutually exclusive. The subject matter is not limited to the details of any of the embodiments described above. The subject matter extends to any novel, or any novel combination, of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process disclosed in the same.

[0113] Although certain embodiments have been described, these embodiments are presented merely as examples and are not intended to limit the scope of the protected subject matter. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and changes may be made in the form of the methods and systems described herein. Those skilled in the art will appreciate that in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the drawings. In some embodiments, certain of the steps described above may be omitted, and others may be added. For example, the actual steps or order of steps performed in the disclosed processes may differ from those shown in the drawings. In some embodiments, certain of the steps described above may be omitted, and others may be added. For example, the various components illustrated in the drawings may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, and the like, may include logic circuits. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0114] Although the present disclosure includes certain specific embodiments, examples, and applications, those skilled in the art will appreciate that the present disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses, as well as obvious variations and equivalents thereof, including embodiments that do not provide all of the features and advantages described herein. Thus, the scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments herein, but may be defined by the claims presented herein or hereafter.

[0115] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context in which it is used, is typically intended to convey that a particular embodiment includes certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instructions, whether those features, elements, or steps are included in or should be performed in any particular embodiment. Terms such as "comprises," "including," and "having" are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive sense (rather than an exclusive sense), such that, for example, when used connecting a list of elements, the term "or" means one, some, or all of the elements in the list. Additionally, the term "each," as used herein, in addition to having its ordinary meaning, can also refer to any subset of the series of elements to which the term "each" is applied.

[0116] Conjunctive phrases such as "at least one of X, Y, and Z," unless specifically stated otherwise, are to be construed otherwise in accordance with the context in which they are generally used to suggest that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive phrases are generally not intended to suggest that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0117] Phrases expressing degrees, such as the terms "approximately," "about," "generally," and "substantially" as used herein, refer to a value, amount, or characteristic that is close to a given value, amount, or characteristic that still performs a desired function or produces a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given amount.

[0118] The scope of the disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims presented in this section or elsewhere herein, or presented hereafter. The claim language should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during the prosecution of this application, which examples should be interpreted as non-exclusive. [Explanation of symbols]

[0119] 100B, 100C Sensor integrated substrate (sensor sheet) 202 Base material 204 Electronic Components 206 Electrical Connectors 208 Solder Paste 210 Electrical Connection 212 First Ink 214 Second Ink

Claims

1. A sensor sheet, a plurality of electronic components including a first electronic component having a first electrical connector configured to electrically connect the first electronic component; a substantially flexible substrate having a first wound-facing side supporting the plurality of electronic components and a second side opposite the first side; a track of a first conductive ink present on the substantially flexible substrate, the first conductive ink having a first impedance, the track of the first conductive ink electrically coupled to the first electrical connector of the first electronic component; and a track of a second conductive ink present on the substantially flexible substrate, the second conductive ink having a second impedance different from the first impedance, the track of the second conductive ink being electrically coupled to the track of the first conductive ink; A sensor sheet that is flexible, elastic, stretchable, or stretchable, or substantially flexible, elastic, stretchable, or stretchable, to conform to or cover a surface.

2. 10. The sensor sheet of claim 1, further comprising a solder paste electrically coupled between the first electrical connector and the first conductive ink, the solder paste electrically coupling the first electrical connector and the first conductive ink.

3. The sensor sheet of claim 1 or 2, wherein the tracks of second conductive ink are electrically coupled to the first electronic component via the tracks of first conductive ink.

4. 4. The sensor sheet of claim 1, wherein the track of the first conductive ink is a first track of the first conductive ink, and the sensor sheet further comprises a second track of the first conductive ink coupled to the track of the second conductive ink.

5. 5. The sensor sheet of claim 4, wherein the second track of the first conductive ink is electrically coupled to the first track of the first conductive ink via the track of the second conductive ink.

6. 6. The sensor sheet of claim 1, wherein the track of the first conductive ink is a first track of the first conductive ink, the plurality of electronic components further includes a second electronic component having a second electrical connector, and the sensor sheet further includes a second track of the first conductive ink coupled to the second electrical connector of the second electronic component.

7. The sensor sheet of claim 6 , wherein the tracks of the second conductive ink are further coupled to the second tracks of the first conductive ink.

8. 7. The sensor sheet of claim 6, wherein the first electronic component is electrically coupled to the second electronic component via the first track of the first conductive ink, the track of the second conductive ink, and the second track of the first conductive ink.

9. 7. The sensor sheet of claim 6, wherein the track of the second conductive ink is a first track of the second conductive ink, and the sensor sheet further comprises a second track of the second conductive ink coupled to the second track of the first conductive ink.

10. The sensor sheet of any one of claims 1 to 9, wherein the first electronic component comprises at least one of a sensor, an amplifier, a capacitor, a resistor, an inductor, a controller, a processor, a diode, or a connector.

11. The sensor sheet of any one of claims 1 to 10, wherein at least one of the first conductive ink or the second conductive ink comprises a silver ink.

12. The sensor sheet according to any one of claims 1 to 11, wherein a variance in impedance caused by the extension of the second conductive ink is smaller than a variance in impedance caused by the extension of the first conductive ink.

13. The sensor sheet of any one of claims 1 to 12, wherein the first conductive ink has a first width, and the second conductive ink has a second width that is larger than the first width.

14. The sensor sheet according to any one of claims 1 to 13, wherein the thermal conductivity of the first conductive ink is higher than the thermal conductivity of the second conductive ink.

15. The sensor sheet of any preceding claim, wherein at least one of the first conductive ink or the second conductive ink comprises an electrowoven fabric.

16. The sensor sheet of claim 15 , wherein the electrofabric is cotton.

17. The sensor sheet of any one of claims 1 to 16, wherein the first conductive ink contains fibers, and the fibers reduce impedance dispersion due to stretching of the first conductive ink.

18. The sensor sheet according to any one of claims 1 to 17, wherein the first impedance is greater than the second impedance.

19. The sensor sheet according to any one of claims 1 to 18, wherein the first conductive ink has a higher conductivity than the second conductive ink.

20. The sensor sheet of any preceding claim, wherein at least a portion of the tracks of the second conductive ink overlap at least a portion of the tracks of the first conductive ink.

21. 21. The sensor sheet of claim 1, wherein the tracks of the second conductive ink are electrically coupled to the tracks of the first conductive ink using at least one of a conductive glue or a conductive tape.

22. 22. The sensor sheet of claim 1, wherein the first conductive ink comprises a first amount of silver, and the second conductive ink comprises a second amount of silver different from the first amount.

23. The sensor sheet of any one of claims 1 to 22, wherein at least one of the first inks of the second ink comprises silver, graphite, carbon, graphene, graphene oxide, carbon nanotubes, or nanosilver.

24. A wound monitoring and / or therapy system and / or method of operating and / or using said system or sensor sheet or as shown and / or described.

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