Sensor-compatible negative pressure wound monitoring device 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 on October 7, 2019, the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

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

[0003] Description of related art Almost every field of medicine can benefit from improved information regarding the state of the tissues, organs, or systems being treated, particularly when such information is collected in real - time during treatment. Without using sensor data collection, many types of treatments are still routinely performed, and instead, such treatments rely on visual inspection by caregivers or other limited means rather than quantitative sensor data. For example, in the case of wound treatment via dressings and / or negative pressure wound therapy, data collection is generally limited to visual inspection by caregivers, and often the underlying wound tissue can be obscured by dressings or other visual obstructions. Even on intact, unblemished skin, there may be underlying damage that is invisible to the naked eye, such as vulnerable blood vessels or deeper tissue damage that can lead to ulcers. Similar to wound treatment, during orthopedic treatments that require immobilization of limbs by casts or other enclosures, only limited information about the underlying tissues is collected. In the case of internal tissue repair, 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 the function of the underlying muscles or the movement of limbs. Beyond direct treatment, general hospital supplies such as beds and blankets can be improved by adding the ability to monitor patient parameters.

Prior Art Documents

[0004] [Patent Document 1] Special Publication No. 2005-532841 [Overview of the project] [Problems that the invention aims to solve]

[0005] Such wound monitoring and / or treatment systems present inherent problems due to their contact with tissue. Furthermore, wounds should heal without hindrance. At the same time, care must be taken to ensure the reliability and safety of such systems for use on human or animal tissue.

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

[0007] In some cases, the sensor sheet (such as a wound dressing) of a wound monitoring and / or therapy device includes multiple electronic components. The multiple 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 supporting the multiple electronic components, and a second side opposite the first side. The wound monitoring and / or therapy device may include a track of first conductive ink having a first impedance. The first conductive ink may be present on the substantially flexible substrate. The track of first conductive ink may be electrically coupled to a first electrical connector of the first electronic component. The wound monitoring and / or therapy device may include a track of second conductive ink having a second impedance different from the first impedance. The second conductive ink may be present on the substantially flexible substrate. A track of second conductive ink can be electrically coupled to a track of first conductive ink.

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

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

[0010] Any sensor sheet described in any of the three paragraphs above may also include any combination of the following features described in this paragraph, in particular: The impedance dispersion due to the stretching of the second conductive ink may be less than the impedance dispersion due to the 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 that of the second conductive ink. At least one of the first or second conductive ink may include an electric fabric. The electric fabric may be cotton.

[0011] Any sensor sheet described in any of the four paragraphs above may also include any combination of the following features described in this paragraph, in particular: The first conductive ink may include fibers. The fibers may reduce the dispersion of impedance due to the stretching of the first conductive ink. The first impedance may be greater than the second impedance. The first conductive ink may have higher conductivity than the second conductive ink. At least a portion of the tracks of the second conductive ink may overlap with at least a portion of the tracks of the first conductive ink. The tracks of the second conductive ink may be electrically coupled to the tracks of the first conductive ink using conductive glue. The tracks of the second conductive ink may be electrically coupled to the tracks of the first conductive ink using conductive tape. The first conductive ink may contain a first amount of silver. The second conductive ink may contain a second amount of silver, different from the first amount.

[0012] Any feature of any of the methods described herein may be used in conjunction with any feature of any of the other methods described herein. [Brief explanation of the drawing]

[0013] Embodiments of this disclosure will be described below only as examples, with reference to the attached drawings. [Figure 1A] Examples of wound monitoring or therapy systems are provided. [Figure 1B] Examples of substrates that support electronic components are shown. [Figure 1C] Examples of substrates that support electronic components are shown. [Figure 2A] The diagram 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] Figure 2A shows a cross-sectional view and further illustrates examples of electrical connections including multiple types of conductive inks. [Figure 2C] Figure 2A shows a cross-sectional view, further illustrating an example of overlapping electrical connections. [Figure 2D] Figure 2A shows a cross-sectional view, further illustrating an example of an electrical connection including one or more fibers. [Figure 3A] This shows a substrate that supports multiple electronic components and multiple electrical connections that electrically connect one or more of the electronic components. [Figure 3B] This shows a substrate that supports multiple electronic components and multiple electrical connections that electrically connect one or more of the electronic components. [Figure 3C] This shows a substrate that supports multiple electronic components and multiple electrical connections that electrically connect one or more of the electronic components. [Modes for carrying out the invention]

[0014] Embodiments disclosed herein relate to apparatus and methods for performing at least one of monitoring or treating biological tissue using a sensor-enabled substrate. While the systems and methods disclosed herein are not limited to treating or monitoring a particular type of tissue or injury, the sensor-enabled technologies disclosed herein are broadly applicable to any type of therapy that can benefit from a sensor-enabled substrate. In some embodiments, sensors and data collection trusted by healthcare professionals are utilized to perform both diagnostic and patient management decisions.

[0015] Some of the systems and methods disclosed herein relate to the use of sensors that are mounted on or embedded within a substrate configured to be used in the treatment of both intact and damaged human or animal tissue. Such sensors can 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 can be attached to the skin at any location on the body, including areas that tend to have arthritis, temperature, or other areas that are prone to problems and require monitoring. The sensors disclosed herein can also incorporate markers, such as radiopaque markers, to indicate the presence of the device, for example, before performing an MRI or other technique.

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

[0017] The sensor systems and methods disclosed herein can be incorporated into a cushioning material or bed pad, such as within a hospital bed, to monitor patient characteristics, such as any of the characteristics disclosed herein. In certain cases, a disposable film containing such sensors can be placed on top of a hospital bed and removed / replaced as needed.

[0018] In some embodiments, the sensor systems and methods disclosed herein may incorporate energy harvesting so that the sensor systems and methods operate autonomously. For example, energy may be recovered 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, which may be useful for diagnosing concussions.

[0020] The sensor systems and methods disclosed herein may be used in cooperation 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 the 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 the surgical site. Additional surgical data may be collected to assist in preventing scarring and monitoring areas away from the affected area.

[0021] To further support surgical techniques, the sensors disclosed herein may be incorporated into surgical drapes to provide information about tissue beneath the drape that may not be immediately visible to the naked eye. For example, a sensor-embedded flexible drape may have sensors advantageously positioned to provide improved area-focus data acquisition. In certain embodiments, the sensor systems and methods disclosed herein may be incorporated within or at the boundary of the drape to create fencing that restricts / controls surgical theatrical movement.

[0022] The sensor systems and methods disclosed herein may also be used for preoperative evaluation. For example, such sensor systems and methods may be used to collect information about potential surgical sites, such as by monitoring the skin and underlying tissues for possible incision sites. For example, perfusion levels or other desirable characteristics may be monitored at the surface of the skin and deeper in the tissues to assess whether an individual patient may be at risk of surgical complications. Sensor systems and methods, such as those disclosed herein, may be used to assess the presence of microbial infections and to provide instructions for the use of antimicrobial agents. Furthermore, the sensor systems and methods disclosed herein may be able to collect additional information in deeper tissues, such as by identifying pressure ulcer injuries and / or adipose tissue levels.

[0023] The sensor embodiments disclosed herein may be used for cardiovascular monitoring. For example, such sensor systems and methods may be incorporated into a flexible cardiovascular monitor that can be positioned against the skin to monitor characteristics of the cardiovascular system and transmit such information to another device and / or caregiver. For example, such a device may monitor pulse rate, blood oxygenation, and / or electrical activity of the heart. Similarly, the sensor systems and methods disclosed herein may be used for neurophysiological applications, such as monitoring the 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, the internal source may also provide power to such implants.

[0025] The sensor systems and methods disclosed herein may also be used to monitor biochemical activity on or beneath the surface of the skin, such as the accumulation of lactose in muscles or the amount of sweat on the skin surface. 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 used to monitor recovery from ENT-related surgery, such as wound monitoring within sinus passages.

[0027] The sensor systems and methods disclosed herein may include sensor printing techniques involving encapsulation, such as encapsulation using a polymer film. Such films may be constructed using any polymer described herein, such as polyurethane. The encapsulation may provide waterproofing of the electronic device, 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 position and provides protection. Furthermore, the sensor-embedded organ protection layer may be used 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. Furthermore, the sensor-enabled organ protection layer may be used to monitor the organ during transplantation and post-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 treating intact skin, cardiovascular applications such as blood flow monitoring, orthopedic applications such as limb movement and bone repair monitoring, neurophysiological applications such as electrical impulse monitoring, and any other tissues, organs, systems, or conditions that may benefit from improved sensor-responsive monitoring.

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

[0031] As used herein, the term “wound” may include injury to living tissue caused by a cut, blow, or other impact, typically an impact that cuts or breaks the skin. Wounds can be chronic or acute. Acute wounds result from surgery or trauma. They progress through stages of healing within a predicted time frame. Chronic wounds typically begin as acute wounds. Acute wounds can become chronic wounds when they do not follow the healing stages, resulting in prolonged recovery. The transition from acute to chronic wounds may be attributed to the patient being in an immunocompromised state.

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

[0033] Other examples of wounds include, but are not limited to, abdominal wounds, or other large or incisional wounds, dehiscences, acute wounds, chronic wounds, subacute wounds and dehiscences resulting from surgery, trauma, sternotomy, fasciotomy, or any other condition, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers and venous ulcers.

[0034] Wounds can also include deep tissue injuries. Deep tissue injury is a term proposed by the National Pressure Ulcer Advisory Panel (NPUAP) to describe a specific form of pressure ulcer. These ulcers have been described by clinicians for many years using terms such as purple pressure ulcers, potentially worsening ulcers, and bony bruises.

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

[0036] Some disclosures relate to methods for treating wounds using the techniques disclosed herein, in combination with one or more of the following: advanced footwear, patient turning, off-roading (e.g., off-roading of diabetic foot ulcers), treatment of infection, systemics, antimicrobial agents, antibiotics, surgery, tissue removal, effects on blood flow, physiotherapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, activator ozone, antibiotics, antimicrobial agents, etc.

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

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

[0039] In some cases, wound dressings include one or more absorbent layers. These absorbent layers may be foams or superabsorbent materials.

[0040] In some cases, the disclosed technology may be used in conjunction with non-negative pressure wound dressings. A non-negative pressure wound dressing suitable for providing protection at the wound site may comprise 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 an absorbent layer overlaps the wound contact layer. The wound contact layer may carry an adhesive portion for forming a substantially fluid seal on the wound.

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

[0043] In some cases, the wound dressings disclosed herein further include a backing layer. The backing layer may be a transparent or opaque film. Typically, the backing layer includes 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, and is typically an open-cell foam. The foam may also be hydrophilic.

[0045] The wound dressing may include a permeable layer, which may be made of foam. The permeable layer may be a polyurethane foam laminated onto a polyurethane film.

[0046] Non-negative pressure wound dressings may be compression bandages. Compression bandages are known for their use in the treatment of edema, as well as other venous and lymphatic system disorders, such as those of the lower extremities. A compression bandage may comprise a bandage system including an endothelial-facing layer and an elastic outer layer, wherein the inner layer comprises a first ply of foam and a second ply of absorbent nonwoven fabric web, and the inner and outer layers are elongated enough to be wrapped around the limbs of the patient.

[0047] Negative pressure wound therapy In some cases, wound treatment may be carried out using negative pressure wound therapy. It will be understood that the systems and methods of this disclosure may be applicable in general to use with TNP systems. In short, negative pressure wound therapy can help close and heal many forms of “difficult-to-heal” wounds by reducing tissue edema, promoting blood flow and granular tissue formation, and removing excess exudate, thereby reducing bacterial load (and therefore risk of infection). In addition, the therapy can reduce wound anxiety, leading to earlier healing. TNP therapy systems may also assist in the healing of surgically closed wounds by helping to remove fluid and stabilize tissue in a parallel position of closure. Further beneficial uses of TNP therapy can be found in grafts and flaps where removing excess fluid is important and it is required that the graft be in close proximity to the tissue to ensure tissue viability.

[0048] Negative pressure therapy can be used to treat open or chronic wounds that are too large to close naturally, or otherwise will 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 dressing over the wound, using various means to seal the dressing against the patient's surrounding tissue, and connecting a negative pressure source (such as a vacuum pump) to the dressing in a manner that creates and maintains negative pressure directly beneath the dressing. Such negative pressure is thought to promote wound healing by removing excess fluid, which may contain harmful cytokines or bacteria, while simultaneously facilitating granulation tissue formation at the wound site and supporting the normal inflammatory process within the body.

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

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

[0051] In some wound closure devices described herein, increased wound reduction may lead to increased tissue expansion in the surrounding wound tissue. This effect may be amplified, in some cases, by changing the force applied to the tissue, for example, by changing the negative pressure applied to the wound over time, in conjunction with an increase in the tensile force applied to the wound by some wound closure devices. In some cases, the negative pressure may be changed over time, for example, using a sine wave, a square wave, or in synchronization with one or more physiological indicators (such as heart rate).

[0052] Any of the systems and methods disclosed herein are described in WO2010 / 061225, US2016 / 114074, US2006 / 0142560, and US5,703,225 describing absorbent materials, WO2013 / 007973 describing non-negative pressure wound dressings, GB1618298.2 (filed October 28, 2016), GB1621057.7 (filed December 12, 2016), and GB1709987.0 (filed June 22, 2017) describing multilayer wound dressings, and EP2498829 and EP171825 describing wound dressings. 7. It may be used in combination with any of the features disclosed in one or more of the following applications: WO2006 / 110527, US6,759,566, and US2002 / 0099318 describing compression bandages; US8,235,955, and US7,753,894 describing wound closure devices; and WO2013 / 175306, WO2016 / 174048, US2015 / 0190286, US2011 / 0282309, and US2016 / 0339158 describing negative pressure wound therapy dressings, wound dressing components, wound therapy devices, and methods. Each of the disclosures of these applications is incorporated herein by reference in whole.

[0053] Sensor-enabled wound monitoring and therapy system Figure 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 have various sensors embedded in it, or otherwise placed within the dressing 22, to collect measurement data from one or more areas surrounding the wound, such as the wound or the area surrounding the wound (which may include undamaged skin). The control module 24 can receive, store, and process the 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 re-sterilized 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, reusable, re-sterilized, or otherwise disinfected or sterilized. The control module 24 may be positioned on the wound dressing 22. The control module 24 may be spatially separated from the wound dressing 22, for example, by a cable or another wired or wireless electrical connection. The control module 24 may include a power supply (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 collect information about the patient or environmental conditions located away from the wound dressing 22. In some cases, one or more sensors in 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 condition, etc.

[0056] The control module 24 can communicate data to the communication device 30 when requested, periodically, or similarly. When the communication device is placed within communication range, communication can be conducted via a wired or wireless interface, such as via near-field communication (NFC), RFID, or similar. For example, the communication range may be close to the control module 24, such as within approximately 3 cm or less or more. The communication device 30 may be placed within 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 data. Communication may be carried out via the transfer of hardware or data storage devices, such as one or more memory storage devices (e.g., SD cards). In some cases, communication may be carried out non-electronically, such as visually, audibly, or tactilely, and one or more of the control module 24 or the communication device 30 may 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 a personal computer, tablet, or smartphone, via a wired or wireless interface. For example, the wired USB protocol may be used for data communication between device 30 and device 40. In another example, data communication may be carried out via the transfer of hardware or data storage devices, such as one or more memory storage devices (e.g., SD cards). In some cases, data communication may be carried out non-electronically, such as visually, audibly, or tactilely, and one or more of the communication device 30 or computing devices 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 the data collected from the dressing 22 and the perfusion determination device 70, which is configured to determine the skin perfusion pressure and communicate the data to the computing device 40 via a wired or wireless interface. For example, a wired USB protocol may be used for communication between device 70 and 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 medical data. In some cases, the remote computing device 50 may be a cloud computing device that includes one or more of the following means of remote storage, servers, processing devices, or information storage. For example, the 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 & Accountability Act (HIPAA) or the European Union Directive on Data Protection. The remote computing device 50 may make available the data provided by one or more of the computing device 40 or the mobile device 60 for remote access and viewing, 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, additional data may be added by the mobile device 60 via a dedicated app, a web browser interface, or similar. The remote computing device 50 can process data from one or more of the wound dressing 22, the perfusion determination device 70, or a 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 capture one or more images of a patient's wound. This data can be transmitted to a remote computing device 50 via a wired or wireless interface. Although a smartphone is illustrated, the mobile device 60 may 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 healthcare professional in response to a questionnaire.

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

[0062] In some embodiments, several sensor technologies may be used in one or more components that form part of a wound dressing or an overall wound dressing device. For example, as illustrated in Figures 1B and 1C, one or more sensors may be incorporated on or within a substrate (such a substrate may be referred to as a “sensor-integrated substrate” or “sensor-compatible substrate”). While the substrate is illustrated as having a rectangular shape, it will be understood that the substrate may have other shapes such as rectangular, circular, or elliptical. In some cases, the substrate supporting one or more sensors may be provided as individual material layers that are placed directly or indirectly on or within 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 within the wound and subsequently covered by a secondary wound dressing, which may include one or more of the following: gauze, foam, or other wound packaging materials, superabsorbent layers, drapes, or fully integrated dressings such as Pico or Allevyn Life dressings manufactured by Smith & Nephew.

[0063] The sensor-integrated substrate may be positioned in contact with the wound, allowing a fluid to pass through the substrate without causing little or no damage to the tissue within the wound. The substrate may be flexible, elastic, stretchable, or elastic, or substantially flexible, elastic, stretchable, or elastic, in order to conform to or cover the wound. For example, the substrate may be made from stretchable or substantially stretchable materials such as polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, polyimide, polyamide, polyester, polyethylene tetraphthalate (PET), polybutene tetraphthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymer (FEP) and copolymer materials, or other suitable materials.

[0064] Elastic or substantially elastic materials can be stretched to 5% or more, 10% or more, 20% or more, or more than 20% of their initial dimensions, such as length or width. In some cases, elastic or substantially elastic materials can return to within 5% or more of their initial dimensions (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 from flexible polymers including polyamide, polyimide (PI), polyester, polyethylene naphthalate (PEN), polyetherimide (PEI), and various fluoropolymers (FEP) and copolymers. One or more sensors may be incorporated into a two-layer flexible circuit. In some scenarios, one or more circuit substrates may be multilayer flexible circuit substrates.

[0066] In some cases, the sensor integration 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 can be positioned, may be incorporated into any layer of the wound dressing. For example, a wound contact layer may have notches or slits that protrude from the lower surface of the wound contact layer and allow one or more sensors to make direct contact with the wound. In some situations, one or more sensors may be incorporated into or encapsulated within other components of the wound dressing, such as an absorbent layer.

[0067] As shown in Figure 1B, the sensor-integrated substrate 100B may support a plurality of electronic components and a plurality 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, and diodes. 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 containing 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] Multiple electronic components may include one or more impedance or conductivity sensors 110, which can be arranged in an outer 4x4 grid and an inner 4x4 grid, as illustrated in Figures 1B and 1C. Sensors 110 are exemplified as pads configured to measure the impedance or conductivity of tissue across any pair of pads. Two (or more) excitation pads 115, arranged as illustrated, provide excitation signals across the pads, which are conducted by the tissue, and in response, the impedance or conductance of the tissue can be measured across the pads 110. One or more electronic components, such as amplifiers 120, may be used to measure the impedance or conductance of the tissue. The impedance or conductance measurements may be used to identify living and dead tissue, monitor the progress of healing, etc. The arrangement of pads 110 in the inner and outer grids may be used to measure the impedance or conductance of a wound, the periphery of a wound, or the tissue or area surrounding a wound.

[0069] Multiple 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 arranged around the outer periphery of the substrate 100B. One or more temperature sensors may include one or more thermocouples or thermostats. One or more temperature sensors may be calibrated, and the data obtained from one or more sensors may be processed to provide information about the wound environment. In some cases, an ambient sensor measuring the ambient air temperature may be used to help rule out problems associated with ambient temperature shifts.

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

[0071] In some cases, ultra-high-brightness 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, since surface color may be measured from reflected light, color may be measured from the light that first passes through the tissue for a given geometric shape. This may include color sensing from diffused light from an LED in contact with the skin. In some cases, the LED may be used with a proximal RGB sensor to detect light diffused through the tissue. The optical sensor may image using diffused internal light or surface reflected light.

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

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

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

[0075] In some cases, a substrate may be coated to enclose or cover one or more of the substrate or components supported by the substrate. The coating may provide biocompatibility, shield or protect electronic circuits from contact with liquids, or provide pads for electronic components to increase patient comfort. 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] Soft coats can be formed from one or more suitable polymers, adhesives such as 1072-M adhesives (e.g., Dymax 1072-M), 1165-M adhesives (e.g., Dymax 1165-M), parylene (e.g., Parylene C), silicone, epoxy, urethane, acrylic urethane, acrylic urethane substitutes (e.g., Henkel Loctite 3381), or other suitable biocompatible and substantially stretchable materials. Soft coats can be thin coatings ranging from, for example, about 80 microns or less to several millimeters or more. Soft coats may have hardnesses lower than about A100, A80, A50 or less. Soft coats may have elongation at fracture exceeding about 100%, 200%, or 300% or more. Soft coats may have viscosities of about 8,000 to 14,500 centipoise (cP). In some cases, the coatings may have viscosities of about 3,000 cP or more. In some cases, the coating may have a viscosity of less than approximately 3,000 cP.

[0077] In some cases, it may be desirable for the substrate to be stretchable or substantially stretchable in order to better conform to or cover the wound, but at least some of the electronic components or connections do not need to be stretchable or flexible. In such cases, undesirable or excessive local strain or stress may be exerted on one or more electronic components, such as the support area or attachment point of the electronic components, when the substrate is positioned in or over the wound. 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, detach, or malfunction (e.g., generate an open circuit from a disconnected pin or another connector). Alternatively or additionally, it may be desirable to maintain the position of one or more electronic components, such as one or more sensors, in the same or substantially the same location or area relative to the wound (e.g., in contact with the wound) so that the 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. The surface of a stretchable substrate may move, for example, when the patient moves, but it may be desirable to maintain the same or substantially the same position of one or more electronic components relative to the wound.

[0078] To address these issues, in some cases, a non-stretchable or substantially non-stretchable coating (such coatings may also be referred to as "hard coats") may be applied to one or more electronic components, one or more electrical connections, etc. The hard coat may provide one or more of the following: reinforcement or stress relief for one or more electronic components, one or more electrical connections, etc. The hard coat may be formed from acrylic or modified urethane materials. 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 other suitable materials. 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. Hard courts can have a hardness of approximately D40 to D65 and / or a linear shrinkage of approximately 1.5 to 2.5%.

[0079] Any hard coat or soft coat described herein may be cured by one or more of the following methods: lamination, bonding, welding (e.g., ultrasonic welding), light, UV, heat (e.g., heating). Any hard or soft coat described herein may be transparent or substantially transparent to facilitate the transmission of light through the coating, such as for photosensitive applications. Any coating described herein may retain its adhesive strength when subjected to sterilization, such as EtO sterilization. Any coating described herein may be modified to emit fluorescence, such as under UV light.

[0080] In some implementations, the boundaries or edges of the substrate may be smoothed by cutting, have a smooth contour, or contain fibers 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. 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 a control module 24. One or more antennas may be used additionally to receive power wirelessly from a power source. In certain cases, one or more antenna traces may be positioned on a substantially non-stretchable material (as described herein) such that the resonant frequencies of one or more antennas remain fixed when the substrate is under stress during use with a patient. Fixing 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, filed April 24, 2019, entitled "Sensor Integrated Dressings And Systems," which describes various dressing materials and their components, and GB Application No. 1905696.9, filed January 20, 2019, entitled "Sensor Integrated Dressings And Systems," which describes various dressing materials and their components. The disclosures of each of these applications are incorporated herein by reference in their entirety.

[0083] Electrical connections on the substrate Figure 2A shows a partial cross-sectional view of an exemplary wound monitoring and / or therapy device 200, which includes electronic components 204 electrically coupled to a substrate 202 via solder paste 208 and a plurality of electrical connections 210. It will be understood that the wound monitoring and / or therapy device 200 may include fewer or more components, if 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. Furthermore, in some cases, the electronic components 204 may be directly coupled to the electrical connections 210 rather than indirectly coupled to the electrical connections 210 via, for example, solder paste 208.

[0084] The electronic component 204 may be identical or similar to any electronic component described herein, such as a sensor, amplifier, capacitor, resistor, inductor, controller, processor, diode, or connector. As shown in the illustration, the electronic component 204 may include a plurality of 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 connector 206 includes one or more of electrical pads, pins, or tabs. The electrical connectors 206 may be used 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 identical 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 properties of the sensor integration substrate 100B in Figure 1B or the sensor integration substrate 100C in Figure 1C. For example, in some cases, the substrate 202 is flexible, elastic, stretchable, or elastic, or substantially flexible, elastic, stretchable, or elastic, for conforming to or covering a wound. In some cases, it may be advantageous to utilize an electrically stretchable electrical connection 210. In some cases, the area of ​​the substrate 202 containing the electronic component 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 the substrate 202 or integrated with the substrate 202. For example, the electrical connections 210 may be screen printed on 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 on 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 inks (e.g., inks containing one or more of silver, graphite, carbon, graphene, graphene oxide, carbon nanotubes, nanosilver), nanotechnology-based conductive inks, organic conductive inks, conductive glues, conductive tapes, fibers, solder paste, or the like. As described herein, in some cases, the electrical connections 210 may include one or more types of conductive inks, conductive glues, conductive tapes, fibers, solder paste, or the like. For example, a first type of conductive ink may be used in a first location on the substrate 202, and a second type of conductive ink may be used in a second location on the substrate 202. In some such embodiments, the use or arrangement of different types of conductive inks may be based at least in part on one or more features or properties of the conductive inks. For example, a more conductive ink may be used in a region or area for soldering, and a different ink (e.g., an ink whose resistance does not change dramatically when stretched) may be used in one or more other areas on the substrate 202. In this way, the wound monitoring and / or therapy device 200 can take advantage of the benefits of multiple conductive inks. In another embodiment, a more conductive ink, or an ink with a lower impedance, may be used for communication signals such as antenna traces.

[0088] In some cases, one or more portions of the solder paste 208 can be printed onto the electrical connection 210 or the substrate 202. For example, the solder paste 208 can be printed onto the electrical connection 210 and / or the substrate 202, and then heated (together with the rest of the board) to melt the solder paste 208 and form a mechanical and electrical connection. In some cases, the solder paste 208 is replaced with a different material such as conductive glue or conductive tape. In some cases, the wound monitoring and / or therapy device 200 does not contain solder paste 208. For example, in some cases, the electronic component 204 may be directly coupled to the electrical connection 210 rather than indirectly coupled to the electrical connection 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, impedance dispersion (e.g., due to ink stretching), thermal conductivity, electrical conductivity, etc., may vary depending on the type of ink used. Consequently, some inks may be better suited to some purposes, and others to others. Therefore, in some cases, the wound monitoring and / or therapy device 200 may utilize electrical connections 210 containing multiple types of conductive inks. Furthermore, in some cases, a particular type of conductive ink may be placed on the substrate 202 based on its advantageous properties. Thus, in some implementations, for example, two or more different types of conductive inks may be placed (or combined) on the substrate 202 to take advantage of the beneficial properties of different types of conductive inks. However, it will be understood that in some cases, one or more types of conductive inks may be placed on the substrate 202 without considering, or contrary to, one or more of their properties (e.g., thermal conductivity, electrical conductivity, impedance, flexibility, etc.).

[0090] Similar to Figure 2A, Figure 2B shows a cross-sectional view of a portion of an exemplary wound monitoring and / or therapy device 250, including a solder paste 208 and electronic components 204 electrically coupled to a substrate 202 via a plurality of electrical connections 210. Figure 2B further shows an embodiment 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 the first ink 212) and a second type of conductive ink 214 (sometimes referred to herein as the second ink 214). Although Figure 2B discusses 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. Furthermore, although 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 relatively high conductivity may allow for thinner traces and / or improved electrical connections. Thus, in some cases, an ink 212 or 214 with higher conductivity may be used in the contact area of ​​the electronic component 204 (e.g., the area where the electronic component 204 is connected to the substrate) and / or in areas for various connections, such as the ink footprint around the electronic component 204. Furthermore, in some cases, an ink 212 or 214 with higher conductivity may be used to mount the electronic component 204 to the substrate 202. Furthermore, in some cases, an ink 212 or 214 with higher conductivity may be used for communication signals, such as antenna traces. As shown in the embodiment of Figure 2B, the first ink 212 is used to mount the electronic component 204. Therefore, in some cases, the first ink 212 has higher conductivity than the second ink 214. However, in some cases, the second ink 214 has higher conductivity than the first ink 212, or the first ink 212 and the second ink 214 have approximately equal conductivity. In some cases, one ink has higher conductivity than the other inks because it contains more or a particular metal (e.g., silver), and is thicker or wider.

[0092] In some cases, the first ink 212 and the second ink 214 have different thermal conductivity. 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 from the solder paste 208. For example, in some cases, the first ink 212 makes good electrical connections with the solder paste 208, while the second ink 212, unlike the first ink 212, does not make good electrical connections with the solder paste 208. In some cases, the solder paste 208 overlaps at least partially with one or more of the first ink 212 or the second ink 214. For example, the solder paste 208 can be one of several 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 relatively low impedance variability so that the impedance of the ink remains relatively constant when stretched. In another embodiment, in some cases, the conductive ink 212 or 214 may have relatively high impedance variability so that the impedance of the ink fluctuates when stretched. In some cases, the first ink 212 has higher impedance variability than the second ink 214, while in other cases, the second ink 214 has higher impedance variability than the first ink 214. As described herein, the substrate 202 is substantially flexible and easily bent. Therefore, in some cases, it may be advantageous to use an ink with lower impedance variability in at least a portion of the area on the easily bent or stretched substrate 202 in order to minimize or limit the impedance change due to stretching.

[0095] As shown, in the embodiment of Figure 2B, the second ink 214 is used to make electrical connections other than those for mounting 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. In another embodiment, the second ink 214 may electrically couple two different parts of the first ink 212 or create connections to components or devices that are detached from the substrate 202.

[0096] It will be understood that the arrangement of the first ink 212 and the second ink 214 can be changed as desired, or can be changed based on the properties and / or characteristics of the first and second inks 212 and 214, for example. For example, in some cases, the first ink 212 and the second ink 214 are at least partially mixed or at least partially overlapping. In another embodiment, the first and second inks 212 and 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 may be connected to each other via conductive glue, conductive tape, or the like.

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

[0098] Similar to Figures 2A and 2B, Figure 2C shows a partial cross-sectional view of an exemplary wound monitoring and / or therapy device 260, which includes a solder paste 208 and electronic components 204 electrically coupled to a substrate 202 via a plurality of electrical connections 210. Figure 2C further shows an example of the electrical connections 210, which include a plurality of types of conductive inks (e.g., a first ink 212 and a second ink 214) and a conductive medium 220 between the plurality of types of conductive inks.

[0099] In some cases, the first ink 212 and the second ink 214 may overlap at least partially. For example, the first ink 212 and the second ink 214 may overlap at least partially 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 a convergence point can improve the electrical connection between the first ink 212 and the second ink 214 compared to, for example, connecting them side by side. Although the first ink 212 is shown extending over the second ink 214 so as 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 so as to cover at least a portion of the first ink 212. Furthermore, it will be understood that the first ink 212 and the second ink 214 may have a variety of configurations. For example, in some cases, at least a portion of the first ink 212 and the second ink 214 are arranged side by side. In another embodiment, in some cases, at least a portion 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 each other using a conductive medium 220. For example, the conductive medium 220 may include solder paste, conductive glue, conductive tape, or similar. In some cases, the conductive medium 220 improves connectivity between the first ink 212 and the second ink 214. However, in some cases, it will be understood that the first ink 212 and the second ink 214 are directly connected without a conductive medium 220 in between. In some cases, one 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 the isolation 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 Figures 2A-2C, Figure 2D shows a partial cross-sectional view of an exemplary wound monitoring and / or therapy device 270, which includes an electronic component 204 electrically coupled to a substrate 202 via a plurality of electrical connections 210. Figure 2D further shows an embodiment of the electrical connection 210 that includes a plurality of electrowoven fabrics 222 embedded (e.g., in conductive ink, a conductive medium, etc.) in at least a portion of the electrical connection 210. In some cases, the electrowoven fabrics 222 can reduce impedance fluctuations due to stretching of the electrical connection 210. For example, in some cases, during stretching of the electrical connection 210, the electrowoven fabrics 222 can move around within the electrical connection 210 but maintain connections with other electrowoven fabrics 222 within the electrical connection 210. In this way, the electrowoven fabrics 222 can prevent or limit impedance changes due to stretching.

[0102] As shown in the figure, one or more of the electrical connections 210 may include an electrowoven fabric 222. For example, if the electrical connection 210 contains a conductive ink, one or more electrowoven fabrics 222 may be in the conductive ink. In some cases, the electrowoven fabric 222 may be used with a conductive ink that is susceptible to impedance fluctuations due to stretching, such as some embodiments of the first ink 212. In some cases, using the electrowoven fabric 222 in this way results in the electrical connection 210 becoming thinner or containing a thin trace.

[0103] In some cases, the electrowoven 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 electrowoven 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 electrowoven fabric 222 can be embedded in different patterns and densities, and that the electrowoven fabric 222 can have one or more different lengths. For example, in some cases, the electrowoven fabric 222 includes one or more continuous strands of fibers 222 that extend over the length of the electrical connection 210. In another embodiment, in some cases, the electrowoven fabric 222 includes a plurality of relatively short electrowoven fabrics 222. For example, during the stretching of the electrical connection 210, one or more electrowoven fabrics 222 can move within the electrical connection 210, moving toward or away from other electrowoven fabrics 222. In some cases, at least a portion of the electrowoven fabrics 222 remain in contact with each other. For example, the electrowoven fabrics 222 can be tightly condensed within the electrical connection 210. In some cases, at least a portion of the electrowoven fabrics 222 do not come into contact with any other electrowoven fabrics 222. For example, the electrowoven fabrics 222 may be spaced apart over the entire electrical connection 210.

[0105] As illustrated, 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 enable quality control of one or more different connections. For example, in some cases, the electrical connection 210 may include a fluorescent component. In some cases, the fluorescent component may be used for quality control, such as checking the connection under UV light. In another embodiment, in some cases, the electrical connection 210 may include a wirelessly transparent material that is visible or can be seen under 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 enable a user to check whether electronics are present in a wound and / or wound dressing, or where electronics are present.

[0107] Conductive ink Figures 3A to 3C show a substrate 202 supporting a plurality of electronic components 204 and a plurality of electrical connections 210 that electrically connect one or more of the electronic components 204. As discussed herein, the electrical connections 210 may include a first type of conductive ink 212 and a second type of conductive ink 214. Furthermore, as described herein, the first ink 212 and the second ink 214 may have one or more different features or properties, such as different impedances, impedance dispersion (e.g., due to ink stretching), thermal conductivity, electrical conductivity, or the like.

[0108] As described herein, in some cases the substrate 202 is flexible, elastic, stretchable, or elastic, or substantially flexible, elastic, stretchable, or elastic, for conforming to or covering a wound. Therefore, in some cases it may be advantageous to use an electrical connection 210 that can be stretched. Furthermore, it may be advantageous to use an electrical connection 210 whose properties (e.g., resistance) are substantially unaffected when stretched. In some cases the second ink 214 may exhibit less resistance variation due to stretching than the first ink 212. In some such embodiments, 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 be bent. For example, as shown in Figures 3A-3C, an electrical connection 210 extending across the substrate 202 may include the second ink 214.

[0109] In some cases, the area of ​​the substrate 202 containing the electronic component 204 may be less rigid or flexible than other areas of the substrate 202. In some such cases, electrical connections 210 adjacent to (e.g., beneath and / or around) the electronic component 204 may include the first ink 212. For example, as shown in Figures 3A-3C, the portion of the electrical connection 210 adjacent to the electronic component 204 may include the first ink 212, while other portions of the electrical connection 210 may include the second ink 214. Thus, the second ink 214 may be used to enable electrical connections across the substrate 202 while also minimizing impedance changes due to stretching, and the first ink 212 may be used 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 positioned on the side of the substrate opposite to the side facing the wound. The systems and methods described herein are equally applicable to such substrates. While 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 in general, such as electronic devices that may be worn by or applied to a user.

[0111] Any values ​​such as thresholds, limits, and periods provided herein are not intended to be absolute values ​​and may therefore be approximate. In addition, any thresholds, limits, periods, etc. provided herein may be fixed or variable, either automatically or by the user. Furthermore, as used herein, terms expressing relative degrees such as above, greater than, and less than a reference value are intended to also include cases where the value is equal to the reference value. For example, exceeding a positive reference value may include being greater than or equal to the reference value. Furthermore, as used herein, terms expressing relative degrees such as above, greater than, and less than a reference value are intended to also include the opposite of disclosed relationships such as below, less than, and greater than a reference value. Furthermore, blocks of various processes may be described in relation to determining whether a certain value reaches or does not reach a particular threshold, but blocks may also be understood, for example, in relation to whether a certain value is (i) less than or greater than a threshold, or (ii) meets or does not meet a threshold.

[0112] Features, materials, properties, or groups described in relation to a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described herein, insofar as they do not conflict with such other aspects, embodiments, or examples. All features disclosed herein (including any accompanying claims, abstract, and drawings), or any steps of any method or process disclosed herein, may be combined in any combination except for any combination in which at least some of such features or steps are mutually exclusive. The protected subject matter is not limited to the details of any embodiment described herein. The protected subject matter extends to any novel features or any novel combination of features disclosed herein (including any accompanying claims, abstract, and drawings), or any novel steps or any novel combination of any steps of any method or process disclosed herein.

[0113] While certain embodiments are described, these embodiments are presented merely as examples and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications can be made in the forms of the methods and systems described herein. Those skilled in the art will understand 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 steps from the steps described above may be omitted, or others may be added. For example, the actual steps or the order of steps performed in the disclosed processes may differ from those shown in the drawings. In some embodiments, certain steps from the steps described above may be omitted, or others may be added. For example, various components illustrated in the drawings may be implemented as processors, controllers, ASICs, FPGAs, or as software or firmware on 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 remain within the scope of this disclosure.

[0114] This disclosure includes certain embodiments, examples, and uses, but those skilled in the art will understand that this disclosure extends beyond the scope of the specifically disclosed embodiments to other alternative embodiments or uses, as well as obvious variations and equivalents thereof, which may not provide all of the features and advantages described herein. Therefore, the scope of this disclosure is not intended to be limited by the specific disclosure of preferred embodiments herein, but may be defined by the claims presented herein or thereafter.

[0115] Conditional phrases such as “can,” “could,” “might,” or “may” are typically intended to convey that a particular embodiment includes a particular feature, element, or step, while other embodiments do not, unless otherwise specifically stated or interpreted within the context in which they are used. Therefore, such conditional phrases are generally not intended to suggest that a feature, element, or step is required to some extent in one or more embodiments, or that logic for determining, with or without user input or instruction, whether these features, elements, or steps are included in any particular embodiment, or should be implemented in any particular embodiment, is necessarily included in one or more embodiments. Terms such as “equip,” “include,” and “have” are synonymous and are used inclusively and in an open-ended manner, not excluding additional elements, features, actions, or behaviors. Furthermore, the term "or" can be used in an inclusive sense (rather than an exclusive sense), for example, when used to connect a list of elements, meaning one, some, or all of the elements in the list. In addition, the term "each," when used herein, can mean any subset of the set of elements to which the term "each" applies, in addition to its usual meaning.

[0116] Conjunctional phrases such as "at least one of X, Y, and Z" are to be interpreted differently depending on the context in which they are commonly used to suggest that an item or term may be one of X, Y, or Z, unless otherwise specifically stated. Therefore, such conjunctional 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] The terms used herein to express degree, such as “approximately,” “about,” “generally,” and “substantially,” refer to values, quantities, or characteristics that approximate a given value, quantity, or characteristic that still perform the desired function or produce the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of a given quantity.

[0118] The scope of this disclosure is not intended to be limited by any specific disclosure of preferred embodiments in this section or elsewhere in this specification, but may be defined by the claims presented in this section or elsewhere in this specification, or presented hereafter. The language of these claims should be interpreted broadly based on the language used in these claims, and not limited to the examples described herein or in the proceedings of this application, and such examples should be interpreted non-exclusively. [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 The First Ink 214 The Second Ink

Claims

1. It is a sensor sheet, A plurality of electronic components, including the first electronic component, each having a first electrical connector configured to electrically connect the first electronic component, A substantially flexible substrate having a first wound-facing side and a second side opposite the first side, supporting the plurality of electronic components, A track of a first conductive ink present on the substantially flexible substrate, wherein the first conductive ink has a first impedance, and the track of the first conductive ink is electrically coupled to the first electrical connector of the first electronic component, A track of a second conductive ink present on the substantially flexible substrate, wherein the second conductive ink has a second impedance different from the first impedance, and the track of the second conductive ink is electrically coupled to the track of the first conductive ink, The track of the first conductive ink is the first track of the first conductive ink, the plurality of electronic components further include 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. The track of the second conductive ink is further coupled to the second track of the first conductive ink. To conform to or cover a surface, it is flexible, elastic, stretchable, or elastic, or substantially flexible, elastic, stretchable, or elastic. Sensor sheet.

2. The sensor sheet according to claim 1, further comprising a solder paste electrically coupled between the first electrical connector and the first conductive ink, wherein the solder paste electrically couples the first electrical connector and the first conductive ink.

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

4. The sensor sheet according to any one of claims 1 to 3, wherein the track of the first conductive ink is a first track of the first conductive ink, and the sensor sheet further includes a second track of the first conductive ink coupled to the track of the second conductive ink.

5. The sensor sheet according to 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. The sensor sheet according to claim 1, 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.

7. The sensor sheet according to claim 1, wherein the track of the second conductive ink is the first track of the second conductive ink, and the sensor sheet further includes the second track of the second conductive ink coupled to the second track of the first conductive ink.

8. The sensor sheet according to any one of claims 1 to 7, wherein the first electronic component includes at least one of a sensor, amplifier, capacitor, resistor, inductor, controller, processor, diode, or connector.

9. The sensor sheet according to any one of claims 1 to 8, wherein at least one of the first conductive ink or the second conductive ink comprises silver ink.

10. The sensor sheet according to any one of claims 1 to 9, wherein the impedance dispersion due to the stretching of the second conductive ink is smaller than the impedance dispersion due to the stretching of the first conductive ink.

11. The sensor sheet according to any one of claims 1 to 10, wherein the first conductive ink has a first width, and the second conductive ink has a second width greater than the first width.

12. The sensor sheet according to any one of claims 1 to 11, wherein the thermal conductivity of the first conductive ink is higher than the thermal conductivity of the second conductive ink.

13. The sensor sheet according to any one of claims 1 to 12, wherein at least one of the first conductive ink or the second conductive ink includes an electrowoven fabric.

14. The sensor sheet according to claim 13, wherein the electrowoven fabric is cotton.

15. The sensor sheet according to any one of claims 1 to 14, wherein the first conductive ink includes fibers, and the fibers reduce the dispersion of impedance due to the stretching of the first conductive ink.

16. The sensor sheet according to any one of claims 1 to 15, wherein the first impedance is greater than the second impedance.

17. The sensor sheet according to any one of claims 1 to 16, wherein the first conductive ink has higher conductivity than the second conductive ink.

18. The sensor sheet according to any one of claims 1 to 17, wherein a portion of the track of the second conductive ink overlaps with a portion of the track of the first conductive ink.

19. The sensor sheet according to any one of claims 1 to 18, wherein the track of the second conductive ink is electrically coupled to the track of the first conductive ink using at least one of conductive glue or conductive tape.

20. The sensor sheet according to any one of claims 1 to 19, wherein the first conductive ink contains a first amount of silver, and the second conductive ink contains a second amount of silver different from the first amount.

21. The sensor sheet according to any one of claims 1 to 20, wherein at least one of the second conductive ink and the first conductive ink comprises silver, graphite, carbon, graphene, graphene oxide, carbon nanotubes, or nanosilver.

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