SMART WOUND DRESSING WITH INTEGRATED MICRO-SENSORS FOR REAL-TIME WOUND HEALING MONITORING

Abstract

Smart Wound Dressing with Integrated Micro-Sensors for Real-Time Wound Healing Monitoring This invention describes a Smart Wound Dressing with Integrated Sensors is a novel medical device designed to enable continuous, non-invasive, real-time monitoring of wound healing. Embedded with micro-sensors measuring temperature, pH, and moisture, the dressing autonomously tracks critical wound parameters indicative of healing status. Data collected is processed by an integrated control module, which compares readings to pre-set thresholds. When abnormalities, such as infection risks, are detected, the dressing’s wireless transmitter sends alerts to a secure healthcare platform, enabling timely intervention. Constructed from breathable, hypoallergenic materials, the dressing offers a flexible, comfortable fit suited for prolonged wear. Its single-use design, complete with an embedded power source, ensures hygienic, reliable functionality for the entire duration of application. By allowing remote wound monitoring and providing real-time alerts, this smart dressing apparatus significantly enhances wound management, reduces patient visits, and supports data-informed healthcare decisions to improve patient outcomes.

Specification

Description:[0001] This invention relates to the field of pharmaceutical sciences more particularly to an advanced medical wound care device, specifically to non-invasive, intelligent wound dressings equipped with integrated micro-sensors for continuous, real-time monitoring of key healing parameters, including temperature, pH, and moisture content. The invention facilitates remote healthcare monitoring through a wireless data transmission apparatus that enables early detection of wound complications and provides customizable, data-driven insights to healthcare providers. This innovation addresses critical needs in wound management by offering a comprehensive, autonomous solution that enhances wound assessment accuracy, improves patient outcomes, and reduces the frequency of in-person clinical visits.

PRIOR ART AND PROBLEM TO BE SOLVED

[0002] Chronic wounds, such as pressure ulcers, diabetic ulcers, and venous leg ulcers, present a significant healthcare challenge due to their prolonged healing time and susceptibility to infection. These wounds often require continuous monitoring to assess healing progress and detect early signs of complications, such as infection or excessive inflammation. Traditional wound care involves physical inspections by healthcare professionals, which can be infrequent, costly, and invasive. This process risks cross-contamination and introduces discomfort to patients during dressing changes, potentially disrupting the healing environment. Wound dressings must strike a balance between protecting the wound and enabling monitoring, as removing the dressing too frequently can disturb the healing tissue and delay recovery.
[0003] Additionally, chronic wounds are typically characterized by complex and dynamic healing environments, where factors like moisture, pH, temperature, and oxygen levels can fluctuate. Proper management of these variables is essential for optimal healing. However, conventional wound dressings lack the ability to provide real-time feedback on these conditions. Consequently, healthcare providers rely on subjective visual assessment or laboratory tests, which may not be timely enough to intervene at critical points, often leading to worsened conditions, infection, or even tissue necrosis.
[0004] Existing methods for wound care, while numerous and varied, face critical limitations that impede their effectiveness in managing chronic wounds. Hydrocolloid and hydrogel dressings, for instance, are widely used for their ability to maintain a moist healing environment, which supports autolytic debridement and helps protect the wound. However, they lack the ability to provide real-time data on essential wound conditions such as moisture balance or pH levels. This deficiency requires routine changes and physical inspections to assess wound health, which not only disrupts the healing process but also increases the risk of infection, leading to higher healthcare costs and patient discomfort.

[0005] Antimicrobial dressings that incorporate agents like silver offer some protection against infection, yet they fall short in providing any dynamic insights into wound healing progress. The inability of these dressings to actively monitor wound conditions means that infections or other complications may go undetected until symptoms visibly worsen. Additionally, prolonged use of antimicrobial agents poses a risk of developing resistant strains of bacteria, and some patients may experience skin irritation or allergic reactions to these agents, further complicating wound management.
[0006] Efforts to leverage telemedicine and wearable technology for wound monitoring have shown some promise in allowing remote data collection. However, these approaches frequently lack the accuracy needed for in-wound monitoring, as sensors positioned externally may struggle to capture subtle changes within the wound environment itself. Furthermore, these apparatuss can be prone to signal interference from the dressing materials or external factors, which compromises data reliability and can lead to inaccurate assessments that could ultimately affect patient outcomes.
[0007] Attempts to employ electrochemical and optical sensors to measure specific wound characteristics, like oxygen or glucose levels, have also encountered challenges. These technologies are often suited for controlled laboratory settings rather than routine clinical use, where they may be too costly or impractical for everyday application. Most of these sensors are separate from the dressing, requiring removal for each test and thus introducing the risk of contaminating the wound site and causing unnecessary disruption to the healing process. Thus, while advancements in wound care technology have been made, substantial barriers remain in creating a reliable, accessible, and non-disruptive monitoring apparatus for chronic wound management.
[0008] Several technological solutions have been introduced in an attempt to address the challenges of monitoring and managing chronic wounds, yet each approach reveals specific limitations that restrict their efficacy in clinical settings. Hydrocolloid and hydrogel dressings, for example, are commonly used in wound care for their ability to maintain a stable, moist environment that can promote healing. Although effective in certain scenarios, these dressings lack any embedded sensing capabilities to monitor real-time conditions within the wound, such as pH, temperature, or moisture. Consequently, healthcare providers must rely on frequent dressing changes and physical inspections, which can disrupt the wound environment, increase infection risk, and drive up both the cost and time demands of wound care.
[0009] Another category of wound dressings, incorporating antimicrobial agents such as silver, is intended to proactively prevent infection. These dressings can reduce bacterial load but do not monitor or provide feedback on the healing progress. As a result, they cannot inform caregivers of changing conditions within the wound, limiting their role to passive infection prevention rather than active wound management. Prolonged use of antimicrobial agents also poses risks; it can lead to resistant bacterial strains and cause adverse skin reactions in some patients. Therefore, while antimicrobial dressings offer some preventive benefits, their inability to track healing metrics leaves them inadequate for addressing the complexities of chronic wound care.

[0010] In recent years, telemedicine and wearable technology have emerged as promising methods to enable remote wound monitoring. These apparatuss utilize external sensors or smartphone applications to collect data near the wound site, offering convenience for remote monitoring. However, external sensors often fail to provide accurate readings within the wound itself. Because they monitor conditions from a distance, these devices may not capture critical in-wound factors like moisture balance or precise temperature variations, leading to potentially misleading or inconclusive data. Furthermore, wearable devices are subject to signal interference from both the dressing materials and external factors, which compromises the accuracy and reliability of the readings. This technological gap limits the effectiveness of telemedicine and wearable solutions for direct, in-wound monitoring.
[0011] Electrochemical and optical sensors have been developed to measure specific parameters, such as oxygen concentration or glucose levels, in a laboratory context. While highly effective in controlled environments, these sensors are not easily adapted for routine, clinical wound care due to high costs, complexity, and limited practical applications in real-world healthcare settings. Many of these sensors are not integrated directly into wound dressings, requiring removal and reapplication with each test. This process disrupts the wound, introduces potential contamination risks, and is impractical for long-term wound care management outside of specialized clinical laboratories.
[0012] Finally, even with real-time data, interpreting sensor output is a complex challenge. Each wound type and patient's healing process varies widely, which complicates the task of translating sensor data into actionable clinical insights. Effective data interpretation often requires advanced algorithms or specialized expertise, adding another layer of complexity to the application of these technologies. As a result, while prior technologies for wound monitoring and care have made incremental improvements, their limitations underscore the need for a more effective, user-friendly, and accessible solution for chronic wound management.
[0013] To resolve the above mentioned problem the Smart Wound Dressing with Integrated Sensors is an advanced, non-invasive dressing designed to continuously monitor wound healing by measuring essential parameters such as temperature, pH, and moisture. These parameters are collected by embedded micro-sensors and transmitted wirelessly to a secure healthcare platform, where healthcare providers can track real-time data. Abnormal trends generate instant alerts, allowing timely intervention to prevent complications. Designed for comfort, the breathable dressing conforms closely to the skin, making it suitable for extended wear. The device reduces the need for frequent hospital visits by allowing remote monitoring, facilitating consistent wound assessment, and improving patient care through early detection of potential issues. It is crafted for single-use, ensuring hygiene and safety with its biocompatible and hypoallergenic materials, enhancing comfort and healing.

THE OBJECTIVES OF THE INVENTION:

[0014] Existing solutions for wound management, while offering various levels of support in wound care, fall short in multiple critical areas, limiting their ability to provide comprehensive and responsive monitoring. For instance, hydrocolloid and hydrogel dressings are beneficial in maintaining a moist environment that encourages healing, yet they lack embedded monitoring capabilities. This omission means that caregivers cannot track essential parameters like moisture, pH, or temperature, necessitating regular dressing changes and physical inspections to assess the wound's condition. Such frequent disruptions not only increase the risk of infection but also delay healing by repeatedly exposing the wound, causing discomfort for patients and significantly raising the cost of care.
[0015] It has already been proposed that antimicrobial dressings containing agents like silver offer infection protection but fail to actively monitor wound conditions. These dressings can reduce bacterial loads but do not provide insights into wound healing progress or environmental changes. Without feedback on in-wound parameters, caregivers remain unaware of worsening conditions until visible symptoms emerge. Additionally, extended use of antimicrobial dressings risks bacterial resistance and can lead to adverse skin reactions, such as irritation or allergic responses, further complicating wound management.
Advanced electrochemical and optical sensors have also been designed to measure certain wound parameters, such as oxygen or glucose levels, but they often require controlled laboratory conditions. These technologies are expensive and complex, making them impractical for widespread clinical use. Many of these sensors are not integrated into the dressings and must be applied and removed separately, which interrupts the wound's healing environment and raises the risk of contamination. This separation from the wound limits the practicality of these sensors for ongoing, day-to-day monitoring.
[0016] The principal objective of the invention is a Smart Wound Dressing Apparatus that incorporates integrated micro-sensors for continuous, non-invasive, real-time monitoring of wound healing parameters, specifically including temperature, pH, and moisture content. This apparatus features a wireless data transmission module for secure and remote relay of wound condition data to a healthcare provider platform, enabling the prompt detection and reporting of abnormal trends indicative of potential complications, such as infection. The primary objective is to enhance the accuracy, objectivity, and timeliness of wound assessment, supporting early interventions and improving patient outcomes through non-invasive, comprehensive monitoring of wound health.
[0017] Another objective of the invention is to incorporate micro-sensors embedded within the dressing material, configured to continuously measure temperature, pH levels, and moisture content in real-time. The objective is to automate data collection on key wound healing indicators, thereby eliminating the need for subjective, manual inspection by healthcare providers and facilitating a more reliable assessment of wound conditions.
[0018] The further objective of the invention is to integrate a compact, low-energy wireless transmitter within the dressing's design, ensuring secure data transmission of the collected parameters to a remote healthcare platform. This enables healthcare providers to monitor the wound condition remotely, thus reducing the necessity for frequent in-person assessments and supporting seamless integration into existing healthcare monitoring apparatuss.
[0019] The further objective of the invention is an automated alert mechanism that analyzes real-time data for pre-set thresholds of temperature, pH, and moisture, indicative of wound health. This feature shall be capable of sending immediate notifications to healthcare providers upon detecting values outside of normative healing ranges, allowing for early intervention in cases of complications such as infection or delayed wound healing.
[0020] The further objective of the invention is to construct the dressing from biocompatible, hypoallergenic materials that ensure user comfort through prolonged wear. The dressing design shall be breathable, allowing natural airflow to the wound site, while maintaining flexibility to conform to skin contours without restricting patient movement, thereby facilitating comfortable, long-term use.
[0021] The further objective of the invention is the dressing to be disposable, single-use item, ensuring hygienic application to mitigate risks of cross-contamination. The design shall incorporate a compact, integrated power source that powers the sensors and transmitter for the dressing's duration of use, obviating the need for recharging and facilitating safe disposal.
[0022] The further objective of the invention is to provide a cloud-based, secure monitoring platform accessible to healthcare providers, featuring an intuitive dashboard that displays real-time data, historical trends, and trend analysis. The apparatus shall allow customization of alert thresholds based on each patient's unique wound condition, enabling personalized and precise monitoring aligned with individual healing profiles.
[0023] The further objective of the invention is to ensure the dressing is easy to apply and remove via a specially designed adhesive backing, providing secure and stable attachment to the skin. The integrated sensors and transmitter shall be embedded within the dressing in a manner that does not interfere with its flexibility, breathability, or adhesive properties, maintaining consistent sensor contact with the wound site for accurate data capture.

SUMMARY OF THE INVENTION

[0024] The complexities of chronic wound care demand a solution that goes beyond traditional dressings, yet current approaches fall short in critical areas. Chronic wounds, including diabetic ulcers, pressure sores, and venous ulcers, pose a significant healthcare challenge, primarily due to their prolonged healing times, susceptibility to infection, and the need for ongoing monitoring. These wounds are characterized by intricate, fluctuating environments where factors such as moisture, pH, temperature, and oxygen levels can directly impact healing outcomes. Maintaining an optimal healing environment is essential, as fluctuations in any one of these factors can lead to delayed healing, increased infection risk, or even tissue necrosis. However, conventional dressings are limited in their ability to maintain and monitor these crucial conditions, creating a substantial gap in effective wound care.

[0025] A primary issue in managing chronic wounds is the need for continuous monitoring. Without real-time data on wound conditions, caregivers must rely on periodic inspections to assess healing progress and detect complications. This approach is problematic; routine physical inspections often necessitate dressing removal, which exposes the wound to pathogens, disrupts the delicate healing environment, and can cause significant discomfort for patients. For wounds that require extended healing times, the cumulative effect of frequent dressing changes can slow recovery and elevate the risk of cross-contamination, making wound management more challenging and costly. This problem is further compounded by the fact that infections or inflammatory responses may go undetected between inspections, resulting in delayed intervention and, potentially, more severe complications.
[0026] Efforts to integrate sensors within wound dressings have sought to address these limitations, yet several obstacles persist. For instance, even with sensor integration, achieving accurate readings in the moist, chemically dynamic environment of a chronic wound is challenging. Embedded sensors must be biocompatible and able to withstand prolonged exposure to wound exudate without affecting the surrounding tissue or altering the wound's chemical balance. Many current solutions struggle to maintain sensitivity and reliability under these conditions, leading to inaccurate readings or premature sensor failure. Furthermore, signal interference within the dressing material or from external factors, such as nearby medical equipment, can compromise data quality, making it difficult to detect subtle changes in wound parameters. These technical issues reduce the reliability of sensor data and hinder their practical application in daily wound care.
[0027] Power requirements present another complication. Many sensor-integrated dressings rely on batteries to function, but batteries add bulk and often require frequent replacement, which diminishes patient comfort and increases operational complexity. In addition to size and comfort constraints, battery-powered sensors may interfere with certain dressing materials, creating further challenges for maintaining consistent performance. Attempts to use low-power or alternative energy sources are still under development and are often limited by technical feasibility and cost, which restricts widespread adoption of sensor-integrated dressings, particularly in low-resource settings where advanced wound care options are already limited. While existing efforts to create sensor-integrated wound dressings represent progress, they remain constrained by technical, economic, and practical limitations. These challenges underscore the pressing need for a more effective wound care solution-one that can reliably monitor real-time wound conditions, offer accurate, actionable data, and maintain patient comfort and accessibility without compromising on the complexities of chronic wound care.
[0028] So here in this invention the Smart Wound Dressing with Integrated Sensors provides real-time wound monitoring, offering significant improvements in wound care through continuous assessment of healing parameters such as temperature, pH, and moisture. Micro-sensors embedded within the dressing capture data, which is wirelessly transmitted to a healthcare provider's platform, offering real-time wound insights. This dressing apparatus aims to address limitations in traditional wound assessment, including subjective evaluation and infrequent monitoring, which can lead to complications like infections. The dressing's design ensures comfort for the wearer, conforming to the skin with a breathable, hypoallergenic material that maintains an optimal healing environment. It is designed for single use, reducing cross-contamination risks. Real-time alerts prompt timely interventions if abnormal healing trends are detected, reducing the need for in-person assessments. As a disposable, convenient, and effective monitoring solution, the Smart Wound Dressing enables accurate wound care and enhances patient outcomes.

DETAILED DESCRIPTION OF THE INVENTION

[0029] While the present invention is described herein by example, using various embodiments and illustrative drawings, those skilled in the art will recognise recognize invention is neither intended to be limited that to the embodiment of drawing or drawings described nor designed to represent the scale of the various components. Further, some features that may form a part of the invention may not be illustrated with specific figures for ease of illustration. Such omissions do not limit the embodiment outlined in any way. The drawings and detailed description are not intended to restrict the invention to the form disclosed. Still, on the contrary, the invention covers all modification/s, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims. The headings are used for organizational purposes only and are not meant to limit the description's size or the claims. As used throughout this specification, the worn "may" be used in a permissive sense (That is, meaning having the potential) rather than the mandatory sense (That is, meaning, must).
[0030] Further, the words "an" or "a" mean "at least one" and the word "plurality" means one or more unless otherwise mentioned. Furthermore, the terminology and phraseology used herein is solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents and any additional subject matter not recited, and is not supposed to exclude any other additives, components, integers or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents acts, materials, devices, articles and the like are included in the specification solely to provide a context for the present invention.
[0031] In this disclosure, whenever an element or a group of elements is preceded with the transitional phrase "comprising", it is also understood that it contemplates the same component or group of elements with transitional phrases "consisting essentially of, "consisting", "selected from the group comprising", "including", or "is" preceding the recitation of the element or group of elements and vice versa.
[0032] Before explaining at least one embodiment of the invention in detail, it is to be understood that the present invention is not limited in its application to the details outlined in the following description or exemplified by the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for description and should not be regarded as limiting. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Besides, the descriptions, materials, methods, and examples are illustrative only and not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention.
[0033] The present invention is a Smart Wound Dressing with Integrated Temperature, pH, and Moisture Sensors, a wound care solution meticulously engineered to provide continuous, non-invasive, and real-time monitoring of wound healing parameters. This advanced dressing apparatus is purposefully designed to address critical limitations in traditional wound assessment, which relies on subjective and infrequent evaluations by healthcare providers. By offering objective and immediate feedback on the wound environment, this dressing apparatus enables healthcare providers to proactively assess wound healing progress, allowing for early detection of potential complications, such as infection or delayed healing. The apparatus aims to enhance patient care by supporting prompt, data-driven clinical decisions, ultimately improving patient outcomes in acute and chronic wound management scenarios. The breathable material ensures a conducive environment for wound healing by allowing for natural airflow, thereby reducing risks of maceration and irritation commonly associated with traditional dressings. The dressing's flexible structure accommodates a range of wound sites, supporting ease of movement and ensuring minimal disruption to daily activities. Its single-use promotes hygiene and safety, particularly beneficial for patients requiring prolonged wound care, as it reduces the likelihood of cross-contamination and simplifies application and removal.
[0034] This apparatus continuously monitors critical wound healing indicators, including temperature, pH levels, and moisture content, which are essential markers of wound health. By capturing these metrics, the dressing offers an ongoing, non-invasive assessment of the wound environment, thereby mitigating the limitations associated with periodic, in-person inspections. Through its real-time data transmission capability, the dressing allows healthcare providers to access wound condition data remotely, thus facilitating seamless integration into telemedicine frameworks and reducing the need for frequent clinical visits. Integrating automatic alerts for abnormal trends ensures that any detected deviation from normative healing parameters is promptly flagged, enabling healthcare providers to implement timely interventions and avoid escalating wound complications.
[0035] The Smart Wound Dressing apparatus's customizable alert settings allow healthcare providers to establish individualized thresholds based on the patient's unique wound condition. This feature ensures that monitoring is tailored precisely to the patient's healing trajectory, improving the precision of care and relevance of notifications. The apparatus's secure data transmission also safeguards patient privacy, supporting compliance with healthcare data regulations while enabling remote monitoring capabilities. This dressing apparatus thus presents a comprehensive wound management solution that combines advanced data monitoring with user-centred design, facilitating a seamless transition to next-generation wound care.
[0036] The Smart Wound Dressing with Integrated Sensors is a cutting-edge device that redefines wound care through its continuous, objective, and real-time monitoring capabilities. By enabling early detection of complications, enhancing patient comfort, and supporting data-driven clinical decisions, the dressing embodies a transformative approach to wound management. The apparatus's design not only alleviates the burden on healthcare providers but also empowers patients with a more consistent and convenient wound care solution, setting a new standard in the monitoring and treatment of wounds.Here, the Smart Wound Dressing with Integrated Temperature, pH, and Moisture Sensors is constructed from a flexible, biocompatible material designed to conform seamlessly to the body's contours, providing a secure and unobtrusive fit around the wound site. Its soft, hypoallergenic surface allows optimal skin contact, promoting comfort during prolonged wear and reducing potential irritation. The material is carefully chosen for breathability, enabling adequate airflow to the wound while simultaneously creating a protective barrier against external contaminants, thus establishing an environment conducive to natural healing.
[0037] At first glance, the dressing's surface is smooth, free of visible seams or raised sections, effectively masking the presence of embedded micro-sensors that monitor key healing parameters. The sensors are delicately integrated within the dressing's layers, ensuring they are invisible to the naked eye. This seamless integration preserves the dressing's aesthetic simplicity and maintains its flexibility, allowing it to adapt naturally to the body's movements without compromising its adhesion or functionality.Positioned discreetly at the edge of the dressing is a low-profile transmitter module, a compact and unobtrusive component responsible for wireless data transmission. This transmitter is designed with an exceedingly slim profile, positioned to remain outside the primary dressing area so as not to interfere with the wound site. It is small enough to be concealed beneath clothing without causing discomfort or drawing attention, preserving the user's privacy and allowing for normal activities without hindrance. The transmitter's edge placement ensures easy access for healthcare providers if needed while minimizing any interaction with the wound area, safeguarding the sterile field and maintaining the dressing's integrity.
[0038] The adhesive backing of the dressing is formulated for secure yet gentle adhesion to the skin, providing stability over the wound area throughout extended wear. This backing material is designed to be non-irritating, allowing for painless application and removal while preventing slippage or detachment during daily activities. The adhesion is sufficient to ensure reliable sensor contact with the skin, ensuring consistent and accurate data collection, even in environments where moisture or movement may present a challenge.
[0039] The Smart Wound Dressing with Integrated Temperature, pH, and Moisture Sensors comprises an intricately designed apparatus of components, each embedded within the dressing to perform specialized functions critical to its primary objective of continuous, real-time wound monitoring. At the core of this apparatus are micro-sensors calibrated to detect temperature, pH levels, and moisture content, parameters essential for assessing wound health. Each sensor type is strategically positioned within the dressing's layered structure to ensure optimal contact with the wound environment, enabling it to capture accurate and dynamic readings. These sensors are designed to operate synergistically, gathering data that collectively provide a comprehensive profile of the wound's healing status. The sensors are highly sensitive and equipped to detect minute changes in the wound environment, such as temperature fluctuations indicative of infection or abnormal pH levels signalling delayed healing, and they do so without interfering with the dressing's comfort or breathability. For example, temperature sensors continuously monitor for increases that may indicate the onset of infection. pH sensors detect deviations from the normal pH range, signaling potential complications such as delayed healing or bacterial growth. Meanwhile, moisture sensors keep track of the wound's hydration levels, essential for assessing the wound's optimal healing environment and preventing issues like desiccation or excessive moisture, which can slow recovery. The integration of these micro-sensors within the dressing's breathable material ensures that they maintain contact with the wound while remaining unobtrusive, effectively capturing data without disrupting patient comfort.
[0040] These sensors operate in a synchronized manner, collecting continuous data on the wound's condition and transmitting it for further analysis. Positioned within the dressing's multi-layered structure, these sensors maintain optimal contact with the wound surface, ensuring accuracy and responsiveness. Their seamless integration within the dressing's breathable material preserves the dressing's flexibility and comfort, allowing for uninterrupted monitoring during everyday activities.
[0041] The temperature sensor within the dressing is engineered to detect fluctuations in the wound's thermal state, which can be indicative of infection or inflammation. Calibrated for high sensitivity, this micro-sensor can detect minute changes in temperature that might otherwise go unnoticed during routine wound care. Utilizing thermistor or thermocouple technology, this sensor provides an accurate, stable reading of the wound's temperature in real time. The temperature sensor's compact design enables it to remain unobtrusive within the dressing, capturing reliable data while maintaining the dressing's sleek profile. By continuously monitoring for temperature increases, the sensor can alert healthcare providers to potential infections early on, allowing them to implement timely interventions and minimize the risk of complications.
[0042] The pH sensor is another integral component within the dressing, tasked with monitoring the acidity or alkalinity of the wound environment-a critical factor in evaluating the healing process. Variations in pH levels are strong indicators of wound health, with deviations from the normative range suggesting issues such as bacterial contamination or delayed healing. This sensor uses miniaturized ion-sensitive field-effect transistors (ISFET) or pH-sensitive hydrogel technology to detect pH changes. Positioned to maintain close contact with the wound surface, the pH sensor provides an immediate assessment of the wound's biochemical state, capturing data that can indicate infection risk or other abnormalities. Its precision is crucial in chronic wound management, as pH levels often correlate with underlying complications that could affect long-term healing. The pH sensor's miniature form factor and skin-safe design ensure that it integrates comfortably within the dressing, allowing for extended wear without discomfort.
[0043] The moisture sensor plays a vital role in evaluating the wound's hydration levels, a parameter essential for creating a conducive healing environment. This sensor utilizes either capacitive or resistive sensing technology to measure the wound's moisture content, determining whether the wound is too dry or overly moist. Both extremes can hinder the healing process; desiccation can cause tissue death, while excess moisture can lead to maceration. The moisture sensor is embedded within the dressing in such a way that it maintains direct exposure to the wound exudate, ensuring precise measurements. This continuous hydration assessment helps healthcare providers adjust treatment protocols to keep the wound environment balanced, ultimately optimizing conditions for natural healing. The sensor's ability to measure moisture consistently without adding bulk to the dressing makes it ideal for real-time wound management, giving patients freedom of movement without sacrificing functionality. Each sensor is embedded in specific layers of the dressing, carefully positioned to maintain close contact with the wound surface without disrupting the dressing's flexibility or breathability. This strategic placement optimizes data accuracy and sensor performance, allowing each micro-sensor to operate at peak sensitivity while remaining unobtrusive.
[0044] The dressing's temperature, pH, and moisture sensors are arranged within a multi-layered, biocompatible substrate designed to conform naturally to the wound site. The temperature sensor, typically located closest to the wound surface, uses conductive pathways to continuously monitor heat levels across the wound area. Above the temperature sensor, the pH sensor is integrated using ion-sensitive materials that detect pH changes within the wound exudate. The moisture sensor, positioned slightly above the other two sensors, employs capacitive or resistive circuitry to monitor the hydration level of the wound. This layered arrangement ensures that each sensor remains optimally placed for direct, real-time interaction with the wound environment, while the dressing's layered structure protects the delicate circuitry within.
[0045] The sensors are linked by ultrathin flexible circuitry, which connects each micro-sensor to the dressing's central control module. This circuitry is printed onto flexible, medical-grade conductive polymers, allowing the dressing to move with the patient without compromising the integrity of the connections. The control module, located near the dressing's edge, acts as the central hub where data from each sensor is processed and analyzed. Designed with an advanced microprocessor, the control module assesses the sensor data against predefined thresholds and determines if any parameter indicates an abnormal trend in wound healing.
[0046] The entire system is powered by a disposable, integrated micro-battery. This compact power source is embedded within the dressing, providing sufficient energy to support the sensors, control module, and wireless transmitter for the dressing's single-use period. The battery is specifically designed to maintain a low profile, so it does not add bulk to the dressing or interfere with its flexibility. Positioned strategically away from the wound site, it is encapsulated within a biocompatible layer to prevent any contact with the wound, ensuring both patient safety and reliable energy output.
[0047] A low-profile wireless transmitter located at the dressing's edge completes the system, responsible for relaying the processed data to an external healthcare platform. The transmitter is designed to use minimal power, thanks to a low-energy communication protocol, allowing it to work efficiently with the dressing's micro-battery. This transmitter wirelessly transmits wound data to a secure, cloud-based platform, enabling healthcare providers to remotely monitor the wound's condition and receive real-time alerts if any parameter deviates from expected healing ranges.
[0048] The integration of these components within the dressing's breathable material ensures a continuous, uninterrupted data flow. Each sensor operates autonomously, collecting and relaying data to the control module without manual intervention from the patient. Each sensor's data feeds into the dressing's central control module, which processes the readings against predefined thresholds and identifies abnormal trends. The synergy between these sensors enhances the dressing's diagnostic capabilities, enabling it to recognize complex healing dynamics and promptly signal any deviations. Their high sensitivity allows for the detection of subtle shifts in the wound environment, empowering healthcare providers to make proactive, data-driven decisions. By embedding these micro-sensors within the dressing's breathable and flexible structure, the Smart Wound Dressing ensures both the continuous gathering of crucial healing data and the maintenance of a comfortable, skin-friendly interface. This innovative design transforms wound care, providing a next-generation solution that aligns clinical precision with patient-centered usability.
[0049] Embedded within the dressing is a low-energy wireless transmitter, which serves as the conduit for data gathered by the sensors, seamlessly relaying this information to an external healthcare platform. The transmitter is configured to operate with minimal power, preserving the dressing's single-use design by eliminating the need for recharging or additional power sources. Positioned at the dressing's edge, this transmitter is intentionally isolated from the wound contact area to maintain sterility and prevent any interference with the healing process. The transmitter communicates wirelessly with a secure platform, transmitting data at set intervals or upon detecting abnormal trends. It operates on a specialized protocol that ensures data integrity and minimizes transmission interference, crucial for the reliability of the wound monitoring apparatus. This component is integral in enabling remote patient monitoring, allowing healthcare providers to review real-time wound data and respond promptly to complications without necessitating frequent in-person visits.
[0050] This transmitter serves as the central communication hub, seamlessly relaying sensor data from the dressing to a secure, cloud-based platform accessible by healthcare providers. Intentionally designed to be ultra-thin, this transmitter is positioned along the dressing's edge to avoid direct contact with the wound site. By placing the transmitter at the periphery, the dressing maintains sterility and ensures that the wound area remains free of any external interference. Its discreet positioning and slim profile prevent discomfort and allow patients to move freely, which is essential for daily wear and continuous monitoring.
[0051] The transmitter operates using a low-energy communication protocol, typically Bluetooth Low Energy (BLE) or Zigbee, chosen specifically for its minimal power consumption and efficient data transmission capabilities. This protocol allows the device to function continuously throughout the dressing's intended wear period without requiring recharging or external power sources. The transmitter's energy efficiency is critical to the dressing's single-use, disposable design, as it extends battery life and ensures the system can transmit data reliably until the dressing is safely discarded. By utilizing such a low-energy protocol, the transmitter preserves the small, integrated micro-battery within the dressing, allowing it to maintain continuous operation without needing additional energy inputs.
[0052] Functionally, the transmitter module is programmed to transmit data either at regular intervals or upon detecting abnormal readings from the sensors, which are processed by the dressing's control module. The transmitter's configuration allows it to send real-time updates on key parameters, such as temperature, pH, and moisture levels, to a secure platform. This real-time monitoring capability is fundamental for timely interventions; by alerting healthcare providers to any potential complications, such as temperature spikes or pH deviations indicative of infection, it allows for rapid clinical decision-making. Furthermore, the transmitter's specialized protocol minimizes transmission interference and maintains data integrity, critical in environments where multiple wireless devices might operate simultaneously.
[0053] The transmitter's hardware is composed of a miniaturized circuit board and antenna, both designed for flexibility and durability. The components are encapsulated in a medical-grade polymer coating to prevent any adverse reaction or contamination, allowing the device to remain safe and functional in proximity to the wound site. This encapsulation not only protects the transmitter from moisture and potential contamination but also ensures that it remains in a stable, sterile environment, essential for effective wound care. The antenna is optimized to maintain a stable connection within typical wireless transmission ranges, providing reliable connectivity even if the patient moves between rooms or varies their physical activity.
[0054] In terms of data transmission, the transmitter communicates securely with an external healthcare platform, typically via an encrypted connection to protect patient privacy and ensure compliance with healthcare data regulations. This secure connection is crucial in clinical settings, as it enables healthcare providers to monitor wound data remotely without risking unauthorized access. The platform itself features an intuitive interface where real-time data, historical trends, and alert notifications can be easily accessed by healthcare providers. This data access allows providers to track the healing process over time, detect potential complications early, and make adjustments to the treatment plan without requiring frequent in-person evaluations.
[0055] Each sensor's data is processed through an integrated control module within the dressing, a microprocessor programmed to analyse the individual parameters against predefined thresholds. This processing capability allows the dressing to recognize abnormal trends in wound healing autonomously, triggering immediate alerts when necessary. For instance, should the temperature sensor detect a rise beyond the normative threshold, signalling potential infection, the control module initiates an alert protocol, prompting the transmitter to send a real-time notification to the healthcare provider's monitoring apparatus. Similarly, pH imbalances or unusual moisture levels trigger corresponding alerts. This control module is embedded within the dressing's structure in a manner that preserves its thin, flexible profile, ensuring that the dressing remains comfortable and unobtrusive while providing sophisticated monitoring capabilities.
[0056] This module consists of a miniaturized microprocessor, specifically designed to operate within the confines of the dressing's ultra-thin structure. Carefully embedded into the layered fabric of the dressing, the control module's size and profile are engineered to preserve the flexibility and comfort of the dressing, ensuring that it remains unobtrusive during wear. The control module's design aligns seamlessly with the dressing's overall goal: to deliver continuous, non-invasive wound monitoring without compromising patient comfort.
[0057] The microprocessor within the control module is programmed to analyze data from the dressing's temperature, pH, and moisture sensors against predefined thresholds that correspond to normative ranges for healthy wound healing. These thresholds are set based on clinical standards, taking into account the typical parameters expected in the healing process. For example, a healthy wound is expected to maintain a stable temperature, a balanced pH level, and appropriate moisture content. When a sensor detects a deviation from these thresholds-such as a temperature rise indicating potential infection, or pH imbalances that could signal bacterial presence-the control module recognizes these trends as anomalies.
[0058] To perform these assessments, the control module continuously receives and processes data from each sensor in real time. Each sensor's data is routed to the microprocessor via ultrathin, flexible circuitry, which is printed directly onto a flexible substrate compatible with the dressing's breathable material. This circuitry serves as the conduit for data flow within the dressing, ensuring that information from the sensors is seamlessly relayed to the control module without adding any rigidity to the dressing's structure. Once the data is received, the microprocessor runs a comparative analysis, evaluating the real-time readings against stored normative thresholds. This process happens autonomously within the dressing, reducing dependency on manual inspection by healthcare providers and providing immediate, objective insights into the wound's condition.
[0059] When the control module detects an abnormal trend-such as a temperature spike beyond a safe threshold or unusual moisture levels that could hinder healing-it triggers an alert protocol. This protocol is programmed to initiate an immediate response by activating the dressing's wireless transmitter, which then sends a real-time notification to a secure, external healthcare platform. This notification is designed to include detailed information on the specific parameter that deviated, such as the exact temperature or pH level, enabling healthcare providers to assess the severity of the condition and respond promptly. The alert protocol is vital for early intervention, as it ensures that potential complications like infections or delayed healing are flagged at the earliest possible stage.
[0060] In addition to processing real-time data, the control module is equipped with an advanced algorithm capable of trend analysis. This allows the dressing to not only identify immediate deviations but also recognize gradual changes over time that may indicate emerging complications. For instance, a slow increase in temperature over several days could suggest inflammation that requires intervention, even if the temperature remains within an acceptable range for a single reading. The control module's ability to monitor and interpret these gradual changes provides a deeper layer of insight into the wound's healing trajectory, enhancing the precision and relevance of alerts.
[0061] The control module operates with minimal energy requirements, drawing power from the dressing's compact, disposable micro-battery. This battery is designed to provide consistent energy output to the control module, enabling continuous data processing throughout the dressing's single-use period. The energy efficiency of the control module is optimized through low-power microprocessor technology, which conserves battery life and allows for uninterrupted operation. This efficient energy consumption ensures that the dressing remains functional without the need for recharging, aligning with its disposable, patient-friendly design.

# Predefined threshold values for each parameter based on clinical standards
TEMPERATURE_THRESHOLD = 37.5 # Celsius, indicative of potential infection
PH_LOWER_THRESHOLD = 5.5 # pH level for healthy wound
PH_UPPER_THRESHOLD = 7.0 # Upper pH level before bacterial risk
MOISTURE_THRESHOLD = 0.6 # Relative scale for optimal wound hydration

# Time-based trend analysis parameters (e.g., tracking changes over last 5 readings)
TREND_HISTORY_SIZE = 5
TEMPERATURE_TREND_THRESHOLD = 0.5 # Trend threshold for gradual temperature increase
PH_TREND_THRESHOLD = 0.2 # pH trend change threshold
MOISTURE_TREND_THRESHOLD = 0.15 # Moisture change threshold for trend

# Initialize lists to hold sensor data for trend analysis
temperature_history = []
ph_history = []
moisture_history = []

def initialize_module():
"""
Initialize the control module. Could be used to calibrate sensors or
perform any initial checks before starting monitoring.
"""
print("Initializing control module...")
time.sleep(1)
print("Control module ready.")

def receive_sensor_data():
"""
Simulate receiving data from sensors. In real use, this function would collect data
directly from the dressing's sensors.
"""
temperature = np.random.normal(36.8, 0.2) # Simulate normal wound temperature
ph = np.random.uniform(5.5, 7.0) # Simulate healthy pH range
moisture = np.random.uniform(0.5, 0.7) # Simulate ideal moisture level
return temperature, ph, moisture

def check_thresholds(temperature, ph, moisture):
"""
Check if current sensor values exceed predefined thresholds and return alerts.
"""
alerts = []
if temperature > TEMPERATURE_THRESHOLD:
alerts.append("Temperature exceeds safe threshold - Possible infection")
if ph < PH_LOWER_THRESHOLD or ph > PH_UPPER_THRESHOLD:
alerts.append("pH level abnormal - Possible bacterial contamination or healing issue")
if moisture > MOISTURE_THRESHOLD:
alerts.append("Moisture level too high - Risk of maceration")
return alerts

def update_trend_history(sensor_history, new_value):
"""
Updates the trend history with new sensor data, maintaining a maximum size for history.
"""
sensor_history.append(new_value)
if len(sensor_history) > TREND_HISTORY_SIZE:
sensor_history.pop(0)

def check_trends():
"""
Analyze trends over time to detect gradual changes indicative of emerging complications.
"""
alerts = []
# Check temperature trend
if len(temperature_history) == TREND_HISTORY_SIZE:
temp_trend = temperature_history[-1] - temperature_history[0]
if temp_trend > TEMPERATURE_TREND_THRESHOLD:
alerts.append("Temperature trend rising - Possible developing infection")

# Check pH trend
if len(ph_history) == TREND_HISTORY_SIZE:
ph_trend = abs(ph_history[-1] - ph_history[0])
if ph_trend > PH_TREND_THRESHOLD:
alerts.append("pH trend abnormal - Possible bacterial activity or healing delay")

# Check moisture trend
if len(moisture_history) == TREND_HISTORY_SIZE:
moisture_trend = abs(moisture_history[-1] - moisture_history[0])
if moisture_trend > MOISTURE_TREND_THRESHOLD:
alerts.append("Moisture trend abnormal - Risk of improper healing environment")

return alerts

def trigger_alert(alerts):
"""
Trigger alerts by sending notifications through the wireless transmitter.
"""
for alert in alerts:
print(f"ALERT: {alert}")
# Placeholder for transmitting alerts to an external healthcare platform
# transmit_alert(alert)

def main():
"""
Main loop that simulates continuous monitoring and analysis.
"""
initialize_module()

while True:
temperature, ph, moisture = receive_sensor_data()

# Check current sensor readings against thresholds
immediate_alerts = check_thresholds(temperature, ph, moisture)

# Update trend histories for each sensor
update_trend_history(temperature_history, temperature)
update_trend_history(ph_history, ph)
update_trend_history(moisture_history, moisture)

# Check for trend-based alerts
trend_alerts = check_trends()

# Combine alerts and trigger if any detected
all_alerts = immediate_alerts + trend_alerts
if all_alerts:
trigger_alert(all_alerts)
[0062] The Smart Wound Dressing's control module operates by continuously monitoring temperature, pH, and moisture levels against set clinical thresholds, providing real-time analysis and alerting capabilities to ensure optimal wound care. Each of these threshold values-37.5°C for temperature, a pH range between 5.5 and 7.0, and a relative moisture level up to 0.6-has been carefully selected based on typical parameters associated with healthy wound healing. By setting these specific thresholds, the algorithm can quickly identify deviations that may indicate potential complications, such as infection, delayed healing, or bacterial contamination. For instance, a temperature rise beyond 37.5°C often correlates with infection, while abnormal pH levels suggest bacterial activity or an impaired healing response. By promptly detecting these changes, the control module enables early intervention, allowing healthcare providers to address issues before they worsen.
[0063] The temperature threshold helps in identifying early signs of inflammation or infection. The body's inflammatory response to infection typically elevates wound temperature, so detecting even a minor increase can provide critical information. Monitoring pH is equally essential, as it influences bacterial activity and tissue healing; wounds generally heal best within a balanced pH range, and deviations can indicate a compromised environment. Moisture levels play a pivotal role as well, as too much moisture can lead to maceration, while dryness can hinder cell migration needed for healing. The algorithm's moisture threshold ensures the dressing maintains an environment conducive to healthy healing.
[0064] The trend analysis component adds an additional layer of functionality by observing gradual changes over time, which might otherwise go unnoticed in single readings. By maintaining a history of recent values for each parameter, the algorithm identifies subtle trends, such as a slow but consistent temperature increase, which could indicate inflammation without breaching the immediate threshold. This feature is especially beneficial for chronic wound care, where long-term monitoring is required, as it ensures healthcare providers receive alerts about emerging issues early. With these layered monitoring capabilities, the algorithm significantly enhances wound care by providing accurate, continuous, and data-driven insights that reduce dependency on manual inspections, allowing for proactive, personalized care that aligns with each patient's unique healing trajectory.
[0065] Overall, the control module's integration within the dressing allows for autonomous, intelligent wound monitoring that combines sensitivity with accuracy. By serving as the processing core, the control module transforms raw sensor data into actionable insights, supporting timely, data-driven clinical decisions. Through this advanced processing capability, the Smart Wound Dressing delivers a sophisticated, next-generation wound care solution that elevates patient outcomes by minimizing the risks associated with delayed wound assessments and maximizing the opportunity for early intervention.
[0066] In terms of material composition, the dressing is crafted from biocompatible, hypoallergenic materials that form a multi-layered substrate, serving both as a protective barrier for the wound and as the medium for sensor integration. In direct contact with the wound, the dressing's primary layer is engineered to be breathable and moisture-wicking, allowing for natural airflow while ensuring that the sensors maintain a consistent interface with the wound surface. This layer's design facilitates accurate readings from the temperature, pH, and moisture sensors, each embedded within or adjacent to this layer, to optimize data fidelity. The sensors are integrated with advanced, miniaturized circuitry that ensures functionality without compromising the dressing's structural integrity or comfort, a critical feature for maintaining long-term wearability.
[0067] The material composition primarily consists of hypoallergenic polymers combined with advanced microfibers, which are carefully selected to create a multi-layered, flexible substrate. These polymers are treated to ensure skin compatibility, minimizing the risk of allergic reactions or irritation, making the dressing suitable for prolonged wear even on sensitive skin. By choosing biocompatible components, the dressing is optimized to interact naturally with the skin, avoiding the adverse effects that can arise from long-term exposure to conventional synthetic materials. The dressing's layered structure is also carefully calibrated to provide support for sensor integration without compromising overall comfort or flexibility.
[0068] The first layer, which comes in direct contact with the wound, is crafted from a breathable, moisture-wicking material that allows natural airflow while maintaining a stable interface with the wound. This layer is composed of a blend of hydrogel-coated microfibers that enable moisture management by absorbing excess exudate while still retaining enough moisture to support a balanced wound environment. The hydrogel within this layer promotes a cooling, soothing effect on the wound surface, which can alleviate discomfort and reduce inflammation. This layer's breathability is essential in preventing maceration, a common issue in traditional dressings that traps moisture, potentially slowing down healing. The material's microstructure also ensures a consistent sensor-to-wound interface, facilitating accurate and stable readings from the embedded sensors.
[0069] The middle layer of the dressing, which houses the sensors and conductive circuitry, is composed of a flexible polymer matrix designed to secure the sensors in place while preserving the dressing's adaptability. Advanced miniaturization techniques are used in this layer to embed the temperature, pH, and moisture sensors within the polymer matrix. The advanced miniaturization techniques used in the smart wound dressing involve a combination of microfabrication, thin-film deposition, and flexible electronics to integrate sensors and circuitry within the dressing material without adding bulk or compromising flexibility. These techniques allow the temperature, pH, and moisture sensors, along with their respective conductive pathways, to be embedded directly into the dressing's substrate, enabling seamless functionality and comfort for extended wear.
[0070] One key miniaturization technique is microfabrication, which involves creating ultra-small structures on the sensor surfaces using photolithography and etching. Photolithography, a technique borrowed from semiconductor manufacturing, uses a light-sensitive material (photoresist) to define intricate patterns on the dressing's polymer matrix, forming the base for sensor circuits. Chemical etching then removes unwanted material, leaving precisely crafted sensor arrays. Microfabrication is essential for reducing the size of each sensor and ensuring that they can operate within the dressing's thin, flexible layers without adding significant weight or rigidity.
[0071] Thin-film deposition is another crucial miniaturization technique. Thin layers of conductive metals, such as silver or gold, are deposited onto the flexible polymer matrix using methods like sputtering or chemical vapor deposition. This technique allows for the creation of conductive pathways only nanometers thick, which serve as connectors between the sensors and the control module. Thin-film deposition is instrumental in forming highly conductive yet flexible connections that enable reliable data transmission from the sensors without compromising the dressing's elasticity or breathability. Flexible electronics involve using stretchable and bendable materials, such as conductive inks or nano-patterned metals, that adapt to the natural movements of the skin. Printed electronics technology is employed to apply these materials onto the dressing substrate, creating ultra-thin, printed circuitry that can flex with the dressing. Conductive inks, which often contain silver nanoparticles or other conductive materials, are printed onto the dressing's surface to connect sensors to the control module without requiring traditional wiring. This type of flexible circuitry ensures that the dressing remains comfortable and functional, even on areas with high mobility, like joints.
[0072] Additionally, sensor embedding techniques, such as micro-embossing, are used to secure the miniaturized sensors within the dressing material without disrupting its structure. In micro-embossing, small cavities or recesses are created in the polymer matrix, into which each sensor is placed. Once embedded, the sensors are sealed with thin adhesive or polymer coatings, preserving the dressing's smooth surface while keeping the sensors in close contact with the wound. These miniaturization techniques collectively enable the creation of a smart wound dressing that combines high functionality with low profile, comfort, and flexibility.
[0073] Each sensor is integrated with micro-circuitry, using thin-film conductive materials such as silver or gold nanoparticles printed directly onto the polymer surface. These conductive pathways link each sensor to the control module, ensuring a stable data flow without adding bulk to the dressing. The flexibility of the polymer matrix allows the dressing to conform closely to the contours of the body, making it suitable for use on joints or other areas where movement might otherwise compromise adhesion or comfort. This layer effectively serves as the infrastructure for data transmission, integrating all components into a cohesive system while maintaining the integrity of the dressing's structure.
[0074] The outermost layer provides structural support and acts as a barrier to external contaminants, safeguarding the wound from potential infection. This layer is made from a biocompatible polyurethane film that is both waterproof and permeable to gases, allowing oxygen to reach the wound while blocking harmful pathogens. This layer's high tensile strength helps maintain the dressing's form, making it resistant to tearing or damage from daily activities. In addition to providing protection, this layer also ensures that the sensors and internal circuitry remain undisturbed by external forces, preserving their functionality over the dressing's wear period.
[0075] The manufacturing process for this smart wound dressing involves a series of layering, printing, and coating steps to ensure precise integration of sensors within the dressing material. First, the primary layer is created by casting the hydrogel-coated microfiber substrate onto a breathable polymer sheet. This base layer is then laminated with the flexible polymer matrix, into which sensors and conductive pathways have been embedded using micro-printing techniques. Thin-film deposition methods are employed to secure the sensors onto this layer, creating a stable yet flexible connection to the central control module. The outer layer of polyurethane film is finally applied using heat-activated adhesives that bond the layers without affecting the embedded sensors. This multi-step process preserves the dressing's functionality while ensuring it remains lightweight, breathable, and suitable for extended wear. To support the dressing's single-use design, an embedded, disposable power source provides sufficient energy for the duration of the dressing's use. This battery is compact and safe for skin contact, with a low-profile design complements the dressing's overall unobtrusiveness. It is engineered to power both the sensors and the wireless transmitter efficiently, allowing the apparatus to remain active for the entirety of the dressing's intended wear period. The power source is strategically positioned within the dressing to minimize bulk and prevent interference with sensor operation or data transmission, ensuring consistent monitoring throughout its usage.
[0076] This micro-battery is typically composed of thin-film lithium chemistry, chosen for its high energy density and ability to deliver a steady voltage output over the device's lifespan. Thin-film lithium batteries are not only lightweight but also capable of maintaining stable performance in a small, compact form factor. The battery's outer layer is made from biocompatible materials, often a medical-grade polymer, ensuring it is skin-safe and minimizing the risk of irritation. This encapsulation layer also protects the battery from exposure to moisture or wound exudate, preserving its integrity and preventing any potential contamination of the wound. The biocompatible coating allows the battery to be embedded in the dressing close to the wound site without posing any health risks, enabling seamless integration with the dressing's other components.
[0077] In terms of design, the battery has a low-profile structure, often less than a millimeter thick, which allows it to be positioned strategically along the edge of the dressing, away from the wound contact area. This placement minimizes any interference with the sensors or the wound environment while ensuring easy access for power connections to the sensors, control module, and transmitter. By situating the battery in a non-intrusive location, the dressing can maintain a comfortable fit and flexibility, critical for applications where the dressing may be worn for extended periods.
[0078] The disposable power source is carefully calibrated to match the dressing's energy requirements for its full usage period, ensuring that each component receives consistent power. This power management is crucial for the sensors, which require precise voltage regulation to maintain accuracy in reading temperature, pH, and moisture levels. The battery's steady output guarantees that these sensors can operate reliably throughout the dressing's wear time without experiencing fluctuations that could impact data fidelity. The control module, which processes data in real time and initiates alerts, also relies on the battery's consistent energy delivery to ensure responsive and autonomous wound monitoring.
[0079] The power source also plays a crucial role in supporting the wireless transmitter, which operates on a low-energy communication protocol to preserve battery life. While the transmitter periodically transmits data to an external healthcare platform, it can increase its transmission frequency if the sensors detect abnormal readings, making power efficiency vital. The battery's capacity is specifically selected to support these occasional power surges, enabling reliable transmission without exhausting the power supply prematurely. This design consideration is essential for real-time wound monitoring, as it allows healthcare providers to receive timely updates on the wound's status, particularly when deviations in healing parameters are detected.
[0080] The interaction between these components forms a cohesive apparatus that transforms traditional wound care. The sensors continuously gather data, which the control module processes in real time, checking against preset thresholds and initiating alerts through the transmitter when deviations are detected. This seamless integration of components allows the dressing to operate autonomously, requiring no external intervention from the patient while ensuring that healthcare providers remain informed of the wound's healing status. The apparatus's intelligent design ensures that each component contributes to a specific monitoring function while collectively supporting the device's primary goal of providing reliable, continuous wound assessment in a non-invasive, patient-friendly format. Through this intricate arrangement of components, the Smart Wound Dressing effectively redefines the standard of care in wound monitoring, facilitating enhanced accuracy, early intervention, and superior patient outcomes.
[0081] The Smart Wound Dressing upon application, in direct contact with the wound surface, the dressing's micro-sensors begin to capture critical data, specifically measuring temperature, pH levels, and moisture content. These parameters are selected due to their strong correlation with wound healing status; temperature spikes, for example, may indicate the onset of infection, while fluctuations in pH and moisture levels can reveal other abnormalities in the wound healing process. Each sensor is calibrated for precision, ensuring that even slight changes in the wound's environment are detected promptly. Once data is collected, it is processed by an integrated control module, which acts as the apparatus's analytical core. The control module compares the sensor data against preset thresholds corresponding to normative healing ranges. If data from any sensor deviates beyond these thresholds, the control module identifies this as an abnormal trend, indicative of a potential complication, such as infection or delayed wound healing. The control module's processing capability enables autonomous decision-making, allowing the dressing to assess wound conditions in real time without requiring external input or manual inspection. This feature is crucial for patients who may lack immediate access to healthcare facilities, as it enables prompt recognition of complications directly from the dressing.
[0082] Upon detecting an abnormality, the control module triggers an alert protocol within the dressing's wireless transmitter. The transmitter, positioned discreetly along the dressing's edge, initiates a secure data transmission to the healthcare provider's monitoring platform. This data transmission protocol is configured to prioritize reliability and security, ensuring that sensitive patient information is transmitted without risk of interference or unauthorized access. The healthcare platform, designed as a secure, cloud-based interface, receives the data and alerts the healthcare provider via automated notifications. These alerts can be customized to deliver detailed information regarding the specific parameter in deviation, such as an elevated temperature or abnormal pH level, allowing providers to make informed, timely decisions about intervention strategies. Simultaneously, the dressing continues to monitor the wound environment, gathering data at regular intervals or based on preset schedules. This continuous monitoring cycle is sustained by a compact, integrated power source that ensures sufficient energy for the duration of the dressing's single-use period. The power source is engineered to support the sensors, control module, and transmitter efficiently, allowing uninterrupted operation throughout its usage. Maintaining a steady power supply guarantees reliable, continuous assessment without requiring recharging, which would otherwise disrupt the device's function or interfere with patient care.
[0083] The healthcare provider accesses the wound data through an intuitive, data-driven dashboard that presents real-time and historical data, trend analysis, and any deviations that trigger alerts. This apparatus's design enables providers to track the wound's healing progression over time, assessing whether healing is progressing as expected or if adjustments to treatment are required. The platform also allows for personalized threshold settings, permitting healthcare providers to adjust alert sensitivity based on the unique requirements of each patient's condition, thereby refining the relevance of alerts and supporting customized patient care. In its entirety, the Smart Wound Dressing operates as an integrated, autonomous monitoring apparatus, continuously assessing wound health and transmitting data to healthcare providers for proactive, data-driven interventions. Each component, from the micro-sensors to the transmitter, is configured to interact seamlessly, supporting a cohesive workflow that prioritizes patient comfort and healthcare efficiency. This apparatus represents a transformative approach to wound management, eliminating the need for frequent manual assessments, enhancing the accuracy of wound monitoring, and providing early warnings of complications. The dressing significantly improves patient outcomes by combining real-time data collection, secure transmission, and automated alerts, facilitating a new standard in continuous, non-invasive wound care.
[0084] Case Study Example: A diabetic patient with a chronic foot ulcer is fitted with the Smart Wound Dressing with Integrated Temperature, pH, and Moisture Sensors. Initially, the wound shows stable parameters within the normal healing range, as indicated by baseline measurements recorded by the dressing. These values are monitored and transmitted regularly to the healthcare provider's platform, allowing for continuous assessment without requiring frequent in-person visits, which are particularly burdensome for this patient due to limited mobility.
[0085] After several days of monitoring, the dressing's temperature sensor detects a gradual but steady rise in temperature around the wound site, deviating from the patient's established baseline. This increase in temperature suggests a potential infection. Concurrently, the pH sensor records a shift towards acidity, another indicator of inflammatory response. Upon processing this data, the dressing's control module flags these trends as abnormal and triggers an alert through the integrated wireless transmitter. A notification is immediately sent to the healthcare provider's secure platform, detailing the abnormal temperature and pH values along with the timestamped data showing the deviation over time.
[0086] The healthcare provider, alerted in real-time, promptly reviews the data remotely and arranges an early intervention. Following this early detection, the patient's treatment is adjusted to include targeted antibiotics and wound care modifications aimed at addressing the infection before it escalates. The timely response prevents further complications, and subsequent data transmitted by the dressing indicates a return to normal parameters, affirming the effectiveness of the intervention. This case exemplifies how the Smart Wound Dressing's continuous, real-time monitoring and alert apparatus can proactively detect complications, enabling swift, data-informed medical responses that enhance patient outcomes and prevent prolonged, severe infections.
[0087] While there has been illustrated and described embodiments of the present invention, those of ordinary skill in the art, to be understood that various changes may be made to these embodiments without departing from the principles and spirit of the present invention, modifications, substitutions and modifications, the scope of the invention being indicated by the appended claims and their equivalents.





FIGURE DESCRIPTION

[0088] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate an exemplary embodiment and explain the disclosed embodiment together with the description. The left and rightmost digit(s) of a reference number identifies the figure in which the reference number first appears in the figures. The same numbers are used throughout the figures to reference like features and components. Some embodiments of the Apparatus and methods of an embodiment of the present subject matter are now described, by way of example only, and concerning the accompanying figures, in which:

[0089] Figure - 1 illustrates the line diagram of the dressing apparatus where the primary wound-contact layer, positioned closest to the wound, is crafted from a breathable and hypoallergenic material. This layer serves as the interface between the wound and the dressing, allowing air to flow naturally to the wound site. This airflow prevents moisture buildup that could lead to maceration and ensures that the dressing remains gentle on the skin, even with prolonged use. The hypoallergenic properties of this layer also help reduce irritation, providing a comfortable and stable foundation for continuous wound care. The temperature sensor is embedded directly within this primary layer, as close as possible to the wound surface. This position allows the temperature sensor to detect even minor fluctuations in the wound's heat levels, which can signal potential inflammation or infection. By capturing these changes, the temperature sensor provides early indications of complications, enabling healthcare providers to address issues promptly and minimize potential risks associated with temperature variations. Above the temperature sensor is the pH sensor, which is carefully positioned to monitor the wound's biochemical environment. This sensor detects changes in the wound's pH level, a crucial indicator of bacterial activity or compromised healing. Deviations from the normative pH range often signify infection or delayed healing, making this sensor essential for assessing the wound's health status. The pH sensor's proximity to the wound ensures it captures accurate data in real time, providing healthcare providers with insight into any infection risks. Higher up in the dressing structure lies the moisture sensor, specifically positioned to monitor hydration levels within the wound environment without interference from the other sensors. By continuously assessing moisture content, this sensor helps maintain optimal hydration levels, preventing both excessive dryness that can hinder healing and excess moisture that may damage surrounding skin. The sensor's placement ensures it can measure wound hydration accurately, contributing to a balanced healing environment. The control module, located near the dressing's edge, serves as the central processing hub for data collected from each sensor. This microprocessor-based module evaluates real-time sensor readings against clinically established thresholds, identifying any abnormal patterns in wound healing. When the control module detects deviations or concerning trends, it triggers an alert, prompting the wireless transmitter to send notifications to healthcare providers. This autonomous processing capability allows the control module to support proactive, data-driven wound care with minimal manual intervention. The low-energy wireless transmitter is discreetly placed along the dressing's edge, away from the wound contact area, to maintain sterility and ensure uninterrupted data transmission. This transmitter relays the processed data to an external healthcare platform, where providers can remotely monitor the wound's healing status. Its edge placement also prevents interference with the dressing's adherence to the wound site, ensuring the dressing remains secure and comfortable during daily activities.The thin-film lithium battery, positioned away from the wound, powers the sensors, control module, and wireless transmitter. This power source is carefully placed to avoid contact with the wound and to minimize bulk within the dressing. Its steady energy output allows for continuous operation of all components throughout the dressing's wear period, eliminating the need for recharging. The battery's low-profile design ensures that it supports the dressing's single-use structure, enabling seamless and uninterrupted monitoring for the duration of wound care. , Claims:1. A smart wound dressing apparatus for Continuous, Non-Invasive, Real-Time Wound Healing Monitoring, comprising:
a multi-layered, biocompatible substrate dressing to conform to a wound site, each layer engineered to optimize sensor integration and maintain patient comfort during prolonged use;
a plurality of micro-sensors embedded within said substrate, including a temperature sensor, a pH sensor, and a moisture sensor, each calibrated to monitor wound healing parameters in real time and positioned to maintain direct contact with the wound surface;
a control module integrated within said substrate, said control module comprising a microprocessor programmed to analyze sensor data in real time, wherein said analysis includes comparison of data against preset thresholds corresponding to normative wound healing parameters, and wherein said control module is further configured to autonomously identify abnormal trends in wound healing based on said sensor data;
a wireless transmitter positioned within said substrate and operatively connected to said control module, said transmitter configured to transmit processed sensor data to an external healthcare platform via a low-energy communication protocol, thereby enabling remote monitoring of wound conditions;
a disposable, integrated power source embedded within said substrate, said power source being a thin-film battery configured to provide consistent energy to said micro-sensors, control module, and wireless transmitter for the duration of the dressing's intended single-use period, and positioned to avoid interference with wound contact;
wherein said apparatus is configured to autonomously monitor wound healing parameters, transmit data, and initiate alerts upon detection of abnormal healing trends, facilitating continuous, non-invasive wound monitoring.
2. The apparatus of claim 1, wherein said multi-layered, biocompatible substrate comprises an inner layer in direct contact with the wound, made from a breathable, moisture-wicking material incorporating hydrogel-coated microfibers to maintain optimal moisture levels, promote airflow, and provide a consistent interface with said micro-sensors, thereby preventing maceration and optimizing the wound environment.
3. The apparatus of claim 1, wherein said micro-sensors further comprise a thermistor or thermocouple as said temperature sensor, configured to detect fluctuations in wound temperature indicative of infection or inflammation, an ion-sensitive field-effect transistor (ISFET) or pH-sensitive hydrogel as said pH sensor, configured to detect deviations in pH levels from a normative healing range, wherein said deviations signal potential bacterial contamination or delayed healing and a capacitive or resistive sensor as said moisture sensor, configured to measure wound hydration levels and signal conditions of either excess moisture or desiccation, which may hinder healing.
4. The apparatus of claim 1, wherein said micro-sensors are arranged within said substrate in a layered configuration such that the temperature sensor is positioned closest to the wound surface, followed by the pH sensor, with the moisture sensor positioned above both, thereby ensuring each sensor maintains optimal, unobstructed contact with the wound environment.
5. The apparatus of claim 1, wherein said control module comprises a mechanism for trend analysis that assesses gradual changes in sensor data over a predefined period to detect emerging complications in wound healing, wherein said algorithm is configured to trigger an alert based on gradual trends in temperature, pH, or moisture levels, even when immediate thresholds are not exceeded.
6. The apparatus of claim 1, wherein said wireless transmitter is configured to transmit data at set intervals or in response to detection of abnormal trends, and wherein said transmitter employs an energy-efficient communication protocol selected from the group consisting of Bluetooth Low Energy (BLE) and Zigbee, thereby minimizing power consumption.
7. The apparatus of claim 1, wherein said disposable, integrated power source is a thin-film lithium battery comprising a biocompatible encapsulation layer to ensure safety during skin contact and to prevent exposure to wound exudate, thereby maintaining device integrity and minimizing irritation risk.

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