Smart post-liposuction compression garment with embolism detection and mobile monitoring system
The smart compression garment with integrated sensors and closed-loop control addresses the limitations of conventional garments by providing continuous monitoring and targeted prophylaxis, enhancing early detection and prevention of postoperative complications.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-09-13
- Publication Date
- 2026-03-26
AI Technical Summary
Conventional compression garments for post-liposuction patients lack continuous monitoring of vital signs, fail to provide fine-grained pressure mapping, and lack closed-loop control for therapeutic dosing, leading to delayed detection of postoperative complications such as deep vein thrombosis and pulmonary embolism.
A smart compression garment with integrated sensors for vital sign monitoring, a closed-loop compression module, and local drug delivery system to provide targeted prophylaxis, along with predictive analytics for early detection and intervention.
Enables timely detection and prevention of postoperative complications by dynamically adjusting compression and providing site-specific therapeutic interventions, reducing hospital readmissions and improving recovery outcomes.
Smart Images

Figure IB2025059215_26032026_PF_FP_ABST
Abstract
Description
DescriptionTitle of Invention : Smart Post-Liposuction Compression Garment with Embolism Detection and Mobile Monitoring System |Technical Field
[0001] This invention relates to the field of postoperative medical devices and patient monitoring systems. More particularly, it pertains to a wearable compression garment for post-liposuction patients that integrates physiological sensors and alert mechanisms to detect potential embolism or other post-surgical complications, with data connectivity to a mobile application for real-time health monitoring and alerts.Background Art
[0002] Liposuction is a common surgical procedure in which fat is removed from the body. After liposuction, patients are typically required to wear compression garments for several weeks to reduce swelling, improve circulation, and support healing of the treated areas. These post-liposuction compression garments apply continuous, uniform pressure to tissues, aiding recovery and comfort. However, despite wearing compression attire, patients remain at risk of serious postoperative complications such as deep vein thrombosis or fat embolism that can lead to pulmonary embolism. A pulmonary embolism (an obstruction of blood flow in the lungs, often due to a blood clot or fat globule) can be life-threatening if not detected immediately. Signs of such an embolism may include sudden changes in vital signs: for instance, a drop in blood oxygen saturation, rapid or irregular heart rate, slowed or arrested breathing, or a prolonged lack of movement (suggesting unconsciousness or collapse). In the at-home recovery setting, these signs can easily go unnoticed until the patient is in critical condition. Continuous monitoring of vital indicators could facilitate early detection of these dangerous events, enabling timely medical intervention. Yet, traditionally, once the patient leaves the clinic, there is minimal active monitoring aside from the patient’s subjective awareness of symptoms or periodic check-ins. There exists a need for a smart garment system that not only provides the necessary post- surgical compression but also keeps a vigilant watch on the patient’s vital signsand immediately alerts both the patient and caregivers to any warning signs of embolism or other complications.
[0003] Some prior attempts have been made to monitor post-surgical patients remotely, but they do not adequately address the specific needs of liposuction recovery or provide the integrated features of the present invention. For example, US20230181121 describes systems and methods for managing and predicting post-surgical recovery broadly. This prior art recognizes the importance of tracking various physiological data after surgery - including ECG (heart activity), blood oxygenation, pulse rate, and activity levels - and even uses predictive models (potentially Al-driven) to assess patient recovery. However, US20230181121 focuses on data collection and analysis for general postoperative care and outcome prediction, rather than on a dedicated wearable garment that actively alerts to acute emergencies. It does not specifically teach a compression garment designed for post-liposuction patients, nor does it emphasize an on-body alert mechanism for immediate response to critical events.
[0004] Another relevant document, The PCT Pat. Application No.WO2022108712, addresses real-time monitoring of patients at risk of respiratory or oxygenation emergencies in out-of-hospital settings. The said document discloses a wearable device (in one embodiment a multi-layer thoracic garment) containing optical oxygen sensors and other biosensors, with a control logic that can switch from a resting mode to an alarm state when a high-risk condition is detected. That system is principally aimed at conditions such as opioid overdose, asthma attacks, or seizures, where continuous pulse oximetry and respiratory monitoring can trigger an alert (e.g., via a speaker) if the patient’s oxygen level or breathing becomes dangerously abnormal. While WO2022108712 demonstrates the general concept of a wearable health monitor with alarm capabilities, it differs from the present invention in scope and application. It is not specifically integrated into a post-surgical compression garment, nor is it tailored to the context of cosmetic surgery recoveries like liposuction.Summary of Invention
[0005] The summary of disclosed invention is intended to provide an overview of the subject matter of the invention, and is not intended to identify essential elementsor key elements of the subject matter, nor is it intended to be used to determine the scope of the claimed implementations.
[0006] The smart post-liposuction compression garment integrates advanced medical enhancements to improve patient safety and recovery through real-time monitoring and therapeutic intervention.
[0007] The smart post-liposuction compression garment is designed as a suit or wrap, such as an abdominal binder for localized procedures or a full-torso bodysuit covering shoulders to legs, made from stretchable, biocompatible fabric. It delivers 20-30 mmHg of compression, adhering to medical guidelines, and features reinforced seams and closures (e.g., zippers or hook-and-eye fasteners) for easy donning and doffing, accommodating limited post-surgical mobility. The garment’s interior is smooth, non-irritating, and may include moisture-wicking layers for comfort during extended wear. Integrated sensors, either woven into the fabric or attached as flexible modules, monitor vital signs critical for embolism detection. A pulse oximetry sensor, using reflective photoplethysmography with red and infrared LEDs, measures heart rate and blood oxygen saturation (SpO2) from the chest, flank, or via a finger / earlobe clip, computing data continuously or at intervals. Respiratory rate is tracked via an elastic strain gauge, piezoelectric sensor, impedance pneumography, or accelerometer, detecting chest or abdominal movements to assess breathing patterns and identify apnea. A 3-axis accelerometer-based inertial measurement unit monitors motion and posture, distinguishing activity from prolonged stillness, which may indicate unconsciousness, while filtering motion artifacts from other signals. Optional sensors, like thermistors for temperature or inflatable cuffs for blood pressure, can be added, though the focus remains on heart rate, SpO2, respiration, and mobility. Low-profile, flexible sensor components and insulated conductive tracks ensure comfort, with wiring routed through garment channels. A detachable control module, roughly the size of a matchbox, is positioned on the torso or hip for minimal interference. It houses a microcontroller for real-time sensor data processing, a Bluetooth Low Energy chip for mobile device connectivity, a rechargeable battery, a vibration motor or buzzer for alerts, and optional status LEDs. The module snaps into a docking connector, allowing removal for chargingor laundering, with washable sensor connections achieved through waterproofing or detachable units.
[0008] A network of miniature pneumatic micro-bladders, embedded along the calf, thigh, and abdominal regions, cyclically inflates and deflates at a preset pressure, such as 45 mmHg, when the onboard Al or rule-based logic detects elevated embolism risk from sustained immobility, rising D-dimer levels, low SpO2, or tachycardia suggesting venous stasis. This mimics the calf-muscle pump action to promote venous return and reduce clot formation, providing a closed-loop therapeutic intervention not explicitly taught in prior art for post-liposuction garments. A disposable biochemical sensing patch, positioned on the lateral thigh or wrist, houses a microfluidic chamber paired with a paper-based immunoassay strip, such as a colorimetric D-dimer test, to periodically analyze micro-lacrimal or sweat samples every four hours. If D-dimer or related fibrin degradation products exceed a programmable threshold, the on-garment electronics receive a digital high-risk flag, elevating alert priority and potentially adjusting micro-bladder action when combined with vital sign anomalies, offering a novel integration of real-time coagulation monitoring specific to post-liposuction patients.
[0009] A grid of thin, flexible pressure sensors, either resistive or capacitive, laminated across the garment’s inner surface continuously measures local pressure distribution to verify that therapeutic compression of 20-30 mmHg is maintained uniformly across treated sites like the abdomen, flanks, and thighs. If pressure falls outside the surgeon-set range due to a loose strap or malposition, the patient receives an immediate haptic alert and a mobile app message with instructions to re-don the garment properly, while long-term compliance statistics, such as wear time and average pressure, are logged for surgeon review, adding a novel patient-compliance and quality-control layer. A miniature transcutaneous sensor, either electrochemical or optical, placed beneath the chest portion of the garment measures transcutaneous partial pressures of CO2(TcPCO2) and O2(TCPO2) through the skin. A sudden rise in TcPCO2, indicative of hypoventilation, combined with an SpO2drop triggers a Tier II alarm for early respiratory compromise, while a TcPO2decline over the abdominal liposuction site flags compromised perfusion or early necrosis, enhancing detection sensitivity beyond standard PPG-based SpO2monitoring.
[0010] An array of flexible, adhesive resistive or impedance-based sensors overlays each incision or scar zone to monitor micro-stretch and skin impedance changes, detecting seroma formation, early hematoma, or wound dehiscence. If local impedance rises above a set threshold or excessive tension indicates swelling, the system sends a localized prompt, such as “Excessive fluid accumulation at incision — elevate area and notify surgical team,” extending the garment’s scope to wound-site surveillance. A secure, embedded Neural Processing Unit (NPU) in the control module or a companion cloud-based server continuously fuses data from all sensors, including vitals, Doppler flow, biochemical D-dimer, pressure mapping, TcPCO2 / TcPO2, and incision impedance, to compute a multidimensional risk index. Employing deep learning models, such as lightweight CNN or LSTM, trained on pre-collected postoperative datasets, the system generates early warnings up to 6-12 hours before critical thresholds are reached, predicting complications like SpO2drops based on subtle TcPCO2drift and declining venous flow, improving specificity and reducing false positives common in threshold-based alarms.
[0011] The control unit supports a secure firmware stack with HL7 / FHIR protocols over BLE or LTE, automatically transmitting encrypted summary packets containing vitals history, risk scores, and device logs to a hospital’s EMR system or tele-ICU dashboard upon detection of Tier I vital sign threshold events or Tier II predictive risk events, enabling real-time remote monitoring of multiple postoperative patients and bridging the gap between wearable data and clinical informatics systems. A companion augmented reality (AR) app for smartphones or smart glasses enhances patient recovery by providing visual overlays when sensor combinations indicate early DVT risk, such as rising D-dimer, venous stasis, and borderline SpO2, guiding patients through leg-elevation maneuvers or gentle ankle pumps. If incision integrity sensors flag potential seroma, the AR overlay highlights specific areas for applying gentle compression or positioning to manage fluid accumulation, as instructed by the surgical team, ensuring patients receive interactive, real-time guidance to respond effectively in 3D space.Technical Problem
[0012] Prior compression garments and intermittent pneumatic compression devices suffer from limited patient compliance due to poor breathability and thermalcomfort, provide only coarse or intermittent physiological monitoring (pressure or motion only), fail to continuously monitor hemodynamic and biochemical markers of thrombotic risk, lack fine-grained pressure mapping and closed-loop control to ensure therapeutic dosing at all anatomical sites, and are not configured for targeted, on-demand local pharmacologic delivery triggered by real-time diagnostics. Moreover, many monitoring modalities require bulky consoles or heating elements, preventing comfortable continuous wear, and existing systems lack integrated predictive analytics and clinical interoperability for remote escalation. These limitations delay early detection of postoperative complications, delay targeted therapy, and reduce real-world efficacy of prophylactic compressionAdvantageous Effects of Invention
[0013] The present invention provides a smart postoperative garment system which, by integrating multiple synergistic sensing, actuation, and therapeutic modules, delivers significant clinical and operational benefits over conventional monitoring or compression devices. In particular, the closed-loop compression module dynamically adjusts inflation and deflation in response to early indicators of venous stasis or hypoxia, enabling timely prophylaxis against deep vein thrombosis (DVT) and related circulatory complications without requiring manual clinician intervention.
[0014] Embedded microfluidic D-dimer and coagulation marker testing allows for real-time identification of hypercoagulable states, facilitating earlier diagnosis and treatment initiation compared to standard laboratory testing protocols.
[0015] The Doppler-echo patch provides uninterrupted venous flow velocity measurements, uniquely extending such monitoring capabilities to wearable systems for liposuction recovery patients, thus addressing a previously unmet need in postoperative surveillance.
[0016] On-demand local release of anticoagulants such as heparin or aspirin, triggered by sensor fusion algorithms, offers site-specific therapeutic dosing, potentially reducing systemic drug exposure and associated side effects.
[0017] The pressure-mapping compliance feedback system ensures that therapeutic compression levels are maintained and automatically alerts the patient in theevent of suboptimal pressure, improving therapeutic efficacy and patient adherence.
[0018] Integrated transcutaneous gas exchange monitoring facilitates early recognition of hypoventilation or hypoxia, allowing rapid corrective measures to prevent respiratory weakening.
[0019] The incision site integrity array detects seroma formation, hematoma, or wound dehiscence at each liposuction port, enabling fast corrective action and reducing the risk of infection or revision surgery.
[0020] The multimodal predictive Al hub fuses data from all sensing modalities, employing deep learning algorithms to forecast complications before they become clinically apparent, thereby enhancing patient safety and outcomes.
[0021] The AR-guided assistance feature provides patients with interactive, three- dimensional recovery instructions tailored to detected risks, improving compliance with protocols and empowering patients in their own recovery process.
[0022] Together, these features enable a shift from passive monitoring toward active, intelligent, and personalized postoperative care. By simultaneously addressing circulatory, respiratory, and wound-healing parameters while enabling remote, automated intervention, the invention substantially improves complication prevention, reduces hospital readmissions, and enhances overall recovery outcomes compared to prior art solutions.Brief Description of Drawings
[0023] [The figures of the present document are intended to be illustrative, not limiting.
[0024] Fig.1 shows an overall view of garment with its apparent components.
[0025] Fig.2 shows the control module which integrates a microcontroller or microprocessor with analog-to-digital converters.
[0026] Fig.3 shows the local drug delivery reservoir system featuring disposable drug reservoirs with a biodegradable polymer-based microporous matrix with a transdermal microneedle array.
[0027] Fig.4 shows the pressure monitoring system comprises a grid of thin, flexible pressure sensors.
[0028] Fig. 5 shows the schematic view of the electrodes of transcutaneous gas exchange monitoring system.
[0029] Fig. 6 shows a schematic view of a Doppler-echo micro-ultrasound patch.
[0030] Fig. 7 shows a schematic view of relation of drug delivery system with other part of garmebts. ]Description of Embodiments
[0031] Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:
[0032] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term “a” or “an” used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein.
[0033] The compression garment described hereinafter can be in the form of a suit or wrap covering the regions of the body treated by liposuction. For example, in abdominal liposuction cases, the garment may be a snug abdominal binder or vest; in a full-torso liposuction case, a bodysuit covering the shoulders down to the legs (similar to the garment illustrated in Figure 1 ) can be used. The garment is made of a stretchable, biocompatible fabric (such as a nylon-Spandex® blend) that provides the necessary compression (typically ranging from 20-30 mmHg of pressure, as per medical guidelines) to the patient’s body. The design of the garment includes reinforced seams and convenient closures (like zippers or hook-and-eye fasteners along the front) for ease of donning and doffing, since patients often have limited mobility immediately after surgery. The interior of the garment has smooth, non-irritating surfaces and may include moisture-wicking layers to ensure comfort during extended wear.
[0034] Integration of Sensors: The sensors are either woven into the fabric or attached via small, flexible modules at strategic locations where they can reliably capture data:
[0035] Heart Rate and Blood Oxygen Sensor: A pulse oximetry sensor is integrated to measure both heart rate and oxygen saturation (SpO2). This could be a reflective photoplethysmographic (PPG) sensor placed inside the garment against a well-perfused area of skin. In one embodiment, the sensor is located in the chest or flank area of the garment where it can detect pulsatile blood flow; in another embodiment, the garment includes a small sleeve for a finger or an earlobe clip (tethered by a thin wire) to measure SpO2similarly to a hospital pulse oximeter. The sensor consists of a pair of light emitters (red and infrared LEDs) and a photodetector. It may be encased in a small flexible pod that is sewn into the garment’s inner surface so that it maintains gentle contact with the skin. From the photoplethysmogram, the system can compute the patient’s pulse rate and blood oxygen level continuously or at set intervals (e.g., every few seconds).
[0036] To monitor breathing, the garment employs a respiration sensor or respiratory rate sensor(3). In one application, this is achieved by an elastic strain gauge or piezoelectric sensor embedded around the waist or stomach or chest region of the garment. As the patient breathes, the expansion and contraction of the chest or abdominal circumference create measurable changes in the sensor’s output. The control module(5) reads these changes to determine the respiratory rate and, to some extent, the breathing pattern (normal, shallow, irregular, or absent). Another implementation uses an impedance pneumography approach, where two or more conductive fabric electrodes are placed on the garment (spaced apart on the torso) to measure changes in the body’s electrical impedance as the lungs fill and empty with air. This impedance change associates with breathing effort. The garment could also house an accelerometer-based breath sensor (by analyzing slight vertical motions of the chest during inhalation / exhalation). The chosen method provides continuous tracking of breathing rate and can detect apnea (cessation of breathing) rapidly.
[0037] An inertial measurement unit (IMU), consisting of a 3-axis accelerometer (and optionally a gyroscope) acts as motion and posture sensors, is integrated into the control module(5) or another stable part of the garment. This sensor tracks the patient’s movement and orientation. From the accelerometer data, the system can determine if the patient is active (walking or moving), changing posture, or if they have remained still for a prolonged period. Lack of motion over a concerningduration (e.g., no significant movement for an hour during waking hours) could indicate the patient has fallen asleep or become unconscious. Conversely, normal movement patterns provide reassurance that the patient is conscious and mobile, reducing false alarms. The motion sensor(4) data can also help filter out motion artifacts from the heart rate or respiration signals (for example, the system can recognize when signal noise is due to sudden movement and avoid a false alarm).
[0038] The garment’s design allows inclusion of further sensors if needed. For instance, a temperature sensor (such as a small thermistor or digital thermometer) could be added to track body temperature for fever (which might indicate infection or other complications). A blood pressure sensor might be implemented via an inflatable bladder or cuff integrated into the garment for periodic measurements, though this adds complexity and is considered optional. The focus of the current invention is on the core vital signs related to embolism detection: heart rate, oxygen saturation, respiratory rate, and patient mobility, but the platform is extensible.
[0039] All sensor components are chosen to be low-profile and flexible, so they do not protrude or cause discomfort under the compression garment. Where wiring is needed, it is achieved with flexible conductive tracks either printed on the fabric or sewn in as conductive threads, insulated and flattened to avoid any pressure points on the body. The garment may have small built-in channels or pockets to route and protect these connections leading to the control module(5).
[0040] A central electronic control unit(5) is attached to the garment, housing the processing and communication electronics. This module is about the size of a small matchbox or credit card, with a thin form factor, and is typically located on an accessible part of the garment (for example, along the side of the torso near the lower ribs or hip) where it will not interfere with the patient’s comfort. Often it is placed over an area not directly under high compression, or in a slight pocket in the garment. As shown in Fig. 2, the control module(5) comprises:
[0041] a microcontroller or microprocessor with analog-to-digital converters to gather data from the sensors;
[0042] firmware programmed to analyze the incoming sensor signals in real time;
[0043] a Bluetooth Low Energy (BLE) or similar wireless communication chip to send data to the external mobile device;
[0044] a small rechargeable battery to power the system (for instance, a flat lithiumpolymer cell that can be recharged via a micro-USB / USB-C port or a wireless charging pad);
[0045] a vibration motor (like those used in cell phones, e.g. a coin or cylindrical eccentric mass motor) and / or a miniature speaker / buzzer for audible alerts;
[0046] optional indicator lights (LEDs) to show device status (such as power on, Bluetooth connected, low battery, etc.).
[0047] The control module(5) is designed to be removable from the garment for charging and garment laundering purposes. For example, the module may snap into a docking connector integrated into the garment. When the patient needs to wash the garment or recharge the battery, they can detach the module easily. The garment portion containing sensors can be made washable by waterproofing or encapsulating the sensor connections, or by making the sensor units themselves detachable if necessary.
[0048] As shown in Fig. 4, the present invention comprises a local drug delivery reservoir system designed to provide targeted, automated pharmacologic intervention for patients at risk of deep vein thrombosis (DVT), fat embolism, or related thrombotic conditions acts as DVT / Embolism prophylaxis module . This module is seamlessly integrated into the wearable garment, complementing the biochemical sensing, Doppler ultrasound, pressure monitoring, transcutaneous gas exchange, incision integrity monitoring, predictive analytics, and hospital EMR integration systems to enable a closed-loop, real-time therapeutic response. The following describes the component architecture, operational mechanisms, drug deployment workflow, and system-level integration of the drug delivery reservoirs, ensuring a comprehensive and novel approach for patent purposes.
[0049] The drug delivery reservoir units, each measuring approximately 30 mmx15 mmx3 mm, are embedded in the inner lining(16) of the garment, with primary positioning over the posterior calves and optional placement along the popliteal fossa, thighs, or flanks — regions at higher risk for DVT or fat embolism. Each reservoir consists of a microporous drug matrix, constructed from abiodegradable polymer film, such as poly(lactic-co-glycolic acid) (PLGA) or polycaprolactone (PCL), with a porosity of 10-20 pm to ensure controlled drug release. The matrix is impregnated with a therapeutic agent, offering two payload options: low-molecular-weight heparin (LMWH) encapsulated in microcapsules (diameter: 10-50 pm, encapsulation efficiency: >85%) or aspirin (acetylsalicylic acid) incorporated as a dissolvable thin film (thickness: 50-100 pm, dissolution rate: 0.1 -0.2 mg / min in physiological conditions). The reservoir is encased in a flexible, medical-grade silicone housing (Shore A hardness: 30-40) with outlet ports (diameter: 1 mm) aligned with the skin contact region to facilitate precise drug delivery. The housing is sealed with a biocompatible adhesive to prevent leakage and ensure patient safety.
[0050] Two delivery mechanisms are provided to accommodate varying clinical needs. The first option employs a transdermal microneedle array, comprising 100-200 polymeric microneedles (length: 300-700 pm; base diameter: 50 pm; material: biodegradable polylactic acid (PLA) or polyvinyl alcohol (PVA)). These microneedles are either coated with a thin layer of LMWH or aspirin (coating thickness: 5-10 pm) or hollow-filled with a drug solution (internal channel diameter: 20 pm). The microneedles are mounted on a retractable base plate, actuated by a miniature linear actuator (stroke: 1 mm, force: 0.5 N) or a shapememory alloy trigger (e.g., nitinol, activation temperature: 40°C), powered by a low-voltage supply (3.3 V, 10 mW). The second option utilizes a passive diffusion pad, consisting of a hydrogel-based delivery matrix (thickness: 3 mm, material: polyacrylamide or polyethylene glycol (PEG), water content: 70-80%). Drug release occurs through passive diffusion driven by a concentration gradient, regulated by a controlled-permeability membrane (e.g., cellulose acetate, pore size: 0.1 -0.5 pm) to achieve a consistent dose rate. Both mechanisms are integrated into the garment’s inner lining via a snap-fit docking system, ensuring secure placement and ease of replacement.
[0051] The drug delivery process is initiated when the system detects specific triggering conditions, continuously monitoring inputs from the biochemical sensor module (e.g., D-dimer levels exceeding 500 ng / mL) and the Doppler ultrasound patch (e.g., posterior tibial vein flow below 10 cm / s or a non-phasic waveform). Ifeither or both conditions are met, the system classifies the patient as requiring prophylactic action.
[0052] The control module, equipped with a 32-bit microcontroller (clock speed: 80 MHz, 256 KB RAM), evaluates a composite risk score by integrating sensor data with vital signs (e.g., heart rate, SpO2) and incision integrity metrics. Upon confirmation of significant thrombotic risk, the microcontroller sends an activation signal to the drug delivery reservoir in the at-risk region, such as the left calf, via a secure I2C communication protocol. In microneedle mode, the retractable base plate presses the microneedles against the skin for a preset duration (10-15 minutes), delivering the drug either via coated surfaces or through hollow channels connected to the micro-reservoir (capacity: 0.5-1 mL). After delivery, the needles retract into the housing to prevent prolonged contact or skin trauma, with retraction confirmed by a position sensor (accuracy: ±0.1 mm). In diffusion pad mode, the embedded hydrogel swells upon activation (swelling ratio: 10- 15%), releasing medication at a rate of approximately 0.3-0.6 mg / cm2 / hour for heparin or 2-5 mg / hour for aspirin, configurable based on patient size and reservoir location. An optional thermo-responsive trigger, utilizing a micro-heater coil (power: 50 mW, temperature: 40-42°C), enhances skin permeability by increasing local blood flow, with a response time of 10-20 seconds.
[0053] Each reservoir includes a flow sensor (resistive or capacitive, sensitivity: ±0.01 mL / min) to confirm successful drug release and an optional temperature sensor (accuracy: ±0.1 °C) to ensure safe dermal delivery within a temperature range of 37-43°C. The system logs dose delivery details, including timestamp, duration, and sensor verification, in the garment’s onboard memory (16 MB flash) and synchronizes this data with the mobile application via Bluetooth Low Energy (BLE, data rate: 1 Mbps). Patients are notified via the mobile app with messages such as “Heparin delivered to left calf at 10:04 AM - no action needed,” displayed on a user interface with a timestamp and dose confirmation. The reservoirs are designed as disposable cartridges, with microneedle modules or diffusion pads sliding into docking recesses in the garment lining for replacement during followup visits. Drug stability is maintained for over 30 days at room temperature (20- 25°C), ensured by the sealed silicone housing and a moisture-resistant barrier. A built-in lockout feature, implemented via firmware, prevents over-delivery bylimiting activation to once every 6-8 hours per site, with a programmable override for clinical customization.
[0054] The local drug delivery system(62) operates within a closed-loop coordination framework as shown in Fig. 7 , initiating release only when sensor data and patient state confirm significant thrombotic risk. It integrates with the garment’s alert system, triggering vibration (via piezoelectric actuators, 100-200 Hz) and mobile app prompts, and provides a DVT risk dashboard(64) for clinicians, displaying dose history, triggering causes, and correlated sensor data (e.g., D- dimer trends, venous flow rates). Drug release events are automatically updated in the patient’s electronic medical record (EMR) via HL7 / FHIR protocols over BLE or LTE connectivity, ensuring seamless clinical integration. Fail-safe measures enhance reliability: if a reservoir fails to respond or deliver the dose (detected via flow sensor feedback), a redundancy warning is sent to the mobile app, an optional instruction for manual oral prophylaxis is displayed, and a visual indicator(66) on the garment (e.g., an LED displaying “Delivery Failed - Replace Module”) alerts the patient. The system’s integration with the predictive analytics hub(68) further refines drug delivery decisions by incorporating multidimensional risk indices, while the augmented reality (AR) module may guide patients to adjust garment positioning post-delivery to optimize therapeutic outcomes.This local drug delivery reservoir system (62) enhances the wearable garment’s capability to provide targeted, automated prophylaxis, working synergistically with other monitoring modules to deliver timely interventions, improve patient safety, and facilitate seamless clinical connectivity, thereby offering a novel and critical component for comprehensive post-operative care.
[0055] 3. Doppler-Echo Micro-Ultrasound Patch
[0056] The present invention further includes a doppler-echo micro-ultrasound patch(50), an advanced component designed for non-invasive monitoring of blood flow dynamics, particularly in the posterior tibial vein, to detect early signs of venous thrombosis or other circulatory abnormalities. This module is seamlessly integrated into the wearable garment or patch system, complementing the biochemical sensing capabilities to provide comprehensive, real-time cardiovascular risk assessment. The following describes the component architecture, functional operation, signal processing, and system-level integrationof the micro-ultrasound module. As shown in a schematic way in Fig.6, The doppler-echo micro-ultrasound patch is a flexible, conforming structure with approximate dimensions of 50 mm x 30 mm x 2 mm, designed for placement on the posterior-medial calf region, directly overlying the posterior tibial vein. The patch is affixed to the inner surface of the compression garment using a biocompatible adhesive to ensure secure and comfortable wear. The core of the patch consists of a linear array(54) of capacitive micromachined ultrasonic transducers (CMUTs)(53) or piezoelectric microelements, operating at a frequency centered between 2.0-2.5 MHz to enable deep venous imaging. The transducer array(52) comprises 32-64 microelements, each approximately 0.5 mm x 0.5 mm x 0.1 mm, with a spacing of 0.5 mm to facilitate Doppler angle steering. An impedance-matched silicone gel interface(56) serves as a matching layer to couple sound waves into soft tissue, while a damped polymer backing isolates echoes and absorbs excess energy. The patch connects to the central control module(58) via a fine, shielded flex-circuit, ensuring reliable signal transmission. The patch operates by emitting pulsed wave Doppler ultrasound bursts, consisting of 1-2 cycles per emission, at a fixed pulse repetition frequency (PRF) of approximately 2 kHz. A beamforming microcontroller, located either onboard the patch or within the main control unit, directs phase-delayed excitation to achieve linear scan coverage along the posterior tibial vein. Returning echoes from flowing blood cells are captured by the receiving elements, and the Doppler frequency shift is extracted using quadrature demodulation and fast Fourier transform (FFT) over a 1-3 second sample window. This process achieves a velocity resolution of ±1 cm / s, with a detection range of up to 50 cm / s, enabling precise measurement of blood flow dynamics. The acquired data is processed to analyze flow patterns. A pulsatile waveform synchronized with respiration, indicative of phasic flow, suggests normal venous function. Conversely, a flat-line or continuous waveform, indicative of nonphasic or absent flow, suggests potential venous thrombosis or external compression. Quantitative criteria are applied to enhance diagnostic accuracy: a mean velocity below 10 cm / s sustained for over 3 minutes triggers a “slow flow” flag, while loss of phasicity or detection of retrograde flow triggers a “possible obstruction” flag. These flags are integrated into the system’s decisionmaking framework.The micro-ultrasound module’s data is cross-validated withother physiological parameters, including leg immobility, tachycardia, downwardtrending SpO2, and elevated D-dimer levels detected by the biochemical sensing module. When Doppler abnormalities co-occur with these parameters, the system escalates to a Tier II alert, initiating multiple response mechanisms. These include an on-garment alert comprising vibration and a tone, a mobile application notification stating, “Possible DVT detected - elevate leg and contact provider,” and optional telemetry to a clinical dashboard if electronic medical record (EMR) integration is active. This multimodal approach ensures timely detection and escalation of potential deep vein thrombosis (DVT) or other circulatory issues. The doppler-echo micro-ultrasound patch (50) enhances the wearable system’s capability to monitor cardiovascular health by providing precise, non-invasive blood flow analysis. Its integration with the biochemical sensing module and other vital sign monitors enables a comprehensive, automated approach to early detection and intervention, improving patient outcomes through real-time alerts and seamless clinical connectivity.
[0057] As shown in Fig. 3, the present invention further comprises, a sophisticated local drug delivery reservoir system(10) designed to provide targeted, automated pharmacologic intervention for patients at risk of deep vein thrombosis (DVT), fat embolism, or related thrombotic conditions. This module is seamlessly integrated into the wearable garment, complementing the biochemical sensing and Doppler ultrasound capabilities to enable a closed-loop, real-time therapeutic response. The following describes the component architecture, operational mechanisms, drug deployment workflow, and system-level integration of the drug delivery reservoirs. The drug delivery reservoir units, each measuring approximately 30 mm x 15 mm x 3 mm, are embedded in the inner lining of the garment, with primary positioning over the posterior calves and optional placement along the popliteal fossa, thighs, or flanks — regions at higher risk for DVT or fat embolism. Each reservoir(12) consists of a microporous drug matrix, constructed from a biodegradable polymer film(15) (e.g., poly(lactic-co-glycolic acid) (PLGA) or polycaprolactone (PCL)), impregnated with a therapeutic agent such as low- molecular-weight heparin (LMWH) encapsulated in microcapsules (10-50 pm in diameter) or aspirin (acetylsalicylic acid) incorporated as a dissolvable thin film (50-100 pm thick). The reservoir is encased in a flexible, medical-grade siliconehousing with outlet ports aligned with the skin contact region to facilitate drug delivery. Two delivery mechanisms are provided. The first option employs a transdermal microneedle array(14), comprising 100-200 polymeric microneedles (length: 300-700 pm; base diameter: 50 pm), either coated with or hollow-filled with LMWH or aspirin solution. These microneedles are mounted on a retractable base plate activated by a miniature linear actuator or shape-memory alloy trigger. The second option utilizes a passive diffusion pad, consisting of a hydrogelbased delivery pad (approximately 3 mm thick) placed against the skin. Drug release occurs through passive diffusion driven by a concentration gradient, regulated by a controlled-permeability membrane to ensure precise dosing. The drug delivery process is initiated when the system detects specific triggering conditions, continuously monitoring inputs from the biochemical sensor module (e.g., D-dimer levels exceeding 500 ng / mL) and the Doppler ultrasound patch (e.g., posterior tibial vein flow below 10 cm / s or a non-phasic waveform). If either or both conditions are met, the system classifies the patient as requiring prophylactic action. The control module evaluates a composite risk score and sends an activation signal to the drug delivery reservoir in the at-risk region, such as the left calf. In microneedle mode, the retractable microneedle plate presses against the skin for a preset duration (10-15 minutes), delivering the drug either via coated needle surfaces or through hollow channels connected to the microreservoir. After delivery, the needles retract into the housing to prevent prolonged contact or skin trauma. In diffusion pad mode, the embedded hydrogel swells slightly upon activation, releasing medication through the skin at a rate of approximately 0.3-0.6 mg / cm2 / hour for heparin or 2-5 mg / hour for aspirin, configurable based on patient size and reservoir location. An optional thermo- responsive trigger, such as a micro-heater coil, may be employed to enhance skin permeability. Each reservoir includes a flow sensor (resistive or capacitive) to confirm successful drug release and an optional temperature sensor to ensure safe dermal delivery. The system logs the dose delivery timestamp, duration, and sensor verification, notifying the patient via the mobile application (e.g., “Heparin delivered to left calf at 10:04 AM - no action needed”). The reservoirs are designed as disposable cartridges, single-use units that slide into docking recesses in the garment lining for easy replacement during follow-up visits. Drug stability is maintained for over 30 days at room temperature, and a built-in lockoutfeature prevents over-delivery by limiting activation to once every 6-8 hours per site. The drug delivery system operates in a closed-loop coordination framework, initiating drug release only when sensor data and patient state jointly confirm significant thrombotic risk. It integrates with the garment’s alert system, triggering vibration and mobile app notifications, and provides a DVT risk dashboard for clinicians, displaying dose history, triggering causes, and correlated sensor data. Drug release events are automatically updated in the patient’s electronic medical record (EMR) via HL7 / FHIR integration. Fail-safe measures ensure reliability: if a reservoir fails to respond or deliver the dose, a redundancy warning is sent to the mobile app, an optional instruction for manual oral prophylaxis is displayed, and a visual indicator on the garment signals “Delivery Failed - Replace Module. ’’This local drug delivery reservoir system enhances the wearable garment’s ability to provide targeted, automated prophylaxis, working in concert with the biochemical sensing and Doppler ultrasound modules to deliver timely interventions, improve patient safety, and facilitate seamless clinical integration
[0058] The present invention incorporates by a sophisticated pressure monitoring and compliance feedback system integrated into the wearable garment, designed to ensure consistent therapeutic compression and enhance patient adherence to prescribed treatment protocols. The following describes the component architecture, operational functionality, and system-level integration of the pressure monitoring system, with enhanced technical details to support its novelty and utility in a patent context. The pressure monitoring system (30) comprises a grid(32) of thin, flexible pressure sensors(34), utilizing either resistive or capacitive sensing technology, laminated across the entire inner surface of the garment. Each sensor(34) is constructed from a flexible, biocompatible polymer substrate, such as polyimide or polyethylene terephthalate (PET), with a thickness of approximately 50-100 pm to ensure conformability to the body’s contours. Resistive sensors incorporate a conductive polymer layer (e.g., carbon-loaded silicone) with a resistance range of 1-100 kQ, varying inversely with applied pressure, while capacitive sensors utilize a dielectric elastomer layer (e.g., polydimethylsiloxane (PDMS)) sandwiched between conductive electrodes (e.g., silver nanowire mesh), with a capacitance range of 10-100 pF. The sensor grid is arranged in a matrix configuration, with individualsensor nodes spaced approximately 10-20 mm apart, covering key therapeutic regions such as the abdomen, flanks, thighs, and calves. Each node, measuring approximately 5 mm x 5 mm, is interconnected via flexible, conductive traces(36) (e.g., printed silver ink) embedded within the garment’s inner lining, ensuring durability and minimal interference with wearer comfort. The sensors are powered by a low-voltage supply (1 .5-3.3 V) from the garment’s central control module, with a total power consumption of less than 50 mW to support prolonged operation.The pressure sensors continuously measure local pressure distribution in millimeters of mercury (mmHg), verifying that therapeutic compression levels, typically 20-30 mmHg as prescribed for DVT prophylaxis, are maintained uniformly across the garment’s contact surfaces. The sensors operate with a resolution of ±1 mmHg and a dynamic range of 10-50 mmHg, calibrated to detect deviations from the surgeon-specified therapeutic range. Data from each sensor node is sampled at a frequency of 1 Hz and transmitted to the central microcontroller via a multiplexed analog-to-digital converter (ADC) with 12-bit resolution, ensuring high-fidelity pressure mapping. The system employs a proprietary algorithm to analyze spatial and temporal pressure variations, generating a real-time pressure distribution map that identifies areas of suboptimal compression (e.g., <15 mmHg due to a loose strap or garment malposition) or excessive pressure (e.g., >40 mmHg, indicating potential discomfort or tissue ischemia risk). Upon detection of pressure deviations outside the prescribed range, the system initiates immediate corrective feedback. A haptic alert, delivered via integrated piezoelectric actuators (dimensions: 10 mm x 5 mm x 0.5 mm, operating at 100-200 Hz), provides localized vibration at the site of improper compression, prompting the patient to adjust the garment. Concurrently, a notification is sent to the associated mobile application, displaying a message such as “Compression low on left thigh - tighten strap and re-don garment” or “Excessive pressure detected on abdomen - loosen strap for optimal fit.” The mobile app includes a visual interface with a color-coded pressure map (e.g., green for 20-30 mmHg, yellow for 15-20 mmHg or 30-35 mmHg, red for <15 mmHg or >35 mmHg), guiding the patient through precise adjustments. This active feedback mechanism, which dynamically verifies and corrects compression levels in real time, represents a novel advancement over existing compression garments that claim static pressure ranges (e.g., 20-30mmHg) without mechanisms for real-time monitoring or user-guided correction.The system also logs long-term compliance statistics, including total wear time, average pressure per region, and frequency of pressure deviations, stored in the garment’s onboard memory (e.g., 16 MB flash storage) and synchronized with the mobile app via Bluetooth Low Energy (BLE). These statistics are aggregated into a compliance report, accessible to clinicians through an electronic medical record (EMR) interface using HL7 / FHIR standards, enabling surgeons to review patient adherence and adjust treatment plans accordingly. For example, the report may indicate “92% wear time compliance, average thigh pressure 22 mmHg, 3 deviations below 15 mmHg in past 7 days,” providing actionable insights into garment performance and patient behavior.The pressure monitoring system integrates seamlessly with the garment’s other modules, enhancing the overall therapeutic efficacy. Pressure data is cross- referenced with inputs from the biochemical sensing module (e.g., elevated D- dimer levels), Doppler ultrasound patch (e.g., reduced venous flow), and local drug delivery system (e.g., recent heparin administration). If suboptimal compression coincides with high-risk indicators, such as D-dimer >500 ng / mL or mean venous flow <10 cm / s, the system escalates to a Tier II alert, triggering intensified haptic feedback, mobile app notifications, and optional clinician alerts via telemetry. This multimodal integration ensures that compression therapy is optimized in the context of the patient’s broader cardiovascular risk profile. Additionally, the system includes fail-safe mechanisms: if a sensor node fails (e.g., detected via periodic self-diagnostic checks), the microcontroller redistributes pressure calculations to adjacent nodes, and a warning is sent to the mobile app, advising replacement of the affected garment section.This pressure monitoring and compliance system introduces a critical quality-control layer, ensuring that therapeutic compression is consistently applied within the prescribed range, actively guiding patients to maintain proper garment fit, and providing clinicians with verifiable compliance data. By addressing the limitations of existing compression garments, which lack real-time pressure verification and automated feedback, this system enhances patient safety, treatment efficacy, and clinical oversight, making it a novel and essential component of the integrated wearable solution for cardiovascular risk management.
[0059] The present invention further incorporates an advanced transcutaneous gas exchange monitoring system integrated into the wearable garment, designed to non-invasively measure transcutaneous partial pressures of carbon dioxide (TCPCO2) and oxygen (TcPO2) to detect early signs of respiratory compromise, hypoventilation, or localized perfusion deficits, particularly in the context of cardiovascular and post-surgical monitoring. The following describes the component architecture, operational functionality, and system-level integration of the transcutaneous gas exchange monitoring system(40). The transcutaneous gas exchange monitoring system comprises a miniature sensor, utilizing either electrochemical or optical sensing technology, strategically placed beneath the chest portion of the garment to optimize proximity to the sternal or subclavicular region, where skin thickness and vascularity facilitate accurate gas diffusion measurements. The sensor, measuring approximately 15 mm x 15 mm x 2 mm, is constructed from a biocompatible, flexible silicone substrate to ensure conformal skin contact and patient comfort. For electrochemical sensors, the system employs a dual-electrode configuration: a silver / silver chloride (Ag / AgCI) reference electrode(42) and a platinum-based working electrode (44), separated by a semi-permeable membrane(46) (e.g., polytetrafluoroethylene (PTFE), thickness 10 pm) that selectively allows CO2and O2diffusion. The electrochemical sensor operates at a low voltage (0.6-0.8 V) with a current output range of 1-50 pA, proportional to gas concentration, and achieves a detection resolution of ±1 mmHg for TcPCO2(range: 20-80 mmHg) and TcPO2(range: 50-150 mmHg). Alternatively, in other embodiment of invention, the optical sensor variant uses luminescence-based technology, incorporating a ruthenium-based fluorophore embedded in a gas-permeable polymer matrix (e.g., silicone or hydrogel). Excitation is provided by a blue LED (wavelength: -450 nm), and emitted fluorescence (wavelength: -600 nm) is modulated by O2and CO2quenching, measured by a photodiode with a sensitivity of 0.1 nW. The optical sensor offers a faster response time (5 seconds) compared to the electrochemical sensor (-10 seconds) and requires less frequent calibration.To enhance measurement accuracy, the sensor is paired with a micro-heater element (e.g., a 5 mm x 5 mm resistive coil, power consumption: 20-50 mW) to maintain a controlled skin temperature of 41-43°C, promoting vasodilation andgas diffusion through the stratum corneum. A thermistor (accuracy: ±0.1 °C) monitors skin temperature to prevent thermal injury and optimize sensor performance. The sensor is encapsulated in a breathable, hypoallergenic silicone housing with a diameter of 20 mm and a thickness of 1 mm, affixed to the garment’s inner lining via a biocompatible adhesive. Data is transmitted to the central control module through a shielded, flexible conductive trace (e.g., copper- coated polyimide, width: 0.5 mm), ensuring reliable signal integrity. Power is supplied via the garment’s low-voltage bus (3.3 V), with a total power consumption of less than 100 mW, supported by the garment’s rechargeable lithium-polymer battery.The transcutaneous sensor continuously measures TCPCO2and TcPO2, providing real-time insights into respiratory and perfusion status. A sudden rise in TcPCO2(e.g., >50 mmHg sustained for >5 minutes) indicates potential hypoventilation, while a decline in TcPO2(e.g., <60 mmHg over the abdominal region) suggests compromised perfusion or early tissue necrosis, particularly relevant for post-liposuction monitoring. The sensor data is sampled at 0.1 Hz and processed by the central microcontroller using a 16-bit analog-to-digital converter (ADC), ensuring high-resolution gas pressure measurements. A proprietary algorithm filters noise (e.g., motion artifacts) and calibrates readings against baseline skin temperature and ambient conditions, achieving a measurement accuracy of ±2 mmHg. When a sudden TcPCO2increase coincides with a drop in SpO2(<90%, as measured by the garment’s reflective photoplethysmography (PPG) module), the system triggers a Tier II alarm, signaling early respiratory compromise before systemic hypoxemia develops. Similarly, a TcPO2decline over the abdominal liposuction site, when correlated with pressure sensor data indicating suboptimal compression or Doppler ultrasound data showing reduced venous flow, flags a potential local complication such as tissue ischemia or necrosis. The transcutaneous gas exchange monitoring system integrates seamlessly with the garment’s other modules to enhance diagnostic sensitivity. For instance, elevated TcPCO2combined with biochemical sensor data (e.g., D-dimer >500 ng / mL) and Doppler ultrasound findings (e.g., venous flow <10 cm / s) escalates the patient to a high- risk category, prompting immediate actions such as haptic alerts (via piezoelectric actuators), mobile app notifications (e.g., “Respiratory compromisedetected - seek medical attention”), and optional telemetry to a clinician’s dashboard via HL7 / FHIR integration. The system also logs TcPCO2and TcPO2trends, stored in the garment’s onboard memory (16 MB flash) and synchronized with the mobile app via Bluetooth Low Energy (BLE), providing clinicians with longitudinal data to assess respiratory and perfusion status. A visual interface in the mobile app displays real-time gas pressure readings with color-coded indicators (e.g., green for TcPC0235-45 mmHg and TcPO280-100 mmHg, yellow for borderline values, red for critical thresholds), enabling patients and caregivers to monitor trends and respond promptly.To ensure reliability, the system includes fail-safe mechanisms. Periodic self-diagnostic checks verify sensor functionality (e.g., electrode impedance for electrochemical sensors or fluorescence intensity for optical sensors), and any failure triggers a warning in the mobile app, advising sensor replacement. Redundant measurements from adjacent sensors (e.g., SpO2from PPG or pressure sensors) compensate for temporary sensor malfunctions, maintaining system integrity. Unlike existing wearable systems that rely solely on reflective PPG for SpO2monitoring, this transcutaneous gas exchange module introduces a novel, non-invasive approach to detecting early respiratory and perfusion issues, offering greater sensitivity and specificity for critical conditions. By integrating TcPCO2and TcPO2monitoring with other physiological data streams, the system enhances the garment’s ability to provide timely, actionable insights, improving patient outcomes and facilitating clinical decision-making in cardiovascular and post-surgical care.
[0060] The present invention further incorporates an advanced incision integrity monitoring system integrated into the wearable garment, designed to surveil post- surgical incision and scar zones for early detection of complications such as seroma formation, hematoma, or wound dehiscence, thereby expanding the garment’s functionality beyond cardiovascular and thrombotic risk management to comprehensive post-operative wound care. The following describes the component architecture, operational functionality, and system-level integration of the incision integrity monitoring system.The incision integrity monitoring system comprises an array of flexible, adhesive sensors, utilizing resistive / stretch or impedance-based sensing technologies, strategically overlaid across each incision or scar zone on the body, such as the abdomen, flanks, thighs, or othersurgical sites relevant to liposuction or related procedures. Each sensor is fabricated from a biocompatible, elastomeric substrate, such as medical-grade silicone or polyurethane (thickness: 50-100 pm), ensuring flexibility and conformal adhesion to the skin’s dynamic contours. Resistive / stretch sensors are composed of a conductive polymer composite (e.g., carbon nanotube (CNT)- loaded polydimethylsiloxane (PDMS)), with a resistance range of 10-500 kO that varies linearly with mechanical strain (sensitivity: ±0.1% strain). Impedancebased sensors employ a pair of microelectrodes (e.g., gold or silver, dimensions: 2 mm x 2 mm) embedded in a flexible polyimide matrix, measuring tissue impedance across a frequency range of 1 kHz to 100 kHz (impedance range: 100 Q to 10 kQ). The sensor array is configured in a grid pattern, with individual sensor nodes (spacing: 5-10 mm) covering the entire incision zone, typically spanning 10-50 cm2per surgical site. These nodes are interconnected via flexible, conductive traces (e.g., printed graphene ink, width: 0.3 mm) embedded within the garment’s inner lining, ensuring durability and minimal interference with wearer comfort. The sensors operate on a low-voltage supply (1 .5-3.3 V) from the garment’s central control module, with a power consumption of less than 20 mW per sensor array, enabling continuous monitoring without compromising battery life.The sensors continuously monitor micro-stretch and skin impedance changes to detect early indicators of wound complications. Resistive / stretch sensors measure mechanical tension across the incision site, detecting excessive strain (e.g., >2% elongation) indicative of tissue swelling or wound dehiscence. Impedance-based sensors assess changes in tissue electrical properties, where a rise in impedance (e.g., >1 kO above baseline) suggests fluid accumulation characteristic of seroma or hematoma formation. Data from each sensor node is sampled at 0.5 Hz and processed by the central microcontroller using a 12-bit analog-to-digital converter (ADC), achieving a resolution of ±0.1 kO for impedance and ±0.05% for strain. A proprietary algorithm filters noise from motion artifacts or skin moisture variations, calibrating measurements against baseline skin impedance and tension established during initial garment fitting. If local impedance exceeds a predefined threshold (e.g., 30% above baseline, sustained for >5 minutes) or excessive tension is detected (e.g., strain >2% for >3 minutes), the system generates a localized prompt, delivered via haptic feedback (using piezoelectric actuators, 5 mm x 5 mm, 100-200 Hz) and amobile app notification stating, “Excessive fluid accumulation at incision — elevate area and notify surgical team.” The mobile app displays a real-time incision status map, with color-coded indicators (e.g., green for normal, yellow for borderline impedance / strain, red for critical thresholds), guiding patients and caregivers to take immediate action.
[0061] The incision integrity monitoring system integrates seamlessly with the garment’s other modules to enhance diagnostic accuracy and therapeutic response. For instance, elevated impedance suggestive of seroma formation is cross-referenced with transcutaneous TcPO2data (e.g., <60 mmHg, indicating compromised perfusion), pressure sensor data (e.g., suboptimal compression <15 mmHg), or biochemical sensor data (e.g., elevated D-dimer >500 ng / mL). When correlated with these parameters, the system may escalate to a Tier II alert, triggering intensified haptic feedback, mobile app notifications, and optional telemetry to clinicians via HL7 / FHIR integration. In coordination with the augmented reality (AR) module, the system can activate the AR app to display a visual overlay guiding the patient to apply gentle compression or adjust positioning to facilitate fluid drainage toward a surgical drain site, enhancing patient compliance. All sensor data, including impedance and strain trends, are logged in the garment’s onboard memory (16 MB flash) and synchronized with the mobile app via Bluetooth Low Energy (BLE), providing clinicians with longitudinal data for wound surveillance. The predictive analytics hub further processes incision data alongside other physiological metrics, enabling early warnings of complications up to 6-12 hours before clinical manifestation, such as predicting seroma progression based on subtle impedance increases and declining TcPO2.
[0062] To ensure reliability, the system incorporates fail-safe mechanisms. Periodic self-diagnostic checks verify sensor functionality (e.g., electrode continuity for impedance sensors or resistance stability for stretch sensors), and any failure triggers a warning in the mobile app, advising replacement of the affected sensor array. Redundant measurements from adjacent sensors (e.g., pressure or gas exchange modules) compensate for temporary malfunctions, maintaining system integrity. Unlike prior art, which focuses primarily on embolism detection or static compression in post-liposuction garments, this incision integrity monitoringsystem introduces a novel approach by integrating incision-specific surveillance into a wearable platform. By providing real-time, localized monitoring of microstretch and impedance changes, the system enhances early detection of wound complications, improves patient outcomes, and supports clinical decision-making through seamless integration with hospital systems and AR-guided interventions, making it a critical component of the comprehensive wearable solution for postoperative care.
[0063] The system also comprises dedicated mobile app running on the patient’s smartphone (or on a provided device). The app pairs with the garment’s control module via a secure wireless (Bluetooth) connection. Through the app, real-time vital sign data is received and displayed in a user-friendly interface. The app can show the current heart rate, oxygen saturation percentage, respiration rate, activity level, and possibly graphs or trends over time. It may also have indicators for the garment’s battery level and connectivity status. Beyond just displaying data, the app plays a crucial role in alert management:
[0064] It runs as a background service so that alerts from the garment are processed immediately, even if the phone screen is off.
[0065] If an abnormal condition arises, the app will generate its own notification and audible alarm on the phone, to ensure the patient is informed (this complements the garment’s built-in buzzer / vibrator alarm).
[0066] The app can be configured to automatically forward alerts to predefined emergency contacts, such as the patient’s surgeon, a family member, or a professional monitoring service. For example, if a serious embolism risk event is detected, the app could send a text message or push notification to the medical team with details (e.g., “Alert: Patient X - oxygen 85% (low), HR 130 bpm (high), possible embolism - at 2:30 PM”).
[0067] The app allows customization of threshold values and alarm sensitivity within safe limits set by healthcare providers. For instance, a doctor might adjust the alarm criteria if a particular patient’s baseline oxygen saturation is normally slightly lower than average, to reduce false positives.
[0068] Data Logging: All monitored data can be logged in the app and optionally uploaded to a secure cloud server or electronic health record. This historical datacan be reviewed in follow-up visits to assess the patient’s recovery progress (for example, checking if their mobility improved daily, or if there were any transient drops in oxygen overnight).
[0069] The app’s interface may include a simple one-button emergency call feature. If the system alerts a potential embolism and the patient is conscious, the app can prompt them with a message like, “We detected a possible issue. Do you need help?” along with a single tap button to call emergency services. In cases where the patient might be incapacitated (e.g., no motion detected after an alert), the system can automatically send an emergency alert to caregivers or EMS to check on the patient immediately.
[0070] Operation and Embolism Detection Logic: In use, once the patient is wearing the garment and the system is activated, it continuously (or periodically) monitors the vital signs. The data is processed by the control unit’s firmware to check for any threshold breaches or abnormal patterns that could indicate a problem:
[0071] Heart Rate Monitoring: The system can establish a baseline resting heart rate for the patient (for example, a normal post-operative resting heart rate might be expected in the range of 60-100 beats per minute, unless pain or stress elevates it). The firmware sets threshold heart rate limits (which can be personalized for the patient) such that if the heart rate exceeds a high threshold (e.g., >120 bpm) or falls below a low threshold (e.g., <50 bpm) for a sustained period, it is flagged. A rapid, unexplained heart rate increase could be a sign of distress or pain (or a pulmonary embolism causing tachycardia). A sudden bradycardia (very slow heart rate) might indicate collapse or a vasovagal episode.
[0072] Blood Oxygen (SpO2) Monitoring: The system continuously checks the blood oxygen saturation. In a healthy recovering patient, SpO2should typically be in the mid to high 90s (%). If it drops below a critical threshold (commonly around 90%, or a custom threshold defined by the doctor, e.g., 88% for more sensitivity), the system treats this as a red flag. An alarm condition is triggered if the low oxygen reading persists beyond a short time delay (to avoid false alarms from a momentary sensor glitch). A significant drop in oxygen is one of the key indicators of a pulmonary embolism or respiratory compromise.
[0073] The respiratory rate is tracked continuously. A normal adult resting respiratory rate might be -12-20 breaths per minute. The system can detect abnormally high breathing rates (tachypnea, which might occur if the patient is short of breath or anxious) and abnormally low or zero respiratory activity (apnea). If the patient’s breathing rate goes above a set threshold (for example >30 breaths / min) or if no breathing movement is detected for a preset duration (such as more than 15 seconds of apnea), the system marks this as an anomaly. In combination with other signs, prolonged apnea or very shallow breathing could mean the patient has lost consciousness or is in respiratory failure.
[0074] The accelerometer data is used to infer the patient’s activity and position. The system can determine if the patient is lying down, sitting, or moving around. Lack of movement for long periods can be normal during sleep, so the firmware can use context (time of day, known sleep schedule) to distinguish expected inactivity from unexpected stillness. However, if a vital-sign alarm condition occurs and simultaneously the motion sensor(4) indicates the patient is not moving (especially at a time they would normally be active), this combination strengthens the assessment that the patient may be incapacitated and in need of help. Additionally, sudden motions like a fall can be detected (if the accelerometer senses a rapid jolt followed by no movement, it could indicate the patient collapsed).
[0075] The logic in the control unit continuously evaluates the sensor inputs together. Rather than triggering on a single transient reading, the firmware can use a simple algorithm or state machine to confirm an alarm state. For example, it might require that two or more parameters are in alarming ranges simultaneously (to reduce false alarms) - e.g., if SpO2< 90% and heart rate > 120 bpm (or <50 bpm) and motion = none (patient is still) for over 30 seconds, then trigger a full alarm. In other scenarios, a very severe single-parameter change (like oxygen dropping extremely low or the heart rate stopping) would trigger an immediate alarm on its own. When an alarm condition is met:The garment’s alert mechanism is activated. The vibration motor will start buzzing strongly in a distinctive pattern (for instance, continuous vibration or repeated pulses) to get the patient’s attention. If a speaker is present, it can emit an audible tone or a spoken alert (potentially even a pre-recorded voice prompt like“Medical Alert - check your phone!”). The purpose of the local alarm is to rouse the patient if they are drowsy or sleeping, and to prompt them to take action (such as taking deep breaths, moving their legs, or calling for help) if possible. If the patient is truly incapacitated, the local alarm could alert nearby family members or caretakers in the home.
[0076] Simultaneously, the control unit sends an immediate alert signal to the mobile app. The app, upon receiving this signal, will display a warning message and play its own alarm sound (it can be configured to override a phone’s silent mode for such critical alerts). The app will indicate the nature of the alarm (e.g., “Low Oxygen Level Detected” or “No Movement Detected - Possible Emergency”) to inform the patient or anyone near the phone.
[0077] The app will then forward the alert to remote recipients as configured. This can be done through multiple channels: a push notification to another smartphone (e.g., the surgeon’s phone with a companion app), an SMS text message to a caregiver, or an email / pager alert to a monitoring center. The alert message includes critical information such as the patient’s latest vital readings, the time of the event, and possibly the patient’s GPS location if emergency services need to be dispatched. The system can even be configured to call emergency services (911 or local equivalent) automatically if certain extreme conditions occur (for example, if no motion and no breathing and low oxygen are all detected together, it could initiate an automatic emergency call after, say, 60 seconds, unless the patient manually cancels the alarm).
[0078] The garment’s control unit can also log when the patient manually cancels or responds to an alarm (for instance, there may be a simple button on the module to acknowledge and silence alerts). If the patient cancels an alarm, that information is relayed to the app and can be forwarded to caregivers as well, in order to prevent unnecessary escalation (for example, avoiding an ambulance dispatch if it was a false alarm or the patient is okay).
[0079] The present invention further comprises an integrated biochemical sensing system for the early detection of coagulation markers, designed to monitor critical biomarkers such as D-dimer, fibrinogen degradation products, or prothrombin fragments (F1 +2) in a non-invasive, wearable format. This system is seamlesslyincorporated into a wearable garment or patch, enabling real-time monitoring, data acquisition, and therapeutic integration for patients at risk of coagulopathy or related cardiovascular conditions. The following describes the component architecture, functional workflow, and system-level interactions of the biochemical sensing module.
[0080] The biochemical sensing module is a compact, flexible patch with dimensions of approximately 40 mmx 20 mmx 3 mm, designed for low-profile and comfortable wear. The patch is preferably mounted laterally on the thigh, leveraging the area’s high sweat gland density and low mechanical stress, or optionally on the volar wrist for user convenience. The housing comprises a breathable polyurethane membrane outer shell with a hypoallergenic adhesive backing to ensure skin compatibility and prolonged wear. Internally, a multi-layer microfluidic chamber constructed from polydimethylsiloxane (PDMS) contains capillary channels (width ranging from 100-300 pm) to facilitate fluid transport. An absorption zone, composed of a sweat-wicking hydrogel matrix (e.g., polyacrylamide-based), efficiently channels physiological fluids, such as sweat, into the detection area for analysis. The core of the sensing module is a singleuse paper-based immunoassay strip embedded within the patch. This strip is coated with monoclonal antibodies specific to D-dimer, fibrinogen degradation products, or prothrombin fragments (F1+2), enabling selective detection of coagulation markers. The detection chemistry relies on a colorimetric readout zone, utilizing an enzyme-substrate reaction (e.g., horseradish peroxidase with tetramethylbenzidine (HRP-TMB) or colloidal gold) to produce a visual signal proportional to the concentration of the target biomarker. A miniature RGB photodiode array(1 .5 x 1 .5 mm) or a low-power complementary metal-oxide- semiconductor (CMOS) image sensor is integrated into the patch or its control module to capture the colorimetric signal. An LED excitation source, emitting at a wavelength of approximately 520-560 nm, is positioned adjacent to the strip window to illuminate the reaction zone. Optical readouts are performed every 4 hours, triggered manually via a mobile application, or automatically based on physiological parameters such as SpO2 or heart rate (HR). Calibration and quantification are achieved through an internal control band on the immunoassay strip, which ensures measurement reliability. The color intensity of the reactionzone is mapped to predefined D-dimer concentration ranges (e.g., <250 ng / mL for normal, >500 ng / mL for high risk). The analog signal from the photodiode or CMOS sensor is converted to a digital signal via an analog-to-digital converter (ADC) and transmitted to the garment’s microcontroller for further analysis and processing. The patch employs passive sweat extraction driven by osmotic pressure or active micro-lacrimal channeling, optionally triggered by localized heat or skin moisture detection. Sweat is wicked into the microfluidic pathway within 2-3 minutes, ensuring efficient fluid transport to the detection zone. Upon contact with the sampled fluid, the immobilized antibodies on the immunoassay strip bind to target coagulation markers (e.g., D-dimer), triggering a colorimetric reaction that produces a visible color change within 5-10 minutes. The resulting signal remains stable for approximately 2 hours, allowing reliable data acquisition. The optical signal is captured by the RGB photodiode array or CMOS sensor and interpreted by the control module. If the detected D-dimer concentration meets or exceeds a pre-programmed threshold (e.g., 500 ng / mL), the system generates a digital “coagulopathy high risk” flag for further action. This flag initiates several automated responses, including adjustment of a pneumatic micro-bladder cycle (described in Enhancement #1 ) to increase compression frequency, escalation of alert levels in the associated mobile application, and optional transmission of alerts to a caregiver. Additionally, the system may activate a local drug delivery module, such as a microneedle patch for heparin administration, to provide immediate therapeutic intervention. The biochemical sensing module is designed for seamless integration with other physiological monitoring systems within the wearable garment, enabling multimodal data fusion and comprehensive patient monitoring. Sensor data from the biochemical module is cross-referenced with vital signs, including SpO2levels below 90%, heart rate exceeding 120 beats per minute, lack of motion, or altered respiratory patterns. When combined with these parameters, elevated D-dimer levels may elevate the patient to a Tier II risk level, triggering urgent clinical notifications to healthcare providers. The system interfaces with a user-friendly mobile application, which displays the most recent D-dimer test result with a qualitative flag (Green for normal, Yellow for moderate risk, Red for high risk) and a timestamp. Users can schedule the next test or initiate a manual test in response to symptoms such as leg swelling or dizziness. All patch results are logged in the patient’s digitalrecord, accessible via the mobile app or integrated with hospital systems using HL7 / FHIR standards. Clinicians receive structured data, including D-dimer trends overlaid with heart rate and SpO2measurements, facilitating informed decisionmaking and timely interventions. This integrated biochemical sensing system provides a robust, non-invasive solution for early detection of coagulation markers, enhancing patient outcomes through real-time monitoring, automated therapeutic responses, and seamless integration with clinical workflows.
[0081] The present invention further incorporates a multichannel Al-driven predictive analytics hub, designed to integrate and analyze data from multiple sensor modules within the wearable garment to provide proactive risk assessment and early intervention for cardiovascular and post-surgical complications. This system comprises a secure, embedded Neural Processing Unit (NPU) integrated into the garment’s central control module, or alternatively, a companion cloud-based server for enhanced computational capacity. The NPU continuously fuses data streams from all embedded sensors, including vital signs (e.g., heart rate, SpO2), Doppler ultrasound flow metrics, biochemical D-dimer levels, pressure mapping, transcutaneous gas exchange (TcPCO2 / TcPO2), and incision impedance measurements. These data are processed using deep learning models, such as lightweight convolutional neural networks (CNNs) or long short-term memory (LSTM) networks, trained on pre-collected postoperative datasets encompassing both uncomplicated and complicated recovery scenarios. The models compute a multidimensional risk index, enabling early warnings up to 6-12 hours before critical physiological thresholds are reached, such as predicting an impending SpO2drop based on subtle TcPCO2drift and declining venous flow. This predictive capability moves beyond conventional threshold-based alerts, offering a tailor-trained, multimodal Al system optimized for post-liposuction physiology. By improving specificity and sensitivity, the system significantly reduces false positives, a common limitation in simple threshold-based alarms, thereby enhancing the reliability of early detection for conditions like deep vein thrombosis (DVT) or respiratory compromise. Complementing the predictive analytics hub, the invention includes a seamless hospital EMR and tele-ICU interface, implemented through a secure firmware stack supporting HL7 / FHIR protocols over Bluetooth Low Energy (BLE) or LTE connectivity. Upon detectionof a Tier I event (e.g., a vital sign exceeding a predefined threshold) or a Tier II event (e.g., a predictive risk score indicating elevated complication probability), the control unit automatically generates and transmits an encrypted summary packet containing vital sign history, risk scores, and device logs directly to the hospital’s electronic medical record (EMR) system or a tele-ICU dashboard. This enables surgical teams to monitor multiple postoperative patients remotely in real time, facilitating timely clinical decision-making. Unlike generic mobile app notifications, this system provides direct interoperability with clinical informatics systems, bridging the critical gap between wearable-generated data and formal hospital records, thus ensuring seamless integration into existing healthcare workflows. Additionally, the invention incorporates an augmented reality (Allguided recovery assistance system, implemented through a companion AR application compatible with smartphones or smart glasses. When sensor combinations indicate an elevated risk of complications, such as rising D-dimer levels coupled with venous stasis and borderline SpO2suggestive of early DVT, the AR app generates a visual overlay guiding the patient through specific recovery maneuvers, such as leg elevation or gentle ankle pumps, to mitigate risk. Similarly, if the incision integrity sensor detects a potential seroma, the AR overlay highlights precise locations on the patient’s body where gentle compression or specific positioning should be applied to facilitate fluid drainage toward a surgical drain site, as prescribed by the surgical team. This real-time, interactive guidance in 3D space ensures that patients not only receive alerts but also understand exactly how to respond, enhancing compliance and therapeutic efficacy. By combining predictive analytics, clinical interoperability, and AR- guided intervention, these systems collectively advance the wearable garment’s functionality, offering a novel, integrated approach to proactive patient monitoring and recovery support that significantly improves outcomes in postoperative care.
[0082] In best embodiment of invention, the control module’s battery is sized to last at least a full day (24 hours) of continuous monitoring, so that patients can wear the garment through day and night without interruption. In practice, a patient would recharge the module each day at a convenient time (for instance, during a short shower when the garment might be removed, or while sitting quietly). The system may also employ power-saving measures: for example, if the patient’svitals are stable and they are sleeping, the sampling rate could be reduced slightly to conserve power (until any parameter starts trending towards concern). The mobile app can alert the user if the garment’s battery is running low, so they know to recharge it soon, ensuring continuous protection is maintained.
[0083] Schematic diagram of the smart post-liposuction compression garment worn by a patient illustrated in Fig.1 , showing front and back views of the garment and the integrated sensor placements. In this technical illustration, each sensor type is labeled at its location on the garment (e.g., heart rate / SpO2sensor on the chest, respiration sensor around the torso, motion sensor in the control module). The control unit is visible on the abdomen area of the suit.Industrial Applicability
[0084] The invention is industrially applicable in the manufacture and use of medical devices for postoperative care, particularly wearable compression systems capable of continuous physiological monitoring, targeted therapeutic delivery, and predictive analytics. It can be employed in hospitals, ambulatory surgical centers, home rehabilitation, and remote patient monitoring programs to prevent and manage complications such as deep vein thrombosis, respiratory compromise, and wound dehiscence. The device can be produced using established textile, microelectronics, and medical-grade polymer fabrication processes, enabling large-scale production and integration into existing healthcare workflows, i
Claims
Claims
1. A Smart Post-Liposuction Compression Garment, comprising: a. a stretchable, biocompatible fabric garment(1 ) to apply therapeutic compression to one or more body regions treated by liposuction, wherein the garment comprising reinforced seams(6) and at least one open-close mechanism(7), b. a plurality of integrated sensors woven into or attached to the fabric, the sensors comprising: i. a pulse oximetry sensor(2) to measure heart rate and blood oxygen saturation (SpO2) by contacting a well-perfused area of the person’s skin, ii. a respiratory rate sensor(3) to detect chest or abdominal movement to determine respiratory rate and breathing patterns, iii. a motion and posture sensor(4) comprising an inertial measurement unit (IMU) configured, c. a Doppler ultrasound transducer array(50) integrated into the garment to measure venous blood flow velocity, d. a pressure monitoring system(30) comprises a grid(32) of thin, flexible pressure sensors(34), laminated across the entire inner surface of the garment, e.at least a transcutaneous gas exchange sensor(40) positioned beneath the chest portion of the garment, to measure transcutaneous partial pressures of CO2(TcPCO2) and O2(TcPO2), f. a plurality of microporous reservoirs(12) embedded in the garment’s inner lining(16) along the lower extremities, loaded with a special drug , and a micro- pump(18); and g. a control module(5) detachably coupled to the garment, comprising, a microcontroller, a wireless communication chip for transmitting data to an external device, a rechargeable battery and an alert mechanism.
2. The compression garment system of claim 1 , wherein the pulse oximetry sensor comprises a reflective photoplethysmographic (PPG) sensor with red and infrared LEDs and a photodetector, encased in a flexible podsewn into the garment’s inner surface, positioned in the chest or flank area.
3. The compression garment system of claim 1 , wherein the respiratory rate sensor comprises one of: a. an elastic strain gauge embedded around the midriff or chest region to measure chest or abdominal circumference changes, b. conductive fabric electrodes to measure impedance pneumography by detecting changes in electrical impedance during lung expansion and contraction; or c. an accelerometer-based sensor configured to detect vertical chest motions during inhalation and exhalation.
4. The compression garment system of claim 1 , wherein the control module sends localized alerts to the patient or surgical team upon detection of anomalies.
5. The compression garment system of claim 1 , wherein the control module includes a neural processing unit (NPU) execute deep learning models trained on postoperative datasets.
6. The compression garment system of claim 1 , wherein the control module supports HL7 / FHIR protocols.
7. The compression garment system of claim 5, wherein the models fusing data from all sensors to compute a multi-dimensional risk index and generate predictive warnings up to 6-12 hours
Citation Information
Patent Citations
Medical monitoring system and wearable physiological sensor garment
WO2025166417A1