An intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device

Abstract

This invention relates to an intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device, belonging to the field of medical device technology. It comprises a contact layer, a conductive layer, and a honeycomb support layer. The contact layer drains exudate, the conductive layer integrates a fiber optic network and an adaptive deformation mechanism, and the honeycomb support layer connects an intelligent negative pressure chamber and a gradient sterilization system. The negative pressure chamber dynamically adjusts pressure through corrugated airbags and diamond-shaped telescopic units, while the photothermal component irradiates the wound at different times and maintains a constant temperature. The sterilization system uses ultraviolet pulses and multi-stage filters to purify exudate. The intelligent control module optimizes treatment parameters in real time through a multimodal sensor network, achieving a closed-loop synergy of negative pressure, phototherapy, and sterilization. This device overcomes the limitations of traditional treatments through its integrated design, significantly improving wound repair quality and anti-infection capabilities. Simultaneously, its modular expansion and non-invasive monitoring functions reduce the burden on medical staff, providing an efficient and safe intelligent solution for burn management.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device. Background Technology

[0002] Standardized management of burn wounds is a core factor affecting patient prognosis. Negative pressure wound therapy (NPWT) maintains a moist environment by physically removing wound exudate, while photobiological therapy regulates cell metabolism and angiogenesis using specific spectral energy. The spatiotemporal synergy of these two techniques can significantly shorten the healing cycle and improve scar quality. Current clinical standard protocols require phased implementation of NPWT and phototherapy: continuous negative pressure therapy for 72-120 hours is prioritized during the exudation phase, and phototherapy is then introduced to promote tissue repair once the wound exudate volume decreases to a threshold. This sequential approach results in phototherapy intervention lagging behind the critical regulatory window of the inflammatory response, leading to disordered expression of healing-promoting factors and abnormal collagen fiber deposition, thus increasing the incidence of hypertrophic scars in patients with deep second-degree burns.

[0003] Current negative pressure wound therapy (NPWT) devices generally employ a constant pressure control mode, and fixed pressure parameters cannot adapt to the dynamic needs of wound healing. During the granulation tissue proliferation stage, continuous high negative pressure leads to mechanical damage to the microvascular network; clinical studies have confirmed that the rupture rate of newly formed capillaries is as high as 19%-23%. Phototherapy systems are difficult to integrate effectively with negative pressure devices due to structural limitations. Traditional light-guiding media experience buckling losses under negative pressure deformation, resulting in a more than 45% reduction in the energy transmission efficiency of 630nm red light, severely weakening the photobiological regulatory effect. Exudate management suffers from systemic defects; single-stage filtration devices cannot effectively intercept biofilm debris, and static ultraviolet sterilization modules have an inactivation rate of less than 65% for pathogenic bacteria in high-flow-rate exudates (>5mL / min), with the risk of selective survival of drug-resistant bacteria.

[0004] The core technological contradiction stems from the functional fragmentation and parameter disconnect of the treatment modules: the three subsystems of negative pressure regulation, photothermal intervention, and infection control lack a multi-dimensional collaborative mechanism based on the wound microenvironment. Existing equipment cannot adjust treatment parameters in real time based on real-time sensing of tissue repair status (such as pH gradient changes, granulation tissue maturity, and oxygen partial pressure fluctuations), thus failing to achieve personalized and precise treatment by relying solely on empirically-based intermittent treatment. Especially during the transition from the exudative to the granulation phase, traditional technologies cannot dynamically lower negative pressure to protect the neovascular network, nor can they synchronously and continuously adjust the intensity of red light irradiation to promote orderly collagen deposition, resulting in limitations on both healing quality and efficiency. Furthermore, derivative problems such as poor adaptability to irregular wound shapes, frequent filter clogging, and high risk of thermal damage further restrict clinical translation and application. Summary of the Invention

[0005] In view of this, the purpose of this invention is to propose an intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device. By setting up an adaptive bio-interface composed of a multi-layer composite dressing matrix and a shape memory alloy skeleton, a collaborative treatment unit integrating a multi-spectral photothermal coupling treatment module and a gradient sterilization exudate management system, and an intelligent control system based on a differential pressure sensor array and a multimodal data fusion algorithm, this invention solves the technical problems of traditional negative pressure devices being unable to dynamically adjust pressure, leading to damage to new tissue; phototherapy equipment and drainage systems being unable to adapt to wound changes in real time for collaborative treatment, resulting in low treatment efficiency, exudate retention leading to drug-resistant bacterial infection, and poor adaptability to irregular wounds. This invention achieves precise, adaptive, and closed-loop management of burn wounds.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A smart dynamic negative pressure and phototherapy integrated burn wound treatment device includes a multi-layer composite dressing substrate, which is composed of a contact layer, a conductive layer and a support layer stacked in sequence. The contact layer is fixed to the lower surface of the support layer by a snap-fit ​​structure. The conductive layer includes a mesh structure formed by interlacing optical fibers and shape memory alloy wires. The support layer is a honeycomb polymer film.

[0008] An intelligent negative pressure chamber is fixedly provided on the upper surface of the support layer. A photothermal coupling therapy component is integrated between the conductive layer and the support layer. The photothermal coupling therapy component includes a dual-wavelength LED module and a flexible heating film.

[0009] It also includes a real-time sterilization exudate management system, which is composed of a gradient filtration unit and a pulsed ultraviolet module coaxially connected. A miniature flow sensor is integrated between the outlet of the intelligent negative pressure chamber and the gradient filtration unit.

[0010] It also includes an intelligent control system, which comprises a differential pressure sensor array, a temperature sensor, a pH sensor, a near-infrared spectrometer, and a control module fixedly installed at the bottom of the multilayer composite dressing substrate. The control module is connected to the differential pressure sensor array, the temperature sensor, the pH sensor, the near-infrared spectrometer, and the micro flow sensor, respectively. The intelligent negative pressure chamber comprises a corrugated silicone airbag, a deformable frame, and a dynamic adjustment module. The corrugated silicone airbag is fixedly installed on the upper surface of the support layer. The deformable frame is fixedly installed inside the corrugated silicone airbag and is sealed to the upper surface of the support layer through the corrugated silicone airbag. The deformable frame is composed of diamond-shaped telescopic units, which are made of hinged shape memory alloy sheets. The dynamic adjustment module includes a micro linear motor for driving the deformation of the corrugated silicone airbag.

[0011] The light from the dual-wavelength LED module is focused onto the wound surface by a parabolic micro-reflector at the end of the optical fiber, and the flexible heating film is attached to the lower surface of the support layer and fixed with thermally conductive adhesive.

[0012] The gradient filtering unit is connected to the bottom of the corrugated silicone airbag via a flexible conduit, and the pulsed ultraviolet module includes a UVC lamp tube spirally wound around the outer wall of the conduit.

[0013] The differential pressure sensor array and temperature sensor are embedded and distributed at the edge of the dressing substrate. The differential pressure sensor array and temperature sensor are electrically connected to the control module through shielded signal lines. The control module is embedded in a waterproof shell on the side wall of the intelligent negative pressure chamber. The light guide fiber and shape memory alloy wire are interwoven with a 30° helix angle. The surface of the light guide fiber is coated with a silver nanoparticle antibacterial coating. The end of the light guide fiber is fixed to the parabolic micro-reflector through a slot. The focal point of the parabolic micro-reflector coincides with the light-emitting surface of the dual-wavelength LED module.

[0014] The gradient filtration unit is composed of three titanium alloy filters connected in series through the flexible conduit, with a UV irradiation gap maintained between adjacent filters. The UVC lamp tube and the quartz protective tube are coaxially nested, and the outer wall of the quartz protective tube is provided with heat dissipation fins.

[0015] The multilayer composite dressing substrate is provided with magnetic quick-connect slots at its edge. The slots of adjacent dressing units are connected by magnetic attraction to form a continuous air path, optical path and circuit channel.

[0016] Furthermore, the diamond-shaped telescopic unit is driven by the micro linear motor, the output shaft of the micro linear motor is rigidly connected to the inner wall of the corrugated silicone airbag, and the corrugated silicone airbag is provided with a pressure balance channel.

[0017] Furthermore, the dual-wavelength LED module includes blue light and red light emitting units, which are alternately stacked with the flexible heating film via a flexible circuit board. The edge of the flexible heating film is bonded and fixed to the support layer with medical adhesive.

[0018] Furthermore, the differential pressure sensor array is arranged in a ring around the outer periphery of the dressing substrate, with a spacing of 10-15 mm between adjacent sensors. The surface of the differential pressure sensor is covered with a medical-grade hydrophobic membrane and sealed and fixed with epoxy resin.

[0019] Furthermore, the control module integrates a multimodal data processing algorithm, receives signals from the differential pressure sensor array, temperature sensor, and pH sensor in real time, and dynamically adjusts the stroke of the micro linear motor, the power of the dual-wavelength LED module, and the pulse frequency of the UVC lamp tube through a PID controller.

[0020] Furthermore, the support layer and the conductive layer are connected by ultrasonic welding.

[0021] The beneficial effects of this invention are as follows:

[0022] This invention integrates dynamic negative pressure regulation and multispectral phototherapy into a composite treatment structure, facilitating targeted photobiological regulation therapy while continuously draining exudate, eliminating the treatment window caused by traditional step-by-step procedures. By constructing a gradient sterilization and adaptive pressure balance mechanism, it effectively reduces the risk of wound infection and protects fragile new tissue. Combined with an intelligent feedback system, it achieves dynamic matching of treatment parameters, effectively enabling 24 / 7 automated monitoring and adaptive dynamic combination therapy based on real-time data, avoiding energy waste and secondary tissue damage caused by single therapies. The device, through a modular dressing expansion design, flexibly adapts to burn wounds of different sizes and shapes. It also integrates non-contact monitoring and self-cleaning functions, significantly reducing the operational burden on medical staff while ensuring treatment effectiveness. This achieves intelligent, integrated, and precise burn wound management, and overcomes the limitations of traditional dressings that can only quantitatively release treatment or provide basic auxiliary monitoring. It realizes a 24 / 7 continuous real-time monitoring solution combined with synchronous adaptive adjustments to treatment, greatly improving treatment efficacy and efficiency.

[0023] Other advantages, objectives, and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination, or may be learned from practice of the invention. The objectives and other advantages of the invention can be realized and obtained through the following description. Attached Figure Description

[0024] To make the objectives, technical solutions, and advantages of the present invention clearer, the preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, wherein:

[0025] Figure 1 This is an exploded view of the entire device;

[0026] Figure 2 This is an exploded front view of the entire device;

[0027] Figure 3 This is an exploded bottom view of the entire device;

[0028] Figure 4 A front view of the structure of a real-time sterilization exudate management system;

[0029] Figure 5 This is a structural diagram of a real-time sterilization exudate management system.

[0030] Figure 6 This is a cross-sectional view of the real-time sterilization exudate management system.

[0031] Figure 7 A perspective view of the internal structure of a corrugated silicone airbag;

[0032] Figure 8 This is a diagram of the internal structure of the control module.

[0033] Figure label:

[0034] 1. Multilayer composite dressing substrate; 101. Contact layer; 102. Conductive layer; 103. Support layer; 104. Optical fiber; 105. Shape memory alloy wire; 106. Silver nanoparticle antibacterial coating; 107. Parabolic micro-reflector; 108. Honeycomb TPU film; 2. Intelligent negative pressure chamber; 201. Corrugated silicone airbag; 202. Deformable frame; 203. Rhomboid telescopic unit; 204. Micro linear motor; 206. One-way valve; 207. Hinge shaft; 3. Photothermal coupling therapy component; 301. Dual-wavelength LED module; 302. Blue light emitting unit; 303. Red light emitting unit; 304. Flexible heating film; 3 05. Thermal conductive adhesive; 306. Peltier heat dissipation module; 4. Real-time sterilization exudate management system; 401. Gradient filtration unit; 402. Primary filter; 403. Secondary filter; 404. Tertiary filter; 405. UVC lamp; 406. Quartz protective tube; 407. Heat dissipation fins; 408. Piezoelectric vibrating plate; 409. Backwash nozzle; 5. Intelligent control system; 501. Differential pressure sensor array; 502. Waterproof housing; 503. Control module; 504. Multimodal data processing unit; 505. PID controller; 506. Magnetic quick-connect slot; 507. Temperature sensor; 508. pH sensor. Detailed Implementation

[0035] like Figure 1-8As shown, one embodiment of the present invention provides an intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device, comprising a multi-layer composite dressing substrate 1, which is composed of a contact layer 101, a conductive layer 102, and a support layer 103 stacked sequentially. The contact layer 101 is made of medical-grade silicone and is fixed to the lower surface of the support layer 103 by a snap-fit ​​structure. The snap-fit ​​structure consists of a protrusion on the edge of the contact layer 101 and a groove at a corresponding position on the lower surface of the support layer 103, with the protrusion and groove being interference-fitted for fixation. The conductive layer 102 includes light-guiding fibers 104 and shape memory alloy wires 105, which are interwoven at a 30° helix angle to form a mesh structure. The surface of the light-guiding fibers 104 is coated with a silver nanoparticle antibacterial coating 106, and the end of the light-guiding fibers 104 is fixed to a parabolic micro-reflector 107 through a slot. The focal point of the parabolic micro-reflector 107 coincides with the light-emitting surface of the dual-wavelength LED module 301. The support layer 103 is a honeycomb TPU film 108 with a pore size of 0.5-1mm. The support layer 103 and the conductive layer 102 are connected by ultrasonic welding, and the welding points are distributed at the nodes of the mesh structure with a welding strength of 5-8N / cm².

[0036] A smart negative pressure chamber 2 is fixedly mounted on the upper surface of the support layer 103 using medical-grade adhesive. The smart negative pressure chamber 2 includes a corrugated silicone airbag 201, a deformable frame 202, and a dynamic adjustment module. The edge of the corrugated silicone airbag 201 is sealed to the upper surface of the support layer 103 with continuous hot melt adhesive to ensure the airtightness of the chamber. The deformable frame 202 is fixedly mounted inside the corrugated silicone airbag 201 and consists of multiple rhomboid telescopic units 203. Each rhomboid telescopic unit 203 is composed of hinged shape memory alloy sheets, and the hinge points of the rhomboid telescopic units 203 are connected by hinge shafts 207 to ensure flexible rotation. The dynamic adjustment module includes a micro linear motor 204. The rhomboid telescopic units 203 are driven by the micro linear motor 204, and the output shaft of the micro linear motor 204 is rigidly connected to the inner wall of the corrugated silicone airbag 201 via a threaded connection with a thread precision of M3-M5. The corrugated silicone airbag 201 is equipped with a pressure balance channel, and a one-way valve 206 is installed in the pressure balance channel. The opening pressure of the one-way valve 206 is 0.5-1 kPa, which is used to maintain the pressure stability in the chamber.

[0037] A photothermal coupling therapy component 3 is integrated between the conductive layer 102 and the support layer 103. The photothermal coupling therapy component 3 includes a dual-wavelength LED module 301 and a flexible heating film 304. The dual-wavelength LED module 301 includes a blue light emitting unit 302 and a red light emitting unit 303. The blue light emitting unit 302 emits blue light with a wavelength of 450-470nm, and the red light emitting unit 303 emits red light with a wavelength of 620-640nm. The blue light emitting unit 302 and the red light emitting unit 303 are arranged alternately on a flexible circuit board and a flexible heating film 304, and the layers are bonded and fixed together with medical double-sided adhesive. A flexible heating film 304 is adhered to the lower surface of the support layer 103 and fixed with thermally conductive adhesive 305. The edges of the flexible heating film 304 are bonded to the support layer 103 with medical adhesive. The power density of the flexible heating film 304 is 0.5-1W / cm², and it is connected to a Peltier heat dissipation module 306. The Peltier heat dissipation module 306 is attached to the side of the flexible heating film 304 closest to the wound surface to control the heating temperature. The parabolic micro-reflector 107 at the end of the optical fiber 104 is fixed by a slot, and its focal point coincides with the light-emitting surface of the dual-wavelength LED module 301, ensuring efficient coupling of light into the optical fiber 104.

[0038] The device also includes a real-time sterilization exudate management system 4, which consists of a gradient filtration unit 401 coaxially connected to a pulsed ultraviolet module. The gradient filtration unit 401 is connected to the bottom of a corrugated silicone airbag 201 via a flexible conduit, and the connection is sealed with a medical-grade sealing ring. The gradient filtration unit 401 consists of three stages of titanium alloy filters connected in series via a flexible conduit. The pore size of the first-stage filter 402 is 100-150μm, the pore size of the second-stage filter 403 is 50-80μm, and the pore size of the third-stage filter 404 is 20-30μm. A UV irradiation gap of 10-15mm is maintained between adjacent filters. A miniature flow sensor is integrated near the inlet of the gradient filtration unit 401 (between the outlet of the intelligent negative pressure chamber 2 and the primary filter 402) in the flexible conduit to detect the liquid flow rate and volume in real time. The miniature flow sensor is connected to the control module 503 via a wireless signal. The UVC lamp 405 of the pulsed ultraviolet module is coaxially nested with the quartz protective tube 406. The UVC lamp 405 has a wavelength of 254nm and a power of 10-20W. The outer wall of the quartz protective tube 406 is provided with heat dissipation fins 407, which have a thickness of 0.5-1mm and a spacing of 2-3mm. In addition, a piezoelectric vibrator 408 is provided at the bottom of the gradient filtration unit 401. The vibration frequency of the piezoelectric vibrator 408 is 50-60Hz to prevent filter clogging. A backwash nozzle 409 is also provided to periodically rinse the filter. In this embodiment, a negative pressure drainage bag (matching medical consumables, capacity 500mL) is connected to the end of the quartz protective tube 406 via a flexible conduit. When in use, the negative pressure drainage bag can be held in place by a Velcro strap and attached to nearby clothing, making it convenient for the patient to wear and use.

[0039] The device also includes an intelligent control system 5, which comprises a differential pressure sensor array 501, a temperature sensor 507, and a control module 503 embedded around the edge of the multilayer composite dressing substrate 1. The differential pressure sensor array 501 is arranged in a ring around the outer periphery of the multilayer composite dressing substrate 1, with an adjacent sensor spacing of 10-15 mm. The surface of the differential pressure sensor is covered with a medical-grade hydrophobic membrane and sealed with epoxy resin, with a sealing thickness of 0.3-0.5 mm. The temperature sensor 507 is a thermocouple sensor with a measurement range of 25-45℃ and an accuracy of ±0.1℃. The differential pressure sensor array 501 and the temperature sensor 507 are electrically connected to the control module 503 via shielded signal lines. The outer layer of the shielded signal lines is a polytetrafluoroethylene insulating layer with a thickness of 0.2-0.3 mm. The control module 503 is embedded within a waterproof housing 502 on the side wall of the multilayer composite dressing substrate 1. The waterproof housing 502 is made of medical-grade ABS material with an IP67 protection rating. The control module 503 integrates a multimodal data processing unit 504, which can receive signals from the differential pressure sensor array 501, temperature sensor 507, and pH sensor 508 in real time. The pH sensor 508 has a measurement range of 5.5-8.5 and an accuracy of ±0.05. The control module 503 dynamically adjusts the stroke of the micro linear motor 204, the power of the dual-wavelength LED module 301, and the pulse frequency of the UVC lamp 405 through a PID controller 505. The proportional gain of the PID controller 505 is 0.5-2, the integral time is 1-5s, and the derivative time is 0.1-1s.

[0040] In this embodiment, a near-infrared spectrometer is integrated on the same side as the control module 503 of the intelligent control system 5, specifically embedded inside the waterproof housing 502 of the side wall of the intelligent negative pressure chamber 2 (connected to the control module 503 via internal wiring). Its detection end extends through a 0.5mm diameter optical fiber channel reserved in the support layer 103 to the gap between the conduction layer 102 and the support layer 103. The detection spot is vertically projected onto the upper surface of the contact layer 101 (≤2mm from the wound contact point), ensuring that the spectral signal can penetrate the dressing substrate to obtain deep tissue information. The near-infrared spectrometer in this embodiment is a miniaturized module design, measuring 10mm × 8mm × 3mm (length × width × height), employing a distributed Bragg reflector structure, with a detection wavelength range of 700-900nm, meeting the safety band requirements for medical near-infrared tissue imaging.

[0041] The multilayer composite dressing substrate 1 has a magnetic quick-connect slot 506 on its edge. The slots of adjacent dressing units are connected by magnetic attraction to form a continuous air path, optical path and circuit channel. The magnetic attraction force is 5-10N to ensure a stable connection.

[0042] In this embodiment, firstly, based on the area and shape of the burn wound, a corresponding number of multi-layer composite dressing substrates 1 are selected and assembled using the magnetic quick-connect slots 506 on the edges of the multi-layer composite dressing substrates 1. The magnetic quick-connect slots 506 of adjacent dressing units are aligned, and docking is completed using a magnetic force of 5-10N, forming continuous air, light, and electrical pathways. With the contact layer 101 facing the wound, pressure is applied to ensure the edge of the contact layer 101 adheres tightly to the surrounding skin, ensuring no gaps (inspection standard: no air bubbles detected by transillumination).

[0043] After the device is started, the control module 503 enters the working state and first executes a self-test program: checking the response time of the differential pressure sensor array 501, temperature sensor 507, and pH sensor 508 (should be <50ms), and initializing the parameters to pressure -50mmHg, temperature 37℃, and light power 0. Subsequently, the differential pressure sensor array 501 collects pressure data at different locations on the wound at a frequency of 10Hz, with adjacent sensors spaced 10-15mm apart; the temperature sensor 507 monitors the wound temperature at a frequency of 1Hz (measurement range 25-45℃, accuracy ±0.1℃); the pH sensor 508 records the wound pH value at a frequency of 0.1Hz (measurement range 5.5-8.5, accuracy ±0.05); and the near-infrared spectrometer analyzes hemoglobin concentration (Hb) and oxygen saturation (SpO2) at a frequency of 0.05Hz. The data is transmitted to the multimodal data processing unit 504 via a shielded signal line, and then processed by moving average filtering (pressure data window N=5, i.e., taking the average value of 5 consecutive sampling points: Y). n =(X n +X n-1 +X n-2 +X n-3 +X n-4 ) / 5; Temperature data window N=3, i.e., Y n =(X n +X n-1 +X n-2 (3). When |original value - filtered value| > 3σ (σ is the standard deviation of normal data for this parameter in the past 10 minutes) is detected, it is determined to be an outlier and replaced using linear interpolation: if the nth data is an outlier, then the (n-1)th and (n+1)th normal data are taken, and the result is calculated using the formula Y_outlier = X_outlier. n-1 +(X n+1 -X n-1 The replacement value is calculated as (n-(n-1)) / ((n+1)-(n-1)). For example, if the 10th data is abnormal, the 9th value is -100mmHg, and the 11th value is -105mmHg, then the 10th abnormal value is replaced with -102.5mmHg.

[0044] The multimodal data processing unit 504 determines the healing stage based on the wound pH value and exudate volume: exudative stage (pH 5.5-6.5, exudate volume >10mL / 24h / cm²), inflammatory stage (pH 6.5-7.0, exudate volume 5-10mL / 24h / cm²), proliferative stage (pH 7.0-7.5, exudate volume <5mL / 24h / cm²), and remodeling stage (pH 7.3-7.4, exudate volume <2mL / 24h / cm²). When the pressure value deviates from the target range for the corresponding stage, the stroke of the micro linear motor 204 is adjusted by the PID controller 505 (in the PID controller parameters, Kp is the proportional coefficient, Ti is the integral time, and Td is the derivative time; Kp=1.5, Ti=3s, Td=0.5s for the exudation stage; Kp=1.2, Ti=4s, Td=0.3s for the inflammation stage; Kp=0.8, Ti=5s, Td=0.2s for the proliferation stage; Kp=0.5, Ti=6s, Td=0.1s for the remodeling stage). If the pressure is more than 10 mmHg higher than the target value, the micro linear motor 204 drives the diamond-shaped telescopic unit 203 to contract (contraction rate 2 mm / s), increasing the volume of the corrugated silicone airbag 201 and reducing the negative pressure value; if the pressure is more than 10 mmHg lower than the target value, the micro linear motor 204 extends (extension rate 2 mm / s), reducing the volume of the corrugated silicone airbag 201 and increasing the negative pressure value. Simultaneously, a pressure compensation algorithm is adopted: Pactual = Pset - K × ΔP (where Pactual is the actual output pressure, Pset is the stage target pressure, K is the compensation coefficient with a value of 0.8-1.2, and ΔP is the pressure difference between adjacent sensors). For example, when Pset is -100 mmHg, ΔP = 20 mmHg, and K = 1.0, Pactual = -100 - 1.0 × 20 = -120 mmHg. When the pressure difference between adjacent sensors ΔP > 15 mmHg, the stroke of the corresponding micro linear motor 204 is adjusted (0.1 mm stroke is adjusted for every 1 mmHg pressure difference) to achieve local pressure equalization. The target negative pressure and mode for each stage are as follows: exudative stage -125±15 mmHg (continuous suction), inflammatory stage -100±10 mmHg (intermittent suction: suction for 120 seconds, pause for 60 seconds), proliferative stage -75±5 mmHg (intermittent suction: suction for 60 seconds, pause for 120 seconds), remodeling stage -50±5 mmHg (pulse suction: frequency 0.5 Hz, amplitude ±10 mmHg).

[0045] During phototherapy, the dual-wavelength LED module 301 is activated based on the analysis results of the multimodal data processing unit 504. Tissue repair is assessed using Hb and SpO2: low perfusion (Hb < 80 g / L, SpO2 < 85%), normal perfusion (Hb 80-120 g / L, SpO2 85-95%), and high metabolism (Hb > 120 g / L, SpO2 > 95%). During the exudative or inflammatory phase, the blue light emitting unit 302 (450-470 nm) operates at a power density of 40-60 mW / cm² for 15-30 minutes (sterilization mode); during the proliferative or remodeling phase, the blue light power density decreases to 20-40 mW / cm², and irradiation is performed for 10-15 minutes (anti-inflammatory mode). The red light emitting unit 303 (620-640nm) irradiates for 10-20 minutes at a power density of 30-50mW / cm² when Hb < 100g / L (promoting angiogenesis); when Hb 100-120g / L, the power density is increased to 50-80mW / cm², irradiating for 8-15 minutes (promoting collagen synthesis). The light is transmitted via the optical fiber 104, focused by the parabolic micro-reflector 107 at the end, and projected onto the wound surface (the focal point coincides with the emitting surface). The flexible heating film 304 works synchronously; when the wound temperature is < 35℃, the red light power increases by 10-20mW / cm² (an increase of 5mW / cm² for every 1℃ decrease); when the temperature is > 39℃, the Peltier heat dissipation module 306 (set temperature 37±0.5℃) is activated, dissipating heat at 5W until the temperature returns to normal (an increase of 1W heat dissipation power for every 0.5℃ increase). The irradiation frequency is as follows: 3-4 times a day during the exudative phase (with an interval of 6-8 hours, such as 8:00, 14:00, 20:00); 2-3 times a day during the inflammatory phase (with an interval of 8-12 hours, such as 9:00, 18:00); 1-2 times a day during the proliferative phase (with an interval of 12-24 hours, such as 10:00); and once every other day during the remodeling phase (such as 8:00 on Monday and 8:00 on Wednesday).

[0046] In terms of exudate management, wound exudate flows into gradient filtration unit 401 through a flexible catheter. When the flow rate is ≤5mL / min, the exudate passes through primary filter 402 (100-150μm), secondary filter 403 (50-80μm), and tertiary filter 404 (20-30μm) in sequence, with a 10-15mm gap between adjacent filters for ultraviolet irradiation. The UVC lamp tube 405 (254nm, 10-20W) operates according to the dosage formula D=I×t (where D is the bactericidal dose in J / cm²; I is the UV light intensity in mW / cm²; and t is the irradiation time in seconds). The default settings are I=5mW / cm² and t=120s (i.e., D=6mJ / cm²), corresponding to inactivation rates of: Staphylococcus aureus 90% (requires 4mJ / cm²), Escherichia coli 99% (requires 6mJ / cm²), and Pseudomonas aeruginosa 90% (requires 6mJ / cm²). When the flow rate is >5 mL / min, the bypass channel opens to divert 20-30% of the flow (20% diversion when the flow rate is 5-10 mL / min, and 30% diversion when the flow rate is >10 mL / min). The piezoelectric vibrator 408 vibrates at a frequency of 50 Hz (amplitude 0.1 mm), and the backwash nozzle 409 washes the filter screen every 30 minutes at a pressure of 0.2-0.3 MPa (each wash lasts 10 seconds, sequentially from the first-stage filter to the third-stage filter). If Pseudomonas aeruginosa is detected, the irradiation time of the UVC lamp 405 is extended to 240 seconds (i.e., D=12 mJ / cm², achieving 99% inactivation). When the flow rate is >10 mL / min, I increases to 8 mW / cm². Every 10 hours of cumulative operation, the enhanced sterilization mode is automatically activated (I=10 mW / cm², t=300 s, with the drainage closed for 30 seconds to focus on sterilization).

[0047] The multimodal data processing unit 504 calculates a comprehensive score using the wound condition scoring system S=0.3×P+0.2×T+0.2×pH+0.15×Hb+0.15×SpO2 (where S is the comprehensive wound score, P is the pressure parameter (-150 to -50 mmHg corresponds to 30-90 points), T is the temperature parameter (35-39℃ corresponds to 40-80 points), and pH is the acidity / alkalinity parameter (5.5-7.5 corresponds to 30-90 points). Hb is the hemoglobin concentration parameter (60-140 g / L corresponds to 30-90 points), SpO2 is the oxygen saturation parameter (80%-100% corresponds to 40-80 points), and 0.3, 0.2, 0.2, 0.15, and 0.15 are the weighting coefficients for each parameter. S < 40 points corresponds to the exudative phase mode, 40 ≤ S < 60 points corresponds to the inflammatory phase mode, 60 ≤ S < 80 points corresponds to the proliferative phase mode, and S ≥ 80 points corresponds to the remodeling phase mode. When the score change rate is > 5% / hour, the system completes the parameter smooth transition within 30 minutes (e.g., when the negative pressure is adjusted from -100 mmHg to -75 mmHg, it decreases by 5 mmHg every minute, and is completed in 5 steps within 30 minutes: -100 → -95 → -90 → -85 → -80 → -75). The system operates in two modes: automatic (data is collected every 15 minutes, parameters are updated hourly, and an automatic alarm (audible and visual alarm, lasting 30 seconds, repeating every 1 minute) is triggered when the pressure deviation is >±20mmHg or the temperature is >40℃) and manual (allowing medical personnel to set fixed parameters, limiting pressure to <-200mmHg and temperature to >42℃ (automatic output cut-off when these are exceeded)). Safety mechanisms include: dual pressure protection (mechanical safety valve opening pressure -200mmHg; automatic shutdown when three consecutive sampled values ​​exceed the set value by ±30% (e.g., if the target is -100mmHg, shutdown when three consecutive values ​​are >-70mmHg or <-130mmHg)); and temperature protection (reducing light power by 20% when >39℃; shutting off the heating element when >41℃; and emergency shutdown (cutting off all outputs and triggering an alarm) when >42℃).

[0048] When the patient needs to change the dressing or stop treatment, pressing the "Stop" button on the control module 503 operation panel will first shut down the dual-wavelength LED module 301 and UVC lamp 405. Then, the micro linear motor 204 will release the negative pressure in the corrugated silicone airbag 201 to 0 at a rate of 10 mmHg / min (e.g., if the current pressure is -100 mmHg, it will drop to 0 after 10 minutes). Subsequently, the magnetic quick-connect slot 506 will be disconnected (by applying a 5-10 N pulling force), and the multi-layer composite dressing substrate 1 will be gently peeled off from the periphery to the center (peeling speed <5 cm / s) to complete the operation.

[0049] In this embodiment, since the entire device needs to be used continuously for 24 hours, a replaceable rechargeable battery is fixedly installed inside the waterproof shell 502 on the side wall of the intelligent negative pressure chamber 2 to power the entire device. The rechargeable battery has a full charge time of 12 hours, so the patient only needs to replace the battery once every 12 hours.

[0050] In this embodiment, the quartz protective tube 406 has an outer diameter of 6mm, an inner diameter of 4mm (wall thickness of 1mm), and a total length of 80mm, which can be well adapted to daily wear, ensuring that there is no obvious bulge when wearing ordinary clothes, and that the patient's daily activities and dressing are not hindered.

[0051] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A smart dynamic negative pressure and phototherapy integrated burn wound treatment device, characterized in that: The product includes a multi-layer composite dressing substrate, which is composed of a contact layer, a conductive layer and a support layer stacked in sequence. The contact layer is fixed to the lower surface of the support layer by a snap-fit ​​structure. The conductive layer includes a mesh structure formed by interlacing optical fibers and shape memory alloy wires. The support layer is a honeycomb polymer film. An intelligent negative pressure chamber is fixedly provided on the upper surface of the support layer. A photothermal coupling therapy component is integrated between the conductive layer and the support layer. The photothermal coupling therapy component includes a dual-wavelength LED module and a flexible heating film. It also includes a real-time sterilization exudate management system, which is composed of a gradient filtration unit and a pulsed ultraviolet module coaxially connected. A miniature flow sensor is integrated between the outlet of the intelligent negative pressure chamber and the gradient filtration unit. It also includes an intelligent control system, which includes a differential pressure sensor array, a temperature sensor, a pH sensor, a near-infrared spectrometer, and a control module fixedly installed at the bottom of the multilayer composite dressing substrate. The control module is connected to the differential pressure sensor array, the temperature sensor, the pH sensor, the near-infrared spectrometer, and the miniature flow sensor, respectively. The intelligent negative pressure chamber includes a corrugated silicone airbag, a deformable frame, and a dynamic adjustment module. The corrugated silicone airbag is fixedly disposed on the upper surface of the support layer. The deformable frame is fixedly disposed inside the corrugated silicone airbag and is sealed to the upper surface of the support layer through the corrugated silicone airbag. The deformable frame is composed of rhomboid telescopic units, which are made of hinged shape memory alloy sheets. The dynamic adjustment module includes a miniature linear motor for driving the deformation of the corrugated silicone airbag. The light from the dual-wavelength LED module is focused onto the wound surface by a parabolic micro-reflector at the end of the optical fiber, and the flexible heating film is attached to the lower surface of the support layer and fixed with thermally conductive adhesive. The gradient filtering unit is connected to the bottom of the corrugated silicone airbag via a flexible conduit, and the pulsed ultraviolet module includes a UVC lamp tube spirally wound around the outer wall of the conduit. The differential pressure sensor array and temperature sensor are embedded and distributed at the edge of the dressing substrate. The differential pressure sensor array and temperature sensor are electrically connected to the control module through shielded signal lines. The control module is embedded in the waterproof housing on the side wall of the intelligent negative pressure chamber. The light guide fiber and shape memory alloy wire are interwoven at a 30° helix angle. The surface of the light guide fiber is coated with a silver nanoparticle antibacterial coating. The end of the light guide fiber is fixed to the parabolic micro-reflector through a slot. The focal point of the parabolic micro-reflector coincides with the light-emitting surface of the dual-wavelength LED module. The gradient filtration unit is composed of three titanium alloy filters connected in series through the flexible conduit, with a UV irradiation gap maintained between adjacent filters. The UVC lamp tube and the quartz protective tube are coaxially nested, and the outer wall of the quartz protective tube is provided with heat dissipation fins. The multilayer composite dressing substrate is provided with magnetic quick-connect slots at its edge. The slots of adjacent dressing units are connected by magnetic attraction to form a continuous air path, optical path and circuit channel.

2. The intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device according to claim 1, characterized in that: The diamond-shaped telescopic unit is driven by the micro linear motor, and the output shaft of the micro linear motor is rigidly connected to the inner wall of the corrugated silicone airbag. The corrugated silicone airbag is provided with a pressure balance channel.

3. The intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device according to claim 1, characterized in that: The dual-wavelength LED module includes blue light and red light emitting units, which are alternately stacked with the flexible heating film via a flexible circuit board. The edge of the flexible heating film is bonded and fixed to the support layer with medical adhesive.

4. The intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device according to claim 2, characterized in that: The differential pressure sensor array is arranged in a ring around the outer periphery of the dressing substrate, with a spacing of 10-15 mm between adjacent sensors. The surface of the differential pressure sensor is covered with a medical-grade hydrophobic membrane and sealed and fixed with epoxy resin.

5. The intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device according to claim 1, characterized in that... The control module integrates a multimodal data processing algorithm, receives signals from the differential pressure sensor array, temperature sensor, and pH sensor in real time, and dynamically adjusts the stroke of the micro linear motor, the power of the dual-wavelength LED module, and the pulse frequency of the UVC lamp tube through a PID controller.

6. The intelligent dynamic negative pressure and phototherapy integrated burn wound treatment device according to claim 1, characterized in that... The support layer and the conductive layer are connected by ultrasonic welding.

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