Real-time intelligent pressure monitoring scar diagnosis and treatment device and system

Abstract

The invention relates to a real-time intelligent pressure monitoring scar diagnosis and treatment device and system. The device comprises a pressure generation device, a rigid structure matched with the pressure generation device in shape and a flexible touch sensor located in the rigid structure. The inner layer of the flexible touch sensor is provided with a flexible conductive contact array, and the outer layer of the flexible touch sensor is provided with a flexible integrated electrode array. According to the device, the local pressure borne by the pathological scar is accurately measured at the micro-nano scale, adjustment can be carried out in real time according to the stress condition, treatment of the pathological scar is facilitated, pressure research on the pathological scar is also facilitated, the pathogenesis of the pathological scar is clarified, and the device has good application prospects.

Description

Technical Field

[0001] This invention belongs to the field of scar treatment technology, and specifically relates to a real-time intelligent pressure monitoring scar diagnosis and treatment device and system. Background Technology

[0002] Scars are characterized by excessive production and deposition of collagen and other connective tissues in the dermis, including hypertrophic scars and keloids, and are the result of an excessive healing response to trauma. Clinically, they present with sensory abnormalities, tumor-like hyperplasia, and varying degrees of functional impairment. Histologically, they are characterized by abundant fibroblast proliferation, angiogenesis, increased inflammatory cells, increased fibroblasts and myofibroblasts, excessive deposition of collagen, proteoglycans, and glycoproteins in the extracellular matrix, and disordered collagen fiber arrangement.

[0003] Based on the above characteristics, the current treatments in this area include the following: (1) Local injection therapy, including the application of glucocorticoids with anti-inflammatory, fibroblast proliferation-inhibiting, and collagen synthesis-reducing effects; botulinum toxin type A with the ability to inhibit muscle fiber contraction, nerve paralysis, and reduce neurovascular effects; verapamil, a calcium channel blocker that inhibits angiogenesis and promotes fibroblast apoptosis; antitumor drugs that promote fibroblast and myofibroblast apoptosis; angiotensin-converting enzyme inhibitors with anti-inflammatory and anti-proliferative effects; and interferon that inhibits collagen synthesis and fibroblast proliferation; (2) Topical drug therapy, including silicone gel that can regulate signal transduction between fibroblasts and keratinocytes through hydration; immunosuppressants and traditional Chinese medicine therapy; (3) Physical therapy, including compression therapy that induces hypoxia through compression, inhibiting the proliferation of scar fibroblasts and collagen synthesis; and the use of heat to induce inflammation, promote vascular permeability, MMP production and collagen bundle decomposition, and targeted vascular destruction to inhibit angiogenesis and fibroblast proliferation, reduce collagen deposition, and reduce scar tissue. Laser treatment to reduce scar tissue thickness; radiotherapy to inhibit inflammation, fibroblast proliferation and angiogenesis, and cryotherapy to destroy fibroblasts and capillaries, promote collagen fiber degeneration, and inhibit fibroblast proliferation; micro-plasma radiofrequency therapy to generate multiple controllable micro-perforations on the skin by stimulating plasma sparks with monopolar radiofrequency technology, thereby generating high temperature and promoting collagen fiber degeneration in the dermis; hyperbaric oxygen therapy to reduce inflammatory response by increasing local tissue oxygen content; wax therapy to soften scars, reduce local tension, and relieve pain by transferring heat to scar tissue through heat conduction; (4) other emerging treatments, such as local transplantation of fat-derived mesenchymal stem cells to reduce the expression of extracellular matrix-related genes and proteins and inhibit cell proliferation by secreting a variety of cytokines and anti-fibrotic factors; gene therapy to regulate gene expression at the transcriptional and post-transcriptional levels through various long non-coding RNAs, participating in chromosome modification, DNA synthesis, cell differentiation and apoptosis; (5) treatment by surgical excision of scars, etc.

[0004] Currently, although there are numerous methods for scar treatment, and multiple methods are often used in combination in clinical practice, they still cannot meet the needs of patients. Among them, pressure therapy is the earliest developed, relatively well-researched, least invasive, more reliable, and more widely used. However, current pressure therapy still has room for improvement, such as the lack of understanding of whether precise pressure is applied to the scar area, the degree and extent of pressure, and the direct link between precise local pressure and functional improvement. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a real-time intelligent pressure monitoring scar diagnosis and treatment device and system, which solves the problem of the lack of precise pressure on the local area of ​​scars and the degree and range of pressure in the existing technology.

[0006] This invention provides a real-time intelligent pressure monitoring scar treatment device, the device comprising a pressure generating device, a rigid structure matching the shape of the pressure generating device, and a flexible tactile sensor located inside the rigid structure; the inner layer of the flexible tactile sensor is provided with a flexible conductive contact array, and the outer layer is provided with a flexible integrated electrode array.

[0007] Preferably, the rigid structure is made of non-woven fabric, plastic film, or other chemical fiber materials.

[0008] Preferably, the flexible conductive contact array is fabricated using Ecoflex 0010.

[0009] Preferably, the flexible conductive contact array and the flexible integrated electrode array are made of the same material and are encapsulated to obtain a flexible tactile sensor.

[0010] Preferably, the flexible tactile sensor is electrically interconnected with the flexible circuit board (FPC).

[0011] Preferably, the pressure monitoring range of the device is 60 mmHg, or a more suitable pressure is adopted according to the different scars.

[0012] This invention also provides a real-time intelligent pressure monitoring scar treatment system, comprising the aforementioned device, a signal acquisition and processing module, a Bluetooth module, and a visualization interface. The signal acquisition and processing module is used to acquire signals generated by the real-time intelligent pressure monitoring scar treatment device; the Bluetooth module is used for wireless transmission of data generated by the signal acquisition and processing module; and the visualization interface is used to display 2D and 3D pressure cloud maps and record and store data.

[0013] Beneficial effects

[0014] This invention precisely measures the pressure exerted on the local area of ​​pathological scars at the micro-nano scale and can adjust the pressure in real time according to the stress conditions. This is not only beneficial for the treatment of pathological scars, but also for conducting pressure research on pathological scars, elucidating the pathogenesis of pathological scars, and has good application prospects. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of the real-time intelligent pressure scar diagnosis and treatment monitoring device of the present invention.

[0016] Figure 2 A finite element model for scar pressure therapy is provided; where (a) is the geometric shape and (b) is the mesh generation.

[0017] Figure 3 The distribution of elastic modulus between normal skin and scars.

[0018] Figure 4 This is a flowchart illustrating the fabrication process of the flexible conductive contact array of the present invention.

[0019] Figure 5 This is a flowchart illustrating the assembly process of the flexible tactile sensor of the present invention.

[0020] Figure 6 (a) shows the interconnection process between the flexible tactile sensor and the flexible circuit board (FPC) of the present invention; (b) is a physical image.

[0021] Figure 7 Photograph of a scar treatment system based on the real-time intelligent pressure scar treatment monitoring device of the present invention.

[0022] Figure 8 Photographs showing the application of a scar treatment system to rabbit ear scars.

[0023] Figure 9 Pressure distribution on rabbit ear scars under different pressures: (a) 20 mmHg; (b) 40 mmHg; (c) 60 mmHg. Detailed Implementation

[0024] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0025] Example 1

[0026] This invention provides a real-time intelligent pressure monitoring scar treatment device, the device comprising a pressure generating device, a rigid structure matching the shape of the pressure generating device, and a flexible tactile sensor located inside the rigid structure; the inner layer of the flexible tactile sensor is provided with a flexible conductive contact array, and the outer layer is provided with a flexible integrated electrode array.

[0027] Taking the treatment process for scars on the arm as an example, such as Figure 1 As shown, an inflatable cuff is used as a pressure generating device to apply a uniformly distributed load. A flexible tactile sensor and a rigid, arc-shaped structure matching the curvature of the arm are placed between the scar and the cuff. This device has dual functions of scar treatment and pressure monitoring. On one hand, the sensor's hemispherical flexible conductive contact can more effectively transmit pressure to the scar interface, helping to improve scar growth morphology. On the other hand, the 8×8 sensing array can monitor the scar pressure distribution at 64 different locations with a pixel pitch of 6 mm in real time. This allows the treatment pressure to be more precisely controlled within a suitable range, ultimately achieving the goal of scar treatment.

[0028] A physical model for scar pressure treatment was established using the finite element method, and the force problems in the model were studied in depth using the solid mechanics module of COMSOL Multiphysics software. First, the geometric and material properties of the model were defined. For example... Figure 2 As shown, the compressive elastic modulus of the skin was measured. Figure 3 The model's cross-sectional structure was simulated and analyzed using finite element methods. The study also investigated the role of flexible contacts in pressure transmission and the influence of scar morphology on stress distribution. The results showed that flexible contact arrays fabricated with Ecoflex 0010 are more prone to deformation, have higher sensitivity, and can transmit more pressure information from the scar surface. Furthermore, the changes in scar width and height directly affect surface curvature; scars with greater curvature exhibit more significant differences in pressure and contact radius at the center / edge. The relationship between contact radius and pressure response also indicates that differences in response current between regions are more pronounced.

[0029] The method for fabricating the flexible tactile sensor includes the following steps:

[0030] (1) Fabrication process of flexible conductive contact array: such as Figure 4 As shown, an 8×8 array of flexible contacts was fabricated using a mold. Ecoflex 0010 was poured into the mold after spraying and cured at room temperature to obtain the flexible conductive contact array.

[0031] (2) Fabrication process of flexible integrated electrode array: The fabrication process includes two parts: PDMS bionic contacts and MIEs electrodes. The fabrication process of PDMS bionic contacts is as follows: propylene glycol methyl ether acetate (PGMEA) and multi-walled carbon nanotubes (MWCNTs, Beijing Deke Daojin Science and Technology Co., Ltd.) are mixed at a ratio of 10 mL: 1 g and dispersed evenly under ultrasound. The dispersion is drop-coated onto the surface of the mold and heated on a heating platform at 50°C in a fume hood for 30 min until the PGMEA solvent is completely evaporated. The flexible material is poured onto the mold and degassed in a vacuum environment. Finally, it is cured and peeled off from the mold to obtain a flexible top electrode with a certain curvature and an embedded MWCNTs conductive layer. This composite material has good conductivity and bonding strength.

[0032] Compared to a single bottom electrode structure, the manufacturing process of integrated electrode MIEs adds an upper electrode patterning step. Physical examples of MIEs with different distribution densities and PDMS biomimetic contacts with various radii of curvature are shown.

[0033] (3) Assembly process of tactile sensor array: After the contacts and integrated electrodes are fabricated separately, they need to be tightly assembled. Considering the symmetry of the overall structure, Figure 5 The assembly process was described from the perspective of a single sensing unit. First, a 50 μm thick Ecoflex 0010 film was spin-coated onto a clean Si or SiO2 substrate. Then, the prepared integrated electrode was attached to the film surface, and a flexible conductive contact array was aligned with it. Micropillars were inserted through the patterned window of the PI film, aligned with the Ecoflex 0010 encapsulation layer, and cured at room temperature to form a complete package. Because the encapsulation layer and the contact array are made of the same material, the connection strength is higher than that of encapsulation methods using dissimilar materials.

[0034] (4) Interconnection and Packaging: After the sensor is packaged, it needs to be electrically interconnected with the flexible printed circuit board (FPC). For example... Figure 6 As shown, the pads on the sensor array are aligned with the FPC pads. The two are connected with conductive silver paste and then encapsulated with silicone after curing. The FPC terminal connectors are connected to the signal acquisition / processing circuit.

[0035] Example 2

[0036] like Figure 7As shown, this embodiment provides a real-time intelligent pressure monitoring scar treatment system, comprising the device described in Embodiment 1, a signal acquisition and processing module, a Bluetooth module, and a visualization interface. The signal acquisition and processing module is used to acquire signals generated by the real-time intelligent pressure monitoring scar treatment device; the Bluetooth module is used for wireless transmission of data generated by the signal acquisition and processing module; the visualization interface is used to display 2D and 3D pressure cloud maps and record and store data. The signal acquisition and processing module and the Bluetooth module are based on an improved FDH64 hardware system, and the visualization interface is based on an improved DFPM_B software system.

[0037] A scar treatment system was installed on the ear of anesthetized experimental rabbits. A cuff and inflation device provided constant static pressure on the scar surface. A tactile sensor array was positioned between the scar and the cuff to achieve real-time pressure detection. Figure 8 As shown.

[0038] In addition to the power and charging indicator lights, the control interface features three buttons for easy switching of the hardware system's operating modes. These are:

[0039] (1) Button 1 is the system button and indicator light. The system mode indicator light is red. Press and hold this system button for more than 3 seconds to power on the device and the system light will illuminate. The default power-on mode is wired communication mode. If the device is in other modes and you want to switch to wired mode, simply press this button briefly to enter wired communication mode. Press and hold this button for more than 3 seconds to power off the device.

[0040] (2) Button 2 is the WIFI mode button and indicator light. The WIFI mode indicator light is yellow. Pressing this button switches the device to WIFI mode, and the indicator light flashes rapidly. When the WIFI connection is successful, the indicator light flashes slowly (about once per second). At this time, the device can communicate with the host computer via WIFI.

[0041] (3) Button 3 is the SD card mode button and indicator light. The SD card mode indicator light is green. Pressing this button switches the device to SD card mode, and the SD card mode indicator light flashes rapidly. When the SD card is initialized and a new file is successfully created, the indicator light turns to slow flashing (about once per second). At this time, the device has successfully entered SD card mode.

[0042] Figure 9This study demonstrates the actual pressure values ​​at the rabbit ear scar under three pressure levels: 20 mmHg, 40 mmHg, and 60 mmHg. When the average pressure was 20 mmHg, the peak pressure values ​​at the two scar sites were 35.4 kPa and 61.5 kPa, with a center-to-center distance of 33.6 mm. When the average pressure increased to 40 mmHg, the peak pressure values ​​were 102 kPa and 106.8 kPa, with a center-to-center distance of 30.6 mm. At an average pressure of 60 mmHg, the peak pressure values ​​were 225.9 kPa and 245.8 kPa, with a center-to-center distance of 27.7 mm. The tactile sensor array accurately displayed the actual pressure values ​​at the scar coordinates, spacing, morphology, and interface. These results indicate that the tactile sensor array plays a role in pressure monitoring and treatment efficacy evaluation in a rabbit ear hypertrophic scar model, providing valuable technical support and theoretical basis for real-time pressure monitoring and clinical treatment of scars. Furthermore, combining real-time pressure detection and application methods can lead to better scar treatment.

Claims

1. A real-time intelligent pressure monitoring scar treatment device, characterized in that: The device comprises a pressure generating device, a rigid structure matching the shape of the pressure generating device, and a flexible tactile sensor inside the rigid structure; the inner layer of the flexible tactile sensor is provided with a flexible conductive contact array, and the outer layer is provided with a flexible integrated electrode array.

2. The real-time intelligent pressure monitoring scar diagnosis and treatment device according to claim 1, characterized in that: The material of the rigid structure is non-woven fabric, plastic film or other chemical fiber materials.

3. The real-time intelligent pressure monitoring scar diagnosis and treatment device according to claim 1, characterized in that: The flexible conductive contact array is prepared from Ecoflex 0010.

4. The real-time intelligent pressure monitoring scar diagnosis and treatment device according to claim 1, characterized in that: The flexible conductive contact array and the flexible integrated electrode array are prepared from the same material, and the flexible tactile sensor is obtained by encapsulation.

5. The real-time intelligent pressure monitoring scar diagnosis and treatment device according to claim 1, characterized in that: The flexible tactile sensor is electrically interconnected with a flexible circuit board FPC.

6. The real-time intelligent pressure monitoring scar diagnosis and treatment device according to claim 1, characterized in that: The pressure monitoring range of the device is 60 mmHg or a more suitable pressure according to different scars.

7. A real-time intelligent pressure monitoring scar diagnosis and treatment system, characterized in that: The device is composed of the device of claim 1, a signal acquisition and processing module, a Bluetooth module, and a visual interface.

8. The real-time intelligent pressure monitoring scar diagnosis and treatment system according to claim 7, characterized in that: The signal acquisition and processing module is used to acquire the signals generated by the real-time intelligent pressure monitoring scar diagnosis and treatment device; the Bluetooth module is used to wirelessly transmit the data generated by the signal acquisition and processing module; and the visual interface is used to display the 2D and 3D pressure cloud maps of the interface, and record and store the data.

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