Anti-colorectal adhesion monitoring patch and monitoring system thereof

Abstract

The invention relates to an anti-colorectal adhesion monitoring patch and a monitoring system thereof, which are characterized in that the anti-colorectal adhesion monitoring patch and an in-vitro wireless monitoring terminal which are wirelessly connected are arranged, the anti-colorectal adhesion monitoring patch is of a three-layer membrane structure which is tightly connected, and the three-layer membrane structure sequentially comprises an anti-adhesion layer, a monitoring layer and a supporting layer from outside to inside; the anti-adhesion layer is used for physically blocking other tissues of a human body, such as an intestinal canal and a peritoneum, from being in direct contact with a surgical wound surface; the monitoring layer is used for capturing a deformation signal generated when the membrane body is pulled when tissues in the abdominal cavity are adhered in real time; the supporting layer is used for fixing the structures of the anti-adhesion layer and the monitoring layer; and the in-vitro wireless monitoring terminal is used for monitoring the abdominal cavity adhesion condition of the target person in real time according to the electric signal from the monitoring layer, and early warning in time when the abdominal cavity adhesion condition of the target person is monitored. The device has the effect that the effective combination of the biodegradable anti-adhesion function and the non-invasive adhesion monitoring function can be realized.

Description

Technical Field

[0001] This invention relates to the field of medical prevention and treatment technology, and in particular to a monitoring patch for preventing colorectal adhesions and its monitoring system. Background Technology

[0002] Following colorectal surgery, such as radical resection of colon cancer or lysis of intestinal obstruction, intra-abdominal tissues such as the intestines, peritoneum, and organ surfaces are prone to "abdominal adhesions" due to surgical trauma, with an incidence rate as high as 60%-90%. Mild adhesions may not have obvious symptoms, while severe adhesions can lead to chronic abdominal pain, intestinal obstruction, and even require a second surgery, namely adhesiolysis. This not only prolongs the patient's hospital stay by an average of 3-5 weeks but also increases the postoperative complication rate by 40%.

[0003] Current methods for preventing and treating abdominal adhesions have some key drawbacks. First, the anti-adhesion effect is limited and lacks active monitoring: existing technologies mainly rely on "passive physical isolation," such as the use of anti-adhesion membranes like hyaluronic acid membranes and oxidized regenerated cellulose membranes. These membranes can only physically block tissue contact in the early postoperative period, but cannot determine in real time whether adhesions have occurred. If the membrane shifts or degrades too quickly, adhesions may still form. Moreover, medical staff can only detect these adhesions 2-4 weeks after surgery through imaging examinations such as CT scans and ultrasound. By this time, adhesions have already formed, and the opportunity for early intervention has been missed.

[0004] Secondly, the monitoring methods are outdated, resulting in a high misdiagnosis rate: In the early stage of postoperative adhesions, namely 3-7 days after surgery, there are no specific symptoms. Imaging examinations such as CT scans are difficult to identify the main component of early adhesions, namely "fibrinous adhesions," and can only detect "mechanical adhesions" that have caused intestinal dilation, with a misdiagnosis rate of over 30%. Although endoscopic examinations such as laparoscopic exploration can confirm the diagnosis, they are invasive procedures with high risks, such as intestinal damage, and cannot be used as a routine monitoring method.

[0005] Finally, there is a mismatch between biocompatibility and degradation cycle: some anti-adhesion products, such as synthetic polymer membranes, have a degradation cycle that is too long (>4 weeks), which may conflict with the tissue healing process and lead to foreign body reaction; some products degrade too quickly (<1 week), which cannot cover the high-incidence period of adhesion, namely 1-2 weeks after surgery, thus reducing the anti-adhesion effect.

[0006] The shortcomings of existing technologies: Existing anti-adhesion products and monitoring methods are completely separate, and anti-adhesion products can only passively block adhesion and cannot actively warn of adhesion risks. They are difficult to meet the needs of "active prevention-early detection-timely intervention" after colorectal surgery. Therefore, there is an urgent need for a dual-effect device that integrates "biodegradable anti-adhesion" and "non-invasive adhesion monitoring" functions. Summary of the Invention

[0007] The present invention provides an anti-colonic adhesion monitoring patch and its monitoring system, which can effectively combine the dual functions of "biodegradable anti-adhesion" and "non-invasive adhesion monitoring".

[0008] To achieve the above objectives, the present invention provides an anti-colonic adhesion monitoring patch, the key feature of which is: a tightly connected three-layer membrane structure, consisting of an anti-adhesion layer, a monitoring layer, and a support layer from the outside to the inside. The anti-adhesion layer and the support layer are the same size, and the monitoring layer is smaller than the size of the anti-adhesion layer and the support layer. The anti-adhesion layer and the support layer are bonded together around their perimeters, completely clamping the monitoring layer between them.

[0009] The monitoring layer integrates a monitoring circuit, which includes a micro strain sensor array, a signal conditioning circuit, a main control unit, and a transmission module.

[0010] The micro strain sensor array is provided with m micro strain sensors arranged in an array. The output terminals of all micro strain sensors are connected to the input terminal of the signal conditioning circuit. The output terminal of the signal conditioning circuit is connected to the input terminal of the main control unit. The output terminal of the main control unit is connected to the input terminal of the transmission module. The output terminal of the transmission module is provided with a degradable flexible antenna.

[0011] With the above design, after the patient's surgery, the anti-colonic adhesion monitoring patch is attached to areas with high adhesion rates, such as around the colorectal anastomosis and surgical wound, through the support layer. When adhesion occurs in the abdominal cavity, the membrane of the anti-colonic adhesion monitoring patch will deform under tension. The micro-strain sensor in the monitoring layer captures the strain signal generated by the membrane deformation in real time, and then outputs the monitoring signal through the transmission module.

[0012] The anti-adhesion layer, monitoring layer, and support layer are all made of biodegradable materials, with a degradation cycle that precisely matches the high-incidence period of adhesion, i.e., 14±2 days, effectively improving the anti-adhesion effect of the patch. At the same time, the monitoring layer can also accurately monitor the postoperative abdominal adhesion status of patients, realizing an effective combination of the dual functions of "biodegradable anti-adhesion" and "non-invasive adhesion monitoring".

[0013] Preferably, the anti-adhesion layer is a hyaluronic acid-chitosan composite hydrogel, on which anti-inflammatory factors are attached.

[0014] The anti-adhesion layer is used to physically block direct contact between other human tissues, such as the intestines and peritoneum, and the surgical wound, while slowly releasing "anti-inflammatory factors" to inhibit local inflammatory responses and reduce fibrin deposition.

[0015] The anti-adhesion layer uses "hyaluronic acid-chitosan composite hydrogel", which has high lubricity, a friction coefficient ≤0.05, and good tissue compatibility. It can physically block direct contact between the intestine, peritoneum and surgical wound, while slowly releasing "anti-inflammatory factors", such as interleukin-10, to inhibit local inflammatory response. Inflammation is a key inducing factor for adhesion formation, reducing fibrin deposition and improving the anti-adhesion effect.

[0016] Preferably, the monitoring layer is a biodegradable encapsulation film, on which a monitoring circuit is integrated;

[0017] The monitoring layer is used to capture the strain signal generated by the traction of the membrane when adhesion occurs in the abdominal cavity tissue in real time, and convert the strain signal into an electrical signal.

[0018] The biodegradable encapsulation film can prevent body fluids from penetrating the monitoring layer, ensuring the stable operation of the monitoring circuit.

[0019] Preferably, the biodegradable encapsulation film is a hyaluronic acid-gelatin composite film.

[0020] Preferably, the support layer is a polycaprolactone nanofiber membrane, and the outer surface of the polycaprolactone nanofiber membrane is covered with a medical bio-adhesive coating.

[0021] The support layer adheres to the wound surface and is used to fix the anti-adhesion layer and the monitoring layer, so that the anti-colonic adhesion monitoring patch is attached to the area around the colorectal anastomosis and the surgical wound.

[0022] The support layer is made of "polycaprolactone nanofiber membrane", which has good mechanical strength and tensile strength ≥10MPa. It can fix the structure of the anti-adhesion layer and the monitoring layer, avoid membrane damage during surgical operation, and slowly degrade over time, with a degradation rate of ≥90% after 14 days. The degradation products are carbon dioxide and water, with no foreign matter residue.

[0023] By coating the edges of the supporting membrane with medical bio-adhesive, such as fibrin glue, the membrane can be directly adhered to areas prone to adhesion, such as around the colorectal anastomosis and surgical wound, during surgery, without the need for sutures, and the adhesion strength is ≥3N / m². It can withstand intestinal peristalsis traction, with a postoperative intestinal peristalsis frequency of 3-5 times / minute and membrane deformation ≤5%, which does not affect sensor monitoring.

[0024] Preferably, the monitoring circuit is further provided with a power supply module and a storage module, which are respectively connected to the control unit.

[0025] The power supply module is used to supply power to the other modules, and the storage module is used to store electrical signal data from the main control unit;

[0026] Each module of the monitoring circuit is made of biodegradable materials, and the modules are connected by biodegradable wires.

[0027] Preferably, the strain measurement range of a single micro-strain sensor is 0-20%, which covers the entire scenario of membrane deformation caused by abdominal adhesions. The specific correspondence is as follows:

[0028] 0-3% strain: Slight deformation of the membrane caused by normal physiological activities such as intestinal peristalsis and respiratory movements, with no risk of adhesion;

[0029] 3%-8% strain: Early fibrinous adhesions, adhesion area ≤0.5 Minor deformation caused by local tissue traction;

[0030] 8%-15% strain: moderate fibrous adhesion, adhesion area 0.5-1 The contraction of fibrous tissue leads to significant traction on the membrane;

[0031] 15%-20% strain: severe adhesion, adhesion area > 1 Or, the adhesions may have high traction tension, such as the continuous traction caused by adhesions between the intestine and the peritoneum, causing the membrane to approach its maximum tolerance deformation.

[0032] As a preferred option, the 14±2 day degradation cycle of the anti-colorectal adhesion monitoring patch begins after implantation and lasts for approximately 14 days until it is completely degraded into harmless products and absorbed by the body. The degradation process is as follows:

[0033] Postoperative days 0-7: The anti-adhesion layer, monitoring layer and support layer of the patch material only undergo slight hydrolysis / enzymatic degradation, with a degradation rate of ≤20%, and the core structure and function remain intact. The anti-adhesion layer can still physically block tissue contact and release anti-inflammatory factors, and the circuit performance of the monitoring layer is stable, with no attenuation in signal transmission and data processing.

[0034] 7-10 days post-surgery: The material degradation rate accelerates, reaching 30%-50%, but key functional modules such as the micro-strain sensor and main control unit still maintain their working capabilities. Only non-core areas such as the edge of the encapsulation film and the end of the lead wire show localized degradation.

[0035] Postoperative days 10-14: Degradation enters the accelerated phase, with a degradation rate of 50%-90%. The monitoring layer circuit gradually fails due to material disintegration, and the anti-adhesion layer and support layer structure collapse. Around 14 days, all materials are completely degraded, with a residual amount of ≤5%. Degradation products are excreted through metabolism or absorbed by tissues.

[0036] A monitoring system based on an anti-colonic adhesion monitoring patch, the key features of which are: an anti-colonic adhesion monitoring patch and an external wireless monitoring terminal connected to the anti-colonic adhesion monitoring patch via wireless communication;

[0037] The monitoring layer of the anti-colonic adhesion monitoring patch integrates a monitoring circuit, which includes a micro strain sensor array, a signal conditioning circuit, a main control unit, and a transmission module.

[0038] The micro strain sensor array is used to acquire strain signals from the membrane.

[0039] The signal conditioning circuit is provided with an amplifier, a filter and an analog-to-digital converter connected in sequence. The signal conditioning circuit is used to amplify, filter and convert the strain signal in sequence to obtain an electrical signal and transmit it to the main control unit.

[0040] The main control unit is used to send the electrical signal to the external wireless monitoring terminal through the transmission module;

[0041] The external wireless monitoring terminal is used to monitor the abdominal adhesion status of the target person in real time based on the electrical signal, and to issue an early warning when abdominal adhesion is detected in the target person.

[0042] Through the above design, the monitoring layer in the anti-colonic adhesion monitoring patch collects in vivo strain signals in real time. The external wireless monitoring terminal judges the abdominal adhesion status based on the strain signals and issues an adhesion warning based on the judgment result. This achieves accurate monitoring and timely warning of postoperative abdominal adhesions, enabling early detection and intervention in the early stages of adhesions, effectively avoiding the adverse effects of severe adhesions on patients.

[0043] As a preferred embodiment, the external wireless monitoring terminal is a portable waist-mounted monitoring terminal, which is used by the patient to hang on the waist after surgery and establish wireless communication with the monitoring layer of the internal anti-colonic adhesion monitoring patch.

[0044] The external wireless monitoring terminal integrates an adhesion determination algorithm module, which is connected to an LCD display, a miniature buzzer, and a Bluetooth module.

[0045] The LCD screen is used to display patient information and monitoring data;

[0046] The miniature buzzer is used for adhesion alarm;

[0047] The Bluetooth module is used to acquire the electrical signal and send warning information to the patient's family's mobile APP or the medical staff management platform.

[0048] Preferably, the adhesion determination algorithm module performs adhesion early warning through the following process:

[0049] Level 1 warning: When the adhesion determination algorithm module detects that the strain value (i.e., the electrical signal) of a single micro strain sensor is greater than 5% of the adhesion strain threshold for 1 hour, the external wireless monitoring terminal displays a "yellow warning", and the adhesion determination algorithm module controls the micro buzzer to provide a low-frequency prompt with a volume ≤35dB.

[0050] Level 2 warning: When the adhesion determination algorithm module detects that the strain values ​​of at least two micro strain sensors are greater than 8% of the adhesion strain threshold for 2 consecutive hours, the external wireless monitoring terminal displays an "orange warning", the adhesion determination algorithm module controls the micro buzzer to provide a mid-frequency prompt, and at the same time pushes the warning information to the patient's family's mobile APP via Bluetooth module;

[0051] Level 3 warning: When the adhesion determination algorithm module detects that the strain values ​​of at least three micro-strain sensors are greater than 12% of the adhesion strain threshold for 1 hour, the external wireless monitoring terminal displays a "red warning", the adhesion determination algorithm module controls the micro-buzzer to provide a high-frequency prompt, and at the same time sends an emergency alarm to the medical management platform via Bluetooth module.

[0052] The beneficial effects of this invention are as follows: This invention consists of two parts: an anti-colonic adhesion monitoring patch and an external wireless monitoring terminal. During surgery, the anti-colonic adhesion monitoring patch is applied to the patient's colorectal anastomosis and the area around the surgical wound. After surgery, the anti-colonic adhesion monitoring patch and the external wireless monitoring terminal work together to achieve anti-adhesion + real-time adhesion early warning 1-2 weeks after surgery, which can meet the needs of "proactive prevention - early detection - timely intervention" after colorectal surgery and reduce the patient's postoperative recovery period. Attached Figure Description

[0053] Figure 1 This is a schematic diagram of the anti-colonic adhesion monitoring patch structure in the embodiment;

[0054] Figure 2 This is a schematic diagram of the external wireless monitoring terminal in the embodiment;

[0055] Figure 3 The circuit diagram for the monitoring circuit in this embodiment is shown. Detailed Implementation

[0056] The present invention will be further described in detail below with reference to the accompanying drawings and specific examples. The following embodiments or drawings are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0057] like Figure 1As shown, a monitoring patch for preventing colorectal adhesions is a tightly connected three-layer membrane structure, consisting of an anti-adhesion layer a, a monitoring layer b, and a support layer c from the outside to the inside. The anti-adhesion layer a and the support layer c have the same size, while the monitoring layer b has a smaller size than the anti-adhesion layer a and the support layer c. The anti-adhesion layer a and the support layer c are bonded together around their perimeters, completely clamping the monitoring layer b between them.

[0058] The anti-adhesion layer a, monitoring layer b, and support layer c are all made of biodegradable materials, with a degradation cycle precisely matching the peak adhesion period of 14±2 days.

[0059] The anti-adhesion layer a uses "hyaluronic acid-chitosan composite hydrogel", which has high lubricity, a friction coefficient ≤0.05, and good tissue compatibility. It is used to physically block direct contact between other human tissues, such as the intestines and peritoneum, and the surgical wound. At the same time, it slowly releases "anti-inflammatory factors", such as interleukin-10, to inhibit local inflammatory response. Inflammation is a key inducing factor for adhesion formation, and it reduces fibrin deposition.

[0060] Hyaluronic acid-chitosan composite hydrogels are typically composed of cross-linked hyaluronic acid, cross-linked chitosan, prednisone, poloxamer, etc. Their composition can be expressed as: cross-linked hyaluronic acid (0.8-1.2%) - cross-linked chitosan (0.2-1.0%) - prednisone (0.01-0.05%) - poloxamer (2.0-6.0%), where the weight percentage range of each component is in parentheses.

[0061] The monitoring layer b is a biodegradable encapsulation film, on which a monitoring device is integrated. The monitoring device is used to capture in real time the deformation signal generated by the traction of the membrane when adhesion occurs in the abdominal cavity tissue, and converts the deformation signal into an electrical signal and sends it to the external wireless monitoring terminal. Figure 1 1 is a miniature strain sensor, and 4 is a transmission module.

[0062] The biodegradable encapsulation film is a hyaluronic acid-gelatin composite film.

[0063] Hyaluronic acid-gelatin composite films are made by mixing hyaluronic acid and gelatin in a specific solvent. Trifluoroethanol and deionized water are mixed at a volume ratio of 1:1-2 as the solvent. Hyaluronic acid accounts for 10%-40% of the total mass fraction of the solute, and gelatin accounts for 60%-90%. Its composition can be expressed as: hyaluronic acid (10%-40%) - gelatin (60%-90%), where the values ​​in parentheses represent the mass fraction range of each component in the solute.

[0064] The support layer c is made of polycaprolactone nanofiber membrane, and the outer surface of the polycaprolactone nanofiber membrane is covered with a medical bioadhesive coating. The support layer c is used to fix the structure of the anti-adhesion layer a and the monitoring layer b, so that the anti-colonic adhesion monitoring patch can be attached to high-adhesion areas such as around the colorectal anastomosis and surgical wound, to avoid membrane damage during surgical operations. At the same time, it slowly degrades over time, with a degradation rate of ≥90% after 14 days. The degradation products are carbon dioxide and water, with no foreign matter residue.

[0065] Polycaprolactone nanofiber membranes are generally formed by electrospinning polycaprolactone particles dissolved in a specific mixed solvent. The mixed solvent is prepared by mixing formic acid and acetic acid in a volume ratio of (30-70):(30-70). Its composition can be simply expressed as: polycaprolactone-formic acid-acetic acid, where polycaprolactone is the solute and formic acid and acetic acid are the solvents, in a ratio of (30-70):(30-70).

[0066] By coating the membrane edge of the support layer c with medical bio-adhesive, such as fibrin glue, the membrane can be directly adhered to areas prone to adhesion, such as around the colorectal anastomosis and surgical wound, during surgery, without the need for sutures, and the adhesion strength is ≥3N / m². It can withstand intestinal peristalsis traction, with a postoperative intestinal peristalsis frequency of 3-5 times / minute and membrane deformation ≤5%, which does not affect sensor monitoring.

[0067] like Figure 3 As shown, the monitoring layer b integrates a monitoring circuit D, which includes a micro strain sensor array 1, a signal conditioning circuit 2, a main control unit 3, a transmission module 4, a power supply module 5, and a storage module 31.

[0068] The array of miniature strain sensors 1 comprises m miniature strain sensors 1 arranged in an array. The output terminals of all miniature strain sensors 1 are connected to the input terminal of the signal conditioning circuit 2. The output terminal of the signal conditioning circuit 2 is connected to the input terminal of the main control unit 3. The output terminal of the main control unit 3 is connected to the input terminal of the transmission module 4. The output terminal of the transmission module 4 is equipped with a biodegradable flexible antenna. The power supply module 5 and the storage module 31 are respectively connected to the control unit.

[0069] The signal conditioning circuit 2 is provided with an amplifier 21, a filter 22 and an analog-to-digital converter 23 connected in sequence. The signal conditioning circuit 2 is used to amplify, filter and convert the deformation signal in sequence to obtain an electrical signal and transmit it to the main control unit 3.

[0070] The main control unit 3 is used to transmit the electrical signal to the external wireless monitoring terminal through the transmission module. The transmission module is based on ultra-wideband (UWB) technology, and the signal attenuation when penetrating human tissue is ≤5%.

[0071] The power supply module 5 is a biodegradable WeChat battery used to power the other modules.

[0072] The storage module 31 uses a degradable EEPROM to store electrical signal data from the main control unit 3.

[0073] Each module of the monitoring circuit D is made of biodegradable material, and the modules are connected by biodegradable wires made of magnesium-zinc alloy wires.

[0074] A monitoring system based on an anti-colonic adhesion monitoring patch includes the anti-colonic adhesion monitoring patch and an external wireless monitoring terminal connected to the anti-colonic adhesion monitoring patch via wireless communication. The external wireless monitoring terminal includes, for example,... Figure 2 As shown.

[0075] The monitoring layer b of the anti-colonic adhesion monitoring patch integrates a monitoring circuit D, which includes a micro strain sensor array 1, a signal conditioning circuit 2, a main control unit 3, and a transmission module 4.

[0076] The array of miniature strain sensors 1 is used to acquire strain signals from the membrane.

[0077] The signal conditioning circuit 2 is provided with an amplifier 21, a filter 22 and an analog-to-digital converter 23 connected in sequence. The signal conditioning circuit 2 is used to amplify, filter and convert the strain signal in sequence to obtain an electrical signal and transmit it to the main control unit 3.

[0078] The main control unit 3 is used to send the electrical signal to the external wireless monitoring terminal through the transmission module 4;

[0079] The external wireless monitoring terminal is used to monitor the abdominal adhesion status of the target person in real time based on the electrical signal, and to issue an early warning when abdominal adhesion is detected in the target person.

[0080] The external wireless monitoring terminal is a portable waist-mounted monitoring terminal, measuring 8cm in length × 5cm in width × 2cm in thickness, and weighing ≤60g. It is worn by the patient on the waist after surgery to establish wireless communication with the monitoring layer b of the internal anti-colonic adhesion monitoring patch. The effective wireless signal transmission distance of the external wireless monitoring terminal is ≤30cm, the battery life is ≥14 days, and it uses a rechargeable lithium battery.

[0081] The external wireless monitoring terminal is used to monitor the abdominal adhesion status of the target person in real time based on the electrical signal from the monitoring layer b, and to issue an early warning when abdominal adhesion is detected in the target person.

[0082] The external wireless monitoring terminal integrates an adhesion determination algorithm module, which is connected to a 1.0 LCD display, a miniature buzzer, and a Bluetooth module.

[0083] The LCD screen is used to display patient information and monitoring data;

[0084] The miniature buzzer is used for adhesion alarm;

[0085] The Bluetooth module is used to acquire the electrical signal and send warning information to the patient's family's mobile APP or the medical staff management platform.

[0086] The adhesion determination algorithm module sets a three-level warning threshold based on strain data transmitted by sensors. This warning threshold is trained using strain data from 300 patients with adhesions after colorectal surgery. The adhesion determination algorithm module performs adhesion warnings through the following process:

[0087] Level 1 warning (suspected adhesion): When the adhesion determination algorithm module detects that the strain value (i.e., the electrical signal) of a single micro strain sensor 1 is greater than 5% of the adhesion strain threshold for 1 hour, the external wireless monitoring terminal displays a "yellow warning". The adhesion determination algorithm module controls the micro buzzer to provide a low-frequency prompt with a volume ≤35dB, which will not affect the patient's rest; the normal postoperative tissue activity strain value is ≤3%.

[0088] Level 2 warning (mild adhesion): When the adhesion determination algorithm module detects that the strain values ​​of at least two micro strain sensors 1 are greater than 8% of the adhesion strain threshold for 2 hours, the external wireless monitoring terminal displays an "orange warning". The adhesion determination algorithm module controls the micro buzzer to provide a mid-frequency prompt with a volume range of 60-70dB. At the same time, the warning information is pushed to the patient's family's mobile APP via Bluetooth module.

[0089] Level 3 Warning (Moderate Adhesion): When the adhesion determination algorithm module detects that the strain values ​​of at least three micro-strain sensors 1 are greater than 12% of the adhesion strain threshold for 1 hour, it indicates that the adhesion has affected tissue activity. The external wireless monitoring terminal displays a "red warning", and the adhesion determination algorithm module controls a micro-buzzer to provide a high-frequency prompt with a volume range of 90-100dB. At the same time, it sends an emergency alarm to the medical management platform via Bluetooth.

[0090] The external wireless monitoring terminal automatically stores strain data over 14 days, with a sampling frequency of once per minute, and then generates a strain trend graph. The horizontal axis of the strain trend graph represents time, and the vertical axis represents the strain value. Medical staff can export the data from the external wireless monitoring terminal via Bluetooth and then analyze the time points when adhesions occur based on the exported data. For example, a sudden increase in the strain value 5 days after surgery indicates that adhesions have begun to form.

[0091] The external wireless monitoring terminal supports "manual symptom recording": if a patient experiences discomfort such as abdominal pain or bloating, they can press a button on the terminal to record the time when the symptoms occur. The system will automatically associate the corresponding time point with the stress data to help medical staff determine the correlation between the symptoms and adhesions.

[0092] The healthcare management platform is built on the Hospital Information System (HIS) and supports access via computer (doctor's workstation) and mobile app (nurse's app). Its core functions include:

[0093] (1) Patient Monitoring List: Displays information on all patients wearing devices after surgery, such as name, hospital number, surgery time, and current alert level. Patients with red alerts are displayed at the top for priority handling by medical staff.

[0094] (2) Real-time data viewing: Click on the patient to view real-time strain data, strain trend graph and symptom record. If abnormal strain values ​​are found, such as a sudden increase in a short period of time, "position adjustment suggestions" can be sent remotely, such as "left lateral decubitus position for 30 minutes to relieve tissue traction".

[0095] (3) Intervention Recommendation: The medical management platform has a built-in "Guideline for Intervention of Abdominal Adhesions", which automatically recommends a plan based on the warning level. The first-level warning intervention plan is close observation + abdominal hot compress; the second-level warning intervention plan is gastrointestinal decompression + anti-adhesion drugs, such as pentoxifylline; the third-level warning intervention plan is to assess whether laparoscopic exploration is needed, and record the intervention measures and effects to form a closed loop of diagnosis and treatment.

[0096] (4) Data security: All monitoring data is transmitted in encrypted form, in compliance with the "Medical Data Security Management Standard", and stored in association with the patient's electronic medical record. The data retention period is ≥5 years, and it supports medical quality analysis such as postoperative adhesion incidence statistics and surgical effect evaluation.

[0097] In this embodiment, the membrane of the anti-colonic adhesion monitoring patch is a rectangular sheet, and its size can be customized to, for example, 5cm×8cm or 10cm×15cm, with a thickness of 0.15mm. The thickness of the anti-adhesion layer a, the monitoring layer b, and the support layer c is 50μm.

[0098] The micro-strain sensor array 1 is used to collect deformation signals of the membrane; in this embodiment, the array density of the micro-strain sensor array 1 is 5 micro-strain sensors 1 / ,like Figure 1 As shown, the diameter of a single micro strain sensor 11 is 50 μm and the thickness is 20 μm; the sensitivity of the micro strain sensor 1 is ≥0.1% strain.

[0099] The micro strain sensor 1 is a biodegradable flexible micro strain sensor, and its core parameters are as follows:

[0100] The dimensions of the sensing element are 50μm long × 50μm wide × 20μm thick;

[0101] The sensitive area of ​​a single miniature strain sensor 1 is 0.01. (0.1mm × 0.1mm square), this size design is based on the local characteristics of abdominal adhesions—early adhesions are mostly punctate or small-area fibrin connections, typically ≤1mm in diameter, 0.01 The sensitive area can precisely capture minute local deformations. When a certain area on the membrane... When adhesion occurs in a 10mm × 10mm area, the five sensors distributed within that area can each monitor 0.01. Strain in sensitive areas is assessed by fusing multi-point data to determine the overall deformation trend, such as 1. All three sensors in the area detected strain ≥8%, indicating moderate adhesion in the area.

[0102] The strain measurement range of a single miniature strain sensor 1 is 0-20%, which covers the entire scenario of membrane deformation caused by abdominal adhesions. The specific correspondence is as follows:

[0103] 0-3% strain: Slight deformation of the membrane caused by normal physiological activities such as intestinal peristalsis and respiratory movements, with no risk of adhesion;

[0104] 3%-8% strain: Early fibrinous adhesions, adhesion area ≤0.5 Minor deformation caused by local tissue traction;

[0105] 8%-15% strain: moderate fibrous adhesion, adhesion area 0.5-1 The contraction of fibrous tissue leads to significant traction on the membrane;

[0106] 15%-20% strain: severe adhesion, adhesion area > 1 Or, if the adhesions are under great tension, such as the continuous traction caused by adhesions between the intestine and the peritoneum, the membrane may rupture if it is close to its maximum tolerance deformation and exceeds 20%. However, in clinical practice, the deformation of severe adhesions rarely exceeds 18%.

[0107] Locality and Conductivity of Abdominal Adhesions: In the initial stage of abdominal adhesions, fibrinous adhesions often appear as punctate or small patchy connections, 0.1-0.5 mm in diameter. However, the tensile tension generated by the adhesions is conducted to the surrounding area through the membrane, similar to the deformation diffusion of a thin film under stress. For example, an adhesion point with a diameter of 0.2 mm can induce a deformation area with a diameter of 1-2 mm on the membrane, with the strain value decreasing from the center to the edge. (Single sensor 0.01) Although the sensitive area is small, indirect monitoring can be achieved by capturing the signal of the "deformation conduction zone" - even if the adhesion point does not directly cover the sensor, the deformation within 1 mm around it can still be sensed by the sensor, and the strain value is ≥3%.

[0108] 1 Actual coverage efficiency of the 5 sensors: 5 sensors in 1 The internal structure is distributed in an equilateral triangular grid with an adjacent spacing of approximately 0.47 mm. The effective monitoring radius of a single sensor, i.e., the range of deformation it can detect, is 0.5 mm. This was verified through membrane mechanical simulation. Therefore:

[0109] The effective monitoring area of ​​a single sensor is approximately π×(0.5mm)²≈0.785. ;

[0110] The total effective monitoring area of ​​the 5 sensors is approximately 5 × 0.785. =3.925 After overlay coverage, the actual area without blind spots accounts for ≥90%, with only very small edge areas possibly overlapping or missing.

[0111] For adhesion points with a diameter ≥ 0.3 mm, their deformation conduction zone must cover the effective monitoring range of at least one sensor to ensure that the signal is captured.

[0112] The sensitivity, i.e., the strain coefficient GF, is 2.2 ± 0.2, ensuring that minute deformations can be captured;

[0113] The operating temperature range is 35-39℃, which is suitable for the human abdominal cavity environment;

[0114] With a response time of ≤10ms, it can track the dynamic changes of adhesion and traction in real time.

[0115] The micro strain sensor 1 adopts a three-layer composite structure of "substrate-sensitive layer-electrode", and all components are made of biodegradable materials.

[0116] The substrate material is a polylactic acid (PLA) film with a molecular weight of 50 kDa and a thickness of 10 μm, prepared by solution casting. It exhibits good flexibility and mechanical stability, with a bending radius ≤1 mm and a tensile strength ≥50 MPa. The substrate material shows a degradation rate ≥90% in simulated body fluid at 37°C for 14 days, with the degradation product being lactic acid, which can be metabolized through the tricarboxylic acid cycle.

[0117] The sensitive layer material is a magnesium-zinc-calcium alloy (Mg-Zn-Ca93:5:2) nanowire network with a diameter ranging from 50-100 nm and a length ranging from 5-10 μm. This nanowire network is uniformly distributed on the PLA substrate surface by electrodeposition, forming a conductive path. When the film is subjected to tensile deformation, the change in nanowire spacing leads to a change in resistance. The resistance change rate is ≥6% when the strain value is 3%, realizing the conversion of strain signal into electrical signal.

[0118] The electrode material is a 5 μm thick magnesium-silver alloy (Mg-Ag90:10) thin film, prepared at both ends of the sensitive layer by magnetron sputtering, serving as the signal output terminals. The addition of silver to the electrode material reduces the electrode contact resistance to ≤5Ω, while the dominant magnesium component ensures biodegradability, with a degradation rate of ≥85% after 14 days.

[0119] The encapsulation layer material is a hyaluronic acid (HA) hydrogel coating with a molecular weight of 300 kDa and a thickness of 3 μm. It is cured with a 0.5% concentration of crosslinking agent genipin to achieve waterproofing and resistance to body fluid corrosion. It can withstand immersion for ≥10 days without affecting the flexibility and strain transmission of the sensor.

[0120] The biodegradable flexible antenna used for signal transmission in monitoring layer b adopts a "substrate-radiator-protective layer" structure, and the material selection and performance adaptation are as follows:

[0121] The substrate material is a polycaprolactone (PCL) film with a molecular weight of 80 kDa and a thickness of 20 μm. It is prepared by melt extrusion and has excellent flexibility and fatigue resistance. It can be repeatedly bent to a radius of 5 mm without breaking, and its mechanical properties are retained at ≥90% after 1000 bends. The degradation cycle is 14 ± 2 days, which is synchronized with the overall degradation of the film.

[0122] The radiator material is a magnesium-lithium alloy (Mg-Li97:3) foil with a thickness of 1 μm. It is fabricated into a zigzag dipole antenna structure using photolithography, with a length of 15 mm and a width of 0.5 mm. The conductivity is... S / m ensures a radiation efficiency of ≥40% in the 3.1-4.8GHz frequency band, i.e., the UWB communication frequency band, to meet the signal transmission requirements that penetrate the abdominal wall, with an abdominal wall thickness ranging from 2-5cm.

[0123] The protective layer material is a composite film made of gelatin and sodium alginate mixed in a mass ratio of 3:1, with a thickness of 5μm. The molecular weight of gelatin is 15kDa, and the molecular weight of sodium alginate is 200kDa. This composite film is applied to the surface of the radiator by casting. It has good biocompatibility and resistance to body fluid erosion, i.e., a cytotoxicity rating of ≤1. It does not dissolve in simulated peritoneal fluid for 10 days and does not affect the electromagnetic wave penetration of the antenna.

[0124] The biodegradable amplifier 21 in the signal conditioning circuit 2 is model BDA-02. Its core function is to amplify the mV-level analog signal output by the miniature strain sensor 1 by 20-40dB to meet the requirements of subsequent ADC conversion.

[0125] The material composition of the biodegradable amplifier 21 is as follows:

[0126] Substrate: Polylactic acid-polycaprolactone copolymer (PLA-PCL7:3) film with a thickness of 8μm, combining the rapid degradability of PLA with the flexibility of PCL;

[0127] Active component: Organic semiconductor material "poly(3-hexylthiophene)-fullerene derivative" (P3HT:PCBM), fabricated into a field-effect transistor (FET) by inkjet printing, with a channel length of 50μm and a mobility of ;

[0128] Electrode: Magnesium-zinc alloy (Mg-Zn95:5) nanowires, 30 nm in diameter, prepared by electrospinning, with conductivity of [missing information]. 1;

[0129] Encapsulation layer: Chitosan-gelatin composite film with a thickness of 2μm, and 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC) as the crosslinking agent to ensure resistance to body fluid erosion.

[0130] Degradation cycle control:

[0131] The PLA-PCL substrate undergoes gradual degradation through ester bond hydrolysis in simulated body fluid at 37°C. After 10 days, the mechanical properties are retained at ≥70%, ensuring stable amplification, and the degradation rate is ≥90% after 14 days.

[0132] The organic semiconductor material gradually dissolves as the substrate degrades, and is completely decomposed into small molecule organic matter within 14 days, leaving no toxic residue.

[0133] The biodegradable filter 22 in the signal conditioning circuit 2 is model BDF-01. Its core function is low-pass filtering with a cutoff frequency of 10Hz. It filters out high-frequency noise generated by intestinal peristalsis, where the high-frequency noise frequency is >10Hz.

[0134] The material composition of the biodegradable filter 22 is as follows:

[0135] Resistance: Magnesium-copper alloy (Mg-Cu98:2) thin film, 1μm thick, fabricated by magnetron sputtering, sheet resistance 50Ω, temperature coefficient ≤±500ppm / ℃;

[0136] Capacitor: The upper and lower electrodes are made of magnesium-silver alloy (Mg-Ag90:10), the dielectric layer is a biodegradable ceramic "magnesium phosphate" with a thickness of 500nm, the capacitance is 100pF, and the loss tangent is ≤0.05.

[0137] Substrate: Hyaluronic acid-sodium alginate composite film, 10μm thick, prepared by freeze drying, with a porosity of ≤5% to avoid the infiltration of body fluids that may affect capacitance performance.

[0138] Degradation cycle control:

[0139] Magnesium-based resistors / electrodes undergo oxidative corrosion in body fluids, maintaining stable resistance / capacitance values ​​with a deviation of ≤5% within 10 days, and rapidly degrading within 12-14 days with a corrosion rate ≥0.1μm / day;

[0140] The magnesium phosphate dielectric layer gradually hydrolyzes in body fluid at pH 7.4 to form... and , and It is an essential ion for the human body, with a degradation rate of ≥95% in 14 days.

[0141] The degradable ADC converter in signal conditioning circuit 2 is model BAD-12. Its core function is 12-bit analog-to-digital conversion, which converts the filtered analog signal into a digital signal with a sampling rate of 1Hz.

[0142] The material composition of the biodegradable ADC converter is as follows:

[0143] Core chip substrate: Polycaprolactone (PCL) nanofiber membrane with a molecular weight of 60 kDa and a thickness of 5 μm, prepared by electrospinning with a fiber diameter of 300 nm, used to provide flexible support;

[0144] The switching circuit uses an organic thin-film transistor (OTFT) array, with a channel material of polythiophene derivative and a gate insulating layer of biodegradable polyethylene glycol (PEG) with a molecular weight of 10 kDa, ensuring an on / off ratio ≥ ;

[0145] Lead wire: Magnesium-calcium alloy (Mg-Ca96:4) wire, 50μm in diameter, soldered to the electrode end, with a contact resistance ≤10Ω.

[0146] Degradation cycle control:

[0147] The PCL substrate maintains structural integrity with a degradation rate of ≤30% during the first 0-10 days post-surgery. Hydrolysis accelerates after 10 days, and the degradation rate is ≥90% after 14 days.

[0148] The PEG insulating layer has a solubility of ≥80% in body fluids within 12 days, ensuring the stability of the ADC function during the critical monitoring period (0-10 days) and its failure in sync with the substrate in the later stages.

[0149] The biodegradable main control chip is model BMC-03. Its core function is to run an adhesion determination algorithm and control the collaborative work of various modules.

[0150] The biodegradable main control chip is composed of the following materials:

[0151] Chip substrate: Polylactic acid (PLA) and silk fibroin composite film. PLA has a molecular weight of 40kDa and a thickness of 15μm. PLA provides biodegradability, while silk fibroin enhances mechanical strength. Tensile strength ≥30MPa.

[0152] The computing core is based on biodegradable organic logic gate circuits, consisting of 100 organic thin film transistors. It adopts a complementary logic structure, that is, a combination of P-type and N-type organic thin film transistors. The operating voltage is 3.3V, the main frequency is 1MHz, and the power consumption is ≤5μW.

[0153] Encapsulation: Polyethylene glycol-gelatin composite coating, 3μm thick, waterproof and does not affect signal transmission.

[0154] Degradation cycle control:

[0155] Silk protein remains stable within 10 days post-surgery, with an enzymatic hydrolysis rate of ≤20%. After 10 days, it is degraded by intraperitoneal proteases such as trypsin, leading to the disintegration of the PLA substrate.

[0156] Organic logic gate circuits completely fail within 14 days as the substrate degrades, and the degradation products are amino acids and lactic acid, which are non-toxic.

[0157] The biodegradable EEPROM model is BEM-01. Its core function is to store strain data within 14 days. It has a capacity of 8MB, a sampling rate of 1 time / minute, and supports data retention even when power is off.

[0158] The material composition of biodegradable EEPROM is as follows:

[0159] Storage cell: Biodegradable ferroelectric memory, the ferroelectric layer is a 200 nm thick barium magnesium titanate (BMT) film, prepared by the sol-gel method, with a remanent polarization ≥10 μC / ;

[0160] Electrode: Magnesium-tin alloy (Mg-Sn97:3), 1 μm thick, conductivity ≥5× S / m;

[0161] Substrate: Polybutylene adipate (PBA) film, molecular weight 30 kDa, thickness 10 μm, degradation rate slightly faster than PCL, ensuring data retention up to 14 days.

[0162] Degradation cycle control:

[0163] The PBA substrate exhibits a degradation rate of ≤40% in the first 0-12 days post-surgery, ensuring the structural stability of the storage unit. Rapid hydrolysis occurs in 12-14 days, with a degradation rate ≥90%.

[0164] The magnesium barium titanate ferroelectric layer gradually dissolves within 14 days. , , The concentrations were all below the human safety threshold, ensuring that the data was not lost during the monitoring period.

[0165] The UWB transmission module 4, model BUT-02, has the core function of wireless transmission in the 3.1-4.8GHz frequency band, sending data to an external terminal at a transmission rate of 250kbps.

[0166] The material composition of UWB transmission module 4 is as follows:

[0167] Transmitter chip: Made of the same material as the main control chip, PLA-silk protein substrate + organic semiconductor, integrating oscillator and modulator, with an output power of -30dBm;

[0168] Antenna: Magnesium-Li97:3 alloy (Mg-Li97:3) zigzag dipole antenna, with PCL thin film as the substrate;

[0169] Matching circuit: A biodegradable inductor ensures impedance matching, with an impedance of 50Ω. The biodegradable inductor core is made of magnesium-zinc ferrite, and the coil is made of magnesium wire. The capacitor is made of the same material as the filter capacitor 22.

[0170] Degradation cycle control:

[0171] The transmitter chip maintains an emission efficiency of ≥40% for 10 days and completely degrades along with the substrate within 14 days.

[0172] Magnesium-lithium alloy antennas have a corrosion rate of ≤20% within 10 days, ensuring signal strength, and a corrosion rate of ≥95% within 14 days, with no metal residue.

[0173] The biodegradable power supply module 5, model BPS-05, has the core function of providing a stable 3.3V voltage for 14 days of continuous power supply and has a capacity of 10μAh.

[0174] The biodegradable power supply module 5 is composed of the following materials:

[0175] Anode: High-purity magnesium foil, 99.9% Mg, 50 μm thick, used as a sacrificial anode for the oxidation reaction, expressed as follows: ;

[0176] Cathode: Activated carbon-polypyrrole composite membrane, 30 μm thick, catalyzes oxygen reduction, chemical formula is: ;

[0177] Electrolyte: Polyethylene glycol PEG-sodium alginate hydrogel containing 0.1 mol / L NaCl to ensure ionic conductivity, with a conductivity ≥10 mS / cm;

[0178] Outer shell: chitosan membrane, 10μm thick, to prevent excessive contact between body fluids and electrodes.

[0179] Degradation cycle control:

[0180] The magnesium anode is designed with a thickness precisely matched to the 14-day discharge requirement, consuming an average of 3.5μm per day, and is completely oxidized within 14 days. The concentration is ≤0.1mmol / L, and it is safe and non-toxic.

[0181] The chitosan shell remains intact for 10 days with a degradation rate of ≤30%. It dissolves after 10 days, accelerating the reaction between the electrolyte and the electrode, and ensuring that the charge is depleted and completely degraded within 14 days.

[0182] Each component completes its degradation through a degradation cycle collaborative control mechanism, which is as follows:

[0183] Each component undergoes a triple regulation process involving material ratio, structural design, and environmental response to ensure simultaneous degradation within approximately 14 days.

[0184] Material degradation rate gradient: Select degradable materials with different degradation rates according to functional requirements. Modules that require long-term stability, such as the main control chip and sensors, use PLA-PCL copolymer, which degrades more slowly. Auxiliary modules, such as filter 22 and antenna, use pure PLA or PBA, which degrades more quickly. The degradation cycle can be finely adjusted by the ratio of PLA to PCL through material formulation.

[0185] Structural protection design: Core circuits such as ADC and EEPROM are covered with a thin layer of highly cross-linked encapsulation film, such as chitosan-EDC cross-linked film, to delay the penetration of body fluids and ensure functional stability for the first 10 days; edge modules such as leads and antennas have reduced encapsulation to accelerate later degradation.

[0186] In vivo environmental response: By utilizing the stable conditions of intraperitoneal pH (7.2-7.4), temperature (37℃), and enzymes such as proteases and esterases, the hydrolysis / enzymatic hydrolysis rate of degradable materials such as polyesters and natural polysaccharides can be controlled. Through in vitro accelerated experiments, using a buffer solution at 37℃ and pH 7.4 + trypsin, the degradation rate of each module in the entire patch was ≥90% after 14 days, and the degradation products met the ISO10993 biosafety standard.

[0187] Furthermore, the biodegradable encapsulation membrane completely encapsulates the entire monitoring circuit D, including the micro-strain sensor array 1, signal conditioning circuit 2, main control unit 3, transmission module 4, and power supply module 5, forming a physical barrier to isolate the circuit from the penetration and erosion of intra-abdominal fluids such as ascites and tissue fluid. Simultaneously, its biodegradable properties must be precisely matched with the monitoring cycle and the overall degradation rate of the membrane. The following are supplementary technical details:

[0188] I. Encapsulation Scope and Structural Design of Biodegradable Encapsulation Films

[0189] The biodegradable encapsulation film, namely the hyaluronic acid-gelatin composite film, adopts a full-wrap encapsulation method to completely cover all circuit components of monitoring layer b. The specific design is as follows:

[0190] Packaging range: Extending outward from the edge of the micro strain sensor array 1 by 0.5mm to form a complete sealed boundary, ensuring that all conductive components of the circuit, such as electrodes, wires, and chip pins, do not directly contact the body fluid. The overall thickness of the packaging film is controlled between 5-8μm, with the thickness of the packaging film in the core circuit area, such as the main control chip and ADC converter, increased to 8μm to enhance protection, while the thickness in the edge lead area is reduced to 5μm to avoid affecting the flexibility of the film.

[0191] Layered packaging logic: Employs a three-layer coating process: bottom layer - middle layer - top layer.

[0192] Bottom layer: First, a 1-2μm hyaluronic acid solution with a molecular weight of 300kDa is coated, and then cross-linked and cured by genipin to fill the gaps between circuit components, such as the welding points between sensors and wires, forming a preliminary seal;

[0193] Middle layer: Coated with a 3-4μm hyaluronic acid-gelatin mixture at a mass ratio of 1:4, covering the bottom layer and encapsulating the entire circuit. It is lightly cross-linked with 0.1% glutaraldehyde by volume to improve the swelling resistance of the membrane.

[0194] Top layer: Coated with 1-2μm gelatin solution, molecular weight 15kDa, to form a smooth surface, reduce friction with abdominal tissues, and further block the penetration of body fluids.

[0195] II. Core Mechanisms of Isolation from Fluid Penetration and Erosion

[0196] The encapsulation film provides dual protection through material properties and structural design, ensuring that the monitoring circuit D is not affected by body fluids during the peak period of adhesion within 10 days.

[0197] The material's resistance to swelling and barrier properties:

[0198] After cross-linking, the molecular chains of the hyaluronic acid-gelatin composite film form a three-dimensional network structure. The swelling rate in body fluid (37℃, pH7.4) is ≤20% (24 hours), which is much lower than that of uncross-linked materials (swelling rate >100%), thus avoiding membrane rupture due to excessive swelling.

[0199] Water vapor permeability of the membrane ≤5g / • Liquid permeability ≤ 0.1 mL / 24h • 24h, tested according to ASTM E96 standard, effectively blocks water molecules and electrolytes in body fluids, such as... , Proteases, such as trypsin, penetrate the circuit surface to prevent the oxidation of metal electrodes, such as the corrosion of magnesium alloy wires, and the degradation of organic semiconductor materials, such as the dissolution of P3HT:PCBM.

[0200] Targeted protection of vulnerable areas:

[0201] For high-risk points in the circuit, such as wire solder joints and chip pins, the encapsulation film forms a locally thickened protrusion in this area with a thickness of 10μm, and adds 0.5% by mass of nano-montmorillonite particles with a diameter of 50nm. The layered structure of the nanoparticles further blocks the penetration path of body fluids.

[0202] The edges of the encapsulation film are designed with a rounded transition with a radius of 0.2mm to avoid cracking caused by stress concentration at right-angled edges. At the same time, the cross-linking degree of the edge area is increased to 60% and that of the core area to 40%, which enhances fatigue resistance and can withstand repeated stretching under 10% deformation of the film.

[0203] The degradation cycle of the anti-colonic adhesion monitoring patch is precisely controlled as follows:

[0204] (1) The degradation cycle of the anti-colonic adhesion monitoring patch is 14±2 days. From the time of implantation, it is completely degraded into harmless products and absorbed by the human body in about 14 days. The degradation process is "gradual", as follows:

[0205] Postoperative 0-7 days: The anti-adhesion layer a, monitoring layer b, and support layer c of each layer of the patch only undergo slight hydrolysis / enzymatic degradation, with a degradation rate of ≤20%, and the core structure and function remain intact. The anti-adhesion layer a can still physically block tissue contact and release anti-inflammatory factors. The circuits in the monitoring layer b, such as sensors, chips, and antennas, have stable performance, and there is no attenuation in signal transmission and data processing.

[0206] 7-10 days post-surgery: The material degradation rate accelerates, with a degradation rate of 30%-50%. However, key functional modules such as the micro strain sensor 1 and the main control chip still maintain their working capabilities. Only non-core areas such as the edge of the encapsulation film and the end of the lead wire show local degradation.

[0207] Postoperative days 10-14: Degradation enters the accelerated phase, with a degradation rate of 50%-90%. The monitoring layer b circuit gradually fails due to material disintegration, and the anti-adhesion layer a and support layer c disintegrate. Around 14 days, all materials are completely degraded, with a residual amount of ≤5%. Degradation products are excreted through metabolism or absorbed by tissues.

[0208] (2) The impact of early degradation on component function and the design to mitigate it are as follows:

[0209] The slow degradation process, which occurs 7-10 days after implantation, will not cause premature failure of core components. The key lies in the design of "degradation priority" and "functional module protection":

[0210] Degradation priority stratification:

[0211] Non-core structures such as the edge of the encapsulation film and the redundant fibers of the support layer are preferentially degraded, with a degradation rate of ≥40% in 7-10 days, but without affecting the overall function.

[0212] The core functional components include a micro strain sensor 1 sensitive layer, a main control chip computing unit, and a UWB transmission module 4 transmitter. Degradation is delayed through material selection and structural reinforcement. For example, the sensor sensitive layer is encapsulated with highly cross-linked hyaluronic acid, and the degradation rate is ≤10% within 7-10 days, ensuring the accuracy of strain signal acquisition.

[0213] Component failure threshold control:

[0214] Set the "critical degradation rate for functional failure": For example, the metal nanowire network of the micro strain sensor 1 needs to maintain ≥80% conductivity to work normally, which corresponds to a degradation rate ≤20%. Through in vitro experiments, this state can be maintained until 10 days after the operation.

[0215] When the degradation rate of the organic transistor array in the main control chip is ≤30%, the on / off ratio is still ≥ within 10 days after the operation. This meets the requirements for algorithm operation;

[0216] Redundancy design compensation:

[0217] The miniature strain sensor array 1 uses "5 / The dense distribution of sensors ensures that even if some sensors fail due to local degradation (with a failure rate of ≤10% within 7-10 days), the remaining sensors can still cover the monitoring area, guaranteeing the integrity of signal acquisition.

[0218] (3) Precise matching mechanism between the effective period of component degradation and the period of high incidence of adhesion

[0219] The peak period for adhesions is 3-10 days post-surgery. Each component is matched through a dual-dimensional design that considers both material properties and functional lifespan.

[0220] Material degradation rate and peak time period:

[0221] The core components of monitoring layer b: "PLA-PCL copolymer (7:3)" is used as the substrate. In body fluid at 37℃, the degradation rate of this material is ≤30% in the first 10 days, the ester bond hydrolysis rate is 0.02μm / day, and the degradation rate increases rapidly after 10 days - ensuring that the electrical performance of the sensor, chip and transmission module 4 decreases by ≤10% within 3-10 days after surgery, meeting the monitoring requirements;

[0222] Anti-adhesion layer a: Hyaluronic acid-chitosan hydrogel has a degradation rate of ≤20% in the first 7 days, with stable physical barrier and anti-inflammatory factor release functions. The degradation rate increases to 50% in 7-10 days, at which point the tissue has passed the high-risk period of adhesion. It is completely degraded after 10 days.

[0223] Coordination between functional failure points and peak periods:

[0224] The "functional failure point" of the components is set to 10-12 days after the operation, after the risk of adhesion is significantly reduced: for example, the antenna of UWB transmission module 4 has a corrosion rate of ≥30% after 10 days after the operation, and the signal strength is attenuated to -25dB. It can still transmit but the efficiency is reduced. It completely fails after 12 days, and at this time there is no need for monitoring.

[0225] The results of in vitro accelerated experiments (37℃, pH 7.4 buffer + trypsin) verified that all components met clinical requirements within 10 days post-surgery, and the failure after 10 days was completely synchronized with the end of the high-incidence period of adhesions (10 days).

[0226] The following measures ensure the safety of tissue healing during the later stages of component degradation:

[0227] The subsequent degradation process of components after their failure period (10 days) will not interfere with tissue healing, which is achieved through the following design:

[0228] Biocompatibility of degradation products:

[0229] The end products of all biodegradable materials are substances that are metabolically acceptable to the human body: metal alloys (magnesium-zinc, magnesium-lithium) degrade into... , Essential trace elements for the human body, concentration ≤0.1mmol / L; polymers PLA and PCL degrade into lactic acid, which is then metabolized through the tricarboxylic acid cycle. 2 and Natural polysaccharides such as hyaluronic acid and gelatin degrade into glucuronic acid and amino acids, which participate in tissue repair.

[0230] ISO10993 biosafety testing verified that the degradation products have no cytotoxicity (rating ≤1), no hemolytic reaction (hemolysis rate <5%), and no immunogenicity (did not induce excessive macrophage aggregation).

[0231] Degradation rate and tissue healing time are matched:

[0232] The critical period for tissue healing of the colorectal anastomosis is 7-10 days postoperatively, during which fibrous tissue proliferation and vascular reconstruction are completed. After 10 days, the remodeling period begins, and the tensile strength gradually increases.

[0233] The material disintegration rate in the later stage of component degradation, i.e., 10-14 days, matches the tissue remodeling period: at this time, the degradation products are released slowly, with an average daily release of ≤0.05mmol / L, which will not cause local osmotic pressure abnormalities or inflammatory reactions, and the size of degradation fragments is ≤50μm, which can be phagocytosed and cleared by macrophages, avoiding the formation of foreign body granulomas.

[0234] No residue design:

[0235] By controlling the molecular weight of materials, such as PLA with a molecular weight of 50kDa and PCL with a molecular weight of 60kDa, we ensure complete degradation within 14 days, with a residual amount of ≤5%, and that residual fragments are completely absorbed within 21 days after surgery, without affecting the long-term healing of tissues such as the tensile strength of the anastomosis.

[0236] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A monitoring patch for preventing colorectal adhesions, characterized in that: The membrane structure is a tightly connected three-layer membrane, consisting of an anti-adhesion layer (a), a monitoring layer (b), and a support layer (c) from the outside to the inside. The anti-adhesion layer (a) and the support layer (c) are the same size, while the monitoring layer (b) is smaller than the anti-adhesion layer (a) and the support layer (c). The anti-adhesion layer (a) and the support layer (c) are bonded together around their perimeter, completely sandwiching the monitoring layer (b) between them. The monitoring layer (b) is integrated with a monitoring circuit (D), which is equipped with a micro strain sensor (1) array, a signal conditioning circuit (2), a main control unit (3) and a transmission module (4). The array of micro strain sensors (1) is provided with m micro strain sensors (1) arranged in an array. The output terminals of all micro strain sensors (1) are connected to the input terminal of the signal conditioning circuit (2). The output terminal of the signal conditioning circuit (2) is connected to the input terminal of the main control unit (3). The output terminal of the main control unit (3) is connected to the input terminal of the transmission module (4). The output terminal of the transmission module (4) is provided with a degradable flexible antenna.

2. The anti-colonic adhesion monitoring patch according to claim 1, characterized in that: The anti-adhesion layer (a) is a hyaluronic acid-chitosan composite hydrogel, on which anti-inflammatory factors are attached.

3. The anti-colonic adhesion monitoring patch according to claim 1, characterized in that: The monitoring layer (b) is a biodegradable encapsulation film, on which a monitoring circuit (D) is integrated. The biodegradable encapsulation film is a hyaluronic acid-gelatin composite film, which adopts a full-wrap encapsulation method to completely cover the monitoring circuit (D).

4. The anti-colonic adhesion monitoring patch according to claim 3, characterized in that: The monitoring circuit (D) is also provided with a power supply module (5) and a storage module (31), which are respectively connected to the control unit; Each module of the monitoring circuit (D) is made of biodegradable material, and the modules are connected by biodegradable wires.

5. The anti-colonic adhesion monitoring patch according to claim 4, characterized in that: The strain measurement range of a single micro-strain sensor (1) is 0-20%, which covers the entire scenario of membrane deformation caused by abdominal adhesions. The specific correspondence is as follows: 0-3% strain: Slight deformation of the membrane caused by normal physiological activities such as intestinal peristalsis and respiratory movements, with no risk of adhesion; 3%-8% strain: Early fibrinous adhesions, adhesion area ≤0.5 Minor deformation caused by local tissue traction; 8%-15% strain: moderate fibrous adhesion, adhesion area 0.5-1 The contraction of fibrous tissue leads to significant traction on the membrane; 15%-20% strain: severe adhesion, adhesion area > 1 Or, the adhesions may have high traction tension, such as the continuous traction caused by adhesions between the intestine and the peritoneum, causing the membrane to approach its maximum tolerance deformation.

6. The anti-colonic adhesion monitoring patch according to claim 1, characterized in that: The support layer (c) is a polycaprolactone nanofiber membrane, the outer surface of which is covered with a medical bio-adhesive coating.

7. The anti-colonic adhesion monitoring patch according to claim 1, characterized in that: The degradation cycle of the anti-colorectal adhesion monitoring patch is 14±2 days. From the time of implantation, it is completely degraded into harmless products and absorbed by the human body in about 14 days. The degradation process is as follows: Postoperative days 0-7: The anti-adhesion layer (a), monitoring layer (b), and support layer (c) of each layer of the patch only undergo slight hydrolysis / enzymatic degradation, with a degradation rate of ≤20%, and the core structure and function remain intact. The anti-adhesion layer (a) can still physically block tissue contact and release anti-inflammatory factors, and the monitoring layer (b) has stable circuit performance with no attenuation in signal transmission and data processing. 7-10 days after surgery: The material degradation rate accelerates, with a degradation rate of 30%-50%, but key functional modules such as micro strain sensor (1) and main control unit (3) still maintain their working ability. Only the edge and non-core areas, such as the edge of the encapsulation film and the end of the lead wire, show local degradation. Postoperative days 10-14: Degradation enters the accelerated phase, with a degradation rate of 50%-90%. The monitoring layer (b) circuit gradually fails due to material disintegration. The anti-adhesion layer (a) and support layer (c) structure disintegrate. All materials are completely degraded in about 14 days, with a residual amount of ≤5%. Degradation products are excreted through metabolism or absorbed by tissues.

8. A monitoring system based on the anti-colonic adhesion monitoring patch according to any one of claims 1 to 7, characterized in that: It includes an anti-colonic adhesion monitoring patch and an external wireless monitoring terminal that is connected to the anti-colonic adhesion monitoring patch via wireless communication. The monitoring layer (b) of the anti-colonic adhesion monitoring patch is integrated with a monitoring circuit (D), which is provided with a micro strain sensor (1) array, a signal conditioning circuit (2), a main control unit (3) and a transmission module (4). The array of micro-strain sensors (1) is used to acquire strain signals of the membrane; The signal conditioning circuit (2) is provided with an amplifier (21), a filter (22) and an analog-to-digital converter (23) connected in sequence. The signal conditioning circuit (2) is used to amplify, filter and convert the strain signal in sequence to obtain an electrical signal and transmit it to the main control unit (3). The main control unit (3) is used to send the electrical signal to the external wireless monitoring terminal through the transmission module (4); The external wireless monitoring terminal is used to monitor the abdominal adhesion status of the target person in real time based on the electrical signal, and to issue an early warning when abdominal adhesion is detected in the target person.

9. The monitoring system according to claim 8, characterized in that: The external wireless monitoring terminal is a portable waist-mounted monitoring terminal, which is used by patients to hang on their waist after surgery and establish wireless communication with the monitoring layer (b) of the internal anti-colonic adhesion monitoring patch. The external wireless monitoring terminal integrates an adhesion determination algorithm module, which is connected to an LCD display, a miniature buzzer, and a Bluetooth module. The LCD screen is used to display patient information and monitoring data; The miniature buzzer is used for adhesion alarm; The Bluetooth module is used to acquire the electrical signal and send warning information to the patient's family's mobile APP or the medical staff management platform.

10. The monitoring system according to claim 9, characterized in that: The adhesion determination algorithm module provides adhesion warnings through the following process: Level 1 warning: When the adhesion determination algorithm module detects that the strain value of a single micro strain sensor (1), i.e. the electrical signal, is greater than 5% of the adhesion strain threshold for 1 hour, the external wireless monitoring terminal displays a "yellow warning", and the adhesion determination algorithm module controls the micro buzzer to provide a low-frequency prompt with a prompt volume ≤35dB; Level 2 warning: When the adhesion determination algorithm module detects that the strain values ​​of at least two micro strain sensors (1) are greater than 8% of the adhesion strain threshold for 2 hours, the external wireless monitoring terminal displays an "orange warning", the adhesion determination algorithm module controls the micro buzzer to provide a mid-frequency prompt, and pushes the warning information to the patient's family's mobile APP via Bluetooth module. Level 3 warning: When the adhesion determination algorithm module detects that the strain value of at least three micro strain sensors (1) is greater than 12% of the adhesion strain threshold for 1 hour, the external wireless monitoring terminal displays "red warning", the adhesion determination algorithm module controls the micro buzzer to provide high-frequency prompts, and at the same time sends an emergency alarm to the medical care management platform via Bluetooth module.

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