Rectal postoperative anastomotic stoma protection device and use method

Abstract

The embodiment of the invention provides a rectal postoperative anastomotic stoma protection device and a use method, and relates to the technical field of intestinal postoperative anastomotic stoma protection technologies. The device comprises an attaching piece used for being attached to external tissue, a fixing piece used for being fixedly connected with the attaching piece and fixing the attaching piece, and a bag detachably connected with the attaching piece and used for receiving excrement from the attaching piece. According to the invention, the problem of high infection risk is solved, so that the effect of reducing the infection risk is achieved.

Description

Technical Field

[0001] The present invention relates to the field of anastomotic protection after intestinal surgery, and more specifically, to a device and method for protecting anastomotic sites after rectal surgery. Background Technology

[0002] Anastomotic leakage after intestinal surgery is the most serious and common complication after colorectal surgery, often requiring colostomy and fecal diversion. After intestinal surgery, finding safe and effective methods to isolate the anastomosis from feces is a hot research topic for reducing anastomotic leakage and promoting intestinal recovery.

[0003] Existing anastomotic protection devices cannot effectively isolate feces from the anastomosis, resulting in a high risk of infection. There is also a lack of solutions for real-time monitoring of anastomotic inflammation and early signs of fistula. Summary of the Invention

[0004] This invention provides a device and method for protecting the anastomosis site after rectal surgery, which at least solves the problem of high infection risk caused by the inability to effectively isolate feces from the anastomosis site in related technologies.

[0005] According to one embodiment of the present invention, a device for protecting anastomotic sites after rectal surgery is provided, comprising:

[0006] Adhesive components are used to adhere to external tissues.

[0007] A fastener is fixedly connected to the fitting component for fixing;

[0008] The bag, detachably connected to the fitting, is used to receive feces from the fitting.

[0009] In one exemplary embodiment, the fastener is configured as an inflatable component, the fastener is connected to an inflatable tube, the inflatable tube passes through the fitting component, and the inflatable tube is provided with a valve.

[0010] In one exemplary embodiment, the fastener includes a connector, and the end of the connector away from the fitting member has a guide opening, the diameter of which is larger than the diameter of the connector.

[0011] In one exemplary embodiment, the diameter of the end of the connector near the adhesive member is greater than the diameter of the connector, and the end of the connector near the adhesive member is fixedly connected to the adhesive member.

[0012] In one exemplary embodiment, the maximum diameter of the fitting is greater than the diameter of the connector.

[0013] In one exemplary embodiment, the end of the fitting member away from the fixing member is provided with an expansion slot, and the fitting member is detachably connected to the pouch through the expansion slot.

[0014] In one exemplary embodiment, the expansion slot includes a mounting member, one end of which is fixedly connected to the fitting member, and the other end of the mounting member near the fitting member is provided with a snap-fit ​​member, which is detachably connected to the pouch in conjunction with the mounting member.

[0015] In one exemplary embodiment, the bag opening is provided with a fitting member, and the snap-fit ​​member is detachably connected to the fitting member in conjunction with the mounting member.

[0016] In one exemplary embodiment, the diameter of the mounting member gradually increases along the direction of fecal movement.

[0017] According to another embodiment of the present invention, a method of using a postoperative anastomotic protection device for rectal surgery is provided, applied to the aforementioned postoperative anastomotic protection device for rectal surgery, comprising:

[0018] Acquire sensing data collected by a micro biosensor, wherein the micro biosensor is fixed to the outside of the adhesive component, and the sensing data includes at least temperature and humidity data, pH value data, and biomarker data;

[0019] The dynamic trend of the multidimensional indicators is determined based on the sensor data;

[0020] The dynamic trend is input into a preset early warning model, and the prediction result is determined by the early warning model.

[0021] An alarm is triggered if the prediction result meets the first condition; otherwise, a warning and tracking mechanism is activated.

[0022] By using this invention, the feces can be collected through the bag, preventing secondary contamination of the anastomosis by the feces. Therefore, the problem of infection caused by the inability to effectively isolate the anastomosis and feces can be solved, thereby reducing the risk of infection. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the overall structure of a postoperative anastomosis protection device for rectal surgery according to an embodiment of the present invention;

[0024] Figure 2 This is a structural cross-sectional view of a device for protecting anastomotic sites after rectal surgery according to an embodiment of the present invention;

[0025] Figure 3 yes Figure 2 Enlarged view of the structure at point A in the middle;

[0026] Figure 4 This is a flowchart illustrating a method of using a postoperative anastomotic protection device for rectal surgery according to an embodiment of the present invention.

[0027] In the diagram, 1 is the fitting part; 2 is the fixing part; 21 is the connecting part; 211 is the guide port; 3 is the bladder; 31 is the mating part; 32 is the adhesive part; 4 is the inflation tube; 5 is the expansion slot; 50 is the mounting part; and 51 is the snap-fit ​​part. Detailed Implementation

[0028] The technical solutions of the embodiments of this application will be described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments.

[0029] In the following description, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0030] Furthermore, in this application, directional terms such as "upper," "lower," "left," and "right" may be defined relative to the orientation of the components shown in the accompanying drawings. It should be understood that these directional terms can be relative concepts, used for relative description and clarification, and may change accordingly depending on the orientation of the components in the accompanying drawings.

[0031] In this application, unless otherwise expressly specified and limited, the term "connection" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral part; it can be a direct connection or an indirect connection through an intermediate medium. Furthermore, the term "coupled" can refer to an electrical connection that enables signal transmission.

[0032] As used herein, “about,” “approximately,” or “approximately” includes the stated value and the average value within an acceptable range of deviation from the given value, wherein the acceptable range of deviation is determined by a person skilled in the art taking into account the measurement under discussion and the error associated with the measurement of the given quantity (i.e., the limitations of the measurement system).

[0033] After intestinal cutting and suturing surgery (such as low rectal cancer anastomosis), the anastomosis generally needs to be protected to prevent fecal contamination and infection. The most common method for anastomotic protection is to create a protective enterostomy in the abdominal wall. This involves cutting the colon, pulling the colonic stump that connects to the esophagus and stomach to the abdominal wall, and fixing it there, forming a temporary enterostomy. After the rectal anastomosis heals, a second surgery is performed to reposition the intestine. However, this requires a second surgery, which can cause further harm to the patient. Therefore, some anastomotic protection devices are available on the market. These devices cannot be directly connected to the fecal bag used to collect feces, which could lead to leakage during defecation, affecting hygiene and nursing care.

[0034] Example 1

[0035] To solve the above problems, such as Figure 1-3 This embodiment provides a device for protecting the anastomosis site after rectal surgery, including an adhesive element 1 for adhering to external tissues (such as the intestinal wall, anal wall, etc.), a fixation element 2 fixed to the adhesive element 1 for fixing the entire device to the external tissue, and a pouch 3 detachably connected to the adhesive element 1 for receiving feces from the adhesive element 1. The pouch 3 is preferably a soft bag, such as a plastic bag or a rubber bag. The adhesive element 1 can be made of silicone material. In particular, the adhesive element 1 can be designed with a larger diameter at the proximal end and a gradually tapering structure at the distal end. At the same time, a softer and more deformable material can be used to better adapt to the external tissue anatomy of different patients and reduce discomfort.

[0036] To ensure that the adhesive patch 1 does not fall off and to facilitate its subsequent removal from external tissue, the fixing member 2 can be configured as an inflatable component, specifically a hollow cylindrical airbag. The end of the airbag away from the adhesive patch 1 has a guide port 211 to facilitate the flow of feces into the adhesive patch 1. The airbag is connected to the guide port 211 and the adhesive patch 1 via a connector 21. To enable local fixation after inflation, the airbag can be configured as a dumbbell shape, i.e., the diameter of the guide port 211 is larger than the diameter of the connector 21, and the diameter of the end of the connector 21 near the adhesive patch 1 is also larger than the diameter of the connector 21. The end of the connector 21 near the adhesive patch 1 is fixedly connected to the adhesive patch 1. In particular, the maximum diameter of the adhesive patch 1 can be greater than or equal to the diameter of the connector 21.

[0037] To inflate the airbag, an inflation tube 4 is connected to the airbag. The inflation tube 4 passes through the fitting 1. The inflation tube 4 is equipped with a valve, and an air injection port is provided at the end of the inflation tube away from the fixing member 2. After the valve is opened, air is inflated into the airbag through the air injection port. After the airbag is inflated, it fits against the inner wall of external tissues such as the intestines. At this time, the hollow part of the airbag forms a guiding channel, allowing feces to pass smoothly from the hollow part through the airbag and the fitting 1 until it falls into the bag 3.

[0038] To facilitate the connection between the bag 3 and the fitting 1, and to ensure proper collection of feces and prevent leakage, the fitting 1 has an expansion slot 5 at the end away from the fixing member 2. The expansion slot 5 supports external tissue and includes a mounting member 50. The end of the mounting member 50 near the fitting 1 is fixedly connected to the fitting 1. A locking member 51 is provided at the end of the mounting member 50 near the fitting 1. A mating member 31 is provided at the opening of the bag 3. The component 51 is detachably connected to the mounting component 50 and the mating component 31. Specifically, the snap-fit ​​component 51 can be set as a snap-fit ​​block, and the mating component 31 can be a rigid snap ring, such as a ring wire or a ring plastic buckle. In use, the mating component 31 at the bag opening is simply snapped into the snap-fit ​​block. Under the action of gravity, the snap-fit ​​block supports the mating component 31, thereby realizing the installation of the bag 3. Furthermore, a ring hook can be set on the mating component 31 to further snap and fix the snap-fit ​​component 51.

[0039] Specifically, to achieve installation stability, the diameter of the mounting component 50 gradually increases along the direction of fecal movement. At this time, its vertical cross-section is that the side circumference of the mounting component 50 is arc-shaped. Correspondingly, the mounting component 50 needs to have a certain elasticity to facilitate the installation of the bag 3. At the same time, an adhesive part is provided near the opening of the bag 3. The adhesive part is used to bond with external tissues, thereby further fixing the bag 3.

[0040] This application utilizes a balloon that can be fixed to the proximal end of the intestine with external sutures to drain feces, and uses a silicone channel (i.e., the fitting 1) to isolate feces from the anastomosis. At the same time, the silicone channel is fixed and connected to the balloon 3 through the anal dilation buckle 5, which can greatly reduce the risk of anastomotic leakage and the clinical stoma rate, avoid secondary surgery, and reduce user pain.

[0041] Specifically, the balloon is dumbbell-shaped and hollow, allowing stool to pass smoothly through its center after inflation. Before performing intestinal anastomosis, the surgeon inserts this component into the proximal intestinal segment, approximately 5 to 10 cm from the anastomosis site. Gas is injected through the valved inflator using a syringe, inflating the balloon to the preset level. Simultaneously, absorbable sutures are tied around the outside of the intestinal segment of the dumbbell-shaped balloon to secure its position and prevent movement. The knot should not be too tight to avoid intestinal ischemia and necrosis. After securing the balloon, all silicone channel portions are inserted into the proximal intestinal segment, and the anastomosis stapler is then inserted according to standard procedures to complete the intestinal anastomosis. After anastomosis, with the aid of a colonoscope, the silicone channel is guided out of the anus to prevent folding, and the anastomosis site can be checked for bleeding, leakage, etc. After anal dilation, an anal dilation chuck is used, and a silicone sleeve is inserted into the anus to maintain anal dilation and drain stool. Secure the bag by tightening the plastic ring at the opening into the anal dilation slot 5. Simultaneously, secure the silicone sleeve completely between the two slots to ensure proper drainage and storage of stool within the bag, preventing the silicone channel from retracting back into the anus. Finally, adhere the bag to the area around the anus to reduce tension on the intestinal tract. To remove the bag, use a syringe through the valved air inlet to extract the air from the balloon, then gently pull the silicone channel to remove it.

[0042] This embodiment provides a method for using a device for protecting the anastomosis site after rectal surgery. Figure 4 This is a flowchart illustrating a method of using a postoperative anastomotic protection device for rectal surgery according to an embodiment of the present invention. Figure 4 As shown, the process includes the following steps:

[0043] Step S11: Acquire sensing data collected by a micro biosensor, wherein the micro biosensor is fixed to the outside of the adhesive, and the sensing data includes at least temperature and humidity data, pH value data, and biomarker data.

[0044] In this embodiment, to further improve the observation of the anastomosis and reduce the impact of inflammation on the human body, one or more micro-sensor arrays are integrated on the outer wall of the silicone channel (adhesive), especially in the area corresponding to the anastomosis location. The micro-sensor arrays can be spirally embedded in three groups, each group spaced 120° apart, covering the entire circumference. The micro-sensors are connected to an MCU (such as an nRF52840) via a flexible printed circuit (FPC), with a uniform sampling frequency of 0.1Hz to balance power consumption and early anomaly detection. The micro-sensor types can include (but are not limited to) at least one of the following:

[0045] Temperature sensor: used to detect early fever in local infection / inflammation. This is because when infection or inflammation occurs at the anastomosis site, the temperature will rise abnormally. Continuous monitoring of temperature changes can serve as the earliest warning signal. An EMS temperature and humidity probe (±0.1℃ / ±2%RH) can be used in this case, specifically, the abnormal temperature appears earlier than the imaging.

[0046] pH sensor: used to detect intestinal fluid leakage caused by anastomotic leakage. When anastomotic leakage occurs, the leakage of intestinal fluid will cause a characteristic change in the pH value around the anastomosis. An IrOx microelectrode (±0.05pH) can be used here. When pH<6.5, a fistula is suspected.

[0047] Biomarker sensors: These are miniature biosensors that integrate the detection of specific inflammatory factors (such as CRP and procalcitonin) or bacterial metabolites, providing more specific diagnostic evidence for anastomotic leakage. Graphene FET antibody sensors and / or E. coli β-galactosidase sensors can be used here, exhibiting higher specificity than traditional blood tests.

[0048] Step S12: Determine the dynamic change trend of the multidimensional indicators based on the sensor data;

[0049] In this embodiment, during data processing, the spatial gradient (difference between adjacent sensors) of each array is first calculated based on the time series to enhance the abnormal signal at the anastomosis edge. Then, variational mode decomposition (VMD) is used to decompose the signal of each sensor into features such as low-frequency trend, mid-frequency abrupt change, and high-frequency noise. Subsequently, a joint feature is constructed based on temperature and pH value, specifically by calculating the ratio between the temperature difference and the pH value difference. When there is an anastomotic leakage, this ratio will exceed the threshold (e.g., >2.5℃ / pH unit), thereby enabling subsequent anomaly judgment. Similarly, dynamic trend features such as temperature baseline trend, temperature abrupt change amplitude, temperature spatial heterogeneity, pH baseline trend, and joint features are constructed.

[0050] Step S13: Input the dynamic change trend into the preset early warning model, and determine the prediction result through the early warning model;

[0051] In this embodiment, the prediction model is set to TinyML-LSTM (8-bit quantization). This model can detect abnormal trends in real time with a latency of <50ms. Before use, the model needs to be trained. The training data consists of monitoring data from 50 patients with anastomotic leakage and monitoring data from 200 patients who recovered normally (including continuous monitoring for 7 days after surgery). At the same time, GAN is used to generate minority class (fistula) samples to solve class imbalance. Bayesian optimization is used for model optimization.

[0052] Step S14: If the prediction result meets the first condition, an alarm is triggered; otherwise, early warning tracking is performed.

[0053] In this embodiment, an early warning model is used to predict multi-dimensional dynamic trends. When multiple multi-dimensional dynamic trends exceed preset thresholds, an anomaly is identified. For example, if the temperature change exceeds 0.3 degrees Celsius or the maximum CRP rise rate exceeds 0.5 mg / L / h, subclinical inflammation is considered, and a Level 1 warning is issued, which pushes the warning information to the doctor's app. When a single indicator is abnormal (e.g., CRP slope > 0.5 mg / L / h), a Level 2 warning is issued, and the monitoring frequency is increased to 1 Hz. When all indicators are within the threshold, a Level 3 warning is issued, and the data is simply stored in a time-series database, and so on.

[0054] Example 2

[0055] The difference from Embodiment 1 is that a miniature pressure sensor can also be set for the valve of the inflation port. This miniature pressure sensor can monitor the pressure inside the balloon in real time. At the same time, the miniature pressure sensor is connected to an external display device, and its pressure data is displayed through the external display device. This ensures that the balloon pressure is maintained within the optimal range that can effectively seal without compressing the intestinal wall and causing ischemia, and can promptly alarm when the balloon leaks air.

[0056] Through the above description of the embodiments, those skilled in the art can clearly understand that the methods according to the above embodiments can be implemented by means of software plus necessary general-purpose hardware platforms. Of course, they can also be implemented by hardware, but in many cases the former is a better implementation method. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk) and includes several instructions to cause a terminal device (which may be a mobile phone, computer, server, or network device, etc.) to execute the methods described in the various embodiments of the present invention.

[0057] This embodiment also provides a fecal diversion control system for postoperative anastomosis protection of the intestine. This system implements the above embodiments and preferred embodiments; details already described will not be repeated. As used below, the term "module" can refer to a combination of software and / or hardware that performs a predetermined function. Although the apparatus described in the following embodiments is preferably implemented in software, hardware implementation, or a combination of software and hardware, is also possible and contemplated.

[0058] Specifically, the system includes:

[0059] A data acquisition module is used to acquire sensing data collected by a micro biosensor, wherein the micro biosensor is fixed to the outside of the adhesive component, and the sensing data includes at least temperature and humidity data, pH value data, and biomarker data.

[0060] The trend calculation module is used to determine the dynamic change trend of multidimensional indicators based on the sensor data.

[0061] The prediction module is used to input the dynamic change trend into a preset early warning model and determine the prediction result through the early warning model;

[0062] An alarm module is used to issue an alarm if the prediction result meets a first condition, and otherwise to provide early warning and tracking.

[0063] It should be noted that the above modules can be implemented by software or hardware. For the latter, they can be implemented in the following ways, but are not limited to: all the above modules are located in the same processor; or, the above modules are located in different processors in any combination.

[0064] Embodiments of the present invention also provide a computer-readable storage medium storing a computer program, wherein the computer program is configured to perform the steps in any of the above method embodiments when executed.

[0065] In one exemplary embodiment, the aforementioned computer-readable storage medium may include, but is not limited to, various media capable of storing computer programs, such as a USB flash drive, read-only memory (ROM), random access memory (RAM), portable hard disk, magnetic disk, or optical disk.

[0066] Embodiments of the present invention also provide an electronic device including a memory and a processor, the memory storing a computer program and the processor being configured to run the computer program to perform the steps in any of the above method embodiments.

[0067] In one exemplary embodiment, the electronic device may further include a transmission device and an input / output device, wherein the transmission device is connected to the processor and the input / output device is connected to the processor.

[0068] Through the above description of the embodiments, those skilled in the art can clearly understand that, for the sake of convenience and brevity, only the division of the above functional modules is used as an example. In actual applications, the above functions can be assigned to different functional modules as needed, that is, the internal structure of the device can be divided into different functional modules to complete all or part of the functions described above.

[0069] In the several embodiments provided in this application, it should be understood that the disclosed apparatus and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of modules or units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another apparatus, or some features may be ignored or not executed. Furthermore, the mutual coupling or direct coupling or communication connection shown or discussed may be through some interfaces; the indirect coupling or communication connection between apparatuses or units may be electrical, mechanical, or other forms.

[0070] The units described as separate components may or may not be physically separate. A component shown as a unit can be one or more physical units; that is, it can be located in one place or distributed in multiple different locations. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0071] Furthermore, the functional units in the various embodiments of this application can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or as a software functional unit.

[0072] If the integrated unit is implemented as a software functional unit and sold or used as an independent product, it can be stored in a readable storage medium. Based on this understanding, the technical solutions of the embodiments of this application, in essence, or the parts that contribute to the prior art, or all or part of the technical solutions, can be embodied in the form of a software product. This software product is stored in a storage medium and includes several instructions to cause a device (which may be a microcontroller, chip, etc.) or processor to execute all or part of the steps of the methods of the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as USB flash drives, portable hard drives, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical disks.

[0073] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any changes or substitutions within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A device for protecting the anastomosis site after rectal surgery, characterized in that, include: Adhesive components are used to adhere to external tissues; A fastener is fixedly connected to the fitting component for fixing; The bag, detachably connected to the fitting, is used to receive feces from the fitting.

2. The apparatus according to claim 1, characterized in that, The fixing component is configured as an inflatable component, and the fixing component is connected to an inflation tube. The inflation tube passes through the fitting component and is equipped with a valve.

3. The apparatus according to claim 2, characterized in that, The fastener includes a connector, and the end of the connector away from the fitting member has a guide opening, the diameter of which is larger than the diameter of the connector.

4. The apparatus according to claim 3, characterized in that, The diameter of the end of the connector near the adhesive is greater than the diameter of the connector, and the end of the connector near the adhesive is fixedly connected to the adhesive.

5. The apparatus according to claim 3, characterized in that, The maximum diameter of the bonding component is greater than the diameter of the connecting component.

6. The apparatus according to claim 1, characterized in that, The end of the fitting component away from the fixing component is provided with an expansion slot, and the fitting component is detachably connected to the pouch through the expansion slot.

7. The apparatus according to claim 6, characterized in that, The expansion slot includes an installation component, one end of which is fixedly connected to the fitting component. The end of the installation component near the fitting component is provided with a snap-fit ​​component, which is detachably connected to the pouch in cooperation with the installation component.

8. The apparatus according to claim 7, characterized in that, The bag opening is provided with a fitting component, and the snap-fit ​​component is detachably connected to the fitting component in conjunction with the mounting component.

9. The apparatus according to claim 7, characterized in that, The diameter of the mounting component gradually increases along the direction of fecal movement.

10. A method of using a postoperative anastomotic protection device for rectal surgery, applied to the postoperative anastomotic protection device for rectal surgery as described in any one of claims 1-9, characterized in that, include: Acquire sensing data collected by a micro biosensor, wherein the micro biosensor is fixed to the outside of the adhesive component, and the sensing data includes at least temperature and humidity data, pH value data, and biomarker data; The dynamic trend of the multidimensional indicators is determined based on the sensor data; The dynamic trend is input into a preset early warning model, and the prediction result is determined by the early warning model. An alarm is triggered if the prediction result meets the first condition; otherwise, a warning and tracking mechanism is activated.

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