A double-layer braided surgical suture capable of indicating tension and a tension calibration method

Abstract

The application provides a double-layer braided surgical suture capable of indicating tension and a tension calibration method, and relates to the technical field of medical devices.The double-layer braided surgical suture comprises a suture body and at least one indicating segment; the suture body and the at least one indicating segment are sequentially connected along the length direction of the suture body; the indicating segment comprises a bearing layer located in an inner layer and a braided layer wrapped outside the bearing layer; the bearing layer is composed of medical fiber tows, and the braided layer is formed by braiding fibers with an initial braiding angle, a braiding density and a single-wire diameter; the bearing layer and the braided layer have a color difference; as the surgical suture is subjected to an increase in tension, the coverage of the braided layer on the bearing layer decreases. The application can reduce the cost of the surgical suture.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a tension-indicating double-layer braided surgical suture and a tension calibration method. Background Technology

[0002] Tension control during surgical suturing has always been a challenge in clinical surgery. In routine suturing or ligation procedures, surgeons primarily rely on their personal tactile and visual experience to assess suture tension. However, different surgeons have significantly different subjective perceptions of tension. Tactile feedback is a discrete signal that stops once a target is reached, making it difficult to provide continuous, progressive tension information. Therefore, in rapid procedures, it is easy for excessive instantaneous tension to occur, leading to complications such as tissue ischemia and suture breakage.

[0003] Existing technologies integrate conductive polymers or microelectronic sensors into sutures to monitor changes in resistance or electrical signals to reflect tension. However, such electronic sutures are expensive to manufacture, and the suture materials themselves are rigid and difficult to degrade, which greatly limits their widespread use in routine surgeries, especially minimally invasive laparoscopic surgeries. Summary of the Invention

[0004] This application is made in view of at least one of the above-mentioned technical problems existing in the prior art, and the application is able to reduce the cost of surgical sutures.

[0005] In a first aspect, embodiments of this application provide a double-layer braided surgical suture capable of indicating tension, comprising: a suture body and at least one indicator segment; Wherein, the suture body and the at least one indicator segment are sequentially connected along the length direction of the suture body; The indicator segment comprises: a carrier layer located in the inner layer and a braided layer covering the outside of the carrier layer; The supporting layer is composed of medical fiber bundles, and the braided layer is formed by weaving fibers with an initial braiding angle, braiding density and single-line diameter; There is a color difference between the carrier layer and the braided layer; As the tension on the surgical suture increases, the coverage of the braided layer on its supporting layer decreases.

[0006] Secondly, embodiments of this application provide a tension calibration method based on the aforementioned double-layer braided surgical suture, the method comprising: The surgical sutures were stretched axially, and the first images of the indicator segment were acquired under different axial tensions. Based on the first image, calculate the first coverage of the braided layer; Determine a first mapping relationship between the axial tension and the first coverage rate.

[0007] Thirdly, embodiments of this application provide a tension calibration method based on the aforementioned double-layer braided surgical suture, the method comprising: Ligation was performed using surgical sutures, and second images of the indicator segment were acquired under different ligation tensions. Based on the second image, calculate the second coverage of the braided layer; Determine a second mapping relationship between the ligation tension and the second coverage rate.

[0008] Fourthly, embodiments of this application provide a visualization method for monitoring surgical suture tension, based on the aforementioned double-layer braided surgical suture, the method comprising: Acquire the current image of the specified segment; Based on the current image, calculate the current coverage of the weave layer; Based on the pre-calibrated mapping relationship between tension and coverage, the current tension corresponding to the current coverage is determined; Display the current tension or a prompt message generated by the current tension.

[0009] Fifthly, embodiments of this application provide a visualization system for monitoring surgical suture tension, based on the aforementioned double-layer braided surgical suture, the system comprising: The acquisition module is configured to acquire the current image of the indicated segment; The calculation module is configured to calculate the current coverage of the weave layer based on the current image; The determination module is configured to determine the current tension corresponding to the current coverage rate based on a pre-calibrated mapping relationship between tension and coverage rate. The display module is configured to display the current tension and / or prompt information generated by the current tension.

[0010] This application provides a tension-indicating double-layer braided surgical suture and a tension calibration method. It employs an integrated structure where the suture body and at least one indicator segment are sequentially connected along its length. Within the indicator segment, a carrier layer with color difference and a braided layer composed of a specific initial braiding angle, braiding density, and single-thread diameter are provided. This allows the suture to physically reduce the coverage of the carrier layer by the braided layer when subjected to suturing or ligation tension. This transforms the traditional tension judgment process, which relies on the doctor's touch and discrete signals, into a continuous, progressive visual perception process based on the degree of color visibility of the inner suture layer. Since the visual feedback is entirely based on the physical structural deformation and inherent color difference of the suture itself, it eliminates the need for integrated electronic sensors and conductive polymers, thus significantly reducing the manufacturing cost and clinical application threshold of smart sutures.

[0011] By setting a single-layer suture body and a double-layer indicator segment, the conventional suture mechanical function and tension indication function are decoupled in physical structure. This allows the indicator segment to respond precisely based on independent weaving parameters, thus avoiding the problem of decreased conventional suture strength or unstable ligation caused by parameter adjustments to the overall suture. This application replaces robot components that rely on complex torque sensors or tactile feedback systems with simple visual color difference feedback, significantly reducing the hardware integration cost and algorithm overhead of the intelligent surgical system without compromising tension sensing effectiveness. Simultaneously, the support layer is composed of medical fiber bundles. The bundle structure has characteristics such as large specific surface area and high softness, which not only allows for full and stable color difference through solution dyeing or surface dyeing techniques, but also ensures the overall smoothness and knotting smoothness of the suture, reducing the risk of suture cutting and damage to fragile tissues. Attached Figure Description

[0012] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0013] Figure 1 This is a schematic diagram of a tension-indicating double-layer braided surgical suture provided in one embodiment of this application; Figure 2 This is a flowchart of a tension calibration method provided in one embodiment of this application; Figure 3 This is a flowchart of a tension calibration method provided in another embodiment of this application; Figure 4 This is a flowchart illustrating a visualization method for monitoring surgical suture tension, provided in one embodiment of this application. Figure 5 This is a schematic diagram of different tension zones provided in one embodiment of this application; Figure 6 This is a schematic diagram illustrating the mapping relationship between tension and coverage, provided in one embodiment of this application; Figure 7 This is a schematic diagram illustrating a display of prompt information provided in one embodiment of this application; Figure 8 This is a schematic diagram of a visualization system for monitoring surgical suture tension, provided in one embodiment of this application. Figure 9 This is a schematic diagram of a tension calibration device provided in one embodiment of this application; Figure 10This is a schematic diagram of a tension calibration device provided in one embodiment of this application. Detailed Implementation

[0014] To enable those skilled in the art to better understand the technical solutions of the embodiments of this application, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0015] like Figure 1 As shown, this application provides a double-layer braided surgical suture that can indicate tension, comprising: a suture body and at least one indicator segment.

[0016] The suture body and at least one indicator segment are sequentially connected along the length of the suture body.

[0017] The indicator section includes: a carrier layer located on the inner layer and a braided layer covering the outside of the carrier layer.

[0018] The supporting layer is composed of medical fiber bundles, and the braided layer is formed by fiber braiding with initial braiding angle, braiding density and single thread diameter.

[0019] There is a color difference between the carrier layer and the braided layer.

[0020] As the tension on the surgical suture increases, the coverage of the braided layer on its supporting layer decreases.

[0021] Surgical sutures are not entirely double-layered; they are segmented, with most being ordinary single-layered sutures used for needle insertion, knotting, and bearing principal stress. Indicator segments are only located at specific positions, such as near the needle tip or near the nodule. Multiple indicator segments can be placed in different sections of the suture to meet the needs of observation from different angles during surgery.

[0022] The indicator segment is not an external attachment or glued to the suture, but a continuous suture manufactured using an integrated process, ensuring the overall mechanical strength and biocompatibility of the suture. By placing the indicator segment in the area most easily observed by the surgeon or endoscope, such as near the needle tip or close to the ligation point, the surgeon can receive visual feedback simultaneously as the suture is tightened, without the need for additional equipment.

[0023] The outer braided layer is overlaid on the inner layer, without physical fusion or forced bonding between them. This tiny slip gap allows the outer layer to undergo free physical deformations such as changes in braid angle and mesh enlargement when subjected to tension, without being restrained by the inner layer, resulting in reduced coverage. The main function of the inner supporting layer is to ensure the overall tensile strength of the stitching and to serve as a color-developing base.

[0024] Fiber bundles refer to multifilament assemblages composed of multiple fine monofilaments arranged in parallel or slightly twisted. Compared to a single solid monofilament, a fiber bundle has a larger specific surface area, enabling it to absorb more medical masterbatch, resulting in richer and more vibrant colors that are easier to observe visually. The fiber bundle also exhibits high overall softness and smooth knotting, meeting the clinical requirements for surgical sutures and preventing hard monofilaments from causing cutting damage to surrounding tissues.

[0025] The initial weave angle determines the tightness of the mesh. The larger the weave angle, the stronger the longitudinal extension of the thread when it is under tension, and the easier it is for the mesh to become larger.

[0026] The weaving density determines the number of weaving nodes per unit length. The higher the density, the smaller the initial pores, the better the shading effect, and the greater the resistance.

[0027] The diameter of a single filament determines the thickness of the yarn that makes up the yarn, which directly affects the area of ​​light blocked by a single filament.

[0028] There is a color difference between the inner carrier layer and the outer braided layer that can be detected by visual or image recognition systems. The greater the color difference and the stronger the color contrast, the higher the resolution of the tension indication. Under the illumination of a clinical endoscopic light source, the high-contrast color difference can effectively counteract background interference from blood, body fluids, etc., ensuring clear readings.

[0029] For example, the inner carrier layer is made dark using solution dyeing technology, while the outer woven layer is made of white or light gray natural medical-grade polyester or nylon monofilaments. In its initial state, the densely woven white or light gray outer layer covers the dark inner layer. When stretched, the woven mesh expands, allowing the dark inner layer to show through the white mesh, creating a striking visual contrast.

[0030] Under axial tension, the braiding angle of the braided layer increases rapidly, causing the originally closely adjacent braided fibers to separate to both sides, resulting in a larger mesh. Since the diameter of the single yarn in the outer layer remains unchanged, while the circumference of the inner layer decreases, coupled with the larger mesh, the effective shielding area of ​​the outer layer fibers on the inner layer bundles is significantly reduced.

[0031] For example, initially, the outer braided layer covers the inner layer with a coverage of nearly 90%, making the inner layer almost invisible. When an axial tension of, for example, 5N is applied, the braid angle increases from 45° to 50°, the spacing between the outer fibers widens, and the inner layer's color begins to appear as dots or short stripes, faintly visible. When the tension increases to 15N, the braid angle further increases to 60°, and the mesh expands enough to allow the inner layer to display continuous blue spiral stripes. At this point, the coverage drops to around 0.35, and doctors can determine that the target safe tension has been reached by observing a large area of ​​color development. When the tension exceeds 20N, the braid angle approaches 70°, and the coverage may drop below 0.3, exposing a large area of ​​the dark inner layer. Based on this, the naked eye can determine that there is a risk of suture breakage or tissue ischemia-induced cutting.

[0032] This application employs an integrated structure where the suture body and at least one indicator segment are sequentially connected along the length direction. Within the indicator segment, a carrier layer with color difference and a braided layer composed of a specific initial braiding angle, braiding density, and single-thread diameter are provided. This allows the suture, when subjected to suturing or ligation tension, to physically reduce the coverage of the carrier layer by the braided layer. This transforms the traditional tension judgment process, which relies on the doctor's touch and discrete signals, into a continuous, progressive visual perception process based on the degree of color visibility within the suture's inner layer. Since the visual feedback is entirely based on the suture's own physical structural deformation and inherent color difference, there is no need to integrate electronic sensors or conductive polymers, thus significantly reducing the manufacturing cost and clinical application threshold of smart sutures.

[0033] This application decouples the conventional suture mechanical function from the tension indication function in terms of physical structure by setting a single-layer suture body and a double-layer indicator segment. This allows the indicator segment to respond precisely based on independent weaving parameters, thereby avoiding the problem of decreased conventional suture strength or unstable ligation caused by parameter adjustments to the overall suture. This application replaces robotic components that rely on complex torque sensors or tactile feedback systems with simple visual color difference feedback, significantly reducing the hardware integration cost and algorithm overhead of the intelligent surgical system without compromising tension sensing effectiveness. Simultaneously, the support layer is composed of medical fiber bundles. The bundle structure has characteristics such as large specific surface area and high softness, which not only allows for full and stable color difference through solution dyeing or surface dyeing techniques, but also ensures the overall smoothness and knotting smoothness of the suture, reducing the risk of suture cutting and damage to fragile tissues.

[0034] In one embodiment of this application, the medical fiber bundle is selected from at least one of polyamide, polyester, polyglycolic acid, and polylactic-co-hydroxyacetic acid copolymer.

[0035] This application embodiment limits the medical fiber bundles of the inner bearing layer to at least one selected from polyamide, polyester, polyglycolic acid and polylactic acid-glycolic acid copolymer, which not only endows the surgical suture with excellent biocompatibility and reliable mechanical strength, but also enables the suture to flexibly select non-absorbable or absorbable materials according to the tissue healing cycle and tension requirements of different clinical surgical scenarios, thus achieving wide adaptability to different surgical procedures.

[0036] Specifically, by selecting polyamides and polyesters, stable and durable tensile strength can be provided for suture areas requiring long-term or permanent tension support, such as abdominal wall tension reduction and fascial sutures. By selecting polyglycolic acid and polylactic-co-glycolic acid copolymers, safe support can be provided for suture areas requiring temporary fixation and subsequent self-degradability, such as visceral organ anastomosis and subcutaneous tissue sutures, avoiding the risk of tissue foreign body reactions or secondary surgery for suture removal that may be caused by long-term suture retention in the body.

[0037] Because the aforementioned materials all possess excellent fiber-forming properties and thermal stability in melt spinning processes, they can achieve good compatibility with medical-grade masterbatches or colorants. This ensures that the inner carrier layer can be endowed with stable, high-contrast, and vibrant colors during the manufacturing process, in order to match the physical deformation of the outer braided layer as tension increases, thereby achieving precise tension visualization.

[0038] In one embodiment of this application, the initial coverage of the braided layer is determined by the initial braiding angle, braiding density, and fiber diameter of the single yarn, and the initial coverage of the braided layer is 0.85~0.95.

[0039] In the initial state where the surgical suture is not subjected to any tension loading, the effective shielding ratio of the outer braided layer to the inner bearing layer is controlled within the range of 0.85 to 0.95.

[0040] When sutures are used specifically for low-tension ligation scenarios such as vascular and nerve anastomosis, their initial coverage can be set in the lower range of 0.85 to 0.90. This ensures that the outer layer can quickly reduce its coverage under very small tension (such as 1 to 3 N), allowing doctors to perceive the tension change immediately and preventing fragile vascular tissue from being strangled.

[0041] When sutures are used specifically for high-tension suturing scenarios such as fascia and abdominal wall tension reduction, their initial coverage can be set in the higher range of 0.90 to 0.95 to ensure that the outer layer can still maintain relatively good shielding before being subjected to moderate or target safe tension (such as 10 to 15 N), preventing doctors from misjudging and stopping the application of force.

[0042] This embodiment enables the surgical suture to effectively and strongly shield the outer bearing layer when not under tension, preventing the inner layer color from prematurely revealing itself under no stress and ensuring a stable and uniform appearance of the suture in its initial state. Simultaneously, the initial coverage rate established through the aforementioned parameters provides a precise physical reference starting point for establishing the subsequent tension-coverage mapping relationship, allowing the suture's coverage rate to reliably decrease non-linearly from a tight state of 0.85 to 0.95 when under tension.

[0043] Coverage rate refers to the ratio of the area obscured by the outer braided layer to the inner carrier layer within the effective reading area of ​​the indicator segment. The effective reading area refers to a pre-defined boundary interval within the indicator segment used for coverage rate statistics of pixels.

[0044] Initial coverage C 0 is determined by equations (1) and (2).

[0045] (1) (2) in, φ 0 represents the unidirectional fill factor. d The diameter of a single line. P For weaving density, α This is the initial weaving angle.

[0046] In one embodiment of this application, there are multiple indicator segments; under the same tension, the coverage of each indicator segment is different.

[0047] The suture body does not have just one indicator segment, but two or more indicator segments. These indicator segments are distributed in different physical locations along the length of the suture, such as near the needle tip, in the middle of the suture, or near the ligation point.

[0048] The purpose of setting multiple indicator segments is to accommodate the needs of different minimally invasive surgical techniques, different surgical perspectives, and different observation habits. In clinical surgery, the surgeon's field of vision is often limited by the angle of the endoscope, the operating space, or tissue obstruction. If only one indicator segment is set in one location, the surgeon will be unable to obtain any visual feedback on tension if that area is obstructed by blood, tissue, instruments, or is in a blind spot. By setting multiple indicator segments, it can be ensured that at any stage of suture tightening, at least one indicator segment is within the clear field of vision of the surgeon or the endoscope camera, thus guaranteeing the continuity and reliability of tension indication.

[0049] like Figure 2 As shown, this application provides a tension calibration method based on any of the above embodiments of double-layer braided surgical sutures. The method includes: Step 201: Axially stretch the surgical suture and acquire the first image of the indicator segment under different axial tensions.

[0050] Axial tension is a fundamental stress form for surgical sutures in clinical suturing operations. During the calibration experiment, by setting multi-level gradient tensions, such as 0N, 5N, 10N, 15N, and 20N, the entire working range from initial relaxation to safe tension, and even to ultimate overload, can be fully covered.

[0051] Step 202: Calculate the first coverage of the braided layer based on the first image.

[0052] By setting a fixed effective reading area and calculating the ratio of the pixel area belonging to the outer layer that obscures the inner layer to the total pixel area within that area, a precise value between 0 and 1 is obtained. The first coverage rate specifically refers to the coverage rate under axial tension conditions, which is different from the coverage rate under subsequent ligation conditions.

[0053] Step 203: Determine the first mapping relationship between axial tension and first coverage rate.

[0054] Without ligation or bending, and under only straight tension, the amount of color the suture should show corresponds to the actual tension. This calibration can generate a calibration table or mathematical model. In subsequent clinical use or robotic system applications, the system only needs to measure the current coverage in real time and, by looking up this mapping relationship, can deduce the actual tension value on the suture.

[0055] The axial tension calibration process of the double-layer braided surgical suture in this application is as follows: First, the surgical suture to be calibrated is fully immersed in a constant temperature and humidity environment of 37°C to simulate the actual working conditions inside the human body. Then, both ends of the suture are clamped on a universal testing machine, with a fixed clamping length and a constant loading speed set to ensure that the indicator segment is located in the center of the clamping area. The testing machine is started to axially stretch the suture. When the feedback value of the real-time tension sensor of the testing machine reaches the preset discrete gradient sampling point, the loading is paused and the tension value is maintained. Images of the indicator segment are recorded when the suture tension is 0 N, 5 N, 10 N, 15 N, and 20 N, respectively. The images acquired under the above gradient tension are processed using computer vision algorithms, and the pixel area of ​​the inner layer color occluded within the effective reading area is counted to calculate the coverage rate corresponding to each tension gradient. The following mapping relationship is established between coverage and tension state: a coverage rate of 0.7~0.9 is defined as the low tension zone, a coverage rate of 0.4~0.7 is defined as the medium tension zone, and a coverage rate of 0.3~0.4 is defined as the target safe tension zone. Figure 6The target tension zone is defined as a coverage area less than or equal to 0.3, indicating that the current tension has seriously exceeded the safe ligation range, which may cause tissue ischemia, cutting, or suture breakage.

[0056] In one embodiment of this application, the first mapping relationship is a piecewise linear function, a power function, a logical function, or a lookup table function.

[0057] This application provides diverse underlying mathematical model support for surgical suture tension visualization systems, enabling surgical robots or image acquisition systems to flexibly select the most suitable data processing method based on their hardware computing power configuration and real-time requirements. For example, in medical device microprocessors with extremely limited computing resources, lookup table functions or piecewise linear functions can complete tension back-calculation with minimal hardware overhead and clock cycles, ensuring the real-time response capability of the surgical monitoring system. In high-end robot systems equipped with high-performance image processing chips, smooth fitting using power functions or logical functions can eliminate data jumps between discrete nodes, providing more continuous, smooth, and physically realistic tension estimates.

[0058] like Figure 3 As shown, this application provides a tension calibration method based on the double-layer braided surgical suture of any of the above embodiments. The method includes: Step 301: Perform ligation based on surgical sutures and acquire second images of the indicator segment under different ligation tensions.

[0059] In actual clinical surgery, the key step in generating tension in the sutures and triggering color development is knotting and fixation. However, the stress in the knotted state is not a simple uniaxial tension. The suture undergoes severe local bending at the knot; when the knot is tightened, the tissue or knot body exerts strong radial compression on the suture; and there are also complex frictional and shearing effects between the sutures. These superimposed mechanical effects cause the indicator segment near the knot area to produce deformation that is completely different from that of straight tension. Therefore, a second image must be acquired while the suture is ligated to obtain objective data that can truly reflect the stress situation in the knot area.

[0060] Step 302: Calculate the second coverage of the braided layer based on the second image.

[0061] In the second image, since the suture may be locally twisted at the ligation site, it is necessary to first identify and lock the rigid centerline of the indicator segment, and establish a dynamic effective reading frame perpendicular to the centerline and covering the deformation width of the indicator segment. Because the exposed area in the ligation zone is no longer a uniform grid, a deep learning semantic segmentation algorithm, rather than simple thresholding, can be used to accurately extract all irregular exposed areas in the ligation indicator segment caused by compression and misalignment. The proportion of the irregular exposed area pixel area to the total pixel area within the dynamic effective reading frame is calculated to obtain the second coverage rate.

[0062] Step 303: Determine the second mapping relationship between ligation tension and second coverage rate.

[0063] In practical applications, it can simulate the real clinical force application process under different knot types, knot distances, and knot counts. For example, different knot types correspond to different second mapping relationships.

[0064] In one embodiment, to provide accurate tension visualization feedback for double-layer braided surgical sutures during clinical knotting or ligation, the nearest end distance of the indicator segment from the predetermined knot center or knot edge is defined as the knot location parameter L. k Based on the actual suture specifications and clinical needs, the knot location parameter L... k It can be set within the range of 0.5~20 mm, preferably 1~8 mm. If L k If the value is too small, the indicator segment is easily obscured by the structure or drawn into the structure, resulting in obscurity or misreading; if L k If the value is too large, the influence of local bending and compression on the indicator segment in the knot region will be weakened, and its ability to reflect the true tension state of the knot region will decrease. Therefore, it is important to choose L appropriately. k Numerical values ​​are crucial to ensuring that the indicator section has both visual reading conditions and can effectively reflect the effective tightening state of the knot area.

[0065] This embodiment provides two differentiated adaptation schemes to address different tissue types and ligation requirements: (I) Low-tension ligation scenario adaptation solution: When surgical sutures are used in scenarios such as vascular anastomosis and suturing of perineural tissues, where the ligation force requirement is extremely low and the tissue is relatively fragile, the indicator segment can be set closer to the ligation node, so that L k The value is 1~4 mm. Simultaneously, the weaving density of the outer braided layer is reduced in the manufacturing process, lowering the initial coverage, and an outer fiber material with a low elastic modulus and high deformability is selected. Through this combined design, the local bending, compression, and shearing forces generated when the ligation point is tightened can more easily cause deformation of the outer braided layer, thus triggering a noticeable color change in the indicator segment under extremely low ligation force, achieving highly sensitive alerting and protection of fragile tissues.

[0066] (II) High-Tension Ligation Scenario Adaptation Solution: When surgical sutures are used in scenarios requiring resistance to significant physiological loads and high ligation force, such as fascial suturing and abdominal wall tension-reducing suturing, the indicator segment can be set at a suitable distance from the ligation point, so that L... k The value is 4~8 mm. Simultaneously, the weaving density of the outer braided layer is increased in the manufacturing process to improve initial coverage, and an outer fiber material with a higher elastic modulus and a more compact structure is selected. Through this combined design, the outer braided layer can maintain a high initial shielding force even when subjected to local compression and bending near the knot area. Only when the ligation force reaches or exceeds the target safety tension does a significant decrease in coverage and color reaction occur, providing a reliable indication of ligation strength for high-tension tissues.

[0067] like Figure 4 As shown, this application provides a visualization method for monitoring surgical suture tension, based on any of the above embodiments using double-layered braided surgical sutures. The method includes: Step 401: Acquire the current image of the indicator segment.

[0068] Step 402: Calculate the current coverage of the weave layer based on the current image.

[0069] Step 403: Based on the pre-calibrated mapping relationship between tension and coverage, determine the current tension corresponding to the current coverage.

[0070] This method is applicable to both axial tension and ligation tension. For axial tension, the first mapping relationship is used, and for ligation tension, the second mapping relationship is used.

[0071] like Figure 5 and 6 As shown, in the low-tension zone, medium-tension zone, and high-tension zone, the tension increases sequentially, and the coverage decreases as the tension increases.

[0072] Step 404: Display the current tension and / or a prompt message generated by the current tension.

[0073] For example, on the edge of the endoscopic monitor or on a dedicated surgical monitor, text prompts such as "Current tension: 13.2N," "Target safe tension: 5~15 N," and "Warning: Overload!" are displayed simultaneously. Figure 7 As shown.

[0074] This visualization method eliminates the reliance on the surgeon's personal tactile sensitivity in traditional surgery, transforming purely subjective tactile sensation into quantifiable, dynamically evolving objective numbers. This allows surgeons to simultaneously obtain numerical mechanical references and intuitive safety threshold warnings during the stressful surgical process.

[0075] In one embodiment of this application, the current coverage rate is [0.3-0.4], and the prompt information is used to indicate that the current tension has reached the preset target safety tension; if the current coverage rate is less than 0.3, the prompt information is used to indicate that the current tension exceeds the target safety tension.

[0076] By setting the current coverage rate of 0.3~0.4 as the threshold for determining whether the target safe tension has been met, and setting the current coverage rate of less than 0.3 as the warning threshold for tension overload, doctors can quickly and accurately decide whether to apply force, stop, or loosen the line simply by observing the text prompts or alarm signals that pop up on the screen, greatly reducing the delay in operational decisions.

[0077] like Figure 8 As shown, this application embodiment provides a visualization system for monitoring surgical suture tension. Based on any of the above-mentioned double-layer braided surgical sutures, the system includes: Acquisition module 801 is configured to acquire the current image of the indicator segment; Calculation module 802 is configured to calculate the current coverage of the weave layer based on the current image; The determination module 803 is configured to determine the current tension corresponding to the current coverage rate based on the pre-calibrated mapping relationship between tension and coverage rate. Display module 804 is configured to display the current tension and / or prompt information generated by the current tension.

[0078] like Figure 9 As shown, this application provides a tension calibration device based on any of the above embodiments of double-layer braided surgical sutures. The device includes: The first acquisition module 901 is configured to axially stretch the surgical suture and acquire the first image of the indicator segment under different axial tensions. The first calculation module 902 is configured to calculate the first coverage of the braided layer based on the first image; The first determining module 903 is configured to determine a first mapping relationship between axial tension and first coverage rate.

[0079] like Figure 10 As shown, this application provides a tension calibration method based on any of the above embodiments of double-layer braided surgical sutures. The device includes: The second acquisition module 1001 is used to acquire second images of the indicator segment under different ligation tensions based on surgical sutures. The second calculation module 1002 is configured to calculate the second coverage of the braided layer based on the second image; The second determining module 1003 is configured to determine a second mapping relationship between ligation tension and second coverage rate.

[0080] This application provides an electronic device, including a memory and a processor. The memory stores an executable program, and the processor executes the executable program to perform the steps of the methods described in any of the above embodiments.

[0081] This application provides a computer program product that, when executed by a processor, implements the methods of any of the above embodiments.

[0082] It should be understood that in the embodiments of this application, the processor may be a central processing unit (CPU), or it may be other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc.

[0083] It should also be understood that the memory mentioned in the embodiments of the present invention can be volatile memory or non-volatile memory, or may include both volatile and non-volatile memory. Specifically, non-volatile memory can be read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), or flash memory. Volatile memory can be random access memory (RAM), which is used as an external cache. By way of example, but not limitation, many forms of RAM are available, such as Static RAM (SRAM), Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDR SDRAM), Enhanced Synchronous DRAM (ESDRAM), Synchlink DRAM (SLDRAM), and Direct Rambus RAM (DR RAM).

[0084] It should be noted that when the processor is a general-purpose processor, DSP, ASIC, FPGA, or other programmable logic device, discrete gate or transistor logic device, or discrete hardware component, the memory (storage module) is integrated into the processor.

[0085] It should be noted that the memories described herein are intended to include, but are not limited to, these and any other suitable types of memories.

[0086] In addition to the data bus, this bus may also include a power bus, a control bus, and a status signal bus. However, for clarity, all buses are labeled "bus" in the diagram.

[0087] It should also be understood that the first, second, third, fourth and various numerical designations used herein are merely for descriptive convenience and are not intended to limit the scope of this application.

[0088] In implementation, each step of the above method can be completed by integrated logic circuits in the processor's hardware or by instructions in software. The steps of the method disclosed in the embodiments of this application can be directly implemented by a hardware processor, or by a combination of hardware and software modules in the processor. The software modules can reside in random access memory, flash memory, read-only memory, programmable read-only memory, electrically erasable programmable memory, registers, or other mature storage media in the art. This storage medium is located in memory, and the processor reads information from the memory and, in conjunction with its hardware, completes the steps of the above method. To avoid repetition, detailed descriptions are omitted here.

[0089] In the various embodiments of this application, the order of the above-mentioned processes does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0090] Those skilled in the art will recognize that the various illustrative logical blocks (ILBs) and steps described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this application.

[0091] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative; for instance, the division of 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 system, or some features may be ignored or not executed. Furthermore, the 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.

[0092] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0093] In addition, 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.

[0094] In the above embodiments, implementation can be achieved entirely or partially through software, hardware, firmware, or any combination thereof. When implemented using software, it can be implemented entirely or partially in the form of a computer program product. The computer program product includes one or more computer instructions. When the computer program instructions are loaded and executed on a computer, all or part of the processes or functions described in the embodiments of this application are generated. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center via wired (e.g., coaxial cable, fiber optic, digital subscriber line) or wireless (e.g., infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium that a computer can access or a data storage device such as a server or data center that integrates one or more available media. The available medium can be a magnetic medium (e.g., floppy disk, hard disk, magnetic tape), an optical medium (e.g., DVD), or a semiconductor medium (e.g., solid-state drive), etc.

[0095] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology 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 tension-indicating double-layer braided surgical suture, characterized in that, include: The suture body and at least one indicator segment; Wherein, the suture body and the at least one indicator segment are sequentially connected along the length direction of the suture body; The indicator segment comprises: a carrier layer located in the inner layer and a braided layer covering the outside of the carrier layer; The supporting layer is composed of medical fiber bundles, and the braided layer is formed by weaving fibers with an initial braiding angle, braiding density and single-line diameter; There is a color difference between the carrier layer and the braided layer; As the tension on the surgical suture increases, the coverage of the braided layer on its supporting layer decreases.

2. The double-layer braided surgical suture as described in claim 1, characterized in that, The medical fiber bundle is selected from at least one of polyamide, polyester, polyglycolic acid and polylactic acid-glycolic acid copolymer.

3. The double-layer braided surgical suture as described in claim 1, characterized in that, The initial coverage of the braided layer is determined by the initial braiding angle, braiding density, and fiber diameter of the single thread, and the initial coverage of the braided layer is 0.85~0.

95.

4. The double-layer braided surgical suture as described in claim 1, characterized in that, The indicator segment has multiple segments; Under the same tension, the coverage of each indicator segment is different.

5. A tension calibration method, characterized in that, Based on the double-layer braided surgical suture according to any one of claims 1-4, the method comprises: The surgical sutures were stretched axially, and the first images of the indicator segment were acquired under different axial tensions. Based on the first image, calculate the first coverage of the braided layer; Determine a first mapping relationship between the axial tension and the first coverage rate.

6. The tension calibration method as described in claim 5, characterized in that, The first mapping relationship is a piecewise linear function, a power function, a logical function, or a lookup table function.

7. A tension calibration method, characterized in that, Based on the double-layer braided surgical suture according to any one of claims 1-4, the method comprises: Ligation was performed using surgical sutures, and second images of the indicator segment were acquired under different ligation tensions. Based on the second image, calculate the second coverage of the braided layer; Determine a second mapping relationship between the ligation tension and the second coverage rate.

8. A visualization method for monitoring surgical suture tension, characterized in that, Based on the double-layer braided surgical suture according to any one of claims 1-4, the method comprises: Acquire the current image of the specified segment; Based on the current image, calculate the current coverage of the weave layer; Based on the pre-calibrated mapping relationship between tension and coverage, the current tension corresponding to the current coverage is determined; Display the current tension and / or a prompt message generated by the current tension.

9. The visualization method as described in claim 8, characterized in that, When the current coverage rate is [0.3-0.4], the prompt message is used to indicate that the current tension has reached the preset target safety tension; When the current coverage rate is less than 0.3, the prompt message is used to indicate that the current tension exceeds the target safe tension.

10. A visualization system for monitoring surgical suture tension, characterized in that, Based on the double-layer braided surgical suture according to any one of claims 1-4, the system comprises: The acquisition module is configured to acquire the current image of the indicated segment; The calculation module is configured to calculate the current coverage of the weave layer based on the current image; The determination module is configured to determine the current tension corresponding to the current coverage rate based on a pre-calibrated mapping relationship between tension and coverage rate. The display module is configured to display the current tension and / or prompt information generated by the current tension.

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