Gynecological suturing needle thread set for surgery and matching method, manufacturing method

Abstract

The present application relates to a kind of gynecological suture operation based on high-performance biomedical polymer material suture needle and thread kit and matching method, manufacturing method, to solve the problem such as insufficient suture line supporting force, easy to cut tissue and needle hole leakage in gynecological operation, manufacturing method uses specific specification polyester fiber, by the independent tension control of warp yarn, and using flat-end shuttleless loom weaving and high-temperature long-time heat setting, it is made into flat suture line with low elongation and high form stability.The tail end of suture needle in kit is provided with radially compressed closure lateral open, for from side and clamp the flat suture line.The needle body diameter of suture needle and the effective filling diameter of flat suture line under stress match, realize the close closure of needle hole.The scheme of the present application can provide reliable long-acting tissue support, reduce tissue damage, prevent leakage, improve the safety and convenience of overall operation, improve the clinical effect of gynecological operation, especially cervical cerclage.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of biomedical polymer materials, and particularly relates to a suture needle and thread kit for gynecological suturing operations and a matching method and a manufacturing method. BACKGROUND

[0002] In surgical operations, suture needles and suture threads are basic medical instruments for tissue suturing and wound closure. In the field of gynecological operations, especially for patients with cervical incompetence, special operations such as cervical cerclage are performed, and the performance of the suture needle and thread kit is required to be more stringent. The core purpose of cervical cerclage is to provide additional mechanical support for the weak cervix by suturing the thread around the cervix at the level of the internal orifice and tightening it, so as to maintain pregnancy to full term. However, the suture needle and thread products in the prior art still have a series of interrelated technical bottlenecks when dealing with such application scenarios.

[0003] 1. Limitations of the suture thread itself in terms of force bearing and tissue compatibility:

[0004] Traditional medical suture threads are mostly of circular cross-sectional structure. When performing cervical cerclage and other operations that require the application and long-term maintenance of a large tightening force, the thin strip-shaped circular suture thread will highly concentrate the pressure in the narrow area in contact with the tissue, and the unit area pressure is extremely large. This is easy to produce "cheese-wiring effect" on the soft and blood-rich tissue such as the cervix, leading to local tissue ischemia, edema and even necrosis, which may cause complications such as infection and bleeding, and more seriously, the suture thread will gradually embed or cut through the cervical tissue, thereby losing its intended support function, which may lead to operation failure.

[0005] To solve the above problems, the industry has proposed the idea of using flat tape-like sutures, which have a wide surface that can effectively distribute pressure. However, the manufacturing technology and product performance of existing flat sutures still have deficiencies. First, some existing textile processes cannot stably produce medical-grade narrow tape sutures with precise dimensions, smooth surfaces, and uniform width and thickness, and the batch-to-batch differences in the product can affect the effectiveness and reliability of clinical use. Second, and more importantly, existing flat sutures, especially those manufactured based on ordinary textile processes, often have high extensibility. In the application of cervical cerclage, the suture will continue to bear pressure from the uterine cavity and the fetus after implantation. If the suture material itself has a high elongation rate, it will creep or elastically stretch under continuous load, causing the cerclage ring to gradually relax and unable to provide stable and long-lasting mechanical support, which poses a potential risk of long-term surgical failure. Therefore, how to produce a high-performance flat suture that can not only distribute pressure but also has low elongation to provide rigid support is a technical problem that needs to be solved in this field.

[0006] 2. Inadequacy of the functional cooperation of suture needles and sutures:

[0007] The safety and effectiveness of the suture operation not only depends on the suture, but also relies on the suture needle and the precise cooperation of the two.

[0008] First, in terms of puncture trauma, gynecological surgery (such as cervical and myometrial suturing) involves tissues that are usually fragile and rich in blood vessels. Traditional sharp suture needles inevitably cause cutting damage to tissue fibers and microvessels during puncture, increasing the risk of intraoperative bleeding and potentially affecting tissue healing.

[0009] Second, in terms of needle hole leakage, the tightness of the needle hole is crucial after cervical cerclage, as any bleeding or amniotic fluid leakage can increase the risk of infection and even threaten pregnancy safety. In existing technology, this problem is usually attempted to be solved by simply matching the static geometric diameter of the needle body with the static geometric diameter of the suture. However, this matching method ignores the dynamic behavior of flat sutures when they are forced to pass through the tissue tunnel formed by the needle body - flat sutures will deform by folding, curling, etc. The existing technology fails to provide a scientific pairing method based on the dynamic filling characteristics of the suture, resulting in a small gap between the needle hole and the suture, making it difficult to fundamentally achieve effective embolization and anti-leakage of the needle hole.

[0010] Thirdly, in terms of reliability and operability of needle-thread connection, the traditional needle tail structure (such as perforated needle eye) has difficulty in cooperating with flat suture thread. Forced insertion is not only inconvenient to operate, but also may damage the structural integrity of the flat suture thread. Some connection methods without needle eye may have insufficient connection strength, and there is a risk of thread and needle separation when the suture is stressed.

[0011] In summary, although the prior art has improved the single link of suture needle or suture thread, it lacks a systematic solution from the precise manufacturing of high-performance flat suture thread, to the scientific pairing of needle-thread based on functional matching, to the optimization of the overall kit structure. Therefore, in the field of biomedical polymer materials and their applications, there is an urgent need for a new type of gynecological suture operation suture needle thread kit and related manufacturing and pairing method, which can cooperatively solve the above problems. SUMMARY

[0012] In order to solve the problems of the prior art, the present application provides an innovative solution in the preparation and application of biomedical polymer materials, a gynecological suture operation suture needle thread kit and pairing method, and a manufacturing method. It not only provides flat suture thread with low elongation rate and high shape stability to achieve long-term and reliable tissue support, but also effectively prevents needle hole leakage through precise functional cooperation between needle and thread, and improves the safety and convenience of overall operation, thereby significantly improving the clinical effect of gynecological surgery, especially cervical cerclage.

[0013] The gynecological suture operation suture needle thread kit of the present application is composed of a suture needle and a flat suture thread, which can be pre-connected as a whole.

[0014] First, the suture needles in this kit have a specific structural design with a blunt tip, a non-sharp, rounded tip shape. In gynecological surgeries, such as cervical cerclage, the tissues in the surgical area (such as the cervix) are typically soft, fragile, and highly vascularized. The blunt tip advances through such tissue primarily by pushing and separating tissue fibers rather than by sharp cutting, a mechanism designed to reduce direct puncture damage to tissues and blood vessels. The needle body surface features an anti-slip structure, such as grooves or textures distributed along the needle body. During the procedure, the surgeon uses a needle holder to hold the needle body. The gynecological surgical environment is often slippery; this anti-slip structure increases the static friction between the needle holder jaws and the needle body, ensuring that the suture needle does not accidentally slip or rotate within the holder when puncture force is applied or the needle body is rotated, thus guaranteeing the surgeon's stability and precise control over the puncture point, path, and depth. The needle tail is designed with a lateral opening. Unlike traditional closed needle eye designs, this structure forms an open channel or groove on the side of the needle tail, extending all the way to the end face of the needle. This open design allows flat sutures to be inserted directly from the side without the need for traditional threading.

[0015] Secondly, the flat suture in this kit also has a specific shape. It has a flat, strip-like structure with a preset width-to-thickness ratio (e.g., the width is significantly greater than the thickness) and a smooth surface. This shape allows it to form a wider contact surface when in contact with human tissue. Throughout the kit, the suture needle and flat suture are connected and engaged in a specific manner: one end of the flat suture is laterally inserted and secured in a lateral opening structure at the suture needle tail. Specifically, during assembly, the end of the flat suture is inserted into the opening from the side, and then external pressure is applied to the needle tail (e.g., by pressing during pre-processing using a special clamp), causing the lateral opening structure to deform and close, thereby firmly clamping and securing the flat suture within.

[0016] Furthermore, the lateral opening structure includes a needle end clamp and a lateral groove formed on the side and end face of the needle end clamp; the flat suture is laterally embedded into the needle end clamp through the lateral groove; the lateral groove closes and clamps the flat suture after the needle end clamp is deformed by external pressure. Specifically, this scheme further clarifies the specific construction of the lateral opening structure, which consists of a needle end clamp and a lateral groove formed on the side wall of the clamp. The lateral groove extends from the side of the needle end clamp to its end face, forming an open channel. When connecting the flat suture to the suture needle, the operator can directly insert one end of the flat suture into the needle end clamp from the side along its width direction, without the need for the cumbersome alignment and threading actions of traditional needle-suture connection. After the flat suture is inserted, radial pressure is applied to the needle end clamp using an external tool (e.g., needle holder), causing it to undergo elastic or plastic deformation. This deformation causes the previously open lateral groove to close, while the inner wall of the needle tail clamp exerts a strong clamping effect on the flat suture placed within, thus achieving a secure fixation. The technical benefits of this solution are as follows: First, the lateral groove design simplifies the assembly process of the flat suture. Compared to the traditional method of creating a circular end hole at the needle tail for axial threading, the lateral embedding operation is more direct and faster, reducing the complexity of preoperative preparation. Second, the clamping fixation method, especially for flat sutures, provides a more evenly distributed clamping force along its wide surface. This avoids stress concentration or twisting that may occur with flat sutures caused by traditional circular end holes, ensuring the reliability of the connection. Finally, the clamping state formed by the deformation of the needle tail clamp under external pressure is a stable mechanical lock that effectively prevents the suture from accidentally dislodging during suturing, ensuring the smooth progress of the surgery.

[0017] Furthermore, the diameter of the suture needle is smaller than the effective filling diameter formed by the flat suture due to folding or curling when it passes through human tissue and is under tension, so as to tightly fill the wound formed by the suture needle in the human tissue. Specifically, this design further defines the dimensional fit between the suture needle and the flat suture. The diameter of the suture needle is designed to be smaller than a dynamic parameter formed by the flat suture in actual use, namely the "effective filling diameter". This "effective filling diameter" refers to the fact that when the flat suture passes through the wound formed by the suture needle in the human tissue and is subjected to a certain suture tension, its flat, ribbon-like suture will naturally fold, curl, or bundle due to space constraints and tension, thereby forming an approximately cylindrical suture bundle. The cross-section occupied by this suture bundle in the wound can be equivalent to a circle with a specific diameter, which is the "effective filling diameter". The technical effect of this solution is understood to be to prevent leakage (or bleeding). When the suture needle passes through human tissue, it creates a wound with a diameter approximately equal to the diameter of the needle itself. After the needle passes through, the following flat suture, under tension, passes through this wound with its "effective filling diameter." Because the design ensures that the needle diameter is smaller than the suture's "effective filling diameter," the latter's cross-sectional size is actually larger than the size of the wound created by the former. As a result, the flat suture exerts a slight, continuous radial expansion and pressure on the wound wall as it passes through. This creates a tight, gapless fit between the suture and the wound wall, physically sealing potential leakage channels. Therefore, it effectively prevents blood or tissue fluid from seeping out along the interface between the needle hole and the suture, helping to maintain a clear surgical field and reduce postoperative bleeding.

[0018] Furthermore, the anti-slip structure on the surface of the suture needle body consists of grooves or raised textures distributed along the axial or circumferential direction of the needle body; and the surface of the suture needle body is coated with a medical-grade lubricating coating and an antibacterial coating. It can be understood that, firstly, regarding the anti-slip structure, whether grooves or raised textures, their essence is to increase the surface roughness by changing the macroscopic geometry of the needle body surface. When the surgeon uses instruments such as needle holders to grasp the needle body, a greater static friction is generated between the clamping surface of the instrument and these uneven textures. This increased friction can effectively prevent the suture needle from accidentally sliding axially or rotating radially during clamping and force application, thereby significantly improving the stability and accuracy of the surgical operation and reducing the risk of accidental injury to surrounding tissues due to instrument slippage. Secondly, regarding the surface coating, the medical-grade lubricating coating (such as medical silicone oil) can form a low-friction coefficient interface on the needle body surface. When the suture needle punctures and passes through tissue, this coating significantly reduces the frictional resistance between the needle body and the tissue. This makes the puncture process smoother, requiring less puncture force and thus reducing additional damage to the tissue such as dragging and tearing. Antimicrobial coatings (such as those containing silver ions or other antimicrobial agents) create an environment that inhibits microbial activity on and around the suture needle. As the suture needle passes through the tissue and is inserted into the suture, this coating effectively inhibits bacterial adhesion and reproduction within the needle and suture channel, thereby reducing the risk of postoperative wound infection.

[0019] Furthermore, the flat suture, as an optimized biomedical polymer material product, is made of medical-grade polyester fiber material with a width of 2mm to 8mm and a thickness of 0.35mm to 0.55mm. It is woven from a predetermined number of 150D polyester warp yarns and 100D polyester weft yarns using a plain weave. The surface of the flat suture is coated with a coating that shapes the suture, increases smoothness, reduces lint, or fills fiber gaps; this coating also contains an antibacterial agent or a hemostatic agent. It can be understood that the technical effect of this solution is to provide a suture with excellent overall performance: First, its flat, strip-like geometry (width much greater than thickness) provides a large contact area when in contact with tissue. According to the pressure principle (P = F / S), under the same knot tension (F), a larger contact area (S) significantly reduces the local pressure of the suture on the tissue. This effectively avoids the cutting or compressive damage to soft tissue that traditional circular sutures may cause (i.e., "strangulation" or "cutting effect"), promotes blood circulation and healing of the wound, and improves the patient's postoperative comfort.

[0020] Secondly, the specific material and structural combination (150D warp / 100D weft / plain weave) ensures that the suture has sufficient tensile strength to meet the mechanical requirements of gynecological surgery. Simultaneously, the polyester fiber material itself possesses good biocompatibility and chemical stability. The specific thickness range (0.35mm-0.55mm) and weave structure give the suture moderate flexibility and friction, making it easy to handle, securely knotted, and less prone to slippage. Finally, functional coatings further optimize product performance. Physically modified coatings make the suture surface smoother, reducing the chafing sensation and damage to the fiber structure when passing through tissue; while the addition of antibacterial or hemostatic coatings transforms the suture from a passive closing tool into a medical device with therapeutic support functions that can actively participate in preventing infection or promoting local hemostasis.

[0021] This invention discloses a method for pairing suture needles and sutures for gynecological suturing surgery, used for needle and suture pairing and connection. The technical solution of this method includes the following steps in a logically sequential order:

[0022] Step A1: For flat sutures with a preset width and thickness, analyze their effective filling diameter for human tissue under simulated actual suturing conditions and tension, and use this effective filling diameter parameter as the benchmark parameter for matching suture needle specifications. This step is the determination of the benchmark parameter and is the foundation of the entire methodology. It first clarifies that the object of treatment is a flat suture with a specific width and thickness. The core operation is not to directly use the static geometric dimensions of the flat suture, but to analyze its dynamic behavior under simulated actual suturing conditions and tension. When the flat suture is pulled through the channel formed by human tissue, due to the force, its flat strip-shaped cross-section will undergo deformation such as folding and curling, thus forming an approximately cylindrical cross-sectional shape that can effectively fill the channel. The equivalent diameter of this shape is defined as the "effective filling diameter". The purpose of this step is to determine this "effective filling diameter" value of a specific specification flat suture through experimental or computational analysis and establish it as the benchmark parameter for subsequent matching work.

[0023] Step A2: Based on the effective filling diameter reference parameter of the flat suture determined in Step A1, match the suture needle specifications so that the maximum diameter of the suture needle is smaller than the effective filling diameter of the flat suture. This ensures that during the suturing of human tissue, the flat suture can tightly fill the wound formed by the suture needle's insertion with its effective filling diameter, achieving a blood-proof effect. This step is the suture needle specification matching step based on the reference parameter. This step is the core of the design and selection, selecting the matching suture needle based on the "effective filling diameter" reference parameter determined in Step A1. The matching criterion is: the maximum diameter of the selected suture needle must be smaller than the effective filling diameter of the flat suture. This dimensional relationship is key to achieving specific technical objectives. The underlying logic is: when the suture needle passes through the tissue, it forms a wound with a diameter approximately equal to its own maximum diameter; subsequently, when the flat suture follows through this wound with its "effective filling diameter," because its effective diameter is larger than the wound diameter, the suture will closely adhere to the wound wall and even slightly expand radially, thus forming a tight physical filling of the wound.

[0024] Step A3: Select a suture needle with a lateral opening at the end, and insert one end of the flat suture laterally into the lateral opening at the end of the suture needle. Step A4: Apply radial pressure to the end of the suture needle to close the lateral opening and simultaneously clamp the flat suture inward. These two steps describe the physical assembly process of the scientifically matched needle and suture. Step A3 is to load the suture: Select a suture needle with a lateral opening at the end and conveniently insert one end of the flat suture into the opening from the side. Step A4 is to secure the suture: Apply radial pressure to the needle end with the inserted suture to close the lateral opening, thereby firmly clamping the flat suture inside.

[0025] More specifically, in the above-described method of needle and thread pairing and connection, step A1 further includes the following specific steps:

[0026] Step B1, Test System Construction and Benchmark Calibration. First, a fluid dynamics test system is constructed. This system includes a transparent test module with a precision-machined cylindrical test channel to simulate the wound formed by a suture needle in human tissue. The system also includes a closed-loop fluid circulation unit to drive a medical-grade, low-viscosity, incompressible inert liquid (e.g., medical-grade silicone oil) through the test channel at a constant low flow rate. High-precision differential pressure sensors are installed at both ends of the test channel to monitor the pressure drop of the liquid before and after flowing through the channel in real time. Benchmark calibration is required before testing the suture. First, with no objects in the test channel, the benchmark pressure drop is measured and recorded. Then, a set of rigid, smooth-surfaced cylindrical calibration rods with different and precisely known diameters (e.g., 0.30 mm, 0.35 mm, 0.40 mm, 0.45 mm, 0.50 mm, 0.55 mm, 0.60 mm) are sequentially placed at the center of the test channel. At a constant flow rate, the pressure drop caused by each calibration rod is measured individually. Using this data, a calibration curve or database of "obstacle diameter - pressure drop" is established. This curve reflects the unique pressure drop value corresponding to a cylindrical obstacle of known diameter in the current fluid system.

[0027] Step B2, Dynamic Testing of Flat Sutures. Remove the calibration rod and pass the flat suture to be tested (e.g., a suture with a width of 5 mm and a thickness of 0.35 mm) through the test channel. Both ends of the suture are connected to a tension control system that can accurately apply and provide feedback on tension values.

[0028] Step B3, Simulated Tension Loading and Data Acquisition. Activate the tension control system to apply one or more tension values ​​simulating common tension ranges in actual gynecological suturing procedures to the flat suture (e.g., applying tensions of 0.5N, 1.0N, and 1.5N sequentially). Under each tension condition, activate the fluid circulation unit and pull the suture uniformly through the test channel at a constant low speed (e.g., 10 mm / s). During this dynamic process, a differential pressure sensor continuously acquires and records the pressure generated as the fluid flows through the channel occupied by the suture.

[0029] Step B4, calculation and determination of the effective filling diameter. The stable pressure drop value collected in Step B3 under a specific tension is compared with the "obstacle diameter-pressure drop" calibration curve established in Step B1. The corresponding diameter value is found on the calibration curve. This diameter value is determined as the stable effective filling diameter of the flat suture under that specific tension due to deformation such as folding and curling. By testing data under different tensions, the characteristics of the suture's effective filling diameter changing with tension can be obtained. Finally, the effective filling diameter corresponding to the maximum possible clinical tension can be selected as the benchmark parameter for the paired suture needle specification.

[0030] After completing the above steps, proceed to step A2, the precise matching step for suture needles. Based on the effective filling diameter reference parameter determined in step B4, select the appropriate suture needle. For example, if the effective filling diameter of a certain specification of flat suture under maximum clinical tension is measured to be 0.52 mm, then a suture needle with a maximum diameter less than 0.52 mm should be selected, such as a 0.48 mm or 0.50 mm suture needle. This ensures that in actual suturing operations, the flat suture can tightly fill the wound created by the suture needle puncture with its effective filling diameter, achieving a reliable anti-bleeding effect.

[0031] The methods employed in steps B1 to B4 above are based on fundamental physical laws of controlled fluid dynamics. The aim is to transform a flexible, dynamic geometric parameter (effective filling diameter) that is difficult to measure directly into a stable physical quantity (pressure drop) that is easy to measure precisely, thereby achieving indirect but highly accurate quantitative analysis. Specifically, this principle is based on the fluid continuity equation (A1v1 = A2v2) and Bernoulli's principle: in a closed pipe system with a constant flow velocity, when fluid flows through an obstacle, its effective flow cross-sectional area decreases, inevitably leading to an increase in the local flow velocity in that region; according to Bernoulli's principle, the increase in velocity is accompanied by a significant decrease in static pressure. Crucially, this change in pressure drop has a precise and monotonic functional relationship with the degree of obstruction of the flow channel by the obstacle (i.e., its cross-sectional dimensions). Therefore, the core step of this method is first "calibration": by using a series of rigid calibration rods with precisely known diameters for testing, a benchmark calibration curve of "obstacle diameter - pressure drop" is systematically plotted and established. This curve forms the quantitative basis for subsequent measurements, acting as a precise dictionary that "translates" physical quantities (pressure drop) into geometric dimensions (diameter). Subsequently, when testing a flat suture under tension, although its dynamic cross-sectional shape is irregular due to folding and curling under tension, it still generates an objective and precisely measurable pressure drop in the fluid. This pressure drop accurately reflects the actual degree of obstruction to fluid flow by the suture under these dynamic conditions. Finally, by comparing this measured pressure drop value with a pre-established benchmark calibration curve, an equivalent diameter value can be derived through reverse analysis. This diameter value is determined as the effective filling diameter of the flat suture under these dynamic conditions, its physical meaning being: the diameter of an ideal rigid cylinder capable of producing the exact same fluid resistance effect. This method successfully avoids the difficulties of directly measuring the dynamic geometry of flexible bodies, achieving precise, non-destructive, and dynamic quantification of key pairing parameters.

[0032] It is understandable that the fluid dynamics-based measurement method used in steps B1 to B4 above offers both quantification and high precision. This method transforms an irregular, dynamic geometric parameter (effective filling diameter) that is difficult to measure directly into a physical quantity (pressure drop) that is easy to measure accurately. Through precise calibration, it enables quantification and high-precision measurement of the effective filling diameter, avoiding the subjective estimation errors present in traditional methods. Simultaneously, it offers dynamic simulation and realism. The method is performed under dynamic conditions simulating tension and suture movement, and the results more realistically reflect the behavior of the suture during actual tissue passage. Compared to static measurements, its data has greater clinical reference value. Furthermore, it enables non-contact, non-destructive measurement. The entire measurement process is completed through a fluid medium, avoiding direct hard contact between the measuring tool and the suture surface, thus preventing any damage to the suture's structure or surface coating and ensuring the integrity of the sample being measured. Furthermore, this method innovatively applies the measurement principles of fluid dynamics to the performance characterization of medical textiles, breaking through the technical path of traditional mechanical testing or optical observation, and providing a brand-new technical solution with industrial feasibility for analyzing the dynamic geometric characteristics of flexible wires in confined spaces.

[0033] This invention discloses a method for manufacturing a suture kit for gynecological suturing surgery. The core of this method lies in the precision processing of biomedical polymer materials for manufacturing flat sutures, and includes the following steps:

[0034] Step S1: Select polyester fiber filaments of specific specifications as warp and weft yarns, and independently preset and control the tension of each warp yarn in the warp yarn group to ensure uniform tension in subsequent processes. This step, involving raw material selection and tension control, is the source and foundation of the entire manufacturing process. First, select polyester fiber filaments of specific specifications as warp yarns (forming the skeleton for the length direction and strength of the stitching) and weft yarns (used to weave and fix the warp yarns into a ribbon structure). The selection of specific specifications is based on preset performance indicators such as strength, thickness, and flexibility required for the final product. The key technical point of this step is to independently preset and control the tension of each individual warp yarn in the warp yarn group. In narrow-ribbon weaving, especially when the number of warp yarns is large (e.g., 96) and the denier is fine, ensuring that the tension of each yarn remains consistent and appropriate throughout the entire process from being drawn from the yarn frame to entering the weaving area is a core prerequisite for guaranteeing the quality of the final product. Independent tension control (e.g., by configuring an independent tensioner for each yarn) avoids problems such as uneven fabric surface, width fluctuations, inconsistent internal stress, or decreased strength caused by uneven tension.

[0035] Step S2: The tension-controlled warp yarns are wound parallel to form a warp beam according to a predetermined arrangement density and sequence. The warp beam is then installed on a flat-head shuttleless loom. Subsequently, each warp yarn is passed sequentially through the heald shedding device and reed gaps of the loom according to a preset weaving structure. This step is the warp yarn preparation and loom setup, a preparatory process before weaving, and builds upon the tension control results of step S1. All independently tension-controlled warp yarns, while maintaining uniform tension, are wound parallel to the warp beam according to a predetermined arrangement density (determined by subsequent reeds) and sequence. The warp beam is then installed on the designated weaving equipment—a flat-head shuttleless loom. This type of machine is suitable for the stable and efficient production of narrow-ribbed fabrics. After being mounted, each warp yarn must be passed sequentially through the heald shedding device (e.g., healds) and reed gaps of the loom according to a preset weaving structure (e.g., a plain weave to obtain a smooth surface). The heald frame controls the up-and-down movement of the warp yarns to form the shed opening, while the density of the reed (e.g., 32 holes / inch) directly determines the warp density and width of the finished product.

[0036] Step S3: Start the flat-head shuttleless loom. Following the preset warp and weft yarn interlacing structure and weft density, the weft yarn is introduced and interlaced with the warp yarn group, continuously weaving to form a flat, strip-shaped seam base fabric with a predetermined width and thickness. This step is the weaving implementation step and the core link in the formation of the flat seam base fabric. After starting the flat-head shuttleless loom, the weft insertion mechanism (such as knitting needles) introduces the weft yarn into the warp opening formed by the healdrying device, and interlaces it with the warp yarn group according to a preset structure (such as plain weave). Simultaneously, the weft density (e.g., 67 yarns / inch), i.e., the number of weft yarns per unit length, is controlled by adjusting the loom parameters. In this process, the warp yarn specifications and quantity in step S1, the reed specifications in step S2, and the weft yarn specifications and density in step S3 all work together to ultimately continuously weave a flat, strip-shaped seam base fabric with a predetermined width (e.g., 5 mm) and thickness (e.g., 0.35 mm). This is a process of multi-parameter precision coordination, transforming linear raw materials into a two-dimensional planar product with specific geometric dimensions and internal structure.

[0037] Step S4, Heat Ironing and Shaping: This step is a crucial finishing process for the biomedical polymer material. The flat, ribbon-like suture base fabric is heat-ironed under preset high temperature and duration conditions to stabilize its flat shape, precisely control its dimensions, and improve its physical properties. This step is a finishing process following heat ironing and shaping, and is a key step in the final performance optimization of the woven base fabric. The suture base fabric is heat-treated under preset high temperature (e.g., approximately 200°C for polyester fibers) and duration (e.g., more than ten minutes). This specific heat treatment process is not conventional ironing; its purpose is threefold: First, to rearrange the polyester fiber macromolecular chains, stabilize its flat, ribbon-like shape, eliminate internal stress generated during weaving, and prevent curling or twisting of the finished product during use or storage. Second, to precisely control and solidify its final width and thickness dimensions through the heat shrinkage effect. Third, to improve its physical properties, especially to reduce its elongation (i.e., extensibility), making the suture less prone to stretching under stress.

[0038] Further, in step S1, the warp yarns are made of 150D polyester filaments, and the weft yarns are made of 100D polyester filaments. In step S2, the warp yarns pass through the gaps of the reed of a 32-hole / inch steel reed at a predetermined arrangement density, and the preset weaving structure is a plain weave. In step S3, the preset weft density is set to 60 to 70 yarns / inch, and the weft yarns are introduced through a No. 12 knitting needle. Through the combination of the above steps S1 to S3, a flat strip-shaped seam base fabric with a width of 4.8mm to 5.2mm and a thickness of 0.32mm to 0.38mm is woven. It can be understood that in this scheme, the final width of the flat seam is mainly determined by the total number of warp yarns and the arrangement density of the warp yarns, and the use of a 32-hole / inch steel reed provides a precise benchmark for the warp density. The thickness, tightness, and surface smoothness of flat sutures primarily depend on the denier (thickness) of the warp and weft yarns, their interlacing structure (plain weave is one of the tightest structures), and the density of the weft yarns. Setting the weft density within a relatively high range of 60-70 tails / inch and using size 12 knitting needles suitable for high-density weaving ensures that the weft yarns are tightly driven into the openings formed by the warp yarns, thus creating a fabric with controllable thickness, stable structure, and density with the 150D warp yarns. Therefore, by precisely combining and limiting core process parameters such as yarn specifications, key loom component models, and warp and weft densities, it is possible to ensure the stable and repeatable production of medical-grade flat suture products that meet narrow tolerance ranges (e.g., width 5mm ± 0.2mm, thickness 0.35mm ± 0.03mm) and specific physical property requirements (e.g., smoothness, strength) in industrial production, guaranteeing the uniformity of product quality.

[0039] Furthermore, the step of independently presetting and controlling the tension of each warp yarn in step S1 includes: passing each warp yarn through an independent tensioner, and applying a preset tension value to each warp yarn by adjusting the preset state of the tensioner. Specifically, the core of this method is to configure an independent tensioner for each warp yarn in the warp yarn group, and to apply a preset, independent tension value to each yarn by adjusting the force-applying element inside the tensioner. It can be understood that the technical effect of this solution is to ensure the uniformity and appropriateness of the warp yarn tension during the weaving process, thereby ensuring the quality of the final product. The reason is that when weaving narrow-strip fabrics composed of dozens or even hundreds of warp yarns, the consistency of the tension of all warp yarns is crucial. If the tension is uneven, warp yarns with excessive tension will bear too high a load, are prone to breakage during weaving, and may lead to uneven strength of the finished product; while warp yarns with insufficient tension will slack, causing defects such as wrinkles and loose threads on the fabric surface, and also causing uneven fabric edges (slack edges). By setting an independent, adjustable tensioner for each warp yarn, precise tension management can be achieved for each yarn, compensating for any slight differences that may exist between different yarn bobbins. This ensures that the same and appropriate tension is applied to each warp yarn throughout the entire weaving process, from the first to the last. This uniform tension is a prerequisite for forming a smooth, dense, and flawless fabric surface, and it is also the fundamental guarantee that the load is evenly distributed across all warp yarns when the finished product is under stress, thereby maximizing the overall tensile strength. Therefore, this independent and precise tension control method is a key technological guarantee for the production of high-quality, high-performance flat medical sutures.

[0040] Furthermore, before the heat treatment in step S4, the flat strip seam base fabric is pre-soaked in clean water. The preset high temperature for the heat treatment in step S4 is 190°C to 210°C, and the heat treatment duration is 10 to 20 minutes. After completing step S4, a coating containing antibacterial or hemostatic agents is applied to the surface of the heat-treated flat strip seam to promote shape setting, increase smoothness, reduce lint, fill fiber gaps, and promote the formation of the flat seam. It can be understood that the technical effect of this solution lies in comprehensively optimizing the physical properties, dimensional stability, and additional functions of the flat seam through a systematic finishing process. The reasons are as follows: First, the pre-soaking process in clean water. Water is a good heat conductor; pre-soaking the dry seam base fabric allows the fibers to absorb water evenly. When entering the high-temperature heat treatment zone later, the presence of water promotes faster and more even heat transfer to every part of the fabric and the interior of every fiber. This avoids the uneven heating and external heat distribution that can occur with dry ironing, laying the foundation for a uniform and consistent setting effect. Secondly, specific high-temperature, long-duration heat ironing. Polyester fibers are thermoplastic materials. Heating them to 190℃-210℃, close to their softening point, and maintaining this temperature for 10-20 minutes allows the molecular chains within the fibers sufficient energy and time to relax and rearrange. This process effectively eliminates internal stress accumulated during weaving due to tension, allowing the fabric to "memorize" its straight, flat shape in a tension-free state. The direct result is a significant improvement in the dimensional stability of the finished seam thread (less prone to curling and shrinkage), while its extensibility (elasticity) is reduced and stabilized, resulting in better knot stability and predictability during stitching and knotting. Thirdly, the final functional coating. After the seam thread base fabric has achieved excellent physical morphology and properties through heat setting, a coating is applied. This coating not only further enhances its surface smoothness and reduces lint to facilitate smooth passage through tissue, but also endows the suture with additional biological functions by carrying active ingredients such as antibacterial agents or hemostatic agents. In addition to fulfilling the basic task of tissue closure, it can also play a positive role in adjuvant treatment and prevention of complications.

[0041] More specifically, step S1 above also includes the following specific steps:

[0042] Step C1, the construction steps of the non-contact tension control system. The tensioner used to apply independent tension to each warp yarn is configured as a non-contact electromagnetic eddy current tension control system. This system equips each warp channel (e.g., 96 channels) with an independent tension control module. Each module specifically includes: a freely rotatable lightweight rotor made of a highly conductive, non-ferromagnetic material (e.g., industrial pure aluminum); a stator surrounding the rotor containing a controllable electromagnetic coil; and a microelectronic controller for precisely adjusting the current in the coil. In the system, each polyester warp yarn to be processed, after being drawn from its bobbin, bypasses the lightweight rotor of its corresponding module.

[0043] Step C2, System Integration and Tension Calibration. Integrate and install all the aforementioned non-contact tension control modules between the warp creel and the warping machine. Then perform system calibration: Under static or extremely low speed conditions, measure the actual tension value of the warp yarn using a high-precision tension sensor, and simultaneously record the control current value applied to the electromagnetic coil required to achieve that tension value. By measuring a series of different tension points, establish a precise digital mapping database of "control current - yarn tension" for the entire system.

[0044] Step C3 involves applying warp tension based on a dynamic profile during the warping process. During the warping process in step S2, instructions are sent from the central control system to the microelectronic controller of each tension control module. Unlike traditional methods that can only set a constant tension value, this method can apply a preset dynamic tension profile. Specifically, a reference tension value T1 is applied to the warp yarns in the central region constituting the main body of the seam (e.g., the middle 88 warp yarns). A tension value T2, slightly higher than the reference value, is applied to the warp yarns forming the two edges of the seam (e.g., the outermost 4 warp yarns on each side) (e.g., T2 = 1.1 * T1). This differentiated tension application allows for a tighter interweaving of the warp and weft yarns in the edge region of the seam during weaving, forming a natural, structurally reinforced, and dense selvage, which is crucial for preventing the edge fibers of flat seams from unraveling during use.

[0045] Step C4, subsequent weaving and finishing steps. The warp beam, wound with precise and dynamic tension control as described above, is used in subsequent steps S3 (weaving) and S4 (finishing). Due to the highly uniform tension of the input warp yarns and the reinforcement of the edges, the woven flat-stitched base fabric exhibits significant improvements in flatness, dimensional consistency, and edge structural integrity.

[0046] The method employed in steps C1 to C4 above applies Lenz's law of electromagnetic induction to micro-tension control in the manufacture of medical textiles (traditional mechanical tensioners rely on friction generated by physical contact to provide tension, which inherently suffers from unstable friction coefficients, easy wear, and damage to the yarn). The technical principle of this method is as follows: when the polyester warp yarn is pulled, causing the aluminum rotor wound around it to rotate, the conductive rotor cuts magnetic field lines in the static magnetic field generated by the stator. According to the principle of electromagnetic induction, an induced electromotive force is generated inside the rotor, forming a closed current, i.e., eddy current. According to Lenz's law, the magnetic field generated by the induced current (eddy current) always opposes the change in magnetic flux that caused the induced current. Specifically, the magnetic field generated by the eddy current interacts with the original magnetic field of the stator, producing an electromagnetic braking torque opposite to the direction of rotor rotation. This braking torque acts directly on the rotor, generating a smooth and continuous resistance to the movement of the warp yarn; this resistance is the tension applied to the warp yarn. Crucially, the magnitude of this braking torque is proportional to the current intensity in the stator's electromagnetic coil. Therefore, by precisely controlling the current in the input coil, the tension applied to the yarn can be precisely and steplessly adjusted. Since the entire process involves no physical contact, it overcomes all the drawbacks of traditional mechanical methods, providing a high-precision tension control solution for manufacturing high-quality flat sutures.

[0047] It is understandable that the technical effects of the methods used in steps C1 to C4 above include: First, it achieves extremely high tension uniformity and stability. Electromagnetic eddy current tension control is a purely non-contact action, fundamentally eliminating tension fluctuations and inconsistencies caused by wear, temperature and humidity changes, and oil adhesion of mechanical friction plates. Its output tension is smooth and without jitter, ensuring that each warp yarn bears a constant and consistent tension throughout the entire processing, thereby producing a stitching base fabric with no internal stress differences and an extremely flat surface. Second, it enables dynamically programmable tension profile control. This scheme realizes differentiated and programmed setting of warp tension for flat fabrics. By applying higher tension to the edge warp yarns, a dense, anti-unraveling edge can be directly formed inside the fabric structure. This "built-in" overlock structure is more robust and has better biocompatibility than subsequent hot-melt or coating overlock structures. Furthermore, it achieves zero damage to the yarn fibers. The non-contact nature avoids friction, compression, and wear on the polyester filaments from mechanical parts, maximizing the protection of the fiber's original strength and surface smoothness, and significantly reducing lint that may be generated in subsequent processes. Moreover, because this method is based on electrical signal control, its setting and response are precise, rapid, and highly repeatable. Once calibrated, the optimal tension parameters can be accurately reproduced in different batches of production, ensuring a high degree of consistency in product quality.

[0048] The technical advantages of the suture needle kit for gynecological suturing surgery of the present invention are as follows: Firstly, due to the blunt-tipped design, the suture needle can pass through the tissue fibers in a blunt dissection manner when puncturing fragile, blood-rich soft tissues such as the cervix during pregnancy, rather than directly severing the tissue and blood vessels as a sharp needle tip would. This directly results in a significant reduction in the risk of damage to local microvessels during suturing, thereby reducing intraoperative bleeding and protecting the integrity of the tissue structure. This is particularly beneficial for improving safety in surgeries with extremely high requirements for tissue trauma control, such as cervical cerclage. Simultaneously, the anti-slip structure on the needle surface provides a stable and reliable clamping interface for the needle holder. Therefore, in surgical scenarios involving deep locations such as the cervix, limited operating space, and slippery environments, the surgeon can more firmly control the posture and trajectory of the suture needle. This feature improves the precision and stability of surgical operations, effectively prevents accidental tissue damage caused by instrument slippage, and ensures the smooth progress of the suturing operation. Furthermore, due to the flat, band-like structure of the flat suture, the tension applied to the tissue after suturing and knotting can be distributed over a wider area. Compared to traditional sutures with the same tensile strength but a circular cross-section, its pressure per unit area on the tissue is significantly reduced. This physical characteristic effectively avoids the "cutting effect" or "strangulation effect" of the suture on soft tissue, especially in scenarios requiring cervical ligation to provide continuous support. It prevents the suture from embedding in or cutting cervical tissue, reducing the risk of postoperative complications such as tissue edema and ischemia, and improving patient comfort and long-term surgical success rates. Moreover, the lateral opening structure of the needle tail, combined with the flat suture, simplifies the needle-suture connection process, allowing the flat suture to be quickly and accurately assembled and clamped from the side. The clamping method applies a uniform clamping force across the entire width of the flat suture, resulting in a more secure connection compared to traditional needle holes, making it less prone to loosening or rotation during suturing. The combined features of this invention offer several advantages. First, they ensure a secure and reliable needle-suture connection, guaranteeing the continuity of the suturing process. Second, this efficient assembly method facilitates manufacturing. In summary, this invention organically combines features such as a blunt-tipped needle, an anti-slip needle body, a laterally opening needle tail, and a flat suture to synergistically address common technical problems in gynecological surgeries (especially cervical suturing), such as tissue fragility, high precision requirements, and the risk of sutures cutting into tissues. Ultimately, it achieves comprehensive technical benefits by improving surgical safety and precision while minimizing iatrogenic damage to patient tissues and improving suturing outcomes.

[0049] The technical advantages of the matching method for a suture kit for gynecological suturing surgery according to the present invention are as follows: First, step A1, by analyzing and determining the key parameter of the "effective filling diameter" of the flat suture, transforms the suture matching process from a fuzzy match relying on experience to a precise design based on objective data and mechanical behavior. This makes the functional performance of the suture combination (such as the anti-leakage effect) predictable, controllable, and repeatable, providing a scientific basis for manufacturing high-quality products with stable performance. Second, the core matching criterion established in step A2, that "the maximum diameter of the suture needle is smaller than the effective filling diameter of the flat suture," directly and predictably achieves the anti-leakage effect. In gynecological surgeries such as cervical cerclage, bleeding or amniotic fluid leakage at the needle hole is a concern. With the suture kit matched using this method, the wound formed by the needle is tightly "plugged" by the subsequently passed flat suture with a larger effective filling diameter during suturing. This physical tight filling effectively prevents blood or tissue fluid from seeping out from the gap between the needle hole and the suture, thus achieving the "anti-bleeding effect." This is of significant clinical importance for maintaining a clear surgical field, reducing the risk of postoperative infection, and protecting the integrity of the gestational sac. Finally, the needle-suture connection method in steps A3 and A4 (lateral embedding followed by radial pressure clamping) provides an efficient and secure solution for fixing flat sutures. The resulting technical benefits include ensuring the reliability of the needle-suture connection, preventing the suture from slipping off the needle tail due to stress during suturing, and improving production efficiency through its convenient assembly process. In summary, the needle-suture pairing method of this invention, through a scientific pairing step based on the "effective filling diameter" and an efficient physical connection step, ultimately enables the systematic and controllable manufacture of a gynecological suture kit with excellent anti-leakage properties. This method not only solves the problem of how to connect needles and sutures, but more importantly, it solves the technical problem of how to achieve optimal functional matching between needles and sutures to meet specific clinical needs (such as preventing bleeding in cervical suturing), thereby providing methodological assurance for improving surgical quality and patient safety.

[0050] The technical advantages of the manufacturing method of a suture kit for gynecological suturing surgery according to the present invention are mainly reflected in the deep customization and optimization of the performance of biomedical polymer materials: First, the combination of independent tension control in step S1 and parametric weaving in steps S2 and S3 ensures that the manufactured flat suture base fabric has a high degree of uniformity and consistency. Specifically, uniform tension ensures that the suture surface is flat and free of defects, and that each fiber inside is subjected to equal stress, without any local weak points. The direct technical effect of this is that each suture produced has stable and reliable tensile strength and a smooth surface, providing a basic guarantee for surgical safety and providing a high-quality base material for subsequent heat setting processes. Second, the complete weaving system constructed in steps S1 to S3, through the precise setting and combination of a series of variables such as yarn specifications, quantity, loom parameters, and weaving structure, achieves precise manufacturing and flexible adjustment of the width and thickness of the flat suture. The technical benefits are that it enables the stable and repeatable production of flat sutures that meet preset geometric tolerances, based on different clinical needs (such as the varying requirements for suture width during different stages of cervical cerclage), thus achieving standardized and serialized production. Furthermore, the specific high-temperature, long-duration heat-setting process in step S4 is crucial for achieving the high performance of the final product. Its technical benefits include: First, it achieves excellent suture morphological stability; the treated sutures are straight and do not curl, facilitating surgical manipulation and knotting, and ensuring their flattened function within the tissue. Second, it guarantees the accuracy and durability of suture dimensions; the heat setting "locks in" the width and thickness of the sutures, preventing dimensional changes during subsequent sterilization, packaging, storage, and use. Thirdly, the core mechanical properties of the suture are significantly optimized, particularly by reducing its elongation rate. For cervical cerclage, the aim is to provide a solid and stable "hoop" for the dysfunctional cervix to withstand the increasing pressure during pregnancy. If the suture elongation rate is too high, it will act like an elastic band, gradually stretching under continuous pressure, thus losing its effective support and leading to surgical failure. This step effectively reduces the elongation of the suture by eliminating internal stress and stabilizing the fiber molecular chain structure, resulting in less deformation under tension. In summary, the core technical effect achieved by the suture manufacturing method of this invention is: it can stably and efficiently produce a flat suture specifically suitable for demanding gynecological surgeries (especially cervical cerclage). This suture not only has a flat shape that disperses tissue pressure and prevents cutting damage, but more importantly, it possesses the low elongation rate and high morphological stability necessary for a supporting structure, thereby providing reliable and durable physical support for sutured tissues (such as the cervix), effectively meeting the needs of gynecological suturing surgery. Attached Figure Description

[0051] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0052] Figure 1 This is a schematic diagram of the needle and thread assembly (straight needle) of the present invention;

[0053] Figure 2 This is a structural diagram of the suture needle (straight needle) of the present invention;

[0054] Figure 3 This is a schematic diagram of the needle and thread assembly (curved needle) of the present invention;

[0055] Figure 4 This is a structural diagram of the suture needle (curved needle) of the present invention;

[0056] Figure 5 This is a schematic cross-sectional view of the tail end of the suture needle according to the present invention;

[0057] Figure 6 This is a partial schematic diagram of the invention regarding flat sutures;

[0058] Figure 7 This is a schematic cross-sectional view of the flat suture of the present invention.

[0059] Figure label:

[0060] 1. Suture needle, 2. Flat suture, 3. Lateral open structure, 31. Needle tail clamp, 32. Lateral groove. Detailed Implementation

[0061] To better understand the technical content of this invention, the invention will be described in more detail below with reference to the accompanying drawings and specific embodiments.

[0062] Example 1

[0063] This invention provides a suture needle and suture kit specifically designed for gynecological suturing procedures. (See reference...) Figures 1 to 7 The kit includes a suture needle 1 and a flat suture 2.

[0064] First, let's describe the suture needle 1 in this kit. (Refer to...) Figures 1 to 5The suture needle 1 comprises a needle tip, a needle body, and a needle tail. To meet the requirements for soft tissue protection in gynecological surgery, the needle tip of the suture needle 1 is blunt. Compared to a sharp needle tip, this blunt tip advances primarily by pushing and separating tissue fibers rather than making sharp cuts during puncture. This mechanism helps reduce cutting damage to tissues (especially blood vessels and nerves), thus preserving the integrity of the tissue structure and facilitating postoperative recovery.

[0065] To improve the stability of the surgical procedure, the surface of the suture needle 1 is provided with an anti-slip structure. In this embodiment, the anti-slip structure is an annular anti-slip groove with a depth of 0.1 mm, evenly distributed along the circumference of the needle body. When held by surgical instruments such as needle holders, the anti-slip grooves can form an effective mechanical engagement with the jaws of the needle holders, thereby providing increased gripping friction. This enhanced friction can prevent the needle body from accidentally sliding axially or rotating radially when subjected to puncture resistance or turning force, thus ensuring the surgeon's precise control over the needle body posture and puncture path during suturing. Figure 3 and Figure 4 The image shown is of a suture needle 1 in a curved shape. Figure 1 and Figure 2 The image shows a straight suture needle 1, whose anti-slip structure is designed based on the same principle as the technical effect it can achieve.

[0066] The needle 1 has a lateral opening structure 3 at its tail for connecting the flat suture 2. (See reference...) Figure 2 and Figure 4 The lateral opening structure 3 specifically includes a needle end clamp 31 and a lateral slot 32 extending from its side to its end face on the side wall of the needle end clamp 31. Before connection with the suture, the lateral slot 32 is in an open state, providing a convenient assembly entry. When connection is required, the operator can insert one end of the flat suture 2 into the lateral slot 32 from the side along its width direction and into the interior of the needle end clamp 31. Compared with the traditional perforated connection, this "lateral insertion" method eliminates the need for the time-consuming and visually demanding "threading" action, greatly simplifying the preoperative preparation process. Subsequently, by using external tools such as needle holders to apply radial pressure to a specific part of the needle end clamp 31, the needle end clamp 31 undergoes a preset plastic deformation, which causes the lateral slot 32 to close. At the same time, the inner wall of the needle end clamp 31 generates a large area clamping force on the wide surface of the flat suture 2 placed inside, thereby achieving a firm and fixed connection. This clamping method distributes force evenly across the wider surface of the suture, preventing stress concentration and damage to the suture fibers. The completed connection is shown in the reference image. Figure 1 , Figure 3 As shown.

[0067] Furthermore, to further optimize performance, the surface of the suture needle 1 can be sequentially coated with a medical-grade lubricating coating and an antibacterial coating. For example, the lubricating coating can be a medical-grade silicone oil coating, which reduces the coefficient of friction on the needle surface, thereby reducing puncture resistance, making the needle pass through the tissue more smoothly, and effectively reducing dragging and secondary damage to surrounding tissues. The antibacterial coating can be a silver ion-containing coating, which releases antibacterial silver ions on the wound surface after the suture needle passes through the tissue, inhibiting bacterial growth within the suture channel and thus reducing the risk of postoperative infection.

[0068] Next, the flat suture 2 in this kit will be explained. (Refer to...) Figure 6 and Figure 7 The flat suture 2 has a flat, strip-like structure with a defined width W and thickness T. It is made of medical-grade polyester fiber material. In this embodiment, its width W is set to 5 mm and its thickness T is set to 0.35 mm. This flat, strip-like geometry provides a much larger contact area with tissue than a circular suture with the same tensile strength. When knotted and tightened, the suture tension can be dispersed through this wider surface, effectively reducing the local pressure applied to the tissue. This avoids cutting or pressure necrosis of delicate soft tissue caused by the suture, the so-called "cheese suture effect," which has a positive effect on promoting wound healing and improving patient comfort. In other embodiments, the width W can be selected between 2 mm and 8 mm, and the thickness T can be selected between 0.35 mm and 0.55 mm to adapt to the suturing needs of different tissues.

[0069] Its internal structure is woven from warp and weft yarns using a plain weave. Specifically, the warp yarns can be 150D (denier) polyester filaments; for example, for a 5mm wide suture, the number of warp yarns can be 96. The weft yarns can be 100D polyester filaments. The plain weave structure is the most frequently interlaced structure of warp and weft yarns, giving the suture a compact structure and a relatively smooth surface, which helps reduce friction when passing through tissue. The surface of the flat suture 2 can be coated with a functional coating. One function of this coating is physical modification; for example, a Parylene coating can be used, which can uniformly coat the fiber surface, resulting in better suture shape shaping, increased surface smoothness, reduced fiber shedding, and filling the tiny gaps between fibers, reducing the capillary effect of the suture. Another function is to impart biological functions; for example, the coating can also contain antibacterial agents or hemostatic agents, allowing the suture to play an additional role in preventing infection or promoting local hemostasis while closing the wound.

[0070] A key design feature of this embodiment lies in the dimensional fit between the suture needle 1 and the flat suture 2, a fit designed to prevent leakage. It is important to understand that when the flat suture 2 passes through the wound formed by the needle and is subjected to tension, its strip-like structure naturally folds or curls due to space constraints, forming an equivalent, approximately circular filling cross-section. The diameter of this cross-section is the "effective filling diameter." This effective filling diameter is greater than its original thickness T, but much smaller than its original width W.

[0071] In this embodiment, for a flat suture 2 with a width of 5 mm and a thickness of 0.35 mm, experimental or simulation analysis shows that its effective filling diameter under typical suture tension is approximately 0.5 mm. Correspondingly, the maximum diameter of the suture needle 1 is designed to be 0.45 mm. Since the needle diameter (0.45 mm) is smaller than the effective filling diameter of the suture (0.5 mm), when the suture 2 passes through the tissue with the needle, it can tightly fill the wound formed by the needle with its effective filling diameter. Furthermore, the suture 2 exerts slight radial pressure on the wound wall, creating a tight interface between the suture and the tissue, thereby effectively sealing the potential leakage channel formed by needle puncture and preventing blood or tissue fluid from seeping along the suture.

[0072] This method of needle and thread pairing and connection first determines the effective filling diameter of a specific specification flat suture by analysis (step A1), then selects a suture needle with a smaller needle diameter based on the diameter (step A2), and finally completes the connection by lateral embedding (step A3) and clamping fixation (step A4) to form an integrated suture tool with anti-leakage function.

[0073] Example 2

[0074] This invention also provides a method for manufacturing the above-mentioned flat suture 2, the specific steps of which are as follows:

[0075] Step S1: Raw material preparation and tension control.

[0076] Polyester fiber filaments of specific specifications are selected as raw materials. In this embodiment, 150D polyester fiber filaments are selected as warp yarns, and 100D polyester fiber filaments are selected as weft yarns. For example, to manufacture a flat seam with a width of 5mm, 96 warp yarns are prepared, and the corresponding yarn bobbins are wound separately. The 96 warp yarn bobbins are hung on the warp yarn rack. The key to this step is to ensure that each warp yarn passes through a tensioner independently. A preset and independent tension value is applied to each warp yarn by adjusting the force-applying element in the tensioner (optionally, for example, in this embodiment, a tensioner with a built-in elastic force-applying element can be used; for 150D warp yarns, a spring sheet can be set for the tensioner). The purpose of this step is to ensure that all 96 warp yarns maintain a consistent and appropriate tension in the subsequent winding and weaving processes. This refined tension uniformity control is the basis for preventing defects such as loose edges and uneven weaving during the weaving process, and for ensuring that the final finished tape has a flat surface, stable width, and uniform strength.

[0077] Step S2, warping and pre-weaving preparation.

[0078] Ninety-six warp yarns, each with independently controlled tension, are arranged in parallel and evenly wound onto a warp beam under the action of a warping machine. The wound warp beam is then installed onto the back crease of a flat-head shuttleless loom. Following a preset plain weave structure, each warp yarn is carefully straightened and sequentially passed through the healds of the loom's healdry control device and the gaps between the reed teeth. In this embodiment, a reed with 32 holes / inch is selected to achieve the predetermined warp yarn arrangement density. The choice of reed type directly determines the number of warp yarns accommodated per unit width and is one of the key process parameters for accurately controlling the finished width.

[0079] Step S3, weaving.

[0080] The 100D weft yarn is introduced into the weft insertion mechanism of the loom. To accommodate the requirements of fine weft yarn and high weft density, a No. 12 needle can be selected. This type of needle has a smaller needle hole that matches the yarn used, helps to maintain the stability of the weft yarn during the weft insertion process, and enables a tighter weft yarn arrangement, thereby forming a fabric with a tight texture and stable structure.

[0081] According to product design requirements, the weft density is set to approximately 67 yarns / inch by adjusting the weft density control mechanism (such as the weft density gear) on the loom. The flat-head shuttleless loom is started and continuously woven according to a plain weave pattern to form a flat, strip-shaped seam base fabric. During the weaving process, the width and thickness of the woven base fabric are continuously monitored online or offline to ensure that its dimensions meet preset standards (e.g., width 5mm ± 0.2mm, thickness 0.35mm ± 0.03mm), and stable loom operating parameters are recorded. The purpose of this is to establish standardized production process procedures to guide quality control in large-scale production and ensure batch-to-batch product consistency.

[0082] Step S4, post-processing.

[0083] This step includes pretreatment, heat setting, and coating treatment, aiming to further optimize the physical properties and functions of the stitching base fabric. First, the woven flat strip stitching base fabric can be pre-soaked in clean water. The purpose of this step is to allow the fibers to absorb water evenly, utilizing water as a good conductor of heat to facilitate rapid and uniform heat transfer within the fabric, thereby avoiding uneven heating that may occur with dry heat treatment.

[0084] Subsequently, heat setting is performed. The pre-soaked suture fabric is placed in a heat setting device, and the heat setting temperature is set at 200℃ and maintained at this temperature for approximately 15 minutes. This high-temperature, long-duration treatment is a crucial step in achieving the final performance of the product. It effectively eliminates the internal stress accumulated in the polyester fibers during spinning and weaving, allowing the fiber molecular chains to rearrange and stabilize. The technical effects are twofold: firstly, it stabilizes the flat shape of the suture, i.e., "setting," preventing curling or twisting during use; secondly, it significantly reduces its elongation under tension, improving dimensional stability and ensuring the strength of the seam.

[0085] Finally, a coating is applied to the surface of the flat suture after heat pressing and shaping. The coating material and function are as described in Example 1, and can be selectively applied according to specific needs to further improve the smoothness, morphological stability, and biological function of the suture.

[0086] After completing all the above steps, you can obtain a finished flat medical suture with stable performance and accurate dimensions.

[0087] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A suture needle and thread kit for gynecological suturing surgery, characterized in that: Includes suture needles (1) and flat sutures (2); The suture needle (1) includes a needle tip, a needle body and a needle tail. The needle tip has a blunt tip structure, the needle body surface is provided with an anti-slip structure, and the side to end face of the needle tail forms a lateral opening structure (3). The flat suture (2) has a flat strip structure, a preset width-to-thickness ratio, and a smooth surface; Wherein, one end of the flat suture (2) is laterally embedded and fixedly connected to the lateral opening structure (3) of the needle tail of the suture needle (1). The flat suture (2) is made of medical grade polyester fiber material, with a width of 2 mm to 8 mm and a thickness of 0.35 mm to 0.55 mm, and is woven by plain weave with a predetermined number of 150D polyester fiber warp yarns and 100D polyester fiber weft yarns. The surface of the flat suture (2) is coated with a coating that shapes the suture, increases smoothness, reduces lint, or fills the gaps between fibers, and the coating also contains an antibacterial agent or a hemostatic agent.

2. The suture needle and thread kit for gynecological suturing surgery according to claim 1, characterized in that, The lateral opening structure (3) includes a needle tail clamp (31) and a lateral slot (32) formed on the side to the end face of the needle tail clamp (31). The flat suture (2) is laterally embedded into the needle tail clip (31) through the lateral groove (32); After being deformed by external pressure, the needle tail clamp (31) closes the lateral groove (32) and clamps and fixes the flat suture (2).

3. The suture needle and thread kit for gynecological suturing surgery according to claim 2, characterized in that, The diameter of the suture needle (1) is smaller than the effective filling diameter formed by the flat suture (2) when it passes through human tissue and is under tension due to folding or curling, so as to tightly fill the wound formed by the suture needle (1) in human tissue through the flat suture (2).

4. The suture needle and thread kit for gynecological suturing surgery according to claim 1, characterized in that, The anti-slip structure on the surface of the suture needle (1) is a groove or raised texture distributed along the axial or circumferential direction of the needle body; Furthermore, the surface of the suture needle (1) is coated with a medical-grade lubricating coating and an antibacterial coating.

5. A method for manufacturing a suture needle and thread kit for gynecological suturing surgery according to claim 1, used for manufacturing flat sutures, characterized in that, Includes the following steps: Step S1: Select polyester fiber filaments of specific specifications as warp yarns and weft yarns respectively, and independently preset and control the tension of each warp yarn in the warp yarn group to ensure that the tension is uniform in subsequent processes. Step S2: The warp yarns, which have undergone tension control, are wound in parallel to form a warp beam according to a predetermined arrangement density and sequence. The warp beam is then installed on a flat-head shuttleless loom. Subsequently, each warp yarn is passed through the heald sheath opening device and reed gap of the loom in sequence according to the preset weaving structure. Step S3: Start the flat-head shuttleless loom, and according to the preset warp and weft yarn interlacing structure and weft yarn density, introduce the weft yarn and interlace it with the warp yarn group to continuously weave and form a flat strip-shaped stitched base fabric with a predetermined width and thickness. Step S4, Heat Ironing and Shaping: The flat strip-shaped sewn fabric is heat ironed under preset high temperature and duration conditions to stabilize its flat shape, accurately control its size and improve its physical properties.

6. The method for manufacturing the suture needle and thread kit for gynecological suturing surgery according to claim 5, characterized in that: In step S1, the warp yarns are made of 150D polyester filaments, and the weft yarns are made of 100D polyester filaments. In step S2, the warp yarns are passed through the gaps of the reeds of a steel reed with a pre-determined arrangement density of 32 holes / inch. The pre-determined weaving structure is a plain weave. In step S3, the pre-determined weft density is set to 60 to 70 tails / inch, and the weft yarns are introduced through a No. 12 knitting needle. Through the combination of the above steps S1 to S3, a flat strip-shaped stitched base fabric with a width of 4.8 mm to 5.2 mm and a thickness of 0.32 mm to 0.38 mm is woven.

7. The method for manufacturing the suture needle and thread kit for gynecological suturing surgery according to claim 5, characterized in that, The step of independently presetting and controlling the tension of each warp yarn in step S1 includes: passing each warp yarn through an independent tensioner and applying a preset tension value to each warp yarn by adjusting the tensioner.

8. The method for manufacturing the suture needle and thread kit for gynecological suturing surgery according to claim 5, characterized in that: Before performing the heat ironing process in step S4, the flat strip stitching base fabric is pre-soaked in clean water. The preset high temperature for the heat ironing process in step S4 is 190°C to 210°C, and the ironing duration is 10 to 20 minutes. After completing step S4, the surface of the flat strip suture that has been heat-ironed and shaped is coated with a coating that promotes the shaping of the flat suture, increases smoothness, reduces lint, fills the gaps between fibers, and contains an antibacterial agent or hemostatic agent.

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