Surgical operation suture line easy to knot and use method of surgical operation suture line easy to knot

Abstract

The invention discloses an easy-to-knot suture line for surgical operation. The easy-to-knot suture line comprises a main line body, the two ends of the main wire body are provided with preset fracture parts, and the ends, away from the main wire body, of the preset fracture parts are provided with extension wire bodies. The diameter of the preset fracture part is smaller than that of the corresponding main line body and extension line body, and the joint is in arc transition; and an annular concave part is arranged at the middle end of the preset fracture part. By arranging the preset fracture part, the knotting force depending on subjective experience is converted into an objective physical threshold value; when the tensioning force reaches a preset safe effective value, the preset fracture part is fractured, force application is automatically stopped, and the risks of tissue avascular necrosis caused by too tight ligation or bleeding and cracking caused by too loose ligation are avoided.

Description

Technical Field

[0001] This invention relates to the field of medical accessory technology, specifically to a surgical suture that is easy to knot and its method of use. Background Technology

[0002] The surgical knot is a key technique for suturing in surgical procedures, a reinforced variant of the square knot. Its core characteristic is that when tying the first single knot, the suture is wrapped twice to increase friction and prevent it from loosening due to tissue tension or a smooth suture before the second knot is tied. Subsequently, the second knot is wrapped once in the opposite direction and tightened, forming a secure and slip-resistant square knot. This technique is particularly suitable for tissues with high tension or when using smooth, monofilament synthetic sutures, ensuring reliable ligation and representing a fundamental skill that surgeons must master.

[0003] In surgical procedures, suturing and knotting are two fundamental and crucial operations. The tightness of the knot directly affects the success of the surgery and the patient's recovery. If the knot is too loose, it may lead to poor wound closure, bleeding, anastomotic leakage, or hernia formation; if the knot is too tight, it may cause local tissue ischemia, necrosis, and increased pain, and in severe cases, it may even cause the suture to cut into the tissue.

[0004] Currently, the tightness of ligation relies entirely on the surgeon's personal experience, feel, and visual judgment, lacking objective, quantifiable, and consistent standards. This subjectivity is particularly risky in situations where visibility and tactile feedback are limited, such as high-intensity sutures, the use of smooth sutures, or laparoscopic surgery. Although various knot-tying training tools and methods exist, there is still no mature product integrated into the suture itself that can automatically limit and indicate safe ligation force during surgery.

[0005] Therefore, there is an urgent need for a surgical suturing device and method that can transform the ligation force from subjective experience into an objective physical standard and provide clear operational feedback. Summary of the Invention

[0006] The present invention aims to solve the technical problem mentioned in the background art above, that the sutures in the prior art cannot provide doctors with feedback on the tightness of the ligation or physical limitations, and provides a surgical suture that is easy to knot and its method of use.

[0007] To solve the above-mentioned technical problems, the technical solution provided by the present invention is: a surgical suture that is easy to knot, comprising a main suture body; both ends of the main suture body are provided with pre-set fracture portions, and the end of the pre-set fracture portion away from the main suture body is provided with an extension suture body; The diameter of the pre-set fracture section is smaller than the diameter of the corresponding main body and extension body, and the joint is rounded. The pre-set fracture section has an annular recess at its middle end.

[0008] Furthermore, the main body, the pre-set fracture section, and the extension body are all made of the same material and are integrally formed; the pre-set fracture section is a narrow neck section with a smaller overall diameter formed by the main body and the extension body.

[0009] Furthermore, the integral molding of the main body, the pre-set fracture portion, and the extension body is achieved through a single extrusion molding process, wherein the pre-set fracture portion is formed by controlling the flow channel change of the extrusion die.

[0010] Furthermore, the length and diameter of the pre-set fracture section are set according to the maximum force of knotting the main body, and it automatically breaks when the tension reaches the predetermined knotting tension.

[0011] Furthermore, the annular recess is coated with a colored marking layer; the colored marking layer is formed using a biocompatible medical colorant.

[0012] Furthermore, after all the pre-set fracture portions have broken, the remaining main thread is used as a regular suture.

[0013] Furthermore, it includes the following steps: S1: The main suture passes through the tissue to be sutured; S2: Perform a knotting operation, during which at least one of the extension lines is held and tightened by hand or instrument; S3: Continuously apply tension until the pre-set fracture part connected to the taut extension line breaks at its annular recess. S4: Treat the fracture as a signal that the ligation force has reached the target, and complete the current knot.

[0014] The advantages of this invention compared to the prior art are: 1. By setting a preset fracture point, the knotting force that relies on subjective experience is transformed into an objective physical threshold. When the tension reaches the preset safe and effective value, the preset fracture point breaks, automatically stopping the application of force, thus avoiding the risk of tissue ischemia and necrosis due to excessively tight ligation or bleeding and cracking due to excessively loose ligation. 2. The pre-set fracture section adopts a narrow neck section with a gradually changing diameter and a rounded transition at the joint, which can effectively reduce stress concentration and ensure that the fracture occurs at the preset annular concave position, thereby improving the stability and consistency of the fracture force value. The annular concave part, as a precisely introduced weak point, further controls the starting position of the fracture and the required force value.

[0015] 3. The annular recess and its colored marking layer provide doctors with clear visual and tactile positioning; when tying a knot, doctors only need to keep pulling the extension line until it breaks, and at the moment of breakage, they will get a clear physical tactile feedback that "the force has reached the standard", without having to try repeatedly, which simplifies the operation. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of a surgical suture that is easy to knot.

[0017] Figure 2 This is a schematic diagram of the pre-fractured section structure of a surgical suture that is easy to knot.

[0018] As shown in the figure: 1. Main body, 2. Pre-set fracture section, 3. Extension body, 4. Annular recess. Detailed Implementation

[0019] The present invention will now be described in further detail with reference to the accompanying drawings. Example

[0020] Combined with appendix Figure 1 , 2 A surgical suture that is easy to knot, which is made of biocompatible monofilament polypropylene material through an integrated precision extrusion molding process; The suture mainly consists of a three-section structure: the main suture body 1 located in the middle and mainly used for suturing, the extension suture bodies 3 located at both ends, and the pre-set fracture part 2 connecting the main suture body 1 and the extension suture body 3; it should be noted that the whole is divided into three parts for ease of explanation, but in actual processing, the three parts are made of the same material and are molded as one piece. Specifically: The main suture body 1, as the core part that penetrates and bears the tissue tension, comes in various models and sizes according to actual needs. It has a smooth surface and is flexible enough for suturing operations; one end of it is connected to the suture needle. The pre-set fracture section 2 is a precisely designed narrow neck structure. The diameter of this section is uniformly reduced to 50%-60% of the main suture body 1, and the length is about 5-8mm. If it is too short, it will cause extreme stress concentration, which will make the fracture process brittle and unpredictable, and the fluctuation range of the fracture force value will be larger. Moreover, it is difficult for doctors to accurately grasp a very short weak point when wearing gloves and with blood in their field of vision. The tactile feedback is also unclear. In addition, it may break prematurely. If it is too long, the fracture initiation point will not be unique, which may lead to the fracture at an unexpected location. In addition, when the weak area is subjected to force, it may undergo obvious plastic tensile deformation instead of clear brittle fracture, and the instantaneous feedback is unclear, so the doctor cannot obtain a clear completion signal. Most importantly, when tying a surgical knot, if the pre-set fracture section is too long, there is a high probability that it will be wrapped inside the knot loop. Once part of its length participates in the formation of the knot, it may cause the fracture point to occur inside the knot, resulting in knot failure or loosening, with serious and dangerous consequences. The connection between the pre-set fracture section 2 and the main body 1 and the extension body 3 is made by using a large arc to make a smooth transition, so as to optimize stress transmission and avoid unexpected stress concentration. In addition, at the axial midpoint of the pre-set fracture part 2, there is an annular recess 4, which can be formed by laser grooving or other methods. The diameter of the extension suture 3 is restored to be consistent with that of the main suture 1; the length must ensure that the doctor has sufficient length of suture to pinch or hold with tweezers to complete at least one standard surgical knot and facilitate the application of force to break the pre-prepared fracture 2.

[0021] The tensile breaking force of the annular recess 4 in the middle of each pre-fractured part 2 is preset within a target range. The upper limit of this target range is lower than the critical force value that causes ischemic damage to the tissue, and the lower limit is higher than the minimum force value required to ensure effective closure of the tissue. The design process for the fracture force value of the annular recess 4 is as follows: 1. First, obtain the minimum effective closing force; S1: Use standard sutures to tie knots on isolated or living animal tissue and connect a tension sensor; S2: Gradually increase the knotting force while observing: (1) The wound closure condition, until there is no gap; (2) Hemostatic effect; (3) The sealing of the knotted position (e.g., blood vessels or simulated pipes, measuring the leakage pressure); S3: The minimum tension required to achieve the above clinical goals, plus a safety factor such as 1.2, to obtain the required value; 2. Obtain the critical force for tissue damage; S1: On the same model as above, continue to apply knotting force until clear damage is observed; clear damage can be observed in several ways, such as interruption of blood supply, tissue being cut by sutures or visible ischemic pallor; or ultrasound showing complete disappearance of local blood flow signal; S2: The maximum tensile force when clear signs of damage appear, minus a safety factor such as 0.9, to obtain the critical force for tissue damage; 3. Through a series of experiments, the design range of tensile strength of the annular recess 4 is obtained; within this range, a relatively safe upper-middle value is selected, and then the size range of the annular recess 4 is calculated accordingly based on the different materials and structures of the sutures.

[0022] The steps for using easy-knot sutures are as follows: S1: Main suture 1 passes through the tissue to be sutured; S2: Perform a knotting operation, during which at least one of the extension lines 3 is held and tightened by hand or instrument; S3: Continuously apply tension until the pre-set fracture part 2 connected to the taut extension line 3 breaks at its annular recess 4; S4: Treat the fracture as a signal that the ligation force has reached the target, and complete the current knot.

[0023] In addition, if a situation arises where more force than usual is required to tie a knot, or if the doctor lacks sufficient experience, the pre-cut fracture section 2 can be broken first, and the remaining part can be used normally as the original suture.

[0024] Example 2: In another embodiment, the annular recess 4 is coated with a colored marking layer; the colored marking layer is formed using a biocompatible medical colorant; the colorant is non-cytotoxic, non-sensitizing, non-genotoxic, chemically stable, and will not decompose into harmful substances in the body; it should be noted that the coating must be very thin, only needing to serve a warning function; The colored marking layer significantly improves the product's ease of use and safety, allowing doctors to quickly and accurately identify the location that needs to be broken in a blood-stained field of vision; in addition, once the two pre-made fracture sections are broken in advance, the main suture body 1 can be used as a regular suture.

[0025] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A surgical suture that is easy to knot, comprising a main suture body (1); characterized in that: Both ends of the main body (1) are provided with pre-set fracture parts (2), and the end of the pre-set fracture part (2) away from the main body (1) is provided with an extension body (3). The diameter of the pre-set fracture part (2) is smaller than the diameter of the corresponding main body (1) and extension body (3), and the joint is a rounded transition. The pre-set fracture section (2) has an annular recess (4) at its middle end.

2. The surgical suture that is easy to knot according to claim 1, characterized in that: The main body (1), the pre-set fracture section (2), and the extension body (3) are all made of the same material and are integrally formed; the pre-set fracture section (2) is a narrow neck section with a smaller overall diameter formed by the main body (1) and the extension body (3).

3. The surgical suture that is easy to knot according to claim 1, characterized in that: The integral molding of the main body (1), the pre-set fracture part (2), and the extension body (3) is achieved by a single extrusion molding process, wherein the pre-set fracture part (2) is formed by controlling the flow channel change of the extrusion die.

4. The surgical suture that is easy to knot according to claim 1, characterized in that: The length and diameter of the pre-set fracture section (2) are set according to the maximum force of knotting the main body (1), and it will automatically break when the tension reaches the predetermined knotting tension.

5. The surgical suture that is easy to knot according to claim 1, characterized in that: The annular recess (4) is coated with a colored marking layer; the colored marking layer is formed using a biocompatible medical colorant.

6. The surgical suture that is easy to knot according to claim 1, characterized in that: After all the pre-set fractured parts (2) are broken, the remaining main thread (1) is used as a regular suture.

7. The surgical suture that is easy to knot according to claim 1, characterized in that: The steps for using easy-knot sutures are as follows: S1: The main thread (1) passes through the tissue to be sutured; S2: Perform a knotting operation, during which at least one of the extension lines is held and tightened by hand or instrument (3). S3: Continue to apply tension until the pre-set fracture part (2) connected to the taut extension line (3) breaks at its annular recess (4); S4: Treat the fracture as a signal that the ligation force has reached the target, and complete the current knot.

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