Barb knotless suture with compound cutting structure

Abstract

The utility model discloses a barb is exempted from to tie up suture with compound cutting structure, including suture body, barb, shallow layer score, barb is formed through double angle cutting process, and first cutting angle is 123 DEG~136 DEG, and second cutting angle is 5 DEG~10 DEG, and cutting radial depth is 0.052~0.069mm, and line diameter retention rate is not less than 85%, and cutting axial length is 0.258~0.392mm, shallow layer score is located on the suture body of barb and suture body contact area's suture body. The utility model not only can minimize cutting depth, retain suture strength, make in clinical use process more have safety reliability, and can enhance the separation efficiency of barb when reverse stretching, avoid barb closing phenomenon, promote suture grip force.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field especially, it is further for a barb knot-free suture thread for surgical suture, a kind of suture thread structure that barb gripping force is enhanced and separation performance is optimized by composite cutting process, specifically related to a barb knot-free suture thread with composite cutting structure. BACKGROUND

[0002] Suture thread is important medical instrument for closing wound, connecting tissue or ligating blood vessel in surgical operation. According to material characteristics, suture thread can be divided into absorbable thread and non-absorbable thread. The material of absorbable thread has polydioxanone (PDO), polylactic acid (PLA) etc., can be gradually degraded and absorbed in vivo, and is suitable for internal tissue suture;The material of non-absorbable thread has polypropylene (PP), polyester (PET) etc., needs to be removed after operation, and is suitable for skin surface suture.

[0003] Traditional suture thread needs to be fixed by knotting, and operation is complex and wound cracking is caused by knot buckle loosening. The emergence of barb suture thread solves this problem, which realizes self-fixing by cutting barb on the surface of thread and using the friction force between barb and tissue, so as to improve operation efficiency and reduce local stress concentration.

[0004] The existing knot-free suture thread is generally realized by uniformly distributing barbs on the thread body, but the barb structure is basically single-angle cutting, forming barb, and according to barb interval, it is divided into one-way and two-way barb thread, which changes the concept of traditional suture needing knotting, is convenient to use, saves trouble and improves operation efficiency.

[0005] The barb structure seen before is to uniformly cut many fishbone-shaped barbs on smooth cylindrical suture thread, which is distributed in 360° three-dimensional spiral along axial direction, one-way barb has initial segment, barb interval and end (with tail ring), two-way barb has initial segment, barb interval, middle end, barb interval and end, which is symmetrically arranged from middle point of suture thread to both sides, and each end of suture thread is connected with a suture needle, and the suture needle is dropped from middle of wound during suture, and two needles are sutured and pulled tight to both sides respectively, and after finishing, suture thread is cut off, and knotting is not needed.

[0006] Because barbed sutures are made by cutting a single strand of PDO suture, the suture diameter is reduced, resulting in lower breaking strength and a shorter degradation period. Different cutting methods create different barbs. To maintain the strength required for wound healing, barbs need to be formed while ensuring the suture's strength, allowing the suture to hold the tissue as it passes through. However, currently available barbed sutures are cut at a single angle. This cutting method easily damages the suture, significantly reducing its strength, and the resulting barbs have weak holding power. In clinical use, although barbed sutures are called knot-free sutures, doctors generally still use knotting, thus negating the value of the barbed structure. The barbed suture can only tighten in one direction and cannot retract, thus increasing the difficulty of the surgery.

[0007] In summary, existing barbed sutures still have the following defects: excessive cutting depth leads to a significant reduction in suture strength; the barbs are too tightly bonded to the suture, making it difficult to separate effectively when stretched in the opposite direction, resulting in insufficient gripping force, and knotting is still required. Utility Model Content

[0008] This invention aims to solve the aforementioned problems and improve the clinical performance of barbed sutures through a dual-angle cutting process and a shallow scoring design on the suture body. The specific technical solution adopted by this invention is as follows:

[0009] A barbed, knot-free suture with a composite cutting structure includes a suture body, barbs, and shallow notches. The barbs are formed by a dual-angle cutting process, with a first cutting angle of 123°–136°, a second cutting angle of 5°–10°, a radial cutting depth of 0.052–0.069 mm, a wire diameter retention rate of not less than 85%, and a cutting axial length of 0.258–0.392 mm. The shallow notches are located on the suture body in the contact area between the barbs and the suture body.

[0010] The first cutting angle is the obtuse angle between the first cutting line and the edge of the suture body, viewed from the axial section angle. The second cutting angle is the acute angle between the second cutting line and the edge of the suture body. The radial cutting depth includes the radial cutting depth formed by the first and second cutting lines. The wire diameter retention rate is the wire diameter of the uncut portion of the suture body divided by the wire diameter of the suture body itself. The axial cutting length includes the axial cutting length formed by the first and second cutting lines. After the double-angle cutting process, a contact area is formed when the barb closes with the suture body. Shallow notches are formed on the suture body in this area.

[0011] In some specific implementations, the first cutting angle is 132°.

[0012] In some specific implementations, the second cutting angle is 8°.

[0013] In some specific embodiments, the depth of the shallow scoring is 5% to 15% of the diameter of the suture body.

[0014] Furthermore, the depth of the shallow indentation is 6.93% to 12.13% of the diameter of the suture body.

[0015] Furthermore, the shape of the shallow grooves is one of the following: wavy, sawtooth, zigzag, or spiral.

[0016] In some specific implementations, the axial spacing of the barbs is 0.56 to 0.64 mm.

[0017] Optionally, the barbs are distributed along the suture direction, and the lines connecting the barbs form one or more straight lines parallel to the suture axis on the suture body.

[0018] The aforementioned shallow indentations were observed using the plane formed by the symmetry line of the barb and the suture axis as a cross section.

[0019] The aforementioned shallow indentations were observed using the plane formed by the symmetry line of the barb and the suture axis as a cross section.

[0020] This invention can be achieved using an automatic barbed thread cutting machine. The blade is driven by a pneumatic transmission device to cut the PDO single-strand suture by adjusting the blade's trajectory according to the required angle and length.

[0021] The technical solution of this utility model includes the following features:

[0022] Dual-angle cutting process: The first cutting angle (123°~136°) and the second cutting angle (5°~10°) are combined to form an outwardly expanding barbed structure;

[0023] Shallow scoring on the suture body: In the area where the barb contacts the suture body, shallow scoring is formed by laser or mechanical cutting. The scoring depth is 5% to 15% of the suture diameter, and the shape is one of the following: wavy, serrated, zigzag, or spiral.

[0024] Dynamic separation mechanism: The scoring structure increases the unevenness of contact between the barb and the suture body, which, under the action of wound tissue, promotes the separation of the barb and the suture body, forming an effective grip.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] Minimizing the cutting depth preserves suture strength, making it safer and more reliable in clinical use; it enhances the separation efficiency of barbs when stretched in the opposite direction, avoids barb closure, and improves suture grip.

[0027] The following will further explain the concept, specific structure and technical effects of this utility model in conjunction with the accompanying drawings, so as to fully understand the purpose, features and effects of this utility model. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of a suture structure cut at a single angle.

[0029] Figure 2 This is a schematic diagram of a double-angle cut suture structure.

[0030] Figure 3 This is a schematic diagram of a shallow, wavy suture structure.

[0031] Figure 4 This is a schematic diagram of a shallow, serrated suture structure.

[0032] Figure 5 This is a schematic diagram illustrating the first and second cutting angles.

[0033] The markings in the diagram are as follows: 1. Thread body; 2. Barb; 3. Shallow scoring; 4. First cutting line; 5. Second cutting line; 6. Cutting radial depth; a. First cutting angle; b. Second cutting angle. Detailed Implementation

[0034] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0035] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model; the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. In addition, unless otherwise explicitly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. For those skilled in the art, the specific meaning of the above terms in this utility model can be understood according to the specific circumstances.

[0036] The method for testing the breaking strength of the suture is Appendix B of YY 1116-2020 Absorbable Surgical Sutures. Since it is a barbed, knot-free suture, knotting is not required during the test.

[0037] The method for testing the gripping force of barbs is as follows:

[0038] Surgical suturing was performed in a simulated clinical procedure. A suture with needles was inserted into the subcutaneous tissue of the pig along the direction of the barbs (fresh pig skin or frozen-thawed pig skin (with tissue) was used; the tissue size was 10×1×0.6cm, and the tissue thickness was 0.4–0.6cm). The needle insertion points were spaced 5mm apart, and six suture entry points were selected to suture along the direction of the barbs. After puncture, the tissue was tightened to make the barbs adhere. The sutured pig skin tissue was fixed to one side of a clamp, and the suture was fixed to the other side. At a specified speed (tension speed set at 100mm / min, test gauge length at 50mm), the suture was stretched against the direction of the barbs until the barbs slipped off. The maximum tensile force was recorded as the single-strand barb gripping force value. In Examples 1-6, multiple sutures were combined to form a suture with a total length of 2.5cm for gripping force testing. The average gripping force of all sutures was then calculated as the average barb gripping force value of the tested sutures.

[0039] Example 1

[0040] like Figure 1As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. A single-angle cut of 166° is used, with a radial depth of 0.14 mm and an axial length of 0.6 mm. The axial spacing of the barbs is 0.58 mm. The wire diameter retention rate is 75.25%. There are 17 barbs per centimeter.

[0041] After testing, the barb gripping force was 37.29N, the barb formation angle was 15°, the barb angle piercing pigskin tissue was 8°, and the linear breaking strength was 68.18N.

[0042] A single-angle cut results in less barb gripping force. Because the contact area between the barb and the suture body is relatively flat, when the suture moves in the opposite direction after passing through the wound, some of the barbs will not open and thus cannot form a locking force.

[0043] Single-angle cutting of barbed sutures results in uneven strength and tension, a large cutting depth, significant damage to the suture body, and a high risk of breakage. The resulting barbs tend to close after suturing, and their insufficient gripping force means that knotless sutures still require knotting, thus negating the function of the barb structure.

[0044] Example 2

[0045] like Figure 2 As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. It employs a dual-angle cutting method: a first cutting angle of 125° and a second cutting angle of 5°, with a radial cutting depth of 0.067 mm and an axial cutting length of 0.392 mm; the wire diameter retention rate is 88.39%. There are 17 barbs per centimeter.

[0046] After testing, the barb gripping force was 41.73N, the barb formation angle was 60°, the barb angle piercing pigskin tissue was 55°, and the linear breaking strength was 74.75N.

[0047] Double-angle cutting increases the gripping force of the barbs; however, since the contact area between the barbs and the suture body is still relatively flat, when the suture moves in the opposite direction after passing through the wound, some of the barbs will not open and will not be able to form a locking force.

[0048] Compared to Example 1, this embodiment features a dual-angle cut with a shallower barb cut, preserving more of the suture diameter and thus its strength. The barbs provide better grip on the tissue, firmly locking it in place and eliminating the need for knotting. This cutting method ensures both the strength of the suture (the tension required for wound healing) and the enhanced gripping force created by the barbs after suturing, preventing suture slippage during clinical application.

[0049] Example 3

[0050] like Figure 3 As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. It employs a dual-angle cutting method: a first cutting angle of 132° and a second cutting angle of 8°, with a radial cutting depth of 0.052 mm and an axial cutting length of 0.268 mm; the wire diameter retention rate is 90.99%. There are 18 barbs per centimeter.

[0051] After testing, the barb gripping force was 53.13N, the barb formation angle was 65°, the barb angle piercing pigskin tissue was 60°, and the linear breaking strength was 72.25N.

[0052] Simultaneously, at the contact area formed when the barbs and suture body close, the suture body is cut again to create a wavy, shallow indentation. The shallow indentation is observed in cross-section using the plane formed by the barb's line of symmetry and the suture axis. The indentation depth is 0.04 mm, and the axial distance between the adjacent barbs is 0.56 mm.

[0053] The barbs are distributed along the suture direction, and the lines connecting the barbs form a straight line on the suture body that is parallel to the suture axis.

[0054] Because the contact area between the barb and the suture body is not smooth, the barb and the suture body will inevitably be subjected to forces in multiple random directions as the barb passes through the wound. This makes it easier for the barb and the suture to separate at the moment the barb passes through the wound tissue. As a result, when the force is reversed in the subsequent movement, the barb can basically open and get stuck on the wound tissue to form a locking force, so the doctor does not need to tie the suture.

[0055] Example 4

[0056] like Figure 4 As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. A dual-angle cutting method was employed: a first cutting angle of 136° and a second cutting angle of 10°, with a radial cutting depth of 0.058 mm and an axial cutting length of 0.258 mm; the wire diameter retention rate was 89.95%. There were 16 barbs per centimeter. Testing revealed a barb holding force of 50.88 N, a barb formation angle of 66°, a barb angle of 62° for piercing pigskin tissue, and a linear tensile strength of 71.32 N.

[0057] Simultaneously, at the contact area formed when the barbs and suture body close, the suture body is cut again to create a wavy, shallow indentation. The shallow indentation is observed in cross-section using the plane formed by the barb's line of symmetry and the suture axis. The indentation depth is 0.05 mm, and the axial distance between the adjacent barbs is 0.64 mm.

[0058] The barbs are distributed along the suture direction, and the lines connecting the barbs form three evenly distributed straight lines on the suture body that are parallel to the suture axis.

[0059] Because the contact area between the barb and the suture body is not smooth, the barb and the suture body will inevitably be subjected to forces in multiple random directions as the barb passes through the wound. This makes it easier for the barb and the suture to separate at the moment the barb passes through the wound tissue. As a result, when the force is reversed in the subsequent movement, the barb can basically open and get stuck on the wound tissue to form a locking force, so the doctor does not need to tie the suture.

[0060] Example 5

[0061] like Figure 4 As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. A dual-angle cutting method was employed: a first cutting angle of 135° and a second cutting angle of 6°, with a radial cutting depth of 0.061 mm and an axial cutting length of 0.258 mm; the wire diameter retention rate was 89.43%. There were 17 barbs per centimeter. Testing revealed a barb holding force of 48.52 N, a barb formation angle of 61°, a barb angle of 57° for piercing pigskin tissue, and a linear tensile strength of 70.14 N.

[0062] Simultaneously, at the contact area formed when the barbs and suture body close, the suture body is cut again to create shallow, serrated notches. These shallow notches are observed in cross-section using the plane formed by the barb's line of symmetry and the suture axis. The notch depth is 0.06 mm, and the axial distance between the adjacent barbs is 0.58 mm.

[0063] The barbs are distributed along the suture direction, and the lines connecting the barbs form three evenly distributed straight lines on the suture body that are parallel to the suture axis.

[0064] Because the contact area between the barb and the suture body is not smooth, the barb and the suture body will inevitably be subjected to forces in multiple random directions as the barb passes through the wound. This makes it easier for the barb and the suture to separate at the moment the barb passes through the wound tissue. As a result, when the force is reversed in the subsequent movement, the barb can basically open and get stuck on the wound tissue to form a locking force, so the doctor does not need to tie the suture.

[0065] Example 6

[0066] like Figure 4As shown, this embodiment uses single-strand PDO (polydioxanone) wire with a diameter of 0.577 mm. It employs a dual-angle cutting method: a first cutting angle of 123° and a second cutting angle of 9°, with a radial cutting depth of 0.069 mm and an axial cutting length of 0.385 mm; the wire diameter retention rate is 88.04%. There are 17 barbs per centimeter.

[0067] After testing, the barb gripping force was 49.52N, the barb formation angle was 64°, the barb angle piercing pigskin tissue was 59°, and the linear breaking strength was 69.86N.

[0068] Simultaneously, at the contact area formed when the barbs and suture body close, the suture body is cut again to create shallow, serrated notches. These shallow notches are observed in cross-section using the plane formed by the barb's line of symmetry and the suture axis. The notch depth is 0.07 mm, and the axial distance between the adjacent barbs is 0.6 mm.

[0069] The barbs are distributed along the suture direction, and the lines connecting the barbs form three evenly distributed straight lines on the suture body that are parallel to the suture axis.

[0070] Because the contact area between the barb and the suture body is not smooth, the barb and the suture body will inevitably be subjected to forces in multiple random directions as the barb passes through the wound. This makes it easier for the barb and the suture to separate at the moment the barb passes through the wound tissue. As a result, when the force is reversed in the subsequent movement, the barb can basically open and get stuck on the wound tissue to form a locking force, so the doctor does not need to tie the suture.

[0071] In summary, this invention can preserve the strength of the suture to the greatest extent, cause minimal damage to the suture body, and ensure the tension required for the wound healing cycle; after the suture penetrates the tissue, the barb structure will not form a closure, making it more secure when stretched in the opposite direction to form a gripping force, thus reducing the occurrence of suture scratches.

[0072] The preferred embodiments of this utility model have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of this utility model without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of this utility model through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A barbed, knot-free suture with a composite cutting structure, characterized in that, It includes a suture body, barbs, and shallow scoring. The barbs are formed by a double-angle cutting process, with a first cutting angle of 123° to 136°, a second cutting angle of 5° to 10°, a cutting radial depth of 0.052 to 0.069 mm, a thread diameter retention rate of not less than 85%, and a cutting axial length of 0.258 to 0.392 mm. The shallow scoring is located on the suture body in the area where the barbs contact the suture body.

2. The barbed, knotless suture according to claim 1, characterized in that, The first cutting angle is 132°.

3. The barbed, knotless suture according to claim 1, characterized in that, The second cutting angle is 8°.

4. The barbed, knotless suture according to claim 1, characterized in that, The shallow scoring depth is 5% to 15% of the diameter of the suture body.

5. The barbed, knotless suture according to claim 4, characterized in that, The shallow scoring has a scoring depth of 6.93% to 12.13% of the diameter of the suture body.

6. The barbed, knotless suture according to any one of claims 4 or 5, characterized in that, The shape of the shallow indentation is one of the following: wavy, sawtooth, zigzag, or spiral.

7. The barbed, knotless suture according to claim 1, characterized in that, The axial spacing of the barbs is 0.56–0.64 mm.

8. The barbed, knotless suture according to claim 7, characterized in that, The barbs are distributed along the suture direction, and the lines connecting the barbs form one or more straight lines parallel to the suture axis on the suture body.

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