Double-angle knotting-free barb suture line and preparation method thereof

Abstract

The invention relates to a double-angle knotting-free barb suture line and a preparation method thereof, and relates to the technical field of medical instruments. The double-angle knotting-free barb suture line comprises a suture needle and a suture line body, and the suture line body comprises a suture line body and a barb structure; the surface of the suture line body is subjected to double-angle cutting to form a barb structure, and the double-angle cutting means that after the suture line body is sheared once on the surface of the suture line body through a shearing tool at a first shearing angle, the shearing tool conducts second-time cutting through a second shearing angle with the first-time shearing tail end as a starting point, and the second-time shearing tail end serves as a second shearing angle. And a barb structure with limited shearing depth, shearing length and shearing density is formed. According to the double-angle knotting-free barb suture line, the tissue grasping force and the barb fixing strength can be effectively increased through double-angle cutting, and the risk of operation failure caused by suture line breakage is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and more particularly, to a double-angle knotless barbed suture and a preparation method thereof, which is used for closing a blood vessel closure clamp and the like pipeline tissue. BACKGROUND

[0002] Medical sutures are a kind of sterile suture materials, which are mainly used for promoting wound healing, implementing tissue ligation and fixation. In clinical surgical suturing, in order to reduce the risk of slipping, the operator usually needs to tie 3 knots (even 5-8 knots for easy-to-slip sutures), but too many knots may cause excessive tissue tension, insufficient skin blood supply, and stress concentration at the knot, thereby increasing scars and affecting appearance.

[0003] There are many studies in the prior art to improve the anti-slippage performance of monofilament sutures by designing barb structures on the surface of the sutures. Like traditional suture materials, the knotless barbed suture is composed of a barbed suture body and a stop element, and has an absorbable structure. The surface barbs are arranged in the axial direction, realizing one-way free movement and reverse anchoring function, and at the same time, the barbs can optimize the wound closure effect by uniformly dispersing the suture tension and significantly reduce postoperative pain.

[0004] At present, there are many technologies for processing barb structures on sutures, including mechanical cutting, laser cutting, injection molding, stamping and extrusion processes. However, with the increasing requirements of surgical operations on fixation strength, the traditional barbed monofilament sutures gradually show performance limitations in special operations.

[0005] CN101125096B discloses a method for manufacturing barbed sutures by changing the geometry of the blade and / or the movement of the blade when cutting the suture. The method can use a cutting device to create a plurality of barbs on the outside of the surgical suture. The barbs created by the method using the cutting device can be of the same configuration or of a random configuration.

[0006] CN101518457A discloses a composite barbed medical device, which includes an elongated body having at least one barb formed along its length. The barb defines an inner surface having a first portion arranged in a first direction relative to a longitudinal axis of the elongated body and a second portion arranged in a second direction relative to the longitudinal axis. Optionally, the inner surface also has a third portion arranged in a third direction relative to the longitudinal axis.

[0007] CN101683278A discloses a suture comprising a ring with a tapered surface. The suture includes an elongated body having a proximal portion and a distal portion, wherein the distal portion includes first and second overlapping regions and a ring. The proximal end of the first overlapping region may taper gradually relative to the longitudinal axis of the elongated body. The first overlapping region may be fixed proximally to a second overlapping region of the ring. The overlapping regions may be fixed together by at least one method selected from adhesives, bonding agents, epoxy compounds, solvents, heat, and ultrasonic energy.

[0008] The aforementioned barbed sutures are typically created by mechanical or laser cutting to create incisions or grooves on the suture surface, resulting in high-angle barbs. However, these processed barbs become stress concentration points, leading to lower barb support, and deeper cuts may compromise the strength of the suture body. In high-stress surgical applications (such as heart valve repair / replacement or orthopedic surgery), the barbs may fail or even detach from the suture body. If this occurs, due to the fibrous properties of the suture material, the barbs may gradually peel away along the suture axis, leading to serious clinical risks. Summary of the Invention

[0009] In order to solve the above-mentioned technical problems existing in the prior art, the purpose of this invention is to provide a double-angle knotless barbed suture.

[0010] The present invention relates to a double-angle knotless barbed suture, comprising a suture needle and a suture, wherein the suture comprises a suture body and a barbed structure; characterized in that: the surface of the suture body is formed into a barbed structure by double-angle cutting, wherein the double-angle cutting refers to: after the suture body is cut once at a first cutting angle by a cutting tool, the cutting tool, starting from the end of the first cut, performs a second cut at a second cutting angle to form a barbed structure with a defined cutting depth, cutting length, and cutting density.

[0011] The barbs are spirally or interlaced on the surface of the suture line.

[0012] The first cutter has a cutting angle of 125° to 165°, and the second cutter has a cutting angle of 120° to 175°.

[0013] The first cutter has a cutting angle of 135° to 165°, and the second cutter has a cutting angle of 135° to 165°.

[0014] The barb cutting depth is 10% to 30% of the diameter of the suture body; the shear density of the barb structure is 10 to 25 barbs / cm; and the barb cutting length is 0.20 to 0.6 mm.

[0015] The angle between the barb structure and the central axis of the suture body is 25° to 45°.

[0016] The barb structure on the suture body includes a forward barb segment and a reverse barb segment, and the barb openings of the forward barb segment and the reverse barb segment are in opposite directions.

[0017] The suture thread is formed as a single strand, and the material of the suture thread is at least one of biodegradable and / or non-biodegradable materials.

[0018] The biodegradable material includes polyester, polyhydroxybutyrate, polyglycolic acid, polylactide, polyglycolic acid, polycaprolactone, or polydioxane.

[0019] The non-degradable materials include polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polyimide, or polyurethane.

[0020] The end of the suture is provided with a stop element.

[0021] The stop element is ring-shaped, triangular, spherical, or rectangular.

[0022] This invention also relates to a method for preparing the above-mentioned double-angle knotless barbed suture, which includes the following steps:

[0023] S1. Cut the suture material at two angles using a cutting tool;

[0024] S2. A barb structure with defined shear depth, shear length, and shear density is formed by double-angle cutting.

[0025] The preparation method further includes:

[0026] S3. Process the tail end of the suture to form a stop element.

[0027] The end of the suture is fixed to the stop element by ultrasonic welding or hot melting.

[0028] Compared with the prior art, the double-angle knotless barbed suture of the present invention has the following beneficial effects:

[0029] The double-angle knotless barbed suture of this invention features a specially designed double-angle barbed structure on its surface, which significantly enhances tissue gripping force while maintaining the required breaking strength for the same suture diameter. This suture can shorten intraoperative suturing time, improve surgical efficiency, and provide more reliable safety and effectiveness for postoperative recovery. Attached Figure Description

[0030] Figure 1This is a schematic diagram of the single-needle double-angle knotless barbed suture of the present invention;

[0031] Figure 2 This is a schematic diagram of the structure of the double-needle, double-angle, knot-free barbed suture in this invention;

[0032] Figure 3 This is a schematic diagram of the double-angle cutting structure of the suture portion in the present invention.

[0033] Figure 4 This is a schematic diagram of the suture stop element in the present invention.

[0034] Figure reference numerals: 1-suture needle, 2-suture thread body, 3-barb structure, 301-positive barb section, 302-negative barb section, 4-stop element, 6-first shearing angle, 7-second shearing angle, 8-shearing length, 9-shearing depth, 10-thread diameter. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solution will be clearly and completely described below in conjunction with the embodiments of this invention. Obviously, the described embodiments are only a part of the embodiments of this invention, not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without inventive effort are within the scope of protection of this invention.

[0036] The purpose of this invention is to develop a suture that combines excellent tissue holding power with good suture structural integrity. The dual-angle cutting method of this invention not only effectively disperses stress concentration but also unexpectedly improves the suture's breaking strength. The suture of this invention reduces the cutting depth, decreasing the risk of barbs breaking at the root under stress, thereby maintaining the suture's original strength.

[0037] Specifically, such as Figures 1-3As shown, this invention provides a double-angle knotless barbed suture, comprising a suture body 2 and a barbed structure 3, with a suture needle 1 at at least one end. The surface of the suture body 2 is formed into the barbed structure 3 by double-angle cutting. One end of the suture body 2 can be connected to the suture needle 1, and the other end can be connected to a stop element 4 for fixation. The double-angle cutting refers to the following: after the suture body 2 is cut once at a first cutting angle 6 by a cutting tool, the cutting tool, starting from the end of the first cut, performs a second cut at a second cutting angle 7, forming a barbed structure 3 with a defined cutting depth, cutting length, and cutting density. The double-angle cutting structure design of this invention can generate barbs with strong anchoring force, facilitating the fixation of barbs in normal subcutaneous soft tissue, improving tissue gripping force, and meeting the minimum breaking strength of the suture diameter. The barbed cutting depth 9 is 10% to 30% of the suture diameter 10, preferably 15% to 25%. The barbs are spirally or interlaced on the suture surface, and the shear density of the barbs is 10-25 barbs / cm. In this invention, the barb cutting length 8 can be set to 0.20-0.6 mm. Preferably, as... Figure 2 As shown, the barb structure 3 on the suture body 2 includes a forward-pointing barb section 301 and a reverse-pointing barb section 302, with the barb openings of the barb section 301 and the reverse-pointing barb section 302 facing opposite directions. By providing the forward-pointing barb section 301 and the reverse-pointing barb section 302, the tissue gripping force can be further enhanced. In this invention, the angle of the barb structure 3 relative to the central axis of the suture body 2 is 25° to 45°. Figure 4 As shown, the stop element at the end of the suture 2 can be ring-shaped, triangular, spherical, rectangular, etc. If it is a single-incision suture, the stop element may remain inside the body; to prevent injury to internal organs, triangular, spherical, or rectangular stop elements are optimal. The end of the suture 2 is fixed to the stop element 4 by ultrasonic welding or heat fusion.

[0038] Preferably, the suture 2 is formed as a single strand; the suture 2 is made of at least one of biodegradable and / or non-biodegradable materials. Biodegradable materials include polyester, polyhydroxybutyrate, polyglycolic acid, polylactide, polyglycolic acid, polycaprolactone, polydioxane, etc., while non-biodegradable materials include polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polyimide, polyurethane, etc. Preferably, the first cutting angle 6 is 125°–165°, more preferably 135°≤X≤165°. The second cutting angle 7 is 120°–175°, more preferably 135°≤X≤165°.

[0039] Example 1

[0040] This embodiment uses single-strand PDO suture, size 2, with an average thread diameter of 0.587mm. The suture is cut at two angles: a first cut angle of 150° and a second cut angle of 150°, with a cut depth of 0.1mm and a cut density of 12 cuts / cm. Finally, the suture is connected with needle and thread to form a needle-supported suture.

[0041] Example 2

[0042] This embodiment uses single-strand PDO suture, size 0, with an average thread diameter of 0.40mm. The suture is cut at two angles: a first cut angle of 150° and a second cut angle of 150°, with a cut depth of 0.08mm and a cut density of 15 cuts / cm. Finally, the suture is connected with needle and thread to form a needle-supported suture.

[0043] Example 3

[0044] This embodiment uses single-strand PDO suture, with a 4-0 gauge and an average thread diameter of 0.22mm. The suture is cut at two angles: a first cut angle of 150° and a second cut angle of 150°, with a cut depth of 0.05mm and a cut density of 18 cuts / cm. Finally, the suture is joined together with needle and thread to form a needle-supported suture.

[0045] Performance testing:

[0046] 1. Fracture strength test

[0047] Quill, an absorbable surgical suture manufactured by Surgical Specialties Corporation of the United States, is used for soft tissue sutures. TM As a comparison, the PDO Knotless Tissue-Closure Device (Polydioxanone) was used. Control Example 1 used suture No. 2, Control Example 2 used suture No. 0, and Control Example 3 used suture No. 4-0. Control Examples 1-3 involved cutting to create high-incision, single-angle barbs, with cutting density and depth similar to Examples 1-3. The medical sutures prepared according to Examples 1, 2, and 3 were compared with their controls 1, 2, and 3. Five samples were prepared for each test, and the average value of the results was taken.

[0048] Table 1 Comparison of fracture strength between different embodiments and control examples.

[0049]

[0050] According to the test results in Table 1, the sutures cut by the present invention can still maintain the integrity of the suture body and meet the breaking strength requirements of this suture diameter, making them more suitable for use in corresponding clinical scenarios.

[0051] 2. Organization gripping force test

[0052] The medical sutures prepared in Examples 1, 2, and 3 were combined with those in Control Examples 1, 2, and 3 to form a "U-shaped suture" along a direction perpendicular to the muscle fibers of the pig hind leg. The pig hind leg meat with the U-shaped suture was fixed to the lower clamp of the material testing machine, and the end of the suture was fixed to the upper clamp. With the suture in its natural state, the suture was pulled out of the muscle at a specified speed. Each experiment was repeated 5 times, and the maximum tensile force value was recorded as the barb gripping force value. Five sutures of each type were taken, and the average value was recorded.

[0053] Table 2 Comparison of tissue gripping force between different embodiments and control examples.

[0054] Sample Suture Gauge Tissue Grasp Example 1 2 13.2N Control 1 2 8.1N Example 2 0 9.4N Control 2 0 3.8N Example 3 4-0 2.6N Control 3 4-0 2N

[0055] Compared with the examples, the control example tissue had less gripping force, while the suture tissue after the dual-angle cutting of the present invention had increased gripping force, resulting in significant clinical benefits.

[0056] The above description is merely a preferred embodiment of the present invention. The present invention uses these embodiments to illustrate the performance advantages and preparation method of the leak-proof medical suture with needles. However, the present invention is not limited to the above embodiments. Any modifications, equivalent substitutions, or improvements made within the scope of the principles of the present invention, as well as any improvements to the present invention, equivalent substitutions of the raw materials used in the present invention, and selection of specific methods, all fall within the protection and disclosure scope of the present invention.

Claims

1. A double-angle knotless barbed suture, comprising a suture needle and a suture, wherein the suture includes a suture body and a barbed structure; characterized in that: The surface of the suture body is formed with a barb structure by double-angle cutting. The double-angle cutting means that after the suture body is cut once at a first cutting angle by a cutting tool, the cutting tool takes the end of the first cut as the starting point and then makes a second cut at a second cutting angle to form a barb structure with a limited cutting depth, cutting length and cutting density.

2. The double-angle knotless barbed suture according to claim 1, characterized in that: The barbs are spirally or interlaced on the surface of the suture.

3. The double-angle knotless barbed suture according to claim 1, characterized in that: The first cutter has a cutting angle of 125° to 165°, and the second cutter has a cutting angle of 120° to 175°.

4. The double-angle knotless barbed suture according to claim 3, characterized in that: The first cutter has a cutting angle of 135° to 165°, and the second cutter has a cutting angle of 135° to 165°.

5. The double-angle knotless barbed suture according to claim 1, characterized in that: The cutting depth of the barb structure is 10% to 30% of the diameter of the suture body; the shearing density of the barb structure is 10 to 25 barbs / cm; and the cutting length of the barb structure is 0.20 to 0.6 mm.

6. The double-angle knotless barbed suture according to any one of claims 1-5, characterized in that: The angle between the barb structure and the central axis of the suture body is 25° to 45°.

7. The double-angle knotless barbed suture according to any one of claims 1-5, characterized in that: The barb structure on the suture body includes a forward barb segment and a reverse barb segment, and the barb openings of the forward barb segment and the reverse barb segment are in opposite directions.

8. The double-angle knotless barbed suture according to any one of claims 1-5, characterized in that: The suture thread is formed by single strand molding, and the material of the suture thread is at least one of biodegradable and / or non-biodegradable materials.

9. The double-angle knotless barbed suture according to claim 8, characterized in that: The biodegradable material includes polyester, polyhydroxybutyrate, polyglycolic acid, polylactide, polyglycolic acid, polycaprolactone, or polydioxane.

10. The double-angle knotless barbed suture according to claim 8, characterized in that: The non-degradable materials include polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polyimide, or polyurethane.

11. The double-angle knotless barbed suture according to claim 10, characterized in that: The end of the suture is provided with a stop element.

12. The double-angle knotless barbed suture according to claim 11, characterized in that: The stop element is ring-shaped, triangular, spherical, or rectangular.

13. The method for preparing the double-angle knotless barbed suture according to any one of claims 1-12, characterized in that... Includes the following steps: S1. Cut the suture material at two angles using a cutting tool; S2. A barb structure with defined shear depth, shear length, and shear density is formed by double-angle cutting.

14. The method for preparing the double-angle knotless barbed suture according to claim 13, characterized in that... The preparation method further includes: S3. Process the tail end of the suture to form a stop element.

15. The method for preparing the double-angle knotless barbed suture according to claim 14, characterized in that: The end of the suture is fixed to the stop element by ultrasonic welding or hot melting.

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