KR102657688B1 - Manufacturing method of fabricating suture and the suture manufactured therefrom - Google Patents

Abstract

The present invention relates to a method for manufacturing a suture and a suture manufactured therefrom. When supplying suture yarn, the suture supply part and the suture cutting part are lowered than the suture forming part so that the yarn is formed with a tensile force, and the formed suture is formed using a roller method. It is cut by length using a conveyor method rather than a conveyor method to prevent dust caused by roller operation, and the shape of the formed suture is not pressed, improving tensile strength and producing sutures with consistent quality.

Description

Manufacturing method of suture and suture manufactured therefrom

The present invention relates to a method for producing a suture and a suture produced therefrom. More specifically, it relates to a method of manufacturing a suture with improved tensile strength by adjusting the length, height, spacing, and angle of the barbs.

In surgical procedures, sutures have been used to connect or close damaged muscles, blood vessels, nerve tissue, wounds, or surgical incisions. In addition, as interest in beauty has increased recently, sutures have been used in addition to surgical procedures to remove sagging tissue, skin, and wrinkles caused by double eyelid surgery, aging, loss of skin elasticity, trauma, overuse, necrosis, etc. It is also used for surgical procedures, etc.

For example, a lifting procedure using sutures is a technique that lifts or pulls sagging skin and tissues of the face, chin, neck, abdomen, vagina, chest, hips, etc. using a needle and thread without using a knife. It is in the spotlight because there is no need to make excessive skin incisions, the occurrence of scars can be minimized, and bleeding or swelling due to surgery is minimal.

Natural and synthetic materials can be used as materials for suture (stitching fiber), and depending on the material, it has absorbent or non-absorbable characteristics. Materials for natural absorbable sutures include catgut, chromic, and gut, and materials for synthetic absorbable sutures include polyglycolic acid (dexone, mexon), and polygl. Lactin (bicryl) and polydioxanone (PDS) can be used. Silk can be used as a material for natural non-absorbable sutures. Materials for synthetic non-absorbable sutures include polyester (dacron), polypropylene (proline), polyamide (nylon), and e-PTFE (Gore-Tex).

The suture may include a number of protrusions (eg, barbs) on its surface to increase knotting or lifting efficiency. For example, a separate incision or cutting process is required to form the protrusions on the outer surface of the suture. Additionally, a compression process may be performed to form the suture into a desired thickness and shape.

A typical method of manufacturing barbed sutures for surgical tissue suture and plastic surgery is cutting, and is currently used in the manufacture of the majority of commercially available products. However, in the case of the cutting method, the surface of the suture yarn is shaved to form barbs, so the size and thickness of the barbs are limited, and the ends of the barbs are too sharp, which can irritate surrounding tissues and nerves. Disadvantages include the fact that the strength decreases sharply compared to sutures of the same size due to damage to the suture thread, and the relatively thin barbs manufactured by cutting are rapidly bioabsorbed in the body and easily lose their tissue fixation power. there is.

For example, Korean Patent No. 1806150 relates to a medical suture manufacturing device and a method of manufacturing medical sutures, which includes a suture supply unit for supplying suture yarn, a preheating unit for heating the suture yarn to a predetermined temperature, and tension on the suture yarn. Discloses a medical suture manufacturing device including a twist prevention unit that generates and removes stagnation generated in the preheating unit, and Korean Patent No. 1642962 relates to suture and its manufacturing method, heating the suture raw material under set temperature conditions. A first step, a second step of pressing and molding the heated suture raw material, forming cutting lines on the first and second corners of the formed suture compression molding, and applying a tensile force to the suture compression molding on which the cutting lines are formed. A third step of forming a barbed portion by adding a barb portion, wherein the cutting line is inclined at a constant angle toward one or both directions of the first edge and the second edge and is formed continuously at a predetermined interval to form a seam portion. A method for manufacturing a suture with excellent recovery, semi-permanent lifting effect, and excellent strength is disclosed. Korean Patent No. 1057377 relates to a medical suture having fine protrusions on the surface and a method for manufacturing the same. A step of manufacturing a suture body with micro protrusions formed on the surface of the suture by heat-pressing the raw material in an overflow mold using a solid-phase forming method and under specific temperature conditions. A method of manufacturing a medical thread with fine protrusions formed on the surface of the suture is disclosed, which includes the step of manufacturing a suture whose twist is maintained by applying tension and rotational force to the suture body in a maintained vacuum state.

However, there has been no disclosure regarding sutures manufactured using the manufacturing method and form of the present invention.

1. Korean Patent No. 1806150 2. Korean Patent No. 1642962 3. Korean Patent No. 1057377

The present invention includes a suture supply unit that supplies suture yarn, a preheating unit that continuously heats the suture yarn to a temperature below the melting point or above the glass transition temperature when processing the suture yarn, a molding unit that presses and molds the yarn from the upper and lower surfaces, and The purpose of the present invention is to provide a method for manufacturing a suture having excellent tensile strength, including a winding unit that moves and cuts the barbs formed in the molding unit to the specifications of the final product, and a suture manufactured therefrom.

In order to achieve the above object, the present invention includes a suture supply unit that supplies suture yarn; a suture preheating unit that heats the suture yarn; a suture molding unit that presses and molds the suture yarn; and a suture winding unit that moves and cuts the barbed suture in the suture forming unit, wherein the cutting is performed in a suture cutting unit, and the suture supply unit and the suture cutting unit are located lower than the suture forming unit. It provides a suture manufacturing method characterized by a suture manufacturing method.

The barbs may have a length of 0.4 to 1.5 mm, a height of 0.2 to 0.3 mm, a spacing of 1.0 to 3.0 mm, an angle (1) of 15 to 40 degrees and an angle (2) of 30 to 80 degrees, preferably the barbs have a length of 0.5 mm. , height 0.26 mm, spacing 1.5 mm, angle (1) 35 degrees and angle (2) 70 degrees.

The suture yarn is at least one biomaterial selected from polydioxanone, poly-(l-actic)acid, polyglycolic acid, polycaprolactone, or copolymers thereof. Absorbent polymer material; Alternatively, it may include at least one bio-non-absorbable polymer material selected from polypropylene, nylon, or mixtures thereof.

The suture supply unit may include a guide roller.

The suture preheating unit may be heated to a temperature of 35°C to 200°C.

The barbs may be formed by compression molding of the upper and lower plates of the suture molding unit.

The upper and lower plates of the suture molding unit may include a mold with a size of 100 to 500 mm for forming barbs.

The barbed suture may be moved by a hydraulic or pneumatic clamp, and the clamp may be moved by a conveyor method.

Additionally, the present invention provides a suture manufactured by the above manufacturing method.

It was confirmed that the tensile strength of the suture manufacturing method according to the present invention and the suture produced thereby was improved compared to existing sutures due to changes in the shape of the barbs, and that the static electricity generated while collecting the previously produced sutures using a roller method was confirmed. It has the advantage of preventing the formation of dust (foreign substances) and enabling the production of products in which the tensile strength of the suture can be maintained consistently because the shape of the molded product is not pressed.

1 is a schematic configuration diagram showing a suture manufacturing device.
Figure 2 shows a schematic diagram of a suture having barbs being moved and cut in the winding section.
Figure 3 shows an exemplary shape of barbs formed on a suture.
Figure 4 shows a side view of the suture in an oblique form (top) and a straight form (bottom).
Figure 5 shows a cross-sectional view of the suture.
Figure 6 shows a side view of a suture from another company (comparative example).
Figure 7 shows an exemplary configuration of suture barbs.

Hereinafter, preferred embodiments of the present invention will be described in detail. In addition, in the following description, many specific details, such as specific components, are shown, but this is provided to facilitate a more general understanding of the present invention, and it is known in the art that the present invention can be practiced without these specific details. It will be self-evident to those who have the knowledge. Additionally, in describing the present invention, if it is determined that a detailed description of a related known function or configuration may unnecessarily obscure the gist of the present invention, the detailed description will be omitted.

The suture manufacturing method of the present invention and the suture manufactured therefrom are described with reference to the attached drawings.

1 is a schematic configuration diagram showing a suture manufacturing device.

Referring to FIG. 1, the suture manufacturing device may include a suture supply unit 20, a suture preheating unit 40, a suture forming unit 50, and a suture winding unit 60. The suture supply unit 20 may include, for example, a spool structure through which the suture yarn 10 can be wound and supplied.

The suture yarn 10 may include a bioabsorbable polymer or a bionon-absorbable polymer. The suture yarn 10 is, for example, polydioxanone, poly-(l-actic) acid, polyglycolic acid, polycaprolactone, or copolymers thereof. It may include at least one selected bioabsorbable polymer material. Alternatively, the suture yarn 10 may include at least one bio-non-absorbable polymer material selected from, for example, polypropylene, nylon, or mixtures thereof.

When supplying the suture yarn 10, the suture supply unit 20 and the suture cutting unit 64 are positioned lower than the suture forming unit 50 to automatically create tension. The suture yarn 10 is formed in the suture forming unit 50 in a tensile state (in a taut state), and the suture forming unit 50 is maintained at a certain temperature (above the glass transition temperature of the polymer material and below the melting temperature) and pressure. (approximately 100 kgf) is required, and the upper plate of the molding section is approximately 10 degrees higher than the lower plate. For the glass transition temperature and melting temperature of each polymer material, various literature in the technical field to which the present invention pertains can be referred.

The suture yarn 10 is discharged from the suture supply unit 20 and can be manufactured into suture thread by, for example, passing through the suture preheating unit 40 and the suture forming unit 140 through the guide roller 30.

In the suture preheating unit 40, the suture yarn 10 is heated to promote, for example, suture forming. The suture preheating unit 40 improves processability by increasing the ductility of the suture yarn 10, but may be designed to heat the suture yarn 10 in a temperature range that does not modify the polymer material or damage polymer crystallinity. .

For example, a heating wire may be built into the suture preheating unit 40, and a temperature sensor, a temperature control unit, etc. may be included to control the temperature of the heating wire. In some embodiments, the suture yarn 10 may be heated to a temperature above the glass transition temperature (Tg) and below the melting point (Tm) through the suture preheating unit 40. Preferably, the temperature may be a temperature of 35°C to 200°C, but is not limited thereto.

The mold installed in the suture forming unit 50 is divided into an upper suture plate 51 and a lower suture plate 52, and the upper suture plate 51 moves vertically, compressing the yarn and creating a shape. The size of the mold can be manufactured from 100 to 500 mm depending on the product size. The amount of pressure applied to the mold may range from 10 to 200 kgf/cm2, preferably 80 to 160 kgf/cm2, and more preferably 100 kgf/cm2, but is not limited thereto.

The barbed suture that moves from the suture forming unit 50 to the suture winding unit 60 is cut to an appropriate size in the suture cutting unit 64 and produced as a final suture.

The suture winding unit 60 includes moving point 1 (61), moving point 2 (62), and moving point 3 (63), and moving point 2 (62) and moving point 3 (63) are the suture cutting section (64). ).

Figure 2 shows a schematic diagram of a suture having barbs being moved and cut in the winding section. Referring to Figure 2, the barb-shaped suture is held on both sides by the clamp 65 and moved, and is deployed to movement point 1 (61), movement point 2 (62), and movement point 3 (63). The barbed suture may be moved by a hydraulic or pneumatic clamp, and the clamp may be moved by a conveyor method. Specifically, the movement of the barb-formed suture proceeds in the following order.

1) At the first moving point 1 (61), the two clamps (65) are set together with the first clamp holding the suture.

2) When the first clamp reaches moving point 2 (62) while holding the suture at moving point 1 (61), the second clamp catches the suture at moving point 1 (61).

3) When the first clamp moves to moving point 3 (63) (=when it reaches a certain length), the second clamp also moves while being held to moving point 2 (62).

4) When the second clamp comes to movement point 2 (62), it is cut at the suture cut, and the first clamp places the suture at movement point 3 (63), and catches the suture as soon as it moves again to movement point 1 (61) (the second clamp The clamp must also continue to hold the thread at movement point 2 (62).

5) When the second clamp moves to moving point 3 (63) (=when it reaches a certain length), the first clamp also moves while being held to moving point 2 (62).

6) When the first clamp comes to moving point 2 (62), it cuts at the suture cut section, and the second clamp places the suture at moving point 3 (63), and catches the suture as soon as it moves again to moving point 1 (61). This is the same as 2) above.

Therefore, since the subsequent process is 3) above, “2) → 6)” is repeated to produce sutures.

The conveyor-type suture movement through the clamp 65 prevents the formation of dust (foreign substances) due to static electricity compared to the existing suture manufacturing method of collecting the produced sutures using a roller method, and the shape of the molded product is not pressed. It has the advantage of enabling the production of products in which the suture tensile strength can be maintained at a constant level.

Figure 3 shows an exemplary shape of barbs formed on a suture. Barb length refers to the length in the axial direction of the suture from the barb point (a) to the barb apex (b). Barb height refers to the vertical height from the suture axis (e) to the barb apex (b). The barb spacing refers to the length between the barb apex (b) and the adjacent barb apex (b). Angle (1) refers to the angle formed between the suture axis (e) and the first diagonal barb line (c). Angle (2) refers to the angle formed between the suture axis (e) and the barb 2 diagonal portion (d).

The barbs may have a length of 0.4 to 1.5 mm, a height of 0.2 to 0.3 mm, a spacing of 1.0 to 3.0 mm, an angle (1) of 15 to 40 degrees and an angle (2) of 30 to 80 degrees, preferably the barbs have a length of 0.5 mm. , height 0.26 mm, spacing 1.5 mm, angle (1) 35 degrees and angle (2) 70 degrees, but is not limited thereto. The thickness of the suture may be 0.2 mm to 0.4 mm, preferably 0.3 mm, but is not limited thereto.

Figure 4 shows a side view of the suture in an oblique form (top) and a straight form (bottom). Figure 5 shows a cross-sectional view of the suture. Figure 6 shows a side view of a suture from another company (comparative example).

Figure 7 shows an exemplary configuration of suture barbs. The suture of the present invention can be manufactured in an exemplary form using the above standard range of barbs, but is not limited thereto.

<Example> Suture manufacturing method

Polydioxanone suture yarn with a thickness of 0.3 mm was heated to 60°C through a preheating unit. Afterwards, the heated suture yarn was molded at a pressure of 100 kgf/cm ³ , and the specific manufacturing process is as shown in Figures 1 and 2.

As a comparative example , commercially available sutures from other companies were used, and the shapes of the sutures and barbs are shown in Figure 6.

The specifications of the barbed sutures manufactured in the specific examples and comparative examples are as shown in Table 1 below, and the thickness of each suture is the same at 0.3 mm.

barb Example
(Suture barbs of the present invention) Comparative Example
(Third party suture barbs) length 0.50mm 1.00mm height 0.26mm 0.22mm interval 1.50mm 3.00mm angle 1 35° 35° angle 2 70° -

<Test example> Tensile strength test

The USP 881 standard, designed by the United States Pharmacopoeia (USP), is the reference industry standard for testing the tensile strength of surgical sutures. Testing the tensile strength of surgical sutures is an important performance measurement to determine the likelihood of suture failure. Product development and quality control require accurate, consistent, and reliable power measurements. The United States Pharmacopoeia defines testing requirements for surgical sutures made from absorbable or nonabsorbable synthetic or natural materials.

For this purpose, all necessary mechanical tests are performed in advanced laboratories to prove the suitability of surgical sutures. For this purpose, in addition to the USP 881 standard, the USP 861 suture diameter and USP 871 needle attachment standards developed by the United States Pharmacopoeia are also applied.

Surgical sutures are frequently used for a variety of purposes in skin surgery. The basic mechanical properties of suture materials are important for general suture function and appropriate suture selection. In these tests, surgical sutures are expected to not break unexpectedly during use, not cause wound swelling, are biocompatible, easy to handle, form secure knots, and will not biodegrade within a reasonable period of time when used internally.

Knowledge of the tensile mechanical properties of various surgical suture materials allows evaluation of these properties. Among the commonly cited mechanical properties of surgical sutures, the most important are the basic tensile properties. Studies on the various tensile behavior of surgical sutures generally focus on the breaking force.

Sutures have the important function of holding body tissues together during the healing process. In this regard, it is generally evaluated by tensile and knot strength performance.

Testing according to the USP 881 standard uses an electric tensile strength tester with appropriate clamps to securely clamp the specimen. In this test, the tensile strength of the surgical suture is determined using the principle of a constant load ratio to the specimen or the principle of a constant elongation rate of the specimen.

The tensile strength of the suture is measured using a motor-driven tensile load meter that operates on the principle of constant rate of load or constant rate of elongation. The device is equipped with two clamps to hold the specimen, one of which is mobile and moves at a constant speed of 30 ± 5 cm/min. And the gauge length, that is, the gap between clamps, is set to 125 to 200 mm. Clamps should be designed to hold the specimen without slipping during testing. For gauge lengths of 125 mm or less, the tensile speed is twice the gauge spacing per minute.

The tensile load of sutures, whether dry or immersed in liquid, is measured immediately after removal from the packaging before the specimen is dried or conditioned. Place one end of the suture on the right and the other on the left, make a loop at one end, pass it through, pull it, and tie it in a simple knot. Attach one end of the suture to the load clamp of the tensile strength machine so that the knot is at the midpoint between the clamps, pass the other end through the opposite clamp, apply appropriate tension to the sample, tighten the suture, and secure the second clamp. Fix it on. The load when stretched and cut at a speed of 30 ± 5 cm/min is considered the tensile load. If the clamp breaks, discard the measurements for that specimen. However, sizes USP 9-0 and smaller are measured by straight pull, and among Class III (metal wire) monofilaments, sizes USP 0 and larger are also measured by straight pull.

Example
(Suture of the present invention) Comparative Example
(Third party suture) Tensile strength (N) 36 22

Considering the results in Table 2 above, it was confirmed that the manufacturing method of the present invention and having a specific shape had a significant tensile strength compared to the sutures of other companies.

10: Suture yarn
20: Suture supply unit
30: Guide roller
40: Suture preheating unit
50: Suture forming part
51: Top plate of molded part
52: Lower plate of molded part
60: Suture winding unit
61: Movement point 1
62: Movement point 2, suture cut section
63: Movement point 3
64: Suture cutting section
65: clamp

Claims (11)

A suture supply unit that supplies suture yarn;
a suture preheating unit that heats the suture yarn;
a suture molding unit that presses and molds the suture yarn; and
It includes a suture winding unit that moves and cuts the suture on which the barbs are formed in the suture forming unit,
The cutting is made at the suture cutting part, and the suture supply part and the suture cutting part are located lower than the suture forming part,
The barbs have the barb length of 0.5 mm, barb height of 0.26 mm, barb spacing of 1.5 mm, angle (1) of 35 degrees and angle (2) of 70 degrees as shown in Figure 3,
A method of manufacturing a suture, characterized in that the suture formed with the barbs is moved to a hydraulic or pneumatic clamp. delete delete The method of claim 1, wherein the suture yarn is polydioxanone, poly-(l-actic) acid, polyglycolic acid, polycaprolactone, or a copolymer thereof. At least one bioabsorbable polymer material selected from among; Or a suture manufacturing method comprising at least one bio-non-absorbable polymer material selected from polypropylene, nylon, or mixtures thereof. The method of claim 1, wherein the suture supply unit includes a guide roller. The method of claim 1, wherein the suture preheating unit is heated to a temperature of 35°C to 200°C. The method of claim 1, wherein the barbs are formed by compression molding of the upper and lower plates of the suture forming unit. The method of claim 7, wherein the upper and lower plates of the suture molding unit include molds with a size of 100 to 500 mm for forming barbs. delete The method of claim 1, wherein the clamp moves in a conveyor manner. Suture manufactured by the manufacturing method of any one of paragraphs 1, 4 to 8, and 10.

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