KR102579869B1 - manufacturing method of medical barb thread - Google Patents

Abstract

The present invention relates to a method of manufacturing barbed sutures for medical use.
The manufacturing method of the medical barbed suture of the present invention is to melt and extrude a biodegradable polymer, cool it, and repeat heating and stretching to integrally connect the central core portion 11 to the core portion 11. A thread manufacturing step of manufacturing a thread consisting of a barb portion 12 that protrudes radially around the core portion 11; and a barb processing step of manufacturing a barbed suture provided with barbs by partially removing the specific barbed portion 12 of the thread by a predetermined length.
According to the present invention, when manufacturing a thread provided for manufacturing a suture equipped with barbs, the thread is divided into a core portion, which is an area that is not damaged by cutting or pressing during barb forming, and a barb portion where barb processing is performed, Extrusion processing allows the core and barbs to be molded as one piece, allowing the barb performance to be demonstrated while minimizing damage to the core during barb processing.
In addition, the barb forming process can be easily performed by partially removing the barbs of the extruded thread by plucking rather than cutting or pressing.
In addition, as the thread is extruded into a non-circular cross-section, a groove is formed on the contact surface of the roller during the stretching process, and stretching is performed with the barb portion inserted into the groove, so that the shape of the barb portion of the final manufactured thread can be made constant. .

Description

Manufacturing method of medical barb thread}

The present invention relates to a method of manufacturing a medical barbed suture that is used for pain relief, skin care, plastic surgery, body shaping, skin lifting, etc. by stimulating acupuncture points through needle insertion therapy.

Recently, as interest in beauty has increased, various types of threads (sutures, threads, or lifting threads) are used when performing procedures to remove sagging tissue or skin and wrinkles caused by aging, loss of skin elasticity, or trauma. (also called thread) is used.

The thread lifting procedure is a medical technique that lifts or pulls sagging skin and tissues of the face, chin, neck, abdomen, etc. using a needle and thread without using a knife, and does not require excessive incisions in the skin. It is receiving a lot of attention because it can minimize the occurrence of scars as well as eliminate scars.

The lifting procedure involves inserting a thread into the hole of a medical needle, penetrating into the patient's skin tissue, placing the tip of the needle at the bottom of the patient's wrinkles in need of skin improvement, and then having the operator press the area near the epidermis with his or her fingers to penetrate the inside of the skin tissue. As the needle is discharged from the skin tissue while the thread discharged through the hole of the needle is pressurized and fixed, only the thread inserted into the needle remains inside the skin tissue.

The threads remaining in the skin tissue are dissolved and absorbed within the body several months after the procedure.

At this time, the thread becomes a factor that causes wound irritation within the skin tissue and promotes cellular activities such as the production of immune substances such as elastin and collagen that heal the wound, thereby healing the body tissue through which the thread passes. The volume is created by the immune substances produced around the skin, and the lifting state that pulls the skin tissue can be maintained continuously.

Therefore, various effects can be obtained, such as keeping sagging skin taut, smoothing out wrinkles, and improving elasticity, as well as improving blood and lymph circulation in the skin and improving skin moisturizing ability.

Typically, a plurality of protrusions or grooves are formed on the outer surface of a medical thread to increase knotting or lifting efficiency.

As a processing method for forming such protrusions or grooves, the "suture barb forming device" (Korean Patent Publication No. 10-2011032, Patent Document 1) involves scraping the surface of a yarn with a circular cross-sectional shape with a heated cutter to form barbs. The technology to do so is publicly available.

In the process of scraping the surface of the yarn with a circular cross-section like this, the core part becomes relatively small and the strength of the core part is not sufficient, resulting in the problem of the thread breaking during the procedure.

In order to solve this problem, if the depth and thickness of scraping to form barbs is reduced, there is a problem in that the thread comes out during the treatment process and the treatment effect is unsatisfactory.

Another technology, “Medical suture manufacturing device and method of manufacturing medical suture” (Korean Patent Publication No. 10-1779922, Patent Document 2), uses a molding device formed radially to surround a yarn with a circular cross-section and pressurizes the yarn. The technology for forming protrusions (barbs) has been disclosed.

Compared to Patent Document 1, Patent Document 2 has the advantage of reducing damage to the yarn by not cutting, but the point where the protrusion is formed by pressure has a smaller diameter than the point where the protrusion is not formed, so there is still a problem of lowering the strength of the thread. Depending on the treatment method, there is also a problem in that the thread cannot be inserted smoothly due to the uneven diameter.

In particular, the length of the barbs formed by pressure does not secure a sufficient length, so when actually applied to the human body, the friction force acting on the skin is small, which poses a problem in that the lifting effect is reduced due to a decrease in tensile force.

KR 10-2011032 (2019.08.08) KR 10-1779922 (2017.09.13)

The method of manufacturing a medical thread spun with a non-circular cross-section for manufacturing a non-functional suture of the present invention is to solve the problems occurring in the prior art as described above, and manufactures a thread provided for manufacturing a suture equipped with barbs. In doing this, the thread is divided into a core part, which is an area that is not damaged by cutting or pressing during barb forming, and a barb part where barb processing is performed, and the core part and barb part can be molded as one piece through extrusion processing, thereby performing barb processing. The purpose is to demonstrate the performance of the barb while minimizing damage to the core part.

In addition, the purpose is to enable the barb forming process to be easily performed by partially removing the barbs of the extruded thread by plucking rather than cutting or pressing.

In addition, as the thread is extruded into a non-circular cross-section, a groove is formed on the contact surface of the roller during the stretching process, and stretching is performed with the barb part inserted into the groove, so that the shape of the barb part of the final manufactured thread can be made constant. will be.

In order to solve the above-described problem, the method of manufacturing a medical barbed suture of the present invention involves melting and extruding a biodegradable polymer, cooling it, and then repeating heating and stretching to form a central core portion 11 and the core portion 11. ) and a thread manufacturing step of manufacturing a thread consisting of a barb portion 12 that is integrally connected to the core portion 11 and protrudes radially around the core portion 11; and a barb processing step of manufacturing a barbed suture provided with barbs by partially removing the specific barbed portion 12 of the thread by a predetermined length.

In the above configuration, the barb processing step is arranged radially surrounding the core portion 11 of the thread, and is 1/ of the angle formed by the two adjacent barb portions 12 with respect to the core portion 11. 2 It moves back and forth in the direction of the angle, and the inner peripheral surface is connected to the compression portion 310, which is configured to compress the barb portion 12, and corresponds to the shape of the barb portion 12. After positioning the thread inside the plurality of molds 300 consisting of the non-compressing portion 320 for non-compressing the barb portion 12, each mold 300 is moved to the center of the core portion 11 to form the barb portion 12. ) is characterized by processing by pressurizing.

In the above configuration, the barb processing step passes the thread through the plucking device 20 to pluck a specific barb portion 12, and the plucking device 20 is used to pluck each barb portion 12. A connecting portion (21a) formed in a round shape that surrounds the barbed portion (12) while being spaced apart from the other, and one side of the barbed portion (12) from both ends of the connecting portion (21a) while being integrally connected to the connecting portion (21a). Two extension parts (21c) extending in a direction surrounding the wall surface and the other wall surface, each having elasticity relative to the connecting part (21a), and each having a connecting pin through-hole (21b) formed in a straight line with each other, the extension part (21c) a plucking member (21) bent from the end of the portion (21c) toward the barb portion (12) and having a cutting portion (21d) whose end is made of a sharp blade; The body (22a) is fastened through the connecting pin through hole (21b) of the two extension parts (21c), and a head part (22b) with a larger diameter than the body is formed at the end of the two extension parts (21c). A connecting pin (22) that prevents separation of; a pressing member (23) whose one side is connected to the body (22a) of the connecting pin (22) and whose other side extends obliquely with respect to the extension portion (21c); A moving device (24) connected to the other side of the pressing member (23) and configured to move the other side of the pressing member (23) to cause one side of the pressing member (23) to move in a direction facing each other or in an opposite direction. It is characterized by being composed of ;.

In the above configuration, the thread manufacturing step is performed by supplying the biodegradable polymer in a molten state into the nozzle 100 of the extruder 1, which is provided with a nozzle 100 having a spinning hole 130 formed at the end. A biodegradable polymer is melt-extruded through the end of the spinning hole 130, wherein the spinning hole 130 communicates with the core forming part 131 having a circular cross-sectional shape and the core forming part ( 131) It consists of a barb forming portion 132 that protrudes radially outward, allowing the extruded filament 10 to form a core portion 11 having a circular cross-sectional shape and a barb portion protruding radially outward from the core portion 11. A melt extrusion step to form (12); A cooling step of cooling the filament 10 discharged from the nozzle 100 by passing it through a cooling water tank 2 storing cooling water; A stretching step of manufacturing a medical thread by heating and stretching the filament 10 that has gone through the cooling step through an oven 4 and a stretching roller 3.

In the above configuration, a barb insertion groove 31 into which the barb portion 12 of the filament 10 is inserted is formed on the surface of the stretching roller 3 to maintain the shape of the barb portion 12. It is characterized by

According to the present invention, when manufacturing a thread provided for manufacturing a suture equipped with barbs, the thread is divided into a core portion, which is an area that is not damaged by cutting or pressing during barb forming, and a barb portion where barb processing is performed, Extrusion processing allows the core and barbs to be molded as one piece, allowing the barb performance to be demonstrated while minimizing damage to the core during barb processing.

In addition, the barb forming process can be easily performed by partially removing the barbs of the extruded thread by plucking rather than cutting or pressing.

In addition, as the thread is extruded into a non-circular cross-section, a groove is formed on the contact surface of the roller during the stretching process, and stretching is performed with the barb portion inserted into the groove, so that the shape of the barb portion of the final manufactured thread can be made constant. .

Figures 1 and 2 are photographs and drawings showing the arrangement of the extruder, cooling water tank, oven, stretching roller, etc. for the process of the present invention.
Figure 3 is a cross-sectional view comparing the size and shape of the radiating hole of the cross-shaped nozzle and the manufactured thread in the present invention.
Figures 4 and 5 are cross-sectional schematic diagrams showing an example and operating state of the plugging device in the present invention.
Figure 6 is a cross-sectional view showing another example of the moving device of the plucking device.
Figure 7 is a partially cut perspective view specifically showing an example of a nozzle for melt extrusion in the present invention.
Figure 8 is a perspective view and an enlarged cross-sectional view showing an example in which a groove is formed to guide the barb portion inserted into the stretching roller in the present invention.
Figure 9 is a cross-sectional view comparing the size and shape of the radiating hole of the straight nozzle and the manufactured thread in the present invention.
Figure 10 is a photograph comparing the threads immediately after extrusion, stretching process, and manufacturing of the comparative example.
Figure 11 is a photograph comparing the threads immediately after extrusion, stretching process, and manufacturing of Example 1.
Figure 12 is a photograph comparing the suture of the present invention obtained by flocking a thread with barbs formed by extrusion molding and a suture formed by cutting circular cross-section yarn.
Figure 13 is a cross-sectional schematic diagram showing an example of barb processing using a plurality of molds moving toward a thread.
Figure 14 is a perspective view showing a specific example of the shape of the mold of Figure 13.

Hereinafter, the manufacturing method of the medical barbed suture of the present invention will be described in detail through the attached drawings.

1. Thread manufacturing steps

After melt-extruding the biodegradable polymer, cooling, heating and stretching are repeated to form a central core portion 11, which is integrally connected to the core portion 11 and protrudes radially around the core portion 11. A thread consisting of barbs 12 is manufactured.

1 and 2 show an extruder 1 for extrusion, a cooling water tank 2 for cooling, an oven 4 for heating and stretching, and a stretching roller 3 arranged in series.

In addition, Figure 3 shows an example of a thread consisting of a core portion 11 and a barb portion 12.

In the thread in the drawing, the barbed portion 12 is formed radially at an angle of 90 degrees with respect to the center of the core portion 11.

For this purpose, the radiation hole 130 provided in the nozzle of the extruder 1 is formed to correspond to the shape of the thread.

As shown in FIG. 3, the radiating hole 130 communicates with the core forming portion 131 having a circular cross-sectional shape and protrudes radially outward from the core forming portion 131. It consists of a barb forming part 132, and as shown in the drawing, the radiating hole 130 is formed to be large compared to the size of the thread to be manufactured.

2. Barb processing step

A barbed suture provided with barbs is manufactured by partially removing the specific barbed portion 12 of the thread by a predetermined length.

The method of partially removing the barbs 12 may be a conventionally known cutting method or a pressing method.

Among these, when applying the press method, as shown in FIGS. 13 and 14, a method using a mold 300 that operates simultaneously or selectively in four directions may be applied, unlike the prior art.

Looking at the drawing, the inside of the mold 300 is connected to the pressing part 310 and the pressing part 310 for compressing the barbed part 12, and the barbed part ( It consists of a non-compressed part 320 that non-compresses 12), and this mold reciprocates toward the center of the core part 11 in a direction that is 1/2 the angle formed by the two adjacent barbed parts 12. A mobile device 330 is connected.

That is, inside the box-shaped mold frame 340 for barb processing, four molds 300 are each moved forward and backward toward the center of the core portion 11 of the thread located inside the mold frame 340 by the moving device 330. It is installed to be movable, and its direction is inclined at 45 degrees with respect to the angle formed by the barb portion 12 and the core portion 11.

Looking at FIG. 13, each moving device 330 consisting of an actuator, etc. moves the molds 300 in the outer direction and the thread flows into the mold frame 340, and in this state, the moving device 330 moves the mold 300. ) is moved to the core portion (11).

In the drawing, all moving devices 330 are shown in an operating state, but the present invention is not limited to this, and each moving device 330 may be configured to move individually.

In addition, the arrangement of the compression portion 310 and the non-compression portion 320 of each mold 300 may be arranged to be symmetrical to each other, but is not limited to this, and may be arranged in various shapes to correspond to the barbed shape of the required suture. It may be configured to be the outer peripheral surface.

For example, Figure 14 (A) shows an example in which the compressed portion 310 and the non-compressed portion 320 are aligned in a straight line along the moving direction of the mold 300, and in (B) the compressed portion 310 is shown. An example is shown in which the barbs are formed inclined along the longitudinal direction so that the side cross-sectional shape of the barbs is inclined in a wedge shape.

However, in the case of threads spun with barbs 12 as in the present invention, it is somewhat unnecessary to pass a cutting device with a complex structure through a press device.

This is because conventional cutting devices or press devices have a very complicated structure to minimize damage to the center of the yarn, but in the present invention, since the barb portion 12 is formed in advance, there is no need to use a complicated device as in the prior art.

Accordingly, barbs can be easily formed by passing them through a plugging device 20 as shown in FIG. 4 and plugging a specific barb portion 12.

The illustrated plugging device is an example consisting of a plugging member 21, a connecting pin 22, a pressing member 23, and a moving device 24.

As shown, the plucking member 21 is spaced apart from each barb part 12 and is formed in a round shape surrounding the barb part 12, and is integrally connected to the connection part 21a. Connection pin through-holes (21b) extend from both ends of the connecting portion (21a) in a direction surrounding the one wall surface and the other wall surface of the barbed portion (12), have mutual elasticity with respect to the connecting portion (21a), and form a straight line with each other. ) is formed, respectively, and a cutting part 21d that is bent from the end of the extension part 21c toward the barbed part 12 and has a sharp blade at the end.

As shown, the connecting pin 22 has a body 22a fastened through the connecting pin through-hole 21b of the two extension parts 21c, and has a head portion 22b at the end having a larger diameter than the body. is formed to prevent separation of the two extension parts 21c.

One side of the pressing member 23 is connected to the body 22a of the connecting pin 22, and the other side is bent from one side and extends obliquely with respect to the extension portion 21c.

The moving device 24 is connected to the other side of the pressing member 23 and moves the other side of the pressing member 23 to cause one side of the pressing member 23 to move in a direction facing each other or in an opposite direction. consist of.

In the example shown in FIG. 4, the moving device 24 consists of a hydraulic or pneumatic actuator in which each pressing member 23 is rotatably connected to a rod.

When each actuator operates, the rod pushes or pulls the pressing member 23. When the rod is pulled, the pressing member 23 rotates as shown in Figure 5, and one side of it is inserted into the connecting pin 22 and extends. By pushing (21c), the two extension parts (21c) move in a direction facing each other, thereby plucking the barb part (12).

At this time, compared to FIG. 4, the plucking member 21 moves in a direction from the core portion 11 toward the barb portion 12 and tears off the barb portion 12.

In this state, when the actuator moves in the opposite direction, the extension portion (21c) moves in the opposite direction and the cutting portion (21d) moves to the outside of the barb portion (12).

Figure 6 shows another example of the mobile device 24.

The example in the drawing includes a first actuator 24a configured to move the rod horizontally, a second actuator 24b connected to the rod of the first actuator 24a and moving the rod in the vertical direction, and the second actuator 24b. ) is connected to the rod, and is composed of an operating piece 24c whose lower end selectively supports the pressing member 23 by the operation of the second actuator 24b.

In the example of the drawing, when the first actuator (24a) is operated while the operating piece (24c) is in contact with the pressing member (23) to move the rod in the outer direction of the drawing, the upper parts of the two pressing members (23) move away from each other. While moving in the opposite direction, the lower part is pressed so that the extension parts 21c face each other, thereby plucking the barbed part 12.

In this state, when the operating piece (24c) moves upward by the operation of the second actuator (24b), the external force of the pressing members (23) is released, and the plucking member (21) momentarily connects the two extension parts (24c) by elasticity. 21b) takes place.

The illustrated plugging device is a conceptual illustration for understanding the present invention, and the plugging device is not limited by the drawings.

The above configuration makes the production of barbed sutures much easier than before.

At this time, in the flocking process, if the width of the barb part 12 at the point where the barb part 12 and the core part 11 meet is too large, the flocking process may not be smooth and there is a risk that the core part 11 may be damaged. .

Also, on the other hand, if the width of the barbs 12 is too small, the suture may easily come out of the treatment area during the procedure.

In order to solve this problem, it is desirable that the thread manufacturing step proceeds as follows.

1-(1) Melt extrusion step

The extruder 1 shown in FIGS. 1 and 2 is equipped with a nozzle 100 having a radiation hole 130 formed at the end as shown in FIG. 7, and the radiation hole 130 is circular. It consists of a core forming part 131 forming a cross-sectional shape, and a barb forming part 132 that communicates with the core forming part 131 and protrudes radially to the outside of the core forming part 131.

At this time, the inner diameter (a) of the core forming part 131, the width (b) of the point where the barb forming part 132 and the core forming part 131 meet, and the barb forming part from the end of the core forming part 131 ( It is desirable that the length (c) to the end of 132) be in the ratio of 10:6.1 ~ 6.9: 4.1 ~ 6.7.

If the width (b) of the point where the barb forming part 132 and the core forming part 131 meet is less than 6.1, or the length (c) from the end of the core forming part 131 to the end of the barb forming part 132 If is less than 4, the width of the core portion 11 of the manufactured thread becomes too small, which ultimately means that the barb width becomes small, which causes the suture to easily come out of the skin tissue during the procedure.

Conversely, if the width (b) of the point where the barb forming part 132 and the core forming part 131 meet exceeds 6.9, the overall width (or diameter) of the suture to be manufactured is limited, so the core part (11) is on the opposite side. ) means that the diameter of the suture becomes smaller, which ultimately results in the suture breaking during the procedure because sufficient tensile strength of the suture is not secured.

In addition, if the width (b) of the point where the barb forming part 132 and the core forming part 131 meet exceeds 6.9, the barbed part 12 is connected when the barb part 12 is removed by partially cutting or compressing in the subsequent process. There is a problem in that the barb portion 12 cannot be easily cut because the area of the portion is large.

From another perspective, when four barbs 12 are formed at a 90-degree angle based on the core portion 11, that is, the width of the point where the barb formation portion 132 and the core formation portion 131 meet ( If b) exceeds 6.9, the core forming part 131 cannot be located at the point where the walls of adjacent barb forming parts 132 meet each other and is bent at a 90-degree angle, preventing smooth supply of raw materials to this part. This prevents the surface from being formed evenly during extrusion molding.

More preferably, when the thread is extruded in a cross shape, the inner diameter (a) of the core forming part 131, the width (b) of the point where the barb forming part 132 and the core forming part 131 meet, and the core forming part ( The length (c) from the end of 131) to the end of barb forming part 132 is preferably set to a ratio of 10: 6.1 to 6.4: 4.1 to 5.5,

When extruding a thread in a straight line (when two barbs are formed at an angle of 180 degrees), the inner diameter (a) of the core forming part 131 and the point where the barb forming part 132 and the core forming part 131 meet are The width (b) and the length (c) from the end of the core forming portion 131 to the end of the barb forming portion 132 are preferably 10:6.5 to 6.9:5.6 to 6.7.

Meanwhile, the nozzle 100 is composed of a head 110 provided with a spinning hole 130 and a support member 120 that attaches the head 110 to the extruder.

At this time, a seating groove 121 for seating the head 110 is formed in the support member 120, and a filtrate storage groove 122 is formed around the bottom of the seating groove 121.

This filtrate storage groove 122 is such that when the head 110 is coupled to the support member 120, the polymer remaining in the space where the polymer is supplied to the center of the support member 120 is connected to the coupling surface with the head 110. By allowing it to temporarily move to the filtrate storage groove 122 and be accommodated, the remaining polymer inside the support member 120 is prevented from blocking the inside of the head 110 or preventing smooth molding due to the residue. do.

1-(2) Cooling step

The filament 10 discharged from the nozzle 100 is cooled by passing it through a cooling water tank 2 in which cooling water is stored, as shown in FIGS. 1 and 2, etc.

The movement speed of the filament passing through the cooling water tank (2) is preferably about 2 to 7 m per minute.

1-(3) Stretching step

As shown in FIGS. 1 and 2, the filament 10 that has undergone the cooling step is heated and stretched through an oven 4 and a stretching roller 3 to manufacture a medical thread.

It is preferable that a plurality of ovens 4 and stretching rollers 3 are provided to repeat each other as shown.

At this time, the oven 4 maintains the temperature at about 90 to 170°C, and the appropriate moving speed of the filament is about 20 to 30 m per minute.

The manufactured filament is wound on the bobbin (5).

During the stretching process, the filament is stretched by the pulling force while receiving heat, and the cross-sectional area is reduced accordingly.

However, when stretched by heat, when the part in contact with the surface of the stretching roller (3) becomes the part between the barbs, the barbs are stretched by the pulling force, and the angle between the barbs becomes distorted, and the size and shape of each barb part change. This changing phenomenon occurs.

In order to suppress this phenomenon, as shown in FIG. 8, a barb insertion groove 31 is formed on the surface of the stretching roller 3 into which the barb part 12 of the filament 10 is inserted, so that the barb part 12 ) It is desirable to be able to maintain the shape.

At this time, as shown, the barb insertion groove 31 preferably has both walls rounded so that the barbs of the filament can be smoothly inserted.

Meanwhile, as shown in FIGS. 1 and 2, a plurality of ovens 4 and stretching rollers 3 are installed in succession along the direction of movement of the filament 10 to alternately and repeatedly heat and stretch the filament 10. It can be allowed to proceed, and at this time, it is preferable that the width and depth of the barb insertion groove 31 of each stretching roller 3 gradually decrease along the moving direction.

The thread 10 manufactured by the above manufacturing method has a diameter of the core portion 11 of 0.3 to 0.35 times the diameter of the core forming portion 131, and the diameter (d) of the core portion 11 ), the width (e) of the point where the barb part 12 and the core part 11 meet, and the length (f) from the end of the core part 11 to the end of the barb part 12 are 10: 3.8 ~ 5.5 : It is desirable to have a ratio of 3.5 to 4.0.

Specifically, when the radiating hole is formed in a cross shape, the manufactured thread 10 has a diameter of the core portion 11 of 0.3 to 0.32 times the diameter of the core forming portion 131, and the core portion 11 The diameter (d), the width (e) of the point where the barbs 12 and the core portion 11 meet, and the length (f) from the end of the core portion 11 to the end of the barbs 12 are 10. : 4.6 ~ 5.5 : 3.5 ~ 3.8 ratio,

When the radiating hole is formed in a straight line, the manufactured thread 10 has a diameter of the core portion 11 of 0.33 to 0.35 times the diameter of the core forming portion 131, and the diameter of the core portion 11 (d), the width (e) of the point where the barbs 12 and the core portion 11 meet, and the length (f) from the end of the core portion 11 to the end of the barbs 12 are 10:3.8. It is desirable to have a ratio of ~4.5:3.8~4.0.

Hereinafter, examples and comparative examples of the present invention will be described.

<Manufacturing Example 1> Manufacturing of thread using a nozzle equipped with a cross-shaped radiating hole

After manufacturing a nozzle equipped with a cross-shaped radiating hole with the specifications shown in Table 1 below, PDO (polydioxanone) as a biodegradable polymer raw material is supplied to the extruder shown in Figures 1 and 2 and melt-extruded under the condition of an extruder temperature of 180°C. After that, it was cooled by passing through a cooling water tank at a speed of 3 m per minute, and then repeatedly passed through an oven at 150°C and a stretching roller three times at a speed of 250 m per minute to manufacture medical threads.

division a b c a+(2c) a‘ b’ c’ division Example 1 1.6 One 0.7 3 10 6.25 4.38 cross
radiation hole Comparative Example 1 1.68 0.75 0.55 2.78 10 4.46 3.27 Comparative example 2 1.6 1.1 0.7 3 10 6.88 4.38 Comparative Example 3 1.32 0.82 0.84 3 10 6.21 6.36

(a: 'a' in Figure 3, b: 'b' in Figure 3, c: 'c' in Figure 3

b', c' are numbers representing the b and c values when all a values are set to the same 10)

The dimensions of the manufactured thread were measured and shown in Table 2 below.

division d e f d+(2f) d‘ e’ f’ division Example 1 0.50 0.27 0.18 0.85 10 5.34 3.61 cross Comparative Example 1 0.59 0.16 0.17 0.93 10 2.71 2.88 Comparative example 2 0.50 0.28 0.16 0.85 10 5.57 3.2 Comparative Example 3 0.46 0.24 0.20 0.85 10 5.32 4.37

(d: 'd' in Figure 3, e: 'e' in Figure 3, f: 'f' dimension in Figure 3

e', f' are the values of e and f when all d values are set to the same value of 10)

Looking at Tables 1 and 2, it can be seen that in Comparative Example 1, the width (e) and length (f) of the barbs 12 of the manufactured thread are both smaller than those of Example 1, so that the barbs easily come out during the procedure. You can.

In Comparative Examples 2 and 3, the width (e) and length (f) of the barbs 12 are larger than those in Comparative Example 1.

However, in the case of Comparative Example 2, the length f of the barbs 12 is so small that the barbs easily come out during the procedure, and in the case of Comparative Example 3, the core portion 11 is smaller than that of Example 1, so the tension of the thread itself is reduced. It can be seen that the strength decreases.

<Manufacturing Example 2> Manufacturing of thread using a nozzle equipped with a straight radiating hole

In addition, after manufacturing a nozzle equipped with a straight nozzle as shown in Table 3 below, a medical thread was manufactured in the same manner as Manufacturing Example 1.

division a b c a+2c a’ b’ c’ division Example 2 1.3 0.89 0.85 3 10 6.87 6.54 straight
radiation hole Comparative example 4 1.32 0.95 0.84 3 10 7.20 6.36 Comparative Example 5 1.27 0.81 0.87 3 10 6.38 6.81 Comparative Example 6 1.56 0.82 0.72 3 10 5.26 4.62

(a: 'a' in Figure 6, b: 'b' in Figure 36, c: 'c' in Figure 6

b', c' are numbers representing the b and c values when all a values are set to the same 10)

The dimensions of the manufactured thread were measured and shown in Table 4 below.

division d e f d+2f d’ e’ f’ division Example 2 0.45 0.18 0.18 0.80 10 3.98 3.97 straight
radiation hole Comparative example 4 0.45 0.18 0.16 0.77 10 4.06 3.59 Comparative Example 5 0.43 0.18 0.17 0.77 10 4.16 4.09 Comparative Example 6 0.52 0.18 0.11 0.75 10 3.44 2.17

(d: 'd' in Figure 6, e: 'e' in Figure 6, f: 'f' dimension in Figure 6

e', f' are the values of e and f when all d values are set to the same value of 10)

Looking at what is shown in Tables 3 and 4 above, in Comparative Examples 4 and 6, the length (f) of the barbs 12 is relatively small, so that the barbs can easily come out during the procedure. In Comparative Example 5, the length f of the barbs 12 is relatively small, so that the barbs can easily come out during the procedure. It can be seen that the tensile strength of the thread decreases as the diameter (d) decreases.

The appearance of the barbs of the threads manufactured in Preparation Example 1 and Preparation Example 2 was observed enlarged, and the results are shown in Table 5.

division detail Example 1 appropriate Example 2 appropriate Comparative Example 1 The barb width and length are small, uneven, and inappropriate. Comparative example 2 The barb width is large and uneven, inappropriate. Comparative example 3 The barb width and length are large, uneven, and inappropriate. Comparative example 4 The barb width is large, inappropriate. Comparative Example 5 Long barb length, inappropriate Comparative Example 6 Barb length is short, inappropriate.

Figure 10 shows the cross-section of the filament immediately after melt extrusion of Comparative Example 1, the cross-section of the filament after first stretching, and the cross-sectional shape of the thread after the stretching is completely completed.

Looking at the middle drawing of FIG. 10, it is shown that the end sides of the barbs 12 are all slightly curved, and looking at the lower drawing of FIG. 7, it can be seen that both the width and length of the barbs 12 are small. there is.

In this way, when the width (b) and length (c) of the initial barb forming portion 132 are small, the barb portion 12 tends to bend during the stretching process as well as after manufacturing, so that each barb portion 12 It can be seen that it does not have an even directionality and the cross-sectional shape is also uneven.

Figure 11 shows the cross-sectional shape of the filament immediately after melt extrusion, the filament after primary stretching, and the thread upon completion of manufacturing in Example 1.

As can be seen from the drawing, not only is the width and length of the barb portion 12 longer than that of Comparative Example 1, but its shape is also relatively straight and uniformly arranged radially.

Nevertheless, looking at the second drawing of FIG. 11, it can be seen that the shape of the barbs 12 is not completely symmetrical.

In this case, as shown in Figure 11, when the barb insertion groove 31 into which the barb part 12 of the filament 10 is inserted is formed on the surface of the stretching roller 3, the shape of the barb part 12 is uniform. can do.

<Manufacture Example 3> Manufacture of plugged thread

The suture of Example 1 was patched using the plugging device shown in FIG. 4.

In addition, after purchasing and preparing commercially available barbed sutures (yarn with a circular cross section cut), the cross section was enlarged and shown in Figure 12.

As can be seen from the drawing, the barbed suture according to the present invention has a constant shape of the core portion 11 and the barbs, while the conventional barbed suture has a non-uniform yarn surface (part other than the barbs). Able to know.

In other words, it can be seen that despite the fact that the plucking process was not performed using the same cutting method, it has the same or even more uniform appearance than the conventional one.

1: Extruder 2: Cooling water tank
3: Stretching roller 31: Barb insertion groove
4: Oven 5: Bobbin
10: Thread 20: Plucking device
21: Plucking member 21a: Connection part
21b: Connection pin through hole 21c: Extension part
21d: cutting part 22: connection pin
22a: body 22b: head part
23: pressurizing member 24: moving device
24a: first actuator 24b: second actuator
24c: Operation 11: Core section
12: barb part 100: nozzle
110: support member 120: head
121: Seating groove 122: Filtrate storage groove
130: Radiation hole 131: Core forming part
132: Barb forming part
300: Mold 310: Compression part
320: non-compressed part 330: moving device
340: Mold frame

Claims (5)

In the manufacturing method of medical barbed suture,
After melt-extruding the biodegradable polymer, cooling, heating and stretching are repeated to form a central core portion 11, which is integrally connected to the core portion 11 and protrudes radially around the core portion 11. A thread manufacturing step of manufacturing a thread made of barbed portions 12;
A barb processing step of partially removing the specific barbed portion 12 of the thread by a predetermined length to produce a barbed suture,

The thread manufacturing step is,
The biodegradable polymer is supplied in a molten state into the nozzle 100 of the extruder 1 equipped with a nozzle 100 with a spinning hole 130 formed at the end, and the biodegradable polymer is melted into the end of the spinning hole 130. When extruded, the radiating hole 130 includes a core forming part 131 having a circular cross-sectional shape, and a barbed forming part that communicates with the core forming part 131 and protrudes radially to the outside of the core forming part 131 ( 132), a melt extrusion step of forming the extruded filament 10 into a core portion 11 having a circular cross-sectional shape and a barbed portion 12 protruding radially outward from the core portion 11;
A cooling step of cooling the filament 10 discharged from the nozzle 100 by passing it through a cooling water tank 2 storing cooling water;
It consists of a stretching step of manufacturing a medical thread by heating and stretching the filament 10 that has gone through the cooling step through an oven 4 and a stretching roller 3,

Characterized in that a barb insertion groove 31 is formed on the surface of the stretching roller 3 into which the barb part 12 of the filament 10 is inserted, so as to maintain the shape of the barb part 12.

Method for manufacturing barbed sutures for medical use.
According to clause 1,
The scale processing step is,
It is arranged radially surrounding the core portion 11 of the thread, and moves forward and backward in a direction that is 1/2 the angle formed by the two adjacent barb portions 12 with respect to the core portion 11, and the inner peripheral surface is A compression portion 310 configured to compress the barb portion 12, and a non-compression portion connected to the compression portion 310 and corresponding to the shape of the barb portion 12 to non-compress the barb portion 12. After placing the thread inside a plurality of molds 300 consisting of 320, each mold 300 is moved to the center of the core portion 11 and the barb portion 12 is pressed and processed.
Method for manufacturing barbed sutures for medical use.
According to clause 1,
The barb processing step passes the thread through the plugging device 20 to plug a specific barb portion 12,
The plugging device 20,
A connection part (21a) formed in a round shape to surround the barb part 12 while being spaced apart from each barb part 12, and a barb from both ends of the connection part 21a while being integrally connected to the connection part 21a. Two extension parts ( 21c), and a plucking member 21 consisting of a cutting portion 21d bent from the end of the extension portion 21c toward the barb portion 12 and having a sharp blade at the end;
The body (22a) is fastened through the connecting pin through hole (21b) of the two extension parts (21c), and a head part (22b) with a larger diameter than the body is formed at the end, so that the two extension parts (21c) A connecting pin (22) that prevents separation of;
a pressing member (23) whose one side is connected to the body (22a) of the connecting pin (22) and whose other side extends obliquely with respect to the extension portion (21c);
A moving device (24) connected to the other side of the pressing member (23) and configured to move the other side of the pressing member (23) to cause one side of the pressing member (23) to move in a direction facing each other or in an opposite direction. Characterized by consisting of ;
Method for manufacturing barbed sutures for medical use.
delete delete