KR102564640B1 - Method for manufacturing hybrid medical thread manufactured using different materials - Google Patents

Abstract

A hybrid medical thread manufacturing method manufactured using different materials according to the present invention includes (a) inserting a first yarn between an ultrasonic generator and a mold base disposed adjacent to each other at a position corresponding to the pattern of the mold base step; (B) applying ultrasonic waves to the first yarn while pressing the first yarn through the ultrasonic generator; (c) inserting a second yarn on the first yarn generated in the shape of the pattern through ultrasonic waves; (d) applying ultrasonic waves to the second yarn while pressing the second yarn through the ultrasonic generator; (e) injecting the medical thread formed in the shape of the pattern while the first and second yarns are adhered through ultrasonic waves, wherein the medical thread has a body portion and a protrusion portion formed to have a plurality of protrusions facing each other on both sides. includes

Description

Hybrid medical thread manufacturing method made using different materials {METHOD FOR MANUFACTURING HYBRID MEDICAL THREAD MANUFACTURED USING DIFFERENT MATERIALS}

The present invention relates to a method for manufacturing a hybrid medical thread made of different materials.

Conventionally, medical thread was mainly used for suturing in surgery, and it lifts sagging skin and tissues such as the face, chin, neck, abdomen, vagina, chest, hip, etc. with a needle and thread without using a knife, and pulls and straightens wrinkles. As a technique that does not require excessive skin incision, can minimize the occurrence of scars, and has less bleeding or swelling due to surgery, it is in the limelight.

Natural materials and synthetic materials can be used. The material of natural absorbent medical thread is catgut, chromic, gut, etc., and the material of synthetic material absorbent medical thread is poly. Glycolic acid (Dexon, Mexone), polyglactin (Bicryl) and polydioxanone (PDS) have been used. Silk is used as the material for natural non-absorbent medical thread, and polyester (Dacron), polypropylene (Proline), polyamide (nylon) and e-PTFE (Gore) are used for synthetic non-absorbent medical thread. tex), etc.

Conventionally, it is used by forming protrusions on the surface of medical threads. In the existing manufacturing method, molding was performed through thermoforming or compression, which limited the surface of the threads or the formation of fine shapes, and fluff around the protrusions. Due to the nature of the PDO (Polydioxane) material, deformation occurs during thermoforming, and strength is weakened.

In particular, PDO melts at 109 degrees, lasts for 6-12 months, has good durability, spinous protrusions are easily caught on the skin, and maintains its shape well after being caught, but has the disadvantage of not being stretched well. In addition, PCL (polycaprolactone) melts at 60 degrees, lasts for 18-24 months, and has the advantage of being well stretched, but has a problem in that it is difficult to manufacture spinous processes because it is soft. That is, conventional medical threads have been formed with only a single material called PDO or PCL due to the above problems.

On the other hand, the conventional technique using ultrasonic waves is an ultrasonic welding technique, which attaches plastic materials through ultrasonic vibration. It is a technique in which the joint surface of the adhesive is melted and bonded, and strong molecular bonding is achieved.

A technique using ultrasonic waves used for industrial purposes is an ultrasonic welding technique as described above, and is not used for modifying the shape of a specific workpiece into a desired shape.

The present invention is to solve the above-mentioned problems of the prior art, and relates to an ultrasound-based medical thread manufacturing method for combining a PDO material and a PCL material used for medical purposes.

The present invention is an injection method using an ultrasonic generator with an ultrasonic output value set to 10 to 30 kHz to overcome the limitations of conventional medical threads (sutures) manufactured only from a single material, and to manufacture a hybrid medical thread combining PDO and PCL. Its purpose is to provide a method.

A hybrid medical thread manufacturing method manufactured using different materials according to the present invention includes (a) inserting a first yarn between an ultrasonic generator and a mold base disposed adjacent to each other at a position corresponding to the pattern of the mold base step; (B) applying ultrasonic waves to the first yarn while pressing the first yarn through the ultrasonic generator; (c) inserting a second yarn on the first yarn generated in the shape of the pattern through ultrasonic waves; (d) applying ultrasonic waves to the second yarn while pressing the second yarn through the ultrasonic generator; (e) injecting the medical thread formed in the shape of the pattern while the first and second yarns are adhered through ultrasonic waves, wherein the medical thread has a body portion and a protrusion portion formed to have a plurality of protrusions facing each other on both sides. includes

The medical thread includes a first layer made of a first yarn and a second layer made of a second yarn, and the first layer and the second layer are distinguished by mutually different colors.

The first yarn is formed of PCL (polycaprolactone) material, and the second yarn is formed of PDO (Polydioxane) material.

The frequency of the ultrasonic waves generated by the ultrasonic generator is 10 to 30 kHz.

The pattern is composed of a combination of one or more intaglio patterns and one or more embossed patterns.

As the molecules constituting the first yarn are vibrated through ultrasonic waves, the first yarn in a solid state is melted to create a first layer corresponding to the pattern.

As the molecules constituting the second yarn are vibrated through ultrasonic waves, the second yarn in a solid state is melted to create a second layer corresponding to the pattern, and a medical thread is manufactured.

In one embodiment of the present invention, in manufacturing a medical thread used for a lifting procedure, it is difficult to bond materials having different characteristics into one because conventional medical threads have different properties such as melting point and strength, and thus a single material such as PDO or PCL problems can be solved only by

In addition, since all the advantages of different materials can be acquired, medical threads with high tensile strength and retention can be manufactured, and high satisfaction can be expected.

1 is a flowchart illustrating a method for manufacturing a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.
2A and 2B are diagrams illustrating patterns of a manufacturing apparatus and a mold base for manufacturing hybrid medical threads manufactured using different materials according to an embodiment of the present invention.
3 is a perspective view of a medical thread manufactured through a method for manufacturing a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.
4 is an enlarged view illustrating a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.
5 and 6 are views for explaining experiments using hybrid medical threads manufactured using different materials according to an embodiment of the present invention.

Since the present invention can have various changes and various forms, implementations (or examples) will be described in detail in the text. However, this is not intended to limit the present invention to a specific form disclosed, and should be understood to include all modifications, equivalents, or substitutes included in the spirit and scope of the present invention.

Throughout the specification, when a part is said to be "connected" to another part, this includes not only the case where it is "directly connected" but also the case where it is "electrically connected" with another element interposed therebetween. . In addition, when a certain component is said to "include", this means that it may further include other components without excluding other components unless otherwise stated.

In addition, the components in each drawing are expressed in exaggeratedly large (or thick) small (or thin) or simplified expressions in size or thickness in consideration of convenience of understanding, etc., but the scope of protection of the present invention is thereby limited. It shouldn't be.

Terms used in this specification are only used to describe a specific embodiment (aspect, aspect, aspect) (or embodiment), and are not intended to limit the present invention. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this application, terms such as ~comprising~ or ~consisting of are intended to designate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, but one or more other features It should be understood that it does not preclude the possibility of the presence or addition of numbers, steps, operations, components, parts, or combinations thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related art, and unless explicitly defined in the present application, they should not be interpreted in an ideal or excessively formal meaning. don't

The present invention relates to a method for shaping a thread (suture) used for medical purposes to suit its purpose using ultrasonic waves.

1 is a flowchart illustrating a method for manufacturing a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.

2A and 2B are diagrams illustrating patterns of a manufacturing apparatus and a mold base for manufacturing hybrid medical threads manufactured using different materials according to an embodiment of the present invention.

In this specification, the thread used for medical purposes is expressed as a medical thread. However, the thread refers to the same object conventionally expressed as a COG thread, a surgical thread, a medical thread, or a suture thread.

As shown in FIG. 2A, the thread manufacturing apparatus 100 according to an embodiment of the present invention includes an ultrasonic generator 110 that generates ultrasonic waves and presses yarn, and a mold in which a medical thread shape is engraved with an intaglio pattern 121. A base 120 may be included.

In addition, the yarn insertion unit 130 for inserting yarn and the yarn ejection unit 140 for discharging yarn may be provided in the form of rollers to be rotatable.

At this time, the yarn 10 is fixed through the yarn insertion unit 130 and the yarn ejection unit 140, and rotates in one direction to move the yarn 10. Here, a detailed description of the ultrasonic generator 110 will be described later.

Meanwhile, another type of yarn manufacturing apparatus having the same configuration as the yarn manufacturing apparatus 100 shown in FIGS. A medical thread may be manufactured according to the fabricated hybrid medical thread manufacturing method.

The intaglio pattern 121 mentioned below means the shape of the pattern shown in FIG. 2B.

Additionally, although only the intaglio pattern 121 is formed in FIG. 2B, one or more intaglio patterns 121 and one or more embossed patterns may be additionally provided. That is, when the yarn is manufactured through the most central intaglio pattern 121, one or more embossed patterns (not shown) and intaglio patterns (not shown) are additionally provided on both sides of the middle intaglio pattern 121, so that the device It may be configured to slightly space the intaglio pattern 121 between the body portion of the structure and the center.

Hereinafter, a method for manufacturing a hybrid medical thread manufactured using different materials according to the present invention will be described in detail with reference to the accompanying drawings.

Referring to FIGS. 1 to 2B , a method for manufacturing a hybrid medical thread manufactured using different materials according to an embodiment of the present invention is between an ultrasonic generator 110 and a mold base 120 disposed adjacent to each other. Inserting a first yarn into a position corresponding to the pattern of the mold base 120 in (S110), applying ultrasonic waves to the first yarn while pressing the first yarn through the ultrasonic generator 110 (S120), Inserting a second yarn on the first yarn generated in the shape of the pattern through ultrasonic waves (S130), applying ultrasonic waves to the second yarn while pressing the second yarn through the ultrasonic generator 110 (S140) and The first yarn and the second yarn are adhered through ultrasonic waves and simultaneously injecting the medical thread generated in the shape of the pattern (S150).

3 is a perspective view of a medical thread manufactured through a method for manufacturing a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.

As shown in FIG. 3, the medical thread may include a body portion 101 and a protrusion portion 102 formed to have a plurality of protrusions facing each other on both sides.

Illustratively, the protruding portion 102 of the medical thread may be manufactured to have a predetermined thickness. In addition, the mold base 120 may be formed such that a transverse cross section or a longitudinal cross section of the protrusion 102 has a rectangular shape.

When viewed from the side, one side of the protrusion 102 may be formed in a rectangular shape, and left and right may be symmetrical.

The protrusion 102 is created by extending from the body 101 of the thread, and as shown, is formed in a triangular shape, and the longest side of the protrusion 102 and the interior angle formed by the body 101 are formed as an acute angle. And, the inner angle formed by the shortest side of the protrusion 102 and the body portion 101 may be formed as an obtuse angle so that the protrusions face the center.

4 is an enlarged view illustrating a hybrid medical thread manufactured using different materials according to an embodiment of the present invention.

As shown in FIG. 4, the medical thread includes a first layer 10b made of a first yarn and a second layer 10a made of a second yarn, the first layer 10b and the second layer 10a They can be distinguished by mutually different colors. This is just an example, and the first layer 10b and the second layer 10a may have the same color as each other.

For example, the first yarn may be formed of a polycaprolactone (PCL) material, and the second yarn may be formed of a polydioxane (PDO) material.

In step S120, the first layer 10b corresponding to the pattern may be created by melting the first yarn in a solid state by vibrating the molecules constituting the first yarn through ultrasonic waves. Accordingly, the first yarn is composed of a thin cylindrical thread, but as the solid properties of the edge portion of the first yarn become closer to the liquid properties by ultrasonic waves, the empty space constituting the frame of the intaglio pattern is formed by the first yarn It can be formed according to the shape of the intaglio pattern while filling it.

Subsequently, a second yarn is placed on the first layer 10b generated in step S140, the mold is closed, and the molecules constituting the second yarn are vibrated through ultrasonic waves to melt the second yarn in a solid state and pattern the pattern. A second layer 10a corresponding to may be created. Accordingly, a medical thread made of the first layer 10b and the second layer 10a corresponding to the pattern can be manufactured.

That is, the shape modification of the first and second yarns is achieved by changing the physical properties of the yarns in a solid state by vibrating the molecules constituting the yarns through ultrasonic waves, and through this process, the medical thread that fits the intaglio pattern 121 can be manufactured.

Referring to FIG. 4, the shape of the hybrid medical thread manufactured using different materials according to the present invention will be described in detail.

FIG. 4(a) shows a region of a medical thread in which the body 101 having a pair of protrusions 102 facing each other is enlarged, and FIG. 4(b) is shown in FIG. 4(a) This is a cross section obtained by cutting the cross section of the body portion 101 in which the pair of protrusions 102 are formed.

For example, as shown in FIG. 4(b), the first layer 10b and the second layer 10a may be formed on lower and upper sides based on a horizontal line dividing the circular body portion 101 in half. can In other words, the first layer 10b is disposed on the lower side with respect to the horizontal line, and the body portion 101 and the protruding portion 102 constituting the lower side of the medical thread may be made of PCL. Similarly, the second layer 10a is disposed on the upper side with respect to the horizontal line, and the body portion 101 and the protrusion portion 102 constituting the upper side of the medical thread may be formed of PDO. At this time, the lower side of the medical thread is not limited to PCL and the upper side is composed of PDO. As the insertion order of the first and second yarns is changed in the method of manufacturing the medical thread of the present invention, the lower side of the medical thread is formed of PDO. and the upper side may be composed of PCL.

Specifically, referring to FIGS. 2A and 2B , the ultrasonic generator 110 is formed at the upper end of the seal manufacturing apparatus 100 and may be positioned apart from the mold base 120 fixed to the ground.

At this time, the ultrasonic generator 110 and the mold base 120 are configured in a flat plate shape and may be arranged to share a central axis. That is, they have the same central axis and may be arranged side by side in one direction.

Illustratively, when the first and second yarns are inserted, the ultrasonic generator 110 generates ultrasonic waves while descending as far as the distance that can come into contact with the mold base 120 to generate ultrasonic waves while pressing the inserted yarn 10. can go

In addition, the first or second yarn 10 is inserted through the yarn insertion portion 130, and is inserted and fixed so as to correspond to the area where the intaglio pattern 121 of the mold base 120 is located, and the first and second yarns 10 are inserted and fixed. The width of the binary yarn 10 may be wider than the width of the intaglio pattern 121 .

When the first and second yarns 10 are positioned on the intaglio pattern 121 of the fixed mold base 120, the above-described ultrasonic generator 110 operates and a medical thread can be created.

At this time, the frequency of the ultrasonic waves emitted by the ultrasonic generator 110 may be 10 to 30 kHz.

In particular, the first yarn made of PCL material melts at 60 degrees Celsius, lasts for 18 to 24 months, and has the advantage of being stretched well, but has difficulty in producing protrusions because it is soft. In addition, the second yarn made of PDO material melts at 109 degrees Celsius, lasts for 6 to 12 months, has good durability, protrusions easily catch on the skin, and has the advantage of maintaining its shape with a certain strength even after being caught, but has the disadvantage of not stretching well.

That is, in the case of PDO and PCL, if too much energy is applied, they are melted or broken, and if too little energy is applied, the yarn is not melted (the physical properties of the yarn are not deformed), so it is not manufactured according to the pattern of the mold base 120 , there was a problem that PCL and PDO did not adhere to each other. Therefore, conventionally, due to the difficulty in manufacturing a medical thread in which two or more materials having different characteristics are mixed, it has been formed with only a single material such as PDO or PCL.

However, according to the method for manufacturing hybrid medical threads manufactured using different materials of the present invention, when ultrasonic waves are applied to the first and second yarns by setting the ultrasonic output value to 10 to 30 kHz, PDO and PCL are melted or broken. The physical properties of PDO and PCL are appropriately melted without losing, and a medical thread can be manufactured to fit the pattern 121 of the mold base 120. At the same time, the PDO and the PCL are firmly bonded to manufacture a medical thread in which the first and second yarns are integrally formed.

5 and 6 are views for explaining experiments using hybrid medical threads manufactured using different materials according to an embodiment of the present invention.

Hereinafter, with reference to FIGS. 5 and 6, results of tensile strength and elongation test of medical threads manufactured according to the hybrid medical thread manufacturing method using different materials of the present invention will be described.

Test items for the medical thread according to an embodiment of the present invention are shown in Table 1 below.

[Table 1]

Measurement equipment for medical thread according to an embodiment of the present invention is shown in Table 2 below.

[Table 2]

A test environment for a medical thread according to an embodiment of the present invention is shown in Table 3 below.

[Table 3]

Test samples for medical threads according to an embodiment of the present invention are shown in Table 4 and FIG. 5 below.

[Table 4]

Standard information on the test sample for the medical thread according to an embodiment of the present invention is shown in Table 5 and FIG. 6 below.

[Table 5]

Table 6 below shows information on the basis of tensile load reference values for medical threads according to an embodiment of the present invention.

[Table 6]

That is, it can be seen that the diameter 2 (widened diameter) after forming the yarn (0.60 mm) after molding is 1.00 mm, and the diameter 2 (widened diameter) after forming the spine is 0.40 mm.

The measurement results of the tensile strength and elongation test for the medical thread according to an embodiment of the present invention are shown in Table 7 below. Tensile strength is an important factor in determining the performance of medical thread. This is because it can be inserted into the body and perform a function of firmly fixing or connecting tissue to tissue when the tensile strength is higher than a predetermined level.

[Table 7]

When manufacturing a medical thread mixed with PDO and PCL according to the present invention, the ultrasonic output value was increased at intervals of 5 KHz within the range of 5 KHz to 35 KHz to manufacture a total of 7 divided medical threads.

At this time, referring to the measurement results according to the tensile strength and elongation test of the samples prepared by each ultrasonic output value in Table 7, it indicates that the diameter average including the generated thorns after processing is different from the reference value (1.00).

In particular, looking at the results of the knot tensile load average criterion (N), the tensile load average criterion (N) of 35.7 or more and 47.0 or less at 10KHz to 30KHz is shown, and the tensile load average criterion (N) of 27.6 and 26.7 shown at 5KHz and 35KHz ) is significantly higher than that of

Similarly, looking at the elongation test (%) results, it can be seen that the elongation (%) of 11.3 or more and 15 or less at 10KHz to 30KHz is significantly higher than the elongation (%) of 7.4 and 6.1 at 5KHz and 35KHz. there is. It can be seen that the difference is larger than the difference between the input frequencies and the tensile strength is different.

That is, since the ultrasonic output value shows a significantly higher value than the tensile strength value / tensile load average standard / elongation test value within the numerical range of 10KHz to 30KHz, it has critical significance.

In addition, the present invention can be manufactured to have projections twice as large as conventional medical threads, and can solve the factor of deterioration in physical strength by not scratching or knotting the yarn by using ultrasonic waves.

Due to this, more effective efficacy can be expected in the lifting procedure, and it can be fixed and maintained more firmly than conventional products.

Compared to the conventional method of cutting with heat and mold pressure, ultrasonic vibration can be applied to the material and the particles can be put into the mold of the ultrasonic mold to create cog shapes and various three-dimensional shapes.

Conventional yarn is heated, the heated yarn is flattened with a roller, and the flattened yarn is cut into a mold shape by applying pressure to a mold. As heat is applied to the yarn, the volume and density of the material expand, and the physical properties of the raw material are reduced to about 30%. When a flat thread that has been weakened to the extent of a professional and expanded by heat is pressed and cut with a cog-shaped mold, fluff is formed at the end of the cog and it is difficult to implement the sharp end of the cog. It is placed in a mold and minimizes heat or artificial stimulation in a short time by ultrasonic vibration, so there is almost no denaturation of yarn raw materials, and the existing ability of strength and physical properties can be maintained.

The above description of the present invention is for illustrative purposes, and those skilled in the art can understand that it can be easily modified into other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, the embodiments described above should be understood as illustrative in all respects and not limiting. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined form.

The scope of the present invention is indicated by the following claims rather than the detailed description above, and all changes or modifications derived from the meaning and scope of the claims and equivalent concepts should be interpreted as being included in the scope of the present invention. do.

100: yarn manufacturing device 10: yarn
110: ultrasonic generator 120: mold base
121: intaglio pattern
130: yarn insertion unit 140: yarn ejection unit

Claims (7)

In the hybrid medical thread manufacturing method manufactured using different materials,
(a) inserting a first yarn at a position corresponding to the pattern of the mold base between the ultrasonic generator and the mold base disposed adjacent to each other;
(b) applying ultrasonic waves to the first yarn while pressing the first yarn through the ultrasonic generator;
(c) inserting a second yarn onto the first yarn generated in the shape of the pattern through the ultrasonic waves;
(d) applying ultrasonic waves to the second yarn while pressing the second yarn through the ultrasonic generator;
(e) injecting the medical thread generated in the shape of the pattern at the same time as the first and second yarns are bonded through the ultrasonic waves;
The medical thread includes a body portion and a protrusion portion formed to have a plurality of protrusions facing on both sides,
The medical thread includes a first layer made of the first yarn and a second layer made of the second yarn,
The first layer and the second layer are distinguished by mutually different colors and are disposed on the lower and upper sides based on a horizontal line divided in half with respect to the cross-sectional area of the medical thread,
The first yarn is made of a PCL (polycaprolactone) material, and is formed of a body portion and a protrusion portion constituting the first layer of the medical thread,
The second yarn is made of a PDO (Polydioxane) material, and is formed of a body portion and a protrusion portion constituting the second layer of the medical thread,
The frequency of the ultrasonic waves generated by the ultrasonic generator is 10 to 30 kHz,
Method for manufacturing medical thread.
delete delete delete According to claim 1,
The pattern is
Consisting of a combination of one or more intaglio patterns and one or more embossed patterns,
Method for manufacturing medical thread.
According to claim 1,
Generating the first layer corresponding to the pattern by melting the first yarn in a solid state by vibrating the molecules constituting the first yarn through the ultrasonic wave,
Method for manufacturing medical thread.
According to claim 1,
Melting the second yarn in a solid state as the molecules constituting the second yarn are vibrated through the ultrasonic waves to create the second layer corresponding to the pattern and to manufacture the medical thread,
Method for manufacturing medical thread.

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