• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    MEDICAL SUTURE WITH MICRO TEETH ON THE SURFACE AND METHOD OF MANUFACTURING THE SAME. A medical suture provided with micro teeth on the surface of the same and a method of making the medical suture is provided. The method of making the medical suture includes the steps of: producing the suture preform where micro teeth are formed on the surface of the suture by heating and pressing the raw material of the suture for surgery in an overflow mold in a method of forming solid heat pressure phase; and producing the maintained twisted suture by applying a tensile force and a rotational force to the suture preform in a vacuum state where a specific temperature condition is maintained.
    公开号:BR112012021922B1
    申请号:R112012021922-7
    申请日:2011-08-29
    公开日:2020-11-10
    发明作者:Tae Jun Kim；Byung Gwan Kim；Daesung Song
    申请人:Hansbiomed Corp.；
    IPC主号:
    专利说明:

    Background of the Invention Field of the Invention
    The present invention relates to a medical suture with micro teeth on its surface and a method of making the medical suture. Description of the Related Art
    From the second half of the 1960s, in order to finish suturing tissues without tying the suture, a barbed suture endowed with splinters that are formed when cutting an external portion of the suture was attempted to be used to suture tissue. In barbed suture, one or more micro teeth are formed on the surface of the suture at a predetermined interval. If the suture is inserted in one direction and tension is applied to pull the suture in the opposite direction, the splinters formed on the surface of the suture are firmly engaged with the tissue. Therefore, unlike the general suture, the barbed suture is used without tying.
    In the 1990s, Ruff in North Carolina of US and Sulamanidze in Russia published a new form of a barbed medical suture that can be used for surgical suture, plastic surgery to remove wrinkles on the face, neck, chest, and the like or traction of facial tissue, and plastic surgery to remove wrinkles. In addition to the barbed suture, several medical sutures for anchoring tissue were used for two purposes, namely, knot-free and plastic sutures.
    As a manufacturing method representative of the barbed suture for surgical tissue suture and plastic surgery, cutting methods are described in US Patent No. 2004/0060410 entitled "Barbed Suture" and US Patent No. 2003/0041426 entitled "Method of Forming Barbs in a Suture and Apparatus for Performing Same ". The cutting method is now widely used, and most suture products are manufactured according to the cutting method. However, the cutting method has the following drawbacks. Since splinters are formed by cutting the surface of a spun thread from the suture, there is a limitation in size and thickness of the splinter; since the distal end of the splinter is very sharp, the stimulus can be exerted on tissues or nerves in its vicinity; since the spun thread of the suture is damaged by cutting, its strength is greatly reduced compared to the suture with the same size; and since the bio-absorption of relatively thin splinters formed by the cutting method is carried out faster, the ability to anchor to the tissue is easily lost.
    In order to compensate for the structural inconveniences in barb formation, US Patent No. 7,582,105 describes "Suture for Wound Closure, Tissue Approximation, Tissue Support, Suspension and / or Anchoration". In the present invention, splinters are not formed in the suture, but the suture is tied with a predetermined interval, and a cone is suspended in each node. However, in the present invention, since the knots are formed in the suture, excess folds and curves are formed in the suture, and thus, the resistance is greatly reduced in the knots, so that the function as a suture can be lost. Additionally, the cone suspended from each node is larger and more rigid than the barb. When the suture is inserted into the subcutaneous tissue, a patient may experience great pain due to damage to tissues and nerves.
    In addition, US Patent No. 2006/005144 entitled "Tissue Holding Devices and Methods for Making the Same" describes a method of cutting and pressing and an injection molding method as mentioned techniques. However, the implementation of the present invention is not guaranteed, and the present invention is not yet commercialized.
    As described above, although several methods have been used to manufacture the medical suture with a tissue anchoring function, techniques to compensate for some drawbacks of current products and capable of being immediately marketed and practically used were necessary to be developed. Summary of the Invention
    The present invention is to provide a medical suture with micro teeth on its surface that can be effectively used for surgical administration and a medical suture manufacturing method.
    In accordance with an aspect of the present invention, a medical suture manufacturing method is provided including: (1) producing a suture preform where micro teeth are formed on the surface of the suture when heating and pressing a raw material from a suture to surgery on an overflow mold at a temperature condition from a point less than the melting point of the raw material of the suture to a point greater than the glass transition temperature at a pressure condition from 10 kgf / cm2 to 200 kgf / cm2 in a heat pressure solid phase formation method; and (2) produce a twisted suture maintained by heating the suture preform and applying a tensioning force and a rotational force to the suture preform in a vacuum state where the temperature condition from a lower point than the melting point of the raw material of the suture to a point greater than the glass transition temperature is maintained.
    In accordance with another aspect of the present invention, a medical suture manufactured according to the aforementioned method is provided, in which cutting angles are not formed on the surface of the suture and the micro teeth are formed on the surface of the suture, in which rotation per unit length of the suture is applied in a range from 72 ° / cm to 360 ° / cm, and in which the micro tooth has a directivity and has an anchoring capacity by which the soft tissue is anchored in an opposite direction to an insertion direction when the suture is inserted into the soft tissue.
    According to the present invention, it is possible to provide a medical suture with micro teeth on its surface.
    In the medical suture in accordance with the present invention, its tensile strength is at a level of from about 80% to about 90% of the tension resistance of a spun suture thread, and micro teeth provided with several shapes and size can be formed on the outer side of the suture.
    According to the present invention, the micro tooth has a directivity, so that the micro tooth has an anchoring force to anchor tissue in a direction opposite to an insertion direction when the suture is inserted into the tissue. Since the micro tooth can be formed in different shapes and sizes, biological and mechanical tissue reactions that occur during insertion into the soft tissue can be designed in an optimized way.
    According to the present invention, it is possible to solve a problem of tissue disintegration phenomenon in the related technique in the case where the medical suture with bioabsorbable property to anchor tissue is inserted into the tissue. That is, in this case, in the related technique, since anchors (barbs, teeth, protuberances, conical hats) endowed with the anchoring function in the opposite direction to the insertion direction are absorbed in the body, the resistance is greatly weakened and the function of tissue anchoring is lost, so that the phenomenon of tissue disintegration occurs. According to the present invention, since the size of the anchor (micro tooth) can be adjusted, the time taken to completely dissolve the micro tooth can be extended. Therefore, the time when the tissue anchoring force is weakened can be delayed, and the initial anchoring force can be increased. Therefore, it is possible to manufacture a medical suture endowed with bioabsorbable property, anchoring tissue, and being suitable for plastic. Brief Description of Drawings
    Figure 1 (a) is a view illustrating an overflow mold according to an embodiment of the present invention, and Figure 1 (b) is a view illustrating an image thereof.
    Figures 2 (a) and 2 (b) are seen illustrating images of the suture preform as a primarily formed product produced by a pressure and heat formation method in accordance with the present invention, and figure 2 (c) is a view illustrating a deformation image of a polymer suture during a pressure formation process.
    Figure 3 is a view illustrating a graph of resistance to the tension of suture threads produced by the cutting method (companies A, B, and C) and the resistance to tension of a suture thread produced by a method according to the present invention.
    Figure 4 (a) is a view illustrating an image of the barbed suture produced by a cutting method, and figure 4 (b) is a view illustrating an image of the medical suture with micro teeth on its surface produced in accordance with the present invention. Description of Preferred Modalities
    Hereafter, a method of making the medical suture will be described in detail.
    First, in step (1), the raw material of the suture is heated and pressed under the condition of specific temperature and pressure by a solid phase formation method, so that a suture preform with micro teeth on the surface of the it is produced.
    Step (1) is based on the molecular orientation and thermal properties of the raw material of a surgical suture produced from medical grade polymers (hereinafter, referred to as a polymer suture). The polymer suture has directional molecular orientation in an internal portion of it. Because of the directional molecular orientation, the polymer suture can maintain high tensile strength. However, in the case where the polymer suture is heated in a range from the melting point to a point of 30 ° C less than the melting point (Tm ~ Tm-30 ° C), the ductility of the polymer suture is increased or shrinkage deformation occurs, so that the molecular orientation is lost. Additionally, the resistance to tension needed to suture tissue is lost.
    However, although the polymer suture is in the heating range, in the case where the polymer suture is heated in the same range after the two ends are fixed so that the polymer suture is not retracted and deformed, the ductility of the polymer suture is increased, and the tensile strength is maintained at the same level as that of the spun thread of the polymer suture.
    The present invention uses the properties above the polymer suture. The ductility is increased by heating the spun yarn of the polymer suture to a specific temperature lower than the melting point of the raw material of the polymer suture; and micro teeth are formed on the surface of the polymer suture by pressing the polymer suture in the state where the two ends of the suture are fixed in order to suppress shrinkage deformation. In this case, micro teeth can be formed on the surface of the spun yarn while the molecular orientation of the polymer suture is maintained.
    According to the present invention, the raw material of the medical suture is a medical polymer endowed with bioabsorbable property. More specifically, for example, poly-dioxanone, poly- (1-lactic) acid, poly-glycolic acid, and copolymers thereof can be selectively used. In the case of using the medical polymer endowed with bioabsorbable property, a medical suture endowed with bioabsorbable property can be manufactured.
    Additionally, the raw material of the medical suture can be a medical polymer with a non-bioabsorbable property. More specifically, for example, polypropylene, nylon, and mixtures thereof can be selectively used. In the case of using the medical polymer with non-bioabsorbable property, a medical suture with non-bioabsorbable property can be manufactured.
    In the present invention, an overflow mold is used to manufacture the suture preform. The overflow mold is configured to include a training space and an overflow space. The formation space and the overflow space can be partitioned by a partition wall whose thickness does not exceed 60 pm. Preferably, the space between the forming space and the overflow space of the overflow mold is in a range from 30 pm to 60 pm. In the case where the space between the forming space and the overflow space is large in order to exceed 60 pm, there is a problem in the sense that, after pressure formation, a product is not easily separated from a burr.
    An introduction portion of the overflow space is configured to have an angle from 45 ° to 90 °, more preferably, 80 °. If the angle of the introduction portion of the overflow space is less than 45 °, high pressure is required for pressure forming, and there is a tendency that, after forming, the product is not easily separated from the burr. If the angle of the introduction portion of the overflow space is greater than 90 °, there is a problem in the sense that the mold forming portion is weakened.
    The depth of the overflow space is controlled so that the depth of the overflow space is not greater than the depth of the formation space. Preferably, the depth of the overflow space is in a range from 50 pm to 100 pm. More preferably, the depth of the overflow space is adjusted to 100 µm so that the product can be easily separated from the burr.
    The width of the overflow space is formed along the boundary line with respect to the formation space. The width of the overflow space is in a range from 250 pm to 500 pm. Most preferably, the width of the overflow space is 500 pm. If the width of the overflow space is large so as to exceed the above range, there is a problem in the sense that the pressure applied to the overflow mold is increased, so that the durability of the forming portion is weakened.
    If the overflow space has a size in the bands described above, after heating and forming by pressing the medical suture, the burr that occurs on the surface can be removed. If the overflow space has a size exceeding the ranges described above, the burr cannot be easily removed from the product, so the medical suture cannot be manufactured.
    Figure 1 (a) is a view illustrating an overflow mold according to an embodiment of the present invention, and Figure 1 (b) is a view illustrating an image thereof. As illustrated in figure 1, if the forming space and the overflow space of the overflow mold are configured to satisfy the conditions, the desired suture can be obtained.
    The temperature used in the aforementioned step (1) is a specific temperature within the temperature range from a point less than the melting point of the raw material of the suture to a point greater than the glass transition temperature. Preferably, the temperature is in a range from a point of 30 ° C less than the melting point (Tm-30 ° C) to a point of 15 ° C less than the melting point (Tm-15 ° Ç).
    In the above step, in the case where the temperature is room temperature, due to the elasticity of the polymer suture, compression and expansion occur during pressure formation. In other words, in the case where the polymer suture is pressed and formed at room temperature by a strong force, when the compression force is applied, the forming space is temporarily filled. When the compression force is removed, some portion is expanded to be recovered, so that the burr portion between the molds is retracted. Therefore, the format of the product becomes different from the format of the training space.
    In the present invention, in order to overcome the said problem, the temperature during heating and pressing is adjusted to be within the temperature range from a point less than the melting point of the raw material of the suture to a point greater than the glass transition temperature.
    On the other hand, in step (1), the pressure applied to the overflow mold is in a range from 10 kgf / cm2 to 200 kgf / cm2, more preferably, in a range from 80 kgf / cm2 to 160 kgf / cm2. Additionally, pressing can be appropriately used in a range from 15 ton to 50 ton. If the pressure is low (less than the lower limit of the above range), the burr is not removed from the overflow mold, there is a tendency for the medical suture to be difficult to manufacture. If the pressure is high (more than the upper limit of the above range), the durability of the mold is weakened, so that the forming portion can be deformed.
    The suture preform is produced as a product primarily formed by heating and pressure forming in the state in which all of the above conditions are met. While the strength of the polymer suture is maintained at a level of from 80% to 90%, micro teeth are formed on the surface of the suture preform, and burrs in the vicinity of the suture preform can be easily removed , so that the medical suture is properly manufactured.
    Figure 2 (a) is a view illustrating an image of an example of a suture preform; figure 2 (b) is a view illustrating images of front surfaces and cross sections of a suture preform; and figure 2 (c) is a view illustrating a deformation image of the polymer suture during heating and pressure formation.
    Then, in step (2), a tension force and a rotational force are applied to the suture preform in a vacuum state where the temperature condition from a point less than the melting point of matter press the suture to a point greater than the glass transition temperature is maintained, so that the maintained twisted suture is produced.
    In step (2), the tension force is applied to the suture preform, which is produced when heating and pressing in step (1), in the state where the two ends are anchored, and terminal treatment is performed for a predetermined time, so that the suture is manufactured as a secondarily formed product. At this time, the magnitude of the tension force is at a level of from 10% to 30% of the maximum tension resistance of the suture preform, more preferably, 20% of it. The heating time is in a range from 24 hours to 48 hours in a vacuum state.
    Additionally, in the step, when the tension force is applied, the rotational force is applied simultaneously, so that the twisting occurs in the medical suture. Therefore, the micro teeth are positioned along multiple helical directions. The magnitude of the rotational force is proportional to the length of the product primarily formed, and the angle of rotation of the two ends is in a range from 727cm (minimum) to 3607cm (maximum). The temperature during heating applied in the step is in a range from the glass transition temperature (Tg) to the melting point (Tm) of the raw material of the suture used to produce the suture preform, more preferably, in a range from a point of 30 ° C less than the melting point (Tm-30 ° C) to a point of 15 ° C less than the melting point (Tm-15 ° C).
    In the medical suture manufactured in accordance with the present invention, aciculae with directivity are formed as an ideal tooth shape. Once the teeth are formed by heating and pressing the spun suture thread, the teeth are positioned in a zigzag mode. Although the size of the micro teeth positioned on the surface of the medical suture is determined in proportion to the size of the suture thread, it is preferable that the size of the micro tooth is not greater than the diameter of the suture thread in terms of forming capacity. of product.
    The medical suture manufactured in accordance with the present invention has sufficient tissue anchoring capacity necessary for surgical administration and has the function of facilitating the regeneration of soft peripheral tissue. Additionally, as illustrated in figure 4 (a), the medical suture manufactured in accordance with the present invention has no physical knot since a cutting angle is not formed when cutting the surface of the suture thread. Therefore, in the medical suture according to the present invention, while the resistance of the suture of the same size is maintained to be at a level of from 80% to 90%, micro teeth can be formed on the surface as shown in the figure 4 (b).
    The medical suture according to the present invention is the medical suture where micro teeth are formed on the surface of the same by a method distinguished from the existing methods for the barbed suture or a tissue anchoring suture. The medical suture is a medical suture that can be effectively used to suture cut portions during a surgical operation and for plastics such as surgical lifting or administration of support for wrinkles on the face, neck, chest, and the like.
    Hereinafter, the present invention will be described in detail with reference to the modalities. However, the present invention is not limited to the modality. Comparative Example 1
    A polydioxanone suture produced from a single fiber and equipped with a USP1 size (diameter: 0.53 mm) was assembled and fixed to a general mold. Then, the suture was pressed and formed at room temperature at a pressure of 7 kgf / cm2 for 4 minutes. The thickness of a burr was 0.2 mm or more, and overflow space was not formed, so that a product was not separated from the burr. Therefore, a primarily formed product has not been formed. Comparative Example 2
    A polydioxanone suture produced from a single fiber and equipped with a USP1 size (diameter: 0.53 mm) was assembled and fixed to a general mold. Then, the suture was pressed and formed at a temperature of 125 ° C at a pressure of 7 kgf / cm2 for 4 minutes. A product was certainly separated from a burr, so that the burr was easily removed. Although the product was formed according to the formation space, due to heating at the melting point or more, thermal decomposition occurred and the molecular orientation was lost. Therefore, the tensile strength has been reduced to a level of 40%. Therefore, the product was not suitable for a primarily formed product. Comparative Example 3
    A polydioxanone suture produced from a single fiber and equipped with a USP2 size (diameter: 0.59mm) was mounted on an overflow mold. Then, the suture was pressed and formed at room temperature at a pressure of 140 kgf / cm2 for 5 seconds. The thickness of a burr was 50 pm or less. A product was certainly separated from the burr due to the overflow space, so that the burr can be removed. However, the suture was cracked in the cross section of the suture due to the phenomenon of compression and expansion. Therefore, the product was not suitable for a primarily formed product. First Mode
    A polydioxanone suture produced from a single fiber and equipped with a USP2 size (diameter: 0.59 mm) was mounted on an overflow mold. Then, the suture was pressed and formed at a temperature of 90 ° C at a pressure of 140 kgf / cm2 for 5 seconds. The thickness of a burr was 50 pm or less. A product was completely separated from the burr due to the overflow space without crack. A primarily formed product was heated in a vacuum state at a temperature of 90 ° C for 24 hours in the state where a tensile strength of 14N was applied to two ends of the same, so that the primarily formed product was transformed into a product secondarily formed. Regarding the size of a micro tooth formed in the product primarily formed, its height was in a range from 380 pm to 400 pm, its length was in a range from 1000 pm to 1100pm, the front angle it was in a range from 160 ° to 165 °, and the rear angle of it was in a range from 38 ° to 40 °. The phenomenon of compression and expansion did not occur before and after training, and the products formed were formed according to the training space. Therefore, the products formed were appropriate for the purpose of the present invention. Second Mode
    The polydioxanone suture produced from a single fiber and equipped with a USP2 size (diameter: 0.59 mm) was mounted on an overflow mold. Then, the suture was pressed and formed at a temperature of 90 ° C at a pressure of 140 kgf / cm2 for 5 seconds. The thickness of a burr was 50 pm or less. A product was completely separated from the burr due to the overflow space without crack. A primarily formed product was heated in a vacuum state at a temperature of 90 ° C for 24 hours, so that the primarily formed product was transformed into a secondary formed product. In this case, a force of 14N and a rotation of 72 ° / cm was applied to both ends of the same. The acicular teeth of the secondarily formed product were located in positions with rotation of 30 ° in both directions, so that a structure of multiple helical directions was formed. Therefore, the product formed was appropriate for the purpose of the present invention. Experimental Example
    The tensile strengths of the barbed sutures marketed by companies A, B, and C and the tensile strength of the spun thread of the suture manufactured according to the second embodiment of the present invention were compared by a method of measuring plastic elasticity. The result of the comparison is illustrated in figure 3.
    As illustrated in figure 3, the suture manufactured according to the second embodiment has a resistance of about 83% of the resistance of the spun thread of the suture. It can be understood that the resistance of the suture according to the second modality is much higher than the resistance of the commercialized barbed sutures.
    According to the present invention, it is possible to provide a medical suture with functions to allow micro teeth to protrude from the surface of the same to anchor soft tissue in the opposite direction to an insertion direction during insertion of the suture. soft tissue and generate physical stimulus according to the movement of the medical suture to facilitate tissue regeneration and able to adjust the size and shape of micro teeth to be used for medical administration such as plastic and wrinkle treatment.
    As previously described, the present invention is not limited to the above mentioned modalities and the accompanying drawings. It can be understood by those skilled in the related art that various substitutions, modifications, and changes can be produced within the scope of the present invention without departing from the spirit of the present invention.
    权利要求:
    Claims (8)
    [0001]
    1. Method of manufacturing a medical suture, CHARACTERIZED by the fact that it comprises: (1) producing the suture preform where micro teeth are formed on the surface of the suture when heating and pressing the raw material of the suture for surgery in a mold of overflow at a temperature condition from a point less than the melting point of the raw material of the suture to a point greater than the glass transition temperature at a pressure condition from 10 kgf / cm2 to 200 kgf / cm2 in a heat pressure solid phase formation method; and (2) producing the twisted suture maintained by heating the suture preform and applying a tensile and rotational force to a suture preform in a vacuum state where the temperature condition from a point less than the melting point of the raw material of the suture to a point greater than the glass transition temperature is maintained.
    [0002]
    2. Method, according to claim 1, CHARACTERIZED by the fact that the raw material of the suture is a medical polymer material with bioabsorbable property that is produced from any one selected from polydioxanone, poly- (1-lactic) acid, poly-glycolic acid, and copolymers thereof.
    [0003]
    3. Method, according to claim 1, CHARACTERIZED by the fact that the raw material of the suture is a medical polymer material endowed with a non-bioabsorbable property that is produced from any one selected from polypropylene, nylon, and mixtures thereof .
    [0004]
    4. Method, according to claim 1, CHARACTERIZED by the fact that the overflow mold is configured so that a space between the forming space and an overflow space is in a range from 30 pm to 60 pm, an introduction portion of the overflow space has an angle from 45 ° to 90 °, a depth of the overflow space is in a range from 50 pm to 100 pm, and a width of the overflow space is in a range range from 250 pm to 500 pm
    [0005]
    5. Method, according to claim 1, CHARACTERIZED by the fact that the tensile strength is at a level of from 10% to 30% of the tension resistance of the suture preform, and in which the rotational force corresponds to the rotation per unit length of the suture in a range from 72 ° / cm to 360 ° / cm.
    [0006]
    6. Method, according to claim 1, CHARACTERIZED by the fact that in step (2), a heating time is in a range from 24 hours to 48 hours.
    [0007]
    7. Method, according to claim 1, CHARACTERIZED by the fact that a suture size is in a range from 0.2 mm to 1 mm in diameter, and in which the height and width of the micro tooth are not larger than the suture diameter.
    [0008]
    8. Medical suture, manufactured according to the method defined in claim 1, CHARACTERIZED by the fact that micro teeth are formed on the surface of the suture, in which the rotation per unit length of the suture is applied in a band from 72 ° / cm to 360 ° / cm, and where the micro tooth has a directivity and has an anchoring capacity by which the soft tissue is anchored in a direction opposite to an insertion direction 10 when the suture is inserted into the soft tissue .
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    法律状态:
    2018-09-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-02-26| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2020-01-14| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2020-08-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-11-10| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/08/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    KR10-2011-0026122|2011-03-24|
    KR1020110026122A|KR101057377B1|2011-03-24|2011-03-24|Medical suture with micro cogs on the surface and producing method for the same|
    PCT/KR2011/006361|WO2012128432A1|2011-03-24|2011-08-29|Medical suture having micro cogs on a surface thereof, and method for manufacturing same|
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