Medical suture

Abstract

One embodiment of the present invention provides a medical suture comprising: a core filament extending in one direction; a plurality of micro-protrusions protruding from the outer surface of the core filament; and a mesh in contact with the core filament while surrounding same.

Description

Medical sutures

[0001] The present invention relates to a medical suture.

[0002] Sutures are used not only to connect or close various damaged areas of animal tissue and surgical incisions, but also for cosmetic purposes such as tissue lifting procedures like facial lifts.

[0003] Conventional sutures are broadly classified into absorbable sutures made of materials that decompose within the body and non-absorbable sutures made of materials that do not decompose, and are used appropriately depending on the purpose, site of use, and application. However, conventional sutures, which are smooth cylindrical in shape, have weak fixation to tissues, a very high Young's modulus, and low elongation, so if they are not fixed, they can easily be exposed to the outside or detach from the surgical site.

[0004] To improve this, manufacturing methods have begun to emerge that process the shape of existing sutures into various forms. For example, there are forms such as barbed sutures created by cutting the suture to form barbs, sutures with improved fixation strength created by processing the raw material into an intaglio using ultrasound, sutures formed into barbs by flattening a cylindrical suture with a press and then cutting it with equipment such as a puncher to facilitate processing, and sutures formed into barbs by molding with an extrusion mold.

[0005] Recently, formulations such as Fig. 1, in which a mesh is wrapped around a core thread for additional functionality, have emerged. This formulation is manufactured by attaching a mesh made of mandrel to a core thread, but a problem occurred where the protrusions formed on the core thread bent during the process of attaching the mesh to the core thread. In addition, the above formulation had a problem in that a gap occurred between the mesh and the core thread, weakening the fixation force with the tissue, and the volume increased, making it difficult to insert into a cannula.

[0006] The present invention aims to solve the problems of the aforementioned prior art, and the objective of the present invention is to provide a medical suture that effectively reduces overall volume and improves fixation strength.

[0007] One aspect of the present invention provides a medical suture comprising: a central thread extending in one direction; a plurality of micro-protrusions formed protruding from the outer surface of the central thread; and a mesh formed to surround the central thread and abut the central thread.

[0008] In one embodiment, the micro-protrusions may protrude outside the mesh.

[0009] In one embodiment, the mesh may be composed of a plurality of alternating micro-chambers.

[0010] In one embodiment, the mesh may be composed of 4 or more and 16 or fewer micro-chambers.

[0011] In one embodiment, the diameter of the micro-thread may be 0.05 mm or more and 0.199 mm or less.

[0012] In one embodiment, the micro-protrusion may protrude in a direction inclined to the one direction.

[0013] In one embodiment, the micro-protrusion includes a first inclined portion arranged at a first inclined angle with respect to the center chamber and a second inclined portion connected to the first inclined portion and arranged at a second inclined angle with respect to the center chamber, wherein the second inclined angle may be larger than the first inclined angle.

[0014] In one embodiment, the second inclination angle may be formed to be 20 degrees or more and 90 degrees or less.

[0015] In one embodiment, the height of the micro-protrusion may be 0.1 mm or more and 0.6 mm or less.

[0016] In one embodiment, the unidirectional length of the micro-protrusion may be 0.5 mm or more and 5 mm or less.

[0017] In one embodiment, the micro-protrusions aligned in a row along the outer surface of the central chamber may be arranged at equal intervals from each other.

[0018] In one embodiment, the medical suture may be made of a bioabsorbable medical polymer material selected from polydioxanone, polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxyalkanoates, and copolymers thereof.

[0019] In one embodiment, the medical suture may be made of a bio-nonabsorbable medical polymer material selected from polypropylene, nylon, and mixtures thereof.

[0020] A medical suture according to one aspect of the present invention is formed such that a mesh surrounds a central thread and abuts against the central thread, thereby reducing the overall volume and significantly improving tensile strength and fixation strength compared to conventional medical sutures.

[0021] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the configuration of the invention described in the detailed description or claims of the present invention.

[0022] Figure 1 is a conventional medical suture.

[0023] FIG. 2 is a medical suture according to one embodiment of the present invention.

[0024] FIG. 3 is a schematic diagram of a central chamber and a micro-protrusion according to one embodiment of the present invention.

[0025] Figure 4 is a graph showing the results of comparing the tensile strength of a medical suture according to one embodiment of the present invention and a medical suture of Comparative Example 1.

[0026] Figure 5 is a graph showing the results of comparing the fixation strength of a medical suture according to one embodiment of the present invention and a medical suture of Comparative Example 1.

[0027] FIG. 6 is a graph showing the results of comparing the fixation strength of a medical suture according to one embodiment of the present invention and a medical suture of Comparative Example 2.

[0028] The present invention will be described below with reference to the attached drawings. However, the present invention may be implemented in various different forms and is therefore not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification have been given similar reference numerals.

[0029] Throughout the specification, when it is stated that a part is "connected" to another part, this includes not only cases where they are "directly connected," but also cases where they are "indirectly connected" with other members interposed between them. Furthermore, when it is stated that a part "includes" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but rather allows for the inclusion of additional components.

[0030] Terms including ordinal numbers such as ‘first’ or ‘second’ used herein may be used to describe various components or steps, but such components or steps should not be limited by ordinal numbers. Terms including ordinal numbers should be interpreted solely for the purpose of distinguishing one component or step from other components or steps.

[0031] The medical suture of the present invention is used not only to connect or suture various damaged areas of animal tissues such as skin, muscles, tendons, internal organs, bone tissue, nerves, and blood vessels, as well as incision sites resulting from surgical procedures, but can also be used for cosmetic purposes such as tissue lifting procedures like facial lifting.

[0032] The medical suture of the present invention can be manufactured from a single-strand polymer. Specifically, for example, the medical suture can be manufactured from a bioabsorbable medical polymer composed of one or more of polydioxanone, monocryl, polycaprolactone, polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), poly(lactide-co-caprolactone), and polyhydroxyalkanoates.

[0033] In addition, the medical suture of the present invention may be manufactured from a non-absorbable medical polymer composed of one or more of polypropylene, nylon, and polytetrafluoroethylene.

[0034] The medical suture of the present invention is not limited to a specific material, and it goes without saying that all polymers can be applied.

[0035] FIG. 2 is a medical suture according to one embodiment of the present invention.

[0036] A medical suture (1) according to one embodiment of the present invention includes a central thread (10) extending in one direction, a micro-protrusion (20), and a mesh (30).

[0037] The center chamber (10) can be formed into a linear structure including elasticity, and the micro-protrusions (20) can be formed on the outer surface of the center chamber (10).

[0038] The micro-protrusion (20) is a protrusion shape formed around the central thread (10) and can be formed in a direction inclined to the direction in which the central thread (10) extends. The micro-protrusion (20) can be implemented as a barb or the like, but is not necessarily limited thereto. Here, a barb refers to a hook shape resembling a barb, such as a fishing hook.

[0039] The mesh (30) is composed of a plurality of alternating micro-threads (31). As the plurality of micro-threads (31) are arranged to intersect each other, a grid-shaped space (32) is formed between the micro-threads (31), and the micro-protrusions (20) protrude to the outside of the mesh (30) through the space (32).

[0040] The mesh (30) is formed to surround the center thread (10) and to be in contact with the center thread (10). In detail, a portion of the micro-thread (31) is positioned in contact with the center thread (10). More specifically, the mesh (30) extends along the longitudinal axis of the center thread (10), and the entire area of ​​the mesh (30) is formed to be in substantial contact with the center thread (10).

[0041] Accordingly, the maximum radius from the axis of the center thread (10) to the mesh (30) can be formed to be smaller than the maximum radius from the axis of the center thread (10) to the micro-protrusion (20). Here, the radius refers to the radial length with respect to the axis of the center thread (10).

[0042] In one embodiment, the mesh (30) may be composed of 4 or more and 16 or fewer fine threads (31).

[0043] In one embodiment, the diameter of the micro-thread (31) may be formed to be 0.05 mm or more and 0.199 mm or less.

[0044]

[0045] FIG. 3 is a schematic diagram of a central chamber and a micro-protrusion according to one embodiment of the present invention.

[0046] The micro-protrusion (20) is formed on the outer surface of the center chamber (10) and includes a first inclined portion (21) arranged at a first inclined angle (A1) with the center chamber (10), and a second inclined portion (22) connected to the first inclined portion (21) and arranged at a second inclined angle (A2) with the center chamber (10).

[0047] The second angle of inclination (A2) is larger than the first angle of inclination (A1), and this serves to increase the fixation force when the suture is inserted into the tissue. For example, the second angle of inclination (A2) can be formed to be between 20 degrees and 90 degrees.

[0048] The height (h) of the micro-protrusion (20) is 0.1 mm or more and 0.6 mm or less, and the horizontal length (d1) is formed to be 0.5 mm or more and 5 mm or less.

[0049] Additionally, the micro-protrusions (20) are spaced at equal intervals to provide consistent fixation force for the suture. For example, micro-protrusions (C1, C3 …) located on one side of the central thread (10) can be spaced at equal intervals (d2) from each other. Additionally, micro-protrusions (C2, C4 …) located on the other side of the central thread (10) can be spaced at equal intervals (d2) from each other.

[0050] That is, the micro-protrusions (20) arranged in a line along the outer surface of the central chamber (10) can be arranged at equal intervals from each other. However, this is not limited thereto, and all micro-protrusions (C1, C2, C3, C4 …) can be arranged at equal intervals from each other.

[0051] In addition, the micro-protrusions of the medical suture of the present invention are formed in a raised shape. Specifically, the medical suture of the present invention is manufactured by applying a central thread extending in one direction to an outflow mold and forming micro-protrusions on the outer surface of the central thread within a range higher than the glass transition temperature (Tg) and lower than the melting point (Tm). Accordingly, since stress distribution is easily achieved through the raised micro-protrusions formed on the central thread, the micro-protrusions do not easily bend even when a load is applied to them during the mesh formation process.

[0052] In contrast, conventional medical sutures that form micro-protrusions by cutting a portion of the central thread have stress concentrated at the connection points of the micro-protrusions, causing the protrusions to easily bend.

[0053] Due to these structural differences, the medical suture of the present invention provides higher durability and stability compared to the prior art.

[0054]

[0055] The embodiments of this specification will be described in more detail below. However, the following experimental results represent only representative results among the above embodiments, and the scope and content of this specification should not be interpreted as being narrowed or limited by the embodiments. The respective effects of various embodiments of this specification not explicitly presented below will be described in detail in the relevant sections.

[0056]

[0057] Example 1

[0058] A central thread formed of polydioxanone material and extending in one direction was applied to an outflow mold with protrusions, and micro-protrusions were formed on the outer surface of the central thread in a range higher than the glass transition temperature (Tg) and lower than the melting point (Tm). In addition, a medical suture according to the example was manufactured by wrapping the central thread while applying a predetermined tensile force to each of the eight micro-threads so that the mesh adheres to the central thread.

[0059]

[0060]

[0061] Comparative Example 1

[0062] A medical suture was manufactured by forming micro-protrusions on the central thread in the same manner as in Example 1, and the mesh manufacturing step was omitted.

[0063]

[0064] Comparative Example 2

[0065] Micro-protrusions were formed on the central thread in the same manner as in Example 1, and a mesh made of 8 strands of micro-threads by mandrel was combined with the central thread to manufacture a medical suture.

[0066]

[0067] Experimental Example 1: Measurement of Tensile Strength of Medical Sutures

[0068] Tensile strength is USP 43-NF38 of the U.S. Food and Drug Administration <881> Tensile Strength was measured. Specifically, the medical sutures of the comparative example and the example were fixed to the top and bottom of the clamp. The gauge distance between the clamps was set to 40 mm, and the driving speed of the clamp was set to 80 mm / min. Tensile strength was measured at the point where the medical suture broke, and the results are shown in Fig. 4.

[0069] Referring to Fig. 4, it was confirmed that the tensile strength of the medical suture of Example 1 was improved by approximately 30% compared to the medical suture of Comparative Example 1, which was not equipped with a mesh.

[0070]

[0071] Experimental Example 2: Measurement of fixation strength of medical sutures

[0072] Fixation strength was measured using the fixation strength test medium specified in the Korean Ministry of Food and Drug Safety’s Guidelines for Performance Evaluation of Facial Tissue Fixation Threads (MFDS).

[0073] Specifically, the fixation test medium consists of a three-layer structure comprising an upper layer silicone, a middle layer composed of gauze, and a lower layer silicone. A medical suture of the comparative example or the example was inserted parallel to the middle layer (gauze) of the fixation test medium by about 10 cm, and the fixation test medium inserted between the medical sutures and the end of the medical suture were each fixed to the top and bottom of the clamp. Subsequently, the clamp was driven at a predetermined speed to pull the medical suture and extract it from the fixation test medium, and the force for displacement of the medical suture was measured, and the results are as shown in FIGS. 5 and 6.

[0074] Referring to Fig. 5, it was confirmed that the fixation strength of the medical suture of Example 1 was improved by approximately 20% compared to the medical suture of Comparative Example 1.

[0075] Referring to Fig. 6, it was confirmed that the fixation strength of the medical suture of Example 1 was improved by approximately 15% compared to the medical suture of Comparative Example 2. This is because the mesh of Example 1 adheres closely to the central thread, thereby minimizing the displacement occurring within the tissue when the suture is pulled after being inserted into the tissue.

[0076] In addition, in Comparative Example 2, the mesh and the central thread were separated, resulting in a large volume of mesh. Consequently, only cannulas with a large diameter could be used during suture implantation, which led to limited use depending on the surgical site and the patient's condition.

[0077] On the other hand, in Example 1, the mesh adhered to the central thread, reducing the maximum diameter of the medical suture, and accordingly, suture implantation was possible by combining it with a small diameter cannula.

[0078] In conclusion, the medical suture according to one embodiment of the present invention has a mesh that adheres closely to the central thread, thereby reducing the overall volume, and furthermore, the tensile strength and fixation force are significantly improved compared to conventional medical sutures.

[0079] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical spirit or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single unit may be implemented in a distributed manner, and components described as distributed may likewise be implemented in a combined form.

[0080] The scope of the present invention is defined by the claims set forth below, and all modifications or variations derived from the meaning and scope of the claims and equivalent concepts thereof should be interpreted as being included within the scope of the present invention.

[0081]

[0082] [Explanation of the symbol]

[0083] 1 medical suture

[0084] 10 Central Room

[0085] 20 micro-protrusions

[0086] 30 mesh

Claims

1. A central thread extending in one direction; A plurality of micro-protrusions formed protruding from the outer surface of the above central chamber; and A medical suture comprising a mesh formed to surround the central thread and abut the central thread.

2. In Paragraph 1, A medical suture characterized in that the above-mentioned micro-protrusions protrude outside the mesh.

3. In Paragraph 1, A medical suture characterized in that the above mesh is composed of a plurality of alternating micro-threads.

4. In Paragraph 3, A medical suture characterized in that the above mesh is composed of 4 or more and 16 or fewer fine threads.

5. In Paragraph 3, A medical suture characterized in that the diameter of the micro-thread is 0.05 mm or more and 0.199 mm or less.

6. In Paragraph 1, A medical suture characterized in that the micro-protrusions protrude in a direction inclined to the above-mentioned one direction.

7. In Paragraph 1, The above micro-protrusions are, The above central chamber and the first inclined section arranged at the first inclined angle and It includes a second inclined section connected to the first inclined section and arranged at a second inclined angle with the center chamber, and A medical suture characterized in that the second angle of inclination is larger than the first angle of inclination.

8. In Paragraph 7, A medical suture characterized in that the second inclination angle is formed to be between 20 degrees and 90 degrees.

9. In Paragraph 1, A medical suture characterized in that the height of the micro-protrusions is 0.1 mm or more and 0.6 mm or less.

10. In Paragraph 1, A medical suture characterized in that the unidirectional length of the microprotrusions is 0.5 mm or more and 5 mm or less.

11. In Paragraph 1, A medical suture characterized by micro-protrusions arranged in a row along the outer surface of a central thread and spaced at equal intervals from each other.

12. In Paragraph 1, The above medical suture is, A medical suture characterized by being composed of a bioabsorbable medical polymer material selected from polydioxanone, polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxyalkanoates, and copolymers thereof.

13. In Paragraph 1, The above medical suture is, A medical suture characterized by being made of a bio-nonabsorbable medical polymer material selected from polypropylene, nylon, and mixtures thereof.

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