Method for manufacturing surgical hemostatic clip and surgical hemostatic clip manufactured thereby

Abstract

Disclosed is a method for manufacturing a surgical hemostatic clip. The method for manufacturing a surgical hemostatic clip comprises: a 3D printing step of producing, through a 3D printing process, a surgical hemostatic clip including a pair of legs that are arranged to face each other so as to form an overall U-shape and have a polygonal cross-sectional shape, and a plurality of vascular pressing projections protruding from mutually facing inner surfaces of the pair of legs; a burr-removal step of removing burrs adhering to the edges or surfaces of the pair of legs and the plurality of vascular pressing projections; a heat-treatment step of heat-treating the deburred surgical hemostatic clip at a temperature of 500°C to 1000°C for 24 hours or more; and a surface-treatment step of heating the entire surface of the surgical hemostatic clip (100) to 450°C or higher by using an oxygen–propane flame to form a titanium oxide TiO2 layer, subsequently polishing the surface of the surgical hemostatic clip using at least one of Al2O3, V2O5, and SiO2 powders, and then polishing the surface of the surgical hemostatic clip using 50,000-mesh diamond powder.

Description

Method for manufacturing surgical hemostatic clips and surgical hemostatic clips manufactured thereby

[0001] The present invention relates to a method for manufacturing a surgical hemostatic clip and a surgical hemostatic clip manufactured thereby, and more particularly, to a method for manufacturing a surgical hemostatic clip and a surgical hemostatic clip manufactured thereby, which can facilitate the removal of a compressed surgical hemostatic clip when a hemostatic position is selected incorrectly.

[0002] In various surgical procedures, particularly those involving multiple organ resections, the need to cut veins or arteries or to control bleeding frequently occurs. To prevent excessive bleeding during blood vessel cutting, hemostasis is performed on both sides of the vessel to be severed before the procedure.

[0003] Typically, hemostasis of blood vessels is achieved by suturing or ligating them with surgical thread. However, this method requires manual suturing or ligating using needles and suture materials, making it time-consuming and difficult to perform in surgeries with limited space and visibility (especially endoscopic surgery). Furthermore, there is always the risk of vessel damage or thread dislodging or slipping during ligation. This risk is particularly high in larger vessels, and can lead to serious complications such as massive postoperative bleeding.

[0004] To address these problems associated with the use of surgical thread, surgical hemostatic clips have been proposed and widely used. Compared to surgical thread, these clips are relatively easy and quick to apply, and their use is increasing, not only in open surgery but also in endoscopic surgery.

[0005] Meanwhile, when using a surgical hemostatic clip, there may be cases where the surgical hemostatic clip needs to be removed due to incorrect selection of the hemostasis location, but there was a problem in that it was difficult to easily remove the surgical hemostatic clip from the hemostatic location.

[0006] Accordingly, the problem to be solved by the present invention is to provide a method for manufacturing a surgical hemostatic clip and a surgical hemostatic clip manufactured thereby, which improves surface quality, makes it easier to remove a compressed surgical hemostatic clip when a hemostatic location is selected incorrectly, and allows a plurality of blood vessel compression projections to be more easily detached from the hemostatic location.

[0007] A method for manufacturing a surgical hemostatic clip according to one embodiment of the present invention comprises: a 3D printing step of manufacturing a surgical hemostatic clip by a 3D printing process, the surgical hemostatic clip including a pair of legs facing each other so as to form a polygonal cross-sectional shape and an overall U-shape, and a plurality of vascular compression protrusions protruding on the inner surfaces of the pair of legs; a burr removal step of removing burrs from the edges or surfaces of the pair of legs and the plurality of vascular compression protrusions; a heat treatment step of heat-treating the surgical hemostatic clip from which the burrs have been removed at 500 to 1000 degrees for 24 hours or more; and heating the entire surface of the surgical hemostatic clip (100) to 450 degrees or more using an oxygen-propane flame to form a TiO2 titanium oxide layer, followed by Al2O 3, It is characterized by including a surface treatment step in which the surface of a surgical topographic clip is polished using at least one of V2O5 and SiO2 powders, and then the surface of the surgical topographic clip is polished using a diamond 50000 mesh.

[0008] In one embodiment, in the 3D printing step, a plurality of vascular compression projections are formed to include an inclined surface that slopes downward in a closed direction of a U-shaped arrangement structure of a pair of legs, a vertical surface formed vertically toward the inner surface of the legs from the upper end of the inclined surface, and an elastic deformation groove formed by being sunken in the center area of ​​the vertical surface, and the burr removal step may include a clip cooling step of introducing a surgical hemostatic clip into a barrel jaw and then injecting a coolant into the barrel jaw to cool the surgical hemostatic clip to a temperature of -150 degrees to -195 degrees; a burr separation step of introducing an abrasive into the barrel jaw and then rotating the barrel jaw to cause the surgical hemostatic clip and the abrasive to rub against each other for 10 minutes to 30 minutes to separate the burr of the surgical hemostatic clip; a burr discharge step of discharging the separated burr through a dust collector at the upper end of the barrel jaw; and a burr preheating step of returning the surgical hemostatic clip from which the burr has been removed to room temperature.

[0009] According to one embodiment of the present invention, a surgical hemostatic clip comprises a pair of legs having a polygonal cross-sectional shape and arranged to face each other so as to form a U-shape overall; and a plurality of vascular compression projections that are protruded on the inner surfaces of the pair of legs facing each other and are arranged to be interlocked with each other when the inner surfaces of the pair of legs are pressed against each other so as to be in close contact with each other, wherein each vascular compression projection comprises an inclined surface that slopes downward in the closed direction of the U-shaped arrangement structure of the pair of legs; a vertical surface formed vertically toward the inner surfaces of the legs from the upper ends of the inclined surfaces; and an elastic deformation groove formed to be sunken in the center region of the vertical surfaces.

[0010] According to the surgical hemostatic clip according to the present invention, the surface quality is improved, and when a hemostatic position is selected incorrectly, the surgical hemostatic clip can be easily removed, and when the surgical hemostatic clip is to be removed from the hemostatic position, when the surgical hemostatic clip is pulled in the direction of the inclined surface of the vascular compression protrusions, the vascular compression protrusions can be easily folded downward in the vertical direction, so that a plurality of vascular compression protrusions can be more easily detached from the hemostatic position.

[0011] Figure 1 is a flowchart showing the sequence of a method for manufacturing a surgical hemostatic clip according to one embodiment of the present invention.

[0012] Figure 2 is a flowchart showing the process sequence of the burr removal implementation step illustrated in Figure 1.

[0013] Fig. 3 is a drawing showing the configuration of a burr removal device used in the burr removal implementation step illustrated in Fig. 1.

[0014] FIG. 4 is a drawing showing the appearance of a surgical hemostatic clip according to one embodiment of the present invention.

[0015] Hereinafter, with reference to the attached drawings, a method for manufacturing a surgical hemostatic clip according to an embodiment of the present invention and a surgical hemostatic clip manufactured thereby will be described in detail. The present invention can be modified in various ways and can take various forms, and specific embodiments are illustrated in the drawings and described in detail in the text. However, this is not intended to limit the present invention to a specific disclosed form, but it should be understood that the present invention includes all modifications, equivalents, and substitutes included in the spirit and technical scope of the present invention. In describing each drawing, similar reference numerals are used for similar components. In the attached drawings, the dimensions of structures are illustrated larger than actual size to ensure clarity of the present invention.

[0016] While terms like "first" and "second" may be used to describe various components, these components should not be limited by these terms. These terms are used solely to distinguish one component from another. For example, without departing from the scope of the present invention, a first component could be referred to as a "second component," and similarly, a second component could also be referred to as a "first component."

[0017] The terminology used in this application is only used to describe specific embodiments and is not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly indicates otherwise. In this application, it should be understood that the terms "comprise" or "have" indicate the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0018] Unless otherwise defined, 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 this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0019] FIG. 1 is a flowchart showing the sequence of a method for manufacturing a surgical hemostatic clip according to one embodiment of the present invention, FIG. 2 is a flowchart showing the process sequence of a burr removal step shown in FIG. 1, FIG. 3 is a drawing showing the configuration of a burr removal device used in the burr removal step shown in FIG. 1, and FIG. 4 is a drawing showing the appearance of a surgical hemostatic clip according to one embodiment of the present invention.

[0020] Referring to FIGS. 1 and 4, a method for manufacturing a surgical hemostatic clip according to one embodiment of the present invention may include a 3D printing step (S100), a burr removal step (S200), a heat treatment step (S300), and a surface treatment step (S400).

[0021] In the 3D printing step (S100), the exterior of a surgical hemostatic clip (100) is formed. At this time, the surgical hemostatic clip (100) is formed to include a pair of legs (110) that are arranged to face each other so that the cross-sectional shape has a polygonal shape and forms an overall U-shape, and a plurality of blood vessel compression protrusions (120) that are protruded on the inner, facing surfaces of the pair of legs (110). At this time, the surgical hemostatic clip (100) is manufactured by 3D printing using a titanium material.

[0022] Additionally, a plurality of blood vessel compression projections (120) are formed to include an inclined surface (122) that slopes downward in the closed direction of the U-shaped arrangement structure of a pair of legs (110), a vertical surface (121) formed vertically toward the inner surface of the leg (110) from the upper end of the inclined surface (122), and an elastic deformation groove (123) formed by being sunken in the center area of ​​the vertical surface (121).

[0023] In the burr removal step (S200), burrs attached to the edges or surfaces of a pair of legs (110) and a plurality of blood vessel compression protrusions (120) are removed. Referring to FIG. 2, specifically, the burr removal step (S200) may include a clip cooling step (S210), a burr separation step (S220), a burr discharge step (S230), and a burr preheating step (S240).

[0024] The clip cooling step (S210) cools a plurality of surgical hemostatic clips (100) to a temperature of -150 degrees to -195 degrees by inserting a refrigerant into the barrel chamber (11) as shown in FIG. 3 and then injecting the refrigerant into the barrel chamber (11). At this time, if the temperature is lower than -150 degrees, it is difficult for the burr to easily fall off from the surgical hemostatic clip (100), and if it exceeds -195 degrees, there is a problem that a plurality of blood vessel compression protrusions (120) may fall off together with the burr.

[0025] The burr separation step (S220) involves injecting an abrasive (1) into a barrel chamber (11) and then rotating the barrel chamber (11) to cause friction between a plurality of surgical hemostatic clips (100) and the abrasive (1) for 10 to 30 minutes to separate the burrs of the surgical hemostatic clips (100). At this time, if the time is less than 10 minutes, the abrasive (1) may not have sufficient friction with the surgical hemostatic clips (100), making it difficult to remove the burrs. If the time exceeds 30 minutes, there is a problem that a portion of the surface of a plurality of blood vessel compression protrusions (120) may fall off due to the abrasive.

[0026] The burr discharge step (S230) discharges the separated burr through a dust collector (not shown) from the upper part of the barrel tank (11). At this time, the barrel tank (11) is maintained in a rotating state so that the separated burr moves to the upper part of the barrel tank (11) by the rotational force of the barrel tank (11) so that it can easily enter the inlet of the dust collector.

[0027] The burr preheating step (S240) returns a plurality of surgical hemostatic clips (100) from which burrs have been removed to room temperature. At this time, the rotation of the barrel tank (11) can be stopped, and the surgical hemostatic clips (100) from which burrs have been removed can be left inside the barrel tank (11) so that the plurality of surgical hemostatic clips (100) can be preheated to room temperature. For example, a first thermometer (not shown) for measuring room temperature and a second thermometer (not shown) for measuring the internal temperature of the barrel tank (11) can be provided in the burr removal device (10) including the barrel tank (11) so as to check whether the internal temperature of the barrel tank (11) has reached room temperature, and when the temperature of the barrel tank (11) has reached room temperature, it can be determined that the preheating of the plurality of surgical hemostatic clips (100) inside the barrel tank (11) is complete.

[0028] In the heat treatment step (S300), the surgical hemostatic clip (100) from which the burr has been removed is heat treated at 500 to 1000 degrees for 24 hours or more. Through this process, cracks can be prevented when a pair of legs (110) are compressed when the surgical hemostatic clip (100) is used. If the temperature is less than 500 degrees, it is difficult to reach the strength required to prevent cracks in the surgical hemostatic clip (100), and if it exceeds 1000 degrees, the surgical hemostatic clip (100) is excessively heat treated, which may cause cracks to occur during the heat treatment process.

[0029] In the surface treatment step (S400), the entire surface of the surgical hemostatic clip (100) is heated using an oxygen-propane flame to form a TiO2 titanium oxide layer, and then the surface of the surgical hemostatic clip (100) is heated to 450 degrees or more, and then Al2O 3, A process is performed in which the surface of a surgical topographic clip (100) is polished using at least one of V2O5 and SiO2 powders, and then the surface of the surgical topographic clip (100) is polished using a diamond 50000 mesh.

[0030] The process of forming a TiO2 titanium oxide layer is such that when the entire surface is locally heated for about 3 minutes using an oxygen-propane flame, a white TiO2 titanium oxide layer of about 20㎛ can be formed on the surfaces of a pair of legs (110) and a plurality of blood vessel compression protrusions (120). At this time, a scratch of about 100㎛ on the surface of the surgical hemostatic clip (100) can be completely removed due to volume expansion along with consumption of Ti due to the generation of TiO2. Therefore, the scratch on the surface can be absorbed and removed while first forming an oxide film, and in addition, there is an advantage in that the surface hardness can be lowered by heating the surface portion to 450 degrees or higher, thereby facilitating the subsequent polishing process.

[0031] Al2O 3, The process of polishing the surface of a surgical hemostatic clip (100) using at least one of V2O5 and SiO2 powders has the advantage of being able to quickly remove the oxide film on the surface as the surface hardness of the surgical hemostatic clip (100) is lowered during the previous process of forming a TiO2 titanium oxide layer. In addition, since most of the dust generated at this time is TiO2 dust, not Ti, it is already in an oxidized state and is therefore safe. In addition, since the amount of dust generated on the surface of the surgical hemostatic clip (100) is extremely small, there is almost no risk of explosion, so excellent safety can be secured during the polishing process.

[0032] The process of polishing the surface of a surgical hemostatic clip (100) using a 50000 mesh diamond may take 10 minutes, and if polished for 10 minutes using a 50000 mesh diamond, a surface roughness of about 0.04㎛ can be obtained, and accordingly, the surface roughness of the surgical hemostatic clip (100) can be minimized, thereby improving the surface quality of the surgical hemostatic clip (100).

[0033] The surgical hemostatic clip shown in Fig. 3 can be manufactured using this method for manufacturing a surgical hemostatic clip.

[0034] Referring to FIG. 4, a surgical hemostatic clip according to one embodiment of the present invention may include a pair of legs (110) that have a polygonal cross-sectional shape and are arranged to face each other so as to form an overall U-shape; and a plurality of blood vessel compression projections (120) that are formed to protrude on the inner surfaces facing each other of the pair of legs (110) and are arranged to be interlocked with each other when the inner surfaces of the pair of legs (110) are compressed so as to be in close contact with each other.

[0035] Meanwhile, each blood vessel compression projection (120) may include an inclined surface (122) that slopes downward in the closed direction of the U-shaped arrangement structure of a pair of legs (110); a vertical surface (121) formed vertically toward the inner surface of the leg (110) from the upper end of the inclined surface (122); and an elastic deformation groove (123) formed by being sunken in the center area of ​​the vertical surface (121).

[0036] These multiple vascular compression protrusions (120) interlock with each other in a form where the vascular compression protrusions (120) are alternately positioned when a pair of legs (110) are compressed to stop bleeding in a blood vessel, for example. At this time, if the position of the hemostasis, for example, the topographical position of the blood vessel, is to be changed after the pair of legs (110) are compressed, the vascular compression protrusions (120) can be easily detached from the blood vessel by pulling the pair of legs (110) in the direction of the slanted surface (122). Therefore, there is an advantage in that the surgical hemostatic clip (100) can be easily removed in case of an error in the selection of the hemostasis position.

[0037] In addition, when the surgical hemostatic clip (100) is to be removed from the hemostatic position, the elastic deformation groove (123) has the advantage that the vascular compression projections (120) can be easily folded downward in the vertical plane (121) when the surgical hemostatic clip (100) is pulled in the direction of the inclined surface (122) of the vascular compression projections (120), and by this action, a plurality of vascular compression projections (120) can be more easily detached from the hemostatic position.

[0038] According to the surgical hemostatic clip according to one embodiment of the present invention, the surface quality is improved, and when the hemostatic position is selected incorrectly, the removal of the compressed surgical hemostatic clip (100) can be made easier, and when the surgical hemostatic clip (100) is to be removed from the hemostatic position, when the surgical hemostatic clip (100) is pulled in the direction of the inclined surface (122) of the vascular compression protrusions (120), the vascular compression protrusions (120) can be easily folded downward in the direction of the vertical surface (121), so that a plurality of vascular compression protrusions (120) can be more easily detached from the hemostatic position.

[0039] Meanwhile, a method for manufacturing a surgical hemostatic clip according to another embodiment of the present invention may further include a step of applying an anti-contamination coating layer (not shown).

[0040] The step of applying the anti-pollution coating layer can be performed after the surface treatment step.

[0041] In the step of applying the anti-contamination coating layer, a contamination-resistant coating layer composed of a composition for anti-contamination coating can be applied to the surface of the surgical hemostatic clip (100) to improve the contamination resistance.

[0042] The above-mentioned anti-fouling coating composition contains acyl lactylate and lauryl amidopropyl betaine in a molar ratio of 1:0.01 to 1:2, and the total content of acyl lactylate and lauryl amidopropyl betaine is 1 to 12 wt% based on the total aqueous solution.

[0043] The molar ratio of the above acyl lactylate and lauryl amidopropyl betaine is preferably 1:0.01 to 1:2. If the molar ratio is outside the above range, there is a problem that the applicability on the surgical hemostatic clip (100) is reduced or the moisture adsorption on the surface increases after application, resulting in the removal of the application film.

[0044] The above acyl lactylate and lauryl amidopropyl betaine are preferably present in an amount of 1 to 12 wt% of the total aqueous composition. If the amount is less than 1 wt%, there is a problem that the applicability on the surgical hemostatic clip (100) is reduced, and if the amount exceeds 12 wt%, crystal precipitation is likely to occur due to an increase in the thickness of the coating film.

[0045] Meanwhile, the method for applying the composition for coating the present invention on a surgical hemostatic clip (100) is preferably by spraying. In addition, the final coating film thickness on the surgical hemostatic clip (100) is preferably 700 to 2000 Å. If the thickness of the coating film is less than 700 Å, there is a problem of deterioration in the case of high-temperature heat treatment, and if it exceeds 2000 Å, there is a disadvantage of easy occurrence of crystal precipitation on the coating surface.

[0046] In addition, the present composition for anti-fouling coating can be prepared by adding 0.1 mol of acyl lactylate and 0.05 mol of lauryl amidopropyl betaine to 1000 ml of distilled water and then stirring.

[0047] The reason why the ratio of the above components and the thickness of the coating film are numerically limited as above is that the inventor of the present invention analyzed the test results through repeated failures and showed the optimal anti-pollution coating effect at the above ratio.

[0048] The description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the scope of the present invention. Therefore, the present invention is not intended to be limited to the embodiments disclosed herein, but is to be construed in the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A 3D printing step (S100) of manufacturing a surgical hemostatic clip (100) using a 3D printing process, the surgical hemostatic clip including a pair of legs (110) facing each other so as to form a U-shape overall and having a polygonal cross-sectional shape, and a plurality of blood vessel compression protrusions (120) protruding on the inner facing surfaces of the pair of legs (110); A burr removal step (S200) for removing burrs attached to the edges or surfaces of a pair of legs (110) and a plurality of blood vessel compression protrusions (120); A heat treatment step (S300) of heat-treating a surgical hemostatic clip (100) from which the burr has been removed at 500 to 1000 degrees for 24 hours or more; and The entire surface of a surgical hemostatic clip (100) is heated to 450 degrees or more using an oxygen-propane flame to form a TiO2 titanium oxide layer, followed by Al2O 3, A surface treatment step (S400) is included, in which the surface of a surgical topographic clip (100) is polished using at least one of V2O5 and SiO2 powders, and then the surface of the surgical topographic clip (100) is polished using a diamond 50000 mesh. Method for manufacturing surgical hemostatic clips.

2. In paragraph 1, In the 3D printing step (S100), a plurality of blood vessel compression projections (120) are formed to include an inclined surface (122) slanting downward in the closed direction of the U-shaped arrangement structure of a pair of legs (110), a vertical surface (121) formed vertically toward the inner surface of the leg (110) from the top of the inclined surface (122), and an elastic deformation groove (123) formed by being sunken in the center area of ​​the vertical surface (121). The burr removal implementation step (S200) is A clip cooling step (S210) in which a surgical hemostatic clip (100) is inserted into the barrel chamber (11) and then a refrigerant is injected into the barrel chamber (11) to cool the surgical hemostatic clip (100) to a temperature of -150 degrees to -195 degrees; A burr separation step (S220) in which the burr of the surgical hemostatic clip (100) is separated by rubbing the surgical hemostatic clip (100) and the abrasive (1) against each other for 10 to 30 minutes while rotating the barrel (11) after injecting the abrasive (1) into the barrel (11); A burr discharge step (S230) for discharging burrs separated from the upper part of the barrel (11) through a dust collector; and Including a burr preheating step (S240) for returning the surgical hemostatic clip (100) from which the burr has been removed to room temperature. Method for manufacturing surgical hemostatic clips.

3. A pair of legs (110) arranged facing each other so that the cross-sectional shape has a polygonal shape and forms an overall U shape; and It includes a plurality of blood vessel compression protrusions (120) that are protruded on the inner surfaces facing each other of a pair of legs (110) and arranged so that they can be interlocked with each other when the inner surfaces of a pair of legs (110) are pressed so that they are in close contact with each other. Each vascular compression projection (120) is A U-shaped arrangement structure of a pair of legs (110), a slope (122) sloping downward in the closed direction of the U; A vertical surface (121) formed vertically toward the inner surface of the leg (110) at the top of the slope (122); and Including an elastic deformation groove (123) formed by being sunken in the center area of ​​the vertical surface (121). Surgical hemostatic clips.

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