KR20200020355A - Needle assembly and manufacturing method thereof - Google Patents

Abstract

According to one embodiment of the present invention, a needle assembly capable of suppressing infection of a subject and worker comprises: a hollow needle; a hub disposed to penetrate the needle; a holder coupled with the hub and accommodating part of the needle; and a sleeve accommodated in the holder and mounted on the needle to surround a portion of the needle accommodated in the holder. The hub may include a breaking unit formed on a side portion, broken by external impact, and dividing the hub.

Description

Needle assembly and manufacturing method

Embodiments relate to a needle assembly used for blood collection and a method of manufacturing the same.

The content described in this section merely provides background information on the embodiments and does not constitute a prior art.

Interest in health continues to grow, and technology for clinical diagnostics continues to develop. In general, a large amount of blood is collected in clinical diagnostic tests.

Since blood may be contaminated or blood infection may occur in the blood collection process, it is necessary for the blood sample to be easily and quickly performed by the test subjects and workers.

In the blood collection process, a blood collection tube having a negative pressure or a constant vacuum level, that is, a vacuum collection tube may be used, and a needle assembly, which is a collection apparatus including a needle, may be used to collect blood in the vacuum collection tube.

In the case of the needle assembly, a metal needle and a holder of a non-metal material to which the needle is fixed and coupled to a blood collection tube may be coupled to each other. On the other hand, in order to prevent contamination or infection, the used needle assembly needs to dispose of the needle with the blood of the subject separated from other components.

Use and disposal of such needle assemblies need to be proceeded safely, easily and quickly to suppress infection of the subject and operator.

Accordingly, the embodiment relates to a needle assembly having a structure that can be safely and easily used and disposed of quickly and safely so as to suppress infection of a subject and an operator, and a method of manufacturing the same.

Embodiments of the present invention are not limited to the above-mentioned technical problems, and other technical problems not mentioned above may be clearly understood by those skilled in the art to which the embodiments belong.

One embodiment of the needle assembly includes a hollow needle; A hub disposed to penetrate the needle; A holder coupled to the hub, the holder receiving a portion of the needle; And a sleeve received in the holder and mounted to the needle to surround a portion received in the holder of the needle, wherein the hub includes a break formed at the side and broken by an external impact to divide the hub. It may be.

The hub and the holder are integrally formed, and the needle may be fixed to the hub by an adhesive.

The adhesive may be a heat curable or ultraviolet curable epoxy.

The sleeve may be formed of an elastic material, formed in a tubular shape so as to fit into a part of the needle, and in a state of being mounted on the needle, the end may be spaced apart from one end of the needle.

The hub protrudes into the holder, an inner circumferential surface surrounds a portion of the needle, and an outer circumferential surface includes an undercut on which the sleeve is mounted, the undercut is formed with an inclined surface and the other side with a stepped surface, A stopper to which the end of the sleeve is fitted may be formed.

The needle may be a silicon coating layer is formed on a portion that is inserted into the blood vessel of the subject.

The break portion may be formed in the circumferential direction on the side portion, and include a first groove having a V-shaped cross section.

The break portion may be formed in a plurality in the circumferential direction in a plurality at the side portion, the second groove having a cross-section is U-shaped.

The break portion may be formed in a plurality in the circumferential direction in a plurality at the side portion, and may include a first through-hole formed through the side portion.

One embodiment of the needle assembly manufacturing method, the hub supply step of supplying a hub; A needle supplying step of supplying a needle; A needle insertion step of inserting the needle into the hub; Bonding the needle to the hub with an adhesive; A silicon coating step of forming a silicon coating layer on a portion exposed to the outside of the needle; An inspection step of inspecting adhesion and defects of the silicon coating layer; And a sleeve mounting step of mounting a sleeve on a portion of the needle, wherein the hub may include a break formed at a side and broken by an external impact to divide the hub.

The needle supplying step may include a needle sorting step in which a needle sorting device sequentially sorts a plurality of the needles; A needle suction step of a needle insertion device for sucking the needles aligned using vacuum means; And a needle disposition step of disposing the needle at a position corresponding to the needle insertion portion of the hub.

One embodiment of the needle assembly manufacturing method, after the sleeve mounting step, the cap coupling step of coupling the cap to the needle; A labeling step of labeling the needle assembly; And a sterilization step of sterilizing the needle assembly.

In the needle assembly of the embodiment, the needle is fixedly coupled to the holder, so that the process of coupling the needle to the holder by the operator is omitted in comparison with the related art. Due to this structure, it is possible to reduce the blood collection time and the operator's effort, and also to prevent the operator from being stuck by the needle in the process of coupling the needle to the holder.

In an embodiment, by applying an external shock to the needle assembly to be discarded, the needle can be easily separated from the holder, and the process of separating the needle and the holder manually screwed from each other can be omitted. Due to this structure, it is possible to reduce the blood collection time and the operator's effort, and also to prevent the operator from being stuck by the needle in the process of separating the needle and the holder from each other.

1 is a view for explaining a needle assembly of an embodiment.
2 is a cross-sectional view of the needle assembly of one embodiment.
3 is a cross-sectional view illustrating a fracture portion of an embodiment.
4 is a cross-sectional view for explaining a fracture portion of another embodiment.
5 is a cross-sectional view for explaining a fracture portion of still another embodiment.
6 is a flowchart illustrating a method of manufacturing a needle assembly according to one embodiment.
7 is a flow chart for explaining the needle supply step in the needle assembly manufacturing method of an embodiment.
8 is a view for explaining a process after the sleeve mounting step in the needle assembly manufacturing method of an embodiment.

Hereinafter, exemplary embodiments will be described in detail with reference to the accompanying drawings. The embodiments may be variously modified and may have 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 embodiments to the specific forms disclosed, it should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the embodiments.

Terms such as "first" and "second" may be used to describe various components, but the components should not be limited by the terms. The terms are used to distinguish one component from another. In addition, terms that are specifically defined in consideration of the configuration and operation of the embodiments are only intended to describe the embodiments and do not limit the scope of the embodiments.

In the description of the embodiments, when described as being formed at "on" or "on" or "under" of each element, it is on or under. ) Includes both elements that are in direct contact with each other or one or more other elements are formed indirectly between the two elements. In addition, when expressed as "up" or "on (under)", it may include the meaning of the downward direction as well as the upward direction based on one element.

Furthermore, the relational terms used below, such as "upper / upper / up" and "lower / lower / lower", etc., do not necessarily require or imply any physical or logical relationship or order between such entities or elements, It may be used to distinguish one entity or element from another entity or element.

1 is a view for explaining a needle assembly of an embodiment. 2 is a cross-sectional view of the needle assembly of one embodiment. The needle assembly is used to collect blood of a subject, and one end of the needle 100 is inserted into a blood vessel of the subject, and the other end is inserted into the blood vessel 10.

For clarity below, referring to FIGS. 1 and 2, a portion of the needle 100 protruding upward from the hub 200 from the hub 200 is referred to as a needle top portion, and the holder of the needle 100 is referred to as a needle top portion. 2, a portion projecting downward from the hub 200 in the downward direction of the paper is referred to as a needle lower portion.

That is, first the upper needle is inserted into the blood vessel of the subject, and then the lower needle is inserted into the blood collection tube 10, the blood of the subject may be introduced into the blood collection tube 10 through the upper needle and the lower needle from the blood vessel.

At this time, since the blood collection tube 10 maintains a negative pressure or a degree of vacuum, when the lower part of the needle is inserted into the blood collection tube 10, blood of the subject may be introduced into the collection tube 10 due to the pressure difference.

In the blood collection process, the vacuum of the blood collection tube 10 and the amount of blood collected are matched. In the manufacturing process, the vacuum degree inside the blood collection tube 10 can be adjusted, and the vacuum degree can be set to about 1 to 8 ml, and the set vacuum is maintained. It is closed with a rubber stopper. The blood collection tube 10 may be provided with a glass or PET material except for a rubber stopper, that is, a tube in which blood is accommodated.

The size of the tube of the collection tube 10 is in accordance with the specifications of the American Society of Clinical Pathology (NCCLs), and may be mainly ø13 x 75mm, ø13 x 100mm, ø16 x 75mm, ø16 x 100mm, and the like.

The needle assembly of an embodiment may include a needle 100, a hub 200, a holder 300 and a sleeve 400.

Needle 100 may be provided in a hollow. 1 to 5, a single needle is illustrated, but the needle 100 may be provided as a multi needle having a plurality of needles in one hub 200. In this case, the multi-needles may include a double needle, a double-pointed needle, and a multi sample needle. In the following description, only the needle of the single needle structure is illustrated and described for clarity.

Needle 100 of the embodiment is used for blood collection, the size is mainly 21 gauge (gauge) is used, it is appropriate to use a needle of 16 to 23 gauge. The material of the needle 100 is made of stainless steel (SUS304).

The upper needle is a portion to be inserted into the blood vessel, the lower needle is a portion to be inserted into the blood collection tube (10). Therefore, bevels (bevels) are formed at both ends of the needle 100 to facilitate insertion. In particular, the bevel of the distal end of the needle to be inserted into the blood vessel is formed in a double, the needle 100 can be easily inserted into the blood vessel.

Referring to FIG. 2, the needle 100 may have a silicon coating layer 500 formed on a portion of the needle, ie, on the needle. The silicon coating layer 500 may be formed on an outer surface of the needle 100. The silicon coating layer 500 may reduce friction between the human tissue and the needle 100.

Therefore, since the silicon coating layer 500 is formed, the needle 100 may be easily invaded into the skin, subcutaneous layer, and blood vessel of the subject, thereby facilitating blood collection and reducing the pain of the subject.

The hub 200 has a hole in which the needle 100 is mounted in the longitudinal direction thereof, and may be disposed to penetrate the needle 100 through the hole. In this case, the hub 200 may be integrally formed with the holder 300. For example, the hub 200 and the holder 300 may be manufactured integrally by the injection method. In another embodiment, the hub 200 and the holder 300 may be manufactured separately and combined with each other by bonding or the like.

Needle 100 may be disposed through the hub 200, and the needle 100 may be fixed to the hub 200 by an adhesive PS. For example, the hub 200 is formed with a through hole into which the needle 100 is inserted, and after the needle 100 is inserted into the through hole, the adhesive PS is bonded around the through hole to connect the needle 100 to the hub ( 200).

In this case, the adhesive PS may be, for example, a heat curable or ultraviolet curable epoxy. For example, needle 100 may be secured to hub 200 by applying epoxy around the aperture and curing the epoxy by heating the epoxy or irradiating the epoxy with ultraviolet light.

Referring to FIG. 2, the hub 200 may include an undercut 201, a small diameter portion 202, and a large diameter portion 203. The undercut 201, the small diameter portion 202, and the large diameter portion 203 may be formed to be sequentially aligned in the longitudinal direction of the hub 200, and a hole through which the needle 100 penetrates may be formed.

The undercut 201 may protrude from the lower end of the small diameter portion 202 into the holder 300, and the sleeve 400 may be mounted on the undercut 201. The undercut 201 will be described in more detail below.

The small diameter portion 202 may protrude from the lower end of the large diameter portion 203. 2, the upper end of the small diameter portion 202 may be coupled to the large diameter portion 203, and the lower end of the small diameter portion 202 may be coupled to the undercut 201. Of course, the undercut 201, the small diameter portion 202, and the large diameter portion 203 may be integrally formed.

The large diameter portion 203 may have a lower end coupled to the small diameter portion 202 and have a diameter larger than that of the small diameter portion 202. Of course, as shown in Figure 2, the lower portion and the upper portion of the large diameter portion 203 may be formed different in diameter.

Adhesive PS is applied to the upper end of the large diameter part 203 to fix the needle 100 to the hub 200, and the small diameter part 202 and the breaking part 210 may be fixed to the lower end of the large diameter part 203. ) May be protruded.

The holder 300 may be coupled to the hub 200, and a portion of the needle 100 may be accommodated. That is, when the needle lower part is received and the needle lower part is inserted into the blood collection tube 10, a part of the blood collection tube 10 is coupled to and received in the holder 300, and at this time, blood flows into the blood collection tube 10. Blood collection can proceed.

Holder 300 may be manufactured in the shape of a cylinder having a space for accommodating the blood collection tube 10, as shown in Figure 1 and 2, to facilitate the receiving of the blood collection tube (10). Correspondingly, the blood collection tube 10 may be manufactured in a piston shape so as to be easily accommodated in the holder 300.

In the state where the needle 100 is inserted into the blood vessel of the subject, a plurality of blood collection tubes 10 are used to relatively collect blood. For example, after one blood collection tube 10 is combined with a holder 300 to complete blood collection, the blood collection tube 10 is removed from the holder 300 and stored, and the other blood collection tube 10 is completed. Re-coupled to the holder 300 may be re-bleed.

To prevent infection, the needle assembly of the embodiment is used only once and discarded, and cannot be used multiple times. Similarly, the blood collection tube 10 can only collect blood once, and multiple blood collection is impossible.

However, the needle assembly of the embodiment is discarded after one use, but the blood collection is possible using a plurality of blood collection tubes 10 when used once. In this case, the use of the needle assembly once means that the continuous action of inserting the needle 100 into the blood vessel of the subject, collecting blood, and removing the needle 100 from the blood vessel again occurs.

On the other hand, in order to suppress the shaking of the holder 300 during the blood collection, as shown in Figure 1, the opposite end of the portion engaging with the hub 200 protrudes in the radial direction of the holder 300 and the hub 200 Surrounding supports may be formed.

The hub 200 and the holder 300 may be made of the same material. For example, the hub 200 and the holder 300 may be formed of a thermoplastic resin. Specifically, the hub 200 and the holder 300 are formed of polyethylene, polyethylene terephthalate, polyvinyl chloride, polyamide, polyvinyl chloride, polyvinylidene chloride, polystyrene, polypropylene, or two or more thereof are mixed. It may be formed of a material.

The sleeve 400 may be accommodated in the holder 300 and may be mounted to the needle 100 to surround a portion of the needle 100 accommodated in the holder 300. That is, the sleeve 400 may be mounted under the needle.

The sleeve 400 is formed of an elastic material and may be formed in a tube shape so as to be fitted to a part of the needle 100. Therefore, the sleeve 400 is manufactured separately and mounted to the lower part of the needle, and the end of the lower part of the needle is made to be bent slightly to prevent the sleeve 400 from tearing when the sleeve 400 is mounted to the lower part of the needle. Can be.

That is, although not shown, for example, the end portion of the bevel portion of the lower part of the needle may be bent in the bevel direction with a constant curvature. Since the bending portion is formed at the end of the needle 100, when the sleeve 400 is mounted on the lower portion of the needle 100, the sleeve 400 can be effectively suppressed from being torn by the sharp portion of the end of the needle 100.

The sleeve 400 is made of, for example, isoprene rubber or natural rubber to have excellent elasticity, thus effectively sealing the hollow of the needle 100 at the distal end of the needle. The sleeve 400 may suppress the leakage of unnecessary blood, thereby suppressing the occurrence of an infection due to the leakage of blood.

For example, when the blood collection tube 10 is not yet coupled to the holder 300 after the needle 100 is inserted into the blood vessel, or when the blood collection tube is completed to remove the blood collection tube 10 from the holder 300. Since the end of the sleeve 400 seals the hollow of the needle 100, it is possible to suppress the leakage of blood to the outside through the needle 100.

In this case, in order to suppress the leakage of blood, as shown in FIG. 2, the sleeve 400 may be disposed to be spaced apart from one end of the needle 100 in a state in which the sleeve 400 is mounted on the needle 100. . Due to this structure, the end of the sleeve 400 can cover the end of the lower needle, so that the sleeve 400 can effectively seal the hollow of the needle 100 at the end of the lower needle.

As shown in FIGS. 2 to 5, the hub 200 may include an undercut 201 to keep the sleeve 400 mounted on the needle 100. . An undercut 201 protrudes into the needle 100, an inner circumferential surface surrounds a portion of the needle 100, and an outer circumferential surface thereof may be mounted with the sleeve 400.

The undercut 201 may be formed at a position corresponding to the through hole through which the needle 100 passes through the hub 200. A portion of the lower needle penetrates the inner circumference of the undercut 201, and one end of the sleeve 400 may be fitted to the outer circumferential surface of the undercut.

Since the elastic sleeve 400 is tightly fitted to the undercut 201, the sleeve 400 is not easily removed from the undercut 201. Due to this structure, the sleeve 400 in the process of blood collection does not leave the needle 100 to close the hollow of the needle 100, thereby preventing blood from leaking to the outside.

In order to more stably maintain the state in which the sleeve 400 is fitted to the undercut 201, the undercut 201 may include a stopper 201a. 2 to 5, the stopper 201a may be formed in the circumferential direction of the undercut 201 and protrude in the radial direction of the undercut 201.

The stopper 201a may be formed asymmetrically in the longitudinal direction of the needle 100. That is, the stopper 201a is formed in an inclined surface and the other side is formed in a stepped surface in the longitudinal direction of the needle 100, and an end of the sleeve 400 may be fitted.

Therefore, when the end of the sleeve 400 is fitted to the stopper 201a, the sleeve 400 moves and deforms along the inclined surface of the stopper 201a, so that the sleeve 400 can be easily fitted to the stopper 201a. On the other hand, when the end of the sleeve 400 is pulled out of the stopper 201a, the sleeve 400 must be moved and deformed along the stepped surface of the stopper 201a, so that it is not easily pulled out of the stopper 201a.

Meanwhile, the hub 200 may include a breaker 210. Referring to FIG. 2, the breaker 210 may be formed at a side of the hub 200 and may be broken by an external impact to divide the hub 200.

As noted above, the needle assembly of the embodiment is used once and discarded. In this case, in order to prevent infection due to the blood collected, it is necessary to separate the needle 100, which is stained with blood, from the holder 300 and then dispose through a separate process such as disinfection and sterilization. Therefore, the needle assembly needs to have a structure in which the needle 100 is easily separated from the holder 300.

In the conventional needle assembly, the needle and the holder are manufactured separately, and the needle is provided with a coupling part for engaging with the holder. The coupling portion and the holder is formed with a thread of a shape corresponding to each other, during the blood collection, the worker screwed the coupling portion of the needle to the holder to proceed with the blood collection, and after completing the blood collection, loosen the screw to separate the needle from the holder The needle was discarded.

In the conventional needle assembly, the worker manually screwed the needle into the holder before collecting blood, and after collecting the blood, unscrewing was performed to separate the needle from the holder. In this case, the blood collection time is long and inefficient, and there is a concern that the worker may be stuck and infected by the needle during the coupling and detachment of the needle.

Therefore, as described above, in the needle assembly of the embodiment is manufactured so that the needle 100 is fixedly coupled to the holder 300, compared to the conventional, the operator omitted the process of coupling the needle 100 to the holder 300 It was. Due to this structure, it is possible to reduce the blood collection time and the operator's effort, and also to prevent the worker from being stuck by the needle 100 in the process of coupling the needle 100 to the holder 300.

In addition, the needle assembly of the embodiment was provided with a fracture portion 210 so that the needle 100 can be easily separated from the holder 300 for disposal after blood collection.

Referring to FIG. 2, the breaker 210 may protrude from a lower end of the large diameter part 203 and may surround the small diameter part 202. Break portion 210 and the small diameter portion 202 may be formed to be spaced apart from each other in the radial direction of the hub (200). That is, the separation space 1000 may be formed between the break portion 210 and the small diameter portion 202.

Since the separation space 1000 is formed, the break portion 210 is separated from the small diameter portion 202, and the groove or through hole (for example, The needle 100 may be easily separated from the holder 300 by forming the first groove, the second groove, and the first through hole.

When an external shock is applied to the needle 100 or the hub 200, a portion where a groove or a through hole, which is the weakest portion of the break portion 210, is formed, is destroyed, and the break portion 210 to the spaced space 1000. When breakage occurs, the needle 100 is separated from the holder 300.

Hereinafter, embodiments of the breaker 210 will be described in detail with reference to the accompanying drawings. Hereinafter, a groove or a through hole formed in the breakout portion 210 will be described to facilitate breakage at the breakout portion 210.

3 is a cross-sectional view for describing a breaker 210 according to an exemplary embodiment. One embodiment of the break portion 210 may be formed in the circumferential direction on the side, and may include a first groove 211 having a V-shaped cross section. The first groove 211 may be recessed in the circumferential direction at the side of the breaker 210.

3 illustrates a structure in which the first groove 211 is continuously formed in the circumferential direction on the side of the break portion 210. In another embodiment, like the second groove 212 illustrated in FIG. 4, the first grooves 211 may be formed in a plurality of parts, i.e., discontinuously at regular intervals in the circumferential direction on the side of the breaker 210. It may be.

When the needle 100 and the holder 300 are separated and disposed, respectively, the process may proceed as follows. External shock is applied to the needle 100 or the hub 200 to the needle assembly to be discarded. The impact occurs in the first groove 211, which is the weakest portion of the hub 200, and thus the hub 200 is divided based on the first groove 211, and thus the needle 100 It may be detached from the holder 300. The separated needle 100 and the holder 300 may be separately disposed and disposed of.

In this case, the external shock may be applied manually by an operator, or may be applied by using an automated disposal device that separates and collects and discards the needle 100.

4 is a cross-sectional view for describing a breaker 210 of another embodiment. Another embodiment of the breaker 210 may include a plurality of second grooves 212 formed in a plurality at regular intervals in the circumferential direction and having a U-shaped cross section. In another embodiment, the second groove 212 may be continuously formed in the circumferential direction on the side of the breaker 210, similar to the first groove 211 shown in FIG. 3. In addition, the second groove 212 may be formed by recessing in the circumferential direction at the side of the break portion 210.

When an external shock is applied to the needle 100 or the hub 200 to the needle assembly to be discarded, a crack occurs in the second groove 212, which is the weakest portion of the hub 200, and the hub 200 is formed in the second groove ( 212, the needle 100 may be separated from the holder 300.

5 is a cross-sectional view for describing a breaker 210 according to still another embodiment. Yet another embodiment of the breaker 210 may include a plurality of first through-holes 213 formed in the side portion at a predetermined interval in the circumferential direction and formed through the side portion.

The hub 200 may be coupled to each other by a partition between the upper and lower portions of the plurality of first through holes 213. Therefore, when an external shock is applied to the needle 100 or the hub 200 to the needle assembly to be discarded, a crack occurs in the partition walls between the plurality of first through holes 213 which are the weakest portions of the hub 200, and the hub The 200 may be divided based on the through hole, and the needle 100 may be separated from the holder 300.

In an embodiment, the needle 100 can be easily removed from the holder 300 by applying an external shock to the needle assembly to be disposed of, and a worker separates the needle 100 and the holder 300 manually screwed from each other. The process can be omitted. Due to this structure, it is possible to reduce the blood collection time and the effort of the operator, and also to suppress the infection of the worker stuck to the needle 100 in the process of separating the needle 100 and the holder 300 from each other.

6 is a flowchart illustrating a method of manufacturing a needle assembly according to one embodiment. Needle assembly manufacturing method is a hub supply step (S100), needle supply step (S200), needle insertion step (S300), bonding step (S400), silicon coating step (S500), inspection step (S600) and sleeve 400 mounting It may include a step.

In the hub supply step S100, the hub 200 may be supplied. In this case, as described above, the hub 200 may include a fracture portion 210 formed at the side portion and broken by external impact to divide the hub 200. In addition, the hub 200 and the holder 300 may be provided integrally. Accordingly, when the hub 200 is supplied, the holder 300 integral with the hub 200 may be supplied together.

The needle 100 is inserted into and coupled to the supplied hub 200. The needle 100 may be supplied such that the needle 100 is disposed at a position at which the needle 100 is inserted in the hub 200.

In the needle supply step S200, the needle 100 may be supplied. In the needle supply step S200, in order to arrange the needle 100 at the insertion position of the hub 200, the needle 100 may include the following steps.

7 is a flow chart for explaining the needle supply step (S200) in the needle assembly manufacturing method of an embodiment. The needle supply step S200 may include a needle alignment step S210, a needle suction step S220, and a needle disposition step S230.

In the needle supply step S200, since the prepared needle 100 is prepared to be coupled to the hub 200, an apparatus for moving and placing the needle 100 is used. For example, although not shown, a needle insertion device having a needle alignment device or a vacuum means may be used as a device for moving and arranging the needle 100.

In the needle sorting step S210, the needle sorting device may sequentially sort the plurality of the needles 100. The needle insertion device can hold and move the aligned needle 100.

In the needle suction step (S220), the needle insertion device may suck the needle 100 aligned using the vacuum means. In the embodiment, the needle insertion device uses the vacuum means to suck and hold the needle 100 in a suctioned manner in order to move the needle 100, and to insert the needle 100 into the hub 200. The needle 100 may be moved to the set position.

In the needle disposition step S230, the needle insertion apparatus may arrange the needle 100 at a position corresponding to the needle insertion portion of the hub 200. The needle insertion device grips the needle 100 using a vacuum means, and moves the gripped needle 100 to the set position of the hub 200 to complete the preparation for inserting the needle 100 into the hub 200. do.

In the needle insertion step S300, the needle insertion device may insert the needle 100 into the hub 200. In this case, the needle lower part may be accommodated in the holder 300.

In the bonding step (S400), the needle 100 may be fixedly coupled to the hub 200 with an adhesive PS in a state where the lower needle is accommodated in the holder 300. In this case, the adhesive PS may be a thermosetting or ultraviolet curable epoxy as described above.

The adhesive PS may be applied and cured on the adhesive portion between the needle 100 and the hub 200. In this case, when the adhesive PS is a heat curable epoxy, it may be cured by heating, and when the adhesive PS is an ultraviolet curable epoxy, it may be cured by irradiation of ultraviolet rays.

In the silicon coating step S500, the silicon coating layer 500 may be formed on a portion exposed to the outside of the needle 100, that is, on the needle. In this case, the silicon coating layer 500 may be formed by applying and curing silicone to the outer surface of the needle upper part.

In the inspection step (S600), the adhesion and the defect of the silicon coating layer 500 can be inspected. Specifically, the operator may visually determine whether there is a defect by inspecting the adhesive state of the adhesive PS between the needle 100 and the hub 200 and the state of the silicon coating layer 500.

In addition, it may be determined whether the needle 100 is blocked by the adhesive PS or silicon to cause a defect. It may be determined whether there is a defect in the coupling state between the other needle 100 and the hub 200. If a defect occurs, the defective product is extracted and discarded, and then the needle assembly is manufactured.

In the mounting of the sleeve 400, the sleeve 400 may be mounted on a portion of the needle 100. The sleeve 400 may be mounted under the needle.

8 is a view for explaining a process after the mounting step of the sleeve 400 in the needle assembly manufacturing method of an embodiment. Needle assembly manufacturing method of the embodiment may further include a cap coupling step (S810), labeling step (S820) and sterilization step (S830) after the mounting step of the sleeve 400.

In the cap coupling step (S810), it is possible to couple the cap to the needle (100). In order to protect the needle 100 in the manufactured needle assembly, a cap (not shown) may be coupled to the needle 100. The cap may be coupled to the upper needle and the lower needle, respectively.

In the labeling step S820, the needle assembly may be labeled. In other words, it is possible to attach the label to the needle assembly. The label may be attached to the outer surface of the holder 300, for example.

In sterilization step (S830), it is possible to sterilize the needle assembly. In this case, sterilization may be performed by, for example, EOG sterilization method of exposing the needle assembly to ethylene oxide gas (EOG).

As described above in connection with the embodiment, only a few are described, but other forms of implementation are possible. Technical contents of the above-described embodiments may be combined in various forms, unless the technology is incompatible with each other, and may be implemented in a new embodiment.

10: blood collection tube
100: needle
200: hub
201: undercut
202: small diameter
203: big neck
201a: stopper
210: breaking
211: first groove
212: second groove
213: First Passage
300: holder
400: sleeve
500: silicon coating layer
PS: Glue
1000: separation space

Claims (12)

Hollow needles;
A hub disposed to penetrate the needle;
A holder coupled to the hub, the holder receiving a portion of the needle; And
A sleeve received in the holder and mounted to the needle to surround a portion received in the holder of the needle
Including,
The hub,
And a break formed in the side and broken by an external impact to divide the hub. The method of claim 1,
The hub and the holder are integrally formed, and the needle is fixed to the hub by an adhesive. The method of claim 2,
The adhesive,
Needle assembly, characterized in that the heat-curable or ultraviolet curable epoxy. The method of claim 1,
The sleeve,
It is formed of an elastic material and formed into a tube shape so as to fit in a portion of the needle,
And a needle end, the end of the needle assembly being spaced apart from one end of the needle. The method of claim 4, wherein
The hub,
Protrudes into the holder, an inner circumferential surface surrounds a portion of the needle, and an outer circumferential surface includes an undercut on which the sleeve is mounted;
The undercut,
One side is formed with an inclined surface and the other side is formed with a stepped surface, the needle assembly, characterized in that the stopper is fitted to the end of the sleeve is fitted. The method of claim 1,
The needle,
Needle assembly, characterized in that the silicon coating layer is formed on the insertion site of the blood vessel of the subject. The method of claim 1,
The breaking portion,
Needle assembly, characterized in that the side portion is formed in the circumferential direction, the first groove having a V-shaped cross section. The method of claim 1,
The breaking portion,
Needle assembly, characterized in that the side portion is formed in a plurality in the circumferential direction at regular intervals, the second groove having a cross-section of the U. The method of claim 1,
The breaking portion,
A needle assembly, characterized in that it comprises a plurality of first through-holes formed in the side portion at regular intervals in the circumferential direction, and penetrating the side portion. A hub supply step of supplying a hub;
A needle supplying step of supplying a needle;
A needle insertion step of inserting the needle into the hub;
Bonding the needle to the hub with an adhesive;
A silicon coating step of forming a silicon coating layer on a portion exposed to the outside of the needle;
An inspection step of inspecting adhesion and defects of the silicon coating layer; And
Sleeve mounting step of mounting a sleeve on the part of the needle
Including,
The hub,
A needle assembly manufacturing method comprising a fracture portion formed in the side portion and broken by an external impact to divide the hub. The method of claim 10,
The needle supply step,
A needle sorting step in which a needle sorting device sequentially sorts the plurality of the needles;
A needle suction step of a needle insertion device for sucking the needles aligned using vacuum means; And
A needle disposition step of disposing the needle at a position corresponding to the needle insertion portion of the hub by the needle insertion apparatus;
Needle assembly manufacturing method comprising a. The method of claim 10,
After the sleeve mounting step,
A cap coupling step of coupling the cap to the needle;
A labeling step of labeling the needle assembly; And
Sterilization step to sterilize the needle assembly
Needle assembly manufacturing method comprising a further.

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