JP6210718B2 - How to assemble a medical safety needle - Google Patents

Description

  The present invention relates to a method for assembling a medical needle, and more particularly to a method for assembling a medical safety needle that prevents re-exposure of a needle tip after use.

  Various medical needles are used for the purpose of introducing a medical solution or a catheter into a patient's body. After its use, the patient's blood or body fluid adheres to the medical needle, which can rarely be a factor that mediates infection. In order to prevent infection, an instrument for shielding the needle after use has been proposed. Patent Document 1 discloses a related technique.

  As an opportunity for infection, first, unintentional injury by the needle tip, but by touching the side of the needle, blood or bodily fluid adheres to the body, and this is secondary to the mouth or wound. There can be infection. The instrument disclosed in Patent Document 1 includes not only a front part that covers the needle tip to prevent the former risk, but also a flexible part that covers the side surface of the needle to prevent the latter risk.

International Publication WO92 / 18182

  As can be easily understood from the drawings of Patent Document 1, many parts of a safety needle must be fitted around an elongated puncture needle, and the assembly includes a step of sequentially passing these parts through the puncture needle. . Unlike other parts made of a hard material such as metal or resin, a flexible sleeve such as a flexible part is not form-stable, and this makes the process difficult. If a needle or other component damages the sleeve, its original function may be impaired, and a corresponding process is required to try to penetrate the sleeve without scratching, resulting in productivity problems. . The present invention has been made in view of such problems.

A safety needle assembling method comprising a needle, a cover that covers the needle tip, a sleeve that covers a side surface of the needle, and a handle that supports the needle, the cover is fitted to the needle or a guide pin, The cover and the needle or the guide pin are pressed against a film stretched parallel to the needle or the guide pin, the cover and the needle or the guide pin are further advanced with a part of the film, and the needle or The film is bonded to the film itself so as to surround the guide pins to form a film tube. At the same time as or after bonding the film, the film tube is separated from the film to form the sleeve. The sleeve is coupled to the cover, and the sleeve and the needle coupled to the cover are inserted into the handle. Bonding said sleeve to said handle, consists in.

  It can be incorporated into the safety needle with high productivity without damaging the flexible sleeve.

FIG. 1 is a plan view outlining a medical safety needle and its usage according to an embodiment of the present invention. FIG. 2 is an exploded plan view of the medical safety needle. FIG. 3 is a perspective view illustrating one process of manufacturing a medical safety needle. FIG. 4 is a plan view showing one process of manufacturing a medical safety needle. FIG. 5 is a cross-sectional view showing a state in which the film shrinks around the cover and the guide pin. FIG. 6 is a cross-sectional view illustrating a process of inserting a needle into the cover. FIG. 7 is a plan view showing a process of incorporating the sleeve into the handle together with the cover.

  Several exemplary embodiments of the present invention are described below with reference to the accompanying drawings.

  Throughout the following description and the appended claims, the term axial is defined and used as the direction of the needle, and the term radial is defined and used as the direction orthogonal thereto.

  The assembly method according to the present embodiment can be suitably applied to the assembly of a catheter introducer used for the purpose of introducing a liquid such as a medicine or a tube such as a catheter into a patient's body. One such example is the medical safety needle 1 illustrated in FIG. Such a catheter introducer can be applied not only to a human but also to any living thing, and also to an object, and such an assembling method can be applied not only to a catheter introducer but also to an assembly of, for example, a blood collection needle, an indwelling needle, or a syringe. .

  Referring to FIG. 1, a medical safety needle 1 generally includes a handle 3 that supports a needle for puncturing a patient's body, a cover 5, a catheter body 7 that is placed in the patient's body after puncturing, and more. Become. In the initial state shown in FIG. 1 (a), the needle penetrates the catheter body 7 and its tip is slightly exposed to the outside, which is used for puncture. After use, when the cover 5 is pulled out as shown in FIG. 1B, the sleeve 10 is pulled out accordingly. When the cover 5 is pulled out to the foremost position together with the sleeve 10 as shown in FIG. 1 (c), the catheter body 7 is detached and used for infusion, etc. The cover 5 and the sleeve 10 cover the needle, Prevent the patient from touching the needle tip or the side of the needle unintentionally.

  The configuration of the medical safety needle 1 will be described in more detail with reference to FIG.

  The needle 3a is fixed to the handle 3 and extends forward in the axial direction. The handle 3 is preferably provided with an opening 3W on its side surface, and the opening 3W is used for the convenience of fixing the needle 3a and the convenience of adhering the sleeve 10.

  The cover 5 and its accessory parts 5a and 5b and the sleeve 10 are accommodated in the handle 3 after being fitted to the needle 3a. The accessory parts 5 a and 5 b include a part 5 a to be inserted from the back of the cover 5 and a part 5 b to be inserted from the front of the cover 5. Examples of the components included in these include a locking body and a spring for locking the cover 5 to the needle tip, but there may be various configurations. The spring is made of metal or spring resin. Other parts are made of resins having appropriate strength and elasticity. Examples of such resins include polyoxymethylene (POM), polyetheretherketone (PEEK), high density polyethylene (HDPE), and polyamide (PA). Polycarbonate (PC), polyethylene terephthalate (PET), polyvinyl chloride (PVC), low density polyethylene (LDPE) and the like.

  The sleeve 10 is preferably made of a heat-shrinkable resin. Examples of such a resin include polyolefin, polytetrafluoroethylene (PTFE), polyvinyl chloride (PVC), polyethylene terephthalate (PET), and fluorine-based resin.

  A general indwelling catheter can be applied to the catheter body 7, or this is omitted.

  The medical safety needle 1 is assembled by the apparatus shown in FIGS. Referring to FIG. 3, the sleeve 10 is provided in the form of a long film 11 wound on a roll prior to assembly. A pair of bobbins 21 are provided to supply the film 11. Or it replaces with one side of the bobbin 21, and the pin and other structure which support the edge of the film 11 may be provided. In any case, the film 11 is provided in a stretched state as shown in the drawing. Preferably, a plurality of pins 23 parallel to the bobbin 21 are provided to meander the film 11 and apply an appropriate tension. The pin 23 is not limited to a fixed one, but may be in the form of a dancer to prevent the film 11 from loosening.

  A pallet 27 is provided so as to be movable in a direction (arrow A) intersecting the direction in which the film 11 travels. The assembly apparatus includes a guide way 29 for guiding the movement. Further, a guide 25 extending from the pallet 27 is provided in parallel to the surface of the film 11, and the tip thereof is configured so that the cover 5 can be fitted.

  FIG. 4 is a plan view of the assembling apparatus from above, in which the cover 5 is omitted. A cutter 31 is provided on the downstream side in the direction of arrow A from the position where the film 11 travels, with the guide way 29 interposed therebetween. The cutters 31 are movable so as to approach and separate from each other. The cutter 31 has an appropriate heating means, and the film 11 is welded and melted by heating.

  The cutter 31 may be in the form of a tank 33 that wraps the guide 25 as shown. Moreover, the tank 33 may be configured so as to ensure a space in which an appropriate gap can be held with respect to the guide 25, and further configured so that hot air can be sent to the space. Alternatively, the cutter 31 may be separate from the tank 33 and may be disposed upstream of the tank 33 with respect to the flow of the pallet 27.

  As shown in FIG. 3, the cover 5 is fitted to the tip of a guide 25 extending from a movable pallet 27. At this time, the part 5a to be inserted from the back should be assembled to the cover 5, and the part 5b to be inserted from the front may also be assembled. The guide 25 may be fixed to the pallet 27 in advance, or the guide 25 is fitted into the cover 5 in advance and waits at an appropriate position in the apparatus, and the pallet 27 that has moved moves this. It may be a mode of receiving.

  Alternatively, the needle 3a can be used instead of the guide 25. Hereinafter, the case where the guide 25 is used will be described. However, the embodiment can be similarly implemented by replacing the guide 25 with the needle 3a.

  The film 11 is supplied from the bobbin 21. Preferably, a plurality of pins 23 parallel to these pins are meandered so as to be properly stretched and held parallel to the guide 25. As shown in FIG. 4A, when the pallet 27 moves in the direction of the arrow A, the cover 5 and the guide 25 are pressed against the film 11 stretched in parallel thereto.

  The pallet 27 further moves in the direction of arrow A, and the cover 5 and the guide 25 arrive at a position where the tank 33 stands by as shown in FIG. 4 (b) with a part of the film 11, and stop at this position. To do.

  As shown in FIG. 4C, the cutters 31 are brought close to each other and are in close contact with each other. The film 11 is adhered on the back side of the cover 5 and the guide 25 to form a cylindrical shape. Adhesion is, for example, welding by heating with the cutter 31, but may be performed with an adhesive or other means. By bonding, the film 11 forms a cylindrical film tube 11 </ b> A that surrounds the cover 5 and the guide 25.

  At the same time as or after bonding, the film tube 11A is separated from the main body of the film 11 by the cutter 31 to form the sleeve 10. The cutting process may be cutting by close contact of the cutter 31 or may be fusing by heating. Fusing can be performed simultaneously with welding. The cutting is not limited to a straight line, but may be a zigzag meandering form. Since the cut film 11 is connected at the adhesion point 11B, it is continuously used for assembling the safety needle 1.

  Then, the space may be surrounded around the guide 25 by the tank 33. If the cutter 31 and the tank 33 are integrated, this can be done simultaneously with the cutting process. If hot air is blown into the space surrounded by the tank 33, the film tube 11 </ b> A can be contracted around the cover 5 and the guide 25 by heating the hot air. The heating temperature and time are appropriately adjusted in view of the degree of shrinkage.

  Next, the tank 33 is pulled away, and the pallet 27 is moved in the direction of the arrow A, so that it is carried out as shown in FIG. As apparent from FIG. 4A, the apparatus can start the next assembly without interruption.

  The state after contraction is as shown in FIG. As is clear from the above description, the film tube 11A contracts in a state of also surrounding the cover 5, so that one end 10F of the sleeve 10 is in close contact with the periphery of the cover 5 and is thus coupled thereto. Preferably, the degree of contraction is adjusted so that an appropriate margin is generated between the sleeve 10 and the guide 25.

  In order to reinforce the connection between the cover 5 and the sleeve 10 due to heat shrinkage or to bond them in place of the heat shrinkage, a twist may be applied to one end 10F of the sleeve 10. Twisting may be performed at a later step rather than at this stage.

  Alternatively, an adhesive or an adhesive tape may be interposed between the cover 5 and the sleeve 10. The adhesive may be applied to the film 11 in advance. If a thermoplastic adhesive is used, thermal shrinkage and adhesion can occur simultaneously. Further, a structure such as a protrusion, a groove, a dent, a constriction, or a spiral may be formed on the outer periphery of the cover 5. Alternatively, as shown in FIG. 5B, a ring 41 such as an elastic body may be covered. The ring 41 can be in the form of an O-ring or a C-ring. The C-ring is advantageous in that it can be placed over the sleeve 10 from the side.

  In the state shown in FIG. 5, the tip of the component 5b is closed, but when the guide 25 is pushed slightly forward from this state, the tip of the component 5b is opened as shown in FIG. 6 (a). Through this opening, the needle 3a is inserted into the cover 5 and the sleeve 10 from its proximal end 3e. Further, as shown in FIG. 6B, the guide 25 is removed, and the base end 3 e reaches the handle 3.

  The handle 3 is provided with a hole having a so-called tight fit relationship with the needle 3a, and the proximal end 3e of the needle 3a is fixed as shown in FIG. Of course, an adhesive or other means may be used. The fixing between the sleeve 10 and the handle 3 can also be performed by an adhesive. As the adhesive, an instantaneous adhesive can be used, or a UV curable adhesive can be used, and it can be adhered by separately irradiating it with ultraviolet light. For convenience of injecting the adhesive, the opening 3W on the side surface of the handle 3 can be used. In place of the adhesive, high frequency welding or sonic welding can be used.

  Preferably, the direction of the blade surface of the needle tip of the needle 3a is directed in a specific direction with respect to the opening 3W on the side surface of the handle 3. The opening 3W can be used as a marker for the user to confirm the orientation of the blade surface during use.

  By moving the cover 5 along the needle 3a in the direction of the handle 3 and storing it in the handle 3, the assembly of the medical safety needle 1 is almost completed. If necessary, the catheter body 7 is assembled, and its proximal end is engaged with the cover 5.

  According to the present embodiment, in the process of inserting the needle, the proximal end thereof passes through the sleeve, and the needle tip does not pass through the sleeve. When inserting the needle into the sleeve, it can be guided to the guide pin. Even when a needle is used instead of the guide pin, the needle tip does not pass through the sleeve. In any case, there is no risk of the sleeve being damaged by the needle tip. Since the film stretched between the bobbins can be used for repetitive assembly, continuous and efficient production is possible.

  Although the present invention has been described with reference to preferred embodiments, the present invention is not limited to the above-described embodiments. Based on the above disclosure, a person having ordinary skill in the art can implement the present invention by modifying or modifying the embodiment.

  A method for assembling a medical safety needle that can be incorporated into a safety needle without damaging the flexible sleeve is provided.

1 Needle Assembly 3 Handle 3a Needle 5 Cover 7 Catheter Body 10 Sleeve 11 Film 21 Bobbin 25 Guide 27 Pallet 31 Cutter 33 Heating Tank

Claims (5)

A safety needle assembling method comprising a needle, a cover that covers the needle tip, a sleeve that covers a side surface of the needle, and a handle that supports the needle,
Fitting the cover to the needle or guide pin;
Pressing the cover and the needle or the guide pin against a film stretched parallel to the needle or the guide pin;
The cover and the needle or the guide pin are further advanced with a part of the film,
A film tube is formed by adhering the film to the film itself so as to surround the needle or the guide pin,
At the same time as or after bonding the film, the film tube is separated from the film to form the sleeve,
Coupling the sleeve to the cover;
Inserting the sleeve and the needle coupled to the cover into the handle;
Bonding the sleeve to the handle;
An assembly method comprising: The assembly method according to claim 1,
The assembly method further comprises shrinking the film tube around the cover and the needle or the guide pin. The assembly method according to claim 1 or 2,
The step of adhering the film is an assembly method by heat welding. An assembly method according to any one of claims 1 to 3,
The step of shrinking the film tube is an assembly method by heating. An assembly method according to any one of claims 1 to 4,
An assembling method in which, in the step of separating the film tube, the cut is meandered in a zigzag manner with respect to the axial direction of the needle.

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