JP6914153B2 - Needle assembly for ampoule formulation - Google Patents

Description

The present invention relates to an ampoule-formulating needle assembly that sucks a chemical solution from an ampoule.

Generally, an ampoule is known as a container for storing a drug solution, but when the drug solution is aspirated from the ampoule, it is generally aspirated using a syringe. However, since the needle tip attached to the tip of the syringe is sharp, the needle tip may be deformed by hitting the inner wall of the ampoule during suction. In this case, when an attempt is made to puncture a patient by using a needle with a deformed needle tip as it is, there is a problem that the puncture property deteriorates due to the deformation and pain increases. In order to solve this problem, as in Patent Document 1, an instrument capable of replacing a sharp needle of a syringe with a hollow cylinder is disclosed.

Japanese Unexamined Patent Publication No. 8-299440

The instrument disclosed in Patent Document 1 has problems that the hollow cylinder and the needle must be replaced after suction, the needle is stuck in the finger when the replacement is performed, and the chemical solution is scattered when the replacement is performed. rice field.

The present invention has been made in consideration of such problems, and an object of the present invention is to provide a needle assembly for an ampoule preparation capable of improving convenience and reducing the risk of chemical solution scattering and needle stick accident during use. And.

In order to achieve the above object, the needle assembly for ampoule formulation of the present invention has an inner needle having a needle tip, a tip portion located on the tip side of the needle tip and having a blunt tip, and at least the above. An outer cylinder that covers the periphery of the needle tip is provided, and the outer cylinder and the inner needle are inserted through the opening of the ampoule, and the drug solution of the ampoule is sucked through the outer cylinder and the inner needle, and then the outer cylinder is provided. The cylinder is configured so that the tip of the inner needle can be exposed, and the tip of the outer cylinder has a plurality of convex portions protruding with respect to the central axis direction of the outer cylinder. It is characterized in that the shape of the tip portion of the outer cylinder is a trumpet shape.

According to the needle assembly for ampoule formulation having the above configuration, when the drug solution is sucked from the ampoule, the needle tip is covered with the outer cylinder, so that the risk of needle stick accident of the user can be reduced. .. Since the needle assembly for ampoule preparation can easily shift to a state in which the needle tip is exposed after sucking the chemical solution, it is possible to improve convenience at the time of use and reduce the risk of chemical solution scattering. Further, it is possible to prevent the needle tip from being deformed by hitting the inner wall of the ampoule during suction. Further, with the above configuration, even when the tip of the outer cylinder is located on the bottom surface of the ampoule, the chemical solution can be reliably sucked from the gap of the convex portion. In addition, with the above configuration, it is possible to suck up to the last drop of droplets adhering to the ampoule by pushing the outer cylinder.

The outer cylinder may be detachable from the needle.

With this configuration, the outer cylinder to which the chemical solution is attached can be removed, and puncture and chemical solution injection can be performed in a clean state.

The outer cylinder may be movable relative to the inner needle in the insertion direction.

With this configuration, the outer cylinder can be detached with a simple operation.
An outer cylinder hub may be provided at the base end of the outer cylinder.

With this configuration, the outer cylinder can be reliably operated by sandwiching the outer cylinder hub.

The outer cylinder hub may have an umbrella portion that prevents the liquid adhering to the outer cylinder from entering the inner needle hub side.

With this configuration, it is possible to prevent the liquid adhering to the outer cylinder after suctioning the chemical solution from adhering to the user's hand along the outer cylinder.

The inner needle has an inner needle hub fixed to the base end portion of the inner needle, and the outer cylinder hub may be fitted with the inner needle hub in an assembled state.

With this configuration, since the needle tip does not move due to the fitting of the outer cylinder hub and the inner needle hub, the chemical solution can be sucked without exposing the needle tip from the outer cylinder.

The inner space of the outer cylinder may have a filter for preventing glass fragments and / or foreign matter of the ampoule from passing through.

With this configuration, it is possible to prevent foreign substances and the like from being mixed into the sucked chemical solution.

The surface of the outer cylinder may have water repellency or hydrophobicity.

With this configuration, it is difficult for the chemical solution to adhere to the outer cylinder after suctioning the chemical solution, so that the outer cylinder can be kept in a clean state.

According to the needle assembly for ampoule preparation of the present invention, it is possible to prevent the needle tip from being deformed by hitting the inner wall of the ampoule during suction. The needle assembly for an ampoule formulation of the present invention can improve convenience at the time of use and reduce the risk of chemicals scattering and needle stick accidents.

It is a schematic side view of the needle assembly for an ampoule formulation which concerns on 1st Embodiment of this invention. It is a schematic side view of the needle assembly for an ampoule formulation which concerns on 2nd Embodiment of this invention. It is a figure which shows the use state of 1st Embodiment of this invention. It is a side view of the needle assembly for an ampoule formulation after suction of a chemical solution in 1st Embodiment of this invention. It is sectional drawing of the outer cylinder hub in this invention. It is a figure which shows the side surface of another aspect A of the tip shape of the outer cylinder in this invention. It is a figure which shows the side surface of another aspect B of the tip shape of the outer cylinder in this invention. It is a figure which shows the side surface of another aspect C of the tip shape of the outer cylinder in this invention. It is a figure which shows the side surface of another aspect D of the tip shape of the outer cylinder in this invention. It is a figure which shows the state which the tip of the outer cylinder shown in FIG. 7 is positioned on the bottom surface of an ampoule. It is a figure which shows the state which the tip of the outer cylinder shown in FIG. 8 is positioned on the bottom surface of an ampoule. It is a figure which shows the state which the tip of the outer cylinder shown in FIG. 9 is positioned on the bottom surface of an ampoule. It is a figure which shows the state which the tip of the outer cylinder shown in FIG. 10 is positioned on the bottom surface of an ampoule.

Hereinafter, a plurality of suitable embodiments of the needle assembly for an ampoule formulation according to the present invention will be described with reference to the accompanying drawings.
First, a first embodiment of the ampoule-formation needle assembly of the present invention will be described with reference to FIGS. 1 to 5.

As shown in FIG. 1, the ampoule preparation needle assembly 1 has an inner needle 10 having a needle tip 14, and a tip portion 26 located on the tip side of the needle tip 14 and having a blunt tip, and the needle tip 14 It is provided with an outer cylinder 20 that covers the periphery of the. An inner needle hub 12 is provided at the base end of the inner needle 10.

The inner needle 10 may be made of any material as long as it has hardness and toughness that can withstand insertion into the body. For example, a metal material such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, or a hard resin. , Ceramics and the like can be preferably used.

The material of the outer cylinder 20 is preferably a resin material, particularly a soft resin material. In this case, for example, a fluororesin such as polytetrafluoroethane (PTFE), an ethylene / tetrafluoroethane copolymer (ETFE), a bellfluoroalkoxyfluororesin (PFA), an olefin resin such as polyethylene or polypropylene, or an olefin resin such as polyethylene or polypropylene. Examples thereof include a mixture thereof, polyurethane, polyester, polyamide, polyether polyamide resin, and a mixture of the olefin resin and an ethylene-vinyl acetate copolymer. The outer cylinder 20 may be made of a transparent resin so that the inside of all or part of the cylinder 20 can be visually recognized.

The maximum value of the catheter repulsive force is preferably 0.06 N or more. More preferably, it is 0.18 N or more. In the present specification, the maximum value of the catheter repulsive force is obtained by performing a three-point bending test using a catheter having a tube length of 20 mm under the conditions of a distance between fulcrums of 15 mm, a pushing distance of 1.5 mm, and a pushing speed of 20 mm / min. It is the value of the repulsive force that was given. An autograph (EZ-L, manufactured by Shimadzu Corporation) is used to measure the catheter repulsive force.

The surface of the outer cylinder 20 has water repellency or hydrophobicity. A surface having water repellency or hydrophobicity can be realized by coating a material having water repellency or hydrophobicity such as silicone oil, fluorine, or ceramic, or by forming minute irregularities on the surface.

An outer cylinder hub 22 is provided at the base end of the outer cylinder 20. The outer cylinder 20 and the outer cylinder hub 22 are hollow, and the inner needle 10 is inserted through the outer cylinder 20 and the outer cylinder hub 22 in the assembled state before sucking the chemical solution. The inner needle 10 is entirely covered with the outer cylinder 20 and the outer cylinder hub 22. Therefore, the needle tip 14 is located in the internal space of the outer cylinder 20.

FIG. 5 is a cross-sectional view of the outer cylinder hub 22. The hollow portion of the outer cylinder hub has a tapered shape whose diameter gradually decreases toward the tip, and can be fitted with the inner needle hub 12. An umbrella portion 24 is provided on the outer circumference of the outer cylinder hub 22. The umbrella portion 24 has a disk-shaped proximal end surface portion 28 extending on the proximal end side of the outer cylinder hub 22, and a protrusion extending in the distal end direction is provided on the entire outer edge of the proximal end surface portion 28.

In the assembled state, the outer cylinder hub 22 is fitted with the inner needle hub 12. The inner diameter of the outer cylinder 20 and the outer diameter of the inner needle 10 are substantially the same, and the space between the inner needle 10 and the outer cylinder 20 is liquid-tight. By disengaging the outer cylinder hub 22 and the inner needle hub 12, the outer cylinder 20 can slide with respect to the inner needle 10. By advancing the outer cylinder 20 in the insertion direction, the outer needle 10 can be separated from the inner needle 10.

In the present embodiment, the inner diameter of the outer cylinder 20 is substantially the same as the outer diameter of the inner needle 10, but the inner diameter of the outer cylinder 20 may be larger than the outer diameter of the inner needle 10. In that case, the inner peripheral surface of the outer cylinder 20 or a part of the outer surface of the inner needle 10 may be in contact with each other, and for example, an annular protrusion may be provided. The protrusion fills the gap between the outer cylinder 20 and the inner needle 10 to make it liquidtight. Further, by reducing the contact area between the outer cylinder 20 and the inner needle 10, the slidability of the outer cylinder 20 with respect to the inner needle 10 is improved.

A filter 21 is provided at the tip of the outer cylinder 20. The filtration member 21A is used as the filter 21 in this embodiment. The filtration member 21A is located inside and / or near the tip of the outer cylinder 20.
The filtration member 21A may pass through the air and the chemical solution, but may capture foreign matter and debris of the ampoule contained in the chemical solution in the ampoule. For example, a sintered body, a non-woven fabric, a filter paper, a membrane, or the like that meets the above conditions is preferable.

Next, a method of using the present invention will be described with reference to FIGS. 3 and 4.

First, a syringe 50 for sucking the chemical solution 40 is prepared and attached to the inner needle hub 12. The attachment may be fitting, screwing with a screw portion, or the like.
Next, an ampoule 30 having an opening 32 is prepared by opening the package. The outer cylinder 20 is inserted into the ampoule 30 through the opening 32 of the ampoule 30, and the tip portion 26 is arranged in the chemical solution 40. Since the needle tip is located in the internal space of the outer cylinder 20, it does not come into contact with the user or the bottom surface 34 of the ampoule 30. Since the outer cylinder hub 22 is fitted with the inner needle hub 12, the outer cylinder 20 does not move and the needle tip moves toward the tip side and is not exposed to the outside unless a force is applied to the fitting portion. .. In addition, since the tip of the outer cylinder 20 is blunted, it is unlikely that the outer cylinder 20 will damage the surface of the ampoule 30 or the skin of the user. Therefore, the user can safely inhale the chemical solution 40.

Since the filtration member 21A is provided at the tip of the outer cylinder 20, the suction port of the outer cylinder 20 is not completely blocked by the bottom surface 34 of the ampoule 30 or the like.

Next, the chemical solution 40 is sucked by pulling in the pusher 52. Since the filtering member 21A filters foreign substances (glass pieces of ampoules, suspended fine particles, etc.) that have entered the chemical solution 40, there is no concern that foreign substances may be mixed into the injected chemical solution 40. Therefore, the chemical solution 40 can be sucked in a simple and safe state.

The chemical solution 40 travels through the outer cylinder 20 and reaches the vicinity of the needle tip 14, but since the space between the inner needle 10 and the outer cylinder 20 is liquid-tight, the chemical liquid 40 collects between the inner needle 10 and the outer cylinder 20. Or, the chemical solution 40 does not leak to the outside through the outer cylinder hub 22. Therefore, the risk that the drug solution 40 adheres to the user or the patient can be reduced.

Since the surface of the outer cylinder 20 is provided with a water-repellent or hydrophobic coating, the chemical solution 40 is less likely to adhere when the outer cylinder 20 is pulled out from the ampoule 30.

After the suction of the chemical solution 40 is completed, the outer cylinder 20 is taken out from the ampoule 30. Next, a force is applied to the fitting portion between the outer cylinder hub 22 and the inner needle hub 12 to release the fitting, so that the outer cylinder 20 is slidable with respect to the inner needle 10. Since the outer cylinder hub 22 is provided with an umbrella portion 24, when the outer cylinder 20 is removed, the chemical solution 40 adhering to the vicinity of the tip of the outer cylinder 20 travels along the outer surface of the outer cylinder 20 to the outer cylinder hub. Even when the liquid has flowed up to 22, the umbrella portion 24 can block the flow of the chemical solution 40 toward the proximal end portion.

The details of the disengagement of the outer cylinder hub 22 and the inner needle hub 12 are as follows. The outer cylinder hub 22 is sandwiched, and the outer cylinder 20 is surely pushed forward toward the tip end. By pushing the outer cylinder hub 22 toward the tip side of the needle tip 14, the outer cylinder 20 and the outer cylinder hub 22 can be easily separated from the inner needle 10. At this time, the outer cylinder 20 may be advanced by pushing out the base end surface portion 28 of the umbrella portion 24 instead of the outer cylinder hub 22. The fitting of the outer cylinder hub 22 and the inner needle hub 12 can be released and the outer cylinder 20 can be advanced by a simple operation, and the convenience can be improved.

In order to push the outer cylinder 20 forward, a force may be applied to the base end surface portion 28, or the outer peripheral portion of the umbrella portion 24 may be gripped and pushed forward. The outer peripheral portion may be provided with irregularities to facilitate gripping.
A member other than the umbrella portion may be provided on the outer surface of the outer cylinder hub in order to push the outer cylinder forward. For example, by providing a protrusion, pinching the protrusion and pushing the outer cylinder 20 forward, the possibility that the user touches the chemical solution 30 can be further reduced.

FIG. 4 is an overall view of the syringe 50 to which the inner needle 10 and the inner needle hub 12 are attached after the chemical solution 40 is sucked and the outer cylinder 20 and the outer cylinder hub 22 are removed.
Since the outer cylinder 20 and the outer cylinder hub 22 to which the chemical solution 40 is attached are separated, puncture and injection can be performed in a clean state. Further, the needle tip 14 is exposed, and is ready for puncture and injection of the drug solution 40 immediately.

FIG. 2 is a schematic side view of another embodiment (second embodiment) of the present invention. The difference from the first embodiment in the needle assembly 100 for ampoule preparation in the present hands-on form is that a filter 21B is provided as a filter in the middle portion of the outer cylinder 20.
The filter 21B includes a disk-shaped housing, and a filtering member for filtering foreign matter is housed inside the housing. The inside of the filter 21B communicates with the inside of the outer cylinder 20. Since the outer diameter of the filter 21B is larger than the outer diameter of the outer cylinder 20, a relatively large volume of the filtering member can be stored. Since the volume of the filtration member is large, clogging is unlikely to occur even if foreign matter accumulates on the filtration member. Further, since the filter 21B has a relatively large outer diameter, even if the ampoule formulation needle assembly 100 is placed on the work table during the work, the outer cylinder opening 23 is contaminated without touching the work table. There is no. By flattening a part of the outer peripheral surface of the filter 21B which may be flat, when the needle assembly 100 for ampoule preparation is laid on the work table, it is used for ampoule preparation. It is possible to prevent the needle assembly 100 from rolling.

6 to 9 are aspects A to D in the shape of the tip of the outer cylinder 20.

FIG. 6 is another aspect A of the outer cylinder 20. The tip of the outer cylinder 20 has an open outer cylinder opening 23, and the cylindrical outer cylinder 20 has a shape cut out by a plane having an angle inclined with respect to the central axis. The tip is blunt. By taking a non-sharp shape, the risk of damaging the surface of the ampoule 30 and the skin of the user can be reduced.

FIG. 7 is another aspect B of the outer cylinder 20. The tip is closed, and an outer cylinder opening 23 is provided on the side surface.

FIG. 8 is another aspect C of the outer cylinder 20. The tip of the outer cylinder 20 has an open outer cylinder opening 23, and the tip is provided with a plurality of tip convex portions 25 extending in the tip direction.

FIG. 9 is another aspect D of the outer cylinder 20. Similar to the aspect C, it has a plurality of tip convex portions 25, each of which is bent outward in the radial direction and extends so as to form a trumpet as a whole.

10 to 13 show that the outer cylinder 20 in aspects A to D is inserted perpendicularly to the ampoule 30 and the tip of the outer cylinder 20 is positioned on the bottom surface 34. Even when the tip of the outer cylinder 20 is in contact with the bottom surface 34 of the ampoule 30, the outer cylinder opening 23 is not blocked by the inner wall of the ampoule 30, so that stable suction can be performed.

In aspect B of FIG. 11, the outer cylinder opening 23 is located closer to the proximal end side than the cutting edge. Therefore, only the chemical solution 40 can be sucked without sucking the glass fragments and / or foreign substances deposited on the bottom surface 34 of the ampoule.

In aspect D of FIG. 13, the tip convex portion 25 is in contact with the bottom surface in an inclined state. Even if small droplets of the chemical solution 30 are attached to the bottom surface, by pushing the outer cylinder 20 toward the bottom surface, the tip convex portion 25 is deformed to bring the outer cylinder opening 23 closer to the bottom surface, leaving the chemical solution 30. Can be sucked without.

The present invention relates to an ampoule-formulating needle assembly that sucks a chemical solution from an ampoule.

1,100: Ampoule formulation Needle assembly 10: Inner needle 12: Inner needle hub 14: Needle tip 20: Outer cylinder 21: Filter 21A: Filtration member 21B: Filter 22: Outer cylinder hub 23: Outer cylinder opening 24: Umbrella 25: Convex tip 26: Tip 28: Base end face 30: Ampoule 32: Opening 34: Bottom 40: Chemical solution 50: Syringe 52: Pusher

Claims (8)

An inner needle with a needle tip and
It is provided with an outer cylinder located on the tip side of the needle tip, having a blunt tip, and at least covering the periphery of the needle tip.
The drug solution of the ampoule from the opening of the ampoule by inserting the inner needle and the outer cylinder after the suction through the outer cylinder and the inner needle, the outer cylinder is exposed to the needle tip of the inner needle It is configured to be transitionable to a state
The tip portion of the outer cylinder has a plurality of convex portions protruding with respect to the central axis direction of the outer cylinder.
A needle assembly for an ampoule formulation, characterized in that the shape of the tip of the outer cylinder is a trumpet shape. The needle assembly for an ampoule formulation according to claim 1, wherein the outer cylinder is removable from the inner needle. The outer cylinder is an ampoule preparations needle assembly according to any one of claims 1-2 capable of Ru are relatively moved in the insertion direction relative to the inner needle. The needle assembly for an ampoule formulation according to any one of claims 1 to 3 , wherein the outer cylinder has an outer cylinder hub fixed to a base end portion of the outer cylinder. The needle for ampoule formulation according to claim 4 , wherein the inner needle has an inner needle hub fixed to a base end portion of the inner needle, and the outer cylinder hub is fitted with the inner needle hub in an assembled state. Assembly. The needle assembly for an ampoule formulation according to claim 5 , wherein the outer cylinder has an umbrella portion that prevents the liquid adhering to the outer cylinder from entering the inner needle hub side. The inner space of the outer cylinder, an ampoule preparations needle assembly according to any one of claims 1 to 6 having a filter for preventing passage of glass fragments and or foreign matter the ampoule. The needle assembly for an ampoule formulation according to any one of claims 1 to 7, wherein the surface of the outer cylinder has water repellency or hydrophobicity.

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