JP3949125B2 - Multi-needle holder - Google Patents

Description

  The present invention relates to a holder with multiple needles.

  Prior to administration of an infusion solution to a patient, various drugs such as vitamins, minerals, and antibiotics are blended into the infusion solution filled in the infusion container as necessary.

  Moreover, in the field of emergency medical care, multiple combined use and large-scale administration of an autonomic nerve action drug, a pressor medicine, etc. are performed with the syringe.

  Such compounding and administration of drugs are performed by sucking a drug solution from a vial with a syringe and then injecting the drug solution into an infusion container or directly into a blood vessel. However, the compounding and administration of such a drug has a drawback in that the operation is complicated, and it takes a long time for compounding and administration. Furthermore, since the above operation is performed in contact with the atmosphere, there is a risk of bacterial contamination or contamination.

  In order to solve these problems, a so-called prefilled syringe has been proposed in which a syringe is prefilled with a chemical solution and a nozzle cap is provided with a rubber cap. However, the conventional prefilled syringe is covered with the syringe nozzle in close contact with the cap. Therefore, during high-pressure steam sterilization, steam did not enter between the nozzle and the cap, and this portion could not be sterilized. In order to solve this problem, there has been proposed one in which a gap is provided between the nozzle and the cap so that steam enters.

  By the way, as shown in FIG. 4, the prefilled syringe 1 'having the cap 3' is used with the multi-needle holder 5 attached thereto. The multi-needle holder 5 includes a cylindrical holder main body 51 and a multi-needle 52 that is fixed to the tip of the holder main body 51 and includes an inner needle 52a and an outer needle 52b. 52a is used by piercing the rubber film 32 'of the cap 3'.

  However, since the inner diameter of the holder main body 51 is almost constant over the entire length of the holder main body 51 in the conventional holder 5 with a multi-needle for prefilled syringes, the outer peripheral surface of the cap 3 ′ and the holder main body 51 are attached to the prefilled syringe 1 ′. There is a problem that a gap may be formed between the inner peripheral surface of the lens (see FIG. 4) and the stability of the mounting may be inferior.

  Accordingly, an object of the present invention is to provide a holder with a multi-needle that can be reliably fixed to an already-filled drug solution container by a simple operation and has excellent mounting stability.

Such an object is achieved by the present inventions (1) and (2) below.
(1) A holder with a multi-needle comprising a holder body and a multi-needle,
The holder main body includes a substantially cylindrical storage portion that can store a cap of a pre-filled chemical solution container, a holder female screw that fixes the multi-needle, and a holder annular protrusion formed on an inner peripheral surface of a base end portion of the storage portion. With
The multi-needle includes an inner needle and an outer needle formed by hollow needles having internal passages communicating with each other, a hub provided between these needles and formed with a male screw that is screwed into the holder female screw, A rubber tip provided so as to cover the inner needle and having resealability;
The holder annular convex portion engages with a cap annular convex portion provided on the outer peripheral surface of the cap, and when the inner needle is pierced through the rubber film of the pre-filled chemical solution container, the holder annular convex portion A holder with a multi-needle, which has a function of preventing the pre-filled chemical solution container from falling off the holder with a needle.

  (2) The holder with a multi-needle according to (1), wherein the holder main body has a reduced diameter portion whose inner diameter is reduced at a position closer to a tip side than the holder annular convex portion of the storage portion.

  According to the present invention, it is possible to attach the prefilled chemical solution container with a simple operation, and in particular, by providing the holder annular convex portion on the inner peripheral surface of the holder, the holder annular convex portion is provided with the prefilled chemical solution container. It is possible to obtain excellent mounting stability. Moreover, when the holder main body has a reduced diameter portion, the effect becomes more prominent.

  First, a configuration example of a pre-filled chemical solution container to which a holder with a multi-needle of the present invention (hereinafter simply referred to as “holder”) is mounted will be described.

  The pre-filled chemical solution container is a cap that seals the nozzle of the container body containing the chemical solution discharged by the chemical solution discharge mechanism, and has a gap through which steam can pass between the nozzle and the nozzle so that the nozzle can be sterilized It is possible to eliminate the possibility of generation of wrinkles due to cloudiness of the inner surface of the cap and moisture remaining between the cap and the nozzle, which may occur in That is, the cap has a sealing portion for liquid-tightly sealing the inside of the container body on the closed end side of the cap, and has a locking portion for locking with the nozzle in a state having a gap on the cap open end side. The space between the closed end and the open end of the cap has a space formed by the inner surface of the cap and the outer surface of the nozzle. After sterilization, water remaining between the inner surface of the cap and the outer surface of the nozzle can be easily removed. Can be transpiration. As a result, the possibility of cloudiness and wrinkles in the cap portion was eliminated.

  The chemical solution storage part is filled with chemical solutions such as vitamins, antibiotics, anticancer agents, etc. in the internal space according to the intended use. As the material for the chemical solution storage part, glass, polypropylene, polyethylene, polystyrene, synthetic resins such as various elastomers, or metals such as stainless steel and aluminum can be used, and an appropriate material should be selected according to the structure of the chemical solution discharge mechanism described later. However, it is preferable that the material is transparent so that the filled chemical solution can be visually observed. In addition, when the prefilled chemical solution container is filled with a chemical solution that is easily altered by gas or moisture such as oxygen contained in the atmosphere during sterilization or storage, select a material that is impermeable to gas and moisture impervious respectively. It is preferable to do. Examples of these include glass, metals such as stainless steel and aluminum, synthetic polyolefins such as cyclic polyolefin, polyvinyl alcohol, etc., and synthetic resins coated with silicon oxide, aluminum oxide or the gas / water impermeable resin described above, Furthermore, there is a multilayer structure in which these are used as one of layer components as required. In addition, since the prefilled chemical solution container is sterilized by moist heat, it is preferable to have heat resistance to withstand this.

  The nozzle has an internal passage through which the chemical liquid filled in the chemical liquid storage portion can be discharged to the outside, and both ends of the passage communicate with the outside and the chemical liquid storage portion, respectively. The nozzle is preferably formed of the same material integrally with the chemical solution storage unit.

  Next, the chemical solution discharge mechanism will be described. The chemical solution discharge mechanism is for discharging the filled chemical solution from the chemical solution storage part to the outside through the nozzle, and preferably has a structure for discharging by applying pressure to the chemical solution.

  Specifically, there is a configuration in which a chemical solution storage portion is formed flexibly with a synthetic resin or the like, and discharge is possible by applying an external pressure to the chemical solution storage portion to pressurize the chemical solution. Synthetic resins such as polyvinyl chloride, polypropylene, polyethylene, and various elastomers can be used as the material for forming the chemical solution storage section. When a slightly hard material is used, the chemical solution can be thinned to make it easier to press or additives. It is preferable to soften. In addition, when it is judged that the selected material for forming the chemical solution storage portion has insufficient hardness as a nozzle, the nozzle may be formed with a separate member and integrated with the drug storage portion.

  Moreover, a chemical solution discharge mechanism can also be provided to an already-filled chemical solution container by configuring the chemical solution storage portion in a so-called syringe shape. That is, the hard chemical storage part is formed into a cylindrical body that is open at one end and closed at the other end, and the open end is liquid-tightly sealed so that it can slide in the axial direction in a liquid-tight manner. And a nozzle on the other end side that is closed, so that the chemical solution in the chemical solution storage section can be discharged. It is preferable that a plunger is connected to the gasket in advance or immediately before use to facilitate the discharge of the chemical solution. In the case of being bonded in advance, the gasket and the plunger can be combined by fitting or integrally formed by integral molding. Further, when both are combined just before use, a pair of female and male screws can be provided on the gasket and plunger, or a ratchet mechanism can be employed. The material forming the cylindrical body is a material that can harden the cylindrical body, and glass, stainless steel, aluminum and other metals, and synthetic resins such as polypropylene and cyclic polyolefin are preferable. As a material for forming the gasket, natural rubber, synthetic rubber, and various elastomers can be used. Further, the plunger forming material is formed of a hard material that can withstand the operation of discharging and sucking the chemical solution, and can be appropriately selected from various hard materials such as glass, metals such as stainless steel and aluminum, and hard synthetic resins such as polypropylene and polystyrene. .

  The cap is attached to the container main body and seals the chemical liquid filled in the chemical liquid storage unit from being discharged from the nozzle until use. The cap is formed of a hollow body having a closed end (tip end) and an open end (base end opening), and the nozzle tip opening is liquid-tightly sealed on the closed end side.

  The cap body that constitutes the cap can be formed of a metal such as stainless steel or aluminum, a synthetic resin such as polyethylene or polypropylene, etc., and a portion (a rubber film described later) in contact with the tip opening of the nozzle is vulcanized natural rubber Or an elastic body such as synthetic rubber or various elastomers is preferable because it can be more reliably sealed. Also, it is made of a material such as a synthetic resin or rubber that can be pierced with a needle at least at the center of the tip of the cap, preferably a material having resealability, or a material that does not easily cause coring on the pierced hollow needle. If formed, it is also possible to administer a drug solution by directly inserting a hollow needle such as a double-ended needle into the central portion of the tip of the cap with the cap attached to the nozzle. At that time, if the central part of the cap tip surface (rubber film described later) is provided at a position drawn from the outer peripheral edge of the cap tip, the hollow needle can be inserted even if the pre-filled drug solution container is taken out of the packaging (packaging material). It is possible to prevent the passage portion from being contaminated. The pull-in is preferably 2 mm or more.

  Further, a convex portion may be formed on the inner surface of the cap closed end, and sealing may be performed between the convex portion and the inner surface of the nozzle in a state where the convex portion is fitted into the inner surface of the nozzle. In this case, the seal between them can be configured by taper fitting, or the convex portion can be an elastic body and can be brought into close contact with the inner surface of the nozzle.

  The cap further has a locking portion that locks with the nozzle at the proximal end. The locking portion has a gap for water vapor to enter between the cap and the nozzle during sterilization. As this gap, for example, a gap between screws generated by configuring the locking portion with a pair of male and female screws can be used.

  A space formed by the inner surface of the cap and the outer surface of the nozzle is provided at an intermediate portion between the closed end and the open end inside the cap. By this space part, the water vapor introduced between the nozzle and the cap for sterilization can be easily dried after sterilization. The distance between the cap inner surface and the nozzle outer surface is preferably 0.2 to 1 mm.

  In addition, it is preferable that each part forming the cap has transparency so as to facilitate confirmation of liquid leakage or the like. Moreover, it is preferable that a nozzle and a chemical | medical solution storage part also have transparency for the same reason or confirmation of the contents.

  Hereinafter, the present invention will be described in detail based on the prefilled syringe (filled drug solution container) shown in the drawings.

  FIG. 1 is a longitudinal sectional view showing a configuration example of a prefilled syringe, and FIG. 2 is a longitudinal sectional view showing a configuration example of a cap of the prefilled syringe. The prefilled syringe 1 is composed of a syringe body 2 and a cap 3. The syringe body 2 includes a cylindrical body 21 filled with a chemical solution A, a nozzle 22, a gasket 23, and a plunger 24. The cylindrical body 21 is made of cylindrical polypropylene, cyclic olefin, or the like, and has a distal end closed and a proximal end opened. A pair of flanges 21a are provided opposite to the base end. A nozzle 22 is provided integrally with the cylindrical body 21 at the closed end, and has an internal passage 22 a that can discharge the filled chemical liquid A through the nozzle 22. The nozzle 22 has a male screw 22b which forms a screwing part in a pair with the base end side of the cap 3 on the base end side outer surface. In addition, the outer surface on the front end side from the male screw 22b is a luer taper to enable connection to a three-way stopcock or the like. The gasket 23 is inserted from the proximal end opening of the tubular body 21 so as to be slidable in the axial direction while maintaining liquid tightness with the inner surface of the tubular body, and the movement of the chemical A in the proximal direction of the tubular body is restricted. is doing. The gasket 23 is formed of butyl rubber, vulcanized natural rubber, or the like, and a lubricant such as silicone is applied as necessary to improve the slidability, or a fluororesin having a low friction coefficient at the sliding portion is synthesized. A resin may be arranged. A plunger 24 made of a material such as polypropylene is fixed to the base end of the gasket 23 by screw fitting. Therefore, since it can be removed from the gasket 23 before use, the storage space can be reduced.

  The nozzle 22 is covered with a cap 3 to seal the inner passage of the nozzle, and the charged chemical A is restricted from moving toward the tip of the cylindrical body. The cap 3 includes a cap body 31 and a rubber film 32. The cap main body 31 has a through-hole 31a communicating with the inside of the cap at the center of the tip. The through-hole 31a is tapered so that an injection needle (an inner needle 42a described later) can be easily pierced. By forming the portion thick, the distance between both ends of the through-hole is increased, and the rubber film 32 described later is not contaminated even when it is opened from a packaging (wrapping material) not shown and exposed to the external atmosphere. ing. On the inner surface of the base end portion of the cap body 31, there is a female screw 31b that is paired with the male screw 22b of the nozzle 22 described above. The male screw 22b and the female screw 31b have a gap B through which gas can flow in the axial direction in a screwed state, and sterilization water vapor can enter between the cap and the nozzle, and this part can be sterilized reliably. It is configured as follows.

  The rubber film 32 is fixed inside the cap body 31 so as to cover the base end opening of the through hole 31a, and when the cap 3 is screwed and locked to the nozzle 22, the tip opening of the nozzle 22 is liquid-tightly sealed. is doing. The rubber film 32 is made of vulcanized natural rubber, synthetic rubber or various elastomers and has resealability, and the thickness is preferably 0.1 to 1 mm.

  As shown in FIG. 2, a cap annular convex portion 31 d is formed on the outer peripheral surface of the base end portion of the cap 3.

  In the cap 3, the space C is formed by separating the inner side surface (inner peripheral surface) 31 c between the tip inner surface of the cap 3 and the female screw 31 b from the outer side surface (outer peripheral surface) of the nozzle 22. is there. This space C makes it possible to easily dry the water vapor introduced between the nozzle and the cap during sterilization after sterilization.

  About this example, it experimented about the dry state after sterilization between a cap and a nozzle. A rubber film 32 made of butyl rubber having a thickness of 0.2 mm was fixed to the cap body 31, and a polypropylene cap 3 having a gap of 0.5 mm between the nozzle 22 and the inner surface of the cap was produced. This was attached to a 20 ml capacity syringe nozzle made of cyclic polyolefin filled with 20 ml of physiological saline. As a comparative example, a rubber cap closely attached to the outer surface of the nozzle instead of the cap was attached to the same physiological saline-filled syringe. For each of 25 Examples and Comparative Examples, high-pressure steam sterilization or spray sterilization at 105 ° C. was performed. With these two types of sterilization, the invasion of steam was confirmed in spray sterilization, and the dry state at the end of sterilization was confirmed in high pressure steam sterilization. The results are shown in Tables 1 and 2, respectively. The prefilled syringe according to the present invention was found to be well sterilized and dried between the cap and the nozzle.

  The prefilled syringe 1 as described above is used in combination with the holder of the present invention. That is, when the medicinal solution filled in the prefilled syringe is mixedly injected into the infusion bag or directly injected into the blood vessel of the patient, the inner needle of the hollow needle is pierced through the rubber film 32 of the cap 3, and the side opposite to the inner needle A holder 4 having an outer needle provided on is connected to the cap 3.

  FIG. 3 is a longitudinal sectional view showing an embodiment of the holder of the present invention. The holder 4 includes a holder main body 41 and a multi-needle (double-ended needle) 42.

  The holder body 41 includes a substantially cylindrical storage portion 41a that stores the cap 3 of the prefilled syringe 1, a holder female screw 41b that is positioned on the distal end side of the storage portion 41a and fixes the multi-needle 42, and a proximal end of the storage portion 41a. It has a holder annular convex part 41c formed on the inner peripheral surface of the part. Further, as shown in FIG. 3, a reduced diameter portion 41 d whose inner diameter is reduced is provided at a position closer to the tip than the holder annular convex portion 41 c of the storage portion 41 a.

  The multi-needle 42 has an inner needle 42a and an outer needle 42b made of stainless steel or synthetic resin, which are hollow needles having internal passages communicating with each other, and a hub 42c is provided between the two, and the hub 42c has the above-mentioned hub 42c. A male screw 42d that is screwed into the holder female screw 41b is formed.

  Further, a rubber chip 42e made of vulcanized natural rubber, synthetic rubber or various elastomers and having resealability is provided so as to cover the inner needle 42a. Accordingly, the inner needle 42a is not exposed even when the outer needle 42b is pierced into a mixed injection port such as an infusion bag, and the inner needle 42a is only inserted when the inner needle 42a is pierced through the rubber film 32 of the prefilled syringe 1. Therefore, a plurality of prefilled syringes can be continuously injected. Further, when the blood vessel is pierced, it is possible to prevent blood from flowing backward from the blood vessel through which the outer needle 42b is pierced.

  When the holder 4 is attached to the prefilled syringe 1, the distal end portion of the cap 3 is fitted to the reduced diameter portion 41 d and the annular annular protrusion 41 c is provided on the outer peripheral surface of the proximal end portion of the cap 3. Engages with part 31d. Thereby, when the inner needle 42a is pierced through the rubber film 32 of the prefilled syringe, it is possible to prevent the prefilled syringe from dropping from the holder 4 due to the restoring force of the rubber tip 42e.

  First, the outer needle 42b of the holder 4 in which the holder main body 41 and the multi-needle 42 are assembled is punctured into a mixed injection port such as an infusion container. Next, the cap 3 part of the prefilled syringe 1 is inserted and fitted into the storage part 41a of the holder 4, and the cap annular convex part 31d and the holder annular convex part 41c respectively provided on both are engaged, The prefilled syringe 1 is attached to the holder 4. At this time, the inner needle 42 a of the holder 4 penetrates the rubber tip 42 e and pierces the rubber film 32 of the cap 3.

  Next, the chemical solution filled by the operation of the plunger 24 of the prefilled syringe 1 is injected into the infusion container or the like from the mixed injection port. After the injection is completed, the prefilled syringe 1 is removed from the holder 4 together with the cap 3, and when a plurality of chemical liquids are injected into the same infusion container or the like, other prefilled syringes filled with the chemical liquid are similarly attached to the holder 4 in order. Then inject chemicals. Further, the rubber chip 42e during the mixed injection operation of these chemical solutions is restored to its original shape every time the prefilled syringe is extracted from the holder 4 to prevent the liquid from being scattered or contaminated by floating bacteria.

  In this example, an experiment was conducted on contamination of the rubber film 32 located on the tip side of the cap 3. The inner needle 42a of the holder 4 was pierced through the rubber film 32 of the prefilled syringe, which was prepared in the same manner as in the above experiment and attached with the cap 3 with the rubber film 32 placed at a position 2 mm from the tip surface of the cap body 31. With the inner needle 42a penetrating the rubber tip 42e and the rubber film 32, the operation of pushing the plunger 24 of the prefilled syringe and discharging the drug solution in the prefilled syringe is the same as the mixed injection operation using the conventional syringe (comparative example). Comparison was made in terms of microbial contamination. In the comparative method, microorganisms were forcibly attached to the tip of the cap of the example and the tip of the syringe nozzle of the comparative example, and a mixed injection operation was performed using a holder or an injection needle to compare the invasion of the bacteria into the drug solution. Specifically, Staphylococcus Epidermidis (ATCC strain number: No. 14990 strain) that has been preserved is streaked on TSA medium and cultured at 37 ° C. for 24 hours, and then the bacteria are made to a uniform thickness with a conage rod. I prepared what was streaked. Next, in the examples, the tip of the cap was pressed perpendicularly to the bacterial growth medium, and in the comparative example, the tip of the nozzle was pressed in the same manner, and then the above mixed injection operation was performed to measure the number of mixed bacteria in the drug solution. The results are shown in Table 3. Since the prefilled syringe according to the present invention provided a rubber film at a position 2 mm from the cap tip surface to form a sealing member, it was confirmed that there was no contamination compared to the comparative example in which the tip was exposed.

It is a longitudinal cross-sectional view which shows the structural example of the prefilled chemical | medical solution container (prefilled syringe). It is a longitudinal cross-sectional view which shows the structural example of the cap of the prefilled chemical | medical solution container. It is a longitudinal cross-sectional view which shows embodiment of the holder with a multi needle | hook of this invention. It is a longitudinal cross-sectional view which shows the state which mounted | wore the prefilled syringe with the holder with the conventional multi needle | hook.

Explanation of symbols

1 Prefilled syringe (filled chemical container)
2 Syringe body 21 Tubular body 21a Flange 22 Nozzle 22a Internal passage 22b Male screw 23 Gasket 24 Plunger 3 Cap 31 Cap body 31a Through-hole 31b Female screw 31c Inner side surface 31d Cap annular convex part 32 Rubber film A Chemical solution B Gap C Space (Space part)
4 Holder 41 Holder body 41a Storage part 41b Holder female screw 41c Holder annular convex part 41d Reduced diameter part 42 Multi needle 42a Inner needle 42b Outer needle 42c Hub 42d Male screw 42e Rubber chip 5 Conventional holder with multi needle 51 Holder body 52 Multi needle 52a Inner needle 52b Outer needle

Claims (2)

A holder with a multi-needle composed of a holder body and a multi-needle,
The holder main body includes a substantially cylindrical storage portion that can store a cap of a pre-filled chemical solution container, a holder female screw that fixes the multi-needle, and a holder annular protrusion formed on an inner peripheral surface of a base end portion of the storage portion. With
The multi-needle includes an inner needle and an outer needle formed by hollow needles having internal passages communicating with each other, a hub provided between these needles and formed with a male screw that is screwed into the holder female screw, Bei example a rubber chips having a re-sealable provided so as to cover the inner needle,
The holder annular convex portion engages with a cap annular convex portion provided on the outer peripheral surface of the cap, and when the inner needle is pierced through the rubber film of the pre-filled chemical solution container, the holder annular convex portion A holder with a multi-needle , which has a function of preventing the pre-filled chemical solution container from falling off the holder with a needle. The holder with a multi-needle according to claim 1 , wherein the holder main body has a reduced diameter portion whose inner diameter is reduced at a portion closer to a tip side than the holder annular convex portion of the storage portion.

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