1. Field of the Invention
The present invention relates to a transfer needle and, more specifically, to a transfer needle that enables safe, easy and reliable injection of liquid such as solvent or drug solution from its own container into a container with medicament contained therein, when dissolving the medicament in liquid such as solvent or drug solution and preparing drug solution for preparing fluid infusion and the like.
2. Description of the Related Art
Medicaments which are chemically unstable and may change their natures in a state of fluid infusion, such as antibiotics, anticancer agent, or blood preparation, are normally stored in a bial bottle sealed with a rubber plug in a freeze-dried state, and then those medicaments are dissolved in a solvent such as distilled water, physiological salt solution, or glucose liquid and drug solution are prepared immediately before use.
In the most general method used for such dissolving and preparing procedure in the related art, a solvent is sucked out from a container containing the solvent by using a metallic hollow needle and a syringe and injected into a container with a medicament therein, and then the medicament is dissolved in the solvent to prepare a drug solution, and the prepared drug solution is returned to the syringe. However, this method is not only complicated, but also associated with a risk of accidental puncture by the metallic hollow needle. Therefore, various types of transfer needles which can perform dissolving and preparing procedure safely, easily and reliably are proposed (For example, JP56-9464B, JP54-16152B, JP49-47507B).
However, in the transfer needle in the related art, there are problems as described below. That is, the transfer needle is generally formed by injection molding, and thus there arise the following problems. For example, as shown in
However, in this method, the length L of the portion to be positioned inside the lower hollow needle 79 plus the insertion portion 84A of the metal mold 84 (this portion is supported to the metal mold 84 only at the lower end) is significantly long, and hence there arises a problem of strength. Therefore, the metal molds 83, 84 as shown in
As described above, in the integral transfer needle in the related art, it is necessary to abut the small diameter liquid-specific hollow needle 79 and the medicament-specific hollow needle 80 against each other and mold them together. Therefore, when the metal molds 83, 84 are clamped too tight when molding, the metal molds 83, 84 may be broken. In contrast, when the metal molds 83, 84 are clamped with insufficient force, there arises such problem that flash may be generated at a portion 85 between the metal molds 83 and 84, and hence communication between the liquid-specific hollow needle 79 and the medicament-specific hollow needle 80 becomes defective. In this manner, in the related art, there was a problem in that adjustment a mold clamping force of the metal molds 83, 84 is difficult and hence molding of the transfer needle 77 cannot be performed easily.
In addition, the respective metal molds 83, 84 are formed with elongated ring-shaped holes 83B, 84B for forming hollow needles 79, 80 respectively in the vertical direction. In this case, when the diameters of the ring-shaped holes 83B, 84B are small, it is difficult to form these holes 83B, 84B, and it is further difficult to reduce the diameter of the insertion hole 83A and the insertion portion 84A, which requires a high level of technology. Therefore, when considering the molding stability of the transfer needle 77, the diameters of the ring-shaped holes 83B, 84B are obliged to be larger, and hence the diameters of the respective hollow needles 79, 80 increase correspondingly.
As shown in FIGS. 41(A) to (C), when the hollow needle 71 of the transfer needle is punctured into a rubber plug 72 of a bial bottle 70, such phenomenon that the hollow needle 71 is pressed back by a resiliency of the rubber plug 72, that is, a kick-back phenomenon occurs. However, when the diameter of the hollow needle 71 is large, a force to be pressed back when the hollow needle 71 is punctured into the rubber plug 72 increases correspondingly, whereby the possibility that communication between the hollow needle 71 and the interior of the bial bottle 70 is blocked or the hollow needle 71 comes off the rubber-plug 72 increases.
Also, as shown in FIGS. 37(A) to (C), when the metallic hollow needle 71 of the transfer needle is inserted into the rubber plug 72 of the bial bottle, the cutting edge 73, which is formed like a pointed cutting edge, is punctured into the rubber plug 72 first and inserted into the rubber plug 72 as if it tears the rubber plug 72, and then the rear portion thereof is inserted in sequence into the rubber plug 72. In this case, since the rear (end) portion of the opening edge of the cutting edge 73 of the hollow needle 71, that is, a heel portion 74 is keen, a (coring) phenomenon that rubber material of the rubber plug 72 is cut off by the heel portion 74 tends to occur, whereby there was a possibility that small chips 75 of rubber are mixed into the prepared drug solution. Coring may also occur as in the case that the diameter of the metallic hollow needle 71 is large.
Furthermore, in the related art, when the drug solution is prepared in the bial bottle by using the transfer needle, and then the prepared drug solution in the bial bottle is transferred in turn to the syringe, it was necessary to pull the hollow needle of the transfer needle off the rubber plug of the bial bottle, and then puncture the metallic hollow needle, which is connected to the syringe, again into the rubber plug to suck the prepared drug solution into the syringe. Therefore, there was a problem of generation of coring due to twice-puncture of the needle with respect to the rubber plug.
In order to solve this problem, such technology including the steps of inserting the respective hollow needles of the transfer needles into the rubber plug of the upper and lower bial bottles respectively, mixing solvent and medicament in the both bial bottles and preparing a drug solution, then when the empty upper bial bottle is brought apart from the lower bial bottle upward, bringing the distal (end) portion of the upper hollow needle or the like apart from the main body of the transfer needle, and dropping the distal (end) portion of the lower hollow needle as well in the lower bial bottle, thereby taking the prepared drug solution out from the lower bial bottle by the syringe through the main body of the transfer needle is proposed (for example, JP63-114649U). However, in this technology, since the distal ends or the like of the respective hollow needles remain in the respective bial bottles, it is troublesome to dispose the distal (end) portions of the respective hollow needles and the respective bial bottles separately, and in addition, the possibility to cause a needle-puncturing accident by the distal end portions of the respective hollow needles is high, and hence practical application was difficult.
As a result of earnest investigations made by the inventors to solve the problems associated with the conventional techniques, the present invention has been completed.
It is an object of the present invention is to provide a transfer needle that enables safe, easy and reliable dissolving medicament into liquid, such as solvent or drug solution, and preparing drug solution without causing any other problems, and that enables easy manufacturing of metal molds for the transfer needle and molding it.
The above-mentioned object and other objects of the present invention will be clarified further more in the following description, and these objects are attained by the present invention comprising the constitution mentioned below.
The present invention relates to a transfer needle comprising:
A transfer needle may comprise:
The liquid-specific member and the medicament-specific member may be connected by engaging means.
The liquid-specific hollow needle may comprise:
The communication channel may be provided with a filter.
The liquid-specific hollow needle and/or the medicament-specific hollow needle may comprise;
The liquid-specific hollow needle and/or the medicament-specific hollow needle may comprise;
The female lure may be provided with a filter.
The liquid-specific member may comprise:
The liquid-specific member and the medicament-specific member may be connected by a hinge having flexibility and being breakable.
The liquid-specific member and the medicament-specific member may be disengageably engaged,
A transfer needle may comprise:
The liquid-specific hollow needle and/or the medicament-specific hollow needle may comprise two openings at distal portions thereof.
An air channel communicating with the liquid-specific hollow needle may be formed,
The insertion body may be integrally formed via a hinge.
FIGS. 1 to 10 show a first embodiment of the present invention, and
FIGS. 11 to 13 show a second embodiment of the present invention, and
FIGS. 14 to 16 show a third embodiment of the present invention, and
FIGS. 17 to 23 show a fourth embodiment of the present invention, and
FIGS. 24 to 28 show a fifth embodiment of the present invention, and
Referring now to
The liquid-specific member 1 includes a liquid-specific hollow needle 6, a joint portion 7, a skirt 9, and a fitting portion 10, and is integrally formed of hard (or soft) plastic material.
The liquid-specific hollow needle 6 is disposed in the vertical direction and includes a column-shaped proximal portion 6A, and an upwardly tapered truncated-conical-shaped distal portion 6B. The liquid-specific hollow needle 6 is a two-hole type, and a liquid channel 12 is formed so as to penetrate into the vertical direction in a portion extending from a conical surface to a bottom surface on one side (left side in the drawing), while an air channel 13 opening at the conical surface is formed in the vertical direction on the other side (right side in the drawing) of the liquid-specific hollow needle 6. The liquid-specific member 1 is formed with a communication channel 14 in the radial direction, which is communicated with the air channel 13 of the liquid-specific hollow needle 6 at an inner end portion thereof, and opened toward the outside at an outer end portion thereof. The communication channel 14 may be provided with a filter 15 for preventing microorganism's contamination of the interior of the transfer needle T, as shown by an imaginary line in
The joint portion 7 configures means for connecting the liquid-specific member 1 and medicament-specific member 2 in a “liquid-tight state” together with a female lure 23, described later, of the medicament-specific member 2, is disposed in the vertical direction below the liquid-specific hollow needle 6 so as to be continued therefrom, is formed into a cylindrical shape communicating with the liquid channel 12 of the liquid-specific hollow needle 6, and opens downward. An outer peripheral surface of the joint portion 7 extends downward in a tapered shape.
The skirt 9 is a member fitted on a bial bottle for guiding puncture when the liquid-specific hollow needle 6 is punctured into a rubber plug of the bial bottle, is formed into a cylindrical shape, and is disposed on an upper side of an outer periphery of the liquid-specific member 1 so as to extend upright. The liquid-specific hollow needle 6 is disposed at the center of the skirt 9, and is completely enclosed and covered by the skirt 9. Accordingly, there is little risk of accidental puncture by the liquid-specific hollow needle 6.
The fitting portion 10 has a cylindrical shape disposed on a lower side of an outer periphery of the liquid-specific member 1 so as to extend downward. The joint portion 7 is disposed at the center of the fitting portion 10 so as to be covered thereby. An upper side of an inner peripheral surface of the fitting portion 10 corresponds to a threaded portion 16 formed with a thread thereon. A peripheral groove 51 is formed on an inner peripheral surface of an lower end portion of the fitting portion 10.
The medicament-specific member 2 is detachably connected to the liquid-specific member 1 from below in a liquid-tight state, and includes a base body 18, a medicament-specific hollow needle 19, and a cylindrical skirt 20 formed integrally of hard (or soft) plastic material.
An upper side of an outer peripheral surface of the base body 18 is formed with a thread, which corresponds to a threaded portion 22 to be screwed into the treaded portion 16 of the liquid-specific member 1, and an lower side of the outer peripheral surface is formed with a peripheral projection 49 to be detachably engaged with the peripheral groove 51 via resilient deformation. The peripheral groove 51 and the peripheral projection 49 are engaged by screwing the threaded portion 16 onto the threaded portion 22, while engagement between the peripheral groove 51 and the peripheral projection 49 is released and hence connection between the liquid-specific member 1 and medicament-specific member 2 is released by exerting a force to release the above-described screwing. The female lure 23 opening in the vertical direction is formed at the center of the base body 18, and the female lure 23 is a tapered hole tapering downward. The female lure 23 is a member in which the joint portion 7 is inserted and separably connected, when the medicament-specific member 2 is connected to the liquid-specific member 1, so that the tapered-shaped outer peripheral surface of the joint portion 7 is in close-contact with a tapered-shaped inner surface of the female lure 23 in a liquid-tight state. And when the liquid-specific member 1 and the medicament-specific member 2 is separated, an injection needle connecting portion of a syringe is inserted and separably connected in the female lure 23, so that a tapered-shaped outer peripheral surface of the injection needle connecting portion is in close-contact with the tapered-shaped inner surface of the female lure 23 in a liquid-tight state. There may be the case in which a filter 24 for preventing residual of medicament, which could not melt, from passing through and removing foreign substance is provided at the bottom in the female lure 23.
The medicament-specific hollow needle 19 is disposed in the vertical direction so as to extend downward from a center portion of the base body 18. The medicament-specific hollow needle 19 includes a proximal portion 19A formed into a cylindrical shape and communicating with the female lure 23, and a distal portion 19B formed into a hollow conical shape having a pointed tip facing downward, and the interiors of the proximal portion 19A and the distal portion 19B are communicating with each other. The inner diameter of the proximal portion 19A is smaller than the inner diameter of the female lure 23. The medicament-specific hollow needle 19 is so-called “rocket needle” type having four openings 19C formed at the distal portion 19B at regular intervals in the circumferential direction in the drawing. However, the number of openings 19C is arbitrary. It is also possible to employ the medicament-specific hollow needle 19 of so-called “side hole needle” type having openings at a distal end portion of the proximal portion 19A.
The skirt 20 is provided on a lower end portion of the outer peripheral surface of the base body 18 so as to extend downward, and is configured to be fitted on the medicament-specific hollow needle 19 for guiding the same. The medicament-specific hollow needle 19 is disposed at the center of the skirt 20, and is completely enclosed and covered by the skirt 20. Accordingly, there is little risk of accidental puncture by the medicament-specific hollow needle 19 owing to the existence of the skirt 20.
Subsequently, a dissolving procedure of the medicament into liquid such as solvent or drug solution and a preparing procedure of drug solution by using the transfer needle T of the present invention and suction of the prepared drug solution into a syringe made via this preparation procedure will be described referring to
Subsequently, as shown in
Subsequently, as shown in
Subsequently, as shown in
According to the embodiment described above, since the female lure 23 which communicates with the medicament-specific hollow needle 19 of the medicament-specific member 2 and receives the injection needle connecting portion 34 of the syringe 33 so as to be separably connected thereto in a liquid-tight state is provided at an portion of the medicament-specific member 2 facing the liquid-specific member 1, it is not necessary to pull out the medicament-specific hollow needle 19 from the rubber plug 28A of the bial bottle 28 and then puncture the metallic hollow needle connected to the syringe again into the rubber plug 28A when moving the prepared drug solution 30 in the bial bottle 28 into the syringe 33 after having prepared the drug solution 30 in the bial bottle 28 by using the transfer needle T. Therefore, there is no risk of generation of coring which may be resulted when the needle is punctured into the rubber plug 28A twice.
In addition, there is no possibility that the distal end portions or the like of the respective hollow needles 6, 19 remain in the bial bottle 28 during the dissolving and preparing procedure described above, and hence it is not necessary to dispose the distal end portions or the like of the respective hollow needles 6, 19 and the bial bottle 28 separately, and furthermore, the possibility of accidental puncture by the distal end portions or the like of the hollow needles 6, 19 is reduced.
As described above, according to the embodiment described above, the dissolving procedure of the medicament into solvent or drug solution and the preparing procedure of drug solution can be performed easily and reliably, the dissolving and preparing procedure can be performed safely and hygienically since the risk of accidental puncture is reduced, and the phenomenon that the rubber material is cut off the rubber plug 28A (coring) hardly occurs when the respective hollow needles 6, 19 are punctured into the rubber plug 28A, whereby the possibility that the small chips of the rubber are mixed into the prepared drug solution is reduced. Generation of coring which may be resulted when the needle is punctured into the rubber plug 28A twice is also prevented.
According to the embodiment described above, when sucking the prepared drug solution 30 into the syringe 33 after separating the liquid-specific member 1 and the medicament-specific member 2, engagement between the engaging ring 45 and the engaging strip 46 is released, then an external force, which acts to tear the hinge 44, is exerted to the hinge 44 to break the same, and then the liquid-specific member 1 and the medicament-specific member 2 are separated. Subsequently, the injection needle connecting portion 34 of the syringe 33 is connected to the female lure 23 of the medicament-specific member 2, so that the tapered-shaped outer peripheral surface of the injection needle connecting portion 34 is in close-contact with the tapered-shaped inner surface of the female lure 23 in a liquid-tight state.
Subsequently, a method of molding the transfer needle will be described by taking the liquid-specific member 1 of the fourth embodiment as an example. However, the medicament-specific member 2 of a fourth embodiment, or the liquid-specific member 1 or the medicament-specific member 2 for other embodiments may be molded in the same manner. The liquid-specific member 1 of the forth embodiment is molded as shown in
In the present invention, since the transfer needle T is a separate type including the liquid-specific member 1 having the liquid-specific hollow needle 6 and the medicament-specific member 2 having the medicament-specific hollow needle 19, the lower end of the insertion portion 54A for molding the liquid-specific hollow needle 6 is directly supported by the lower metal mold 54, and the length from an upper (distal) end of the insertion portion 54A to the supporting portion, which supports the insertion portion 54A, of the lower metal mold 54 is short. Therefore, there exists no problem about the strength of the insertion portion 54A. Accordingly, since the liquid-specific hollow needle 6 can be molded by the metal molds 53, 54, the small-diameter liquid-specific hollow needle 6 can be molded easily (it is the same in the case of the medicament-specific hollow needle 19).
Therefore, when the hollow needles 6, 19 of the transfer needle T is punctured into the rubber plug of the bial bottle, a phenomenon that the hollow needles 6, 19 are pressed back by a resiliency of the rubber plug, that is, the kick-back phenomenon can be prevented, and the force that the hollow needles 6, 19 are pressed back from the rubber plug may be reduced, whereby the risk of blockage of communication between the respective hollow needles 6, 19 and the interior of the bial bottle or accidental disconnection of the respective hollow needles 6, 19 from the rubber plug can be reduced, whereby coring can be prevented.
In the integral transfer needle in the related art, it is necessary to abut a liquid-specific hollow needle and a medicament-specific hollow needle against each other and mold them together, adjustment of the clamping of an upper and a lower metal molds is troublesome, and hence molding of the transfer needle cannot be performed easily. Therefore, there was a risk of breakage of the upper and lower metal molds or generation of flash during molding, which may result in defect of communication between the liquid-specific hollow needle and the medicament-specific hollow needle. However, such risk may be avoided in the present invention.
According to the embodiment described above, since the liquid-specific hollow needle 6 and the medicament-specific hollow needle 19 include the openings 6C, 19C at the distal (end) portions of the proximal portions 6A, 19A, that is, of so-called “side hole needle” type, when the medicament-specific hollow needle 19 is punctured into the rubber plug of the bial bottle, occurrence of coring may be prevented. Also, when the liquid in the bial bottle is flown into the bial bottle containing the medicament therein via the liquid-specific hollow needle 6, the joint portion 7, the female lure 23, and the medicament-specific hollow needle 19 of the transfer needle T during dissolving the medicament in liquid such as solvent or drug solution and preparing drug solution, the liquid is injected from the opening 19C of the medicament-specific hollow needle 19 of the “side hole needle” type, runs along the wall surface of the bial bottle containing the medicament, and reaches the medicament. Therefore, bubbling during the dissolving and preparing procedure may be alleviated.
Number | Date | Country | Kind |
---|---|---|---|
2003-275735 | Jul 2003 | JP | national |