Syringe device and method of preparing medicine using the device

#The present invention relates to a syringe device, in which a solution is mixed with a soluble pharmaceutical drug, to be used in a dissolved state before use, and a method of preparing liquids and solutions using the device. More particularly, the present invention relates to a syringe device, in which a solid lyophilized product or a powdery agent is principally used as a soluble pharmaceutical drug, and a method of preparing liquids and solutions using the device.

#Conventionally, a lyophilized product, for example, is dissolved before use, and then, is given to a person. However, some lyophilized products are unstable since they are liable to be dissolved in water, oxygen or the like, or have bubbles which are hardly dissipated during dissolution. The lyophilized products such as an antibiotic, a growth hormone or a vaccine are stably stored or generally stored in a vial under a reduced pressure lower than an atmospheric pressure in order to prevent any generation of bubbles during the dissolution. However, in the case where the lyophilized product is stored in the vial, a dissolved liquid medicine need be transferred into a syringe, and therefore, it cannot be used at once. Otherwise, in the case where the liquid medicine obtained by dissolving the lyophilized product has a high viscosity, the syringe hardly sucks up the liquid medicine.

#To deal with the above mentioned problem, as shown in FIG. 18 (see Patent Document 1), the inventors of the present application have developed a pressure reducing syringe 102 capable of storing a lyophilized product M therein under a reduced pressure by utilizing a sealed rubber plug 100 with a flange and a piston (i.e., a gasket) 101 having an air-liquid relief groove. In using the pressure reducing syringe 102 shown in FIG. 18, an outside syringe 105 having a syringe needle 103 attached thereto is prepared independently of the pressure reducing syringe 102. In this state, the syringe needle 103 of the outside syringe 105 pierces a rubber plug 108 of a vial 107 containing an attached solvent L therein. And then, a tip rubber packing 112 fixed to the pressure reducing syringe 102 is unsealed by one end (i.e., an upper end) of the syringe needle 103 by inserting the pressure reducing syringe 102 into the outside syringe 105, as indicated by an arrow. Subsequently, the sealed rubber plug 100 of the pressure reducing syringe 102 is detached, and further, a push rod 111 is connected to the piston 101, as shown in FIG. 19. Finally, the attached solvent L is sucked up into the pressure reducing syringe 102, to be dissolved inside of the syringe 102.

#FIG. 1 is a vertically cross-sectional view showing a first syringe in a syringe device, to which the invention is applied.

#FIG. 2 is a vertically cross-sectional view showing a second syringe in the syringe device, to which the invention is applied.

#FIG. 3 is a vertically cross-sectional view showing a connection holder in the syringe device, to which the invention is applied.

#FIGS. 1 to 17 show an embodiment according to the present invention. A syringe device according to the present invention, as shown in FIG. 10, comprises: a cylindrical connection holder 6 partitioned into a first cylindrical part 11 on a lower side and a second cylindrical part 12 on an upper side via a partition wall 31; a double ended needle assembly 10 and a cylindrical and bottomed intermediate holder 3 which are fitted into the first cylindrical part 11; a first syringe 1 which contains an attached solvent L in a predetermined quantity therein and is inserted into the intermediate holder 3; a second syringe 2 which contains therein a lyophilized product M under a reduced pressure and is inserted into the second cylindrical part 12; and push rods 15 and 16 inserted into the syringes 1 and 2, respectively. In the embodiment, each of the syringes 1 and 2, the intermediate holder 3, the connection holder 6 and the push rods 15 and 16 is made of a transparent glass material, but may be made of plastic or other opaque materials. Although in the above description, the side of the second cylindrical part 12 and the side of the first cylindrical part 11 in the connection holder 6 are referred to as “the upper side” and “the lower side”, respectively, they are defined merely for the sake of explanation, and therefore, the embodiment is not limited to the vertical relationship.

#FIG. 1 is a vertically cross-sectional view showing the first syringe 1 for the solution. The first syringe 1 is formed into a bottomed cylindrical shape and is sealed by an unsealable rubber packing 18 at an upper bottom thereof. The rubber packing 18 is secured via a plastic cap 19 fitted at the upper end of the first syringe 1. A center hole 19a for inserting a needle therethrough is formed in the cap 19. The attached solvent L is contained in a predetermined quantity inside of the first syringe 1. A lower surface of the first syringe 1 containing the attached solvent L therein is sealed by a rubber piston (i.e., a gasket) 20 which is slidably fitted into the first syringe 1. A tip (i.e., an upper end) of the push rod 15 is screwed to the piston 20. A stopper fitting hole 21 which greatly extends in a longitudinal direction of the rod 15 is formed in the push rod 15. A stopper 22 is fitted into the stopper fitting hole 21 in a withdrawable manner at an arbitrary position in the longitudinal direction of the rod 15. When the stopper 22 is fitted to a lower edge of the first syringe 1, the push rod 15 can be prevented from being pushed into the first syringe 1 from a desired position.

#FIG. 8 is an enlarged view showing the push rod 15. Numerous locking projections 21a are formed at the inner circumferential surface of the stopper fitting hole 21 at equal intervals in a vertical direction. As shown in a cross-sectional view, FIG. 9, a plurality of recesses 22b to be fitted to the projections 21a, respectively, are formed at the stopper 22. The engagement of the projection 21a with the recess 22b inhibits any movement in the longitudinal direction of the rod. Furthermore, a flange 22a is formed at an end of the stopper 22. The stopper 22 has the function of preventing any leakage of the attached solvent L if the push rod 15 is pushed into the first syringe 1 at the time of, principally, shipment, carriage and transportation. Incidentally, the push rod 16 on the upper side in FIG. 10 also is constituted in the same manner as the push rod 15 on the lower side except that the push rod 16 does not particularly include any stopper like the stopper 22 of the push rod 15.