Syringe device and method of preparing medicine using the device

A syringe device and a method of preparing medicine using the device capable of easily and accurately performing operations for mixing and dissolving a lyophilized product into a dissolution liquid before use. A double ended needle assembly and an intermediate holder are fitted to the first cylindrical part of a connection holder, a first syringe in which the dissolution liquid is stored is inserted into the first cylindrical part through the intermediate holder, and a second syringe in which the lyophilized product is stored in a depressurized state is fixedly inserted into the second cylindrical part of the connection holder. First, the intermediate holder is locked by a finger hooking projected piece, the first syringe is pushed into the intermediate holder in the locked state of the double ended needle assembly at an initial position by locking ribs, and the first syringe is unsealed by one end of the double ended needle. Next, the intermediate holder and the double ended needle assembly are pushed into the first cylindrical part by the first syringe, and the second syringe in the second cylindrical part is unsealed by the other end of the double ended needle.

TECHNICAL FIELD

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.

BACKGROUND ART

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 inFIG. 18(see Patent Document 1), the inventors of the present application have developed a pressure reducing syringe102capable of storing a lyophilized product M therein under a reduced pressure by utilizing a sealed rubber plug100with a flange and a piston (i.e., a gasket)101having an air-liquid relief groove. In using the pressure reducing syringe102shown inFIG. 18, an outside syringe105having a syringe needle103attached thereto is prepared independently of the pressure reducing syringe102. In this state, the syringe needle103of the outside syringe105pierces a rubber plug108of a vial107containing an attached solvent L therein. And then, a tip rubber packing112fixed to the pressure reducing syringe102is unsealed by one end (i.e., an upper end) of the syringe needle103by inserting the pressure reducing syringe102into the outside syringe105, as indicated by an arrow. Subsequently, the sealed rubber plug100of the pressure reducing syringe102is detached, and further, a push rod111is connected to the piston101, as shown inFIG. 19. Finally, the attached solvent L is sucked up into the pressure reducing syringe102, to be dissolved inside of the syringe102.

DISCLOSURE OF THE INVENTION

Problems to be Solved by the Invention

However, in the case where the attached solvent L contained inside of the vial107is sucked up as shown inFIG. 19, the syringe needle103of the outside syringe105need pierce in the state in which the vial107is fixed by any means, and further, the attached solvent L need be sucked up by a predetermined quantity while visually measuring a suction quantity. This takes much labor and time in mixture and dissolution before use, and therefore, experience and skill are required to operate with speed and accuracy.

Object of the Invention

An object of the present invention is to provide a syringe device, in which a predetermined quantity of solution can be readily mixed with and dissolved in a predetermined quantity of soluble pharmaceutical drug such as a lyophilized product with accuracy in a good state without either experience or skill before use.

Means for Solving the Problems

In order to solve the above-described problems, a syringe device according to claim1of the present invention comprises: a cylindrical connection holder6which is partitioned into a first cylindrical part11and a second cylindrical part12via a partition wall31having a through hole30formed thereat; a cylindrical and bottomed intermediate holder3having a needle inserting hole46formed at a tip of a bottom thereof; a first cylindrical and bottomed syringe1which contains a solution therein and is unsealably sealed at a tip of a bottom thereof; a second cylindrical and bottomed syringe2which contains a soluble pharmaceutical drug therein and is unsealably sealed at a tip of a bottom thereof, and a double ended needle assembly10; the double ended needle assembly10and the intermediate holder3being inserted in this order into the first cylindrical part11, the first syringe1being inserted into the intermediate holder3, and the second syringe2being inserted into the second cylindrical part12; wherein the double ended needle assembly10is locked at an initial position, at which a needle sharp tip55aon a side of the partition wall31cannot project inward of the second cylindrical part12by a locking portion, and further, can be moved against a frictional resistance of the locking portion from the initial position to a second position, at which the needle sharp tip55apasses through the through hole30so as to unseal the tip of the bottom of the second syringe2; and the intermediate holder3is locked at a standby position, at which it cannot act on the double ended needle assembly10at the initial position, by locking means, and further, the double ended needle assembly10can be movably pushed to the second position by unlocking the lock by unlocking means.

According to claim2of the present invention, in the syringe device according to claim1, a projected piece51for locking the intermediate holder3at the standby position in abutment against an edge in a longitudinal direction of the first cylindrical part11as the locking means is disposed in the intermediate holder3, and further, a guide groove34serving as the unlocking means, which movably guides the intermediate holder3from the standby position toward the partition wall by the fitting of the projected piece51owing to the turn of the intermediate holder3, is formed at the first cylindrical part11.

According to claim3of the present invention, a method of preparing liquids and solutions by using the syringe device according to claim1or claim2of the present invention comprises the steps of: inserting and pushing a push rod15into a first syringe1, so as to unseal a tip of a bottom of the first syringe1with one needle sharp tip55bof a double ended needle assembly10; pushing an intermediate holder3inside of a first cylindrical part11toward a partition wall31, so as to unseal a tip of a bottom of a second syringe2with the other needle sharp tip55aof the double ended needle assembly10; and alternately pushing the push rod15and another push rod16inserted into the syringes1and2, respectively, in the state in which both of the syringes1and2communicate with each other via the double ended needle assembly10, so as to mix and dissolve a solution with and in a pharmaceutical drug, thus producing the liquids and solutions.

Eefects of the Invention

(1) The predetermined positional interrelationship among the first syringe containing the solution therein, the second syringe containing the soluble pharmaceutical drug such as a solid lyophilized product or a powdery agent therein, and the double ended needle assembly for allowing the first and second syringes to communicate with each other is held by the single connecting holder. In this held state, the solution is mixed with and dissolved in the pharmaceutical drug. Thus, the solution can be readily mixed with and dissolved in the pharmaceutical drug while the predetermined positional interrelationship among both of the syringes and the double ended needle assembly can be stably held even by an inexperienced person, unlike the prior art shown inFIGS. 18 and 19, in which the outside syringe pierces the vial, and then, the pressure reducing syringe is inserted into the outside syringe, followed by mixing and dissolving.

(2) The solution and the lyophilized product or the like in the predetermined quantity can be mixed with each other while being contained inside of the syringes, respectively. Thus, the liquid medicine can be accurately produced in a desired concentration and quantity, unlike the prior art shown inFIGS. 18 and 19, in which the predetermined quantity of solution is sucked up from the vial based on the visual measurement. In addition, the mixed and dissolved liquid medicine is contained inside of, for example, the first syringe, so that the first syringe and the intermediate holder as they are can be utilized in giving the liquid medicine to a person, thus improving operational efficiency.

(3) The mixture and the dissolution can be performed in the state in which both of the syringes and the double ended needle assembly are contained inside of the connecting holder, thus enhancing operational safety and improving sanitation without any spattering of the liquid medicine outside even if the liquid medicine leaks during the operation.

(4) The operation in the first step, in which there are provided the locking portion for locking the double ended needle assembly inside of the first cylindrical part at the initial position, at which nothing acts on the second syringe, the locking means for locking the intermediate holder inside of the first cylindrical part at the standby position, at which nothing acts on the double ended needle assembly at the initial position, and the unlocking means for the locking means, thus pushing the first syringe into the locked intermediate holder, so as to unseal the first syringe; and the operation in the second step, in which the locking means is unlocked, so that the double ended needle assembly is pushed from the initial position to the second position together with the first syringe and the intermediate holder, so as to unseal the second syringe, thus allowing both of the syringes to communicate with each other, are necessarily performed in this order. Thus, the mixing and dissolving operations can be performed without any mistake of the operational order even by an inexperienced person. Specifically, in the operation in the first step, the first syringe on the side of the solution is unsealed by piercing the first syringe with the needle sharp tip of the double ended needle assembly, so that the first syringe is deaerated. Thereafter, both of the syringes communicate with each other by piercing the second syringe with the needle sharp tip of the double ended needle assembly, followed by mixing and dissolving. Thus, it is possible to prevent any generation of bubbles in the lyophilized product, so as to smoothly dissolve the lyophilized product.

(5) The flange as the locking means is formed at the intermediate holder, and further, the guide groove as the unlocking means is formed at the connecting holder. Thus, the fabrication is easy, and further, the unlocking operation also is easy since the lock can be unlocked only by rotating the intermediate holder.

(6) Since a rib as the locking portion for locking the double ended needle assembly at the initial position is formed at the inner circumferential surface of the first cylindrical portion, the fabrication is easy.

BEST MODE FOR CARRYING OUT THE INVENTION

FIGS. 1 to 17show an embodiment according to the present invention. A syringe device according to the present invention, as shown inFIG. 10, comprises: a cylindrical connection holder6partitioned into a first cylindrical part11on a lower side and a second cylindrical part12on an upper side via a partition wall31; a double ended needle assembly10and a cylindrical and bottomed intermediate holder3which are fitted into the first cylindrical part11; a first syringe1which contains an attached solvent L in a predetermined quantity therein and is inserted into the intermediate holder3; a second syringe2which contains therein a lyophilized product M under a reduced pressure and is inserted into the second cylindrical part12; and push rods15and16inserted into the syringes1and2, respectively. In the embodiment, each of the syringes1and2, the intermediate holder3, the connection holder6and the push rods15and16is 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 part12and the side of the first cylindrical part11in the connection holder6are 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. 1is a vertically cross-sectional view showing the first syringe1for the solution. The first syringe1is formed into a bottomed cylindrical shape and is sealed by an unsealable rubber packing18at an upper bottom thereof. The rubber packing18is secured via a plastic cap19fitted at the upper end of the first syringe1. A center hole19afor inserting a needle therethrough is formed in the cap19. The attached solvent L is contained in a predetermined quantity inside of the first syringe1. A lower surface of the first syringe1containing the attached solvent L therein is sealed by a rubber piston (i.e., a gasket)20which is slidably fitted into the first syringe1. A tip (i.e., an upper end) of the push rod15is screwed to the piston20. A stopper fitting hole21which greatly extends in a longitudinal direction of the rod15is formed in the push rod15. A stopper22is fitted into the stopper fitting hole21in a withdrawable manner at an arbitrary position in the longitudinal direction of the rod15. When the stopper22is fitted to a lower edge of the first syringe1, the push rod15can be prevented from being pushed into the first syringe1from a desired position.

FIG. 8is an enlarged view showing the push rod15. Numerous locking projections21aare formed at the inner circumferential surface of the stopper fitting hole21at equal intervals in a vertical direction. As shown in a cross-sectional view,FIG. 9, a plurality of recesses22bto be fitted to the projections21a,respectively, are formed at the stopper22. The engagement of the projection21awith the recess22binhibits any movement in the longitudinal direction of the rod. Furthermore, a flange22ais formed at an end of the stopper22. The stopper22has the function of preventing any leakage of the attached solvent L if the push rod15is pushed into the first syringe1at the time of, principally, shipment, carriage and transportation. Incidentally, the push rod16on the upper side inFIG. 10also is constituted in the same manner as the push rod15on the lower side except that the push rod16does not particularly include any stopper like the stopper22of the push rod15.

FIG. 2is a vertically cross-sectional view showing the second syringe2for the lyophilized product at the time of the shipment. The second syringe2is formed into a bottomed cylindrical shape. A lower bottom of the second syringe2is sealed by an unsealable rubber packing23, which is secured via a plastic cap24fitted at the lower end of the second syringe2. A center hole24afor inserting a needle therethrough is formed at the cap24. Here, component parts for the second syringe2, the rubber packing23and the cap24are identical to those for the first syringe1, the rubber packing18and the cap19shown inFIG. 1, respectively. With reference toFIG. 2again, the lyophilized product M is contained under a reduced pressure inside of the second syringe2. A rubber piston25is slidably fitted at an upper inner surface of the second syringe2containing the lyophilized product M therein. A female screw25afor connecting the push rod is formed on the piston25. A sealed rubber plug26is fitted in upper opening of the second syringe2and includes a large-diameter body26afor maintaining an air-tight state in press-contact with the inner circumferential surface of the second syringe2, a flange26bto be locked at an upper edge of the second syringe2, and a small-diameter projection26cprojecting downward from the body26a.The projection26cis set in a dimension enough to be slightly press-fitted to the female screw25aat the piston25, and therefore, cannot fall during production of the lyophilized product. Furthermore, a cylindrical half hammering plug jig27for use in a sealing process under a reduced pressure around the second syringe2at the upper end thereof remains in a fitted state.

FIG. 3is a vertically cross-sectional view showing the connection holder6. A partition wall31is formed at the middle in a longitudinal direction and has a communication hole30. The connection holder6is partitioned into the large-diameter first cylindrical part11for fitting the intermediate holder disposed under and the small-diameter second cylindrical part12for fitting the second syringe disposed above on the boundary of the partition wall31.

A guide groove34serving as unlocking means in a predetermined vertical length (i.e., a depth) S1is formed at the lower end of the first cylindrical part11. Moreover, a slit-like sub guide groove35extending upward more by a predetermined length S2is formed at the upper end of the guide groove34.

A plurality of locking ribs40and a plurality of locking ribs41are formed on the inner circumferential surface of the connection holder6. The locking ribs40serve as locking portions for the double ended needle assembly and extend downward by a predetermined length S3from a lower surface of the partition wall31. The locking ribs41serve as locking portions for the second syringe and extend upward by a predetermined length S4from an upper surface of the partition wall31. The locking ribs40and41are formed at equal intervals in the number of four each in the circumferential direction.

FIG. 4is a cross-sectional view taken along a line IV-IV ofFIG. 3. The guide grooves34formed at the lower end of the first cylindrical part11are paired at an interval of 180° in the circumferential direction. A pair of finger gripping flanges43are formed outward at an interval of 180° in the circumferential direction at the upper end of the second cylindrical part12.

FIG. 5is a vertically cross-sectional view showing the intermediate holder3. An inner cylindrical portion44for inserting a needle therethrough and an outer cylindrical portion45for fitting a needle thereto are formed on an upper bottom3aof the intermediate holder3and they project upward. A needle inserting hole46penetrating in a vertical direction is formed at the inner cylindrical portion44. In the meantime, a spiral groove47for holding a needle therein at the inner circumferential surface of the outer cylindrical portion45. A plurality of locking ribs50for the first syringe are formed on the inner circumferential surface of the intermediate holder3and extend downward from the upper bottom3aby a predetermined length S5. A pair of finger hooking projected pieces51extending outward in a radial direction are integrally formed on the lower end of the intermediate holder3. Moreover, a pair of ribs52extending upward from the finger hooking projected pieces51by a predetermined length S6at the outer peripheral surface of the intermediate holder3.

FIG. 6is a bottom view ofFIG. 5. The locking ribs50formed at the inner circumferential surface of the intermediate holder3are arranged at equal intervals in the number of four in the circumferential direction. The finger hooking projected piece51and the ribs52each are paired at an interval of 180° in the circumferential direction. Here, a circumferential width of the finger hooking projected51is set to a dimension enough to be fitted into the guide groove34at the connection holder6(indicated by a virtual line). In the meantime, the rib52is set to a dimension enough to be fitted into the sub guide groove35shown inFIG. 3.

FIG. 7is a vertically cross-sectional view showing the double ended needle assembly10. The double ended needle assembly10is constituted of a plastic needle holder56formed into a bottomed cylindrical shape and a double ended needle55securely fixed to the center of the needle holder56. Sharp ends55aand55bacutely cut off are formed at openings at both of upper and lower ends of the double ended needle55. A needle projecting length H1upward from the needle holder56and a needle projecting length H2downward from the needle holder56need be set enough to penetrate the rubber packings23and18shown inFIG. 10, respectively, but not to interfere with the pistons25and20, respectively. The description will be made later in greater detail under the section of an assembled state.

[Assembled State of Syringe Device Immediately Before Use]

FIG. 10shows an assembled state of the syringe device immediately before use. Before use, the intermediate holder3, the double ended needle assembly10and the first syringe1are incorporated in the connection holder6: in contrast, the second syringe2for the lyophilized product is provided while including the sealed rubber plug26and the half hammering plug jig27, as shown inFIG. 2. The sealed rubber plug26is detached from the second syringe2immediately before use, and then, the second syringe2is inserted into the second cylindrical part12of the connection holder6, as shown inFIG. 10.

The second syringe2inserted into the second cylindrical part12is stably secured inside of the second cylindrical part12at a final insertion stroke (S4) by pushing the cap24to the partition wall31against the frictional resistance of the locking rib41. In the meantime, the double ended needle assembly10and the intermediate holder3are inserted into the first cylindrical part11in this order, wherein the first syringe1containing the attached solvent L therein is inserted into the intermediate holder3. The push rods15and16are screwed, respectively, in the respective pistons20and25inside of the first and second syringes1and2. In this stage, even if the stopper22for the push rod15is detached, the following operation can be substantially implemented enough to be smoothly performed. However, the stopper22remains disposed in order to securely prevent any leakage of the attached solvent L by an accidental operation.

The double ended needle assembly10is stopped at an initial position apart by the predetermined distance (i.e., the length of the rib) S3from the partition wall31since the upper end of the needle holder56is locked by the locking ribs40inside of the first cylindrical part11. The upward projecting length H1of the double ended needle55is set to be smaller than the length S3of the locking ribs40. As a consequence, the upper sharp tip55aof the double ended needle55does not project inward of the second syringe2at the initial position of the double ended needle assembly10, and therefore, does not pierce the rubber packing23of the second syringe2. Incidentally, in the present embodiment, the upper sharp tip55ais located under the partition wall31.

The intermediate holder3is inserted to the standby position, at which the finger hooking projected piece51at the lower end abuts against the lower edge of the first cylindrical part11. At this standby position, the downward projecting portion of the double ended needle55is inserted into the needle inserting hole46of the intermediate holder3, so that the upper end of the inner cylindrical portion44is brought into slight contact with the lower surface of the needle holder56or comes very close to the lower surface of the needle holder56.

The first syringe1inserted into the intermediate holder3is stopped at a position apart by the distance S5from the upper bottom3aof the intermediate holder3since the upper cap19is locked in the locking rib50at the upper end inside of the intermediate holder3. Thus, the lower sharp tip55bof the double ended needle55does not pierce the rubber cap18in the first syringe1.

[Production of Lyophilized Product and Sealing Method under Reduced Pressure]

Next, before explanation is made on operation for mixing and dissolving the lyophilized product, a description will be simply given of the structure of the half hammering plug jig27(seeFIG. 2) and a method for producing the lyophilized product M inside of the second syringe2and sealing it under a reduced pressure in reference toFIGS. 16 and 17.

FIG. 17is a vertically cross-sectional view showing the half hammering plug jig27in enlargement. A flange and an annular step27afor allowing the sealed rubber plug to be seated thereon are formed at the upper end of the half hammering plug jig27. An air-liquid relieving groove27bfor use in a pressure reducing process is formed at a lower half portion of the half hammering plug jig27. Furthermore, an inward locking projection27cfor locking the half hammering plug jig27at a position of a half hammering plug is formed at the inner circumferential surface.

FIG. 16shows the process for producing the lyophilized product. The second syringe2having the rubber packing23and the cap24disposed thereat is upright held on a cylindrical support mount29. A liquid medicine M′ before being frozen and dried is contained inside of the second syringe2in the held state, the half hammering plug jig27is fitted around the upper end of the second syringe2, and then, the inward locking projection27cis locked at the upper edge of the second syringe2, which is thus stopped at the position of the half hammering plug. The female screw25aof the piston25is fitted to the projection26cof the sealed rubber plug26, and thereafter, the sealed rubber plug26is inserted into the half hammering plug jig27from above. As a consequence, the flange26bof the sealed rubber plug26is seated at the annular step27aof the half hammering plug jig27.

The second syringe2in the half hammering plug state, as shown inFIG. 16, is put into a freeze-drier, thereby freezing the liquid medicine M′, followed by removing moisture or the like under a reduced pressure inside of the freeze-drier. The removed moisture is relieved to the outside through the air-liquid relieving groove27bformed at the half hammering plug jig27. After the relief of the moisture or the like, the sealed rubber plug26together with the half hammering plug jig27is pushed down to a fully hammering plug position, at which the flange26bis locked at the upper edge of the second syringe2, to be thus sealed under the reduced pressure.

[Operation for Mixing Attached Solvent and Dissolving]

(1) Operation in First Stage

InFIG. 10, the connection holder6is held by one hand of an operator while the push rod15on the side of the first syringe1is pushed by the other hand of the operator. For example, the index and middle fingers of one hand hook on the finger hooking projected pieces51of the intermediate holder3, and further, a thumb pushes the push rod15. Consequently, the first syringe1is moved upward with respect to the intermediate holder3via the stopper22together with the push rod15against the frictional resistance of the locking rib50, and thereafter, the cap19comes to a halt in abutment against the upper bottom3aof the intermediate holder3at a timing when the first syringe1is moved upward by the distance S5, as shown inFIG. 11. The first syringe1is moved by the distance S5with respect to the intermediate holder3, so that the lower sharp tip55bof the double ended needle55pierces the rubber cap18in the first syringe1, thereby unsealing the first syringe1. In this manner, the first syringe1is deaerated by unsealing the first syringe1in the operation in the first stage. Since the double ended needle assembly10is held at the initial position by the locking ribs40inside of the first cylindrical part11during the operation in the first stage, the double ended needle assembly10cannot be moved upward, and further, the intermediate holder3cannot be moved upward since the finger hooking projected piece51is locked to the lower edge of the first chamber11, so that the second syringe2cannot be unsealed. Additionally, the rib52formed at the outer peripheral surface of the intermediate holder3is brought into press-contact with the inner circumferential surface of the first cylindrical part11, and therefore, the intermediate holder3can be stably held in the first cylindrical part11without any play in a radial direction.

(2) Operation in Second Stage

After the first syringe1is unsealed, as described above, the intermediate holder3is rotated at an angle of 90° thereon, as indicated by an arrow R inFIG. 6, from the state shown inFIG. 11, so that the finger hooking projected piece51mates with the guide groove34, in an operation in a second stage. Specifically, the intermediate holder3is unlocked at the standby position, and thus, the finger hooking projected piece51can be moved upward inside of the guide groove34. Thereafter, the intermediate holder3is pushed upward from the standby position shown inFIG. 11, so that the double ended needle assembly10is moved by the distance S3from the initial position shown inFIG. 11to a second position shown inFIG. 12against the frictional resistance of the locking ribs40. The movement of the double ended needle assembly10by the distance S3allows the upper sharp tip55aof the double ended needle55to pass through the through hole30formed on the partition wall31, and then, to project inward of the second cylindrical part12, so as to pierce the rubber packing23of the second syringe2, thus unsealing the second syringe2. As a consequence, the first and second syringes1and2communicate with each other via the double ended needle55.

Here in the operation in the second stage, at the same time when the finger hooking projected piece51at the intermediate holder3is moved upward inside of the guide groove34, the upper rib52of the finger hooking projected piece51is moved upward inside of the sub guide groove35. Moreover, after the operation in the second stage, the stopper22of the push rod15of the first syringe1is detached.

(3) Operation in Third Stage

As shown inFIG. 12, the push rod15of the first syringe1is operated by one hand of an operator while the push rod16of the second syringe2is operated by the other hand of the operator in the state in which the first and second syringes1and2communicate with each other, thereby mixing the attached solvent L with the lyophilized product M, and further, strongly agitating them, followed by speedy dissolution. For example, the index and middle fingers of one hand hook on the finger hooking projected piece51of the intermediate holder3, and further, the thumb pushes the push rod15. Moreover, the index and middle fingers of the other hand hook on the finger gripping flange43at the upper end of the connection holder6, and further, the thumb pushes the push rod16. Thus, as shown inFIGS. 13 and 14, both of the push rods15and16are alternately pushed, thereby mixing the attached solvent L with the lyophilized product M, dissolving the lyophilized product M in the attached solvent L, and producing the liquids and solutions (i.e., the liquid medicine) M′.

(4) Giving Stage

After the production of the liquids and solutions M′, all of the liquids and solutions M′ is contained in the first syringe1, as shown inFIG. 14, and then, the first syringe1is withdrawn from the first cylindrical part11together with the intermediate holder3. And then, as shown inFIG. 15, a holder61of a special-purpose needle60is inserted into the outer cylindrical portion45at the upper end of the intermediate holder3, and further, the other end of the special-purpose needle60pierces the rubber packing18, thereby unsealing the first syringe1again. As a consequence, the first syringe1serving as a syringe gives the liquid medicine.

[Effects which Mode Carrying Out Invention Produces]

(1) According to the carrying-out mode, as shown inFIGS. 13 and 14, in the state in which the second syringe2containing the lyophilized product M therein, the first syringe1containing the attached solvent L therein, and the double ended needle assembly10for allowing both of the first and second syringes1and2to communicate with each other are held in the predetermined positional interrelationship by the single connection holder6, the attached solvent L can be mixed with and dissolved in the lyophilized product M. Thus, the mixture and dissolution can be readily implemented while the predetermined positional interrelationship among both of the syringes1and2and the double ended needle assembly10can be stably held even by an inexperienced person, unlike the prior art in which the solution is sucked up from the vial, as shown inFIGS. 18 and 19.

(2) The attached solvent L is mixed with and dissolved in the lyophilized product M by the use of the first syringe1containing the predetermined quantity of attached solvent L therein and the second syringe2containing the predetermined quantity of lyophilized product M therein. Thus, the liquid medicine can be accurately produced in the predetermined concentration and quantity, unlike the prior art, in which the predetermined quantity of solution is sucked up from the vial based on the visual measurement, as shown inFIG. 19.

(3) The mixture and the dissolution can be performed in the state in which all of the syringes1and2and the double ended needle assembly10are contained inside of the connection holder6, thus enhancing operational safety and improving sanitation without any spattering of the liquid medicine outside even if the liquid medicine leaks from the syringe during the operation. In addition, the mixed and dissolved liquid medicine M′ is contained inside of the first syringe1, so that the first syringe1and the intermediate holder3serving as the syringe as they are can be utilized in giving the liquid medicine to a person, thus enhancing operational efficiency.

(4) The operation in the first step, in which there are provided the locking ribs40for locking the double ended needle assembly10inside of the first cylindrical part11at the initial position, at which nothing acts on the second syringe2, the locking means (i.e., the finger hooking projected piece51) for locking the intermediate holder3inside of the first cylindrical part11at the standby position, at which nothing acts on the double ended needle assembly10at the initial position, and the unlocking means (i.e., the guide groove34) for the locking means, thus pushing the first syringe1into the locked intermediate holder3, so as to unseal the first syringe1; and the operation in the second step, in which the locking means is unlocked, so that the double ended needle assembly10is pushed from the initial position to the second position together with the first syringe1and the intermediate holder3, so as to unseal the second syringe2, thus allowing both of the syringes1and2to communicate with each other, are necessarily performed in this order. Thus, the mixing and dissolving operations can be performed without any mistake of the operational order even by an inexperienced person. Specifically, in the operation in the first step, the first syringe1on the side of the solution is unsealed by piercing the first syringe with the needle sharp tip55bof the double ended needle assembly10, so that the first syringe1is deaerated. Thereafter, both of the syringes1and2communicate with each other by piercing the second syringe2with the needle sharp tip55bof the double ended needle assembly10, followed by the mixing and dissolving operations. Thus, it is possible to prevent any generation of bubbles in the lyophilized product, so as to smoothly dissolve the lyophilized product.

(5) The finger hooking projected piece51having the function of hooking the finger during the operation is formed as the locking means for locking the intermediate holder3at the standby position, and further, the guide groove34as the unlocking means is formed at the connection holder6. Thus, the fabrication is easy, and further, the unlocking operation also is easy since the lock can be unlocked only by rotating the intermediate holder3.

(6) Since the ribs40as the means for locking the double ended needle assembly10at the initial position are merely formed at the inner circumferential surface of the first cylindrical portion, the fabrication is easy.

INDUSTRIAL APPLICABILITY

Although the syringe device and the method of preparing the liquids and solutions using the device according to the present invention are principally utilized in the fabrication of medical equipment and in a medical industry as a device and method of handling a medical liquids and solutions, they may be utilized in processing liquids and solutions for growing a plant, a study and the like.