Title of Invention

A DRUG MIXING AND DELIVERY DEVICE

Abstract A medicine mixer for applying drug comprises a menstruum vial (12), an outer cannula (2) and a solute vial (11) (powdered drug ampoule) which are in one. Retaining ring (1), chuck ring (4) and convex ring (8) are disposed respectively at up portion, middle portion and nether portion of the inner wall of the outer cannula (2). An inner cannula (5) with a ducting needle (3) is disposed between the chuck ring (4) and the convex ring (8). In use the lower end of the outer cannula (2) is inserted to the opening (14) of the solute vial (11), and the opening (13) of the menstruum vial (12) is inserted into the retaining ring (1) of the outer cannula (2), so that rubber plugs (10,9) are pierced successively by the ducting needle (3) to connect two vials and thus mix drug. Then the outer cannula (2) is unfixed and the drug is applied to an infusion bottle (15). A medicine mixer for applying drug which can be repositioned automatically and a medicine mixer for applying drug which can delivery drug to many ampoules are also provided. The structure of the device is simple and cost is low. It is suitable to be combined with commercial ampoules. It is used conveniently and simply, and applied broadly.
Full Text FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
[See section 10, Rule 13]
MEDICINE MIXER FOR APPLYING DRUG;
ZHONGSHAN BOTAI PHARMACEUTIC
INSTRUMENTS CO., LTD.., A
CORPORATION ORGANIZED AND
EXISTING UNDER THE LAWS OF CHINA, WHOSE ADDRESS IS ROOM 107, NO.8, KANGLE AVENUE, TORCH DEVELOPMENT ZONE, ZHONGSHAN CITY, GUANGDONG PROVINCE, P.R.CHINA, 528437
THE FOLLOWING SPECIFICATION
PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED.
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BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
The present invention relates to a drug mixing and delivery device, particularly to a drug mixing and delivery device having a pressurized solvent vial. The present invention also relates to a drug mixing and delivery device which can be repositioned automatically and a drug mixing and deliver device which can inject the solvent from one solvent vial into a plurality of solute vials containing powdered drugs for reconstitution.
DESCRIPTION OF THE RELATED ART
Conventionally, during a transfusion operation to a patient, a nurse or medical personnel will firstly draw some water for injection (i.e. a solvent to be mixed with a powdered drug) with an ordinary syringe and then inject the solvent from the syringe into a vial, for example, a solute vial containing powdered drug, and then withdraw the drug solution fully dissolved with the powdered drug from the solute vial back into the syringe, and then inject the drug solution into a transfusion bottle. The whole operation has the problem of low work efficiency and risk of contamination to the drug and the medical devices because of its complicated operation procedure. A prior art syringe having two vials pre-sealed with a solvent and a solute respectively positioned vertically against each other in a head-to-head fashion have been disclosed. In one mode the upper bottle is a pressurized vial and the lower bottle is a cartridge. In another mode both the upper and the lower bottles are cartridges. Although this prior art syringe simplifies the operation, still its structure is complicated thus not only
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increasing the cost but also required a special type of vials not compatible with the existing commercial vials commonly found in the market.
SUMMAY OF THE INVENTION
It is an objection of the present invention to provide a drug mixing and delivery device which can simplify the drug mixing and delivery (i.e. reconstitution of powered drugs) operation and at the same time the device can make use of existing vials containing powdered drugs without need of a special type of vials.
In order to fulfill the foregoing object an other objects, the drug mixing and delivery device according to the present invention includes an outer sleeve, an inner sleeve, a hollow needle and a pressurized solvent vial. The inner sleeve is inserted into the outer sleeve with the inner sleeve and the outer sleeve being movable against each other along the center axis of the sleeves. The needle goes through the center of the outer and inner sleeves along the center axis. A collar engaging with the mouth of the solvent vial is formed on the inner wall of the outer sleeve at one end. A flange is formed one the inner wall of the outer sleeve in the middle portion. A circular bulging portion is formed on the inner wall of the outer sleeve at the on the end. One end of the inner sleeve is sealed and a collar bending inwardly is formed on the inner wall of the inner sleeve near the opening end. The inner sleeve is positioned between the flange and the circular bulging portion with its open end pointing outwardly. The hollow needle goes through the inner sleeve along its center axis and is fixed to the inner sleeve in the center of the sealed end of the inner sleeve.
Preferably, in the drug mixing and delivery device according to claim, the cross-section of the collar is in a shape of a triangle and the inner diameter of the flange is smaller than that of
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the collar and the circular bulging portion. Expansion joints are formed in the outer sleeve at the side engaging with the inner sleeve.
When the drug mixing (reconstitution) operation is completed, it is required pull up the solute vial or the outer sleeve so that the hollow needle can withdraw from the rubber stopper of the solute vial.
In order to solve the problem of the foregoing embodiment in which the needle can not withdraw by itself. An automatic repositioning drug mixing and delivery device is proposed. The device comprises an outer sleeve, an inner sleeve, a hollow needle, a elastic member and a pressurized solvent vial in which the inner sleeve is inserted into the outer sleeve and is movable against the outer sleeve along a longitudinal center axis of the sleeves. The hollow needle pierces through the center portion of the outer sleeve and the inner sleeve along the center axis. A distance plate having a center hole is provided inside the outer sleeve and a distance piece is provided on the inner sleeve coupled to the solvent vial. One end of the hollow needle extends out of the distance piece of the inner sleeve and fixed to the distance piece. A elastic member is provided between the distance plate of the outer sleeve and the distance piece of the inner sleeve; the outer sleeve and the inner sleeve are respectively provided with retaining members engaging with each other.
In a preferred embodiment, the end of the hollow needle extending out the distance piece of the inner sleeve is provided with a protective sheath, while the other end of the hollow needle is positioned inside a thorough hole formed on the distance plate. The elastic member is a spring or a elastic rubber sheath.
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In a preferred embodiment, the distance piece is positioned inside the inner sleeve. A round bulge is formed on the inner wall of the inner sleeve at one end of the inner sleeve. The round bulge and the mouth of the solvent vial is tightly fitted (interference fitted) with each other.
In a preferred embodiment, the distance piece is positioned at the top portion of the inner sleeve and the diameter of the distance plate is greater than that of the outer sleeve.
In a preferred embodiment, a round bulge is formed on the inner wall of the outer sleeve at one side. The round bulge and the mouth of the solute vial is tightly fitter (interference fitted ) with each other.
In a preferred embodiment, one side of the outer sleeve is provided with expansion joints along the axial direction and a collar is formed on the inner wall of the outer sleeve. The distance between the outer sleeve and the distance plate equals to or slightly greater than the thickness of the outer edges of the mouth of the solute vial.
In a preferred embodiment, the retaining members are sliding channels having locking notches formed in opposite direction on the inner wall of the outer sleeve and clippers formed on the outer wall of the inner sleeve engaging with the sliding channels and the locking notches.
In a preferred embodiment, the retaining members are open grooves having locking holes formed in opposite direction on the inner wall of the outer sleeve and clippers formed on the outer wall of the inner sleeve engaging with the open grooves and the locking holes.
In clinical practice it is usually necessary to delivery powdered drugs contained in 3 - 5 numbers of the vial into the transfusion bottle at one time in order to satisfy the volume of
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dosage required for treatment. Because of the volume and the structure of the above embodiments, one powdered drug vial has to consume one drug mixing and delivery device, increasing the cost and wastes.
In order to solve the problem of one drug mixing and delivery device can only be used for one time with one powdered drug vial. A drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials is proposed. The device comprises an outer sleeve, a bush, an inner support, an inner sleeve, a hollow needle, elastic members and a pressurized solvent vial. The inner sleeve is inserted in the outer sleeve and movable against the outer sleeve along a longitudinal center axis of the sleeves. The hollow needle pierces through the center portion of the outer sleeve and the inner sleeve along the center axis. The outer sleeve is connected to the bush provided with a movable plate therein. The elastic members are provided above and below the movable plate respectively. The movable plate is confined within the bush by a collar. The inner support is positioned within the outer sleeve. The hollow needle is fixed to the movable plate and positioned inside a thorough hole formed in the inner support and a thorough hole formed in the bush. An end cap is connected to the outer sleeve via a ripping ring. The inner sleeve is inserted into the end cap.
Preferably, in the drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials of the invention, the upper portion of the inner sleeve engages with the mouth of the solvent vial and the lower portion of the bush engages with the mouth of the solute vial. An annular step or a bulge is formed on the upper portion of the inner sleeve. The maximum traveling distance of the inner support is defined by an annular step formed inside the outer sleeve. The elastic member is a spring or an elastic rubber sheath.
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The drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials of any of the present invention can distribute the solvent contained in a pressurized large volume vial into a plurality of solute vials containing powdered drugs and transfer these vials into a kind of pressurized vials containing reconstituted drug solution one by one. Then the drug solutions contained in the vials can be delivered into a transfusion bottle one by one utilizing the same drug mixing and delivery device. This embodiment solves the problem existed in the previous embodiments which consume a drug mixing and deliver device each time the drug in a solute vial is reconstituted and delivered. Therefore this embodiment is more suitable for clinical use because the operation is simplified and the cost is reduced.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a vertical section view of the drug mixing and delivery device of the present invention;
FIG. 2 is a top view of FIG. 1;
FIG. 3 is a view of the drug mixing and delivery device of the present invention showing a solvent vial and a solute vial in a status of being communicated with each other.
FIG. 4 is a view of the drug mixing and delivery device of the present invention showing the solvent vial and the solute vial in a status of not being communicated with each other.
FIG. 5 is a view of the drug mixing and delivery device of the present invention showing the solute vial and the inner sleeve without the outer sleeve.

FIG. 6 is a view showing the drug mixing and delivery device of the present invention delivering mixed drug solution to a transfusion bottle.
FIG. 7 is a view of the automatic repositioning drug mixing and delivery device of the present invention showing the solvent vial in a status of not communicating with the solute vial;
FIG. 8 is a view showing the automatic repositioning drug mixing and delivery device of the present invention showing the solvent vial in a status of communicating with the solute vial;
FIG. 9 is a view showing the automatic repositioning drug mixing and delivery device of the present invention without the solvent vial;
FIG. 10 is a partial perspective view showing the outer sleeve of the automatic repositioning drug mixing and delivery device of the present invention
FIG. 11 is top a view showing the inner sleeve of the automatic repositioning drug mixing and delivery device of the present invention
FIG. 12 - FIG. 16 show some variations of the inner sleeves of the automatic repositioning drug mixing and delivery device of the present invention;
FIG. 17 is a view showing another automatic repositioning drug mixing and delivery device of the present invention;
FIG. 18 is a view showing the other automatic repositioning drug mixing and delivery device of the present invention without the solute vial;
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FIG. 19 is a view of the drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of vials of the present invention showing the solvent vial in a status of not communicating with the solute vial;
FIG. 20 is a view of the drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of vials of the present invention showing the solvent vial in a status of communicating with the solute vial;
FIG. 21 is a view of the drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of vials of the present invention delivering mixed drug solution to a transfusion bottle;
DESCRIPTION OF THE PREFERRED EMBODIMENT
1. Drug mixing and delivery device of the present invention
The drug mixing and delivery device of the present invention delivers a mixed drug solution into the transfusion bottle by utilizing a internal pressure generated inside the solute vial 11 when the solvent in a solvent vial 12 is injected into the solute vial 11 to push the mixed drug solution out of the solute vial 11.
As shown in FIG. 3 and FIG. 4, the drug mixing and delivery device of the present invention generally includes a solvent vial 12, a sleeve portion and a solute vial 11 connected together. The solvent vial 12 stands upside down with its mouth 13 inserted into the upper
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portion of an outer sleeve 2 and a mouth 14 of the solute vial 11 inserted into an lower portion of the outer sleeve 14.
As shown in FIG. 1 and FIG. 2, a collar 1 with triangle-shaped cross-section, and flange 4 with rectangle-shaped cross-section and a circular bulging portion 8 are respectively formed on the upper, middle and lower portion of the inner wall of the outer sleeve 2 of the drug mixing and delivery device of the present invention. A plurality of expansion joints 7 are formed longitudinally between the flange 4 and the bottom edge of the outer sleeve 2 and the. The inner sleeve 5 positioned in the lower portion of the outer sleeve 2 is similar to a bottle cap in its structure. A collar 6 bending inwardly is formed along the bottom edge of the inner sleeve 5 to engage with the bottom edge of the mouth 14 of the solute 11. The hollow needle 3 is fixed the center of the inner sleeve along the center axis.
When using the drug mixing and delivery device of the present invention, firstly, the mouth 14 of the solute 11 is inserted into the collar 6 formed on the inner sleeve 5 so that the hollow needle 3 pierces through a rubber stopper 10 of the solute vial, then the mouth 13 of the solvent vial 12 is downwardly inserted into the collar 1 formed on the outer sleeve 2 so that the needle 3 pierces through the rubber stopper 9 of the solvent vial thus beginning the drug mixing operation, as shown in FIG. 3.
Alternatively, the solvent vial 12 can be previously assembled with the sleeve portion as a whole. This will also result in communicating with the solute vial 11 and the solvent vial 12 consecutively or simultaneously by the following steps: during the manufacturing, the mouth 13 of the solvent vial 12 is inserted into the outer sleeve 2 from the side of collar 1 until the mouth 13 reaches the collar 1. The solvent vial 12 will not continue to move in because of the
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collar 1 functioning as a positioning point during mass production. The solvent vial 12 and the outer sleeve 2 are in a relatively fixed position against each other and can be packed as a whole assembly for clinical applications. When in use, a nurse or medical personnel only needs to apply a slight force to insert the solute vial 11 into the other side of the outer sleeve 2 so that the mouth 14 of the solute vial 11 will goes into the inner sleeve 5 to begin with the drug mixing, as shown in FIG. 4. When the drug mixing begins, the solvent vial 12 which is in an upside down position is pushed downwardly. It will be appreciated that the pushing force applied to the solvent vial 12 will also be applied to the collar 1. Because a flange 4 and the outer sleeve 2 are formed as an whole part and the flange 4 also engages with the upper portion of the inner sleeve 5, therefore when the solvent vial 12 is pushed downwardly, both the outer sleeve 2 and the inner sleeve 5 will move downwardly, forcing the mouth 14 of the solute vial 11 into the collar 6 of the inner sleeve 5.
When the mouth 14 of the solute vial 11 reaches to the inner end face of the inner sleeve 5, the lower end of the needle 3 will definitely pierce through the rubber stopper 10 so that the solute vial 11 is communicated with the needle 3, and the collar 6 of the sleeve 5 will definitely be in a position beneath the mouth 14 of the solute vial 11. The solvent vial 12 is then continuously pushed downwardly, this time the upper end of the needle 3 will necessarily pierces through the rubber stopper 9 of the solvent vial 12 so that the solvent vial 12 is also communicated with the needle 3. Then the liquid in the solvent vial 12 will immediately be injected into the solute vial 11 through the need 3 because of the inner pressure inside the solvent vial 12 so that the powdered drugs inside the solute vial 11 is dissolved sufficiently or is fully mixed with the liquid from the solvent 11 to completed the drug mixing operation.
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Because solvent vial 12 has already been pressurized in the manufacturing factory, so when the solvent vial 12 and the solute vial 11 are communicated with each other through the needle 3, the pressure inside the solvent 12 will go into the solute vial 11 through needle until the pressure within the two vials are balanced, as shown in FIG. 3.
Because the distance between the collar 1 and the flange 4 equals to or slightly greater than the thickness of the mouth 13 of the solvent vial, therefore the mouth 13 of the solvent vial 12 has been tightly snapped between the collar 1 and the flange 4. Upon removing the outer sleeve and the solvent vial 12 after the drug is properly mixed, the solvent vial 12 is pulled upwardly. As the solvent 12 being pulled upwardly, the outer sleeve 5 will also move upwardly because the mouth 13 of the solvent vial 12 underneath the collar 1 of the outer sleeve 2 is engaging with the collar 1 at this point. At the same time, the inner sleeve 5 will also move upwardly because a circular bulging portion 8 formed on the outer sleeve 2 engages with the collar 6 formed on the bottom portion of the inner sleeve 5 until the collar 6 of the inner sleeve 5 engages with the bottom face of the mouth 14 of the solute bottom 11. At this point the inner sleeve 5 is in its highest position but still does not disengages with solute vial 11, and the lower end of the needle 3 is pulled out of the rubber stopper 10. Continuously pulling the solvent vial 12 upwardly, the circular bulging portion 8 will move upwardly along the outer wall of the inner sleeve 5 because of an expansion joint 7 until the outer sleeve 2 disengages with inner sleeve 5 completely. At this point the needle 3 is still kept above the mouth 14 of the solute vial 11 because the collar 6 formed on the lower portion of the inner sleeve 5 tightly retains the lower edges of the mouth 14 of the solute vial 11, forming an pressurized automatic syringe, as shown in FIG. 5.
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Alternatively, the above procedure can be performed by holding and pulling the outer sleeve 2 upwardly to achieve the same effect and result.
Then the solute vial 11 is held by hand and turned upside down to delivery the mixed drug inside the solute vial 11 into a transfusion bottle 15. As shown in FIG. 6, when one end of the needle 3 is pierced into a stopper 16 of the transfusion bottle 15, the counteracting force will make the other end of needle 3 pierce through the rubber stopper 10 of the solute vial 11. Then the pressure inside the solute vial 11 is high enough to inject the mixed drug from the solute vial 11 into the transfusion bottle 15 to complete a one-time drug delivery operation.
In addition, in order to better engages with the mouths of the solvent vial 12 and the solute vial 11, the outer sleeve 2 can having different inner diameters by forming a step in the middle of the outer sleeve 2.
The above operations are performed "at a heat". The drug mixing and delivery device of the present invention has many advantages: no only the drug mixing and delivery time is saved avoiding a possible secondary contamination because the need for transferring the drug solution is eliminated, but also an automatic syringe with readily mixed(diluted) powdered drug are formed eliminating the need for a syringe for drawing out the solvent.
Additionally, the upper end of the needle within the inner sleeve can be provided with an elastic rubber sheath to protect the needle from being contaminated. The rubber sheath will extend automatically to cover the needle end after the drug is delivered to protect the operator from being hurt by the needle.
Additionally, because the inner pressure of the insolvent vial has to be added by special means, so the drug mixing and delivery device of the present invention is desirably
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self-destructive type which is environmental friendly and cannot be used again which is illegal.
Another feature of the drug mixing and delivery device of the present invention is that the three sections can either be packed in aseptic packages independently, or the solvent vial and the sleeve portion can be assembled and packed together, or even all the three sections can be assembled together in the factory and packed in one aseptic packages to facilitate the operation and eliminate the possibility of mixing the wrong drugs.
2. The drug mixing and delivery device of the present invention which can be repositioned automatically.
As shown in FIG. 7 the automatic repositioned drug mixing and delivery device of the present invention generally comprises a outer sleeve 22, an inner sleeve 25, a hollow needle 23, a elastic member 210, a solvent vial 12 and a solute vial 11. A distance piece 29 is formed transversely inside the inner sleeve 25. A plurality of spaced round bulges 215 are formed on the inner wall of the inner sleeve 25 above the distance piece 29. Two clippers 21 are symmetrically formed outwardly at the lower end portion on the outer wall of the inner sleeve 25. A distance plate 20 is formed transversely inside the outer sleeve 22. A plurality of spaced round bulges 28 are formed on the inner wall of the outer sleeve below the distance plate 20. Refer to FIG. 10, a pair of channels 24 is symmetrically formed in the inner wall of the outer sleeve 22. Two locking notches 26 are formed on the ends of the pair of channels 24 in opposite directions to each other, as shown in FIG. 10. The two clippers 21 formed at the
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lower end portion on the inner wall of the inner sleeve 25 can be inserted into and move in the channels 24 or the locking notches 26. The hollow needle 23 with two piercing ends is fixed to the distance piece 29 of the inner sleeve 25. One end of the needle 23 extends out of the distance piece 229, and the other end of the needle 23 is positioned inside a through hole 212 formed in the center of the distance plate 20 of the outer sleeve 22. The spring 210 around the needle 23 is positioned between the distance piece 29 and the distance plate 20. The outer edge of the mouth of the pressurized solvent vial 12 is tightly fitted (interference fit) with the round bulges 215 formed on the inner wall of the inner sleeve 25, and the outer edge of the mouth of the solute vial 11 which is an ordinary commercial powdered drug vial is tightly fitted (interference fit) with the round bulges 28 formed on the inner wall of the outer sleeve 22. FIG. 7 only shows the not communicated solvent vial and the solute vial.
In order to communicate the solvent vial 12 with the solute vial 11 to mix (dilute) the powdered drug, the solvent vial 12 is pressed downwardly with a hand and the inner sleeve 25 will move downwardly by the force and press against the spring 210. The clippers 21 will slide along the channel 24 downwardly until they reach the locking notches 26, meanwhile the upper end of the needle 23 will pierce through the rubber stopper 9 of the solvent vial 12. When the clippers 21 reach the locking notches 26, the lower end of the needle 23 will pierce through the rubber stopper 10 of the solute vial 11 so that the two vials communicates with each other and the liquid inside the solvent vial 12 will go into the solute vial 11 through the needle 23 under the pressure prefilled inside the solvent vial 12, thus completing the drug mixing operation, as shown in FIG. 8. At this point, the solute vial 11 contains the well mixed drug solution with inner pressure.
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When the drug mixing is completed, the inner sleeve 25 is looses and moves upwardly, the sleeve 25 will be pushed to its highest position by the spring 210 because the external force applied by the hand has been removed, as shown in FIG. 9. At the same time the lower end of the needle 23 moves out of the rubber stopper 10 of the solute vial 11. Then the solvent vial 12 is removed and the solute vial 11 is turned upside down. Then the end of the needle 23 extending out of the distance piece 29 is pierced into the rubber stopper of the transfusion bottle. The clippers 21 of the inner sleeve 25 will again slide to the locking notches 26 along the channels 2 because of the counterforce, and the needle 23 will again pierce through the rubber stopper 10 of the solute vial 11 (just like the solvent vial 12 in FIG. 8 is replaced with the transfusion bottle in a upside down position). The mixed drug solution will be injected into the transfusion bottle under the inner pressure inside the solute bottle completing a one-time drug delivery to the transfusion bottle operation and ensuring both the drug mixing and delivery operation are performed under aseptic condition.
The locking notches 26 functions as retaining the communication between the solvent vial 12 and the solute vial 11 by slightly rotating the inner sleeve clockwise so that the clippers 21 go into the locking notches 26 when the clippers 21 reaches to the locking channels 26 along the channels 24. Of course, the locking notches 26 can be omitted because the communication between the solvent vial 12 and the solute vial 11 can be retained simply by pressing the solvent vial 12 or the inner sleeve 25 with a hand. The needle 23 will disengage with the rubber stopper 10 as soon as the hand is loosed. Of course, other means can be used for retaining the position, such as a retaining ring, a protruding ring or a positioning step, etc. The spring 210 can also be a sleeve made of elastic rubber in stead of a spring.
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FIG. 12 - FIG. 16 show various other possible embodiments of the end of the inner sleeve 25 mating with the solvent vial.
FIG. 17 and FIG. 18 show another embodiment of the automatic repositioning drug mixing and delivery device of the present invention. The difference between this and the other embodiment is that the portion above the distance piece 29 of the inner sleeve is removed so that the mating ends of a inner sleeve 205 and the solvent vial 12 is a plane (just like FIG. 12). And two open grooves 204 and two open locking holes 206 engaging with two clippers 201 formed on the inner sleeve 205 are formed the side wall of the outer sleeve 202 instead of the channels 24 and the locking notches 26 formed on the outer sleeve 22. The end mating of the outer sleeve 202 mating with the mouth 14 of the solute vial is reduced to a socket in its radial direction. The round bulge formed on the outer sleeve 202 is moved to the edge of the socket forming a collar 208. The side wall of the socket is formed with a plurality of vertical expansion joints 207 in equal distances. When the solvent vial 12 is disengaged with the inner sleeve 205, the protruding end of the needle 203 can be covered with a protective sheath 213 made of hard material. The opening end of the sheath 213 is inserted into a recess portion 214 formed in the center of the distance piece to protect the needle from contamination or damage, and from incidentally hurting people as well.
3. Drug mixing and delivery device for reconstituting powered drugs contained in a plurality of powdered drug vials of the present invention
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As shown in FIG. 19, a drug mixing and delivery device for a plurality of powdered drug vials of the present invention generally comprises an outer sleeve 318, a bush 33, a inner support 313, a inner sleeve 310, a hollow needle 37, a spring 314, a spring 34 and a large solvent vial 39. The bush 33 is fixed to the closing end of the outer sleeve 318 and the outer portion of the bush 33 is provided with a movable plate 35 fixed with the needle 37. The spring 34 is set between the movable plate 35 and the bottom portion of the bush 33. The maximum travel distance of the movable plate 35 within the bush 33 is defined by a collar 316 formed on the inside of the upper portion of the bush 33. The inside of the outer sleeve 318 is also provided with an inner support 313 having a needle hole. The spring 314 is set between the inner support 313 and the movable plate 35. The maximum travel distance of the inner support 313 inside the outer sleeve 318 is defined by an annular step 36. The top end of the outer sleeve 318 is provided with an end cap 311 coupled to the outer sleeve 318 through a ripping ring 312. An annular step 317 formed on the inside of the inner sleeve 310 forms the socket of the solvent vial. The end cap 311 engages with a step 32 formed on the lower portion of the inner sleeve 310 so that the inner sleeve 310 can not be pulled out upwardly.
When the two vials are not communicated with each other, the spring 34 will push the movable plate 35 upwardly until it reaches the collar 316 and the spring 314 will push the inner support 313 upwardly until it reaches the annular step 36 inside the outer sleeve 318, thus all parts being in their initial positions.
In the drug mixing operation, the large solvent vial 39 is pushed downwardly with a little force. The annular step 317 will be pressed by the stopper 38 of the large solvent vial 39 so that the inner support 31 will be pressed by the inner sleeve 310 accordingly. Then the
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movable plate 35 will be pressed by the compressed spring 314 downwardly pressed by the inner support 313. Meanwhile, the needle 37 will pierce through the stopper 14 of the solute vial 11 through a thorough hole 315 and at the same time the needle 37 will pierce through the stopper 38 of the large solvent vial 39, thus two vials being communicated via the needle 37, as shown in FIG. 20. Because the large solvent vial 39 is pre-filled with pressure and the vial body is marked with scales, the solvent in the large solvent vial 39 will go into the solute vial 11 via the needle 37 to begin with the drug mixing. The large solvent vial 39 is pulled up when the remaining solvent in the large solvent vial 39 is dropped to a desired level so that all parts restore back to their initial positions.
The above operation can be repeated so that the solvent in the large solvent vial 39 can be introduced into several solute vials 11 to mix the drugs and pressurize the solute vials 11 by using only one drug mixing and deliver device to prepare for the next operation of delivering the drug solution from the solute vials to transfusion bottles.
During the drug delivery operation for delivering the mixed drug solution in the solute vials 11 into the transfusion bottles, the ripping ring 312 is ripped off by hand so that the end cap 311, the inner sleeve 310 together with the large solvent vial 39 and the outer sleeve 318 are separated. Then, as shown in FIG. 21, the outer sleeve 318 and the solute vial 11 is turn upside down making the out sleeve 318 covers the mouth of the transfusion bottle 320. Then the solute vial 11 is pressed down by force so that the parts inside the outer sleeve 318 are again in their positions as shown in FIG. 20. At this tie, the needle 37 pierces through the stopper 319 of the transfusion bottle 320 and the drug solution in the solute vial 11 is injected into the transfusion bottle 320. Replace the solute vial 11 with another to repeat the above
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operation will deliver mixed drug solutions from several solute vials into the transfusion bottle 320.
Only one drug mixing and delivery device is required to distribute the solvent in one solvent vial into several solute vials containing powdered drugs, making them into pressurized drug vials so that it is possible to deliver the mixed drug solutions from several solute vial into a transfusion bottle. This will reduce the number of the drug mixing and delivery device required and facilitate easy operation and reduce the cost.
INDUSTRIAL APPLICABILITY
When using the drug mixing and delivery device of the present invention, it is only required to insert the mouth of a solvent vial in upside down position into the corresponding mating portion of the device and insert a solute vial containing powdered drug into the opening end of an inner sleeve of the device and then press the solvent vial so that the two ends of a hollow needle pierces through the rubber stoppers of the solvent vial and the solute vial respectively to communicate the two vials, then the solvent in the solvent vial will go into the solute vial under the inner pressure inside the solvent vial to mix with the powdered drug in the solute vial. After the drug is mixed, separate the solvent vial together with the outer sleeve by pulling up the solvent vial, then the solute vial engaged with the inner sleeve having the hollow needle forms a pressurized syringe. Deliver the mixed drug solution in the solute vial into a transfusion bottle by piercing the hollow needle through a rubber stopper of the transfusion bottle and pressing the solute vial. The drug mixing and delivery device of the present invention having a simple structure reduces the possibility of contamination, improves work efficiency by its simplified operation.
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In addition to the features mentioned above, the drug mixing and delivery device which can be automatic repositioned has the following features: after the drug mixing operation is completed, the hollow needle will move out from the rubber stopper of the solute vial and the solute vial will restore to a sealed condition automatically under the elastic force of a elastic member. In the case than the volume of the solvent vial and the solute vial is large requiring longer time of drug mixing, it is possible to maintain the communication between the two vials by engaging the clippers (locking hooks) on the outer wall of the inner sleeve into the locking notches (locking holes) rotate the inner sleeve by pressing the solvent vial until it reaches to the bottom and than rotating the inner sleeve along the direction of the locking notches (holes) on the inner wall of the outer sleeve. When the drug mixing operation is completed, disengage the clippers (hooks) from the locking notches (holes) by rotating the inner sleeve in a reverse direction and the hollow needle will move out from the rubber stopper of the solute vial.
The drug mixing and delivery device for reconstituting drugs contained in several solute vials drugs can distribute the solvent in a large solvent vial into to several solute vials containing powered drugs and at the same time pressurize the solute vials. Then the mixed drugs in the several solute vials can be delivered into a transfusion bottle one by one by using the same drug mixing and delivery device. This eliminates the need for consuming a drug mixing and delivery device for each solute vial and thus simplifying the operation and reducing the cost, which is desirable for clinical needs.
21

WE CLAIM
1. A drug mixing and delivery device characterized in that the device comprises an outer
sleeve (2), an inner sleeve (5), a hollow needle (3) and a pressurized solvent vial (12);
wherein,
the inner sleeve (5) is inserted into the outer sleeve (2) and is movable against the outer sleeve (2) along its longitudinal center axis; the hollow needle (3) pierces through a center portion of the outer sleeve (2) and the inner sleeve (5) along the center axis;
a collar (1) engaging with a mouth (13) of the solvent vial (12) is formed on the inner wall of the outer sleeve (2) at one end of the outer sleeve (2); a flange (4) is formed on a center portion of the inner wall of the outer sleeve (2); a circular bulging portion (8) is formed on the inner wall of the outer sleeve (2) at the other end of the outer sleeve (2); one end of the inner sleeve (5) is sealed and a round collar (6) is formed on the inner wall of the inner sleeve (5) at the open end of the inner sleeve (5); the inner sleeve (5) is positioned between the flange (4) and the circular bulging portion (8) with the opening end pointing out; the hollow needle (3) is fixed to the inner sleeve (5).
2. The drug mixing and delivery device according to claim 1 characterized in that the
cross-section of collar 1 is in a shape of a triangle and the inner diameter of the flange (4) is
smaller than that of the collar 1 and the circular bulging portion (8).
22

3. The drug mixing and delivery device according to claim 1 or 2 characterized in that expansion joints (7) are formed in the outer sleeve (2) at the side engaging with the inner sleeve (5).
4. A automatic repositioning drug mixing and delivery device characterized in that the device comprises an outer sleeve, an inner sleeve, a hollow needle, a elastic member and a pressurized solvent vial (12); wherein,
the inner sleeve is inserted into the outer sleeve and is movable against the outer sleeve along a longitudinal center axis of the sleeves; the hollow needle pierces through the center portion of the outer sleeve and the inner sleeve along the center axis;
a distance plate having a center hole is provided inside the outer sleeve and a distance piece is provided on the inner sleeve coupled to the solvent vial (12); one end of the hollow needle extends out of the distance piece of the inner sleeve and fixed to the distance piece; a elastic member is provided between the distance plate of the outer sleeve and the distance piece of the inner sleeve; the outer sleeve and the inner sleeve are respectively provided with retaining members engaging with each other.
5. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that the elastic member is a spring or a elastic rubber sheath.
6. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that the end of the hollow needle extending out the distance piece of the inner sleeve is provided with a protective sheath, while the other end of the hollow needle is positioned inside a thorough hole formed on the distance plate.
23

7. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that the distance piece (29) is positioned inside the inner sleeve (25); a round bulge (215) is formed on the inner wall of the inner sleeve (25) at one end of the inner sleeve (25); the round bulge (215) and the mouth of the solvent vial (12) is tightly fitted (interference fitted) with each other .
8. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that the distance piece (209) is positioned at the top portion of the inner sleeve (205) and the diameter of the distance plate (209) is greater than that of the outer sleeve (202).
9. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that a round bulge (28) is formed on the inner wall of the outer sleeve (22) at one side; the round bulge (28) and the mouth of the solute vial (14) is tightly fitter (interference fitted ) with each other.

10. The automatic repositioning drug mixing and delivery device according to claim 4 characterized in that one side of the outer sleeve (202) is provided with expansion joints (207) along the axial direction and a collar (208) is formed on the inner wall of the outer sleeve (202); the distance between the outer sleeve (202) and the distance plate (200) equals to or slightly greater than the thickness of the outer edges of the mouth (14) of the solute vial.
11. The automatic repositioning drug mixing and delivery device according to any of the claim 4 through claim 10 characterized in that the retaining members are sliding channels (24) having locking notches (26) formed in opposite direction on the inner wall of the outer sleeve
24

(22) and clippers (21) formed on the outer wall of the inner sleeve (25) engaging with the sliding channels (24) and the locking notches (26).
12. The automatic repositioning drug mixing and delivery device according to any of the claim 4 through claim 10 characterized in that the retaining members are open grooves (204) having locking holes (206) formed in opposite direction on the inner wall of the outer sleeve (202) and clippers (201) formed on the outer wall of the inner sleeve (205) engaging with the open grooves (204) and the locking holes (206).
13. A drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials comprising: an outer sleeve (318), a bush (33), an inner support (313), an inner sleeve (310), a hollow needle (37), elastic members (314, 34) and a pressurized solvent vial (39); wherein,
the inner sleeve (310) is inserted in the outer sleeve (318) and movable against the outer sleeve (318) along a longitudinal center axis of the sleeves; the hollow needle (37) pierces through the center portion of the outer sleeve (318) and the inner sleeve (310) along the center axis;
the outer sleeve (318) is connected to the bush (33) provided with a movable plate (35) therein; the elastic members (314, 34) are provided above and below the movable plate (35) respectively; the movable plate (35) is confined within the bush (33) by a collar (316); the inner support (313) is positioned within the outer sleeve (318); the hollow needle (37) is fixed to the movable plate (35) and positioned inside a thorough hole formed in the inner support (313) and a thorough hole (315) formed in the bush (33); a end cap (311) is connected to the
25

outer sleeve (318) via a ripping ring (312); the inner sleeve (310) is inserted into the end cap (311).
14. The drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials of claim 13 characterized in that an annular step (317) or a bulge is formed on the upper portion of the inner sleeve (310)
15. The drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials of claim 13 characterized in that the maximum traveling distance of the inner support is defined by a annular step (36) formed inside the outer sleeve (318).
16. The drug mixing and delivery device for reconstituting powdered drugs contained in a plurality of solute vials of any of claims 13 through claim 15, characterized in that the elastic member is a spring or an elastic rubber sheath
Dated this 26th day of June, 2007
26

Abstract
A medicine mixer for applying drugs includes a solvent vial (12), an outer sleeve and a solute vial (11) containing powered drugs connect together. A collar (1), a flange (4) and a circular bulging portion (8) are formed on the upper, middle and lower portion of the inside wall of the outer sleeve (2). An inner sleeve (5) with a hollow needle (3) is positioned between the flange (4) and the circular bulging portion (8). When in use, the lower end of the outer sleeve (2) is moved downwardly to the mouth (14) of the solute vial (11) and the mouth (13) of the solvent vial (12) is inserted into the collar (1) of the outer sleeve (2), making the hollow needle (3) pierces through the rubber stoppers (10, 9) consecutively so that the two vial are communicated to begin with the drug mixing operation. Then the outer sleeve (2) is pulled off to delivery the mixed drug solution to a transfusion bottle (15). The present invention also relates to a drug mixing and delivery device which can be repositioned automatically and a drug mixing and delivery device which can reconstitute drugs contained in a plurality of solute vials. The drug mixing and delivery device of the present invention has a simple structure with low cost and is easy to operate, suitable for using with ordinary commercial drug vials.
27

Documents:

966-mumnp-2007-abstract(06-11-2008).doc

966-mumnp-2007-abstract(06-11-2008).pdf

966-MUMNP-2007-ABSTRACT(26-6-2007).pdf

966-MUMNP-2007-ABSTRACT(6-11-2008).pdf

966-MUMNP-2007-ABSTRACT(GRANTED)-(2-2-2009).pdf

966-mumnp-2007-abstract.doc

966-mumnp-2007-abstract.pdf

966-MUMNP-2007-CANCELLED PAGE(6-11-2008).pdf

966-MUMNP-2007-CANCELLED PAGES(6-11-2008).pdf

966-MUMNP-2007-CLAIMS(26-6-2007).pdf

966-MUMNP-2007-CLAIMS(6-11-2008).pdf

966-mumnp-2007-claims(granted)(06-11-2008).doc

966-mumnp-2007-claims(granted)(06-11-2008).pdf

966-MUMNP-2007-CLAIMS(GRANTED)-(2-2-2009).pdf

966-mumnp-2007-claims.doc

966-mumnp-2007-claims.pdf

966-mumnp-2007-correspondence(06-11-2008).pdf

966-MUMNP-2007-CORRESPONDENCE(29-8-2007).pdf

966-MUMNP-2007-CORRESPONDENCE(6-11-2008).pdf

966-mumnp-2007-correspondence(ipo)-(02-02-2009).pdf

966-MUMNP-2007-CORRESPONDENCE(IPO)-(16-5-2008).pdf

966-MUMNP-2007-CORRESPONDENCE(IPO)-(17-2-2009).pdf

966-mumnp-2007-correspondence-received.pdf

966-mumnp-2007-descripiton (complete).pdf

966-MUMNP-2007-DESCRIPTION(COMPLETE)-(26-6-2007).pdf

966-MUMNP-2007-DESCRIPTION(COMPLETE)-(6-11-2008).pdf

966-MUMNP-2007-DESCRIPTION(GRANTED)-(2-2-2009).pdf

966-mumnp-2007-drawing(06-11-2008).pdf

966-MUMNP-2007-DRAWING(26-6-2007).pdf

966-MUMNP-2007-DRAWING(6-11-2008).pdf

966-MUMNP-2007-DRAWING(GRANTED)-(2-2-2009).pdf

966-mumnp-2007-drawings.pdf

966-mumnp-2007-form 1(26-06-2007).pdf

966-mumnp-2007-form 1(26-06-2009).pdf

966-MUMNP-2007-FORM 1(26-6-2007).pdf

966-MUMNP-2007-FORM 1(29-8-2007).pdf

966-MUMNP-2007-FORM 1(6-11-2008).pdf

966-mumnp-2007-form 18(26-06-2007).pdf

966-mumnp-2007-form 2(6-11-2008).pdf

966-MUMNP-2007-FORM 2(COMPLETE)-(26-6-2007).pdf

966-mumnp-2007-form 2(granted)-(06-11-2008).doc

966-mumnp-2007-form 2(granted)-(06-11-2008).pdf

966-MUMNP-2007-FORM 2(GRANTED)-(2-2-2009).pdf

966-MUMNP-2007-FORM 2(TITLE PAGE(6-11-2008).pdf

966-MUMNP-2007-FORM 2(TITLE PAGE)-(26-6-2007).pdf

966-MUMNP-2007-FORM 2(TITLE PAGE)-(GRANTED)-(2-2-2009).pdf

966-mumnp-2007-form 3(03-12-2007).pdf

966-mumnp-2007-form 3(26-06-2007).pdf

966-MUMNP-2007-FORM 3(30-11-2007).pdf

966-MUMNP-2007-FORM 3(6-11-2008).pdf

966-mumnp-2007-form 5(26-06-2007).pdf

966-mumnp-2007-form-1.pdf

966-mumnp-2007-form-18.pdf

966-mumnp-2007-form-2.doc

966-mumnp-2007-form-2.pdf

966-mumnp-2007-form-3.pdf

966-mumnp-2007-form-5.pdf

966-mumnp-2007-form-pct-isa-210(06-02-2008).pdf

966-mumnp-2007-pct-search report.pdf

966-MUMNP-2007-POWER OF ATTORNEY(12-8-2007).pdf

966-mumnp-2007-power of attorney(13-08-2007).pdf

abstract1.jpg


Patent Number 228346
Indian Patent Application Number 966/MUMNP/2007
PG Journal Number 10/2009
Publication Date 06-Mar-2009
Grant Date 02-Feb-2009
Date of Filing 26-Jun-2007
Name of Patentee ZHONGSHAN BOTAI PHARMACEUTIC INSTRUMENTS CO., LTD.
Applicant Address ROOM 107, NO.8, KANGLE AVENUE, TORCH DEVELOPMENT ZONE, ZHONGSHAN CITY, GUANGDONG PROVINCE,P R 52837,
Inventors:
# Inventor's Name Inventor's Address
1 WANG XINMING ROOM 107, NO.8, KANGLE AVENUE, TORCH DEVELOPMENT ZONE, ZHONGSHAN CITY, GUANGDONG PROVINCE,P R 528437
2 JIN CHUNQING ROOM 107, NO.8, KANGLE AVENUE, TORCH DEVELOPMENT ZONE, ZHONGSHAN CITY, GUANGDONG PROVINCE,P R 528437
3 LIU YAN ROOM 107, NO.8, KANGLE AVENUE, TORCH DEVELOPMENT ZONE, ZHONGSHAN CITY, GUANGDONG PROVINCE,P R 528437
PCT International Classification Number A61J1/05
PCT International Application Number PCT/CN2005/001903
PCT International Filing date 2005-11-11
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 200420086385.X 2004-12-16 China
2 200520078247.1 2005-01-17 China
3 200520078680.5 2005-04-27 China