A mixing syringe, set, and method for mixing contents of two material containers

Abstract

A mixing syringe, set and method for mixing contents of two material containers, including a syringe barrel; a sealing member disposed at a distal end of the syringe barrel; a hollow plunger slidably received in the syringe barrel and including: an internal volume dimensioned to receive therein a first and a second material container, and a double-sided penetration member disposed therebetween; a single penetration member protruding from an inner wall at a distal end of the hollow plunger; a one-way valve disposed within a permeable plunger stopper at the distal end of the hollow plunger and in fluid communication with the single penetration member; and a fastening member engageable with a proximal end of the hollow plunger and linearly moveable within the hollow plunger.

Description

APPLICATION FOR PATENTInventor: Shlomo Uri Haimi and Uri Shmuel BarakTitle: A Mixing Syringe, Set, and Method for Mixing Contents of Two Material ContainersFIELD OF THE INVENTION

[0001] This application relates to syringes, including medical syringes. More particularly this application relates to syringes that are used to mix a first material (usually in a liquid state) with a second material (usually in a liquid or solid state) inside the barrel of the syringe where both materials are drawn from their containers placed inside the hollow plunger of the syringe. For example, the syringe can be used to mix drugs with reagents, such as alkalinization of anesthetic drugs by mixing them with sodium bicarbonate (NaHCO3), including for local and regional anesthesia.

[0002] This application also relates to syringes, including medical syringes, that are used to reconstitute a second material (usually in a solid state) with a first material (usually in a liquid state) both materials drawn from their containers placed inside the hollow plunger of the syringe. For example, the syringe can be used to reconstitute lyophilized medication, including emergency drugs, by mixing those medication with a diluent, including saline or water for injection.BACKGROUND OF THE INVENTION

[0003] For various reasons, some materials must be stored and transported apart from their reagents and then, just prior to use, they are mixed with these reagents. Some other materials are provided in a solid state, including in a lyophilized (powdered) state and then, just prior to use, they are reconstituted to a liquid state using a diluent.

[0004] One example for mixing materials with their reagents is liquid state anesthetic drugs, which are sometimes mixed with liquid state sodium bicarbonate (NaHCO3) just prior to injection to patients. One reason for delaying the mixing of anesthetic drugs with their reagents is that such mixing starts the accelerated degradation which shortens the shelf life of the anesthetic drug.

[0005] Anesthetic drugs exert their effect by blocking transmission of the nerve signals in the area of the nerve where the anesthetic drug has been deposited. These drugs are acidified by pharmaceutical manufacturers to acid pH of about 3.5 (equivalent to the pH of lemon juice) to obtain adequate shelf life. This acidic solution is painful to patients when injected for local anesthesia and therefore adds one more reason for patients to resent injections at the dentist or physician office. Inaddition, when the anesthetic drug is injected for regional anesthesia, including nerve block, it does not exert any effect at this low “storage” pH, so both the patient and the dentist / physician must wait several minutes after injection and before the numbness begins, while patient’s body slowly brings the pH level up to that of the body tissues, which is about 7.4.

[0006] Overwhelming evidence demonstrates that raising the pH of the anesthetic drug to a pH closer to neutral just prior to injection, also known as alkalinization and colloquially known as “buffering”, greatly decreases the pain associated with local anesthesia, as well as the latency of the anesthetic effect associated with regional anesthesia, including nerve block. Because of this, many inventors over several decades have attempted to help make buffering a widespread practice in dentistry and dermo-surgery, but at present no method has been satisfactory for several reasons.

[0007] Liquid state Sodium Bicarbonate (NaHCO3) at a concentration of 8.4% is the most common solution used to buffer anesthetics. The NaHCO3 solution and the local anesthetic solution are typically mixed in a ratio of about 9 parts anesthetic drug to 1 part of NaHCO3 solution.

[0008] When physicians, such as dermatologists and plastic surgeons, buffer their anesthetic, they first draw anesthetic solution into their syringe from a vial and then add NaHCO3 solution to the syringe by withdrawing it from a separate vial. This method is uneconomical when using a singledose vial of NaHCO3 solution and compromises aseptic techniques when using a multi-dose vial of NaHCO3 solution. In addition, this method is lengthy and cumbersome. However, despite its disadvantages, many physicians occasionally buffer their anesthetics, as it makes a significant difference in the patient's comfort when performed properly.

[0009] In the oral environment, because of the special need for dexterity, dentists typically inject the anesthetic solution with a reusable hand-held metal syringe, which has evolved and been consolidated into a single design that accounts for almost all syringes in use in dentistry and oral surgery. Nevertheless, this syringe is sometimes used by other physicians as well, including dermatologists and plastic surgeons, mainly for dermo-surgeries. This syringe is used in conjunction with a disposable double-sided injection needle which is attached to the syringe and a specialized glass drug vial called “drug cartridge” or “carpule”, which is filled with anesthetic solution and is placed into the syringe. As the carpule is placed into the syringe it is pierced by the back end of the double-sided needle, so that solution can flow out and through that needle towards the patient. The carpule has a piston that is driven by a pushrod on the syringe, so that when the dentist pushes on the pushrod the piston drives the solution through the attached needle.

[0010] The term carpule, as used herein, mean cartridge. Carpule is a trade name for cartridges (Cook-Waite Laboratories). Some common carpules (cartridges) used by dentists for localanaesthetics contain 2mL or less than 2mL of solution. For example, Articaine (Septocaine®) carpules contain 1.7 ml. Some Carpules contain local anaesthetic, sodium chloride, distilled water and a vasoconstrictor drug with preservative.

[0011] A carpule of 4% Articaine (Septocaine®) by Septodont) contains 40 mg of anaesthetic agent per millilitre which means that each 1.7 ml cartridge contains 72 mg of agent.

[0012] The volume of a carpule is typically less than 2 mL, due mainly to limitations on flow rate through the thin needles that are typically used for local anesthesia (e.g., 30G needles). The use of carpules therefore ensures that the pressure applied on the dental or dermal tissue when giving the injection is not too high and therefore does not cause too much pain to the patient.

[0013] Dentists who buffer their anesthetics typically use one of two commercially available systems. Both systems add considerable time to the procedure. One of these systems does enable dentists to use a disposable syringe. This system, however, requires a bulky countertop device that stores the anesthetic solution in a drug vial rather than in carpules.

[0014] Another system utilizes an injector that introduces NaHCO3 solution into the carpule. This system causes a significant loss of available drug volume in the carpule and breaches the sterile and pharmacological protocol.

[0015] In spite of their disadvantages, both systems have found a limited market, demonstrating that buffering is very desirable from both a dentist and a dental patient perspective. However, making the buffering process less time consuming, less expensive, friendlier, and safer would result in more widespread use for the benefit of both patients and physicians.

[0016] Besides buffering of anesthetics, another application of the syringe under the present invention is for reconstitution of drugs, including lyophilized emergency drugs, which are sometimes provided in their powder state to be reconstituted with a liquid state diluent before they are injected to patients.

[0017] For example, many medical drugs are provided in their lyophilized (powder) state, since lyophilization removes water, preventing hydrolysis and extending drug stability. The improved stability of lyophilized drugs enables their storage at room temperature, which is particularly crucial for emergency drugs carried by non-professional caregivers and even by patients themselves.

[0018] The traditional long and cumbersome reconstitution process, in which diluent is aspirated from one vial, injected to the drug vial for the eventually reconstituted drug to be aspirated and injected into patients is not compatible with emergency injection by non-professional caregivers and by patients themselves.

[0019] Therefore, some emergency drugs are provided in emergency kits that include a drug vial of the lyophilized drug and a prefilled syringe which contains the diluent. One example for such a kit is GlucagenTM Hypokit by Novo Nordisk A / S of Novo Alle 1, 2880 Bagsvaerd Denmark, which is used for the treatment of severe hypoglycemia.

[0020] Since emergency kits are still too cumbersome, manufacturers have developed simpler and more user-friendly auto-injectors for injection of liquid state drugs. These alternatives are more intuitive and faster to use in emergencies without requiring reconstitution. Gvoke HypoPen by Xeris Pharmaceuticals, Inc. of 1375 W Fulton St Suite 1300, Chicago, IL 60607 USA is an autoinjector for the injection of liquid state Glucagon. It simplifies the process of treating severe hypoglycemia, allowing for rapid and straightforward use in emergency situations.

[0021] However, autoinjectors are relatively expensive compared to standard syringes and vials due to several factors associated with their complex engineering, manufacturing, and regulatory compliance.SUMMARY OF THE INVENTION

[0022] It would be preferable to have a system for dentists and physicians, including dermatologists and plastic surgeons, that includes a mixing syringe that is loaded with both a first container, preferably being a carpule, that contains a first material, (such as an anesthetic drug), and a second material container containing a second material (such as a reagent such as NaHCO3 solution), used in the art for alkalinization (colloquially known as buffering) of anesthetic drugs.

[0023] For example, in dentistry and dermo-surgery, having the ability to store both the anesthetic drug and NaHCO3 solution inside a hollow plunger of a mixing syringe and expelling them into the internal volume of the syringe barrel for injecting their mixture to a patient would streamline the buffering process of the anesthetic drug. It is hoped that use of the instant device will result in more widespread use of buffering and therefore in the increase of patient comfort and satisfaction.

[0024] It would also be preferable to have a system not only for physicians and nurses but also for non-professional caregivers, including patients themselves, to use a reconstitution syringe that is loaded with both a first material container, preferably being a carpule, that contains a first material, including a diluent, and a second material container containing a second material, including a lyophilized drug, for injection after it has been reconstituted with the first material, including saline or water for injection.

[0025] There are provided various embodiments of the present invention including a disposable syringe having a hollow plunger, which is suited, inter alia, for mixing drugs with their reagent and for reconstitution of drugs, including lyophilized drugs, using a diluent.

[0026] There is provided a standalone syringe that enables the rapid and simple mixing of medicaments, including anesthetic drugs, with reagents, including liquid state NaHCO3, when both medicament and reagent are stored in their respective containers disposed inside the syringe. There is also provided a standalone reconstitution syringe that enables the rapid and simple reconstitution of medicaments, including lyophilized emergency drugs, with a diluent, including saline or water for injection when both the medicament and diluent are stored in their respective containers disposed inside the syringe.

[0027] There is provided herein a mixing syringe, including: a) a syringe barrel; b) a sealing member disposed at a distal end of the syringe barrel; c) a hollow plunger slidably received in the syringe barrel and including: i) an internal volume dimensioned to receive therein a first material container, a second material container, and a double-sided penetration member disposed therebetween; ii) a single penetration member protruding from an inner wall at a distal end of the hollow plunger; iii) a one-way valve disposed within a permeable plunger stopper at the distal end of the hollow plunger and in fluid communication with the single penetration member; wherein the double-sided penetration member is hollow and has a proximal end positioned to initially not penetrate the first material container, when inserted in the hollow plunger, and a distal end positioned to initially not penetrate the second material container, when inserted in the hollow plunger; and d) a fastening member engageable with a proximal end of the hollow plunger and linearly moveable within the hollow plunger.

[0028] According to further features the first material container containing a first material and the second material container containing a second material are disposed inside the hollow plunger and wherein the mixing syringe has: a resting state wherein the first material container is not penetrated by the proximal end of the double-sided penetration member and the second material container is not penetrated by either the distal end of the double-sided penetration member or the single penetration member; a first penetration state wherein the fastening member is advanced distally such that the first material container is penetrated by the proximal end of the double-sided penetration member; a second penetration state wherein the fastening member is further advanced distally such that the second material container is penetrated by both the distal end of the double-sided penetration member and the single penetration member; an aspiration state wherein the hollow plunger is partially withdrawn from the syringe barrel and a solution, including the first material and the second material, has beenaspirated through the single penetration member, the one-way valve, and the permeable plunger stopper into an internal volume of the syringe barrel defined by internal surfaces of the syringe barrel and an external exposed surface of the permeable plunger stopper; and e) an injection state wherein a needle is attached to the distal end of the syringe barrel, the hollow plunger is pushed towards the distal end of the syringe barrel and a solution, including the first material and the second material, has been injected through the needle to a target.

[0029] According to further features the hollow plunger is prepackaged with the first and the second material containers and the double-sided penetration member. According to further features the fastening member has an external threading which is adapted to be threadably engaged with a matching internal threading of the hollow plunger. According to further features the first material container is insertable into the hollow plunger. According to further features the double-sided penetration member is movably disposed between the first and second portions of the internal volume of the hollow plunger. According to further features a proximal portion of the internal volume of the hollow plunger has dimensions suited to receive therein the first material container which is selected from a group of containers each having a given diameter and a length selected from a range of predefined lengths. According to further features a distal portion of the internal volume of the hollow plunger has dimensions corresponding to dimensions of the second material container.

[0030] According to further features the hollow plunger includes at least one proximal friction protrusion disposed / formed on an internal surface of a chassis retaining the double-sided penetration member, the at least one proximal friction protrusion adapted to retain or restrain the first material container in a state in which the first material container is not penetrated by the proximal end of the double-sided penetration member.

[0031] According to further features the hollow plunger includes at least one distal friction protrusion disposed or formed on an internal surface of a chassis, the at least one distal friction protrusion adapted to retain or restrain the second material container in a state in which the second material container is not penetrated, on a proximal end thereof, by the distal end of the double-sided penetration member, and not penetrated, on a distal end thereof, by the single penetration member.

[0032] According to another embodiment there is provided a multi-use mixing syringe, including: a) the aforementioned syringe barrel; b) the aforementioned sealing member 2; c) the aforementioned hollow plunger; d) a storage rod slidably receivable in the hollow plunger and including: (i) the first material container; (ii) the second material container; (iii) the double-sided penetration member; and (iv) a rod-fastening member engageable at a proximal end of the storage rod and linearly moveable within the storage rod; wherein the storage rod includes an inner threading atan inner surface thereof and an outer threading at an outer surface thereof; wherein the inner threading of the storage rod corresponds to an outer threading of the rod-fastening member; and wherein the outer threading of the storage rod corresponds to an inner threading of the hollow plunger.

[0033] According to further features a proximal portion of the internal volume of the storage rod has dimensions suited to receive therein the first material container selected from a group of containers each having a given diameter and a length selected from a range of predefined lengths. According to further features a distal portion of the internal volume of the storage rod has dimensions corresponding to dimension of the second material container.

[0034] According to further features the double-sided penetration member is movably disposed between the first and second portions of the internal volume of the storage rod. According to further features the storage rod includes at least one proximal friction protrusion disposed or formed on an internal surface of the storage rod, the at least one proximal friction protrusion adapted to retain or restrain the first material container in a state in which the first material container is not penetrated by the proximal end of the double-sided penetration member.

[0035] According to further features the storage rod includes at least one distal friction protrusion disposed / formed on an internal surface of the storage rod, the at least one distal friction protrusion adapted to retain or restrain the second material container in a state in which the second material container is not penetrated, on a proximal end thereof, by the distal end of the double-sided penetration member and not penetrated, on a distal end thereof, by the single penetration member.

[0036] According to further features the rod-fastening / fastening member includes a thumb ring at its proximal end. According to further features the rod-fastening / fastening member includes a ventilation member at a distal end thereof, wherein advancing the fastening member inside the hollow plunger or the rod-fastening member in the storage rod, causes a distal end of the ventilation member to fully penetrate a piston of the first material container and ventilate the first material container through an air inlet at a proximal end of the ventilation member.

[0037] According to further features the rod-fastening / fastening member includes a spring at a proximal end thereof, the spring applying a constant biasing force on a piston of the first material container.

[0038] According to further features the distal end of the syringe barrel is adapted for replaceably receiving thereon a detachable sealing cap and a needle. According to further features the needle is a hypodermic injection needle.

[0039] According to further features the further distal advancement of the fastening member in the second penetration state pushes the first material container onto an internal wall of a chassisretaining the double-sided penetration member and further pushes the second material container distally such that the second material container is penetrated by the single penetration member.

[0040] According to further features the fastening member is further advanced distally in a second penetration state such that the second material container is ruptured by pressure created between the distal end of the double-sided penetration member and the proximal end of the single penetration member.

[0041] According to another embodiment there is provided a mixing syringe set including (a) the aforementioned mixing syringe; (b) the first material container inserted into the hollow plunger, the first material container having a first material disposed therein; (c) the second material container having a second material disposed therein.

[0042] According to another embodiment there is provided a mixing syringe set including (a) the mixing syringe of claim 11 ; and (b) at least one additional storage rod of claim 11.

[0043] According to further features the syringe is adapted to be reused by replacement of the storage rod initially disposed inside the hollowed plunger with the at least one additional storage rod. According to further features the storage rod is provided separately. According to further features the syringe is adapted to be reused by removal of the storage rod and insertion of the additional storage rod. According to further features the first material container is a carpule. According to further features the first material is selected from the group of materials including: a solid, liquid, gas, any intervening state therebetween, and combinations thereof. According to further features the first material is an anesthetic drug and the second material is a buffering or alkalinization solution. According to further features the second material container includes a quantity of the second material sufficient to bring a pH level of the first material disposed in the first container closer to physiological pH level of a patient.

[0044] According to further features the first material is a diluent and the second material is a lyophilized drug. According to further features the first material container includes a quantity of the first material that is sufficient to fully reconstitute the second material disposed in the second material container.

[0045] According to another embodiment there is provided a method for mixing a first material and a second material in a mixing syringe for their injection to a target, the method including the steps of: (a) providing the mixing syringe of claim 2 or the mixing syringe set of claim 26; (b) advancing the fastening member or rod-fastening member such that the mixing syringe goes from the resting state to the first penetration state; (c) advancing the fastening member or rod-fastening member further such that the mixing syringe goes from the first penetration state to the second penetration state; (d) partially withdrawing the hollow plunger from the syringe barrel creating a vacuum in thesyringe barrel such that the mixing syringe progresses from the second penetration state to the aspiration state; and (e) pushing the hollow plunger such that the mixing syringe progresses from the aspiration state to the injection state.

[0046] According to further features the method further includes (f) replacing the storage rod with an additional storage rod; and (g) repeating steps (b) to (e) for as many injections required to the same target.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] FIG. 1 is a side elevation of a conventional prior art dental syringe apparatus, also known as aspirating syringe, connected to a prior art double-sided needle, both replaced by the present invention, used in combination with a carpule;

[0048] FIG. 2 is an exploded sectional view, broken away, of the prior art conventional dental syringe apparatus, also known as aspirating syringe, and the double-sided needle of FIG. 1, both replaced by the present invention;

[0049] FIG. 3 is a perspective view of a carpule;

[0050] FIG. 4A is a cross-sectional view of one embodiment of the second material container according to the teachings of the present invention;

[0051] FIG. 4B is an upper view of the second material container depicted in FIG 4A;

[0052] FIG. 4C is a cross-sectional schematic view of another embodiment of the second material container to be used specifically in the fourth preferred embodiment of the present invention;

[0053] FIG. 5A is a cross-sectional view of a first preferred embodiment of a mixing / reconstitution syringe of the present invention, provided with a double penetration member disposed inside its hollow plunger, the double penetration member still not being in physical interaction with neither the carpule, nor the second material container;

[0054] FIG. 5B is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 4A in a state after the fastening member is screwed to such length that pushes the carpule, to be fully penetrated by the proximal end of the double penetration member;

[0055] FIGS. 5C1 and 5C2 are cross sectional views of the mixing / reconstitution syringe depicted in FIG 4B in a state after the fastening member is further screwed to such length that pushes the carpule, to advance the double penetration member along the hollow plunger until the second material container is fully penetrated by both the single penetration member and the double penetration member;

[0056] FIGS. 5D1 and 5D2 are cross sectional views of the mixing / reconstitution syringe depicted in FIG 5C in a state after the hollow plunger is pulled out of the syringe barrel to a length that causes the vacuum created inside the internal volume of the syringe barrel to aspirate the entire volume of the first material and that of the second material from their respective containers into that internal volume of the syringe barrel;

[0057] FIG. 5E is a cross-sectional view of the mixing / reconstitution syringe depicted in FIGS 5D1 and 5D2 in a state after the sealing cap is disassembled from the distal end of the syringe and replaced by a needle;

[0058] FIG. 6A is a cross-sectional view of a second and a third preferred embodiments to the mixing / reconstitution syringe of the present invention, provided with a storage rod disposed inside its hollow plunger, the storage rod containing both the carpule and the second material container;

[0059] FIG. 6B 1 is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 6A in a state after the fastening member is screwed to such length that advances the carpule, to be fully penetrated by the double penetration member;

[0060] FIG. 6B2 is a cross-sectional zoom-in view of the interaction between the hollow plunger, the storage rod, the carpule and the fastening member of the mixing / reconstitution syringe in the state depicted in FIG 6B 1 ;

[0061] FIG. 6C1 is a cross-sectional view of the mixing / reconstitution syringe depicted in FIGS 6B 1 and 6B2 in a state after the fastening member is further screwed to advance the storage rod inside the hollow plunger until the second material container is fully penetrated by both the single penetration member and the double penetration member;

[0062] FIG. 6C2 is a cross-sectional zoom-in view of the interaction between the hollow plunger, the storage rod, the carpule and the fastening member of the mixing / reconstitution syringe in the state depicted in FIG 6C1;

[0063] FIG. 6D is a cross-sectional view of the mixing / reconstitution syringe depicted in FIGS 6C1 and 6C2 in a state after the hollow plunger is pulled out of the syringe barrel to a length that causes the vacuum created inside the internal volume of the syringe barrel to aspirate the entire volume of the first material and that of the second material from their respective containers into that internal volume of the syringe barrel;

[0064] FIG. 6E is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 6D in a state after the sealing cap is disassembled from the distal end of the syringe and replaced by a needle;

[0065] FIG. 7A is a cross-sectional view of a first sub-assembly to the mixing / reconstitution syringe according to either the second or the third preferred embodiments to the present invention, including a syringe barrel, a sealing cap, a hollow plunger, a plunger stopper and a one-way valve.

[0066] FIG. 7B is a cross-sectional view of a second sub-assembly to the mixing / reconstitution syringe according to either the second or the third preferred embodiments to the present invention including a storage rod, a carpule, a second material container and a fastening member.

[0067] FIG. 8A is a cross-sectional view of a fourth preferred embodiment to a mixing / reconstitution syringe of the present invention, provided with a penetration-puncturing member disposed inside its hollow plunger;

[0068] FIG. 8B is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 7 A in a state after the fastening member is screwed to such length inside the hollow plunger that pushes the carpule to be fully penetrated by the penetration-puncturing member;

[0069] FIG. 8C is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 7B in a state after the fastening member is further screwed by the user of the mixing / reconstitution syringe to such length that advances the carpule to push the penetration-puncturing member along the hollow plunger until the second material container is fully punctured by both the penetrationpuncturing member and the single puncturing member;

[0070] FIG. 8D is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 8C in a state after the hollow plunger is pulled out of the syringe barrel to a length that causes the vacuum created inside the internal volume of the syringe barrel to aspirate the entire volume of the first material and that of the second material from their respective containers into that internal volume of the syringe barrel;

[0071] FIG. 8E is a cross-sectional view of the mixing / reconstitution syringe depicted in FIG 8D in a state after the sealing cap is disassembled from the distal end of the syringe and replaced by a needle;DESCRIPTION OF THE INVENTION

[0072] The principles and operation of a mixing / reconstitution syringe adapted for the mixing / reconstitution of materials before their injection according to the present invention, may be better understood with reference to the drawings and the accompanying description. In embodiments, the mixing syringe may be used for the buffering of anesthetic drugs by mixing them with NaHCO3 solution and / or for reconstitution of lyophilized drugs with their diluents.

[0073] Now referring to the drawings, a conventional prior art syringe / needle apparatus is illustrated in Figures 1 and 2, while a carpule is illustrated in Figure 3. The prior art syringe / needle apparatus of Figs. 1 and 2 is suitable for use in conjunction with the carpule of Fig. 3.

[0074] Referring hereafter to the various embodiments of the present invention, there are provided the following components that are included in one or more embodiments, mutatis mutandis. The hollow plunger includes a first material container, preferably being a carpule that contains a first material, including anesthetic drug or diluent. In embodiments, that carpule is disposed directly inside the hollow plunger and in other embodiments it is disposed inside a storage rod contained in that hollow plunger.

[0075] Throughout the present document, the material initially disposed inside the first material container is referred to as a ‘first material’, ‘anesthetic drug’ or ‘diluent’. However, for the sake of convenience and clarity, this material may alternatively be referred to as a ‘first liquid’, ‘anesthetic’, ‘diluent’ and variations thereof. It is made clear that any use of a specific material such as ‘anesthetic’ or ‘diluent’ is merely an example and in no way intended to limit the scope of the invention. Accordingly, any mention of a specific type of material as opposed to the wider term ‘first material’ is to be understood meaning “a first material, such as a liquid”, “a first material, such as medicament”, etc.

[0076] To be clear, the term ‘first material’ includes a solid, liquid, gas, any intervening state therebetween, and / or combinations thereof. For example, the material may refer to a gas, a liquid, a liquid with solid / insoluble particles disposed therein, a gel, a gel with solid / insoluble particles disposed therein, solid particles such as powder, and any combination thereof.

[0077] The hollow plunger of the syringe further includes a second material container, the second material container preferably containing a second material, including either NaHCO3 solution or lyophilized drug. In embodiments, the second material container is disposed inside the hollow plunger and in other embodiments it is disposed inside a storage rod contained in that hollow plunger.

[0078] Throughout the present document, the material initially disposed in the second material container is referred to as a ‘second material’, ‘drug’ ‘emergency drug’ or a ‘reagent’. However, for the sake of convenience and clarity, this material may alternatively be referred to as a ‘reagent’, ‘NaHCO3’, ‘NaHCO3 solution’, ‘lyophilized drug’, ‘powder state drug’, ‘emergency drug’ and variations thereof. It is made clear that any use of a specific material such as ‘reagent’ or ‘lyophilized drug’ is merely an example and by no way intended to limit the scope of the present invention. Accordingly, as mention of a specific type of material as opposed to the wider term ‘second material’is to be understood meaning “a second material, such as a lyophilized drug”, “a second material, such as reagent”, “a second material, such as NaHC03 solution”, etc.

[0079] To be clear, the term ‘second material’ includes a solid, liquid, gas, any intervening state therebetween, and / or combinations thereof. For example, the material may refer to a gas, a liquid, a liquid with solid / insoluble particles disposed therein, a gel, a gel with solid / insoluble particles disposed therein, solid particles such as powder, and any combination thereof. In embodiments, the volume of the second material stored inside the second material container is the volume required for the desired interaction with the entire volume of first material stored inside the first material container. For example, a solid state second material, including a lyophilized drug, is reconstituted with a liquid state first material, including diluent for lyophilized drugs, either before they are aspirated into the internal volume of the syringe barrel or after they are already aspirated.

[0080] In embodiments, the syringe also includes a double-sided penetration / puncturing / rupturing member disposed inside the hollow plunger between the first material container and the second material container. In embodiments, the double penetration / puncturing member is disposed directly inside the hollow plunger and in other embodiments it is disposed inside a storage rod contained in that hollow plunger.

[0081] In embodiments, the hollow plunger and the storage rod are in shape and form that protect both the first material container and the second material container from inadvertent damage or emptying.

[0082] The syringe also includes a fastening member at its proximal end. In embodiments, the fastening member is adapted to be inserted in the open proximal end of the hollow plunger so as to enclose the first material container inside the hollow plunger and is further adapted to linearly move the first material container from its initial position inside the hollow plunger towards the double-sided penetration / puncturing member. In other embodiments, the fastening member, referred to as a rodfastening member, is adapted to be inserted in the open proximal end of the storage rod so as to enclose the first material container inside the storage rod and is further adapted to advance that first material container from its initial position towards the double-sided penetration / puncturing member.

[0083] The syringe also includes a plunger stopper attached to the outer side of the hollow plunger at its distal end. According to further features, the plunger stopper is permeable and provides a fluid path between the internal volume of the hollow plunger and the internal volume of the syringe barrel. According to still further features the fluid path is unidirectional. According to still further features the unidirectional fluid path is afforded by a one-way valve, also known as a check valve.

[0084] DU 020.001 SD by Minivalve International B.V. of Liibeckstraat 21, 7575 EE Oldenzaal, the Nederlands - is a Duck Bill one-way valve which may be integrated in accordance with one example embodiment of the present invention to the plunger stopper and thereby prevent materials, including the said first material, second material and their mixture / reconstitution, once drawn to the internal volume of the syringe barrel, from returning back into the internal volume of the hollow plunger.

[0085] It should be understood that any method known in the art for advancing the fastening member, the first material container, and the double-sided penetration / puncturing member, either simultaneously or sequentially, along the hollow plunger or along the storage rod (as the case may be) is considered within the scope of the present invention, including by turning and by pushing the fastening member inside the hollow plunger / storage rod.

[0086] In embodiments of the present invention, it replaces multi-use and metal aspirating syringes. According to features of the present invention, the syringe is a disposable syringe. It should be understood that in both these conventional aspirating syringes, as well as in embodiments of the present invention in which the first material container is a carpule, the septum of the carpule is penetrated, including by a needle or a spike, through which the first material, including either anesthetic drug or diluent for lyophilized drugs, is expelled to a target, including patient’s body. However, while most conventional aspirating syringes include harpoons or similar setting to push the piston of the carpule for injecting its liquid content to a patient, in embodiments of the present invention the carpule piston is not pushed but rather pulled together with the liquid content of that carpule by the vacuum generated inside the syringe, as further explained herein.

[0087] In an example embodiment of the present invention, the syringe includes a cap adapted to be attached to the distal end of the syringe barrel to prevent the ingress of materials, including atmospheric air, to the syringe barrel from that distal end so as that upon pulling the hollow plunger from the syringe barrel, the aforementioned vacuum is generated inside the internal volume of the syringe barrel and draws both the first material and the second material from their respective containers into the headspace at the internal volume of the syringe barrel for the eventual injection into a target. In embodiments, at least one additional O-ring is used for ensuring an airtight seal.

[0088] In a first (Figs. 5A-5E), a second (Figs. 6A-6E) and a third (Figs. 7A-7B) example embodiments of the present invention, the second material container is penetrated by at least two penetration members from at least two directions, while in the fourth example embodiment (Figs. 8A- 8E) the second material container is not penetrated but rather punctured or ruptured by at least two puncturing members that squeeze that second material container from at least two opposing directions.

[0089] In the second and third embodiments the syringe also includes the storage rod disposed inside the hollow plunger. The storage rod contains the first and second material containers and the double-sided penetration member. In embodiments, the proximal end of fastening or rod-fastening member includes a thumb ring for performing aspiration tests known in the art.

[0090] In embodiments, the presented devices replace emergency kits for injections of emergency drugs; lower the cost to users of those kits; reduce the time for non-clinically professional individuals to inject emergency drugs; increase the shelf life of emergency medications by using them in a solid state rather than in liquid state and; encourage patients to carry lightweight and low volume emergency kits with them.

[0091] Once again referring to the Figures, Figure 4A depicts a cross-sectional view of an example embodiment of a second material container 150 according to the present invention. The second material container 150 is adapted to be filled with a second material 151, which in some embodiments is NaHCO3 solution and in other embodiments is a lyophilized drug. In yet other embodiments, the second material may be some other liquid, gas, or solid material. In one embodiment of the present invention a body 152 of the second material container 150 is made of materials known in the art for drug containers, including glass.

[0092] In one embodiment of the present invention, each of the two openings 153 of the second material container 150 is sealed by the at least one external membrane 154, including a polyisoprene layer. In preferred embodiment of the present invention, the second material container 150 also includes at least one internal member / membrane 155, including a halobutyl layer. In embodiments, the at least one of the external membrane 154 and the at least one internal membrane 155 seal the openings 153 of the second material container 150 when tightened to the body 152 of that second material container 150, preferably by aluminum sheets 156 crimped onto that body 152 using crimping methods known in the art.

[0093] FIG 4B depicts a top-down view of the second material container 150 depicted in FIG 4A. An upper aluminum sheet 156 depicted in FIG 4B, as well as a corresponding, lower aluminum sheet 156 at the opposite side of the second material container 150 are perforated so as to expose the outer sides of the external membranes 154, thereby enabling penetration of a needle or a spike through that outer side to an inner space of that second material container in order to enable the flow of the first material into the second material container 150 and the flow of a mixture or reconstituted solution of the first material together with the second material to flow from the second material container 150 to an internal space 112 (see for example Figs. 5D1 and 5D2) of a syringe barrel 110 (see for example Figs. 5D1 and 5D2) in accordance with the teachings of the present invention, as discussed herein .

[0094] One skilled in the art would appreciate that under the preferred embodiment disclosed herein the top end of the second material container 150 as depicted in FIG 4B, as well as the opposite, bottom end of that second material container 150, is not substantially different from the ends of standard carpules, as depicted in FIG 3. One skilled in the art would appreciate, however, that while the content of a standard carpule flows therefrom using a mechanical force applied on a piston (not shown) that pushes the content of the carpule therefrom, the content of the second material container 150 does not flow therefrom other than through vacuum forces according to the teachings of the present invention.

[0095] Figure 4C depicts a cross-sectional view of another example embodiment of a second material capsule 310 according to the teachings of a fourth preferred embodiment of the present invention (depicted in Figs. 8A-8D). The second material capsule 310 is adapted to be filled with the second material 151 (which, for example, in some embodiments is NaHCO3 solution and in other embodiments is a lyophilized drug). In one embodiment of the present invention a body 310A of the second material capsule 310 is made of materials known in the art for drug containers, including butyl rubber. In one embodiment of the present invention, the second material capsule 310 is made from a material that is adapted to rupture under pressure, as per the teachings of the fourth preferred embodiment of the present invention discussed elsewhere herein. In one preferred embodiment, the second material capsule 310 includes margins 311 which are used to hang the second material capsule 310 on opposing surfaces before the capsule is squeezed in accordance with the teachings of the fourth preferred embodiment.

[0096] Figure 5A depicts a cross-sectional view of a first example embodiment of a mixing / reconstitution syringe 100 according to the instant invention. The mixing / reconstitution syringe 100 consists of a syringe barrel 110. In an example embodiment, a sealing member such as sealing cap 190 is attached to a distal end of the syringe barrel 110 by a standard slip fitting. In another example embodiment, the sealing cap 190 is attached to the distal end of the syringe barrel 110 by a standard Luer lock fitting (not shown). It should be understood, however, that the term sealing member comes to include any type of fitting that seals the syringe barrel.

[0097] The mixing / reconstitution syringe 100 further consists of a hollow plunger 120. In one example embodiment of the present invention, a single-sided penetration member or simply a single penetration member 121 protrudes from an inner wall at the distal end of the hollow plunger 120. In an example embodiment, the single penetration member 121 is a spike that protrudes from that distal end. In embodiments, the spike 121 is a hollow spike or needle for penetrating the second material container. The single penetration member 121 is in fluid communication with a one-wayvalve 171 which is disposed in a permeable plunger stopper 170. The one-way valve and plunger stopper are detailed elsewhere herein.

[0098] The hollow plunger 120 includes an internal volume that is dimensioned, or has dimensions appropriate to receive within the internal volume a first material container 140, a second material container 150, and a double-sided penetration member 130 disposed between the first and second material containers. The example first material container depicted in the figure is a carpule 140. The double-sided penetration member 130 is hollow. The double-sided penetration member is sometimes referred to simply as a double penetration member. A fastening member 160 is engageable with an open, proximal end of the hollow plunger. The fastening member 160 is linearly moveable within the internal volume of the hollow plunger.

[0099] The first material container 140 contains a first material 141, such as, for example, an anesthetic drug, a diluent for lyophilized drugs, and / or some other liquid, gas, or solid material.[000100] In embodiments, at least one carpule or proximal friction protrusion 125 is disposed or formed on an inner surface of a double penetration chassis 133 mechanically restrains or retains the first material container 140 in a predetermined position or state inside that hollow plunger 120. The double-sided penetration member 130 is disposed in the chassis 133. It should be understood, however, that any method or mechanism for retaining the first material container 140 in a state in which the first material container is not penetrated by a proximal end or tip 130 A of the double-sided penetration member 130 is within the scope of the present invention. In some embodiments, the double penetration chassis 133 is attached to a collar of the first material container 140.[000101] The internal volume of the hollow plunger 120 is further dimensioned to contain a second material container 150, containing a second material 151. In some embodiments the second material is a reagent, such as a liquid state NaHCO3 solution, known as a buffering solution to anesthetic. In other embodiments, the second material is a diluent for lyophilized drugs.[000102] In embodiments, at least one distal friction protrusion 126 is disposed or formed on an inner surface of the double penetration chassis 133 and is adapted to mechanically retain the second material container 150 in a predetermined position or state inside that double penetration chassis 133. It should be understood however that any method for retaining the second material container 150 in a state in which that second material container 150 is not penetrated by a distal end or tip 130B of the double-sided penetration member 130 nor by a proximal end 121A of the single penetration member 121 is within the scope of the present invention. The double-sided penetration member and the single penetration member are both hollow.Y1[000103] It should be understood that both the first material container 140, preferably being a carpule, and the second material container 150 in their respective states shown in Fig. 5 A are still not engaged with the single penetration member 121 nor the double-sided penetration member 130. This state is also referred to herein as a ‘resting state’.[000104] Figure 5B depicts a cross sectional view of the first example embodiment to the mixing / reconstitution syringe 100 according to the instant invention, in a ‘first penetration state’ after the fastening member 160 has been linearly progressed deeper inside the hollow plunger 120. The aforementioned movement of the fastening member causes a wall 161 at the distal end of the fastening member 160 to push the first material container 140 towards the distal end of the plunger by a force that overcomes the interfering geometry of the at least one proximal friction protrusion 125 thereby advancing the first material container 140 towards the double-sided penetration member 130 until a septum / diaphram 142 of the first material container 140 is penetrated by the proximal tip 130 A of the double penetration member 130. In example embodiments, the double-sided penetration member 130 is a double-sided needle. In embodiments where the fastening member 160 is threadably engaged with the proximal end of the hollow plunger, the fastening member is moved linearly by twisting, rotating, or turning the member to be screwed deeper into the internal volume of the hollow plunger.[000105] Figure 5C1 depicts a cross sectional view of a first embodiment to the mixing / reconstitution syringe 100 according to the instant invention, in a ‘second penetration state’ after the fastening member 160 is further linearly progressed within the internal volume of the hollow plunger (e.g., twisted / rotated / turned). This movement further pushes the first material container 140against the double penetration chassis 133 such that the chassis overcomes the interfering geometry of at least one chassis friction protrusion 127 (see Fig. 5A)and moves a sufficient length along the hollow plunger 120 so as to cause the second material container 150 to be fully penetrated by both the distal tip 130B of that double-sided penetration member 130 (on one end) and the proximal end 121 A of the single penetration member 121 (on the other end). It should be understood however that any earlier penetration by either that double-sided penetration member 130 or the single penetration member 121 into the second material container 150 is within the scope of the present invention. That is to say that the first penetration state and the second penetrate state may be achieved simultaneously or at least one state may overlap with the other state.[000106] In an example embodiment, the aggregate advancement along the internal volume of the hollow plunger 120 of the fastening member 160, of the first material container 140, preferably being a carpule, of the double-sided penetration member 130 and of the second material container 150 is preferably in correlation with the aggregate length required for the single penetration member 121to penetrate the second material container 150 from the distal side 150B of that second material container 150, for the distal tip 130B of the double-sided penetration member 130 to penetrate that second material container 150 from its proximal end 150A and for the proximal end or tip 130A of the double penetration member 130 to penetrate the septum / diaphragm 142 of the first material container 140, preferably being a carpule.[000107] In an example embodiment, it is intended that at least one of a visual signal, an audible signal or a haptic signal is activated to indicate that the double penetration member 130 has reached a certain location along the hollow plunger 120 so that a continuous fluid path is formed, starting at the first material container 140, continuing through the hollow body of the double-sided penetration member 130, the second material container 150, the hollow single penetration member 121, the oneway valve 171, and the permeable plunger stopper 170 and ending at the internal volume 112 (best shown in Figs. 5D1 and 5D2) of the syringe barrel 110.[000108] Figure 5C2 depicts a cross-sectional view of a first preferred embodiment of the mixing / reconstitution syringe 100, substantially as depicted in FIG 5C1, except that it includes a biasing member 168 instead of a ventilation member 164.[000109] Figure 5D1 depicts a cross-sectional view of the first example embodiment of the mixing / reconstitution syringe 100 according to the instant invention in a state referred to herein as ‘an aspiration state’ whereby the hollow plunger 120 has been partially withdrawn from / pulled out of the syringe barrel 110. The sealing cap 190 at the distal end of the syringe barrel 110 does not allow the ingress of materials, including atmospheric air (not shown), from that distal end into the internal volume 112 of the syringe barrel 110 resulting in the generation of vacuum inside that internal volume 112 upon withdrawing the hollow plunger 120 from the syringe barrel 110. As a result, a solution 113 is aspirated into the internal volume of the syringe barrel. This result occurs by the vacuum aspirating the first material 141 (shown in figure 5C), e.g., including either anesthetic drug or diluent for lyophilized drugs, through the above-mentioned fluid path ending at the internal space 112 of the syringe barrel 110. In parallel, the same vacuum also aspirates the second material 151 (e.g., NaHCO3 solution or lyophilized drug), from the second material container 150, through the single penetration member 121, the plunger stopper 170 and the one-way valve 171 to the same internal space 112 of that syringe barrel 110. The two materials may, for example, mix on their way to internal space, forming a single solution 113.[000110] It should be understood that the term sealing cap is provided herein for illustration purposes only and may include a detachable sealing cap 190 as depicted in FIG 5D1 and / or a one-way valve that enables the flow of materials in one way only and forms an integral part of the syringebarrel 110. A one-way valve enables a user (not shown) of the mixing / reconstitution syringe 100 to pull the hollow plunger 120 from the syringe barrel 110 regardless of whether a needle 191, such as a hypodermic injection needle, is already attached to the distal end of the syringe barrel 110 or whether it is necessary to first detach a detachable sealing cap and only then to attach that needle 191. It should be understood that any method used for preventing the ingress of air (not shown) from the distal end of the syringe barrel 110 is within the scope of the present invention.[000111] In embodiments, at least one O-ring 132 disposed between an outer surface of the double penetration chassis 133 and an inner surface at the hollow plunger 120 is also used to ensure the generation of that vacuum.[000112] One skilled in the art would appreciate that the one-way valve 171 disposed at the plunger stopper 170 prevents materials, including the first material 141, the second material 151 and their mixed state solution 113 from returning back into the internal volume of the hollow plunger 120 once aspirated by said vacuum into the internal space 112 of the syringe barrel 110 and after the user (not shown) of the mixing / reconstitution syringe 100 no longer holds the hollow plunger 120. It should be understood that the terms one-way valve and check valve are provided herein for illustration purposes only and that any method known in the art for preventing bi-directional flow of materials, including the mixture thereof, is within the scope of the present invention.[000113] It is well known in the art that pulling syringe plungers out of syringe barrels does not require extensive physical force and that medicaments flow from drug containers to the inner space of those syringe barrels relatively fast. One skilled in the art would appreciate, however, that pulling the hollow plunger 120 out of the syringe barrel 110, as depicted in FIG 5D1, would create a vacuum inside the first material container 140 thereby drawing both the first material 141 (e.g., shown in FIG 5C1), as well as the carpule piston 143 towards the septum / diaphragm 142 of that first material container 140. While the first material 141 is drawn at a relatively low resistance, the carpule piston 143, which is tightly pressed to the inner walls of that carpule 140, is drawn at a relatively high friction that requires the user (not shown) of the mixing / reconstitution syringe 100 to use a relatively powerful pulling force to pull the hollow plunger 120 out of that syringe barrel 110 in order to overcome that relatively high friction. In some embodiments of the present invention however, the carpule piston 143 is prevented from being pulled together with the first material 141 upon the generation of said vacuum, through ventilation by surrounding ambient air (not shown) that enters the first material container 140 so that no vacuum / suction force is applied on the carpule piston 143 and therefore a relatively small force is required for pulling the hollow plunger 120 out of the syringe barrel 110.[000114] In embodiments, the fastening member 160 includes a ventilation member 164 at the distal end of that fastening member 160 whereby twisting / rotating / turning the fastening member 160 results in screwing the fastening member deeper inside the hollow plunger 120 (as depicted in FIG 5B) or further twisting / rotating / turning it (as depicted in FIG 5C1) will cause the distal end 165 of the ventilation member 164 to fully penetrate the carpule piston 143, thereby ventilating the inner space 144 (shown in FIG 5D1) of the first material container 140 by suction of ambient / atmospheric air into that first material container 140 through the air inlet 166 at the proximal end of the ventilation member 164. In embodiments, the ventilation member 164 also includes an air filter 167, preventing the ingress of unwanted material, including pathogens, into the first material container 140. It should be understood, however, that any method for ventilation of the first material container 140 is within the scope of the present invention. It should also be understood that pulling the first material 141 together with the carpule piston 143 without any ventilation is within the scope of the present invention.[000115] Figure 5D2 depicts a cross-sectional view of a second example embodiment of the mixing / reconstitution syringe 100 according to the instant invention in the aspiration state after the hollow plunger 120 has been partially withdrawn from of the syringe barrel 110, substantially as depicted in FIG 5D1.[000116] One skilled in the art would appreciate that the mixing / reconstitution syringe 100 depicted in FIG 5D2 does not include a ventilation member 164 of the sort depicted in FIG 5D1 but rather a biasing member 168. The biasing member 168, preferably a spring, exerts force on the proximal side of the carpule piston 143, thereby enabling the user (not shown) of the mixing / reconstitution syringe 100 to use relatively less force to aspirate both the first material 141 and move the carpule piston 143 towards the capsule septum 142 when that user (not shown) of that mixing / reconstitution syringe 100 pulls the hollow plunger 120 out of the syringe barrel 110 overcoming the relatively high friction between the inner walls of the carpule 140 and that piston 143 of that carpule 140. One skilled in the art would appreciate that the pressure member 168 exserts a force on the carpule piston 143 in the same direction as the suction force created by the vacuum generated inside the carpule 140 when pulling the hollow plunger 120 out of the syringe barrel 110. In one embodiment of the present invention, the pressure member 168 continuously generates pressure upon the proximal side of the carpule piston 143. In another preferred embodiment, the pressure member 168 does not apply pressure on that proximal side of the carpule piston 143 before the carpule septum 142 is penetrated by the proximal end 130A of the double penetration member 130. It should also be understood that pulling the first material 141 together with the carpule piston 143 without the aid ofany additional force beyond the vacuum force generated inside the mixing / reconstitution syringe 100 is within the scope of the present invention.[000117] FIG. 5E is a cross sectional view of the mixing / reconstitution syringe 100 depicted in FIGS 5D1 or 5D2 in a state after the sealing cap 190 (shown in FIGS 5D1 and 5D2) is disassembled from the distal end of the syringe 100 and replaced by a needle 191. Preferably the needle is a hypodermic injection needle, that is required for proceeding with medical preparations known in the art. Examples of procedures include removal of air bubbles from the internal volume 112 of the syringe barrel 110 and, specifically for local or regional anesthesia, performing aspiration tests known in the art before the eventual injection to a target, including a patient’s body.[000118] A mixing syringe set may include the aforementioned syringe barrel, hollow plunger etc., first material container inserted in the hollow plunger (prepackaged inside the hollow plunger or provided separately) and a second material container having a second material disposed therein.[000119] Figure 6A depicts a cross-sectional view of a second embodiment or a third preferred embodiment of a mixing / reconstitution syringe 200 according to the instant invention. The depicted embodiment has a similar syringe barrel, sealing member, and hollow plunger as the mixing syringe 100 detailed above. The same or similar parts have the same reference labels. In embodiments, the mixing syringe 200 is a multi-use syringe. The example embodiment of mixing / reconstitution syringe 200 includes a hollow plunger 120 and a single penetration member 121 protruding from the inner side of a wall at the distal end of that hollow plunger 120. The mixing / reconstitution syringe 200 also includes a storage rod 180 removably or non -removably disposed inside that hollow plunger 120. [000120] The storage rod 180 includes a double-sided penetration member 130, preferably a hollow double-sided needle. The storage rod 180 includes an internal volume. The internal volume includes a proximal portion 138 having dimensions suited to receive therein (possibly even at a manufacturing stage) a first material container 140. The first material container is selected from a group of containers each having a given diameter and a length selected from a range of predefined lengths. In embodiments, the first material container is a carpule. The first material container 140 contains a first material 141, including, for example, an anesthetic drug, a diluent for lyophilized drugs, or another liquid, solid, or gas.[000121] In embodiments, the at least one proximal friction protrusion 125 disposed or formed on an inner surface of the storage rod 180 mechanically retains the first material container 140 in a predetermined position inside that storage rod 180. It should be understood however, that any method for retaining that first material container 140 in a state that it is not penetrated by the proximal end 130A of the double-sided penetration member 130 is within the scope of the present invention.[000122] The storage rod 180 also includes at least one second material recess 139 in a distal portion of the internal volume of the storage rod. The second material container 150 is disposed in the distal portion. The second material container 150 contains a second material 151, such as, for example, liquid NaHCO3 solution, lyophilized drug, and / or some other liquid, solid, or gas.[000123] In embodiments, a distal friction protrusion 126 mechanically retains the second material container 150 inside the second material recess 139 of the storage rod 180. It should be understood however, that any method for retaining the second material container 150 in a state in which that second material container 150 is not penetrated by either the distal end 130B of the doublesided penetration member 130 or the proximal end 121 A of the single penetration member 121 is within the scope of the present invention.[000124] In one example embodiment of the present invention, the hollow plunger 120 includes inner threading 124 at an inner surface of that hollow plunger 120. In one example embodiment of the present invention, the storage rod 180 includes both an inner threading 183 at an inner surface of that storage rod 180 and an outer threading 184 at an outer surface of that storage rod 180.[000125] In one example embodiment of the present invention, a rod-fastening member 160 includes an outer threading 162 at an outer surface of that fastening member 160. In the depicted example embodiment, the outer threading 184 of the storage rod 180 corresponds to the inner threading 124 of the hollow plunger 120. In the depicted example embodiment, the inner threading 183 of the storage rod 180 corresponds to the outer threading 162 of the rod-fastening member 160.[000126] It should be understood that both the first material container 140, preferably being a carpule, and the second material container 150 in their states as shown in FIG 6A are still not physically engaged with either the single penetration member 121 or the double-sided penetration member 130.[000127] Figures 6B1 and 6B2 depict cross sectional views of a second and a third preferred embodiments to the mixing / reconstitution syringe 200 according to the instant invention, in a state after the rod-fastening member 160 is advanced (e.g., twisted / rotated / turned) inside the storage rod 180 causing the distal end of that rod-fastening member 160 to push the first material container 140, preferably being a carpule, to be advanced inside that storage rod 180 towards the double-sided penetration member 130.[000128] To affect the first penetration state depicted in FIGS. 6B1 and 6B2, the user (not shown) of the mixing / reconstitution syringe 200 twists / rotates / turns the fastening member 160. Consequently, the first material container 140, preferably being a carpule, is advanced along the storage rod 180 until the septum 142 of that first material container 140 is penetrated by the proximalend 130A of the double-sided penetration member 130, preferably being a double-sided hollow needle or spike.[000129] The advancement of the first material container 140 along the internal volume of the storage rod 180 corresponds to the length of the inner threading 183 of the storage rod 180 preferably set in correlation with the length required for the septum 142 of the first material container 140 to be penetrated by the proximal end 130A of the double-sided penetration member 130.[000130] In an example embodiment, at least one of the storage rod 180 or the rod-fastening member 160 includes a mechanism or a ratchet with which the fastening member 160 may be pushed linearly (rather than screwed) into the storage rod 180 by the user (not shown) of the mixing / reconstitution syringe 200, to enable the use of only one hand of that user for advancing that fastening member 160 inside that storage rod 180.[000131] Figures 6C1 and 6C2 depict cross sectional views of a second or a third preferred embodiment of the mixing / reconstitution syringe 200 according to the instant invention, in a second penetration state after the rod-fastening member 160 is further twisted / rotated / turned or otherwise manipulated to advance the storage rod 180 to a degree that the second material container 150 is fully penetrated by both the proximal end 121 A of the single penetration member 121 and the distal end 130B of the double penetration member 130.[000132] As depicted in FIG 6C2, advancing the storage rod 180 towards the distal end of the hollow plunger 120 is affected by the user (not shown) of the mixing / reconstitution syringe 200 continuing to twist / rotate / turn or otherwise advance the rod-fastening member 160 even after the distal end 162B of the threading 162 at the outer surface of the fastening member 160 reaches the distal end 183B of the inner threading 183 at the storage rod 180, thereby engaging the outer threading 184 at the storage rod 180 with the inner threading 124 at the hollow plunger 120.[000133] In embodiments, both the proximal end 150A and the distal end 150B of the second material container 150 are penetrated simultaneously by both the distal end 130B of the double-sided penetration member 130 and the proximal end 121 A of the single penetration member 121, respectively. In other embodiments, the distal end 130B of that double-sided penetration member 130 first penetrates the proximal end 150A of the second material container 150 and only then does the proximal end 121 A of that single penetration member 121 penetrate the distal end 150B of the doublesided penetration member. In yet other embodiments, the proximal end 121 A of that single penetration member 121 first penetrates the distal end 150B of the second material container 150 and only then does the distal end 130B of that double-sided penetration member 130 penetrate the proximal end 150A of the second material container 150.[000134] In embodiments, the advancement of the storage rod 180 along the hollow plunger 120 corresponds to the length of the inner threading 124 at the hollow plunger 120 so as that this advancement is set in correlation with the length required for both the single penetration member 121 to penetrate the second material container 150 from the distal end 150B of that second material container 150 and for the distal end 130B of the double-sided penetration member 130 to penetrate the second material container 150 from its proximal end 150A.[000135] In an example embodiment, it is intended that at least one of a visual signal, an audible signal, and / or a haptic signal is activated to indicate that the proximal end of the storage rod 180 has reached a certain location along the hollow plunger 120 such that a continuous fluid path is formed, starting at the first material container 140, continuing through the hollow double-sided penetration member 130, the second material container 150, the single penetration member 121, the one-way valve 171, and the plunger stopper 170 and ending at the internal volume 112 (best shown in FIGS 6D and 6E) of the syringe barrel 110.[000136] Figures 6D and 6E depict sectional views of a second example embodiment or a third example embodiment of a mixing / reconstitution syringe 200 according to the instant invention in an aspiration state after the hollow plunger 120, containing the storage rod 180, is partially withdrawn from the syringe barrel 110. The sealing member 190 at the distal end of the syringe barrel 110 does not allow the ingress of materials, including ambient / atmospheric air (not shown), from that distal end into the internal volume 112 of that syringe barrel 110 so as to enable the generation of vacuum inside that internal volume 112 upon pulling the hollow plunger 120 out of the syringe barrel 110, thereby aspirating the first material 141 (shown in FIG 6C1), including, for example, an anesthetic drug or a diluent for lyophilized drugs, through the above mentioned fluid path ending at the internal space 112 of the syringe barrel 110. In parallel to said aspiration of first material 141 (shown in FIG 6C1), the same vacuum also aspirates the second material 151 (shown in FIG 6C1), e.g., NaHCO3 solution or lyophilized drug, from the second material container 150, through the single penetration member 121, the plunger stopper 170 and the one-way valve 171 to the internal space 112 of the syringe barrel 110. [000137] One skilled in the art would appreciate that the ventilation of the inner space 144 (shown in FIG 5D1) of the first material container 140, preferably being a carpule, under these second and third preferred embodiments is not substantially different than in the first preferred embodiment. [000138] One skilled in the art would further appreciate that using a pressure member 168 (shown in FIG 5D2) for pushing the carpule piston 143 towards the carpule septum 142 instead of a ventilation member 164 (shown in FIG 5D1) for ventilating the inner space of the carpule 140,substantially as demonstrated in the first preferred embodiment to the present invention applies also to these second and third preferred embodiments to the present invention.[000139] FIG. 6E is a cross sectional view of the mixing / reconstitution syringe 200 depicted in FIG 6D in a state after the sealing cap 190 (shown in FIG 6D) is disassembled from the distal end of the syringe 200 and replaced by a needle 191, preferably being a hypodermic injection needle, that is required for proceeding with medical preparations known in the art, including removal of air bubbles from the internal volume 112 of the syringe barrel 110 and aspiration tests known in the art for the eventual injection to a target, including patient’s body.[000140] Figures 7A and 7B depict cross sectional views of two sub-assemblies, intended for assembly / disassembly by the user (not shown) of the mixing / reconstitution syringe 200 and illustrate, in combination with FIGS 6A-6E, a second and a third preferred embodiments to the mixing / reconstitution syringe 200. The first sub-assembly 210 depicted in FIG 7 A includes the at least syringe barrel 110, sealing cap 190, hollow plunger 120, plunger stopper 170 and one-way valve 171. The second sub-assembly 220 depicted in FIG 7B includes the at least fastening member 160, storage rod 180, first material container 140 containing the first material 141.[000141] Under the teachings of the second and the third preferred embodiments to the present invention, the first sub-assembly 210 may be used for multiple injections to the same target, including patient’s body, while the second sub-assembly 220 is intended for a single injection to that target. A mixing syringe set may include the aforementioned syringe barrel, hollow plunger etc., a storage rod (prepackaged inside the hollow plunger or provided separately), as well as at least one additional storage rod.[000142] Specifically under the teachings of the second preferred embodiment, mixing / reconstitution syringe 200 is provided fully assembled and only after the mixture / reconstitution 113 is injected to a target, including patient’s body, will the user (not shown) of the mixing / reconstitution syringe 200 disassemble the used second sub-assembly 220 from the first sub-assembly 210 to replace it with a new second sub-assembly 220 and as many new second sub-assemblies 220 subsequently required for as many injections required to be injected to that target, including patient’s body.[000143] One skilled in the art would appreciate that in many occasions the total volume of the mixture / reconstitution 113 drawn from one first material container 140, preferably being a carpule, and one second material container 150, is sufficient for the medical intended use, including local anesthesia and injection of emergency drug, such that there is no need to replace the used second subassembly 220 with a new second sub-assembly 220 and the entire mixing / reconstitution syringe 200 may then be discarded even under this second preferred embodiment. Nevertheless, if more volumeof the mixture / reconstitution 113 is needed, then the user (not shown) of the mixing / reconstitution syringe 200 may replace the used second sub-assembly 220 with the at least one new second subassembly 220 required for the specific medical treatment.[000144] Specifically under the teachings of the third preferred embodiment, the user (not shown) of the mixing / reconstitution syringe 200 is required to assemble the first sub-assembly 210 to the second sub-assembly 220 for using the mixing / reconstitution syringe 200 in its state depicted in FIG 6A. Then, after the mixture / reconstitution 113 is injected to a target, including patient’s body, will the user (not shown) of the mixing / reconstitution syringe 200 disassemble the used second subassembly 220 from the first sub-assembly 210 to replace it with a new second sub-assembly 220 and as many new second sub-assemblies 220 subsequently required for as many injections required to be injected to a target, including patient’s body, substantially in accordance with the teachings of the second preferred embodiment to the present invention.[000145] One skilled in the art would appreciate that principles of using the mixing / reconstitution syringe 200 under the second and the third preferred embodiments are not substantially affected by first using it fully assembled under the second preferred embodiment or assembling the first assembly 210 to the second assembly 220, when the two assemblies are provided separately under the third preferred embodiment.[000146] Figure 8 A depicts a cross-sectional view of a fourth preferred embodiment of a mixing / reconstitution syringe 300 according to the instant invention, in which that mixing / reconstitution syringe 300 consists of a syringe barrel 110 and a hollow plunger 120.[000147] The hollow plunger 120 includes both a single puncturing / rupturing member 128 (represented herein schematically) at its distal end thereof. The rupturing member including a hollow lumen in fluid communication with a one-way valve and a permeable plunger stopper. A first material container 140, preferably being a carpule, contains a first material 141, including, for example an anesthetic drug or a diluent for lyophilized drugs.[000148] The hollow plunger 120 further includes a penetrating / rupturing member 134 (represented herein schematically). In embodiments, at least one O-ring 132 is disposed between an outer surface at the penetrating / rupturing / puncturing member 134 and an inner surface at the hollow plunger 120.[000149] It should be understood that any form and shape of both the single penetrating / rupturing / puncturing member 128 (represented herein schematically) and the penetrating / rupturing / puncturing member 134 (represented herein schematically) is within the scope of the present invention.[000150] In embodiments, at least one proximal friction / carpule protrusion 125 retains the first material container 140 in a predetermined position inside the hollow plunger 120. However, it should be understood that any method for retaining that first material container 140 in a state in which it is not penetrated by the penetration-puncturing member 134 is within the scope of the present invention. [000151] The hollow plunger 120 further includes a second material capsule 310, the second material capsule 310 contains a second material 151, including, for example, NaHCO3 solution or lyophilized drug.[000152] In embodiments, the second material capsule 310 is Aluminum-Aluminum blister packing, colloquially known as alu-alu capsule.[000153] In embodiments, the margins 311 of the second material capsule 310, including alu- alu capsule, are laid on at least one capsule stopper 122 protruding from a side wall at an internal surface of the hollow plunger 120, so as that as long as external force is not applied on the proximal end 310A of the second material capsule 310, that second material capsule 310 is not engaged in physical interaction with the single puncturing member 128.[000154] It should be understood that both the first material container 140, preferably being a carpule, and the second material capsule 310 in their states as shown in FIG 8A are still not engaged with either the single puncturing member 128 nor the penetration-puncturing member 134.[000155] Figure 8B depicts a cross sectional view of a fourth preferred embodiment of the mixing / reconstitution syringe 300 according to the instant invention, in a state after the fastening member 160 is manipulated, including by screwing, to further ingress into the hollow plunger 120 causing the distal end of that fastening member 160 to push the first material container 140, preferably being a carpule, applying force that overcomes the interfering geometry of the at least one carpule protrusion 125 to be advanced towards the double penetration-puncturing member 134 until the septum 142 of that first material container 140 is penetrated by the proximal end 134A of that penetration-puncturing member 134.[000156] Figure 8C depicts a cross sectional view of a fourth preferred embodiment of the mixing / reconstitution syringe 300 according to the instant invention, in which the second material capsule 310 is squeezed by both the distal end 134B of the penetration-puncturing member 134 and the proximal end 128A of the single puncturing member 128 to a certain degree that the second material capsule 310 ruptures such that its content either fully or partially leaves the ruptured second material capsule 310. It should be understood that any method for expelling the second material 151 from the second material capsule 310 is within the scope of the present invention.[000157] To affect the state depicted in FIG. 8C, the user (not shown) of the mixing / reconstitution syringe 300 further twists / rotates / turns the fastening member 160. Consequently, the first material container 140, preferably being a carpule, advances thereby pushing the penetrationpuncturing member 134 onto the second material capsule 310 until both the distal end 134B of that penetration-puncturing member 134 and the proximal end 128A of the single puncturing member 128 puncture the second material capsule 310 and consequently the second material 151, including either NaHCO3 solution or lyophilized drug, leaves that second material capsule 310, either fully or partially.[000158] In an example embodiment, it is intended that at least one of a visual signal, an audible signal or a haptic signal is activated to indicate that the second material capsule 310 has been punctured and consequently the second material 151, including either NaHCO3 solution or lyophilized drug, left that second material container 150, either fully or partially.[000159] In embodiments, the first material container 140 is penetrated by the proximal end 134A of the penetration-puncturing member 134 after the second material capsule 310 is punctured by both the distal end 134B of both that penetration-puncturing member 134 and the proximal end 128A of the single puncturing member 128. In other embodiments, that first material container 140, is penetrated by that proximal end 134A of that penetration-puncturing member 134 before the second material capsule 310 is punctured by both the distal end 134B of that penetration-puncturing member 134 and the proximal end 128A of that single puncturing member 128.[000160] Figure 8D depicts a cross-sectional view of the fourth preferred embodiment of a mixing / reconstitution syringe 300 according to the instant invention in a state after the hollow plunger 120 is pulled out of the syringe barrel 110. The sealing cap 190 at the distal end of the syringe barrel 110 does not allow the ingress of materials, including atmospheric air (not shown), from that distal end into the internal volume 112 of that syringe barrel 110. In embodiments, the ingress of air (not shown) to that internal volume 112 is also prevented by the at least one O-ring 132, so as to enable the generation of vacuum inside that internal volume 112 upon pulling the hollow plunger 120 out of the syringe barrel 110, thereby aspirating the first material 141 (shown in FIG 8C) through the above- mentioned fluid path. In parallel to said aspiration of the first material 141 (shown in FIG 8C), the same vacuum also aspirates the second material 151, or residuals thereof, from either the second material capsule 310 itself, or anywhere within the internal volume of the hollow plunger 120, through the single puncturing member 128, the one-way valve 171 and the permeable plunger stopper 170 to the internal space 112 of the syringe barrel 110.[000161] One skilled in the art would appreciate that the ventilation of the inner space 144 (shown in FIG 8D) of the first material container 140under this fourth preferred embodiment is not substantially different than in the first, the second and the third preferred embodiment.[000162] One skilled in the art would further appreciate that using a pressure member 168 (shown in FIG 5D2) for pushing the carpule piston 143 towards the carpule septum 142 instead of a ventilation member 164 (shown in FIG 5D1) for ventilating the inner space of the carpule 140, substantially as demonstrated in the first preferred embodiment of the present invention applies also to this fourth preferred embodiment.[000163] FIG. 8E is a cross sectional view of the mixing / reconstitution syringe 300 depicted in FIG 8D in a state after the sealing cap 190 (shown in FIG 8D) is disassembled from the distal end of the syringe 300 and replaced by a needle 191, preferably being a hypodermic injection needle, that is required for proceeding with medical preparations known in the art, including removal of air bubbles from the internal volume 112 of the syringe barrel 110 and, specifically for local or regional anesthesia, also aspiration test known in the art for the eventual injection to a target, including patient’s body.[000164] As detailed heretofore, a method for using the first preferred embodiment of the mixing / reconstitution syringe 100 according to the present invention, as depicted in FIGS 5A to 5E, can be summarized in the steps detailed hereafter.[000165] In an example embodiment, the syringe 100 is prepackaged with the first material 140, including either anesthetic drug or diluent for lyophilized drugs, and the second material 151, including either NaHCO3 solution or lyophilized drug, in their containers, i.e., the first material container 140, preferably being a carpule, and the second material container 150, both containers disposed inside the hollow plunger 120.[000166] In the first step, the user manipulates, including by screwing, the fastening member 160 so as that the distal end of the fastening member 160 advances deeper inside the hollow plunger 120 and, consequently, the first material container 140, preferably being a carpule, is pushed by the distal end of the fastening member 160 onto the double-sided penetration member 130 causing the proximal end 130A of that double penetration member 130 to fully penetrate the septum 142 of that first material container 140, preferably being a carpule. From a user’s perspective, after the septum 142 of that first material container 140 is fully penetrated, the seamless continued manipulation, including by screwing, of the fastening member 160 may not be perceived as significant, yet for illustration purposes, it is described herein as a separate step.[000167] In the next step, the user continues to manipulate, including by screwing, the fastening member 160, so as that the first material container 140, is further advanced inside the hollow plunger 120 to such length that causes the second material container 150 to be penetrated from both its proximal end 150A by the distal end 130B of the double penetration member 130 and its distal end 150B by the proximal end 121 A of the single penetration member 121.[000168] In the next step, the user (not shown) pulls the hollow plunger 120 out of the syringe barrel 110. The sealing cap 190 at the distal end of the syringe barrel 110 does not allow the ingress of atmospheric air (not shown) from that distal end into the internal volume 112 of that syringe barrel 110, thereby enabling the creation of vacuum inside that internal volume 112. In embodiments, at least one O-ring 132 is also used for generating that vacuum. Consequently, the first material 141 flows from the first material container 140, preferably being a carpule, through the double penetration member 130 and into the second material container 150. Then that first material 141 flows from that second material container 150 either together with or after the flow of second material 151 from that second material container 150 through the single penetration member 121, the one-way valve 171, and the plunger stopper 170 to the internal volume 112 of the syringe barrel 110.[000169] In the next step, the user (not shown) of the mixing / reconstitution syringe 100 gently agitates that syringe 100. One skilled in the art would appreciate that this step is more applicable for ensuring the reconstitution of a second material 151, including lyophilized drug to be dissolved in the first material 141, including diluent. Nevertheless, this step may also apply to ensuring the mixing of the first material 141, including anesthetic drug with a second material, including NaHCO3 solution. [000170] In the next step, the user (not shown) of the mixing / reconstitution syringe 100 detaches the sealing cap 190 from the distal end of the syringe barrel 110 and attaches a needle 191 preferably a hypodermic injection needle, to that distal end. It should be understood that this step becomes redundant in those embodiments in which the sealing cap 190 is a one-way valve that forms part of the syringe barrel 110.[000171] In the next step, the user (not shown) of the mixing / reconstitution syringe 100 removes the protective cap 192 from the needle 191 and pushes slightly the hollow plunger 120 using a method known in the art. The hollow plunger 120 pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, both the plunger stopper 170 and the one-way valve 171 remove air bubbles from the internal volume 112 of that syringe barrel 110.[000172] In the next step, the user (not shown) of the mixing / reconstitution syringe 100 positions the distal end of the needle 191, preferably being a hypodermic injection needle, in a target,including patient’s body, and, if required for that target, performs an aspiration test known in the art. It should be understood however, that the fastening member 160 is not necessarily integrated into a thumb ring 163 as shown in FIGS 5A-8E and that the mixing / reconstitution syringe 100 may not include a thumb ring 163 at all. It should be also understood that any method for performing aspiration tests known in the art is within the scope of the present invention and that the piston of the mixing / reconstitution syringe 100 may include a conventional push-button at the proximal end of its plunger or any other configuration that enables such aspiration test to be performed.[000173] Following negative aspiration (i.e., no blood aspirated into the syringe barrel 110) at an aspiration test known in the art (to the extent required), the user injects the mixture / reconstitution 113 to a target, including patient’s body, by pushing the hollow plunger 120, which pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, the plunger stopper 170 and the one-way valve 171 expel the mixture / reconstitution 113 (for example, buffered anesthetic), from the internal volume 112 of the syringe barrel 110 through the needle 191, preferably being a hypodermic injection needle, and into the target, including patient’s body.[000174] In the next step, the user (not shown) of the mixing / reconstitution syringe 100 disposes of the mixing / reconstitution syringe in accordance with applicable facility procedures.[000175] As detailed heretofore, a method for using the second preferred embodiment of the mixing / reconstitution syringe 200 according to the present invention as depicted in FIGS. 6A to 7B can be summarized in the steps detailed hereafter.[000176] In an example embodiment, the syringe 200 is prepackaged with the first material 140, including either anesthetic drug or diluent for lyophilized drug, and the second material 151, including either NaHCO3 solution or lyophilized drug, in their containers, i.e., the first material container 140, preferably being a carpule, and the second material container 150, both containers disposed inside the storage rod 180.[000177] In the first step, the user manipulates, including by screwing, the fastening member 160 so as that the distal end of the fastening member 160 advances deeper into the storage rod 180 and, consequently, the first material container 140, preferably being a carpule, is pushed by the distal end of the fastening member 160 to advance towards the double penetration member 130. Referring now the FIGS 6B1 and 6B2, the inner threading 183 of the storage rod 180 is of such length that when the distal end 162 A of the outer threading 162 at the fastening member 160 reaches the distal end 183B of the inner threading 183 at the storage rod 180, the proximal end 130 A of the double penetrating member 130 fully penetrates the septum 142 of the first material container 140, preferablybeing a carpule. From a user’s perspective, after the septum 142 of that first material container 140 is fully penetrated, continuing to twist / rotate / turn the fastening member 160 may not be perceived as significant, yet for illustration purposes, it is described herein as a separate step.[000178] In the next step depicted in FIGS 6C1 and 6C2, the user continues to twist / rotate / turn the fastening member 160 so as that the outer threading 184 of the storage rod 180 is engaged with the inner threading 124 of the hollow plunger 120 and consequently the storage rod 180 is advanced inside the hollow plunger.[000179] The inner threading 124 of the hollow plunger 120 is of such length that when the proximal end 184A of the outer threading 184 at storage rod 180 reaches the proximal end 124A of the internal threading 124 at the hollow plunger 120 both the distal end 130B of the double penetration member 130 and the proximal end 121 A of the single penetration member 121 fully penetrate the second material container 150.[000180] It should be understood that any method known in the art for advancing either the fastening member 160 through the storage rod 180 or the storage rod 180 through the hollow plunger 120 is considered within the scope of the present invention including replacing any of the said threading with a linear ratchet (not shown) that is adapted to move along the fastening member 160 / storage rod 180 as a result of a linear force applied on said fastening member 160 / storage rod 180 by the user (not shown) of the mixing / reconstitution syringe 200.[000181] In the next step, the user (not shown) pulls the hollow plunger 120 out of the syringe barrel 110. The sealing cap 190 at the distal end of the syringe barrel 110 does not allow the ingress of atmospheric air (not shown) from that distal end into the internal volume 112 of that syringe barrel 110, thereby enabling the creation of vacuum inside that internal volume 112. In embodiments, at least one O-ring 132 is also used for generating that vacuum. Consequently, the first material 141 flows from the first material container 140, preferably being a carpule, through the double penetration member 130 and into the second material container 150. Then the first material 141 flows from that second material container 150 either together with or after the flow of second material 151 through the single penetration member 121, the plunger stopper 170 and the one-way valve 171 to the internal volume 112 of the syringe barrel 110. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiment of the present invention.[000182] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 gently agitates that syringe 200. One skilled in the art would appreciate that this step is more applicable for ensuring the reconstitution of a second material 151, including lyophilized drug to be dissolved in thefirst material 141, including diluent. Nevertheless, this step may also apply to ensuring the mixing of a first material 141, including anesthetic drug with a second material, including NaHC03 solution.[000183] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 detaches the sealing cap 190 from the distal end of the syringe barrel 110 and attaches a needle 191, preferably being a hypodermic injection needle, to that distal end. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiment to the present invention. However, it should be understood that this step becomes redundant in those embodiments in which the sealing cap 190 is a one-way valve that forms and integral part of the syringe barrel 110[000184] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 removes the protective cap 192 from the needle 191, preferably being a hypodermic injection needle, and pushes slightly the hollow plunger 120 using a method known in the art. The hollow plunger 120 pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, both the plunger stopper 170 and the one-way valve 171 remove air bubbles from the internal volume 112 of that syringe barrel 110. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiment to the present invention.[000185] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 positions the distal end of the needle 191, preferably being a hypodermic injection needle, in a target, including patient’s body, and, if required for that target, performs an aspiration test known in the art. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiment to the present invention.[000186] Following negative aspiration at an aspiration test known in the art (to the extent required), the user injects the mixture / reconstitution 113 to a target, including patient’s body, by pushing the hollow plunger 120, which pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, both the plunger stopper 170 and the one-way valve 171 expel the mixture / reconstitution 113 (for example, buffered anesthetic), from the internal volume 112 of the syringe barrel 110 through the needle 191, preferably being a hypodermic injection needle into a target, including patient’s body. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiment to the present invention.[000187] In one example embodiment, when the distal end 162B of the outer threading 162 at the fastening member 160 initially reached the distal end 183B of the internal threading 183 at aninternal surface of the storage rod 180, that fastening member 160 is locked in that position inside that storage rod 180. In an example embodiment, this locking state is affected by unidirectional snapping of an inner hurdle (not shown) protruding from the inner surface of the storage rod 180 against an outer tooth (not shown) protruding from an outer surface of the fastening member 160.[000188] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 disassembles the second sub-assembly 220 (best shown in figure 7B) from the first sub-assembly 210 (best shown in figure 7A) by disengaging the storage rod 180 from the hollow plunger 120. The same inner threading 124 at the inner surface of the hollow plunger 120 and the same outer threading 184 at an outer surface of that storage rod 180 (best shown in figure 6C2), which are initially used to advance the storage rod 180 towards the distal end of the mixing / reconstitution syringe 200, are now used in reverse direction to retreat that storage rod 180 towards the proximal end of that mixing / reconstitution syringe 200 until the distal end 184B of the outer threading 184 at an outer surface of the storage rod 180 reaches the proximal end 124A of the inner threading 124 at the hollow plunger 120 thereby disengaging the storage rod 180 from the hollow plunger 120 and consequently disassembling the second sub-assembly 220 from the first sub-assembly 210.[000189] In an example embodiment, as explained, the fastening member 160 is locked in its position inside the storage rod 180. One skilled in the art would appreciate that in that state, twisting / rotating / turning that fastening member 160 in a counter direction to which brought it to its locked position inside the storage rod 180 would engage the inner threading 124 at the inner surface of the hollow plunger 120 with the outer threading 184 at an outer surface of that storage rod 180 so as to eventually disengage the storage rod 180 from the hollow plunger 120, thereby disassembling the second sub-assembly 220 from the first sub-assembly 210.[000190] In another example embodiment, the fastening member 160 is not locked in its position inside the storage rod 180, but rather a handle (not shown) at an outer surface of that storage rod 180 is used by the user (not shown) of the mixing / reconstitution syringe 200 to disengage the second subassembly 220 from the first sub-assembly 210 by twisting / rotating / turning that storage rod 180 in a counter direction to the direction which brought it to its position deep inside the hollow plunger 120 without engaging the internal threading 183 at an internal surface of the storage rod 180 with the external threading 162 at an external surface of the fastening member 162.[000191 ] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 discards the used second sub-assembly 220 in accordance with the applicable facility procedures.[000192] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 inserts a new second sub-assembly 220 having full dosages of both a first material 140 in its first materialcontainer 141 and a second material 151 in its second material container 150, to the hollow plunger 120 from the open proximal end of that hollow plunger 120 thereby assembling that second new subassembly 220 to the first sub-assembly 210 through the engagement of the inner threading 124 at an inner surface of the hollow plunger 120 with the outer threading 184 at an outer surface of that storage rod 180.[000193] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 repeats the previous steps of this second preferred embodiment as many times as required for the target, including patient’s body, to receive the required number of injections.[000194] In the next step, the user (not shown) of the mixing / reconstitution syringe 200 discards that mixing / reconstitution syringe 200, including the last second sub-assembly 220 assembled thereto, in accordance with applicable facility procedures. One skilled in the art would appreciate that this step of the second preferred embodiment is not materially different than in the first preferred embodiments to the present invention.[000195] As detailed heretofore, a method for using the third preferred embodiment of the mixing / reconstitution syringe 200 according to the present invention as depicted in FIGS. 6A to 7B can be summarized in the steps detailed hereafter.[000196] In the first step to this third preferred embodiment, the user assembles the syringe 200, as depicted in FIG 6A, by assembling the first assembly 210 depicted in FIG 7 A with the second assembly 220 depicted in FIG 7B.[000197] In the next steps the user (not shown) of the mixing / reconstitution syringe 200 repeats all the steps of the second preferred embodiment to the present invention, as explained herein.[000198] As detailed heretofore, a method for using the fourth preferred embodiment of the mixing / reconstitution syringe 300 according to the present invention as depicted in FIGS. 8A to 8E can be summarized in the steps detailed hereafter.[000199] In an example embodiment, the syringe is prepackaged with the first material 140, including either anesthetic drug or diluent for lyophilized drug, and with the second material 151, including either NaHCO3 solution or lyophilized drug, in their containers, i.e. the first material container 140, preferably being a carpule, and the second material capsule 310, both containers disposed inside the hollow plunger 120.[000200] In the first step the user of the mixing / reconstitution syringe 300 manipulates, including by screwing, the fastening member 160 so as that the distal end of the fastening member 160 advances deeper inside the hollow plunger 120 and, consequently, pushes the first material container 140, preferably being a carpule, onto the penetration-puncturing member 134 until theproximal end 134 A of that penetration -puncturing member 134 penetrates the septum 142 of that first material container 140.[000201] In the next step, the user continues to manipulate, including by screwing, the fastening member 160, so as that the first material container 140, preferably being a carpule, is further advanced inside the hollow plunger 120 to such length that pushes the penetration-puncturing member 134 until the distal end 134B of that penetration-puncturing member 134 pushes the second material capsule 310 onto the proximal end 128A of that single puncturing member 128, so as that the pressure applied on the distal end 150B of the second material capsule 310 by the proximal end 128A of that single puncturing member 128 together with the pressure applied on the proximal end 150A of the second material capsule 310 by the distal end 134B of the penetration-puncturing member 134 erupts the second material capsule 310 allowing the second material 151, including either NaHCO3 solution or lyophilized drug, to leave that second material capsule 310.[000202] In the next step, the user (not shown) of the mixing / reconstitution syringe 300 pulls the hollow plunger 120 out of the syringe barrel 110. The sealing cap 190, either solely or together with other sealing members, including the at least one O-ring 132, does not allow the ingress of atmospheric air (not shown) from that distal end into the internal volume 112 of that syringe barrel 110, thereby enabling the creation of vacuum inside that internal volume 112. Consequently, the first material 141 flows from the first material container 140, preferably being a carpule, through the penetration -puncturing member 134 and either through or around the erupted second material capsule 310. Then the first material 141 flows from or around the second material capsule 310 either together with or after the flow of second material 151 from or around that second material capsule 310 through the single puncturing member 128, the plunger stopper 170 and the one-way valve 171 to the internal volume 112 of the syringe barrel 110.[000203] In the next step, the user (not shown) of the mixing / reconstitution syringe 300 gently agitates that syringe 300. One skilled in the art would appreciate that this step is more applicable for ensuring the reconstitution of a second material 151, including lyophilized drug to be dissolved in the first material 141, including diluent. Nevertheless, this step may also apply to ensuring the mixing of the first material 141, including anesthetic drug with a second material, including NaHCO3 solution. [000204] In the next step depicted in FIG 8E, the user (not shown) of the mixing / reconstitution syringe 300 detaches the cap 190 from the distal end of the syringe barrel 110 and attaches a needle 191, preferably being a hypodermic injection needle, to that distal end. One skilled in the art would appreciate that this step of the fourth preferred embodiment is not materially different than in the first, the second and the third preferred embodiments of the present invention. However, it should beunderstood that this step becomes redundant in those embodiments in which the sealing cap 190 forms and integral part of the syringe barrel 110.[000205] In the next step, the user (not shown) of the mixing / reconstitution syringe 300 removes the protective cap 192 from the needle 191 and pushes slightly the hollow plunger 120 using a method known in the art. The hollow plunger 120 pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, both the plunger stopper 170 and the one-way valve 171 remove air bubbles from the internal volume 112 of that syringe barrel 110.[000206] In the next step, the user (not shown) of the mixing / reconstitution syringe 300 positions the distal end of the needle 191, preferably being a hypodermic injection needle, in a target, including patient’s body, and, if required for that target, performs an aspiration test known in the art. [000207] Following negative aspiration (i.e., no blood aspirated into the syringe barrel 110) at an aspiration test known in the art (to the extent required), the user injects the mixture / reconstitution 113 to a target, including patient’s body, by pushing the hollow plunger 120, which pushes the plunger stopper 170 and the one-way valve 171 down the syringe barrel 110. While sliding down the syringe barrel 110, the plunger stopper 170 and the one-way valve 171 expel the mixture / reconstitution 113 (for example, buffered anesthetic or reconstituted drug), from the internal volume 112 of the syringe barrel 110 through the needle 191, preferably being a hypodermic injection needle, and into the target, including patient’s body.[000208] In the next step, the user (not shown) of the mixing / reconstitution syringe 300 disposes of that mixing / reconstitution syringe 300 in accordance with applicable facility procedures. [000209] One skilled in the art would appreciate that the principles of using the mixing / reconstitution syringe 100 under the first preferred embodiment and the mixing / reconstitution syringe 300 under the fourth preferred embodiment, both not having a storage rod 180, are not substantially different than those of using that mixing / reconstitution syringe 200 under the second and the third preferred embodiments, both having a storage rod 180.[000210] One skilled in the art would further appreciate that penetrating the second material container 150 by both the single penetration member 121 and the double penetration member 130 under the first, the second and the third preferred embodiments is not substantially different than puncturing the second material capsule 310 by the single puncturing member 128 and the penetrationpuncturing member 134 under the fourth preferred embodiment to the present invention.[000211 ] While embodiments of the present invention have been disclosed, it will be appreciated by those skilled in the art that the invention is subject to variations and modifications, and it is intendedthat the invention will not be limited only by the following claims. The mixing / reconstitution syringe may serve to enhance the in-situ mixing of chemicals, cosmetics, glues, including medical glues, as well as other applications not specifically mentioned here, or applications not yet contemplated. The materials contained in the second material container 150, second material capsule 310 and the first material container 140 may be, or include, solid particles (e.g., a powdered substance), fluid, gas, gel, viscous material, or a mixture of any or all of the above. Coloring, clouding, other reagents, or other materials / reagents may be used to visually indicate mixing of the components or leakage from the second material container. Either the plunger stopper, the second material container or both of them may be made of rubber, or an elastoplastic composition that is rigid, semi-rigid, or mainly rigid and / or including an elastic portion. Alternatively, they may be mainly elastic / flexible with a rigid portion, or they may be elastic plastic. Any of the parts may include features that improve, simplify or shorten the manufacturing of those parts or improve, simplify or shorten the assembling of the overall apparatus, including the sub-assemblies contemplated herein. Any of the parts or the overall apparatus may include features that improve the visual marketing appeal of the apparatus. The hollow plunger 120, the storage rod 180, the double penetration chassis 133, the penetration-puncturing member 134, the single penetration member 121, the single puncturing member 128, the fastening member 160, the stopper 170 and the one-way valve 171, while described in the embodiments as having a generally circular cross-section in one plane, may have any other shape in cross-section that permits use.[000212] All parts may be made of elastomeric plastic or any other material which is consistent with the purpose of the present invention. The second material container 150 and the second material capsule 310 may take the form of a sphere, convex disc, bellow, or any other form which is consistent with the purpose of the present invention.[000213] The flowcharts and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and / or flowchart illustration, and combinations of blocks in the block diagrams and / or flowchart illustration,can be implemented by special purpose hardware — based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.[000214] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.[000215] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.[000216] The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.[000217] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub — combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.[000218] While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made. Therefore, the claimed invention as recited in the claims that follow is not limited to the embodiments described herein.

Claims

WHAT IS CLAIMED IS1. A mixing syringe, comprising: a) a syringe barrel; b) a sealing member disposed at a distal end of the syringe barrel; c) a hollow plunger slidably received in the syringe barrel and including: i) an internal volume dimensioned to receive therein a first material container, a second material container, and a double-sided penetration member disposed therebetween; ii) a single penetration member protruding from an inner wall at a distal end of the hollow plunger; iii) a one-way valve disposed within a permeable plunger stopper at the distal end of the hollow plunger and in fluid communication with the single penetration member; wherein the double-sided penetration member is hollow and has a proximal end positioned to initially not penetrate the first material container, when inserted in the hollow plunger, and a distal end positioned to initially not penetrate the second material container, when inserted in the hollow plunger; and d) a fastening member engageable with a proximal end of the hollow plunger and linearly moveable within the hollow plunger.

2. The mixing syringe of claim 1, wherein the first material container containing a first material and the second material container containing a second material are disposed inside the hollow plunger and wherein the mixing syringe has: a) a resting state wherein the first material container is not penetrated by the proximal end of the double-sided penetration member and the second material container is not penetrated by either the distal end of the double-sided penetration member or the single penetration member;b) a first penetration state wherein the fastening member is advanced distally such that the first material container is penetrated by the proximal end of the double-sided penetration member; c) a second penetration state wherein the fastening member is further advanced distally such that the second material container is penetrated by both the distal end of the double-sided penetration member and the single penetration member; d) an aspiration state wherein the hollow plunger is partially withdrawn from the syringe barrel and a solution, including the first material and the second material, has been aspirated through the single penetration member, the one-way valve, and the permeable plunger stopper into an internal volume of the syringe barrel defined by internal surfaces of the syringe barrel and an external exposed surface of the permeable plunger stopper; and e) an injection state wherein a needle is attached to the distal end of the syringe barrel, the hollow plunger is pushed towards the distal end of the syringe barrel and a solution, including the first material and the second material, has been injected through the needle to a target.

3. The mixing syringe of claim 2, wherein the hollow plunger is prepackaged with the first and the second material containers and the double-sided penetration member.

4. The mixing syringe of claim 1, wherein the fastening member has an external threading which is adapted to be threadably engaged with a matching internal threading of the hollow plunger.

5. The mixing syringe of claim 2, wherein the first material container is insertable into the hollow plunger.

6. The mixing syringe of claim 2, wherein the double-sided penetration member is movably disposed between the first and second portions of the internal volume of the hollow plunger.

7. The mixing syringe of claim 1, wherein a proximal portion of the internal volume of the hollow plunger has dimensions suited to receive therein the first material container which isselected from a group of containers each having a given diameter and a length selected from a range of predefined lengths.

8. The mixing syringe of claim 2, wherein a distal portion of the internal volume of the hollow plunger has dimensions corresponding to dimensions of the second material container.

9. The mixing syringe of claim 2, wherein the hollow plunger includes at least one proximal friction protrusion disposed / formed on an internal surface of a chassis retaining the double-sided penetration member, the at least one proximal friction protrusion adapted to retain or restrain the first material container in a state in which the first material container is not penetrated by the proximal end of the double-sided penetration member.

10. The mixing syringe of claim 2, wherein the hollow plunger includes at least one distal friction protrusion disposed or formed on an internal surface of a chassis, the at least one distal friction protrusion adapted to retain or restrain the second material container in a state in which the second material container is not penetrated, on a proximal end thereof, by the distal end of the double-sided penetration member, and not penetrated, on a distal end thereof, by the single penetration member.

11. A multi-use mixing syringe, comprising: a) the syringe barrel of claim 2; b) the sealing member of claim 2; c) the hollow plunger of claim 2; d) a storage rod slidably receivable in the hollow plunger and including:(i) the first material container;(ii) the second material container;(iii) the double-sided penetration member; and(iv) a rod-fastening member engageable at a proximal end of the storage rod and linearly moveable within the storage rod;wherein the storage rod includes an inner threading at an inner surface thereof and an outer threading at an outer surface thereof; wherein the inner threading of the storage rod corresponds to an outer threading of the rodfastening member; and wherein the outer threading of the storage rod corresponds to an inner threading of the hollow plunger.

12. The mixing syringe of claim 11, wherein a proximal portion of the internal volume of the storage rod has dimensions suited to receive therein the first material container selected from a group of containers each having a given diameter and a length selected from a range of predefined lengths.

13. The mixing syringe of claim 11, wherein a distal portion of the internal volume of the storage rod has dimensions corresponding to dimension of the second material container.

14. The mixing syringe of claim 11, wherein the double-sided penetration member is movably disposed between the first and second portions of the internal volume of the storage rod.

15. The mixing syringe of claim 11, wherein the storage rod includes at least one proximal friction protrusion disposed or formed on an internal surface of the storage rod, the at least one proximal friction protrusion adapted to retain or restrain the first material container in a state in which the first material container is not penetrated by the proximal end of the double-sided penetration member.

16. The mixing syringe of claim 11, wherein the storage rod includes at least one distal friction protrusion disposed / formed on an internal surface of the storage rod, the at least one distal friction protrusion adapted to retain or restrain the second material container in a state in which the second material container is not penetrated, on a proximal end thereof, by the distal end of the double-sided penetration member and not penetrated, on a distal end thereof, by the single penetration member.

17. The fastening member of claim 2 or the rod-fastening member of claim 11 including a thumb ring at its proximal end.

18. The mixing syringe of claims 2 or 11, wherein the fastening member of claim 2 or the rod-fastening member of claim 11 includes a ventilation member at a distal end thereof, wherein advancing the fastening member inside the hollow plunger or the rod-fastening member in the storage rod, causes a distal end of the ventilation member to fully penetrate a piston of the first material container and ventilate the first material container through an air inlet at a proximal end of the ventilation member.

19. The mixing syringe of claims 2 or 11, wherein the fastening member or rod-fastening member includes a spring at a proximal end thereof, the spring applying a constant biasing force on a piston of the first material container.

20. The mixing syringe of claim 2 or 11, wherein the distal end of the syringe barrel is adapted for replaceably receiving thereon a detachable sealing cap and a needle.

21. The mixing syringe of claim 20, wherein the needle is a hypodermic injection needle.

22. The mixing syringe of claim 2, wherein further distal advancement of the fastening member in the second penetration state pushes the first material container onto an internal wall of a chassis retaining the double-sided penetration member and further pushes the second material container distally such that the second material container is penetrated by the single penetration member.

23. The mixing syringe of claims 2, wherein the fastening member is further advanced distally in a second penetration state such that the second material container is ruptured by pressure created between the distal end of the double-sided penetration member and the proximal end of the single penetration member.

24. The mixing syringe of claim 23, wherein the second material container is cold-form foil blister package.

25. A mixing syringe set comprising:(a) the mixing syringe of claim 1;(b) the first material container inserted into the hollow plunger, the first material container having a first material disposed therein;(c) the second material container having a second material disposed therein.

26. A mixing syringe set comprising:(a) the mixing syringe of claim 11;(b) at least one additional storage rod of claim 11.

27. The mixing syringe set of claim 26, wherein the syringe is adapted to be reused by replacement of the storage rod initially disposed inside the hollowed plunger with the at least one additional storage rod.

28. The mixing syringe set of claim 26, wherein the storage rod is provided separately.

29. The mixing syringe set of claim 28, wherein the syringe is adapted to be reused by removal of the storage rod and insertion of the additional storage rod.

30. The mixing syringe set of any one of claims 25 or 26 or 28, wherein the first material container is a carpule.

31. The mixing syringe set of any one of claims 25, 26, or 28, wherein the first material is selected from the group of materials including: a solid, liquid, gas, any intervening state therebetween, and combinations thereof.

32. The mixing syringe set of any one of claims 25, 26, or 28, wherein the first material is an anesthetic drug and the second material is a buffering or a Ika lin ization solution.

33. The mixing syringe set of claim 32, wherein the second material container includes a quantity of the second material sufficient to bring a pH level of the first material disposed in the first container closer to physiological pH level of a patient.

34. The mixing syringe set of any one of claims 25, 26, or 28, wherein the first material is a diluent and the second material is a lyophilized drug.

35. The mixing syringe set of claim 34, wherein the first material container includes a quantity of the first material that is sufficient to fully reconstitute the second material disposed in the second material container.

36. A method for mixing a first material and a second material in a mixing syringe for their injection to a target, the method comprising the steps of:(a) providing the mixing syringe of claim 2 or the mixing syringe set of claim 26;(b) advancing the fastening member or rod-fastening member such that the mixing syringe goes from the resting state to the first penetration state;(c) advancing the fastening member or rod-fastening member further such that the mixing syringe goes from the first penetration state to the second penetration state;(d) partially withdrawing the hollow plunger from the syringe barrel creating a vacuum in the syringe barrel such that the mixing syringe progresses from the second penetration state to the aspiration state; and(e) pushing the hollow plunger such that the mixing syringe progresses from the aspiration state to the injection state.

37. The method of claim 36, further comprising:(f) replacing the storage rod with an additional storage rod; and(g) repeating steps (b) to (e) for as many injections required to the same target.

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