Multi-chambered mixing vial with access system and interface needle

Abstract

A multi-chambered mixing vial with an access system and interface needle for mixing and dispensing a medical fluid. The vial has a first chamber with a fixed volume and a second chamber with a variable volume. The first chamber houses a medicament, while the second chamber contains a liquid diluent or active component. The mixing container is a hollow, tubular plunger with an elastomeric stopper at its outer end and a plunger seal at its inner end. The supplemental container is a cylindrical vial tube mounted to the mixing container. An Interface needle, placed inside the supplemental container, pierces the plunger seal and transfers fluids from the first chamber to the syringe. The access system, comprising two cylindrical inserts, provides access to a medical fluid contained in the vial by the use of a needleless syringe. A floating cylindrical balloon is disposed within the first chamber, creating a hermetic seal with the inner walls of the barrel. The mixing and supplemental containers are made of glass or a pharmaceutically compatible plastic. The process of mixing involves collapsing the mixing and supplemental containers from a pre-mixed condition to a post-mixed condition, allowing the components to mix in the first chamber. The needle penetrates the floating balloon, causing the liquid content of the balloon's interior chambers to mix with the contents of the first chamber. The needle then penetrates the septum and enters the adapter's interstitial space, completing the collapsing stage. The liquid medicine is then drawn from the vial into a syringe.

Description

Multi-Chambered Mixing Vial with Access System and Interface Needle

[0001] The present invention relates to the field of medical devices and pharmaceutical packaging, and more specifically, to a multi-chambered mixing vial with an access system and interface needle, used for mixing two or more pharmaceutical components, at least one being liquid, in a controlled fashion for subsequent aspiration into a syringe.

[0002] More particularly the present invention is designed for the storage, mixing, and transfer of pharmaceutical substances, particularly those requiring the combination of a medicament and a diluent or active component.

[0003] The invention is applicable in various healthcare settings, including hospitals, clinics, and home care, where safe and efficient preparation and administration of medication are required.

[0004] The technical aspects of the invention involve mechanical engineering principles related to the design of the mixing container, supplemental container, interface needle, and access system, and also encompasses fluid dynamics principles related to the transfer of fluids between chambers and into a syringe.

[0005] The field of medical fluid storage and delivery has seen significant advancements over the years. Traditional methods often involve the use of separate containers for storing different components of a medicament, such as the active ingredient and the diluent. These components are typically mixed immediately before administration to the patient. However, this process can be cumbersome and prone to errors, especially in high-stress environments like hospitals and clinics.

[0006] Several solutions have been proposed to address these issues. For instance, dual-chambered vials have been developed to store the medicament and diluent in separate compartments within the same container. These vials typically employ a movable barrier or seal to keep the two components separate until mixing is required. Despite their advantages, these systems still present challenges. The process of mixing the components often requires multiple steps and can be difficult to perform correctly, especially for untrained individuals. Furthermore, these systems often require the use of a separate syringe for administration, adding to the complexity of the process.

[0007] Another approach involves the use of a floating plunger within the vial to separate the medicament and diluent. While this design simplifies the mixing process, it can still be difficult to ensure a complete and thorough mix of the components. Additionally, the use of a floating plunger can lead to issues with leakage and contamination.

[0008] In light of these challenges, there is a need for a more efficient and reliable system for storing and mixing medicaments. Such a system should allow for easy and accurate mixing of the components, minimize the risk of contamination, and be simple to use, even for individuals with limited training. The present invention seeks to address these needs.

[0009] The present invention addresses several technical problems associated with the preparation and administration of injectable medicaments, particularly those requiring dilution or reconstitution before use.

[0010] 1.Time-ConsumingPreparation:The conventional method of preparing injectable medicaments involves multiple steps, including fitting a sterile needle to a syringe, drawing the liquid contents of a vial, and pouring it into a medicine vial to form a liquid drug. These steps are time-consuming and can delay the administration of the medicament, particularly in emergency situations where rapid preparation is required.

[0011] 2. Safety Concerns: The conventional method of preparation also poses safety risks. Medications may not mix well or may mix with air, the needle used may cause injury, and sterile principles may not be followed.

[0012] 3.Storage and Mixing of Two-Component Medications:Problems associated with the rapid preparation of injectable drugs become further complicated when the components to be administered, such as a diluent solution and a concentrated drug, are stored in two separate vials. Dual chamber vials have been developed to facilitate storage and mixing of these two-component medications. However, existing designs, such as the MIX-O-VIAL two compartment vial, have significant disadvantages. For instance, the intermediate stopper does not provide enough safety to store contents separately and may loosen or dislodge due to impact or severe displacement and shaking over time.

[0013] 4. Rupture of Rupturable Barrier:In designs where a rupturable barrier is used to separate the two chambers, the rupture of the barrier depends on the application of pressure. If the barrier is thin enough, it may rupture due to shocks and shaking caused by transport and displacement.

[0014] The present invention aims to provide a solution that overcomes these technical problems, offering a safer, more efficient, and more reliable method for the preparation and administration of injectable medicaments. The invention seeks to improve the storage and mixing of two-component medications, enhance the safety of the contents, and facilitate the rapid preparation of injectable drugs.

[0015] The present invention provides a solution to the problems associated with the preparation of injectable medicaments, particularly those requiring dilution or mixing of two components prior to administration. The invention addresses the need for a rapid, safe, and efficient method of preparing such medicaments, especially in medical and emergency conditions.

[0016] This invention provides a significant improvement over existing solutions by offering a faster, safer, and more efficient method of preparing injectable medicaments. It eliminates the need for separate storage and mixing of medicament components, reduces the risk of contamination, and improves the accuracy of dosage measurements. Furthermore, the invention is compatible with a wide range of medicaments and diluents, making it a versatile solution for various medical and emergency applications. The invention is designed to meet the increasing worldwide demand for medical devices that offer faster preparation, enhanced safety, and easy access to content. It is expected to have a significant impact on the field of medical device technology and patient care.

[0017] The Multi-Chambered Mixing Vial with Access System and Interface Needle presents several advantageous effects that enhance the safety, efficiency, and convenience of preparing injectable medicaments:

[0018] 1. Efficient Preparation:The invention significantly reduces the time required for the preparation of injectable medicaments. By housing both the medicament and the diluent or active component in separate chambers within the same vial, the need for separate packaging and handling is eliminated. This results in a streamlined and efficient preparation process.

[0019] 2. Enhanced Safety:The design of the mixing vial ensures that the medicament and the diluent remain securely separated until the point of mixing. This prevents premature mixing or contamination, enhancing the safety of the medicament. Furthermore, the use of an Interface needle and a needleless syringe access system minimizes the risk of needle-stick injuries.

[0020] 3. Precise Mixing:The invention allows for precise control over the mixing process. The telescoping design of the supplemental container and the use of a floating cylindrical balloon ensure that the medicament and the diluent mix thoroughly and evenly. This ensures the correct concentration of the medicament, enhancing its efficacy.

[0021] 4. Versatility:The mixing vial can accommodate medicaments in various forms - powder, solid, or liquid. This makes the invention versatile and suitable for a wide range of medicaments.

[0022] 5. Durability and Compatibility:The preferred use of glass or pharmaceutically compatible plastic for the mixing and supplemental containers ensures the durability of the vial and compatibility with various medicaments. This prevents any potential reactions between the vial material and the medicament.

[0023] 6. Ease of Use:The design of the vial, including features such as the rotary movement for collapsing the containers and the lines on the vial body for measuring the volume of liquid, make the vial easy to use even in emergency conditions.

[0024] In conclusion, the Multi-Chambered Mixing Vial with Access System and Interface Needle provides a significant advancement in the field of medical devices for the storage, preparation, and administration of injectable medicaments. Its innovative design and advantageous effects align with the increasing worldwide demand for medical devices that offer faster preparation, enhanced safety, and easy access to content. This invention is expected to have a positive impact on healthcare practices and patient outcomes.

[0025] In order to understand the invention and to see how it can be carried out in practice, Preferred embodiments of the invention are described below with reference to the following accompanying drawings which similar parts are likewise numbered, wherein:

[0026] is a cross sectional view of The Multi-Chambered Mixing Vial in accordance with the present disclosure;

[0027] shows a schematic side view of The Multi-Chambered Mixing Vial of the present disclosure;

[0028] [Fig.3]is a longitudinal cross section of The Multi-Chambered Mixing Vial according to aof the invention;

[0029] [Fig. 4-7]shows a cross-sectional view of The Multi-Chambered Mixing Vial to illustrate its operation;

[0030] is an exploded perspective view of the assembly shown inaccording to an embodiment of the invention;

[0031] [Fig.9-12]shows close-up longitudinal cross-section view of The Multi-Chambered Mixing Vial that illustrates the operation and use of the present disclosure;

[0032] One efficient method of providing the combination drugs is to utilize a package comprising a vial of two or more compartments such as that disclosed inThe compartments and drugs being separated by a seal until use.

[0033] Reference is now made to the drawings of Figs. 1-3 illustrating the present invention. Themixing vial 1hasfirst 2andsecond chambers 3.

[0034] Thefirst chamber 2is a fixed volume chamber that is housed within themixing container 4between thestopper 5and theplunger seal 6and contains amedicament 55in the form of a powder, solid or liquid.

[0035] Thesecond chamber 3is a variable volume chamber is created by atelescoping supplemental container 7mounted to a second end of themixing container 4and includesliquid contents50in the form of diluent only or an active component.

[0036] As shown in the exploded perspective view of, themixing vial 1in generally and in the schematic view comprises: amixing container 4, asupplemental container 7and anInterface needle 8, that each of these parts has subset components.

[0037] Amixing container 4is a hollow, tubular plunger with an elastomericstopper 5at its outer end and aplunger seal 6at its inner end.

[0038] Asupplemental container 7is acylindrical vial tube 9with a closed bottom and open top, is coaxially translatable mounted to themixing container 4.

[0039] AnInterface needle 8is placed inside thesupplemental container 7in coaxial line with the longitudinal axis of the vial.

[0040] Themixing container 4comprises acylindrical tubular plunger 10, aplunger seal 6and astopper 5. The tubular plunger, preferably made of glass, is a hollow plunger, with two open ends. It is configured such that thestopper 5andplunger seal 6are installed at its two ends.

[0041] Theplunger seal 6is installed at its inner end of the tube, and thestopper 5is installed at its outer end of the tube. The hollow interior space of the tube forms a drug storage chamber, referred to as thefirst chamber 2, the body of the tube has protrusions on its outer surface, including aninitialembossment ring96,afinal embossment ring 11, and aTentacles12.

[0042] First embossment ring96limit movement from the pre-mixed condition except with the chosen rotary movement andsecond embossed ring11prevents all movement from the post-mixed condition. Asheath house 13covering around the mixed container.

[0043] Aplunger seal 6is a cup that covers the distal end of the vial tube and has a proximal surface extending outward the edges of the vial tube to engage the walls of the vial tube to form a fluid tight seal with the vial during use.

[0044] Theplunger seal 6capable of being pierced by a needle. The External edges (outer end) of theplunger seal 6has apist flange 14extending outwardly and located adjacent a recess in the plunger so theplunger seal 6forms a snap fit over the seal flange and extends into the recess.

[0045] The pist flange causes theplunger seal 6to bulge sufficiently outward to form a fluid tight seal during use, and anelastic ring 15installed on the open end of thesupplemental container 7Completes sealing.

[0046] The plunger seal can havea complementary layer 67that is placed on the inner surface of thesupplemental container 7and, if needed to separate the mixing container and thesupplemental container 7, remain in thesupplemental container 7and cover the second chamber.

[0047] On the bottom outer surface of the aplunger seal 6, there areprotruding rings 16that, as shown in FIG. 7, in thecomplete collapsing state 17insert into 102thecircular grooves 18 of Insole35thesecond chamber 3of the container, and there is ablind hole 19in the center that in the base state the needle head is placed in it.

[0048] The central axis 56of the plunger seal has the least thickness and is permeable and can be pierced to the tip of the needle.

[0049] A stopper 5comprises a rubber-like elastomeric cylindrical shape which is used to seal the opening of the vial, that is compatible with the pharmaceutical product and prevents the escape of liquid or gas from the vial, with acentral fossa 21at top surface and a closed flat at bottom surface and also equipped with aaccess system 22that is inserted into thecentral fossa21, and allows a needlessmedical syringe 23for accessing the pharmaceutical content.

[0050] Also In one of embodiments of the invention, thestopper 5further preferably comprises theextrusion lines 20having an penetrable texture, which provides easy penetrability to a needle, thereby enabling access to the contents of the inner space of the vial by penetrating the needle tip when the user wants to withdraw the contents of the vial using the needle and also the extrusion line can act as a one -way air filter and allow the air to exit the vial, after thelid 43was removed.

[0051] Thestopper 5further preferably has a flange that extends radially from the top surface and rests on the rim of the vial, providing a secure and stable closure and is designed to minimize the formation of visible particles caused by the coring of the rubber material when thestopper 5is punctured and also resistant to chemical degradation and microbial contamination, ensuring the quality and safety of the pharmaceutical product, as shown in Figs. 9 and 12.

[0052] The access system, generally designated by thenumeral 22, which is also described as the accessadaptor 22, provides access to amedical fluid 25contained in the vial by the use of aneedleless syringe 23.

[0053] Theaccess adapter 22, comprises two component parts: A cylindrical bottom insert, which is also described as the holder piece, generally designated by thenumeral 26, positioned in the elastomericstopper 5; and a cylindrical top insert, which is also described as the female luer, generally designated by thenumeral 27, positioned in the bottom insert.

[0054] The holder piece, which is known as the a cylindricalbottom insert 26, comprises a hollow cylindrical wall with the closed end by a layer ofpenetrable septum 32and with an inner receiving portion and an outer surface having the ribbedfingers engagement 33, that the ribbedfingers engagement 33on the outer wall surface are for engaging with the inner wall of the stopper 5 and staying the bottom insert in place.

[0055] The inner portion of the bottom insert includes aninsole septum 32and acylindrical inner wall 73that form an inner annular groove 36 and a central hole 34.The annular groove 36has innerhelix thread 39and the location for placing thespring 37and thelock skirt 40.

[0056] The female luer 27 is a cylindrical top insert 27 that is placed inside the hole of the cylindrical bottom insert 26, and has a hollow cone 106 and a connecting opening 42 for connection to the tip of the syringe 28 and a lock skirt 40 and a nose 38, that the lock skirt 40 that is placed inside the annular cylindrical groove 36 of the holder piece 26 , and the nose 38 having a piercability cap 44 wherein the cap is configured with permeable structure to allow the needle tip 45 to pierce the nose 38, and having a neck that the edges of the neck have pores 30.

[0057] The method of accessing themedical fluid 25includes the steps of: placing thetip of a needleless syringe 28or a syringe head equipped to with a luer lock that is named as external access on theexit port 72of the adapter; then attaching the external access to the axially access adapter 22; exerting a pushing force on theexit port 72of the adapter to move thetop insert 27into the bottom of the closed position;

[0058] Theaccess adapter 22is usable in bothreturn valve 24andnon-return valve position mode 47. By connecting the syringe tip tothe female luer 27and applying initial pressure to thecylindrical top insert 27, preferably with rotation, thecylindrical top insert 27moves down one step and thelateral pores 30that were initially in contact with the inner wall of the connector holder piece open asthe female luer 27moves down and thus a limited path is created through the lateral ports 30 to theinterstitial space 31.

[0059] In this mode, thecylindrical top insert 27acts as a swing valve, such that when the initial pressure is applied, Continued movement in the direction of arrows111, and thecylindrical top insert 27moves down, the spring is compressed and when the pressure is removed, the spring is released andthe female luer 27returns to its previous state and thelateral ports 30are covered, thus closingthelimited access path 51to the contents of the vial, as shown in Figs. 9 and 12.

[0060] In the non-return valve position mode 47, the cylindrical top insert 27 is as a fixed valve, such that after the initial pressure, preferably accompanied by rotation, which is applied by the syringe tothe female luer 27, with the secondary pressure, the cylindrical top insert moves downward until the needle tippenetrates the piercability cap105and the edges of the head engage withthe internal protrusions 49of the cylinder and thus the cylindrical top insert is in the non-return valve mode.

[0061] In this case, by applying the initial pressure, the female luer comes down to the extent thatthe middle teeth 107on the body of thelock skirt 40are involved with the edges of the annular groove 36, and this conflict restricts the continuation of the female luer's downward movement except by pressure Secondary, as shown in Figs. 9 and 12.

[0062] In thenon-return valve mode47,the female luer 27is a fixed valve, such that after the initial pressure, preferably accompanied by rotation, which is applied by the syringe tothe female luer 27, with the secondary pressure,the female luer 27moves downward untilthe needle tip penetrates the piercability cap105.

[0063] When the edges of the head engage withthe internal protrusions 49causes blockedthelimited path 51of these port, thus the female luer is in the non-return valve mode, as shown in Figs. 9 and 12.

[0064] The mixing container having a hollow interior space is referred to as a first chamber; and acylindrical balloon54disposed within the first chamber.

[0065] Floating piston 54is a type of plunger that is not attached to any rod or handle, but rather moves freely inside the barrel due to the pressure difference between the two ends.Afloating piston 54can create a hermetic seal with the inner walls of the barrel, preventing any air or liquid leakage.

[0066] Afloating piston 54can also reduce the amount of drug overfill and wastage, as well as minimize the risk of microbial contamination and dosing errors.

[0067] In the embodiment shown in, The floating balloon is a cylindrical piston hasbubble chambers 59andanabdominal chamber 60filled with medicinal liquids, that all chambers are attached to the navel 61 byducts 62,thenavel 61is located in the central space of the cylinder and is permeable to the needle.

[0068] The chambers of thefloating balloon54can be elastic and the walls of these chambers are swollen when the drugs are filled, so with the needle's penetration into thefloating balloon54and piercing and creating a way out of thefloating balloon 54,the contents are exited by pressure from the floating balloon, andalso Internal bumps 53control the position of the floating balloon.

[0069] On the outer margin of thefloating balloon54there are gaskets that are in contact with the inner wall of the container and sealing and facilitate the movement of thefloating balloon54inside the tube.

[0070] Asupplemental container 7is acylindrical vial tube 9with a closed bottom and open top, is coaxially translatable mounted to themixing container 4. Thesupplemental container 7is a cylindrical vessel with an open mouth and a closed bottom. The end of themixing container 4is collapsible installed in themouth 64 of the supplementary container.

[0071] Asealing ring 15is placed on theedges of the open mouth of the supplemental container 66. The interior space of thesupplemental container 7forms asecond chamber 3. An intermediary needle is installed in thesecond chamber 3of thesupplementary container 7.

[0072] Furthermore, a groovedInsole 35is placed at the bottom of thesecond chamber 3, which directs the flow of liquids towards the lower ports of the needle.

[0073] In an alternative embodiment of the invention, preferably a small hole is located at the center of the lower end of thesupplementary container 7, which is sealed by atipped cover88, this cover is penetrable by theneedle tip89, thus providing access to the contents of thesecond chamber 3by aBelone connector90.

[0074] Also, in an alternative embodiment, the end of thesupplementary container 7preferably has a location for aBelone connector 90has a short needle with a sharp tip 89, which provides access to the contents of thesecond chamber 3using aneedleless syringe 23.

[0075] In this way, by placing the syringe tip and pressing inward, the sharp tip 89 of theBelone connector 90pierces thetipped cover88of the end of thesupplementary container 7and enters theinterior space 71of the needle hub.

[0076] TheBelone connector 90has a structure and components similar to the access system and comprises;

[0077] A piercing spike 89, which is a sharp plastic or metal tip that punctures the rubber tipped cover 88 and creates a fluid pathway.

[0078] A needle-free connect valve 91, which is a valve that prevents the leakage of fluid or air and allows the attachment of a syringe or an infusion set without a needle.

[0079] A cylindrical ballet 92, which is fall into theHolder'scylindrical gap 95with thesprinkle springs 93, and the sum of their assembly causes prevents the movement of the connector except by applying pressure with rotation.

[0080] The connector has a structure and components similar to theaccess system 22, except that it has a piercing spike 89 instead of a permeable nose 38. The connector is inside in aholder94and theholder 94preferentially fixed in astopper -like texture 97.

[0081] Additionally, at the end of the body of thesupplementary container 7, There is anextra wall70 are created that serve as a hold base, and has threads of the inner and outer edge of this wall and also aprotective cover 75andend lids 46,48are screwed onto the threaded edge.

[0082] There arethreaded 57on theprominent ring 58on the outer wall surface of the complementary container whose surface threads are involved with the inner surface ofthe sheath house 13, this makes a rotational motion first needed for vial collapsing.The circular bumpsof the sheath house involved with the surface of the prominent ring conditioning the start of the collapsing to an initial pressure.

[0083] An Interface needle 8, which is also described as the hollow needle, is composed of a shaft, a hub and a connecting flange.

[0084] The shaft 76is a hollow slender stem with asharp tip bevel45, which haslumen and or apertures99, and used to pierce theplunger seal 6and piercingthenavel 61and piercing thestopper 5, and transferring fluids from thefirst chamber 2to the syringe and allowing medical fluid 25 to pass through it, for the fluid to enter or exit the needle and exchange fluids between space of the first2andsecond chambers 3,

[0085] The needle shaft76can be made of coated stainless steel or any material that has enough strength and does not react with liquids and pharmaceutical contents. The perforated hub is a swollen hollow rod of the needle whose leads from the top to the shaft and the bottom to the flange and having the sideperforations 68.

[0086] The hub77is usually made of metal or plastic or glass,The diameter of the hub part of the hollow needle is larger than the diameter of the rod part of the needle body,

[0087] Aguide sleeve 69is disposed inside the upper half of the hub dotted bulge, and the fluids that penetrate into the dispensing reservoir of the hub throughthe perforations 68are directed bythe guide sleeve 69towards downward and then into inlet of the hollow rod in thereservoir 71of the hub.

[0088] The connecting flange65is placed the end of the needle and holds the needle to theflat floor 74of the second chamber of the supplemental container and It can either have a threaded lock mechanism or a friction fit to secure the needle connection to thesupplemental container 7that ensures the needle does not detach from thesupplemental container 7.

[0089] When the vial collapsing is completed,the perforations68of the upper part of the hub are open inside thefirst chamber 2, andthe perforations68of the lower part of the hub are blocked by the mantle of theplunger seal 6, Therefore, when the contents are dragged by the syringe, the liquid contents from the upper holes of the hub tothe interior down of the hub82and then dragged to the vial adapter via the hollow shaft of the needle.

[0090] Themixing container 4andsupplemental receptacle 7are preferably glass or a pharmaceutically compatible plastic; thesheath house 13is preferably made of polycarbonate.

[0091] As shown in the cross section of FIG. 5-4, Collapsing themixing 4andsupplemental containers 7from a pre-mixed condition to a post-mixed condition, at first preferably starts with a chosen rotary movement usingthreads78,57, rotary movement opens thescrew connection 78and it removes thebarrier 63of movement on the longitudinal axis and it takes the joint between the two vials1cout of constant state then by entering theforce from the top109and the bottom 110in the inside direction to be collapse the containers telescopically into each other,

[0092] Continued movement in the direction of arrows109,110and this causing fluid pressure in thesecond chamber 3and causes the tip of theInterface needle 8to penetrate into theplunger seal 6and then cross the layers and enter themixing container 4chamber, so the liquid or second pharmaceutical 50 to be transferred into themixing container 4through theInterface needle 8and then the components mix in thefirst chamber 2,

[0093] So that In the first place,thesecond chamber 3fluids enter 100 the needle hubthroughthe perforations 68,as indicated by arrows100, andexit 101thelumen and or apertures 99of the sharp tip bevel45of the needle, as indicated by arrows101.

[0094] As shown in the cross section of FIG. 7-5, Then, by continuing to collapsing1c, the needle penetrates thenavel 61of thefloating balloon 54and pierces the balloon, as a result, the liquid content of the chambers of the balloon interiorleaks from the rupture79;

[0095] as shown in FIG. 5, and is sprayed into thefirst chamber 2space and then mixed with the contents of thefirst chamber 2, in the following, collapsing, When the needle perforates the floating balloon 54 after the needle-inducedperforation 81, and reaches the stopper 5 andpenetrates the stopper 103, the upper part of the hub 80has passed through the plunger seal 6 and enters thefirst chamber 2, whilethe lower part of the hub83remains in thesecond compartment 3;

[0096] so at this point,the upper80and lower83part of the needle hub It acts like the interface tube and the transmission of the remaining liquids from thesecond chamber 3to thefirst chamber 2is performed through the needle hub.

[0097] In other words, the contents of thesecond chamber 3enters the dispensing hub through perforations of the lower part 84of the hub, thenthe liquid is removed from perforations of the upper part 80of the hub, and so the liquid istransferred 84,85to thefirstchamber 2.

[0098] As shown in the cross section of-9, in the following, the needlepenetratesthe septum 104and enters the adapter’sinterstitial space 31, and with this stage the collapsing iscompleted 17.

[0099] The next step is drawing the liquid medicine from the vial into a syringe. so that, After removing the sheath house 13, firstthe lid cap 43of the vial head is opened87and the coatings arepushed 86aside, and thenthe syringe tip 28, in the direction of arrows111, is placed in theadapter mouth 72and with the force pressure of the prefers along with the rotation of thefemale luer27of the adapter goes down, and with the moving down of thefemale luer27of the adapter, The needlepenetrates the nose105of thefemale luerand creates astraight path52between the vial and the syringe.

[0100] There arelines 98on the vial body1bare used to measure the volume of liquid in the chambers.Examples

[0101] Consider a scenario where a healthcare professional needs to prepare a medicament for administration to a patient. The medicament is in the form of a powder housed in the first chamber of the mixing vial, and the diluent is in the second chamber.

[0102] This begins by a rotary movement, which opens the screw connection and removes the barrier of movement on the longitudinal axis and continues with a force at the distal end and the proximal of the vial that causes collapsing containers.

[0103] As the collapsing continues, causes the tip of the Interface needle to penetrate the plunger seal, cross the layers, and enter the mixing container chamber. This allows the diluent to be transferred into the mixing container through the Interface needle, where it mixes with the medicament in the first chamber.

[0104] Finally, the needle penetrates the septum and enters the adapter’s interstitial space, completing the collapsing stage. The next step is drawing the liquid medicine from the vial into a syringe.

[0105] After removing the sheath house, the lid cap of the vial head is opened, the coatings are pushed aside, and the syringe tip is placed in the adapter mouth. With the pressure and rotation of the female luer of the adapter, the needle penetrates the nose of the female luer and creates a straight path between the vial and the syringe. Lines on the vial body are used to measure the volume of liquid in the chambers.

[0106] The Multi-Chambered Mixing Vial with Access System and Interface Needle is an invention with wide industrial applicability, particularly in the pharmaceutical and healthcare sectors. It can be used in the production of medications, ensuring their stability and efficacy. The design of the vial allows for easy and safe preparation and administration of medications in healthcare facilities and home settings. It also has potential use in veterinary medicine.

Claims

A multi-chambered mixing vial for storing and mixing pharmaceutical compositions, comprising:a) a mixing container having a first end and a second end, the first end being closed by an elastomeric stopper and the second end being sealed by a plunger seal, the mixing container defining a first chamber of fixed volume between the stopper and the plunger seal, the first chamber containing a pharmaceutical composition;b) a supplemental container having a closed bottom and an open top, the supplemental container being slidably mounted to the second end of the mixing container and defining a second chamber of variable volume between the bottom and the plunger seal, the second chamber containing a liquid component;c) a floating balloon disposed within the first chamber, the floating balloon having a navel and multiple internal chambers containing medicaments, the floating balloon being movable within the first chamber due to a pressure difference between the first and second chambers and being capable of forming a hermetic seal with the inner wall of the mixing container;d) An interface needle having a shaft, a hub, and a connecting flange, the interface needle being positioned within the supplemental container along the longitudinal axis of the vial and configured to pierce the seals and transferring fluids between chambers, allowing fluid to pass through it;e) An access system comprising a cylindrical holder insert positioned in the elastomeric stopper and a female luer insert positioned in the bottom insert, the access system being configured to permit a needleless syringe to access the medical fluid in the vial.The multi-chambered mixing vial of claim 1, wherein upon slid and collapsing the mixing container and the supplemental container towards one another, the interface needle pierces the plunger seal and enters the first chamber, causing the liquid component in the second chamber to be transferred and flow into the first chamber through the Interface needle.The multi-chambered mixing vial of claim 1-2, wherein upon further collapsing the containers, the interface needle pierces the navel of the floating balloon, causing the fluid contents in the internal chambers of the floating balloon to leak and mix with the medical contents in the first chamber.The multi-chambered mixing vial of claim 1-3, wherein upon further collapsing the mixing container and the supplemental container towards one another, the interface needle perforates the floating balloon and reaches the elastomeric stopper.The multi-chambered mixing vial of claim 1-4, wherein when the interface needle reaches the stopper, the upper part of the hub enters the first chamber, while the lower part of the hub is located in the second chamber, and wherein the hub acts as an interface tube that transfers the remaining liquid component in the second chamber to the first chamber.The multi-chambered mixing vial of claim 1, wherein the process of mixing involves collapsing the mixing and supplemental containers towards one another, from a pre-mixed condition to a post-mixed condition, which starts with a chosen rotary movement using threads, this movement opens the screw connection and removes the barrier of movement on the longitudinal axis.The multi-chambered mixing vial of claim 1-5, wherein by reached collapsing the containers to the final stage, the needle penetrates the septum of the stopper and enters the adapter’s interstitial space.The multi-chambered mixing vial of claim 1-7, wherein the tip of the needle enters the interstitial space simultaneously with the completed and end of collapsing the containers.The multi-chambered mixing vial of claim 1, wherein the floating balloon is a cylindrical piston having bubble chambers and an abdominal chamber filled with medicinal liquids, that all chambers attached to a navel by ducts, the navel located in the central space of the floating balloon, and has gaskets On the outer margin that are in contact with the inner wall of the container and sealing and facilitate the movement of the floating balloon inside the tube;The multi-chambered mixing vial of claim 1, the stopper comprises the extrusion lines having a penetrable texture, which provides easy penetrability to a needle and enabling access to the contents of the inner space of the vial by penetrating the needle tip when the user wants to withdraw the contents of the vial using the needle.The multi-chambered mixing vial of claim 10, the extrusion line can act as a one-way air filter and allow the air to exit the vial, after the lid was removed.The multi-chambered mixing vial of claim 1, wherein the female luer insert, slideably positioned in the cylindrical cavity of a cylindrical holder insert.The multi-chambered mixing vial of claim 1, wherein the lower end of the access system is closed and seals by an insole septum.The multi-chambered mixing vial of claim 1, wherein the female luer is a cylindrical hollow insert, insert, slideably positioned in the cylindrical cavity of a cylindrical holder insert, and comprising: A exit port, which is also as a connecting opening, for connection to the tip of the syringe; A lock skirt that is placed inside the annular cylindrical groove of the holder piece; A head having a nose that has a pierceable cap to allow the needle tip to pierce the nose, and having a neck that the edges of the neck have lateral pores.The multi-chambered mixing vial of claim 1, wherein The access adapter has two modes of use including return valve position mode and non-return valve position mode.The multi-chambered mixing vial of claim 15, wherein in the first position by applying the initial force pressure, the female luer comes down to the extent that the middle teeth on the body of the lock skirt are involved with the edges of the annular groove, and this conflict restricts the continuation of the female luer's downward movement except by the secondary pressure.The multi-chambered mixing vial of claim 15, wherein the female luer in the first position acts as a movable return valve, such that upon an initial external force pressure is applied, the female luer insert moves downward to first position and an limited access path is created through the lateral ports, and when the pressure is removed, the spring is released and the top insert returns to its previous state, thereby closing the limited access path.The multi-chambered mixing vial of claim 15, wherein the female luer in the second position acts as a non-return fixed valve, such that after the initial pressure, upon applicate the secondary pressure, the female luer moves downward from a first position to a second position, until the needle tip penetrates the piercability cap and the edges of the head engage with the internal protrusions of the cylindrical holder insert and thus the female luer insert in the non-return valve mode.The multi-chambered mixing vial of claim 15-18, wherein when the edges of the head engage with the internal protrusions causes blocked the path of these port, thus the female luer is in the non-return valve mode.The multi-chambered mixing vial of claim 1, wherein an interface needle configured to use to pierces: the plunger seal, the navel of the floating balloon, the insole septum of the stopper and the cap of the nose.The multi-chambered mixing vial of claim 1, when withdrawal the liquid contents of the first chamber of the vial by the syringe, the liquid contents from the upper holes of the hub to the interior down of the hub and then dragged to the vial adapter via the hollow shaft of the needle.The multi-chambered mixing vial of claim 1, wherein the perforated hub is a swollen hollow rod of the needle whose leads from the top to the shaft and the bottom to the flange and having the side perforations and has a guide sleeve is disposed inside the upper half of the hub dotted bulge, and the fluids that penetrate into the dispensing reservoir of the hub through the perforations are directed by the guide sleeve towards downward and then into inlet of the hollow rod in the reservoir of the hub.The multi-chambered mixing vial of claim 1, wherein the diameter of the hub part of the hollow needle is larger than the diameter of the rod part of the needle body and the length of the hub is longer than the thickness of the central axis of the plunger seal.The multi-chambered mixing vial of claim 1, wherein when the vial collapsing is completed, the perforations of the upper part of the hub are open inside the first chamber, and the perforations of the lower part of the hub are blocked by the mantle of the plunger seal.The multi-chambered mixing vial of claim 1, wherein the needle can be made of coated stainless steel or any material that has enough strength and does not react with liquids and pharmaceutical contents.The multi-chambered mixing vial of claim 1, wherein the mixing container and supplemental receptacle are preferably glass or a pharmaceutically compatible plastic; the sheath house is preferably made of polycarbonate.The multi-chambered mixing vial of claim 1, wherein a small hole is located at the center of the lower end of the supplementary container, which is sealed by a tipped cover, this cover is penetrable by the needle tip, thus providing access to the contents of the second chamber by a Belone connector.The multi-chambered mixing vial of claim 1, wherein the end of the supplementary container has a location for a Belone connector has a short needle with a sharp tip, which provides access to the contents of the second chamber using a needleless syringe, In this way, by placing the syringe tip and pressing inward, the sharp tip of the Belone connector pierces the tipped cover of the end of the supplementary container and enters the interior space of the needle hub.The multi-chambered mixing vial of claim 1, wherein The Belone connector has a structure and components similar to the access system, except that it has a piercing spike instead of a permeable nose.

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