SINGLE-USE, NEEDLE-FREE, CHANNEL-BASED, CONICAL GLASS MEDICINE VIAL STOPPER.

Abstract

The invention relates to a stopper fitted to the neck of glass vials used in pharmaceutical administration, which can contain liquid or powder medication. The invention maintains the sterility of the medication contained in glass pharmaceutical vials until use, and provides a needle-free access method for both reconstitution (in powder form) and withdrawal of liquid / reconstituted medication when healthcare professionals wish to use it. During the reconstitution of the powdered medicine in the vial, the channeled structure of the invention directs the diluent to flow downwards from the glass surface of the vial. This direction reduces the foaming of the medicine or its sticking to the bottom of the bottle. The conical structure of the invention ensures that the medicine is collected at a single point when the vial is held upside down to draw the liquid medicine into the syringe, facilitating the drawing of the correct dose of medicine into the syringe.

Description

1 TARIFF SINGLE-USE, NEEDLE-FREE ENTRY AREA, CHANNEL-BASED AND CONICAL GLASS MEDICINE CONTAINER. STOPPER OF THE FLAKO TECHNICAL FIELD The invention in question is used within the scope of pharmaceutical administration and contains liquid or powdered drugs. This relates to the stoppers on glass vials of medicines that may contain certain substances. The invention enables the maintenance of sterility of medicine contained in glass pharmaceutical vials until use. When the medicine is to be used by healthcare personnel, it needs to be diluted (powder). (for medications in this form) and for drawing liquid / diluted medication into the vial without a needle. It offers the possibility of using a diluent for powdered medicines in 10°C. The invention directs the liquid to flow down the glass surface of the vial. Its channeled and conical structure ensures that the medication is distributed to a single point when the vial is held upside down. It facilitates the collection of the medication, making it easier to draw the correct dose into the syringe. STATE OF THE ART 15 This invention is used by healthcare professionals in the treatment and care process within the healthcare field. It is a component of a commonly used medical product (glass medicine vial). Therefore The invention is technically related to the field of health. The invention covers the entire process from the production to the use of medicines in glass vials. While preserving it, healthcare personnel can add 20 grams of the medication to the vial when they want to use it. It allows the patient to reach the medication without a needle and draw the exact dose into the syringe. Glass vials contain medicines in liquid or powder form. For medications in powder form, injections are required for administration to individuals receiving healthcare services. dilution with water / isotonic liquid (0.9% NaCl solution) and after dilution, injecting with a syringe needle. It needs to be drawn into the syringe using a similar method. Similarly, glass containers 25 containing the drug in liquid form... The medication must also be drawn from the vials into a syringe using a syringe needle. (Potter et al., 2023). In the process of reconstituted and withdrawn powdered medications from glass vials: -The needle cap is opened to draw the liquid from the ampoule containing the diluent next to the vial, the liquid If there is air in the syringe after drawing, remove the needle cap 30 before dispensing it into the vial. 2 The syringe is closed and the air is removed, then the needle cap is opened again and the rubber vial stopper is applied. The bottle is punctured with a needle, liquid is injected into it, and after the liquid is injected, the needle cap is closed again. The needle is closed. During this process, the needle is opened repeatedly to maintain its sterility and to clean the needle. Storing the reinstalled cap aseptically becomes difficult. - Administering the diluent through a needle at a single point inside the bottle causes the medication to foam. 5 It is possible. -To draw the diluted medicine with a needle, the pressure inside the vial needs to be adjusted. The amount of liquid added to the bottle to dilute the powdered medicine before starting the liquid extraction process. Air needs to be introduced into the vial. This air will be released into the liquid when the medication is drawn up. The pill, once in its final form, is collected and pushed into the syringe. Therefore, the pill is drawn from the vial in 10 seconds. When drawing the liquid, the tip of the needle should be kept at the very end to avoid drawing air from the vial into the syringe along with the liquid. ensuring that part of the medication remains constantly within the liquid medication in the vial, thus maintaining the medication level. As the amount of medication decreases, it is necessary to withdraw the needle in a coordinated manner, drawing all the medication into the syringe. This Because the procedure requires fine psychomotor skills and hand-eye coordination, the syringe... If air is also drawn in along with the medicine, this air must be removed without causing the medicine to leak out. 15 It is necessary. However, if the medication is released with air, it will cause a dose loss. -Fine psychomotor skills and hand-eye coordination develop with experience, For healthcare personnel with little experience and students actively participating in the procedure, during this process It is possible to lose all of the medication or lose a dose of the medication. -The needle tip has an angled cut structure to achieve maximum sharpness, this 20 The situation is that if the needle tip is held vertically inside the vial, the medication will be fully dispensed from the vial. This can prevent the medication from being drawn. Therefore, in order to draw the full dose of medication from the vial, To direct the remaining medication to the bottom of the bottle, use the needle tip to draw up the medication. A slight tilt is required at this stage. This process requires coordinated and delicate skill. This requires re-inserting the needle to draw up the medication, as it may come out of the vial during the procedure. This is necessary, and this process makes the procedure difficult for healthcare personnel. The high volume of patients in healthcare institutions... Considering treatment practices and patient-to-nurse ratios, for nurses... Drawing medication from a vial using a needle is not practical or time-efficient. -Repeatedly inserting the needle into the vial poses a risk of puncture wounds. Abdo In the study by Almoliky et al. (2024), needle stick injuries were the most common injury among nurses. The reason for the injury was that the fingers were the most frequently injured area (62.77%). It has been determined. 3 In the process of drawing up liquid medications from glass vials: -Except for the dilution step, all the substances mentioned above are withdrawn from the vial of liquid medicines. This also applies to the process. Also, when drawing the medicine from the glass vial, the needle at the tip of the syringe should be used to hold the rubber stopper / cap on the vial. The needle is punctured and access is gained to the vial. During this stage, the needle tip deforms while piercing the rubber stopper. 5 (its very tip loses its sharp and pointed characteristic) and the drug enters the tissue. In applications (subcutaneous and intramuscular drug administration), a deformed needle tip may penetrate living tissue. It will cause trauma at the insertion point and pain because the surface comes into contact with the medication when drawing it from the vial. Because of this, the needle tip needs to be replaced with a new one. Therefore, the medication in the vial needs to be removed with the needle. Drawing the material into the syringe using the tip, increasing the number of procedural steps, requires additional material. This leads to excessive use and waste production. This situation violates environmental sustainability principles (limited (effective use of medicinal products produced from natural resources and waste management) This is one of the main issues being fought over. Based on this, the invention in question involves dispensing powdered or liquid medicines into vials without the use of a needle. It offers entry possibilities and the number of materials and process steps used during the process is 15. by reducing and effectively using materials and time, reducing the likelihood of sharp and penetrating injuries, and It allows for more practical and precise dose withdrawal of medications. A search was conducted on Espacenet and the Turkish Patent and Trademark Office websites to find similar inventions. No inventions similar in design to the invention in question have been encountered, and the invention in question... It was designed for one of the stated purposes (needleless entry), but the design flaws are 20 as a completely different, useful 1996 device called "Disposable needleless vial cap". There is a model application. The invention mentioned in application number TR 1996 / 00845, due to its purposeful similarity, only concerns the rubber of the vial. It consists of creating an opening in the stopper through which the syringe can be inserted without a needle. This opening... While it can assist in the process of injecting and withdrawing liquid into the vial, due to a design flaw, 25 Therefore, the fluid accumulating at the edges of the opening will not facilitate the removal of the fluid; on the contrary, the vial This will make it difficult to fully drain the liquid inside. Also, the gap created in the rubber stopper, This can cause drug leakage from the vial and compromise the sterility of the medication. Regarding these issues... No explanation is provided for the invention mentioned. Furthermore, on the Turkish Patent Office's website, it states "30 that can be used with vial caps of different sizes." needleless valve vial adapter" 4 In application number TR 2007 / 04836, the adapter is used for needleless liquid transfer into vials. It is designed to provide a connection possibility. The adapter in question is a separate part independent of the vial. This involves the production of additional materials for the process, sterilization and separate packaging of this part, and During the procedure, healthcare personnel must use this part in accordance with aseptic techniques. This requires training in this area. Therefore, the health sector needs to be educated on environmental sustainability. By serving the opposite purpose of development in terms of scale, it promotes the use of disposable resources. It increases [the effect of this]. Additionally, this extra adapter has a tip that pierces the rubber stopper of the vial and enters the vial. This section has a specific length, similar to inserting a needle into the vial. Therefore... When the liquid level inside the vial drops below the height of this tip, this adapter... It may not be able to completely draw out the remaining liquid in the vial. Marks (2014)' 10 In the study, when drawing medication from the vial using an adapter, the remaining medication in the vial... It is recommended that efforts be made to reduce the amount. The advantages of the invention: The invention in question is (a channeled and conical glass medicine cabinet with a disposable needle-free entry area). (vial stopper), performing the process of injecting and withdrawing liquid into the vial without a needle. 15 In addition to providing this, its channeled structure allows the powdered medicine inside the vial to be transferred into the liquid without foaming. its conical structure causes the liquid to collect at one point when withdrawing the medication, ensuring the full dose of the drug. This facilitates the withdrawal of fluid. When the vial is inverted to withdraw the fluid, the fluid is initially drawn out. The fluid can be drawn into the syringe via the channeled structure of the stopper, at the level of the fluid channel opening. When it remains below, it collects inside the conical structure, and the hole at the tip of the conical structure is 20 Through this mechanism, the entire liquid can be directed into the syringe. Therefore, this structure allows the medication to be drawn from the vial into the syringe. during extraction, aseptic technique is maintained and drug leakage is prevented, ensuring the full dose of medication is drawn. It is helpful. At the same time, the approximate volume of diluent liquid in the vials during the production phase. Air is released for 25 minutes after the diluent solution is injected into the vial, before the needle is removed. It is requested that this air be allowed to enter the syringe; if this step is skipped, the needle will malfunction. When removed, the air inside the vial escapes through the punctured area along with the drug residue, causing health problems. It is possible for the substance to be sprayed onto the personnel in the form of tiny, invisible particles. However, the injector-compatible existing opening at the end of the stopper belonging to the invention in question, vial When the protective plastic cover is removed, it will release the air. Therefore, needleless 30 This invention, which offers an entry possibility, is based on the air pressure inside the vial, enabling healthcare personnel to... It reduces the likelihood of unwanted contact with the drug. This invention utilizes rubber-plastic materials that many manufacturers currently use in their production processes. It only requires the production of a different stopper in terms of design, and the production of this stopper This stage requires placing the vial into the bottle. Therefore, it requires additional steps for manufacturers. Raw material sourcing does not involve an additional sterilization or packaging step, It does not impose any additional financial burden. 5 THE PURPOSE OF THE INVENTION The invention in question is primarily intended for the delivery of powdered or liquid medication in glass drug vials without a needle. by providing access to draw the medicine from the bottle into the syringe at the exact dose without foaming it. It aims to... 10 The secondary purpose of the invention is to achieve the primary purpose through the use of additional materials / process steps. time - the need to receive training on a new material - without causing waste production and By reducing the risk of puncture wounds, healthcare professionals can easily draw medication from the vial. It is about maintaining the current workflow. With the invention; 15 Disadvantages eliminated by the invention ✓ Inserting a syringe needle into a glass medicine vial to dilute and withdraw the medication. Due to the repeated opening and closing motion during the process, the inside of the needle cap and the needle itself... It requires maintaining its sterility. ✓ Inserting a syringe needle into a glass medicine vial is a procedure that healthcare professionals must perform for 20 years. The sharp instrument poses a risk of injury. ✓ When drawing medication from vials containing powder, the rubber vial stopper must be removed multiple times. piercing (for delivering the diluent liquid for powdered medicines and for drawing out the diluted medicine) (separately) requires. The rubber stopper must be cut or pointed at the tip of the needle during the piercing process. the tip can cause the rubber stopper to tear or a piece to break off from the stopper 25 It is possible (a piece of microplastic may also fall into the medicine, but microplastics are not visible to the naked eye). This situation occurs when the vial is inverted to deform the liquid medicine before it is drawn into the syringe. leakage of medication from the stopper, loss of dosage, contamination of the medication or the formation of an embolism in the patient due to microplastic contamination of the medication can cause. 30 6 ✓ (For powdered medicines) The injector needle is used directly onto the powdered medicine inside the vial. The medication may foam during the administration of the diluent solution. Pour the liquefied medication into the syringe. When pulling, the foaming part cannot be pulled out, which leads to a loss of dose. It is able to provide. ✓ Due to the sharp, pointed tip of the syringe needle, 5% of the liquid medicine in the vial... It is difficult to draw the full dose when using a syringe needle. ✓ A separately packaged additional part kit that enables needle-free insertion into glass pharmaceutical vials. (vial adapters) are an additional step for healthcare personnel performing the procedure. This step results in additional processing time and waste generation. ✓ The approximate volume of diluent liquid in glass vials during the production phase is 10 The air trapped inside the rubber stopper escaped through the punctured area and landed on the medical personnel. It can splatter drug residue in the form of tiny particles invisible to the naked eye. ✓ Transferring medication between vials and syringes using a vial adapter. This in itself requires the production of an additional material for manufacturers. ✓ When using a needle during the process of diluting or drawing up medication from a vial, the needle tip should be 15 because the needle had lost its sharpness and was contaminated with medication, the patient was given the medication. When administering an injection, the needle tip should be replaced with a new one. is required. ✓ The invention provides access to the drug in the vial using a needle-free entry point. When healthcare personnel access the medication in the vial using a syringe needle, 20 It reduces the risk of possible sharp instrument injuries. ✓ The invention describes the process of releasing medication from a vial through an opening created in the stopper during the manufacturing process. It provides access without needle penetration. Therefore, in the rubber stopper... Rupture, fragmentation, and embolism in the patient caused by the detached fragment within the liquefied medication. It eliminates the risk of creating [the problem]. 25 ✓ The invention allows for needle-free entry into the vial, preventing deformation of the vial stopper. Because it didn't dispense, when the vial was inverted and the liquid medicine was attempted to be drawn into the syringe, the medicine came out. It prevents leakage, dose loss, and drug contamination. ✓ The invention's channel structure allows the diluent liquid to flow down from the outer surface of the vial. It is directed to flow correctly, and this flow causes the medicine to foam. 30 It prevents. ✓ Thanks to the conical structure of the invention, the medication inside the vial is delivered to the center of the stopper in a single unit. By directing the needle to a specific point, the medication can be drawn into the syringe at the correct dose. 7 ✓ The features of the invention will be implemented during the production phase of the drug vial. Because of its nature, healthcare personnel may require additional procedural steps, additional materials, and additional procedure time. Continue the current practice of drawing medication from the vial without needing to use it. This allows for the creation of no additional waste, thus protecting the environment. Sustainability is taken into consideration. 5 ✓ The invention concerns the injector-compatible existing opening at the tip of the stopper, vial When the protective plastic cover is removed, it will release this air. Therefore... Air pressure inside the vial can cause adverse reactions from healthcare personnel regarding the medication. The likelihood of contact will decrease. ✓ The invention uses rubber-plastic 10, which many manufacturers currently use in vial production. This requires producing a stopper that differs only in design from the material, and this The stopper needs to be placed inside the vial bottle during the production phase. Therefore, for manufacturers, this requires additional raw material supply, additional sterilization, or packaging. It does not involve any additional stages and does not impose any financial burden. ✓ The invention concerns the injector-compatible existing opening at the tip of the stopper, needle 15 Administering the diluent into the vial without using a needle (because the needle stopper did not pierce the vial) (the sharpness of the tip is not impaired) and the drawing of the medicine into the syringe (the needle with the medicine (contamination is prevented) it offers the possibility of delivering the medicine to the patient. During the injection process, the needle tip that comes out next to the syringe It does not need to be replaced with a new one. This situation reduces the use of additional resources, costs, 20 It reduces waste production. DESCRIPTION OF THE FIGURES Figure 1: View of a channeled and conical glass drug vial stopper inside the vial. Figure 2: View of a channeled and conical glass drug vial stopper. 25 EXPLANATION OF REFERENCES IN THE FIGURES 1. Plastic outer cover 2. Aluminum clip 3. Stopper entry 30 4. Liquid accumulation area 8 5. Liquid transmission line 6. Channelled and conical stopper body. 7. The concave surface of the canal. 8. The convex surface of the canal. 9. Circular opening 5 10. Glass vial bottle EXPLANATION OF THE INVENTION The invention in question concerns the external environment of a channeled and conical glass pharmaceutical vial stopper, which is the subject of the invention. a plastic outer cap (1) that prevents contact with the glass vial, and a stopper that secures the glass vial to the neck. aluminum clip (2), with injector tip structure through which the vial bottle and injector connection can be established. Compatible stopper inlet (3), fluid accumulation area responsible for fluid transfer between syringe and vial (4), transferring the fluid from the fluid accumulation area into the vial or transferring the fluid from the vial into the syringe conveying liquid transmission line (5), channeled and conical stopper through which the liquid passing through the transmission line progresses The body (6) should be placed on the outer surface of the vial to dispense the diluent liquid into the vial bottle. The stopper body, which will guide it correctly, is positioned at the three, six, nine, and twelve o'clock positions on the clock face. The concave face of four channels, ¾ ​​the length of the convex face (7), bottle When drawing fluid from the vial into a syringe, holding the vial upside down causes the fluid to flow into the fluid delivery line. The four channels that guide the clock are positioned at the three, six, nine, and twelve o'clock positions, with no gaps in between. The convex surface extending to the outer surface of the glass vial bottle without any gap (8), vial 20 When drawing liquid from a bottle into a syringe, the vial is held upside down, resulting in a channeled and conical shape. The conical section at the midpoint of the stopper body allows the remaining fluid to be drawn into the syringe. It consists of a circular opening (9) located at the upper pointed point of the structure. The channeled structure that is the subject of the invention and conical stopper on the neck of the glass vial bottle (10) containing liquid or powder medicine. It contains. The aforementioned vial bottle (10) is made of glass. The said stopper 25 (stopper inlet (3), fluid accumulation area (4), fluid transmission line (5); concave surface of the channel (7), outer surface of the channel a whole with the stopper body (6) which has a convex face (8) and circular opening (9) on it. (as) is made of plastic. The stopper (stopper inlet (3), liquid accumulation area) which is the subject of the invention (4), liquid transmission line (5); concave face of the channel (7), convex face of the channel (8) and circular opening (9) For the design of the stopper body (6) and the glass vial bottle (10) containing any 30 There is no size / volume preference. This is because the dimensions of glass vials in the healthcare system are not specified. (Length, diameter, etc.) vary, therefore the neck of glass vials with varying dimensions also changes. 9 The design features of the stopper, whose parts are described above in order, are preserved while the parts are modified. Stoppers can be produced in various sizes. For glass vials containing powdered medicine, the following procedures apply in order: -Stopper inlet (3) is compatible with injector plug and injector connection is needleless 5 is being carried out. -After the injector is attached to the stopper inlet (3), the liquid inside the injector is discharged into the area where the liquid will be discharged. (4) When being discharged, the liquid conveying line (5) conveys the liquid to the channeled-conical stopper body (6). -The liquid conveyed from the liquid conveying line (5) passes through the concave surface of the channels (6) in the stopper body (7) As the syringe moves into the vial, the pushing pressure of the syringe and the acceleration provided by the concave surface cause the vial to 10 It is directed towards the outer surface of the bottle (10). -The liquid flowing from the concave surface of the channels (7) into the vial contains the medicine in the vial bottle (10). It dilutes it. -The diluted medicine passes through the convex surface of the channels (8) when the vial bottle (10) is turned upside down. It is directed to the liquid transmission line (5). 15 -The liquid directed to the liquid transmission line (5) is drawn into the injector attached to the stopper inlet (3). For glass vials containing liquid medicine, the following procedures apply in order: -Stopper inlet (3) is compatible with injector plug and injector connection is needleless. is being carried out. -Liquid medicine is delivered through the convex surface of the channels (8) when the vial bottle (10) is turned upside down. It is directed to the transmission line (5). -The liquid directed to the liquid transmission line (5) is drawn into the injector attached to the stopper inlet (3). HOW THE INVENTION WAS APPLIED TO INDUSTRY This invention provides pharmaceutical companies with 25% of the industry experience during the production of glass vials of medicine. It is feasible. After the production phase, the application area of ​​the invention in question... These are all healthcare institutions at the first, second, and third levels. (In glass vials / bottles) Drugs are frequently administered as part of parenteral drug administration in healthcare settings. This is the form of medication used.

Claims

11 REQUESTS 1. The invention relates to devices used in pharmaceutical administration that may contain liquid or powdered drugs. This relates to the stopper placed on the neck of glass medicine bottles in vial form; its characteristic is the vial. the bottom of the cylindrical syringe tip (jug) that allows access to the medication without a needle Circular stopper inlet (3) compatible with circular base, circular stopper inlet (3) 5 the diluent solution is administered into the vial via the attached syringe, or the solution is drawn into the syringe. The circular structure where the liquefied / liquid medicine will accumulate is located between the stopper inlet (3) and the liquid conveying line (5). the area of ​​liquid accumulation in the cone structure (4), from this accumulation area in the cone structure (4) is given by the injector the dilution solution passes into the vial or the liquefied / liquid medicine from the vial passes into the syringe. The bottom and top bases that provide a connection between the liquid accumulation area (4) and the stopper body (6) for this purpose. The circular, vertically cylindrical liquid delivery line (5) is used to deliver the dilution into the vial via syringe. three, six o'clock, directing the liquid towards the outer surface of the glass vial while the vial is positioned vertically on the ground. positioned at the nine and twelve o'clock positions and concave with a length equal to ¾ of the length of the convex surface. to the faces (7), the liquid medicine in the vial is transferred to the liquid delivery line (5) when the vial is turned upside down The guiding clock is positioned at three, six, nine, and twelve o'clock with no gaps in between. The glass vial has four channels with convex surfaces (8) that extend to the outer surface of the bottle and conical structure of the stopper body (6) containing a circular opening (9) at the upper pointed point. It includes a structural stopper body (6).

2. According to Claim 1, a disposable, needleless entry port, channeled and conical glass medicine container 20 It is a vial stopper, and its characteristic feature is that it is the outer stopper of the channeled and conical glass drug vial that is the subject of the invention. It has a plastic circular outer cover (1) that prevents contact with the environment.

3. A channeled and conical glass medicine capsule with a needleless entry point, according to Claim 1. It is a vial stopper, and its feature is that it secures the stopper to the neck of the glass vial bottle. It has a clip (2).

4. A channeled and conical glass medicine capsule with a needleless entry area, according to Claim 1. It is a vial stopper, and its function is to enable the connection between the vial bottle and the syringe. It has a stopper entry (3) compatible with the end structure. 30 5. A channeled and conical glass medicine capsule with a needleless entry point, according to Claim 1. It is a vial stopper, a conical liquid stopper that facilitates fluid transfer between the syringe and the vial. It has an accumulation area (4). 35 12 6. A channeled and conical glass medicine capsule with a needleless entry area, according to Claim 1. It is a vial stopper, and its function is to transfer the fluid from the fluid accumulation area into the vial or to stop the vial. a cylindrical liquid with circular top and bottom bases that allows the liquid inside to be delivered to the syringe It has a transmission line (5).

7. A channeled and conical glass medicine capsule with a needleless entry point, according to Claim 1. It is a vial stopper, characterized by its channeled and conical shape, which allows the fluid to move through the delivery line. It has a built-in stopper body (6).

8. According to Claim 1, a disposable, needleless entry port, channeled and conical glass medicine container 10 It is a vial stopper, and its function is to transfer the diluent liquid into the vial during the dispensing process. the stopper body, which will point towards the outside of the bottle, at the three, six, nine, and twelve o'clock positions. positioned and four channels, each ¾ the length of the convex surface, on the concave surface. (7) is having.

9. A channeled and conical glass medicine capsule with a needleless entry area, according to Claim 1. The vial stopper is the feature of which is that the liquid transfer of the diluted medicine when the vial bottle (10) is turned upside down. positioned at three, six, nine and twelve o'clock, which directs it to the line (5), with no in between four convex surfaces that extend to the outer surface of the glass vial bottle without leaving any gaps (8) is having. 20 10. According to Claim 1, a disposable, needleless entry port, channeled and conical glass medicine container. It is a vial stopper, and its function is to hold the vial upside down when drawing liquid from the vial into the syringe. When held, the liquid remaining at the midpoint of the channeled and conical stopper body flows into the syringe. The conical stopper body, which allows for its pulling, has a circular opening at its pointed top point, 25 (9) is having.

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