JP2006175199A - Fluid dispenser - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a fluid dispenser, maintaining microbiological safety without causing a problem of compatibility and preventing generation of reproducing material. <P>SOLUTION: This fluid dispenser incorporating at least one material being capable of interacting via an oligodynamically active substance, includes: a metering pump; an inlet valve 26 and an outlet valve 22, wherein the fluid coming into contact with at least one oligodynamically active substance is present the region of the outlet valve 22, and inlet region to the outlet valve 22 and/or outflow region from the outlet valve 22. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a fluid dispenser for aseptic fluid.

  Non-Patent Document 1 describes a fluid dispenser that has the form of a drop pipette and is attached to a container containing eye drops. Inside the dropping pipette is silver or sparingly soluble so that airborne pathogens that are aspirated with droplets returning into the container must pass through the antimicrobial (micro-action) active silver layer before entering the container. A silver coating made of a silver salt is arranged. It is also stated that a 9 mm diameter ceramic ring embedded with silver chloride has been found suitable. These ceramic rings can be securely mounted by simply pushing them into any conventional type of pharmaceutical, eye dropper. This method of introducing the silver coating into the dropper is that only the droplet returning along the wall of the dropper is in contact with the silver coating and is used in the normal manner with the dropper facing downwards. The liquid portion inside the fluid column that flows back from the vessel into the container has the disadvantage that it does not contact. For this reason, every time the eye drop container is used, the eye drop is contaminated. A further disadvantage is that since the interior of the container is in contact with the ambient air via the dropper, pathogens always enter the container, even when not in use, resulting in contamination of the eye drops in the container.

Patent Document 1 discloses a fluid dispenser for an aseptic fluid that connects a fluid inlet opening and a fluid discharge opening, and includes a through-passage having a trace action antibacterial active substance therein. It is. The device includes a metering pump, an inlet valve and an outlet valve. In the area of the inlet valve and / or outlet valve, there is a microactive bactericidal active substance. According to FIG. 1 of this document, a silver coatable spring is shown. Similarly, a valve ball that functions as an inlet valve is made of corundum in which a silver material is embedded as an effective substance for a small amount of action. The disadvantage of this device is that compatibility problems often arise due to the presence of silver and oxidation processes that generate unwanted by-products, and it is often the limited choice of suitable formulations. Bring.
German Patent No. 4027320C2 specification German Patent Application Publication No. 01128625A1 Pharmaceutische Zeitung, 124, No. 20, pages 949 and 950, May 17, 1979.

  One aspect of the present invention is to provide a fluid dispenser of the kind as mentioned in US Pat. No. 6,057,056, and the fluid dispenser does not cause compatibility problems and It prevents the formation of by-products while simultaneously maintaining sufficient and comparable microbiological safety (ie germ-free application).

  The invention relates to an inlet opening for a fluid contained in a supply container made of a flexible material, and at least one microactive substance for dispensing the liquid and in contact with the fluid therein A through-passage connecting the discharge opening, which operates without air pressure compensation, so that no pressure compensation occurs in the vessel through the inflow of air during operation, the pump comprising: A metering pump including spring means for contacting the fluid, an inlet valve for closing the inlet opening, and an outlet valve, and an outlet that is part of the through passage leading from the outlet valve to the discharge opening A fluid dispenser for sterile fluid, comprising a silver, silver salt, other silver compound, alloy and metal or salt form or these nanomers as these compounds Through the oligodynamic material selected from relates sterile fluid fluid dispenser provided above the outlet passage decontamination means comprising a material having the ability to interact with pathogens.

  The invention further relates to the use of the fluid dispenser of the invention. The fluid dispenser of the present invention is suitable for dispensing trace amounts of liquids in various fields such as pharmaceuticals, cosmetics and medical devices. The liquid is usually applied topically. Suitable liquids are ophthalmic compositions and nasal compositions.

  The term “interact” is to be defined in the present invention as a kind of surface reaction. The theory is that the interaction occurs near or preferably on the surface of the material that has the ability to interact with pathogenic bacteria contained in the liquid. The pathogen here can be derived from contamination of the unprotected outer part of the discharge opening in contact with the surrounding environment. Pathogens here can be contained in fluids, ie in other substances that come into contact with fluid dispensers such as air, tears, mucous membranes and the like. One possible mechanism is that contaminated liquids come into contact with ions derived from metal oxides formed directly on the surface of the material. This contact provides an antibacterial effect. Regarding the relationship between the surface of the material and its size, there is a general rule that the larger the surface, the higher the decontamination effect. Here, different levels of interaction with pathogenic bacteria can occur. For example, the interaction can result in slowing or stopping the growth of pathogenic bacteria in the fluid. A strong level of interaction is, for example, a micro-acting effect in which a micro-acting active substance actually kills pathogenic bacteria in the fluid.

  According to the fluid dispenser of the present invention, the decontamination means is provided at the outlet passage, preferably at the top of the outlet passage. The term “upper” further includes the area of the exit passage where optimal decontamination can be ensured.

  According to the invention, a particularly powerful sterilization action results from the position of the outlet valve and the decontamination means. Due to the unique technical configuration, the movable outlet valve does not come into contact with the surrounding environment, which results in a reduced risk of contamination during operation of the outlet valve. As a result, a trace active substance must be provided outside the outlet valve, which is realized by means of decontamination. Furthermore, according to this configuration, the fluid in the container is not always in contact with the microactive substance, which reduces the above-mentioned undesirable reaction of the fluid with the microactive substance. The metering pump operates without air pressure compensation, thereby preventing contamination of the fluid supply due to air flowing into the container for pressure compensation in conventional metering pump operation. The fluid dispenser of the present invention ensures that the fluid in the supply container remains sterile even in use, thereby adding preservatives and introducing trace active substances into other areas of the container There is no need to do.

  Microactive substances are placed in or near the exit passageway to prevent microbial contamination by reducing the number of pathogenic bacteria that can arise from the surrounding environment.

  The material and components of the metering pump and container that are in contact with the fluid may be any type of component and material that is compatible with each fluid. In some applications, metering pumps and containers do not need to be provided with any material capable of interacting with pathogenic bacteria. However, in other applications, it may be advantageous to use materials capable of interacting with pathogenic bacteria in metering pumps and containers. For example, it is advantageous if the inlet valve and / or spring means comprise a material capable of interacting with pathogenic bacteria. Here, the material may be selected from the group consisting of silver, silver salts, other silver compounds, stainless steel and metal or salt forms or these nanomers as these compounds. In this case, the stainless steel may contain at least one element selected from the group consisting of chromium, nickel, molybdenum, copper, tungsten, aluminum, titanium, niobium and tantalum, with the balance being iron as the main component. is there. Of the above materials, all materials containing silver, silver salts or other silver compounds usually have a microactive activity. Stainless steel materials are usually not considered to be microactive, or are considered to be very weak, even if they have microactive activity. However, it is believed that stainless steel material can interact with pathogenic bacteria by slowing or stopping the growth of pathogenic bacteria.

  Preferably, the through passage is always filled with fluid, at least in the region of the inlet valve. More preferably, a trace active substance is provided on the inside of the cap that can be fitted over the fluid dispenser to cover the discharge opening. Here, the cap may be provided with a pin and a hole. Further, a pin may be fitted into the discharge opening located in the head.

  More preferably, the inlet valve further includes a valve seat cooperating with the closure member, wherein the valve seat is provided with a microactive substance. More preferably, the outlet valve further includes a valve seat that cooperates with the closure member. More preferably, the inlet valve is a ball valve, and a valve housing that cooperates with a closing member of the inlet valve is provided, and the valve housing is provided with a trace active substance. Preferably, the outlet valve is a piston valve and is provided with a valve housing that cooperates with a closing member of the outlet valve. More preferably, the decontamination means is made of a material having a circular shape. Here, the decontamination means may be an annular body, a spiral body or a covering material. The material may be a corundum embedded with a trace active compound. Alternatively, the material may be silver.

  Here, as an example, the present invention will be described in detail with reference to one of the drawings showing a longitudinal section of an embodiment of the present invention.

  The fluid dispenser of the present invention does not cause compatibility problems and simultaneously maintains sufficient and comparable microbiological safety of the system (ie, germ-free application). Prevent the formation of by-products.

  As shown in the figure, the apparatus includes a metering pump comprising a cylindrical pump body 1, an operation plunger 2 and a cap 3.

  The pump body 1 comprises a first hollow cylindrical body part 4 shown open at the bottom, a second hollow cylindrical body part 5 of larger diameter, open at the top in the figure (parts). 5 is a part of the operating plunger 2), and a hollow cylinder that is open at both ends and is centrally fixed to the inward annular flange 7 in the transition region between the two parts 4, 5 of the pump body 6 is included. The first body 4 may have an internal thread that is filled with sterile fluid and that can be screwed on the container 9 that is only shown schematically. Alternatively, instead of internal threads, a snap on closure can be used as shown. In order to securely seal between the container 9 and the pump body 4, a sealing portion 11 is provided on the lower side (in the drawing) of the annular flange 7. Near the outlet from the first body part 4 of the pump, the hollow cylinder 6 tapers into a conical shape connecting to a smaller diameter cylindrical valve part 14 leading to the riser pipe, if possible. It has a transition part 12. The open bottom end of the riser forms the metering pump inlet opening 15. Alternatively, as shown, the riser may be omitted.

  The operating plunger 2 has an outer hollow cylindrical portion 17 which is shown in the drawing as being open at the bottom and closed at the top by the head 16 and a hollow inner cylinder extending downwardly from the head 16 to the center. And a shape portion 18. The diameter of the hollow outer cylindrical part 17 is smaller than the diameter of the first pump body part 4.

  A piston 19 fitted into the hollow cylinder 6 and having a through hole 20 is fixed in the inner hollow cylindrical portion 18 at the upper end thereof. The piston valve 21 of the outlet valve 22 fitted inside the hollow cylindrical portion 18 is supported between them by the head 16 via the end of the piston 19 at one end and the spring 23 at the other end. An outlet passage 25 leading to the discharge opening 24 on the head 16 is connected to the inside of the inner hollow cylindrical portion 18 at the position of the piston valve 21.

  The upper part of the outlet passage 25, or preferably the upper part of the outer hollow cylindrical part 17, is composed of nanomers or compounds in the form of silver, silver salts, other silver compounds and their alloys or their metals or salts. A decontamination means 33 comprising a material capable of interacting in the vicinity of the surface via a trace active substance selected from the group is provided. Here, the decontamination means 33 may be provided on the inner and / or outer wall of the outlet passage 25.

  Silver represents the most favorable therapeutic indicator at parts per billion (ppb) concentrations. Depending on the economic problem, the means can be formed of silver, another metal coated with silver, or a material embedded with a microactive bactericidal active substance. In a preferred embodiment of the present invention, the decontamination means 33 has a circular shape such as an annular body or a spiral body. It has been found that corundum can be cited as one convenient material when trace active substances are embedded in the carrier material.

  Further, depending on the configuration and application of the fluid dispenser, the contamination removing means 33 can be provided as a covering material. As an example, the dressing can be disposed on the outer hollow cylindrical portion 17 at the top of the outlet passage 25. A coating material made of silver or a coating material made of a suitable material in which silver or a silver compound is embedded can be provided.

  In the case where a coating material is used in the upper part of the outlet passage 25, it may be appropriate that the silver coating material is a nano-coating material composed of nanomers. For example, a desirable nano-coating material containing silver colloid is described in US Pat.

  As already described, the piston valve 21 that functions as an outlet valve is not located directly at the discharge opening 24. Instead, the piston valve 21 is located in the inner hollow cylindrical portion 18 and is provided with an outlet passage 25 leading from the piston valve 21 to the discharge opening 24. Therefore, the through hole 20 and the outlet passage 25 are separated by the piston valve 21. Here, the function of the piston valve 21 allows the fluid 10 to be delivered from the container 9 through the internal space 32, the through hole 20 and the outlet passage 25 to the discharge opening 24, but from the outlet passage 25 to the through hole. Is to prevent the backflow of the fluid 10 to 20.

  Using the piston valve 21 establishes a closed system, i.e., a system that does not flow back into the system once the fluid 10 exits the system. This effectively prevents pathogens and bacteria from entering the closed system. This prevents any invasion of pathogens, so there is no need to use materials that have the ability to interact with pathogens or trace active substances, so any suitable material can be used for components in a closed system. Brings the possibility of use. However, it may be advantageous to use materials that can interact with pathogens by stopping or slowing the growth of pathogens, or to use trace active substances.

  The outlet passage 25 is provided as a very thin and small capillary, which reduces the dead volume, ie the volume of fluid outside the closed system and in contact with the decontamination means.

  According to the embodiment of the present invention, an antibacterial coating material can be provided on a part of the inlet valve 26 and a part of the pump housing. The dressing can be applied directly to the plastic components and steel components of the pump.

  An inlet valve 26 including a ball 28 that cooperates with the valve seat 27 is formed in the valve portion 14. A spring 29 fixed to the piston 19 is supported on the protrusion 30 on the valve portion 14 and supports the pump operation. The space inside the hollow cylinder 6 between the piston 19 and the valve part 14 is indicated by reference numeral 32.

  The valve ball 28 can include materials that are capable of ultimately interacting with pathogenic bacteria even through trace active substances. Further, the inside of the inner hollow cylindrical portion 18 in the region of the valve seat 27 and the piston valve 21 may be coated with a material capable of finally interacting with a pathogen even through a trace acting active substance. The piston valve 21 may be made of any inert material such as plastic.

  Further, the spring means 29 may include a material capable of finally interacting with a pathogen even through a trace active substance. In principle, any suitable material may be used as long as the material is compatible with the formulation.

  A suitable material for the above device components has been shown to be stainless steel. In general, stainless steel contains relatively large amounts of alloying elements such as chromium, nickel, molybdenum, copper, tungsten, aluminum, tantalum, niobium and titanium, while the balance corresponding to the majority of the alloy is iron. is there.

  Stainless steel is known to be corrosion resistant. Corrosion resistance is due to the extremely thin and very strong chromium oxide layer on the steel surface. Chromium, like other heavy metals, can act as a microactive substance that can reduce microbial growth in very small amounts. For example, useful stainless steel materials include materials 1.4034 and 1.4401. In various embodiments of the present invention, effective pathogen killing can be achieved when a suitable steel, such as chromium stainless steel, is used as the microactive agent in the helical body 29 and the inlet valve 26. . Since the upper spring 23 does not come into contact with the fluid to be filled, the upper spring 23 may be formed of a stainless steel material.

  From the point of view of compatibility with stainless steel, nickel-free stainless steel or stainless steel with a very low nickel content is used, especially considering possible allergic reactions.

  Within the closed system, in particular for the inlet valve 26, ball 28, valve seat 27, inner part of the hollow cylindrical part 18, spring means 19 and for all parts of the fluid dispenser in contact with the fluid 10, It is possible to use any material capable of interacting with pathogens, such as silver, silver salts, other silver compounds, stainless steel and metal or salt forms or their nanomers as these compounds, or plastics , Should be noted.

  On the other hand, the materials and components used in the closed system may not contain any trace active substance.

  The metering pump of the present invention operates without air pressure compensation. That is, no pressure compensation occurs in the container 9 due to the inflow of air during operation. Therefore, invasion of pathogenic bacteria or bacteria into the container 9 or the closed system by air is prevented.

  The metering pump of the present invention operates as follows. When the user removes the cap 3 and pushes the operating plunger 2 so as to push it into the second pump body 5, a corresponding movement of the piston 19 against the force of the spring 29 occurs simultaneously. As a result, the ball 28 is pressed more strongly against the valve seat 27, and pressure is applied to the liquid 10 that has been sucked into the internal space 32 and the through hole 20 during the previous operation of the metering pump. This pressure causes the piston valve 21 of the outlet valve 22 to move against the force of the spring 23 to open the connection to the outlet passage 25 and allow a precisely measured amount of liquid 10 to pass through the discharge opening 24. Discharge. As soon as the piston 19 reaches its dead center position, the pressure in the interior space 32 and in the through hole 20 drops so much that the outlet valve 22 closes and the inlet valve 26 opens, so that the liquid 10 is sucked out of the container 9. Thereafter, the inlet valve 26 is closed again. Shortly thereafter, the user places the cap 3 on the plunger 2 again, thereby closing the discharge opening 24.

  The liquid remaining in the discharge opening 24, in the outlet passage 25 and in the through-hole 20, and in the internal space 32 and in the inlet valve 29 comes into contact with various places, where a micro-acting sterilizing substance is Contact fluid.

  The container 9 filled with sterile fluid may be formed of a flexible material such as a plastic material. In some cases, depending on the end use of the device, the container 9 may consist of a system with at least two bags including an outer portion and an inner bag as a reservoir for sterile fluid.

  In a preferred embodiment, the container 9 consists of an outer container and an inner container with fluid 10. The inner container is formed of a flexible material, and the inner flexible container is used to compensate for the pressure inside the flexible container as the fluid 10 is aspirated each time the metering pump is operated. Shrink. Therefore, pressure compensation in the flexible container is achieved without inflowing air into the inner flexible container. Preferably, the outer container is formed of a non-flexible material to allow the user of the fluid dispenser to properly hold the fluid dispenser and operate the metering pump. Furthermore, the outer container can protect the inner flexible container from breakage. During operation of the metering pump, at least one small opening is provided in the outer container to allow the inner flexible container to contract and to avoid negative pressure between the two containers.

  If the system described above is used, inflow of air into the container is prevented. Furthermore, with each operation of the metering pump, the inner flexible container contracts, i.e. its volume decreases. This provides constant contact of the fluid 10 with the metering pump inlet opening 15. Therefore, the fluid 10 can be discharged through the inlet opening 15 regardless of the direction of the fluid dispenser, that is, regardless of how the user holds the fluid dispenser. This allows the fluid dispenser to be operated at 360 ° use, ie upright, upside down, or any other location.

  Further, most of the components included in the container 9 including the operation plunger 2 and the pump body 4 other than the decontamination means 33 are made of plastic materials or the like because of the recognized advantages in terms of cost and manufacturing. You may form with a flexible material. For other reinforcing or load bearing components, such as springs 23 and 29, the plastic material must be strong enough to maintain the integrity of the spring over the useful life of the container 9. . Further, in the case of wearable components such as valve ball 28, inlet valve 26 and outlet valve 22, the plastic material must be a wear resistant plastic material. Further, as described above, the contamination removing means 33 may be formed of a plastic material coated with a trace active substance.

  One embodiment of the present invention provides a fluid dispenser that includes a cap 3 to cover and seal the discharge opening 23. The cap 3 is provided with a pin 3a and a hole 3b. The pin 3 a fits into the ejection opening 24 located in the head 16. The hole 3b functions as a ventilation means. By sending air through this hole 3b, excess fluid remaining after use can be evaporated, thus providing further protection against contamination.

  The fluid dispenser according to the present invention is perfect for dispensing trace amounts of any kind of liquid, preferably a liquid pharmaceutical composition. In a preferred embodiment of the present invention, the fluid dispenser may be used to dispense liquid pharmaceutical compositions such as ophthalmicum or nasalium. Further applications are fluids used as medical devices or cosmetics. The fluid dispenser according to the present invention can be utilized in any size depending on the end use.

  Although the present invention has been described in connection with one or more embodiments, the specific mechanisms and techniques that have been described merely serve to illustrate the principles of the invention and have been described. Numerous changes may be made in the method and apparatus without departing from the spirit and scope of the invention as defined by the appended claims.

  Microbiological test: The microbiological safety of the fluid dispenser was confirmed by a medium filling test and a dye test. These tests focused on evaluating the tightness of the system and the protection of the fluid dispenser opening. The fluid dispenser opening was protected from microbiological growth by the design of the area of the opening. It is believed that not only the length of the capillary but also the shape and small diameter of the tip region make it more difficult for microorganisms to enter the fluid dispenser. The antibacterial effect is achieved in particular by the position of the outlet valve designed to be less susceptible to contamination by microorganisms and the configuration of the dead volume at the outlet. The covering cap of the fluid dispenser may have a hole where moisture evaporates. In addition, a silver helix was placed immediately after the fluid dispenser opening to reduce any residual risk. Metallic silver exerted a trace effect.

  Use test: A simulated daily use microbial challenge study was conducted to simulate the use of the fluid dispenser during use. The objective was to determine whether microorganisms were introduced into the fluid dispenser after harsh use. Microorganisms typically encountered by consumers were examined by dispensing droplets from a fluid dispenser. The droplet was also placed at the tip of the fluid dispenser. At the end of the test period, the sterility of the reservoir was examined. The results of the usage test showed that no test microorganisms entered the fluid dispenser reservoir during the daily use simulation of the dispenser.

  The fluid dispenser of the present invention is suitable for dispensing small amounts of liquids in various fields such as pharmaceuticals, cosmetics and medical devices.

2 shows a longitudinal section of one embodiment of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Pump main body 2 Operation plunger 3 Cap 3a Pin 3b Hole 6 Hollow cylinder 7 Tubular flange 9 Container 10 Fluid 11 Sealing part 12 Transition part 14 Cylindrical valve part 15 Inlet opening part 16 Head 17 Outer hollow cylindrical part 18 Inner hollow Cylindrical portion 19 Piston 20 Through hole 21 Piston valve 22 Outlet valve 23 Spring 24 Discharge opening 25 Outlet passage 26 Inlet valve 27 Valve seat 28 Ball 29 Spring 30 Protruding portion 32 Internal space 33 Contamination removing means

Claims (21)

An outlet opening for a fluid contained in a supply container made of flexible material and having at least one microactive substance for dispensing the liquid and in contact with the fluid therein A through passage connecting the opening,
A metering pump that operates without air pressure compensation so that no pressure compensation occurs in the container through the inflow of air during operation, the pump comprising spring means in contact with the fluid, the inlet opening A metering pump that includes an inlet valve for closing the outlet and an outlet valve, and an outlet passage that is part of the through passage leading from the outlet valve to the discharge opening,
A fluid dispenser for aseptic fluid comprising:
Here, the ability to interact with pathogens through trace agents selected from the group consisting of silver, silver salts, other silver compounds, alloys and metals or salts or these nanomers as these compounds. A fluid dispenser for aseptic fluid, wherein a decontamination means including a material having the material is provided at an upper portion of the outlet passage. 2. A fluid dispenser according to claim 1, wherein the inlet valve and / or the spring means comprises a material capable of interacting with pathogenic bacteria. 3. The material according to claim 2, wherein the material is selected from the group consisting of silver, silver salts, other silver compounds, stainless steel, and metals or salts, or these nanomers as these compounds. Fluid dispenser. The stainless steel contains at least one element selected from the group consisting of chromium, nickel, molybdenum, copper, tungsten, aluminum, titanium, niobium and tantalum, and the balance is iron as a main component. Fluid dispenser. The fluid dispenser according to claim 1, wherein the through passage is always filled with the fluid at least in the region of the inlet valve. The fluid dispenser of claim 1, wherein the trace active substance is provided inside a cap that can be fitted over the fluid dispenser to cover the discharge opening. The fluid dispenser according to claim 6, wherein the cap is provided with a pin and a hole. The fluid dispenser according to claim 7, wherein the pin is fitted in the discharge opening located in the head. The fluid dispenser of claim 2, wherein the inlet valve further includes a valve seat that cooperates with a closure member, wherein the valve seat is provided with the microactive substance. The fluid dispenser of claim 2, wherein the outlet valve further includes a valve seat that cooperates with a closure member. The fluid dispenser according to claim 2, wherein the inlet valve is a ball valve, and a valve housing that cooperates with a closing member of the inlet valve is provided, and the material is provided in the valve housing. The fluid dispenser according to claim 1, wherein the outlet valve is a piston valve, and a valve housing that cooperates with a closing member of the outlet valve is provided. The fluid dispenser according to claim 1, wherein the decontamination means is made of a circular material. The fluid dispenser according to claim 13, wherein the decontamination means is an annular body. 14. A fluid dispenser according to claim 13, wherein the decontamination means is a spiral. The fluid dispenser according to claim 1, wherein the decontamination means is a covering material. 14. A fluid dispenser according to claim 13, wherein the material is a corundum in which the trace active compound is embedded. The fluid dispenser of claim 13, wherein the material is silver. The method of using a fluid dispenser according to claim 1 for dispensing a trace amount of liquid in the fields of pharmaceuticals, cosmetics and medical devices. 20. A method according to claim 19, wherein the liquid is applied topically. The method according to claim 20, wherein the liquid is an ophthalmic drug or a nasal drug.

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