RU2410302C2 - One-stroke valve block - Google Patents

Abstract

FIELD: machine building.

SUBSTANCE: one-stroke valve block of continuous packing with system of supply for distribution of fluid substance consists of reservoir for storage of fluid substance with port and of valve block with cover. Also, the valve block connected to the port of the reservoir includes an internal core with an inlet orifice for reception of fluid substance into a pass channel and at least one outlet orifice from the pass channel, and a hollow elastic membrane with two ends, the first of which has thickness bigger, than the second end. Additionally, the hollow elastic membrane is located over external surface of the internal core; after supply of pressure fluid substance passes through at least one orifice and expands the above said membrane outward from external surface above the internal core. Notably, the cover consists of the flexible membrane and has the outlet orifice for distribution of fluid substance from the valve block at fluid substance pressure build-up. Upon termination of pressure build-up in fluid substance, the first end of the hollow elastic membrane comes back firmly adjoining external surface of the internal core, before the rest of the hollow elastic membrane returns onto external surface above the internal core. The reservoir is filled with medicine for eye or nasal cavity cure containing hyaluronic acid or its derivatives, but not containing preservatives.

EFFECT: valve block with inlet orifice preventing back flow of fluid substance into source upon ejection of separate doses.

54 cl, 11 dwg

Description

The present invention relates to a distribution and supply system comprising a one-way continuous seal valve unit for dispensing a sterile fluid substance, which may or may not contain preservatives, while preventing the possibility of a return of fluid substance to the source. In the distribution and supply system, there is, for example, a valve block with an elastic or elastomeric element, which is displaced under pressure to pass the fluid substance into the adjustable outlet, while preventing the back flow of the fluid substance into the source after the distribution of individual portions or doses of the fluid substance.

BACKGROUND OF THE INVENTION

Previously, in order to prevent contamination of the fluid substance, preservatives were added to the reservoir from which it was planned to be distributed. The use of preservatives can be unsafe for people for whom the substance is intended, and in many cases does not allow to achieve the maximum effectiveness of the use of a fluid substance, in particular for pharmaceutical purposes, for example, in ophthalmic solutions, intranasal preparations or cosmetics or skin care products. The recipe for this group of prescription or non-prescription drugs is often formulated with preservatives in multi-dose formats. The fluid substance may also be any food, drink, food supplement, or cosmetic.

Another factor to consider is the ability of the valve block to pass a predetermined amount of fluid substance into the outlet without any harm to the user, for example, by direct instillation of an ophthalmic solution.

In the past, flexible membranes were used to control the flow of fluid substance at the outlet of the valve block, while simultaneously preventing the return of the fluid substance to its source. However, for valves such as those described in US Pat. No. 3,4243, the full text of which is referenced herein, the use of o-rings in combination with a uniformly dense flexible membrane to enhance sealing is described. Other valve blocks also used cylindrical elements, which were necessary, for example, to move a pre-stretched flexible membrane over a straight sleeve during assembly, which prevented automatic high-speed assembly. Thus, in the past there was no effective design of valve blocks that could be manufactured, for example, on high-speed automated equipment with a reduction in production costs due to a decrease in the number of parts.

SUMMARY OF THE INVENTION

In accordance with an example embodiment of the present invention, the distribution and supply system directs the fluid substance from a closed source (reservoir), for example a flexible reservoir, while preventing the return of oxygen or other pollutants from the environment through the valve block to the source with the fluid substance after the distribution of its portion is completed.

The flexible reservoir may be, for example, a bellows type reservoir, a flexible tube, an inner pouch, or a corresponding reservoir of another type, designed to distribute practically all of its contents. According to an embodiment of the present invention, the distribution and delivery system has a normally closed adjustable outlet for distributing an adjustable amount of fluid substance through the valve block. The tank is hermetically connected to the valve block, so its contents are not mixed with any contaminants when distributing the fluid substance.

The process of distributing a fluid substance is affected by applying pressure directly to the tank or by means of a pump, so its contents are directed and passed through the valve block. This content can be used for pharmaceutical purposes, for example, in ophthalmic or nasal solutions and / or gels, for which no contaminants are allowed during distribution. In accordance with an example embodiment of the present invention, a certain number of doses of liquid can be obtained without resorting to the use of preservatives for the initial fluid substance. The tank is located in a protective housing, which eliminates the accidental supply of pressure.

The valve block kit includes, for example, an axially elongated structure that opens into a dispenser or reservoir with a fluid substance. The valve block may consist of an axially elongated inner core opening into the reservoir and a rigid plastic component. The inner part of the core may have a passageway for the flow of fluid substance from the reservoir. At least one opening from the passage channel may be used, providing a flow of substance from the inner core. The inner core may be in the form of a truncated or nearly complete cone.

The axially elongated flexible membrane tightly covers the inner core and through it closes the outlet tip (inlet end) of the hole. The flexible membrane moves away from the inner core when pressure is applied to the fluid substance, which passes through the hole, moving to the output end of the flexible membrane. The flexible membrane is designed in such a way that, for example, its part closest to the valve outlet has a denser structure. In other words, a flexible membrane has an uneven thickness along its entire length. This design allows the valve to first shut off the area at the thicker end of the membrane. Alternatively, even with the same thickness of the membrane, its elasticity can vary so that the part that is closest to the valve hole is less elastic, as a result of which this part will close first.

In the exemplary embodiments, the flexible membrane and, as described above, the inner core are in the form of a truncated or full cone, which ensures quick assembly and natural placement of the flexible membrane above the inner core.

The valve cover, located on the side on the outside of the flexible membrane, ends near an adjustable outlet. The fluid substance under pressure moves between the outwardly extending outwardly flexible membrane and the outer surface of the inner tip, and then enters the outlet. The outlet is intended for controlled quantities of the fluid substance to be distributed. To protect the valve block during storage, the outer part of the valve block closes the top cover. The valve block can be attached to the tank using a sleeve, which ensures tight installation and prevents any contaminants from entering the tank. The coupling and the neck of the tank are equipped with locking devices that allow the coupling to move during installation, but subsequently prevent the possibility of unwinding and disassembling it, which can lead to uncorking and contamination of the system.

Various innovations characterizing the invention are shown with specific details in the claims that are attached and form part of this disclosure. For a better understanding of the essence of this invention, the principles of its operation, advantages and specific goals achieved when using it, you should take into account the accompanying drawings and visual materials, which describe and illustrate a preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is an axially-elongated image of a distribution and supply system in accordance with an embodiment of the present invention.

Fig. 2A is an exploded view of a distribution and supply system similar to that shown in Fig. 1 in accordance with an embodiment of the present invention.

FIG. 2B is an exploded view of a distribution and delivery system similar to that shown in FIG. 1 in accordance with an embodiment of the present invention, which includes a pump for distributing a fluid substance.

Figure 3 is an exploded view of a soft cover and its adjustable outlet in accordance with an embodiment of the present invention, where the outlet is in the form of a longitudinal slot.

4A is an enlarged axially elongated partial view of a one-way continuous seal valve block with a flat top soft cover in accordance with an embodiment of the present invention.

FIG. 4B is an enlarged axially-elongated partial view of a one-way continuous seal valve block with a rounded soft cover in accordance with an embodiment of the present invention, where the one-way continuous seal valve block is in its initial position.

4C is an enlarged axially elongated partial view of a one-way continuous seal valve block with a rounded soft cover in accordance with an embodiment of the present invention, where the one-way continuous seal valve block is in a distribution position.

Fig. 4D is an enlarged axially elongated partial view of a one-way continuous seal valve block, where the hole in the soft cover comprises a portion of a flexible membrane and an inner core of the valve block in accordance with an embodiment of the present invention.

Fig. 5 is an enlarged axially elongated partial view of a one-way continuous seal valve assembly shown in Figs. 4B and 4C in accordance with an embodiment of the present invention.

6A is an axially-elongated partial view of a one-way continuous seal valve block with one hole and an outlet in accordance with an embodiment of the present invention.

Fig. 6B is an enlarged axially elongated partial view of a one-way continuous seal valve assembly with one opening and an outlet in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIGS. 1, 2A and 2B, the distribution and supply system 1, in accordance with an embodiment of the present invention, is formed from a bellows type reservoir or a source 2 located inside the housing 6. In the housing 6, a fluid reservoir 2 is fixed, preferably sterile or non-sterile, valve block 3 (shown in FIGS. 2A, 2B and 4A-D) for supplying fluid from the tank 2 to the outlet when applying pressure to the tank 2 or actuator 2a connected to the tank 2. The top cover 15 closes the valves ny unit 3 to prevent contamination by impurities that during storage can enter the valve unit 3. The housing 6 has a surface 6a for mounting the unit. The coupling 8 connects the valve block 3 to the reservoir 2, providing a tight connection, which prevents the possibility of external impurities entering the reservoir 2.

Referring again to FIGS. 1, 2A and 2B, it can be seen that the bellows reservoir 2 is large enough to distribute many doses from the reservoir and is compressed under pressure thereon. You can use other appropriate containers, such as a flexible pipe or inner bag, which allow the possibility of the distribution of many doses of fluid substance. The valve block 3 and the coupling 8 prevent air or other impurities from entering the tank after the distribution procedure.

Referring again to FIGS. 1, 2A and 2B, it can be seen that the bellows reservoir or source 2 is laterally closed, for example, by an axially elongated housing 6 to protect against accidental application of pressure to the reservoir. Through a slot 6b axially elongated in the housing 6, the user can access the reservoir drive 2a when the fluid is released under pressure. The housing 6 has surfaces 6a for attachment during the distribution of fluid substance.

Turning to FIGS. 2A and 2B, it can be seen that the valve block 3 has a cover 14 that surrounds the flexible membrane 13. The valve block 3 consists of an inner core 10, an axially elongated through passage 11, holes 12, a flexible membrane 13, and a cover a valve 14 with a flange 14a and a soft cover 7 with an adjustable outlet 7a (more details are described below with reference to FIGS. 4A-D). Since the flexible membrane 13 is hollow, which allows the inner core 10 to be placed in it, it is clear that after installation on the device, this hollow part will be occupied by the core 10, so there will be no gap when the valve block is stationary.

The end of the valve cover 14 connected to the tank 2 has an elongated flange 14a located outwardly radially adjacent to the flange at the edge of the flexible membrane and acting on the valve block seal at the outlet of the tank 2. A tight fit of the opening or neck of the tank 2 to the flange 14a is ensured , for example, by means of a screw thread that is interfaced with the sleeve 8. Alternatively (or as an additional option), the sleeve 8 and the opening or neck of the tank 2 perform the functions of blockers that allow ix clutch 8 during assembly but subsequently prevent the possibility of its unwinding and disassembly, which can lead to raskuporivaniyu system. This prevents the possibility of contamination during operation by the user, and also eliminates the possibility of overfilling the system.

Referring specifically to FIG. 2B, it can be seen that in a structure suitable for supplying fluid substance by a pump, the pump unit 16 is connected to the valve unit 3a, the reservoir 2, and the bulb 6b. The sleeve 8 covers the connection between the pump unit 16 and the valve unit 3a. The pump unit 16 is connected to the flask 6 using screw connections. A tight fit of the hole or neck 6 to the pump unit 16 is provided, for example, by means of a screw thread that is interfaced with the pump unit 16, sealing the flange 2c of the tank 2 between the flask 6 and the pump unit 16. As an alternative (or as an additional option), the coupling 8 and the opening or neck of the tank 2 perform the function of blockers, which allow the displacement of the pump unit 16 during installation, but subsequently prevent the possibility of unwinding and disassembly, which can lead to uncorking of the system. This prevents the possibility of contamination during operation by the user, and also eliminates the possibility of overfilling the system.

Thus, the pump unit 16 is connected to the valve block 3a, which has an actuator 17, an inner core 10, axially elongated through passage channels 11, openings 12, a flexible membrane 13, a valve cover 14 with a flange 14a and a soft cover 7 with an adjustable outlet 7a (more detailed information is given below with descriptions of FIGS. 4A-D). Alternatively, the actuator 17 may be connected to or included with a spray gun. During operation, the actuator 17 is used to transmit force through the control valve of the pump unit 16 to move the fluid substance from the reservoir 2, thereby providing the force required to distribute the fluid substance. For example, standard pumps can be used in this way.

Moreover, the reservoir 2 may be located inside the flask 6, whose open end is sealed with a plug 2c. The plug 2c is necessary to protect the tank 2 from damage, rupture or careless use of force on the tank 2.

Turning to FIG. 3, it is seen that the adjustable outlet 7a is presented in the form of a longitudinal slot, which allows a substantially tight distribution of fluid substance to be made. The longitudinal slot causes self-closing of the adjustable outlet 7a after the release of pressure.

The shape of the adjustable outlet 7a can be changed to spray or flow out a fluid substance. In addition, by changing the size of the adjustable outlet 7a, it is possible to distribute the fluid substance in the form of drops, for example, when it comes to ophthalmic solution. If necessary, the shape of the adjustable outlet 7a can be changed to distribute a larger amount of fluid substance, for example, an ophthalmic or nasal solution and / or gel.

Referring to FIGS. 4A-D, it can be seen that the valve block 3 has an inner core 10, an axially elongated through passage 11, openings 12, a flexible membrane 13, a valve cover 14 with a flange 14a, and a soft cover 7 with an adjustable outlet 7a. The top cover 15 covers the valve block 3 when not in use to prevent outside contamination.

In the valve block 3, the axially elongated inner core 10 fits snugly against the opening of the reservoir 2, so the fluid flow from the reservoir passes into an elongated through passage channel 11 in the inner core. The passage channel 11 expands to extend most of the axial length of the inner core. At about half the length of the passage channel 11, the inner core has a pair of holes 12 extending perpendicular to the axis of the passage channel from its surface to the outer surface of the inner core 10. The inner core 10 is made of, for example, hard plastic and ends inside the outlet end of the valve block. Moreover, in the examples of implementation, it is shown that during the installation and filling of the block, air is absent in the passage channel 11 and holes 12. It should be noted that additional holes 12 may be located in the inner core 10.

Moreover, the embodiments show that the inner core 10 and the flexible membrane 13 are designed so that their parameters are identical, for example, they have similar tolerances, which allows the use of an airtight seal between the flexible membrane 13 and the inner core 10. In further embodiments of the invention, the molding method for the flexible membrane 13 and the inner core 10, as well as the other components described above as being closely adjacent to each other, is asymmetric molding process, in which a surface is created with virtually no defects or seams at the contact points during compaction. Accordingly, in an embodiment of the invention, very close tolerance values between the parts, for example, the inner core 10 and the flexible membrane 13 and others, are used to ensure optimal sealing and operation of the valve block.

A flexible membrane 13, for example an elastomeric element, fits snugly over the outer surface of the inner core and extends from the opening in the reservoir 2 to the opposite end of the inner core 10. As can be seen in FIGS. 4A-D, the thickness of the membrane varies along its axial length. In the area of the output end of the inner core, for example, the axially elongated constant continuous end part is much thicker than in the remaining flexible part of the membrane 13. That is, the strip does not break along the axial length of the axially elongated cuts. The denser end portion closes the valve after the distributed fluid enters first in that portion which is closest to the opening 7a, as described below, whereby the return of fluid is excluded. This process is influenced by a significant wall thickness, which provides a large degree of tension. As a result, the tension of the flexible membrane 13 will be uneven.

In the following example, in other embodiments, the thickness of the membrane may vary along its axial length, and the region surrounding the output tip of the inner core contains, for example, an axially elongated continuous continuous annular strip that is significantly thicker than in the remaining flexible portion of the membrane 13. Moreover, in some examples, the strip is not torn along the axial length by axially elongated notches. Alternatively, the elasticity or hardness tester of the end portion of the flexible membrane closest to the valve opening may vary, for example, it may be reduced so that the portion closest to the valve opening closes first after the pressure has been relieved.

In the following example, the flexible membrane 13 and the inner core 10 are in the form of a truncated or almost complete cone in the end parts closest to the adjustable outlet 7a, so that the inner core 10 enters the flexible membrane 13 during installation using high-speed automated production equipment.

At the end of the flexible membrane 13 adjacent to the opening of the tank 2, there is an elongated outward flange that fits snugly against the flange on the inner core located at the opening of the tank.

An axially elongated valve cover 14 surrounds the flexible membrane 13 and, as shown in the initial position in FIG. 2a, is radially outward from the outer surface of the flexible membrane. The end of the valve cover 14, connected to the tank 2, has an elongated flange 14a located outwardly radially adjacent to the flange at the edge of the flexible membrane and acting on the valve block seal at the outlet of the tank 2.

The valve cover 14 consists, for example, of an inner layer of elastomeric material elongated axially from its flange 14a to and above the output end of the valve block 3. The elastomeric material forms a soft cover 7 above the outlet end of the valve cover 14, which is extremely useful when the valve block is used to distribute the solution for the eyes. Such a soft cover 7 protects, for example, from any possible damage to the fragile outer shell of the eye or the tissue around it. The soft cover 7 has an adjustable outlet 7a for distributing fluid substance. The outlet is closed in the initial position of the one-way valve block of the continuous seal and is open during distribution.

Referring again to FIGS. 4A-D and FIG. 5, various examples of the embodiment of the valve block 3 can be seen, in which embodiments of the soft cover 7 are shown, as described below.

Referring specifically to FIG. 4A, the valve block with a flat top soft cover 7 can be seen. The soft cover 7 has a flattened upper part, which allows limiting the amount of fluid entering the adjustable outlet 7a, since, due to the design with a flattened top, the size of the outlet 7a decreases. The soft cover 7 has an adjustable outlet 7a, the size of which can be changed to spray or leak fluid substance. Moreover, the adjustable outlet 7a may be a longitudinal slot, as shown in FIG. Alternatively, by changing the size of the adjustable outlet 7a, it is possible to distribute the fluid substance in the form of drops, for example, if we are talking about a solution for the eyes or another solution distributed in the form of drops. If necessary, the shape of the adjustable outlet 7a can be changed to distribute more fluid substance, such as an ophthalmic or nasal solution and / or gel, increasing its diameter.

Referring to FIGS. 4B-C, a valve block with a rounded top soft cover 7 can be seen. The soft cover 7 has a rounded top for distributing fluid substance to the outer shell of the eye or the tissue around it, or to other sensitive organs. Since the round tip does not have sharp edges, this eliminates or minimizes the possibility of damage to the eye or sensitive tissues from accidental contact when using a fluid substance. The soft cover 7 has an adjustable outlet 7a, the size of which can be changed to spray or leak fluid substance. Moreover, the adjustable outlet 7a may be a longitudinal slot, as shown in FIG. Alternatively, by changing the size of the adjustable outlet 7a, it is possible to distribute the fluid substance in the form of drops, for example, if we are talking about a solution for the eyes or another solution distributed in the form of drops. If necessary, the shape of the adjustable outlet 7a can be changed to distribute more fluid substance, such as an ophthalmic or nasal solution and / or gel, increasing its diameter.

Turning specifically to FIG. 4D, one can see the valve block with a flat cover 7, which has an enlarged adjustable outlet 7a. The size of the adjustable outlet 7a allows the inner core 10 and the flexible membrane 13 to be placed in it and can be used to distribute viscous fluid substances, for example lotions, creams and emollients, as well as any fluid substances. The size of the adjustable outlet 7a allows you to distribute the fluid substance without having to move it through two holes, namely through the hole near the end of the flexible elastomer 13 and through the adjustable outlet 7a, since they are now filled.

Referring to FIG. 5, it is possible to more closely examine the gap formed between the inner core 10 and the flexible membrane 13 by means of pressurized fluid exiting the openings 12. You can also see the adjustable outlet 7a in the soft cover 7, which can be, for example, a uniform round hole in the material of the soft cover 7 or have the appropriate size, as described in the previous paragraphs.

Referring to FIGS. 6A-B in another embodiment, it can be seen that the fluid substance passes through a separate hole 12 in the inner core 10 and stretches the flexible membrane 13, forming a swirl around the outer part of the inner core 10 and exiting through the hole 12a, as shown on figa and 6B. As a result, the distribution of fluid substance requires a lower valve opening pressure, which is extremely useful when used with fluid substances (but not limited to them) with a higher viscosity, such as viscoelastic solutions and / or viscoelastic gels. It should be noted that additional holes 12 may be located in the inner core 10.

In the example of use, if necessary, the distribution of fluid substance, the top cover 15 is removed, and the pressure is transmitted through the actuator 2a of the tank 2, so a certain amount of fluid substance flows from the tank into the passage channel 11 in the inner core 10. The substance passes through the holes 12, stretching the flexible membrane 13 across radius to the outside, and directly enters the outlet head of the flexible membrane, from where it exits from the flexible membrane radially inward to an adjustable outlet 7a in the cap, and then distributes It is.

During the distribution of the fluid substance and its exit into the outlet head of the flexible membrane, it flows radially inward into the adjustable inlet 7a, which then opens, releasing the substance from the valve block. After the distribution of the fluid substance is completed and the supply of pressure to the source is stopped, the adjustable outlet 7a closes, blocking the return of fluid to the valve block. The top cover 15 covers the valve block 3 when not in use to prevent outside contamination.

In another example, as shown in FIGS. 6A and 6B, a fluid substance passes through a single hole 12 in the inner core 10 and stretches the flexible membrane 13, forming a swirl around the outer part of the inner core 10 and exiting through the hole 12a, as shown in FIG. 6A and 6B. As a result, the distribution of fluid substance requires a lower valve opening pressure, which is extremely useful when used with fluid substances (but not limited to them) with a higher viscosity, such as viscoelastic solutions and / or viscoelastic gels.

After depressurizing the reservoir actuator 2a, the distribution process stops and the flexible membrane 13 returns inward to the outer surface of the inner core 10. The inward movement of the flexible membrane begins at its outlet end due to its increased thickness and allows gradual contact with the outer surface of the inner core, returning any fluid substance through the openings to the tank, so contaminants cannot get into it. The distribution of individual batches of fluid substance can be continued almost until the tank is completely empty. As a result of the construction and operation of the valve block, in accordance with an embodiment of the present invention, uniform pressure is provided on the valve components by means of a pressurized fluid substance.

In another embodiment, the spray pump, an example of which is shown in figv, the actuator 17 is used to transmit force to the pump unit 16 while reducing pressure on it. This, in turn, causes the compression of the tank 2, thereby providing the force necessary to open the valve block, and in some examples described above, of the adjustable outlet 7a, for distributing the fluid substance.

Elastomeric materials suitable for forming a soft cover 7, a flexible membrane 13, and a valve cover 14 in embodiments of the present invention include thermoplastic elastomers such as Dynaflex manufactured by GLS Corp., C-Flex manufactured by CPT Inc. or Santoprene, which is manufactured by Advanced Elastomer Systems, Inc. Elastomers, as well as materials containing any other components of the device, can integrate, impregnate or, alternatively, place antimicrobial ingredients inside them, for example silver ions contained inside a ceramic crystal holder and similar to those supplied by AgION, or ionic silver release components manufactured by Westlake Plastic Technologies and used in the manufacture of antimicrobial plastics. Moreover, it is possible to use other antimicrobial materials suitable for mixing with plastic or coating it. In addition, the soft cover 7, the flexible membrane 13, or both of them can, for example, have a positive charge to reject the remaining fluid substance, as well as have a Teflon coating, increased surface tension, possess moisture repellent properties, or combine any of the listed properties to reject fluid substance .

In other embodiments, including those described above, the value of the hardness tester of elastomeric materials can vary according to the viscosity of the fluid substance. For example, blocks containing substances with relatively high viscosity indices will use softer elastomeric materials, i.e. with lower hardness indicators to reduce the force required to distribute the substance, while for flowing substances with lower viscosity, harder elastomeric materials, i.e. with higher hardness gages to ensure reliable compaction. Similarly, for fluid substances containing lubricants, harder elastomeric materials will also be used, i.e. with higher hardness indicators, to ensure reliable compaction.

As described above, the components of the dispensing and feeding device, including the valve block, can be manufactured with a tight tolerance to ensure air impermeability, as well as accurate assembly, which ensures optimal sealing and operation of the device.

Ophthalmic or otorhinolaryngological preparations, as described below, can be distributed, where it is important, to ensure their safety from contamination by substances from the surrounding atmosphere. The flow characteristics of the substance to be distributed determine the type and size of the valve block.

As already mentioned, the fluid substance can be a pharmaceutical substance that does not contain preservatives, for example, ophthalmic or otorhinolaryngological preparations, examples of which are given below, for which it is necessary to protect against ingress of impurities from the surrounding atmosphere and for which the use of preservatives is not provided during storage in the tank 2. Ophthalmic or otorhinolaryngological preparations indicated below can be stored in tanks and distributed from them with The one-way valve block of the continuous seal and the feed system described in this invention.

The following are examples describing the categories of medications that can be stored in tanks and distributed from them using a one-way continuous seal valve block and the delivery system described in this invention. The storage and distribution of these substances without the use of preservatives can also be carried out using, for example, multi-dose, highly impermeable, preservative-free systems as described in US Pat. Nos. No. 34343; 5092855; 5,305,783; 5,279,447; 5,305,786; and 5353961, the full text of which is incorporated herein by reference.

EXAMPLES

Example 1

In an exemplary embodiment, preservative-free ophthalmic or otorhinolaryngological preparations can be stored in the reservoirs and dispensed from them using the one-way continuous seal valve block and delivery system described in this invention. For example, eye drops, in particular those that are used in the treatment of chronic diseases, including dry keratitis, glaucoma, various types of allergies, as well as non-steroidal anti-inflammatory drugs and drops intended for emergency care, for example, during organ surgery of view, can be stored in the tanks and distributed from them using a one-way valve block continuous sealing and supply system described in this invention. In a further example, such eye drops used to treat eye fatigue caused by long hours at the computer, watching TV or long periods of wakefulness can be stored in tanks and dispensed from them using the one-way valve block continuous sealing and delivery system described in this invention.

Preparations used to treat dry keratitis may include, but are not limited to, cellulose derivatives, hyaluronic acid of various molecular weights, including high molecular weight directly or in combination with a low molecular weight component, polyethylene glycol 400 0.4%, propylene glycol 0, 3%, glycerol, dextran, ether polysorbate 80 and mineral oils. Examples include glaucoma medications consisting of 0.25% / 0.50% timolol, 0.1% brimonidine tartrate, 0.03% bimatoprost and 0.004% grass simple. Antiallergic drugs include substances consisting of 0.1% olopatadine hydrochloride and 1% prednisone acetate. Examples of non-steroidal anti-inflammatory drugs include preparations containing 0.5% ketorolac and 0.1% diclofenac.

Further, in selected embodiments for use in treating diseases of the organs of vision, a composition containing hyaluronic acid and emollients, together with appropriate excipients, is stored in the reservoirs and distributed from them using the one-way valve block of the continuous seal and the delivery system described in this invention. Examples and methods of manufacturing such compositions are given below.

In the present compositions, hyaluronic acid and / or its derivatives are used, which may be in the composition of its sodium, potassium, calcium or other salts with a concentration which in certain examples may vary from 0.05 to about 3.0% (in volumetric proportions) and have a molecular weight ranging from 300 thousand to about 7 million daltons in the native form and up to about 25 million daltons in the form with a transverse intermolecular bond.

In most cases, the use of proportions from 10 million to about 15 million, or from 10 million to about 25 million daltons of hyaluronic acid (high molecular weight hyaluronic acid) provides significant advantages when performing surgical operations on the organs of vision. Since patients undergo surgical intervention usually using some kind of sedative, high molecular weight hyaluronic acid can be used without fogging and the presence of a foreign body or eye irritation, which provides additional benefits. For example, the need for repeated irrigation of the eye during surgery is significantly reduced, since hyaluronic acid with a high molecular weight acts as a molecular sponge, absorbing and releasing a greater amount of irritating substances and water. In addition, the structure with a transverse intermolecular bond, presented in high molecular weight hyaluronic acid, allows the use of its lower concentration. In addition, the use of such a composition can be useful for coating the cornea during laser ablation, which is used in refractive surgery on the organs of vision. Since fogging and the sensation of the presence of a foreign body during such refractive operations using a laser are not a problem, the use of higher molecular weight hyaluronic acid will be effective. In addition, the structure with a transverse intermolecular bond, presented in high molecular weight hyaluronic acid, allows the use of its lower concentration.

In selected embodiments, from 1.4 to about 2.0, or from 1.5 to about 2.0 million daltons of hyaluronic acid provides significant advantages in formulations for treating dry keratitis and other non-surgical uses. For example, the possibility of side effects such as fogging and a sensation of the presence of a foreign body, as well as irritation of the membrane is minimized; this increases the effective retention time. As a result, the need for repeated use of the drug for the eye is reduced. In addition, the use of hyaluronic acid with the above molecular weights contributes to an improved and longer-term supply of sedative (reducing irritation) substances and excellent hydration of the corneal surface while maintaining the important elastic-viscous properties of eye drops. Thus, the elasticity and viscosity of the composition are preserved before, during and after the constant blinking process, which contributes to the formation of the coating and its reappearance on the ocular membrane and the inner surface of the eyelid.

In further embodiments, hyaluronic acid and / or its derivatives in combination with glycerin and / or any other irritation-reducing agents plays the role of an improved mucoadhesive substance, providing increased retention time and better coverage.

In other embodiments, it is possible to use visco-adaptive formulations for administering drugs in combination with a delivery pump or device that does not use preservatives in the ocular tissue in order to increase bioavailability and retention time. For example, the retention time of antibiotics in the eye tissues can be increased from minutes to hours. Among the drugs that can be administered in this way are drugs for the treatment of glaucoma and allergies, steroid drugs, antibiotics, non-steroidal anti-inflammatory drugs, inflammatory, anti-inflammatory, antifungal and other drugs that are injected locally into the eye tissue.

Such a visco-adaptive composition can be used to treat dry keratitis, which can be caused by harmful environmental conditions, surgery, fatigue from long work at the computer, air travel, high fever, iatrogenic dry keratitis, dry eye syndrome, trauma, drug use and disease.

The embodiments of the present invention provide several unexpected advantages, among which, for example, excellent coverage, improved mucoadhesive surface tension on the ocular surface, increased retention time, convenience for the patient, excellent hydration, clear visibility of surgical sites for surgeons, excellent and more symmetrical ophthalmic coating shell during refractive operations using a laser for the possibility of selective ablation of eye irregularities, as well as multi-dose, multi-purpose distribution drug definition.

For example, embodiments of the invention provide excellent coverage of the ocular membrane and conjunctiva with an increased in vivo retention time caused, at least in part, by a new combination of hyaluronic acid with a specific range of percentages and / or its derivatives with other anti-irritants, including but not limited to this, glycerin.

Moreover, the convenience for the patient is ensured by the elastic properties of hyaluronic acid and / or its derivative components, which is achieved by the new sizes and concentrations of acid used in the embodiments.

In addition, the excellent wettability of hyaluronic acid and / or its derivatives, achieved through the new percentages and concentrations of hyaluronic acid that are used in the embodiments, allows the acid to play the role of a molecular sponge that absorbs and releases anti-irritants and water when the patient blinks. In addition, the design provides greater clarity of vision of the patient due to the lower concentration of the used components of hyaluronic acid. Another unexpected advantage is the clear visibility of surgical sites for surgeons when using the formulations as a visco-adaptive liquid eye shield (eye drops) on the eye shell and a softer coating of the eye shell during laser refractive surgery.

Moreover, a dispensing system without the use of preservatives was developed, in which many doses of eye drops can be contained and distributed while protecting the composition from contamination and / or spoilage, which eliminates the need for additional costs associated with the use of disposable dispensing devices.

Such visco-adaptive eye drops are therefore very well suited for the treatment of dry keratitis, which can be caused by harmful environmental conditions, surgery, fatigue from long work at the computer, air travel, high fever, iatrogenic dry keratitis, dry eye syndrome, trauma, drug use, disease, surgical and postoperative use.

In certain cases, the visco-adaptive eye drops in accordance with the present invention may contain combinations of cellulose derivatives, dextrans, gelatin, high molecular weight alcohol, polyols, polyvinyl alcohols and povidone.

Cellulose derivatives include, but are not limited to, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose and methyl cellulose. Derivatives of cellulose can be from 0.05 to about 2.5% by weight of the finished composition.

In addition, the inclusion of dextran or its derivatives is possible. For example, in accordance with the present invention, it is possible to use Dextran 70. Typically, concentrations of about 0.1% dextran can be used with another polymeric anti-irritant agent and delivery system adopted in the present invention.

It is also possible to use gelatin. When used, gelatin can be about 0.01% by weight.

Polyols may contain glycerol, polyethylene glycol 300, polyethylene glycol 400, polysorbate 80 and propylene glycol. Typically, the concentration of polyols is from 0.05 to about 1% by weight of the composition. In addition, a glycerol content of from 0.05% to about 0.5% by weight is possible.

Polyvinyl alcohol (usually in concentrations from 0.1 to about 4%) and providone in concentrations from 0.1 to 2% can also be used.

The percentages by weight indicated above may vary under certain conditions, which will be assessed by a person qualified in the relevant field and this disclosure document.

In certain use cases, phosphate or other buffering agents can be used in the formulation to provide a pH ranging from 6.0 to about 8.0. Sodium chloride or other salts can be used in certain formulations to provide an osmotic concentration of the solution in the range from 130 to about 380 mOsmol / kg. Water may be used to provide the aquatic environment.

In some applications, formulations may be formulated with or without preservatives, depending on the packaging of the final product to maintain sterility. Some packaging options include: separate single-dose containers without preservatives, multi-dose containers with preservatives, and multiple-dose containers (airtight) without preservatives, as well as syringes or ampoules.

In some applications, the hyaluronic acid used has a molecular weight of from 1.4 million to about 2.0 million daltons.

In some applications used in eye surgery, as described above, hyaluronic acid has a molecular weight of from 2 to about 15 million daltons, or preferably from 10 to about 25 million daltons, or (more preferably) from 10 to 15 million daltons .

In some applications, hyaluronic acid is present in a concentration of from 0.05 to about 0.5%.

In some applications, biofermented hyaluronic acid is provided, which eliminates the need to use an animal source for molecules. This reduces the risk of viral or other biological contamination of hyaluronic acid.

In some applications, in combination with hyaluronic acid, irritant-reducing agents, also known as dopants, are provided. For example, polyols, as well as polyvinyl alcohol and povidone, can be used as dopants, since they have a lower viscosity and, therefore, are less likely to cause discomfort or blurred vision. In addition, these substances provide longer retention times on the cornea of the eye. Thus, in some applications, polyols will be used in solutions for contact lenses, day and night eye drops or for the treatment of dry keratoconjunctivitis mild or moderate or dry keratitis, as well as in veterinary preparations, the use of which depends on the visual acuity of the animals in their active period, as well as to alleviate the symptoms of dry keratitis at night or for use in refractive surgery using a laser.

In some applications, in combination with hyaluronic acid, the use of cellulose derivatives as dopants is contemplated. For example, cellulose derivatives, which have a higher viscosity, can be used for keratoconjunctivitis requiring bed rest, during and after surgery, for the treatment of dry keratoconjunctivitis mild or moderate, as well as in veterinary preparations, the use of which initially does not depend on the visual acuity of animals .

In some examples, the compositions can be developed in aqueous mixtures and / or solution, as described in table 1.

Table 1: Ingredient amount Hyaluronic acid 1.5 mg / ml Glycerol 2.0 mg / ml NaCl 8.5 mg / ml Dibasic phosphate 0.27 mg / ml Monobasic Phosphate 0.04 mg / ml

Example 1.1

In one example, the composition shown in Table 1 is used to lubricate the eyes of a patient undergoing refractive surgery using a laser and other surgical procedures. Examples of eye surgery include corneal transplantation, cataracts, implantation of an artificial lens, glaucoma and retinal surgery. During the operation, the surgeon does not need to apply re-irrigation as often as when using any of the available substitute formulations.

Example 1.2

In another example, the composition described in Table 1 is used in a patient with dry eye syndrome or other similar dry conditions, as well as with minor, moderate or severe irritation caused by a disease, harmful environmental conditions, lack of natural tear formation, or working conditions, for example, prolonged use of the computer, which leads to a reduction or complete cessation of the blinking process, and then to insufficient moisture, the appearance of dryness and irritation. The patient has a relief of symptoms of dry keratitis, as a result of which the need to use eye drops disappears as often as with any of the available substitute solutions.

Example 1.3

In another example, the composition shown in Table 1 is used to moisten the eyes of a patient suffering from dry keratitis caused by air travel, environmental conditions, wearing contact lenses, or causes associated with an allergic reaction. The patient has a relief of symptoms of dry keratitis, as a result of which the need to use eye drops disappears as often as with any of the available substitute solutions.

Thus, formulations in which hyaluronic acid and irritation-reducing agents and / or a method for their storage and delivery without preservatives are combined are provided to patients undergoing surgery on the organs of vision or suffering from irritation of dry eyes. To treat the corresponding symptoms of dryness, visco-adaptive eye drops are provided without the use of preservatives with improved viscosity and the introduction of moisturizing sedatives into the eye. Moreover, these options are also commonly used to treat ear, nose, and throat diseases.

Example 2

In an application example, preservative-free otorhinolaryngological preparations can be stored in tanks and dispensed from them using the one-way valve block of a continuous seal and the delivery system described in this invention. For example, medicines for nasal use and mainly nasal sprays, ear creams and drops for external use, ear drops containing steroids and antibiotics, nasal drops and drops containing 0.25% phenylephrine and 30 mg pseudoephedrine can be stored in reservoirs and distributed from them using a one-way valve block continuous sealing and the supply system described in this invention.

Further, in selected embodiments for use in the nasal cavity and sinus, a composition that contains hyaluronic acid and emollients, together with appropriate excipients, is stored and distributed in the tanks using the one-way valve block of a continuous seal and the delivery system described in this invention. Examples and methods of manufacturing such compositions are given below.

In the present compositions, hyaluronic acid and / or its derivatives are used, which can be presented in the form of its salts of sodium, potassium, calcium, zinc or other forms with a concentration which in certain examples can vary from 0.05 to about 3.0% and with a molecular weight ranging from 300 thousand to about 7 million daltons in its native form and up to about 25 million daltons in a form with a transverse intermolecular bond.

In most cases, a visco-adaptive formulation comprising from 10 million to about 15 million, or from 10 million to about 25 million daltons of high molecular weight hyaluronic acid, in combination with the low molecular weight sedative described below, provides significant benefits during or after nasal or transnasal surgery. For example, a high molecular weight visco-adaptive hyaluronic acid solution can be physically injected into the patient's nasal cavity, eliminating the difficulties associated with the delivery of moisturizers and / or release fluids using conventional methods. In addition, the structure with a transverse intermolecular bond, presented in high molecular weight hyaluronic acid, allows the use of its lower concentration.

In the selected examples, the use of from 1.0 to about 2.0 or from 1.5 to about 2.0 million daltons of hyaluronic acid has a significant effect in the compositions for treating dry nasal membranes and for other non-surgical and postoperative use. For example, by increasing the retention time, the negative consequences of frequent use of saline solutions used to maintain a minimum level of comfort and moisture content are minimized. Another significant physical and medical advantage of this invention is the need for a smaller amount of applied substance used to maintain comfort, moisture, hydration and protection.

Such visco-adaptive formulations can be used to treat dry nasal membranes, sneezing and / or irritation caused, for example, by colds, flu, allergies, dust or smoke, air pollution, the use of air conditioning or heating in winter, high above sea, travel, oxygen therapy, as well as for the treatment of dryness caused by certain medications, dry nose due to iatrogenic disease, surgery, etc. Menen anesthetics.

In further embodiments, hyaluronic acid and / or its derivatives in combination with glycerin and / or any other sedatives plays the role of an improved mucoadhesive substance, providing increased retention time and better coverage.

In other examples of application, it is possible to use visco-adaptive formulations for administering drugs using a delivery pump or device without using preservatives in nasal tissues in order to increase bioavailability and retention time by several times (up to 10 or more). For example, antibiotic retention times in nasal tissues can be increased from minutes to hours. Among the drugs that can be administered in this way, drugs for treating allergies, steroid drugs, antibiotics, non-steroidal anti-inflammatory drugs, inflammatory, anti-inflammatory, antifungal and other drugs that are administered topically to the nasal tissue or sinus.

In certain cases, visco-adaptive solutions for nasal use in accordance with the present invention may contain combinations of cellulose derivatives, dextrans, gelatin, polyols, high molecular weight alcohol, polyvinyl alcohols and povidone.

Examples of the application of this invention provide several unexpected advantages, among which, for example, excellent coating, improved mucoadhesive tension on the surfaces of the nasal cavity and sinus, increased retention time, excellent hydration, easier application, more even coverage of the surfaces of the nasal membrane and sinus during surgery and after it, as well as multi-dose, multi-purpose distribution of the drug without the use of preservatives.

In addition, a high molecular weight visco-adaptive hyaluronic acid solution can be physically injected into the patient’s nasal cavity, eliminating the difficulties associated with the delivery of moisturizing fluids using conventional methods, and providing a more even coverage of the surfaces of the nasal membrane and sinus, including hard-to-reach cavities and tissues during surgery operations.

Moreover, a preservative-free delivery system has been developed that can contain and dispense many doses of moisturizing liquid for nasal use while protecting the composition from contamination and / or deterioration, eliminating the need for additional costs and waste associated with the use of disposable dispensing devices .

In certain cases, visco-adaptive solutions for nasal use in accordance with the present invention may contain combinations of cellulose derivatives, dextrans, gelatin, polyols, polyvinyl alcohols and povidone.

Cellulose derivatives include, but are not limited to, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose and methyl cellulose. Derivatives of cellulose can be from 0.05 to about 2.5% by weight of the finished composition.

In addition, the inclusion of dextran or its derivatives is possible. For example, in accordance with the present invention, it is possible to use Dextran 70. Typically, concentrations of about 0.1% dextran can be used with another polymeric anti-irritant agent and delivery system adopted in the present invention.

It is also possible to use gelatin. When used, gelatin can be about 0.01% by weight.

Polyols may contain glycerol, polyethylene glycol 300, polyethylene glycol 400, polysorbate 80 and propylene glycol. Typically, the concentration of polyols is from 0.05 to about 1% by weight of the composition. In addition, a glycerol content of from 0.05% to about 0.5% by weight is possible.

Polyvinyl alcohol (usually in concentrations from 0.1 to about 4%) and povidone in concentrations from 0.1 to about 2% can also be used.

The percentages by weight indicated above may vary under certain conditions, which will be assessed by a person qualified in the relevant field and this disclosure document.

In certain examples of use, phosphate or other buffering agents can be used in the formulation to provide pH values ranging from 5.0 to about 8.0, preferably from 6.0 to about 8.0. Sodium chloride or other salts can be used in certain formulations to provide an osmotic concentration of the solution in the range from 270 to about 350 mOsmol / kg. Water may be used to provide the aquatic environment.

In some applications, formulations may be formulated with or without preservatives, depending on the packaging of the final product to maintain sterility. Some packaging options include: separate single-dose containers without preservatives, multi-dose containers with preservatives, and multiple-dose containers (airtight) without preservatives, as well as syringes or ampoules.

In some applications, the hyaluronic acid used has a molecular weight of from 1.0 million to about 2.0 million, or from 1.4 million to 2.0 million daltons.

In some applications useful in operations on the nasal or sinus, as described above, hyaluronic acid has a molecular weight of from 10 to about 25 million daltons or (more preferably) from 10 to 15 million daltons.

In some applications, hyaluronic acid is present in a concentration of from 0.05 to about 0.5%. In some other applications useful for surgical and postoperative purposes, hyaluronic acid is present in a concentration of from about 0.15 to about 0.5%. In other applications used to treat dry nasal cavity, hyaluronic acid is present in a concentration of from about 0.15 to about 0.3%, or from about 0.05 to about 0.5%.

The percentages by weight indicated above may vary under certain conditions, which will be assessed by a person qualified in the relevant field and this disclosure document.

In some applications, formulations may be formulated with or without preservatives, depending on the packaging of the final product to maintain sterility. Some storage and / or administration options include: separate single dose reservoirs without preservatives, multiple dose reservoirs with preservatives and multiple dose reservoirs (airtight) without preservatives, as well as syringes or ampoules.

In some applications, biofermented hyaluronic acid is provided, which eliminates the need to use an animal source for molecules. This reduces the risk of viral or other biological contamination of hyaluronic acid.

In some applications, sedatives, also known as dopants, are provided in combination with hyaluronic acid. For example, polyols, as well as polyvinyl alcohol and povidone, can be used as dopants, since they have a lower viscosity and, therefore, are less likely to cause discomfort when used. In addition, these substances provide longer retention times in nasal tissue.

In some applications, in combination with hyaluronic acid, the use of cellulose derivatives as dopants is contemplated. For example, cellulose derivatives that have a higher viscosity will be used for bed rest, for surgical and postoperative purposes, for the treatment of mild or moderate degree of dryness of the nasal cavity

In some examples, the compositions can be developed in aqueous mixtures and / or solution, as described in table 1.

In certain applications, hyaluronic acid and / or its derivatives may be administered alone or in combination with other sedative (anti-irritant) agents as a visco-adaptive fluid in a pumping device using the one-way valve block and delivery system described in this invention for direct injection into the nostrils with to optimize use and hygiene without direct contact with the affected area. Moreover, this product can also be supplied as a tubular device or reservoir using a one-way valve and the feed system of this invention. In addition, the use of a pumping device provides excellent hygienic coverage of the affected area and ease of use without the need for direct contact with the affected area. Thus, examples of the use of the present invention also relate to the use of hyaluronic acid and / or its derivatives alone or in combination with other irritation-reducing agents in a pumping device, in particular for nasal or transnasal indications.

Examples of the application of this invention provide several unexpected advantages, among which, for example, excellent coverage, convenience for the patient, excellent hydration and hydration, as well as multi-dose, multi-purpose distribution of the drug without the use of preservatives.

For example, in application examples of the invention, excellent coverage of the surface of the tissues of the nasal membrane and sinus is provided with an increased in vivo retention time caused, at least in part, by a new combination of hyaluronic acid with a specific size range, as described above, and / or its derivatives with other irritating agents, including, but not limited to, glycerin.

Moreover, the convenience for the patient is ensured by the elastic properties of hyaluronic acid and / or its derivative components, which is achieved by the new sizes and concentrations of acid used in the embodiments.

In addition, the excellent moisturizing ability of hyaluronic acid and / or its derivatives, achieved thanks to the new sizes and concentrations of hyaluronic acid used in the application examples, allows the acid to play the role of a molecular sponge, which absorbs and releases irritants and water as necessary for the tissue .

Moreover, a feed system without preservatives was developed, in which several doses of solutions for nasal use can be contained and distributed, while protecting the composition from contamination and / or spoilage, which eliminates the need for additional costs and waste associated with the use of disposable dosing devices.

Such visco-adaptive formulations can be used to treat dryness of the nasal membrane caused, for example, by colds, flu, allergies, dust or smoke, air pollution, use of air conditioning or heating in winter, high altitude, travel, oxygen therapy as well as for the treatment of dryness caused by certain medications and iatrogenic dryness of the nasal cavity, as well as dryness caused by surgery iey and the use of anesthetics.

Example 2.1

The composition shown in Table 1 is used for delivery to the nasal region or sinus of a patient undergoing surgery on the nasal cavity or sinus. During the operation, the surgeon is much easier to inject moisturizing fluid into the nasal cavity and sinus. In addition, the visco-adaptive solution has an excellent retention time on the nasal tissue, which provides longer coverage, moisturizing, lubrication and protection of the delicate tissue of the nasal cavity and the removal of unnecessary, surgically removed tissue particles, especially the blood remaining after the operation.

Example 2.2

The composition shown in Table 1 is used to deliver into the ear cavity of a patient undergoing surgery on the middle or inner ear. During the operation, it is much easier for the surgeon to inject moisturizing fluid into the inner and outer ear areas. In addition, the visco-adaptive solution has an excellent retention time on the tissue to provide greater moisture, protection, lubrication and prevent unwanted adhesion of tissue particles during the postoperative period. Thus, a visco-adaptive solution can accelerate the healing process by preventing the adhesion of unwanted postoperative tissue particles, such as blood residues, remaining after surgery.

Example 2.3

The composition shown in Table 1 is used to deliver to the patient's nasal region or sinus after surgery on the nasal cavity or sinus. The patient has a relief of symptoms of dryness of the nasal cavity, as a result of which he no longer needs to use a nasal solution as often as in the case of saline or any other solutions that have different physical properties with less retention time.

Example 2.4

The composition shown in Table 1 is used to deliver to the nasal passage or sinus of a patient suffering from dry nose due to air travel, environmental conditions, the use of certain medications or in connection with an allergic reaction. The patient has a relief of symptoms of dryness of the nasal cavity, as a result of which he no longer needs to use nasal fluid as often as with any of the available substitute solutions.

Thus, compositions in which hyaluronic acid and irritating agents and / or a method for their storage and administration without preservatives are combined are provided to patients suffering from dry nasal cavity. To treat the corresponding symptoms of dryness, a visco-adaptive nasal solution without preservatives with improved, longer hydration, as well as protective and lubricating properties is provided. Moreover, these applications are also commonly used for the treatment of diseases of the ear, nose, mouth and throat, as well as for vaginal use, which requires moisturizing fluid.

Although this system is intended for use with various formulations that do not contain preservatives, its use is also possible with those solutions in which the use of preservatives is provided.

Claims (54)

1. One-way valve block continuous sealing with a feed system for the distribution of fluid substance, comprising the following components:
a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for receiving a fluid substance into the passage channel and at least one outlet from the passage channel,
(ii) a hollow flexible membrane with two ends, the first of which has a greater thickness than the second end, while the hollow flexible membrane is located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane outward from the outer surface of the above inner core;
a cover, which includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and in which, after the pressure on the fluid substance is stopped, the first end of the hollow flexible membrane returns back, fitting tightly to the outer surface of the inner core before the remainder of the hollow flexible membrane returns to the outer surface of the above inner core, where the reservoir is filled with no preservatives an agent for treating diseases of the eyes or nasal cavity that contains hyaluronic acid or its derivatives. 2. The one-way valve block of a continuous seal with a feed system according to claim 1, where the hollow flexible membrane has an axially elongated continuous continuous strip in its first end portion and surrounds the core. 3. The one-way continuous seal valve block with a delivery system according to claim 1, wherein the aforementioned membrane has an elongated radially outwardly extending flange in a second end portion that abuts the passage channel of the inner core, and the cap also has an elongated radially outwardly extending flange that presses the flange on the membrane, providing tight contact with the elongated flange extending radially outward at the opening of the passage channel leading to the inner core. 4. The one-way valve block of a continuous seal with a supply system according to claim 3, where the coupling and the connecting element of the reservoir provide a reliable connection of the valve block to the reservoir. 5. The one-way valve block of a continuous seal with a feed system according to claim 4, where the connecting element is provided with a screw thread, which is associated with the coupling. 6. The one-way valve block of a continuous seal with a supply system according to claim 4, where the coupling and the connecting element of the tank provide a reliable connection of the valve block to the tank and forced fixation, preventing the possibility of opening the tank. 7. The one-way valve block of a continuous seal with a supply system according to claim 1, where the outlet in the lid is designed so that it allows you to distribute a predetermined amount of fluid substance. 8. The one-way valve block of a continuous seal with a supply system according to claim 1, where the outlet in the lid is made of soft material. 9. The one-way valve block of a continuous seal with a supply system according to claim 1, where the outlet in the lid is made of flexible material. 10. The one-way valve block of a continuous seal with a supply system according to claim 1, where the cover is formed of an internal axially elongated flexible component that is closed to the side by an axially elongated rigid plastic sheathing. 11. The one-way valve block of a continuous seal with a supply system according to claim 1, where the top cover is fitted to seal the valve block, sufficient to protect it from external contamination during storage. 12. The one-way valve block of a continuous seal with a supply system according to claim 1, where at least two holes lead from the passage channel through the inner core to the inner surface of the flexible membrane. 13. The one-way valve block of a continuous seal with a supply system according to claim 1, where the reservoir contains a flexible reservoir, which can proportionally change its volume as a fluid substance is dispensed from it. 14. The one-way valve block of a continuous seal with a delivery system according to item 13, where the aforementioned flexible tank may be in the form of a bellows, flexible pipe or inner bag. 15. The one-way valve block of a continuous seal with a supply system according to claim 1, where an axially elongated housing closes the tank on the side. 16. The one-way valve block of a continuous seal with a feed system according to claim 15, wherein the housing has an axially elongated slot for applying a distributing pressure to the drive of the flexible reservoir. 17. The one-way valve block of continuous sealing with a supply system according to claim 1, where the lid has a closed outlet that opens to distribute the fluid substance under the action of distributing pressure on the tank. 18. The one-way valve block of a continuous seal with a delivery system according to claim 17, wherein the outlet in the lid does not allow fluid to pass through and does not hold fluid from the inside of the outlet. 19. The one-way valve block of a continuous seal with a supply system according to claim 1, where the inner core is connected to the pump unit and the drive so that the fluid substance is distributed from the outlet after reducing pressure on the drive. 20. The one-way valve block of a continuous seal with a delivery system according to claim 1, wherein the reservoir is filled with a preservative-free ophthalmic solution that contains hyaluronic acid or its derivatives and one or more irritating agents. 21. The one-way continuous seal valve block with a delivery system according to claim 20, where hyaluronic acid or its derivatives are characterized by a molecular weight of from about 300 thousand to about 7 million daltons. 22. The one-way continuous seal valve block with the feed system of claim 20, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 1.4 million to about 2.0 million daltons. 23. The one-way continuous seal valve block with a delivery system according to claim 20, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 2 million to about 15 million daltons. 24. The one-way continuous seal valve assembly with the delivery system of claim 20, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 10 million to about 15 million daltons. 25. The one-way valve block of a continuous seal with a feed system according to claim 20, where hyaluronic acid or its derivatives are characterized by a molecular weight of from about 10 million to about 25 million daltons. 26. The one-way valve block of a continuous seal with a feed system according to claim 20, where hyaluronic acid or its derivatives are characterized by a concentration of about 0.05-0.5%. 27. The one-way valve block of a continuous seal with a supply system according to claim 20, where hyaluronic acid or its derivatives have a concentration of about 0.05-3%. 28. The one-way valve block of a continuous seal with a feed system according to claim 20, where hyaluronic acid or its derivatives are obtained in the process of biofermentation. 29. The one-way valve block of continuous sealing with the delivery system according to claim 20, where the reservoir is filled with a preservative-free eye solution containing hyaluronic acid or its derivatives and one or more irritating agents, as well as a substance selected from one or more of the following substances: 0.25% / 0.50% timolol, 0.1% brimonidine tartrate, 0.03% bimatoprost and 0.004% grass 30. The one-way valve block of continuous sealing with a delivery system according to claim 20, in which the reservoir is filled with a preservative-free eye solution containing hyaluronic acid or its derivatives and one or more irritating substances, as well as a substance selected from one or more of the following substances : 0.1% olopatadein hydrochloride and 1% prednisone acetate. 31. The one-way valve block of continuous sealing with a delivery system according to claim 20, where the reservoir is filled with a preservative-free eye solution containing hyaluronic acid or its derivatives and one or more irritating agents, as well as a substance selected from one or more of the following: 0.5% ketorolac and 0.1% diclofenac. 32. The one-way continuous seal valve block with the delivery system of claim 20, wherein the irritant reducing agent is selected from one or more of the following substances: cellulose derivatives, dextrans, gelatin, polyols, polyvinyl alcohols and povidone. 33. The one-way valve block of continuous sealing with a delivery system according to claim 1, wherein the reservoir is filled with a preservative-free nasal cavity treatment agent containing hyaluronic acid or its derivatives and one or more irritating agents. 34. A one-way continuous seal valve block with a delivery system according to claim 33, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 1.4 million to about 2.0 million daltons. 35. A one-way continuous seal valve block with a delivery system according to claim 33, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 1 million to about 2 million daltons. 36. The one-way continuous seal valve block with a delivery system according to claim 33, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 10 million to about 15 million daltons. 37. The one-way valve block of a continuous seal with a delivery system according to claim 33, wherein the hyaluronic acid or its derivatives are characterized by a molecular weight of from about 10 million to about 25 million daltons. 38. The one-way valve block of a continuous seal with a delivery system according to claim 33, wherein the hyaluronic acid or its derivatives are characterized by a concentration in the range of about 0.05-0.5%. 39. The one-way valve block of a continuous seal with a delivery system according to claim 33, wherein hyaluronic acid or its derivatives are characterized by a concentration in the range of about 0.15-3%. 40. The one-way valve block of a continuous seal with a delivery system according to claim 33, wherein hyaluronic acid or its derivatives are characterized by a concentration in the range of about 0.15-0.5%. 41. The one-way valve block of a continuous seal with a feed system according to claim 33, wherein the hyaluronic acid or its derivatives are obtained in the course of biofermentation. 42. The one-way valve block of continuous sealing with a delivery system according to claim 33, wherein the reservoir is filled with a preservative-free ophthalmic solution containing hyaluronic acid or its derivatives and one or more irritating agents, as well as a substance selected from one or more of the following: 0.25% / 0.50% timolol, 0.1% brimonidine tartrate, 0.03% bimatoprost and 0.004% grass 43. The one-way valve block of continuous sealing with a delivery system according to claim 33, wherein the reservoir is filled with a preservative-free ophthalmic solution containing hyaluronic acid or its derivatives and one or more irritating agents, as well as a substance selected from one or more of the following: 0.1% olopatadine hydrochloride and 1% prednisolone acetate. 44. The one-way valve block of continuous sealing with a delivery system according to claim 33, wherein the reservoir is filled with a preservative-free ophthalmic solution containing hyaluronic acid or its derivatives and one or more irritating agents, as well as a substance selected from one or more of the following: 0.5% ketorolac and 0.1% diclofenac. 45. The one-way valve block of continuous sealing with a delivery system according to claim 33, wherein the irritant reducing agent is selected from one or more of the following substances: cellulose derivatives, dextrans, gelatin, polyols, polyvinyl alcohols, polysorbate 80 and povidone. 46. The one-way valve block of a continuous seal with a delivery system according to claim 1, where the one-way valve block of a continuous seal and a delivery system can distribute a plurality of doses of a preparation in which no preservatives are used. 47. A one-way valve block of a continuous seal with a feed system for distributing a fluid substance, comprising the following components: a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for receiving a fluid substance into the passage channel and at least one exit hole from the passage channel,
(ii) a hollow flexible membrane with two ends, the first of which is thicker than the second end, the hollow flexible membrane being located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane outward from the outer surface of the above inner core;
a lid that includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and
in which, after the supply of pressure to the fluid is stopped, the first end of the hollow flexible membrane comes back tightly against the outer surface of the inner core before the rest of the hollow flexible membrane returns to the outer surface of the aforementioned inner core,
where the reservoir is filled with a preservative-free treatment for diseases of the eye or nasal cavity, which contains hyaluronic acid or its derivatives and one or more irritating agents. 48. A one-way valve block of a continuous seal with a feed system for distributing a fluid substance, comprising the following components: a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for receiving a fluid substance into the passage channel and at least one exit hole from the passage channel,
(ii) a hollow flexible membrane with two ends, the first of which is thicker than the second end, the hollow flexible membrane being located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane outward from the outer surface of the above inner core;
a lid that includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and
in which, after the supply of pressure to the fluid is stopped, the first end of the hollow flexible membrane comes back tightly against the outer surface of the inner core before the rest of the hollow flexible membrane returns to the outer surface of the aforementioned inner core,
where the reservoir is filled with a preservative-free treatment for diseases of the eye or nasal cavity, which contains hyaluronic acid or its derivatives and one or more irritating agents. 49. A feed system including:
a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for passing a fluid substance into the passageway and at least one outlet opening from the passageway,
(ii) a hollow flexible membrane with two ends, the first of which has a greater thickness than the second, while the hollow flexible membrane is located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane out from the outer surface of the above inner core;
a lid that includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and
in which, after the supply of pressure to the fluid is stopped, the first end of the hollow flexible membrane comes back tightly against the outer surface of the inner core before the rest of the hollow flexible membrane returns to the outer surface of the aforementioned inner core,
where the reservoir is filled with a preservative-free treatment for diseases of the eyes or nasal cavity, which contains hyaluronic acid or its derivatives. 50. A one-way valve block of a continuous seal with a feed system for distributing a fluid substance, comprising the following components:
a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for receiving a fluid substance into the passage channel and at least one outlet from the passage channel,
(ii) a hollow flexible membrane with two ends, the first of which is thicker than the second end, the hollow flexible membrane being located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane outward from the outer surface of the above inner core;
a lid that includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and
in which, after the supply of pressure to the fluid is stopped, the first end of the hollow flexible membrane comes back tightly against the outer surface of the inner core before the rest of the hollow flexible membrane returns to the outer surface of the aforementioned inner core,
moreover, at least one component of the inner core of the hollow flexible membrane and cover contains antimicrobial material; and
where the reservoir is filled with a preservative-free treatment for diseases of the eye or nasal cavity, which contains hyaluronic acid or its derivatives and one or more irritating agents. 51. A one-way continuous valve block seal with a feed system according to claim 50, wherein the antimicrobial material is selected from one of the substances: silver ions contained within the ceramic crystal holder, and ionic silver release components. 52. A one-way valve block of a continuous seal with a feed system for distributing a fluid substance, comprising the following components:
a reservoir for storing a fluid substance with an opening;
a valve block connected to the opening of the tank and comprising:
(i) an inner core with an inlet for receiving a fluid substance into the passage channel and at least one outlet from the passage channel,
(ii) a hollow flexible membrane with two ends, the first of which is thicker than the second end, the hollow flexible membrane being located above the outer surface of the inner core, and after applying pressure, the fluid substance passes through at least one hole and stretches the above membrane outward from the outer surface of the above inner core;
a cover, which includes a flexible membrane and has an outlet for distributing fluid substance from the valve block when pressure is applied to the fluid substance, and in which, after the pressure on the fluid substance is stopped, the first end of the hollow flexible membrane returns back, fitting tightly to the outer surface of the inner core before the remainder of the hollow flexible membrane returns to the outer surface of the above inner core,
where at least one of the components of the hollow flexible membrane and the cover contains a hydrophobic material. 53. The one-way valve block of a continuous seal with a feed system according to claim 52, wherein said hydrophobic material is selected from one of materials: a positively charged material, a material with low friction, a material with high surface tension, or a material with moisture repellent properties. 54. The one-way valve block of a continuous seal with a feed system according to claim 53, wherein said low friction material is Teflon.

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