JP2006305347A - New method for administering ophthalmic solution - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an administering apparatus for liquid products, especially medical products, such as an ophthalmic solution. <P>SOLUTION: The administering apparatus is equipped with a housing having an opening part, a container for liquids having a supply nozzle which is practically statically composed for the housing, an administering chamber having a valve including first and second orifices, a mechanism enabling the liquid to be discharged through the second orifice, and a penetration path comprised for passing the discharged liquid in a different direction from the supply nozzle toward the outside of the opening part, (i) the mechanism is equipped with a movable element capable of moving toward the housing or the frame between at least first position where the flows of the first orifice of the administering chamber and the supply nozzle are communicated, and the second position where the flows of the second orifice and the penetration path are communicated, and (ii) the movable element can suck the liquid at the first position through the first orifice or discharge the liquid at the second position through the second orifice in the structure. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a dispensing device for liquid products, in particular pharmaceutical products such as eye drops. According to this design, no liquid can remain in the device during the discharge of the liquid and therefore no loss of quality of the solution remaining in the device during dosing treatment will occur. That is particularly important for pharmaceutical products, especially for eye drops. In addition, medication is more accurate and patients are overdosed, reducing the likelihood of eye irritation.

  The principles of the present invention can be used in many areas, but for convenience, will be described primarily in the context of eye fluid therapy. Weinreb RN and Khow PT, Lancet, 2004, 363, 171-1720 discuss various eye conditions, such as primary open-angle glaucoma, which is incorporated herein by reference. In general, medical formulations need to be given a suitably defined volume to ensure that a specified amount is administered or absorbed. Absorption into non-target tissues, or improper physiological effects of the whole body due to excess fluid drained through the lacrimal duct into the larynx, or malfunctions due to overflow of the face and clothing. Surplus cannot be tolerated. In addition, price considerations are given to expensive drugs. As an example, the treatment of glaucoma requires frequent administration of, for example, prostaglandins, beta-blockers, or other expensive active ingredients, all of which are applied to other body tissues except the eye. When absorbed, it has an effect other than the desired pressure release. Small doses are also adversely affected by slight, uncontrolled or dead space in the dispensing device used. In addition, the components of the medical formulation can be sensitive to degradation or absorption due to prolonged exposure to the materials and extended surfaces present in the administration device. Similar considerations apply to aseptic storage. With regard to flow quality, proper administration of small amounts is complicated because the active ingredient cannot enter the eye other than through a limited area of the cornea. It is also necessary that the entire dose be administered before the eyelid is closed by the induced blink reflex.

  Numerous devices are already known that give a specified amount of a liquid medical product, such as eye drops to the surface of the eye, to a body part. These devices generally utilize the principle of a syringe, which is pre-filled with a specified amount of liquid or to aspirate said amount of liquid contained in another container It can be calibrated or connected to a stationary container that is in permanent communication with the dosing chamber of the syringe, for example, as described in one of the embodiments of US Pat. No. 4,623,337. It can be seen that the permanent supply from the container to the dosing chamber by gravity means that neither the accuracy of the amount of liquid released nor its sterility can be guaranteed. In these devices, the pressure applied to the plunger manually or automatically generally acts in the same direction as the liquid jet, as described, for example, in the Patent Cooperation Treaty Publication WO 92/20455.

  The jet direction can be deflected from time to time by a curved tube, but in that case it is difficult to control the force for the jet to reach its target. For example, in this type of device similar to that disclosed in French patent FR 2647757 for food or cosmetics in liquid or pasty form, it is not important to keep a given discharge pressure.

However, in the case of ophthalmic solutions, not only for the obvious reasons of safety and efficacy of treatment, but also to enable the control of the impact pressure of the liquid jet on the eye, the dosage released with high precision Control is very important and it gives a fixed distance to the liquid discharge orifice by several devices, as disclosed for example in US Pat. No. 4,623,337 and US Pat. No. 5,836,911. Attempts have been made to achieve this by using eyepieces or spacing members applied around the target. However, it can be seen that when manually applying pressure directly to the plunger, these devices cannot always reproduce the impact force of the liquid jet.
U.S. Pat. No. 4,623,337 Patent Cooperation Treaty Publication WO92 / 20455 French Patent No. FR 2647757 US Pat. No. 5,836,911 Weinreb RN and Khow PT, Lancet, 2004, 363, 1711-1720

  With this design, after the exact amount of liquid has been released, there is no significant residue left behind, an important risk associated with the prior art, namely the loss of quality of the residual solution in the device during the administration period. Can be eliminated. Both accurate liquid volume release and solution quality maintenance are particularly important for pharmaceutical products, especially for eye drops. This design also provides accurate horizontal dosing of the liquid to the target surface (such as the eye) with minimal effort and with minimal dependence on the patient's dexterity. This design ensures that dosing treatment is required only once and minimizes dosing failures associated with the prior art. This design allows for more efficient use by the patient and also increases the risk of infection due to (excessive exposure to the active drug, increased eye irritation due to increased irritants in the formulation, increased contact frequency with the eye) Reduce medical safety risks associated with multiple attempts to administer medications.

This design also allows for horizontal administration of liquids, as is possible for those who have difficulty tilting the head necessary for successful instillation using conventional techniques.
Thus, while prior art dispensing devices provide individual solutions to a particular problem, none of them can solve all of the aforementioned problems simultaneously.

The present invention is a device for administering a liquid product comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second orifice. A dosing chamber having a valve, d) a mechanism configured to allow discharge of liquid through the second orifice, and e) opening the discharged liquid in a direction different from the supply nozzle. A through passage configured to pass out of the section, i) a mechanism at least a first position where the flow of the first orifice of the dosing chamber and the flow of the supply nozzle communicate, and a second orifice And a second position where the flow of the through passage communicates with the housing or the frame, and ii) the mechanism is movable Configured to aspirate liquid through the first orifice when the element is in the first position and to discharge liquid through the second orifice when the moving element is in the second position Related to the device.

One embodiment of the invention relates to the apparatus, wherein the housing optionally comprises an eyepiece.
Another embodiment of the invention relates to the apparatus, wherein the eyepiece optionally comprises an eyepiece ring.

Another embodiment of the invention relates to the device, wherein the eyepiece ring is made of a thermoplastic elastomer or silicone.
In another embodiment, the present invention relates to an apparatus that includes at least one actuator and is adapted to operate a mechanism.

One embodiment of the invention relates to an apparatus, wherein the actuator is configured to be operated by using a manual force.
Another embodiment of the invention relates to the apparatus, wherein the actuator moves the moving element between a filling position when the moving element is in the first position and a discharge position when the moving element is in the second position. It is adapted to move or carry.

  In another embodiment, the invention relates to an apparatus, wherein the actuator is substantially adapted to perform a continuous motion, during which the mechanism includes at least a suction step, a first position, A movement of the moving element between the second positions is performed.

In another embodiment, the present invention relates to an apparatus, wherein the actuator allows the moving element to move substantially continuously between the first position and the second position.
One embodiment of the invention relates to the apparatus, wherein the actuator allows the moving element to move substantially continuously to fill the dosing chamber with the liquid product in the first position.

One embodiment of the present invention relates to the apparatus, wherein the actuator is configured such that the moving element is capable of substantially continuous movement to release the liquid product from the dosing chamber in the second position.
Another embodiment of the invention relates to the apparatus, wherein the actuator is adapted to provide tactile feedback just prior to the release step in continuous motion.

Another embodiment of the invention relates to the apparatus, wherein the moving element is adapted to move in a substantially vertical direction.
In another embodiment, the present invention relates to an apparatus, wherein the moving element is adapted to move or transport the dosing chamber in a substantially horizontal direction.

In another embodiment, the present invention relates to the apparatus, wherein the dosing chamber comprises a substantially cylindrical barrel defining a concentric barrel axis.
One embodiment of the invention relates to the apparatus, wherein the first orifice is adapted to connect with a suction element.

  Another embodiment of the invention relates to the apparatus, wherein the moving element comprises an aperture, the aperture is adapted to be blocked when the moving element is in the first position, and the moving element is in the second position. Sometimes, the aperture is aligned with the second orifice and opening to discharge fluid.

  In another embodiment, the invention relates to an apparatus, wherein the mechanism sequentially performs aspiration of liquid at a first position, movement of a moving element to a second position, and discharge of liquid at the second position. Have been adapted.

  In another embodiment, the present invention relates to an apparatus, wherein the mechanism is adapted to provide suction by retracting the pump member relative to the return spring and to release by pushing the pump member with the return spring. .

One embodiment of the present invention relates to a device, wherein the mechanism is adapted to return to a starting or resting position after the liquid has been released.
Another embodiment of the invention relates to the apparatus, wherein the mechanism is adapted to return to a starting position or a resting position before the discharge of liquid.

In another embodiment, the invention relates to the apparatus, wherein the supply nozzle is disposed at the proximal end of the container.
In another embodiment, the invention relates to an apparatus, wherein a dosing chamber is in operative communication with a supply nozzle.

One embodiment of the present invention relates to an apparatus, wherein the moving element has a straight cam surface shape.
One embodiment of the invention relates to the apparatus, wherein the moving element has a cam surface.
Another embodiment of the invention relates to the apparatus, wherein the dosing chamber comprises a suction element therein.

Another embodiment of the invention relates to the apparatus, wherein the suction element has a cylindrical shape.
Another embodiment of the invention relates to the device, wherein the suction element is a cannula.
In another embodiment, the invention relates to the apparatus, wherein the suction element is formed from a rigid plastic material.

In another embodiment, the present invention relates to the apparatus, wherein the suction element is formed from polycarbonate (PC).
In another embodiment, the present invention relates to the apparatus, wherein the suction element is formed from metal.

One embodiment of the invention relates to an apparatus, wherein the suction element is formed from acrylonitrile butadiene styrene (ABS).
Another embodiment of the invention relates to the apparatus, wherein the second orifice is adapted to produce a liquid spray.

In another embodiment, the invention relates to an apparatus, wherein the second orifice is adapted to produce a substantially coherent flow.
In other embodiments, the present invention relates to an apparatus, wherein the second orifice is adapted to substantially discharge liquid directly into the air.

In another embodiment, the invention relates to an apparatus, wherein the second orifice is adapted to produce a droplet stream.
In another embodiment, the present invention relates to the apparatus, wherein the droplet stream is a horizontal stream.

The present invention is a method of operating a device for dispensing a liquid product, the device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second orifice. A dosing chamber having a valve, d) a mechanism configured to allow discharge of liquid through the second orifice, and e) opening the liquid to be discharged in a direction different from the supply nozzle. A through passage configured to pass out of the section, i) connecting the first orifice and the nozzle to allow flow, and ii) dispensing through the first orifice. Filling the liquid into the chamber; and iii) releasing the liquid from the dosing chamber through the second orifice to the ocular target. To.

The present invention is a kit for operating a device for administering a liquid product, comprising a device for administering a liquid product, a liquid product, and instructions for use, the device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second orifice. A dosing chamber having a valve, d) a mechanism configured to allow discharge of liquid through the second orifice, and e) opening the discharged liquid in a direction different from the supply nozzle. The present invention relates to a kit including a through passage configured to pass outside the portion.

One embodiment of the invention relates to a kit, wherein the liquid product is an ophthalmic solution.
One embodiment of the invention relates to a kit, wherein the eye drop is a formulation comprising latanoprost, or a pharmaceutically acceptable salt or solvate thereof.

The present invention is a method of treating an ophthalmic condition comprising a device for administering a liquid product, the device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second orifice. A dosing chamber having a valve, d) a mechanism configured to allow discharge of liquid through the second orifice, and e) opening the discharged liquid in a direction different from the supply nozzle. A liquid product comprising a pharmaceutically effective amount of ophthalmic solution.

Another embodiment of the invention relates to the method wherein the ophthalmic solution is a formulation comprising latanoprost, or a pharmaceutically acceptable salt or solvate thereof.
Another embodiment of the present invention is the use of a pharmaceutically effective amount of ophthalmic solution for the treatment of an ophthalmic condition, the ophthalmic solution being provided to a patient via the device, the device A) a housing or frame having an opening; b) an ophthalmic solution container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second. A dosing chamber having a valve comprising a plurality of orifices, d) a mechanism configured to allow the discharge of ophthalmic liquid through a second orifice, and e) a dispensed ophthalmic liquid with a supply nozzle The present invention relates to a usage comprising: a through passage configured to pass out of the opening in a different direction.

In another embodiment, the invention relates to its use, wherein the eye drop comprises the active ingredient latanoprost.
In another embodiment, the present invention relates to its use, wherein the ophthalmic solution comprises a combination of the active ingredients latanoprost and timolol maleate.

  One embodiment of the present invention is a kit for use in the treatment of an ophthalmic condition, comprising an eye drop, a device for administering the eye drop, and instructions for use, the device comprising: a) a housing or frame having an opening; b) an ophthalmic solution container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first orifice and a second orifice. A dosing chamber having a valve, d) a mechanism configured to allow the discharge of ophthalmic liquid through a second orifice, and e) a direction in which the ophthalmic liquid to be discharged is different from the supply nozzle The present invention relates to a kit including a through passage configured to pass outside the opening.

In another embodiment, the present invention relates to a kit, wherein the ophthalmic solution comprises latanoprost.
In another embodiment, the present invention relates to a kit, wherein the ophthalmic solution comprises latanoprost and timolol maleate.

  One embodiment of the present invention is an ophthalmic composition comprising a pharmaceutically effective amount of latanoprost solution and a device for holding the latanoprost solution, the device comprising: a) a housing or frame having an opening B) a latanoprost solution container having a supply nozzle configured substantially statically relative to the housing or frame; and c) a dosing chamber having a valve comprising at least a first orifice and a second orifice. D) a mechanism configured to allow release of the latanoprost solution through the second orifice; and e) directing the released latanoprost solution out of the opening in a direction different from the supply nozzle. The present invention relates to an ophthalmic composition comprising a through passage configured to pass therethrough.

  One embodiment of the present invention is a method of using a composition for providing eye drops, the composition comprising a pharmaceutically effective amount of eye drops and a device for retaining the eye drops. The device includes: a) a housing or frame having an opening; b) an ophthalmic container having a supply nozzle configured substantially statically relative to the housing or frame; and c) at least a first. A dosing chamber having a valve comprising a second orifice and a second orifice; d) a mechanism configured to allow the release of ophthalmic solution through the second orifice; and e) the ophthalmic solution to be released. The present invention relates to a method of use comprising: a through passage configured to pass outwardly from the opening in a direction different from the supply nozzle.

In another embodiment, the invention relates to its use, wherein the ophthalmic solution comprises latanoprost.
In another embodiment, the invention relates to its use, wherein the eye drop comprises latanoprost and timolol maleate.

  Other features and advantages of the present invention will become more apparent upon reading the examples of embodiment given by way of non-limiting illustration only, with reference to the accompanying drawings.

  FIG. 1 shows a perspective view of one embodiment of a disposable repeat dose dispensing device according to the present invention. FIG. 1 shows the exterior of the device and includes a housing formed from two shells, a housing right 1 and a housing left 2, assembled by any suitable means. The liquid product released from the device via the air in the direction of the eye target, for example the cornea of the eye, is contained in a container 18 that is substantially fixed relative to the housing and support. The liquid product contained in the container 18 comes into fluid communication with the dosing chamber 7 by being aspirated after the dosing chamber 7 has been pressurized by retracting the plunger sealing 11. When the dosing chamber 7 is pressurized and filled with a liquid product, the plunger sealing 11 and plunger 12 are pushed out to release fluid onto the ocular target.

  In FIG. 1, it can be seen that actuation by normal force is performed in a direction that is substantially perpendicular to the direction of the discharged liquid product. The actuation mechanism takes the form of an actuator 4. Next, referring to FIG. 3, the housing right 1 and the housing left 2 are removed. The actuator 4 is configured to receive the moving element 5 and the actuator spring 17. The moving element 5 forms a moving component that drives the plunger 12 attached to the piston 10 toward or away from the target of the eye. The moving element 5 has a straight cam surface shape, and is operatively connected to the actuator 4 by an elongated portion 5c and arm portions 5b and 5a. The moving element 5 also has a cam surface 5d and operates to engage the piston 10 to retract and push the plunger 12. The moving element 5 also includes, in its center, the orifice 5e of FIG. 6 corresponding to a through passage, and when aligned with the dosing orifice 7d, the liquid product passes through the through passage and onto the eye target. Will be released. The particular structure of the actuator 4 that is operatively associated with the moving element 5 and the actuator spring 17 contributes to the accuracy of the dispensed fluid volume and the decontamination of the dosing chamber 7 with external contaminants.

  As shown in FIG. 6, the moving element 5 is a linear cam surface shaped component, which forms the moving element of the present invention. In the stationary state, the user can manually apply a vertical external force to the actuator 4. The force moves the moving element 5 in a plane perpendicular to the emission plane. The piston 10 extends horizontally beyond the dosing chamber 7 and the valve assembly 19. At a particular point in the movement of the moving element 5 along the plane, the cam surface 5d is operably linked to slide along the exposed outer surface of the piston 10 and push it. This operable linkage causes the piston assembly 10a to retract and simultaneously the plunger 12 to retract.

  When the plunger sealing 11 is retracted, pressure is generated and suction is performed, and the valve seal 9 causes liquid to flow from the container 18 into the dosing chamber 7. For stabilization, the plunger sealing 11 serves to seal and guide the plunger 12, and the combination of the piston 10, the plunger sealing 11, and the plunger 12 are combined to form the piston assembly 10a. A drive spring 15 housed in the plunger spring guide 13 is located behind the piston 10 and is provided to store the potential energy obtained by retraction of the piston assembly 10a. The cam surface 5d acts as a dosing mechanism and retracts the plunger 12 by a distance that is directly proportional to the push angle of the cam surface 5d. When the piston assembly 10a is retracted to a point that is directly proportional to the position 5f, the maximum angle of extrusion, the moving element 5 then continues to move along the plane. At a position 5g with an extrusion angle of about 0 °, the potential energy stored in the drive spring 15 is released, the plunger 12 is pushed out, and at the same time the orifice 5e in the form of a spray or flow towards the eye target. Via which fluid is discharged from the dosing chamber 7. The amount of liquid product that enters the dosing chamber 7 from the container 18, ie the dose, is defined by the tip angle of the moving element 5. When the liquid product is released from the device, the external force applied by the user on the actuator 4 can be removed and the actuator spring 17 serves to return the actuator 4 to its original position.

  The actuator spring 17 is accommodated in the cylinder 6 a of the support 6 and is in contact with the bottom surface of the actuator 4. The return valve spring 16 is disposed between the valve 8 and the valve spring guide 14. When in a stationary state, no force acts on the actuator 4. When the user applies a manual vertical force to the actuator 4, the actuator spring 17 and valve spring 16 are then compressed. In this active state, potential energy is stored by vertical compression of the actuator spring 17 and valve spring 16, and when it is released, the energy is released and the actuator 4 is stored again in its original resting state.

  As can be seen more clearly in the enlarged FIG. 6, the moving element 5 includes an orifice 5e for discharging the liquid product towards the eye target. The moving element 5 is configured to have a cam surface 5d that contacts the piston assembly 10 at a fixed point when moving in a plane perpendicular to the discharge plane. The valve assembly 19 consists of a valve 8 and a valve seal 9 in contact with the front surface 7a of the dosing chamber. Valve 8 and valve seal 9 operate in concert so that pressure is contained in dosing chamber 7.

  As shown in FIG. 3, the dosing chamber 7 is comprised of a substantially cylindrical barrel having a substantially constant cross-sectional area defining a concentric barrel axis and perpendicular to the barrel axis, the suction element 7f. And a plunger 12 inserted into the barrel, the plunger 12 being movable along its barrel axis. Furthermore, the orifice 5e has a substantially smaller cross-sectional area than the barrel.

  The front 7a of the dosing chamber includes two apertures: a dosing orifice 7d and a discharge orifice 7e. When active in the first position 5d, the moving element 5 serves to retract the plunger 12 in a direction opposite to the eye target to fill the dosing chamber. The pressure generated in the dosing chamber 7 fills the dosing orifice 7d. The moving element 5 then continues to move along its plane and at the second position 5g the liquid product in the dosing orifice 7d moves to the discharge orifice 7e and the liquid product passes through the orifice 5e to the ocular target. And is discharged through the eyepiece orifice 3b. The discharge orifice 7e is substantially narrower than the eyepiece orifice 3b or the orifice 5e, and the eyepiece orifice 3b is substantially wider than the orifice 5e and the discharge orifice 7e.

  Housing Right 1 and Housing Left 2 are each as polycarbonate (PC) Lexan® manufactured by General Electric Company, commercially available from Modern Plastics, located in Bridgeport, Connecticut, USA Bisphenol A, also known as hard plastic material such as acrylonitrile butadiene styrene (ABS), or any suitable commercially available hard plastic material available to those skilled in the art.

  The actuator 4 is formed from a hard plastic material such as polycarbonate (PC) Lexan® or acrylonitrile butadiene styrene (ABS), or any suitable commercially available hard plastic material available to those skilled in the art.

  The moving element 5 is formed from a rigid plastic material such as polycarbonate (PC) Lexan® or acrylonitrile butadiene styrene (ABS), or any suitable commercially available rigid plastic material available to those skilled in the art.

  The dosing chamber 7 is formed from a hard plastic material such as polycarbonate (PC) Lexan® or acrylonitrile butadiene styrene (ABS), or any suitable commercially available hard plastic material available to those skilled in the art.

  The container 18 is connected to the dosing chamber 7 by a supply nozzle 18a. The connection can be achieved by a lock and groove mechanism. Container 18 is formed from a plastic material, such as high density polyethylene (HDPE), or polypropylene (PP), commercially available from Equistar, Houston, Texas, USA, or any suitable commercially available plastic material available to those skilled in the art. Is done.

  The suction element 7f substantially has a cylindrical shape such as a spike, and is made of a metal such as steel, or polycarbonate (PC) Lexan (registered trademark) or acrylonitrile butadiene styrene (ABS), (PE). , (HDPE), or any suitable commercially available hard plastic material available to those skilled in the art. The suction element 7f also has a fixing means such as a jaw or a knob that enables the container 18 to be fixed.

  Piston 10 is attached to device support 6 and chamber 7 and is a rigid plastic material such as Celanex® polybutylene terephthalate copolymer (PBT) commercially available from Ticona North America, located in Florence, Kentucky, USA. Or any suitable commercially available rigid plastic material available to those skilled in the art.

  The plunger 12 is formed from a hard plastic such as high density polyethylene (HDPE), linear low density polyethylene (LLDPE), or polypropylene (PP), or any suitable commercially available hard plastic material available to those skilled in the art. The Optionally, the plunger can be formed from the same material as the container 18. Plunger 12 constitutes one embodiment of the present invention that allows the dispensing device to achieve the goal of accuracy and sterility, but other types of plungers may be used without departing from the scope of the present invention. You can also.

  Plunger sealing 11 is a flexible plastic material such as Huntsman® polyethylene, or Huntsman® polypropylene (PP), commercially available from Huntsman®, Woodland, Texas, USA, or a person skilled in the art. Formed from any suitable flexible plastic material available on the market.

  The valve 8 is formed from a hard plastic material such as Celanex® polybutylene terephthalate copolymer (PBT), or any suitable commercially available hard plastic material available to those skilled in the art.

  The valve seal 9 may be a commercially available DanFlex® available to those skilled in the art, or a soft elastic body such as Santoprene® TPE commercially available from Advanced Elastomer Systems, Inc., located in Akron, Ohio, USA Formed from any suitable commercially available soft thermoplastic elastomer.

  Both the plunger spring guide 13 and the valve spring guide 14 are formed from a rigid plastic material such as (HDPE) or (PP), or any suitable commercially available rigid plastic material available to those skilled in the art. .

  Actuator spring 17, valve spring 16, (valve spring right 16b and valve spring left 16a) and drive spring 15 are each formed from steel, such as commercially available stainless steel available to those skilled in the art.

  The eyepiece assembly 3 is accommodated in both the housing right 1 and the housing left 2. Referring to FIG. 1, the eyepiece assembly 3 does not move, but can optionally be moved, for example, making the device retractable for easy storage. An eyepiece assembly 3 is provided to guide the administration of the ophthalmic solution product to the eye. The outer ring 3a of the eyepiece is formed from a soft flexible material such as Santoprene® TPE, VersaFlex® or commercially available silicone available to those skilled in the art to provide comfort. The eyepiece 3 is formed from a hard plastic material such as polycarbonate (PC) Lexan® or acrylonitrile butadiene styrene (ABS), or any suitable commercially available hard plastic material available to those skilled in the art.

  Support 6 is operatively connected to actuator 4, moving element 5, dosing chamber 7, piston assembly 10 a, valve assembly 19, and valve spring guide 14. The support 6 is formed from a hard plastic material such as Celanex® polybutylene terephthalate copolymer (PBT), or any suitable commercially available hard plastic material available to those skilled in the art. The support 6 is itself contained within both the housing right 1 and housing left 2 of the device.

  Liquid products contemplated by the present invention include, for example, Xalatan®, Xalacom®, or any latanoprost-containing solution, timolol formulation, dry eye solution, topical eye solution, Visine®, etc. Or topical antibiotics, or any ophthalmic solution such as any product containing an active ingredient such as tetrahydrozoline HCL or zinc sulfate, or any suitable ophthalmic solution known to those skilled in the art.

The device can optionally include a medication counter, a switch for displaying the date and time, and the like.
A suitable kit should include ophthalmic solution, eg, Xalatan®, device, and instructions for use.

  All components of the device work in concert to facilitate metering and subsequent administration of the ophthalmic drug. In addition, all of the components of the device are formed from moderate amounts of cost-effective components, thus meeting the disposable nature of the device.

Filling Position From the filling position shown in FIG. 4, by applying a normal force against the actuator 4, the cam surface 5d moves the piston assembly 10a in the opposite direction of the eye target, thereby retracting the plunger 12, Thereafter, the valve spring 16 is compressed. In this position, the container 18 is in fluid communication with the dosing chamber 7 via the suction element 7f so that the dosing chamber 7 can be filled with a liquid product. By applying a normal force to the actuator 4, at position 5f the chamber 7 is filled with a fully metered liquid product.

Release Position By subsequently applying a normal force to the actuator 4, the moving element 5 releases the piston assembly 10a as shown in FIG. The liquid product then fills the discharge orifice 7e and the orifice 5e is aligned therewith. The liquid to be discharged is discharged through both the discharge orifice 7e and the orifice 5e by the return action of the drive spring 15. By releasing the vertical external force on the actuator 4, the moving element 5 pivots upward just inside the piston 10 and in the opposite direction to the normal force by the return action of the button spring 17 and valve spring 16. Slide upward.

  It will be appreciated that the device described above is configured for repeated dosing applications, i.e., applications in which dosages are repeatedly aspirated and repeatedly released from a supply. It will also be apparent that the device is also illustrated with functions suitable for ophthalmic treatment applications. Exemplary parameters for this application are set forth below, but the invention should not be considered limited to this application or any such exemplary parameters. A single dosage for administration to the eye is less than 100 μL, suitably less than 50 μL, and suitably less than 30 μL. In general, the volume at the standby position is at least 1 μL, suitably at least 2 μL, and suitably at least 3 μL. Suitably, the container 18 has a capacity capable of administering these multiple dosages.

  A suitable distance from the exit of the device to the eye is about 24 mm. A suitable jet time is about 40 to 60 milliseconds. Appropriate velocity for drop flow or ejected jet has sufficient momentum to traverse the air gap between the device opening and the target without the aid of gravity, hindered by blinking It is a balance between moving at a high enough speed that is not done and not inflicting adverse, harmful impacts on the eye. The ideal speed depends to some extent on the size of the drops used, but as a general rule, a suitable drug will move through the air due to its own momentum, considering a reasonable distance between the opening and the target. Should be able to cross at least 1 cm, suitably at least 3 cm, very suitably at least 5 cm. Suitable low speed limits when leaving the opening of the device are 0.1 m / s, suitably 0.5 m / s and very suitably at least 10 m / s. In general, the upper speed limit is lower than 200 m / s, suitably lower than 100 m / s. The appropriate drop size defined as such should not be immediately decelerated and should be of sufficient size not to be easily redirected, eg not sucked, with a minimum diameter of 20 μm, Suitably having a thickness of 50 μm or more, and very suitably at least 100 μm or more. Usually the size is less than 200 μm and suitably less than 150 μm.

  The flow can take the form of a horizontal shower or a spray of atomized liquid droplets, but it is appropriate that the flow be narrow and sufficiently coherent, provided that such a flow is After a certain time and distance, it tends to break into individual droplets. The values given above are intended to relate to spherical droplets and, for multiple droplets, to a weight average of particle diameter. The agglomerated flow tends to break into droplets that are approximately twice the diameter of the flow. Thus, a suitable opening diameter for the dosing orifice is about half of the given drop diameter, or roughly between 10 and 1000 μm, suitably between 20 and 800 μm. The above considerations are sufficiently independent of liquid viscosity and are often applied to both liquid products and ointments. It is desirable that the entire dosage can be administered within a time shorter than the blink reflex time, ie, less than about 150 m / s, suitably less than 100 m / s, and very suitably less than 75 m / s. .

1 is a perspective view of a dispensing device according to the present invention with a housing attached. FIG. 1 is a front perspective view of a dispensing device according to the present invention with a housing attached. FIG. It is the disassembled perspective view of the apparatus shown in FIG. FIG. 5 is a cross-sectional view of the mechanism assembly in the rest position along line VV in FIG. 1. FIG. 2 is an exploded perspective view of the eyepiece shown in FIG. 1. FIG. 4 is a perspective view of the moving element shown in FIG. 3. FIG. 4 is a perspective view of the moving element shown in FIG. 3. FIG. 4 is a perspective view of the moving element shown in FIG. 3. FIG. 4 is a perspective view of the moving element shown in FIG. 3. It is a perspective view of the movement element in a discharge position. FIG. 6 is a front perspective view of a dosing chamber.

Explanation of symbols

1 Housing Right 2 Housing Left 3 Eyepiece Assembly 3a Outer Ring 3b Eyepiece Orifice 4 Actuator 5 Moving Element 5e Orifice 5d Cam Surface 6 Support 7 Dosing Chamber 7d Dosing Orifice 7e Discharge Orifice 7f Suction Element 8 Valve 9 Valve Seal 10 Piston 10a Piston Assembly 11 Plunger sealing 12 Plunger 13 Plunger spring guide 14 Valve spring guide 15 Drive spring 16 Valve spring 16a Valve spring left 16b Valve spring right 17 Actuator spring, button spring 18 Container 19 Valve assembly

Claims (15)

A device for administering a liquid product comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) at least a first orifice and a second. A dosing chamber having a valve, including an orifice; d) a mechanism configured to allow discharge of liquid through the second orifice; e) the discharged liquid; Through passages configured to pass out of the opening in different directions, and i) the mechanism is at least first in communication with the flow of the first orifice of the dosing chamber and the supply nozzle. 1 is movable with respect to the housing or the frame between the second orifice and the second position where the flow of the second orifice and the through passage communicates. And ii) the mechanism sucks liquid through the first orifice when the moving element is in the first position, and the moving element is in the second position. A device configured to allow the discharge of liquid through the second orifice.   The apparatus of claim 1, wherein the housing optionally comprises an eyepiece.   The apparatus of claim 1, comprising at least one actuator and adapted to operate the mechanism.   The apparatus of claim 1, wherein the moving element is adapted to move in a substantially vertical direction.   The apparatus of claim 1, wherein the dosing chamber comprises a substantially cylindrical barrel defining a concentric barrel axis.   The apparatus of claim 1, wherein the first orifice is adapted to connect with a suction element.   The mechanism is configured to sequentially perform suction of the liquid at the first position, movement of the moving element to the second position, and discharge of the liquid at the second position. Item 2. The apparatus according to Item 1.   The apparatus of claim 1, wherein the supply nozzle is disposed at a proximal end of the container. A method of operating a device for dispensing a liquid product, the device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) at least a first orifice and a second. A dosing chamber having a valve, including an orifice; d) a mechanism configured to allow discharge of liquid through the second orifice; e) the discharged liquid; A through passage configured to pass out of the opening in different directions; i) connecting the first orifice and the nozzle to allow flow; and ii) the flow Filling the dosing chamber with liquid through a first orifice; iii) with respect to an eye target, the second orifice from the dosing chamber Method comprising the steps of releasing the liquid through. A kit for operating a device for administering a liquid product, comprising a device for administering a liquid product, a liquid product, and instructions for use, said device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) at least a first orifice and a second. A dosing chamber having a valve, including an orifice; d) a mechanism configured to allow discharge of liquid through the second orifice; e) the discharged liquid; And a through passage configured to pass out of the opening in different directions. A method of treating an ophthalmic condition comprising a device for administering a liquid product, the device comprising:
a) a housing or frame having an opening; b) a liquid container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) at least a first orifice and a second. A dosing chamber having a valve, including an orifice; d) a mechanism configured to allow discharge of liquid through the second orifice; e) the discharged liquid; And a through passage configured to pass out of the opening in different directions, wherein the liquid product comprises a pharmaceutically effective amount of eye drops.   Use of a pharmaceutically effective amount of ophthalmic solution for the treatment of an ophthalmic condition, wherein the ophthalmic solution is provided to a patient via a device, the device comprising: a) a housing having an opening Or a frame; b) an ophthalmic solution container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) a valve comprising at least a first orifice and a second orifice. A dosing chamber having d) a mechanism configured to allow the discharge of eye drops through the second orifice; and e) the eye drops to be discharged in a direction different from the supply nozzle. And a through passage configured to pass out of the opening.   A kit for use in the treatment of an ophthalmic condition comprising ophthalmic solution, a device for administering said ophthalmic solution, and instructions for use, said device comprising: a) a housing having an opening Or a frame; b) an ophthalmic solution container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) a valve comprising at least a first orifice and a second orifice. A dosing chamber having d) a mechanism configured to allow the discharge of eye drops through the second orifice; and e) the eye drops to be discharged in a direction different from the supply nozzle. And a through passage configured to pass through the opening.   An ophthalmic composition comprising a pharmaceutically effective amount of latanoprost solution and a device for holding the latanoprost solution, the device comprising: a) a housing or frame having an opening; b) the housing or the A container for latanoprost solution having a supply nozzle configured substantially statically relative to the frame; c) a dosing chamber having a valve including at least a first orifice and a second orifice; d) the second E) a mechanism configured to allow discharge of the latanoprost solution through the orifice of e), and e) passing the discharged latanoprost solution out of the opening in a direction different from the supply nozzle. An ophthalmic component comprising a through passage configured as described above.   Use of a composition for providing eye drops, wherein the composition comprises a pharmaceutically effective amount of eye drops and a device for holding the eye drops, the apparatus comprising: a) a housing or frame having an opening; b) an ophthalmic container having a supply nozzle configured substantially statically relative to the housing or the frame; and c) at least a first orifice and a second. A dosing chamber having a valve comprising a plurality of orifices; d) a mechanism configured to allow the release of eye drops through the second orifice; and e) the dispensed eye drops. A usage comprising: a through-passage configured to pass out of the opening in a direction different from the nozzle.

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