Source: https://patents.google.com/patent/US9963288B2/en
Timestamp: 2019-04-19 18:42:39+00:00

Document:
This application is a continuation of U.S. application Ser. No. 12/984,482, entitled “Dispenser and Apparatus and Method for Filling a Dispenser,” filed Jan. 4, 2011, now U.S. Pat. No. 8,627,861, which is a continuation of U.S. application Ser. No. 12/025,362, entitled “Dispenser and Apparatus and Method for Filling a Dispenser,” filed Feb. 4, 2008, now U.S. Pat. No. 7,861,750, which is a continuation of U.S. application Ser. No. 11/349,873, entitled “Dispenser and Apparatus and Method for Filling a Dispenser,” filed Feb. 8, 2006, now U.S. Pat. No. 7,328,729, which is a continuation of U.S. application Ser. No. 10/843,902, filed May 12, 2004, entitled “Dispenser and Apparatus and Method for Filling a Dispenser,” now U.S. Pat. No. 6,997,219, which claims priority to similarly-titled U.S. Application No. 60/469,677, filed May 12, 2003; and to similarly-titled U.S. Application No. 60/471,592, filed May 19, 2003, and to U.S. Application No. 60/488,355, filed Jul. 17, 2003, titled “Piston-Type Dispenser with One-Way Valve for Storing and Dispensing Metered Amounts of Substances, and Pivoting Cover for Covering Dispensing Portion Thereof,” and to U.S. Application No. 60/539,814, filed Jan. 27, 2004, entitled “Piston-Type Dispenser with One-Way Valve for Storing and Dispensing Metered Amounts of Substances,” the disclosures of which are hereby expressly incorporated by reference as part of the present disclosure.
In one embodiment, a dispenser comprises a body; a variable-volume storage chamber formed within the body; and a filling valve coupled in fluid communication with the storage chamber. The filling valve defines (1) a normally closed, fluid-tight position hermetically sealing the storage chamber from the ambient atmosphere, and (2) an open position allowing the passage of fluid through the valve to withdraw fluid therethrough to evacuate the storage chamber and/or to introduce fluid therethrough to fill the storage chamber. A pump is coupled in fluid communication with the storage chamber for pumping fluid out of the storage chamber; and a dispensing valve is coupled in fluid communication with the pump and defines (1) a normally closed, fluid-tight position preventing the passage of fluid therethrough, and (2) an open position for dispensing pumped fluid therethrough.
In one embodiment, the filling valve includes a flexible valve member, and a valve seat engagable with the flexible valve member. The flexible valve member is movable into the closed position in engagement with the valve seat to form a fluid-tight seal therebetween, and is movable into the open position spaced away from the valve seat to form a valve opening for the passage of fluid therebetween. The filling valve also may include a spring that urges the valve member toward the closed position. In one embodiment, the spring is formed integral with the flexible valve member. Also in an embodiment, the spring is approximately dome-shaped and applies both radially directed and axially directed forces to the flexible valve member to urge the valve member toward the closed position. At least one flow aperture is formed through the spring and is coupled in fluid communication between an inlet to the filling valve and the storage chamber.
Also in an embodiment, the filling valve includes a first valve seat and a first sealing surface movable relative to the first valve seat between the closed and open positions. The first sealing surface is engagable with the first valve seat in the closed position to form a fluid-tight seal therebetween, and is spaced away from the first valve seat in the open position to form a valve opening for the passage of fluid therethrough.
Also in an embodiment, the filling valve includes a second sealing surface and a second valve seat formed between the storage chamber and the dispensing valve. The second sealing surface is movable between an open position spaced away from the second valve seat for allowing the flow of fluid therethrough, and a closed position engagable with the second valve seat and forming a fluid-tight seal therebetween. The filling valve may include a flexible valve member defining the first sealing surface on one side thereof and the second sealing surface on another side thereof.
Another embodiment is directed to an apparatus for sterile filling a dispenser. In one embodiment, the dispenser includes a fill tube coupled in fluid communication with the filling valve. The apparatus for sterile filling includes at least one probe or filling member connectable in fluid communication with the filling valve to open the valve and withdraw fluid from the dispenser through the filling valve to evacuate the dispenser, and/or to introduce fluid from the probe and into the storage chamber of the dispenser.
The sterile filling apparatus may further comprise a vacuum source that is connectable in fluid communication with the probe for drawing a vacuum through the probe and, in turn, through a dispenser coupled in fluid communication with the probe, or that is otherwise connectable in fluid communication with the interiors of the dispensers, such as through the dispensing valves. The sterile filling apparatus also comprises a fluid source coupled in fluid communication with at least one probe for introducing fluid therethrough and into the storage chamber of a dispenser coupled in fluid communication with the probe. The sterile filling apparatus may further comprise a laminar flow source for introducing a substantially laminar flow of fluid over the at least one probe and dispenser coupled in fluid communication therewith.
In another embodiment, the interior of the dispenser is evacuated by connecting a vacuum source in fluid communication with the interior of the dispenser through the dispensing valve. Then, after evacuating the dispenser, filling the variable-volume storage chamber through the filling valve.
Other advantages of the present invention will become more readily apparent in view of the following detailed description of embodiments and accompanying drawings.
In FIG. 1, a dispenser is indicated generally by the reference numeral 10. The dispenser 10 comprises a rigid vial or body 12, a flexible bladder 14 mounted within the rigid vial 12, and a variable-volume storage chamber 16 formed between the vial and bladder for receiving therein a fluid or other substance, such as a medicament. The dispenser 10 further comprises a dispensing nozzle 18 and a pump 20 coupled in fluid communication between the dispensing nozzle 18 and the storage chamber 16 for pumping metered doses of the fluid or other substance from the storage chamber 16 through the dispensing nozzle.
The dispensing nozzle 18 includes a relatively rigid valve seat 22 and a flexible valve cover 24 mounted over the valve seat and defining an axially elongated, annular seam 26 therebetween. As described further below, the pump 20 forces a metered dose of fluid or other substance at sufficient pressure to open the valve (the “valve opening pressure”) and force the fluid through the valve seam 26 and out of the dispenser. The valve cover 24 may form an interference fit with the valve seat 22 to thereby form a fluid-tight seal in the normally closed position and, in turn, maintain the fluid or other substance within the dispenser in a sterile and hermetically sealed condition. Further, as shown typically in FIG. 1, the valve cover 24 defines a substantially tapered cross-sectional shape moving in the axial direction from the interior toward the exterior of the valve. This configuration requires progressively less energy to open each respective annular portion of the valve when moving axially from the interior toward the exterior of the valve. As a result, once the base of the valve is opened, the pressure is sufficient to cause the respective axial segments of the valve cover 24 to progressively open and then close after passage of fluid therethrough when moving in the axial direction to dispense a metered dose. Also, in some embodiments, during dispensing of a metered dose, a substantially annular segment of the valve cover 24 substantially always engages the valve seat 22 to maintain the fluid-tight seal across the valve 20 and thereby prevent ingress through the valve of germs, bacteria or other unwanted substances into the storage chamber.
The valve cover 24 and the valve seat 22 may take any of numerous different shapes and/or configurations that are currently known, or that later become known, such as any of the shapes and/or configurations disclosed in the following co-pending patent applications that are assigned to the Assignee of the present invention and are hereby expressly incorporated by reference as part of the present disclosure: U.S. Provisional application Ser. No. 10/640,500, filed Aug. 13, 2003, entitled “Container and Valve Assembly for Storing and Dispensing Substances”; U.S. Provisional Application No. 60/528,429, filed Dec. 10, 2003, entitled “Valve Assembly and Tube Kit for Storing and Dispensing Substances”; and U.S. Provisional Application No. 60/539,602, filed Jan. 27, 2003, entitled “Tubular Container and One-Way Valve Assembly for Storing and Dispensing Substances”.
The slide 28 defines a reduced cross-sectional portion 40 that cooperates with the piston tip 34 to define the volume of the dosage chamber 38 and thus the dosage volume of the dispenser. The axial extent of the reduced portion 40 defines a compression zone within which the fluid or other substance is compressed by the piston and, in turn, forced through the dispensing nozzle 18. On the downward stroke of the piston 32, and prior to the piston tip 34 slidably engaging the reduced portion 40, fluid is permitted to flow both forwardly in front of the piston, and rearwardly back over the sides of the piston tip. Then, when the piston tip 34 slidably engages the reduced portion 40, a fluid-tight seal is formed therebetween, thus trapping a precise volume of fluid within the compression zone and forcing the precise volume of fluid through the valve. The valve seat 24 defines one or more apertures (not shown) extending between the dosage chamber and the seam 26 to allow the fluid to flow therethrough and out of the valve. The valve tip 34 may be made of an elastomeric material that is relatively soft in comparison to the slide 28 and reduced portion 40 thereof. For example, the valve tip 34 may be made of a polymeric material, such as the material sold under the trademark Kraton™, or a vulcanized rubber or other polymeric material. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these materials are only exemplary, however, and numerous other materials that are currently or later become known for performing the function of the valve tip equally may be used.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the construction of many aspects of the dispenser 10, including aspects of the vial, variable-volume storage chamber, pump and nozzle, may be the same as or similar to that described in any of co-pending U.S. patent application Ser. No. 10/001,745, filed Oct. 23, 2001, entitled “Fluid Dispenser Having A Rigid Vial And Flexible Inner Bladder”, similarly titled U.S. patent application Ser. No. 10/691,270, filed Oct. 21, 2003, U.S. Provisional Application No. 60/519,961, filed Nov. 14, 2003, entitled “Delivery Device And Method Of Delivery”, and U.S. Provisional Application No. 60/539,814, filed Jan. 27, 2004, entitled “Piston-Type Dispenser With One-Way Valve For Storing And Dispensing Metered Amounts Of Substances”, each of which is assigned to the Assignee of the present invention, and is hereby expressly incorporated by reference as part of the present disclosure. In addition, the dispenser 10 may be mounted within any of the cartridges and/or housings shown in U.S. Patent Application No. 60/420,334, filed Oct. 21, 2002, entitled “Dispenser”, and/or U.S. Patent Application No. 60/443,524, filed Jan. 28, 2003, entitled “Dispenser”, each of which is assigned to the Assignee of the present invention, and is hereby expressly incorporated by reference as part of the present disclosure.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the spring 60 of the filling valve 56 may take any of numerous different shapes and/or configurations, or may be formed of any of numerous different materials, that are currently, or later become known for performing the function of the spring as described herein. For example, the spring may define a shape other than a dome shape, or may not be formed integral with the bladder or the valve member. Also, the shape and/or material of construction of the spring may be selected to control the spring force applied to the valve member. One advantage of the substantially dome-shaped configuration, however, is that the dome shape imparts lateral (or radial) and axial forces to the flexible valve member 58 to facilitate maintaining a fluid-tight seal throughout the shelf-life and usage of the dispenser 10. The bladder 12 (including the integral valve member 58) may be made of an elastomeric material that is relatively soft in comparison to the vial 12 and valve seat 54. For example, the bladder 12 may be made of a polymeric material, such as the material sold under the trademark Kraton™, or a vulcanized rubber or other polymeric material. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these materials are only exemplary, and numerous other materials that are currently, or later become known for performing the functions of the bladder and/or valve member equally may be used.
As shown in FIG. 1, when the dispenser is empty, the bladder 14 is fully expanded into engagement with the interior surfaces of the vial 12 such that the variable volume storage chamber 16 is at substantially zero volume. As described in the above-mentioned co-pending patent application, the bladder 14 may be formed such that it naturally tends to flex outwardly and create a positive pressure gradient on the fluid or other substance in the storage chamber 16. Also, in this position, the valve member 58 of the filling valve 56 is in the normally closed position to maintain the interior of the dispenser hermetically sealed. In this condition, the empty dispenser may be sterilized prior to filling, such as by applying gamma, e-beam, or another type of radiation thereto. Then, the sealed, empty and sterilized dispenser may be transported to a sterile filling machine or other filling station without risk of contaminating the sterilized interior portions of the dispenser, as described further below.
In order to fill the dispenser 10 with a fluid or other substance from the fluid source 80, the tip 78 of the filling member is moved axially inwardly against the valve member 58 of the filling valve 56 to open the valve. As shown in the embodiment of FIG. 5D, the valve member 58 is moved axially inwardly until the second sealing surface 68 of the valve member sealingly engages the corresponding valve seat 70 to form a fluid-tight seal therebetween. Then, as also shown in FIG. 5D, fluid is introduced from the fluid source 80, through the open filling valve 56 and into the storage chamber 16. The base 62 of the bladder 14 defines one or more grooves 81 or like fluid passageways formed between the base of the bladder 14 and vial 12, and extending in fluid communication between the inlet aperture 64 of the filling valve and storage chamber 16. In the fully open position, the second sealing surface 68 and corresponding valve seat 70 prevent fluid from flowing into the piston, and thus prevent such fluid from flowing into the valve 18 during the filling process. As shown in FIGS. 5B and 5C, as the fluid is filled into the storage chamber 16, the bladder 14 collapses and the variable volume chamber 16 correspondingly expands. As shown in FIG. 5C, in the filled position, the bladder 14 is collapsed toward, or in contact with, the fill tube 50. Once the storage chamber is filled, the filling member 74 is moved out of the fill tube 50 and the spring 60 of the filling valve 56 closes the valve member 58 to hermetically seal the fluid or other substance within the dispenser. As shown in FIG. 6A, upon withdrawing the filling member 74 and closure of the filling valve 56, the fluid or other substance within the storage chamber 16 is drawn into the formerly evacuated space of the piston conduit 36. As a result, the pump 20 will require at most minimal priming prior to dispensing the first dose of fluid or other substance therefrom.
In sum, and as shown typically in FIGS. 7A through 7D, the sealed, empty, sterilized dispensers 10 are introduced into the filling machine. Alternatively, if desired, the sealed, empty dispensers may be sterilized within the filling machine, such as by applying gamma and/or e-beam radiation thereto in a first stage of the sterile filling machine. As shown in FIG. 7B, the dispensers are first evacuated in a vacuum station. Then, as shown in FIG. 7C, the sealed, evacuated dispensers are filled in a filling station (both the vacuum and filling stations may include laminar flow to maintain aseptic conditions, as described above). If deemed necessary or desirable, an e-beam or other radiation source may be used to sterilize the exposed surface of the valve member 58 to further ensure sterilization of this surface prior to engagement of the surface with the evacuating/filling member. For example, as described further below, the evacuating and/or filling stations may be located within an e-beam chamber. Alternatively, a laser or other radiation source may be employed to scan or otherwise subject the exposed surface of the valve member 58 to radiation prior to passage through the evacuation and/or filling stations to further ensure the sterility of such surfaces. As shown in FIG. 7D, the Intact™ filled, sterilized, and hermetically sealed dispensers are discharged from the sterile filling machine and ready for usage.
With reference to FIG. 7E, in one embodiment, the dispensers are filled in a sterile filling assembly including a sterile enclosure 84 and one or more laminar flow sources 72 (not shown in FIG. 7E) for providing a substantially laminar flow of filtered/sterilized air over the dispensers during the filling and/or transporting thereof. In some embodiments, the sterile filling assembly is adapted to fill dispensers for containing medicaments, such as ophthalmic or other pharmaceutical or OTC products. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the sterile filling assembly equally may be used for filling any of numerous other substances, such as cosmetics and food products. The sterile filling assembly comprises an infeed unit 86 for holding the dispensers to be delivered into the enclosure 84 of the sterile filling assembly. In the illustrated embodiment, the infeed unit 86 is in the form of a rotary table that holds a plurality of dispensers, and delivers the dispensers at a predetermined rate into the sterile filling assembly. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the infeed unit may take the form of any of numerous devices that are currently known, or later become known for performing the functions of the infeed unit 86, such as any of numerous different types of vibratory feed drives, or “pick and place” robotic systems.
Prior to installing the dispensers on the infeed unit 86, the sealed empty dispensers may be sterilized, such as by exposing the containers to gamma radiation, in a manner known to those of ordinary skill in the pertinent art. In addition, the sealed, empty dispensers may be enclosed, sterilized, and transported to the sterile filling assembly in accordance with the teachings of U.S. Pat. No. 5,186,772, entitled “Method of Transferring Articles, Transfer Pocket And Enclosure”, and U.S. patent application Ser. No. 10/421,249, entitled “Transfer Port and Method for Transferring Sterile Items”, each of which is assigned to the assignee of the present invention and is hereby expressly incorporated by reference as part of the present disclosure.
A conveyor 90 is coupled to the infeed unit 86 for receiving the dispensers delivered by the infeed unit and for transporting the dispensers at a predetermined rate through the sterile filling assembly. In the illustrated embodiment, the conveyor 90 transports the dispensers in a single file relative to each other. The conveyor 90 may take the form of any of numerous different types of conveyers that are currently, or later become known, for performing the functions of the conveyor described herein. For example, the conveyor may take the form of a vibratory feed drive, or may take the form of an endless conveyor belt, or a plurality of star wheels, including, for example, a plurality of receptacles, such as cleats, for receiving or otherwise holding the dispensers at predetermined positions on the conveyor. The conveyor is drivingly connected to a motor or other suitable drive source (not shown), which is controlled by a computer or other control unit (not shown) to start, stop, control the speed, and otherwise coordinate operation of the conveyor with the other components of the sterile filling assembly.
In one embodiment, the radiation source 88 includes at least one e-beam source mounted within an e-beam housing 87 containing therein a filling station 77 including a bank or plurality of filling members 74. The e-beam source 88 may be any of numerous different types of e-beam sources that are currently, or later become known, for performing the function of the e-beam source described herein. E-beam radiation is a form of ionizing energy that is generally characterized by its low penetration and high dose rates. The electrons alter various chemical and molecular bonds upon contact with an exposed product, including the reproductive cells of microorganisms, and therefore e-beam radiation is particularly suitable for sterilizing dispensers or other containers for medicaments or other sterile substances. As indicated by the arrows in FIG. 7E, the e-beam source 88 produces an electron beam 89 that is formed by a concentrated, highly charged stream of electrons generated by the acceleration and conversion of electricity. The electron beam 89 may be focused onto the surfaces of the dispensers that will contact or be located in close proximity to the filling members 74 and onto the surfaces of the filling members 74. In addition, reflective surfaces (not shown) may be mounted adjacent to the conveyor in a manner known to those of ordinary skill in the pertinent art in order to reflect the e-beam, and/or the reflected and scattered electrons of the e-beam, onto the surfaces of interest of the dispensers and/or filling members to ensure adequate sterility of same. Alternatively, or in combination with such reflective surfaces, more than one e-beam source may be employed, wherein each e-beam source is focused onto a respective surface or surface portion of the dispensers and/or filling members to ensure sterilization of each surface area of interest.
The e-beam housing is constructed in a manner known to those of ordinary skill in the pertinent art to define an e-beam chamber and means for preventing leakage of the electrons out of the chamber in accordance with applicable safety standards. In one embodiment, the conveyor 90 defines an approximately U-shaped path within the e-beam chamber 87, wherein the first leg of the U defines an inlet section and the portion of the chamber onto which the e-beam is directed. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the e-beam may be directed throughout the chamber and/or to other portions of the chamber. The current, scan width, position and energy of the e-beam 89, the speed of the conveyor 90, and/or the orientation and position of any reflective surfaces, may be selected to achieve at least a 3 log reduction, and in some embodiments about a 6 log reduction in bio-burden testing on the requisite surfaces of the dispensers and/or filling members. In addition, as an added measure of caution, one or more of the foregoing variables also can be selected to achieve at least a 3 log reduction on the sides or other non-contact surfaces of the dispensers and non-contact surfaces of the filling members. These specific levels of sterility are only exemplary, however, and the sterility levels may be set as desired or otherwise required to validate a particular product under, for example, United States FDA or applicable European standards, such as the applicable Sterility Assurance Levels (“SAL”).
The sterile filling assembly 84 also may include means for visually inspecting the filling station 77. This means may take the form of a beta-barrier window (i.e., a window that blocks any e-beam radiation but permits visual inspection therethrough), and/or a CCD, video or other camera mounted within the housing for transmitting to an external monitor images of the filling station. As may be recognized by those skilled in the pertinent art based on the teachings herein, these particular devices are only exemplary, and any of numerous other devices that are currently known, or later become known, for performing the function of permitting visual inspection equally may be employed.
The filling station 77 is located on the opposite leg, or outlet side of the U-shaped conveyor path within the e-beam chamber. In one embodiment, the filling station 77 includes a plurality of filling members 74 mounted over the conveyor 90, wherein each filling member is drivingly mounted over the conveyor in the same manner as described above. The same filling member may be used to evacuate and to fill the dispensers, or the station may include separate banks of filling members for first evacuating and then filling the dispensers. In this configuration, the filling members used to evacuate the dispensers may be located on the inlet leg of the chamber, and the filling members used to fill the dispensers may be located on the outlet leg of the chamber. Accordingly, each filling member 74 is movable into and out of engagement with the valve members 58 of the dispensers received within the filling station to evacuate and/or fill the dispensers with a medicament or other substance to be contained therein, and to then withdraw the filling member upon filling the dispensers. In one embodiment, the filling station includes a bank of six filling members 74 mounted in line with each other and overlying the conveyor 90 to allow the simultaneous in-line evacuation and then filling of six dispensers. The filling members 74 may be mounted to a common drive unit (not shown), or each filling member may be individually actuatable into and out of engagement with the valve members of the dispensers. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the filling station may include any desired number of filling members, or may be mounted or driven in any of numerous different ways that are currently known, or later become known, for performing the functions of the filling station described herein. Similarly, the sterile filling assembly may include a plurality of filling stations mounted within the same e-beam chamber, or a plurality of e-beam and filling assemblies, in order to increase or otherwise adjust the overall throughput of the sterile filling assembly. In certain embodiments, the e-beam housing 87 defines a port or other removable passageway (not shown) to allow access to and/or repair and replacement of the filling station 77.
As described above, the e-beam and filling station is configured so that the filling members 74 are mounted within the e-beam chamber 87. As a result, the free electrons within the e-beam chamber will impinge upon the filling members. This, in combination with operation of the e-beam 89 which sterilizes the air throughout the e-beam chamber 87, functions to sterilize the filling members and/or maintain the sterility of the filling members throughout the filling process. Accordingly, since the containers or other dispensers are evacuated and filled within the e-beam chamber 87, there is virtually no risk that the dispensers will become contaminated between e-beam sterilization and filling. If desired, the air within the e-beam chamber may be ionized to promote multiplication of the free electrons and further enhance the sterility of the filling station 77. Furthermore, this feature obviates any need for an isolator, as found in many prior art sterile filling machines.
The e-beam source 88 and other applicable components of the e-beam chamber, conveyor systems, and filling assembly may be the same or similar to that disclosed in the following co-pending patent applications which are assigned to the Assignee of the present invention and hereby incorporated by reference as part of the present disclosure: U.S. application Ser. No. 10/600,525, entitled “Sterile Filling Machine Having Needle Filling Station Within E-Beam Chamber”; U.S. Provisional Application No. 60/518,267, filed Nov. 7, 2003, entitled “Needle Filling and Laser Sealing Station”; and U.S. Provisional Application No. 60/518,685, filed Nov. 10, 2003, entitled “Needle Filling and Laser Sealing Station”.
A significant advantage of the certain embodiments is that they enable true sterile filling and not only aseptic filling. Yet another advantage of certain embodiments is that the medicament or other substance is filled after subjecting the dispensers to gamma and direct e-beam radiation, thus preventing the radiation from degrading the medicament or other substance to be contained within the dispenser.
Yet another advantage of certain embodiments of the dispensers is that they may hold multiple doses of fluids or other substances, such as medicaments. A further advantage of various dispensers is that the fluids may be preservative free.
In FIG. 8, another dispenser is indicated generally by the reference numeral 110. The dispenser 110 is similar to the dispenser 10 described above with reference to FIGS. 1-7, and therefore like reference numeral preceded by the numeral 1 are used to indicate like elements. A primary difference of the dispenser 110 in comparison to the dispenser 10 is in the construction of the filling valve 156. As shown in FIG. 8, the free end of the fill tube 150 defines an axially-extending valve seat 154, and the base portion 162 of the flexible bladder 114 defines a flexible valve cover 158 that overlies the valve seat 154 to thereby define an annular, axially-extending seam 155 therebetween. In some embodiments, the flexible valve cover 158 and valve seat 154 form an interference fit to thereby maintain a fluid-tight seal when the valve is in the normally closed position. The fill tube 150 defines an annular recess 163 that fixedly receives therein a corresponding annular lobe formed by the base portion 162 of the bladder. The flexible valve cover 158 may define a substantially tapered, or progressively reduced wall thickness when moving axially in the direction of the inlet to the valve toward the interior of the dispenser. This configuration requires progressively less energy to open each respective annular portion of the valve when moving axially from the inlet to the valve to the interior of the dispenser. As a result, once the base of the valve is opened, the pressure is sufficient to cause the respective axial segments of the valve cover 158 to progressively open and then close after passage of fluid therethrough when moving in the axial direction. In certain embodiments, a substantially annular segment of the valve cover 158 substantially always engages the valve seat 154 to maintain the fluid-tight seal across the valve 156 and thereby prevent ingress through the valve of germs, bacteria or other substances. The tip of the fill tube 150 defines an annular flange 184 that is seated in a corresponding recess formed in the base of the vial body 112, and a tip 186 that is received within the piston 132 to define the piston fluid conduit 136 therebetween.
In FIGS. 10 and 11, another dispenser is indicated generally by the reference numeral 210. The dispenser 210 is similar to the dispenser 10 described above with reference to FIGS. 1-7, and therefore like reference numerals preceded by the numeral 2 are used to indicate like elements. A primary difference of the dispenser 210 in comparison to the dispenser 10 is in the construction of the filling valve 256 and flexible bladder 214.
As shown in FIGS. 10 and 11, the flexible bladder 214 defines in its expanded condition an exterior axially-extending cylindrical wall 215, an interior axially-extending cylindrical wall 217, and a curvilinear base portion 219 extending between the interior and exterior cylindrical walls. The free end of the fill tube 250 defines an axially-extending valve seat 254, and the base portion 262 of the inner wall 217 of the flexible bladder 214 defines a flexible valve cover 258 that overlies the valve seat 254 to thereby define an annular, axially-extending seam 255 therebetween. In some embodiments, the flexible valve cover 258 and valve seat 254 form an interference fit to thereby maintain a fluid-tight seal when the valve is in the normally closed position. The fill tube 250 defines an annular recess 263 that fixedly receives therein a corresponding annular lobe formed by the base portion 262 of the bladder. Annular flanges 265 extend outwardly from the fill tube 250 on either side of the annular recess 263, and are received within corresponding annular recesses formed in the base portion 262 of the inner wall of the bladder to fixedly secure the bladder and valve cover to the fill tube.
The flexible valve cover 258 may define a substantially tapered or progressively reduced wall thickness when moving axially in the direction of the inlet to the valve toward the interior of the dispenser. This configuration requires progressively less energy to open each respective annular portion of the valve when moving axially from the inlet to the valve to the interior of the dispenser. As a result, once the base of the valve 256 is opened, the pressure is sufficient to cause the respective axial segments of the valve cover 258 to progressively open and then close after passage of fluid therethrough when moving in the axial direction. In some embodiments a substantially annular segment of the valve cover 258 substantially always engages the valve seat 254 to maintain the fluid-tight seal across the valve 256 and thereby prevent ingress through the valve of germs, bacteria or other substances.
A significant advantage of the illustrated embodiments is that the dispensers may hold multiple doses of substances and store the substance remaining within the dispenser in a hermetically sealed, sterile condition between doses. Accordingly, in one embodiment, the substance shown is a non-preserved product. Because the variable-volume storage chamber maintains the substance in a sterile, hermetically sealed condition, from the first to the last dose, the use of preservatives may be avoided.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments without departing from the spirit of the invention as defined in the claims. For example, the components of the dispensers may be made of any of numerous different materials that are currently or later become known for performing the functions of such components. Similarly, the components of the dispensers may take any of numerous different shapes and/or configurations. Also, the dispensers may be used to dispense any of numerous different types of fluids or other substances for any of numerous different applications, including, for example, ophthalmic, nasal, dermatological, or other pharmaceutical or OTC applications. Further, the sterile filling machine used to fill the dispensers of the present invention may take any of numerous different configurations that are currently, or later become known for filling the dispensers in accordance with the teachings of the present invention. Such sterile filling machines may vary significantly from the filling machine disclosed herein. For example, the filling machines may have any of numerous different mechanisms for sterilizing, feeding, evacuating and/or filling the dispensers. Further, as indicated above, the same filling members or probes may be equipped to both evacuate the dispensers and fill the dispensers in the same station. Further, the filling valve need not be formed through the bladder, but may extend through the vial body or otherwise may be coupled in fluid communication with the storage chamber to evacuate and/or fill the storage chamber. Alternatively, the dispenser may include one valve for evacuating the interior of the dispenser and another valve for filling the storage chamber of the dispenser. Similarly, the pump and/or dispensing valve each may take a configuration that is different than that disclosed herein. In addition, the variable-volume storage chamber may not be formed by a flexible bladder, but rather may be formed by a piston slidably received within the vial body, as described, for example, in the above-mentioned co-pending patent application. Accordingly, this detailed description of embodiments is to be taken in an illustrative, as opposed to a limiting sense.
wherein the apparatus is configured to maintain sterility of a sterile substance entering the apparatus and passing through the valve in the open position to the chamber, thereby permitting aseptic passage of sterile substance into the chamber.
2. An apparatus as defined in claim 1, wherein the valve includes a spring that biases or urges the valve toward the closed position.
3. An apparatus as defined in claim 2, wherein the spring is formed integral with the valve.
4. An apparatus as defined in claim 3, wherein the spring is approximately dome-shaped.
5. An apparatus as defined in claim 1, wherein the spring applies both radially directed and axially directed forces to the valve to bias or urge the valve toward the closed position.
6. An apparatus as defined in claim 1, wherein at least one flow aperture is formed through the spring and is coupled in fluid communication between the valve and the chamber.
7. An apparatus as defined in claim 1, further comprising a spring coupled to the valve member and biasing the valve member toward the closed position.
8. An apparatus as defined in claim 7, wherein the spring is formed integral with the valve member.
9. An apparatus as defined in claim 8, wherein the spring defines an annular, curvilinear wall extending axially and radially from the valve member.
10. An apparatus as defined in claim 9, wherein the annular, curvilinear wall of the spring is approximately dome shaped.
11. An apparatus as defined in claim 1, wherein the valve further includes a valve seat engagable with the valve member in the closed position to form a fluid-tight seal therebetween.
12. An apparatus as defined in claim 1, wherein the valve includes a valve seat and a sealing surface movable relative to the valve seat between closed and open positions, wherein the sealing surface is engagable with the valve seat in the closed position to form a fluid-tight seal therebetween, and is spaced away from the valve seat in the open position to form a valve opening for the passage of substance therethrough.
13. An apparatus as defined in claim 1, further comprising a tube coupled in fluid communication with the valve.
14. An apparatus as defined in claim 1, further including a nozzle in fluid communication with the chamber.
15. An apparatus as defined in claim 1, further comprising a probe engagable with the valve to thereby open the valve and at least one of pass substance therethrough from the chamber, and pass substance therethrough to the chamber.
16. An apparatus as defined in claim 15, wherein the probe defines a passageway therethrough and an opening at an end thereof in fluid communication with the passageway configured for passing substance through the valve.
17. An apparatus as defined in claim 15, further comprising a substance source coupled in fluid communication with the probe for passing substance therethrough.
18. An apparatus as defined in claim 17, wherein the substance source comprises one or more of medicament, a cosmetic, food product, sterile substance or preservative free substance.
and maintaining the sterility of the sterile substance during the passing step.
20. A method as defined in claim 19, further comprising biasing the valve toward the closed position.
21. A method as defined in claim 20, wherein said biasing step includes biasing the valve toward the closed position with a spring having at least one flow aperture therethrough coupled in fluid communication between the valve and the chamber, and said step of passing substance through the valve includes passing substance through the at least one flow aperture.
22. A method as defined in claim 19, wherein the valve includes a valve seat and the valve member engagable with the valve seat to define the closed position and movable between the closed and the open position in which the valve member is spaced away from the valve seat, and said moving step includes moving the valve member from the closed position to the open position.
23. A method as defined in claim 19, further comprising passing substance out of the chamber through a nozzle of the device.
24. A method as defined in claim 19, further comprising engaging the valve with a probe, wherein said moving step includes moving the valve from the closed position to the open position with an end of the probe.
25. A method as defined in claim 24, further comprising introducing substance to the chamber from a substance source coupled in fluid communication with the probe.
wherein the apparatus is configured to maintain sterility of a sterile substance entering the apparatus and passing through the first valve in the open position to the chamber, thereby permitting aseptic passage of sterile substance into the chamber.
27. An apparatus as defined in claim 26, further including a spring that biases the first valve toward the closed position.
28. An apparatus as defined in claim 27, wherein the spring is integral with the first valve.
29. An apparatus as defined in claim 27, wherein the spring is approximately dome-shaped.
30. An apparatus as defined in claim 26, wherein the first valve includes a valve member movable between the closed and open positions and the valve member is biased toward the closed position.
31. An apparatus as defined in claim 30, wherein the first valve further includes a valve seat engageable with the valve member in the closed position to form a fluid-tight seal therebetween.
32. An apparatus as defined in claim 27, wherein the spring includes at least one flow aperture therethrough coupled in fluid communication between the first valve and the chamber.
33. An apparatus as defined in claim 26, wherein the first valve includes at least one valve seat and at least one sealing surface movable relative to the at least one valve seat between closed and open positions, wherein in the closed position the at least one sealing surface engages the at least one valve seat to form a fluid-tight seal therebetween, and in the open position the at least one sealing surface is spaced away from the at least one valve seat to form a valve opening for the passage of substance therethrough.
34. An apparatus as defined in claim 26, wherein the second valve includes a valve member movable between the closed and open positions and the valve member is biased toward the closed position.
35. An apparatus as defined in claim 26, further comprising a tube coupled in fluid communication with the first valve.
36. An apparatus as defined in claim 35, further comprising a substance source coupled in fluid communication with the tube for introducing substance therethrough and into the chamber.
37. An apparatus as defined in claim 36, wherein the substance source comprises one or more of medicament, a cosmetic, food product, sterile substance or preservative free substance.
maintaining sterility of the sterile substance entering the device during said passing steps.
39. A method as defined in claim 38, further including biasing one or more of the first valve or the second valve toward the respective closed position thereof.
40. A method as defined in claim 39, wherein said biasing step includes biasing the first valve toward the closed position with a spring having at least one flow aperture therethrough coupled in fluid communication between the first valve and the chamber, and said step of passing substance through the first valve includes passing substance through the at least one flow aperture.
41. A method as defined in claim 38, wherein the first valve includes a valve seat and a valve member engagable with the valve seat to define the closed position and movable between the closed and the open position in which the valve member is spaced away from the valve seat, and said step of moving the first valve from the closed position to the open position includes moving the valve member from the closed position to the open position.
42. A method as defined in claim 38, further comprising introducing substance to the device from a substance source coupled in fluid communication therewith.
a spring formed integral with the valve that biases or urges the valve toward the closed position, wherein the spring one or more of (i) is approximately dome-shaped or (ii) defines an annular, curvilinear wall extending axially and radially from the valve member.
a second valve coupleable in fluid communication with one or more of the first valve or the chamber and defining (1) a normally closed, fluid-tight position preventing the passage of substance therethrough, and (2) an open position for passing substance therethrough.
45. An apparatus as defined in claim 1, further comprising a probe or filling or evacuation member configured to engage the at least one exposed surface, move the valve member between the closed and open positions, and pass substance through the valve without contacting the at least one exposed surface.
46. A method as defined in claim 19, further comprising engaging a probe or filling or evacuation member with the at least one exposed surface, moving the valve member between the closed and open positions, and passing substance through the valve without contacting the at least one exposed surface.

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