DEVICE WITH CO-MOLDED CLOSURE, ONE-WAY VALVE AND VARIABLE-VOLUME STORAGE CHAMBER, AND RELATED METHOD

Abstract

A device includes a first part having a co-molded first support, valve cover and elastic actuator, and a second part having an injection molded second support, valve seat, and variable-volume storage chamber pre-form. The pre-form is blow molded into a flexible pouch defining the variable-volume storage chamber. The one-way valve includes a semi-annular, curvilinear, relatively rigid valve seat defining axially-extending, opposing first marginal portions, and an axially-extending first mid-portion angularly extending between the opposing first marginal portions. A flexible valve member is superimposed on the valve seat and defines axially-extending, opposing second marginal portions fixedly secured on or adjacent to respective first marginal portions of the valve seat, and an axially-extending second mid-portion angularly extending between the opposing first marginal portions and superimposed onto the first mid-portion of the valve seat. The flexible valve cover and valve seat form a normally closed axially and angularly extending valve seam therebetween.

Claims

1-43. (canceled).

44. A closure for a device, comprising: a base including a valve seat, and configured to sealingly engage an open end of a device to form a fluid tight seal therebetween and thereby close the device; and a support configured to sealingly engage the base to form a fluid tight seal therebetween, wherein the support is movable between a first position in which the support does not sealingly engage the base, and a second position in which the support sealingly engages the base; wherein the support includes a flexible or elastic valve member configured to engage the valve seat when the support is engaged with the base in the second position, and form a one-way valve defining a normally closed valve opening and a hermetic seal between the valve seat and the valve member; wherein the valve member is movable between the normally closed position and an open position with at least a portion of the valve member spaced away from the normally closed position to allow passage of fluid through the valve opening; wherein the one-way valve is configured (a) to define an interference fit between the valve member and the valve seat, and/or (b) so that segments of the valve member sequentially move between the normally closed and open positions when fluid moves through the valve opening to maintain the hermetic seal.

45. A closure as defined in claim 44, wherein the valve opening defines an axially-extending valve opening.

46. A closure as defined in claim 44, wherein the valve seat is a rigid valve seat.

47. A closure as defined in claim 44, further comprising (i) a pump configured to pump substance through the one-way valve or (ii) a compression chamber and a manually-engageable actuator coupled to the compression chamber, wherein the actuator is moveable between a rest position and an actuated position for pressurizing substance within the compression chamber and, in turn, dispensing fluid through the one-way valve.

48. A closure as defined in claim 44, further comprising a penetrable portion configured to receive therethrough a filling or injection member for sterile filling therethrough.

49. A closure as defined in claim 48, the penetrable portion containing a penetration aperture therein, and further comprising a liquid sealant overlying the penetration aperture formed in the penetrable portion for hermetically sealing the penetration aperture.

50. A closure as defined in claim 49, wherein the liquid sealant is a silicone.

51. A closure as defined in claim 49, wherein the liquid sealant is at least partially within a recess defined by the closure.

52. A device, comprising: a closure including a first support and a flexible valve cover; a second support including a valve seat and a storage chamber pre-form that has been blow molded into an expanded shape forming a flexible pouch defining a variable-volume storage chamber; and wherein the closure and the second support are assembled to one another such that the closure seals the variable-volume storage chamber with respect to ambient atmosphere and the valve cover is superimposed on the valve seat to form a normally closed valve seam therebetween.

53. A device as defined in claim 52, the closure further comprising a flexible actuator at least partially defining a compression chamber disposed between the flexible actuator and the second support and connectible in fluid communication between the variable-volume storage chamber and the valve seam.

54. A device as defined in claim 52, further comprising a penetrable portion in fluid communication with the chamber configured for penetration of a filling or injection member therethrough for filling the chamber.

55. A device as defined in claim 54, further comprising a penetration aperture formed in the penetrable portion and a liquid sealant overlying the penetration aperture for hermetically sealing the penetration aperture.

56. A device as recited in claim 55, wherein the liquid sealant was overlaid at ambient temperature.

57. A device as recited in claim 55, wherein the liquid sealant is a silicone.

58. A device as recited in claim 55, wherein the liquid sealant is overlaid at least partially within a recess defined by the device.

59. A device as defined in claim 52, further comprising a rigid hollow body within which the closure and the flexible pouch are at least partially received.

60. A device as defined in claim 52, wherein the first support includes a second valve cover and the second support includes a second valve seat, and the second valve cover is superimposed on the second valve seat, forming a filling valve defining a normally closed valve seam configured to allow filling of the variable volume storage chamber therethrough.

61. A device as defined in claim 52, wherein the storage chamber is collapsed and/or sterile.

62. A device as defined in claim 55, wherein the storage chamber is collapsed and/or sterile.

63. A device comprising: a first portion defining a relatively rigid outer body; a second portion defining a relatively flexible or collapsible pouch fixedly secured with the first portion, and a variable-volume storage chamber defined an interior of the pouch, wherein at least part of the variable-volume storage chamber is received within the outer body; and a closure engaging the first portion and hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere, the closure including a penetrable and resealable portion in fluid communication with the variable-volume storage chamber and penetrable by an injection member, a filling member and/or a needle for introducing substance into the variable-volume storage chamber, and a resulting penetration aperture in the penetrable and resealable portion is hermetically resealable to hermetically seal the variable-volume storage chamber with respect to ambient atmosphere.

64. A device as defined in claim 63, wherein the penetrable and resealable portion is hermetically resealable by applying a liquid sealant thereto and/or laser resealing.

65. A device as defined in claim 63, wherein the wherein the outer body defines an upper support for securing the second portion with the outer body.

66. A method comprising: aseptically filling a device including a first portion defining a relatively rigid outer body, a second portion defining a relatively flexible or collapsible pouch fixedly secured with the first portion, and a variable-volume storage chamber defined an interior of the pouch, wherein at least part of the variable-volume storage chamber is received within the outer body; and a closure engaging the first portion and hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere, the closure including a penetrable and resealable portion in fluid communication with the variable-volume storage chamber and penetrable by an injection member, a filling member and/or a needle for introducing substance into the variable-volume storage chamber, and a resulting penetration aperture in the penetrable and resealable portion is hermetically resealable to hermetically seal the chamber with respect to ambient atmosphere, the filling step including (a) penetrating the penetrable and resealable portion with an injection member, a filling member or a needle and, in turn, placing said injection member, filling member or needle in fluid communication with the variable-volume storage chamber; (b) introducing substance into the variable-volume storage chamber through said injection member, filling member or needle; (c) removing said injection member, filling member or needle from the penetrable and resealable portion; and (d) hermetically resealing a resulting penetration aperture in the penetrable and resealable portion and, in turn, hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere.

67. A method as defined in claim 66, wherein step (d) includes resealing the penetrable and resealable portion by applying a liquid sealant thereto or laser resealing.

68. A method as defined in claim 66, further including, prior to step (a), collapsing the pouch.

69. A method as defined in claim 68, wherein collapsing the pouch is by applying vacuum on the variable-volume storage chamber.

70. A method as defined in claim 68, wherein collapsing the pouch includes evacuating the pouch.

71. A method as defined in claim 68, wherein after collapsing the pouch the pouch contains little or substantially no air.

72. A method as defined in claim 66, further including substantially preventing formation of foam during step (b).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0033] FIG. 1 is a cross-sectional view of an assembled closure including a co-molded one-way valve, dome-spring actuator and support that is fixedly connected to an injection molded base including a valve seat and variable-volume storage chamber pre-form.

[0034] FIG. 2 illustrates sequential perspective views of the base of FIG. 1 including the injection molded variable-volume storage chamber pre-form, and showing the manner in which the injection molded pre-form is blow molded into a flexible pouch forming the variable-volume storage chamber.

[0035] FIG. 3 illustrates sequential perspective views of the base of FIG. 1 showing the manner in which the flexible pouch is collapsed by applying vacuum thereto prior to sterile filling.

[0036] FIG. 4 is a perspective view illustrating the assembled closure, including the integral one-way valve and dome-spring actuator, and collapsed flexible pouch assembly, prior to sterile filling.

[0037] FIG. 5 illustrates sequential perspective views of the sterilized closure and collapsed pouch assembly, and showing insertion of the sterilized assembly into a container housing prior to sterile filling.

[0038] FIG. 6 illustrates sequential perspective views of the assembled dispenser undergoing surface sterilization with a fluid sterilant, such as vaporized hydrogen peroxide (VHP), and evaporation thereof with heated filtered air prior to sterile filling.

[0039] FIG. 7 illustrates sequential perspective, cross-sectional views of the assembled dispenser undergoing sterile needle filling of the variable-volume storage chamber.

[0040] FIG. 8 is a perspective view illustrating resealing of the resultant penetration aperture with a liquid sealant, such as a room temperature vulcanizing silicone sealant, to hermetically reseal the closure and sterile product within the variable-volume storage chamber.

[0041] FIG. 9 illustrates perspective views of a family of dispensers embodying the present invention in different sizes.

[0042] FIG. 10 illustrates partial, cross-sectional views of the one-way valve of the devices of FIGS. 1-9.

DETAILED DESCRIPTION OF CURRENTLY PREFERRED

Embodiments of the Present Invention

[0043] In FIGS. 1-10, a device embodying the present invention is indicated generally by the reference numeral 10. The device 10 includes a first piece 12 that is secured to a second piece 14 to form a sealed, empty device. The first piece 12 defines an integral first support 16, actuator 18 and flexible one-way valve or valve cover 20. The components of the first piece 12 are co-molded, such as by injection molding the first support 16, and over molding the actuator 18 and valve cover 20 to the first support 16. The second piece 14 includes a second support 22, a valve seat or nozzle 24, and a variable-volume storage chamber pre-form 26. As described further below in connection with FIG. 2, the pre-form 26, but not the second support 22 and valve seat 24, is blow molded into a flexible pouch defining a variable-volume storage chamber 30.

[0044] The first piece 12 further defines a recess 32, which as described further below in connection with FIGS. 7 and 8, defines a needle penetrable region that is penetrable by a needle or other injection member to sterile or aseptically fill the variable-volume storage chamber 30. The recess 32 is adapted to receive a substantially metered amount of a liquid sealant, such as a silicone sealant, to hermetically seal the resulting needle penetration aperture and thereby hermetically seal the sterile filled substance within the variable-volume storage chamber 30.

[0045] As described further below, the flexible valve cover 20 and relatively rigid valve seat 24 form a one-way valve 34 defining an axially-elongated, normally closed interface or valve seam 36 therebetween. The first piece 12 and second piece 14 cooperate to define a compression chamber 38 that is connectible in fluid communication between the variable-volume storage chamber 30 and an inlet 40 to the normally closed valve seam 36 of the one-way valve 34. An annular check valve 42 is co-molded with the valve cover and actuator, and formed between the variable-volume storage chamber 30 and the compression chamber 38. As described further below, movement of the actuator 18 draws substantially metered amounts of the substance stored in the variable-volume storage chamber 30 through the check valve 42 and into the compression chamber 38 and, in turn, pressurizes the substance in the compression chamber above a valve opening pressure to dispense the substance through the normally closed valve seam 36 of the one-way valve 34 and out of the device. The first piece 12 further defines a resilient sealing member 44 co-molded with the valve cover, actuator and check valve, and extending about the periphery of the first piece. The second piece 14 defines a peripheral sealing surface 46 that engages the resilient sealing member 44 to form a compression seal therebetween to hermetically seal the interior of the device with respect to ambient atmosphere. The first support 16 defines on an interior surface thereof an annular groove 48 and an annular chamfer 50 formed adjacent to the annular groove. The second support 22 defines an annular flange 52 that is received within the annular recess 48 of the first support to fixedly secure the two supports together. The annular chamfer 50 facilitates movement of the second support 22 into the first support 16 and, in turn, snap fitting the peripheral flange 52 into the recess 48. Upon receiving the flange 52 into the recess 48, the sealing surface 46 compressively engages the sealing member 44 to form a dry, compression seal.

[0046] In the illustrated embodiment, the actuator 18 is substantially dome-shaped, and is formed of a resilient and/or elastomeric material. The dome-shaped actuator 18 defines a substantially dome-shaped spring that allows the actuator to be depressed inwardly to compress the compression chamber 38 and, in turn, dispense substantially metered volumes of substance through the one-way valve 34. A second substantially dome-shaped spring 54 is formed integral with the actuator, and is spaced axially and radially inwardly from the interior surface of the actuator 18 to define the compression chamber 38 therebetween. As can be seen, the spring 54 defines a curvilinear, substantially dome-shaped wall providing the spring with a substantial dome shape. The second piece 22 defines a boss 56 forming the inlet and outlet of the variable-volume storage chamber 30. The spring 54 defines an annular base 58 that is axially and radially spaced relative to the boss 56 to form an annular fluid-flow path therebetween. The second support 22 defines an annular recess 60 that receives therein the annular base 58 of the spring 54. The annular recess 60 defines an annular fluid flow path between the variable-volume storage chamber 30 and the one-way check valve 42.

[0047] In order to actuate the device 10, the actuator 18 is depressed inwardly to compress the substance within the compression chamber 38 above the valve opening pressure. As the actuator 18 is depressed inwardly, the annular base 58 of the spring 54 is moved axially inwardly, and radially outwardly within the annular recess 60 of the second support 22. This forces the resilient annular check valve 42 radially outwardly against the annular sealing surface of the second support 22 to thereby maintain the check valve in the closed or sealed position, and in turn allow pressurization of the substance within the compression chamber above the valve opening pressure. The annular recess 60 also operates to stop further axial and radial movement of the base 58 with further inward movement of the actuator 18 to thereby progressively decrease the volume of the compression chamber 38 as the actuator 18 is further depressed. When the substance within the compression chamber 38 exceeds the valve opening pressure, the substance is forced through the inlet 40 and normally closed seam 36 of the one-way valve 34 and out of the device. Then, the actuator 18 is released which, in turn, allows the dome-spring of the actuator 18 and dome spring 54 to drive the actuator outwardly and into its ambient or rest position, as shown typically in FIG. 1. During movement from the depressed position to the rest or ambient position, the compression chamber 38 is expanded which, in turn, draws a substantially metered amount of substance from the variable-volume storage chamber 30, through the annular recess 60 and check valve 42, and into the compression chamber 38. The device 10 is then ready to dispense another metered amount of substance by repeating the foregoing steps. The actuator 18 may be manually engaged and depressed by a using the finger(s) of the same hand that is holding the device, or the device may be mounted within an apparatus known to those of ordinary skill in the pertinent art that includes an actuating device that engages the actuator 18 to depress the actuator.

[0048] As shown best in FIG. 10, the one way valve 34 comprises a semi-annular, relatively rigid valve seat 24 defining axially-extending, opposing first marginal portions 62, and an axially-extending first mid-portion 64 angularly extending between the opposing first marginal portions 62. The flexible valve member 20 is superimposed on the valve seat 24 and defines axially-extending, opposing second marginal portions 66 that are fixedly secured on or adjacent to the respective first marginal portions 62 of the valve seat 24. The valve cover 20 further defines an axially-extending second mid-portion 68 angularly extending between the opposing first marginal portions 66 and superimposed onto the first mid-portion 64 of the valve seat 24. In the illustrated embodiment, the mid-portions 64, 68 are curvilinear, and are substantially semi-circular. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the valve seat and valve cover may define any of numerous other curvilinear shapes, any of numerous other combinations of curvilinear and flat shapes, and/or a substantially flat or planar shape. The flexible valve cover 20 and valve seat 24 form the normally closed axially and angularly extending valve seam 36 therebetween. The valve seam 36 defines an inlet 70 at approximately one end thereof, and an outlet 72 axially spaced relative to the inlet at approximately another end thereof. As shown in FIG. 10, the valve cover 20 and valve seat 24 define a first degree of interference 74 therebetween at the inlet 70, and a second degree of interference 76 therebetween at the outlet 72 that is less than the first degree of interference 74. As shown in FIG. 10, the valve cover 20 is movable in response to fluid at the inlet 70 exceeding a valve opening pressure between (i) a normally closed position with the first and second mid-portions 64, 68 in contact with each other and defining the normally closed seam 36, and (ii) a second or open position with at least a portion of the valve cover 20 spaced away from the valve seat 24 to allow the fluid or other substance to pass through the seam 36 from the inlet 70 through the outlet 72. For example, as shown typically in FIG. 10, the pressurized fluid may cause axially spaced segments of the valve cover to sequentially move between the normally closed and open positions while the fluid moves from the inlet through the outlet of the valve.

[0049] In the illustrated embodiment, and as indicated by the broken lines in FIG. 10, the degree of interference between the valve cover 20 and valve seat 24 progressively decreases from the first degree of interference 74 to the second degree of interference 76, i.e., the deeper the broken line from the respective interface, the greater the interference. Also in the illustrated embodiment, the degree of interference substantially uniformly decreases from the first degree of interference 74 to the second degree of interference 76. In addition, as also indicated by the broken lines in FIG. 10, the degree of interference between the valve cover 20 and the valve seat 24 is higher at the marginal portions 66, 66 of the valve cover than at the mid-portion 68 of the valve cover. As can be seen, in the normally closed position, the valve cover 20 and valve seat 24 form a hermetic seal at the seam 36. In the illustrated embodiment, in the normally closed position, the hermetic seal substantially prevents the ingress of bacteria or germs in the direction from the outlet to the inlet.

[0050] In the illustrated embodiment, the flexible valve cover 20 is formed of an elastomeric material that exhibits substantially zero creep. In one currently preferred embodiment, the elastomeric material is a silicone. In another currently preferred embodiment, the elastomeric material includes an antimicrobial additive to further prevent any bacteria, germs or other microbial substances from entering the seam 36 of the valve or otherwise collecting on the dispensing tip of the valve. In another currently preferred embodiment, the elastomeric material is a silicone elastomer including a silver-based or other antimicrobial additive. Exemplary silicone elastomeric compounds for forming the valve cover and/or other features formed integral with the valve cover, including the actuator and sealing member, include any of numerous different liquid silicone rubbers, such as any of the liquid silicon rubbers sold by General Electric Company and/or Momentive Performance Materials under the LIM trademark, including LIM 8040, or other liquid silicone rubbers, silicones or silicone-based elastomers, such as the antimicrobial elastomers sold by General Electric Company and/or Momentive Performance Materials under the StatSil trademark.

[0051] As can be seen, in the currently preferred embodiments, the valve cover 20 defines a substantially uniform thickness substantially throughout the mid-portion 68 thereof and substantially throughout the marginal portions 66 thereof. The mid-portion 68 of the valve cover 20 is substantially in tension between the opposing marginal portions 66, 66 thereof. As shown in FIG. 10, the second support 22 defines a plurality of relatively sharp protuberances 78 that engage the undersides of the marginal portions 66, 66 of the valve cover 20 to fixedly secure the valve cover relative to the valve seat. As shown typically in FIG. 4, the first support 16 overlies the base and marginal portions of the valve cover to compress these portions of the valve cover against the valve seat and/or second support 22, and thereby fixedly secure the valve cover to the valve seat and form the one-way valve. As shown in FIG. 4, the first support 16 defines an arcuate shaped base clamping surface 80 and opposing marginal portion clamping surface 82 that extend axially along the marginal portions of the valve cover, and extend progressively radially outwardly from the mid-portion of the valve cover when moving in the direction from the inlet toward the outlet of the valve.

[0052] As shown typically in FIG. 2, the second piece 14 includes an injection molded pre-form 26, and the variable-volume storage chamber 30 is defined by a flexible pouch 28 blow molded from the injection molded pre-form 26. A significant advantage of this feature is that the variable-volume storage chamber, valve seat, and part of the compression chamber, can be formed in one part as the second piece. Yet another advantage is that the valve seat and second support can be injection molded and formed to relatively tight tolerances, whereas the pre-form can be blow molded into the flexible pouch forming the variable-volume storage chamber while nevertheless maintaining the relatively tight tolerances of the other features of the second piece requiring such tolerances. As indicated in FIG. 2, after the second piece 14 is injection molded, the pre-form 26 is preheated and then stretch blow molded to form the pouch 28 in a manner known to those of ordinary skill in the pertinent art. In the illustrated embodiment, the second piece 14 and thus the pre-form 26 is made of PET or PP (polypropylene). However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these components may be made of any of numerous different materials, and may define any of numerous different layers of material(s), or combinations of different materials forming the different features of the second piece, that are currently known, or that later become known. For example, the second piece, or the pre-form thereof, may be defined by a multi-layered, or laminated material to provide the desired barrier properties and/or internal surfaces for contact with the product to be stored therein.

[0053] As shown in FIG. 3, after blow molding the pre-form into the pouch 28, the pouch is collapsed, such as by pulling a vacuum on the variable-volume storage chamber 30. Then, as shown in FIG. 4, the first piece 12, which defines a device closure, is assembled to the second piece 14 to hermetically seal the variable-volume storage chamber 30 and form the one-way valve 34. As indicated above, the first piece or closure 12 is assembled to the second piece 14 by snap fitting the two parts at the peripheral flange 52 and annular groove or recess 48. After assembly of the first and second pieces 12 and 14, respectively, the sealed empty device is sterilized. In the illustrated embodiment, the device is sterilized by subjecting it to irradiation, such as ebeam or gamma radiation. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, any of numerous different methods or apparatus for sterilizing the device and/or the internal surfaces and cavities thereof, that are currently known, or that later become known, equally may be employed.

[0054] As shown in FIG. 5, the device 10 further includes a relatively rigid, hollow body or housing 84. The flexible pouch 28 is received within the hollow body 84, and the first support 16 is fixedly secured to the body. The housing 84 includes a base 86, which in the illustrated embodiment is flared, to support the device on a surface, and an upper support 88 that is secured to the first support 16 of the closure to attach the housing to the closure. As shown in FIG. 1, the second support 22 defines a depending, substantially annular flange 90 and a substantially annular recess 92 extending radially between the annular flange and the chamfer 50 of the first support 16. As shown in FIG. 7, the upper support 88 of the housing defines an upwardly extending, substantially annular flange 94 that is received within the annular recess 92 to secure the housing to the assembled first and second supports 16 and 22, respectively. In the illustrated embodiment, the annular flange 94 is press fit within the annular recess 92; however, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the flange 94 or housing 84 can be secured to the closure or first and/or second supports in any of numerous different ways that are currently known, or that later become known.

[0055] As shown in FIG. 6, the sealed, empty, sterilized device is then readied for sterile or aseptic filling by sterilizing again the penetrable region of the device (e.g., in case such surfaces are contaminated during transport or assembly post sterilization of the device). First, a fluid sterilant, such as vaporized hydrogen peroxide, is applied to the penetrable surface of the recess 32 of the actuator 18 to re-sterilize such surface(s). Second, a heated filtered gas, such as air, is applied to the fluid-sterilant receiving surface(s) to further evaporate such sterilant and provide a dry, sterilized, penetrable surface.

[0056] As shown in FIG. 7, the sealed, empty sterile device is then sterile or aseptically filled by introducing an injection member, such as a needle 96, through the penetrable portion at the base of the recess 32, introducing a substance 98 through the injection member and into the variable-volume storage chamber 30, withdrawing the injection member from the penetrable portion, and resealing a resulting penetration aperture formed in the penetrable portion. One advantage of collapsing the pouch 28 prior to filling is that there is very little, and preferably substantially no air in the variable-volume storage chamber 30 prior to filling, thus preventing or substantially preventing the formation of foam during filling of a liquid substance 98 into the variable-volume chamber. This can be a significant advantage with respect to increasing filling speeds, particularly with liquid substances that have a tendency to foam during filling, such as with liquid foods and beverages, such as milks or milk-based products, and other liquid products. Accordingly, the device and method of the present invention can provide significantly increased filling speeds in comparison to the prior art.

[0057] In the illustrated embodiment, and as shown in FIG. 8, the resealing step includes applying a liquid sealant 100 to the resulting penetration aperture formed in the recess 32 and hermetically resealing the penetrable portion with the liquid sealant. In the illustrated embodiment, the liquid sealant is applied at approximately ambient temperature. In the currently preferred embodiment, the liquid sealant is a silicone. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the liquid sealant can take the form of any of numerous different sealants that are currently known, or that later become known. As can be seen, a resealing device 102 is mounted over the devices to be resealed after needle filling. The resealing device 102 includes a source of liquid sealant 100, or is coupled in fluid communication with a source of liquid sealant, and a pump 104 for pumping metered amounts of the liquid sealant onto the penetrated regions of the devices to hermetically reseal the penetration apertures, and thus hermetically seal the aseptically filled product within the variable-volume storage chamber 30. The pump 104 may take the form of a piston-type pump as shown, or may take the form of any of numerous other mechanisms for metering volumes or other measured amounts of liquid sealant onto the penetration apertures of the devices to seal the apertures, that are currently known, or that later become known, such as systems with pressurized liquid sealant and valves for releasing the pressurized sealant. The resealing device 102 may be fixedly mounted over a motorized conveyor for transporting the devices 10, or may be movable relative to the devices, to align a dispensing port 106 of the device with the penetration aperture(s). An overpressure of sterile filtered air of other gas may be supplied into a chamber or barrier enclosure containing the needle(s) and liquid resealing device(s) to further prevent contamination of devices during the needle filling and liquid resealing process. If desired, the system may include a plurality of needles mounted on a manifold that is driven vertically, or on which the needles are driven vertically, into and out of engagement with the penetrable portions of the devices, and a plurality of liquid resealing devices mounted adjacent to, or downstream of, the needles for liquid resealing the penetration apertures.

[0058] In an alternative embodiment, rather than sterile filling the device with a needle or other injection member, and resealing the resulting penetration aperture, the device may include a second filling valve formed integral and co-molded with the dispensing valve to allow sterile filling of the variable-volume storage chamber through the filling valve. In this alternative embodiment, the second support of the closure includes co-molded therewith a first integral flexible valve cover and a second integral flexible valve cover. The first support includes a first valve seat and a second valve seat. The first valve cover is superimposed on the first valve seat and forms a first dispensing valve defining a first axially-extending, normally closed dispensing valve seam, and the second valve cover is superimposed on the second valve seat and forms a second filling valve defining a second axially-extending, normally closed filling valve seam. The first support at least partially defines the compression chamber connectible in fluid communication between the variable-volume storage chamber and the inlet to the first dispensing valve seam, and the second support defines an actuator movable between first and second positions for pressurizing fluid within the compression chamber above the valve opening pressure and, in turn, dispensing the pressurized fluid through the dispensing valve. The dome-shaped or other flexible actuator is formed integral and co-molded with the first and second valve covers.

[0059] In the method of forming the device of this alternative embodiment, the step of molding the closure includes co-molding the second support with the first integral flexible valve cover and the second integral flexible valve cover. The step of injection molding the support includes injection molding the support with the first integral valve seat and the second integral valve seat. The step of assembling the closure to the support includes (i) superimposing the first valve cover on the first valve seat and forming the first dispensing valve defining the first axially-extending, normally closed valve seam, and (ii) superimposing the second valve cover on the second valve seat and forming the second filling valve defining the second axially-extending, normally closed valve seam. After the sterilizing step, a filling member, such as a hollow cannula coupled in fluid communication with a pump or pressurized source of product to be sterile filled, is placed in fluid communication with the normally closed valve seam of the second filling valve. Then, the substance is sterile filled through the filling member and into the second normally closed valve seam at a pressure at or above a valve opening pressure of the second normally closed valve seam and into the variable-volume storage chamber. After the variable-volume storage chamber is sterile filled with the substance, the filling member is withdrawn from the second valve. The sterile filled substance is maintained hermetically sealed within the variable-volume storage chamber throughout a shelf life and between multiple doses of substance from the variable-volume storage chamber through the first dispensing valve.

[0060] One advantage of the device and method of the present invention is that the device may be manufactured in essentially two parts forming a sealed, empty, sterile variable-volume storage chamber that is ready for aseptic filling by needle penetration and resealing by liquid sealant or by any of numerous other sterile filling methods or devices that are currently known, or that later become known. Yet another advantage is that the housing or outer body may be formed of a relatively inexpensive material, such as recycled plastic, cardboard, or other biodegradable materials, that after use may be automatically disassembled into (1) the collapsed plastic bag and closure that can be recycled, and (2) the outer bottle or body which can be biodegradable. Alternatively, the housing can be reusable such that the collapsed pouch and closure can be removed from the housing, and a fresh pouch and enclosure can be inserted into the housing as many times as desired.

[0061] A significant advantage of the currently preferred embodiments is that the following features are provided in only two parts: zero possible ingress in a multi-dose delivery system; a non-contamination valve; a sterile filling port; a metering dose pump; a collapsible pouch defining a sealed, variable-volume storage chamber; and a compression chamber in fluid communication between the variable-volume storage chamber and the non-contamination valve and forming part of the metering dose pump. Yet another advantage of the currently preferred embodiments is that they provide the possibility to stay with a two piece collapsible assembly or to add a more rigid container that is completely bio-degradable, re-usable and/or recyclable. A still further advantage is that the unique valve prevents any ingress of any germs, bacteria or other unwanted substances, and thus prevents contamination of the product stored within the interior of the device which, in turn, may significantly increase the stability of the product. A still further advantage is that there is no need to refrigerate the container or other device, even after multiple dose delivery, since the variable-volume storage chamber remains hermetically sealed and each dose is sterile from the first to the last. Another advantage of the currently preferred embodiments is that the package provides a unique means to reduce the carbon foot print of the packaging in comparison to prior art packages. For example, there is no need to re-heat the product after filling (such as with retort processing), and there is no need to refrigerate the product or container after dispensing or between dispensing multiple doses over extended periods of time. Yet another advantage of the currently preferred embodiments is that they can provide a high, and even unmatched, safety level assurance in a very price competitive package.

[0062] As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes may be made to the above-described and other embodiments of the present invention without departing from the scope of the invention. For example, the device may be sterile filled in any of numerous different ways, including by needle penetration and laser resealing, or valve-in filling. The actuator, one-way valve, housing and other components of the device may be formed of any of numerous different materials or combinations of materials, may take any of numerous different shapes and/or configurations, and may be manufactured in accordance with any of numerous different methods or techniques, that are currently known or that later become known. In addition, the devices may include few or more components or features than the embodiments described herein. Further, the variable-volume storage chamber may be formed of any of numerous different materials or configurations, in accordance with any of numerous different manufacturing techniques, that are currently known or that later become known. In addition, the term semi-annular is used herein to mean a portion of, or less than 360 of a surface, but does not require that the surface be circular or defined by a portion of a circle. Rather, the semi-annular surface may be curvilinear in part and/or substantially flat in part. Accordingly, this detailed description of currently preferred embodiments is to be taken in an illustrative as opposed to limiting sense.