Apparatus for storing and dispensing flowable compositions - Patent application

Abstract

1. A device for storing and dispensing a flowable dental composition, the device comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, and an applicator held within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the device including an inactive state and an active state.

Description

[Background technology]

[0001] In the field of dentistry and orthodontics, many manual operations must be performed in sequence and in a coordinated manner. Often, different amounts of dental compositions may be required for use with individual patients. Small amounts of liquid can be stored and dispensed in containers in the form of blister packs. Two recesses, spaced apart from each other for example, are formed in the thermoformed part of the pack, closed by a removable film. A small amount of liquid may be contained in the first recess, and a brush may be placed in the other recess. Examples of certain prior art packaging include:

[0002] WO 96 / 03326 discloses a disposable container having a cavity for storing a medicament and an applicator. Both cavities are protected from contamination by a peelable cover film. In one embodiment, the medicament is transferred into the cavity containing the applicator by pressing the cavity containing the medicament, in order to wet the applicator.

[0003] No. 3,835,834 discloses a treatment kit having two wells in a body, one containing a treatment substance and the other housing a swab, the body containing the treatment substance and the swab being protected from contamination by a sealing film.

[0004] European Patent Application No. 0895943 discloses a device for storing and dispensing flowable substances, which has a container made of two films connected to each other to form two chambers for receiving the substances and a pocket spaced from the chambers and used to remove a mixture of the two substances, the space between one chamber and the pocket having a transition area that can be selectively opened. To operate the device, first pressure is applied to one chamber, thereby transferring the substance located therein through the transition area to the second chamber. As a result, a positive pressure is built up in the second chamber, which causes one of the films forming the chamber to expand. To prevent the mixture from flowing back into the first chamber, the device must bend in the area between the two chambers.

[0005] US Patent No. 7,320,398 discloses a device specifically designed to store and dispense dental materials. The device comprises a container with first and second films forming at least one first chamber for containing a first substance and a recess spaced from the chamber and serving to remove the first substance. The spaced area between the recess and the first chamber comprises a passage area that can be selectively opened.

[0006] EP 1240087 discloses an apparatus for storing and dispensing free-flowing substances.

[0007] Examples of certain dental or orthodontic products available from the 3M Company, based in St. Paul, Minnesota, include 3M™ Adper™ Prompt™ L-Pop Adhesive, 3M™ Transbond™ L-Pop Adhesive, 3M™ Clinpro L-pop Blister, 3M™ Unitek™ Transbond™ and Transbond™ Plus Self Etching Primer, 3M™ L-Pop Prime and Bond Adhesive, 3M™ Adper™ L-Pop Easy Bond Self-Etch Adhesive, 3M™ L-Pop Single Bond Universal Adhesive, 3M™ L-Pop Scotchbond™ Universal and Universal™ Plus Adhesive Unit Doses. Summary of the Invention

[0008] SUMMARY The present disclosure relates to devices for storing and dispensing flowable compositions and methods of making same.

[0009] In one example, the disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber, a transition area, and a second chamber for containing the flowable dental composition, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the apparatus including an unactuated state and an actuated state, wherein in the unactuated state a substance is retained in the first chamber, and in the actuated state a portion of the second surface is substantially irreversibly deformed in response to pressure applied to the first chamber, thereby dispensing the substance through the transition area and into the second chamber.

[0010] In another example, the present disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, and an applicator held within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, wherein pressure applied to the first chamber can selectively open the transition area, thereby allowing fluid communication between the first chamber, the transition area, and the second chamber.

[0011] In another example, the disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a second chamber, and a transition area, and an applicator retained within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the apparatus including an unactuated state and an actuated state, wherein when in the unactuated state a first volume of the dental composition is retained in the first chamber and when in the actuated state a second volume of the dental composition in the first chamber is less than the first volume.

[0012] In yet another example, the present disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, an applicator held within the second chamber, and a light blocking portion for protecting the flowable dental composition from premature hardening.

[0013] In another example, the present disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, and an applicator held within the second chamber, wherein the second concave surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth convex surface matching the first concave surface.

[0014] In another example, the disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber, a transition area, and a second chamber for receiving the flowable dental composition, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the apparatus including an unactuated state and an actuated state, wherein in the unactuated state a substance is retained in the first chamber, and in the actuated state a portion of the second surface substantially irreversibly deforms in response to pressure applied to the first chamber, thereby dispensing the substance through the transition area and into the second chamber.

[0015] In yet another example, the present disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, and an applicator held within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, wherein pressure applied to the first chamber can selectively open the transition area, thereby allowing fluid communication between the first chamber, the transition area, and the second chamber.

[0016] In another example, the disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for receiving the flowable dental composition, a second chamber, and a transition area, and an applicator retained within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the apparatus including an unactuated state and an actuated state, wherein a first volume of the dental composition is retained in the first chamber when in the unactuated state and a second volume of the dental composition in the first chamber is less than the first volume when in the actuated state.

[0017] In another example, the disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, an applicator held within the second chamber, and a light blocking portion for protecting the flowable dental composition from premature hardening.

[0018] In another example, the present disclosure is directed to an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, and an applicator held within the second chamber, wherein the second concave surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth convex surface matching the first concave surface.

[0019] In yet another example, the disclosure is directed to a method of making a device for storing and dispensing a flowable dental or orthodontic composition, the method including providing a first layer, cold forming the first layer to partially form a first chamber and a second chamber, filling the first chamber with the flowable dental or orthodontic composition, providing a second layer, cold forming the second layer to partially form the first chamber and the second chamber, sealing the second layer to the first layer at a surface area thereof, leaving the first chamber and the second chamber open, forming a dispensing area, forming a selectively openable transition area between the first and second chambers and within the dispensing area, die cutting a desired shape of the device, and partially cutting the first and second layers with a cutout for a light blocking portion. [Brief description of the drawings]

[0020] [Figure 1] 1 is a schematic top view of an exemplary device for storing and dispensing a flowable dental composition. [Diagram 2] FIG. 2 is a schematic cross-sectional view of the device of FIG. 1 taken along line AA. [Figure 3A] 2 is a schematic cross-sectional view of the device of FIG. 1 taken along line AA, illustrating the step of dispensing a flowable composition from a first chamber to a second chamber of the device. [Figure 3B] 2 is a schematic cross-sectional view of the device of FIG. 1 taken along line AA, illustrating the step of dispensing a flowable composition from a first chamber to a second chamber of the device. [Figure 3C] 2 is a schematic cross-sectional view of the device of FIG. 1 taken along line AA, illustrating the step of dispensing a flowable composition from a first chamber to a second chamber of the device. [Figure 4] FIG. 2 is a schematic enlarged cross-sectional view of a first layer and a second layer of the device. [Diagram 5] 2 is a schematic enlarged cross-sectional view of a first layer and a second layer including an exemplary light blocking portion. [Figure 6] FIG. 6 is a schematic enlarged cross-sectional view of the device of FIG. 5. [Figure 7] 1A-1C are top views of an intermediate manufacturing step of the device 10 of the present invention. [Figure 8] 1 is a photograph showing the difference between a prior art device and a device of the present invention. [Figure 9A] 1 is a schematic top view of a further illustrative apparatus for storing and dispensing a flowable dental composition. [Figure 9B] 1 is a schematic top view of a further illustrative apparatus for storing and dispensing a flowable dental composition. [Figure 9C] 1 is a schematic top view of a further illustrative apparatus for storing and dispensing a flowable dental composition. [Figure 10] 1 is a schematic cross-sectional view of an apparatus for storing and dispensing a flowable dental composition. [Figure 11] 1 is a cross-sectional view of yet another illustrative device for storing and dispensing a flowable dental composition. [Figure 12A] 12 is a schematic cross-sectional view of the device of FIG. 11 illustrating the step of dispensing a flowable composition from a first chamber into a second chamber of the device. [Figure 12B] 12 is a schematic cross-sectional view of the device of FIG. 11 illustrating the step of dispensing a flowable composition from a first chamber into a second chamber of the device. [Figure 12C] 12 is a schematic cross-sectional view of the device of FIG. 11 illustrating the step of dispensing a flowable composition from a first chamber into a second chamber of the device. [Figure 12D] 12 is a schematic cross-sectional view of the device of FIG. 11 illustrating the step of dispensing a flowable composition from a first chamber into a second chamber of the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] 3M Company's popular L-Pop™ Adhesive line has offered a single-step, unit-dose adhesive or primer for both dental and orthodontic applications. Its proprietary packaging kept the contents separate in two compartments during storage until the dental professional was ready to mix the contents together to etch, prime, and bond in a single step.

[0022] The present invention focuses on the sustainable or environmental aspects of similar L-pop designs. In the new redesigned embodiment, the layer or laminate foil material is reduced by up to 50% compared to conventional L-pop products. For example, the present invention reduces the amount of laminate foil required to manufacture the device from 0.24g to 0.12g. FIG. 8 shows the size difference between the prior art L-pop design product by 3M, shown as the two items on the left, and the new design of the present invention, shown as the two embodiments on the right, which will be further described below. In addition, the manufacturing yield can be nearly doubled by only using close to the same amount of material. FIG. 7 helps to illustrate this aspect, which will also be described in more detail below. The geometry of the packaging of the present invention is also redesigned to reduce the possibility of wrinkles of the laminate or layers occurring in the liquid storage chamber, thereby maximizing the amount of flowable dental or orthodontic composition stored and then dispensed from the chamber or compartment. The absence of wrinkling of the layers also minimizes unused contents left in the chamber, as shown in Figure 3C. Finally, the present invention includes a unique light blocking feature that avoids premature aging (chemical degradation) or premature hardening of the stored dental substance.

[0023] An exemplary device 10 of the present invention is shown in Figures 1 and 2. In these figures, the device is in an inactivated state, e.g., this is how the device may be stored prior to use. Figures 3A-3C show the device 10 of the present invention in an activated state, e.g., the device 10 is shown in use.

[0024] The device 10 includes a first layer 12 and a second layer 14. Each layer 12, 14 is preferably a laminate foil made of both plastic layers and metal foil. The two layers 12, 14 are sealed together in a peelable manner to form a first chamber 16 and a second chamber 32. The first chamber is formed by a portion of the first layer 12 having a first concave surface 25 and a portion of the second layer 14 having a second concave surface 24 opposite the first concave surface 25. Each concave surface is from the perspective of a horizontal axis AA extending along the length of the device 10 or from the perspective of a composition 30 filled within the chamber. However, the description of the layers 12, 14 as "concave" or "convex" in shape does not exclude the possibility that the layers may have varying curvature characteristics, especially in the edge regions.

[0025] During the non-operating state of the device, a flowable composition 30, preferably a flowable dental or orthodontic composition 30, is contained within the first chamber 16. Examples of flowable dental compositions 30 may include adhesives, flowable composites, cements, liners, sealants, caries indicators, desensitizing agents, and caries-stopping solutions. Examples of flowable orthodontic compositions also include adhesives. The layers 12, 14 are formed to contain a volume of the composition 30 within the first chamber 16. In some embodiments, the composition 30 may be exposed to ambient light that enters the first chamber 16 via an optical path between layers 12 and 14. In some embodiments, the ingress of ambient light into the chamber 16 may occur when layers 12 and 14 further include a transparent or translucent sealing layer, and such sealing layer(s) may form a type of optical waveguide or pathway. In other words, the light propagates by total internal reflection within the optical waveguide until it reaches the chamber 16 and the composition 30 contained therein. Because of the possibility of premature hardening of the dental composition 30 while the device 10 is in storage, the device preferably includes a light blocking portion 17. The light blocking portion 17 can take many forms. One exemplary form is a cut-out portion 80, which is described in more detail below in connection with Figures 5 and 6.

[0026] The two layers 12, 14 also form a transition area that can be selectively opened by having peeling capabilities at a predetermined separation area formed between the two layers 12, 14 located between the first chamber 16 and the second chamber 32. The two layers 12, 14 also form a dispensing area 34 that holds the applicator 19. The applicator includes an applicator head 20 attached to the end of a handle 22. The handle 22 may include an optional gripping aid portion 33. The head 20 is held within the second chamber 32. The second chamber 32 is molded to have a relatively flat base and a convex cover portion that covers the head 20.

[0027] As shown in Figures 3A-3C, the device 10 is actuated by applying external pressure to the first chamber 16. A user may actuate the device from an unactuated state to an actuated state by applying external pressure with the user's index finger 50 and thumb 52. In this regard, pressure on the first chamber 16 actuates the device, thereby transferring the composition 30 located in the first chamber 16 into the second chamber 32 via the transition zone 18, which is selectively opened by fluid pressure, and the flow of the composition 30 between the first layer 12 and the second layer 14 in such zone. Thus, the selectively openable transition zone 18 represents, so to speak, a kind of predetermined separation point where the first chamber 16 opens and the composition 30 flows through the transition zone 18 into the second chamber 32. The transition zone 18 is designed to form a sealed closure both between the two chambers 16, 32 and to the zone 34 through which the composition 30 is dispensed in a storage or unactuated state.

[0028] The chambers 16, 32 are preferably rounded (such as circular or oval) in shape, but may be angular where appropriate (such as square, rectangular or triangular with rounded or pointed edges). Preferably, the first chamber 16 is hermetically sealed along its entire periphery. Activation of the device 10 can be visually observed by applying pressure to the first chamber 16.

[0029] The dispensing area 34 is preferably open towards one side, i.e. pocket-like, and is formed so that in the inactive or storage state a dispensing tool or applicator 19 can be introduced. The applicator 19 is preferably designed like a brush or swab. Alternatively, a pipette, a cotton swab, a sponge, a spatula or a spray head sealed into the dispensing area 34 can be used as application tool or device.

[0030] When the device 10 is in an activated state and the dental composition flows into the second chamber 32, the applicator 19 located in the dispensing area 34 is wetted and can then be used to apply the released dental composition 30. It is also possible to move the applicator 19 in the direction of the first chamber 16 to release the selectively openable transition area 18. This likewise results in the head 20 of the applicator 19 being wetted. If repeated application of the released substance is required, the applicator 19 can be reinserted into the pocket dispensing area 34. The dispensing area 34 or the applicator 19 is preferably designed such that a large portion of the handle 22 of the applicator 19 is not wetted when reinserted. This can occur, for example, by the formation of a channel shape in the dispensing area 34 and a corresponding formation of the applicator handle 22. The second layer 14 may also be configured in a dish or well shape at the dispensing area, and material is delivered to the dispensing area by squeezing the second chamber, as in a tube, to repeatedly wet the applicator 19 without wetting the handle 22.

[0031] The dispensing section 34 may also function as the application device itself, provided that the diameter of its outwardly facing opening is appropriately small, for example in the form of a cannula.

[0032] Preferably, the two layers 12, 14 are cold formed to provide the design as previously described. For example, cold forming may involve placing the layers 12, 14 containing metal foil into a die and squeezing the two layers together into a unit formed by the die while the metal in the die is at room temperature or below the recrystallization temperature of the metal foil to form the desired shape or configuration in the layers.

[0033] The layers 12, 14 are preferably connected to each other with surface-to-surface area contact, except in the areas forming the chambers 16, 32. Alternatively, the connection of the first layer 12 to the second layer 14 may be made, for example, by heat sealing, adhesive bonding, and / or ultrasonic welding with a sonotrode. The first layer 12 and the second layer 14 are adhered to each other in the transition area 18 and around the first chamber 16 and the second chamber 26 in the unactuated state. In this state, the transition area 18 has reduced adhesion between the first layer 12 and the second layer 14 compared to other areas around the first chamber 16 and the second chamber 32.

[0034] When the device 10 is in an inoperative state, the first cold-formed inner surface 24 of the first chamber 16 is concave, and the second cold-formed inner surface 25 of the first chamber 16 is concave. When the device 10 is in an operative state, the first cold-formed inner surface 24 of the first chamber 16 remains concave when viewed from the inside, and the second cold-formed surface 25 is deformed convex. Alternatively, both layers 12, 14 may be rounded or in some state between partially convex and partially concave, but always in near-complete surface contact with each other). In any case, this allows the flowable dental composition 30 to be dispensed from the first chamber 16 through the transition area 18. The matching surface areas of the surfaces 24 and 25 facilitate the complete evacuation of the composition 30 from the chamber 16 when the surface 25 is deformed convexly to conform and fit with the surface 24 that maintains its concave configuration. This is possible because both surfaces 24, 25 have been previously cold formed. An example of this phenomenon is shown in Figure 3C.

[0035] 4 and 5 show an exemplary device 10 having multiple layers 12, 14. Both the first layer 12 and the second layer 14 have three layers. The second layer 14 has a top layer 56 and the first layer 12 has a bottom layer 66. Both layers 56, 66 may be made of a transparent material. Examples of suitable materials for the transparent material of layers 56, 66 include polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polyamide (PA), polyvinyl chloride (PVC), ethylene vinyl alcohol (EVA), and PVF (polyvinyl fluoride). The second layer 14 includes a foil layer 58 adjacent to the top layer 56. The first layer 12 includes a foil layer 64. The middle foil layer 58, 64 is a metal foil, preferably aluminum. The first layer 12 also includes a film or sealing layer 62. Examples of suitable film or sealing layers 60 and 62 include polymeric films and / or adhesive films. In some embodiments, the polymer encapsulation layers 60 and 62 are transparent or translucent. In embodiments where one or both of the encapsulation layers 60 and 62 are transparent or translucent, the phenomenon of optical waveguide may occur between the foil layers 58, 64 when the layers 58 and 64 are at least partially reflective, such as is the case for aluminum.

[0036] The first layer also includes a film or sealing layer 60. The second layer 14 also includes a film or sealing layer 62. Examples of suitable film or sealing layers 60 and 62 include polymer layers and / or adhesive layers. In some embodiments, the polymer sealing layers 60 and 62 are transparent or translucent. In embodiments where one or both of the sealing layers 60 and 62 are transparent or translucent, the phenomenon of optical waveguide may occur between the foil layers 58 and 64 when the layers 58 and 64 are at least partially reflective, as is the case for metal foils such as aluminum. Examples of suitable sealing layers include polyethylene (PE), polypropylene (PP), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyamide (PA), polybutylene terephthalate (PBT), polyvinyl chloride (PVC), ethylene vinyl alcohol (EVA), and PVF (polyvinyl fluoride).

[0037] As mentioned above, the device preferably includes a light blocking portion 17. FIG. 5 shows an example of such a light blocking portion 17 (as shown, the light blocking portion 17 includes a cutout portion 80, or the cutout 80 may begin at the opposite side, layer 12). The cutout portion 80 acts as a blockage of potential light guides for any ambient or direct light outside the device 10. Light is directed through the film layers 60, 62 and internally reflects between the metal foil layer 58 and the metal foil layer 64. In the preferred embodiment shown in FIG. 1, the cutout portion 80 may be shaped to partially surround the first chamber 16. This light blocking portion 17 helps to prevent premature hardening or aging of dental compositions stored in the first chamber 16, especially those compositions that are light cured, e.g., cured by UV curing light. In addition, the layers 12, 14 may include layers with suitable diffuse impermeability. Other embodiments of light blocking portion 17 include carbon black material in layer 60 and / or layer 62. In some other embodiments, light blocking portion 17 may include coating aluminum layer(s) 58 and / or 64 with carbon black. In some embodiments, light blocking portion 17 may include doped layers 60 and 62 with carbon black or other additives to block internal reflections of light between foil layer 58 and foil layer 64.

[0038] FIG. 6 shows a schematic cross-sectional view of an exemplary light blocking portion 17 in use with a light source 202. The ambient light, as shown diagrammatically by the light source 202, is positioned relative to the device 10 such that the light emitted by the light source enters layers 12, 14 and is transmitted within the device by total internal reflection. The light does not enter through the top or bottom of the device 10 due to metal foils, such as aluminum, or otherwise opaque layers 58, 64, which reflect the light outwardly from the device. The ambient light emitted by the light source is represented by multiple light rays on the outside, and then by a single light ray 206, 207, 208 that is transmitted by total internal reflection. The light blocking portion 17, which in this case is a cutout portion 80, functions to stop the internal reflection propagation of the light ray 208. In addition, creating the cutout portion 80 may also cause deformations (not shown) in one or both of the layers 58 and 64, and such deformations, in the form of slight bends and wrinkles, may themselves provide the primary function of the light blocking portion 17. As a result, composition 30 is protected from such rays. As shown in Figure 1, cutout portion 80 surrounds first chamber 16 containing composition 30 to provide such protection.

[0039] The multi-layer structure of the first layer 12 and the second layer 14 can be achieved by lamination, calendaring, lamination of various layers with a single layer and, where appropriate, also by deposition of a metal, for example aluminum. Also, depending on the application area and the desired deformability, the layers 12, 14 are stretched or in an unstretched state before the operation of the device 10. The layers may be selected from plastic layers, metal foils and ceramic sheets. Suitable plastic layers are, for example, PE, PP, PTFE, PET, PA, PBT, PVC, EVA, PVF (polyvinyl fluoride). Suitable metal foils are, for example, aluminum (Al), tin (Sn), gold (Au), silver (Ag), iron (Fe) based such as steel, and lead (Pb). Suitable ceramic sheets are understood to mean layers having layers containing, for example, SiOx.

[0040] The volume of the first chamber 16 is usually in the range of 5 to 500 μl, preferably in the range of 10 to 250 μl. The volume of the second chamber 32 is preferably equal to or less than the volume of the first chamber, at least before operation of the device, and is in the range of 3 to 500 μl, preferably in the range of 5 to 250 μl. The first chamber 16 has a diameter, for example, in the range of 1 to 25 mm, preferably in the range of 5 to 15 mm. The second chamber 32 has a diameter, for example, in the range of 1 to 25 mm, preferably in the range of 5 to 15 mm.

[0041] The device 10 can be manufactured, for example, by the following method: a) providing a first layer 12, b) cold forming the first layer 12, thereby partially forming the first chamber 16 and the second chamber 32, c) filling the first chamber 16 with a flowable dental composition 30, d) providing a second layer 14, e) cold forming the second layer 14, thereby partially forming the first chamber 16 and the second chamber 32, f) sealing the second layer 14 to a significant extent in face area contact with the first layer 12, leaving the chambers 16, 32 unsealed and forming a selectively openable transition area 18 between the two chambers 16 and 32 and at the dispensing area 34, g) die cutting the outer contour or the desired shape of the device, and h) cutting the layer with a notch 80 for the light blocking portion 17. As for the sealing step, this may be done in two stages. The first stage seals the two layers 12, 14 together but leaves them peelable. The second stage seals the two layers 12, 14 together and makes them non-peelable in all areas except the transition area 18 and the open chambers 16, 32.

[0042] Figure 7 shows an intermediate step in the manufacturing process described above. In Figure 7, steps a) to f) have been completed. To achieve the goal of making more sustainable and environmentally friendly devices, the devices 10a to 10d are arranged as shown to optimise the use of materials. This arrangement helps to increase manufacturing yields.

[0043] Figure 8 is a side-by-side comparison photograph of a prior art L-Pop design, specifically 3M™ Scotchbond™ Universal L-Pop adhesive (left two images, front and back), compared to the device 10 of the present invention (right two images, front and back). Figure 8 is a photograph showing the difference between a prior art device (both prior art on the left) and a device of the present invention without the light blocking portion 17.

[0044] The device 10 is illustrated with various shapes for the first chamber 16. In this instance, the first chamber 16 is oval or circular, however, the first chamber 16 may be any desired shape.

[0045] Other exemplary devices 100 of the present invention are shown in Figures 9A-9C, 10 and 11. In these figures, the device 100 is in an inactivated state, e.g., this is how the device 100 may be stored prior to use. Figures 12A-12D show one of the devices 100e of the present invention in an activated state, e.g., the device 100e is shown in use.

[0046] Devices 100a, 100b, 100c, 100d, and 100e are very similar to device 10 shown in the previous figures, except that each device includes an optional flow barrier 36 in the dispensing area 34. The flow barrier 36 helps to prevent excess fluid dental composition 30 from accidentally splashing out of the dispensing area 34 during operation of device 100 or while brush head 20 is drawn from second chamber 32 by applicator 22. Instead of splashing, the flow barrier allows some of the excess composition 30 to be wiped away from saturated brush head 20, thus allowing the user to apply composition 30 in a more controlled manner and leave unwanted composition 30 in device 100. The flow barrier 36 can also improve the fit of brush head 20 and handle 22 in dispensing area 34 and second chamber 30 to help prevent applicator 19 from accidentally falling out of device 100.

[0047] As with the previously described device 10, the devices 100a-e include a first layer 12 and a second layer 14. Each layer 12, 14 is preferably a laminate foil made of both plastic layers and metal foil. The two layers 12, 14 are sealed together in a peelable manner to form a first chamber 16 and a second chamber 32. The first chamber is formed by a portion of the first layer 12 having a first concave surface 25 and a portion of the second layer 14 having a second concave surface 24 opposite the first concave surface 25. Each concave surface is from the perspective of a horizontal axis AA extending along the length of the device 10 or a composition 30 filled within the chamber. However, the description of the layers 12, 14 as "concave" or "convex" in shape does not exclude the possibility that the layers may have varying curvature characteristics, especially in the edge regions.

[0048] The layers 12, 14 are formed to accommodate the volume of the composition 30 within the first chamber 16. The two layers 12, 14 also form a selectively openable transition area 18 by having peel capability at a predetermined separation area formed between the two layers 12, 14, located between the first chamber 16 and the second chamber 32. The two layers 12, 14 also form a dispensing area 34. The dispensing area 34 is formed by a flow barrier 36, which is the area where the two layers 12, 14 are sealed to form a pocket between them for holding the shaft 32 of the applicator 22.

[0049] In the embodiments shown in Figures 9A-9C, the dispense zone 34 can take many forms. In Figure 9A, the dispense zone 34 in device 100a includes a first flow barrier 36a and a second flow barrier 36b. In this embodiment, the flow barriers 36a, 36b are in an opposing sinusoidal configuration. In Figure 9B, the dispense zone in device 100b has flow barriers 36c, 36d in a matched sinusoidal configuration. Figure 9C shows device 100c having a dispense zone 34 with flow barriers 36e, 36f in an opposing sinusoidal configuration that have been stretched to have fewer peaks and valleys.

[0050] Figure 10 shows yet another embodiment of a dispensing area 34. Rather than having a relatively flat base for the first film 12 as shown in the previous figures, in Figure 10 the dispensing area 34 includes a curved first film 12 and a curved second film 14. The curved flow barrier is aligned perpendicular to the axis of the applicator 19.

[0051] Figure 11 shows an alternative device 100 that is very similar to the previous device, however, the first film 12 of this device 100e is not completely flat as shown in Figure 3. Instead, the first film in device 100e is looser and concave, thus forming a more symmetric second chamber 30.

[0052] As shown in FIGS. 12A-12D, the device 100e is actuated by applying external pressure to the first chamber 16. A user may actuate the device from an unactuated state to an actuated state by applying external pressure with the user's index finger 50 and thumb 52. In this regard, pressure on the first chamber 16 actuates the device, thereby transferring the composition 30 located in the first chamber 16 into the second chamber 32 via the transition zone 18, which is selectively opened by fluid pressure, and the flow of the composition 30 between the first layer 12 and the second layer 14 in such zone. Thus, the selectively openable transition zone 18 represents, so to speak, a kind of predetermined separation point where the first chamber 16 opens and the composition 30 flows through the transition zone 18 into the second chamber 32. The transition zone 18 is designed to form a sealed closure both between the two chambers 16, 32 and to the zone 34 through which the composition 30 is dispensed in a storage or unactuated state.

[0053] The chambers 16, 32 are preferably rounded (such as circular or oval) in shape, but may be angular where appropriate (such as square, rectangular or triangular with rounded or pointed edges). Preferably, the first chamber 16 is hermetically sealed along its entire periphery. Activation of the device 10 can be visually observed by applying pressure to the first chamber 16.

[0054] The dispensing area 34 is preferably open towards one side, i.e. pocket-like, and is formed so that in the inactive or storage state a dispensing tool or applicator 19 can be introduced. The applicator 19 is preferably designed like a brush or swab. Alternatively, a pipette, a cotton swab, a sponge, a spatula or a spray head sealed into the dispensing area 34 can be used as application tool or device.

[0055] When the device 10 is in an activated state and the dental composition flows into the second chamber 32, the applicator 19 located in the dispensing area 34 is wetted and can then be used to apply the released dental composition 30. It is also possible to move the applicator 19 in the direction of the first chamber 16 to release the selectively openable transition area 18. This likewise results in the head 20 of the applicator 19 being wetted. If repeated application of the released substance is required, the applicator 19 can be reinserted into the pocket dispensing area 34. The dispensing area 34 or the applicator 19 is preferably designed such that a large portion of the handle 22 of the applicator 19 is not wetted when reinserted. This can occur, for example, by the formation of a channel shape in the dispensing area 34 and a corresponding formation of the applicator handle 22. The second layer 14 may also be configured in a dish or well shape at the dispensing area, and material is delivered to the dispensing area by squeezing the second chamber, as in a tube, to repeatedly wet the applicator 19 without wetting the handle 22.

[0056] Preferably, the two layers 12, 14 are cold formed to provide the design as previously described. For example, cold forming may involve placing the layers 12, 14 containing metal foil into a die and squeezing the two layers together into a unit formed by the die while the metal in the die is at room temperature or below the recrystallization temperature of the metal foil to form the desired shape or configuration in the layers.

[0057] When the device 10 is in an inoperative state, the first cold-formed inner surface 24 of the first chamber 16 is concave, and the second cold-formed inner surface 25 of the first chamber 16 is concave. Similarly, in an inoperative state, the inner surface 24 and the inner surface 25 of the second chamber 30 are both concave. When the device 10 is in an operative state, the first cold-formed inner surface 24 of the first chamber 16 remains concave when viewed from the inside, and the second cold-formed surface 25 is deformed to be convex. Alternatively, both layers 12, 14 may be rounded or in some state between partially convex and partially concave, but always in almost complete surface contact with each other. In any case, the flowable dental composition 30 is thereby dispensed from the first chamber 16 through the transition area 18. The matching surface areas of surfaces 24 and 25 facilitate the complete ejection of composition 30 from chamber 16 when surface 25 deforms convexly to conformally mate with surface 24, which maintains its concave configuration. This is possible because both surfaces 24, 25 have previously been cold formed. An example of this phenomenon is shown in FIG. 12C.

[0058] Subsequently, after the composition has been completely evacuated from the second chamber 30 through the transition area 34 and the applicator 19 has been withdrawn from the device 100e, the first cold-formed inner surface 24 of the second chamber 30 remains concave when viewed from the inside, while the second cold-formed surface 25 of the second chamber 30 is deformed convex. Alternatively, both layers 12, 14 may be rounded or in some state between partially convex and partially concave, but always in near-complete surface contact with each other. Having matching surface areas of surfaces 24 and 25 facilitates the complete evacuation of the composition 30 from the chamber 30 when surface 25 is deformed convexly to mate and fit with surface 24, which has maintained its concave configuration. This is possible because both surfaces 24, 25 have been previously cold-formed. An example of this phenomenon is shown in FIG. 12D. The cold-formed foil configuration further supports the sustainability aspect of the device of the present invention and helps reduce the overall manufacturing costs.

[0059] Although both dental and orthodontic compositions have been discussed above for use in the device 10, other flowable compositions (e.g., fragrances, lotions, lubricants, oils, paints, and permanent adhesives) are also contemplated.

[0060] Various modifications and alterations to the present disclosure will become apparent to those skilled in the art without departing from the scope and spirit of the present disclosure. It is to be understood that the present disclosure is not intended to be unduly limited by the exemplary embodiments, aspects, and examples described herein, and that such examples, aspects, and embodiments are presented only as examples within the scope of the present disclosure, which is intended to be limited only by the scope of the claims set forth herein as follows.

[0061] Exemplary Aspects Aspect 1 is a device for storing and dispensing a flowable dental composition, the device comprising a first layer and a second layer forming a first chamber, a transition area, and a second chamber for containing the flowable dental composition, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the device including an unactuated state and an actuated state, wherein in the unactuated state a substance is retained in the first chamber, and in the actuated state a portion of the second surface is substantially irreversibly deformed in response to pressure applied to the first chamber, thereby dispensing the substance through the transition area and into the second chamber.

[0062] Example 2 is the apparatus of Example 1, wherein the first concave surface and the second concave surface are cold formed.

[0063] A third embodiment is the device of any one of the first to third embodiments, further comprising a light-blocking portion.

[0064] Example 4 is the device of Example 3, wherein the first layer and the second layer comprise a first transparent layer, a second metal foil layer, and a third encapsulating layer.

[0065] Example 5 is the device of Example 4, wherein the light blocking portion comprises a cutout portion through the first layer and a portion of the second layer.

[0066] Example 6 is the device of Example 5, wherein one of the third encapsulating layers comprises carbon black.

[0067] Example 7 is the device of Examples 2-6, wherein when the device is in an unactuated state, the first cold-formed surface is concave and the second cold-formed surface is concave, and when the device is in an actuated state, the first cold-formed surface remains concave and the second cold-formed surface is deformed convex, thereby dispensing the flowable dental composition from the first chamber through the transition zone.

[0068] Example 8 is the apparatus of Examples 2-7, wherein a portion of the second cold-formed surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth surface matching the first concave surface.

[0069] Example 9 is the apparatus of Examples 2-8, wherein when the apparatus is in an actuated state, the first cold-formed surface remains concave without substantial wrinkling and the second cold-formed surface is transformed to a convex surface without substantial wrinkling.

[0070] Example 10 is the apparatus of Examples 1-9, wherein the first chamber is hermetically sealed along its entire perimeter.

[0071] Example 11 is the device of Examples 1-10, wherein the dispensing section is connected to the second chamber, the dispensing section holding the shaft of the applicator.

[0072] Example 12 is the device of Examples 1-11, wherein the first layer and the second layer are bonded to one another by heat fusion.

[0073] Example 13 is the device of Examples 1-12, wherein the first layer and the second layer are adhered to one another in the transition area and around the first and second chambers in the unactuated state.

[0074] Example 14 is the device of Example 13, wherein the transition area has reduced adhesion between the first layer and the second layer as compared to other areas around the first and second chambers.

[0075] Example 15 is the device of Examples 1-14, wherein a brush head of the applicator is within the second chamber.

[0076] Example 16 is the device of Examples 1-15, wherein during the activated state, a brush head of the applicator enters the transition zone.

[0077] Example 17 is the device of Examples 1-16, wherein the dental composition is a cement, an adhesive, or a fluoride coating.

[0078] Example 18 is a device for storing and dispensing a flowable dental composition, the device comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, and an applicator held within the second chamber, wherein the first chamber has a first concave surface formed in the first layer and a second concave surface formed in the second layer, and wherein pressure applied to the first chamber can selectively open the transition area, thereby allowing fluid communication between the first chamber, the transition area, and the second chamber.

[0079] Example 19 is the apparatus of Example 18, wherein the first concave surface and the second concave surface are cold formed.

[0080] Example 20 is the device of Examples 18-19, further comprising a light blocking portion.

[0081] Example 21 is the device of example 20, wherein the first layer and the second layer comprise a first transparent layer, a second metal foil layer, and a third encapsulating layer.

[0082] Example 22 is the device of Example 21, wherein the light blocking portion comprises a cutout portion through the first layer and a portion of the second layer.

[0083] Example 23 is the device of Example 22, wherein the third encapsulating layer comprises carbon black.

[0084] Example 24 is the device of Examples 19-23, wherein when the device is in an unactuated state, the first cold-formed surface is concave and the second cold-formed surface is concave, and when the device is in an actuated state, the first cold-formed surface remains concave and the second cold-formed surface is deformed convex, thereby dispensing the flowable dental composition from the first chamber through the transition zone.

[0085] Example 25 is the apparatus of Examples 19-24, wherein a portion of the second cold-formed surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth surface matching the first concave surface.

[0086] Example 26 is the device of Examples 19-25, wherein when the device is in an actuated state, the first cold-formed surface remains concave without substantial wrinkling and the second cold-formed surface is transformed to a convex surface without substantial wrinkling.

[0087] Example 27 is the apparatus of Examples 18-26, wherein the first chamber is hermetically sealed along the entire perimeter.

[0088] Example 28 is the device of Examples 18-27, wherein the dispensing section is connected to the second chamber, the dispensing section holding the shaft of the applicator.

[0089] Example 29 is the device of Examples 18-28, wherein the first layer and the second layer are adhered to one another by heat sealing.

[0090] Example 30 is the device of Examples 18-29, wherein the first layer and the second layer are adhered to one another in the transition area and around the first and second chambers in the unactuated state.

[0091] Example 31 is the device of Example 30, wherein the transition area has reduced adhesion between the first layer and the second layer compared to other areas around the first and second chambers.

[0092] Example 32 is the device of Examples 18-31, wherein the brush head of the applicator is within the second chamber.

[0093] Example 33 is the device of Examples 18-32, wherein during the activated state, the brush head of the applicator enters the transition zone.

[0094] Example 34 is the device of Examples 18-33, wherein the dental composition is a cement, an adhesive, or a fluoride coating.

[0095] Aspect 35 is a device for storing and dispensing a flowable dental composition, the device comprising a first layer and a second layer forming a first chamber for containing the flowable dental composition, a second chamber, and a transition area, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the device including an unactuated state and an actuated state, wherein when in the unactuated state a first volume of the dental composition is retained in the first chamber and when in the actuated state a second volume of the dental composition in the first chamber is less than the first volume.

[0096] Example 36 is the apparatus of Example 35, wherein the second volume is 10% smaller than the first volume of the dental composition in the chamber.

[0097] Example 37 is the apparatus of Examples 35-36, wherein the first concave surface and the second concave surface are cold formed.

[0098] Example 38 is the device of Examples 35-37, further comprising a light blocking portion.

[0099] Example 39 is the device of Example 38, wherein the first layer and the second layer comprise a first transparent layer, a second metal foil layer, and a third encapsulating layer.

[0100] Example 40 is the device of Example 39, wherein the light blocking portion comprises a cutout portion through the first layer and a portion of the second layer.

[0101] Example 41 is the device of Example 40, wherein one of the third encapsulating layers comprises carbon black.

[0102] Example 42 is the device of Examples 37-41, wherein when the device is in an unactuated state, the first cold-formed surface is concave and the second cold-formed surface is concave, and when the device is in an actuated state, the first cold-formed surface remains concave and the second cold-formed surface is deformed convex, thereby dispensing the flowable dental composition from the first chamber through the transition zone.

[0103] Example 43 is the apparatus of any of Examples 37-42, wherein a portion of the second cold-formed surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth surface matching the first concave surface.

[0104] Example 44 is the device of Examples 37-43, wherein when the device is in an actuated state, the first cold-formed surface remains concave without substantial wrinkling and the second cold-formed surface is transformed to a convex surface without substantial wrinkling.

[0105] Example 45 is the apparatus of Examples 35-44, wherein the first chamber is hermetically sealed along the entire perimeter.

[0106] Example 46 is the device of any of Examples 35-45, wherein the dispensing section is connected to the second chamber, the dispensing section holding the shaft of the applicator.

[0107] Example 47 is the device of Examples 35-46, wherein the first layer and the second layer are adhered to one another by heat sealing.

[0108] Example 48 is the device of any of Examples 35-47, wherein the first layer and second layer are adhered to one another in the transition area and around the first and second chambers in the unactuated state.

[0109] Example 49 is the device of Example 48, wherein the transition area has reduced adhesion between the first layer and the second layer compared to other areas around the first and second chambers.

[0110] Embodiment 50 is the device of embodiments 35-49, wherein the brush head of the applicator is within the second chamber.

[0111] Embodiment 51 is the device of embodiments 35-50, wherein during the activated state, the brush head of the applicator enters the transition zone.

[0112]

[0033] Example 52 is the device of Examples 35-51, wherein the dental composition is a cement, an adhesive, or a fluoride coating.

[0113] Example 53 is a device for storing and dispensing a flowable dental composition, the device comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, an applicator held within the second chamber, and a light blocking portion for protecting the flowable dental composition from premature hardening.

[0114] Example 54 is the device of Example 53, further comprising a light blocking portion.

[0115] Example 55 is the device of Example 54, wherein the first layer and the second layer comprise a first transparent layer, a second aluminum layer, and a third encapsulating layer.

[0116] Example 56 is the device of Example 55, wherein the light blocking portion comprises a cutout portion through the first layer and a portion of the second layer.

[0117] Example 57 is the device of example 56, wherein the third sealing layer comprises carbon black.

[0118] Example 58 is the device of any of Examples 53-57, wherein the first layer and the second layer comprise metals, which are fused together with high heat and function as the light blocking portion.

[0119] Example 59 is the apparatus of Examples 53-57, wherein the first chamber has a first concave surface and a second concave surface.

[0120] Example 60 is the apparatus of Examples 53-59, wherein the first concave surface and the second concave surface are cold formed.

[0121] Example 61 is the device of any of Examples 53-60, wherein the device includes an unactuated state and an actuated state, and when in the unactuated state, a substance is retained in the chamber, and when in the actuated state, a portion of the second convex surface is substantially irreversibly deformed in response to pressure applied to the first chamber, thereby dispensing the substance through the transition zone and into the second chamber.

[0122] Example 62 is the device of Examples 55-61, wherein when the device is in an unactuated state, the first convex surface remains concave and when the device is in an actuated state, the second cold-formed surface is transformed from concave to convex, thereby dispensing the flowable dental composition from the first chamber through the transition zone.

[0123] Example 63 is the device of any of Examples 55-62, wherein a portion of the second surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth surface that matches the first concave surface.

[0124] Example 64 is the device of any of Examples 55-63, wherein when the device is in an actuated state, the first surface remains concave without substantial wrinkles and the second surface is transformed into a convex surface without substantial wrinkles.

[0125] Example 65 is the device of Examples 55-64, wherein the first chamber is hermetically sealed along the entire perimeter.

[0126] Example 66 is the device of any of Examples 55-65, wherein the dispensing section is connected to the second chamber, and the dispensing section holds the shaft of the applicator.

[0127] Example 67 is the device of Examples 55-66, wherein the first layer and the second layer are adhered to one another by heat sealing.

[0128] Example 68 is the device of any of Examples 55-67, wherein the first layer and the second layer are adhered to one another in the transition area and around the first and second chambers in the unactuated state.

[0129] Example 69 is the device of Example 68, wherein the transition area has reduced adhesion between the first layer and the second layer compared to other areas around the first and second chambers.

[0130] Example 70 is the device of Examples 66-69, wherein the brush head of the applicator is within the second chamber.

[0131] Embodiment 71 is the device of embodiments 66-70, wherein during the activated state, the brush head of the applicator enters the transition zone.

[0132] Example 72 is the device of Examples 66-71, wherein the dental composition is a cement, an adhesive, or a fluoride coating.

[0133] Example 73 is an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, and an applicator held within the second chamber, wherein the second concave surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth convex surface matching the first concave surface.

[0134] Example 74 is the device of example 73, wherein the device includes an unactuated state and an actuated state, and when in the unactuated state, a substance is retained in the chamber, and when in the actuated state, a portion of the second concave surface substantially irreversibly deforms in response to pressure applied to the first chamber, thereby dispensing the substance through the transition zone and into the second chamber.

[0135] Example 75 is the apparatus of Examples 73-74, wherein the first concave surface and the second concave surface are cold formed.

[0136] Example 76 is the device of Examples 73-75, further comprising a light blocking portion.

[0137] Example 77 is the device of Example 76, wherein the first layer and the second layer comprise a first transparent layer, a second aluminum layer, and a third encapsulating layer.

[0138] Example 78 is the device of any of Examples 66-77, wherein the light blocking portion comprises a cutout portion through the first layer and a portion of the second layer.

[0139] Example 79 is the device of example 78, wherein one of the third sealing layers comprises carbon black.

[0140] Embodiment 80 is the device of embodiments 75-79, wherein when the device is in an unactuated state, the first cold-formed surface is concave and the second cold-formed surface is concave, and when the device is in an actuated state, the first cold-formed surface remains concave and the second cold-formed surface is deformed convex, thereby dispensing the flowable dental composition from the first chamber through the transition zone.

[0141] Example 81 is the apparatus of any of Examples 75-80, wherein a portion of the second cold-formed surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth surface matching the first concave surface.

[0142] Example 82 is the device of any of Examples 75-81, wherein when the device is in an actuated state, the first cold-formed surface remains concave without substantial wrinkling and the second cold-formed surface is transformed to a convex surface without substantial wrinkling.

[0143] Example 83 is the apparatus of Examples 73-82, wherein the first chamber is hermetically sealed along the entire perimeter.

[0144] Example 84 is the device of any of Examples 73-83, wherein the dispensing section is connected to the second chamber, the dispensing section holding the shaft of the applicator.

[0145] Example 85 is the device of Examples 73-84, wherein the first layer and the second layer are adhered to one another by heat sealing.

[0146] Example 86 is the device of any of Examples 73-85, wherein the first layer and the second layer are adhered to one another in the transition area and around the first and second chambers in the unactuated state.

[0147] Example 87 is the device of Example 86, wherein the transition area has reduced adhesion between the first layer and the second layer compared to other areas around the first chamber and the second chamber.

[0148] Example 88 is the device of Examples 73-87, wherein the brush head of the applicator is within the second chamber.

[0149] Embodiment 89 is the device of embodiments 73-88, wherein during the activated state, the brush head of the applicator enters the transition zone.

[0150] Embodiment 90 is the device of embodiments 73-89, wherein the dental composition is a cement, an adhesive, or a fluoride coating.

[0151] Example 91 is a device for storing and dispensing a flowable dental composition, the device comprising first and second layers forming a first chamber, a transition area, and a second chamber for containing the flowable dental composition, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the device including an unactuated state and an actuated state, wherein when in the unactuated state a substance is retained in the first chamber, and when in the actuated state a portion of the second surface substantially irreversibly deforms in response to pressure applied to the first chamber, thereby dispensing the substance through the transition area and into the second chamber.

[0152] Embodiment 92 is an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, and an applicator held within the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, wherein pressure applied to the first chamber can selectively open the transition area, thereby allowing fluid communication between the first chamber, the transition area, and the second chamber.

[0153] Embodiment 93 is a device for storing and dispensing a flowable dental composition, the device comprising first and second layers forming a first chamber for containing the flowable dental composition, a second chamber, and a transition area, and an applicator retained in the second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, the device including an unactuated state and an actuated state, wherein when in the unactuated state a first volume of the dental composition is retained in the first chamber and when in the actuated state a second volume of the dental composition in the first chamber is less than the first volume.

[0154] Embodiment 94 is an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, an applicator held within the second chamber, and a light blocking portion for protecting the flowable dental composition from premature hardening.

[0155] Embodiment 95 is an apparatus for storing and dispensing a flowable dental composition, the apparatus comprising first and second layers forming a first chamber for containing the flowable dental composition, a transition area, and a second chamber, the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer, and an applicator held within the second chamber, wherein the second concave surface substantially irreversibly deforms in response to pressure applied to the first chamber to form a smooth convex surface matching the first concave surface.

[0156] Example 96 is a method of making a device for storing and dispensing a flowable dental or orthodontic composition, the method including providing a first layer, cold forming the first layer thereby partially forming a first chamber and a second chamber, filling the first chamber with the flowable dental or orthodontic composition, providing a second layer, cold forming the second layer thereby partially forming the first chamber and the second chamber, sealing the second layer to a surface area of ​​the first layer, leaving the first chamber and the second chamber open, forming a dispensing area, and forming a transition area between the first and second chambers and within the dispensing area that can be selectively opened, die cutting a desired shape of the device, and partially cutting the first layer and the second layer with a notch for a light blocking portion.

[0157] Example 97 is the device of Examples 1-95, further comprising a dispense zone formed between the first layer and the second layer, the dispense zone comprising a first flow barrier and a second flow barrier.

[0158] Example 98 is the device of example 97, wherein the first flow barrier and the second flow barrier are configured in a wave shape.

[0159] Example 99 is the device of Examples 1-95, further comprising a dispensing area, wherein when in an actuated state, a portion of the second surface substantially irreversibly deforms in response to pressure applied to the second chamber, thereby dispensing substance through the dispensing area and into the second chamber.

Claims

1. An apparatus for storing and dispensing a flowable dental composition, the apparatus comprising: a first layer and a second layer that form a first chamber for containing the flowable dental composition, a transition zone, and a second chamber; an applicator held within the second chamber; the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer; the apparatus including a non-operating state and an operating state, wherein in the non-operating state a substance is held within the first chamber, and in the operating state a portion of the second surface is substantially irreversibly deformed in response to a pressure applied to the first chamber, whereby the substance is dispensed through the transition zone into the second chamber, and the first concave surface and the second concave surface are cold formed.

2. When the apparatus is in the non-operating state, the first cold formed surface is concave and the second cold formed surface is concave, and when the apparatus is in the operating state, the first cold formed surface maintains its concave shape and the second cold formed surface is deformed to a convex shape, whereby the flowable dental composition is dispensed from the first chamber through the transition zone. The apparatus according to claim 1.

3. In response to a pressure applied to the first chamber, a portion of the second cold formed surface is substantially irreversibly deformed to form a smooth surface that aligns with the first concave surface. The apparatus according to claim 1.

4. When the apparatus is in the operating state, the first cold formed surface maintains its concave shape without substantial wrinkling, and the second cold formed surface is deformed to a convex shape without substantial wrinkling. The apparatus according to claim 1.

5. An apparatus for storing and dispensing a flowable dental composition, the apparatus comprising: a first layer and a second layer that form a first chamber for containing the flowable dental composition, a transition zone, and a second chamber; an applicator held within the second chamber; the first chamber having a first concave surface formed in the first layer and a second concave surface formed in the second layer; An apparatus in which the transition region is selectively opened by a pressure applied to the first chamber, thereby enabling fluid communication between the first chamber, the transition region, and the second chamber. **Claim 6** The first concave surface and the second concave surface are cold formed, and when the apparatus is in a non-operating state, the first cold formed surface is concave and the second cold formed surface is concave. When the apparatus is in an operating state, the first cold formed surface maintains its concave shape and the second cold formed surface is deformed into a convex shape, whereby the flowable dental composition is dispensed from the first chamber through the transition region. The apparatus according to claim 5.

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