JP2013503019A - Administration device and product administration method - Google Patents

Abstract

The dispensing device comprises a package having at least one compartment having a flexible wall portion, a fluid transfer device, and a backing. During administration, the backing supports the package to facilitate squeezing the product out of the package via the fluid transfer device. A method of administering a product from such a package is also provided.
[Selection] Figure 2e

Description

  The present disclosure relates to a device for dispensing a filled product. More specifically, the present disclosure provides for dispensing (liquid supply) a filled product comprising a unit dose filled package in which the packaged product is stored in one or more thin film or foil compartments. Relating to the device.

Summary of invention

  An apparatus for storing and administering a product comprising at least one first flexible wall and having at least one first compartment filled with an administrable fluid; At least one rigid backing and a fluid transfer device for moving the product from the fluid compartment to a target location in a desired manner. Prior to use, the product is hermetically separated from the fluid transfer device by a fragile outlet seal. The frangible seal is broken and fluid communication is provided between the administrable fluid and the fluid transfer device. This configuration is operated so that the rigid backing squeezes the package, thereby allowing the administrable fluid to be dispensed from a fluid transfer device.

  The present disclosure includes a dosage package comprised of portions of a thin film or foil (both hereinafter referred to as “webs”) sealed around at least one chamber, as well as breaking the chamber to It relates to the field of means that allow the contents of a package to be administered.

  US Pat. No. 5,131,760 discloses a package that can contain a fluid material that breaks the package in a controlled manner by applying finger pressure from the thumb and index finger to the package. Can be released from the package by allowing the fluid material contained within the package to be released. The package comprises a chamber that receives the fluid material released from the containment chamber after the containment chamber has been ruptured by finger pressure so as to control the rate and method of releasing the fluid material from the package. One disadvantage of the apparatus taught by US Pat. No. 5,131,760 is that the size of the package is substantially larger in the first place and is further expanded when the receiving chamber is fused to the outlet chamber. . This makes it difficult to effectively squeeze out the contents of the package by pushing down the flexible wall directly with a finger or palm. Therefore, it is desirable to have a dosing package with more effective and practical squeezing capabilities. Further, US Pat. No. 5,131,760 does not disclose a fluid transfer device such as a hypodermic needle or nozzle at the exit of the package, thus limiting the use of the package.

  US Pat. No. 5,176,634 and US Pat. No. 6,203,535 each disclose a flexible container for storing and mixing diluent and drug. The container incorporates a plurality of compartments separated by a fragile seal, in which the diluent and drug are stored. The seal is broken by manipulating the container, thereby mixing the contents. An additional frangible seal separates the combined diluent and drug compartment from the outlet compartment for delivery to the patient from a standard IV arrangement. These patents teach embodiments of gravitational IV applications and in unit dose applicator applications (eg, less than 5 ml of administrable fluid, but rather 0.5 ml There are some drawbacks. As described above for the disadvantages of US Pat. No. 5,131,760, the fusion of the outlet compartment and the administrable fluid compartment increases the size of the package that needs to be pushed down to administer the contact, which is advantageous. Inconvenient to perform. In the above invention, the fragile seal break is achieved by folding the diluent compartment and pressurizing the administrable fluid compartment. This folding approach may be practical in some embodiments of the present disclosure that will be demonstrated later, but for diluent compartments as small as 2 ml, in some embodiments as small as 0.5 ml. Is generally not practical. Furthermore, US Pat. No. 5,176,634 and US Pat. No. 6,203,535 do not disclose means for forcing the contents.

  U.S. Pat. No. 4,955,871 discloses a single use disposable syringe. In the syringe, the product compartment is formed of two sheets of flexible thermoplastic material having an extended central portion that forms a pair of convex domes. Both domes can be compressed by applying force directly with two fingers. A product in accordance with the present invention is currently commercialized under the product name Unitec ™ by Becton Dickinson and Company (Franklin Lakes, NJ).

  The speed of squeezing the dose placed in the syringe depends on the physiology of the user's finger pad and the finger pressing against the package, and therefore complete or consistent dose delivery cannot be ensured. Another disadvantage of this embodiment is that the device is held between two fingers at one end of the device, while the needle is fixed at the other end of the device with only the membrane in communication between the two ends. It is to be done. Thus, the tightness control in the needle and the user's hand is limited.

  In the present disclosure, the fluid transfer device has rigidity and accuracy by incorporating a rigid backing that communicates the user's hand and the fluid transfer device through the rigid backing.

  The present disclosure preferably includes a package having at least one substance compartment pre-filled with at least one first flexible wall and prefilled with an administrable fluid, at least one rigid backing, A filled unit dose product dispensing device is disclosed comprising a fluid transfer device for moving in a desired manner from a fluid compartment to a target location. Prior to use, the administrable product is hermetically separated from the fluid transfer device by a frangible outlet seal (hereinafter sometimes referred to as an “exit seal”). In use, the outlet seal is broken to provide fluid communication between the administrable product and the fluid transfer device. This arrangement is to help the rigid backing effectively squeeze the product out of the package via a fluid transfer device.

  In the present disclosure, the administrable fluid compartment is squeezed directly or indirectly by squeezing the flexible wall of the administrable fluid compartment with a finger. The “footprint” of a compartment can be viewed as the actual area of the compartment that would need to be squeezed to effectively release the contents of the compartment. In many flexible wall package configurations, the “footprint” is around the administrable fluid compartment, and the flexible wall is sealed to the second wall around it.

  The package comprises at least one flexible wall that can be depressed to pressurize the product in at least one compartment of the package. The product can be squeezed out of the package by pushing the flexible wall directly against the rigid backing or by an instrument such as a compression panel that pushes the flexible wall against the rigid backing. . The flexible wall is sealed to at least one additional wall around the at least one compartment so as to form two types of seals, a permanent seal and a fragile seal. Permanent seals are installed at the periphery of the compartment unless it is necessary to break the seal to provide fluid communication between the compartment and the adjacent compartment or between the compartment and the fluid transfer device. US Pat. No. 6,203,535, US Pat. No. 5,176,634, and US Pat. No. 5,131,760 combine a fragile seal with a permanent seal to provide a flexible package. Disclosed are materials and methods of forming, the entirety of which is incorporated herein by reference. One multilayer material suitable for making frangible seals and permanent seals in a controlled manner in a specified area of the package is X203-2113-L from PerfecSeal (Oshkosh, Wis.). . The adhesive layer of this material seals at about 130 ° C but forms a weak bond and forms a strong permanent bond when sealed at about 170 ° C. In some embodiments, the package comprises a number of compartments containing various substances of the administrable product, separated by a fragile seal, the fragile seal being broken so that they are in operation during operation. The compartments are fused so that the substances can be mixed into an administrable product. In some embodiments, at least one of the compartments contains a diluent and at least one of the compartments contains a dry substance. The dry substance can take the form of free-flowing powders, compressed powders, granules, spheres, solids, pills, freeze-dried cakes, coatings attached to a solid matrix, dry substances related to the solid matrix, and the like. In some embodiments, at least one compartment contains the diluent and at least one additional compartment contains the dry form of the vaccine or drug. These compartments are fused prior to administration to reconstitute the vaccine or drug.

  The fluid transfer device can be any mechanism suitable for transporting the product from the package to the target location in a preferred manner. The fluid transfer device can be formed in or between the walls of the package, or the fluid transfer device can be a part or assembly associated with the package as an insert or fitting. Alternatively, the fluid transfer device can be implemented between the flexible wall and the rigid backing, or can be implemented within the rigid backing or as a deposit on the rigid backing. Fluid transfer devices include droppers; spray nozzles; topical, eye, nose or ear applicators, droppers or sprayers; brushes, sponges, or other absorbent media for thinly coating the contents; tubes, cannulas Or a capillary; a needle for insertion into tissue, a rigid or flexible cannula or other sharp object; a connector for communicating with a fluid system, a luer slip connector, a luer lock connector; It can take various forms or forms, such as: an extension to one of the above, a coupler, or a connector.

  The rigid backing can be made of at least one rigid member, and the package can be squeezed against the rigid member to release the product from the fluid transfer device. In some embodiments, the rigid backing also assists in squeezing at least one compartment of the package to fuse multiple compartments prior to delivery or to break the outlet seal to provide fluid communication with the fluid transfer device. Or establish. The rigid backing further provides robust physical communication between the user's hand and the fluid transfer device, so that a user with a rigid backing in hand can move and position the dispensing end of the fluid transfer device. This is particularly important when the fluid transfer device is a hypodermic needle, eye dropper or other fluid transfer device that requires sensitivity and accuracy in handling.

  In some embodiments, the package is permanently attached to the rigid backing. In other embodiments, the package is attached to a rigid backing in use.

  In some embodiments, the rigid backing is one of the walls of the package.

  In some embodiments, the rigid backing provides protection to and from the fluid transfer device before and after use.

  In some embodiments, the rigid backing contains a flow regulator to prevent the administrable fluid from exploding through the fluid transfer device when the package is broken.

  In some embodiments, the rigid backing contains a check valve to prevent backflow from the fluid transfer device into the package.

  In another embodiment, a peelable flexible cover, such as that proposed in US Pat. No. 6,203,535, further reduces the exposure of the product or material and oxygen from and into the package. Or attached to the surface of the package to cover at least a portion of the one or more compartments to reduce moisture migration.

FIG. 5 shows a preferred embodiment where the package comprises a single compartment and the fluid transfer device is an insertion equipment having the shape of a luer slip connector. FIG. 6 shows a preferred embodiment in which the package comprises two compartments separated by a fragile seal and the fluid transfer device is an insertion equipment in the form of a luer slip connector. FIG. 5 shows another preferred embodiment where the package comprises two compartments, each compartment being connected to a fluid transfer device via a separate outlet seal. FIG. 6 shows another preferred embodiment where the fluid transfer device is an external accessory attached to the wall of the package. FIG. 5 shows another preferred embodiment in which the fluid transfer device is formed by a package wall. The package comprises two sheets of material that are sealed together around a plurality of compartments. FIG. 6 shows another preferred embodiment where the package comprises a sheet of material sealed to the backing around the compartment. FIG. 6 illustrates another preferred embodiment in which a fluid transfer device is formed between a package and a backing. FIG. 6 shows another preferred embodiment in which a fluid transfer device is embedded between the package and the backing, the package comprising a plurality of compartments. FIG. 6 shows another preferred embodiment in which the fluid transfer device is embedded in a backing. FIG. 6 shows another preferred embodiment where the fluid transfer device is a hypodermic needle in communication with the package via a plastic hub. FIG. 6 shows another preferred embodiment where the fluid transfer device is a hypodermic needle in communication with the package without a plastic hub. FIG. 6 shows another preferred embodiment where the device comprises a sterile needle wrap. FIG. 6 shows another preferred embodiment with a fluid transfer device breaking mechanism at the end of use. FIG. 5 shows another preferred embodiment where the backing comprises a spring function for biasing the compression panel relative to the backing at a desired position. FIG. 6 shows another preferred embodiment with a latching arm for limiting the movement of the compression panel relative to the backing. FIG. 6 shows another preferred embodiment where the package is attached to the surface of the backing. FIG. 6 shows another preferred embodiment where the apparatus comprises a flow regulator. FIG. 6 shows another preferred embodiment in which the reservoir product compartment is positioned over the crease line of the backing. FIG. 6 shows another preferred embodiment that does not include a compression panel.

  Referring to FIG. 1, a preferred embodiment of a device (hereinafter “device”) 10 in the form of a preferably filled unit dose administration package of the present disclosure is shown. FIG. 1b, which is a detailed view of FIGS. 1a and 1a, shows the entire device 10 before activation. The device 10 generally comprises a package 9 comprising a product compartment 12 pre-filled with a single dose of administrable product, partially defined by a flexible wall 11, and the product desired for a target location. A fluid transfer device 14 for communicating in a method and a rigid backing 16 for supporting the package 9 are provided. The backing 16 is joined to the compression panel 17 via a hinge 18. The compression panel 17 can be operated to rotate along the hinge 18 and depress the compartment 12 to cause the product to be dispensed from the fluid transfer device 14. The device 10 further comprises a fragile outlet seal 13 that seals and separates the administrable product in the compartment 12 from the fluid transfer device 14 until activated, the outlet seal exceeding a predefined pressure threshold by the product compartment 12. Can be broken when pressurized. The first flexible wall 11 is permanently sealed along the first peripheral margin 15 of the first section 12 and the second peripheral margin of the first section 12. Along a non-permanent seal to define a fragile outlet seal 13 located between the product compartment 12 and the fluid transfer device 14, so that when the outlet seal is ruptured, Fluid communication is established between the product and the fluid transfer device 14. In one embodiment, this configuration creates a pressure in the product compartment 12 by depressing the package 9, and this pressure is weak between the first flexible wall 11 and the second wall of the compartment 12. The outlet seal 13 is broken by breaking the seal to establish fluid communication of the product with the fluid transfer device 14, thereby activating the device 10 and dispensing the product to the target location in a defined manner. belongs to. The compartment 12 can be squeezed directly by the thumb or by folding the compression panel 17 over the rigid backing 17 so that the package 9 is sandwiched between the compression panel 16 and the backing 17. Alternatively, the package 9 can be pushed down by another machine or instrument made to operate the device, or by other means as required.

  The package 9 comprises at least one flexible wall 11 made of a thin laminate (commonly referred to as “web”) such as a thin film or foil sealed around the product compartment 12, The seal 15 has a seal on the peripheral portion 13 that separates under pressure within 12 but the rest of the seal 15 is a permanent seal that does not separate under the limit pressure within the product compartment 12. The permanent seal 15 is continuous along the outlet seal 13 so that when the outlet seal 13 is broken, the fluid passage is shaped to ensure that the administrable fluid flows with the fluid transfer device 14.

  In some embodiments, the flexible wall 11 is directly on the rigid backing 19 such that the product compartment 12 and the outlet seal 13 are formed between the rigid backing 19 and the flexible wall 11. Sealed.

  In another embodiment, the package 9 has at least one additional flexible wall 11 such that the compartment 12 and the outlet seal 13 are formed and inserted between the flexible wall 11 and the additional wall. Established by sealing to a wall (not shown). The advantage of such an embodiment is that the package can be manufactured on a more general Form-Fill-Seal or Fill-Seal line and back in subsequent manufacturing stages. It can be relied on.

  In another embodiment, the compartment 12 and the outlet seal 13 are partially formed between the flexible wall 11 and the rigid backing 16, and the flexible wall 11 and at least one additional wall are Combinations of certain previous embodiments are made to form in part in between.

  The rigid backing comprises a rectangular flap 16 joined to a rectangular compression panel 17 along one end through a thin flexible portion forming a hinge 18 and defining a crease line. Depending on the application requirements and preferred manufacturing format, the hinge 18 is manufactured as a molded living hinge or other shape and type of rotary hinge or flexible joint solution known in the art. be able to. The rigid backing 16 can be made from a variety of materials including molded plastics, plastic sheets or boards (single layer, multilayer, extruded, blown, laminated, etc.), sheet metal, cast alloys, paperboard, composite materials, ceramics, or combinations of the above It can be made by various processes. In some embodiments, the living hinge 18 can be molded integrally with the backing. In other embodiments, the backing 16 and the compression panel can be made as one single piece. If the backing 16 is made from a sheet or board, the thin part to form the living hinge is formed by a local cutout (machining, vapor deposition, laser cutting, etc.) part of the wall thickness along the specified crease line By selectively removing certain materials from the bulk material composition (such as removing the thermoplastic with heat and leaving behind thermosetting fibers or mashes) or secondary parts It can be formed by compression or thermoforming. If the backing 16 is made from sheet material, the living hinge can be formed by a flat portion of the sheet, while the backing 16 and compression panel 17 are reinforced by folding the edges of the backing 16 and compression panel 17. Is done. In some embodiments, the flexibility of the living hinge 18 relative to the stiffness of the backing 16 and compression panel 17 is achieved at least in part by material processing such as local heat treatment, selective surface treatment, selective composition change. . In some embodiments, the living hinge 18 can be formed by a layer of additional flexible material inserted along a specified crease line between the rigid backing 16 and the compression panel 17. . In one embodiment, the flexible layer is a label. Additional layers can be locally attached along the edge closest to the crease line, or the additional layers can cover a wider portion of the backing 16 and / or compression panel 17 or the entire facet. it can. The added layer can be pre-printed with the desired graphics or information. In other embodiments, the living hinge portion 18 can be made from an elastic material. The elastic material portion can be formed using one of the means known in the art, including prefabricated and attached between flaps, co-molding, co-extrusion, insert molding, and the like. In one embodiment, it is substantially rigid so that the wall of the package 9 is the backing. In one embodiment, the wall of the package 9 is substantially rigid and wide so that it becomes a compression panel. Folding hinge 18 may take the form of a door hinge whose axis passes through a fixture (such as a hole) in each of flaps 16 and 17 along the crease line, or takes the form of a socket and meniscus arrangement common in various plastic products, etc. It will be apparent to those skilled in the art that other methods can be formed. The backing 16 and the compression panel 17 can have any shape and are not limited to the largely rectangular shape evident in FIG.

  The fluid transfer device 14 comprises a proximal end in the form of a pouch insert fitment commonly used in pouch containers for coupling a cup or spout to a flexible package. This equipment, when activated, has a flexible wall 11 and an additional wall (not shown) so that the product flowing in the fluid passage 13 is restricted and flows into the internal passage of the fluid transfer device 14. It is sealed in a liquid-tight manner. The distal end of the fitting 14 is in the form of a male luer slip connector commonly used in medical fluid systems associated with drug delivery or fluid management. The luer slip connector 14 serves as a spout for direct administration of the product to the target or to communicate with the female luer connector of another device or system, such as a hypodermic needle hub or Y site injection point of the injection system. Can be used for Thus, the fluid transfer device 14 in the form of a luer slip connector creates various possible applications of the dispensing package 10 of the present disclosure. In one embodiment, the device accepts a hypodermic needle and functions as a medical syringe. In another embodiment, the device 10 is a prefilled unit dose drug for introduction into the infusion set through the Y site. The fluid transfer device can include a replaceable closure for resealing the package. In other embodiments, the distal end of the fluid transfer device 14 is a hypodermic needle attached directly to the fitting 14; a connector to a tube, capillary or hose; a luer lock connector; Foam or other absorbent pad; spray head; nasal spray or nasal drop; oral dropper or eye dropper; irrigation nozzle; mini needle or needle; microneedle or microneedle array; jet injector; It is of another shape, such as an extension / coupling unit for one of them.

  Referring now to FIG. 1d, which is an enlarged detail view of FIGS. 1c and 1c, the device 10 is shown in an activated state, in which the outlet seal 13 is separated (fragile from both figures). It can be seen that the part is swollen compared to FIGS. 1 a and 1 b), fluid communication is established between the compartment 12 and the fluid transfer device 14. The exit seal is disconnected either by applying a force directly to the compartment 12 (eg, pressing down with a thumb), folding the rigid backing 19 and squeezing the product compartment or by another device that meets this approach. It should be understood that The outlet seal 13 is defined as a portion that is manufactured such that the force required to sever the seal is less than the force required to sever the permanent seal 15. U.S. Pat. No. 5,176,634, U.S. Pat. No. 6,203,535, and U.S. Pat. No. 5,131,760 describe a fragile seal within a package of other permanent seals. Disclosed are materials, methods and processes for manufacturing selected areas. One concern with fragile seals is that at the moment when the fragile seal 13 is broken, the excessive pressure generated to break the fragile seal causes an explosion of the product through the fluid transfer device 14. In one embodiment, at least a portion of the fluid passage between the compartment 12 and the outlet of the fluid transfer device 14 limits the cross-sectional area of the passage, extends the length of the flow path, or drag and pressure drop. By properly arranging the features in the flow path to increase the flow rate, it acts as a flow restrictor. In another embodiment, the outlet seal 13 is made such that the strength of the seal gradually or gradually decreases along the direction of the flow path. Thus, although a certain critical pressure is required to initiate the fragile seal separation, the subsequent front of the separation is such that the fragile portion 13 is completely pulled away and the product compartment 12 and the fluid transfer device 14 are separated. Until fluid communication is established, lower pressure is required for disconnection, etc., at which point the fluid passage 13 is opened and resistance to the dosing flow is relatively low.

  FIG. 1 e shows the device in the dosing direction, in which the compression panel 17 can be folded over the rigid backing 16 so that the compartment 12 can be squeezed between the compression panel 17 and the rigid backing 16. To.

  In another embodiment, the device incorporates a one-way valve to prevent refilling of the package 9 after starting to use the device. This valve can be incorporated in a fluid transfer device or in a fluid passage or compartment and can be formed or placed between the walls of the package, between the package and the backing, or within the backing. it can.

  Referring now to FIG. 19, another preferred embodiment without a compression panel is shown. The package 9 can be squeezed by pushing down the thumb directly or by pushing down a separate compression panel. In one embodiment, the device is associated with an instrument made to operate the device comprising a compression panel for pushing down the package 9. The compression panel is not limited to the flat pad apparent in FIG. 1, but can take other forms known in the art such as curved panels and rollers.

  Referring now to FIG. 2, there is shown another preferred embodiment 20 that is similar to the embodiment of FIG. In this case, the first compartment 12 contains the first substance, and the flexible package 9 comprises a second compartment 21 filled with the second substance. Prior to activation, the two compartments are hermetically separated by a second fragile seal 13 (hereinafter sometimes referred to as a “mixed seal”), Sometimes it is broken by pressurizing one or both of the compartments 12 and 21. The first material and the second material need to be mixed to form the administered product (or mixed product) prior to administration. FIG. 2 a shows the device 20 in a stationary position, showing the first compartment 12 and the second compartment 21 separated by a mixing seal 22 prior to activation. FIG. 2b shows a partial top view of the device 20 showing the shape of the flexible wall 11 in more detail. The pattern of the mixed seal is similar to a saw blade, which causes stress concentration during activation and promotes fracture of the mixed seal 22.

  FIG. 2c shows a partial side view of the device 20 before activation. Product compartment 12 and second compartment 21 have a relatively deep shape (ie, a deep cavity with a small sealing footprint). Fluid pouches or blisters are generally made relatively shallow, and the unique shape of the current compartments 12 and 21 reduces the pressing surface during activation and administration, increases the pressure of the material, and squeezes the product It is advantageous to make the dispensing more effective. If the compartments 12 and 12 are deep cavities, it is also possible to increase the indentation travel distance, thereby providing a continuous pressure so that the two compartments 12 and 21 form one continuous chamber. The fragile seal 22 can be broken from end to end. For a conventional pouch where the compartment is shallow compared to the compartment in this embodiment, after the initial break there should be no further indentation travel to allow the entire fragile seal to be forcibly removed, so that the fragile seal is fully It becomes even more difficult to break.

  FIG. 2e, which is an enlarged detail view of FIGS. 2d and 2d, merges the second compartment 21 and the first compartment 12 of the package 9 in a state prior to activation (ie before breaking the outlet seal). The device 20 is shown after it has been allowed to. The new fused compartment 12 '(hereinafter also referred to as "compartment 12" or "product compartment") takes the form of a continuous chamber that facilitates mixing of the contents of compartments 12 and 21 of the original package. In some embodiments, the second material is a dry powder, gel, or paste or solid that sticks in the corners and tends to be difficult to dissolve, and the smooth integral shape of the fused compartment 12 'is the second Facilitate mixing of the first material with the first material. In FIG. 2e, it is clear that the outlet seal 13 is in a flat state prior to activation. The pressure required to disconnect the outlet seal 13 is higher than the pressure required to disconnect the mixing seal 22, and therefore the device before completely disconnecting the mixing seal 22 and thoroughly mixing the contents of the two compartments 12 and 21. Avoid situations where 20 is activated to form an administrable product.

  FIG. 2g, which is a detailed view of FIGS. 2f and 2f, shows after the product compartment 12 'has been further pressurized (higher than the pressure used to fuse the compartments 12 and 21) and the outlet seal 13 has broken. The device 20 is shown in a state before activation. In FIG. 2g it is clear that the fluid passage 13 is inflated after the fragile outlet seal has broken. In another embodiment, the break force threshold of the outlet seal 13 is not higher than the break force threshold of the mixed seal 22.

  FIG. 2 h shows the device 20 in the dispensing position, in which the compression panel 17 is folded over the backing 16 to squeeze the product compartment 12 ′ and allow the product to be dispensed from the fluid transfer device 14. In some embodiments, the mixing step, the activation step, and the administration step illustrated above as a series of sequential steps are combined to fold and press down the compression panel 17 over the backing 16 in a single series. Will cause the above sequence.

  In another embodiment, the dosing package comprises at least another compartment that is fused to the first compartment 12 in the same manner as the second compartment 21 does. Embodiment 20 is particularly advantageous when the stability of the finished product can be extended by leaving the particular first material separate from the second material of the product until use. In one embodiment, the second compartment contains dry medical substances such as vaccines and antibiotics that need to be reconstituted with diluent before delivery. In other embodiments, the second substance is a thick gel foam biopharmaceutical (which extends the shelf life of the second substance) that needs to be diluted with the first substance to be delivered through a fine needle. ).

  Referring now to FIG. 3, the package 9 includes two first compartments 12 ′ that are activated and administered in parallel in the same manner as performed in the single compartment embodiment 10 of FIG. Another preferred embodiment 30 comprising 12 ″ is shown. The fluid passage 13 comprises at least one outlet seal, interconnecting the compartments 12 ′ and 12 ″ and the compartments 12 ′ and 12 ′ and The contents of 12 "are directed to the fluid transfer device 14. Each of the compartments 12 'and 12" forms a first compartment 12' and 12 to form a product, as shown in embodiment 20 of FIG. It will be apparent to those skilled in the art that a pair of material compartments to be fused to can be incorporated. Further, an embodiment similar to embodiment 30 can be implemented in a single package or multiple packages. It will be apparent to those skilled in the art that more than two compartments can be provided in parallel. In another embodiment, the common portion of the fluid passageway 13 for compartments 12 'and 12 "is connected to the fluid transfer device 14. With features that facilitate mixing of the products in the two compartments 12 ′ and 12 ″ before reaching them. In another embodiment, the fluid transfer device comprises a mixing element for mixing the substance of the product. , Between the walls of the package 9, between the package 9 and the backing 16, and within the backing 16, at least in part.

  Referring now to FIG. 4a, another preferred embodiment 40 is shown in which the fluid transfer device 41 is a fitting joined to the outside of the flexible wall 11. FIG. 4 b is an exploded view of the device 40. The proximal end of the equipment 41 takes the form of a flange for sealing to the surface of the wall 11 around the opening 42 of the fluid passage 13. The distal end of the fluid transfer device 41 takes the form of a luer slip connector.

  Referring now to FIG. 5, another preferred embodiment 50 is shown in which the fluid transfer device 51 is simply the distal end of the fluid passage 13 shaped like a tip 51. FIG. 5a shows an arrangement in which the fluid passage 13 leads to the crease line 18 of the backing 16, in which the opening 52 of the hinge portion 18 between the backing 16 and the compression panel 17 is fluid. The administration tip 51 of the passage 13 is received. Therefore, the fluid transfer device 51 is integrated in the package 9. FIG. 5 b shows the administration position of the device 50. The compression panel 17 is folded over the backing 16 so that a fused product compartment (not shown) is squeezed between the two compartments. The dispensing tip 51 indicates that the contents can be conveniently dispensed to the target in the opening 52 when the device 50 is folded. The advantage of this arrangement is that it avoids the equipment incorporated in some of the above embodiments, which adds manufacturing cost and complexity to the manufacturing equipment. FIG. 5 c is an exploded view of the device 50 showing the second wall 53 sealed with a flexible wall 11 to form the compartment 12. The administration tip 51 can be a) a long or short tip, b) a wide or narrow outlet, c) a single or multiple outlets, d) an irrigation, drip or spray tip, e) a topical applicator or dropper. , Etc. can be formed in various shapes to support specific applications.

  Referring now to FIG. 6, there is shown another preferred embodiment 60 that is substantially the same as embodiment 20 of FIG. 2, where the flexible wall 11 is the back as shown in FIG. 6a. The pad 16 and the compression panel 17 are covered with the entire flexible wall 11. The compression panel 17 can be made to match the compartment footprint. Furthermore, as shown in an exploded view in FIG. 6b, the flexible wall 11 is sealed directly against the backing 16 to provide the package 9 (production section 12, second fragile seal 22, second 2 compartments 21 and a fragile seal 13). The backing 16 can be made from a substantially rigid thin film or foil sheet and can be printed with information such as graphics or text.

  Referring now to FIG. 7, another preferred embodiment 70 is shown in which the fluid transfer device is partially embedded within the backing 16. FIG. 7a shows the device 70 in the pre-activation position. The fluid passage 13 faces the crease line 18, and an opening 52 between the backing 16 and the compression panel 17 receives the pointed tip of the flexible package 9 at the crease line 18. The fluid passage 13 ends in front of the tip 72, thereby slightly blocking the outlet channel and restricting product flow to the tip 72. FIG. 7b shows the device 70 in the administration position. The dispensing tip 72 exits through the opening 52 in the crease line 18 to allow convenient dispensing of the product.

  FIG. 7 d, which is a detailed view of FIGS. 7 c and 7 c, is an exploded view of the device 70. The flexible wall 11 is sealed against the second wall 73 to form the package 9. When the through hole 74 of the second wall 73 is aligned with the distal end of the fluid passage 13 and the outlet seal 13 is separated, the product 9 flows through the fluid passage 13 and penetrates the additional wall 73. Exit from hole 74. The fluid transfer device is a groove 71 in the backing 16, which is covered and sealed with an additional wall 73 to form a closed fluid passageway between the hole 74 and the dispensing tip 72. Accordingly, the fluid passage is partially inserted between the rigid backing and the package 9. An administration tip is formed between the distal end of the groove 71 and the edge of the additional wall 73. The distal end of the groove can be formed in a variety of shapes to produce the desired dosage pattern, including single nozzle, multiple nozzles, long or short nozzles, irrigation nozzles, drop nozzles, spray nozzles, and the like. Accordingly, at least a portion of the fluid transfer device is partially inserted between the rigid backing and the package 9.

  Referring now to FIG. 8, there is shown another preferred embodiment 80 that is substantially the same as embodiment 70 of FIG. 7, in which embodiment 80 comprises a plurality of second embodiments, as is apparent in FIG. 8a. One compartment 12 'and 12 "and an additional compartment 21' and 21" are provided in parallel. FIG. 8 b is an exploded view of the device 80, exposing a T-shaped groove 81 that forms a closed fluid path between the section and the dispensing tip 72 when sealed with the package 9 at the top. . In one embodiment, the groove 81 further comprises features for enhancing the mixing of the flow coming down from the different fused sections. It will be apparent to those skilled in the art that similar embodiments can have more than two sets of compartments in parallel, implemented in one or more packages.

  Referring now to FIG. 9, another preferred embodiment 90 is shown. Embodiment 90 is substantially similar to embodiment 70 described above, in which the fluid transfer device is fully embedded in the backing 16. FIG. 9 a shows the device 90 in a pre-activated position, in which the administration tip 91 is seen in the opening 52 of the crease line 18.

  FIG. 9b shows the device 90 in the dispensing position, in which the backing 19 is folded and the dispensing tip 91 emerges from the opening 52 to conveniently dispense the product from the fused compartment.

  FIG. 9 c, which is an enlarged detail view of FIGS. 9 c and 9 c, is an exploded view of the device 90. The hole 74 in the second wall 73 is aligned with the hole 91 in the backing 16 that communicates with the internal fluid passage 93 of the backing 16 that leads to the dispensing tip 91 in the form of a dropper. The dispensing tip can be formed in a variety of forms and can accept additional components to form a desired nozzle shape for a particular application such as irrigation, spray, jet, and the like. Alternatively, the fluid transfer device can simply be an adapter, connector or extension to the type of nozzle described above. Accordingly, embodiment 90 illustrates a fluid transfer device that is integrated within backing 16 and a fluid passage that is partially integrated within backing.

  The fluid transfer device comprises a fluid passage from the product compartment or fused compartment to the dispensing tip, a) between the flexible wall 11 and at least one additional wall, and b) the flexible wall 11. 5, 7, and 9 are inserted between the backing 16, c) through an internal passage in the backing 16, and d) through additional components that communicate with the backing 16. It will be apparent to those skilled in the art that any combination of fluidic devices can be combined.

  Referring now to FIG. 10, another preferred embodiment 100 is shown in which the device 100 is a unit-dose prefilled reconstitution and delivery hypodermic syringe. FIG. 10 shows a first side of the device 100 that is similar in shape and function to the device of the embodiment 90 of FIG.

  FIG. 10 b shows the second side of the device 100 in a pre-activated state, where the fluid transfer device incorporates a hypodermic needle 101 and the proximal end of the hypodermic needle 101 is connected to the needle hub 102. You can see that. Needle hub 102 is liquid tightly contained within the opening of backing 16 and receives the product after activation. The recess 103 of the compression panel 17 houses the distal end of the needle 101 and provides protection from mechanical damage to the needle 101 as well as protection from the needle stick to the user.

  FIG. 10c is a cross-sectional view of the device 100 in a pre-activation stage. The second compartment 21 contains an active medical ingredient 105 such as a dry powder, a lyophilized vaccine or a drug, and the product compartment 12 contains a diluent 104 for reconstitution of the dry active ingredient 105 when in use. The communication channel 13 (flattened and sealed in this position) leads to the vertical channel 106 of the hub 102 that is in fluid communication with the needle 101 and this arrangement is such that after activation, the fused compartment The fluid from the flexible package 9 flows exactly to the needle 101 when pressed down.

  FIG. 10d shows the device 100 after the first compartment 12 and the second compartment 21 of the package 9 have been fused to 12 'to create a product.

  FIG. 10 e shows the activated device 100 with the outlet seal 13 broken (shown inflated compared to FIG. 10 d) to form a fluid passageway (13) with the needle hub 102. .

  FIG. 10 f shows the device in the dispensing position, where the fused compartment 12 ′ is squeezed between the backing 16 and the compression panel 17 to squeeze the product from the compartment 12 ′ through the needle 101. put out. By folding the compression panel 17 over the backing 16, the needle 101 is exposed for convenient patient application. Those skilled in the art will appreciate that the series of sequential steps presented between FIGS. 10 c and 10 f can be performed as a single continuous operation by simply folding the compression panel 17 over the backing 16. Will. It will also be apparent to those skilled in the art that the needle 101 can be directly associated with the backing 16 to eliminate the needle hub.

  Referring now to FIG. 11, another preferred embodiment is shown that is substantially similar to the embodiment 100 of FIG. 10, in which the needle 101 is attached directly to the backing 16, thereby providing a hub. (102 in FIG. 10) is eliminated. The proximal end of the needle 111 is bent at a right angle toward the fluid passage 13. In this embodiment, the needle 101 is attached to the backing 16 by one of the means known in the art, such as an adhesive 112.

  Referring now to FIG. 12, another preferred embodiment is shown in which the device 120 comprises an integral sterilization cover. FIG. 12a shows that the device 120 includes a peel sterilization cover 121 attached directly to the concave surface 123 of the backing 16, forming a sterile area around the needle, keeping the needle sterile and protected until use. Indicates to continue. In one embodiment, the device 120 is sterilized in this configuration, without additional sterilization packaging for the entire device 120, so that the fluid transfer device 101 remains sterilized until use. In one embodiment, product 120 is sterilized by gamma radiation. In another embodiment, the cover 121 is made from a breathable web (Tyvec, Dupont, etc.) and the product 120 is sterilized by ETO. The wall around the concave surface 123 forms a cavity that protects the cover 121. The loose stub 122 facilitates peeling of the cover 121 before use.

  FIG. 12b shows the device 120 after the cover 121 has been removed. The living hinge 18 is arranged such that the living hinge 18 forms a continuous plane with the concave surface 123 to provide a plane for attaching the cover 121. The cover 121 can be removably joined to the concave surface 123 by an adhesive layer or welding, or by any other means known in the art. Needle 101 is connected to needle hub 102, which is connected to backing 16 in the same manner as embodiment 100 of FIG. The needle is protected in the groove 103 of the compression panel 17 until the compression panel 17 is folded to squeeze the package 9.

  FIG. 13 shows another preferred embodiment 130 that includes a mechanism for breaking the needle 101 at the end of use of the product 130. FIG. 13a shows the device 130 at the end of the dosing phase where the compression panel 17 is fully rotated in the direction of the arrow until the compression panel 17 is in full contact with the backing 16, and the product is fully squeezed out. . The living hinge is located approximately in the middle of the thickness of the backing 16, so that the compression panel 17 can be rotated both from a flat pre-use position. The needle 101 appears and is convenient for introducing the needle 101 to the patient.

  FIG. 13b shows that the compression panel 17 is rotated in the opposite direction of FIG. 13a in the direction of the arrow (ie about 360 degrees about the crease line 18) to bring the opposite side of the compression panel 17 and backing 16 into contact, The device 130 is shown after the fluid transfer device 101 has been disabled at the compression panel 17. Since the proximal end of the needle 101 is secured to the backing 16, the needle must bend and break when the compression panel 17 rotates, so the device 130 cannot be reused, i.e. in the package. The remaining product is not misused. Further, in this position, the tip of the needle 101 is protected from causing needle sticks after the product has been discarded. In one embodiment, the device 130 includes a feature that latches the backing 16 and compression panel 17 in a disposal position so that when the device 130 is folded into this position, the flap cannot be separated and the needle cannot be reached. I also do it.

  Referring now to FIG. 14, another preferred embodiment is shown. Two integral springs 141 that stretch between the backing 16 and the compression panel 17 are on the crease line 18 so that the compression panel is biased to first and second angular positions relative to the backing 16. On the other hand, it is arranged at an offset position. In one embodiment, the spring 141 is biased to a first stable position where the compression panel 17 is flat with the backing 16 and to a second stable position where the compression panel 17 is folded over the backing 16 in the dispensing position. To do. In another embodiment, the first stable position is when the compression panel 17 is partially folded over the backing 16, and when the device 140 is removed from the package and released from the flat position, The compression panel 17 clicks in the half-folded position.

  FIG. 15 shows another preferred embodiment. In this case, the rigid backing 16 and the compression panel are interconnected by a hinge 18. Furthermore, the backing 16 and the compression panel 17 are connected to each other by a plurality of pairs of cooperating joints in order to limit the pivotal movement of one of the pivot parts. Each of the two joints includes two segments 151 and 152 connected by a flexible hinge, the first segment 151 is connected to the backing 16 by a flexible hinge at one end, and the second segment 152 is a second segment. When the other end of 152 is connected to the compression panel 17 by a flexible hinge and the compression panel is pivoted, the compression panel 17, the backing 16, the first segment 151, and the second segment 152 are “four-bar mechanism”. Acts as follows. FIG. 15 a shows the device in a flat pre-activation position in which joint segments 151 and 152 are flat with backing 16 and compression panel 17. FIG. 15 b shows the device 150 with the compression panel 17 folded to a position where the compression panel 17 partially squeezes the first compartment to fuse the first compartment with the second compartment. At this time, the arm is folded and the second segment 152 prevents the compression panel 17 from further folding toward the backing 16, thereby activating the unintentional or uncontrolled compression of the package 9 and the device 150. Try to prevent the contents of the package from exploding. In order to dispense the contents of the device 150, a) the joint must be turned over to the opposite position, or b) the hinge between the segment 151 and the segment 152 must be broken. It will be apparent to those skilled in the art that other mechanical stops can be implemented that eliminate the explosion of the contents once the device is activated.

  Referring now to FIG. 16, another preferred embodiment 160 is shown in which the flexible package 9 is supported by a rigid backing only in use. FIG. 16a shows the device 160 in a pre-activation configuration. A first flexible wall 11 ′ and a second reciprocal package 9 are sealed around the first flexible wall 11 ′ and the second reciprocal flexible wall 11 ″. A product compartment 12 and a second formed by a flexible wall 11 ″, wherein the first flexible wall 11 ′ and the second reciprocal flexible wall 11 ″ are separated by a mixing seal 22. So as to form a compartment 21. An outlet seal 13 separates the second compartment 21 and the fluid transfer device 14. The proximal end of the fluid transfer device 14 is in the form of a pouch insert fitting and two possible Sealed between flexible walls 11 ′ and 11 ″. The distal end of the fluid transfer device 14 is a hypodermic needle 101 that is confined between the backing 16 and the compression panel 17 in a pre-use state, which acts as a needle protector. The fluid transfer device 14 further includes a platform 162 extending laterally, and a first flap 16 and a second flap 17 are joined to the platform 162 via a living hinge 18, and the backing 16 and the compression panel 17 are connected to each other. Each can be pivoted approximately 180 degrees toward the package 9 in the opposite direction. The backing 16 and compression panel 17 further comprise a cantilever spring portion 163 that extends from the distal end of the backing 16 and compression panel 17 toward the proximal end of the backing 16 and compression panel 17, respectively.

  FIG. 16 b shows the intermediate position during rotation of the backing 16 and the compression panel 17. The backing 16 and compression panel 17 are pivoted toward the package 9 about the hinge 16 of the backing 16 and compression panel 17 thereby exposing the needle 101.

  FIG. 16 c shows the device 160 after the backing 16 and compression panel 17 are fully folded so that the distal ends of the backing 16 and compression panel 17 touch each other. In this position, the backing 16 supports the package 9 and the compression panel 17 partially squeezes the package 9 against the compression panel 16 to fuse the product compartment 12 with the second compartment 21 and the outlet. The seal 13 is separated and fluid communication with the fluid transfer device 14 is established. This arrangement is such that only a small portion of the contents of the fused compartment 12 'can be discharged through the fluid transfer device 14 at this location. In one embodiment, rotation of the backing 16 and compression panel 17 to this position does not separate the frangible seal and fluid communication is established between the fused compartment 12 'and the fluid transfer device. Not. In one embodiment, rotation of the backing 16 and compression panel 17 to this position only partially separates the outlet seal 13 and is therefore fluidic between the fused compartment 12 'and the fluid transfer device. Communication has not been established. In another embodiment, the outlet seal 13 is made such that the sealing force gradually decreases towards the fluid transfer device 14 and the fragile seal 13 is fluidic between the fused compartment 12 'and the fluid transfer device. Although partially separated so that communication is not established, the force required to separate the remaining portion of the outlet seal 13 is the force required to separate the first portion of the fragile seal 13. Lower.

  FIG. 16d shows the device 160 in the administration phase. The user's finger is moved to another location to squeeze the cantilever 163, thereby deflecting and further squeezing the section 12 'where the cantilever 163 is fused, thereby backing 16 and compression panel 17 Touch each other and squeeze out the contents until the fused compartment is empty. In one embodiment, the cantilever spring 163 is connected via a breakable bridge at at least one additional location near the joint 18, where the breakable bridge is a) the intent of the fused compartment 12 ′. Provides initial resistance to avoid unintentional squeezing, and b) serves as evidence that the device 160 has not been tampered with.

  The device 160 provides a mechanism to avoid unintentional administration (or explosion) by dividing the operation of the device 160 into two main stages (ie activation and administration), which includes the two You need to move your finger to another location during the stage.

  Referring now to FIG. 17, another preferred embodiment 170 is shown that includes a flow regulator in the dosing passage to prevent the contents from exploding when the device 170 is activated. FIG. 17a is an overall view of the first side of the device showing a package 9 similar to embodiment 100 of FIG. 10, where the placement of the package 11 is such that the fluid passage 13 is away from the crease line 18. It is rotated in the opposite direction to face.

  FIG. 17 c, which is an enlarged detail view of FIGS. 17 b and 17 b, is an exploded view of the apparatus 170 showing the embossed channel 170 on the surface of the first flap 16, this channel 170 being the second of the compartment 12. When sealed with a wall 74, it forms a closed flow path that acts as a dynamic flow regulator. A receptacle portion 175 at the distal end of the channel 171 communicates with the fluid passage 13 in the package 9 and receives fluid that is discharged from the package 9 when the package 9 is squeezed. The labyrinth 172 of the channel 171 communicates between the receptacle 175 of the channel 171 and the adjustment straight line portion 173. The proximal end of the channel (right side of this view) includes an opening for receiving the needle hub 102 so that flow entering the channel 171 proceeds through the channel 171 and into the needle 101. The purpose of the labyrinth 172 is to cause pressure decay that increases with increasing flow rate.

  FIG. 17d is a partial cross-sectional view along the flow channel 171 of the device 170 showing the device immediately after activation. The device 170 has already been activated and a relatively high pressure is generated in the fused compartment 12 '. This situation occurs after the device 170 is activated when the user's fingers are still exerting the backing 16 and the compression panel 17 with the relatively large force required to break the fragile seal 13. It can happen instantly. Referring again to FIG. 17d, under high pressure conditions, flow proceeds from the fused section 12 ′ through the receptacle 175 and into the labyrinth 172, where it loses considerable pressure and therefore within the adjustment stretch 173. The flow received at is substantially lower than the pressure in the fused compartment 12 '. As a result of the pressure difference between the fluid in the fused compartment 12 ′ and the flow in the adjustment stretch 173, the package is deformed, so that a portion of the additional wall 73 extends down into the adjustment line 173, The cross section of the adjustment straight line portion 173 is reduced. Distortion of the package reduces the flow rate of the released fluid, thereby preventing the explosive of the administrable fluid through the fluid transfer device 14.

  FIG. 17e shows the device 170 in the administration phase. The force applied by the finger is adjusted (from the active state to the dosing state) and the pressure in the fused compartment 12 is lowered, so that the pressure difference between the fused compartment 12 and the adjustment line 173 is reduced. The additional wall 74 retracts, reducing the flow restriction in the adjustment channel 171. The advantage of this embodiment is that an effective means to avoid the explosion of the fluid contents during activation is realized without significantly affecting the resistance to flow during administration of the contents to the patient. is there. As long as a sufficient pressure difference between the package 9 and the adjustment straight line portion 173 is generated and the second wall 74 is effectively operated so as to move into the flow path 171, the maze-like portion 172 can be eliminated. Will be apparent to those skilled in the art. In another embodiment, the elastomeric piece is contained within the flow channel. The elastomeric piece comprises a flow channel embedded in the elastomeric piece, and this arrangement causes an additional wall 73 to compress the elastomeric piece to adjust the cross-section of the channel in the elastomeric piece and thereby regulate the flow. Is for. It will be apparent to those skilled in the art that there are other arrangements for dynamically adjusting flow utilizing the pressure in the fused compartments, and that the arrangement provided in this embodiment is only an example. Let's go.

  In other embodiments, the device comprises a one-way valve to avoid refilling of the product compartment after completion of the intended first use. In other embodiments, the device comprises a time indicator that indicates the elapsed time since activation. The device can further include child protection so that it is difficult for the child to operate the device, thereby avoiding accidental administration or needle sticks.

  Referring now to FIG. 18, another preferred embodiment 180 is shown. Here, the backing 16 has a second crease line 181 located directly below the product compartment 12 and defining a second compression panel 182 in the backing 16. The package 9 is supported by a backing 16 and the second compression panel 182. This arrangement can only be manipulated so that the flap 182 pivots towards the first compartment 12 (not from a flat position away from the product compartment 12), thereby causing the first compartment 12 to move. It is intended to apply pressure. In one embodiment, the folding of the second compression panel 182 serves to squeeze the first compartment 12 to fuse the first compartment 12 to the second compartment 21 and / or additional compartments. In another embodiment, the folding of the third flap 182 serves to squeeze the first compartment 12 thereby breaking the fragile seal 13 and establishing fluid communication with the fluid transfer device 14. . In another embodiment, the first compression panel 17 is removed and the second compression panel 182 serves to dispense the product. FIG. 18a shows the device 180 in a pre-activated position. The shoulder 183 and flap 182 of the backing 19 prevent the flap 182 from pivoting downward and away from the product compartment. FIG. 18 b shows the device 180 after the flap 182 has been rotated and the first compartment 12 has merged with the second compartment 21.

  Accordingly, the present disclosure has been described with a certain degree of particularity directed to exemplary embodiments of the present disclosure. However, the present disclosure is defined by the following claims as interpreted in the light of the prior art, and thus changes to exemplary embodiments of the present disclosure without departing from the inventive concepts contained herein. It should be understood that modifications can be made.

Claims (26)

A package comprising at least one first compartment having a flexible wall portion;
A fluid transfer device;
A dosing device comprising a backing provided on the package that supports the package to facilitate squeezing the product out of the package via the fluid transfer device during dosing.   The fluid transfer device of claim 1, wherein the fluid transfer device is disposed in fluid communication with the product via a fluid passage that is hermetically spaced from the product prior to activation and is ruptured upon activation. Dosing device.   The flexible wall portion is permanently sealed along a first peripheral margin of the first partition and non-permanent along a second peripheral margin of the first partition Is sealed to define at least one first fragile outlet seal located between the first compartment and the fluid transfer device, so that the first fragile seal is broken. 2. The administration device of claim 1, wherein when in contact, the package and the fluid transfer device are in fluid communication.   The dosing device of claim 1, further comprising a compression panel for compressing at least a portion of the package against the backing.   The dosing device of claim 4, wherein the compression panel is movably joined to the backing.   5. The administration device of claim 4, wherein at least one of the backing and the compression panel is configured to match a footprint of the at least one first compartment.   The dosing device of claim 1, further comprising at least one second compartment hermetically separated from the first compartment by a fragile mixed seal.   The dosing device of claim 1, wherein at least a portion of the fluid transfer device is joined to the package via an accessory.   The dosing device of claim 2, comprising at least one of a plurality of packages, a plurality of compartments, a plurality of passages, a plurality of fluid transfer devices, and a plurality of frangible seals.   8. The administration device of claim 7, wherein a passage interconnects the first compartment and the second compartment with the fluid transfer device.   At least one of the fluid passage and the fluid transfer device is at least partially inserted between the rigid backing and the package, or is partially formed in the rigid backing, or the fragile 2. At least partially inserted between a flexible wall portion and a second wall of the package, or at least partially integrated into at least one of the package and the backing. The administration device according to 1.   The administration device of claim 1, further comprising a plurality of compartments and at least one mixing seal disposed between the plurality of compartments.   The administration device according to claim 1, wherein the package is formed from a plurality of walls and comprises the plurality of walls.   The administration device of claim 1, wherein the backing defines a wall of the at least one first compartment.   The dosing device of claim 1, further comprising a flow control device disposed at least partially between the walls of the package, between the package and the backing, or within the backing.   The apparatus further comprises a flow regulator formed at least partially between the backing and the package, wherein product pressure in the package deforms the package to restrict flow through the fluid passage. The administration device according to 1.   17. A dosing device according to claim 16, wherein the flow regulator is an embossed channel having a labyrinth.   The fluid transfer device is selected from the group consisting of at least one of a needle, a mini needle, a microneedle, a connector, a fixture, a tube, a dropper, a topical applicator, a spray head, and a jet injector. Item 2. The administration device according to Item 1.   The dosing device of claim 4, wherein the package is at least partially supported by the compression panel.   The dosing device of claim 4, wherein the compression panel protects at least a portion of the fluid transfer device prior to use.   The dosing device of claim 1, further comprising a cover removably joined to the backing to seal at least a portion of the fluid transfer device.   The administration device according to claim 1, comprising the resealable package.   The administration device of claim 1, wherein the fluid transfer device is disabled after use.   The dosing device of claim 4, wherein the compression panel disables the fluid transfer device after use. (A) a package comprising at least one first compartment containing a product, wherein the first compartment is a flexible wall portion;
A fluid transfer device;
Providing a device comprising a backing;
(B) compressing the package against the backing and dispensing the product from the fluid transfer device;
A method comprising:   26. The method of claim 25, wherein the device further comprises a compression panel for implementing (b), and the method further comprises disabling the fluid transfer device at the compression panel.

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