Applicator device and methods of use and making thereof

Abstract

An applicator device is disclosed. The applicator device includes a first body portion having a dispensing tip defining a flow passage. The first body portion includes a dispensing chamber formed of a deformable material in fluid communication with the flow passage for dispensing a fluid and an ampoule receiving chamber in fluid communication with the dispensing chamber for receiving an ampoule therein. A closure is releasably coupled to the dispensing tip to seal the flow passage. A second body portion is configured to be coupled to the first body portion. At least a portion of the second body portion extends over the ampoule receiving chamber. The second body portion includes a resilient member configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use. Methods of making and use are also disclosed.

Description

APPLICATOR DEVICE AND METHODS OF USE AND MAKING THEREOFPRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 633,924, filed April 15, 2024, which is hereby incorporated by reference in its entirety.FIELD

[0002] The present technology relates to an applicator device, and more specifically to an applicator device for dispensing drugs or other fluids packaged in ampoules that can be crushed to release a fluid therein.BACKGROUND

[0003] Ampoules are often used to package and store materials / products in fluid form in relatively small quantities, e.g., about 0.1 ml to about 2.0 ml. Ampoules are often used, for example, to store chemical and / or medicinal products.

[0004] Ampoules are typically made of glass or plastic and define an internal cavity that is hermetically sealed from the environment by the ampoule material. A benefit of ampoules is that they provide tamper-resistant packaging and the ability to immediately detect whether the package has been compromised. Ampoules are often used to protect sensitive formulations from environmental exposure. Additionally, ampoules are often used to prevent volatile chemistries from evaporating under standard operating room conditions.

[0005] The ampoule is formed as a containment vessel for the fluid therein, and is initially fabricated with an open end for receiving a fluid to fill the ampoule. After the ampoule is filled, the open end is heat-formed to hermetically seal the fluid therein. The fluid then remains stored in the ampoule until it is used for its intended purpose. Generally, during use, the ampoule is ruptured to release the fluid contained therein.

[0006] Various devices, many including filters, are used with crushable ampoules to protect the user from fragments from the broken ampoule while still permitting the liquid to be used either for topical application or creation of a vapor, such as smelling salts.

[0007] Many devices used with crushable ampoules store the ampoule in a chamber that is squeezed by the user until the ampoule is crushed. The user then subsequently squeezes this same ampoule chamber to dispense the fluid from the device. In this current configuration, there are several challenges experienced by the user. First, the dispensing action requires squeezing a tube and shards of glass existing within the tube, which requires additional force by the user andalso exposes the user to potential fractures of the glass shards penetrating the tube and causing lacerations. Second, in this device configuration, fluid becomes stuck within portions of the ampoule that have not fully shattered. This results in high residual volumes of fluid that are unable to be dispensed. For applications, wherein the fluid is a medicament, this can present issues, since the full dose will be unavailable due to this residual volume retained within the ampoule chamber.

[0008] Applicator devices are known for dispensing a medicament. However, such devices are subject to potential contamination or tampering. As the medicament is applied to the skin, it is best practice to ensure that the drug being introduced to the dermal layer is sterile. To maintain this sterility, it is imperative that all components that come in contact with the drug or the applicator are also maintained in sterile form. Some drugs are able to withstand terminal sterilization, wherein the finished drug and device combinations are placed in a sterilization chamber, such as an autoclave, an ethylene oxide chamber, or a gamma irradiation chamber. Within these chambers, the device and drug are subject to conditions that can are known to destroy pathogens.

[0009] Some drugs and biologies are unable to withstand terminal sterilization. For these drugs, an aseptic process may be required for any component that comes in direct contact with the drug. This type of aseptic manufacturing process is a significant manufacturing challenge. Aseptic manufacturing environments typically require very tight particulate control and restrict the presence of humans due to contamination risks. These aseptic controls often require extensive automation equipment to assemble these applicator while introducing drug at the appropriate stages, while maintaining sterility throughout this process. The customized equipment and manufacturing controls are a significant roadblock in the effective scale-up and commercialization of applicators.

[0010] This disclosure is directed to overcoming these and other deficiencies in the art.SUMMARY

[0011] One aspect of the present technology relates to an applicator device. The applicator device includes a first body portion having a proximal end and a distal end. The distal end terminates in a dispensing tip defining a flow passage. The first body portion includes a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device. The dispensing chamber is formed of a deformable material. An ampoule receiving chamber is in fluid communication with the dispensing chamber. The ampoule receiving chamber includes a cavity for receiving an ampouletherein. A closure is releasably coupled to the dispensing tip to seal the flow passage. A second body portion is configured to be coupled to the first body portion. At least a portion of the second body portion extends over the ampoule receiving chamber. The second body portion includes a resilient member configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

[0012] Another aspect of the present technology relates to a method of using the applicator device of the present technology. The method includes applying a force to the resilient member to move the resilient member to apply a force to the ampoule receiving chamber to rupture the ampoule located within the cavity to release a fluid stored in the ampoule. A force is applied to opposing sides of the dispensing chamber to force air to exit the dispensing chamber. The closure prevents air from going through the dispensing tip. The force applied to the opposing sides of the dispensing chamber is released to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber. The closure is removed from dispensing tip to open the flow passage.

[0013] A further aspect of the present technology relates to a method of making an applicator device. The method includes providing a first body portion having a proximal end and a distal end, the distal end terminating in a dispensing tip defining a flow passage. The first body portion includes a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device. The dispensing chamber is formed of a deformable material. An ampoule receiving chamber is in fluid communication with the dispensing chamber. The ampoule receiving chamber includes a cavity for receiving an ampoule therein. A closure is releasably coupled to the dispensing tip to seal the flow passage. A second body portion is coupled to the first body portion. At least a portion of the second body portion extends over the ampoule receiving chamber. The second body portion includes a resilient member located on the second body portion. The resilient member is configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

[0014] The present technology advantageously provides an applicator device for topical application of a medicament, for example, to a user’s skin. The applicator device provides for controlled delivery of the fluid from a breakable ampoule that stores and protects the fluid prior to usage. Furthermore, the ampoule serves as a primary container for storage of the fluid, which significantly simplifies the manufacturing and sterilization processes of the applicator device in comparison to existing manufacturing processes.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 A is a front view of an exemplary applicator device of the present technology.

[0016] FIG. IB is a side view of the exemplary applicator device shown in FIG. 1 A.

[0017] FIG. 1C is a side cross-sectional view of the exemplary applicator device shown in FIG. 1A.

[0018] FIG. ID is a side-cross-sectional view of the exemplary applicator device shown in FIG. 1 A with the closure removed.

[0019] FIG. IE is an exploded perspective view of the exemplary applicator device shown in FIG. 1 A.

[0020] FIG. 2A is a front view of the exemplary applicator device having another exemplary closure device.

[0021] FIG. 2B is a perspective view of the first body portion of the exemplary applicator device shown in FIG. 2A.

[0022] FIG. 3 A is a side schematic view of an exemplary application device having an entry port device for receiving an ampoule therein after assembly of the device and to seal the device after insertion.

[0023] FIG. 3B is a side schematic view of another exemplary applicator device having an entry port device for receiving an ampoule therein after assembly of the device and to seal the device after insertion.

[0024] FIG. 4A is a side cross-sectional view of an exemplary applicator of the present technology prior in a storage state prior to initiating fluid delivery.

[0025] FIG. 4B is an enhanced view of a portion the exemplary applicator shown in FIG. 4A.

[0026] FIG. 5A is a side cross-sectional view of an exemplary applicator device of the present technology during rupture of the ampoule stored therein.

[0027] FIG. 5B is an enhanced view of a portion the exemplary applicator device shown in FIG. 5 A.

[0028] FIG. 6A is a side cross-sectional view of an exemplary applicator device of the present technology after rupture of the ampoule stored therein during creation of a vacuum state.

[0029] FIG. 6B is an enhanced view of a portion the exemplary applicator device shown in FIG. 6A.

[0030] FIG. 7A is a side cross-sectional view of an exemplary applicator device of the present technology after rupture of the ampoule stored therein during dispense-ready state.

[0031] FIG. 7B is an enhanced view of a portion the exemplary applicator device shown in FIG. 7A.

[0032] FIG. 8A is a side cross-sectional view of an exemplary applicator device of the present technology after rupture of the ampoule stored therein during dispense-ready state, with the dispensing chamber including a powder configured to interact with a fluid therein.

[0033] FIG. 8B is an enhanced view of a portion the exemplary applicator device shown in FIG. 8A.DETAILED DESCRIPTION

[0034] The present technology relates to an applicator device, and more specifically to an applicator device for dispensing drugs or other fluids packaged in ampoules that can be crushed to release a fluid therein.

[0035] One aspect of the present technology relates to an applicator device. The applicator device includes a first body portion having a proximal end and a distal end. The distal end terminates in a dispensing tip defining a flow passage. The first body portion includes a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device. The dispensing chamber is formed of a deformable material. An ampoule receiving chamber is in fluid communication with the dispensing chamber. The ampoule receiving chamber includes a cavity for receiving an ampoule therein. A closure is releasably coupled to the dispensing tip to seal the flow passage. A second body portion is configured to be coupled to the first body portion. At least a portion of the second body portion extends over the ampoule receiving chamber. The second body portion includes a resilient member configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

[0036] FIGS. 1 A-1E illustrate an example of an applicator device 10 of the present technology. The applicator device 10 includes a first body portion 12 having a dispensing tip 14, a dispensing chamber 16, and an ampoule receiving chamber 18. The applicator device further includes a first filter 20, a closure device 22, a second body portion 24, and a resilient member 26, although the applicator device 10 can include other types and / or numbers of elements in other combinations, including the additional examples described herein. In some examples, the applicator device 10 may include an ampoule 28 pre-loaded therein. The applicator device 10 advantageously provides a device that can be used to precisely dispense a fluid stored in a breakable ampoule. The applicator 10 can be used to rupture the ampoule, filter particles from the broken ampoule, and dispense the fluid. The applicator device 10 can be used in a similarfashion to a writing implement to allow for precise application therefrom. The applicator device 10 further allows for a controlled rate of delivery of the fluid to a specific location, for example, on the surface of the user’s skin.

[0037] The first body portion 12 extends between a distal end 30 and a proximal end 32. The distal end 30 terminates in the dispensing tip 14 defining a flow passage 34 for dispensing a fluid from the applicator device 10. The dispensing tip 14 provides an opening 38 in fluid communication with the flow passage 34 that is shaped to allow for precise distribution of a fluid emitted therefrom, for example, to the user’s skin. For example, the dispensing tip 14 may be shaped similar to the tip of a pen or other writing instrument to allow for the precise application of a fluid dispensed therefrom.

[0038] The first body portion 12 further includes the dispensing chamber 16 and the ampoule receiving chamber 18. In some examples, the first body portion 12 has a unitary construction, although it is to be understood that one or more portions of the first body portion 12 could be separately constructed and coupled to one another. The dispensing chamber 16 is in fluid communication with the flow passage 34 of the dispensing tip 14, as illustrated in FIGS. 1C and ID. The dispensing chamber 16 is formed of a deformable material, such as a thin-walled elastomeric material, such that an outer wall 38 of the dispensing chamber 16 is pliable and can be manually deformed by a user, such as through applying a pressure to opposing sides of the dispensing chamber 16 to squeeze the dispensing chamber, for example, through the user’s thumb, index, and / or middle finger while holding the applicator device 10 in a similar fashion to a writing instrument.

[0039] The first body portion 12 further includes the ampoule receiving chamber 18 extending from and in fluid communication with the dispensing chamber 16. The ampoule receiving chamber 18 has an internal cavity 40 configured to receive an ampoule, such as the ampoule 28 shown in FIG. IE, therein. The ampoule receiving chamber 18 is formed of a deformable material, such as a deformable thin-walled elastomeric material, by way of example only. In some examples, the ampoule receiving chamber 18 is formed of the same material as the dispensing chamber 16 as a unitary construction. In this manner, an outer wall 42 of the ampoule receiving chamber 18 may be deformed under manual pressure during use, such as pressure applied by a user’s finger to the resilient member 26, as described in further detail below. The ampoule receiving chamber 18 includes an opening 44 that allows for insertion of the ampoule, such as ampoule 28 shown in FIG. IE, into the cavity 40.

[0040] The first filter 20 is configured to be positioned within the first body portion 12 between the dispensing chamber 16 and the ampoule receiving chamber 18. The first filter 20 is configured to prevent particulate from moving from the ampoule receiving chamber 18 to thedispensing chamber 16 when the ampoule is ruptured. For example, the first filter 20 can be a porous membrane that allows fluid to flow through to move from the ampoule receiving chamber 18 to the dispensing chamber 16. For illustration purposes only, the first filter 20 provides a plurality of flow channels 46 (i.e., areas in the porous membrane that allow fluid to pass through) such that the first filter 20 allows fluid to flow from the ampoule receiving chamber 18 into the dispensing chamber 16 while stopping the passage of glass from the ruptured ampoule passing through, during use.

[0041] In some examples, the applicator device 10 further includes a closure device 22 that is releasably coupled to the dispensing tip 14 to seal the flow passage 34 prior to dispensing the fluid. In the example illustrated in FIGS. 1 A-1E, the closure device 22 is a cap configured to be coupled to the end of the dispensing tip 14. Closure device 22, such as the cap illustrated in FIGS. 1 A, IB, 1C, and IE, and dispensing tip 14 can include one or more features that allow for the closure device 22 to be releasably coupled to the dispensing tip 14. In one example, the dispensing tip 14 and the closure device 22, such as the cap, are configured to be coupled together through a snap-fit engagement, such as through complementary ribs and grooves located on the mating surfaces dispensing tip 14 and the closure device 22, respectively. In another example, the closure device 22, such as the cap shown in FIGS. 1 A, IB, 1C, and IE, comprises internal threads that are designed to provide a screw-fit engagement with corresponding external threads located on the dispensing tip 14. It is to be understood that closure device 22 can be removably coupled to the dispensing tip 14 to provide a seal for the dispensing tip 14 in other manners.

[0042] For example, FIGS. 2A and 2B illustrate an alternative closure device 122 that is configured as a tab integrally formed with the dispensing tip 14 of the first body portion 12. In this example, the dispensing tip 14 further comprises a releasable attachment portion 50 that is integrally formed with the first body portion 12 and is configured to rupture in response to a force applied to the closure device 122, such as the tab shown in FIG. 2, to allow for removal of the closure device 122 from the dispensing tip 14. For example, the releasable attachment portion 50 can be a thin-walled, fragile portion of the closure device 122 that is integrally formed with the first body portion 14 and is adapted to rupture in response to an applied force, such as twisting the closure device 122, to allow for removal of the closure device 122 (e.g., a tab) from the dispensing tip 14. It is to be understood that closure devices 22 and 122 are exemplary and that other configurations of closure devices can be used to provide a seal for the flow passage 34 of the dispensing tip 14.

[0043] Referring again to FIGS. 1 A-1E, the exemplary applicator device 10 in this example further includes the second body portion 24. Second body portion 24 is configured tobe coupled to the first body portion 12. In some examples, as shown for example in FIG. 1C, at least a portion of the second body portion 24 extends over the ampoule receiving chamber 18. The second body portion 24 is configured to be coupled to the first body portion 14 to enclose the cavity 40 of the ampoule receiving chamber 18 of the first body portion 12. The second body portion 24 and the first body portion 12 can be mated together using any technique known in the art, such as a snap-fit engagement by way of example only. In some examples, such as described with respect to FIGS. 3 A and 3B below, the first body portion 12 and the second body portion can be integrally formed together.

[0044] In this example, the second body portion 24 includes the resilient member 26, which is located on the second body portion 24 in the at least a portion thereof that overlaps the first body portion 12. The resilient member 26 is formed of a pliable material and is configured to be moveable to apply a force to the ampoule receiving chamber 18 to rupture the ampoule 28 when located within the cavity 40 during use. For example, FIGS. 5A and 5B, described in further detail below, illustrate the resilient member 26 in a deformed state resulting from manual pressure applied thereto.

[0045] Referring again to FIGS. 1 A-1E, in this example the resilient member 26 is part of the second body portion 24. However, it is to be understood that the resilient member 26 could be a separate component in other examples. In some examples, the resilient member 26 includes an optional projection (not shown) extending from a surface of the resilient member 26 toward the second body portion 24 and having a contact tip (not shown) that contacts the outer wall 42 of ampoule receiving chamber 18 to assist in breaking the ampoule 28. The contact tip can be shaped to have a point having reduced surface area to assist in cracking the ampule 28. In this manner, the contact tip concentrates the force applied on the resilient member 26 to a point to reduce the manual force required to break the ampoule 28. For example, the contact tip can be positioned to contact the ampoule 28 in a location proximate to the first filter 20.

[0046] In some examples, as shown in FIG. IE, the second body portion 24 includes a vent 52 that allows air to escape from the ampoule receiving chamber 18 during use, as further described below. However, it is to be understood that the applicator device 10 could operate in a similar manner as described below without the use of vent 52. In some examples, such as illustrated in FIGS. 1 A-1E, in which the second body portion 24 includes the vent 52, a second filter 54 is utilized. The second filter 54 is configured to be positioned in the ampoule receiving chamber 18 or the second body portion 24 to be positioned adjacent to the vent 52. In this example, the second filter 54 is formed of a hydrophobic material that allows air to flow through the vent 52 but prevents fluid from leaking out of the ampoule receiving chamber 18 through the vent 52 of the second body portion 24.

[0047] In some examples, as shown in FIGS. 3A and 3B, for example, the second body portion 24 further includes an opening 55 and an entry port device 56 located proximate to the opening 55 to allow for the ampoule 28 to be inserted into the cavity 40 of the ampoule receiving chamber 18 and to provide a seal for the opening 55 of the second body portion 24 after insertion. Although the entry port device 56 is described and illustrated as part of the second body portion 24, it is to be understood that in other examples the entry port device 56 could be part of the ampoule receiving chamber 18.

[0048] The use of the entry port device 56 allows for the ampoule 28 to be inserted at the final stage of assembly. This allows for the applicator device 10 to be fully assembled and sterilized independent of the fluid-filled ampoule 28. This configuration allows for a factory to install the ampoule 28 at the last stage of assembly. Alternatively, this configuration allows for a user to install the ampoule 28 into the applicator device 10 at the point-of-care.

[0049] FIG. 3 A illustrates one example of the second body portion 24 of the applicator device 10 having the entry port device 56 configured as a duck-billed valve for one-way insertion of the ampoule 28. FIG. 3B illustrates another example of the applicator device 10 with the second body portion 24 having the entry port device 56 that includes a living hinge 58, i.e., a bendable section of the second body portion 24 itself. In this example, the entry port device 56 further includes a cap 60 that is selectively inserted into the opening 55 of the second body portion 24 to close the cavity 40 of the ampoule receiving chamber 18 by operation of the living hinge 58. The cap 60 further includes tabs 62 that are insertable in corresponding openings 64 on an internal surface of the second body portion 24 to seal the ampoule receiving chamber 18 after insertion of the ampoule 28. This advantageously allows insertion of the ampoule 28 and sealing of the opening 55 of the cavity 40 after assembly of the applicator 10, i.e., as a later manufacturing step or at the point-of-care. In some examples, the cap 60 could be employed as a separate element, i.e., without the living hinge 58. In either example, the cap 60 could include the vent 52 as shown in FIG. IE, for example, although as described above, it is to be understood that the applicator device 10 could operate in a similar manner as described below without the use of vent 52.

[0050] In some examples, the applicator device 10 may further include the ampoule 28 pre-loaded therein. The ampoule 28 can be any breakable ampoule 28 device known in the art. The ampoule 28 includes a fluid or powder stored therein. The ampoule 28 can be utilized with any fluids or powders known in the art. In some examples, the fluid comprises a medicament for application on a user’s skin. In other examples, the powder comprises a lyophilized medicament for that may be absorbed into a user’s skin and reconstituted. In some examples, the applicator device 10 may include the ampoule 28, containing a fluid, and the dispensing chamber 18,containing a powder. This fluid may be a diluent, which is used to reconstitute the powder, which may be a lyophilized medicament.

[0051] Another aspect of the present technology relates to a method of making an applicator device. The method includes providing a first body portion having a proximal end and a distal end, the distal end terminating in a dispensing tip defining a flow passage. The first body portion includes a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device. The dispensing chamber is formed of a deformable material. An ampoule receiving chamber is in fluid communication with the dispensing chamber. The ampoule receiving chamber includes a cavity for receiving an ampoule therein. A closure is releasably coupled to the dispensing tip to seal the flow passage. A second body portion is coupled to the first body portion. At least a portion of the second body portion extends over the ampoule receiving chamber. The second body portion includes a resilient member located on the second body portion. The resilient member is configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

[0052] A method of making the applicator device 10 will now be described. It is to be understood that one or more steps in the method could be completed in different orders based on different manufacturing procedures. Referring specifically to FIG. IE, which shows an exploded view of the applicator device 10, first, the first body portion 12 including the dispensing chamber 16 and the ampoule receiving chamber 18 is provided. First filter 20 is inserted into the cavity 40 of the ampoule receiving chamber 18 to be located between the dispensing chamber 16 and the ampoule receiving chamber 18 to prevent particulates from entering the dispensing chamber 16 or the dispensing tip 14, as described in further detail below. The ampoule 28 having a fluid (not shown in FIG. IE), such as a medicament, stored therein can then be inserted into the cavity 40 of the ampoule receiving chamber 18 for storage. In some examples, as shown in FIGS. 3 A and 3B described above, the second body portion 24 includes the entry port device 56 to allow for insertion of the ampoule 28 after assembly of the applicator device 10, as described below, and sealing of the applicator device 10. This advantageously allows the ampoule 28 to be inserted at different points in the manufacturing process. Alternatively, the ampoule 28 can be provided separately and installed by a different manufacturer or a user at the point-of-care. The ampoule 28 can be inserted through opening 55 into the cavity 40 and the entry port device 56 seals the applicator device 10.

[0053] Next, the closure device 22 is releasably coupled to the dispensing tip 14 to seal the opening 36 of the flow passage 34. The second body portion 24 is coupled to the first body portion 12. In some examples, at least a portion of the second body portion 24 extends over theampoule receiving chamber 18 of the first body portion 12. The resilient member 26 is provided to be moveable to apply a force to the ampoule receiving chamber 18 to rupture the ampoule 28 when located within the cavity 40 during use. In some examples, the resilient member 26 is integral to the second body portion 24, although it is to be understood that the resilient member 26 could be a separate component. In some examples, the second body portion 24 includes the vent 52, as shown in FIG. IE. The method can further include positioning the second filter 54 in the second body portion 24 adjacent to the vent 52 prior to coupling to the first body portion 12.

[0054] Another aspect of the present technology relates to a method of using the applicator device of the present technology. The method includes applying a force to the resilient member to move the resilient member to apply a force to the ampoule receiving chamber to rupture the ampoule located within the cavity to release a fluid stored in the ampoule. A force is applied to opposing sides of the dispensing chamber to force air to exit the dispensing chamber. The closure prevents air from going through the dispensing tip. The force applied to the opposing sides of the dispensing chamber is released to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber. The closure is removed from dispensing tip to open the flow passage.

[0055] An exemplary operation of the exemplary applicator device 10 of the present technology will now be described with respect to FIGS. 1 A-7B. FIGS. 4 A and 4B illustrate the applicator device 10 in a storage state with a fluid or power 66 stored therein. In order to operate the applicator device 10, the user applies a manual force to the resilient member 26 to move the resilient member 26 to apply a force to the outer wall 42 of the ampoule receiving chamber 18, as shown for example in FIGS. 5 A and 5B. The user can manually apply force using a thumb or finger, by way of example. As manual pressure is applied to the resilient member 26, the resilient member 26 deflects inwardly toward the ampoule receiving chamber 18. The manual pressure further deforms the outer wall 42 of the ampoule receiving chamber 18 to apply a force to the ampoule 28 to rupture the ampoule 28, which is located within the cavity 40 of the ampoule receiving chamber 18. The force applied must be sufficiently strong to rupture the ampoule 28.

[0056] As shown in FIGS. 5A and 5B, cracking the ampoule 28 leads to eventual rupture, which releases the fluid 66 stored therein into the cavity 40 of ampoule receiving chamber 18. Next, the user applies a manual force, such as a squeezing force, to opposing sides of the outer wall 38 of the dispensing chamber 16, as shown in FIGS. 6A and 6B to force air to exit the dispensing chamber 16. For example, the user may squeeze the opposing sides of the outer wall 38 of the dispensing chamber 16 while holding the applicator device 10 in a similar fashion to a writing utensil. The closure device 22 prevents air from going through the dispensing tip 14 as aresult of the force applied to the dispensing chamber 16. In some examples, second body portion 24 includes a vent, such as vent 52 shown in FIG. IE, for example. In this example, air is pushed through the vent 52 to exit the applicator device 10. However, it is to be understood that the applicator device 10 can operate in a similar manner without the use of a vent to evacuate air due to the compression of air that occurs within the applicator device 10.

[0057] Next, the user releases the manual force applied to the opposing sides of the outer wall 38 of the dispensing chamber 16, which allows the opposing sides of the outer wall 38 to deflect back to their original position as shown, for example, in FIGS. 7A and 7B, which show the ampoule 28 fully ruptured. Releasing the force applied to the opposing sides of the outer wall 38 of the dispensing chamber 16 creates a negative pressure environment within the applicator 10 that causes the fluid 66 to flow from the cavity 40 of the ampoule receiving chamber 18 to the dispensing chamber 16 and through the flow passage 34 of the dispensing tip 14 to the opening 36 of the dispensing tip 14 to dispense the fluid 66 to the skin of the user, by way of example. The first filter 20 located between the dispensing chamber 16 and the ampoule receiving chamber 18 allows the fluid 66 to flow from the ampoule receiving chamber 18 to the dispensing chamber 16, while preventing any particulate from the broken ampoule 28 from entering the dispensing chamber 16 or the dispensing tip 14. In some examples, as the fluid 66 flows to the dispensing chamber 16, air is pulled into the ampoule receiving chamber 18 through the vent 52, as shown in FIG. IE.

[0058] Once the fluid 66 enters the dispensing chamber 16, the user can once again apply a squeezing force, in a similar fashion as discussed above, to opposing sides of the outer wall 38 of the dispensing chamber 16 to dispense the fluid through the dispensing tip for application.

[0059] In another example, as shown in FIGS. 8A and 8B, the ampoule 28 contains a fluid, and the dispensing chamber 18, contains a powder 68. In this example, the fluid 66 may be a diluent, which is used to reconstitute the powder 68 when the two interact in the dispensing chamber 16. In this example, the powder 68 may be a lyophilized medicament.

[0060] Accordingly, the present technology provides an applicator device that can be used to apply a fluid or powder, such as a medicament, a user’s skin in a precise, controlled application. The fluid can be stored in a breakable ampoule device that stores the fluid therein prior to usage in a tamper-proof manner. The ampoule is easily breakable through manual force and the device advantageously filters particulate from the broken ampoule to prevent delivery of the particulate to the user’s skin during fluid delivery.

[0061] Although preferred embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions, and the like can be made without departing from the spirit of the invention andthese are therefore considered to be within the scope of the invention as defined in the claims which follow.

Claims

What is claimed is:

1. An applicator device comprising: a first body portion having a proximal end and a distal end, the distal end terminating in a dispensing tip defining a flow passage, the first body portion comprising: a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device, the dispensing chamber formed of a deformable material; and an ampoule receiving chamber in fluid communication with the dispensing chamber, the ampoule receiving chamber comprising a cavity for receiving an ampoule therein; a closure releasably coupled to the dispensing tip to seal the flow passage; and a second body portion configured to be coupled to the first body portion, wherein at least a portion of the second body portion extends over the ampoule receiving chamber, the second body portion comprising a resilient member configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

2. The applicator device of claim 1, wherein the second body portion further comprises a vent configured to allow air to pass out of the second body portion3. The applicator device of any of the preceding claims further comprising: a first filter configured to be positioned within the body between the dispensing chamber and the ampoule receiving chamber.

4. The applicator device of claim 3, wherein the first filter is configured to prevent particulate from moving from the ampoule receiving chamber to the dispensing chamber.

5. The applicator device of claim 2 further comprising: a second filter configured to be positioned in the ampoule receiving chamber adjacent to the vent of the second body portion when the second body portion is coupled to the first body portion.

6. The applicator device of claim 5, wherein the second filter is formed of a hydrophobic material.

7. The applicator device of any of the preceding claims, wherein the closure is a cap configured to be coupled to the end of the dispensing tip.

8. The applicator device of claim 7, wherein the end of the dispensing tip and the cap are configured to be coupled through a snap-fit engagement.

9. The applicator device of claim 7, wherein the cap comprises internal threads and the dispensing tip comprises external threads, such that the dispensing tip and the cap are configured to be coupled through a screw-fit engagement.

10. The applicator device of any of the preceding claims, wherein the closure comprises a tab integrally formed with the dispensing tip of the first body portion, the dispensing tip further comprising a releasable attachment portion configured to rupture in response to a force applied to the tab to allow removal of the tab from the dispensing tip.

11. The applicator device of any of the preceding claims, wherein the ampoule receiving chamber is formed of a deformable material.

12. The applicator device of claim 11, wherein the ampoule receiving chamber and the dispensing chamber are formed from the same material.

13. The applicator device of any of the preceding claims further comprising: the ampoule having a fluid stored therein.

14. The applicator device of claim 13, wherein the fluid comprises a medicament.

15. The applicator device of claim 13 further comprising a powder located in the dispensing chamber configured to interact with the fluid when released from the ampoule and into the dispensing chamber.

16. The applicator device of claim 15, wherein the powder comprises a lyophilized medicament.

17. The application device of any of the preceding claims, wherein the second body portion further comprises an entry port device configured to allow an ampoule to be inserted in the ampoule receiving chamber and provide a seal for the cavity.

18. The fluid dispensing patch of claim 17, wherein the entry port device comprises one of a duck-bill valve or a cap coupled to the second body portion through a living hinge.

19. A method of using the applicator device of any of the preceding claims, the method comprising: applying a force to the resilient member to move the resilient member to apply a force to the ampoule receiving chamber to rupture the ampoule located within the cavity to release a fluid stored in the ampoule; applying a force to opposing sides of the dispensing chamber to force air to exit the dispensing chamber, wherein the closure prevents air from going through the dispensing tip; releasing the force applied to the opposing sides of the dispensing chamber to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber; and removing the closure from the dispensing tip to open the flow passage.

20. The method of claim 19 further comprising: applying a force to the opposing sides of the dispensing chamber to dispense the fluid located therein through the dispensing tip.

21. The method of claim 19 further comprising: applying the fluid dispensed through the dispensing tip to a bodily tissue.

22. The method of claim any one of claims 19 through claim 21, wherein the fluid comprises a medicament.

23. A method of making an applicator device, the method comprising: providing a first body portion having a proximal end and a distal end, the distal end terminating in a dispensing tip defining a flow passage, the first body portion comprising:a dispensing chamber in fluid communication with the flow passage of the dispensing tip for dispensing a fluid from the applicator device, the dispensing chamber formed of a deformable material; and an ampoule receiving chamber in fluid communication with the dispensing chamber, the ampoule receiving chamber comprising a cavity for receiving an ampoule therein; releasably coupling a closure to the dispensing tip to seal the flow passage; and coupling a second body portion to the first body portion, wherein the at least a portion of the second body portion extends over the ampoule receiving chamber, the second body portion comprising a resilient member located on the second body portion, the resilient member configured to be moveable to apply a force to the ampoule receiving chamber to rupture the ampoule when located within the cavity during use.

24. The method of claim 23, wherein the second body portion further comprises a vent configured to allow air to pass out of the second body portion during use.

25. The method of claim 23 or claim 24 further comprising: inserting the ampoule comprising a medicament located therein through an opening in the second body portion into the cavity of the ampoule receiving chamber.

26. The method of any one of claims 23 through claim 25 further comprising: positioning a first filter within the first body portion between the dispensing chamber and the ampoule receiving chamber.

27. The method of any one of claims 24 further comprising: positioning a second filter in the second body portion adjacent to the vent.

28. The method of any one of claims 23 through claim 27, wherein the second body portion further comprises an entry port device located proximate the opening and configured to allow an ampoule to be inserted therein and seal the cavity after insertion, the method further comprising: inserting the ampoule comprising the medicament in into the cavity of the ampoule receiving chamber through the opening.

29. The method of claim 28, wherein the entry port device comprises a duck-bill valve.

30. The method of claim 28, wherein the entry port device comprises a cap coupled to the second body portion through a living hinge, the method further comprising: inserting the cap in the opening of the cavity through operation of the living hinge to seal the opening of the cavity after insertion of the ampoule therein.

31. The method of any one of claims 23 through claim 30 further comprising: locating a powder in the dispensing chamber, the powder configured to interact with the fluid when released from the ampoule and into the dispensing chamber.

32. The method of claim 31, wherein the powder comprises a lyophilized medicament.

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