Fluid dispensing patch device and methods of use and making thereof priority

Abstract

A fluid dispensing patch device is disclosed. The fluid dispensing patch device includes a patch body. A first housing member is located the patch body and includes a dispensing cavity and an elongate channel. An internal housing member is configured to be coupled to the first housing member. The internal housing member includes a dispensing chamber and an ampoule receiving chamber that extends from and is in fluid communication with the dispensing chamber. The ampoule receiving chamber has a cavity configured to receive an ampoule therein and is formed of a deformable material. A second housing member is configured to be coupled to the first housing member to retain the internal housing member. A 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. Methods of making and use are also disclosed.

Description

FLUID DISPENSING PATCH DEVICE AND METHODS OF USE AND MAKING THEREOFPRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 633,925, filed April 15, 2024, which is hereby incorporated by reference in its entirety.FIELD

[0002] The present technology relates to a fluid dispensing patch device, and more specifically to a micro-needle array patch 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.

[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] Patch devices, such as on-body infusion pumps have been used to dispense medications to precise locations for controlled periods of time. For instance, oncology medication often requires extended infusion durations to prevent these cytotoxic chemistries from entering the body too rapidly. Furthermore, some vaccines and pain medications, experience improved drug uptake when delivered over extended periods of time.

[0008] Microneedle array patch devices are a subset of patch devices. They aim to reduce pain associated with the insertion of standard needle gauges, which are used on conventional patch-based devices, such as on-body infusion pumps. The microneedle array patch devices contain needles typically with height ranges between 100 to 1500 pm, base widths of 50 to 250 pm and tip diameters of 1 to 30 pm. The size range of these microneedles is generally below the level that triggers pain intensity in humans. Since microneedle array patches may reduce pain associated with parental drug delivery, this may improve medication adherence, which is a widely known problem in the industry.

[0009] One of the challenges with microneedle array patch devices is the packaging of drug within these delivery devices. Generally, it is best practice to ensure that the drug entering the dermal layer is sterile. To maintain this sterility, it is imperative that all components that come in contact with the drug are also maintained in sterile form. This is a particular challenge for microneedle array patches because the drug is introduced directly into reservoirs connected to the needles. Alternatively, microneedles can be fabricated through lithographic fabrication methods that use binding agents to form drugs into needle shapes. In any of these scenarios, it is a significant manufacturing challenge to aseptically combine drug with the components in a microneedle array patch. 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 microneedle array patches 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 microneedle array patch devices.

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

[0011] One aspect of the present technology relates to a fluid dispensing patch device. The fluid dispensing patch device includes a patch body having a first side and a second side, the patch body having an opening therein. A first housing member is located on the first side of the patch body. The first housing member includes a dispensing cavity aligned with the opening of the patch body. An elongate channel extends from the dispensing cavity. An internal housing member is configured to be coupled to the first housing member. The internal housing member includes a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body. An ampoule receiving chamber extends from and isin fluid communication with the dispensing chamber. The ampoule receiving chamber has a cavity configured to receive an ampoule therein. The ampoule receiving chamber is formed of a deformable material. A second housing member is configured to be coupled to the first housing member to retain the internal housing member within the first housing member and the second housing member. At least a portion of the second housing member extends over the ampoule receiving chamber. A 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.

[0012] Another aspect of the present technology relates to a method of using the fluid dispensing patch device of the present technology. The method includes applying the patch body to the skin of a user. A force is applied 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. The force causes air to evacuate the dispensing chamber. The force applied to the resilient member is released to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber toward the opening of the patch body to dispense the fluid located therein.

[0013] A further aspect of the present technology relates to a method of making a fluid dispensing patch device. The method includes providing a patch body having a first side and a second side, the patch body having an opening therein. A first housing member is located on the first side of the patch body. The first housing member includes a dispensing cavity aligned with the opening of the patch body. An elongate channel extends from the dispensing cavity. An internal housing member is coupled to the first housing member. The internal housing member includes a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body. An ampoule receiving chamber extends from and is in fluid communication with the dispensing chamber. The ampoule receiving chamber has a cavity configured to receive an ampoule therein. The ampoule receiving chamber is formed of a deformable material. A second housing member is coupled to the first housing member to retain the internal housing member within the first housing member and the second housing member. At least a portion of the second housing member extends over the ampoule receiving chamber. A resilient member is provided that 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 a fluid dispensing patch that can be applied, for example, to a user’s skin for dispensing a fluid, such as a medicament, over time. The fluid dispensing patch provides for controlled delivery of the fluid from a breakable ampoulethat 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 microneedle array patch device in comparison to existing manufacturing processes.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 A is a side view of an exemplary fluid dispensing patch device of the present technology.

[0016] FIG. IB is a top view of the exemplary fluid dispensing patch device shown in FIG. 1A.

[0017] FIG. 1C is a bottom view of the exemplary fluid dispensing patch device shown in FIG. 1 A.

[0018] FIG. ID is an exploded perspective view of the exemplary fluid dispensing patch device shown in FIG. 1 A.

[0019] FIG. IE is a side cross-sectional view of the exemplary fluid dispensing patch device shown in FIG. 1 A.

[0020] FIG. 2A is a side cross-sectional view of an exemplary fluid dispensing patch having an entry port device for receiving an ampoule therein after assembly of the device and to seal the device after insertion.

[0021] FIG. 2B is a side cross-sectional view of another exemplary fluid dispensing patch having an entry port device for receiving an ampoule therein after assembly of the device and to seal the device after insertion.

[0022]

[0023] FIG. 3 A is a side cross-sectional view of an exemplary fluid dispensing patch device of the present technology in a storage state prior to initiating fluid delivery.

[0024] FIG. 3B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 3 A.

[0025] FIG. 4A is a side cross-sectional view of an exemplary fluid dispensing patch device of the present technology during rupture of the ampoule stored therein.

[0026] FIG. 4B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 4A.

[0027] FIG. 5A is a side cross-sectional view of an exemplary fluid dispensing patch device of the present technology after rupture of the ampoule stored therein during fluid delivery.

[0028] FIG. 5B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 5A.DETAILED DESCRIPTION

[0029] The present technology relates to a fluid dispensing patch device, and more specifically to a micro-needle array patch device for dispensing drugs or other fluids packaged in ampoules that can be crushed to release a fluid therein.

[0030] One aspect of the present technology relates to a fluid dispensing patch device. The fluid dispensing patch device includes a patch body having a first side and a second side, the patch body having an opening therein. A first housing member is located on the first side of the patch body. The first housing member includes a dispensing cavity aligned with the opening of the patch body. An elongate channel extends from the dispensing cavity. An internal housing member is configured to be coupled to the first housing member. The internal housing member includes a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body. An ampoule receiving chamber extends from and is in fluid communication with the dispensing chamber. The ampoule receiving chamber has a cavity configured to receive an ampoule therein. The ampoule receiving chamber is formed of a deformable material. A second housing member is configured to be coupled to the first housing member to retain the internal housing member within the first housing member and the second housing member. At least a portion of the second housing member extends over the ampoule receiving chamber. A 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.

[0031] FIGS. 1A-1E illustrate an example of a fluid dispensing patch device 10 of the present technology. The fluid dispensing patch device 10 includes a patch body 12, a first housing member 14, an internal housing member 16, a second housing member 18, a resilient member 20, and a first filter 24, although the fluid dispensing patch device 10 can include other types and / or numbers of elements in other combinations, including the additional examples described herein. In some examples, the fluid dispensing patch device 10 may include an ampoule 28 pre-loaded therein. The fluid dispensing patch device 10 advantageously provides a device that can be attached to the skin of a user to dispense a fluid stored in a breakable ampoule. The fluid dispensing patch device 10 can be used to rupture the ampoule, filter particles from the broken ampoule, and dispense the fluid. The fluid dispensing patch device 10 further allows fora controlled rate of delivery of the fluid to a specific location at, or just below, the surface of the user’s skin.

[0032] The patch body 12 has a configuration similar to conventional transdermal patches known in the art. The patch body 12 has a first side 30 and a second side 32 defined by opposing surfaces thereof. The first side 30 of the patch body 12 supports the additional elements of the fluid dispensing patch device 10 described herein, including the first housing member 14, the internal housing member 16, and the second housing member 18. The second side 32, as shown in FIG. 1C, is configured to interface with the patient’s skin / tissue, so that the fluid dispensing patch device 10 can be worn continuously for a period of time, during drug delivery, e.g., on a patient’s upper arm, thigh, abdomen, etc. In some examples, the second side 32 of the patch body 12 includes an adhesive 34 thereon configured to adhere the fluid dispensing patch device 18 to a user. The adhesive 34 can be selectively applied to any area on the second side 32 of the patch body 12. For example, the adhesive 34 may be suitable for semipermanent adhesion to skin tissue, such as adhesives known in the art for attaching continuous glucose monitor patches. In some examples, a removable protective sheet may be provided to cover the adhesive 34 to protect the adhesive 34 from contact or debris prior to use of the fluid dispensing patch device 10. The patch body 12 further defines an opening 36 that interacts with other elements of the fluid dispensing patch device 10, as described below, to facilitate fluid delivery.

[0033] The first housing member 14 is configured to be located on and supported by the first side 30 of the patch body 12. The first housing member 14 includes a dispensing cavity 38 that is aligned with the opening 36 of the patch body 12 when the first housing member 14 is located on the first side 30 thereof. The dispensing cavity 38 defines a dispensing opening 40 that allows fluid to flow to the opening 36 of the patch body 12. The first housing member 14 further includes an elongate channel 42 extending from and in fluid communication with the dispensing cavity 38. The first housing member 14 further includes a plurality of microneedles 44 located in the dispensing cavity 38. The plurality of microneedles 44 are configured to extend from the dispensing cavity 38 through the opening 36 of the patch body 12 to contact the patient’s skin when the fluid dispensing patch device 10 is applied thereto. The use of the plurality of microneedles limits pain for the patient and allows the fluid dispensing patch device 10 to be worn over an extended period of time.

[0034] The internal housing member 16 is configured to be coupled to an interior surface of the first housing member 14. In some examples, the internal housing member 16 and the first housing member 14 are configured to be coupled in a sealed engagement. The internal housingmember 16 includes a dispensing chamber 46 configured to be located within the dispensing cavity 38 of the first housing member 14 and in fluid communication therewith. Accordingly, the dispensing chamber 46 is also in fluid communication with the opening 36 of the patch body 12.

[0035] The internal housing member 16 further includes an ampoule receiving chamber 48 extending from and in fluid communication with the dispensing chamber 46. The ampoule receiving chamber 48 has an internal cavity 50 configured to receive an ampoule, such as the ampoule 28 shown in FIG. IE, therein. The ampoule receiving chamber 48 is formed of a deformable material, such as a deformable thin-walled elastomeric material, by way of example only. In this manner, an outer wall 52 of the ampoule receiving chamber 48 may be deformed under manual pressure during use, such as pressure applied by a user’s finger, as described in further detail below. The ampoule receiving chamber 48 includes an opening 54 that allows for insertion of the ampoule, such as ampoule 28 shown in FIG. IE, into the cavity 50.

[0036] In some examples, as shown in FIGS. 2A and 2B, for example, the ampoule receiving chamber 48 includes an entry port device 56 located proximate to the opening 54 to allow for the ampoule 28 to be inserted into the cavity 50 and to provide a seal for the opening 54 of the cavity 50 of the ampoule receiving chamber 48 after insertion. This configuration allows for the ampoule 28 to be inserted at the final stage of assembly. This allows for the fluid dispensing patch 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 fluid dispensing patch device 10 at the point-of-care. FIG. 2A illustrates one example of the fluid dispensing patch device 10 having entry port device 56 configured as a duck-billed valve for one-way insertion of the ampoule 28. FIG. 2B illustrates another example of the fluid dispensing patch device 10 having entry port device 56 that includes a living hinge 58, i.e., a bendable section of the ampoule receiving chamber 48 itself. In this example, the entry port device 56 further includes a cap 60 that is selectively inserted into the opening 54 of the cavity 50 of the ampoule receiving chamber 48 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 ampoule receiving chamber 48 to seal the ampoule receiving chamber 48 after insertion of the ampoule 28. This advantageously allows insertion of the ampoule 28 and sealing of the opening 54 of the cavity after assembly of the fluid dispensing patch device 10, i.e., as a later manufacturing step or at the point-of-care.

[0037] Referring again to FIGS. 1 A-1E, in some examples the opening 54 in the ampoule receiving chamber 48 is configured to receive a cap 66 that is separate from the ampoule receiving chamber 48 and is dimensioned to be received in the opening 54 to secure the ampoule, such as ampoule 28 shown in FIG. IE, therein. In some examples, the cap 66 provides a seal for the ampoule receiving chamber 48. In another example, as shown in FIG. IE, the cap 66 includes a vent 70 that allows air to escape from the ampoule receiving chamber 48 during use, as further described below. However, it is to be understood that the fluid dispensing patch device 10 could operate in a similar manner as described below without the use of vent 70.

[0038] The second housing member 18 is configured to be coupled to the first housing member 14 to retain the internal housing member 16 within the first housing member 14 and the second housing member 18. The second housing member 18 is shaped in similar fashion to the first housing member 14 to allow the two elements to mate to one another. The second housing member 18 includes a portion thereof that extends over the ampoule receiving chamber 48. In some examples, the second housing member 18, or at least portion thereof extending over the ampoule receiving chamber 48, is formed of a pliable material that is deformable material under pressure applied by a user, such as pressure applied by a user’s finger.

[0039] The resilient member 20 is configured to be moveable to apply a force to the ampoule receiving chamber 48 to rupture the ampoule 28 when located within the cavity 50 during use. For example, FIGS. 4A and 4B, described in further detail below, illustrate the resilient member 20 in a deformed state resulting from manual pressure applied thereto. Referring again to FIGS. 1 A-1E, in this example the resilient member 20 is part of the second housing member 18. However, it is to be understood that the resilient member 20 could be a separate component in other examples. In some examples, the resilient member 20 includes a projection 80 having a contact tip 82 that contacts the outer wall 52 of ampoule receiving chamber 48 to assist in breaking the ampoule 28. The contact tip 82 can be shaped to have a point having reduced surface area to assist in cracking the ampule 28. In this manner, the contact tip 82 concentrates the force applied on the resilient member 20 to a point to reduce the manual force required to break the ampoule 28. In this example, the contact tip 82 is configured to contact the ampoule 28 in a location proximate to the first filter 24.

[0040] The first filter 24 is configured to be positioned within the internal housing member 16 between the dispensing chamber 46 and the ampoule receiving chamber 48. The first filter 24 is configured to prevent particulate from moving from the ampoule receiving chamber 48 to the dispensing chamber 46 when the ampoule is ruptured. The first filter 24 allows fluid to flow from the ampoule receiving chamber 48 into the dispensing chamber 46.

[0041] In some examples, such as illustrated in FIGS. 1 A-1E, in which the cap 66 having vent 70 is employed, a second filter 72 is utilized. The second filter 72 is configured to be positioned in one of the cap 66 or the ampoule receiving chamber 48 to be positioned adjacent to the vent 70. In this example, the second filter 72 is formed of a hydrophobic material that allows air to flow through the vent 70 but prevents fluid from leaking out of the ampoule receiving chamber 48 through the vent 70.

[0042] In some examples, the fluid dispensing patch 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 transdermal application in a user’s skin. In other examples, the powder comprises a lyophilized medicament for transdermal application in a user’s skin, wherein bodily fluids are absorbed through the microneedles and serve as a diluent to reconstitute the lyophilized medicament.

[0043] Another aspect of the present technology relates to a method of making a fluid dispensing patch device. The method includes providing a patch body having a first side and a second side, the patch body having an opening therein. A first housing member is located on the first side of the patch body. The first housing member includes a dispensing cavity aligned with the opening of the patch body. An elongate channel extends from the dispensing cavity. An internal housing member is coupled to the first housing member. The internal housing member includes a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body. An ampoule receiving chamber extends from and is in fluid communication with the dispensing chamber. The ampoule receiving chamber has a cavity configured to receive an ampoule therein. The ampoule receiving chamber is formed of a deformable material. A second housing member is coupled to the first housing member to retain the internal housing member within the first housing member and the second housing member. At least a portion of the second housing member extends over the ampoule receiving chamber. A resilient member is provided that 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.

[0044] A method of making the fluid dispensing patch 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. ID, which shows an exploded view of the fluid dispensing patch device 10, first, the patch body 12 is provided. Thepatch body 12 includes the opening 36 defined therein. As shown in FIG. 1C, the second side 32 of the patch body has the adhesive 34 selectively located thereon to allow the patch body 12 to be adhered to the user’s skin during use.

[0045] Next, the first housing member 14 is located on the first side 30 of the patch body, such that the dispensing cavity 38 is aligned with the opening 36 of the patch body. The dispensing cavity 38 and the elongate channel 42, which extends therefrom, are supported by the patch body 12. The first housing member 14 can be coupled to the patch body 12 using known methods, including for example, adhesives, although the first housing member 14 can be coupled to the patch body 12 using other techniques.

[0046] Next, the internal housing member 16 is assembled. First filter 24 is inserted into the cavity 50 of the ampoule receiving chamber 48 to be located between the dispensing chamber 46 and the ampoule receiving chamber 48 to prevent particulates from entering the dispensing chamber 46, as described in further detail below. The ampoule 28 having a fluid stored therein can then be inserted into the cavity 50 of the ampoule receiving chamber 48 for storage. In some examples, as shown in FIGS. 2 A and 2B described above, the ampoule receiving chamber 48 includes the entry port device 56 to allow for insertion of the ampoule 28 after assembly of the fluid dispensing patch device 10, as described below, and sealing of the ampoule receiving chamber 48. 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. Referring again to FIG. ID, in this example, the cap 66 having the vent 70 is used to enclose the ampoule 28 within the cavity 50 of the ampoule receiving chamber 48.

[0047] Next, the internal housing member 16 is inserted into the first housing member 14. For example, the internal housing member 16 may be inserted into the first housing member 14 in a sealing engagement. Next, the second housing member 18 is applied over the internal housing member 16 and coupled to the first housing member 14, for example, through an adhesive. The second housing member 18 retains the internal housing member 16 within the first housing member 14. In some examples, at least a portion of the second housing member extends 18 over the ampoule receiving chamber 48 of the internal housing member 16. The resilient member 20 is provided to be moveable to apply a force to the ampoule receiving chamber 48 to rupture the ampoule 28 when located within the cavity 50 during use. In some examples, the resilient member 20 is integral to the second housing member 18, although it is to be understood that the resilient member 20 could be a separate component.

[0048] Another aspect of the present technology relates to a method of using the fluid dispensing patch device of the present technology. The method includes applying the patch body to the skin of a user. A force is applied 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. The force causes air to evacuate the dispensing chamber. The force applied to the resilient member is released to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber toward the opening of the patch body to dispense the fluid located therein.

[0049] An exemplary operation of the exemplary fluid dispensing device 10 of the present technology will now be described with respect to FIGS. 1 A-5B. First, the fluid dispensing patch device 10 is adhered to the user’s skin. The fluid dispensing patch device 10 is adhered using the adhesive 34 located on the second side of the patch body, as shown in FIG. 1C. The adhesive 34 may be selectively applied to any location on the second side 32 of the patch body 12. In some examples, the user removes a protective covering to expose the adhesive 34 prior to applying the fluid dispensing patch device 10. The fluid dispensing patch device 10 can be located at any desired location on the user’s skin, such as the user’s upper arm, thigh, or abdomen, by way of example only. The user applies the fluid dispensing patch device 10 by pressing the patch body 12 against the skin surface for application. As a result, the plurality of microneedles 44 located in the dispensing cavity 38 and extending through the opening 36 of the patch body 12, as shown for example in FIGS. 1C and IE, penetrate and are inserted into the user’s skin to allow for transdermal application of the fluid stored in fluid dispensing device 10. In some examples, the patch body 12 is applied such that the elongate channel 42 of the first housing member 14, as shown in FIG. IE for example, is positioned in an upright position when the user is in an upright position. This positioning allows gravity to advance the fluid toward the dispensing cavity 38 and the opening 36 of the patch body 12 during use. FIGS. 3A and 3B illustrate the fluid dispensing device 10 in a pre-delivery state when applied to the user’s skin. In this state, a fluid 74 is stored in the ampoule 28. The fluid 74 can be any fluid for delivery, including a medicament for transdermal application, by way of example.

[0050] Next, the user applies a force applying a force to the resilient member 20 to move the resilient member 20 to apply a force to the ampoule receiving chamber 48, as shown for example in FIGS. 4 A and 4B. The user can manually apply force using a thumb or finger, by way of example. As manual pressure is applied to the resilient member 20, the resilient member 20 deflects inwardly toward the ampoule receiving chamber 48. The manual pressure further deforms the outer wall 52 of the ampoule receiving chamber 48 to apply a force to the ampoule28 to rupture the ampoule 28, which is located within the cavity 50 of the ampoule receiving chamber 48.

[0051] The force applied must be sufficiently strong to rupture the ampoule 28. In some examples, as shown in FIGS. 4A and 4B, the resilient member 20 includes the projection 80 having the contact tip 82 that contacts the outer wall 52 of ampoule receiving chamber 48 to assist in breaking the ampoule 28. The contact tip 82 can be shaped to have a pointed shape providing a reduced surface area to concentrate the force applied through the projection 80 to assist in cracking the ampule 28. The contact tip 82 concentrates the force applied on the resilient member 20 to a point to reduce the manual force required to break the ampoule 28. In this example, the contact tip 82 is configured to contact the ampoule 28 in a location proximate to the first filter 24.

[0052] As shown in FIGS. 5 A and 5B, cracking the ampoule 28 leads to eventual rupture, which releases the fluid 74 stored therein into the cavity 50 of ampoule receiving chamber 48. The manual force further applied to the resilient member 20 further causes air to evacuate the dispensing chamber 46 as a result of the displacement shown in FIGS. 5A and 5B. In some examples, the fluid dispensing device includes a vent, such as vent 70 of cap 66 shown in FIG. IE. In this example, air is pushed through the vent 70 to exit the fluid dispensing patch device 10. However, it is to be understood that the fluid dispensing patch 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 fluid dispensing patch device 10.

[0053] Next, the user releases the manual force applied to the resilient member 20, which allows the resilient member 20 to deflect back to its original position as shown, for example, in FIGS. 6A and 6B, which show the ampoule 28 fully ruptured. Releasing the force applied to the resilient member 20 creates a negative pressure environment within the fluid dispensing patch device 10 that causes the fluid 74 to flow from the cavity 50 of the ampoule receiving chamber 48 to the dispensing chamber 46 and toward the opening 36 of the patch body 12 to dispense the fluid 74 to the skin of the user, by way of example. The first filter 24 located between the dispensing chamber 46 and the ampoule receiving chamber 48 allows fluid to flow from the ampoule receiving chamber 48 to the dispensing chamber, while preventing any particulate from the broken ampoule 28 from entering the dispensing chamber 46. In some examples, as the fluid 74 flows to the dispensing chamber 46, air is pulled into the ampoule receiving chamber 48 through the vent 70, as shown in FIG. IE.

[0054] Once the fluid 74 enters the dispensing chamber 46, the fluid 74 gradually migrate, over time, through the opening 36 in the patch body 12 to be delivered to user’s skin in a controlled manner. The microneedles 44 allow the fluid 74 to move into the user’s tissue.

[0055] Accordingly, the present technology provides a fluid dispensing patch device that can be applied to a user’s skin to allow for precise, controlled delivery, over time, of a fluid. 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.

[0056] 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 and these are therefore considered to be within the scope of the invention as defined in the claims which follow.

Claims

What is claimed is:

1. A fluid dispensing patch device comprising: a patch body having a first side and a second side, the patch body having an opening therein; a first housing member located on the first side of the patch body, the first housing member comprising: a dispensing cavity aligned with the opening of the patch body; and an elongate channel extending from the dispensing cavity; an internal housing member configured to be coupled to the first housing member, the internal housing member comprising: a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body; an ampoule receiving chamber extending from and in fluid communication with the dispensing chamber, the ampoule receiving chamber having a cavity configured to receive an ampoule therein, wherein the ampoule receiving chamber is formed of a deformable material; a second housing member configured to be coupled to the first housing member to retain the internal housing member within the first housing member and the second housing member, wherein at least a portion of the second housing member extends over the ampoule receiving chamber; and 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 fluid dispensing patch of claim 1 further comprising a vent cap configured to be positioned in the cavity of the ampoule receiving chamber, the vent cap having a vent configured to allow air to pass out of the ampoule receiving device.

3. The fluid dispensing patch device of claim any of the preceding claims further comprising: a plurality of microneedles located in the dispensing cavity and extending through the opening of the patch body.

4. The fluid dispensing patch device of any of the preceding claims further comprising: an adhesive located on the second side of the patch body and configured to adhere the fluid dispensing patch device to a user.

5. The fluid dispensing patch device of any of the preceding claims, wherein the internal housing member and the first housing member are configured to be coupled in a sealed engagement.

6. The fluid dispensing patch device of any of the preceding claims further comprising: a first filter configured to be positioned within the internal housing member between the dispensing chamber and the ampoule receiving chamber.

7. The fluid dispensing patch device of claim 6, wherein the first filter is configured to prevent particulate from moving from the ampoule receiving chamber to the dispensing chamber.

8. The fluid dispensing patch device of any of the preceding claims further comprising: a second filter configured to be positioned in one of the vent cap or the ampoule receiving chamber to be positioned adjacent to the vent.

9. The fluid dispensing patch device of claim 8, wherein the second filter is formed of a hydrophobic material.

10. The fluid dispensing patch device of any of the preceding claims further comprising: the ampoule having a fluid stored therein.

11. The fluid dispensing patch device of claim 10, wherein the fluid comprises a medicament.

12. The fluid dispensing patch device of any of the preceding claims, wherein the resilient member further comprises a contact tip configured to contact the ampoule receiving chamber to apply the force to the ampoule receiving chamber.

13. The fluid dispensing patch of any of the preceding claims, wherein the ampoule receiving chamber further comprises an entry port device configured to allow an ampoule to be inserted therein.

14. The fluid dispensing patch of claim 13, wherein the entry port device comprises one of a duck-bill valve or a living hinge.

15. A method of using the fluid dispensing patch device of any of the preceding claims, the method comprising: applying the patch body to the skin of a user; 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, wherein the force causes air to evacuate the dispensing chamber; and releasing the force applied to the resilient member to create a negative pressure environment that causes the fluid to flow from the ampoule receiving chamber to the dispensing chamber toward the opening of the patch body to dispense the fluid located therein.

16. The method of claim 15 wherein the patch body comprises an adhesive located on the second side configured to adhere the fluid dispensing patch device to a user, wherein applying the patch body to the skin of the user further comprises adhering the fluid dispensing patch device to the skin of the user using the adhesive.

17. The method of claim 15 or claim 16 further comprising: removing a protective covering from the adhesive prior to adhering the fluid dispensing patch device to the skin of the user.

18. The method of any one of claims 15 through claim 17, wherein the fluid dispensing patch device further comprises a plurality of microneedles located in the dispensing cavity and extending through the opening of the patch body, wherein applying the patch body tothe skin of the user further comprises inserting the plurality of microneedles into the skin of the user.

19. The method of any one of claims 15 through claim 18, wherein the patch body is applied such that the elongate channel is positioned in an upright position when the user is in an upright position.

20. The method of any one of claims 15 through claim 19, wherein the fluid comprises a medicament.

21. A method of making a fluid dispensing patch device, the method comprising: providing a patch body having a first side and a second side, the patch body having an opening therein; locating a first housing member on the first side of the patch body, the first housing member comprising: a dispensing cavity aligned with the opening of the patch body; and an elongate channel extending from the dispensing cavity; coupling an internal housing member to the first housing member, the internal housing member comprising: a dispensing chamber configured to be located within the first dispensing cavity of the first housing member and in fluid communication with the dispensing cavity of the first housing member and the opening of the patch body; and an ampoule receiving chamber extending from and in fluid communication with the dispensing chamber, the ampoule receiving chamber having a cavity configured to receive an ampoule therein, wherein the ampoule receiving chamber is formed of a deformable material; and coupling a second housing member to the first housing member to retain the internal housing member within the first housing member and the second housing member, wherein at least a portion of the second housing member extends over the ampoule receiving chamber; and providing 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.

22. The method of claim 21 further comprising: positioning a vent cap in the cavity of the ampoule receiving chamber, the vent cap having a vent configured to allow air to pass out of the ampoule receiving device.

23. The method of claim 21 or claim 22 further comprising: inserting the ampoule comprising a medicament located therein through an opening in the ampoule receiving chamber into the cavity of the ampoule receiving chamber prior to coupling the internal housing member to the first housing member.

24. The method of any one of claims 21 through claim 23 further comprising: positioning a first filter within the internal housing member between the dispensing chamber and the ampoule receiving chamber.

25. The method of any one of claims 22 further comprising: positioning a second filter in one of the vent cap or the ampoule receiving chamber adjacent to the vent.

26. The method of any one of claims 21 through claim 25, wherein the ampoule receiving chamber 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 into the cavity of the ampoule receiving chamber through the opening.

27. The method of claim 26, wherein the entry port device comprises a duck-bill valve.

28. The method of claim 26, wherein the entry port device comprises a cap coupled to the ampoule receiving chamber 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.

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