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WO2025221623A1 - Dispositif de timbre de distribution de fluide et ses procédés d'utilisation et de fabrication - Google Patents

Dispositif de timbre de distribution de fluide et ses procédés d'utilisation et de fabrication

Info

Publication number
WO2025221623A1
WO2025221623A1 PCT/US2025/024416 US2025024416W WO2025221623A1 WO 2025221623 A1 WO2025221623 A1 WO 2025221623A1 US 2025024416 W US2025024416 W US 2025024416W WO 2025221623 A1 WO2025221623 A1 WO 2025221623A1
Authority
WO
WIPO (PCT)
Prior art keywords
ampoule
housing member
dispensing
receiving chamber
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/024416
Other languages
English (en)
Inventor
Eric Sugalski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2025221623A1 publication Critical patent/WO2025221623A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05B—SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES
    • B05B11/00—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use
    • B05B11/01—Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use characterised by the means producing the flow
    • B05B11/04—Deformable containers producing the flow, e.g. squeeze bottles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B67—OPENING, CLOSING OR CLEANING BOTTLES, JARS OR SIMILAR CONTAINERS; LIQUID HANDLING
    • B67B—APPLYING CLOSURE MEMBERS TO BOTTLES JARS, OR SIMILAR CONTAINERS; OPENING CLOSED CONTAINERS
    • B67B7/00—Hand- or power-operated devices for opening closed containers
    • B67B7/92—Hand- or power-operated devices for opening closed containers by breaking, e.g. for ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053—Methods for producing microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061—Methods for using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • microneedle array patch devices 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.
  • 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.
  • 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.
  • 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.
  • 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 ampoule that stores and protects the fluid prior to usage.
  • 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.
  • FIG. 1 A is a side view of an exemplary fluid dispensing patch device of the present technology.
  • FIG. IB is a top view of the exemplary fluid dispensing patch device shown in FIG. 1A.
  • FIG. 1C is a bottom view of the exemplary fluid dispensing patch device shown in FIG. 1 A.
  • FIG. ID is an exploded perspective view of the exemplary fluid dispensing patch device shown in FIG. 1 A.
  • FIG. IE is a side cross-sectional view of the exemplary fluid dispensing patch device shown in FIG. 1 A.
  • 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.
  • 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.
  • 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.
  • FIG. 3B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 3 A.
  • 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.
  • FIG. 4B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 4A.
  • 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.
  • FIG. 5B is an enhanced view of a portion the exemplary fluid dispensing patch device shown in FIG. 5A.
  • 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.
  • 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.
  • 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.
  • 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 for a controlled rate of delivery of the fluid to a specific location at, or just below, the surface of the user’s skin.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 housing member 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the cap 66 provides a seal for the ampoule receiving chamber 48.
  • the cap 66 includes a vent 70 that allows air to escape from the ampoule receiving chamber 48 during use, as further described below.
  • vent 70 allows air to escape from the ampoule receiving chamber 48 during use, as further described below.
  • the fluid dispensing patch device 10 could operate in a similar manner as described below without the use of vent 70.
  • 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.
  • 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.
  • 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.
  • FIGS. 4A and 4B illustrated in further detail below, illustrate the resilient member 20 in a deformed state resulting from manual pressure applied thereto.
  • the resilient member 20 is part of the second housing member 18.
  • the resilient member 20 could be a separate component in other 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.
  • 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.
  • a second filter 72 is utilized in some examples, such as illustrated in FIGS. 1 A-1E, in which the cap 66 having vent 70 is employed.
  • 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.
  • 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.
  • 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.
  • the fluid comprises a medicament for transdermal application in a user’s skin.
  • 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.
  • 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.
  • FIG. ID shows an exploded view of the fluid dispensing patch device 10.
  • the patch body 12 is provided.
  • the patch body 12 includes the opening 36 defined therein.
  • 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.
  • 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.
  • 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.
  • 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.
  • the ampoule 28 can be provided separately and installed by a different manufacturer or a user at the point-of-care.
  • the cap 66 having the vent 70 is used to enclose the ampoule 28 within the cavity 50 of the ampoule receiving chamber 48.
  • the internal housing member 16 is inserted into the first housing member 14.
  • the internal housing member 16 may be inserted into the first housing member 14 in a sealing engagement.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 3A and 3B illustrate the fluid dispensing device 10 in a pre-delivery state when applied to the user’s skin.
  • 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.
  • 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.
  • 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 ampoule 28 to rupture the ampoule 28, which is located within the cavity 50 of the ampoule receiving chamber 48.
  • 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.
  • the contact tip 82 is configured to contact the ampoule 28 in a location proximate to the first filter 24.
  • 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.
  • 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.
  • 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.
  • air is pulled into the ampoule receiving chamber 48 through the vent 70, as shown in FIG. IE.
  • 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.
  • 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.

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Abstract

Un dispositif de timbre de distribution de fluide est divulgué. Le dispositif de timbre de distribution de fluide comprend un corps de timbre. Un premier élément de boîtier est situé dans le corps de timbre et comprend une cavité de distribution et un canal allongé. Un élément de boîtier interne est conçu pour être couplé au premier élément de boîtier. L'élément de boîtier interne comprend une chambre de distribution et une chambre de réception d'ampoule qui s'étend à partir de la chambre de distribution et est en communication fluidique avec celle-ci. La chambre de réception d'ampoule présente une cavité conçue pour recevoir une ampoule à l'intérieur de celle-ci et est formée d'un matériau déformable. Un second élément de boîtier est conçu pour être couplé au premier élément de boîtier afin de retenir l'élément de boîtier interne. Un élément élastique est conçu pour être mobile pour appliquer une force à la chambre de réception d'ampoule afin de rompre l'ampoule lorsqu'il est situé à l'intérieur de la cavité pendant l'utilisation. Sont également divulguées des procédés de fabrication et d'utilisation.
PCT/US2025/024416 2024-04-15 2025-04-11 Dispositif de timbre de distribution de fluide et ses procédés d'utilisation et de fabrication Pending WO2025221623A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463633925P 2024-04-15 2024-04-15
US63/633,925 2024-04-15

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WO2025221623A1 true WO2025221623A1 (fr) 2025-10-23

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100179473A1 (en) * 2006-12-29 2010-07-15 Amir Genosar Hypodermic drug delivery reservoir and apparatus
US20120241465A1 (en) * 2009-08-30 2012-09-27 Aktivpak, Inc. Dispensing device along with method for dispensing product
US20210085942A1 (en) * 2019-09-25 2021-03-25 3M Innovative Properties Company Liquid applicator
US20220143303A1 (en) * 2019-04-23 2022-05-12 Synolus Medical, Inc. Wearable Injector
US20220273928A1 (en) * 2015-04-07 2022-09-01 Lts Lohmann Therapie-Systeme Ag Microneedle system for administering liquid formulations
US20230293749A1 (en) * 2022-03-17 2023-09-21 Becton, Dickinson And Company Skin Preparation Applicator

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100179473A1 (en) * 2006-12-29 2010-07-15 Amir Genosar Hypodermic drug delivery reservoir and apparatus
US20120241465A1 (en) * 2009-08-30 2012-09-27 Aktivpak, Inc. Dispensing device along with method for dispensing product
US20220273928A1 (en) * 2015-04-07 2022-09-01 Lts Lohmann Therapie-Systeme Ag Microneedle system for administering liquid formulations
US20220143303A1 (en) * 2019-04-23 2022-05-12 Synolus Medical, Inc. Wearable Injector
US20210085942A1 (en) * 2019-09-25 2021-03-25 3M Innovative Properties Company Liquid applicator
US20230293749A1 (en) * 2022-03-17 2023-09-21 Becton, Dickinson And Company Skin Preparation Applicator

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