CN120265352A - Microneedle patch with force feedback indicator - Google Patents
Microneedle patch with force feedback indicator Download PDFInfo
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- CN120265352A CN120265352A CN202380068692.0A CN202380068692A CN120265352A CN 120265352 A CN120265352 A CN 120265352A CN 202380068692 A CN202380068692 A CN 202380068692A CN 120265352 A CN120265352 A CN 120265352A
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- microneedle patch
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- 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
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- 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
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- 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
- A61M2037/0046—Solid 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
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A microneedle patch is provided that includes a microneedle array, a base substrate from which microneedles extend, and a Force Feedback Indicator (FFI) attached to the base substrate. The FFI includes a base and a button having an upper surface and a side surface, wherein the button is configured to translate within the base from a pre-actuated position into an actuated position, wherein the side surface is substantially visible in the pre-actuated position and substantially invisible in the actuated position. The side surface has a different color than the upper surface and/or substrate, which helps to visually confirm the actuation state of the button, which can help to indicate whether the microneedle patch is ready for use or already in use. The FFI can be configured to provide tactile, audible, and visual confirmation of sufficient force applied to a microneedle patch to effect insertion of the microneedles.
Description
Cross Reference to Related Applications
The present application claims priority from U.S. provisional application No. 63/405,932 filed on 9/13, 2022, which is incorporated herein by reference.
Background
The present application is generally in the field of microneedle patches for the administration of bioactive agents or other suitable substances into biological tissue, for example, for the administration of vaccines, contraceptives or other medicaments into the skin of a human.
It would be desirable to provide an improved microneedle patch that can simplify and improve the delivery of vaccines and other agents, store the agents in dry form, can be easily and consistently manually applied, e.g., without a separate applicator device, can deliver an agent payload into the skin in a short duration, e.g., so that the patch can be removed from the skin within minutes of application to the skin, does not leave a sharp microneedle after application of the agent payload, and includes a feedback indicator to confirm that sufficient manual force has been applied to the patch to ensure that the microneedle has been fully or properly inserted into the skin, and/or an indicator to indicate that the microneedle patch has been used.
It is also desirable to provide new and improved systems for packaging and protecting microneedles of microneedle patches prior to use. In particular, it may be important to provide such a system in a compact design, wherein the microneedle patch product must remain cold during shipping and storage prior to use.
Disclosure of Invention
In one aspect, a microneedle patch is provided comprising an array of microneedles, a base substrate having a first side and an opposite rear side, the microneedles extending from the first side, and a Force Feedback Indicator (FFI) attached to the rear side of the base substrate, wherein the FFI includes a base and a button having an upper surface and a side surface, wherein the button is configured to translate within the base from a pre-actuated position into an actuated position, wherein the side surface is substantially visible in the pre-actuated position and substantially invisible in the actuated position. The FFI is preferably configured to further provide a tactile and/or audible confirmation of sufficient force applied to the microneedle patch to effect insertion of the microneedles. In certain embodiments, the side surface has a different color than the color of the upper surface and/or the color of the substrate, which helps to visually confirm the actuation state of the button, which can help indicate whether the microneedle patch is ready for use or already in use.
In another aspect, a microneedle patch is provided that includes an array of dissolvable microneedles, a base substrate having a first side and an opposite rear side from which the microneedles extend, and a Wear Time Indicator (WTI) attached to the rear side of the base substrate and configured to provide a visual indication that the microneedle patch has been worn on the skin of a user for a period of time sufficient to achieve dissolution of the microneedles after insertion into the skin of the user. (the period of time is the wear time.) in a particular embodiment, the WTI comprises a dye blister and a core assembly, wherein the dye blister has a rupturable dye reservoir configured to release dye into the core assembly upon application of a force to the microneedle patch to effect insertion of the microneedles. The location of the dye within the core assembly corresponds to the wear time.
In another aspect, a microneedle patch is provided comprising an array of microneedles, a base substrate having a first side and an opposite rear side, the microneedles extending from the first side, and a Force Feedback Indicator (FFI) comprising a base and a button, wherein the base substrate and the array of microneedles are attached only to the button of the FFI, wherein the button is configured to translate within the base from a pre-actuated position into an actuated position, and wherein the base of the FFI is sized such that in the pre-actuated position the array of microneedles is in a position recessed in an opening in a lower surface of the base of the FFI. In a particular embodiment, at least an upper portion of the button in the pre-actuated position is raised above the base and at least an upper portion of the button in the actuated position is flush with or recessed into the base. The button may have an upper surface and a side surface, wherein the side surface is substantially visible in the pre-actuated position and substantially invisible in the actuated position. In some embodiments, the button of the FFI comprises a latch, and the housing comprises (i) a first latch receptacle configured to receive the latch and releasably retain the button in the pre-actuated position, and (ii) a second latch receptacle configured to receive the latch and non-releasably retain the button in the actuated position. In a particular embodiment, the microneedle patch is configured such that a first minimum force on the button is effective to remove the latch from the first latch receptacle and displace the button toward the base and begin inserting the microneedle into the tissue surface, and such that a second minimum force on the button, which may be greater than the first minimum force, is effective to move the latch into the second latch receptacle and trigger a tactile signal and/or audible signal that sufficient force has been applied to the microneedle patch to achieve full insertion of the microneedle into the tissue surface.
In yet another aspect, microneedle patch packaging units and systems are provided. In one embodiment, a microneedle patch package system is provided that includes (i) a microneedle patch having an adhesive surface, and (ii) a foil or other pouch material adhered to the adhesive surface, wherein the foil or other pouch material is folded and sealed to form a sealed pouch surrounding at least one of the microneedle patches. In another embodiment, a microneedle patch package unit is provided that includes (i) a microneedle patch having a process tab, (ii) a package tray having a cavity in which the microneedle patch is disposed, and (iii) a foil or other film attached to the tray to seal the cavity, wherein the package system is configured such that upon removal of the foil or other film from the tray, the process tab is positioned toward an opening of the cavity to facilitate grasping the process tab to remove the microneedle patch from the package tray. In some embodiments, such an advantageous handling tab location may be achieved by a design in which the handling tab is folded on top of the microneedle patch within the sealing tray and partially unfolds itself when the foil or other film is removed from over the cavity. In another embodiment, a packaging system is provided comprising a plurality of such microneedle patch packaging units, wherein an edge of a packaging tray of each packaging unit is releasably attached at an edge of at least one other packaging tray of another packaging unit, for example wherein the releasably attached edge is defined by a perforation line in the shared sheet material.
Drawings
The detailed description is set forth with reference to the drawings. The use of the same reference numbers may indicate similar or identical items. Various embodiments may utilize elements and/or components other than those shown in the figures, and some elements and/or components may not be present in various embodiments. Elements and/or components are not necessarily drawn to scale.
Fig. 1A and 1B are perspective and exploded views, respectively, of a microneedle patch having an FFI according to one or more embodiments of the present disclosure.
Fig. 2A is a side view of a microneedle patch with an FFI according to one or more embodiments of the present disclosure.
Fig. 2B is an upper perspective view of the microneedle patch shown in fig. 2A, according to one or more embodiments of the present disclosure.
Fig. 2C is a bottom view (microneedle array side) of the microneedle patch shown in fig. 2A, according to one or more embodiments of the present disclosure.
Fig. 2D is a top view (button side) of the microneedle patch shown in fig. 2A, according to one or more embodiments of the present disclosure.
Fig. 3A is a perspective view of a storage tray for microneedle patches according to one or more embodiments of the present disclosure.
Fig. 3B is a bottom perspective view of the storage tray of fig. 3A in which microneedle patches are stored, according to one or more embodiments of the present disclosure.
Fig. 3C is a top perspective view of the storage tray of fig. 3A in which microneedle patches are stored, according to one or more embodiments of the present disclosure.
Fig. 4A is a top perspective view of a microneedle patch according to one or more embodiments of the present disclosure, with an upper portion of a button of the FFI in a pre-actuated position raised above a base of the FFI. The downward pointing arrow shows the force applied to the button.
Fig. 4B is a top perspective view of the microneedle patch shown in fig. 4A, but with an upper portion of a button of the FFI in an actuated position slightly recessed into the base of the FFI, in accordance with one or more embodiments of the present disclosure.
Fig. 5A is a side cross-sectional view of a microneedle patch according to one or more embodiments of the present disclosure, with a button of the FFI in a pre-actuated position raised above a base of the FFI and a microneedle array recessed within the base.
Fig. 5B is a side cross-sectional view of the microneedle patch of fig. 5A, but with the buttons of the FFI recessed into the base of the FFI and the microneedle array extending from the base in an actuated position, according to one or more embodiments of the present disclosure.
Fig. 6A through 6C are photomicrographs of dissolved microneedles according to one or more embodiments of the present disclosure.
Fig. 7A-7C depict a process of using a microneedle patch in accordance with one or more embodiments of the present disclosure, in which its microneedles are inserted into biological tissue and dissolved and separated from the patch backing.
Fig. 8 depicts steps in a molding process in accordance with one or more embodiments of the present disclosure, wherein a droplet is placed onto a mold for a segmented microneedle array.
Fig. 9 is a bottom perspective view of a microneedle patch having a segmented microneedle array according to one or more embodiments of the present disclosure.
Fig. 10A is a perspective view of a packaging unit containing a microneedle patch stored in a rectangular storage container (tray) and surrounded by a removable cover material, wherein the storage container and cover material are transparent and shown in phantom, according to one or more embodiments of the present disclosure.
Fig. 10B is a perspective view of a packaging system according to one or more embodiments of the present disclosure, the packaging system comprising ten packaging units shown in fig. 10A, wherein nine units are attached to at least one other unit along a butt-side edge. The other unit is shown as separate, having been separated from the other unit along the perforation line.
Fig. 10C is a perspective view of another packaging system including a box-shaped stack of five packaging systems shown in fig. 10B, wherein the boxes are transparent and shown in phantom, according to one or more embodiments of the present disclosure.
Fig. 11A is a perspective view of another packaging system according to one or more embodiments of the present disclosure, the another packaging system comprising a plurality of microneedle packaging units, each microneedle packaging unit comprising a trapezoidal storage tray, and wherein each unit is shown attached to at least one other unit along a butt-side edge.
Fig. 11B is a perspective view of an opened microneedle packaging unit of the microneedle packaging unit shown in fig. 11A, in which the microneedle patch is positioned with a cavity of a tray (with cover material removed), according to one or more embodiments of the present disclosure.
Fig. 12 is an exploded view of a wear time indicator for a microneedle patch according to one or more embodiments of the present disclosure.
Fig. 13A-13D illustrate timing shots of the wear time indicator of fig. 12 in use in accordance with one or more embodiments of the present disclosure.
Detailed Description
Improved microneedle patches and systems have been developed to provide enhanced usability, convenience, handling/storage capability and/or functionality.
The microneedle patch includes an array of microneedles extending from a base substrate that is connected to other components that facilitate handling and insertion of the microneedles. Those components typically contain a tape layer comprising an adhesive face and a handling tab, and may further contain a Force Feedback Indicator (FFI) or a Wear Time Indicator (WTI). In certain embodiments, the FFI and WTI are not electronic. In practice, they operate mechanically and are typically made from relatively inexpensive polymeric components that can be produced in a high volume manufacturing process.
In some preferred embodiments, the microneedles comprise a substance of interest and a water-soluble matrix material dispersed with the substance of interest.
In some embodiments, a Force Feedback Indicator (FFI) is attached to a rear side of a base substrate, wherein the FFI includes a base and a button having an upper surface and a side surface, wherein the button is configured to translate within the base from a pre-actuated position into an actuated position, wherein the side surface is substantially visible in the pre-actuated position and substantially invisible in the actuated position. The FFI is preferably configured to further provide a tactile and/or audible confirmation of sufficient force applied to the microneedle patch to effect insertion of the microneedles.
In some embodiments, a microneedle patch includes an array of microneedles, a base substrate having a first side and an opposite rear side from which the microneedles extend, a tape layer including an adhesive face and a handling tab, and a Force Feedback Indicator (FFI) secured to the tape layer. The FFI may be configured to provide an audible tactile and/or visual signal when a force applied to the patch by a user meets or exceeds a predetermined threshold during application of the patch to biological tissue to insert solid microneedles into the biological tissue. The tape layer may be a double sided tape, a plastic film with adhesive disposed on either or both sides, or a double sided tape.
In some embodiments, the tape layer includes an aperture through which a central portion of the substrate extends, and the microneedle array is mounted on this central portion to lift the microneedles from the surrounding tape layer and away from its adhesive face, which facilitates insertion of the microneedles when the adhesive face is pressed against and adhered to the skin surface. The raised microneedles may also provide the force required to maintain the microneedle array within the skin (i.e., provide a compressive force on the microneedles) for the duration of the patch wear time.
Some examples of suitable microneedle arrays and methods of making the same that may be used with the microneedle patches and packaging systems of the present invention are described in U.S. patent 10,265,511, U.S. patent No. 10,828,478, U.S. patent No. 10,828,478, U.S. patent No. 10,940,301, and U.S. patent No. 20200238065A1, which are incorporated herein by reference.
The microneedle patch may comprise an array comprising any suitable number of microneedles, such as 10 to 10,000 microneedles, such as 50 to 1000 microneedles. The periphery of the array may have a circular (e.g., as shown in fig. 1) or hexagonal (e.g., as shown in fig. 2A-2D) outer shape, both of which may extend from a circular or another shaped substrate.
In a preferred embodiment, the microneedles are solid microneedles which contain a substance of interest (e.g., an Active Pharmaceutical Ingredient (API)) that dissolves in the body after insertion of the microneedles into biological tissue, such as into the skin of a patient. For example, the substance of interest may be mixed in a water-soluble matrix to form solid microneedles extending from a base substrate, or the substance of interest may take the form of a coating on a microneedle substructure extending from a base substrate. In either case, the substance of interest may be provided in a formulation referred to herein as "dissolvable". In embodiments where the substance of interest and the matrix material in which the substance of interest is dispersed form the structure of the microneedle, the matrix material is also preferably dissolvable in the body such that the entire portion of the microneedle inserted into the biological tissue dissolves in the body (e.g., about 90% to 95% of the total length of the microneedle). In embodiments where the substance of interest is part of a coating on the microneedle substructure, the substructure may also be dissolved in the body.
The microneedles may have a height of from about 100 μm to about 2000 μm, from about 100 μm to about 1500 μm, from about 100 μm to about 1000 μm, or from about 500 μm to about 1000 μm. The microneedles may be arranged on the base substrate at any suitable density.
Microneedle patch with Force Feedback Indicator (FFI)
An exemplary microneedle patch having an FFI and a plurality of solid microneedles is shown in fig. 1. Patch 100 includes a base substrate 102 having a plurality of microneedles 104. A plurality of microneedles 104 are attached to an FFI 106. Microneedles 104 and FFIs 106 may be attached to backing layer 108 via openings 110 therein. That is, backing layer 108 may include openings 110 sized and shaped to receive a plurality of microneedles 104 and FFIs 106 within openings 110. In some embodiments, the base substrate 102 holding the plurality of microneedles 102 is attached to the FFI 106 by a first adhesive layer 112 and the FFI 106 is attached to the backing layer 108 by a second adhesive layer 114. In other embodiments, base substrate 102 and backing layer 108 are integrally formed with FFI 106.
In some embodiments, the backing layer 108 may include tab portions 116 that extend laterally away from the microneedles 104. Or the tab portions may be disposed in a separate layer (not shown). Thus, the tab portions may be in the same plane as the backing layer or in different planes. "backing layer" and "handle layer" may be used interchangeably in this disclosure unless explicitly provided otherwise. The tab portion 108 may advantageously enable a patient or user to process the patch 100 without contacting the "body portion" of the patch defined by the base substrate 102 and the plurality of microneedles 104. For example, the tab portion 116 may be sized and shaped to allow a person to manually grasp the tab portion 116 (e.g., between a thumb and finger). Although tab portion 116 is shown in fig. 1 as extending laterally and asymmetrically from backing layer 108, other shapes and sizes are possible.
In some embodiments, an adhesive (not shown) is disposed on the microneedle 104 side of the backing layer 108 to help adhere the patch 100 to the patient's skin during application. The adhesive may also be used to adhere the patch to a tray or container covering a plurality of microneedles during shipping and storage, as well as for handling after use thereof. In one embodiment, tab portion 116 is substantially free of an adhesive layer, enabling the person handling and applying the patch to do so without contacting the adhesive layer. In some embodiments, the adhesive layer may be disposed over substantially the entire side of the backing layer 108 that includes the tab portion 116. A cover portion (not shown) may be disposed over the adhesive layer over tab portion 116 such that a person holding patch 100 through the tab portion does not contact a substantial portion of the adhesive layer.
FFI 106 comprises a base 118 and a button 120 configured to translate within base 118. The base 118 may include a central portion 122, an outer portion 124, and an intermediate portion 126 between the central portion 122 and the outer portion 124 and connecting the central portion 122 and the outer portion 124. The base substrate 102 carrying the microneedles 104 is attached to a central portion 122 of the base 118 via the first adhesive layer 112. An outer portion 124 of the substrate 118 may be attached to the back side (i.e., the side opposite the microneedles) of the backing layer 108 via the second adhesive layer 114. That is, the second adhesive layer 114 may have a ring-like shape such that the second adhesive 114 may be placed around the central portion 122 and the intermediate portion 126 and onto the outer portion 124.
The button 120 may be slidably attached to the base 118 by one or more slots 128 disposed around the circumference of the middle portion 126 of the base 118. That is, with respect to fig. 1, the button 120 may have one or more upwardly extending protrusions 130 configured to be received within one or more slots 128 of the base 118. Each of the one or more protrusions 130 may also include a lip 132 to secure the protrusion 130 within the slot 128, which may prevent inadvertent removal of the button 120 from the base 118.
The button 120 may also include an upper surface 134 and a side surface 136. The button 120 may translate from a pre-actuated position to an actuated position, wherein the side surface 136 is visible in the pre-actuated position and substantially invisible in the actuated position. For example, as shown in fig. 4A-4C, when patch 100 is assembled, button 120 may be initially positioned convexly above backing layer 108 and base 118 of the feedback indicator. Upon applying a downward force to the top of the button 120 (i.e., the patient or user presses the button 120), the button 120 may move downward into the central portion 122 of the base 118. When the button 120 is fully translated from the pre-actuated position to the actuated position, the button 120 is fully seated within the base 118 and is no longer visible. In some embodiments, the side surface 136 may be formed of a material having a different color than the rest of the feedback indicator 106, which may help the user better identify when the button 120 has been fully translated from the pre-actuated position to the actuated position, thereby indicating that the plurality of microneedles 104 have been at least partially inserted into tissue.
FFI 106 also contains an ancillary mechanism for providing feedback to the user to aid in proper and efficient use of the microneedle patch. For example, in some cases, translating the button 120 to the actuated position may not be sufficient to fully insert the microneedles 104 into tissue. That is, actuating the button 120 from the pre-actuated position to the actuated position may only be sufficient to penetrate tissue and partially insert the microneedles 104, requiring additional force to fully insert the microneedles 104 into the skin. In other cases, it may be advantageous to utilize an auxiliary feedback mechanism so that the patient or user ensures that the microneedles have been fully inserted. The secondary feedback may be provided in various forms or combinations, including tactile (e.g., a detectable sensation felt by the person or patient applying the patch), audible (e.g., the presence, absence, or change in sound).
Feedback may be provided to various "users," including but not limited to the person (e.g., patient) to whom the microneedle patch is applied, as well as any other person (healthcare provider, caregiver, parent, guardian) who applies the microneedle patch to the person.
In a preferred embodiment, the FFI indicates to the user the amount of force and/or pressure applied to the patch during its application. For example, in one embodiment, the indicator is configured to provide a signal when the force applied to the patch by the user (during application of the patch to the skin of the patient to insert the microneedle into the skin of the patient) meets or exceeds a predetermined threshold. For example, the predetermined threshold may be a minimum force or some amount greater than a minimum force required to effectively apply a particular microneedle patch to the skin of a patient. That is, the predetermined threshold is the force required to properly insert the microneedle, e.g., substantially into the skin of the patient.
The FFI can signal to the user that a predetermined threshold has been met or exceeded in a variety of different ways. In one embodiment, the FFI may change from its initial configuration to its signaling configuration upon receiving a force that meets or exceeds a predetermined threshold.
In some embodiments, FFI 106 also includes a snap dome 138 disposed within button 120, which may be designed to collapse (deform) upon application of sufficient force to meet or exceed a predetermined threshold. The shrinkage may be audible as a click and/or may be felt by the user's finger used to apply the patch. In this way, the snap dome provides the user with a tactile, visual, and audible signal that the threshold force is met or exceeded and that the patch has been properly applied to the patient's skin. The snap dome may be a bistable snap dome. The FFI is preferably configured to undergo irreversible displacement by integrating the snap dome with other components, such as a button and a base that lock together as described herein.
Another microneedle patch with integrated FFI is shown in fig. 5A-5B. The microneedle patch 400 includes a base substrate 402 having an array 404 of microneedles. Base substrate 402 is attached to button 416 only at the bottom surface of button 416 of FFI 406. The base substrate 402 may be attached with an adhesive layer (not shown) or the base substrate 402 may be integrally formed with the buttons 416.
Microneedle patch 400 also includes a backing layer 408 attached to substrate 114 of FFI 406 at a lower surface 417 of the substrate and an upper surface of the backing layer. For example, the substrate of the FFI may be attached via an adhesive disposed on the top side of the backing layer 408. In some embodiments, the backing layer 408 includes an adhesive tape (e.g., a film or other thin structure including a polymer support/base layer and an adhesive layer (e.g., a pressure sensitive adhesive as known in the art)) disposed thereon in this manner, the FFI 406 can be directly attached to the backing layer 408.
The backing layer 406 includes a tab portion 410 that extends laterally away from a side of the substrate 414 to assist a user in handling the patch 400 without contacting the substrate or the microneedles 404. However, the microneedles 404 are advantageously disposed within the recesses 412 defined by the base 414 (and openings in the backing layer 408) to further protect the microneedles from unnecessary contact with any person or anything until the microneedles are intended to be inserted into the skin or another tissue surface.
In use, the array of microneedles 404 translate with the buttons 416 through/from the notches 412 for insertion. To apply the microneedle array 404, the button 416 is depressed downward and displaced from a pre-actuated position in which the microneedles 404 are disposed within the recesses 412 to an actuated position in which the microneedles 404 protrude from the recesses 412.
In the pre-actuated position, the button 416 is held in place within the base 414 by a latch 420 that extends laterally from the button 416 and is received in a first latch receptacle 418 in the housing. The latch 420 releasably retains the button 416 in a pre-actuated position, as shown in fig. 5A. The housing (base) also contains a second latch receptacle 422 configured to receive the latch 420 and to hold the button, preferably unreleasably, in the actuated position. The latch and socket may be configured such that a first minimum force on the button is effective to remove the latch from the first latch socket and displace the button toward the substrate and begin inserting the microneedle into the tissue surface, and a second minimum force on the button is effective to move the latch into the second latch socket and trigger a tactile and/or audible signal that sufficient force has been applied to the microneedle patch to achieve full insertion of the microneedle into the tissue surface. In some preferred embodiments, the first minimum force is less than the second minimum force.
In some other embodiments, a first minimum force on the button is effective to (i) remove the latch from the first latch receptacle and displace the button toward the substrate and begin inserting the microneedle into the tissue surface, and (ii) move the latch into the second latch receptacle and trigger a tactile and/or audible signal that sufficient force has been applied to the microneedle patch to achieve complete insertion of the microneedle into the tissue surface.
In some embodiments, the button 416, or at least a side surface thereof, has a material of a significantly different color than the base 414, so that a user can more easily or quickly identify when the button 416 has fully reached the actuated position.
The microneedle patch 400 optionally may further include an auxiliary feedback mechanism that indicates to the user that sufficient force has been applied to successfully deliver the microneedles to the tissue, similar to that described with respect to fig. 1. That is, in some cases, the force required to translate the button may be insufficient to insert the microneedle into the tissue. The secondary feedback mechanism may be triggered when sufficient force is applied to insert the microneedles.
In some embodiments, the microneedle patch 400 further comprises a release liner or other material (not shown) that covers the recess 412, for example by releasably adhering to the bottom of the backing layer 408, to further protect the microneedles prior to application of the patch. The release line will be removed prior to placing the microneedle patch against the skin.
In some alternative embodiments, the latch and latch socket features may be replaced or enhanced with other force setting/actuating mechanisms, such as plastic snaps, brittle fractures, plastic snap latch deformation, or snap into notches/recesses.
Microneedle storage system
As shown in fig. 3A-3C, the microneedle patch 100 may be housed on a tray 300 having an inner surface 302 defining a recessed area 304 therein. The recessed area 304 may be sized to receive and enclose the array of microneedles 104 in a non-contact manner. Tray 300 may also be releasably adhered to microneedle patch 100 to prevent movement of patch 100 within tray 300. That is, an adhesive layer (not shown) of the microneedle patch 100 may be releasably secured to the inner surface 302 of the tray 300. Because contact between the tray and the microneedle patch is substantially limited to the adhesive layer and/or backing, the integrity of the one or more microneedles is advantageously maintained during storage. In addition, the tray may also protect one or more microneedles from moisture, gas, or other contaminants that may degrade, shorten the shelf life, or reduce the effectiveness of the substance of interest.
In some embodiments, the tab portion 116 of the microneedle patch 100 may extend from the tray 300 to facilitate removal of the microneedle patch 100 from the tray. Tray 300 may also include a flange 306 to improve user access to microneedle patches 100 stored within tray 300.
The tray may take various shapes and sizes, such as a rectangular shape, a planar shape formed with a cover, or a partially elliptical shape. The tray may further include one or more additional features having various functions or for imparting a desired aesthetic appeal to the tray. For example, the tray may contain one or more depressions, holes, or cutouts. Such features may facilitate removal of the microneedle patch from the tray. The recessed area for receiving one or more microneedles may also be located in the tray such that at least a portion of the tab extends over the periphery of the tray.
Various materials may be used to make the trays provided herein, non-limiting examples of which include polymers (e.g., polytetrafluoroethylene (PTFE), fluorinated Ethylene Propylene (FEP), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), polyethylene or polypropylene), metallized polymers, elastomers, nonwoven and woven materials, paper-based materials, foams, metals or foils, and the like. In some embodiments, the tray may be formed of a composite material or a multi-layer material. For example, the multi-layer material may comprise one or more layers that impart desired structural properties and one or more layers that impart desired moisture and gas barrier properties.
The tray may be configured to hold a single patch or multiple patches (e.g., 2, 3,4, 5, 6, 7, 8, 10, 12, or 20 patches, or more or less). The tray may contain a plurality of recesses, wherein each recess corresponds to one of the microneedle patches. The tray may also contain one or more lines of weakness (e.g., perforations, score lines, etc.) so that portions of the tray may be separated from other portions of the tray. In some embodiments, the patch may be stored on one side of the tray, while in other embodiments, the patch may be stored on only one side of the tray (e.g., within recessed areas on both sides of the tray).
These trays alone may be sufficient to protect the patch prior to use, however, additional features may also be used. For example, one or more trays may be disposed in a flexible container (e.g., a bag) and/or a rigid container (e.g., a box). In some embodiments, a cover may be placed over the tray to protect the microneedle patch prior to use. Such a lid may be of the same or different material as the tray and may be sealed to the perimeter of the tray (i.e., using a heat seal, cold seal, or pressure sensitive adhesive). In one embodiment, the desiccant may be disposed in a recessed area or in a flexible or rigid container that houses the tray. The desiccant may alternatively or additionally be part of the tray itself. For example, the desiccant material may be comprised of a material (e.g., dispersed therein or coated thereon) that forms the structure of the tray. For example, the tray may be formed from desiccant polymers known in the art.
The tray may be formed using a variety of different methods, non-limiting examples of which include various molding methods (e.g., thermoforming, injection molding, stamping, casting), 3D printing, and the like.
In some embodiments, as shown in fig. 10A-10C, a microneedle patch 400 as described with respect to fig. 6A-6B may be folded in half and stored in a sealed pouch 700. In some embodiments, as shown in fig. 10A, the base substrate 408 of the microneedle patch 400 may be folded at the point where the feedback indicator 406 is attached to the base substrate 408 and again near the interface between the tab portion 410 and the base substrate 408. The result is a compact patch 400 that may be more easily contained in a compact container or bag.
In an embodiment, a pouch material (e.g., foil) 702 may be adhered to the microneedle patch 400. That is, the microneedle patch 400 may have an adhesive layer (not shown) on the bottom side of the backing layer 408. Thus, the pouch material 702 may adhere to the adhesive surface of the backing layer 408 and fold upon itself to form the pouch 700. In some embodiments, the pouch material 702 may completely surround the microneedle patch 400, i.e., the pouch 700 is formed entirely of the pouch material 702. In other embodiments, the pouch material 702 surrounds the microneedle patch 400 on all sides except the side covered with the cover 704. The cover 704 may be sealed or otherwise attached to the bag material 702.
As shown in fig. 10B, a plurality of trays 700 may be arranged in an array to form a packing unit 710. The tray 700 within each packaging unit 710 may be releasably attached to each adjacent tray 700 in the packaging unit 710. For example, the edge 706 of each tray 700 can be defined by a perforation line in the shared sheet material (which forms the cover 704) such that the respective trays 700 can be separated from one another along the edge 706. Each tray 700 may also include an opening tab 708 to facilitate removal of the cover 704. In some embodiments, multiple packaging units 710 may be stacked and stored in a box 712 or other storage container for long-term storage and/or transport of microneedle patches.
In other embodiments, as shown in fig. 11A-11B, a microneedle patch 100 as described with respect to fig. 1 may be placed in a tray 800 sized and shaped to receive the microneedle patch 100. The microneedle patch 100 may be located within a cavity 802 defined within a base portion 804 of the tray 800. In some embodiments, the bottom 806 of the cavity 802 is angled so that the tab portion 116 of the microneedle patch 100 can be easily grasped to remove the patch 100 from the tray 800. That is, the angled bottom 806 of the cavity 802 may angle the tab 116 of the microneedle patch 100 in an upward direction such that the tab is positioned near the opening of the cavity 802. In some embodiments, the tray 800 may be sealed with a lid 808 that covers at least the cavity 802. However, it is preferable that the cover 808 covers the entire base 804 of the tray 800. The cover 808 may be formed from a foil or another suitable film material that may be peeled from the tray 800 when the patch 100 is ready for use.
As shown in fig. 11A, a plurality of trays 800 may form a packaging unit 810, with an edge 812 of one tray 800 releasably attached to an edge 812 of each adjacent tray 800. In some embodiments, releasably attached edge 812 is defined by a perforation line in the shared sheet material, i.e., the sheet material used to form lid 808 of tray 800. The packaging unit 810 may be stacked and stored in a box or other storage container, similar to the packaging unit 710.
Microneedle preparation
Various substances can be formulated for delivery to biological tissue using the microneedle patches and methods of the present invention. The microneedles may be formed from one or more substances of interest and one or more excipients. As used herein, the term "substance of interest" includes active pharmaceutical ingredients, allergens, vitamins, cosmetics, cosmeceuticals, markers (e.g., colored dyes, inks, pigments, or radioactive dyes or markers), and other materials that are desired to be introduced into the skin or another biological tissue. In some embodiments, the substance of interest is a prophylactic, therapeutic or diagnostic agent that can be used in medical or veterinary applications. In some embodiments, the substance of interest is a bioactive agent, which may be referred to herein as an API, which may be a prophylactic or therapeutic substance. The API may be selected from the group consisting of suitable proteins, peptides and fragments thereof, which may be naturally occurring, synthetic or recombinantly produced. In some embodiments, the substance of interest comprises a vaccine.
The substance of interest may be included in the formulation along with one or more excipients and other additives used in pharmaceutical formulations. Non-limiting examples of such excipients include stabilizers, buffers, bulking or bulking agents, adjuvants, surfactants, disintegrants, antioxidants, solubilizers, lyoprotectants, antimicrobial agents, anti-adherent agents, colorants, lubricants, viscosity enhancers, glidants, preservatives. Excipients may be those found in existing pharmaceutical products (e.g., those listed in inactive ingredients of the FDA in approved pharmaceutical product databases) or may be novel and may effectively perform more than one function (e.g., sugars may be used as stabilizers and bulking agents, buffers may be used to buffer pH and protect substances of interest from oxidation). One or more selected excipients desirably improve the stability of the substance of interest during drying and storage of the microneedle patch.
Application method
The microneedle patches provided herein may be administered by themselves or by another individual (e.g., a parent, guardian, minimally trained medical personnel, professionally trained medical personnel, and/or others). Unlike prior art microneedle systems, the microneedle patches provided herein may be handled and applied directly by the person applying the patch without the need to use an applicator to apply the required force/pressure.
Accordingly, embodiments provided herein further include a simple and effective method of administering a substance of interest with a microneedle patch. The method may comprise identifying the site of application and preferably disinfecting (e.g., wiping with alcohol) the area prior to application of the microneedle patch. The site of application may be dried, if desired, prior to application of the microneedle patch. The patch may be removed from the tray or pouch where it is releasably secured by grasping the tab portion of the patch between the thumb and finger and peeling the patch from the tray or pouch. The patch is then applied to the patient's skin/tissue and the patch is manually pressed into the patient's skin/tissue (e.g., using a thumb or finger) by applying sufficient pressure to insert one or more microneedles into the patient's skin/tissue. After the application is complete, the patch may be removed from the patient's skin/tissue by manually grasping the tab portion (e.g., between the thumb and finger), peeling the patch from the patient's skin/tissue, and discarding the patch.
Fig. 6A-7C depict the application process of the microneedle patch described herein and dissolution of the microneedles within the patient's skin/tissue after insertion. For example, as shown in fig. 6A and 7A, a microneedle patch may be inserted into the skin/tissue of a patient such that a majority of the microneedles are disposed below the surface of the skin/tissue. When the microneedles begin to dissolve, as shown in fig. 6B and 7B, the tip portions of the microneedles may become fully dissolved and dispersed within the tissue while the base portions of the microneedles remain intact. However, at the point where the patch is removed from the patient's skin/tissue, the microneedle may be completely dissolved within the patient's skin/tissue, as shown in fig. 6C and 7C.
In some embodiments, the user may use one or more indicators before, during, and/or after application of the microneedle patch. Such indicators may be elements incorporated into the microneedle patch that provide a detectable signal, or may be generated by a user performing one or more actions, such as evaluating the microneedle patch or the patient's skin/tissue after application.
The user may evaluate various indicators during application of the patch to signal whether the patch has been properly applied and/or may be removed. For example, in some embodiments, the indicator provides a signal that a predetermined threshold force has been reached or that the microneedle has penetrated/pierced the skin of the patient, indicating that the user may cease applying pressure to the patch. In some other embodiments, the indicator may provide a signal at the end of the compression period, i.e., the period after insertion during which the patient or user must continue to apply pressure to the microneedle patch. The hold down period may have a duration of between 0 seconds and 120 seconds, for example between 0 seconds and 60 seconds, between 0 seconds and 30 seconds, or between 0 seconds and 10 seconds.
The above-described indicators and feedback can also be used to provide evidence that a microneedle patch has been used, and can be helpful if the patch is not properly discarded after use (i.e., thereby avoiding attempts to reuse the patch, which would result in ineffective treatment or potential exposure to biohazardous materials that have been contaminated with the bodily fluids of previous patients). Evidence of the use of microneedle patches is particularly helpful because microneedles are small structures that are barely visible to the naked eye.
Manufacturing
Methods and systems for manufacturing the microneedle patches are also provided. Such a method is preferably performed under the lowest ISO 7 (10,000 grade) process or ISO 5 (100 grade) process. In some embodiments, the fabrication of solid dissolvable microneedles involves filling the negative mold of the microneedles with an aqueous or non-aqueous casting solution of the substance of interest, and then drying the casting solution to provide solid microneedles. The filling and drying steps may be repeated with the same or different casting solutions. In some embodiments, droplets of casting solution may be deposited onto the mold or a portion thereof. The droplets may then be dispersed throughout the mold.
In some embodiments, the mold contains a single opening over which a droplet can be deposited and which will spread over all microneedle cavities extending from the opening. In other embodiments, as shown in fig. 8, a mold 500 may have several openings 502, each defining a plurality of microneedle cavities 504 therein. Droplets 506 of casting solution may be deposited onto each section 502 of the mold 500. The droplets 506 may have the same or different casting solutions. That is, in some cases, each of the droplets 506 has the same casting solution, such that the resulting microneedle patch has an array of microneedles all having the same formulation. However, in other cases, the droplets 506 may have different casting solutions such that the resulting microneedle array contains microneedles having two or more different formulations.
An exemplary microneedle patch 600 formed from a segmented mold, such as the mold of fig. 8, is depicted in fig. 9. The microneedle patch 600 may include a base substrate 602 and an array 604 of segmented microneedles extending therefrom. Similar to the microneedle patch 100 described with respect to fig. 1, the patch 600 may also include a backing layer 606 to which the base substrate 602 is attached and a tab portion 608 extending from the backing layer 606.
Although fig. 8-9 depict a mold and microneedle patch having three sections, it should be understood that any number of sections are possible. For example, the mold may have 2, 4,5, 6, 8, or 10 sections, or any other desired number thereof.
In some embodiments, it may be desirable to use a multi-step casting process to form the microneedles and base substrate. For example, the tips of the microneedles may be partially filled in a first step with a casting solution comprising a substance of interest (and one or more excipient (matrix) materials), and then subjected to one or more subsequent filling steps with a casting solution of an expanding material (e.g., sodium carboxymethyl cellulose, polyvinyl alcohol, sugar, gelatin, polyvinylpyrrolidone (PVP), cellulose, and/or other matrix materials, including non-dissolving materials, such as urethane or acrylic polymers), with or without the same or different substance of interest. After filling and at least partially drying the microneedles in the negative mold, an adhesive layer and a backing layer may be applied to the base substrate prior to removing the microneedles from the mold. In some embodiments, the adhesive layer and/or backing layer is preformed prior to application to the base substrate, while in other embodiments, the adhesive layer and/or backing layer may be formed directly in-line. After at least partially drying the microneedles, the microneedles may be removed from the mold. For example, the microneedles may be removed from the mold before being completely dried (e.g., while still in a rubbery state), but when strong enough to be peeled off, and then further dried once removed from the mold to further cure/harden the microneedles. In such embodiments, the microneedles may be dried before or after packaging.
The microneedle patch may then be attached to the tray and subjected to one or more additional packaging steps. For example, the microneedle patch may be applied to a tray and packaged under sterile conditions in a foil pouch with a desiccant.
Microneedle wear time indicator
The feedback indicator may also provide information to the user (and/or patient) that the microneedle patch has been worn for a sufficient amount of time (i.e., the substance of interest has been released into the target tissue). Such indicators may be particularly useful for providing user confidence that the substance of interest is effectively delivered, particularly where delivery of the substance of interest depends on insertion and dissolution of the microneedle or coating. The indicator may measure all or part of the microneedle dissolution, depending on whether all or part of the microneedle dissolution is required to deliver an effective amount of the substance of interest. For example, by measuring complete dissolution, the indicator may signal to the user that the microneedle patch may be removed from the patient's skin. In some cases, it may be useful for the indicator to signal partial dissolution, or otherwise signal that user interaction with the microneedle patch is necessary or desirable, if partial dissolution would be sufficient to provide an effective amount of the substance of interest.
An exemplary wear time indicator 1000 is shown in fig. 12. The Wear Time Indicator (WTI) 1000 may provide a visual indication to the user that the microneedle patch has been worn on the patient's skin for a sufficient period of time. In an embodiment, WTI 1000 comprises a dye blister 1002 and a core assembly 1004. Dye blister 1002 may include a depressible housing 1006 containing a rupturable dye reservoir 1008. The depressible housing 1006 may include a substantially flat portion 1012 and a deformable portion 1014 beneath which the dye reservoir 1008 is disposed. In use, a patient or user may depress the deformable portion 1014 of the depressible housing 1006 with sufficient force to rupture the dye reservoir 1008 therein. After the dye reservoir 1008 has ruptured, the dye within the dye reservoir 1008 may be transferred to the core assembly 1004 at a controlled rate through a channel 1016 in the bottom 1010 of the depressible housing 1006. That is, the size of the channels 1016 may be selected such that the dye diffuses at a predetermined controlled rate.
The core assembly 1004 may include a wicking film 1018 configured to absorb dye from the dye blister 1002. The wicking film can be mounted on the backing 1020 and covered by the protective layer 1022. In some embodiments, the backing 1020 itself may be formed of an adhesive material such that the wicking film 1018 may be secured directly to the adhesive surface of the backing 1020. In other embodiments, the wicking film 1018 is attached to the backing 1020 with additional adhesive (not shown) or the protective layer 1022 is effective to hold the wicking film 1018 in place on the backing 1020. The backing layer 1020 may also contain an additional adhesive layer (not shown) on the side opposite the wicking film 1018 to secure the wear time indicator to a microneedle patch, such as the microneedle patches described herein.
In an embodiment, the wicking film 1018 has a central portion 1024 on which dye from the dye blister 1002 is initially deposited, and a peripheral portion 1026 along which dye will travel in a given period of time. In some embodiments, as shown in fig. 12, the central portion 1024 is circular and is located below a similarly sized and shaped opening 1028 in the protective layer 1022 of the core assembly 1004. As dye from the dye reservoir 1012 passes through an opening 1028 in the protective layer 1022 onto the central portion 1024 of the wicking film 1018. As the central portion 1024 becomes saturated with dye, the dye will begin to travel along the peripheral portion 1026 of the wicking film 1018 disposed in a spiral-like configuration around the central portion 1024. Over time, the dye will travel around the peripheral portion 1026 of the wicking film 1018, where the distance that the dye has traveled or the portion of the wicking film 1018 on which the dye has traveled (i.e., the amount of dye that has been absorbed) corresponds to the amount of time that the microneedle patch has been worn. For example, as shown in fig. 13A-13D, the wicking film 1018 may be free of dye prior to rupture of the dye reservoir 1012 (fig. 13A), and after rupture of the reservoir 1012, the dye will cover a portion of the central portion 1024 (fig. 13B) and the peripheral portion 1026 (fig. 13C). At the end of the specified wear time, the dye will cover the entire peripheral portion (fig. 13D).
The upper portion 1008 of the dye blister 1002 may also include one or more windows 1030 through which one or more regions of the wicking film 1018 are visible. The location of the visible region or window 1030 of the wicking film 1018 may depend on the desired wear time of the patch. For example, if the optimal wear time of the patch is 10 minutes, the dye may take 10 minutes to be fully absorbed by the wicking film 1018. In some embodiments, dye blister 1002 has a single window 1030 for indicating the final wear time of the microneedle patch, as shown in fig. 13A-13D. In other embodiments, as shown in fig. 12, dye blister 1002 may have at least one additional window 1030 positioned at an intermediate location along peripheral portion 1026 of wicking film 1018 to indicate a shorter wear time than the total wear time. For example, if the total wear time is 10 minutes, a first window 1030 may be placed at the end of the peripheral portion 1026 of the wicking film 1018 to indicate a complete 10 minute wear time, and a second window 130 may be placed to indicate a shorter wear time, e.g., 1 minute, 3 minutes, 5 minutes, etc. In an embodiment, the wearing time is from 30 seconds to 10 minutes, preferably 30 seconds, 1 minute, 3 minutes or 5 minutes.
Modifications and variations of the methods and apparatus described herein will be readily apparent to those skilled in the art from the foregoing detailed description. Such modifications and variations are intended to fall within the scope of the appended claims.
Claims (66)
Applications Claiming Priority (3)
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|---|---|---|---|
| US202263405932P | 2022-09-13 | 2022-09-13 | |
| US63/405,932 | 2022-09-13 | ||
| PCT/US2023/032664 WO2024059152A2 (en) | 2022-09-13 | 2023-09-13 | Microneedle patch with force-feedback indicator |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN120265352A true CN120265352A (en) | 2025-07-04 |
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|---|---|---|---|
| CN202380068692.0A Pending CN120265352A (en) | 2022-09-13 | 2023-09-13 | Microneedle patch with force feedback indicator |
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| EP (1) | EP4587094A2 (en) |
| JP (1) | JP2025530880A (en) |
| CN (1) | CN120265352A (en) |
| WO (1) | WO2024059152A2 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8267889B2 (en) * | 2004-11-18 | 2012-09-18 | 3M Innovative Properties Company | Low-profile microneedle array applicator |
| AU2008209537B2 (en) * | 2007-01-22 | 2013-01-31 | Corium Pharma Solutions, Inc. | Applicators for microneedle arrays |
| RU2719927C2 (en) * | 2013-09-30 | 2020-04-23 | Джорджия Тек Рисёч Корпорейшн | Microneedle patches, systems and methods |
| EP3134149A4 (en) | 2014-04-24 | 2017-12-27 | Georgia Tech Research Corporation | Microneedles and methods of manufacture thereof |
| EP3283158B1 (en) | 2015-04-17 | 2023-04-05 | Georgia Tech Research Corporation | Drug delivery devices having separable microneedles |
| CA3115572A1 (en) | 2017-10-11 | 2019-04-18 | Georgia Tech Research Corporation | Separable microneedle arrays for sustained release of drug |
| US20230028295A1 (en) * | 2019-12-18 | 2023-01-26 | Uprax Microsolutions B.V. | Applicators and methods for applying a microneedle patch to a skin of a subject, and microneedle patches |
-
2023
- 2023-09-13 CN CN202380068692.0A patent/CN120265352A/en active Pending
- 2023-09-13 WO PCT/US2023/032664 patent/WO2024059152A2/en not_active Ceased
- 2023-09-13 JP JP2025539624A patent/JP2025530880A/en active Pending
- 2023-09-13 EP EP23783634.1A patent/EP4587094A2/en active Pending
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| JP2025530880A (en) | 2025-09-17 |
| EP4587094A2 (en) | 2025-07-23 |
| WO2024059152A3 (en) | 2024-05-23 |
| WO2024059152A2 (en) | 2024-03-21 |
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