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EP4587094A2 - Timbre à micro-aiguilles avec indicateur de retour de force - Google Patents

Timbre à micro-aiguilles avec indicateur de retour de force

Info

Publication number
EP4587094A2
EP4587094A2 EP23783634.1A EP23783634A EP4587094A2 EP 4587094 A2 EP4587094 A2 EP 4587094A2 EP 23783634 A EP23783634 A EP 23783634A EP 4587094 A2 EP4587094 A2 EP 4587094A2
Authority
EP
European Patent Office
Prior art keywords
microneedle patch
button
microneedles
microneedle
base
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
EP23783634.1A
Other languages
German (de)
English (en)
Inventor
Devin V. Mcallister
Charles M. QUILLIAN
Rolando H. GALVEZ-GALLARDO
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.)
Micron Biomedical Inc
Original Assignee
Micron Biomedical Inc
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 Micron Biomedical Inc filed Critical Micron Biomedical Inc
Publication of EP4587094A2 publication Critical patent/EP4587094A2/fr
Pending legal-status Critical Current

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
    • 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
    • A61M2037/0046—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

Definitions

  • the WTI includes a dye blister and a wick assembly, wherein the dye blister has a burstable dye reservoir configured to release a dye into the wick assembly upon application of a force to the microneedle patch to effect insertion of the microneedles.
  • the position of the dye within the wick assembly corresponds to the wear time.
  • this favorable handling tab position may be achieved by a design in which the handling tab is folded over a top of the of the microneedle patch within the sealed tray and partially unfolds itself upon removal of the foil or other film from over the cavity.
  • a packaging system is provided that includes comprising a plurality of these microneedle patch packaging units, wherein an edge of the 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 edges defined by a line of perforations in a shared sheet material.
  • FIGS. 1 A and IB are perspective and exploded views, respectively, of a microneedle patch with a FFI, according to one or more embodiments of the present disclosure.
  • FIG. 2A is a side view of a microneedle patch with a FFI, 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. 1 IB is a perspective view of an opened one of the microneedle packaging units shown in FIG. 11A, with the microneedle patch disposed with the cavity of the tray (with the cover material removed), according to one or more embodiments of the present disclosure.
  • the microneedle patches include an array of microneedles extending from a base substrate, which is connected to other components facilitating handling and insertion of the microneedles.
  • Those components typically include a tape layer comprising an adhesive face and a handling tab, and may further include a force feedback indicator (FFI) or a wear time indicator (WTT).
  • FFI and WTT are not electronic. Instead, they are operate mechanically, and typically are made from relatively inexpensive polymeric parts that can be produced in high-volume manufacturing processes.
  • the microneedles are solid microneedles that include a substance of interest, such as an active pharmaceutical ingredient (API), which becomes solubilized in vivo following insertion of the microneedle into a biological tissue, e.g., into the skin of a patient.
  • a substance of interest such as an active pharmaceutical ingredient (API)
  • API active pharmaceutical ingredient
  • the substance of interest may be mixed in a water soluble matrix forming the solid microneedle extending from the base substrate, or the substance of interest may be in the form of a coating on a microneedle sub-structure extending from the base substrate.
  • FIG. 1 An exemplary microneedle patch with a FFI and a plurality of solid microneedles is illustrated in FIG. 1.
  • the patch 100 includes a base substrate 102 with a plurality of microneedles 104.
  • the plurality of microneedles 104 is attached to a FFI 106.
  • the microneedles 104 and FFI 106 may be attached to a backing layer 108 via an opening 110 therein. That is, the backing layer 108 may include an opening 110 sized and shaped to receive the plurality of microneedles 104 and FFI 106 within the opening 110.
  • the tab portion 116 may be sized and shaped to permit a person to manually hold the tab portion 116 (e.g., between a thumb and finger).
  • the tab portion 116 is illustrated in FIG. 1 as extending laterally and asymmetrically from the backing layer 108, other shapes and sizes are also possible.
  • 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 function to adhere the patch to a tray or container covering the plurality or microneedles during shipping and storage, as well as for disposal after its use.
  • the tab portion 116 is substantially free of the adhesive layer, enabling a person handling and applying the patch to do so without contacting the adhesive layer.
  • the adhesive layer may be disposed over substantially all of a side of the backing layer 108, including the tab portion 116.
  • a cover portion (not shown) may be disposed over the adhesive layer over the tab portion 116 so that a person holding the patch 100 by the tab portion does not contact much of the adhesive layer.
  • 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, where the side surface 136 is visible in the pre-actuated position and substantially not visible in the actuated position.
  • the button 120 may initially sit proud above the backing layer 108 and the base 118 of the feedback indicator.
  • the button 120 may move downward into the central portion 122 of the base 118.
  • the side surface 136 may be formed of a material having a different color from the rest of the feedback indicator 106, which may help the user to better identify when the button 120 has fully translated from the pre-actuated position to the actuated position, indicating that the plurality of microneedles 104 have been at least partially inserted into the tissue.
  • the FFI 106 also includes a secondary mechanism for providing a user with feedback to assist with the proper and effective use of the microneedle patch.
  • the translating the button 120 into the actuated position may not be sufficient to fully insert the microneedles 104 into the tissue. That is, actuating the button 120 from the preactuated position to the actuated position may only be sufficient to penetrate the tissue and partially insert the microneedles 104, requiring additional force to fully insert the microneedles 104 into the skin.
  • the secondary feedback may be provided in a variety of forms or combinations, including tactile (e.g., detectable sensation felt by the person administering the patch or the patient), audible (e.g., the presence, absence, or change of sound).
  • the feedback may be provided to a variety of “users”, including but not limited to the person (e.g., a patient) to whom the microneedle patch is applied, as well as any other person (health care worker, caregiver, parent, guardian) applying the microneedle patch to the person.
  • the person e.g., a patient
  • any other person health care worker, caregiver, parent, guardian
  • the FFI indicates to the user the amount of force and/or pressure applied to the patch during its administration.
  • the indicator is configured to provide a signal when a force applied to the patch by a user (in the course of applying the patch to a patient’s skin to insert the microneedles into the patient’s skin) meets or exceeds a predetermined threshold.
  • the predetermined threshold may be the minimum force or some amount greater than the minimum force that is required for a particular microneedle patch to be effectively applied to a patient’s skin. That is, it is the force needed to cause the microneedles to be properly, e.g., substantially, inserted into a patient’s skin.
  • the microneedle patch 400 includes a base substrate 402 with an array of microneedles 404.
  • the base substrate 402 is attached to only to the button 416 of the FFI 406 at a bottom surface of the button 416.
  • the base substrate 402 may be attached with an adhesive layer (not show) or the base substrate 402 may be integrally formed with the button 416
  • the backing layer 406 includes a tab portion 410 which extends laterally away from one side of the base 414 to help a user to handle the patch 400 without contacting the base or the microneedles 404.
  • the microneedles 404 advantageously are disposed within a recess 412 defined with the base 414 (and an opening in the backing layer 408) to further protect the microneedles from unwanted contact with anyone or anything until an intended insertion of the microneedles into skin or another tissue surface.
  • the button 416 or at least its side surfaces, have a distinctly different color material from the base 414 so that a user may more easily or more quickly identify when the button 416 has fully reached the actuated position.
  • the microneedle patch 100 may be housed on a tray 300 having an inner surface 302 defining a recessed region 304 therein.
  • the recessed region 304 may be dimensioned to receive and enclose the array of microneedles 104 in a non-contacting manner.
  • the tray 300 may be also be releasably adhered to the microneedle patch 100 to prevent movement of the patch 100 within the tray 300. That is, the adhesive layer (not shown) of the microneedle patch 100 may be releasably secured to the inner surface 302 of the tray 300.
  • the tab portion 116 of the microneedle patch 100 may extend from the tray 300 to ease removal of the microneedle patch 100 from the tray.
  • the tray 300 may also include a ledge 306 to improve user access to the microneedle patch 100 stored within the tray 300.
  • the trays may formed using a variety of different methods, non-limiting examples of which include various molding methods (e.g., thermoforming, injection molding, stamping, casting), 3-D printing, and the like.
  • various molding methods e.g., thermoforming, injection molding, stamping, casting
  • 3-D printing and the like.
  • the microneedle patches 400 as described with respect to FIGS. 6A-6B may be folded in half and stored in a sealed pouch 700.
  • 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 proximate to the interface between the tab portion 410 and the base substrate 408. The result is a compact patch 400 that can be more easily contained in a compact container or pouch.
  • the tray 800 may be sealed with a lid 808 that covers at least the cavity 802. However, it is preferred that the lid 808 covers the entire base 804 of the tray 800.
  • the lid 808 may be formed of foil or another suitable film material that may be pealed away from the tray 800 when the patch 100 is ready for use.
  • a plurality of trays 800 may form a packaging unit 810 where the edge 812 of one tray 800 is releasably attached to the edge 812 of each adjacent tray 800.
  • the releasably attached edges 812 are defined by a line of perforations in a shared sheet material, i.e., a sheet material used to form the tray 800 lids 808.
  • the packaging units 810 may be stacked and stored in boxes or other storage containers, similar to packaging units 710.
  • the microneedles may be formed of one or more substances of interest and one or more excipients.
  • the term “substance of interest” includes active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, markers (e.g., colored dyes, inks, pigments, or radiological dyes or markers), and other materials that are desirable to introduce into skin or another a biological tissue.
  • the substance of interest is a prophylactic, therapeutic, or diagnostic agent useful in medical or veterinary applications.
  • the substance of interest is a bioactive agent, which may be prophylactic or therapeutic substance, which may be referred to herein as an API.
  • the API may be selected from suitable proteins, peptides and fragments thereof, which can be naturally occurring, synthesized or recombinantly produced.
  • the substance of interest comprises a vaccine.
  • microneedle patches provided herein may be self-administered or administered by another individual (e.g., a parent, guardian, minimally trained healthcare worker, expertly trained healthcare worker, and/or others). Unlike prior art microneedle systems, the microneedle patches provided herein may be directly handled and administered by the person applying the patch without requiring use of an applicator to apply the required force/pressure. Thus, embodiments provided herein further include a simple and effective method of administering a substance of interest with a microneedle patch. The method may include identifying an application site and, preferably, sanitizing the area prior to application of the microneedle patch (e.g., using an alcohol wipe).
  • the application site may be allowed to dry before application of the microneedle patch.
  • the patch may be removed from the tray or pouch in which 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 then is applied to the patient’s skin/tissue and manually pressed into the patient’s skin/tissue (e.g., using the thumb or finger) by applying a sufficient pressure to insert the one or more microneedles into the patient’s skin/tissue.
  • 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 off the patient’s skin/tissue, and discarding the patch.
  • a user may use one or more indicators prior to, during, and/or after administration of the microneedle patch.
  • Such indicators may be elements incorporated into the microneedle patch that provide a detectable signal or may result from the user performing one or more actions, such as evaluating the microneedle patch or the patient's skin/tissue following administration.
  • the manufacture of solid, dissolvable microneedles includes filling a 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 the solid microneedles.
  • the filling and dry step may be repeated with the same or a different casting solution.
  • droplets of the casting solution may be deposited onto the mold, or a portion thereof. The droplets may then be dispersed throughout the mold.
  • the mold contains a single opening onto which a droplet can be deposited, and said droplet will disperse across all of the microneedle cavities extending from said opening.
  • the mold 500 may have several openings 502, each opening defining a plurality of microneedle cavities 504 therein.
  • a droplet 506 of a casting solution may be deposited onto each segment 502 of the mold 500.
  • the droplets 506 may be of the same or different casting solutions. That is, in some instances, each of the droplets 506 are of the same casting solution such that the resulting microneedle patch has an array of microneedles all having the same formulation.
  • FIGS. 8-9 depict a mold and microneedle patch having three segments, it would be understood that any number of segments may be possible.
  • the mold could have 2, 4, 5, 6, 8, or 10 segments, or any other desirable number thereof.
  • Feedback indicators 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., that the substance of interest has been released into the target tissue). Such indicators may be especially useful to provide a user confidence that the substance of interest was effectively delivered, particularly where delivery of the substance of interest is dependent upon insertion and dissolution of the microneedles or coating.
  • the indicator may measure full or partial microneedle dissolution, depending on whether full or partial microneedle dissolution is needed for delivery of an effective amount of the substance of interest. For example, by measuring full dissolution, the indicator can signal to the user that the microneedle patch can be removed from the patient's skin. It may also be useful in some circumstances for the indicator to signal partial dissolution if the partial dissolution would be sufficient to provide an effective amount of the substance of interest or to otherwise signal that user interaction with the microneedle patch is necessary or desirable.
  • the wear time indicator (WTI) 1000 may provide the user with a visible indication that the microneedle patch has been worn on the patient's skin for a sufficient period of time.
  • the WTI 1000 includes a dye blister 1002 and a wick assembly 1004.
  • the dye blister 1002 may include a depressible casing 1006 containing a burstable dye reservoir 1008.
  • the depressible casing 1006 may include a substantially flat portion 1012 and a deformable portion 1014 under which the dye reservoir 1008 is placed. In use, the patient or user may depress the deformable portion 1014 of the depressible casing 1006 with enough force to burst the dye reservoir 1008 therein.
  • the dye will travel around the peripheral portion 1026 of the wicking membrane 1018, where the distance the dye has traveled, or the portion of the wicking membrane 1018 onto which the dye has traveled, (i.e., the amount of dye that has been absorbed) corresponds with an amount of time that the microneedle patch has been worn.
  • the wicking membrane 1018 may be free of dye before the dye reservoir 1012 is broken (FIG. 13A), and after the reservoir 1012 is broken the dye will cover the center portion 1024 (FIG. 13B) and part of the peripheral portion 1026 (FIG. 13C). At the end of the designated wear time, the dye will have covered the entire peripheral portion (FIG. 13D).

Landscapes

  • 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

Un timbre à micro-aiguilles qui comprend un réseau de micro-aiguilles ; un substrat de base à partir duquel s'étendent les micro-aiguilles ; et un indicateur de rétroaction de force (FFI) fixé au substrat de base. Le FFI comprend une base et un bouton, qui a une surface supérieure et une surface latérale, le bouton étant conçu pour effectuer une translation d'une position pré-actionnée à une position actionnée à l'intérieur de la base, la surface latérale étant sensiblement visible dans la position pré-actionnée et sensiblement non visible dans la position actionnée. La surface latérale a une couleur différente de celle de la surface supérieure et/ou de la base, ce qui facilite la confirmation visuelle de l'état d'actionnement du bouton, ce qui peut aider à indiquer si le timbre à micro-aiguilles est a été utilisé ou est prêt à être utilisé. Le FFI peut être conçu pour fournir une confirmation tactile, audible et visuelle d'une force suffisante appliquée à un timbre à micro-aiguilles pour effectuer l'insertion des micro-aiguilles.
EP23783634.1A 2022-09-13 2023-09-13 Timbre à micro-aiguilles avec indicateur de retour de force Pending EP4587094A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263405932P 2022-09-13 2022-09-13
PCT/US2023/032664 WO2024059152A2 (fr) 2022-09-13 2023-09-13 Timbre à micro-aiguilles avec indicateur de retour de force

Publications (1)

Publication Number Publication Date
EP4587094A2 true EP4587094A2 (fr) 2025-07-23

Family

ID=88241460

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23783634.1A Pending EP4587094A2 (fr) 2022-09-13 2023-09-13 Timbre à micro-aiguilles avec indicateur de retour de force

Country Status (5)

Country Link
EP (1) EP4587094A2 (fr)
JP (1) JP2025530880A (fr)
CN (1) CN120265352A (fr)
CA (1) CA3267298A1 (fr)
WO (1) WO2024059152A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025222045A1 (fr) * 2024-04-17 2025-10-23 Micron Biomedical, Inc. Dispositifs à micro-aiguilles pour vaccinations à délivrance et acceptation améliorées

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006055795A1 (fr) * 2004-11-18 2006-05-26 3M Innovative Properties Company Applicateur de jeux de micro-aiguilles a profil bas
AU2008209537B2 (en) * 2007-01-22 2013-01-31 Corium Pharma Solutions, Inc. Applicators for microneedle arrays
ES2928783T3 (es) 2013-09-30 2022-11-22 Georgia Tech Res Inst Parches y sistemas de microagujas
JP6934721B2 (ja) 2014-04-24 2021-09-15 ジョージア テック リサーチ コーポレイション マイクロニードル及びその製造方法
EP3283158B1 (fr) 2015-04-17 2023-04-05 Georgia Tech Research Corporation Dispositifs d'administration de médicament avec des micro-aiguilles séparables
US11730937B2 (en) 2017-10-11 2023-08-22 Georgia Tech Research Corporation Separable microneedle arrays for sustained release of drug
WO2021121589A1 (fr) * 2019-12-18 2021-06-24 Uprax Microsolutions B.V. Applicateurs et procédés d'application d'un timbre à micro-aiguilles sur la peau d'un sujet, et timbres à micro-aiguilles

Also Published As

Publication number Publication date
CA3267298A1 (fr) 2024-03-21
WO2024059152A3 (fr) 2024-05-23
WO2024059152A2 (fr) 2024-03-21
CN120265352A (zh) 2025-07-04
JP2025530880A (ja) 2025-09-17

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