Carrier Element for Micro-Needles, and Micro-Needle Array Device

20230146417 · 2023-05-11

    Inventors

    Cpc classification

    International classification

    Abstract

    A carrier element for micro-needles for forming a micro-needle array has a plate-like base element. Mounting elements for respectively connecting to a micro-needle of the micro-needle array are provided on a front side of the base element. Connecting elements are also provided, in particular on the front side of the mounting elements. The connecting elements are formed in such a way that they have an undercut in the longitudinal direction such that the needles are reliably connected to the mounting elements.

    Claims

    1. A carrier element for microneedles for forming a microneedle array, comprising: a plate-shaped base element, mounting elements provided on a front side of the base element, each for connecting to one micro-needle of the micro-needle array, and connecting elements provided in particular on the front sides of the mounting elements, wherein the connecting elements have an undercut in the longitudinal direction.

    2. The carrier element for microneedles for forming a microneedle array according to claim 1, the connecting elements comprise, at least in part, protrusions extending in the longitudinal direction.

    3. The carrier element for microneedles for forming a microneedle array according to claim 2, wherein the protrusions comprise a cross section taper transverse to the longitudinal direction for forming the undercut.

    4. The carrier element for microneedles for forming a microneedle array according to claim 3, wherein the protrusions comprise an in particular circumferential groove for forming a cross section taper.

    5. The carrier element for microneedles for forming a microneedle array according to claim 2, wherein the protrusions are formed in a mushroom shape.

    6. The carrier element for microneedles for forming a microneedle array according to claim 1, wherein the connecting elements comprise, at least in part, one or a plurality of channels extending into the mounting element.

    7. The carrier element for microneedles for forming a microneedle array according to claim 6, wherein the channels do, at least in part, not extend in the longitudinal direction.

    8. The carrier element for microneedles for forming a microneedle array according to claim 6, wherein the channels present, at least in part, a cross section enlargement for forming an undercut.

    9. The carrier element for microneedles for forming a microneedle array according to claim 6, wherein, starting from the front side of the mounting element, the channels extend, at least in part, towards the front side of the base element.

    10. The carrier element for microneedles for forming a microneedle array according to claim 6, wherein the channels extend, at least in part, from the front side of the mounting elements towards the rear side of the base element.

    11. The carrier element for microneedles for forming a microneedle array according to claim 1, wherein a holder for holding the carrier element by an applicator is provided on a rear side of the base element.

    12. The carrier element for microneedles for forming a microneedle array according to claim 1, wherein a connecting surface, in particular an adhesive surface for a packaging element, in particular a packaging film, is provided in an edge region on the front side and/or the rear side of the base element.

    13. A microneedle array with a carrier element according to claim 1 and microneedles provided in particular at each mounting element.

    14. A microneedle array device, comprising a plate-shaped base element, mounting elements provided on a front side of the base element, each for connecting to one micro-needle of the micro-needle array, microneedles connected with the mounting elements, and a packaging element packaging at least the microneedles, in particular in a sterile manner.

    15. The microneedle array device according to claim 14, wherein a connecting surface, in particular an adhesive surface for a packaging element, in particular a packaging film, is provided in an edge region on the front side and/or the rear side of the base element.

    16. The microneedle array device according to claim 14, wherein the packaging element comprises a recess for receiving the carrier element, the recess being closed at least on one side with a packaging film, in particular a peelable packaging film.

    17. The microneedle array device according to claim 16, wherein the packaging film is provided at least on the side of the microneedles.

    18. The microneedle array device according to claim 16, wherein a holder for holding the carrier element by an applicator is provided on a rear side of the base element.

    19. The microneedle array device according to claim 14, wherein a holder for holding the carrier element by an applicator is provided on a rear side of the base element.

    20. The microneedle array device according to claim 14, wherein a carrier element is further provided, the carrier element comprising: a plate-shaped base element, mounting elements provided on a front side of the base element, each for connecting to one micro-needle of the micro-needle array, and connecting elements provided in particular on the front sides of the mounting elements, wherein the connecting elements have an undercut in the longitudinal direction.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0034] In the following, the disclosure is described in more detail by means of a preferred embodiment with reference to the accompanying drawings.

    [0035] In the drawings:

    [0036] FIG. 1 is a schematic perspective view of a first embodiment of a carrier element from below,

    [0037] FIG. 2 is a schematic sectional view of the carrier element of FIG. 1 along line II-II,

    [0038] FIG. 3 is a schematic sectional view of a die,

    [0039] FIG. 4 is a schematic sectional view of the carrier element of FIGS. 1 and 2 in combination with the die of FIG. 3,

    [0040] FIG. 5 is a schematic perspective view of a second embodiment of a carrier element from below,

    [0041] FIG. 6 is a schematic sectional view of the carrier element of FIG. 5 along line VI-VI,

    [0042] FIG. 7 is a schematic sectional view of the carrier element of FIGS. 5 and 6 in combination with the die of FIG. 3,

    [0043] FIG. 8 is a schematic sectional view of the carrier element of FIGS. 5 and 6 according to an alternative embodiment,

    [0044] FIG. 9 is a schematic side view of a further embodiment of the carrier element,

    [0045] FIG. 10 shows a first preferred embodiment of a microneedle array device based on the carrier element of FIG. 9,

    [0046] FIG. 11 shows a second preferred embodiment of a microneedle array device based on the carrier element of FIG. 9, and

    [0047] FIG. 12 shows a third preferred embodiment of a microneedle array device based on the carrier element of FIG. 9.

    DESCRIPTION OF THE INVENTION

    [0048] A first embodiment of a carrier element (FIG. 1 and FIG. 2) comprises a plate-shaped base element 10. A plurality of frustoconical mounting elements 14 is arranged on a front side 12 of the base element 10. In the embodiment illustrated, only 9 such mounting elements are illustrated for the sake of clarity.

    [0049] In the embodiment illustrated, each of the mounting elements 14 comprises a connecting element 16. In the first embodiment, the connecting element 16 designed as a channel that extends from a front side 18 of the mounting elements to a rear side 20 of the base elements. In a first section 24 of the channel 16 that extends in the longitudinal direction 22, the channel has a smaller diameter than in a second section 26. Due to the different cross sections in the sections 24 and 26 of the channel 16, an undercut is formed.

    [0050] A die 28 (FIG. 3) is used to manufacture the microneedle array. The die 28 has a plurality of conical indentations 30. The arrangement and the number of the conical indentations 30 corresponds to the arrangement and the number of the mounting elements 14.

    [0051] First, the indentations 30 are filled in part with a liquid 32. Here, the liquid 32, which contains an active ingredient, is dosed such that the indentations 30 are filled only in part.

    [0052] In the next step, the carrier material is placed on an upper surface 34 of the die 32 such that the front side 12 of the base element 10 rests on the upper surface 34 (see FIG. 4). Here, the mounting elements 14 are arranged in the indentations 30, with the liquid 32 penetrating into the channel 16, in particular into the first channel section 24. A part of the liquid also penetrates into the channel section 26 so that an undercut is made (as can be seen in FIG. 4). When demolding the carrier element in the longitudinal direction or the demolding direction 22, it is thus ensured that the parts 22 of the liquid forming the microneedles remain fixedly connected with the mounting elements 14 due to the undercut.

    [0053] In the second embodiment described with reference to FIGS. 5 to 7, similar and identical components are identified by the same reference numerals.

    [0054] In the second preferred embodiment, connecting elements 36 are provided as connecting elements on the front sides 18 of the mounting elements 14. The connecting elements 36 are designed as protrusions that are mushroom-shaped in cross section. Thus, the protrusions 36 have an in particular annular groove 38 in the longitudinal or demolding direction 22. The groove 38 forms an undercut with respect to a headshaped element 40 of the protrusions 36.

    [0055] The manufacture of a carrier element with microneedles is carried out correspondingly as described above with reference to the first embodiment and FIGS. 3 and 4. As can be seen in FIG. 7, the liquid 32 encloses the protrusions 36, so that, due to the undercut, firm, in particular positive connection between the mounting elements 14 and the liquid 32 forming the needle is realized.

    [0056] FIG. 8 illustrates an alternative embodiment to the embodiment illustrated in FIGS. 5 to 7. The connecting elements are designed identically. The only difference is that the mounting elements 14 comprise a longer shaft 42, so that the front side 12 of the base element 10 is spaced from the upper surface 34 of the die 28. Thereby, needles of different lengths can be manufactured in a simple manner, while using the same die 28.

    [0057] FIG. 9 illustrates a development of the second embodiment illustrated in FIGS. 5 to 7. Here, a holder 34 is provided on the rear side 20 of the base element 10. In the embodiment illustrated, the holder 44 is formed to be circular cylindrical and has an annular groove 46. It is possible to connect the carrier element with an applicator via the holder 44. For example, a reliable fixation can be made by a latching connection that latches into the groove 46.

    [0058] The holder 44 could of course also be arranged on the rear side of the first embodiment illustrated in FIGS. 1 to 4.

    [0059] FIGS. 10 to 12 show different embodiments of a microneedle array device based on the carrier element with the holder 44 illustrated in FIG. 9.

    [0060] For sterile packaging, the embodiment illustrated in FIG. 10 is provided with a connecting surface 50 in an edge region 48 on the front side 12 of the base element 10. In particular, the connecting surface 50 is an adhesive surface. The connecting surface 50 is provided circumferentially on the front side 12 of the base element 10 and thus encloses the mounting elements 14 in a frame-shaped manner. Using a packaging film 52 provided on the adhesive surface 50, it is readily possible to package the microneedle array, i.e. in particular the region that comes into contact with the patient, in a sterile manner.

    [0061] An alternative packaging option is illustrated in FIG. 11. In this embodiment, the corresponding packaging element 54, which is again implemented in particular as a film, extends around the edge region of the base element 10. On the rear side 20, the connecting layer 50 is again provided in the edge region 48. This connecting layer is also formed in particular frame-shaped and encloses the entire base element 10.

    [0062] In the embodiment illustrated in FIG. 12, the carrier element is arranged in an additional package 46 together with the needles 32 formed by the liquid. The additional package 56 has a recess or opening 58 in which in particular the base element 10 of the carrier element is arranged. In the embodiment illustrated, the recess is closed on the side of the microneedles 32 by a packaging film 60 which is fastened on the outer side of the additional package by adhesive surfaces 50. Opposite thereto, another packaging film 62 is provided which has an adhesive surface 50 on an outer side of the additional package 56.

    [0063] The additional package illustrated in FIG. 12 provides protection for the entire carrier element including the holder 40 arranged on the rear side 20 of the base element 10. Here, the carrier element itself can be retained in the opening 58 of the additional package 56 by locking hooks, mounting elements or the like. Thereby, it is possible to readily retain the carrier element in a defined position until, for example, a force is applied by an applicator via the holder 44.

    [0064] In the embodiment illustrated, a groove with a semicircular cross section may be provided in the outer side of the package 56. Thereby, it is possible to mount the entire additional package 56 in an applicator or receive it in an applicator. Then, all that is required for application is to remove the packaging film 60.