MICRONEEDLE AND METHOD FOR PRODUCING A MICRONEEDLE

Abstract

Microneedle, in particular for transdermal and/or intradermal active ingredient delivery, having a support structure and having at least one needle structure arranged on the support structure for penetrating the horny cell layer of human and/or animal skin, characterized in that at least the needle structure is produced by 3D screen printing.

Claims

1. A microneedle (10) for transdermal and/or intradermal active ingredient delivery, having a support structure (12) and having at least one needle structure (14) arranged on the support structure (12) for penetrating the horny cell layer of human and/or animal skin, wherein at least the at least one needle structure (14) is produced by 3D screen printing.

2. The microneedle (10) according to claim 1, wherein: the support structure (12) is produced by 3D screen printing, and/or the needle structure (14) and the support structure (12) are formed integrally and/or are produced by an uninterrupted process sequence.

3. The microneedle (10) according to claim 1, wherein: the support structure (12) is generated separately from the needle structure (14), and/or the needle structure (14) is arranged and/or attached to the support structure (12) by means of 3D screen printing.

4. The microneedle (10) according to claim 1, wherein the needle structure (14) is at least sectionally cylindrical and/or has an at least sectionally constant and/or circular cross-section along its longitudinal extent.

5. The microneedle (10) according to claim 1, wherein the entire needle structure (14) is cylindrical in shape and/or has a constant and/or circular cross-section along its longitudinal extension.

6. The microneedle (10) according to claim 1, wherein the needle structure (14) has a varying cross-section along its longitudinal extension.

7. The microneedle (10) according to claim 1, wherein the needle structure (14) has different cross-sectional sizes and/or constant cross-sectional shapes along its longitudinal extension.

8. The microneedle (10) according to claim 1, wherein the needle structure (14) is stepped along its longitudinal extension.

9. The microneedle (10) according to claim 8, wherein the needle structure (14) has a constant cross-section between at least two steps (18).

10. The microneedle (10) according to claim 1, wherein the needle structure (14) has along its longitudinal extension, at least in sections, a cross-sectional diameter of at least 30 μm, and less than 300 μm.

11. (canceled)

12. The microneedle (10) according to claim 1, wherein the needle structure (14) has an overall length as defined between the support structure (12) and a free end (16) facing away from the support structure (12) of at least 200 μm.

13. (canceled)

14. The microneedle (10) according to claim 1, wherein the needle structure (14) comprises at least one needle structure portion (20) extending longitudinally between two steps (18) and having a length of at least 20 μm and less than 200 μm.

15. (canceled)

16. The microneedle (10) according to claim 1, wherein the needle structure (14) comprises at least one active ingredient.

17. (canceled)

18. The microneedle (10) according to claim 16, wherein the needle structure (14) has different active ingredient densities along its longitudinal extension or wherein the needle structure (14) has different active ingredients along its longitudinal extension.

19. (canceled)

20. (canceled)

21. The microneedle (10) according to claim 1, wherein the needle structure (14) comprises a coating (22) formed for dissolution, the coating having at least one active ingredient.

22. The microneedle (10) according to claim 1, wherein the needle structure (14) comprises a cavity (26) with at least one active ingredient disposed therein, and the needle structure (14) is configured for active ingredient delivery from the cavity (26) of the needle structure (14).

23. A microneedle (10) for transdermal and/or intradermal active ingredient delivery, having a support structure (12) and having at least one needle structure (14) arranged on the support structure (12) for penetrating the horny cell layer of human and/or animal skin, wherein the needle structure (14) has a constant cross section along its longitudinal extent.

24. A microneedle (10) for transdermal and/or intradermal active ingredient delivery, having a support structure (12) and having at least one needle structure (14) arranged on the support structure (12) for penetrating the horny cell layer of human and/or animal skin, wherein the needle structure (14) is stepped along its longitudinal extent.

25. A microneedle (10) for transdermal and/or intradermal active ingredient delivery, having a support structure (12) and having at least one needle structure (14) arranged on the support structure (12) for penetrating the horny cell layer of human and/or animal skin, wherein the needle structure (14) comprises at least one active ingredient, and has different active ingredient densities along its longitudinal extent and/or different active ingredients along its longitudinal extent.

26. A microneedle device (30) for transdermal and/or intradermal active ingredient delivery, comprising a plurality of microneedles, the microneedles each being the microneedles (10) according to claim 1, wherein the microneedles (10) form a needle array (34).

27. The microneedle device (30) according to claim 26, wherein the supporting sections (12) of each of the microneedles (14) are integrally formed with each other or connected to form an overall support structure (32).

28. (canceled)

29. A method for producing the microneedle (10) of claim 1, comprising providing the support structure (12) and producing the at least one needle structure (14) by 3D screen printing such that it is arranged on the support structure (12).

30. The microneedle device of claim 27, wherein the device is in the form of a medical patch.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The present invention is explained in more detail below by way of example with reference to the accompanying figures.

[0051] It is shown schematically in each case:

[0052] FIG. 1 a perspective view of a microneedle according to a first embodiment of the present invention,

[0053] FIG. 2 a perspective view of a microneedle according to a further embodiment of the present invention,

[0054] FIG. 3A a perspective view of a microneedle according to a still further embodiment of the present invention,

[0055] FIG. 3B a longitudinal section of the microneedle according to FIG. 3A,

[0056] FIG. 4A a perspective view of a microneedle according to a still further embodiment of the present invention,

[0057] FIG. 4B a longitudinal section of microneedle shown in FIG. 4A,

[0058] FIG. 5 a perspective view of a microneedle device according to an embodiment of the present invention, and

[0059] FIG. 6 a perspective view of a medical patch according to one embodiment of the present invention.

DETAILED DESCRIPTION

[0060] FIG. 1 shows a microneedle 10 according to an embodiment of the present invention. The microneedle 10 has a support structure 12 and at least one needle structure 14 arranged on the support structure 12 for penetrating the horny cell layer of human and/or animal skin. In particular, the needle structure 14 may be dimensioned for penetrating the horny cell layer of human and/or animal skin or may have a geometric shape suitable therefor.

[0061] According to the invention, the needle structure 14 can be produced by additive manufacturing, in particular 3D screen printing. For this purpose, the needle structure 14 can be built up in layers, for example. Between individual steps for layer-by-layer production, drying steps can take place which ensure drying of the respective preceding printed layer.

[0062] It is also possible that the support structure 12 is produced by additive manufacturing, in particular 3D screen printing. The needle structure 14 and the support structure 12 may further be integrally formed and/or produced by an uninterrupted sequence of processes. In particular, it is possible that both the support structure 12 and the needle structure 14 are produced by means of 3D screen printing and an uninterrupted process sequence of layer-by-layer construction is used for this purpose.

[0063] Furthermore, it is possible that the support structure 12 is generated separately from the needle structure 14 and that the needle structure 14 is arranged and/or attached to the support structure 12 by means of additive manufacturing, in particular 3D screen printing.

[0064] As can be seen from FIG. 1, the needle structure 14 can be cylindrical at least in sections or have a cross-section that is constant and/or circular at least in sections along its longitudinal extent. In particular, the entire needle structure 14 can be cylindrical or have a uniform and/or circular cross section along its longitudinal extent.

[0065] The needle structure 14 may have along its longitudinal extension, at least in sections, a cross-sectional diameter of at least 30 μm, preferably of at least 50 μm, preferably of at least 70 μm, more preferably of at least 80 μm or of more than 90 μm. It is likewise possible for the needle structure 14 to have along its longitudinal extent, at least in sections, a cross-sectional diameter of more than 100 μm, even more preferably of more than 150 μm, even more preferably of more than 200 μm, even more preferably of more than 250 μm, even more preferably of more than 300 μm.

[0066] Furthermore, along its longitudinal extension, the needle structure 14 may have, at least in sections, a cross-sectional diameter of less than 300 μm, preferably of less than 250 μm, preferably of less than 200 μm, more preferably of less than 150 μm or of less than 100 μm or of less than 90 μm or of less than 80 μm.

[0067] The needle structure 14 may further have an overall length of at least 200 μm, at least 300 μm, at least 400 μm, at least 500 μm, at least 600 μm, at least 700 μm, or less than 1000 μm, less than 900 μm, less than 800 μm, less than 700 μm, less than 600 μm, less than 500 μm, or less than 400 μm. In particular, the length of the needle structure 14 may extend between the support structure 12 and a free end 16 facing away from the support structure 12.

[0068] In the embodiment example according to FIG. 1, the needle structure 14 can have a cross-sectional shape and cross-sectional size that remains constant along the longitudinal extension. The outer circumference 15 of the needle structure 14 thus remains invariable along the longitudinal extension. Such a geometric design can be produced by means of additive manufacturing, in particular by means of 3D screen printing, with only little effort.

[0069] FIG. 2 shows a further embodiment of a microneedle 10 according to the present invention. The microneedle 10 according to FIG. 2 differs from the embodiment in FIG. 1 with respect to the geometric design of the needle structure 14. Thus, the needle structure 14 in FIG. 2 has a varying cross-section along its longitudinal extension. In particular, the needle structure 14 in FIG. 2 has varying cross-sectional sizes along its longitudinal extent. For this purpose, the needle structure 14 can be designed in a stepped manner along its longitudinal extension, for example.

[0070] In the embodiment example according to FIG. 2, four steps 18a, 18b, 18c and 18d are provided only as an example. Between steps 18a and 18b, 18b and 18c, and 18c and 18d, the needle structure 14 can have a constant cross-section or a cross-sectional shape that is continuous along its longitudinal extent. Likewise, the cross-sectional size may be of a constant design between two steps 18a and 18b or 18b and 18c or 18c and 18d. Finally, the cross-sectional size and/or cross-sectional shape may be designed to be constant between the support structure 12 and the step 18a and/or between the step 18d and the free end 16.

[0071] The steps 18a, 18b, 18c, and 18d may divide the needle structure 14 into a total of five needle structure sections 20a, 20b, 20c, 20d, and 20e. Here, the needle structure section 20a is adjacent to the support structure 12 and the needle structure section 20e forms the free end 16. The needle structure sections 20a to 20e may each have the same cross-sectional shape, but different cross-sectional sizes. As the distance from the support structure 12 increases, the respective cross-sectional diameters of the individual needle structure sections 20a to 20e may decrease. Accordingly, the cross-sectional size of the needle structure sections 20a to 20e may gradually decrease starting from the support structure 12.

[0072] The dimensions mentioned above with respect to the embodiment in FIG. 1 may also apply to the individual needle structure sections 20a to 20e. Furthermore, the specifications regarding the total length of the needle structure 14 in FIG. 2 may refer to the sum of the individual lengths of the needle structure sections 20a to 20e.

[0073] The length of a needle structure section 20b, 20c, and 20d extending between two steps 18a and 18b, 18b and 18c, and 18c and 18d may have a length of less than 200 μm, less than 150 μm, less than 100 μm, or less than 50 μm. Such a needle structure section may further have a length of at least 20 μm, at least 50 μm, at least 100 μm, at least 150 μm, at least 200 μm, or at least 250 μm. The foregoing dimensional specifications may further extend to the needle structure section 20a extending between the support structure 12 and the step 18a. Likewise, the foregoing dimensional specifications may apply to the needle structure portion 20e extending between the step 18d and the free end 16.

[0074] The needle structure 14 according to FIGS. 1 and 2 may have at least one active ingredient. Likewise, the needle structure 14 can have different active ingredients. The active ingredients or active ingredient densities of the needle structure 14 can be different along the longitudinal extension or vary along the longitudinal extension.

[0075] Furthermore, the needle structure 14 according to FIGS. 1 and 2 may be designed for active ingredient delivery by material dissolution. In particular, it is possible for the needle structure 14 to completely dissolve for active ingredient delivery. Removal of the needle structure 14 following active ingredient administration is thus dispensable.

[0076] FIGS. 3A and 3B show another embodiment of a microneedle 10 according to the present invention. The embodiment of FIG. 3 differs from the embodiment in FIG. 1 in that the needle structure 14 has a coating formed for dissolution with at least one active ingredient. The coating 22 may be formed on or arranged around a core structure 24. It is also possible that the core structure 24 is not designed for dissolution or is formed from a dissolution-resistant material that differs from the material of the coating 22.

[0077] Further, it is possible for both the coating 22 and the core structure 24 to be configured for active ingredient delivery by dissolution, with the coating 22 containing a different active ingredient or active ingredients than the core structure 24, so that a respective desired active ingredient delivery profile can be achieved. In the embodiment shown in FIG. 3, the foregoing dimensional specifications with respect to cross-sectional diameter may refer to the overall cross-sectional diameter formed by the core structure 24 as well as the coating 22.

[0078] FIGS. 4A and 4B show another embodiment of a microneedle 10 according to the present invention. The embodiment in FIGS. 4A and 4B differs from the embodiment in FIG. 1 in that the needle structure 14 has a cavity 26 with at least one active ingredient disposed therein. Accordingly, the needle structure 12 of FIGS. 4A and 4B may be configured for active ingredient delivery from the cavity 26 of the needle structure 14.

[0079] The cavity 26 may be a channel extending along the longitudinal extent, which ends into the free end 16 of the needle structure 14. The cavity 26 may further extend into an active ingredient reservoir 28, which is at least partially formed by the support structure 12 or is recessed in the support structure 12. It is further possible that the active ingredient reservoir 28 is formed only within the needle structure 14, which is not shown in more detail here.

[0080] After penetration of the horny cell layer of human and/or animal skin, an active ingredient delivery from the cavity 26 into the respective organism can be conducted, whereby emptying or partial emptying of the active ingredient reservoir 28 can also be realized. Moreover, the needle structure 14 may be designed to be resistant to dissolution in a living organism. Likewise, it is possible that the needle structure 14 according to FIG. 4 is also designed for active ingredient delivery by dissolution. In this case, the dissolution of the needle structure 14 can take place subsequent to the active ingredient delivery from the cavity 26, so that, for example, different active ingredients can be released into the respective organism in temporal succession.

[0081] FIG. 5 shows a microneedle device 30 according to one embodiment of the present invention. The microneedle device 30 comprises a plurality of microneedles 10 according to FIG. 1. Likewise, it is possible that the microneedle device 30 is formed from microneedles 10 according to any of the further embodiments shown in FIGS. 2 to 4, which is not shown in detail here.

[0082] According to FIG. 5, the individual microneedles 10 are provided within the microneedle device 30 in a specific arrangement relative to one another or form a predefined or also random arrangement pattern. In this case, the support structures 12 of the microneedles 10 can be connected to each other or formed integrally. The support structures 12 of the microneedles 10 can thus form an overall support structure 32 to which the individual needle structures 12 are arranged or attached.

[0083] The needle structures 12 of the individual microneedles 10 can have a defined distance from one another. Purely by way of example, the needle structures 12 of two directly adjacent microneedles 10 may have a spacing of more than 300 μm or less than 500 μm, purely by way of example about 350 μm. The number of individual microneedles 10 of a microneedle device 30 can be varied or selected as desired depending on the particular application. The microneedles 10 of the microneedle device 30 thus form a needle array 34.

[0084] FIG. 6 shows a medical plaster 36. Such a medical plaster 36 may comprise a microneedle device 30 or a plurality of microneedles 10. The microneedle device 30 or the microneedles 10 may be arranged or attached to an adhesive tape 38 or medical tape material. The adhesive tape 38 is particularly suitable for adhesive attachment to human or animal skin, whereby active ingredient delivery by the microneedles 10 over a period of time can be ensured with a high degree of safety.

LIST OF REFERENCE SIGNS

[0085] 10 Microneedle [0086] 12 Support structure [0087] 14 Needle structure [0088] 15 Outer circumference [0089] 16 free end [0090] 18a-18d Steps [0091] 20a-20e Needle structure sections [0092] 22 Coating [0093] 24 Core structure [0094] 26 Cavity [0095] 28 Active ingredient reservoir [0096] 30 Microneedle device [0097] 32 Overall support structure [0098] 34 Needle array [0099] 36 Medical plaster [0100] 38 Adhesive tape