Microneedle system for administering liquid formulations

Patent metadata

Field	Value
Publication number	US-11344708-B2
Application number	US-201615565025-A
Country	US
Kind code	B2
Filing date	Apr 7, 2016
Priority date	Apr 7, 2015
Publication date	May 31, 2022
Grant date	May 31, 2022

Abstract

The present invention relates to a microneedle system (MNS) for intradermally delivering solutions or formulations. The invention relates to a microneedle system, comprising a cover element ( 1 ), an active substance container ( 2 ), a frame ( 3 ), a microneedle array (MNA) ( 4 ) and a base plate ( 5 ), wherein the microneedle array (MNA) ( 4 ) is connected to the frame ( 3 ), and the base plate ( 5 ) has an opening for receiving the microneedle array ( 4 ), the cover element ( 1 ) and the base plate ( 5 ) are movably connected to one another, the base plate ( 5 ) is joined to a surgical tape ( 6 ), and the frame ( 3 ) and the base plate ( 5 ) can be linearly displaced with respect to one another.
The MNS according to the invention is suitable for intradermally administering medicinal drugs, active substances, pharmaceutical or cosmetic compositions or other substances to an individual, and preferably to a patient, over an extended period.

First claim

The invention claimed is:

1. A microneedle system for intradermal delivery, comprising: a base plate, the base plate being at least partially joined to a surgical tape, a frame directly above and movably connected to the base plate, a microneedle array in the frame for joint movement with the frame, an active substance container accommodated in the frame directly above the microneedle array and the base plate, the base plate having opening for receiving the microneedle array when the frame is linearly displaced in the direction of the opening in the base plate whereby the microneedle array may penetrate the skin of a patient, the base plate having at least one opening element for opening the active substance container to permit a substance to flow from the active substance container, the at least one opening element being separate and distinct from the microneedle array, the surgical tape having at least one passageway for permitting the substance from the active substance container to reach the skin of the patient, a cover element directly over the active substance container, the cover element being movably connected to the base plate by a thread on the cover element engaged with a complementary thread on the base plate, the microneedle system being activated from a cover element storage position of the cover element and an active substance container storage position of the active storage container to a cover element delivery position of the cover element and an active substance container delivery position of the active substance container by rotation of the cover element to move the cover element closer to the base plate and cause the at least one opening element to open the active substance container and to lower the microneedle array into contact with the skin, and the cover element being in contact with the frame to push the frame in the direction of the opening in the base plate when the microneedle system moves from the cover element storage position to the cover element delivery position and to also move the entire active substance container along with the frame from the active substance container storage position to the active substance container delivery position, and the cover element being more tightly in threaded engagement with the base plate in the cover element delivery position than in the cover element storage position, wherein the base plate has a peripheral projection extending upwardly around the periphery of the base plate opening, the base plate having an edge, the peripheral projection being inwardly offset with respect to the base plate edge, the at least one opening element being on an inner surface of the peripheral projection, and the base plate complementary thread being on an outer side of the edge.

2. The microneedle system according to claim 1 , wherein the frame comprises one or more catch hooks engaged in recesses in the base plate.

3. A microneedle system for intradermal delivery, comprising: a base plate, the base plate being at least partially joined to a surgical tape, a frame directly above and movably connected to the base plate, a microneedle array in the frame for joint movement with the frame, an active substance container accommodated in the frame directly above the microneedle array and the base plate, the base plate having opening for receiving the microneedle array when the frame is linearly displaced in the direction of the opening in the base plate whereby the microneedle array may penetrate the skin of a patient, the base plate having at least one opening element for opening the active substance container to permit a substance to flow from the active substance container, the at least one opening element being separate and distinct from the microneedle array, the surgical tape having at least one passageway for permitting the substance from the active substance container to reach the skin of the patient, a cover element directly over the active substance container, the cover element being movably connected to the base plate by a thread on the cover element engaged with a complementary thread on the base plate, the microneedle system being activated from a cover element storage position of the cover element and an active substance container storage position of the active storage container to a cover element delivery position of the cover element and an active substance container delivery position of the active substance container by rotation of the cover element to move the cover element closer to the base plate and cause the at least one opening element to open the active substance container and to lower the microneedle array into contact with the skin, and the cover element being in contact with the frame to push the frame in the direction of the opening in the base plate when the microneedle system moves from the cover element storage position to the cover element delivery position and to also move the entire active substance container along with the frame from the active substance container storage position to the active substance container delivery position, and the cover element being more tightly in threaded engagement with the base plate in the cover element delivery position than in the cover element storage position, wherein the frame comprises one or more catch hooks engaged in recesses in the base plate, wherein the one or more catch hooks prevent rotation of the frame within the base plate, and the cover element being in contact with the frame by being in contact with the one or more catch hooks.

4. The microneedle system according to claim 3 , wherein the thread on the cover element thread is located on a bottom side of the cover element and comprises a peripheral thread.

5. The microneedle system according to claim 3 , wherein the cover element comprises one or more markings, which define how the microneedle system can be transferred from the storage position into the delivery position.

6. The microneedle system according to claim 3 , wherein the surgical tape is protected by a protective film.

7. The microneedle system according to claim 3 , wherein the diameter of the microneedle system is at least 10 mm.

8. The microneedle system according to claim 3 , wherein the diameter of the microneedle system is at least 25 mm.

9. The microneedle system according to claim 3 , wherein the diameter of the microneedle system is at least 50 mm.

10. The microneedle system according to claim 3 , wherein the height of the microneedle system is no more than 30 mm.

11. The microneedle system according to claim 3 , wherein the height of the microneedle system is no more than 20 mm.

12. The microneedle system according to claim 3 , wherein the height of the microneedle system is no more than 10 mm.

13. The microneedle system according to claim 9 , wherein the height of the microneedle system is no more than 10 mm.

14. The microneedle system according to claim 3 , wherein the active substance container is a blow-fill-seal container or a disposable container.

15. The microneedle system according to claim 3 , wherein the active substance container contains one or more substances, medicinal drugs, active agents, solutions or liquid formulations.

16. The microneedle system according to claim 3 , comprising the active substance container, containing active substances in a liquid formulation for use in the intradermal delivery.

17. The microneedle system according to claim 3 , wherein the entire active substance container is spaced from and out of contact with the cover element.

18. The microneedle system according to claim 3 , wherein the at least

Assignees

• Lts Lohmann Therapie Systeme Ag

Inventors

• Heuser Karsten
• Spilgies Heiko

Classifications

• A61M37/0015 Primary

  by using microneedles · CPC title

• A61M2037/0023

  Drug applicators using microneedles · CPC title

• A61B17/205 Primary

  Vaccinating by means of needles or other puncturing devices · CPC title

• A61M2037/003

  having a lumen · CPC title

• A61M2037/0053

  Methods for producing microneedles · CPC title