MICRONEEDLE ARRAYS AND METHODS FOR FABRICATING MICRONEEDLE ARRAYS

• US 20190091455A1
• Filed: 09/28/2017
• Published: 03/28/2019
• Est. Priority Date: 09/28/2017
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Reitz, James A., Russell, Raymond M., Cannistraci, Anthony C., Pavell, David
• Granted Patent: US 10,525,244 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B21D 17/02 by pressing grooving or notching of bolts, studs, or the like B21K1/54
• CPC Class Codes: B21D 22/02 Stamping using rigid devices or tools
• CPC Class Codes: B21D 22/04 for dimpling combined with perforating B21D28/24

Abstract

Microneedle arrays, methods for fabricating microneedle arrays, medical devices, and methods for operating medical devices are provided. A method for fabricating a microneedle array includes providing a sheet blank of material. Further, the method includes stamping the sheet blank of material with a progression of dies, wherein the material is displaced into the microneedle array. A medical device includes a microneedle array, a base member having a first surface supporting the microneedle array and a second surface, and a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member. The flexible wall is biased toward an extended configuration enclosing a first volume in the chamber. Further, the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

Claims

1. A method for fabricating a microneedle array, the method comprising:

providing a sheet blank of material; and

stamping the sheet blank of material with a progression of dies to displace the material into a plurality of microneedles forming the microneedle array.

2. The method of claim 1 further comprising drilling a hole into a selected microneedle in the microneedle array.

3. The method of claim 1 further comprising drilling a hole into a selected microneedle in the microneedle array via electrical discharge machining (EDM).

4. The method of claim 1 further comprising cutting the sheet blank of material into a carrier strip and a microneedle array region connected to the carrier strip, wherein stamping the sheet blank of material with the progression of dies comprises stamping the microneedle array region with the progression of dies.

5. The method of claim 4 further comprising separating the microneedle array region from the carrier strip after stamping the microneedle array region to displace the material into the microneedle array.

6. The method of claim 4 further comprising piercing the microneedle array region to form a center hole therethrough.

7. The method of claim 4 further comprising piercing the microneedle array region to form a center hole and radially-spaced holes therethrough.

8. The method of claim 4 further comprising perforating the sheet blank of material.

9. The method of claim 1 wherein the microneedle array is arranged in a circle.

10. A method for fabricating a deep drawn microneedle array, the method comprising the steps of:

providing a sheet blank of material; and

reverse drawing the sheet blank of material to form the microneedle array comprising microneedles extending up from a base member, wherein the height of the microneedles above the base member is greater than the thickness of the base member.

11. The method of claim 10 further comprising drilling a hole into a selected microneedle in the microneedle array.

12. The method of claim 10 further comprising drilling a hole into a selected microneedle in the microneedle array via electrical discharge machining (EDM).

13. The method of claim 10 further comprising cutting the sheet blank of material into a carrier strip and a microneedle array region connected to the carrier strip, wherein reverse drawing the sheet blank of material to form the microneedle array comprises reverse drawing the microneedle array region to form the microneedle array.

14. The method of claim 13 further comprising separating the microneedle array region from the carrier strip after reverse drawing the sheet blank of material to form the microneedle array.

15. The method of claim 13 further comprising piercing the microneedle array region to form a center hole and radially-spaced holes therethrough.

16. The method of claim 13 further comprising perforating the microneedle array region.

17. The method of claim 10 wherein the material is stainless steel or titanium.

18. A microneedle array comprising:

a one-piece planar base member having an upper surface and a thickness; and

needles formed from and unitary with the base member, wherein the needles terminate at a height above the upper surface, and wherein the height is greater than the thickness.

19. The microneedle array of claim 18 wherein the base member is formed with an outer radial edge and an inner radial edge, wherein the inner radial edge bounds a center hole through the base member.

20. The microneedle array of claim 18 wherein the base member is perforated.