Medical devices with microneedle arrays and methods for operating such medical devices

• US 10,524,730 B2
• Filed: 09/28/2017
• Issued: 01/07/2020
• 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
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/719,359
• Publication Number:
  US 20190090811A1
• Time in Patent Office: 831 Days
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B21D 22/28 of cylindrical articles using consecutive dies

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 medical device comprising:

a microneedle array;

a base member having a first surface supporting the microneedle array and a second surface, wherein the base member includes inter-needle regions wherein the first surface is not covered with a microneedle from the microneedle array, and wherein the base member is perforated with holes extending from the first surface through the second surface in the inter-needle regions; and

a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member, wherein the flexible wall is biased toward an extended configuration enclosing a first volume in the chamber, wherein the flexible wall is movable to a depressed configuration enclosing a second volume in the chamber less than the first volume.

2. The medical device of claim 1 further comprising a sensor component between the base member and the flexible wall.

3. The medical device of claim 2 wherein the sensor component covers the second surface of the base member and is porous.

4. The medical device of claim 1 wherein microneedles in the microneedle array are solid and do not include holes therethrough.

5. The medical device of claim 1 wherein the microneedle array and the first surface of the base member form a front side of the medical device, wherein the medical device further comprises solid, liquid, or gel media on the front side of the medical device, and wherein the media is selected from insulin, medications, vitamins, hormones, nutritional media, tracing media, or hydration media.

6. The medical device of claim 1 wherein the flexible wall is a spherical dome.

7. The medical device of claim 1 wherein the microneedle array surrounds an opening, and wherein the medical device further comprises a sensor component located in the opening and supported by the first surface of the base member.

8. The medical device of claim 1 further comprising a sensor component supported by the first surface of the base member and at least partially surrounding the microneedle array.

9. The medical device of claim 1 wherein a selected microneedle in the microneedle array is formed with a hole extending from an exterior surface of the selected microneedle to an interior surface of the selected microneedle.

10. A medical device comprising:

a microneedle array configured to pierce a treatment area;

a base member having a first surface supporting the microneedle array and a second surface;

a sensor component on the first surface of the base member; and

a chamber connected to the second surface of the base member, wherein the chamber is bound by a flexible wall and configured to apply a suction force to the treatment area.

11. The medical device of claim 10 wherein the microneedle array surrounds an opening, and wherein the sensor component is located in the opening.

12. The medical device of claim 10 wherein the microneedle array has a periphery, wherein the first surface of the base member includes a peripheral region extending from the periphery of the microneedle array to an outer edge, and wherein the sensor component is located on the peripheral region of the base member and surrounds the microneedle array.

13. A method for operating a medical device, the method comprising:

providing the medical device comprising;

a microneedle array;

a base member having a first surface supporting the microneedle array and a second surface;

a flexible wall enclosing a chamber between the flexible wall and the second surface of the base member, wherein the flexible wall is biased toward an extended configuration enclosing a first volume in the chamber; and

a fluid contained in the chamber, wherein the fluid is selected from insulin, medications, vitamins, hormones, nutritional media, tracing media, or hydration media;

piercing a treatment area with the microneedle array; and

applying a force to depress the flexible wall to a depressed configuration enclosing a second volume in the chamber less than the first volume and expelling the fluid onto and/or into the treatment area.

14. The method of claim 13 wherein the base member includes inter-needle regions wherein the first surface is not covered with a microneedle from the microneedle array, wherein the base member is perforated with holes extending from the first surface through the second surface in the inter-needle regions;

and wherein expelling the fluid onto and/or into the treatment area comprises expelling the fluid through the holes in the inter-needle regions.

15. The method of claim 13 wherein a selected microneedle in the microneedle array is formed with a hole extending from an exterior surface of the selected microneedle to an interior surface of the selected microneedle, and wherein applying the force to depress the flexible wall to the depressed configuration comprises expelling the fluid from the chamber and through the hole in the selected microneedle.

16. The method of claim 13 wherein the flexible wall expands to the extended configuration after the force is removed from the flexible wall causing a body fluid to be drawn from the treatment area and to the medical device.

17. The method of claim 16 wherein the medical device further comprises a sensor component between the base member and the flexible wall, and wherein when the flexible wall expands to the extended configuration after the force is removed from the flexible wall the body fluid is drawn from the treatment area and into contact with the sensor component.

18. The method of claim 13 wherein the microneedle array has a periphery, wherein the first surface of the base member includes a peripheral region extending from the periphery of the microneedle array to an outer edge, and wherein the medical device further comprises a sensor component located on the peripheral region of the base member and surrounding the microneedle array.

19. The method of claim 13 wherein the microneedle array surrounds an opening, wherein the medical device further comprises a sensor component located in the opening and supported by the first surface of the base member, and wherein the medical device further comprises a sensor component supported by the first surface of the base member and at least partially surrounding the microneedle array.

20. The method of claim 13 wherein the medical device further comprises a sensor component supported by the first surface of the base member and at least partially surrounding the microneedle array, and wherein when the flexible wall expands to the extended configuration after the force is removed from the flexible wall a fluid is drawn from the treatment area and into contact with the sensor component.