Hollow microneedle array article

• US 10,099,043 B2
• Filed: 07/10/2014
• Issued: 10/16/2018
• Est. Priority Date: 07/16/2013
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Berry, Dennis G., Martinson, Paul A., Simmers, Ryan Patrick
• Primary Examiner(s): Dougherty, Sean
• Application Number:
  US14/905,018
• Publication Number:
  US 20160151617A1
• Time in Patent Office: 1,559 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

An article 100 having a first side 112 that has a central portion 130 defined by a first edge 134, a microneedle-free peripheral portion 140 that substantially surrounds the central portion, and a plurality of spaced-apart hollow microneedles 160. Each microneedle has a body that includes an outer surface 163; a base segment 166 having a base 162 and a first shape; a tip segment 168 having a tip 164 and a second shape, wherein the second shape is distinct from the first shape; a transition plane 167 that delineates the base segment and the tip segment; and a central axis 180. An angle, defined by an intersection of the central axis of at least one microneedle and a shortest line extending from the first edge and through the transition plane of the at least one microneedle, is less than about 50°.

Claims

1. An article, comprising:

a first side comprising;

a central portion defined by a first edge;

a microneedle-free peripheral portion that substantially surrounds the central portion; and

a plurality of spaced-apart hollow microneedles extending from the central portion in a first direction;

wherein each microneedle of the plurality comprises a body that includes;

an outer surface;

a base segment having a base and a first shape that is defined by the outer surface;

a tip segment having a tip and a second shape that is defined by the outer surface, wherein the second shape is distinct from the first shape;

a transition plane that delineates the base segment and the tip segment;

a hollow channel extending through the body of the microneedle from a first opening proximate the tip to a second opening proximate the base;

a central axis;

wherein the plurality of hollow microneedles forms an array that comprises three or more perimeter microneedles disposed proximate the first edge;

wherein the central portion is not coplanar with the peripheral portion;

wherein the peripheral portion is canted in a second direction relative to the central portion at an angle of 10°

to 80°

, wherein the second direction is opposite the first direction;

wherein an angle, defined by an intersection of the central axis of at least one of the plurality of microneedles and a shortest line extending from the first edge and through the transition plane of the at least one microneedle, is less than about 50°

.

2. The article of claim 1, wherein the first angle is less than about 45°

.

3. The article of claim 1, wherein each microneedle of the plurality comprises a microneedle height measured from the base to the tip, wherein the microneedle height of each microneedle of the plurality is about 600 microns to about 2000 microns.

4. The article of claim 3, wherein each microneedle of the plurality comprises a first height component measured along the central axis from the base to the transition plane, wherein the first height component is about 500 m to about 800 m.

5. The article of claim 1, wherein the perimeter microneedles define a two-dimensional first geometric shape, wherein the first geometric shape defines a first area, wherein the plurality of microneedles further comprises one or more interior microneedles that is substantially uniformly distributed within the first area.

6. The article of claim 1, wherein the central portion comprises a microneedle tip-free second area within the first area, wherein the second area is at least about 15% of the first area.

7. The article of claim 6, wherein the second area is up to about 99%, inclusive, of the first area.

8. The article of claim 1, wherein the first geometric shape defines a substantially regular polygon.

9. The article of claim 1, wherein the first edge defines a second geometric that is larger than, but substantially identical to, the first geometric shape.

10. The article of claim 9, wherein the first edge comprises a plurality of corners, wherein at least one of the corners is curvate.

11. The article of claim 1, wherein the peripheral portion is canted about 18 degrees to about 80 degrees, inclusive, in relationship to the central portion.

12. The article of claim 1, wherein each of the perimeter microneedles has a shortest distance from its central axis and the first edge, wherein the shortest distance of all of the perimeter microneedles is approximately equal.

13. The article of claim 1, wherein the central axis of each of the microneedles defines a longitudinal axis of the microneedle, wherein the outer surface of a base segment of each microneedle in the plurality of microneedles comprises a radius of curvature along the longitudinal axis.

14. The article of claim 1, wherein the article further comprises a side wall portion that extends from the peripheral portion, wherein the sidewall portion extends substantially in the second direction.

15. The article of claim 1, wherein the body of each microneedle of the plurality of microneedles comprises tip segment and a maximum diameter of the tip segment, wherein the tip segment of the at least one microneedle further comprises a bevel surface with a truncated bevel, wherein the truncated bevel is defined by a first plane extending diagonally from the tip toward the base through about 75% to about 95% of the body diameter and a second plane that intersects the first plane, wherein the second plane extends laterally from the outer surface through not more than 25% of the body diameter and is substantially perpendicular to the central axis, wherein the truncated bevel comprise a bevel opening that opens into a channel that extends into the body of the at least one microneedle.

16. The article of claim 1:

wherein the tip segment comprises a beveled surface and an opening in the beveled surface;

wherein at least one microneedle of the plurality of microneedles comprises a first channel that extends into the microneedle from the bevel opening along the central axis through at least a portion of the microneedle, and a second channel that extends radially from the first channel to the bevel opening;

wherein the first channel has a first wall that is substantially aligned with the central axis;

wherein the second channel has a wall that is oriented substantially orthogonal to the central axis;

wherein the first channel and second channel merge to form the bevel opening.

17. The article of claim 1, further comprising a reservoir that is in fluidic communication with the hollow channel.

18. A method of using the hollow microneedle article of claim 1, the method comprising injecting fluid from the hollow microneedle article into a body.

19. A method of extracting fluid from a body, the method comprising contacting the hollow microneedle article of claim 1 with fluid within a body and extracting the fluid from the body into one or more of the hollow microneedles of the hollow microneedle article.