Hollow microneedle with beveled tip

• US 10,232,157 B2
• Filed: 07/10/2014
• Issued: 03/19/2019
• 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): Price, Nathan R
• Assistant Examiner(s): Fredrickson, Courtney B
• Application Number:
  US14/904,975
• Publication Number:
  US 20160136406A1
• Time in Patent Office: 1,713 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 2037/0053 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: B28B 1/24 by injection moulding injection moulding of ceramic slips B28B1/265; of tubular articles B28B21/38
• CPC Class Codes: B29C 2045/0094 injection moulding of small-sized articles, e.g. microarticles, ultra thin articles
• CPC Class Codes: B29C 2059/023 Microembossing
• CPC Class Codes: B29C 45/2626 provided with a multiplicity of narrow cavities connected to a common cavity, e.g. for brushes, combs
• CPC Class Codes: B29C 45/2628 with mould parts forming holes in or through the moulded article, e.g. for bearing cages
• CPC Class Codes: B29C 59/025 Fibrous surfaces with piles or similar fibres substantially perpendicular to the surface
• CPC Class Codes: B29C 67/247 Moulding polymers or prepolymers containing ingredients in a frangible packaging, e.g. microcapsules expandable components kept in frangible containers within a flexible bag B29C44/183
• CPC Class Codes: B29K 2069/00 Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles

Abstract

An article having at least one microneedle (160, 260) is provided. The microneedle includes a base (162), an elongated body (161) having a central axis (130) and a body diameter (168), a tip portion (166), and a hollow channel (170). The a tip portion includes a tip (164), a first bevel face (140) oriented diagonally with respect to the central axis and extending through at least 75% of the body diameter, a second bevel face (146) oriented substantially perpendicular to the central axis and intersecting the first bevel face, and a bevel opening defined by a first edge (174) of the first bevel face and a second edge (176) of the second bevel face. The hollow channel extends axially into the body from the bevel opening (172).

Claims

1. An article, comprising:

at least one microneedle, the at least one microneedle comprising;

a base;

an elongated body having a central axis and a body diameter;

a tip portion comprising a tip, a first bevel face oriented diagonally with respect to the central axis and extending through about 75% to about 95% of the body diameter, a second bevel face oriented substantially perpendicular to the central axis and intersecting the first bevel face, a bevel opening defined by a first edge of the first bevel face and a second edge of the second bevel face; and

a hollow channel that extends axially into the body from the bevel opening;

wherein the second bevel face extends through no more than about 25% of the body diameter; and

wherein the first bevel face intersects the elongated body at the tip to form a sharp edge at the tip.

2. The article of claim 1, wherein the at least one microneedle comprises a wall having a width at the second bevel face, wherein the second bevel face has a length, wherein the length of the second bevel face is equal to the width of the wall at the second bevel face.

3. The article of claim 1, wherein the first bevel face defines a plane.

4. The article of claim 1, wherein the first bevel face comprises a plurality of intersecting planes.

5. The article of claim 4, wherein two or more of the planes intersect at a third edge, wherein the third edge extends along the first bevel face to the tip.

6. The article of claim 1, wherein the first bevel face defines a partial ellipse that substantially surrounds the bevel opening.

7. The article of claim 1, wherein a first two-dimensional area defined by the bevel opening is larger than a second two-dimensional area defined by a theoretical opening created by extending the first bevel face from the tip through 100% of the body diameter.

8. The article of claim 1, wherein the article further comprises a substrate having a first side and a second side, wherein the at least one microneedle extends from the first side of the substrate, wherein the channel extends from the opening through the elongated body to a second opening on the second side of the substrate.

9. The article of claim 1, wherein the at least one microneedle comprises a plurality of microneedles.

10. The article of claim 1, wherein the second bevel face is located closer to the base of the microneedle than the first bevel face.

11. A method of use of injecting fluid into a body, the method comprising providing an article of claim 1 that further comprises fluid, contacting the article with a body, and injecting the fluid into the body.

12. A method of extracting fluid from a body, the method comprising contacting an article of claim 1 with the body to puncture a surface of the body and removing fluid from the body through the hollow channel.

13. A method of making an article of claim 1, comprising at least one hollow microneedle that comprises a body having a central axis, a body diameter, a base, a tip portion, and a hollow channel;

the method comprising;

providing a first mold half comprising at least one cavity;

wherein the at least one cavity includes a cavity opening and a cavity surface having a first projection extending therefrom toward the cavity opening;

wherein the first projection defines a first segment of the hollow channel, the first segment extending into the body of the microneedle from the base;

wherein the first projection comprises a first longitudinal axis;

providing a second mold half comprising at least one second projection extending therefrom;

wherein the at least one second projection defines a tip portion of the at least one microneedle and a second segment of the hollow channel, the second segment extending into the body of the microneedle from a bevel opening proximate the tip of the at least one microneedle;

wherein the at least one second projection comprises a second longitudinal axis;

wherein the second projection is shaped and dimensioned to define the tip portion;

contacting at least the first mold half or the second mold half with moldable material;

inserting the at least one second projection into the cavity opening so that the first projection is substantially aligned with the second projection; and

forming the article;

wherein, the second projection causes the tip portion of the at least one microneedle to comprise a tip, a first bevel face oriented diagonally with respect to the central axis and extending through about 75% to about 95% of the body diameter, a second bevel face oriented substantially perpendicular to the central axis and intersecting the first bevel face, a bevel opening defined by a first edge of the first bevel face and a second edge of the second bevel face, and a hollow channel that extends axially into the body from the bevel opening

wherein, the second projection causes formation of the tip portion of the at least one microneedle such that the second bevel face extends through no more than about 25% of the body diameter.

14. The method of claim 13, wherein the moldable material comprises a metal, a ceramic material, or a polymeric material.

15. The method of claim 13, wherein the second projection is inserted into the at least one cavity before contacting at least the first mold half or the second mold half with the moldable material.

16. The method of claim 13, wherein at least the first mold half or the second mold half is contacted with the moldable material before inserting the second projection into the at least one cavity.

17. The method of claim 13, wherein the at least one cavity has a cavity aspect ratio (cavity length to cavity base width) of at least 1.5 to 1.

18. The method of claim 13, wherein the first mold half comprises a plurality of the at least one cavities, wherein the second mold half comprises a plurality of the at least one second projections, wherein the plurality of second projections is aligned to be inserted simultaneously into the plurality of cavities.