Hollow microneedle with bevel opening

• US 10,384,047 B2
• Filed: 07/10/2014
• Issued: 08/20/2019
• 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: Simmers, Ryan Patrick
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Fredrickson, Courtney B
• Application Number:
  US14/905,035
• Publication Number:
  US 20160166819A1
• Time in Patent Office: 1,867 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: A61B 5/685 Microneedles
• 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: B22D 25/02 by its peculiarity of shape; of works of art cylinders, pistons B22D15/02
• CPC Class Codes: B29C 2045/0094 injection moulding of small-sized articles, e.g. microarticles, ultra thin articles
• CPC Class Codes: B29C 33/005 characterised by the location of the parting line of the mould parts
• CPC Class Codes: B29C 45/00 Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor injection blow-moulding B29C49/06
• 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: B29K 2105/0058 Liquid or visquous
• 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), a first channel (170), and a second channel (176). The tip portion includes a tip (164), a beveled surface (140), and a bevel opening (172) in the beveled surface. The first channel extends axially from the bevel opening through at least a portion of the elongated body and has a first wall that is substantially aligned with the central axis. The second channel extends radially from the first channel to the bevel opening and has a second wall that is oriented substantially orthogonal to the central axis. The first channel and second channel merge to form the bevel opening.

Claims

1. An article, comprising:

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

a base;

an elongated body having a central axis;

a tip portion comprising a tip, a beveled surface, and a bevel opening in the beveled surface;

a first channel that extends axially from the bevel opening through at least a portion of the elongated body, wherein the first channel has a first wall that is substantially aligned with the central axis; and

a second channel that extends radially from the first channel, through a portion of the microneedle between the tip and a portion of the beveled surface distant from the tip and does not extend through any other portion of the microneedle, to the bevel opening, wherein the second channel has a second wall that is oriented substantially orthogonal to the central axis;

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

wherein

the beveled surface is defined by a bevel edge surrounding the beveled surface, wherein the bevel opening is defined by an opening edge surrounding the bevel opening, and wherein no portion of the opening edge is coincident with any portion of the bevel edge.

2. 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 first channel extends from the bevel opening through the elongated body to a second opening on the second side of the substrate.

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

4. The article of claim 1, wherein the tip portion comprises plurality of intersecting planes.

5. The article of claim 1, wherein a bevel face defines a first plane, wherein a first two-dimensional area defined by the bevel opening is larger than a second two-dimensional area defined by a cross-sectional area of the first channel taken along the first plane.

6. A method of use of the article of claim 1, comprising injecting fluid from the article into a body.

7. A method of use of the article of claim 1, comprising extracting fluid from a body to the article.

8. A method of making an article of claim 1 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 a 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 the tip portion of the microneedle and a second segment of the hollow channel, the second segment extending into the body of the microneedle from the 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;

wherein the second projection is shaped and dimensioned such that the first channel and second channel merge to form the bevel opening;

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

inserting the second projection into the at least one cavity.

9. The method of claim 8, wherein the second projection is inserted into the at least one cavity before contacting at least the first mold surface or the second mold surface with the moldable material.

10. The method of claim 8, wherein at least the first mold surface or the second mold surface is contacted with the moldable material before inserting the second projection into the at least one cavity.

11. The method of claim 8, wherein the moldable material comprises a metal, a ceramic, or a polymeric material.

12. The method of claim 8, wherein the at least one cavity has a cavity aspect ratio (cavity length to cavity base width) of at least 1.5 to 1.

13. The method of claim 8, 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.

14. An article, comprising:

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

a base;

an elongated body having a central axis;

a tip portion comprising a tip, a beveled surface, and a bevel opening in the beveled surface;

a first channel that extends axially from the bevel opening through at least a portion of the elongated body, wherein the first channel has a first wall that is substantially aligned with the central axis; and

a second channel that extends radially from the first channel, through a portion of the microneedle between the tip and a portion of the beveled surface distant from the tip and does not extend through any other portion of the microneedle, to the bevel opening, wherein the second channel has a second wall that is oriented substantially orthogonal to the central axis;

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

and wherein the beveled surface is defined by a bevel edge surrounding the beveled surface, wherein the bevel opening is defined by an opening edge surrounding the bevel opening, and wherein at least a portion of the opening edge is coincident with a portion of the bevel edge.

15. The article of claim 14, 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 first channel extends from the bevel opening through the elongated body to a second opening on the second side of the substrate.

16. The article of claim 14, wherein the at least one microneedle comprises a plurality of microneedles.

17. The article of claim 14, wherein the tip portion comprises plurality of intersecting planes.

18. The article of claim 14, wherein a bevel face defines a first plane, wherein a first two-dimensional area defined by the bevel opening is larger than a second two-dimensional area defined by a cross-sectional area of the first channel taken along the first plane.

19. A method of making an article of claim 14 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 a 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 the tip portion of the microneedle and a second segment of the hollow channel, the second segment extending into the body of the microneedle from the 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;

wherein the second projection is shaped and dimensioned such that the first channel and second channel merge to form the bevel opening;

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

inserting the second projection into the at least one cavity.

20. The method of claim 19, wherein the second projection is inserted into the at least one cavity before contacting at least the first mold surface or the second mold surface with the moldable material.

21. The method of claim 19, wherein at least the first mold surface or the second mold surface is contacted with the moldable material before inserting the second projection into the at least one cavity.

22. The method of claim 19, wherein the moldable material comprises a metal, a ceramic, or a polymeric material.

23. The method of claim 19, wherein the at least one cavity has a cavity aspect ratio (cavity length to cavity base width) of at least 1.5 to 1.

24. The method of claim 19, 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.