Microneedle-based pen device for drug delivery and method for using same

• US 7,556,615 B2
• Filed: 09/11/2002
• Issued: 07/07/2009
• Est. Priority Date: 09/12/2001
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank E., Pettis, Ronald J., Kaestner, Scott A.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Witczak; Catherine N
• Application Number:
  US10/238,958
• Publication Number:
  US 20030050602A1
• Time in Patent Office: 2,491 Days
• Field of Search: 604/115, 604/117, 604/181, 604/183, 604/187, 604/200, 604/201, 604/205, 604/206, 604411-414
• US Class Current: 604/117
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• CPC Class Codes: A61M 5/31548 Mechanically operated dose setting member
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Claims

1. A microneedle delivery device, comprising:

a hub housing having a proximate end and a distal end with a skin contact surface, said proximate end having a coupling member for removably coupling said device to a supply reservoir containing a substance to be delivered to a patient;

a fluid communication member located at said proximate end of said housing and having a length sufficient to communicate with said supply reservoir, said fluid communication member mounted to said housing so as to be removable therewith, said fluid communication member terminating with a piercing member;

a microneedle extending from said skin contact surface and having a length sufficient to penetrate the skin of a patient to a selected depth, said microneedle being separate, and spaced, from said fluid communication member, wherein a fluid flow path is defined between said supply reservoir and said selected depth, said microneedle defining the narrowmost portion of said fluid flow path; and

a depth limiting member extending from said skin contact surface for limiting a depth of penetration of said microneedle into said skin.

2. A microneedle delivery device as claimed in claim 1, wherein said depth limiting member comprises a post having an axial dimension and an outer face, and wherein said microneedle extends axially from said outer face.

3. A microneedle delivery device as claimed in claim 2, wherein said depth limiting post has a height above said patient contact surface and a width sufficient to allow substantially complete penetration of said microneedle.

4. A microneedle delivery device as claimed in claim 1, wherein said skin contact surface further comprises at least one tensioning member for tensioning said skin during insertion of said microneedle into said skin.

5. A microneedle delivery device as claimed in claim 4, wherein said tensioning member comprises a ridge extending from said skin contact surface and concentrically located about said microneedle.

6. A microneedle delivery device as claimed in claim 4, wherein said tensioning member extends from said contact surface a height of less than or equal to said height of said depth limiting post.

7. A microneedle delivery device as claimed in claim 1, wherein said device is further adapted to allow delivery of said substance of said supply reservoir from said supply reservoir to said selected depth at a rate substantially equivalent to delivery via a single 31 gauge needle.

8. A microneedle delivery device as claimed in claim 1, wherein said proximate end includes an engagement opening defining said coupling member.

9. A microneedle delivery device as claimed in claim 1, wherein said coupling member is selected from the group consisting of a threaded fitting, a luer fitting and a snap fit fitting.

10. A microneedle delivery device as claimed in claim 1, wherein said skin contact surface is formed at an angle of 90 degrees or less relative to a center line of said hub housing.

11. A microneedle delivery device as claimed in claim 1, wherein said piercing member is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.

12. A microneedle delivery device as claimed in claim 1, wherein said piercing member comprises a needle.

13. A microneedle delivery device as claimed in claim 1, wherein said piercing member comprises a 31 gauge needle.

14. A microneedle delivery device as claimed in claim 1, wherein said microneedle is made from a material selected from the group consisting of stainless steel, silicon, silicon compound and plastic.

15. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 30 gauge.

16. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 31 gauge.

17. A microneedle delivery device as claimed in claim 1, wherein said microneedle comprises a microneedle of at least 34 gauge.

18. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 0.3 mm to about 5.0 mm.

19. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 0.3 mm to about 2.0 mm to access intradermal tissue space.

20. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 0.75 mm to about 1.70 mm to access intradermal tissue space.

21. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 2.0 mm to about 5.0 mm to access shallow subcutaneous tissue space.

22. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 1.7 mm to about 5.0 mm to access shallow subcutaneous tissue space.

23. A microneedle delivery device as claimed in claim 1, wherein said microneedle has an exposed length ranging from about 1.7 mm to about 3.0 mm to access shallow subcutaneous tissue space.

24. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of said microneedles extending from said skin contact surface.

25. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of said depth limiting members extending from said skin contact surface.

26. A microneedle delivery device as claimed in claim 1, wherein said device comprises a plurality of skin tensioning members extending from said skin contact surface.