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

• US 8,900,186 B2
• Filed: 02/12/2009
• Issued: 12/02/2014
• Est. Priority Date: 09/12/2001
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Martin, Frank E., Kaestner, Scott A.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): SCHELL, LAURA C
• Application Number:
  US12/379,078
• Publication Number:
  US 20090157041A1
• Time in Patent Office: 2,119 Days
• Field of Search: 604/115, 604/117, 604/181, 604/183, 604/187, 604/200, 604/201, 604/205, 604/206, 604411- 4, 604/272
• 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 substance delivery device, comprising:

a supply housing having an outlet;

a single cartridge in said supply housing containing a substance and having a septum at a first end and a stopper having a distal face at a second end to seal said cartridge, said stopper having a proximal face being positioned to engage a plunger having a distal face;

a hub housing having a proximal end and a distal end, said distal end having a skin contact surface and at least one microneedle extending from said skin contact surface, said proximal end removably coupled to said outlet of said supply housing and having a piercing member oriented to pierce said septum, said piercing member mounted to said hub housing so as to be removable therewith, said at least one microneedle having a length suitable for intradermal or shallow subcutaneous delivery of said substance, said microneedle being separate, and spaced, from said piercing member, said microneedle being in fluid communication with said piercing member for receiving said substance from said cartridge, a fluid flow path is defined through said hub housing, said microneedle defining the narrowmost portion of said fluid flow path; and

a drive mechanism located within said supply housing for moving said plunger and said stopper, wherein the distal face of said stopper moves a substantially equivalent distance to the distal face of said plunger toward said septum, said septum being substantially free of deflection to dispense said substance from said cartridge through said piercing member to said at least one microneedle for delivering said substance to a patient,

wherein said skin contact surface further comprises a depth limiting post to support and limit a depth of insertion for said microneedle, said post formed about said microneedle and extending above said skin contact surface.

2. A substance delivery device as claimed in claim 1, wherein said depth limiting post includes 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 1, wherein said depth limiting post has a height above said skin contact surface and a width sufficient to allow substantially complete penetration of said microneedle.

4. A substance delivery device as claimed in claim 1, wherein said skin contact surface further comprises a tensioning ring to tension patient skin during insertion of said microneedle, said ring comprising a ridge raised from said skin contact surface and concentrically located about said microneedle.

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