Method and apparatus for the transdermal administration of a substance

• US 6,623,457 B1
• Filed: 09/22/1999
• Issued: 09/23/2003
• Est. Priority Date: 09/22/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Rosenberg, Zeil B.
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): Han, Mark K.
• Application Number:
  US09/401,452
• Time in Patent Office: 1,462 Days
• Field of Search: 604/258, 604/890.1, 604/85, 604/183, 604/184, 604/239, 604/261, 604/180, 604/263, 604/192, 604/191, 604/272, 604/80, 604/173, 424/449, 424/483
• US Class Current: 604/191
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• 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

Abstract

A transdermal delivery device includes a plurality of microneedles for injecting a substance such as a pharmaceutical agent into or below the stratum corneum of the skin. The device has housing formed from a top and bottom wall to define a chamber for containing a pharmaceutical agent. An inlet port is provided in the top wall of the housing for supplying the pharmaceutical agent to the chamber and directing the agent to the microneedles. The housing can have a Luer lock type fitting for coupling with a syringe having a Luer lock collar to inject the pharmaceutical agent into the housing. The housing can be divided into a plurality of chambers by an internal wall for supplying different agents simultaneously or sequentially to a patient. The microneedles have a length of about 5-250 microns and generally about 50-100 microns.

Claims

1. A delivery device for introducing a substance into or below the stratum corneum of a patient, said device comprising:

a top wall having a top surface, a bottom surface, and at least one opening extending between said top and bottom surfaces;

a bottom wall having an inner surface and an outer surface coupled to said top wall by at least one side wall and spaced from said top wall to define a reservoir therebetween for containing said substance, said bottom wall having a plurality of openings extending between said inner and outer surfaces, and said reservoir being in fluid communication with at least one of said at least one opening in said top wall;

a coupling member attached to said top wall for supplying a fluid selected from the group consisting of said substance, a diluent, and a solvent for said substance through said at least one opening in said top wall and into said reservoir with sufficient pressure to expel said fluid through said plurality of said bottom wall openings at a predetermined rate; and

a plurality of individual hollow microneedles attached to and in contact with said outer surface of said bottom wall and being in fluid communication with said openings in said bottom wall and having a length sufficient to penetrate or pierce the stratum corneum without penetrating into the dermis of said patient; and

further comprising

at least one internal wall extending between said top and bottom walls to divide said reservoir into at least two chambers, each of said chambers communicating with at least one opening in said top wall and with at least one opening in said bottom wall.

2. The device of claim 1, wherein said coupling member is a Luer lock collar.

3. The device of claim 2, further comprising a syringe removably coupled to said Luer lock collar for supplying a fluid to said reservoir and expelling the fluid through said opening in said bottom wall.

4. The device of claim 1, wherein each of said chambers includes a dry pharmaceutical agent.

5. The device of claim 4, wherein said top wall includes a coupling member attached to said top wall and surrounding said opening in said top wall.

6. The device of claim 1, further comprising a flexible film having a dimension greater than a dimension of said top wall, said film including an adhesive layer on a bottom side thereof, and being attached to said top wall by said adhesive layer and overlying said top wall and extending beyond said top wall a distance whereby said film is able to attach said device to the skin of a patient.

7. The device of claim 1, further comprising a cover removably coupled to said bottom wall and enclosing said microneedles.

8. The device of claim 7, wherein said cover includes an outer wall and at least one side wall, said side wall being frictionally attached to said delivery device.

9. The device of claim 1, wherein said reservoir contains a substantially dry pharmaceutical compound, which can be reconstituted by introducing a solvent into said reservoir.

10. The device of claim 1, wherein said microneedles are of different lengths.

11. The device of claim 1, wherein said microneedles include a tip for penetrating the stratum corneum of the skin and a fluid passage for directing a fluid from said reservoir to said tip.

12. An intraepidermal delivery device according to claim 1, wherein the length of the plurality of hollow microneedles is about 5 to 200 microns.

13. An intraepidermal delivery device according to claim 1, wherein each of the individual hollow microneedles has a width from about 15 to about 40 gauge.