Device for manipulating a needle or abrader array and method of use

• US 7,186,235 B2
• Filed: 06/07/2002
• Issued: 03/06/2007
• Est. Priority Date: 06/08/2001
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank E., Evans, John D.
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US10/163,383
• Publication Number:
  US 20020188245A1
• Time in Patent Office: 1,733 Days
• Field of Search: 604/290, 604/289, 604/181, 604/185, 604/212, 604/218, 604/20, 604272-274, 604/22, 604/46, 604/47, 604/500, 604/501, 604/511, 604/512, 604/264, 604/93.01
• US Class Current: 604/22
• 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 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The present invention relates to an apparatus and method for intradermally administering a pharmaceutical composition or other substance into and through the skin of a mammalian body in a manner that avoids or eliminates excess pain and discomfort normally caused as a result of the microabraders or microneedles entering the epithelial layers beneath the stratum corneum. In a preferred embodiment, the apparatus is a microdevice with an array of microabraders or microneedles with a manipulating member.

Claims

1. A device for administering a substance to a mammal, said device comprising:

a top wall;

a bottom wall spaced apart from said top wall and having a substantially planar outer surface;

a plurality of projecting structures extending outwardly from said substantially planar surface from about 10 microns to about 1.5 mm;

side walls joining said top wall and said bottom wall, said top wall, bottom wall and side walls defining a reservoir for said substance to be delivered;

a device manipulating member which is deformable attached to at least one wall selected from said side walls, said top wall and combinations thereof and extending outward therefrom, said manipulating member having a dimension sufficient to grip and control said device; and

at least one passageway in fluid communication with said reservoir, wherein said at least one wall is deformable.

2. The device of claim 1, wherein said manipulating member is defined by the exterior region of said side walls with said top wall defining an end of said manipulating member.

3. The device of claim 1, wherein said at least one passageway passes through each of said projecting structures.

4. The device of claim 1, wherein said projecting structures are substantially solid and said at least one passageway is in fluid communication with said substantially planar surface.

5. The device of claim 4, wherein said at least one passageway is in fluid communication with said projecting structures.

6. The device of claim 1, wherein said projecting structures have a length of from about 100 microns to about 250 microns.

7. The device of claim 1, wherein said projecting structures comprise an array of needle structures.

8. The device of claim 1, wherein said projecting structures comprise an array of structures having a length sufficient for penetrating only the stratum corneum by abrading.

9. The device of claim 1, wherein said reservoir contains a pharmaceutical composition.

10. The device of claim 1, wherein said manipulating member is hollow and defines a substantially sealed chamber, wherein said top wall is deformable whereby deforming said manipulating member applies a pressure against said top wall to deform said top wall and thereby dispense a substance from said reservoir.

11. A method of delivering a substance to a mammal comprising the steps of:

placing the device for administering a substance of claim 1 in contact with the skin of the mammal;

applying sufficient force to said device to cause said projecting structures of said device to penetrate the stratum corneum layer of said skin; and

applying sufficient internal pressure to said substance in said reservoir of the device thereby dispensing said substance from said reservoir to said projecting structures and delivering said substance below the stratum corneum layer of the skin, wherein said internal pressure is generated by deforming a portion of said device wherein said portion is selected from said at least one wall, said manipulating member and combinations thereof.

12. The method of claim 11, wherein said projections comprise an array of microneedles having an axial passage in communication with said reservoir.

13. The method of claim 11, wherein said projections have a length of from about 80 to about 250 microns.

14. The method of claim 11, wherein said method further comprises moving said device whereby said projecting structures abrade said skin and penetrate into said stratum corneum.

15. The method of claim 11, wherein said manipulating member is a handle having a dimension to grip said device.

16. The method of claim 11, wherein said top wall is made of a flexible material and said projecting structures are hollow members having an axial passage in communication with said reservoir, said method comprising applying a downward pressure on said top wall to deflect said top wall into said reservoir and to dispense said substance from said reservoir.

17. A device for administering a substance to a mammal, said device comprising:

a top wall;

a bottom wall spaced apart from said top wall and having a substantially planar outer surface;

a plurality of projecting structures extending a pre-selected distance outwardly from said substantially planar surface from about 10 microns to about 1.5 mm;

side walls joining said top wall and said bottom wall, said top wall, bottom wall and side walls defining a fluid conduit, said fluid conduit in fluid communication with said projecting structures;

a device manipulating member attached to said top wall and extending outwardly therefrom, said manipulating member having a dimension sufficient to grip and control said device;

said manipulating member having a deformable portion;

said manipulating member housing a reservoir and at least one passageway in selectable fluid communication with said fluid conduit, wherein selective fluid communication said reservoirs and said fluid conduit allows said substance to communicate with said projecting structures via said fluid conduit.

18. The device of claim 17, wherein selectable fluid communication is enabled by a pre-selected pressure applied to said reservoir by deformation of a portion of said manipulating member, thereby dispensing said substance from said reservoir to said fluid conduit.

19. The device of claim 17, wherein said manipulating member is defined by the exterior region of said side walls with said top wall defining an end of said manipulating member.

20. The device of claim 17, wherein said at least one passageway passes through each of said projecting structures.

21. The device of claim 17, wherein said projecting structures are substantially solid and said at least one passageway is in fluid communication with said substantially planar surface.

22. The device of claim 21, wherein said at least one passageway is in fluid communication with said projecting structures.

23. The device of claim 17, wherein said projecting structures have a length of from about 100 microns to about 250 microns.

24. The device of claim 17, wherein said projecting structures comprise an array of needle structures.

25. The device of claim 17, wherein said projecting structures comprise an array of structures having a length sufficient for penetrating only the stratum corneum by abrading.

26. The device of claim 17, wherein said reservoir contains a pharmaceutical composition.

27. The device of claim 17, wherein said manipulating member is hollow and defines a substantially sealed chamber, wherein said top wall is deformable whereby deforming said manipulating member applies a pressure against said top wall to deform said top wall and thereby dispense a substance from said reservoir.