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

• US 20020188245A1
• Filed: 06/07/2002
• Published: 12/12/2002
• 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.
• Granted Patent: US 7,186,235 B2
• Time in Patent Office: Days
• US Class Current: 604/46
• 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;

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 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, further comprising a rupturable membrane adjacent said at least one passageway.

3. The device of claim 1, wherein at least said manipulating member is deformable.

4. 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 and said bottom wall defining a second end of said manipulating member.

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

6. 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.

7. The device of claim 6, wherein said at least one passageway is in fluid communication with said projecting structures.

8. The device of claim 1, wherein said projecting structures have a length of from about 10 microns to about 1.5 mm.

9. The device of claim 8, wherein said projecting structures have a length of from about 100 microns to about 250 microns.

10. The device of claim 1, wherein said projecting structures comprise an array of needle-like structures.

11. 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.

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

13. The device of claim 3, 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.

15. The device of claim 14, wherein said finger-cup is made from an elastic material.

16. The device of claim 14, wherein said finger-cup is dimensioned to accommodate at least one finger of a user'"'"'s hand.

17. The device of claim 14, wherein said projecting structures comprise an array of microneedles.

18. The device of claim 14, wherein said at least one passageway passes through each of said projecting structures.

19. The device of claim 14, wherein said projecting structures are substantially solid and said at least one passageway is in fluid communication with said substantially planar surface.

20. The device of claim 14, wherein said at least one passageway is in fluid communication with said projecting structures.

21. The device of claim 14, wherein said microneedles have a length of about 10 microns to about 1.5 mm.

22. The device of claim 21, wherein said microneedles have a length of about 100 microns to about 250 microns.

24. The method of claim 23, wherein said projections comprise an array of microneedles having an axial passage in communication with said reservoir.

25. The method of claim 23, wherein said projections have a length of about 10 microns to about 1.5 mm.

26. The method of claim 23, wherein said projections have a length of from about 80 to about 250 microns.

27. The method of claim 23, wherein said method further comprises moving said device whereby said projecting structures abrade said skin and penetrate into said stratum corneum.

28. The method of claim 23, wherein said manipulating member is a handle having a dimension to grip said device.

29. The method of claim 23, wherein said manipulating member is a finger-cup coupled to said top surface and dimensioned to receive at least one finger of a user.

30. The method of claim 23, 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.

14. A device for delivering a substance to a mammal, comprising:

a top wall;

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

projecting structures extending outward from said substantially planar surface;

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 finger-cup attached to at least one wall selected from said side walls, said top wall and combinations thereof;

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

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

placing a microdevice in contact with the skin of a mammal, wherein said microdevice comprises a substantially planar surface having a plurality of projecting structures extending outwardly therefrom, a top wall spaced apart from said planar surface, side walls joining said top wall and said planar surface to define a reservoir containing a substance, a manipulating member attached to at least one walls selected from said side walls, said top wall and combinations thereof, at least one passageway in fluid communication with said reservoir, wherein said at least one wall is deformable;

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

applying sufficient internal pressure to said substance in said reservoir 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 microdevice wherein said portion is selected from said at least one wall, said manipulating member and combinations thereof.

31. 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;

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;

manipulating member attached to at least one wall selected from said side walls, said top wall and combinations thereof and extending outward therefrom, said means for manipulating having a shape and dimension sufficient to allow a user of said device to grip and control said device;

a means for fluid communication with said reservoir and said plurality of projecting structures; and

means for dispensing a substance contained in said reservoir, wherein said means for dispensing is responsive to a predetermined pressure threshold.

32. The device of claim 31, further comprising means for retaining said substance contained in said reservoir.

33. The device of claim 32, wherein said means for retaining is responsive to said means for dispensing.

34. The device of claim 31, wherein said means for retaining comprises a rupturable membrane.

35. The device of claim 31, wherein said means for dispensing comprises a deformable manipulating member.