What is claimed is:
1. A microabrader for delivering a substance into skin, said microabrader comprising an abrading surface, wherein said abrading surface comprises frustoconical or frustopyramidal microprotrusions comprising at least one scraping edge and projecting from said abrading surface, and an effective amount of said substance.
2. The microabrader of claim 1 that further comprises a base comprising an abrading facet adapted to receive or integral with said abrading surface.
3. The microabrader of claim 2 that further comprises a handle attachment facet suitable for attaching a handle to said base.
4. The microabrader of claim 2 that further comprises a handle that is integral with or detachable from said base.
5. The microabrader of claim 2, wherein said abrading surface projects from said abrading facet.
6. The microabrader of claim 3, wherein said handle attachment facet and said abrading facet are disposed substantially parallel to one another on opposite sides of said base.
7. The microabrader of claim 3, wherein said base comprises a smooth edge connecting said abrading facet to said handle attachment facet.
8. The microabrader of claim 7, wherein said smooth edge forms an arc connecting said abrading facet to said handle attachment facet.
9. The microabrader of claim 7, wherein said abrading facet is substantially circular of a first diameter, and said handle attachment facet is substantially circular of a second diameter, and wherein said second diameter is greater than said first diameter.
10. The microabrader of claim 4, wherein said handle is removable.
11. The microabrader of claim 1, wherein said microprotrusions are at least partially coated with said substance to be delivered.
12. The microabrader of claim 1 having a reservoir containing said substance.
13. The microabrader of claim 1, wherein said microprotrusions are of a length sufficient to penetrate into the stratum corneum layer of said skin.
14. The microabrader of claim 1, wherein said microprotrusions comprise at least two scraping edges.
15. The microabrader of claim 1, wherein said microprotrusions comprise at least three facets and wherein the intersection of any two of said facets forms a scraping edge.
16. The microabrader of claim 1, wherein said microprotrusions have microprotrusion bases and are constructed and arranged in a pattern such that the distance between the centers of said microprotrusion bases is at least two times the length of said microprotrusion.
17. The microabrader of claim 1, wherein said microprotrusions are constructed and arranged in said pattern such that the distance between the centers of said bases is at least five times the length of said microprotrusion.
18. The microabrader of claim 1, wherein the microprotrusions are arranged in a pattern.
19. The microabrader of claim 18 wherein said pattern consists of rows and columns.
20. The microabrader of claim 18, wherein said pattern is a circular pattern.
21. The microabrader of claim 18, wherein said pattern is a random pattern.
22. The microabrader of claim 16, wherein said bases of said microprotrusions are spaced apart to form valleys between said microprotrusions.
23. The microabrader of claim 1 having a coating of a bioactive substance on said abrading surface.
24. The microabrader of claim 23, wherein said bioactive substance is a medicament.
25. The microabrader of claim 23, wherein said bioactive substance is a vaccine.
26. The microabrader of claim 23, wherein said bioactive substance is an allergen.
27. The microabrader of claim 23, wherein said bioactive substance is a gene therapeutic agent.
28. The microabrader of claim 1, wherein the length of said microprotrusions are greater than the depth to which they penetrate into said skin.
29. The microabrader of claim 1, wherein said microprotrusions are of a length sufficient to penetrate through the stratum corneum layer of said skin when used to abrade said skin.
30. The microabrader of claim 1, wherein the length of said microprotrusions is from about 5 to about 500 microns.
31. The microabrader of claim 1, wherein the length of said microprotrusions is from about 30 to about 300 microns.
32. The microabrader of claim 1, wherein the length of said microprotrusions is from about 75 to about 250 microns.
33. The microabrader of claim 1, wherein the length of said microprotrusions is from about 180 to about 220 microns.
34. The microabrader of claim 1 wherein said abrading surface is plastic.
35. The microabrader of claim 1 wherein said abrading surface is silicon.
36. A method for delivering a substance into skin comprising the steps of moving a microabrader across said skin to produce an abraded area, wherein said microabrader comprises an abrading surface, wherein said abrading surface comprises frustoconical or frustopyramidal microprotrusions that comprise at least one scraping edge projecting from said abrading surface, and applying said substance to the abraded area.
37. The method of claim 36 wherein said substance is applied prior to microabrasion.
38. The method of claim 36 wherein said substance is applied during microabrasion.
39. The method of claim 36 wherein said substance is applied following microabrasion.
40. The method of claim 39, wherein said microprotrusions are at least partially coated with said substance to be delivered.
41. The method of claim 36, wherein said microprotrusions are of a length sufficient to penetrate into the stratum corneum layer of said skin.
42. The method of claim 36, wherein said microprotrusions comprise at least two scraping edges.
43. The method of claim 36, wherein said microprotrusions comprise at least three facets and wherein the intersection of any two of said facets forms a scraping edge.
44. The method of claim 36, wherein said microprotrusions further comprise a flat tip.
45. The method of claim 36, wherein said microprotrusions have microprotrusion bases and are constructed and arranged in a pattern such that the distance between the centers of said microprotrusion bases is at least two times the length of said microprotrusion.
46. The method of claim 36, wherein said microprotrusions are constructed and arranged in a pattern such that the distance between the centers of said bases is at least five times the length of said microprotrusion.
47. The method of claim 36, wherein said microprotrusions are arranged in a uniform pattern.
48. The method of claim 45, wherein said bases of said microprotrusions are spaced apart to form valleys between said microprotrusions.
49. The method of claim 36 wherein said microabrader contains a bioactive substance on said abrading surface.
50. The method of claim 49, wherein said bioactive substance is a medicament.
51. The method of claim 36, wherein said microabrader is moved across said skin at least once.
52. The method of claim 36, wherein said microabrader is moved across said skin in alternating directions.
53. The method of claim 36 wherein the substance delivered is a bioactive substance.
54. The method of claim 53 wherein said substance is an allergen.
55. The method of claim 53 wherein said substance is a gene therapeutic agent.
56. The method of claim 53 wherein said substance is a vaccine.
57. The method of claim 56 wherein said vaccine comprises a live, attenuated virus or viral vector.
58. The method of claim 56 wherein said vaccine comprises an inactivated or killed virus.
59. The method of claim 56 wherein said vaccine comprises an inactivated or killed bacterium.
60. The method of claim 56 wherein said vaccine comprises a nucleic acid.
61. The method of claim 56 wherein said vaccine additionally comprises a protein or peptide encoded by said nucleic acid.
62. The method of claim 56 wherein said vaccine further comprises an adjuvant.
63. The method of claim 56 wherein said vaccine comprises a live, non-attenuated virus or bacteria.
64. The method of claim 56 wherein said vaccine comprises a polysaccharide or polysaccharide-conjugate.
65. The method of claim 56 wherein said vaccine comprises a protein or peptide.
66. The method of claim 65 wherein said vaccine further comprises an adjuvant.
67. A kit comprising at least one microabrader according to claim 1.
68. The kit of claim 67 wherein the dosage is coated on the surface of the microabrader.
69. The kit of claim 67 wherein the dosage is contained in a reservoir integrated with said microabrader.
70. The kit of claim 67 wherein the dosage is separately packaged within said kit.
71. A device for delivering a substance into skin comprising an abrading surface coated with the substance and a reservoir containing a reconstituting liquid in fluid communication with the abrading surface.
72. The device of claim 71 wherein the abrading surface is an array comprising a plurality of microprotrusions.
73. The device of claim 71 wherein the substance is coated on the microprotrusions.
74. The device of claim 71 wherein the reservoir communicates with the abrading surface via channels through microprotrusions on the abrading surface.
75. The device of claim 71 wherein the reservoir communicates with the abrading surface via channels between microprotrusions on the abrading surface.
76. The device of claim 71 wherein the reservoir communicates with the abrading surface by means of a porous material between the reservoir and the abrading surface.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A bicycle helmet, comprising:
a shell configured to protect the head of a rider;
a first pair of straps connected to a first side of the shell;
a second pair of straps connected to a second side of the shell;
a pair of strap adjustment assemblies cooperating with said first pair of straps and said second pair of straps, respectively, each member of said pair of strap adjustment assemblies comprising:
a base having a first face and a second face, said base defining a first pivot surface defining an axis of rotation, said second face of said base defining a curved first guide surface and a curved second guide surface to one side of said axis of rotation and a third guide surface to the other side of said axis of rotation; and
a release lever having an arm section and a pivot section, said pivot section defining a second pivot surface, said release lever further comprising a protuberance defining an engagement surface, said first pivot surface and said second pivot surface cooperating to permit manual manipulation of said arm section to rotate said lever about said axis between a first position wherein said engagement surface of said protuberance is unopposed and extends outward a first distance in the direction of said first face and a second position wherein said engagement surface of said protuberance extends less than said first distance in the direction of said first face,
said base and said release lever defining a first path for a first strap extending over said second face side of said first guide surface, over said first face side of said protuberance and over said second face side of said third guide surface, said base and said release member further defining a second path for a second strap extending over said second face side of said second guide surface, over said first face side of said protuberance and over said second face side of said third guide surface.
2. The bicycle helmet of claim 1, wherein a portion of said first guide surface, said second guide surface and said third guide surface are contained in a single plane.
3. The bicycle helmet of claim 2, wherein when said release lever is in said second position, said release member extends from said axis of rotation past said third guide surface, to facilitate gripping of said release lever to move said release lever between said first position and said second position.
4. The bicycle helmet of claim 1, wherein said first position and said second position are separated by between 110 and 170 degrees about said axis of rotation.
5. The bicycle helmet of claim 1, wherein said base defines an annular member and said release lever surrounds roughly one half of said base when said release member is in said second position.
6. The bicycle helmet of claim 1, wherein said protuberance is spaced below said first guide surface, said second guide surface, and said third guide surface when said release lever is in said second position so that the base and said protuberance define a slot configured to receive said first strap and said second strap.
7. The bicycle helmet of claim 6, wherein said spacing between said protuberance and said first guide surface, said second guide surface, and said third guide surface is generally equal to or greater than the combined thicknesses of said first strap and said second strap.
8. A helmet, comprising:
a shell configured to protect the head of a rider;
a first pair of straps connected to a first side of the shell;
a second pair of straps connected to a second side of the shell;
a pair of strap adjustment assemblies cooperating with said first pair of straps and said second pair of straps, respectively, each member of said pair of strap adjustment assemblies comprising:
a base having a first face and a second face, said base defining a first pivot surface defining an axis of rotation, said second face of said base defining a first guide surface and a second guide surface to one side of said axis of rotation and a third guide surface to the other side of said axis of rotation; and
a release lever having an arm section and a pivot section, said pivot section defining a second pivot surface, said release lever further comprising a protuberance defining an engagement surface, said first pivot surface and said second pivot surface cooperating to permit manual manipulation of said arm section to rotate said lever about said axis between a first position wherein said engagement surface of said protuberance extends outward a first distance in the direction of said first face and a second position wherein said engagement surface of said protuberance extends less than said first distance in the direction of said first face,
said base and said release lever defining a first path for a first strap extending over said second face side of said first guide surface, over said first face side of said protuberance and over said second face side of said third guide surface, said base and said release member further defining a second path for a second strap extending over said second face side of said second guide surface, over said first face side of said protuberance and over said second face side of said third guide surface; and
wherein the portion of the base opposite the distal end of the release member is exposed to provide a secondary gripping surface to facilitate rotation of said release lever around said axis by squeezing said distal end of said release lever and said opposite portion of said base together with a finger and thumb.
9. The helmet of claim 8, the base of each of said strap adjustment assemblies further comprising a pair of opposing sides straddling one of said pairs of straps, each of the sides having an outwardly facing surface adapted for gripping by the wearer of the helmet for sliding the strap adjustment assembly along the straps after said release lever is located in the second position.
10. The helmet of claim 8, wherein a portion of said first guide surface, said second guide surface and said third guide surface are contained in a single plane and when said protuberance is in said first position, said engagement surface of said protuberance is accessible from a direction perpendicular to said plane.
11. The helmet of claim 10, wherein when said release lever is in said second position, said release member extends from said axis of rotation past said third guide surface, to facilitate gripping of said release lever to move said release lever between said first position and said second position.
12. The helmet of claim 8, wherein said first position and said second position are separated by between 110 and 170 degrees about said axis of rotation.
13. The helmet of claim 8, wherein said base defines an annular member and said release lever surrounds roughly one half of said base when said release member is in said second position.
14. A strap adjustment assembly for securing a pair of helmet straps, comprising:
a base having a first face and a second face, said base defining a first pivot surface defining an axis of rotation, said second face of said base defining a first guide surface and a second guide surface to one side of said axis of rotation and a third guide surface to the other side of said axis of rotation; and
a release lever having an arm section and a pivot section, said pivot section defining a second pivot surface, said release lever further comprising a protuberance defining an engagement surface, said first pivot surface and said second pivot surface cooperating to permit manual manipulation of said arm section to rotate said lever about said axis between a first position wherein said engagement surface of said protuberance extends outward a first distance in the direction of said first face and a second position wherein said engagement surface of said protuberance extends less than said first distance in the direction of said first face, and
wherein the portion of the base opposite the distal end of the release member is exposed to provide a secondary gripping surface to facilitate rotation of said release lever around said axis by squeezing said distal end of said release lever and said opposite portion of said base together with a finger and thumb or two fingers and wherein a portion of said first guide surface, said second guide surface and said third guide surface are contained in a single plane and when said protuberance is in said first position, said engagement surface of said protuberance is accessible from a direction perpendicular to said plane.
15. The strap adjustment assembly of claim 14, wherein a portion of said engagement surface of said protuberance is spaced below said first guide surface, said second guide surface, and said third guide surface and generally parallel to a portion of one of said first guide surface, said second guide surface, and said third guide surface when said release lever is in said second position, the portion of said engagement surface and said base define an elongated slot configured to receive a pair helmet straps.
16. The strap adjustment assembly of claim 15, wherein said elongated slot is generally rectangular and said spacing between the portion of said engagement surface of said protuberance and said first guide surface, said second guide surface, and said third guide surface is generally equal to or greater than the thickness of at least one of the straps of said pair of helmet straps.