Method and device for the delivery of a substance

• US 20030093040A1
• Filed: 10/29/2002
• Published: 05/15/2003
• Est. Priority Date: 10/29/2001
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Mikszta, John A., Dekker, John P. III, Brittingham, John M., Alarcon, Jason
• Application Number:
  US10/282,231
• Publication Number:
  US 20030093040A1
• Time in Patent Office: Days
• US Class Current: 604/289
• CPC Class Codes: A61B 17/54 Chiropodists' instruments , e.g. pedicure chiropractic devices A61H1/008
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

An abrasion device and method for delivery of substances into the skin comprises a microabrader for delivering a substance into the skin having a base with an abrading facet, to which an abrading surface having an arrangement of microprotrusions that have at least one scraping edge is attached, mounted, or integral with and a handle attachment facet, to which a handle or other grasping device is attached or mounted.

Claims

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.

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.

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.

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.