Device and method for enhancing transdermal flux of agents being delivered or sampled

• US 7,184,826 B2
• Filed: 06/17/1997
• Issued: 02/27/2007
• Est. Priority Date: 06/18/1996
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cormier, Michel J. N., Theeuwes, Felix T., Block, Barry, Amkraut, Alfred A., Neukermans, Armand P.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US08/877,155
• Publication Number:
  US 20020016562A1
• Time in Patent Office: 3,542 Days
• Field of Search: 604/20, 604/21, 604/264, 604/272, 604/891.1, 604/175, 604/239, 604/506, 607/120, 607/126, 607/127, 607/128, 607/130, 607/131, 607/152, 600/575, 600/576
• US Class Current: 604/21
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

A percutaneous agent delivery or sampling device comprising a sheet having a plurality of microblades for piercing and anchoring to the skin for increasing transdermal flux of an agent and for improving the attachment of the device to the skin.

Claims

1. A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising a sheet having a least one opening therethrough and a plurality of blades extending downward therefrom, an adhesive anchor applied to at least one surface of said sheet, wherein said adhesive anchor helps prevent said sheet from being dislodged from said body surface, and an agent delivery or sampling device connected to said sheet and positioned to deliver or sample an agent through said opening, said agent delivery or sampling device being selected from the group consisting of an electrotransport device, a passive diffusion device, an osmotic device, and a pressure driven device, and wherein a plurality of blades has a substantially identical and uniform configuration.

2. The device of claim 1, wherein said agent comprises a polypeptide or protein.

3. The device of claim 1, further comprising at least one additional anchoring means selected from the group consisting of a projection extending out from at least one blade of said plurality of blades, a barb, at least one opening extending through said plurality of blades, each one of the plurality of blades defines essentially a plane and wherein said additional anchoring means comprises a portion of said plurality of blades being oriented at an angle of about 90°

with respect to a remaining portion of said plurality of blades, and wherein each one of said plurality of blades defines essentially a plane and wherein said additional anchoring means comprises a portion of said plurality of blades being oriented at an angle within a range of about 10°

to about 89°

with respect to a remaining portion of said plurality of blades.

4. The device of claim 3, wherein said projection extends out from a plane defined by at least one blade.

5. The device of claim 1, wherein said anchor is integral with an edge of said plurality of blades and in a plane defined by said plurality of blades.

6. The device of claim 1, wherein a portion of said blades are located along a periphery of an opening through said sheet.

7. The device of claim 1, wherein a portion of said blades are located along peripheries of a plurality of openings through said sheet.

8. The device of claim 1, further comprising a plurality of second openings through said sheet.

9. The device of claim 1, wherein said device has a blade density of about 600 to about 1000 blades/cm².

10. The device of claim 1, wherein said device has a blade density of at least about 800 blades/cm².

11. The device of claim 1, wherein at least a portion of said blades has a length sufficient to pierce the stratum corneum of said body surface to a depth of at least about 25 μ

m.

12. The device of claim 1, wherein said blades are oriented approximately perpendicular to said sheet.

13. The device of claim 1, wherein said blades are oriented at an angle in a range of about 10°

to about 89°

to said sheet.

14. The device of claim 1, wherein said blades are oriented at an angle in a range of about 10°

to about 60°

to said sheet.

15. The device of claim 1, wherein at least a portion of said blades have a thickness in a range of about 7 μ

m to about 100 μ

m.

16. The device of claim 1, wherein at least a portion of said blades have a thickness in a range of about 25 μ

m to about 500 μ

m.

17. The device of claim 1, wherein said blades are composed of a material selected from the group consisting of metals, metal alloys, glasses, ceramics and rigid polymers.

18. The device of claim 1, wherein said sheet and said blades are substantially impermeable to passage of said agent.

19. The device of claim 1, wherein said blades are thinner than said sheet.

20. The device of claim 1 wherein said sheet has openings per unit area in a range of at least about 10 openings/cm² to about 1000 openings/cm².

21. The device of claim 20 having a blade density per unit area in a range of about 10 blades/cm² to about 1000 blades/cm².

22. The device of claim 21 wherein said blade density per unit area is in a range of about 600 blades/cm² to about 1000 blades/cm².

23. The device of claim 22 wherein said blade density per unit area is in a range of about 800 blades/cm² to about 1000 blades/cm².

24. The device of claim 1, having a percolation area in a range of about 0.005 to 0.05 cm²/cm² of body surface.