Microprotrusion member retainer for impact applicator

• US 20050148926A1
• Filed: 11/01/2004
• Published: 07/07/2005
• Est. Priority Date: 10/13/2000
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Keenan, Richard L., Trautman, Joseph C.
• Granted Patent: US 8,753,318 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: A61B 2017/00747 Dermatology
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A retainer (34) is provided for holding a microprotrusion member (44) for application of the microprotrusion member (44) to the stratum corneum with an impact applicator (10). The microprotrusion member (44) includes a plurality of microprotrusions (90) which penetrate the stratum corneum to improve transport of an agent across the stratum corneum.

Claims

1. An assembly for use in a stratum-corneum piercing drug delivery system, comprising:

a microprotrusion member having a plurality of stratum corneum piercing microprotrusions thereon adapted to pierce the stratum corneum to improve transdermal agent flux; and

a substantially rigid retainer,

said retainer having an interior region including a first interior region having a first diameter that extends to a first open end of said retainer and a second interior region having a second diameter that extends to a second open end of said retainer, said first and second interior regions having substantially coincident axes, said first diameter being greater than said second diameter, said intersection of said first and second interior regions forming a retainer seat, said retainer seat being adapted to receive said microprotrusion member proximate the outer periphery thereof.

27. The assembly of claim 1, including a sealed package adapted to surround said retainer and microprotrusion member assembly.

28. The assembly of claim 1, including a sterile package adapted to surround said retainer and microprotrusion member assembly.

2. An assembly for use in a stratum-corneum piercing drug delivery system, comprising:

a microprotrusion member having a plurality of stratum corneum piercing microprotrusions thereon adapted to pierce the stratum corneum to improve transdermal agent flux; and

a substantially rigid retainer,

said retainer having an interior region including a first interior region having a first diameter that extends to a first open end of said retainer and a second interior region having a second diameter that extends to a second open end of said retainer, said first open end of said retainer being adapted to be releasably attached to an applicator device, said first and second interior regions having substantially coincident axes, said first diameter being greater than said second diameter, said intersection of said first and second interior regions forming a retainer seat, said retainer seat being adapted to receive said microprotrusion member proximate the outer periphery thereof.

3. An assembly for use in a stratum-corneum piercing drug delivery system, comprising:

a microprotrusion member having a plurality of stratum corneum piercing microprotrusions thereon adapted to pierce the stratum corneum to improve transdermal agent flux;

a substantially rigid retainer, said retainer having an interior region including a first interior region having a first diameter that extends to a first open end of said retainer and a second interior region having a second diameter that extends to a second open end of said retainer, said first and second interior regions having substantially coincident axes, said first diameter being greater than said second diameter, said intersection of said first and second interior regions forming a retainer seat, said retainer seat being adapted to receive said microprotrusion member proximate the outer periphery thereof;

wherein said retainer substantially surrounds said microprotrusion member and substantially prevents contact between said microprotrusion member and the stratum corneum prior to said piercing.

4. An assembly for use in a stratum-corneum piercing drug delivery system, comprising:

a microprotrusion member having a plurality of stratum corneum piercing microprotrusions thereon adapted to pierce the stratum corneum to improve transdermal agent flux;

a substantially rigid retainer; and

an applicator device adapted to releasably engage said first open end of said retainer, said applicator device being adapted to apply said microprotrusion member to the stratum corneum with a power of at least 0.05 joules per cm² in 10 msec or less.

5. (canceled)

6. An assembly for use in a stratum-corneum piercing drug delivery system, comprising:

a microprotrusion member having a plurality of stratum corneum piercing microprotrusions thereon adapted to pierce the stratum corneum to improve transdermal agent flux, said microprotrusions including a biocompatible coating having at least one active agent contained therein;

a substantially rigid retainer adapted to releasably receive said microprotrusion member.

7-23. -23. (canceled)

24. A method of applying a microprotrusion member to the stratum corneum to facilitate transdermal delivery or sampling of an agent, the method comprising the steps of:

providing an applicator device adapted to apply said microprotrusion member;

providing a retainer releasably securing said microprotrusion member;

attaching said retainer to said applicator device;

placing said retainer and applicator device assembly on a desired site on the stratum corneum; and

applying a hold down force to the stratum corneum with said retainer and applicator device assembly, whereby a tensile force is applied to said stratum corneum site in the range of approximately 0.01-10 MPa and whereby upon application of said hold down force said applicator device activates and applies said microprotrusion member to the stratum corneum.

25. A method of applying a microprotrusion member to the stratum corneum to facilitate transdermal delivery or sampling of an agent, the method comprising the steps of:

providing an applicator device;

providing a retainer releasably securing said microprotrusion member;

attaching said retainer to said applicator device; and

applying said microprotrusion member to the stratum corneum with aid impact applicator, said applicator being adapted to activate upon application of a hold down force to the stratum corneum with said retainer and applicator device assembly said hold down force being sufficient to apply a tensile force to the stratum corneum in the range of approximately 0.01-10 MPa, said applicator device being further adapted to apply said microprotrusion member to the stratum corneum with a power of a least 0.05 joules per cm² in 10 msec. or less.

26. (canceled)