Apparatus and method for piercing skin with microprotrusions

• US 7,419,481 B2
• Filed: 03/28/2005
• Issued: 09/02/2008
• Est. Priority Date: 10/13/2000
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Daddona, Peter E., Trautman, Joseph C., Cormier, Michel J. N., Keenan, Richard L., Lin, WeiQi, Matriano, James A., Samiee, Ahmad P.
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US11/092,800
• Publication Number:
  US 20060142691A1
• Time in Patent Office: 1,254 Days
• Field of Search: 604/890.1, 604 46- 48, 604/173, 604/500, 604/501, 604/506, 604136-139, 606/181, 606183-189, 600/322, 600/325
• US Class Current: 604/500
• 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: 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 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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 37/0015 by using microneedles

Abstract

A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm² of the microprotrusion member (44) in 10 msec or less.

Claims

1. A method of transferring an agent through the stratum corneum of a subject, comprising the steps of:

providing a microprotrusion member having one or more stratum corneum-piercing microprotrusions;

placing said microprotrusion member proximate a skin site on the subject;

applying a hold down force to cause the stratum corneum to be stretched;

striking said microprotrusion member with an impact force, whereby said microprotrusion member imparts an energy on impact with the stratum corneum in the range of approximately 0.05-0.3 joules per cm² of said microprotrusion member over a penetration period no greater than 10 milliseconds, and whereby at least one of said stratum corneum-piercing microprotrusions forms a microslit through the stratum corneum of the subject; and

delivering or sampling or transferring the agent through said microslits microslit.

2. A method of transferring an agent through the stratum corneum of a subject, comprising the steps of:

providing a microprotrusion member having one or more stratum corneum-piercing microprotrusions;

applying a hold down force to cause the stratum corneum to be stretched;

striking said microprotrusion member with an impact force, whereby said microprotrusion member imparts an energy on impact with the stratum corneum in the range of approximately 0.1-0.3 joules per cm² of said microprotrusion member over a penetration period in the range of 1-10 milliseconds, and whereby at least one of said stratum corneum-piercing microprotrusions forms a microslit through the stratum corneum of the subject; and

transferring the agent through said microslit.

3. A method of transferring an agent through the stratum corneum of a subject, comprising the steps of:

providing a microprotrusion member having one or more stratum corneum-piercing microprotrusions;

providing an impact applicator adapted to provide a first impact force;

placing said microprotrusion member proximate a skin site on the subject;

placing said impact applicator proximate said skin site in operational relationship with said microprotrusion member;

applying a hold down force to cause the stratum corneum to be stretched;

actuating said impact applicator to impart said first impact force to said microprotrusion member, whereby said microprotrusion member imparts an energy on impact with the stratum corneum in the range of 0.1-0.3 joules per cm² of said microprotrusion member over a penetration period in the range of 1-10 milliseconds, and whereby at least one of said stratum corneum-piercing microprotrusions forms a microslit through the stratum corneum of the subject; and

transferring the agent through said microslit.