Apparatus and method for piercing skin with microprotrusions

• US 20050234401A1
• Filed: 03/28/2005
• Published: 10/20/2005
• Est. Priority Date: 10/13/2000
• Status: Active Grant

• Current Assignee: Ahmad P. Samiee, James A. Matriano, Joseph C. Trautman, Michael J.N. Cormier, Peter E. Daddona, Richard L. Keenan, Weiqi Lin
• Original Assignee: Ahmad P. Samiee, James A. Matriano, Joseph C. Trautman, Michael J.N. Cormier, Peter E. Daddona, Richard L. Keenan, Weiqi Lin
• Inventors: Cormier, Michael J.N., Daddona, Peter E., Trautman, Joseph C., Keenan, Richard L., Samiee, Ahmad P., Lin, WeiQi, Matriano, James A.
• Granted Patent: US 7,798,987 B2
• Time in Patent Office: Days
• US Class Current: 604/117
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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 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

1-15. -15. (canceled)

16. A device for forming one or more microslits through the stratum corneum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface; and

a microprotrusion member having one or more stratum comeum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum comeum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.

17. A device for forming one or more microslits through the stratum comeum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

said applicator being driven by an energy source selected from the group consisting of a biasing member, pressure, electricity and magnetism

a microprotrusion member having one or more stratum corneum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.

18. A device for forming one or more microslits through the stratum corneum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

said applicator being driven by an energy source selected from the group consisting of a spring, pressure, electricity and magnetism; and

a microprotrusion member having one or more stratum corneum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.

19. A device for forming one or more microslits through the stratum comeum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

said applicator being driven by an energy source selected from the group consisting of a spring, pressure, electricity and magnetism;

said spring being an impact spring and capable of applying an impact having a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less; and

a microprotrusion member having one or more stratum corneum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.

20. A device for forming one or more microslits through the stratum corneum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface; and

a microprotrusion member having one or more stratum corneum piercing microblades, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.

21. A device for forming one or more microslits through the stratum corneum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

a microprotrusion member having one or more stratum corneum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum comeum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less; and

a hold down spring for achieving a hold down force required for device activation.

22. A device for forming one or more microslits through the stratum comeum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

a microprotrusion member having one or more stratum comeum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less; and

a hold down spring;

said hold down spring requiring a hold down force of at least 0.5 kg be applied to the applicator before activation of said applicator.

23. A device for forming one or more microslits through the stratum comeum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

a microprotrusion member having one or more stratum comeum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum comeum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less;

a hold down spring;

said hold down spring requiring a hold down force of at least 0.5 kg be applied to the applicator before activation of said applicator; and

an indicator which indicates when a predetermined hold down force is applied to said applicator.

24. A device for forming one or more microslits through the stratum comeum through which an agent can be delivered or sampled, comprising:

an applicator having a contacting surface;

a microprotrusion member having one or more stratum corneum piercing microprotrusions, the microprotrusion member being releasably mounted on said applicator, wherein said applicator, once activated, brings said contacting surface into contact with said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less;

a hold down spring;

said hold down spring requiring a hold down force of at least 0.5 kg be applied to the applicator before activation of said applicator; and

an indicator which indicates when a predetermined hold down force is applied to said applicator;

wherein said indicator provides an audible, tactile, or visible signal to indicate when said predetermined hold down force is applied.

25-38. -38. (canceled)

39. A device for impacting a microprotrusion member, said microprotrusion member having thereon one or more microprotrusions, said microprotrusion member adapted to form one or more microslits through the stratum corneum through which an agent can be delivered or sampled, said device comprising:

an applicator having a contacting surface; and

said applicator adapted to cause said contacting surface to impact said microprotrusion member in such a manner that said microprotrusion member strikes the stratum corneum with a power of at least 0.05 joules per cm² of microprotrusion member in 10 milliseconds or less.