Apparatus and method for piercing skin with microprotrusions

• US 20020123675A1
• Filed: 10/12/2001
• Published: 09/05/2002
• Est. Priority Date: 10/13/2000
• Status: Active Grant

• 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., Samiee, Ahmad P., Lin, WeiQi, Matriano, James A.
• Granted Patent: US 7,131,960 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling an agent through said microslits.

2. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling a drug through said microslits.

3. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling a vaccine through said microslits.

4. A method of delivering or sampling an one or more agents through the stratum corneum, comprising:

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

providing a coating of at least one of said agents on said one or more stratum corneum piercing microprotrusion;

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling at least one of said one or more agents through said microslits;

5. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.1 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling an agent through said microslits.

6. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 1 millisecond or less; and

delivering or sampling an agent through said microslits.

7. A method of delivering or sampling a body analyte through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling a body analyte through said microslits.

8. A method of delivering or sampling a body analyte through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling glucose through said microslits.

9. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

wherein said microprotrusions have a length of less than 500 μ

m;

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling an agent through said microslits.

10. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling an agent through said microslits.

11. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum activating an impact applicator so that said microprotrusions impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less; and

delivering or sampling an agent through said microslits.

12. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum activating an impact applicator so that said microprotrusions impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less;

wherein the impact applicator is activated when the applicator is held against the stratum corneum with a hold down force of at least 0.5 kg; and

delivering or sampling an agent through said microslits.

13. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum activating an impact applicator so that said microprotrusions impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less;

wherein the impact applicator is activated when the applicator is held against the stratum corneum with a hold down force of at least 0.5 kg;

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

delivering or sampling an agent through said microslits.

14. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum activating an impact applicator so that said microprotrusions impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less;

wherein the impact applicator is activated when the applicator is held against the stratum corneum with a hold down force of at least 0.5 kg;

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

delivering or sampling an agent through said microslits.

15. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum activating an impact applicator so that said microprotrusions impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less;

wherein the impact applicator is activated when the applicator is held against the stratum corneum with a hold down force of at least 0.5 kg;

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

wherein said pressure is selected from the group consisting of positive pressure, partial vacuum and a combination thereof; and

delivering or sampling an agent through said microslits.

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 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.

17. 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 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 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;

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 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 for achieving a hold down force required for device activation.

22. 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 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 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 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.

24. 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 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. 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 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 0.1 joules per cm² of microprotrusion member in 10 milliseconds or less.

26. 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 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;

wherein said applicator is activated when the applicator is pressed against the stratum corneum with a force of at least 0.5 kg.

27. 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 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 1 millisecond or less.

28. 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 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;

said microprotrusion having a length less than about 500 μ

m.

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

an agent;

an applicator having a contacting surface; 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.

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

an agent selected from the group consisting of a drug and a vaccine;

an applicator having a contacting surface; 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.

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

an agent;

an applicator having a contacting surface; 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; and

wherein said agent is coated on one or more of said microprotrusions.

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

an agent reservoir capable of collecting a body analyte;

an applicator having a contacting surface; 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.

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

a beneficial agent;

a reservoir containing said beneficial agent therein, said reservoir being capable of being placed in agent transmitting relation with the stratum corneum;

an applicator having a contacting surface; 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.

34. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less.

35. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.1 joules per cm² of the microprotrusion member in 10 milliseconds or less.

36. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 1 millisecond or less.

37. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

said microprotrusion having a length of less than 500 μ

m;

forming one or more microslits through the stratum corneum by causing said microprotrusions to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less.

38. A method of delivering or sampling an agent through the stratum corneum, comprising:

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

forming one or more microslits through the stratum corneum by causing said microblades to impact the stratum corneum with a power of at least 0.05 joules per cm² of the microprotrusion member in 10 milliseconds or less.

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.