Device for enhancing transdermal agent delivery or sampling

• US 6,230,051 B1
• Filed: 06/17/1997
• Issued: 05/08/2001
• Est. Priority Date: 06/18/1996
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cormier, Michel J. N., Block, Barry, Nat, Avtar S., Neukermans, Armand P.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/877,153
• Time in Patent Office: 1,421 Days
• Field of Search: 604/20, 604/46, 604/47, 604/239, 604/264, 604/272-274, 607/149, 600/573, 600/575, 600/576, 600/345, 600/309, 600/347, 600/365, 600/373
• US Class Current: 604/20
• 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 the skin for increasing transdermal flux of an agent. The microblades having a relatively sharp angled leading edge which transitions to a relatively gradually angled blade edge.

Claims

1. A device for treating the stratum corneum of a body surface comprising:

a sheet having at least one opening therethrough and a plurality of microblades folded downward from the sheet, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, wherein the width of the microblade at the intersection of the microblade and the sheet is in the range of about 10 microns to about 500 microns and the thickness of the microblade is in the range of about 7 microns to about 100 microns.

2. The device of claim 1, wherein the first angle is in the range of about 1°

to 25° and

the angle of the second angled segment is in the range of about 26°

to 80°

.

3. The device of claim 1, wherein the first angle is about 15°

and the angle of the second angled segment is about 30°

.

4. The device of claim 1, wherein the first angle is about 15°

and the angle of the second angled segment is about 35°

.

5. The device of claim 1, further comprising a third angled segment contiguous with the second angled segment and having an angle relative to the axis greater than the angle of the second angled segment.

6. The device of claim 1, further comprising a plurality of contiguous angled segments wherein each of the subsequent angled segments progressing proximally along the microblade from the second angled seqment have an angle relative to the axis greater than the angle of the preceding angled segment.

7. The device of claim 1, wherein the first and second angled segments are part of an arc-shaped microblade tip.

8. The device of claim 1, further comprising a therapeutic agent delivery device connected to the treating device and positioned to deliver a therapeutic agent through the opening to the body surface.

9. The device of claim 1, further comprising a sampling device connected to the treating device and positioned to sample a substance from the body surface through the opening.

10. The device of claim 1, wherein the microblades are configured to form pathways in the stratum corneum through which a substance can be introduced or withdrawn.

11. The device of claim 1, wherein at least a portion of the microblade separates the second angled portion from the sheet.

12. The device of claim 1 wherein the length of the microblades is less than about 500 micrometers.

22. The device of claim 10, wherein the length of the microblades is less than about 500 micrometers.

13. A device for treating the stratum corneum of a body surface comprising:

a sheet having at least one opening therethrough and a plurality of microblades located along a periphery thereof and extending downward from the sheet, at least a portion of the plurality of microblades having first angled segments located distally on each side of an axis along the length of the microblade, each of the first segments having a first angle relative to the axis, and contiguous with the first segments, second segments on each side of the axis each having an angle relative to the axis greater than the first angle, wherein the width of the microblade at the intersection of the microblade and the sheet is in the range of about 10 microns to about 500 microns and the thickness of the microblade is in the range of about 7 microns to about 100 microns.

14. The device of claim 13, wherein the first angle of each of the first segments is in the range of about 1°

to 25° and

the angle of each of the second angled segments is in the range of about 26°

to 80°

.

15. The device of claim 13, wherein the first angle of each of the first segments is about 15°

and the angle of each of the second segments is about 30°

.

16. The device of claim 13, wherein the first angle of each of the first segments are not equal angles.

17. The device of claim 13, wherein the angle of each of the second segments are not equal angles.

18. The device of claim 13, further comprising a therapeutic agent delivery device connected to the treating device and positioned to deliver a therapeutic agent through the opening to the body surface.

19. The device of claim 13, further comprising a sampling device connected to the treating device and positioned to sample a substance from the body surface through the openings.

20. The device of claim 13, wherein the microblades are configured to form pathways in the stratum corneum through which a substance can be introduced or withdrawn.

21. The device of claim 13, wherein at least a portion of the microblade separates the second angled portion from the sheet.

23. 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 at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first angle is about 15° and

the angle of the second angled segment is about 30°

.

27. The device of claims 23, 24, 25 or 26, wherein the length of the microblades is less than about 500 micrometers.

24. 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 at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first angle is about 15° and

the angle of the second angled segment is about 35°

.

25. 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 at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle; and

a plurality of contiguous angled segments wherein each of the subsequent angled segments progressing proximally along the microblade from the second angled segment have an angle relative to the axis greater than the angle of the preceding angled segment.

26. 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 at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first and second angled segments are part of an arc-shaped microblade tip.