Devices and methods for enhanced microneedle penetration of biological barriers

a technology of enhanced microneedle and biological barrier, which is applied in the field of devices and methods for enhanced microneedle penetration of biological barrier, can solve the problems of drug not being effectively delivered in this manner, drug not being effectively diffused across the intestinal mucosa, and patient compliance may also be a problem, so as to improve interaction, enhance the transport of molecules, and limit the effect of elasticity

Inactive Publication Date: 2005-06-23
VALERITAS LLC (US) +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014] Microneedle devices and methods of use thereof are provided for the enhanced transport of molecules, including drugs and biological molecules, across tissue by improving the interaction of an array of microneedles and a deformable, elastic biological barrier, such as human skin. The devices and...

Problems solved by technology

However, a frequent limitation of these drugs is their delivery: how to transport drugs across biological barriers in the body (e.g., the skin, the oral mucosa, the blood-brain barrier), which normally do not transport drugs at rates that are therapeutically useful or optimal.
However, many drugs cannot be effectively delivered in this manner, due to degradation in the gastrointestinal tract and/or elimination by the liver.
Moreover, some drugs cannot effectively diffuse across the intestinal mucosa.
Patient compliance may also be a problem, for example, in therapies requiring that pills be taken at particular intervals over a prolonged time.
While effective for this purpose, needles generally cause pain; local damage to the skin at the site of insertion; bleeding, which increases the risk of disease transmission; and a wound sufficiently large to be a site of infection.
The needle technique also is undesirable for long term, controlled continuous drug delivery.
Similarly, current methods of sampling biological fluids are invasive and suffer from the same disadvant...

Method used

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  • Devices and methods for enhanced microneedle penetration of biological barriers
  • Devices and methods for enhanced microneedle penetration of biological barriers
  • Devices and methods for enhanced microneedle penetration of biological barriers

Examples

Experimental program
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Effect test

example 1

Fabrication of Solid Silicon Microneedles

[0198] A chromium masking material was deposited onto silicon wafers and patterned into dots having a diameter approximately equal to the base of the desired microneedles. The wafers were then loaded into a reactive ion etcher and subjected to a carefully controlled plasma based on fluorine / oxygen chemistries to etch very deep, high aspect ratio valleys into the silicon. Those regions protected by the metal mask remain and form the microneedles.

[0199]-oriented, prime grade, 450-550 μm thick, 10-15 Ω-cm silicon wafers (Nova Electronic Materials Inc., Richardson, Tex.) were used as the starting material. The wafers were cleaned in a solution of 5 parts by volume deionized water, 1 part 30% hydrogen peroxide, and 1 part 30% ammonium hydroxide (J. T. Baker, Phillipsburg, N.J.) at approximately 80° C. for 15 minutes, and then dried in an oven (Blue M Electric, Watertown, Wis.) at 150° C. for 10 minutes. Approximately 1000 Å of chromium (Mat-Vac ...

example 2

Transdermal Transport Using Solid Microneedles

[0202] To determine if microfabricated microneedles could be used to enhance transdermal drug delivery, arrays of microneedles were made using a deep plasma etching technique. Their ability to penetrate human skin without breaking was tested and the resulting changes in transdermal transport were measured.

[0203] Arrays of microneedles were fabricated having extremely sharp tips (radius of curvature less than 1 μm), and are approximately 150 μm long. Because the skin surface is not flat due to dermatoglyphics and hair, the full length of these microneedles will not penetrate the skin. All experiments were performed at room temperature (23±2° C.).

[0204] The ability of the microneedles to pierce skin without breaking was then tested. Insertion of the arrays into skin required only gentle pushing. Inspection by light and electron microscopy showed that more than 95% of microneedles within an array pierced across the stratum corneum of the...

example 3

Fabrication of Silicon Microtubes

[0208] Three-dimensional arrays of microtubes were fabricated from silicon, using deep reactive ion etching combined with a modified black silicon process in a conventional reactive ion etcher. The fabrication process is illustrated in FIGS. 4a-d. First, arrays of 40 μm diameter circular holes 32 were patterned through photoresist 34 into a 1 μm thick SiO2 layer 36 on a two inch silicon wafer 38 (FIG. 4a). The wafer 38 was then etched using deep reactive ion etching (DRIE) (Laermer, et al., “Bosch Deep Silicon Etching: Improving Uniformity and Etch Rate for Advanced MEMS Applications,”Micro Electro Mechanical Systems, Orlando, Fla., USA (Jan. 17-21, 1999)). in an inductively coupled plasma (ICP) reactor to etch deep vertical holes 40. The deep silicon etch was stopped after the holes 40 are approximately 200 μm deep into the silicon substrate 38 (FIG. 4b) and the photoresist 34 was removed. A second photolithography step patterned the remaining SiO2...

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PUM

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Abstract

Microneedle devices and methods of use thereof are provided for the enhanced transport of molecules, including drugs and biological molecules, across tissue by improving the interaction of microneedles and a deformable, elastic biological barrier, such as human skin. The devices and methods act to (1) limit the elasticity, (2) adapt to the elasticity, (3) utilize alternate ways of creating the holes for the microneedles to penetrate the biological barrier, other than the simply direct pressure of the microneedle substrate to the barrier surface, or (4) any combination of these methods. In preferred embodiments for limiting the elasticity of skin, the microneedle device includes features suitable for stretching, pulling, or pinching the skin to present a more rigid, less deformable, surface in the area to which the microneedles are applied (i.e. penetrate). In a preferred embodiments for adapting the device to the elasticity of skin, the device comprising one or more extensions interposed between the substrate and the base end of at least a portion of the microneedles.

Description

BACKGROUND OF THE INVENTION [0001] This invention is generally in the field of devices for the transport of therapeutic or biological molecules across tissue barriers, such as for drug delivery or sampling of biological fluids. [0002] Numerous drugs and therapeutic agents have been developed in the battle against disease and illness. However, a frequent limitation of these drugs is their delivery: how to transport drugs across biological barriers in the body (e.g., the skin, the oral mucosa, the blood-brain barrier), which normally do not transport drugs at rates that are therapeutically useful or optimal. [0003] Drugs are commonly administered orally as pills or capsules. However, many drugs cannot be effectively delivered in this manner, due to degradation in the gastrointestinal tract and / or elimination by the liver. Moreover, some drugs cannot effectively diffuse across the intestinal mucosa. Patient compliance may also be a problem, for example, in therapies requiring that pill...

Claims

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Application Information

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IPC IPC(8): A61B5/00A61B5/15A61B17/20A61M5/42A61M37/00
CPCA61B5/1411A61B5/14514A61B5/14532A61B17/205A61M2037/0053A61M5/425A61M37/0015A61M2037/0023A61M2037/003A61M5/422A61B5/150022A61B5/150068A61B5/150076A61B5/150083A61B5/150099A61B5/150213A61B5/150229A61B5/150389A61B5/150412A61B5/150503A61B5/150984A61B5/151B33Y80/00
Inventor PRAUSNITZ, MARK R.ALLEN, MARK G.HENRY, SEBASTIANMCALLISTER, DEVIN V.ACKLEY, DONALD E.JACKSON, THOMAS
Owner VALERITAS LLC (US)
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