Microneedle devices and methods of manufacture and use thereof
Patent 6334856 Issued on January 1, 2002. Estimated Expiration Date: May 21, 2019. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
604/191, Having plural material reservoirs128/898, Methods216/75, Substrate contains elemental metal, alloy thereof, or metal compound604/272Body piercing condit (e.g., needle, etc.)
Microneedle devices are provided for transport of therapeutic and biological molecules across tissue barriers and for use as microflameholders. In a preferred embodiment for transport across tissue, the microneedles are formed of a biodegradable polymer. Methods of making these devices, which can include hollow and/or porous microneedles, are also provided. A preferred method for making a microneedle includes forming a micromold having sidewalls which define the outer surface of the microneedle, electroplating the sidewalls to form the hollow microneedle, and then removing the micromold from the microneedle. In a preferred method of use, the microneedle device is used to deliver fluid material into or across a biological barrier from one or more chambers in fluid connection with at least one of the microneedles. The device preferably further includes a means for controlling the flow of material through the microneedles. Representative examples of these means include the use of permeable membranes, fracturable impermeable membranes, valves, and pumps.
Other References
"Single-crystal whiskers," Biophotonics Int'l p. 64 (Nov./Dec. 1996)
"101 Uses for Tiny Tubules," Science 247 (1990)
Amsden, et al., "Transdermal Delivery of Peptide and Protein Drugs: an Overview," AIChE Journal 41(8):1972-1997 (1995)
*Bronaugh & Maibach, Percutaneous Absorption, Mechanisms--Methodology--Drug Delivery (Marcel Dekker, New York 1989)
Brumlik, et al., "Template Synthesis of Metal Microtubules," J. Am. Chem. Soc. 113:3174-3175 (1991)
*Despont, et al., "High-Aspect-Ratio, Ultrathick, Negative-Tone Near-UV Photoresist for MEMS," Proc. of IEEE 10th Annual International Workshop on MEMS, Nagoya, Japan, pp. 518-522 (Jan. 26-30, 1997)
Edell, et al., "Factors Influencing the Biocompatibility of Insertable Silicon Microshafts in Cerebral Cortex," IEEE Transactions on Biomedical Engineering 39(6):635-43 (1992)
Frazier, et al., "Two dimensional metallic microelectrode arrays for extracellular stimulation and recording of neurons", IEEE Proceedings on the Micro Electro Mechanical Systems Conference, pp. 195-200 (1993)
Frazier, et al., "Metallic Microstructures Fabricated Using Photosensitive Polyimide Electroplanting Molds," Journal of Microelectromechanical Systems 2:87-97 (1993)
*Hadgraft & Guy, eds., Transdermal Drug Delivery: Developmental Issues and Research Initiatives (Marcel Dekker New York 1989)
Haga, et al., "Transdermal iontophoretic delivery of insulin using a photoetched microdevice," J. Controlled Release 43:139-49 (1997)
Hashmi, et al., "Genetic Transformation of Nematodes Using Arrays of Micromechanical Piercing Structures," Bio Techniques 19(5):766-70 (1995)
*Henry, et al., "Micromachined Needles for the Transdermal Delivery of Drugs," Micro Electro Mechanical Systems, Heidelberg, Germany, pp. 494-498 (Jan. 26-29, 1998)
*Henry, et al., "Microfabricated microneedles: A novel method to increase transdermal drug delivery," J. Pharm. Sci. 87:922-925 (1998)
*Hoffert, "Transcutaneous methods get under the skin," The Scientist 12 (1998)
*Jaeger, Introduction to Microelectronic Fabrication (Addison-Wesley Publishing Co., Reading MA 1988)
Jansen, et al., "The Black Silicon Method IV: The Fabrication of Three-Dimensional Structures in Silicon with High Aspect Ratios for Scanning Probe Microscopy and Other Applications," IEEE Proceedings of Micro Electro Mechanical Systems Conference, pp. 88-93 (1995)
*Laermer, et al., "Bosch Deep Silicon Etching: Improving Uniformity and Etch Rate for Advanced MEMS Applications," Micro Electro Mechanical Systems, Orlando, Fl, USA, (Jan. 17-21, 1999).
Langer, "Drug Delivery and Targeting," Nature 392:5-10 (1998)
Lehmann, "Porous Silicon--A New Material for MEMS", IEEE Proceedings of the Micro Electro Mechanical Systems Conference, pp. 1-6 (1996)
Lin, et al., "Silicon Processed Microneedles," The 7th International Conference on Solid-State Sensors and Actuators 237-240 (1993)
Martin, et al., "Template Synthesis of Organic Microtubules," J. Am. Chem. Soc. 112:8976-8977 (1990)
Najafi, et al., "Strength Characterization of Silicon Microprobes in Neurophysiological Tissues," IEEE Transcriptions on Biomedical Engineering 37(5): 474-481 (1990)
Prausnitz, "Reversible Skin Permeabilization for Transdermal Delivery of Macromolecules," Critical Reviews in Therapeutic Drug Carrier Systems 37(5): 474-481 (1990)
*Proceedings of the IEEE MIcro Electro Mechanical Systems Conference 1987-1998; Rai-Choudhury, ed., Handbook of Microlithography, Micromaching & Microfabrication (SPIE Optical Engineering Press, Bellingham, WA 1997)
*Schift, et al., "Fabrication of replicated high precision insert elements for micro-optical bench arrangements" Proc. SPIE--International Soc. Optical Engineer 3513:122-134 (1998)
Talbot, et al., "Polymolding: Two Wafer Polysilicon Micromoding of Closed-Flow Passages for Microneedles and Microfluidic Devices," Solid-State Sensor and Actuator Workshop Hilton Head Island, South Carolina, Jun. 8-11 266-268 (1988)
Trimmer, et al., "Injection of DNA into Plant and Animal Tissues with Micromechanical Piercing Structures," IEEE Proceedings of Micro Electro Mechanical Systems Conference, pp. 111-15 (1995)
*Weber, et al., "Micromolding--a powerful tool for the large scale production of precise microstructures," Proc. SPIE--International Soc. Optical Engineer 2879:156-167 (1996)
Zuska, "Microtechnology Opens Doors to the Universe of Small Space," Medical Device and Diagnostic Industry, p. 131 (1997