초록 ▼

Microneedle arrays and drug delivery devices are provided for transdermally delivering a drug formulation to a patient. The microneedle array device includes a substantially planar substrate having an array of apertures; and a plurality of microneedles projecting at angle from the planar substrate,

Microneedle arrays and drug delivery devices are provided for transdermally delivering a drug formulation to a patient. The microneedle array device includes a substantially planar substrate having an array of apertures; and a plurality of microneedles projecting at angle from the planar substrate, the microneedles having a base portion integrally connected to the substrate, a tip end portion distal to the base portion, and body portion therebetween, wherein each microneedle has at least one channel extending substantially from the base portion through at least a part of the body portion, the channel being open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate. In a preferred embodiment, each microneedle has a substantially rectangular cross-sectional shape and the channel is open to two opposing surfaces of the microneedle.

대표청구항 ▼

I claim: 1. A microneedle array for insertion into a biological tissue and delivering a fluid through a biological barrier comprising: a substantially planar substrate having an array of spaced apertures therein; and a plurality of microneedles projecting at angle from the plane in which the planar

I claim: 1. A microneedle array for insertion into a biological tissue and delivering a fluid through a biological barrier comprising: a substantially planar substrate having an array of spaced apertures therein; and a plurality of microneedles projecting at angle from the plane in which the planar substrate lies, the microneedles having a base portion integrally connected to the substrate, a tapered tip end portion distal to the base portion, and a rectangular body portion therebetween, wherein at least one of the microneedles has at least one elongated channel, which has a substantially rectangular middle portion, the channel extending through 50% to 99% of the length and about one-third of the width of the at least one microneedle substantially from the planar substrate, through the base portion, and through at least a part of the body portion, and wherein the channel (i) is open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate, and (ii) forms an opening extending through the substrate, thereby providing an unrestricted fluid conduit between the tapered tip end portion of the microneedle and the surface of the substrate distal to the microneedle. 2. The microneedle array of claim 1, wherein the at least one of the microneedles has a substantially rectangular cross-sectional shape in a plane parallel to the substrate. 3. The microneedle array of claim 2, wherein the at least one channel is open to two opposing surfaces of the microneedle. 4. The microneedle array of claim 1, wherein the at least one channel terminates in the body portion of the microneedle and does not extend into the tapered tip portion. 5. The microneedle array of claim 1, wherein the substrate and the microneedles comprise at least one biocompatible metal. 6. The microneedle array of claim 1, wherein the substrate and the microneedles comprise a stainless steel. 7. The microneedle array of claim 1, wherein the substrate and microneedles comprise at least one biocompatible polymer. 8. The microneedle array of claim 1, wherein the length of the at least one microneedle is between 10 μm and 1000 μm. 9. The microneedle array of claim 8, wherein the length of the at least one microneedle is between 100 μm and 500 μm. 10. The microneedle array of claim 1, wherein the at least one microneedle has a maximum width dimension of 500 μm. 11. The microneedle array of claim 1, wherein the body portion of the at least one microneedle has a single, centrally located channel extending through the opposed longer sides of the body portion. 12. The microneedle array of claim 1, wherein the rectangular body portion has a long side cross-sectional dimension between 1 μm and 500 μm and a short side cross-sectional dimension between 1 μm and 200 μm. 13. The microneedle array of claim 1, wherein the apertures in the substrate are polygonal in shape, each aperture being defined by three or more interior side surfaces in the substrate. 14. The microneedle array of claim 13, wherein the base portion of the at least one microneedle includes a curved portion that extends from at least one of the interior side surfaces of the substrate. 15. The microneedle array of claim 14, wherein a proximal end of the at least one channel extends to or into the at least one of the interior side surfaces of the substrate. 16. The microneedle array of claim 1, wherein the at least one elongated channel is dimensioned to provide a capillary effect to wick the fluid into the base portion of said microneedle from the substrate aperture, through the body portion of said microneedle, and toward the tip portion of said microneedle. 17. A device for insertion into a biological tissue for transdermal administration of a fluid drug formulation, comprising: a substantially planar substrate having an array of spaced apertures therein; a plurality of microneedles projecting at angle from the plane in which the planar substrate lies, the microneedles having a base portion integrally connected to the substrate, a tapered tip end portion distal to the base portion, and a rectangular body portion therebetween, wherein at least one of the microneedles has at least one elongated channel, which has a substantially rectangular middle portion, the channel extending through 50% to 99% of the length and about one-third of the width of the at least one microneedle, substantially from the planar substrate through the base portion, and through at least a part of the body portion; and at least one drug storage element, which contains the fluid drug formulation, positioned adjacent to the planar substrate, wherein the channel (i) is open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate, and (ii) forms an opening extending through the substrate, thereby providing in operation an unrestricted fluid conduit between the tapered end portion of the microneedle and the at least one drug storage element. 18. The device of claim 17, wherein the at least one of the microneedles has a substantially rectangular cross-sectional shape in a plane parallel to the substrate. 19. The device of claim 18, wherein the at least one channel is open to two opposing surfaces of the microneedle. 20. The device of claim 17, wherein the drug storage element is attached to a first surface of the planar substrate, said first surface being opposed to a second surface of the planar substrate of the microneedle array, wherein the microneedles project from said second surface. 21. The device of claim 17, further comprising a release mechanism for releasing the drug formulation from the drug storage element to permit the drug formulation to pass into and through the at least one channel of the at least one microneedle. 22. The device of claim 21, wherein the release mechanism utilizes a mechanical force, heat, a chemical reaction, an electric field, a magnetic field, a pressure field, ultrasonic energy, vacuum, pressure, or a combination thereof. 23. The device of claim 17, wherein the drug storage element comprises a porous material, wherein the drug formulation is stored in pores of the porous material. 24. The device of claim 17, wherein the drug storage element comprises at least one sealed reservoir. 25. The device of claim 24, further comprising at least one puncturing barb extending from the first surface of the planar substrate, wherein the puncturing barb can be used to puncture the sealed reservoir. 26. The device of claim 17, further comprising a backing structure and adhesive surface suitable for securing the device to the skin of a patient during administration of the drug formulation to the patient. 27. A method of administering a drug to a patient in need thereof, comprising: inserting into the skin of the patient the microneedles of the device of claim 17, and causing the drug formulation to be transported from the drug storage element into and through the at least one channel of the microneedle and through the stratum corneum of the skin. 28. The method of claim 27, wherein the transport of the drug formulation is driven or assisted by capillary force, gravitational force, overpressure, vacuum, an electric field, a magnetic field, iontophoresis, a molecular concentration gradient, or a combination thereof. 29. A device for insertion into a biological tissue for transdermal administration of a fluid, comprising: a substantially planar substrate having an array of spaced apertures therein; a plurality of microneedles projecting at angle from the plane in which the planar substrate lies, the microneedles having a base portion integrally connected to the substrate, a tapered tip end portion distal to the base portion, and a rectangular body portion therebetween; and at least one fluid storage element, which contains a fluid, positioned adjacent to the planar substrate, wherein at least one of the microneedles has an elongated channel, which has a substantially rectangular middle portion and is in fluid communication with at least one of the apertures in the substrate, the elongated channel being open to two opposing surfaces of the microneedle and extending through 50% to 99% of the length and about one-third of the width of the microneedle, to provide a fluid conduit between the tapered end portion of the microneedle and the at least one fluid storage element.