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Microneedles, Microneedle Arrays, Methods for Making, and Transdermal and/or Intradermal Applications

  • US 20100121307A1
  • Filed: 11/02/2009
  • Published: 05/13/2010
  • Est. Priority Date: 08/24/2007
  • Status: Abandoned Application
First Claim
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1. A device for the intradermal and/or transdermal dispensing of a drug into a body of a patient through a desired delivery area, comprising:

  • a. a handleb. a cylindrical body having one or more apertures extending from an interior region to an exterior region wherein the cylindrical body and the handle are joined to one another such that relative rotation between the handle and body may occur,c. a plurality of needles extending outward from the one or more apertures, wherein the needles and cylindrical body are configured to provide a desired penetration depth into a surface of a delivery area when the cylindrical body is rolled over the delivery area as the handle is translated relative to the delivery area;

    wherein the device further includes at least one element taken from the group of elements consisting of;

    (1) at least a portion of some of the needles are formed from a multi-layer, multi-material fabrication process where each of the multiple layers are formed from the deposition of at least one structural material and at least one sacrificial material, a trimming (e.g. planarization) of the at least one structural material and the at least one sacrificial material to set a boundary level for the layer, and wherein after formation of a plurality of layers, the sacrificial material is removed from the plurality of layers;

    (2) the needles include penetration stops located proximally relative to more distal apertures in the needles such that the distance between the apertures and the penetration stops defines a desired delivery depth for the drug below surface of the delivery area;

    (3) the outer surface of the cylindrical body is covered with a membrane that inhibits flow of the drug from the needles except in those locations where the needles have been made to extend through the membrane by contact with the delivery area;

    (4) the outer surface of the cylindrical body is covered with a compressible membrane that inhibits flow of the drug from the needles except in those locations where the needles have been made to extend through the membrane by compression of the membrane against the delivery area;

    (5) the distal ends of the needles are made to extend from an interior position relative to the apertures in the cylindrical body via one or more bulges in one or more tracks along which with the needles move as the cylindrical body rotates with respect to the handle wherein the bulge or bulges correspond to a location along the perimeter of the cylindrical body that is intended to be in contact with a delivery area during a drug delivery;

    (6) a drug is held within the cylindrical body within pores of a flexible porous medium and is forced from selected needles by squeezing the porous medium adjacent the selected needles;

    (7) selected needles are extended from selected apertures via fluid pressure exerted by the drug on bases of the selected needles;

    (8) a non-rotating inter conformable structure is held with the cylindrical structure wherein the conformable structure includes a recess which acts as a reservoir for the drug and which is configured and located so that it is positioned adjacent to only a portion of the needles and in particular that portion of the needles that are located in a desired dispensing position and wherein other portions of the conformable structure act to inhibit other needles from dispensing the drug;

    (9) the distal ends of the needles are made to extend from an interior position relative to the apertures in the cylindrical body such that they extend beyond the outer surface of the cylindrical body for penetration into the tissue through the delivery area when the cylindrical body is in contact with the delivery area;

    (10) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area;

    (11) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves are made to open by a plurality of trigger mechanisms being depressed as the cylindrical body is pressed against the delivery area;

    (12) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the exit ports of the needles when trigger mechanisms are not sufficiently depressed;

    (13) a plurality of normally closed valves (i.e. when no dispensing is to occur) which can be made to open to allow fluid flow through selected needles when those needles have penetrated the tissue at the delivery area, wherein selected valves comprise valve seats that seal the fluid entry ports of the needles when trigger mechanisms are not sufficiently depressed;

    (14) the plurality of needles are held within the cylindrical body and are made to extend from the cylindrical body in a region of the cylindrical body that is in contact with the delivery area prior to dispensing the drug and after dispensing the drug are made to retract back into the cylindrical body.

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