US 12,138,416 B2
Drug delivery devices having separable microneedles and methods
Devin V. McAllister, Marietta, GA (US); Mark R. Prausnitz, Atlanta, GA (US); and Sebastien Henry, Smyrna, GA (US)
Assigned to Georgia Tech Research Corporation, Atlanta, GA (US)
Filed by Georgia Tech Research Corporation, Atlanta, GA (US)
Filed on Feb. 24, 2021, as Appl. No. 17/184,140.
Application 17/184,140 is a division of application No. 15/566,748, granted, now 10,940,301, previously published as PCT/US2016/028164, filed on Apr. 18, 2016.
Claims priority of provisional application 62/149,043, filed on Apr. 17, 2015.
Prior Publication US 2021/0196937 A1, Jul. 1, 2021
Int. Cl. A61M 37/00 (2006.01)
CPC A61M 37/0015 (2013.01) [A61M 2037/0007 (2013.01); A61M 2037/0023 (2013.01); A61M 2037/0046 (2013.01); A61M 2037/0061 (2013.01)] 28 Claims
OG exemplary drawing
 
1. A drug delivery device for administering a drug into a skin tissue, the device comprising:
an array of microneedles which comprise a drug and which extend from a base;
a system configured to trigger, after the microneedles are inserted at least partially into a skin tissue, a change in rate of release of the drug from the microneedles and into the skin tissue; and
means for separating tip portions of the microneedles from proximal end portions of the microneedles extending from the base following insertion of the microneedles into the skin tissue, wherein the separation occurs, at an interface of two distinct materials, upon application of a force to the base sufficient to at least partially penetrate the skin tissue with the array of microneedles.
 
6. A drug delivery device comprising:
a substrate having a microneedle side and an opposing back side;
an array of microneedles extending from the microneedle side of the substrate, wherein the microneedles comprise a drug;
a supporting layer arranged on the opposing back side of the substrate; and
wherein the microneedles are coated with a barrier so that upon separation of the microneedles following insertion into a tissue surface, the drug is released only from an end portion of the microneedles where the separation occurred.
 
9. A drug delivery device comprising:
a substrate having a microneedle side and an opposing back side; and
an array of microneedles extending from the microneedle side of the substrate,
wherein the microneedles are formed by a molding process which comprises at least two castings, whereby each of the microneedles comprises (i) a tip portion comprising a first material which comprises a drug, and (ii) a proximal end portion comprising a second material, wherein the first and second materials are different in composition form one another and have an interface forming a predefined region configured to effect separation of the tip portion from the proximal end portion upon application of a force to the substrate sufficient to at least partially penetrate into a patient's skin with the array of microneedle.
 
23. A drug delivery device comprising:
an array of microneedles extending from a base substrate,
wherein the microneedles each comprise a tip portion comprising a first material in which a drug is dispersed, and a proximal end portion comprising a second material which is different in composition from the first material,
wherein the first and second materials have an interface configured to effect separation of the tip portions from the proximal end portions, wherein the separation of the tip portions from the proximal end portions occurs upon application of an input force applied by a user to the drug delivery device to at least partially penetrate a patient's skin with the microneedles.