# US 11,110,259 B2 · Microprojection applicators and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,110,259 B2 - Document ID: US11110259B2 - Status: Granted - Kind: B2 - Application number: 16/285,044 - Filed: 2019-02-25 - Published: 2019-06-20 - Granted: 2021-09-07 - Earliest claimed: 2013-03-12 - Assignees: Corium, Inc. - Applicants: Corium, Inc. - Inventors: Anthony Le; Doug Bourne; Ashutosh Shastry; Robert Wade Worsham; Parminder Singh - Web page: https://patentgrep.com/patent/US11110259B2 ## CPC - A61M 37/0015: {by using microneedles} - A61M 2005/1585: {Needle inserters} - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0046: {Solid microneedles} - A61M 2037/0061: {Methods for using microneedles} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Applicators for a microprojection array and methods of using the applicators are described. ## Claims ### Claim 1 An applicator, comprising: (a) a planar plate member with an upper surface and a lower surface, the plate member having at least one opening; (b) a planar flexure element in contact with the upper surface of the plate member, the flexure element: (i) having a gap capable of moving between first and second positions, and (ii) being positioned to align the gap with the opening in the plate member; (c) a plunger slidably disposed within the aligned gap and opening, the plunger having a shaft with a distal end on which at least one microstructure can be retained and a proximal end dimensioned such that the proximal end is retained by the gap in its first position and passes through the gap in its second position; (d) an energy-storing element positioned between the lower surface of the plate member and the distal end of the plunger; and (e) an actuating member having an external surface and a polyhedral-shaped member, the polyhedral-shaped member dimensioned to move the gap between its first and second positions when the external surface of the actuating member is contacted with sufficient force to effect release of the energy-storing element. ### Claim 2 (depends on 1) The applicator of claim 1, wherein the energy-storing element is an elastic energy element selected from a compression spring, a coil spring, and a wave spring. ### Claim 3 (depends on 1) The applicator of claim 1, wherein the proximal end of the plunger is dimensioned to be retained by the gap in its first position by a ledge at least partially circumscribing the plunger shaft. ### Claim 4 (depends on 1) The applicator of claim 1, further comprising a housing member with an opening through which the external surface of the actuating member can be received. ### Claim 5 (depends on 1) The applicator of claim 1, wherein the microstructure is a microprojection array comprising a plurality of microprojections. ### Claim 6 (depends on 5) The applicator of claim 5, wherein the plurality of microprojections includes a therapeutic agent selected from a drug, a small molecule, a protein or peptide, or a vaccine. ### Claim 7 (depends on 5) The applicator of claim 5, wherein at least a portion of the plurality of microprojections are detachable from the microprojection array. ### Claim 8 (depends on 1) The applicator of claim 1, wherein the microstructure is a microprojection array comprising a plurality of dissolvable or erodible microprojections. ### Claim 9 (depends on 1) The applicator of claim 1, wherein the polyhedral-shaped member has a gap dimensioned to receive the proximal end of the plunger. ### Claim 10 (depends on 1) The applicator of claim 1, wherein the plate opening is centrally located on the plate. ### Claim 11 (depends on 1) The applicator of claim 1, wherein at least the flexure element and the plunger are formed from a metal. ### Claim 12 (depends on 1) The applicator of claim 1, wherein the plunger shaft has a length and the energy-storing element is selected to provide a force on the plunger that causes the plunger to travel a distance longer than the length of the shaft. ### Claim 13 (depends on 1) The applicator of claim 1, further including an adhesive on at least one surface of the applicator, wherein the adhesive can secure the applicator to the skin of a subject. ### Claim 14 (depends on 1) The applicator of claim 1, further comprising a housing member with an opening through which the external surface of the actuating member can be received. ### Claim 15 (depends on 14) The applicator of claim 14, wherein the housing member includes a surface on which an adhesive is or can be applied, to secure the housing to a subject. ### Claim 16 (depends on 1) A method of delivering a therapeutic agent to a subject, comprising: (a) applying the applicator of claim 1 to a skin site of the subject, wherein the microstructure is a microprojection array comprising a therapeutic agent, the microprojection array affixed to the distal end of the plunger of the applicator; (b) contacting the external surface of the actuating member to actuate the actuator from a first position to a second position, whereby the flexure element gap is moved from its first position to its second position, thereby releasing the plunger from a restrained position to a deployed position in contact with the subject's skin; and (c) delivering the therapeutic agent from the microprojection array to the subject. ### Claim 17 (depends on 16) The method of claim 16, wherein step (a) further comprises adhering the applicator to the subject's skin. ### Claim 18 (depends on 16) The method of claim 16, wherein the microprojection array comprises a plurality of microprojections. ### Claim 19 (depends on 16) The method of claim 16, wherein the microprojection array comprises a plurality of dissolvable or erodible microprojections. ### Claim 20 (depends on 16) The method of claim 16, wherein the microprojection array comprises a plurality of microprojections, where in the deployed position, the plunger has an equilibrium position such that the distal end of the plunger on which at least a portion of the plurality of microprojections are positioned below the surface of the skin. ### Claim 21 (depends on 20) The method of claim 20, wherein the equilibrium position is about 0.03-0.2 inches below the surface of the skin of the subject.