# US 6,083,196 A · Device for enhancing transdermal agent flux > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 6,083,196 A - Document ID: US6083196A - Status: Granted - Kind: A - Application number: 09/208,812 - Filed: 1998-12-09 - Granted: 2000-07-04 - Earliest claimed: 1998-12-09 - Assignees: Alza Corporation - Inventors: Joseph Creagan Trautman; Michel J. N. Cormier; Hyunok Lynn Kim; Michael G. Zuck - Web page: https://patentgrep.com/patent/US6083196A ## CPC - A61M 37/0015: {by using microneedles} - A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction} - A61B 17/205: {Vaccinating by means of needles or other puncturing devices} - A61N 1/303: {Constructional details (electrodes for external use A61N1/0428)} - A61M 2037/0007: {having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents} - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0046: {Solid microneedles} - A61M 2037/0053: {Methods for producing microneedles} - A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body} - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A device (3) comprising a sheet member (6) having a plurality of microprotrusions (4) for penetrating the skin and a substantially incompressible agent reservoir housing (15) contacting and extending across the sheet member (6) for transmitting a hold-down force applied the sheet member (6) to maintain the microprotrusions (4) in skin-piercing relation to the skin, even during and after normal patient body movement. ## Claims ### Claim 1 A device for use in introducing or withdrawing an agent through a body surface, comprising: a body surface piercing member having a plurality of microprotrusions extending from a body surface proximal portion of the member, the microprotrusions being adapted to pierce the body surface to a depth of up to about 500 .mu.m, a housing containing a reservoir for the agent to be introduced or withdrawn, the housing contacting and extending across a substantial portion of a body surface distal portion of the piercing member and maintaining the reservoir in agent-transmitting relation with the pierced body surface, the housing having a compressibility, in a direction normal to the body surface, of less than about 250 .mu.m, and a securing member for securing the device to the body surface. ### Claim 2 (depends on 1) The device of claim 1, wherein the housing contacts and extends across the entire body distal portion of the piercing member. ### Claim 3 (depends on 1) The device of claim 1, wherein the securing member is selected from the group consisting of an adhesive overlay, a tape and a strap. ### Claim 4 (depends on 1) The device of claim 1, wherein the housing has a compressibilty of less than about 50 .mu.m. ### Claim 5 (depends on 1) The device of claim 1, wherein the housing is comprised of a material selected from the group consisting of porous sintered polymers, open cell polymeric foams, porous polymer sheets, polymer screens, woven polymeric fabrics, porous ceramics, and a corrugated polymer sheet. ### Claim 6 (depends on 1) The device of claim 1, wherein the housing has sufficient flexibility to form a curved configuration in response to a hold down force applied by the securing member. ### Claim 7 (depends on 6) The device of claim 6, wherein the housing is comprised of a material selected from the group consisting of porous sintered polymers, open cell polymeric foams, porous polymer sheets, polymer screens, woven polymeric fabrics and a corrugated polymer sheet. ### Claim 8 (depends on 3) The device of claim 3, wherein the securing member comprises an adhesive. ### Claim 9 (depends on 8) The device of claim 8, wherein the adhesive is a skin contact adhesive. ### Claim 10 (depends on 1) The device of claim 1, wherein the housing is comprised of a plurality of sections, each section being substantially non-flexible in response to a hold down force applied by the securing means, the sections being hingedly attached to one another. ### Claim 11 (depends on 1) The device of claim 1, wherein the housing is comprised of porous sintered high density polyethylene. ### Claim 12 (depends on 1) The device of claim 1, wherein the housing is comprised of open cell polyurethane foam. ### Claim 13 (depends on 1) The device of claim 1, wherein the housing is comprised of open cell polyvinyl alcohol foam. ### Claim 14 (depends on 1) The device of claim 1, wherein the agent is a drug to be introduced into the body surface and the reservoir is a drug reservoir. ### Claim 15 (depends on 14) The device of claim 14, wherein the drug reservoir contains a transdermal drug formulation. ### Claim 16 (depends on 1) The device of claim 1, wherein the agent is a body analyte to be withdrawn from the body surface and the reservoir is an analyte collection reservoir. ### Claim 17 (depends on 16) The device of claim 16, wherein the body analyte is glucose. ### Claim 18 (depends on 1) The device of claim 1, wherein the piercing member comprises a sheet having a thickness of about 5 to 100 .mu.m, the sheet having a plurality of openings therethrough, a body proximal surface adapted to be placed against the body surface and said plurality of microprotrusions extending from the body proximal surface. ### Claim 19 (depends on 18) The device of claim 18, wherein the sheet is comprised of metal. ### Claim 20 (depends on 19) The device of claim 19 wherein the metal is selected from the group consisting of stainless steel and titanium. ### Claim 21 (depends on 1) The device of claim 1, wherein the piercing member comprises a sheet having a thickness of about 5 to 100 .mu.m, the sheet having a body proximal edge, with said plurality of microprotrusions, adapted to be placed against said body surface. ### Claim 22 (depends on 21) The device of claim 21, wherein the sheet is comprised of metal. ### Claim 23 (depends on 22) The device of claim 22, wherein the metal is selected from the group consisting of stainless steel and titanium. ### Claim 24 (depends on 21) The device of claim 21, wherein the housing comprises a plurality of said sheets. ### Claim 25 (depends on 1) The device of claim 1, wherein the microprotrusions are maintained in piercing relation to the skin surface of an animal during normal movement thereof. ### Claim 26 (depends on 1) The device of claim 1, wherein the housing has a honeycomb structure. ### Claim 27 (depends on 1) The device of claim 1, wherein the housing has a peripheral wall and at least one cross member. ### Claim 28 (depends on 27) The device of claim 27, wherein the housing has a plurality of cross members. ### Claim 29 (depends on 28) The device of claim 28, wherein adjacent cross members are separated by a distance of no more than about 4 times a distance separating adjacent microprojections on the piercing member.