# US 6,322,808 B1 · Device for enhancing transdermal agent flux

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- Number: US 6,322,808 B1
- Document ID: US6322808B1
- Status: Granted
- Kind: B1
- Application number: 09/208,813
- Filed: 1998-12-09
- Granted: 2001-11-27
- Earliest claimed: 1998-12-09
- Assignees: Alza Corporation
- Inventors: Joseph Creagan Trautman; Patrick S.-L. Wong; Peter E. Daddona; Hyunok Lynn Kim; Michael G. Zuck
- Web page: https://patentgrep.com/patent/US6322808B1

## CPC

- A61M 37/0015: {by using microneedles}
- A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction}
- A61K 9/0021: {Intradermal administration, e.g. through microneedle arrays or needleless injectors}
- A61B 2010/008: {Interstitial fluid}
- 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 2037/003: {having a lumen}
- A61M 2037/0038: {having a channel at the side surface}
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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 rigid support (15) contacting and extending across the sheet member (6) for transmitting an applied force evenly across the length and width of the sheet member (6) to reproducibly and reliably penetrate the skin with the microprotrusions (4).

## Claims

### Claim 1

A device for use in introducing or withdrawing an agent through a body surface, comprising:
a thin, flexible sheet-like member having a plurality of microprotrusions extending from a body surface proximal portion of the member; and
a structural support which defines one or more voids for an agent-containing or agent receiving reservoir and which extends substantially across, and makes contact substantially across, a width, length and/or diameter of the member, the support having greater rigidity than the member and wherein the structural support substantially reduces the tendency of the member to deflect upon application of a force to the top of the structural support.

### Claim 2 (depends on 1)

The device of claim 1, wherein the support has greater rigidity to a force applied perpendicular to the body surface than does the member.

### Claim 3 (depends on 1)

The device of claim 1, wherein the support is sufficiently rigid to deflect less than 300 μm under manually applied finger or hand pressing of the device against skin.

### Claim 4 (depends on 3)

The device of claim 3, wherein the support deflects less than 50 μm under said pressing.

### Claim 5 (depends on 1)

The device of claim 1, wherein the support is sufficiently incompressible to compress less than 250 μm under manually applied finger or hand pressing of the device against skin.

### Claim 6 (depends on 5)

The device of claim 5, wherein the support compresses less than 50 μm under said pressing.

### Claim 7 (depends on 1)

The device of claim 1, wherein the member comprises a sheet which in use is oriented approximately parallel to the body surface, the sheet having a plurality of openings therein and the plurality of microprotrusions extending from a body proximal surface of the sheet, said microprotrusions being adapted to pierce the body surface.

### Claim 8 (depends on 1)

The device of claim 1, wherein the structural support comprises a plurality of cross-members, the cross-members being spaced no more than about 4 times a distance between adjacent microprotrusions in said microprotrusion member.

### Claim 9 (depends on 7)

The device of claim 7, wherein the reservoir is in agent-transmitting communication with the openings in the sheet.

### Claim 10 (depends on 1)

The device of claim 1, wherein the support comprises a peripheral member and a plurality of cross-members.

### Claim 11 (depends on 1)

The device of claim 1, wherein the support has a honeycomb structure.

### Claim 12 (depends on 1)

The device of claim 1, wherein the support comprises a corrugated sheet.

### Claim 13 (depends on 1)

The device of claim 1, wherein the support has a curved surface which contacts the member.

### Claim 14 (depends on 13)

The device of claim 13, wherein the curved surface has a shape selected from the group consisting of convex and cylindrical.

### Claim 15 (depends on 7)

The device of claim 7, wherein the support comprises a plurality of wavy strips arranged in perpendicular alignment to the sheet.

### Claim 16 (depends on 1)

The device of claim 1, wherein the member has a thickness of less than 100 μm.

### Claim 17 (depends on 16)

The device of claim 16, wherein the member is comprised of metal.

### Claim 18 (depends on 1)

The device of claim 1, wherein the member comprises a sheet having the plurality of microprotrusions extending from a body surface proximal edge of the sheet for piercing the body surface, the sheet when in use being oriented in an approximately perpendicular relation to the body surface with the body surface proximal edge having the microprotrusions engaging the body surface.

### Claim 19 (depends on 18)

The device of claim 18, wherein the sheet has a configuration which defines a void for an agent-containing or agent-receiving reservoir.

### Claim 20 (depends on 18)

The device of claim 18, wherein the support contacts a second edge of the sheet, which second edge is opposite to the body surface proximal edge having microprotrusions.

### Claim 21 (depends on 1)

A method of maintaining open agent-transmitting pathways through a body surface having the device of claim 1 positioned adjacent thereto, comprising periodically reapplying a body surface directed force to said device.

### Claim 22 (depends on 21)

The method of claim 21, wherein said reapplying causes said microprotrusions to repierce the body surface.

### Claim 23 (depends on 21)

The method of claim 21, wherein said force is applied manually.

### Claim 24 (depends on 21)

The method of claim 21, wherein the structural support comprises an annular member.

### Claim 25 (depends on 24)

The method of claim 24, wherein the annular member is a circular, square or rectangular annular member having a diagonal cross-member.

### Claim 26 (depends on 21)

The method of claim 21, wherein the structural support has a plurality of cross-members.

### Claim 27 (depends on 26)

The method of claim 26, wherein the plurality of cross-members intersect generally in the center of the structural support.

### Claim 28 (depends on 21)

The method of claim 21, wherein the structural support comprises:
an outer annular member;
an inner annular member having a diameter less than a diameter of the outer annular member; and
the cross-member joins the inner annular member to the outer annular member.

### Claim 29 (depends on 21)

The method of claim 21, wherein the support has greater rigidity to a force applied perpendicular to the body surface than does the member.

### Claim 30 (depends on 21)

The method of claim 21, wherein the support is sufficiently rigid to deflect less than 300 μm under manually applied finger or hand pressing of the device against skin.

### Claim 31 (depends on 30)

The method of claim 30, wherein the support deflects less than 50 μm under said pressing.

### Claim 32 (depends on 21)

The method of claim 21, wherein the support is sufficiently incompressible to compress less than 250 μm under manually applied finger or hand pressing the device against skin.

### Claim 33 (depends on 32)

The method of claim 32, wherein the support compresses less than 50 μm under said pressing.

### Claim 34 (depends on 21)

The method of claim 21, wherein the member comprises a sheet which in use is oriented approximately parallel to the body surface, the sheet having a plurality of openings therein and the plurality of microprotrusions extending from a body proximal surface of the sheet, said microprotrusions being adapted to pierce the body surface.

### Claim 35 (depends on 21)

The method of claim 21, wherein the structural support defines a void for an agent-containing or agent-receiving reservoir.

### Claim 36 (depends on 1)

The device of claim 1, wherein the member has one or more peripheral edges and an interior portion surrounded by the one or more peripheral edges, wherein the structural support extends from the one or more peripheral edges and across the interior portion of the member.

### Claim 37 (depends on 8)

The device of claim 8, wherein the cross-members define a plurality of voids for an agent-containing or agent-receiving reservoir.