# US 6,230,051 B1 · Device for enhancing transdermal agent delivery or sampling

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- Number: US 6,230,051 B1
- Document ID: US6230051B1
- Status: Granted
- Kind: B1
- Application number: 08/877,153
- Filed: 1997-06-17
- Granted: 2001-05-08
- Earliest claimed: 1996-06-18
- Assignees: Alza Corporation
- Inventors: Michel J. N. Cormier; Avtar S. Nat; Armand P. Neukermans; Barry Block
- Web page: https://patentgrep.com/patent/US6230051B1

## CPC

- A61M 37/0015: {by using microneedles}
- A61B 5/14514: {using means for aiding extraction of interstitial fluid, e.g. microneedles or suction}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes}
- A61B 5/150282: {for piercing elements, e.g. blade, lancet, canula, needle}
- A61B 5/150427: {Specific tip design, e.g. for improved penetration characteristics}
- A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing}
- A61B 5/150984: {Microneedles or microblades}
- A61B 5/15105: {Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices}
- A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button}
- A61B 5/15142: {Devices intended for single use, i.e. disposable}
- A61N 1/30: Apparatus for iontophoresis, {i.e. transfer of media in ionic state by an electromotoric force into the body}, or cataphoresis
- A61N 1/303: {Constructional details (electrodes for external use A61N1/0428)}
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61B 17/205: {Vaccinating by means of needles or other puncturing devices}
- 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 2037/0038: {having a channel at the side surface}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0053: {Methods for producing 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)}
- 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 percutaneous agent delivery or sampling device comprising a sheet having a plurality of microblades for piercing the skin for increasing transdermal flux of an agent. The microblades having a relatively sharp angled leading edge which transitions to a relatively gradually angled blade edge.

## Claims

### Claim 1

A device for treating the stratum corneum of a body surface comprising:
a sheet having at least one opening therethrough and a plurality of microblades folded downward from the sheet, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, wherein the width of the microblade at the intersection of the microblade and the sheet is in the range of about 10 microns to about 500 microns and the thickness of the microblade is in the range of about 7 microns to about 100 microns.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first angle is in the range of about 1° to 25° and the angle of the second angled segment is in the range of about 26° to 80°.

### Claim 3 (depends on 1)

The device of claim 1, wherein the first angle is about 15° and the angle of the second angled segment is about 30°.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first angle is about 15° and the angle of the second angled segment is about 35°.

### Claim 5 (depends on 1)

The device of claim 1, further comprising a third angled segment contiguous with the second angled segment and having an angle relative to the axis greater than the angle of the second angled segment.

### Claim 6 (depends on 1)

The device of claim 1, further comprising a plurality of contiguous angled segments wherein each of the subsequent angled segments progressing proximally along the microblade from the second angled seqment have an angle relative to the axis greater than the angle of the preceding angled segment.

### Claim 7 (depends on 1)

The device of claim 1, wherein the first and second angled segments are part of an arc-shaped microblade tip.

### Claim 8 (depends on 1)

The device of claim 1, further comprising a therapeutic agent delivery device connected to the treating device and positioned to deliver a therapeutic agent through the opening to the body surface.

### Claim 9 (depends on 1)

The device of claim 1, further comprising a sampling device connected to the treating device and positioned to sample a substance from the body surface through the opening.

### Claim 10 (depends on 1)

The device of claim 1, wherein the microblades are configured to form pathways in the stratum corneum through which a substance can be introduced or withdrawn.

### Claim 11 (depends on 1)

The device of claim 1, wherein at least a portion of the microblade separates the second angled portion from the sheet.

### Claim 12 (depends on 1)

The device of claim 1 wherein the length of the microblades is less than about 500 micrometers.

### Claim 13

A device for treating the stratum corneum of a body surface comprising:
a sheet having at least one opening therethrough and a plurality of microblades located along a periphery thereof and extending downward from the sheet, at least a portion of the plurality of microblades having first angled segments located distally on each side of an axis along the length of the microblade, each of the first segments having a first angle relative to the axis, and contiguous with the first segments, second segments on each side of the axis each having an angle relative to the axis greater than the first angle, wherein the width of the microblade at the intersection of the microblade and the sheet is in the range of about 10 microns to about 500 microns and the thickness of the microblade is in the range of about 7 microns to about 100 microns.

### Claim 14 (depends on 13)

The device of claim 13, wherein the first angle of each of the first segments is in the range of about 1° to 25° and the angle of each of the second angled segments is in the range of about 26° to 80°.

### Claim 15 (depends on 13)

The device of claim 13, wherein the first angle of each of the first segments is about 15° and the angle of each of the second segments is about 30°.

### Claim 16 (depends on 13)

The device of claim 13, wherein the first angle of each of the first segments are not equal angles.

### Claim 17 (depends on 13)

The device of claim 13, wherein the angle of each of the second segments are not equal angles.

### Claim 18 (depends on 13)

The device of claim 13, further comprising a therapeutic agent delivery device connected to the treating device and positioned to deliver a therapeutic agent through the opening to the body surface.

### Claim 19 (depends on 13)

The device of claim 13, further comprising a sampling device connected to the treating device and positioned to sample a substance from the body surface through the openings.

### Claim 20 (depends on 13)

The device of claim 13, wherein the microblades are configured to form pathways in the stratum corneum through which a substance can be introduced or withdrawn.

### Claim 21 (depends on 13)

The device of claim 13, wherein at least a portion of the microblade separates the second angled portion from the sheet.

### Claim 22 (depends on 10)

The device of claim 10, wherein the length of the microblades is less than about 500 micrometers.

### Claim 23

A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising:
a sheet having at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first angle is about 15° and the angle of the second angled segment is about 30°.

### Claim 24

A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising:
a sheet having at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first angle is about 15° and the angle of the second angled segment is about 35°.

### Claim 25

A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising:
a sheet having at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle; and
a plurality of contiguous angled segments wherein each of the subsequent angled segments progressing proximally along the microblade from the second angled segment have an angle relative to the axis greater than the angle of the preceding angled segment.

### Claim 26

A device for piercing the stratum corneum of a body surface to form pathways through which an agent can be introduced or withdrawn, comprising:
a sheet having at least one opening therethrough and a plurality of microblades extending downward therefrom, at least a portion of the plurality of microblades having a first angled segment located distally on the microblade with a first angle relative to an axis along the length of the microblade, and contiguous with the first angled segment, a second angled segment having an angle relative to the axis greater than the first angle, and wherein the first and second angled segments are part of an arc-shaped microblade tip.

### Claim 27 (depends on 23, 24, 25, 26)

The device of claims 23, 24, 25 or 26, wherein the length of the microblades is less than about 500 micrometers.
