# US 2013/0158482 A1 · Rapid delivery and/or receiving of fluids

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- Number: US 2013/0158482 A1
- Document ID: US20130158482A1
- Status: Published application
- Kind: A1
- Application number: 13/812,248
- Filed: 2011-07-12
- Published: 2013-06-20
- Earliest claimed: 2010-07-26
- Assignees: Seventh Sense Biosystems, Inc.
- Inventors: Shawn Davis; Donald E. Chickering; Remin Haghgooie
- Web page: https://patentgrep.com/patent/US20130158482A1

## CPC

- A61M 37/0015: {by using microneedles}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150221: {Valves}
- A61B 5/150229: {Pumps for assisting the blood sampling}
- 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 5/150435: {Specific design of proximal end}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/150511: {Details of construction of shaft}
- A61B 5/150984: {Microneedles or microblades}
- A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button}
- A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing}
- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61B 5/150526: {Curved or bent needles}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0053: {Methods for producing microneedles}
- Y10T 29/4998: Combined manufacture including applying or shaping of fluent material
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

## Claims

### Claim 1

A microneedle structure comprising:
a first plurality of microneedles that each include a base portion and a penetrating portion, the base portions of the first plurality of microneedles being arranged at the periphery of a first closed loop lying in a plane, the penetrating portions of the first plurality of microneedles each extending at a respective angle away from the plane of the first closed loop; and
a second plurality of microneedles that each include a base portion and a penetrating portion, the base portions of the second plurality of microneedles being arranged at a periphery of a second closed loop lying in the plane, the second closed loop being larger than, and surrounding, the first closed loop, the penetrating portions of the second plurality of microneedles each extending at a respective angle away from the plane of the second closed loop.

### Claim 2 (depends on 1)

The structure of claim 1, wherein the first closed loop is a circle, and the penetrating portions extend perpendicularly away from the plane.

### Claim 3 (depends on 1)

The structure of claim 1, wherein the first and second closed loops are concentric circles.

### Claim 4 (depends on 1)

The structure of claim 1, wherein the first closed loop has a circular, elliptical, hexagonal, rectangular, pentagonal, octagonal or irregular shape.

### Claim 5 (depends on 1)

The structure of claim 1, wherein a packing density of the microneedles is at least 2 microneedles per square millimeter.

### Claim 6

(canceled)

### Claim 7 (depends on 1)

The structure of claim 1, wherein the penetrating portion is arranged to pierce human skin and extend at least 100 microns into the skin.

### Claim at position 8

8-10. (canceled)

### Claim 11 (depends on 1)

The structure of claim 1, wherein the microneedles have a combined skin-penetration area of at least about 500 square nanometers.

### Claim at position 10

12-14. (canceled)

### Claim 15 (depends on 1)

The structure of claim 1, wherein each penetrating portion includes a proximal portion that is formed integral with the base portion and a distal portion having a point that is formed at an intersection of at least four surfaces of the penetrating portion;

### Claim 16 (depends on 1)

The structure of claim 1, wherein each penetrating portion includes a proximal portion that is formed integral with the base portion and a distal portion, the distal portion having an approximately hexagon-shaped cross section.

### Claim 17 (depends on 1)

The structure of claim 1, wherein each penetrating portion has a sword shape with a symmetrical V-type knife edge at a periphery of the penetrating portion.

### Claim 18 (depends on 1)

The structure of claim 1, wherein at least some of the microneedles are coated with a substance.

### Claim 19 (depends on 18)

The structure of claim 18, wherein the substance comprises one or more of lidocaine, bupivacaine, and tetracaine.

### Claim 20 (depends on 1)

A device comprising a plurality of the structures recited in claim 1.

### Claim 21 (depends on 1)

The structure of claim 1, wherein the base portions of the first and second pluralities of microneedles are connected together.

### Claim 22

(canceled)

### Claim 23

A method for forming a microneedle structure, comprising:
providing a layer of material having opposed substantially planar sides;
etching the layer of material to define a plurality of microneedles such that bases of the microneedles are arranged at a periphery of a first closed loop and each of the microneedles extends toward a center of the first closed loop; and
etching the layer of material to define a second plurality of microneedles with bases arranged at a periphery of a second closed loop that is arranged around the first closed loop.

### Claim 24 (depends on 23)

The method of claim 23, wherein the first closed loop has a substantially circular, elliptical, hexagonal, rectangular, pentagonal, octagonal or irregular shape.

### Claim 25 (depends on 23)

The method of claim 23, wherein each of the microneedles has a sword shape having a V-type knife edge at a periphery of the microneedle.

### Claim 26 (depends on 23)

The method of claim 23, wherein the step of etching is part of a lithographic patterning process.

### Claim 27 (depends on 23)

The method of claim 23, wherein the step of etching includes isotropic etching of the layer.

### Claim 28 (depends on 23)

The method of claim 23 wherein a distal end of at least one microneedle has an approximately hexagon-shaped cross section.

### Claim 29 (depends on 23)

The method of claim 23, wherein a distal end of at least one microneedle has a point that is formed at an intersection of at least four surfaces.

### Claim 30 (depends on 23)

The method of claim 23, wherein the second plurality of microneedles each extend away from the center of the first closed loop.

### Claim 31 (depends on 23)

The method of claim 23, further comprising:
bending penetrating portions of the first and second pluralities of microneedles away from the plane of the first closed loop.

### Claim 32 (depends on 23)

The method of claim 23, wherein a packing density of the microneedles is at least 2 microneedles per square millimeter.

### Claim at position 29

33-34. (canceled)

### Claim 35 (depends on 23)

The method of claim 23, further comprising:
exposing both sides of the layer, separately or simultaneously, to etching conditions, such that the steps of etching occurs on both sides of the layer of material.

### Claim 36 (depends on 23)

The method of claim 23, wherein at least some of the microneedles are coated with a substance.

### Claim 37 (depends on 36)

The method of claim 36, wherein the substance comprises one or more of lidocaine, bupivacaine, and tetracaine.
