# US 2015/0320348 A1 · Disposable sample collection method and apparatus

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- Number: US 2015/0320348 A1
- Document ID: US20150320348A1
- Status: Published application
- Kind: A1
- Application number: 14/443,513
- Filed: 2013-11-18
- Published: 2015-11-12
- Earliest claimed: 2012-11-16
- Assignees: Lightstat, Inc.
- Applicants: Lightstat, LLC
- Inventors: Ayal Ram
- Web page: https://patentgrep.com/patent/US20150320348A1

## CPC

- A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing}
- A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button}
- A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap}
- 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
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 2200/027: for microfluidic devices
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/0851: Bottom walls
- B01L 2300/0858: Side walls
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

A micro-fluidic device is defined including a channel for conveying blood fluid. A container is defined within the channel for capturing debris generated from the puncture of skin.

## Claims

### Claim 1

A microfluidic sample collection device, comprising:
a channel including a flow path, the channel further comprising container submerged below a flow path in the channel.

### Claim 2 (depends on 1)

A microfluidic sample collection device, as set forth in claim 1, wherein said container comprises an entry wall, opposing side walls, and a back wall opposite said entry wall.

### Claim 3 (depends on 1)

A microfluidic sample collection device, as set forth in claim 1, wherein the container further comprises an entry angle, a first bottom angle, a second bottom angle, and an exit angle proportioned to trap fluid along the flow path in the channel.

### Claim 4 (depends on 2)

A microfluidic sample collection device, as set forth in claim 2, wherein said entry angle is less than ninety degrees.

### Claim 5 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said entry angle ranges from about 15 degrees to 60 degrees.

### Claim 6 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said entry angle ranges from about 25 degrees to 45 degrees.

### Claim 7 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said entry angle is 40 degrees or about 40 degrees.

### Claim 8 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said first bottom angle is less than 90 degrees.

### Claim 9 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said first bottom angle ranges from about 15 degrees to about 60 degrees.

### Claim 10 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said first bottom angle ranges from about 20 degrees to about 40 degrees.

### Claim 11 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said first bottom angle is 30 degrees or about 30 degrees.

### Claim 12 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said second bottom angle ranges from about 80 degrees to about 110 degrees.

### Claim 13 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said second bottom angle is 90 degrees or about 90 degrees.

### Claim 14 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said exit angle ranges from about 70 degrees to 105 degrees.

### Claim 15

A microfluidic sample collection device, as set forth in claim , wherein said exit angle is 70 degrees or about 70 degrees.

### Claim 16 (depends on 3)

A microfluidic sample collection device, as set forth in claim 3, wherein said exit angle is 90 degrees or about 90 degrees.

### Claim 17 (depends on 1)

A microfluidic sample collection device, as set forth in claim 1, wherein the container is parallel to the channel.

### Claim 18 (depends on 1)

A microfluidic sample collection device as set forth in claim 1, wherein said device comprises a housing into which said channel is defined.

### Claim 19 (depends on 1)

A microfluidic sample collection device, as set forth in claim 1, wherein said channel comprises channel sidewalls and a channel floor, wherein the container is set forth below the channel floor.

### Claim 20 (depends on 1)

A microfluidic sample collection device, as set forth in claim 1, further comprising a lancet disposed on the housing.

### Claim 21 (depends on 20)

A microfluidic sample collection device, as set forth in claim 20, wherein the lancet is adjacent to the channel such that fluid accessed by the lancet enters said flow path.

### Claim 22 (depends on 20)

A microfluidic sample collection device, as set forth in claim 20, further comprising a drive mechanism and an actuator, wherein upon actuation said drive mechanism moves said lancet.

### Claim 23

A microfluidic sample collection device comprising:
a housing having a distal end and a proximal end;
a channel defined in said housing such that fluid entering said device travels in a flow path from said distal end to said proximal end;
a container adjacent to said channel and in fluid. communication therewith; and
a lancet disposed in said housing.

### Claim 24 (depends on 23)

A microfluidic sample collection device, as set forth in claim 23, further comprising a drive mechanism for moving said lancet.

### Claim 25 (depends on 24)

A microfluidic sample collection device, as set forth in claim 24, wherein said drive mechanism is a spring, pneumatic device, or hydraulic device that is coupled to said lancet.

### Claim 26 (depends on 24)

A microfluidic sample collection device, as set forth in claim 24, further comprising an actuator for actuating said drive mechanism.

### Claim 27 (depends on 23)

A microfluidic sample collection device, as set forth in claim 23, further comprising a fluid tray connector proximate to said proximal end.

### Claim 28 (depends on 23)

A microfluidic sample collection device, as set forth in claim 23, wherein the container further comprises an entry angle, a first bottom angle, a second bottom angle, and an exit angle proportioned to trap fluid along the flow path in the channel.

### Claim 29 (depends on 28)

A microfluidic sample collection device, as set forth in claim 28, wherein said entry angle is about 40 degrees, said first bottom angle is about 30 degrees, said second bottom angle is about 90 degrees, and said exit angle is about 90 degrees.

### Claim 30 (depends on 23)

A method of obtaining fluid sample from a subject utilizing a microfluidic sample collection device according to claim 23, wherein said fluid sample comprises a reduction in interstitial and cellular debris; said method comprising:
accessing a raw fluid sample at said distal end via application of said lancet to said subject;
allowing said raw fluid sample to flow through said channel such that said raw sample interacts with said container; thereby producing a cleansed fluid sample downstream said container; and
collecting said cleansed fluid sample or subjecting said cleansed fluid sample to analysis.

### Claim 31 (depends on 30)

A method according to claim 30, wherein said collecting step occurs at said proximal end.

### Claim 32 (depends on 23)

A microfluidic sample collection device of claim 23, wherein said lancet is a microneedle.
