# US 2016/0045148 A1 · Dried blood spot collection device

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- Number: US 2016/0045148 A1
- Document ID: US20160045148A1
- Status: Published application
- Kind: A1
- Application number: 14/825,757
- Filed: 2015-08-13
- Published: 2016-02-18
- Earliest claimed: 2014-08-13
- Assignees: Oregon Health & Science University; Simplexity Product Development Inc.
- Applicants: Oregon Health & Science University; Simplexity Product Development Inc.
- Inventors: Amira Al-Uzri; Dennis Koop; Lisa Bleyle; Andrew Chitty; Robert W. Beauchamp; Asa Weiss; Ethan Vella; Gerold Firl
- Web page: https://patentgrep.com/patent/US20160045148A1

## CPC

- A61B 5/150358: {Strips for collecting blood, e.g. absorbent}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/15019: {Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism (mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198)}
- A61B 5/150213: {Venting means}
- A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)}
- A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)}
- A61B 5/150832: {by topography of the surface, e.g. Braille, embossed printing}
- A61B 5/150908: {by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod}
- 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 5/1513: {comprising linear sliding guides (comprising tooth-shaped elements A61B5/15132)}
- A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing}
- B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- B01L 2200/0678: Facilitating or initiating evaporation
- B01L 2300/0681: Filter
- B01L 2300/069: Absorbents; Gels to retain a fluid
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0838: Capillaries
- B01L 2300/105: using desiccants
- B01L 2400/0406: capillary forces
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE

## Abstract

Apparatuses and methods for dried blood spot (DBS) sample collection are disclosed. A dried blood spot sampling device is configured to deliver blood through a passage to an absorbent disk in the device and control an amount of blood saturating the absorbent disk. The sampling device may include a manually actuatable component adjustable between a first position, in which an outlet of the passage is not in physical contact with the absorbent disk, and a second position, in which the outlet of the passage is in physical contact with the absorbent disk.

## Claims

### Claim 1

A dried blood spot collection device, comprising:
a body defining an inlet of a passage extending from an exterior of the body to an outlet in an interior cavity of the body;
a platform coupled to the body within the interior cavity, the platform holding an absorbent disk in a fixed position on a region of the platform, wherein a central axis of the passage is normal to the platform and intersects the center of the region of the platform;
a manually actuatable component mounted in the body, the manually actuatable component adjustable between a first position and a second position relative to the body, wherein:
in the first position, when an absorbent disk is mounted in the fixed position on the platform, the outlet is not in physical contact with the absorbent disk, and
in the second position, when an absorbent disk is mounted in the fixed position on the platform, the outlet is in physical contact with the absorbent disk.

### Claim 2 (depends on 1)

The device of claim 1, wherein the absorbent disk comprises a filter paper disk having a diameter of approximately 3 millimeters.

### Claim 3 (depends on 1)

The device of claim 1, wherein the absorbent disk comprises a filter paper disk having a diameter of approximately 6 millimeters.

### Claim 4 (depends on 1, 2, 3)

The device of any of claims 1-3, wherein the manually actuatable component is spring-biased to remain in the first position when the manually actuatable component is not actuated.

### Claim 5 (depends on 1)

The device of claim 1, wherein the passage comprises a capillary passage.

### Claim 6 (depends on 1)

The device of claim 1, wherein the passage comprises a screened orifice.

### Claim 7 (depends on 1)

The device of claim 1, further comprising a desiccant mounted in the interior cavity of the body.

### Claim 8 (depends on 1)

The device of claim 1, further comprising a lancet system included in the body.

### Claim 9 (depends on 8)

The device of claim 8, wherein the lancet system is a single-use lancet system.

### Claim 10 (depends on 9)

The device of claim 9, wherein the single-use lancet system comprises a lancet having a needle extending from a body of the lancet, a lancet actuation component, a lancet depth adjustment component, and a lancet port formed as an opening in an outer wall of the body, wherein the lancet is slidably mounted in the interior cavity of the body and is in communication with the lancet actuation component.

### Claim 11 (depends on 10)

The device of claim 10, wherein the lancet is slidably mounted within tracks mounted within the interior cavity such that the lancet is moveable within the interior cavity between a first position where the lancet needle is fully contained within the interior cavity and a second position where a portion of the needle extends outside of the lancet port by a predetermined distance.

### Claim 12 (depends on 10)

The device of claim 10, wherein the lancet depth adjustment component is coupled to one or more blocking elements in the interior cavity, the one or more blocking elements configured to interface with a portion of the lancet to control the length of the portion of the needle which protrudes out of the lancet port following an actuation of the lancet.

### Claim 13 (depends on 10)

The device of claim 10, wherein the lancet actuation component includes a breakable component configured to break after an initial actuation of the lancet so that the lancet actuation component is no longer operable to actuate the lancet following the initial actuation.

### Claim 14 (depends on 10)

The device of claim 10, further comprising a biasing spring positioned between a base component affixed within the interior cavity of body and a base portion of the lancet to supply a biasing force to the lancet in a direction along a central axis of the needle of the lancet and towards the lancet port.

### Claim 15 (depends on 14)

The device of claim 14, further comprising a latch coupled to the lancet actuation component, the latch configured to couple with a portion of the lancet to hold the lancet in a trigger-ready position, wherein, in the trigger-ready position, the biasing spring is compressed between the lancet and the base component and wherein an actuation of the lancet actuation component releases the latch from the lancet.

### Claim 16 (depends on 14)

The device of claim 14, further comprising a counter-biasing spring positioned between a top portion of the lancet and an inner wall of the body to supply a counter-biasing force to the lancet in a direction along a central axis of the needle of the lancet and away from the lancet port.

### Claim 17 (depends on 16)

The device of claim 16, wherein a spring constant of the counter-biasing spring is less than a spring constant of the biasing spring.

### Claim 18 (depends on 16)

The device of claim 16, wherein a spring constant of the counter-biasing spring relative to a spring constant of the biasing spring is such that when the counter-biasing spring and the biasing spring are in equilibrium, the lancet is at a position in the internal cavity in which the needle of the lancet does not protrude out of the lancet port.

### Claim 19 (depends on 1)

The device of claim 1, wherein the manually actuatable component is coupled to the platform such that actuation of the manually actuatable component causes the platform to move toward the outlet in a direction along the central axis of the passage.

### Claim 20 (depends on 1)

The device of claim 1, wherein the manually actuatable component comprises a region of the body adjacent to and including the passage such that actuation of the manually actuatable component causes the passage to move toward the platform.

### Claim 21 (depends on 19)

The device of claim 19, wherein the manually actuatable component is positioned in an aperture in a surface of the body and forms a funnel having inwardly slanted walls which slope from the surface toward the interior cavity and terminate at the inlet.

### Claim 22 (depends on 1)

The device of claim 1, wherein the platform comprises an absorbent material.

### Claim 23 (depends on 22)

The device of claim 22, wherein the secondary absorbent material comprises an absorbent and/or porous disk.

### Claim 24 (depends on 22)

The device of claim 22, wherein the absorbent material is configured to balance relative capillary forces between the absorbent disk and the absorbent material such that blood in excess of a predetermined absorbent disk saturation volume is drawn from the absorbent disk into the secondary absorbent material.

### Claim 25 (depends on 22)

The device of claim 22, wherein an average pore size of the secondary absorbent material is greater than an average pore size of the absorbent disk.

### Claim 26 (depends on 22)

The device of claim 22, wherein the absorbent material is configured to:
provide a capillary pressure between the absorbent disk and the secondary absorbent material, where the capillary pressure is lower than an upper capillary pressure threshold to wick correctly-saturated blood from the absorbent disk so that the volume of blood in the absorbent disk remains greater than a lower specification limit, and where the capillary pressure is greater than a lower capillary threshold so that the volume of blood remaining in the absorbent disk is less than an upper specification limit.

### Claim 27 (depends on 1)

The device of claim 1, further comprising a printed circuit assembly and a switch operably coupled thereto, wherein triggering of the switch causes the printed circuit assembly to capture a time and/or date.

### Claim 28 (depends on 27)

The device of claim 27, wherein the manually actuatable component further includes an extension that engages the switch.