U.S. patent application number 17/188059 was filed with the patent office on 2021-08-19 for dried blood spot collection device.
The applicant listed for this patent is Oregon Health & Science University, Simplexity Product Development Inc.. Invention is credited to Amira Al-Uzri, Robert Beauchamp, Lisa Bleyle, Andrew Chitty, Gerold Firl, Dennis Koop, Ethan Vella, Asa Weiss.
Application Number | 20210251539 17/188059 |
Document ID | / |
Family ID | 1000005564748 |
Filed Date | 2021-08-19 |
United States Patent
Application |
20210251539 |
Kind Code |
A1 |
Al-Uzri; Amira ; et
al. |
August 19, 2021 |
DRIED BLOOD SPOT COLLECTION DEVICE
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.
Inventors: |
Al-Uzri; Amira; (Portland,
OR) ; Koop; Dennis; (Beaverton, OR) ; Bleyle;
Lisa; (Beaverton, OR) ; Chitty; Andrew; (West
Linn, OR) ; Beauchamp; Robert; (Sant Cugat des
Valles, ES) ; Weiss; Asa; (Portland, OR) ;
Vella; Ethan; (Portland, OR) ; Firl; Gerold;
(Poway, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Oregon Health & Science University
Simplexity Product Development Inc. |
Portland
Vancouver |
OR
WA |
US
US |
|
|
Family ID: |
1000005564748 |
Appl. No.: |
17/188059 |
Filed: |
March 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14825757 |
Aug 13, 2015 |
10939861 |
|
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17188059 |
|
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62037068 |
Aug 13, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150503 20130101;
A61B 5/150022 20130101; B01L 2300/0681 20130101; B01L 3/502715
20130101; A61B 5/15113 20130101; B01L 2300/069 20130101; B01L
2300/105 20130101; A61B 5/150832 20130101; A61B 5/150412 20130101;
A61B 5/150358 20130101; B01L 2400/0406 20130101; B01L 2300/0816
20130101; A61B 5/1513 20130101; B01L 3/5023 20130101; A61B 5/150213
20130101; B01L 2200/0678 20130101; B01L 2300/0838 20130101; A61B
5/15144 20130101; A61B 5/150908 20130101; A61B 5/15117 20130101;
A61B 5/15019 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; B01L 3/00 20060101 B01L003/00; A61B 5/151 20060101
A61B005/151 |
Goverment Interests
ACKNOWLEDGMENT OF GOVERNMENT SUPPORT
[0002] This invention was made with government support under Grant
No. UL1TR000128 awarded by the National Institutes of Health. The
government has certain rights in the technology.
Claims
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.
2. The device of claim 1, wherein the absorbent disk comprises a
filter paper disk having a diameter of approximately 3
millimeters.
3. The device of claim 1, wherein the absorbent disk comprises a
filter paper disk having a diameter of approximately 6
millimeters.
4. The device of any of claim 1, wherein the manually actuatable
component is spring-biased to remain in the first position when the
manually actuatable component is not actuated.
5. The device of claim 1, wherein the passage comprises a capillary
passage.
6. The device of claim 1, wherein the passage comprises a screened
orifice.
7. The device of claim 1, further comprising a desiccant mounted in
the interior cavity of the body.
8. The device of claim 1, further comprising a lancet system
included in the body.
9. The device of claim 8, wherein the lancet system is a single-use
lancet system.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. The device of claim 16, wherein a spring constant of the
counter-biasing spring is less than a spring constant of the
biasing spring.
18. 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.
19. 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.
20. 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.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application is a Continuation patent application
which claims priority to U.S. Non-Provisional patent application
Ser. No. 14/825,757 filed Aug. 13, 2015 entitled "DRIED BLOOD SPOT
COLLECTION DEVICE" which claims benefit of U.S. Provisional Patent
Application No. 62/037,068, filed Aug. 13, 2014, the disclosures of
which are hereby incorporated by reference in their entirety.
FIELD
[0003] The present disclosure relates to the field of dried blood
spot testing, and, more specifically, to single-use dried blood
spot sampling devices.
BACKGROUND
[0004] Blood tests may be performed on blood samples for screening,
diagnosing, and monitoring various medical conditions. Various
approaches are used to collect blood samples for blood tests.
Venipuncture is a widely-used blood collection procedure that
generally relies on trained medical practitioners, specialized
equipment, and sterilization protocols to collect liquid blood
samples for processing. Blood samples collected by venipuncture
usually are separated by centrifugation and stored under
refrigeration.
[0005] Another blood sample collection approach is dried blood spot
(DBS) sampling. DBS is a form of biosampling in which blood samples
are blotted and dried on a suitable absorbent material, e.g.,
filter paper. In some approaches, a lancet may be used to draw
blood, e.g., via a fingerstick, and the blood sample may be
transferred to one or more delineated circular regions, or spots,
on filter paper. The spotted filter paper with the blood samples
may be air dried for several hours to obtain a DBS specimen that
may be shipped to an analytical laboratory and analyzed using
various methods such as DNA amplification or high-performance
liquid chromatography (HPLC). In some approaches, a blood spot on
DBS paper may be sampled by punching out a smaller diameter hole in
the paper from within the blood spot or tearing off sections of the
blood spot. For example, a blood sample may be transferred to a
delineated circular region having a diameter of approximately 10 mm
on absorbent paper and, during processing, a 3-6 mm hole may be
punched out of the 10 mm blood sample spot for analysis. The
punched sample may then be placed in a tube and eluted with a
buffer so that the extracted sample can undergo various diagnostic
tests.
[0006] Compared with liquid blood specimens, e.g., as collected via
venipuncture, DBS specimens may have a longer lifespan, have a
reduced need for refrigeration, pose less of a biohazard risk to
handlers, utilize less blood, and be easier to transport or store.
Potential applications of DBS sampling include screening,
diagnosis, monitoring, and research of various medical
conditions/populations including HIV, epilepsy, cancer, transplant
patients, etc.
[0007] The inventors herein have recognized various issues with
current approaches to DBS sampling. In current DBS sampling
approaches, biological sample distribution across the collection
material is dependent on sample application techniques and can
result in uneven analyte concentrations across the material. For
example, some approaches require a patient to place a large drop of
blood, e.g., about 30 .mu.L, on DBS filter paper in order to
attempt to saturate a large area of the filter paper, e.g., a 10 mm
spot. Saturating such a large area of the filter paper may lead to
a non-homogenous distribution of the blood over the filter paper,
which may lead to errors in sample analysis due to inaccurate
sample volumes. Additionally, many DBS approaches require a user to
physically touch the DBS paper in order to transfer the blood to
the paper. However, touching the DBS paper can produce non-uniform
blood sample spots, which may also reduce accuracy.
[0008] As described above, in some approaches, a sample disk may be
punched out from a larger diameter blood spot or sections may be
tom off from the blood spot for analysis. However, punching out a
sample disk or tearing off sections from a blood spot region of
sample paper may lead to increased variability and errors in sample
analysis. For example, variable analytical results may occur when a
sub-sample within a sample spot is removed manually with a
hole-punch or when sections of the blood spot are torn off.
[0009] Additionally, many DBS sampling approaches rely on patients
and/or clinicians to perform multiple steps that may be cumbersome
for use by patients. For example, some approaches require a patient
to use a glass capillary tube to draw blood from a lanced finger
and then to place the capillary tube containing the blood sample
into a holder to saturate a spot on filter paper. Such an approach
may be difficult to implement and may additionally lead to uneven
blood distribution across the spot and under-saturation or
over-saturation of the DBS material. Further, such approaches may
require the use of many separate components, such as a lancet,
filter papers, a holder for drying, and containers with a drying
agent for transport. These separate components can be cumbersome
for use even by a skilled technician, and may not suitable for use
by a patient alone. Further, such approaches may require disposal
of blood collection materials as hazardous waste, e.g., used
lancets, capillary tubes, etc.
SUMMARY
[0010] The present disclosure is directed to dried blood spot (DBS)
collection devices and methods of using such devices. In one
example approach, a dried blood spot sampling device is configured
to deliver blood through a passage to an absorbent disk in the
device, e.g., a 3 mm or 6 mm filter paper disk, and control an
amount of blood saturating the absorbent disk. Although examples of
circular absorbent disks are often discussed herein, an absorbent
disk may have any suitable footprint. The sampling device may
additionally include a manually actuatable component adjustable
between a first position, where an outlet of the passage is not in
physical contact with the absorbent disk, and a second position,
where the outlet of the passage is in physical contact with the
absorbent disk.
[0011] Some embodiments of the DBS collection device may
additionally include a lancet system incorporated into the device,
thereby providing a self-contained, easy-to-use, and safe method
for obtaining a DBS sample. For example, the device can potentially
be used remotely and shipped using regular mail to a clinical lab
without the need for disposing of or shipping biohazardous
components.
[0012] For example, in some embodiments, the DBS device may
additionally include a single-use, adjustable-depth, retracting
lancet incorporated within the device for lancing a finger of a
user. After the finger is lanced, the user may place the lanced
finger at an inlet of the passage so that blood is drawn into the
passage. The user may then actuate the manually-actuatable
component to put the outlet of the passage into physical contact
with the sample disk so that a precise amount of blood is
transferred from the passage to the sample disk to precisely
saturate the sample disk. After saturation of the sample disk, the
user may release the manually actuatable component so that the
outlet is no longer in physical contact with the sample disk. The
DBS device may then be sealed and shipped, e.g., via mail, to a
testing center, for example.
[0013] In such an approach, a precise volume of blood may be
delivered via the passage to a specifically-sized sample disk to
precisely saturate the disk, thereby providing a reproducible,
accurate, and uniform distribution of blood over the disk. In this
approach, the sample disk may be sized such that no additional
manipulation of the disk, such as tearing off or punching out
portions of the disk, are needed to prepare the specimen for
testing at a lab. In various embodiments, this may decrease
variability and error, and may reduce processing time at the lab.
Additionally, such an approach may be less intrusive to the patient
and may use a smaller volume of blood compare to previous
approaches, such as venipuncture and approaches which attempt to
saturate a large dot or substrate, as described above.
[0014] Compared to clinical blood collection approaches such as
venipuncture, various ones of the approaches disclosed herein have
the potential to reduce costs, e.g., phlebotomy costs, and decrease
impact on the user. For example, since some embodiments of the
devices disclosed herein may be used remotely and then mailed to a
clinic, such devices may provide cost savings from travel, fewer
points of contact, and decreased barriers to compliance.
[0015] This Summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This Summary is not intended to identify
key features or essential features of the disclosed subject matter,
nor is it intended to be used to limit the scope of the disclosed
subject matter. Furthermore, the disclosed subject matter is not
limited to implementations that address any or all disadvantages
noted in any part of this disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a schematic depiction of a side view of an example
of a dried blood spot collection device, in accordance with various
embodiments;
[0017] FIG. 2 is a perspective view of another example of a dried
blood spot collection device, in accordance with various
embodiments;
[0018] FIG. 3 is another perspective view of an example of a dried
blood spot collection device, in accordance with various
embodiments;
[0019] FIG. 4 is a schematic depiction of an example of a dried
blood spot collection device, in accordance with various
embodiments;
[0020] FIG. 5 is another schematic depiction of an example of a
dried blood spot collection device, in accordance with various
embodiments;
[0021] FIG. 6 is another schematic depiction of an example of a
dried blood spot collection device, in accordance with various
embodiments;
[0022] FIG. 7 is a perspective view of an example of a dried blood
spot collection device, in accordance with various embodiments;
[0023] FIG. 8 illustrates a front perspective view of another
example of a dried blood spot collection device, in accordance with
various embodiments;
[0024] FIG. 9 is a back perspective view of the dried blood spot
collection device shown in FIG. 8, in accordance with various
embodiments;
[0025] FIG. 10 is a front view of the dried blood spot collection
device shown in FIG. 8, in accordance with various embodiments;
[0026] FIG. 11 is a back view of the dried blood spot collection
device shown in FIG. 8, in accordance with various embodiments;
[0027] FIG. 12 is a side view along a length of the dried blood
spot collection device shown in FIG. 8, in accordance with various
embodiments;
[0028] FIG. 13 is a side view along a width of the dried blood spot
collection device shown in FIG. 8, in accordance with various
embodiments;
[0029] FIG. 14 is a detail view of the manually actuatable
component included in the example device shown in FIG. 8, in
accordance with various embodiments;
[0030] FIG. 15 is another detail view of the manually actuatable
component included in the example device shown in FIG. 8, in
accordance with various embodiments;
[0031] FIG. 16 is a front perspective view of another example of a
dried blood spot collection device, in accordance with various
embodiments;
[0032] FIG. 17 is a front view of the a dried blood spot collection
device shown in FIG. 16, in accordance with various
embodiments;
[0033] FIG. 18 is another front perspective view of the a dried
blood spot collection device shown in FIG. 16, in accordance with
various embodiments;
[0034] FIG. 19 is a back view of the a dried blood spot collection
device shown in FIG. 16, in accordance with various
embodiments;
[0035] FIG. 20 is a side view of the a dried blood spot collection
device shown in FIG. 16, in accordance with various
embodiments;
[0036] FIG. 21 is a back view of the a dried blood spot collection
device shown in FIG. 16 shown with internal components exposed, in
accordance with various embodiments;
[0037] FIG. 22 is a cross-sectional view of another example of a
dried blood spot collection device, in accordance with various
embodiments; and
[0038] FIG. 23 illustrates another example of a dried blood spot
collection device, in accordance with various embodiments.
DETAILED DESCRIPTION
[0039] The following detailed description is directed to
apparatuses and methods for dried blood spot (DBS) sampling. In the
following detailed description, reference is made to the
accompanying drawings which form a part hereof, and in which are
shown, by way of illustration, embodiments that may be practiced.
It is to be understood that other embodiments may be utilized and
structural or logical changes may be made without departing from
the scope of the disclosure. Therefore, the following detailed
description is not to be taken in a limiting sense. Various
operations may be described as multiple discrete operations in
turn, in a manner that may be helpful in understanding embodiments;
however, the order of description should not be construed to imply
that these operations are order-dependent.
[0040] FIG. 1 is a schematic depiction of a side view of an example
embodiment of a DBS collection device 100. DBS collection device
100 includes a body 102 that defines an inlet 104 of a passage 106
extending from an exterior 108 of the body 102 to an outlet 110 in
an interior cavity 112 of the body 102. In some embodiments, as
shown in the illustrations of FIGS. 1-21, passage 106 may include a
capillary passage or capillary tube. However, it should be
understood that any suitable passage or orifice may be used without
departing from the scope of the present disclosure. For example, as
shown in FIG. 22, passage 106 may include a screened orifice. The
body 102 may include any suitable material or combination of
materials, e.g., plastic, glass, stainless steel, etc.
[0041] In the example embodiment shown in FIG. 1, body 102 includes
a top plate 124 coupled to a bottom plate 126 which may define the
interior cavity 112. Both the top plate 124 and the bottom plate
126 may have similar and/or complementary shapes, e.g., the top and
bottom plates may have substantially the same length, width, and
thickness. However, in some examples, e.g., as shown in FIG. 3 and
described below, the top plate 124 and the bottom plate 126 may
have substantially the same length and width but may have different
thicknesses. Further, in other examples, the top plate 124 and the
bottom plate 126 may have different shapes, e.g., different
lengths, widths, and/or thicknesses. The top and bottom plates 124
and 126 may be coupled together in any suitable way. For example,
the top and bottom plates 124 and 126 may be affixed to each other
via a suitable adhesive and/or via one or more clamps, rivets,
bolts, screws, clips, latches, pins, pegs, or other coupling
components. In some examples, the top and bottom plates 124 and 126
may be molded together after an installation of various internal
components in the top and bottom plates 124 and 126. Example
components which may be included within body 102 are described
below.
[0042] DBS collection device 100 includes a platform 114 coupled to
the body 102 within the interior cavity 112. Platform 114 is
configured to hold an absorbent disk 116 in a fixed position on a
circular region 118 of the platform 114. The absorbent disk 116 may
include any suitable DBS material, e.g., a filter paper disk, a
porous polymer, etc. In some examples, the absorbent disk 116 may
be sized such that no additional manipulation of the absorbent
disk, such as tearing off or punching out portions of the absorbent
disk 116, are needed to prepare the specimen for testing at a lab.
For example, the absorbent disk 116 may include a 3 mm filter paper
disk or a 6 mm filter paper disk.
[0043] In example illustrated in FIG. 1, platform 114 is formed as
a circular cut-out in a top surface 144 of bottom plate 126. The
circular cut-out may be sized to receive and hold an absorbent disk
(e.g., the absorbent disk 116) of a predetermined size, e.g., a 3
mm or 6 mm diameter. Platform 114 is positioned directly beneath
capillary outlet 110 of passage 106 so that a central axis 120 of
the passage 106 is normal to, i.e., is perpendicular to or forms a
right angle with, the platform 114 and intersects the center 122 of
the circular region 118 of the platform 114.
[0044] In the example embodiment shown in FIG. 1, a funnel-shaped
indentation 128 is included in the top surface 136 of the top plate
124 of body 102. Indentation 128 is defined by inwardly sloping
walls 132 which form a funnel shape to assist in positioning a
fingertip above the capillary inlet and to direct blood samples
from a lanced finger placed into the indentation 128 into the
capillary inlet 104. The depth 134 of walls 132 of indentation 128
from top surface 136 decreases with increasing distance from the
capillary inlet 104, thereby forming a funnel in the top plate 124
for directing a blood sample introduced at the indentation 128 into
the capillary inlet 104. At the indentation 128, the top surface
136 is recessed and slopes inwardly toward the capillary inlet 104.
As shown in FIGS. 2, 16, 17, and 22, and described below, in some
examples, the indentation 128 may be substantially circular in
shape when viewed from above so as to function as a funnel for
finger positioning and directing a blood sample into the passage
106. The indentation 128 may be sized to encompass and position a
fingertip in a predetermined location. For example, a diameter 138
of the indentation at the top surface may be at least 1.5 cm. The
diameter of the indentation 128 may decrease from the diameter 138
at the top surface 136 to a diameter 140 of capillary inlet
104.
[0045] The passage 106 may have a predetermined length 142 along
the central axis 120. The length 142 and diameter 140 of the
passage 106 may be specifically sized to hold a predetermined
amount of blood for delivery to the absorbent disk 116. For
example, the length 142 and diameter 140 of the passage 106 may be
sized to hold a volume of blood substantially equal to a volume of
blood that would sufficiently saturate the absorbent disk 116. The
amount of saturation that is "sufficient" may depend on the test
being run (e.g., with a mass spectrometer configured to analyze the
blood). In some embodiments, 7.4 microliters may be a sufficient
amount. In some examples, the passage 106 may be sized to hold a
volume of blood greater by a predetermined amount (e.g., a fixed
volume or percentage) than the volume of blood which would
sufficiently saturate the absorbent disk 116. In some embodiments,
the dimensions of the absorbent disk 116 may be selected to allow
the absorbent disk 116 to hold a predetermined volume of blood, and
thereby utilize the absorbent disk 116 as a metering device for the
amount of blood stored therein. In various embodiments, the nominal
value of this predetermined volume may depend on the particular
test to be performed on the blood, as noted above with reference to
the passage 106.
[0046] In the example embodiment shown in FIG. 1, the lower plate
126 defines an air vent channel 130 positioned directly below the
absorbed disk 116. The air vent channel 130 may include an aperture
extending through the bottom plate in a direction along the central
axis 120. The air vent channel 130 may share a central axis with
passage 106, e.g., central axis 120 may be a central axis of both
the passage 106 and the air vent channel 130. When included, the
air vent channel 130 may provide ventilation to the interior cavity
112 to assist in drying a blood sample delivered to the absorbent
disk 116, and may provide a pathway for excess blood not absorbed
by the absorbent disk 116.
[0047] FIG. 2 is a perspective view of another example embodiment
of a DBS collection device 100. Like-numbered elements shown in
FIG. 2 correspond to like-numbered elements shown in FIG. 1 and
described above. DBS device 100 shown in FIG. 2 includes a body 102
having a length 206, a width 208, and a thickness 210. As shown in
FIG. 2, the length 206 may be substantially the same as the width
208 and both the length 206 and the width 208 may be greater than
the thickness 210, e.g., the thickness 210 may be at least 4 times
smaller than both the length 206 and width 208. However, in other
examples, the length 206 may be greater than the width 208 or the
width 208 may be greater than the length 206.
[0048] In the example embodiment shown in FIG. 2, the platform 114
includes an absorbent or porous material mounted on the top surface
144 of the bottom plate 126. Other example embodiments wherein the
platform 114 includes an absorbent or porous material are shown in
FIGS. 16-22 and described below. The absorbent or porous material
may be a porous polymer material, absorbent paper, or any other
suitable absorbent or porous material which functions to absorb
excess blood that is not absorbed into the absorbent disk 116. As
described in more detail below, in various embodiments, the
platform 114 may have physical properties that serve to balance
capillary forces between the absorbent disk 116 and the platform
114 so that excess blood in the absorbent disk 116 is wicked into
the platform 114 so that the absorbent disk 116 is saturated with a
precise amount of blood for testing. As noted above, the platform
114 may include an absorbent material positioned below the
absorbent disk 116 and in physical contact with a bottom portion of
the absorbent disk 116. In various embodiments, the absorbent
material of the platform 114 may be a different material than the
absorbent disk 116, or may be a same material as absorbent disk
116, but the absorbent disk 116 and the absorbent material of the
platform 114 are two different components.
[0049] Characteristics of the absorbent material included in the
platform 114, e.g., average pore size, porosity, shape, volume,
surface area, etc., may be selected to provide a balance of
relative capillary forces between the absorbent disk 116 and the
platform 114 such that blood in excess of a predetermined absorbent
disk saturation volume is drawn from the absorbent disk 116 into
the platform 114. As one non-limiting example, the platform 114 may
include an absorbent disk composed of an absorbent material with a
diameter 212 greater than the diameter 214 of the absorbent sample
disk 116. In some examples, diameter 212 may be at least twice as
large as diameter 214. However, in other examples, diameter 212 may
be less than or substantially equal to diameter 214. In this
example, the platform 114 comprising the absorbent material may be
positioned and sandwiched between the top plate 124 and bottom
plate 126. As noted above, the top and bottom plates 124 and 126
may be coupled together in any suitable way. In the example
illustrated in FIG. 2, the top plate 124 and bottom plate 126 are
shown coupled together by a plurality of coupling elements 202
positioned adjacent to an outer perimeter of body 102. As one
example, the coupling elements 202 may include screws, e.g. machine
screws, threaded directly into the bottom plate 126. As another
example, the coupling elements 202 may include nuts coupled to
bolts which extend through apertures in the top and bottom plates
124 and 126. It should be understood that any suitable coupling
components may be used to hold the top and bottom plates 124 and
126 together, e.g., bolts, screws, clamps, rivets, clips, latches,
pins, pegs, etc. In some examples, other approaches may be used to
couple the top and bottom plates 124 and 126 together without
external fasteners. For example, the top and bottom plates 124 and
126 of the DBS collection device 100 may be snapped together with
plastic features extending from of each half and/or an adhesive or
ultrasonic welding may be used to couple the top and bottom plates
124 and 126 together. When the top and bottom plates 124 and 126
are coupled together, they hold the platform 114 and the absorbent
disk 116 in a fixed position below the passage 106.
[0050] The embodiment shown in FIG. 2 also includes an indentation
128 which assists in positioning a lanced finger and directing
blood from the lanced finger into the passage 106 and onto the
absorbent disk 116. However, in this example, indentation 128 is
formed in a raised portion 230 of the top plate 124 and extends a
non-zero distance above the top surface 136 of the top plate 124.
In this example, the raised portion 230 takes the form of a
cylinder coupled to top surface 136 at a base of the cylinder. The
interior of the cylinder includes walls which taper inwardly to
form a funnel which assists in finger positioning and directing a
blood sample into the passage 106. Excess blood not absorbed by the
absorbent disk 116 may be absorbed by the platform 114 comprising
the porous or absorbent material. Since the platform 114 is
configured to absorb excess blood in this example, occurrences of
oversaturation of the absorbent disk 116 may be reduced, thereby
potentially increasing accuracy when the DBS sample is processed
for testing.
[0051] FIG. 3 is a perspective view of another example embodiment
of a DBS collection device 100. Like-numbered elements shown in
FIG. 3 correspond to like-numbered elements shown in FIGS. 1 and 2
and described above. In the example embodiment shown in FIG. 3, the
platform 114 includes a plurality of capillary channels 302 formed
from raised regions 304 in the top surface 144 of the bottom plate
126. The capillary channels 302 radiate outwardly in the top
surface 144 of the bottom plate 126 from beneath the absorbent disk
116 and open into larger channels 310 formed in the bottom plate
126. The capillary channels 302 may wick excess blood away from the
absorbent disk 116 in order to reduce uneven saturation of the
absorbent disk. For example, the capillary channels 302 may be
sized to provide a balance of relative capillary forces between the
absorbent disk 116 and the capillary channels 302 such that blood
in excess of a predetermined absorbent disk saturation volume
(e.g., a fixed volume or percentage) is drawn from the absorbent
disk 116 into the capillary channels 302. Additionally, the
capillary channels 302 may assist in accelerating drying of a blood
sample transferred to the absorbent disk 116. In some examples, one
or more air vents 306 may be included in the body 102. The air
vents 306 may be formed as grooves or slots in the top surface 144
of the bottom plate 126 and may be in communication with the
capillary channels 302 to assist in drying blood in the absorbent
disk 116 and in the capillary channels 302. Any suitable design and
any number of capillary channels 302 may be used without departing
from the scope of the present disclosure. The example shown in FIG.
3 shows four capillary channels 302 which extend from central axis
120 toward an outer perimeter of the body 102 and open into larger
channels 310 positioned outside of a footprint of the absorbent
disk 116. Raised regions 304 in the bottom plate may extend below
the absorbent disk 116 to support the absorbent disk 116 in a fixed
position directly beneath the passage 106.
[0052] FIG. 4 shows a schematic depiction of another example
embodiment of a DBS collection device 100. In this example, DBS
collection device 100 additionally includes a lancet system 418
described in more detail below. It should be understood that
inclusion of a lancet system in DBS collection device 100 is
optional and, in some embodiments, a lancet system may be omitted.
Like-numbered elements shown in FIG. 4 correspond to like-numbered
elements shown in FIGS. 1-3 and described above.
[0053] The DBS collection device 100 shown in FIG. 4 includes a
body 102 that defines an inlet 104 of a passage 106 extending from
an exterior 108 of the body 102 to an outlet 110 in an interior
cavity 112 of the body 102. As remarked above, passage 106 may
include any suitable passage or orifice, e.g., a capillary passage
or a screened orifice. The body 102 may include any suitable
material and may have a variety of dimensions and shapes,
additional examples of which are described below.
[0054] The DBS collection device 100 shown in FIG. 4 includes a
platform 114 coupled to the body 102 within the interior cavity 112
of the body 102. Platform 114 is configured to hold a
specifically-sized absorbent disk 116 in a fixed position on a
circular region 118 of the platform 114. In the illustrated
embodiment, platform 114 is positioned directly beneath outlet 110
of passage 106 so that a central axis 120 of the passage 106 is
normal to the platform 114 and intersects the center 122 of the
circular region 118 of the platform 114. The passage 106 may have a
predetermined length 142 along the central axis 120 and a
predetermined diameter 140 or gauge. For example, the length 142
and diameter 140 of the passage 106 may be specifically sized to
hold a predetermined amount of blood for delivery to the absorbent
disk 116.
[0055] In some examples, the DBS collection device 100 may include
a desiccant 412 in interior cavity 112 to assist in drying blood
transferred to the absorbent disk 116 and to maintain a reduced
humidity level inside the DBS collection device 100. Desiccant 412
may include any suitable hygroscopic substance that induces or
sustains a state of dryness. Example desiccants include silica,
activated charcoal, calcium sulfate, calcium chloride, molecular
sieves, etc. Desiccant 412 may be mounted to or coupled within the
interior cavity 112 of body 102 at any suitable location and in any
suitable way. In some examples, an inner wall of body 102 may
include one or more desiccant mounting components for holding
desiccant 412 in a fixed position in the interior cavity 112.
[0056] The DBS collection device 100 may optionally include a
lancet system 418. Lancet system 418 may include a lancet 420
having a needle 422 extending from a body 421 of the lancet 420, a
lancet actuation component 426, a lancet depth adjustment component
424, and a lancet port 462 formed as an opening in an outer wall of
body 102. The needle 422 may have any suitable length and gauge.
For example, the needle 422 may have a gauge of approximately 23.
In some examples, the length of the needle 422 used may be selected
based on a desired or nominal needle penetration depth. As an
example, the selected needle length may be such that the needle 422
extends a distance of approximately 2 mm out of body 102 when
actuated.
[0057] The lancet 420 may be slidably mounted in the interior
cavity 112 of body 102 and in communication with the lancet
actuation component 426 such that when the lancet actuation
component 426 is manually actuated, a portion of the needle 422 is
projected out through the lancet port 462 and into the exterior 108
of the body 102. For example, the lancet system 418 may include a
biasing spring 458 which is coupled to or interfaces with a base
component 456 affixed within the interior cavity 112 of body 102.
The biasing spring 458 may be in contact with a base portion of
lancet 420, e.g., a side of lancet 420 opposing needle 422, to bias
the lancet 420 toward the lancet port 462. In particular, the
biasing spring 458 may supply a biasing force to the lancet 420 in
a direction along a central axis of the needle 422 of the lancet
420 towards the lancet port 462.
[0058] In some examples, the spring-biased lancet 420 may be held
in a trigger-ready position within the interior cavity 112 by a
latch 454 coupled to the lancet actuation component 426. For
example, in the trigger-ready position, the biasing spring 458 may
be compressed between the lancet 420 and the base component 456 to
confer a potential energy to the biasing spring 458 which may be
released, e.g., transformed to kinetic energy, in response to
removal of the latch 454. Actuation of the lancet actuation
component 426 may release the latch 454 from the lancet 420,
thereby permitting the biasing spring 458 to propel the lancet 420
so that the needle 422 of the lancet 420 protrudes out of the
lancet port 462 by a predetermined distance. For example, the
lancet actuation component 426 may include a button which extends
at least partially into the exterior 108 of body 102 so that a user
can engage or press the button in order to actuate the lancet
420.
[0059] The lancet 420 may be slidably mounted within tracks 470
mounted within the interior cavity 112 such that the lancet 420 is
moveable within the interior cavity 112 between a first position
where the needle 422 is fully contained within the interior cavity
112 or does not protrude out of the lancet port 462 and a second
position where a length of the needle 422 extends outside of the
lancet port 462. As an example, the lancet 420 may include slots or
grooves which are complementary to tracks 470 so that the lancet
420 can slide within the tracks 470 between the first and second
positions. In some examples, the length of the portion of the
needle 422 projected out of the lancet port 462 may be adjusted via
a manual adjustment of the lancet depth adjustment component 424.
For example, the lancet depth adjustment component 424 may include
one or more blocking elements 450 that interface with a portion of
the lancet 420 to control the length of the needle 422 that
protrudes out of the lancet port 462 following actuation of the
lancet 420. In some embodiments, the lancet depth adjustment
component 424 may include a slidable component extending at least
partially outside of body 102. Adjustment of the lancet depth
adjustment component 424 may include sliding a blocking element 450
into a path extending parallel to the central axis of needle 422
from a position on atop surface 480 of the body 421 adjacent to
abase of needle 422. When slid into such a position, the blocking
element 450 may decrease the length of the needle 422 which
protrudes from the lancet port 462, thereby decreasing a
penetration depth of the needle 422 into a finger positioned on the
lancet port 462 when the lancet 420 is actuated.
[0060] In some examples, lancet system 418 may be a single-use
lancet system, such that, after an initial actuation of the lancet
420 which causes the needle 422 to protrude out of the lancet port
462, the needle 422 automatically retracts back into the interior
cavity 112 and stays in the interior cavity 112 during subsequent
lancet actuation attempts following the initial actuation. For
example, the lancet actuation component 426 may include a breakable
component 452 which breaks or becomes non-functional, i.e., no
longer operable to actuate the lancet 420, after an initial
actuation of the lancet 420 so that the lancet actuation component
426 is no longer functional following the initial actuation.
[0061] In some examples, the lancet system 418 may include a
counter-biasing spring 460 which interfaces with the lancet 420 to
retract the needle 422 after actuation of the lancet 420. For
example, a first end of the counter-biasing spring 460 may be in
contact with top surface 480 of lancet body 421 and a second end of
the counter-biasing spring 460, opposing the first end, may be in
contact with an inner surface of body 102 at a position adjacent to
lancet port 462. The counter-biasing spring 460 may bias the lancet
420 away from the lancet port 462. In particular, the
counter-biasing spring 460 may supply a counter-biasing force to
the lancet 420 in a direction along a central axis of the needle
422 of the lancet 420 away from the lancet port 462. In some
embodiments, the counter-biasing force provided by the
counter-biasing spring 460 may be less than the biasing force
provided by the biasing spring 458. For example, a spring constant
of the counter-biasing spring 460 may be less than a spring
constant of the biasing spring 458. The spring constant of the
counter-biasing spring 460 relative to the spring constant of the
biasing spring 458 may be such that, following an initial
protrusion of the needle 422 out of the lancet port 462, the lancet
420 returns to an equilibrium position governed by the spring
constant of the biasing spring 458 and the spring constant of the
counter-biasing spring 460. In the equilibrium position, the needle
422 of the lancet 420 may be fully contained inside the interior
cavity 112 of the body 102 and/or may not extend outside of the
lancet port 162.
[0062] In some examples, DBS collection device 100 may include
packaging 414. Packaging 414 may include any suitable packaging
components which seal the body of the DBS collection device 100,
e.g., packaging 414 may include a plastic bag or container. For
example, the packaging 414 may be used to form a watertight seal
around the DBS collection device 100, provide UV protection of the
DBS collection device 100, and/or provide insulation to the DBS
collection device 100, etc. As an example, following manufacture of
DBS collection device 100, the DBS collection device 100 may be
sealed in a suitable watertight protective bag or container
providing the packaging 114. In order to use the DBS collection
device 100, a user may unseal the DBS collection device 100 by
opening the packaging 114 and removing the body 102 from the
packaging 114. After a blood sample is delivered to the absorbent
disk 116 in the device 100, the user may then reseal the DBS
collection device 100 using a suitable bag or container so that the
sealed DBS collection device 100 can be transported to a testing
facility.
[0063] In some examples, DBS collection device 100 may include
indicia 440 on one or more regions of an exterior surface of the
body 102. For example, the indicia 440 may include one or more of
markings, symbols, serial numbers bar codes, optical labels, etc.
The indicia may be used to label or identify information associated
with the DBS collection device 100 and/or information associated
with a user of the DBS collection device 100. As another example,
indicia 440 may be included adjacent to lancet depth adjustment
component 424 to indicate different lancet needle depth options as
shown in FIGS. 8, 10, 16-18, and 22 and described below.
[0064] In some embodiments, the DBS collection device 100 may
include a manually actuatable component mounted in the body 102
configured to adjust the position of the absorbent disk 116
relative to the outlet 110. In particular, the manually actuatable
component may be adjustable between a first position and a second
position relative to the body 102. In the first position, when an
absorbent disk 116 is mounted in a fixed position on the circular
region 118 of the platform 114, the outlet 110 is not in physical
contact with the absorbent disk 116 so that there is a non-zero
distance 408 between the outlet 110 and a top surface of the
absorbent disk 116. In the second position, when an absorbent disk
116 is mounted in the fixed position on the platform 114, the
outlet 110 is in physical contact with the absorbent disk 116,
i.e., edges of the passage 106 at the outlet 110 opening touch the
surface of the absorbent disk 116.
[0065] The manually actuatable component may be included in DBS
collection device 100 in a variety of ways, some examples of which
are described below. In one example shown in FIG. 5, a manually
actuatable component 502 may include or be coupled to platform 114
such that actuation of the manually actuatable component 502 causes
the platform 114 to move toward the outlet 110 in a direction along
the central axis 120 of the passage 106 until the absorbent disk
116 on the platform 114 is in physical contact with, e.g.
physically touches, the outlet 110. In this example, manually
actuatable component 502 is adjustable between a first position and
a second position relative to the body 102, wherein, in the first
position when an absorbent disk 116 is mounted in a fixed position
on the circular region 118 on the platform 114, the outlet 110 is
not in physical contact with the absorbent disk 116 (e.g., does not
touch the absorbent disk 116 as shown in FIG. 4), and, in the
second position when an absorbent disk 116 is mounted in the fixed
position on the platform 114, the outlet 110 is in physical contact
with the absorbent disk 116 (e.g., edges defining the opening of
the outlet 110 touch a top surface of the absorbent disk 116 as
shown in FIG. 5).
[0066] In the example schematically shown in FIG. 5, manually
actuatable component 502 may be coupled to platform 114 in any
suitable way. For example, manually-actuatable component 502 may be
physically connected to platform 114 or otherwise in communication
with platform 114 so that a force applied to manually actuatable
component 502 is transferred or communicated to platform 114 to
move the platform toward outlet 110. Manually actuatable component
502 may at least partially extend outside the body of the DBS
collection device 100 and may take the form of a button, lever,
slider, etc. In some examples, manually-actuatable component 502
may be biased, e.g., via a spring, to remain in the first position
in the absence of actuation or force applied to manually actuatable
component 502. Examples of the manually actuatable component 502
schematically shown in FIG. 5 are described below with reference to
FIGS. 7-15.
[0067] As another example, as shown in FIG. 6, a manually
actuatable component 602 may include a region of the body 102
adjacent to and including the passage 106 such that actuation of
the manually actuatable component 602 causes the passage 106 to
move toward the platform 114 until the outlet 110 is in physical
contact with the absorbent disk 116 on the platform 114. In this
example, manually actuatable component 602 is adjustable between a
first position and a second position relative to the body 102,
wherein, in the first position when an absorbent disk 116 is
mounted in a fixed position on the circular region 118 on the
platform 114, the outlet 110 is not in physical contact with the
absorbent disk (as shown in FIG. 4), and, in the second position
when an absorbent disk 116 is mounted in the fixed position on the
platform 114, the outlet 110 is in physical contact with the
absorbent disk 116 (as shown in FIG. 6).
[0068] In the example shown in FIG. 6, the platform 114 remains in
a fixed position while the passage 106 is moveable relative to body
102 via actuation of manually actuatable component 602. For
example, when a lanced finger is placed onto manually actuatable
component 602 above passage 106 and used to apply a force to the
manually actuatable component 602 in a direction toward platform
114 along the central axis 120 of the passage 106, the passage 106
is moved downward toward platform 114 until the outlet 110 is in
physical contact with absorbent disk 116 mounted on platform 114.
In some examples, manually actuatable component 602 may be biased,
e.g., via a spring, to remain in the first position in the absence
of actuation or force applied to manually actuatable component 602.
Examples of the manually actuatable component 602 schematically
shown in FIG. 6 are described below with reference to FIGS.
16-22.
[0069] The manually actuatable component, e.g., component 502 or
602 described above, may be used to selectively deliver a metered
amount of blood contained in the passage 106 to the absorbent disk
116 for a duration. As remarked above, in some examples, in absence
of actuation or force applied to the manually actuatable component,
the outlet 110 of the passage 106 may not be in physical contact
with the absorbent disk 116, e.g., the outlet 110 may be separated
from the absorbent disk 116 by a non-zero distance. By keeping the
outlet 110 separated from the absorbent disk 116 after transfer of
the blood sample, occurrences of uneven saturation or
oversaturation of the absorbent disk 116 may be reduced. In some
examples, the DBS collection device 100 may include a window
(examples of which are shown in FIGS. 7-10, 19, and 21 and
described below) that allows a user to visually inspect a transfer
of blood from the passage 106 to the absorbent disk 116. For
example, the user may actuate the manually actuatable component so
that the outlet 110 is placed in physical contact with the
absorbent disk 116 to facilitate transfer of a blood sample in the
passage 106 to the absorbent disk 116. Upon visual identification
of saturation of the absorbent disk 116 via the window, the user
may discontinue actuation of the manually actuatable component so
that the outlet 110 is no longer in physical contact with the
absorbent disk 116. Identification of saturation of the absorbent
disk 116 while the manually actuatable component is activated may
be achieved in a variety of ways. For example, instructions may be
provided to a user to maintain actuation of the manually actuatable
component to transfer blood from the passage 106 to the absorbent
disk 116 for a predetermined period of time. As another example,
DBS collection device 100 may include one or more sensors and/or
timers used to detect and or identify sufficient saturation of the
absorbent disk 116. In this example, the DBS collection device 100
may be configured to output a notification, e.g., a visual or audio
notification, to the user to discontinue actuation of the manually
actuatable component in response to a detection or identification
of sufficient saturation of the absorbent disk 116.
[0070] FIG. 7 is a perspective view of another example embodiment
of a DBS collection device 100. Like-numbered elements shown in
FIG. 7 correspond to like-numbered elements shown in FIGS. 1-6 and
described above. The DBS collection device 100 shown in FIG. 7
includes a body 102, having a length 206, width 208, and thickness
210, that forms an "I" shaped device. Coupling elements 202 couple
together the top plate 124 and the bottom plate 126 at regions of
the body 112 which extend outwardly at the corners of the DBS
collection device 100.
[0071] The DBS collection device 100 shown in FIG. 7 includes a
manually actuatable component 502 that includes wings 704 coupled
to opposing sides of platform 114 and extending upward in a
direction along a central axis of passage 106 to partially protrude
out of the top surface 136 of the body 102 at opposing positions
adjacent to inlet 104. The ends of the protruding portions 740 of
the wings 704 of the manually actuatable component 502 are slanted
inwardly toward the inlet 104. The manually actuatable component
502 shown in FIG. 7 is spring-biased via a spring 706 positioned
between the base 708 of the platform 114 and an internal surface
710 in the interior cavity 112 at a bottom portion 744 of the DBS
collection device 100. The spring 706 exerts an upward force on the
platform 114 and wings 704 so that, in a resting position, the
outlet 110 of the passage 106 is in physical contact with an
absorbent disk 116 mounted in a fixed position on a circular region
118 of the platform 114.
[0072] The manually actuatable component 502 is slidably mounted in
the interior cavity 112 of the body 102 via opposing inner walls
750 which interface with outer edges of the wings 704 of the
manually actuatable component 502. In this example, actuation of
the manually actuatable component 502 causes the platform 114 to
move away from the outlet 110 in a direction along the central axis
of the passage 106 so that physical contact between the outlet 110
and the absorbent disk 116 is discontinued, e.g. such that there is
anon-zero distance between the outlet 110 and the absorbent disk
116 when the manually actuatable component 502 is engaged. For
example, a user may place a lanced finger above the inlet 104 to
engage the protruding portions 740 of wings 704. The user may then
exert a downward force onto the protruding portions 740 of wings
704 so that the manually actuatable component 502 is pushed in a
downward direction such that the outlet 110 is not in physical
contact with the absorbent disk 116. The user may continue applying
the downward force to protruding portions 700 of wings 704 until
the lanced finger interfaces with the inlet 104 to transfer blood
from the lanced finger into the passage 106 while the absorbent
disk 116 is not in contact with the outlet 110. The user may
continue transferring blood from the lanced finger to the passage
106 in this way until the passage 116 is sufficiently filled with a
blood sample. As remarked above, in some examples, a diameter and
length of the passage 106 may be sized to contain a predetermined
amount of blood such that, once the passage 106 is filled with the
predetermined amount of blood, no further transfer of blood from
the lanced finger into the passage 106 may occur. After
transferring blood to the passage 106, the user may disengage the
manually actuatable component 502 by discontinuing application of
the downward force applied to the protruding portions 740 of wings
704. In some embodiments, after the user disengages the manually
actuatable component 502, the manually-actuatable component 502
returns to its spring-biased resting position in which the outlet
110 is in physical contact with the absorbent disk 116 so that
blood contained in the passage 106 is transferred to the absorbent
disk 116 to saturate the absorbent disk 116.
[0073] The DBS device 100 shown in FIG. 7 additionally includes a
window 702 which allows a user to visually inspect the absorbent
disk 116 during certain conditions. In this example, the window 702
is formed in a wall of body 102 at a position below the absorbent
disk 116 when the manually actuatable component 502 is in the
resting position, e.g., not actuated. After actuation of the
manually-actuatable component 502 to transfer blood into the
passage 106, the user may disengage the manually actuatable
component 502 so that transfer from the passage 106 to the
absorbent disk 116 occurs while the absorbent disk 116 is out of
view of the window 702. In order to see if the absorbent disk 116
is sufficiently saturated, the user may then re-engage/actuate the
manually actuatable component 502 so that the absorbent disk 116
comes into view via window 702. If, via visual inspection of the
absorbent disk 116 via the window 702, the user determines that the
absorbent disk 116 is not sufficiently saturated with blood, the
user may add an additional amount of blood to the passage 106 for
transfer to the absorbent disk 116 as described above.
[0074] FIGS. 8-13 are various views of another example embodiment
of a DBS collection device 100 having a manually actuatable
component 502. In particular, FIG. 8 is a front perspective view of
DBS collection device 100, FIG. 9 is a back perspective view of DBS
collection device 100, FIG. 10 is a front view of DBS collection
device 100, FIG. 11 is a back view of DBS collection device 100,
FIG. 12 is a side view along a length 206 of body 102, and FIG. 13
is a side view along a width 208 of body 102. Detail views of the
manually actuatable component 502 included in the example device
shown in FIGS. 8-13 are shown in FIGS. 14 and 15. Like-numbered
elements shown in FIGS. 8-15 correspond to like-numbered elements
shown in FIGS. 1-7 and described above.
[0075] The example DBS collection device 100 shown in FIGS. 8-13
includes a body 102 with a top plate 124 and a bottom plate 126
coupled together forming a card-shaped cassette or clamshell device
having a length 206, width 208, and thickness 210. In this example,
the length 206 is greater than the width 208 and the thickness 210
is at least 4 times less than the width 208. For example, the width
208 may be approximately 55 mm, the length 206 may be approximately
78 mm, and the thickness 210 may be approximately 12 mm. The body
102 may include any suitable material. As one non-limiting example,
the top plate 124 and the bottom plate 126 may include a plastic
material and may be coupled together via one or more interlocking
components positioned adjacent to an outer perimeter of the body
102. Though not shown in the figures, DBS collection device 100 may
include a desiccant in the interior cavity 112 of body 102 for
drying out a blood sample during shipping, for example.
[0076] Body 102 of the DBS collection device 100 shown in FIGS.
8-13 defines an inlet 104 of a passage 106 extending from an
exterior of the body 102 to an outlet 110 in an interior cavity 112
of the body 102. In this example, inlet 104 is formed in a raised
region 802 of body 102 at top surface 836. The raised region 802
extends a non-zero distance above the top surface 836. The inlet
104 is positioned at the center of a top surface of the raised
region 802 and edges of the top surface of the raised region 802
are rounded, curving downwardly from the inlet 104 to form an
inverted C-shaped protrusion above top surface 836. The raised
region 802 is included to assist a user in placing a lanced finger
over the inlet 104 in order to transfer blood into the passage
106.
[0077] In this example, the passage 106 includes a capillary tube
822 having a predetermined length and diameter/gauge sized to hold
a predetermined amount of blood, e.g., 3 .mu.L of blood. For
example, the capillary tube 822 may have a length of approximately
11.5 mm, an inner diameter of approximately 0.577 mm, and an outer
diameter of approximately 1.35 mm. A portion of capillary tube 822
is mounted within a tubular orifice 804 formed within the raised
portion 802 beneath the inlet 104. The tubular orifice 804 may be
sized to receive and fixedly hold capillary tube 822 thereby
forming passage 106. In particular, the capillary tube 822 mounted
inside of the tubular orifice 804 may form the passage 106
extending from the inlet 104 to the outlet 110.
[0078] The DBS collection device 100 shown in FIGS. 8-13 includes a
cylindrically-shaped platform 114 coupled to the body 102 within
the interior cavity 112. Platform 114 is positioned directly
beneath outlet 110 of passage 106 so that a central axis of the
passage 106 corresponds to a central axis of the
cylindrically-shaped platform 114. Platform 114 is configured to
hold a specifically-sized absorbent disk 116 in a fixed position on
a circular region 118 on a top surface of platform 114. The top
surface of the platform 114 includes absorbent disk mounting
components 1402 (FIGS. 14 and 15) configured to position and hold
an absorbent disk 116 in a fixed position on the top surface of the
platform 114. In this example, the mounting components 1402 include
small cylindrical protrusions or posts on the top surface of the
platform 114 and are positioned around a circumference of the
absorbent disk 116 to hold the absorbent disk 116 in place with an
interference fit. For example, as shown in FIGS. 14 and 15, the top
surface of the platform 114 may include three protrusions 1402 on
the top surface 1503 of platform 114 positioned around the
circumference of the absorbent disk 116 and spaced on the top
surface 1503 such that the distance between adjacent pairs of
protrusions on the top surface 1503 is substantially the same for
each adjacent pair of protrusions (e.g., the protrusions are evenly
spaced). Though FIGS. 14 and 15 show cylindrical protrusions 1402
positioned around the absorbent disk 116 to hold the absorbent disk
116 in place, it should be understood that any number and any
suitable type of mounting components 1402 may be used to position
and hold the absorbent disk 116 in a fixed position on the top
surface 1503 of the platform 114 without departing from the scope
of the present disclosure.
[0079] As shown in FIGS. 14 and 15, the platform 114 defines a
cylindrical aperture 1551 positioned beneath the absorbent disk 116
and extending through the center of the platform 114 along a
central axis of the platform 114. Additionally, as shown in FIGS.
14 and 15, the top surface 1503 of platform 114 may include smaller
protrusions or posts 1510 positioned between the larger protrusions
1402. The smaller protrusions 1510 may extend above the top surface
1503 of the platform 114 by a distance which is less than the
distance that the larger protrusions 1402 extend above the top
surface 1503 of the platform 114. A bottom surface of the absorbent
disk 116 may be supported by the smaller protrusions 1510 so that
the absorbent disk is positioned a non-zero distance above the top
surface 1503 of the platform 114, thereby permitting air to flow
beneath the absorbent disk 116 and through the cylindrical aperture
1551 to accelerate drying of the absorbent disk 116 after a blood
sample is transferred thereto.
[0080] The DBS collection device 100 shown in FIGS. 8-13 includes a
manually actuatable component 502 coupled to platform 114 such that
actuation of the manually actuatable component 502 causes the
platform 114 to move toward the outlet 110 in a direction along the
central axis of the passage 106 until the absorbent disk 116 on the
platform 114 is in physical contact with the outlet 110 (as shown
in FIGS. 9, 14, and 15 and discussed below). In this example,
manually actuatable component 502 is adjustable between a first
position and a second position relative to the body 102, wherein,
in the first position when an absorbent disk 116 is mounted in a
fixed position on the circular region 118 on the platform 114, the
outlet 110 is not in physical contact with the absorbent disk 116
and, in the second position when an absorbent disk 116 is mounted
in the fixed position on the platform 114, the outlet 110 is in
physical contact with the absorbent disk 116.
[0081] The example manually actuatable component 502 shown in FIGS.
8-15 includes a slidable button 871 (FIG. 8) on an exterior surface
of body 102. The button 871 is coupled to platform 114 via a
coupling element 1502 (FIG. 15) which is affixed to the button 871
adjacent to atop portion of the button 871 and coupled to a bottom
portion of the platform 114. In some embodiments, coupling element
1502 may be disposed between the base of platform 114 and the
backside of the button 817. The coupling element 1502 is shaped and
sized to fit within an elongated aperture 950 in a wall of the body
102 so that the coupling element 1502 is moveable within the
elongated aperture 950 in a direction parallel to a central axis of
the passage 106. Additionally, a tab 902 (FIGS. 9 and 14) is
coupled to a back side of button 871 (at a position below platform
114) and is sized and shaped to be slidable between opposing tracks
904 mounted in the interior cavity 112 below the platform 114 and
oriented in directions parallel to the central axis of the passage
106. A bottom back portion of the platform 114 also includes a tab
906 which is sized to fit between the tracks 904 when the manually
actuatable component 502 is moved in a downward direction away from
the outlet 110.
[0082] In this example, platform 114 is biased via a spring 806
such that, in the absence of actuation or force applied to manually
actuatable component 502, the platform 114 is maintained in a
position wherein the absorbent disk 116 does not touch the outlet
110. Spring 806 extends from an interior surface of raised region
802 to at least partially wrap around the outer surface of the
platform 114 and interfaces with the top surface of coupling
element 1502 so that the spring 806 exerts a downward force on the
platform 114, thereby maintaining anon-zero distance between the
absorbent disk 116 and the outlet 110 in absence of actuation of
the manually actuatable component 502. For example, a user may
place a lanced finger on the raised portion 802 so that a blood
sample is transferred into the passage 106 while the manually
actuatable component 502 is not actuated and thus that the spring
806 biases the outlet 110 away from the absorbent disk 116. Once a
volume of blood is transferred into the passage 106, the user may
apply an upward force to the button 871 in a direction parallel to
the central axis of the passage 106 and towards the inlet 104 until
the absorbent disk 116 physically touches the outlet 110. The user
may then maintain the applied force on the button 871 so that the
contact between the absorbent disk 116 and the outlet 110 is
maintained to facilitate transfer of blood from the passage 106 to
the absorbent disk 116. Once a sufficient amount of blood is
transferred from the passage 106 to the absorbent disk 116, the
user may release the force applied to the button 871 so that the
outlet 110 is again separated from the absorbent disk 116.
[0083] DBS collection device 100 shown in FIGS. 8-13 additionally
includes a window 702 which allows a user to visually inspect a
transfer of blood from the passage 106 to the absorbent disk 116
while engaging the manually actuatable component 502. In this
example, the window 702 includes a transparent portion of a wall of
the body 102 at a corner 880 of the body 102 adjacent to the inlet
104. For example, the window 702 may be composed of a substantially
transparent plastic material which is inserted into a cutout in the
wall of the body 102 adjacent to corner 880. The transparent window
702 may be mounted in the cutout in the wall of body 102 such that
the transparent window 702 may be unsnapped and removed at a lab,
for example. After removal of the window 702, the component
comprising the platform 114 and the manually actuatable component
502 may be removed from body 102 so that the absorbent disk 116 can
be accessed for testing. This removable component comprising the
platform 114 and the manually actuatable component 502 may provide
a laboratory technician with a conveniently-sized part for
handling, and, in some examples, may include bar code information
or other indicia which may be inspected or scanned at the lab.
[0084] DBS collection device 100 shown in FIGS. 8-13 also includes
a lancet system 418 (FIG. 9). Lancet system 418 includes a lancet
420 having a needle 422 extending from a body of the lancet, a
lancet actuation component 426, a lancet depth adjustment component
424, and a lancet port 462 formed as an opening in an outer wall of
body 102. Lancet 420 is slidably mounted in the interior cavity 112
of body 102 and is in communication with the lancet actuation
component 426 such that when the lancet actuation component 426 is
actuated, a portion of the needle 422 is projected out through the
lancet port 462.
[0085] In the non-limiting example shown in FIGS. 8-13, the lancet
system 418 includes a biasing spring 458 positioned between a base
951 of lancet 420 and a spring base component 456 mounted within
the interior cavity 112 of body 102. The lancet 420 is held in a
trigger-ready position within the interior cavity 112 by a latch
454 coupled to the lancet actuation component 426. In the
trigger-ready position, the biasing spring 458 is compressed
between the lancet 420 and the spring base component 456 to confer
a potential energy to the biasing spring 458. This potential energy
may be released in response to removal of the latch 454. Actuation
of the lancet actuation component 426 may release the latch 454
from the lancet 420 thereby permitting the biasing spring 458 to
propel the lancet 420 so that the needle 422 of the lancet 420
protrudes out of the lancet port 462 by a predetermined distance.
Actuation of the lancet actuation component 426 by removal of the
latch 454 is discussed in further detail below.
[0086] In the non-limiting example shown in shown in FIGS. 8-13,
the lancet actuation component 426 includes a lever having a
fulcrum 812 dividing the lever into a first region 810 and a second
region 808. The fulcrum 812 may include a rod 933 (FIG. 9) coupled
to an underside of the lancet actuation component 426 in the
interior cavity 112. Ends of the rod 933 may be pivotally mounted
in supports 937 coupled to an internal wall in the interior cavity
112 of the body 102. The lever may be composed of any suitable
material, e.g., plastic, and may have any suitable dimensions. In
one example, as shown in FIG. 10, the lever has a width 953 which
is at least two times less than a length 955 of the lever. Further,
in this example, the width 953 of the lever is greater than a
thickness 961 (FIG. 8) of the lever, e.g., the width 953 may be at
least 5 times greater than the thickness 961, to form a thin, flat,
pivotable actuating component which is at least partially rotatable
about the fulcrum 812. In this non-limiting example, a length 957
of the first region 810 is greater than a length 959 of the second
region 808. A distal end 870 of the second region 808 has rounded
edges so that the outer surface at the distal end 870 of the second
region 808 forms a half-circle shape (as shown in FIGS. 8 and 10).
An underside of the second region 808 includes a latch 454 at the
distal end 870 which engages the lancet 420 to hold the lancet 420
in a trigger-ready position wherein the spring 458 is compressed.
Prior to actuation of the lancet actuation component 426 while the
latch 454 is engaged with the lancet 420, the first region 810 may
be recessed within an aperture 1004 (FIG. 10) in body 102 so that
the outer surface of the first region 810 is in substantially the
same plane as the outer surface of the body 102 adjacent to the
first region 810. The first region 810 is moveable into the
interior cavity 112 of the body 102 via aperture 1004. The outer
surface of the second region 808 may be positioned above a plane of
the outer surface of body 102 adjacent to the second region 808 so
that the second region 808 protrudes above a surface of the body
102 as shown in FIG. 12. First region 810 may additionally include
a guiding element 1002 (FIG. 10) on the outer surface near a distal
end of the first region 810. Guiding element 1002 may include a
mark, e.g., a circular mark, or indentation for indicating a
location to apply force to actuate the lancet 420.
[0087] The lancet 420 is slidably mounted within two opposing
tracks 470 coupled to an inner wall of the body 102 in the interior
cavity 112 such that the lancet 420 is moveable within the interior
cavity 112 between a first position where the lancet needle 422 is
fully contained within the interior cavity 112 and a second
position where a length of the needle 422 extends outside of the
lancet port 462. The length of the portion of the needle 422
projected out of the lancet port 462 may be adjusted via a manual
adjustment of the lancet depth adjustment component 424. In this
non-limiting example, the lancet depth adjustment component 424
includes a slider positioned on the top surface 836 of body 102. A
plurality of raised elements, or treads, is formed on the top
surface of the slider. The raised portions on the top surface of
the slider may increase the coefficient of friction when a user
applies a lateral force to the top surface of the slider to move
the slider in a direction parallel to top surface 836. The slider
is coupled to a blocking element 450 through an elongated aperture
1211 (FIG. 12) in the top surface 836. For example, a user may
apply a lateral force to the slider to move a portion of the
blocking element 450 into a path of the top surface 480 of lancet
420 in order to decrease a depth of penetration of the lancet
needle 422.
[0088] In the non-limiting example of the DBS collection device 100
shown in FIGS. 8-13, the lancet depth adjustment component 424
additionally includes a tab 814 (FIG. 8) coupled to a side of the
lancet depth adjustment component 424 near the center of the lancet
depth adjustment component 424. The tab 814 may have edges
extending downwardly from the top surface 836 that taper to a
pointed end. Indicia 440 may be included on an outer surface of
body 102 at a position beneath the pointed end of tab 814. The
indicia 440 may include markings or labels which indicate different
lancet depths corresponding to different positions of the lancet
depth adjustment component 424. For example, when the lancet depth
adjustment component 424 is in a first position, the pointed end of
tab 814 on lancet depth adjustment component 424 may be directly
above a first depth marking corresponding to a first length that
the lancet needle 422 would protrude out of lancet port 462 upon
actuation of the lancet 420; when the lancet depth adjustment
component 424 is in a second position, the pointed end of tab 814
on lancet depth adjustment component 424 may be directly above a
second depth marking corresponding to a second different length
that the lancet needle 422 would protrude out of lancet port 462
upon actuation of the lancet 420.
[0089] In the non-limiting example of the DBS collection device 100
shown in FIGS. 8-13, the lancet system 418 is a single-use lancet
system such that, after an initial actuation of the lancet 420
which causes the needle 422 to protrude out of the lancet port 462,
the needle 422 automatically retracts back into the interior cavity
112 and stays in the interior cavity 112 during subsequent lancet
actuation attempts following the initial actuation. For example, in
order to actuate the lancet 420, the user may apply a force to the
first region 810 of the lancet actuation component 426 in a
direction toward the interior cavity 112 of the body 102. Such a
force would cause the lever to rotate about the fulcrum 812 so that
the latch 454 at the distal end 870 of the second region 808 of the
lancet actuation component 426 is disengaged from the lancet 420,
thereby permitting the (spring biased) lancet 420 to move toward
the lancet port 462 so that a portion of the needle 422 extends out
of the lancet port. The latch 454 may be coupled to lancet 420 by a
set of hooks on each part (not shown). When DBS collection device
100 is assembled, the lancet 420 may be placed such that it loads
compression spring 458 and is then retained in a compressed
position by the hook on latch 454. The hook on latch 454 may
release the lancet 420 when lancet actuation component 426 is
pushed (and the breakable component 452 is broken or yields), and
compression spring 458 may then push lancet 420 forward. In this
example, the lancet 420 includes two opposing wings 991 (FIG. 9)
coupled to opposing sides of the lancet 420 and in contact with
opposing tracks 470 when the lancet 420 is launched toward the
lancet port 462. The opposing wings 991 each include flared ends
993 which are curved/bent outwardly away from a central axis of the
needle 422 adjacent to an end of the lancet 420 opposite from
needle 422. After the lancet 420 is launched (via the spring 458)
toward the lancet port 462 following disengagement of latch 454,
the lancet 420 moves toward the lancet port 462 until the flared
ends 993 come into contact with tracks 470. The flared ends 993 may
hold the lancet 420 in place. A counter-biasing spring (like the
counter-biasing spring 460 of FIG. 2), weaker than compression
spring 458, then creates a counter-biasing force when the lancet
420 is launched forward and reaches a "hard stop"; the
counter-biasing spring "pushes" the lancet 420 back some small
distance until the counter-biasing spring and the compression
spring 458 equilibrate. This causes the lancet 420 to retract back
into the interior cavity 112 after the needle 422 briefly protrudes
from the lancet port 462 so that the tip of the needle 422 does not
protrude from the DBS collection device 100. In this example, after
actuation and retraction of the lancet 420, the location of the
lancet 420 in the interior cavity 112 is such that the needle 422
is fully contained within the interior cavity 112 but at a location
which is different from the location of the lancet 420 in the
trigger-ready state. As such, the latch 454 may not engage the
lancet 420 after an initial actuation and the lancet 420 may not
again be actuated.
[0090] FIGS. 16-21 show various views of another example embodiment
of a DBS collection device 100 having a manually actuatable
component 602. In particular, FIG. 16 is a front perspective view
of DBS collection device 100, FIG. 17 is a front view of DBS
collection device 100, FIG. 18 is another front perspective view of
DBS collection device 100, FIG. 19 is a back view of DBS collection
device 100, FIG. 20 is a side view of DBS collection device 100,
and FIG. 21 is a back view of DBS collection device 100 with
internal components exposed. Like-numbered elements shown in FIGS.
16-21 correspond to like-numbered elements shown in FIGS. 1-15 and
described above.
[0091] The example DBS collection device 100 shown in FIGS. 16-21
includes a body 102 having a length 206, width 208, and thickness
210. In this example, the length 206 is greater than the width 208
and the thickness 210 is at least 4 times the width 208. As a
non-limiting example, the length 206 may be approximately 65 mm,
the width 208 may be approximately 55 mm, and the thickness 210 may
be approximately 6 mm. The body 102 may include any suitable
material or combination of materials. As one non-limiting example,
the body 102 may be composed of a plurality of plastic components
coupled together to form a housing which includes various
components, examples of which are described below. One or more
contours may be formed in body 102 to provide a user feedback for
finger placement while using the DBS collection device 100. In this
example, a side 1626 of the body includes an indented region 1606
in which a width of the body 102 in the indented region 1606 is
less than the width 208 of the body at sides 1624 and 1628, thereby
forming an indented profile when viewed from a top surface 1620. A
lancet port 462 is positioned in the indented region 1606 at a
location in side 1626 wherein the width of the body 102 is at a
minimum. The indented region 1606 may assist a user in holding the
body 102 and positioning a finger over lancet port 462.
[0092] Body 102 of the DBS collection device 100 shown in FIGS.
16-21 defines an inlet 104 of a passage 106 extending from an
exterior of the body 102 to an outlet 110 in an interior cavity 112
of the body 102. In this example, passage 106 includes a capillary
passage. However, it should be understood that any suitable passage
or orifice may be used without departing from the scope. For
example, as shown in FIG. 22 described below, passage 106 may
include a screened orifice.
[0093] In this example, inlet 104 is formed in a manually
actuatable component 602 positioned in an aperture 1602 in the top
surface 1620 of the body. The manually actuatable component 602
takes the form of a funnel having inwardly slanted walls 2010 (FIG.
20) which slope inwardly from top surface 1620 toward the interior
cavity 112 and terminate at the inlet 104 of passage 106. The top
surface 1620 additionally includes a channel 1604 recessed in the
top surface 1620 forming an indented contour on an elongated region
of the top surface 1620. The channel 1604 includes a recessed
region of the top surface 1620 having a width 1652 and a length
1654. The channel 1604 extends from side 1624 toward the opposing
side 1628 and terminates in a rounded region 1656 at a position on
top surface 1620 offset by a non-zero distance from side 1628.
Manually actuatable component 602 is positioned within aperture
1602 in the channel 1604 adjacent to the rounded region 1656. The
channel 1604 may assist in guiding finger placement into the funnel
and directing blood from a lanced finger positioned in or near the
funnel into the inlet 104.
[0094] In the example shown in FIGS. 16-21, the passage 106 is
formed by walls 2010 (FIG. 20) of the manually actuatable component
602 beneath the inlet 104 and opens into the interior cavity 112
via the outlet 110. The passage 106 may have a predetermined length
and predetermined diameter or gauge that are sized to meter the
amount of blood delivered to the absorbent disk 116. In this
example, DBS collection device 100 includes a disk-shaped platform
114 coupled to the body 102 within the interior cavity 112. The
platform 114 is positioned directly beneath outlet 110 of passage
106 so that a central axis of the passage 106 corresponds to a
central axis of the platform 114. In this example, the platform 114
includes an absorbent and/or porous material which is in physical
contact with a bottom surface of the (primary) absorbent disk 116.
The secondary absorbent or porous material may be a porous polymer
material, absorbent paper, or any other suitable absorbent or
porous material which functions to absorb excess blood that is not
absorbed by the absorbent disk 116. The secondary absorbent
material may have any suitable physical dimensions, properties, or
characteristics, e.g., average pore size, porosity, shape, volume,
surface area, etc., selected to provide a balance of relative
capillary forces between the absorbent disk 116 and the absorbent
platform 114 such that blood in excess of a predetermined absorbent
disk saturation volume is drawn from the absorbent disk 116 into
the secondary absorbent material. For example, an average pore size
of the secondary absorbent material may be greater than an average
pore size of the absorbent disk 116. Such an approach operates on a
self-regulating principle that uses the balance of relative
capillary forces between interacting materials to achieve a
consistency of blood volume in the absorbent disk 116. The balance
may be achieved through careful selection of materials and their
capillary properties, for example. In particular, when blood is
introduced to the top of absorbent disk 116 via inlet 104, it may
wick into the absorbent disk 116 via capillary forces presented by
the internal structure of the absorbent disk 116. Excessive amounts
of blood, e.g., a larger volume of blood than the absorbent disk
116 is capable of absorbing, may be presented to the top surface of
the absorbent disk 116. On its own, the absorbent disk 116 may tend
to oversaturate with blood and leave a residue of extra blood on
its top surface. However, with the secondary absorbent material
present on the other side of the absorbent disk 116, a capillary
pressure may be created between the secondary absorbent material
and the absorbent disk 116. The secondary absorbent material may
have physical properties or characteristics selected to provide a
capillary pressure between the absorbent disk 116 and the secondary
absorbent material that is too weak, e.g., a capillary pressure
which is less than an upper capillary pressure threshold, to wick
correctly-saturated blood from the absorbent disk 116 so that the
volume of blood in the absorbent disk 116 remains greater than a
lower specification limit for testing. Concurrently, the secondary
absorbent material may provide a capillary pressure between the
absorbent disk 116 and the secondary absorbent material which is
strong enough, e.g., a capillary pressure which is greater than a
lower capillary pressure threshold, to wick excessive blood from
the absorbent disk 116 so that the volume of blood remaining in the
absorbent disk 116 is less than an upper specification limit for
testing. As a non-limiting example, the absorbent disk 116 may
include a 3 mm diameter GE DMPK-A paper dot (manufactured by GE
Healthcare BioSciences Corp. of Piscataway, N.J.) resting on top of
an absorbent material comprising a 7 mm diameter, 1.6 mm thick
POREX disc (manufactured by Porex Corp., Fairburn, Ga.). For
example, the disc may include a POREX X-4899 Polyethylene sheet
with a pore size of approximately 50 to 90 microns.
[0095] As a non-limiting example, the platform 114 may include an
absorbent and/or porous disk composed of an absorbent and/or porous
material having a diameter greater than the diameter of the
absorbent disk 116. In some examples, the diameter of the platform
114 may be at least twice as large as the diameter of the absorbent
disk 116. However, in other examples, the secondary absorbent
material of the platform 114 may have substantially the same size,
e.g., may have substantially the same diameter, as the absorbent
disk 116. In still other examples, the secondary absorbent material
of the platform 114 may be smaller than, e.g., have a diameter less
than, the absorbent disk 116. For example, a diameter of the
secondary absorbent material may be approximately the same as the
diameter of the passage 106 but may be less than the diameter of
the absorbent disk 116. Further, in some examples, the secondary
absorbent material may have a different shape than the absorbent
disk 116.
[0096] In the illustrated embodiment, the platform 114 is mounted
in a releasable cartridge 1802 (FIG. 18) having a front outwardly
facing end 1852 coupled to two opposing tracks 1850 which are
slidably mounted in the internal cavity 112 of body 102. The tracks
1850 form an oval-shaped aperture 1806 in a bottom side of the
releasable cartridge 1802. In particular, when viewed from top
surface 1620, the two opposing ends of aperture 1806 have
half-circle shapes which open into the center of the aperture 1806
(as shown in FIG. 18). The platform 114 may be mounted in the inner
half-circle shaped end of aperture 1806. For example, a diameter of
the inner half-circle shaped end of aperture 1806 may be
approximately the same as the diameter of the platform 114.
Absorbent disk mounting components 1402 are coupled to the tracks
1850 to hold the absorbent disk 116 in place at the center of the
top surface of platform 114, e.g., a center of the absorbent disk
116 may be directly aligned with a center of the platform 114. The
mounting components 1402 may include opposing tabs mounted on
opposing tracks 1850 and extending over the top surface of platform
114 to terminate at opposing concave arc-shaped ends which
interface with opposing sides of the absorbent disk 116 to hold the
absorbent disk 116 in a fixed position on the top surface of
platform 114 via an interference fit.
[0097] The releasable cartridge 1802 is slidable between a first
position, wherein the cartridge 1802 is inside internal cavity 112
and the front end 1852 is substantially flush with the outer
surface of side 1628, and a second position (shown in FIG. 18)
wherein the releasable cartridge 1802 extends outside of the
interior cavity 112. In the first position, releasable cartridge
1802 positions the absorbent disk 116 mounted on platform 114
directly below the outlet 110 (FIG. 20). The releasable cartridge
1802 may include a locking mechanism 1804, e.g., a tab or snap
feature, which interfaces with an internal component to hold the
releasable cartridge 1802 in the first position. In order to unlock
the releasable cartridge 1802, a user may insert a suitable tool
into an aperture 1902 (shown in FIG. 19) positioned in a bottom
surface 2030 of body 102 to move or unsnap the locking mechanism
1804 so that the releasable cartridge 1802 is free to be slid out
of the interior cavity 112 into the second position. For example, a
laboratory technician may unlock the releasable cartridge 1802 via
aperture 1902 in order to remove releasable cartridge 1802 from DBS
collection device 100 to gain access to the absorbent disk 116 for
processing. In some examples, a traction element 2195, e.g., an
indentation or the like, may be included on a bottom portion of
releasable cartridge 1802 to assist a user in gripping the
cartridge 1802 to remove the cartridge 1802. In some examples, the
releasable cartridge 1802 may include indicia, e.g., markings,
labels, bar codes, etc. which may be inspected or scanned by a
laboratory technician.
[0098] In the example shown in FIGS. 16-21, while the releasable
cartridge 1802 is locked in the first position within interior
cavity 112, the platform 114 remains in a fixed position whereas
the passage 106 is moveable relative to body 102 via actuation of
manually actuatable component 602. The manually actuatable
component 602 includes opposing internal braces 2022 (FIG. 20)
extending from opposing sides of the funnel in the interior cavity
112 that interface with spring components 2024. For example, spring
components 2024 may include cantilever springs mounted to a bottom
interior surface of body 102, e.g., the spring components 2024 may
be formed with a pass core when the bottom interior surface is
molded. The spring components 2024 exert an upward force to the
opposing internal braces 2022 so that, in the absence of actuation
or force applied to manually actuatable component 602, the
manually-actuatable component 602 is maintained in a lifted
position wherein the outlet 110 does not physically touch the
absorbent disk 116.
[0099] For example, when a lanced finger is placed onto manually
actuatable component 602 above passage 106 and used to apply a
downward force to the manually actuatable component 602 in a
direction toward platform 114 along the central axis of the passage
106, the passage 106 is moved downward toward platform 114 until
the outlet 110 is in physical contact with absorbent disk 116
mounted on platform 114. In this position, the inlet 104 may
provide initial capillary action to help draw the blood to the
absorbent disk 116 while the outlet 110 is in contact with the
absorbent disk 116. Once a blood sample has been transferred to the
absorbent disk 116, the lanced finger may be released from the
manually actuatable component 602 thereby separating the absorbent
disk 116 and the outlet 110.
[0100] The DBS collection device 100 shown in FIGS. 16-21
additionally includes a window 702 (FIG. 19) which, in this
example, is positioned in the bottom surface 2030 of body 102
directly below the disk-shaped platform 114, thereby allowing a
user to visually inspect a bottom surface of platform 114. In some
embodiments, the platform 114 may be transparent to allow a visual
inspection of blood absorbed by the platform 114. The window 702
may be composed of a substantially transparent plastic material
which is inserted into a cutout in the bottom surface 2030 of body
102. The DBS collection device 100 shown in FIGS. 16-21
additionally includes a desiccant pad 412 mounted to an interior
wall in interior cavity 112 via one or more mounting components
2197 (FIG. 21) to assist in drying blood transferred to the
absorbent disk 116 and to maintain a reduced humidity level inside
the DBS collection device 100. As discussed above, desiccant pad
412 may include any suitable hygroscopic substance that induces or
sustains a state of dryness.
[0101] DBS collection device 100 shown in FIGS. 16-21 includes a
lancet system 418 (FIG. 21). Lancet system 418 includes a lancet
420 having a needle 422 extending from a body of the lancet 420, a
lancet actuation component 426, a lancet depth adjustment component
424, and a lancet port 462 formed as an opening in an outer wall of
body 102. Lancet 420 is slidably mounted in the interior cavity 112
of body 102 and in communication with the lancet actuation
component 426 such that when the lancet actuation component 426 is
actuated, a portion of the needle 422 is projected out through the
lancet port 462. In this non-limiting example, the lancet system
418 includes a biasing spring 458 positioned between a base portion
of lancet 420 and a base component 456 affixed within the interior
cavity 112 of body 102.
[0102] The lancet 420 is held in a trigger-ready position within
the interior cavity 112 by a latch 454 (FIG. 21) coupled to the
lancet actuation component 426. Latch 454 interfaces with a tab
2110 extending from a bottom portion of the lancet 420. In the
trigger-ready position, the biasing spring 458 is compressed
between the lancet 420 and the base component 456 to confer a
potential energy to the spring which may be released in response to
disengagement of the latch 454 with tab 2110. Actuation of the
lancet actuation component 426 may release the latch 454 from tab
2110, thereby permitting the biasing spring 458 to propel the
lancet 420 so that the needle 422 of the lancet 420 protrudes out
of the lancet port 462 by a predetermined distance.
[0103] In this non-limiting example, the lancet actuation component
426 includes a button 2112 having a first extension 2114 and a
second extension 2116 extending therefrom into the interior cavity
112 of the body 102. The first extension 2114 and the second
extension 2116 are parallel and slidably mounted within opposing
tracks 2118. A distal end of the first extension 2114 includes
latch 454 which interfaces with tab 2110 on lancet 420 to hold the
lancet 420 in a trigger-ready position. A distal end of the second
extension 2116 includes a tab 2220 perpendicular to the second
extension 2116. Tab 2220 is positioned between an end 2222 of one
of the tracks 2118 in the interior cavity 112 and a blocking
component 2221 mounted in the interior cavity. When the lancet 420
is in the trigger-ready position with the latch 454 engaging the
tab 2110, the tab 2220 may physically touch end 2222 so that the
tab 2220 cannot move in an outward direction from the internal
cavity 112 beyond end 2222. When actuated, the tab 2220 may move
toward blocking component 2221 and blocking component 2221 may
prevent movement of the tab 2220 beyond the blocking component
2221, thereby limiting a range of movement of the lancet actuation
component 426.
[0104] The lancet 420 is slidably mounted within two opposing
tracks 470 mounted on an inner wall of the body 102 in the interior
cavity 112 such that the lancet 420 is moveable within the interior
cavity 112 between a first position where the needle 422 is fully
contained within the interior cavity 112 and a second position
where a length of the needle 422 extends outside of the lancet port
462. The length of the portion of the needle 422 projected out of
the lancet port 462 may be adjusted via a manual adjustment of the
lancet depth adjustment component 424. In this non-limiting
example, the lancet depth adjustment component 424 includes a
slider positioned on side 1622 of body 102. The slider is coupled
to a blocking element 450 (FIG. 21) through an elongated aperture
1211 in the side 1622. The blocking element 450 may be supported by
a track 2196 which is parallel to a bottom surface of blocking
element 450. For example, a user may apply a lateral force to the
slider to move a portion of the blocking element 450 into a path of
the top surface 480 of lancet 420 in order to decrease a depth of
penetration of the needle 422.
[0105] In the non-limiting example DBS collection device 100 shown
in FIGS. 16-21, the lancet depth adjustment component 424
additionally includes a tab 814 (FIG. 16) coupled to a side 1691 of
the lancet depth adjustment component 424 near the center of the
lancet depth adjustment component 424. The tab 814 may have edges
extending toward indicia 440 included on the top surface 1620.
Indicia 440 may be included on an outer surface of body 102 at a
position beneath the pointed end of tab 814. The indicia 440 may
include markings or labels which indicate a different lancet depths
corresponding to different positions of the lancet depth adjustment
component 424.
[0106] In the non-limiting example DBS collection device 100 shown
in FIGS. 16-21, the lancet system 418 is a single-use lancet
system, such that, after an initial actuation of the lancet 420
which causes the needle 422 to protrude out of the lancet port 462,
the needle 422 automatically retracts back into the interior cavity
112 and stays in the interior cavity 112 during subsequent lancet
actuation attempts following the initial actuation. In this
example, the lancet system 418 includes a counter-biasing spring
460 (FIG. 21) which interfaces with the lancet 420 to retract the
needle 422 after actuation of the lancet 420. For example, a first
end of the counter-biasing spring 460 may be in contact with top
surface 180 of lancet 420 and a second end of the counter-biasing
spring 460, opposite the first end, may be in contact with an inner
surface of body 102 adjacent to the lancet port 462 and may be held
in position by a blocking element 2130 coupled to the inner surface
adjacent to the lancet port 462. The counter-biasing spring 460 may
supply a counter-biasing force to the lancet 420 in a direction
along a central axis of the needle 422 away from the lancet port
462. The counter-biasing force provided by the counter-biasing
spring 460 may be less than the biasing force provided by the
biasing spring 458. For example, the spring constant of the
counter-biasing spring 460 relative to the spring constant of the
biasing spring 458 may be such that when the counter-biasing spring
460 and the biasing spring 458 are in equilibrium, the lancet 420
is at a position in the interior cavity 112 where the needle 422 of
the lancet 420 does not protrude out of the lancet port 462.
[0107] In the example shown in FIGS. 16-21, the lancet actuation
component 426 includes a breakable component 452 (FIG. 21) which
breaks or degrades following an initial actuation of the lancet 420
so that the lancet actuation component 426 is no longer functional
following the initial actuation. In this example, the breakable
component 452 is coupled perpendicularly between the first
extension 2114 and the second extension 2116 in the internal cavity
112. A width of the breakable component 452 tapers from the first
and second extensions to a minimum width at the center 2180 of the
breakable component 452 thereby forming an hour-glass shape. A
spike 2182 is mounted within the interior cavity 112 between the
first extension 2114 and the second extension 2116 and beneath the
thin center 2180 of the breakable component 452. In this example,
spike 2182 has a pointed end 2119 which is positioned directly
beneath the thin center 2180 of the breakable component 452 when
the lancet 420 is in the trigger-ready position with the latch 454
engaged with the tab 2110. In order to actuate the lancet 420, the
user may apply an inward force to button 2112 to cause the first
and second extensions 2114 and 2116 to move toward the lancet port
462 in a direction parallel to a central axis of the needle 422.
This movement may cause the thin center 2180 of the breakable
component 452 to break as it is pushed into the pointed end 2119 of
spike 2182. In particular, when the breakable component 452 breaks,
the lancet 420 cannot retract to a spring-loaded configuration;
even if the lancet 420 were able to return to its original
position, no component would retain it in place. During initial
actuation, the inward force applied to the lancet actuation
component 426 when a user presses the button 2112 would cause the
latch 454 to be forced against a sloping component 2190 away from
tab 2110 so that the latch disengages the tab 2110, thereby
permitting the compressed spring 458 to launch the lancet 420
toward the lancet port 462 so that the needle 422 protrudes a
predetermined distance outside of the lancet port 462. The
counter-biasing spring 460 may then exert a counter force to
retract the lancet 420 back into the interior cavity 112 so that
the needle 422 is again fully contained in the interior cavity
112.
[0108] FIG. 22 is a cross-sectional view of another example DBS
collection device 100. The example DBS collection device 100 shown
in FIG. 22 is similar to the example device shown in FIGS. 16-21
and described above, except that the passage 106 includes a
screened orifice 2202. The screened orifice 2202 may include any
suitable material, e.g., plastic stainless steel, etc., and may be
formed in any suitable way. For example, the screen of the screened
orifice 2202 may be a woven mesh or a photo-etched blank that can
be stamped at predetermined dimensions. Screened orifice 2202 may
include a plurality of passages, where each passage in the
plurality of passages includes an inlet opening to an exterior of
body 102 and an outlet opening into the interior cavity 112 of the
body 102. As in the example device shown in FIGS. 16-21, in the
example of FIG. 22, the screened orifice 2202 is maintained
disconnected from the absorbent disk 116 until a downward force is
applied to the manually actuatable component 602. Such an approach
may provide an increased surface wicking area and allow for more
room for error in placement of a lanced finger at the inlet while
maintaining no skin contact with the absorbent disk 116 during
sample transfer to the disk.
[0109] FIG. 23 illustrates another example of a dried blood spot
collection device, in accordance with various embodiments. The DBS
collection device 100 shown in FIG. 23 includes a manually
actuatable component 502 that includes or is coupled to the
platform 114 such that the manually actuatable component 502 causes
the platform 114 to move toward the outlet 110 until the absorbent
disk 116 on the platform 114 is in physical contact with the outlet
110. In this example, the manually actuatable component further
includes an extension 2302 that engages a switch 2304 on a printed
circuit assembly 2306. The printed circuit assembly 2306 may be
populated such that triggering of the switch 2304 by the extension
2302 captures the time and date at which the sample was taken.
[0110] In the illustrated example, the DBS collection device 100
includes a compression spring 2308 that traverses the space between
the platform 114 and a stopper 2310 that surrounds the capillary
tube 822. The compression spring 2308 returns the manually
actuatable component 502 to its original position and disengages
the outlet 110 from the absorbent disk 116.
[0111] It is to be understood that the configurations and/or
approaches described herein are exemplary in nature, and that these
specific embodiments or examples are not to be considered in a
limiting sense, because numerous variations are possible. The
specific routines or methods described herein may represent one or
more of any number of processing strategies. As such, various acts
illustrated may be performed in the sequence illustrated, in other
sequences, in parallel, or in some cases omitted. Likewise, the
order of the above-described processes may be changed.
[0112] The subject matter of the present disclosure includes all
novel and nonobvious combinations and subcombinations of the
various processes, systems and configurations, and other features,
functions, acts, and/or properties disclosed herein, as well as any
and all equivalents thereof. For example, embodiments of manually
actuable components in which a platform moves toward an outlet of a
passage may be combined with embodiments in which a passage moves
toward a platform such that both mechanisms are included in a
single device.
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