U.S. patent application number 17/142041 was filed with the patent office on 2021-04-29 for sampling assembly.
The applicant listed for this patent is ATOMO DIAGNOSTICS PTY LIMITED. Invention is credited to Johannes BEHRISCH, Ernesto Monis HUESO, Ian Fredrick JOHNSON, John KELLY, Kamman LAW, Melody SHIUE, Eric SIU, Richard SOKOLOV.
Application Number | 20210121110 17/142041 |
Document ID | / |
Family ID | 1000005326521 |
Filed Date | 2021-04-29 |
United States Patent
Application |
20210121110 |
Kind Code |
A1 |
KELLY; John ; et
al. |
April 29, 2021 |
SAMPLING ASSEMBLY
Abstract
An assembly for sampling bodily fluid, the assembly comprising a
membrane penetration device comprising a membrane penetrating
element for penetrating a bodily membrane to release a bodily
fluid; and, a collector configured in a collection position to take
up the released bodily fluid and retain the fluid for delivery to a
test element.
Inventors: |
KELLY; John; (Newington,
AU) ; SOKOLOV; Richard; (Newington, AU) ;
JOHNSON; Ian Fredrick; (Newington, AU) ; HUESO;
Ernesto Monis; (Newington, AU) ; SIU; Eric;
(Newington, AU) ; SHIUE; Melody; (Newington,
AU) ; LAW; Kamman; (Newington, AU) ; BEHRISCH;
Johannes; (Newington, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ATOMO DIAGNOSTICS PTY LIMITED |
Drummoyne |
|
AU |
|
|
Family ID: |
1000005326521 |
Appl. No.: |
17/142041 |
Filed: |
January 5, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14180751 |
Feb 14, 2014 |
10881342 |
|
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17142041 |
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13879297 |
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PCT/AU2011/001321 |
Oct 17, 2011 |
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14180751 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150717 20130101;
A61B 5/150618 20130101; A61B 5/15117 20130101; A61B 5/150022
20130101; A61B 5/150503 20130101; A61B 5/150412 20130101; A61B
5/157 20130101; A61B 5/150549 20130101; A61B 5/150213 20130101;
A61B 5/15113 20130101; A61B 5/150358 20130101; A61B 5/1519
20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/151 20060101 A61B005/151; A61B 5/157 20060101
A61B005/157 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 15, 2010 |
AU |
2010904615 |
Claims
1.-21. (canceled)
22. A single use assembly for sampling bodily fluid, the assembly
comprising an support member; and a collector reservoir positioned
on the support member, the collector reservoir being configured to
adopt a collection position to allow the collector reservoir to
take up and store a sample of bodily fluid, and a delivery position
to deliver the stored sample from the collector reservoir to a test
element, the collector reservoir having a predefined sample volume,
wherein the collector reservoir is not in fluid communication with
the test element in the collection position; and wherein the
collector reservoir is configured to move between the collection
position and the delivery position by movement of the support
member.
23. The assembly according to claim 22, wherein the collector
reservoir is adapted in the delivery position to deliver the sample
to a specific, predefined position on the test element.
24. The assembly according claim 22, wherein the collector
reservoir is operatively adapted to move from the collection
position to the delivery position by one or more of pivoting,
sliding, rotating and translating.
25. The assembly according to claim 22, wherein the collector
reservoir is configured to take up the sample of released bodily
fluid by capillary action.
26. The assembly according to claim 23, wherein the collector
reservoir comprises a tube including a ventilation aperture.
27. The assembly according to claim 24, wherein the tube includes a
collection opening and a discharge opening, and the ventilation
aperture is a longitudinal slot extending from the collection
opening to the discharge opening.
28. The assembly according to claim 22 wherein the collector
reservoir is inhibited from moving into the delivery position by a
locking mechanism until after an element has been actuated.
29. The assembly according to claim 22, further including a
retainer adapted to retain the collector reservoir.
30. The assembly according to claim 29, wherein the retainer is
selected from the group consisting of a clip engaged with the
assembly, a pivotable engagement, and a cavity.
31. The assembly according to claim 22, wherein the assembly
further includes an internal storage for a solution and an actuator
adapted to release the solution from the internal storage to the
test element.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
13/879,297 filed on Apr. 12, 2013, entitled "SAMPLING ASSEMBLY,"
which is a 371 National Stage of International Application No.
PCT/AU2011/001321, filed on Oct. 17, 2011, entitled "SAMPLING
ASSEMBLY," which claims priority to International Australian
Application No. 2010904615, filed on Oct. 15, 2010, entitled
"SAMPLING ASSEMBLY," the entireties of which are hereby
incorporated by reference.
TECHNICAL FIELD
[0002] The present invention relates generally to devices and
methods for sampling and handling of bodily fluids and performing
diagnostics in respect of the bodily fluids.
BACKGROUND TO THE DISCLOSURE
[0003] There are many medical conditions in humans and animals for
which it is desirable to draw a fluid sample for immediate analysis
at the point of sampling. For example, in diagnosis of various
diseases, a blood sample drawn from a patient is analyzed for the
presence of a blood-borne pathogen. Alternatively a blood sample
can be used to determine the presence or absence of healthy levels
of specific blood components. Blood samples are also screened for
molecular diagnostics to provide diagnosis, classification,
detection, monitoring, prognosis or other molecular inference.
[0004] Samples taken from a patient, animal or organism may be
obtained by penetrating the skin of the user using a piercing,
slicing, puncturing, pricking, or cutting element such as a lancet
device. A lancet device typically includes a body and a lancet. The
body is typically adapted to be held by the user, the lancet being
coupled to the body and being adapted to pierce the skin of the
patient so as to draw blood therefrom. In some lancet devices, the
lancet extends from the body at all times. In other lancet devices,
the lancet is adapted to be moved, when actuated, from a retracted
position in which the lancet tip is disposed within the body to an
extended position in which the lancet tip extends beyond the body.
Typically, the movement of the lancet from its retracted position
to its extended position is effected with a force that means
contact of the moving lancet tip with the skin of a patient results
in the penetration of the skin of the patient. In many such lancet
devices having a movable lancet, the lancet is automatically drawn
back into the body after reaching its extended position in order to
minimize the risk of inadvertent lancet sticks.
[0005] After the skin, typically of a finger or heel, is penetrated
by the lancet, the blood must be expressed from the user and
retained for delivery to a test element.
SUMMARY OF THE INVENTION
[0006] In some forms, disclosed is an assembly for sampling bodily
fluid, the assembly comprising a membrane penetration device
comprising a membrane penetrating element for penetrating a bodily
membrane to release a bodily fluid; and, a collector configured in
a collection position to take up the released bodily fluid and
retain the fluid for delivery to a test element. In some forms the
collector is configured to take up the released bodily fluid by
capillary action.
[0007] In some forms disclosed is a collector for taking up and
retaining a bodily fluid, the collector configured to be engaged
with a membrane penetration device including a membrane penetrating
element for penetrating a bodily membrane to release a bodily
fluid, the collector adapted in a collection position to take up
the released fluid and retain the fluid for delivery to a test
element. In some forms the collector is configured to take up the
released bodily fluid by capillary action. In some forms the
collector is configured to take up fluid through a pressure
differential. In some forms the collector is configured to take up
the released bodily fluid by suction. In some forms the collector
is configured to take up the released bodily fluid through
application of a force.
[0008] The foregoing summary is illustrative only and is not
intended to be in any way limiting. In addition to the illustrative
aspects, embodiments, and features described above, further
aspects, embodiments and features will become apparent by reference
to the drawings and the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] A preferred embodiment will now be described by way of
example only, with reference to the accompanying drawings in
which:
[0010] FIG. 1 is a perspective view of one embodiment of an
assembly;
[0011] FIG. 2 is a side view of the assembly of FIG. 1;
[0012] FIG. 3 is a cross-sectional view of the assembly of FIG.
1;
[0013] FIG. 4 is a detail cross-sectional view of the assembly of
FIG. 1;
[0014] FIG. 5 is a detail cross-sectional view of a second
embodiment of the assembly;
[0015] FIG. 6 is a side view of the assembly of FIG. 1;
[0016] FIG. 7 is a cross-sectional view of the assembly of FIG.
1;
[0017] FIG. 8 is a side view of the assembly of FIG. 1;
[0018] FIG. 9 is a cross-sectional view of the assembly of FIG.
1;
[0019] FIG. 10 is a cross-sectional view of a third embodiment of
an assembly;
[0020] FIG. 11 is a cross-sectional view of the assembly of FIG.
10;
[0021] FIG. 12 is a side view of a fourth embodiment of an
assembly;
[0022] FIG. 13 is a side view of the assembly of FIG. 12;
[0023] FIG. 14 is a side view of the assembly of FIG. 12;
[0024] FIG. 15 is a side view of the assembly of FIG. 12;
[0025] FIG. 16 is a cross section view of a collector of one
embodiment of the assembly;
[0026] FIG. 17 is a side view of the collector of FIG. 16;
[0027] FIG. 18 is a perspective view of the collector of FIG.
16;
[0028] FIG. 19 is an end view of the collector of FIG. 16;
[0029] FIG. 20 is a cross-sectional view of a fifth embodiment of
an assembly;
[0030] FIG. 21 is a cross-sectional view of the assembly of FIG.
20;
[0031] FIG. 22 is a cut away perspective view of the assembly of
FIG. 20;
[0032] FIG. 23 is a cut away perspective view of the assembly of
FIG. 20;
[0033] FIG. 24 is a cut away perspective view of the assembly of
FIG. 20;
[0034] FIG. 25 is a cross-sectional view of the assembly of FIG.
20;
[0035] FIG. 26 is a cross-sectional view of the assembly of FIG.
20;
[0036] FIG. 27 is a perspective view of a second embodiment of the
collector;
[0037] FIG. 28 is a perspective view of a sixth embodiment of an
assembly;
[0038] FIG. 29 is a perspective view of the assembly of FIG.
28;
[0039] FIG. 30 is a perspective view of the assembly of FIG.
28;
[0040] FIG. 31 is a side view of a seventh embodiment of an
assembly;
[0041] FIG. 32 is a cross-sectional view of the assembly of FIG.
31;
[0042] FIG. 33 is a cross-sectional view of the assembly of FIG.
31;
[0043] FIG. 34 is a perspective view of an eighth embodiment of the
assembly;
[0044] FIG. 35 is a perspective view of the assembly of FIG.
34;
[0045] FIG. 36 is a perspective view of the assembly of FIG.
34;
[0046] FIG. 37 is a cut away perspective view of a ninth embodiment
of an assembly;
[0047] FIG. 38 is a cut away perspective view of the assembly of
FIG. 37
[0048] FIG. 39 is a lateral cross-sectional view of a tenth
embodiment of the assembly;
[0049] FIG. 40 is a cut away perspective view of the assembly of
FIG. 39;
[0050] FIG. 41 is a top view of an eleventh embodiment of an
assembly;
[0051] FIG. 42 is a bottom view of the assembly of FIG. 41;
[0052] FIG. 43 is a bottom view of the assembly of FIG. 41 with
fluid collection element extended;
[0053] FIG. 44 is a top isometric view of the assembly of FIG.
41;
[0054] FIG. 45 is a bottom isometric view of the assembly of FIG.
41.
DETAILED DESCRIPTION OF EMBODIMENT
[0055] In the following detailed description, reference is made to
accompanying drawings which form a part of the detailed
description. The illustrative embodiments described in the detailed
description, depicted in the drawings and defined in the claims,
are not intended to be limiting. Other embodiments may be utilised
and other changes may be made without departing from the spirit or
scope of the subject matter presented. It will be readily
understood that the aspects of the present disclosure, as generally
described herein and illustrated in the drawings can be arranged,
substituted, combined, separated and designed in a wide variety of
different configurations, all of which are contemplated in this
disclosure.
[0056] This disclosure is directed generally to an assembly for
sampling bodily fluids. While the assembly has been frequently
described with reference to a lancet, it will be clear to a person
skilled in the art that alternatives are available.
[0057] In some forms disclosed is an assembly for sampling bodily
fluid, the assembly comprising a membrane penetration device
comprising a membrane penetrating element for penetrating a bodily
membrane to release a bodily fluid; and, a collector configured in
a collection position to take up the released bodily fluid and
retain the fluid for delivery to a test element.
[0058] In some forms the collector is configured to take up the
released bodily fluid by capillary action. In some forms the
collector is configured to take up fluid through a pressure
differential. In some forms the collector is configured to take up
the released bodily fluid by suction. In some forms the collector
is configured to take up the released bodily fluid through
application of a force.
[0059] In some forms the collector comprises a body defining a
cavity configured to generate capillary action.
[0060] In some forms the collector includes a capillary channel. In
some forms the capillary channel is a closed channel. In some forms
the capillary channel is an open channel.
[0061] In some forms the collector comprises a tube.
[0062] In some forms the tube extends between an collection opening
and a release opening and is tapered toward the collection
opening.
[0063] In some forms the assembly includes a housing which houses
the membrane penetration device and the tube is angled with respect
to the housing.
[0064] In some forms the collector comprises two substantially
parallel plates.
[0065] In some forms the collector is moveably engaged with the
body
[0066] In some forms the collector is pivotably engaged with the
body
[0067] In some forms the assembly includes a test element and the
collector is moveable between the collection position and a
delivery position in which the retained fluid is releasable so as
to contact the test element.
[0068] In some forms in the delivery position the fluid is in
contact with the test element and the collector.
[0069] In some forms the collector comprises at least one opening
which, in the delivery position, is in contact with the test
element.
[0070] In some forms the opening is proximal to the test
element.
[0071] In some forms the assembly comprises a housing and the
membrane penetrating element is actuatable to adopt an actuated
position in which the membrane penetrating element extends beyond
the housing.
[0072] In some forms the membrane penetrating element is configured
to adopt a retracted position in which the membrane penetrating
element is located within the housing after actuation.
[0073] In some forms the collector is inhibited from moving into
the delivery position until the membrane penetrating element is
actuated.
[0074] In some forms the collector includes a ventilation
aperture.
[0075] In some forms the collector comprises a tube extending
between two openings and a ventilation aperture is positioned
intermediate the openings.
[0076] In some forms the ventilation aperture comprises a slot
extending between the openings.
[0077] In some forms the collector is configured to take up a
predetermined volume of fluid.
[0078] In some forms the predetermined volume of fluid is regulated
by a dimensional characteristic of the collector.
[0079] In some forms the collector includes an interior cavity and
the predetermined volume of fluid is regulated by the size and
shape of the cavity.
[0080] In some forms the collector includes at least one opening
for uptake of the fluid and wherein the opening is adapted to
facilitate fluid uptake.
[0081] In some forms the internal surface of the collector is raked
toward the opening.
[0082] In some forms the collector includes an internal cavity and
the internal diameter of the cavity increases toward the
opening.
[0083] In some forms the collector comprises at least one
collection opening for uptake of the released fluid, the assembly
further comprising a cover configured to cover the opening.
[0084] In some forms the collector is moveable between the
collection position and a delivery position and the cover blocks
the collection opening in the delivery position.
[0085] In some forms the rate of movement of the collector between
the collection position and the delivery position is
controlled.
[0086] In a second aspect, disclosed is a collector for taking up
and retaining a bodily fluid, the collector configured to be
engaged with a membrane penetration device including a membrane
penetrating element for penetrating a bodily membrane to release a
bodily fluid, the collector adapted in a collection position to
take up the released fluid and retain the fluid for delivery to a
test element.
[0087] In some forms the collector is configured to take up the
released bodily fluid by capillary action.
[0088] In some forms the collector comprises a body defining a
cavity configured to generate capillary action.
[0089] In some forms the collector includes a capillary
channel.
[0090] In some forms the collector is configured to take up a
predetermined volume of fluid.
[0091] In some forms the predetermined volume of fluid is regulated
by a dimensional characteristic of the collector.
[0092] In some forms the collector includes an interior cavity and
the predetermined volume of fluid is regulated by the size and
shape of the cavity.
[0093] In a third aspect, disclosed is an assembly for sampling
bodily fluid, the assembly comprising a membrane penetration device
comprising a membrane penetrating element for penetrating a bodily
membrane to release a bodily fluid; and, a collector configured to
take up and retain the released bodily fluid until moved into a
delivery position in which the fluid is releasable for delivery to
a test element.
[0094] In a fourth aspect disclosed is an assembly comprising a
membrane penetration device comprising a membrane penetrating
element for penetrating a bodily membrane to release a bodily
fluid; and, a collector configured in a collection position to take
up the released bodily fluid and deliver the fluid to a test
element.
[0095] In some forms the collector is configured to take up the
fluid by capillary action.
[0096] In some forms the collector comprises a tube.
[0097] In some forms the collector extends between an collection
opening and a discharge opening and wherein a ventilation aperture
is positioned intermediate the collection opening and the discharge
opening.
[0098] In some forms the ventilation aperture comprises a slot
extending between the collection opening and the discharge
opening.
[0099] In a fifth aspect, disclosed is an assembly for sampling a
bodily fluid, the assembly comprising a membrane penetration device
comprising a membrane penetrating element for penetrating a
membrane to release a bodily fluid; and, a retainer adapted to
retain a collector adapted for taking up the released bodily
fluid.
[0100] In some forms the retainer comprises a cavity extending into
the body.
[0101] In some forms the retainer comprises a clip engaged with the
body.
[0102] In some forms the retainer comprises a pivotable
engagement.
[0103] In some forms the retainer is adapted to allow a collector
to be retained in a position that is accessible for use.
[0104] In some forms the retainer is adapted to allow a collector
to be retained with respect to the assembly such that the collector
is moveable between a retained position and an operative
position.
[0105] In some forms the retainer is adapted to allow the removal
of the collector from the retainer.
[0106] In some forms the collector is a capillary tube.
[0107] In some forms the collector is a pipette.
[0108] In some forms the collector is a reservoir.
[0109] In some forms the collector comprises a loop for collecting
fluid.
[0110] In some forms the assembly further comprises a collector
configured to take up bodily fluid and retain it for delivery to a
test element, the collector being engaged with the retainer.
[0111] In some forms the collector is a capillary tube.
[0112] In some forms the collector is removably engaged with the
retainer.
[0113] In some forms the collector is moveable between a retained
position and an operative position. In some forms the collector is
pivotable between a retained position and an operative
position.
[0114] In some forms the collector is adapted to contain a
substance.
[0115] In some forms the substance may be a buffer, a reagent or a
physiologically acceptable solution. In some forms the substance
may be a fluid. In some forms the substance may be effective to
react with the bodily fluid.
[0116] In some forms the collector comprises a reservoir for
containing a substance.
[0117] In a sixth aspect, disclosed is an assembly for sampling
bodily fluid, the assembly comprising a membrane penetration device
comprising a membrane penetrating element for penetrating a bodily
membrane to release a bodily fluid; and, a collector configured to
adopt a collection position to take up the released bodily fluid
and a delivery position to deliver the fluid to a test element.
[0118] In some forms the collector is configured to move between
the collection position and the delivery position.
[0119] In some forms the movement of the collector between the
collection position and the delivery position comprises
pivoting.
[0120] In some forms the movement of the collector between the
collection position and the delivery position comprises
sliding.
[0121] In some forms the movement of the collector between the
collection position and the delivery position comprises
translation.
[0122] In some forms the movement of the collector between the
collection position and the delivery position comprises a
combination of two or more of pivoting, rotating, sliding or
translating.
[0123] In some forms in the delivery position the collector is in
contact with the test element.
[0124] In some forms the assembly is configured such that movement
of the collector between the collection position and the delivery
position is controlled.
[0125] In some forms the assembly is configured such that movement
of the collector between the collection configuration and the
delivery configuration is achieved manually.
[0126] In some forms the movement is controlled by means of
resistance fit.
[0127] In some forms the test element is located within the
assembly such that in the delivery position the test element gives
under pressure placed on the test element by the collector.
[0128] In some forms the membrane is skin and the bodily fluid is
blood.
[0129] In at least some forms the assembly allows a user to sample
a bodily fluid from a penetration site and have the fluid taken up
into a collector for delivery to a test element. The test element
may be integrated into the assembly or may be a separate device or
system. In some forms the volume of fluid taken up can be
quantified or regulated through a dimensional characteristic of the
collector such as the internal geometry of a channel or cavity
extending therethrough. In some forms the assembly limits the
formation of bubbles in the collector through use of a ventilation
aperture. In some forms the assembly restricts a user from adding
additional fluid to the test element during or after discharge. In
some forms the assembly allows simple and even one-handed sampling
of a bodily fluid.
[0130] Referring to the figures, in some forms illustrated in FIGS.
1 through 9, disclosed is an assembly 1 for sampling a bodily
fluid. The assembly 1 generally comprises a housing 3 which extends
from a penetration end 4 and houses a membrane penetration device 5
incorporating a membrane penetrating element 6. In the illustrated
form the membrane penetrating element 6 is in the form of a lancet
7 adapted to be positioned within the housing 3 prior to actuation
of the membrane penetration device 5. The membrane penetration
device is actuated by contact with actuator 8 which releases the
lancet such that the lancet extends beyond the housing 3 and can be
utilized to penetrate a bodily membrane such as skin to release a
bodily fluid such as blood. After actuation in the illustrated form
the lancet retracts back into the housing to protect a user from
further sticks.
[0131] The housing 3 further houses a test element 9. In the
illustrated form the test element 9 comprises a test strip
incorporated into the housing 3 and accessible through delivery
window 10 however it will be clear to a person skilled in the art
that alternative test elements are available to provide a
diagnostic, including but not limited to lateral flow test strips,
vertical flow test strips, agglutination, solid-phase technologies,
microfludics and lab on a chip technologies. The housing further
comprises a test results window 12 which allows a user to view the
results of a test.
[0132] A collector 14 is engaged with the housing 3. In the
illustrated form the collector 14 is engaged by means of at least
one engagement arm 15 which engages the housing 3 at engagement
point 16. The engagement arms 15 are rotatable about an axis
centered on engagement point 16.
[0133] Rotation of engagement arms 15 moves the collector 14 with
respect to the body 3.
[0134] In the illustrated form shown in FIGS. 1 through 9, the
collector 14 comprises a capillary tube 17 extending between a
collection opening 18 and a discharge opening 19. A channel 21
extends through the capillary tube 17 and is adapted to generate
capillary action and take up fluid into the collector 14.
[0135] The collector 14 is moveable by rotation of engagement arms
15 from a collection position as shown in FIGS. 1 through 7 to a
delivery position as shown in FIGS. 8 and 9. In the collection
position the collector extends at an angle with respect to the
housing 3 to allow for easy access to the collection opening 18. In
this position the discharge opening 19 of the collector 14 is
spaced apart from the test element 9 situated behind delivery
window 10.
[0136] As shown best in FIG. 4 the capillary tube 16 is tapered
toward the collection opening 18. As a result of the tapering the
tip of the capillary tube presents a small cross-sectional area.
This limits the fluid that is in contact with the capillary tube
body rather than the internal cavity and promotes movement of fluid
into the collector 14 rather than on the surface. In some forms the
internal surface of the capillary tube is raked toward the
collection opening 18 as shown in FIG. 5. These features facilitate
the uptake of fluid into the collector.
[0137] In the illustrated form the collector is sized and shaped to
allow a predetermined volume of fluid to be taken up into the
capillary tube. The internal geometry including diameter and length
of the channel 21 regulates the volume of fluid taken up into the
collector 14. Alternatively an indicator can be located on the
collector to allow a user to determine the volume of fluid held
within the collector 14.
[0138] When the collector 14 is moved into the delivery position
the discharge opening 19 of the collector 14 contacts the test
element 9 to allow release of the fluid retained within the channel
21 in the capillary tube 16. Fluid is released through wicking away
from the point of contact between the collector 14 and the test
element 9.
[0139] Thus in use a user positions a bodily membrane at the
penetration end 4 of the housing and actuates the membrane
penetration device 5 such that the lancet 7 pierces the bodily
membrane and is retracted again into the housing 3. The user then
positions the finger at the collection opening 18 of the collector
and bodily fluid is taken up into the collector 14 by capillary
action.
[0140] The user then moves the collector 14 into the delivery
position as shown in FIGS. 8 and 9. In the delivery position the
discharge opening 19 contacts the test element 9 and fluid retained
within the collector by capillary action is released onto the test
element.
[0141] In other forms illustrated in FIGS. 10 and 11, the collector
14, still in the form of a capillary tube 16, is moveable between
the collection position shown in FIG. 10 and the delivery position
shown in FIG. 11 through sliding the collector 14 longitudinally
into contact with the test element 9. In this form the user allows
fluid uptake into the collector then slides the collector 14 into
contact with the test element to allow release of the retained
fluid onto the test element.
[0142] In other forms illustrated in FIGS. 12 through 19, the
collector 14 is in the form of a capillary plate 30 which comprises
two substantially parallel plates 31 defining a channel or cavity
32 therebetween.
[0143] The collector 14 in the form of the capillary plate 30 is
shown best in FIGS. 17 through 19 which disclose parallel plates 31
defining a cavity 32 therebetween which is sized and shaped to
generate capillary action. A user positions a pierced membrane on
collection opening 38 and allows bodily fluid to be taken up into
the cavity 32. A ventilation aperture 34 is positioned facing the
opening 38 to limit the formation of air bubbles in the cavity as
well as reducing problems in the subsequent delivery or release of
the fluid due to air entrapment. The user then rotates the
capillary plate 30 into the delivery position as shown in FIGS. 14
and 15. In the delivery position the discharge opening 39 contacts
the test element (not illustrated in these Figs) allowing release
of the fluid onto the test element.
[0144] In other forms illustrated in FIGS. 20 through 27, the
collector is again in the form of a capillary tube 16. In this form
the capillary tube includes a ventilation aperture 40. In the
illustrated form the ventilation aperture 40 is in the form of a
longitudinally extending slit 41 which extends between the
collection opening 18 and the discharge opening 19. The ventilation
aperture 40 allows for release of air while the bodily fluid is
taken up into the capillary tube 16. This limits the formation of
bubbles within the collector 14 which allows for more accurate
volume of fluid to be retained in the collector 14.
[0145] The collector 14 and engagement arms 15 are independently
shown in FIG. 27 which shows the collector 14 engaged with the
engagement arms 15. The engagement arms 15 extend from the
collector 14 to engagement points 16 at which the engagement arms
are pivotally connected with the housing 3 of the assembly 1 by
means, in the illustrated form, of flange 17 and hinge pin 45 which
engage the housing 3 such that the flange 17 abuts an internal
shoulder or wall in the housing 3. The engagement arms 15 define a
curved U or C shape which meets at the collector 14.
[0146] FIGS. 19 through 24 show forms in which the collector 14 is
moveable between the collection position and the delivery position
only after actuation of the membrane penetration device. In the
illustrated forms rotation of the collector 14 into the discharge
position is prevented by locking mechanism 50 which comprises a
locking plate 51 which blocks movement of flange 17 about its axis.
The flange 17 includes a flat surface 52 which abuts against
locking plate 51 when the locking plate 51 is in a locking
position. Actuation of the membrane penetration device 5 to release
membrane penetration element 6 effects movement of the locking
plate 51 away from the penetration end 4 of the housing 3 and into
an unlocked position. This moves the locking plate 51 out of
abutment with the flange 17 and allows rotation of the flange 17
about its axis which effects rotation of the collector 14 into the
delivery position.
[0147] FIGS. 25 and 26 show forms of the assembly in which the
movement of the collector into the delivery position is controlled
by means of a cantilever effect in order to minimize spillage and
protect the test element 9. In the illustrated form the housing
includes a slot on either side of the test element 9 to allow for
flexion in the engagement arms 15 to take up the force of movement
of the collector 14. The assembly 1 further includes a flexion
element 65 positioned beneath the test element 9 to allow for
flexion of the test element 9 and limit compression of the test
element. This allows the collector 14 to stop softly at the test
element 9. Compression of the test element can result in the fluid
not wicking away from the contact point between the collector 14
and the test element 9 which reduces the accuracy and effectiveness
of the assembly. Further, an abrupt stop of the collector 14
against the test element 9 can result in spillage or flicking of
the fluid. This feature in some forms has the advantage of soaking
up tolerances in the assembly.
[0148] FIGS. 28 through 30 show an assembly 1 where the collector
14 in the form of a capillary tube 16 is prevented from rotating
into the discharge position. In the illustrated form this
prevention is by means of a manual locking plate 60 which is
manually slideable between a locking position in which it prevents
the collector 14 and engagement arms 15 from rotating as shown in
FIG. 28 to a position more distal from the penetration end 4 of the
housing 3 which allows rotation of the collector 14 and engagement
arms 15 as shown in FIGS. 29 and 30.
[0149] FIGS. 31 through 33 show an assembly 1 in which the
collection opening 18 of the capillary tube 16 is moveable into a
closed position when delivery of the fluid occurs. In the delivery
position as shown in FIG. 33, the collector 14 is located beneath a
raised cover 70 which is spaced apart from the delivery window 10
such that when the collector 14 is moved into the delivery position
the cover 70 blocks access to the collection opening 18. This
effectively blocks a user from maintaining the membrane on the
collector and allowing excess fluid to be taken up by the
collector.
[0150] In some forms as illustrated in FIGS. 34-36, a delivery
cover 90 is shown. The delivery cover 90 is moveable between a
closed position as shown in FIG. 34 in which the cover 90 blocks
access to the delivery window 10 and an open position as shown in
FIG. 36. In the illustrated form rotation of the engagement arms 15
effects movement of the delivery cover 90 to allow the collector 14
to contact the test element 9 through the delivery window 10. In
not illustrated forms movement is actuated by the user by, for
example, sliding, unclipping, moving or rotating the cover.
[0151] In some forms the movement of the collector into the
delivery position is coupled with the movement of a delivery cover
in order to encourage the correct sequence of steps for a user. In
some forms the movement of the collector into the delivery position
is coupled with the movement of a collector cover, similarly in
order to encourage the correct step sequence.
[0152] In some forms as shown in FIGS. 37 through 40, movement of
the collector 14 by means of the engagement arms 15 between the
collection position and the delivery position is slowed or smoothed
through generating a resistance fit between the outer surface 81 of
flange 17 and the housing 3 at abutment surface 80. Thus friction
between the flange 17 and abutment surface 80 of the housing 3 is
utilized to control rotation of the engagement arms limiting the
likelihood of spillage of the fluid and reducing the force of the
collector 14 on the test element 9.
[0153] In at least one form the sampling assembly allows a user to
collect a bodily fluid from the site of membrane penetration
without additional steps such as finding a collection device or
container and expressing the fluid onto the device. The fluid
collection element allows for easy and safe fluid collection from
the piercing site. In some forms the simplicity is increased by
allowing a user to prepare the site and removing the necessity of
finding an alcohol wipe and a drying or cleansing wipe for
treatment afterwards. This significantly simplifies the process of
collecting blood either for a health care professional or for a
home user. In at least another form, the assembly allows a user to
collect a bodily fluid with a fluid collection element such as a
capillary tube, pipette, reservoir or looped wand and deposit it at
a collection point where it and a physiologically acceptable
solution are brought into contact with a test material. In one form
the fluid collection element is integrated and positioned for
convenient sample collection near the blood collection site. In
another form the fluid collection element is moveable between a
retained position and an operative position. In one form the fluid
collection element is moveable between an operative position for
collection of a bodily fluid and a delivery position for delivery
of the fluid sample to a diagnostic device.
[0154] In use in one form a user obtains a sterile wipe from the
composite system, cleans a penetration site, activates the piercing
element to penetrate the user's skin, before or after moving the
fluid collection element into an operative position. The user will
ordinarily wipe away a first drop of blood using a wipe then
position the fluid collection element to collect the bodily fluid
released from the penetration site. The user then, if necessary,
positions the fluid collection element to release the bodily fluid
onto a collection window. The user then actuates a buffer or
diluent delivery to carry the fluid across a test or diagnostic
strip. The sampling assembly then displays a result of the
diagnostic test.
[0155] In not illustrated forms, delivery onto the test element is
by means of dropping, squeezing, spraying or other alternative
delivery methods that may or may not include contact with the test
element. For example, in some forms the collector comprises a
pipette including a bulb which is squeezed to deliver the fluid to
the test element.
[0156] In some not illustrated forms the collector is adapted to
contain a substance such as a diluent, a buffer, a reagent, a
physiologically acceptable solution, a reactant or other solutions,
powders, fluids or substances appropriate for an aspect of the
process of testing a bodily fluid. In some not illustrated forms
the collector comprises a reservoir for containing a substance.
[0157] In some not illustrated forms, the reservoir can receive
substances either prior or post uptake of the sample.
[0158] In some not illustrated forms, the collector includes one
opening which acts as collection opening and discharge opening. In
some forms the collector also include a ventilation aperture.
[0159] In an embodiment as shown in FIG. 41 through 45, disclosed
is an assembly 101 for collecting and handling a sample of a bodily
fluid. The assembly 101 is described with reference to collecting
and handling blood samples, though a person skilled in the art will
be aware that other bodily fluids may be collected using the
assembly.
[0160] The assembly 101 comprises a body 102 comprising a membrane
piercing element (not illustrated) which extends from a membrane
piercing point 104 to allow a user to pierce skin or another
membrane. The membrane piercing element comprises a lancet such as
a needle or blade or other sharp which disposed prior to use within
the body 102. The lancet is moveable from a housed position in
which the lancet is substantially disposed within the body 102. In
this position the lancet is protected by the body 102. This
position is shown in the Figures. The lancet is moveable to an
extended position (not illustrated) in which the lancet extends at
least partly from the body 102. In this position the tip of the
lancet is positioned outside the body 102 such that a user can
prick, pierce, cut or otherwise penetrate the skin with the
lancet.
[0161] The movement of the lancet from the housed position to the
extended position is performed with sufficient force to pierce the
skin of a user such that if the body 102 is positioned against the
skin of the user and movement of the lancet between the housed and
the extended position is actuated the skin will be pierced by the
lancet.
[0162] The sampling assembly 101 further comprises a collector
retainer 107 which is disposed within the body 102. The collector
retainer 107 is composed of a cavity extending into the body 102
however a person skilled in the art will be aware that other
configurations will allow for retention of a fluid collection
element such as a capillary tube, pipette, reservoir or looped
wand. For example, a clip, sheath or hinge can be utilised as the
fluid collection element retainer. Alternatively a hinge could be
utilised.
[0163] A fluid collection element in the form of a capillary tube
108 is removably positioned within the fluid collection element
retainer 107. The capillary tube 108 is configured to allow
capillary action and is composed of any material allowing
sufficient wetting of the capillary interior for capillary action
of a bodily fluid to take place. However a person skilled in the
art will be aware that alternative embodiments not utilizing
capillary action will be available.
[0164] In use, a user removes the capillary tube 108 from the
retainer 107 before or after locating the piercing membrane point
against the skin at the site where the blood is to be sampled. The
user actuates the device such that the lancet moves from the housed
position to the extended position, piercing the skin and allowing
blood to be expressed. The lancet then returns automatically to the
housed position.
[0165] Activation of the device between the housed position and the
extended position occurs through depression of the membrane
piercing point 104 into the body by the user's finger although a
person skilled in the field will be aware that a separate actuation
button or lever may be utilised.
[0166] The user then utilizes the capillary tube 108 and positions
it such that blood which is expressed from the piercing is taken up
by the tube 108 merely by contacting the blood with the tube 8. A
particular amount of blood can be stored by the tube 108 depending
upon the length of the tube, making the device suitable with
quantitative diagnostic applications.
[0167] The user then positions the capillary tube over the bodily
fluid collection point 112 and bodily fluid, in this case blood, is
delivered to the collection point.
[0168] In not illustrated forms the fluid collection element is a
pipette, a reservoir or a wand having a loop for collection of
fluid. A person skilled in the art will be aware that other fluid
collection elements designed to collect blood from a user and
transfer it to the fluid collection point.
[0169] The assembly 101 further comprises a buffer reservoir for
holding a physiologically acceptable solution such as a buffer or
diluent for supporting the blood or other bodily fluid and aiding
in conveying the bodily fluid. A solution delivery actuator 113 is
positioned on the assembly 101. Actuation of the solution delivery
actuator 113 releases the buffer solution from an internal
reservoir and delivers it to a diagnostic device or assay including
but not limited to lateral flow test strips, vertical flow test
strips or agglutination and solid-phase technologies.
[0170] The diagnostic device further includes a results window 114
which is positioned for easy viewing of the results of any
diagnostic test performed.
[0171] The buffer or diluent reservoir and test strip are
positioned internally to the device and therefore not illustrated
in the Figures.
[0172] A sterile wipe locator 117 and an adhesive plaster locater
118 are positioned on one side of the body 102 to allow for ease of
access for a user.
[0173] In not illustrated embodiments, the fluid collection element
is retained by the sampling assembly in a position where the user
can contact the penetration site to the fluid collection element
after piercing without removing the fluid collection element from
the fluid collection element retainer. For example, the fluid
collection element may be oriented to allow access to the fluid
collection element without movement of the fluid collection
element. The fluid collection element may be oriented to deliver
the fluid to the collection point without movement of the fluid
collection element.
[0174] Alternatively the fluid collection element may be moveable
between an inoperative and an operative position without removing
the fluid collection element from the fluid collection element
retainer. In one example the fluid collection element may be
hingedly retained or in an alternative the fluid collection element
may be retained by a cord or biasing means such as a spring.
[0175] In a further not illustrated embodiment, the fluid
collection element may be associated with a lancet or other
penetration device for fluid collection. The fluid collection
element can then be utilised to collect and transport the fluid for
testing and diagnosis at a separate location.
[0176] Throughout the detailed description, the membrane
penetrating element has been referred to and described in respect
of a lancet as illustrated, however persons skilled in the art will
be aware that the lancet could be any piercing, slicing, cutting,
puncturing or pricking element which allows a user to penetrate a
membrane such as the skin to allow a fluid sample to be
released.
[0177] Throughout the detailed description reference to capillary
action is used to refer to the taking up of a fluid through
adhesion of a fluid with a surface of the collector and/or surface
tension of that fluid.
[0178] In the claims which follow and in the preceding description
of the invention, except where the context requires otherwise due
to express language or necessary implication, the word "comprise"
or variations such as "comprises" or "comprising" is used in an
inclusive sense, i.e. to specify the presence of the stated
features but not to preclude the presence or addition of further
features in various embodiments of the invention.
[0179] Variations and modifications may be made to the parts
previously described without departing from the spirit or ambit of
the invention.
* * * * *