U.S. patent application number 12/822650 was filed with the patent office on 2010-10-14 for devices and methods for reduced-pain blood sampling.
This patent application is currently assigned to RAPIDX LTD.. Invention is credited to Nili TAMIR.
Application Number | 20100261988 12/822650 |
Document ID | / |
Family ID | 40801641 |
Filed Date | 2010-10-14 |
United States Patent
Application |
20100261988 |
Kind Code |
A1 |
TAMIR; Nili |
October 14, 2010 |
DEVICES AND METHODS FOR REDUCED-PAIN BLOOD SAMPLING
Abstract
Systems, methods and devices are provided for invasive
reduced-pain blood sampling and testing, the devices including, a
horizontally-disposed finger support element configured to support
the finger thereupon, a finger holding element adapted, in a closed
position, to radially grip the finger on said support element near
to a tip thereof and configured to force blood into said tip, a
lancet housing element disposed vertically underneath the finger
support element for piercing the finger tip with a lancet while
said finger tip is gripped by said finger holding element and
supported by said finger support element; and a test strip
conveying element adapted to be received by the finger support
element after retraction of the lancet housing element thereby
bringing a test strip into direct contact with a predetermined
volume of blood from said finger support element thereby effecting
a blood test.
Inventors: |
TAMIR; Nili; (Zihron Yaakov,
IL) |
Correspondence
Address: |
OLIFF & BERRIDGE, PLC
P.O. BOX 320850
ALEXANDRIA
VA
22320-4850
US
|
Assignee: |
RAPIDX LTD.
Tel Aviv
IL
|
Family ID: |
40801641 |
Appl. No.: |
12/822650 |
Filed: |
June 24, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/IL2008/001669 |
Dec 25, 2008 |
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12822650 |
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61016580 |
Dec 25, 2007 |
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61018901 |
Jan 4, 2008 |
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Current U.S.
Class: |
600/365 ;
600/583; 600/584; 606/181 |
Current CPC
Class: |
A61B 5/150114 20130101;
A61B 5/150519 20130101; A61B 5/15144 20130101; A61B 5/15105
20130101; A61B 5/15087 20130101; A61B 5/150343 20130101; A61B
5/150358 20130101; A61B 5/150412 20130101; A61B 5/150824 20130101;
A61B 5/14532 20130101; A61B 5/150748 20130101; A61B 5/15117
20130101; A61B 5/15113 20130101; A61B 5/6826 20130101; A61B
5/150022 20130101; A61B 5/14546 20130101; A61B 5/14552 20130101;
A61B 5/157 20130101; A61B 5/15142 20130101; A61B 5/6838
20130101 |
Class at
Publication: |
600/365 ;
606/181; 600/583; 600/584 |
International
Class: |
A61B 5/145 20060101
A61B005/145; A61B 5/151 20060101 A61B005/151; A61B 5/157 20060101
A61B005/157 |
Claims
1. A medical device for a blood test, the device comprising: (i) a
housing defining a finger site for supporting a user's finger or a
portion thereof within said finger site during the device
operation; (ii) piercing, sampling and testing assemblies
sequentially actuatable to successively initiate piercing, sampling
and testing operational modes of the device; (iii) a carriage at
least partially accommodated within said housing and being adapted
for movement with respect to said finger site between its first
position corresponding to the piercing mode of the device and a
second position corresponding to the sampling and testing modes of
the device, the device being thereby capable of operating in the
piercing, sampling and testing modes while at a static position of
the user's finger.
2. A device according to claim 1, wherein the piercing assembly is
accommodated inside said housing with respect to the finger site
such that an operation of the piercing assembly in the piercing
mode of the device is hidden from the user.
3. A device according to claim 1, comprising a finger holder
element configured to be fit on the finger such as to apply
pressure to the finger in a manner assisting in withdrawal of blood
during the piercing and sampling modes and reducing pain associated
with the blood test.
4. A device according to claim 3, wherein said finger holder
comprises a band operable to be shifted from its open inoperative
position to a closed-loop operative position in which it fits the
finger, said band when in the operative position thereof applies
the pressure to the finger while preventing over-pressing of the
finger, thereby reducing pain involved in the blood test
procedures.
5. A device according to claim 1, comprising a finger holder
element configured to be fit on the finger such as to apply
pressure to a certain location on the finger, said certain location
being selected to be spaced a predetermined distance from at least
one of the finger tip and a piercing orifice provided in said
finger site.
6. A device according to claim 5, wherein said housing comprises a
groove located within said finger site and being configured for
immobilizingly receiving a portion of the finger holder element
therein, thereby fixing a position of the finger with respect to
said finger site, during the device operation, said groove being
located at a predetermined distance from the piercing orifice,
thereby ensuring the application of pressure to the finger by said
finger holder element a certain predetermined distance from a
location on the finger being pierced.
7. A device according to claim 1, wherein said housing comprises a
protrusion defining a distal end of the finger site to be abutted
by a finger tip during the device operation.
8. A device according to claim 7, comprising a finger holder
element configured to be fit on the finger such as to apply
pressure to a certain location on the finger, said certain location
being selected to be spaced a predetermined distance from the
protrusion, which is located a predetermined distance from a
piercing orifice provided in said finger site.
9. A device according to claim 1, wherein the piercing assembly
comprises a piercing element movable along a first axis towards and
away from the finger site and accessing the finger via an orifice
in said finger site to perform piercing.
10. A device according to claim 9, wherein said piercing assembly
being movable by said carriage along a second, intersecting axis,
with respect to the finger site, between its first inoperative
position in which the piercing element is not aligned with the
orifice along the first axis and a second operative position in
which the piercing elements is aligned with said orifice along the
first axis.
11. A device according to claim 1, wherein the sampling assembly
comprises a blood holding element for collecting a predetermined
volume of a liquid-phase blood sample flowing from the finger as a
result of piercing.
12. A device according to claim 11, wherein the blood holding
element is configured such that, when in the sampling mode of the
device, the blood holding element has a top portion formed with a
projecting sloped member for flowing a portion of collected blood
volume above said predetermined volume out of a liquid reservoir
towards an indication window, appearance of blood in the indication
window being indicative of that the blood holding element contains
the predetermined volume of blood.
13. A device according to claim 11, wherein the blood holding
element comprises a hollow liquid reservoir of the predetermined
volume for collecting the blood sample freely flowing from the
orifice, said liquid reservoir comprising a bottom plate movable
between its first position, in which it is aligned with side walls
of the reservoir, corresponding to a closed state of the reservoir
keeping collected blood in the reservoir, and a second position, in
which it is misaligned with the side walls corresponding to an open
state of the reservoir allowing blood flow from the reservoir onto
a test strip of the testing assembly.
14. A device according to claim 12, wherein the blood holding
element is a two-part element, the first part being in the form of
a hollow liquid reservoir of the predetermined volume for
collecting the blood sample freely flowing from the orifice, and
the second part being selectively movable to be brought into an
assembled position with said reservoir thereabove, thereby forming
the top portion of said blood holding element having said
projecting sloped member and displaced into a dissembled position,
said displacement removing excess blood from the reservoir.
15. A device according to claim 13, wherein the test strip is
insertable into a slot made in said housing in a manner enabling
sliding movement of the test strip towards and away from a location
of alignment with the piercing orifice.
16. A device according to claim 1, wherein the testing assembly
comprises a test strip selectively insertable into a position in
which a portion thereof is aligned with a piercing orifice to
receive a blood sample from the finger after piercing.
17. A device according to claim 16, wherein the test strip being
insertable into a slot made in said housing in a manner enabling
sliding movement of the test strip towards and away from a location
of alignment with the piercing orifice.
18. A device according to claim 17, wherein the sampling assembly
comprises a blood holding element for collecting a predetermined
volume of a liquid-phase blood sample flowing from the finger as a
result of piercing, the blood holding element comprising a hollow
liquid reservoir of the predetermined volume for collecting the
blood sample freely flowing from the orifice, said liquid reservoir
comprising a bottom plate movable between its first position, in
which it is aligned with side walls of the reservoir, corresponding
to a closed state of the reservoir keeping collected blood in the
reservoir, and a second position, in which it is misaligned with
the side walls corresponding to an open state of the reservoir
allowing blood flow from the reservoir onto said test strip.
19. A device according to claim 1, wherein said carriage
incorporates or is connected to elements of the piercing, sampling
and testing assemblies such that the movement of the carriage with
respect to the finger site successively brings said elements into
an operative position in which the element of the respective
assembly is aligned with the finger site corresponding to said
first and second positions of the carriage.
20. A device according to claim 1, comprising a reagent holding
unit mounted to be selectively brought into alignment position with
respect to an element of the testing assembly, when in the testing
mode of the device.
21. A medical device for a blood test, the device comprising: a
housing defining a finger site for supporting a user's finger or a
portion thereof within said finger site during the device
operation, and piercing, sampling and testing assemblies at least
partially accommodated in said housing, wherein the piercing
assembly comprises a piercing element movable towards and away from
the finger site accessing the finger via an orifice in said finger
site to perform piercing; the sampling assembly comprises a blood
holding element, which comprises a hollow liquid reservoir for
collecting blood freely flowing from the orifice, said liquid
reservoir comprising a bottom plate movable between its first
position, in which it is aligned with side walls of the reservoir,
corresponding to a closed state of the reservoir keeping collected
blood in the reservoir, and a second position, in which it is
misaligned with the side walls corresponding to an open state of
the reservoir allowing blood flow from the reservoir onto a test
strip of the testing assembly.
22. A device for use in a blood test, the device comprising a
finger holding element configured to be fit on the finger such as
to apply certain pressure to the finger, said finger holder
comprising a band operable to be shifted from its open inoperative
position to a closed-loop operative position in which it fits the
finger, said band when in the operative position thereof applies
the pressure to the finger while preventing over-pressing of the
finger, thereby reducing pain associated with the blood test.
23. A device according to claim 22, comprising a cap-like element
configured to accommodate at least a portion of the finger and
defining a distal end comprising a contact surface and a proximal
end being connected to a portion of said band.
24. A system: (i) the blood test device according to claim 1; and
(ii) a measurement device for non-invasively measuring one or more
body parameters.
25. A system according to claim 24, wherein measurement device is
configured and operable for non-invasive measurement of a blood
glucose.
26. A system according to claim 24, wherein said measurement device
is adapted to perform at least one of the following measurements:
an optical measurement, an impedance-type measurement, a
photo-acoustic measurement and an ultrasound tagging-based
measurement.
27. A system according to claim 25, wherein the measurement device
comprises a ring-shaped sensor.
28. A system according to claim 27, wherein the ring-shaped sensor
is adapted to be placed on the finger in addition to a finger
holding element for use in the blood test.
29. A system according to claim 28, wherein the measurement device
comprises a finger encompassing element for applying pressure to
the finger.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to devices and
methods for blood sampling and more specifically to devices and
methods for reduced-pain blood sampling.
BACKGROUND OF THE INVENTION
[0002] There are many instances in which a person must undergo body
fluid sampling. Medical practitioners often require full blood
analyses to assist in the diagnosis of a disease or condition.
Diabetics, for example, must monitor their blood sugar a number of
times a day. The removal or blood from a human body is normally
performed invasively and tends to be painful, leading to
procrastination and non-compliance of the patients. Moreover, in
children and babies, the invasive procedures are more difficult and
less effective. There is therefore a need to develop both less
painful invasive procedures and non-invasive procedures for blood
and other body fluid removal.
[0003] Some devices and methods for invasive blood sampling are
described in the art, inter alia, U.S. Pat. No. 6,045,567 describes
a lancing device, having a spring-loaded lancet holder slidably
mounted within a housing for carrying a disposable lancet and
needle. A knob on the back of the device has forward-extending
fingers that stop the lancet holder at an adjustable predetermined
point after the device has been fired. The fingers not only control
the penetration depth of the needle, but also absorb vibrations and
reduce noise to cause less pain to the user.
[0004] US Patent Application Publication No. US2005038463 describes
a device for providing transcutaneous electrical stimulation (TENS)
to the finger of a patient at the same time that the finger is
being punctured for the purpose of obtaining a blood sample. The
device should reduce the pain associated with this procedure and
should be of particular interest to diabetic patients that must
perform repeated finger puncture procedures to monitor blood
glucose levels.
[0005] US Patent Application Publication No. US2005234486 describes
an apparatus for extracting bodily fluid (e.g., whole blood) from a
user's finger includes a housing with a lancing mechanism and a
clamping mechanism attached to thereto. The clamping mechanism
includes a lower arm assembly and an upper arm assembly. The upper
and lower arm assemblies are operatively connected such that when a
user's finger applies a user force to the lower arm assembly and
displaces the lower arm assembly from a first to a second position,
the upper and lower arm assemblies cooperate to engage the user's
finger with a compressive force that is greater than the user
force. In addition, the lancing mechanism is configured to lance a
target site on the user's finger while the upper and lower arm
assemblies are cooperating to engage the user's finger. Thereafter,
the compressive force serves to extract a bodily fluid sample from
the lanced target site.
[0006] US Patent Application Publication No. US2006224085 describes
a method for collecting small amounts of blood sample by painless
puncture of a finger. When puncture of skin of a human being by a
needle or another device is performed at the depth of no more than
0.5 mm, pain accompanied by the puncture is diminished or
decreased. Regardless of an error in the depth of the puncture, the
depth of puncture always needs to not exceed this depth. The site
of puncture is the dorsal surface of a finger, that is, the area
from finger joint (IP joint of thumb, DIP joint of fingers other
than thumb) to proximal nail wall and the area extending from
proximal nail wall to lateral nail wall.
[0007] Some devices and methods for non-invasive blood sampling are
described in the art, inter alia, U.S. Pat. No. 6,400,972 describes
an over-systolic pressure, which is applied to a patient's blood
perfused fleshy medium. The pressure causes a state of temporary
blood flow cessation within a time period insufficient for
irreversible changes in the fleshy medium. Release of the over
systolic pressure causes a state of transitional blood flow
terminating with the normal blood flow. At least two sessions of
measurement, separated in time, are executed and at least one of
these sessions is selected within the time period including the
state of temporary blood flow cessation and the state of
transitional blood flow. Optical non-invasive measurement of the
concentration of at least one blood constituent are successively
performed at these at least two sessions, and respective values of
the concentration are obtained.
[0008] US Patent Application Publication No. US2004249252 describes
a method and device for use in non-invasive optical measurements of
at least one desired characteristic of patient's blood. A condition
of artificial blood kinetics is created at a measurement location
in a patient's blood perfused fleshy medium and maintained for a
certain time period. This condition is altered over a predetermined
time interval within said certain time period so as to modulate
scattering properties of blood. Optical measurements are applied to
the measurement location by illuminating it with incident light
beams of at least two different wavelengths in a range where the
scattering properties of blood are sensitive to light radiation,
detecting light responses of the medium, and generating measured
data indicative of time evolutions of the light responses of the
medium for said at least two different wavelengths, respectively,
over at least a part of said predetermined time interval.
[0009] US Patent Application Publication No. US2007043281 describes
a method and system for non-invasive measurements in a patient's
body in which several measurement sessions are performed on a
measurement location. Each measurement session includes applying an
external electromagnetic field to the measurement locations,
detecting at least two responses of the measurement location, and
generating data indicative of the detected response. These
responses are characterized by at least two different values of a
controllable parameter. The measurement sessions include at least
two measurement sessions carried out at a normal blood flow in the
measurement location and at least two measurement sessions carried
out at a condition of artificial kinetics in the measurement
location. The first and second measured data are processed to
determine a first relation between the first time variations and a
second relation between the second time variations for the
different parameter that can be used to determine the at least one
blood related parameter.
[0010] US Patent Application Publication No. US2008262324 describes
an efficient approach of attaching and fixing a measurement head
for a spectroscopic system to a variety of different parts of the
skin of a patient. The measurement head preferably features a
compact design providing a flexible handling and offering a huge
variety of application areas taking into account the plurality of
properties of various portions of the skin. Furthermore, the
measurement head features a robust and uncomplicated optical design
not requiring a lateral shifting of the optical axis of the
objective. Such transverse relative movements between the objective
and a capillary vessel in the skin are preferably performed by
mechanically shifting the skin with respect to the objective of the
measurement head. Moreover, the measurement head is adapted to host
one or more pressure sensors measuring the contact pressure between
the measurement head and the skin. This pressure information can
further be exploited in order to calibrate the spectroscopic
analysis means, to regulate the contact pressure within predefined
margins specifying an optimum range of contact pressure for
spectroscopic examination of capillary vessels.
[0011] Most of the non-invasive devices in the art require
occasional calibration involving invasive blood sampling. There is
therefore a need to provide systems, devices and methods for blood
sampling which overcome the limitations and disadvantages of the
devices and methods described hereinabove.
GENERAL DESCRIPTION
[0012] There is a need in the art in a medical device for a blood
test, which is on the one hand portable and easy to operate (e.g.
by user himself) to perform a full and accurate test of a desired
condition of blood, and on the other hand reduce pain associated
with the blood test procedures.
[0013] The present invention meets the above goals by providing a
novel device for the blood test, as well as a blood finger holding
element which may be a stand-alone unit.
[0014] With regard to the pain reduction aspect of the invention,
it should be understood that "pain" has both psychological and
physical factors. The device of the present invention is configured
such that it on the one hand hides an operation of a finger
piercing assembly from the user (thus reducing the psychological
factor), and on the other hand allows for appropriately applying
pressure to the finger (i.e. pressure value control and positioning
of a pressurized location) to thereby reduce the physical effect of
pain.
[0015] The device of the present invention may be fully integrated
with respect to all the necessarily elements for performing the
test: piercing assembly, sampling assembly and testing assembly.
Moreover, the device of the present invention provides for a
passive extraction of a blood sample from the finger, namely the
finger may be kept static during the entire test procedure, while
all the elements for piercing, sampling and testing modes are
orderly brought into operation (e.g. brought to the desired
location with respect to the finger and actuated). The device is
preferably configured to be in a stable state eliminating a need
for holding the device by the second hand of the same user or
another assistant. Furthermore, the device of the present invention
provides for controlling the collection of the desired volume of
blood for the test, i.e. sufficient amount of blood on the one hand
and not exceeding the predetermined volume to suit the testing
reagents being used.
[0016] Thus, according to one broad aspect of the invention, there
is provided a medical device for a blood test, the device
comprising:
[0017] i. a housing defining a finger site for supporting a user's
finger or a portion thereof within said finger site during the
device operation;
[0018] ii. piercing, sampling and testing assemblies sequentially
actuatable to successively initiate piercing, sampling and testing
operational modes of the device;
[0019] iii. a carriage at least partially accommodated within said
housing and being adapted for movement with respect to said finger
site between its first position corresponding to the piercing mode
of the device and a second position corresponding to the sampling
and testing modes of the device, the device being thereby capable
of operating in the piercing, sampling and testing modes while at a
static position of the user's finger.
[0020] The piercing assembly may be accommodated inside the housing
with respect to the finger site such that an operation of the
piercing assembly in the piercing mode of the device is hidden from
the user.
[0021] The device may comprise a finger holding element, which as
indicated above may be stand-alone unit separate from said housing.
The finger holding element is configured to be fit on the finger
such as to apply pressure to the finger in a manner assisting in
withdrawal of blood during the piercing and sampling modes and
reducing pain associated with the blood test.
[0022] In some embodiments, the finger holder comprises a band
operable to be shifted from its open inoperative position to a
closed-loop operative position in which it fits the finger. The
band when in the operative position thereof applies the pressure to
the finger while preventing over-pressing of the finger, thereby
reducing pain involved in the blood test procedures.
[0023] In some other embodiments, the finger holder element is
configured to be fit on the finger such as to apply pressure to a
certain location on the finger, wherein this certain location is
selected to be spaced a predetermined distance from the finger tip
and/or a piercing orifice provided in the finger site. This can be
implemented by providing a groove in the housing located within the
finger site and being configured for immobilizingly receiving a
portion of the finger holder element therein. By this, a position
of the finger with respect to said finger site is fixed during the
device operation. The groove is also located at a predetermined
distance from the piercing orifice, thereby ensuring the
application of pressure to the finger by said finger holder element
a certain predetermined distance from a location on the finger
being pierced.
[0024] Optionally, said housing includes a protrusion defining a
distal end of the finger site to be abutted by a finger tip during
the device operation. In this case, a finger holding element
configured to be fit on the finger to apply pressure to a location
on the finger corresponding to that spaced a predetermined distance
from the protrusion, which is located a predetermined distance from
a piercing orifice provided in said finger site.
[0025] Preferably, the piercing assembly comprises a piercing
element movable along a first axis (typically vertical axis)
towards and away from the finger site, and accessing the finger via
an orifice in said finger site to perform piercing. The piercing
assembly may be stationary mounted in the housing or may be movable
by said carriage along a second axis (typically horizontal axis)
intersecting with the first axis, with respect to the finger site,
between its first inoperative position and second operative
position. In the first inoperative position, the piercing element
is not aligned with the orifice along the first axis, and in the
second operative position it is aligned with said orifice along the
first axis.
[0026] Preferably, the sampling assembly comprises a blood holding
element for collecting a predetermined volume of a liquid-phase
blood sample flowing from the finger as a result of piercing. The
blood holding element may be configured such that, when in the
sampling mode of the device, the blood holding element has a top
portion formed with a projecting sloped member for flowing a
portion of collected blood volume above said predetermined volume
out of a hollow liquid reservoir towards an indication window,
appearance of blood in the indication window being indicative of
that the blood holding element contains the predetermined volume of
blood. This means that the top portion may be part of the liquid
reservoir, or the blood holding element is two-part element, the
first, bottom part being said liquid reservoir, and the second top
part being removably mountable onto the reservoir thereabove. Thus,
generally, if provision of the projecting sloped member is
considered, it may be associated with the removable top part of the
two-part blood holding element or with the top portion of the
single-part blood holding element (reservoir).
[0027] Considering the two-part form of the blood holding element,
the second top part thereof may be movable between its inoperative
position being separated (dissembled) from the reservoir and its
operative, assembled position forming the top portion of the blood
holding element. Displacement of the top portion from the assembled
position into the dissembled position might also serve for removing
excess blood from the reservoir.
[0028] In some embodiments, the liquid reservoir comprises a bottom
plate movable between its first and second positions. In the first
position, the bottom plate is aligned with side walls of a
generally cylindrically shaped reservoir, corresponding to a closed
state of the reservoir keeping collected blood in the reservoir. In
the second position, the bottom plate is misaligned with the side
walls corresponding to an open state of the reservoir allowing
blood flow from the reservoir onto a test strip of the testing
assembly.
[0029] As indicated above, the testing assembly includes a test
strip. The latter may be insertable into a slot made in said
housing in a manner enabling sliding movement of the test strip
towards and away from a location of alignment with the piercing
orifice, i.e. corresponding to the testing mode.
[0030] The configuration may generally be such that the test strip
is selectively insertable into a position in which a portion
thereof is aligned with said liquid reservoir (which might
correspond to alignment with a piercing orifice) to receive a blood
sample from the finger after piercing.
[0031] In some embodiments of the invention, the movable carriage
incorporates or is connected to elements of the piercing, sampling
and testing assemblies such that the movement of the carriage with
respect to the finger site successively brings said elements into
different operative positions corresponding to said first and
second positions of the carriage. In each of such operative
positions, the element of the respective assembly is aligned with
the finger site.
[0032] The device may also comprise a reagent holding unit mounted
for movement such as to be selectively brought into alignment
position with respect to an element of the testing assembly (e.g.
test strip), when in the testing mode of the device.
[0033] According to another broad aspect of the invention, there is
provided a medical device for a blood test, the device comprising:
a housing defining a finger site for supporting a user's finger or
a portion thereof within said finger site during the device
operation, and piercing, sampling and testing assemblies at least
partially accommodated in said housing, wherein
[0034] the piercing assembly comprises a piercing element movable
towards and away from the finger site accessing the finger via an
orifice in said finger site to perform piercing;
[0035] the sampling assembly comprises a blood holding element,
which comprises a hollow liquid reservoir for collecting blood
freely flowing from the orifice, said liquid reservoir comprising a
bottom plate movable between its first position, in which it is
aligned with side walls of the reservoir, corresponding to a closed
state of the reservoir keeping collected blood in the reservoir,
and a second position, in which it is misaligned with the side
walls corresponding to an open state of the reservoir allowing
blood flow from the reservoir onto a test strip of the testing
assembly.
[0036] According to yet further broad aspect of the invention,
there is provided a device for use in a blood test, the device
comprising a finger holding element configured to be fit on the
finger such as to apply certain pressure to the finger, said finger
holder comprising a band operable to be shifted from its open
inoperative position to a closed-loop operative position in which
it fits the finger, said band when in the operative position
thereof applies the pressure to the finger while preventing
over-pressing of the finger, thereby reducing pain associated with
the blood test.
[0037] Such device may comprise a cap-like element configured to
accommodate at least a portion of the finger and defining distal
and proximal ends, where the distal end has a contact surface, and
the proximal end is connected to a portion of said band.
[0038] According to some embodiments of the invention, there is
thus provided an invasive reduced-pain blood sampling and testing
device for self-sampling from a static immobilized finger, the
device including;
[0039] a) a horizontally-disposed finger support element configured
to support the finger thereupon;
[0040] b) a finger holding element adapted, in a closed position,
to radially grip the finger on the support element near to a tip
thereof and configured to force blood into the tip;
[0041] c) a lancet housing element disposed vertically underneath
the finger support element for piercing the finger tip with a
lancet while the finger tip is gripped by the finger holding
element and supported by the finger support element; and
[0042] d) a test strip conveying element adapted to be received by
the finger support element after retraction of the lancet housing
element thereby bringing a test strip into direct contact with a
predetermined volume of blood from the finger support element
thereby effecting a blood test.
[0043] Furthermore, according to an embodiment of the present
invention, the horizontally-disposed finger support element further
includes a finger straightening element disposed towards a distal
end thereof.
[0044] Additionally, according to an embodiment of the present
invention, the horizontally-disposed finger support element further
includes an aperture at a proximal end thereof for receiving and
supporting the test strip conveying element.
[0045] Moreover, according to an embodiment of the present
invention, the horizontally-disposed finger support element further
includes a blood holding element for receiving blood from the
finger tip.
[0046] According to some embodiments, the blood holding element is
adapted to contact the test strip after retraction of the lancet
housing element. In some cases, the volume of blood is a
predetermined according to a volume of the blood holding
element.
[0047] Additionally, according to an embodiment of the present
invention, the horizontally-disposed finger support element further
includes a reagent holding unit.
[0048] Moreover, according to an embodiment of the present
invention, the reagent holding unit is adapted, in a test position,
to be aligned vertically above the test strip.
[0049] According to some further embodiments, the finger holding
element further includes an elastic element for applying radial
pressure to the finger tip. The elastic element may be adapted to
force blood out of the finger tip upon activation of the lancet.
Additionally, the elastic element may be adapted to reduce or
prevent pain during the blood sampling.
[0050] The invention, in its yet further aspect, provides a system
comprising the above-described blood test device and a measurement
device for non-invasively measuring one or more body
parameters.
[0051] The measurement device may be configured and operable for
non-invasive measurement of blood glucose. This may be performed
using at least one of the following measurements: an optical
measurement, an impedance-type measurement, a photo-acoustic
measurement and an ultrasound tagging-based measurement.
[0052] The measurement device may comprise a ring-shaped sensor,
which may for example be placeable on the finger in addition to a
finger holding element for use in the blood test. The measurement
device may comprise a finger encompassing element for applying
pressure to the finger.
[0053] Further, according to an embodiment of the present
invention, the test may be selected from a group consisting of a
test for biological factors associated with cholesterol; a test for
assessing heart disease risk; a glucose test for monitoring
diabetes; a test for the presence of illegal drugs; a test for drug
abuse; a test for hCG pregnancy testing; a test for an HIV-antibody
for determining HIV infection or other infectious diseases, a
prothrombin time test for monitoring blood thinning and clotting; a
test for fecal occult blood for screening for colorectal cancer or
other cancer related tests; a test for luteinizing hormone for
determining ovulation, or a combination thereof.
[0054] In one embodiment, the test is accomplished by piercing the
skin with a lancet integrated into the body of the unit. Pulling
back a lever (the `operating button`) activates the spring-loaded
lancet, which pierces the skin and then retracts immediately. The
same lever pushes a `pressing element`, a rubber ring, a clamp or
any other pressure-generating element, preferably at least
partially made of solid plastic or rubber; forceful acoustic wave,
energized light beam etc, against the finger that increases the
blood pressure in the finger, ensuring a sufficient but small
amount of blood leaves the finger. This blood is immediately
absorbed by a capillary sponge that conducts the blood onto a
testing strip impregnated with blood-testing reagents of various
sorts. Additionally, this capillary sponge may act as a reservoir
to collect a predetermined volume of blood required for the
performance of the diagnostic test. The testing strip provides the
test result by way of a color change that indicates a positive or
negative test result.
[0055] In another preferred embodiment of the present invention,
the device comprises a small disposable unit equipped with a recess
to fit a human finger; a spring-loaded lancet that pierces the
finger and immediately retracts; a capillary sponge into which a
predetermined measure blood, e.g., 0.1 to 150 microliter, from the
finger is absorbed; a testing strip impregnated with blood-testing
reagents of various sorts onto which blood from said capillary
sponge is conveyed by means of capillary action; a results-viewing
window in which the results of the blood test(s) is/are displayed
by means of color changes in said reagents of said testing strip; a
pressing element (e.g., a sponge) that presses against the finger
to increase local blood pressure ensuring extraction of blood; and
an operating button in mechanical communication with the lancet and
the pressing element such that pushing the operating button
increases blood pressure gradually and activates the lancet at the
end of the operating button's travel.
[0056] The present invention relates to an integrated sampling and
testing device for sampling and testing blood from a human finger,
comprising a clamping means for temporarily clamping a finger below
the tip of the finger, so as to increase the volume of blood at the
finger tip and thereby facilitate drawing of blood from said
finger; a lancet for piercing the finger tip while the finger is
held by said clamping means; and, a testing means for performing at
least one test on blood drawn from the finger.
[0057] The testing means is aligned with the lancet such that blood
drawn from the finger immediately contacts the testing means after
being drawn from the finger tip. Thus, the user is provided with a
single device for easily and effectively drawing and testing blood.
The user does not need to perform any steps in order to transfer
blood from the lancet to the testing means. Rather, because of the
arrangement and configuration of the lancet and the testing means,
blood that is extracted/withdrawn at the finger tip following
piercing of the skin is conveyed directly onto the testing
means.
[0058] In one preferred embodiment, the testing means are
positioned at least partially in between the lancet and the
clamping means, the testing means includes an opening for allowing
the piercing means of the lancet to pass therethrough at the time
of pricking of the finger. Thus, the blood droplets drip directly
onto the testing means. Additionally or alternatively, a capillary
sponge embedded in the lancet adsorbs the blood so that the blood
travels by capillary action to the testing means.
[0059] Preferably, the testing means comprises a test strip, as are
well-known in the art. The test strip preferably includes a housing
and a capillary sponge located inside of the housing. In some
preferred embodiments of the present invention, the housing is
provided with a blood volume window for indicating when sufficient
blood has been drawn for the particular test, and a test results
window for indicating the results of the test. The results window
preferably includes a control indicator and a test indicator. The
test indicator may include any number of lines, such as between one
and three. The results may be quantitative, qualitative, or
semi-qualitative.
[0060] In some preferred embodiments, reagent transferring means
are provided for transferring a predetermined amount of at least
one reagent to the testing means after blood has been drawn from
the finger. The reagent transferring means preferably includes at
least one reagent and at least one container for holding a reagent
therein. A syringe-like piston may be provided for pushing the
reagent out of an orifice located at the end of the reagent
container. It will be appreciated that other reagent transferring
means could also be employed for directly conveying at least one
reagent to the testing means. It will also be appreciated that in
some tests, a reagent is not required whereas in other tests, one
or more reagent may need to be added in order for the test to be
properly performed.
[0061] Preferably, the lancet comprises piercing means, and a
lancet housing for housing the piercing means. The lancet housing
also comprises an orifice located at the top portion thereof for
allowing the piercing means to temporarily protrude from the
housing so as to enable finger piercing. Many varieties of lancets
are known in the art which may be employed. The piercing means may
be, for example, a needle or a small scalpel.
[0062] According to preferred embodiments of the present invention,
the lancet housing further comprises a lateral opening positioned
directly below the top portion thereof for receiving at least a
portion of the test strip. In one preferred embodiment, the test
strip has an opening therein for allowing the piercing means to
pass therethrough at the time of blood sampling. In this preferred
embodiment, blood drawn from the finger tip using the piercing
means automatically drips back down into the lancet orifice and
onto the test strip.
[0063] Alternatively, the lancet is provided with a capillary
sponge and optionally, a pressing element, that serves to apply
mild pressure to the finger following piercing such that a
sufficient amount of blood becomes absorbed by the capillary sponge
and conveyed to the testing means in communication with the
capillary sponge.
[0064] According to preferred embodiments of the present invention,
the clamping means comprises a clip mechanism having a proximal end
and a distal end. The proximal end includes a radially-expandable
clamping member adapted for accommodating the end of a finger
therein. The distal end includes a handle for actuating the
radially-expandable clamping member such that the clamping member
can be radially expanded and contracted around the finger for
increasing local pressure thereby facilitating blood withdrawal
following finger piercing. When contracted around the finger, the
clamping member applies pressure to the finger such that the region
of the finger which is adjacent to the clamping finger contains a
high volume of blood. It will be appreciated that the clamping
member is adapted for preventing backflow of blood to the body.
This makes drawing of blood easier, since it makes it unnecessary
to apply additional pressure to ensure that blood flows from the
finger tip after piercing. Preferably, the radially-expandable
clamping member comprises a flexible tourniquet having the
configuration of a ring or a sleeve. It will be appreciated that
other configurations are also possible. Any suitable elastic or
other pressure generating material or mechanism may be used for the
clamping member.
[0065] Any suitable mechanism may be employed for providing radial
expansion of the clamping member. In one embodiment, for example,
the clamping member is connected to the handle by three connection
members equally-spaced around the circumference of the clamping
member. When the handle is actuated, the connection members are
pulled outward, thereby causing the clamping member to expand
radially. Preferably, the handle includes two opposing hand grips
and the proximal and distal end are hinged by at least one springed
joint. In this manner, pressing the hand grips causes the clamping
member to open to allow the user to insert the finger. Releasing
the grip on the hand grips causes the clamping member to close
around the finger. It is appreciated that the use of such a
clamping member allows for blood sampling from fingers of a wide
range of sizes.
[0066] It is appreciated that the device of the present invention
may be manufactured for one-time usage only, after which it is
disposed of Alternatively, the device of the present invention may
be manufactured such that only the test strip is disposed of after
each use.
[0067] The present invention also relates to an integrated sampling
and testing device for sampling and testing blood from a human
finger. The device includes a lancet for piercing the tip of a
finger, and testing means for performing at least one test on blood
drawn from the finger. The testing means is aligned with the lancet
such that blood drawn from the finger immediately contacts the
testing means after being drawn from the finger tip. Thus, the user
is provided with a single device for easily and effectively
withdrawing and testing blood. The user does not need to perform
any steps in order to transfer blood from the lancet to the testing
means. Rather, because of the arrangement and configuration of the
lancet and the testing means, blood that is produced at the finger
tip following piercing of the skin is conveyed directly onto the
test strip. In one scenario, the blood simply drips onto the test
strip by means of surface tension or gravity. In another scenario,
a capillary sponge embedded in the lancet adsorbs the blood so that
the blood travels by capillary action to the testing means. In yet
another scenario, suction is applied to facilitate blood transfer
to the test strip.
[0068] According to preferred embodiments of the present invention,
the testing means comprises a test strip. The test strip may
include housing and a capillary sponge located inside of the
housing. In some embodiments of the present invention, the housing
is provided with a blood volume window (indicating window) for
indicating when sufficient blood has been drawn for the particular
test, and a test results window for indicating the results of the
test. The results window preferably includes a control indicator
and a test indicator. The test indicator may include any number of
indication lines, such as between one and three. The results may be
quantitative, qualitative, or semi-qualitative.
[0069] Further according to preferred embodiments of the present
invention, the lancet housing further comprises a lateral opening
positioned directly below the top portion of the housing for
receiving at least a portion of the test strip. The test strip has
an opening therein for allowing the piercing means to pass
therethrough at the time of blood sampling, such that blood drawn
from the finger tip using the piercing means automatically drips
down onto the test strip.
[0070] The present invention also relates to a clamping unit for
use in combination with a blood sampling device, for increasing the
blood volume and/or pressure at the finger tip and thereby
facilitating blood sampling. The clamping unit includes a clip
mechanism having a proximal end and a distal end. The proximal end
comprises a radially-expandable clamping member adapted for
receiving the end of a finger therein, and the distal end comprises
a handle for actuating a radially-expandable clamping member, such
that when the handle is pressed by the user, the clamping member
opens to allow insertion of the finger. When the handle is
released, the clamping member closes so as to apply pressure onto
the finger, thereby increasing blood volume and/or pressure at the
finger tip.
[0071] Preferably, the radially-expandable clamping member
comprises a flexible tourniquet having a configuration of a ring or
a sleeve.
[0072] The present invention further provides a device for self
sampling and testing blood in a human finger in a minimally painful
manner by inducing a Distracting Volume Coefficient (DVC) lower
than 5 said device comprising clamping means for temporarily
clamping a finger below the tip of said finger, said clamping means
comprising a radially expandable clamping member and means for
expanding and contracting said member; a lancet for piercing said
finger tip while said finger tip is held by said clamping member,
testing means for performing at least one test on blood drawn from
said finger; wherein said radially expandable clamping member
adapted to clamp the finger to a predetermined DGF and said lancet
adapted such that blood volume (BV) drawn from said finger
immediately contacts said testing means after being drawn wherein
DGF.BV is below 5, further wherein patient reported pain during
said sampling is less than 1 on the Wong-Baker scale.
[0073] The present invention will be more fully understood from the
following detailed description of the preferred embodiments
thereof, taken together with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0074] The invention will now be described in connection with
certain preferred embodiments with reference to the following
illustrative figures so that it may be more fully understood.
[0075] With specific reference now to the figures in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of the preferred embodiments of
the present invention only and are presented in the cause of
providing what is believed to be the most useful and readily
understood description of the principles and conceptual aspects of
the invention. In this regard, no attempt is made to show
structural details of the invention in more detail than is
necessary for a fundamental understanding of the invention, the
description taken with the drawings making apparent to those
skilled in the art how the several forms of the invention may be
embodied in practice.
[0076] In the drawings:
[0077] FIG. 1A is a simplified pictorial illustration of a front
view of a compact whole-blood sampling and testing device, in
accordance with an embodiment of the present invention;
[0078] FIG. 1B is a simplified pictorial illustration of a side
view of a compact whole-blood sampling and testing device, in
accordance with an embodiment of the present invention;
[0079] FIG. 1C is a simplified pictorial illustration of a
sectional view of a compact whole-blood sampling and testing
device, in accordance with an embodiment of the present
invention;
[0080] FIG. 2A is a simplified pictorial illustration of a
perspective view of a compact whole-blood sampling and testing
device in an open position, in accordance with an embodiment of the
present invention;
[0081] FIG. 2B is a simplified pictorial illustration of a
perspective view of a compact whole-blood sampling and testing
device in a closed position, in accordance with an embodiment of
the present invention;
[0082] FIG. 2C is a simplified pictorial illustration of a vertical
section of a compact whole-blood sampling and testing device in a
closed position, in accordance with an embodiment of the present
invention;
[0083] FIG. 3A is a simplified pictorial illustration of a
horizontal section of a compact whole-blood sampling and testing
device in a pre-test position, in accordance with an embodiment of
the present invention;
[0084] FIG. 3B is a simplified pictorial illustration of a
horizontal section of a compact whole-blood sampling and testing
device in a test position, in accordance with an embodiment of the
present invention; and
[0085] FIG. 4 is a simplified pictorial illustration of a
perspective view of a hybrid system for whole-blood sampling and
testing, in accordance with an embodiment of the present
invention.
[0086] FIGS. 5A-5J: FIG. 5A is a cross-sectional view of an
integrated device for blood piercing, sampling and testing
illustrating the device in a sampling/testing position; FIG. 5B is
a similar cross-sectional view of the integrated device for blood
piercing, sampling and testing illustrating the device in a
piercing position; FIG. 5C is a side cross-sectional view of the
device while in its sampling position; FIG. 5D is a side
cross-sectional view of the device in a testing position thereof;
FIG. 5E shows another cross-sectional view of the device while in
the sampling/testing position; FIG. 5F is an isometric view of the
device; FIG. 5G is a top view of the device showing lines A-A, B-B,
E-E along which the sectional views of FIGS. 5A, 5E and 5C
respectively are taken; FIG. 5H shows the similar top view of the
device also showing line D-D along which the section view of FIG.
5D is taken, and a testing means; FIG. 5I is an isometric view of
the device showing a finger positioned on the finger support
element; and FIG. 5J is an exploded view of the device.
[0087] FIGS. 6A-6J exemplify a finger holder assembly of the
present invention suitable to be used with the integrated device of
the present invention: FIGS. 6A-6D correspond to an opened position
of the assembly (before fitting the finger), where FIG. 6A shows a
front isometric view of the finger holder assembly; FIG. 6B
illustrates more specifically the configuration of a cap-like part
of said, circle "B" showing the locking loop interior; FIG. 6C is a
magnified isometric view of the locking loop; FIG. 6D shows a back
isometric view of the finger holder assembly; FIGS. 6E-6H
correspond to a closed (ring-like) position of the finger holder
assembly: FIG. 6E is a front, magnified isometric view of the
assembly; FIGS. 6G and 6F show a back isometric view of the
assembly, where in FIG. 6G the locking loop element is show in a
sectional view to show more specifically the locking mechanism;
FIG. 6H is an enlarged view of the locking mechanism of FIG. 6G;
FIGS. 6I-6J show the finger holder assembly while being fitted on a
user's finger.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0088] In the detailed description, numerous specific details are
set forth in order to provide a thorough understanding of the
invention. However, it will be understood by those skilled in the
art that these are specific embodiments and that the present
invention may be practiced also in different ways that embody the
characterizing features of the invention as described and claimed
herein.
[0089] Reference is now made to FIG. 1, including FIGS. 1A-1C,
which are simplified pictorial illustrations of a front view, side
view and section, respectively, of a compact whole-blood sampling
and testing device 100, in accordance with an embodiment of the
present invention. The device 100 is configured as an integrated
device for successively carrying out piercing, blood sampling and
testing procedures.
[0090] Two plastic strips 11, perpendicular to and above a
vertically disposed body 24 of the device, constitute the finger
holder, and are joined by a button 10 at each end thereof. The
upper plastic strip may also contain a reagent compartment 12 (not
shown), which contains a quantity of a specific chemical that
reacts with the blood or some component therein as part of the
therapeutic test. The test is accomplished by release pressing a
button 17 that causes release of a spring-loaded lancet 18 (along
with reagent, if any, from the reagent compartment 12) in the
interior of the device. After the lancet is released, the blood may
be absorbed by a capillary sponge 30, which transfers the blood to
a test strip 14 at the side of the device via capillary action. An
indication window 15 is provided as a means of confirming that the
blood sample has reached the test strip and that a sufficiently
large volume of blood has been drawn to permit accurate testing.
The test results are then monitored via observation of the test
trip through the result window 16.
[0091] In an embodiment of the present invention, the device
includes an elastic band 20 that fits around person's finger. The
elastic band is connected via connector elements 22 to the two
plastic strips 11. The two plastic strips are joined at their ends
such that they hold the elastic band in place before the finger is
inserted, and exert a slight pressure upon the elastic band and the
finger after its insertion into the elastic band. At each of the
two places where the plastic strips join, a side button is attached
such that application of pressure simultaneously to the two buttons
causes the plastic strips to separate, allowing the finger to be
released from the elastic band. Test strip 14 may be a
colorimetric, fluorometric, electronic or other testing strip. The
test is accomplished by piercing the skin with the lancet, which is
integrated into the body of the unit. Pulling back a lever (the
`operating button` 17) activates the spring-loaded lancet, which
pierces the skin and then retracts immediately. The same lever
pushes a `pressing element` against the finger that increases the
blood pressure in the finger, ensuring a sufficient but small
amount of blood leaves the finger. This blood is absorbed by a
capillary sponge that may act according a specific embodiment of
the invention as a reservoir to collect a predetermined volume of
blood required for the test.
[0092] The capillary sponge may further be impregnated with, coated
by or composed of blood-testing reagents of any sort. Alternatively
or additionally, blood-testing reagents may be stored in a reagent
compartment and delivered to the capillary sponge simultaneously
with the blood sample. Alternatively or additionally, the capillary
sponge further directs blood onto a testing strip, optionally
impregnated with blood-testing reagents of various sorts. The
testing strip provides the test result by way of a color change.
The device is small, lightweight, and inexpensive, and is intended
to be a disposable item that is used and then discarded.
[0093] It is in the scope of the present invention wherein the
capillary sponge serves as reservoir for collecting the volume of
blood required for the test. Nevertheless, another blood reservoir
or reservoirs are within the scope of the present invention.
[0094] The device is especially useful for diagnosing health
conditions based on determination of concentrations, conductivity,
viscosity, and the like of chemical and/or biological factors
selected in a non-limiting manner from cholesterol, for assessing
risk of heart disease; glucose, for monitoring diabetes; the
presence of illegal drugs and drugs of abuse; hCG, to screen for
pregnancy; HIV-antibody, for determining HIV infection; prothrombin
time, for monitoring blood thinning and clotting; fecal occult
blood, to screen for colorectal cancer; and luteinizing hormone, to
predict ovulation or any combination thereof.
[0095] Device 100 may according to some embodiments, require only a
simple colorimetric chemical reaction for its operation, and may
require no electricity or computer. However, in other modes of
detection, such as fluorometric, electronic, or any other
sensory-discernable signals are also within the scope of this
invention. Device 100 can be used anywhere, being lightweight,
portable, and disposable. It provides rapid and accurate diagnosis
based on exhaustively investigated biological, chemical or physical
reactions with whole blood that have been perfected by the medical
industry. Blood spillage is entirely avoided since the blood is
conveyed immediately after it is drawn onto the capillary sponge.
Similarly, the entire volume of blood required is minimized,
eliminating the health hazard of spillage and the psychological
factors involved with the sight of blood, in addition to decreasing
the physical pain associated with drawing a larger amount of
blood.
[0096] It is acknowledged in this respect that according to another
embodiment of the present invention, the plastic strips (in
conjunction with an elastic band) provide multiple effects, e.g.,
applying required pressure for enabling blood to be extracted,
acting to reduce the pain associated with lancet piercing, etc.
Blood is possibly extracted by the patient himself in a
semi-automatic passive manner, hence the possibility of
transferring blood-borne pathogens to Medicare personnel is reduced
or even entirely eliminated.
[0097] Reference is now made to FIGS. 2A-2C, which are simplified
pictorial illustrations of perspective views and a vertical
section, respectively, of a compact whole-blood sampling and
testing device 200 for a finger 220, in accordance with embodiments
of the present invention. Finger 220, such as an index finger,
comprises a nail 222, an upper segment 224 (or finger tip-beyond
the upper knuckle) having a fleshy pouch 226 on a lower side
thereof.
[0098] Device 200 comprises four major elements: a test strip
conveying element 210, a finger holding element 240 and a finger
support element 250. These elements are typically made out of a
plastic material.
[0099] According to one embodiment, test strip conveying element
210 is an elongate element having a roughly rectangular upper
surface 212, a T-shaped vertical cross-section 214 and a results
window aperture 216 on the upper surface at near to proximal end
218 thereof.
[0100] Test strip 208 may be any suitable diagnostic strip known in
the art, such as but not limited to a chemical test strip, a
colorimetric, fluorometric, electronic or other test strip.
[0101] Test strip conveying element 210 is designed to be received
by the finger support element 250. Finger support element 250
comprises an aperture 252 of suitable dimensions at a proximal end
254 thereof for receiving and supporting the test strip conveying
element 210 along a horizontal axis. The finger support element 250
may contain internal rails (not shown) upon which the test strip
conveying element may be moved, though other arrangements are
within the scope of the invention.
[0102] Lancet housing element 230 is disposed vertically underneath
the finger support element 250 and substantially perpendicularly
thereto. The lancet housing element 230 comprises a plastic handle
232, suitable for pushing vertically upwards, by the use of a thumb
or other finger. A lancet 234 protrudes upwardly from the lancet
housing element.
[0103] Finger holding element 240 is designed to hold the finger
below the upper segment. The finger holding element 240 is closed
and opened by means of a clasp 242. The clasp has a receiving
element 244 (FIG. 3A). The receiving element is adapted to receive
fingers of different sizes and close around them in tight fit by
means of grooves 246 on a lower side of the holding element. The
finger may be retained further by means of finger straightening
element 202, disposed towards a distal end 256 of the finger
support element 250. Finger straightening element 202 may be made
of a flexible or elastic material, or from a plastic material.
[0104] As can be seen in FIG. 2A, a finger may be introduced
through the finger straightening element 202, when clasp 242 is in
an open position. Thereafter the clasp may be closed around the
finger.
[0105] Reference is now made to FIG. 3A, which is a simplified
pictorial illustration of a horizontal section 300 of the compact
whole-blood sampling and testing device 200 in a pre-test position,
in accordance with an embodiment of the present invention.
[0106] Clasp 240 houses within it an elastic element 204, such as
an elastic band, which is disposed around the finger at the upper
segment (near to the upper knuckle) in tight-fit. The elastic
element pressurizes the upper segment, forcing blood to accumulate
in the fleshy pouch thereof. The elastic element may be an integral
part of the device or may be provided separately therefrom.
[0107] Reference is also made to FIG. 3B, which is a simplified
pictorial illustration of a horizontal section 300 of a compact
whole-blood sampling and testing device in a test position, in
accordance with an embodiment of the present invention.
[0108] According to some embodiments, device 200 comprises a
reagent holding unit 270, disposed vertically above a blood holding
element 280, which, when in the test position is aligned above the
test strip. As can be seen from FIG. 2A, when in the pre-test
position, the blood holding element is disposed at a different
horizontal position, to the left/right of the reagent holding unit,
thus preventing direct contact between the reagent holding unit and
the test strip, as well as between the blood holding element and
the test strip. The blood holding element may be moved by means of
an engagement unit 260, which may be activated by a spring 262
disposed horizontally and perpendicularly to the engagement unit.
Many mechanisms may be used for activating the test by means of
aligning the blood holding element and the test strip. The example
shown in FIGS. 3A-3B should not be deemed limiting.
[0109] According to some embodiments, the device may be activated
with the following sequence of steps. [0110] 1. A finger is placed
through finger straightening element 202 and the finger holding
element 240 along and above the finger support element 250 and
inserted into the elastic element. [0111] 2. Clasp 242 is engaged
into the receiving element and is tightened to ensure accumulation
of blood in fleshy pouch 226. [0112] 3. After a few seconds, the
lancet housing element 230 is pressed upwards or activated by a
spring element (not shown), depending on the particular design
thereof. [0113] 4. The fleshy pouch is pierced by the lancet.
[0114] 5. Blood accumulates within the device, typically within
blood holding element 280. [0115] 6. Blood holding element 280 is
in fluid contact with a calibration window 284, which shows the
user when sufficient blood has accumulated for the purpose of the
test. [0116] 7. The user then retracts the lancet and releases his
finger by opening the clasp and withdrawing the finger from the
finger straightening element 202. In so doing, this brings forward
the test strip conveying element 210 from the position in FIG. 2A,
to a position as seen in FIG. 38. Simultaneously, the blood holding
element is moved from its position in FIG. 3A to the position in
FIG. 38 (aligned vertically below the reagent holding element and
above the test strip). Additionally, there may be a blood sampling
element 282, which limits the transfer of blood to the test strip
to a certain volumetric quantity (two drops, for example). There
may be a reagent measuring element 272 (not shown), which limits
the transfer of the reagent to the strip to be of a maximal
volumetric quantity. [0117] 8. The certain volumetric quantity of
blood then falls onto the test strip. [0118] 9. If a reagent is
required for the particular test, the maximal volumetric quantity
of the reagent falls onto the strip. It should be understood that
steps 8 and 9 may occur simultaneously or one before the other.
[0119] 10. Within a number of seconds the strip, blood and optional
reagent interact automatically thereby performing the test. [0120]
11. Thereafter, a test result appears in results window 216 on
strip 208.
[0121] According to further embodiments, the sequence of sub-steps
in step 7 hereinabove may be changed according to the configuration
and interaction between test strip conveying element 210, finger
holding element 240 and a finger support element 250.
[0122] FIG. 4 is a simplified pictorial illustration of a
perspective view of a hybrid system 400 for whole-blood sampling
and testing, in accordance with an embodiment of the present
invention.
[0123] Hybrid system 400 comprises a non-invasive body parameter
measuring device 410 and compact whole-blood sampling and testing
device 200 of the present invention. The non-invasive body
parameter device 410 may be any device performing non-invasive body
measurements, such as, but not limited to, pure optical
measurements, impedance-type measurements, photo-acoustic
measurements and ultrasound tagging based measurements. The
non-invasive body parameter device 410 typically suffers from a
need to be periodically calibrated using invasive measurements.
[0124] The non-invasive body parameter device 410, may, for
example, be a non-invasive blood glucose monitoring device, such
as, but not limited to, those produced by Orsense, Nes Ziona,
Israel (models NBM 200G or 2.sup.nd generation device) and/or
mentioned in the patent publications hereinabove.
[0125] The non-invasive body parameter device 410 typically
comprises a finger encompassing element 414, which may be flexible
or inflexible. Additionally, the device comprises a ring-shaped
sensor 412 for housing electronic components 417 (not shown) for
receiving signals and impulses from the finger. The device may
comprise one or more cuffs for introducing an over-pressure on the
finger. The device is, according to some embodiments, in wired
connection 416 with a monitor 420. Monitor 420 comprises a housing
422 with a display 424 and a number of monitor controls 426,
428.
[0126] For example, the NBM-200 Orsense model is based on OrSense's
proprietary Occlusion Spectroscopy technology. It combines
sensitive optical measurement (red/near-infrared
spectro-photometry, similar to pulse oximeters) with blood-flow
occlusion using a pneumatic finger cuff 414. The occluded blood
generates a strong optical signal, which enables highly sensitive
measurement of blood constituents. A ring-shaped sensor 412 is
fitted on the patient's finger. The ring gently pressurizes the
finger to over-systolic pressure, in a similar fashion as in blood
pressure measurement. A highly sensitive optical system, using an
array of calibrated light sources, measures light absorption and
scattering. A desktop monitor 420 calculates the results of the
test and displays the results on a display 424.
[0127] It should be understood that the hybrid system enables the
simultaneous use of non-invasive device 410 and device 200
(invasive). The arrangement in FIG. 4 should not be deemed
limiting. The non-invasive device may be placed further up the
finger than device 200 or vice versa. Additionally, the
non-invasive device may, in some cases, be placed around device
200.
[0128] The hybrid system 400 provides both the advantages of using
a majority of non-invasive measurements via device 410, as well as
limiting the pain of the patient in the essential invasive
calibration measurements using device 200. Device 200 of the
present invention provides a less painful invasive test than most
invasive devices known in the art. This is due to several design
features of the device. Namely,-- [0129] a) the use of the elastic
element 204 coupled with clasp 240 to force the blood into the
fleshy pouch of the finger tip; [0130] b) the immobilization of the
finger with finger straightening element 202, finger support
element 250, together with elastic element 204 coupled with clasp
240; [0131] c) the activation of the lancet housing element to
pierce the finger at the pouch in a way that the finger remains
passive.
[0132] Analysis of the pain exerted by device 200 relative to prior
art systems is now described. Some definitions used in the art
include:
[0133] The Wong-Baker pain scale is a tool that is used to help
health care providers diagnose or measure a patient's pain
intensity and uses cartoon faces with different expressions. These
are often useful when used with children. The Wong-Baker scale is a
relative scale of ascending pain defined in numbers from 0 toy, as
follows: 0=no pain; 1=hurts a little bit; 2=hurts quite a bit;
3=significant pain; 4=hurts a lot; and 5=terribly painful.
[0134] A Distracting Gate Force (DGF) is defined as the force
exerted by a radial clamping member during a self administered
blood sampling procedure below the tip of a finger. One unit of DGF
is defined as the force exerted by the radial clamping member
sufficient to reduce by the pain by one unit, as measured on the
Wong-Baker scale, as would have been perceived by the patient
without exertion of the force by the radial clamping member during
the blood sampling procedure.
[0135] Lancet Morphological Factor (LMF) is defined as a
multidimensional factor which combines lancet characteristics
including depth to which the lancet penetrates below the finger
during a self sampling operation in millimeters, location on the
finger to be pierced, geometry of tip, temperature of tip, hardness
of tip, conductivity of tip, stiffness of lancet shaft, spring-back
of lancet shaft, skin-tip contact time and other factors.
[0136] Distracting Lancet Coefficient ((DLC) is defined as the DGF
multiplied by the LMF. In any particular self-testing configuration
DGF.times.LMF defines a value associated with pain.
[0137] Blood Volume (BV) is hereinafter defined as the amount of
blood withdrawn in microlitres from a patient fingertip during a
single self sampling. The lower the volume drawn, the lower the
pain experienced (US Pharmacist Vol. No. 27:11 Posted Nov. 15, 2002
Monica Mehta, Pharm D et al)
[0138] Distracting Volume Coefficient (DVC) is defined as the DGF
multiplied by the BV. These are both variables associated with
pain. In any particular self testing configuration, DGF.BV defines
a value correlated with pain.
EXAMPLES
Example 1
[0139] A number of volunteers (6) in the age range of 30-60 were
asked to perform removal of blood using device 200 of the present
invention including elastic element 204 (elasticated device) and to
compare with tests excluding elastic element 204 (non-elasticated
device).
[0140] Each volunteer tested himself/herself without knowledge of
the results of the other volunteers in the group.
[0141] The results are tabulated in results Table 1.
TABLE-US-00001 TABLE 1 RESULTS OF PAIN OF INVASIVE BLOOD TEST USING
ELASTICATED VERSUS NON-ELASTICATED DEVICE VOLUNTEER VOLUNTEER
VOLUNTEER PAIN- WONG BAKER NO. DEVICE AGE GENDER SCALE 0-5 1
elasticated device 47 F 1 1 non-elasticated device 47 F 3 2
elasticated device 31 M 1 2 non-elasticated device 31 M 4 3
elasticated device 42 M 0 3 non-elasticated device 42 M 1 4
elasticated device 55 M 1 4 non-elasticated device 55 M 4 5
elasticated device 36 F 1 5 non-elasticated device 36 F 4 6
elasticated device 46 M 1 6 non-elasticated device 46 M 2 AVERAGE
elasticated device 42.8 0.83 AVERAGE non-elasticated device 42.8
3
[0142] As can be seen from Table 1, the average pain experienced by
the six volunteers using a non-elasticated device was 3
(significant pain) and the average pain experience using the
elasticated device 200 of the present invention was only 0.83
(hurts a little bit).
[0143] The references cited herein teach many principles that are
applicable to the present invention. Therefore the full contents of
these publications are incorporated by reference herein where
appropriate for teachings of additional or alternative details,
features and/or technical background.
[0144] It is to be understood that the invention is not limited in
its application to the details set forth in the description
contained herein or illustrated in the drawings. The invention is
capable of other embodiments and of being practiced and carried out
in various ways. Those skilled in the art will readily appreciate
that various modifications and changes can be applied to the
embodiments of the invention as hereinbefore described without
departing from its scope, defined in and by the appended
claims.
[0145] It is acknowledged in this respect that according to another
embodiment of the present invention, the plastic strips (in
conjunction with an elastic band) provide multiple effects, e.g.,
applying required pressure for enabling blood to be extracted,
acting to reduce the pain associated with lancet piercing, etc.
Blood is possibly extracted by the patient himself in a
semi-automatic passive manner, hence the possibility of
transferring blood-borne pathogens to Medicare personnel is reduced
or even entirely eliminated.
[0146] Device 200 of the present invention provides a less painful
invasive test than most invasive devices known in the art. This is
due to several design features of the device. Namely,-- [0147] d)
the use of the elastic element 204 coupled with clasp 240 to force
the blood into the fleshy pouch of the finger tip; [0148] e) the
immobilization of the finger with finger straightening element 202,
finger support element 250, together with elastic element 204
coupled with clasp 240; [0149] f) the activation of the lancet
housing element to pierce the finger at the pouch in a way that the
finger remains passive.
[0150] As previously stated herein above, the present invention
provides an integrated device including piercing, sampling and
testing assemblies; this integrated configuration allows a user to
extract and collect a blood sample from his finger and immediately
apply one or more required blood tests to the blood sample, while
in comfort of his private settings without the need of any clinical
assistance or a professional help. Moreover, as also indicated
above the device of the invention permits a blood testing in a
semi-automated or passive manner, i.e. permitting passive
extraction of a blood sample, while the finger is maintained in
substantially the same position with respect to the device during
the sequential occurrence of piercing and sampling procedures and
possibly also during the testing procedure, practically immediately
one after the other.
[0151] More specifically, the finger is brought in the operative
position, and while the finger's position is kept, the device
operates as follows: The device is brought into its piercing mode,
and a piercing element is applied for piercing a finger portion
(such as a finger tip); the device is shifted into a sampling mode,
by manipulating one or more elements of the sampling assembly to a
sampling position for collecting the blood sample in a blood
holding element; and upon identifying that sufficient blood has
been collected (i.e. equal to or above a minimum volumetric
threshold), and further validating that excess blood (i.e. over a
maximum threshold) is removed, the device is shifted into its
testing position, while the user is allowed to remove his finger
from its operative position.
[0152] Thus, through the entire orchestrated procedure, the finger
can remain static in a finger cavity or another finger holding
element (or generally located on a finger site), while the complex
functionalities are actuated without assistance of clinical
personnel.
[0153] It should also be noted that the integrated device of the
present invention can be configured to carry out the piercing,
sampling and testing procedures in a hands-free fashion for the
user, i.e. the user does need not to support/hold the integrated
device by hand. The user can position the integrated device on a
table, for example, jus to provide a physical support required to
maintain the device static during piercing, sampling and testing.
Therefore, the individual using the device is relieved from the
need to actively bring the piercing assembly to the proximity of
the finger or finger tip, and thus may focus on merely placing the
finger or finger tip at the appropriate cavity or support. This
reduces the fear factor which is one of the major drawbacks of
finger piercing assembly which typically require that user actively
operates to bring the piercing assembly in the suitable position in
proximity of the finger prior to piercing (which is deterring
especially for unskilled users).
[0154] The integrated device of the present invention allows for
using all the required reagents for blood testing, and due to the
ability of the device to supply precise amount of blood for the
blood test, allows blood testing in the private settings of the
user while assuring that the test is of a quality comparable to
that of the clinical settings. This is also facilitated by the
control and protected environment created within the integrated
device which allows the passive extraction as defined above. In
particular, the structure of the device permits sequential, and
immediately one after the other, execution of piercing, sampling
and testing in a controlled manner which assures repeated
piercing/sampling/testing conditions and thus increasing the
confidence in the measurement performed. The integrated device can
accurately and successively provide several operational states of
the device namely: piercing, sampling and testing, starting one
after the other in a predetermined order. It should be noted that
generally the device may be configured such that the different
procedures, while being successively started, occur in timely
separated sessions or partially timely overlapping. By way of a
non-limiting example, in a sampling state the testing cannot be
performed and visa-versa. The inventors have found that under
certain conditions simultaneous operations of sampling and testing
inherently might reduce the accuracy of the measurement resulting
from inaccuracies caused by user mistakes and variations resulting
from fear induced by a blood drawing scenario.
[0155] The device preferably comprises a moving carriage which
incorporates or is connected to at least some elements of the
piercing assembly, the sampling assembly (a blood
collecting/holding element) and the testing assembly. The carriage
is displaceable with respect to a finger site, i.e. the finger
location when in the operative position. Movement of the carriage
in a certain direction (typically in a horizontal plane) relative
to the finger site thus successively shifts the device through its
piercing position, and sampling and testing position. The
configuration may be such that a bottom plate of a liquid reservoir
of blood holding element is additionally (e.g. linearly or
pivotally) movable with respect to said carriage and said finger
site between a closed position of the liquid reservoir
(corresponding to the blood collection state) and an opened
position of the reservoir (corresponding to the blood testing
state). To this end, the device preferably utilizes a blood holding
element in the form of a reservoir enabling collection and
containing a liquid-phase blood sample. In other words, the
reservoir is a container having a hollow cavity defining the blood
volume required for the test. As will be described below, the use
of such liquid container also facilitates indication of the
sampling state to the user, i.e. whether the container has
collected the sufficient blood amount or not, as well as whether
there is no excess of blood during testing. As described above and
will be exemplified further below, according to some embodiments,
device may comprise a reagent(s) holding unit, disposed vertically
above a blood holding element, which, when in the testing position
of the device is aligned above the test strip.
[0156] As indicated above, the integrated device of the invention
assures a precise blood volume collection, by defining both minimal
volumetric quantity and maximal volumetric quantity for the
accurate testing. Again, it ensures repeated and identical
sampling/testing conditions which are the essence of providing
blood testing with increased credibility. In addition, the blood
test can also be performed on crude blood portion which can
optionally be transported within the moving internal parts of the
device without being flown through a porous media which may affect
the testing results.
[0157] Table 2 exemplifies a relation between the different
procedures (piercing, sampling and testing) with respect to the
order of occurrence of these procedures and respective structural
elements/assemblies with respect to one another, according to
preferred embodiment of the invention.
TABLE-US-00002 TABLE 2 Device functionalities/states
Element/Assembly Element conditions Piercing Sampling Testing
Movable carriage Piercing(X) Sampling/Testing(.largecircle.) X
.largecircle. .largecircle. Funnel assembly Sampling (X)
Testing(.largecircle.) X X .largecircle. Blood holding element
Sampling Testing(.largecircle.)/opened X X .largecircle.
(X)/closed
[0158] As can be seen in the above Table 2, in the present example,
the device of the present invention includes a movable carriage
associated with (carrying or connected to) the elements of the
piercing, sampling and testing assemblies; a funnel assembly
optionally provided and being pivotally movable with respect to the
carriage for selectively allowing the device operation in the
sampling or testing mode; and a blood holding element shiftable
between its closed position (sampling state) and opened position
(testing state). The funnel assembly includes elements relating to
the sampling and testing means, as will be described more
specifically further below. The movable carriage is displaceable
between its first position corresponding to the piercing mode of
the device operation, and its second position corresponding to the
sampling and testing modes of the device operation. When the
carriage is in the first position (relative to the finger site),
the device is operable in the piercing mode (denoted "x"), and when
the carriage is brought to its second position, the device can
successively perform the sampling and testing modes ("o"). While in
the second position of the carriage, the position of the funnel
assembly defines the device position corresponding to the sampling
mode or the testing mode. In the same second position of the
carriage, upon identifying that the required blood sample has been
collected, a position of the funnel assembly shifts the blood
holding element from its normally closed to its opened position
allowing the blood sample interaction with the testing means.
[0159] The following are several specific but not limiting examples
of the configuration and operation of the device of the present
invention.
[0160] Reference is made to FIGS. 5A-5J exemplifying the
configuration and operation of an integrated device 1000 of the
present invention. FIGS. 5A and 5B are cross-sectional views of the
integrated device while in its sampling/testing position and
piercing position respectively. FIGS. 5C and 5D are side
cross-sectional views of the device while in its sampling and
testing modes respectively, and FIG. 5E shows another
cross-sectional view of the device while in the sampling/testing
position. FIG. 5F and FIGS. 5H, 5G show respectively an isometric
view and top views of the device. FIG. 5I shows the device with a
user's finger positioned on the finger support element; and FIG. 5J
is an exploded view of the device. The invention will be described
below with reference to all these figures.
[0161] A medical device for a blood test is thus provided, the
device comprising: (i) a housing defining a finger site for
supporting a user's finger or a portion thereof within said finger
site during the device operation; (ii) piercing, sampling and
testing assemblies sequentially actuatable to successively initiate
piercing, sampling and testing operational modes of the device;
(iii) a carriage at least partially accommodated within said
housing and being adapted for movement with respect to said finger
site between its first position corresponding to the piercing mode
of the device and a second position corresponding to the sampling
and testing modes of the device, the device being thereby capable
of operating in the piercing, sampling and testing modes while at a
static position of the user's finger.
[0162] The integrated device 1000 includes a housing 1070 which
defines a finger site, generally at 1010, which may for example be
in the form of a cavity (sampling cavity) and serves for supporting
a user's finger or a portion thereof within said finger site during
the device operation. The device includes piercing, sampling and
testing assemblies, the configuration and operation of which will
be described further below, and provides for sequentially actuation
of these assemblies to successively initiate piercing, sampling and
testing operational modes of the device. Further provided in the
device is a carriage 1050. The carriage is at least partially
accommodated within the housing 1070 and is adapted for movement
with respect to the finger site 1010 between a first position
corresponding to the piercing mode of the device and a second
position corresponding to the sampling and testing modes of the
device.
[0163] The carriage incorporates or is connected to at least some
of the elements of the piercing, sampling and testing assemblies,
as will be described below. The carriage 1050 is movably mounted on
a (horizontal) base 1012 which provides physical support to the
device, especially needed during piercing and sampling. Preferably,
such physical support includes, in this respect, the ability to
maintain a steady and/or static location of the entire device and a
position of the device on at least partially horizontal plane. In
other words, an external bottom surface of the base 1012 is
preferably provided with means for maintaining physical contact
with a contacting surface. By way of non-limiting example, the
surface can be that of a table which is typical in the private
settings of the user. The base provides friction with the contact
surface so as to resist the movement of the device during piercing
and/or testing. Friction can be affected by application of
rubber/plastic based layer adhesively coupled to the base 1012 thus
preventing movement. Alternatively, a fabric layer or a sticker may
be used to achieve similar function. The person skilled in the art
would know to employ alternatives to affect such resistant or
friction and prevent the movement of the integrated device during
piercing, sample and testing.
[0164] Thus, in this example, the integrated device 1000 includes a
top housing 1070 defining a finger site where the finger (or
portion thereof) is to be located during the device operation. The
finger site may be constituted by the finger support element 1010
(which is at least partially horizontal when the device is put in
operation). The finger support element 1010 is, by way of
non-limiting example, in the form of a finger recess or cavity
which allows the user to position the finger (or portion thereof)
during the device operation (in an at least partially horizontal
angle).
[0165] The device 1000, at the finger site or the finger support
element 1010, is formed with an orifice 1030 for allowing access
(e.g. vertical passageway) for a piercing element 1061 (associated
with the piercing means, and including blade or needle) to a finger
under test. In this example, the orifice 1030 allows the piercing
element to pass in an upright direction therethrough and effect the
piecing procedure on the finger. The orifice 1030 enables the
piercing element 1061 to reach and protrude the skin layer of the
finger. The orifice is optionally positioned so as to ergonomically
force or direct the user to position the finger exposing the
optimal location for blood extraction at the middle of the top pad
of the finger.
[0166] In addition, the orifice 1030 may be positioned at a certain
predetermined distance from a location/site of the housing
designed/intended for a finger holding assembly to enable
application of pressure to the finger part. It should be noted that
the housing is preferably formed with a projection/stopper 1020
defining the location of the finger tip surface when the finger is
brought to the finger site. The piercing orifice is preferably made
at a predetermined location (e.g. 10 mm) from said stopper.
Optimizing the location of the piercing orifice (i.e. defining the
piercing spot) with respect to the finger tip surface and the
pressurized location on the finger, and preferably also optimizing
the pressurizing location with respect to the finger tip, improves
the device performance and the test results. As will be described
more specifically further below, the finger holding assembly
includes a pressure element, e.g. configured to apply pressure to a
circumferential portion of the finger. As shown, in some
embodiments, the location/site of the housing intended for the
pressure element is formed as a depression/groove 1035 in the top
housing.
[0167] The inventors have found that blood testing of clinical
quality is dependent on the ability of a tester to extract a
predetermined blood volume during the sampling (as described
above), and also on the ability of the testing device to extract
equal blood quantities in a repeated manner. This task can be
facilitated by configuring the device so as to ergonomically force
or direct the user to mutually position the finger and the finger
holding assembly in an optimal mutual position which optimizes the
blood flow upon piercing. The optimal location of the pressure
element (of the finger holding assembly) on the finger is proximate
to the distal interphalangeal joint of the pointing (or middle)
finger or at about 6-13 mm measured from the middle of the top pad
of the finger.
[0168] In some embodiments, the depression 1035 is located at a
certain predetermined distance 1005 from the distal end 1020 of the
finger support 1010, where this distance is selected so as to
enable optimized application of pressure onto the finger when the
pressure element of the finger holding assembly is located in the
depression 1035. The optimal value (d) for the distance 1005
between the distal end 1020 and the depression 1035 is about
10.ltoreq.d.ltoreq.20 mm. On the one hand, this distance is
selected to optimize and assure that a ring-like configuration of
the finger holding assembly 2000 (or other clasping means) applies
circumferential pressure at the optimal location on the tested
finger. Additionally, it assures that the ring-like assembly 2000
or other clasping means provides circumferential pressure at the
optimal distance from the piercing location defined by the position
of the orifice 1030.
[0169] It should be understood that circumferential pressure or
circumferential pressure element refers to a ring-like stretchable
element capable of at least temporarily wrapping/hosting at least a
circumferential portion of the finger of the user (preferably all
the circumference) such that upon application of force (such as
pulling or stretching a stretchable member) the application of
tight pressure is effected upon the lateral circumference of the
finger.
[0170] As indicated above, the integrated device 1000 comprises the
movable carriage or assembly 1050. A motion path of the carriage
with respect to the finger site defines at least two successive
(horizontal) positions of the carriage corresponding to different
operational modes of the device. These horizontal positions include
a first, piercing position corresponding to a piercing mode of the
device, and a second, sampling/testing position corresponding to a
sampling/testing mode of the device. Thus, in some embodiments,
movable carriage 1050 is mounted for reciprocating movement between
the sampling/testing position (selection between sampling and
testing can be provided by another structural features discussed
below) and the piercing position.
[0171] It should be noted that the movement of the carriage 1050
can be permitted in the inner volume of the integrated device i.e.
hidden from the sight of the user. This further reduces the fear of
pain typically suffered by such users.
[0172] Movement of the carriage can be implemented using a
spring-like mechanism, constituted in this example by a spring
ejector 1080, which is for example accommodated within a receiving
cylinder 1081. The spring ejector 1080 is shiftable between its
contracted and extracted states. Where the spring based ejector is
contracted (as shown in FIG. 5A), the movable carriage 1050 can be
positioned in the piercing position. The spring ejector 1080 being
in the extracted/extended form can maintain the movable carriage in
the sampling/testing position. Alternatively, the spring based
ejector 1080 is extended in the piercing position, while being
contracted to maintain the movable carriage in the sampling/testing
position.
[0173] The use of a spring-like mechanism 1080 permits and operates
the movable carriage 1050 to swiftly and/or immediately switch
between the piercing and sampling/testing positions. The movable
carriage 1050 facilitates or provides a carriage feed mechanism
which will be elaborated herein below,
[0174] In the piercing position, a piercing element (such as a
lancet) 1061 is horizontally aligned beneath the orifice 1030
(finger site). The piercing element 1061 is accommodated in a
receiving element 1060, which is releasable attachable in a housing
1065 of the sp ring mechanism. Upon actuation (e.g. by user
pressing a button), the spring like element 1062 accelerates the
piercing element 1061 to protrude the orifice 1030 towards the
finger placed in proximity to the orifice 1030 and thus pierce the
skin of the finger.
[0175] In some embodiments, the movable carriage 1050 being in the
piercing position exposes the otherwise hidden piercing element
1061. On the other hand, in the sampling/testing position, the
piercing element 1061 is in the contracted position and is thus
hidden from the orifice line of sight.
[0176] In some embodiments, the piercing position facilitates
horizontal alignment of the orifice 1030 with the piercing element
1061 while preventing alignment of the orifice with a blood holding
element 1045.
[0177] In some embodiments, the sampling/testing position prevents
alignment of the orifice with the piercing element 1061 while
providing alignment of the orifice with the blood holding element
1045 (being an element of the blood sampling assembly).
[0178] The blood holding element 1045 is mounted on and carried by
the carriage to be movable with respect to the finger site, i.e. to
be brought to and away from the finger site. Optionally, a funnel
assembly is provided, being for example mounted for (pivotal)
movement with respect to the carriage (with respect to the blood
holding element) and with respect to the finger site. The
configuration and operation of the funnel assembly will be
described further below. The blood holding element 1045 defines a
blood collecting cavity (hollow liquid reservoir) enabling
collection of blood in the liquid phase rather than absorbing
blood. The blood holding element is typically shaped like a cup or
has some other cylindrically-like shape (e.g. hollow liquid
reservoir) for collecting blood extracted from the finger by
piercing. The element 1045 has a top opening 1048, side surfaces
1046 and a bottom plate 1150. The bottom plate 1150 is shiftable
between its closed position, in which it is aligned with the side
surface thus closing the reservoir at the bottom thereof, and an
opened position in which it is misaligned with the side walls thus
forming a bottom opening 1047 of the reservoir. The latter should
be large enough to allow viscous fluid such as blood to pass
therethrough by gravitation, optionally without active assistance
e.g. suction.
[0179] Thus, the blood holding element 1045 is configured to be
shiftable between at least two configurations: a closed
configuration (when the bottom plate is aligned with the side
walls), and an opened configuration (when the bottom plate moves
away from the alignment position). In the closed configuration, the
blood holding element 1045 accumulates fluid or blood therein. FIG.
5C illustrates the closed configuration, while FIG. 5D corresponds
to the opened configuration. In the opened configuration, the blood
holding element permits emptying or fluid evacuation. Preferably,
emptying or fluid evacuation is actuated by gravitation. In the
closed configuration, the bottom plate (stopper) 1150 contacts/is
aligned with the side walls 1046 so as to prevent fluid passage
through the bottom opening 1047 of the blood holding element 1045.
To achieve fluid tight contact, the bottom stopper 1150 can be
manufactured with a layer of elastomeric/rubber-like materials as a
sealant. In the open opened configuration, fluid impermeable bottom
stopper 1150 is relocated to allow or permit fluid passage from the
blood holding element 1045 downwards through the bottom opening
1047.
[0180] Switching the blood holding element 1045 between the two
configurations (opened and closed configurations) can for example
be performed by directly manipulating the fluid impermeable bottom
stopper 1150 to relocate and substantially evacuate the bottom
opening. Alternatively, the blood holding element 1045 can switch
between the two configurations by an external assistance or an
externally applied force, such as by insertion of a test strip 1512
which applies mechanical force onto the bottom element 1150 in a
horizontal direction to move it away from the reservoir, which is
demonstrated in FIG. 5D. In some embodiments, the bottom stopper
1150 radially moves about an axis 1196 to swing between the opened
configuration and the closed configuration.
[0181] The test strip 1512 forms the testing assembly. The test
strip is selectively insertable into a position in which a portion
thereof is aligned with a reservoir (e.g. and also with a piercing
orifice) to receive a blood sample from the reservoir (blood
derived from the finger after piercing). The configuration may be
such that the test strip is insertable into a slot made in the
housing in a manner enabling sliding movement of the test strip
towards and away from a location of alignment with the reservoir.
In particular, FIG. 5D illustrates the test strip 1512 being
inserted into a slot made in the housing of the device, e.g. in the
carriage. When the test strip is in such inserted position it
pushes the bottom stopper of the sampling assembly (of the
reservoir) to move away from the finger site, and the test strip
becomes vertically aligned with the test site. As a result, the
fluid/blood is allowed to escape from the reservoir through the
bottom opening 1047 by gravitation to thereby immediately interact
with the test strip.
[0182] As indicated above, the device optionally includes a funnel
assembly 1042. The funnel assembly 1042 is formed by a fluid/blood
funnel part 1040 and optionally a reagent funnel part 1041. As
demonstrated in the exploded isometric FIG. 5J, the funnel assembly
1042 is typically configured to define an axis 1152 which can be
fitted/aligned in/with a vertical, cylindrically or tubular shaped,
hollow groove having an opening 1197 for receiving axis 1152. The
hollow groove permits displacement of the funnel element 1042
specifically from the blood sampling position and the testing
position as detailed below. In the blood sampling position of the
funnel assembly 1042, blood flowing from the pierced location of
the finger is collected (i.e. sampled), while in the testing
position of the funnel assembly, the testing procedure takes
place.
[0183] In some embodiments, the blood funnel 1040 and the reagent
funnel 1041 are mutually displaced between different relative
positions relative to the finger site such that in each position
only one of the funnels can be aligned with the blood holding
element 1045 (liquid reservoir). The mutual displacement may be
actuated by manipulation of the funnel assembly 1042.
[0184] The blood funnel 1040 or funnel assembly 1042 can thus be
actuated to be shiftable between at least two positions: blood
sampling position; and testing position. In some embodiments, the
funnel assembly 1042 and the fluid impermeable bottom stopper 1150
are coupled together, optionally by mutual fixed engagement by axis
1152 or an axial coupling. If such configuration is utilized, the
blood sampling position is simultaneously actuated together with
the closed position of the blood holding element 1045. The testing
position is simultaneously actuated together with the opened
position of the blood holding element 1045.
[0185] In the blood sampling position, fluid funnel 1040 is aligned
with the blood holding element 1045 and optionally further aligned
with the orifice 1030. This alignment facilitates blood
flow/drop/fall through the orifice 1030 into the blood holding
element 1045 (e.g. hollow cup or reservoir), through the fluid
funnel 1040. In the testing position, the reagent funnel 1041 is
moved to be aligned with both the blood holding element and the
test strip portion 1511.
[0186] It should be noted that typically prior to the alignment of
the reagent funnel 1041 with the test strip portion 1511 the blood
occupying the blood holding element 1045 has already been flowing
from the reservoir and contacting the test strip at portion 1511.
The switch to the testing position can provide clean reagent funnel
1041.
[0187] As indicated above, in some embodiments, the fluid funnel
1040 radially rotates about an axis 1196 to swing or switch between
the blood sampling position and the testing position.
[0188] Generally, the provision of the fluid funnel is aimed at
facilitating removal of excess blood from the reservoir (amount of
blood above the predetermined volume defined by the volume of the
reservoir, as well as facilitating indication of the full-reservoir
state. The use of the fluid funnel actually corresponds to a
two-part design of the liquid reservoir, as will be described
below.
[0189] In some embodiments, the fluid funnel 1040 at its upper
(top) portion 1520 is formed with a projecting slope 1525. During
the blood sampling procedure, the fluid funnel 1040 is aligned with
the blood holding element 1045, such that the fluid funnel forms an
upper extension (top portion) of the reservoir 1045. When the
reservoir 1045 together with its upper part 1040 becomes filled
with the blood sample, i.e. the blood reaches the funnel end 1520,
excess blood is cleared or removed from the blood holding element
1045 via the slope 1525 towards an indication window 1527. Excess
blood removal is optionally provided by gravity. Where blood
accumulates over the upper limit of the funnel end 1520 is slides
downwards along the slope 1525. To facilitate prompt clearance of
blood through the slope, it may comprise a porous medium driving
the excess blood to the proximity of the indication window 1527.
The porous medium may be in the form of a capillary sponge layer
over the slope 1525. A capillary tube or any other element may be
used which "pulls" the blood into the indication spot.
[0190] In one embodiment, where blood accumulates over the upper
limit of the funnel end 1520 prompt clearance of blood is provides
by a porous medium driving the excess blood to the proximity of the
indication window 1527 with or without the aid of a slope.
[0191] It should be understood that provision of the projecting
sloped member for flowing the removed blood towards the indication
window is optional, and if used is not limited to the two-part
design of the blood holding element (reservoir with removable
funnel). Indeed, such a projecting sloped member may be formed at
the top edge of the single-part reservoir. Thus, generally, if the
provision of the projecting sloped member is considered, it may be
associated with the removable top part of the two-part blood
holding element or with the top portion of the single-part blood
holding element (reservoir),
[0192] The following is an example of the operational steps of the
device 1000 of the present invention.
[0193] The device 1000 is placed on a horizontal plane such as a
table. A user places his finger onto the finger support element
1010 to be at the finger site. Preferably, the finger is hold by
the finger holding assembly, e.g. is inserted to a ring-like finger
holding element 2000 (which will be described more specifically
further below), which is fixedly located at the depression 1035.
The finger holding element is tightened to ensure accumulation of
blood in fleshy pouch of the finger or the middle of top pad in the
finger extremity.
[0194] The device 1000 can be pre-set to a piercing position.
Considering an optional use of the funnel element 1042, it may be
brought to the blood sampling position at this initial piercing
position of the device. Upon actuation of the piercing mode, the
piercing assembly operates to release the piercing element (lancet)
1061 to move upwards to the finger at the finger site. The middle
of top pad in the finger extremity is pierced by the lancet.
[0195] The movable carriage/device is then actuated (by the user or
automatically) to shift to the sampling/testing position. Blood
flows or falls by gravity (e.g. through the fluid funnel 1040) and
accumulates within the blood holding element (liquid reservoir)
1045. At this stage, the blood holding element is in the closed
position thereof which is required to collect fluid therein.
[0196] Blood is being collected (i.e. sampling mode proceeds) until
the blood level reaches its maximum (e.g. reaches the funnel end
1525) and subsequently appears in the indication window 1527.
Appearance of blood in the indication window 1527 indicates to the
user that sufficient blood has been collected, corresponding to the
end of the sampling mode. The user may thus release his finger by
opening the apparatus 2000 or other clasp.
[0197] It should also be noted that the invention advantageously
(from the physiological and environment point of views) provides
for that the extracted blood is almost invisible during the whole
procedure, while being present inside a closed system. This results
in less cross blood contamination and much more hygienic procedures
during the blood test.
[0198] The blood holding element 1045 can be actuated
(automatically or by user manipulation) to be shifted into the
opened position thereof, thereby actuating the testing mode. User
can actuate the testing mode by inserting the test strip 1512 to a
testing opening 1570, or by pushing the previously inserted test
strip, to engage the bottom opening 1047 about the contact point
1151 and replace it by a portion of the test strip. Optionally, the
funnel element 1042 is concurrently actuated to move to the testing
position. The clean reagent funnel 1041 is thus placed vertically
above the blood holding element 1045 (replacing the fluid funnel)
so as to permit reagent passage therethrough. The opened position
of the blood holding element 1045 permits deposit or evacuation of
the collected blood sample (the desired amount thereof
corresponding to the volume of the reservoir) onto the test strip.
The fluid funnel structure having the funnel end 1520 limits the
transfer of blood to the test strip to a predetermined maximal
volumetric quantity. By way of non-limiting example, the
predetermined maximal volumetric quantity is 2 drops or 25-75
microL. Certain maximal volumetric quantity can also be maintained
by the fact the funnel element 1042 may shift horizontally if
manipulated and thus physically remove the excess of blood that has
been accumulated in the blood funnel volume 1040. There may be a
reagent measuring element (not shown), which limits the transfer of
the reagent to the test strip to be of a maximal volumetric
quantity.
[0199] Thereafter, a test result appears in an appropriate results
window on the test strip.
[0200] Reference is now made to FIGS. 6A-6H providing a schematic
illustration of the finger holding assembly 2000. The latter is
configured to apply pressure to a circumferential part of the
finger, by using a circumferential pressure element. FIGS. 6A-6D
demonstrate the ring-like assembly 2000 in an open position
thereof, and FIGS. 6E-6H demonstrate the ring-like assembly 2000 in
its closed position for wrapping the finger portion. FIGS. 6I and
6J show the ring-like assembly 2000 while fitting the finger.
[0201] The finger holding assembly 2000 is used to actuate or
facilitate circumferential pressure around a portion of the finger
from which blood is drawn. In particular, the pressure is actuated
on a specific finger portion which optimizes the blood withdrawal
and substantially reduces pain involved in the finger piercing. The
specific finger portion is at about the distal interphalangeal
joint of the pointing finger (or middle finger) at about 6-13 mm
measured from the middle of the top pad of the finger.
[0202] The finger holding assembly 2000 is therefore configured and
operable to ergonomically force or direct the user to position the
pressure to the specific finger portion which optimizes the blood
withdrawal and substantially reduces pain involved in the finger
piercing.
[0203] The finger holding assembly 2000 includes a stretchable
elastomeric elongated strip 2010 having a distal end 2011 and a
proximal end 2012, and a loop member 2040 coupled to the elongated
strip 2010 at the proximal end thereof. The loop member 2040 is
typically manufactured from elastomeric material(s) such as rubber
or rubber-like material, such as for example, silicone rubber.
[0204] The finger holding assembly 2000 thus includes a finger
holding element 2010 configured to be fit on the finger such as to
apply certain pressure to the finger. The finger holding element is
a band or strip operable to be shifted from its open inoperative
position to a closed-loop operative position in which it fits the
finger. The band when in the operative position thereof applies the
pressure to the finger while preventing over-pressing of the
finger, thereby reducing pain associated with the blood test.
[0205] The elongated strip 2010 is carried by or is provided with
teeth or other projecting members 2015. The projecting members 2015
are configured to engage a locking tooth/member 2035 which is
typically located in the interiors of the loop member 2045. The
interior of the loop member 2045 is shown in a cross-sectional
isometric view in FIG. 6C.
[0206] In some embodiments, the projecting members 2015 and the
locking member 2035 are configured with appropriate geometry (shape
and size) so as to be appropriately engaged. This engagement is
such as to effect application of a circumferential pressure
suitable for producing optimal blood flow through the pierced
portion of the finger while restricting venous flow.
[0207] The inventors have found that the pressure range which
optimizes the blood flow to the pierced portion of the finger also
substantially reduces pain associated with the finger tip piercing.
In particular, the inventors designed the projecting members 2015
and the locking member 2035 from silicone rubber (or other elastic
material) in size(s) and dimension(s) to apply circumferential
pressure of about 30-75 mBar. As explained further below, the
material selection and design of the projecting members 2015 and
the locking member 2035 permits retraction of the assembly at least
in part in response to actuation of excessive force by the
user.
[0208] This is based on the inventors' understanding that one the
shortcomings of the conventional techniques of the kind specified
is associated with that, according to this approach, a user has to
releasably adjust a pressure element without knowing about the
optimal pressure to be applied. Therefore, users (normally
fear-full users) apply excessive force on the finger which results
in increased pain and also hinders the ability to perform the test
adequately. Excessive pressure can also result in blood quantities
which fall short of the minimum required for the blood testing.
[0209] Therefore, the finger holding assembly 2000 is configured
and operable such that upon application of excessive pressure (or
over-pressing) on the circumference of the finger, pressure is
automatically relieved to the optimal pressure range. The
projecting members 2015 and the locking member 2035 are configured
to succumb or yield under the excessive force. In such a case,
where excessive force is actuated by the user, the finger holding
assembly 2000 is being retracted at least in part. The retraction
continues until the circumferential pressure is reduced to the
pressure level tolerated by the locking members 2015 being engaged
with the projecting member 2035. Additional advantage in this
respect is that pressure adjustment is provided without the
subjective (sometimes erroneous) pressure perception of the
user.
[0210] The finger holding assembly 2000 can also include a cap-like
member 2020. The cap-like member 2020 is of a size and proportion
to accommodate the finger of the user during piercing and sampling.
The cap-like element 2020 is configured to accommodate at least a
portion of the finger and has a distal end comprising a contact
surface and a proximal end connected to a portion of the band 2010.
The cap-like member is typically provided with a slit 2025 suitably
positioned to permit the finger nail to protrude therethrough, and
thus the finger conveniently abut the distal end of the cap
2050.
[0211] Where the user fits his finger into the cap 2020, optionally
permitting his finger nail to protrude from through the slit 2025,
he can circumferentially wrap the elongated strip 2010 around the
finger. The distal end 2011 of the strip 2010 is inserted into the
loop 2040 as schematically shown in FIG. 6E. The projecting member
2015 and the locking member 2035 are engaged and lock the elongated
strip 2010 so as to produce the optimal or suitable circumferential
pressure on a portion of the finger. If the user applies excess
pressure, the projecting member 2015 and the locking member 2035
succumb or yield under the excessive force and thus being retracted
at least in part to releasably produce the appropriate pressure
range.
[0212] In addition, the cap-like member 2020 is preferably
configured to optimize a distance between a pressure point
(pressured location) 2031 and the distal end 2030 to a
predetermined optimal value (d2) or range of values, for example
10.ltoreq.d2.ltoreq.20 mm. Maintaining the optimal distance secures
that pressure is actuated on a specific finger portion which
optimizes the blood withdrawal and reduces pain involved in the
finger piercing. The specific finger portion is at about the distal
interphalangeal joint of the pointing (or middle) finger or at
about 6-13 mm measured from the middle of the top pad of the
pierced finger.
[0213] The finger holding assembly 2000 of the present invention
can be used in conjunction or in combination with the
above-described integrated device 1000 or any other device of the
kind specified. Also, the use of the cap-like member 2020 in the
ring-like finger holding assembly 2000 is optional. Typically, the
finger holding assembly 2000 can be fitted or integrated in the
depression 1035 which is suitably sized to accommodate its use.
* * * * *