U.S. patent application number 13/776488 was filed with the patent office on 2013-10-17 for fully integrated wearable or handheld monitor.
The applicant listed for this patent is Intuity Medical, Inc.. Invention is credited to Jeffrey L. Emery, Raul ESCUTIA, Craig M. Litherland, Christo P. Pamichev, James W. Pfeiffer.
Application Number | 20130274568 13/776488 |
Document ID | / |
Family ID | 37906718 |
Filed Date | 2013-10-17 |
United States Patent
Application |
20130274568 |
Kind Code |
A1 |
ESCUTIA; Raul ; et
al. |
October 17, 2013 |
FULLY INTEGRATED WEARABLE OR HANDHELD MONITOR
Abstract
An arrangement comprises a housing containing one or more
components configured for at least one of body fluid sampling and
analysis. The arrangement includes a housing containing one or more
components configured for at least one of body fluid sampling and
analysis, and a body attachment element. The housing and the body
attachment element are connected by a quick-release mechanism
configured to facilitate removal of the housing from the body
attachment element.
Inventors: |
ESCUTIA; Raul; (Sunnyvale,
CA) ; Litherland; Craig M.; (Cupertino, CA) ;
Emery; Jeffrey L.; (Redwood City, CA) ; Pfeiffer;
James W.; (Los Gatos, CA) ; Pamichev; Christo P.;
(Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Intuity Medical, Inc. |
Sunnyvale |
CA |
US |
|
|
Family ID: |
37906718 |
Appl. No.: |
13/776488 |
Filed: |
February 25, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11529612 |
Sep 29, 2006 |
8382681 |
|
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13776488 |
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60721966 |
Sep 30, 2005 |
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Current U.S.
Class: |
600/309 |
Current CPC
Class: |
A61B 5/150969 20130101;
A61B 5/150412 20130101; G01N 21/0303 20130101; A61B 5/150984
20130101; A61B 2560/0443 20130101; A61B 5/1411 20130101; A61B
5/15161 20130101; A61B 5/151 20130101; A61B 5/1468 20130101; A61B
5/150167 20130101; A61B 5/150396 20130101; A61B 5/14546 20130101;
A61B 2560/0462 20130101; A61B 5/15163 20130101; A61B 5/15151
20130101; A61B 5/6828 20130101; A61B 5/150229 20130101; A61B
5/150946 20130101; A61B 5/15111 20130101; A61B 5/15121 20130101;
A61B 5/150022 20130101; A61B 5/150954 20130101; A61B 5/155
20130101; A61B 5/157 20130101; A61B 5/150068 20130101; A61B 5/681
20130101; A61B 5/14532 20130101; A61B 5/150099 20130101; A61B
5/15113 20130101; A61B 5/15117 20130101; A61B 5/150076 20130101;
G01N 21/77 20130101; A61B 5/150083 20130101; G01N 1/14 20130101;
A61B 5/1427 20130101; A61B 5/1486 20130101; A61B 5/15146 20130101;
A61B 5/15148 20130101; A61B 5/6824 20130101; G01N 27/416 20130101;
A61B 5/15123 20130101; A61B 5/150389 20130101; A61B 5/15186
20130101; A61B 5/150343 20130101 |
Class at
Publication: |
600/309 |
International
Class: |
A61B 5/157 20060101
A61B005/157; A61B 5/1468 20060101 A61B005/1468; A61B 5/151 20060101
A61B005/151; A61B 5/00 20060101 A61B005/00; A61B 5/15 20060101
A61B005/15 |
Claims
1. An integrated body fluid sampling and analysis device, the
device comprising: a housing, the housing containing a plurality of
body fluid sampling and analysis sites, each of the sites
comprising a skin-penetration member; a body attachment element;
and a quick release mechanism connecting the housing and the body
attachment element.
2. The arrangement of claim 1, wherein the body attachment element
comprises a band configured to be secured to the wrist of a
wearer.
3. The arrangement of claim 1, further comprising a disposable
portion and a reusable portion.
4. The arrangement of claim 1, wherein each of the sampling and
analysis sites further comprises an actuator configured to drive
the skin-penetration member into the skin of a user.
5. The arrangement of claim 4, wherein the actuator is configured
to accelerate the skin-penetration member along a curved or
rotational path.
6. The arrangement of claim 5, wherein the actuator comprises a
torsional spring.
7. The arrangement of claim 4, wherein each of the sampling and
analysis sites further comprise a trigger configured to release the
actuator.
8. The arrangement of claim 1, wherein the skin-penetration member
comprises a hollow needle.
9. The arrangement of claim 1, wherein the analyte quantification
member comprises an assay pad, the assay pad comprising a chemical
reagent for producing a detectable signal upon reaction with a
target analyte.
10. The arrangement of claim 9, wherein the signal is optically
detectable, and the arrangement further comprises a detector
configured to detect the signal.
11. The arrangement of claim 1, wherein the analysis sites are
arranged about a circle in a circumferential manner.
12. The arrangement of claim 11, wherein the analysis sites are
oriented in the radial direction.
13. The arrangement of claim 1, wherein the sampling and analysis
sites are oriented in a linear manner.
14. The arrangement of claim 4, wherein the actuator comprises a
coil spring, the arrangement further comprising a relatively
rotatable camming or ramping surface configured to interact with
the coil spring such that energy stored therein is released at a
predetermined release point.
15. The arrangement of claim 4, wherein the actuator comprises a
cantilevered spring arm, the arrangement further comprising a
release member and a rotatable surface formed with a break therein,
the arrangement configured such that as the release member comes
into registry with the break, the energy stored in the spring arm
is released.
16. The arrangement of claim 1, wherein the skin-piercing member is
attached to a first mounting arm, the arrangement further
comprising at least one second mounting arm located above the first
mounting arm, and a weight attached to the end of the second
mounting arm, whereby the weight can be driven into the
skin-piercing member attached to the first mounting arm.
17. The arrangement of claim 4, wherein the actuator comprises a
cantilever beam and a rotatable cam comprising a ramp surface
comprising a break therein and configured to interact with the
cantilever beam to release energy stored therein upon coming into
registry with the break.
18. The arrangement of claim 1, wherein the skin-penetration member
comprises a bevel turned 90.degree. away from the surface of the
skin of a user.
19. The arrangement of claim 1, wherein the skin-penetration member
comprises a bevel facing toward the surface of the skin of a
user.
20. The arrangement of claim 1, wherein the skin penetration member
comprising a bevel facing away from the surface of the skin of a
user.
21. The arrangement of claim 1, wherein the housing further
comprises a display and one or more buttons.
22. The arrangement of claim 1, wherein the housing further
comprises a footprint, the footprint comprising one or more
openings in registry with one or more sampling and analysis
sites.
23. The arrangement of claim 1, wherein the quick-release mechanism
comprises a generally C-shaped portion, and a generally
cylindrically-shaped portion received within the generally C-shaped
portion with a snap-fit type connection.
24. The arrangement of claim 1, wherein the quick-release mechanism
comprises a generally hollow portion disposed on the body
attachment element received within a complementary generally hollow
portion disposed on the housing, and a clip inserted into the
generally hollow portion disposed on the housing, the clip
comprising a locking feature disposed at an end of the clip.
25. The arrangement of claim 24, wherein the locking feature
comprises a collapsible detent.
26. The arrangement of claim 1, wherein the quick-release mechanism
comprises a generally hollow portion disposed on the body
attachment element received within a complimentary generally hollow
portion disposed on the housing, the generally hollow portion
disposed on the body attachment element comprising a threaded end
and a pin received therein, the pin comprises a threaded end mating
with the threaded end of the end of the hollow portion.
27. The arrangement of claim 1, wherein the quick-release mechanism
comprises a pocket formed in the body attachment element receiving
the housing therein in a releasable manner in the form of one or
more of: a friction fit, snaps, detents or releasable
fasteners.
28. The arrangement of claim 1, further comprising a case
configured to receive the housing therein.
29. The arrangement of claim 28, wherein the case comprises a
display.
30. The arrangement of claim 22, further comprising a moveable
shield configured to close off the one or more openings.
31. The arrangement of claim 3, wherein the disposable portion
comprises a disposable cartridge.
32. An arrangement comprising: a housing containing one or more
components configured for at least one of body fluid sampling or
analysis; and a body attachment element; wherein the housing and
the body attachment element are connected by a quick-release
mechanism configured to facilitate removal of the housing from the
body attachment element.
33. A method of performing at least one of body fluid sampling or
analysis, the method comprising: providing a housing with one or
more components configured for at least one of body fluid sampling
or analysis, the components comprising at least one skin-piercing
member; providing a body attachment element; connecting the housing
to the body attachment element in a releasable manner; removing the
housing from the body attachment element; applying the housing to a
surface of the skin; and piercing the skin with the at least one
skin-penetration members.
34. The method of claim 33, wherein the step of applying the
housing to the surface of the skin comprises applying the housing
to a tip region of a finger of the user.
Description
FIELD
[0001] The present invention relates to devices, arrangements and
methods involving body fluid sampling and/or analysis. In certain
embodiments, the present invention is directed to integrated
monitoring and body fluid sampling devices and methods that are
wearable, handheld, or easily converted for use in either
manner.
BACKGROUND
[0002] In the discussion that follows, reference is made to certain
structures and/or methods. However, the following references should
not be construed as an admission that these structures and/or
methods constitute prior art. Applicants expressly reserve the
right to demonstrate that such structures and/or methods do not
qualify as prior art.
[0003] According to the American Diabetes Association, diabetes is
the fifth-deadliest disease in the United States and kills more
than 213,000 people a year, the total economic cost of diabetes in
2002 was estimated at over $132 billion dollars. One out of every
10 health care dollars is spent on diabetes and its complications.
The risk of developing type I juvenile diabetes is higher than
virtually all other chronic childhood diseases. Since 1987 the
death rate due to diabetes has increased by 45 percent, while the
death rates due to heart disease, stroke, and cancer have
declined.
[0004] A critical component in managing diabetes is frequent blood
glucose monitoring. Currently, a number of systems exist for
self-monitoring by the patient. Most fluid analysis systems, such
as systems for analyzing a sample of blood for glucose content,
comprise multiple separate components such as separate lancing,
transport, and quantification portions. These systems are bulky,
and often complicated and confusing for the user. These systems
require significant user intervention. Current systems are not
discreet, which, under certain social circumstances, may result in
diabetics not monitoring their glucose levels.
[0005] Attempts have been made in the past to take steps toward
automation of the testing process. Specifically, the Sof-Tact.RTM.
System offered by Medisense in the early 2000s had the capability
to test automatically at alternate sites without any user
intervention, but only after each lancet and test strip had been
manually loaded into the device. The device is configured for
handheld operation only and is rather large. This meter is no
longer available on the market.
[0006] A device similar to the Soft-Tact.RTM. device is disclosed
in U.S. Patent Application Publication No. 2004/0138588 A1. This
device attempts to integrate all the functions required to complete
a glucose test into one device. This device however still requires
the user to load a lancet and a test strip prior to each individual
testing event. This device is also configured for handheld
operation only.
[0007] This device is described in U.S. Patent Application
Publication No. 2005/0010134 A1, and U.S. Pat. No. 6,793,633 B2
uses a spring, or motor driven mechanism to apply pressure around
the target wound area. However, the device therein is not a fully
integrated system. From the description it appears that the user
must insert a new lancet and test strip assembly for each test.
Another disadvantage of the device is configured only for handheld
operation.
[0008] In summary, most current systems that are not integrated and
thus involve many pieces that are not convenient and make the test
difficult to perform discreetly. Other current devices that may be
somewhat integrated but still require significant user
intervention, are not discreet, and require more than one device to
complete the test.
SUMMARY
[0009] According to the present invention, there are provided body
fluid sampling and monitoring devices and methods that may address
one or more of the shortcomings noted above associated with
conventional systems and devices. According to the present
invention, there may also be provided improved monitoring and body
fluid sampling devices and methods that permit handheld operation,
wearable operation, and/or convertible for use in either
manner.
[0010] One optional advantage of the invention over current devices
is that it can be fully integrated and automated. The device can be
packaged and designed such that it may be hand held or wearable,
perhaps in the form of a wristwatch, and requires minimal or no
intervention from the wearer in order to carry out testing, thus
enhancing discreet testing. The invention also optionally enables
an array of tests to be performed through use of a disposable
cartridge or unit. For example, this system allows the user to load
one cartridge that contains everything necessary for multiple
tests. Another possible advantage of the invention is that it
requires less body fluid for an accurate test than other systems
currently available. This also facilitates reduction of pain
experienced by the user during testing. The integrated nature of a
device of the invention may also facilitate accurate tracking of
blood glucose levels over time. Current systems rely on the user to
test at specific intervals; a device constructed according to the
principles of the present invention can be capable of testing
independent of user input. A device of the present invention may
optionally be constructed to give the user the option of
automated/scheduled testing and/or on-demand testing.
[0011] It is to be understood that reference herein to first,
second, third and fourth components (etc.) does not limit the
present invention to embodiments where each of these components is
physically separable from one another. For example, a single
physical element of the invention may perform the features of more
than one of the claimed first, second, third or fourth components.
Conversely, a plurality of separate physical elements working
together may perform the claimed features of one of the claimed
first, second, third or fourth components. Similarly, reference to
first, second (etc.) method steps does not limit the invention to
only separate steps. According to the invention, a single method
step may satisfy multiple steps described herein. Conversely, a
plurality of method steps could, in combination, constitute a
single method step recited herein.
[0012] According to another optional aspect of the present
invention, there is provided an integrated body fluid sampling and
analysis device, the device comprising a housing, the housing
containing a plurality of body fluid sampling and analysis sites,
each of the sites comprising a skin-penetration member, a body
attachment element, and a quick release mechanism connecting the
housing and the body attachment element.
[0013] According to a further optional aspect, the present
invention provides an arrangement comprising a housing containing
one or more components configured for at least one of body fluid
sampling or analysis, and a body attachment element, wherein the
housing and the body attachment element are connected by a
quick-release mechanism configured to facilitate removal of the
housing from the body attachment element.
[0014] According to yet another optional aspect, the present
invention provides a method of performing at least one of body
fluid sampling or analysis, the method comprising providing a
housing with one or more components configured for at least one of
body fluid sampling or analysis, the components comprising at least
one skin-piercing member, providing a body attachment element,
connecting the housing to the body attachment element in a
releasable manner, removing the housing from the body attachment
element, applying the housing to a surface of the skin, and
piercing the skin with the at least one skin-penetration
members.
[0015] As used herein "digital" means fingers or toes. "Digital
body fluid" means expression of body fluid a wound created on the
fingers or toes, and encompasses lancing sites on the dorsal or
palm side of the distal finger tips.
[0016] As used herein "alternate-site" means a location on the body
other than the digits, for example, the palm, forearm or thigh.
"Alternate-site body fluid sampling" means expression of body fluid
from the lancing site on a surface of the body other than the
fingers or toes, and encompasses lancing sites on the palm,
forearm, and thigh.
[0017] As used herein, "body fluid" encompasses whole blood,
intestinal fluid, and mixtures thereof.
[0018] As used herein "integrated device" or "integrated meter"
means a device or meter that includes all components necessary to
perform sampling of body fluid, transport of body fluid,
quantification of an analyte, and display of the amount of analyte
contained in the sample of body fluid.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0019] The following description of preferred embodiments can be
read in connection with the accompanying drawings in which like
numerals designate like elements and in which:
[0020] FIG. 1A is a perspective view of an integrated device
constructed according to the present invention.
[0021] FIG. 1B is a sectional view taken along line 1B-1B of FIG.
1A.
[0022] FIG. 1C is a schematic illustration of an arrangement formed
according to one aspect of the present invention.
[0023] FIG. 2 is a perspective view of an arrangement constructed
according to an alternative embodiment of the invention.
[0024] FIG. 3 is a perspective view showing an arrangement
according to a further embodiment.
[0025] FIG. 4 is a cut-away view of a further alternative
arrangement of the present invention.
[0026] FIG. 5 is a perspective view of yet another alternative
arrangement of the present invention.
[0027] FIG. 6 is a perspective view of an actuation arrangement
constructed according to a further alternative embodiment of the
present invention.
[0028] FIG. 7 is a perspective view of an actuation arrangement
formed according to yet another alternative embodiment of the
present invention.
[0029] FIGS. 8A-8D are schematic illustrations of four alternative
skin-penetrations members formed according to certain embodiments
of the present invention.
[0030] FIG. 9 is a side view of an arrangement including a
skin-penetration member configured according to a first optional
embodiment.
[0031] FIG. 10 is a side view of an arrangement including a
skin-penetration member configured according to a second optional
embodiment.
[0032] FIG. 11 is a side view of an arrangement including a
skin-penetration member configured according to a third optional
embodiment.
[0033] FIG. 12A-12B are top and bottom views, respectively, of an
arrangement configured according to an optional embodiment.
[0034] FIGS. 13A-13C are bottom and side views, respectively, of an
arrangement configured according to an alternative embodiment.
[0035] FIG. 14 is a bottom view of an arrangement formed according
to a further alternative embodiment.
[0036] FIG. 15 is a bottom view of an arrangement formed according
to yet another optional embodiment.
[0037] FIG. 16 is a perspective view of another embodiment of an
arrangement formed according to the present invention.
[0038] FIGS. 17A and 17B are perspective views of yet another
embodiment of an arrangement formed according to the present
invention.
[0039] FIG. 18 is a schematic state diagram illustrating one
possible mode of operation of an integrated device formed according
to the present invention.
DETAILED DESCRIPTION
[0040] Exemplary arrangements and methods for the detection and
measurement of the presence and/or concentration of a target
analyte, such as glucose, bilirubin, alcohol, controlled
substances, toxins, hormones, proteins, etc., will now be
described.
[0041] According to certain embodiments, the current device is a
fully integrated, electromechanical system or device used in the
sampling and/or analysis of a bodily fluid. One possible body fluid
is whole blood and one possible analyte is glucose. The fully
integrated device of the present invention is much smaller than any
current commercially available semi-integrated, or multi-piece
glucose testing system, using blood as the analyte. The fully
integrated nature of the invention reduces the total number of
parts a user must carry to complete a test from about a minimum of
3-8 (lancet, lancer, test strip, calibration fluid, alcohol wipe,
carrying case, etc.) to 1-2 pieces (integrated device, optional
carrying case). A fully integrated device formed according to the
present invention requires little or no user intervention to carry
out testing. For example, the device may automatically perform
testing at predetermined intervals. Alternatively, the integrated
device can offer automatic single button operation that
significantly reduces the level of dexterity required for operation
compared with currently available systems. The device of the
present invention may comprise a reusable unit and a disposable
unit comprising a plurality of test subsystems. The device or
system may be wearable or may be hand held. The reusable portion of
the device may include a housing, an attachment mechanism, and a
user interface display. It may include an energy storage system,
mechanisms to facilitate the testing process including motors,
vacuum pumps, and mechanical stored energy systems. The reusable
unit or portion may also include microprocessors, and other
electronics in support of analyte quantification. The reusable
portion may also include optical systems for analyte
quantification. The reusable unit may include mechanisms for
indexing between multiple test sites, and may also include user
interface devices such as buttons, knobs, and microphones. The
device or system of the present invention may also include a
disposable portion. The disposable portion may include an array of
skin piercing elements attached to guides, triggers and/or
actuation mechanisms. The disposable portion may also include
mechanisms for transporting a sample of body fluid from the skin
surface into other areas of the device. According to certain
embodiments, at least a portion of the transport operation is
integrated into the skin-piercing element. The disposable portion
may also include analyte quantification members that may be
separate from or integrated with the transport member. The analyte
quantification members may be designed to optically or
electrochemically indicate detectable signals when exposed to the
analyte of interest.
[0042] The disposable portion may also include a skin-interfacing
member, possibly a soft silicone footprint. The skin interfacing
member can optionally be constructed of any material that
facilitates sample acquisition via conditioning the skin prior to,
during and/or after piercing. The skin interface may be included in
the reusable portion of the device.
[0043] The disposable portion may include an energy source. The
disposable portion may also include a housing designed to enclose,
and/or seal the analyte quantification members. The disposable
portion may also include mechanisms, or be designed to allow for
user-adjustable skin piercing depth. The disposable portion may
also include vacuum chambers as well as a means to provide an
airtight seal against the skin.
[0044] An integrated device or meter of the type described above is
illustrated in FIGS. 1A-1C. As illustrated therein the integrated
device 10 is discreet, portable, and wearable, and may generally be
in the form of a wristwatch. The device 10 includes an attachment
element or band configured to secure the device to the body or
wrist of the user. The device 10 further comprises a housing 14
that contains one or more of the components used for sampling
and/or analysis, as described above. The device 10 may further
comprise a disposable portion and a reusable portion, as further
described above.
[0045] According to the present invention, it is possible, but not
mandatory, to form the integrated device with a low height profile
to make the device as compact and discreet as possible. Thus,
according to the present invention, the actuator can be designed to
accelerate the skin-piercing element along a curved or rotational
path. This construction provides for a more compact height profile
of the device. Any suitable mechanism for accelerating the needle
along a curved or rotational path is contemplated. One such
mechanism is a torsional spring element. The integrated device or
meter 10 also includes a housing 16 formed of any suitable
material. One or more actuation posts, or triggers, 18 are fixably
mounted to a base plate 20 such that each one individually
constrains a spring actuator 22 in a cocked position such that the
spring is in such a state that it stores elastic energy. Skin
piercing elements 24, which may be in the form of lancets or hollow
needles, are mounted over the one or more actuation posts 18. Upon
release of a trigger element 18 the skin piercing element 24 is
driven into the skin of the user or wearer. The trigger may be
released by one of a variety of different physical means. The
trigger may be a bimetallic strip that, when heated, deforms enough
so that the spring retainer clears the trigger and is released. The
trigger may alternatively be a fuse such that when current is
passed through it, it breaks causing the actuator to be released.
The device or arrangement 10 may be constructed such that each
individual skin-piercing element 24 is provided with its own
actuator 22. Optionally, the actuator 22 may be provided in the
form of a torsional spring, as illustrated.
[0046] The actuator spring elements 22 may be provided to the user
in a pre-cocked position, as illustrated in FIG. 1B. The
acceleration path of the skin-piercing element or needle 24 may
begin up to 180 degrees from the angle of impact with the skin S of
the user. According to one beneficial aspect, the pivot point of
the actuator or torsional spring elements is provided as close as
possible to the plane lying on the surface of the skin S in order
to ensure that the skin piercing element 24 strikes the skin S at
an angle a which is as close to 90 degrees as possible. The
torsional spring elements 22 act as a guide for the skin-piercing
element or needle 24 to that locates the end 24e in the body fluid
sample after actuation so as to draw the body fluid into the lumen
24.LAMBDA., of the needle. In this regard, the actuator or
torsional spring elements 22 may be designed such that its neutral
position will locate the end 24e of the skin-piercing element 24 in
the opening created by the skin piercing operation at, above, or
below the surface of the skin S. Preferably, the torsional spring
elements may be designed such that a small spring bias urges the
skin-piercing element or needle 24 into the opening at or below the
surface of the skin S.
[0047] Another advantage of this aspect of the present invention is
that the actuator torsional spring elements 22 do not require a
positive stop to limit the penetration depth of the skin-piercing
element 24. It has been observed that elimination of a hard stop
may provide certain beneficial effects. Namely, it has been
observed that devices that include a hard stop experience a shock
and resulting vibration and/or stirring action when the stop is
impacted. It is theorized that this motion may increase the
observable wound and/or the perceived pain associated with
sampling. According to this embodiment, the depth of penetration of
the skin-penetrating member 24 is determined by a number of
factors, including the design of the sharp, the actuation force and
the skin's resistance to penetration at the chosen sampling site,
and the height that the skin is raised up (if any) by application
of a vacuum catalyst.
[0048] When the skin piercing element 24 is in the form of a needle
having an inner passageway or lumen 24.LAMBDA., an analyte
quantification member 26 that may comprise an assay pad 28 is
provided in communication with the lumen 24.LAMBDA. of the needle
such that the quantification member can receive a sample of blood
produced by the piercing of the user's skin with the needle. The
quantification member 26 can be in optical communication with a
detector array 30 that reads a color change on the assay pad or can
be an electrochemical means according to an alternative
embodiment.
[0049] One possible modification of the arrangement 10 is
illustrated in FIG. 2. As illustrated therein, an arrangement 40 is
similar to the previously described arrangement 10, except that the
skin piercing elements or needles 24 are oriented in a
circumferential manner, as opposed to the generally radial
orientation of the arrangement 10. As illustrated therein, the
actuators or torsional spring elements 22 are mounted to triggering
members 42 that, according to the illustrated embodiment are in the
form of a rotary post or spindle. This arrangement can work with a
variety of triggers. In the current embodiment, each spring has a
trigger that trips the cocked spring thus releasing the leg holding
the needle and causing the needle to accelerate. The triggering
members 42 may comprise a rotational actuator such as a
piezoelectric motor similar to the MiniSwis miniature piezo motors
(e.g., model 6 TRAPEZ 4 V1). This motor can rotate an arm to trip a
lever that holds the spring in the cocked position. Furthermore,
according to certain alternative embodiments, the rotational
piezo-motor may advance in the opposite rotational direction to
catch the spring in order to dwell the skin-piercing elements or
needle in the body fluid sample so that the body fluid may travel
up into the lumen 24.LAMBDA. via capillary action.
[0050] Another possible modification of the arrangement 10 is
illustrated in FIG. 3. As illustrated therein, an arrangement 50 is
similar to the previously described arrangements (10, 40), except
that the skin piercing elements or needles 24 are oriented in a
linear manner, as opposed to the generally radial orientation of
the arrangement 10, or circumferential manner of the arrangement
40. As illustrated therein, the actuators or torsional spring
elements 22 are mounted to pivot member(s) 52. This arrangement
accommodates a variety of different trigger mechanisms such as
fusible links, bimetallic strips, rotating cams, etc.
[0051] According to certain embodiments of the present invention, a
single actuator mechanism (e.g., a motor) can index to drive one or
more selected skin piercing members that form part of an array into
the skin (see, e.g., FIG. 5). Other alternative embodiments include
one actuator per skin piercing member (see, e.g., FIG. 18).
[0052] According to alternative embodiments of the present
invention, certain actuators that are contemplated can cause the
driven skin-piercing element (or needle) to rapidly oscillate,
re-enter or repeatedly penetrate the skin at the sampling site. The
number of penetrations per actuation or sampling event can vary
between 2-20 times. The frequency of oscillation of the
skin-piercing element may vary and can be on the order of 200-600
Hz. It has been observed that such oscillation does not appear to
produce an increase in the observable wound or perceived pain by
the user. The skin-piercing element may be driven at any suitable
speed.
[0053] The invention described herein suggests that the
skin-piercing member can be driven into the skin by some controlled
force. There are several embodiments of actuators that can perform
this function including torsional springs, compression springs,
cantilever beams, linear voice coils/solenoids, pneumatic
cylinders, as well as others. A torsional spring embodiment has
been described above. Additional, exemplary embodiments of such
actuators are illustrated in FIGS. 4-7.
[0054] FIG. 4 illustrates a device or arrangement 60 formed
according to the principles of the present invention. As
illustrated in FIG. 4, the device or arrangement 60 includes a
housing member 62. The housing member 62 can be constructed of any
suitable material, such as a polymer or metal. The housing 62 is
preferably constructed such that it forms part of a discrete
wearable or hand held device. The device may generally be in the
form of a wristwatch. Within the housing 62 there is disposed a
relatively rotatable camming or ramping surface 64. The device or
arrangement 60 further includes a guide element or plate 64. A
skin-piercing element 66, such as a hollow needle, is disposed such
that it may travel through the guide element or plate 64. An
actuator 67, such as the illustrated coil spring, is also disposed
within the housing 62. The actuator or coil spring 67 interacts
with the relatively movable camming or ramping surface 68 such that
the energy stored in the actuator or coil spring 67 is released
when a predetermined release point formed along the rotating
camming or ramping surface 68 is reached. This released stored
energy is then transferred to the skin-piercing element 66 such
that it is driven into the skin of the user or wearer of the
device. As further illustrated in FIG. 4, the skin piercing element
66 may be provided with an analyte quantification member 69, of the
type previously described. The quantification member 69 may include
suitable quantification media for analysis of the body fluid sample
received therein. Such media may include one or more chemical
reagents that react with an analyte present in the sample, thereby
producing a detectable signal, as discussed herein. Alternatively,
an electrochemical media may be utilized, such electrochemical
media per se being well known in the art.
[0055] An additional alternative embodiment is illustrated in FIG.
5. The device or arrangement 70 illustrated in FIG. 5 includes a
housing member 71 also formed of any suitable material, such as
those described above, and which also may form part of an overall
wearable and discrete device. A movable or rotatable surface 72 is
provided within the housing 71. A break 73 is formed along this
relatively movable or rotatable surface 72. An indexing element 74
is mounted within the housing. A release member 75 may be disposed
on the indexing member 74. As the actuation release member 75 comes
into registry with the break 73 and the relatively movable or
rotatable surface 72, the stored energy contained in an actuator or
spring member 76 can then be released, driving a skin piercing
element 77 into the surface of the skin of the user or wearer.
According to the illustrated embodiment, the skin-piercing element
77 is in fluid communication with an analyte quantification member
78 of the type previously described. Further, the spring member 76
can be formed as a cantilevered spring arm that provides the stored
spring energy which, when released as the described above, drives
the skin piercing element 77 into the surface of the skin. As
evidenced from FIG. 5, the device or arrangement 70 includes a
single actuator that is movable, and indexes with individual
skin-piercing elements.
[0056] A further alternative embodiment of the present invention is
illustrated in FIG. 6. The arrangement 80 of FIG. 6 includes a
first arm 82 upon which is mounted a skin-piercing element 84, such
as a hollow needle or a lancet. In the illustrated embodiment,
skin-piercing element 84 is a hollow needle. The skin-piercing
element 84 may be provided in fluid communication with an analyte
quantification member 86 of the type previously described. A second
mounting arm 88 is disposed above the first arm 82, as illustrated.
Attached to the end.cndot. of the mounting arm 88 is a weight 89,
which can be driven into the skin piercing element 84, thereby
driving the skin-piercing element 84 into the surface of the skin
of the user or wearer. Varying the mass of weight 89 attached to
the mounting arm 88 and/or the vertical displacement of the weight
relative to the first arm can control the magnitude of the driving
force behind the skin-piercing element 84. It should be understood
that constructions where each skin-piercing element
84/quantification member 86 combination may have their own
individual second mounting arm 88/weight 89 associated therewith,
and constructions where a single second arm 88/weight 89 is
moveable to index with each skin-piercing element 84/quantification
member 86 combination are both contemplated by the present
invention.
[0057] The driving element may be another type of actuator besides
a beam such as, a coil spring, solenoid, voice coil, or any other
type of mechanism that can accelerate to enough momentum to impact
or push the skin-piercing element such that it penetrates the skin
to the proper depth.
[0058] An additional illustrative embodiment is depicted in FIG. 7.
This embodiment includes an arrangement 90 that uses a cantilever
beam 92 actuator triggered via a cam/ramp system 94. In this system
a motor or spring (not shown) rotates a cam 94 that has a
specifically designed ramp path 96. As the cam 94 rotates the beam
92 rides up the cam 94, once the beam 92 has been lifted to the
desired height the beam comes into communication with a break 98 in
the ramp path 96 and beam 92 is released. In one embodiment the
device is laid out such that after one beam is triggered the cam 94
continues to rotate and the next beam 92 is lifted and released.
This pattern continues until after complete revolution all of the
sites have been fired. In another embodiment each revolution of the
cam 94 lifts and releases a single cantilevered beam 92. This
single beam 92 is indexed to drive every skin-piercing element 99
into the skin.
[0059] Another alternative embodiment uses small stepper motors
that rotate to release a latch. Specifically a small stepper motor
is attached to a rotating or flexible "arm" feature, as that arm
rotates it contacts a latch, knocks it off of its rest point and
releases the spring.
[0060] Yet another embodiment uses a nitinol switch that changes
shape when current is applied to it. As the shape of the trigger
changes the actuator is released. According to a further
embodiment, a breakable wire switch works on the concept that some
materials weaken when exposed to heat or current. A small section
of this material would be used to hold the actuator in the cocked
position. To release the actuator, a current is passed through the
wire. Similarly, heat can be applied to a thread-like material or
other material to sever the material by melting or burning.
[0061] According to the present invention, additional skin
penetration element embodiments are envisioned. For example,
several possible orientations for one or more bevel(s) formed at
the end of a skin penetration element or member, such as a lancet
or needle are contemplated. Four such alternatives are illustrated
in FIGS. 8A-8D. In the arrangement of FIG. 8A, the bevel(s) 100 of
the skin-penetration element or member are oriented facing forward,
as illustrated. According to the arrangement of FIG. 88, the
bevel(s) 102 are orient facing the backside of the skin-penetration
element or member. In the arrangement of Fig. BC, the bevel(s) 104
are oriented facing away from the surface of the skin S. According
to the arrangement of FIG. 80, the bevel(s) 106 are oriented facing
the surface of the skin S. According to the present invention, when
the actuator is chosen that drives the skin penetration member
along an arcuate or rotational path, it has been observed that a
bevel orientation that faces away from the surface of the skin, or
as illustrated in FIG. 8C as an "anti-scoop" configuration, may
result in a less visible wound.
[0062] Three additional alternative arrangements for producing a
sample of blood or body fluid by piercing the surface of the skin,
while minimizing the wound created therein, are illustrated in
FIGS. 9-11.
[0063] As illustrated in FIG. 9, an arrangement 120 may comprise a
skin-piercing element 122, such as a lancet or a hollow needle,
which is attached to an actuation member 124. According to the
illustrated embodiment, the actuation member is configured to drive
the skin-piercing element 122 along an arcuate or rotational path.
The a skin piercing element 122 and actuation member 124 can be
configured such that the skin piercing element forms an entry angle
.beta. of 90.degree.+/-20.degree.. The entry angle being defined,
as illustrated in FIG. 9, as the angle formed between the
longitudinal axis of the skin piercing element 122 and the plane
defined by the surface of the skin 126. Providing the arrangement
120 with an entry angle as described above has been observed as
minimizing wound formation. According to the arrangement 120, the
skin piercing element 122 is provided with a bevel 123 that is in
the anti-scoop orientation, or facing away from the surface of the
skin (see, e.g., FIG. 8C).
[0064] According to the arrangement 120, the skin-piercing element
122 and the actuation member 124 are configured and arranged such
that the path of travel of the end of the skin piercing element 122
after entry into the skin is not too shallow along its radius of
travel. In other words, according to one embodiment, the skin
piercing element 122 and the actuation member 124 are configured
and arranged such that the path of travel of the end of the skin
piercing element 122 after entry into the skin is closer to the
perpendicular, or a wider arc, as opposed to a travel path that is
more parallel to the surface of the skin 126.
[0065] An alternative arrangement 130 is depicted in FIG. 10. The
arrangement 130 has the same features and characteristics as the
arrangement 120 described above, except for the following
distinctions. According to the arrangement 130, a skin-piercing
element 132 is provided that has a bevel 133 that is oriented in a
"slice" configuration (see, e.g., Fig. SA). In other words, the
bevel 133 is rotated approximately 90.degree. away from the plane
defined by the surface of the skin 126.
[0066] A further alternative arrangement 140 is depicted in FIG.
11. The arrangement 140 has the same features and characteristics
as the arrangement 120 described above, except for the following
distinctions. According to the arrangement 140, a skin-piercing
element 142 is provided that has a generally arcuate or curved
shape. A skin-piercing element 142 having this arcuate or curved
configuration advantageously prevents in-plane forces with the skin
as it travels along an arcuate or curved path. The skin piercing
element 142 may be provided with a radius of curvature that
approximates the radius of curvature if its path of travel when
driven by the actuation member 144. The skin-piercing element 142
has a bevel 143 that is oriented in an anti-scoop orientation, or
facing away from the surface of the skin (see, e.g., FIG. 8C).
[0067] While a wearable integrated meter has several advantages
over current technology it is understood that there may be times
when the user is either unable or would prefer not to wear the
integrated meter. Examples of such situations include during
exercise, swimming, sleeping, or when social situations where the
style of the watch may be inappropriate. Thus, the present
invention also advantageously comprises a wearable meter that can
be converted into a handheld meter.
[0068] The compact size of the integrated devices of the present
invention allows the user to carry everything necessary to complete
a test in a small pocket. For example, if a user needed to attend a
formal dinner they most likely will not have space to carry all of
the components associated with currently available glucose testing
systems. These users will likely take a health risk and ignore
testing during the event. The size of the integrated devices of the
present invention allows the user to carry the entire device in
their pocket and test discreetly in a restroom, or even beneath the
table on their lap.
[0069] Integrated wearable devices according to the present
invention that can be converted to a hand held device also allow
the user to test at a digit or the fingertip if needed or desired.
While testing at an alternate site such as the wrist is safe and
accepted during certain hypoglycemic incidents, it is still
advantageous for the user to be able to test at the finger to get
an even more accurate glucose reading. Also, regardless of
increased pain and other factors, some users may prefer to test at
a digit or the fingers regularly and only occasionally wear the
device for convenience. The present invention provides for such
usage.
[0070] The following features facilitate usage of convertible hand
held integrated devices formed according to the present invention.
Thus, an integrated device formed according to the present
invention may also include one or more of the following
features.
[0071] According to one embodiment, the device is provided with a
footprint comprising a single opening for testing. The user
operates the device upside down by placing their fingertip on top
of the footprint, or the user operates the device face side up and
locates their fingertip under the footprint. For upside-down
operation the device may have alerts that are not visible, for
example tactile (vibrations, heat, etc.), or audible alerts. These
alerts can be used to inform the user that a test is about to begin
and to notify the user that a test is complete. To further simplify
operation the device can have an "on-demand finger test" trigger on
the device. This trigger will allow the user to initiate a test
without having to look at the top face of the device. For example,
the user may remove the watch from their wrist press a button or
combination of buttons that place the system into finger test mode.
In this state, the finger test trigger would be in the active
state. The user could then turn over the device and use it without
looking at the topside of the device. Potential triggers include
buttons, pressure sensors, capacitive sensors and other commonly
known input mechanisms. It is also possible to have the finger
trigger activate as soon as it detects that a finger is placed on
it for a set period of time. This will eliminate the need to change
the device to "finger mode", thereby simplifying the testing
process. Another embodiment comprises a footprint having multiple
openings that can be used to complete a finger test, and allows the
user to complete a test while still looking at the top face of the
device. With this construction, the user will have to correctly
identify the opening upon which to place their finger. Several
features are contemplated to assist with testing in this
manner.
[0072] The top face of the device can have features that point the
user to the proper location for the current test. Such features can
be visible indicators, such as LED's, around the perimeter of the
device that correspond to each opening in the footprint. For
example, before a test the corresponding LED will illuminate,
guiding the user to the correct position under the device.
[0073] Visual indicators, such as the above-mentioned LED's, can
also be used below the device to illuminate the targeted sampling
site and allow the user to correctly position the device. These
LED's would have the added benefit of allowing the user to
correctly place the device in a poorly lit environment. Another
feature for guiding the user to the correct location for a test is
to have the display of the device display an arrow that points to
the correct position or opening in the footprint for a test.
[0074] Each footprint can include a sensor (pressure, switch,
capacitive, thermal, etc.) to determine that a finger is present.
The device would be able to fire any of the actuators at any time,
so when the user places their finger under an opening in the
footprint, an actuator would fire and a test would be completed. If
the user placed their finger under an opening in the footprint that
had already been used, the device could detect that and tell the
user to move their finger to another site.
[0075] According to a further alternative, certain openings in the
footprint may be reserved for finger testing. These openings would
be easily identifiable by site or touch, allowing the user to
accurately position their finger for a test.
[0076] In one embodiment, a device such as the one illustrated in
FIG. 1A-18 can be converted from a wearable to a handheld device by
simply opening the strap that attaches the device to the user's
wrist. That is this device 10 is designed such that the functional
portion 14 of the device 10 can operate without being attached to
the user. For instance if the device 10 was designed to be worn at
the wrist, and the user wanted to use the device as a handheld
monitor, the user would simply open the band 12 holding the device
10 on at the wrist and place the functional portion 14 of the
device 10 on the location they wished to test, forearm, finger,
palm, thigh, etc. The user would then be able to reattach the
device to their wrist, or place the device 10 in a pocket or other
location until needed again.
[0077] Alternative embodiments of the present invention are
illustrated in FIGS. 12A-15. As illustrated therein, an arrangement
150 generally comprises an integrated device 152 of the type
described above. The integrated device 152 includes a top face 154
which may include a display and one or more buttons 156. The
integrated device 152 also comprises a bottom face 158 defining a
footprint comprising one or more openings 160 through which a
skin-piercing element may extend. An attachment element, such us a
strap 162 may be provided to attach the device to a suitable
location on the wearer, such as the wrist. A quick release
mechanism 164 is provided which permits removal of the attachment
element 162 from the integrated device 152. Any suitable quick
release mechanism 164 is contemplated.
[0078] One such suitable quick release mechanism 164 is illustrated
in FIGS. 13A-13C. According to the illustrated embodiment, the
quick release mechanism 164 comprises a generally cylindrically
shaped portion 166 which is received within a generally C-shaped
portion 168 in a snap-fit type connection.
[0079] Another alternative quick release mechanism is illustrated
in FIG. 14. As illustrated therein, the quick release mechanism 164
comprises a hollow generally cylindrically shaped portion 170
disposed on the ends of the band 162. The portions 170 on the ends
of the attachment means or band 162 are concentrically received
within complimentary hollow generally cylindrically shaped portions
172 disposed on the ends of the integrated device 152. A clip 174
is then inserted within the cylindrically shaped portions 170 of
the band 162. The clip 174 includes a locking feature 176 disposed
at one or more ends of the clip 174 for releasably securing the
clip 174 once inserted all the way through the cylindrical portions
176. The locking feature 176 may take any suitable form, such a
collapsible detent.
[0080] According to a further embodiment, the quick release
mechanism 164 may take the form of that illustrated in FIG. 15. As
illustrated in FIG. 15, the hollow cylindrical portions 170
disposed at the ends of the band 162 are provided with a threaded
end 178. A pin 180 having a threaded end 182 is received within
hollow cylindrical portions 172 provided at the ends of the
integrated device 152, as well as the hollow cylindrical portions
170 disposed at the ends of the band 162. A pin 180 is then rotated
such that the threaded end 182 thereof mates in threaded engagement
with the threaded end 178 of the hollow cylindrical portions 170,
thereby securing the integrated device 152 to the band 162 in a
releasable fashion.
[0081] An arrangement constructed according to a further
alternative embodiment of the present invention is illustrated in
FIG. 16. As illustrated therein, the arrangement 190 includes a
separate carrying case 192 which is configured to receive the
integrated device 152, once removed from the attachment element or
band 162. It should be understood that the case 192 may also be
utilized with any of the previously described embodiments. The
arrangement 190 further includes an alternative means for
separately retaining the integrated device 152 and the band 162. As
illustrated therein, the band 162 formed as a one piece member
comprising a recess or pocket 194 disposed therein for housing the
integrated device 152 in a releasable manner. Any suitable
mechanism may be provided to releasably secure the integrated
device 152 within the recess or pocket 194. Suitable mechanisms
include a friction fit, snaps, detents, and releasable fasteners.
The provision of a case 192 according to the present invention
advantageously protects the footprint, and the integrated device
192 as a whole, from damage. The case also may help to prevent bio
hazardous materials (e.g., blood) from spreading if the device is
laid on a surface. An additional benefit of the case 192 that it
may contain an additional power source, motor, or other components
that may assist in operation of the integrated device 152.
[0082] As an alternative to the separate case 192, a similar
protective feature or features may be integrated into the device
152. For example, the device 152 is separated from the band 162,
the device 152 may be provided with a rotatable plastic shield 193,
which can be rotated into a position which covers the openings 160
in the footprint 158. When the user is ready to use the device, the
plastic shield 193 is rotated again until the openings 160 and
footprint 158 are accessible. According to a further alternative, a
plastic shield 193 can be configured such that it will cover all
but one of the openings 160. This enables the entire device to be
evacuated and the remaining open footprint sealed against the
user's skin, such as by application of a vacuum. This embodiment
advantageously facilitates the use of a vacuum in conjunction with
sampling, and eliminates the need to isolate each individual
chamber against vacuum leaks.
[0083] A further alternative embodiment of the present invention is
illustrated in FIGS. 17A-178. As illustrated therein, the
arrangement 200 comprises an integrated device 152 of the type
described above which includes a housing 202. The housing 202 is
separable from the attachment element 162 via any suitable
mechanism, such as the illustrated recess 204 which is designed to
receive a coin or tool therein which is then twisted by the user to
separate the housing 202 from the attachment element 162. The
housing 202 can then be inserted into a separate handheld device
206. According to this embodiment, the housing 202 contains the
skin-piercing elements, reagents, and other components. Both the
reusable portion of the integrated device 152, as well as the
handheld unit 206 contain controls, a display, power supply,
optics, and other components necessary to carry out the test.
According to this arrangement, a user can buy a number of
disposable housing or units 202 which are usable in either a
discrete wearable device, or a handheld device.
[0084] In order to facilitate use of the handheld device for finger
testing, the handheld device 206, or the separate case 202, may be
provided with a feature for accurately positioning the finger for
testing such as footprint area 208 which may include a groove or
channel in which the user can lay their finger. The device can be
designed such that the unit then rotates until an available test
site is aligned with the opening disposed in the recess or channel
in registry with the user's finger.
[0085] Certain modes of operation of an integrated device or meter
of the type described herein are also contemplated by the present
invention.
[0086] Before any testing can occur the user opens all the
packaging and inserts a disposable unit into the wearable or hand
held device. The disposable portion or unit may be attached via
several mechanical methods including threads, screws, snaps,
etc.
[0087] After a disposable is loaded, the device prepares itself to
initiate a test. Preparations may include reading the calibration
codes on the disposable portion, measuring a controlled calibration
fluid, and/or other self checks. During startup the device may also
prompt the user to schedule test intervals. The user should now
place the device on their body, possibly the wrist, optionally
using an attachment means.
[0088] When it is time for a scheduled test, or the user requests a
test, the device begins test preparations. The device may give user
an indication that a test is imminent; the indication may be
visual, audible, tactile or a combination of indicators. If
necessary, the device will index to the next available test setup
location. The indexing may be via a motor driven mechanism or
stored mechanical energy. The device may now cock the skin piercing
member. The device may now test to ensure skin contact. The device
may now initiate a catalyst process. Catalyst processes are
intended to increase fluid sample availability and production at
the sampling site.
[0089] At this point a trigger releases the actuation mechanism and
drives the skin piercing member into the skin.
[0090] After piercing the skin the device begins to transport the
fluid or blood to the quantification media. Once the sample arrives
at the quantification media, a reaction occurs. This reaction is
measured to produce an analyte reading. Once a sufficient sample
volume is delivered to the quantification media, the catalyst
process may be terminated. The device may now output a reading to
the user. When it is time for the next test the process is
repeated. If the testing fails, the device may automatically repeat
a test. The device will inform the user of remaining number of
tests. When all tests are used the device will prompt user to load
a fresh disposable unit.
[0091] According to one illustrative embodiment of the present
invention, an integrated device is operated according to the state
diagram contained in FIG. 18. At least the following operations are
illustrated therein.
1) A start switch closure starts off the sequence. 2) The vacuum
pump turns on. 3) When the vacuum set point is reached, the vacuum
is maintained for a vacuum hold period (nominally set to 5
seconds). This catalyst increases blood production to a
practical/usable amount. 4) The trigger releases the sharp
immediately after the "vacuum hold" is completed. 5) A spring
settling delay state allows the spring to settle in a fixed
position before the CMOS sensor can read parameters required for
KIS calculation and subsequent glucose levels. This delay does not
start until the trigger is released. The reasons for this is that
the release of the trigger could potentially move the assay pad and
produce an unwanted spatial error on the black or white reference
signals. 6) A black read is performed, typically with the reagent
LED illumination extinguished. 7) The reagent LED illumination is
then turned on. 8) A white read is done. 9) The scanning wet read
puts the CMOS image results into a database. 10) The vacuum is
released upon acquisition of a sufficient volume of sample detected
by the CMOS image detector. 11) A KIS and/or glucose concentration
calculation then takes place. 12) The reporting state displays the
result of the above calculation or any errors that may exist. 13)
Several errors can be trapped, and in most cases, abort the
sequence. Such errors include things like insufficient vacuum, loss
of vacuum, unexpected white read value and other user aborts. 14)
The glucose concentration is not displayed until the chamber is
within 0.5 in. Hg. This keeps blood from blowing unnecessarily into
the chamber, thus requiring a major cleanup. 15) The last state
simply waits for the next start button closure.
[0092] It should be understood, that consistent with the principles
of the present invention and in connection with the exemplary mode
of operation illustrated in FIG. 18, one or more of the
above-described actions may be omitted, modified, or the order in
which they are performed can be altered from the illustrated
embodiment described above. In addition, one or more additional
actions other than those listed above can be added to the
illustrated embodiment.
[0093] An exemplary body fluid sampling and analysis methodology or
technique, which may be utilized in conjunction with any of the
above-mentioned devices or integrated meters, but is not
necessarily limited thereto, is described as follows.
[0094] A user loads a fresh disposable cartridge containing a
plurality of skin penetration members and analysis sites into an
integrated meter. The integrated meter then reads calibration data
contained in or on the cartridge. This data can be read in any
suitable manner. For example, a bar code may be placed on the
cartridge which can be optically read by the optical assembly
contained within the meter. The integrated meter then selects the
proper lookup table or algorithm to calculate an aggregate glucose
measurement taking into consideration the calibration data. The
meter may then place itself in a ready mode waiting for a trigger
to initiate sampling and testing. The user then either manually
presses a button or trigger to initiate sampling and analysis, or
the device verifies that it is properly positioned on the skin of
the user and ready to begin the sampling and analysis procedure.
Suitable sensors to accomplish this include optical, capacitive or
pressure sensors. The device then initiates a catalyst which acts
to facilitate the expression of body fluid. According to one
alternative embodiment, the catalyst is an inflatable member that
exerts pressure on a digit. Alternatively, the catalyst is vacuum
pressure which generates suction at the sampling site. Sensors
present in the meter may be used to monitor and control the
positive or negative pressure of the catalyst. After achieving a
target pressure for a desired period of time, the skin penetration
member (e.g., a hollow needle) is actuated and driven into the skin
of the user to create a wound site. The skin penetration member
comes to rest in or directly on the wound created at the sampling
site where it is in the desired position for collecting a sample of
body fluid expressed from the wound. The integrated meter may
further include a mechanism for detecting a whether a sufficient
amount of sample has been expressed. Details of such suitable
detection techniques are described in detail in U.S. Pat. No.
7,052,652, entitled ANALYTE CONCENTRATION DETECTION DEVICES AND
METHODS, the entire content of which is incorporated herein by
reference. Once the desired amount of body fluid has been obtained,
the catalyst may be deactivated. A sample of body fluid is in fluid
communication with a device or mechanism which creates a detectable
signal upon reaction within analyte present in the sample body
fluid. For example, one such suitable mechanism is a absorbent pad
containing a chemical reagent which, upon reaction with the analyte
produces a reaction spot which can be optically detected. An
optical assembly which is in optical communication with the above
described signal generating mechanism is utilized to detect the
signal created via reaction with the analyte and communicate the
signals to supporting electronics contained within the meter. The
concentration of a target analyte (e.g., glucose) can then be
calculated using these signals as a basis. Additional factors may
be considered during these calculations, such as the sample size,
levels of other substances contained in the sample (e.g.
hematocrit), etc. Such optional calculation techniques are
described in further detail in U.S. patent application Ser. No.
11/239,122, entitled ANALYTE DETECTION DEVICES AND METHODS WITH
HEMATOCRITNOLUME CORRECTION AD FEEDBACK CONTROL, the entire content
of which is incorporated herein by reference. These calculations
quantify the amount of analyte contained in the sample body fluid.
This quantity is displayed on a suitable display contained within
the meter which can be easily read by the user. The integrated
meter then automatically indexes the disposable cartridge to
present a fresh unused skin penetration member which will be
utilized to perform the next sampling and analysis event.
[0095] Numbers expressing quantities of ingredients, constituents,
reaction conditions, and so forth used in this specification are to
be understood as being modified in all instances by the term
"about". Notwithstanding that the numerical ranges and parameters
setting forth, the broad scope of the subject matter presented
herein are approximations, the numerical values set forth are
indicated as precisely as possible. Any numerical value, however,
inherently contains certain errors necessarily resulting from the
standard deviation found in their respective measurement
techniques. None of the elements recited in the appended claims
should be interpreted as invoking 35 U.S.C. .sctn.112, 1{6, unless
the term "means" is explicitly used.
[0096] Although the present invention has been described in
connection with preferred embodiments thereof, it will be
appreciated by those skilled in the art that additions, deletions,
modifications, and substitutions not specifically described may be
made without department from the spirit and scope of the invention
as defined in the appended claims.
* * * * *