U.S. patent application number 13/763483 was filed with the patent office on 2013-06-20 for body fluid monitoring and sampling devices and methods.
This patent application is currently assigned to Intuity Medical, Inc.. The applicant listed for this patent is Intuity Medical, Inc.. Invention is credited to Jeffrey L. Emery, Raul Escutia, Jeffrey M. Jones, Craig M. Litherland, Gregory C. Loney, Michael F. Tomasco.
Application Number | 20130158432 13/763483 |
Document ID | / |
Family ID | 39136508 |
Filed Date | 2013-06-20 |
United States Patent
Application |
20130158432 |
Kind Code |
A1 |
Escutia; Raul ; et
al. |
June 20, 2013 |
BODY FLUID MONITORING AND SAMPLING DEVICES AND METHODS
Abstract
An integrated monitoring and body fluid sampling device
constructed to permit digital as well as alternate-site body fluid
sampling and analysis, the device comprising: a housing; at least
one skin-penetration member; and a member constructed for the
application of circumferential or vacuum pressure to an appendage;
wherein the member is detachably or retractably connected to the
housing in a manner such that the integrated monitoring and body
fluid sampling device can perform digital or alternate-site body
fluid sampling and analysis. Additional arrangements and techniques
are also described.
Inventors: |
Escutia; Raul; (Sunnyvale,
CA) ; Emery; Jeffrey L.; (Redwood City, CA) ;
Litherland; Craig M.; (Cupertino, CA) ; Jones;
Jeffrey M.; (Sunnyvale, CA) ; Loney; Gregory C.;
(Los Altos, CA) ; Tomasco; Michael F.; (Morgan
Hill, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Intuity Medical, Inc.; |
Sunnyvale |
CA |
US |
|
|
Assignee: |
Intuity Medical, Inc.
Sunnyvale
CA
|
Family ID: |
39136508 |
Appl. No.: |
13/763483 |
Filed: |
February 8, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11510784 |
Aug 28, 2006 |
8372015 |
|
|
13763483 |
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Current U.S.
Class: |
600/583 |
Current CPC
Class: |
A61B 5/15125 20130101;
A61B 5/15161 20130101; A61B 5/15113 20130101; A61B 5/15109
20130101; A61B 5/150022 20130101; A61B 5/15123 20130101; A61B
5/150389 20130101; A61B 5/150099 20130101; A61B 5/150068 20130101;
A61B 5/150503 20130101; A61B 5/157 20130101; A61B 5/15117 20130101;
A61B 5/15151 20130101; A61B 5/150358 20130101; A61B 5/150748
20130101; A61B 5/1411 20130101 |
Class at
Publication: |
600/583 |
International
Class: |
A61B 5/15 20060101
A61B005/15 |
Claims
1.-38. (canceled)
39. A method for sampling a body fluid from a digit: positioning
the digit between a first arm and a second arm of a catalyst
device; moving the digit relative to the catalyst device to apply
pressure to the digit with the catalyst device near a sampling site
of the digit; and piercing the sampling site with a skin
penetration member of a sampling device to collect a sample of the
body fluid.
40. The method of claim 39 wherein the sampling device comprises a
housing, wherein the housing comprises a footprint.
41. The method of claim 40 further comprising positioning the digit
relative to the footprint.
42. The method of claim 39 wherein the catalyst device comprises a
U-shaped channel comprising the first and second arms.
43. The method of claim 39 wherein the sampling device comprises a
mechanism for moving the catalyst device relative the digit, and
wherein moving the digit relative to the catalyst device comprises
moving the catalyst device with the mechanism.
44. The method of claim 43 wherein the mechanism comprises a motor
and a linkage connecting the catalyst device to the linkage.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to devices, arrangements and
methods involving body fluid sampling with the assistance of a
catalyst. In certain embodiments, the present invention is directed
to integrated monitoring and body fluid sampling devices and
methods that permit both digital and alternative-site body fluid
sampling and analysis.
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, and the risk of
developing type I juvenile diabetes is higher than virtually all
other chronic childhood diseases.
[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. The systems
require significant user intervention.
[0005] Technology development in the field of self-monitoring of
blood glucose has placed the burden of acquiring sufficient blood
for conducting a test on the user of the technology. Historically,
diabetics have been taught to lance their finger tips to produce
blood for conducting the test. Ironically, the fingers are not only
one of the most sensitive body parts to pain, but they also are
among the areas of skin that are most highly perfused with blood.
Earlier versions of consumer-oriented self-monitoring products
usually required many microliters of blood, and the finger tips
provided a reasonably convenient area to lance that would be most
likely to produce the required volume of blood.
[0006] More recently, some self-monitoring systems offer the option
to the user to test at alternate sites such as the palm, forearm,
or thigh. While these sites are generally known to be significantly
less sensitive to the pain associated with lancing, the adoption of
alternate site testing has been limited for at least four reasons:
1) only a few meter products have been approved by the FDA for
testing at alternate sites at this time; 2) many testers do not
know that they can use their device at the alternate sites; 3) many
testers find it relatively difficult to express sufficient blood at
the alternate sites to perform a test; 4) data published in medical
literature on some of the meters shows that there is a distinct
difference between glucose levels measured at alternate sites
relative to the finger, particularly when glucose levels are
falling and/or the subject may be hypoglycemic. Consequently, there
is a perception by the medical community that there may be an
increased risk for delayed or improper treatment by the diabetic if
they act only on the basis of glucose levels measured from
alternate sites. Thus, the finger lancing site remains the most
frequently used test site by far.
[0007] Lancing devices and the lancets themselves have also evolved
somewhat over the past few decades. Some lancing mechanisms may
produce relatively less pain by either 1) projecting the lancet in
and out of the skin in a more straight path and thus reducing
stimulation of percutaneous nerves which provide the pain stimulus;
and 2) offering depth control in the lancing device so that the
user may balance the expression of sufficient blood against the
level of pain. Furthermore, lancet manufacturers offer a variety of
lancet sizes, lengths, and tip bevel patterns with some companies
claiming that their lancet is less painful than others.
[0008] What remains clear is that the most testers, when lancing at
the finger, often must put down the lancing device and apply
pressure near the finger tip in order to produce sufficient blood
for the test strip in the meter. Many instructions for use with
conventional meter systems specifically prescribe that the user
perform this "milking" process because without it, many will not
spontaneously produce the required volume. Applicants have observed
this phenomenon in the use of commonly available commercial
sampling and meter systems. When a trained professional lanced the
finger tips of 16 volunteer diabetic subjects at the maximum depth
setting on commercially available device under controlled
conditions, only 15% of lanced sites spontaneously produced
sufficient blood for the meter to accurately measure glucose
levels.
[0009] An engineering model of the lancing wound and of the process
for expressing blood to the skin surface provides insight into why
the milking process is so often a requisite to successful testing
of blood glucose levels. The most commonly recommended site for
testing by self-monitoring meter manufacturers is the soft tissue
pad on the dorsal side of the distal finger tip. Once a wound is
created by the lancing device, a pathway in the soft tissue
communicates between the surface of the skin and the damaged blood
vessels below the epidermal skin layers. From the perspective of
engineering fluid dynamics, this pathway can be considered as a
pipe or channel between the reservoir of blood and the surface of
the skin.
[0010] This pipe, however, often does not remain sufficiently open
to permit adequate blood flow largely because of the elastic recoil
generated by the extracellular collagen in the skin. Fluid dynamics
predicts that a sufficiently large pressure differential must exist
across a pipe in order for flow to occur and that the requisite
pressure is elevated as the resistance across the pathway
increases. In the case of a lanced finger tip, the pressure
differential is the pressure of blood below the skin (typically no
more than .about.20 mmHg) relative to the pressure at the surface
of the skin (typically 0 mmHg). For most individuals this low
pressure gradient cannot overcome the resistance caused by the
tendency of the wound pathway to close.
[0011] The manual milking process incorporates two primary
biomechanical mechanisms which assist in the expression of blood to
the surface of the skin. First, the pressure applied to the soft
tissue near the lancing site increases the blood pressure below the
skin and elevates the magnitude of the pressure gradient across the
wound pathway. This is clearly visible in individuals with lighter
colored skin when the finger is compressed near the distal
phalangeal joint--the tissue color becomes redder as the capillary
bed near the skin surface becomes engorged with blood. With the
increased pressure gradient, increased blood flow is expected in
rough proportion
[0012] The second mechanism arises from the deformation of the skin
near the lancing site, which may tend to temporarily enlarge the
wound pathway with milking. Since the resistance to fluid flow in a
simple pipe or channel is proportional to the cross-sectional area
of the pathway. Thus, distension of the skin via applied pressure
may reduce the wound pathway resistance and enhance blood
expression to the skin surface.
[0013] Attempts have been made in the past to take steps toward
automation of the testing process at alternate sites. 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. This meter, however, is
no longer available on the market.
[0014] A device similar to the Soft-Tact 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, and fails to describe a catalyst (i.e.--mechanism to
stimulate or enhance expression of blood from the lanced wound
site) that ensures that a sufficient sample is expressed from the
wound.
[0015] 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 that the device requires two
hands for operation. Specifically, the user must hold the device in
one hand while testing a finger on the other hand.
[0016] Another disadvantage of the device disclosed above is that
for the device to function properly the user must be able to resist
the downward force created by the motor/spring driven pressure
applications system. In other words, as the device applies a
downward force to create pressure around the target site the user
must be able to hold the device flush against the skin for it to
operate properly. This may present a problem for some elderly or
disabled users who may not have the strength to hold the device in
place as a test is performed.
[0017] Another disadvantage of the device described above is that
the devices applies a force via a downward "telescoping" mechanism.
A piston-like ring is pressed into the user's skin to aid in sample
extraction. This type of pressure catalyst does not trap the
maximum amount of blood proximal to the lancing site and thus does
not generate a sufficient sample within the target area.
[0018] Thus, conventional finger tip sampling devices and methods
are overly reliant upon user-dependent milking in order to
consistently express a sufficient quantity of blood from the wound
site.
[0019] Moreover, there is no self-monitoring system currently
available that integrates the steps of lancing, expression of body
fluid, transport of body fluid to the quantification apparatus, and
quantification of the analyte at the finger tip in a fully
automatic way. While many diabetics continue to test their blood
glucose levels with blood from the finger, testing at the alternate
sites offers the advantage of significantly less pain when lancing
the palm, forearm, etc. Thus, it would be advantageous to have an
automatic and fully integrated meter constructed for testing at
both the finger and the alternate sites.
SUMMARY OF THE INVENTION
[0020] 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 both digital and
alternative-site body fluid sampling and analysis.
[0021] 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.
[0022] 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.
[0023] As used herein, "body fluid" encompasses whole blood,
intestinal fluid, and mixtures thereof.
[0024] 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.
[0025] The current invention may include removable attachments that
are specific for either digital or the alternate site testing. The
attachments may include a site-specific catalyst to facilitate
reliable blood expression. For example, these attachments
incorporate either an automatically applied pressure catalyst for
the finger, or an automatically applied vacuum catalyst for the
alternate site.
[0026] Advantages of the present invention may optionally include
one or more of the following: [0027] Improved body fluid sampling
consistency and relability when sampling and/or testing at either
the digits or an alternative site. [0028] The flexibility of
testing at a variety of locations in a variety of orientations with
a single integrated meter; [0029] Adoption of this technology being
facilitated by the familiarity diabetics have with many lancing
devices that are capable of obtaining blood at the finger or
alternate site via site-specific interchangeable skin interface
components; [0030] It can leverage the same mechanism, e.g., a
pump, for generating the catalyst for blood expression at either
the digits or alternate sites; [0031] The potential use of
interchangeable attachments that are simple, low cost, and easy to
manufacture; and [0032] Design of the attachment make them easy to
use, easy to attach and detach, and easy to clean.
[0033] According to certain optional aspects, the primary meter
component contains the technology for lancing, transporting, and
quantifying the analyte with the blood. The primary meter component
may also contain a pump, which facilitates the automatic blood
expression via site-specific attachments. For the digits, blood
expression may optionally be achieved by directing pressurized air
from the pump to a cuff situated at an area proximate to the
sampling site. For alternate sites, blood expression may optionally
be achieved in the alternate-site attachment by pumping air from
and creating a vacuum at the lancing area.
[0034] According to one aspect, the present invention is directed
to an integrated device, the device comprising: a housing; at least
one skin-penetration member; and a member constructed for the
application of circumferential or vacuum pressure to a sampling
site, wherein the member is detachably or moveably connected to the
housing in a manner such that the integrated device can perform
digital or alternate-site body fluid sampling and analysis.
[0035] According to another aspect, the present invention is
directed to an integrated device, the device comprising: a housing;
a first footprint and a second footprint disposed on the housing,
the first and second footprints constructed to be applied to a
sampling site on the skin of a user during body fluid sampling; a
plurality of skin-penetration members contained within the housing,
a first and second of the plurality of skin penetration members
being in registry with the first and second footprint,
respectively; and a member constructed for the application of
circumferential pressure to the sampling site wherein the first
footprint is constructed and arranged for sampling body fluid from
a digit, and the second footprint is constructed and arranged for
sampling body fluid from an alternate site on the body of the
user.
[0036] According to a further aspect, the present invention is
directed to an integrated device constructed to permit digital as
well as alternate-site body fluid sampling and analysis, the device
comprising: a housing; at least one skin-penetration member; and a
member constructed for the application of circumferential pressure
to a digit of the user; wherein the member is movably or
retractably connected to the housing in a manner such that the
integrated monitoring and body fluid sampling device can perform
digital or alternate-site body fluid sampling and analysis.
[0037] According to another aspect, the present invention is
directed to an arrangement for body fluid sampling, the arrangement
comprising: a housing; at least one skin penetration member; and a
member constructed to apply circumferential or substantially
circumferential pressure to a digit placed therein; wherein the at
least one skin penetration member is constructed and arranged to
pierce a surface of the skin of the digit at a location proximate
to the member constructed to apply circumferential pressure.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0038] 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:
[0039] FIG. 1 is a partial perspective view of a device constructed
according to the present invention.
[0040] FIG. 2 is a partial cut away side view of the device of FIG.
1.
[0041] FIGS. 3A-3B are end views of a device constructed according
to an alternative embodiment of the present invention.
[0042] FIGS. 4A-4B are end views of a device constructed according
to a further alternative embodiment of the present invention.
[0043] FIGS. 5A-5B are end views of a device constructed according
to another alternative embodiment of the present invention.
[0044] FIGS. 6A-6B are end views of a device constructed according
to a further alternative embodiment of present invention.
[0045] FIGS. 7A-7B are end views construct according to yet another
alternative embodiment of the present invention.
[0046] FIGS. 8A-8B are side and perspective views, respectively, of
another embodiment of the device constructed according to the
principles of the present invention.
[0047] FIGS. 9A-9B are side and end views, respectively, of a
further embodiment of a device constructed according to the
principles of the present invention.
[0048] FIGS. 10A-10B are side and end views, respectively, of yet
another embodiment of a device constructed according to the
principles of the present invention.
[0049] FIGS. 11A-11B are perspective and top views, respectively,
of still another embodiment of the device constructed according to
the principles of the present invention.
[0050] FIG. 12 is a side view of a modified version of the device
of FIGS. 11A-11B.
[0051] FIG. 13 is a perspective view of an integrated device formed
according to one embodiment of the present invention.
[0052] FIG. 14 is a partial side view of the integrated device of
FIG. 13.
[0053] FIG. 15 is a perspective view of a component of the
integrated device of FIG. 13.
[0054] FIG. 16 is a partial perspective view of various components
of the integrated device of FIG. 13.
[0055] FIG. 17 is a side view illustrating various additional
components of the device of FIG. 13.
[0056] FIG. 18 is a perspective view of an integrated device formed
according to an alternative embodiment of the present
invention.
[0057] FIGS. 19A-19B are side views of an integrated device formed
according to a further alternative embodiment of the present
invention.
[0058] FIGS. 20A-20B are side views of an integrated device formed
according to yet another alternative embodiment of the present
invention.
[0059] FIGS. 21A-21D are side views of still another alternative
embodiment of an integrated device the present invention.
[0060] FIG. 22 is a side view of an additional embodiment of an
integrated device formed according to the present invention.
[0061] FIGS. 23A-23C are side, cross-sectional and partial side
views, respectively, of an integrated device formed according to an
additional alternative embodiment of the present invention.
DETAILED DESCRIPTION
[0062] According to a first aspect of the present invention, there
are provided arrangements and techniques for reliably expressing
body fluid from a digit (e.g., finger or toe). For example,
according to the present invention, arrangements and techniques are
provided which consistently and reliably express an amount of body
fluid from a digit that is sufficient to perform an analysis to
quantify the amount of an analyte (e.g., glucose) contained
therein.
[0063] One embodiment of an arrangement of the type described above
is illustrated in FIGS. 1-2. As illustrated therein, the
arrangement 10 may include a housing 12. The housing 12 may have
any suitable shape or configuration, and is not limited to the
shape and configuration illustrated. The housing can be constructed
of any suitable material. For example, the housing may be
constructed of a polymeric or metallic material. The arrangement 10
further includes a catalyst device 14. In certain embodiments, the
catalyst device 14 is a member for applying pressure to a digit D
disposed therein at a location which is proximate to an area of the
digit from which a sample of body fluid is to be expressed (i.e.,
sampling site). The catalyst device 14 may cause the area of the
digit from which the sample of body fluid is to be expressed to
become perfused with blood and/or body fluid. This effect on the
digit facilitates expression of body fluid. According to the
illustrated embodiment, the catalyst device 14 comprises an
inflatable cuff 16 and a mount 18 that attaches the cuff 16 to the
housing 12.
[0064] The arrangement 10 further comprises a footprint 20 which is
attached to the housing 12. According to the illustrated
embodiment, the digit D is placed on the footprint 20 at the
sampling site. The footprint 20 is annular in shape according to
the illustrated embodiment. However, the footprint is not limited
to this shape or configuration. Numerous shapes or configurations
may satisfy the function of providing a footprint around the site
from which body fluid is to be expressed. According to certain
embodiments, the footprint 20 is constructed from a material which
facilitates the formation of a seal between the digit D and the
footprint 20. For example, suitable materials for this purpose
include a relatively soft elastomeric material, such as a silicone
rubber.
[0065] As illustrated in FIG. 2, the arrangement 10 further
includes at least one skin penetration member 22. The at least one
skin penetration member 22 can take any suitable form. For example,
the at least one skin penetration member can comprise a solid
lancet or a hollow needle. The least one skin-penetration member
can be formed of any suitable material, such as metal, plastic,
glass, etc. Optionally, the at least one skin penetration member
can be mounted to a hub 24. In further alternative embodiments, the
hub 24 may contain a pad comprising a reagent that changes color
upon reaction with a target analyte, as known per se to those
skilled in the art. The arrangement 10 can comprise a plurality of
skin penetration members 22. According to certain embodiments, the
plurality of skin penetration members 22 can be provided in the
form of a replaceable cartridge, as will be described in greater
detail below. The at least one skin penetration member 22, and/or
the hub 24 are attached to an actuation element 26. The actuation
element 26 can take any suitable form. For example, the actuation
element 26 may comprise a mechanical, electrical or pneumatic
element. According to the illustrated embodiment, the actuation
element 26 is in the form of a mechanical spring, more
specifically, in the form of a torsional spring.
[0066] According to certain embodiments of the present invention,
the catalyst device 14 operates in an automatic or semi-automatic
manner. For example, a user may insert a digit D into the cuff 16
such that the tip region of the digit D is located on the footprint
20. When the user is ready to produce a sample of body fluid, the
button B is pressed. This initiates a programmed sequence of events
in the device including actuation of the catalyst device 14,
thereby applying pressure to the digit D at an area proximate the
tip region or sampling site for a predetermined period of time. The
skin-penetration member 22 can then be driven into the skin at the
tip region of the digit D. At a further predetermined time, the
catalyst device 14 is deactivated. This mode of operation can be
characterized as "semi-automatic" in that sequence of events must
be manually initiated by the user via pressing the button B.
[0067] According to one alternative, the mode of operation can be
fully automatic. For example, the user inserts a digit D into the
cuff 16 and places a tip region thereof on the footprint 20. The
arrangement 10 can be provided with one or more sensors that detect
and verify that the digit is properly located and ready for the
sampling procedure to begin. Once this state has been sensed, the
device automatically activates the catalyst 14 which is applied to
the digit D for a predetermined period of time. Subsequently, the
at least one skin penetration members 22 is driven into the skin of
the digit D at a tip region thereof. At a subsequent predetermined
time, the catalyst device 14 is deactivated.
[0068] The arrangement 10 can form at least part of a device which
functions only to sample body fluid. For example, the arrangement
10 can be used to express body fluid from the digit D in the form
of a drop of blood which pools on the surface of the skin of the
user. This drop of blood can then be transferred to another
separate device which then transports and/or analyzes the sample
for a target analyte. Alternatively, the arrangement 10 may express
a sample of body fluid from the digit D, and then transport the
sample to a location which can then be accessed for further
analysis by a separate device. For instance, the sample body fluid
can be transported to a reagent-containing pad, also contained
within the arrangement 10. The sample then reacts with the reagent
to produce a detectable spot or signal. The reagent pad can then be
analyzed by a separate meter using photochemical, electrochemical,
or other suitable techniques known per se to those skilled in the
art. The reagent pad can remain within the arrangement 10 during
the aforementioned analysis. Alternatively, the reagent pad can be
removed from the arrangement 10 and inserted into a separate
device, such as an electrochemical or photometric meter.
[0069] According to an alternative embodiment, the arrangement 10
forms at least part of an integrated meter. In other words, the
arrangement 10 includes additional components which transport the
sample, and/or analyze it for content of a target analyte
substance. Various examples of such integrated meter will be
described in further detail herein.
[0070] As alluded to above, the catalyst device 14 can assume many
different forms. Exemplary alternative embodiments of the catalyst
device 14 will now be described by reference to FIGS. 3A-12.
[0071] As illustrated in FIGS. 3A-3B, the catalyst device 14 may
comprise an inflatable member or bladder 28 which, when inflated,
exerts pressure circumferentially about the digit D. The bladder 28
is connected to a pump P by a supply line 30. The pump P feeds air
into the interior of the bladder 28 via the supply line 30 thereby
inflating the bladder, as illustrated in FIG. 3B. The supply line
30 may be vented thereby enabling the bladder 28 to be deflated
after body fluid has been sampled. Alternatively, the pump P may be
reversible, thereby enabling deflation of the bladder 28.
[0072] According to another alternative, the catalyst device 14 can
comprise an alternative inflatable bladder construction. For
example, as depicted in FIGS. 4A-4B, the catalyst device 14 can
comprise an inflatable bladder 32 which is connected to a
fluid-filled flexible chamber 34 via a feed line 36. The fluid may
be noncompressible. The fluid can be forced into the interior of
the inflatable bladder 32 by any suitable mechanism. According to
the illustrated embodiment, the flexible chamber 34 is compressed
by a movable piston 38, thereby forcing the fluid out of the
flexible chamber 34 through the feed line 36 and into the interior
of the inflatable bladder 32. The piston 38 can be driven by any
suitable mechanism or arrangement. For example, the piston 38 can
be driven by solenoid, motor, and/or cam arrangement. The specifics
of the driving mechanism for the piston 38 being well within the
capabilities of those ordinary skill in the art. As with the
previously described embodiment of the catalyst device, the
embodiment depicted in FIGS. 4A-4B is constructed to exert a
circumferential pressure about the digit D.
[0073] As illustrated in FIGS. 5A-5B, the catalyst device 14 can
comprise a user-controlled spring clip 40. The clip 40 can comprise
first and second arms 42,44 that are configured to substantially
surround the digit D. According to one alternative, the clip 40
further comprises first and second end portions 46,48 which are
graspable by the user. The clip 40 is biased by a spring 50 such
that it is closed in its normal state. The user grasps the end
portions 46 and 48 pressing them together to open the arms 42,44 of
the clip 40 and insert the digit D therein. Then, the user releases
the end portions 46,48 and the bias provided by the spring 50 acts
to close the arms 42,44 around the inserted digit D. The spring
clip 40 thus exerts a circumferential, or substantially
circumferential pressure about the digit D.
[0074] In the alternative construction illustrated in FIGS. 6A-6B,
the catalyst device 14 comprises a cable or strap 52 which is
attached at one end thereof to a motor M. The motor M is
constructed to wind the cable or strap 52 thereby drawing a certain
length of the cable or strap 52 about the wound end portion
thereof, thus constricting the cable or strap 52 about the digit D.
The motor M can be driven by any suitable mechanism, such as a
solenoid or spring-loaded mechanism. The specifics of the drive
mechanism and the motor M being well within the capabilities of
those ordinary skill in the art. Thus, according to this
arrangement, circumferential pressure is applied about the digit
D.
[0075] FIGS. 7A-7B illustrate yet another alternative construction
for the catalyst device 14. According to this alternative, a pusher
arm 54 brought into contact with the digit D by a pressing member
56 attached to one end thereof. The pressing member 56 can comprise
any suitable configuration. For example, the pressing member 56 can
be in the form of a compression spring, per the illustrated
embodiment. Alternatively, the pressing member 56 can be in the
form of the movable fluid or mechanical piston-type arrangement,
the specifics of which being well within the capabilities of those
ordinary skill in the art. As illustrated in FIG. 7B, the pusher
arm 54 is driven into the digit D by the pressing member 56, and in
cooperation with a relatively rigid digit housing member 58,
creates pressure about the digit D. This pressure is not totally
circumferential, but can be characterized as "substantially
circumferential."
[0076] The catalyst device 14 is embodied by a cinchable strap
arrangement, as illustrated in FIGS. 8A-8B. As illustrated therein,
a strap 60 forms a loop 61 through which a digit D is inserted. The
cinchable strap 60 is retained in its operative position with the
assistance of a strap housing 62. The strap 60 comprises a free end
64 which passes through an opening or slot 66. In order to cinch
the strap about the digit D, the free end 64 is drawn through the
slot 66 by a suitable mechanism. Suitable mechanisms include
manually pulling the free end 64, or mechanically drawing the free
end 64 by suitable arrangements such as a motor, cam, or
spring-loaded device of the type previously described herein. The
specifics of the drawing mechanism being well within the
capabilities of those ordinary skill in the art. The strap 60 is
preferably formed from a material which facilitates cleaning
thereof any event that body fluid comes into contact with the strap
60 during the sampling procedure. For example, the strap 60 can be
formed of a non-porous thermoplastic material to facilitate
cleaning. The cinching of the strap about the digit D acts to apply
circumferential or substantially circumferential pressure
thereto.
[0077] According to a further alternative embodiment, and as
illustrated in FIGS. 9A-9B, the catalyst device 14 can comprise an
open jaw 68 through which a digit D is inserted. The jaw 68
comprises an interior portion which is roughly shaped correspond to
the circumference of the digit D. The dimensions of the interior
portion of the jaw 68 are large enough to accommodate most digits
therein without significant interference. Disposed within the inner
portion of the jaw 68 is an inflatable bladder or pillow 70. The
interior of the inflatable pillow 70 is in fluid communication with
the pump P through a feed line 72. The pump P is operable to force
air into the interior of the inflatable pillow 70 via the feed line
72. The feed line 72 can be vented to permit deflation of the
inflatable pillow 70. Alternatively, the pump P can be reversible
thereby providing an alternative mechanism for deflating the pillow
70. Thus, once inflated, the digit D is forced with a certain
degree of pressure into opposing walls of the interior portion of
the jaw 68. Thus, according to this embodiment, substantially
circumferential pressure is applied to the digit D, thereby
facilitating the expression of body fluid therefrom.
[0078] A modified version of the previously-described embodiment as
depicted in FIGS. 10A-10B. According to this embodiment, the
catalyst device 14 is in the form of what can be described in
general as a closed jaw 74. In the illustrated embodiment, the
closed jaw 74 comprises a movable arm 76 which is connected to a
frame 78 via a spring-loaded hinge 80. The arm 76 can be swung open
to permit the introduction of the digit D therein. The hinge is
biased to normally close the movable arm 76. An inflatable pillow
82 is disposed on the movable arm 76, and is connected to a pump P
by a connection line 84. The connection line 84 can be vented,
thereby allowing the pillow 82 to be deflated. Alternatively, the
pump P can be reversible, thereby providing an alternative
mechanism by which the pillow 82 can be deflated. Once the pillow
82 is inflated, the digit D is forced into opposing surfaces in the
interior of the closed jaw 74 thereby creating the desired
pressure. The closed nature of the jaw 74 of this particular
embodiment can act to provide pressure around a greater degree of
the circumference of the digit D as compared to the previously
described embodiment.
[0079] Yet another possible catalyst device construction is
depicted in FIGS. 11A-12. According to this embodiment, the
catalyst device is in the form of a U-shaped channel 86 comprising
first and second arms 88,90. According to this embodiment, the user
places a digit D between the first and second arms 88 and 90, then
draws the digit D back in the direction of the arrows A until the
tip-region of the digit is properly located for sampling to occur
(e.g., disposed upon the footprint 20). According to preferred
aspects, the first and second arms 88, 90 are flexible, and the
distance 92 between the first and second arms 88, 90 is such that
there is a significant amount of interference between the digit D
and the first and second arms 88, 90 as the digit D is pulled back
through the U-shaped channel 86. This interference creates the
desired pressure upon the digit D at a location proximate to the
tip region thereof from which to sample body fluid is to be
expressed. According to a further modification of the above
described embodiment, instead of having the user move the digit D
manually through to U-shaped channel, the arrangement can comprise
a mechanism for moving the U-shaped channel told to do the digit D.
Such a construction as illustrated in FIG. 12. According to this
modification, the U-shaped channel is attached to a motor M via an
appropriate mechanical linkage 94. The motor M drives the linkage
94, and the attached U-shaped member 86, in the direction of arrow
A. Upon reversal of the motor, the linkage 94 and the attached
U-shaped member 86 is driven back in the opposite direction. Of
course, it should be understood that the driving mechanism is not
limited to the illustrated example, and can take on any suitable
form. For example, the driving mechanism can comprise a solenoid,
spring driven mechanism, or other system known to produce a linear
motion. The particulars of the driving mechanism being well within
the capabilities of those ordinary skill in the art. Just as the
previously described embodiment, the U-shaped member has first and
second arms 86,88 with a distance 92 between them which creates an
interference with the digit D when moved in the direction of arrow
A. The pressure created on the digit D according to these
configurations can be described as "substantially" circumferential
pressure.
[0080] According to a further aspect of the present invention, the
above-described catalyst devices (e.g., 14), as previously
described herein, can form at least part of an integrated device.
As previously noted, as used herein, the term "integrated device"
or "integrated meter" means a device or meter that includes all
components necessary to perform sampling of the body fluid,
transport of the body fluid, quantification of an analyte, and
display of the amount of analyte contained in the sample body
fluid. Thus, according to the principles of the present invention,
an integrated device or meter can comprise one or more, or any
combination, of the features previously described herein. According
to further aspects of the present invention, and integrated meter
or device can comprise additional components and/or features, which
are described as follows.
[0081] One such integrated meter is illustrated in detail in FIGS.
13-17. As illustrated therein, the integrated meter 100 generally
comprises a housing 112 and a catalyst device 114. The catalyst
device 114 may take any suitable form. For example, as illustrated
in FIG. 13, the catalyst device 114 may comprise a cuff 116
attached to the housing 112 via a mount 118. Alternatively, the
catalyst device 114 can comprise any of the previously described
alternative catalyst device configurations. The integrated meter
100 may further comprise a footprint 120 of the type previously
described. A door 123 can be provided on the housing 112. The door
123 is connected via a hinge 125 to the housing 112. As described
in further detail below, the door 123 can be opened to reveal a
cartridge containing a plurality of skin-piercing elements. In the
illustrated embodiment, the integrated meter 100 further includes a
display 127 for communicating the results of the analysis on the
sample body fluid for the presence and/or concentration of an
analyte contained therein. The integrated meter 100 may further
include one or more buttons 129 which can be pressed by the user to
engage various functions and interfaces of the integrated meter
100.
[0082] FIG. 14 is an illustration of the integrated meter 100 with
the door 123 opened to reveal further details of the interior
components of the integrated meter 100. As illustrated therein, the
housing 112 contains a cartridge 131 therein. In the illustrated
embodiment, the cartridge 131 is circular and contains a plurality
of skin-piercing elements as further described herein. The
cartridge 131 is mounted about a hub 133 and is rotatable. Thus,
upon sampling a skin-piercing element is driven through an opening
in the housing in registry with the footprint 120 and pierces the
skin of the user. Once the test has been completed, the cartridge
131 can be rotated such that an unused skin-piercing element now
comes into registry with the opening in the housing and the
corresponding opening in the footprint 120 in preparation for the
next sampling event. It should be understood that the present
invention is not limited to the illustrated circular cartridge
having the particular configuration depicted in the drawing
figures. To the contrary, a number of alternative cartridge
configurations are possible, such as a slidable linear or polygonal
configuration (not shown). Also illustrated in FIG. 14 is the
presence of a light source 139 disposed on the back of the door
123. The light source 139 can take any suitable form, such as a
light emitting diode. It should be understood that alternative
light sources may also be utilized. The function of the light
source 139 will be described in further detail below.
[0083] Further details of the optical assembly 135, the light
source 139, and the replaceable cartridge 131 are illustrated in
FIGS. 15-16. As illustrated therein, the replaceable cartridge 131
generally may comprise a plurality of compartments defining a
plurality of body fluid sampling and analysis sites 132. Contained
in each sampling and analysis site 132 is a skin penetration member
122. Each skin penetration member 122 can take any suitable form.
According to the illustrated embodiment, each skin penetration
member 122 is in the form of a hollow needle. It should be
understood that alternative skin penetration members may also be
utilized consistent with the principles of the present invention
(e.g., solid lancets, etc.) each skin-penetration member can be
attached to a needle hub 124. Each needle hub 124 is, in turn,
attached to an actuation element 126. It should be understood that
a number of different actuation elements may be utilized according
to the principles of the present invention. The actuation elements
can be mechanical, electrical, pneumatic, etc. According to the
illustrated embodiment, the actuation element 126 is in the form of
a torsional spring. Upon activation, the torsional spring drives
the needle hub 124 and the attached skin penetration member 122
into the skin of the user disposed on the footprint 120. According
to certain embodiments, each sampling/analysis site 132 further
contains a signaling mechanism which produces a detectable signal
when contacted with a target analyte contained in a sample of body
fluid expressed from the skin of a digit D. A number of suitable
mechanisms are envisioned. The mechanisms may be based on
conventional technologies such as photometric or electrochemical
analysis. According to the illustrated embodiment, each needle hub
124 contains a reagent pad 129 which generally comprises an
absorbent material containing a chemical reagent which, upon
reaction with a target analyte, produces a chemical reaction that
results in a detectable signal. The reagent pad 129 is in fluid
communication with the inner bore of the skin piercing element 122.
As noted above, the signal can be detected optically,
electrochemically, or by other suitable means. According to one
embodiment, the reagent pad 129, upon reaction with the target
analyte, produces a spot which is optically detected by the optical
assembly 135 in a manner known to those skilled in the art. The
spot produced by the above-mentioned reaction can be observed
optically through a window 143 formed along the interior region of
the illustrated cartridge 131 by the optical assembly 135. In this
regard, light emitted from the light source 139 is incident upon
the reagent pad 129, and reflects off the surface thereof. Upon
formation of a reaction spot on the surface of the reagent pad 129,
the amount of light reflected off the reaction spot differs from
the light reflected off of other portions of the reagent pad 129
containing no such reaction spot. This reflected light is picked up
by the optical assembly, first through the lens 137 (FIG. 14), and
eventually is incident upon an optical detector element 142 (FIG.
16).
[0084] The optical detector element 142 generally comprises one or
more detector elements. According to one alternative construction,
the detector element 142 comprises a plurality of detector elements
formed in an array. The array can take any suitable configuration,
and can be a linear array according to one nonlimiting example. The
detector elements can comprise any suitable construction. For
example, the detector elements 142 can comprise a photo diode, CCD,
or CMOS based detector element. The signals transmitted to the
detector element 142 are passed on to suitable electronics
contained within the housing 112 (see, e.g., FIG. 17) via suitable
electrical connectors, such as flexible ribbons 141. The specifics
of the electronics and signal interpretation being familiar to
those of ordinary skill in the art. While not necessary to enable
practice of the presently claimed invention, further details
concerning the construction, function and arrangement of the
analysis sites 132, and components contained therein, can be
gleaned from the disclosure contained in U.S. patent application
Ser. No. 60/721,966, entitled DEVICE FOR FLUID ANALYSIS WITH SAMPLE
EXTRACTION AND TRANSPORT, the entire content of which is
incorporated herein by reference. Similarly, while not necessary to
enable practice of the presently claimed invention, further details
concerning the structure, function, and arrangement of the optical
assembly 135, and the components contained therein, can be gleaned
from the disclosure contained in U.S. patent application Ser. No.
11/239,122, entitled ANALYTE DETECTION DEVICES AND METHODS WITH
HEMATOCRIT/VOLUME CORRECTION AND FEEDBACK CONTROL, the entire
content of which is incorporated herein by reference.
[0085] Additional components of an integrated meter 100 are
illustrated in FIG. 17. The view depicted in FIG. 17 is that of an
integrated meter 100 with the back panel removed to reveal the
above-referenced additional components. For example, as illustrated
in FIG. 17, the integrated meter 100 may further include a
plurality of rollers 147 which cooperate with the cartridge 131 and
a motor drive 149 thereby enabling the rotation of the cartridge
131 about the hub 133, and indexing of the analysis sites 132 with
the footprint 120. The integrated meter 100 may also include a
pressure pump 151 which, according to certain embodiments,
comprises a pump capable of producing both positive and negative
pressures. Thus, for example, the pump 151 can create a positive
pressure within the cuff 116, as previously discussed.
Alternatively, or in addition, the pump 151 can create a negative
or vacuum pressure at the surface of the skin located over the
footprint 120. The integrated meter 100 may further include
appropriate electronics, as embodied in the circuit board 153 of
the illustrated embodiment. Preferably, the circuit board contains
conventional electronic components capable of controlling the
various functions of the integrated meter 100 in the desired
manner. The particulars of the circuit board 153, and electronic
components disposed thereon, being well-known to those of ordinary
skill in the art. Finally, the integrated meter 100 may further
comprise a suitable power supply 155, such as the illustrated
batteries.
[0086] The embodiment of the integrated meter 100 illustrated in
FIGS. 13-17 includes a catalyst device 114 in the form of the cuff
116 which is fixedly mounted to the housing 112 via mount 118. Due
to this construction, the integrated meter 100 is suitable for
digital testing (e.g., finger testing). A modified form of the
integrated meter 100 is illustrated in FIG. 18. As illustrated
therein, the integrated meter 200 comprises a housing 212 which a
shaped and contoured to conform to the grip of a user. In this
regard, the housing 212 includes a plurality of recesses 213 which
are shaped in contoured to be grasped by the fingers, as well as a
contoured rear surface 215 which is shaped to conform to surfaces
of the palm and thumb of the user. The integrated meter 200
comprises a catalyst device 214 comprising, at least in part,
passageway sized and configured to permit the insertion of a digit
D therein. The catalyst device 214 can have a construction of any
of the types of catalyst device as previously described herein.
According to the embodiment that is illustrated in FIG. 18, the
catalyst device 214 comprises an inflatable bladder or cuff 216.
The cuff 216 is structured and operates in the same manner
previously described herein. The integrated meter 200 further
comprises a suitable display 227 which communicates the results of
the analysis to the user. The integrated meter 200 further contains
at least one skin piercing element 222. Optionally, a plurality of
skin piercing elements 222 are contained within the housing 212.
According to certain embodiments, a plurality of skin piercing
elements 222 are provided in the form of the replaceable cartridge
231 having the same construction as the previously described
cartridge. As previously described herein, the catalyst device 214
has a mode of operation which can be characterized as automatic, or
semiautomatic. For example, the catalyst device 214 can be
activated manually by the user by pressing a button B, which
initiates the catalyst as well as further operation of the device,
as previously described herein. Alternatively, one or more sensors
are provided in the integrated meter 200 that function to determine
when a digit D is properly positioned and ready for sampling to
begin. Upon detection of this state, the catalyst as well as
further operations of the device are automatically initiated. The
integrated meter 200 may also have any one or combination of
features described as being associated with integrated meter
100.
[0087] The previously described embodiments illustrated in FIGS.
13-18 are configured for digital body fluid sampling and analysis.
According to further aspects of the present invention, modified
devices and techniques are provided which permit both digital body
fluid sampling and analysis as well as alternate-site body fluid
sampling and analysis, which may be performed at the election of
the user. In the description that follows, it should be understood
that the integrated meters described herein may have any of the
features and/or modes of operation as that of the previously
described embodiments.
[0088] A first illustrative embodiment of an integrated meter 300
which can perform both digital and alternate site body fluid
sampling and analysis is illustrated in FIGS. 19A-19B. According to
this embodiment, the integrated meter 300 generally comprises a
housing 312, a catalyst device 314 in the form of an inflatable
bladder or cuff 316. The cuff 316 is attached to the housing 312 in
a movable manner via a hinge 318. A footprint 320 is provided on
the exterior of the housing 312 which is adapted to receive a digit
thereon prior to commencement of the sampling and analysis
procedure. The integrated meter 300 may further comprise a
disposable cartridge 331, as well as a pump 351 having both
positive and negative pressure feed lines 330,332, respectively.
When it is desired to use the device for digital body fluid
sampling and analysis, the cuff 316 is folded upwardly to the
position illustrated in FIG. 19A whereby a digit can be inserted
there through and placed over the footprint 320 in a manner
previously described herein. Alternatively, at the election of the
user, the integrated meter 300 can be used for alternate site body
fluid sampling and analysis. As illustrated in FIG. 19B, the cuff
316 can be folded back and received within a recess 334 formed in
the housing 312 of the integrated meter 300. By repositioning the
cuff 316 in this manner, the meter 300 can be grasped and applied
to an alternate site by pressing the footprint 320 directly to the
skin of the user at the desired location for alternate site body
fluid sampling and analysis.
[0089] According to an alternative embodiment, an integrated meter
400 can be constructed as illustrated in FIGS. 20A-20B. The
integrated meter 400 generally includes a housing 412, and a
catalyst device 414, which may be in the form of an inflatable
bladder or cuff 416, a display 427 and a disposable cartridge 431,
all constructed as previously described herein. The cuff 416 is
connected to a frame 417 via a pivotable hinge or connector 419.
The footprint 420 may be connected to the frame 417, instead of
directly connected to the housing 412. The frame 417 is connected
to the housing 412 via a second pivotable connection 419. This the
second pivotable connection 419 allows the frame 417, and the cuff
416 attached thereto, to be rotated in the manner indicated at
arrow R. This pivotable connection 419 allows the cuff 416 to be
repositioned on the opposite side of the device, as indicated by
the broken lines appearing in FIG. 20A, thereby facilitating either
right-handed or left-handed testing by the user. The cuff 416 is
positioned as illustrated in FIG. 20A when it is desired to use the
device for digital body fluid sampling and analysis. When it is
desired to use the integrated meter 400 for alternate site body
fluid stamping and analysis, the cuff 416 can be folded back and
received within a recess 434 formed in the frame 427, as
illustrated in FIG. 20B. Optionally, the integrated meter 400 and
make include a feature which senses that the device is being used
for alternate site testing (e.g., sensors that detect when the cuff
46 has been folded back and received within a recess 434), and then
inverts the output on the display 417 so as to facilitate reading
the results of the analysis when the integrated meter is oriented
in a manner depicted in FIG. 20B.
[0090] FIGS. 21A-21D illustrate a further alternative embodiment
constructed according to the present invention. As illustrated
therein, the integrated device 500 is composed of at least two
separate components, a main component (FIG. 21A) and one or more
attachments (FIGS. 21B, 21C). As illustrated, the integrated meter
500 generally comprises a housing 512, a display 527, one or more
buttons 529, and a disposable cartridge 531, all constructed as
previously described herein. The integrated meter 500 further
comprises a pressure pump 551 which is connected to a positive feed
line 530, as well as a negative pressure feed line 532. The
positive pressure feed line 530 terminates in a female coupling
541. Similarly, the negative pressure feed line 532 terminates in a
female coupling 542. The couplings 541 and 542 can be structured
such that they are normally sealed in a closed matter until a
corresponding male member is inserted therein, thereby opening the
normally closed end and enabling fluid communication with the pump
551.
[0091] A first attachment 560 (FIG. 21B) is constructed to permit
digital body fluid sampling and analysis. The first attachment 560
comprises a plurality of pressure cuffs 516,516' fixedly mounted
thereto. This construction facilitates either right or left-handed
testing. The attachment 560 further comprises a footprint 520
constructed as previously described herein. A male connector 562 is
also provided which provides for fluid communication with the
interior of the cuffs 516,516'. The male connector 562 is
configured for insertion into corresponding female connector 541
present in the main component of the arrangement. Thus, by this
construction, positive pressure can be fed from the pump and
introduced into the interior of one or more of the inflatable cuffs
516,516'. In addition, or optionally, a plurality of electrical
contacts 564 may also be provided on the attachment 560. These
electrical contacts are configured to mate with corresponding
electrical contacts 547,549 disposed on the main unit (FIG. 21A).
By virtue of the nature of the electrical contacts 564, a signal is
sent to the electronics contained in the integrated meter 500 that
indicate that a digital sampling and analysis module is connected
thereto. Based on the signal, various controls and signals can then
be generated which tailor the functionality of the integrated meter
500 specifically for digital body fluid sampling and analysis. For
example, a solenoid or similar device can be used to open and close
valves present in one or more of the feed lines 530, 532, thereby
selectively applying positive pressure to the attachment, and more
specifically, to the interior of the cuffs 516,516' connected
thereto.
[0092] As illustrated in FIG. 21C, a second attachment 570 can be
provided which is constructed for alternate site body fluid
sampling and analysis. The second attachment 570 generally
comprises a footprint 520 disposed on the bottom surface thereof.
The second attachment 570 further comprises a male connector 572
which is configured for mating with the corresponding female
connector 542 present in the main unit (FIG. 21A), thereby enabling
pressure communication with the pump 551. More specifically, the
connection between a male coupling 572 and a female coupling 542
enables a vacuum to be applied in the vicinity of the footprint 520
when placed against the skin of the user, thereby serving to act as
a catalyst for the expression of body fluid at the sampling site.
In addition, or optionally, the attachment 570 also includes one or
more electrical contacts 574 which are constructed and function in
a manner similar to the electrical contacts 564 described in
connection with the first attachment 560. FIG. 21D illustrates an
integrated meter 500 having the second attachment 570 attached
thereto, thereby rendering the device suitable for alternate site
body fluid sampling and analysis.
[0093] According to a further alternative embodiment, an integrated
meter 600 can be constructed which is capable of both digital body
fluid sampling and analysis, as well as alternate site body fluid
sampling and analysis, without the use of attachments. Such a
construction as illustrated in FIG. 22. As illustrated therein, the
integrated meter 600 generally comprises a housing 612, and one or
more cuffs 616,616' securely attached thereto. This construction
facilitates digital body fluid sampling and analysis from either
the right or left hand of the user. The integrated meter 600 may
also include a display 627 and one or more buttons 629, as well as
any of the other previously described features or alternative
constructions set forth previously herein. The integrated meter 600
further includes a first of footprint 620 which is provided for
digital body fluid sampling and analysis. The integrated meter 600
further includes at least one additional footprint 620' which is
located at a position on the integrated meter 600 which allows easy
access thereto for positioning the meter 600 and sampling body
fluid at an alternate site. It should be understood that the
positioning of the footprints 620,620' is not limited to the
arrangement depicted in the illustrated embodiment. The footprint
620 and/or footprint 620' can be disposed on any suitable face, at
any suitable location, on the integrated meter 600 so long as the
functionality of providing for both digital and alternate site body
fluid sampling analysis can be provided.
[0094] An integrated meter capable of both digital and alternate
site body fluid sampling and analysis constructed according to a
further alternative embodiment of the present invention is
illustrated in FIGS. 23A-23C. As illustrated therein, the
integrated meter 700 generally comprises a housing 712, a display
717, a footprint 720, one or more buttons 729, and a catalyst
device 714 in the form of a retractable cuff 716. The cuff 716, as
with the previously described embodiments, may be formed in any
suitable manner and may take any of the alternative constructions
described previously. In addition, the integrated meter 700
comprise any one or more, or combinations of features previously
described its association with the other embodiments. Again, as
with the previously described embodiments, in the interest of
conciseness, an exhaustive listing of the optional features
associated with this embodiment has been omitted. The cuff 716 is
tethered to the integrated meter 700 via a pressure delivery
tube/cable assembly 730. As illustrated in FIG. 23B, the pressure
delivery tube/cable assembly 730 generally comprises a hollow
tubular member 731 which can deliver pressurized air to the cuff
716, as well as a concentrically located cable 732, which adds
strength to the assembly thereby enabling retraction and removal of
the cuff 716. It should be understood that the pressure to delivery
tube/cable assembly 730 is not limited to the illustrated
embodiment, but can take on further alternative constructions so
long as the desired functionality is maintained. When pulled out
into the position illustrated in FIG. 23A, a digit can be inserted
through the cuff 716 and placed over the footprint 720 in a manner
previously described herein, thus enabling digital body fluid
sampling and analysis. When the user desires to use the integrated
meter 700 for alternate site body fluid sampling and analysis, the
cuff 716 can be retracted via a tensioning device 736 having a
conventional construction. Upon retraction, the cuff 716 is
received within a similarly shaped recess 742 which is formed in a
housing 712. As illustrated in FIG. 23C, the majority of the cuff
716 is received within the recess 742, however, a small portion
remains outside the recess such that it can be easily grasped by
the user and withdrawn for use in digital body fluid sampling and
analysis.
[0095] An exemplary body fluid sampling and analysis methodology or
technique, which may be utilized in conjunction with any of the
above-mentioned catalyst devices or integrated meters, but is not
necessarily limited thereto, is described as follows.
[0096] 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 is 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 an 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
HEMATOCRIT/VOLUME 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.
[0097] 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, 6, unless
the term "means" is explicitly used.
[0098] 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.
* * * * *