U.S. patent application number 13/116061 was filed with the patent office on 2011-11-17 for hand-held device for measuring an analyte concentration in a sample of a body liquid.
Invention is credited to Gertrud Albrecht, Ulrich Porsch, Bernd Steiger, Uwe Wittmann.
Application Number | 20110281342 13/116061 |
Document ID | / |
Family ID | 40566110 |
Filed Date | 2011-11-17 |
United States Patent
Application |
20110281342 |
Kind Code |
A1 |
Porsch; Ulrich ; et
al. |
November 17, 2011 |
HAND-HELD DEVICE FOR MEASURING AN ANALYTE CONCENTRATION IN A SAMPLE
OF A BODY LIQUID
Abstract
A hand-held device for measuring an analyte concentration in a
sample of a body liquid includes a display means for displaying
measured values; a measured-value storage for storing measured
values; a measuring unit for generating measured values through
measurements of the analyte concentration; a clock; a control unit
for generating measured value datasets, each containing a measured
value supplied by the measuring unit as well as the date and hour
of the measurement by which the measured value was obtained, and
for writing them into the measured-value storage; and operating
elements that can be actuated by the user to set the clock, in
which case the control unit will generate a time-correction dataset
indicating the amount and direction of the setting effected. The
control unit writes time-correction datasets into the
measured-value storage so that a chronologically ordered sequence
is generated containing time-correction datasets and measured value
datasets.
Inventors: |
Porsch; Ulrich; (Weinheim,
DE) ; Steiger; Bernd; (Roemerberg, DE) ;
Albrecht; Gertrud; (Mannheim, DE) ; Wittmann;
Uwe; (Lampertheim, DE) |
Family ID: |
40566110 |
Appl. No.: |
13/116061 |
Filed: |
May 26, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/EP2009/008048 |
Nov 12, 2009 |
|
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13116061 |
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Current U.S.
Class: |
435/287.1 |
Current CPC
Class: |
A61B 5/14532 20130101;
G16B 40/00 20190201; G01N 33/48764 20130101; G16H 40/40
20180101 |
Class at
Publication: |
435/287.1 |
International
Class: |
C12M 1/34 20060101
C12M001/34 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 2, 2008 |
EP |
08020879.6 |
Claims
1. Hand-held device for measuring an analyte concentration in a
sample of a body liquid comprising: a display means for displaying
measured values; a measured-value storage for storing measured
values; a measuring unit for generating measured values through
measurements of the analyte concentration in samples of a body
liquid; a clock for supplying the date and hour of the day; a
control unit for generating measured value datasets, each
containing a measured value supplied by the measuring unit as well
as the date and hour of the measurement by which the measured value
was obtained, and for writing them into the measured-value storage;
operating elements that can be actuated by the user to set the
clock, in which case the control unit will generate a
time-correction dataset indicating the amount and direction of the
setting effected, wherein the control unit writes time-correction
datasets into the measured-value storage so that a chronologically
ordered sequence is generated containing time-correction datasets
and measured value datasets.
2. The hand-held device as defined in claim 1, wherein the measured
value datasets and the time-correction datasets have the same
length.
3. The hand-held device as defined in claim 1, wherein the
time-correction datasets are identified as time-correction datasets
by a marking that begins, related to the beginning of the dataset,
in the same position in which a field containing the measured value
begins in a measured value dataset.
4. The hand-held device as defined in claim 3, wherein the marking
of a time-correction dataset has the same length as the field of a
measured value dataset that contains the measured value.
5. The hand-held device as defined in claim 3, wherein the marking
begins by a bit string that represents the character 9.
6. The hand-held device as defined in claim 3, wherein the marking
is positioned at the beginning of a time-correction dataset.
7. The hand-held device as defined in claim 1, wherein the measured
value datasets contain a time field that indicates the hour of the
day when the measurement was taken, the time-correction datasets
containing, at the place where the time field is found in the
measured value datasets, a time-correction field that indicates the
number of minutes by which the hour of the day was changed by a
clock setting operation.
8. The hand-held device as defined in claim 1, wherein the measured
value datasets contain a date field that indicates the date on
which the measurement was taken, the time-correction datasets
containing, at the place where the date field is found in the
measured value datasets, a date-correction field that indicates the
number of days by which the date was changed by a clock setting
operation.
9. The hand-held device as defined in claim 1, wherein the
time-correction dataset contains a flag field that indicates the
direction in which the setting was made.
10. The hand-held device as defined in claim 9, wherein a flag in
the flag field indicates the direction of the setting in minutes,
while a further flag indicates the direction of the setting in
another time unit.
11. The hand-held device as defined in claim 10, wherein the time
unit of the flag that indicates the direction of the setting is in
days.
12. The hand-held device as defined in claim 1, wherein the control
unit writes a special dataset into the storage when at the time the
clock is set no reference time is available that would be altered
by the setting operation and when, consequently, neither the amount
nor the direction of a setting can be indicated.
13. The handheld device as defined in claim 12, wherein a special
dataset can be distinguished from a time-correction dataset by a
marking.
14. The handheld device as defined in claim 13, wherein the marking
by which a special dataset can be distinguished from a
time-correction dataset is positioned in the flag field.
15. The hand-held device as defined in claim 1, wherein the device
is a glucometer.
16. The hand-held device as defined in claim 1, wherein the device
comprises a battery compartment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of International
Application No. PCT/EP2009/008048 filed Nov. 12, 2009, which claims
priority to EP Application No. 08020879.6 filed Dec. 2, 2008. Each
of the referenced applications is incorporated herein by reference
in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to a hand-held device for
measuring an analyte concentration in a sample of a body
liquid.
BACKGROUND
[0003] A hand-held device for measuring an analyte concentration
has been known from WO 2007/030457 A1 and is used for quantitative
analysis of body liquids, for example of urine, blood and
interstitial liquid, i.e. for measuring the concentration of
medically significant analytes such as lactate, cholesterol and,
especially, glucose.
[0004] Hand-held devices of that kind can be carried along by the
users and are needed, for example, by diabetics who are required to
measure their glucose concentration on a sample of blood and/or
interstitial liquid several times a day.
[0005] The measured values so obtained can be stored in a
measured-value storage of the hand-held device for being
transferred later to an external evaluation unit, for example a
physician's PC. By evaluating the measured values obtained over an
extended period of time it is possible to optimize the medical
treatment of chronic diseases such as diabetes. Modern hand-held
devices therefore comprise a clock so that when the measuring
results are evaluated later the development over time of the
analyte concentration can be examined in relation to a stored time
information.
[0006] The time-dependent relation between the different measured
values may be distorted when the setting of the clock is altered.
This can be avoided when the hand-held device is equipped with an
internal clock that cannot be set by the user, a system that has
been known from DE 197 33 445 A1. Given the fact that medically
relevant analyte concentrations normally are subject to variation
according to the rhythm of the day it is, however, desirable to
provide the clock of a hand-held device with a setting function so
as to allow the time of the day to be adjusted between summer time
and winter time or on travels between different time zones. In
order to ensure that the evaluation of measured values obtained
over an extended period of time will not be distorted, it is
necessary that such time adjustments be recorded.
[0007] WO 2007/030457 discloses a hand-held device where measured
values, as well as the date and hour of the measurement by which
the respective value was obtained, are combined to form
measured-value datasets which are continuously stored in a
measured-value storage. When the clock is set, the amount and
direction of the change is stored in a storage (buffer log)
provided for that purpose so that the respective information can be
taken into account in evaluating the measured values later.
SUMMARY
[0008] The present invention shows a way how a sequence of measured
values of a hand-held devise can be evaluated with little input and
without being falsified by alterations of the time setting that may
have been made.
[0009] The invention includes a hand-held device for measuring an
analyte concentration in a sample of a body liquid comprising: a
display means for displaying measured values; a measured-value
storage for storing measured values; a measuring unit for
generating measured values through measurements of the analyte
concentration in samples of a body liquid; a clock for supplying
the date and hour of the day; a control unit for generating
measured value datasets, each containing a measured value supplied
by the measuring unit as well as the date and hour of the
measurement by which the measured value was obtained, and for
writing them into the measured-value storage; operating elements
that can be actuated by the user to set the clock, in which case
the control unit will generate a time-correction dataset indicating
the amount and direction of the setting effected, wherein the
control unit writes time-correction datasets into the
measured-value storage so that a chronologically ordered sequence
is generated containing time-correction datasets and measured value
datasets.
[0010] Every time the clock is set, the hand-held device generates
a time-correction dataset that indicates the amount and direction
of the setting and is stored in the measured-value storage of the
hand-held device together with measured value datasets containing
each a measured value as well as the information on the date and
hour the dataset was generated. Accordingly, a chronological
sequence made up from the time-correction datasets and the
measured-value datasets is generated in the measured-value storage
of a hand-held device according to the invention. The
time-correction datasets and the measured-value dataset are
therefore sorted in the measured-value storage according to the
time of generation of the respective dataset. This provides several
advantages: [0011] A single storage suffices for a hand-held device
according to the invention. Thus it possible to save components and
related production costs. [0012] The clock of a hand-held device
according to the invention can be set almost as often as desired,
the number of time-correction datasets that can be stored between
measured-value datasets of a series of measured values being
limited only by the size of the measured-value storage. [0013] The
position of a time-correction dataset within a series of measured
value datasets defines unambiguously the measured-value dataset to
which the respective time-correction dataset relates. The exact
time, i.e. the date and hour, of a setting effected will not be
required later for evaluation and, accordingly, does not need to be
recorded or stored so that the time-correction datasets of a
hand-held device according to the invention can be given a very
simple structure. The storage position of the time-correction
dataset within the measured-value storage, together with the amount
and direction by which the clock was adjusted, are sufficient to
permit correct evaluation of a series of measured-value datasets.
[0014] Given the fact that time and time-correction information do
not have to be evaluated in the hand-held device, a hand-held
device according to the invention can be equipped with a very
simple and, therefore, cost-effective control unit. A series of
datasets in chronological order can be retrieved by an external
device from the measured-value storage of the hand-held device
without any difficulty via a hardware interface, and can be
evaluated at any time, all relevant information being contained in
the chronologically sorted sequence of datasets. [0015] The
evaluation can be restricted to any desired fraction of the
chronologically sorted sequence of measured-value datasets and
time-correction datasets. For, the time-dependent relation between
a desired number of successive measured value datasets is clearly
documented by time-correction datasets placed between them so that
any desired partial series of datasets can be correctly evaluated
without any additional information being needed. This facilitates
the use at a later time and the repeated evaluation of data, that
were obtained by a hand-held device according to the invention, by
an external device, for example a physician's PC. [0016] In the
event of a partial loss of data the remaining part of the data do
not become worthless as the evaluation can be limited to any
desired number of successive data set.
[0017] An advantageous further development provides that the
measured value datasets and the time-correction datasets have the
same length. This helps simplify the architecture and management of
the measured-value storage as all strings to be stored as datasets
in the measured-value storage have the same length.
[0018] Time-correction datasets and measured value datasets can be
distinguished for example by a special data field or a flag. In one
embodiment, the time-correction datasets are identified as such by
a marking that begins, related to the beginning of the dataset, in
the same position in which a field containing the measured value
begins in a measured value dataset. It is possible in this way to
give the datasets an advantageously short length as no additional
field is required for differentiation. This is so because the
marking envisaged by the invention may, for example, include a
string of characters or bits which, in a measured-value field of a
measured value dataset, would represent a value that would be
impossible physiologically. According to one embodiment, the
marking may include a character string that begins by the digit 9,
especially by 99.
[0019] Having the marking begin with a string representing the
digit 9 makes it possible, for example, to use the bit string 99 or
999 as a marking for a time-correction dataset in a data field
which, in a measured value dataset, would contain a measured value,
as corresponding concentration values will never be encountered in
practice.
[0020] It is further contemplated to give the markings of the
time-correction datasets the same length as the field of the
measured value datasets that contains the measured value. Even
though two digits 9, followed by any third digit, would be
sufficient in the described example as a marking for a
time-correction dataset, a greater number of characters or digits
would provide improved safety from writing or reading errors.
[0021] In addition, the marking identifying time-correction
datasets as such can be positioned at the beginning of a
time-correction dataset. This permits time-correction datasets to
be recognized as such.
BRIEF DESCRIPTION OF THE FIGURES
[0022] Further details and advantages of the invention will be
described hereafter with reference to one embodiment and to the
attached drawings. In the drawings:
[0023] FIG. 1 shows an embodiment of a hand-held device according
to the invention; and
[0024] FIG. 2 shows the data structure of the datasets generated by
the handheld device.
DETAILED DESCRIPTION
[0025] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended. Any such alterations and further modifications in the
illustrated devices, and such further applications of the
principles of the invention as illustrated herein are contemplated
as would normally occur to one skilled in the art to which the
invention relates.
[0026] FIG. 1 shows an embodiment of a medical hand-held device 1
for determination of an analyte concentration in a sample of a body
liquid of a person or an animal. In the illustrated embodiment, the
hand-held device 1 is a glucometer, intended to be used by
diabetics for determination of the glucose concentration in a
sample of blood or interstitial fluid.
[0027] For measuring, a sample of a body liquid is applied onto a
test field section of a carrier strip 2, and following a transport
step of the strip of suitable length the analyte concentration in
the sample so applied is measured in the device 1 by a measuring
unit, for example photometrically or electrochemically. There is
also the possibility to configure the hand-held device 1 in such a
way that a concentration can be determined with the aid of a
consumable material in the form of test strips. Test elements may
be stored for example in a magazine in the device, or can be
introduced together with the sample applied through an opening in
the housing. For loading fresh consumable material, for example a
cassette containing carrier strip 2, or for replacing batteries in
a battery compartment, a housing part 6 is made detachable.
[0028] Measuring results of the analyte concentration are displayed
by a display means 3, preferably a liquid crystal display, for
example a segment display. The measured values so obtained may be
displayed together with an indication of the date and hour, which
may be supplied by a clock integrated in the hand-held device 1. A
control unit of the hand-held device 1, such as a microprocessor,
generates from a measured value and from the date and hour of the
respective measurement a measured value dataset and writes it into
the measured-value storage which can be read out by an external
device via a hardware interface 5.
[0029] In the illustrated embodiment, the hardware interface is
designed for plug-in connection. There is, however, also the
possibility to design the hardware interface for wireless data
transmission.
[0030] Operating elements 4 that can be actuated by the user are
provided for operation of the device 1 and, especially, for setting
the clock. When the integrated clock is set, the control unit of
the device 1 generates a time-correction dataset, defining the
amount and direction of the setting, and writes that dataset into
the measured-value storage so that a chronologically ordered
sequence of time-correction datasets and measured value datasets is
generated in the measured-value storage. The chronological order
relates to the point in time at which the respective dataset was
generated and is derived automatically due to the fact that the
datasets are stored in the measured-value storage simply one after
the other.
[0031] FIG. 2 shows the structure of the datasets so stored in the
measured-value storage. The illustrated detail is a diagrammatic
representation of four successive datasets M1, T, M2 and M3,
representing a section of a sequence stored in a measured-value
storage. The datasets M1, M2 and M3 are measured value datasets,
the record T is a time-correction dataset. The dataset M1, M2, M3
and T all have the same length and contain four data fields A, B,
C, D.
[0032] The first data field A has a length of four characters and
contains, in the case of the measured value datasets M1, M2, M3, a
measured value of a glucose concentration, for example in mg/dl.
With respect to the time-correction dataset T the data field D
contains the entry 999 which identifies it as a time-correction
dataset.
[0033] The second data field B also has the length of four
characters and indicates, in the case of the measured value
datasets M1, M2, M3, the hour of the day at which the measurement
was taken, the first two characters identifying the hour, from 0 to
24, and the last two characters indicating the respective time in
minutes, from 0 to 59. In the case of the time-correction dataset
T, the data field B contains the amount by which the time was
altered.
[0034] In the illustrated embodiment, the data field D of the
time-correction dataset T contains the number of minutes by which
the time was adjusted so that in the case of a time-correction
dataset the data field B contains an entry between 0 and the
maximum number of minutes contained in 24 hours, i.e. 1140. In
principle, it is however also possible to enter in the respective
position of the data field of a time-correction dataset the
respective number of hours or minutes, in which case the first two
digits of the data field B would indicate the number of hours by
which the clock was adjusted, while the two last digits of the
dataset B would indicate the number of minutes by which the minute
value indicated by the clock was adjusted.
[0035] In the illustrated embodiment of the time-correction dataset
T the clock of the hand-held device 1 was adjusted by 2 hours so
that, correspondingly, the data field B shows the entry 0120 to
indicate that the clock was adjusted by 120 minutes.
[0036] In the case of a measured value dataset the third data field
C of the datasets indicates the date when the measured values were
obtained, the first two digits indicating the year, the next two
digits indicating the month, and the last two digits indicating the
day in the illustrated embodiment. In the case of a time-correction
dataset the last two digits may indicate the number of days by
which the clock was adjusted, while the two digits before these
last two digits indicate the number of months, and the first two
digits indicate the number of years by which the respective part of
the date was adjusted.
[0037] The fourth field D of the datasets of the embodiment
discussed above contains different flags that indicate if the
entries in data fields B and C of a time-correction dataset are
positive or negative, thereby indicating the direction in which the
clock setting was altered. For example, the character B in the
dataset T indicates as a flag that the clock was set back.
Preferably, the field D additionally contains a check bit or a
check digit to allow a dataset to be checked for possible writing
or reading errors. Additionally, the field D may contain an entry
indicating whether the measured value of the respective measured
value dataset is above or below a predefined threshold value.
[0038] The data field B of a measured value dataset is described as
a time field in a measured value dataset and as a time-correction
field in a time-correction dataset. Correspondingly, the data field
C is described as a date field in a measured value dataset and as a
date-correction field in a time-correction dataset.
[0039] When the clock is set it may happen that the amount by which
the clock was adjusted cannot be determined. That case may arise
for example when the device is started up for the first time or
after an extended power failure, for example when the battery is
replaced. In such a case, the control unit will write into the
storage a special dataset, preferably of the same length and
structure as the measured-value and the time-correction datasets.
Such a special dataset can be distinguished from a time-correction
dataset by a special marking that may be positioned in the flag
field D, for example.
[0040] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that all changes and modifications that come
within the spirit of the invention are desired to be protected.
LIST OF REFERENCE NUMERALS
[0041] 1 Hand-held device [0042] 2 Carrier strip [0043] 3 Display
means [0044] 4 Operating element [0045] 5 Hardware interface [0046]
M1, M2, M3 Measured value dataset [0047] T Time-correction dataset
[0048] A, B, C, D Data field
* * * * *