U.S. patent application number 16/596219 was filed with the patent office on 2020-02-06 for liquid sample measuring system and measuring device.
The applicant listed for this patent is PHC Holdings Corporation. Invention is credited to Masataka NADAOKA, Yoshimasa ODA, Teppei SHINNO, Noriyoshi TERASHIMA.
Application Number | 20200041436 16/596219 |
Document ID | / |
Family ID | 48696773 |
Filed Date | 2020-02-06 |
View All Diagrams
United States Patent
Application |
20200041436 |
Kind Code |
A1 |
TERASHIMA; Noriyoshi ; et
al. |
February 6, 2020 |
LIQUID SAMPLE MEASURING SYSTEM AND MEASURING DEVICE
Abstract
A liquid sample measuring system includes a measuring device
including a measuring section which measures biological information
from liquid sample of a living subject within a housing in which a
biosensor, on which the liquid sample of the biological body is
deposited, is detachably mounted and a movement measuring section
which measures movement information of the housing within the
housing, and an administrating device including a movement
determining section which determines whether or not a degree of the
movement of the housing is within an allowable range by analyzing
the movement information received from the measuring device.
Inventors: |
TERASHIMA; Noriyoshi;
(Kanagawa, JP) ; SHINNO; Teppei; (Ehime, JP)
; NADAOKA; Masataka; (Ehime, JP) ; ODA;
Yoshimasa; (Ehime, JP) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PHC Holdings Corporation |
Tokyo |
|
JP |
|
|
Family ID: |
48696773 |
Appl. No.: |
16/596219 |
Filed: |
October 8, 2019 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15728506 |
Oct 10, 2017 |
10473608 |
|
|
16596219 |
|
|
|
|
14367938 |
Jun 23, 2014 |
9816955 |
|
|
PCT/JP2012/008310 |
Dec 26, 2012 |
|
|
|
15728506 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 33/48792 20130101;
G01N 27/3273 20130101; G01N 27/3272 20130101; G01N 27/3274
20130101 |
International
Class: |
G01N 27/327 20060101
G01N027/327; G01N 33/487 20060101 G01N033/487 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 26, 2011 |
JP |
2011-283197 |
Claims
1-14. (canceled)
15. A liquid sample measuring device, comprising: a housing to
which a biosensor on which a liquid sample of a living subject is
deposited is detachably mounted; a measuring section configured to
measure biological information from the liquid sample of the living
subject, the measuring section disposed inside of the housing; a
movement measuring section configured to measure movement
information of the housing, the movement measuring section disposed
inside the housing; a recording section configured to record
identification information including at least one of identification
of a measurer, identification of a subject person, and
identification of the biosensor as measuring administration data;
an input section to which the identification information and the
movement instruction from the measurer are inputted; a display
section configured to display the measuring administration data and
information for the measurer; a control section configured to
calculate consumption of the biosensor by extracting the
identification of the biosensor from the measuring administration
data.
16. The liquid sample measuring device according to claim 15,
wherein: the measuring administration data includes at least one of
a time of mounting the biosensor, a time of the sample deposition,
a time of starting measuring and a time of ending measuring.
17. The liquid sample measuring device according to claim 16,
wherein: the measuring administration data includes at least one of
a glucose concentration and regarding information which the
measurer selects.
18. The liquid sample measuring device according to claim 15,
wherein: the display section displays the biosensor information
which is usable for the measurer form the consumption of the
biosensor.
19. The liquid sample measuring device according to claim 15,
wherein: the input section is at least one of a button, a barcode
reader, a RF-ID and a scanner.
20. The liquid sample measuring device according to claim 15,
further comprising: a movement determining section configured to
analyze the movement information measured with the movement
measuring section and determine whether a degree of movement of the
housing is within an allowable range.
Description
PRIORITY
[0001] This application is a continuation application of U.S.
application Ser. No. 14/367,938 filed on Jun. 23, 2014 which claims
priority to International Application PCT/JP2012/008310, with an
international filing date of Dec. 26, 2012 which claims priority to
Japanese Patent Application No. JP2011-283197 filed on Dec. 26,
2011. The entire disclosures of U.S. application Ser. No.
14/367,938, International Application PCT/JP2012/008310 and
Japanese Patent Application No. JP2011-283197 are hereby
incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention relates to a measuring device and a
liquid sample measuring system including the measuring device which
measures biological information from a liquid sample of living
subject.
BACKGROUND
[0003] There has been a hand-held type of a measuring device of
measuring liquid sample of a living subject. The measuring device
can easily perform measuring the liquid sample, which was
conventionally performed by a large clinical measuring device. For
example, a user can measure his/her liquid sample daily at home by
the measuring device. Also, a nurse can measure the liquid sample
of a patient by using the measuring device on the bedside of a room
or an examination room of a medical institution.
[0004] Because of introduction of various measuring technologies,
the hand-held type measuring device has provided lessening amount
of a sample which is needed for measuring and shortening time for
measuring, and thus is shaped to enhance convenience.
[0005] However, accuracy of the result of measuring with the
existing measuring device fluctuates due to various factors.
[0006] For example, in a case in which the measuring device is a
blood glucose measuring device which measures glucose concentration
in blood, there are factors for the fluctuation in the result of
measuring, as follows.
[0007] First, an interfering substance in the blood and a state of
the blood influence the result of measuring. For a blood glucose
monitor which is for measuring whole blood, a fact that a ratio of
blood cell in the blood which changes on the basis of a condition
of a subject person or a disease state influences the result of
measuring the glucose concentration is well known. Also, it is
known that there is a reagent among reagents used for measuring the
blood glucose which reacts with the maltose in the blood and shows
higher concentration than concentration of glucose as principally a
measuring object in a case in which the maltose is provided to the
blood by dialysis or infusion from dialysis fluid.
[0008] There are countermeasures in which a measuring method with
correcting by hematocrit value as a blood cell ratio in the blood
and a reagent which is less influenced by the maltose are employed,
in order to decrease the fluctuation in the result of measuring due
to the factors like this.
[0009] Second, fluctuation in a manufacturing process of the
biosensor influences the result of measurement. The biosensor
(blood glucose sensor) is used as being completely disposable for
measuring the blood glucose. Manufacturers manufacture blood
glucose sensors a lot every day in response to demands of measuring
the blood glucose being performed multiple times a day. For this
reason, the fluctuation in quality of the biosensor (blood glucose
sensor) happens due to changes in environment and materials in the
manufacturing process of the biosensor.
[0010] There are countermeasures in which materials or a process of
manufacturing to minimize the fluctuation in manufacturing the
biosensor, and switching measuring parameters by considering the
fluctuation are employed, in order to decrease the fluctuation in
the result of measuring due to the factors.
[0011] Third, a state of using a measuring device main body
influences the result of measuring. The hand-held type of the
measuring device is easily brought between user's home, outside,
and each room of a hospital. For this reason, constituent elements
such as electric parts and mechanical parts in the measuring device
main body are damaged due to physical impact from outside such as
dropping. Then, it is possible that the measuring device cannot
measure in a normal way.
[0012] There are countermeasures in which notifying, if necessary,
is employed by measuring a degree of the impact and determining
whether or not the degree of the impact is large enough to
influence accuracy of measuring the blood glucose (for example, see
Patent Literature 1: Japanese Patent Application Publication No.
2011-209246).
[0013] As mentioned above, effort has been made in suppressing the
fluctuation in the result of measuring by finding causes of the
fluctuation in the result of measuring due to the various
factors.
[0014] However, in the above mentioned effort or the like, the
countermeasure has not been made to reveal the influence to
decreasing the accuracy in measuring due to user's movement
(handling), when measuring the liquid sample is actually
performed.
[0015] In other words, there is a problem in the handling when the
user measures the liquid sample, and that causes the fluctuation in
the result of measuring. In this case, the measuring device shows a
wrong value as the result of measuring, or has an error for
movement of measuring. However, the above mentioned measuring
device has problems in not performing an appropriate countermeasure
by specifying problems of the handling.
[0016] Then, the description below has an objective in providing a
liquid sample measuring system and a measuring device for
performing the appropriate countermeasure by specifying the problem
of use's handling.
SUMMARY
[0017] A liquid sample measuring system which is described
hereinafter includes a measuring device including a measuring
section which measures biological information from liquid sample of
a living subject within a housing in which a biosensor, on which
the liquid sample of the biological body is deposited, is
detachably mounted and a movement measuring section which measures
movement information of the housing within the housing, and an
administrating device including a movement determining section
which determines whether or not a level of the movement of the
housing is within an allowable range by analyzing the movement
information received from the measuring device.
BRIEF DESCRIPTION OF DRAWINGS
[0018] FIG. 1 is a view showing an arrangement of a liquid sample
measuring system of a first embodiment;
[0019] FIG. 2 is a exploded diagrammatic view of a biosensor;
[0020] FIG. 3 is a block diagram of the measuring device of the
first embodiment;
[0021] FIG. 4 is a front view showing an example of the measuring
device including a movement measuring section;
[0022] FIG. 5 is a diagonal perspective view showing an example of
the measuring device including the movement measuring section;
[0023] FIG. 6 is a block diagram showing an arrangement of an
administrating device of the first embodiment;
[0024] FIG. 7 is a view showing changes a level of movement of the
measuring device;
[0025] FIG. 8 is view showing an arrangement of a liquid sample
measuring system including a plurality of the measuring
devices;
[0026] FIG. 9 is a view showing an arrangement of the liquid sample
measuring system including an information collection function;
[0027] FIG. 10 is a block diagram showing an arrangement of the
measuring device of a second embodiment;
[0028] FIG. 11 is a flowchart showing a procedure of the movement
of the measuring device including an instruction function to a
user;
[0029] FIG. 12 is a diagonal perspective view of an appearance of
the measuring device of a third embodiment; and
[0030] FIG. 13 is a block diagram showing the measuring device of
the third embodiment.
DETAILED DESCRIPTION
[0031] A liquid sample measuring system as embodiments of the
present invention is described in detail hereinafter with reference
to the figures.
First Embodiment
[0032] FIG. 1 is a view showing an entire arrangement of the liquid
sample measuring system of a first embodiment. As shown in FIG. 1,
the liquid sample measuring system includes a measuring device 1
and an administrating device 2. The measuring device 1 and the
administrating device 2 communicate by being connected each other
with a wired connection by a cable, or connected wirelessly by
radio wave or infrared ray. Alternatively, it is fine that there is
Internet or a network of an intranet between the measuring device 1
and the administrating device 2, and that measuring device 1 and a
network access point, and an administrating device 2 and the
network access point are connected with a wired or wireless
connection. Hereinafter, a communication line 3 is a collective
term for the wired and wireless connections, and connections via
networks.
[0033] The measuring device 1 is a hand-held type measuring device.
The measuring device 1 includes a device main body (housing) 4, a
display section 5, and an input section 6. On the device main body
4 of the measuring device 1, a biosensor 7 which is disposable is
mounted or dismounted.
[0034] The device main body 4 is formed in a compact shape which a
nurse or a patient as a user can hold with one hand.
[0035] The administrating device 2 includes a device main body 8, a
display section 9, and an input section 10. It is fine that all, or
any combination of, the device main body 8, the display section 9,
and the input section 10, are entirely unitarily formed. Also, it
is fine that the device main body 8, the display section 9, and the
input section 10 are disposed in a place in a state in which
entirely connected by a cable, or disposed remotely in a state via
a network.
[0036] For example, the administrating device 2 being an ordinary
personal computer is one example of the former. Also, an
arrangement in which the device main body 8 is a server device
disposed in a server room, the display section 9 is a monitor
disposed on a wall of a nurse station of a hospital, and the input
section 10 is a touch panel which enables inputting by touching on
the monitor in one example of the latter.
[0037] When the liquid sample measuring system is used, for
example, in a hospital, the measuring device 1 is carried by a
nurse to go around medical wards, and the administrating device 2
is disposed at a nurse station for use.
[0038] Next, the biosensor 7 which is disposable and is mounted to
the measuring device 1 is described with reference to FIG. 2. FIG.
2 is an exploded diagrammatic view of the biosensor 7 mounted to
the measuring device 1.
[0039] The biosensor 7 include an insulated substrate 11 made of
polyethylene terephthalate or the like (hereinafter simply
substrate 11). On a surface of the substrate 11, a conductive layer
is formed. The conductive layer is made of, for example, noble
metal such as gold and palladium, or made of a conductive material
such as carbon. The conductive layer is formed on the substrate 11
by a screen printing method or a sputtering vapor deposition
method. The conductive layer can be formed entirely on the
substrate 11 or at least partially on the substrate 11. Also, the
biosensor 7 includes an insulated substrate 12 on an upper surface
thereof. The substrate 12 includes an air opening 13 at a middle
part thereof. Between the substrate 11 and the substrate 12, a
spacer 14 including a notch part is sandwiched. The substrate 11,
the spacer 14, and the substrate 12 unitarily constitute the
biosensor 7.
[0040] On the substrate 11, a counter electrode 17, a measurement
electrode 18, and a detection electrode 19 are formed by slits
dividing the conductive layer. Each of the electrodes 17, 18, 19 is
formed at least on a part of the substrate 11. Also, it is fine
that each of the electrodes 17, 18, 19 is connected to the
measuring device 1 through lead wires in a state in which the
biosensor 7 is mounted to the device main body 4 of the measuring
device 1.
[0041] The spacer 14 is disposed so as to cover the counter
electrode 17, measurement electrode 18, and detection electrode 19
on the substrate 11. A sample supply route 15 is formed by a notch
part being rectangular and configured on a front edge and a center
of the spacer 14. Also, the liquid sample is deposited at a sample
spotting part 15a which is a tip the sample supply route 15. When
the liquid sample is deposited on the sample spotting part 15a, the
liquid sample is suctioned towards an air opening 13 of the
substrate 12 (in a direction of an arrow AR in FIG. 2) by capillary
action.
[0042] The reagent layer 16 has a size and a shape to cover the
counter electrode 17, measurement electrode 18, and the detection
electrode 19 which are exposed from the notch part of the spacer
14.
[0043] The reagent layer 16 includes an oxidation reduction enzyme
and an electron acceptor. The oxidation reduction enzyme and the
lector acceptor are dissolved and react with the liquid sample (in
the present embodiment, blood from a human body) which is suctioned
by the sample supply route 15. After the reaction, the measurement
device 1 electrochemically oxidizes the electron acceptor, which
has been reduced. The measuring device 1 measures the biological
information (in the present embodiment, the blood glucose
concentration in the blood) in the liquid sample on the basis of
the electric current obtained by the oxidation. This chain of the
reaction is read by electric current with the electrochemical
changes by the counter electrode 17, the measurement electrode 18,
and the detection electrode 19.
[0044] Also, an identifying part 20 is a member which identifies
differences in output characteristic depending on kinds and
production lot of the biosensor 7 by the device main body 4. A
combination of slit 21g and a slit 21h are configured at a part
corresponding to the identifying part 20 of the counter electrode
17 and the detection electrode 19. By this, the device main body 4
can identify the difference of the electrical output characteristic
of each biosensor 7.
[0045] The counter electrode 17, the measurement electrode 18, the
counter electrode 17, and detection electrode 19 are arranged in
the order from the sample spotting part 15a in the flow direction
of the liquid sample (arrow AR) on the substrate 11 of the
biosensor 7. The configuration of the counter electrode 17 and the
measurement electrode 18 can be switched
[0046] Also, there is a prescribed distance between the measurement
electrode 18 and the detection electrode 19 in the direction of the
liquid sample flowing. By this, the detection electrode 19 can
identify whether or not the liquid sample is surely and adequately
suctioned.
[0047] Next, constituent elements of the measuring device 1 are
described with reference to FIG. 3. FIG. 3 is a block diagram
showing the measuring device 1. As shown in FIG. 3, the measuring
device 1 includes a sensor wearing part 22, a measuring section 23,
a movement measuring section 24, a controller 25, a display section
5, an input section 6, a communication section 26, and a recording
section 27 in the device main body 4.
[0048] Further, in the sensor wearing part 22, a connector 22a and
a sensor wearing detection section 22b are disposed. The connector
22a is capable to connect electrically the counter electrode 17,
the measurement electrode 18, and the detection electrode 19 of the
biosensor 7, when the biosensor 7 is mounted. The sensor wearing
detection section 22b is to detect that the biosensor 7 is mounted
to the sensor wearing part 22.
[0049] The sensor wearing detection section 22b detects that the
biosensor 7 is equipped and transmits to the controller 25. The
means by the sensor wearing detection section 22b is, for example,
a mechanical electrical switch which is capable of detecting that
the biosensor 7 is equipped by the electrical switch being pushed
to conduct electrically while the object (biosensor 7) is equipped.
Other than that, the sensor wearing detection section 22b can be
any means, such as an optical sensor, as long as the existence of
the object at the sensor wearing part 22 can be detected.
[0050] Alternatively, the sensor wearing detection section 22b can
be an additional electrical circuit which is connected to the
connector 22a. In this case, when electrical conduction is detected
between the connector 22a and at least one of the counter electrode
17, the measurement electrode 18, and the detection electrode 19 at
the biosensor 7, the sensor wearing detection section 22b
determined that the biosensor 7 is mounted to the device main body
4.
[0051] The measuring section 23 receives an instruction from the
controller 25 and measures the biological information from the
liquid sample of the living subject which is deposited on the
biosensor 7. For example, when the blood is deposited on the
biosensor 7, electric voltage or current is applied to each of the
electrodes of the biosensor 7 via the connector 22a. The measuring
section 23 measures the glucose concentration in the blood from
value of the electric voltage or the current obtained in
corresponding to the application of the electric voltage.
[0052] The movement measuring section 24 receives an instruction
from the controller 25 and measures amount of movement of the
device main body 4. The movement measuring section 24 transmit
movement information as the amount of the movement to the
controller 25.
[0053] The controller 25 controls the measuring device 1 entirely.
Information is input from the sensor wearing detection section 22b,
the measuring section 23, the movement measuring section 24, and
the input section 6 to the controller 25. The controller 25
instructs the measuring section 23, the display section 5, the
communication section 26, and the recording section 27 on the basis
of the input information.
[0054] The display section 5 functions on the basis of an
instruction from the controller 25. The display section 5 displays
the glucose concentration as the biological information measured by
the measuring section 23. Also, the display section 5 displays
various information to the user.
[0055] The input section 6 is a device in which the movement
instruction or identification number is input from the user. Input
section 6 is, for example, a button disposed on the device main
body 4. Alternatively, the input section 6 may be an optical
reading device such as a barcode reader. Alternatively, the input
section 6 is an input by a wireless communication such as RF-ID, or
a voice recognition. The input section 6 in the present embodiment
is configured as a combination of these input devices. Also, the
information being input to the input section 6 is transmitted to
the controller 25.
[0056] The communication section 26 receives an instruction from
the controller 25 and receives from and transmits to other devices
such as a server or a personal computer via the communication line
3. For example, the communication section 26 transmits the
identification number which has been input to the input section 6
and the glucose concentration which has been measured by the
measuring section 23 to other devices. Also, the communication
section 26 receives a list of the identification number from other
devices.
[0057] The recording section 27 records, by receiving via the
controller 25, the result of measuring transmitted by the measuring
section 23, the movement information transmitted by the movement
measuring section 24, the information input by the input section 6,
and the information received by the communication section 26. The
recording and playing the data to the recording section 27 is
controlled by the controller 25.
[0058] When the user starts measuring the liquid sample by using
the aforementioned measuring device 1 and the biosensor 7,
inputting identification of the user (nurse) as a measurer,
identification of the patient as the subject person, and
identification of the biosensor 7 is performed by the input section
6. The input of the identifications may be performed by the user
pushing the button of the input section 6. Also, in a case where
the barcode reader is configured on the input section 6, it is fine
that inputting each of the identifications is input by reading the
barcode configured on each. Also, it if fine that each of the
identifications is obtained by a close distance wireless
communication from RF-ID tags configured on each. When inputting
the identifications is complete, preparation for measuring is
complete.
[0059] When the preparation for measuring is complete, the user
mounts the biosensor 7 next. The biosensor 7 is mounted to the
sensor wearing part 22, and the completion of equipping is detected
by the sensor wearing detection section 22b and transmitted to the
controller 25. The controller 25 keeps time at which when the
completion of mounting by the sensor wearing detection section 22
is detected is transmitted as time of mounting the sensor. Then,
the controller 25 instructs starting measuring the liquid sample to
the measuring section 23 of the controller 25.
[0060] The measuring section 23 to which the controller 25 has
instructed starting measuring starts applying electric voltage to
the counter electrode 17, the measurement electrode 18, and the
detection electrode 19 of the biosensor 7 via the connector 22a. At
this time, the blood has not been deposited on the sample spotting
part 15a of the biosensor 7.
[0061] When the blood is deposited on the sample spotting part 15a
by the user, the blood is suctioned towards the inside of the
sample supply route 15 by capillary action, and expands in a
direction towards the air opening 13. After that, the blood after
expanding reaches one, which is configured closest to the sample
spotting part 15a, of the counter electrode 17, the measurement
electrode 18, and the detection electrode 19. Responding to this,
the measuring section 23 detects the deposition of the blood by
changes in a response characteristic of the electric voltage
obtained via the connector 22a. The measuring section 23 transmits
the deposition of the blood to the controller 25. By this, the
controller 25 keeps the time at which when the blood is deposited
is detected as time of sample deposition.
[0062] The measuring section 23 starts measuring the glucose
concentration in the blood, when a set time from the time of the
sample deposition elapses, or when further changed occur in the
response characteristic of the electric voltage in the counter
electrode 17, the measurement electrode 18, and the detection
electrode 19. Then, the measuring section 23 transmits starting
measuring to the controller 25. Responding to this, the controller
25 keeps the time as time of starting measuring.
[0063] The time between the time of the sample deposition and the
time of starting measuring is needed for the blood, which is
deposited by the user, to expand adequately in the sample supply
route 15, to melt the reagent layer 16, and to react.
[0064] The measuring section 23 applies the electric voltage at
least one time between a plurality of the electrodes 17, 18 after
starting measuring. The measuring section 23 obtains response
value, at least one time, of the electric current accompanying
electrochemical changes during the application of the electric
voltage, and keeps as a current profile. Then, the measuring
section 23 specifies the glucose concentration by using the current
profile with Cottrell equation or other algorithm, and transmit the
glucose concentration to controller 25 as the result of measuring.
The controller 25 keeps time at which the glucose concentration
which has been measured by the measuring section 23 is transmitted
as time of ending measuring.
[0065] The controller 25 instructs the display section 5 to display
the glucose concentration which has been measured. At the same
time, the controller 25 displays candidates of information to be
associated with the glucose concentration, and enables the user to
select by using the input section 6. Here, the candidate of the
information is for seeing the situation of measuring when
confirming the result of measuring the glucose concentration, such
as information regarding meal including before meal or after meal.
The user can separately set what kinds of information are
selectable. Also, not only is the candidate of the information
selected, but it is also fine that the user can input a line of
texts by using the input section 6.
[0066] The controller 25 records in the recording section 27 the
information regarding measuring as a batch of measuring
administration data, after the user completes inputting. In the
measuring administration data include the identification of the
measurer, the identification of the subject person, and the
identification of the biosensor 7. Also, the measuring
administration data includes time of mounting the sensor, the time
of the sample deposition, time of starting measuring, and time of
ending measuring. Further, the measuring administration data
includes the glucose concentration, regarding information which the
user selects, and the information of the movement output by the
movement measuring section 24.
[0067] Also, the controller 25 monitors the glucose concentration
which is measured. The controller 25 adds an abnormal value flag
showing that matter to the measuring administration data, when the
glucose concentration being measured is an abnormal value which
cannot be normal obtained, or when the glucose concentration is a
value outside a range that the user sets. The controller 25
notifies the user by displaying the detection of the abnormal value
by the display section 5, when the abnormal value flag is
added.
[0068] Next, the movement measuring section 24 is described. The
movement measuring section 24 is realized by, for example, a
three-dimensional acceleration sensor disposed in the device main
body 4. The number of the acceleration sensor can be one or plural.
Also, a gyro sensor can be used instead of the acceleration sensor,
or any sensor, as long as changes in posture and moving distance
(amount of moving) of the device main body 4 in the direction of
the gravity are detected.
[0069] FIG. 4 shows an example in which an acceleration sensor is
disposed as the movement measuring section 24 in the device main
body 4. The acceleration sensor is disposed at an end opposite to
an end in a longitudinal direction to which the biosensor 7 is
mounted. Also, the acceleration sensor is disposed at a place off
from a width-direction center line 4A and a longitudinal-direction
center line 4B of the device main body 4. Here, the longitudinal
direction of the device main body 4 is a direction D in which the
biosensor 7 is mounted to the device main body 4. Also, the place
at which the acceleration sensor is disposed is off from a
barycenter of weight of the device main body 4.
[0070] The posture and the movement of the biosensor 7 are detected
accurately by the disposition of the acceleration sensor. Because
the sample which is deposited on the biosensor 7 is liquid, a
position and a direction of expanding of the liquid change due to
the posture and the movement of the biosensor 7. There are cases
where the direction and the position of expanding affect the result
of measuring the glucose concentration. Because of this, the
acceleration sensor is disposed at the place being effectual to
monitor the position and the direction of expanding of the liquid,
namely the place being off from the width-direction center line 4A
and the longitudinal-direction center line 4B of the device main
body 4.
[0071] FIG. 5 shows a three dimensional axes being overlapped on a
pattern view of the measuring device 1. Against the device main
body 4, a longitudinal direction is X axis 4X, a short direction is
Y axis 4Y, and a height direction is Z axis 4Z. An ordinary sensor
which detects a degree of changes in the movement (amount of
moving) per unit time for each of the three dimensional axes is
used for the acceleration sensor configured as the movement
measuring section 24.
[0072] It is fine as long as the movement measuring section 24 can
detects the degree of the changes in the movement (amount of
moving) per unit time for each of the three dimensional axes. Also,
kinds of sensor are not limited to the acceleration sensor.
[0073] The movement measuring section 24 transmits to the
controller 25 the degree of the changes in the movement (amount of
moving) per unit time detected for each of the three dimensional
axes as movement information while the controller 25 instructs.
Numerical expression of the degree of the changes in the movement
can be absolute number or relative value. Also, it is fine as long
as the movement information includes necessary and sufficient
information to replicate the movement of the device main body 4 on
the basis of the movement information. Also, an interval for
transmitting the movement information, namely a sampling interval,
is chosen to be an appropriate interval in order to also replicate
the movement of the device main body 4.
[0074] As a typical example, the controller 25 instructs to the
movement measuring section 24 that from the time of mounting sensor
to the time of ending measuring, the movement information is
measured. The period of time is the most efficient in analyzing the
movement of the measuring device 1 due to user's handling by
synchronizing the movement in measuring the glucose concentration.
However, in a case where amount a memory as the recording section
27 is adequate, or in a case where the amount of the moving is
transmitted real time to devices outside via the communication line
3, it is fine to instruct measuring the movement information other
than in the period of time. By that, additional effect in which a
way of using the measuring device 1 by analyzing user's handling
other than the movement in measuring the glucose concentration is
obtained can be attained. By this, the influence to the result of
measuring, indirectly by the handling, in the period other than the
period between the time of mounting the sensor and the time of
ending measuring is considered.
[0075] The controller 25 instructs the communication section 26 to
transmit the measuring administration data recorded in the
recording section 27 to the administrating device 2 via the
communication line 3 in a prescribed timing. The prescribed timing
includes a case in which the user instructs to do and a case in
which the controller 25 spontaneously does. In the case in which
the user instructs transmitting the measuring administration data
by the input section 6, when the communication section 26
establishes the communication with the administrating device 2 via
the communication line 3, the communication section 26 immediately
transmits the measuring administration data. When the communication
section 26 does not establish the communication with the
administrating device 2, the controller 25 instructs the
communication section 26 to establish the communication with the
administrating device 2. The communication section 26 transmits the
measuring administration data after the communication is
established. Alternatively, it is fine that the controller 25 plans
proceeding in the controller 25 to transmit the measuring
administration data when the communication section 26 establishes
the communication with the administrating device 2 next time.
[0076] When the user instructs transmitting the measuring
administration data, it is preferable that the controller 25 can
select one or plurality of when the user measure, who measures, and
whom is measured by using the display section 5 and the input
section 6.
[0077] When the controller 25 spontaneously transmits the measuring
administration data, the communication section 26 performs the
transmission operation in either timing described below. The user
can prescribe which timing the communication section 26 performs
the transmission operation. The timing can be: [0078] 1) when the
controller 25 records the measuring administration data in the
recording section 27 after the glucose concentration is measured;
[0079] 2) when the communication section 26 establishes the
communication with the administrating device 2 via the
communication line 3; [0080] 3) when the measuring administration
data is requested by the administrating device 2 to be transmitted;
[0081] 4) when the batter disposed in the device main body 4 is
being charged; [0082] 5) when the power source of the measuring
device 1 is instructed to be off; and [0083] 6) the glucose
concentration measured by the measuring section 23 is determined to
be abnormal.
[0084] In a case where transmitting the measuring administration
data is scheduled in the timing in which the communication between
the measuring device 1 and administration device 2 is not
established, the communication section 26 performs establishing the
communication between the communication section 26 and the
administrating device 2 each time.
[0085] Next, constituent elements of the administrating device 2
are described with reference to FIG. 6. FIG. 6 is a block diagram
of the administrating device 2. As shown in FIG. 6, the
administrating device 2 includes a device main body 8 including a
controller 28, a movement determining section 29, a communication
section 30, and a recording section 31, a display section 9, and an
input section 10. The device main body 8 is realized by, for
example, a personal computer or a server.
[0086] The controller 28 controls all the elements which
constitutes the administrating device 2. The controller 28 can be
realized by including an ordinary CPU, an operating system
implemented there, a program, and the like.
[0087] The movement determining section 29 obtains the measuring
administration data transmitted from the measuring device 1 by
receiving the instruction form the controller 28. The movement
determining section 29 analyzes and determines the movement
information of the measuring device 1 by using the measuring
administration data.
[0088] The communication section 30 performs the data transmission
and reception with the administrating device 2, the measuring
device 1 or the like via the communication line 3. The
communication section 30 can be arranged to communication
one-on-one with the measuring device 1 being particular, or to
communicate one-to-many with a plurality of measuring devices
1.
[0089] The recording section 31 records various data and
information. The recording section 31 is recordable of the
measuring administration data transmitted from the measuring device
1. Also, the recording section 31 is recordable of patient
information and nurse information input by the input section 10 or
the like. Further, the recording section 31 is recordable of
information presented to the user by the display section 9. The
recording section 31 can be disposed in the device main body 8 as
shown in the figure, but a large storage device which is externally
connected can be used.
[0090] The display section 9 displays contents instructed by the
controller 28. The display section 9 can be realized, for example,
by a liquid crystal display.
[0091] The input section 10 is used by the user to input the
instruction and the data to the controller 28. FIG. 1 shows a
keyboard as an example, but not limited to this. The input section
10 can be realized by combining a pointing device such as a mouse
and a reading device such as a barcode reader, an electric card
reader, or a scanner.
[0092] The administrating device 2 performs various administration
processes. The administrating device 2 administrates a plurality of
the measuring devices 1. Also, the administrating device 2
administrates database of the measurer and the subject person.
Also, the administrating device 2 administrates correction
information of the biosensor 7. The administrating device 2
presents each administrating status to the user by using the
display section 9.
[0093] The administrating device 2, for example, determines whether
or not maintenance is necessary on the basis of a history of the
use or a status of the use of the measuring device 1. By this, the
administrating device 2 can present whether or not the maintenance
is necessary to the user. The administrating device 2 can display a
tendency in changes, in a chart, of the glucose concentration for
each subject person by using a plurality of the results of
measuring the glucose concentration. Further, the administrating
device 2 calculates consumption of the disposable biosensor 7 which
is consumable by extracting the identification of the biosensor 7
from the measuring administration data. By this, the administrating
device 2 can present the inventory information of the biosensor 7,
which the user can use, to the user by referring to the inventory
information of the biosensor 7 with in a facility.
[0094] As one of various programs that the administrating device 2
implements, a handling analyzing program performing analyzing the
handling of the user on the basis of the movement information of
the measuring device 1 is included. The handling analyzing program
is one of programs implemented by the controller 28. The
administrating device 2 can use a processing device which performs
dedicatedly the handling analyzing program. Because of this, a
functional section which performs the handling analyzing program is
shown as the movement determining section 29 in FIG. 6.
[0095] The controller 28 receives the measuring administration data
which has received by the communication section 30 and which has
been sent from the measuring device 1 by the communication section
30. The controller 28 records, as needed, the measuring
administration data, which has been received by the communication
section 30, in the recording section 31. At this time, the
controller 28 records each of the measuring administration data in
the recording section 31 by labeling in order for the measuring
administration data to be extractable for each of the measurer
identifications. By this, the controller 28 administrates the
measuring administration data for each of the measurer.
[0096] The controller 28 instructs the movement determining section
29 to analyze the movement information, when instructed from the
user via the input section 10, or spontaneously. When instructed by
the user to analyze the movement information, the controller 28
displays in the display section 9 a list of the measuring
administration data recorded in the recording section 31. The list
of the measuring administration data includes, for example, the
measurer identification and the labels. By this, the controller 28
makes the measuring administration data selectable as an object for
the user to instruct analyzing the movement information.
[0097] The controller 28 spontaneously instructs the identifying
part 29 to analyze the movement information, when conditions 1)-6)
below. The conditions are examples, and the user freely set. By
this, the result of analyzing the movement information is stored
spontaneously in the recording section 31. The controller 28
displays by the display section 9 the result of analyzing the
movement information, when the user instructs browsing the result
of analyzing the movement information. [0098] 1) when the measuring
administration data received by the communication section 30
includes an abnormal flag showing abnormality of the glucose
concentration; [0099] 2) when the measurer identification which is
included in the measuring administration data received by the
communication section 30 is included none of the plurality of
measuring administration data recorded in the recording section 31
(when the user who has the measurer identification measures the
glucose concentration); [0100] 3) when the number of recording in
the recording section 31 the measuring administration data
including the measurer identification included in the measuring
administration data which is received by the communication section
30 is less than a prescribed number (when experience in measuring
the glucose concentration of the user having the measurer
identification is few); [0101] 4) when a prescribed period of time
elapses from previously recording the measuring administration data
in the recording section 31 which includes the measurer
identification included in the measuring administration data
received by the communication section 30 (when the user having the
measurer identification measures the glucose concentration after
such a long time); [0102] 5) when the number of recording in the
recording section 31 the measuring administration data including
the measurer identification included in the measuring
administration data which is received by the communication section
30 is more than a prescribed number (when experience in measuring
the glucose concentration of the user having the measurer
identification is adequate and the user is experienced); and [0103]
6) a prescribed period of time elapses after analyzing the movement
information for each of the user having the measurer
identification.
[0104] The movement determining section 29 reads the measuring
administration data which is designated from the recording section
31, when the controller 28 instructs analyzing the movement
information. The movement determining section 29 extracts the time
of mounting sensor, the time of the sample deposition, the time of
starting measuring, the time of ending measuring and the movement
information synchronized with those from the measuring
administration data which has been read.
[0105] Analyzing the movement information is performed by the
movement determining section 29 in a first period (first period,
t1-t2), a second period (second period, t2-t3), and a third period
(third period, t3-t4), as shown in FIG. 7. The first period is a
period from the time of mounting the sensor t1 to the time of the
sample deposition t2. The second period is a period from the time
of the sample deposition t2 to the time of starting measuring t3.
The third period is a period from the time of starting measuring t3
to the time of ending measuring t4. For example, FIG. 7 is an
example of the changes in the degree of the movement of the device
main body 4 in the X axis 4X which is shown in FIG. 5. The
direction of the main body 4 in the X axis 4X is along the
direction of mounting the biosensor 7 to the device main body 4. A
horizontal axis is for time elapsing, and shows from time before
notifying the detection of mounting the biosensor 7 to the time of
ending measuring the glucose concentration. A vertical axis shows
average values of absolute values of the degree of the changes in
the movement transmitted by the movement measuring section 24.
Larger the degree of the changes in the movement, larger and more
abruptly the device main body 4 is moved. As FIG. 7 shows, a degree
of the movement M1 becomes high, as movement is added to the device
main body 4 from the biosensor 7 by the handling in mounting the
biosensor 7 to the device main body 4. After that, a degree of the
movement M2 arises by the movement added to the device main body 4
from a finger of the user via the biosensor 7 by the handling when
depositing the blood on the tip of the biosensor 7. After that, a
small degree of the movement M3 arises by the handling of the user
holding to maintain the posture of the device main body 4. After
the time of the sample deposition t2, when the device main body 4
is placed on a table or the like, no degree of the movement arises
around a period from the time of starting measuring t3 to the time
of ending measuring t4.
[0106] Analyzing the movement information in each period is
performed by comparing each threshold value with the degree of the
changes in the movement in the X axis 4X, the Y axis 4Y, and the Z
axis 4Z of the measuring device 1 per unit time. The movement
determining section 29 analyzes that the movement of the measuring
device 1 is slow within an allowable range, when the degree of the
changes in the movement is smaller than the threshold value. The
movement determining section 29 analyzes that the movement of the
measuring device 1 is fast and over the allowable range, when the
amount of changes is more than the threshold value. Whether the
movement of the measuring device 1 is slow or fast means whether a
momentary acceleration is large or small, and in other words,
whether or not an impact to the measuring device 1 is large or
small.
[0107] The threshold value can be same for all the three axes in
each of all the periods. Also, the threshold value can be different
in each period corresponding to objectives. The optimum value for
the threshold value corresponding to the objective in each period
is obtained by experiments and situations with conditions for
attaining the objectives
[0108] An example is described for a threshold value being
different in each period. The first period is a period from the
time in which the biosensor 7 is mounted to the device main body 4
to the time in which the blood is deposited to the biosensor 7.
Therefore, the movement of the measuring device 1 for measuring
mainly in the first period is whether or not an impact with a
degree being large enough such that the biosensor 7 has the
abnormality. The biosensor 7 has a long rectangular shape, as shown
in FIG. 2. For this reason, the biosensor 7 easily has a breakage
such as a bent, when the impact applies to the measuring device 1
in the longitudinal direction due to the handling while the
biosensor 7 is inserted to the measuring device 1. Then, among the
thresholds values in the first period, the threshold value
particularly in the X axis 4X (forward-and-backward direction of
the device main body 4, insertion direction of the biosensor 7) is
for detecting the breakage of the biosensor 7. By this, the
allowable range is made narrow in order to determine easily the
fast movement when the device main body 4 is moved in the
forward-and-backward direction, by making the threshold value in
the X axis 4X lower.
[0109] On the other hand, the handling includes moving the device
main body 4 left and right in order for the user to locate the
biosensor 7 at a point (location) of the subject person for the
deposition. Also, the handling includes putting the device main
body 4 on a table or the like after mounting the biosensor 7. These
handlings are not easily directly related to the breakage of the
biosensor 7. Thus, the threshold value of the Y axis 4Y
(right-and-left direction of the device main body 4) and the
threshold value of the Z axis 4Z (up-and-down direction of the
device main body 4) in the first period are made larger. By this,
the allowable range is made wider by making the threshold values in
the Y axis 4Y and the Z axis 4Z higher in order not to determine
that the movement of the device main body 4 and biosensor 7 in the
right-and-left direction and the up-and-down direction of the
device main body 4 is the fast movement.
[0110] In the second period and the third period, the blood as
liquid is deposited on the biosensor 7. In the second period, it is
necessary that the blood constantly expands and comes in the sample
supply route 15 in the biosensor 7. In the third period, it is
necessary that the blood constantly exists on the counter electrode
17 of the biosensor 7, the measurement electrode 18, and the
detection electrode 19 after expanding in the sample supply route
15. The second period and the third period have objectives in
measuring the glucose concentration with high accuracy. The
allowable ranges of the movement in the X axis 4X, the Y axis 4Y,
and the Z axis in 4Z in order to satisfy the condition is set and
each is made to be the threshold value. Thus, it is preferable to
make the allowable range narrower by making the threshold value in
the second period and the third period lower than that of the first
period.
[0111] The movement determining section 29 transmits the result of
determining whether or not the movement information in each of the
first, second, and the third periods exceeds (becoming an error)
the threshold value (allowable range) to the controller 28 after
analyzing the movement information. The controller 28 records in
the recording section 31 the result of determining with which
associating the measuring administration data.
[0112] At this time, the controller 28 search the result of
determining in the past, when there are cases in which one or a
plurality of the result of determining in the first, second, and
third periods, which is transmitted from the movement determining
section 29, is determined as erroneous. In other words, the
controller 28 extracts the measurer identification included in the
measuring administration data in which the movement information is
completed in analyzing this time from the measuring administration
data recorded in the recording section 31. The controller 28
extracts the result of determining in analyzing the movement
information being associated with the measuring administration data
including the measurer identification that is the same as the
measurer identification extracted. The controller 28 obtains the
sum of the number of the errors in the result of determining in the
past, which is extracted. The controller 28 adds one error this
time to the sum of the errors. The controller 28 determines that
user's instruction is necessary, when the sum of the number of the
errors is over a prescribed number.
[0113] The controller 28 can reveal a fact that there are multiple
times in measuring with the measuring device 1 moving over the
allowable range, by adding the number of the errors, in measuring
which the user has performed by now. The allowable range for the
degree of the movement is set for measuring the glucose
concentration normally, on the above mentioned conditions.
Therefore, the fact that the number of the errors becomes over the
prescribed number means that there is a problem in the handling of
the user in handling the measuring device 1.
[0114] Then, the controller 28 implements an instruction program
for showing an instruction content which improves the handling of
the user. The simplest example is to display a warning on the
display section 9 of the administrating device 2. For example,
"please do not move abruptly the measuring device after the
deposition of the blood" or the like is displayed for the user with
the handling recognized as erroneous in the second period.
Alternatively, "please instructs not moving the measuring device
abruptly after the deposition of the blood" or the like is
displayed because the user is an instructor. Further, it is fine to
display a video of the movement of measuring in order for the user
to learn the handling. It is preferable to emphasize comments for
the movement which particularly needs attention in each scene, in
displaying the instruction video. Alternatively, not only showing
the instruction on the monitor, but it is fine displaying to
encourage taking a training of the handling, which is provided by
facilities, in order for the user to receive a practical
instruction.
[0115] Moreover, it is fine that the controller 28 implements a
simulation program to replicate the movement of the measuring
device 1 on the basis of the movement information. The controller
28 displays on the display section 9 the status of movement and the
measuring device 1 as a result of the simulation. At that time, the
controller 28 displays warning regarding in which period the
movement is problematic on the basis of the result of determining
from the movement determining section 29.
[0116] These instruction contents to the user are not only
displayed on the display section 9 of the administrating device 2,
but are fine to be displayed on the display section 5 of the
measuring device 1. The controller 28 instructs the communication
section 30 to transmit the measurer identification of the user who
needs the instruction and the instruction content to the measuring
device 1, when the above mentioned instruction is determined to be
necessary. The controller 25 of the measuring device 1 records the
measurer identification which is received from the administrating
device 2 and the instruction content in the recording section 27.
The controller 25 displays the instruction content on the display
section 5, when the measurer identification read from the input
section 6 and the recorded measurer identification match, in other
words when the user who needs the instruction is about to measure.
By this, the measuring device 1 can instructs the user about the
handling when handling the device main body 4.
[0117] As FIG. 8 shows, the administrating device 2 communicates
with a plurality of measuring devices 1a-1c, and receives the
measuring administration data from each of the plurality of
measuring devices 1a-1c. In this case, the controller 28 records
the recording section 31 by associating measuring device
identification which is a particular number for each of the
measuring devices 1a-1c with the measuring administration data. In
the above mentioned chain of analyzing the movement information, it
is fine to search differently for each of the measurer
identification, when searching the measuring administration data
for the same measurer identification. This is a search for the
result of the particular measuring device by the particular
measurer. Alternatively, it is fine to search for measuring
administration data against all the measuring administration data
recorded in the recording section 31, regardless of the measuring
device 1 being a source of obtaining. This is a search for all the
results of the particular measurer, while the measuring device is
not specified.
[0118] Like the latter, the measuring administration data
associated with the measurer identification is continuously
administered, and is used for analyzing the handling by searching
regardless of the measuring device 1 as the source of obtaining.
For example, it is effective for measuring the glucose
concentration by using randomly the measuring device 1 which is
usable for a nurse at a large hospital or the like at that time.
Also, it is effective in a case in which the measuring device 1 is
replaced for use because of breakage or maintenance.
[0119] It is fine to prevent measuring newly until the user
confirms the instruction program or the warning displayed, when the
controller 28 of the administrating device 2 determines that the
particular user needs the instruction. For example, the controller
28 transmits information to all the measuring devices 1 about a ban
in measuring which is associated with the measurer identification
given to the particular user for instruction. The controller 25 of
the measuring device 1 starts monitoring the measurer
identification which is input after receiving the information about
the ban from the administrating device 2. Then, the controller 25
issues warning when the measurer identification which is banned to
be measured and the same measurer identification are read. For
example, the controller 25 displays that the measurer
identification is banned to be measured, and displays the
instruction to confirm the instruction program presented on the
administrating device 2 or the measuring device 1 on the display
section 5 of the measuring device 1.
[0120] The controller 28 can confirm that the user confirms the
instruction program by using the input section 10 of itself. In a
case in which the controller 28 or the user confirmed the
instruction program in one of the measuring devices 1, the
controller 28 can recognize by transmitting from the measuring
device 1. By this, the controller 28 recognizes the instruction for
the handling to the user. After that, the controller 28 of the
administrating device 2 transmits information for dismissing the
ban for measuring to all the measuring devices 1.
[0121] In a case in which the movement information is analyzed as a
condition to include the flag for the abnormality in the measuring
administration data, the controller 28 confirms whether the
abnormality is because of the handling of the user or not, based on
the result of determining of the above mentioned movement
determining section 29. At this time, the controller 28 confirms
the result of determining which is transmitted, after the movement
information is analyzed in the movement determining section 29. The
controller 28 displays in the display section 9, as if the abnormal
value arises for the glucose concentration due to a factor other
than the handling of the user when each of the first to third
periods is determined as erroneous. The controller 28 transmits the
measuring administration data which includes the flag for the
abnormal value of the glucose concentration to an information
collecting device differently configured from the administrating
device 2, in order to analyze the abnormal value precisely.
[0122] The configuration for it is shown in FIG. 9. FIG. 9 shows an
example of the liquid sample measuring system including an
information collection function to analyze precisely. In the liquid
sample measuring system, the administrating device 2 and the
information collecting part 33 are connected by a network 32 using
a dedicated line or the internet. The information collecting part
33 is disposed at an administrating department of a sales company
or a manufacturer of the measuring device 1, or at an examining
department or a monitoring department of a medical institution. The
measuring administration data transmitted from the administrating
device 2 is consolidated to the information collecting part 33. The
consolidated measuring administration data is used for examining
for countermeasures or the like by specialist precisely analyzing
the factor of the abnormal value.
[0123] The information collecting part 33 notifies an involved
person of the medical institution immediately when the abnormality
is clinical as a result of analyzing the measuring administration
data. This notice is performed by transmitting in email or
transmitting a signal to boot communication means of a device which
the involved person has such as a beeper (beeper). It is fine for
the device that the involved person has to include the measuring
device 1 other than a mobile device such as a mobile phone.
[0124] According to the liquid sample measuring system of the
present embodiment, as mentioned above, it is possible to determine
whether or not the accuracy of measuring decreases due to the
handling of the user, and implement. By this, it is possible to
decrease variation of the result of measuring of the measuring
device 1.
[0125] In the present embodiment, it has discussed about an example
in which an acceleration sensor as the movement measuring section
is included in the device main body, but it is fine to include two
acceleration sensors. It is possible to analyze more accurately the
movement information because the movement of the device main body 4
is precisely replicated as long as these multiple acceleration
sensors are properly located.
[0126] Further, it is preferable to replicate not only the degree
of moving but an angle of the device main body 4 by combining a
plurality of the acceleration sensors and angle sensors. By this,
the posture of the device main body 4 when measuring, from an angle
of the device main body 4 can be known. By this, there is an effect
on the measuring device 1 which handle the liquid sample to be able
to instruct the user by considering moving against the gravity on
the liquid.
[0127] It is fine that one or a plurality of a two-axes
acceleration sensors instead of a three-axes acceleration sensor as
the movement measuring section 24.
[0128] It is fine that the information collecting part 33
implements and transmits the result to the administrating device 2,
instead of the administrating device 2 implementing analyzing the
movement information.
Second Embodiment
[0129] The above mentioned first embodiment of the liquid sample
measuring system is described as an arrangement in which the
administrating device 2 analyzes the movement information. In
contrast, the liquid sample measuring system of a second embodiment
as analyzing the movement information by the measuring device 1 is
described.
[0130] FIG. 10 shows a block diagram of the measuring device 1
which can analyze the movement information. Description of the same
configuration and movement shown in the block diagram in FIG. 3 are
omitted by using the same reference characters. The measuring
device 1 is different from the configuration shown in FIG. 3
because including a movement determining section 34 inside the
device main body 4. The movement determining section 34 explained
in the first embodiment functions same as the movement determining
section 29 inside the administrating device 2.
[0131] The controller 35 is a thing in which the controller 28
inside functions of the administrating device 2 is added to a
controller 25 inside the measuring device 1 described in the first
embodiment. In other words, in addition to controlling the
measuring device 1, the controller 35 instructs analyzing the
movement information to the movement determining section 34,
determines whether or not it is necessary to instruct the user on
the basis of the result of determining from the movement
determining section 34, and controls and presents the instruction
program, which are performed by the controller 28 of the
administrating device 2.
[0132] FIG. 11 is a flowchart showing the movement of the measuring
device 1 having the instruction function to the user by the
measuring device 1 of the present embodiment.
[0133] In step S1, the timing in which the biosensor 7 is mounted
to the sensor wearing part 22 by the user is detected by the sensor
wearing detection section 22b. The controller 35 recognizes the
biosensor 7 being mounted by the notice from the sensor wearing
detection section 22b. Before step S1, the preparation of inputting
the user identification, the patient identification, and the
identification of the biosensor 7 which are necessary for measuring
is completed. The controller 35 starts measuring the amount of
moving of the device main body 4 by the movement measuring section
24 as well, after mounting the biosensor 7.
[0134] In the present embodiment, it is fine that the measuring
device 1 is the measuring device 1 for a person who is the user as
the measurer and the patient as the subject person at the same
time. In this case, inputting the user identification (measurer
identification) and the patient identification (subject person
identification) which is implemented each time when the measurer
and the subject person is not same is omitted. Therefore, when the
measuring device 1 is for personal use, and when the biosensor 7 is
detected in step S1 to be mounted to the sensor wearing part 22, it
is fine that the controller 25 controls the display section 5 and
the input section 6 to make the user input the identification of
the biosensor 7.
[0135] In step S2, the controller 35 confirms whether or not there
is the measuring administration data, which is the result of
measuring in the past, in the recording section 27 more than a
prescribed times (for example 3 times). When the measuring
administration data exists more than the prescribed times, the
controller 35 extracts the prescribed number of the result of
analyzing the movement information by chronologically going back
from the measuring administration data which is closest to the
present time. The controller 35 determines that the instruction is
necessary for the handling, when the result of analyzing of the
extracted movement information is all erroneous. On the other hand,
partially or entirely the result of analyzing of the movement
information is not erroneous, the controller 35 determines that the
instruction for the handling is not necessary.
[0136] When the instruction for the handling is determined to be
necessary in step S2, the controller 35 proceeds to step S3. In
step S3, the controller 35 displays "confirmation of precaution is
necessary" in the display section 5. By this, the controller 35
presents encouragement to the user of confirming the instruction
program. After that, when the user requests confirming the
instruction program by using the input section 6, the controller 35
displays the instruction program which is stored in the recording
section 27 on the display section 5. On the other hand, when the
instruction for the handling is not necessary in step S2, the
controller 35 waits for the blood being deposited, and proceeds to
step S4.
[0137] In step S4, the blood is deposited on the biosensor 7, and
the glucose concentration is measured by the measuring section 23,
as discussed in the first embodiment. At this time, the controller
35 detects the blood being deposited on the biosensor 7, the
movement information from the time when the sensor is mounted to
the time of the sample deposition (first period) is recorded in the
recording section 27. Also, when the blood is lead inside the
biosensor 7 and measuring the glucose concentration is started, the
controller 35 records in the recording section 27 the movement
information from the time of sample deposition to the time of
starting measuring (second period). Further, when measuring the
glucose concentration is ended, the controller 35 records in the
recording section 27 the movement information from the time of
starting measuring to the time of ending measuring (third period).
The result of measuring the glucose concentration and the movement
information are clumped together and recorded in the recording
section 27 as the measuring administration data.
[0138] The blood deposition is detected on the biosensor 7 during
step S3, it is forced to finish step S3 and proceed to step S4. For
example, even in a stated in which displaying the instruction
program is performed or in which the request for displaying the
instruction program from the user is waited, it proceed to step S4.
In a case in which the blood is prepared in an emergency situation
and the user performs puncturing the patient beforehand, this
prevents the prepared blood from being dry and being wasted while
waiting the instruction program for ending. The controller 35
records whether the instruction program of step S3 is completed or
interrupted as a history in the recording section 27, when
proceeding to step S4.
[0139] The controller 35 proceeds to step S5 and instructs the
movement determining section 34 to analyze the movement
information, when measuring the glucose concentration ends, and the
measuring administration data is recorded in the recording section
27. At this time, the movement determining section 34 reads the
movement information recorded in step S4 from the time when the
sensor is mounted to the time of ending measuring. Then, the
movement determining section 34 analyzes the movement information
in each of the first, second, and third periods for the read
movement information, just as the movement determining section 29
described in the first embodiment.
[0140] Next, the controller 35 proceeds to step S6 and determines
the display contents on the display section 5. When measuring the
glucose concentration in step S4 ends, the controller 35 reads the
measuring administration data recorded on the recording section 27
from the recording section 27, and the result of measuring the
glucose concentration and the result of analyzing the movement
information are confirmed.
[0141] First, the controller 35 confirms whether or not the result
of measuring the glucose concentration is a measuring value within
the range. Next, the controller 35 confirms whether or not there is
a period in which the result of analyzing the movement information
is erroneous. The controller 35 chooses the display content on the
display section 5 among a plurality of display contents which are
prepared beforehand, on the basis of the result of determining the
glucose concentration and the result of analyzing the movement
information. Here, the range of the measuring value for determining
the result of measuring the glucose concentration is further wider
than the range necessary for warning the user for normal low
glucose concentration and normal high glucose concentration. For
this reason, a threshold value to determine the high glucose
concentration and a threshold value to determine the low glucose
concentration are set for the glucose concentration. Further, a
range with a threshold value larger than the threshold value for
the high glucose concentration and a threshold value lower than the
low threshold value for the low glucose concentration in order to
determine an abnormal measuring range is set. The range set between
the two threshold values in order to determine the abnormal
measuring range is a range for not determining the abnormal range
and the "prescribed range" which will be described hereinafter.
[0142] In a case in which the result of measuring the glucose
concentration is within the prescribed measuring range and there is
no period in which the result of analyzing the movement information
is erroneous, processing advances in step S7. The controller 35
displays at least the result of measuring (display A) the glucose
concentration which has been measured on the display section 5. At
this time, when the result of measuring the glucose concentration
is within the prescribed range but determined as the high glucose
concentration or the low glucose concentration, the controller 35
makes the display section 5 display also warning for the low
glucose concentration or the high glucose concentration.
[0143] In a case in which the result of measuring the glucose
concentration is within the prescribed measuring range and there is
a period in which the result of analyzing the movement information
is erroneous, processing advances in step S8. The controller 35
makes the display section 5 display (display B) at least the result
of measuring the glucose concentration which has been measured, and
the instruction program to the user. For example, in a case in
which the degree of the movement in the second period is determined
to be erroneous, "please do not move abruptly after the blood
deposition" as the instruction program is displayed. At this time,
when the result of measuring the glucose concentration is within
the prescribed range but determined as the low glucose
concentration or the high glucose concentration, displaying the
warnings of the low glucose concentration or the high glucose
concentration is also performed.
[0144] In a case in which the result of measuring the glucose
concentration is outside the prescribed measuring range and there
is no period in which the result of analyzing the movement
information is erroneous, processing advances in step S9. The
controller 35 makes the display section 5 not display (display C)
the result of measuring the glucose concentration but display the
warning of the measuring error. At this time, it is fine that the
controller 35 displays the instruction of measuring again.
[0145] In a case in which the result of measuring the glucose
concentration is outside the prescribed measuring range and there
is a period in which the result of analyzing the movement
information is erroneous, processing advances in step S10. The
controller 35 makes the display section 5 not display the result of
measuring the glucose concentration but display the warning of the
measuring error and the instruction program to the user. For
example, in a case in which the degree of the movement in the
second period is determined to be erroneous, "please do not move
the measuring device abruptly after the blood deposition" as the
instruction program is displayed. Further, the controller 35 makes
the display section 5 display the instruction to measure again.
[0146] Like this, in the present embodiment, a timing in which the
movement information is analyzed is right after the glucose
concentration is measured by the measuring section 23. With regards
to the timing, the measuring device 1 instructs the user in the
handling as needed before measuring the glucose concentration, or
right after measuring the glucose concentration, or the both.
[0147] Instructing the user in the handling before measuring the
glucose concentration has an effect of encouraging doing the
handling for measuring with strong notion because the user has a
fresh memory of the contents of the instruction. For this, it is
effective as a countermeasure against the decrease of the measuring
accuracy due to user's handling, when measuring the glucose
concentration is about to start.
[0148] Also, instructing the user right after measuring the glucose
concentration has an effect of pointing out things which have to be
improved, while the user has the fresh memory of his/her handling
right after measuring. For this, it is effective as a
countermeasure against the decrease of the measuring accuracy due
to user's handling, when the user measures the glucose
concentration from the next time.
[0149] Like this, the display section 5 can display the instruction
program before measuring the glucose concentration on the basis of
the result of determining of the movement recorded in the recording
section 27. Also, the display section 5 can displays the
instruction program right after measuring the glucose concentration
on the basis of the result of determining the movement in the
periods including the one in which measuring is being performed
after measuring the glucose concentration.
[0150] Further, the present embodiment discloses a second timing to
analyze the movement information. The second timing is when the
user, or a pursuer of the medical institution such as a doctor or a
medical coordinator of a medical institution instructs the
controller 35 to analyze the movement information by using the
input section 6.
[0151] Time in which the pursuer of the medical institution
instructs analyzing the movement information is when, for example,
an individual patient comes to a hospital with the measuring device
1 which is used at home, and takes a medical examination by a
doctor. The doctor confirms the measured value of the glucose
concentration in a daily life of the patient recorded in the
recording section 27 of the measuring device 1, and can instruct
the patient in dispensing and consult daily the daily life. On this
occasion, confirming whether or not the daily handling, when the
patient measures, is properly performed by analyzing the movement
information.
[0152] The controller 35 makes the display section 5 display a menu
and receives the instruction from the user, as a movement other
than when measuring the glucose concentration. The menu which the
display section 5 displays includes an item to display the measured
values of the glucose concentration measured in the past and
recorded in the recording section 27, for example. Other items
include maintenance of the measuring device 1 and the like. In the
item of the maintenance, there is an item for instructing analyzing
the movement information.
[0153] When instructed from the user to analyze the movement
information via the input section 6, the controller 35 instructs
the movement determining section 34 to analyze the movement
information. When the user selects the items for analyzing the
movement information from the menu displayed on the display section
5 by using the input section 6, the controller 35 makes the display
section 5 display the result of measuring the glucose concentration
and the date and the time on which the result of measuring is
obtained, namely the date and the time on which measuring the
glucose concentration is performed from the recording section 27.
When there are the results of measuring for more than multiple time
of measuring in the recording section 27, it is displayed in the
list.
[0154] Then, the controller 35 makes the user select, in analyzing
the movement information, in which date and time in which the
glucose concentration is measured, in an interactive way by using
the display section 5 and the input section 6. The controller 35
instructs the movement determining section 34 which date and time
the movement information is analyzed by following the input from
the input section 6. The movement determining section 34 reads,
from the recording section 27, the movement information for the
date and the time instructed by the controller 35, analyzes the
movement information, and transmits the result of analyzing to the
controller 35. The controller 35 makes the display section 5
display the result of measuring the glucose concentration as
mentioned above and the date and time in which the result of
measuring is obtained, as well as the result of analyzing the
movement information which is transmitted by the movement
determining section 34. It is fine that the user instructs
analyzing, at one time, the movement information obtained from a
plurality of times of measuring.
[0155] By this, for example, when the abnormal value is recorded in
the measured value of the glucose concentration, a doctor confirms
whether or not it is due to the handling of the patient, and
determines how to respond to the patient. Also, when the abnormal
value is not recorded in the measured value of the glucose
concentration, whether or not there is a problematic movement in
the handling is confirmed. By this, it is possible for the doctor
to instruct the patient for the handling in order to suppress the
decrease in the accuracy in measuring due to patient's handling
being inappropriate which will happen in the future.
[0156] According to the measuring device of the present embodiment,
it is possible that the measuring device 1 alone determines whether
or not the accuracy of measuring decreases due to the handling of
the user, and takes an appropriate countermeasure. By this, the
variation of the result of measuring by the measuring device 1 can
be decreased.
Third Embodiment
[0157] The measuring device 1 of the present embodiment is, in
addition to the above mentioned embodiments, an arrangement in
which it is possible to equip the cover 36 on the device main body
4. FIG. 12 is a view of an appearance of the measuring device which
mounts the cover 36 on the device main body 4. FIG. 13 is a block
diagram of the measuring device on which the cover is possible to
be mounted.
[0158] As FIG. 12 shows, the measuring device 1 of the present
embodiment is a thing in which the cover is mounted on the device
main body 4 which measures the movement information as mentioned
above. The cover 36, as shown in the figures, is detachably mounted
on the device main body 4 so as to cover from a side surface on
which the biosensor 7 is mounted to the outside of the device main
body 4. In FIG. 12, the cover 36 is shaped in a way to cover an
upper part of the input section 6, but it is fine to cover the
upper part of the display section 5. In contrast, it is also fine
that the cover 36 does not cover the display section 5 and the
input section 6, but is shaped in the way to cover the side surface
on which the biosensor 7 is mounted. Alternatively, it is also fine
that the cover is formed so as to cover entirely the device main
body 4.
[0159] The purpose of the cover 36 being mounted on the device main
body 4 is to prevent the blood to be erroneously deposited on the
device main body 4 when the blood of the subject person is to be
deposited to the biosensor 7. Therefore, the cover 36 is replaced
each time when the glucose concentration is measured, or when the
blood is deposited. By this, it is possible to prevent that
infection happens to a third person other than the subject person
by adhering the blood on the device main body 4.
[0160] For this reason, the measurer (user) must keep the cover 36
mounted on the device main body 4 as doing (handling) in measuring,
and if cannot, the instruction to the user is necessary.
[0161] Then, as FIG. 13 shows, a cover detection section 37 is
added to the device main body 4 of the measuring device 1. The
cover detection section 37 detects whether or not the cover 36 is
mounted on the device main body 4 and transmits to the controller
25. An ordinary sensor is fine for the arrangement to detect the
cover 36 being mounted on the device main body 4. For example, the
cover detection section 37 is constituted by a mechanical
contact-type switch which switches on and off by physical contacts
when the cover 36 is mounted on the device main body 4.
Alternatively, it is fine that the cover detection section 37 is
arranged to have an optical sensor which detects the cover 36 being
mounted depending on changes of an amount of received light due to
the cover 36 covering the device main body 4. Other than that, a
thing that detects by using electrical or magnetic characteristic
is fine. When the cover detection section 37 detects the cover 36
being mounted by the optical sensor, it is fine to adjust contrast
and light intensity of the display section 5 depending on the
received amount of light by the cover detection section 37. For
example, in a case in which the cover 36 covers the display section
5, when the cover 36 is mounted, brightness and lightness of the
display section 5 is increased in order to prevent that the display
section 5 is difficult to see by the existence of the cover 36.
[0162] The controller 35 records in the recording section 27 by
adding in the measuring administrating data the result of
detecting, which the cover detection section 37 transmits, whether
or not the cover 36 is mounted to the device main body 4 from the
time of mounting the sensor to the time of ending measuring.
[0163] The controller 28 of the administrating device 2 detects
whether or not the cover 36 is mounted when the movement
information is analyzed as described in the above mentioned
embodiment. The controller 28 displays the warning or the
instruction program to the user when the cover 36 is not mounted
while measuring the glucose concentration. For example, "it is
necessary to mount the cover while measuring the glucose
concentration" or the like is displayed.
[0164] Like this, according to the liquid sample measuring system
of the present embodiment, the user, in addition to determining the
influence of the decrease in the measuring accuracy by user's
handling, it can be observed whether the user measures in a right
procedure and the correction can be performed if wrong.
[0165] In the beginning, the cover 36 is fine to have no opening on
the side surface on which the biosensor 7 is mounted and the cover
36 is fine to cut by an end of the biosensor 7 which is held by the
device main body 4 when the biosensor 7 is mounted to the device
main body 4.
[0166] The sensor wearing part 22 is configured in a middle part of
the side surface of the device main body 4, and it is fine that the
cover 36 can be mounted regardless of which direction an upper
surface and a lower surface face. Alternatively, in a case in which
the sensor wearing part 22 is configured at a place off from the
middle part, it is fine to display on the cover 36 in order to
recognize the direction for mounting to the device main body 4.
Further, depending on forming, it is fine that the user recognizes
the direction of mounting. For example, when a translucent material
is used for the cover 36, a degree of transparency of a surface
corresponding to the display section 5 is high, and a degree of
transparency of an opposite side surface is low.
[0167] The example of measuring the glucose concentration in the
blood in which the electrochemical biosensor 7 is mounted to the
measuring device 1 and the blood of the living subject as the
sample liquid is deposited, but it is not limited in the all the
embodiments.
[0168] Blood, urine, interstitial fluid, or the like which is
practically a sample, in a form of liquid concentrate or liquid
solution, from a living subject is applied as the sample liquid.
Alternatively, it is fine to be products of experiment or products
of pseudo of those samples. Further, a process solution after
preprocess of degeneration and a chemical change be used.
Alternatively, in a case in which a control liquid for correcting
the measuring device 1 is used, the present invention is
applicable.
[0169] For the measuring object such as sugar group, lactic acid,
various cholesterols, nucleic acid, DNA, immune body, antigen,
protein, hormone, bacteria, enzyme, drug, antibiotic, medical
composition, marker, chemical substance, the present invention is
applicable for all that develop and determine quantity in the
sample.
[0170] The biosensor 7 having a structure such as a chamber storing
the sample which has been deposited and expanding by a function of
membrane or flow passage after the blood is deposited is used.
Alternatively, instead of the biosensor 7, a biochip or DNA chip
which is used in the preprocessing such as hybridization, blood
cell contraction, or blood cell breakage, can be used. In other
words, the present invention is applied to all configurations in
which there is a chance that the result of measuring is affected by
the movement or the posture of the sensor or the chip from
supplying the sample liquid to the sensor or the chip to the end of
measuring.
[0171] Further, a supply method for supplying the sample liquid to
the biosensor 7 is fine by supplying not only directly from the
living subject for the deposition but also from a syringe, a
cartridge, or a preprocessing reservoir. It is fine to measure the
object in a state in which the cartridge or the preprocessing
reservoir for supplying the sample liquid is mounted to the
biosensor 7.
[0172] Further, measuring by the measuring device 1 includes all
measuring method which can perform by the hand-held type measuring
device such as an optical type or a magnetic type.
[0173] The entire contents of Japanese Patent Application No.
2011-283197 (filing date: Dec. 26, 2011) is herein
incorporated.
[0174] The above mentioned embodiment is an example of the present
invention. For this reason, needless to say, the present invention
is not limited to the above mentioned embodiments, and various
modifications, although for a different embodiment, can be made
depending on designs, as long as the modifications do not deviate
from technical ideas of the present invention.
INDUSTRIAL APPLICABILITY
[0175] According to the above mentioned liquid sample measuring
system and the measuring device, when measuring the biological
information from the liquid sample of the living subject, it is
possible to confirm whether or not the handling of the user is
outside the allowable range, and to display the appropriate
countermeasure. The above mentioned liquid sample measuring system
is useful as a measuring administration incorporation system, or
the like, which includes a measuring device and a computer with an
administration program thereon.
* * * * *