CN100563563C - Body fluid composition measuring apparatus - Google Patents
Body fluid composition measuring apparatus Download PDFInfo
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- CN100563563C CN100563563C CNB2006100997330A CN200610099733A CN100563563C CN 100563563 C CN100563563 C CN 100563563C CN B2006100997330 A CNB2006100997330 A CN B2006100997330A CN 200610099733 A CN200610099733 A CN 200610099733A CN 100563563 C CN100563563 C CN 100563563C
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Abstract
The present invention relates to correctly to measure at short notice the body fluid composition measuring apparatus of the given composition in the body fluid, comprising: the stopper section that the epidermal patch of puncture is leaned on; Be used to keep the spatial accommodation of perforator; Drive puncture needle, abut in the puncture mechanism of the epidermis on the described stopper section with puncture; The epidermis site of puncture that makes puncture needle is with the spatial accommodation of the perforator mechanism of decompressor for decompression state; Be used for measuring from the mensuration mechanism of the amount of the given composition of the body fluid collection of described site of puncture, that scatter at described reagent paper; Be used to detect the biological fluid extracting testing agency of the collection of body fluid; Reach releasing or relax the decompression cancel system of the decompression state of the spatial accommodation of reagent paper at least, and adopt such formation: when detecting the collection of described body fluid by described biological fluid extracting testing agency, remove or relax the decompression state of the spatial accommodation of reagent paper at least by the decompression cancel system, afterwards, measure the amount of given composition in the body fluid of described collection by determinator.
Description
The application divides an application, and the application number of female case is 01816352.1, and the applying date of female case is July 26 calendar year 2001, and the denomination of invention of female case is a body fluid composition measuring apparatus.
Technical field
The present invention relates to body fluid composition measuring apparatus, particularly, use the lancet puncture epidermis, gather blood and measure the body fluid composition measuring apparatus of amount of the special component of for example glucose and so in this blood about when the detection of blood.
Background technology
In recent years, along with the increase of diabetics, recommend the self-blood-sugar level measuring method of the daily blood glucose value change of patient oneself monitoring.
The mensuration of this blood glucose value is to use the blood sugar detection device, this blood sugar detection device is equipped with the reagent paper according to the colour developing of the glucose amount in the blood, with this reagent paper of blood supply, makes it scatter on reagent paper, develop the color, measure the degree of (colour examining) this colour developing photographically, make the blood glucose value quantification.
Before measuring, the method as patient oneself gathers blood after the skin with the puncture mechanism puncture epidermis that has puncture needle or pocket knife, waits this site of puncture periphery of compressing with finger, extrudes blood.
Finger tip is the place that blood capillary is concentrated, be suitable for the collection of blood, but on the contrary, also be neural place of concentrating, can be accompanied by the generation of pain, misery, the burden brought to the patient are also bigger, and, the fear that also puncture is arranged and brought is so the patient can not oneself carry out the mensuration of blood glucose continuously mostly.
In addition, in blood sugar detection in the past, owing to puncture procedure, blood collection operation and measurement operation are carried out respectively, so operability is also bad.
As the device that addresses the above problem, known have puncture mechanism and determinator integratedly, and is provided with the blood sugar detection device (special be willing to flat 10-183794 number, specially be willing to flat 10-330057 number) of the attraction mechanism that is used to extrude blood.
Utilize this blood sugar detection device, at first, allow finger tip be pressed against the front end of perforator, this front opening is kept hermetic sealing.
Then, use the lancet puncture finger tip that stretches out from this front opening after, under this state, drive and attract mechanism (becoming decompression state), from site of puncture sucking-off blood, gather this blood.Then, measure the blood glucose value of the blood of being gathered by determinator.
Yet, utilize this blood sugar detection device, owing under certain pressure, attract blood, so, obtain the needed blood flow volume of blood-sugar level measuring and will spend the long time.
In addition, because the positions of the finger that presses etc. make between this finger and the perforator front end gapped, attract mechanism to reduce pressure fully even drive, therefore, can not obtain the needed blood flow volume of blood-sugar level measuring, obtain the adequate blood amount just must the long time of cost.
Moreover, show below when measuring blood glucose value, the glucose in the blood (
D-Glucose) with an example of the chemical equation of reagent, can judge from following chemical equation, the mensuration of blood glucose value needs the oxygen of q.s, if this oxygen amount is insufficient, just can not obtain correct blood glucose value.
But, utilize above-mentioned blood sugar detection device in the past, be under the original state of decompression state, to measure blood glucose value, in this case, hypoxgia is so might can not get correct blood glucose value.
Therefore, the present inventor had proposed before measuring in order to address the above problem, and by removing or relaxing the scheme that decompression state is fully supplied with oxygen (measuring the composition in the needed atmosphere), had finished the present invention.
The objective of the invention is, provide a kind of can be at short notice correctly and carry out the body fluid composition measuring apparatus of the mensuration of given composition in the blood reliably.
Summary of the invention
Above-mentioned purpose is finished by following first mode of the present invention (1)～(10).
(1) a kind of body fluid composition measuring apparatus is to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle and reagent paper,
Above-mentioned perforator with above-mentioned puncture needle and reagent paper also has housing, and above-mentioned reagent paper is configured in the peripheral part of above-mentioned housing, has the contact site that contacts with the epidermis of site of puncture at the front end of above-mentioned housing, has opening in the inboard of above-mentioned housing;
Above-mentioned body fluid composition measuring apparatus comprises:
The stopper section that the epidermal patch of puncture is leaned on;
Be used to keep the spatial accommodation of above-mentioned perforator;
Drive described puncture needle, abut in the puncture mechanism of the epidermis on the described stopper section with puncture;
The epidermis site of puncture that makes described puncture needle is with the spatial accommodation of the described perforator mechanism of decompressor for decompression state;
Be used for measuring from the mensuration mechanism of the amount of the given composition of the body fluid collection of described site of puncture, that scatter at described reagent paper;
Be used to detect the biological fluid extracting testing agency of the collection of described body fluid; And
The decompression cancel system of the decompression state of the spatial accommodation of releasing or the described at least reagent paper of mitigation,
And adopt such formation: when detecting the collection of described body fluid by described biological fluid extracting testing agency, remove or relax the decompression state of the spatial accommodation of described at least reagent paper by described decompression cancel system, afterwards, measure the amount of given composition in the body fluid of described collection by described mensuration mechanism.
(2), above-mentioned (1) record body fluid composition measuring apparatus, in said determination, need the given composition in the atmosphere.
(3), the body fluid composition measuring apparatus of above-mentioned (1) or (2) record, above-mentioned decompression cancel system has the valve that is communicated with above-mentioned spatial accommodation and outside stream and opens and closes this stream.
(4), the body fluid composition measuring apparatus of above-mentioned (1) or (2) record, above-mentioned decompression cancel system has and is communicated with above-mentioned spatial accommodation and outside stream, this stream its part at least has the bigger part of resistance ratios that air passes through.
(5), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (1)～(4), at least a portion of at least a portion of said determination mechanism and above-mentioned biological fluid extracting testing agency is mutual dual-purpose.
(6), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (1)～(5), above-mentioned body fluid composition measuring apparatus has the above-mentioned perforator of maintenance, is built-in with the housing of above-mentioned puncture mechanism,
The above-mentioned mechanism of decompressor makes the intravital above-mentioned spatial accommodation of above-mentioned shell become decompression state.
(7), the body fluid composition measuring apparatus of above-mentioned (6) record, the decompression state of the intravital above-mentioned spatial accommodation of above-mentioned shell is removed or relaxed to above-mentioned decompression cancel system.
(8), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (1)～(7), the driving of above-mentioned puncture mechanism and the driving of the above-mentioned mechanism of decompressor begin substantially simultaneously.
In this application, the invention of above-mentioned first mode also provides the invention (9) of the pressure detecting mechanism of regulation in (12) that comprise second mode described later and the mode of notifying operator or comprises the invention (10) of the mode with this two aspects device of pressure regulating mechanism of regulation in (25) of Third Way.
(9), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (1)～(8), also comprise: the pressure detecting mechanism that is used to detect the pressure of above-mentioned spatial accommodation; And be used to report the notifying operator of given information, to above-mentioned spatial accommodation examination decompression, above-mentioned notifying operator is according to reporting from the information of above-mentioned pressure detecting mechanism by the above-mentioned mechanism of decompressor.
Above-mentioned perforator has the stopper section that the epidermal patch that makes above-mentioned puncture is leaned on.
(10), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (1)～(9), also comprise the pressure regulating mechanism of the spatial accommodation pressure that is used to regulate puncture needle.
In addition, above-mentioned purpose is finished by (11)～(21) of following second mode of the present invention.
(11), body fluid composition measuring apparatus, be by the epidermis collection of body fluids and measure the body fluid composition measuring apparatus of this body fluid components, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
By making epidermal patch lean against on the above-mentioned stopper section and airtight airtightly space;
Making above-mentioned space is the mechanism of decompressor of decompression state;
Be determined at the amount of the given composition in the body fluid of gathering in the above-mentioned space and/or the mensuration mechanism of character;
Be used to detect the pressure detecting mechanism of above-mentioned space pressure; And
Be used to report the notifying operator of given information,
And adopt such formation: to the examination decompression of above-mentioned space, above-mentioned notifying operator is according to reporting from the information of above-mentioned pressure detecting mechanism by the above-mentioned mechanism of decompressor.
(12), body fluid composition measuring apparatus, be to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
Drive above-mentioned puncture needle, abut in the puncture mechanism of the epidermis on the above-mentioned stopper section with puncture;
Make the epidermis site of puncture of above-mentioned puncture needle and the spatial accommodation of above-mentioned puncture needle be the mechanism of decompressor of decompression state simultaneously;
Be used to detect the pressure detecting mechanism of above-mentioned spatial accommodation pressure;
Be used for measuring the mensuration mechanism of the amount of the given composition of gathering from above-mentioned site of puncture of body fluid; And
Be used to report the notifying operator of given information,
And adopt such formation: to above-mentioned spatial accommodation examination decompression, above-mentioned notifying operator is according to reporting from the information of above-mentioned pressure detecting mechanism by the above-mentioned mechanism of decompressor.
(13), body fluid composition measuring apparatus, be to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
Drive above-mentioned puncture needle, abut in the puncture mechanism of the epidermis on the above-mentioned stopper section with puncture;
Make the epidermis site of puncture of above-mentioned puncture needle and the spatial accommodation of above-mentioned puncture needle be the mechanism of decompressor of decompression state simultaneously;
Be used to detect the pressure detecting mechanism of above-mentioned spatial accommodation pressure;
Be used for measuring the mensuration mechanism of the amount of the given composition of gathering from above-mentioned site of puncture of body fluid; And
Be used to report the notifying operator of given information,
And adopt such formation: to above-mentioned spatial accommodation examination decompression, under the situation of the decompression state that does not detect above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, report the situation of error by above-mentioned notifying operator by the above-mentioned mechanism of decompressor.
(14), body fluid composition measuring apparatus, be to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
Drive above-mentioned puncture needle, abut in the puncture mechanism of the epidermis on the above-mentioned stopper section with puncture;
Make the epidermis site of puncture of above-mentioned puncture needle and the spatial accommodation of above-mentioned puncture needle be the mechanism of decompressor of decompression state simultaneously;
Be used to detect the pressure detecting mechanism of above-mentioned spatial accommodation pressure;
Be used for measuring the mensuration mechanism of the amount of the given composition of gathering from above-mentioned site of puncture of body fluid; And
Be used to report the notifying operator of given information,
And adopt such formation: above-mentioned spatial accommodation examination is reduced pressure by the above-mentioned mechanism of decompressor, under the situation of the decompression state that does not detect above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, report situation about will revise the epidermis position that reclines with above-mentioned stopper section by above-mentioned notifying operator, simultaneously, when preset time, above-mentioned pressure detecting mechanism did not detect the decompression state of above-mentioned spatial accommodation yet by process, report the situation of error by above-mentioned notifying operator.
(15), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (12)～(14), adopted under the situation of the decompression state that detects above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, drive the formation of above-mentioned puncture needle by above-mentioned puncture mechanism.
(16), body fluid composition measuring apparatus, be to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
Drive above-mentioned puncture needle, abut in the puncture mechanism of the epidermis on the above-mentioned stopper section with puncture;
Make the epidermis site of puncture of above-mentioned puncture needle and the spatial accommodation of above-mentioned puncture needle be the mechanism of decompressor of decompression state simultaneously;
Be used to detect the pressure detecting mechanism of above-mentioned spatial accommodation pressure; And
Be used for measuring the mensuration mechanism of the amount of the given composition of gathering from above-mentioned site of puncture of body fluid,
And adopt such formation: to above-mentioned spatial accommodation examination decompression, under the situation of the decompression state that detects above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, drive above-mentioned puncture needle by above-mentioned puncture mechanism by the above-mentioned mechanism of decompressor.
(17), the body fluid composition measuring apparatus of above-mentioned (15) or (16) record, also comprise having the drive source that electric means drives, by this drive source drives, the driving that begins the driving of above-mentioned puncture mechanism begins mechanism,
Under the situation of the decompression state that detects above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, begin the driving that mechanism begins above-mentioned puncture mechanism by above-mentioned driving, and drive above-mentioned puncture needle by this puncture mechanism.
(18), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (12)～(16), above-mentioned puncture mechanism has plunger and to the above-mentioned plunger force application part of the extreme direction application of force forward.
(19), the body fluid composition measuring apparatus of above-mentioned (18) record, above-mentioned plunger has and limits its extreme direction holding section of moving forward, and by the above-mentioned force application part application of force state under, remove the engaging of above-mentioned holding section, make this plunger forward extreme direction move, carry out the puncture of above-mentioned puncture needle.
(20), the body fluid composition measuring apparatus of above-mentioned (19) record, also comprise having the drive source that electric means drives, by this drive source drives, the driving of removing the engaging of above-mentioned holding section begins mechanism,
Under the situation of the decompression state that detects above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, begin the engaging that mechanism removes above-mentioned holding section by above-mentioned driving.
(21), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (12)～(20), under the situation of the decompression state that detects above-mentioned spatial accommodation by above-mentioned pressure detecting mechanism, once remove above-mentioned decompression state, afterwards, carry out above-mentioned puncture, and, make the finger site of puncture of above-mentioned puncture needle and the spatial accommodation of above-mentioned puncture needle become decompression state simultaneously by the above-mentioned mechanism of decompressor.
(22), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (12)～(21), above-mentioned body fluid composition measuring apparatus has the housing that keeps above-mentioned perforator, is built-in with above-mentioned puncture mechanism,
The above-mentioned mechanism of decompressor makes the intravital above-mentioned spatial accommodation of above-mentioned shell become decompression state.
(23), the body fluid composition measuring apparatus of above-mentioned (22) record, above-mentioned pressure detecting mechanism is used to detect the pressure of the intravital above-mentioned spatial accommodation of above-mentioned shell.
Above-mentioned purpose is also finished by (24)～(32) of following Third Way of the present invention.
(24), body fluid composition measuring apparatus, be by the epidermis collection of body fluids and measure the body fluid composition measuring apparatus of this body fluid components, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
By making epidermal patch lean against on the above-mentioned stopper section and airtight airtightly space;
Regulate the pressure regulating mechanism of above-mentioned space pressure; And
Be determined at the amount of the given composition in the body fluid of gathering in the above-mentioned space and/or the mensuration mechanism of character,
And adopt such formation: when in above-mentioned space, passing through the epidermis collection of body fluids, by above-mentioned pressure regulating mechanism reduced pressure in above-mentioned space, and this pressure is changed in time.
(25), body fluid composition measuring apparatus, be to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle, comprising:
The stopper section that the epidermal patch of puncture is leaned on;
Drive above-mentioned puncture needle, abut in the puncture mechanism of the epidermis on the above-mentioned stopper section with puncture;
Regulate the pressure regulating mechanism of the spatial accommodation pressure of above-mentioned puncture needle; And
The mensuration mechanism of the amount of the given composition of mensuration from the body fluid that above-mentioned site of puncture is gathered,
And adopt such formation: during from above-mentioned site of puncture collection of body fluids, above-mentioned spatial accommodation is reduced pressure, and this pressure is changed in time by above-mentioned pressure regulating mechanism.
(26), the body fluid composition measuring apparatus of above-mentioned (25) record, also adopt such formation: pressure detecting mechanism with the pressure that is used to detect above-mentioned spatial accommodation, by above-mentioned pressure regulating mechanism, the pressure of above-mentioned spatial accommodation is regulated based on information from this pressure detecting mechanism.
(27), the body fluid composition measuring apparatus of above-mentioned (25) or (26) record, when gathering above-mentioned body fluid, the pressure of above-mentioned spatial accommodation is alternately switched to subatmospheric first pressure and be higher than second pressure of this first pressure by above-mentioned pressure regulating mechanism.
(28), above-mentioned (27) record body fluid composition measuring apparatus, above-mentioned second pressure is atmospheric pressure or is lower than atmospheric pressure.
(29), above-mentioned (27) or (28) record body fluid composition measuring apparatus, the difference of above-mentioned second pressure and above-mentioned first pressure is 100～600mmHg.
(30), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (27)～(29), the cycle of above-mentioned pressure oscillation is 1～30sec.
(31), the body fluid composition measuring apparatus of above-mentioned (25) or (26) record, when gathering above-mentioned body fluid, at least have once by above-mentioned pressure regulating mechanism the pressure of above-mentioned spatial accommodation is once become subatmospheric first pressure, increase the circulation of above-mentioned pressure afterwards lentamente.
(32), the body fluid composition measuring apparatus of the arbitrary record in above-mentioned (27)～(31), above-mentioned first pressure is 100～600mmHg.
Above-mentioned first to Third Way,
(33), the body fluid composition measuring apparatus of above-mentioned (1)～(8), (14)～(23), the arbitrary record in (25)～(32), above-mentioned perforator has the stopper section that the epidermal patch of the puncture of making is leaned on.
(34), the body fluid composition measuring apparatus of above-mentioned (1)～(8), (14)～(23), the arbitrary record in (25)～(33), above-mentioned perforator has reagent paper and with the blood access of this reagent paper of blood supply.
(35), above-mentioned (34) record body fluid composition measuring apparatus, above-mentioned reagent paper is the reagent paper that blood sugar detection is used.
Brief description of drawings
Fig. 1 is the perspective view of first form of implementation of pattern ground expression body fluid composition measuring apparatus of the present invention.
Fig. 2 is the skiagraph of expression perforator configuration example used in the present invention.
Fig. 3 is the expression puncture mechanism that had of the first form of implementation body fluid composition measuring apparatus and the skiagraph that is built-in with the housing configuration example of puncture mechanism (perforator be installed in the housing before state).
Fig. 4 is the puncture mechanism that is had of the expression first form of implementation body fluid composition measuring apparatus and the skiagraph (perforator is installed to the state in the housing) that is built-in with the housing configuration example of puncture mechanism.
Fig. 5 is the skiagraph (state before puncture mechanism drives) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Fig. 6 is the skiagraph (state when puncture mechanism drives) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Fig. 7 is the skiagraph (state the when mechanism of decompressor drives) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Fig. 8 is the skiagraph (state when perforator is kept out of the way mechanism's driving) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Fig. 9 is the skiagraph (state when the decompression cancel system drives) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Figure 10 is the skiagraph (end-state) of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus.
Figure 11 is the block diagram that the loop of the expression first form of implementation body fluid composition measuring apparatus constitutes.
Figure 12 is the flow chart of control action (comprising a part, operator's action etc.) of the controlling organization of the expression first form of implementation body fluid composition measuring apparatus.
Figure 13 is the skiagraph of major part of second form of implementation of expression body fluid composition measuring apparatus of the present invention.
Figure 14 is the block diagram that the loop of the expression second form of implementation body fluid composition measuring apparatus constitutes.
Figure 15 is the puncture mechanism that had of the first form of implementation body fluid composition measuring apparatus of expression the present invention second mode and the skiagraph that is built-in with the housing configuration example of puncture mechanism (perforator be installed in the housing before state).
Figure 16 is the puncture mechanism that had of the first form of implementation body fluid composition measuring apparatus of expression the present invention second mode and the skiagraph (perforator is installed to the state in the housing) that is built-in with the housing configuration example of puncture mechanism.
Figure 17 represents the skiagraph state of the mechanism of decompressor when driving () of major part configuration example of the first form of implementation body fluid composition measuring apparatus of the present invention's second mode.
Figure 18 is the skiagraph (state when puncture mechanism drives) of major part configuration example of the first form of implementation body fluid composition measuring apparatus of expression the present invention second mode.
Figure 19 is the block diagram that the loop of the first form of implementation body fluid composition measuring apparatus of expression the present invention second mode constitutes.
Figure 20 is the flow chart of control action of controlling organization of the first form of implementation body fluid composition measuring apparatus of expression the present invention second mode.
Figure 21 is the flow chart of control action of controlling organization of second form of implementation of expression the present invention second mode.
Figure 22 is the flow chart of control action of controlling organization of the 3rd form of implementation of expression the present invention second mode.
The curve chart of the pressure pattern when Figure 23 is the collection blood of expression the present invention second mode in the spatial accommodation (inner cavity 52) of puncture needle.
Figure 24 is the curve chart of the pressure pattern in the spatial accommodation (inner cavity 52) of the present invention of expression the present invention second mode puncture needle when gathering blood.
Figure 25 is the perspective view of body fluid composition measuring apparatus first form of implementation of pattern ground expression Third Way of the present invention.
Figure 26 is the puncture mechanism that had of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention and the skiagraph that is built-in with the housing configuration example of puncture mechanism (perforator be installed in the housing before state).
Figure 27 is the puncture mechanism that had of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention and the skiagraph (perforator is installed to the state in the housing) that is built-in with the housing configuration example of puncture mechanism.
Figure 28 is the skiagraph (state before pressure regulating mechanism and puncture mechanism drive) of major part configuration example of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention.
Figure 29 is the skiagraph (state when puncture mechanism drives) of major part configuration example of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention.
Figure 30 be expression Third Way of the present invention the first form of implementation body fluid composition measuring apparatus the major part configuration example skiagraph (puncture back and the pressure regulating mechanism action time state).
Figure 31 is the skiagraph (end-state) of major part configuration example of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention.
Figure 32 is the flow chart of controlling organization control action of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention.
Figure 33 is the curve chart of the pressure pattern in the spatial accommodation (inner cavity 52) of the first form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention puncture needle when gathering blood.
Figure 34 is the skiagraph of major part of body fluid composition measuring apparatus second form of implementation of expression Third Way of the present invention.
Figure 35 is the curve chart of the pressure pattern in the spatial accommodation (inner cavity 52) of the second form of implementation body fluid composition measuring apparatus of expression Third Way of the present invention puncture needle when gathering blood.
The optimised form that carries out an invention
Body fluid composition measuring apparatus of the present invention is by epidermis (skin) collection of body fluids, measures the device of the given composition of this body fluid.
The position relevant (being the site of puncture in this form of implementation) with the above-mentioned biological fluid extracting of epidermis, preferably the finger, still, other positions for example the back of the hand, palm, hands sidepiece, wrist, thigh etc. also are feasible.
Hereinafter, be that the body fluid composition measuring apparatus (blood sugar detection device) of form of situation, puncture finger tip (finger) epidermis of blood describes for representative with body fluid.
Below, the best form of implementation shown in describes body fluid composition measuring apparatus of the present invention in detail with reference to the accompanying drawings.
Fig. 1 is the perspective view of body fluid composition measuring apparatus first form of implementation of pattern ground expression the present invention first mode, Fig. 2 is the skiagraph of expression perforator configuration example used in the present invention, Fig. 3 and Fig. 4 are respectively the skiagraphs of representing the puncture mechanism that the first form of implementation body fluid composition measuring apparatus is had and being built-in with the housing configuration example of puncture mechanism, Fig. 5～Figure 10 is respectively the skiagraph of the major part configuration example of the expression first form of implementation body fluid composition measuring apparatus, Figure 11 is the block diagram that the loop of the expression first form of implementation body fluid composition measuring apparatus constitutes, and Figure 12 is that the control action of the controlling organization of the expression first form of implementation body fluid composition measuring apparatus (comprises a part, operator's action etc.) flow chart.In addition, in Fig. 1～Figure 10, be that " cardinal extremity ", left side describe for " front end " with the right side of relative paper.
As Fig. 1, Fig. 5 and shown in Figure 11, the body fluid composition measuring apparatus of first form of implementation (blood constituent determinator) 1 comprises: body 2; Be arranged on the stopper section 3 on the body 2; Be contained in the puncture mechanism 4 in the housing 5; The perforator that is arranged on housing 5 base end sides is kept out of the way mechanism 6; The mensuration mechanism 7 of given composition in the collection of detection blood and the blood that mensuration is gathered; Make the pump 8 that becomes decompression state in the housing 5; Remove, relax or keep the electromagnetic valve 26 of the decompression state in the housing 5; Battery (power supply) 9; Be arranged on controlling organization 11 and display part 12 on the printed circuit board (PCB) 10.
This body fluid composition measuring apparatus 1 is installed perforator 13 back and is used, and in the chemical reaction during given composition in measuring blood, needs the given composition (for example oxygen, carbon dioxide, steam etc.) in the atmosphere.Each element hereinafter is described.
In the wall portion 211 of framework 21 front, be formed with transverse shape inside and outside the perforation framework 21 and be circular opening 212.By this opening 212 perforator 13 described later is installed (maintenance) in housing 5.
In addition, on the face of the front of wall portion 211, the periphery around opening 212 is provided with and the corresponding formed stopper section 3 of finger tip (finger) shape.Front in this stopper section 3 forms finger stop surface 31.Finger tip is contacted, Yi Bian drive body fluid composition measuring apparatus 1 with this stopper section 3 (finger stop surface 31).
Whereby, the epidermis of puncture finger is measured the amount of given composition in the blood of gathering (below, in this form of implementation, be that representative describes with the glucose).
Utilize this blood sugar detection device, at first, finger tip is pressed against on the perforator front end, this front opening 212 is sealed, make it keep air-tightness.
Then, use the lancet puncture finger tip that stretches out from front opening 212 after, in this state, drive and attract mechanism (becoming decompression state), from site of puncture sucking-off blood, gather this blood, then, measure the blood glucose value of the blood of gathering with determinator.
Display window (opening) 221 on lid 22 inside and outside the formation perforation lid 22, this display window is covered by the plate-shaped member that transparent material constitutes.
Be provided with display part 12 corresponding to the position in the spatial accommodation 23 of this display window 221.Therefore, can confirm the various information that show by display part 12 by display window 221.
In addition, on lid 22, be provided with action button 222.The formation of body fluid composition measuring apparatus 1 is by pushing this action button 222, to drive the pump (mechanism of decompressor) 8 that is connected with aftermentioned puncture mechanism 4 in turn or substantially simultaneously.
In addition, also can be to connect the structure of the power supply of body fluid composition measuring apparatus 1 by pushing this action button 222.
Downside in Fig. 1 of display part 12 is provided with printed circuit board (PCB) 10, is equipped with the controlling organization 11 that is made of microcomputer on this printed circuit board (PCB) 10.The exercises of these controlling organization 11 control examples such as blood collection whether body fluid composition measuring apparatus such as judgement 1.In addition, this controlling organization 11 is built-in with according to the calculation portion of calculating the glucose amount (blood glucose value) in the blood from the signal of measuring mechanism 7.
The lower-left side is provided with the pump 8 as the mechanism of decompressor (attracting mechanism) in Fig. 1 of printed circuit board (PCB) 10.This pump 8 is with power-actuated, is connected with pipe 81 by the vent path 54 that forms on the housing 5 described later.This pipe 81 has flexible, is made of macromolecular materials such as for example polrvinyl chloride, polyethylene, polypropylene, ethene-vinyl acetate copolymer polyolefin such as (EVA), polyamide, polyester, silicone rubber, polyurethanes.
This pump 8 makes the inner cavity 52 of housing 5 become decompression state by the air in the inner cavity 52 that attracts, discharges housing 5.
In addition, pump 8 also can make the inner cavity 52 of housing 5 and the site of puncture of finger become decompression state under the degree (for example, 100～400mmHg degree) of finger site of puncture sucking-off blood.
Lower right side in Fig. 1 of printed circuit board (PCB) 10 is provided with the battery 9 as power supply.This battery 9 is electrically connected with pump 8, electromagnetic valve 26, controlling organization 11, display part 12 etc., supplies with these parts and drives needed electric power.
Positive front side in Fig. 1 of pump 8 is equipped with measures mechanism 7.The supply (collection) of the reagent paper 18 that blood has to perforator 13 described later detects in this mensuration mechanism 7 with optical mode, simultaneously, be determined at the glucose amount in the blood that scatters on the reagent paper 18 with optical mode, its be provided with the position is perforator 13 install, remain on reagent paper 18 positions one side under the state in the housing 5 near.
So, measure mechanism 7 and have the function of the collection that detects blood and the function that is determined at the amount of glucose in the blood that scatters on the reagent paper 18 (given composition) concurrently, therefore, compare with the situation that this device is set respectively in each position, can reduce component number, simplify formation, and then reduce the assembling procedure of device.
This mensuration mechanism 7 has light-emitting component (light emitting diode) 71 and photo detector (photodiode) 72.
Light-emitting component 71 is electrically connected with controlling organization 11, and photo detector 72 is electrically connected with controlling organization 11 by amplifier 24 and A/D changer 25.
Light-emitting component 71 drives by the signal from controlling organization 11 and luminous.This light is preferably with the intermittently luminous pulsed light of given interval.
Under the state that perforator 13 is installed in the housing 5, if make light-emitting component 71 luminous, the rayed reagent paper 18 that sends from light-emitting component 71 then, its reflected light is subjected to light by photo detector 72, carry out opto-electronic conversion, from photo detector 72 outputs and this light income corresponding simulating signal, after this signal zooms into the signal of hope by amplifier 24, be transformed into digital signal by A/D changer 25, input to controlling organization 11.
Controlling organization 11 judges whether gather blood, promptly judge blood whether scattering on the reagent paper 18 of perforator 13 according to the signal of input.
Controlling organization 11 carries out given calculation process according to the signal of input, in addition, carries out revisal as required and calculates, and obtains the glucose amount (blood glucose value) in the blood, and the blood glucose value of obtaining is shown by display part 12.
Positive front side in the Fig. 1 that measures mechanism 7 is provided with housing 5 and keeps out of the way mechanism 6 with the perforator that is connected the base end side that places housing 5, is built-in with puncture mechanism 4 in the housing 5.
Perforator is kept out of the way mechanism 6 and is fixed on the framework 21, and on the other hand, housing 5 is not fixed on the framework 21, is being provided with movably along its axial (left and right directions among Fig. 1) but keep out of the way mechanism 6 by perforator.
As indicated above, this body fluid composition measuring apparatus 1 is installed to perforator 13 in the housing 5 and uses.Perforator 13 as shown in Figure 2, by puncture needle 14, hold first housing 15 of puncture needle 14, second housing 16 that is arranged on first housing, 15 peripheral parts, the reagent paper fixed part 17 that is arranged on second housing, 16 peripheral parts, the reagent paper 18 that is fixed on the reagent paper fixed part 17 slidably and constitute.
Puncture needle 14 is made of needle body 141, the handle 142 that is fixed on needle body 141 base end sides, and is contained in the inner cavity 152 of first housing 15.
Hollow part or solid parts that needle body 141 is made by for example metal materials such as rustless steel, aluminum, aluminium alloy, titanium, titanium alloy constitute, and its front end forms sharp keen blade tip (needle point), by means of the epidermis (skin) of this blade tip puncture finger tip.
In addition, handle 142 roughly is made of columnar component, and its peripheral part contacts with the inner peripheral surface of first housing 15 and slides.
Form the reducing diameter part 143 of undergauge at the base end part of handle 142.The punch block 411 of the plunger 41 of this reducing diameter part 143 and formation described later puncture mechanism 4 is chimeric.
It is circular hole 154 that the substantial middle portion of wall portion 153 forms transverse shape.Pass through this hole 154 during the epidermis of needle body 141 puncture finger tips (finger).In addition, the external diameter less than handle 142 front ends is set in the aperture in this hole 154 for.Therefore, in case puncture needle 14 moves to the preceding extreme direction of inner cavity 152, when the front end of handle 142 is contacted with the cardinal extremity of wall portion 153, can prevent that puncture needle 14 forward end directions from moving excessively.Therefore, during needle body 141 puncture finger tips, the length outstanding from perforator 13 front ends remains necessarily.Thereby the blade tip that can prevent needle body 141 reliably excessively, puncture too deeply.
In addition, be provided with the mechanism that is used to regulate plunger 41 displacements described later, thus, also can regulate the paracentesis depth of the blade tip of needle body 141 finger tip.
Fixing second housing 16 at the peripheral part of first housing 15.
Front end at second housing 16 is formed with the outstanding abutment 163 of ring-type.This abutment 163 is positions (being the stopper section) that finger tip presses, and its inboard is formed with and makes inner cavity 161 open front end openings (opening) 162.The shape of the front end outer peripheral edges of abutment 163 is made: the effect of the pain in the time of relaxing the peripheral irriate of puncture, puncture when being suitable for bringing into play finger tip and pressing; In addition, also make such shape: when becoming decompression state, can suppress air as possible from the front end of abutment 163 and the inflow between the finger tip surface by pump 8.In addition, can abutment 163 be set yet, but the front end face of second housing 16 is made tabular surface at the front end of second housing 16.
On second housing 16, near the peripheral part the cardinal extremity of abutment 163 forms outstanding laterally collar flange 164.Under the state of this collar flange 164 in being installed on housing 5 described later, the preceding end in contact of its cardinal extremity and housing 5, the position of stipulating relative housing 5.
Peripheral part at second housing 16 forms recess 165, and the reagent paper fixed part 17 that is used to be provided with discoid reagent paper 18 is installed on this recess 165.
In addition, on the inner peripheral surface of second housing 16, form to inner cavity 161 outstanding blood and import guiding parts 166.This blood imports guiding parts 166 and has the function of accepting to flow into from front opening 162 blood (corpse or other object for laboratory examination and chemical testing) of inner cavity 161 behind the puncture finger tip.
In this perforator 13, form the inner cavity 161 and outside blood access 19 that are communicated with second housing 16 through second housing 16, reagent paper fixed part 17.This blood access 19 is blood that puncture is obtained streams to reagent paper 18 guiding, has passage opening 191 that opens wide to inner cavity 161 and the passage opening 192 that opens wide to the outside of perforator 13.In addition, passage opening 192 is positioned at the central part of reagent paper 18.
Blood imports guiding parts 166 and forms near passage opening 191.Therefore, will import the blood that guiding parts 166 accepts by blood more effectively is directed to the blood access 19 from passage opening 191.This blood arrives passage opening 192 by capillarity, supplies with the central part of the reagent paper 18 that is provided with the form of closing passage opening 192, scatters with radial.
This reagent paper 18 is can absorb, maintain reagent on the carrier of the blood that scatters.As carrier can be the flake porous plastid of non-woven fabrics, fabric, prolonged treatment sheet material etc. for example.The best possess hydrophilic property of this porous plastid.
The reagent that remains on the carrier can suitably be determined according to the composition that will measure in the blood (corpse or other object for laboratory examination and chemical testing).For example, under the situation that blood-sugar level measuring is used, can be for example glucoseoxidase (GOD), peroxidase (POD) and for example developer (colour reagent) of 4-amino-antipyrine, N-ethyl-N-(2-hydroxyl-3-sulfo group propyl group)-m-toluidines and so on, in addition, according to measuring composition, also can be for example ascorbic acid oxidase, Alcohol oxidase, cholesterol oxidase etc. and the blood constituent reaction and with above-mentioned same developer (colour reagent).The buffer agent that can also comprise in addition, phosphate buffer and so on.Self-evident, kind, the composition of reagent are not limited to this.
This perforator 13 can freely be installed (chimeric) on housing 5 (fitting portion 53) by the opening 212 of above-mentioned framework 21 with loading and unloading.
Sidepiece at housing 5 forms communication with cavity portion 52 and outside vent path 54.This vent path 54 is connected with pump 8 by pipe 81.Air in the inner cavity 52 is attracted by vent path 54 and pipe 81 by pump 81, makes inner cavity 52 (containing in the perforator 13) become decompression state.
In addition, as shown in Figure 5, an end of pipe 82 is connected in the way of pipe 81, and the other end of pipe 82 opens wide towards the outside of body 21.This pipe 82 has flexible, by for example constituting with the same material of above-mentioned pipe 81.
In the way of pipe 82, be provided with the electromagnetic valve 26 of its stream of switching (opening/closing).
When closing electromagnetic valve 26 when state (closed), keep above-mentioned inner cavity 52 decompression state of (containing in the perforator 13), when opening electromagnetic valve 26 state of the unlatching (time), by pipe 82,81 and vent path 54, air (atmosphere) is imported in the inner cavity 52 of above-mentioned decompression state from the outside, remove or relax its decompression state.
Therefore, constitute the decompression cancel system by means of above-mentioned pipe (stream) 81,82 and electromagnetic valve 26.
As shown in Figures 3 and 4, in the wall portion 51 of housing 5, form hole 511 at its central part roughly.In this hole 511, be provided with the inner tubule 65 that forms throttle orifice (path) 651.Air can pass through this throttle orifice 651, flows through between inner cavity 52 that is provided with by tubule 65 both sides and the variable volume described later chamber 631.
Cyclic sealing ring (seal member) 55 arranged in that the front end of housing 5 is chimeric.Therefore, when being installed in perforator 13 in the housing 5, the cardinal extremity of the flange 164 of perforator 13 contacts with sealing ring 55, keeps the air-tightness of inner cavity 52.
Sealing ring 55 is made of elastomer.As elastomer can be various elastomeric materials of natural rubber, isoprene rubber, butadiene rubber, styrene butadiene ribber, eyeball base butadiene rubber, neoprene, buttress rubber, acrylic rubber, ethylene-propylene rubber, Carbicron rubber, polyurethane rubber, silicone rubber, fluorubber and so on for example, or various thermoplastic elastomers such as polystyrene, polyolefin, polyvinyl chloride, polyurethanes system, polyester system, polyamide-based, polybutadiene system, fluorubber system.
From the fitting portion 53 of this housing 5, mechanism 4 is contained in the inner cavity 52 of base end side with puncture.This puncture mechanism 4 moves mounted thereto puncture needle 14 forward end directions, the surface of the blade tip puncture finger tip by needle body 141.
Leading section at plunger 41 is provided with cup-shaped punch block 411.The reducing diameter part 143 of puncture needle 14 can be entrenched in this punch block 411 with freely loading and unloading.In addition, be provided with the flexure strip 412 of elastically deformable at the base end part of plunger 41, this flexure strip 412 is provided with the holding section 413 of convex shape at front end.
State before being installed to perforator 13 in the housing 5 promptly, under the state (with reference to Fig. 3) of puncture needle 14 before being installed in the plunger 41, holding section 413 is by means of the elastic force of flexure strip 412, be subjected to the effect of the elastic force of top in Fig. 3, contact with the inner peripheral surface of housing 5.On the other hand, perforator 13 is installed in the housing 5 state promptly, puncture needle 14 is installed under the state (with reference to Fig. 4) in the plunger 41, holding section 413 inserts that to connect housings 5 inside and outside and in the opening 57 that forms, engage with its edge portion.Whereby, the restriction plunger 41 forward extreme direction move.In addition, opening 57 is sealed by tabular seal member (seal member) 58, keeps the air-tightness of inner cavity 52.Sealing parts 58 are by constituting with the same material of above-mentioned sealing ring 55.
Helical spring (puncture spring) 42 is arranged on the base end side of plunger 41, and its two ends contact with plunger 41 and wall portion 51 respectively.On the other hand, helical spring (push back and use spring) 43 is arranged on the front of plunger 41, and its two ends contact with plunger 41 and fitting portion 53 respectively.
In addition, as shown in Figures 3 and 4,, be provided with and make holding section 413 (direction shown in the arrow in the figure) mobile engaging in inner cavity 52 remove parts 223 in the outside of housing 5.This engaging is removed parts 223 and is moved with pushing in linkage of aforesaid operations button 222.
Under holding section 413 and state that opening 57 engages, helical spring 42 is in compressive state, to the plunger 41 extreme direction application of force forward.Pressing operation button 222 makes engaging remove parts 223 direction shown in the arrow in the figure and moves, and during the fastening state of engagement release portion 413, helical spring 42 elongations are moved plunger 41 forward end directions, the surface (skin) of the blade tip puncture finger tip of needle body 141.
On the other hand, at this moment, helical spring 43 gives plunger 41 towards the proximal direction application of force by compression, that is to say, towards proximal direction pushing plunger 41.Afterwards, plunger 41 is made convergent mode of motion, and is static in the position of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.
Under plunger 41 immobilized states, the blade tip of needle body 141 places in the perforator 13.
Be provided with perforator at the base end side of housing 5 and keep out of the way mechanism 6.
Perforator is kept out of the way mechanism 6, and housing 5 and the perforator 13 that is installed in the housing 5 move towards the direction (proximal direction) of leaving finger tip 200.
This perforator is kept out of the way mechanism 6 as Fig. 5～shown in Figure 10, has body 61, sealing ring 64 and tubule 65.
Front end at body 61 is formed with to the outstanding annular convex 611 of its center position.Under the state before perforator is kept out of the way mechanism's 6 drivings, the preceding end in contact of the cardinal extremity of protuberance 611 and flange 56.Whereby, limit housing 5 moving of extreme direction forward.That is to say, can prevent that housing 5 from extracting from body 61.
In addition, at this moment, the front end of abutment 163 is positioned at and the roughly the same position of finger stop surface 31, perhaps from finger stop surface 31 outstanding (with reference to Fig. 5) a little.Whereby, when finger tip 200 contacted with stopper section 3, the surface energy of finger tip 200 contacted with abutment 163 reliably, and front opening 162 is sealed.
In wall portion 62, portion forms the recess 621 that transverse shape is a circle in the central.The diameter of this recess 621 be set at the external diameter of protuberance 59 about equally, protuberance 59 inserts in these recesses 621.In addition, the external diameter of flange 56 set for the internal diameter of body 61 about equally.Adopt this formation, the axial location of tube shell 5 is not how, can prevent the dislocation dislocation of the center of body 61 (housing 5 with) of above-below direction among the figure for example more reliably yet.
The periphery of protuberance 59 promptly is provided with annular seal ring 64 between the front end side 622 of the cardinal extremity of housing 5 and wall portion 62.Sealing ring 64 seals up the cardinal extremity and the face 622 of housing 5 separately airtightly.Whereby, in the zone that the inner surface of cardinal extremity, face 622 and the recess 621 of sealing ring 64, housing 5 surrounds, divide to form and has bubble-tight variable volume chamber (pressure-reducing chamber) 631.
In addition, sealing ring 64 is made of elastomer, keeps out of the way at perforator under the driving condition (state shown in Figure 8) of mechanism 6, by means of its elastic force, to the housing 5 extreme direction application of force forward.In other words, sealing ring 64 also has the function as force application mechanism.This elastomer can use and same material such as above-mentioned sealing ring 55 grades.
By regulating the diameter of throttle orifice 651, can regulate the driving of pump 8 and the time started that perforator is kept out of the way the driving of mechanism 6.
In addition, tubule 65 is not limited to illustrated structure, and it is provided with number can be as required for a plurality of.
Utilize such perforator to keep out of the way mechanism 6, when finger tip 200 contacts, is sealing under the state of front opening 162 driving pump 8 with abutment 163, at first, inner cavity 52 (comprising in the perforator 13) becomes decompression state, air in the variable volume chamber 631 flows in inner cavity 52 by throttle orifice 651, and the decompression of variable volume chamber 631 begins.Because the air of throttle orifice 651 is by the resistance height,, make housing 5 and the perforator 13 that is contained in the housing 5 moves gradually towards the direction of leaving finger tip 200 so the volume of variable volume chamber 631 reduces gradually.
Then, when the cardinal extremity 591 of protuberance 59 contacts with the bottom surface of recess 621, housing 5 and be contained in perforator 13 in the housing 5 towards mobile the stopping (with reference to Fig. 8) of proximal direction.Therefore, by regulating the axial length of protuberance 59, can prevent that perforator 13 from leaving finger tip 200 excessively.In other words, reach the bottom surface of the recess 621 of contact with it, constitute mechanism's (displacement is stipulated mechanism) that regulation perforator 13 leaves the displacement (maximum retreat distance) of finger tip 200 by means of protuberance 59.
There is no particular limitation for the distance (the maximum retreat distance of perforator 13) of leaving of this perforator 13 and finger tip 200, still, if adopt the degree of 0.2～2.5mm for example relatively good, the degree of 0.5～1.5mm preferably.Be taken in the above-mentioned scope by leaving distance, can be more reliable and in the shorter time, guarantee the adequate blood amount.In addition, can prevent reliably that also finger tip 200 from unclamping front opening 162.
In addition, perforator is kept out of the way mechanism 6 and is driven along with the driving of pump 8.That is, this perforator is kept out of the way mechanism 6 by 52 decompressions of 8 pairs of inner cavity of pump, after front opening 162 places absorption finger tip 200, makes perforator 13 keep out of the way (moving) to proximal direction gradually.Therefore, in the time of site of puncture 210 decompression states that perforator keeps out of the way that mechanism 6 can keep finger tip 200, make perforator 13 leave finger tip 200.
Such perforator is kept out of the way mechanism 6 and is utilized the decompression of pump 8 generations power-actuated.That is to say that also can think pump (mechanism of decompressor) the 8th, perforator is kept out of the way one of element of mechanism 6.
In addition, this perforator is kept out of the way mechanism 6 and is not needed to append other drive sources, therefore, is favourable for the reduction of miniaturization, lightweight and the manufacturing cost of body fluid composition measuring apparatus 1.
In addition, utilize this body fluid composition measuring apparatus 1, as shown in Figure 6, when finger tip 200 is pressed against on the stopper section 3, the preceding end in contact of the surface of finger tip 200 and abutment 163, oppress the blood capillary at the peripheral position of site of puncture 210 by means of the front end of this abutment 163, this site of puncture 210 that can keep finger tip 200 is decompression state, simultaneously, also can make perforator 13 leave finger tip 200, therefore, the blood capillary at peripheral position of site of puncture 210 of the front end compressing of abutment 163 be opened, can be more reliable and at short notice with blood 220 210 sucking-offs from the site of puncture, guarantee that glucose amount measures needed and adequate blood amount.
In addition, keep out of the way at perforator under the driving condition (state shown in Figure 8) of mechanism 6, housing 5 is moved to proximal direction, sealing ring 64 is in compressive state.As indicated above, because sealing ring 64 is made of elastomer, so, under state shown in Figure 8, to the housing 5 forward end direction application of forces.Whereby, open electromagnetic valve 26, when removing decompression state, sealing ring 64 returns original shape substantially under self elastic force effect, make housing 5 forward extreme direction move (with reference to Fig. 9, Figure 10).At this moment, the front end of the flange 56 of housing 5 contacts with the cardinal extremity of the protuberance 611 of body 61, thereby has limited undue move (with reference to Figure 10) of forward end direction.That is to say housing 5 and be installed in wherein perforator 13 and return perforator and keep out of the way position before mechanism 6 drives.
Below, with reference to Fig. 2～Figure 10 and flow chart shown in Figure 12, illustrate with body fluid composition measuring apparatus 1 puncture, the collection of blood, scatter and the situation of blood-sugar level measuring under the action of each several part and the control action of controlling organization.
(1) at first, in the fitting portion 53 of opening 212 by framework 21, make the reducing diameter part 143 and punch block 411 chimeric (with reference to Fig. 4) of puncture needle 14 with perforator 13 insertion housings 5.
Then, when proximal direction is pressed into perforator 13, overcome the elastic force of helical spring 42, plunger 41 is moved towards proximal direction.Holding section 413 contacts with the inner peripheral surface of inner cavity 52 by the elastic force application of force of flexure strip 412, still, when holding section 413 is in the position of opening 57, inserts in the opening 57 (with reference to Fig. 4).Thus, even remove the pushing force of the proximal direction of perforator 13, holding section 413 also engages with opening 57, and restriction plunger 41 is moving of extreme direction forward.At this moment, helical spring 42 is in compressive state.In this state, the preparation of the collection of the puncture preparation of end puncture mechanism 4 and blood (corpse or other object for laboratory examination and chemical testing).
(2) then, connect on and off switch not shown in the figures, thus, start the each several part of body fluid composition measuring apparatus 1, make it be in the state that to measure.In addition, close electromagnetic valve 26.
(3) secondly, finger tip (finger) 200 is pressed against on the stopper section 3.Thus, make finger tip 200 press the abutment 163 of perforator 13.At this moment, to reduce the mode of escape of air as far as possible, seal front opening 162 (with reference to Fig. 5) with finger tip 200.
(4) then, pressing operation aforesaid operations button 222, the surface (the step S1 of Figure 12) of puncture finger tip 200.
In case push button 222, the engaging that is connected with action button 222 are removed parts 223 will be towards following side shifting among Fig. 4.Whereby, engaging is removed parts 223 and is contacted with holding section 413, and holding section 413 is pushed back inner cavity 52 1 sides.Thus, the engaging of engagement release portion 413, under the elastic force effect of the helical spring 42 that compresses, plunger 41 forward end directions move, and needle body 141 is stretched out from front opening 162, the surface (with reference to Fig. 6) of puncture finger tip 200.Produce hemorrhage from the site of puncture 210 of needle body 141.
In addition, by pushing of aforesaid operations button 222, also connect the driving switch (not shown) of pump 8 substantially simultaneously.
(5) behind the needle body 141 puncture finger tips 200, helical spring 43 pushes plunger 41 towards proximal direction.Plunger 41 is through behind the convergent mode of motions, in the position static (with reference to Fig. 7) of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.At this moment, the blade tip of needle body 141 is contained in the perforator 13.So under the situation beyond when puncture, the blade tip of needle body 141 can not stretch out from front opening 162.Can eliminate the phenomenon of mistake with the skin equivalent damage, in addition, also can protect from infection, safety is good.
When (6) driving switch of said pump 8 is connected, controlling organization driving pump 8 (the step S2 of Figure 12).
In other words, with the operation of above-mentioned (4) driving pump 8 substantially side by side, the air in the inner cavity 52 of beginning housing 5 attract.Whereby, reduce inner cavity 52 pressure of (comprising in the perforator 13), make it be in decompression state.
At this moment, the site of puncture 210 of the needle body 141 of finger tip 200 also is in decompression state.But in this state, the finger tip 200 that is positioned at abutment 163 inboards (front opening 162) bloats to the inside of perforator 13, becomes the hills shape, the peripheral position in the site of puncture 210 that the front end with abutment 163 is abutted against, compressing blood capillary.
(7) further, during the attraction of the inner cavity 52 of continuation pump 8, the air in the variable volume chamber 631 flow out to inner cavity 52 gradually by throttle orifice 651, and the volume of variable volume chamber 631 is reduced gradually.Whereby, housing 5 and the perforator 13 that is mounted in it are to proximal direction, promptly begin gradually to move to the direction of leaving finger tip 200.
At this moment, owing to continue to keep the decompression state of the site of puncture 210 of inner cavity 52 and finger tip 200, so finger tip 200 can not unclamp from front opening 162.In addition, even perforator 13 moves towards the direction of leaving finger tip 200, finger tip 200 also contacts with stopper section 3, so, can be along with perforator 13 moves.Therefore, perforator 13 can leave finger tip 200 reliably.
Leave finger tip 200 by perforator 13, open gradually by the blood capillary at the peripheral position of the site of puncture 210 of this abutment 163 front ends compressing, can be from the site of puncture 210 sucking-off blood 220 (with reference to Fig. 8).In other words, compare, can promote hemorrhagely, guarantee needed blood flow volume at short notice with the situation that finger tip 200 and perforator 13 do not leave.
In addition, the minimum pressure that produces of this pump 8 degree of 100～400mmHg for example preferably.
Then, the cardinal extremity 591 of protuberance 59 contacts with the bottom surface of recess 621.Whereby, housing 5 and the perforator 13 that is mounted in it thereof stop towards the mobile of proximal direction.So, since perforator 13 can stop at apart from finger tip 200 suitably leave the distance between the place, so finger tip 200 can not unclamp from front opening 162.Thus, can prevent more reliably 210 sucking-offs from the site of puncture the dispersing of blood 220, to around pollution, improved safety.
As indicated above, utilize body fluid composition measuring apparatus 1, by once pushing of action button 222, the action of just can puncturing is substantially simultaneously moved with decompression, and in addition, the action of keeping out of the way of perforator 13 also is to utilize the decompression power of pump 8 to carry out, and, decompression described later is removed action and also can be begun automatically, so operability is very good.
(8) in the operation of above-mentioned (7), attracted in the perforator 13 with the granular blood 220 that on site of puncture 210, swells, importing guiding parts 166 with its inner blood that forms contacts, import reagent paper 18 by blood access 19, supply with the central part of reagent paper 18, with radial scattering (with reference to Fig. 2).
Along with the supply of blood 220 on reagent paper 18, scatter, the glucose in the blood 220 (composition that will measure) reacts with the reagent that remains on the reagent paper 18, reagent paper 18 develops the color according to glucose amount.
On the other hand, controlling organization 11 drive to be measured mechanism 7 after having implemented step S2 shown in Figure 12, measures the colour developing that mechanism 7 monitors (monitoring) reagent paper 18 by this, judges collection blood whether (the step S3 of Figure 12).
In step S3, when the voltage of signals value of importing from the photo detector 72 of determinator 7 surpasses predefined ultimate value, be judged as and gathered blood, when above-mentioned magnitude of voltage is lower than predefined ultimate value, is judged as and does not gather blood.
Above-mentioned ultimate value is set at: compare very greatly with the above-mentioned voltage of signals value before making reagent paper 18 colour developing, and the above-mentioned voltage of signals value during with colour developing is compared very little.
In above-mentioned steps S3, be judged as under the situation of not gathering blood, whether judgement time arrives (the step S4 of Figure 12).
In above-mentioned steps S4, under the situation about not arriving in the time of being judged as, return step S2, the later processing of implementation step S2 once again is being judged as under the situation that time is up, carries out Error processing (the step S5 of Figure 12).
In step S5, stop pump 8, open electromagnetic valve 26, remove above-mentioned decompression state, show the expression (error is represented) of this source of error of expression at display part 12.
Operator's (user) represents to hold the situation (any trouble) of error according to this error.
Effect when in addition, above-mentioned electromagnetic valve 26 is opened will be explained below.
In addition, in above-mentioned steps S3, be judged as under the situation of having gathered blood, stopping pump 8 (the step S6 of Figure 12).
Then, open electromagnetic valve 26, remove above-mentioned decompression state (the step S7 of Figure 12).
In case open electromagnetic valve 26, exogenous QI (atmosphere) will flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210 through pipe 82,81 and vent path 54, makes inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure (with reference to Fig. 9).
In addition, sealing ring 64 returns original shape substantially under the effect of self elastic force, make housing 5 forward extreme direction move (with reference to Fig. 9, Figure 10).At this moment, the front end of the flange 56 of housing 5 contacts with the cardinal extremity of the protuberance 611 of body 61, can limit undue move (with reference to Figure 10) of housing 5 forward end directions.
Eliminate, return atmospheric pressure if confirm as the attraction sense at peripheral position of the site of puncture 210 of finger tip 200, just make finger tip 200 leave the abutment 163 of perforator 13.
(9) after having implemented step S shown in Figure 12, controlling organization 11 is by measuring the colour developing degree that mechanism 7 measures above-mentioned reagent paper 18, according to the perform calculations revisals such as revisal calculating of processing, temperature revisal calculating, hematocrite value of resulting data, make blood glucose value quantification (the step S8 of Figure 12).
In this case, owing to removed inner cavity 52 decompression state of (comprising in the perforator 13), be the decompression state of the spatial accommodation of reagent paper 18, so, can supply with the glucose (composition that will measure) in the above-mentioned blood 220 fully and remain on composition in the needed atmosphere of reaction of reagent of reagent paper 18, thus, can more correctly measure blood glucose value.
Then, show above-mentioned blood glucose value of calculating (the step S9 of Figure 12) at display part 12.
Thus, can hold blood glucose value.
As indicated above, according to this body fluid composition measuring apparatus 1, can gather the blood of measuring needed and abundant amount at short notice reliably, simultaneously, can be correctly and measure blood glucose value (amount of the given composition in the blood) reliably.
In addition, owing in perforator 13, be provided with reagent paper 18, so the collection and the scattering, measuring on reagent paper 18 (quantification of composition) of puncture, blood can be carried out continuously, so, be easy to carry out at short notice the mensuration (composition measurement) of blood glucose value.
Be easy to carry out beamhouse operation in use, therefore, also more favourable for the situation of regular use or situation about using repeatedly.
The accident on live body surface etc. has improved safety in case can prevent to puncture once again mistakenly after the puncture.And, owing to can directly not see puncture needle 14, so, the fear when also having alleviated puncture.
From as can be seen above-mentioned, this body fluid composition measuring apparatus 1 is suitable for situation about using when patient oneself measures self blood glucose value etc.
In addition, this body fluid composition measuring apparatus 1 simple in structure, small-sized, light weight, cheap is so also be applicable to mass production.
Below, second form of implementation of the body fluid composition measuring apparatus of the present invention's first mode is described.The body fluid composition measuring apparatus of the body fluid composition measuring apparatus of this second form of implementation and above-mentioned first form of implementation different be the to reduce pressure formation of cancel system.
Figure 13 is the skiagraph of major part configuration example of the body fluid composition measuring apparatus of expression second form of implementation, and Figure 14 is the block diagram that the loop of the expression second form of implementation body fluid composition measuring apparatus constitutes.
Hereinafter, be that the center describes with difference with the body fluid composition measuring apparatus of above-mentioned first form of implementation, as for same item, it illustrates omission.In addition, in the following description, be " cardinal extremity " with the right side of Figure 13, the left side is " front end ".
As Figure 13 and shown in Figure 14, the second form of implementation body fluid composition measuring apparatus 1 is provided with tubule 83, replaces the electromagnetic valve 26 of the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
Tubule 83 is made of cylinder-like part, and its inside is formed with throttling (stream) 831.The engaged at end (connection) of this tubule 83 and pipe 82, the front end of tubule 83 (throttle orifice 831) opens wide towards the outside of body 21.
The throttle orifice 831 of this tubule 83 is made thin gauge structure, so the resistance ratios that air passes through is bigger.The diameter of this throttle orifice 831 is not particularly limited, still, and for example if the degree of 0.01～0.3mm is relatively good.In addition, also there is no particular limitation for the length of throttle orifice 831, still, if the degree of 5～15mm is relatively good.Be taken in the above-mentioned scope by diameter, can obtain the resistance of necessary sufficient air by (circulation) with throttle orifice 831.
Constitute the decompression cancel system by means of above-mentioned pipe (stream) 81,82 and tubule 83.
In addition, tubule 83 is not limited to illustrated structure, and its number that number or throttle orifice are set can be as required for a plurality of.
Below, with reference to flow chart shown in Figure 12, be the center with difference with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation, the action of this body fluid composition measuring apparatus 1 is described.
The body fluid composition measuring apparatus 1 of step S1 at first, shown in Figure 12～step S6 and above-mentioned first form of implementation is basic identical.
In this case, utilize this body fluid composition measuring apparatus 1, since the flow of the air that the driving of pump 8 attracts greater than (more than) flow of the exogenous QI (atmosphere) that flows into from the throttle orifice 831 of tubule 83, so, during driving pump 8, the attraction of the air in the inner cavity 52 of housing 5 begins, whereby in step S2, reduce inner cavity 52 pressure of (comprising in the perforator 13), make it be in decompression state.
Then, utilize this body fluid composition measuring apparatus 1, in a single day in step S6, pump 8 is stopped, exogenous QI will be through throttle orifice 831, pipe 82,81 and the vent path 54 of tubule 83, flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210, remove the decompression state (the step S7 of Figure 12) of inner cavity 52 (comprising in the perforator 13) and site of puncture 210.In other words, inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure.
Below, the body fluid composition measuring apparatus 1 of step S8 shown in Figure 12 and step S9 and above-mentioned first form of implementation is same.
According to this body fluid composition measuring apparatus 1, can obtain the effect same with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
More than, though based on illustrated each form of implementation the body fluid composition measuring apparatus of first mode of the present invention has been described,, the present invention is not limited to this, and for example the formation of each one can be replaced into the formation arbitrarily that can bring into play same function.
In addition, in above-mentioned form of implementation, as the composition of measuring purpose, though be to be that representative is illustrated with glucose (blood glucose value), but mensuration composition of the present invention is not limited to this, also can be inorganic ionss such as albumen, cholesterol, uric acid, creatine class amide, ethanol, sodium etc. for example.
In addition, in above-mentioned form of implementation, be also used as the blood collection testing agency of detecting blood collection and the mechanism that measures the mensuration mechanism of the amount of given composition in the blood (in form of implementation, this mechanism being called " measuring mechanism ") though be provided with, but, blood collection testing agency also can be set respectively in the present invention and measure mechanism.
In above-mentioned form of implementation, as blood collection testing agency, though what use is the mechanism of detecting blood collection with optical mode,, the present invention is not limited to this, also can use other the mechanism of for example detecting with electric means.
In addition, in the present invention, under the situation of the blood collection testing agency that uses the collection that detects blood with optical mode, be not limited to detect the colour developing (color development) of reagent paper of the reaction of composition in the above-mentioned blood and reagent, also can detect the importing situation of other the blood of for example blood being supplied with to the reagent paper of perforator towards blood access (blood pathway).
Detecting the occasion of blood to the importing of blood access, also can adopt following structure, for example form near the position of the blood access at least in the perforator with parts with light transmission (transparent), by means of blood collection testing agency, light is shone to this blood access, make reflected light or see through light to be subjected to light, carry out light-to-current inversion, by means of the voltage of controlling organization monitoring by the output of above-mentioned blood collection testing agency.With blood when above-mentioned blood access imports, the color at this position roughly is changed to reddish black, therefore, change from the reflected light at this position or the light quantity that sees through light, change from the voltage of above-mentioned blood collection testing agency output, with the detection of the variation of this output voltage (light quantity), can carry out the detection of blood collection.
Detect the blood collection testing agency of blood collection as above-mentioned with electric means, can use the pick off (electrode), biosensor of the impedance that for example detects (mensuration) perforator blood access etc. etc.
State in the use under the situation of biosensor, for example, when blood imported to above-mentioned blood access, the electric current of exporting from this biosensor changed, and therefore, utilizes the detection of the variation of this output current (current value), just can carry out the detection of blood collection.
In addition, under the situation of using the pick off that detects above-mentioned impedance, for example, when above-mentioned blood access imported, the impedance between this sensor electrode changed, and therefore, utilizes the detection of the variation of this impedance, just can carry out the detection of blood collection with blood.
Moreover, body fluid composition measuring apparatus of the present invention, reaction by composition in the above-mentioned blood and reagent, measure the colored intensity of the reagent paper of (colour examining) colour developing with optical mode, and convert, show, still to measured value, be not limited to this, for example, also can measure the potential change of giving birth to, convert, show to measured value with electric means according to the composition volume production in the corpse or other object for laboratory examination and chemical testing.
In above-mentioned form of implementation, adopted the structure of before measuring, removing decompression state, but also can adopt the structure that before measuring, relaxes decompression state in the present invention.
In addition, in the present invention, the driving that the mechanism of decompressor and perforator are kept out of the way mechanism also can be respectively manually to begin or to begin automatically.In the latter case, when for example being provided with near the fitting portion side of housing, with the pick off that moves of magnetic mode perception puncture needle forward end direction etc., keep out of the way mechanism according to the information-driven mechanism of decompressor and the perforator of this pick off at the puncture finger tip.
Below, the best form of implementation shown in describes the body fluid composition measuring apparatus of the present invention's second mode in detail with reference to the accompanying drawings.
In addition, in the following description, Fig. 1～Fig. 2, Fig. 5, Fig. 7～Figure 10 and Figure 13 are the accompanying drawings identical with the body fluid composition measuring apparatus of above-mentioned first mode, quote these accompanying drawings here.
Figure 15 and Figure 16 are equivalent to Fig. 3 and Fig. 4 of first mode, be respectively second mode first form of implementation (this word of following omission " second mode ") the puncture mechanism that body fluid composition measuring apparatus had and be built-in with the skiagraph of housing configuration example of puncture mechanism.Fig. 5, Figure 17～Figure 18 and Fig. 7～Figure 11 are respectively the skiagraphs of major part configuration example of the body fluid composition measuring apparatus of expression first form of implementation, Figure 19 is the block diagram that the body fluid composition measuring apparatus loop of expression first form of implementation constitutes, and Figure 20 is the flow chart of control action of controlling organization of the body fluid composition measuring apparatus of expression first form of implementation.In these figure, with the identical identical or suitable part of symbolic representation of symbol among Fig. 1～Figure 14.
In addition, in these figure, be that " cardinal extremity ", left side describe for " front end " with the right side of relative paper.
As Fig. 1, Fig. 5 and shown in Figure 19, the body fluid composition measuring apparatus of first form of implementation (blood constituent determinator) 1 comprises: body 2; Be arranged on the stopper section 3 on the body 2; Be contained in the puncture mechanism 4 in the housing 5; The perforator that is arranged on housing 5 base end sides is kept out of the way mechanism 6; The mensuration mechanism 7 of given composition in the blood (body fluid) that the collection of detection blood (body fluid) and mensuration are gathered; Make the pump 8 that becomes decompression state in the housing 5; Remove, relax or keep the electromagnetic valve 26 of the decompression state in the housing 5; Detect the pressure transducer (pressure detecting mechanism) 27 of housing 5 internal pressures; Solenoid (drive source) 28; Switch 29; Battery (power supply) 9; Be arranged on controlling organization 11 and memorizer 33 on the printed circuit board (PCB) 10; Display part (notifying operator) 12; Audio output unit (notifying operator) 32; Outside efferent 34.
This body fluid composition measuring apparatus 1 has been installed above-mentioned perforator shown in Figure 2 13 backs and has been used.Each element below is described.
In the wall portion 211 of framework 21 front, be formed with transverse shape inside and outside the perforation framework 21 and be circular opening 212.By this opening 212 perforator 13 described later is installed (maintenance) in housing 5.
In addition, on the face of the front of wall portion 211, the periphery around opening 212 is provided with and the corresponding formed finger of finger tip (finger) shape stopper section (stopper section that epidermal patch is leaned on) 3.Front in this stopper section 3 forms finger stop surface 31.Finger tip contacts on one side with this finger stopper section 3 (finger stop surface 31), Yi Bian drive body fluid composition measuring apparatus 1.Whereby, puncture finger tip, the amount of the given composition in the blood of measure gathering (below, in this form of implementation, be that representative describes) with the glucose.
Display window (opening) 221 on lid 22 inside and outside the formation perforation lid 22, this display window is covered by the plate-shaped member that transparent material constitutes.
Corresponding to the position in the spatial accommodation 23 of this display window 221, be provided with display part 12.Therefore, can confirm the various information that show by display part 12 by display window 221.
In addition, audio output unit 32 is by formations such as for example buzzer (sending the certain sound or the device of melody), sound-producing devices.
Moreover notifying operator is not limited to said structure, can also be other for example light emitting diode (LED) or light-emitting component, lamp, EL display element etc. such as EL element.
Also have, outside efferent 34 is with the external device (ED) output to for example personal computer and so on such as the data of the blood glucose value obtained etc.
On lid 22, be provided with action button 222.The formation of body fluid composition measuring apparatus 1 is that by pushing this action button 222, switch 29 connections with interlock with it input to controlling organization 11 from switch 29 with this signal.
Downside in Fig. 1 of display part 12 is provided with printed circuit board (PCB) 10, is equipped with the controlling organization 11 and the memorizer 33 that are made of microcomputer on this printed circuit board (PCB) 10.The exercises of these controlling organization 11 control examples such as blood collection whether judgement, decompression state whether body fluid composition measuring apparatus such as judgement 1.In addition, this controlling organization 11 is built-in with according to the checking computations portion of calculating the glucose amount (blood glucose value) in the blood from the signal of measuring mechanism 7.
The lower-left side is provided with the pump 8 as the mechanism of decompressor (attracting mechanism) in Fig. 1 of printed circuit board (PCB) 10.This pump 8 is with power-actuated, is connected with pipe 81 by the vent path 54 that forms on the housing 5 described later.This pipe 81 has flexible, is made of macromolecular materials such as for example polrvinyl chloride, polyethylene, polypropylene, ethene-vinyl acetate copolymer polyolefin such as (EVA), polyamide, polyester, silicone rubber, polyurethanes.
This pump 8 makes the inner cavity 52 of housing 5 become decompression state by the air in the inner cavity 52 that attracts, discharges housing 5.Particularly, this body fluid composition measuring apparatus 1 is before the puncture of the needle body 141 of perforator 13 described later, perhaps in puncture, perhaps after puncture, by the inner cavity 52 examination decompressions of 8 pairs of housings 5 of pump.
In addition, pump 8 also can be under the degree (for example, 100～400mmHg degree) of finger site of puncture sucking-off blood, makes the site of puncture of the inner cavity 52 of housing 5 and finger become the parts of decompression state.
Lower right side in Fig. 1 of printed circuit board (PCB) 10 is provided with the battery 9 as power supply.This battery 9 is electrically connected with pump 8, electromagnetic valve 26, solenoid 28, controlling organization 11, display part 12, audio output unit 32 etc., supplies with these parts and drives needed electric power.
Positive front side in Fig. 1 of pump 8 is equipped with measures mechanism 7.The supply (collection) of blood to the reagent paper 18 that has perforator 13 described later detects with optical mode in this mensuration mechanism 7, simultaneously, be determined at the glucose amount in the blood that scatters on the reagent paper 18 with optical mode, its be provided with the position is perforator 13 install, remain on reagent paper 18 positions one side under the state in the housing 5 near.
So, measure mechanism 7 and have the function of the collection that detects blood and the function that is determined at the amount of glucose in the blood that scatters on the reagent paper 18 (given composition) concurrently, therefore, compare with the situation that this mechanism is set respectively in each position, can reduce component number, simplify formation, and then reduce the assembling procedure of device.
This mensuration mechanism 7 has light-emitting component (light emitting diode) 71 and photo detector (photodiode) 72.
Light-emitting component 71 is electrically connected with controlling organization 11, and photo detector 72 is electrically connected with controlling organization 11 by amplifier 24 and A/D changer 25.
Light-emitting component 71 drives by the signal from controlling organization 11, and is luminous.This light is preferably with the intermittently luminous pulsed light of given interval.
Under the state that perforator 13 is installed in the housing 5, if make light-emitting component 71 luminous, the rayed reagent paper 18 that sends from light-emitting component 71 then, its reflected light is subjected to light by photo detector 72, carry out photoelectricity and change, from photo detector 72 outputs and this light income corresponding simulating signal, after this signal zooms into the signal of hope by amplifier 24, be transformed into digital signal by A/D changer 25, input to controlling organization 11.
Controlling organization 11 judges whether gather blood, promptly judge blood whether scattering on the reagent paper 18 of perforator 13 according to the signal of input.
Controlling organization 11 carries out given calculation process according to the signal of input, in addition, carries out revisal as required and calculates, and obtains the glucose amount (blood glucose value) in the blood, and the blood glucose value of obtaining is shown by display part 12.
Positive front side in the Fig. 1 that measures mechanism 7 is provided with housing 5 and keeps out of the way mechanism 6 with the perforator that is connected the base end side that places housing 5, is built-in with puncture mechanism 4 in the housing 5.
Perforator is kept out of the way mechanism 6 and is fixed on the framework 21, and on the other hand, housing 5 is not fixed on the framework 21, is being provided with movably along its axial (left and right directions among Fig. 1) but keep out of the way mechanism 6 by perforator.
As indicated above, this body fluid composition measuring apparatus 1 is installed to perforator 13 in the housing 5 and uses.Perforator 13 has adopted the same structure of structure that illustrates in the invention with first mode,, has omitted its explanation here.
This perforator 13 can freely be installed (chimeric) on housing 5 (fitting portion 53) by the opening 212 of above-mentioned framework 21 with loading and unloading.
Sidepiece at housing 5 forms communication with cavity portion 52 and outside vent path 54.This vent path 54 is connected with pump 8 by pipe 81.Air in the inner cavity 52 is attracted by vent path 54 and pipe 81 by pump 81, makes inner cavity 52 (containing in the perforator 13) become decompression state.
In addition, as shown in Figure 5, an end of pipe 82 is connected in the way of pipe 81, and the other end of pipe 82 opens wide towards the outside of body 21.This pipe 82 has flexible, by for example constituting with the same material of above-mentioned pipe 81.
In the way of pipe 82, be provided with the electromagnetic valve 26 of its stream of switching (opening/closing).
When closing electromagnetic valve 26 when state (closed), keep above-mentioned inner cavity 52 decompression state of (containing in the perforator 13), when opening electromagnetic valve 26 state of the unlatching (time), by pipe 82,81 and vent path 54, air (atmosphere) is imported in the inner cavity 52 of above-mentioned decompression state from the outside, remove or relax its decompression state.
Therefore, constitute the decompression cancel system by means of above-mentioned pipe (stream) 81,82 and electromagnetic valve 26.
As Figure 15 and shown in Figure 16,, form hole 511 at its central part roughly in the wall portion 51 of housing 5.In this hole 511, be provided with the inner tubule 65 that forms throttle orifice (path) 651.Air can pass through this throttle orifice 651, flows through between inner cavity 52 that is provided with by tubule 65 both sides and the variable volume described later chamber 631.
Cyclic sealing ring (seal member) 55 arranged in that the front end of housing 5 is chimeric.Therefore, when being installed in perforator 13 in the housing 5, the cardinal extremity of the flange 164 of perforator 13 contacts with sealing ring 55, keeps the air-tightness of inner cavity 52.
Sealing ring 55 is made of elastomer.As elastomer can be various elastomeric materials of natural rubber, isoprene rubber, butadiene rubber, styrene butadiene ribber, eyeball base butadiene rubber, neoprene, buttress rubber, acrylic rubber, ethylene-propylene rubber, Carbicron rubber, polyurethane rubber, silicone rubber, fluorubber and so on for example, or various thermoplastic elastomers such as polystyrene, polyolefin, polyvinyl chloride, polyurethanes system, polyester system, polyamide-based, polybutadiene system, fluorubber system.
From the fitting portion 53 of this housing 5, mechanism 4 is contained in the inner cavity 52 of base end side with puncture.This puncture mechanism 4 moves mounted thereto puncture needle 14 forward end directions, the surface of the blade tip puncture finger tip by needle body 141.
Leading section at plunger 41 is provided with cup-shaped punch block 411.The reducing diameter part 143 of puncture needle 14 can be entrenched in this punch block 411 with freely loading and unloading.In addition, be provided with the flexure strip 412 of elastically deformable at the base end part of plunger 41, this flexure strip 412 is provided with the holding section 413 of convex shape at front end.
State before being installed to perforator 13 in the housing 5 promptly, under the state (with reference to Figure 15) of puncture needle 14 before being installed in the plunger 41, holding section 413 is by means of the elastic force of flexure strip 412, be subjected to the effect of the elastic force of top in Figure 15, contact with the inner peripheral surface of housing 5.On the other hand, perforator 13 is installed in the housing 5 state promptly, puncture needle 14 is installed under the state (with reference to Figure 16) in the plunger 41, holding section 413 inserts that to connect housings 5 inside and outside and in the opening 57 that forms, engage with its edge portion.Whereby, the restriction plunger 41 forward extreme direction move.In addition, opening 57 is sealed by tabular seal member (seal member) 58, keeps the air-tightness of inner cavity 52.Sealing parts 58 are by constituting with the same material of above-mentioned sealing ring 55.
Helical spring (puncture spring) 42 is arranged on the base end side of plunger 41, and its two ends contact with plunger 41 and wall portion 51 respectively.On the other hand, helical spring (push back and use spring) 43 is arranged on the front of plunger 41, and its two ends contact with plunger 41 and fitting portion 53 respectively.
In addition, as shown in figure 19, in housing 5, be provided with pressure transducer 27, detect the pressure of the inner cavity 52 (comprising in the perforator 13) of housing 5 by this pressure transducer 27.Input to controlling organization 11 from the information of pressure transducer 27, the pressure (data) that promptly detects by pressure transducer 27.
In addition,, solenoid 28 is arranged, the drive source that drives as electric means in the outer setting of housing 5 as Figure 15 and shown in Figure 16.This solenoid 28 is configured to: by its plunger 281 holding section 413 (direction among the figure shown in the arrow) in inner cavity 52 is moved.
Under holding section 413 and state that opening 57 engages, helical spring 42 is in compressive state, to the plunger 41 extreme direction application of force forward.The plunger 281 of solenoid 28 direction shown in the arrow in the figure moves, and during by means of the fastening state of these plunger 281 engagement release portions 413, helical spring 42 elongations are moved plunger 41 forward end directions, the surface (skin) of the blade tip puncture finger tip of needle body 141.Therefore, the driving that the driving of puncture mechanism 4 is begun by means of above-mentioned solenoid 28 formations begins mechanism.
On the other hand, at this moment, helical spring 43 gives plunger 41 towards the proximal direction application of force by compression, that is to say, towards proximal direction pushing plunger 41.Afterwards, plunger 41 is made convergent mode of motion, and is static in the position of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.
Under plunger 41 immobilized states, the blade tip of needle body 141 places in the perforator 13.
Be provided with perforator at the base end side of housing 5 and keep out of the way mechanism 6.The structure that perforator is kept out of the way described in the invention of the mechanism 6 and first mode is same,, omits its repeat specification here.
In addition, utilize this body fluid composition measuring apparatus 1, as shown in figure 17, when finger tip 200 is pressed against on the stopper section 3, the preceding end in contact of the surface of finger tip 200 and abutment 163, oppress the blood capillary at the peripheral position of site of puncture 210 by means of the front end of this abutment 163, as shown in Figure 8, this site of puncture 210 that can keep finger tip 200 is decompression state, simultaneously, also can make perforator 13 leave finger tip 200, therefore, the blood capillary at peripheral position of site of puncture 210 of the front end compressing of abutment 163 is opened, can be more reliable and at short notice with blood 220 210 sucking-offs from the site of puncture, guarantee that glucose amount measures needed and adequate blood amount.
In addition, keep out of the way at perforator under the driving condition (state shown in Figure 8) of mechanism 6, housing 5 is moved to proximal direction, sealing ring 64 is in compressive state.As indicated above, because sealing ring 64 is made of elastomer, so, under state shown in Figure 8, to the housing 5 forward end direction application of forces.Whereby, open electromagnetic valve 26, when removing decompression state, sealing ring 64 returns original shape substantially under self elastic force effect, make housing 5 forward extreme direction move (with reference to Fig. 9, Figure 10).At this moment, the front end of the flange 56 of housing 5 contacts with the cardinal extremity of the protuberance 611 of body 61, thereby has limited undue move (with reference to Figure 10) of forward end direction.That is to say housing 5 and be installed in wherein perforator 13 and return perforator and keep out of the way position before mechanism 6 drives.
Below, with reference to Fig. 2, Fig. 5, Fig. 7～Figure 10, Figure 15～Figure 17 and flow chart shown in Figure 20, illustrate with body fluid composition measuring apparatus 1 puncture, the collection of blood, scatter and the situation of blood-sugar level measuring under the action of each several part and the control action of controlling organization.
(1) at first, in the fitting portion 53 of opening 212 by framework 21, make the reducing diameter part 143 and punch block 411 chimeric (with reference to Figure 16) of puncture needle 14 with perforator 13 insertion housings 5.
Then, when proximal direction is pressed into perforator 13, overcome the elastic force of helical spring 42, plunger 41 is moved towards proximal direction.Holding section 413 contacts with the inner peripheral surface of inner cavity 52 by the elastic force application of force of flexure strip 412, still, when holding section 413 is in the position of opening 57, inserts in the opening 57 (with reference to Figure 16).Thus, even remove the pushing force of the proximal direction of perforator 13, holding section 413 also engages with opening 57, and restriction plunger 41 is moving of extreme direction forward.At this moment, helical spring 42 is in compressive state.In this state, the preparation of the collection of the puncture preparation of end puncture mechanism 4 and blood (corpse or other object for laboratory examination and chemical testing).
(2) then, connect on and off switch not shown in the figures, thus, start the each several part of body fluid composition measuring apparatus 1, make it be in the state that to measure.In addition, close electromagnetic valve 26.
(3) secondly, finger tip (finger) 200 is pressed against on the stopper section 3.Thus, make finger tip 200 press the abutment 163 of perforator 13.At this moment, to reduce the mode of escape of air as far as possible, seal front opening 162 (with reference to Fig. 5) with finger tip 200.
(4) then, pressing operation aforesaid operations button 222 drives body fluid composition measuring apparatus 1.Whereby, implement program shown in Figure 20.
At first, controlling organization 11 is driving pump 8 before puncture, the attraction (the step S101 of Figure 20) of the air in the inner cavity 52 of beginning housing 5 (comprising in the perforator 13).
Thus, in the occasion without any problem, the pressure of inner cavity 52 (comprising in the perforator 13) reduces, and becomes decompression state (with reference to Figure 17).At this moment, the site of puncture 210 of the needle body 141 of finger tip 200 also is in decompression state.But in this state, the finger tip 200 that is positioned at abutment 163 inboards (front opening 162) bloats to the inside of perforator 13, becomes the hills shape, the peripheral position in the site of puncture 210 that the front end with abutment 163 is abutted against, compressing blood capillary.
Then, detect the interior pressure (the step S102 of Figure 20) of inner cavity 52 (comprising in the perforator 13) of housing 5 by pressure transducer 27.
Then, controlling organization 11 is based on from pressure transducer 27 information, judges whether inner cavity 52 (comprising in the perforator 13) becomes decompression state, the predefined setting pressure that promptly reduces pressure (pressure OK) whether (the step S103 of Figure 20).
In above-mentioned steps S103, be judged as under the situation that pressure OK do not have to realize, whether judgement time arrives (the step S104 of Figure 20).
In above-mentioned steps S104, under the situation about not arriving in the time of being judged as, carry out position correction and report (the step S105 of Figure 20).
In step S105, will the finger position situation about will revise of the finger stopper section 3 that reclines be shown at for example display part 12, perhaps report with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this position correction, can hold the thing situation, and finger position is moved to correct position, reduces leakage of air as much as possible, makes the posture of finger be in correct posture simultaneously.
Implement to return step S102 after the above-mentioned steps S105, the later processing of implementation step S102 once again in above-mentioned steps S104, is judged as under the situation that time is up, carries out error and reports (the step S106 of Figure 20).In addition, stop pump 8, open electromagnetic valve 26 once, and close once more.
In above-mentioned steps S106, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
(5) in above-mentioned steps S103, under the situation that is judged as pressure OK, the epidermis (the step S107 of Figure 20) of puncture finger tip 200.
In other words, controlling organization 11 is given the coil electricity of solenoid 28.Thus, the plunger 281 that makes solenoid 28 direction shown in the arrow in Figure 16 moves, and contacts with holding section 413, and holding section 413 is returned to inner cavity 52 thrusters.Whereby, the fastening state of engagement release portion 413 under the effect of helical spring 42 elastic force that compress, moves plunger 41 forward end directions, and needle body 141 is outstanding from front opening 162, the epidermis (with reference to Figure 18) of puncture finger tip 200.Produce hemorrhage from the site of puncture 210 of needle body 141.
Behind the needle body 141 puncture finger tips 200, helical spring 43 pushes plunger 41 towards proximal direction.Plunger 41 is through behind the convergent mode of motions, in the position static (with reference to Fig. 8) of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.At this moment, the blade tip of needle body 141 is contained in the perforator 13.So under the situation beyond when puncture, the blade tip of needle body 141 can not stretch out from front opening 162.Can eliminate the phenomenon of mistake with the skin equivalent damage, in addition, also can protect from infection, safety is good.
(6) attraction of the air in 8 pairs of above-mentioned inner cavity 52 of continuation said pump, the air in the variable volume chamber 631 flow out to inner cavity 52 gradually by throttle orifice 651, and the volume of variable volume chamber 631 is reduced gradually.Whereby, housing 5 and the perforator 13 that is mounted in it are to proximal direction, promptly begin gradually to move to the direction of leaving finger tip 200.
At this moment, owing to continue to keep the decompression state of the site of puncture 210 of inner cavity 52 and finger tip 200, so finger tip 200 can not unclamp from front opening 162.In addition, even perforator 13 moves towards the direction of leaving finger tip 200, finger tip 200 also contacts with stopper section 3, so, can be along with perforator 13 moves.Therefore, perforator 13 can leave finger tip 200 reliably.
Leave finger tip 200 by perforator 13, open gradually by the blood capillary at the peripheral position of the site of puncture 210 of this abutment 163 front ends compressing, can be from the site of puncture 210 sucking-off blood 220 (with reference to Fig. 9).In other words, compare, can promote hemorrhagely, guarantee needed blood flow volume at short notice with the situation that finger tip 200 and perforator 13 do not leave.
In addition, the minimum pressure that produces of this pump 8 degree of 100～400mmHg for example preferably.
Then, the cardinal extremity 591 of protuberance 59 contacts with the bottom surface of recess 621.Whereby, housing 5 and the perforator 13 that is mounted in it thereof stop towards the mobile of proximal direction.So, since perforator 13 can stop at apart from finger tip 200 suitably leave the distance between the place, so finger tip 200 can not unclamp from front opening 162.Thus, can prevent more reliably 210 sucking-offs from the site of puncture the dispersing of blood 220, to around pollution, improved safety.
As indicated above, utilize body fluid composition measuring apparatus 1, by once pushing of action button 222, the action of just can puncturing is substantially simultaneously moved with decompression, and in addition, the action of keeping out of the way of perforator 13 also is to utilize the decompression power of pump 8 to carry out, and, decompression described later is removed action and also can be begun automatically, so operability is very good.
(7) in the operation of above-mentioned (6), attracted in the perforator 13 with the granular blood 220 that on site of puncture 210, swells, importing guiding parts 166 with its inner blood that forms contacts, import reagent paper 18 by blood access 19, supply with the central part of reagent paper 18, with radial scattering (with reference to Fig. 2).
Along with the supply of blood 220 on reagent paper 18, scatter, the glucose in the blood 220 (composition that will measure) reacts with the reagent that remains on the reagent paper 18, reagent paper 18 develops the color according to glucose amount.
On the other hand, controlling organization 11 drive to be measured mechanism 7 after having implemented step S107 shown in Figure 20, measures the colour developing that mechanism 7 monitors (monitoring) reagent paper 18 by this, judges collection blood whether (the step S108 of Figure 20).
In step S108, when the voltage of signals value of importing from the photo detector 72 of measuring mechanism 7 surpasses predefined ultimate value, be judged as and gathered blood, when above-mentioned voltage of signals value is lower than this ultimate value, is judged as and does not gather blood.
Above-mentioned ultimate value is set at: compare very greatly with the above-mentioned voltage of signals value before making reagent paper 18 colour developing, and the above-mentioned voltage of signals value during with colour developing is compared very little.
In above-mentioned steps S108, be judged as under the situation of not gathering blood, whether judgement time arrives (the step S109 of Figure 20).
In above-mentioned steps S104, under the situation about not arriving in the time of being judged as, return step S108, the later processing of implementation step S108 once again is being judged as under the situation that time is up, carries out error and reports (the step S110 of Figure 20).In addition, stop pump 8, open electromagnetic valve 26 once, remove above-mentioned decompression state, and then close electromagnetic valve 26.
In above-mentioned steps S106, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
In addition, in above-mentioned steps S108, be judged as under the situation of having gathered blood, stopping pump 8, promptly stop the attraction (the step S111 of Figure 20) of the air in the above-mentioned inner cavity 52 of 8 pairs of pumps.
Then, open electromagnetic valve 26, remove above-mentioned decompression state (the step S112 of Figure 20).
In case open electromagnetic valve 26, exogenous QI (atmosphere) will flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210 through pipe 82,81 and vent path 54, makes inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure (with reference to Figure 10).
In addition, sealing ring 64 returns original shape substantially under the effect of self elastic force, make housing 5 forward extreme direction move (with reference to Figure 10, Figure 11).At this moment, the front end of the flange 56 of housing 5 contacts with the cardinal extremity of the protuberance 611 of body 61, can limit undue move (with reference to Figure 11) of housing 5 forward end directions.
Eliminated and returned atmospheric pressure if confirm as the attraction sense at peripheral position of the site of puncture 210 of finger tip 200, just made finger tip 200 leave the abutment 163 of perforator 13.
(8) after having implemented step S112 shown in Figure 20, controlling organization 11 is by measuring the colour developing degree that mechanism 7 measures above-mentioned reagent paper 18, according to the perform calculations revisals such as revisal calculating of processing, temperature revisal calculating, hematocrite value of resulting data, make blood glucose value quantification (the step S113 of Figure 20).
In this case, owing to removed inner cavity 52 decompression state of (comprising in the perforator 13), be the decompression state of the spatial accommodation of reagent paper 18, so, can supply with the glucose (composition that will measure) in the above-mentioned blood 220 fully and remain on composition (for example oxygen, carbon dioxide, steam etc.) in the needed atmosphere of reaction of reagent of reagent paper 18, thus, can more correctly measure blood glucose value.
Then, show above-mentioned blood glucose value of calculating (the step S114 of Figure 20) at display part 12.
Thus, can hold blood glucose value.
In addition, in above-mentioned steps S112, after removing decompression state, prepare the mensuration of next time, close electromagnetic valve 26 once more.
As indicated above, according to this body fluid composition measuring apparatus 1, can gather the blood of measuring needed and abundant amount at short notice reliably, simultaneously, can be correctly and measure blood glucose value (amount of the given composition in the blood) reliably.
And, before puncture, puncture owing to only drive puncture mechanism 4 in the occasion of trying decompression, affirmation decompression state, so the thing of pointing that can prevent to puncture redundantly takes place, therefore, can alleviate patient's burden.
In addition, owing in perforator 13, be provided with reagent paper 18, so the collection and the scattering, measuring on reagent paper 18 (quantification of composition) of puncture, blood can be carried out continuously, so, be easy to carry out at short notice the mensuration (composition measurement) of blood glucose value.
Moreover, be easy to carry out beamhouse operation in use, therefore, also more favourable for the situation of regular use or situation about using repeatedly.
The accident on live body surface etc. has improved safety in case can prevent to puncture once again mistakenly after the puncture.And, owing to can directly not see puncture needle 14, so, the fear when also having alleviated puncture.
From as can be seen above-mentioned, this body fluid composition measuring apparatus 1 is suitable for situation about using when patient oneself measures self blood glucose value etc.
In addition, this body fluid composition measuring apparatus 1 simple in structure, small-sized, light weight, cheap is so also be applicable to mass production.
Below, second form of implementation of the body fluid composition measuring apparatus of the present invention's second mode is described.
Figure 21 is the flow chart of the controlling organization control action of expression body fluid composition measuring apparatus second form of implementation of the present invention.Omit with the explanation of the common ground of the body fluid composition measuring apparatus of above-mentioned first form of implementation, main difference only is described.
The structure of the body fluid composition measuring apparatus 1 of this second form of implementation and the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation are same, so it illustrates omission, here, based on flow chart shown in Figure 21, with the difference with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation is the center, and its action is described.
In this body fluid composition measuring apparatus 1,, just implement program shown in Figure 21 in case action button 222 is carried out pressing operation.
At first, before puncture, controlling organization 11 driving pumps 8 begin to attract (the step S201 of Figure 21) to the air in the inner cavity 52 (comprising in the perforator 13) of housing 5.
Then, detect the interior pressure (the step S202 of Figure 21) of inner cavity 52 (comprising in the perforator 13) of housing 5 by pressure transducer 27.
Then, controlling organization 11 is based on from pressure transducer 27 information, judges whether inner cavity 52 (comprising in the perforator 13) becomes decompression state, the predefined setting pressure that promptly reduces pressure (pressure OK) whether (the step S203 of Figure 21).
In above-mentioned steps S203, being judged as under the situation that pressure OK do not have to realize, carry out error and report (the step S204 of Figure 21), in addition, stop pump 8, open electromagnetic valve 26 once, and close once more.
In above-mentioned steps S204, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
In above-mentioned steps S203, under the situation that is judged as pressure OK, the epidermis (the step S205 of Figure 21) of puncture finger tip 200.
Then, controlling organization 11 drives measures mechanisms 7, measures the colour developing that mechanism 7 monitors (monitoring) reagent paper 18 by this, judges collection blood whether (the step S206 of Figure 21).
In above-mentioned steps S206, be judged as under the situation of not gathering blood, whether judgement time arrives (the step S207 of Figure 21).
In above-mentioned steps S207, under the situation about not arriving in the time of being judged as, return step S206, the later processing of implementation step S206 once again is being judged as under the situation that time is up, carries out error and reports (the step S208 of Figure 21).In addition, stop pump 8, open electromagnetic valve 26 once, remove above-mentioned decompression state, and then close electromagnetic valve 26.
In above-mentioned steps S208, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
In addition, in above-mentioned steps S206, be judged as under the situation of having gathered blood, stopping pump 8, promptly stop the attraction (the step S209 of Figure 21) of the air in the above-mentioned inner cavity 52 of 8 pairs of pumps.
Then, open electromagnetic valve 26, remove above-mentioned decompression state (the step S210 of Figure 21).
Subsequently, by measuring the colour developing degree that mechanism 7 measures above-mentioned reagent paper 18,, make blood glucose value quantification (the step S211 of Figure 21) according to the perform calculations revisals such as revisal calculating of processing, temperature revisal calculating, hematocrite value of resulting data.
Then, show above-mentioned blood glucose value of calculating (the step S212 of Figure 21) at display part 12.
Thus, can hold blood glucose value.
In addition, in above-mentioned steps S210, after removing decompression state, prepare the mensuration of next time, close electromagnetic valve 26 once more.
According to this body fluid composition measuring apparatus 1, can obtain the effect same with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
Below, the 3rd form of implementation of the body fluid composition measuring apparatus of the present invention's second mode is described.
Figure 22 is the flow chart of the controlling organization control action of expression body fluid composition measuring apparatus the 3rd form of implementation of the present invention.Omit with the explanation of the common ground of the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation, main difference only is described.
The structure of the body fluid composition measuring apparatus 1 of the 3rd form of implementation and the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation are same, so it illustrates omission, here, based on flow chart shown in Figure 22, with the difference with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation is the center, and its action is described.
In this body fluid composition measuring apparatus 1,, just implement program shown in Figure 22 in case action button 222 is carried out pressing operation.
At first, before puncture, controlling organization 11 driving pumps 8 begin to attract (the step S301 of Figure 22) to the air in the inner cavity 52 (comprising in the perforator 13) of housing 5.
Then, detect the interior pressure (the step S302 of Figure 22) of inner cavity 52 (comprising in the perforator 13) of housing 5 by pressure transducer 27.
Then, controlling organization 11 is based on from pressure transducer 27 information, judges whether inner cavity 52 (comprising in the perforator 13) becomes decompression state, the predefined setting pressure that promptly reduces pressure (pressure OK) whether (the step S303 of Figure 22).
In above-mentioned steps S303, be judged as under the situation that pressure OK do not have to realize, whether judgement time arrives (the step S304 of Figure 22).
In above-mentioned steps S303, under the situation about not arriving in the time of being judged as, carry out position correction and report (the step S305 of Figure 22).
In step S305, will the finger position situation about will revise of the finger stopper section 3 that reclines be shown at for example display part 12, perhaps report with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this position correction, can hold the thing situation, and finger position is moved to correct position, reduces leakage of air as much as possible, makes the posture of finger be in correct posture simultaneously.
Implement to return step S302 after the above-mentioned steps S305, the later processing of implementation step S302 once again in above-mentioned steps S304, is being judged as under the situation that time is up, carries out error and reports (the step S306 of Figure 22).In addition, stop pump 8, open electromagnetic valve 26 once, and close once more.
In above-mentioned steps S306, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
In above-mentioned steps S303, under the situation that is judged as pressure OK, stop pump 8, promptly stop the attraction (the step S307 of Figure 22) of the air in 8 pairs of above-mentioned inner cavity 52 of pump.
Then, in case open electromagnetic valve 26, just remove above-mentioned decompression state (the step S308 of Figure 22).In addition, in step S308, after removing decompression state, close electromagnetic valve 26 once again.
Then, the epidermis (the step S309 of Figure 22) of puncture finger tip 200.
Subsequently, driving pump 8 begins to attract (the step S310 of Figure 22) to the air in the inner cavity 52 (comprising in the perforator 13) of housing 5.
Then, controlling organization 11 drives measures mechanisms 7, measures the colour developing that mechanism 7 monitors (monitoring) reagent paper 18 by this, judges collection blood whether (the step S311 of Figure 22).
In above-mentioned steps S311, be judged as under the situation of not gathering blood, whether judgement time arrives (the step S312 of Figure 22).
In above-mentioned steps S312, under the situation about not arriving in the time of being judged as, return step S311, the later processing of implementation step S311 once again is being judged as under the situation that time is up, carries out error and reports (the step S313 of Figure 22).In addition, stop pump 8, open electromagnetic valve 26 once, remove above-mentioned decompression state, and then close electromagnetic valve 26.
In above-mentioned steps S313, the situation that error arranged shows at for example display part 12, perhaps reported with sound by audio output unit 32.Certainly, this also can both carry out with display part 12 and audio output unit 32.
Operator's (user) reports according to this error, can hold the situation (situation that any trouble is arranged) of error.
In addition, in above-mentioned steps S311, be judged as under the situation of having gathered blood, stopping pump 8, promptly stop the attraction (the step S314 of Figure 22) of the air in the above-mentioned inner cavity 52 of 8 pairs of pumps.
Then, open electromagnetic valve 26, remove above-mentioned decompression state (the step S315 of Figure 22).
Subsequently, by measuring the colour developing degree that mechanism 7 measures above-mentioned reagent paper 18,, make blood glucose value quantification (the step S316 of Figure 22) according to the perform calculations revisals such as revisal calculating of processing, temperature revisal calculating, hematocrite value of resulting data.
Then, show above-mentioned blood glucose value of calculating (the step S317 of Figure 22) at display part 12.
Thus, can hold blood glucose value.
In addition, in above-mentioned steps S315, after removing decompression state, prepare the mensuration of next time, close electromagnetic valve 26 once more.
According to this body fluid composition measuring apparatus 1, can obtain the effect same with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
And, according to this body fluid composition measuring apparatus 1, owing to detecting under the situation of decompression state, the above-mentioned decompression state of temporary transient releasing punctures afterwards, can reduce because the bigger finger tip skin hardness that varies with each individual, cause the quantitative changeization of expansible skin at pressure, so relevant paracentesis depth aspect can puncture with higher precision.
In addition, the present invention also can omit for example above-mentioned steps S304 and step S305.
Below, the 4th embodiment of the present invention's second mode is described with reference to Figure 13.
The body fluid composition measuring apparatus 1 of the 4th form of implementation is compared with the body fluid composition measuring apparatus 1 of above-mentioned first～the 3rd form of implementation, except the formation difference of decompression cancel system, all the other and above-mentioned first～the 3rd form of implementation are same, here, avoid its repeat specification.
In other words, this body fluid composition measuring apparatus 1 is provided with tubule 83 as shown in figure 13, replaces the electromagnetic valve 26 of the body fluid composition measuring apparatus 1 of first～the 3rd form of implementation.
Tubule 83 is made of cylinder-like part, and its inside is formed with throttle orifice (stream) 831.The engaged at end (connection) of this tubule 83 and pipe 82, the front end of tubule 83 joints (discharge orifice 831) opens wide towards the outside of body 2.
The throttle orifice 831 of tubule 83 is owing to be thin gauge structure, and therefore, the resistance ratios that air passes through is bigger.The diameter of this throttle orifice 831 is not particularly limited, still, and for example if the degree of 0.01～0.3mm is relatively good.In addition, the length of throttle orifice 831 is not particularly limited, still, and for example if the degree of 5～15mm is relatively good.Be taken in the above-mentioned scope by diameter, can obtain the resistance of necessary sufficient air by (circulation) with throttle orifice 831.
Above-mentioned pipe (stream) 81,82 and tubule 83 constitute the decompression cancel system.
Tubule 83 is not limited to illustrated structure, and in addition, its number that number or throttle orifice are set can be as required for a plurality of.
Utilize this body fluid composition measuring apparatus 1, since the flow of the air that the driving of pump 8 attracts greater than (more than) flow of the exogenous QI (atmosphere) that flows into from the throttle orifice 831 of tubule 83, so, during driving pump 8, carry out the attraction of the air in the inner cavity 52 of housing 5, whereby, reduce inner cavity 52 pressure of (comprising in the perforator 13), make it be in decompression state.
Then, in case pump 8 is stopped, exogenous QI will flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210 through throttle orifice 831, pipe 82,81 and the vent path 54 of tubule 83, removes the decompression state of inner cavity 52 (comprising in the perforator 13) and site of puncture 210.In other words, inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure.
According to this body fluid composition measuring apparatus 1, can obtain the effect same with the body fluid composition measuring apparatus 1 of above-mentioned first～the 3rd form of implementation.
More than, though according to illustrated each form of implementation the body fluid composition measuring apparatus of the present invention's second mode has been described,, the present invention is not limited to this.For example, the formation of each several part also can be replaced as any formation that can bring into play said function.
In above-mentioned form of implementation, be illustrated with the representative of blood as the body fluid of gathering, still, in the present invention, the body fluid of collection is not limited to this, for example, also can be perspiration, lymph fluid, bone marrow fluid etc.
In addition, in above-mentioned form of implementation, as the composition of measuring purpose, with glucose (blood glucose value) is that representative is illustrated, but, the present invention for example, also can be inorganic ionss such as albumen, cholesterol, uric acid, creatine class amide, ethanol, sodium etc. being not limited to this aspect the composition of measuring purpose.
In addition, in above-mentioned form of implementation, measure the amount that mechanism is used for measuring given composition, still, in the present invention, measure the character that mechanism also can measure given composition, in addition, can also measure the amount and the character of given composition.
Moreover in the present invention, the pressure when gathering blood in the spatial accommodation (inner cavity 52) of the captivation puncture needle of pump 8 also can be certain pressure, can also be the pressure that changes (time to time change).
Figure 23 and Figure 24 show the interior pressure pattern of spatial accommodation (inner cavity 52) of puncture needle when gathering blood.
In the present invention, for example as shown in figure 23, the pressure in the spatial accommodation of puncture needle (inner cavity 52) also can alternately switch to low pressure and high pressure, in addition, as shown in figure 24, also can increase the interior pressure of spatial accommodation (inner cavity 52) of puncture needle gradually.In this case, the moment of puncture is not particularly limited.
By changing the pressure in the spatial accommodation (inner cavity 52), can in the shorter time, gather the needed adequate blood amount of measuring reliably.
In addition, in above-mentioned form of implementation, pressure detecting mechanism has used pressure transducer, and still, the present invention is not limited to this, also can use other for example position sensor etc.
As pressure detecting mechanism, under the situation of use location pick off, for example on housing 5, set in advance labelling, position pick offs such as optical chopper are set on the framework 21 of body 2, when pressure changes, when housing 5 importing perforators are kept out of the way mechanism 6, it is detected by this position sensor.
In above-mentioned form of implementation, though be provided with blood collection testing agency that is also used as the collection that detects blood and the mechanism that measures the mensuration mechanism of the amount of given composition in the blood (in form of implementation, this mechanism being called " measuring mechanism "), but, blood collection testing agency also can be set respectively in the present invention and measure mechanism.
In above-mentioned form of implementation, as blood collection testing agency, though what use is the mechanism of detecting blood collection with optical mode,, the present invention is not limited to this, also can use other the mechanism of for example detecting with electric means.
In addition, in the present invention, under the situation of the blood collection testing agency that uses the collection that detects blood with optical mode, be not limited to detect the colour developing (color development) of reagent paper of the reaction of composition in the above-mentioned blood and reagent, also can detect the importing situation of other the blood of for example blood being supplied with to the reagent paper of perforator towards blood access (blood pathway).
Detecting the occasion of blood to the importing situation of blood access, also can adopt following structure, for example form near the position of the blood access at least in the perforator with parts with light transmission (transparent), by means of blood collection testing agency, light is shone to this blood access, make reflected light or see through light to be subjected to light, carry out light-to-current inversion, by means of the voltage of controlling organization monitoring by the output of above-mentioned blood collection testing agency.With blood when above-mentioned blood access imports, the color at this position roughly is changed to reddish black, therefore, change from the reflected light at this position or the light quantity that sees through light, change from the voltage of above-mentioned blood collection testing agency output, with the detection of the variation of this output voltage (light quantity), can carry out the detection of blood collection.
Detect the blood collection testing agency of blood collection as above-mentioned with electric means, can use the pick off (electrode), biosensor of the impedance that for example detects (mensuration) perforator blood access etc. etc.
State in the use under the situation of biosensor, for example, when blood imported to above-mentioned blood access, the electric current of exporting from this biosensor changed, and therefore, utilizes the detection of the variation of this output current (current value), just can carry out the detection of blood collection.
In addition, under the situation of using the pick off that detects above-mentioned impedance, for example, when above-mentioned blood access imported, the impedance between this sensor electrode changed, and therefore, utilizes the detection of the variation of this impedance, just can carry out the detection of blood collection with blood.
Moreover, body fluid composition measuring apparatus of the present invention is the reaction by composition in the above-mentioned blood and reagent, measure the colored intensity of the reagent paper of (colour examining) colour developing with optical mode, and to measured value conversion, demonstration, but, be not limited to this, for example, also can measure the potential change of giving birth to, convert, show to measured value with electric means according to the composition volume production in the corpse or other object for laboratory examination and chemical testing.
In above-mentioned form of implementation, adopted the structure of before measuring, removing decompression state, but also can adopt the structure that before measuring, relaxes decompression state in the present invention.
In addition, in the present invention, the driving that the mechanism of decompressor and perforator are kept out of the way mechanism also can be respectively manually to begin or to begin automatically.
Below, based on best form of implementation shown in the drawings, describe the body fluid composition measuring apparatus of Third Way of the present invention in detail.
In the following description, quote Fig. 2 and Fig. 9 with the identical accompanying drawing of above-mentioned first form of implementation.
Figure 25 is the perspective view of (this term of following omission " Third Way ") body fluid composition measuring apparatus first form of implementation of the pattern ground expression Third Way suitable with Fig. 1 of first mode.Figure 26～27th, expression puncture mechanism and be built-in with the skiagraph of the housing configuration example of puncture mechanism, except perforator was kept out of the way 600 replacements of 61 usefulness support sectors of mechanism, all the other were and Fig. 3 and the suitable accompanying drawing of Fig. 4.Figure 28～Figure 31 is the skiagraph of the expression first form of implementation body fluid composition measuring apparatus major part configuration example, and except perforator was kept out of the way 600 replacements of 61 usefulness support sectors of mechanism, all the other were suitable with Fig. 5, Fig. 6, Fig. 8 and Figure 10 respectively accompanying drawings.
Figure 32 is the flow chart of the controlling organization control action of the expression first form of implementation body fluid composition measuring apparatus.In the figure, with symbol identical among the above-mentioned figure, represent identical or suitable part.
In addition, in these figure, be that " cardinal extremity ", left side describe for " front end " with the right side of relative paper.
As Figure 25, Figure 28 and shown in Figure 9, the body fluid composition measuring apparatus of first form of implementation (blood constituent determinator) 1 comprises: body 2; Be arranged on the stopper section 3 on the body 2; Be contained in the puncture mechanism 4 in the housing 5; The perforator that is arranged on housing 5 base end sides is kept out of the way mechanism 6; The mensuration mechanism 7 of given composition in the blood (body fluid) that the collection of detection blood (body fluid) and mensuration are gathered; Make the pump 8 that becomes decompression state in the housing 5; Remove, relax or keep the electromagnetic valve 26 of the decompression state in the housing 5; Detect the pressure transducer (pressure detecting mechanism) 27 of housing 5 internal pressures; Solenoid (drive source) 28; Switch 29; Battery (power supply) 9; Be arranged on controlling organization 11 and memorizer 33 on the printed circuit board (PCB) 10; Display part (notifying operator) 12; Audio output unit (notifying operator) 32; Outside efferent 34.
This body fluid composition measuring apparatus 1 is installed perforator 13 backs and is used.Each element below is described.
In the wall portion 211 of framework 21 front, be formed with transverse shape inside and outside the perforation framework 21 and be circular opening 212.By this opening 212 perforator 13 described later is installed (maintenance) in housing 5.
In addition, on the face of the front of wall portion 211, the periphery around opening 212 is provided with and the corresponding formed finger of finger tip (finger) shape stopper section (stopper section that epidermal patch is leaned on) 3.Front in this stopper section 3 forms finger stop surface 31.Finger tip contacts on one side with this finger stopper section 3 (finger stop surface 31), Yi Bian drive body fluid composition measuring apparatus 1.Whereby, puncture finger tip, the amount of the given composition in the blood of measure gathering (below, in this form of implementation, be that representative describes) with the glucose.
Display window (opening) 221 on lid 22 inside and outside the formation perforation lid 22, this display window is covered by the plate-shaped member that transparent material constitutes.
Corresponding to the position in the spatial accommodation 23 of this display window 221, be provided with display part 12.Therefore, can confirm the various information that show by display part 12 by display window 221.
In addition, audio output unit 32 is by formations such as for example buzzer (sending the certain sound or the device of melody), sound-producing devices.
Moreover notifying operator is not limited to said structure, can also be other for example light emitting diode (LED) or light-emitting component, lamp, EL display element etc. such as EL element.
Also have, outside efferent 34 is with the external device (ED) output to for example personal computer and so on such as the data of the blood glucose value obtained etc.
On lid 22, be provided with action button 222.The formation of body fluid composition measuring apparatus 1 is that by pushing this action button 222, switch 29 connections with interlock with it input to controlling organization 11 from switch 29 with this signal.
Downside in Figure 25 of display part 12 is provided with printed circuit board (PCB) 10, is equipped with the controlling organization 11 and the memorizer 33 that are made of microcomputer on this printed circuit board (PCB) 10.The exercises of these controlling organization 11 control examples such as blood collection whether body fluid composition measuring apparatus such as judgement 1.In addition, this controlling organization 11 is built-in with according to the checking computations portion of calculating the glucose amount (blood glucose value) in the blood from the signal of measuring mechanism 7.
The lower-left side is provided with the pump 8 as the mechanism of decompressor (attracting mechanism) in Figure 25 of printed circuit board (PCB) 10.This pump 8 is with power-actuated, is connected with pipe 81 by the vent path 54 that forms on the housing 5 described later.This pipe 81 has flexible, is made of macromolecular materials such as for example polrvinyl chloride, polyethylene, polypropylene, ethene-vinyl acetate copolymer polyolefin such as (EVA), polyamide, polyester, silicone rubber, polyurethanes.
This pump 8 makes the inner cavity 52 of housing 5 become decompression state by the air in the inner cavity 52 that attracts, discharges housing 5.
In addition, pump 8 also can make the inner cavity 52 of housing 5 and the site of puncture of finger become decompression state under the degree (for example, 100～600mmHg degree) of finger site of puncture sucking-off blood.
Lower right side in Figure 25 of printed circuit board (PCB) 10 is provided with the battery 9 as power supply.This battery 9 is electrically connected with pump 8, electromagnetic valve 26, solenoid 28, controlling organization 11, display part 12, audio output unit 32 etc., supplies with these parts and drives needed electric power.
Positive front side in Figure 25 of pump 8 is equipped with measures mechanism 7.The supply (collection) of blood to the reagent paper 18 that has perforator 13 described later detects with optical mode in this mensuration mechanism 7, simultaneously, be determined at the glucose amount in the blood that scatters on the reagent paper 18 with optical mode, its be provided with the position is perforator 13 install, remain on reagent paper 18 positions one side under the state in the housing 5 near.
So, measure mechanism 7 and have the function of the collection that detects blood and the function that is determined at the amount of glucose in the blood that scatters on the reagent paper 18 (given composition) concurrently, therefore, compare with the situation that this mechanism is set respectively in each position, can reduce component number, simplify formation, and then reduce the assembling procedure of device.
This mensuration mechanism 7 has light-emitting component (light emitting diode) 71 and photo detector (photodiode) 72.
Light-emitting component 71 is electrically connected with controlling organization 11, and photo detector 72 is electrically connected with controlling organization 11 by amplifier 24 and A/D changer 25.
Light-emitting component 71 drives by the signal from controlling organization 11, and is luminous.This light is preferably with the intermittently luminous pulsed light of given interval.
Under the state that perforator 13 is installed in the housing 5, if make light-emitting component 71 luminous, the rayed reagent paper 18 that sends from light-emitting component 71 then, its reflected light is subjected to light by photo detector 72, carry out photoelectricity and change, from photo detector 72 outputs and this light income corresponding simulating signal, after this signal zooms into the signal of hope by amplifier 24, be transformed into digital signal by A/D changer 25, input to controlling organization 11.
Controlling organization 11 judges whether gather blood, promptly judge blood whether scattering on the reagent paper 18 of perforator 13 according to the signal of input.
Controlling organization 11 carries out given calculation process according to the signal of input, in addition, carries out revisal as required and calculates, and obtains the glucose amount (blood glucose value) in the blood, and the blood glucose value of obtaining is shown by display part 12.
Positive front side in measuring Figure 25 of mechanism 7 is provided with the housing 5 of built-in puncture mechanism 4.
As indicated above, this body fluid composition measuring apparatus 1 is installed to perforator 13 in the housing 5 and uses.Perforator 13 as shown in Figure 2, by puncture needle 14, hold first housing 15 of puncture needle 14, second housing 16 that is arranged on first housing, 15 peripheral parts, the reagent paper fixed part 17 that is arranged on second housing, 16 peripheral parts, the reagent paper 18 that is fixed on the reagent paper fixed part 17 slidably and constitute.
Puncture needle 14 is made of needle body 141, the handle 142 that is fixed on needle body 141 base end sides, and is contained in the inner cavity 152 of first housing 15.
Hollow part or solid parts that needle body 141 is made by for example metal materials such as rustless steel, aluminum, aluminium alloy, titanium, titanium alloy constitute, and its front end forms sharp keen blade tip (needle point), by means of the epidermis (skin) of this blade tip puncture finger tip.
In addition, handle 142 roughly is made of columnar component, and its peripheral part contacts with the inner peripheral surface of first housing 15 and slides.
Form the reducing diameter part 143 of undergauge at the base end part of handle 142.The punch block 411 of the plunger 41 of this reducing diameter part 143 and formation described later puncture mechanism 4 is chimeric.
It is circular hole 154 that the substantial middle portion of wall portion 153 forms transverse shape.Pass through this hole 154 during the epidermis of needle body 141 puncture finger tips (finger).In addition, the external diameter less than handle 142 front ends is set in the aperture in this hole 154 for.Therefore, in case puncture needle 14 moves to the preceding extreme direction of inner cavity 152, when the front end of handle 142 is contacted with the cardinal extremity of wall portion 153, can prevent from that puncture needle 14 forward end directions are undue to move.Therefore, during needle body 141 puncture finger tips, the length outstanding from perforator 13 front ends remains necessarily.Thereby the blade tip that can prevent needle body 141 reliably excessively, puncture too deeply.
In addition, be provided with the mechanism that is used to regulate plunger 41 displacements described later, thus, also can regulate the paracentesis depth of the blade tip of needle body 141 finger tip.
Fixing second housing 16 at the peripheral part of first housing 15.
Front end at second housing 16 is formed with the outstanding abutment 163 of ring-type.This abutment 163 is positions that finger tip presses, and its inboard is formed with and makes inner cavity 161 open front end openings (opening) 162.The shape of the front end outer peripheral edges of abutment 163 is made: the effect of the pain in the time of relaxing the peripheral irriate of puncture, puncture when being suitable for bringing into play finger tip and pressing; In addition, also make such shape: when becoming decompression state, can suppress air as possible from the front end of abutment 163 and the inflow between the finger tip surface by pump 8.In addition, can abutment 163 be set yet, but the front end face of second housing 16 is made tabular surface at the front end of second housing 16.
On second housing 16, near the peripheral part the cardinal extremity of abutment 163 forms outstanding laterally collar flange 164.Under the state of this collar flange 164 in being installed on housing 5 described later, the preceding end in contact of its cardinal extremity and housing 5, the position of stipulating relative housing 5.
Peripheral part at second housing 16 forms recess 165, and the reagent paper fixed part 17 that is used to be provided with discoid reagent paper 18 is installed on this recess 165.
In addition, on the inner peripheral surface of second housing 16, form to inner cavity 161 outstanding blood and import guiding parts 166.This blood imports guiding parts 166 and has the function of accepting to flow into from front opening 162 blood (corpse or other object for laboratory examination and chemical testing) of inner cavity 161 behind the puncture finger tip.
In this perforator 13, form the inner cavity 161 and outside blood access 19 that are communicated with second housing 16 through second housing 16, reagent paper fixed part 17.This blood access 19 is blood that puncture is obtained streams to reagent paper 18 guiding, has passage opening 191 that opens wide to inner cavity 161 and the passage opening 192 that opens wide to the outside of perforator 13.In addition, passage opening 192 is positioned at the central part of reagent paper 18.
Blood imports guiding parts 166 and forms near passage opening 191.Therefore, will import the blood that guiding parts 166 accepts by blood more effectively is directed to the blood access 19 from passage opening 191.This blood arrives passage opening 192 by capillarity, supplies with the central part of the reagent paper 18 that is provided with the form of closing passage opening 192, scatters with radial.
This reagent paper 18 is can absorb, maintain reagent on the carrier of the blood that scatters.As carrier can be the flake porous plastid of non-woven fabrics, fabric, prolonged treatment sheet material etc. for example.The best possess hydrophilic property of this porous plastid.
The reagent that remains on the carrier can suitably be determined according to the composition that will measure in the blood (corpse or other object for laboratory examination and chemical testing).For example, under the situation that blood-sugar level measuring is used, can be for example glucoseoxidase (GOD), peroxidase (POD) and for example developer (colour reagent) of 4-amino-antipyrine, N-ethyl-N-(2-hydroxyl-3-sulfo group propyl group)-m-toluidines and so on, in addition, according to measuring composition, also can be for example ascorbic acid oxidase, Alcohol oxidase, cholesterol oxidase etc. and the blood constituent reaction and with above-mentioned same developer (colour reagent).The demulcent that can also comprise in addition, phosphate buffer and so on.Self-evident, kind, the composition of reagent are not limited to this.
This perforator 13 can freely be installed (chimeric) on housing 5 (fitting portion 53) by the opening 212 of above-mentioned framework 21 with loading and unloading.
As Figure 25, Figure 26 and shown in Figure 27,, be fixed with the support sector 600 of round-ended cylinder shape at the base end side of framework 21.The base end part of housing 5 is entrenched in this support sector 600.
Sidepiece at housing 5 forms communication with cavity portion 52 and outside vent path 54.This vent path 54 is connected with pump 8 by pipe 81.Air in the inner cavity 52 is attracted by vent path 54 and pipe 81 by pump 81, makes inner cavity 52 (containing in the perforator 13) become decompression state.
In addition, as shown in figure 28, an end of pipe 82 is connected in the way of pipe 81, and the other end of pipe 82 opens wide towards the outside of body 2.This pipe 82 has flexible, by for example constituting with the same material of above-mentioned pipe 81.
In the way of pipe 82, be provided with the electromagnetic valve 26 of its stream of switching (opening/closing).
When closing electromagnetic valve 26 when state (closed), keep above-mentioned inner cavity 52 decompression state of (containing in the perforator 13), when opening electromagnetic valve 26 state of the unlatching (time), by pipe 82,81 and vent path 54, air (atmosphere) is imported in the inner cavity 52 of above-mentioned decompression state from the outside, remove or relax its decompression state.
Therefore, constitute the decompression cancel system by means of above-mentioned pipe (stream) 81,82 and electromagnetic valve 26.
In addition, constitute the pressure regulating mechanism of the pressure of regulating inner cavity 52 (containing in the perforator 13) by above-mentioned decompression cancel system and pump 8.
Cyclic sealing ring (seal member) 55 arranged in that the front end of housing 5 is chimeric.Therefore, when being installed in perforator 13 in the housing 5, the cardinal extremity of the flange 164 of perforator 13 contacts with sealing ring 55, keeps the air-tightness of inner cavity 52.
Sealing ring 55 is made of elastomer.As elastomer can be various elastomeric materials of natural rubber, isoprene rubber, butadiene rubber, styrene butadiene ribber, eyeball base butadiene rubber, neoprene, buttress rubber, acrylic rubber, ethylene-propylene rubber, Carbicron rubber, polyurethane rubber, silicone rubber, fluorubber and so on for example, or various thermoplastic elastomers such as polystyrene, polyolefin, polyvinyl chloride, polyurethanes system, polyester system, polyamide-based, polybutadiene system, fluorubber system.
From the fitting portion 53 of this housing 5, mechanism 4 is contained in the inner cavity 52 of base end side with puncture.This puncture mechanism 4 moves mounted thereto puncture needle 14 forward end directions, the surface of the blade tip puncture finger tip by needle body 141.
Leading section at plunger 41 is provided with cup-shaped punch block 411.The reducing diameter part 143 of puncture needle 14 can be entrenched in this punch block 411 with freely loading and unloading.In addition, be provided with the flexure strip 412 of elastically deformable at the base end part of plunger 41, this flexure strip 412 is provided with the holding section 413 of convex shape at front end.
State before being installed to perforator 13 in the housing 5 promptly, under the state (with reference to Figure 26) of puncture needle 14 before being installed in the plunger 41, holding section 413 is by means of the elastic force of flexure strip 412, be subjected to the effect of the elastic force of top in Figure 26, contact with the inner peripheral surface of housing 5.On the other hand, perforator 13 is installed in the housing 5 state promptly, puncture needle 14 is installed under the state (with reference to Figure 27) in the plunger 41, holding section 413 inserts that to connect housings 5 inside and outside and in the opening 57 that forms, engage with its edge portion.Whereby, the restriction plunger 41 forward extreme direction move.In addition, opening 57 is sealed by tabular seal member (seal member) 58, keeps the air-tightness of inner cavity 52.Sealing parts 58 are by constituting with the same material of above-mentioned sealing ring 55.
Helical spring (puncture spring) 42 is arranged on the base end side of plunger 41, and its two ends contact with plunger 41 and wall portion 51 respectively.On the other hand, helical spring (push back and use spring) 43 is arranged on the front of plunger 41, and its two ends contact with plunger 41 and fitting portion 53 respectively.
In addition, in housing 5, be provided with pressure transducer 27, detect the pressure of the inner cavity 52 (comprising in the perforator 13) of housing 5 by this pressure transducer 27.Input to controlling organization 11 from the information of pressure transducer 27, the pressure (data) that promptly detects by pressure transducer 27.
In addition,, solenoid 28 is arranged, the drive source that drives as electric means in the outer setting of housing 5 as Figure 26 and shown in Figure 27.This solenoid 28 is configured to: by its plunger 281 holding section 413 (direction among the figure shown in the arrow) in inner cavity 52 is moved.
Under holding section 413 and state that opening 57 engages, helical spring 42 is in compressive state, to the plunger 41 extreme direction application of force forward.The plunger 281 of solenoid 28 direction shown in the arrow in the figure moves, and during by means of the fastening state of these plunger 281 engagement release portions 413, helical spring 42 elongations are moved plunger 41 forward end directions, the surface (skin) of the blade tip puncture finger tip of needle body 141.Therefore, the driving that the driving of puncture mechanism 4 is begun by means of above-mentioned solenoid 28 formations begins mechanism.
On the other hand, at this moment, helical spring 43 gives plunger 41 towards the proximal direction application of force by compression, that is to say, towards proximal direction pushing plunger 41.Afterwards, plunger 41 is made convergent mode of motion, and is static in the position of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.
Under plunger 41 immobilized states, the blade tip of needle body 141 places in the perforator 13.
In addition, utilize this body fluid composition measuring apparatus 1, when perforator 13 inserts the fitting portion 53 of housings 5, reducing diameter part 143 and the punch block 411 when chimeric that makes puncture needle 14, the front end of abutment 163 is positioned at and the roughly the same position of finger stop surface 31, perhaps from finger stop surface 31 outstanding (with reference to Figure 27 and Figure 28) a little.Whereby, when finger tip 200 contacted with stopper section 3, the surface energy of finger tip 200 contacted with abutment 163 reliably, and front opening 162 is sealed.
Above Shuo Ming body fluid composition measuring apparatus 1, when gathering blood from the site of puncture, based on information from pressure transducer 27, the driving of control pump 8 and electromagnetic valve 26, to reducing pressure in the inner cavity 52 (comprising in the perforator 13), make its pressure change (variation) in time.
In addition, the pressure patterns in the inner cavity 52 when gathering above-mentioned blood comprise decompression time, and pressure can change in time, but are not particularly limited.Below, an one example is described.
The curve chart of the pressure pattern when Figure 33 is expression collection blood in the inner cavity 52.
As shown in the drawing, when gathering blood with above-mentioned body fluid composition measuring apparatus 1, the driving of control pump 8 and electromagnetic valve 26 alternately switches to subatmospheric first pressure P 1 and second pressure P 2 that is higher than this first pressure P 1 with the pressure in the inner cavity 52.
Thus, can in shorter time, gather the blood of measuring needed abundant amount reliably.
Above-mentioned second pressure P 2 is can be with atmospheric pressure roughly the same or be lower than atmospheric pressure.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
In addition, the degree that above-mentioned first pressure P 1 is got 100～600mmHg is relatively good, preferably the degree of 400～600mmHg.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
It is relatively good that the difference of above-mentioned second pressure P 2 and first pressure P 1 is got the degree of 100～600mmHg, preferably the degree of 300～600mmHg.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
Moreover it is relatively good that the period T of above-mentioned pressure oscillation is got the degree of 1～30sec, preferably the degree of 1～5sec.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
In addition, in the present invention, the shape of each waveform shown in Figure 33 both can be each other about equally, also can part or all difference.
Below, with reference to Fig. 2, Fig. 9, Figure 26～Figure 31 and flow chart shown in Figure 32, illustrate with body fluid composition measuring apparatus 1 puncture, the collection of blood, scatter and the situation of blood-sugar level measuring under the action of each several part and the control action of controlling organization.
(1) at first, in the fitting portion 53 of opening 212 by framework 21, make the reducing diameter part 143 and punch block 411 chimeric (with reference to Figure 27) of puncture needle 14 with perforator 13 insertion housings 5.
Then, when proximal direction is pressed into perforator 13, overcome the elastic force of helical spring 42, plunger 41 is moved towards proximal direction.Holding section 413 contacts with the inner peripheral surface of inner cavity 52 by the elastic force application of force of flexure strip 412, still, when holding section 413 is in the position of opening 57, inserts in the opening 57 (with reference to Figure 27).Thus, even remove the pushing force of the proximal direction of perforator 13, holding section 413 also engages with opening 57, and restriction plunger 41 is moving of extreme direction forward.At this moment, helical spring 42 is in compressive state.In this state, the preparation of the collection of the puncture preparation of end puncture mechanism 4 and blood (corpse or other object for laboratory examination and chemical testing).
(2) then, connect on and off switch not shown in the figures, thus, start the each several part of body fluid composition measuring apparatus 1, make it be in the state that to measure.In addition, close electromagnetic valve 26.
(3) secondly, finger tip (finger) 200 is pressed against on the stopper section 3.Thus, make finger tip 200 press the abutment 163 of perforator 13.At this moment, to reduce the mode of escape of air as far as possible, seal front opening 162 (with reference to Figure 28) with finger tip 200.
(4) then, pressing operation aforesaid operations button 222 drives body fluid composition measuring apparatus 1.Thus, implement program shown in Figure 32.
At first, by the surface (the step S407 of Figure 32) of the needle body 141 puncture finger tips 200 of puncture needle 14.
In other words, controlling organization 11 is given the coil electricity of solenoid 28.Thus, the plunger 281 that makes solenoid 28 direction shown in the arrow in Figure 27 moves, and contacts with holding section 413, and holding section 413 is returned to inner cavity 52 thrusters.Whereby, the fastening state of engagement release portion 413 under the effect of helical spring 42 elastic force that compress, moves plunger 41 forward end directions, and needle body 141 is outstanding from front opening 162, the epidermis (with reference to Figure 29) of puncture finger tip 200.Produce hemorrhage from the site of puncture 210 of needle body 141.
Behind the needle body 141 puncture finger tips 200, helical spring 43 pushes back plunger 41 towards proximal direction.Plunger 41 is through behind the convergent mode of motions, in the position static (with reference to Figure 30) of the Spring balanced of the elastic force of helical spring 42 and helical spring 43.At this moment, the blade tip of needle body 141 is contained in the perforator 13.So under the situation beyond when puncture, the blade tip of needle body 141 can not stretch out from front opening 162.Can eliminate the phenomenon of mistake with the skin equivalent damage, in addition, also can protect from infection, safety is good.
Then, the driving (the step S402 of Figure 32) of controlling organization 11 beginning control pumps 8 and electromagnetic valve 26.
In other words, the driving of controlling organization 11 control pumps 8 and electromagnetic valve 26 as shown in figure 33, alternately switches to first pressure P 1 and second pressure P 2 with the pressure of inner cavity 52 (contain perforator 13 in).In addition, near also change (variation) similarly therewith of the pressure the site of puncture 210 of the needle body 141 of finger tip 200.
In this occasion, at first, driving pump 8 under the state of closing electromagnetic valve 26, carry out the attraction of the air in the inner cavity 52 of housing 5, with the pressure of chamber portion 52 this first pressure P 1 that reduces pressure, to keep this first pressure P 1 preset time.
Then, pump 8 is stopped, opening electromagnetic valve 26, discharge the air in the inner cavity 52, the pressure that makes inner cavity 52 is second pressure P 2, keeping this second pressure P 2 preset time, after, carry out this action repeatedly.
Therefore, can be from the site of puncture 210 sucking-off blood 220 (with reference to Figure 30).Particularly, remain certain situation with pressure and compare, can guarantee necessary blood flow volume at short notice reliably inner cavity 52.
As indicated above, according to this body fluid composition measuring apparatus 1, by a pressing operation button 222, puncture action and decompression action in addition, also can automatically begin decompression described later and remove action, and therefore, its operability is very good.
(5) in the operation of above-mentioned (4), attracted in the perforator 13 with the granular blood 220 that on site of puncture 210, swells, importing guiding parts 166 with its inner blood that forms contacts, import reagent paper 18 by blood access 19, supply with the central part of reagent paper 18, with radial scattering (with reference to Fig. 2).
Along with the supply of blood 220 on reagent paper 18, scatter, the glucose in the blood 220 (composition that will measure) reacts with the reagent that remains on the reagent paper 18, reagent paper 18 develops the color according to glucose amount.
On the other hand, controlling organization 11 drive to be measured mechanism 7 after having implemented step S402 shown in Figure 32, measures the colour developing that mechanism 7 monitors (monitoring) reagent paper 18 by this, judges collection blood whether (the step S403 of Figure 32).
In step S403, when the voltage of signals value of importing from the photo detector 72 of measuring mechanism 7 surpasses predefined ultimate value, be judged as and gathered blood, when above-mentioned magnitude of voltage is lower than predefined ultimate value, is judged as and does not gather blood.
Above-mentioned ultimate value is set at: compare very greatly with the above-mentioned voltage of signals value before making reagent paper 18 colour developing, and the above-mentioned voltage of signals value during with colour developing is compared very little.
In above-mentioned steps S403, be judged as under the situation of not gathering blood, whether judgement time arrives (the step S404 of Figure 32).
In above-mentioned steps S404, under the situation about not arriving in the time of being judged as, return step S403, the later processing of implementation step S403 once again is being judged as under the situation that time is up, carries out Error processing (the step S405 of Figure 32).
In step S405, stop pump 8, open electromagnetic valve 26, remove above-mentioned decompression state, simultaneously, there is the situation of error to show at for example display part 12, perhaps report by audio output unit 32 usefulness sound.Self-evident, reporting of this error also can be carried out with display part 12 and audio output unit 32 both sides.
Operator's (user) reports according to this error, can hold the situation (any trouble) of error.
In addition, in above-mentioned steps S403, be judged as under the situation of having gathered blood, stopping pump 8 (the step S406 of Figure 32).
Then, open electromagnetic valve 26, remove inner cavity 52 decompression state (the step S407 of Figure 32) of (comprising in the perforator 13).
In case open electromagnetic valve 26, exogenous QI (atmosphere) will flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210 through pipe 82,81 and vent path 54, makes inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure (with reference to Figure 31).
Eliminated and returned atmospheric pressure if confirm as the attraction sense at peripheral position of the site of puncture 210 of finger tip 200, just made finger tip 200 leave the abutment 163 of perforator 13.
(6) after having implemented step S407 shown in Figure 32, controlling organization 11 is by measuring the colour developing degree that mechanism 7 measures above-mentioned reagent paper 18, carry out the revisals such as revisal calculating of calculation process, temperature revisal calculating, hematocrite value according to resulting data, make blood glucose value quantification (the step S408 of Figure 32).
In this case, owing to removed inner cavity 52 decompression state of (comprising in the perforator 13), be the decompression state of the spatial accommodation of reagent paper 18, so, can supply with the glucose (composition that will measure) in the above-mentioned blood 220 fully and remain on composition (for example oxygen, carbon dioxide, steam etc.) in the needed atmosphere of reaction of reagent of reagent paper 18, thus, can more correctly measure blood glucose value.
Then, show above-mentioned blood glucose value of calculating (the step S409 of Figure 32) at display part 12.
Thus, can hold blood glucose value.
In addition, in above-mentioned steps S407, after removing decompression state, prepare the mensuration of next time, close electromagnetic valve 26 once more.
As indicated above, according to this body fluid composition measuring apparatus 1, can gather the blood of measuring needed and abundant amount at short notice reliably, simultaneously, can be correctly and measure blood glucose value (amount of the given composition in the blood) reliably.
In addition, owing in perforator 13, be provided with reagent paper 18, so the collection and the scattering, measuring on reagent paper 18 (quantification of composition) of puncture, blood can be carried out continuously, so, be easy to carry out at short notice the mensuration (composition measurement) of blood glucose value.
Moreover, be easy to carry out beamhouse operation in use, therefore, also more favourable for the situation of regular use or situation about using repeatedly.
The accident on live body surface etc. has improved safety in case can prevent to puncture once again mistakenly after the puncture.And, owing to can directly not see puncture needle 14, so, the fear when also having alleviated puncture.
From as can be seen above-mentioned, this body fluid composition measuring apparatus 1 is suitable for situation about using when patient oneself measures self blood glucose value etc.
In addition, this body fluid composition measuring apparatus 1 simple in structure, small-sized, light weight, cheap is so also be applicable to mass production.
In addition, as shown in figure 33, in this form of implementation, though adopted the structure that (time t1) punctures before the driving of pump 8 begins, but, in the present invention, for example also can adopt with the driving of pump 8 roughly (time t2) or (time t3) punctures after the driving of pump 8 begins structure simultaneously.In other words, in the present invention, can puncture during for atmospheric pressure, can also when this pressure is first pressure P 1, puncture at the pressure of inner cavity 52 (containing in the perforator 13).
Below, second form of implementation of body fluid composition measuring apparatus of the present invention is described.
Figure 34 is the skiagraph of the major part configuration example of expression body fluid composition measuring apparatus second form of implementation of the present invention.In addition, omit, difference mainly is described with the explanation of the common ground of the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.In addition, in Figure 34, be " cardinal extremity " with the right side, the left side describes for " front end ".
The different formations that are pressure regulating mechanism of this second form of implementation body fluid composition measuring apparatus 1 and the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
That is to say that as shown in figure 34, this body fluid composition measuring apparatus 1 is provided with tubule 83, replaces the electromagnetic valve 26 of the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
Tubule 83 is made of cylinder-like part, and its inside is formed with throttling (stream) 831.The engaged at end (connection) of this tubule 83 and pipe 82, the front end of tubule 83 (throttle orifice 831) opens wide towards the outside of body 21.
The throttle orifice 831 of this tubule 83 is made thin gauge structure, so the resistance ratios that air passes through is bigger.The diameter of this throttle orifice 831 is not particularly limited, still, and for example if the degree of 0.01～0.3mm is relatively good.In addition, also there is no particular limitation for the length of throttle orifice 831, still, if the degree of 1～15mm is relatively good.Be taken in the above-mentioned scope by diameter, can obtain the resistance of necessary sufficient air by (circulation) with throttle orifice 831.
Constitute the decompression cancel system by means of above-mentioned pipe (stream) 81,82 and tubule 83, constitute pressure regulating mechanism by this decompression cancel system and pump 8.
In addition, tubule 83 is not limited to illustrated structure, and its number that number or throttle orifice are set can be as required for a plurality of.
When this body fluid composition measuring apparatus 1 was gathered blood from the site of puncture, based on the information from pressure transducer 27, the driving of control pump 8 to reducing pressure in the inner cavity 52 (comprising in the perforator 13), made its pressure change (variation) in time.
In addition, the pressure patterns in the inner cavity 52 when gathering above-mentioned blood comprise decompression time, and pressure can change in time, but are not particularly limited.Below, an one example is described.
The curve chart of the pressure pattern when Figure 35 is expression collection blood in the inner cavity 52.
As shown in the drawing, when gathering blood with above-mentioned body fluid composition measuring apparatus 1, the driving of control pump 8 with subatmospheric first pressure P 1 that once reduces pressure of the pressure in the inner cavity 52, afterwards, increases this pressure lentamente.
Thus, can in shorter time, gather the blood of measuring needed abundant amount reliably.
In addition, the degree that above-mentioned first pressure P 1 is got 300～600mmHg is relatively good, preferably the degree of 400～600mmHg.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
The pressure of above-mentioned inner cavity 52 is that the degree of 100～300mmHg/sec is relatively good from gather way (pumping rate) of first pressure P 1, preferably the degree of 200～250mmHg/sec.
Therefore, can in shorter time, gather the blood of measuring needed abundant amount more reliably.
Moreover above-mentioned pumping rate can at random be set according to the number that number or throttle orifice 831 are set of for example tubule 83, to the adjusting of the diameter of throttle orifice 831.
Utilize this body fluid composition measuring apparatus 1, since the flow of the air that the driving of pump 8 attracts greater than (more than) flow of the exogenous QI (atmosphere) that flows into from the throttle orifice 831 of tubule 83, so, during driving pump 8, the attraction of the air in the inner cavity 52 of housing 5 begins, whereby, making the pressure of inner cavity 52 (comprising in the perforator 13) is first pressure P 1.That is to say that inner cavity 52 (comprising in the perforator 13) becomes decompression state.
Then, in case pump 8 is stopped, exogenous QI will be through throttle orifice 831, pipe 82,81 and the vent path 54 of tubule 83, flow into inner cavity 52 (comprising in the perforator 13) and site of puncture 210, the pressure of inner cavity 52 (comprising in the perforator 13) increases lentamente from first pressure P 1, thus, remove the decompression state of inner cavity 52 (comprising in the perforator 13) and site of puncture 210.In other words, inner cavity 52 (comprising in the perforator 13) and site of puncture 210 return atmospheric pressure.
In addition, as shown in figure 35, (time t1) before puncture can begin in the driving of pump 8, any time of (time t3) carries out after roughly the driving of (time t2) and pump 8 begins simultaneously with the driving of pump 8.In other words, can puncture during for atmospheric pressure, can also puncture during for decompression state in inner cavity 52 at the pressure of inner cavity 52 (containing in the perforator 13).
The pressure of above-mentioned inner cavity 52 can also can change (variation) for necessarily in time from gather way (pumping rate) of first pressure P 1.
In addition, body fluid composition measuring apparatus 1 can only have the once circulation (circulation shown in Figure 35) that the pressure with above-mentioned inner cavity 52 once becomes subatmospheric first pressure P 1, afterwards this pressure increased lentamente, also can have repeatedly circulation.
According to this body fluid composition measuring apparatus 1, can obtain the effect same with the body fluid composition measuring apparatus 1 of above-mentioned first form of implementation.
More than, along with the body fluid composition measuring apparatus that Third Way of the present invention has been described according to illustrated each form of implementation.But the present invention is not limited to this, and for example the formation of each one can be replaced into the formation arbitrarily that can bring into play same function.
In addition, the present invention also can suitably make up the given formation of above-mentioned each form of implementation.
In above-mentioned form of implementation, be illustrated with the representative of blood as the body fluid of gathering, still, in the present invention, the body fluid of collection is not limited to this, for example, also can be perspiration, lymph fluid, bone marrow fluid etc.
In addition, in above-mentioned form of implementation, as the composition of measuring purpose, with glucose (blood glucose value) is that representative is illustrated, but, the present invention for example, also can be inorganic ionss such as albumen, cholesterol, uric acid, creatine class amide, ethanol, sodium etc. being not limited to this aspect the composition of measuring purpose.
In addition, in above-mentioned form of implementation,, still, in the present invention, measure the character that mechanism also can measure given composition, in addition, can also measure the amount and the character of given composition as measuring the amount that mechanism is used for measuring given composition.
In addition, in above-mentioned form of implementation, be also used as the blood collection testing agency of detecting blood collection and the mechanism that measures the mensuration mechanism of the amount of given composition in the blood (in form of implementation, this mechanism being called " measuring mechanism ") though be provided with, but, blood collection testing agency also can be set respectively in the present invention and measure mechanism.
In above-mentioned form of implementation, as blood collection testing agency, though what use is the mechanism of detecting blood collection with optical mode,, the present invention is not limited to this, also can use other the mechanism of for example detecting with electric means.
In addition, in the present invention, under the situation of the blood collection testing agency that uses the collection that detects blood with optical mode, be not limited to detect the colour developing (color development) of reagent paper of the reaction of composition in the above-mentioned blood and reagent, also can detect the importing situation of other the blood of for example blood being supplied with to the reagent paper of perforator towards blood access (blood pathway).
Detecting the occasion of blood to the importing situation of blood access, also can adopt following structure, for example form near the position of the blood access at least in the perforator with parts with light transmission (transparent), by means of blood collection testing agency, light is shone to this blood access, make reflected light or see through light to be subjected to light, carry out light-to-current inversion, by means of the voltage of controlling organization monitoring by the output of above-mentioned blood collection testing agency.With blood when above-mentioned blood access imports, the color at this position roughly is changed to reddish black, therefore, change from the reflected light at this position or the light quantity that sees through light, change from the voltage of above-mentioned blood collection testing agency output, with the detection of the variation of this output voltage (light quantity), can carry out the detection of blood collection.
Detect the blood collection testing agency of blood collection as above-mentioned with electric means, can use the pick off (electrode), biosensor of the impedance that for example detects (mensuration) perforator blood access etc. etc.
State in the use under the situation of biosensor, for example, when blood imported to above-mentioned blood access, the electric current of exporting from this biosensor changed, and therefore, utilizes the detection of the variation of this output current (current value), just can carry out the detection of blood collection.
In addition, under the situation of using the pick off that detects above-mentioned impedance, for example, when above-mentioned blood access imported, the impedance between this sensor electrode changed, and therefore, utilizes the detection of the variation of this impedance, just can carry out the detection of blood collection with blood.
Moreover, body fluid composition measuring apparatus of the present invention is by the reaction of composition in the above-mentioned blood and reagent, measure the colored intensity of the reagent paper of (colour examining) colour developing with optical mode, and to measured value conversion, demonstration, but, be not limited to this, for example, also can measure the potential change of giving birth to, convert, show to measured value with electric means according to the composition volume production in the corpse or other object for laboratory examination and chemical testing.
In above-mentioned form of implementation, adopted the structure of before measuring, removing decompression state, but also can adopt the structure that before measuring, relaxes decompression state in the present invention.
In addition, in the present invention, the driving of puncture mechanism and pressure regulating mechanism also can be respectively manually to begin or to begin automatically.
In addition, in the present invention, perforator 13 courts that make housing 5 and be contained on the housing 5 also can be set keep out of the way mechanism away from the mobile perforator of direction (proximal direction) of finger.This perforator keep out of the way mechanism can be with above-mentioned first or each form of implementation of the present invention of second mode in the same structure with symbol 61 explanations.
Further, in the present invention, early stage, the body fluid composition measuring apparatus 1 of first mode also can be to comprise the pressure detecting mechanism that second mode stipulates and the mode of notifying operator, or comprised the mode of pressure regulating mechanism of (25) regulation of Third Way, can also be the mode that comprises this two side.
Be additional to each mechanism of first mode, same with each form of implementation explanation of second mode and Third Way omits its repeat specification here.
Briefly, in first mode, its body fluid composition measuring apparatus is also to be provided with the notifying operator that is used to detect the pressure detecting mechanism of above-mentioned spatial accommodation pressure and reports given information, and pass through the above-mentioned mechanism of decompressor to above-mentioned spatial accommodation examination decompression, based on information from above-mentioned pressure detecting mechanism, the body fluid composition measuring apparatus of the formation of reporting by above-mentioned notifying operator.
Perhaps, in first mode, its body fluid composition measuring apparatus also is the body fluid composition measuring apparatus that also has the pressure regulating mechanism of the spatial accommodation pressure of regulating above-mentioned puncture needle.
Further, be provided with the pressure detecting mechanism that is used to detect above-mentioned spatial accommodation pressure and report the notifying operator of given information and by the above-mentioned mechanism of decompressor to above-mentioned spatial accommodation examination decompression, based on the body fluid composition measuring apparatus of first mode of the formation of reporting from the information of above-mentioned pressure detecting mechanism, by above-mentioned notifying operator, can also be body fluid composition measuring apparatus with pressure regulating mechanism of the spatial accommodation pressure that is used to regulate above-mentioned puncture needle.
Industrial application
As indicated above, according to the present invention, can provide a kind of when gathering blood (for example, from When blood is gathered in the site of puncture), can (for example carry out body fluid just definitely reliably at short notice Blood) body fluid composition measuring apparatus of the mensuration of given composition in.
Particularly, the epidermis that punctures redundantly can be prevented, thus, patient's burden can be alleviated.
In addition, be provided with the occasion of pressure regulating mechanism, because to space (for example, puncture needle Spatial accommodation) reduce pressure, and this pressure is changed in time, therefore, can be in the short time In gather to measure reliably the blood of needed and abundant amount, and then, can be at short notice Carry out reliably the mensuration of given composition in the body fluid.
Be provided with at puncture outfit in the situation of test paper, can puncture continuously, blood Gather and scattering, measuring on the test paper (quantification of composition), easy and can be in short-term Between in carry out the mensuration of body fluid components.
Since be easy to carry out beamhouse operation in use, therefore, for the feelings of regular use The situation of condition or Reusability is also more favourable.
The accident on live body surface etc. has improved in case can prevent from puncturing once again mistakenly after the puncture Security. And, owing to can directly not see puncture needle, so, when also having alleviated puncture Fear.
Can find out that from above-mentioned this body fluid composition measuring apparatus is suitable for patient oneself and measures self blood Situation about using when the sugar value waits.
In addition, this body fluid composition measuring apparatus is simple in structure, small-sized, light weight, cheap, so Also be applicable to a large amount of productions.
Claims (10)
1, a kind of body fluid composition measuring apparatus is to install the body fluid composition measuring apparatus that uses behind the perforator with puncture needle and reagent paper, it is characterized in that,
Above-mentioned perforator with above-mentioned puncture needle and reagent paper also has housing, and above-mentioned reagent paper is configured in the peripheral part of above-mentioned housing, has the contact site that contacts with the epidermis of site of puncture at the front end of above-mentioned housing, has opening in the inboard of above-mentioned housing;
Above-mentioned body fluid composition measuring apparatus comprises:
The stopper section that the epidermal patch of puncture is leaned on;
Be used to keep the spatial accommodation of above-mentioned perforator;
Drive described puncture needle, abut in the puncture mechanism of the epidermis on the described stopper section with puncture;
The epidermis site of puncture that makes described puncture needle is with the spatial accommodation of the described perforator mechanism of decompressor for decompression state;
Be used for measuring from the mensuration mechanism of the amount of the given composition of the body fluid collection of described site of puncture, that scatter at described reagent paper;
Be used to detect the biological fluid extracting testing agency of the collection of described body fluid; And
The decompression cancel system of the decompression state of the spatial accommodation of releasing or the described at least reagent paper of mitigation,
And adopt such formation: when detecting the collection of described body fluid by described biological fluid extracting testing agency, remove or relax the decompression state of the spatial accommodation of described at least reagent paper by described decompression cancel system, afterwards, measure the amount of given composition in the body fluid of described collection by described mensuration mechanism.
2, according to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that, in described mensuration, need the given composition in the atmosphere.
According to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that 3, described decompression cancel system has stream that is communicated with described spatial accommodation and outside and the valve that opens and closes this stream.
According to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that 4, described decompression cancel system has the stream that is communicated with described spatial accommodation and outside, this stream its part at least has the bigger part of resistance ratios that air passes through.
According to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that 5, at least a portion of at least a portion of described mensuration mechanism and described biological fluid extracting testing agency is mutual dual-purpose.
According to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that 6, the decompression state of the intravital described spatial accommodation of described shell is removed or relaxed to described decompression cancel system.
According to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that 7, the driving of described puncture mechanism and the driving of the described mechanism of decompressor begin substantially simultaneously.
8, according to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that described reagent paper is the reagent paper that blood sugar detection is used.
9, according to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that, also comprise:
Be used to detect the pressure detecting mechanism of the pressure of described spatial accommodation; And
Be used to report the notifying operator of given information,
To described spatial accommodation examination decompression, when described pressure detecting mechanism did not detect the decompression state of above-mentioned spatial accommodation, described notifying operator was reported and is mistake by the described mechanism of decompressor.
10, according to the body fluid composition measuring apparatus of claim 1 record, it is characterized in that, also comprise the pressure regulating mechanism of the spatial accommodation pressure that is used to regulate above-mentioned puncture needle,
And adopt such formation: during from described site of puncture collection of body fluids, described spatial accommodation is reduced pressure, and this pressure is changed in time by described pressure regulating mechanism.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP225936/2000 | 2000-07-26 | ||
| JP2000225936A JP4493172B2 (en) | 2000-07-26 | 2000-07-26 | Component measuring device |
| JP248778/2000 | 2000-08-18 | ||
| JP248777/2000 | 2000-08-18 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB018163521A Division CN1275572C (en) | 2000-07-26 | 2001-07-26 | Body fluid composition measuring apparatus |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101095614A CN101095614A (en) | 2008-01-02 |
| CN100563563C true CN100563563C (en) | 2009-12-02 |
Family
ID=18719639
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006100997330A Expired - Fee Related CN100563563C (en) | 2000-07-26 | 2001-07-26 | Body fluid composition measuring apparatus |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP4493172B2 (en) |
| CN (1) | CN100563563C (en) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100356893C (en) | 2002-07-01 | 2007-12-26 | 泰尔茂株式会社 | Body fluid sampling device |
| CN1665447A (en) * | 2002-07-02 | 2005-09-07 | 爱科来株式会社 | Unit for piercing, and piercing device |
| EP1726259B1 (en) * | 2004-03-15 | 2011-10-05 | Terumo Kabushiki Kaisha | Body fluid collecting device |
| US20080124693A1 (en) * | 2006-10-26 | 2008-05-29 | Mcevoy Mary | System for determining an analyte in a bodily fluid sample that includes a graphics-based step-by-step tutorial module |
| JP5157567B2 (en) * | 2008-03-25 | 2013-03-06 | パナソニック株式会社 | Blood analyzer |
| CN104622516A (en) * | 2015-02-28 | 2015-05-20 | 耿秀英 | Body fluid sampling test storage device for endocrinology departments |
| WO2016188430A1 (en) * | 2015-05-25 | 2016-12-01 | Coyote Bioscience Co., Ltd. | Devices and methods for sample collection cross-reference |
| CN107920789A (en) * | 2015-05-25 | 2018-04-17 | 卡尤迪生物科技宜兴有限公司 | Apparatus and method for sample collection |
| CN107849508A (en) | 2015-07-13 | 2018-03-27 | 卡尤迪生物科技（北京）有限公司 | Apparatus and method for sample collection |
| CN108844565A (en) * | 2018-08-31 | 2018-11-20 | 四川沃文特生物技术有限公司 | A kind of needle arm structure puncturing function with anticollision |
| CN111671434B (en) * | 2020-06-03 | 2023-04-25 | 首都医科大学附属北京天坛医院 | Blood sugar monitoring integrated device |
| CN112155679B (en) * | 2020-10-28 | 2021-10-12 | 王冬冬 | Gynaecology's chamber mirror minimal access surgery scalpel |
| CN112370054B (en) * | 2020-12-30 | 2023-07-18 | 贵州大学 | Blood glucose meter and automatic blood glucose measurement method |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000014662A (en) * | 1998-01-22 | 2000-01-18 | Terumo Corp | Humor examination device |
| JP3668382B2 (en) * | 1998-11-19 | 2005-07-06 | テルモ株式会社 | Component measuring device |
-
2000
- 2000-07-26 JP JP2000225936A patent/JP4493172B2/en not_active Expired - Fee Related
-
2001
- 2001-07-26 CN CNB2006100997330A patent/CN100563563C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JP4493172B2 (en) | 2010-06-30 |
| CN101095614A (en) | 2008-01-02 |
| JP2002034956A (en) | 2002-02-05 |
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