CN100473339C - Needle-insertion device - Google Patents

Needle-insertion device Download PDF

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Publication number
CN100473339C
CN100473339C CNB2003801058245A CN200380105824A CN100473339C CN 100473339 C CN100473339 C CN 100473339C CN B2003801058245 A CNB2003801058245 A CN B2003801058245A CN 200380105824 A CN200380105824 A CN 200380105824A CN 100473339 C CN100473339 C CN 100473339C
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China
Prior art keywords
cylindrical portion
skin
sting device
pressure
internal pressure
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CN1725979A (en
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松本大辅
小室秀文
坂田哲也
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Arkray Inc
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Arkray Inc
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Abstract

This invention relates to a lancing apparatus (A 1 ) used for inserting an insertion element ( 21 ) into a human skin (Sk) for sampling a body fluid. The lancing apparatus (A 1 ) includes a housing ( 1 ) with a cylindrical portion ( 12 ) brought into contact with the skin (Sk), a negative pressure generator ( 6 ) that generates a negative pressure inside the cylindrical portion ( 12 ) to cause the skin (Sk) to swell upward, and a detector ( 5 ) that detects that the skin (Sk) has been raised to a predetermined height inside the cylindrical portion ( 12 ).

Description

Sting device
Technical field
The present invention relates at the body fluid of taking blood etc. or when organizing, be used for sting device the broken skin of acupuncture.
Background technology
When the treatment diabetics, will measure concentration of glucose as sample from the blood that the patient takes on one's body, decide treatment policy etc. according to this measured value.As the prior art of the sting device that is used for this purposes, have in the technology shown in Figure 18 of present patent application A and (for example open communique 2001-No. 346781 with reference to the spy of Japan.)
Sting device 9 shown in this Fig can dispose lancet 91 progressively in the shell of the cylindrical portion 90 with front opening.Cylindrical portion 90 has the structure of flange part 93 that is formed with the hole portion 92 of minor diameter in central authorities, disposes glucose concentration determination device 94 in the outstanding mode of a part in this hole portion 92.In addition, this sting device 9 has the unshowned electrodynamic pump of figure, constitutes to form negative pressure in cylindrical portion 90 by driving this electrodynamic pump.
In this sting device 9, under front end and s skin S k state of contact, electrodynamic pump is driven and cylindrical portion 90 under the situation of generation negative pressure, s skin S k heaves in cylindrical portion 90 in cylindrical portion 90.The heaving to contact with flange part 93 by s skin S k of s skin S k is prevented from.On the other hand, lancet 91 drives, advances automatically through behind the certain hour from electrodynamic pump, and Sk makes s skin S k hemorrhage by this forward motion prick skin.At this moment, from the effusive blood of s skin S k, because of the effect of negative pressure promoted flow out on one side, in glucose concentration determination device 94, taked on one side.Therefore, in sting device 9, both can reduce the puncture amount of lancet 91, can flow out the blood of measuring the concentration of glucose aequum again.
But, because sting device 9 with after driving the electrodynamic pump certain hour, lancet 91 is automatically constituted, so following unfavorable condition can take place to the progressive mode of s skin S k.
That is, in sting device 9, electrodynamic pump only drives certain hour, not necessarily can be to s skin S k effect target negative pressure.For example, abominable when the contact condition of 90 couples of s skin S k of cylindrical portion, between cylindrical portion 90 and s skin S k, exist under the situation in gap, air can flow into the inside of cylindrical portion 90, makes the inside of cylindrical portion 90 can not form suitable negative pressure state.In addition, even cylindrical portion 90 inside have reached the target negative pressure, but because the flexibility difference of s skin S k, the amount of heaving of s skin S k also has very big difference.
So, in sting device 9, for example exist between cylindrical portion 90 and the s skin S k under the harder situation of gap or s skin S k, shown in Figure 18 B, s skin S k sometimes can not heave fully.Before under this state, making lancet 91 and then during prick skin Sk, can cause that lancet 91 does not arrive s skin S k and can not puncture or cause the insufficient problem of amount of bleeding owing to its paracentesis depth is more shallow.
On the other hand, under the softer situation of s skin S k, though s skin S k can heave fully by negative pressure, but, like that, a part of Sk1 of s skin S k might contact with flange part 93 with stronger pressure, thereby causes the oppressed problem of this part s skin S k1 shown in Figure 18 C.The compressing of this s skin S k (Sk1) is to cause the main cause that reduces from the amount of bleeding of site of puncture.In addition, like that, a part of Sk2 of s skin S k might enter in the cave portion 92 because of the effect of negative pressure, and is perhaps bulging above it very greatly shown in the symbol of this figure.In this case, paracentesis depth is dark excessively, and the damage that puncture brings for s skin S k is big, can bring very big pain to user.
Summary of the invention
The objective of the invention is to: under the situation about after utilizing negative pressure that skin is heaved, puncturing, can not be subjected to the influence of skin hardness, the action of puncturing suitably.
By sting device provided by the invention is to be used to make the piercing element prick skin to come to take from skin the sting device of body fluid, comprising shell and be used to make the inside of described cylindrical portion to produce the sting device that negative pressure makes the negative pressure generation part that skin heaves to have and be used for detection of skin and heave detection part in the inside of described cylindrical portion to setting height with the cylindrical portion that is used for contacting skin.
The negative pressure generation part for example is made of electrodynamic pump.Certainly, can use manual pump as the negative pressure generation part.
Sting device of the present invention preferably also has control assembly, heaves to setting height when detecting skin by described detection part, is used for internal pressure with described cylindrical portion and maintains control in the particular range.Above-mentioned sting device constitutes the pressure detecting part that for example also has the internal pressure that is used to detect cylindrical portion.In this case, control assembly constitutes based on be used for internal pressure with cylindrical portion by the detected pressure of pressure detecting part and maintains control in the particular range.
Here, particular range is set to the scope that has certain width apart from reference pressure.Reference pressure preferably is set to, than when the internal pressure that detects the cylindrical portion of skin when heaving by detection part to setting height low.In addition, the higher limit and the lower limit of particular range preferably are set to, than when the internal pressure that detects the cylindrical portion of skin when heaving by detection part to setting height low.
Detection part also can constitute the change of the bulge height that can detect skin.In this case, control assembly constitutes, and the mode that maintains set condition with the state of heaving with skin is controlled the internal pressure of cylindrical portion.Detection part for example constitutes to have when skin is heaved to setting height and the contact component of contact skin.In this case, detection part preferably constitutes and detects the contact force of skin when contacting with this contact component, and control assembly preferably constitutes, so that contact force maintains the internal pressure that mode in the particular range is controlled cylindrical portion.
Control assembly for example constitutes, and the internal pressure of controlling cylindrical portion by the driving of carrying out the negative pressure generation part maintains in the particular range.Control assembly constitutes, and the open and close controlling by the relief valve on the part that is arranged on the inside that is communicated with cylindrical portion maintains the internal pressure of cylindrical portion in the above-mentioned particular range.In this case, control assembly for example constitutes, and when identical or approximate when identical in the higher limit of the internal pressure of cylindrical portion and above-mentioned particular range, opens relief valve.Can use known various valve as relief valve.
Sting device of the present invention preferably also has auxiliary space, after the inside that makes cylindrical portion by the negative pressure generation part produces negative pressure, when the higher limit of the internal pressure of cylindrical portion and above-mentioned particular range is identical or approximate when identical, be used to make the internal gas of cylindrical portion to flow into.This auxiliary space for example constitutes and can reduce pressure by the negative pressure generation part.
Sting device of the present invention preferably also has gas and flows into alternative pack, is controlled and is used to select gas inflow auxiliary space and does not flow into the state of auxiliary space by control assembly.In this case, sting device preferably also has the pressure detecting part that the cylindrical portion of the internal pressure that is used to detect cylindrical portion is used, gas flow into alternative pack be based on the pressure detecting part that cylindrical portion uses testing result and by the relief valve of open and close controlling.Relief valve in this case can use known various valve.
Sting device of the present invention constitutes the pressure detecting part that the auxiliary space that also has the pressure that is used to detect auxiliary space is used.In this case, above-mentioned sting device preferably constitutes detected pressures at the pressure detecting part that auxiliary space is used and becomes than predetermined threshold value under the big situation, utilizes the negative pressure generation part auxiliary space that reduces pressure.
Sting device of the present invention also can constitute in the inside of cylindrical portion and be provided with the installation portion that is used for removably installing acquisition elements, and wherein, above-mentioned acquisition elements is used for gathering from the effusive body fluid of skin by skin is punctured.Acquisition elements for example constitutes and comprises analyzer.
The cylindrical portion of shell is made from multiple components, and preferably constitutes and the part in those parts can be unloaded from other parts.
Sting device of the present invention preferably also has control assembly, based on the internal pressure that is detected the cylindrical portion of skin when heaving to setting height by detection part, controls the puncture speed of piercing element to the paracentesis depth or the piercing element of skin.
Description of drawings
Fig. 1 is the sectional view of the sting device of expression first embodiment of the invention.
Fig. 2 is the amplification sectional view of the pith of Fig. 1.
Fig. 3 is the axonometric chart of an example of expression sensor holder.
Fig. 4 A is the axonometric chart that expression is installed in the assembled state of the example of biosensor on the sensor holder, and Fig. 4 B is the biosensor exploded perspective view shown in Fig. 4 A.
Fig. 5 is the sectional view of the user mode of sting device shown in Figure 1.
Fig. 6 is the amplification sectional view of the pith of Fig. 5.
Fig. 7 is the flow chart of cylindrical portion pressure inside control that is used to illustrate the control part of sting device shown in Figure 1.
Fig. 8 is the chart of the example of expression cylindrical portion internal pressure variation.
Fig. 9 is the amplification sectional view of pith of the sting device of expression second embodiment of the invention.
Figure 10 is the flow chart of cylindrical portion pressure inside control that is used to illustrate the control part of sting device shown in Figure 9.
Figure 11 is the chart of example of variation of pushing loading that is used to illustrate the loading detecting sensor of sting device shown in Figure 9.
Figure 12 is the amplification sectional view of pith of the sting device of expression third embodiment of the invention.
Figure 13 is the amplification sectional view of pith of the sting device of expression four embodiment of the invention.
Figure 14 is the sectional view of the sting device of expression fifth embodiment of the invention.
Figure 15 is the sectional view of the sting device of expression sixth embodiment of the invention.
Figure 16 is the sectional view of the sting device of expression seventh embodiment of the invention.
Figure 17 is the sectional view of the sting device of expression eighth embodiment of the invention.
Figure 18 A~Figure 18 C is the sectional view of pith of an example of the existing sting device of expression.
The specific embodiment
What Fig. 1 and Fig. 2 represented is the sting device of first embodiment of the invention.As shown in Figure 1, sting device A1 has: shell 1, the lancet support 2A that is used to keep lancet 2, the installation portion 4 that is used for sensor installation support 3, sense switch 5, pressure transducer 53, pump 6, control part 7 and other aftermentioned parts.
Shell 1 has the form of two sleeve 10A, 10B being connected with the approximate circle tubular, in the pars intermedia and top of N1 in the drawings, N2 direction, is covered by outer box 80.The part of the close front end of this shell 1 is the cylindrical portion 12 that is formed with peristome 11, and when using this sting device A1, the front end of barrel 12 contacts with the s skin S k of human body.
Sleeve 10A has 10a of first and second portion 10b.The 10a of first supports the movable body 50 of aftermentioned sense switch 5, can freely load and unload with respect to second portion 10b.According to such formation, for example on movable body 50, paying dirt etc. and when needing to clean, shown in this figure dummy line, like that, by the 10a of first is taken off from second portion 10b, and can make things convenient for and suitably movable body 50 is cleaned.In addition, under the state that unloads the 10a of first, can also be at an easy rate to cleaning in the second parts 10b.
Shell 1 is provided with link stopper 13, is used for contacting with the flange part 23 of lancet support 2A when lancet support 2A carries out forward motion, limits the forward motion of lancet support 2A with this.This link stopper 13 is performed element 85 and supports, can freely change the position on N1, N2 direction by executive component 85.That is, select the position of link stopper 13 by making executive component 85 actions, thereby can adjust the forward stroke of lancet support 2A and even lancet 2, can adjust paracentesis depth to s skin S k.
Lancet 2 has the form that metal needle 21 is given prominence to from plastic head 20.Lancet support 2A makes lancet 2 move to the N1 of the front end of shell 1 direction under the state that keeps lancet 2.This lancet support 2A constitutes the inside that can reciprocatingly be housed in shell 1 along arrow N1, N2 direction, after locking shell 1, carries out forward motion by removing this locking-in state.
More particularly, lancet support 2A hangs on the notch part 19 of shell 1 lock pawl 22 by moving along arrow N2 direction, thereby is locked on the shell 1.Lancet support 2A can carry out to lancet support 2A pushing lancet 2 time simultaneously to moving of arrow N2 direction.Certainly, lancet support 2A also can separate with the action to lancet support 2A pushing lancet 1 to the locking of shell 1 and carries out.
As shown in Figure 5, under the state that pins lancet support 2A, when the block 81 that makes operation usefulness when arrow N1 direction moves, the pusher 83 of the usefulness that unlocks advances while compressing spring 82, thereby removes the state that tangles between lock pawl 22 and the notch part 19.Therefore, the elastic force by spring 82 makes lancet support 2A advance with lancet 2, makes the pin 21 of lancet 2 pierce through to s skin S k.The flange part 23 that the advancing of lancet support 2A is performed until lancet support 2A can not progressive mode limit its stroke with till the link stopper 13 of shell 1 contacts according to surpassing these.Formed the spring 84 that returns usefulness when lancet support 2A advances and be compressed, the elastic force of the spring that returns usefulness 84 that retreats immediately after advancing according to lancet support 2A makes lancet support 2A retreat suitable size.Therefore, the pin 21 of lancet 2 can be extracted from s skin S k.
Pump 6 is the air-breathing and deflated electrodynamic pumps that can carry out air, is set on the position of latch housing 1 of inside of outer box 80.The air entry 60 of this pump 6 is connected with intercommunicating pore 14 on the sidewall that is arranged on shell 1, can produce negative pressure in the inside of cylindrical portion 12 by driving this pump 6.Produce under the situation of negative pressure making under the state of barrel 12 and contact skin, suction function makes s skin S k heave to the inside of cylindrical portion 12 on s skin S k.This pump 6 is for example driven by the unshowned battery of figure.
Installation portion 4 is to be used for the part of sensor installation support 3 removably, comprises the plastic adnexa 40 on the inwall that is fixed on cylindrical portion 12.Sensor holder 3 is used for biological support pick off 3A, is Bullet structure.Lancet 2 and biosensor 3A are Bullet structure too.
Biosensor 3A shown in Fig. 4 A and Fig. 4 B like that, constitute the surface with substrate 390 be provided with contain with blood in glucose take place certain reaction (for example oxidation reaction) enzyme the 39a of reagent portion and be used for the electric pair of electrodes 39b that detects its degree of reaction.Stackedly on substrate 390 be provided with separated by a certain interval and a pair of dividing plate of arranging 391 and the cover plate 392 that covers this a pair of dividing plate 391 form capillary tube 393 by them.On substrate 390 and each dividing plate 391, be formed with recess 394 continuously as the blood introducing port.On biosensor 3A, when paying in recess 394 under the situation of blood, blood is advanced in capillary tube 393 by capillarity, and is directed into the 39a of reagent portion.
As Fig. 2 and as shown in Figure 3, sensor holder 3 is that synthetic resin is made, and has main part 32 and is circular-arc side wall portion 31 from the cross section that this main part 32 erects upward.The bottom of main part 32 forms skewed, and pick off 34 is connected with this part.This sensor holder 3 can loading and unloading on installation portion 4 freely by the peristome 11 of cylindrical portion 12.More particularly, as Fig. 2 institute represents well, installation portion 4 have below open space part 41, the side wall portion 31 by making sensor holder 3 enters its inside from the below of this space part 41, and makes sensor holder 3 be supported by the pushing force F of spring 42.Sensor holder 3 also can freely be taken off the joint elements that close and realizes with respect to the support of installation portion 4 by being provided with on sensor holder 3 and installation portion 4.
On installation portion 4, maintain the N1 along shell 1, a pair of mensuration probe 43 that the N2 direction is extended.But a mensuration probe 43 only draws on drawing.These mensuration probe 43 break-through are arranged on the pair of holes 32a on the sensor holder 3 and can be connected with the pair of electrodes 39b of biosensor 3A.That is, a pair of mensuration probe 43 can apply voltage and measure electric current biosensor 3A.The current value of being measured by a pair of mensuration probe 43 in control part 7 described later, the basis when being imported into the concentration of glucose of blood of capillary tube 393 (with reference to Fig. 4 A) of biosensor 3A as calculating.
Sense switch 5 is set at the inside of cylindrical portion 12, has the movable body 50 and the carriage 52 that are provided with switch terminal 51a, 51b respectively.The axle 52a that movable body 50 constitutes by carriage 52 supports rotationally, makes the shift in position of switch terminal 51a.This movable body 50 has downward conical surface 50b.
In this sense switch 5, as Fig. 5 and as shown in Figure 6, when s skin S k in cylindrical portion 12 when arrow N2 direction is heaved, movable body 50 rotates in the mode that takes up upward by s skin S k.Therefore, the switch terminal 51a of movable body 50 is moved upward, and this switch terminal 51a contacts with the switch terminal 51b of carriage 52.Its result, sense switch 5 becomes to be opened, and such signal of opening is imported in the control part 7.In addition, because movable body 50 has conical surface 50b, so under the situation that s skin S k heaves, s skin S k contacts equably with the inclined plane of the conical surface 50b and the bottom surface sections of sensor holder 3 is approximate.
Pressure transducer 53 is used to detect the internal pressure of cylindrical portion 12, is configured in the inside of cylindrical portion 12.Carry the data of detected pressures to control part 7 from this pressure transducer 53.
Control part 7 for example constitutes the memorizer that has CPU and be attached to it, is configured on the suitable position in the outer box 80.This control part 7 constitutes based on opening signal and by the detected pressure data of pressure transducer 53, carrying out the driving control of pump 6 described later or the Position Control of block 13 from sense switch 5.In addition, this control part 7 is based on by measuring the current value that probe 43 is measured, and is imported into the calculating of concentration of glucose of blood of the capillary tube 393 (with reference to Fig. 4 A) of biosensor 3A.
In sting device A1, though omit on drawing, externally the surface element of box 80 etc. is provided with the display device of for example being made up of liquid crystal display, shows the glucose concentration value that is calculated by control part 7 in this display device.On this sting device A1, also be provided with the console switch (omitting diagram) of the operations such as switch switching of the power supply that is used to carry out control part 7 or pump 6.
Next, in conjunction with an example of the control action of control part shown in Figure 77 order, the effect of sting device A1 is described.
Using sting device A1 to carry out under the situation of s skin S k puncture, at first, as Fig. 1 and as shown in Figure 2, to the human body skin Sk pushing cylindrical portion 12 as the puncture object, then, operation aforesaid operations switch drives pump 6.Thereby, produce negative pressure and s skin S k heaved in the inside of cylindrical portion 12.
On the other hand, in control part 7, judgement sense switch 5 opens or cuts out (S1).As mentioned above, sense switch 5 is heaved when a certain amount of for opening at s skin S k.Therefore, can judge that by judging switch 5 to open or close (S1) s skin S k heaves a certain amount of or do not have.
Judge that when control part 7 sense switches 5 are not (S1:NO) under the situation about opening, carry out the judgement of S1 repeatedly, till to judge sense switch 5 in control part 7 be to open (S1:YES).
Wherein, control part 7 also can not consider to repeat the S1 of certain number of times or after the judgement of beginning S1 through certain hour, but be not the judgement that stops S1 under the situation of opening (S1:NO) at sense switch 5, carry out fault processing.In this case, control part 7 preferably is presented at these contents in the display device, the control of perhaps sounding.So, user can be learnt that the contact of cylindrical portion 12 relative s skin S k is bad and can not make suction function to s skin S k, thereby can avoid no matter s skin S k heaves or do not heave the generation with regard to the such problem of skin puncture Sk.
Control part 7 is judging sense switch 5 under the situation of opening (S1:YES), and for the internal pressure with cylindrical portion 12 is maintained within a certain range, decision is as the pressure inside scope (S2) of the cylindrical portion 12 of controlled target.In S2, at the front and back of decision pressure limit decision paracentesis depth.
For example, pressure limit as shown in Figure 8, with than internal pressure P in sense switch 5 cylindrical portion 12 when opening ELow slightly any pressure (20~30gf/cm for example 2) be reference pressure P S, with only than this reference pressure P SThe low pressure and the highly compressed first threshold P of low or high appropriate value 1And the second threshold value P 2Pressure limit as the border.Preferably with first threshold P 1And the second threshold value P 2Be set at internal pressure P than sense switch 5 cylindrical portion 12 when opening ELow value.
On the other hand, the decision of the degree of depth is based on the pressure in the pressure transducer 53 detected cylindrical portion 12, is undertaken by the position of decision block 13.That is, control part 7 with the paracentesis depth of the low more then lancet 2 of detected pressures just dark more mode drive executive component 85 block 13 moved.
Under the situation that adopts the formation of adjusting paracentesis depth according to detected pressures, can obtain following effect.That is, usually, have the hard more then hemorrhage few more tendency of skin from the amount of bleeding of the puncture of skin part, on the other hand, hard more then being difficult to more of s skin S k heaves.Its on the other hand, in sting device A1, the internal pressure of sense switch 5 cylindrical portion 12 when opening is that the hard more then pressure of skin is low more.So,, then can not be subjected to the influence of s skin S k hardness, and make the amount of bleeding when puncturing approximate impartial if detected pressures low more (s skin S k is hard more) improves the paracentesis depth to s skin S k more.
Such effect also can be by adopting according to skin hardness, being detected pressures P E(with reference to Fig. 8) changes the structure of puncture speed and obtains.More particularly, constitute when heaving when set amount makes sense switch 5 become the state of opening because of negative pressure by s skin S k, control part 7 is with reference at that time by the detected pressure P of coming of pressure transducer 53 E(with reference to Fig. 8) is with this pressure P E(with reference to Fig. 8) low more (s skin S k is hard more), the pace more slow mode of lancet 2 when puncture controlled.If the paracentesis depth of s skin S k is the same, in general, the pace of lancet 2 is slow more, and then the wound of the puncture of s skin S k part is big more, and it is many that liquid outlet quantity just becomes.So, for according to detected pressures P E(with reference to Fig. 8) adjusts the structure of puncture speed, also can make liquid outlet quantity not be subjected to the influence of s skin S k hardness and homogenization.
Wherein, as the device that is used to change lancet 2 paces, for example can use to have when lancet 2 advances and the parts of lancet 2 or lancet support 2A sliding-contact, and can change the device of the frictional force when their sliding-contacts.
Control part 7 judges that whether internal pressure by pressure transducer 53 detected cylindrical portion 12 is than first threshold P under the situation of decision pressure limit and paracentesis depth (S2) 1Low (S3).Control part 7 is judging that detected pressures is than first threshold P 1Under the low situation (S3:YES), the driving of pump 6 is stopped (S4).The built-in pressure ratio first threshold P that can suppress thus, cylindrical portion 12 1Low Duo and make s skin S k be subjected to exceeding the compressing of desired value than desirable value.In addition, control part 7 is judging that detected pressures is unlike first threshold P 1Under the situation of low low pressure (being high pressure) (S3:NO), make pump 6 continue to drive.
Next, control part 7 is judged the detected pressures and the second threshold value P 2Whether compare is high pressure (S5).This S5 is used to detect producing minim gap after the driving that stops pump 6 between cylindrical portion 12 and s skin S k, air flows into the situation of cylindrical portion 12 inside by this gap, that is, be used to detect the internal pressure rising of cylindrical portion 12 and the amount of heaving of s skin S k is reduced to more than the essential value.
When control part 7 is judged the detected pressures and the second threshold value P 2Be in a ratio of under the situation of high pressure (S5:YES), make pump 6 drive (S6).Therefore, can eliminate the negative pressure deficiency of cylindrical portion 12 inside, the amount of heaving of s skin S k is suitably changed.On the other hand, judging the detected pressures and the second threshold value P when control part 7 2Be in a ratio of under the situation of low pressure (than the second threshold value P 2Low) (S5:NO), make the driving of pump 6 keep closed condition.
Next, control part 7 judges whether the control of cylindrical portion 12 pressure inside finishes (S7).That is, control part 7 need to judge whether the internal pressure of control cylindrical portion 12, and whether the operation of for example puncturing finishes.Then, judging the control of cylindrical portion 12 pressure inside when control part 7 does not have under the end situation of (needing to control the internal pressure of cylindrical portion 12) (S7:NO), control part 7 carries out the judgement of S2~S7 repeatedly, till being judged as the internal pressure (S7:YES) that does not need to control cylindrical portion 12.
Preferred control part 7 is reported its content when carrying out the judgement of S1~S7.The report of its content for example can be undertaken by demonstration or sounding in display device.In this case, user can learn by the notice of confirming its content whether s skin S k suitably heaves.So, can see the opportunity that s skin S k suitably heaves as user, the cover plate 81 that bulldozing operation is used carries out the puncture of s skin S k.
Be punctured and from s skin S k under the hemorrhage situation, its blood is taken a sample by biosensor 3A at s skin S k.In biosensor 3A, in capillary tube 393 (with reference to Fig. 4 A), glucose in the blood and the 39a of reagent portion reaction.At this moment, if utilize a pair of mensuration probe 43 of sting device A1 between the pair of electrodes 39b of biosensor 3A, to apply voltage, then can come the current value of replying of assaying reaction glucose by a pair of probe 43.In control part 7, calculate concentration of glucose based on replying current value, its result for example shows in display device.So, in this sting device A1,, also have and calculate the function that shows concentration of glucose, so convenient for the user except the puncture function.
On the other hand, control part 12 there is no need to control in judgement under the situation of internal pressure of cylindrical portion 7 (S7:YES), closes the driving (S8) of pump 6, finishes the pressure inside control of cylindrical portion 12.
According to above-mentioned control, example as shown in Figure 8 is such, if begin driving pump at moment T1, then the pressure in the cylindrical portion 12 descends gradually after that.Next, at moment T2, make after sense switch 5 opens owing to s skin S k heaves fully, between the puncture release, the pressure in the cylindrical portion 12 are maintained at and clip reference pressure P SFirst threshold P 1With the second threshold value P 2Between.Thereby, before the puncture release, because the internal pressure of cylindrical portion 12 is maintained at (first threshold P in the certain limit 1With the second threshold value P 2Between), so the amount of heaving that can keep s skin S k is within the specific limits.
The internal pressure P of the cylindrical portion 12 when in addition, the first threshold P1 and the second threshold value P2 open based on sense switch 5 EAnd set pressure P EIt is the amount of heaving of the s skin S k value when reaching a certain amount of.That is pressure P, EIt is the soft degree of considering s skin S k in fact.Therefore, in sting device A1, pressure limit (the first threshold P that is controlled by control part 7 1With the second threshold value P 2Between) according to soft degree as puncture subject's skin Sk, and when each puncture action, be set, so be not subjected to the influence of the soft degree of s skin S k, the amount of heaving of the s skin S k during with puncture is maintained within a certain range.Therefore, in sting device A1, can always make the puncture amount of pin 21 remain on proper depth.Its result can avoid making its amount of heaving excessive because of s skin S k is soft, causes pin 21 skin puncture Sk more than the necessary degree of depth.In addition, opposite with it, also can avoid causing the quantity not sufficient that pierces through of pin 21 because of s skin S k makes its amount of heaving too small firmly.Certainly, because produce negative pressure in the cylindrical portion 12, so also can obtain the hemorrhage facilitation effect that causes owing to this suction function.Thus, in this sting device A1, can not need to bring bigger damage and obtain using biosensor 3A to measure the essential and sufficient amount of bleeding of concentration of glucose institute to s skin S k.
And, if the scope of the internal pressure of cylindrical portion 12 is set at internal pressure P than the cylindrical portion 12 of sense switch 5 when opening ELow, then the bulge height that s skin S k can be when opening sense switch 5 is low, and sense switch 5 maintains open mode.So, can avoid sense switch 5 to open repeatedly or close and allow user hear the sound bad ear.And above-mentioned pressure limit is set to, with the internal pressure P than sense switch 5 cylindrical portion 12 when opening ELow slightly any pressure (20~30gf/cm for example 2) be reference pressure P S, and with to this reference pressure P SThe first threshold P of only low or high appropriate value 1With the second threshold value P 2Be bounds.Therefore and since the power when s skin S k contact with movable body 50 and biosensor 3A a little less than, so can not make the deterioration that becomes of the blood circulation of its contact portion, so can not hinder the liquid outflow.
What Fig. 9~Figure 17 represented is other embodiments of the present invention.Wherein, in these figure, for or similar elements mark prosign identical with first embodiment, and the repetitive description thereof will be omitted.
What Fig. 9 represented is the sting device of second embodiment of the invention.In this sting device A2, sense switch 5 constitutes has load detection sensor 54.This load detection sensor 54 is set on the carriage 52, constitutes as s skin S k to heave and during by movable body 50 pushing, detect the load F1 of this moment.Certainly, load detection sensor 54 also can be set on the movable body 50.
Be imported into control part 7 (omitting in the figure) by these load detection sensor 54 detected load datas with reference to Fig. 1.The control part 7 of sting device A2 constitutes and carries out the approximate certain control of the state of heaving that following control is used as being used to make s skin S k.
Shown in the flow chart of Figure 10, control part 7 judging under the situation that load detection sensor 54 becomes out by movable body 50 pushings (S10:YES), and decision as the load range (between higher limit Fu shown in Figure 11 and the lower limit Fb) of controlled target (S11).In S11,, decide paracentesis depth according to output (according to the hardness of skin) from load sensor 54 in the front and back of decision load range.
On the other hand, control part 7 carries out the judgement of S10 repeatedly judging under the situation that load sensor 54 is not opened by movable body 50 pushings (S10:NO), till judgement load sensor 54 is opened by movable body 50 pushings (S10:YES).
Control part 7 monitors by the detected load of load sensor 54 under having determined as the situation of the load range of controlled target (S11), judges whether this load has surpassed higher limit Fu (with reference to Figure 11) (S12).Control part 7 stops the driving (S13) of pump 6 judging under the situation that detection load surpassed higher limit Fu (with reference to Figure 11) (S12:YES).
Control part 7 is (S13) under the situation that the driving that makes pump 6 stops, and perhaps judging detection load above (S12:NO) under the situation of higher limit Fu (with reference to Figure 11), judges whether detection load does not reach lower limit Fb (with reference to Figure 11) (S14).At this moment, control part 7 is being judged under the situation that detection load do not reach lower limit Fb (with reference to Figure 11) (S14:YES), pump 6 is driven after, judge whether the internal pressure control of cylindrical portion 12 finishes, whether for example judge that puncture is moved finishes (S16).The judgement of this S16 is in control part 7, carries out (S14:NO) judging under the situation that detection load do not reach lower limit Fb (with reference to Figure 11).
Control part 7 repeats the judgement of S11~S16 under the situation that the internal pressure control of judging cylindrical portion 12 does not have to finish (S16:NO).In addition, control part 7 is closed the power supply (S17) of pump 6 under the situation that the internal pressure control of judging cylindrical portion 12 finishes (S16:YES).
Power that load detection sensor 54 is pushed by movable body 50 and the state of heaving of s skin S k are closely related, and in addition, the state of heaving of this s skin S k and the internal pressure of cylindrical portion 12 are closely related.Therefore, can be by based on the driving of the pump 6 that carries out from the output of load detection sensor 54 control, s skin S k heaved control within the specific limits.Promptly, as shown in figure 11, when moment T1, begin the driving of pump 6, then, according to heaving at moment T2 of s skin S k, load detection sensor 54 is pushed and opens by movable body 50, then, by the negative pressure in the control cylindrical portion 12, by load detection sensor 54 detected loads by folding and unfolding in the certain limit that is determined by higher limit Fu and lower limit Fb.
According to present embodiment, also can not be subjected to the influence of s skin S k flexibility, and the state of heaving that makes the s skin S k when puncturing is approximately necessarily, and is identical with previous embodiment, can be suitably to the pin 21 of s skin S k puncture lancet 2 and can be inexcessive or not enough.Usually, because load detection sensor is more cheap, so in the method for applied load detecting sensor,, suitably make skin heave the approximate certain control of state again, so be ideal because both reduced the whole cost of sting device.
What Figure 12 represented is the sting device of third embodiment of the invention.This sting device A3 is provided with sense switch 5 directly over installation portion 4, in addition, sensor holder 3 can lifting.That is, sting device A3 constitutes according to the heaving and rising sensor holder 3 of s skin S k, this moment sensor holder 3 pushing load detection sensors 54.
According to such sting device A3, because sensor holder 3 goes back double as and be used for the parts that detection of skin Sk heaves, so for the number that reduces device global facility, the miniaturization that reduces manufacturing cost and implement device is ideal.
What represent in Figure 13 is the sting device of four embodiment of the invention.This sting device A4 is arranged on relief valve 69 on the shell 1.It is connected state or connected state not that this relief valve 69 is used to select between cylindrical portion 12 inside and outside.Control switching by control part 7 (in Figure 13, omitting) with reference to Fig. 1.
In this sting device A4, during the internal pressure of control cylindrical portion 12, pump 6 is always driven, when reducing the internal pressure of cylindrical portion 12, make relief valve 69 be in closed condition, in addition, when the internal pressure that makes cylindrical portion 12 rises, make relief valve 69 be in open mode.Like this, do not need open and close controlling is carried out in the driving of pump 6, and only the open and close controlling by relief valve 69 just can be with the inner sustain of cylindrical portion 12 in the pressure limit as target.
What represent in Figure 14 is the sting device of fifth embodiment of the invention.The internal pressure that this sting device A5 has in cylindrical portion 12 becomes than desired value (the second threshold value P for example shown in Figure 8 2) when big, be used to reduce the auxiliary space 61 of the internal pressure of cylindrical portion 12.
This auxiliary space 61 has air vent 62 and air entry 63, and portion disposes the pressure transducer 64 of the pressure that is used to detect auxiliary space 61 within it.Air vent 62 is connected with pump 6, uses when discharging the air of auxiliary space 61.Air entry 63 is to use when the air that makes cylindrical portion 12 inside flows into auxiliary space 61, is connected with the intercommunicating pore 14 of shell 1 by managing 65.On pipe 65, dispose valve V, constitute by this valve V and can select auxiliary space 61 still not to be communicated with the internal communication of cylindrical portion 12.This valve V carries out open and close controlling according to the internal pressure of cylindrical portion 12, promptly by the pressure of pressure transducer 53 detections by control part 7.
Pump 6 is controlled driving by control part 7, use with the air of auxiliary space 61 when discharge the outside.That is, pump 6 is when s skin S k heaves or when the pressure that s skin S k heaves back auxiliary space 61 surpasses certain value and be driven.
In sting device A5, after making cylindrical portion 12 and s skin S k closely contacts, produce negative pressure by inside s skin S k is heaved in cylindrical portion 12.The generation of negative pressure is under the state that valve V is opened, and driving pump 6 ejects by air with the inside of auxiliary space 61 and cylindrical portion 12 and to carry out.If make auxiliary space 61 between the inside and pump 6 of cylindrical portion 12, then with the inner pressure relief of cylindrical portion 12 time, auxiliary space 61 has as soundproof spatial effect.Its result can suppress noise leakage that the driving because of pump 6 produces to outside.
Cylindrical portion 12 pressure inside are according to flow chart shown in Figure 7 and controlled.But, at the built-in pressure ratio second threshold value P of cylindrical portion 12 2When big, open valve V and make the air of cylindrical portion 12 inside flow into auxiliary space 61, with cylindrical portion 12 inner pressure relieves.In addition, control part 7 constitutes at the pressure of auxiliary space 61 and surpasses under the situation more than the certain value, pump 6 is driven and the pressure of auxiliary space 61 is maintained below the certain value.Therefore, the pressure inside difference of auxiliary space 61 and cylindrical portion 12 can be maintained more than the certain value, can make cylindrical portion 12 gas inside suitably flow into auxiliary space 61.
In this sting device A5, constitute not driving pump 6 all the time, but only when both sides' pressure of the inside of cylindrical portion 12 and auxiliary space 61 surpasses certain value, pump 6 is driven.So, need be for the internal pressure of keeping cylindrical portion 12 driving pump 6 within the specific limits and all the time, perhaps driving pump 6 continually.Its result in sting device A5, can suppress the noise and the vibration that produce because of driving pump 6, thereby can suppress to give the vibration of s skin S k and rocking at puncture hour hands 21.So, in sting device A5, can suppress in addition, can lower the puncture pain that brings mensuration person from the dispersing of the effusive blood of s skin S k.In addition,, then can suppress the power consumption of pump 6, in addition, can use the less pump of power ratio 6 if shortened the time of driving pump 6.Its result is using under the situation of battery as the power supply of pump 6, in the life-span that can keep its battery muchly, in addition, can reduce the size of device integral body by using the little pump 6 of size.
What represent in Figure 15 is the sting device of sixth embodiment of the invention.In this sting device A6, in sting device A5 shown in Figure 14, auxiliary space 61 is constituted as circulation flow path.That is, auxiliary space 61 constitutes the length of greatly guaranteeing the circulation flow path between cylindrical portion 12 and the pump 6.The auxiliary space 61 of performance said function also can be made of pipe.
What represent in Figure 16 is the sting device of seventh embodiment of the invention.The intercommunicating pore 14 that this sting device A7 connects auxiliary space 61 and cylindrical portion 12 is provided with relief valve 66.That is, sting device A7 adopts the structure of relief valve 66 to substitute the structure of combination sting device A5 shown in Figure 14 and pipe 65 and valve V.
In this sting device A7, identical with valve V (with reference to Figure 14), by by control part 7 control relief valves 66 and do not need driving pump 6 all the time, in addition, can not be subjected to s skin S k hardness influence and the amount of heaving of s skin S k is kept necessarily.
What represent in Figure 17 is the sting device of eighth embodiment of the invention.This sting device A8 constitutes the pressure control of the inside preliminary vacuum of carrying out cylindrical portion 12 respectively and post-decompression in the early stage cylindrical portion 12.
More particularly, connect by auxiliary space 61 and circulation flow path 61 ' between pump 6 and the cylindrical portion 12.At this moment, pump 6 is communicated with the air vent 62 of auxiliary space 61 and the air vent 62 ' of circulation flow path 61 ' respectively as having two air entries 60,60 ' structure.Then, the air entry 63 of auxiliary space 61 is provided with relief valve 66.
The present invention is not limited to the content of above-mentioned embodiment, and the concrete structure of the various piece of sting device of the present invention can freely carry out various design alterations.
In the present invention, checkout gear also can not be to use pressure-detecting device and the such formation of load detection sensor for the internal pressure that detects cylindrical portion.That is, checkout gear of the present invention for example also can use electro-optical pickoff or so-called touch sensor, also can use the so-called mechanical switch that becomes out when skin is heaved setting height.
In the present invention, also can adopt and do not carry out being used for heaving of skin maintained the such structure of certain control.For example, also can adopt by checkout gear to detect after skin heaves the height of setting, make lancet such formation of advancing at that time immediately.Even in this formation, also can make lancet that skin is carried out the puncture of appropriate amount, thereby reach purpose of the present invention.Under the situation that adopts this structure, can use the very simple switch of structure to heave the checkout gear of degree as detection of skin.
Depression generator of the present invention is not limited to electrodynamic pump.Though the use electrodynamic pump can allow the simple to operate of user, and the open and close with driving that can be by this electrodynamic pump carry out pressure controlled advantage,, also can use manual pump to substitute electrodynamic pump.
In addition, for example can adopt the method for utilizing electromagnetic force and Air Force to substitute the device that utilizes spring force and be used as being used to make the progressive device of lancet support.
Sting device of the present invention also can be used as the device with the analytic function that is used to analyze sampled reagent, perhaps also can constitute the installation function of the biosensor with the reagent that is used to take a sample.

Claims (20)

1. sting device is characterized in that:
It is to be used to make the piercing element prick skin to come to take from skin the sting device of body fluid, comprising shell and be used to make the inside of described cylindrical portion to produce the sting device that negative pressure makes the negative pressure generation part that skin heaves with the cylindrical portion that is used for contacting skin
Have and be used for detection of skin and heave to the mechanical switch of setting height or by the detection part that any pick off constituted that is selected from load detection sensor, electro-optical pickoff and touch sensor in the inside of described cylindrical portion.
2. sting device as claimed in claim 1 is characterized in that:
Also have control assembly, heave to setting height, be used for internal pressure with described cylindrical portion and maintain control in the particular range when detecting skin by described detection part.
3. sting device as claimed in claim 2 is characterized in that:
The pressure detecting part that also has the internal pressure that is used to detect described cylindrical portion, and,
Described control assembly constitutes based on by the detected pressure of described pressure detecting part, is used for internal pressure with described cylindrical portion and maintains control in the particular range.
4. sting device as claimed in claim 2 is characterized in that:
Described particular range is the scope that has specific width apart from reference pressure, and,
Described reference pressure is set to, than when the internal pressure that detects the described cylindrical portion of skin when heaving by described detection part to setting height low.
5. sting device as claimed in claim 4 is characterized in that:
The higher limit and the lower limit of described particular range are set to, than when the internal pressure that detects the described cylindrical portion of skin when heaving by described detection part to setting height low.
6. sting device as claimed in claim 2 is characterized in that:
Described detection part constitutes the change of the bulge height that can detect skin, and,
Described control assembly constitutes, and the mode that maintains set condition with the state of heaving with skin is controlled the internal pressure of described cylindrical portion.
7. sting device as claimed in claim 6 is characterized in that:
Described detection part constitutes to have when skin is heaved to setting height and the contact component of contact skin, detects the contact force of skin when contacting with this contact component simultaneously.
8. sting device as claimed in claim 7 is characterized in that:
Described control assembly constitutes, so that described contact force maintains the internal pressure that the interior mode of particular range is controlled described cylindrical portion.
9. sting device as claimed in claim 2 is characterized in that:
Described control assembly constitutes, and the internal pressure of controlling described cylindrical portion by the driving of carrying out described negative pressure generation part maintains in the described particular range.
10. sting device as claimed in claim 2 is characterized in that:
Also have the relief valve on the part that is arranged on the inside that is communicated with described cylindrical portion,
Described control assembly constitutes, and the open and close controlling by carrying out described relief valve maintains the internal pressure of described cylindrical portion in the described particular range.
11. sting device as claimed in claim 10 is characterized in that:
Described control assembly constitutes, and when when the higher limit of the internal pressure of described cylindrical portion and described particular range is identical, opens described relief valve.
12. sting device as claimed in claim 2 is characterized in that:
Also have auxiliary space, after the inside that makes described cylindrical portion by described negative pressure generation part produces negative pressure, when the higher limit of the internal pressure of described cylindrical portion and described particular range is identical, be used to make the internal gas inflow of described cylindrical portion.
13. sting device as claimed in claim 12 is characterized in that:
Also have gas and flow into alternative pack, controlled and be used to select gas to flow into described auxiliary space and do not flow into the state of described auxiliary space by described control assembly.
14. sting device as claimed in claim 13 is characterized in that:
Also have the pressure detecting part that the cylindrical portion of the internal pressure that is used to detect described cylindrical portion is used,
Described gas flow into alternative pack be based on the pressure detecting part that described cylindrical portion uses testing result and by the relief valve of open and close controlling.
15. sting device as claimed in claim 12 is characterized in that:
Described auxiliary space constitutes and can reduce pressure by described negative pressure generation part.
16. sting device as claimed in claim 15 is characterized in that:
Also have the pressure detecting part that the auxiliary space of the pressure that is used to detect described auxiliary space is used,
Constitute detected pressures at the pressure detecting part that described auxiliary space is used and become than predetermined threshold value under the big situation, utilize the described negative pressure generation part described auxiliary space that reduces pressure.
17. sting device as claimed in claim 1 is characterized in that:
Be provided with the installation portion that is used for removably installing acquisition elements in the inside of described cylindrical portion, wherein, described acquisition elements is used for gathering from the effusive body fluid of skin by skin is punctured.
18. sting device as claimed in claim 1 is characterized in that:
The cylindrical portion of described shell is made from multiple components, and constitutes and the part in those parts can be unloaded from other parts.
19. sting device as claimed in claim 1 is characterized in that:
Also have control assembly,, control the puncture speed of described piercing element the paracentesis depth or the described piercing element of skin based on the internal pressure that detects the described cylindrical portion of skin when heaving by described detection part to setting height.
20. sting device as claimed in claim 1 is characterized in that:
Described negative pressure generation part is made of electrodynamic pump.
CNB2003801058245A 2002-12-13 2003-12-11 Needle-insertion device Expired - Fee Related CN100473339C (en)

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JP362483/2002 2002-12-13
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EP1980204A4 (en) * 2006-01-31 2015-07-29 Panasonic Healthcare Holdings Co Ltd Blood test method and blood test apparatus
WO2007108518A1 (en) 2006-03-22 2007-09-27 Matsushita Electric Industrial Co., Ltd. Blood test apparatus and method of controlling the same
ATE507768T1 (en) * 2008-10-02 2011-05-15 Eyesense Ag IMPLANTATION DEVICE FOR METABOLITE SENSORS
JP2010233803A (en) * 2009-03-31 2010-10-21 Sysmex Corp Puncture instrument for forming micropore
CN105879184A (en) * 2016-04-01 2016-08-24 新乡医学院 Electronic writing device with examination anxiety resisting function

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