Summary of the invention
Therefore the objective of the invention is to alleviate the problems referred to above and realize uncomplicated solution thus, can detect the outbreak that the acute symptomatic blood pressure reduces at the still evitable time point of its any influence place by means of this solution.
According to an aspect of the present invention, the alert device by initial introduction reaches this purpose, and wherein pulse (pulse) recording equipment comprises pulse blood oxygen instrument, and it is suitable for registering pulse shape parameter based on the light response variations at least one blood vessel of main body.Control unit further comprises processing unit, and it is suitable for calculating initial pulse magnitude measure based on first pulse shape parameter that receives constantly, and is suitable in the storage device that initial pulse magnitude measure is stored in control unit is associated.During first the measurement after constantly in (period), processing unit is suitable for calculating each pulse magnitude measures based in a plurality of pulse shape parameter that receive each.In addition, be each pulse magnitude during measuring, processing unit is suitable for investigating this measurement and whether reaches criterion with respect to initial pulse magnitude measure.If find to reach this standard, then this processing unit is suitable for producing the alarm trigger signal.Therefore, can be automatically and/or manually adopt adequate measure to avoid (or reducing risk at least) hypotension to take place.
The significant advantage of this design is and can provides early stage hypotension alarm based on the pick off of comparing very little processing resource and simple and low-cost high-efficiency.In addition, this pick off of use is approved in medical range, and is had the functional of fine installation.
The preferred embodiment of this aspect according to the present invention, this processing unit are suitable for criterion is considered as reaching, if: the checked pulse magnitude measures of given pulse shape parameter is lower than the threshold values that calculates based on initial pulse magnitude measure; And the pulse magnitude measures of the scheduled volume of pulse shape parameter (such as 50-100%) is lower than threshold values, and this pulse shape parameter receives in test period after given pulse shape parameter.
Preferably, test period is to extend to the interval of selecting about 15 minutes scope from about 3 minutes, and more preferably, test period approximately be 5 minutes long.Therefore, according to threshold values, the pulse magnitude measures that reaches the required scheduled volume of criterion and the test period length of selection, can obtain reliable and stable hypotension alarm for the main body of great changes and application.
Another preferred embodiment of this aspect according to the present invention, this processing unit is suitable for by the normalization initial pulse magnitude measure, and calculates threshold values with predefined denominator except that normalized initial pulse magnitude measure, and this predefined denominator is for example from about 1.2 values of selecting to about 5 the scope.Therefore, by selecting threshold values, can come calibration algorithm to obtain required balance between alarm and the false alarm in early days about the length of test period.But, the general big relatively denominator short test period of need comparing, vice versa.
The another preferred embodiment of this aspect according to the present invention, it is that the pulse shape parameter that receives is arbitrarily calculated pulse magnitude measures that processing unit is suitable for during measuring by remove original measurement with initial pulse magnitude measure, and wherein initial pulse magnitude measure is represented the normalization initial pulse magnitude measure that the denominator of scheduled justice removed.Thereby, can there be inclined to one side comparison with original state.
Other preferred embodiment of this aspect according to the present invention, this equipment comprises ARU auxiliary recorder unit, it is suitable for registering repeatedly the bio-impedance parameter of the blood capillary shrinkage degree that shows main body.In addition, this processing unit is suitable for receiving bio-impedance parameter and investigates bio-impedance parameter whether reach the auxiliary alarm standard.And when reaching this standard, this processing unit is suitable for producing the alarm trigger signal.Therefore, provide complementary hypotension detection means and more reliable functioning is provided thus.
Another preferred embodiment of this aspect according to the present invention, this device are suitable for predicting that the intravital quick symptomatic blood pressure of the master who stands haemodialysis reduces.Here, the processing unit pulse shape parameter that is suitable for receiving in starting stage based on haemodialysis is calculated initial pulse magnitude measure.Therefore, hypotension detection is based on and is not treated the reference value that influences relatively.This has further strengthened reliability.
According to a further aspect in the invention, the medical system of the haemodialysis by being suitable for executive agent realizes this purpose.Except the warning devices that proposes above, this system comprises the dialysis machine of the extracorporeal blood treatment that is suitable for executive agent.Thereby, can monitor with plain mode Parallel Implementation haemodialysis and hypotension.
According to a further aspect in the invention, realize this purpose by the method for originally introducing, wherein the registration of pulse shape parameter relates to the pulse blood oxygen measurement.Thus, determine pulse shape parameter based on the light response variations at least one blood vessel of main body.In addition, this method comprises based on first pulse shape parameter that constantly receives calculates initial pulse magnitude measure, and this initial pulse magnitude measure is stored in the storage device.During first the measurement after constantly, calculate each pulse magnitude measures based in a plurality of pulse shape parameter that receive each.For each pulse magnitude measures in during measuring, investigate this measurement and whether reach criterion with respect to initial pulse magnitude measure, and if then produce the alarm trigger signal.
According to the above-mentioned introduction with reference to the warning devices that is proposed, the advantage of this method and preferred embodiment thereof are conspicuous.
According to other aspects of the invention, realize this purpose by the computer program that directly can be loaded into the internal storage of computer, described computer program comprises software, and this software is used to control the method for above-mentioned proposition when described program is moved on computers.
According to a further aspect in the invention, realize this purpose by the computer-readable medium with record program thereon, program is the method that is used to make the above-mentioned proposition of computer control here.
By following explanation and claims, other advantage of the present invention, favorable characteristics and application will be conspicuous.
The specific embodiment
We are earlier with reference to figure 1, and it describes to be used to according to an embodiment of the invention predict thealert device 100 of quick symptomatic blood pressure reduction in the main body P.Equipment 100 comprisespulse recording equipment 110 and 115 andcontrol unit 120 respectively.
The pulse recording equipment has pulseblood oxygen instrument 110, and preferably has independent sensor unit 115.Thisunit 115 comprises at least one light source and at least one photo-detector, by photo-detector pulse signal S is registered, pulse signal S (for example is connected to main body P part according tosensor unit 115, in finger, tongue, ear-lobe, nose or other end, in its skin or in the skin of any other body part) light response variations at least one blood vessel in theperipheral body part 105 of main body P described.Light response variations preferably reflects from the variation of the absorption aspect of the light of described at least one light emitted.But, can light reflex and/or the light transmission study equally well.In any case, pulseblood oxygen instrument 110 all is suitable for registering pulse shape parameter P based on pulse signal SPS
Control unit 120 is suitable for receiving and handling pulse shape parameter PPSParticularly,control unit 120 comprisesprocessing unit 128, and it is suitable for first moment t1The pulse shape parameter P that receivesPSBe stored in the storage device 123.Storage device 123 or be included in thecontrol unit 120, perhaps for example coupled via cable or wireless connections.In any case,processing unit 128 all is suitable for calculating initial pulse magnitude measure PM1 based on the value of storage in thestorage device 123.
Fig. 3 b illustrates the initial pulse magnitude measure PM1 about first main body that is exposed to extracorporeal blood treatment.Preferably, initial pulse magnitude measure PM1 is not only by single pulse shape parameter PPSDraw, but also based on the meansigma methods of a plurality of this parameters of registering during the initial measurement and draw.Curve chart among Fig. 3 b with a minute express time t, and is represented pulse magnitude measures PM along vertical axis along trunnion axis.
According to the present invention,processing unit 128 can be determined pulse magnitude measures PM via one or more following strategies.For example, can calculate the pulse shape parameter P that registers during the pulse strokePSMaximum and minima poor.Alternatively, can for example detect pulse shape parameter P by calculating Hilbert transformPSEnvelope.Also can be based on pulse shape parameter PPSUtilize root-mean-square (RMS) to measure and determine pulse magnitude measures PM.Yet this needs in advance parameter value to be calibrated to zero-mean.
It is respectively the systolic blood pressure variable BP of first main body during the treatment of unit with mmHg that Fig. 3 a illustratessWith diastolic blood pressure variable BPDCurve chart.Blood pressure BP runs through therapeutic process and changes.But, shown in Fig. 3 b, hypotension does not take place.The slight decline in therapeutic process about 245 minutes, it is steady relatively that pulse magnitude measures PM also keeps.
At first moment t1(that is, begin from t=0 here) during the measurement afterwards,processing unit 128 is suitable for the pulse shape parameter P based on a plurality of receptionsPSIn each calculate each pulse magnitude measures PM.Be each the pulse magnitude measures PM in during measuring,processing unit 128 is further adapted for investigation and measures PM and whether reach criterion with respect to initial pulse magnitude measure PM1.If find to have reached this criterion, thenprocessing unit 128 is suitable for producing the alarm trigger signal alpha.Infer the alarm trigger signal alpha conversely in thealarm unit 125 ofcontrol unit 120 self and/or alarm A is triggered.Introduce pulse magnitude measures PM and criterion in detail below with reference to Fig. 4,5 and 6.
Fig. 2 illustrates the block diagram of themedical system 200 of the haemodialysis that is used for executive agent P according to an embodiment of the invention.For this purpose,system 200 comprisesdialysis machine 210, and it can be suitable for the extracorporeal blood treatment of executive agent P, that is,machine 210 is suitable for extracting contaminated blood β out from main body PCAnd the blood β that will purifyPReturn to mainbody P.System 200 also comprises above-mentionedalert device 100, and being used for prediction is potential unsound blood pressure reduction fast arbitrarily to main body P.Therefore, in the blood that purifies main body P,alert device 100 is monitored the risk that his/her takes place about acute symptomatic hypotension.Under the situation of alarm signal α, avoid hypotension situation thereby can notify follow-up work personnel and/or dialysis machine can controlledly be used to regulate its treatment parameter.This adjusting is by 210 feedback signal alpha characterizes fromalert device 100 to dialysis machine.
Preferably, control unit 120 (referring to Fig. 1) in thealert device 100 is suitable for predicting that based on initial pulse magnitude measure PM1 the quick symptomatic blood pressure among the main body P reduces, the pulse shape parameter P that the haemodialysis of this initial pulse magnitude measure PM1 when also not being subjected to this treatment relatively in main body and influencing received in the starting stagePSCalculate.
Get back to Fig. 4 a now, the curve chart example is illustrated in systolic pressure BP during the extracorporeal blood treatment as can be seenSWith diastolic pressure BPDHow the figure that changes with per second mmHg.Time point t in treatment about 145 minuteshThe place, subject suffers from acute symptomatic hypotension.This incident is by systolic pressure BPSWith diastolic pressure BPDQuick reduction BP among both predicts.
Further with reference to figure 4b, how we will explain how the pulse magnitude measures PM and the separating of threshold values T and these parameters of calculating proposition according to the embodiment of the invention are used to predict the hypotension incident now.
Theprocessing unit 128 of Fig. 1 is suitable for investigating the pulse shape parameter P about receiving in during measuringPSWhether reach criterion.In this example, start from t=0 during the measurement, and run through interval during this period continuously by the figure covering of Fig. 4 a and 4b.
Theprocessing unit 128 ofcontrol unit 120 is preferably as follows and calculates threshold values T.At first, to time t1The initial pulse magnitude measure PM1 that (that is, t=0) here located to obtain carries out normalization.PM1=1 in this example, but say that technically other reference value all is imaginabale arbitrarily.The denominator of the scheduled justice of normalized then value removes, and this predefined denominator can be any number between 1.2 and 5, such as 2.Therefore, obtain threshold values T.Thereby, suppose that predefined denominator is 2, then T becomes 0.5, as by a dotted line shown in Fig. 4 b.During the measurement after t1,processing unit 128 is by (it is by first moment t with initial pulse magnitude measure PM11The pulse shape parameter P that receivesPSDraw) remove original amplitude measurement and be the pulse shape parameter P of each receptionPSCalculate normalized pulse magnitude measures PM.Therefore, the expression ratio is at first moment t1The pulse shape parameter P that receivesPSThe bigger pulse magnitude measures PM of pulse magnitude cause pulse magnitude measures PM>1, otherwise and, expression is than first t constantly1The pulse shape parameter P that receivesPSThe littler pulse magnitude measures PM of pulse magnitude cause pulse magnitude measures PM<1.
When drawing pulse magnitude measures PM,processing unit 128 thinks that above-mentioned criterion meeting reaches, if:
(a) the checked pulse magnitude measures PM of given pulse shape parameter is lower than threshold values T; With
(b) the pulse shape parameter P of the scheduled volume that after given pulse shape parameter, in test period tau, receivesPSPulse magnitude measures PM be lower than threshold values T.
According to one embodiment of present invention, scheduled volume is the pulse shape parameter P that receives in the expression test period tauPSAbout 50% to about 100% the value of pulse magnitude measures PM.Scheduled volume can be represented the pulse shape parameter P that receives in the test period tauPSWhole pulse magnitude measures PM.Yet, interrupt for fear of the single pulse magnitude measures PM that is higher than threshold values T, advantageously scheduled volume can be distributed into and be equivalent to less than 100%.Alternatively, second threshold values can be distributed into and be higher than threshold values T a little, andprocessing unit 128 can adopt hysteresis algorithm, in case thereby pulse magnitude measures PM drops under the threshold values T, if also do not surpass second threshold values at test period tau expiration place pulse magnitude measures PM, then think to reach criterion.
In the example shown in Fig. 4 b, drop on for the first time under the threshold values T at pulse magnitude measures PM about t=128 minute.Here, we suppose that above-mentioned scheduled volume is 100%, and test period tau be 5 minutes long.Therefore, test period tau finished about t=133 minute.But at this time point place, pulse magnitude measures PM surpasses threshold values T once more.Therefore,processing unit 128 will not produce the alarm trigger signal.
About t=135 minute, pulse magnitude measures PM turns back to the level that is lower than threshold values T, and this moment pulse magnitude measures PM keep below threshold values T during surpass test period tau (being 5 minutes) here.Thereby, when test period tau finishes (, approximately locating in t=140 minute), processing unit produces the alarm trigger signal alpha.So up to t=thWhen hypotension takes place, also surplus about 5 minutes.Therefore, by means of the alarm trigger signal alpha, can carry out suitable artificial and/or automatic hypotension within the scheduled time and stop action.If more advantageously processingunit 128 is suitable for being lower than at pulse magnitude measures PM any time generation attention (amber light on the unit is lighted) of threshold values T.Therefore, the staff of supervision can both obtain the possible the earliest indication that acute symptomatic hypotension may occur arbitrarily, and therefore needs the additional attention main body.If when pulse magnitude measures PM rises above threshold values T end, also do not reach criterion, then attention signal lost efficacy.
Certainly, according to the present invention, the test period tau length that is different from 5 minutes is imaginabale equally.In fact, test period tau can represent to extend to from about 3 minutes the selected arbitrary time span of about 15 minutes scope.The length of test period tau is to obtain the selected design parameter of required balance between stability and the reliability.Preferably, combine with above-mentioned predefined denominator and select test period T.That is, for the given balance between early stage hypotension alarm and the false alarm, big relatively denominator needs relatively short test period, and vice versa.
In addition, if in the example of Fig. 4 b, the pulse magnitude measures PM that reaches the required scheduled volume that is lower than threshold values T of criterion has been selected as the value less than 100%, such as 60%, then the alarm trigger signal alpha produces when first test period tau (that is, about t=133 minute) is expired.
Be similar to Fig. 4 a and 4b, Fig. 5 a and 5b illustrate the blood pressure of the 3rd main body in the illustration extracorporeal blood treatment process and the curve chart that corresponding pulse magnitude measures changes respectively.
In this example, main body is respectively at t=tH1Place's (in therapeutic process about 155 minutes) and t=tH2Place's (in therapeutic process about 178 minutes) suffers the acute symptomatic hypotension incident twice.In order to promote to compare with above-mentioned example, we here also select t1The initial pulse magnitude measure PM1 that place (t=0) obtains normalizes to 1, select threshold values T=0.5 (that is, predefined denominator is 2), and the length of test period tau is set to 5 minutes.In addition, if the pulse shape parameter P that receives in the test period tauPSWhole pulse magnitude measures PM drop under the threshold values T, then we think and reach criterion.
As it is evident that in the figure in Fig. 5 b, given these parameter values, thenprocessing unit 128 will be respectively at t=tα 1(in the therapeutic process about 145 minutes) and t=tα 2(in the therapeutic process about 171 minutes) locates to produce the alarm trigger signal alpha.Therefore shifting to an earlier date about 7 to 10 minutes provides the prediction that the hypotension incident takes place.
Get back to Fig. 3 b for the time being, we see that pulse magnitude measures PM never falls under the threshold values T (being 0.5) here.Therefore, in this case,processing unit 128 will not produce any alarm trigger signal alpha.
We get back to Fig. 1 now.According to one embodiment of present invention,equipment 100 comprises ARUauxiliary recorder unit 130, and it is suitable for registering repeatedly the bio-impedance parameter P of the blood capillary shrinkage degree of representing main body PBIIn this embodiment,processing unit 128 is further adapted for and receives this bio-impedance parameter PBI, and investigation parameter PBIWhether reach the auxiliary alarm standard.If find to reach this standard, thenprocessing unit 128 is suitable for producing the alarm trigger signal alpha.Thereby the Performance And Reliability ofequipment 100 is improved.For the usability offurther improvement equipment 100, irrelevant with the blood capillary contraction of main body P in fact if ARUauxiliary recorder unit 130 is suitable for determining bio-impedance parameter, then be preferred.Therefore, ARUauxiliary recorder unit 130 can be registered the variation of absolute body temperature, body temperature and/or the quantity of perspiration on the main body P, tests the auxiliary alarm standard and processing unit is suitable for contrasting one or more these parameters.
In order to sum up, below with reference to the common method of the flow chart introduction among Fig. 6 according to the quick symptomatic blood pressure reduction of prediction in main body of the present invention.
Whetherfirst step 610 investigation have received the pulse shape parameter about the peripheral body part of main body.If also do not receive this parameter, then program cycle is gone back and is rested on step 610.But if received pulse shape parameter, thenstep 620 is followed, and it calculates initial pulse magnitude measure based on first pulse shape parameter that receives constantly.Supposition has here been registered pulse shape parameter by the pulse blood oxygen measurement, wherein changes to determine pulse shape parameter based on the light absorption at least one blood vessel of main body.
Step 630 subsequently is stored in initial pulse magnitude measure in the storage device.After this, then be thatstep 640 is calculated each pulse magnitude measures based on each pulse shape parameter that receives in this period during the measurement.In addition, be each pulse magnitude measures in during measuring, whether thestep 650 investigation pulse magnitude measures after thestep 640 reaches criterion with respect to initial pulse magnitude measure.If find not reach criterion, and still effective during the hypothesis measurement, and then program cycle is got back tostep 640.
But, if instep 650, find to have reached criterion, then to follow bystep 660, it produces the alarm trigger signal.After this, program can finish, or is circulated back to step 640 (still effective during supposing to measure).Preferably, lost efficacy during the measurement, for example pressed SR with the response artificial interference.That is, even measuring under the situation that to be forced to interrupt thus, also directly restart for example to have fallen from main body P during (or actual maintenance) measurement owing to sensor unit 115.In this case, can connectsensor unit 115 simply again, measure afterwards and continue.
The above-mentioned all processing steps of introducing with reference to figure 6 and the anyon program of step can be controlled by the computer equipment of programming.In addition, although the above-mentioned embodiments of the invention of introducing with reference to the accompanying drawings comprise the program of carrying out in computer equipment and the computer equipment, but therefore the present invention also extends to computer program, particularly is applicable on the carrier that the present invention is put into practice or the computer program in the carrier.Program can have source code, object code, code intermediate source and for example part and compile the form of the object code of form, or has the enforcement of being applicable to any other form according to program of the present invention.Carrier can be can be program-carried any entity or equipment.For example, carrier can comprise storage medium, for example flash memory, ROM (read only memory), for example CD (compact disc) or quasiconductor ROM, EPROM (Erasable Programmable Read Only Memory EPROM), EEPROM (Electrically Erasable Read Only Memory) or for example magnetic recording medium of floppy disk or hard disk.In addition, carrier can be missile carrier, for example can or pass through radio or pass through electricity or the optical signal that other means are transmitted via electricity or optical cable.When program is embedded into can be by cable or miscellaneous equipment or device directly in the signal of transmission the time, carrier can be made of this cable or equipment or device.Alternatively, carrier can be that program embeds integrated circuit wherein, and this integrated circuit is suitable for the execution carrying out relative program or be used for relative program.
The term that uses in this description " comprises/comprise " feature, integer, step or the assembly of the statement that is used for illustrating appearance.But this term is not got rid of appearance or is increased one or more further features, integer, step or assembly or its combination.
The embodiment that the invention is not restricted to introduce among the figure, but can freely change within the scope of the claims.