CN201085809Y - Mechanical diuresis and natriuretic device implemented by extracorporeal circulation from periphery vein to vein - Google Patents

Mechanical diuresis and natriuretic device implemented by extracorporeal circulation from periphery vein to vein Download PDF

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Publication number
CN201085809Y
CN201085809Y CNU200720173862XU CN200720173862U CN201085809Y CN 201085809 Y CN201085809 Y CN 201085809Y CN U200720173862X U CNU200720173862X U CN U200720173862XU CN 200720173862 U CN200720173862 U CN 200720173862U CN 201085809 Y CN201085809 Y CN 201085809Y
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blood
pipeline
ultrafiltrate
pump
protector
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冯新庆
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Beijing Heartcare Medical Technology Co., Ltd.
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冯新庆
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Abstract

Disclosed is a water and sodium retention alleviating device which is realized through the extracorporeal circulation of the peripheral vein to the vein. The utility model includes a blood filter unit, a safety detection unit, a blood and ultrafiltration drive unit, an ultrafiltration weighting feedback regulation unit, a control unit. The utility model realizes the integrative design. A pressure sensor in the safety control unit includes an absolute pressure component and at least one pressure sensor protector. As the relatively expensive absolute pressure component can be used repeatedly, the using cost is greatly saved. In addition, the utility model also has the advantages of safe ultrafiltration process and easy operation.

Description

By the mechanicalness diuretic profit sodium device of peripheral vein to vein extracorporeal circulation realization
Technical field
This utility model relates to a kind of medical apparatus and instruments, and especially a kind of sharp sodium device of realizing by peripheral vein to vein extracorporeal circulation of mechanicalness diuretic is mainly used in retention of sodium and water diseases such as treatment chronic heart failure and refractory edema.
Background technology
Often there is the overweight situation of liquid load (preload) in patients with heart failure, and therefore, controlling retention of sodium and water safely and effectively is one of effective measures of treatment heart failure.The at present domestic hemodialysis/filtration equipment of treatment renal failure that generally uses is clinically realized dehydration, reaches the purpose of treatment heart failure, but this kind equipment is for the design of treatment renal failure, is not suitable for the treatment of chronic heart failure.Because kidney dialysis machine extracorporeal circulation pipeline caliber is thick, flow big, the extracorporeal circulation blood volume is higher, increased the weight of cardiac load, cause hemodynamic instability; In addition, this kind equipment need use displacement liquid simultaneously, can influence water power medium and acid-base balance, environment disorder in causing; The kidney dialysis needs to use the central vein intubate to set up extracorporeal circulation, could satisfy high blood flow, but the central vein intubate has a big risk.Therefore this dialysis machine can only be used for serious symptom intensive care unit (ICU, intensive care unit) or dialysate chamber environment, is not suitable for patients with heart failure.
In the prior art, U.S. Pat 6890315B1 discloses a kind of device and using method that is used for the treatment of heart failure, this patented technology reaches by ultra-filtration process gets rid of excessive liquid in the blood samples of patients, the process that realizes blood ultrafiltration is shown in Fig. 1-a: the blood of extracting out from patient's peripheral vein blood vessel is injected into the filter 5 by blood pump 2, micromolecule solute and hydrone (molecular weight is not more than 5000-6000 dalton) are come out by sucking filtration and deliver in the filter liquor collecting bag 6, and the blood of process ultrafiltration returns in patient's body.Wherein behind blood pump 2 front and back, filter 5, all be provided with pressure transducer 1,3,7, in order to monitoring extracorporeal circulation pipeline flow velocity; A bubble detection device 4 is set before filter 5, can blood pump 2 is shut down by control unit when detecting gas, no gas exists in the intravital blood of patient to guarantee to be recycled to.In addition shown in Fig. 1-b, also disclose in this patent and can adopt a ultrafiltrate pump 10, to realize meticulous control to filter liquor, and ultrafiltration pressure pick off 8, with the situation of condensing of dirt in monitoring ultrafiltration pressure and the filter, a blood leakage pick off 9 is monitored the seepage situation of erythrocyte.But there is following shortcoming in the disclosure technology:
1) pressure transducer of Cai Yonging is attached on the catheter wall, is connected as a single entity with conduit, after ultra-filtration process finishes, be dropped together with conduit, and can not reuse, not only caused the waste of resource, more can increase the use cost of each ultra-filtration process greatly, increase the burden of patient and hospital.
2) in this patent and the unexposed blood pump that adopts and ultrafiltrate pump backstop is set, the probability that exists pump to reverse in ultra-filtration process causes potential safety hazard.In addition, in order to guarantee patient's safety, before implementing ultrafiltration, must use normal saline that a whole set of pipeline is dashed in advance, and unexposed any compulsory mode in the prior art, mean that breaking through journey in advance might not carry out owing to operator's carelessness, thereby patient safety is threatened.
3) in order to keep extracorporeal circulation pipeline and filter blood smoothness, blood coagulation does not take place mainly by using anticoagulant.And do not relate to the heparin pump that anticoagulant is used in the United States Patent (USP) technology, and therefore need the other supporting use heparin pump of user oneself, very inconvenient.Therefore,, just need to prepare multiple devices, increased medical personnel's burden, because additional accessory is many, will cause treating the increase of risk simultaneously in order to implement ultra-filtration process.
The utility model content
For this reason, the technical problems to be solved in the utility model be at first to provide a kind of cost of integrated design cheap relatively pass through the sharp sodium device of mechanicalness diuretic that peripheral vein to vein extracorporeal circulation realizes; Secondly, provide a kind of sharp sodium device of mechanicalness diuretic that peripheral vein to vein extracorporeal circulation realizes that passes through safe in utilization; Once more, provide a kind of sharp sodium device of mechanicalness diuretic that peripheral vein to vein extracorporeal circulation realizes that passes through easy and simple to handle.
For solving the problems of the technologies described above, the technical solution of the utility model is:
A kind of sharp sodium device of realizing by peripheral vein-vein extracorporeal circulation of mechanicalness diuretic comprises:
The hemofilter unit comprises a hemofilter, and described hemofilter comprises three ports: a blood inlet connects the blood drawing pipeline, and a blood outlet connects the blood back pipeline, and a ultrafiltrate outlet connects the ultrafiltrate pipeline; Safety detection unit, the leakage blood examination that comprise the pressure transducer that is arranged at described blood drawing pipeline, blood back pipeline and ultrafiltrate pipeline respectively, is arranged at the ultrafiltrate pipeline are surveyed device, are arranged at the bubble detection device of blood back pipeline; Driver element comprises the blood pump that is arranged at described blood drawing pipeline; Control unit is connected with above-mentioned each unit and controls its operation; The integrated device of the sharp sodium device of described diuretic, the pressure transducer in the described safety detection unit comprises absolute pressure parts and at least one pressure transducer protector; Described pressure transducer protector is provided with a cavity, is provided with the hydrophobic membrane that one deck can stop fluid molecule only to allow gas molecule to pass through in the cavity.
Described pressure transducer protector is two; it is inner that described absolute pressure parts are arranged at described device; first protector is arranged at described device inside and is connected with described absolute pressure parts; it is outside that second protector is arranged at described device; the one end removably is connected with described first protector; the other end is connected with exterior line, and described second protector is a disposable unit.
Described pressure transducer protector is one; it is inner that described absolute pressure parts are arranged at described device, and it is outside that described protector is arranged at described device, and the one end removably is connected with described absolute pressure parts; the other end is connected with exterior line, and described protector is a disposable unit.
Described device also comprises the ultrafiltrate feedback regulation unit of weighing, and further comprises the ultrafiltrate gathering-device that is arranged at ultrafiltrate pipeline end and coupled LOAD CELLS.
Described driver element also comprises the ultrafiltrate pump that is arranged at described ultrafiltrate pipeline, after the described bubble detection device in the described blood back pipeline venous clamp is set also.
Described blood pump and described ultrafiltrate pump are provided with and prevent the inverse backward hold device of pump head.
Described device comprises that also heparin injects the unit, links to each other with described blood drawing pipeline, further comprises a heparin storage device and heparin is injected the heparin pump of described blood drawing pipeline.
Filter membrane area in the described hemofilter is greater than 0.2m 2Be less than or equal to 0.3m 2, the transmembrane pressure of described hemofilter is less than or equal to 500 millimetress of mercury greater than 250 millimetress of mercury.
It is the central processing unit of ARM7 or ARM9 or DSP that described control unit adopts model.
Described blood drawing pipeline, the blood back pipeline, and the conduit external diameter of ultrafiltrate pipeline is not more than 5 millimeters, and internal diameter is not more than 3.2 millimeters, and material is a medical PVC.
Technique scheme of the present utility model has the following advantages compared to existing technology:
1) reduces cost greatly.Adopt pressure transducer of the present utility model to reuse, reduced the cost when equipment uses at every turn; Realized integrated design between each unit.
2) ultrafiltration (ultrafiltration) process safety.By the pump that uses mechanicalness backward hold device is set all, and adopts and force pre-punch die formula and the pressure calibration pattern of weighing, improved the safety that equipment uses greatly.
3) adopt the method for injecting heparin to prevent the hemostasis-coagulation phenomenon, make operation easier; And this utility model is integrated heparin pump and the sharp sodium device of diuretic, realizes integrated design, reduces the usage quantity of instrument, simplifies therapeutic process.
Description of drawings
For the easier quilt of content of the present utility model is clearly understood, according to specific embodiment of the utility model also in conjunction with the accompanying drawings, this utility model is described in further detail below.At first accompanying drawing is carried out brief description, wherein:
Fig. 1 wherein a, b is the disclosed device sketch map that is used for the treatment of heart failure of U.S. Pat 6890315B1;
Fig. 2 is the device sketch map of an embodiment of the present utility model;
Fig. 3 is the structure chart of the pressure transducer that adopts among the embodiment of the present utility model;
Fig. 4 is the pressure-output voltage figure of pressure transducer among the embodiment of the present utility model;
Fig. 5 be adopt among the embodiment of the present utility model surmount the non-return schematic diagram of bearing;
Fig. 6 is the circuit diagram of the control unit that adopts among the embodiment of the present utility model, and wherein, Fig. 6-a is display control circuit figure; Fig. 6-b is motor pulse control circuit figure; Fig. 6-c is pressure detecting (negative pressure) circuit diagram; Fig. 6-d is keyboard control circuit figure; Fig. 6-e is for weighing and pressure detecting (positive negative pressure) control circuit figure;
Fig. 7 is the flow chart of an embodiment of the analog input of this utility model control unit and A/D convertor circuit;
Fig. 8 wherein a forces pre-dashing and the flow chart of forcing to weigh and calibrate among embodiment of this utility model; B is the flow chart of treatment pattern among embodiment of this utility model;
Fig. 9 this utility model input signal is converted to the flow chart of an embodiment of output signal through control unit.
The specific embodiment
The utility model will be further described below in conjunction with drawings and Examples, but should be noted that these embodiment only are used to equipment of the present utility model and method are described, and scope of the present utility model can not be confined to this.
Below will realize that each equipment and device are described the process of ultrafiltration and this device from the sharp sodium device of this utility model mechanicalness diuretic.
At first the sharp sodium device of this utility model diuretic is realized that the process of ultrafiltration describes in conjunction with Fig. 2.Whole ultra-filtration process be can realize by the sharp sodium device of the diuretic among Fig. 2, the process devices needed of micromolecule solute excessive in patient's body and hydrone and blood discharge, ultrafiltration and send the intravital process of patient at last back in patient's body promptly got rid of.In the present embodiment, hemofilter 300 is core components of realizing ultrafiltration, comprises three ports: a blood inlet 301 connects the blood drawing pipeline, and a ultrafiltrate outlet 302 connects the ultrafiltrate pipeline, and a blood outlet 303 connects the blood back pipeline.With hemofilter 300 is the center, and the sharp sodium device of mechanicalness diuretic is realized that the process of ultrafiltration is divided into following three steps promptly:
1) in the blood drawing pipeline, adopt common blood transfusion needle insertion patient's peripheral vein, behind the opening device, blood pump and ultrafiltrate pump entry into service, blood is discharged from patient's peripheral vein, and provides power to inject hemofilter 300 by blood pump 201; Before blood pump 201, blood pump 201 back (before the hemofilter 300) be provided with pressure transducer 101,102 respectively, to monitor loine pressure at any time.A heparin pump 400 is set before hemofilter 300, heparin is squeezed into hemofilter 300 from hemofilter 300 preceding conduits, purpose is anticoagulative generation, heparin pump 400 integrates with the sharp sodium equipment of whole diuretic, this be do not adopted in the existing treatment heart failure technology exhausted, used equipment is farthest simplified, and the easier blood coagulation phenomenon of avoiding, operate also easier.
2) blood of hemofilter 300 301 infra that enter the mouth, outlet 303 are last, and the hemofilter preferred vertical is placed; The concrete parameter of hemofilter will describe in detail below, and this does not give unnecessary details.In the ultrafiltrate pipeline, ultrafiltrate outlet 302 is arranged at hemofilter 300 bottoms near blood arrival end 301 places, connect a ultrafiltrate pump 202, in order to the finely regulating ultra-filtration process, make micromolecule solute and hydrone under the transmembrane pressure of setting (TMP) from blood ultrafiltration come out, and deliver in the ultrafiltrate gathering-device 501.Gathering-device 501 hangs on the LOAD CELLS 502, and LOAD CELLS 502 connects by circuit with control unit 600, to reach accurate monitoring and the adjusting to ultra-filtration process.Pressure transducer 103 is set before ultrafiltrate pump 202 and leaks blood examination and survey device 105, to guarantee carrying out smoothly of ultra-filtration process.
3) in the blood back pipeline, after discharging from the blood outlet 303 of hemofilter 300 through the blood after the ultrafiltration, by blood catheter and send the blood syringe needle to return to patient's peripheral vein.Conduit is provided with pressure transducer 104, and bubble detection device 106 and venous clamp 107 have guaranteed patient's safety to greatest extent.
More than specific embodiment of this utility model is realized that the process of ultrafiltration is illustrated and describes, below in conjunction with Fig. 2 each parts in the sharp sodium device of diuretic are launched detailed explanation and description.This utility model has been realized integrated design, according to the not same-action that each parts rose, can be divided into safety detection unit 100, blood and ultrafiltration driver element 200, hemofilter 300, heparin pump 400, ultrafiltrate weigh feedback regulation unit 500, control unit 600 and extracorporeal circulation pipeline (blood drawing pipeline, blood back pipeline and ultrafiltrate pipeline), wherein:
Safety detection unit 100
This unit mainly comprises pressure transducer 101,102,103,104, leaks blood examination survey device 105 and bubble detection device 106, is elaborated respectively below.
Pressure transducer 101; 102; 103; 104: please see Figure in 2 the specific embodiment; be provided with 4 pressure transducers in the sharp sodium device of diuretic; be arranged at blood pump 201 front and back in the blood drawing pipeline respectively; in the ultrafiltrate pipeline before the ultrafiltrate pump 202 and in the blood back pipeline behind the hemofilter 300; in order to real-time monitoring loine pressure; when in case pressure exceeds normal range; pick off is given control unit 600 with signal feedback immediately; thereby blood pump 201 and ultrafiltrate pump 202 are shut down; start sound and light alarm and screen display simultaneously; so that medical personnel are in time known ultrafiltration conditions, guarantee patient's safety.
In an embodiment of the present utility model; the concrete structure of pick off as shown in Figure 3; pressure transducer comprises pressure transducer protector I and absolute pressure parts II; wherein absolute pressure parts II is arranged at integration apparatus of the present utility model inside; protector I is arranged at described device outside, and the one end removably is connected with absolute pressure parts II, and the other end is connected with exterior line; it is a disposable unit, to measure the pressure in the exterior line.Wherein:
(1) pressure transducer protector I both sides comprise two ports respectively, and port one 1 is connected with exterior line, and another port 12 is connected with absolute pressure parts II.Pressure transducer protector I inside is the cavity of rugby shape, narrow space, thus improved pressure sensing degree of accuracy and sensitivity; In this cavity with port one 1 and 12 the vertical one deck hydrophobic membrane 13 that is provided with of connecting line, this hydrophobic membrane 13 is made for the macromolecular material with hydrophobic property, only allow air freely to pass through hydrophobic membrane 13, and hydrone and other macromole all can not see through, these hydrophobic membrane 13 material preferably polytetrafluoroethylenes (PTFE); The main purpose that adopts hydrophobic membrane 13 is for isolated blood contamination absolute pressure parts II and entire equipment, changes just the pressure transducer that comprises absolute pressure parts II needn't be used all at every turn, and reaching pressure transducer can reusable purpose; Simultaneously, adopt hydrophobic membrane 13 also to prevent the corrosion of steam, keep the drying of pick off, prolong the service life of pick off pick off.After treatment finished, pressure transducer protector I together was dropped with exterior line, to stop the possibility of cross infection, guaranteed the safety for the treatment of.
(2) the absolute pressure parts II in the pressure transducer comprises a confined space 19; confined space 19 has two films up and down: absolute pressure film 16 and pellosil 17; absolute pressure film 16 is connected with pressure port 14; pressure port 14 links to each other with the port one 2 of protector I; I sends the pressure in the exterior line to absolute pressure film 16 by the pressure transducer protector, and this pressure is that P1 is that the desire measuring pressure is the pressure of exterior line.And pellosil 17 is connected with pressure port 15, pressure port 15 pressure be that P2 is with reference to pressure, in one embodiment, P2 is an atmospheric pressure.Absolute pressure parts II also comprises output signal end 18, the pressure reduction of P1 and P2 is carried out signals collecting and is converted to the signal of telecommunication being sent to control unit 600, thereby realized detecting the purpose that blood pressure changes.Known by those skilled in the art because of this technology and to be known, so repeat no more.In this utility model,, therefore saved use cost greatly because the relatively costly absolute pressure parts of price can be reused.
In addition, in another embodiment of the present utility model, pressure transducer comprises two protectors: protector I and protector i (not shown), protector i has the structure identical with protector I, protector I is fixedlyed connected with absolute pressure parts II, be arranged at this utility model device inside, reusable; Protector i is arranged at this utility model device outside, and an end removably is connected with pressure protector I, and the other end is connected with exterior line, is disposable parts, after ultrafiltration finishes, together abandons with exterior line.After adopting two protectors of present embodiment; can not be subjected to external pollution by the better protection pressure transducer; this is to need periodic replacement to guarantee the degree of accuracy and the sensitivity of pressure transducer because the pressure transducer protector often stops up because of hydrophobic membrane; owing to adopted two protectors; therefore can reduce the stopping state of hydrophobic membrane among the pressure transducer protector I, change according to practical situation long period of can being separated by.In addition, pressure transducer protector i can select cheap model for use because of belonging to disposable product.
Pressure shown in Figure 4-output voltage figure has reflected the output signal of absolute pressure parts II of the present utility model and the variable relation between P1 and the P2 pressure reduction, abscissa is pressure reduction (P1-P2), unit is KPa, vertical coordinate is output voltage V o, unit is mV, and that the right side shows is the numerical range A of output voltage, when the pressure that obtains when pressure transducer exceeds full range, then produce spiking output, lose linear relationship.This curve is to be 10Vdc at system voltage Vs, measures temperature T ABe 25 ℃, obtain under the condition of P1>P2.As can be seen from the figure, desire measuring pressure P1 and linear with output voltage within the specific limits with reference to the pressure differential of 2 of pressure P, under a certain force value, the point on three curve a, b, the c is corresponding respectively pressure transducer can be exported when measuring standard value, maximum and minima.
Adopt the MPX2100 or the MPXAZ4115A of Freescale company in an embodiment of the present utility model, the pressure transducer that uses in this utility model also can be the reusable pressure transducer of other any types of directly buying on the market certainly.Compared to prior art, this utility model adopts reusable pressure transducer can reduce the use cost of the sharp sodium device of diuretic greatly.
Leak blood examination and survey device 105: be arranged on the outlet 302 of hemofilter 300 ultrafiltrates and 202 ultrafiltrate pipelines of ultrafiltrate pump, in order to whether there to be the blood situation of leaking in the monitoring ultrafiltrate, be whether monitoring of blood filter 300 exists erythrocyte and hemoglobin composition, feed back to control unit 600 immediately in case find to leak the blood situation, thereby blood pump 201 and ultrafiltrate pump 202 are shut down, start sound and light alarm and screen display simultaneously, guarantee the safety of ultra-filtration process.Be provided with that the former of device 105 surveyed in Lou blood examination because: the appearance of leaking the blood situation mainly is because the filter membrane breakage, in case take place to leak blood, will cause erythrocyte in the blood samples of patients etc. to need the loss of retained fraction, influence treatment safety.Leak blood examination survey device among the embodiment of the present utility model and select for use photoelectricity to leak blood examination survey device, this utility model also can adopt other any commercially available leakage blood examination to survey device certainly, to guarantee the realization of ultra-filtration process.
Bubble detection device 106: be arranged on the blood outlet 303 back blood back pipelines of hemofilter 300, return in the intravital blood of people whether have bubble in order to monitoring, can feed back to control unit 600 immediately in case find the existence of bubble, thereby blood pump 201 and ultrafiltrate pump 202 are shut down, start sound and light alarm and screen display simultaneously, and venous clamp 107 is closed, avoid the bubble intravasation to jeopardize patient's life.Bubble detection device 106 is selected for use ultrasonic or the photoelectricity bubble detection device among the embodiment of the present utility model, and this utility model technology also can adopt other any commercially available bubble detection device certainly, to guarantee patient's life security.
In addition, in the blood back pipeline, also be provided with venous clamp 107, it is arranged at bubble detection device 106 and blood returns between the blood back pipeline end of peripheral vein.Among the embodiment, when bubble detection device 106 detects when in the pipeline that blood is recycled to human body bubble being arranged, when blood pump 201 and ultrafiltrate pump 202 shut down, venous clamp 107 switches to closure state by open mode, folder closes the blood back pipeline, guarantee that bubble can not enter the human body passages through which vital energy circulates, to guarantee patient's safety.
Blood and ultrafiltration driver element 200
Blood pump 201 and ultrafiltrate pump 202: pump is made of motor, pump head and stop device three parts, and through 57 millimeters three-phase hybrid stepping motors, pump head is two roller spring Wriggling Pump Heads to motor for outward, and stop device adopts and surmounts bearing.Blood pump 201 and ultrafiltrate pump 202 are provided with mechanicalness backward hold device among the embodiment, adopt promptly that to surmount bearing non-return, wherein as shown in Figure 5, surmount the non-return principle of bearing for what this utility model adopted:
When internal ring 22 moves in the direction of the clock, outer shroud 21 maintains static, under internal ring 22 and the frictional force effect between the voussoir 23 that the radial pressure of spring 24 forms, making voussoir 23 make clockwise direction around the contact B of voussoir 23 and outer shroud 21 rotates, because the radial diameter H1 of somewhere arc surface is greater than the radial dimension of raceway 27 on the voussoir 23, make voussoir 23 in raceway 27 by wedging, rotate synchronously with internal ring 22 thereby drive outer shroud 21.When internal ring 22 rotates by counter clockwise direction, outer shroud 21 maintains static, under internal ring 22 and the frictional force effect between the voussoir 23 that the radial pressure of spring 24 forms, make voussoir 23 do counterclockwise to rotate around the contact B of voussoir 23 with outer shroud 21, because the radial diameter H2 of somewhere arc surface is less than the radial dimension of raceway 27 on the voussoir 23, make the voussoir 23 can be by wedging in raceway 27, so internal ring 22 freely rotates in the direction of the clock.In an embodiment of the present utility model, 21 of outer shrouds are fixed on the motor case and can not rotate, and internal ring 22 is fixed on the motor output shaft, and therefore, internal ring 22 can only rotate clockwise synchronously with motor.Cause motor to reverse in case fortuitous event occurs,, thereby bring into play non-return effect because of outer shroud 21 has been firmly secured to casing.
Certainly, this utility model also can adopt traditional backstop (as the BM25 of Baxter) to reach the purpose that prevents that pump head from reversing, but the most of flywheel-type structure that adopts of traditional backstop, have following shortcoming: noise is big when the possibility that the pump head existence reverses, operation, roller is easy to wear.Therefore all preferred setting of blood pump 201 in this utility model and ultrafiltrate pump 202 surmounts bearing, its advantage is: pump head can only clockwise unidirectional rotation in the running, guarantee that not only use is safer, and in the complete equipment running, can not produce any noise, in the bearing between each parts wearing and tearing reduce, make the corresponding prolongation in service life of pump.In addition, this utility model also can only adopt the purpose of blood pump with the realization ultrafiltration, but can't accomplish the accurate control to ultra-filtration process.
Next, relevant parameter and the effect to blood pump 201 and ultrafiltrate pump 202 describes and describes.Blood pump 201 and ultrafiltrate pump 202 are step motor drive, by rotation stepping angle≤0.6 degree that drive circuit is realized, revolution step number 〉=6000, the accuracy controlling of realization blood flow and ultrafiltration volume; The pump line of blood pump 201 and ultrafiltrate pump 202 preferably adopts health level platinum silica gel tube, its internal diameter≤3.2 millimeter, pipe thickness≤1.6 millimeter.The main effect of blood pump 201 is to provide power for whole ultra-filtration process, blood is extracted out in patient's body and injected hemofilter 300 and carry out ultrafiltration, at last the blood after the ultrafiltration is returned in patient's peripheral vein, and control volume outer circulation blood flow rate is not more than 60 milliliters of per minutes.The main effect of ultrafiltrate pump 202 is to produce negative pressure, make the blood in the hemofilter 300 obtain certain transmembrane pressure, micromolecule solute and moisture unnecessary in the blood see through filter membrane, be filtered out, be sent in the ultrafiltrate gathering-device 501, whole ultra-filtration process does not need to provide displacement liquid, therefore avoided using destruction water power medium and the acid-base balance that displacement liquid caused, harmful effects such as interior environment disorder, be not more than 12 milliliters of per minutes by ultrafiltrate pump 202 control dehydration (ultrafiltration) speed, preferable range is 100-720 milliliter per hour, and the continuous scalable of dewatering speed.
Hemofilter 300
Hemofilter 300 in this utility model is made of shell and hollow fiber bundle, the hemofilter 300 filterable molecular weight that end are greater than 50,000-60,000 dalton, membrane area is less than or equal to 0.3 square metre greater than 0.2, can tolerate transmembrane pressure (TMP) more than or equal to 500 millimetress of mercury, filtration coefficient (KUF) is every square metre of every mmhg pressure 25-40 milliliter per hour, single fiber blood passes through 0.2 millimeter of diameter, and length 18-25 centimetre, effective filter fiber quantity≤1000.Wherein, the preferred polysulfone material of fibrous material is mainly due to polysulfone material cracky not, function admirable; The blood chamber vol of hemofilter 300 is not more than 20 milliliters.Hemofilter 300 preferred vertical are placed, and blood is sent into from hemofilter 300 bottom blood inlets 301, send from top, ultrafiltrate outlet 302 near the main cause of hemofilter 300 bottoms is: micromolecule solute that filters out and hydrone are because action of gravity flows to the hemofilter bottom certainly, with blood flow to just in time opposite, help micromolecular filter process more.
Heparin injects unit 400
This unit comprises a heparin storage device 401 and heparin is injected the power set heparin pump (not shown) of blood drawing pipeline.The main purpose that adopts heparin to inject unit 400 is to prevent condensing of clot on the filter membrane, makes ultra-filtration process smooth.And in the prior art, the heparin injection device generally is used in the kidney dialysis procedure, do not see the open file that is used in the heart failure treatment is arranged, this patent not only is used for the treatment of the heparin injection device retention of sodium and water diseases such as heart failure and refractory edema, and heparin injection device and ultrafiltration apparatus integrated, realized the integrated of equipment, therefore in the process that realizes the sharp sodium of diuretic, do not need to use multiple devices, simplified the instrumentation process greatly, make things convenient for medical personnel's use, reduced the maloperation odds in the operating process.In one embodiment, before the treatment pattern, at first start the heparin pump that heparin injects unit 400, in hemofilter 300, inject a certain amount of heparin, after entering the treatment pattern, continue to inject heparin and adjust the heparin flow, wherein, after starting heparin pump, regularly detect blood coagulation and detect (as checking ACT, APTT etc.), adjust heparin pump speed according to assay.The heparin pump that this utility model adopts is common stepper motor, and flow velocity is 0.1-9.9ml/h, and heparin storage device 401 can be selected the syringe of 20ml or 50ml for use.
The ultrafiltrate feedback regulation unit 500 of weighing
This unit comprises gathering-device 501 and the LOAD CELLS 502 that is used to collect ultrafiltrate.Wherein, gathering-device 501 hangs on the LOAD CELLS 502, and LOAD CELLS 502 connects with control unit 600, to reach accurate monitoring and the adjusting to ultra-filtration process.Adopt PW6K2C3 type LOAD CELLS among the embodiment of the present utility model, also can adopt other any commercially available LOAD CELLS to reach the purpose of regulation and control and detection ultrafiltration conditions certainly.
Control unit 600
As shown in Figure 7, this unit comprises central processor CPU 601 and memorizer (not shown), reaches analog input and A/D convertor circuit 602.
Central processor CPU 601 and memorizer: the core of control unit 600 of the present utility model is a central processor CPU 601, adopts the high-performance 32-bit microprocessor as central processing unit among embodiment of this utility model, as ARM7 or ARM9, or DSP.Wherein, as shown in Figure 6, be the ARM7 circuit diagram that an embodiment of the present utility model adopts, wherein, Fig. 6-a is display control circuit figure; Fig. 6-b is motor pulse control circuit figure; Fig. 6-c is pressure detecting (negative pressure) circuit diagram; Fig. 6-d is keyboard control circuit figure; Fig. 6-e is for weighing and pressure detecting (positive negative pressure) control circuit figure.Memorizer adopts nonvolatile memory to get final product.
Analog input and A/D convertor circuit 602: among Fig. 7, in the sharp sodium device of mechanicalness diuretic LOAD CELLS 502 and be positioned at blood pump front and back, ultrafiltrate pump, hemofilter after four pressure transducer 101-104 and the analog voltage signal that obtains of LOAD CELLS 502 transfer to integrated filtering amplification A/D convertor circuit 602.Because the chip that adopts integrates instrument amplifier (IA) and analog-digital converter (ADC), makes the analogue signal amplification process become digital signal to finish simultaneously with analog signal conversion.The analog signal conversion process is in the control unit 600 of tradition dialysis apparatus: the analogue signal that single-sensor produces is transported to ADC by the operational amplifier of correspondence with analogue signal amplification back repeated transmission and is carried out the analog signal conversion process, whole analog signal conversion is to have in the process of digital signal that to influence the data precision factor many, circuit board (PCB) area is big, the amplifier gain mostly is hardware setting, for artificial the setting made troubles.And the transmission signal of a plurality of pick off 101-104 can finish on integrated chip simultaneously that analogue signal is amplified and the process of conversion of signals in this utility model, has that PCB is little, data precision is high, the advantage of gain software set.The digital signal that produces through AD conversion back transfers in the core CPU 601 of control unit 600 by spi bus, CPU passes through computing, examination, logical judgment to pressure and the weight information that obtains, the output corresponding instruction is to execution unit, realizes the Signal Processing that transmits from each pick off and will handle signal feedback that the back the produces process to relevant device in the device or parts.Wherein, SPI refers to Serial Peripheral Interface, and the SPI main feature has: can send and receive serial data simultaneously, can be used as main frame or slave work, the programmable frequency clock is provided, send the end interrupt sign, write conflict protection, bus contention protection etc.Compared to prior art, the control unit 600 precision height in this utility model, program operational efficiency height makes ultra-filtration process more safe and effective.
More than the sharp sodium device of this utility model mechanicalness diuretic is realized that each equipment and device are illustrated and describe in the process of ultrafiltration and this device, as can be seen, this utility model has been realized integrated design, safety and effectiveness all improve greatly.Next will realize that the control procedure of ultrafiltration is described to this device, below this process will be divided into the process and the multitasking process of control ultrafiltration process, describe respectively:
The process of control ultrafiltration process, this process can be divided into before the treatment pattern again and the treatment pattern under two parts, wherein:
Before the treatment pattern: for the safety that the sharp sodium device of mechanicalness diuretic uses, this utility model is provided with pre-punch die formula and the pressure calibration pattern of weighing of forcing.Shown in Fig. 8-a, in one embodiment, after the sharp sodium device energising of diuretic of the present utility model, system powers on and is in original state, at first enter the System self-test flow process, have only when self check and do not find anyly unusually just can enter the next stage flow process, (be mainly hardware fault if note abnormalities, have fault as pick off or detector circuit) then directly be back to original state, reenter the System self-test flow process through adjusting; System self-test by after enter the calibration flow process of weighing, LOAD CELLS 502 calibrations are carried out in pressure, complete successfully calibration and weighting error and be not more than for 5 whens gram, LOAD CELLS 502 transfers to control unit 600 with the signal that receives, to finish to weigh calibration process, enter the next stage flow process, to ensure that LOAD CELLS 502 is accurate, if weighting error then is back to original state greater than 5 grams, reenter the System self-test flow process through adjusting; The calibration flow process of weighing by after enter the pre-punch die formula of forcing, execute the pipeline that washes whole blood flow warp with normal saline in advance, if can not enter the next stage flow process, but be back to original state through pre-swash of wave Cheng Ze, guaranteed patient's safety; Just can enter the treatment pattern after forcing pre-swash of wave journey logical, finish until treatment.The characteristics of forcing in this utility model to dash in advance with the calibration flow process of weighing are: force to weigh calibration and pressure are carried out pipeline and are dashed in advance, wherein any one-level flow process all can not be skipped, and guarantees that LOAD CELLS 502 can accurately feed back the ultra-filtration process progress and guarantee the safety that the patient uses.
Wherein, the implementation procedure of forcing to dash in advance is: under the control of central processor CPU 601, equipment entered automatically in advance towards state after the calibration of weighing was finished, after washing the beginning open in advance, driver element will be injected into the pipeline of whole blood flow warp in advance towards liquid, the ultrafiltrate outlet of ultrafiltrate by hemofilter 300 flows to weigh gathering-device 501 in the feedback regulation unit 500 of ultrafiltrate, this gathering-device 501 hangs on the LOAD CELLS 502, when the ultrafiltrate weight in the gathering-device 501 during greater than preset value, as 400 grams, promptly mean the extracorporeal circulation pipeline of flowing through (blood drawing pipeline, the blood back pipeline, and ultrafiltrate pipeline) enough finished flushing of pipeline towards liquid in advance, LOAD CELLS 502 transfers to control unit 600 with the signal that receives, and the instruction that control unit 600 will receive exports described driver element 200 again to, and system identification is broken through journey in advance and finished, finish to break through journey in advance, enter the treatment pattern; Otherwise be back to original state.
In another embodiment of the present utility model, after the calibration of weighing was finished, equipment entered extracorporeal circulation pipeline IC-card identification step, had only after IC-card identification is correct, just can force pre-swash of wave journey, otherwise be back to original state.Known by those skilled in the art because of this technology and to be known, so repeat no more.
Under the treatment pattern: among the embodiment of the present utility model, shown in Fig. 8-b, at first enter the parameter setting up procedure after entering the treatment pattern, the parameter of input mainly comprises: pressure alarm limit value (need import 4 groups of eight numerical value as four pressure transducer 101-104), blood pump 201 and ultrafiltrate pump 202 speed, pre-ultrafiltration volume etc.Medical personnel need be according to the difference of patient's situation, and by keyboard input relevant parameter, blood pump flow is 10-50ml/min usually, and the ultrafiltrate pump flow is 0-600ml/h.After setting up, parameter begins ultra-filtration process, detect leakage blood in case leak blood examination survey device, pressure transducer before the blood pump, behind ultrafiltrate pump or the hemofilter detects loine pressure overshoot scope, power-down conditions when taking place or instability occurs weighing in the down Monitor Unit device monitoring, all can stop ultra-filtration process, blood pump, ultrafiltrate pump shut down, and open sound and flashing light alarm and screen prompt; When bubble detection device detects bubble, close venous clamp, and stop ultra-filtration process, blood pump, ultrafiltrate pump shut down, and open sound and flashing light alarm and screen prompt, after fault is got rid of, and return ultra-filtration process, continue ultrafiltration.In addition, unsettled judgement is described further to weighing, when the ultrafiltrate weightening finish surpasses certain numerical value in LOAD CELLS 502 measures sometime section (as increasing weight greater than 0.25g each second), then equipment is thought ultrafiltrate gathering-device 501 instabilities, the instability of promptly weighing.When any one parts does not all detect abnormal conditions and ultrafiltrate and reaches preset value, whether stop the judgement of ultrafiltration according to practical situation,, then be back to parameter step is set if also need to continue ultra-filtration process, reset parameter, proceed ultra-filtration process; If wish to stop ultra-filtration process, then finish treatment.
Wherein, as shown in Figure 9, when bubble detection device detects bubble, leak blood examination survey device and detect leakage blood, before and after the blood pump, before the ultrafiltrate pump and four road pressure transducers behind the hemofilter any one when detecting loine pressure overshoot scope, be that any one parts is when detecting abnormal conditions, the capital is sent to control unit 600 with the signal that obtains, the output signal of Chan Shenging is sent to the blood pump motor simultaneously after treatment, the ultrafiltration motor, audible alarm, flashing light alarm and display system, make blood pump, ultrafiltrate pump shuts down, open sound and flashing light alarm and screen prompt, when wherein in a single day bubble detection device detects bubble, also can venous clamp be closed, thereby guarantee the safety of patient under the abnormal conditions by control unit 600.This utility model also is provided with power down warning and power supply switching device shifter, down Monitor Unit continuous monitoring power devices situation, in the ultra-filtration process, adopt mains-supplied, in case the unexpected power down of equipment run duration, the down Monitor Unit device is enabled the back immediately by battery, and power-off signal is transferred to control unit 600, control unit 600 transfers to alarm with the signal that produces, and starts audible alarm, and automatically switches to the back-up source power supply, with plan safety, wherein, the backup battery of this machine can only be reported to the police for power down power is provided, and execution units such as blood pump ultrafiltrate pump is not powered.
The multitasking process: this utility model central processor CPU 601 adopts the C Programming with Pascal Language, under the support of multitask embedded OS uCOS II, realizes the sharp sodium device of diuretic is implemented the control of ultra-filtration process.In the fact Example of the present utility model, mainly there are five states in the uCOSII system, i.e. run mode, pending state, ready attitude, dormant state and interrupt status, and these five states can be changed after receiving outer signals.This utility model is given full play to the advantage of multitask embedded system uCOSII, realization is handled keyboard, pressure, the input signal of weighing, leak peripheral components such as blood, bubble, and make logical analysis and judge, central processor CPU 601 sends command adapted thereto afterwards, act on execution unit, finish default task.Because the uCOSII system is known by those skilled in the art and is known, so repeat no more.
In addition, in the extracorporeal circulation pipeline, the blood drawing pipeline, the blood back pipeline, and the external diameter of the conduit of ultrafiltrate pipeline is not more than 5 millimeters, internal diameter is not more than 3.2 millimeters, and the material of selecting for use is medical PVC or other medical macromolecular materials, and guarantees that extracorporeal circulation pipeline and the total blood volume of hemofilter are not more than 80 milliliters.Arrange blood and send the blood syringe needle to adopt medical blood transfusion syringe needle to get final product.Wherein, aforesaid peripheral vein is meant extremity and the shallow table vein of incidence, as cephalic vein, basilic vein, median vein, the external jugular vein of upper limb, shallow table veins such as the great saphenous vein of lower limb.
By above-mentioned explanation and description, the sharp sodium device of mechanicalness diuretic in this utility model is realized that the process of ultrafiltration is summarized as follows:
When beginning to carry out ultra-filtration process, medical personnel are according to patient's concrete condition, the order that will carry out by the control button on touch screen input, adjusting, parameter as pump speed are provided with etc., just can realize ultra-filtration process, wherein, as shown in Figure 9, the signal that the control button produces is converted to output signal by control unit 600 and is delivered to display system, display backlight control.In therapeutic process, bubble detection device, leakage blood examination are surveyed before device, blood pump front and back, the ultrafiltrate pump and four road pressure transducers, down Monitor Unit device behind the hemofilter are monitored ultra-filtration process in real time, to guarantee the safety of patient under the abnormal conditions.In this external whole therapeutic process, the weight of ultrafiltrate is monitored in real time, accomplished meticulous control ultra-filtration process; When the amount of ultrafiltrate reached preset value, as the 1-4 liter, ultra-filtration process finished, or controls the ultrafiltration process by medical personnel as the case may be.
Obviously, the foregoing description only is for example clearly is described, and is not the qualification to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here need not also can't give exhaustive to all embodiments.And conspicuous variation of being extended out thus or change still are among the protection domain of this utility model creation.

Claims (10)

1. one kind is passed through the sharp sodium device of mechanicalness diuretic that peripheral vein-vein extracorporeal circulation realizes, comprising:
The hemofilter unit comprises a hemofilter, and described hemofilter comprises three ports: a blood inlet connects the blood drawing pipeline, and a blood outlet connects the blood back pipeline, and a ultrafiltrate outlet connects the ultrafiltrate pipeline;
Safety detection unit, the leakage blood examination that comprise the pressure transducer that is arranged at described blood drawing pipeline, blood back pipeline and ultrafiltrate pipeline respectively, is arranged at the ultrafiltrate pipeline are surveyed device, are arranged at the bubble detection device of blood back pipeline;
Driver element comprises the blood pump that is arranged at described blood drawing pipeline;
Control unit is connected with above-mentioned each unit and controls its operation;
It is characterized in that: the integrated device of the sharp sodium device of described diuretic, the pressure transducer in the described safety detection unit comprises absolute pressure parts and at least one pressure transducer protector; Described pressure transducer protector is provided with a cavity, is provided with the hydrophobic membrane that one deck can stop fluid molecule only to allow gas molecule to pass through in the cavity.
2. device as claimed in claim 1; it is characterized in that: described pressure transducer protector is two; it is inner that described absolute pressure parts are arranged at described device; first protector is arranged at described device inside and is connected with described absolute pressure parts; it is outside that second protector is arranged at described device; the one end removably is connected with described first protector, and the other end is connected with exterior line, and described second protector is a disposable unit.
3. device as claimed in claim 1; it is characterized in that: described pressure transducer protector is one; it is inner that described absolute pressure parts are arranged at described device; it is outside that described protector is arranged at described device; the one end removably is connected with described absolute pressure parts; the other end is connected with exterior line, and described protector is a disposable unit.
4. as claim 1,2 or 3 described devices, it is characterized in that: described device also comprises the ultrafiltrate feedback regulation unit of weighing, and further comprises the ultrafiltrate gathering-device that is arranged at ultrafiltrate pipeline end and coupled LOAD CELLS.
5. device as claimed in claim 1 is characterized in that: described driver element also comprises the ultrafiltrate pump that is arranged at described ultrafiltrate pipeline, after the described bubble detection device in the described blood back pipeline venous clamp is set also.
6. as claim 1 or 5 described devices, it is characterized in that: described blood pump and described ultrafiltrate pump are provided with and prevent the inverse backward hold device of pump head.
7. as claim 1,2 or 3 described devices, it is characterized in that: described device comprises that also heparin injects the unit, links to each other with described blood drawing pipeline, further comprises a heparin storage device and heparin is injected the heparin pump of described blood drawing pipeline.
8. device as claimed in claim 1 is characterized in that: the filter membrane area in the described hemofilter is greater than 0.2m 2Be less than or equal to 0.3m 2, the transmembrane pressure of described hemofilter is less than or equal to 500 millimetress of mercury greater than 250 millimetress of mercury.
9. device as claimed in claim 1 is characterized in that: it is the central processing unit of ARM7 or ARM9 or DSP that described control unit adopts model.
10. device as claimed in claim 1 is characterized in that: described blood drawing pipeline, and the blood back pipeline, and the conduit external diameter of ultrafiltrate pipeline is not more than 5 millimeters, and internal diameter is not more than 3.2 millimeters, and material is a medical PVC.
CNU200720173862XU 2007-10-30 2007-10-30 Mechanical diuresis and natriuretic device implemented by extracorporeal circulation from periphery vein to vein Expired - Lifetime CN201085809Y (en)

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CNU200720173862XU CN201085809Y (en) 2007-10-30 2007-10-30 Mechanical diuresis and natriuretic device implemented by extracorporeal circulation from periphery vein to vein

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CNU200720173862XU CN201085809Y (en) 2007-10-30 2007-10-30 Mechanical diuresis and natriuretic device implemented by extracorporeal circulation from periphery vein to vein

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Patentee before: Feng Xinqing

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