CN101193669A - Dialysis machine - Google Patents

Abstract

A disposable cartridge (10) or use in a hemodialysis machine (1) has a blood flowpath for carrying a volume of blood to be treated in a dialyser and a dialysate flowpath, isolated from the blood flowpath, for delivering a flow of dialysate solution through the dialyser. The cartridge (10) is received in an engine section (4) of the machine (1). The engine section (4) has first and second platens (5, 6) which close when the cartridge (10) is inserted to retain the cartridge (10). Actuators (7) and sensors (8) arranged on the second platen (6) control operatin of the cartridge (10).

Description

Dialysis machine

Technical field

The present invention relates to dialysis machine, and especially but the non-disposable box body (catridge) that is used for haemodialysis control unit that exclusively relates to.

Dialysis be replace renal function remove unnecessary fluid and refuse from blood, such as a kind of treatment of potassium and carbamide.This treatment is impaired when uremic syndrome is called the degree of the threat (acute renal failure) to the human physiology at renal function, or uses during long-term nephropathy infringement renal function (chronic renal failure).

The dialysis of two kinds of main types is arranged, i.e. hemodialysis and peritoneal dialysis.

In peritoneal dialysis treatment, dialysis solution passes pipe and arrives peritoneal cavity.This fluid is stayed in the cavity a period of time absorbing refuse, and removes to handle by pipe subsequently.

Usually concerning patient, the commitment that long-term nephropathy is treated is treated by peritoneal dialysis, and transfer hemodialysis to entering later stage.

In hemodialysis, by arteries patients'blood is removed from health, handle by dialysis machine, and turn back to human body by vein blood vessel then.This machine passes blood the dialyser that comprises the pipe of being made by semipermeable membrane.In the outside of semipermeable membrane is dialysis solution.Semipermeable membrane from blood with refuse and unnecessary filtering flow to dialysis solution.Barrier film makes the fluid of refuse and controllable amounts infiltrate dialysis solution, prevents the loss of the bigger molecule that more needs simultaneously, as hemocyte and some protein and polypeptide.

Mainly realize by membranous Dialysis by diffusion (by the migration of the random motion of molecule from the area with high mercury to the low concentration region) and convection current (because the solute motion that the mass motion of solvent produces, normally because hydrostatic pressure difference) combination.

Come by the hydrostatic pressure that changes membranous dialysis fluid side, free water is moved along barometric gradient leap barrier film realize that fluid removes (perhaps being called ultrafiltration).

The urotoxy acid solution of correcting blood by the use bicarbonate buffer agent is too much.Bicarbonate buffer agent can also be corrected blood bicarbonate level.

Dialysis solution is made up of the sterile solution of mineral ion.Before being transported to dialyser these ion packet be contained in sterilized water and the blended acid buffer agent of bicarbonate matrix in.

The dialysis solution composition is vital for the dialysis treatment of success, because cross the level of membranous dialysis exchange, and the suitable health electrolyte concentration of the recovery that therefore produces and the ability of acid-base balance depend on this composition.

Correct composition is mainly realized by the dialysis solution that the preparation components and concentration is set at about human body normal value.

But the correct composition of realizing dialysis solution need be to the accurate control of small volume of fluid, and this realizes by complicated fluid path is provided at present, comprises multiplex pump and valve member on the dialysis machine.

This makes dialysis machine complicated and expensive shortcoming occur, because its complexity has also increased the risk of damaging.Because making machine stopping time minimum is very important to treat patient most effectively, therefore the maintenance that increases also is a problem.

Another problem of known haemodialysis control unit is that blood and dialysate lines need be installed on the dialysis machine before the treatment carefully setting about.This risk that pipeline is not correctly installed occurred, and this is the especially relevant risk of those patients a kind of and dialysis of being in.

Because disposable blood contacts with dialysis machine with dialysate lines, the risk of cross infection between the patient has also appearred increasing in this dialysis process.

Summary of the invention

The purpose of this invention is to provide a kind of hemodialysis system, alleviate in the problems referred to above some at least.

According to a first aspect of the invention, a kind of disposable box body that is used for haemodialysis control unit is provided, this box body comprises blood pathway and dialysate circuit, wherein blood pathway is used for delivering the blood of the recirculation volume that will handle at dialyser, and dialysate circuit and blood pathway are isolated, and the dialysis solution that is used to transmit certain flow passes dialyser.

Preferably, box body has first mixing pump and second mixing pump, and second mixing pump is accepted the homogeneous mixture of the sterilized water and the first dialysis solution matrix from first mixing pump, and introduces another dialysis solution matrix.

Preferably, dialysate circuit comprises first three-way valve of the first dialysis solution mixing pump upstream, and first three-way valve is controlled the transmission of the first dialysis solution matrix and entered first mixing pump.

Preferably, first three-way valve has mixing pump outlet port, dialysis solution storage tank ingress port and positive-displacement pump port.

Preferably, first three-way valve is used to make the first dialysis solution matrix of certain volume can enter the first dialysis solution mixing pump at each stroke of pump.

Preferably, dialysate circuit comprises second three-way valve of the second dialysis solution mixing pump upstream.

Preferably, box body comprises the dialysis solution storage tank, more preferably at first mixing pump, first storage tank in downstream and second mixing pump second storage tank in downstream and then and then.

Preferably, blood and dialysate fluid stream pass between outer surface towards second of outer surface and box body at first of box body.

Preferably, first and second of the box body body some part at least towards outer surface are coated with deformable membrane.

Preferably, valve on the box body and pump are activated by membranous distortion by dialysis machine.

Preferably, blood and dialysate fluid stream to small part is limited by upper surface and the outwards outstanding upwards upstanding wall of lower surface from box body.

Preferably, upstanding wall is sealed by deformable membrane.

Preferably, mixing pump is a membrane pump.

Preferably, blood pathway is provided with at least one blood foam trap, and more preferably, this blood foam trap or each blood foam trap are provided with liquid level (level) pick off.

Preferably, liquid level sensor is an Optical Liquid Level Sensors, or ultrasonic liquid level sensor.

Preferably, the blood foam trap is provided with the upper and lower liquid level sensor.

Preferably, the blood foam trap is provided with the hydrophilic barrier film that is used for removing or increasing to the blood foam trap from the blood foam trap air of certain volume.

Preferably, box body is provided with the symphyogenetic positive-displacement pump plunger of three-way valve and enters the dialysis solution mixing pump with the dialysis solution matrix transmission with measuring amount.

Preferably, box body is provided with the endotoxin filter, preferably nonrecoverable endotoxin filter.

Preferably, the dialysate fluid stream is provided with the ultrasonic flow pick off, passes the flow velocity in dialysis solution path with detection.

Preferably, box body limits a series of holes, and the fluid flowing path that limits on the lower surface of the fluid flowing path that limits on the upper surface of these holes with box body part and box body partly interconnects.

According to a second aspect of the invention, be provided with the dialysis machine of the dialysis box body that is suitable for admitting first aspect present invention, this machine comprises at least one pressing plate, when this pressing plate is arranged to use box body is remained on the position on the machine.

Description of drawings

Now the present invention is described in the mode of example only and with reference to the following drawings, wherein:

Fig. 1 is the axonometric chart of dialysis machine of the present invention and box body,

Fig. 2 is the axonometric chart of engine section of the machine of Fig. 1,

Fig. 3 is the axonometric chart of box body of the present invention,

Fig. 4 is the front view of the box body of Fig. 3,

Fig. 5 is the pump front view partly of the box body of Fig. 3, shows the local details of hiding,

Fig. 6 is the front view of the box body of Fig. 3, shows the dialyser that removes cover plate,

Fig. 7 is the pump rearview partly of the box body of Fig. 3,

Fig. 8 is the vertical view of the box body of Fig. 3,

Fig. 9 is the end-view of the box body of Fig. 3, and

Figure 10 is the sketch map according to dialysis solution matrix transmission system of the present invention,

Figure 11 is the partial plan layout of another embodiment of box body of the present invention, and dialyser and box body combine,

Figure 12 is the partial perspective view of another box body of Figure 11,

Figure 13 is the side view of another box body of Figure 11,

Figure 14 is the axonometric chart according to bicarbonate box body of the present invention,

Figure 15 is the axonometric chart with the bicarbonate box body of related Figure 14 that illustrates of part figure of another embodiment of box body, and

Figure 16 is the partial perspective view according to another embodiment of box body of the present invention, shows the anticoagulant storage tank.

The specific embodiment

Figure 1 illustrates dialysis machine 1, have the cover plate of opening to expose locker room 32.This machine has the engine section 4 of admitting dialysis box body 10.

Now referring to Fig. 2, illustrate in greater detail engine section 4 and comprise first and second pressing plates 5,6, their closures when box body 10 inserts machine are held in place box body during use.Electromotor 4 has the pneumatic actuator 7 that is arranged on second pressing plate and a plurality of pick off (in Fig. 2 with the label 8 unified indications) operation with control box body 10, as subsequently will be in greater detail.

In Fig. 3 and 4, dialysis box body 10 is shown has pump part 12 (the right of the dotted line I-I among Fig. 4) and dialysis part 14 (left side of the dotted line I-I among Fig. 1).Pump part 12 has the form of planar rectangular.Dialysis part 14 has dialyser cover plate 15, and its shape is arranged to hold dialyser, as inciting somebody to action in greater detail subsequently.

Temporarily referring to Fig. 8, the pump part 12 of dialysis box body 10 has upper surface 16 and lower surface 18.Upper surface 16 and lower surface 18 are covered by transparent diaphragm 20,22 respectively, and barrier film is made by the deformable plastic material.First and second barrier films 20,22 are attached to upper surface 16 and lower surface 18 by bonding or similar known method respectively.

Now referring to Fig. 4, upper surface 16 limits a series of upstanding walls of for example being represented by label 24.Upstanding wall 24 limits the flow channel systems, as inciting somebody to action in greater detail subsequently.Each passage is enclosed on the most external of upper surface 16 by first barrier film 20.Thereby upper surface limits blood or the dialysis solution that the array of fluid passage will be dialysed with delivery.

Box body 10 also limits a series of holes, for example total being represented by label 26 in Fig. 4.These holes provide the fluid passage that passes box body 10, will describe its purpose now.

Referring to Fig. 7, lower surface 18 also limits a series of upstanding walls 24, their common labyrinth type labyrinths that limits by second barrier film, 22 closed fluid channel.

Therefore with upper surface 16, the lower surface 18 and first and second barrier films 20,22 are in conjunction with the fluid flowing path that forms a series of interconnection on pump part 12 both sides.Now further describe the labyrinth type labyrinth of this fluid flow path.

First barrier film 20 is attached on the upper surface 16, and second barrier film 22 is attached on the lower surface 18 similarly, fluid is included in their corresponding passages.

Dialyser box body 10 limits two main fluid paths, at first is the fluid path that is used for blood, secondly is the fluid path that is used for dialysis solution.The formation of blood path is as follows.

Patients'blood enters dialysis box body 10 by tremulous pulse port 28.Blood passes from upper surface 16 then, arrives lower surface 18 via arterial end oral pore 30, and here blood is carried to arterial blood foam trap 34 by tremulous pulse port channel 32 from tremulous pulse port holes 30 then.Arterial blood foam trap 34 has and is used for the blood that will the enter inlet antelabium 36 towards the bottom-boot of catcher.Blood foam trap outlet 38 is arranged on the bottom of catcher, and this outlet is carried to arterial blood foam trap hole 40 from arterial blood foam trap 34 by passage 42 with blood.

The purpose of arterial blood foam trap 34 is should remove any gas foam that may be included in wherein from arterial blood supplies.The gas foam may damage the performance of dialyser, and if they introduce again by vein blood vessel and get back to human body, also produce danger to patient.Blood foam trap 34 also is provided with top liquid level sensor port 44 and bottom liquid level sensor port 46.This liquid level sensor port 44,46 be arranged to be arranged on dialysis machine on the respective optical liquid level sensor consistent.Thereby liquid level sensor can inquire optically that arterial blood foam trap 34 is to guarantee that liquid level in the blood foam trap is more than the liquid level of bottom liquid level sensor port 46 and below the liquid level of top liquid level sensor port 44.Guaranteeing that blood level remains on makes between this two liquid level that the air that remains certain volume in the blood level catcher is very important, and any gas that delivers in the blood can move in this air.

Pass after the arterial blood foam trap hole 40, blood is carried to blood pump inlet valve 48 (see figure 4)s on upper surface 16.

Referring to Fig. 4, blood pump inlet valve 48 can be operated between following closed position and open position.Valve 48 has outside annular upstanding wall 50 and inner annular upstanding wall 52.Be provided with valve opening 54 in inner annular upstanding wall 52 inside.Annular upstanding wall 50 caves in along the direction towards box body 10 inner annular upstanding wall 52 from the outside.Between inside and outside annular upstanding wall 50 and 52, be provided with scallop hole 56 as valve 48 outlets.Thereby valve 48 has the valve inlet of valve opening 54 forms and the outlet of scallop hole 56 forms.As mentioned above, lower surface 18 has its external agency that is covered by deformable membrane 22.Deformable membrane 22 annular upstanding wall 50 against the outside towards outer surface, wherein valve is in deactivated, open mode.For the state with valve 48 changes to closed condition from open mode, dialysis machine to the outer surface of second barrier film 22 apply positive pressure with drive membranous inner surface towards inner annular upstanding wall 50 towards outer surface.This has closed the inlet of valve, prevents flowing through valve thus.

Because blood pump inlet valve 48 is in open mode, blood flow through the arterial blood foam collection hole on inside makes progress upstanding wall 50 40 and through scallop hole 56 to flow out blood pump inlet valve 48.Blood flows to blood pump access road 58 downwards and flows into blood pump 60 via blood pump inlet 62 from scallop hole 56 then.

Blood pump is limited by dome shape pump chamber 64, and blood pump inlet 62 is at this intracavity opening.Be provided with pump discharge 66 in the center of pump chamber 64.The outward flange of pump chamber 64 is limited by annular upstanding wall 68, and this wall contacts with the inner surface of second barrier film 22 to the surface of outside.The blood of certain volume is inhaled into pump chamber 64 by opening blood pump inlet valve 48 as described below.

Dialysis machine produces negative pressure so that barrier film outwards is out of shape from lower surface 18 on the outer surface of second barrier film 22.When pump chamber 64 is full of, and pump is when full stroke, and blood pump inlet valve 48 cuts out by dialysis machine, produces positive pressure with close valve orifice 54 on the outer surface of second barrier film 22.By dialysis machine the outer surface of second barrier film 22 being applied positive pressure then evacuates pump chamber 64 to order about the blood that holds in the pump chamber 64 to pass pump discharge 66.Pump discharge 66 is communicated with blood pump outlet valve 70 fluids, and this valve is identical with blood pump inlet valve 48 forms.Then, the blood pump inlet valve cuts out, and blood pump 60 drives with the pump chamber 64 of finding time by dialysis machine, blood pump inlet valve 70 in open mode so that blood can flow through valve 70 and pass blood pump outlet valve opening 72.

Thereby blood pump 60 combines with blood pump inlet valve 48 and blood pump outlet valve 70.Specifically, when blood pump during at expansion stroke, blood pump inlet valve 48 is opened, so that blood can enter pump chamber, blood pump outlet valve 70 keeps cutting out preventing and refluxes by the blood of system simultaneously.Inlet valve 48 cuts out when outlet valve 70 is opened so that the compression stroke of flow pumps can drive blood and export valve opening 72 through blood pump from pump chamber 64 then.

Blood 72 flows through pressure transducer chamber 74 from the hole then.When blood flow was crossed chamber 74, fluid pressure caused that power is applied to first barrier film 20, and this causes membranous skew again.This skew by be arranged on the dialysis machine sensor to, and this skew that records is calibrated to produce the intravital blood pressure readings of box.

The blood dialyser blood port 76 of flowing through from pressure transducer chamber 74 then.

Now referring to Fig. 6, blood flows to dialyser blood lines 78 downwards and enters the bottom of the dialyser 80 of Known designs from dialyser blood port 66.Dialyser 80 comprises a plurality of axially extended semi-permeable pipe of blood process.When flowing out dialyser 80, blood advances to dialyser downwards and returns blood lines 82, returns port 84 via dialyser blood afterwards and enters venous blood foam trap 86.

Venous blood foam trap 86 is that with arterial blood foam trap 34 similar parts it has inlet antelabium 88, Optical Liquid Level Sensors 90 and hydrophilic barrier film 94 so that dialysis machine can inject the air of certain volume to keep constant blood level in the foam trap from the foam trap extraction or to foam trap in design.Venous blood liquid level catcher 86 also is provided with ultrasonic liquid level sensor 92, will further describe its design after a while.Be useful on the thrombus filter 96 that captures blood clotting in the foam trap in the bottom of valve catcher.Thrombus filter be conical form (as in the known thrombus filter) or be wedge shape.Through after the thrombus filter 96, blood will be described in more detail it after a while through hypersonic flow speed sensors 98.Blood turns back to patient via vein port 100 then.

Therefore blood is finished it from tremulous pulse port 28, through arterial blood foam trap 34, blood pump inlet valve 48 and enter the passage that passes dialysis box body 10 of blood pump 60.Blood is driven through blood pump outlet 70 and via crossing over diaphragm pressure sensor 74 from blood pump 60 and enters dialyser 80.From dialyser 80 outflows the time, blood returns port 84 via dialyser blood and turns back to dialysis box body 10.From port 84 outflows the time, blood enters venous blood foam trap 86, passes thrombus filter 96 and flows to pick off 98, and turn back to patient then via vein port 100.

Syringe 71 is set certain volume injected blood lines between blood pump outlet valve 70 and the dialyser 80 such as the anticoagulant of heparin.Syringe plunger 73 is driven by machine engine as shown in Figure 2.

As mentioned above, cross over semi-permeable membrane and dialyse, in this case, semi-permeable pipe is arranged in the dialyser 80.As mentioned above, the center of the more than half osmos tubes of blood flow, and therefore next dialysis solution flow in the space between the pipe of dialyser 80.Now will describe on the box body dialysis solution in detail with the mixing of correct concentration.

The dialysate circuit that pump part 12 limits except above-mentioned blood pathway.

Therefore, dialysis box body 10 is used for a small amount of dense bicarbonate solution and small amount of acid solution are mixed into the sterilized water supply.The dialysis solution that produces is partly extracted out so that this solution is delivered to dialyser from pump.Box body has also been considered the accurate detection of dialysate constituents concentration, dialysate flow rate and dialysate pressure.

Sterilized water enters dialysis box body 10 via sterilized water inlet 102.Sterilized water mixes with the bicarbonate solution matrix of controlled quatity then, and is as described below.Box body 10 delimit chamber 104 are used to hold the plunger (for clarity not shown in Fig. 3 to 9) of one positive-displacement pump.Three-way valve 106 synergy of this pump and Known designs.The bicarbonate solution that pump and three-way valve 106 are thrown in a controlled quatity by the dialysis machine operation with trace enters bicarbonate salt pump 108.Bicarbonate salt pump 108 is upward similar with blood pump 60 designs, and just bicarbonate salt pump 108 also is provided with the inlet 110 from three-way valve 106.Bicarbonate salt pump 108 sucks the sterilized water of a volume and enters bicarbonate inlet pump 112 with the aseptic port by label 102 places to control with flow pumps 60 strict identical modes, and bicarbonate pump discharge valve 114 keeps cutting out simultaneously.In the time of the sterilized water suction pump of certain volume, a spot of saturated bicarbonate solution injects bicarbonate salt pump 108 by positive-displacement pump.The body of positive-displacement pump is limited by the box body body.Draw saturated bicarbonate solution from the storage tank of dialysis machine.This solution is sent to pump via bicarbonate access road 105 and three-way valve 106.

Apply negative pressure and water is sucked acting in the pump chamber of pump chamber produce turbulent flow by the outer surface to first barrier film 20, this makes sterilized water and bicarbonate solution fully mix in pump chamber.Thereby in the position that bicarbonate pump intake valve 112 cuts out, outlet valve 114 is opened to displace solution from pump chamber, has realized uniform mixing completely.

Bicarbonate and aqueous solution are extracted out from pump chamber via pump discharge 116, and solution flows through the pump discharge valve 114 entry-bicarbonate solution storage tank 118 of going forward side by side from exporting 116.The volume of water-bicarbonate storage tank 118 approximately is four times of bicarbonate pump chamber volume and carries out two functions.At first it guarantees that also mixture is uniformly, and secondly as the fluid cushion agent in the dialysis solution stream, after a while its purpose will be described in further detail.

Bicarbonate storage tank 118 is provided with electric conductance detector probe 120 and temperature detecting probe 122, top liquid level sensor 124 and bottom liquid level sensor 126.

Electric conductance and temperature sensor probe be arranged to dialysis machine in conductivity sensor contact with temperature sensor.This measurement is used to infer the concentration of water-bicarbonate solution in the storage tank 118.This storage tank also is used as buffer to allow various systems pumps out-phase.Thereby the liquid level in the storage tank can raise and descend, thus the pressure peak in the flare system.

Solution sucks sour pump 128 from water-bicarbonate storage tank 118 through opening acid pump intake valve 130.Be connected with sour pump discharge valve 132 on the acid pump 128.The purpose of acid pump 128 is that small amount of acid solution matrix is introduced water-bicarbonate solution.Use with bicarbonate salt pump 108 employed same valve and pumping method and realize this process.Specifically, the plunger that second Room 107 holds second positive-displacement pump is set.The acid solution matrix of certain volume is assigned to 109 to second three-way valve 111 of sour access road downwards thus.Under the effect of pump 128, water-bicarbonate solution sucks pump chamber.The acid solution matrix is by in the second positive-displacement pump injection pump.These fluids thoroughly are blended in the turbulent flow in the pump chamber, distribute through outlet valve 132 then to enter water-bicarbonate-acid storage tank 138.

Water-bicarbonate-acid storage tank 138 is provided with electric conductance detector probe 144 and temperature detecting probe 146, top liquid level sensor 140 and bottom liquid level sensor 142, identical with water-bicarbonate storage tank 118.

Solution flows through storage tank from water-bicarbonate-acid storage tank 138 and exports 147 (see figure 7)s and enter mobile equilibrium access road 148.This solution is transferred to mobile equilibrium device 150 thus.

The purpose of mobile equilibrium device 150 is that to guarantee to suck the volume of dialysis solution of dialyser identical with the volume of extracting out from dialyser 80.Making and flowing into and flow out the purpose that the flow of dialyser is complementary is the osmotic potential that makes the osmotic potential coupling blood of dialysis solution in the dialyser.This has guaranteed to control the fluidic volume that removes or transfer to blood from blood carefully.This is vital for guaranteeing that patient can not contain water excess or be dewatered to degree of danger during dialysis treatment.

Mobile equilibrium device 150 is provided with the first-class dynamic balancing pump 152 and the second mobile equilibrium pump 154.The first and second mobile equilibrium pumps 152,154 have the operation with blood pump 60 and mixing pump 108,128 icotypes.But, because mobile equilibrium device 150 realizes that controlled fluid flows into and from dialyser 80 effusive modes, the stream that fluid is delivered to each mobile equilibrium pump 152,154 is quite complicated.

In principle, the operation of mobile equilibrium device 150 is by using first-class dynamic balancing pump 152 with dialysis solution suction dialyser, and the second mobile equilibrium pump 154 is extracted out dialysis solution after a while from dialyser, switch the second mobile equilibrium pump 154 then with dialysis solution suction dialyser, and first-class dynamic balancing pump 152 is extracted dialysis solution out from dialyser.The purpose of this operational mode is to eliminate the do not match influence of the foozle that produces of pump chamber volumes in each mobile equilibrium pump 152,154.For example, if first-class dynamic balancing pump 152 is used for for good and all with dialysis solution suction dialyser, and the second mobile equilibrium pump 154 is used for dialysis solution is extracted out from dialyser, then after a while, even little difference all can cause the suction dialyser or the danger of the volume of the dialysis solution extracted out from dialyser unbalance between the pump chamber volume of pump.

By switching the first and second mobile equilibrium pumps 152,154, any error of chamber volume can be evened up along with the time, guaranteed to cross the mobile balance of dialyser thus.

What be communicated with first-class dynamic balancing pump 152 selectivity fluids is first-class dynamic balancing pump first inlet valve 156, first-class dynamic balancing pump second inlet valve 158, first-class dynamic balancing pump first outlet valve 160 and first-class dynamic balancing pump second outlet valve 162.What be communicated with the second mobile equilibrium pump, 154 selectivity fluids similarly, is the second mobile equilibrium pump, first inlet valve 164, the second mobile equilibrium pump, second inlet valve 166, the second mobile equilibrium pump, first outlet valve 168 and the second mobile equilibrium pump, second outlet valve 170.

Now will describe first operator scheme of mobile equilibrium device 150 in detail.In first operator scheme, first-class dynamic balancing pump first inlet valve 156, first-class dynamic balancing pump second outlet valve 162, the second mobile equilibrium pump, second inlet valve 166 and the second mobile equilibrium pump, first outlet valve 168 all apply positive pressure in the zone of each valve to the outer surface of first barrier film 20 by dialysis machine and remain on detent position.Thereby in first operator scheme, the operation of the second mobile equilibrium pump 154 is sucking dialyser with dialysis solution, and 152 operations of first-class dynamic balancing pump are to extract dialysis solution out from dialyser.

Because first-class dynamic balancing pump first inlet valve 156 is in the closed position, the dialysis solution that flows out bicarbonate acid storage tank 138 is along mobile equilibrium access road 148 first-class dynamic balancing pump first inlet valve 156 of flowing through.Then dialysis solution from lower surface 18 via hole 172 to upper surface 16.Because the second mobile equilibrium pump, first inlet valve 164 is at its open position, the second mobile equilibrium pump 154 can suck pump chamber the producing negative pressure on the outer surface of first barrier film 20 with the dialysis solution of certain volume under the effect of dialysis machine.

When the second mobile equilibrium pump 154 reaches full capacity, the second mobile equilibrium pump, first inlet valve 164 just cuts out, and the second mobile equilibrium pump, second outlet valve 170 is just opened.Actuated pump 154 is discharged dialysis solution is passed through hole 174 then, and dialysis solution flows along passage 176 then, as shown in figure 10.Dialysis solution passes endotoxin filter 178 then, passes dialysis output port 180 via passage 182 then.

Now referring to Fig. 6, dialysis solution passes along dialysis inlet duct 180 from the dialysis solution port of export 180, passes from the top to the bottom along dialyser 80 then, as shown in Figure 9.For dialysis solution is turned back to pump part 12 from dialyser 80, dialysis outlet conduit 184 is carried to dialysis arrival end 186 with dialysis solution.When turning back to pump part 12, dialysis solution passes coloured Sensor section 188, so that the coloured pick off that is arranged on the dialysis machine can inquire that dialysis solution arrives blood to detect dialyser 80 internal leakages in dialysis solution.When coloured Sensor section 188 flows out, dialysis solution passes hole 190 and enters mobile equilibrium backward channel 192 therefrom.

Because the second mobile equilibrium pump, second inlet valve 166 cuts out, dialysis solution flows through hole 194 towards first-class dynamic balancing pump second inlet valve 158.Because valve 158 is at open position, first-class dynamic balancing pump 152 can suck pump chamber by inlet valve 158 with the dialysate constituents of certain volume at first barrier film 20 by dialysis machine under the effect of the malleation that produces on the outer surface.First-class then dynamic balancing pump second inlet valve 158 cuts out, and first-class dynamic balancing pump first outlet valve 160 is opened, and pump 152 drives dialysis solution from fluid chamber's process outlet valve 160.Outlet valve 160 cuts out then, and inlet valve 158 is opened, and driving pump 152 is prepared to be assigned to next pump cycle to suck the dialysis solution of another volume.

Because the second mobile equilibrium pump, first outlet valve 168 cuts out during this operator scheme, after the transmission process outlet valve 160, dialysis fluid flow via hole 196.Dialysis solution passes ultrasonic flow pick off 198 (will describe in more detail after a while) then, flows out dialysis box body 10 by dialysis solution discharger 200 then.

In second operator scheme, the task of the first and second mobile equilibrium pumps 152,154 is opposite.In other words, first-class dynamic balancing pump second inlet valve 158 and first-class dynamic balancing pump first outlet valve 160 keep closing, and operate first inlet valve 156 and second outlet valve 162 flowing with inflow of control dialysis solution and outflow pump chamber simultaneously.Similarly, about the second mobile equilibrium pump 154, the second mobile equilibrium pump, first inlet valve 164 and the second mobile equilibrium pump discharge valve 170 are maintained in its closed position, and operate the second mobile equilibrium pump, second inlet valve 166 and the second mobile equilibrium pump, first outlet valve 168 flowing with inflow of control acid solution and outflow pump chamber simultaneously.

As mentioned above, the volume that the dialysis solution of mobile equilibrium technology to guarantee suction dialyser 80 be provided with equate from the volume that wherein removes is strict.But, in some dialysis treatment, need remove unnecessary fluid from blood, perhaps need fluid is retracted blood.This realizes that by hyperfiltration treatment wherein the mobile equilibrium loop is arranged to uneven a little by introducing dialysis solution or removing small amount of liquid from dialysis solution.In dialysis cassette of the present invention, this realizes by the ultrafiltration three-way valve 206 that combines work with the positive-displacement pump held in the chamber 208 on the box body.This three-way valve and the combination of positive-displacement pump are with bicarbonate solution to be introduced bicarbonate salt pump 108 employed identical.The positive-displacement pump plunger is contained in the chamber 208 and by the driver such as stepping motor on the dialysis machine and locatees.

Box body 10 has and is used for unnecessary fluid from drain passage 202 that water-bicarbonate storage tank 118 and water-bicarbonate-acid storage tank 138 is discharged.Drain passage is from storage tank 118, the 138 unnecessary fluids of delivery and dump this fluid to discharge via the drainage port 204 that is communicated with drainage port fluid on the dialysis machine.

Thereby dialysis box body 10 provides two kinds of different streams, and first kind is used for blood, and second kind is used for dialysis solution.Upper surface 16 and lower surface 18 are provided, and the porose therebetween fluid that makes can move on the outer surface of lower surface from the surface towards outer of upper surface.Blood pathway and dialysate circuit keep separated from one another by the upstanding wall from upper surface and lower surface extension.The outer surface of upstanding wall adjoins deformable membrane so that stream is sealed.

Should be appreciated that the hole that is arranged on the first and second box body bodies 16,18 can be packed on most convenient ground various box body structures.Very clear, this feature provides the remarkable advantage that is better than all flow channels only are limited to the box body of box body one side.

In another embodiment of box body, arterial blood foam trap 34 and venous blood foam trap 86 have the Foldable structural member of accordion portion-form of plastic material with the area of limit blood/air interface.Especially advantageously blood/the air interface that reduces reduces the grumeleuse and/or the isolating risk of blood.

Another alternative characteristics of foam trap is to replace hydrophilic barrier film 94 with the membrane pump that is similar to blood pump 60.Thereby, replacing crossing hydrophilic membranous moving and air added foam trap or from wherein removing air by air, moving of air can be by applying malleation or negative pressure on the outer surface and moving regulator is realized membranous.In addition, can monitor the position that membrane activated degree adds storage tank or removes from storage tank with the air of surveying volume.

In another alternate embodiment, each valve for example 48,106,112,114,164 etc. is provided with rigid disk, and the diameter of this rigid disk is equal to or slightly greater than the inner upwards diameter of upstanding wall.Rigid disk is arranged between inner upwards upstanding wall and the barrier film.The purpose of rigid disk is to make on the barrier film needed distortion minimum with valve seal.In other words, barrier film acts on the rigid disk, and rigid disk forms the valve seat on the inner upwards upstanding wall again.The membranous result who reduces to be out of shape is owing to switch in the transient vibration ripple that produces in the valve reduce between opening and closing, because valve can cut out being lower than under the surge pressure that if there is no rigid disk is just necessary originally.Another advantage on reducing valve body the observed pressure peak is to have realized the reduction that blood damages by the operation more smoothly between the opening and closing state of valve.

Now, positive-displacement pump of the present invention and three-way valve have been schematically shown in more detail referring to Figure 10.What three-way valve was total is represented by label 106.It is identical to should be appreciated that three-way valve 106 and fluid are communicated to the valve of pump 128 and ultrafiltration valve 206.Therefore the detailed description of three-way valve 106 two other three-way valve of being equally applicable to dialyse and being provided with on the box body.

Bicarbonate mixing pump 108 is connected to the output 250 of three-way valve 106 via fluid line.Three-way valve also has storage tank inlet 252 and pump intake 254.Storage tank inlet 252 is connected to bicarbonate solution storage tank 255.Storage tank 255 is arranged on the dialysis machine, or is attached to it, and does not form the part of box body itself.What positive-displacement pump was total represents with label 258.Positive-displacement pump comprises pneumatic cylinder 260, and this pneumatic cylinder is with reciprocating mode driven plunger arm 262.At a piston arm end opposite plunger 264 (see figure 10)s that act in the box body chamber 104 are arranged with bucket cylinder.

On the backward stroke that label A represents in Figure 10, plunger 264 moves with in the dialysis solution suction chamber of bicarbonate solution storage tank 255 with measured amount in chamber 104.Close by three-way valve output 250, storage tank inlet and pump intake 252,254 stay open has realized fluidic moving.Piston arm 262 is withdrawn from up to the abutment 268 that is arranged on the piston arm 262 along the A direction and is contacted with removable end block piece 270.

When the block piece 270 of the removable end of abutment 268 bumps, drive pneumatic cylinder 268 so that dialysis solution is assigned in the bicarbonate mixing pump 108 from chamber 104 along the B direction.Fluidicly move through that storage tank inlet 252 is closed, three-way valve output 250 is opened and realized.Pneumatic cylinder 268 adjoins the left hand end of chamber 104 up to piston ring along B direction driven plunger ring 264.Thereby, move back and forth in a known way by making steam-cylinder piston arm 262, a certain amount of bicarbonate solution repeatedly is assigned to bicarbonate mixing pump 108.In addition, by regulating the position of removable end block piece 270, can accurately set the volume of institute's distributing fluids.Removable end block piece 270 is located by stepping motor or similarly accurate location drive system.

The advantage of this system is that pneumatic cylinder 260 provides desired reciprocating motion speed that the fluid of fractional dose is sent in the mixing pump 108 with desired speed.Therefore extremely accurately but can not provide the reciprocating stepping motor of desired speed only to be used for setting fluidic sendout by removable end block piece accurately is set.

Should be appreciated that bicarbonate mixing pump 108, three-way valve 106 and chamber 104 are arranged on the box body.But the remaining part of describing about Figure 10 is arranged on the dialysis machine.Therefore importantly, pneumatic cylinder, stepping motor and removable end block piece are arranged on the machine rather than on the box body.

Should be appreciated that box body of the present invention provides the mixed uniformly remarkable advantage that transmits dialysis solution at each stroke of the first and second mobile equilibrium pumps 152,154.This feature is vital for stable dialysis treatment is provided.In addition, realize needed all fluid flowing paths of uniform mixing, pump and valve all be arranged on box body originally on one's body.Because box body comprises all streams, so significant advantage is provided.

Can expect not needing to be provided with barrier film within the scope of the invention and be included in the channel interior position, can expect within the scope of the invention towards outer surface after, can removing so a part of barrier film from the box body 10 of dialysing what diaphragm was applied to box body with flowing.

In addition, consider some part that to strengthen flow channel by for example thickening upstanding wall upwards within the scope of the invention, with any deflection in the flow channel that reduces to produce by the hydrostatic pressure that changes in the fluid.

Figure 11 shows the alternate embodiment of the dialysis part 312 shown in Fig. 3 to 9.This dialysis part has the dialyser 314 that inserts first groove 316 and second groove 318, as shown in figure 12.Dialyser 314 at first inserts first groove 316, towards the dialysis partial rotation, then inserts second groove 318 then.Then dialyser 314 along the D direction move (as shown in figure 13) on the throne so that dialyser is locked.This locking on the throne also with dialyser 314 and 320,320 sealings of opposing header to provide along the blood channel of blood channel 324,326 with along the dialysis passage of passage 328,330.

Above embodiment has described bicarbonate solution and has been transferred to wherein box body from dialysis machine.In an alternate embodiment, box body is provided with bicarbonate box body 400, as shown in figure 14.Box body holds a certain amount of bicarbonate, passes this bicarbonate from the sterilized water of the sterilized water supply that is transferred to box body.Water feeds bicarbonate box body 400 via inlet 402, passes bicarbonate so that the bicarbonate in the water is saturated.Therefore bicarbonate solution flows out box body 400 through outlet 404.

In Figure 15, dialysis box body 10 ' part that bicarbonate box body 400 has modification is shown.This box body 10 ' be modified as hold plug part 406,408 with fixing dialysis box body 10 ' and the bicarbonate box body between fluid connect.For bicarbonate box body 400 being inserted into dialysis box body 10 " on, plug part 406,408 is patchhole 410,412 respectively, and the bicarbonate box body is directed downwards along E and moves with the plug spare in the mating holes 414,416 406,408 then.

In Figure 16, substituting heparin storage tank 500 is shown, as the alternative form of syringe 71.Storage tank 500 forms the dialysis box body of revising 10 " a part.This storage tank has the outlet 502 that the anticoagulation medicament is sent to blood lines by positive-displacement pump (for not shown for the purpose of clear).This storage tank has deformable satchel 504 that comprises the anticoagulation medicament and the spring part 506 that keeps malleation in the satchel 506.

Claims (30)

1. disposable box body that is used for haemodialysis control unit, described box body comprises blood pathway and dialysate circuit, described blood pathway is used for delivering a certain amount of blood that will handle at dialyser, described dialysate circuit and described blood pathway are isolated, and are used to transmit dialysis solution and flow and pass described dialyser.

2. disposable box body as claimed in claim 1 is characterized in that, described dialysate circuit forms the part of recirculation dialysis fluid circuit during use, and described loop comprises dialyser and regeneration filter.

3. disposable box body as claimed in claim 1, it is characterized in that, described dialysate circuit forms the part of continuous dialysate lines during use, and described pipeline comprises the discarded fluid issuing in sterilized water supply inlet, dialyser and described dialyser downstream from described dialysis machine.

4. as claim 1,2 or 3 described disposable box bodys, it is characterized in that described box body comprises dialyser or is suitable for being attachable to dialyser.

5. each described disposable box body in the claim as described above is characterized in that described box body is sealed described blood pathway and described dialysate circuit fully.

6. each described disposable box body in the claim as described above is characterized in that described box body comprises rigid body.

7. disposable box body as claimed in claim 6 is characterized in that, described rigid body have first towards outer surface and second towards outer surface, each is sealed by deformable membrane towards outer surface.

8. disposable box body as claimed in claim 7, it is characterized in that, described first and second towards outer surface common qualification blood flow path and the mobile passage of dialysis solution, and described deformable membrane is sealed described flow channel to form described blood pathway and dialysate circuit.

9. as claim 7 or 8 described disposable box bodys, it is characterized in that at least a portion of described blood pathway is formed on each described first and second on outer surface.

10. as claim 7,8 and 9 described disposable box bodys, it is characterized in that at least a portion of described dialysate circuit is formed on described first and second in the outer surface each.

11. as each described disposable box body in the claim 6 to 10, it is characterized in that, during use by with described first and second at least one displacable platen that cooperates towards one of outer surface and described rigid body is remained on the appropriate location in the described dialysis machine.

12. each described disposable box body in the claim is characterized in that as described above, described dialysate circuit comprises the sterilized water inlet so that sterilized water can flow on the described box body from described dialysis machine.

13. disposable box body as claimed in claim 12, it is characterized in that, described dialysate circuit comprises first mixing pump and distributor, wherein said first mixing pump has the pump chamber that is used to hold the scheduled volume sterilized water, and described distributor is used for the first dialysis solution matrix of scheduled volume is assigned to pump chamber, and described first mixing pump can be operated with the sterilized water that will produce and the homogeneous mixture of the first dialysis solution matrix and extract described pump chamber out.

14. disposable box body as claimed in claim 13, it is characterized in that, described dialysate circuit comprises second mixing pump in the described first mixing pump downstream, described second mixing pump has the pump chamber that is used to hold from the mixture of the sterilized water of the scheduled volume of described first mixing pump and the first dialysis solution matrix, described dialysate circuit also comprises the distributor that is used for the second dialysis solution matrix of scheduled volume is assigned to described pump chamber, and described second mixing pump can be operated with the sterilized water that will produce and the dialysis solution of the first and second dialysis solution matrixes and extract described pump chamber out.

15. disposable box body as claimed in claim 13 is characterized in that, the described first dialysis solution matrix is a bicarbonate solution.

16. disposable box body as claimed in claim 14 is characterized in that, the described second dialysis solution matrix is acidity or acetate solution.

17., it is characterized in that the operation of each in described first and/or second mixing pump realizes by the displacement of pneumatically actuated described deformable membrane as each described disposable box body in the claim 13 to 16.

18. as each described disposable box body in the claim 13 to 17, it is characterized in that, the operation of described first mixing pump makes the first dialysis solution matrix of described scheduled volume be transferred to described pump chamber, activate described pump simultaneously so that a certain amount of sterilized water is sucked described pump chamber, make each stroke of described pump transmit the homogeneous mixture of the sterilized water and the first dialysis solution matrix.

19. each described disposable box body as claim 14 or in the claim 15 to 18 when being subordinated to claim 14, it is characterized in that, the operation of described second mixing pump makes the described second dialysis solution matrix of described scheduled volume be transferred to described pump chamber, activate described pump simultaneously the homogeneous mixture of a certain amount of sterilized water and the first dialysis solution matrix is sucked described pump chamber, make each stroke of described second mixing pump transmit uniform dialysis solution.

20. each described disposable box body in the claim is characterized in that described box body comprises the mobile equilibrium device as described above, described device is used for realizing the balance of therapeutic process at the observed dialysate flow of described dialyser entrance and exit.

21. disposable box body as claimed in claim 20, it is characterized in that, described mobile equilibrium device comprises the first-class dynamic balancing pump and the second mobile equilibrium pump, described pump can move between two operational modes: first operational mode and second operational mode, be arranged on the downstream and the described dialyser upstream of first and second mixing pumps described in the described dialysate lines at first-class dynamic balancing pump described in described first operational mode, and the described second mobile equilibrium pump is arranged on the downstream of dialyser described in the described dialysate lines; In described second operational mode, the described second mobile equilibrium pump is arranged on the downstream of first and second mixing pumps described in the described dialysate lines and the upstream of described dialyser, and described first-class dynamic balancing pump is arranged on the downstream of dialyser described in the described dialysate lines.

22. each described disposable box body in the claim is characterized in that described box body comprises the device that is used for heparin is transferred to described blood pathway as described above.

23. each described disposable box body in the claim is characterized in that described box body comprises the device that is used to admit the bicarbonate box body as described above.

24. a dialysis machine is suitable for admitting as described above each described dialysis box body in the claim, described machine comprises at least one pressing plate, when described at least one pressing plate is arranged to use described box body is remained on the appropriate location in the described machine.

25. dialysis machine as claimed in claim 24 is characterized in that, described at least one pressing plate comprises the liquid level sensor of being arranged to detect fluid level on the described box body.

26., it is characterized in that described at least one pressing plate comprises the pressure transducer of being arranged to detect fluid pressure on the described box body as claim 24 or 25 described dialysis machines.

27., it is characterized in that described at least one pressing plate comprises is arranged to detect fluidic flow sensor on the described box body as claim 24,25 or 26 described dialysis machines.

28., it is characterized in that described at least one pressing plate comprises the color sensor of being arranged to detect blood leakage on the described box body as each described dialysis machine in the claim 24 to 27.

29., it is characterized in that described at least one pressing plate comprises the conductivity sensor of the concentration of being arranged to measure described dialysis solution as each described dialysis machine in the claim 24 to 28.

30. as each described dialysis machine in the claim 24 to 29, it is characterized in that described machine comprises a pair of pressing plate, described a pair of pressing plate lumps together in use so that described box body is held in place.

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