CN106039445A - Super-miniature dialyzer for clinical animal research and method for manufacturing super-miniature dialyzer - Google Patents
Super-miniature dialyzer for clinical animal research and method for manufacturing super-miniature dialyzer Download PDFInfo
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- CN106039445A CN106039445A CN201610676398.XA CN201610676398A CN106039445A CN 106039445 A CN106039445 A CN 106039445A CN 201610676398 A CN201610676398 A CN 201610676398A CN 106039445 A CN106039445 A CN 106039445A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1621—Constructional aspects thereof
- A61M1/1623—Disposition or location of membranes relative to fluids
- A61M1/1627—Dialyser of the inside perfusion type, i.e. blood flow inside hollow membrane fibres or tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
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- Animal Behavior & Ethology (AREA)
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Abstract
The invention relates to a super-miniature dialyzer for clinical animal research. The super-miniature dialyzer comprises a tubular shell. An inlet-end blood cap and an outlet-end blood cap cover two ends of the tubular shell, a blood inlet tube is arranged on the inlet-end blood cap, a blood outlet tube is arranged on the outlet-end blood cap, a dialysis liquid outlet tube and a dialysis liquid inlet tube are arranged on the outer side walls of the two ends of the tubular shell, a hollow fibrous membrane bundle is arranged inside the tubular shell, and space yarns are arranged among membrane bundles of hollow fibrous membranes at intervals. The invention further discloses a method for manufacturing the super-miniature dialyzer. The method includes steps of inserting membranes; sintering one end of the hollow fibrous membrane bundle; covering the end of the hollow fibrous membrane bundle with technological caps; injecting glue into the end of the hollow fibrous membrane bundle; curing the glue; shearing the end of the hollow fibrous membrane bundle; covering the tubular shell with the blood caps; sintering the other end of the hollow fibrous membrane bundle; covering the other end of the hollow fibrous membrane bundle with technological caps; injecting glue into the other end of the hollow fibrous membrane bundle; curing the glue; shearing the other end of the hollow fibrous membrane bundle; covering the tubular shell with technological caps; smearing seal glue and the like. The super-miniature dialyzer and the method have the advantages that the blood purification efficiency can be effectively improved by the aid of the super-miniature dialyzer and the method; the space yarns are arranged among the membrane bundles, accordingly, dialysis liquid can be in sufficient contact with the dialysis membranes, and the blood purification efficiency can be improved.
Description
Technical field
The present invention relates to a kind of dialyser and manufacture method thereof, particularly to a kind of superminiature for clinical zooscopy
Dialyser and manufacture method thereof, belong to dialyser field.
Background technology
Clinical common critical syndrome has acute injury of kidney, liver failure, heart failure, acute lung injury etc..Cause
They are many with hemodynamic instability, organ hypoperfusion, systemic inflammatory response syndrome, and even sepsis, septic is stopped
Gram common pathophysiological change such as grade, the most easily develops into multiple organ dysfunction syndrome (multiple organ
dysfunction syndrome,MODS).MODS is clinical common critical illness, and the state of an illness is dangerous, poor prognosis, its sickness rate and
Mortality rate is the highest, and the treatment of this type of disease spends big, poor prognosis, is the difficult problem of puzzlement various countries serious symptom medical expert.
Blood purification technology is the principle utilizing semipermeable membrane, by disperse and (or) convection current, carries out solute exchange and moisture
The blood purification treatment method removed, moisture, maintenance Water-Electrolyte and acid-base balance unnecessary in there is purged body, keep internal ring
Border is stable, can remove the features such as inside and outside source property noxious substance and some inflammatory mediator simultaneously.Blood purification is treatment critical illness
Important means, it mainly includes hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion and plasmapheresis etc..It is not
It is only a kind of kidney substitute technology, patient with severe symptoms more plays the effect of Multi-organ systems life support, it has also become critical illness is anxious
Rescue the important component part of medical science.
But the Mechanisms and therapy principle of relevant blood purification technology treatment critical illness is not readily apparent from, at present also
The key issue having many dialysis needs to be studied further, such as blood purification opportunity, blood purification pattern difference, rationally
Therapeutic dose, rational therapic opportunity, the loss of nutrient substance, impact on body's immunity.Owing to being set by experiment
Standby and the restriction of material, what current domestic and international application was most is large-scale experiment animal (such as pig, Canis familiaris L., sheep, cattle etc.) or medium-sized dynamic
Thing (such as rabbit).These zoopery cost height, operating difficulties, animal reproduction cycle length, raising difficulty, shortage species specificity
The factors such as detection kit, greatly limit development and the improvement of blood purification technology.And the meiofauna with rat as representative
Blood purification then has relative inexpensiveness, can carry out on a large scale, can repeatedly sample of tissue, be appropriate to blood purification treatment machine
The advantages such as system is studied, detection kit critical illness model complete, multiple is more ripe.But, in meiofauna body, total blood volume is relatively
Few, in blood purification clinical trial, the most dialyzable blood flow volume is less, also requires that higher to the efficiency of hemodialysis, it is adaptable to
The hemodialyzer of large-scale experiment animal can not meet requirement.
Summary of the invention
The present invention discloses new scheme for superminiature dialyser and the manufacture method thereof of clinical zooscopy, it is provided that
A kind of dialyser that can be effectively improved blood depuration efficiency and manufacture method thereof, solve existing dialyser may not apply to right
The problem of the meiofauna that hemodialysis efficiency requirements is higher.
The present invention includes tubular shell for the superminiature dialyser of clinical zooscopy, and one end capping of tubular shell has
Entrance point blood cap, the other end capping of tubular shell has port of export blood cap, entrance point blood cap to be provided with blood inlet pipe,
Port of export blood cap is provided with blood outlet tube, and the lateral wall of tubular shell one end is provided with dialysis solution outlet, tubular shell
The lateral wall of the other end is provided with dialysis solution inlet tube, and the inside of tubular shell is provided with hollow-fibre membrane boundling, hollow-fibre membrane
Boundling includes a branch of hollow-fibre membrane, and one end of above-mentioned a branch of hollow-fibre membrane is located at tubular shell by fluid sealant tissue A envelope
On the inner side of one end, the other end of above-mentioned a branch of hollow-fibre membrane is located at the tubular shell other end by fluid sealant tissue B envelope
On inner side, fluid sealant tissue A, fluid sealant tissue B, the inwall of tubular shell form the dialysis space closed, dialysis solution outlet
Connecting with dialysis space sealing, dialysis solution inlet tube connects with dialysis space sealing, dialysis solution inlet tube, dialysis space, dialysis
Liquid outlet forms the dialysis solution runner closed, and fluid sealant tissue A and entrance point blood cap form the blood inlet chamber closed, close
Sealing tissue B and port of export blood cap form the blood outlet plenum closed, and blood inlet pipe seals with blood inlet chamber and connects, blood
Liquid outlet and blood outlet plenum seal and connect, blood inlet pipe, blood inlet chamber, the membrane tube passage of hollow-fibre membrane boundling,
Blood outlet plenum, blood outlet tube formed close blood flow passage, the perineurium of above-mentioned a branch of hollow-fibre membrane be interval with sky
Between yarn, the blood in membrane tube passage is dialysed through space yarn by dialysis solution.
The invention also discloses the manufacture method of the above-mentioned superminiature dialyser for clinical zooscopy, including step:
(1) a branch of hollow-fibre membrane boundling being mingled with space yarn with setting quantity is located in and there is the tubular shell being sized
In so that the length that tubular shell two ends are identical is stretched out at hollow-fibre membrane boundling two ends；(2) will stretch out in tubulose shell one end
Hollow fiber film boundling is pruned smooth, uses flame gun will prune smooth hollow-fibre membrane boundling one end sintering, at doughnut
One end upper cover after film boundling sintering sets Technological cover A；Use syringe by AB glue injection technology lid A until AB glue from technique
The gap that lid A is combined with tubular shell is overflowed and stops injection, centrifugal solidification after the gas in AB glue in discharge Technological cover A；⑷
Use cutter machine Technological cover A of prominent tubular shell one end to be excised, check the flatness of tangent plane, surface quality, processing
The tangent plane upper cover become sets blood cap；(5) the hollow-fibre membrane boundling stretching out the tubular shell other end is pruned smooth, use flame
Rifle will prune smooth hollow-fibre membrane boundling other end sintering, and the other end upper cover after hollow-fibre membrane boundling sinters sets work
Skill lid B；Use syringe by AB glue injection technology lid B until AB glue from the gap that Technological cover B is combined with tubular shell
Overflow and stop injection, centrifugal solidification after the gas in AB glue in discharge Technological cover B；(7) use cutter machine by another for prominent tubular shell
The Technological cover B excision of one end, checks the flatness of tangent plane, surface quality, sets blood cap at the tangent plane upper cover machined；(8) exist
The seam crossing of tubular shell, tubular shell are coated with sealing seccotine formation and seal bonding with the seam crossing that blood cap connects, and obtain
Dialyser finished product.
The present invention provides one can effectively carry for superminiature dialyser and the manufacture method thereof of clinical zooscopy
The dialyser of high blood depuration efficiency and manufacture method thereof, installation space yarn between perineurium so that dialysis solution can be with dialyzer
Contact more fully, improve blood depuration efficiency.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of this programme dialyser.
Fig. 2 is this programme dialyser cross-sectional schematic.
Fig. 3 is the close-up schematic view in A portion in Fig. 2.
Fig. 4 is this programme dialyser cross-section profile schematic diagram.
Wherein, 100 is tubular shell, and 110 is dialysis solution outlet, and 120 is dialysis solution inlet tube, and 200 is entrance point blood
Cap, 210 is blood inlet pipe, and 300 is port of export blood cap, and 310 is blood outlet tube, and 400 is hollow-fibre membrane boundling,
410 is fluid sealant tissue A, and 420 is fluid sealant tissue B, and 500 is space yarn.
Detailed description of the invention
Below in conjunction with accompanying drawing, the invention will be further described.
As shown in figures 1-4, the present invention is for the superminiature dialyser schematic diagram of clinical zooscopy.For clinical animal
The superminiature dialyser of research includes tubular shell, and the capping of one end of tubular shell has entrance point blood cap, tubular shell another
One end capping has port of export blood cap, entrance point blood cap to be provided with blood inlet pipe, and port of export blood cap is provided with blood and goes out
Mouth pipe, the lateral wall of tubular shell one end is provided with dialysis solution outlet, and the lateral wall of the tubular shell other end is provided with dialysis
Liquid inlet tube, the inside of tubular shell is provided with hollow-fibre membrane boundling, and hollow-fibre membrane boundling includes a branch of hollow-fibre membrane, on
The one end stating a branch of hollow-fibre membrane is located on the inner side of tubular shell one end by fluid sealant tissue A envelope, an above-mentioned bundle of hollow
The other end of fibrous membrane is located on the inner side of the tubular shell other end by fluid sealant tissue B envelope, fluid sealant tissue A, fluid sealant
Tissue B, the inwall of tubular shell form the dialysis space closed, and dialysis solution outlet connects with dialysis space sealing, dialysis solution
Inlet tube connects with dialysis space sealing, and dialysis solution inlet tube, dialysis space, dialysis solution outlet form the dialysis liquid stream closed
Road, fluid sealant tissue A and entrance point blood cap form the blood inlet chamber closed, fluid sealant tissue B and port of export blood cap cover shape
Becoming the blood outlet plenum closed, blood inlet pipe seals with blood inlet chamber and connects, and blood outlet tube seals with blood outlet plenum
Connection, blood inlet pipe, blood inlet chamber, the membrane tube passage of hollow-fibre membrane boundling, blood outlet plenum, blood outlet tube are formed
Close blood flow passage, the perineurium of above-mentioned a branch of hollow-fibre membrane be interval with space yarn, dialysis solution through space yarn to film
Blood in tube passage is dialysed.Having blood to flow inside the hollow-fibre membrane of this programme, outside is dialysis solution flowing, at film
Interfascicular uses the structure in space yarn (space yarn), as shown in Figure 4 so that adjacent membranes interfascicular has certain space, it is ensured that dialysis
Liquid can flow between two films, and dialysis solution has with dialyzer and contacts more fully, is effectively improved blood depuration efficiency.Further,
For strengthening above-mentioned blood depuration efficiency, this programme can perineurium be preferably corrugated hollow-fibre membrane tubular construction, between perineurium
Every being provided with space yarn, the blood in membrane tube passage is dialysed by dialysis solution through space yarn.
The superminiature dialyser that this programme provides for solving clinical meiofauna blood purification experiment, it has blood room and holds
Measure little, good biocompatibility, the feature such as with low cost, easy and simple to handle.Accordingly, the dialyser of this programme has strict dimensionally
The length of requirement, specifically tubular shell, internal diameter, wall thickness are 170mm, 6mm, 2mm, simultaneously in order to ensure the efficiency of dialysis, this
The effective film area of the hollow-fibre membrane boundling of scheme is 0.02, and the total capacity of the membrane tube passage of hollow-fibre membrane boundling is formed
Blood chamber vol, blood chamber vol is 1.4ml.Therefore, the superminiature dialyser blood chamber vol of this programme is little, it is adaptable to meiofauna
The clinical blood purification techniques research of (such as rat).It addition, the dialyser of this programme can use disposable aseptic consumptive material,
Specifically tubular shell, entrance point blood cap, the material of port of export blood cap are makrolon materials, hollow-fibre membrane boundling
Material is polyether sulfone materials, and fluid sealant tissue A, fluid sealant tissue B are polyurethane adhesives.Makrolon material and polyether sulfone materials tool
There are good transparency and biocompatibility.In the housing of this programme parallel equipped with hundreds of polyethers more advanced than polysulfone membrane
Sulfone perineurium, instead of the isopropyl key in polysulfones molecule due to the oxygen-ether linkage in polyether sulfone materials molecular structure, and therefore it is hydrophilic
Property and heat-resisting, decay resistance improve further, reduce with protein adsorption during contacting blood, are especially contacting with strong oxidizer
Time, no longer produce methyl free radicals (human body can be produced a very large impact by residual), therefore there is more excellent biocompatibility.It addition,
The cinclides footpath of synthesizing polyether sulfone film is relatively big, higher to the permeability of water, and ultrafiltration rate is the biggest, the clearance rate of centering macromolecular toxins
Higher, it is possible to be effectively increased blood depuration efficiency.
The meiofauna blood content of clinical trial is less, and as a example by the rat of 250g, one time blood sampling volume is only a 8ml left side
Right.The effective film area that have developed of novelty of the present invention is only 0.02, and blood chamber vol is the superminiature dialyser of 1.4ml, tool
There is the blood chamber vol of 1.4ml, it is ensured that the operability of meiofauna blood extracorporeal circulation and safety, be used at part blood
Meiofauna other multinomial life index normal can be effectively ensured, it is adaptable to clinical meiofauna experiment during purging in vitro research
Research.The requirement of superminiature clearance of dialyzer see table.
Test condition: blood flow rate, dialysis solution flow rate and transmembrane pressure TMP empirically require to set.
The superminiature dialyser of this programme is omnidistance to be made 100,000 grades of cleaning shops, uses electron beam sterilization, does not affect material
Material performance on the premise of reach sterilizing purpose, have can reach dosage more accurately, to greatest extent reduce sterilizing to dialyser shadow
Ring, it is ensured that after sterilizing, properties of product are more excellent, and remain without sterilizing.Clinical experiment is verified, superminiature dialyser blood cap connects
Head is connected to form blood flow passage, exclusively for small-sized by pipeline with meiofauna dynamic (quiet) arteries and veins endovascular prosthesis, miniature pump line etc.
The dialysis solution of animal configurations connects with superminiature dialyser housing dialysis fluid side joint by the road and forms dialysis solution runner, builds little
The system of the outer blood purification of type animal body.Experimental result can meet the requirement of clearance rate.
The employing respective outer side edges that seals of this programme parts adds the combining form of fluid sealant, specifically outside tubular shell one end
Circumferentially arranged with fin ring structure A on wall, circumferentially arranged with groove ring structure A on entrance point blood cap medial wall, fin ring is tied
Structure A and groove ring structure A forms snap-fit A, and entrance point blood cap is fixed lid by snap-fit A and is located at tubular shell one end
On, the junction of entrance point blood cap and tubular shell one end is provided with macromolecule glue formation sealing lid and connects A, the tubular shell other end
Circumferentially arranged with fin ring structure B on lateral wall, circumferentially arranged with groove ring structure B, fin on port of export blood cap medial wall
Ring structure B and groove ring structure B forms snap-fit B, and port of export blood cap is fixed lid by snap-fit B and is located at tubular shell
On the other end, the junction of port of export blood cap and the tubular shell other end is provided with macromolecule glue formation sealing lid and meets B.I.e. we
The housing of case dialyser is tubulose, and it is protruding that two ends are provided with annular snap button, is connected by buckle with 2 blood caps respectively, and makes
With the macromolecule glue that adhesive property is good, housing is sealed with blood cap.Bigger dialyser typically housing and blood cap it
Between have O to seal, this programme saves O, reduces parts, improves efficiency while reducing cost of manufacture, can be really
Protect good sealing so that during clinical experiment, do not leak blood.This programme has also carried out other optimization and has processed, such as, and this programme
Tubular shell, entrance point blood cap, port of export blood cap inner surface burr height less than 0.05mm, blood inlet chamber,
The runner tapering of blood outlet plenum is 1:0.06, it is ensured that stable blood flowing.
The superminiature dialyser that this programme provides, for clinical meiofauna blood purification experiment, coordinates meiofauna blood volume
Less feature is researched and developed.Housing and blood cap in this programme use 3D printing technique molding, process hair inside ensureing postmenstruation
Thorn, less than 0.05mm, causes superminiature dialyser to use hourglass blood in order to avoid puncturing perineurium.Housing overall length 170mm, internal diameter 6mm, wall
Thick 2mm, draw ratio is 28.3.The joint being respectively arranged at two ends with dialysis solution inlet and outlet of housing side.Set in the middle of blood cap
Having the inlet and outlet of blood channel, the tapering of interface blood flow passage is 1:0.06, with international female Luer, it is ensured that steady
Fixed blood flowing.Hollow-fibre membrane uses drawing process to form, and perineurium makes waveform, increases space yarn, it is ensured that blood with
Dialysis solution is fully contacted, and reaches the purpose of blood purification.Hundreds of perineuriums being placed in housing, perineurium two ends are longer than shell
After the film part of body is sintered, hollow fiber conduit is i.e. shut airtight, through polyurethane adhesive fix bunchy and with housing two ends inside phase
Cohere.Exposing the untight doughnut mouth of pipe after cutting, blood cap is installed at two ends, and blood cap seals again with housing.
Use primary sterilization bag and be packaged.Carry out vanning and electron beam sterilization processes, complete the production of superminiature dialyser.
The invention also discloses the manufacture method of the above-mentioned superminiature dialyser for clinical zooscopy, including step:
By a branch of have set the hollow-fibre membrane boundling that is mingled with space yarn of quantity and be located in have and be sized
In tubular shell so that the length that tubular shell two ends are identical is stretched out at hollow-fibre membrane boundling two ends.Specifically can be by following
Mode is carried out.
Cleaning table top and staff's both hands.One people cuts off perineurium valve jacket with shears along sealing part, and both hands are by shell
Set is slowly pushed aside, makes perineurium spread out on table top motionless；Another people transfers to about 200 (range estimation) left gently in one end of perineurium
Right film, hand-tight pinch 200 films one section, an other hands is gently by 200 and whole bundle membrance separation, a clenching of the hand
One section of 200 films, another hands arranges perineurium, in disorder film and space yarn is axially extracted along perineurium, estimates film radical
If more than about 200, then extracted.Adhesive tape is cut into the rectangle of 15mm*35mm, the hands of 200 films made in order
Pinch end to wrap, clutch；The end of clutching of film is inserted housing gently, and a hands pinches housing and is suspended in the air, and another hands is pinched gently
Live perineurium to insert in housing, until perineurium exposes equal length at housing two ends.If tension when perineurium is inserted, can not be strong
Row pushes, in order to avoid causing film bending or rupture of membranes.Can take the film out, then remove a part of film of point, then reinsert.
(2) the hollow-fibre membrane boundling stretching out tubulose shell one end is pruned smooth, use flame gun by prune smooth in
Hollow fiber film boundling one end sinters, and one end upper cover after hollow-fibre membrane boundling sinters sets Technological cover A.Specifically can by with
Under type is carried out.
With shears, the exposed portion of non-for perineurium wrapped end is entirely cropped a part, make exposed portion length at 10mm
Left and right, then gently dials glutinous exposed portion together so that it is scatter with hands.Opening flame gun, flame is unsuitable long the most prosperous, on the other hand
Arrest dialyser slowly to rotate, another hand-held flame gun, allow flame vertical be sintered in perineurium, only with the flame of flame during sintering
Head touches perineurium top, and the first film that touches of flame is regained immediately, it is ensured that it is black that the Internal and external cycle of film has been sintered to concurrent xanthochromia the most.Burn
Perineurium exposed length after knot is 5～7mm.The film of sintering end is first put in Technological cover, and Technological cover withstands housing, with screw
Method, buttresses Technological cover on the other hand, the most firmly Technological cover is covered on housing, makes housing tip embed Technological cover 2～3mm deep
Degree.If sintering end has more breeze, available non-woven fabrics to dip in 75% ethanol, touch sintering end, breeze is absorbed.Avoid burning as far as possible
Film after knot touches anything and includes Technological cover.
(3) use the gap that syringe will be combined with tubular shell from Technological cover A in AB glue injection technology lid A until AB glue
Middle spilling stops injection, centrifugal solidification after the gas in AB glue in discharge Technological cover A.Specifically can carry out in the following manner.
Connect 50mlAB glue with sanitary cup, be quickly returning to workbench, pump full a pipe glue the most vertical with 2ml syringe
Syringe needle upwards, finger tap needle tubing, air in glue be discharged to syringe needle mouth release, take a dialyser at once, syringe needle inserted work
Skill lid duck eye, slowly injects emitter, and glue is squeezed in Technological cover, stops note when more than housing end face climbed to from Technological cover by glue
Glue, injecting glue amount is till filling Technological cover.Tear one piece of rectangular aluminium-foil paper of 50mm*60mm immediately, wrap the work after injecting glue
Skill lid, dialysis solution mouth must expose, and gives another one people dialyser, then repeats above-mentioned steps to next dialyser
Carry out injecting glue.Another people hands the most immediately pinches dialyser, and injecting glue one head erect is downward, taps the table, opens centrifugal solidification, fills
Point getting rid of the effect of air in glue, this step continues 5～10min/ heads.Dialyser after percussion is completed vertically is placed, and treats it
Spontaneous curing 24h.The position of air in Technological cover should be observed while injecting glue, if any bubble, syringe needle somewhat need to be extracted technique
Lid a little injects emitter injecting glue again, so air can be discharged Technological cover.Should vertically exert oneself during percussion, it is impossible to overexert, keep away
Exempt from the Technological cover to strike askew.
(4) use cutter machine Technological cover A of prominent tubular shell one end to be excised, check the flatness of tangent plane, surface matter
Amount, sets blood cap at the tangent plane upper cover machined.Specifically can carry out in the following manner.
Air pressure lathe plugs source of the gas, power initiation, adjusts cutter and fixture gap, dips in 75% alcohol wipe cutter with non-woven fabrics
Tool, fixture etc..Peelling off aluminium-foil paper, a people puts into dialyser in fixture, and Technological cover exposes fixture, pins dialyser on the other hand and shears
End, pins other end on the other hand.Other people's both hands are placed on lathe switch, listen the former by switch and to observe shearing matter by password
Amount.The former cuttves sheared can be rough cut thickness a bit, range estimation when switching to housing tip soon, should be noted that Technological cover can not expose folder
Tool is too many, cuts thinner, the most slightly cuts 3 cuttves, and essence cuts 5 cuttves, causes scrap in order to avoid switching to housing.After cutting the first end, take thoroughly
Parser carries out tangent plane inspection under ultramicroscope, it is desirable to select: membrane closure quantity less than 15/end, tangent plane is smooth draws without big
Trace, glue surface do not have big bubble.Often cut the 6th end face, it need to be carried out end face inspection, it is judged that whether cutter can also work,
If tangent plane is bad, then need tool changing.Last exhaustive test tangent plane under an electron microscope, rejects bad, carries out retroactive notation.Say
One end of passed examination is with on blood cap lid.The people of pressing necessarily can not expose fixture by handle, and the people of operation switch must listen
Pressing person's password switchs, it is ensured that safety.During shearing, due to fixture reason, dialyser slewing area is limited, but in order to shear matter
Amount, dialyser needs every partial application one angle of rotation to cut a cutter again.
(5) the hollow-fibre membrane boundling stretching out the tubular shell other end is pruned smooth, use flame gun smooth by pruning
The hollow-fibre membrane boundling other end sinters, and the other end upper cover after hollow-fibre membrane boundling sinters sets Technological cover B.Concrete operations
Mode is with step (2).
(6) use the gap that syringe will be combined with tubular shell from Technological cover B in AB glue injection technology lid B until AB glue
Middle spilling stops injection, centrifugal solidification after the gas in AB glue in discharge Technological cover B.Concrete operations mode is with step (3).
(7) use cutter machine Technological cover B of the prominent tubular shell other end to be excised, check the flatness of tangent plane, surface matter
Amount, sets blood cap at the tangent plane upper cover machined.Concrete operations mode is with step (4).
(8) the seam crossing being connected with blood cap at the seam crossing of tubular shell, tubular shell is coated with sealing seccotine and is formed close
Seal bonding, obtain dialyser finished product.Specifically can carry out in the following manner.
Along the seam of housing, the seam of blood cap and shell ends, uniform a glue must be coated with.Blood cap and body seam
It is too many that the glue at place should not be coated with, and can infilter in blood chamber too much, blocks fenestra, if space is excessive, needs many cementings,
Can divide and carry out several times.
Dialyser product also to process through following subsequent step after making further:
(9) dialyser finished product is carried out water leak detection, screen out substandard product, obtain qualified dialyser product.
(10) qualified dialyser product is put into microwave oven removal moisture drying, pack encapsulation after cooling.One pot 5, microwave enters
OK, drenched parser is lain in microwave oven, turn fire down 30 seconds.Take out immediately after completing and observe whether dialyser has difference.Treat
After dialyser cooling, by 2～4/packed enter sterilizing bag encapsulating.
(11) the qualified dialyser product after removal moisture drying is carried out sterilization treatment.Micro dialysis device must be with normal dialysis device
Sterilizing together, in order to avoid dosage exceeds standard, puts into micro dialysis device on the liner plate between two-layer normal dialysis device, is generally placed in white box
In.The case number (CN) of record sterilizing.
The concrete operation method related in the above-mentioned steps of this programme have employed manual mode, and this statement is not precluded from
The equipment such as special machine, such as programming Digit Control Machine Tool can be used to carry out the usability of automatic assembly line operation.Wherein relate to
And machinery equipment all can use the existing machinery equipment in this area, it is also possible to need employing to be specifically designed according to concrete operation
Machinery equipment and programming scheme.
The superminiature dialyser of this programme is mainly used in the effect machine of the most relevant blood purification technology treatment critical illness
System and the research for the treatment of principle, it is adaptable to the extracorporeal blood treatment field of meiofauna (such as rat), fill up domestic manufacturers
Not yet there is the blank that the product of correspondence commercially uses.This programme includes 1 for the superminiature dialyser of clinical zooscopy
Individual housing, 2 blood caps and hundreds of hollow-fibre membranes, perineurium two ends are fixed by polyurethane adhesive, and are connected with housing, housing
It is connected with blood cap and seals.Connected by buckle with blood cap by the housing of 3D printing technique molding, and use adhesive property
Good macromolecule glue makes housing seal with blood cap and substitutes conventional O sealing means.Employ and gather with space yarn
Ether sulfone hollow perineurium, blood flowing inside hollow membrane, outside is dialysis solution flowing, uses the structure of space yarn between perineurium, it is ensured that
Dialysis solution can flow between two films so that dialyzer has with dialysis solution and contacts more fully, improves blood depuration efficiency.Ultra micro
The effective film area of type dialyser is 0.02, and blood chamber vol is 1.4ml, and less blood chamber vol ensure that meiofauna blood
The operability of external liquid circulation and safety, it is adaptable to the research of clinical meiofauna experiment.The dialyser of this programme is omnidistance
Making 100,000 grades of cleaning shops, use electron beam sterilization, reach sterilizing purpose on the premise of not affecting material property, having can
With reach dosage more accurately, to greatest extent reduce sterilizing on dialyser affect, it is ensured that after sterilizing, properties of product are more excellent, and nothing
Sterilizing remains.The manufacture method of the micro dialysis device of this programme, has by multiple hollow fiber membranes in the housing of substantially tubular
The dialysis that the gap between gap and hollow membrane between blood pathway and this inner walls and hollow fiber membrane that chamber is formed is formed
Liquid stream road, manufacture method by film insertion, sintering, injecting glue, shear, be coated with fluid sealant, performance detection, be dried, encapsulation, the technique such as sterilizing
Composition, product is fine, and manufacture method is unified simple, manufactures qualification rate high, and operation is simple, material is unified, instrument is simple, cost
Low.Housing and blood cap use 3D printing technique molding, process burr inside ensureing postmenstruation and are less than 0.05mm, in order to avoid puncturing film
Shu Zaocheng superminiature dialyser uses hourglass blood.The manufacture method of this programme saves O, reduces parts, and reduction is fabricated to
Improve efficiency while Ben, can ensure that good sealing to make during clinical experiment and do not leak blood.Injecting glue operation in manufacture method
With needle cylinder injection, consumption is the most accurate, and sterilization method uses electron beam sterilization technology, and sterilization effect is more preferably.
Based on above feature, a kind of superminiature dialyser for clinical zooscopy of this programme and manufacture method phase thereof
Than existing similar design, there is prominent substantive distinguishing features and significantly progress.
A kind of superminiature dialyser for clinical zooscopy of this programme and manufacture method thereof are not limited to concrete reality
Executing the content disclosed in mode, the technical scheme occurred in product embodiments can be with individualism, it is also possible to mutually comprise, its bag
The operating procedure contained, on the premise of not violating technical specification and principle, can carry out suitable order tune for optimizing operation sequence
Changing, those skilled in the art combine, according to this programme, the simple alternative that common knowledge makes and fall within the scope of this programme.
Claims (10)
1., for a superminiature dialyser for clinical zooscopy, it is characterized in that including tubular shell, described tubular shell
One end capping has entrance point blood cap, and the other end capping of described tubular shell has port of export blood cap, described entrance point blood cap
Covering and be provided with blood inlet pipe, described port of export blood cap is provided with blood outlet tube, the lateral wall of described tubular shell one end
Being provided with dialysis solution outlet, the lateral wall of the described tubular shell other end is provided with dialysis solution inlet tube, described tubular shell
Inside be provided with hollow-fibre membrane boundling, described hollow-fibre membrane boundling includes a branch of hollow-fibre membrane, and a described bundle of hollow is fine
One end of dimension film is located on the inner side of described tubular shell one end by fluid sealant tissue A envelope, described a branch of hollow-fibre membrane
The other end is located on the inner side of the described tubular shell other end by fluid sealant tissue B envelope, described fluid sealant tissue A, fluid sealant
Tissue B, the inwall of tubular shell form the dialysis space closed, and described dialysis solution outlet is with described dialysis space sealing even
Logical, described dialysis solution inlet tube connects with described dialysis space sealing, and described dialysis solution inlet tube, dialysis space, dialysis solution go out
Mouth pipe forms the dialysis solution runner closed, and described fluid sealant tissue A forms the blood inlet of closing with described entrance point blood cap
Chamber, described fluid sealant tissue B forms, with described port of export blood cap, the blood outlet plenum closed, and described blood inlet pipe is with described
Blood inlet chamber seals connection, and described blood outlet tube seals with described blood outlet plenum and connects, described blood inlet pipe, blood
Snout cavity, the membrane tube passage of hollow-fibre membrane boundling, blood outlet plenum, blood outlet tube form the blood flow passage closed, described
The perineurium of a branch of hollow-fibre membrane be interval with space yarn, dialysis solution through described space yarn to the blood in described membrane tube passage
Liquid is dialysed.
Superminiature dialyser for clinical zooscopy the most according to claim 1, it is characterised in that described tubular shell
The length of body, internal diameter, wall thickness are 170mm, 6mm, 2mm.
Superminiature dialyser for clinical zooscopy the most according to claim 2, it is characterised in that described hollow is fine
The effective film area of dimension film boundling is 0.02, and the total capacity of the membrane tube passage of described hollow-fibre membrane boundling forms blood room and holds
Amount, described blood chamber vol is 1.4ml.
Superminiature dialyser for clinical zooscopy the most according to claim 2, it is characterised in that described tubular shell
Body, entrance point blood cap, the inner surface burr height of port of export blood cap are less than 0.05mm.
Superminiature dialyser for clinical zooscopy the most according to claim 1, it is characterised in that described blood enters
Oral cavity, the runner tapering of blood outlet plenum are 1:0.06.
Superminiature dialyser for clinical zooscopy the most according to claim 1, it is characterised in that described tubular shell
Circumferentially arranged with fin ring structure A on lateral wall, body one end, circumferentially arranged with groove ring on described entrance point blood cap medial wall
Structure A, described fin ring structure A forms snap-fit A with described groove ring structure A, and described entrance point blood cap is by described
Snap-fit A is fixed lid and is located on described tubular shell one end, described entrance point blood cap and the company of described tubular shell one end
The place of connecing is provided with macromolecule glue formation sealing lid and meets A, circumferentially arranged with fin ring structure on described tubular shell other end lateral wall
B, circumferentially arranged with groove ring structure B on described port of export blood cap medial wall, described fin ring structure B is tied with described groove ring
Structure B forms snap-fit B, described port of export blood cap by described snap-fit B fix lid be located at described tubular shell another
On end, the junction of described port of export blood cap and the described tubular shell other end is provided with macromolecule glue formation sealing lid and meets B.
Superminiature dialyser for clinical zooscopy the most according to claim 1, it is characterised in that described perineurium is
Corrugated hollow-fibre membrane tubular construction, described perineurium be interval with space yarn, dialysis solution through described space yarn to described
Blood in membrane tube passage is dialysed.
Superminiature dialyser for clinical zooscopy the most according to claim 1, it is characterised in that described tubular shell
Body, entrance point blood cap, the material of port of export blood cap are makrolon materials, and the material of described hollow-fibre membrane boundling is poly-
Ether sulfone material, described fluid sealant tissue A, fluid sealant tissue B are polyurethane adhesives.
It is used for the manufacture method of the superminiature dialyser of clinical zooscopy the most according to claim 1, it is characterized in that including
Step:
(1) a branch of hollow-fibre membrane boundling being mingled with space yarn with setting quantity is located in and there is the tubulose being sized
In housing so that the length that tubular shell two ends are identical is stretched out at hollow-fibre membrane boundling two ends；
(2) the hollow-fibre membrane boundling stretching out tubulose shell one end is pruned smooth, use flame gun fine by pruning smooth hollow
Dimension film boundling one end sintering, one end upper cover after hollow-fibre membrane boundling sinters sets Technological cover A；
(3) use syringe will to overflow from the gap that Technological cover A is combined with tubular shell until AB glue in AB glue injection technology lid A
Go out and stop injection, centrifugal solidification after the gas in AB glue in discharge Technological cover A；
(4) use cutter machine Technological cover A of prominent tubular shell one end to be excised, check the flatness of tangent plane, surface quality,
The tangent plane upper cover machined sets blood cap；
(5) the hollow-fibre membrane boundling stretching out the tubular shell other end is pruned smooth, use flame gun will prune smooth hollow
The fibrous membrane boundling other end sinters, and the other end upper cover after hollow-fibre membrane boundling sinters sets Technological cover B；
(6) use syringe will to overflow from the gap that Technological cover B is combined with tubular shell until AB glue in AB glue injection technology lid B
Go out and stop injection, centrifugal solidification after the gas in AB glue in discharge Technological cover B；
(7) use cutter machine Technological cover B of the prominent tubular shell other end to be excised, check the flatness of tangent plane, surface quality,
Blood cap is set at the tangent plane upper cover machined；
(8) the seam crossing being connected with blood cap at the seam crossing of tubular shell, tubular shell be coated with sealing seccotine formed seal viscous
Connect, obtain dialyser finished product.
The manufacture method of the superminiature dialyser for clinical zooscopy the most according to claim 9, is characterized in that institute
State manufacture method and also include subsequent step:
(9) dialyser finished product is carried out water leak detection, screen out substandard product, obtain qualified dialyser product；
(10) qualified dialyser product is put into microwave oven removal moisture drying, pack encapsulation after cooling；
(11) the qualified dialyser product after removal moisture drying is carried out sterilization treatment.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112826998A (en) * | 2020-12-24 | 2021-05-25 | 健帆生物科技集团股份有限公司 | Batch production control method for dialyzers, dialysis system and batch production dialyzer management method |
| CN117504026A (en) * | 2023-12-25 | 2024-02-06 | 天津大学 | Oxygenator assembly for extracorporeal membrane oxygenation |
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| CN117504026B (en) * | 2023-12-25 | 2024-05-07 | 天津大学 | Oxygenator assembly for extracorporeal membrane oxygenation |
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|---|---|
| CN106039445B (en) | 2019-01-04 |
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