CN106039445B - A kind of superminiature dialyzer and its manufacturing method for clinical zooscopy - Google Patents
A kind of superminiature dialyzer and its manufacturing method for clinical zooscopy Download PDFInfo
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- CN106039445B CN106039445B CN201610676398.XA CN201610676398A CN106039445B CN 106039445 B CN106039445 B CN 106039445B CN 201610676398 A CN201610676398 A CN 201610676398A CN 106039445 B CN106039445 B CN 106039445B
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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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- Urology & Nephrology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The present invention relates to a kind of superminiature dialyzers for clinical zooscopy, including tubular shell, the both ends capping of tubular shell has input end blood cap, outlet end blood cap, input end blood cap is equipped with blood inlet pipe, outlet end blood cap is equipped with blood outlet tube, the lateral wall at tubular shell both ends is equipped with dialyzate outlet, dialyzate inlet tube, and the inside of tubular shell is equipped with hollow-fibre membrane boundling, and the perineurium of hollow-fibre membrane is equipped at intervals with space yarn.The invention also discloses the manufacturing method of above-mentioned dialyzer, including film insertion, one end sintering, cover process lid, injecting glue, solidification, shearing, lid blood cap, the sintering of two ends, cover process lid, two end injecting glues, solidification, the shearing of two ends, cover process lid, apply sealant.The present invention provides dialyzer and its manufacturing method that one kind can effectively improve blood depuration efficiency, the installation space yarn between perineurium enables dialyzate more fully to contact with dialysis membrane, improves blood depuration efficiency.
Description
Technical field
The present invention relates to a kind of dialyzer and its manufacturing method, in particular to a kind of superminiature for clinical zooscopy
Dialyzer and its manufacturing method belong to dialyzer field.
Background technique
Clinical common critical syndrome has acute kidney injury, liver failure, heart failure, acute lung injury etc..Cause
It is mostly stopped with hemodynamic instability, organ hypoperfusion, systemic inflammatory response syndrome or even pyemia, septic
Gram etc. common pathophysiological change, finally easily develop 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, disease incidence and
The death rate is higher, and the treatment of such disease spends big, poor prognosis, is the problem for perplexing various countries' severe medical expert.
Blood purification technology is the principle using semi-permeable membrane, by disperse and (or) convection current, carries out solute exchange and moisture
The blood purification treatment method of removing has and removes moisture extra in vivo, maintains Water-Electrolyte and acid-base balance, keeps inner ring
Border is stablized, while the features such as can remove inside and outside source property noxious material and certain inflammatory mediators.Blood purification is treatment critical illness
Important means, mainly include haemodialysis, blood filtering, hemodiafiltration, blood perfusion and plasma exchange etc..It is not
It is only a kind of kidney substitute technology, the effect of Multi-organ systems life support is more played in patient with severe symptoms, it has also become critical illness is anxious
Rescue the important component of medicine.
But the Mechanisms and therapy principle of related blood purification technology treatment critical illness is not readily apparent from still, at present also
Need further to be studied there are many critical issue of dialysis, such as blood purification opportunity, blood purification mode difference, rationally
Therapeutic dose, reasonable therapic opportunity, the loss of nutriment, the influence to body's immunity.Due to being set by experiment
The limitation of standby and material, what domestic and international application was most at present is large-scale experiment animal (such as pig, dog, sheep, ox) or medium-sized dynamic
Object (such as rabbit).These zooperies are at high cost, operating difficulties, the animal reproduction period is long, raising is difficult, lack species specificity
The factors such as detection kit greatly limit the development and improvement of blood purification technology.And using rat as the meiofauna of representative
Blood purification then has relative inexpensiveness, can carry out on a large scale, can repeatedly sample of tissue, be appropriate for blood purification treatment machine
The advantages that system research, detection kit be complete, a variety of critical disease models are more mature.But in meiofauna body total blood volume compared with
Few, primary dialyzable blood volume is less in blood purification clinical test, also more demanding to the efficiency of haemodialysis, is suitable for
The haemodialyser of large-scale experiment animal is no longer satisfied requirement.
Summary of the invention
The present invention is used for the superminiature dialyzer of clinical zooscopy and its manufacturing method discloses new scheme, provides
A kind of dialyzer that can effectively improve blood depuration efficiency and its manufacturing method, solving existing dialyzer may not apply to pair
The problem of haemodialysis efficiency requirements higher meiofauna.
The superminiature dialyzer that the present invention is used for clinical zooscopy includes tubular shell, and one end capping of tubular shell has
The other end capping of input end blood cap, tubular shell has outlet end blood cap, and input end blood cap is equipped with blood inlet pipe,
Outlet end blood cap is equipped with blood outlet tube, and the lateral wall of tubular shell one end is equipped with dialyzate outlet, tubular shell
The lateral wall of the other end is equipped with dialyzate inlet tube, and the inside of tubular shell is equipped 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 sealant tissue A envelope
On the inside of one end, the other end of above-mentioned a branch of hollow-fibre membrane is located at the tubular shell other end by sealant tissue B envelope
On inside, sealant tissue A, sealant tissue B, tubular shell inner wall form closed dialysis space, dialyzate outlet
It is connected to dialysis space sealing, dialyzate inlet tube is connected to dialysis space sealing, dialyzate inlet tube, dialysis space, dialysis
Liquid outlet forms closed dialyzate runner, and sealant tissue A and input end blood cap form closed blood inlet chamber, close
Sealing tissue B and outlet end blood cap form closed blood outlet plenum, and blood inlet pipe is connected to the sealing of blood inlet chamber, blood
The sealing of liquid outlet and blood outlet plenum is connected to, blood inlet pipe, blood inlet chamber, hollow-fibre membrane boundling membrane tube channel,
Blood outlet plenum, blood outlet tube form closed blood flow passage, and the perineurium of above-mentioned a branch of hollow-fibre membrane is equipped at intervals with sky
Between yarn, dialyzate dialyses to the blood in membrane tube channel through space yarn.
The invention also discloses the manufacturing methods of the above-mentioned superminiature dialyzer for clinical zooscopy, comprising steps of
(1) a branch of hollow-fibre membrane boundling for being mingled with space yarn with setting quantity is threaded through with the tubular shell being sized
It is interior, so that the identical length in tubular shell both ends is stretched out at hollow-fibre membrane boundling both ends；(2) will stretch out in tubular shell one end
Empty fiber membrane boundling is pruned smooth, will prune smooth hollow-fibre membrane boundling one end using flame gun and be sintered, in doughnut
The sintered one end upper cover of film boundling sets Technological cover A；Using syringe by AB glue injection technology lid A until AB glue is from technique
It covers A and is overflowed in the gap in conjunction with tubular shell and stop injection, be centrifuged solidification after the gas in Technological cover A in AB glue is discharged；⑷
The Technological cover A of prominent tubular shell one end is cut off using cutter machine, flatness, the surface quality of section is checked, is processing
At section upper cover set blood cap；(5) the hollow-fibre membrane boundling for stretching out the tubular shell other end is pruned smooth, use flame
Rifle is sintered the smooth hollow-fibre membrane boundling other end is pruned, and sets work in the sintered other end upper cover of hollow-fibre membrane boundling
Skill lid B；Using syringe by AB glue injection technology lid B until AB glue from Technological cover B in gap in conjunction with tubular shell
It overflows and stops injection, be centrifuged solidification after the gas in Technological cover B in AB glue is discharged；(7) it will be another tubular shell will to be protruded using cutter machine
The Technological cover B of one end is cut off, and is checked flatness, the surface quality of section, is set blood cap in the section upper cover completed the process；(8) exist
The seam crossing of tubular shell, tubular shell and the seam crossing that blood cap connects are coated with sealing seccotine to form sealing Nian Jie, obtain
Dialyzer finished product.
The present invention is used for the superminiature dialyzer of clinical zooscopy and its manufacturing method provides one kind and can effectively mention
The dialyzer and its manufacturing method of high blood depuration efficiency, the installation space yarn between perineurium enable dialyzate and dialysis membrane
It more fully contacts, improves blood depuration efficiency.
Detailed description of the invention
Fig. 1 is the schematic diagram of this programme dialyzer.
Fig. 2 is this programme dialyzer schematic cross-sectional view.
Fig. 3 is the partial enlargement diagram in the portion A in Fig. 2.
Fig. 4 is this programme dialyzer cross-section profile schematic diagram.
Wherein, 100 be tubular shell, and 110 be dialyzate outlet, and 120 be dialyzate inlet tube, and 200 be input end blood
Cap, 210 be blood inlet pipe, and 300 be outlet end blood cap, and 310 be blood outlet tube, and 400 be hollow-fibre membrane boundling,
410 be sealant tissue A, and 420 be sealant tissue B, and 500 be space yarn.
Specific embodiment
Below in conjunction with attached drawing, the invention will be further described.
As shown in figures 1-4, the present invention is used for the superminiature dialyzer schematic diagram of clinical zooscopy.For clinical animal
The superminiature dialyzer of research includes tubular shell, and one end capping of tubular shell has an input end blood cap, tubular shell it is another
One end capping has outlet end blood cap, and input end blood cap is equipped with blood inlet pipe, and outlet end blood cap goes out equipped with blood
Mouth pipe, the lateral wall of tubular shell one end are equipped with dialyzate outlet, and the lateral wall of the tubular shell other end is equipped with dialysis
The inside of liquid inlet tube, tubular shell is equipped with hollow-fibre membrane boundling, and hollow-fibre membrane boundling includes a branch of hollow-fibre membrane, on
The one end for stating a branch of hollow-fibre membrane is located on the inside of tubular shell one end by sealant tissue A envelope, an above-mentioned bundle of hollow
The other end of tunica fibrosa is located on the inside of the tubular shell other end by sealant tissue B envelope, sealant tissue A, sealant
Tissue B, tubular shell inner wall form closed dialysis space, dialyzate outlet is connected to space sealing of dialysing, dialyzate
Inlet tube is connected to dialysis space sealing, and dialyzate inlet tube, dialysis space, dialyzate outlet form closed dialysis liquid stream
Road, sealant tissue A and input end blood cap form closed blood inlet chamber, sealant tissue B and outlet end blood cap cover shape
At closed blood outlet plenum, blood inlet pipe is connected to the sealing of blood inlet chamber, and blood outlet tube and blood outlet plenum seal
Connection, blood inlet pipe, blood inlet chamber, the membrane tube channel of hollow-fibre membrane boundling, blood outlet plenum, blood outlet tube are formed
Closed blood flow passage, the perineurium of above-mentioned a branch of hollow-fibre membrane are equipped at intervals with space yarn, and dialyzate is through space yarn to film
Blood in tube passage is dialysed.There is blood flow on the inside of the hollow-fibre membrane of this programme, outside is dialyzate flowing, in film
The construction of interfascicular use space yarn (space yarn), as shown in figure 4, adjacent membranes interfascicular is made to have certain space, it is ensured that dialysis
Liquid can flow between two films, and dialyzate has with dialysis membrane more fully to be contacted, and effectively improve blood depuration efficiency.Further,
To enhance above-mentioned blood depuration efficiency, this programme can preferably perineurium be wavy hollow fiber film tube structure, between perineurium
Every being equipped with space yarn, dialyzate dialyses to the blood in membrane tube channel through space yarn.
This programme is the superminiature dialyzer for solving clinical meiofauna blood purification experiment and providing, it holds with blood room
Measure small, good biocompatibility, it is low in cost, easy to operate the features such as.Accordingly, the dialyzer of this programme dimensionally has stringent
It is required that the length of specifically tubular shell, internal diameter, wall thickness are 170mm, 6mm, 2mm, while in order to guarantee the efficiency dialysed, this
Effective membrane area of the hollow-fibre membrane boundling of scheme is 0.02 ㎡, and the total capacity in the membrane tube channel of hollow-fibre membrane boundling is formed
Blood chamber vol, blood chamber vol are 1.4ml.Therefore, the superminiature dialyzer blood chamber vol of this programme is small, is suitable for meiofauna
The clinical blood purification techniques of (such as rat) is studied.In addition, disposable sterile consumptive material can be used in the dialyzer of this programme,
Specifically tubular shell, input end blood cap, outlet end blood cap material be makrolon material, hollow-fibre membrane boundling
Material is polyether sulfone materials, and sealant tissue A, sealant tissue B are polyurethane adhesives.Makrolon material and polyether sulfone materials tool
There are good transparency and biocompatibility.Hundreds of polyethers more more advanced than PS membrane are housed in parallel in the shell of this programme
Sulfone perineurium, it is hydrophilic since the oxygen-ether linkage in polyether sulfone materials molecular structure is instead of the isopropyl key in polysulfones molecule
Property and heat-resisting, corrosion resistance can be further improved, and reduce with protein adsorption when contacting blood, especially contact with strong oxidizer
When, methyl free radicals (residual can produce a very large impact human body) is no longer generated, therefore there is more preferably biocompatibility.In addition,
The cinclides diameter of synthesizing polyether sulfone film is larger, higher to the permeability of water, and ultrafiltration rate is also larger, the clearance rate of centering macromolecular toxins
It is higher, blood depuration efficiency can also be effectively increased.
The meiofauna blood content of clinical test is smaller, and by taking the rat of 250g as an example, a blood sampling volume is only the left side 8ml
It is right.Innovative effective membrane area that has developed of the invention is only 0.02 ㎡, and blood chamber vol is the superminiature dialyzer of 1.4ml, tool
There is the blood chamber vol of 1.4ml, ensure that the operability and safety of meiofauna blood extracorporeal circulation, blood is used in part
The normal of meiofauna other multinomial life index can be effectively ensured in purging in vitro when studying, be suitable for clinical meiofauna experiment
Research.The requirement of superminiature clearance of dialyzer see the table below.
Test condition: blood flow rate, dialyzate flow rate and transmembrane pressure TMP are set by requirement of experiment.
The superminiature dialyzer whole process of this programme makes 100,000 grades of cleaning shops, using electron beam sterilization, does not influence material
Reach sterilizing purpose under the premise of material performance, dosage is more accurate, reduction sterilizes to dialyzer shadow to greatest extent with can achieve
It rings, properties of product are more excellent after ensure that sterilizing, and remain without sterilizing.Clinical trial verifying, superminiature dialyzer blood cap connect
Head moves (quiet) arteries and veins endovascular prosthesis, miniature pump line etc. by pipeline and meiofauna and is connected to form blood flow passage, exclusively for small-sized
The dialyzate of animal configurations connects to forming dialyzate runner with superminiature dialyzer shell dialysis fluid side connector by the road, constructs small
The system of the outer blood purification of type animal body.Experimental result can meet the requirement of clearance rate.
The sealing of this programme component is using the combining form of structure cooperation encryption sealing, specifically tubular shell one end outside
Circumferentially arranged with fin ring structure A on wall, circumferentially arranged with groove ring structure A, fin ring knot on input end blood cap inner sidewall
Structure A and groove ring structure A forms snap-fit A, and input end blood cap is located at tubular shell one end by the fixed lid of snap-fit A
On, the junction of input end blood cap and tubular shell one end is equipped with macromolecule glue formation sealing cover 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 the blood cap inner sidewall of outlet end
Ring structure B and groove ring structure B forms snap-fit B, and outlet end blood cap is located at tubular shell by the fixed lid of snap-fit B
On the other end, the junction of outlet end blood cap and the tubular shell other end is equipped with macromolecule glue formation sealing cover and meets B.It is i.e. our
The shell of case dialyzer is tubulose, and both ends are equipped with annular buckle-type protrusion, are connected respectively with 2 blood caps by buckle, and make
With adhesive property good macromolecule glue shell and blood cap are sealed.Biggish dialyzer generally shell and blood cap it
Between there is O-ring to be sealed, this programme saves O-ring, reduces components, improves efficiency while reducing cost of manufacture, can be really
Good leakproofness is protected, so that not leaking blood when clinical trial.This programme has also carried out other optimization processings, for example, this programme
Tubular shell, input end blood cap, outlet end blood cap inner surface burr height be less than 0.05mm, blood inlet chamber,
The runner taper of blood outlet plenum is 1:0.06, guarantees stable blood flow.
The superminiature dialyzer that this programme provides is used for clinical meiofauna blood purification experiment, cooperates meiofauna blood volume
Less feature research and development.Shell and blood cap in this programme are formed using 3D printing technique, and postmenstruation processing guarantees inside hair
Thorn is less than 0.05mm, causes to leak blood when superminiature dialyzer use in order to avoid puncturing perineurium.Shell overall length 170mm, internal diameter 6mm, wall
Thick 2mm, draw ratio 28.3.The both ends of shell side are respectively equipped with the connector of dialyzate inlet and outlet.It is set among blood cap
There is the inlet and outlet of blood channel, the taper of interface blood flow passage is 1:0.06, with international female Luer, is guaranteed steady
Fixed blood flow.Hollow-fibre membrane is formed using drawing process, and perineurium is made waveform, increases space yarn, it is ensured that blood with
Dialyzate is come into full contact with, and achievees the purpose that blood purification.Hundreds of perineuriums are placed in shell, perineurium both ends are longer than shell
After the membrane part of body is sintered, hollow fiber conduit shut it is closed, through the fixed bunchy of polyurethane adhesive and with phase on the inside of shell both ends
It coheres.Expose unclosed doughnut nozzle after cutting, blood cap is installed at both ends, and blood cap is sealed again with shell.
Using primary sterilization bag and it is packaged.Vanning and electron beam sterilization processing are carried out, the production of superminiature dialyzer is completed.
The invention also discloses the manufacturing methods of the above-mentioned superminiature dialyzer for clinical zooscopy, comprising steps of
(1) a branch of hollow-fibre membrane boundling for being mingled with space yarn with setting quantity is threaded through with being sized
In tubular shell, so that the identical length in tubular shell both ends is stretched out at hollow-fibre membrane boundling both ends.It specifically can be by following
Mode carries out.
Cleaning table top and staff's both hands.One people cuts off perineurium valve jacket along sealing part with scissors, and both hands are by shell
Set is slowly pushed aside, spreads perineurium out motionless on table top；Another people gently transfers to about 200 (range estimation) left sides in one end of perineurium
Right film, hand-tight one section for pinching 200 films, in addition a hand is gently by 200 and whole beam UF membrane, a clenching of the hand
One section of 200 films, another hand arrange perineurium, and in disorder film and space yarn are axially extracted along perineurium, estimate film radical
If being more than 200 or so, extract.Adhesive tape is cut into the rectangle of 15mm*35mm, the hand for 200 films made in order
End is pinched to wrap, clutch；Shell is gently inserted at the end of clutching of film, a hand pinches shell and is suspended in the air, and another hand is gently pinched
Firmly in perineurium insertion shell, until perineurium is until equal length is exposed at shell both ends.If tension when perineurium is inserted into, can not be strong
Row push-in, in order to avoid cause film bending or rupture of membranes.It can take the film out, then remove a little a part of film, then reinsert.
(2) the hollow-fibre membrane boundling for stretching out tubular shell one end is pruned smooth, will be pruned in smooth using flame gun
The sintering of empty fiber membrane boundling one end, sets Technological cover A in the sintered one end upper cover of hollow-fibre membrane boundling.Specifically can by with
Under type carries out.
The exposed portion of the non-wrapped end of perineurium is entirely cropped a part with scissors, makes exposed portion length in 10mm
Then left and right gently dials glutinous exposed portion together with hand, it is made to scatter.Flame gun is opened, flame is unsuitable too long excessively prosperous, on the other hand
It holds dialyzer slowly to rotate, the other hand takes flame gun, and flame vertical is allowed to be sintered in perineurium, and when sintering only uses the flame of flame
Head touches perineurium top, and flame front one touches film and withdraws immediately, it is ensured that it is black that the Internal and external cycle of film has all been sintered to concurrent xanthochromia.It burns
Perineurium exposed length after knot is in 5~7mm.The film at sintering end is first put into Technological cover, Technological cover withstands shell, with what is screwed
Method buttresses Technological cover on the other hand, firmly Technological cover is covered on shell on the other hand, keeps housing tip insertion 2~3mm of Technological cover deep
Degree.If there is more breeze at sintering end, 75% alcohol can be dipped in non-woven fabrics, touch sintering end, breeze is absorbed.It avoids burning as far as possible
It includes Technological cover that film after knot, which touches anything,.
(3) use syringe by the gap in AB glue injection technology lid A until AB glue from Technological cover A in conjunction with tubular shell
Middle spilling stops injection, is centrifuged solidification after the gas in Technological cover A in AB glue is discharged.It can specifically carry out in the following manner.
50mlAB glue is connect with sanitary cup, is quickly returning to workbench, pumps full a pipe glue and vertical at once with 2ml syringe
Syringe needle is upward, and finger touches needle tubing, and air in glue is discharged to syringe needle mouth and is released, a dialyzer is taken at once, syringe needle is inserted into work
Skill lid duck eye, slowly injects emitter, glue is squeezed into Technological cover, infuses when glue from stopping when climbing to shell end face or more in Technological cover
Glue, injecting glue amount is until filling Technological cover.One piece of rectangular aluminium-foil paper of 50mm*60mm, the work after wrapping injecting glue are torn immediately
Skill lid, dialyzate mouth must expose, and give another people dialyzer, then repeat above-mentioned steps to next dialyzer
Carry out injecting glue.Then hand pinches dialyzer to another people immediately, and one head erect of injecting glue is downward, taps the table, and opens centrifugation solidification, fills
Divide the effect for excluding air in glue, which continues 5~10min/ head.Dialyzer after the completion of percussion is placed vertically, to it
Spontaneous curing is for 24 hours.Syringe needle need to slightly be extracted technique if any bubble by the position that air in Technological cover should be observed while injecting glue
Lid a little injects emitter injecting glue again, Technological cover can be discharged in air in this way.It should vertically exert oneself when percussion, cannot overexert, keep away
Exempt from Technological cover to strike askew.
(4) the Technological cover A of prominent tubular shell one end is cut off using cutter machine, check flatness, the surface matter of section
Amount, sets blood cap in the section upper cover completed the process.It can specifically carry out in the following manner.
Air pressure lathe plugs gas source, power initiation, adjustment knife and fixture gap, dips in 75% alcohol wipe knife with non-woven fabrics
Tool, fixture etc..Aluminium-foil paper is peelled off, a people is put into dialyzer in fixture, and Technological cover exposes fixture, pins dialyzer shearing on the other hand
End, pins other end on the other hand.Other people both hands are placed on lathe switch, listen the former password by switching and observe shearing matter
Amount.Former knives of shearing can cut roughly thickness a bit, when range estimation switches to housing tip fastly, should be noted that Technological cover cannot expose folder
Tool is too many, cuts thinner, generally slightly cuts 3 knives, 5 knife of fine cut causes to scrap in order to avoid switching to shell.After cutting first end, take saturating
Section inspection is carried out under parser to electron microscope, it is desirable that point: film closes quantity stroke big less than 15/end, the smooth nothing in section
The not big bubble of trace, glue surface.The 6th end face is often cut, end face inspection need to be carried out to it, judge whether cutter can also work,
If section is bad, tool changing is needed.Last exhaustive test section under an electron microscope, rejecting is bad, carries out retroactive notation.It says
One end of passed examination is covered with blood cap.The people of pressing is centainly unable to handle and exposes fixture, and the people of Operation switch has to listen
Pressing person's password switch, guarantees safety.When shearing, due to fixture reason, dialyzer slewing area is limited, but in order to shear matter
Amount, dialyzer need one angle of every partial application rotation to cut a knife again.
(5) the hollow-fibre membrane boundling for stretching out the tubular shell other end is pruned smooth, will be pruned using flame gun smooth
The sintering of the hollow-fibre membrane boundling other end, sets Technological cover B in the sintered other end upper cover of hollow-fibre membrane boundling.Concrete operations
Mode with step (2).
(6) use syringe by the gap in AB glue injection technology lid B until AB glue from Technological cover B in conjunction with tubular shell
Middle spilling stops injection, is centrifuged solidification after the gas in Technological cover B in AB glue is discharged.Concrete operations mode with step (3).
(7) the Technological cover B of the prominent tubular shell other end is cut off using cutter machine, check flatness, the surface matter of section
Amount, sets blood cap in the section upper cover completed the process.Concrete operations mode with step (4).
The seam crossing of tubular shell, tubular shell and blood cap connection seam crossing be coated with sealing seccotine formed it is close
Envelope bonding, obtains dialyzer finished product.It can specifically carry out in the following manner.
It is uniform to apply a glue along the seam of shell, the seam of blood cap and shell ends.Blood cap and body seam
The glue at place should not apply too many, can infilter in blood chamber if too many, and blocking fenestra if gap is excessive needs overbrushing glue,
It can divide and carry out several times.
Dialyzer product will be also further processed after being made by following subsequent step:
(9) dialyzer finished product is subjected to water leak detection, screens out substandard product, obtain qualified dialyzer product.
(10) qualified dialyzer product is put into removal moisture drying in micro-wave oven, packs encapsulation after cooling.One pot 5, microwave into
Row, drenched parser is lain in micro-wave oven, turns fire down 30 seconds.Whether the dialyzer of taking-up observation immediately has abnormal after the completion.To
After dialyzer is cooling, by 2~4/packed enter sterilizing bag and to encapsulate.
(11) the qualified dialyzer product after removal moisture drying is subjected to sterilization treatment.Micro dialysis device must be with normal dialysis device
It sterilizes together, in order to avoid dosage is exceeded, micro dialysis device is put on the liner plate between two layers of normal dialysis device, white box is generally placed in
It is interior.Record the case number (CN) of sterilizing.
By the way of manual, this statement is not precluded concrete operation method involved in the above-mentioned steps of this programme
The usability that the equipment such as special machine, such as programming numerically-controlled machine tool carry out automatic assembly line operation can be used.Wherein relate to
And machinery equipment the existing machinery equipment in this field can be used, can also be needed according to specific operation using being specifically designed
Machinery equipment and programming scheme.
The superminiature dialyzer of this programme is mainly used for the effect machine of clinically related blood purification technology treatment critical illness
The research of system and treatment principle, is suitable for the extracorporeal blood treatment field of meiofauna (such as rat), fills up domestic manufacturers
There has been no the blank that corresponding product uses on the market.The superminiature dialyzer that this programme is used for clinical zooscopy includes 1
A shell, 2 blood caps and hundreds of hollow-fibre membranes, perineurium both ends are fixed by polyurethane adhesive, and are connected with shell, shell
It is connected and seals with blood cap.Connected with blood cap by buckle by the molding shell of 3D printing technique, and uses adhesive property
Good macromolecule glue makes shell and blood cap seal the common O-ring sealing means of substitution.It has used poly- with space yarn
The hollow perineurium of ether sulfone, hollow membrane inside blood flow, outside are dialyzate flowings, the construction of use space yarn between perineurium, it is ensured that
Dialyzate can flow between two films, more fully contact so that dialysis membrane has with dialyzate, improve blood depuration efficiency.Ultra micro
Effective membrane area of type dialyzer is 0.02 ㎡, and blood chamber vol is 1.4ml, and lesser blood chamber vol ensure that meiofauna blood
The operability and safety of external liquid circulation, the research suitable for the experiment of clinical meiofauna.The dialyzer of this programme is whole
It is made 100,000 grades of cleaning shops, using electron beam sterilization, does not influence to reach sterilizing purpose under the premise of material property, having can
Sterilizing is reduced on dialyzer influence to reach dosage more accurately, to greatest extent, and properties of product are more excellent after ensure that sterilizing, and nothing
Sterilizing residual.The manufacturing method of the micro dialysis device of this programme has in the shell of substantially tubular by multiple hollow fiber membranes
The dialysis that the gap between gap and hollow membrane between the blood pathway that chamber is formed and the inner walls and hollow fiber membrane is formed
Liquid stream road, manufacturing method is by techniques such as film insertion, sintering, injecting glue, shearing, painting sealant, performance detection, drying, encapsulation, sterilizings
Composition, product is fine, and manufacturing method is unified simple, and manufacture qualification rate is high, and process is simple, material is unified, tool is simple, cost
It is low.Shell and blood cap are formed using 3D printing technique, and postmenstruation processing guarantees that inside burr is less than 0.05mm, in order to avoid puncture film
Blood is leaked when Shu Zaocheng superminiature dialyzer use.The manufacturing method of this programme saves O-ring, reduces components, and reduction is fabricated to
This while, improves efficiency, and can ensure that and does not leak blood when good leakproofness makes clinical trial.Injecting glue process in manufacturing method
With needle cylinder injection, dosage is more accurate, and sterilization method uses electron beam sterilization technology, and sterilization effect is more preferably.
Based on the above feature, a kind of superminiature dialyzer and its manufacturing method phase for clinical zooscopy of this programme
There is substantive distinguishing features outstanding and significant progress than existing similar design.
A kind of superminiature dialyzer and its manufacturing method for clinical zooscopy of this programme is not limited to specific reality
Content disclosed in mode is applied, the technical solution occurred in product embodiments can also mutually can include to wrap with individualism
The operating procedure contained can carry out sequence tune appropriate under the premise of not violating technical specification and principle, for optimization operation sequence
It changes, those skilled in the art also belong to the range of this programme according to the simple replacement scheme that this programme combination common knowledge is made.
Claims (2)
1. a kind of manufacturing method of the superminiature dialyzer for clinical zooscopy, it is characterized in that comprising steps of
(1) a branch of hollow-fibre membrane boundling for being mingled with space yarn with setting quantity is threaded through with the tubulose being sized
In shell, so that the identical length in tubular shell both ends is stretched out at hollow-fibre membrane boundling both ends；
(2) the hollow-fibre membrane boundling for stretching out tubular shell one end is pruned smooth, smooth hollow fibre will be pruned using flame gun
The sintering of film boundling one end is tieed up, sets Technological cover A in the sintered one end upper cover of hollow-fibre membrane boundling；
It (3) will be excessive in gap with tubular shell in conjunction with from Technological cover A until AB glue in AB glue injection technology lid A using syringe
Stop injection out, is centrifuged solidification after the gas in Technological cover A in AB glue is discharged；
(4) the Technological cover A of prominent tubular shell one end is cut off using cutter machine, check flatness, the surface quality of section,
The section upper cover completed the process sets blood cap；
(5) the hollow-fibre membrane boundling for stretching out the tubular shell other end is pruned smooth, will be pruned using flame gun smooth hollow
The sintering of the tunica fibrosa boundling other end, sets Technological cover B in the sintered other end upper cover of hollow-fibre membrane boundling；
It (6) will be excessive in gap with tubular shell in conjunction with from Technological cover B until AB glue in AB glue injection technology lid B using syringe
Stop injection out, is centrifuged solidification after the gas in Technological cover B in AB glue is discharged；
(7) the Technological cover B of the prominent tubular shell other end is cut off using cutter machine, checks flatness, the surface quality of section,
Blood cap is set in the section upper cover completed the process；
(8) it is coated with sealing seccotine in the seam crossing of the seam crossing of tubular shell, tubular shell and blood cap connection and is formed to seal and glues
It connects, obtains dialyzer finished product.
2. the manufacturing method of the superminiature dialyzer according to claim 1 for clinical zooscopy, it is characterized in that institute
Stating manufacturing method further includes subsequent step:
(9) dialyzer finished product is subjected to water leak detection, screens out substandard product, obtain qualified dialyzer product；
(10) qualified dialyzer product is put into removal moisture drying in micro-wave oven, packs encapsulation after cooling；
(11) the qualified dialyzer product after removal moisture drying is subjected to sterilization treatment.
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| CN112826998B (en) * | 2020-12-24 | 2023-03-10 | 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 |
| CN117504026B (en) * | 2023-12-25 | 2024-05-07 | 天津大学 | Oxygenator assembly for extracorporeal membrane oxygenation |
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| US5725949A (en) * | 1995-03-11 | 1998-03-10 | Akzo Nobel Nv | Hollow-fiber bundle and mass-transfer and/or heat exchanger |
| CN1158273A (en) * | 1995-06-30 | 1997-09-03 | 东丽株式会社 | Polysulfone hollow fiber semipermeable membrane |
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|---|---|
| CN106039445A (en) | 2016-10-26 |
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