CN101434122A - Method for manufacturing tube-shaped container for body fluid treater - Google Patents

Method for manufacturing tube-shaped container for body fluid treater Download PDF

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Publication number
CN101434122A
CN101434122A CNA2008101673520A CN200810167352A CN101434122A CN 101434122 A CN101434122 A CN 101434122A CN A2008101673520 A CNA2008101673520 A CN A2008101673520A CN 200810167352 A CN200810167352 A CN 200810167352A CN 101434122 A CN101434122 A CN 101434122A
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body fluid
core rod
tube
face
shaped container
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CN101434122B (en
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田中刚
铃木巨太良
松田哲
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Asahi Kasei Medical Co Ltd
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Asahi Kasei Kuraray Medical Co Ltd
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Abstract

The invention provides a manufacturing method for a cylindrical container used for a body fluid processor, which refers to the manufacturing method that when manufacturing the cylindrical container used for the body fluid processor in an injecting, molding and forming way, no burr is produced on the central inner surface of the cylindrical container by a pair of die cores using an end surface contact way, and even being produced, the burr is within an acceptable range. The invention also provides the cylindrical container which is used for the body fluid processor and has high quality and practicability, and moreover, no burr is produced on the central inner surface of the cylindrical container, thus providing a hollow fiber membrane type body fluid processor that is provided with the cylindrical container. The body fluid processor adopts the method of the cylindrical container, wherein, a cylindrical forming part is formed by the die sleeve of a die formed in the injecting, molding and forming way and a pair of die cores that are inserted in the die sleeve, synthetic resin is injected into the forming part so as to form the cylindrical container used for the body fluid processor, the end surface contact position of a pair of die cores is set within the length range of one-quarter (a quarter) to the whole length of the container starting from one end, and furthermore, injecting, molding and forming is carried out between the end surfaces of the die cores when the contact position is mutually embedded.

Description

The manufacture method of tube-shaped container for body fluid treater
Technical field
The tube-shaped container for body fluid treater that the present invention relates to a kind of manufacture method of tube-shaped container for body fluid treater and adopt this method to make, and relate to a kind of hollow fibre membranous type body fluid processor with this cylindrical container.More specifically relate to the forming section that a pair of core rod in the die sleeve that a kind of utilization is inserted in the injection mould molding mould tool forms tubular, and to this forming section injection synthetic resin and the method for shaping cylindrical container.
Background technology
Promoted so a kind of extracorporal circulatory system formula blood purification therapy in recent years, promptly, go out patient's blood draw external, remove the refuse in the blood by dialysis, filtration, and remove cause of disease materials such as own antibody, immunocomplex, low density lipoprotein albumin matter by absorption, filtration, will get back in patient's body through the blood flow that purifies thereafter.For example, can enumerate haemodialysis therapy to the chronic renal failure patient, absorption therapy, (double filtration) blood plasma of own immunological diseases patient and hyperlipoidemia patient are changed therapy, the blood plasma of hepatitis are changed therapy, absorption therapy, the white blood cell of ulcerative colitis is removed therapy and to the absorption therapy of septicemia etc.
When implementing these blood purification therapies, be used for removing the urotoxic haemodialyser of blood, blood filter, the hemodiafiltration device, be used for blood is separated into the plasma separator of blood cell and blood plasma, be used for plasma fraction is separated into the cascadeflow of high molecular weight components and low molecular weight compositions, the particular proteins that is used for the adsorbed plasma composition, lipid, the plasma fraction absorber of endotoxin (endotoxin) and cell factor (cytokine) etc., and the body fluid processors such as leukocytic white blood cell remover that are used for removing blood.
In the body fluid processor, will be used for being filled into the inside of cylindrical container from the parting material that body fluid is removed the purpose composition, for example as shown in Figure 1, install at the both ends of cylindrical container 1 and to be provided with the seal cover 6,8 that is used to make the lid side nozzle 5,7 that body fluid comes in and goes out.In addition, consider, preferably make the body fluid processor whole light and compact for this point easy to use in the treatment.And also requirement can obtain with low cost.On the other hand, as industrial water treatment filter, can not need design high pressure resistant, high flow capacity.On those grounds, tube-shaped container for body fluid treater 1 can be to be thin-walled pressure vessel about the about 1mm~3mm of thickness by the synthetic resin injection molding forming.
When making tube-shaped container for body fluid treater 1, utilize the die sleeve of injection mould molding mould tool and be inserted in the forming section that a pair of core rod in the die sleeve forms tubular, and to this forming section injection synthetic resin liquid cylindrical container 1 that is shaped.At this moment, usually the contact position of the end face of a pair of core rod is defined in middle position (for example patent documentation 1) on the length direction of forming section.This be because, when cylindrical container 1 length in the thin-walled pressure vessel as the body fluid processor is the 15cm~30cm left and right sides, if the displacement of core rod is not controlled to be the shortest, then be subjected to easily core rod drawing resistance effect and make that container deforms, breakage.Thereby, used a pair of core rod of end face contact but not the core rod of a formula.And then the contact position between the end face of regulation core rod is positioned at the central portion of the length direction of forming section.Can make like this that cylindrical container 1 does not deform, breakage, and make the mould miniaturization, therefore also can make the injection molding machine miniaturization.
But, in the method, be subjected to sometimes injecting resin flowing pressure effect and push core rod to a direction, central axis is moved, or core rod vibrates in the gap of itself and die sleeve.
The core rod that is inserted in the die sleeve is to be cylindraceous rectangular, and the end of an opposite side with the end face contact position is in by the state of supporting (fixing) firmly such as the flange part of its outer end.But the front end that forms the end face contact position becomes free end (moving about), and the rectangular butt mutually that moves about between end, thereby is difficult to supporting mutually and remains the posture of linearity, and is in the state that is easy to generate vibration.In addition, because the front end of core rod becomes free end, therefore more near near the front end, the displacement of the central axis of core rod, amplitude are just big more.Therefore, according to situations such as the injection speed of resin, viscosity, injection phases, near the central authorities on the length direction of cylindrical container, be near the contact position of end face of core rod, the wall thickness of the cylindrical container inequality that may become.Though the wall unevenness of this degree can be ignored, in the thin-walled pressure vessel as tube-shaped container for body fluid treater, there is room for improvement aspect the uniformity that improves vessel strength in having the cylindrical container of abundant wall thickness.
In addition, when the effect core rod of the injection pressure of the synthetic resin liquid when being subjected to injection molding forming is pushed to a direction, or vibrate, and when making the central axis of the core rod of the mutual butt of end face that skew take place, make the mould part (bearing surface between a pair of core rod) of contact position produce the gap.When synthetic resin liquid flows in this gap and when being cured, can produce burr on the central inner surface of tube-shaped container for body fluid treater.Contain various parting materials in the inside of body fluid processor, but these parting materials being the condensate of porous plastid or superfine fibre, structurally is not very firm material.For example, in the harder adsorption material particle in parting material, particle and burr come in contact and may cause atomic generation.In addition, in soft hollow-fiber film, make film surface damaged because of coming in contact, even also may cause the generation of aperture (pin hole) with burr.Even in parting material, hollow-fiber film produces aperture and also can directly cause blood to spill, and therefore, when particularly parting material was hollow-fiber film, fundamentally the possibility of inhibition generation burr was significant.
Therefore, make in the method for tube-shaped container for body fluid treater, studied the method (for example patent documentation 2) that suppresses to produce on the inner surface of container burr at a pair of core rod of use side face contact type.In this technology, at first, consider to be positioned at a pair of core rod divisional plane, be that the pore (air vent) of contact position of the end face of a pair of core rod is the main cause that produces burr.The size of pore is relevant with the generation of burr, this is on the books at for example non-patent literature 1: the maximum pore size as " burr is created in below the allowable limit " is 10 μ m~20 μ m when using propylene, polyethylene, and is 20 μ m~30 μ m when using polystyrene, acrylonitrile, Merlon.Therefore, when injection molding forming, consider to the generation that suppresses burr or it is minimized, need make the big or small minimum also below above-mentioned numerical value of pore (gap of mould).
Yet, in patent documentation 2 described technology, do not dwindle pore, but adopted the mould that is not provided with pore at the divisional plane of core rod from cover to cover.But this technology adopts the contact position with the end face of a pair of core rod to be defined in the mode of the central authorities on the length direction of forming section, therefore, can need not to consider the problems because of moving appears in core rod, vibration takes place.Yet,, also can core rod be pushed, or produce vibration, thereby still may produce bigger burr at the central inner surface of cylindrical container because of the effect of the flowing pressure of injecting resin even without pore.
Like this, make in the method for tube-shaped container for body fluid treater at a pair of core rod of use side face contact type, also potential near contact position the hidden danger aspect the quality of inequality, the big burr of generation container wall thickness.Present above-mentioned hidden danger does not display as yet especially as problem, but when for example wanting to improve injection speed and significantly improving productivity ratio, might problem be displayed yet.Therefore, when making tube-shaped container for body fluid treater, wish thoroughly to eliminate the hidden danger that the quality aspect exists as the new starting point.
Patent documentation 1: TOHKEMY 2003-265934 communique
Patent documentation 2: TOHKEMY 2005-46727 communique
Non-patent literature 1: " injection molding is moulded die design "-author: Fukushima has one; Nikkan Kogyo Shimbun issued on November 18th, 2002, p128
Summary of the invention
Problem of the present invention provides a kind of when making tube-shaped container for body fluid treater by injection molding forming, even use a pair of core rod of contact also can not produce burr at the central inner surface of cylindrical container, even perhaps produce burr, burr produces also such manufacture method in permissible range of degree.In addition, problem of the present invention also provides a kind of high-quality and practical tube-shaped container for body fluid treater that does not have burr at central inner surface.
The inventor furthers investigate for addressing the above problem repeatedly.It found that the importance of contact position in following manufacture method of the end face of a pair of core rod: utilizes the die sleeve of injection mould molding mould tool and is inserted in the forming section that a pair of core rod in this die sleeve forms tubular, and to this forming section injection synthetic resin and be configured as tube-shaped container for body fluid treater.That is, found this contact position is set in the importance of the centre on the length direction of unlike in the past, being located at forming section near a side end place.And then find, by being under the chimeric mutually state, the end face of core rod carries out injection molding forming, can suppress to produce big burr reliably, finally like this finished the present invention.That is, the present invention comprises following content:
(1) a kind of manufacture method of tube-shaped container for body fluid treater, utilize the die sleeve of injection mould molding mould tool and be inserted in the forming section that a pair of core rod in this die sleeve forms tubular, and inject synthetic resin and the manufacturing tube-shaped container for body fluid treater that is shaped to this forming section, it is characterized in that, the contact position of above-mentioned a pair of core rod end face is set in the length range of the quartering from container one end (1/4th) in the total length of above-mentioned forming section, and, at this contact position the end face of above-mentioned core rod is under the chimeric mutually state and carries out injection molding forming.
(2) according to the manufacture method of above-mentioned (1) described tube-shaped container for body fluid treater, it is characterized in that, the tubular forming section two end portions in the longitudinal direction of utilizing above-mentioned die sleeve and a pair of core rod and forming has big footpath shaped portion, above-mentioned contact position is set in the shoulder that begins than this big footpath shaped portion more leans on private side.
(3) according to the manufacture method of above-mentioned (1) or (2) described tube-shaped container for body fluid treater, it is characterized in that, end face by a core rod in above-mentioned a pair of core rod is provided with recess, and protuberance is set at the end face of another core rod, make this a pair of core rod concave-convex surface ground chimeric mutually.
(4) a kind of tube-shaped container for body fluid treater, it adopts as the manufacture method of each the described tube-shaped container for body fluid treater in above-mentioned (1)~(3) and obtains.
(5) a kind of hollow fibre membranous type body fluid processor wherein, is being filled hollow-fiber film as the inside of above-mentioned (4) described cylindrical container, and the sealing lid that has as the lid side nozzle of body fluid gateway is installed at its both ends.
Manufacture method according to tube-shaped container for body fluid treater of the present invention, when a pair of core rod of use side face contact type is made tube-shaped container for body fluid treater, the contact position of the end face of a pair of core rod is set in the length range of the quartering from container one end (1/4th) on the length direction of forming section, and, make at this contact position to be between the end face of core rod mutually that chimeric state carries out injection molding forming.Like this, can suppress core rod and rock, and keep two core rods to be in the shaping posture of linearity securely, thereby the effect of the injection pressure of synthetic resin liquid also can produce the gap in the part of contact position hardly when being subjected to injection molding forming.That is, produce burr hardly in this position, even perhaps produce burr, burr generation degree also in permissible range, therefore, can obtain this cylindrical container length and how all can suppress the tube-shaped container for body fluid treater that burr produces.
When such tube-shaped container for body fluid treater is filled with the body fluid processor of separation materials such as hollow-fiber film, adsorption material particle as its inside, the parting material of internal tank can not wait and burr generation sliding-contact because of vibration, even sliding-contact perhaps takes place, the sliding-contact occurrence degree thereby makes the parting material damaged and produces aperture or produce atomic risk extremely low also in permissible range.
In addition, according to the formation of above-mentioned (2), can will be manufactured on the body fluid processor that two end portions has big footpath tube portion as the position of the best with the corresponding part of contact position.
And, according to the formation of above-mentioned (3),, also can suppress longer core rod reliably and vibrate even carry out easy to be chimericly with the structure of concave-convex surface.
And then, according to the formation of above-mentioned (4), can provide a kind of tube-shaped container for body fluid treater that suppresses to produce burr.
And,, can obtain to be filled with parting material in the inside of cylindrical container and the body fluid processor that has as the lid of the lid side nozzle of body fluid gateway is installed at its both ends according to the formation of above-mentioned (5).The central inner surface that this body fluid processor can be suppressed at cylindrical container produces burr, therefore, do not exist the parting material of being filled by burr mechanically damage may.Therefore, the present invention can provide the processor of the body fluid with very high quality.
Description of drawings
Fig. 1 is the local stereogram that is cut off of body fluid processor.
Fig. 2 is the cutaway view of the injection mould molding mould tool that uses among the present invention.
Fig. 3 is the schematic diagram to an example of top contact position of expression a pair of core rod of the present invention.
Fig. 4 is another routine schematic diagram to the top contact position of expression a pair of core rod of the present invention.
Fig. 5 is the schematic diagram to an example of top contact position of a pair of core rod of expression in the comparative example of the present invention.
Fig. 6 is another routine schematic diagram to the top contact position of a pair of core rod in the expression comparative example of the present invention.
Fig. 7 is the schematic diagram of an example again to the top contact position of a pair of core rod in the expression comparative example of the present invention.
Fig. 8 is another routine schematic diagram again to the top contact position of a pair of core rod in the expression comparative example of the present invention.
Fig. 9 is the schematic diagram of the damage test (harsh test) of expression parting material.
The specific embodiment
Body fluid processor described in the present invention is, fills the parting material that is used for removing from body fluid the purpose composition in the inside of cylindrical container, and the device that has as the sealing lid of the lid side nozzle of body fluid gateway is installed at its both ends.Such structure and shape are comparatively common on haemodialyser, various splitter etc., it are done concrete especially qualification.
As the concrete example of body fluid processor, can enumerate haemodialyser, blood filter, hemodiafiltration device, plasma separator, cascadeflow, plasma fraction absorber and white blood cell remover etc.In addition, in recent years,, in the refining step of the Blood Preparations of usefulness of transfusing blood, biological medicine product, use the hollow-fiber film type filter to remove pathogenicity particulates such as virus mostly for the purpose of protecting from infection.Such virus is removed filter and is also had structure and the shape same with above-mentioned body fluid processor, and the solution that is used to lead to liquid also comparing class is similar to body fluid, therefore, the filter of the virus of hollow fibre membranous type removal in the present invention also can be included in the category of body fluid processor.
Parting material is dialysis and the hollow-fiber film bundle that filters usefulness, is cylindric stacked filtration and adsorbs the adhesive-bonded fabric of usefulness, porous plasmid of absorption usefulness etc.When parting material is hollow-fiber film, nonwoven, to the both ends of parting material pour into a mould processing and be fixed on the inner surface of cylindrical container; When parting material is the porous plasmid period of the day from 11 p.m. to 1 a.m, the inner surface of cylindrical container is carried out fine finishining so that particle does not flow out.
Owing to require the body fluid processor light on the whole and compact, and can obtain, therefore in cylindrical container, sealing lid, used resin material with low cost.As resin material, can enumerate acrylic resin, unmodified polystyrene resin, plexiglass, polyethylene terephthalate resin, nylon 6 resin, polysulfone resin, polyacrylonitrile resin, SB resin, polycarbonate resin etc.Wherein, the resin cost is lower, and resin material long in medical equipment field use experience, through confirming to have higher-security is acrylic resin, polystyrene resin, polyacrylonitrile resin, styrene-butadiene co-polymer resin.The hardness ratio of these resins is lower thus, therefore we can say that they are difficult to parting material is caused mechanical damage.Otherwise the hardness ratio of polycarbonate resin, polystyrene resin is higher, thereby regardless of burr height, causes the risk of mechanical injuries all can be higher slightly to parting material.
Based on the reason that improves dialytic efficiency, separation efficiency, usually whole body fluid processor is made as the drum of lengthwise, and is roughly symmetric shape at length direction.Concrete length is approximately 15cm~45cm, but then is about 15cm~30cm if deduction virus is removed the filter part.Equally, maximum gauge is approximately 5cm~20cm (if the nozzle ledge that also comprises the cylindrical container side then further increases 3cm~5cm), but deduction virus is removed the filter part and then is approximately 5cm~10cm.Thick 1mm~the 3mm that all is approximately of wall of a container.The ratio that common lid accounts for whole body fluid processor is lower, thereby tube-shaped container for body fluid treater also has above-mentioned same size.
As the body fluid processor, parting material is being filled in the process of cylindrical container inside, need parting material not to be caused mechanical damage, thus have or not burr on the inner surface of cylindrical container, burr produces degree and the container quality matters a lot.The burr that the central inner surface at tube-shaped container for body fluid treater described in the present invention produces is meant the protuberance that produces usually on the part face that is formed that die sleeve, core rod with mould connect.Usually the burr height that produces in such cylindrical container is approximately about 100 μ m~300 μ m.In various parting materials, be subjected to the burr mechanical injuries the darkest be hollow-fiber film, but the average film thickness of the hollow-fiber film that uses on the body fluid processor is about 50 μ m.Therefore, for the burr of such height, when hollow-fiber film is subjected to the effect of unusual big power and when sliding-contact or high-frequency ground taking place sliding-contact taking place, thickness portion may be subjected to not tolerable big mechanical injuries like that.Otherwise,, then be difficult to consider have the possibility that is subjected to the such mechanical injuries of tolerable not for the burr of the average film thickness height that highly is equivalent to hollow-fiber film.Therefore, in the present invention, if the height of burr is below the height 50 μ m as average film thickness, then it to be can be considered the height that can not produce problem on the container quality.More preferably below the 25 μ m.The length of burr is to cross over the part of part face that is formed sometimes, or crosses over whole.
When the tube-shaped container for body fluid treater that will produce such burr is used on the haemodialyser of hollow fibre membranous type for example, the flow situation of the vibration that causes of vibration when transferring, the dislysate when using might make the hollow-fiber film with the burr sliding-contact sustain damage.Particularly during hollow fibre membranous type body fluid processor,, hollow-fiber film is fixed on the cylindrical container, so have near the easiest vibration central portion of burr because being both ends.The height of these main causes and burr, acute angle acting in conjunction are when causing bigger damage to the film surface, though very rare but increased the risk that causes leakage because of aperture.
In the manufacturing of tube-shaped container for body fluid treater of the present invention, both are inserted in the die sleeve of injection mould molding mould tool simultaneously with the core rod of pair of cylinders shape, by making the both ends of the surface contact of core rod, utilize die sleeve and two core rods to form the forming section of tubular.Under this state, synthetic resin liquid is expelled on the forming section, and after supercooling, can be configured as tube-shaped container for body fluid treater.At this moment, the contact position of the end face of a pair of core rod is set in the length range of the quartering from container one end (1/4th) in the total length of forming section, and, make the end face of core rod chimeric mutually at this contact position, therefore, can under the effect of the injection pressure of synthetic resin liquid, make the part of contact position produce the gap hardly.
The a pair of core rod of use side face contact type when making as tube-shaped container for body fluid treater roughly the cylindrical container of symmetric form,, contacted in the centre of forming section in order to make core rod in the past, had used a pair of core rod that has equal length mutually.But, in the present invention, specialize in order to make above-mentioned manufacture method, and used length different a pair of core rod mutually.Like this, make a core rod shorter relatively, thereby the effect that the part of its end face is subjected to injection pressure under to the effect of bed knife of die sleeve side etc. also do not rock, can keep its posture securely.On the other hand, make another core rod longer relatively, thereby the effect that the part of its end face is subjected to injection pressure will be rocked.But, at the contact position tabling, long core rod is fixed on the short core rod by end face that makes long core rod and the end face of lacking core rod firmly, therefore, also can keep this posture securely.Can prevent that so whole core rod from rocking, can keep the linearly shaping posture of two core rods securely.Therefore, can obtain to have the tube-shaped container for body fluid treater of following advantage: make the part of contact position that the gap takes place under the effect of the injection pressure of synthetic resin liquid that hardly can be when injection molding forming, and how the length length of cylindrical container all can suppress the generation of burr.
Below, the present invention will be described in detail with reference to accompanying drawing, but the present invention is not limited in following accompanying drawing illustration.
Fig. 2 is the cutaway view that is used to make the injection mould molding mould tool 10 of tube-shaped container for body fluid treater 1 of the present invention.
In Fig. 2, injection mould molding mould tool 10 is that the die sleeve 11 of breakthrough part cylindraceous constitutes with the promptly short core rod 21 of a pair of core rod 21,31 in the breakthrough part that is inserted in this die sleeve 11, long core rod 31 etc. by middle body.At this, the two end portions of the breakthrough part of die sleeve 11 is formed on the core rod spigot surface 12, and the part between the core rod spigot surface 12 is formed on the outer forming face 13.At this moment, outer forming face 13 is by be shaped facial 13A and constitute at these ends facial 13B that is shaped of the central authorities of the long size between the facial 13A that is shaped of the end in short size that links to each other with core rod spigot surface 12 and big footpath.And, form to insert by the both ends of the surface of the length direction of die sleeve 11 and accept face 14, and under the state that breakthrough part exposes separable.
Be formed with being inserted on the insertion section in the breakthrough part of above-mentioned short core rod 21 and long core rod 31: can with the face that is directed to 22,32 of core rod spigot surface 12 fluid-tight engagement be directed to the internal shaping face 23,33 that face 22,32 is connected with this.At this moment, internal shaping face 23,33 is by the end in short size that is connected with the face of being directed to 22,32 and big footpath be shaped facial 23A, 33A and lay respectively at end be shaped facial 23B, the 33B of central authorities between facial 23A, the 33A that be shaped and constitute.
And, the insertion contact-making surface 25,35 of the flange part 24,34 by making the outer end that is arranged at short core rod 21 and long core rod 31 and insertion are accepted face 14 and are connected, make the facial 23A of end shaping, 33A is mutually opposed with the facial 13A of end shaping, and make shaping facial 23B, 33B of central authorities and the facial 13B of shaping of central authorities mutually opposed, thus, form the forming section 41 of tubular by the internal shaping face 23,33 of the outer forming face 13 of die sleeve 11 and short core rod 21 and long core rod 31.At this moment, in the two end portions of the length direction of forming section 41, by end the be shaped opposed partially-formed big footpath shaped portion 41A of facial 13A of facial 23A, 33A and end that is shaped.
At this, central authorities in the short core rod 21 are shaped, and to form the be shaped length of facial 33B of central authorities than long core rod 31 short for the length of facial 23B.Promptly, with the contact position A of end face 21a, the 31a of a pair of short core rod 21 and long core rod 31 be set in respect to the shaping length L on the length direction of forming section 41 in the length range S of the quartering (1/4th) of the end of short core rod 21 sides (side), and contact position A be set in the shoulder B that the big footpath of the ratio shaped portion 41A of short core rod 21 sides begins more lean on private side.
In addition, end face 21a, the contact of 31a is to be contacted by the chimeric mutually tabling of the concavity end face 21a that is provided with recess and the convex end face 31a concave-convex surface that is provided with protuberance.In Fig. 2, long core rod 31 is convex, but concavo-convex state also can be opposite chimeric state.The tabling structure is not limited to illustrated concavo-convex, gets final product so long as can bring into play the structure of same function.For example, at one end can be provided with a plurality of concavo-convexly on the face, the convex end face also can be coniform or needle-like.In addition, can also be by the mode of zigzag end face tabling contact, the way of contact of flat end face etc.
And,, be formed for synthetic resin liquid is expelled to sprue gate (cast gate) 15 in the forming section 41 at middle body (center) C of the length direction of die sleeve 11.
Below, the effect of above-mentioned embodiment is described.
Before making tube-shaped container for body fluid treater, in injection mould molding mould tool 10, be inserted in the breakthrough part of die sleeve shown in Figure 2 11 by lacking core rod 21 and long core rod 31, connect and make the insertion contact-making surface 25,35 of flange part 24,34 and insertion accept face 14, and make face of being directed to 22,32 and core rod spigot surface 12 fluid-tight engagement, and then contact with making concavity end face 21a and convex end face 31a tabling.Thus, form the forming section 41 of tubular by the internal shaping face 23,33 of the outer forming face 13 of die sleeve 11 and core rod 21,31.
Under this state, make its cooling after being expelled to synthetic resin liquid in the forming section 41 by sprue gate 15, tube-shaped container for body fluid treater 1 can be shaped.At this moment, by with end face 21a, the contact position A of 31a be set in respect to the shaping length L on the length direction of forming section 41 in the length range S of the quartering (1/4th) of the end of short core rod 21 sides, the part of contact position A produces the gap hardly under the effect of the injection pressure of synthetic resin liquid.Promptly, facial 23B is shorter because central authorities are shaped, so in connecting airtight under power, the effect to the butt bed knife of flange part 24 etc. of the face of being directed to 22, the part of the concavity end face 21a of short core rod 21 can not rocked because of the effect of injection pressure, and can keep its posture securely.
In addition, because of central authorities' effect desire that the long part that makes the convex end face 31a of long core rod 31 of facial 33B is subjected to injection pressure that is shaped is rocked, the part of convex end face 31a connects by the part with the concavity end face 21a that keeps its posture securely and is supported at this moment, can prevent and rock, can keep the shaping posture of the linearity of two central authorities shaping facial 23B, 33B thus securely.Therefore, the part of the contact position A of the injection pressure effect of the synthetic resin liquid when being subjected to injection molding forming fully (or almost) can not produce the gap, thus the length length that can produce this cylindrical container how all fully (or almost) can not produce the tube-shaped container for body fluid treater 1 of burr.
So, after injection and shaping tube-shaped container for body fluid treater 1, short core rod 21 shown in Figure 2, long core rod 31 are extracted.At this moment, corresponding to end face 21a, the extracting of the part of 31a, the automatic supply of air constitutes and prevents evacuation in tube-shaped container for body fluid treater 1.After extracting short core rod 21, long core rod 31,, can take out tube-shaped container for body fluid treater 1 as shown in Figure 1 by making die sleeve 11 somatotypes (separating) etc.At this moment, on die sleeve 11, be provided with forming section (not shown) as the vessel side nozzle 2,3 of gateways such as dislysate, filtered fluid etc., thereby, tube-shaped container for body fluid treater 1 has the big footpath 1A of tube portion, 1B in the two end portions of cylindrical portion, and on a big footpath tube 1A of portion, has vessel side nozzle 2, and on another big footpath 1B of tube portion, have vessel side nozzle 3, under this state, can carry out integrally formed.And then, can produce on the inner peripheral surface of cylindrical portion with the corresponding part 1a of contact position A on fully (or almost) do not produce the tube-shaped container for body fluid treater 1 of burr.
The for example such parting material (not shown) of hollow-fiber film bundle is filled in inside at such tube-shaped container for body fluid treater 1, the sealing lid 6 that has as the lid side nozzle 5 of body fluid gateway is installed at the one end, and at the other end sealing lid 8 with lid side nozzle 7 is installed, can be obtained the body fluid processor thus.
When the body fluid processor that will be filled with parting material continues to import to sterilization process or transfers as product, perhaps use it for and treat when arranging, even vibrate because of vibration, liquid flow make parting material, with the corresponding part 1a of contact position A also fully (or almost) can not produce burr, thereby fully the parting material that vibrated and the phenomenon of burr sliding-contact can not take place in (or almost), therefore, parting material can not be subjected to mechanical injuries.
And then the shoulder B that begins by the big footpath shaped portion 41A that contact position A is set in than short core rod 21 is more by private side, can with the corresponding part 1a of contact position A as position in the best.
Except above-mentioned embodiment, the body fluid processor etc. that the present invention can also be applied to not have the cylindrical portion of the big footpath 1A of tube portion, 1B is used for the various body fluid processors of other purpose.
In the above-described embodiment, expression is set in the mode that shoulder B that the big footpath shaped portion 41A than short core rod 21 sides begins more leans on private side with contact position A, but it also can be to be made as the mode of contact position A with the corresponding part of big footpath shaped portion 41A.
The body fluid processor that obtains according to the present invention can be enumerated haemodialyser, blood filter, hemodiafiltration device, plasma separator, cascadeflow, plasma fraction absorber, white blood cell remover etc., but wherein the haemodialyser of hollow fibre membranous type has the feature of utilizing (reuse) again abroad in the U.S., Taiwan etc.What is called is utilized and is meant, haemodialyser after the use through cleaning, regeneration handles, can be limited to same patient and can carry out several and arrive the reusable cure of tens of numbers.Therefore, for its repeated use degree, through linging (priming) operation, so compare with other body fluid processor, the frequency that parting material (hollow-fiber film) contacts with burr becomes quite high, thereby does not produce the burr particular importance that seems at the inner surface of cylindrical container 1.Tube-shaped container for body fluid treater 1 of the present invention is preferably used as especially and can carries out partly the cylindrical container 1 that the hollow fibre membranous type haemodialyser of utilization is used again from the result that complete (almost) do not produce burr.
Embodiment
Below, by embodiment action effect of the present invention is carried out further specific description, but the invention is not restricted to described embodiment.At first, various assay methods are described.
In addition, in following each embodiment 1~4 and each comparative example 1~6, the basic size of cylindrical container 1, shape are common, but the optimum condition of injection molding forming is different because of resin, and actual conditions carries out suitable setting according to every kind of resin.
[mensuration of burr height]
The tube-shaped container for body fluid treater 1 that goes out from injection molding forming downcuts the end face 21a that comprises a pair of core rod 21,31, and the contact position A of 31a, i.e. prediction will produce the container piece of the part 1a of burr in interior about 3cm * 1cm size.Container piece is fixed on the sample fixed station of contactless dimension measurement device (Nikon system, NEXIV VMR-3020), and makes the cross section of burr seem to be the mountain shape, the height of burr is measured.
[damage test of parting material]
The bigger hollow-fiber film that goes wrong when using the more weak and damaged of anti-mechanical injuries is implemented harshness test shown in Figure 9, has or not burr according to the central inner surface of cylindrical container 1, and the degree of injury that bears parting material is estimated.
The container piece of using during with the said determination burr height is fixed on the sample fixed station in inner surface side mode up.Then, the haemodialysis of 20 root polypropylene nitrile systems is listed as two layers with porous matter hollow-fiber film (internal diameter 235 μ m, thickness 35 μ m, length 5cm) with the state with the burr approximate vertical, for weight is distributed equably, the counterweight of 50g is positioned in these porous matter hollow-fiber film top lightly across the silica gel sheet of thickness 2mm.The face that is provided with of counterweight is made as 20mm * 20mm.Suppose it is haemodialysis, whole this testpieces is positioned over dipping takes out all hollow-fiber films after 4 hours in 37 ℃ the warm water again, be placed on the outer surface that microscopically is observed hollow-fiber film.
Observe the state of the hollow fibre film outer surface of each sample successively from the hollow-fiber film of damaged degree maximum, (do not observe hollow part by aperture (observing hollow part), scratch, the pit that just is obvious wire), striped (not observing the pit that is obvious wire, just the striped trace of wire), undamaged 4 stages are estimated totally.In 20 hollow-fiber films, with the evaluation of the hollow-fiber film of degree of injury maximum evaluation as this sample.
Embodiment 1
Preparation has the injection mould molding mould tool 10 of following formation, promptly, in injection mould molding mould tool 10 shown in Figure 2, with the end face 21a of a pair of core rod 21,31, the contact position A of 31a is set in the side of the shoulder B that the big footpath shaped portion 41A of whole length one end of forming section 41 begins other (in the length range S of the quartering (1/4th) of a side container end portion).In this injection mould molding mould tool 10, it is chimeric mutually in couples with the long core rod 31 that is provided with recess at end face 31a to be provided with the short core rod 21 of protuberance at end face 21a, under this state, to forming section 41 benzene injection ethylene-butadiene copolymer resins, thus the tube-shaped container for body fluid treater 1 of acquisition total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 of expression cylindrical container 1 in Fig. 3.In addition, Fig. 3 (a) is representative side section view; Fig. 3 (b) is diagrammatic side view; Fig. 3 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 only is 6.0 μ m, reaches the degree that can be observed striped on this position of hollow-fiber film.
Embodiment 2
Obtain the cylindrical container 1 of total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm except adopting polycarbonate resin to carry out injection molding forming, also use the injection mould molding mould tool 10 identical to obtain tube-shaped container for body fluid treater 1 with the foregoing description 1.
The height of the burr on the contact position A of core rod 21,31 only is 6.0 μ m, reaches the degree that can be observed striped on this position of hollow-fiber film.
Embodiment 3
Preparation has the injection mould molding mould tool 10 of following formation, promptly in injection mould molding mould tool 10 shown in Figure 2, the contact position A of the end face of a pair of core rod 21,31 is set in the length of the quartering from container one end (1/4th) of the total length of forming section 41.In this injection mould molding mould tool 10, it is chimeric mutually in couples with the long core rod 31 that is provided with protuberance at end face 31a to be provided with the short core rod 21 of recess at end face 21a, under this state, to forming section 41 benzene injection ethylene-butadiene copolymer resins, thus the tube-shaped container for body fluid treater 1 of acquisition total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 in Fig. 4 in the expression cylindrical container 1.In addition, Fig. 4 (a) is representative side section view; Fig. 4 (b) is diagrammatic side view; Fig. 4 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 only is 12.0 μ m, reaches the degree that can be observed striped on the A of this position of hollow-fiber film.
Embodiment 4
Obtain the cylindrical container 1 of total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm except adopting polycarbonate resin to carry out injection molding forming, also use the injection mould molding mould tool 10 identical to obtain tube-shaped container for body fluid treater 1 with the foregoing description 3.
The height of the burr on the contact position A of core rod 21,31 only is 22.0 μ m, reaches the abrasive degree that can be observed on the A of this position of hollow-fiber film.
Comparative example 1
Preparation has the injection mould molding mould tool 10 of following formation,, in injection mould molding mould tool 10 shown in Figure 2, the contact position A of the end face of a pair of core rod 21,31 is set in the container centre on the whole length of forming section 41 that is.In this injection mould molding mould tool 10, the core rod with equal length 21,31 that will be provided with recess at an end face 21a, is provided with protuberance at another end face 31a is chimeric mutually in couples, under this state, to forming section 41 benzene injection ethylene-butadiene copolymer resins, thus the tube-shaped container for body fluid treater 1 of acquisition total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 of expression cylindrical container 1 in Fig. 5.In addition, Fig. 5 (a) is representative side section view; Fig. 5 (b) is diagrammatic side view; Fig. 5 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 is 210.0 μ m, observes aperture on this position of hollow-fiber film.
Comparative example 2
Obtain the cylindrical container 1 of total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm except adopting acrylic resin to carry out injection molding forming, also use the injection mould molding mould tool 10 identical to obtain tube-shaped container for body fluid treater 1 with above-mentioned comparative example 1.The height of the burr on the contact position A of core rod 21,31 is 200.0 μ m, observes aperture on this position of hollow-fiber film.
Comparative example 3
Preparation has the injection mould molding mould tool 10 of following formation, promptly in injection mould molding mould tool 10 shown in Figure 2, with the end face 21a of a pair of core rod 21,31, the contact position A of 31a be set in forming section 41 total length on 1/3rd position of container one end.In this injection mould molding mould tool 10, it is chimeric mutually in couples with the long core rod 31 that is provided with protuberance at end face 31a to be provided with the short core rod 21 of recess at end face 21a, under this state, to forming section 41 injection polycarbonate resins, thus the tube-shaped container for body fluid treater 1 of acquisition total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 of expression cylindrical container 1 in Fig. 6.In addition, Fig. 6 (a) is representative side section view; Fig. 6 (b) is diagrammatic side view; Fig. 6 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 is 120.0 μ m, observes aperture on this position of hollow-fiber film.
Comparative example 4
Obtain the cylindrical container 1 of total length 280mm, external diameter (barrel) 40mm, wall thickness (barrel) 2mm except that adopting polyacrylonitrile resin to carry out injection molding forming, also use the injection mould molding mould tool 10 identical to obtain tube-shaped container for body fluid treater 1 with above-mentioned comparative example 3.
The height of the burr on the contact position A of core rod 21,31 is 140.0 μ m, observes aperture on this position of hollow-fiber film.
Comparative example 5
Be not provided with the injection mould molding mould tool 10 of the short core rod 21 of tabling structure and long core rod 31 except use is inserted with end face, the method that other adopts and the foregoing description 1 is same obtains the tube-shaped container for body fluid treater 1 of the resinous total length 280mm of SB, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 of expression cylindrical container 1 in Fig. 7.In addition, Fig. 7 (a) is representative side section view; Fig. 7 (b) is diagrammatic side view; Fig. 7 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 is 220.0 μ m, observes aperture on this position of hollow-fiber film.
Comparative example 6
Be not provided with the injection mould molding mould tool 10 of the short core rod 21 of tabling structure and long core rod 31 except use is inserted with end face, the method that other adopts and the foregoing description 1 is same obtains the tube-shaped container for body fluid treater 1 of the resinous total length 280mm of SB, external diameter (barrel) 40mm, wall thickness (barrel) 2mm.The contact position A of the core rod 21,31 in Fig. 8 in the expression cylindrical container 1.In addition, Fig. 8 (a) is representative side section view; Fig. 8 (b) is diagrammatic side view; Fig. 8 (c) is diagrammatic top view.
The height of the burr on the contact position A of core rod 21,31 is 143.0 μ m, observes aperture on this position of hollow-fiber film.
Table 1
Figure A200810167352D00221
Shown in above-mentioned table 1, confirm in the tube-shaped container for body fluid treater 1 that adopts manufacture method of the present invention to obtain, to produce the small burr (embodiment 1~4) about height 6 μ m~22 μ m.But, in above-mentioned arbitrary embodiment,, or there is the scratch phenomenon even also just be attached with the trace of burr at the outer surface of hollow-fiber film through harsh test, confirming does not have to find the poorest situation, the i.e. generation of aperture.That is, though observed small burr, the suffered mechanical injuries degree of parting material is in permissible scope.
On the other hand, used the manufacture method of the core rod 21,31 of formula in the past and in the tube-shaped container for body fluid treater 1 that obtains in employing, being formed with highly is the so big burrs (comparative example 1~6) considerably beyond the thickness of hollow-fiber film of 140 μ m, and confirms to occur the generation of aperture in the harshness test.Certainly, this supposes just that several main causes that surpass to limit act on simultaneously and the harshness test of the big mechanical injuries that cause, and does not mean that present existing cylindrical container 1 can go wrong at once.But, when will significantly improving the productivity ratio of cylindrical container 1, plan may make problem show especially out, and this exists potential needs to improve part undoubtedly.
Industrial utilizability
Utilize manufacture method of the present invention, can provide a kind of and on central inner surface, not produce Setation thorn, even or produce burr, burr produce degree also in permissible range like that Tube-shaped container for body fluid treater. So high-quality cylindrical container is suitable for well As the composition member of various body fluid processors, this body fluid processor can be very safely The blood purification therapy that is used for circulation-type. In addition, filter as virus removal Device also can be applicable in the refining step of preparation well.

Claims (5)

1. the manufacture method of a tube-shaped container for body fluid treater, it utilizes the die sleeve of injection mould molding mould tool and the forming section that a pair of core rod in this die sleeve of insertion forms tubular, to this forming section injection synthetic resin manufacturing tube-shaped container for body fluid treater that is shaped, it is characterized in that, the contact position of the end face of above-mentioned a pair of core rod is set in above-mentioned forming section total length in 1/4th length range of container one end, and, make between the end face of above-mentioned core rod to be under the chimeric mutually state and carry out injection molding forming at this contact position.
2. the manufacture method of tube-shaped container for body fluid treater according to claim 1, it is characterized in that, the forming section two end portions in the longitudinal direction of the tubular that utilizes above-mentioned die sleeve and a pair of core rod and form has big footpath shaped portion, above-mentioned contact position is set in the shoulder that begins than this big footpath shaped portion more leans on private side.
3. the manufacture method of tube-shaped container for body fluid treater according to claim 1 and 2, it is characterized in that, end face by a core rod in the middle of above-mentioned a pair of core rod is provided with recess, and the end face at another core rod is provided with protuberance, makes this a pair of core rod concave-convex surface ground chimeric mutually.
4. a tube-shaped container for body fluid treater is characterized in that, this tube-shaped container for body fluid treater adopts the manufacture method of central each the described tube-shaped container for body fluid treater of claim 1~3 to obtain.
5. a hollow fibre membranous type body fluid processor is characterized in that, fills hollow-fiber film in the inside of the described cylindrical container of claim 4, and the sealing lid is installed at its both ends, and the sealing lid has the lid side nozzle as the body fluid gateway.
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CN107073192A (en) * 2014-09-29 2017-08-18 旭化成医疗株式会社 Hollow fiber membrane type blood purifier
CN108175888A (en) * 2018-01-05 2018-06-19 苏州仝康医疗科技有限公司 Blood toxicity absorber
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CN104260282B (en) * 2014-09-18 2017-03-15 苏州君康医疗科技有限公司 A kind of mould of hemodialyzer casing
CN107073192A (en) * 2014-09-29 2017-08-18 旭化成医疗株式会社 Hollow fiber membrane type blood purifier
CN107073192B (en) * 2014-09-29 2019-08-09 旭化成医疗株式会社 Hollow fiber membrane type blood purifier
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