CN202961323U - Hollow fiber membrane-type medical apparatus and head forming same - Google Patents
Hollow fiber membrane-type medical apparatus and head forming same Download PDFInfo
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- CN202961323U CN202961323U CN 201220235054 CN201220235054U CN202961323U CN 202961323 U CN202961323 U CN 202961323U CN 201220235054 CN201220235054 CN 201220235054 CN 201220235054 U CN201220235054 U CN 201220235054U CN 202961323 U CN202961323 U CN 202961323U
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Abstract
The utility model provides a hollow fiber membrane-type medical apparatus which has a head shape capable of both reducing the priming volume and improving the blood distribution, and the head. The hollow fiber membrane-type medical apparatus comprises a barrel-shaped container (3), a hollow fiber membrane bundle (5), an encapsulating resin filling part (7), the head (10) and a mouth (9), wherein the section area when the inner space (A) of the head (10) is sectioned in the direction orthogonal to an axis (CS) of the barrel-shaped container (3) is supposed to be the section area of the head, the head (10) is supposed to have a height (h), which makes the volume of each unit of the section area of the head (10) be less than 1.0*10<-2> of that of a hollow fiber membrane (4), and the pressure loss on the head (10) is supposed to be 1.5-7.0% of that on the hollow fiber membrane (4), so that during axial section observation, a side surface (S2) for sectioning the inner space (A) of the head (10) is an inclined surface inclining outwards from the edge of an opposite surface S1, and inclines for 15-70 degrees relative to an end surface (4c) of the hollow fiber membrane.
Description
Technical field
This utility model relates to the hollow fiber membrane-type medical device and forms the head of this hollow fiber membrane-type medical device.
Background technology
Many blood purification therapies of having utilized Hollow Fiber Membrane Separation Technology such as hemodialysis, blood filtration, blood filtration dialysis have been designed with.These blood purification therapies are not only applicable to chronic renal failure person, are applicable to acute renal failure person, congestion DHF patient etc. yet, in recent years, are widely used in urgent rescue, ICU etc. yet.
Hollow fiber film assembly has: cylindrical container; Hollow fiber membrane bundle, its longitudinally along this cylindrical container fills in this cylindrical container, and the both ends of described cylindrical container are fixed at both ends.In addition, have perfusion potting resin section, its two ends at described cylindrical container are embedded and are fixed described hollow fiber membrane bundle.In addition, have: head (collector, ヘ Star ダ mono-), its both ends of the surface with described hollow-fibre membrane are relative and be arranged on the both ends of described cylindrical container, have the ozzle (ノ ズ Le) of the gateway that forms fluid; Oral area, the gateway that it is arranged on the side surface part of described cylindrical container and forms fluid,
The ozzle that is arranged on the head on hollow fiber membrane bundle is along axially, and the axis of stream is also by the center of hollow fiber membrane bundle.Be known that usually, because liquid flows along the zone of resistance minimum, thereby, in head, liquid can not spread all over peripheral part, the bias current of concurrent hemopoietic liquid and delay smoothly.
For example, in patent documentation 1, disclose a kind of resistance that utilizes the angle of the taper that improves head and reduce in head and made liquid spread all over the method for the peripheral part in head.But in the method, it is large that the capacity in head becomes, result is brought larger burden to the patient.
For example, in patent documentation 2, disclose a kind of utilization and dwindled the method that the area of root of the ozzle of head inside reduces the generation of bias current in head and delay.In addition, in patent documentation 3, disclose a kind of utilization and made the inner attenuation of head and the flat method that reduces the generation of the interior bias current of head and delay.But, in reference document 2 and the described method of reference document 3, the resistance in head becomes too high, liquid can not successfully spread all over the peripheral part of head, and blood is stasis in head, and result is the distributivity variation.
The prior art document
Patent documentation
Patent document 1: Japanese kokai publication hei 04-305229 communique
Patent document 2: Japanese kokai publication hei 09-108338 communique
Patent document 3: No. 2554958 communique of Japan Patent
Utility model problem to be solved
For the bias current of anti-Hemostatic Oral Liquid, that is, and in order to improve distributivity, usually, as long as the interior pressure loss of head is descended with respect to the Resistance Value (pressure loss) of hollow-fibre membrane side.In order to reduce the pressure loss in head, as long as the space in enlarged head, result is that the head that volume is larger is favourable.But, at volume, in larger head, exist priming volume (プ ラ イ ミ Application グ ボ リ ユ mono-system) to increase, inject in advance processing time and unit price and rise, be unfavorable for operating such problem.On the contrary, in the situation that adopt the head that volume is less in order to reduce priming volume, the Resistance Value in head rises, and result causes the distributivity variation of blood.
The utility model content
This utility model be take and addressed the above problem as purpose, and its purpose is to provide a kind of hollow fiber membrane-type medical device of nose shape of the raising that solves distributivity above-mentioned two contrary problems, that have the minimizing that can take into account priming volume and blood.
The invention is artificial to be addressed the above problem, and through wholwe-hearted research repeatedly, has found for making the optimized condition of above-mentioned nose shape, and has expected this utility model.
That is, this utility model is a kind of hollow fiber membrane-type medical device, and it comprises: cylindrical container; Hollow fiber membrane bundle, its longitudinally along this cylindrical container fills in this cylindrical container, and the both ends of cylindrical container are fixed at both ends; Perfusion potting resin section, its inboard at the both ends of cylindrical container surrounds the both ends of hollow fiber membrane bundle, and the both ends of hollow fiber membrane bundle are buried underground and fixed; Head, it is separately positioned on the both ends of cylindrical container, and, there is end face with hollow-fibre membrane relative and form the ozzle of the gateway of fluid; And oral area, the gateway that it is arranged on the side surface part of cylindrical container and forms fluid, wherein, when the sectional area in situation about will the inner space of head be dissectd along the direction of the orthogonal axe with cylindrical container is assumed to the sectional area of head, head have the height h, this height h make the volume of the per unit sectional area of head be hollow-fibre membrane volume 1.0 * 10
-2below, and the pressure loss expended on head reaches 1.5%～7.0% with respect to the pressure loss expended on hollow-fibre membrane, the opposite face that the inner space of head is faced mutually by the end face with hollow-fibre membrane forms with the side zoning of the edge that surrounds this opposite face, when the cross-section of utilizing along the direction of axis, side is the inclined plane that the edge from opposite face tilts toward the outer side, with respect to 15 °～70 ° of the end slopes of hollow-fibre membrane.The pressure loss preferably expended on head is 1.9%～6.9% with respect to the pressure loss expended on hollow-fibre membrane, more preferably reaches 2.0%～6.0%.In addition, preferably, with respect to the end face of hollow-fibre membrane, the angle of inclination of side is 30 °～60 °.
And, when the radius of the internal diameter by head is made as a, the height of head that will central part from the head to the direction of the orthogonal axe with cylindrical container, have left the position of a/3 is made as h
1, will be from the head central part the height of head from the position of 2a/3 to the direction of the orthogonal axe with cylindrical container that left be made as h
2the time, the height h that comparatively it is desirable to head meets following relation: 0.9～1.0h
1=h
2, or, h
1=0.9～1.0h
2.
And, comparatively it is desirable to, ozzle axis along cylindrical container on the central part of head configures, and the radius of curvature of the root of ozzle is below 3mm.Now, the preferred curvature radius is below 2.5mm, and more preferably radius of curvature is below 2.0mm.
And, comparatively it is desirable to, hollow fiber membrane bundle is 55%～70% with respect to the pack completeness of the volume of the inside of cylindrical container.
And this utility model is a kind of for forming the head of above-mentioned hollow fiber membrane-type medical device.And more particularly, the height of the inner space of described head is below 2.5mm, and the circumference of the inner space of described head has the oblique structure of 15 °～70 °.Now, preferably the height of the inner space of head is below 2.0mm respectively, and the angle of inclination of the circumference of the inner space of head is 30 °～60 °.
The effect of utility model
Adopt this utility model, can make the height optimization of head, result is the minimizing that can take into account priming volume and the raising of the distributivity of the interior blood of head.
The accompanying drawing explanation
Fig. 1 means the longitudinal section of summary of the hollow fiber membrane-type medical device of embodiment of the present utility model.
Fig. 2 be the II-II of Fig. 1 to looking sectional elevation, the cross section of the inner space on the basis while showing especially as the sectional area that calculates head.
Fig. 3 is the cutaway view that the head Watch with magnifier is shown.
Fig. 4 is the cutaway view that the structure to the head shown in Fig. 3 means more in detail.
Fig. 5 means the axonometric chart of the head shown in Fig. 4.
Fig. 6 amplifies the cutaway view of expression to the head of other embodiments.
Fig. 7 means the axonometric chart of the head shown in Fig. 6.
Fig. 8 means the curve chart that the desirable holdup time of the fluid in head distributes.
Fig. 9 means the curve chart that the holdup time of the blood filter of embodiment 1 distributes.
Figure 10 means the curve chart that the holdup time of the blood filter of embodiment 2 distributes.
Figure 11 means the curve chart that the holdup time of the blood filter of embodiment 3 distributes.
Figure 12 means the curve chart that the holdup time of the blood filter of embodiment 4 distributes.
Figure 13 means the curve chart that the holdup time of the blood filter of embodiment 5 distributes.
Figure 14 means the curve chart that the holdup time of the blood filter of comparative example 1 distributes.
Figure 15 means the curve chart that the holdup time of the blood filter of comparative example 2 distributes.
Figure 16 means the curve chart that the holdup time of the blood filter of comparative example 3 distributes.
The specific embodiment
Below, describe embodiment of the present utility model in detail with reference to accompanying drawing.In addition, this utility model is not subject to the restriction of the embodiment of following explanation.In addition, this utility model is not limited to following record, can in the scope of its purport, with various distortion, implement.
the hollow fiber membrane-type medical device
As shown in Figure 1, the hollow fiber membrane-type medical device 1 of present embodiment has: cylindrical container 3, and it is for roughly cylindric; The bundle of hollow-fibre membrane 4 (below, be called " hollow fiber membrane bundle ") 5, its filling of longitudinally along cylindrical container 3, both ends 5a, 5b are fixed in both ends 3a, the 3b of cylindrical container 3; The perfusion 7(of potting resin section Port Star テ イ Application グ Trees fat section), the inboard of its both ends at cylindrical container 3 3a, 3b surrounds both ends 5a, the 5b of hollow fiber membrane bundle 5, and, bury underground and fixedly both ends 5a, the 5b of hollow fiber membrane bundle 5.
And the side surface part 3c of cylindrical container 3 is provided with the oral area 9 of the gateway that forms fluid, on two end 3a, 3b of cylindrical container 3, is separately installed with head 10.
In the present embodiment, because the head 10 of installing on two end 3a, 3b of cylindrical container 3 respectively consists of identical structure, thereby, take the end of the top shown in one-sided end 3a(Fig. 1) head 10 describe as representative.
As shown in Fig. 1 and Fig. 3～Fig. 5, head 10 is cap shape members that the mode faced mutually with (top shown in Fig. 1) end face 4c with hollow-fibre membrane 4 configures the circle formed.Head 10 has: the cap 10a of circular, and it is for the opening of the one-sided end 3a that covers cylindrical container 3; Fixed part 10b, its periphery along cap 10a is set as cylindric, and external and be fixed in cylindrical container 3 with the one-sided end 3a of cylindrical container 3.
Then, each key element of hollow fiber membrane-type medical device 1 is illustrated in greater detail, and the manufacture method of explanation hollow fiber membrane-type medical device 1.
Shape, size, division characteristic (minute picture characteristic) for the hollow-fibre membrane 4 of present embodiment, do not limit especially, can suitably select according to application target.
Material as hollow-fibre membrane 4, for example, enumerate cellulose family macromolecule, polysulfones macromolecule, polyacrylonitrile family macromolecule, polymethyl methacrylate family macromolecule, the polyethylene kind macromolecule that comprises ethylene-vinyl alcohol copolymer, polyamide-based macromolecule, polyesters macromolecule, TPO macromolecule etc.
Can utilize known technology in the past to manufacture hollow-fibre membrane 4
And, in the situation that hydrophobic polymer is used for to the base material of hollow-fibre membrane 4, in order to give the film hydrophilic, usually, mixes hydrophilic macromolecule and carry out masking.
As hydrophilic macromolecule, for example, enumerate polyvinyl pyrrolidone (PVP), Polyethylene Glycol, polyvinyl alcohol, polypropylene glycol etc.
From the effect of hydrophiling, the aspect of safety, consider, particularly preferably polyvinyl pyrrolidone, still be not particularly limited to this.
At first, the macromolecular material that base material is used and hydrophilic macromolecule are dissolved in general solvent, prepare spinning solution.
As this general solvent, in the situation that hydrophilic macromolecule is PVP, for example, enumerate solvent that dimethyl acetylamide (below, be called DMAC), dimethyl sulfoxide, METHYLPYRROLIDONE, dimethyl formamide, sulfolane, diox equal solvent or two or more above-mentioned solvent form etc.In order to control the aperture of target hollow-fibre membrane 4, also can in spinning solution, add the additives such as water.
When the masking of hollow-fibre membrane 4, use the spinning tube head (spinning head of cast (チ ユ mono-Block イ Application オ リ Off イ ス) in hole, Spinning yarn mouth gold), make from the spinning solution (stock solution) in the hole of spinning tube head with from pipe for liquid in the hollow that this spinning solution is solidified simultaneously to aerial discharge.
As liquid in hollow, can make water or take the solidification liquid that water is main body, as long as decide it to form according to the through performance of the hollow-fibre membrane 4 as purpose, wait.Usually, comparatively it is desirable to the solvent that use is used in spinning solution and the mixed solution of water.For example, use the DMAC aqueous solution etc. of 0～65 mass percent.
The spinning solution of discharging together with liquid in hollow from the spinning tube head moves through free-running operation section (sky is walked section), and import and to be arranged on take in the coagulating bath that water is main body of spinning tube head bottom, flooded and completed and solidified, process matting etc., utilize the hollow-fibre membrane coiling machine of moisture state to be batched, thereby obtain hollow fiber membrane bundle 5, afterwards, carry out dried.Perhaps, also can be after the above-mentioned matting of process, utilization is carried out drying and is obtained hollow fiber membrane bundle 5 in drying machine.
Hollow fiber membrane bundle 5 is along the longitudinally filling of cylindrical container 3, and both ends 5a, 5b are fixed in both ends 3a, the 3b of cylindrical container 3.
For example, hollow fiber membrane bundle 5 is inserted to the cylindrical container 3 of the oral area 9 with the gateway that forms fluid, be injected into both ends 5a, the 5b of hollow fiber membrane bundle 5 and take the longitudinally center of cylindrical container 3 and carry out centrifugal rotation as axle by pouring into potting resin, thereby form perfusion encapsulated layer (perfusion potting resin) 7 on the both ends of hollow fiber membrane bundle 5 5a, 5b, utilization, can be fixing by hollow fiber membrane bundle 5 to sealed at both ends.
In addition, after fixing hollow fiber membrane bundle 5, by remaining perfusion potting resin is excised, make the end face 4c opening of hollow-fibre membrane 4 and install to there is the head 10 of oral area 9, thereby can manufacture, hollow fiber membrane bundle 5 is filled in cylindrical container 3 and the hollow fiber membrane-type medical device 1 formed.
As the material of the perfusion potting resin of both ends 5a, 5b for sealed hollow fiber-film bundle 5, enumerate polyurethane resin, epoxy resin, silicones etc., still, be not particularly limited to these.
Material as cylindrical container 3 with collector 10, for example, enumerate acrylic resin, polystyrene resin, plexiglass, pet resin, nylon 6 resin, polysulfone resin, polyacrylonitrile resin, polycarbonate resin, ABS resin, SB resin etc.
Particularly because the resin of having confirmed acrylic resin, polystyrene resin, polyacrylonitrile resin, SB resin is with low cost, the versatility in the field of medical member is higher and have a higher safety, so preferably, SB resin particularly preferably, but, be not particularly limited to these.
The ozzle 11 of head 10 for example has at JIS T 3250:2005(hemodialyzer, hemodiafiltration device, blood filter and hemoconcentrator) the blood side coupling part of 4.4.3(hemodialyzer, hemodiafiltration device and blood filter) described in structure (JIS is Japanese Industrial Standards, lower with).
In addition, the B(of the inside with respect to cylindrical container 3 hollow bulb of hollow fiber membrane bundle 5, inside) the pack completeness of volume be 55%～70%.
the optimized condition of nose shape
Secondly, illustrate minimizing for taking into account priming volume and blood distributivity raising nose shape optimized condition,, illustrate for the optimum height (h) of regulation head 10 and first condition, second condition and the 3rd condition of shape.
First condition is 1.0 * 10 of the volume of the per unit sectional area of head 10 volume that is hollow-fibre membrane 4
-2below.Herein, sectional area (with reference to Fig. 2 and Fig. 3) for head 10, suppose the cross section (cross section) in situation about will the inner space A of head 10 be dissectd along the direction of the axis CS quadrature with cylindrical container 3, and the area of cross section is assumed to the sectional area of head 10.
In addition, second condition is that the pressure loss that makes to expend on head 10 reaches 1.5%～7.0% with respect to the pressure loss expended on hollow-fibre membrane 4.Preferably the pressure loss expended on head 10 in this case reaches 1.9%～6.9% with the ratio that expends the pressure loss on hollow-fibre membrane 4, and more preferably 2.0%～6.0%.
And the 3rd condition is that all side S2 of the cap 10a of head 10 are made as to inclined plane, and S2 angle of inclination, this week side is made as to 15 °～70 °.S2 angle of inclination, preferred all sides is 30 °～60 °.
Below, illustrate in greater detail the meaning, computational methods of the term in each condition etc.
the volume of the per unit sectional area of head
Utilize following formula (1) to obtain the volume (mL/cm of the per unit sectional area of head
2).
Formula (1)
(volume in the per unit cross section of head)=(capacity of head) * 2/ (sectional area of head)
(1)
the capacity of head
Can obtain according to the weight of the water injected the capacity (the first computational methods) of head in head, or, can utilize the space in head is approximately to the capacity (the second computational methods) that simple shape based on cross sectional shape is obtained head.In the first computational methods, for example, to hollow fiber membrane bundle 5 is filled in cylindrical container 3, and by head 10 be arranged on the both ends 3a of cylindrical container 3, the weight after hollow-fiber module filling water that 3b forms is measured, obtain the volume of whole hollow-fiber module, and the difference by calculating this volume and the volume of the hollow-fibre membrane 4 obtained by following formula (3) 1/2, thereby obtain the capacity of head.
In the second computational methods, for example, utilization is to for obtaining common cylinder, the formula of the volume of the frustum of a cone etc. is combined, can calculate volume (mL), this volume (mL) refers to, centered by central shaft (axis of the cylindrical container 3) CS of head 10, make in sectional view under the state on the one-sided end 3a that head 10 is arranged on to cylindrical container 3 (along the longitudinal section of the axis CS of cylindrical container 3), end face from the opposite face S1(head 10 of the cap 10a of the head 10 that is provided with ozzle 11) to the end face of hollow-fibre membrane 4 and perfusion potting resin section 7 (below, be called " polyurethane face ") space, the volume in formed space while having carried out 360 degree rotation.
(2)
the sectional area of head
The sectional area of head 10 refers to, at the internal diameter by cylindrical container 3 sides by head 10, and for example, when the internal diameter at the approaching position of the inner surface of cap 10a and polyurethane face is made as D (with reference to Fig. 2 and Fig. 3), the area (cm that the formula (2) below utilizing is obtained
2).
Formula (2)
(sectional area of head)=(D/2)
2* ∏
(3)
the volume of hollow-fibre membrane
The volume of hollow-fibre membrane 4 refers to, the internal diameter by hollow-fibre membrane 4 be made as d, by the length of hollow-fibre membrane 4 be made as L, when the number of the hollow-fibre membrane 4 in hollow fiber membrane bundle 5 is made as to N, the volume (mL) that utilizes following formula to obtain.
Formula (3)
(volume of hollow-fibre membrane)=(d/2)
2* ∏ * L * N
expend the pressure loss on head with respect to the pressure loss expended on hollow-fibre membrane
The pressure loss of utilizing following formula (4) to obtain to expend on head 10 is with respect to the ratio that expends the pressure loss on hollow-fibre membrane 4 (%).
Formula (4)
(expend the pressure loss with respect to the ratio that expends the pressure loss on hollow-fibre membrane) on head=((expending the pressure loss on head)/(expending the pressure loss on hollow-fibre membrane)) * 100
(1)
expend the pressure loss on hollow-fibre membrane
The pressure loss expended on hollow-fibre membrane 4 is obtained by following methods,, be made as d, the length of hollow-fibre membrane 4 be made as to L, the number of hollow-fibre membrane 4 is made as to N, the flow of liquid is made as to 100(mL/min at the internal diameter by hollow-fibre membrane 4), the viscosity of liquid is made as to 0.0033(Pas) time, utilize following Ha Gen-pool Xiao Ye (Ha one ゲ Application Port ア ズ イ ユ) formula (formula (5)) to obtain, its unit is kPa.
Formula (5)
(expending the pressure loss on hollow-fibre membrane)=128 * 0.0033 * (100/60/N) * L/ ∏/d
4
(2)
expend the pressure loss on head
Utilize following formula (6) to obtain the pressure loss (kPa) expended on head 10.
Formula (6)
(expending the pressure loss on head)=(expending the pressure loss on whole hollow fiber membrane-type medical device)-(expending the pressure loss on hollow-fibre membrane)
In addition, the pressure loss on whole hollow fiber membrane-type medical device of expending in formula (6) for example can be by making to be adjusted into viscosity 0.0033(Pas) the logical liquid of PVP aqueous solution difference in hollow-fiber module the time, the pressure loss on expending before and after hollow-fiber module measured and obtained, its unit is kPa.Perhaps, can be on the both ends 5a, the 5b that collector 10 are installed on to hollow fiber membrane bundle 5 and in the model formed, hollow fiber membrane bundle 5 is as having the porous plastid that expends the pressure loss on hollow fiber membrane bundle 5, with general fluid analysis software Star-CCM+ and simulate to obtain make viscosity 0.0033(Pas to expending), density 1.055(g/cm
3) the entrance of the model of liquid during with the logical liquid of flow 100 (mL/min) to the pressure loss between outlet.
the angle of inclination of all sides of the cap of head
The S2 angle of inclination, all sides of the cap 10a of head 10 is flowed into to face as take the end face 4a(of hollow-fibre membrane 4) set as the angle of benchmark.In the present embodiment, all side S2 are with the end face 4a(polyurethane face with hollow-fibre membrane 4) angle of inclination that is 45 ° tilted.Particularly, in the situation that the cross section (longitudinal section) of head 10 being dissectd with the axis CS along cylindrical container 3 is while being observed, along the straight line of the inclination of all side S2 of the cap 10a of head 10 and the end face 4c angulation of hollow-fibre membrane 4, are S2 angles of inclination, all sides.S2 angle of inclination, this week side is 15 °～70 °, is preferably 30 °～60 °.
the height of head
The height of head 10 (h) refers to, under the state on the both ends 3a, the 3b that head 10 are arranged on to cylindrical container 3, and the distance (size) of the inner surface from the polyurethane face to cap 10a (opposite face S1).In addition, comparatively it is desirable to, the height of head 10 (h) is roughly the same height in the gamut of cap 10a, and this is roughly the same not only refers to identical situation also comprise following height h
1with height h
2meet the situation of defined terms.
height h
1
Height h
1it is the internal diameter by cylindrical container 3 sides of establishing head 10, particularly, when 1/2 of the inside diameter D at the inner surface of cap 10a and the approaching position of polyurethane face is a, in the distance of the opposite face S1 of the central shaft that has left head 10 (the axis CS of cylindrical container 3) a/3 locational 10 the cap 10a from the polyurethane face to head.
height h
2
Height h
2it is the distance at the opposite face S1 of the central shaft that has left head 10 (the axis CS of cylindrical container 3) 2a/3 locational 10 the cap 10a from the polyurethane face to head.
(3) height h
1
with height h
2
condition that should be satisfied is as follows:
0.9～1.0h
1=h
2, or h
1=0.9～1.0h
2
the radius of curvature of the root of ozzle
Radius of curvature is when circular arc is assumed to a round part, as this radius of a circle, obtains.The radius of curvature of the root 11a of the ozzle 11 of present embodiment is below 3mm.Particularly, in the situation that the cross section (longitudinal section) that the axis CS with along cylindrical container 3 is dissectd head 10 is while being observed, in the inner space of head 10 A side, the radius of curvature at the position that the inner surface of ozzle 11 connects agley with the inner surface of cap 10a is the radius of curvature of the root 11a of ozzle 11, and this radius of curvature is below 3mm.Now, the preferred curvature radius is below 2.5mm, and more preferably radius of curvature is below 2.0mm.In addition, in reality, be difficult to manufacture the radius of curvature less than 0.01mm, this means and become approximate right angle.
Above, the hollow fiber membrane-type medical device 1 of employing present embodiment, carried out optimization due to the distributivity of considering blood to height h and the shape of head 10, thereby, the height h of head 10 can be suppressed as far as possible than lowland, and priming volume can be reduced.Its result, adopt this hollow fiber membrane-type medical device 1, can take into account the raising of the distributivity of the blood in the minimizing of priming volume and head 10.
In addition, head 10 is not limited to utilize threaded portion to carry out the mode that screw thread is combined with the fixing means of cylindrical container 3.As shown in Figure 6 and Figure 7, head 10A consists of cap 10Aa and fixed part 10Ab, also can utilize deposited fixed part 10Ab and the cylindrical container 3A that fixes head 10A.In the situation that this structure, depositedly guarantee sealing due to what utilize head 10A and cylindrical container 3A, thereby, can be not between the periphery of the end face of the cap 10a side of perfusion potting resin section 7 and cap 10a, be provided for guaranteeing the encapsulant 13 of the ring-type of sealing yet.
Embodiment
Below, enumerate specific embodiment (blood filter) and the comparative example that compares with it describes, still, this utility model is not limited to following embodiment.
About evaluation test
The mode that the viscosity of usining is 3.3mPas has been dissolved the aqueous solution of Kollidon 90 (manufacturing with light society) as pond (プ ー Le), at room temperature, with flow, 100mL/min leads to liquid.At the blood filter nearside, moment is injected the red and black that dilution is 100 times (being difficult for sticking with paste industrial society manufactures) 2.5mL, by each 5mL, the liquid of discharging from blood filter is sampled.Absorbance to the 485nm place of the test liquid that obtains is measured, and the holdup time by blood filter distributes and maps to the red and black.If be not detained and bias current, depict the waveform shown in Fig. 8 as.
Insert in cylindrical containers by 6300 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 0.7m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 1).
In embodiment 1, the capacity by the head by installed is made as 1.8mL, the sectional area of head is made as to 9.0cm
2, the volume of hollow-fibre membrane (below, be called " doughnut capacity ") is made as to 44mL, thereby make the volume of the per unit sectional area of head reach 9.1 * 10 of doughnut capacity
-3.In addition, will expend the pressure loss on hollow-fibre membrane is made as 2.41kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 2.48kPa, the pressure loss that will expend on head is made as 2.9% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=1.8mm, h
2=1.8mm, the angle of inclination of all sides is 45 °.And the radius of curvature of the root of ozzle is 1.2mm.Use this blood filter 1, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in Figure 9, the holdup time of curve chart distributes and approaches desirable curve, and blood is mobile in blood filter 1, and bias current, delay can not occur.
Insert in cylindrical containers by 9100 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.0m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 2).
In embodiment 2, the capacity by the head by installed is made as 2.5mL, the sectional area of head is made as to 12.9cm
2, the doughnut capacity is made as to 63mL, thereby make 6.2 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-3.In addition, will expend the pressure loss on hollow-fibre membrane is made as 1.67kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 1.73kPa, the pressure loss that will expend on head is made as 3.6% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=1.8mm, h
2=1.8mm, the angle of inclination of all sides is 45 °.And the radius of curvature of the root of ozzle is 1.2mm.Use this blood filter 2, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 10, the holdup time of curve chart distributes and approaches desirable curve, and blood is mobile in blood filter, and bias current, delay can not occur.
Insert in cylindrical containers by 9100 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.0m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 3).
In embodiment 3, the capacity by the head by installed is made as 1.2mL, the sectional area of head is made as to 12.9cm
2, the doughnut capacity is made as to 63mL, thereby make 3.0 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-3.In addition, will expend the pressure loss on hollow-fibre membrane is made as 1.67kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 1.77kPa, the pressure loss that will expend on head is made as 6.0% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=0.7mm, h
2=0.7mm, the angle of inclination of all sides is 30 °.And the radius of curvature of the root of ozzle is 1.2mm.Use this blood filter 3, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 11, the holdup time of curve chart distributes and approaches desirable curve, and blood is mobile in blood filter, and bias current, delay can not occur.
embodiment 4
Insert in cylindrical containers by 8200 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.0m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 4).
In embodiment 4, the capacity by the head by installed is made as 3.1mL, the sectional area of head is made as to 10.8cm
2, the doughnut capacity is made as to 55mL, thereby make 1.0 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-2.In addition, will expend the pressure loss on hollow-fibre membrane is made as 3.67kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 3.74kPa, the pressure loss that will expend on head is made as 1.9% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=2.7mm, h
2=2.7mm, the angle of inclination of all sides is 60 °.And the radius of curvature of the root of ozzle is 2.5mm.Use this blood filter 4, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 12, the holdup time of curve chart distributes and approaches desirable curve, and blood is mobile in blood filter, and bias current, delay can not occur.
Insert in cylindrical containers by 11700 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.3m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 5).
In embodiment 5, the capacity by the head by installed is made as 2.7mL, the sectional area of head is made as to 16.6cm
2, the doughnut capacity is made as to 81mL, thereby make 4 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-3.In addition, will expend the pressure loss on hollow-fibre membrane is made as 1.30kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 1.39kPa, the pressure loss that will expend on head is made as 6.9% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=1.7mm, h
2=1.7mm, the angle of inclination of all sides is 45 °.And the radius of curvature of the root of ozzle is 0.5mm.Use this blood filter 5, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 13, the holdup time of curve chart distributes and approaches desirable curve, and blood is mobile in blood filter, and bias current, delay can not occur.
comparative example 1
Insert in cylindrical containers by 6300 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 0.7m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 6).
In comparative example 1, the capacity by the head by installed is made as 3.6mL, the sectional area of head is made as to 9.0cm
2, the doughnut capacity is made as to 44mL, thereby make 1.8 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-2.In addition, will expend the pressure loss on hollow-fibre membrane is made as 2.41kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 2.47kPa, the pressure loss that will expend on head is made as 2.5% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=3.7mm, h
2=3.7mm, the angle of inclination of all sides is 60 °.And the radius of curvature of the root of ozzle is 3.0mm.Use this blood filter 6, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 14, the holdup time of curve chart distributes different from desirable curve, observes the division of crest, and bias current, delay have occurred.
comparative example 2
Insert in cylindrical containers by 9100 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.0m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 7).
In comparative example 2, the capacity by the head by installed is made as 5.1mL, the sectional area of head is made as to 12.9cm
2, the doughnut capacity is made as to 63mL, thereby make 1.3 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-2.In addition, will expend the pressure loss on hollow-fibre membrane is made as 1.67kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 1.72kPa, the pressure loss that will expend on head is made as 3.0% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=3.7mm, h
2=3.7mm, the angle of inclination of all sides is 60 °.And the radius of curvature of the root of ozzle is 3.0mm.Use this blood filter 7, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 15, the holdup time of curve chart distributes different from desirable curve, observes the division of crest, and bias current, delay have occurred.
comparative example 3
Insert in cylindrical containers by 9100 hollow-fibre membranes and carry out embedding processing, molding the effective film area be 1.0m
2assembly.The head of following specification is installed at the both ends of cylindrical container, is utilized Y line (25kGy) to carry out irradiation-sterilize, thereby obtained blood filter (blood filter 8).
In comparative example 3, the capacity by the head by installed is made as 0.7mL, the sectional area of head is made as to 12.9cm
2, the doughnut capacity is made as to 63mL, thereby make 1.7 * 10 of volume that the volume of the per unit sectional area of head is hollow-fibre membrane
-3.In addition, will expend the pressure loss on hollow-fibre membrane is made as 1.67kPa, will expends that the pressure loss on whole hollow fiber membrane-type medical device is made as 1.81kPa, the pressure loss that will expend on head is made as 8.4% with respect to the ratio that expends the pressure loss on hollow-fibre membrane.
Now, the height in head is h
1=0.3mm, h
2=0.3mm, the angle of inclination of all sides is 90 °.And the radius of curvature of the root of ozzle is 1.2mm.Use this blood filter 8, the above-mentioned holdup time is distributed and estimates.Its result learns, as shown in figure 16, the holdup time of curve chart distributes different from desirable curve, observes the division of crest, and bias current, delay have occurred.
In addition, in table 1, for embodiment 1～5 and comparative example 1～3, concentrate and show following key element, that is, with respect to the volume of the per unit sectional area of the head of doughnut capacity, expend the pressure loss on head with respect to the ratio that expends the pressure loss on hollow-fibre membrane, radius of curvature, and the angle of inclination of all sides.
Table one
utilizability on industry
Hollow fiber membrane-type medical device of the present utility model can be widely used in various medical devices.For example, can enumerate hemodialyzer, the hemodiafiltration device, blood filter, the maintenance hemodialysis filter, the persistence blood filter, plasma separator, plasma fraction fraction device (minute picture device), the plasma fraction adsorber, the virus removal device, the viruses adsorption device, hemoconcentrator, the plasma extraction device, the ascites filter, ascites concentrator etc., and can utilize and to there is hollow-fibre membrane, utilized filtering feature, select in the various medical devices of characterization of adsorption (containing the characteristic that will be fixed in hollow-fibre membrane with the interactional part of adsorbed material and form).
description of reference numerals
1 ... the hollow fiber membrane-type medical device, 3 ... cylindrical container, 3a, 3b ... the end of cylindrical container, 3c ... the side surface part of cylindrical container, 4 ... hollow-fibre membrane, 4c ... the end face of hollow-fibre membrane, 5 ... hollow fiber membrane bundle, 5a, 5b ... the end of hollow fiber membrane bundle, 7 ... perfusion potting resin section, 9 ... oral area, 10 ... head, 11 ... ozzle, 11a ... the root of ozzle, A ... the inner space of head, B ... the inside of cylindrical container, CS ... the axis of cylindrical container, h, h
1, h
2the height of head, S1 ... opposite face, S2 ... all sides.
Claims (8)
1. a hollow fiber membrane-type medical device comprises:
Cylindrical container;
Hollow fiber membrane bundle, its longitudinally along this cylindrical container fills in this cylindrical container, and the both ends of described cylindrical container are fixed at both ends;
Perfusion potting resin section, its inboard at the both ends of described cylindrical container surrounds the both ends of described hollow fiber membrane bundle, and, bury and be fixed with the both ends of described hollow fiber membrane bundle underground;
Head, it is separately positioned on the both ends of described cylindrical container, and, there is end face with described hollow-fibre membrane relative and form the ozzle of the gateway of fluid; With
Oral area, the gateway that it is arranged on the side surface part of described cylindrical container and forms fluid,
This hollow fiber membrane-type medical device is characterised in that,
When the sectional area of this inner space obtained in situation about will the inner space of described head be dissectd along the direction of the orthogonal axe with described cylindrical container is assumed to the sectional area of described head, described head have the height h, this height h make the volume of the per unit sectional area of described head be described hollow-fibre membrane volume 1.0 * 10
-2below, and the pressure loss expended on described head reaches 1.5%～7.0% with respect to the pressure loss expended on described hollow-fibre membrane,
The opposite face that the described inner space of described head is faced mutually by the end face with described hollow-fibre membrane forms with the side zoning of the edge that surrounds this opposite face,
When the cross-section of utilizing along the direction of described axis, described side is the inclined plane that the edge from described opposite face tilts toward the outer side, with respect to 15 °～70 ° of the end slopes of described hollow-fibre membrane.
2. hollow fiber membrane-type medical device according to claim 1, is characterized in that,
When the radius of the internal diameter by described head is made as a, the height that has left the position of a/3 to the direction of the orthogonal axe with described cylindrical container from its central part of described head is made as to h
1, the height that has left the position of 2a/3 to the direction of the orthogonal axe with described cylindrical container from its central part of described head is made as to h
2the time,
The height h of described head meets following relation:
0.9～1.0h
1=h
2, or, h
1=0.9～1.0h
2.
3. hollow fiber membrane-type medical device according to claim 1, is characterized in that,
Described ozzle is configured in the central part of described head along the axis of described cylindrical container, and the radius of curvature of the root of described ozzle is below 3mm.
4. hollow fiber membrane-type medical device according to claim 2, is characterized in that,
Described ozzle is configured in the central part of described head along the axis of described cylindrical container, and the radius of curvature of the root of described ozzle is below 3mm.
5. according to the described hollow fiber membrane-type medical device of any one in claim 1 to 4, it is characterized in that,
Described hollow fiber membrane bundle is 55%～70% with respect to the pack completeness of the volume of the inside of described cylindrical container.
6. a head, wherein, this head is the head that forms the described hollow fiber membrane-type medical device of any one in claim 1 to 4.
7. a head, wherein, this head is the head that forms hollow fiber membrane-type medical device claimed in claim 5.
8. a hollow fiber membrane-type medical device comprises:
Cylindrical container;
Hollow fiber membrane bundle, its longitudinally along this cylindrical container fills in this cylindrical container, and the both ends of described cylindrical container are fixed at both ends;
Perfusion potting resin section, its inboard at the both ends of described cylindrical container surrounds the both ends of described hollow fiber membrane bundle, and, bury and be fixed with the both ends of described hollow fiber membrane bundle underground;
Head, it is separately positioned on the both ends of described cylindrical container, and it is relative and form the ozzle of the gateway of fluid to have an end face with described hollow-fibre membrane; With
Oral area, the gateway that it is arranged on the side surface part of described cylindrical container and forms fluid,
This hollow fiber membrane-type medical device is characterised in that,
The height of the inner space of described head is below 2.5mm, and the circumference of the inner space of described head has the oblique structure of 15 °～70 °.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2011115109 | 2011-05-23 | ||
| JP2011-115109 | 2011-05-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN202961323U true CN202961323U (en) | 2013-06-05 |
Family
ID=47673913
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201220235054 Expired - Lifetime CN202961323U (en) | 2011-05-23 | 2012-05-23 | Hollow fiber membrane-type medical apparatus and head forming same |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP6231733B2 (en) |
| CN (1) | CN202961323U (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106422788A (en) * | 2015-08-06 | 2017-02-22 | 旭化成医疗株式会社 | Hollow fiber membrane module and manufacturing method thereof |
| CN108686276A (en) * | 2017-03-31 | 2018-10-23 | 旭化成医疗株式会社 | Hollow fiber membrane-type blood purifier |
| CN109481769A (en) * | 2018-12-11 | 2019-03-19 | 广东工业大学 | A kind of membrane oxygenator with biocompatible coating |
| TWI780544B (en) * | 2019-12-27 | 2022-10-11 | 日商旭化成醫療股份有限公司 | Test methods for filters |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016060209A1 (en) * | 2014-10-16 | 2016-04-21 | 旭化成メディカル株式会社 | Body fluid filtration device of hollow fiber membrane type, and method for filtrating protein solution |
| JP6480956B2 (en) * | 2015-01-07 | 2019-03-13 | 旭化成メディカル株式会社 | Filter, ascites treatment system and ascites treatment method |
| EP3278821A4 (en) * | 2015-04-03 | 2018-04-04 | Asahi Kasei Medical Co., Ltd. | Hollow fiber membrane blood purifying device |
| JP7085800B2 (en) * | 2016-03-31 | 2022-06-17 | 旭化成メディカル株式会社 | Blood purifier, blood purification kit, and blood purification system |
| WO2023013766A1 (en) * | 2021-08-06 | 2023-02-09 | ニプロ株式会社 | Method for producing hollow fiber membrane module, and hollow fiber membrane module |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2554958B2 (en) * | 1990-11-30 | 1996-11-20 | テルモ株式会社 | Blood processing equipment |
| JPH0857266A (en) * | 1994-08-24 | 1996-03-05 | Toray Ind Inc | Fluid treatment apparatus |
| JPH09108338A (en) * | 1995-10-16 | 1997-04-28 | Toray Ind Inc | Blood port and blood processing device using the same |
| JPH1080477A (en) * | 1996-09-09 | 1998-03-31 | Toray Ind Inc | Module for blood treatment |
| JP2000126286A (en) * | 1998-10-21 | 2000-05-09 | Toray Ind Inc | Blood treating device |
| CA2576859C (en) * | 2004-08-06 | 2009-10-06 | Asahi Kasei Medical Co., Ltd. | Polysulfone hemodialyzer |
-
2012
- 2012-05-15 JP JP2012111472A patent/JP6231733B2/en active Active
- 2012-05-23 CN CN 201220235054 patent/CN202961323U/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106422788A (en) * | 2015-08-06 | 2017-02-22 | 旭化成医疗株式会社 | Hollow fiber membrane module and manufacturing method thereof |
| CN106422788B (en) * | 2015-08-06 | 2019-08-13 | 旭化成医疗株式会社 | Hollow fiber film assembly and its manufacturing method |
| CN108686276A (en) * | 2017-03-31 | 2018-10-23 | 旭化成医疗株式会社 | Hollow fiber membrane-type blood purifier |
| CN109481769A (en) * | 2018-12-11 | 2019-03-19 | 广东工业大学 | A kind of membrane oxygenator with biocompatible coating |
| TWI780544B (en) * | 2019-12-27 | 2022-10-11 | 日商旭化成醫療股份有限公司 | Test methods for filters |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2013006018A (en) | 2013-01-10 |
| JP6231733B2 (en) | 2017-11-15 |
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