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WO2014050468A1 - Dispositif de traitement de sang - Google Patents

Dispositif de traitement de sang Download PDF

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Publication number
WO2014050468A1
WO2014050468A1 PCT/JP2013/073798 JP2013073798W WO2014050468A1 WO 2014050468 A1 WO2014050468 A1 WO 2014050468A1 JP 2013073798 W JP2013073798 W JP 2013073798W WO 2014050468 A1 WO2014050468 A1 WO 2014050468A1
Authority
WO
WIPO (PCT)
Prior art keywords
opening
housing
dialysate
blood
size
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2013/073798
Other languages
English (en)
Japanese (ja)
Inventor
泰弘 御幡
純 樫原
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SB Kawasumi Laboratories Inc
Original Assignee
Kawasumi Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kawasumi Laboratories Inc filed Critical Kawasumi Laboratories Inc
Priority to JP2014538329A priority Critical patent/JP6203186B2/ja
Publication of WO2014050468A1 publication Critical patent/WO2014050468A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621—Constructional aspects thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/10—Specific supply elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/16—Specific vents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2313/00—Details relating to membrane modules or apparatus
    • B01D2313/21—Specific headers, end caps

Definitions

  • the present invention relates to bleeding of a blood processing apparatus used for hemodialysis, blood filtration, hemodiafiltration, plasma separation, and the like. More specifically, the present invention relates to a dialysis solution and a hollow fiber bundle in the housing at the time of priming of the blood treatment apparatus in which the hollow fiber membrane bundle is loaded in the housing (also referred to as “casing”). This is related to the air mixed into the housing or generated air during treatment such as evacuation or dialysis, which is filled with physiological saline solution to expel the air in the housing and hollow fiber membrane bundle)
  • the present invention relates to a novel blood processing apparatus configured to easily perform an operation (air venting) for removing sucrose outside the system.
  • the present invention relates to a blood processing apparatus having a novel obstacle member formed in a housing.
  • a blood treatment device is a device that removes pathogenic substances in blood by utilizing the separation action of a hollow fiber membrane. For example, if a hemodialysis device is taken as an example, a bundle of thousands of hollow fiber membranes is bundled.
  • the blood to be treated blood collected from the patient's vein
  • the dialysate counter-flows outside the hollow fiber membrane (outside the lumen). It flows in (referred to as countercurrent operation).
  • countercurrent operation the concentration difference as a driving force.
  • the blood is permeated and excreted in the dialysate, and the purified blood is returned to the patient's vein.
  • Such a hemodialysis apparatus generally has a structure as shown in FIG. 1, and a hollow fiber membrane bundle 4 is accommodated in a long, tubular (cylindrical) housing 2.
  • a blood inlet 5.1 and outlet 5.2 are formed at both ends, and a dialysate port inlet 7.1 and outlet 7.2 are formed at the outer periphery of the tubular housing near both ends.
  • the main body of the cylindrical housing usually filled with a hollow fiber membrane, is gradually expanded from the small diameter portion 2.1 (which is the diameter of the housing) at both ends via the transition portion 2.3, and the maximum diameter expansion Part (large diameter part 2.2). Both ends of the maximum diameter-expanded portion 2.2 are sealed with cap members 8, and the treated blood inlet 5.1 and outlet 5.2 are formed through the cap members 8 at both ends.
  • the main body of the cylindrical housing usually filled with a hollow fiber membrane
  • the dialysate flowing from the dialysate port formed on the side of the tubular housing crosses the end of the hollow fiber membrane bundle arranged in the longitudinal direction of the housing (substantially at right angles (vertical)).
  • the hollow fiber membrane bundle is damaged by the collision, the arrangement is disturbed, and the treatment efficiency of the hemodialyzer is lowered. Further, blood leaks from the damaged part. The problem arises that driving cannot be continued smoothly.
  • the dialysate cannot be dispersed throughout the hollow fiber membrane bundle (induction of drift), there is also a problem that the efficiency of the dialyzer is significantly reduced.
  • an obstacle member also referred to as “baffle plate (or cylinder)”
  • the dialysate port inlet 7.1 so as to face the port, and the dialysate While the collision between the flow and the hollow fiber membrane bundle is eased, the dialysate is dispersed and rectified to counter-contact with the hollow fiber membrane bundle.
  • the basic purpose of the obstruction member is to improve the dialysis efficiency by improving the inflow state of the dialysis solution.
  • a tongue shape, a plate shape, a rod shape, and an annular shape also referred to as a cylindrical shape or a ring shape
  • the blood processing apparatus has a problem that air (also referred to as air) is mixed with the dialysate during dialysis. If air is mixed in the device, the space occupied by the air will not be a liquid / solid / liquid system, which is formed by dialysate / hollow fiber membrane / blood, which is the premise of dialysis. The diffusion and movement of the pathogenic substance in the blood through the membrane is not smoothly performed, and thus the blood purification efficiency is greatly reduced. Therefore, it is essential to perform priming in advance to remove air existing in the apparatus, and to remove air mixed and accumulated during the dialysis operation as needed.
  • air also referred to as air
  • the air is likely to be stored particularly at the end portion (the enlarged diameter portion or the large diameter portion) of the casing (hereinafter, the space of the large diameter portion where the air is easily stored is referred to as SP).
  • SP the space of the large diameter portion where the air is easily stored
  • These mixed air is air-operated by inclining the casing angle or applying vibration to a blood treatment device (usually operating with the blood inlet at the top and the blood outlet at the bottom).
  • a blood treatment device usually operating with the blood inlet at the top and the blood outlet at the bottom.
  • Patent Document 1 makes it possible to quickly perform a priming operation by enlarging a discharge port of air from the space SP and allowing air to easily escape to the dialysate port outlet direction without staying in the space SP.
  • an inclined portion that is inclined from a long portion toward a short portion is provided.
  • the dialysate shielding part is extended from the base end part of the obstacle member toward the tip part at a position facing the dialysate port inlet of the obstacle member.
  • the inclined part is formed from both ends of the shielding part, and the top end of the shielding part is arranged at substantially the same position as the end part of the opening of the dialysate port inlet on the longitudinal side of the housing.
  • the present applicant pays attention to a conventionally known annular (cylindrical) obstacle member, and based on detailed observations that have been rarely performed on blood treatment apparatuses having such an obstacle member having an entire circumference.
  • annular cylindrical
  • the problem of the present invention is that the function of improving the inflow state of the dialysate and improving the dialysis efficiency of the original obstructing member is not substantially impaired, and air is not rapidly retained in the space. It is providing the obstruction member comprised easily in the dialysate port exit direction, and the blood processing apparatus provided with the said obstruction member.
  • the present invention relates to a blood processing apparatus (1), and the blood processing apparatus is arranged inside a housing (2) along a longitudinal L direction of the housing (2) with a hollow fiber membrane bundle ( 4)
  • the distal DE side and the proximal end PE side of the hollow fiber membrane bundle (4) are fixed to the inner surface of the distal DE side and the proximal end PE side of the housing (2) by the fixing material (3), respectively.
  • a dialysate port inlet (7.1) is mounted on the terminal DE side of the housing (2) and in the direction of the first side S1
  • a dialysate port outlet (7.2) is mounted on the base end PE side of the housing (2) and in the direction of the first side portion S1
  • a blood port outlet (5.2) is mounted on the terminal DE side of the housing (2)
  • a blood port inlet (5.1) is mounted on the proximal end PE side of the housing (2)
  • the obstruction member (11) has a substantially cylindrical shape
  • the obstruction member (11) of the dialysate port inlet (7.1) has a proximal end PE side fixed in the housing (2) and / or
  • the obstruction member (11) of the dialysate port outlet (7.2) has the terminal DE side fixed in the housing (2)
  • the obstacle member (11) forms an opening (11OP) in at least one place in the side S direction
  • the opening (11O) is formed along the longitudinal L direction
  • the opening (11O) has a proximal opening (11OPE) and a distal opening (11ODE)
  • the obstruction member (11) of the dialysate port inlet (7.1) is rounded in the direction of both sides S of the end side opening (11ODE), that is, both the third side S3 side and the fourth side S4 side.
  • Forming part (R) and / or The obstruction member (11) of the dialysate port outlet (7.2) is in the direction of both sides S of the proximal end side opening (11OPE), that is, on both the third side S3 side and the fourth side S4 side.
  • a blood processing device (1) having a rounded portion (R) is provided.
  • the obstruction member (11) of the dialysate port inlet (7.1)
  • the size (WDE) of the terminal side opening (11ODE) Forming larger than the size (WPE) of the proximal opening (11 OPE) and / or
  • the obstruction member (11) at the dialysate port outlet (7.2)
  • the size (WO) of the opening 11O is 0.1 to 49 mm
  • the obstruction member (11) at the dialysate port inlet (7.1) The size (WDE) of the terminal side opening (11ODE) is 0.3 to 55 mm
  • the size (WPE) of the base end side opening (11 OPE) is 0.1 to 45 mm
  • the obstruction member (11) at the dialysate port outlet (7.2) The size (WDE) of the end opening (11ODE) is 0.1 to 45 mm
  • the blood processing device (1) according to [1] or [2] is provided, wherein the size (WPE) of the proximal end side opening (11OPE) is 0.3 to 55 mm.
  • the blood treatment device according to any one of [1] to [3], wherein the curvature radius r of the rounded portion (R) of the opening (11O) is 1 to 60 mm. )I will provide a.
  • the present invention provides the blood processing apparatus (1) according to any one of [1] to [4], wherein the angle ⁇ of the rounded portion (R) is 0 ° to 60 °. .
  • the blood processing apparatus according to any one of [1] to [5], wherein the obstacle member (11) has the openings (11OP) formed at two or more locations in the side S direction.
  • the obstacle member (11) has the openings (11OP) formed at least in the second side S direction. 1) is provided.
  • the function of the original obstacle member 11, which improves the inflow state of the dialysate and substantially improves the dialysis efficiency, is substantially impaired. Without any stagnation and without the air staying in the space SP of the large-diameter portion 2.2 of the housing 2 that is particularly liable to be stored due to the action of the obstruction member, the direction of the proximal end PE of the housing 2 (dialysate port outlet) 7.2 direction) so that the air can be easily removed.
  • FIG. 1 is an overall side view of the blood processing apparatus of the present invention.
  • FIG. 2 is a sectional view in the longitudinal L direction of the blood processing apparatus of the present invention.
  • FIG. 3 is a partially enlarged view of the housing 2 in FIG. 2 on the terminal DE side.
  • FIG. 4 is a side view of FIG. 3 as viewed from the terminal DE side, and S1-S4 indicate positions corresponding to the time position of the timepiece.
  • FIG. 5 is a partially enlarged view seen from the second side S2 direction on the terminal DE side in FIG.
  • FIG. 6 is an enlarged view of the obstacle member as seen from the direction of the second side portion S2 in the slightly proximal direction PE.
  • FIG. 7 is a partially enlarged view of the vicinity of the rounded portion R of the obstacle member.
  • FIG. 1 is an overall side view of the blood processing apparatus of the present invention.
  • FIG. 2 is a sectional view in the longitudinal L direction of the blood processing apparatus of the present invention.
  • FIG. 3 is
  • FIG. 8 is an enlarged view of the obstruction member, where (A) is an enlarged view seen from the base end PE side, and (B) is an enlarged view seen from the terminal DE side.
  • FIG. 9 is a partially enlarged view of the vicinity of the rounded portion R of the obstacle member.
  • FIG. 10 is a partially enlarged view of the vicinity of the rounded portion R of the obstacle member. (In the figure, see the definitions below for the significance of the terminal, proximal, side, etc.)
  • proximal PE side or direction
  • proximal PE side or direction
  • Terminal DE side or direction
  • proximal PE side or direction
  • It means the 2 side (end part).
  • Center axis or center CL center or direction
  • “Longitudinal L (side or direction)” means the longitudinal direction of the housing 2 as shown in FIGS.
  • the “side portion S (side or direction)” means a direction that intersects the longitudinal L direction substantially perpendicularly as shown in FIG.
  • “First side portion S1 (side or direction)” means an end portion on the dialysate port inlet 7.1 side as shown in FIG. Referring to FIG. 4, it means the 9 o'clock direction in terms of the timepiece hand position.
  • “Second side portion S2 (side or direction)” means an end portion on the opposite side to the end portion on the dialysate port inlet 7.1 side, as shown in FIG. Referring to FIG.
  • the position of the timepiece means the 3 o'clock direction.
  • “Third side portion S3 (side or direction)” means “first side portion S1 (side or direction)” and “second side portion S2 (side or direction)” as shown in FIG. (Upper U side) position between.
  • the position of the timepiece means the 12 o'clock direction.
  • “Fourth side portion S4 (side or direction)” means “first side portion S1 (side or direction)” and “second side portion S2 (side or direction)” as shown in FIG. (On the lower D side) between. Referring to FIG. 4, the position of the timepiece means the 6 o'clock direction. (Definition 9) When simply described as “dialysate port 7”, it means both dialysate port inlet 7.1 and dialysate port outlet 7.2.
  • the configuration of the blood processing apparatus 1 of the present invention is as shown in the entire side view of FIG. 1 and the cross-sectional view in the longitudinal L direction of FIG. 2, and more specifically, for example, shown in a partially enlarged view of FIG. It is as follows. That is, the hollow fiber membrane bundle 4 is disposed inside the housing 2 along the longitudinal L direction of the housing 2, and the proximal end PE side and the terminal DE side of the hollow fiber membrane bundle 4 are connected to the housing 2 by the fixing material 3. It is fixed inside. More specifically, the housing 2 has an end DE side (blood outlet side) whose small diameter portion 2... 2 is directed toward the end DE side as illustrated in FIGS. 1, 2, 3, and 5. 1.
  • a dialysate port inlet 7.1 is attached to the first side S1 of the large diameter portion 2.2. Further, the proximal end PE side (blood inlet side) of the housing 2 has a large diameter portion 2.2 via a small diameter portion 2.1 and a transition portion 2.3 toward the proximal end PE side.
  • a dialysate port outlet 7.2 is mounted on the first side S1 of the large diameter portion 2.2.
  • a blood port inlet 5.1 is attached through the proximal end PE side (cap member 8) of the housing 2, and the blood port is placed on the distal DE side (cap member 8) of the housing 2. Passes through outlet 5.2.
  • the dialysate port inlet 7.1 is mounted on the terminal DE side (blood outlet port side) of the housing 2 in the first side S1 direction (clockwise 9 o'clock direction).
  • a dialysate port outlet 7.2 is mounted on the proximal end PE side (blood inlet port side) of the housing 2 in the direction of the first side portion S1.
  • the obstruction member 11 When viewed in the longitudinal direction L of the housing 2, the obstruction member 11 (on the terminal DE side is shielded at the position where the dialysate port inlet 7.1 is formed, as shown in FIG.
  • the terminal DE side obstruction member 11 is provided so as to oppose.
  • the obstruction member 11 proximal end PE side obstruction member 11, not shown
  • the obstruction member 11 is also formed at the position where the dialysate port outlet 7.2 is formed (proximal end PE side). Can be provided.
  • the material forming the housing 2 is not particularly limited.
  • a polycarbonate resin, a polypropylene resin, a polybutylene resin, a polystyrene resin, a polymethyl methacrylate resin, or the like is used, and the fixing material 3 is usually a polyurethane resin. Etc. are used.
  • the hollow fiber membrane is not particularly limited, but a commonly used polysulfone resin, polyether sulfone resin, polyaryl sulfone resin, ethylene-vinyl alcohol copolymer, polyvinyl alcohol resin, Cellulose acetate resin, polyamide resin, polyimide resin, polyacrylonitrile resin and the like are used.
  • the obstacle member 11 on the base PE side on the side where the dialysate port outlet 7.2 is formed is connected to the terminal DE side (on the dialysate port inlet 7.1 side).
  • the “proximal side PE side” of the obstruction member 11 is “terminal side DE side”, “terminal side DE side” is “base side PE side”, and “third side part”. It will be obvious to those skilled in the art that if the “fourth side portion” is replaced with the “fourth side portion”, the “third side portion” is replaced with the “third side portion”, and the same function is obtained. I think that the.
  • the obstacle member 11 has a so-called “substantially cylindrical shape” as illustrated in FIGS. 2, 4, 6, and the like.
  • the substantially cylindrical obstacle member 11 has a base PE side outer peripheral wall (circumferential end surface of the cylindrical body) and an inner peripheral wall (small diameter portion to transition portion) of the housing 2. It is fixed to the wall. More specifically, the obstruction member 11 arranged on the dialysate port inlet 7.1 side has the proximal end PE side fixed in the housing 2, and the obstruction member 11 arranged on the dialysate port outlet 7.2 side is connected to the terminal DE side. Is fixed in the housing 2.
  • the obstruction member 11 may be formed at either the dialysate port inlet 7.1 or the dialysate port outlet 7.2, or may be formed at both. However, it is preferable to form at least the dialysate port inlet 7.1.
  • the obstruction member 11 faces the lower part of the dialysate port at the position from the transition part 2.3 of the housing 2 to the middle of the large diameter part 2.2, that is, the inflow, as shown in FIG.
  • the incoming dialysate is shielded and the influent is dispersed.
  • the substantially cylindrical obstacle member 11 is disposed so as to cover the periphery of the hollow fiber membrane bundle, so that the entire circumference can be protected from the direct hit of the inflowing dialysate.
  • the housing 2 in the blood processing apparatus of the present invention has the large diameter portion 2.2 through the small diameter portion 2.1 and the transition portion 2.3 toward the terminal DE side.
  • the dialysate port inlet 7.1 is attached to the first side S1 of the large diameter portion 2.2.
  • the proximal end PE side has a large diameter portion 2.2 through a small diameter portion 2.1 and a transition portion 2.3 toward the proximal end PE side.
  • a dialysate port outlet 7.2 is attached to one side S1.
  • the obstacle member 11 is formed at a position from the transition portion 2.3 of the housing 2 to the middle of the large diameter portion 2.2.
  • the obstruction member 11 has an opening portion 110 formed on the second side portion S2 side as exemplified in FIGS.
  • the opening 11O having a specific shape is formed in at least one place in the side S direction of the substantially cylindrical obstacle member 11 as described above.
  • the opening 110 may be formed in at least one place in the side S direction.
  • the opening should be formed. Otherwise, it can be formed at any position.
  • the most preferable formation position of the opening portion 110 is the second side portion S2 direction in which air tends to stay as will be described later.
  • There are two or more openings 110 in each direction between S1, S2, S3, S4, S1-S2, between S2-S3, between S3-S4, and between S4-S1). You may arrange in combination.
  • 2 to 6 locations, 2 to 5 locations, 2 to 4 locations, or 2 to 3 locations, etc. are employed.
  • they are (S2 and S3), (S2 and S4), (between S2 and S2-S3), (between S2 and S2-S4), etc. (S2 and S3 and S4), (between S2 and S3 and S2-S3), (between S2 and S3 and S2-S4), (between S2 and S4 and S2-S3), (Between S2, S4, and S2-S4).
  • the number of openings 11O is too large, there is a concern that the function as an original obstacle member (that is, the function of improving the inflow state of dialysate and improving the dialysis efficiency) may be impaired.
  • the dialysate flowing from the dialysate port inlet S1 collides with the cylindrical obstruction member 11 at its 9 o'clock position (NN), and then clockwise along the outer periphery of the cylinder. It flows through a route of (NN ⁇ EE ⁇ SS) and / or counterclockwise (NN ⁇ WW ⁇ SS), and finally reaches a portion SS where an opening is formed. Thereby, the entrained air of the inflowing dialysate also reaches this opening.
  • the opening portion 110 is formed along the longitudinal L direction of the substantially cylindrical obstacle member 11, and the opening portion 110 is formed on the terminal DE side (blood outlet side). ) To the base end PE side (blood inlet side) continuously, that is, penetrating (communicating). As will be described later, mixed bubbles move (rise) from the distal end side to the proximal end side along the flow path, with the opening as a flow path. Therefore, in order for air venting to be performed smoothly, it is necessary for the opening 110 to form a through (communication) flow path.
  • the opening portion 11O penetrating in this way has a terminal side opening portion 11ODE and a base end side opening portion 11OPE to be more accurate.
  • the opening 110 is formed to penetrate.
  • the dialysate port inlet 7.1 is used in this way.
  • the obstructive member 11 disposed opposite to the first is, as a basic idea, the size WDE of the distal side (blood outlet side) opening 11ODE is larger than the size WPE of the proximal side (blood inlet side) opening 11OPE. It is a large formation.
  • the blood processing apparatus is erected and operated, with the large opening 11ODE on the distal side (blood outlet side) being the lower part and the small opening 11OPE on the proximal side (blood inlet side) being the upper part. Installed.
  • the large opening 11ODE which is greatly expanded downward, spreads in a so-called funnel shape, and as shown in FIG. The effect to collect will be played. And, as shown in FIG. 7, the collected small air bubbles Ab collide and coalesce in close proximity to each other while moving along a flow path that gradually narrows upward. Larger bubbles are formed. The large bubbles formed in this manner quickly rise along the hollow fiber membrane bundle and are removed from the system from the dialysate port outlet formed in the upper part of the housing. This is the basic idea of the present invention and has never existed in the past.
  • the transition from the large opening to the small opening is defined as a smooth curve defined by R.
  • the present invention is characterized in that the rounded portions R are formed on both sides of the end opening 11ODE, that is, on both the third side S3 side and the fourth side S4 side. More precisely, the obstruction member 11 at the dialysate port inlet 7.1 is in the direction of both sides S of the end opening 11ODE, that is, both the third side S3 side and the fourth side S4 side. A round portion R is formed.
  • the rounded portion R means that the opening is expressed by a curve as a part of a circular arc.
  • the obstacle member 11 is installed at the dialysate port outlet 7.2 for the sake of safety.
  • the rounded portion R is formed in both sides S direction of the proximal end side opening 11OPE, that is, both the third side S3 side and the fourth side S4 side.
  • RI indicates the starting point of the round portion R (the rounding start point RI, that is, the starting point of the large opening), and RE is the end point of the round portion R (the round end point RE). That is, it is the end point of the large opening and the start point of the small opening).
  • the openings 110 are basically formed at substantially equal intervals (substantially linear) so that the small openings are along the longitudinal direction from the rounded end point RE toward the base end PE direction.
  • the opening 110 is slightly (or slightly) narrower from the rounded end RE toward the base PE so that the small opening is along the longitudinal direction. You may form in what is called a taper taper shape.
  • the size (width) of the opening 11O varies depending on the position, and is defined as follows.
  • the size WO of the opening 11O basically means a linear distance between the third side S3 side and the fourth side S4 side of the equally spaced (substantially linear) portion.
  • the opening portion 110 is formed in a tapered shape, it means a distance between the third side portion S3 side and the fourth side portion S4 side of the rounded end point RE.
  • size WDE of the terminal side opening part 11ODE is the radius start point RI / S3 on the 3rd side part S3 side, and the radius start point on the 4th side part side.
  • the size WPE of the base end side opening 11OPE means the distance between the R end point RE / S3 on the third side S3 side and the R end point RE / S4 on the fourth side S4 side. More precisely, the sizes WDE and WPE, as illustrated in FIG. 8A showing the WPE and FIG. 8B showing the WDE, the third side S3 side end and the fourth side S4 side This means the linear distance (m, m ′) between the ends. Similarly, the size WO means a linear distance.
  • the obstruction member 11 of the dialysate port inlet 7.1 is formed such that the size WDE of the distal side opening 11ODE is larger than the size WPE of the proximal side opening 11OPE.
  • the obstruction member 11 at the dialysate port outlet 7.2 is formed such that the size WPE of the proximal end opening 11OPE is larger than the size WDE of the distal opening 11ODE. It is as follows. (I) The size WO of the opening 11O is 0.1 to 49 mm, preferably 1.5 to 5 mm. (Ii) The obstruction member 11 at the dialysate port inlet 7.1 is formed so that the size WDE of the terminal opening 11ODE is 0.3 to 55 mm, preferably 5 to 20 mm.
  • the size WPE of the base end side opening 11OPE is 0.1 to 45 mm, preferably 1 to 4 mm.
  • the obstruction member 11 at the dialysate port outlet 7.2 is formed so that the size WDE of the terminal opening 11ODE is 0.1 to 45 mm, preferably 1 to 4 mm.
  • the size WPE of the base end side opening 11OPE is 0.3 to 55 mm, preferably 7 to 20 mm.
  • the original obstacle member also referred to as “baffle plate (cylinder)”.
  • the original obstacle member also referred to as “baffle plate (cylinder)”.
  • the size of the opening is formed in the above numerical range, the original function as an obstructing member can be maintained and the air escape effect can be sufficiently achieved.
  • the radius of curvature r of the rounded portion R (which is a part of the arc) is preferably 1 to 60 mm, and more preferably 1.5 to 10 mm.
  • the size WDE of the terminal opening 11ODE can be increased. If the radius of curvature r is too large, for example, exceeding 60 mm, the size WDE of the terminal opening 11ODE becomes too large, and the original obstacle member (also referred to as “baffle plate (cylinder)”) is used.
  • the radius of curvature r is too small, such as less than 1 mm, the size WDE of the terminal opening 11ODE becomes too small, and an air escape effect cannot be expected.
  • the explanation of the radius of curvature r of the obstruction member 11 at the dialysate port outlet 7.2 is “the proximal end opening 11 OPE” is replaced with “the proximal end opening 11 OPE”. Since it is good, detailed description is abbreviate
  • the angle ⁇ of the rounded portion R is defined in order to evaluate the case where the opening 110 is formed in a tapered shape. That is, ⁇ is an inclined line RS and an extension line LL (parallel to the central axis CL) in the vicinity of the end point RE of the rounded portion R, as illustrated in FIG. 10 [an enlarged view further exaggerating a part of the base PE direction in FIG. 9].
  • the angle ⁇ of the R portion defined in this way is a so-called connection angle from the curve of the round portion R to a straight line, and in the present invention, it is formed at 0 ° to 60 °, preferably 1 ° to 5 °. Is good. If the angle ⁇ is too large, for example, exceeding 5 °, the size WDE of the terminal opening 11ODE becomes too large, and the inflow state of the dialysate, which is the original function as an obstacle member, is improved. In addition, the function of improving dialysis efficiency is impaired, which is not preferable. On the other hand, if ⁇ is a very small value such as less than 1 °, the size WDE of the terminal opening 11ODE becomes too small, and an air escape effect cannot be expected.
  • the angle ⁇ is 0 °.
  • the opening portion 110 can be formed in a tapered shape.
  • the explanation of the angle ⁇ of the rounded portion R is as follows. , “Base PE side” is “terminal DE side”, “terminal DE side” is “base PE side” and “terminal side opening 11ODE” is “base side opening” 11OPE ”, and detailed description thereof will be omitted.
  • the dialysate flows from the dialysate port inlet 7.1 (in the first side portion S1 direction) to the terminal DE side (blood outlet side) of the housing 2.
  • the dialysate collides with the wall surface NN on the first side S1 side of the obstacle member 11, and detours along the wall surface EE of the third side portion S3 and / or the wall surface WW of the fourth side portion S4. It moves to the wall surface SS on the second side S2 side.
  • the dialysate flows along the wall surface of the obstacle member 11 in the order of NN ⁇ EE ⁇ SS and / or NN ⁇ WW ⁇ SS. Note that an opening 110 is formed in the SS as shown in the figure.
  • the dialysate flows into the cylinder beyond the circumferential end surface ( ⁇ ) of the substantially cylindrical obstacle member, the flow direction is inevitably in the longitudinal direction of the housing (that is, the hollow fiber membrane). Direction parallel to the bundle). That is, it flows in the direction of the proximal end PE of the housing 2 along the hollow fiber membrane bundle.
  • the air entrained by the dialysate in the large-diameter portion 2.2 of the housing 2 (the transition portion 2.3 to), or generated here, or previously stored in this portion is the dialysate described above.
  • the position of the wall surface on the second side portion S2 side moves to position SS.
  • the air (bubble) Ab that has reached the SS portion moves toward the proximal end opening (11 OPE side) along the rounded portion R of the distal opening 11ODE shown in FIG.
  • the air (bubbles) Ab moves along the flow path formed so as to become gradually narrower upward, and collides with each other to merge and unite. Bubbles Ab are formed. (Or, from the coarse dispersion state of the bubbles, the state becomes a denser bubble group Ab.)
  • the large air bubbles (or close bubble groups) formed in this way are further along the hollow fiber membrane bundle.
  • the inside of the housing quickly rises, and is finally removed from the dialysate port outlet formed at the top of the housing.
  • the obstacle member of the present invention is formed so as to be gradually narrowed from the wide opening as defined by the distal opening 11ODE and the rounded portion R. Quick removal to the PE side is promoted.
  • Example 1 (Test equipment) (1) The test which confirms the air bleeding effect of the obstruction member 11 (cylindrical shape in which a single opening portion 110 is formed) in the blood processing apparatus 1 of the present invention was conducted.
  • the blood processing apparatus 1 used was the one shown in FIGS. 1 and 2 and subjected to high-pressure steam sterilization.
  • the hollow fiber membrane bundle 4 is made of polysulfone resin and has a membrane area of 2.0 m 2
  • the fixing material 3 is a polyurethane resin (manufactured by Nippon Polyurethane Industry Co., Ltd.). However, (i) the end portion of the fixing material 3 (polyurethane resin) was cut, and (ii) the blood ports (5.1, 5.2) were welded to the housing 2.
  • the opening part 110 has a shape as shown in FIG. 6 and has a size WO: 2.7 mm and a size WDE of the opening part 11 ODE on the terminal side (blood outlet side): 10.8 mm, the size WPE of the proximal end (blood inlet side) opening 11OPE: 2.4 mm, and the radius R, the radius of curvature r of the radius R shown in FIG. 9 is 4 mm, as shown in FIG. An angle ⁇ of the rounded portion R was formed at 2 °.
  • a liquid feed pump was disposed in the middle of the silicone tube connected to the dialysate port inlet 7.1 side.
  • a silicone tube filled with pure water (distilled water) in advance is clamped with a clamp, and pure water (distilled) from the clamped position to the connector opening. Connection was made after removing (water). If the inner volume of the tube from which this water was removed is Va, the tube will contain air of volume Va.)
  • Example 1 the blood processing apparatus of the present invention (Example) has less air remaining than the blood processing apparatus of the comparative example, and air leakage during dialysis fluid priming is reduced. It was confirmed that there is an effect that makes it very easy.
  • Example 2 Comparative Example 2 (Test equipment)
  • the test was performed by changing the size WO of the opening portion 110.
  • the blood processing apparatus is basically the same as that of the first embodiment except that the end of the fixing material 3 (polyurethane resin) is not cut and the blood port (5.1, 5.2) is a housing. It differs only in that it is not welded to 2.
  • Test results The results of evaluation items (1) and (2) are summarized in Table 2. From Table 2, the blood treatment apparatus for the obstacle member in which the opening of the present invention (Example 2) is formed is more air priming than the blood treatment apparatus for the obstacle member in which the opening of Comparative Example 2 is not formed. It was confirmed that the removal effect was remarkably improved. It has been confirmed that the time until the air escapes can be shortened by increasing the size of the opening 11O.
  • the flow around the inlet of the dialysate was confirmed in detail by visual inspection (photographing) using this obstructing member, but the supplied dialysate did not directly collide with the hollow fiber membrane bundle as in the initial purpose. It was confirmed that the flow was favorably distributed as a flow from the circumferential end of the end of the obstructive member toward the center.
  • the function of the obstacle member is not substantially impaired, and air introduced into the apparatus that lowers the efficiency of the apparatus can be promptly retained without remaining in the apparatus space. Since a blood processing device with an obstacle member that can easily be pulled out of the device is provided, the industrial applicability in the medical field where blood processing devices such as hemodialysis, blood filtration, hemodiafiltration, and plasma separation are used. Is big.

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
PCT/JP2013/073798 2012-09-27 2013-09-04 Dispositif de traitement de sang Ceased WO2014050468A1 (fr)

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Cited By (4)

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Publication number Priority date Publication date Assignee Title
US10022484B2 (en) 2013-02-06 2018-07-17 Nxstage Medical, Inc. Fluid circuit priming methods, devices, and systems
US10279098B2 (en) 2015-04-07 2019-05-07 Nxstage Medical, Inc. Blood treatment device priming devices, methods, and systems
JPWO2018062073A1 (ja) * 2016-09-30 2019-07-11 東レ株式会社 培養血小板濃縮モジュールおよびそれを用いた血小板製剤の製造方法
JP2019122770A (ja) * 2018-01-11 2019-07-25 ベー・ブラウン・アヴィトゥム・アー・ゲーＢ． Ｂｒａｕｎ Ａｖｉｔｕｍ Ａｇ 水平配置用の中空ファイバフィルタモジュールを有する血液処理装置と中空ファイバフィルタモジュール並びにその利用法

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JPS6035704U (ja) * 1983-08-11 1985-03-12 日機装株式会社 中空糸型透析器
JP2010148654A (ja) * 2008-12-25 2010-07-08 Kawasumi Lab Inc 血液処理装置

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JP4726045B2 (ja) * 2005-04-08 2011-07-20 日機装株式会社 血液透析装置
JP5443005B2 (ja) * 2009-01-15 2014-03-19 川澄化学工業株式会社 血液処理装置

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JPS52138071A (en) * 1976-03-19 1977-11-17 Organon Teknika Bv Separation apparatus
JPS6035704U (ja) * 1983-08-11 1985-03-12 日機装株式会社 中空糸型透析器
JP2010148654A (ja) * 2008-12-25 2010-07-08 Kawasumi Lab Inc 血液処理装置

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10022484B2 (en) 2013-02-06 2018-07-17 Nxstage Medical, Inc. Fluid circuit priming methods, devices, and systems
US10835662B2 (en) 2013-02-06 2020-11-17 Nxstage Medical, Inc. Fluid circuit priming methods, devices, and systems
US11344658B2 (en) 2013-02-06 2022-05-31 Nxstage Medical, Inc. Fluid circuit priming methods, devices, and systems
US12083259B2 (en) 2013-02-06 2024-09-10 Nxstage Medical, Inc. Fluid circuit priming methods, devices, and systems
US10279098B2 (en) 2015-04-07 2019-05-07 Nxstage Medical, Inc. Blood treatment device priming devices, methods, and systems
US10987461B2 (en) 2015-04-07 2021-04-27 Nxstage Medical, Inc. Blood treatment device priming devices, methods, and systems
US11679190B2 (en) 2015-04-07 2023-06-20 Nxstage Medical, Inc. Blood treatment device priming devices, methods, and systems
US11969534B2 (en) 2015-04-07 2024-04-30 Nxstage Medical, Inc. Blood treatment device priming devices, methods, and systems
JPWO2018062073A1 (ja) * 2016-09-30 2019-07-11 東レ株式会社 培養血小板濃縮モジュールおよびそれを用いた血小板製剤の製造方法
JP7139604B2 (ja) 2016-09-30 2022-09-21 東レ株式会社 培養血小板濃縮モジュールおよびそれを用いた血小板製剤の製造方法
JP2019122770A (ja) * 2018-01-11 2019-07-25 ベー・ブラウン・アヴィトゥム・アー・ゲーＢ． Ｂｒａｕｎ Ａｖｉｔｕｍ Ａｇ 水平配置用の中空ファイバフィルタモジュールを有する血液処理装置と中空ファイバフィルタモジュール並びにその利用法
JP7319781B2 (ja) 2018-01-11 2023-08-02 ベー・ブラウン・アヴィトゥム・アー・ゲー 水平配置用の中空ファイバフィルタモジュールを有する血液処理装置と中空ファイバフィルタモジュール並びにその利用法

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JP6203186B2 (ja) 2017-09-27

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