JP6832097B2 - Blood processor - Google Patents

Description

The present invention relates to a blood processor used in a medical device such as a blood collection device, a hemodialysis, a blood circuit used for blood purification, and the like.

The applicant has disclosed in Patent Documents 1 and 2 the invention of a blood treatment device (leukapheresis device) in which a non-woven fabric is loaded as a blood treatment member (blood filter) in a flexible housing.

Further, Patent Document 3 describes unevenness with a height difference of 0.2 to 2 mm on the inner surface of a flexible housing (soft resin bag-shaped housing) facing the surface of the outflow side blood chamber of the blood treatment member (white blood cell removal filter member). (Specifically, the hemofiltration rate is reduced by forming a plurality of ribs 23 (paragraphs [0028] to [0033]) extending substantially parallel to the other end side (in other words, the blood flow direction) from one end side. Discloses the invention of a blood treatment device (leukocyte remover), which is less likely to cause poor adhesion of the housing.
Further, Patent Document 3 uses a sponge-like polyurethane porous body as a blood treatment member, sets the number of stacked porous bodies to 6 (up to 10), and sets the outermost edge of the blood treatment member as an outer frame. It is fixed to the flexible housing via (sheet). As a result, a blood flow path between the outer frame sheet and the inner surface of the flexible housing is formed at the peripheral edge portion inside the flexible housing to improve blood circulation at the peripheral edge portion inside the flexible housing and to improve the peripheral edge. Prevents residual blood in the part.

In Patent Document 4, the non-woven fabric is fixed to the flexible housing by the inner seal portion (first seal portion) and the outer seal portion (second seal portion) without using the outer frame (sheet), and the inner seal is provided. The invention discloses an invention in which a blood inlet (upper side) and a blood outlet (lower side) are attached to the inside of the portion.
Further, in the invention described in Patent Document 5 (*) listed in FIGS. 8 to 10, the blood processing member 105 is made of the flexible housing 102 (first housing 102 / U, second housing 102 /) as in Patent Document 3. It is placed in D). [(*) In order to make it easier to understand the comparison with each member of the present invention, a code of +100 is described in accordance with the code of each member of the present invention. ]
Since the space between the outer edge of the blood treatment member 105 and the inner circumference of the inner edge of the second housing 102 is formed sufficiently wide with a margin, the inner wall of the second housing 102 / D is formed on the surface (outside) of the blood treatment member 105. Easy to stick to the filter section).
In order to prevent the sticking, two soft tubes are arranged as the spacer T between the inner wall of the second housing 102 / D and the surface (outer filtration portion) of the blood treatment member 105. Specifically, the two soft tubes are fixed to the inner wall of the second housing 102 / D by welding.

Patent No. 3014916 (Claims, FIGS. 1 to 10) Patent No. 3049182 (Claims, FIGS. 1 to 6) Patent No. 3758853 (Claims [0028] to [0033], FIGS. 1 to 10) Patent No. 4038547 (Claims, Fig. 2, Fig. 3, Fig. 4) European Publication No. 0526678 (Fig. 2, Fig. 4, Fig. 5, Description of the Invention / Columns 4 to 5)

Since the blood treatment devices of Patent Documents 1 to 4 use a flexible housing, the internal space of the flexible housing on the blood outflow chamber side becomes negative pressure as the blood is filtered, and therefore the housing is concerned. Tends to crush and block the blood flow path near the blood outlet. As a result, there is a concern that the blood filtration rate may decrease.
As in the invention described in Patent Document 3, even if unevenness with a maximum height difference of 2 mm is formed on the inner surface of the flexible housing (bag-shaped housing made of soft resin), the blood flow near the blood outlet due to negative pressure It is not effective enough to prevent road blockage.

Further, in the invention of Patent Document 4, since holes must be formed in each of the blood inlet side sheet and the blood outlet side sheet of the flexible housing to attach the blood inlet and the blood outlet, as compared with Patent Document 3. Processing becomes difficult.
Further, in the invention of Patent Document 5, as shown in FIG. 8, a large space LSP is provided especially in the vicinity of the blood outlet 107O. Therefore, when the blood outflow chamber 102OR becomes negative pressure, the second housing 102 / D tends to close the opening 107OO of the blood outlet 107O.
Further, the spacer T (tube) fixes the entire spacer T (tube) to the inner wall of the housing by welding along the longitudinal direction of the housing 2, but the wall thickness of the flexible sheet used for the blood processor is originally high. Since it is about 0.4 mm, it is difficult to fix the spacer T (tube) as described above.
Further, when fixing (welding), the vicinity of the fixing (welding) portion is deformed and hardened, and blood does not flow smoothly in the blood outflow chamber 102OR, which may lead to blood retention, residual blood, and the like.

Therefore, the present inventor has reached the following invention as a result of repeated studies in order to solve the above problems.
The present invention includes a first housing and a second housing formed of a flexible sheet.
The first housing and the blood processing member arranged in the second housing are provided.
The blood processing member is
An inner filtration section located on the first housing side and partitioning the blood inflow chamber together with the inner surface of the first housing.
It is located on the side of the second housing and has an outer filtration section that partitions the blood outflow chamber together with the inner surface of the second housing.
Further provided with a spacer which is arranged in the blood outflow chamber and regulates the deformation of the second housing toward the outer filtration portion.
The spacer is
It is arranged between the inner wall of the second housing and the outer filtration portion in the blood outflow chamber so as to extend from the blood inlet side to the blood inflow chamber to the blood outlet side of the blood outflow chamber . A substantially tubular outflow chamber spacer fixed to the second housing at each end on the inlet side and the outlet side ,
With a tubular member having a blood outlet communicated with the blood outflow chamber,
The tubular member is inserted into the blood outflow chamber, and the communication port of the tubular member with the blood outflow chamber is located closer to the inlet side of the blood than the end of the outflow chamber spacer on the outlet side. It is supposed to be.

Even if the blood outflow chamber becomes negative pressure and the inner wall of the second housing tries to deform toward the outer filtration portion side of the blood treatment member, the outflow chamber spacer and the tubular member regulate the deformation of the inner wall of the second housing, and the second housing. 2 It is possible to prevent the contact between the inner wall of the housing and the outer filtration portion.
In addition, most of the outflow chamber spacers are not fixed to the inner wall of the second housing except for the ends on the inlet side and the outlet side of the blood, so that the retention of blood flow, residual blood, etc. are avoided as in the past. can do.
As a result, a sufficient blood flow path in the blood outflow chamber can be secured, so that blood can be discharged quickly, and the filtration time can be significantly shortened.

FIG. 1 is an overall view (plan view / schematic view) showing an embodiment of the blood processor 1 of the present invention. FIG. 2 is an overall view (bottom view / schematic view) showing an embodiment of the blood processor 1 of the present invention. FIG. 3 is an exploded perspective view showing an embodiment of the blood processor 1 of the present invention. FIG. 4 is a cross-sectional view taken along the line AA'of FIG. FIG. 5 is a usage state diagram (cross-sectional view) of the blood processor 1 of FIG. FIG. 6 is a usage state diagram (bottom view) of the blood processor 1 of FIG. 7 (A) and 7 (B) are plan views (schematic views) showing other examples of the spacer T. FIG. 8 is an overall view (plan view / schematic view) of the blood processor 101 described in Patent Document 5. 9 is a cross-sectional view taken along the line BB'of FIG. FIG. 10 is a cross-sectional view taken along the line CC'of FIG.

Hereinafter, the present invention will be described in detail with reference to the drawings.
Hereinafter, in order to clearly explain the blood processor 1 of the present invention, the following definitions are given with reference to the arrangement of the figures.
The base end PE side (or also referred to as a direction, the same applies hereinafter) means the blood inlet 7I side, for example, as shown in FIG.
The terminal DE side means, for example, the blood outlet 7O side as shown in FIG.
As shown in FIG. 1, for example, the first side portion S1 side means the direction on the right side of a line (substantially center line CL) connecting the blood inlet 7I and the blood outlet 7O in series.
As shown in FIG. 1, for example, the second side portion S2 side means the direction opposite to the first side portion S1 side, that is, the direction on the left side of the line connecting the blood inlet 7I and the blood outlet 7O in series.

The upper U side means the direction of the upper side of the paper surface. In FIG. 1, it means the direction of the front side of the paper.
The lower D side means the direction of the lower side of the paper surface. In FIG. 1, it means the direction on the back side of the paper.
The base end PE side, the end DE side, the first side portion S1, the second side portion S2, the upper U, and the lower U may be one direction of the side portion.
For example, the terminal DE side opposite to the base end PE side in one direction of the side portion may be referred to as one direction of the other side portion. The same applies to the case of the first side portion S1 and the second side portion S2, and the upper U and the lower U.

As shown in FIGS. 3 to 4, when the upper U and the lower D members are present as in the housing 2, for example, as in the blood processing member 2 / U, the reference numeral “2” is followed by “/ U”. When described as "2 / U", it means the blood processing member 2 / U on the upper U side. The same applies to the case of the outer frame sheet 3.
The housing 2 / U on the upper U side may be described as the first housing 2 / U, and the housing 2 / D on the lower D side may be described as the second housing 2 / D. The same applies to the case of the outer frame sheet 3.
If the upper U and lower D members are present, such as the housing 2 and the outer frame sheet 3, and appear in the drawing, they are "2 / U, 2 / D", "3 / U, 3 / D". Two kinds of codes are described as described above.

As shown in FIGS. 1 to 6, the blood treatment device 1 of the present invention includes a flexible housing 2 made of a flexible sheet (hereinafter, simply referred to as a housing 2) and a blood treatment loaded in the housing 2. It has a member 5.
The housing 2 includes a housing 2 / U on the upper U side and a housing 2 / D on the lower D side.

A tubular blood inlet 7I is attached to one end of the housing 2 on the base end PE side and the upper U side.
A tubular blood outlet 7O is attached to one end of the housing 2 on the terminal DE side and the lower D side. The blood outlet 7O has the base end PE side inserted deeply into the blood outflow chamber 2OR. The code of the insertion portion is hereinafter referred to as “7OI”.
The insertion portion 7OI functions in the same manner as the spacer T, as will be described later.
The outer diameter of the blood outlet 7O is formed in the same manner as the spacer T described later.
The length of the insertion portion 7OI (see FIG. 4) is formed to be 20 mm to 50 mm.
The tubular blood inlet 7I and blood outlet 7O are made of a harder resin than the flexible housing 2.
The blood treatment member 5 is formed by laminating a plurality of non-woven fabrics.

Further, a substantially tubular (or tubular) spacer T is arranged between the inner wall of the lower housing 2 / D and the outer filtration portion 5O. The spacer T means a member that provides a space between the inner wall of the lower housing 2 / D (upper housing 2 / U) and the outer filtration portion 5FO (inner filtration portion 5FI).
The outer diameter of the spacer T is formed to be 3 mm to 10 mm.
If it is less than 3 mm, the effect of preventing the inner wall of the lower housing 2 / D from coming into close contact with the outer filtration portion 5FO when the blood outflow chamber 2OR becomes negative pressure is not sufficient.
If it exceeds 10 mm, it is too large, and it becomes difficult to fix both ends of the spacer T on the base end PE side and the end end DE side to the housing 2 (as the housing seal portion 2S and the outer frame seal portion 3S described later).

The shape of the spacer T is formed into a substantially curved shape or the like as shown in FIG. 7 (B) in addition to a substantially linear shape as illustrated in FIG. 2 when viewed from the lower D (or upper U) direction. Is also good.
In FIG. 2, the spacer T is described as being slightly curved.
This is because the blood treatment member 5 is laminated as described above, so that the inside is three-dimensionally raised as compared with the edge portion. After the spacer T is fixed to the housing 2, it is in a slightly curved state as shown in FIG.
On the other hand, the spacer shown in FIG. 7B is intentionally curved to form a substantially curved shape.

As shown in FIG. 2, the arrangement of each spacer T is arranged on the first side portion S1 and the second side portion S2 so as to be along the terminal DE side from the base end PE with the substantially center line CL symmetrical. By arranging the center lines CL symmetrically, blood can flow uniformly on the first side portion S1 side and the second side portion S2 side, and thus the filtration time can be shortened.
Further, the spacer T similar to each of the spacers T can be arranged between the inner wall of the upper housing 2 / U and the inner filtration portion 5FI side in the same manner as described above. As a result, the blood flow path in the blood inflow chamber 2IR can be widely secured from the proximal PE side to the distal DE side, so that the blood flowing into the blood inflow chamber 2IR from the blood inlet 7I can be promptly secured by the blood processing member 5. Can be filtered. Therefore, the filtration time can be further shortened.

The number of spacers T is arranged from at least 2 to a maximum of 10.
The effect of preventing the inner wall of the lower housing 2 / D from coming into close contact with the outer filtration portion 5O is not sufficient with one.
If the number exceeds 10, the distance between the spacers T becomes too narrow and the blood flow path is obstructed.
In FIG. 2, one is arranged in each of the first side portion S1 and the second side portion S2, and two are arranged in total, but the present invention is not limited to these. Two to five [see FIG. 7 (A)] may be arranged substantially in the center line CL symmetry in the directions of the first side portion S1 and the second side portion S2, respectively.

Hereinafter, an embodiment of the blood processor 1 will be described together with an embodiment of the manufacturing process.
As shown in FIG. 3, the blood processing member 5 and the outer frame sheet 3 are fixed.
More specifically, the blood treatment member 5 fixes the outer edge between the inner edge of the upper outer frame sheet 3 / U and the lower outer frame sheet 3 / D.
These fixings can be performed by welding by external heating by heat sealing, internal heating by high frequency, ultrasonic waves, or the like.
The fixed portion between the blood treatment member 5 and the outer frame sheet 3 may be hereinafter referred to as a "seal portion 5S". The non-fixed portion inside the blood processing member 5 and the outer frame sheet 3 may be referred to as a filtration portion 5F. The surface on the blood inflow chamber 2IR side may be referred to as the inner filtration section 5FI, and the surface on the blood outlet 2OR side may be referred to as the outer filtration section 5FO.
Further, the outer edges of the upper outer frame sheet 3 / U and the lower D side outer frame sheet 3 / D are also fixed.
These fixed portions may be hereinafter referred to as "outer frame seal portion 3S (3S / U, 3S / D)".

Further, an upper extension portion 3L / U is formed on the base end PE side of the upper outer frame sheet 3 / U, and a lower extension portion 3L / D is formed on the terminal DE side of the lower outer frame sheet 3 / U. There is.
The fixed portion (seal portion 5S) between the blood treatment member 5 and the outer frame sheet 3 is in a state in which the blood treatment member 5 is compressed as compared with the non-fixed portion (filtration portion 5F) inside the seal portion 5S. Become.

The blood processing member 5 fixed to the outer frame sheet 3 is covered with a pair of upper and lower sheets SH / U and SH / D (which form a housing 2 / U on the upper U side and a housing 2 / D on the lower D side).
That is, they are arranged as follows from the upper U side to the lower D side.
On the base end PE side, the upper side sheet SH / U, the blood inlet 7I, the upper side extension portion 3L / U, (blood treatment member 5 fixed to the outer frame sheet 3 / U, 3 / D), the spacer T and the lower side. The sheets are arranged in the order of SH / D.
On the terminal DE side, the upper sheet SH / U, (blood processing member 5 fixed to the outer frame sheet 3 / U, 3 / D), the lower extension 3L / D, the blood outlet 7O, the spacer T, and the lower sheet. Arrange in the order of SH / D.

Subsequently, the corners CR / S1 and CR / S2 on the first side portion S1 side and the second side portion S2 side are fixed by heat sealing. The fixed portion may be hereinafter referred to as "corner seal portion SCR".

Subsequently, on the base end PE side, the upper side sheet SH / U, the blood inlet 7I, the upper side extension portion 3L / U, (the blood treatment member 5 fixed to the outer frame sheet 3 / U, 3 / D) and the lower side sheet. SH / D, on the terminal DE side, upper sheet SH / U, (blood processing member 5 fixed to outer frame sheet 3 / U, 3 / D), lower extension 3L / D, blood outlet 7O and lower side The sheet SH / U and its periphery (edge, vicinity) are fixed by heat sealing.
The fixed portion may be hereinafter referred to as "base end side sealing portion 2SPE, terminal side sealing portion 2SDE".
The base end PE side and the terminal DE side may be fixed at the same time, the base end PE side may be fixed first, and then the terminal DE side may be fixed, or the terminal DE side may be fixed first. After fixing, the base end PE side may be fixed.

Subsequently, the outer frame seal portions 3S / U and 3S / D on the outer edges of the four sides (hypotenuse) of the blood treatment member 5 are fixed to the upper sheet SH / U and the lower sheet SH / D by heat sealing.
The fixed portion may be hereinafter referred to as "seal portion 2S". At this time, the base end PE side and the end end DE side of the spacer T are fixed to the housing seal portion 2S and the outer frame seal portion 3S. The fixing portion may be referred to as "spacer fixing portion (or seal portion) 2TS".
The unnecessary outer edge sheets SH / U and SH / D are removed (cut) from the respective seal portions 2S and SCR to complete the blood processor 1 of FIG. 1 as described above.

Further, the form of the blood processor 1 will be described.
For example, as shown in FIG. 4, on the base end PE side, the portion where the blood inlet 7I is attached is from the upper U side to the lower D side, the upper housing 2 / U ⇒ blood inlet 7I ⇒ upper extension portion. It is fixed in the order of 3L / U ⇒ lower housing 2 / D.
The base end PE side of the blood treatment member 5 is fixed by the upper extension portion 3L / U via the outer frame seal portion 3S / U of the upper outer frame sheet 3 / U.
The base end PE side of the spacer T is fixed between the outer frame seal portion 3S and the lower housing 2 / D.

On the terminal DE side, the place where the blood outlet 7O is attached is from the upper U side to the lower D side, upper housing 2 / U ⇒ lower extension 3L / D ⇒ blood outlet 7O ⇒ lower housing 2 / It is fixed in the order of D.
The terminal DE side of the blood treatment member 5 is fixed to the lower extension portion 3L / D via the outer frame seal portion 3S / D of the lower outer frame sheet 3 / D.
The terminal DE side of the spacer T is fixed between the outer frame seal portion 3S and the lower housing 2 / D.
When the spacer T is arranged in the blood inflow chamber 2IR, the base end PE side of the spacer T is arranged and fixed between the outer frame sealing portion 3S and the upper housing 2 / U in the same manner as described above. The terminal DE side of the spacer T is arranged and fixed between the outer frame seal portion 3S and the upper housing 2 / U in the same manner as described above.

The base end PE side of the blood outlet 7O is inserted into the inside of the blood outflow chamber 2OR of the housing 2. The blood outlet 7O forms a side hole 8 in the vicinity of the fixed portion (terminal side sealing portion 2SDE side). The side holes 8 may be formed at two locations, but may be formed at three or four locations. Blood can be rapidly drained from the terminal DE side of the blood outflow chamber 2OR.

Further, the internal structure of the housing 2 will be described in detail.
The space between the inner circumference of the upper housing 2 / U and the inner filtration portion 5FI of the blood processing member 5 is a blood inflow chamber 2IR.
The space between the inner circumference of the lower housing 2 / D and the outer filtration portion 5FO of the blood processing member 5 is a blood outflow chamber 2OR.
The blood inlet 7I communicates with the blood inflow chamber 2IR, and the blood outlet 7O communicates with the blood outflow chamber 2OR.
The above-mentioned two spacers T are arranged inside the blood outflow chamber 2OR.

Next, the blood flow of the blood processor 1 will be described.
As illustrated in FIGS. 5 and 6, blood flows into the blood inflow chamber 2IR from the base end PE side of the blood inlet 7I through the opening 7IO on the terminal DE side.
The blood in the blood inflow chamber 2IR passes from the inner filtration section 5FI through the outer filtration section 5FO and moves into the blood outflow chamber 2OR.
Even if the inside of the blood outflow chamber 2OR becomes negative pressure and the inner wall of the lower housing 2 / D tries to be deformed in the direction of contacting the outer filtration portion 5OF side of the blood processing member 5, the inner wall of the second housing 2 / D The spacer T arranged between the outer filtration unit 5OF side and the outer filtration unit 5OF side prevents contact with the outer filtration unit 5OF side.

Further, since the base end PE side of the blood outlet 7O is deeply inserted into the blood outflow chamber 2OR, the insertion portion 7OI has the same function as the spacer T.
The opening 7OO of the blood outlet 7 is arranged on the base end PE side of the fixing portion 2TS on the terminal DE side of the spacer T.
Therefore, in the region A near the opening 7OO of the blood outlet 7O, the blood flow path is not narrowed by the inner wall of the lower housing 2 / D.
Since the spacer T is not fixed to the inner wall of the housing 2 / D as in Patent Document 5, retention of blood flow, residual blood, and the like can be avoided as in Patent Document 5.
As described above, since the blood flow path in the blood outflow chamber 2OR can be sufficiently secured, blood can be discharged quickly, and the filtration time can be significantly shortened.
Further, the side hole 8 of the blood outlet 7O (formed in the vicinity of the terminal side sealing portion 2SDE) can further promote the outflow of blood, and the filtration time can be further shortened.

[Blood processing member]
As the constituent material of the blood treatment member 5, a non-woven fabric is used as described above.
The material of the non-woven fabric is, for example, polyester such as polyethylene terephthalate, polytrimethylene phthalate, polybutylene phthalate, polyamide such as nylon, nylon 6, nylon 11, nylon 12, nylon 66, polyolefin such as polyethylene and polypropylene, polyurethane and polychloride. Vinyl, acrylonitrile, styrene-based elastomer and the like are used.

The blood treatment member 5 may have a predetermined thickness by stacking a plurality of non-woven fabrics having the same fiber diameter, or may have a predetermined thickness by stacking a plurality of non-woven fabrics having different fiber diameters.
In the latter case, for example, as described in Patent No. 3710384 (Claims, paragraph [0015]), a prefilter (A) having an average fiber diameter D of 5.0 μm or more and 10.0 μm or less and an average fiber. The first filter (B) having a diameter D of more than 1.0 μm and 5.0 μm or less and an average fiber diameter D of 1. Includes three types of filters of the second main filter (C) of 5 μm or less.

The filters (A), (B), and (C) are laminated in the order of (A), (B), and (C) from the blood inlet to the blood outlet and from the upper U side to the lower D side. Therefore, as shown in FIG. 4, it can be arranged in the housing 2 having a blood inlet and a blood outlet.
For example, the pre-filter (A) has a stacking number of 15 to 25 and a thickness of 2.1 to 4. 2 mm, the first filter (B) has 20 to 35 layers and a thickness of 2.0 to 5. The 1 mm and the second filter (C) have a stacking number of 5 to 15 and a thickness of 0. 5 to 1.5 mm, etc.

[Material of housing 2 and outer frame sheet 3]
The material of the housing 2 and the outer frame sheet 3 is a soft member made of a thermoplastic resin, for example, soft polyvinyl chloride, polyurethane, styrene-butadiene-styrene copolymer, styrene-ethylene-butylene-styrene copolymer and mainly these. Thermoplastic agent elastomer as a component, styrene-butadiene-styrene copolymer hydrogenated product, styrene-isoprene-styrene copolymer or its hydrogenated product and other thermoplastic elastomer, thermoplastic elastomer and polyolefin, ethylene-ethyl acrylate Mixtures with softeners such as, ethylene-vinyl acetate copolymers are listed.
[Blood inlet 7I, blood outlet 7O, spacer T material]
A material that can be fixed to the housing 2 and the outer frame sheet 3 by heat sealing is preferable. For example, when the material of the housing 2 and the outer frame sheet 3 is soft polyvinyl chloride, the materials of the blood inlet 7I, the blood outlet 7O, and the spacer T. Is preferably semi-hard or hard polyvinyl chloride.

As the blood processor of Example 1, the one manufactured as described in the above paragraphs [0022] to [0027] was used.
As the blood treatment member 5, 60 sheets of polyethylene terephthalate non-woven fabric (thickness 130 μm, fiber diameter 1.8 μm, side length 66 mm × 66 mm) were used.
The spacers T used were substantially linear and had an outer diameter of 5 mm, and two spacers T were arranged between the inner wall of the lower housing 2 / D and the outer filtration portion 5 / O as shown in FIGS. 2 and 6.
A high-frequency welder was used to fix each member with a heat seal.
As the blood treatment device of Example 2, instead of the substantially linear spacers T (two) of Example 1, a spacer (two) having a substantially curved shape as shown in FIG. 7B was used. ..

As the blood treatment device of the comparative example, 60 sheets of polyethylene terephthalate non-woven fabric (thickness 130 μm, fiber diameter 1.8 μm, side length 72 mm × 72 mm) were used as the blood treatment member.
The blood processing unit was prepared as follows. The blood treatment member was fixed to the outer frame sheet, and the outer frame sheet was fixed to the flexible housing. The inside of the flexible housing is divided into a blood inflow chamber and a blood outflow chamber by sandwiching a blood processing member, the blood inlet is attached to the base end side of the blood inflow chamber, and the blood outlet is attached to the end side of the blood outflow chamber. did.
A high-frequency welder was used to fix each member with a heat seal.

A bag containing bovine blood [added ACD solution (60 ml) as an anticoagulant to bovine blood (400 ml)] and an empty bag were prepared.
Tubes are connected to the blood inlet and blood outlet of the blood treatment device housings of Examples 1 and 2 and Comparative Examples, respectively, a bag containing cow blood is connected to the upper end of the tube on the blood inlet side, and a bag containing cow blood is attached to the lower end of the tube on the blood outlet side. An empty bag was connected and the head from the top of the bag containing cow blood to the top of the empty bag (blood inlet) was set to 140 cm.
Cow blood was naturally dropped from the bag containing cow blood and filtered through the blood treatment member.

Examples 1 and 2 were prepared on different days, and a comparative test of filtration performance (blood filtration time) with the comparative example was conducted on different days.
The blood filtration time of "Example 1 and Comparative Example" carried out on July 7, 2016 was 45 minutes in Comparative Example, but the blood filtration was completed in 34 minutes in Example 1.
The blood filtration time of "Example 2 and Comparative Example" carried out on June 23, 2016 was 40 minutes in Comparative Example, but the blood filtration was completed in 36 minutes in Example 1. there were.
The filtration time of Comparative Examples differs between "Example 1 and Comparative Example" and "Example 2 and Comparative Example" because the properties of bovine blood differ depending on the blood collection date (especially in the summer when the temperature and humidity are high). This is because it is not constant.

From the above, in Examples 1 and 2, even if the blood outflow chamber 2RO becomes negative pressure during blood filtration, the blood flow path in the blood outflow chamber 2RO can be secured wider than in the comparative example, and the blood filtration time can be shortened. It could be confirmed.
The reason why the filtration time of Example 1 is relatively shorter than that of Comparative Example is that in Example 1, the terminal DE side of the spacer T is set to the fixed portion (terminal side) of the blood outlet 7O as compared to Example 2. Because it is fixed at a position close to the seal part 2SDE) (fixed part 2TS),
Alternatively, since the opening (7OO) of the blood outlet (7) is arranged deeper on the proximal end (PE) side than the fixed portion (2TS) on the terminal (DE) side of the spacer (T), the blood outlet 7O It is considered that the blood flow path can be widely secured in the region A near the opening 7OO.

1 Blood processor 2 (Flexible) Housing 2 / U Upper side (1st) Housing 2 / D Lower side (2nd) Housing SH Sheet SH / U Upper sheet SH / D Lower sheet T Spacer 2IR Blood inflow Room 2OR Blood outflow room 2S Housing seal (hypotenuse seal)
2TS spacer seal part (fixed part)
2SPE base end side seal part 2SDE end side seal part 3 outer frame sheet 3L extension part 3L / U upper side (first) extension part 3L / D lower side (second) extension part 3 / U upper side (first) outside Frame sheet 3 / D Lower side (2nd) Outer frame sheet 3S Outer frame seal part 3S / U Upper side (1st) Outer frame seal part 3S / D Lower side (2nd) Outer frame seal part 5 Blood treatment member 5S Seal 5F Filter 5FI Inner filter 5FO Outer filter 7I Blood inlet 7IO Opening 7O Blood outlet 7OI Insert 7OO Opening 8 Side hole CR Corner SCR Corner seal DE End PE Base end S1 First side S2 Second side Part U Upper D Lower 101 Blood treatment device 102 (Flexible) Housing 102 / U 1st housing 102 / D 2nd housing T spacer 102IR Blood inflow chamber 102OR Blood outflow chamber 102S Housing seal 103 Outer frame sheet 103 / U 1 Outer frame sheet 103 / D Second outer frame sheet 105 Blood processing member 105S Seal part 107I Blood inlet 107O Blood outlet 107OO Opening PF Pre-filter OP Opening SH sheet

Claims (4)

A first housing and a second housing formed of a flexible sheet,
The first housing and the blood processing member arranged in the second housing are provided.
The blood processing member is
An inner filtration section located on the first housing side and partitioning the blood inflow chamber together with the inner surface of the first housing.
It is located on the side of the second housing and has an outer filtration section that partitions the blood outflow chamber together with the inner surface of the second housing.
Further provided with a spacer which is arranged in the blood outflow chamber and regulates the deformation of the second housing toward the outer filtration portion.
The spacer is
It is arranged between the inner wall of the second housing and the outer filtration portion in the blood outflow chamber so as to extend from the blood inlet side to the blood inflow chamber to the blood outlet side of the blood outflow chamber . A substantially tubular outflow chamber spacer fixed to the second housing at each end on the inlet side and the outlet side ,
With a tubular member having a blood outlet communicated with the blood outflow chamber,
The tubular member is inserted into the blood outflow chamber, and a communication port of the tubular member with the blood outflow chamber is located on the inlet side of blood with respect to the outlet side end of the outflow chamber spacer . .. The blood processor according to claim 1 , wherein a plurality of outflow chamber spacers are arranged apart from each other so as to be substantially symmetrical with respect to a predetermined reference line. 1. Claim 1 further comprising a substantially tubular inflow chamber spacer arranged between the inner wall of the first housing and the inner filtration portion in the blood inflow chamber and fixed to the first housing at one end and the other end. Or the blood processor according to 2. The blood processor according to claim 3 , wherein a plurality of the inflow chamber spacers are arranged apart from each other so as to be substantially symmetrical with respect to a predetermined reference line.