JP2017196202A - Blood processor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood processing device capable of improving a blood flow by sufficiently securing (at a wide space BSP) a space near a blood inlet 7I of an inlet-side sheet 2I and near a blood outlet 7O of an outlet-side sheet 2O.SOLUTION: A plurality of nonwoven fabrics are superposed into a prescribed thickness, and a seal part (5S) is formed inward an outermost edge part (5OO) of the nonwoven fabric to delimit an inside part (5I) and an outer edge part (5O) by the seal part (5S). Further, an outer edge seal part (5OS) is formed on the outer edge part (5O), where the thickness (5OL) of the outer edge part (5O) is formed smaller than the thickness (5IL) of the inside part (5I).SELECTED DRAWING: Figure 1

Description

The present invention relates to a blood treatment device used for medical devices such as blood collection devices, blood dialysis, blood circuits used for blood purification, and the like.

The applicants disclosed in Patent Documents 1 and 2 an invention of a blood treatment device (leukocyte removal filter) in which a nonwoven fabric is loaded as a blood treatment member (blood filter) in a flexible housing.
Further, the applicant disclosed in Patent Document 3 an invention of a blood processing device (leukocyte removal filter) in which a plurality of non-woven fabrics are similarly stacked in a hard housing and loaded to a predetermined thickness.

Patent Document 4 discloses 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 blood chamber on the outflow side of a blood processing member (leukocyte removal filter member). The invention of a blood treatment device (leukocyte removal device) is disclosed in which the decrease in blood filtration rate is reduced and the adhesion of the housing is not poor.
In Patent Document 4, a sponge-like polyurethane porous body is used as a blood treatment member, the number of the porous bodies to be stacked is 6 (at most 10), and the outermost frame of the blood treatment member is an outer frame. And is fixed to the flexible housing.
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 in the flexible housing, and blood circulation at the peripheral edge in the flexible housing is improved. Residual blood in the department is prevented.
In Patent Document 5, a non-woven fabric is fixed to a flexible housing with an inner seal portion (first seal portion) and an outer seal portion (second seal portion) without using the outer frame sheet, and more than the inner seal portion. An invention in which a blood inlet (upper side) and a blood outlet (lower side) are mounted inside is disclosed.

Patent No. 3014916 (Claims, FIGS. 1 to 10) Japanese Patent No. 3049182 (Claims, FIGS. 1 to 6) Japanese Patent No. 3710384 (Claims, paragraph [0015]) Japanese Patent No. 3758853 (Claims, paragraphs [0038] to [0039], [0043], [0045], [0046], FIGS. 1 to 10) Patent No. 4038547 (Claims, FIGS. 2 and 3)

When a non-woven fabric is used as a blood treatment member as in Patent Document 3, and the number of the non-woven fabrics is increased and the thickness is increased and fixed to a flexible housing, the comparative example of FIGS. Like the blood processing device 51, the inner side of the outermost edge 55 </ b> OO of the blood processing member 55 is sealed (in the figure, reference numeral 55 </ b> S is a sealing portion) and is fixed (welded) to the housing 52 via the outer frame sheet 53. .
For this reason, as shown in FIG. 11B, the thickness 55OL of the outer edge portion 55O of the blood processing member 55 is substantially the same as or slightly larger than the thickness 55IL of the inner portion 55I. A space NSP in the vicinity of the blood inlet 57I of 52I and in the vicinity of the blood outlet 57O of the outlet side sheet 52O becomes a narrow space NSP (in FIG. 12, exaggerated for easy understanding of this state). It goes bad and eventually blood remains.

Moreover, since the invention of patent document 5 has to make a hole in each of the blood inlet side sheet and the blood outlet side sheet of the flexible housing and attach the blood inlet and blood outlet, compared with patent document 4 Processing becomes difficult.

Therefore, as a result of intensive studies in order to solve the above problems, the present inventors have reached the following invention.
[1] In the present invention, a plurality of non-woven fabrics are stacked in a predetermined thickness, and a seal portion (5S) is formed inside the outermost edge portion (5OO) of the non-woven fabric, and the seal portion (5S) To divide into the inner (5I) and outer edge (5O),
Forming an outer edge seal portion (5OS) on the outer edge portion (5O);
The blood processing member (5) formed so that the thickness (5OL) of the outer edge (5O) is smaller than the thickness (5IL) of the inner (5I) is provided.
[2] The blood processing member according to [1], wherein the thickness (5OL) of the outer edge portion (5O) is 30 or more and 70 or less with respect to the inner (5I) thickness (5IL): 100. (5) is provided.
[3] In the present invention, at least the outer edge seal portion (5OS) is formed at two or more locations on the outer edge portion (5O) in one side of the side portion, or at least the outer edge seal portion (5OS) is at the two or more outer edges. In addition to the seal part (5OS), [1] or [2] formed in one direction corner part (CR) of the side part (S) and one side corner part (CR) of the other side part (S) The blood processing member (5) described in the above.
[4] In the present invention, the shape of the blood treatment member (5) and the outer edge seal portion (5OS) includes a shape including a substantially straight portion and a corner portion (CR) or a curved portion as seen from the upper (U) side. The blood processing member (5) according to any one of [1] to [3] is provided.
[5] The blood treatment member (5) according to any one of [1] to [4], wherein the blood treatment member (5) and the outer edge seal portion (5OS) are formed in the same form or different forms. )I will provide a.

[6] The present invention provides a rectangular or substantially elliptical outer edge seal portion (5OS) such that the tangent line of the substantially linear portion or curved portion of the seal portion (5S) intersects approximately 90 ° to approximately 70 °, respectively. 2 or more, and the blood processing member (5) according to any one of [1] to [5], wherein the distance between the outer edge seal portions (5OS) is formed at substantially equal intervals. provide.
[7] In the present invention, the outer edge seal portion (5OS) is formed at least in the region of the outer edge portion (5O),
From either one of the inner edge portion (5SI) of the seal portion (5S) or the region of the seal portion (5S), the outer edge portion (5SO) of the seal portion (5S), or the outer edge portion (5O). Formed up to the outermost edge (5OO), or from the area of the outer edge (5O) to the outer edge (5SO) of the seal part (5S), or within the area of the seal part (5S) or the inner edge of the seal part (5S) The blood processing member (5) according to any one of [1] to [6], which is formed up to any one of (5SI).
[8] When the present invention is viewed from the upper (U) side and rotated from one direction of the side portion (S) to one direction of the other side portion (S) at a predetermined angle θ, the seal portion ( 5S) and the outer edge seal portion (5SO) provide the blood processing member (5) according to any one of [1] to [7] formed so as to substantially overlap.

[9] The present invention includes a flexible housing (2) and the blood processing member (5) according to any one of [1] to [8] loaded in the housing (2). ,
The housing (2) is composed of an inlet side sheet (2I) and an outlet side sheet (2O),
With the blood treatment member (5), the housing (2) is arranged to partition into a blood inflow chamber (2IR) and a blood outflow chamber (2OR),
The housing (2) has a blood inlet (7I) communicating with the blood inflow chamber (2IR) on the base end (PE) side, and blood communicating with the blood outflow chamber (2OR) on the end (DE) side. A blood processor (1) equipped with an outlet (70) is provided.
[10] The present invention provides a flexible housing comprising the blood processing member (5) according to any one of [1] to [8], comprising an inlet side sheet (2I) and an outlet side sheet (2O). By directly fixing to (2), the blood processor (1) according to [9] is provided in which the housing (2) is partitioned into a blood inflow chamber (2IR) and a blood outflow chamber (2OR).
[11] The present invention provides a flexible housing by fixing the blood processing member (5) according to any one of [1] to [8] to an outer frame sheet (3) or a tubular member. The blood processor (1) according to [9], wherein (2) is partitioned into a blood inflow chamber (2IR) and a blood outflow chamber (2OR).
[12] In the present invention, the blood inlet (7I) on the proximal end (PE) side is formed from the upper side (U) side toward the lower side (D) side, from the inlet side sheet (2I) / blood inlet ( 7I) / the outer frame sheet (3) to which the blood processing member (5) is fixed or the tubular member or the blood processing member (5) / the outlet side sheet (2O) in this order,
The place where the blood outlet (70) on the terminal (DE) side is formed is an outer frame in which the inlet side sheet (2I) / blood treatment member (5) is fixed from the upper (U) side to the lower (D) side. The blood treatment device according to any one of [9] to [11], wherein the sheet (3) or the tubular member or blood treatment member (5) / blood outlet (7O) / outlet side sheet (2O) is fixed in this order. Provide (1).
[13] In the present invention, the housing (2), the outer frame sheet (3), and the blood processing member (5) have a form including a substantially straight portion and a corner portion (CR), and the three members are in the same direction. Fixed to
The blood inlet (7I) and the blood outlet (70) are mounted so as to intersect the base (PE) side and the terminal (DE) side of the housing (2) and the outer frame sheet (3) substantially perpendicularly, The blood processing device (1) according to any one of [9] to [12], which is mounted substantially parallel to the first side (S1) side and the second side (S2) side.
[14] In the present invention, the housing (2), the outer frame sheet (3), and the blood processing member (5) have a form including a substantially straight portion and a corner portion (CR), and the three members are in the same direction. Fixed to
The blood inlet (7I) is attached to the corner (CR) on the base end (PE) side of the housing (2) and the outer frame sheet (3), and the blood inlet (70) is attached to the corner (CR) on the terminal (DE) side. The blood processing device (1) according to any one of [9] to [12] is provided.

(1) Since the thickness of the outer edge portion 5O of the blood processing member 5 can be reduced, a sufficient space (space) in the vicinity of the blood inlet 7I of the inlet side sheet 2I and in the vicinity of the blood outlet 7O of the outlet side sheet 2O is secured (wide). Space BSP) and blood flow can be improved.
(2) When the blood processing member 5 is rotated at a predetermined angle from one direction of the side portion to one direction of the other side portion when viewed from the upper U side, the seal portion 5S and the outer edge seal portion 5SO are substantially Even when the mounting positions of the blood inlet 7I and the blood outlet 7O in the housing 2 are changed, the blood processing member 5 is loaded into the housing 2 and used only by changing the direction. be able to.

FIG. 1 is an overall view (plan view / schematic diagram) of a blood processing apparatus 1 of the present invention. FIG. 2 is an overall view (plan view / schematic diagram) of the blood processing member 5. FIG. 3 is a side view (schematic diagram) of FIG. FIG. 4 is an overall view (plan view / schematic diagram) showing an example of a blood processing member (5.1, 5.2, 5.3, 5.4) of another embodiment. FIG. 5 is an exploded view of the blood processing device 1. FIG. 6 is an overall view (plan view / schematic diagram) showing an example of the blood processing device 1.1 of another embodiment. FIG. 7 is an overall view (plan view / schematic diagram) showing an example of a blood processing device 1.1 of another embodiment. FIG. 8 is a cross-sectional view (schematic diagram) along AA in FIG. FIG. 9 is an exploded view showing an example of the blood processing device 1.3 according to another embodiment. FIG. 10 is an overall view (plan view / schematic diagram) of a blood treatment device 51 of a comparative example. FIG. 11 is an overall view of a blood processing member 55 of a comparative example. (A) is (plan view / schematic diagram). (B) is a side view (schematic diagram) of (A). 12 is a cross-sectional view (schematic diagram) taken along line AA of FIG.

Hereinafter, the present invention will be described in detail with reference to the drawings.
Hereinafter, in order to clearly describe the blood processing apparatus 1 of the present invention, the following definitions are given with reference to the arrangement of the drawings.
The proximal end PE side (also referred to as direction, hereinafter the same) means, for example, the blood inlet 7I side as shown in FIG.
The terminal DE side means, for example, the blood outlet 7O side as shown in FIG.
The first side portion S1 side means a direction on the right side of a line connecting the blood inlet 7I and the blood outlet 70 in series as shown in FIG.
The second side portion S2 side means, for example, as shown in FIG. 1, the direction opposite to the first side portion S1 side, that is, the left side direction of the line connecting the blood inlet 7I and the blood outlet 70 in series.
The upper U side means, for example, a direction on the upper side of the page as shown in FIG.
In FIG. 1, it means the direction of the front side of the page.
The lower D side means, for example, the lower direction of the paper as shown in FIG.
In FIG. 1, it means the direction of the back side of the paper.
The proximal end PE side, the distal DE side, the first side portion S1, the second side portion S2, the upper portion U, and the lower portion U may be referred to as one direction of the side portion.
The terminal DE side opposite to the base 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 first side S1 and the second side S2, the upper U and the lower U.

In contrast to the blood processing device 1 of FIG. 1, the numbers after the decimal point of the blood processing device 1.1, the blood processing device 1.2, etc. of FIGS. 6 and 7 show other embodiments. The blood processing member 5 in FIG. 4 is the same as the blood processing member 5.1 in FIG. 4 and the supporting member 3.1 in FIG.
In addition, in order to prevent complication of the reference numerals, “Blood Treatment Device 1”, “Supporting Member 3”, “Blood Processing” are simply included in the “claims” and “means for solving the problems” columns and part of the description of the invention. Although described as “Member 5”, these also include the blood treatment devices 1.1 and 1.2, the support member 3.1, and the blood treatment members 5.1, 5.2, 5.3, and 5.4. In addition, members that are common in the description and drawings of each embodiment are similarly denoted by the same reference numerals to prevent complication of the reference numerals. In the drawings, some reference numerals are omitted.

As shown in FIGS. 1, 2, and 8, the blood processing device 1 of the present invention includes a flexible housing 2 (hereinafter simply referred to as a housing 2) and a blood processing member 5 loaded in the housing 2. Have
The housing 2 includes an inlet side sheet 2I and an outlet side sheet 2O.
The blood processing member 5 is disposed so as to partition the housing 2 into a blood inflow chamber 2IR and a blood outflow chamber 2OR.
A blood inlet 7I communicating with the blood inflow chamber 2IR is attached to the base end PE side of the housing 2, and a blood outlet 7O communicating with the blood outflow chamber 2OR is attached to the terminal DE side of the housing 2. .

The blood processing member 5 is directly fixed to the peripheral edge of the outer frame sheet 3 made of a thermoplastic resin soft member. Or it can be indirectly fixed using other weldable members.
For example, as shown in FIGS. 1, 5, and 8, the blood treatment device 1 is located on the proximal end PE side, and the place where the blood inlet 7 </ b> I is attached is the inlet side sheet 2 </ b> I / The blood inlet 7I / outer frame sheet 3 / outlet side sheet 2O are fixed in this order.
The outer edge portion 5O on the base end PE side of the blood processing member 5 is fixed to the inner edge portion of the outer frame sheet 3 on the lower portion D side.
Further, in the blood processing device 1, on the terminal DE side, the place where the blood outlet 7O is attached is the inlet side sheet 2I / outer frame sheet 3 / blood outlet 7O / outlet side sheet 2O from the upper U side toward the lower D side. They are fixed in order.
The outer edge portion 5O on the terminal DE side of the blood processing member 5 is fixed to the inner edge portion of the outer frame sheet 3 on the upper U side.

These fixations can be performed by welding by external heating by heat sealing, high frequency, internal heating by ultrasonic waves, or the like.
Each of the members, for example, the inlet side sheet 2I / blood inlet 7I / outer frame sheet 3 (blood processing member 5) / outlet side sheet 2O may be welded at the same time, or two or more members, for example, the inlet side sheet 2I. / Blood inlet 7I and outer frame sheet 3 (blood treatment member 5) / outlet side sheet 2O may be welded.
Further, instead of the outer frame sheet 3, a tubular member (corresponding to “mouth welded portions 6 and 7” described in Patent Document 1) may be used and fixed.
Further, without using the outer frame sheet 3, tubular member, the inlet side sheet 2I / blood inlet 7I / blood processing member 5 / outlet side sheet 2O on the proximal PE side, and the inlet side sheet 2I / blood processing member on the terminal DE side The blood processing member 5 may be directly fixed to the housing 2 (inlet side sheet 2I, outlet side sheet 2O) as in 5 / blood outlet 7O / outlet side sheet 2O. (See Japanese Patent No. 4186096)

FIG. 2 shows an example of the blood processing member 5.
The blood treatment member 5 has a plurality of non-woven fabrics stacked in a predetermined thickness, and forms a seal portion 5S inside the outermost edge portion 5OO of the non-woven fabric. The seal portion 5S allows the inner 5I and the outer edge portion to be formed. It is divided into 5O.
An outer edge seal portion 5OS is formed in the outer edge portion 5O, and the thickness 5OL of the outer edge portion 5O is formed to be smaller than the thickness 5IL of the inner 5I.
4A, 4B, 4C, and 4D show examples of other blood processing members 5.1, 5.2, 5.3, and 5.4.
In FIGS. 2, 4A, and 4B, the shape of the blood processing member 5 and the seal portion 5S is formed in a substantially square shape when viewed from the upper U direction. Elongate from the end PE to the terminal DE direction, also referred to as a substantially square shape), a substantially circular shape as shown in FIG. 4C, a substantially regular hexagonal shape as shown in FIG. May be formed to be elongated in the terminal DE direction.
The shape of the blood treatment member 5 and the seal portion 5S is a so-called curved shape such as a shape having a so-called substantially straight portion and a corner portion such as a substantially square shape, a substantially rectangular shape, a substantially quadrangular shape, a substantially regular hexagonal shape, or a circular shape or a substantially oval shape. You may form in the form which has a part.
In order to effectively secure the filtration area of the blood treatment member 5 (nonwoven fabric), the blood treatment member 5 and the seal portion 5S are preferably formed in the same shape, but different shapes may be combined. For example,
Blood processing member 5 (substantially circular) / seal part 5S (substantially square), blood processing member 5 (substantially square) / seal part 5S (substantially circular), or blood processing member 5 (substantially oval) / seal part 5S (rectangular) ), Or a combination of different shapes such as blood processing member 5 (rectangular) / seal portion 5S (substantially oval).

In FIG. 2, the outer edge seal portion 5OS is formed in a rectangular shape (a seal portion 5S on one side, which is shorter than the substantially straight portion, so-called substantially linear shape), but the thickness 5OL of the outer edge portion 5O is the inner 5I. Any shape can be used as long as the thickness can be smaller than 5IL. For example, a substantially square shape as shown in FIG. 4A, a substantially circular shape as shown in FIG.
The number and arrangement (position) of the outer edge seal portion 5OS in FIG. 2 are substantially straight portions of the four-direction seal portions 5S on the terminal DE side, the base end PE side, the first side portion S1 side, and the second side portion S2 side. In addition, three points are formed at substantially equal intervals so as to cross each other substantially perpendicularly (crossing angle θ = approximately 90 °), and further, from the inner edge portion 5SI of the seal portion 5S to the outermost edge portion 5OO of the outer edge portion 5O. However, any number and arrangement (position) can be used as long as the thickness 5OL of the outer edge 5O can be smaller than the thickness 5IL of the inner 5I.
For example, when 5IL is 100, 5OL is formed from 70 or less to 30 or more, preferably from 60 or less to 40 or more. If 5OL is too large (exceeds 70), a sufficient space (space) cannot be secured in the vicinity of blood inlet 7I (blood outlet 7O). Conversely, if it is too small (less than 30), it takes time to weld. In addition, too much pressure is applied to the nonwoven fabric, causing damage.

The number / shape per side of the outer edge seal portion 5OS / (only in the case of a rectangle or a substantially oval shape) the intersecting angle / formation range with the seal portion 5S in FIG.
Number (3 locations / per side) / shape (rectangular) / intersection angle (substantially vertical: substantially 90 °) / range (inner edge 5SI of seal part 5S to outermost edge part 5OO of outer edge part 5O) But for example
As shown in FIG. 4 (A), the number (2 locations / per side) / shape (substantially square) / range (from the inner edge 5SI of the seal portion 5S to the outermost edge 5OO of the outer edge 5O), or FIG. As shown in B), the number (2 locations / per side) / shape (substantially circular) / range (the inner edge 5SI of the seal portion 5S to the outermost edge 5OO of the outer edge 5O) or the number (3 locations / 1) Per side) / shape (substantially oval) / range (not reaching the outermost edge 5OO in the middle of the outer edge 5O from the outer edge 5SO of the seal portion 5S) or number (3 locations / per side) / shape ( (Rectangular) / intersection angle (approximately 80 degrees) / range (from the inner edge 5SI of the seal portion 5S to the outermost edge 5OO of the outer edge 5O).

As shown in FIGS. 2 and 4D, the crossing angle between the outer edge seal portion 5OS (rectangular and substantially oval) and the substantially straight portion of the seal portion 5S is preferably substantially vertical (approximately 90 °), but is approximately 70. It should be at least °. If it is too small (less than about 70 °) (for example, when the blood processing member 5 has a substantially square shape), it becomes difficult to form the thickness 5OL of the outer edge portion 5O uniformly.
As shown in FIG. 4C, the intersection angle between the circular seal portion 5S and the outer edge seal portion 5OS (rectangular, substantially elliptical) is an angle at which the circular tangent line and the outer edge seal portion 5OS intersect.
As shown in FIG. 4D, the crossing angle between the seal portion 5S having a substantially regular hexagonal corner portion and the outer edge seal portion 5OS (rectangular or substantially oval) is the distal side DE (base end PE) of the seal portion 5S. It is preferable to form it substantially in parallel with the substantially straight portion.

The outer edge seal portion 5OS is preferably formed continuously from the inner edge portion 5SI of the seal portion 5S to the outermost edge portion 5OO of the outer edge portion 5O, but the thickness 5OL of the outer edge portion 5O is larger than the thickness 5IL of the inner portion 5I. If it can be made smaller, it may be formed at least in the region of the outer edge portion 5O.
Further, the inner edge portion 5SI of the seal portion 5S or the region of the seal portion 5S or the outer edge portion 5SO of the seal portion 5S or the region of the outer edge portion 5O may be formed from one place to the outermost edge portion 5OO.
Further, it may be formed from the region of the outer edge portion 5O to the outer edge portion 5SO of the seal portion 5S or the region of the seal portion 5S or the inner edge portion 5SI of the seal portion 5S.

By forming the outer edge seal portion 5OS as described above, the thickness 5OL of the outer edge portion 5O can be suppressed smaller than the thickness 5IL of the inner portion 5I, for example, as shown in FIG.
As a result, as shown in FIG. 8, a sufficient space (space) in the vicinity of the blood inlet 7I of the inlet side sheet 2I and in the vicinity of the blood outlet 7O of the outlet side sheet 2O can be secured (wide space BSP). Can be improved. (FIG. 8 is exaggerated for easy understanding of this state.)

FIG. 6 shows a blood processing device 1.1 of another embodiment.
The housing 2, the outer frame sheet 3, and the blood processing member 5 of the blood processing device 1 of FIG. 1 have a substantially square shape, and these three members are fixed in the same direction.
Each of the three members has four sides (base end PE side, terminal DE side, first side S1 side, second side S2 side) and a corner portion CR therebetween.
The blood inlet 7I and the blood outlet 70 are mounted so as to intersect the base 2 PE side and the terminal DE side of the housing 2 and the outer frame sheet 3 substantially perpendicularly, and the housing 2 and the first side part of the outer frame sheet 3 It is mounted substantially parallel to the sides on the S1 side and the second side S2 side.

In the blood processing device 1.1 of FIG. 6, the housing 2, the outer frame sheet 3, and the blood processing member 5 are rotated approximately 45 degrees toward the first side S1 or the second side S2.
In FIG. 6, the four sides are from the base PE side to the first side S1 side, from the base PE side to the second side S2 side, from the second side S2 side to the terminal DE side. And a side that rises from the first side S1 side to the terminal DE side.
The blood inlet 7I and the blood outlet 70 are attached to the corner portion CR of the housing 2 and the outer frame sheet 3.
More specifically, the blood inlet 7I is attached to the corner portion CR on the base end PE side of the housing 2 and the outer frame sheet 3, and the blood inlet 7O is attached to the corner portion CR on the terminal DE side. The first side portion S1 and the second side portion S2 are also corner portions CR.

The blood processing device 1.2 of FIG. 7 is further added to the blood processing member 5 of FIG. The blood processing member 5.5 formed with the outer edge seal portion 5SO is used.
That is, the outer edge seal portion 5SO is formed in the vicinity of the blood inlet 7I and the blood outlet 7O in the blood processing device 1.2, so that this portion becomes a more concave portion. In other words, the thickness 5OL of the outer edge portion 5O becomes smaller.
Therefore, blood easily flows in the vicinity of the blood inlet 7I, and the blood processed (filtered) by the blood processing member 5.5 can be quickly discharged from the blood outlet 7O in the vicinity of the blood outlet 70.
The outer edge seal portion 5SO of the corner portion CR is preferably wide (in other words, larger in area) than the outer edge seal portion 5SO formed in a substantially straight portion.

The blood processing member 5 has a predetermined angle θ from one direction of the side part to one direction of the other side part.
(Θ is approximately 30 °, 45 °, 60 °, 90 °, 180 °) by rotating, for example, even when the attachment positions of the blood inlet 7I and the blood outlet 7O to the housing 2 are changed as shown in FIG. The blood processing member 5 can be used by being loaded into the housing 2 only by changing the direction.
For example, the blood processing members 5, 5.1, and 5.2 in FIGS. 2, 4A, and 4B are viewed from one side of the side to one direction of the other side as viewed from the upper U side. When the blood processing member 5.3 in FIG. 4C is rotated by approximately 60 ° and the blood processing member 5.4 in FIG. 4D is rotated by approximately 180 °, the seal portion 5S and the outer edge seal are rotated. The part 5SO is formed so as to substantially overlap.

In the blood treatment device 1 of FIG. 1, the combination of the housing 2, the outer frame sheet 3, and the blood treatment member 5 as viewed from the upper U direction is the housing 2 (substantially square), the outer frame sheet 3 (substantially square), and blood. Although it is set as the processing member 5 (substantially square),
The housing 2 and the outer frame sheet 3 also adopt the form including the substantially straight part and the corner part or the form including the curved part, and the housing 2.1 (2.1I, 2.1O) (substantially circular), outer frame sheet 3.1 (substantially circular) and blood processing member 5.3 (substantially circular), or
Housing 2 (substantially circular), outer frame sheet 3 (substantially square) and blood processing member 5 (substantially square), or
You may form like the housing 2 (substantially square), the outer frame sheet | seat 3 (substantially circular), and the blood processing member 5 (substantially circular).

[Blood processing parts]
The constituent material of the blood processing member 5 uses a non-woven fabric as described above.
Nonwoven fabric materials include, for example, polyesters such as polyethylene terephthalate, polytrimethylene phthalate, and polybutylene phthalate, polyamides such as nylon, nylon 6, nylon 11, nylon 12, and nylon 66, polyolefins such as polyethylene and polypropylene, polyurethane, polychlorinated Vinyl, acrylonitrile, styrene elastomer, etc. 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 Document 3, a prefilter (A) having an average fiber diameter D of 5.0 μm to 10.0 μm, and an average fiber diameter D of more than 1.0 μm and 5.0 μm The following first main filter (B) and average fiber diameter D are 1. It includes three types of filters, 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. Thus, as shown in FIG. 8, it can be arranged in a housing 2 having a blood inlet and a blood outlet.
For example, the pre-filter (A) has a stack number of 15 to 25 and a thickness of 2.1 to 4. The first main filter (B) has a thickness of 20 to 35 and a thickness of 2.0 to 5 mm. 1 mm and the second main filter (C) have 5 to 15 stacked sheets and a thickness of 0. 5 to 1.5 mm or the like.

[Material of housing 2, outer frame sheet]
The material of the housing 2 and the outer frame sheet 3 is a soft member made of thermoplastic resin, such as soft polyvinyl chloride, polyurethane, styrene-butadiene-styrene copolymer, styrene-ethylene-butylene-styrene copolymer, and these. Thermoplastic elastomer as component, hydrogenated product of styrene-butadiene-styrene copolymer, thermoplastic elastomer such as styrene-isoprene-styrene copolymer or hydrogenated product, thermoplastic elastomer and polyolefin, ethylene-ethyl acrylate And a mixture with a softening agent such as ethylene-vinyl acetate copolymer.

As a material of the blood treatment member 5, 40 sheets of polyethylene terephthalate non-woven fabric (thickness 130 μm, fiber diameter 1.8 μm, side length 95 mm) are stacked, and a high-frequency welder is used to seal the seal portion 5S and the outer edge seal. Part 5OS was formed, and blood processing member 5 shown in FIG. 2 was produced.
The blood processing member 5 is fixed to the outer frame sheet 3 as shown in FIG. 6 using a high frequency welding machine, and the outer frame sheet 3 is blood inlet 7I, inlet side housing 2I, blood outlet as shown in FIG. Together with 7O and the outlet-side housing 2O, it was fixed using a high-frequency welder, and a blood processing device 1.1 (Example) in FIG. 6 was produced.
A blood treatment device of a comparative example was produced in the same manner as in the above example except that the outer edge seal portion 5OS was not formed with respect to the blood treatment member 5 of the above example.

A bag containing bovine blood [added ACD solution (60 ml) as an anticoagulant to bovine blood (400 ml)] and an empty bag were prepared.
Connect the tubes to the blood inlet and blood outlet of the housing of the blood processor of the example and the comparative example, respectively, connect the bovine blood bag to the upper end of the tube on the blood inlet side, and connect the empty bag to the lower end of the tube on the blood outlet side The drop from the upper part of the bag containing bovine blood to the upper part of the empty bag (blood inlet) was set to 140 cm.
The bovine blood was naturally dropped from the bag containing bovine blood and filtered with the blood treatment member.
In the blood processing device of the comparative example, residual blood was observed, but in the blood processing device 1.1 of the example, it was confirmed that there was no residual blood and the blood flow was improved satisfactorily.

1, 1.1, 1.2, 1.3 Blood processor 2, 2.1 Flexible housing 2I, 2.1I Inlet side sheet 2O, 2.1O Outlet side sheet 2IR Blood inflow chamber 2OR Blood outflow chamber 3 3.1 Outer frame sheet 5 Blood processing member 5.1 Blood processing member 5.2 Blood processing member 5.3 Blood processing member 5.4 Blood processing member 5.5 Blood processing member 5I Internal 5S Seal portion 5SI Inner edge 5SO Outer edge portion 5O Outer edge portion 5OO Outermost edge portion 5OS Outer edge seal portion 7I Blood inlet 7O Blood outlet CR Corner portion BSP Wide space NSP Narrow space DE Terminal PE Base end S1 First side portion S2 Second side portion U Upper portion D Lower portion

Claims (14)

A plurality of non-woven fabrics are stacked in a predetermined thickness, and a seal portion (5S) is formed on the inner side of the outermost edge portion (5OO) of the non-woven fabric. Comparting the outer edge (50)
Forming an outer edge seal portion (5OS) on the outer edge portion (5O);
A thickness (5OL) of the outer edge (5O) was formed to be smaller than a thickness (5IL) of the inner (5I).
A blood processing member (5) characterized by the above. The inner edge (5I) has a thickness (5IL) of 100, and the outer edge portion (5O) has a thickness (5OL) of 30 to 70,
The blood processing member (5) according to claim 1, wherein the blood processing member (5) is provided. At least the outer edge seal portion (5OS) is formed at two or more locations on the outer edge portion (5O) in one direction of the side portion, or at least the outer edge seal portion (5OS) is added to the two or more outer edge seal portions (5OS). The unidirectional corner portion (CR) of the side portion (S) and the unidirectional corner portion (CR) of the other side portion (S) are formed.
The blood processing member (5) according to claim 1 or 2, characterized by the above. The form of the blood treatment member (5) and the outer edge seal part (5OS) is a form including a substantially straight part and a corner part (CR) or a form including a curved part when viewed from the upper (U) side. The blood processing member (5) according to any one of claims 1 to 3. The blood processing member (5) according to any one of claims 1 to 4, wherein the blood processing member (5) and the outer edge seal portion (5OS) are formed in the same form or in different forms. Two or more rectangular or substantially elliptical outer edge seal portions (5OS) are formed on the tangent line of the substantially straight line portion or the curve portion of the seal portion (5S) so as to intersect from approximately 90 ° to approximately 70 °, respectively. The distance between the outer edge seal portions (5OS) was formed at substantially equal intervals.
The blood processing member (5) according to any one of claims 1 to 5, characterized in that: The outer edge seal portion (5OS) is formed at least in the region of the outer edge portion (5O),
From either one of the inner edge part (5SI) of the seal part (5S), the area of the seal part (5S), the outer edge part (5SO) of the seal part (5S), or the area of the outer edge part (5O) Formed up to the outermost edge (5OO), or from the area of the outer edge (5O) to the outer edge (5SO) of the seal part (5S), or within the area of the seal part (5S) or the inner edge of the seal part (5S) (5SI) up to any one place,
The blood processing member (5) according to any one of claims 1 to 6, wherein the blood processing member (5) is provided. When viewed from the upper (U) side, when rotated at a predetermined angle θ from one direction of the side part (S) to one direction of the other side part (S), the seal part (5S) and the outer edge seal part ( 5SO) was formed to substantially overlap,
The blood processing member (5) according to any one of claims 1 to 7, wherein the blood processing member (5) is provided. A blood treatment member (5) according to any one of claims 1 to 8, wherein the blood treatment member (5) is loaded into the flexible housing (2) and the housing (2).
The housing (2) is composed of an inlet side sheet (2I) and an outlet side sheet (2O),
With the blood treatment member (5), the housing (2) is arranged to partition into a blood inflow chamber (2IR) and a blood outflow chamber (2OR),
The housing (2) has a blood inlet (7I) communicating with the blood inflow chamber (2IR) on the base end (PE) side, and blood communicating with the blood outflow chamber (2OR) on the end (DE) side. Equipped with outlet (70),
The blood processing device (1) characterized by the above. The blood processing member (5) according to any one of claims 1 to 8 is directly fixed to a flexible housing (2) comprising an inlet side sheet (2I) and an outlet side sheet (2O). The blood processing device (1) according to claim 9, wherein the housing (2) is partitioned into a blood inflow chamber (2IR) and a blood outflow chamber (2OR). The blood treatment member (5) according to any one of claims 1 to 8 is fixed to the outer frame sheet (3) or the tubular member, whereby the flexible housing (2) is placed in the blood inflow chamber. The blood processing device (1) according to claim 9, wherein the blood processing device (1) is divided into (2IR) and a blood outflow chamber (2OR). The position where the blood inlet (7I) on the base end (PE) side is formed is from the upper (U) side toward the lower (D) side, from the inlet side sheet (2I) / blood inlet (7I) / blood processing member ( 5) fixed to the outer frame sheet (3) or the tubular member or blood processing member (5) / outlet side sheet (2O) in this order,
The place where the blood outlet (70) on the terminal (DE) side is formed is an outer frame in which the inlet side sheet (2I) / blood treatment member (5) is fixed from the upper (U) side to the lower (D) side. Fixed in the order of the sheet (3) or tubular member or blood treatment member (5) / blood outlet (70) / outlet side sheet (20),
The blood processing device (1) according to any one of claims 9 to 11, wherein the blood processing device (1) is provided. The housing (2), the outer frame sheet (3), and the blood processing member (5) have a form including a substantially straight portion and a corner portion (CR), and the three members are fixed in the same direction.
The blood inlet (7I) and the blood outlet (70) are mounted so as to intersect the base (PE) side and the terminal (DE) side of the housing (2) and the outer frame sheet (3) substantially perpendicularly, The first side part (S1) side and the second side part (S2) side are mounted substantially parallel to the sides,
The blood processing device (1) according to any one of claims 9 to 12, characterized in that: The housing (2), the outer frame sheet (3), and the blood processing member (5) have a form including a substantially straight portion and a corner portion (CR), and the three members are fixed in the same direction.
The blood inlet (7I) is attached to the corner (CR) on the base end (PE) side of the housing (2) and the outer frame sheet (3), and the blood inlet (70) is attached to the corner (CR) on the terminal (DE) side. The blood processing device (1) according to any one of claims 9 to 12, wherein the blood processing device (1) is attached.