JPH04197266A - Blood treating device - Google Patents

Abstract

PURPOSE:To minimize the stagnation of blood in a blood inflow port even if a blood treatment is executed at a low flow rate and to allow the blood treatment without using an anticlotting agent by having a blood sending tube swiveling means which swivels a blood sending tube and forming the blood inflow port of the blood treating device so as to have a specific shape. CONSTITUTION:This device has the blood sending tube swiveling means 4 which swivels the blood sending tube 5. The blood inflow port 19 of the blood treating device 3 satisfies the conditions; 3 deg.<R<20 deg., 0.02<H/D<0.2, A/D<0.4 in the relation among the diameter D of a disk-shaped space 19c, thickness H thereof, the inside diameter A of the juncture between a flat part 19a and a cylindrical part 19b and the taper angle R of the cylindrical part 19b. The flow velocity distribution of the blood flowing in the blood inflow port 19 is changed by operating the swirling means 4. Further, the cylindrical part 19b has a tapered inside surface and the blood flowing into the inflow port 19 from the blood sending tube 5 in the swirling state passes the cylindrical part 19b and flows into the flat part 19a while the swirling state is maintained to some extent and, therefore, the velocity flow distribution of the blood is more surely changed.

Description

[Detailed description of the invention] [Industrial field of use: The present invention relates to a blood processing device.

Specifically, there are artificial lungs that circulate blood through blood processing members to perform gas exchange such as adding oxygen and removing carbon dioxide, artificial dialyzers that perform hemodialysis, plasma separators that separate blood components, The present invention relates to a blood processing device equipped with a blood processing device such as a blood purifier that performs adsorption and purification of blood.

[Prior Art] Conventionally, for example, a hollow fiber membrane oxygenator has been used as a blood processing device. The general structure of a hollow fiber membrane oxygenator is a cylindrical tube with an inlet and an outlet for oxygen-containing waste.
A hollow fiber membrane bundle consisting of a large number of hollow fiber membranes for gas exchange is inserted into the housing, and both ends of the hollow fiber membrane bundle are
The cylindrical housing is liquid-tightly fixed to both ends by partition walls formed with a botting agent.

Further, a funnel-shaped blood port is attached to the outside of each partition wall to form a blood inlet and a blood outlet.

In recent years, unlike conventional blood processing, blood processing methods that involve long-term extracorporeal circulation have been used. Specifically, extracorporeal assisted circulation (ECMO) using a deformed oxygenator has been used. ), continuous hemodialysis (CAVD) using an artificial dialyzer, continuous hemofiltration using a hemofilter (
CAVH).

When blood is circulated through such a blood processing device, an anticoagulant (for example, heparin) is added to the blood in order to prevent blood coagulation within the blood processing device. but,
The longer the blood treatment continues, the higher the dose of heparin will be, and the administration of heparin will reduce the blood coagulation ability of the patient undergoing blood treatment, resulting in delayed healing of other traumatic sites, surgical sites, etc. It turns out. For this reason, it is preferable to circulate blood with a smaller amount of heparin or to treat blood without administering heparin. However, inside the blood inflow port of the blood processing device (for example, an artificial lung), blood tends to stagnate, leading to the deposition of blood cells and even the formation of blood clots. Circulation is difficult. In addition, the blood inflow port functions as a chamber for allowing blood to flow into the hollow fiber of the blood processing device, and the blood inflow port functions as a connection with the blood supply tube, so it may simply be omitted. I can't bring it. Therefore, we improved the shape of the blood inflow port (
For example, Japanese Patent Publication No. 62-54510, Japanese Patent Publication No. 60-
No. 5308).

[Problems to be Solved by the Invention] However, the improvement in the shape of the blood inflow port as described above is insufficient to suppress partial retention inside the blood port. In blood processing performed at low flow rates, it is difficult to avoid partial stagnation inside the blood port, and there is an extremely high risk of thrombus formation within the blood port unless anticoagulants are used. Ta.

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to solve the above-mentioned problems, and even when blood treatment is performed at a low flow rate, there is very little blood stagnation in the blood inflow port, and blood treatment is performed without using an anticoagulant. The present invention provides a blood processing device that can perform the following steps.

[Means for Solving the Problems] The object of the present invention described above is achieved by a housing, a blood processing member inserted into the how/puffer, and both ends of the blood processing member inserted into the housing. partition walls fixed liquid-tightly to both ends of the housing, and partition walls provided near both ends of the housing, which connect one surface of the blood processing member to the housing/housing.
A blood processing fluid inlet and outlet communicating with the space formed by the inner surface of the pufferfish and the partition wall, a blood inlet port having the blood inlet attached to one end of the housing, and the other end of the housing a blood processing device having a blood outflow port having a blood outflow port attached to the blood inflow port; a blood feeding tube connected to the blood inflow port of the blood inflow port; and a feeding tube turning means for rotating the blood feeding tube. , the blood inflow port of the blood processing device includes a flat part forming a disc-shaped space facing the partition wall, and a flat part that projects outward from the center of the flat part and whose inner diameter is tapered toward the distal end. a cylindrical portion having a diameter-reduced portion, and further includes a diameter of the disc-shaped space, a thickness H of the disc-shaped space, and a connection between the flat part and the cylindrical part. The relationship between the inner diameter A of the part and the taper angle R of the cylindrical part is 3°<R<20°, 0.02<H/D<0.2, A/D
This blood processing device satisfies the condition of <0.4.

The cylindrical portion of the blood inflow port has a cylindrical portion that is continuous with the reduced diameter portion and has a substantially uniform inner diameter, and a connecting portion between the cylindrical portion and the cylindrical portion. The relationship between the inner diameter B and the length of the cylindrical portion is O≦L<
It is preferable that it is B. Preferably, the relationship between the length G of the reduced diameter portion of the cylindrical portion of the blood inflow port and the diameter of the disc-shaped space is 1/10-D<G<D. Preferably, the cylindrical portion of the blood inflow port has a relationship between the length G of the reduced diameter portion and the length of the cylindrical portion such that L/G≦0.5. . Furthermore, it is preferable that the blood contact surfaces of the blood processing device and the blood feeding tube be coated with an antithrombotic material. Further, it is preferable that the blood-contacting surface of the blood processing device is coated with an antithrombotic material. The feeding tube turning means causes the first feeding tube near the blood inflow port to draw a perfect circle or an ellipse around an extension line of a central axis of the blood inflow port of the blood inflow port or a vicinity thereof. It is preferable that it be rotated.

The blood processing apparatus of the present invention will be explained in detail using embodiments shown in the drawings.

The blood processing apparatus 1 of the present invention includes a housing 36, a blood processing member 42 inserted into the housing 36, and a partition wall that liquid-tightly fixes both ends of the blood processing member 50 to both ends of the nozzing 36. 20.21 and a blood processing chamber provided near both ends of the housing 36 and communicating with the space formed by one surface of the blood processing member 42, the inner surface of the housing 36, and the partition wall 20.21. Fluid inlet 1
3 and an outlet 14, and a blood inlet port 19 having a blood inlet 29 attached to one end of the how/puffer 36.
and a blood outflow port 18 having a blood outflow port 28 attached to the other end of the housing 36, a blood feeding tube 5 connected to the blood inlet 29 of the blood inflow port 19, The blood inflow port 19 of the blood processing device 3 includes a flat portion 19a forming a disk-shaped space 19c facing the partition wall 21, and a portion outside the center of the flat portion 19a. It has a cylindrical part 19b having a diameter-reducing part that protrudes toward the inner diameter and tapers toward the distal end, and further includes a diameter of the disc-shaped space 19c and a diameter of the disc-shaped space 19c. the thickness H of, and the inner diameter A of the connecting part between the flat part 19a and the cylindrical part 19b,
The relationship with the taper angle R of the cylindrical portion 19b is 3°<R<
20', 0.02<H/D<0.2, A/D<0.4
It satisfies the following conditions.

Therefore, the blood processing apparatus 1 of the present invention includes the blood supply tube rotation means 4.
By activating the blood processing device 3, the blood flow inside the blood inflow port 19 of the blood processing device 3, specifically, the flow velocity distribution of the blood flowing inside the blood inflow port 19 can be changed. The cylindrical portion 19b of the blood inflow port 19 of No. 3 has a tapered inner surface (in particular, the diameter increases toward the inside), so that the blood inflow from the blood tube 5 is rotated by the blood tube rotation means 4. The blood flowing into the port 19 passes through the cylindrical portion 19b while maintaining its swirling state to some extent, and the blood flows in, f! -) Flat part 19a of 19
Therefore, the flow velocity distribution of blood flowing inside the blood inflow port 19 can be changed more reliably. Therefore, it is possible to prevent a continuous formation of a constant flow velocity distribution within the blood inflow port, and to prevent the continuous formation of extremely low blood flow velocity areas that will form blood retention areas or future retention areas inside the blood port. This prevents the occurrence of thrombus inside the blood inflow port 19 of the blood processing device 3.

Therefore, the blood processing apparatus of the present invention will be explained using the embodiment shown in FIG.

The blood processing apparatus 1 of this embodiment includes a blood processing device 3, a first blood supply tube 5 connected to a blood inflow port of a blood inflow port 19 of the blood treatment device 3, and a first blood supply tube 5 attached midway through the first blood supply tube 5. a blood feeding tube turning means 4, a blood feeding pump 2 to which the other end of the first feeding tube 5 is attached, a third feeding tube 7 connected to the blood feeding pump 2, and a blood feeding tube 7 attached to the end of the third feeding tube 7. Blood removal cannula 11 , a second blood supply tube 6 connected to the blood outflow port of the blood outflow port 18 of the blood processing device 3 , a flow meter 8 attached to the second blood supply tube 6 , and an end of the second blood supply tube 6 The blood feeding cannula 12 is attached to the blood feeding cannula 12.

The flow of blood in the blood processing apparatus 1 of this embodiment is such that blood removed from a patient passes through a blood removal cannula 11,
The blood flows through the first blood supply tube 5, flows into the blood processing device 3 placed in a vertical position from below, undergoes necessary blood treatment, flows through the second blood supply tube 6, and flows through the blood supply cannula 12. blood is returned to the patient via the In addition, if necessary,
By operating the feeding tube turning means 4 attached to the feeding tube 5, the blood inflow port 19 of the blood processing device 3 is opened.
It can also change the flow of blood inside.

As the blood processing device 3 used in the blood processing device 1 of the present invention, an artificial lung, an artificial kidney, a plasma separator, an adsorption type blood purification device, etc. are used.

Specifically, as shown in FIG. 2, a housing 36,
The blood processing member housed in the housing 36 and the one end of the housing 36 are attached! ? - Attached blood inlet 2
A blood processor 3 is used having a blood inlet port 19 with a blood inlet port 9 and a blood outlet port 18 with a blood outlet 28 attached to the other end of the housing 36. The blood processing member 42 includes a gas exchange membrane for an artificial lung, a hemodialysis membrane for an artificial kidney, a plasma separation membrane for a plasma separator, and a plasma separation membrane for a blood purifier. Adsorbents are used.

A specific example of an artificial lung used as the blood processing device 3 is shown in FIG.

This oxygenator includes a hollow fiber membrane type oxygenator 40, which includes a housing 36, a gas exchange hollow fiber membrane 42 which is a blood processing member inserted into the housing 36, and both ends of the hollow fiber membrane bundle. Partition wall 20 liquid-tightly fixed to both ends of 36
．． 21 and near both ends of the housing 36, the space (oxygen chamber 5
2) an inlet port 13 for gas, which is a blood processing fluid, communicating with
and a gas outlet 14, and a blood inlet port I8 having a blood inlet 29 and a blood outlet 28 attached to both ends of the housing 36, respectively.

The hollow fiber bundles housed in the cylindrical housing 36 include hollow fiber membranes for gas exchange with to, 000 to 60.
The hollow fiber membrane 42 for gas exchange is a porous membrane having many fine holes passing through it. As a hollow fiber membrane for gas exchange, the inner diameter is 100 to 1000μ11, preferably 100 to 30μ
0μ11 wall thickness 5-80μl, preferably 10-60μ shoulder, porosity 20-80%, preferably 30-60%, and micropore diameter 0.01-5μl, preferably 001-
About 1 μl is preferably used. Further, the membrane is not limited to a hollow fiber membrane, but may be a flat membrane.

Materials for hollow fiber membranes for gas exchange include polypropylene,
Polymer materials such as polyethylene, polytetrafluoroethylene, polysulfone, polyacrylonitrile, and cellulose acetate can be used, preferably hydrophobic polymers, particularly preferably polyolefin resins,
More preferably, polypropylene is used, and polypropylene in which micropores are formed by a stretching method or a phase separation method is desirable.

To specifically describe the structure of the hollow fiber membrane type oxygenator 40 of this embodiment, both ends of the hollow fiber membrane 42 are fluid-tightly connected to the housing 46 by the partition walls 20 and 21 with the respective openings not being closed. It is fixed.

By this partition wall 20.21, the nounong 46
The interior is divided into an oxygen chamber 52 formed by the outer wall of the hollow fiber membrane, the inner wall of the hollow fiber membrane 46, and a partition wall, and a blood circulation space formed inside the hollow fiber membrane.

A blood inlet port 19 having a blood inlet 29 and an annular protrusion is fixed to the outside of the partition 21 by a screw ring 23, and a blood inlet port 19 having a blood outlet 28 and an annular protrusion 24 is fixed to the outside of the partition 20. Outflow port 18 or screw ring 2
It is fixed by 2. And blood port 18.1
9 is in contact with the partition wall 20.21, and on the outer periphery of this projection there are at least two holes 30.31.32.33.9 provided in each of the threaded rings 22.23.
18.1, each blood port 18.1
9 is fixed to the partition wall 20.2 in a liquid-tight manner.

As shown in FIGS. 2 and 3, the blood inflow port 19 includes a flat portion 19a forming a disc-shaped space 19c facing the partition wall 21, and a flat portion 19a that protrudes outward from the center of the flat portion 19a and has an inner diameter. has a cylindrical portion 19b having a diameter-reduced portion that tapers toward the tip side, and further includes a diameter of the disc-shaped space 19c and a diameter of the disc-shaped space 1.
The relationship between the thickness H of 9c, the inner diameter A of the connection part 19f between the flat part and the cylindrical part, and the taper angle R of the cylindrical part +9b is 3.
°<R<20°, 0.02<H/D<0.2, A/D<
The condition of 0.4 is satisfied.

The reason why the taper angle R of the cylindrical portion 19b is set to 3°<R<20° is because of separation of the flow of the fluid flowing inside the cylindrical body (in other words, uneven flow within the cylindrical portion).
The minimum taper angle that occurs is generally said to be 7°. However, in the present invention, the blood feeding tube 5 connected to the blood inflow port 29 of the blood inflow port 19 is rotated by the feeding tube turning means 4 at a certain angle with respect to the axis of the blood inflow port. The blood flow flowing into the port 19 is given an inflow angle due to the blood supply tube 5.

Therefore, if the taper angle R of the cylindrical portion 19b is larger than 3°, it is possible to cause a biased flow in the blood flow flowing inside the cylindrical portion.

Further, if the taper angle R of the cylindrical portion 19b is less than 20', the blood flow will flow only along the inner surface of the blood inflow port, as shown in FIG. 7C, and will flow into the center of the blood inflow port. No stagnation is formed.

Also, the diameter of the disc-shaped space 19c and the disc-shaped space +9c
If the relationship (H/D) with the thickness H is greater than 0.02, the pressure loss at the flat part will not become extremely large and the blood will flow to the peripheral part of the blood inflow port 19. There is no obstruction to inflow. Therefore, there is no risk of sudden occlusion at the end of the hollow fiber membrane in the event that a thrombus occurs. Furthermore, if H/D is smaller than 02, the blood retention area in the X portion shown in FIGS. 7A and 7B should not become large, and the priming volume in the blood inflow port should also be small. I can do it.

The diameter of the disc-shaped space varies depending on the blood processing capacity of the target blood processing device 3, in other words, the membrane area, but is generally 20! The length is about 1 to 1801 m. Further, the thickness H of the disc-shaped space 19c similarly varies depending on the blood processing capacity of the target blood processing device 3, but is generally about 1,5 zy to 301R.

Furthermore, the relationship between the thickness H of the disc-shaped space 19c and the inner diameter A of the connecting part between the flat part 19a and the cylindrical part 19b (A/D
) is smaller than 0.4, the priming volume within the blood inflow port can be made small, and furthermore, a stagnation part is formed in the center of the blood inflow port as shown in FIG. 7C. Is it possible to prevent this?

The inner diameter A of the connecting part between the flat part 19a and the cylindrical part 19b varies depending on the blood processing capacity of the target blood processing device 3, in other words, the membrane area, but is generally 3.
It is about Oxx to 60xx.

Ideally, the inner surface shape of the flat portion 19a is such that the flow rate of blood flowing in the radial direction (towards the periphery) within the blood inflow port 19 is constant, and the pressure applied to each hollow fiber membrane is constant; In other words, it is preferable to keep the flow rate of blood flowing inside each hollow fiber membrane constant, and for this purpose, the inner surface of the flat portion 19a is sloped so that it gradually approaches the partition wall 21 as it goes toward the periphery. It is preferable that it be a surface.

However, the flat portion 19a of the blood inflow port 19 in the present invention
As mentioned above, the thickness H of the flat part 19a is sufficiently thin as 0.02<H/D<0.2 with respect to the diameter of the flat part 19a, so the inner surface of the flat part 19a is, for example, The flat portion 19a may have a plane substantially parallel to the end surface of the partition wall 21, and as shown in FIG.
The peripheral edge of the flat portion 19a may be an inclined surface that gradually approaches the partition wall 21.

And, the thickness H of the disc-shaped space 19c is the disc-shaped space 1 at the connection part between the cylindrical part 19b and the flat part 19a.
9c of thickness, which is also the maximum thickness when looking at the entire disc-shaped space 19C.

In addition, as shown in FIG. 5, the end of the cylindrical portion 19b of the blood inflow port 19 maintains the tapered shape described above on the inner surface, while the outer circumferential surface is a circle having a nearly uniform outer diameter. It may also be formed into a columnar shape. By doing so, the connection of the blood vessel 5 can be facilitated.

Further, the relationship between the length G of the reduced diameter portion of the cylindrical portion 19b of the blood inflow port 19 and the diameter of the disc-shaped space is 1/10.
It is preferable that D<G<D. G is 1/1o-D
With the above, it is possible to reliably maintain the state of the swirling flow of blood given by the blood supply tube swirling means 4, and the G
However, if it is shorter than D, the priming volume within the blood inflow port will not become very large. The length G of the reduced diameter portion is preferably about 10 to 6011 mm.

Further, as shown in FIG. 4, the blood inflow port 19 has a cylindrical portion 19b which is connected to a tapered diameter reduced portion 19d and a cylindrical portion 19e having substantially uniform inner and outer diameters.
It may have. By doing so, the connection of the blood vessel 5 can be facilitated. In this case, the relationship between the inner diameter B of the connecting portion 19g between the cylindrical portion and the cylindrical portion 19e and the length of the cylindrical portion 19d is 0≦L<
It is preferable that it is B. If the cylindrical portion 19d, which has a substantially uniform inner diameter, is too long, there is a possibility that the swirling flow of blood given by the blood supply tube swirling means 4 will be corrected to a straight flow, but the length of the cylindrical portion 19d If L is smaller than the inner diameter B of the connecting portion 19g between the cylindrical portion and the cylindrical portion 19e, correction will not occur much.

Furthermore, the length G of the contracted portion 19d and the cylindrical portion 19e
It is preferable that the relationship between L and G is L/G≦0.5. Within this range, the blood supply tube rotation means 4
Blood flow in a swirling state given by blood inflow port 1
9 into the flat part 19a.

The length G of the reduced diameter portion of the cylindrical portion 19b of the blood inflow port 19 is preferably about 10xx to 60zx, and the inner diameter B of the connecting portion 19g between the cylindrical portion and the columnar portion 19e is 40
The length L of the cylindrical portion 19d is preferably about 13 mm to 13 mm, and the length L of the columnar portion 19d is preferably about 13 mm to 13 mm.

The blood supply tube rotation means 4 rotates the first blood supply tube 5 connected to the blood inflow port in the vicinity of the blood inflow port, thereby changing the flow of blood inside the blood inflow port 19. This turning by the turning means 4 is preferably performed by rotating the first blood supply tube 5 around an extension line of the central axis of the blood inlet of the blood inflow port 19 or around the same. Furthermore, it is preferable to make a 360° turn, but 180°
It may be one that reciprocates within a range of ~360°. In addition, the turning may be done by drawing a perfect circle (for example, it may be done by drawing an ellipse. Particularly preferably, the turning should be done so as to draw a nearly perfect circle around an extension of the central axis of the blood inflow port. It is preferable to let

By activating the blood supply tube rotation means 4, the blood stagnation portion within the oxygenator, particularly within the blood inflow port 19, can be eliminated.

Specifically, blood that flows into the blood inflow port 19 at a constant flow rate is dispersed within the blood inflow port 19 with a certain flow velocity distribution. However, if a constant flow rate is continuously maintained, the flow velocity distribution formed within the blood inflow port 19 will also be approximately constant. For this reason, partial retention or a portion where the flow velocity is extremely low compared to other portions is formed in the blood inflow port 19, which causes thrombus formation.

The flow of blood in the blood inflow port 19 in a state where the blood supply tube turning means 4 is activated will be specifically explained using FIGS. 7A and 7B.

As shown in FIGS. 7A and 7B, the instantaneous blood flow in the blood inflow port 19 flows along a part of the tapered inner surface of the cylindrical portion 19b, and the disk-shaped space formed by the flat portion 19a. 19c. And the X in Figure 7A
Most of the blood sent to the area flows through the disc-shaped space 19.
Since the thickness H of c is small, the flow velocity in the X portion is high, and the occurrence of stagnation in this portion is small. Furthermore, even if some flow separation (portion where the flow is slow) is formed in the X portion, the blood supply tube 5 is rotated by the blood supply tube rotation means 4 and the blood flow vector changes over time. The portion of the tapered inner surface through which blood flow travels also moves reliably. For this reason, the X portion also moves at the same time, and the blood inflow bow)
The way the blood flows through the port 19 changes, and the flow velocity distribution of the blood flow inside the port 19 is not constant and changes during the operating time. Therefore, the formation of a regular flow separation part or even a stagnation part in the blood inflow port 19 is prevented.

Further, as described above, the feeding tube turning means 4 may be either manual or automated as long as it can turn the first feeding tube 5 near the blood inflow port. As shown in FIG. 6, a specific example of the feeding tube turning means 4 includes a drive unit 60 that rotates two discs 62 and 64 at the same speed using one motor or two synchronized motors, and a drive unit 60 that rotates two disks 62 and 64 at the same speed, and It is conceivable to have a rod 66 rotatably attached to the upper surface of the disk 62, 64, and a blood vessel gripping portion 68 provided at the center of the rod 66.

Furthermore, the degree of rotation by the tube turning means 4 varies depending on the diameter of the tube, but when the tube is rotated in a nearly perfect circle, the degree of rotation by the tube turning means 4 varies depending on the angle with respect to the central axis, but the diameter is 50 to 500 zz. It is preferable to rotate it in a circular manner. In addition, the turning speed is 2 times/
Approximately 60 times/minute is preferable. Moreover, as for the turning state of the first blood supply tube 5, it is preferable to turn while maintaining an angle of about 30 to 70 degrees with respect to the extension line of the central axis of the blood inlet. If it is 30' or more, the flow velocity distribution within the blood port can be reliably changed, and 70'
If it is less than 0.0°, the first blood vessel will not bend at the connecting portion between the blood port and the first blood vessel, which is preferable.

As the first tube 5, the second tube 6, and the third tube 7, transparent flexible synthetic resin tubes such as vinyl chloride resin and silicone rubber can be suitably used. Further, a blood reservoir 9 may be provided in the third blood supply tube 7 if necessary.

The blood pump 2 pumps fluid at a constant pressure or flow rate. Blood pumps include constant-pressure centrifugal pumps, turbine pumps, and screw pumps.
Additionally, stationary pumps such as roller pumps and peristaltic pumps can be used.

In addition, when a constant pressure pump is used as a blood pump,
It is preferable to attach the flow meter 8 to one of the blood vessels. This is because when a constant pressure pump is used, it is difficult to check the flow rate from the rotation speed of the pump, so it is preferable to provide this for checking the flow rate. The flowmeter 8 is preferably one that can measure the flow rate of blood flowing inside the blood vessel without directly contacting the blood, and for example, an ultrasonic flowmeter is preferably used.

Furthermore, the blood contact surface of the blood processing device 1 of the present invention, in particular,
It is preferable that an antithrombotic material is fixed to the blood contact surfaces of the blood processing device 3 and each of the blood feeding tubes, as well as the blood removal cannula 11, the blood feeding cannula 12, and the like.

Examples of antithrombotic materials include polyurethane, polyalkylsulfone, ethyl cellulose, acrylic ester polymers, methacrylic ester polymers (for example, polyH
EMA C polyhydroquine ethyl methacrylate No. 8),
Block or graft copolymers having both hydrophobic and hydrophilic segments (e.g., HEMA-styrene-HEMA pro-copolymers, HEMA-LM
A E lauryl methacrylate dinofuronok copolymer, PVP C polyvinylpyrrolidone i-MMA block copolymer, a blend polymer in which this block copolymer is further mixed with a polymer having 7 amino groups), and fluorine-containing resins, etc. can be used. Preferably, H.E.M.
A-styrene-HEMA block copolymer, etc. After coating the blood contacting surface with the antithrombotic material, it is preferable to further immobilize heparin thereon. In this case, in order to immobilize heparin on the surface of the above-mentioned antithrombotic material, the antithrombotic material must have a hydroxyl group, an amine 7 group,
Contains or is easily converted into a carboxylic group, an epoxy group, an iso/anate group, an epoxy group, a thio/anate group, an acid chloride group, an aldehyde group, and a carbon-carbon double bond. It is preferable to use one having a possible group. Specifically, a method involves creating a heparin complex (for example, hensalkonium/heparin complex), coating the inner surface of a hollow fiber membrane with poor heparin fixing properties with, for example, polyurethane, and then fixing this heparin complex. is preferred.

Heparin fixation can also be done by fixing the blood-contacting surfaces of blood processing devices with cationic surfactants (e.g., primary, secondary, and tertiary amines and their salts, quaternary ammonia compounds, pyridinium, guadinium, After treating the surface with cetylamine hydrochloride, octadecylaminopropylamine hydrochloride) and contacting the surface with an aqueous heparin solution, aldehydes such as geltaraldehyde, terephthalaldehyde, and formaldehyde, diphenylmethane diisocyanate, 2,4 - Immobilization of the heparin by contacting with immobilizing agents such as tolylene diisocyanate, carbo/imide modified diphenylmethane diisocyanate, epichlorohydrin, 1,4-butanediol digly//dyl ether, polyethylene glycol/gly/dyl ether, etc. It's okay.

[Example] Next, an embodiment of the blood processing apparatus of the present invention will be described.

(Example) A hollow fiber membrane oxygenator was used as a blood processor.

The hollow fiber membrane oxygenator has a shape as shown in Figure 2, and is specifically made of polycarbonate and has a waste port and an outflow port near the end. Cylindrical housing (inner diameter 581N, length 120N)
．． About 12,000 hollow fiber membranes made of polypropylene with an inner diameter of about 200 μl, a wall thickness of about 50 μl, a porosity of about 45%, and an average pore diameter of about 700 are inserted into the membrane, and the gas inlet of the housing and the gas flow are After centrifugally injecting the botting agent (polyurethane) from the outlet, use a device with partitions formed by slicing the botting agent part, and inject each into the outside of the How/Fugu (end surface of the partition). An oxygenator with a membrane area of 0.8 x'' was prepared in which a blood port was fixed using a screw ring, and heparin was further fixed on the blood contact surface of this oxygenator.

In addition, as for the blood inflow port, the diameter of the disc-shaped space is 53zz, the thickness H of the disc-shaped space is 2.5 cm, and the inner diameter A of the connecting part between the flat part and the cylindrical part is 8.51 cm. The taper angle R of the cylindrical part is 10°, and the H/D is 0047.
, A/D of 0.16 was used.

The heparin fixation on the blood contact surface of the oxygenator was performed as follows.

Base agent (TPOOI, manufactured by Nippon Polyurethane Co., Ltd.),
A two-component curing type polyurethane consisting of a curing agent (4239, manufactured by Nippon Polyurethane Co., Ltd.) was used, and a 10% solution of each of the main agent and curing agent (dioxane, freon-
1゛1 solvent) was prepared.

After creating a solution by mixing these base agent solutions and curing agent solutions in a ratio of 161 parts, immediately fill the above solution from the inlet on the lower side of the oxygenator, turn it over, and allow the filled solution to fall naturally. It was discharged by Next, 112
/min for 2 to 3 minutes, and the polyurethane solution flowing out onto the lower partition surface was wiped off with acetone, and then dried in an oven at 60°C for 1 hour.

This operation was repeated twice by changing the inlet of the polyurethane solution, and the ends and inner surfaces of the hollow fibers of the oxygenator and the end faces of the partition walls were coated with polyurethane.

Additionally, benyldimethylstearylammonium chloride was dissolved in EtOH to create a 20% benyldimethylstearylammonium chloride solution, and further,
A 10% penzylonmethylstearylammonium chloride solution (A) was prepared by diluting it twice with water. On the other hand, dissolve heparin in water and dissolve 10% heparin aqueous solution (B
)It was created. The above heparin aqueous solution was added dropwise to the stirring solution A so that A:B=2:I, stirred for 1 hour, the formed precipitate was collected by filtration, and the washing solution (water, EtOH= After thoroughly washing with 2:l), the precipitate was dried in vacuum to obtain a dried precipitate. This dried material was dissolved in n-butanol to prepare a 1% henzalkonium chloride/heparin complex solution (BH bath solution).

As described above, the henzalkonium/heparin complex solution was filled into the polyurethane-coated oxygenator by a drop, and then the oxygenator was turned over and the filled solution was discharged by gravity. Next, 1σ/
Warm air at 60° C. was circulated inside the oxygenator for several minutes to wipe off the excess BH bath solution flowing out onto the lower partition wall surface, and then the oxygenator was dried. Then, the partition wall surface on the side that was not wiped as described above was left as is, and the partition wall surface that was wiped was coated with the above BH bath solution brush.
It was dried by blowing warm air at 0'C. In addition, the blood port and connector were immersed in the above BH solution to adhere to the surface of the BH bath solution, and then heated at 60°C.
Dry in the oven. Furthermore, after assembling the entire oxygenator, vacuum drying was performed at 50°C for 24 hours.

As shown in FIG. 6, the feeding tube turning means includes a drive unit 60 that rotates two disks 62 and 64 at the same speed using one motor, and a drive unit 60 that rotates the two disks 62 and 64 on the upper surface thereof. Attached mouth.

A rod 6 having a blood vessel gripping portion 68 provided at the center of the rod 66 was used.

Then, a vinyl chloride tube with an inner diameter of 611N with a blood removal cannula with an inner diameter of 5.3 zy attached to the end was connected to the blood inlet of the oxygenator, and the above-mentioned blood supply tube rotation means and blood supply pump were attached to this tube. Ta. In addition, an inner diameter 6x blood cannula with an inner diameter of 4 and 7 wz attached to the end.
The vinyl chloride tube x was connected to the blood outlet of the oxygenator, and the oxygenator was placed almost vertically with the blood inlet facing downward. A flow meter was also attached to this tube.

As the flow meter, a Transisototime blood flow meter (Transonic ■, manufactured by Advance Co., Ltd.) was used, and as the blood pump, a bio pump (product number BP-50, manufactured by Biomedics Co., Ltd.) was used.

Furthermore, the tube, blood feeding cannula, and blood removal cannula used had heparin fixed on the blood contact surface. To fix heparin to the tube and cannula, use an ozone generator (manufactured by Japan Ozone Co., Ltd.) to heat the tube and cannula to 100 V, 0, 81
2/1ono! After treating ozone generated under the following conditions at 50°C for 20 minutes, 0.5% PE I (pH 1
0,0) and further treated at 45°C for 20 hours. Subsequently, 10% heparin aqueous solution (0.25N H
.

02% aqueous solution of denatured heparin (containing So4) at 97°C for 10 minutes to partially have amide 7 groups (1)
After contacting with H4,O,0,1M citrate buffer),
The blood contact surface of the tube was treated at 45°C for 14 hours, and then brought into contact with a 0.5% geltaraldehyde aqueous solution (pH 4, 0,0,01M citrate buffer), and then treated at 37°C for 20 hours. Heparin was covalently bound to.

Also, regarding the connectors used in the circuit,
A blood processing device of the present invention was created using a blood-contacting surface on which heparin was immobilized in the same way as in the above-mentioned artificial lung.

The rotation of the blood supply tube by the blood supply tube rotation means is performed by moving the portion of the blood supply tube 5 connected to the blood inflow port of the blood inflow port 19 of the oxygenator 3 by about 20 cm, and centering on the extension line of the central axis of the blood inflow port. , at an angle of 60° and at a speed of 1 turn/20 seconds so as to draw a nearly perfect circle.

(Comparative Example 1) Blood processing was carried out using the same device as in Example 1, except that the blood supply tube turning means was not provided and the same blood outflow port of the oxygenator shown in the second example was used as the blood inflow port. Created the device.

(Comparative Example 2) A blood processing device was created using the same device as in Example 1, except that the blood inflow port was the same as the blood outflow port of the artificial lung shown in the second example.

(Reference Example) A blood processing device was created using the same device as in Example 1, except that the blood supply tube rotation means was not provided.

[Experiment] (Experiment 1) A simulated blood circuit shown in FIG. 8 was prepared using the blood processing apparatuses of Example, Comparative Example 1, Comparative Example 2, and Reference Example.

As the circulating fluid, a substantially neutral liquid obtained by adding a small amount of phenolphthalein to a 35% aqueous glycerin solution was used. Then, - temporarily stop the centrifugal pump 2 and add the above liquid through the mixed injection 081.

After injecting 1 cc of alkaline liquid to which NaOH has been added to give a concentration of 5N and dispersing it uniformly within the blood port (turns red), 5N of HCI is injected into the tank 82.
0 μQ was added, and the time until the color in the blood port disappeared was measured. . The results were as shown in Table 1.

Table 1 [Time for coloring to disappear (S)] *The numerical values in the table are for the Z and W parts (Z/W) shown in Figure 9.
It shows the time until the retention in W) disappears.

(Experiment 2) Using the blood processing apparatus of Example and Comparative Example 1, perform femoral artery and vein A-V Bypass by self-blood pressure drive on a mongrel dog.
was carried out for 24 hours. In the experiment, the blood flow rate was 250 x Q/s.
The test was carried out using non-heparin, using 20 to 9 mongrel dogs. After the blood circulation was completed, the artificial lung was washed with physiological saline, and the state of thrombus formation on the inner surface of the blood inflow port was confirmed.

As a result, no thrombus was observed on the inner surface of the blood inflow bowl 19 in the blood processing apparatus of the example. On the other hand, in the blood processing device of Comparative Example 1, thrombus adhesion was observed at the connecting portion between the cylindrical portion of the blood inflow port and the funnel-shaped expanding portion.

[Effects of the Invention] The blood processing device of the present invention includes a housing, a blood processing member inserted into the housing, and a partition wall that liquid-tightly fixes both ends of the blood processing member to both ends of the housing. and provided near both ends of the housing,
A blood processing fluid inlet and an outlet communicating with a space formed by one surface of the blood processing member, an inner surface of the housing, and a partition, and a blood inflow port attached to one end of the housing. A blood processing device having a blood inflow port and a blood outflow port having a blood outflow port attached to the other end of the housing, a blood supply tube connected to the blood inflow port of the blood inflow port, and the blood supply tube. Further, the blood inflow port of the blood processing device has a flat part forming a disc-shaped space facing the partition wall, and a flat part protruding outward from the center of the flat part. , and a cylindrical portion having a diameter-reducing portion whose inner diameter tapers toward the tip,
And, the relationship among the diameter of the disc-shaped space, the thickness H of the disc-shaped space, the inner diameter A of the connecting part between the flat part and the cylindrical part, and the taper angle R of the cylindrical part is, 3°〈R〈200
．． The conditions of 002<H/D<0.2 and A/D<0.4 are satisfied. Therefore, by operating the blood supply tube turning means, the flow of blood inside the blood inflow port of the blood processing device,
Specifically, since the flow velocity distribution of blood flowing inside the blood inflow port can be changed, and the cylindrical part of the blood inflow port of this blood processing device has a tapered inner surface,
The blood flowing into the inflow port from the blood supply tube in a swirled state by the blood supply tube swirling means passes through the cylindrical part while maintaining the swirling state to some extent, and flows into the flat part of the inflow port, so that the blood flow can be more reliably carried out. It is possible to change the flow velocity distribution of blood flowing inside the blood inflow port. This prevents the formation of a continuous flow velocity distribution within the blood inflow port, and prevents a continuous portion of extremely low blood flow velocity from forming a blood stagnation portion or a future stagnation portion inside the blood port. The formation of blood clots within the blood inlet port of the blood processor can be prevented.

[Brief explanation of the drawing]

FIG. 1 is a schematic diagram of an embodiment of the blood processing apparatus of the present invention;
FIG. 2 is a sectional view showing an example of a blood processing device used in a processing device, FIG. 3 is a sectional view showing an example of a blood inflow port used in the blood processing device of the present invention, and FIG. , sectional view showing another example of the blood inflow port used in the blood processing device of the present invention, FIG. 5 is a sectional view showing another example of the blood inflow port used in the blood processing device of the present invention, FIG. 6 is a diagram showing an example of a blood supply tube turning means used in the blood processing apparatus of the present invention, and FIGS. 7a, 7b, and 7c are
FIG. 8 is an explanatory diagram of the inside of the blood inflow port to explain the flow of blood. FIG. , is an explanatory diagram of the experimental results of the experiment. 1...Blood processing device, 2...Blood pump, 3.
...Blood processing device, 4... Blood supply tube rotation means, 5...
・First blood vessel, 6...Second blood vessel, 7...Third
Blood supply tube, 8...Flowmeter, lO...Flow rate adjustment member, 11...Blood removal cannula, 12...Blood feeding cannula, 18...Blood outflow port, 19...Blood inflow port, 19a... Flat part 19b... Cylindrical part
19c...Disk-shaped space Figure 7B Figure 8

Claims (7)

[Claims] (1) A housing, a blood processing member inserted into the housing, a partition wall that liquid-tightly fixes both ends of the blood processing member to both ends of the housing, and a partition wall provided near both ends of the housing, respectively. A blood processing fluid inlet and an outlet are provided and communicate with a space formed by one surface of the blood processing member, an inner surface of the housing, and a partition wall, and a blood flow attached to one end of the housing. a blood processing device having a blood inflow port having an inlet; a blood outflow port having a blood outflow port attached to the other end of the housing; a blood feeding tube connected to the blood inflow port of the blood inflow port; a blood supply tube turning means for rotating the blood supply tube, and the blood inflow port of the blood processing device has a flat part forming a disc-shaped space facing the partition wall, and a part extending outward from the center of the flat part. It has a cylindrical part that protrudes and has a diameter-reducing part whose inner diameter tapers toward the distal end, and further includes a diameter D of the disc-shaped space and a thickness of the disc-shaped space. The relationship between H, the inner diameter A of the connecting part between the flat part and the cylindrical part, and the taper angle R of the reduced diameter part of the cylindrical part is 3°<R<20°, 0.0
A blood processing device characterized by satisfying the following conditions: 2<H/D<0.2 and A/D<0.4. (2) The cylindrical portion of the blood inflow port has a cylindrical portion that is continuous with the reduced diameter portion and has a substantially uniform inner diameter, and a connecting portion between the reduced diameter portion and the cylindrical portion. The blood processing device according to claim 1, wherein the relationship between the inner diameter B of the cylinder and the length L of the columnar portion is 0≦L<B. (3) The relationship between the length G of the reduced diameter portion of the cylindrical portion of the blood inflow port and the diameter D of the disc-shaped space is 1/1.
The blood processing apparatus according to claim 1, wherein 0.D<G<D. (4) The cylindrical portion of the blood inflow port has a relationship between the length G of the reduced diameter portion and the length L of the cylindrical portion.
3. The blood processing device according to claim 2, wherein /G≦0.5. (5) The blood contact surfaces of the blood processing device and the blood supply tube are coated with an antithrombotic material.
5. The blood processing device according to any one of 4 to 4. (6) The blood processing device according to any one of claims 1 to 4, wherein the blood contacting surface of the blood processing device is coated with an antithrombotic material. (7) The feeding tube turning means causes the first feeding tube near the blood inflow port to draw a perfect circle or an ellipse around an extension line of a central axis of the blood inflow port of the blood inflow port or a vicinity thereof. Claims 1 to 6 are for rotating the
The blood processing device according to any one of.