JPS60246763A - Blood storage tank - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION ■ BACKGROUND TECHNICAL FIELD OF THE INVENTION The present invention relates to a blood reservoir. More specifically, the present invention relates to a closed blood storage tank equipped with a defoaming device.

Conventional technology.

In recent years, artificial heart-lung circuits using model oxygenators have been widely used. This artificial heart-lung circuit consists of a blood reservoir, a blood pump, an artificial lung, etc., and safely sends blood removed from the human body and a suction wheel from the surgical field to the artificial artery.

The reason why a blood reservoir is provided in a cardiopulmonary circuit is to deal with fluctuations in blood flow during circulation, such as when the amount of blood removed decreases or when it is desired to increase the amount of blood delivered. The purpose is to store it in the circuit.

Another reason is to effectively remove air bubbles generated in the circuit.

By the way, air bubbles may get mixed into the blood removal tube when the blood removal catheter is insufficiently placed in the blood vessel or when it is removed during a surgical procedure.

If the air bubbles mixed in this way cannot be removed sufficiently in the circuit, there is a risk that they may flow into the body, causing microvascular embolism in various organs, including the brain, or causing post-surgical brain damage. be.

There are two types of blood reservoirs installed in artificial heart-lung circuits: open type 1 and closed type.

Closed blood storage tanks have advantages such as good biocompatibility, low risk of air bubbles being mixed in, and the ability to reduce unnecessary blood storage, and are increasingly being used in combination with model oxygenators.

However, unlike the open type, a closed type blood storage tank has a problem in that if air bubbles should flow into the blood storage tank, they are not automatically removed and must be removed by some external means.

If the air bubbles are left unremoved, the air bubbles accumulated inside will leak out and cause a serious accident as mentioned above.

Conventionally, the methods for removing air bubbles in this sealed blood storage tank are: ■) Using a combination of a three-way stopcock and a syringe A three-way stopcock and syringe are installed at the deaeration port at the top of the blood storage tank, and the pressure inside the exhaust port is reduced using the syringe. to guide the air bubbles into the exhaust port, and then open the stopcock to remove the air bubbles.

2) Reverse [Method of using a syringe as a pump using a 1F valve] The same operation as 1) is performed by interlocking a syringe and a reverse 1F valve.

3) How to use a suction pump etc.

However, in either case, the air bubbles in the blood reservoir must be manually removed after they are detected, which is very time-consuming and requires complicated equipment to be installed in the blood reservoir. The disadvantage is that it does not.

II. Purpose of the Invention The present invention was made in view of the above-mentioned circumstances, and, like an open blood reservoir, in a closed blood reservoir, blood contaminants that naturally enter from the blood inflow port, even unintentionally. The present invention provides a closed blood reservoir having a mechanism capable of removing air bubbles.

These objects are achieved by the present invention as described below.

That is, the first invention is A flexible container having an internal space capable of storing blood.

This blood storage tank includes an exhaust port provided at the upper part of the container, and a blood inlet and a blood outlet that communicate with the inside of the container, and the exhaust port has a specific gravity of blood. This blood storage tank is characterized in that it is equipped with a valve means for communicating the inside of the blood storage tank with outside air and exhausting the gas in the blood storage tank by means of a valve body smaller than the size of the valve body.

Further, in an embodiment of the present invention, in the first invention, the valve means has a locking portion that engages the valve body on an outside side and an inside side of the container, respectively.

A second invention provides a flexible container having an internal space capable of storing blood, an exhaust port provided at the top of the container, and a blood inlet and a blood outlet communicating with the inside of the container. The exhaust port portion is provided with a valve means for communicating the inside of the blood storage tank with the outside air and exhausting the gas in the blood storage tank by means of a valve body having a specific gravity smaller than that of blood, and the exhaust port part has a rough shape. The blood storage tank is characterized in that a blood splash prevention means is provided above the valve means.

Further, in the second aspect of the present invention, the valve means has locking portions that lock the valve body on the outside and inside of the container, respectively.

■ Specific structure of the invention The specific structure of the invention is shown in FIGS. 1, 2, and 3 below.
A detailed explanation will be given according to the embodiment shown in the figures.

The container 10 of the blood reservoir 1 of the present invention is itself constructed from a flexible material.

In this case, the material should not alter the quality of the blood.
It is preferable to use a material that is free from effluents and does not contain eluates, and it is preferable to use a blood-compatible material such as silicone, rubber, polyvinyl chloride, polycarbonate-1, or ethylene-1-vinyl acetate copolymer.

By making the container IO flexible, it is possible to reduce the amount of air inside the container IO to a very small amount before use, which minimizes the possibility of air getting into the blood when blood flows in. can do.

When the container is rigid, as will be described later, since the valve means 2 is provided, the internal pressure becomes a pressure barrier when reducing the amount of blood in the container, making it difficult to control the amount of blood, resulting in inconvenience. This inconvenience is not a problem if the bag is flexible.

On the other hand, the container 10 is provided with a blood inlet 11 and a blood outlet 12 so as to communicate with the inside thereof.

Further, a communication port 15 is provided as necessary.

These are usually disposed at the bottom of the container 10 and have a tube shape.

In this case, it is preferable that the blood inflow port 11 has a closed end 111 and has two or more openings inside the container 10.

By having two or more plural openings, the rotational flow or vortex flow of blood flowing in becomes small, and the plurality of rotational flows cancel each other out.

In addition, the blood inflow port may be formed as a straight tubular duplex with an open end without being configured in this manner, but the ability to remove seven bubbles is insufficient compared to the case described in item h.

There are various ways to provide two or more openings as the openings of the blood inflow port 11. The tube-shaped inflow port can be branched, the tube tip can be made into a spiral shape, etc.
It is Noh.

However, from the viewpoint of ease of manufacturing and ensuring a sufficient amount of blood to be removed, the blood inflow port 11 is made into a tube body as shown in the figure, the tip of the tube body is sealed, and the downward direction from this sealed end is It is preferable that a plurality of side ports 115 are provided and opened throughout.

Various configurations can be considered for the configuration and arrangement of the side opening 115 formed by opening on the side surface of the tube body 11 whose tip end is sealed.

For example, it is preferable that the shape of the side ports 115 is circular or oval so that blood can easily flow out, that a plurality of side ports 115 are provided, and that the arrangement is such that the flow of blood can be relaxed. The side ports 115 are preferably arranged in at least two rows symmetrically with respect to the axis of the tube body in the axial direction.

In the upper part of such a container 10, an exhaust port 3 and a mouth 17 for mixed injection and sampling are formed.

The exhaust port 3 is provided with a valve means 2, preferably having a so-called two-way stop 1 function, for exhausting and retaining the gas in the blood reservoir.

The valve means 2 consists of a valve chamber 21 and a valve body 23.

In the example shown in FIG.
It has a lower valve seat 252 provided on the side of the container having the upper part, and an upper valve seat 251 provided on the upper side, that is, the outside air side.

When the valve means 2 is opened, the inside of the blood reservoir and the outside air are communicated with each other.

In this case, a spherical valve body 23 is accommodated in the valve chamber 21, and the valve means 2 is configured as a ball valve having a bidirectional stop function.

Normally, an internal pressure of 30 to 100 cmH20 is applied to the blood reservoir 1 due to the head difference from the patient's position to the blood reservoir, and the valve body 23 is 1 1/2 cm in contact with the upper valve seat 251 due to this internal pressure and buoyancy. This prevents two parts of the nu liquid from flowing out to the outside air.

On the other hand, if air bubbles flow into the dislocation tube of the oxygenator,
The air bubbles enter the blood reservoir 1 from the inlet port ll of the blood reservoir.

The inflowing air bubbles gather at the upper part of the blood reservoir, pass through the lower valve seat 252, and accumulate in the valve chamber 21.

When the amount of bubbles flowing into the valve chamber 21 reaches a certain level (when
When the valve element 23 loses its buoyancy and lowers, air bubbles within the valve chamber 21 are discharged upward through the upper valve seat 251.

After defoaming, the blood level rises due to the positive pressure inside the blood reservoir 1, but the valve body 23, which has received buoyancy from the blood, hits the upper valve seat 251 and is locked, and the inside of the blood reservoir 1 is sealed from the outside air. be done.

That is, the valve body 23 needs to be made of a material whose specific gravity p is smaller than that of blood.

Usually, it is taken as ρ. . .

In order for the valve body 23 to receive the valve body in this way, its own specific gravity ρ must be 1 or less, and the material may be hollow aluminum, hollow stainless steel, hollow glass, hollow styrene, hollow polycarbonate, etc. apart from.

Made from materials with specific gravity ρ of 1 or less, such as polypropylene and polyethylene. The valve seats 251 and 252 may be made of silicone foam, polyurethane foam, polystyrene foam, etc., and those with a smooth surface are preferable. A soft rubber material such as rubber, butyl rubber, or isobutylene rubber is suitable, and it may be formed integrally with the container 10 of the blood reservoir 1 made of a flexible material.

In addition, when the valve body 23 is made of a soft material, a hard material such as stainless steel, aluminum, or hard plastic is suitable.

When both the valve body 23 and the valve seat 251 are made of hard materials,
It is preferable to prevent blood leakage by increasing the precision of mutual fitting and bringing them into close contact.

Furthermore, when a certain amount of internal pressure is applied to the valve chamber 21,
The valve body 21 is pressed against the valve seat 251 by the internal pressure. At this time, if the valve chamber 21 is filled with bubbles, the valve body 2
1 must immediately fall under its own weight.

Therefore, in order for the valve body 21 to fall due to its own weight, the weight of the valve body 23 is sufficient to absorb the internal pressure from the lower valve seat 252 side by comparing the diameter of the lower valve seat 252 and the size of the valve body 23. It must be heavy enough to withstand.

That is, the weight Wgr of the valve body 230 and the opening area S of the valve seat
The ratio W/S of r:rIf must be larger than the internal pressure that can be applied.

More specifically, when the diameter of the valve seat 2.51 is dc+w, the internal pressure is Pcm, and the weight of the H2O valve body 23 is Wgr, the following formula (1) must hold true.

W 〉 πd 2 P 7.4---Set (1)
'Here, the diameter of the valve seats 251 and 252 must be 5.5 mm in order to prevent the air lock phenomenon caused by the surface tension of air bubbles.
A length of about mm or more is required.

Therefore, the diameter of the valve seat 252 was set to 0.5c (d=0, .5
), set the internal pressure to 50cmH20 (P = 50), and set the valve body 2
Letting the radius of 3 be rcm, it is entered into equation (1).

The specific gravity of the valve body 23 is less than 1 in Komi, but when calculated as Habor, 4πr3/4>πd2 P/4, r>
In order to satisfy practical conditions, the diameter of the pole-shaped valve body 23 must be 2.6 cm or more.

If the diameter is smaller than this, the valve body 23 will be pressed against the valve seat 2.51 by internal pressure, and even if the liquid level drops, it will not be able to fall due to its own weight, and the purpose of the present invention may not be achieved.

With such a configuration, even if the blood flow rate decreases and the pressure inside the blood reservoir 1 decreases, air will not be sucked through the exhaust port 3.

That is, when the pressure inside the blood storage tank 1 decreases and external air flows into the valve chamber 21, the valve body 23 descends with the liquid level and eventually hits the lower valve seat 252, so that the valve body 23 fulfills its function as a valve. , air is prevented from flowing into the blood reservoir l.

When the blood storage tank l is sufficiently filled with blood and the internal pressure is restored, the valve body 23 separates from the lower valve seat 252, and as the liquid level rises to a positive pressure, the valve body 23 also rises and hits the upper valve seat 251. stopped and blood exposure is prevented.

In this way, the so-called double-sided operation by the valve body 23! As shown in FIG. 1, the valve means 2 having an open/stop function includes a valve body 23, a valve chamber 21, a two-part valve seat 251, and a lower valve seat 25.
It can be configured by two locking parts of 2.

Alternatively, as shown in FIG. 2, a valve chamber 21 is provided in communication with the exhaust port 3, and the upper narrow passage portion of the valve chamber 21 is used as a valve seat 255. Inside, there is an upper engaging part 23 that can engage this valve seat 255 from above.
1 and a valve body 23 having a needle valve structure, which accommodates a valve body 23 having a lower engagement IF portion 232 that can be engaged from below.

In this case, the sealing of the blood reservoir layer 1 during positive pressure is performed by air bubbles coming out from the valve seat 255 to the valve seat 255 of the lower locking portion 232 of the valve body 23. When the valve body 23 loses its buoyancy and falls, the air inflow is prevented by engaging the upper/lower retaining portion 231 with the valve seat 255.

In another embodiment, as shown in FIG.
The operation of the needle valve shown in FIG. 3 is the same as that of the pole valve shown in FIG. be.

More preferable results can be obtained when at least one conical portion is formed above and/or below the valve body 23 to lock the upper and/or lower valve seats as a locking portion.

At this time, the aperture d of the valve seat can be made smaller than the spherical valve body 23 as shown in FIG. This is because it is carried out more smoothly.

Incidentally, it is preferable that both the upper and/or lower conical portions of the valve body 23 are tactile. Further, at this time, the cross-sectional shape of the valve body 23 can be variously formed, such as a hexagonal shape or a square shape, as shown in the figure.

Further, in the blood storage layer l of the present invention, by providing a cylindrical body or the like of a predetermined length above the valve means 2, when the blood bubbles generated in the valve means 2 disappear, the blood does not scatter to the outside of the blood storage tank. may be prevented.

However, in order to make the blood storage tank 1 smaller, it is preferable to provide a blood scattering 1F means above the valve means 2 and communicating therewith.

This blood scattering prevention means 1 is shown in Figures 1, 2, and 3.
As shown in the figure, it is preferable to include a defoaming means 5 connected to the upper part of the valve chamber 21. is lowered by its own weight without receiving any buoyancy, and when the bubbles pass through the valve seat 251.255, they are scattered to the upper outer part along with the bubbles: 22;
Blood scattering prevention τF means to eliminate and remove this has achieved its purpose! Although the structure is not particularly limited as long as it can be used, the defoaming means 5 is preferably made of a porous material such as foamed polyurethane or C±polypropylene mesh.

In particular, those coated with silicone oil have an excellent antifoaming effect and are preferred.

In addition to the 1F blood scattering prevention means ti in the present invention and the 1F bubble means, it is preferable to have a sterilization filter 6.

In this case, it is preferable to provide a sterilization filter 6 in a portion of the defoaming means 5.

The material 1 of the sterilizing filter 6 is not particularly limited as long as it has a sterilizing effect, but nonwoven fabrics such as polyester and polyolefin are preferred. Also,
Organic materials and inorganic materials other than these can also be used as appropriate.

(2) Specific effects of the present invention The blood storage layer of the present invention is used through the artificial heart-lung circuit side.

That is, as shown in Fig. 4, the Mn liquid C, which has been drained from the patient's vein by a drop, passes through the line H3, passes through the suction plane t-h from the surgical field, and is temporarily stored in the cardio1-mi blood reservoir K. S-there? 0 Blood reservoir layer 1 with bubbled blood
It leads to 0.

Thereafter, blood is sent to the affected artery by a blood pump P through an artificial tube and a heat exchanger.

When air bubbles are mixed into the blood, they gather inside a portion of the valve chamber of the blood reservoir layer 1, causing the valve element 23 that comes into contact with the valve seat to lose its buoyancy and fall. At this time, the air bubbles collected in the valve chamber 21 are released to the outside through the valve seat.

After the bubbles are removed, the valve body 23 rises again and is automatically locked to the valve seat, and the inside of the blood storage layer 1 is automatically sealed.

Furthermore, even when the blood reservoir layer is depressurized, the valve body 23 is held against the valve seat and air is not sucked in.

■Specific Effects of the Invention In the present invention, a valve means having a bidirectional stop function of the valve body 23 is provided at the exhaust port of a closed type blood storage layer made of a flexible container, so that no special operation is required. , it is possible to automatically remove air bubbles, which was the biggest problem with closed blood reservoirs.

Therefore, the risk of air bubbles flowing into the human body etc. from the blood reservoir layer is reduced, safety is increased, and handling is extremely advantageous.

Furthermore, even if the blood reservoir is depressurized, air can be prevented from being sucked in from the outside.

Further, in the second invention, on the upper part of the valve means provided at the exhaust port,
Furthermore, since the blood scattering prevention means is provided, when air bubbles are removed by the valve means, it is possible to prevent blood from scattering outside the blood reservoir and to reduce the amount of blood priming.

Furthermore, by providing a sterilization filter in addition to the blood scattering prevention means, it is possible to completely prevent the risk of contamination by bacteria or the like from the outside world.

And the first and the first? According to the embodiment of the present invention, since the locking portions are provided which engage each other on the outside and inside of the container, the bidirectional stopping function is performed very smoothly.

The present inventor conducted an experiment using the means diagrammatically shown in FIG. 5 in order to confirm the effects of the blood storage layer of the present invention described above. The results are shown in Table 1.

In FIG. 5, R is a blood storage part, IO is a blood storage tank, T is a graduated air trap part, and ■ is an air injection part.

A blood reservoir having a flexible bag-like container made of polyvinyl resin and measuring 160×170+sm as shown in FIG. 1 was prepared (No. 1).

The valve body 23 is made of polypropylene acid, diameter 4 cm, 28 g.
The diameter of the valve seat 252 was 1.2 cm.

As the blood storage tank (No. 2) for comparison, an open type without any means attached to the exhaust port was used, and although the blood storage tank of the present invention is a closed type, it has the same bubble-free effect as the open type. It was demonstrated that there is.

In addition, the blood storage tank (No. 3) of another comparative example was of a closed type, and it was shown that it had no function of removing air bubbles.

Heparin-added fresh blood at 37° C. was used in the experiment, and blood was led from the blood storage portion R to the blood storage tanks of the present invention and the comparative example described above by a drop, and the blood was circulated by a blood pump P.

120mR/min with a syringe during air injection work
Air (total of 600 ml) was injected into the circuit of FIG. 5 for 5 minutes at a rate of .

Thereafter, the amount of air stored in the air reservoir of the air trap section T was measured. The blood flow rate was 3.4°/win.

As is clear from Table 1 below showing the results, in the blood storage tank according to the present invention, the air trapped in the air trap section T, that is, the amount of air that has passed through the blood outflow port of the blood storage tank, is It can be seen that the effect is much smaller than that of the open type (No. 3), and is almost the same as that of the open type (No. 2).

Table 1 No. 1 invention 0', 05'0.10 0.12

[Brief explanation of drawings]

FIG. 1 shows an embodiment of the invention. It is a front view with a part cut away. FIGS. 2 and 3 are partial cross-sectional views showing other embodiments of the present invention, respectively. FIG. 4 is a schematic diagram for explaining the present invention in detail. FIG. 5 is a circuit diagram for explaining an experiment to confirm the effects of the present invention. l...Blood storage tank, 10...Container, 11...Blood inlet, 12...Blood outlet, 17...Sampling mouth, ill...Blood inlet Tip, 112... Side opening, 2
... Valve means, 21 ... Valve chamber, 23 ... Valve body, 2
51..."Two-part valve seat, 252...Lower valve seat, 25
5...Valve seat, 3...Exhaust port, 5...Defoaming means, 6...Anti-bacterial filter patent applicant Chilshichi Co., Ltd. agent Patent attorney Yo Ishii - 1-1葆2 Figure 6 Figure 3 Figure 4 Figure 5

Claims (1)

[Claims] 1) A flexible container having an internal space capable of storing blood, an exhaust port provided at the top of the container, and a blood inlet and a blood outlet communicating with the inside of the container. The blood storage tank is equipped with a valve means for communicating the inside of the blood storage tank with outside air and exhausting the gas in the blood storage tank by means of a valve body having a specific gravity smaller than that of blood. A blood reservoir characterized by. 2) The valve means engages the valve body on the outside and inside of the container, respectively! The blood reservoir according to claim 1, which has a locking portion that holds the blood. 3) A blood storage tank comprising a flexible container having a flexible internal space, an exhaust port provided at the top of the container, and a blood inlet and a blood outlet communicating with the inside of the container. The exhaust port portion includes a valve means for communicating the inside of the blood reservoir with the outside air and exhausting the gas in the blood reservoir by means of a valve body having a specific gravity smaller than that of blood, and further includes a valve means on the upper part of the valve means. A blood storage tank characterized by being provided with a means for preventing blood from flying. 4) The blood reservoir according to claim 3, wherein the valve means has locking portions that lock the valve body on the outside and inside of the container, respectively.