JP6953162B2 - Blood purifier - Google Patents

Description

The present invention relates to a blood purifier.

A technique for purifying blood by using a blood purifying device together with a blood purifying device for purifying blood circulating outside the body (hereinafter, also referred to as "extracorporeal circulating blood") is widely known.

In blood purification treatment, in general, as water and waste products are removed from the blood, various methods such as dilution of extracorporeal circulating blood, increase in purification amount, adjustment of substance balance such as water and electrolyte, and adjustment of pH are performed. For the purpose, fluid replacement is supplied to the extracorporeal circulating blood.

As a method of supplying fluid replacement to extracorporeal circulating blood, a so-called "pre-dilution" method of supplying fluid replacement to extracorporeal circulating blood before flowing into the blood purifier, extracorporeal circulation after flowing out of the blood purifier Examples include the so-called "post-dilution" method of supplying fluid replacement to the blood, and combinations thereof. In either method, conventionally, a tubular member for supplying replacement fluid (hereinafter, also referred to as “refill fluid inlet tubular member”) is connected to the blood circuit or the drip chamber on the blood circuit to circulate blood outside the body. Is supplying fluid replacement.

For example, in Patent Document 1 (Japanese Unexamined Patent Publication No. 2011-110098), a first connection which is a blood purification device applied to online hemodialysis filtration and is connected to an arterial chamber 9 of an arterial blood circuit 2. A blood purification apparatus having a line L4, a second connection line L5 connected to the venous chamber 10 of the venous blood circuit 3, and a dialysate supply line L6 connected to the arterial blood circuit 2 is described. .. The blood purification apparatus described in Patent Document 1 supplies dialysate to extracorporeal circulating blood as a replacement fluid via a first connection line L4, a second connection line L5, and a dialysate supply line L6 (Patent Document 1). 1), paragraphs 0023, 0031, 0032, and 0042 to 0045, and FIGS. 3 to 5 and the like).

As other conventional methods of supplying replacement fluid to extracorporeal circulating blood, for example, Patent Document 2 describes an arterial blood reservoir as an arterial chamber (46), a venous blood reservoir as a venous chamber (64), and a manifold. A method of providing a salt water tube (98) in an arterial blood reservoir (46) and supplying salt water from the salt water tube (98) in a special cartridge (42) including (51) and the like is described (Reference 2). See Fig. 2 etc.). As described above, the development tendency of the conventional blood purification device has been to solve each problem by adding special and complicated parts such as a blood tube set (BTS).

Japanese Unexamined Patent Publication No. 2011-110098 Patent No. 3951030

In recent years, as the number of patients requiring blood purification has increased, the number of patients that one nurse or doctor must be in charge of at one time has increased, and the workload has increased. For example, in the field of blood purification treatment, one nurse or doctor may be in charge of 10 or more patients at a time. At this time, if there are 10 checkpoints (actually, it is considered to be more than that) for the connection and disconnection of the blood circuit, etc. for each blood purification process, 10 or more patients are viewed. For that purpose, more than 100 confirmation work is actually required. Therefore, it is strongly desired to make the blood purification process simpler and reduce the work load. If the work load can be reduced, it will not only improve work efficiency but also prevent errors.

However, as described in Patent Document 1, in the conventional embodiment in which the replacement fluid is supplied to the blood circuit or the drip chamber on the blood circuit, the replacement fluid inlet tubular member itself or the replacement fluid inlet tubular member is connected to the blood circuit or the drip. A connecting member for connecting to the chamber is required, which increases the number of parts and complicates the blood circuit.

In addition, since the blood circuit including the drip chamber and the connecting member comes into contact with the patient's blood, it is discarded after each blood purification process. Therefore, there is also a problem that an increase in the number of parts of the blood circuit is economically unfavorable.

In the blood purification apparatus described in Reference 2, a salt water tube (98) is provided in the arterial blood reservoir (46) in the cartridge (42). However, the blood tube set (BTS) including the cartridge (42) is a special component different from the blood purifier, the number of components is hardly reduced, and the manufacturing cost is still high. Further, such a blood tube set (BTS) is disposable, is connected to a blood purifier and a blood purifying device before the blood purification treatment, and needs to be removed after the blood purification treatment (Cited Document 2 No. 2). 8th page, 25th to 26th lines, and 32nd to 34th lines), which also does not lead to a reduction in work load.

The present invention can simplify the blood circuit and thus contribute to more error prevention, reduce the manufacturing cost due to the small number of parts, and reduce the number of parts to be discarded in each blood purification process, which is economical. It also aims to provide an excellent blood purifier.

As a result of diligent studies to solve the above problems, the inventors of the present application, contrary to the tendency of the conventional blood purifier to add special and complicated parts, the arterial end of the blood purifier and / Alternatively, they have found that the above problems can be solved by providing a replacement fluid inlet at the venous end, and have completed the present invention. That is, the present invention is as follows.
[1] A blood purifier for purifying extracorporeal circulating blood, wherein the blood purifier has an arterial end having a blood inlet, a single blood purifying unit for purifying extracorporeal circulating blood, and a blood outlet. A blood purifier having a venous side end having a venous side end, and further having a replenishment inlet for supplying a replenishing solution to the extracorporeal circulating blood at the arterial side end and / or the venous side end.
[2] The item [1], further comprising a mixing means for uniformly mixing the extracorporeal circulating blood and the replacement fluid flowing in from the replacement fluid inlet at the arterial side end and / or the vein side end. Blood purifier.
[3] The blood purifier according to item [1] or [2], wherein the blood purifier is a hemodialyzer that purifies blood by bringing dialysate into contact with the extracorporeal circulating blood.
[4] The blood purifier is a hollow fiber hemodialyzer that purifies blood by contacting the extracorporeal circulating blood flowing inside the hollow fiber with a dialysate flowing outside the hollow fiber. Item [3] The blood purifier described in.
[5] The blood purifier according to item [3] or [4], which is used together with an online blood purifier that supplies the dialysate as a replacement fluid to the extracorporeal circulating blood.
[6] Items [1] to [5] having an internal space having a predetermined capacity at the arterial side end and / or the vein side end to capture the gas mixed or generated during blood purification. ] The blood purifier according to any one of the items.
[7] The pressure of at least one replacement fluid supply flow path for directly supplying the replacement fluid to the replacement fluid inlet and the pressure of the replacement fluid flowing through the replacement fluid supply flow path for detecting an abnormality in the flow of extracorporeal blood is measured. The blood purifier according to any one of items [1] to [6], which is used together with a reusable blood purification device having a replacement fluid pressure measuring means.
[8] The blood purifier according to any one of items [1] to [7], further comprising a replacement fluid inlet tubular member connected to the replacement fluid inlet.

Since the blood purifier of the present invention has the above-mentioned configuration, it is possible to reduce the work load required for connecting the equipment before the blood purification treatment and removing the equipment after the blood purification treatment, and therefore more error prevention. In addition, since the number of parts is small, the manufacturing cost is reduced, and less parts are discarded in each blood purification treatment, which is economical.

FIG. 1 is a schematic view showing a blood purifier according to an embodiment of the present invention. FIG. 2 is a schematic view showing a cross section of a blood purifier according to a preferred embodiment of the present invention. FIG. 3 is a schematic view showing a blood purifier according to a preferred embodiment of the present invention and a blood purifier used together with the blood purifier. FIG. 4 is a schematic diagram showing a blood circuit used together with a conventional blood purifier.

Hereinafter, the blood purifier according to the embodiment of the present invention (hereinafter, referred to as “the present embodiment”) will be described in detail with reference to the drawings, but the present invention is not limited to the present embodiment.

《Blood purifier》
FIG. 1 is a schematic view showing a blood purifier according to an embodiment of the present invention. The blood purifier of the present embodiment is a blood purifier (200) that purifies extracorporeal circulating blood, and the blood purifier has an arterial side end (201) having a blood inlet (203) and the extracorporeal circulation. It has a single blood purifying section (216) for purifying blood and a venous side end (202) having a blood outlet (204), at the arterial side end and / or the venous side end. It also has a replenishment inlet (207) for supplying replenishment to extracorporeal circulating blood.

FIG. 4 is a schematic diagram showing a blood circuit used together with a conventional blood purifier. In the specification of the present application, the term "blood circuit" is used as a general term for a blood inlet tubular member and a blood outlet tubular member. Conventionally, a replacement fluid inlet tubular member is connected to a blood circuit or a drip chamber on the blood circuit to supply replacement fluid to extracorporeal circulating blood. For example, in the blood circuit shown in FIG. 4, the replacement fluid inlet tubular member (405) is connected to the blood inlet tubular member (401) and the drip chamber (403) provided on the blood outlet tubular member (402). .. Therefore, the replacement fluid inlet tubular member itself and a connecting member (407) such as a T-shaped tube connecting the tubular member itself are required, and the number of parts increases and the blood circuit becomes complicated.

On the other hand, the blood purifier of the present embodiment has, for example, as shown in FIG. 1, a replacement fluid inlet for supplying replacement fluid to extracorporeal circulating blood at the arterial side end and / or the vein side end. As a result, the fluid replacement inlet tubular member on the blood circuit shown in FIG. 4 and the connecting member for connecting the tubular member, which have been conventionally required, are no longer required, and the blood circuit is further simplified. Therefore, the blood purifier of the present embodiment further contributes to the prevention of errors, the number of parts is small, the manufacturing cost is reduced, and the number of parts discarded in each blood purification treatment is small, which is economical. ..

Here, in the specification of the present application, the "arterial side end portion" is a portion of the blood purifier having a function of substantially purifying extracorporeal circulating blood (hereinafter, also referred to as a "blood purifying portion" in the figure. 216) refers to the portion upstream of the blood purifier, and the "venous end" refers to the portion of the blood purifier that is downstream of the blood purifier. The arterial side end and the vein side end may be parts different from the main body container, for example, a lid or the like, or may be a part formed integrally with the main body container. The shape of the main container of the blood purifier is not particularly limited, and is, for example, a tubular shape, typically a cylindrical shape.

As schematically shown in FIGS. 1 and 2, the blood purification unit (216) is single in this embodiment. Here, the "single" blood purification unit means that a portion having a function of substantially purifying extracorporeal circulating blood is continuous without being separated by a substance-impermeable member. More preferably, the portion capable of purifying substantially extracorporeal circulating blood is used for substantially the same purpose throughout the blood purifying section; can provide substantially the same function; and / or substantially. It is composed of a uniformly uniform material. In one embodiment, the portion having the function of substantially purifying the extracorporeal circulating blood is a bundle of hollow fibers. More preferably, the bundle of hollow fibers is used for substantially the same purpose throughout the blood purification section; can provide substantially the same function; and / or is composed of a substantially uniform material. There is. The blood purifier of the present embodiment can simplify the blood purification system by having a fluid replacement inlet at the arterial end and / or the venous end and a single blood purification unit. Therefore, it contributes more to the prevention of errors, the number of parts is small, the manufacturing cost is reduced, and less parts are discarded in each blood purification treatment, which is economical.

In one embodiment, a single blood purifier is located between the arterial and venous ends, as schematically shown in FIGS. 1 and 2. Therefore, it is preferable that the replacement fluid inlet exists upstream and / or downstream of the flow of extracorporeal circulating blood, and does not exist in the middle of the blood purification unit, rather than a single blood purification unit.

In one embodiment, the blood purifier of the present embodiment is preferably used together with a blood purification device having at least one fluid replacement flow path for directly supplying fluid replacement to the fluid replacement inlet. The "replenishment fluid supply flow path that directly supplies the replacement fluid to the replacement fluid inlet" is configured so that an abnormality in the flow of extracorporeal blood can be detected by measuring the replacement fluid pressure by a replacement fluid pressure measuring means described later. It is intended to be a flow path. Therefore, if, but not limited to, a fluid replacement pump, an optional fluid replacement means, or the like is provided before the fluid reaches the flow of extracorporeal circulating blood in the replacement fluid supply flow path, the fluid replacement pressure measuring means is provided through these. Even if it is provided, abnormalities in the flow of extracorporeal blood cannot be detected due to pressure. Therefore, for example, a portion where an abnormality in the flow of extracorporeal blood cannot be detected even if a replacement fluid pressure measuring means is provided, such as a portion upstream of the fluid replacement pump and / or any replacement fluid filtration means with respect to the replacement fluid inlet. It does not correspond to "the replacement fluid is directly supplied to the replacement fluid inlet ... the replacement fluid supply flow path". The portion downstream of them and upstream of the replacement fluid inlet corresponds to "directly supplying replacement fluid ... replacement fluid supply flow path". When the blood purifier of the present embodiment is used in combination with a blood purification device having such a "replenishment fluid directly supplied to the replacement fluid inlet ... replacement fluid supply flow path" in addition to having a single blood purification unit. The blood purification system can be simplified, thus contributing to error prevention, the number of parts is reduced, the manufacturing cost is reduced, and less parts are discarded for each blood purification process, which is economical. ..

<Blood inlet and blood outlet>
The blood purifier of the present embodiment has a blood inlet at the arterial end and a blood outlet at the venous end, and is capable of passing extracorporeal circulating blood. During the blood purification process, a blood inlet tubular member is connected to the blood inlet, and a blood outlet tubular member is connected to the blood outlet to form a blood circuit, and extracorporeal circulating blood can flow.

<Infusion inlet>
The blood purifier of the present embodiment may have a replacement fluid inlet at at least one of its arterial end and venous end (FIGS. 1 (i) or (ii)). This eliminates the need for the replacement fluid inlet tubular member (405) and its connecting member (407) in at least one of the blood inlet tubular member and the blood outlet tubular member, so that the blood circuit can be simplified and contributes to error prevention. And it is economical.

The blood purifier of the present embodiment preferably has fluid replacement inlets at both the arterial and venous ends (FIG. 1 (iii)). This eliminates the need for the replacement fluid inlet tubular member (405) and its connecting member (407) in both the blood inlet tubular member and the blood outlet tubular member, so that the blood circuit can be further simplified and contributes to the prevention of errors. , Excellent in economy. In addition, a blood purifier having fluid replacement inlets at both the arterial and venous ends can be used by itself for both pre-dilution and post-dilution blood purification treatments, and is therefore versatile. Is high.

A blood circuit having no replacement fluid inlet may be used, a blood circuit having a replacement fluid inlet may be used, or a combination thereof may be used together with the blood purifier of the present embodiment. That is, with respect to the three types of blood purifiers (FIGS. 1 (i), (ii) and (iii)) having a replacement fluid inlet at the arterial end and / or the venous end of the present embodiment, respectively. A combination of two blood inlet tubular members with or without a replacement fluid inlet and two blood outlet tubular members with or without a replacement fluid inlet can be considered.

For example, a blood purifier having a replacement fluid inlet at the end of the artery (FIG. 1 (i)), a blood inlet tubular member having no replacement fluid inlet, and a blood outlet tubular member having a replacement fluid inlet may be used in combination. May be good. In this case, the blood inlet tubular member can be simplified, which contributes to the prevention of errors and is excellent in economy. In addition, it is highly versatile because it can be used for both pre-dilution and post-dilution blood purification treatments. Alternatively, a blood purifier having a replacement fluid inlet at the venous end (FIG. 1 (ii)), a blood inlet tubular member having a replacement fluid inlet, and a blood outlet tubular member having no replacement fluid inlet may be used in combination. May be good. In this case, the blood outlet tubular member can be simplified, which contributes to the prevention of errors and is excellent in economy. In addition, it is highly versatile because it can be used for both pre-dilution and post-dilution blood purification treatments.

As another example, it is preferable to use a blood purifier (FIG. 1 (iii)) having a replacement fluid inlet at both the arterial end and the venous end in combination with a blood circuit having no replacement fluid inlet. .. In this case, both the blood inlet tubular member and the blood outlet tubular member can be simplified, which contributes to the prevention of errors and is excellent in economy. In addition, it is highly versatile because it can be used for both pre-dilution and post-dilution blood purification treatments.

<Tubular member of fluid replacement inlet>
The blood purifier of the present embodiment may further include a replacement fluid inlet tubular member connected to a replacement fluid inlet at the arterial and / or venous end. The replacement fluid inlet tubular member is connected to the replacement fluid supply flow path of the blood purification device at the time of use, and can flow the replacement fluid.

Extracorporeal circulation If the blood purifier further has a fluid replacement tubular member connected to the replacement fluid inlet at the arterial and / or venous end, extracorporeal circulation due to pulsation of a pump that pumps extracorporeal blood. It is possible to effectively prevent blood from flowing into the replacement fluid supply flow path of the blood purification device. Therefore, the risk of cross-infection and the like when the blood purification device is repeatedly used can be effectively reduced.

When fluid replacement inlet tubular members are connected to the replacement fluid inlets at the arterial and venous ends of the blood purifier, the fluid replacement inlet tubular members are connected together to form a closed fluid replacement circuit before use. You may. When the replacement fluid inlet tubular member constitutes a closed replacement fluid circuit, it is possible to effectively prevent the invasion of pollutants such as bacteria into the blood purifier during transportation and storage. In this case, the fluid replacement inlet tubular members are disconnected from each other at the time of use and connected to the replacement fluid supply flow path of the blood purification device, so that the replacement fluid flows.

<Mixing means>
The blood purifier of the present embodiment may further have a mixing means at the arterial side end and / or the venous side end for uniformly mixing the extracorporeal circulating blood and the replacement fluid flowing in from the replacement fluid inlet. ..

Since the arterial end has a mixing means, the mixing of extracorporeal circulating blood and replacement fluid is promoted, blood can be purified more uniformly, and the effect of reducing the functional deterioration of the blood purifier is also expected. can. By having the mixing means at the venous side end, mixing of extracorporeal circulating blood and replacement fluid is promoted, and the burden on the patient can be reduced.

The mixing means is not particularly limited, and a person skilled in the art can select any suitable means. For example, as the mixing means, it is preferable that the mixing means does not have a driving unit from the viewpoint of safety, ease of manufacturing, and the like. Examples of the mixing means having no drive unit include providing obstacles such as a baffle plate and protrusions, and providing a structure generally called a static mixer. It should be noted that such a mixing means does not exclude the mode in which the blood and the replacement fluid are mixed in combination with the shape of the replacement fluid inlet and the shape of the end portion.

<Internal space>
Even if the blood purifier of the present embodiment has an internal space having a predetermined capacity at the arterial side end and / or the vein side end, which can capture the gas mixed or generated during blood purification. good.

Conventionally, as shown in FIG. 4, a drip chamber (403) is provided on a blood inlet tubular member and / or a blood outlet tubular member so that gas does not flow into the patient's body, and is mixed or generated during blood purification. It was necessary to capture the gas. In particular, the drip chamber on the blood outlet tubular member was important because the blood outlet tubular member allows blood to return to the patient's body to flow. On the other hand, in the present embodiment, the arterial side end and / or the vein side end of the blood purifier has the above-mentioned internal space, so that the drip chamber shown in FIG. 4, which has been conventionally required, is provided. It is no longer necessary, the blood circuit is simplified, the work load can be reduced, and it contributes to the prevention of errors. In addition, the contact between blood and air is reduced, and blood coagulation is reduced. Further, since the number of parts is small, the manufacturing cost is reduced, the number of parts discarded in each blood purification treatment can be reduced, and the economy is more excellent.

The predetermined capacity is not limited to the following, but can be, for example, 5 cc or more and 30 cc or less.

<Drug inlet>
The blood purifier of the present embodiment may further have a drug inlet (not shown) at the arterial end. During blood purification treatment, an anticoagulant may be added to prevent coagulation of extracorporeal circulating blood due to contact between blood and air. Conventionally, a drug inlet (not shown) has been provided in a tubular member for blood inlet or the like. On the other hand, in the present embodiment, when the drug inlet is further provided at the arterial end of the blood purifier, the conventional drug inlet is not required, the blood circuit is further simplified, and it contributes to the prevention of errors.

<Type of blood purifier>
In the present embodiment, the type of blood purifier is not particularly limited as long as it can purify blood. In the specification of the present application, "blood purification" (also referred to as "blood purification treatment") refers to a treatment including removing excess water, waste products, etc. from the blood. Principles for removing excess water, waste products, etc. from blood include diffusion, filtration, adsorption, and the like. In the present embodiment, the blood purification treatment includes, but is not limited to, diffusion, filtration, adsorption, and purification by a combination thereof, and the blood purifier of the present embodiment is used for any blood purification treatment. be able to.

The blood purifier of the present embodiment may be an adsorption type blood purifier that purifies the blood by bringing the extracorporeal circulating blood into contact with the adsorbent.

The blood purifier of the present embodiment may be a hemofilter that purifies the blood by filtering the extracorporeal circulating blood.

The blood purifier of the present embodiment may be a hemodialyzer that purifies blood by bringing dialysate into contact with extracorporeal circulating blood. Hemodialyzers can purify blood using the principle of diffusion or in combination with filtration with diffusion. In the specification of the present application, the term "hemodialysis device" includes a so-called "hemodiafiltration device" that purifies blood by combining filtration with diffusion.

When the blood purifier of the present embodiment is a blood dialyzer that purifies blood by bringing dialysate into contact with extracorporeal circulating blood, the blood dialyzer has a dialysate inlet and a dialysate outlet (not shown in FIG. 1). May further have. For example, the main container of the hemodialyzer can be provided with a dialysate inlet and a dialysate outlet, typically on the side surface of the main body container.

The blood purifier of the present embodiment may be a hollow fiber hemodialyzer that purifies blood by contacting the extracorporeal circulating blood flowing inside the hollow fiber with a dialysate flowing outside the hollow fiber.

《Blood purification device》
The blood purifier of the present embodiment can be used together with a blood purifying device capable of supplying a replacement fluid to extracorporeal circulating blood.

Blood purifiers are generally reusable. Here, "repeated use" means that it can be used for blood purification treatment two or more times, but it does not exclude that it is used only once by the user's choice. In the specification of the present application, the blood purification device can be distinguished from a blood purifier that is disposable for each blood purification treatment, a disposable part associated therewith, and the like in that the blood purification device can be used repeatedly.

<Replenishment fluid supply flow path>
The blood purification device used together with the blood purifier of the present embodiment is at least one fluid replacement flow path for supplying fluid replacement to the fluid replacement inlet provided at the arterial end and / or the venous end of the blood purifier. It may have. The replacement fluid supply flow path is connected to the replacement fluid inlet of the blood purifier during use so that the replacement fluid can flow.

There may be two systems of replacement fluid supply channels of the blood purification device used together with the blood purifier of the present embodiment. Since there are two fluid replacement flow paths in the blood purification device, one system can supply fluid replacement to the extracorporeal circulating blood before purification, and the other system can supply fluid replacement to the extracorporeal circulating blood after purification. can. Therefore, the supply position of the replacement fluid can be appropriately switched according to the purpose and stage of the blood purification treatment, which enhances versatility and convenience.

In addition, since the blood purification device has two fluid replacement flow paths, the priming work of filling the blood purifier side with fluid replacement before the blood purification treatment and the blood remaining in the blood purifier after the blood purification treatment are collected. It has the following advantages in blood collection work. That is, when performing priming, it is possible to collect the replacement fluid and the like in the blood circuit from the other system while supplying the replacement fluid and the like from one system, so that it is easy to recover the replacement fluid and the like without reconnecting the blood circuit. Can be primed. Further, at the time of blood collection, by supplying the replacement fluid from one system for supplying the replacement fluid to the extracorporeal circulating blood before purification, the blood can be easily collected without reconnecting the blood circuit. Further, the priming line (406) shown in FIG. 4 and the connecting member (407) associated therewith, which have been conventionally required, are no longer required, and the blood circuit is simplified.

When the blood purification device has two fluid replacement fluid supply channels, the fluid replacement fluid supply channels may each have independent fluid feeding means. When the replacement fluid supply flow path has an independent liquid feeding means, the blood purification device can appropriately set the supply amount of the replacement fluid according to the purpose and stage of the blood purification treatment, so that it is versatile and convenient. It gets higher.

The replacement fluid is not limited as long as it is a liquid supplied to the extracorporeal circulating blood, and examples thereof include physiological saline. In the blood purification treatment using a dialysate, the dialysate may be supplied as a replacement fluid as described later.

The replacement fluid supply source may be a container provided in the blood purification device, or may be a supply source provided separately from the blood purification device, for example, a bottle containing a replacement fluid or a replacement fluid bag. The liquid feeding means for feeding the replacement fluid is not limited, and any liquid feeding pump, for example, a tubing pump can be used.

<Fluid replacement pressure measuring means>
The blood purification device used together with the blood purifier of the present embodiment has at least one replacement fluid supply flow path for directly supplying the replacement fluid to the replacement fluid inlet, and a replacement fluid supply flow for detecting an abnormality in the flow of extracorporeal blood. It may be a blood purification device having a replacement fluid pressure measuring means for measuring the pressure of the replacement fluid flowing through the path.

As shown in FIG. 4, conventionally, a tubular member for pressure measurement (404) is connected to a drip chamber (403) provided on a blood circuit in order to detect an abnormality in blood flow. This tubular member for pressure measurement is connected to the upper part of the drip chamber so as not to come into contact with blood, and communicates with the gas phase in the drip chamber. Conventionally, at the time of use, a pressure measuring device (not shown) is connected to a tubular member for pressure measuring, and an abnormality in the flow of extracorporeal blood is detected through the gas phase in the drip chamber. Therefore, conventionally, the pressure measuring tubular member itself, the connecting member (407) for attaching the pressure measuring tubular member, and the like have been required. Further, it is necessary to connect the pressure measuring device to the tubular member for pressure measurement before the blood purification treatment and remove it after the blood purification treatment, which increases the work load.

Further, conventionally, the pressure measuring tubular member (404) has been used to prevent contaminants such as bacteria from entering the blood circuit from the pressure measuring means, and blood or the like leaks from the blood circuit to the pressure measuring means side. It has a hydrophobic filter (408) to prevent it. If the hydrophobic filter gets wet, the pressure inside the drip chamber cannot be measured, so care must be taken not to get the hydrophobic filter wet before the blood purification treatment, and hydrophobicity during the blood purification treatment. It was necessary to monitor the filter so that it would not get wet. However, due to improper connection of the blood circuit or the like, the air in the gas phase in the drip chamber may leak, and the hydrophobic filter may get wet with the blood or fluid replacement in the blood circuit. And once the hydrophobic filter got wet, it had to be replaced with a new blood circuit, which increased the workload.

On the other hand, the blood purification device has at least one replacement fluid supply flow path for directly supplying the replacement fluid to the replacement fluid inlet, and a replacement fluid flowing through the replacement fluid supply flow path for detecting an abnormality in the flow of extracorporeal blood. By having the replacement fluid pressure measuring means for measuring the pressure, the tubular member for pressure measuring shown in FIG. 4, the connecting member associated therewith, the hydrophobic filter, etc., which were conventionally required, are no longer required, and the blood circuit is further simplified. NS. Further, since the pressure of the supplementary liquid which is a liquid can be measured without going through the gas phase of the drip chamber, it is not necessary to provide the gas phase for pressure measurement in the drip chamber in advance, and the blood and the gas phase. The contact area with can be reduced. Therefore, it is possible to reduce the work load on the connection of the equipment before the blood purification treatment, the removal of the equipment after the blood purification treatment, and the handling of the hydrophobic filter. Contact with air is reduced, blood coagulation is reduced, manufacturing costs are reduced due to the small number of parts, and fewer parts are discarded in each blood purification process, which is economical.

In the specification of the present application, the "direct supply of replacement fluid ... replacement fluid supply flow path" to the extracorporeal circulating blood means that an abnormality in the flow of extracorporeal circulating blood can be detected by measuring the pressure of the replacement fluid by a replacement fluid pressure measuring means. It is intended to be a flow path configured to allow it. Therefore, although not limited, when the replacement fluid supply flow path has a fluid replacement pump, an arbitrary replacement fluid filtration means, etc., even if the replacement fluid pressure measuring means is provided via these, abnormalities in the flow of extracorporeal circulating blood are detected by the pressure. Can't. Therefore, for example, a portion where an abnormality in the flow of extracorporeal blood cannot be detected even if a replacement fluid pressure measuring means is provided, such as a portion upstream of the fluid replacement pump and / or any replacement fluid filtration means with respect to the replacement fluid inlet. It does not correspond to "direct supply of replacement fluid ... replacement fluid supply flow path". The portion downstream from them and upstream from the replacement fluid inlet corresponds to "direct supply of replacement fluid ... replacement fluid supply flow path".

The position of the replacement fluid pressure measuring means is not particularly limited as long as it is on the replacement fluid supply flow path for directly supplying the replacement fluid to the extracorporeal circulating blood of the blood purification device. When the replacement fluid supply flow path for directly supplying the replacement fluid to the extracorporeal circulating blood extends to the outside of the housing of the blood purification device, the replacement fluid pressure measuring means is installed outside the housing of the blood purification device. May be good.

As the replacement fluid pressure measuring means, any pressure gauge can be used as long as the pressure of the replacement fluid which is a liquid can be measured. The replenishment pressure measuring means is not limited to the following; elastic pressure gauges such as Bourdon tube pressure gauge, diaphragm pressure gauge, bellows pressure gauge, chamber pressure gauge; and inelastic pressure gauges such as liquid column pressure gauge and Examples include a weight pressure gauge.

Whether or not the flow of extracorporeal circulating blood is abnormal can be appropriately determined by a person skilled in the art according to the patient, the conditions of blood purification treatment, and the like. For example, when the pressure of the replacement fluid fluctuates by a predetermined value or more from the value in the steady state, it can be determined that the blood flow is abnormal. The blood purification device may further include a control device that automatically determines whether or not the flow of extracorporeal circulating blood is abnormal. The control device may provide a display to notify the operator when it is determined that the extracorporeal circulating blood flow is abnormal.

<Dialysate supply flow path and dialysate recovery flow path>
The blood purification device used together with the blood purifier of the present embodiment has a dialysate supply flow path for supplying dialysate to the blood purifier and a dialysate recovery flow path for collecting dialysate from the hemodialyzer. You may also have. By further providing a dialysate supply flow path for supplying dialysate to the blood purifier and a dialysate recovery flow path for recovering dialysate from the hemodiadialyzer, the blood purifier is based on HD, HDF, etc. It can also be used for hemodialysis treatment, increasing its versatility.

The blood purifying device used together with the blood purifying device of the present embodiment may be an online blood purifying device that supplies dialysate to extracorporeal circulating blood as a replacement fluid. The blood purification process of supplying dialysate to extracorporeal circulating blood as a replacement fluid is also commonly referred to as an "online" blood purification process. Further, a blood purification process in which a fluid replacement source is provided separately from the blood purification device, for example, supplying a replacement fluid in a bottle or a replacement fluid bag, is also commonly referred to as an "offline" blood purification process. The blood purification device can also be used for online blood purification treatment when the replacement fluid supply channel is branched from the dialysate supply channel and the dialysate can be supplied to the extracorporeal circulating blood as a replacement fluid. , High versatility.

The dialysate is not particularly limited as long as it can be brought into contact with extracorporeal circulating blood to remove excess water, waste products, and the like from the blood. Examples of the dialysate include physiological saline. The dialysate may be used as a replacement fluid. The means for delivering the dialysate is not limited, and any liquid feeding pump, for example a tubing pump, can be used.

<< Embodiment >>
Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited to the following preferred embodiments.

FIG. 2 is a schematic view showing a cross section of a blood purifier according to a preferred embodiment of the present invention. In FIG. 2, the blood purifier (200) has a bundle of hollow fibers (209) as a single blood purification unit (216) in a cylindrical main body container (208), and the bundle of hollow fibers is the bundle thereof. Both ends are fixed in the cylindrical main body container by a sealing member (210), and the inside and the outside of the hollow fiber are separated from each other. For the sake of explanation, only a part of the bundle of hollow fibers is described.

The tubular body container has an arterial side end (201) having a blood inlet (203) and a replacement fluid inlet (207) and a venous side end having a blood outlet (204) and a replacement fluid inlet (207) at both ends thereof. (202) and. During use, a blood inlet tubular member (not shown) is connected to the blood inlet and a blood outlet tubular member (not shown) is connected to the blood outlet to form a blood circuit and extracorporeally inside the hollow fiber. Circulating blood (300) can flow. Further, a replacement fluid inlet tubular member (215) is connected to each of the replacement fluid inlets, and the replacement fluid inlet tubular member is connected to two systems of replacement fluid supply channels (101) of the blood purification device (100) at the time of use. And the replacement fluid can be flushed. The main body container has a dialysate inlet (211) and a dialysate outlet (212) on its side surface, and when used, the dialysate is placed in a space surrounded by the outside of the hollow thread, the inside of the main body container, and the sealing member. The extracorporeal circulating blood can be brought into contact with the dialysate via the hollow thread.

In addition, the blood purifier has a mixing means (213) inside the end on the arterial side, so that the extracorporeal circulating blood and the replacement fluid flowing in from the replacement fluid inlet are uniformly mixed before the blood passes through the inside of the hollow fiber. Can be mixed. Further, the blood purifier has an internal space (214) having a predetermined capacity at the arterial end and the venous end, which can capture the gas mixed or generated during blood purification.

FIG. 3 is a schematic view of a blood purifier according to a preferred embodiment of the present invention and a blood purifier used together with the blood purifier. In FIG. 3, the blood purifying device (100) is a reusable blood purifying device used together with a blood purifying device (200) that purifies blood by bringing dialysate into contact with extracorporeal circulating blood (300). The blood purification device has two replacement fluid supply channels (101) for directly supplying the replacement fluid to the extracorporeal circulating blood, and the two replacement fluid supply channels each have an independent fluid delivery pump (106). It has and can independently control the flow rate of the replacement fluid. The blood purification device has a replacement fluid pressure measuring means (102) on each replacement fluid supply flow path for measuring the pressure of the replacement fluid flowing through the replacement fluid supply flow path for detecting an abnormality in the flow of extracorporeal blood. .. Further, the blood purification device further has a dialysate supply flow path (103) for supplying dialysate to the hemodialyzer and a dialysate recovery flow path (104) for recovering the dialysate from the hemodialyzer. doing. Each of the two fluid replacement fluid supply channels is branched from the dialysate supply channel, and therefore, the blood purification device (100) supplies the dialysate from the dialysate supply source (105) to the extracorporeal circulating blood as a replacement fluid. It is an online blood purification device that can be used.

According to a preferred embodiment of the present invention, a fluid replacement inlet tubular member (405), a pressure measuring tubular member (404), a drip chamber (403), and a priming line, which are required in a conventional blood circuit as shown in FIG. (406), the hydrophobic filter (408), and the connecting member (407) associated therewith are not required. In addition, abnormalities in the flow of extracorporeal blood can be directly detected by measuring the pressure of the replacement fluid, which is a liquid. Therefore, the blood purifier according to the preferred embodiment of the present invention can further reduce the work load on connecting the equipment before the blood purification treatment, removing the equipment after the blood purification treatment, handling the hydrophobic filter, and the like. Therefore, it contributes more to the prevention of errors, reduces the contact between blood and air, reduces blood coagulation, reduces the manufacturing cost due to the small number of parts, and disposes of parts for each blood purification process. It can be seen that it is less economical and more economical.

100 Blood purification device 101 Supplementary solution supply flow path 102 Supplementary solution pressure measuring means 103 Dialysate supply flow path 104 Dialysate recovery flow path 105 Supplementary solution (dialysate) supply source 106 Liquid transfer pump 200 Blood purifier 201 Arterial side end 202 Intravenous side End 203 Blood inlet 204 Blood outlet 207 Supplementary fluid inlet 208 Main body container 209 Hollow thread bundle 210 Sealing member 211 Dialysate inlet 212 Dialysate outlet 213 Mixing means 214 Internal space 215 Supplementary fluid inlet Tubular member 216 Blood purification unit 300 Extracorporeal circulating blood 400 Blood circuit 401 Blood inlet tubular member 402 Blood outlet tubular member 403 Drip chamber 404 Pressure measurement tubular member 405 Replenishment inlet tubular member 406 Priming line 407 Connecting member 408 Hydrophobic filter

Claims (7)

A blood purifier that purifies extracorporeal circulating blood
The blood purifier has an arterial side end having a blood inlet, a single blood purifying part for purifying the extracorporeal circulating blood, and a venous side end having a blood outlet.
Wherein the arterial end and the vein side end portion, the extracorporeal circulation further have a replacement fluid inlet for supplying a replacement fluid, further comprising a replacement fluid inlet tubular member connected to each of the replacement fluid inlet, using In the foreground, a blood purifier in which the replacement fluid inlet tubular members are connected together to form a closed fluid replacement circuit. The blood purifier according to claim 1, further comprising a mixing means for uniformly mixing the extracorporeal circulating blood and the replacement fluid flowing in from the replacement fluid inlet at the arterial side end and / or the vein side end. .. The blood purifier according to claim 1 or 2, wherein the blood purifier is a hemodialyzer that purifies blood by bringing dialysate into contact with the extracorporeal circulating blood. The blood according to claim 3, wherein the blood purifier is a hollow fiber hemodialyzer that purifies blood by contacting an extracorporeal circulating blood flowing inside the hollow fiber with a dialysate flowing outside the hollow fiber. Purifier. The blood purifier according to claim 3 or 4, which is used together with an online blood purifier that supplies the dialysate as a replacement fluid to the extracorporeal circulating blood. Any one of claims 1 to 5, wherein the arterial end and / or the venous end has an internal space having a predetermined volume capable of capturing a gas mixed or generated during blood purification. The blood purifier described in. Fluid replacement pressure measurement for measuring the pressure of at least one fluid replacement fluid supply channel for directly supplying the fluid replacement fluid to the fluid replacement inlet and the fluid replacement fluid flowing through the fluid replacement fluid supply channel for detecting an abnormality in the flow of extracorporeal blood. The blood purifier according to any one of claims 1 to 6, which is used together with a blood purification device having a means.

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