Blood purification device

Abstract

To provide a blood purification device capable of preventing connection of a chamber member from being forgotten when switching a needle state to a single needle state for executing blood purification treatment.SOLUTION: A blood purification device capable of arbitrarily switching a needle state between a double need state and a single needle state includes: a blood pump 4; a fed liquid amount detection part 11 for detecting a fed liquid amount of liquid by the drive of the blood pump 4; a pressure detection part 6 for detecting the pressure in a blood circuit; a chamber member 9 connected to an air trap chamber 5 in the single needle state for causing blood in the blood circuit to flow in and pooling the blood in a blood collection phase for collecting blood from a patient, and for causing the pooled blood to outflow to the blood circuit and returning the blood in a blood returning phase for returning the blood to the patient; and a connection determination part 12 for determining presence or absence of the connection of the chamber member 9 on the basis of the fed liquid amount detected by the fed liquid amount detection part 11 and the pressure detected by the pressure detection part 6.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a blood purification device that performs blood purification treatment while extracorporeal circulation of a patient's blood.

Background Art

[0002] Generally, during blood purification treatment, a blood circuit for extracorporeal circulation of the collected patient's blood and then returning it to the body again is used. Such a blood circuit is mainly composed of an arterial side blood circuit and a venous side blood circuit that can be connected to a dialyzer (blood purifier) equipped with, for example, a hollow fiber membrane (blood purification membrane). Then, blood purification treatment is performed by purifying the patient's blood in the extracorporeal circulation in the blood circuit with the dialyzer.

[0003] However, conventionally, as disclosed in, for example, Patent Document 1, a double-needle state in which an arterial side puncture needle and a venous side puncture needle are respectively attached to the tips of the arterial side blood circuit and the venous side blood circuit, and a single-needle state in which a single puncture needle is attached to the tips of the arterial side blood circuit and the venous side blood circuit via a Y-tube are arbitrarily switchable blood purification devices have been proposed.

[0004] In such a conventional blood purification device, a single-needle chamber is connected to a bubble separation chamber, and a single-needle valve is disposed between these bubble separation chamber and single-needle chamber. Thereby, when performing blood purification treatment in the double-needle state, the single-needle valve is closed and blood is circulated extracorporeally, and when switching from the double-needle state to the single-needle state and continuing blood purification treatment, the single-needle valve is opened to communicate the single-needle chamber with the bubble separation chamber, whereby blood can be stored in the single-needle chamber.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] However, in the above conventional blood purification device, when performing blood purification treatment by switching from the double-needle state to the single-needle state, it is necessary to control the single-needle valve in order to communicate the single-needle chamber with the bubble separation chamber. For this reason, the applicant of the present application has considered eliminating the single-needle valve by connecting a chamber member capable of storing blood when performing blood purification treatment by switching from the double-needle state to the single-needle state.

[0007] However, when configured to connect the chamber member when switching to the single-needle state and performing blood purification treatment in this way, although the single-needle valve can be eliminated, the presence or absence of connection of the chamber member cannot be detected by the blood purification device and must be confirmed solely by visual inspection by medical staff. Therefore, there is a risk that blood purification treatment will be performed in the single-needle state with the chamber member not connected.

[0008] The present invention has been made in view of such circumstances, and an object thereof is to provide a blood purification device capable of preventing forgetting to connect a chamber member when performing blood purification treatment by switching to the single-needle state.

Means for Solving the Problems

[0009] A blood purification device according to an embodiment of the present invention extracorporeally circulates a patient's blood through a blood circuit having an arterial side blood circuit and a venous side blood circuit and a blood purifier, purifies the blood, and has a double-needle state in which an arterial side puncture needle and a venous side puncture needle are respectively attached to the tips of the arterial side blood circuit and the venous side blood circuit, and a single-needle state in which a single puncture needle is attached to the tips of the arterial side blood circuit and the venous side blood circuit via a Y-tube. The blood purification device is arbitrarily switchable, and includes a blood pump that pumps a liquid in the blood circuit, a liquid feed amount detection unit that detects the liquid feed amount of the liquid driven by the blood pump, a pressure detection unit that detects the pressure in the blood circuit, and when in the single-needle state, it is connected downstream of the arrangement position of the blood pump in the blood circuit, and in the blood collection phase of collecting blood from the patient, the blood in the blood circuit flows in and is stored, and in the blood return phase of returning blood to the patient, the stored blood flows out of the blood circuit and is returned. A chamber member, and a connection determination unit that determines the presence or absence of connection of the chamber member based on the liquid feed amount detected by the liquid feed amount detection unit and the pressure detected by the pressure detection unit.

Effects of the Invention

[0010] According to the present invention, since the presence or absence of connection of the chamber member is determined based on the liquid feed amount detected by the liquid feed amount detection unit and the pressure detected by the pressure detection unit, when performing blood purification treatment in the single-needle state, it is possible to prevent forgetting to connect the chamber member.

Brief Description of the Drawings

[0011]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Mode for Carrying Out the Invention

[0012] Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings. The blood purification device according to this embodiment consists of a dialysis device for performing hemodialysis treatment. As shown in FIGS. 1 and 2, it has a blood circuit having an arterial side blood circuit 1 and a venous side blood circuit 2, a dialyzer 3 as a blood purifier, a blood pump 4, an air trap chamber 5, a pressure sensor 6, and a control unit 10, a liquid delivery amount detection unit 11, and a connection determination unit 12 disposed in the device main body 7.

[0013] The arterial side blood circuit 1 is composed of a flexible tube through which a predetermined liquid can flow, and an arterial side puncture needle a can be attached to its tip via a connector c. A physiological saline supply line L3 is connected to such an arterial side blood circuit 1 via a T-tube T1, and a storage container D called a raw food bag is connected to the tip of the physiological saline supply line L3. This physiological saline supply line L3 can be arbitrarily opened and closed by an electromagnetic valve or forceps (not shown) and is configured to supply the physiological saline in the storage container D into the blood circuit.

[0014] Also, a covering tube 1a is connected in the middle of the arterial side blood circuit 1 (between the T-tube T1 and the T-tube T2), and it is possible to attach such a covering tube 1a to the blood pump 4. The covering tube 1a can squeeze the internal liquid in the longitudinal direction while being compressed in the radial direction by the blood pump 4, and is composed of a flexible tube that is softer and has a larger diameter than the other flexible tubes constituting the arterial side blood circuit 1.

[0015] The blood pump 4 is for pumping the priming liquid and the patient's blood (liquid) in the blood circuit, and consists of a so-called squeezing pump equipped with a rotation-driven rotor and rollers. Along with the rotation drive of the rotor, the roller can squeeze the squeezed tube 1a in the rotation direction (longitudinal direction) of the rotor. Due to such squeezing action, the blood in the arterial blood circuit 1 will flow in the rotation direction of the rotor, so it is possible to perform extracorporeal circulation within the blood circuit 1.

[0016] Note that between the squeezed tube 1a and the dialyzer 3 in the arterial blood circuit 1, a T-tube T2 with an extended connecting tube L4 is connected. And between the dialyzer 3 and the pressure detection unit 6 in the venous blood circuit 2, a T-tube T3 with an extended connecting tube L5 is connected. At the tip ends of these connecting tubes L4 and L5, connection parts h1 and h2 to which the tip end of a syringe or the like can be connected to inject a desired liquid (such as a drug solution) are attached. Note that the flow paths of the connecting tubes L3 to L5 can be opened and closed by clamps (V1 to V3) (clamps on the device side or clamps on the blood circuit side).

[0017] The venous blood circuit 2 is composed of a flexible tube through which a predetermined liquid can flow. A venous puncture needle b can be attached to its tip via a connector d, and an air trap chamber 5 and a pressure detection unit 6 are connected. Also, at the tip end of the venous blood circuit 2 (between the connector d and the air trap chamber 5), a venous clamp F that can arbitrarily open and close the liquid flow path is attached.

[0018] The air trap chamber 5 is for defoaming the blood purified by the dialyzer 3 and is connected between the connector d and the pressure detection unit 6 in the venous blood circuit 2. The air trap chamber 5 according to this embodiment is configured to introduce blood (or priming liquid) from its upper part and discharge it from its lower part, and it is assumed that an air layer is not formed in the upper part of the internal space before blood purification treatment.

[0019] Note that connection tubes L6 and L7 extend from the upper part of the air trap chamber 5. Connection parts h3 and h4 are attached to the tip ends of these connection tubes L6 and L7, to which the tip end of a syringe or the like can be connected to introduce a desired liquid (such as a chemical solution) or to discharge the air accumulated by the defoaming action. The flow paths of the connection tubes L6 and L7 can be opened and closed by clamps (V4, V5) (a clamp on the device side or a clamp on the blood circuit side).

[0020] The pressure detection unit 6 is connected between the dialyzer 3 and the air trap chamber 5 and can detect the pressure in the blood circuit (specifically, the hydraulic pressure in the arterial side blood circuit 2). The pressure detection unit 6 according to the present embodiment includes a liquid phase part, a gas phase part, and a diaphragm that partitions between these liquid phase part and gas phase part. Then, while filling and flowing the blood (or priming liquid) circulating outside the body in the liquid phase part, displacing the diaphragm according to the hydraulic pressure of the blood, and measuring the pressure of the gas (such as air or a predetermined gas) in the gas phase part that changes according to the displacement of the diaphragm, the pressure (venous pressure) in the venous side blood circuit 2 can be detected.

[0021] As described above, in the blood circuit according to the present embodiment, an air layer is not formed in the upper part of the air trap chamber 5, and the liquid phase part of the pressure detection unit 6 is filled with liquid so that an air layer is not required. Thus, it constitutes an airless circuit in which an air layer is not set in the flow path of the blood circulating outside the body in the double-needle state and in the state where the chamber member 9 is not connected.

[0022] The dialyzer 3 is formed by housing a plurality of hollow fibers in which micropores (pores) are formed in a housing part. In the housing part, a blood introduction port 3a, a blood outlet port 3b, a dialysate introduction port 3c, and a dialysate outlet port 3d are formed. The proximal end of the arterial side blood circuit 1 is connected to the blood introduction port 3a, and the proximal end of the venous side blood circuit 2 is connected to the blood outlet port 3b. Further, the dialysate introduction port 3c and the dialysate outlet port 3d are respectively connected to a dialysate introduction line L1 and a dialysate discharge line L2 extending from the device main body 7.

[0023] Then, the blood of the patient introduced into the dialyzer 3 passes through the inside of the internal hollow fiber membrane (blood flow path) and is discharged from the blood discharge port 3b. On the other hand, the dialysate introduced from the dialysate introduction port 3c passes through the outside of the hollow fiber membrane (dialysate flow path) and is discharged from the dialysate discharge port 3d. Thus, waste products and the like in the blood passing through the blood flow path can be permeated to the dialysate side and purified, and the purified blood can be returned to the patient's body through the venous side blood circuit 2.

[0024] In this way, by connecting the dialyzer 3 between the arterial side blood circuit 1 and the venous side blood circuit 2 and driving the blood pump 4 with the arterial side puncture needle a and the venous side puncture needle b punctured into the patient, the blood of the patient can be extracorporeally circulated through the blood circuit (arterial side blood circuit 1 and venous side blood circuit 2) and the dialyzer 3, and the blood can be purified and returned to the patient.

[0025] Here, in the present embodiment, as shown in FIG. 1, a double-needle state in which the arterial side puncture needle a and the venous side puncture needle b are respectively attached to the tips of the arterial side blood circuit 1 and the venous side blood circuit 2, and as shown in FIG. 2, a single-needle state in which a single puncture needle e is attached to the tips of the arterial side blood circuit 1 and the venous side blood circuit 2 via a Y-shaped tube 8 are arbitrarily switchable. The Y-shaped tube 8 has two base ends connected to the connector a of the arterial side blood circuit 1 and the connector b of the venous side blood circuit 2, respectively, and a single puncture needle e is attached to the tip portion.

[0026] When performing blood purification treatment in the single-needle state, a single puncture needle e is punctured into the patient, and the blood pump 4 is driven with the venous clamp F in the closed state to collect the patient's blood from the single puncture needle e in the collection phase. Then, in the blood return phase, the venous clamp F is opened and the blood pump 4 is stopped to return the blood collected in the collection phase from the single puncture needle e to the patient. By repeating these two phases, the blood can be purified by the dialyzer 3 while circulating extracorporeally in the blood circuit.

[0027] The chamber member 9 is connected to the connection part h3 of the air trap chamber 5 in the single-needle state. In the blood collection phase of collecting blood from the patient, the blood in the venous blood circuit 2 flows in and is stored, and in the blood return phase of returning blood to the patient, the stored blood flows out from the chamber member 9 into the venous blood circuit 2 for blood return. Note that the chamber member 9 according to the present embodiment is connected to the connection part h3 of the connection tube L6 extending from the upper part of the air trap chamber 5, but it may also be connected to the connection part h4 of another connection tube L7.

[0028] More specifically, as shown in FIG. 3, the chamber member 9 includes a chamber part 9a capable of storing blood inside, a connection part 9b detachably connected to the connection part h3 of the air trap chamber 5, a connection tube 9c that allows the blood in the air trap chamber 5 to flow into the chamber part 9a by opening the clamp V6 (a clamp on the device side or a clamp on the blood circuit side) to communicate the connection part 9b and the chamber part 9a, a hydrophobic filter 9d that allows the passage of gas while blocking the passage of liquid, and a liquid level adjustment tube 9e that allows the hydrophobic filter 9d and the chamber part 9a to communicate by opening the clamp V7 (a clamp on the device side or a clamp on the blood circuit side) to adjust the liquid level in the chamber part 9a.

[0029] When performing blood purification treatment in the single-needle state, by connecting the connection part 9b to the connection part h3 of the air trap chamber 5, blood can flow into and be stored in the chamber part 9a during the blood collection phase. Note that the liquid level adjustment tube 9e is closed by a clamp V7 (a clamp on the device side or a clamp on the blood circuit side) during blood purification treatment to prevent pressure loss during the blood collection phase. The chamber member 9 according to the present embodiment is not connected when blood purification treatment is performed in the double-needle state, and can be connected to the connection part h3 by an operator when blood purification treatment starts in the single-needle state. That is, when performing blood purification treatment in the double-needle state, the chamber member 9 is unnecessary, and the chamber member 9 can be attached at an arbitrary timing before starting blood treatment in the single-needle state.

[0030] Furthermore, the apparatus main body 7 according to the present embodiment includes, in addition to pipes, pumps, etc. for flowing dialysis fluid and drainage fluid, a control unit 10, a liquid delivery amount detection unit 11, and a connection determination unit 12. The control unit 10 is composed of a microcomputer etc. connected to various actuators and sensors etc. provided in the present blood purification apparatus, and various controls for performing blood purification treatment in the double-needle state or blood purification treatment in the single-needle state are possible.

[0031] Also, when in the single-needle state, the control unit 10 according to the present embodiment closes the venous clamp F and drives the blood pump 4 to perform blood collection in the blood collection phase, and switches to the blood return phase when the pressure (venous pressure) detected by the pressure detection unit 6 reaches a preset upper limit pressure. At the same time, the venous clamp F is opened and the blood pump 4 is stopped to perform blood return in the blood return phase, and switches to the blood collection phase when the pressure (venous pressure) detected by the pressure detection unit 6 reaches a preset lower limit pressure. By repeating this, the blood collection phase and the blood return phase are repeated, and blood can be circulated extracorporeally in the blood circuit.

[0032] The liquid delivery volume detection unit 11 is composed of a microcomputer or the like electrically connected to the blood pump 4, and is configured to be able to detect the liquid delivery volume of the liquid due to the drive of the blood pump 4. More specifically, the liquid delivery volume detection unit 11 according to the present embodiment is capable of detecting the liquid delivery volume (stroke volume) of liquids such as blood and priming liquid based on the rotation amount of the rotor of the blood pump 4. Note that the liquid delivery volume may be detected based on parameters other than the rotation amount of the rotor of the blood pump 4.

[0033] The connection determination unit 12 is composed of a microcomputer or the like electrically connected to the liquid delivery volume detection unit 11 and the pressure detection unit 6, and determines the presence or absence of the connection of the chamber member 5 based on the liquid delivery volume detected by the liquid delivery volume detection unit 11 and the pressure (venous pressure) detected by the pressure detection unit 6. More specifically, the connection determination unit 12 according to the present embodiment determines whether or not the liquid delivery volume at the time when the upper limit pressure at which the switch is made from the blood collection phase to the blood return phase is reached exceeds a preset reference value in the single needle state, and if it does not exceed the reference value, it determines that the chamber member 9 is not attached (forgotten to be attached).

[0034] Furthermore, the connection determination unit 12 according to the present embodiment determines the presence or absence of the connection of the chamber member 9 in the single needle state as described above during blood purification treatment, and also determines the presence or absence of the connection of the chamber member 9 during the connection test by applying pressure before blood purification treatment. Such a connection test is executed to apply pressure (hydraulic pressure) to the piping and blood circuit in the apparatus main body 7 before blood purification treatment to determine whether or not it is normally connected. In the present embodiment, in addition to various connection tests, the connection determination unit 12 determines the presence or absence of the connection of the chamber member 9.

[0035] More specifically, before the start of blood purification treatment, as shown in FIG. 4, the connector c of the arterial blood circuit 1 and the connector d of the venous blood circuit 2 are connected to form a closed circuit, and the blood pump 4 is driven to circulate the physiological saline (priming solution) contained in the storage container D in the closed circuit, thereby performing priming. Before or after such priming, it is possible to determine whether or not the chamber member 9 is connected.

[0036] In this case, the venous clamp F is closed and the blood pump 4 is driven. When the liquid delivery amount of the physiological saline (priming solution) due to the driving of the blood pump 4 reaches a predetermined value, the connection determination unit 12 determines whether or not the pressure increase amount (venous pressure increase amount) detected by the pressure detection unit 6 is higher than a preset reference value. When it is higher than the reference value, it can be determined that the chamber member 9 is not connected. For example, when the reference value is 4.0 mL, the initial value can be set to 4.0 mL and can be changed within the range of 0 (not monitored) to 40.0 mL. In this case, since the stroke volume of the blood circuit when the chamber member 9 is not connected is 3.0 mL, when the chamber member 9 is connected, or the stroke volume of a normal blood circuit is about 4.5 to 6.0 mL, if the reference value is 4.0 mL, it is possible to detect a state where the chamber member 9 is not connected, and it is possible to suppress false alarms under other conditions. Regarding the set value in the range of 0 to 40.0 mL, since there is a risk that the notification will be troublesome, it is preferably set with 0 mL, which is not substantially monitored, as the lower limit value and 40.0 mL with a margin as the upper limit value. However, it is more preferable to arbitrarily change it according to the setting of the phase change pressure (upper limit pressure and lower limit pressure) and the venous pressure of the patient.

[0037] Although the presence or absence of connection of the chamber member 9 is determined based on the pressure increase (venous pressure increase amount) in the blood circuit when the liquid delivery amount due to the driving of the blood pump 4 reaches a predetermined value as described above, the blood pump 4 may be driven until the pressure increase (venous pressure increase) in the blood circuit reaches a predetermined value, and the presence or absence of connection of the chamber member 9 may be determined by detecting the liquid delivery amount at the time when the predetermined value is reached.

[0038] Also, in this embodiment, it is configured such that the presence or absence of connection of the chamber member 9 is determined in a state where the blood circuit is filled with a priming solution (physiological saline or dialysis solution). However, air (air) may be supplied into the blood circuit to determine the presence or absence of connection of the chamber member 9. Further, in the above embodiment, physiological saline is circulated in the blood circuit as the priming solution. However, a dialysis solution may be supplied from outside the blood circuit such as the apparatus main body 7 to be used as the priming solution. In this case, the presence or absence of connection of the chamber member 9 can be determined by detecting an increase in the liquid pressure when the dialysis solution (priming solution) is supplied, and it is not necessary to keep the venous clamp F in a closed state.

[0039] Next, the control when blood purification treatment is performed in a single-needle state by the blood purification apparatus according to this embodiment will be described based on the schematic diagram of FIG. 2 and the flowchart of FIG. 5. First, after a single puncture needle e is punctured into the patient, the blood pump 4 is driven while keeping the venous clamp F in a closed state (S1), and it is determined whether or not the pressure (venous pressure) detected by the pressure detection unit 6 has reached the upper limit pressure (S2).

[0040] In S2, if it is determined that the pressure (venous pressure) detected by the pressure detection unit 6 has reached the upper limit pressure, the liquid feed amount is detected based on the driving amount of the blood pump 4 (S3), and it is determined whether or not the detected liquid feed amount is more than a preset reference value (S4). Then, if it is determined that the liquid feed amount is not more than (less than) the preset reference value, in S5, a notification means provided in the apparatus main body 7 or the like notifies that the chamber member 9 is not connected, and the process proceeds to S6. At the same time, if it is determined that the liquid feed amount is less than (more than) the preset reference value, the notification in S5 is not performed, and the process proceeds to S6.

[0041] The blood collection phase ends as described above, and the blood return phase starts. In this blood return phase, while the venous clamp F is open, the blood pump 4 is stopped (S6), and it is determined whether or not the pressure (venous pressure) detected by the pressure detection unit 6 has reached the lower limit pressure (S7). Then, if it is determined in S7 that the pressure (venous pressure) detected by the pressure detection unit 6 has reached the lower limit pressure, the process returns to S1, and the blood collection phase is performed again. In this way, by alternately repeating the blood collection phase and the blood return phase, the patient's blood can be purified by the dialyzer 3 while being extracorporeally circulated in the blood circuit.

[0042] Next, the control when the connection test is performed in the single needle state by the blood purification device according to the present embodiment will be described based on the schematic diagram of FIG. 4 and the flowchart of FIG. 6. First, after connecting the connector c of the arterial side blood circuit 1 and the connector d of the venous side blood circuit 2 to form a closed circuit, the venous clamp F is closed and the pressure (venous pressure) detected by the pressure detection unit 6 is stored (S1).

[0043] Thereafter, in S2, the blood pump 4 is driven, and in S3, it is determined whether or not the liquid feed amount based on the driving of the blood pump 4 is greater than a predetermined value. If it is determined in S3 that the liquid feed amount based on the driving of the blood pump 4 is greater than the predetermined value, the blood pump 4 is stopped and the pressure (venous pressure) detected by the pressure detection unit 6 is stored (S4). Therefore, the pressure increase amount is obtained based on the pressure (venous pressure) stored in S1 and the pressure (venous pressure) stored in S4.

[0044] Then, it is determined whether or not the obtained pressure increase amount is greater than a preset reference value (S5). If it is determined that the pressure increase amount is greater than the reference value, in S6, a notification means provided in the device main body 7 or the like notifies that the chamber member 9 is not connected, and the process proceeds to S7. If it is determined that the pressure increase amount is not less than (greater than) the reference value, the notification in S6 is not performed, and the process proceeds to S7. Thereafter, in S7, the venous clamp F is opened and the connection test ends.

[0045] According to the present embodiment, based on the liquid delivery amount detected by the liquid delivery amount detection unit 11 and the pressure detected by the pressure detection unit 6 (venous pressure in the present embodiment), the presence or absence of connection of the chamber member 9 is determined. Therefore, when performing blood purification treatment in a single-needle state, it is possible to prevent forgetting to connect the chamber member 9. In particular, in the present embodiment, when the connection determination unit 12 determines that the chamber member 9 is not connected, notification is performed by the notification means, so that medical staff and the like can surely recognize forgetting to connect the chamber member 9.

[0046] Further, according to the present embodiment, a venous clamp F capable of opening and closing the flow path at the tip of the venous side blood circuit 2, and when in a single-needle state, the venous clamp F is closed and the blood pump 4 is driven to perform blood collection in the blood collection phase. When the pressure detected by the pressure detection unit 6 reaches a preset upper limit pressure, it is switched to the blood return phase, and the venous clamp F is opened and the blood pump 4 is stopped to perform blood return in the blood return phase. When the pressure detected by the pressure detection unit 6 reaches a preset lower limit pressure, it is switched to the blood collection phase. The control unit 10 is provided, and the connection determination unit 12 determines whether the liquid delivery amount at the time when the upper limit pressure at which the blood collection phase is switched to the blood return phase is reached exceeds a preset reference value, thereby determining the presence or absence of connection of the chamber member 9. Therefore, it is possible to determine the presence or absence of connection of the chamber member 9 during the process of blood purification treatment in a single-needle state.

[0047] Furthermore, it includes an air trap chamber 5 connected to the venous side blood circuit 2, and since the chamber member 9 is detachable from the air trap chamber 5, the chamber member 9 can be optionally connected only when performing blood purification treatment in a single needle state. In particular, the air trap chamber 5 has a connection tube L6 extending from its upper part, and the chamber member 9 can be connected to the connection tube L6 at an arbitrary timing. Therefore, for example, for drug injection, etc., the chamber member 9 can be connected by diverting the connection tube L6 for other uses required in blood purification treatment. Note that the chamber member 9 may be connected to the connection tube L7 at an arbitrary timing.

[0048] Moreover, according to the present embodiment, since the determination of the presence or absence of the connection of the chamber member 9 by the connection determination unit 12 is performed when the blood purification treatment is started in the single needle state, it is possible to surely prevent the blood purification treatment in the single needle state from being performed in a state where the chamber member 9 is forgotten to be connected. Also, if the determination of the presence or absence of the connection of the chamber member 9 by the connection determination unit 12 is performed during the connection test by applying pressure before the blood purification treatment, it is possible to prevent the chamber member 9 from being forgotten to be connected when the blood purification treatment in the single needle state is performed after the connection test.

[0049] Furthermore, the blood circuit applied to the present embodiment consists of an airless circuit in which an air layer is not set in the blood flow path for extracorporeal circulation in the double needle state. Therefore, when performing blood purification treatment in the double needle state, it is possible to avoid the air and blood in the air layer in the blood circuit from coming into contact, and it is also possible to eliminate the need to replace the blood circuit even when switching from the double needle state to the single needle state.

[0050] That is, when performing blood purification treatment in a single-needle state using an airless circuit, since there is almost no air layer in the blood flow path, in a conventional blood circuit, it is impossible to store a sufficient amount of blood during the blood sampling phase, and there is a risk that the dialysis efficiency will decrease. Therefore, conventionally, in addition to the airless circuit, it was necessary to prepare a normal blood circuit for performing blood purification treatment in a single-needle state.

[0051] Also, conventionally, when starting blood purification treatment in a double-needle state using an airless circuit and then switching to a single-needle state to continue the blood purification treatment, it is necessary to switch from the airless circuit to a normal blood circuit. In this case, after returning the blood remaining in the airless circuit to the patient, it is necessary to switch to a normal blood circuit. Therefore, the replacement operation is troublesome, and after blood purification treatment, both the normal blood circuit and the airless circuit need to be discarded, resulting in the problem that the amount of blood circuits to be discarded increases.

[0052] On the other hand, according to the present embodiment, when blood purification treatment is performed in a single-needle state, the chamber member 9 can be connected. Therefore, it is possible to perform blood purification treatment well in a single-needle state while maintaining the effect of the airless circuit when performing blood purification treatment in a double-needle state.

[0053] As described above, the present embodiment has been described, but the present invention is not limited to these. For example, in addition to connecting the chamber member 9 to the upper part of the air trap chamber 5, it may be connected to a downstream side from the arrangement position of the blood pump 4 in the blood circuit (for example, connected to an arbitrary position such as a connection tube L4 located between the blood pump 4 and the dialyzer 3, a connection tube L5 located between the dialyzer 3 and the pressure detection unit 6).

[0054] In addition, the connection determination unit 12 according to the present embodiment determines whether or not the connection of the chamber member 9 is present by determining whether or not the liquid feed amount at the time when the upper limit pressure at which the phase switches from the blood collection phase to the blood return phase is reached exceeds a preset reference value. However, it may be determined whether or not the connection of the chamber member 9 is present by determining whether or not the liquid feed amount at the time when another predetermined pressure (hydraulic pressure) different from the upper limit pressure is reached exceeds the reference value. Alternatively, it may be determined whether or not the connection of the chamber member 9 is present by determining whether or not the pressure (hydraulic pressure) detected by the pressure detection unit 6 at the time when the liquid feed amount reaches a predetermined value exceeds the predetermined value.

[0055] Furthermore, in the present embodiment, an airless circuit is applied as the blood circuit, but a normal blood circuit (a blood circuit in which an air layer is provided) that is not an airless circuit may also be used. Additionally, when the connection determination unit 12 determines that the chamber member 9 is not connected, in addition to notifying, it may automatically stop the blood purification treatment or the like. Note that the form of notification when the chamber member 9 is not connected may be any form such as being displayed on a monitor, output by a speaker, or causing an indicator light to light up or blink.

Industrial Applicability

[0056] If it has the same gist as the present invention, it can also be applied to those with different external shapes or those with other functions added.

Explanation of Reference Numerals

[0057] 1 Arterial side blood circuit 1a Covering tube 2 Venous side blood circuit 3 Dialyzer (blood purifier) 3a Blood introduction port 3b Blood outlet port 3c Dialysate introduction port 3d Dialysate outlet port 4 Blood pump 5 Air trap chamber 6 Pressure detection unit 7 Apparatus main body 8 Y-shaped tube 9 Chamber member 9a Chamber part 9b Connection part 9c Connection tube 9d Hydrophobic filter 9e Liquid level adjustment tube 10 Control unit 11 Liquid delivery amount detection unit 12 Connection determination unit a Arterial side puncture needle b Venous side puncture needle c, d Connector e Single puncture needle D Storage container T1~T3 T-shaped tube F Venous clamp L3 Physiological saline supply line L4~L7 Connection tubes

Claims

1. A blood purification device that extracorporeally circulates a patient's blood through a blood circuit and a blood purifier having an arterial side blood circuit and a venous side blood circuit, purifies the blood, and has a double-needle state in which an arterial side puncture needle and a venous side puncture needle are respectively attached to the tips of the arterial side blood circuit and the venous side blood circuit, and a single-needle state in which a single puncture needle is attached to the tips of the arterial side blood circuit and the venous side blood circuit via a Y-tube, and the two states can be arbitrarily switched, a blood pump for pumping a liquid in the blood circuit, a liquid feed amount detection unit for detecting the liquid feed amount by driving the blood pump, a pressure detection unit for detecting the pressure in the blood circuit, When in the single-needle state, it is connected downstream of the arrangement position of the blood pump in the blood circuit, and in the blood sampling phase of collecting blood from the patient, the blood in the blood circuit flows in and is stored, and in the blood return phase of returning blood to the patient, the stored blood flows out of the blood circuit and is returned. A chamber member for returning blood, a connection determination unit for determining the presence or absence of connection of the chamber member based on the liquid feed amount detected by the liquid feed amount detection unit and the pressure detected by the pressure detection unit, A blood purification device comprising the above.

2. a venous clamp capable of opening and closing the flow path at the tip of the venous side blood circuit, When in the single-needle state, the venous clamp is closed and the blood pump is driven to perform blood sampling in the blood sampling phase, and when the pressure detected by the pressure detection unit reaches a preset upper limit pressure, it is switched to the blood return phase, and the venous clamp is opened and the blood pump is stopped to perform blood return in the blood return phase. A control unit that switches to the blood sampling phase when the pressure detected by the pressure detection unit reaches a preset lower limit pressure, comprising, and the connection determination unit determines whether the liquid delivery amount at the time when the upper limit pressure at which the phase switches from the blood collection phase to the blood return phase is reached exceeds a preset reference value, thereby determining whether the chamber member is connected. The blood purification device according to claim 1.

3. comprising an air trap chamber connected to the venous side blood circuit, and the chamber member is detachable from and attachable to the air trap chamber. The blood purification device according to claim 1 or claim 2.

4. The air trap chamber has a connection tube extending from its upper part, and the chamber member can be connected to the connection tube at an arbitrary timing. The blood purification device according to claim 3.

5. The determination of whether the chamber member is connected by the connection determination unit is performed when the blood purification treatment in which the control of the single-needle state is performed is started. The blood purification device according to any one of claims 1 to 4.

6. The determination of whether the chamber member is connected by the connection determination unit is performed during a connection test by applying pressure before blood purification treatment. The blood purification device according to any one of claims 1 to 5.

7. The blood circuit comprises an airless circuit in which no air layer is set in the blood flow path for extracorporeal circulation in the double-needle state. The blood purification device according to any one of claims 1 to 6.

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