JP6671159B2 - Blood purification device - Google Patents

Description

  The present invention relates to a blood purification apparatus for purifying blood of a patient while circulating the blood extracorporeally.

  A dialysis device as a blood purification device includes a blood circuit having an arterial puncture needle at the tip thereof, a venous blood circuit having a venous needle at the tip thereof, and an arterial blood circuit having a venous needle at the tip. A dialyzer interposed between the side blood circuit and the venous side blood circuit to purify blood flowing through the blood circuit, a blood pump disposed in the arterial side blood circuit, and a dialyser for supplying the dialyzer to the dialyzer And a dialysis device main body capable of discharging drainage from the dialyzer.

  By the way, recently, there has been proposed a technique for performing emergency fluid replacement and blood return using a dialysate to be supplied to a dialyzer. For example, Patent Literature 1 discloses a dialysate introduction line capable of introducing a dialysate into a dialyzer, a dialysate discharge line capable of leading out drainage from a dialyzer, and a base end connected to a dialysate introduction line and a distal end. Has a replenisher introduction line (replenisher introduction line) connected to the arterial blood circuit (between the blood pump and the tip of the arterial blood circuit). A blood purification device that introduces a dialysate and injects replacement fluid into a patient's body is disclosed.

JP 2004-313522 A

  However, in the above-described conventional blood purification apparatus, the replenisher is introduced due to some factor (for example, when restoration is not sufficiently performed when the flow path is clamped or when the flow path is bent). When the flow path is closed, there is a risk that emergency rehydration cannot be performed. Further, the replenisher is not limited to the emergency replenisher, but is also introduced into the blood circuit when returning blood in the blood circuit to the patient.In this case as well, the flow path for introducing the replenisher is blocked. If so, there is a possibility that blood cannot be returned.

  In order to solve this problem, if a separate sensor or the like for detecting the blockage of the flow path by detecting the negative pressure is separately provided, the cost increases correspondingly, and the sensors are provided. Therefore, a branch or a step is required in the flow path, which may hinder blood extracorporeal circulation during treatment. It is to be noted that such a defect may occur in another process different from the emergency fluid replacement and blood return, and also in other parts of the blood circuit (for example, the venous blood circuit side).

  The present invention has been made in view of such circumstances, and it is an object of the present invention to provide a blood purification apparatus that can detect blockage of a flow path without newly providing additional sensors.

The invention according to claim 1 has a blood circuit having an arterial blood circuit and a venous blood circuit, and capable of extracorporeally circulating a patient's blood from the tip of the arterial blood circuit to the tip of the venous blood circuit. Blood purifying means interposed between the arterial blood circuit and the venous blood circuit of the circuit to purify blood flowing through the blood circuit, clamping means capable of clamping a part of the blood circuit, and clamping by the clamping means Oscillating means capable of oscillating ultrasonic waves in the flow path, and receiving means capable of receiving ultrasonic waves oscillated from the oscillating means and transmitted or reflected through the flow path, and receiving the ultrasonic waves received by the receiving means. Bubble detection means capable of detecting bubbles in the liquid flowing through the flow path based on the flow path, and on the condition that bubbles are detected by the bubble detection means, clamps and closes the flow path held by the holding means. Gain In the blood purification apparatus provided with a pumping means, an ultrasonic wave is oscillated from the oscillating means in a state where there is no flow of a liquid in the flow channel held by the holding means, and the ultrasonic wave is received by the receiving means. A control unit capable of performing a pressure detection step; and a negative unit capable of detecting a negative pressure of the flow path or the communication path that is held by the holding means based on the ultrasonic waves received by the receiving means in the negative pressure detection step. as well as and a pressure detecting means, by the state of closing the flow path in said clamping means, together with causing the negative pressure detecting step and in the flow path and the absence liquid flow, the It is characterized in that the bubbles detected by the bubble detecting means are prevented from reaching the patient's body .

According to a second aspect of the invention, the blood purification apparatus according to claim 1, wherein the negative pressure detecting step, fluid replacement process during which the replenisher was introduced replenisher to the blood circuit may be replacement fluid is injected into the patient Or in a blood return step of returning blood from the blood circuit to the patient.

According to a third aspect of the present invention, in the blood purification apparatus according to the first or second aspect , the air bubble detecting means is provided at a distal end portion of the arterial blood circuit and is provided in the arterial blood circuit. A replenisher introducing line for introducing a replenisher to be replenished to the blood circuit into the blood circuit is connected between the provided blood pump and the air bubble detector. By driving the blood pump to rotate forward while keeping the pump closed, the negative pressure detection step can be performed while introducing a replenisher from the replenisher introduction line.

According to a fourth aspect of the present invention, in the blood purification apparatus according to the third aspect , the replenisher introduction line is connected at its base end to a dialysate introduction line for introducing a dialysate into the blood purification means. A dialysate as a replenisher can be introduced from the introduction line into the blood circuit.

According to a fifth aspect of the present invention, in the blood purification apparatus according to the third aspect , the replenishing solution introduction line has a base end connected to a containing bag containing a predetermined volume of a physiological saline solution, and from the containing bag as a replenishing solution. Wherein the physiological saline can be introduced into the blood circuit.

According to the first aspect of the present invention, a negative pressure detecting step of oscillating ultrasonic waves from the oscillating means and receiving the ultrasonic waves by the receiving means in a state where there is no flow of the liquid in the flow path sandwiched by the sandwiching means is performed. And a negative pressure detecting means capable of detecting the negative pressure of the flow path held by the holding means or the communicating flow path based on the ultrasonic waves received by the receiving means in the negative pressure detecting step. In addition, the blockage of the flow path can be detected without separately providing additional sensors.
Further, provided that the air bubble is detected by the air bubble detection means, and a clamp means capable of clamping and closing the flow path held by the holding means and closing the flow path by the clamp means is provided. By doing so, it is possible to prevent the flow of liquid in the flow path, so that the function of preventing bubbles from reaching the patient's body by the bubble detection means and the clamp means can be used to perform the negative pressure detection step. it can.

According to the invention of claim 2, negative pressure detecting step is returned during fluid replacement process capable of replacement fluid by introducing replenisher to the blood circuit by injecting the replenisher to the patient or blood circuit of the blood back to the patient Since it is performed during the blood process, replacement fluid or blood return can be reliably performed.

According to the third aspect of the present invention, the bubble detecting means is provided at the distal end of the arterial blood circuit, and between the blood pump provided in the arterial blood circuit and the bubble detecting means. A replenisher introducing line is connected to a replenisher introducing line for introducing a replenisher replenished to the blood circuit into the blood circuit, and the blood pump is driven to rotate forward while the flow path is closed by the clamp means. Since the negative pressure detection step can be performed while introducing the replenisher from the apparatus, it is possible to detect blockage of the replenisher introduction line and the flow path at the distal end of the arterial blood circuit.

According to the invention of claim 4 , the replenisher introduction line is connected at its base end to the dialysate introduction line for introducing the dialysate into the blood purification means, and the dialysate as a replenisher is supplied from the dialysate introduction line to the blood. Since it can be introduced into a circuit, it can be applied to a blood purification apparatus that uses a dialysate as a replenisher.

According to the invention of claim 5 , the replenisher introduction line is connected at its base end to a storage bag containing a predetermined volume of physiological saline, and introduces a physiological saline as a replenisher from the storage bag into the blood circuit. Therefore, the present invention can be applied to a blood purification apparatus using physiological saline as a replenisher.

Schematic diagram showing a blood purification device according to an embodiment of the present invention. Side view showing air bubble detection means in the blood purification apparatus Front view showing the bubble detection means IV-IV line sectional view in FIG. FIG. 2 is a cross-sectional view showing a blood discriminating means provided in the holding means in the air bubble detecting means (a cross-sectional view taken along line VV in FIG. 2). FIG. 2 is a cross-sectional view (a cross-sectional view taken along the line VI-VI in FIG. 2) illustrating the bubble detection unit (a state in which the holding unit is not being held) Sectional drawing showing the same air bubble detection means (in the state where the holding by the holding means was performed). Schematic diagram showing a flow path (a state in which a negative pressure is generated) held by the holding means of the bubble detection means. FIG. 4 is a schematic view showing a flow path (a state in which no negative pressure is generated) pinched by the pinching means of the bubble detecting means. Graph showing the detection value (when bubbles are detected) by the bubble detection means Graph showing the detection value (when negative pressure is detected) by the bubble detection means Schematic diagram showing a blood purification device according to another embodiment of the present invention.

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The blood purification apparatus according to the present embodiment is for performing blood purification treatment (for example, hemodialysis treatment) by circulating the blood of a patient extracorporeally, and as shown in FIG. An arterial blood circuit 1a, which is connectable and has a liquid flow path therein, and a venous blood circuit 1b, to which a venous puncture needle (not shown) can be connected, is provided at the tip 1ba. A blood circuit 1 capable of extracorporeal circulation, a dialyzer 2 (blood purification means) interposed between the arterial blood circuit 1a and the venous blood circuit 1b to purify blood flowing through the blood circuit 1, and an arterial blood circuit 1a , An arterial air trap chamber 4 connected to the arterial blood circuit 1a, a venous air trap chamber 5 connected to the venous blood circuit 1b, and a dialyzer. 2 A dialysate inlet line L1 for introducing the dialysate, and the dialysate discharge line L2 that discharges the drainage from the dialyzer 2, the control unit 13 is configured to have a negative pressure detecting means 14. Each of the arterial blood circuit 1a and the venous blood circuit 1b has a liquid flow path therein.

  The arterial blood circuit 1a has a distal end 1aa connected to a connector (not shown). An arterial puncture needle can be connected through the connector. A side air trap chamber 4 is provided. On the other hand, in the venous blood circuit 1b, a connector (not shown) is connected to the distal end 1ba, and a venous puncture needle can be connected via the connector. It is connected.

  Then, the blood pump 3 is driven while the artery-side puncture needle connected to the tip 1aa of the arterial-side blood circuit 1a and the venous-side puncture needle connected to the tip 1ba of the venous-side blood circuit 1b are punctured into the patient (forward). When rotated, the blood of the patient reaches the dialyzer 2 through the arterial blood circuit 1a while defoaming (removing bubbles) in the arterial air trap chamber 4, and the blood is purified by the dialyzer 2. After that, the air returns to the patient through the venous blood circuit 1b while defoaming (removing bubbles) in the venous air trap chamber 5. This allows the dialyzer 2 to purify the patient's blood while circulating it extracorporeally from the tip 1aa of the arterial blood circuit 1a of the blood circuit 1 to the tip 1ba of the venous blood circuit 1b.

  An ironing tube C is connected in the middle of the arterial blood circuit 1a, and the ironing tube C can be attached to the blood pump 3. The ironing tube C is compressed in the radial direction by rollers of the blood pump 3 (ironing pump) and is squeezed in the longitudinal direction while closing off the flow path, so that the liquid inside can flow in the rotation direction of the rotor. Yes, it is made of a flexible tube that is softer and larger in diameter than the other flexible tubes that make up the arterial blood circuit 1.

  The dialyzer 2 has a blood inlet 2a (blood inlet port), a blood outlet 2b (blood outlet port), a dialysate inlet 2c (dialysate flow channel inlet: dialysate inlet port), and a dialysate in its housing. An outlet port 2d (dialysate outlet: dialysate outlet port) is formed, and the arterial blood circuit 1a is connected to the blood inlet port 2a, and the venous blood circuit 1b is connected to the blood outlet port 2b. Have been. Further, the dialysate inlet 2c and the dialysate outlet 2d are connected to a dialysate inlet line L1 and a dialysate outlet line L2, respectively.

  A plurality of hollow fiber membranes (not shown) are housed in the dialyzer 2, and the hollow fibers constitute a blood purification membrane for purifying blood. In the dialyzer 2, a blood flow path (a flow path between the blood inlet 2a and the blood outlet 2b) through which a patient's blood flows through a blood purification membrane and a dialysate flow path (a dialysate flow) through which a dialysate flows. A flow path between the inlet 2c and the dialysate outlet 2d) is formed. Usually, blood flows inside the hollow fiber and dialysate flows outside the hollow fiber. The hollow fiber membrane constituting the blood purification membrane is formed with a large number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface thereof, thereby forming a hollow fiber membrane. It is configured so that impurities and the like in blood can permeate into the dialysate.

  On the other hand, while the dialysate adjusted to a predetermined concentration is sent to the dialyzer 2 to the dialysate introduction line L1 and the dialysate discharge line L2, waste products and the like (drainage) are discharged together with the dialysate from the dialyzer 2. A double pump 6 is connected. That is, the dual pump 6 is provided so as to straddle the dialysate introduction line L1 and the dialysate discharge line L2. By driving the dual pump 6, the dialysate is dialed into the dialysate introduction line L1 with respect to the dialyzer 2. Is introduced and the drainage fluid can be discharged through the dialysate discharge line L2.

  The dialysate introduction line L1 is connected to solenoid valves V1 and V3 and filtration filters F1 and F2, so that the dialysate to be introduced into the dialyzer 2 can be filtered by the filtration filters F1 and F2. , V3, the flow path can be cut off or opened at an arbitrary timing. The dialysate introduction line L1 is connected to the dialysate discharge line L2 at bypass lines L4 and L5, and the bypass lines L4 and L5 are connected to solenoid valves V4 and V5, respectively.

  Further, bypass lines L3 and L6 bypassing the dual pump 6 are connected to the dialysate discharge line L2. An electromagnetic valve V6 is connected to the bypass line L6, and a dewatering pump 7 is connected to the bypass line L3. Is connected. By driving the water removal pump 7 in the process of extracorporeal circulation of the patient's blood in the blood circuit 1, water can be removed from the blood flowing through the dialyzer 2 to remove water.

  Further, a pressure pump 8 for adjusting the fluid pressure of the dialysate discharge line L2 of the dual pump 6 is connected to the upstream side (left side in FIG. 1) of the dual pump 6 in the dialysate discharge line L2. An open line L <b> 7 extends from between the pressurizing pump 8 and the compound pump 6 via a degassing chamber 9. Solenoid valves V2 and V7 are connected to the dialysate discharge line L2 and the open line L7 branched therefrom, respectively, so that the dialysate flow path can be cut off or opened at an arbitrary timing.

  The replenishment line L8 (replenisher introduction line) has a sampling port P (sample port) whose base end is formed at a predetermined portion of the dialysate introduction line L1 (in this embodiment, between the solenoid valve V1 and the filtration filter F2). ), And the distal end is connected to the arterial blood circuit 1a (the distal end 1aa side from the disposition position of the blood pump 3), and the dialysate (replenisher) of the dialysate introduction line L1 is supplied to the arterial blood circuit 1a. And a flow path that can be supplied to the The replenishing line L8 is connected to a clamp means V10, and by opening the clamp means V10, the dialysate in the dialysate introduction line L1 is supplied to the blood circuit 1 (arterial blood circuit 1a). In addition to being able to supply, the channel can be closed by closing the clamp means V10.

  However, if the patient's blood pressure drops rapidly during dialysis treatment, emergency fluid replacement may be performed. At the time of such emergency fluid replacement, the electromagnetic valves V1 and V2 and the clamp means 12 at the distal end of the arterial blood circuit 1a are closed (the clamp means 12 at the distal end of the venous blood circuit 1b is open) and the clamp means V10 Is opened to open the flow path of the replacement fluid introduction line L8. When the dual pump 6 and the blood pump 3 are driven (the blood pump 3 is driven to rotate forward), the dialysate in the dialysate introduction line L1 flows through the arterial blood circuit 1a and the venous blood circuit 1b, and the venous puncture is performed. It will be replenished into the patient's body via the needle and emergency rehydration will be performed.

  Further, the distal end of the arterial blood circuit 1a (between the distal end 1aa of the arterial blood circuit 1a and the connection of the replacement fluid introduction line L8) and the distal end 1ba of the venous blood circuit 1b (the distal end of the venous blood circuit 1b). Between 1ba and the venous air trap chamber 5, a bubble detecting means 10, a blood discriminating means 11, and a clamping means 12 are provided, respectively. These bubble detecting means 10, blood discriminating means 11 and clamping means 12 have a common holding means H.

  The holding means H is disposed at each of the distal end of the arterial blood circuit 1a and the distal end of the venous blood circuit 1b. As shown in FIGS. 2 to 7, the main body Ha, the lid Hb, And a fitting groove Haa into which the flexible tube constituting the arterial blood circuit 1a or the venous blood circuit 1b is fitted. The lid Hb is swingably attached to the main body Ha via a swing axis L, and can be opened and closed by swinging about the swing axis L.

  Then, by closing the lid Hb in a state where the flexible tube is fitted in the fitting groove Haa, as shown in FIGS. The tube (part of the blood circuit) can be clamped from above and below. A switch f is formed at a predetermined position of the fitting groove Haa, and the switch f is turned on when the flexible tube is normally clamped in the fitting groove Haa. This makes it possible to detect whether or not the flexible tube is normally clamped in the fitting groove Haa.

  Further, the lid portion Hb is formed with a lock portion Hba which can be locked with the main body portion Ha in a closed state, and the state of sandwiching the flexible tube is securely held by the lock by the lock portion Hba. You. The air bubble detecting means 10, the blood discriminating means 11, and the clamping means 12 are provided along the extending direction of the fitting groove Haa in the main body Ha, and a part of the blood circuit clamped by the clamping means H. In contrast, the apparatus is configured to be able to detect bubbles by the bubble detecting means 10, determine blood by the blood determining means 11, and open / close the flow path by the clamp means 12.

  The clamping means 12 is capable of closing and opening a flow path (that is, a flow path at the distal end of the arterial blood circuit 1a or the distal end of the venous blood circuit 1b) in each of the disposed portions by opening and closing operations. On the condition that bubbles are detected by the bubble detecting means 10, the flow path clamped by the clamping means H can be clamped and closed. 2 and 4, reference symbol R indicates a push rod provided in the clamp means 12, and by moving the push rod R forward and backward with respect to the fitting groove Haa, the push rod R is formed in the fitting groove Haa. The sandwiched flow path can be closed and opened.

  The blood discriminating means 11 is for discriminating whether or not blood is flowing in the flow path at the distal end of the arterial blood circuit 1a or the distal end of the venous blood circuit 1b, as shown in FIG. For example, it includes a light emitting element A1 composed of an LED and a light receiving element A2. The light emitting element A1 and the light receiving element A2 are disposed on the left and right sides of the fitting groove Haa, respectively, and constitute the arterial blood circuit 1 and the venous blood circuit 2 fitted by the fitting groove Haa. Light can be emitted from the light emitting element A1 toward the flexible tube, and the light can be received by the light receiving element A2.

  The light receiving element A2 is configured so that the voltage changes according to the amount of received light, and is configured to be able to determine the presence or absence of blood flowing through the arterial blood circuit 1a and the venous blood circuit 1b based on the detected voltage. ing. That is, the transmittance of light emitted from the light emitting element A1 is different between blood and the replenisher (the dialysate in the present embodiment) (the replenisher such as a dialysate or a physiological saline solution transmits light more than the blood). (The rate is high), the voltage detected by the light receiving element A2 exceeds the predetermined threshold value, so that it is detected that the flowing liquid has been replaced with blood from the replenisher.

  The bubble detecting means 10 is composed of a sensor capable of detecting bubbles (air) flowing through the arterial blood circuit 1a and the venous blood circuit 1b at a portion (predetermined position) held by the holding means H, as shown in FIG. In addition, an ultrasonic vibration element A3 (oscillating means) composed of, for example, a piezoelectric element, and an ultrasonic receiving element A4 (receiving means) composed of a piezoelectric element are provided. The ultrasonic vibration element A3 (oscillating means) is disposed below the fitting groove Haa in the main body portion Ha, and is capable of oscillating ultrasonic waves in the flow path sandwiched by the sandwiching means H. The ultrasonic receiving element A4 (receiving means) is provided at a predetermined portion of the lid Hb (a portion facing the ultrasonic vibration element A3 when the lid Hb is closed), and the ultrasonic receiving element A4 is provided. Ultrasonic waves oscillated from A4 and transmitted through the flow path can be received.

  Then, ultrasonic waves can be emitted from the ultrasonic vibration element A3 toward the flexible tubes constituting the arterial blood circuit 1 and the venous blood circuit 2 fitted by the fitting grooves Haa, and the vibrations are superposed. The sound wave receiving element A4 can receive the sound. The ultrasonic receiving element A4 is configured so that the voltage changes in accordance with the received vibration, and when the detected voltage exceeds a predetermined threshold, the voltage is changed to the arterial blood circuit 1a and the venous blood circuit 1b. It is configured to detect that the air bubble has flowed.

  That is, the value detected by the bubble detecting means 10 (the voltage corresponding to the vibration received by the ultrasonic receiving element A4) is configured to change within a certain range as shown in FIG. Since the bubble has a higher attenuation rate of the ultrasonic wave than the blood or the replenisher, the voltage detected by the ultrasonic receiving element A4 decreases as shown in FIG. Then, when the voltage detected by the ultrasonic receiving element A4 falls below a predetermined threshold value, it is detected that the bubble has flowed.

  The bubbles in the liquid flowing through the flow path can be detected by the bubble detecting means 7 having the above configuration based on the ultrasonic waves received by the ultrasonic receiving element A4 (receiving means). Thus, according to the present embodiment, the blood purification treatment is performed by the dialyzer 3 while circulating the patient's blood extracorporeally in the arterial blood circuit 1a and the venous blood circuit 1b. When it is detected that the liquid flowing in the position has been replaced with blood from the replenisher, or when the flow of air bubbles is detected by the air bubble detection means 10, the clamp means 12 is closed to terminate or interrupt the dialysis treatment or blood return. Can be.

  Further, in the dialysis apparatus main body according to the present embodiment, a control means 13 and a negative pressure detection means 14 which are composed of, for example, a microcomputer are provided. The control means 13 oscillates ultrasonic waves from the ultrasonic vibration element A3 (oscillation means) of the bubble detection means 10 in a state where no liquid flows in the flow path sandwiched by the holding means H, and receives the ultrasonic waves. In the present embodiment, a negative pressure detection step of receiving by the element A4 (receiving means) can be performed. In the present embodiment, a replacement fluid (replenishment solution) is introduced into the blood circuit 1 and the replacement fluid can be injected into a patient. The negative pressure detecting step is sometimes performed.

  The negative pressure detecting means 14 can detect the negative pressure of the flow path held by the holding means H or the flow path connected thereto based on the ultrasonic wave received by the ultrasonic receiving element A4 (receiving means) in the negative pressure detecting step. Things. That is, during the negative pressure detection step, the replacement fluid introduction line L8 or the distal end of the arterial blood circuit 1a (between the distal end 1aa of the arterial blood circuit 1a and the position of the blood pump 3; If the position between the position of the clamp means 12 and the position of the blood pump 3 in the circuit 1a) is closed, the inside of the flow path held by the holding means H becomes negative pressure, and the state shown in FIG. The diameter of the flow path is reduced to the state shown in FIG.

  With the diameter of the flow path reduced in this way, ultrasonic waves are oscillated from the ultrasonic vibration element A3 (oscillating means) of the bubble detecting means 10 and the ultrasonic waves are received by the ultrasonic receiving element A4 (receiving means). Then, as shown in FIG. 8, the contact area between the ultrasonic vibrating element A3 (oscillating means) and the ultrasonic receiving element A4 (receiving means) and the channel sandwiched by the sandwiching means H is reduced. As indicated by β in FIG. 11, the voltage detected by the ultrasonic receiving element A4 decreases. By detecting this voltage drop, it is possible to detect the negative pressure of the flow path held by the holding means H or the flow path connected thereto.

  More specifically, at the time of emergency fluid replacement, as described above, the solenoid valves V1 and V2 and the clamp means 12 at the distal end of the arterial blood circuit 1a are closed (the clamp means 12 at the distal end of the venous blood circuit 1b are closed). While the clamp V10 is in the open state, the flow path of the replacement fluid introduction line L8 is opened, and the dual pump 6 and the blood pump 3 are driven (the blood pump 3 is driven to rotate forward), whereby the dialysate introduction line L1 is opened. Dialysis fluid is replenished into the patient's body to make an emergency fluid replacement. During such emergency rehydration, the flow path held by the holding means H at the distal end of the arterial blood circuit 1a is in a state in which no liquid flows.

  Thus, during the emergency rehydration, the negative pressure detecting step is performed under the control of the control means 13. That is, during the emergency fluid replacement, under the control of the control means 13, ultrasonic waves are oscillated from the ultrasonic vibration element A3 (oscillation means) of the bubble detection means 10, and the ultrasonic waves are transmitted to the ultrasonic reception element A4 (reception means). At the same time, the negative pressure is detected by the negative pressure detecting means 14 based on the ultrasonic wave received by the ultrasonic wave receiving element A4 (receiving means) in the negative pressure detecting step. By detecting the pressure, it is possible to detect occlusion of the replacement fluid introduction line L8 or the distal end of the arterial blood circuit 1a (between the distal end 1aa of the arterial blood circuit 1a and the position of the blood pump 3). is there.

  As described above, when the negative pressure is detected by the negative pressure detecting means 14, when the replacement fluid introduction line L8 or the distal end of the arterial blood circuit 1a (the distal end 1aa in the arterial blood circuit 1a and the position of the blood pump 3 are disposed). (For example, display on a monitor, output of an alarm sound from a speaker, and the like). This allows a medical worker to quickly grasp the blockage of the flow path.

  According to the above-described embodiment, ultrasonic waves are oscillated from the ultrasonic vibrating element A3 (oscillating means) in a state in which no liquid flows in the flow path held by the holding means H, and the ultrasonic waves are received by the ultrasonic receiving element A4 ( The receiving means), the control means 13 capable of performing a negative pressure detecting step, and the flow path held by the holding means H based on the ultrasonic waves received by the ultrasonic receiving element A4 in the negative pressure detecting step, or the communication therewith. Since the apparatus has the negative pressure detecting means 14 capable of detecting the negative pressure of the flow path, it is possible to detect the blockage of the flow path without separately providing additional sensors.

  That is, since the negative pressure detecting step (oscillation and reception of ultrasonic waves by the bubble detecting means 10) is performed in a state where no liquid flows in the flow path held by the holding means H, a bubble detection signal (see FIG. 10) Therefore, it is possible to reliably avoid confusion with the above, and it is possible to more accurately detect the negative pressure in the flow path.

  In addition, the negative pressure detection step according to the present embodiment is performed during the rehydration step in which a rehydration fluid is introduced into the blood circuit 1 and the rehydration fluid can be injected into a patient, so that the rehydration fluid can be reliably performed. The negative pressure detection step is not limited to the fluid replacement step, and may be performed in another step (for example, in a blood return step of returning blood in the blood circuit 1 to a patient). In this manner, by performing the negative pressure detection step at the time of fluid replacement or blood return step, fluid replacement or blood return can be reliably performed.

  Further, provided that the air bubble is detected by the air bubble detecting means 10, a clamp means 12 capable of clamping and closing the flow path held by the holding means H is provided. Since the closed state can prevent the liquid from flowing in the flow path, the function of preventing air bubbles from reaching the patient's body by the air bubble detection means 10 and the clamp means 12 can be used to detect negative pressure. The process can be performed.

  Further, the bubble detecting means 10 is provided at the distal end of the arterial blood circuit 1a, and is provided between the blood pump 3 and the bubble detecting means 10 provided in the arterial blood circuit 1a. A replenisher supply line L8 for introducing a replenisher to be replenished into the circuit 1 into the blood circuit 1 is connected, and the blood pump 3 is driven to rotate forward while the flow path is closed by the clamp means 12, Since the negative pressure detection step can be performed while the replenisher (dialysis fluid) is being introduced from the replenisher introduction line L8, it is possible to detect blockage of the flow path at the distal end of the replenisher introduction line L8 and the arterial blood circuit 1a. . In particular, the replenisher introduction line L8 has a base end connected to a dialysate introduction line L1 for introducing a dialysate into the dialyzer 2 (blood purification means), and the dialysate as a replenisher is supplied from the dialysate introduction line L1 to the blood. Since it can be introduced into the circuit 1, it can be applied to a blood purification device that uses a dialysate as a replenisher.

  Although the present embodiment has been described above, the present invention is not limited to this. For example, as shown in FIG. 12, the replenishment solution introduction line has a storage bag B whose base end stores a predetermined volume of physiological saline. And a replenisher supply line L9 that is capable of introducing a physiological saline solution as a replenisher from the storage bag B into the blood circuit 1. In this case, the replenisher introduction line L9 is configured such that the distal end thereof is connected between the holding means H and the blood pump 3 in the arterial blood circuit 1a and includes a clamp means V11, and the clamp means V11 is opened. By setting the state, a physiological saline solution as a replenishing solution can be introduced into the blood circuit 1 from the storage bag B, so that the present invention can be applied to a blood purification apparatus using a physiological saline solution as a replenishing solution.

  In the present embodiment, the bubble detecting means 10, the blood discriminating means 11, and the clamping means 12 are provided in the holding means H. However, the bubble detecting means 10 is independently provided in the holding means H. Alternatively, only the bubble detection means 10 and the clamp means 12 may be provided in the holding means H. In the present embodiment, the present invention is applied to a dialysis device used during dialysis treatment. However, other devices that can purify a patient's blood while circulating it extracorporeally (for example, used in hemofiltration dialysis, hemofiltration, and AFBF). Blood purification device, plasma adsorption device, etc.).

Control means capable of performing a negative pressure detection step of oscillating ultrasonic waves from the oscillating means and receiving the ultrasonic waves by the receiving means in a state where there is no flow of liquid in the flow path sandwiched by the holding means, and negative pressure detection And a negative pressure detecting means capable of detecting a negative pressure of the flow path or the communicating flow path held by the holding means based on the ultrasonic wave received by the receiving means in the step, and closing the flow path by the clamp means As long as the blood purifying apparatus can be in a state where the liquid does not flow in the flow path by adopting the state described above, the present invention can be applied to an apparatus to which other functions are added.

Reference Signs List 1 blood circuit 1a arterial blood circuit 1b venous blood circuit 2 dialyzer (blood purification means)
Reference Signs List 3 blood pump 4 arterial air trap chamber 5 venous air trap chamber 6 double pump 7 water removal pump 8 pressurizing pump 9 degassing chamber 10 bubble detecting means 11 blood discriminating means 12 clamping means 13 control means 14 negative pressure detecting means H Clamping means

Claims (5)

A blood circuit having an arterial blood circuit and a venous blood circuit, and allowing the patient's blood to extracorporeally circulate from the tip of the arterial blood circuit to the tip of the venous blood circuit,
Blood purification means interposed between the arterial blood circuit and the venous blood circuit of the blood circuit to purify blood flowing through the blood circuit;
Clamping means capable of clamping a part of the blood circuit, an oscillating means capable of oscillating ultrasonic waves in a flow path sandwiched by the clamping means, and an ultrasonic wave oscillated from the oscillating means and transmitted or reflected through the flow path. A bubble detecting means having a receiving means capable of receiving, and capable of detecting bubbles in the liquid flowing through the flow path based on the ultrasonic waves received by the receiving means,
Clamping means capable of clamping and closing the flow path clamped by the clamping means, provided that bubbles are detected by the bubble detection means,
In a blood purification device equipped with
Control means capable of performing a negative pressure detection step of oscillating ultrasonic waves from the oscillating means in a state where there is no flow of liquid in the flow path sandwiched by the sandwiching means and receiving the ultrasonic waves by the receiving means,
In the negative pressure detecting step, based on the ultrasonic wave received by the receiving means, a negative pressure detecting means capable of detecting a negative pressure of the flow path or the communicating flow path held by the holding means,
As well as comprising a, by a state of closing the flow path in said clamping means, together with causing the negative pressure detecting step and in the flow path and the absence liquid flow in the bubble detection means A blood purification apparatus, wherein a detected air bubble is prevented from reaching a patient's body .   The negative pressure detection step may be performed during a replenishment step in which a replenisher is introduced into the blood circuit and the replenisher is infused into a patient to replenish the blood, or during a blood return step in which the blood in the blood circuit is returned to the patient. The blood purification apparatus according to claim 1, wherein:   The air bubble detecting means is provided at the tip of the arterial blood circuit, and is provided between the blood pump and the air bubble detecting means provided in the arterial blood circuit. A replenisher introduction line for introducing a replenisher into the blood circuit is connected, and the blood pump is rotated forward while the flow path is closed by the clamp means, whereby the replenisher introduction line is provided. The blood purification apparatus according to claim 1 or 2, wherein the negative pressure detecting step can be performed while introducing a replacement liquid from the apparatus.   The replenisher introduction line has a base end connected to a dialysate introduction line for introducing a dialysate into the blood purification means, and a dialysate as a replenisher can be introduced from the dialysate introduction line into the blood circuit. The blood purification apparatus according to claim 3, wherein:   The replenisher introduction line is connected at its base end to a storage bag containing a predetermined volume of physiological saline, and can introduce a physiological saline as a replenisher from the storage bag into the blood circuit. Item 4. The blood purification device according to Item 3.

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