JP6067620B2 - Blood purification equipment - Google Patents

Description

  The present invention relates to a blood purification apparatus for purifying a patient's blood while circulating it outside the body.

  A hemodialysis apparatus for performing dialysis treatment is normally connected to a blood circuit including an arterial blood circuit and a venous blood circuit for circulating a patient's blood extracorporeally, and an arterial blood circuit and a venous blood circuit, respectively. And a dialyzer as a blood purifier for purifying blood circulating outside the body, and a water removal pump capable of removing water by removing excess water in the blood flowing through the dialyzer. Blood purification treatment is possible while removing the blood to be removed.

  The amount of water to be removed at the time of water removal (water removal speed) is controlled by controlling the drive of the water removal pump. However, if rapid or excessive water removal is performed, the patient's circulating blood volume will be excessive. However, if the rate of water removal is slow, the entire treatment time may be extended and the patient may be burdened. For this reason, for example, by arranging a blood concentration sensor or the like in the arterial blood circuit, the concentration of blood circulating extracorporeally during treatment, in particular, the hematocrit value, which is the volume fraction of blood cells, is measured and monitored sequentially. And safe treatment can be performed.

  A hematocrit sensor for measuring a hematocrit value as such a blood concentration sensor is used. Such a hematocrit sensor includes, for example, a clamping unit that is attached to a predetermined position of a blood circuit and clamps a flexible tube as disclosed in Patent Document 1, and also uses light such as infrared rays for blood circulating outside the body. Is used, and the relationship (linear relationship) between the received light voltage and the hematocrit value generated when receiving the reflected light is used. During the treatment, a hematocrit value that is an index of blood concentration is sequentially measured by the hematocrit sensor, and using the measured hematocrit value, for example, a change rate (ΔBV) of the circulating blood volume can be obtained, It is used as a guide for water removal speed and water removal amount.

  The clamping means has a fitting groove that can fit the flexible tube constituting the blood circuit, and a lid portion that can hold the flexible tube fitted in the fitting groove from above and below. In the fitting groove, a detection switch for detecting the holding of the flexible tube is disposed. This detection switch is composed of a push button switch, and is configured such that when the flexible tube is fitted in the fitting groove and sandwiched between the lid portions, the detection switch is pressed through the flexible tube to turn on the switch. Therefore, it is possible to detect forgetting to set the flexible tube or forgetting to close the lid.

Japanese Patent Application Laid-Open No. 2004-97782

  However, in the conventional blood purification apparatus described above, a detection switch for detecting forgetting to set the flexible tube or forgetting to close the lid is required for the hematocrit sensor (index detection means). Therefore, the entire index detection means is enlarged by the amount of the detection switch, and if the sensitivity of the detection switch (for example, the pressing force required to turn on the switch) is insufficient, the blood circuit Forgetting to set the flexible tube or forgetting to close the lid cannot be detected with high accuracy.

  That is, the flexible tube constituting the blood circuit has various diameters, and the diameter may change depending on the temperature, so that the detection of the flexible tube by the detection switch is always performed with high accuracy. It has become difficult. Further, when a plurality of flexible tubes are clamped by the clamping means, a detection switch is required for each fitting groove, and there is a problem that the size of the apparatus becomes more remarkable. Such a problem is not limited to the hematocrit sensor, and may be caused in the same manner even if it is attached to a predetermined position of the blood circuit and can detect another predetermined index of blood flowing through the flow path at the predetermined position.

  The present invention has been made in view of such circumstances, and it is possible to avoid an increase in the size of the index detection means and accurately detect a state in which the flow path constituting the blood circuit is not attached to the index detection means. An object of the present invention is to provide a blood purification device that can perform the above.

The invention according to claim 1 is composed of an arterial blood circuit and a venous blood circuit, a blood circuit capable of extracorporeally circulating a patient's blood from the tip of the arterial blood circuit to the tip of the venous blood circuit, and the blood A blood purification means for purifying blood flowing between the arterial blood circuit and the venous blood circuit of the circuit, and a part of the arterial blood circuit disposed in the arterial blood circuit A blood pump capable of flowing blood from the tip of the arterial blood circuit to the tip of the venous blood circuit by driving, and attached to a predetermined position of the blood circuit. In a blood purification apparatus comprising an index detecting means capable of detecting a predetermined index of a liquid flowing through a channel at a predetermined position, the blood is driven while the blood pump is driven to cause the blood to flow. By detecting the change in the detection value of said index detecting means based on the presence or absence of pulsation of the pump, characterized in that may determine that the blood circuit to the index detecting means is attached.

  According to a second aspect of the present invention, in the blood purification apparatus according to the first aspect, the detection value by the index detection means is applied a plurality of times in a state in which the blood pump is driven to flow the liquid in the blood circuit. Based on the cumulative value acquired by the cumulative value acquisition means, the cumulative value acquired by the cumulative value acquisition means that obtains the cumulative value by sequentially obtaining the difference between the detection values, and accumulating the absolute value of the difference. And a determination unit capable of determining whether or not the index detection unit is attached to the blood circuit.

  According to a third aspect of the present invention, in the blood purification apparatus according to the first or second aspect, the indicator detecting means includes a light emitting means capable of irradiating light to the flow path at the predetermined position in the blood circuit, and the light emission. And a light receiving means capable of receiving the reflected light of the light from the means, and a predetermined index of blood flowing through the flow path can be detected based on the reflected light received by the light receiving means.

  According to a fourth aspect of the present invention, in the blood purification apparatus according to the first or second aspect, the index detection unit includes a light emitting unit capable of irradiating light to the flow path at the predetermined position in the blood circuit, and the light emission. And a light receiving means capable of receiving the transmitted light of the light from the means, and a predetermined index of blood flowing through the flow path can be detected based on the transmitted light received by the light receiving means.

  According to a fifth aspect of the present invention, in the blood purification apparatus according to any one of the first to fourth aspects, the index detecting means comprises a concentration sensor capable of detecting a parameter relating to a concentration of blood flowing through the blood circuit. It is characterized by that.

  According to a sixth aspect of the present invention, in the blood purification apparatus according to the second aspect, the index detection means includes a main body portion in which a fitting groove capable of fitting a part of the blood circuit is formed, and the main body portion. A lid portion that is openable and closable with respect to the blood groove fitted in the fitting groove in a closed state, and a detection switch that detects the open / closed state of the lid portion. The acquisition of the cumulative value by the cumulative value acquisition means is performed on condition that the closed state is detected by the detection switch.

  According to a seventh aspect of the present invention, in the blood purification apparatus according to any one of the first to sixth aspects, the blood pump is driven based on a detection value by the index detection means, and the blood circuit is connected to a patient's blood circuit. It is characterized in that it is possible to detect a blood removal failure when blood is introduced.

According to the first aspect of the present invention, the index detection means is detected by detecting the change in the detection value of the index detection means based on the presence or absence of pulsation of the blood pump while driving the blood pump and causing the liquid to flow in the blood circuit. Since it is possible to determine that the blood circuit is attached to the indicator circuit, it is possible to avoid an increase in the size of the indicator detection means and to accurately detect a state in which the flow path constituting the blood circuit is not attached to the indicator detection means. it can. That is, in the state where the blood pump is driven and the liquid is made to flow in the blood circuit, the detection value of the index detection means changes based on the presence or absence of the pulsation of the blood pump, so the change based on the presence or absence of the pulsation is detected. By doing so, it can be determined that the blood circuit is attached to the index detection means.

  According to the invention of claim 2, while the blood pump is driven and the liquid is made to flow in the blood circuit, the detection value by the index detection means is sequentially obtained a plurality of times, and the difference between the detection values is sequentially obtained. And determining whether or not the indicator detection means is attached to the blood circuit based on the cumulative value acquired by the cumulative value acquisition means and the cumulative value acquisition means that can acquire the cumulative value by accumulating the absolute value of the difference. Since the determination means which can determine is provided, the change based on the pulsation of the blood pump can be detected with higher accuracy.

  According to the invention of claim 3, the index detecting means has a light emitting means capable of irradiating light to a flow path at a predetermined position in the blood circuit, and a light receiving means capable of receiving reflected light of the light from the light emitting means. In addition, since the predetermined index of the blood flowing through the flow path can be detected based on the reflected light received by the light receiving means, the blood purification apparatus provided with the index detecting means capable of detecting the predetermined index of blood based on the reflected light It can be determined whether or not a blood circuit is attached to the index detection means.

  According to the invention of claim 4, the index detecting means has a light emitting means capable of irradiating light to a flow path at a predetermined position in the blood circuit, and a light receiving means capable of receiving transmitted light from the light emitting means. And a blood purification apparatus including an index detection unit capable of detecting a predetermined index of blood based on the transmitted light because the predetermined index of blood flowing through the flow path can be detected based on the transmitted light received by the light receiving unit. It can be determined whether or not a blood circuit is attached to the index detection means.

  According to the invention of claim 5, since the index detecting means is composed of a concentration sensor capable of detecting a parameter relating to the concentration of blood flowing in the blood circuit, the index detecting means is provided in the blood purification apparatus having the index detecting means comprising the concentration sensor. It can be determined whether a blood circuit is attached to the means.

  According to the invention of claim 6, the index detecting means has a main body portion formed with a fitting groove capable of fitting a part of the blood circuit, and can be opened and closed with respect to the main body portion. The accumulator includes a lid part capable of sandwiching a part of the blood circuit fitted in the fitting groove, and a detection switch for detecting the open / closed state of the lid part, Since the detection is performed on the condition that the detection switch is closed, it is possible to prevent the determination unit from determining whether or not the indicator detection unit is attached to the blood circuit when the lid is in the open state.

  According to the seventh aspect of the present invention, it is possible to detect a blood removal failure when the blood pump is driven to guide the patient's blood to the blood circuit based on the detection value by the index detection means. In addition to the determination of whether or not is attached, it is also possible to detect poor blood removal.

The schematic diagram which shows the blood purification apparatus which concerns on embodiment of this invention. Side view showing bubble detecting means in the blood purification apparatus Front view showing the bubble detection means IV-IV line sectional view in FIG. Sectional drawing which shows the blood discrimination means arrange | positioned at the clamping means in the bubble detection means (VV sectional view taken on the line in FIG. 2) Sectional drawing which shows the bubble detection means (The state by which the clamping means is not made) (VI-VI sectional view taken on the line in FIG. 2) Sectional drawing which shows the bubble detection means (state clamped by the clamping means) Front view showing index detecting means in the blood purification apparatus IX-IX sectional view in FIG. XX sectional view in FIG. The graph which shows the detection value (the state where the blood circuit was attached) by the index detection means The graph which shows the detection value (the state where the blood circuit is not attached) by the same index detection means The graph which shows the state (state with the blood circuit attached) which accumulated the absolute value of the difference of the detected value by the same index detection means The graph which shows the state (the state where the blood circuit is not attached) which accumulated the absolute value of the difference of the detected value by the index detecting means The flowchart which shows the control content in the blood purification apparatus which concerns on this embodiment.

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The blood purification apparatus according to this embodiment includes a dialysis apparatus for performing dialysis treatment. As shown in FIG. 1, a blood circuit including an arterial blood circuit 1 and a venous blood circuit 2, and an arterial blood circuit 1. And a dialyzer 3 (blood purification means) interposed between the venous blood circuit 2 and purifying blood flowing through the blood circuit, a blood pump 4, and an air trap chamber 5 disposed in the venous blood circuit 2. The dialysis apparatus main body 6 that can supply dialysate 3 to the dialyzer 3, the bubble detection means 7, the blood discrimination means 8, and the index detection means 10 are mainly configured.

  An arterial puncture needle a can be connected to the distal end of the arterial blood circuit 1 via a connector, and an iron-type blood pump 4 is disposed in the middle. The venous puncture needle b can be connected to the tip thereof via a connector, and the air trap chamber 5 is connected in the middle. The air trap chamber 5 is formed with an air layer, which can capture bubbles in the liquid and is provided with a filtration network (not shown) so that, for example, blood clots can be captured when returning blood. It has become.

  The blood pump 4 is composed of a squeezing type pump disposed in the arterial blood circuit 1 and is capable of normal rotation and reverse rotation, and can flow the liquid in the blood circuit in the driving direction. That is, the arterial blood circuit 1 is connected to a corrugated tube (part of the arterial blood circuit 1) that is softer and larger in diameter than the other flexible tubes constituting the arterial blood circuit 1. The blood pump 4 is provided with a roller for rubbing the ironing tube in the liquid feeding direction. When the blood pump 4 is driven, the roller rotates to handle the ironing tube in the liquid feeding direction, and the liquid inside can flow in the driving direction (rotating direction of the roller).

  Thus, when the blood pump 4 is driven to rotate forward (left rotation in the figure) with the artery side puncture needle a and the vein side puncture needle b being punctured into the patient, the patient's blood passes through the artery side blood circuit 1. After reaching the dialyzer 3, blood purification is performed by the dialyzer 3, and air bubbles are removed in the air trap chamber 5 and returned to the patient's body through the venous blood circuit 2. That is, the blood of the patient is purified by the dialyzer 3 while circulating externally from the tip of the arterial blood circuit 1 to the tip of the venous blood circuit 2 of the blood circuit. Further, when the blood pump 4 is driven in the reverse direction (right rotation in the figure), the blood in the blood circuit (between the distal end of the arterial blood circuit 1 and the position where the blood pump 4 is disposed) can be returned to the patient. .

  The dialyzer 3 is formed with a blood introduction port 3a, a blood outlet port 3b, a dialysate inlet port 3c, and a dialysate outlet port 3d in the casing. Among these, the blood inlet port 3a includes the arterial blood circuit 1. However, the venous blood circuit 2 is connected to the blood outlet port 3b. The dialysate introduction port 3c and the dialysate lead-out port 3d are connected to a dialysate introduction line L1 and a dialysate discharge line L2 extending from the dialyzer body 6, respectively.

  A plurality of hollow fibers are accommodated in the dialyzer 3, the inside of the hollow fibers is used as a blood flow path, and the flow of dialysate is between the hollow fiber outer peripheral surface and the inner peripheral surface of the housing. It is considered a road. A hollow fiber membrane is formed in the hollow fiber by forming a large number of minute holes (pores) penetrating the outer circumferential surface and the inner circumferential surface, and impurities in the blood are passed through the membrane in the dialysate. It is comprised so that it can permeate | transmit.

  On the other hand, the dialyzer body 6 is provided with liquid feeding means such as a dual pump over the dialysate introduction line L1 and the dialysate discharge line L2, and a bypass line that bypasses the liquid feeding means has a dialyzer. 3 is provided with a water removal pump for removing water from the blood of the patient flowing through the body 3. Furthermore, one end of the dialysate introduction line L1 is connected to the dialyzer 3 (dialyte introduction port 3c), and the other end is connected to a dialysate supply device (not shown) for preparing a predetermined concentration of dialysate. One end of the dialysate discharge line L2 is connected to the dialyzer 3 (dialysate outlet port 3d), and the other end is connected to a drain means (not shown). The dialysate supplied from the dialysate supply device After reaching the dialyzer 3 through the dialysate introduction line L1, it is sent to the drainage means through the dialysate discharge line L2.

  A pressure sensor is connected to the air trap chamber 5 via a monitor tube so that the fluid pressure (venous pressure) in the air trap chamber 5 can be measured. An overflow line is extended from the upper part (air layer side) of the air trap chamber 5, and an electromagnetic valve is disposed in the middle of the overflow line. By opening the electromagnetic valve, the liquid (priming liquid or the like) flowing in the blood circuit can overflow through the overflow line.

  Further, in the vicinity of the vein-side puncture needle b in the vein-side blood circuit 2 (near the tip of the vein-side blood circuit 2 and between the air trap chamber 5 and the vein-side puncture needle b), there are bubble detection means 7, blood A discriminating means 8 and a clamping means 9 (for example, an electromagnetic valve) are provided. These bubble detection means 7, blood discrimination means 8 and clamp means 9 are provided with a common clamping means H. The clamping means H is composed of a unit disposed at the distal end portion of the venous blood circuit 2 and has a main body portion Ha and a lid portion Hb. The main body portion Ha includes a venous side. A fitting groove Haa capable of fitting a flexible tube constituting the blood circuit 2 is formed. The lid Hb is swingably attached to the main body Ha via a swing shaft L, and can be opened and closed by swinging about the swing shaft L.

  Then, by closing the lid Hb with the flexible tube fitted in the fitting groove Haa, as shown in FIG. 7, the flexible tube ( A part of the blood circuit) can be sandwiched from above and below. Further, 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 by the fitting groove Haa. Thereby, it is possible to detect whether or not the flexible tube is normally held in the fitting groove Haa.

  Further, the lid portion Hb is formed with a lock portion Hba that can be engaged with the main body portion Ha in the closed state, and the state in which the flexible tube is sandwiched is securely held by the lock by the lock portion Hba. The The bubble detecting means 7, the blood discriminating means 8 and the clamping means 9 are arranged along the extending direction of the fitting groove Haa in the main body portion Ha, and a part of the blood circuit held by the holding means H. On the other hand, the bubble detection means 7 can detect the bubbles, the blood determination means 8 can determine the blood, and the clamp means 9 can open and close the flow path.

  The clamp means 9 is capable of closing and opening the flow path (that is, the flow path at the distal end portion of the venous blood circuit 2) in each of the disposed portions by opening and closing operations. 4 indicates a push rod disposed in the clamp means 9, and the push rod R is moved forward and backward with respect to the fitting groove Haa to close and open the flow path at a predetermined position. It has come to be able to do.

  The blood discriminating means 8 is for discriminating whether or not blood is circulating in the flow path at the distal end of the venous blood circuit 2, and as shown in FIG. And a light receiving element A2. The light emitting element A1 and the light receiving element A2 are arranged on the left and right sides of the fitting groove Haa, respectively, and directed toward the flexible tube constituting the venous blood circuit 2 fitted in the fitting groove Haa. Thus, the light can be irradiated from the light emitting element A1, and the light can be received by the light receiving element A2.

  The light receiving element A2 is configured such that the voltage changes according to the amount of light received, and is configured to be able to determine the presence or absence of blood flowing through the venous blood circuit 2 based on the detected voltage. That is, the transmittance of light emitted from the light emitting element A1 is different between blood and the replacement fluid (in this embodiment, physiological saline) (the replacement fluid such as physiological saline has a light transmittance higher than that of blood). Therefore, when the voltage detected by the light receiving element A2 exceeds a predetermined threshold value, it is detected that the flowing liquid is replaced with the replacement liquid from the blood.

  The bubble detection means 7 includes a sensor capable of detecting bubbles (air) flowing through the venous blood circuit 2 at a portion (predetermined position) held by the holding means H. As shown in FIG. And an ultrasonic receiving element A4 (receiving means) made of a piezoelectric element. The ultrasonic vibration element A3 (oscillating means) is disposed below the fitting groove Haa in the main body portion Ha, and can oscillate ultrasonic waves in the flow path sandwiched by the sandwiching means H. The ultrasonic receiving element A4 (receiving means) is disposed in a predetermined part of the lid Hb (a part facing the ultrasonic vibration element A3 when the lid Hb is closed), and the ultrasonic receiving element The ultrasonic wave oscillated from A4 and transmitted through the flow path can be received.

  And while being able to irradiate an ultrasonic wave from the ultrasonic vibration element A3 toward the flexible tube which comprises the vein side blood circuit 2 fitted by fitting groove Haa, the vibration is ultrasonic reception element A4. It can be received. The ultrasonic receiving element A4 is configured so that the voltage changes according to the received vibration, and the fact that the bubble has flowed to the venous blood circuit 2 due to the detected voltage exceeding a predetermined threshold value. It is configured so that it can be detected.

  The bubble detection means 7 configured as described above can detect bubbles in the liquid flowing through the flow path based on the ultrasonic waves received by the ultrasonic reception element A4 (reception means). Thus, according to the present embodiment, blood purification treatment is performed by the dialyzer 3 while circulating the patient's blood extracorporeally in the arterial blood circuit 1 and the venous blood circuit 2, and the blood discrimination means 8 performs predetermined processing When it is detected that the fluid flowing through the position has been replaced with the replacement liquid from the blood, or when the bubble detection means 7 detects the flow of the bubbles, the clamp means 9 is closed to terminate or interrupt the dialysis treatment or blood return. Can do.

  The index detection means 10 is attached to a predetermined position of the arterial blood circuit 1 and the venous blood circuit 2, irradiates light to the blood flowing through the arterial blood circuit 1 and the venous blood circuit 2, and its reflected light. The blood concentration (hematocrit value (hereinafter also abbreviated as “Ht”)) can be measured based on the received light voltage obtained by receiving light, and as shown in FIGS. Light-emitting elements A5 to A8 (light-emitting means) that can irradiate light to the flow path at predetermined positions, and light-receiving elements A9 and A10 (light-receiving means) that can receive reflected light from the light-emitting elements A5 to A8. In addition, the hematocrit value (predetermined index) of the blood flowing through each flow path can be detected based on the reflected light received by the light receiving elements A9 and A10.

  In addition, the index detection means 10 according to the present embodiment can be opened and closed with respect to the main body portion Ia in which fitting grooves Ia1 and Ia2 into which a part of the blood circuit can be fitted, and the main body portion Ia. The clamping means I is formed with a lid Ib that can clamp a part of the blood circuit fitted in the fitting grooves Ia1 and Ia2 in a state and a detection switch g that detects the open / closed state of the lid Ib. For example, a predetermined position of the arterial blood circuit 1 can be fitted into the fitting groove Ia1 and a predetermined position of the venous blood circuit 2 can be fitted into the fitting groove Ia2.

  The lid portion Ib is swingably attached to the main body portion Ia via the swing shaft M, and can be opened and closed by swinging around the swing shaft M, and the main body in the closed state. A lock portion Iba that can be engaged with the portion Ia is formed, and the state in which the flexible tube is clamped is securely held by the lock by the lock portion Iba. Then, by closing the lid Ib in a state where the flexible tubes at the predetermined position of the arterial blood circuit 1 and the predetermined position of the venous blood circuit 2 are fitted in the fitting grooves Ia1 and Ia2, The flexible tube (part of the blood circuit) can be sandwiched from above and below by the main body portion Ia and the lid portion Ib.

  The detection switch g includes a push button switch formed between the fitting groove Ia1 and the fitting groove Ib2 in the main body portion Ia, and the lid portion Ib swings about the swing shaft M, and the main body portion Ia. If it approaches, it will be pressed and turned on by the convex part Ibb formed in the said cover part Ib. The open / closed state of the lid Ib can be detected by turning on and off the detection switch g.

  Furthermore, slits α and β are formed in the fitting grooves Ia1 and Ia2 in the main body Ia, respectively. The slits α and β are formed by cutting out the bottom surfaces of the fitting grooves Ia1 and Ia2, and are formed over a predetermined dimension in the extending direction of the fitting grooves Ia1 and Ia2. A pair of light emitting elements A5, A6 and a light receiving element A9 are formed on the inner side of the slit α in the main body Ia, and a pair of light emitting elements A7, A8 and a light receiving element A10 are formed on the inner side of the slit β. The light emitted from the pair of light emitting elements A5 and A6 and the pair of light emitting elements A7 and A8 is reflected by the liquid in the arterial blood circuit 1 and the venous blood circuit 2 through the slits α and β, and received. The elements A9 and A10 can receive light (so-called reflection type sensor structure).

  The light-emitting elements A5 to A8 are made of LEDs (near-infrared LEDs) that can irradiate near infrared rays having a wavelength of about 805 ± 15 nm, and the light receiving elements A9 and A10 are made of photodiodes. The light emitting elements A5 to A8 and the light receiving elements A9 and A10 are formed on a single substrate so as to be spaced apart from each other by a predetermined dimension. When the flexible tube fitted in the fitting grooves Ia1 and Ia2 or the flexible tube is not fitted, the reflecting portions Ibc and Ibd) formed on the lid portion Ib can be seen. .

  An amplifier circuit for amplifying signals from the light receiving elements A9 and A10 is formed on the substrate on which the light emitting elements A5 to A8 and the light receiving elements A9 and A10 are attached. Accordingly, when the light receiving elements A9 and A10 receive light and output an electrical signal corresponding to the illuminance, the light can be amplified by the amplifier circuit. Furthermore, in this embodiment, since near-infrared LED is used as light emitting element A5-A8, the light of the wavelength which does not change the light absorption factor of hemoglobin can be irradiated, and it influences the oxygenated state of the said hemoglobin The hematocrit value can be measured accurately at all times. In the figure, symbols Aa and Ab indicate light emitting elements (LEDs) for measuring oxygen saturation and the like.

  Thus, based on the electrical signals output from the light receiving elements A9 and A10, the hematocrit value indicating the blood concentration can be obtained. That is, each component of blood such as red blood cells and plasma has its own light absorption characteristics, and this property is used to quantify the red blood cells necessary for measuring the hematocrit value electro-optically. Thus, the hematocrit value can be obtained. Specifically, near-infrared rays emitted from the light-emitting elements A5 to A8 are affected by absorption and scattering when reflected on blood, and are received by the light-receiving elements A9 and A10. The light absorption / scattering rate is analyzed from the intensity of the received light, and the hematocrit value is calculated.

Then, using this calculated hematocrit value, ΔBV (%) = (Ht ₀ / Ht _t −1) × 100 (where Ht ₀ is the hematocrit value at the initial stage of treatment, and Ht _t is the hematocrit at the time of measurement) The rate of change of the circulating blood volume (ΔBV) is determined by the value), and the rate of change of the circulating blood volume (ΔBV) is used as a measure of the water removal speed and water removal amount. Based on the hematocrit value calculated in this way (or including various parameters such as the circulating blood volume change rate ΔBV further calculated from the hematocrit value), the drive of the water removal pump is controlled to remove water in accordance with the condition of the patient. It can be speed and water removal. In the present embodiment, the water removal rate and the amount of water removal are controlled based on the measured hematocrit value. However, for example, the fluid replacement conditions and dialysate conditions in dialysis treatment are controlled based on the hematocrit value. May be.

  Further, in the dialysis apparatus main body 6 according to the present embodiment, a cumulative value acquisition means 11, a determination means 12 and a notification means 13 made of, for example, a microcomputer are disposed. The accumulated value acquisition unit 11 drives the blood pump 4 to cause the blood flow (the arterial blood circuit 1 and the venous blood circuit 2) to flow the liquid, and the detection value obtained by the index detection unit 10 is applied a plurality of times. And sequentially obtaining the difference between the detected values and accumulating the absolute value of the difference to obtain the accumulated value.

  That is, when the blood pump 4 is driven in a state where the arterial blood circuit 1 and the venous blood circuit 2 are attached to the index detecting means 10 (fitting grooves Ia1, Ia2), as shown in the graph of FIG. The hematocrit value detected by the detecting means 10 changes with a change in blood concentration, and the change changes in small increments (changes up and down per minute time) as the blood pump 4 pulsates. Therefore, the detected value is sequentially acquired a plurality of times, the difference (ΔHt) between the detected values is sequentially obtained, and the absolute value (| ΔHt |) of the difference is accumulated to obtain a cumulative value (Σ | By obtaining ΔHt |), as shown in the graph of FIG. 13, it is possible to obtain a transition that rises with time.

  On the other hand, when the blood pump 4 is driven in a state where the arterial blood circuit 1 and the venous blood circuit 2 are not attached to the index detection means 10 (fitting grooves Ia1, Ia2), as shown in the graph of FIG. The detection value by the index detection means 10 changes without change, and the change does not change little by little (up and down per minute time) with the pulsation of the blood pump 4. Therefore, the detected value is sequentially acquired a plurality of times, the difference (ΔHt) between the detected values is sequentially obtained, and the absolute value (| ΔHt |) of the difference is accumulated to obtain a cumulative value (Σ | By obtaining ΔHt |), as shown in the graph of FIG. 14, it is possible to obtain a transition that hardly changes with time.

  In the cumulative value acquisition unit 11 according to the present embodiment, the cumulative value is acquired for the hematocrit value detected by the index detection unit 10, but the circulating blood volume change rate that is further calculated from the hematocrit value. A cumulative value of various parameters such as ΔBV may be acquired, and the determination unit 12 may determine whether or not the index detection unit 10 is attached to the blood circuit.

  Based on the cumulative value (Σ | ΔHt |) acquired by the cumulative value acquisition unit 11, the determination unit 12 determines whether the index detection unit 10 is attached to the blood circuit (arterial blood circuit 1 and venous blood circuit 2). It can be determined whether or not. That is, as shown in FIG. 13, when the cumulative value (Σ | ΔHt |) acquired by the cumulative value acquisition unit 11 exceeds a preset threshold value k within a predetermined time, the index detection unit 10 (fitting groove Ia1, It is determined that the arterial blood circuit 1 and the venous blood circuit 2 are attached to Ia2), and the cumulative value (Σ | ΔHt |) acquired by the cumulative value acquiring means 11 is previously determined as shown in FIG. If the set threshold value k is not exceeded within a predetermined time, it can be determined that the arterial blood circuit 1 and the venous blood circuit 2 are not attached to the index detection means 10 (fitting grooves Ia1, Ia2). .

  The notifying means 13 does not cause the accumulated value (Σ | ΔHt |) acquired by the accumulated value acquiring means 11 to exceed a preset threshold value k within a predetermined time, and causes the index detecting means 10 (fitting grooves Ia1, Ia2) to receive an artery. When the determination means 12 determines that the side blood circuit 1 and the venous blood circuit 2 are not attached, a predetermined notification (notification that the arterial blood circuit 1 and the venous blood circuit 2 are not attached) is given. Is what you do.

  Thus, in the present embodiment, the blood circuit is attached to the index detection means 10 by detecting the change in the detection value of the index detection means 10 while driving the blood pump 4 and causing the blood circuit to flow the liquid. Since it is possible to determine whether or not the indicator detection unit 10 is large, it is possible to accurately detect a state in which the flow path constituting the blood circuit is not attached to the indicator detection unit 10. That is, in the state where the blood pump 4 is driven and the liquid is caused to flow in the blood circuit, the detection value of the index detection means 10 changes based on the pulsation of the blood pump 4, and thus a change based on the pulsation is detected. Thus, it is possible to determine whether or not a blood circuit is attached to the index detection means 10.

  Further, according to the present embodiment, the detection value by the index detection means 10 is sequentially acquired a plurality of times while the blood pump 4 is driven and the liquid is caused to flow in the blood circuit, and the difference between the detection values is obtained. Are obtained sequentially, and the absolute value of the difference is accumulated to obtain a cumulative value, and based on the cumulative value obtained by the cumulative value obtaining means 11, the index detecting means 10 is attached to the blood circuit. Since the determination means 12 that can determine whether or not the blood pump 4 is provided, a change based on the pulsation of the blood pump 4 can be detected with higher accuracy.

  Furthermore, the index detection means 10 according to the present embodiment includes light emitting elements A5 to A8 (light emitting means) that can irradiate light at a predetermined position in the blood circuit and light from the light emitting elements A5 to A8 (light emitting means). And a predetermined index (hematocrit value) of blood flowing through the flow path based on the reflected light received by the light receiving elements A9 and A10. Therefore, in the blood purification apparatus including the index detection unit 10 that can detect the predetermined index of blood based on the reflected light, it is possible to determine whether or not the blood circuit is attached to the index detection unit 10.

  In particular, since the index detection means 10 according to the present embodiment is composed of a concentration sensor (hematocrit sensor) that can detect a parameter (hematocrit value) relating to the concentration of blood flowing in the blood circuit, the index detection means 10 includes a concentration sensor. In the blood purification apparatus, it is possible to determine whether or not a blood circuit is attached to the index detection means 10. Although the present embodiment is applied to a hematocrit sensor that can detect a hematocrit value, it may be applied to a concentration sensor that can detect other parameters related to the concentration of blood flowing in the blood circuit.

  Further, the cumulative value acquisition (Σ | ΔHt |) by the cumulative value acquisition unit 11 according to the present embodiment is performed on the condition that the detection state of the closed state by the detection switch g formed in the clamping unit I of the index detection unit 10 is detected. It is configured as follows. With this configuration, when the lid portion Ib of the sandwiching means I is in the open state (that is, when the operator finds that the blood circuit is not attached to the index detecting means 10 at first glance), the index detecting means 10 It can prevent that the determination means 12 determines whether it is attached to.

  Further, based on the detection value by the index detection means 10, the blood pump 4 may be driven to detect a blood removal failure when the patient's blood is guided to the blood circuit. That is, for example, by providing an upper limit value for the threshold value of the detection value by the index detection means 10, it is possible to detect a blood removal failure by detecting a change in the pulsation of the blood pump 4. In this case, in addition to the determination of whether or not the blood circuit is attached to the index detection means 10, it is also possible to detect a blood removal failure.

Next, control of the blood purification apparatus according to the present embodiment will be described based on the flowchart of FIG.
First, on condition that the detection switch g is turned on, the blood pump 4 is driven, and the voltage (light reception voltage by the light receiving elements A9 and A10) detected by the index detection means 10 is acquired (S1). Based on this, a hematocrit value (blood concentration) is calculated (S2). Thereafter, a difference (ΔHt = Ht (t) −Ht (t−1)) of the calculated detection value is obtained (S3), and an absolute value (| ΔHt |) of the difference is accumulated to obtain a cumulative value (Σ | ΔHt |) Is acquired (S4).

  Then, it is determined whether or not a predetermined time has passed (S5), and S1 to S4 are repeatedly performed until the predetermined time has passed. If it is determined in S5 that the predetermined time has elapsed, it is determined whether or not the acquired accumulated value (Σ | ΔHt |) is equal to or greater than a predetermined value (for example, threshold k) (S6), and the accumulated value (Σ | ΔHt). If |) is greater than or equal to a predetermined value, it is determined that the blood circuit is attached to the index detection means 10 (S7), and if the cumulative value (Σ | ΔHt |) is less than the predetermined value, the index detection means It is determined that the blood circuit is not attached to 10 (S8).

  As described above, when the series of control is completed and the determination in S8 is made, the notification by the notification unit 13 is performed. In this embodiment, the start condition of such control is that the detection switch g is turned on. For example, dialysis treatment starts at the start of dialysis operation, blood removal, or blood discrimination by the blood discrimination means 8. It is good also as a condition. Further, when calculating the cumulative value in S4, noise removal processing (for example, ignoring ΔHt below a predetermined value) may be performed, or when it is determined that the blood circuit is not attached in S8, immediately. It may be determined again whether or not the blood circuit is attached by performing an operation that affects the light reception voltage of the index detection means 10 such as changing the driving speed of the blood pump 4 without notification.

  Although the present embodiment has been described above, the present invention is not limited to this. For example, any other index detecting unit that can detect pulsation caused by driving the blood pump 4 can be used. A sensor can be used. As such another sensor, for example, the bubble detection means 7 or the blood discrimination means 8 (however, it is necessary to be able to detect the quantitative amount) may be used, and the switch f may be eliminated. The index detecting means is not limited to the reflective optical sensor, and may be in various other forms (for example, an ultrasonic sensor such as a transmissive optical sensor or a bubble detecting means 7). .

  When a transmission type optical sensor is used as the indicator detection means, a light emitting means capable of irradiating light to a flow path at a predetermined position in the blood circuit, and light transmitted from the light emission means (flow path at a predetermined position of the blood circuit) And a light receiving means capable of receiving the light), and a predetermined index of blood flowing through the flow path can be detected based on the transmitted light received by the light receiving means. Thereby, in the blood purification apparatus provided with the index detection means that can detect the predetermined index of blood based on the transmitted light, it can be determined whether or not the blood circuit is attached to the index detection means.

  Further, the index detection means 10 does not have the detection switch g, or detects the open / closed state of the lid Ib in another form (for example, light emitting elements A5 to A8 (light emitting means), light receiving elements A9, A10). Or the like that optically detects the open / closed state of the lid Ib by a (light receiving means). Furthermore, the index detection means 10 according to the present embodiment is configured to detect an index (hematocrit value) of blood flowing through the flow paths while sandwiching the arterial blood circuit 1 and the venous blood circuit 2. Alternatively, an index (hematocrit value) of blood flowing through the flow path may be detected while holding the arterial blood circuit 1 or the venous blood circuit 2. In this embodiment, the present invention is applied to a dialysis apparatus used at the time of dialysis treatment, but is used in another apparatus that can purify the patient's blood while circulating it outside the body (for example, blood filtration dialysis, blood filtration, AFBF). The present invention may be applied to blood purification devices, plasma adsorption devices, and the like.

The blood circuit is attached to the index detection means by detecting the change in the detection value of the index detection means based on the presence or absence of pulsation of the blood pump while driving the blood pump to cause the liquid to flow in the blood circuit If it is a blood purification apparatus that can determine this, it can also be applied to devices to which other functions are added.

1 Arterial blood circuit 2 Venous blood circuit 3 Dialyzer (blood purification means)
4 Blood pump 5 Air trap chamber 6 Dialysis machine body 7 Bubble detection means 8 Blood discrimination means 9 Clamp means 10 Index detection means 11 Cumulative value acquisition means 12 Determination means 13 Notification means H Holding means I Holding means

Claims (7)

A blood circuit comprising an arterial blood circuit and a venous blood circuit, and capable of extracorporeally circulating the patient's blood from the distal end of the arterial blood circuit to the distal end of the venous blood circuit;
A blood purification means for purifying blood flowing between the arterial blood circuit and the venous blood circuit of the blood circuit and flowing through the blood circuit;
It is arranged in the arterial blood circuit and consists of a squeezing type pump that handles a part of the arterial blood circuit in the liquid feeding direction, and drives blood from the distal end of the arterial blood circuit to the distal end of the venous blood circuit. A blood pump that can flow;
Index detecting means attached to a predetermined position of the blood circuit and capable of detecting a predetermined index of the liquid flowing through the flow path at the predetermined position;
In the blood purification apparatus comprising
The blood circuit is connected to the index detection means by detecting the change in the detection value of the index detection means based on the presence or absence of pulsation of the blood pump while driving the blood pump and causing the liquid to flow in the blood circuit. A blood purification apparatus characterized by being able to determine that it is attached. While the blood pump is driven and the liquid is made to flow in the blood circuit, the detection value by the index detection means is sequentially acquired a plurality of times, the difference between the detection values is sequentially obtained, and the absolute value of the difference is obtained. Cumulative value acquisition means capable of accumulating values and acquiring cumulative values;
Determination means capable of determining whether or not the indicator detection means is attached to the blood circuit based on the cumulative value acquired by the cumulative value acquisition means;
The blood purification apparatus according to claim 1, comprising:   The indicator detecting means includes a light emitting means capable of irradiating light to the flow path at the predetermined position in the blood circuit, and a light receiving means capable of receiving reflected light of the light from the light emitting means. The blood purification apparatus according to claim 1 or 2, wherein a predetermined index of blood flowing through the flow path can be detected based on the received reflected light.   The indicator detecting means includes a light emitting means capable of irradiating light to the flow path at the predetermined position in the blood circuit, and a light receiving means capable of receiving transmitted light from the light emitting means. The blood purification apparatus according to claim 1 or 2, wherein a predetermined index of blood flowing through the flow path can be detected based on the received transmitted light.   The blood purification apparatus according to any one of claims 1 to 4, wherein the index detection means includes a concentration sensor capable of detecting a parameter relating to a concentration of blood flowing through the blood circuit. The index detecting means includes
A main body formed with a fitting groove into which a part of the blood circuit can be fitted;
A lid that is openable and closable with respect to the main body, and that is capable of clamping a part of the blood circuit fitted in the fitting groove in a closed state;
A detection switch for detecting the open / closed state of the lid,
The blood purification apparatus according to claim 2, wherein acquisition of the cumulative value by the cumulative value acquisition means is performed on condition that the closed state is detected by the detection switch.   7. The blood removal failure when the blood pump is driven and the blood of the patient is guided to the blood circuit can be detected based on a detection value by the index detection means. The blood purification apparatus according to one.

Images