JP5415038B2 - 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.

  In general, in blood purification therapy such as dialysis treatment, a blood circuit composed of a flexible tube is used to circulate a patient's blood extracorporeally. This blood circuit is mainly composed of an arterial blood circuit in which an arterial puncture needle for collecting blood from a patient is attached to the tip, and a venous blood circuit in which a venous puncture needle for returning blood to the patient is attached to the tip. The dialyzer is interposed between the arterial blood circuit and the venous blood circuit to purify blood circulating outside the body.

  In such a dialyzer, a plurality of hollow fibers are arranged inside, and blood passes through the inside of each hollow fiber, and on the outside thereof (between the outer peripheral surface of the hollow fiber and the inner peripheral surface of the housing). It is set as the structure which can flow a dialysate. The hollow fiber has a blood purification membrane with micropores (pores) formed in the wall surface, and waste products of blood passing through the hollow fiber permeate the blood purification membrane and are discharged into the dialysate. At the same time, waste blood is discharged and purified blood returns to the patient's body. In the dialysis machine, a water removal pump for removing water from the patient's blood is disposed, and water removal is performed during dialysis treatment.

  By the way, the dialysis patient forms a vascular access in order to secure a predetermined extracorporeal circulating blood volume. As an example of the vascular access, there is a shunt in which an artery and a vein are connected by a surgical operation. For example, when an arterial puncture needle and a venous puncture needle are punctured around a patient's shunt and its periphery to perform extracorporeal circulation, the blood purified from the venous puncture needle and returned to the patient's body is the patient's organ, etc. In some cases, blood recirculation may occur that is introduced again from the arterial puncture needle without passing through. When such blood recirculation occurs, the purified blood is further circulated extracorporeally, and the amount of extracorporeal blood that needs to be purified decreases accordingly, resulting in a problem that blood purification efficiency deteriorates. End up.

However, conventionally, a dialysis apparatus has been proposed that can detect blood recirculation by using a dehydration pump that is driven rapidly and only for a short period of time to give a unique peak to changes in the concentration of blood circulating outside the body. (For example, refer to Patent Document 1). According to the dialysis apparatus disclosed in this document, a sensor for detecting blood concentration (a sensor for detecting hemoglobin concentration) is disposed in the arterial blood circuit, and by detecting a specific peak with such a sensor, Blood recirculation during dialysis treatment can be detected.
Special Table 2000-502940

  However, although the above conventional blood purification apparatus can detect blood recirculation, it has the following problems. In other words, management of vascular access such as patient shunts in dialysis treatment is extremely important to ensure sufficient extracorporeal circulation blood flow. Thrombus formation, stenosis or occlusion is inevitable. However, blood recirculation occurs and sufficient extracorporeal blood flow cannot be secured, making it difficult to perform efficient treatment. Further, even if a minor vascular access abnormality occurs, there is a risk of causing a severe vascular access abnormality by overlooking it.

  The present invention has been made in view of such circumstances, blood purification that can easily and accurately perform vascular access management of a patient's shunt, etc., and can grasp vascular access abnormality early. To provide an apparatus.

The invention according to claim 1 is a blood circuit comprising an arterial blood circuit and a venous blood circuit for extracorporeally circulating a patient's blood, a blood pump disposed in the arterial blood circuit, and the arterial blood circuit. And a blood purification means for purifying blood flowing through the blood circuit, and blood returned to the patient from the vein blood circuit is led to the arterial blood circuit and flows again A blood purification apparatus comprising detection means for detecting recirculated blood and calculation means for obtaining a recirculation rate in the treatment from the recirculation blood detected by the detection means, wherein the blood purification apparatus is obtained by the calculation means storage means for storing a recirculation rate of each treatment, is chronologically display the recirculation rate of each stored therapy in the storage means, by Rukoto to grasp the temporal change of the recirculation rate of each treatment The patient's vascula Characterized by comprising a display means capable of grasping the abnormal access.

  According to a second aspect of the present invention, in the blood purification apparatus according to the first aspect, a determination unit that can determine that the recirculation rate for each treatment displayed on the display unit exceeds a predetermined set value, and the determination When it is determined by the means that the recirculation rate has exceeded a predetermined set value, a notifying means for notifying that is provided.

  According to a third aspect of the present invention, in the blood purification apparatus according to the second aspect, when the notification means determines that the recirculation rate exceeds a predetermined set value by the determination means, it automatically notifies that effect. It is possible to transmit to the outside.

  According to a fourth aspect of the present invention, in the blood purification apparatus according to any one of the first to third aspects, the storage means includes treatment conditions for each treatment, patient information, the arterial blood circuit, and the venous blood circuit. In addition to storing at least one additional information of a puncture person who has punctured a patient with a puncture needle attached to the tip, the display means, in addition to the time-series display of the recirculation rate stored in the storage means, The additional information can be displayed.

  According to the first aspect of the present invention, since the recirculation rate for each treatment stored in the storage means is displayed in time series on the display means, the vascular access management such as the patient shunt can be easily and accurately performed. It is possible to grasp vascular access abnormality at an early stage.

  According to the invention of claim 2, when the recirculation rate is determined by the determination means to exceed a predetermined set value, the notification means notifies that fact, so that vascular access abnormality can be detected early and more reliably. Can be grasped.

  According to the invention of claim 3, when it is determined by the determination means that the recirculation rate exceeds a predetermined set value, the notification means can automatically transmit that fact to the outside. Vascular access abnormalities can also be monitored at medical facilities.

  According to the invention of claim 4, the display means can display additional information such as treatment conditions in addition to the time-series display of the recirculation rate stored in the storage means. It is possible to perform multi-faceted access management, and to grasp vascular access abnormality more accurately.

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 purifying a patient's blood while circulating it extracorporeally, and is applied to a hemodialysis apparatus used in hemodialysis treatment. As shown in FIG. 1, the hemodialysis apparatus mainly includes a blood circuit 1 to which a dialyzer 2 as blood purification means is connected, and a dialyzer body 6 that removes water while supplying dialysate 2 to the dialyzer 2. Has been.

  As shown in the figure, the blood circuit 1 is mainly composed of an arterial blood circuit 1a and a venous blood circuit 1b made of a flexible tube. The arterial blood circuit 1a and the venous blood circuit 1b A dialyzer 2 is connected between them. The arterial blood circuit 1a has an arterial puncture needle a connected to the tip thereof, and an iron-type blood pump 3, a drip chamber 4a for defoaming, and a first detection means 5a disposed in the middle. Yes. On the other hand, a venous puncture needle b is connected to the distal end of the venous blood circuit 1b, and a second detection means 5b and a drip chamber 4b for removing bubbles are connected in the middle. The first detection means 5a and the second detection means 5b constitute the detection means of the present invention.

  When the blood pump 3 is driven with the patient punctured with the artery side puncture needle a and the vein side puncture needle b, the patient's blood passes through the artery side blood circuit 1a while being defoamed in the drip chamber 4a. To the dialyzer 2, blood purification is performed by the dialyzer 2, and defoaming is performed in the drip chamber 4 b to return to the patient's body through the venous blood circuit 1 b. That is, the blood of the patient is purified by the dialyzer 2 while circulating outside the body by the blood circuit 1.

  The dialyzer 2 is formed with a blood introduction port 2a, a blood outlet port 2b, a dialysate inlet port 2c, and a dialysate outlet port 2d in the casing. Among these, the blood inlet port 2a has an arterial blood circuit 1a. The base end of the venous blood circuit 1b is connected to the blood outlet port 2b. The dialysate introduction port 2c and the dialysate lead-out port 2d are connected to a dialysate introduction line 7 and a dialysate discharge line 8 extending from the dialyzer body 6, respectively.

  A plurality of hollow fibers are accommodated in the dialyzer 2, 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 is formed in the hollow fiber by forming a large number of minute holes (pores) penetrating the outer peripheral surface and the inner peripheral surface, and waste products in blood are dialyzed through the membrane. It is configured to be able to penetrate inside.

  On the other hand, the dialysis machine main body 6 mainly includes a duplex pump P, a bypass line 9 that bypasses the duplex pump P in the dialysate discharge line 8, and a dewatering pump 10 that is connected to the bypass line 9. It is configured. Among these, the dewatering pump 10 can give a peak peculiar to the change of the blood concentration by giving an artificial change to the blood of the patient circulating extracorporeally in the blood circuit 1. The dialysate discharge line 8 is provided with a pressurization pump (not shown) for flowing the dialysate from the dialyzer 2 to the drainage side of the dual pump P, for example. You may comprise so that a peak may be provided. In this case, the pressurizing pump is a non-volumetric pump (pressure control type) such as a centrifugal type.

  The compound pump P is disposed across the dialysate introduction line 7 and the dialysate discharge line 8 and introduces dialysate from the dialysate introduction line 7 to the dialyzer 2 (blood purification means). The dialysis fluid introduced into the dialysis fluid is discharged from the dialysis fluid discharge line 8. That is, the duplex pump P is composed of a fixed-quantity pump in which the supply side and the drainage side are substantially equal.

  One end of the dialysate introduction line 7 is connected to the dialyzer 2 (dialyte introduction port 2c), and the other end is connected to a dialysate supply device (not shown) for preparing a dialysate having a predetermined concentration. Further, one end of the dialysate discharge line 8 is connected to the dialyzer 2 (dialysate outlet port 2d), and the other end is connected to a drainage means (not shown), and supplied from the dialysate supply device. After the dialysate reaches the dialyzer 2 through the dialysate introduction line 7, it is sent to the drainage means through the dialysate discharge line 8 and the bypass line 9.

  The dewatering pump 10 is for removing water from the blood of the patient flowing through the dialyzer 2. That is, when the dewatering pump 10 is driven, since the dual pump P is of the fixed type, the volume of liquid discharged from the dialysate discharge line 8 is larger than the amount of dialysate introduced from the dialysate introduction line 7. Thus, water is removed from the blood by the large volume. In addition, you may make it remove a water | moisture content from a patient's blood by means other than this water removal pump 10 (for example, what utilizes what is called a balancing chamber etc.).

  The dewatering pump 10 in this embodiment (or a pressure pump (not shown), hereinafter the same) is abruptly driven in a short time, thereby concentrating the blood flowing through the dialyzer 2 rapidly and in a short time. The peak can be given. That is, the blood flowing through the blood flow path of the dialyzer 2 is concentrated by rapidly filtering the water through the blood purification membrane to the dialysate flow path side in a short time, and it appears as a unique peak. is there.

  The first detection means 5a and the second detection means 5b detect the blood index in the blood of the patient circulating extracorporeally in the blood circuit 1 over time, and artificial change (instantaneous blood concentration) given by the water removal pump 10 It is possible to detect a change in blood index (change in blood concentration) caused by (concentration). That is, the first detection means 5a and the second detection means 5b are disposed in the arterial blood circuit 1a and the venous blood circuit 1b, respectively, and blood concentration (specifically, hematocrit value) as a blood index flowing through these circuits. ) Is detected.

The first detection means 5a and the second detection means 5b are composed of a hematocrit sensor. The hematocrit sensor includes a light-emitting element such as an LED and a light-receiving element such as a photodiode, and irradiates light to the blood from the light-emitting element. In addition, the hematocrit value indicating the blood concentration of the patient is detected by receiving the transmitted or reflected light with a light receiving element.

  Specifically, a hematocrit value indicating the blood concentration is obtained based on the electrical signal output from the light receiving element. That is, each component such as red blood cell and plasma that constitutes blood has a specific light absorption characteristic, and by using this property, red blood cells necessary for measuring a hematocrit value are optically quantified. The hematocrit value can be obtained. More specifically, near infrared rays irradiated from the light emitting element are incident on blood, are affected by absorption and scattering, and are received by the light receiving element. The light absorption / scattering rate is analyzed from the intensity of the received light, and the hematocrit value is calculated.

  Since the first detection means 5a configured as described above is disposed in the arterial blood circuit 1a, it detects the hematocrit value of blood collected from the patient via the arterial puncture needle a during dialysis treatment. Since the second detection means 5b is disposed in the venous blood circuit 1b, the second detection means 5b detects the hematocrit value of the blood purified by the dialyzer 2 and returned to the patient. That is, the specific peak given by the water removal pump 10 is first detected by the second detection means 5b (see FIG. 2), and then when the blood reaches the artery side blood circuit 1a again and is recirculated, The first detection means 5a can detect the characteristic peak remaining in the recirculated blood (see FIG. 3).

  Thereby, it is possible to confirm whether or not a specific peak has been given by the second detection means 5b and to detect the presence or absence of recirculated blood by the first detection means 5a. In other words, since it is possible to confirm whether or not a specific peak has been given, parameters relating to patient blood access such as blood recirculation more reliably and accurately than those in which detection means are provided only in the arterial blood circuit. Can be detected.

  Further, as shown in FIG. 4, the first detection means 5a and the second detection means 5b are electrically connected to a calculation means 11 composed of a microcomputer or the like disposed in the dialyzer body 6. The calculation means 11 is for obtaining a recirculation rate (recirculation blood ratio) from the recirculation blood detected by the detection means (first detection means 5a and second detection means 5b) from a predetermined arithmetic expression. Specific operations will be described below.

  For example, the area of the change portion (the portion from t1 to t2 in FIG. 2) by the second detection means 5b is Sv, and the area of the change portion (the portion from t3 to t4 in FIG. 3) by the first detection means 5a is Sa. In other words, the ratio of recirculated blood (recirculation rate) Rrec is obtained by the following arithmetic expression.

  Rrec (%) = Sa / Sv × 100

  However, the time of the change portion (time interval from t3 to t4) by the first detection means 5a is diffused in the process in which the blood to which a specific peak is given flows from the second detection means 5b to the first detection means 5a. In consideration of the above, it is set to be larger than the time of the changed portion by the second detection means 5b (time interval from t1 to t2). The obtained ratio of recirculated blood (recirculation rate) is displayed on the display means 13 disposed in the dialyzer main body 6 so that medical personnel such as doctors can visually recognize it. When there is no blood recirculation, the above Sa is 0, so the numerical value displayed as the recirculated blood ratio is 0 (%).

  Further, the calculation means 11 is electrically connected to the storage means 12. The storage means 12 stores the recirculation rate for each treatment (in this embodiment, every treatment day, but this may be stored monthly or yearly) obtained by the computing means 11. For example, it is constituted by a memory having a predetermined storage capacity. The storage unit 11 may be a storage unit such as a personal computer separate from the dialysis machine body 6 or a storage medium that can be read by the dialysis machine 6 or an external device.

  The display means 13 is composed of a liquid crystal screen such as a touch panel provided in the dialysis apparatus 6, and is electrically connected to the storage means 12. As shown in FIG. 5 (particularly, the left line graph), the display means 13 can display the recirculation rate for each treatment stored in the storage means 12 in time series. Changes in the recirculation rate over time can be visually grasped, and abnormal vascular access can be grasped early. The display means 13 is electrically connected to a printing means 14 such as a printer, so that the display contents can be printed.

On the other hand, the storage means 12 in this embodiment includes “treatment conditions for each treatment (dialysis conditions)”, “patient information”, “puncture needles (arterial side) attached to the tips of the arterial blood circuit 1a and the venous blood circuit 1b. It is configured to store at least one additional information of “a puncture person who has punctured a patient with a puncture needle a and a vein-side puncture needle b)”. And Thus, the display unit 13, in addition to the time series representation of the recirculation rate stored in the storage unit 12 (line graph in FIG. 5 left side), capable of displaying additional information (a list of right-hand side in the figure) It is said that. As additional information displayed in the present embodiment, as shown in the figure, “patient name”, “puncture person”, “dialysis condition”, “basic access recirculation rate (RR)”, “sound”, “ Other ”.

  For example, when the “dialysis condition” (treatment condition) column on a specific date in the right-side list (see FIG. 5) displayed on the display means 13 is touched and operated, as shown in FIG. The dialysis conditions (blood flow rate Qb, water removal amount, water removal speed, blood pressure, pulse or blood data, etc.) are displayed. Further, when the “sound” column on a specific date in the list on the right side is touched and operated with a finger, a shunt sound pattern for the treatment date is displayed on the display means 13 as shown in FIG. When the “shunt” sound is output and the “other” column is touched and operated, an angiographic photograph (X-ray photograph) of the treatment date is displayed on the display means 13 as shown in FIG. You may comprise. Instead of the shunt sound, another vascular access sound (artificial blood vessel sound or the like) may be output.

  The display means 13 is electrically connected with a determination means 15 constituted by, for example, a microcomputer. This determination means 15 can determine that the recirculation rate for each treatment displayed on the display means 13 has exceeded a predetermined set value (lower limit value). For example, the recirculation rate is 10 to 15 (% ) Is exceeded, it is detected and it is determined that there may be an abnormality in the vascular access state.

  The determination unit 15 is electrically connected to a notification unit 16 having a transmission unit 17. When the determination unit 15 determines that the recirculation rate exceeds a predetermined set value, the notification unit 16 notifies the medical staff such as a doctor to that effect. As a form of notification, for example, an alarm is sounded by a speaker or the like, a warning is displayed on the display means 13 (may be displayed by a pop-up function), or a warning light is turned on or blinked.

  When the determination unit 15 determines that the recirculation rate has exceeded a predetermined set value, the transmission unit 17 automatically notifies the external medical facility (for example, as shown in FIG. It can be transmitted by e-mail, LAN, or the like to a personal computer M or the like in an external facility performing access shaping surgery other than the dialysis treatment room. In the figure, reference numerals N1 and N2 denote personal computers installed in the dialysis treatment room, and the screens of the personal computers N1 and N2 may be used as the display means 13 according to the present invention. Thereby, vascular access abnormality can be monitored also in an external medical facility. However, as long as the transmission means 17 transmits the fact that the recirculation rate exceeds the set value to the outside, other departments (for example, surgical departments, etc.) and medical workers (patients in charge of patients) in the same medical facility. ) Can also be transmitted.

  According to the above embodiment, the recirculation rate for each treatment stored in the storage unit 12 is displayed in time series on the display unit 13, so that the vascular access management such as the patient shunt can be easily and accurately performed. It is possible to grasp vascular access abnormality at an early stage. Further, when it is determined by the determination means 15 that the recirculation rate has exceeded a predetermined set value, the notification means 16 notifies that fact, so that vascular access abnormality can be grasped early and more reliably. it can.

  Furthermore, since the display means 13 can display additional information such as treatment conditions (dialysis treatment conditions) in addition to the time-series display of the recirculation rate stored in the storage means 12, a bus such as a patient shunt can be displayed. It is possible to perform multi-faceted access management, and to grasp vascular access abnormality more accurately. The additional information items to be displayed on the display means 13 can be arbitrarily set.

  As mentioned above, although this embodiment was described, this invention is not limited to this, For example, the time-sequential display of the recirculation rate for every treatment in the display means 13 may be any form, Instead of the line graph as in the embodiment, other displays such as a bar graph or a list format that can grasp changes with time may be used. The detecting means may be of any other form as long as it detects recirculated blood.

  However, as long as it can detect a specific peak imparted by rapid and short-time dehydration, it is possible to use a sensor other than a hematocrit sensor (for example, a sensor for detecting hemoglobin concentration or a sensor for detecting protein concentration, etc.). You may comprise 1 detection means and 2nd detection means. The first detection means and the second detection means may be arranged at any site as long as they are an arterial blood circuit and a venous blood circuit, respectively. Furthermore, the detection means may be arranged in either the arterial blood circuit or the venous blood circuit.

Further, in the present embodiment, the detection means (the first detection means 5a and the second detection means 5b) detect the hematocrit value, but detect other blood indicators (parameters related to blood). Also good. In the present embodiment, the storage unit 12, the determination unit 15, or the notification unit 16 is disposed in the dialyzer body 6, but any or all of these components are disposed outside the dialyzer body 6. (Which constitutes a system having the same function as that of the present embodiment as a whole). In this embodiment, the dialyzer body 6 is composed of a dialysis monitoring device in which the dialysate supply mechanism is not incorporated, but may be applied to a personal dialyzer in which a dialysate supply mechanism is incorporated. .

The storage means for storing the recirculation rate for each treatment obtained by the calculation means, and the recirculation rate for each treatment stored in the storage means are displayed in time series, and the change in the recirculation rate for each treatment over time is displayed. the Rukoto is grasped, if blood purification apparatus and a display means capable of grasping the abnormality of the vascular access of the patient, while extracorporeal circulation other therapies performing blood purification (hemofiltration therapy or hemodiafiltration It can also be applied to those used in therapy etc. or those with other functions added.

1 is an overall schematic view showing a blood purification apparatus according to an embodiment of the present invention. The graph which shows the change of the hematocrit value detected by the 2nd detection means in the blood purification apparatus The graph which shows the change (when there exists recirculation) of the hematocrit value detected by the 1st detection means in the blood purification apparatus The block diagram which shows the connection relationship of the 1st detection means in the blood purification apparatus, 2nd detection means, a calculation means, a memory | storage means, a display means, a determination means, a notification means, etc. The schematic diagram which shows the display content (Time series display of a recirculation rate, and the list of additional information) by the display means in the blood purification apparatus The schematic diagram which shows the display content (details of additional information) by the display means in the blood purification apparatus The schematic diagram which shows the display content (details of additional information) by the display means in the blood purification apparatus Schematic diagram showing display contents (details of additional information) by display means in the blood purification apparatus Schematic diagram showing the connection between the treatment room in the hospital and external facilities outside the hospital in the blood purification apparatus

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Blood circuit 1a ... Arterial side blood circuit 1b ... Vein side blood circuit 2 ... Dializer (blood purification means)
DESCRIPTION OF SYMBOLS 3 ... Blood pump 4 ... Drip chamber 5a ... 1st detection means (detection means)
5b ... 2nd detection means (detection means)
DESCRIPTION OF SYMBOLS 6 ... Dialyzer main body 7 ... Dialysate introduction line 8 ... Dialysis system discharge line 9 ... Bypass line 10 ... Dewatering pump 11 ... Calculation means 12 ... Storage means 13 ... Display means 14 ... Printing means 15 ... Determination means 16 ... Notification means 17 ... Transmission means P Duplex pump

Claims (4)

A blood circuit comprising an arterial blood circuit and a venous blood circuit for extracorporeal circulation of the patient's blood;
A blood pump disposed in the arterial blood circuit;
Blood purification means connected between the arterial blood circuit and the venous blood circuit and purifying blood flowing through the blood circuit;
Detection means for detecting recirculated blood that is returned to the patient from the venous blood circuit and then flows to the arterial blood circuit;
Calculation means for obtaining a recirculation rate in the treatment from the recirculated blood detected by the detection means;
A blood purification apparatus comprising:
Storage means for storing a recirculation rate for each treatment determined by the calculation means;
Chronologically display the recirculation rate of each stored therapy in the storage means, by Rukoto to grasp the temporal change of the recirculation rate of each treatment, capable of grasping the abnormality of the vascular access of the patient Display means;
A blood purification apparatus comprising: Determination means capable of determining that the recirculation rate for each treatment displayed by the display means exceeds a predetermined set value;
When it is determined by the determining means that the recirculation rate has exceeded a predetermined set value, notifying means for notifying that effect;
The blood purification apparatus according to claim 1, comprising:   3. The notification unit according to claim 2, wherein when the determination unit determines that the recirculation rate exceeds a predetermined set value, the notification unit can automatically transmit the fact to the outside. Blood purification device.   The storage means stores treatment conditions for each treatment, patient information, and at least one additional information of a puncture person who has punctured the patient with a puncture needle attached to the tip of the arterial blood circuit and the venous blood circuit, The said display means can display the said additional information in addition to the time-sequential display of the said recirculation rate memorize | stored in the said memory | storage means, The one of Claims 1-3 characterized by the above-mentioned. Blood purification device.

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