JP4857630B2 - Extracorporeal blood treatment equipment - Google Patents

Description

  The present invention relates to an extracorporeal circulation blood processing apparatus capable of detecting blood leakage from a human body in extracorporeal circulation blood processing, and an optical sensor capable of detecting blood leakage from a human body in extracorporeal circulation blood processing.

  Blood leakage from the human body may occur when a treatment or inspection is performed on the human body, but it is preferable from the viewpoint of avoiding adverse effects on the human body to detect this blood leak as quickly as possible. . In particular, extracorporeal circulating blood purification treatment that guides the patient's blood outside the body, purifies it, and returns it to the body has been put to practical use as hemodialysis therapy, which is an artificial kidney. Currently, in addition to the artificial kidney, an artificial heart lung, an artificial liver, a crystal separator, etc. It has been put to practical use. In such treatment methods, extracorporeal circulation blood purification treatment methods that derive a large amount of patient's blood and return it to the body after purification, since a large amount of blood is continuously taken out of the body and handled. It needs to be detected quickly, and delaying the detection of blood leaks can have serious consequences that can be life-threatening.

  For example, in hemodialysis, which is an extracorporeal blood purification treatment, a puncture needle is punctured on the moving / venous side, blood is continuously collected from one puncture needle, and blood is purified with a blood purifier, and then returned to the human body from the other puncture needle. Although the blood is spilled, accidents in which the puncture needle is withdrawn from the human body due to various causes during hemodialysis, such as natural withdrawal due to intense body movement of the patient, or self-withdrawing that the patient himself / herself withdraws. Since a needle withdrawal accident may occur, it is necessary to constantly monitor whether or not a needle withdrawal has occurred during dialysis.

In order to detect and detect a needle pulling accident as described above, a bipolar electrode is installed in the vicinity of the patient's puncture needle, and an alarm occurs when the bipolar electrode is short-circuited and energized by blood that has flowed out of the body due to the needle removal. Blood leak detection devices that generate alarms are known. As such a blood leak detection device, for example, it comprises a sensor part and an alarm part formed by sticking two upper and lower pieces of aluminum tape, and when the blood leaked from the needle touches the aluminum part of the sensor part, the sensor part Is known, a blood leak detection sensor in which an alarm is generated and an alarm is generated (Non-Patent Document 1).
Medical Industry Newspaper, May 14, 2004

  Since the blood leak detection method using the blood leak detection apparatus using the bipolar electrode as described above has a problem of giving the patient discomfort in terms of energizing a weak current to the patient, the present invention is thus It is in solving the problem.

  The first of the present invention is an extracorporeal circulation blood processing apparatus having a blood puncture needle that collects blood from a living body and returns blood to the living body, and includes an optical sensor that detects blood leakage from the puncture portion of the puncture needle. This problem can be solved by providing an extracorporeal circulating blood treatment apparatus characterized by the above.

  The puncture part of the extracorporeal blood circulation device has a blood return puncture part and a blood collection puncture part, but air will enter the blood circuit when the blood collection puncture needle is removed, so it is always checked whether there are bubbles in the blood circuit. Since monitoring is performed, it is not necessary to separately detect the withdrawal of the blood sampling puncture needle part, and the distance between the blood sampling puncture part and the blood return puncture part may vary depending on the facility, patient, etc. The monitoring by the optical sensor is preferably performed in the vicinity of the blood return puncture portion.

  The detection target of the optical sensor in the vicinity of the puncture portion of the blood return puncture needle of the present invention is, for example, the skin near the puncture portion of the blood return puncture needle, before the blood leaks from the member attached to the skin, and after the blood leaks Although the color may be mentioned, when the detection target is a member other than the skin, for example, a cloth attached to the skin, a white one is preferable so that the darkening of the detection member by blood can be more easily identified. Examples of the place where the optical sensor is attached include a patient's arm and blood circuit in the vicinity of the puncture portion of the puncture needle.

  The optical sensor continues to monitor the detection target before the blood adheres, for example, by using the reflection type optical sensor to emit light and irradiate light from the received light as a reference value, and the sensor receives light. If the reflectance is different as the reference value, it is determined that there is a blood leak. However, the optical sensor is not limited to the reflective optical sensor, and may be a transmissive optical sensor as long as it can detect blood leakage in the vicinity of the puncture portion of the blood return puncture needle. As the reference value, the transmittance before the blood adheres to the light emitted from the transmissive optical sensor is used as a reference value. If the transmittance is different from the reference value, it is determined that there is a blood leak.

A second aspect of the present invention is to detect blood leakage at a puncture site in extracorporeal circulation blood processing, wherein the optical sensor is fixed to an attachment member that can be attached to the arm, for example, a sticking member, a clip member, or a winding member The technical problem could be solved by providing an optical sensor to be used.
The optical sensor preferably has a structure that can be easily attached to and detached from the arm, and among them, a band-shaped member that has good blood bleeding and is elastic, for example, a ring-shaped winding fixing member such as a bandage or a watch band is most preferable . These optical sensors are usually constructed by extending an optical fiber part from the extracorporeal circulation blood apparatus, and transmit information about the color obtained by monitoring the puncture part of the puncture needle and its vicinity to the control part of the extracorporeal circulation blood treatment apparatus. Thus, the control unit can issue a blood leak alarm, or can issue an instruction to stop blood collection to the blood pump at the same time. In addition, when the optical sensor as described above is fixed to an attachment member that can be attached to the arm, for example, a sticking member, a clip member, or a winding member, information on the color obtained by the optical sensor is attached to these attachment members. It is also possible to arrange a processing member for information processing, and to transmit the processing result to the control unit of the extracorporeal circulation blood device by some transmission means.

  Examples of the winding type optical fiber sensor include an optical fiber sensor having a shape as shown in FIGS. Examples of the optical fiber sensor of the pasting method include a sensor having a shape as shown in FIG. Examples of the clip type optical fiber sensor include a sensor having a shape as shown in FIG. In these optical fiber sensors, when the distance between the puncture portion and the optical sensor changes, the reflectance changes only by that, so there is a possibility that a false alarm occurs when no blood leaks. Alternatively, since the clip member is fixedly attached to the arm, the distance in the vicinity of the puncture portion of the blood return puncture needle to be monitored by sensing with the optical sensor is always kept constant, so that the above false alarm may occur. Absent.

  In particular, the wrapping member shown in FIGS. 1 and 2 has a blood reservoir at the lower part of a band formed of a bandage that is a band-like member in which blood oozes well and is elastic. When a part of the band is drooped and blood leaks from the puncture portion of the blood return puncture needle, the leaked blood can be infiltrated into the blood reservoir from the drooping portion, and further, the blood reservoir Inside the unit, the optical sensor is arranged so as to be able to sense and monitor the hanging portion while maintaining a certain distance from the hanging portion, so that blood leakage can be quickly and accurately grasped from the puncture portion of the return puncture needle can do.

The detection of blood leakage by each of the optical sensors is performed, for example, by determining the absolute value of the received light amount as shown in FIG. 5 (light amount determination method) or by determining the change amount of the received light amount (edge determination method). Can do.
The light quantity discrimination method starts extracorporeal blood treatment and simultaneously starts sensing monitoring to detect blood leakage from the return puncture portion by irradiating the vicinity of the puncture portion of the return puncture needle with an optical sensor. If blood leakage occurs during blood processing, the monitoring location is gradually darkened by blood, and when the optical sensor is a reflective optical sensor, the amount of reflected light received by the optical sensor decreases gradually. When the amount of received light reaches the alarm value, it is determined that there is a blood leak, and an alarm is generated or the operation of the blood pump is stopped at the same time.

  In the edge determination method, it is determined whether or not blood leakage has occurred during the continuation of the extracorporeal blood treatment based on the slope of the graph of the light amount determination method. That is, in the case of an optical sensor, for example, a reflection type optical sensor, the graph value for edge discrimination is 0 (horizontal) as long as the amount of received light is a constant value. In this case, an inclination occurs, and the edge discrimination graph takes a certain value (a numerical value other than 0). In this case, it is determined that a blood leak has occurred.

  Comparing the light quantity discrimination method with the edge discrimination method, in the light quantity discrimination method, the reference value fluctuates due to dirt, scratches, etc., so an alarm is generated even if there is no blood leak. However, in the case of edge discrimination, the absolute value of the light intensity itself will be how much, but if the value is constant, the value is 0 in edge discrimination. Because it has a certain value (numerical value other than 0) only when the amount of light changes, there are few malfunctions due to dirt or scratches.

  The present invention provides an extracorporeal circulation blood processing apparatus and an optical sensor capable of quickly detecting blood leakage from a puncture portion of a puncture needle in extracorporeal circulation blood processing, particularly blood leakage from a return puncture portion. I was able to.

  Example of detection of blood leak from puncture part for return in hemodialysis treatment

  Hemodialysis that punctures blood and blood puncture needles for blood collection and return, and blood collected continuously from blood puncture needles is purified with a blood purifier and then returned from the puncture needle for blood return And a reflection type optical sensor that can receive light reflection data obtained by the sensor to the control unit of the hemodialyzer, for example, the control unit and an optical cable. Hemodialysis treatment was performed using a hemodialysis apparatus composed of a sensor of a fixed winding system shown in FIGS.

  The hemodialysis apparatus detects whether or not there is a blood leak from the return puncture part by the edge discrimination method in the control unit based on the light reflection received light data obtained by the sensor attached to the arm. I do. When a blood leak is determined, an alarm is issued by alarm means of the hemodialyzer.

It is explanatory drawing of the winding state of the winding member of the arm which has a winding member, a blood storage part, and an optical fiber sensor. It is explanatory drawing of the state before winding of the winding member of the arm which has a winding member, a blood storage part, and an optical fiber sensor. It is explanatory drawing of the sensor fixing tool of the optical sensor with which an arm is mounted | worn with a sticking form. It is explanatory drawing which fixed the optical sensor with the clip-type fixing tool. It is explanatory drawing of the light quantity discrimination method and the edge discrimination method.

Explanation of symbols

1 Band 2 Space part (arm insertion part)
DESCRIPTION OF SYMBOLS 3 Optical fiber 4 Box part 5 Optical sensor observation part 6 Optical sensor 7 Band attachment hole 8 Sensor fixture 9 Near puncture part 10 Skin 11 Fixing member

Claims (7)

An extracorporeal circulation blood processing apparatus having a blood return puncture needle that collects blood from a living body and returns blood to the living body, and senses the amount of reflected light received from the skin near the puncture portion of the puncture needle or a member attached to the skin And a blood leakage from the vicinity of the puncture portion of the puncture needle to the outside of the body based on the change in the amount of reflected light received as a sensing result of the reflection type photosensor. An extracorporeal circulating blood treatment apparatus characterized by the above. The extracorporeal circulation blood processing apparatus according to claim 1, wherein the detection of leakage of blood is determined (edge determination) based on a change amount of the amount of received light . The extracorporeal circulation blood processing apparatus according to claim 1 or 2, wherein the reflective optical sensor is an optical fiber sensor. The extracorporeal circulation blood processing apparatus according to any one of claims 1 to 3, wherein a reflective optical sensor is attached to the blood circuit portion. The extracorporeal circulation blood processing apparatus according to any one of claims 1 to 4, wherein the reflective optical sensor is fixed to a sticking member, a clip member, or a winding member that can be attached to the arm. 6. The extracorporeal circulation blood processing apparatus according to claim 5, wherein the winding member has a blood reservoir capable of infiltrating the leaked blood. The extracorporeal circulation blood processing apparatus according to claim 6, wherein the blood storage unit and the reflective optical sensor are maintained at a certain distance .

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