JP5511409B2 - Chemical injection system - Google Patents

Description

  The present invention relates to a chemical solution injection system that can determine not only the occurrence of extravasation but also what type of injection failure has occurred.

At present, CT (Computed Tomography) scanner, MRI (Magnetic Resonance Imaging) apparatus, PET (Positron) as medical diagnostic imaging equipment.
Emission Tomography) devices are known. When using such an imaging apparatus, a subject may be injected with a contrast medium, physiological saline, or the like (hereinafter, also simply referred to as “medical solution”).

In this chemical solution injection, the tip of the injection needle may come off the subject's blood vessel, and the contrast medium may be injected subcutaneously (referred to as “extravascular leakage”). For example, Patent Document 1 discloses a technique for detecting such extravasation.
The leak detection unit described in this document has a light emitting diode that irradiates a part of a subject's body with infrared light of a predetermined wavelength, and a phototransistor that receives the reflected light, and observes the intensity change of the reflected light Thus, the presence or absence of extravasation is determined.

WO2006 / 030764

By the way, as a mode of extravasation, there is a general leak type in which a contrast medium is accumulated near the puncture position of the injection needle (hereinafter referred to as “first type extravasation”), an elderly person, and the like. There is a type in which a contrast medium accumulates at a position away from the puncture position (hereinafter referred to as “second type extravascular leakage”).
As another injection failure, there may be a case where the connector of the tube is disconnected between the syringe and the subject, or a case where the injection needle is removed from the subject.

  As described above, there are several types of injection failures that can occur during the injection of a chemical solution. However, in the leak detection unit of Patent Document 1, basically, whether or not the first type extravascular leakage has occurred can be satisfactorily determined, but it is possible to determine whether or not another type of leak has occurred. Requires more careful observation by a physician or the like.

  By the way, when the above injection failure occurs, depending on the type, a doctor or the like performs an appropriate post-treatment on the subject, or is appropriate for an injection system (an injection head, a drug solution tube, etc.). You have to do something like this. In this regard, it is important to know what type of injection failure has occurred.

  The present invention has been made in view of the above problems, and its purpose is not only the presence or absence of extravasation but also a type of medicinal solution injection system that can determine what type of injection failure has occurred. Is to provide.

To achieve the above object, the chemical injection system of the present invention comprises:
A leak detection unit attached to the subject's body to detect the presence or absence of extravasation of the contrast agent;
A piston drive mechanism that slides the piston member of the syringe;
Pressure detection means (for example, pressure detection means for detecting the force by which the piston driving mechanism pushes the piston member) that directly or indirectly detects the pressure of the contrast medium during the injection operation;
An output means for audibly and / or visually presenting information to the operator;
A chemical injection system comprising:
From the combination of the detection result of the leak detection unit and the detection result of the pressure detection means, determine the type of injection failure,
The determination result is output to the output means.
The “pressure detection means for directly or indirectly detecting the contrast agent pressure” may be a load cell or indirectly from the magnitude of the motor current of the piston drive mechanism. May be detected.

  According to the present invention, since both the leakage detection unit and the pressure detection means are provided, and the type of injection failure determined based on the combination is indicated in the output means, an operator (doctor or the like) Can confirm what type of infusion failure has occurred, and as a result, physicians can take appropriate post-treatments to the subject, or to the infusion system (infusion head, drug tube, etc.) And perform appropriate operations.

  Examples of the “output means for visually and / or visually showing the information to the operator” may be a display, a lamp, a speaker, a buzzer, and the like.

  The present invention may also be as follows.

A detection value of the pressure detection means;
When none of the detection values of the leak detection unit is within the normal range,
It is determined that a first type extravasation has occurred.

As the leakage detection unit, it has a leakage detection unit attached near the puncture position of the injection needle, and one or more other leakage detection units attached at a position away from the vicinity of the puncture position,
The detection value of the pressure detection means is within a normal range,
When the detection value of the other leakage detection unit is not within the normal range,
It is determined that a second type of extravasation has occurred.

The detection value of the leak detection unit is within a normal range,
When the detection value of the pressure detection means is below the normal range,
It is determined that the connector of the tube is disconnected or the injection needle is disconnected.

  When it is determined that extravasation has occurred, an alarm is issued. Alternatively, the chemical solution injection operation is automatically stopped.

  The output means is a display, and the determination result is displayed on the display.

The leak detection unit is
A light emitting unit that emits light of a predetermined wavelength toward a part of the body of the subject;
And a light receiving portion that receives the reflected light.

  As described above, according to the present invention, it is possible to provide a chemical solution injection system that can determine not only the occurrence of extravasation but also what type of injection failure has occurred.

It is a figure which shows typically the chemical injection system of one form of this invention. It is sectional drawing which shows the structure of a leak detection unit. It is a figure for demonstrating operation | movement of the leak detection unit of FIG. It is a graph which shows the intensity | strength change of the reflected light when extravascular leakage generate | occur | produces, (a) shows a normal state, (b) shows the state which leaked. It is a figure for demonstrating the relationship between the combination of the detection result of a leak detection unit, the detection result of the said pressure detection means, and the type of injection | pouring defect. It is a figure showing the state where two leak detection units were attached to the upper and lower sides of a subject's arm. It is a figure about the other example of this invention.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
As shown in FIG. 1, the chemical injection system 1 of the present embodiment includes an injection head 10 that injects a chemical in a syringe 200 toward a subject, a display 50 that displays information such as chemical injection conditions, and the injection A control unit 30 that controls the operation of the head 10 and the like, and a leak detection unit 60 that is attached to the arm (one example) of the subject to detect the presence or absence of extravasation.

As the injection head 10, a conventionally known one can be used. As an example, the injection head 10 includes a syringe holding part (not shown) to which a syringe is attached, and a piston drive mechanism 15 that slides and moves a piston member of the syringe. Yes.
The injection head 10 may be a one-cylinder type to which only one syringe is attached, or a two-cylinder type to which two syringes (for example, contrast medium and physiological saline) are attached. There may be.

  The piston drive mechanism 15 has a motor (not shown) as a drive source and a drive rod 16 configured to move forward and backward and press the piston member of the syringe. The drive rod 16 is provided with a load cell 16a, which detects a pressure pushing the piston member.

The injection head 10 operates the piston drive mechanism 15 in response to a command from the control unit 30, whereby the chemical liquid is in a predetermined injection pattern (for example, the horizontal axis is time and the vertical axis is the injection speed). Extruded.
The control unit 30 may be incorporated in the injection head 10 or may be incorporated in a controller unit or the like separate from the injection head 10. Moreover, the piston drive mechanism may have an empty sensor for detecting the completion of the chemical liquid injection, for example, by detecting the slide position of the piston member.

The display 50 is not particularly limited as long as it can display predetermined information to the operator, and may be provided integrally with the injection head 10 or provided separately from the injection head 10. It may be done. A plurality of displays 50 may be provided.
Further, a touch panel display may be used so that the operator can perform an input operation through the screen. The injection system 1 may have a speaker for outputting information by voice in addition to the display 50.

As the leakage detection unit 60, a conventionally known one can be used. As an example, as shown in FIG. 2, the leakage detection unit 60 has a box-shaped housing 61 attached to a part of the subject's body. A phototransistor 63 is disposed downward.
The light beam from the light emitting diode 62 is irradiated to a part of the body of the subject through the opening 67a on the lower surface of the housing (see also FIG. 3). Then, the reflected light returns to the inside of the housing through another opening 67 b on the lower surface of the housing and is received by the phototransistor 63.

  As shown in FIG. 3, when extravasation occurs in the arm A of the subject and the contrast medium X is injected subcutaneously, the specific wavelength of the irradiated light is absorbed by the contrast medium X. As a result, as shown in FIG. 4B, the intensity of the specific wavelength in the reflected light is reduced as compared with the normal time (FIG. 4A). The presence or absence of extravasation can be determined by looking at the change in the reflection intensity.

In addition, regarding the use of the leakage detection unit 60, auto calibration (detailed below) may be performed. That is, it is preferable that the light amount of the light emitting diode 62 is automatically adjusted so that the detection value of the phototransistor 63 serving as the light receiving unit falls within a certain voltage range (XV ± a%).
Generally, the amount of light received by the phototransistor 63 (that is, the amount of reflected light) will show different values depending on the subject's skin color, constitution, etc. When the auto-calibration function is provided in this way, Since the amount of light received by the phototransistor 63 is constant, good detection can be performed regardless of the skin color and constitution of the subject and variations in elements. Note that this auto-calibration function is not limited to that used in the system 1 of FIG. 1, but can be used alone, since this function can obtain its own effects. May be.

Next, with reference to FIG. 5, the relationship between the detection result of the leak detection unit and the detection result of the pressure detection means and the corresponding extravasation type will be described.
5A to 5D show the detection result of the load cell and the detection result of the leak detection sensor during the chemical solution injection. As shown in FIG. 6, a leakage detection unit 60A is attached to the subject's arm in the vicinity of the puncture of the injection needle (upper side of the arm), and another leakage detection unit 60B is attached to the lower side of the arm. Yes. The graph as shown in FIG. 5 is displayed on the display 50 in real time during the injection of the chemical solution.

FIG. 5A shows that a general extravascular leakage, that is, a type of leakage in which a contrast medium is accumulated near the puncture position (first type extravascular leakage) has occurred.
In FIG. 5A, the detected value of the load cell is a constant value (within the normal range) until time t1, but rises after time t1 and is outside the normal range. In addition, the detection value of the leakage detection unit 60A also increases after time t1 and is outside the normal range (if the leakage occurs, the amount of light received decreases, so the graph will decrease, but the occurrence of an abnormality is not expected. (For clarity, the graph is displayed ascending.)

  Thus, in the case of a combination in which the detection result of the load cell 16a is abnormal and the detection result of the leakage detection unit 60A is also abnormal, it is determined as the first type extravascular leakage.

FIG. 5B shows that the “second type extravascular leakage” that may occur when the subject is an elderly person or the like occurs.
As shown in FIG. 6, this second type of extravascular leakage is a type in which the contrast medium from the needle tip accumulates not in the vicinity of the puncture position but in a site away from it (in this example, under the arm). Refers to the leakage of The reason why this type of leakage occurs is that, in the case of an elderly person, the contrast medium flows between the skin and the muscle, and the contrast medium may move to another site.

  In FIG. 5B, the detected value of the load cell is a constant value and within a normal range. On the other hand, the detection value of the leakage detection unit 60B rises after the time t1 and is outside the normal range. Thus, in the case of a combination in which the detection result of the load cell is normal but the detection result of the leakage detection unit 60B is abnormal, it is determined as the second type extravascular leakage.

  In this second type extravasation, the contrast medium does not always accumulate on the lower side of the arm. Therefore, more units may be used on the subject's arm in order to better detect this second type of extravasation. For example, a plurality of units may be arranged so as to surround the subject's arm.

Subsequently, in FIG. 5C, the detected value of the load cell suddenly drops at the time t1, and thereafter becomes a substantially constant value. The detection value of the leak detection unit is a constant value and within the normal range.
This combination indicates that the connector of the tube is disconnected and no chemical is injected into the body.
FIG. 5D shows a detection result of a type similar to that in FIG. 5C, but the amount of decrease in the detection value of the load cell is smaller than that in FIG. 5C. This combination indicates that the injection needle has been removed from the subject.

  Thus, in the chemical injection system 1 of the present embodiment, whether or not the first or second type extravascular leakage has occurred based on the combination of the detection result of the leakage detection unit and the detection result of the pressure detection means. Or whether or not the connector is disconnected. The determination result is displayed on the display 50. This process is performed by the function of the control unit 30.

Further, when it is determined that the first or second type extravascular leakage has occurred, or when it is determined that the connector of the tube is disconnected or the injection needle is removed, the display 50 and / or the speaker (not shown) ), A warning may be issued to a doctor or the like.
In this case, the driving of the piston drive mechanism 15 may be stopped, and the chemical liquid injection operation may be automatically stopped.

In the case of the second type extravascular leakage shown in FIG. 5B, the leakage detection unit 60A attached to the upper side of the arm may or may not detect an abnormality. This differs depending on whether or not a certain amount of contrast medium stays near the puncture position.
Further, only the detection results of the load cells are changed as shown in FIGS. 5A, 5C, and 5D, but the detection results of any of the leakage detection units 60A and 60B are not changed. In this case, it may be determined that another type of extravasation (leakage in which a contrast medium is accumulated at a position where no unit is present) has occurred.

  According to the chemical injection system of the present embodiment as described above, the system determines what type of injection failure has occurred based on the combination of the detection result of the leakage detection unit and the detection result of the pressure detection means. Since 1 is determined and displayed on the display 50, the doctor can confirm the type of injection failure. Therefore, an appropriate post-treatment can be performed on the subject (or on the system 1) according to the type of injection failure.

  Moreover, when such an injection failure occurs, an alarm is issued or the chemical solution injection is automatically stopped, so that adverse effects on the subject due to the injection failure can be suppressed.

As mentioned above, although one form of this invention was demonstrated, this invention can be variously changed besides the said form.
For example, as shown in FIG. 7A, the detection result of the load cell and the detection result of the leakage detection unit may be displayed in the same graph.
1 is provided, and the load cell detection result graph and the leak detection unit detection result graph as shown in FIG. 5 may be displayed on separate displays. Good.

  Moreover, as shown in FIG.7 (b), a TDC curve (Time Density Curve) may be displayed in those graphs. When extravasation occurs, the contrast agent is not sent to the imaging region, and as a result, the TDC curve does not draw the planned curve. If a TDC curve is displayed as shown in FIG. 7B, it is advantageous in that a doctor or the like can confirm the occurrence of extravasation by confirming the change in the curve.

  Moreover, regarding the leakage detection unit 60, a plurality of units are provided as shown in FIG. 6, and the type of defective injection is determined based on the combination of the detection results of the plurality of units 60 and the detection results of the load cell 16a. It may be done. Alternatively, only one unit 60A attached near the puncture position may be provided, and determination may be performed based on a combination of the detection result of the unit 60A and the detection result of the load cell 16a. Even with such a configuration, it is possible to determine the disconnection of the connector as shown in FIG.

[Detection that the unit itself is detached]
In this invention, the function which can detect that the leak detection unit removed from the test subject's body may be provided. As an example, the leakage detection unit used to realize this is not provided with a visible light filter in the opening on the lower surface of the housing, and thus can detect visible light entering the housing. .

When the leak detection unit is removed from the subject's body (or is likely to come off), visible light enters the housing from the opening on the lower surface of the housing. By detecting visible light, it can be determined that the unit itself has come off the subject's body. According to such a configuration, a failure at the time of injecting a chemical solution can be determined in more detail, so that a more reliable system is realized.
In addition to the above, a pressure-sensitive sensor can be used as a sensor for detecting that the unit itself is detached.

[Other changes]
In FIG. 1 and FIG. 6, the leakage detection unit 60 and the control unit 30 are depicted as being connected by wire. However, the connection is not limited to wired connection, and may be wirelessly connected.

1 Chemical Injection System 10 Injection Head 15 Piston Drive Mechanism 16a Load Cell 50 Display 60 Leakage Detection Unit 61 Housing 62 Light Emitting Diode 63 Photodiode 200 Syringe A Arm X Contrast Agent

Claims (16)

A leak detection unit attached to the subject's body to detect the presence or absence of extravasation of the contrast agent;
A piston drive mechanism that slides the piston member of the syringe;
Pressure detecting means for directly or indirectly detecting the pressure of the contrast agent during the injection operation;
An output means for audibly and / or visually presenting information to the operator;
A chemical injection system comprising:
From the combination of the detection result of the leak detection unit and the detection result of the pressure detection means, determine the type of injection failure,
The determination result is output to the output means. A detection value of the pressure detection means;
When none of the detection values of the leak detection unit is within the normal range,
The chemical solution injection system according to claim 1, wherein it is determined that a first type extravascular leakage has occurred. As the leakage detection unit, it has a leakage detection unit attached near the puncture position of the injection needle, and one or more other leakage detection units attached at a position away from the vicinity of the puncture position,
The detection value of the pressure detection means is within a normal range,
When the detection value of the other leakage detection unit is not within the normal range,
The chemical solution injection system according to claim 1, wherein it is determined that a second type extravascular leakage has occurred. The detection value of the leak detection unit is within a normal range,
When the detection value of the pressure detection means is below the normal range,
The chemical injection system according to claim 1, wherein it is determined that the connector of the tube is disconnected or the injection needle is disconnected.   The chemical solution injection system according to any one of claims 1 to 4, wherein an alarm is issued when it is determined that extravasation has occurred.   The chemical injection system according to any one of claims 1 to 5, wherein when it is determined that extravasation has occurred, the chemical injection operation is automatically stopped.   The chemical solution injection system according to any one of claims 2 to 4, wherein the output means is a display, and the result of the determination is displayed on the display. The leak detection unit is
A light emitting unit that emits light of a predetermined wavelength toward a part of the body of the subject;
The chemical injection system according to claim 1, further comprising a light receiving unit that receives the reflected light. The medicinal-solution injection system according to claim 1, wherein the detection value of the pressure detection means is not within a normal range and the detection value of the leakage detection unit is within a normal range. The medicinal-solution injection system according to claim 1, wherein a state in which the detection value of the pressure detection means is within a normal range and the detection value of the leakage detection unit is also within a normal range is detected. The said output means is a display, and the detection result of the said pressure detection means and the detection result of a leak detection unit are displayed on the same graph on this display. Chemical injection system. Furthermore, the chemical | medical solution injection system of Claim 11 with which the time density curve (Time Density Curve: TDC) which a horizontal axis shows time and a vertical axis | shaft shows a contrast agent density | concentration is also displayed in the said graph. When the detection value of the leak detection unit is within the normal range, the time density curve (Time Density Curve: TDC) in which the horizontal axis indicates time and the vertical axis indicates the contrast agent concentration does not rise as planned. The medicinal-solution injection system according to any one of claims 1 to 12, which determines that there is a possibility that two types of extravasation have occurred. The chemical injection system according to claim 1, wherein the pressure detection unit uses a load cell. The chemical solution injection system according to claim 1, wherein the pressure detection means uses a motor current of a motor of the piston drive mechanism. A piston drive mechanism for sliding the piston member of the syringe, and an injection head having pressure detection means for directly or indirectly detecting the pressure of the contrast medium during the injection operation;
A control unit for controlling the operation of the injection head;
A leak detection unit attached to the subject's body to detect the presence or absence of extravasation of the contrast agent;
An output means for audibly and / or visually presenting information to the operator;
A chemical injection system comprising:
The control unit determines the type of injection failure from the combination of the detection result of the leak detection unit and the detection result of the pressure detection means,
The determination result is output to the output means.

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