WO2011087059A1 - Leakage detection unit and leakage detection system - Google Patents

Abstract

Disclosed are a leakage detection unit which can detect the occurrence of extravasation with increased accuracy, and a system equipped with the leakage detection unit. The leakage detection unit (60) is provided with: a plurality of sensor units (61A-61C), each of which has a light emission element which irradiates a predetermined wavelength of light on a part of the body of a test subject, and a light reception element which receives the reflected light; and a support body (63) which supports the plurality of sensors. The plurality of sensor units (61A-61C) are disposed on the support body (63) so as to be located around an injection needle tip (P1) when viewed from above. The location on the support body (63) at the top of the tip (P1) is hollow, enabling palpation.

Description

Leak detection unit and leak detection system

The present invention relates to a technique for detecting extravasation when a medical solution is being injected into a subject. In particular, the present invention relates to a leak detection unit capable of detecting extravasation with higher accuracy and a system including the leak detection unit.

Currently, there are CT (Computed Tomography) scanners, MRI (Magnetic Resonance Imaging) devices, PET (Positron Emission Tomography) devices, ultrasound diagnostic devices, etc. as medical devices for imaging tomographic images of subjects. Examples of medical devices for imaging include an angio device and an MRA (MR ANGIO) device.

When using the medical device as described above, a medical solution such as a contrast medium or physiological saline may be injected into the subject. A chemical injection device that automatically executes this injection has also been put into practical use.
In this injection device, for example, a chemical syringe in which a piston member is slidably inserted into a cylinder member is loaded, and a piston driving mechanism pushes the piston member of the syringe. Thereby, the chemical | medical solution in a syringe is inject | poured into a subject via a tube.

In such a chemical solution injection, when the chemical solution is injected, the injection needle may come off from the blood vessel for some reason, and the chemical solution may leak subcutaneously (referred to as “extravascular leakage”). Conventionally, as a technique for detecting such extravasation, for example, there is a technique described in Patent Document 1.
The leak detection unit described in this document has a light emitting element that emits light of a predetermined wavelength toward a part of the body and a light receiving element that receives the reflected light.

WO2006 / 030764

By the way, extravasation generally occurs in the vicinity of the tip of the injection needle inserted into the body of the subject. Therefore, conventionally, the leakage detection unit has been used by being attached to a position that covers the tip of the injection needle. When extravasation occurs, the skin swells at that position, but it has been difficult to confirm the occurrence of leakage by palpation with the conventional unit. This is because the leak occurrence position is covered by the unit, and the portion cannot be palpated.

On the other hand, for example, when a drug solution leaks along a blood vessel or muscle, extravasation occurs at a location slightly away from the tip of the injection needle. It is desired to develop an apparatus that can detect such extravasation well.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a leakage detection unit capable of detecting the occurrence of extravascular leakage with higher accuracy and a system including the leakage detection unit.

In order to achieve the above object, the leak detection unit of the present invention comprises:
A plurality of sensor units, each sensor unit having a light emitting element that emits light of a wavelength toward a part of the body of the subject and a light receiving element that receives the reflected light When,
A support that supports the plurality of sensor units;
A leakage detection unit for detecting extravasation at the tip of the injection needle,
When the leakage detection unit is viewed from above, a plurality of the sensor parts are arranged so as to surround the tip of the injection needle, and
The support is characterized in that a portion above the tip of the injection needle is cut out.

“Arranged so as to surround” includes a configuration in which one sensor portion is disposed on each side of the tip of the injection needle.
The term “cut out” is not intended to limit the manufacturing method of the support in any way and is intended to be an opening or a recess.

According to the present invention, since a plurality of sensor units are arranged so as to surround the tip of the injection needle, the occurrence of leakage is detected in a wider range as compared with the conventional configuration in which detection is performed by one sensor unit. be able to. Moreover, since the portion above the tip of the injection needle is cut out with respect to the support body, the doctor can perform direct contact diagnosis of the subject's body and can confirm the occurrence of leakage by palpation.

The leak detection system of the present invention includes the leak detection unit and a control unit that controls the operation of the leak detection unit.

As described above, according to the present invention, it is possible to provide a leak detection unit capable of detecting the occurrence of extravasation with higher accuracy and a system including the leak detection unit.

It is a mimetic diagram of an injection system in which a leak detection system of one form of the present invention was used. It is a top view of the leak detection unit of FIG. FIG. 3 is a cross-sectional view taken along line AA of the unit of FIG. FIG. 3 is a cross-sectional view taken along line BB of the unit of FIG. It is a top view which shows the other example of a leak detection unit. It is a schematic diagram which shows the other example of a sensor part. It is a top view which shows the other structural example of this invention. It is a top view which shows the other structural example of this invention. The other example of the leak detection unit is shown, (a) is a longitudinal cross-sectional view, (b) is a bottom view.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
The medicinal solution injection system 1 shown in FIG. 1 includes an injection head 10 for injecting a medicinal solution in a syringe 200 toward a subject, a display 50 on which various information is displayed, and a subject's in order to detect the occurrence of extravasation. A leakage detection unit 60 attached to the arm 100 (one example) and a control unit 30 that controls the operation of the head 10 and the unit 60 are provided.

A conventionally known injection head 10 can be used. As an example, the head 10 includes a syringe holding unit (not shown) on which a syringe is mounted, and a piston drive mechanism 15 that slides a piston member of the syringe. 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 configured to move forward and backward to press the piston member of the syringe. The injection head 10 operates the piston drive mechanism 15 in response to a command from the control unit 30. Thereby, the chemical solution is pushed out in a predetermined injection pattern (for example, a pattern in which the horizontal axis is time and the vertical axis is the injection speed).

The control unit 30 may be incorporated in the injection head 10 or may be provided separately 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 information to the operator. The display 50 may be provided integrally with the injection head 10 or may be provided separately from the injection head 10.

Further, this display may be a touch panel display so that the operator can perform an input operation through the screen. In addition to the display 50, the system 1 may have a speaker for outputting information by voice.

In addition, the “leakage detection unit” in this specification corresponds to the leak detection unit 60 in the example of FIG. “Leakage detection system” corresponds to a part of the functions of the leak detection unit 60 and the control unit 30.

As shown in FIG. 2, the leakage detection unit 60 includes a plurality of sensor units 61 </ b> A, 61 </ b> B, 61 </ b> C (hereinafter also simply referred to as “sensor unit 61”) and a support sheet 63 that supports the sensor unit 61. ing. The support sheet 63 has flexibility to cope with the curvature of the human body.

The support sheet 63 is U-shaped as a whole, and has a shape in which a portion of the leakage occurrence position P1 that the leakage detection unit 60 is to detect is cut out. The three sensor parts 61A, 61B, 61C are arranged so as to surround the leakage occurrence position P1. In this example, the leakage occurrence position P1 is located at the tip of the injection needle 201.

A cord 67 extends from the edge of the support sheet 63, and the cord 67 is connected to the control unit 30 described above. An adhesive tape (one example) is provided on the back surface of the support sheet 63, whereby the support sheet 63 can be attached to the body of the subject. Note that the communication is not limited to the code 67 but may be performed by a wireless method.

FIG. 3 is a cross-sectional view taken along the line AA in FIG. 2 and schematically shows the configuration of the sensor unit 61. As shown in FIG. 3, the sensor unit 61 has a light emitting element 65 that emits light of a predetermined wavelength toward a part of the body of the subject, and a light receiving element 66 that receives the reflected light. The light emitting element 65 may be a light emitting diode. The light receiving element 66 may be a phototransistor.

The light from the light emitting element 65 is irradiated onto a part of the subject's body, and the reflected light is received by the light receiving element (for example, the phototransistor 66). When extravasation occurs in the subject's arm and the contrast medium is injected subcutaneously, the specific wavelength of the irradiated light is absorbed by the contrast medium. As a result, the intensity of the specific wavelength of the reflected light is reduced as compared with the normal time. The presence or absence of extravasation can be determined by looking at the change in the reflection intensity.

FIG. 4 is a cross-sectional view taken along the line BB in FIG. 2 and schematically shows the arrangement of the sensor unit 61. As shown in this figure, in the present embodiment, the light emitting elements 65 of the sensor unit are arranged obliquely so that the emission direction thereof faces the leakage occurrence position P1. Note that “disposed obliquely” means that the sensor unit is inclined with respect to the normal direction of the support sheet 63.

According to such a configuration, as shown in FIG. 4, the sensor unit 61 is not disposed immediately above the leakage occurrence position P1, but the occurrence of leakage can be detected well. All of the three sensor units 61A to 61C may have such an inclined arrangement, or only a part thereof may have such an arrangement. Of the light emitting element and the light receiving element, only the light emitting element may be inclined, or both the light emitting element and the light receiving element may be inclined.

Although FIG. 4 shows a configuration in which the light emitting element itself is slanted, this is merely an example, and other configurations may be used. For example, an element configured to emit light in an oblique direction by changing the shape of the light guide member of the light emitting element may be used.

According to the leak detection unit 60 of the present embodiment as described above, the plurality of sensor units 61A to 61C are arranged so as to surround the leak occurrence position P1. Therefore, it is possible to detect the occurrence of leakage in a wider range as compared with the conventional configuration in which detection is performed by one sensor unit.

Further, the support sheet 63 in the portion above the leakage occurrence position P1 is cut out, and the doctor can visually or palpate the body surface of the subject in this portion. Therefore, the presence or absence of leakage detection can also be confirmed by palpation or the like. Furthermore, when the support sheet 63 is cut out as described above, there is an advantage that positioning is easy when the unit is attached to the body of the subject.

In addition, this invention is not limited to the said form, A various change is possible. For example, in the example of FIG. 2, only two sensor units 61 or four or more sensor units 61 may be provided.

As shown in FIG. 5, a support sheet 163 that is not U-shaped may be used. The support sheet 163 is rectangular as an example, and one opening is provided in the center. Even if it is such a shape, the effect by hollowing out the part above the leak occurrence position can be obtained similarly to the above embodiment. In the example of FIG. 5, four sensor portions 161 are provided in the vicinity of each corner portion of the support sheet 163.

As shown to Fig.6 (a), the directivity of the light emitting element 65 of one sensor part (for example, sensor part 61A) differs from the directivity of the light emitting element 65 of another sensor part (for example, sensor part 61B). It may be. According to such a configuration, detection with higher accuracy is possible. This is because, even if the extravasation cannot be detected by one sensor unit, the extravasation can be detected by another sensor unit having different directivity.

As shown in FIG. 6B, the wavelength of the light emitting element 65 of one sensor unit may be different from the wavelength of the light emitting element 65 of another sensor unit. Even with such a configuration, detection with higher accuracy is possible. This is because even if extravasation cannot be detected by one sensor unit, the extravasation can be detected by another sensor unit having a different wavelength.

As an example, the detection depth may be changed by changing the current value applied to the light emitting element of the sensor unit. Such a method is advantageous in that it is not necessary to separately provide sensor units 61 having different structures and characteristics. This is because even if the light emitting elements of the sensor units are the same, the detection characteristics can be changed by simply changing the current value.

Further, as shown in FIGS. 7 and 8, a plurality of leakage detection units 260 may be provided. In the example of FIG. 7, the three leak detection units 260 are arranged in a triangular shape so as to surround the leak occurrence position p1. The units are connected by a wiring 261, and a cord 267 is connected to one of the three units.

In the example of FIG. 8, the four leak detection units 260 are arranged in a square shape so as to surround the leak occurrence position p1. The units are connected by a wiring 261, and a cord 267 is connected to one of the four units.

Naturally, in the configuration example of FIGS. 7 and 8, the unit as shown in FIG. 2 or the unit as shown in FIG. 5 may be used instead of the leak detection unit 260 shown in the figure. In addition, the communication is not limited to the code 267 but may be performed by a wireless method.

(Operation timing of sensor unit)
When a plurality of sensor units are provided as described above, a configuration in which detection by each of the sensor units 61A to 61B (an example) is performed simultaneously may be employed. That is, a configuration may be adopted in which all the sensor units 61A to 61C operate to monitor the occurrence of extravascular leakage during the injection of a chemical solution into a subject. Such an operation method can be preferably applied, for example, when the detection ranges of the sensor units do not overlap each other. This is because when the detection ranges of the sensor units do not overlap each other, it is not necessary to consider the influence of mutual interference between the sensor units.

Apart from the above, the detection by each of the sensor units 61A to 61C may be performed in a predetermined order. Such an operation can be preferably applied when the detection ranges of the sensor units overlap each other, thereby preventing erroneous detection due to interference.

As the “predetermined order”, there are a method in which the sensor units 61A to 61C are operated in order, a method in which the sensor units 61B, 61A, 61B, and 61C are operated in order (an example), for example. Further, after the detection by a certain sensor unit is completed, the detection by the subsequent sensor unit may be started after a certain period of time. In addition, the sensor units are not limited to operate one by one, but a plurality of sensor units (61A to 61C in the example of FIG. 2) are divided into two or more groups (for example, 61A and 61C pairs and 61B). The detection by the group may be performed in a predetermined order.

Generally, extravasation often occurs near the tip of the injection needle, and in order to detect this extravasation well, it is preferable that the distance between each sensor unit 61 and the position P1 is short. However, in the configuration including the plurality of sensor units 61A to 61C as in the present embodiment, if the distance is reduced, the distance between the sensor units is also reduced, and erroneous detection due to mutual interference is likely to occur. In this regard, as described above, if detection by each of the sensor units 61A to 61C is performed in a predetermined order, good detection can be performed while preventing erroneous detection due to mutual interference.

In the present invention, when it is determined that extravascular leakage has occurred during the injection of a chemical solution, a warning may be issued through the display 50 or a speaker (not shown), for example. Or the injection | pouring operation | movement of a chemical | medical solution may be stopped automatically.

(Mode to adjust directivity by opening shape)
FIG. 9 is a diagram for explaining an example in which the directivity of the leakage detection unit is adjusted by changing the size of the opening of the housing of the unit.
The leakage detection unit 360 includes a flat circular housing 361, and a light emitting element (light emitting diode) 365 and a light receiving element 366 that are provided downward on a substrate disposed therein.

On the bottom surface of the housing 361, an opening 368a is formed at a position facing the light emitting element 365, and an opening 368b is formed at a position facing the light receiving element 366. Light from the light emitting element 365 is emitted toward the body of the subject through the opening 368a. The reflected light is received by the light receiving element 366 through the opening 368b.

The distance d1 from the light emitting diode chip to the housing opening 368a is, for example, 1.2 mm to 1.5 mm (more specifically 1.3 mm). As shown in FIG. 9B, the distance between the centers of the openings 368a and 368b is, for example, 5.2 mm.

Opening 368a is a square, the longitudinal dimension _{d 2a} is 2.0 mm, the lateral dimension _{d 2b} is 2.0 mm. The opening _368b is rectangular and has a vertical dimension _d3a of 2.0 mm and a horizontal dimension _d3b of 3.0 mm. The lateral dimension d _2b of the opening 368a may be 1.0 mm to 3.0 mm, preferably 1.5 mm to 2.5 mm. Lateral dimension _d3b of the opening 368b is preferably greater than the transverse dimension _{d 2b} of the opening portion 368a.

In the unit as shown in FIG. 9, the directivity of light emitted to the outside of the housing can be adjusted by appropriately changing the size of the opening 368a on the light emitting element 365 side. Specifically, the light emitted to the outside can be narrowed by making the size of the opening 368a relatively small (the emission angle θ in FIG. 9A). By narrowing the emission angle θ in this way, the influence of the reflected light on the skin surface is reduced, and as a result, the detection accuracy of the entire unit can be improved.

Regarding the opening 368b on the light receiving element side, when the opening is enlarged, the amount of received light increases, but the influence of noise due to the surface condition of the human body also increases, so when determining the size of the opening, It is preferable to determine appropriately considering the influence and the like.

DESCRIPTION OF SYMBOLS 1 Chemical injection system 10 Injection head 15 Piston drive mechanism 50 Display 60, 160, 260, 360 Leak detection unit 61 Sensor part 63 Support sheet 65, 365 Light emitting element 66, 366 Light receiving element 67 Code 200 Syringe 201 Injection needle 368a, 368b Opening Part P1 Leakage detection position

Claims (9)

A plurality of sensor units, each sensor unit having a light emitting element that emits light of a wavelength toward a part of the body of the subject and a light receiving element that receives the reflected light When,
A support that supports the plurality of sensor units;
A leak detection unit for detecting extravasation near the tip of the injection needle,
When the unit is viewed from above, a plurality of the sensor parts are arranged so as to surround the injection needle tip, and
The leakage detection unit according to claim 1, wherein a portion of the support above the tip of the injection needle is cut out. The leakage detection unit according to claim 1, wherein the support has a shape in which an opening is formed in a central portion thereof or a U shape. In at least one of the sensor units,
The leak detection unit according to claim 1 or 2, wherein the light emitting elements are arranged obliquely so that the emission direction of the light emitting elements faces the distal end side of the injection needle. The leakage detection unit according to any one of claims 1 to 3, wherein the directivity of one of the sensor units is different from the directivity of the other sensor unit. The leak detection unit according to any one of claims 1 to 4, wherein a wavelength of one of the sensor units is different from a wavelength of the other sensor unit. The leakage detection unit according to any one of claims 1 to 5,
A leakage detection system comprising: a control unit that controls the operation of the leakage detection unit. The leakage detection system according to claim 6, wherein detection by each sensor unit is performed simultaneously. The leakage detection system according to claim 6, wherein detection by each sensor unit is performed in an order. The leakage detection system according to claim 6, wherein the plurality of sensor units are divided into two or more groups, and detection is performed in an order in which each group is detected.

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