JP2006110119A - Puncture monitoring device - Google Patents

Abstract

【Task】
There is provided a monitoring device for a puncture unit that can predict the puncture needle dropout and reliably avoid the adverse effects of the puncture needle dropout.
[Solution]
A puncture needle 1 that can puncture a patient, and a flexible tube 2 that extends from the puncture needle 1 and that can introduce liquid into the patient's body or lead blood out of the patient's body through the puncture needle 1 In the puncture monitoring apparatus comprising the electrode section 4, which is formed at a fixed portion of the puncture needle 1 or the flexible tube 2 fixed to the patient during treatment and detects that the fixed portion is separated from the patient. And a warning means 6 for giving a warning when it is detected by the electrode part 4 that the fixed part is separated from the patient.
[Selection] Figure 1

Description

  The present invention relates to a monitoring device for a puncture unit in which a flexible tube is extended from a puncture needle such as a blood circuit.

  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.

  By the way, during dialysis treatment, when the arterial puncture needle that has punctured the patient comes off for some reason or is disconnected from the flexible tube forming the arterial blood circuit, air is sucked from the arterial puncture needle. The patient's blood introduced from the arterial side puncture needle when an air lock occurs in the device or when the venous side puncture needle comes off for some reason or is disconnected from the flexible tube forming the venous side blood circuit. Therefore, various proposals have been made in order to detect such puncture needles being removed from the patient or disconnected from the blood circuit.

For example, as disclosed in Patent Document 1, a foil electrode is sandwiched between a synthetic resin tape, a non-woven tape, and an adhesive material layer, and a patient's arm with a puncture needle punctured by the adhesive material layer There has been proposed a leak detection device for adhering to a liquid. As a result, when the puncture needle comes out of the patient and leakage of blood, medicine, or the like occurs, the leaked liquid can short-circuit the foil electrode and detect the leakage.
Japanese Utility Model Publication No. 5-79468

  However, the conventional monitoring device (leakage detection device) for the puncture unit detects that a liquid such as blood has leaked from the puncture needle, and cannot predict the puncture needle from being removed. The above-mentioned adverse effects due to the puncture needle coming out of the device could not be surely avoided. In other words, the above-mentioned conventional device can be detected only after the puncture needle has been removed from the patient, and therefore it is unavoidable that a slight liquid leakage occurs.

  In particular, in a puncture needle (such as a venous side puncture needle of a blood circuit) for injecting blood or a drug into a patient's body, the flow resistance of the puncture needle that has been left remains generated, so the puncture needle that has left the patient. It is possible that the blood will flow around and blood, medicine, etc. will scatter around and will not necessarily drop on the leak detection device. Therefore, there has been a problem that the removal of the puncture needle cannot be detected with high accuracy.

  The present invention has been made in view of such circumstances, and it is an object of the present invention to provide a monitoring device for a puncture unit that can predict the puncture needle from falling out and can reliably avoid the adverse effects of the puncture needle being removed. .

  According to the first aspect of the present invention, a puncture needle capable of puncturing a patient, and extending from the puncture needle, can introduce liquid into the patient's body or lead blood from the patient's body via the puncture needle. In a puncture monitoring apparatus comprising a flexible tube, a puncture needle or a flexible tube is formed at a fixed site fixed to a patient during treatment, and detects that the fixed site is separated from the patient. It is characterized by comprising detection means and signal generation means for generating a signal when the detection means detects that the fixed part is separated from the patient.

  According to a second aspect of the present invention, in the monitoring device for a puncture unit according to the first aspect, a plurality of the detection means are provided with respect to the fixed part, and the detection means are in accordance with the distance from the puncture needle. The alarm level by the signal generating means is changed.

  According to a third aspect of the present invention, in the puncture monitoring apparatus according to the first or second aspect, the detection means comprises a touch sensor that electrically detects a state separated from a state in contact with the patient. Features.

  According to a fourth aspect of the present invention, in the puncture monitoring apparatus according to any one of the first to third aspects, the puncture needle is composed of a winged needle having a wing at its root, and The detection means is provided on the contact surface of the wing with the patient.

  According to a fifth aspect of the present invention, in the puncture monitoring apparatus according to any one of the first to third aspects, the detection means is a patient in a bandage for fixing the flexible tube to the patient. It is provided in the contact surface.

  According to a sixth aspect of the present invention, in the puncture monitoring apparatus according to any one of the first to third aspects, the detection means is provided integrally with an outer surface of the flexible tube. It is characterized by.

  According to the invention of claim 1, during the treatment, it can be detected by the detection means that the fixed site is separated from the patient, and a signal can be generated by the signal generation means, so that the puncture needle can be predicted to be removed, It is possible to reliably avoid the adverse effects caused by the removal of the puncture needle.

  According to the invention of claim 2, since a plurality of detection means are provided for the fixed part and the alarm level by the signal generation means is changed in accordance with the distance between each detection means and the puncture needle, It is possible to differentiate the degree of risk in predicting.

  According to the invention of claim 3, since the detection means is composed of a touch sensor that electrically detects a state separated from the state in contact with the patient, the detection means can be formed by forming, for example, an electrode at the fixed portion. The detection means can be made thinner.

  According to the invention of claim 4, the puncture needle is composed of a winged needle having a wing at its base, and the detection means is provided on the contact surface of the wing with the patient, so that it is very close to the access blood vessel. The position of the puncture needle can be predicted at the position, and a more reliable alarm can be issued.

  According to the invention of claim 5, since the detecting means is provided on the contact surface with the patient in the adhesive bandage for fixing the flexible tube to the patient, the medical staff or the like can detect the fixing means at an arbitrary position. Can be provided.

  According to the sixth aspect of the present invention, since the detection means is provided integrally with the outer surface of the flexible tube, the detection means can be arranged at the fixed part without making the patient, medical staff, etc. aware of it. it can.

Hereinafter, embodiments of the present invention will be specifically described with reference to the drawings.
The monitoring device for the puncture unit according to the first embodiment includes a blood circuit composed of a flexible tube used in dialysis treatment and a puncture needle attached to the distal end of the flexible tube used during blood transfusion or infusion. As shown in FIGS. 1 and 2, the puncture needle 1, the flexible tube 2, the wing 3, the electrode part 4 constituting the detection means, and the determination part 5 can be predicted. And alarm means 6 as signal generating means.

  The puncture needle 1 can puncture a patient to circulate the patient's blood extracorporeally or introduce blood or medicine into the patient's body, and forms a winged needle formed integrally with the wing 3. . The wing 3 is fixed to the patient to prevent the puncture needle 1 from rotating while being punctured by the patient. For example, as shown in the figure, the plate-like portion extends in two directions. It consists of a resin member. In normal treatment, a bandage or the like is applied across the wing 3 and the patient's skin, but this is omitted in FIG.

  The flexible tube 2 is connected to and extends from the proximal end side of the puncture needle 1 and can introduce liquid into the patient's body or lead blood from the patient's body through the puncture needle 1. For example, when applied to a blood circuit used in dialysis treatment, the other end is connected to a blood purification means such as a dialyzer, and when applied to a puncture monitoring device used for infusion or blood transfusion, an infusion bag Alternatively, the other end side is connected to a blood transfusion bag or the like.

  The electrode unit 4 constitutes a so-called touch sensor. As shown in FIG. 2, the electrode unit 4 is formed on the back surface 3a (contact surface with the patient) of the wing 3 (for example, a conductive material is coated by vapor deposition or the like to form a predetermined pattern. This is to form a so-called touch sensor that is formed by printing the sheet, and to electrically detect a state in which the back surface 3a of the wing 3 is separated from the state in contact with the patient.

  Specifically, the electrode unit 4 forms a switch that is turned on (formation of a predetermined closed circuit, etc.) while touching the patient and is turned off (breaking of the predetermined closed circuit, etc.) when separated from the patient. From this, it is configured to detect that the back surface 3a of the wing 3 is separated from the patient. In addition, the back surface 3a (contact surface with a patient) of the wing | blade 3 comprises the "fixed site | part fixed to the patient of the puncture needle 1" in this invention.

  Here, various types of touch sensors have been provided, but in the present embodiment, it is preferable to use a hum induction type touch sensor, a capacitance type touch sensor or the like. The hum induction type touch sensor is a sensor that inputs an induced voltage to the electrode unit 4 using a commercial power source (electrostatic induction) induced by the human body. When the human body touches the electrode unit 4, the human body is used as an antenna. The presence or absence of the induced voltage of the commercial AC power generated in the electrode unit 4 is used as a switch.

  In addition, the capacitive touch sensor brings the human body into contact with the electrode unit 4 to which an alternating voltage is applied, and the transmission circuit, the electrode unit 4, the patient's skin and human body, the ground (floor surface), the electrostatic capacity of the human body, Making a loop of the transmission circuit, detecting the leakage current value to the patient and detecting whether the human body and the electrode unit 4 are touching, using the electrode unit 4 as part of the LC or RC transmission circuit, Detecting whether or not the human body and the electrode unit 4 are in contact with each other by the transmission frequency that changes due to the contact or approach of the human body to the electrode unit 4, the electrode unit 4 is used as a part of the LC resonance circuit, and the electrode unit 4 Detecting whether or not the human body and the electrode unit 4 are in contact with each other by the resonance frequency that changes due to contact or approach of the human body, or a clock is input to the electrode unit 4 and the human body contacts the electrode unit 4 Rise waveform delay (waveform Be any of those by observing the Mari) detects whether a human body and the electrode portion 4 is touching.

  In addition to the touch sensor described above, for example, a pyroelectric sensor or a piezoelectric element may be used. The pyroelectric sensor detects the infrared rays (about 10 μm) emitted from the human body by using a pyroelectric element (sensor having sensitivity in a wavelength range of 7 to 20 μm), and touches the human body and the electrode unit 4. In the case of using a piezoelectric element, an electromotive force generated by pressing the piezoelectric element is detected to detect whether the human body and the electrode unit 4 are in contact with each other. Is for.

  A wiring H1 extends from the electrode portion 4, and a determination portion 5 is connected to the tip thereof. The determination unit 5 includes, for example, a unit placed in the vicinity of a bed on which a patient is seated or lying, and can electrically process a signal from the electrode unit 4. As shown in FIG. 3, the determination unit 5 includes a signal detection unit 7, a signal amplification unit 8, a contact determination unit 9, a transmission unit 10, and an alarm unit 11.

  Thereby, the electrical change of the electrode part 4 is transmitted to the signal detection means 7, and after the electric signal is amplified by the signal amplification means 8, whether or not the electrode part 4 is separated from the patient by the contact determination means 9. Can be determined. When it is determined by the contact determination means 9 that the electrode unit 4 is separated from the patient, the alarm means 11 in the determination part 5 causes a predetermined alarm to be issued, and the transmission means 10 externally (for example, medical) The alarm means 6 in a place other than the room where the treatment is performed such as the waiting room or the central control room of the worker) is caused to give an alarm.

  The alarm means 11 and the alarm means 6 are for alarming when the back surface 3a (fixed part) of the wing 3 is separated from the patient by the electrode unit 4, for example, by a predetermined sound or sound by a speaker or the like. Various forms may be used as long as they can alert a medical worker, such as those that can issue warnings, those that can display predetermined characters or marks on a monitor, etc., or those that emit a lamp or the like. . That is, the alarm unit 11 or the alarm unit 6 is sufficient if it generates a signal when it is detected that the fixed portion is separated from the patient by the electrode unit 4 constituting the detection unit.

  According to the above embodiment, since the electrode portion 4 is formed on the contact surface (back surface 3a) of the wing 3 with the patient, the following operational effects are obtained. That is, when the puncture needle 1 is withdrawn from the patient during the treatment, the wing 3 is usually separated from the patient prior to the withdrawal of the needle, so that the electrode unit 4 detects and determines the separation of the wing 3 from the patient. By causing the alarm means 11 of the unit 5 or the external alarm means 6 to issue an alarm, the puncture needle 1 can be predicted to be removed and avoided beforehand. In addition, since the electrode portion 4 is formed on the wing 3, the puncture needle 1 can be predicted to come off at a position very close to the access blood vessel, and a more reliable alarm can be performed.

Next, a puncture monitoring apparatus according to a second embodiment of the present invention will be described.
As in the first embodiment, the monitoring device for the puncture unit according to the second embodiment is a blood circuit composed of a flexible tube used in dialysis treatment or a flexible tube used during blood transfusion or infusion. The puncture needle attached to the tip can be predicted to come off from the patient. As shown in FIGS. 4 and 5, the puncture needle 1, the flexible tube 2, the wing 3, the electrode unit 4, It is mainly comprised from the determination part 5, the alarm means 6, and the clamping member 12. FIG. In addition, the same code | symbol shall be attached | subjected about the component similar to previous embodiment, and those detailed description shall be abbreviate | omitted.

  The clamping member 12 is made of a resin member that can be disposed at a fixed portion of the flexible tube 2 that is fixed to the patient. As shown in FIG. 5, the insertion member 12a that penetrates in the longitudinal direction, and the longitudinal direction As in the first embodiment, the electrode portion 4 made of a touch sensor is formed on the flat surface 12c. And the fixed part of the flexible tube 2 is contact | abutted along the notch 12b, and the said flexible tube 2 fits in the penetration hole 12a by pushing in as it is.

  In this state, the puncture needle 1 is punctured into the patient, and the flat surface 12c of the holding member 12 is fixed to the patient's skin while being fixed with the adhesive bandage B or the like, and a predetermined treatment is performed (the blood from the puncture needle is circulated extracorporeally) Clean up, transfuse, instill, etc.). During the treatment, when the clamping member 12 is separated from the patient, the electrode unit 4 detects this, and the alarm unit 11 of the determination unit 5 or an external alarm unit 6 gives an alarm to predict the puncture needle 1 coming off. Can be avoided.

  According to the present embodiment, since the electrode member 4 is provided on the holding member 12 and the holding member 12 is fitted into the fixing portion of the flexible tube 2, the medical worker can fix the flexible tube 2. The electrode unit 4 can be set at any position. Moreover, the clamping member 12 can be used several times, and it can also contribute to the cost reduction in a treatment. In addition, in this embodiment, it can apply also to the thing in which the wing | blade 3 is not formed.

Next, a puncture monitoring apparatus according to a third embodiment of the present invention will be described.
As in the first and second embodiments, the puncture unit monitoring apparatus according to the third embodiment is a blood circuit composed of a flexible tube used in dialysis treatment, or a flexible circuit used during transfusion or infusion. As shown in FIGS. 6 and 7, the puncture needle 1, the flexible tube 2, the wing 3, and the detecting means can be predicted. The electrode part 4, the determination part 5, the alarm means 6, and the adhesive bandage 13 which comprise are comprised mainly. In addition, the same code | symbol shall be attached | subjected about the component similar to previous embodiment, and those detailed description shall be abbreviate | omitted.

  The adhesive bandage 13 is made of a tape-like member that can be attached to a portion of the flexible tube 2 fixed to the patient. As shown in FIG. 7, the electrode portion 4 is provided on the back surface 13a (contact surface with the patient). While being formed, an adhesive is applied over the entire back surface 13a. Then, the puncture needle 1 is punctured into the patient, and an adhesive bandage 13 is attached to a fixed portion of the flexible tube 2 with the patient to fix the fixed portion to the patient, and a predetermined treatment is performed (from the puncture needle). Blood is circulated extracorporeally to purify, transfuse, or infuse.

  During treatment, when the bandage 13 is peeled off and separated from the patient, it can be determined that the fixing portion of the flexible tube 2 fixed by the bandage 13 is also separated from the patient. By issuing an alarm using the alarm means 11 of 5 or the alarm means 6 of the outside, it is possible to predict and avoid the puncture needle 1 from coming off. Therefore, according to this embodiment, since the electrode part 4 was formed in the contact surface with the patient of the adhesive bandage 13 conventionally used conventionally, a medical worker etc. provide a detection means in the fixed site | part of arbitrary positions. Can do. In addition, in this embodiment, it can apply also to the thing in which the wing | blade 3 is not formed.

Next, a puncture unit monitoring apparatus according to a fourth embodiment of the present invention will be described.
As in the first to third embodiments, the monitoring device for the puncture unit according to the fourth embodiment is a blood circuit composed of a flexible tube used in dialysis treatment, and is used for transfusion or infusion. As shown in FIGS. 8 and 9, the puncture needle 1, the flexible tube 2, the wing 3, and the detection means can be predicted. Is mainly composed of an electrode unit 4, a determination unit 5, and an alarm means 6. In addition, the same code | symbol shall be attached | subjected about the component similar to previous embodiment, and those detailed description shall be abbreviate | omitted.

  Here, as shown in FIG. 9, the electrode portion 4 is integrally formed on the outer surface of the fixed portion of the flexible tube 2. That is, a predetermined electrode pattern is formed on the outer surface of the fixed portion of the flexible tube 2 by printing or the like, and the electrode pattern and the determination unit 5 are electrically connected by the wiring H1. Then, the flexible tube 2 is fixed with a general-purpose bandage B or the like so that the electrode portion 4 comes into contact with the patient's skin, and a predetermined treatment is performed (the blood from the puncture needle is circulated extracorporeally to purify, transfuse, Infusion, etc.).

  During the treatment, when the adhesive bandage B is peeled off and the fixing portion of the flexible tube 2 is separated from the patient, the electrode unit 4 detects this, and the alarm unit 11 of the determination unit 5 or the external alarm unit 6 issues an alarm. By doing so, it is possible to predict and prevent the puncture needle 1 from coming off. According to the present embodiment, since the electrode portion 4 (detection means) is provided integrally with the outer surface of the flexible tube 2, the detection means can be fixed to the fixed part without making the patient, medical personnel, etc. aware of the detection means. Can be placed. In addition, in this embodiment, it can apply also to the thing in which the wing | blade 3 is not formed.

Next, a puncture unit monitoring apparatus according to a fifth embodiment of the present invention will be described.
As in the first to fourth embodiments, the puncture unit monitoring apparatus according to the fifth embodiment is a blood circuit composed of a flexible tube used in dialysis treatment, or a flexible device used during transfusion or infusion. As shown in FIG. 10, the puncture needle 1, the flexible tube 2, the wing 3, and the detection means are configured. The electrode unit 4, the determination unit 5, the alarm means 6, and a plurality (two in this embodiment) of adhesive bandages 14 a and 14 b are mainly configured. In addition, the same code | symbol shall be attached | subjected about the component similar to previous embodiment, and those detailed description shall be abbreviate | omitted.

  The adhesive bandages 14a and 14b are made of a tape-like member that can be attached to a portion of the flexible tube 2 that is fixed to the patient, as in the third embodiment, and on the back surface (contact surface with the patient). Each has an electrode portion 4 and an adhesive is applied over the entire back surface. Then, the puncture needle 1 is punctured into the patient, and adhesive bandages 14a and 14b are respectively attached to the fixed portion of the flexible tube 2 with the patient to fix the fixed portion to the patient, and a predetermined treatment is performed. (Blood from the puncture needle is circulated extracorporeally to purify, transfuse, instill, etc.).

  Here, the alarm unit according to the present embodiment (including both the alarm unit 11 of the determination unit 5 and the external alarm unit 6) is when the electrode unit 4 formed on the adhesive bandage 14a detects the separation from the patient. The alarm part can be alerted by changing the alarm level when the electrode part 4 formed on the adhesive bandage 14b detects the separation from the patient. That is, when the bandage 14a far from the puncture needle 1 is peeled off and the electrode part 4 detects the separation from the patient, an alarm indicating that the risk is low is given, and the bandage 14b close to the puncture needle 1 is peeled off and the electrode When the unit 4 detects the separation from the patient, an alarm indicating that the degree of risk is high is performed.

  Thereby, since the alarm level by the alarm means 6 and 11 was changed according to the distance dimension from the puncture needle 1 of each electrode part 4, the risk level in the prediction of the puncture needle 1 removal can be differentiated. Of course, it is preferable to use an alarm indicating that the degree of danger is the highest when the electrode portions 4 of both the bandages 14a and 14b detect the separation from the patient, and three or more bandages having the electrode portions 4 are provided. As such, the risk level differentiation may be set more finely. Furthermore, a plurality of electrode portions shown in the first to fourth embodiments may be combined, and the alarm level by the alarm means 6 and 11 may be changed according to the distance between each electrode portion 4 and the puncture needle 1.

  Although the present embodiment has been described above, the present invention is not limited thereto. For example, the electrode unit 4 in the touch sensor as the detection unit, the signal detection unit 7 in the determination unit 5, the signal amplification unit 8, and the contact The determination means 9, the transmission means 10, and the alarm means 11 may be formed integrally and formed on a fixed portion that is fixed to the patient.

  In the present embodiment, transmission / reception of signals between the electrode unit 4 and the determination unit 5 or transmission / reception of signals between the determination unit 5 and the external alarm means 6 is performed by wires using the wirings H1 and H2. A transmission antenna and a reception antenna may be formed on both sides to transmit and receive signals wirelessly. By wirelessly transmitting and receiving signals, it is possible to smoothly cope with the position of the bedding and changes in the posture of the patient, and it is possible to reliably transmit and receive signals.

  In addition, all of the detection means in the present embodiment is configured by a so-called touch sensor that electrically detects a state separated from a state in contact with the patient, but other forms of detection means (for example, a fixed part such as a microswitch) The distance between the patient and the patient can be physically detected). Furthermore, it is sufficient that the detection means is formed at a fixed portion with the patient, and the detection means is formed at the root of the puncture needle (other than the portion that pierces the access blood vessel at the tip), the T-shaped tube constituting the flexible tube, or the like. You may do it. The alarm means may be formed only on the determination unit 5 or only on the outside.

  During the treatment, a puncture needle or a flexible tube is formed at a fixed portion fixed to the patient, and detecting means for detecting that the fixed portion is separated from the patient, and the fixed portion is separated from the patient by the detecting means. As long as the monitoring device for the puncture unit is provided with an alarm means for alarming when detecting the above, it can also be applied to devices with different external shapes or with other functions added.

1 is an overall schematic view showing a monitoring device for a puncture unit according to a first embodiment of the present invention. The schematic diagram which shows the electrode part formed in the wing | blade in the monitoring apparatus of the same puncture part The block diagram which shows the determination part and alarm means in the monitoring apparatus of the same puncture part Overall schematic diagram showing a monitoring device for a puncture unit according to a second embodiment of the present invention The schematic diagram which shows the electrode part formed in the clamping member in the monitoring apparatus of the puncture part Overall schematic diagram showing a puncture monitoring device according to a third embodiment of the present invention Schematic showing the contact surface of the adhesive bandage with the patient in the monitoring device of the puncture unit Overall schematic diagram showing a puncture monitoring apparatus according to a fourth embodiment of the present invention The schematic diagram which shows the electrode part integrally formed in the outer surface of the flexible tube in the monitoring apparatus of the same puncture part Overall schematic diagram showing a puncture monitoring apparatus according to a fifth embodiment of the present invention

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Puncture needle 2 Flexible tube 3 Wing | blade 4 Electrode part (detection means)
5 Judgment part 6 Alarm means (signal generation means)
7 Signal detection means 8 Signal amplification means 9 Contact determination means 10 Transmission means 11 Alarm means 12 Holding member 13 Adhesive bandage 14a, 14b Adhesive bandage

Claims (6)

A puncture needle that can puncture the patient;
A flexible tube that extends from the puncture needle and that can introduce liquid into or through the patient's body through the puncture needle;
In the puncture monitoring device comprising:
A detecting means for detecting that the puncture needle or the flexible tube is fixed to a patient during treatment and detects that the fixing part is separated from the patient;
Signal generating means for generating a signal when it is detected by the detecting means that the fixed portion is separated from the patient;
A puncture part monitoring device comprising:   2. The detection means according to claim 1, wherein a plurality of the detection means are provided for the fixed part, and an alarm level by the signal generation means is changed in accordance with a distance between each detection means and the puncture needle. Puncture monitoring device.   The puncture monitoring apparatus according to claim 1, wherein the detection unit includes a touch sensor that electrically detects a state separated from a state in contact with a patient.   4. The puncture needle according to claim 1, wherein the puncture needle is composed of a winged needle having a wing at its base, and the detection means is provided on a contact surface of the wing with the patient. The puncture part monitoring apparatus as described in one.   The puncture unit according to any one of claims 1 to 3, wherein the detection means is provided on a contact surface with the patient in a bandage for fixing the flexible tube to the patient. Monitoring device.   The puncture monitoring apparatus according to any one of claims 1 to 3, wherein the detection means is provided integrally with an outer surface of the flexible tube.

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