JP7463764B2 - Liquid leakage prevention device and liquid introduction circuit blocking device - Google Patents

Description

This disclosure relates to a leakage suppression device and an introduction liquid circuit blocking device.

Hemodialysis is a treatment method that is used for patients with chronic renal failure. Hemodialysis is a treatment method in which the patient's blood is extracted using an indwelling needle from a blood vessel in which blood flow is artificially increased, called a shunt, and circulated extracorporeally in a blood circuit for several hours, purified and hydrated in an artificial kidney (dialyzer), and then returned to the patient's body.

In hemodialysis treatment, if fluid leaks from the needle inserted into the patient's arm, it is necessary to deal with the problem quickly. JP 2007-143895 A (Patent Document 1) discloses a moisture-sensing sheet that can detect even small amounts of fluid leakage, such as blood leakage.

JP 2007-143895 A

In the invention described in Patent Document 1, the sensor sheet is connected to accessory devices such as a sound source and a transmitter to inform the patient that leakage from the puncture site has been detected. Patent Document 1 explains that this allows the information to be easily transmitted to nurses, etc. The nurses, etc. who have received the information about the leakage can stop the blood pump, thereby stopping the blood circulation. However, from the perspective of effectively suppressing leakage, it is necessary to stop the blood circulation even more quickly.

The present disclosure aims to provide a leakage suppression device and an introduction liquid circuit blocking device that can quickly stop the circulation of the introduction liquid when a leakage occurs and effectively suppress leakage in a system that includes an introduction liquid circuit that is provided outside the patient's body and through which the introduction liquid to be introduced into the patient's body flows.

The leakage prevention device according to the present disclosure is a leakage prevention device for use in a system that is provided outside the patient's body and includes an introduction liquid circuit through which the introduction liquid to be introduced into the patient's body flows, and includes a detection unit capable of detecting leakage at the puncture section or a needle removal state, an opening/closing mechanism that is provided on the introduction liquid circuit and is capable of opening and closing the introduction liquid circuit, and a control unit that controls the opening/closing mechanism so that the opening/closing mechanism closes the introduction liquid circuit when leakage at the puncture section or a needle removal state is detected by the detection unit.

In one embodiment, in the leakage prevention device, the introduction liquid pump that circulates the introduction liquid through the introduction liquid circuit is stopped based on the fluctuation in pressure in the introduction liquid circuit when the opening and closing mechanism closes the introduction liquid circuit.

In one embodiment, in the leakage suppression device, the opening and closing mechanism is provided upstream of the introduction liquid circuit from the introduction liquid pump.

In one embodiment, in the leakage suppression device, the opening and closing mechanism includes a first member having a first surface, a second member having a second surface substantially parallel to the first surface, a third member having a portion facing the second member, an elastic member provided between the first member and the second member and biasing the first member and the second member in a direction to bring the first surface and the second surface closer together, and a drive unit capable of driving the third member in a direction in which the portion of the third member facing the second member approaches the second member. Under normal circumstances, the introduction liquid circuit is held between the first surface and the second surface by the biasing force of the elastic member, and when leakage or a needle removal state at the puncture portion is detected by the detection unit, the third member is driven, and the control unit controls the drive unit so that the introduction liquid circuit is sandwiched between the second member and the third member to close the introduction liquid circuit.

In one embodiment, in the leakage prevention device, the first surface and the second surface are each formed in two separate locations.

In one embodiment, in the leakage prevention device, the introduction fluid circuit includes a blood circuit through which the patient's blood flows.

In one embodiment, in the leakage prevention device, the system is an artificial dialysis system including a dialyzer connected to the blood circuit.

The introduction liquid circuit blocking device according to the present disclosure is an introduction liquid circuit blocking device that is provided outside the patient's body and is capable of blocking an introduction liquid circuit through which introduction liquid to be introduced into the patient's body flows, and includes a first member having a first surface, a second member having a second surface substantially parallel to the first surface, a third member having a portion facing the second member, an elastic member provided between the first member and the second member and biasing the first member and the second member in a direction to bring the first surface and the second surface closer together, and a drive unit capable of driving the third member in a direction in which the portion of the third member facing the second member approaches the second member, and the third member is driven from a state in which the introduction liquid circuit is held between the first surface and the second surface, and the introduction liquid circuit is sandwiched between the second member and the third member to block the introduction liquid circuit.

In one embodiment, in the introduction fluid circuit occlusion device, the introduction fluid circuit includes a blood circuit through which the patient's blood flows.

According to the present disclosure, in a system including an introduction fluid circuit installed outside the patient's body, when a fluid leak occurs, the circulation of the introduction fluid can be stopped quickly, and leakage can be effectively suppressed.

1 is a diagram showing a configuration of an artificial dialysis system including a leakage prevention device according to an embodiment of the present disclosure. 2 is a diagram showing a configuration of a detection unit included in the liquid leakage prevention device shown in FIG. 1 . 3A to 3C are diagrams (part 1) showing a procedure for providing the detection unit shown in FIG. 2 at the puncture site of a patient. 3 is a diagram (part 2) showing the procedure for providing the detection unit shown in FIG. 2 at the puncture site of the patient. 3 is a diagram (part 3) showing the procedure for providing the detection unit shown in FIG. 2 at the puncture site of the patient. 4 is a diagram (part 4) showing the procedure for providing the detection unit shown in FIG. 2 at the puncture site of the patient. 2 is a diagram (part 1) showing the configuration of an opening and closing mechanism included in the leakage prevention device shown in FIG. 1 . 2 is a diagram (part 2) showing the configuration of the opening and closing mechanism included in the leakage prevention device shown in FIG. 1 . FIG. 9 is a diagram (part 1) showing a solenoid as a drive unit included in the opening/closing mechanism shown in FIGS. 7 and 8 . FIG. 9 is a second diagram showing a solenoid as a drive unit included in the opening/closing mechanism shown in FIGS. 7 and 8 . FIG. 9 is a diagram showing a state in which the opening and closing mechanism shown in FIGS. 7 and 8 is provided on a blood circuit. 2 is a diagram showing the configuration of a control unit included in the leakage prevention device shown in FIG. 1 .

The following describes embodiments of the present disclosure. Note that in the embodiments described below, when numbers, amounts, etc. are mentioned, the scope of the present disclosure is not necessarily limited to those numbers, amounts, etc., unless otherwise specified. Furthermore, in the embodiments described below, each component is not necessarily essential to the present disclosure, unless otherwise specified.

Figure 1 is a diagram showing the configuration of an artificial dialysis system 100. As shown in Figure 1, the artificial dialysis system 100 includes a dialyzer 1, a dialysis fluid supplying device 2, a blood circuit 3 (introducing fluid circuit), a blood pump 4, and an anticoagulant injection pump 5.

Blood (introducing fluid) taken from the patient is pumped into the dialyzer 1. In the dialyzer 1, the blood comes into contact with the dialysis fluid that flows in the opposite direction to the blood through the holes in the semipermeable membrane. During this process, substances harmful to the human body, such as urea and waste products, and excess water, are transferred from the blood to the dialysis fluid, and substances lacking in the body, such as electrolytes, are replenished from the dialysis fluid to the blood.

The dialysis fluid supplying device 2 supplies dialysis fluid to the dialyzer 1 in the direction of the arrow DR2A. The dialysis fluid containing waste products that flows through the dialyzer 1 and comes into contact with the blood is returned to the dialysis fluid supplying device 2 in the direction of the arrow DR2B.

The blood circuit 3 includes a blood circuit 3A on the blood removal side and a blood circuit 3B on the blood return side. Blood taken from the patient flows through the blood circuit 3A in the direction of the arrow DR3A and reaches the dialyzer 1. Blood purified in the dialyzer 1 flows through the blood circuit 3B in the direction of the arrow DR3B and is returned to the patient.

The blood pump 4 applies pressure to the blood circuit 3 to circulate the blood. As shown in FIG. 1, the blood pump 4 is provided on the blood circuit 3A on the blood removal side.

The anticoagulant injection pump 5 is connected to the blood circuit 3A on the blood withdrawal side and supplies anticoagulant to the blood circuit 3A.

Blood is withdrawn from the patient through the puncture site 6 (puncture site 6A), purified in the dialyzer 1, and then returned to the patient's puncture site 6 (puncture site 6B) and returned to the patient's body.

It is necessary to detect blood leakage or needle dislodgement from the puncture site 6 during dialysis treatment. In particular, if needle dislodgement occurs at the puncture site 6B on the blood return side during treatment, blood flowing through the blood circuit 3 will flow out of the body. It is necessary to quickly detect such an event and prevent or minimize blood leakage.

The blood leakage prevention device according to the present embodiment is used in an artificial dialysis system 100, and includes a detection unit 10 capable of detecting blood leakage or needle removal at the puncture unit 6, an opening/closing mechanism 20 provided on the blood circuit 3 and capable of opening and closing the blood circuit 3, and a control unit 30 that controls the opening/closing mechanism so that the opening/closing mechanism 20 closes the blood circuit 3 when blood leakage at the puncture unit 6 is detected by the detection unit 10. In FIG. 1, for convenience of illustration, the opening/closing mechanism 20 is provided on the blood circuit 3A on the blood removal side, but in one typical example, the opening/closing mechanism 20 is attached to the lower part (preferably directly below) of a chamber (not shown) provided on the blood circuit 3B on the blood return side. The installation position of the opening/closing mechanism 20 is not limited to the above-mentioned position. Below, the detection unit 10, the opening/closing mechanism 20, and the control unit 30 will be described.

Figure 2 is a diagram showing the configuration of the detection unit 10. As shown in Figure 2, the detection unit 10 includes a sensor 11, a pad 12, and an adhesive tape 13. The adhesive tape 13 has a folded portion 13A. The detection unit 10 is provided in both the puncture portion 6A on the blood removal side and the puncture portion 6B on the blood return side, but in some cases it may be provided in only one of the puncture portions 6A, 6B.

The sensor 11 is made of a conductor such as silver or carbon paste. The pad 12 is made of nonwoven fabric. The adhesive tape 13 is made of rayon, synthetic fiber, acrylic adhesive, etc.

Figures 3 to 6 are diagrams showing the procedure for installing the detection unit 10 at the puncture site 6 of a patient. First, the individually packaged detection unit 10 is opened, and as shown in Figure 3, the folded-back portion 13A of the adhesive tape 13 is held and peeled off from the backing 14. Next, as shown in Figure 4, the pad 12 is placed on the puncture site (puncture site 6) of the puncture needle 7 and firmly adhered. Next, as shown in Figure 5, a part of the sensor 11 is clamped by the clip 15. Then, as shown in Figure 6, the clip 15 is attached to the puncture needle 7. The clip 15 is electrically connected to the control unit 30.

The detection unit 10 can detect blood leakage from the puncture part 6. In addition, if the puncture needle 7 is removed, the clip 15 detaches from the sensor 11, making it possible to detect needle removal. When blood leakage or a needle removal state is detected, the blood circuit 3 is closed by the opening and closing mechanism 20.

Figures 7 and 8 are diagrams showing the configuration of the opening and closing mechanism 20. Figure 7 shows the opening and closing mechanism 20 in normal operation, and Figure 8 shows the opening and closing mechanism 20 in an abnormal state, i.e., when blood leakage or needle removal at the puncture section 6 is detected by the detection section 10. The blood circuit 3 is not shown in Figures 7 and 8. As shown in Figures 7 and 8, the opening and closing mechanism 20 includes a first member 21, a second member 22, a third member 23, an elastic member 24, and a solenoid 25 (drive section).

The first member 21 has a support surface 21A and holding surfaces 21B, 21C (first surface). The second member has a protrusion 22A and holding surfaces 22B, 22C (second surface). The protrusion 22A protrudes toward the third member 23. The holding surfaces 22B, 22C are formed approximately parallel to the holding surfaces 21B, 21C of the first member 21. The third member 23 has a protrusion 23A. The protrusion 23A faces the protrusion 22A of the second member 22.

The elastic member 24 is provided between the support surface 21A of the first member 21 and the second member 22. The elastic member 24 biases the first member 21 and the second member 22 in a direction that brings the holding surfaces 21B, 21C (first surface) and the holding surfaces 22B, 22C (second surface) closer to each other. Under normal circumstances (FIG. 7), the blood circuit 3 is held between the holding surfaces 21B, 21C of the first member 21 and the holding surfaces 22B, 22C of the second member 22 by the biasing force of the elastic member 24. That is, under normal circumstances, the blood circuit 3 is held at two points (holding surfaces 21B, 21C) of the first member 21 and two points (holding surfaces 22B, 22C) of the second member 22. The holding surfaces 21B, 21C, 22B, 22C are formed in a planar shape so as not to narrow the flow path of the blood circuit 3 and obstruct the flow of blood under normal circumstances.

The solenoid 25 (drive unit) can drive the protrusion 23A of the third member 23 in a direction approaching the second member 22. When the detection unit 10 detects blood leakage or a needle-removed state at the puncture portion 6, the control unit 30 drives the third member 23 in a direction that brings the protrusion 23A of the third member 23 closer to the protrusion 22A of the second member 22 (FIG. 8). As a result, the blood circuit 3 is clamped between the protrusion 22A of the second member 22 and the protrusion 23A of the third member 23. That is, when blood leakage or a needle-removed state occurs at the puncture portion 6, the blood circuit 3 is clamped between one point (protrusion 22A) of the second member 22 and one point (protrusion 23A) of the third member 23, thereby blocking the blood circuit 3. This makes it possible to prevent or minimize blood leakage. The tips of the protrusions 22A and 23A are formed with a pointed shape (a shape that is likely to cause stress concentration) to make it easier to block the blood circuit 3.

When the blood circuit 3 is blocked, the pressure in the blood circuit 3 fluctuates (rises). At this time, the blood pump 4 stops operating based on the pressure fluctuation. This function of stopping operation is also provided in conventional blood pumps 4. Therefore, the blood leakage prevention device of this embodiment can be directly installed in an existing artificial dialysis system 100. For example, if an opening and closing mechanism 20 is installed at the bottom of a chamber provided on the blood circuit 3B on the blood return side, the pressure in the venous chamber increases as the blood circuit 3B is blocked. In the artificial dialysis system 100, the pressure in the venous chamber is constantly monitored, so the increase in pressure can be detected using existing equipment. When an increase in pressure in the blood circuit 3B is detected, the operation of the blood pump 4 stops.

Figures 9 and 10 are diagrams showing the solenoid 25. As shown in Figures 9 and 10, the solenoid 25 includes a rod-shaped member 25A and a coil 25B. When a current flows through the coil 25B, the rod-shaped member 25A is driven in the axial direction, and the third member 23 is driven in a direction in which the protrusion 23A of the third member 23 approaches the protrusion 22A of the second member 22.

Figure 11 is a diagram showing the state in which the opening and closing mechanism 20 is provided on the blood circuit 3. As shown in Figure 11, under normal circumstances, the blood circuit 3 is held between the first member 21 and the second member 22 by the biasing force of the elastic member 24.

Figure 12 is a diagram showing the configuration of the control unit 30. As shown in Figure 12, the control unit 30 includes a microcomputer 31, resistors 32 (32A, 32B), a switch circuit 33, and a power supply 34.

The microcomputer 31 is electrically connected to the clip 15 of the detection unit 10. The microcomputer 31 receives a signal from the detection unit 10 in the event of an abnormality (blood leakage or needle removal), and issues a command to drive the solenoid 25 according to a preprogrammed pattern. The solenoid 25 is driven by a switch circuit 33 and a power source 34 connected to the microcomputer 31 via a resistor 32.

The artificial dialysis system 100 according to this embodiment can quickly stop blood circulation when leakage (blood leakage or needle dislodgement) occurs, effectively preventing blood leakage.

In this embodiment, a blood leakage prevention device used in the artificial dialysis system 100 has been described as an example of a blood leakage prevention device, but the blood leakage prevention device is not limited to this, and a similar configuration can be applied to, for example, monitoring blood leakage and needle removal in an infusion pump or a syringe pump.

Although the embodiments of the present disclosure have been described above, the embodiments disclosed herein should be considered to be illustrative in all respects and not restrictive. The scope of the present disclosure is defined by the claims, and is intended to include all modifications within the meaning and scope of the claims.

1 Dialyzer, 2 Dialysis fluid supply device, 3, 3A, 3B Blood circuit, 4 Blood pump, 5 Anticoagulant injection pump, 6, 6A, 6B Puncture part, 7 Puncture needle, 10 Detection part, 11 Sensor, 12 Pad, 13 Adhesive tape, 13A Folded part, 14 Mounting paper, 15 Clip, 20 Opening and closing mechanism, 21 First member, 21A Support surface, 21B, 21C Holding surface, 22 Second member, 22A Protrusion, 22B, 22C Holding surface, 23 Third member, 23A Protrusion, 24 Elastic member, 25 Solenoid, 25A Rod-shaped member, 25B Coil, 30 Control unit, 31 Microcomputer, 32, 32A, 32B Resistor, 33 Switch circuit, 34 Power source, 100 Artificial dialysis system.

Claims (8)

A leakage prevention device for use in a system including an introduction liquid circuit provided outside a patient's body and through which an introduction liquid to be introduced into the patient's body flows,
A detection unit capable of detecting leakage or needle removal at the puncture part;
an opening/closing mechanism provided on the introduction liquid circuit and capable of opening and closing the introduction liquid circuit;
a control unit that controls the opening and closing mechanism to close the introduction liquid circuit when the detection unit detects a liquid leakage or a needle removal state in the puncture unit ,
The opening and closing mechanism includes:
a first member having a first surface;
a second member having a second surface generally parallel to the first surface;
a third member having a portion facing the second member;
an elastic member provided between the first member and the second member and configured to bias the first member and the second member in a direction in which the first surface and the second surface approach each other;
a drive unit capable of driving the third member in a direction in which a portion of the third member facing the second member approaches the second member,
In a normal state, the introduction liquid circuit is held between the first surface and the second surface by the biasing force of the elastic member,
A leakage prevention device, in which, when the detection unit detects leakage or a needle withdrawal state at the puncture portion, the control unit controls the drive unit so that the third member is driven and the second member and the third member clamp the introduction liquid circuit to block the introduction liquid circuit . The leakage suppression device according to claim 1, wherein an introduction liquid pump that circulates the introduction liquid through the introduction liquid circuit is stopped based on a change in pressure in the introduction liquid circuit when the opening/closing mechanism closes the introduction liquid circuit. The leakage prevention device according to claim 2, wherein the opening and closing mechanism is provided upstream of the liquid introduction circuit from the liquid introduction pump. The leakage prevention device according to claim 1 , wherein the first surface and the second surface are each formed in two separate locations. 5. The leakage prevention device according to claim 1, wherein the introduction liquid circuit includes a blood circuit through which the patient's blood flows. 6. The leakage prevention device according to claim 5 , wherein the system is an artificial dialysis system including a dialyzer connected to the blood circuit. An introduction liquid circuit blocking device that is provided outside a patient's body and is capable of blocking an introduction liquid circuit through which an introduction liquid to be introduced into the patient's body flows,
a first member having a first surface;
a second member having a second surface generally parallel to the first surface;
a third member having a portion facing the second member;
an elastic member provided between the first member and the second member and configured to bias the first member and the second member in a direction in which the first surface and the second surface approach each other;
a drive unit capable of driving the third member in a direction in which a portion of the third member facing the second member approaches the second member,
an introduction liquid circuit closing device, wherein the third member is driven from a state in which the introduction liquid circuit is held between the first surface and the second surface, and the introduction liquid circuit is clamped between the second member and the third member to close the introduction liquid circuit. The introduction fluid circuit occlusion device according to claim 7 , wherein the introduction fluid circuit includes a blood circuit through which the patient's blood flows.

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