WO2014162358A1

WO2014162358A1 - Extracorporeal circulation device

Info

Publication number: WO2014162358A1
Application number: PCT/JP2013/002368
Authority: WO
Inventors: 知樹櫨田; 強長谷川
Original assignee: テルモ株式会社
Priority date: 2013-04-05
Filing date: 2013-04-05
Publication date: 2014-10-09

Abstract

An extracorporeal circulation device for circulating the blood of a patient outside the body is equipped with a clamp capable of blocking a tube forming a channel for blood, a control unit for controlling the operation of the clamp, and a temperature sensor. Therein, the clamp is provided with a heating unit for heating the tube on the basis of detection results from the temperature sensor, and a pressing member for applying pressure to and blocking the tube heated by the heating unit.

Description

Extracorporeal circulation device

The present invention relates to an extracorporeal circulation device.

Conventionally, in a circulation device that performs extracorporeal circulation, auxiliary circulation, etc., when an abnormality is detected in bubbles, pressure, flow rate, etc., the clamp is closed in conjunction with the abnormality detection, and blood feeding through the tube is stopped. A control function is provided. Patent Document 1 discloses a device that interrupts the supply of blood carried to a patient when bubbles are detected in an extracorporeal circuit.

JP 2001-346871 A

However, in the technique described in Patent Document 1, when the ambient air temperature is low, the tube temperature also decreases, and the tube becomes hard, so that the blocking ability of the clamp may decrease. In some cases, there is a possibility that the closing operation may not be performed successfully even though an abnormality is detected.

On the other hand, there is a problem that the size of the clamp itself becomes large when trying to realize a closing force that can close even a hardened tube.

In view of the above problems, an object of the present invention is to improve the occlusion ability of a clamp with an appropriately sized clamp even when the ambient temperature is lowered.

An extracorporeal circulation apparatus according to the present invention that achieves the above object is as follows.
An extracorporeal circulation device for circulating the blood of a subject outside the body,
A clamp capable of closing the tube serving as the blood flow path;
A control unit for controlling the operation of the clamp;
A temperature sensor;
The clamp is
A heating unit for heating the tube based on a detection result of the temperature sensor;
A pressing member that presses and closes the tube heated by the heating unit;
It is characterized by providing.

According to the present invention, even when the ambient temperature is lowered, it is possible to improve the closing ability of the clamp with an appropriately sized clamp.

Other features and advantages of the present invention will become apparent from the following description with reference to the accompanying drawings. In the accompanying drawings, the same or similar components are denoted by the same reference numerals.

The accompanying drawings are included in the specification, constitute a part thereof, show an embodiment of the present invention, and are used to explain the principle of the present invention together with the description.
It is a figure which shows the whole structure of the extracorporeal circulation apparatus which concerns on one Embodiment of this invention. It is a figure which shows an example of a function structure of the controller of the extracorporeal circulation apparatus which concerns on one Embodiment of this invention. It is a figure which shows an example of the whole structure of the clamp which concerns on one Embodiment of this invention. It is a figure which shows an example of the heating part which concerns on one Embodiment of this invention.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The embodiments described below are preferred specific examples of the present invention, and thus various technically preferable limitations are given. However, the scope of the present invention is particularly limited in the following description. As long as there is no description of the effect, it is not restricted to these aspects.

<1. Overall configuration of extracorporeal circulation device>
1A of FIG. 1 is a diagram illustrating an example of the overall configuration of the extracorporeal circulation device 100 according to the first embodiment of the present invention.

The extracorporeal circulation apparatus 100 is used not only for extracorporeal circulation such as cardiac surgery but also for auxiliary circulation procedures such as PCPS (percutaneous cardiopulmonary support) and ECMO (extracorporeal membrane oxygenation), and performs cardiopulmonary assist operations (extracorporeal circulation operation, priming operation). Do. The extracorporeal circulation apparatus 100 has a blood extracorporeal circuit (hereinafter referred to as a circulation circuit) indicated by an arrow in the figure. In the extracorporeal circulation apparatus 100, after performing the priming operation, the blood of the subject 130 is circulated extracorporeally using this circulation circuit.

Here, the priming operation refers to an operation of removing the bubbles in the circuit by circulating the priming solution in the circulation circuit in a state where the circulation circuit is sufficiently filled with the priming solution (for example, physiological saline).

The extracorporeal circulation device 100 includes a controller 110 that functions as a control device, a drive motor 111, a centrifugal pump 112, an oxygenator 113, an oxygen supply source 117, a catheter (venous side) 119, and a catheter (arterial side) 120. A bubble sensor 114, a flow sensor 115, a blood filter 116, a branch line 118, a clamp 122, and a pressure sensor 123. These components are connected by a flexible tube or the like, and the lumen of the tube forms a flow path for blood or priming liquid.

The catheter (arterial side) 120 pumps blood toward the body of the subject 130, and the catheter (venous side) 119 performs blood removal from the body of the subject 130.

The centrifugal pump 112 is also called a centrifugal artificial heart, drives a rotating body provided inside, applies pressure to the blood, and circulates the blood in the circulation circuit. The drive motor 111 gives a rotational driving force to the rotating body of the centrifugal pump 112. The pressure in the circulation circuit before being pressurized by the centrifugal pump 112 is detected by the pressure sensor 123.

The artificial lung 113 performs blood circulation and blood gas exchange (oxygen addition, carbon dioxide removal, etc.). The oxygen supply source 117 is realized by, for example, an oxygen cylinder and supplies oxygen to be added to blood. The oxygen supplied from the oxygen supply source 117 is used at the time of gas exchange by the artificial lung 113.

The bubble sensor 114 detects bubbles contained in the priming liquid (or blood) flowing in the circulation circuit during the priming operation (or during the extracorporeal circulation operation) by a predetermined detection method (ultrasonic wave, light, etc.). The blood filter 116 filters blood or removes bubbles in the blood. The flow sensor 115 includes, for example, a built-in ultrasonic transceiver, and detects the flow rate of the priming liquid (or blood) in the circulation circuit.

The clamp 122 is a member for closing the tube so as to forcibly stop the blood supply toward the body of the subject 130 during the extracorporeal circulation operation.

The branch line 118 switches the flow path of the circulation circuit. Specifically, when the blood of the subject 130 is circulated extracorporeally, a circulation circuit passing through the body of the subject 130 is constructed as shown in 1A of FIG. Circulate. During the priming operation, as shown in 1B of FIG. 1, the circuit of the circulation circuit to the inside of the body of the subject 130 is blocked by the branch line 118 (in other words, the circulation circuit that passes only the outside of the subject 130 (in other words, the subject A circulation circuit that does not pass through the body of the person 130 is constructed, and the circulation circuit is filled with the priming liquid (without passing through the body of the subject) to circulate the priming liquid. On the circulation circuit, one or a plurality of bubble discharge ports (not shown) for discharging bubbles are provided. By circulating a plurality of priming liquids in the circulation circuit, the bubbles in the circulation circuit are circulated. It will be discharged from the bubble discharge port.

The controller 110 comprehensively controls the extracorporeal circulation operation and the priming operation in the extracorporeal circulation device 100. In the controller 110, for example, the centrifugal motor 112 is driven by controlling the drive motor 111, or the gas exchange operation is performed by controlling the artificial lung 113. Further, the bubble sensor 114 is controlled to acquire an output signal from the bubble sensor 114, and the flow rate sensor 115 and the pressure sensor 123 are controlled to acquire a flow rate value and a pressure value. Further, when an abnormality that requires blood supply to be stopped is detected based on output signals from the bubble sensor 114, the flow sensor 115, and the pressure sensor 123, the clamp 122 is closed.

Next, the flow of processing when performing cardiopulmonary assist operation (extracorporeal circulation operation, priming operation) using the extracorporeal circulation device 100 shown in FIGS. 1A and 1B will be briefly described.

When the cardiopulmonary assist operation is started, the controller 110 controls the execution of the priming operation. During the priming operation, a circulation circuit that does not pass through the body of the subject 130 is constructed by the branch line 118 as shown in 1B of FIG. At this time, the priming liquid supply source 121 is connected to the branch line 118, and the priming liquid is supplied from the priming liquid supply source 121 into the circulation circuit. As a result, the circulation circuit is filled with the priming liquid.

Then, the centrifugal pump 112 is driven by the control of the controller 110, and the priming liquid circulates in the circulation circuit a plurality of times. Bubbles in the circulation circuit are discharged from the bubble discharge port or the like with this circulation. At this time, bubbles in the circulation circuit are detected by the bubble sensor 114, and the controller 110 determines whether or not there are bubbles contained in the circulation circuit and the size of the bubbles based on the detection result of the bubble sensor 114. .

Here, in the controller 110, when the result of the determination satisfies a predetermined standard, the priming operation is terminated. At the end of this, the controller 110 notifies the user that the priming operation has ended using a display (not shown), a speaker (not shown), or the like. The user who receives the notification of the end of the priming operation switches the branch line 118 and constructs a circulation circuit that passes through the body of the subject 130 as shown in 1A of FIG. Thereby, the blood of the subject 130 is circulated extracorporeally.

When the extracorporeal circulation operation starts, blood that has been removed from the catheter (vein side) 119 enters the oxygenator 113 via the centrifugal pump 112. In the artificial lung 113, as described above, gas exchange, that is, processing such as oxygen addition and carbon dioxide removal is performed. Thereafter, the filtered blood is sent from the catheter (arterial side) 120 into the body of the subject 130 through the blood filter 116 and the like. This process from blood removal to blood transfer is repeated, and the blood of the subject 130 is circulated extracorporeally.

The above is an explanation of an example of the overall configuration of the extracorporeal circulation device 100 according to the present embodiment and the flow of cardiopulmonary assist operation. Note that the configuration of the extracorporeal circulation device 100 shown in FIGS. 1A and 1B is merely an example, and the configuration may be changed as appropriate.

<2. Functional configuration of controller>
Next, an example of a functional configuration of the controller 110 illustrated in FIG. 1 will be described with reference to FIG.

The controller 110 includes a display unit 203, an operation unit 202, a storage unit 201, an I / F unit 206, a timer unit 204, a communication unit 207, and a control unit (computer) 205 as functional configurations. .

The display unit 203 is realized by, for example, a display such as a monitor (including an output unit that outputs an alarm sound), and displays various types of information to the user. The operation unit 202 is realized by various buttons, for example, and inputs an instruction from a medical worker. Part or all of the display unit 203 and the operation unit 202 may be realized as a touch panel with an audio speaker, for example.

The storage unit 201 is realized by, for example, a storage medium such as a hard disk and stores various types of information. The I / F unit 206 exchanges various signals with an external device. Note that output signals from the bubble sensor 114, the flow sensor 115, and the pressure sensor 123 are taken into the controller 110 via the I / F unit 206. The timer unit 204 measures various times.

The communication unit 207 communicates with the communication unit 211 attached to the medical staff. Note that the communication between the communication unit 207 and the communication unit 211 may be short-range wireless communication such as Bluetooth (registered trademark) or wireless communication using a wireless LAN such as Wi-Fi.

The control unit 205 includes, for example, a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like, and a program for realizing the above-described cardiopulmonary assist operation is stored in the ROM. It shall be.

The above is an explanation of an example of the functional configuration of the controller 110. Note that the functional configuration shown in FIG. 2 is merely an example, and a new configuration may be added, or unnecessary configuration may be omitted as appropriate. For example, the storage unit 201 (such as a hard disk) is not necessarily provided and may be omitted.

<3. Clamp configuration>
Hereinafter, the configuration of the clamp 122 of the extracorporeal circulation apparatus 100 according to the present embodiment will be described. FIG. 3 is a diagram illustrating an example of the overall configuration of a clamp according to an embodiment of the present invention.

The clamp 122 can block a tube that becomes a blood flow path. The clamp 122 is based on a manual mode in which a medical worker (user) performs an occlusion operation by inputting an occlusion instruction on the controller 110, and output signals from the bubble sensor 114, the flow sensor 115, the pressure sensor 123, and the like. When it is determined that an abnormality that immediately stops the blood supply has occurred, it is possible to operate in the automatic control mode that automatically performs the closing operation.

In FIG. 3, the clamp 122 includes a lid 1221, a main body 1222, a temperature sensor 1223 that detects the temperature of the flexible tube 301, and a heating unit that heats the tube based on the detection result of the temperature sensor. 1224 and a pressing member 1225 that presses and closes the tube heated by the heating unit. The upper view is a side view of the clamp 122, and the lower view is a top view with the lid portion 1221 of the clamp 122 opened. However, the method is not limited to a method in which the temperature sensor 1223 is installed in the clamp 122 and the temperature of the tube 301 is directly measured. A method of estimating the temperature of the tube 301 by installing it in the controller 110 or the like and determining the temperature of the tube 301 or a method of estimating the temperature of the tube 301 from a temperature measurement sensor (not shown) of blood flowing in the tube 301 is used. You can also. Moreover, you may estimate the temperature of the tube 301 from both information.

The lumen of the tube 301 is a flow path for blood or priming liquid. The main body 1222 is provided with a cavity 302 for placing the tube 301 thereon.

The clamp 122 urges the pressing member 1225 by an urging member (not shown) such as an elastic spring in the manual mode or the automatic control mode, and moves it in the direction of the arrow 303. As the pressing member 1225 moves, the tube 301 is pushed down and can be closed. In FIG. 3, the pressing direction of the pressing member 1225 and the longitudinal direction of the tube 301 are orthogonal to each other.

Here, since the tube 301 becomes hard when the temperature of the tube 301 is low, the pressing member 1225 is not sufficiently pushed into the tube 301 side, and the closing operation may not be successful. Therefore, a heating unit 1224 for heating the tube 301 is provided at the position shown in FIG. The heating unit 1224 according to the present embodiment has, for example, a ring shape as shown by 1224-1 in FIG. 4, and is configured such that no member is disposed at an opposing position along the pressing direction of the pressing member 1225. . In the example of FIG. 3, a ring-shaped opening is located at an opposing position along the pressing direction of the pressing member 1225. The pressing member 1225 has a cylindrical shape, and the outer diameter of the cylindrical pressing member 1225 is less than the inner diameter of the ring-shaped heating unit 1224.

This is to prevent the impact during the closing operation by the pressing member 1225 from being directly applied to the heating unit 1224. In addition, since the temperature of the tube 301 in the vicinity where the pressing member 1225 comes into contact needs to be sufficiently warmed, it is desirable to arrange the heating unit 1224 within a predetermined distance from the contact portion between the pressing member 1225 and the tube 301. .

Thus, in order to reduce the impact caused by the pressing of the pressing member 1225 and to arrange in the vicinity of the contact portion between the pressing member 1225 and the tube 301, the heating unit 1224 has a ring shape.

The control unit 205 detects the temperature of the tube 301 by the temperature sensor 1223, and controls the heating unit 1224 so that the tube 301 becomes a predetermined temperature based on the detection result. Thereby, since the temperature of the tube 301 is maintained at an appropriate temperature, the pressing member 1225 can be sufficiently pushed in, and a satisfactory closing operation of the tube 301 can be realized. Since the appropriate temperature of the tube 301 is determined for each material constituting the tube 301, it may be held in advance as a parameter. Alternatively, the user may be configured to be able to input via the operation unit 202 or the display unit 203.

The heating unit 1224 is not limited to a ring shape, and may be a shape in which a part of a flat rectangular parallelepiped is cut out, for example, as shown in 1224-2 of FIG. Furthermore, it may be a shape in which a part of the ring shape is discontinuous like a C-shape (not shown). Any shape may be used as long as the member is not disposed at the tip of the pressing member 1225 in the moving direction.

As described above, according to the present embodiment, even when the ambient temperature is lowered, it is possible to improve the occlusion ability of the clamp with an appropriately sized clamp.

The present invention is not limited to the above embodiment, and various changes and modifications can be made without departing from the spirit and scope of the present invention. Therefore, in order to make the scope of the present invention public, the following claims are attached.

Claims

An extracorporeal circulation device for circulating the blood of a subject outside the body,
A clamp capable of closing the tube serving as the blood flow path;
A control unit for controlling the operation of the clamp;
A temperature sensor;
The clamp is
A heating unit for heating the tube based on a detection result of the temperature sensor;
A pressing member that presses and closes the tube heated by the heating unit;
An extracorporeal circulation device comprising:
The extracorporeal circulation apparatus according to claim 1, wherein the heating unit is not disposed at an opposing position along the pressing direction of the pressing member.
The heating unit is configured in a ring shape,
The extracorporeal circulation device according to claim 2, wherein the ring-shaped opening is located at a position facing the pressing direction of the pressing member.
The pressing member is configured in a cylindrical shape,
The extracorporeal circulation device according to claim 3, wherein an outer diameter of the cylindrical pressing member is less than an inner diameter of the ring-shaped heating portion.
The extracorporeal circulation device according to any one of claims 1 to 4, wherein the heating unit heats the tube so as to reach a predetermined temperature based on a detection result of the temperature sensor.
The extracorporeal circulation device according to any one of claims 1 to 5, wherein the heating unit is disposed within a predetermined distance from a portion of the tube pressed by the pressing member.
The extracorporeal circulation device according to any one of claims 1 to 6, wherein a pressing direction of the pressing member and a longitudinal direction of the tube are orthogonal to each other.
The extracorporeal circulation device according to any one of claims 1 to 7, wherein the temperature sensor detects the temperature of the tube.
The temperature sensor detects the temperature of the liquid flowing through the tube,
The extracorporeal circulation apparatus according to claim 1, wherein the heating unit heats the tube based on a temperature of the liquid.