JP2001029459A - Liquid supply system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To supply a liquid into a blood vessel at a predetermined temperature during a medical treatment. SOLUTION: This system 100 for use in a medical treatment for continually supplying a predetermined liquid into a blood vessel (or body) at a predetermined temperature (T0) has a temperature regulating unit 108 which regulates the temperature of the liquid injected into the blood vessel 104, and a pump 110 which injects the liquid into the blood vessel via the temperature regulating unit and a line 114. Control of the liquid temperature by the temperature regulating unit is effected allowing for heat transfer between the liquid and its environment until the liquid discharged from the temperature regulating unit is injected into the blood vessel.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a system used for injecting a liquid into a blood vessel (or body) at a predetermined temperature during various treatments in the medical field of mammals, particularly humans, such as an extracorporeal circulation device ( Or a system). An extracorporeal circulation device (or system) is a device that discharges a body fluid (eg, blood) from the body, processes it in a predetermined manner (eg, dialysis treatment), and then returns the body fluid to the body again. A device (or system) that drains and instead injects another liquid (called a replacement fluid, such as Ringer's solution) into the body.

The system of the present invention is disclosed in, for example,
"Separation cooling method" as disclosed in Japanese Patent No. 90021 (or "separation heating method" in which heating is performed instead of cooling).
Thereby, it can be particularly advantageously integrated into an extracorporeal circulation device (or system) that can be used if a part of the body as a subject is to be kept at a predetermined temperature.

[0003]

2. Description of the Related Art The above-mentioned extracorporeal circulation device (or system)
As described in JP-A-9-290021, (1) a replacement fluid injection unit for cooling a replacement fluid (or diluent) and metering it into a body (accordingly, a blood vessel);
A blood concentration unit for measuring and drawing out (or blood removal) the diluted blood diluted by the replacement fluid from the body (according to the blood vessel), and concentrating the extracted diluted blood, and (3) heating the concentrated blood and measuring it in the blood vessel It has a blood infusion unit for injecting. By using such an extracorporeal circulation device, the separation cooling method can be efficiently performed. The contents disclosed in this publication and applicable to the system of the present invention described below constitute a part of the present specification by this citation.

[0004]

In order to carry out the separation cooling method more smoothly, the above-mentioned proposed extracorporeal circulation apparatus was further studied, and as a result, the separation cooling method was more effectively carried out. Above, it is necessary to more accurately control the temperature of a subject (or site, for example, an organ such as the brain, hereinafter simply referred to as a “subject”) which is a part of the body to which the separation cooling method is applied, and Found that it is important to control the temperature of the replacement fluid actually injected into the body to a predetermined temperature when injecting replacement fluid into the body using the above-described extracorporeal circulation device (or system). .

[0005] That is, when applying a separation temperature control method for controlling a subject, which is a part of the body, to a predetermined temperature in accordance with the treatment of the subject, it is necessary to control the temperature of the replacement fluid to be injected into the body as accurately as possible. Has found that the temperature control of the object to which the separation temperature control method is applied can be more accurately performed, and therefore, the separation temperature control method can be more effectively performed.

In Japanese Patent Application Laid-Open No. 9-290021,
Depending on the predetermined temperature to cool the target, the temperature of the replacement fluid itself to be injected into the body is controlled in advance by the heat exchanger placed in the middle of the conduit through which the replacement fluid passes to the set temperature. However, no consideration is given to the temperature at the time the replacement fluid is injected into the body, as in the present invention as described in detail below.

[0007]

In the conventional control as described above, a fluid as a replacement fluid is supplied to a blood vessel (or a body).
Regardless of the temperature at the time of injection into the body, the liquid whose temperature has been previously adjusted to a predetermined temperature in the heat exchanger will be injected into the body. In this case, the time at which the liquid is injected into the blood vessel (or the body) The temperature of the liquid is not always maintained at the predetermined temperature, which is not desirable for bringing the target temperature to the predetermined temperature by a separation temperature control method such as a cooling separation method. Was found. Therefore, when injecting a liquid into a blood vessel (or the body), it is necessary to devise a technique that makes the temperature of the liquid injected into the blood vessel (or the body) closer to a predetermined temperature.

When a liquid is injected into the body, it is usually injected into a blood vessel in many cases. However, it is not a blood vessel, but a body cavity (thoracic cavity, abdominal cavity, etc.) or an organ within the body cavity (eg, a digestive organ (stomach, intestine, etc.)). ), Urinary organs (such as the bladder), reproductive organs (the uterus,
Vagina etc.)) may be directly injected without passing through blood vessels (for example, for the purpose of washing and nutritional supply), so unless otherwise noted, the term “in the body”
It is used herein as a concept including the case of injecting into a "blood vessel" (or in a blood vessel) and the case of injecting into "another part" as described above. Also, in the following description, a case will be mainly described as an example of injecting into a “blood vessel”. However, when such a description is applicable to other places,
The term “in a blood vessel” will be understood to include the meaning “in other places”.

[0009] When applying the separation temperature control method using an extracorporeal circulation device (or system), the type of target to which the separation temperature control method is applied and the type of treatment for it (eg, surgery, maintenance of a low activity state) How many degrees Celsius the subject needs to be maintained (eg, how many degrees Celsius
Is required to be cooled, or to what degree the temperature needs to be heated), that is, the predetermined temperature of the subject is determined, and based on that, the fluid of what degree and the flow rate to the blood vessel (or the body) It is decided whether injection is necessary. Such a determination can be appropriately selected, for example, by a physician, depending on the treatment applied to the subject. In the present invention, the liquid is
The liquid need not be a pure liquid, and is not particularly limited as long as it can be handled in the same manner as a liquid. For example, a liquid containing a solid such as a solution or blood (dispersion, suspension) Etc.) are also included in the liquid.

When injecting a liquid into the body, it is necessary to devise a technique for making the temperature of the liquid at the time of injecting the body closer to a predetermined temperature because the above-described separation temperature control method is applied. Not only in the case of medical (or medical) procedures, but also in various other medical (or medical) procedures such as dialysis, blood transfusion and the like. Therefore, although the present invention will be described below mainly with reference to an example in which the present invention is incorporated into a separation temperature control method, the present invention is applicable to various other medical treatments where it is desirable to inject a liquid at a predetermined temperature into the body (for example, Transurethral surgery, enteral nutrition therapy, hyperthermia, contrast medium injection, hypothermia, anticancer drug injection, infusion for critically ill patients, vaginal surgery, etc.).

The present invention is a system used for a medical treatment for continuously supplying a predetermined liquid to a blood vessel (or a body) at a predetermined temperature (T0), wherein the temperature for controlling the temperature of the liquid to be injected into the blood vessel is controlled. A temperature control unit and a pump for injecting liquid into the blood vessel (or body) via the temperature control unit and the conduit, wherein the temperature control of the liquid in the temperature control unit is such that the liquid leaving the temperature control unit is A liquid supply system is provided that takes into account heat transfer between a liquid and its surrounding environment until it is injected into (or into the body).

With such a system, the temperature of the liquid to be injected into the blood vessel can be brought closer to or at a predetermined temperature (T0) at the time of injection into the blood vessel. As a result, for example, when performing a medical treatment such as a separation temperature control method, by incorporating the system of the present invention into the external circulation device, it becomes possible to inject the replacement fluid into the body at a predetermined temperature, and to increase the separation temperature. A control can be performed at a temperature closer to, and preferably substantially at, the target temperature to which the control method is applied, and thus the separation temperature control method can be performed more effectively. .

In the system of the present invention, the temperature of the liquid in the temperature control unit is controlled by the environment around the liquid (generally the system is placed) that occurs before the liquid exiting the temperature control unit is injected into the blood vessel. This is performed in consideration of heat transfer between the atmosphere of the room and the liquid.
No such consideration has ever been made in the field of medical treatment. This takes into account the change in the thermal state during the flow of the liquid exiting the temperature control unit until it is injected into the blood vessel, i.e., whether heat is radiated or absorbed, or is insulated. This means that the change in the state is fed back to the temperature control unit; anticipating the change; or a combination of both, to control the temperature of the liquid in the temperature control unit.

In one embodiment of the present invention, the temperature of the liquid at the time of injection into the blood vessel (injected liquid), for example, to release heat to the environment when passing through a conduit as a flow path from the temperature control unit to the blood vessel. When the temperature (T1) is lower than the predetermined temperature (T0), an extra amount of heat to be dissipated is added in advance in the temperature control unit. Further, for example, due to insufficient heating, the injection liquid temperature (T1) is increased to a predetermined temperature (T1).
If it is lower than 0), the amount of heat considered to be insufficient is added to the heat in the temperature control unit. Furthermore, when the injection liquid temperature (T1) is lower than the predetermined temperature (T0) due to excessive cooling in the temperature control unit, the cooling in the temperature control unit is suppressed.

Conversely, as a result of absorbing heat from the environment, for example, when passing through a conduit, the temperature of the injected liquid (T1) rises to a predetermined temperature (T1).
If it is higher than 0), the amount of heat which will be absorbed by the conduit is reduced (or extra cooled) from the amount to be heated in the temperature control unit. Also, due to overheating in the temperature control unit, the injection liquid temperature (T
If 1) is higher than the predetermined temperature (T0), the amount of heating considered to be excessive is reduced in the temperature control unit.

In addition, if no heat transfer is observed when the liquid passes through the conduit and it is substantially insulated, the temperature of the liquid in the temperature control unit will be the same since the unit outlet temperature will be the same as the injected liquid temperature. Is set to a predetermined temperature (T
Set to 0). By doing so, the injection liquid temperature (T
1) becomes the predetermined temperature (T0), and in this case, the temperature adjustment unit may maintain that state.

In the above-described embodiment, in consideration of the heat transfer, the temperature at the time when the liquid enters the blood vessel, that is, the infused liquid temperature (T1)
Is required to be compared to a predetermined temperature (T0), and therefore a first sensor is used to measure the temperature of the injected liquid.

Accordingly, in one preferred embodiment, the system of the present invention exits from a first sensor that measures the temperature of the liquid at the time of infusion into the blood vessel (or body) (infusion liquid temperature T1), and a temperature control unit. The liquid temperature control in the temperature control unit, which further includes a second sensor for measuring the temperature of the liquid (unit outlet temperature T2), taking into account the heat transfer between the liquid and the surrounding environment, includes: At the initial setting temperature, the temperature control unit
Also, start the operation of the system by operating the pump,
(2) The injection liquid temperature (T1) is measured, and (3) the temperature difference ΔTa (= T0−T1) between the predetermined temperature (T0) and the injection liquid temperature (T1) to be measured is obtained, and (a) ΔTa> In the case of 0, (b) so as to increase the unit outlet temperature (T2)
When ΔTa <0, the unit outlet temperature (T2) is lowered, or (c) when ΔTa = 0, the unit outlet temperature (T2) is maintained. That is, ΔT
Apply a kind of feedback control, which returns the information of a to the temperature control unit and controls it.

In the above-described embodiment, in a particularly preferable case, after performing the temperature control of the liquid in the temperature control unit in consideration of the heat transfer between the liquid and the surrounding environment, the steps (2) and (3) are performed. Repeat while the system is running.

In this system, the step (2) and the step (3) are carried out in such a manner that the injection liquid temperature is measured continuously or intermittently, and accordingly, the calculation of ΔTa and the temperature of the temperature control unit are performed. The control may also be performed by performing the control continuously or intermittently, and this is preferably repeated to make ΔTa close to zero. Note that the initial set temperature of the temperature control unit is an initial value of a temperature that is set in advance during operation of the system, and may be any appropriate temperature, but is generally a predetermined temperature (T
0), but if it is expected that ΔTa> 0, the temperature may be higher than the predetermined temperature.
May be lower.

In the present invention, the temperature adjusting unit for adjusting the temperature of the liquid to be injected is generally at about 0 ° C. to 50 ° C., preferably at about 1 ° C. to 45 ° C. Any suitable known temperature control unit may be used as long as it can control the temperature. In such a temperature control unit, by setting a desired unit outlet temperature, a heating means (preferably, for example, an electric heater) or a cooling means (preferably, for example, a Peltier element) in the unit is operated to heat the temperature control unit. By adjusting the temperature of the medium, the liquid passing through the unit can be adjusted to the set unit outlet temperature (T2).

This temperature control unit measures the unit outlet temperature (T2) by means of a second sensor which measures the temperature of the liquid exiting the unit and, if there is a difference between it and the set temperature, any suitable control The unit outlet temperature (T2) is brought close to the set value by heating or cooling in a system, and this is repeated as necessary, and finally the unit outlet temperature (T2) is controlled by finally setting the set value.

For example, the temperature control unit has a cooling means and a heating means in a water bath, adjusts the temperature of the heat medium (usually water) in the bath by these means, and allows the liquid to be injected to pass. By conventional indirect heat exchange, the conduit is immersed in this bath (preferably in a spiral form) so that the liquid is substantially at the temperature of the bath while the liquid passes through the conduit in the bath. The temperature of the liquid can be adjusted. The temperature control unit may have only one of the cooling means or the heating means if it is known in advance that the on / off operation of one of the cooling means is sufficient for the operation of the system. .

The control method of the temperature control unit based on ΔTa may be any method. For example, in the simplest case, the control may be performed by turning on / off the heating or cooling means according to the sign of ΔTa. In a preferred embodiment, any preferred method such as proportional control, differential control, integral control, or any combination thereof including changing the operation time, output, etc. of the heating or cooling means according to the magnitude of the absolute value of ΔTa May be used.

In the present invention, the environment is the atmosphere around the liquid after it leaves the temperature control unit and before it is injected, and is generally the atmosphere of the room in which the system is arranged. If the conduit through which the liquid passes is inserted into the body at a significant length, the liquid may be heated or cooled by body temperature, and it is inserted if it is preferable to take this into account The body part around the conduit part is also included in the environment. It is not necessary to include such body parts in the environment if the length of such conduit sections is short, or if neglecting heat transfer in such conduit sections does not adversely affect the medical procedure. Absent.

Alternatively, if it is possible to change the flow rate of liquid into the body depending on the treatment of the subject,
In addition to or instead of controlling the temperature of the liquid by the temperature control unit described above, the residence time in the flow path of the liquid is changed by changing the injection flow rate of the liquid,
As a result, it is also possible to control the temperature by utilizing the change in the amount of heat radiation or the amount of heat absorption. Usually, when the flow rate is increased, the influence from the environment is reduced, and ΔTa tends to be reduced. Since the flow rate cannot be largely changed in many cases, the mode in which the flow rate is changed is generally particularly preferably applicable to slightly changing the injection liquid temperature (T1). Such a change in flow rate can be combined with the system of any aspect of the present invention.

In another preferred embodiment, the heat transfer during the flow of the liquid exiting the temperature control unit and flowing through the flow path until it is injected into the blood vessel, that is, the temperature control in anticipation of a change in the thermal state of the liquid. Control the unit. That is, it is a kind of feed forward control.

That is, in this embodiment of the present invention, the unit outlet temperature (T2) is set to the predetermined temperature (T
0), the temperature of the liquid at the time of injection into the blood vessel (injection liquid temperature T1) is expected to be lower than the predetermined temperature (T0) (for example, when the predetermined temperature is room temperature). Higher, when heat is released from the liquid to the environment), the amount of heat that will be released when passing through the conduit as a flow path from the temperature control unit to the blood vessel is predicted, and the heat amount is calculated by the temperature control unit. Add extra in advance. Conversely, when the temperature adjusting unit is operated so that the unit outlet temperature (T2) becomes the predetermined temperature (T0), for some reason, it is expected that the temperature of the liquid to be injected into the blood vessel becomes higher than the predetermined temperature (for example, the predetermined temperature). Is below room temperature and the liquid absorbs heat from the environment), the cooling in the temperature control unit is anticipated by estimating the amount of heat that will be absorbed when passing through the conduit as a flow path from the temperature control unit to the blood vessel. Strengthen.

The anticipation of such heat transfer depends on a given liquid,
And pre-selecting the dimensions (length, diameter, etc.) and material of the conduit from the temperature control unit outlet to the liquid injection point,
These are prepared and the outlet temperature of the temperature control unit (T
2) Various data of the room temperature (T3) and the flow rate (v) of the liquid in the room in which the system is placed are variously changed, and data on how the injection liquid temperature (T1) is thereby changed are experimentally obtained in advance. .

For example, v = 300 cc / min, T2 =
When the parameters are set to 20 ° C. and T3 = 25 ° C., T1 is measured when a predetermined liquid flows through a predetermined conduit. Next, T1 is measured under the same conditions except that T3 = 30 ° C. Such measurement is performed for each parameter to obtain experimental data, and a matrix of parameters (T2 vs. (T1, T3, v))
(Or table).

Using this matrix, T2 under any parameter conditions is expected. That is, T3,
If v is known, T2 when it is desired to set T1 = T0 can be obtained as the set temperature of the liquid in the temperature control unit. If the measurement is performed for the case where the liquid is changed to another type, the set temperature of the liquid of the temperature control unit can be similarly predicted for the case of another liquid. The same applies to the change of the conduit. Thus, in this case, the system of the present invention has a third sensor that measures room temperature (T3).

From the data obtained experimentally, instead of a matrix or a table, the correlation between T2 and (T1, T3, v) is expressed by a relational expression: T2 = Fn (T1, T3, v)
(Where Fn means a function). Such an expression can be obtained by an appropriate approximation calculation method. The set temperature of the temperature control unit is obtained by substituting the measured room temperature, the selected liquid injection flow rate v, and T1 = T0 into a relational expression, and obtaining the unit outlet temperature (T
2).

That is, in this aspect, the system of the present invention comprises a second sensor for measuring the temperature of the liquid exiting the temperature control unit (unit outlet temperature T2) and a second sensor for measuring the room temperature (T3) in which the system is located. The temperature control of the liquid in the temperature control unit further including three sensors and considering heat transfer between the liquid and the surrounding environment includes: (1) transferring the liquid from the temperature control unit through a predetermined conduit to the blood vessel ( In the case of injecting into the body, the effects of the unit outlet temperature (T2), room temperature (T3) and liquid injection flow rate (v) on the injection liquid temperature (T1) are experimentally obtained as data in advance (or From the data, T2 = Fn (T1, T3, v) (where Fn represents a function) is obtained in advance as a relational expression), and (2) a predetermined liquid injection flow rate ( At the time of actually injecting the liquid into a blood vessel (or the body) in ()), the room temperature (T3) is measured, and based on the result, the liquid injection temperature (T1) is required to reach the predetermined temperature (T0). Unit outlet temperature (T
2) is estimated from the data obtained in advance (or T2 is obtained by substituting v, T1 = T0 and T3 into the relational expression), and (3) the temperature control unit is operated and the unit outlet temperature (T2) Performs the temperature control of the liquid in the temperature control unit so that the T2 becomes the estimated T2,
(4) Thereafter, the operation is performed by operating the pump to start the operation of the system.

In another embodiment, the temperature control unit outlet temperature T2 is predicted by a model formula instead of the above-mentioned matrix for the prediction of heat transfer. In order to express the change in the thermal state as a result of the heat transfer of the liquid flowing through the conduit, taking into account the heat transfer to the surroundings, various heat transfer model formulas are conceivable. Any formula may be used as long as it does not adversely affect the system. Specifically, for example, a model formula (for example, T
2 = fn (T1, T3, v), where fn represents a function.

As described above, the data (based on the data,
Matrix or table), relations or model equations may be used when the conditions of heat transfer between the liquid and the environment change, for example, the type of liquid to be injected (including solvent, solute and its concentration etc.) and / or the liquid to be injected If the hardware (such as the type (material, length, wall thickness, etc.) of the conduit from the temperature control unit to the injection point) that supplies the heat changes, the heat transfer coefficient changes, and such changed conditions Must be obtained in advance. For example, when the viscosity of the liquid changes, the thermal conductivity changes, and finally the heat transfer coefficient may change.

In the feed-forward control mode for estimating the above-mentioned heat transfer, the unit outlet temperature (T2) for keeping the injection liquid temperature (T1) at the predetermined temperature (T0) in consideration of various parameters. This is expected, and should theoretically be T1 = T0, but may not always be as expected, and in that case, it is actually possible. In such a case, also in these embodiments, the first sensor is provided and the injection liquid temperature (T1) is actually measured, and the result is compared with a predetermined temperature (T0), that is, ΔTa is obtained. According to the result, it is preferable to control the unit outlet temperature (T2) as in the case of the feedback control described above. Thereafter, it is more preferable to repeatedly or intermittently determine ΔTa and control the unit outlet temperature (T2) according to the value.

In any aspect of the present invention, in the system of the present invention, the temperature of the liquid to be injected (T1) is preferably measured by providing a first sensor at or near the liquid injection point. Therefore, if the liquid to be injected is to be injected into a blood vessel near the body surface, it is preferable to measure the temperature of the liquid at the point closest to the body (that is, closest to the body). For example, the temperature of the infused liquid is preferably measured just before the liquid enters the body. Of course, it is also preferable to measure at or near the tip of the conduit inserted into the blood vessel. When the liquid injection is actually performed in a deep part of the blood vessel, the injection liquid temperature (T
It is preferable to measure 1). The second sensor is provided at the outlet of the temperature control unit, and the third sensor is provided in the room where the system is located, preferably in a portion near the conduit from the temperature control unit to the blood vessel.

In any embodiment of the system of the present invention, the liquid is transported via a conduit. The conduit may be any suitable one that does not adversely affect the infused liquid, and thus does not adversely affect the medical procedure, and is usually a suitable conduit (eg, silicone tubing, polyvinyl chloride tubing, etc.). With respect to the part into which the liquid is injected into the blood vessel or body, it is particularly preferred that the conduit is in the form of a catheter (eg a balloon catheter), which is used to measure the temperature of the liquid passing through it. Advantageously, it is preferred that the sensor for measuring the temperature be accessible to the inner wall of the conduit by means of an exposed or thin layer.

The liquid to be injected is sent from the liquid container via the temperature control unit. The liquid container may be in any suitable form, for example a plastic container or a plastic bag in which the liquid is enclosed, or a tank holding the liquid removed from such a container. Good. The liquid is sent from such a liquid container to the temperature control unit and then injected, but the pump for transporting the liquid in this way may be any suitable pump, for example a roller pump or a centrifugal pump. May be. In any of the systems of the present invention, any conduit that needs to deliver liquid at a predetermined flow rate may be provided with a flow meter and / or valve, which cooperates with the pump to provide a predetermined flow rate (and thus metering). Derived or injected). The location of the pump may be either upstream or downstream of the temperature control unit, but is usually located upstream.

In any of the embodiments of the system of the present invention, as will be described later, the injection of the liquid is preferably carried out through a catheter constituting the final part of the conduit. In a particularly preferred embodiment, the liquid is injected. By placing a thermistor at or near the tip of both sides of the catheter that injects (i.e., distal) and measuring the infused liquid temperature to the extent possible by inserting the catheter into the body,
The temperature accuracy of the liquid to be injected is improved. The sensor for measuring the temperature may be any suitable sensor capable of measuring the temperature, but generally may be a thermistor or a thermocouple.

The liquid used in the system of the present invention can be cooled or heated in a suitable temperature control unit,
There is no particular limitation as long as it can be injected into the body via a conduit or catheter for the purpose of a predetermined medical procedure. For example, such a liquid can be exemplified by an aqueous solution containing nutrients and electrolytes, and may be, for example, Ringer's solution, Ringer's lactate, Ringer's solution containing low molecular dextrin (eg, containing 5%), but is not limited thereto. . In addition, so-called replacement fluids (solutions for dilution, supplementation, addition or replacement), infusions, and so-called drug solutions are also included in the liquid supplied by the system of the present invention.

Although the present invention provides a liquid supply system as described above, the term "system" refers to various components (such as a temperature control unit, a pump,
Sensors, conduits, liquid containers, oxygenator, etc.) are used in the sense that they do not necessarily have to constitute a single device, but some or all of these elements may be together Embodiments constituting the above device are also included in the concept of the present invention. Accordingly, the present invention relates to a temperature control unit, a pump,
There is also provided a liquid supply for a medical procedure comprising a sensor and a conduit, taking into account the heat transfer of the injected liquid,
These elements supply liquid to a blood vessel (or body) at a predetermined temperature (T0). In the present invention, as various elements constituting the system (or the apparatus), those commonly used in various medical treatments can be basically used.

[0043]

DETAILED DESCRIPTION OF THE INVENTION "Separation temperature control" as an example of a medical procedure that can incorporate the system of the present invention.
The term is a method of maintaining an object, which is a part of the body, at a predetermined temperature, including "separated cooling" and "separated warming". The term "separation cooling method" is a method used in the medical field, particularly in the field of neurosurgery, and specifically, selects a part of a target body, for example, an organ such as the brain, and selects the target. Means a method of locally cooling a part.

The separation cooling method is used, for example, when bleeding is a concern, such as when performing surgery on a local part (for example, the head), or when the activity of a biological function is temporarily reduced locally, during which time. This is a local cooling method used when performing various treatments or treatments. While the “separation cooling method” cools the object, the “separation heating method” differs from the “separation cooling method” only in that the object is heated, and in the medical field, for example, cancer, frostbite In order to carry out such treatment, a “separation heating method” in which a target body part, for example, a cancer-containing organ is selected and the site is locally heated can be applied.

The implementation of the "separation temperature control method" incorporating the system of the present invention is performed at a certain point in an artery which directly or indirectly communicates with the object to be temperature-controlled. A fluid is injected into a blood vessel, and blood diluted with replacement fluid is extracted from the body through a blood vessel from a point of a vein communicating directly or indirectly with the site, and then the diluted blood is concentrated by concentrating the diluted blood. Blood that is close to the state, preferably substantially equivalent to the blood before dilution, is collected, and the collected blood is temperature-controlled (for example, to around the body temperature) and then directly or indirectly communicates with the vein. Veins closer to the heart (so-called,
At the side of the heart) and back into the body via blood vessels. The system of the present invention can be incorporated to inject a rehydration fluid, adjusted to a predetermined temperature, at a location in an artery into a blood vessel.

Accordingly, one aspect of the system of the present invention is an extracorporeal circulation device (or system) for use in performing a separation cooling method, wherein the device is used to selectively cool an object to a predetermined temperature. It can be incorporated into what you do. In another aspect, the present invention can be incorporated into an extracorporeal circulation device (or system) used when performing a separate heating method of heating to a predetermined temperature instead of cooling. Such an extracorporeal circulation device (or system) can be used, for example, when heating a subject to a high temperature at which normal cells are unaffected but cancer cells can die. Specifically, cancer cells have been found to die at high temperatures, eg, about 42-43 ° C., and provide a predetermined high temperature liquid to heat only those subjects where such cancer cells are present. It is particularly convenient in some cases. Furthermore, after the completion of such heating, it is necessary to supply a lower temperature liquid to cool the object in order to return the temperature to the original body temperature, and at this time, using the system of the present invention, The lower temperature liquid can be injected with further improved temperature accuracy, and as a result, the body temperature can be quickly returned to the original body temperature, and the burden on the patient is reduced.

In one preferred embodiment, the system of the present invention further comprises an oxygenator. The artificial lung may be any device as long as it has a function of increasing the amount of oxygen dissolved in a liquid such as blood, diluted blood or replacement fluid, that is, has a so-called oxygenation function. Membrane and bubble types can be used. Having an oxygenator in this manner may be advantageous for certain medical procedures because the fluid to be injected is oxygenated.

Hereinafter, the apparatus of the present invention will be described in more detail with reference to the accompanying drawings. FIG. 1 is a schematic diagram (flow sheet) schematically showing the configuration of the system of the present invention. The system of the present invention shown in FIG. 1 includes a liquid (1) at a predetermined temperature (T0).
02) into the blood vessel (104) (or the body (106)), a temperature control unit (108) for performing temperature control of a liquid to be injected into the blood vessel;
And a pump (110) for transporting the liquid to the blood vessel via the temperature control unit. Liquid is held in a liquid container (112) from which blood vessels (10
Until 4), the liquid is delivered via a suitable conduit (114) (eg, silicone tubing) and catheter (116).

In the illustrated embodiment, the temperature control unit (1
08) may be a water bath using water as a heat medium, and a conduit (120) through which liquid passes in the bath;
The arrangement is preferably in a spiral form. The heating medium is maintained at the set temperature of the temperature control unit, and the liquid is heated or cooled to substantially the set temperature while the liquid passes through the conduit (120). In one embodiment, the infused liquid temperature (T1) is measured by using a balloon catheter (11).
The temperature at the unit outlet (T2) is measured by the first sensor (130) arranged at the tip of 6).
32). The measured unit exit temperature (T2) is the temperature at which the liquid exits the liquid unit controlled by the temperature control unit (108). When the temperature control unit (108) is a water bath type heat exchanger, the temperature (T2 ′) measured by the temperature sensor (134) for measuring the temperature of the heat medium of the temperature control unit is the temperature control unit. Is the set temperature of
This is the temperature upon exiting the liquid unit controlled by the temperature control unit (108). Accordingly, the temperature (T) measured by the temperature sensor (134)
2 ') can be used instead of the unit outlet temperature (T2) by the second sensor (132).

In the system of the present invention, the temperature of the liquid in the temperature control unit (108) is controlled by the liquid and the surrounding environment until the liquid exiting the temperature control unit (108) is injected into the blood vessel. Heat transfer between the outlet of the temperature control unit (122) and the point at which the liquid is injected into the blood vessel (124) (i.e. the point where the catheter was inserted into the blood vessel) and the liquid at the catheter and their Consider heat transfer to and from the surroundings. As shown in the figure, when a catheter with a balloon is inserted deep inside a blood vessel, the blood vessel around the catheter is also an environment. In this case, the injection liquid temperature (T1) at or near the tip of the catheter is measured. By taking such heat transfer into account, it is possible to bring the temperature of the liquid injected from the system of the present invention closer to a predetermined value with improved accuracy.

When it is sufficient to control the temperature of the infused liquid at the point where the liquid enters the body (ie, the point of connection between the catheter and the body), the liquid is injected into the body through the outlet (122) of the temperature control unit. (12
6) Consider the heat transfer between the fluid in the conduit and catheter to their surroundings (ie the point of connection between the catheter and the body) and their surroundings. In that case, it is not necessary to measure the infused liquid temperature (T1) at or near the tip of the catheter as described above, and the first sensor (136) at or near the connection point between the catheter and the body uses the infused liquid temperature (T1). ') Should be measured. In such a system, in one aspect, heat transfer considerations take into account the difference between T1 or T1 ′ and T0.

In another embodiment, as shown, the temperature (T3) of the environment in which the system is located, for example, the room temperature, is measured by a third sensor (138) as shown in FIG. Using the predetermined temperature T0 (= T1) and the injection flow rate v, the data or matrix previously obtained experimentally as described above, or the above formula (I)
The temperature at the unit outlet (T2) is determined based on the above formula, and the temperature control unit is controlled so that the liquid exits the temperature control unit at this temperature.

The above-described system of the present invention is schematically shown in FIG.
Can be incorporated into an extracorporeal circulation device (or system) used to bring an organ (24) to be subjected to medical treatment to a predetermined temperature (T0). This extracorporeal circulation device has the liquid supply system of the present invention used as a rehydration infusion unit (A). The replenisher as a liquid in the system of the present invention is supplied from a rehydration container (8) to a replenisher in the body (17). Pump (1) for injecting at a predetermined temperature (T0) (with a function of measuring and adjusting the amount of liquid to be sent), a temperature control unit (3), and a rehydration drip chamber (9) for replenishing fluid to be injected into the body Temperature (T1 ′) is the first
It is measured by an infusion fluid temperature sensor (4) as a sensor. In the illustrated embodiment, the unit outlet temperature (T
2) is the temperature (T) of the heat medium of the bath of the temperature control unit (3).
2 ').

The illustrated extracorporeal circulation device (or system) also has a blood concentrating unit (B), which derives the diluted blood from the body (17), that is, removes the blood and ends the blood. Specifically, a blood pump (5) for returning the collected concentrated blood to the body (17), an anticoagulant injector such as heparin or Fusan (18), a blood drip chamber (1)
2), for example, a filtration filter (or dialyzer)
Blood concentrator (13) and dewatering tank (1
4) and optionally a water removal pump (7), and the derived temperature (T4) of the diluted blood is measured by a diluted blood temperature sensor (20). The blood concentrating unit is provided with a replenisher tank (22) for filling the replenisher in conduits and elements in the device at the start of operation of the device.

Further, the illustrated extracorporeal circulation device (or system) has a blood infusion unit (C), which includes a blood return drip chamber (16) and a heat exchanger for regulating the temperature of the concentrated blood. (6).
In order to control the temperature of the concentrated blood, the heat exchanger has a temperature sensor (50). These units or their constituent elements are connected by appropriate conduits (shown by thick solid lines in the drawings), and the necessary connection between each unit and the body (17) is made by a catheter (1).
0, 11 and 15).

In the infusion rehydration unit, the rehydration pump (1) is usually operated at 10 to 800 ml / min, preferably at 50 ml / min.
~ 500ml / min, more preferably 100 ~ 400ml
The replacement fluid can be quantitatively injected into the body (17) within the range of / minute. The practical flow rate of the pump will be selected as needed from such ranges depending on the purpose of the treatment of the subject. As such a pump capable of quantitatively sending the replacement fluid (and thus capable of metering and injecting), a roller pump often used for sending blood can be exemplified. In order to quickly adjust the temperature of the object, it is preferable that the flow rate is relatively large, for example, it is more preferable to apply a flow rate of 100 to 400 ml / min. Instead of a roller pump, it is also possible to use a centrifugal pump,
In this case, it is preferable to use in combination with a suitable flow control means, for example, a valve.

When the injection amount of the replacement fluid can be controlled by the rotation speed of the motor of the replacement fluid pump (1), it is not always necessary to provide a separate flow meter, but a flow meter is provided in the replacement fluid line to check the injection amount of the replacement fluid. May be. The flow meter may be, for example, an electromagnetic flow meter. Further, it is preferable that the pump has a control function (for example, a function of changing the rotation speed of the pump motor or changing the pressure loss of the conduit) so that the flow rate becomes the predetermined amount when the flow rate is not the predetermined amount. The flow meter may be omitted if the replenishment pump (1) is quantitatively secured, and in this sense, the apparatus of the illustrated embodiment does not include a flow meter in the conduit. Such features of the replacement fluid pump (1) also apply to the pump used in the liquid supply system of the present invention.

Container (8) for holding replacement fluid and pump (1)
Between them, a drain-out detector (44) and a drip chamber (56) are provided. The rehydration infusion unit may have, in addition to the elements described above, a separate drip chamber (9, with pressure gauge P) for defoaming and separating out any entrained air bubbles. it can.
Similar drip chambers (12 and 16) are provided in the blood concentration unit and the blood infusion unit.
A filter (40) for removing impurities in the replacement fluid
A bubble detector (42) for confirming the presence of bubbles in the replacement fluid
May be provided. As also shown in FIG. 1, various such elements can be used in the system of the present invention.

In the embodiment shown in FIG. 2, the pump (5)
Before the operation, the element for measuring the blood pressure of the derived diluted blood (4)
8), and a drip chamber (52) and a clamp (5) are provided downstream of the rehydration tank (22).
4) is provided. Although the description above with reference to FIG. 2 is for injecting replacement fluid, similar features apply to injecting other fluids as long as the medical procedure is not adversely affected.

The system of the present invention shown in FIG. 1 can be applied, for example, when a liquid is injected into a blood vessel as follows.

(Case 1) First, operating conditions such as the flow rate of the injected liquid (v) and the predetermined temperature (T0) of the injected liquid are determined according to the treatment to be performed. Next, the temperature control unit (108) is operated, and the set temperature of the liquid to be controlled is set to, for example, a predetermined temperature (T0) to operate the temperature control unit (108). In this case, heat transfer with the environment,
That is, the set temperature of the temperature control unit (108) may be slightly shifted from T0 in consideration of heat absorption or heat dissipation in advance.

Each catheter is inserted into the body and a pump (1) is inserted.
10) is operated to supply the liquid from the liquid container (112) to the temperature control unit (108), and to control the temperature of the liquid to the set temperature (T2) or a temperature close to the set temperature (T2), and then inject the liquid into the body to perform system The operation is started to supply the liquid.

Next, the first sensor (130 or 13)
6), the injection liquid temperature (T1 or T1 ′) is measured, and a temperature difference ΔTa (= T0−T1) from a predetermined temperature (T0) is measured.
Or T0−T1 ′), and the temperature control unit (10
8) Consider the heat transfer of the liquid from exiting to injection.

If ΔTa> 0, the injection liquid temperature has not reached the predetermined temperature (the heating amount in the temperature control unit is too small and / or the heat radiation is too large), so that the temperature control unit outlet temperature (T2 The temperature control unit is controlled automatically or manually so that the temperature rises. Conversely, if ΔTa <0, the injection liquid temperature is too high (the heating amount in the temperature control unit is too large and / or the heat radiation is small or heat is absorbed), so the temperature control unit outlet The temperature control unit is controlled (automatically or manually) so that the temperature (T2) decreases.

Thereafter, the injection liquid temperature (T1 or T1)
1 ′) is measured again, and ΔTa is obtained in the same manner. According to the result, the unit outlet temperature (T2), that is, the set temperature of the temperature control unit (108) is changed, and the temperature of the liquid to be injected is controlled. .

The first calculation of ΔTa and the second calculation of ΔT
The time interval between the calculation of “a” is not particularly limited, but if it is too long, the injection liquid temperature (T1) is likely to cause hunting. Of course, the injection liquid temperature (T1) is continuously measured, and the temperature difference Δ
The set temperature of the temperature control unit (108) can also be considered in consideration of the nature of Ta (absolute value of difference, rate of change of difference over time, etc.). Such a measurement and the change of the set temperature of the temperature control unit (108) are repeated during the operation of the system to bring the temperature of the liquid to be injected (T1) close to the predetermined temperature (T0) of the target site and maintain it. Note that substantially ΔT
If a = 0, the temperature control unit (10
There is no need to change the settings in 8).

(Case 2) In this case, the system to be used is determined first, so that the type and length of the conduit from the temperature control unit (108) to the injection point are known. Accordingly, the length (l) of the conduit from the outlet of the temperature control unit to the liquid injection point, the heat transfer coefficient (α) of the conduit material, the total surface area of the conduit (A), and the volume of the liquid in the conduit (V) are determined in advance. I know. Further, the type of liquid to be injected is selected according to a predetermined medical procedure. Under these conditions, the unit outlet temperature (T2), room temperature (T
3) When the injection flow rate (v) changes variously, how the injection liquid temperature (T1) is affected is determined in advance as data, a relational expression (T2 = Fn (T1, T3, v)) or a matrix table. Get it.

In actually applying a given medical procedure, the infused liquid temperature (T0) and the infused liquid flow (v) are selected. Next, the room temperature at which the system is located is measured by the third sensor (138). Now, a predetermined temperature (T
0) is determined, the injection liquid temperature (T1) is T0
Need to be

Therefore, from the data obtained in advance, T1 is T0
T2 in the case of (known) is obtained for known v and T3. When the relational expression is used, T2 is obtained by substituting the known T0 into T1 together with the known v and T3.

Next, the temperature control unit (108) is operated to control the temperature of the liquid so that the unit outlet temperature becomes the calculated T2, and then the pump (110)
To operate the system to inject liquid. More preferably, thereafter, the injection liquid temperature (T1) is measured by the first sensor, the temperature difference from the predetermined temperature (T0) is obtained, and the same control as in Case 1 is performed.

(Case 3) When a predetermined liquid and a predetermined conduit are used, for example, as described above, the heat transfer of the liquid is determined by parameters: injection liquid temperature (T1), unit outlet temperature (T2), and room temperature (T3). And modeled by the injected liquid flow rate (v) (therefore, the model equation: T2 =
When fn (T1, T3, v) is obtained (fn represents a function), the room temperature (T3) is first measured by the third sensor, and the predetermined temperature (T0) selected in advance is obtained. As T1, a unit outlet temperature (T2) is obtained from a preselected injection liquid flow rate (v).

Next, the system is operated at the unit outlet temperature (T2) from which the set temperature of the temperature control unit is obtained, and then the pump is operated to operate the system. More preferably, thereafter, the injection liquid temperature (T1) is measured by the first sensor, the temperature difference from the predetermined temperature (T0) is obtained, and the same control as in Case 1 is performed.

In using the system of the present invention, the liquid is temperature-controlled by the temperature control unit (108) after passing from the container (112) through the liquid feed pump (110), and then subjected to, for example, a separation temperature control method. Into the body (106) via a catheter (116) into a blood vessel, usually an artery. In this case, a catheter is inserted into a blood vessel (artery) reaching the target (140) to which the separation temperature control method is applied, but the position where the catheter is inserted into the body is not necessarily limited to the vicinity of the target (140). For example, a catheter is inserted percutaneously from the femoral artery to the brain like the so-called Seldinger's method,
A method of injecting replacement fluid can also be adopted.

In such a case, the first sensor (130)
Is preferably located at or near the insertion tip of the catheter (116), rather than outside the body, so that the infusion is closer to the site of interest (ie, distal to the system operator). It is possible to measure the temperature (T1) of the liquid at the point of time. Therefore,
By arranging the temperature sensor near the insertion end of the cartel, the accuracy of temperature control of the injected liquid is further improved, and as a result, for example, an efficient separation temperature control method can be applied.

In one preferred embodiment, the system of the present invention further comprises an oxygenator for oxygenating fluids such as diluted blood, replacement fluid, autologous blood and / or transfusion. For example, in the embodiment shown in FIG. 3, after the liquid (102) to be injected into the body exits the temperature control unit (108), the artificial lung (150)
After injecting into the body. Except for the configuration shown, the configuration may be substantially the same as that of FIG. 1 or FIG. In another aspect, an oxygenator may be provided upstream of the temperature control unit (108).

By using the system of the present invention in any of the embodiments described above, a liquid can be injected into the body at a predetermined temperature, so that, for example, the subject to which the separation temperature control method is applied can be subjected to a desired method. It is possible to maintain the temperature condition with improved accuracy. In particular, the injection liquid temperature (T
When the measurement point 1) is performed close to the target, that is, in the vicinity of the body, the accuracy is further improved. Further, when a temperature sensor is arranged near the distal end of a catheter to be inserted into a blood vessel, the accuracy becomes remarkable. As described below, for example, the medical treatment can be efficiently performed by combining the system of the present invention with the separation temperature control method.

For example, the system of the present invention can be incorporated when applying a separate temperature control for all surgical procedures. For example, by cooling the affected area in the brain, chest, abdomen, limbs, etc. to a predetermined temperature with replacement fluid accurately, the activity of organs etc. is reduced, the progression of damage is prevented, and a low blood pressure state is formed. At the same time as safety is improved, not only the amount of heparin but also the amount of blood transfusion can be reduced, so that surgery without the risk of infection can be performed.

Further, the system of the present invention can be incorporated as part of a method for managing the condition of a patient as well as at the time of surgery, particularly, a method for managing a low activity state, and a separation temperature control method can be applied as a separation cooling method. That is, by combining the system of the present invention, the diseased part is accurately maintained at a desired temperature under the diluted blood condition (this content includes body temperature (normal temperature) maintenance), thereby delaying the progress of the disease, or Can be blocked.

For example, one wants to cool a part of the body to a certain extent, for example, to a temperature in the range of about 34 to 15 ° C., preferably quickly, but does not want other parts to be at a not so low temperature, for example, 28 ° C. or less. In such a case, it is possible to cool only such a part of the body quickly and accurately by combining the system of the present invention. For example, prior to treating a bruise to the brain, one may want to cool only the brain rapidly to delay swelling of the brain, but not other parts.

In particular, when incorporating the system of the present invention,
Because only one part of the body is cooled and the other part is not so cooled, by adjusting the temperature and infusion volume of rehydration fluid, only a part of the body is kept at a very low temperature while keeping the whole body at a relatively high temperature. Can be maintained accurately, which means that it is possible to rapidly cool only the brain when treating a cerebral contusion caused by a traffic accident, etc. It is valid. Also, when incorporating the system of the present invention, only a part of the body is cooled at a more controlled temperature and the other part is not so cooled, so that no side effects occur, and a part of the body is kept at a low temperature for a long time. it can.

The system of the present invention can be incorporated in a device used for state management as described above, that is, a state management device. As used herein, condition management refers to maintaining a local or whole body of a patient at a predetermined temperature, for example, by placing the patient in a low-activity state at a low temperature, or improving a hypothermic state due to hypothermia or the like under heating. It is used to mean that the progression of the disease state is controlled to be slowed or prevented by maintaining the condition under which the malignant cells are killed. In the latter condition management, in particular, from the viewpoint of protection of normal cells, it is very important to maintain the temperature of the target with high accuracy (especially, it is necessary to avoid an excessively high temperature). The system of the present invention, which can maintain the temperature at a predetermined temperature, is very useful.

The liquids that can be injected by the system of the present invention include, for example, anticancer agents, angiogenesis inhibitors, photosensitizers (PDT), contrast agents and / or nutrients in addition to the various liquids described above. Fluid, transurethral perfusate, organ perfusate, etc. are included. When a large amount of heating or cooling of the liquid needs to be injected by the system of the present invention, a high-capacity heating device or cooling device is arranged upstream of the temperature control unit to pre-heat or cool the liquid. Cooling may be preferred.

[Brief description of the drawings]

FIG. 1 is a schematic diagram schematically showing a flow sheet of the system of the present invention.

FIG. 2 is a schematic diagram schematically showing a flow sheet for implementing a separation temperature control method incorporating the system of the present invention.

FIG. 3 is a schematic diagram schematically showing a flow sheet of the system of the present invention having an artificial lung.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Rehydration pump, 3 ... Heat exchanger 4, Infusion rehydration temperature sensor, 5 ... Derivation pump, 6 ... Heat exchanger, 7 ... Water removal pump, 8 ... Rehydration container, 9 ... Drip chamber, 10,
11 catheter, 12 drip chamber, 13
... blood concentration element, 14 ... water removal tank, 15 ... catheter, 17 ... body, 18 ... heparin injector, 19 ... infusion
Water removal controller mechanism, 20: diluted blood temperature sensor, 24: target, 100: liquid supply system, 102:
Liquid, 104: blood vessel, 106: body, 108: temperature control unit, 110: pump, 112: liquid container, 114
... conduit, 116 ... catheter, 120 ... temperature control unit internal conduit, 122 ... unit outlet, 124 ... injection point (intravascular), 126 ... body injection point, 130 ... first (temperature) sensor, 132 ... second (temperature) ) Sensor, 134
... temperature sensors of the temperature control unit, 136 ... first temperature sensor, 138 ... third (temperature) sensor, 140 ... subject (or organ), 150 ... artificial lung.

Continued on the front page (72) Inventor Tetsuya Miyatake 498-1 Shizuya, Haibara-cho, Haibara-gun, Shizuoka Prefecture Nikkiso Co., Ltd. HH15 JJ02 JJ03 JJ04 JJ08 JJ13 JJ15 JJ16 JJ19 JJ28 KK25 KK27

Claims (14)

[Claims] 1. A system for medical treatment for continuously supplying a predetermined liquid to a body at a predetermined temperature (T0), comprising: a temperature control unit for controlling a temperature of a liquid to be injected into the body; and a temperature control. Comprising a pump for injecting liquid into the body via the unit and the conduit, wherein the temperature control of the liquid in the temperature control unit comprises:
A liquid supply system that takes into account heat transfer between the liquid and its surrounding environment until the liquid exiting the temperature control unit is subsequently injected into the body. 2. A first sensor for measuring the temperature of the liquid at the time of injection into the body (injection liquid temperature T1), and the temperature of the liquid exiting the temperature control unit (unit outlet temperature T1).
2) a second sensor for measuring the temperature of the liquid, wherein the temperature control of the liquid in the temperature control unit in consideration of heat transfer between the liquid and the surrounding environment includes: (1) temperature control at an initial set temperature; The unit and the pump are operated to start the operation of the system. (2) Injected liquid temperature (T1) is measured. (3) Injected liquid temperature (T0) measured as a predetermined temperature (T0)
The temperature difference ΔTa (= T0−T1) from (1) is obtained. (A) If ΔTa> 0, the unit outlet temperature (T2) is increased. (B) If ΔTa <0, the unit outlet temperature (T2) 2. The system according to claim 1, wherein the system is implemented to reduce (c) or to maintain the unit outlet temperature (T2) when ΔTa = 0. 3. After performing temperature control of the liquid in the temperature control unit taking into account heat transfer between the liquid and the surrounding environment, steps (2) and (3) are repeated during operation of the system. Item 3. The system according to Item 2. 4. A second sensor for measuring the temperature of the liquid exiting the temperature control unit (unit outlet temperature T2) and a third sensor for measuring the room temperature (T3) in which the system is located.
The temperature control of the liquid in the temperature control unit taking into account the heat transfer between the liquid and the surrounding environment further includes a sensor. (1) Injecting the liquid into the body from the temperature control unit through a predetermined conduit The unit outlet temperature (T
2) The effects of the room temperature (T3) and the liquid injection flow rate (v) on the injection liquid temperature (T1) are experimentally obtained in advance as data (or T2 = Fn from the data).
(T1, T3, v) (where Fn represents a function) is obtained in advance as a relational expression). (2) When the liquid is actually injected into the body at a predetermined liquid injection flow rate (v), The room temperature (T3) is measured, and based on the result, the liquid injection temperature (T1) is set to the predetermined temperature (T3).
0), the unit outlet temperature (T2) required to become
Estimate from data obtained in advance (or v,
T1 = T0 and T3 are substituted to obtain T2), (3) The temperature control unit is operated, and the liquid temperature control in the temperature control unit is performed so that the unit outlet temperature (T2) becomes the estimated T2. (4) The system according to claim 1, wherein the system is operated by operating a pump to start operation of the system. 5. The liquid is injected into the body via a catheter which constitutes the last part of the conduit, and a first sensor for measuring the temperature of the liquid at the time of injection into the body (injected liquid temperature T1) comprises: The system according to any of the preceding claims, located at or near the distal tip. 6. The temperature control unit according to claim 1, wherein the temperature control unit is an indirect heat exchanger capable of heating and cooling the liquid, heating or cooling, and achieving a predetermined unit outlet temperature (T2). System. 7. The system according to claim 1, wherein the liquid to be injected is injected into the body via an artificial lung located upstream or downstream of the temperature control unit. 8. The system according to claim 7, further comprising a drip chamber for blowing oxygen instead of the oxygenator. 9. The system according to claim 1, wherein the liquid is injected into a blood vessel. 10. A liquid to be injected into a body or a blood vessel is a replacement fluid, which is temperature-controlled to a predetermined temperature T0 in a range of 1 ° C. to 36.5 ° C., and is used when performing a separation cooling method. 10. The system according to any one of items 9. 11. A liquid to be injected into a body or a blood vessel is a replacement fluid, which is temperature-controlled to a predetermined temperature T0 in a range of 36.5 to 45 ° C., and is used when performing a separation heating method. 10. The system according to any one of items 9. 12. The system according to claim 1, which is incorporated into an extracorporeal circulation system for use in surgery. 13. The system according to claim 1, which is incorporated into an extracorporeal circulation system for use in managing the condition of a body part. 14. An extracorporeal circulation system comprising the system according to claim 1.