JPH0741067B2 - Treatment device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial field of use] The present invention relates to a therapeutic device for realizing a new therapeutic action.

[Prior Art] Conventional drug administration methods include oral, transdermal, transmucosal, inhalation,
There are methods such as intravascular administration (arterial injection and intravenous injection). Above all,
Intravascular administration is the most reliable method because of pharmacodynamic problems such as stable absorption of the drug or maintenance of effective blood concentration, and intravascular administration is considered useful for patients who require intensive treatment. However, in terms of side effects and interactions with other drugs, it is not always necessary to increase the blood concentration of the drug, and the systemic dose of the drug should be as low as possible while the local dose should be as high and long as possible. It is desired to shift to time. Therefore, even if it is administered intravascularly, it has a strong medicinal effect, but on the other hand, drugs with significant side effects (such as anticancer drugs and drugs that are too expensive for effective systemic administration (thrombolytics, etc.)) are administered locally in the arteries. Is being carried out. Further, as a procedure for administration of these blood vessels, there is a method of introducing a balloon catheter into the blood vessel. According to this method, since the blood vessel artificially occludes the blood vessel, it is possible to administer an extremely high concentration of drug. .

Oxygen administration is also one of the important treatments. This is to protect the tissue from the risk of hypoxia-induced dysfunction and necrosis and traditionally only the trans-airway method has been implemented. In addition, recently, warm therapy has become popular as one of cancer treatments. For this purpose, methods have been developed such as warming the whole body, warming and compressing a limited area in the diseased area, and inserting a heater into a blood vessel.

[Problems to be Solved by the Invention] However, the intravascular administration, oxygen administration, and the like performed as described above are not yet sufficient, and there are the following problems.

First, in the method of intravascular administration, no matter how much the drug is locally injected, the drug is transported to the tissue bloodstream and immediately spreads throughout the body. Therefore,
It is unrealistic to administer a high concentration of a drug to a diseased site for a long time, and if the drug is forcibly administered and a large amount of the drug is administered, the total dose increases and side effects become a serious problem. Although a method of performing drug administration by occluding the dominant blood vessel to be administered using a balloon catheter is also conceivable, this method causes only necrosis of the tissue under the control, and thus administration can be performed only for a short time.

Next, in the conventional trans-airway oxygen administration method, the inspiratory oxygen concentration and the lung ventilation are increased in order to administer a sufficient oxygen amount. However, administration of oxygen at an excessively high concentration causes damage to lung tissue, and causes oxygen poisoning to the central nervous system and the like under high oxygen partial pressure.

For this reason, the blood flow in the diseased region is limited by some cause, and even if there is a risk of tissue necrosis, extremely high concentration oxygen treatment was impossible. Further, in the case of lung disease or right / left Shunt heart disease, there is a problem that effective oxygen administration itself is difficult.

Further, even in the case of the warm treatment, not only the whole body warm treatment causes a great pain to the patient but also the burden on the circulatory system is large, so that it cannot be performed in a patient having a low cardiac function. Therefore, treatment limited to the diseased part cannot be performed from the outside of the body, and when a heater or the like is inserted into the blood vessel, there is a risk of destroying blood cell components if a sufficient amount of heat is applied to warm the diseased part.

The present invention has been made in view of the above problems, while suppressing extremely side effects of drug and oxygen administration or hyperthermia,
It is an object of the present invention to provide an excellent treatment device that can be efficiently performed regardless of the existence of any underlying disease.

[Means for Solving Problems] Means configured according to the present invention for solving the above problems are as follows.
As shown in FIG. 1, a drug solution supply means M1 for supplying a drug solution to blood based on the blood flow rate.
And temperature control means M2 that controls the blood temperature based on the blood flow rate.
And oxygen supply means M3 that supplies oxygen to the blood based on the blood flow.
A selection means M4 for selecting at least one means from the chemical solution supply means M1, the temperature control means M2 and the oxygen supply means M3; and the selection with respect to the blood flowing at a predetermined flow rate from the inflow part In. After performing a predetermined process based on the predetermined flow rate by the means selected by the means, the outflow portion at the predetermined flow rate
The blood processing means C1B flowing out from Out, and the two tubular members T1 and T2 whose one ends are connected to the inflow portion In and the outflow portion Out of the blood processing means C1B are made into one bundle and are connected to the outflow portion Out. A first opening Op1 is formed at the other end of the first tubular member T2 that is connected to the inflow portion In at a position closer to the outflow portion Out than the first opening Op1 is. A balloon catheter having a second opening Op2 formed in the member T1 and having an expandable balloon B in the middle of the position where the first opening Op1 and the second opening Op2 are formed, and C2B The gist is a treatment device characterized by including:

[Operation] The predetermined processing performed on the blood by the blood processing means C1B in the present invention is control of drug concentration in blood, control of blood oxygen content, control of blood temperature, or the like, or a combination thereof. Based on the judgment of
1. The temperature control means M2 and the oxygen supply means M3 are appropriately selected through the selection means M4. The blood that has been subjected to the above processing is blood that flows in from the inflow portion In. The blood processing means C1B of the present invention that performs a predetermined process on such blood causes the processed blood to flow out from the outflow portion Out while controlling the flow rate.

The balloon catheter according to the present invention has two blood passages T1 and T2. These two blood passages T1, T2
In the blood passage T2 connected to the outflow portion Out of the blood processing means C1B described above, a first opening Op1 for discharging blood is formed on the tip side of the balloon B. The other blood passage T1 has a second opening Op2 formed on the blood treatment means C1B side of the balloon B and is connected to the inflow portion In of the blood treatment means C1B. That is, according to the present invention, in the blood vessel occluded by the balloon B of the balloon catheter C2B, the blood stagnation due to the occlusion is flown into the blood processing means C1B at a predetermined flow rate, and the inflowing blood is treated with the blood processing means. C1B performs the predetermined process based on the predetermined flow rate by the means selected by the selection means M4, and then has the effect of releasing blood to the point where the blood flow after the occlusion is stopped.

Hereinafter, the present invention will be specifically described with reference to examples.

[Embodiment] FIG. 2 is a schematic structural explanatory view of a treatment apparatus main body of an embodiment. A catheter as shown in FIG. 3 is connected to the main body of the treatment apparatus for use.

First, based on FIG. 2, the treatment apparatus body 10 as a blood processing means will be described. The pump Pin in the figure is in communication with the female connector 18a1 serving as an inflow portion, and as described below, blood is sucked from the catheter 20 connected by the connector 18a1 and the male connector 18b2 and introduced into the main body 10. , A pump that does not generate thrombus using a technique such as artificial heart, for example, a pulsation type pump is used.

The drug mixing section 12 mixes a predetermined drug with blood pumped from the pump Pin at a predetermined concentration. For example, the predetermined drug solution stored in the drug tank 12a is discharged toward the Y-shaped communicating pipe portion 13 in order to mix it with blood in a predetermined amount using the drug solution discharge pump Pm1. At this time, the operation amount of the pump Pm1 is precisely corrected and controlled by the electronic control unit 40 according to the suction blood flow amount determined by the operation amount of the pump Pin, so that highly accurate concentration control is achieved. The blood temperature control unit in the next stage (hereinafter referred to as "constant temperature bath") 14 is a unit that heats blood to a temperature of 42 to 43 [° C], and is mainly composed of a constant temperature bath and its temperature is electronically controlled. apparatus
The blood temperature is accurately controlled while being picked up by 40.

Further, the chemical liquid supplied from the chemical liquid tank 12a of the drug mixing unit 12 described above is configured to pass through the oxygen content control unit 16 mainly including the pump Pm2 and the oxygen compressor 16a. The oxygen content control unit 16 controls the oxygen content of the chemical solution to a desired value by exposing the chemical solution between the two pumps Pm1 and Pm2 to high pressure oxygen generated by the oxygen compressor 16a. . That is, as is known as an oxygen dissociation curve, oxyhemoglobin (HbO ₂ )
Saturation vary depending on the oxygen partial pressure of blood (PO _2), PO ₂
The higher the value, the higher the HbO ₂ saturation and the more oxygen can be controlled in the blood. Therefore, here, by precisely controlling PO ₂ , the HbO ₂ saturation of blood to be contacted later is increased and the PO ₂ of blood is set to a desired value. In this way, the chemical solution that has been processed under pressure adjustment is pump Pm1.
Therefore, it comes into contact with the blood discharged toward the above-mentioned Y-shaped communication pipe portion 13 at a desired flow rate and flowed in by the pump Pin.

The oxygen whose pressure has been increased by the oxygen compressor 16a is guided to the oxygen / chemical liquid contact portion 16c via the filter 16b. Here, the oxygen / chemical solution contact portion 16c is provided with filters 16d and 16e at the chemical solution inlet and outlet, respectively, so that oxygen contact in a clean environment is achieved.

Blood that has been appropriately subjected to various treatments as described above is
The Pout conveys the flow rate according to the control signal from the electronic control unit 40, and since the outlet portion is provided with the female connector 18a2 as the outflow portion, it is easily connected to the male connector 18b1 of the catheter 20 described later. It FIG. 3 is an explanatory view of the catheter 20 connected to the female connectors 18a1 and 18a2 of the main body 10. Male connector 18 on catheter 20
b1 and 18b2 can be easily connected to the female connectors 18a2 and 18a1 as in the conventional case. The catheter 20 is formed by bundling three tubes as shown in the figure, and an introductory tube 22 for introducing the blood to be treated as described above into the main body 10, an infusion tube 24 for transferring the treated blood and a balloon 20B are inflated. It consists of a balloon control tube 26 for deflating. Such a catheter 20 is connected to the main body 10 using the connectors 18a1, 18a2, 18b2, 18b1 after the tip having the balloon 20B is inserted until it reaches the dominant blood vessel in the diseased area using a guide wire or the like as in the conventional case. To be done.

As shown in the figure, since the balloon 20B is provided in the vicinity of the distal end portion of the catheter 20, if the balloon 20B is inflated using a syringe after the catheter is mounted as described above, the dominant blood vessel in the diseased area is completely occluded. , Natural blood flow is blocked. However, the tip of the infusion tube 24 that transfers blood that has been subjected to various kinds of treatment as described above protrudes through this balloon 20B, and this projection has a degree of discharging sufficient blood to the tissue under the control blood vessel. A large number of discharge holes 27 of the same size are formed. Therefore, instead of the natural blood flow completely blocked by the balloon 20B, the connector 18a2,1 from the main body 10 is replaced.
Blood that has been artificially subjected to the desired treatment via 8b1 will be injected into the dominant blood vessels in the diseased area. Further, the source of the blood to be injected in this way is sucked into the catheter 20 through a large number of introduction holes 28 formed in the wall surface of the introduction tube 22 that extends into the vicinity of the balloon 20B of the catheter 20, and the connector 18b2. , 18a1 and is introduced into the main body 10. The discharge hole 27 corresponds to the first opening of the present invention, and the introduction hole 28 corresponds to the second opening.

In the present embodiment configured as described above, the operation amount of each pump and the constant temperature bath 14 is centrally managed by the electronic control unit 40. As shown in the block diagram of FIG. 2, the electronic control unit 40 is composed of a logical operation circuit centered on a normal microcomputer, and receives commands from the operation unit 50 operated by a doctor via the input / output port 42. When the input is input via the CPU 44, the input is decoded by the CPU 44, and the control program according to the decoding result stores various programs.
It is selected from M46 and processed by the CPU 44. The input / output port 42 is also connected to each pump, the constant temperature bath 14, and the oxygen compressor 16a, and outputs a drive signal to each device and inputs the temperature of the constant temperature bath 14. RAM 48 also performs temporary storage of information and assists the operation of CPU 44.

4 and 6 are flowcharts of the control program stored in the ROM 46 and selectively executed by the CPU 44 as described above. Hereinafter, each control program will be explained separately.

FIG. 4 is a flow chart of a drug solution concentration control program which is a processing procedure when operating the drug mixing section 12. Operation part
When the processing of this program is instructed from 50, the CPU 44 interrupts this program every predetermined time. First, in step 100, the operating amount of the pump Pin is confirmed in order to know the amount of blood introduced into the main body 10 by the pump Pin. As described above, the balloon 20B of the catheter 20 blocks the dominant blood vessel in the diseased area, and the natural blood flow to this portion is blocked. Therefore, in order to prevent thrombus from being generated in the blocked natural blood flow and to introduce blood into the main body 10 so as to match the control blood flow to the control blood vessel after the occlusion, the operation amount of the pump Pin is operated in advance. It is set by the part 50. When the confirmation of the pump Pin operation amount is completed, step 110 is subsequently processed, and the doctor confirms the desired chemical concentration set in the operation unit 50 in advance. From the two quantities confirmed in this way, the next step 12
At 0, the operating quantity of the pump Pm1 is calculated, and step 13
A control signal is output to drive the pump Pm1 with the operation amount actually calculated at 0. Such concentration control is repeatedly processed by the CPU 44 every very short time, and strict control of the concentration is performed.

Next, the blood temperature control program of FIG. 5 will be described. This is for controlling the constant temperature bath constituting the blood temperature control unit 14, and when the processing of this program is started by the CPU 44, the operation unit 50 is first operated by step 200.
Confirmation of the desired blood temperature set to is performed. Then, the temperature of the constant temperature oven is measured next in step 210, and in the next step 220, the control output of the constant temperature oven is made so that the temperature of the constant temperature oven matches the set temperature based on the two temperature differences. Here, the control output of the constant temperature bath means that the temperature of the constant temperature bath matches the set temperature as described above, and various conventional control methods are adopted. For example,
When there is a large difference between the temperature of the constant temperature bath and the set temperature, heating or cooling is performed with the maximum capacity of the constant temperature bath to reduce the capacity as the temperature difference becomes smaller, or the temperature and flow rate of blood flowing into the constant temperature bath are measured in advance. Then, the control output to the constant temperature bath is changed.

Next, an oxygen content control program that controls the operation of the oxygen content control unit 16 will be described based on the flowchart of FIG. When the processing of this program is instructed from the operation unit 50, first, at step 300, the operation amount of the pump Pm1 is confirmed. A pump for mixing a drug solution of a predetermined concentration with blood by the processing of the drug solution concentration control program described above.
The operation amount of Pm1 is uniquely determined, or when controlling only the amount of oxygen contained in the blood, the pump Pm1 of the pump Pm1 is prepared by preparing physiological saline or the like in the drug solution tank 12a and mixing it with blood. The working amount is determined. Therefore, in step 300, the operation amount of the pump Pm1 determined from these various conditions is confirmed. Next, in step 310, the operation amount of the pump Pm2 is determined. The operation amount of the pump Pm2 means an operation amount sufficient to transfer the same amount as the amount of the drug solution or the like mixed with blood by the operation amount of the pump Pm1 confirmed in step 300. That is, as is apparent from FIG. 2, the pumps Pm1 and Pm2 prevent the chemicals exposed to high-pressure oxygen by the oxygen compressor 16a from unnecessarily flowing back or out into the chemical tank 12a or the Y-shaped communicating portion 13. This provides a pressure shut-off action for operating. Therefore, the operating amount of the pump Pm1 and the operating amount of the pump Pm2 are made equal to each other, and control is performed so that a constant chemical liquid always moves between these two pumps. In the following step 320,
The operation amount of the oxygen compressor 16a is determined as follows. First, when the blood oxygen content desired by the doctor is determined by the operation unit 50, the oxygen partial pressure PO ₂ necessary for increasing the blood oxygen content of blood to be contacted later to the set value is calculated, and the pump Pm1 is calculated. , Pm2, when exposed to high-pressure oxygen, the oxygen partial pressure PO ₂
Is calculated, and the operation amount of the oxygen compressor 16a is inversely calculated. In this way, after the operation amounts of the pump Pm2 and the oxygen compressor 16a are determined, step 330 is processed, and the drive signal corresponding to the operation amount is output to the pump Pm2 and the oxygen compressor 16a.

Each of the above programs can be selected individually or simultaneously,
When performed and the desired treatment of blood is complete, the blood is drained by the pump Pout via connector 18a2. This discharge amount is determined by the operation amount by which the electronic control unit 40 operates the pump Pm2 faithfully to the command from the operation unit 50. The electronic control unit 40, the chemical solution mixing unit 12, and the pump Pm1 correspond to the chemical solution supply means of the present invention, and the chemical solution concentration control program corresponds to the processing of the chemical solution supply means. Also,
The electronic control unit 40 and the constant temperature bath 14 correspond to temperature control means,
The blood temperature control program corresponds to the processing of the temperature control means. Further, the electronic control unit 40 and the oxygen content control unit 16 correspond to oxygen supply means, and the oxygen content control program corresponds to processing of the oxygen supply means. Further, the electronic control unit 40 and the operation unit 50 correspond to the selection means.

It is apparent that the treatment device of this embodiment configured as described above has the following effects.

First, a case where only the drug mixing section 12 in the main body 10 is operated will be described.

According to the usual intravascular administration of a drug, the drug is delivered to the natural bloodstream and reaches the diseased site. Therefore, in a bronchial artery with a blood flow rate of 50 ml / min, 20 mg was administered by usual intravascular administration.
If mitomycin C of is administered by infusion for 10 minutes, the drug concentration in tissue blood is only 20 mg / 500 g = 0.004%.

However, if the blood flow of the bronchial artery infused from this treatment device is suppressed to 10 ml using the pump Pout and the same amount (20 mg) and the same time (10 minutes) of blood administration are performed with the drug mixture 12, the drug It is possible to raise the concentration to 0.02%. Moreover, if the pump Pout is continuously controlled to limit the infused blood flow even after the end of the drug administration due to the high concentration as described above, the tissue blood flow is suppressed to a low level, so that the tissue residual time of the drug at the disease site is also reduced. It becomes controllable. That is, according to the present treatment device, it is possible to cause an anticancer drug or the like, which is subject to the limitation of the total dose in terms of side effects and the like, to act at a high concentration in a diseased area for a long time, and a new topical agent that did not exist in the past. It results in pharmacokinetics.

Next, the effect when the blood temperature control unit 14 operates will be described. As is well known, certain types of local disease such as cancer are treated with 42 to 43
It has been found that there is a therapeutic effect when warmed to [° C].
However, the only way to warm it is to use a warm compress from the outside or a secondary effect when warming the whole body, and it is not possible to accurately control the local temperature of the disease to the desired temperature. It was impossible. Further, there is a limit to the amount of heat given by a catheter with a heater, and it is the present situation that it can only be used for treatment of a limited area. That is, the blood flow also has a function of keeping the body temperature constant, and it is impossible in itself to control the temperature of the diseased part to a desired value without controlling it.

However, if the blood temperature control unit 14 of the present embodiment is operated, it becomes possible to accurately control the temperature of the blood itself, which becomes the blood flow in the tissue of the diseased area, and even the blood flow amount is controlled by the pump Pout. Since it is controllable, even the amount of heat given to the diseased part can be freely controlled, and a new warming treatment method is created. Furthermore, by combining the drug mixture 12 and the blood temperature control unit 14, it is also possible to control the temperature of the drug administered in the blood to a temperature at which the effect is maximum and inject it into the body. Is expected to decrease.

On the other hand, the oxygen content control unit 16 independently has the following effects. When the area of the lumen in the blood vessel is reduced for some reason, sufficient oxygen is not supplied to the dominant region. At this time, the conventional oxygen administration method can only effectively increase the oxygen content in the inspiratory air through the airway, and the local oxygen transfer is less than the total oxygen administration amount. Alternatively, in the case of lung disease and right / left Shun heart disease, it was even more inefficient depending on the method. However, according to the present treatment device, the oxygen content in blood can be controlled to a desired value, and the blood can be directly injected into the diseased area. Therefore, regardless of the presence of any disease, oxygen can be freely supplied without any risk, and the tissue can be protected from the risk of necrosis. Furthermore, the following effects can be obtained by coupling with the drug mixing section 12 described above. As described above, the drug may be mixed into a blood amount smaller than the natural blood flow to increase the drug concentration and then injected into the body. However, when the blood flow rate is small, the oxygen supply amount may be insufficient. Therefore, when the blood flow rate is limited, the oxygen content control unit 16 may be operated at the same time to secure a sufficient oxygen supply amount. Also, if the blood vessel you are injecting is narrowing for some reason, simply pump
It is also possible to inject blood at a higher pressure with Pout.

It should be noted that a catheter having a heat insulating effect may be used including the catheter 20 so that the warmed blood is smoothly introduced into the body.

Further, in the above embodiment, in order to minimize the burden on the human body, the blood to be processed with one catheter is derived,
Since the blood flow in the desired blood vessel is blocked and the blood after the treatment is injected, the possibility that a blood clot will occur in the blocked blood is completely avoided.

Conventionally, the treatment of drawing blood out of the body and injecting it into the body again has been performed only for extremely special treatments such as artificial dialysis and artificial heart-lung. However, there are none of these that lead blood out of the body as described above while completely blocking a blood vessel at a predetermined site, and artificial dialysis machines and the like provide a shunt for blood flow in the body. It is clear from the above description that a part of the blood is derived and returned to the body after the dialysis treatment, and the constitution, action, and effect are different from those of the present embodiment.

[Effects of the Invention] As described in detail above with reference to the embodiments, according to the present invention,
It is possible to give a completely new strategy for intravascular administration of drugs and oxygen transport that can only rely on conventional natural blood flow, and it is possible to realize new local pharmacokinetics, local oxygen supply, and local hyperthermia. . In addition, these new treatments selectively and locally provide effective treatments such as high concentration, long-term drug administration, high concentration of oxygen supply, effective local hyperthermia, which were conventionally considered difficult. Is. Therefore, this device can be said to be a therapeutic device which can greatly contribute to medical progress and can be expected to have excellent therapeutic effects.

[Brief description of drawings]

FIG. 1 is a schematic configuration explanatory view of a treatment apparatus of the present invention, FIG. 2 is a configuration block diagram of a treatment apparatus main body of an embodiment, FIG. 3 is a partially exploded explanatory view of a catheter connected to the main body, FIG. Is a flow chart of a drug solution concentration control program executed by the main body, FIG. 5 is a flow chart of a blood temperature control program, and FIG. 6 is a flow chart of an oxygen content control program. Pout, Pin, Pm1, Pm2 …… Pump 12 …… Drug mixing section 14 …… Blood temperature control section 16 …… Oxygen content control section 20 …… Catheter 20B …… Balloon 22 …… Introduction tube 24 …… Infusion tube 26 ...... Balloon control tube

Claims (1)

[Claims] 1. A liquid medicine supply means for supplying a liquid medicine to blood based on the blood flow rate, a temperature control means for controlling the blood temperature based on the blood flow volume, and an oxygen supply means for supplying oxygen to the blood based on the blood flow volume. A selection means for selecting at least one means from the chemical solution supply means, the temperature control means, and the oxygen supply means; and a selection means for selecting blood having a predetermined flow rate from the inflow section. Means for performing a predetermined process on the basis of the predetermined flow rate by the means, and connecting one end to the inflow part and the outflow part of the blood processing means for flowing out from the outflow part at the predetermined flow rate. The two tubular members are made into one bundle, the first opening is formed at the other end of the one tubular member connected to the outflow part, and the outflow part is closer to the outflow part than the first opening. Connect to the inflow part in position A tubular catheter having a second opening formed in one tubular member, and a balloon catheter having an expandable balloon in an intermediate portion between positions where the first opening and the second opening are formed. A treatment device characterized by the above.