JP7301509B2 - therapy equipment - Google Patents

Description

TECHNICAL FIELD The present invention relates to the technology of a therapeutic device, and more particularly, it comprises a blood circuit in which blood collected from the arterial side of a patient is supplied to a hemodialysis device, and blood dialyzed by the hemodialysis device is returned to the venous side. It relates to the technology of therapeutic devices.

Conventionally, patients suffering from renal failure undergo artificial dialysis for the purpose of removing waste products and excess water from the blood. In artificial dialysis, blood is collected from the patient's arterial side, and after performing dialysis in which waste products and excess water in the blood are transferred to a dialysate through an artificial membrane using a dialyzer, the blood is returned to the venous side.

By the way, in the artificial dialysis described above, there is known a technique in which an infusion solution containing gas as microbubbles is administered to the blood using a mixer and mixed with the blood so that the concentration of microbubbles is high. (See, for example, Patent Document 1). In the conventional microbubble mixing method in artificial dialysis, a negative pressure is generated by rotating the stirring blade inside the turbo mixer, the infusion solution and the mixing gas are aspirated, stirred by the blade, and hydrogen gas is made finer, and the hydrogen gas is dissolved in the acidic hydrogen bubble water. Then, by mixing the infusion solution with the blood from the blood passage on the venous side, the infusion solution mixed with microbubbles is injected into the patient's body into the blood vessel.
However, in the conventional method, a negative pressure is generated by rotating the blades for stirring inside the turbo mixer, sucking the infusion solution and the gas for mixing, stirring with the blades, and atomizing the hydrogen gas. Therefore, there is a risk of destroying blood cells such as erythrocytes and leukocytes when microbubbles are mixed with blood. In addition, since fine air bubbles are created using a turbomixer, the size of the device is increased, and there are cases where sufficient space for artificial dialysis cannot be secured.

Japanese Patent No. 6189562

Therefore, in view of the problems described above, the present invention provides a treatment apparatus that can generate microbubbles in an infusion solution during artificial dialysis and that can save space. With the goal.

The problems to be solved by the present invention are as described above, and the means for solving these problems will now be described.

That is, in the present invention, a microbubble mixing device for mixing microbubbles containing an infusion gas with blood is provided,
The microbubble mixing device includes an in-line unit that is placed in the middle of the blood-feeding passage and releases the infusion gas as microbubbles,
The in-line unit includes an internal passage connected to the passage, a means for pressurizing an injection gas, and bubbles arranged on the wall surface of the internal passage for releasing the injected gas as fine bubbles. a generation medium,
The microbubble generating medium is made of a carbon-based porous material and has fine pores with a diameter of several μm to several tens of μm,
In the internal passage connected to the middle portion of the passage, the gas for injection is formed into fine bubbles from the bubble-generating medium and injected into the blood.

Moreover, in the present invention, the injection gas may contain any of hydrogen, oxygen, ozone, nitrogen, carbon dioxide, or nitrous oxide.

Further, in the present invention, a gas discharge passage for discharging surplus gas is provided in the middle of the internal passage,
A valve may be provided in the middle of the gas discharge passage.

As effects of the present invention, the following effects are obtained.

In the present invention, when microbubbles are mixed with blood, blood cells such as red blood cells and white blood cells are not destroyed and can be mixed without applying stress. Moreover, even when microbubbles such as hydrogen are mixed with blood in artificial dialysis, space can be saved because there is no need to provide a separate space for placing a microbubble generator.

1 is a schematic diagram showing a therapeutic device according to an embodiment of the invention; FIG. BRIEF DESCRIPTION OF THE DRAWINGS The schematic sectional drawing which shows the micro-bubble mixing apparatus which concerns on one Embodiment of this invention. Fig. 2 is a schematic diagram showing a therapeutic device according to another embodiment of the invention;

Next, embodiments of the invention will be described.

First, a therapeutic device 1 according to one embodiment of the present invention will be described with reference to FIG.
The treatment apparatus 1 is a treatment apparatus that extracts a patient's blood from the body, removes disease-causing substances, or administers a drug, and returns the blood to the patient's body. For example, the treatment apparatus 1 is an apparatus used for artificial dialysis, and includes a hemodialysis apparatus 10 and a blood circuit 20 consisting of an arterial circuit 20A and a venous circuit 20B.
In this embodiment, the therapeutic device is a device used for artificial dialysis including a hemodialysis device. The therapeutic device is not limited to this as long as it is returned to the body. For example, it may be a therapeutic device used for plasmapheresis or a blood circulation device using an artificial heart for dealing with heart disease or the like.
The hemodialysis device 10 is a device that dialyzes blood collected from the arterial side of a patient, removes impurities and excess water, and returns the blood to the patient. The blood circuit 20 is a circuit that connects the arterial side to the venous side of the arteriovenous anastomotic site A, and introduces blood containing impurities and excess water flowing from the arterial side into the hemodialysis apparatus 10, where hemodialysis is performed. The blood from which impurities and excess water have been removed from the apparatus 10 is allowed to flow out to the vein side.

Next, the hemodialyzer 10 will be described in detail.
The hemodialyzer 10 includes a blood pump 11 , a dialyzer 12 and a dialysate supply device 13 . An arterial pressure monitor 15 is connected between the blood pump 11 and the dialyzer 12 . A venous pressure monitor 16 and an air bubble detector 17 are connected between the dialyzer 12 and the arteriovenous anastomosis A on the venous side.

The blood pump 11 is a pump that collects blood from the arterial side of the arteriovenous anastomosis A, and is driven by electric power. The blood pump 11 continuously sucks blood with negative pressure. As a result, blood is collected from the arterial side.
The dialyzer 12 is a device that filters and removes impurities and excess water from the blood using the difference in concentration between the hemodialysate and the blood. The dialyzer 12 includes a cylindrical case 31 and a blood passage 32 made up of a bundle of thin tubular dialysis membranes provided in the case 31 . Blood flows inside the dialysis membrane, and dialysate flows outside the dialysis membrane. The dialysis membrane is provided with numerous small holes, and impurities and excess water contained in the blood passing through the blood passage 32 pass through the holes and move to the dialysate side. This filters the blood and dialysis is performed.
The dialysate supply device 13 is a device that supplies the dialysate into the case 31 of the dialyzer 12, and includes pressure feeding means (not shown) such as a pump as supply means.
The dialysate containing impurities and excess water is filtered and discharged as waste. Then, the filtered dialysate returns to the dialysate supply device 13 and is supplied from the dialysate supply device 13 to the dialyzer 12 again.

The arterial pressure monitor 15 is arranged in the middle of the arterial circuit 20A and is a device for continuously observing the arterial pressure. The venous pressure monitor 16 is arranged in the middle of the venous circuit 20B and is a device for continuously observing the venous pressure. If the arterial pressure or venous pressure exceeds a predetermined value range, dialysis is stopped. The air bubble detector 17 is a device for detecting air bubbles having a large diameter in blood. When the air bubble detector 17 detects air bubbles of a predetermined diameter or larger, artificial dialysis is stopped.

Next, the microbubble mixing device 50 will be described.
The microbubble mixing device 50 is a device for mixing microbubbles containing gas for injection into blood, and is arranged in the blood circuit 20 of the therapeutic device 1 . More specifically, the in-line unit 61 of the microbubble mixing device 50 is arranged in the middle of the vein side circuit 20B. An infusate gas is a gas that is injected into the body as microbubbles and includes any of hydrogen, oxygen, ozone, nitrogen, carbon dioxide, or nitrous oxide.

The fine-bubble mixing device 50 includes an in-line unit 61 , a pressure regulator 73 that is pressure feeding means, and a canister 74 .
The in-line type unit 61 is a unit arranged between the dialyzer 12 and the vein side of the arteriovenous anastomosis A, and is a unit for releasing the infusion gas as fine bubbles.

The in-line type unit 61 is composed of a cylindrical body 70 having a tubular internal passage 71 inside, and a bubble generating medium 72 provided in a portion of the wall surface 71A of the internal passage 71 which is recessed. be.

The main body 70 is made of, for example, fluororesin (fluorocarbon resin) such as PTFE. Note that the heat-resistant synthetic resin is not limited to the fluororesin.
The internal passage 71 is a space provided in the main body 70 through which blood flows, and is connected to the vein side circuit 20B.

The bubble generating medium 72 is arranged on the wall surface 71A of the internal passage 71 . The bubble-generating medium 72 is arranged parallel to the direction in which the blood, which is the liquid in the internal passage 71, flows. The bubble generation medium 72 is made of a carbon-based porous material, and has a large number of fine pores 72A with a diameter of several micrometers to several tens of micrometers, as shown in FIG.

A carbon-based porous material is a composite material containing only carbon or carbon and ceramic, and is an inorganic material. A film with a thickness of several nanometers is formed on the surface of the carbon-based porous material. The film is formed of an inorganic film containing silicon. When the blood, which is a liquid, flows through the internal passage 71, the blood passes through the inside of the air bubble generating medium 72, which is electrically conductive and has an inorganic film formed on its surface. Since the capillary number, which is a dimensionless number, becomes low, the capillary force prevails, and a large number of microbubbles are generated from the fine holes 72A with a diameter of several micrometers to several tens of micrometers.

The pressure regulator 73 is means for pumping gas into the bubble generating medium 72, and is a device for adjusting the pressure of the gas to be pumped. For example, the pressure regulator 73 is composed of a regulating valve, and is provided with an operation section for adjusting the opening degree of the regulating valve and a display section for displaying the pressure of the injected gas adjusted by the regulating valve. there is The pressure regulator 73 adjusts the pressure of the injected gas by adjusting the opening degree of the regulating valve.

The canister 74 is a container in which compressed gas is stored, and is connected to the bubble generating medium through the pressure regulator 73 . Since the gas in the canister 74 is prepressurized, by adjusting the opening of the pressure regulator 73, the gas can be pressure-fed to the bubble generation medium 72 at maximum the same pressure as the pressure prepressurized in the canister 74. can do.

Further, as shown in FIG. 2, a gas discharge passage 76 for discharging surplus gas can be provided in the middle of the internal passage 71 . A valve 77 is provided in the middle of the gas discharge passage 76 . By opening and closing the valve 77, the surplus gas can be discharged.

Next, the microbubble mixing device 50 for generating bubbles in blood will be described.

First, when performing artificial dialysis, blood is collected from the arterial side of the arteriovenous anastomosis A by the blood pump 11 and sent to the dialyzer 12 through the arterial circuit 20A.
In the dialyzer 12, impurities and excess water are filtered out from the blood using the concentration difference between the dialysate and the blood. More specifically, impurities and excess water contained in the blood passing through the blood passage 32 pass through the holes and move to the dialysate side, whereby the blood is filtered and dialysis is performed.

Blood from which impurities and excess water have been removed by dialysis flows into the venous circuit 20B. Then, in the internal passage 71 connected to the middle portion of the vein side circuit 20B, the infusion gas becomes fine bubbles and is injected into the blood through fine holes 72A of the bubble generating medium 72. FIG. Microbubbles are bubbles with a size (diameter) of less than 100 μm under normal temperature and normal pressure. The bubble number density in the blood is 10<8>/cc or more and 10<10>/cc or less. As an indicator of bubble number density, a method of confirming light scattering by laser light may be used. When a control experiment was conducted using normal saline, almost no scattering of light was observed with normal saline. Scattering makes it possible to see laser light in saline.

With such a configuration, microbubbles can be easily mixed into blood using the microbubble mixing device 50 . In blood, microbubbles act as hollow capsules that can deliver infusate gases, including either hydrogen, oxygen, ozone, nitrogen, carbon dioxide, or nitrous oxide, to affected areas of the body.

Further, the operator can roughly calculate the amount of microbubbles generated by controlling the remaining amount of the canister 74 and the time for moving the infusion solution.
Also, the amount of microbubbles generated using the microbubble mixer 50 can be easily adjusted by adjusting the pressure with the pressure regulator 73 . Further, by increasing the pressure of the gas for injection by the pressure regulator 73, fine bubbles can be generated up to the saturation amount.

Further, as another embodiment, as shown in FIG. 3, when mixing the infusion into the vein side circuit 20B, it is possible to dispose the microbubble mixing device 50 in the middle of the infusion circuit 80 that sends the infusion. .
The infusion circuit 80 is a passage for supplying the infusion from the infusion container 81 to the intravenous circuit 20B. An infusion solution is a liquid for transporting nutrients, drugs, etc. into the body, and is, for example, physiological saline.

The microbubble mixing device 50 is a device for mixing microbubbles containing gas for injection into an infusion solution, and is arranged in the middle of the infusion circuit 80 . More specifically, the in-line unit 61 of the microbubble mixing device 50 is arranged in the middle of the infusion circuit 80 .
In addition, since the structure of the micro-bubble mixing apparatus 50 is the same as that of the micro-bubble mixing apparatus 50 of 1st embodiment, description is abbreviate|omitted.

Next, the microbubble mixing device 50 for generating bubbles during infusion will be described.

First, when performing artificial dialysis, blood flows through the venous circuit 20B. At the same time, the infusion is supplied from the infusion container 81 to the infusion circuit 80 . In the internal passage 71 connected to the middle portion of the infusion circuit 80 , the gas for injection is turned into fine bubbles from the bubble generating medium 72 and injected into the infusion. Microbubbles are bubbles with a size (diameter) of less than 100 μm under normal temperature and normal pressure. The number density of air bubbles in the infusion solution is 10<8>/cc or more and 10<10>/cc or less. As an indicator of bubble number density, a method of confirming light scattering by laser light may be used. When a control experiment was conducted using normal saline, almost no light scattering was observed in normal liquids. , it becomes possible to visually recognize the laser light in the infusion solution.
The infusion solution containing microbubbles passes through the infusion circuit 80, is mixed with the blood flowing through the vein side circuit 20B, and is returned to the patient's body. For example, when the injection gas is hydrogen molecules (H2), the drug solution is transported in the blood in a state of a drug film and a nutrient film on the surface of the microbubble film in which the hydrogen gas is taken in. Since it functions as a hollow capsule, it can prevent immune cells from erroneously detecting microbubbles in the blood as foreign substances, so that the medicines and nutrients carried by the microbubbles can be distributed throughout the body.

With such a configuration, microbubbles can be easily mixed into blood using the microbubble mixing device 50 . The operator can roughly calculate the amount of microbubbles generated by controlling the remaining amount of the canister 74 and the time for moving the infusion solution.
Also, the amount of microbubbles generated using the microbubble mixer 50 can be easily adjusted by adjusting the pressure with the pressure regulator 73 . Further, by increasing the pressure of the gas for injection by the pressure regulator 73, fine bubbles can be generated up to the saturation amount.

As described above, the treatment apparatus 1 includes the microbubble mixing device 50 for mixing microbubbles containing the gas for injection into the blood. It comprises an in-line unit 61 for releasing the infusion gas as microbubbles, the in-line unit 61 comprising an internal passage 71 connected to the blood circuit 20, a pressure regulator 73 for injecting the infusion gas, and an internal passage. and a bubble generating medium 72 which is arranged on the wall surface of 71 and releases the injected gas as fine bubbles.

With this configuration, even when microbubbles such as hydrogen are mixed with blood in artificial dialysis, blood cells such as erythrocytes and leukocytes are not destroyed when microbubbles are mixed with blood, and stress is reduced. It can be mixed without pouring. In addition, since there is no need to provide a separate space for placing the microbubble generator, space can be saved.

The infusate gas may also comprise any of hydrogen, oxygen, ozone, nitrogen, carbon dioxide, or nitrous oxide.
With this configuration, for example, when the gas to be injected is hydrogen molecules (H2), the surface of the microbubble film in which the hydrogen gas is taken in is coated with the chemical solution as the drug film and the nutrient as the nutrient film. Since it functions as a hollow capsule that is transported in the blood in this state, it can prevent immune cells from erroneously sensing microbubbles in the blood as foreign substances, so hydrogen molecules can be efficiently introduced into the blood. It can be delivered, and the drug and nutrient solution carried by the microbubbles can be distributed throughout the body.

A gas discharge passage 76 for discharging surplus gas is provided in the middle of the internal passage 71 and a valve 77 is provided in the middle of the gas discharge passage 76 .
By configuring in this way, it is possible to generate fine bubbles up to a saturated amount while discharging surplus gas.

Reference Signs List 1 therapeutic device 20 blood circuit 50 microbubble mixing device 61 in-line unit 71 internal passage 72 bubble generation medium 73 pressure regulator 76 gas discharge passage 77 valve

Claims (3)

Equipped with a microbubble mixing device for mixing microbubbles containing infusion gas with blood,
The microbubble mixing device includes an in-line unit that is placed in the middle of the blood-feeding passage and releases the infusion gas as microbubbles,
The in-line unit includes an internal passage connected to the passage, a means for pressurizing an injection gas, and bubbles arranged on the wall surface of the internal passage for releasing the injected gas as fine bubbles. a generation medium ,
The microbubble generating medium is made of a carbon-based porous material and has fine pores with a diameter of several μm to several tens of μm,
A treatment apparatus in which the gas for injection is converted into microbubbles from the bubble-generating medium and injected into the blood in the internal passageway connected to the middle portion of the passageway. 2. The therapeutic device of claim 1, wherein the infusate gas comprises any of hydrogen, oxygen, ozone, nitrogen, carbon dioxide, or nitrous oxide. A gas discharge passage for discharging surplus gas is provided in the middle of the internal passage,
3. The treatment apparatus according to claim 1, wherein a valve is provided in the middle of said gas discharge passage.

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