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WO2020216290A1 - Procédé et appareil pour commander le mouvement ou la position d'une substance dans un corps vivant - Google Patents

Procédé et appareil pour commander le mouvement ou la position d'une substance dans un corps vivant Download PDF

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Publication number
WO2020216290A1
WO2020216290A1 PCT/CN2020/086399 CN2020086399W WO2020216290A1 WO 2020216290 A1 WO2020216290 A1 WO 2020216290A1 CN 2020086399 W CN2020086399 W CN 2020086399W WO 2020216290 A1 WO2020216290 A1 WO 2020216290A1
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Prior art keywords
electric field
living body
electrode
substance
adjustable
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Ceased
Application number
PCT/CN2020/086399
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English (en)
Chinese (zh)
Inventor
乐飚
王丽江
唐万福
奚勇
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Shanghai Bixiufu Enterprise Management Co Ltd
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Shanghai Bixiufu Enterprise Management Co Ltd
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Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents

Definitions

  • the invention relates to a method and device for controlling the movement or position of a substance in a living body.
  • External medicine can be administered in a targeted manner, which is fast, convenient, efficient and low-toxic.
  • Oral or intravenous injection and other internal medications are generally systemic and cannot be administered locally.
  • the goal of administration is to treat and minimize the side effects of the drug.
  • Some diseases such as cancer
  • oral chemotherapy drugs for cancer treatment, various side effects such as nausea and vomiting will occur. , Dry mouth, lack of appetite, numb hands and feet, hair loss, etc., most chemotherapy drugs have different degrees of bone marrow suppression, and bone marrow suppression is often the dose-limiting toxicity of anti-tumor drugs.
  • Bone marrow suppression can be manifested as a reduction of white blood cells, especially granulocytes in the early stage. In severe cases, platelets, red blood cells, and hemoglobin can be reduced. Different drugs have different effects on the bone marrow, so the degree of response is different, and patients can also There are manifestations of fatigue, weakness, decreased resistance, susceptibility to infection, fever, bleeding, etc., resulting in a general decline in the quality of life of patients, and even being forced to stop treatment due to intolerance. At the same time, chemotherapeutic drugs are generally immunosuppressive drugs, which inhibit the immune function of the body to varying degrees. The immune system of the body plays an important role in destroying the remaining tumor cells in the body. When the immune function is low, the tumor is not easy to be controlled. , But accelerate the process of recurrence or metastasis.
  • the purpose of the present invention is to provide a method and device for controlling the movement or position of a substance in a living body.
  • the first invention provides a method for controlling the movement or position of a substance in a living body.
  • the method at least includes the following steps:
  • the electric field generating device includes a contact electrode and an external electrode, the external electrode includes more than one different electrode, and the position of the different electrode is adjustable;
  • the second invention provides a method for expelling charged substances from a living body.
  • the method at least includes the following steps:
  • the electric field generating device includes a contact electrode and an external electrode, the external electrode includes more than one different electrode, and the position of the different electrode is adjustable;
  • the third invention provides an electric field positioning drug delivery device, which at least includes:
  • the space electric field outer electrode is used to form a space electric field between the space electric field contact electrode, including more than two different electrodes, the position of each different electrode is adjustable, and is used to adjust the coverage area of the space electric field;
  • the regulating unit is used to regulate and control the performance of the space electric field, including one or more of electric field strength, electric field direction, electric field pulse frequency, and electric field range, and control the movement trajectory of the charged agent in the living body.
  • the fourth invention provides the use of the aforementioned electric field positioning drug delivery device in any one or more of the following: (1) positioning drug delivery; (2) enriching metal ions.
  • the fifth invention provides a method for controlling the movement trajectory of an ionic preparation in vivo.
  • the method at least includes the following steps:
  • Adjust and control the performance of the spatial electric field including one or more of electric field strength, electric field direction, electric field pulse frequency, and electric field range, and control the trajectory of the ionic agent in vivo.
  • the method and device for controlling the movement or position of a substance in a living body of the present invention has the following beneficial effects:
  • the invention can act on the charged substances in the living body through the electric field, make it move or excrete in a predetermined way, can act on tumor cells, act on drugs in the organism, act on water in the organism, act on the nerves in the organism, and act on heavy metals in the organism. Ions, acting on ions in organisms, acting on chemical reaction processes, controlling the sequence of reactions, catalyzing, and preventing reactions of some substances. It can achieve assisted growth, treatment, drug delivery, swelling, modification, and catalysis.
  • the invention is safe for the human body, high field strength requires high voltage, and preventing tip discharge is a sophisticated problem in high field strength electrostatics.
  • Equipotential electric field technology is adopted to effectively prevent tip discharge and make product equipment comply with national regulations. No need to worry about electric shock, the equipotential electric field technology is safer.
  • Precise positioning and aggregation of drugs can greatly reduce the dosage and improve the efficiency of local administration.
  • the amount of intravenous drugs can be reduced several to ten times. Under the action of an electric field, the drugs can be targeted to focus on the lesion. In this way, the target
  • the concentration of the drug in the site is hundreds or even thousands of times higher than that in other sites, the drug effect can be increased dozens of times, the applicability is stronger, and the application is wider.
  • Figure 1 shows a schematic diagram of the structure of the electric field positioning drug delivery device of the present invention.
  • Figure 2 is a schematic circuit diagram of the electric field positioning drug delivery device of the present invention.
  • Figure 3 shows a flow chart of the verification experiment of the electric field positioning drug delivery device of the present invention.
  • Figure 4 is a schematic diagram of the force of the present invention on the negatively charged tissues in the organism (the external electrode is negative).
  • Figure 5 is a schematic diagram of the force of the present invention on the negatively charged tissues in the organism (the external electrode is positive).
  • Ionic drugs are charged bodies, and the Coulomb force F received by charged bodies in an electric field
  • the charged drug is subjected to a force with a certain direction in the electric field.
  • this force is greater than other forces on the drug molecule (or particle)
  • the charged drug particle will Do directional movement in the direction of the electric field.
  • the charged ionic drug or drug When the electric field is irradiated to the localized drug delivery site (such as the sole of the foot), the charged ionic drug or drug will move in the direction of the electric field and pass through the epidermis and dermis. Part of the drug will pass through the capillaries, and the rest will continue to penetrate the capillaries and eventually gather At the location (foot).
  • the natural electric field barrier or boundary formed between the area covered by the spatial electric field and the uncovered area ensures that the ionic (charged) reagent is in the focus or treatment area within the set conditions, and continuous treatment is implemented.
  • the setting conditions refer to parameters such as pharmaceutical measurement; electric field strength; action time. Reagents that exchange with the lesion tissue and lose their charge activity or naturally inactivate reagents are transported out of the electric field shield through blood vessels, and are mainly excreted through kidney or liver metabolism, and partly through sweat glands or feces.
  • the method of drug delivery from capillaries into various tissues is called free diffusion drug delivery.
  • the theory of diffusion movement has been clearly studied, and the diffusion rate is directly proportional to the concentration difference.
  • V K ⁇ (C 1 -C 2 ) (ii)
  • the diameter of capillaries is 6 ⁇ 10 3 to 7 ⁇ 10 3 nm, the diameter of drug molecules is generally less than 100 nm, and the diameter of water molecules is 0.2 nm.
  • the diffusion rate is proportional to the concentration difference, the drug delivery is slow and the systemic effect cannot be directed.
  • the charged drug molecule is under the action of an electric field, the drug molecule moves toward the outer wall of the capillary under the action of the electric field, which greatly increases the concentration of the drug at the target site (more than 1000 times). In this way, C 1 does not increase or even decrease.
  • the absorption rate of the drug in this part is improved, and the concentration is greatly increased.
  • the method for controlling the movement or position of a substance in a living body at least includes the following steps:
  • the electric field generating device includes a contact electrode and an external electrode, the external electrode includes more than one different electrode, and the position of the different electrode is adjustable;
  • the performance of adjusting the electric field is selected from one or more of adjusting the position of the different electrode, the intensity of the electric field, the direction of the electric field, the pulse frequency of the electric field, and the range of the electric field.
  • the living body is a living animal body. Further, it is a mammal.
  • the mammals are preferably rodents, artiodactyls, odd-hoofed animals, lagomorphs, primates and the like.
  • the primates are preferably monkeys, apes or humans.
  • the contact electrode is grounded.
  • the external electrode is not in contact with the living body to be tested.
  • the different electrode is a point probe.
  • At least one substance in the living body is controlled to gather at the position where the electric field acts.
  • the substance is charged.
  • the substance is selected from one or more of charged medicaments, foreign harmful charged substances, and ions in organisms.
  • the charged medicament is one or more of charged injection medicament, charged oral medicament and charged rectal administration medicament.
  • it includes, but is not limited to, charged medicaments suitable for oral administration, sublingual injection, intravenous injection, acupoint injection, rectal drip administration, intramuscular injection, subcutaneous injection, etc.
  • the generating device further includes:
  • the power supply is used to provide electrical energy to the generating device
  • the contact electrode does not affect the selection of the position of the different electrode or the electrification condition.
  • the position of the different electrode and/or the performance of the electric field are confirmed according to the target site and target concentration.
  • the power supply is a high-voltage output power supply.
  • the power supply is a high-voltage output power supply formed by a battery or a direct current power supply DC through an AC excitation step-up transformer of an oscillating circuit.
  • the voltage of the electric field is adjustable from 0.001 kV to 120 kV
  • the current output is adjustable from 0.001 mA to 10000 mA
  • the working distance of the electric field is adjustable from 0.1 cm to 100 cm.
  • the voltage is taken according to the depth of action and the distance of the electric field; and/or the current is less than the limit that the living tissue can tolerate.
  • the power source of the electric field is direct current.
  • the positive pole of the DC high voltage power supply is connected to the living body at the same potential, the negative pole is connected to the external electrode, and the DC power supply is turned on to generate an electric field between the living body and the electrode. Electricity is generated at the same time. This electric power first acts on the positively charged substance in the living body. Negative electrode. The amount of electricity generated depends on the voltage between the electrodes and the amount of charged material. Utilizing the charge difference in the organism, it can pull positively charged materials, positive ions, conductive materials, and conductive materials with low friction.
  • the living body's equipotential is used as the negative electrode, and the external electrode is used as the positive electrode.
  • Turn on the DC power supply to generate an electric field between the living body and the electrode. Electricity is generated at the same time.
  • This electric power first acts on the living body. A negatively charged substance, this substance is first pulled towards the positive electrode. The amount of electricity generated depends on the voltage between the electrodes and the amount of charged material. Utilizing the charge difference in the organism, it can pull negatively charged materials, negative ions, conductive materials, and conductive materials with low friction.
  • the method for expelling charged substances from a living body at least includes the following steps:
  • the electric field generating device includes a contact electrode and an external electrode, the external electrode includes more than one different electrode, and the position of the different electrode is adjustable;
  • the performance of adjusting the electric field is selected from one or more of adjusting the position of the different electrode, electric field intensity, electric field direction, electric field pulse frequency, and electric field range.
  • the living body is a living animal body. Further, it is a mammal.
  • the mammals are preferably rodents, artiodactyls, odd-hoofed animals, lagomorphs, primates and the like.
  • the primates are preferably monkeys, apes or humans.
  • the contact electrode is grounded.
  • the external electrode is not in contact with the living body to be tested.
  • the different electrode is a point probe.
  • At least one substance in the living body is controlled to gather at the position where the electric field acts.
  • the substance is charged.
  • the substance is selected from one or more of harmful externally charged substances and ions in organisms.
  • the generating device further includes:
  • the power supply is used to provide electrical energy to the generating device
  • the contact electrode does not affect the selection of the position of the different electrode or the electrification condition.
  • the position of the different electrode and/or the performance of the electric field are confirmed according to the target site and target concentration.
  • the power supply is a high-voltage output power supply.
  • the power supply is a high-voltage output power supply formed by a battery or a direct current power supply DC through an AC excitation step-up transformer of an oscillating circuit.
  • the voltage of the electric field is adjustable from 0.001 kV to 120 kV, and the current output is adjustable from 0.001 mA to 10000 mA.
  • the voltage is taken according to the depth of action and the distance of the electric field; and/or the current is less than the limit that the living tissue can tolerate.
  • the power source of the electric field is direct current.
  • the present invention provides an electric field positioning drug delivery device, which at least includes:
  • the space electric field outer electrode is used to form a space electric field between the space electric field contact electrode, including more than two different electrodes, the position of each different electrode is adjustable, and is used to adjust the coverage area of the space electric field;
  • the regulating unit is used to regulate and control the performance of the space electric field, including one or more of electric field strength, electric field direction, electric field pulse frequency, and electric field range, and control the movement trajectory of the charged agent in the living body.
  • the spatial electric field contact electrode is used to connect with the living body to be measured, so that the living body to be measured and the spatial electric field contact electrode form an equipotential.
  • equipotential contact point may be the sole of the foot as shown in FIG. 1, or may be other parts of the living body to be tested, or be moisturizing, conductive grease, or the like.
  • the living body to be tested is a living animal body. Further, it is a mammal.
  • the mammals are preferably rodents, artiodactyls, odd-hoofed animals, lagomorphs, primates and the like.
  • the primates are preferably monkeys, apes or humans.
  • the spatial electric field contact electrode is grounded.
  • the external electrode of the spatial electric field may be in contact with the living body to be measured, or may not be in contact with the living body to be measured.
  • the different electrode is a point probe.
  • the charged agent is concentrated at the position where the electric field acts.
  • the charged agent is a charged agent.
  • the charged medicament is one or more of ionic injection medicaments, ionic oral medicaments and ionic rectal administration medicaments.
  • ionic agents suitable for various administration modes such as oral administration, sublingual injection, intravenous injection, acupoint injection, rectal drip administration, intramuscular injection, and subcutaneous injection.
  • the generating device further includes:
  • the power supply is used to provide electrical energy to the generating device
  • the spatial electric field contacting the electrode does not affect the selection of the position of the different electrode or the electrification situation.
  • the position of the different electrode and/or the performance of the spatial electric field are confirmed according to the target site, target concentration and/or dosage.
  • the power supply is a high-voltage output power supply.
  • the power supply is a high-voltage output power supply formed by a battery or a direct current power supply DC through an AC excitation step-up transformer of an oscillating circuit.
  • the voltage of the power supply is adjustable from 0.001kV to 120kV
  • the current output is from 0.001mA to 10000mA
  • the working distance of the electric field is from 0.1cm to 100cm.
  • the voltage is taken according to the depth of action and the distance of the electric field; and/or the current is adjusted according to the limit that the living body to be tested can tolerate.
  • the present invention also provides the use of the aforementioned electric field positioning drug delivery device in any one or more of the following: (1) positioning drug delivery; (2) enriching metal ions.
  • the drugs or medicaments for targeted administration include but are not limited to ionic (cationic, anionic) reagents and neutral reagents (ion exchange or ionization treatment before use).
  • the present invention also provides a method for controlling the movement trajectory of the ionic preparation in vivo.
  • the method at least includes the following steps:
  • Adjust and control the performance of the space electric field including one or more of electric field strength, electric field direction, electric field pulse frequency, and electric field range, and control the movement trajectory of the charged agent in the living body.
  • equipotential contact point may be the sole of the foot as shown in FIG. 1, or may be other parts of the living body to be tested, or be moisturizing, conductive grease, or the like.
  • the living body to be tested is a living animal body. Further, it is a mammal.
  • the mammals are preferably rodents, artiodactyls, odd-hoofed animals, lagomorphs, primates and the like.
  • the primates are preferably monkeys, apes or humans.
  • the spatial electric field contact electrode is grounded.
  • the external electrode of the spatial electric field may be in contact with the living body to be measured, or may not be in contact with the living body to be measured.
  • the different electrode is a point probe.
  • the charged agent is concentrated at the position where the electric field acts.
  • the charged agent is a charged agent.
  • the charged medicament is one or more of charged injection medicament, charged oral medicament and charged rectal administration medicament.
  • it includes, but is not limited to, charged medicaments suitable for oral administration, sublingual injection, intravenous injection, acupoint injection, rectal drip administration, intramuscular injection, subcutaneous injection, etc.
  • the ionic reagent moves in the direction of the outer electrode of the spatial electric field.
  • the generating device further includes:
  • the power supply is used to provide electrical energy to the generating device
  • the spatial electric field contacting the electrode does not affect the selection of the position of the different electrode or the electrification situation.
  • the position of the different electrode and/or the performance of the spatial electric field are confirmed according to the target site, target concentration and/or dosage.
  • the power supply is a high-voltage output power supply.
  • the power supply is a high-voltage output power supply formed by a battery or a direct current power supply DC through an AC excitation step-up transformer of an oscillating circuit.
  • the voltage of the power supply is adjustable from 0.001 kV to 120 kV
  • the current output is adjustable from 0.001 mA to 10000 mA
  • the working distance of the electric field is adjustable from 0.1 cm to 100 cm.
  • the voltage is selected according to the depth of action and the distance of the electric field; and/or the current is adjusted according to the limit that the living body to be tested can tolerate, and the range of positioning and administration includes the area covered by the spatial electric field. But it is not limited to the area covered by the spatial electric field.
  • the electric field generating device is the aforementioned electric field positioning drug delivery device.
  • the contact electrode refers to the spatial electric field contact electrode
  • the external electrode refers to the spatial electric field external electrode.
  • Table 1 Summary of electric field intensity parameters and pre-experimental weights of experimental animals
  • the rat was fixed on a flat plate in the supine position, and after observing that the rat had no righting reaction, the rat was weighed, and 10% chloral hydrate was taken to anesthetize the rat in an amount of 0.3ml/100g.
  • sublingual intravenous injection of verapamil was performed at a dose of 1.0 mg/kg (about 300 ⁇ g/rat: according to the equivalent dose coefficient conversion algorithm in "Pharmacological Experiment Methodology" edited by Professor Xu Shuyun, the injection dose was 6 times the normal human dose.
  • Table 2 Electric field intensity parameters and verapamil dosage of experimental animals in the group
  • the rats were sacrificed, and the heart, liver and kidneys of the rats were taken out, quick-frozen with liquid nitrogen, and then reserved for use (for measuring the concentration of verapamil).
  • verapamil standards were made into standard series solutions with concentrations of 1, 3, 10, 30, 100, and 300 ng/mL.
  • Phase A is 5mM ammonium acetate 0.2% formic acid aqueous phase
  • Phase B is acetonitrile, 2min 60% B isocratic elution
  • flow rate 0.8mL/min
  • Column temperature 40°C
  • Injection volume 10 ⁇ L.
  • SPSS17.0 software was used for data analysis.
  • the experimental data are expressed as mean ⁇ standard deviation.
  • the t test is used, the independent sample t test is used for comparison between groups, and the paired sample t test is used for comparison within groups ;
  • the rank sum test is used for comparison. P ⁇ 0.05 was considered as statistically significant.
  • the dosing box Before the start of administration, the dosing box should be positively charged for 15 minutes to add positive charges to the drug, and to ensure that the dosing box is always connected to the positive charge during the electric field administration period.
  • the experimental animals (5 in each group) were euthanized and blood was collected, and the heart, liver and kidney were taken out.
  • the content of verapamil in each tissue was counted.
  • Group G did not implement electric field administration, and injected the drug directly into the heart. 1 hr after the start of administration, about 1/3 of the dose remained in the heart, 1/3 of the menstrual blood remained in the blood components, and the rest was mainly excreted through the kidneys Excreted from the body.
  • the cationic preparation adopts the electric field administration mode described in the patent, which is expected to replace the existing traditional administration mode of intravenous or direct injection into the affected area. While avoiding the additional pain caused by the physical puncture to the patient, with the reduction of the dosage of the medicine, the medical resources and the medical expenditure and medical insurance cost of the patient's own burden are saved.
  • Table 4 Distribution of anionic agents of verapamil after 1 hr of administration

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne un procédé pour commander le mouvement ou la position d'une substance dans un corps vivant. Ledit procédé comprend au moins les étapes suivantes consistant à : 1) placer un corps vivant dans un appareil de génération de champ électrique, l'appareil de génération de champ électrique comprenant une électrode de contact et une électrode externe, et l'électrode externe comprenant une ou plusieurs hétéro-électrodes, la position de l'hétéro-électrode étant réglable ; 2) permettre au corps vivant d'être en contact avec l'électrode de contact de sorte qu'un équipotentiel soit formé entre le corps vivant et l'électrode de contact ; et 3) ajuster les performances du champ électrique de façon à commander le mouvement d'au moins une substance dans le corps vivant ou à commander la position de la ou des substances dans le corps vivant. Selon la présente invention, un champ électrique peut agir sur une substance chargée dans un corps vivant, de telle sorte que la substance chargée se déplace d'une manière prédéterminée ou soit évacuée du corps vivant ; et le champ électrique peut agir sur des cellules tumorales, des médicaments dans un organisme, de l'eau dans l'organisme, des nerfs dans l'organisme, des ions de métaux lourds dans l'organisme et des ions dans l'organisme, et agir sur un processus de réaction chimique de façon à commander une séquence de réaction, catalyser et empêcher la réaction de certaines substances, etc.
PCT/CN2020/086399 2019-04-23 2020-04-23 Procédé et appareil pour commander le mouvement ou la position d'une substance dans un corps vivant Ceased WO2020216290A1 (fr)

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