WO2007125699A1 - Systeme de distribution de medicament et programme informatique pour commander le systeme de distribution de medicament - Google Patents

Systeme de distribution de medicament et programme informatique pour commander le systeme de distribution de medicament Download PDF

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Publication number
WO2007125699A1
WO2007125699A1 PCT/JP2007/055808 JP2007055808W WO2007125699A1 WO 2007125699 A1 WO2007125699 A1 WO 2007125699A1 JP 2007055808 W JP2007055808 W JP 2007055808W WO 2007125699 A1 WO2007125699 A1 WO 2007125699A1
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WO
WIPO (PCT)
Prior art keywords
drug
magnetic
magnetic field
blood vessel
retention amount
Prior art date
Application number
PCT/JP2007/055808
Other languages
English (en)
Japanese (ja)
Inventor
Norihide Saho
Akira Sasaki
Kenichi Kawabata
Hisashi Isogami
Hiroyuki Tanaka
Original Assignee
Hitachi Medical Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hitachi Medical Corporation filed Critical Hitachi Medical Corporation
Publication of WO2007125699A1 publication Critical patent/WO2007125699A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/73—Manipulators for magnetic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5094—Microcapsules containing magnetic carrier material, e.g. ferrite for drug targeting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A61B34/73—Manipulators for magnetic surgery
    • A61B2034/731—Arrangement of the coils or magnets
    • A61B2034/733—Arrangement of the coils or magnets arranged only on one side of the patient, e.g. under a table

Definitions

  • the present invention relates to a drug delivery system utilizing magnetism, and more particularly to a new drug delivery system for efficiently guiding a magnetic drug to an affected area.
  • a drug for destroying cancer cells, preventing growth of cancer cells, or preventing metastasis of cancer cells is used as a dosing means such as a syringe or the like in a blood vessel of a subject.
  • the dosing means is constituted by an elongated catheter, and the elongated catheter is inserted, for example, from a blood vessel in the thigh, and the inside of the blood vessel is obtained by a two-dimensional or three-dimensional in-vivo imaging device such as MRI (nuclear magnetic resonance imaging).
  • the catheter's tip is pushed forward in a given direction in the direction of the blood vessel bifurcation while the catheter tip is moved from outside the subject, and the catheter near the cancer cells located at the end of the blood vessel circuit network.
  • Patent Document 1 includes a stage for fixing a part or the whole of a living body in a magnetic field space and, for example, a coil type superconducting magnet for providing the magnetic field space disposed around the stage,
  • a system has been disclosed which controls the position space distribution of a drug by providing the distribution of magnetic field maxima or minima in an affected area in a living body by three-dimensionally controlling a magnet.
  • a liquid film jelly-like nonmagnetic drug is caused to stay by magnetic force by being enclosed in a capsule in a magnetic gradient generated by a superconducting magnet.
  • Patent Document 2 As another drug delivery system utilizing magnetic force, as disclosed in Patent Document 2, for example, a drug and a magnetic particle are combined, and a magnetic drug is injected into a blood vessel of a subject.
  • the medicine is placed in a container, a magnet is placed near the cancer cells of the subject, and the magnetic drug that happens to pass through the magnetic field is captured by magnetic force by the blood circulation circulating in the subject's body.
  • a thin tube and a catheter are inserted into the blood vessel of the predetermined site, and an MRI apparatus and X-ray CT The catheter will be advanced while confirming the tip position of the catheter with the device.
  • Patent Document 1 Japanese Patent Application Laid-Open No. 2000-229844
  • Patent Document 2 Japanese Patent Application Laid-Open No. 09-328438
  • the stiffness of the catheter traveling through the blood vessel is considerably larger than that of the passing blood vessel, and therefore, the catheter is deformed depending on the shape of the catheter. For this reason, the three-dimensional position of the blood vessel bifurcation point differs before and after the insertion of the force table. Therefore, in order to control the moving direction of the catheter tip at the bifurcation point of the blood vessel, an MRI apparatus or X-ray CT The device must always detect both tip and vessel bifurcation position information. Such control is cumbersome and very inefficient.
  • the catheter can not pass through a blood vessel having a diameter smaller than the diameter of its tip. Can not guide the catheter up. Therefore, there is a problem that it is not possible to detect how much the dosed medicine remains at the blood vessel bifurcation, and it can not be determined whether the necessary amount remains in the affected area. This makes it impossible to know if the proper amount of drug has been administered.
  • the present invention has been made in view of such problems, and it is intended to prevent the formation of thrombus in blood vessels while confirming the position of the magnetic drug to the details of the body by magnetic force.
  • the present invention provides a magnetic dosing guidance system capable of precisely guiding the magnetic drug to the affected area.
  • the present invention places a part or the whole of a living body on a stage, injects a drug having a magnetic substance injected into the living body, and guides it to the affected part of the living body.
  • a delivery system is provided.
  • This drug delivery system comprises a blood vessel information acquiring means for acquiring blood vessel information including the position of a blood vessel bifurcation in a living body, and a magnetic field for generating a magnetic field for guiding movement of a drug in the blood vessel of the living body by magnetic force.
  • a control means for controlling the magnetic field generation means to be disposed at the blood vessel bifurcation based on the blood vessel information; and a retention amount detection means for detecting the retention amount of the drug at the blood vessel bifurcation; And adjusting the magnetic force of the magnetic field generation means in accordance with the amount of retention of the drug detected by the amount-of-stop detection means.
  • the drug of magnetic substance has a substance that causes an acoustic impedance difference
  • the means for detecting the staying amount is an ultrasonic probe, and the drug impedance is detected by detecting the acoustic impedance difference of the drug. Let's detect the amount.
  • the magnetic force of the magnetic field generating means is weakened and then the retention amount of the drug The magnetic force of the magnetic field generation means is restored to its original state again when the threshold value becomes 2 or less.
  • the blood vessel route from the dosing position to the affected area is determined, and based on the information, the magnetic field generating means for supplying the magnetic field to the blood vessel bifurcation is arranged.
  • the presence of the magnetic agent is detected by ultrasonic search means at each blood vessel bifurcation.
  • a magnet arranged at a predetermined position generates a predetermined magnetic field, and the amount of magnetic drug trapped and retained at the site is After the amount of retention is measured using a probe, the magnetic force of the magnet at the branch is reduced to guide the magnetic agent to a predetermined vascular circuit.
  • the magnetic index of the magnetic drug can be controlled appropriately based on the results of measurement of the amount of trapped and fixed magnetic drug, and the magnetic drug can be precisely guided to the details of the body by the magnetic force.
  • FIG. 1 is an external view of an MRI apparatus 1 for measuring a three-dimensional vascular circuit.
  • FIG. 2 A diagram showing a three-dimensional vascular circuit of the head of a patient measured by an MRI apparatus 1.
  • FIG. 3 is a diagram showing an example in which the MRI apparatus 1, the drug delivery apparatus 100 and the database 300 are connected to a network.
  • FIG. 4 is a diagram showing the configuration of a magnetic induction drug delivery system 100 according to an embodiment of the present invention.
  • FIG. 5 is a view for explaining the structure in the superconducting magnet container 7 according to the first embodiment.
  • FIG. 6 is a view for explaining magnetic induction of a magnetic agent at a blood vessel bifurcation of a patient's head in the first embodiment.
  • FIG. 7 is a flowchart for explaining the operation of the drug delivery system 100 according to the present invention.
  • FIG. 8 is a view for explaining the structure in a superconducting magnet container 7 using a high temperature superconducting valve body according to a second embodiment of the present invention.
  • FIG. 9 is a view showing a side cross section of a high temperature superconducting valve body according to a second embodiment of the present invention.
  • FIG. 10 is a front view of a high-temperature superconducting valve body according to a second embodiment of the present invention.
  • FIG. 11 is a view for explaining magnetic induction of a magnetic agent at a blood vessel bifurcation of a patient's head in the second embodiment of the present invention.
  • FIG. 12 is a view showing a side cross section of a high-temperature superconducting valve body according to a third embodiment of the present invention.
  • FIG. 13 is a front view of a high-temperature superconducting valve according to a third embodiment of the present invention.
  • FIG. 1 shows the appearance of a nuclear magnetic resonance imaging (MRI) apparatus 1 using, for example, a superconducting magnet or a permanent magnet.
  • the MRI apparatus 1 is generally used to image a cross section of the patient 2 in the body.
  • a contrast medium containing weak magnetic particles is injected into the blood vessel of the patient 2, and the blood is detected by detecting the contrast medium mixed in the blood. The image is taken, and from this information the blood flowing blood vessels are imaged in detail.
  • FIG. 2 shows an example of a blood vessel image imaged by the MRI apparatus 1 and is a projection two-dimensional image of a three-dimensional image of the blood vessel group 4 connected to the head 3 of the patient 2.
  • the blood flow from the trunk part is divided into two directions and flows into a predetermined part of the head.
  • the drug delivery system it is important for the drug delivery system according to the present embodiment to obtain information (position, angle of branch, shape of branch, etc.) related to such a branch.
  • the imaged blood vessel information is sent to the processing unit 10, and is stored in a memory, not shown, provided in the processing unit 10.
  • the MRI apparatus 1 may be connected to the drug delivery system 100 and the database 300 according to the present embodiment via a local area network (LAN) 200.
  • LAN local area network
  • the patient's blood vessel information acquired by the MRI apparatus 1 is transmitted to the database 300 via the LAN 200 and stored.
  • the network may be the Internet, a wireless network or the like besides the LAN.
  • FIG. 4 is a schematic view showing the configuration of a drug delivery system 100 according to the present embodiment.
  • the drug delivery system 100 uses magnetism to guide a magnetic drug to the affected area of the patient 2 and checks whether it can be properly guided using ultrasound.
  • the arithmetic and control unit 70 acquires blood vessel route information of the patient 2 measured by the MRI apparatus 1 and stored in the database 300, and communicates the magnetic drug injection position to the affected area. Check the vascular route.
  • a method of acquiring blood vessel route information to the affected area of the patient 2 will be described. First, after the affected area has been identified (specifically, imaging is performed by imaging the patient with an MRI apparatus, an X-ray CT apparatus, an X-ray imaging apparatus, etc.), the doctor sends an imaging diagnostic device to the technician.
  • the engineer who received a request for 3-dimensional blood flow imaging from a doctor goes to sleep on patient 2 in MRI apparatus 1.
  • the patient 2 is positioned on the measurement space of the magnetic field generator so that the region from the heart to the affected area can be imaged as an ROI (Region of Interest) on a table.
  • a pulse sequence for three-dimensional blood flow imaging is selected to prepare for MR imaging. Since a pulse sequence for three-dimensional blood flow imaging only needs to be able to extract blood vessels from the heart to the affected area and draw blood vessel bifurcations between them, patients with MR contrast media containing cadmium prior to imaging 2 It may be injected into or without injection.
  • the R ⁇ I of three-dimensional blood flow imaging is the maximum of the MRI apparatus 1 If it exceeds F ⁇ V, it is necessary to divide the imaging several times.
  • imaging techniques such as the Manolechi Station MRA method and the MOTSA (Multi-overlapping thin trac- ance acquisition) method can be used.
  • imaging parameters are set, and for controlling the position of the magnet on the surface of the patient 2's body.
  • This marker consists of a medium that is suitably sensitive to the magnetic resonance phenomenon, for example, a thin tubular body enclosing water, and a position information transmitter coupled to the tubular body.
  • the position information transmitter can use, for example, a magnetic sensor or an optical sensor, a magnetic transmitter or an infrared transmitter.
  • the tubular body in which water is enclosed is within the FOV of MR imaging, and when the patient is viewed planarly (synonymous with imaging in the supine position), the blood vessel, affected area and tubular body to be imaged. Are placed in such a way as to be superimposed on the three-dimensional bloodstream image.
  • Extraction of the blood vessel bifurcation is performed based on this three-dimensional blood flow image.
  • the three-dimensional blood flow image of the patient 2 obtained by the MRI apparatus 1 is sent to an image analysis apparatus built in the operation console of the MRI apparatus 1 and displayed on the display screen.
  • the real space seat of the magnetic induction drug delivery system to 3D blood flow image A three-dimensional coordinate system orthogonal to the target system is given.
  • the vascular system and the like connected to the heart and the affected area are specified and extracted on the three-dimensional blood flow image.
  • Identification and extraction of this vascular system are performed by the doctor visually observing the 3D blood flow image displayed on the display and operating the pointing device such as a mouse in the displayed 3D blood flow image.
  • This can be realized by designating the blood flow region between the designated two points by a known region extraction method, for example, the region expansion method.
  • the bifurcations identified here are targets for magnet positioning.
  • Extraction of blood vessel bifurcation can be performed as follows. For example, it is based on a method in which the doctor extracts the bifurcation of the blood vessel while observing the three-dimensional blood flow imaging displayed on the display of the image analysis device. In this case, extraction of the bifurcated portion of the blood vessel is performed by the doctor visually observing a three-dimensional blood flow image and inputting a cursor or coordinate point or the like to the bifurcated portion with a mouse or the like.
  • the vascular route information of the patient 2 acquired as described above is stored in the database 300.
  • the arithmetic and control unit 70 determines the magnetic field strength, the position, the angle, etc. of the superconducting magnet at each of a plurality of branch parts of the blood vessel included in the determined blood vessel route. Then, the arithmetic and control unit 70 holds the superconducting magnet container 7 containing the superconducting magnet for generating a predetermined magnetic field at the tip of the magnet container position control unit 8, based on the determined contents. The magnet part at the tip is arranged while adjusting the excitation power supply to the determined predetermined three-dimensional position, the determined angle, and the determined magnetic field strength.
  • the injection of the magnetic drug is performed to the blood vessel at a predetermined site (for example, the thigh) using a syringe or the like.
  • the magnet container position control device 8 is controlled by the arithmetic control device 70, for example, by a wireless signal.
  • the magnet container position control device 8 is positioned at a predetermined position of a car 12 which is rotationally driven by a drive unit storage box 11 having a motor (not shown) on the movable base 10 in the vicinity of a bed 9 on which a patient 2 is placed.
  • the magnet container position control device 8 is a rotary motor at the upper part of the support column 99
  • Each superconducting magnet container 7 is operated by operating the rotary drive unit 13 (not shown), the arm 14, the revolute joint 15, the arm 16, the revolute joint 17, the arm 18 and the superconducting magnet container holder 19. Is set to the desired three-dimensional position and angle.
  • a helicopter compressor 29 and an excitation power supply (not shown) shown in FIG. 5 described later are disposed in the drive unit storage box 11 and high pressure piping 30, low pressure piping 31, excitation power supply, power lead wire 45 columns.
  • a protection tube 46 made of a bellows-like polymer material After passing through the rotary drive part 13 in and above 99, it is bundled and flexible, for example, housed in a protection tube 46 made of a bellows-like polymer material, and connected to the superconducting magnet container 7 There is.
  • a protective tube (not shown) is passed through and held in a support ring 47 mounted on the arm.
  • FIG. 5 is a view showing the configuration of the superconducting magnet container 7.
  • a core wire of a high-temperature superconducting conductor mainly composed of YBCO is coiled in a large number in a coil form on the outside of a copper bobbin 20 having a diameter of about 25 mm to form a solenoidal magnet 21. Fix by fixing with adhesive etc. between coil wire and bobbin by immersion.
  • the bobbin 20 is thermally integrated on a heat transfer flange 22 made of, for example, copper via a soft sheet having a large thermal conductivity such as in-geum through the heat transfer flange 22 via a bolt (not shown) or the like. ing.
  • the heat transfer flange 22 is airtightly joined to the cylindrical body 23 made of, for example, stainless steel having a small thermal conductivity by welding or silver solder so as to be vacuum airtight, and the other end is airtightly joined to the flange 24 by welding or the like.
  • the flange 24 is airtightly fixed to the room temperature flange 25 by an o-ring and a bolt (not shown).
  • the refrigerator fixing flange 26 is metallurgically and airtightly integrated with the room temperature flange 25, and the refrigerator fixing flange 26 and the gas flow path switching mechanism of high pressure gas and low pressure gas via the vacuum tight bellows 27
  • a Hefford 'McMahon-type helium refrigerator head 28 containing a not shown is airtightly fixed by an O-ring and a bolt (not shown).
  • the helium refrigerator head 28 is connected to a high pressure helium gas pipe 30 and a low pressure helium gas pipe 31 from a helium gas compressor 29.
  • Connected to the head 28 of the helium refrigerator is a cylinder 32 for adiabatic compression and expansion of helium gas and a cold stage 33 of a cold generation part.
  • a vacuum vessel cover 34 is disposed on the outer periphery of the solenoid magnet 21 for vacuum insulation, and the vacuum vessel cover 34 is a flange 35, and an airtight ring is fixed to the flanges 24 and 25 by a ring (not shown). Be done.
  • the solenoid magnet 21, the heat transfer flange 22, and the cold stage 33 which have a temperature of about minus minus 230 degrees Celsius, laminated radiation is applied around the room temperature component to prevent radiation heat from entering. Heat insulation 36.
  • Spaces 37, 38 are evacuated by vacuum pump 39 through vacuum piping 40, valve 41, vacuum piping 42, and valve 43 to form a vacuum adiabatic space. After being cryogenically cooled by the refrigerator, the valves 41 and 43 can be closed to separate the superconducting magnet container 7 and the vacuum pipes 40 and 42.
  • the helium refrigerator is pressed against the heat transfer flange 22 by atmospheric pressure, and heat conduction between the cold stage 33 and the heat transfer flange 22 such as an engine sheet or grease is generated. A medium is applied, and the heat transfer flange 22 is well cooled by the cold of the cold stage 33 by the pressing force.
  • the helium refrigerator is operated while evacuating the spaces 37 and 38, and after the superconducting magnet 21 is cooled to a very low temperature, the exciting power supply 44 supplies power to the superconducting magnet 21 through the power lead wire 45.
  • a magnetic field of, for example, 5 Tesla can be generated continuously in the center of the solenoid of the superconducting magnet 21.
  • the magnetic field distribution is as shown in FIG. 6, and the magnetic field strength is strongest near the outer periphery of the tip of the superconducting magnet container 7 near the affected area, and the magnetic gradient in the axial and radial directions of the magnet is also near the outer periphery. Becomes larger. Therefore, the magnetic force is large even in the vicinity of the outer periphery.
  • the flange 24 and the flange 35 are integrated with the flange 25 independently with the bolt (not shown), and the component members associated with the two flanges are integrated as one flange. Since various types of superconducting magnets 21 with different diameters, magnet axial lengths, magnetic field strengths, etc. are manufactured, superconducting magnets 21 of the required specifications can be used in combination with a helium refrigerator, and the refrigerator can be shared It can reduce the cost of magnetic and ultrasound guided drug delivery systems.
  • Each superconducting magnet container 7 having the above-described configuration and set at a desired position is disposed at each branch portion 5 as shown in FIG.
  • the magnetic field ⁇ ⁇ generated by the superconducting magnet in the superconducting magnet container 7 as the magnetic field generating means is from inside the skin of the patient 2 Penetrate and reach the bifurcation 5 of the blood vessel 2.
  • the magnetic field strength and the magnetic field gradient on the side of the branch blood vessel a become large in the branch blood vessel a and the branch blood vessel b of the blood vessel 2.
  • the attraction magnetic force on the side of the branch vessel a on the magnet installation side acting on the magnetic drug particles 6 flowing into the branch part 5 along the blood flow indicated by the arrow is larger than that on the side of the branch vessel b. Acting on the side, most of the magnetic drug particles 6 are controlled to flow into the branched blood vessel a.
  • the magnetic drug particles themselves play the role of a magnet and capture another magnetic drug particle. If the number of magnetic drug particles to be captured increases, there is a risk of causing a thrombus in the vicinity of the bifurcation 5.
  • the amount of retention of the magnetic agent in the vicinity of the branch portion 5 is monitored using the ultrasonic probe 48, and based on the monitoring result, the magnetic field strength of the superconducting magnet is determined. It is a form of wholesale and wholesale.
  • the ultrasonic probe 48 moves from the location of the blood vessel bifurcation group to the position where the magnetic agent is located at the upstream branch, on the movable platen 49,
  • the vehicle 12 is driven to rotate by a drive storage box 50 having a motor (not shown), and moved to a desired position (a position where the tip of the ultrasonic probe is directed to the branch 5).
  • a three-dimensional position to the blood vessel bifurcation by a rotary drive unit 52 incorporating a rotary motor (not shown) at the top of the support 51, an arm 53, and an ultrasonic probe holder 54 having a rotation function.
  • the arrangement of the ultrasonic terminal element 48 is preferably set at a position where the detected image can be clearly recognized.
  • the ultrasonic probe 48 can measure a quantitative value of the amount of magnetic agent based on the magnitude of the reflection of the ultrasonic wave because of the difference in the acoustic impedance of the magnetic agent.
  • the measurement result of the amount of retention of the magnetic agent measured by the ultrasonic probe 48 is connected with the ultrasonic diagnostic apparatus 56 by the signal wiring 55, and the data is transmitted by the cable 57 to the arithmetic and control unit 70. If the capture and retention of the magnetic agent at the bifurcation of the blood vessel occurs based on the measurement results, the amount of retention should be greater than a predetermined amount.
  • the magnet for magnetic induction is moved away from the blood vessel bifurcation, and the excitation power of the magnet is turned off to reduce the magnetic force of the relevant site, Induced by the bloodstream.
  • the magnetic induction magnet is returned to the state of the base, and the magnetic drug to be circulated is further induced.
  • the ultrasonic probe 48 can be moved to the blood vessel bifurcation further downstream to measure the amount of trapped and retained magnetic drug.
  • a drug having a magnetic substance is added with a density difference generator for generating a substance that generates an acoustic impedance difference due to the addition or external stimulation of an object having an acoustic impedance difference with blood, a magnetic field is generated.
  • Means An object at a branch point in the magnetic field is detected by the ultrasonic probe 48.
  • the magnetic drug particle or the micro bubble group in which nitrogen gas bubbles having a size of several microns or less or a micro bubble group such as helium gas are added to the magnetic drug particles at the time of injection into the body or in advance.
  • Magnetic colloid particles containing magnetic drug particles, and magnetic colloid particles containing magnetic particles and a drug can be used. Then, the magnetic colloid particles are induced to the branch portion 5 leading to the affected area of the cancer cell by the magnetic particle induction system.
  • the magnetic field of the magnet is larger than the calculation, the position of the magnet is closer to the branch point than the calculation, the amount of the magnetic particles of the magnetic drug particles is large, and If the stronger magnetic force is greater than the calculated value, it is possible that the magnetic agent is trapped on the inner wall of the blood vessel at the bifurcation, and the magnetic agent is not induced beyond that.
  • ultrasonic detection means (ultrasound probe 48) is provided on the patient's body surface near each branch point by ultrasonic generation, and the branch portion 5 where a magnetic field is present is searched by ultrasonic waves that are not affected by the magnetic field. Thus, it is detected whether or not the magnetic colloid particle group is captured.
  • an ultrasonic impedance of a frequency that induces foaming before irradiation is emitted to the branch point, whereby an acoustic impedance difference is generated in the magnetic colloid particle group. It is also possible to generate the substance possessed.
  • the drug by ultrasonic vibration To briefly describe the principle of phase shift and change to the gas phase, a phase change is caused by resonating liquid phase particles by applying ultrasonic vibration to the particles. As a result, the acoustic impedance can be changed.
  • the ultrasonic imaging apparatus is constituted by a sensor unit 48 and an image diagnostic apparatus 56, and is an apparatus for visualizing a reflection echo generated by a difference in acoustic impedance by pulse transmission.
  • a wave to be applied to the ultrasonic transducer as a burst wave, it is possible to change particles from the liquid phase to the gas phase and generate a microbubble group to make an image.
  • an ultrasonic probe is used according to the density difference.
  • the position of the magnetic drug can be detected by the feeler 48).
  • magnetic force is generated by the magnetic field for magnetic induction also to these micro bubble groups, and it acts in the same magnetic force direction as the medicine having the magnetic substance to increase the magnetic force and improve the better induction function. Can be expected to be effective.
  • the ultrasonic diagnostic apparatus can detect and confirm how much the magnetic colloid particles are trapped and retained in the blood vessel wall of the blood vessel bifurcation.
  • the magnetic drug is appropriately induced to the affected area by moving predetermined magnetic generation means away from the branch point in order to separate the magnetic colloid particles from the blood vessel wall based on the information, and the accumulation rate of the magnetic drug in the affected area. Can be detected. Therefore, the end of the operation of the magnetic induction type drug delivery system 100 is judged by the accumulation rate of the magnetic drug, and the signal for stopping the system after reaching the predetermined accumulation rate is an alarm, a color lamp, and a display screen of the control computer. Can be displayed. This has the effect of being able to inform the driver engineer of the appropriate shutdown information.
  • FIG. 7 is a flowchart for explaining the operation of the drug delivery system. Note that, unless otherwise specified, the control entity in each step is the arithmetic and control unit 70.
  • step S101 blood vessels such as blood vessel images (three-dimensional) up to the affected area of the target patient are Get information.
  • the information on the blood vessel is captured in advance by the MRI apparatus 1 or the XCT apparatus, and stored in the database 300 via the LAN 200 (see FIG. 3).
  • step S102 relative three-dimensional positional information of the plurality of branch parts 5 present in the blood vessel is acquired from the information of the blood vessel acquired in step S101.
  • This position information is coordinate information obtained by using the predetermined position of the patient's body as the base point (for example, with the position of the patient's own body as the origin) calculated by the MRI apparatus 1 or the like.
  • This position information includes the position, shape, angle, blood vessel diameter, etc. of the blood vessel bifurcation.
  • the flow rate at each branch of blood is also determined by the MRI apparatus 1 as other information. These pieces of information are stored, for example, in the database 300.
  • step S103 the shape of the magnet required at each branch and the magnetic field (magnetic field) characteristic of the magnet are acquired.
  • the magnet shape and magnetic field characteristics are linked to the shape of the bifurcation and the depth in the body, but for example, the database 300 seems to be optimum in accordance with the bifurcation shape, the diameter of the blood vessel, and the blood flow velocity.
  • Information on magnet shapes and magnetic field characteristics is stored as past statistical data, and information on magnet shapes and magnetic field characteristics is extracted from this database in response to information such as branch shape.
  • step S104 based on the information acquired in step S103, a plurality of available magnet systems (superconducting magnet container 7) are prepared at present and used at each branch point. Select the magnet system to be In addition, the three-dimensional arrangement position and the angle of arrival from the base point of each branch are set so that the magnet system can be optimally assigned to each branch.
  • the address S may be, for example, a value statistically determined according to the shape and depth of the branch portion as described above, or may be determined according to a predetermined calculation from the shape of the magnet and the magnetic field characteristics. Also good.
  • step S105 whether the target patient has been placed at a predetermined position on the delivery system stage (stage), that is, the system origin (coordinate origin) and the patient origin when imaged by the MRI apparatus. It is judged whether and are matched. The process does not move to the next step until it is placed at the predetermined position.
  • step S106 the magnet system is set to the position and angle obtained in step S104. Furthermore, in step S107, the ultrasound probe 48 is set in the vicinity of each branch portion and in the vicinity of the affected area.
  • the ultrasound probe 48 is set in the vicinity of each branch portion and in the vicinity of the affected area.
  • the branch from the affected area to the most upstream branch is set first, and for the other branches, the three-dimensional coordinates of each branch and the destination angle are temporarily set. It may be stored in the memory, and monitoring of each branch may be performed while sequentially shifting to the downstream branch as soon as monitoring at the upstream branch ends.
  • step S108 it is determined whether the magnet system (superconducting magnet container 7) and the ultrasound probe 48 have been set to appropriate positions. Whether or not the position is correct is determined, for example, based on whether the information acquired in step S1044 matches the set position 'angle. If it is determined in step S108 that the position has been set to the proper position, the process proceeds to step S109, and if it is determined that the position has deviated from the proper position, the magnet system and the ultrasound probe are Reset the position or fine-tune the position and angle.
  • step S109 notification of permitting the injection of the magnetic agent (for example, display on the display unit or notification by voice) is performed, and when it is detected that the magnetic agent is injected by the operator such as a doctor (for example, At the same time as the injection, the operator depresses the operation switch) and the induction operation of the magnetic drug is started.
  • the operator such as a doctor
  • step S110 the amount of retention of the magnetic agent at each of the bifurcated portions / the affected area is monitored by the ultrasonic element 48, and the amount is managed one by one.
  • step S 111 the amount of retention of the magnetic agent at the branching portion after a predetermined time has elapsed is compared with the first threshold to determine whether the amount of retention exceeds the first threshold.
  • This first threshold is determined based on, for example, the amount at which there is a risk of thrombus formation at the bifurcation. Therefore, since the risk of thrombus varies among individuals depending on the physical constitution, age, etc., it is possible to read out the first threshold value also from the database 300 using a statistical method. .
  • step S111 when the amount of stationing does not reach the first threshold value, the process proceeds to step S117, and when it has reached the process, the process proceeds to step S112.
  • the magnet system is controlled to weaken the generated magnetic force.
  • Ru This control is performed, for example, by moving the magnet portion of the magnet system away from the branch or lowering the magnet current value for generating a magnetic field.
  • step S113 the staying amount of the magnetic agent at the branch portion is continuously monitored by the ultrasonic probe 48, and it is determined whether the value becomes equal to or less than a second threshold.
  • This second threshold is an amount that eliminates the risk of thrombus formation, and has individual differences similar to the first threshold. If the retention amount of the magnetic agent is not less than or equal to the second threshold, the process repeats step S112 to continue weakening the magnetic force of the magnet system. On the other hand, when the amount of stationing falls below the 2nd threshold, processing shifts to Step S114.
  • step S114 the magnetic force generated by the magnet system is restored, and induction operation is continued again.
  • step S 115 the amount of retention of the magnetic agent in the affected area after a predetermined time has elapsed is detected, and it is determined whether the amount of retention is greater than or equal to a third threshold.
  • the third threshold indicates an amount sufficient to exert the efficacy of the magnetic agent in the affected area, and varies depending on the type of the magnetic agent. If the amount of retention of the magnetic drug in the affected area has not reached the third threshold or higher, it is highly likely that the magnetism itself has been digested by the liver, so it is necessary to determine whether it is possible to inject the magnetic drug again.
  • the processing shifts to step S117. On the other hand, if the retention amount reaches the third threshold value or more, the process proceeds to step S116.
  • step S116 since the magnetic agent can be properly induced to the affected area, the induction operation of the delivery system 100 ends.
  • step S111 if the staying amount of the branch portion does not reach the first threshold, or if the staying amount at the affected part does not reach the third threshold in step S115, step S117.
  • the number of magnetic drug injections is checked at. If the number of magnetic drug injections exceeds the predetermined number (the number may differ depending on the type of magnetic drug), the burden on the human body (liver) of the target patient will increase, so if the predetermined number is reached, the process will At step S116, the induction operation of the magnetic drug is ended. On the other hand, when the number of injections has not reached the predetermined number, the process proceeds to step S109, and the processes of steps S110 to S117 are repeated thereafter.
  • one or more components of the blood vessel circuit are required. Based on the information on the magnetic susceptibility of the magnetic drug to be added, the volume, etc., the three-dimensional position of the blood vessel at each bifurcation point, the size of the blood vessel, and the blood flow velocity, the position and angle of the magnet that can generate a predetermined magnetic field are calculated. Then, place a magnet at the desired position, generate a predetermined magnetic field at multiple branches 5 and perform induction, while holding the amount of magnetic agent trapped and retained at that site using the ultrasonic probe 48. After the measurement, the magnetic force of the magnet at the bifurcation can be reduced to guide the magnetic drug to a predetermined vascular circuit. Therefore, the induction rate of the magnetic drug to a specific affected area can be increased, and the control of the magnetic force of the magnet can be appropriately performed based on the measurement result of the trapped and fixed amount of the magnetic drug. It can be guided to the affected area.
  • the magnetic drug is induced in a predetermined direction at the branch part of the blood vessel, rather than concentrating the magnetic field directly on the affected part. This can improve the drug magnetic induction rate.
  • a small solenoid coil type magnet it is possible to increase the induction rate of the input amount of the magnetic drug particles to the affected part of a specific cancer cell.
  • the magnetic field that can be generated by a permanent magnet is at most 1 Tesla, and the generated magnetic field does not reach far from the magnet surface. For this reason, when placing a magnet on the surface of the subject's body outside, the magnetic field does not reach deep from the surface outside the body, and when cancer cells are deep from the surface outside the body, the magnetic drug can not be captured. The effect may not work.
  • the magnetic force can not be concentrated, and for example, at the branch point of the blood vessel, the difference in magnetic force is hard to be added in the direction of movement, and the magnetic drug can not be induced. For this reason, it may not be possible to transport the magnetic drug while maintaining a high concentration to the cancer cells in the affected area, and in some cases it may not be possible to expect sufficient medicinal effects.
  • FIG. 8 is a view showing the configuration of a superconducting magnet container 7 according to a second embodiment.
  • FIG. 8 shows a configuration for directly cooling the high temperature superconducting valve body 58 with a small refrigerator using a YBCO high temperature superconducting valve body 58 instead of the solenoid coil 20 in the first embodiment as a magnetic field generating means. There is.
  • the outer periphery of the high temperature superconducting valve body 58 is integrated with a ring 59 made of stainless steel or aluminum dioxide with an adhesive or the like. This is to prevent a crack from being generated by the magnetic force of the high temperature superconducting valve body 58 when it is magnetized.
  • the high temperature superconducting valve body 58 and the ring 59 are thermally integrated with a heat transfer flange 60 made of copper or aluminum with an adhesive or the like.
  • the heat transfer flange 60 and the heat transfer flange 22 are thermally integrated by bolts (not shown) or the like via indice grease (not shown).
  • the method of cooling the high temperature superconducting valve body 58 by the helium refrigerator cold stage 33 is the same as the method of cooling the superconducting magnet 21 described in the first embodiment, and thus the description thereof is omitted.
  • a superconducting magnet for magnetizing which can generate a predetermined magnetic field to be magnetized, for example, a magnetic field of 10 Tesla, or Prepare separately a normal conducting magnet with a small generated magnetic field (both magnets are not shown).
  • the bulk of the magnetic field in the magnetizing magnet which already generates the magnetic field to be magnetized is reduced.
  • the body 58 is inserted, and then the high temperature superconducting valve body 58 is cooled below the superconducting temperature with a helium refrigerator.
  • the direction of the cylindrical axis of the superconducting valve body and the direction of the main magnetic field generated by the magnetizing magnet are made to coincide.
  • the magnetic field of the magnetizing magnet is demagnetized, the magnetic field is trapped in the high temperature superconducting valve body 58 which continues to be cooled, and as long as the cooling is maintained, the superconducting valve magnet becomes equivalent to the magnetizing magnetic field.
  • a high temperature superconductor having captured a magnetic field of, for example, 5 Tesla to 10 Tesla, is used as a magnetic field generating means.
  • the magnetic field distribution of the magnetized superconducting balta magnet is formed by a group of micro magnetic fluxes distributed substantially uniformly. Therefore, for example, when the high-temperature superconducting bulk body 58 is circular, the magnetic field distribution on the surface is substantially conical, and the magnetic field at the central portion is the highest.
  • the upper portion of high temperature superconducting valve body 58 has, for example, a convex shape along the three-dimensional direction of the blood vessel path to be guided of the blood vessel bifurcation.
  • High-temperature superconducting volta bodies 61 and 62 are filled with glass fiber in order to prevent the internal destruction due to the magnetic force which repels each other acting at the time of excitation of the high temperature superconducting valve body. It is supported by a resin material 63, and each is bonded and integrated. Further, the heat transfer flange 60 has fixing bolt holes 64.
  • the high temperature superconducting valve body 5 8 if the magnet central portion is set on the channel axis on the channel side to be guided at the blood vessel bifurcation that guides the magnetic agent, the high temperature superconducting valve body 5 8
  • the magnetic agent that has flowed into the magnetic field formed by the outer periphery of the magnet can naturally induce magnetic force in the direction (see FIG. 9) along the convex tip surfaces of the high temperature superconductors 61 and 62 where the magnetic field and magnetic gradient are large. .
  • more magnetic drug can be precisely induced to the predetermined vascular tract side by induction, and it is possible to further increase the induction rate of the input amount of the magnetic drug particles to the predetermined cancer cell diseased part it can.
  • the superconducting volta body in which the magnetic field and the magnetic gradient increase along the three-dimensional shape of the blood vessel circuit in the induction direction of the blood vessel branch is used as the magnetic field generating means, Furthermore, the magnetic force acting on the magnetic drug in the blood vessel can be increased, and the magnetic drug can be more surely guided to a predetermined site of the affected area, and the ratio of the magnetic drug which can be induced to the affected area is increased.
  • FIG. 12 and FIG. 13 show the configuration of the high-temperature superconducting valve according to the third embodiment.
  • a ring 66 having a groove 65 having a predetermined clearance is provided on the side surface of the section (high temperature superconducting valve body) 61 and 62, and the inside of the clearance is filled with a resin material 63 containing glass fiber. .
  • the metal ring 66 can be installed up to the vicinity of the protrusions (high temperature superconducting volta bodies) 61 and 62, the inner parts acting at the time of excitation of the high temperature superconducting volta bodies repel each other. Internal breakdown can be further prevented by magnetic force, and a larger magnetic field can be magnetized. Therefore, the magnetic force at the blood vessel bifurcation can be increased, and the proportion of the magnetic drug that can be precisely guided to the affected area can be increased.
  • the present invention can also be realized by a program code of software that realizes the functions of the embodiment.
  • a storage medium recording the program code is provided to the system or apparatus, and the computer (or CPU or MPU) of the system or apparatus reads the program code stored in the storage medium.
  • the program code itself read out from the storage medium implements the functions of the above-described embodiments, and the program code itself and the storage medium storing the same constitute the present invention.
  • a storage medium for supplying such a program code for example, a floppy (registered trademark) disk, a CD-ROM, a DVD-ROM, a hard disk, an optical disk, an optical magnetic disk, a CD-R, a magnetic tape, a non-volatile memory
  • a floppy (registered trademark) disk for example, a CD-ROM, a DVD-ROM, a hard disk, an optical disk, an optical magnetic disk, a CD-R, a magnetic tape, a non-volatile memory
  • a floppy (registered trademark) disk for example, a floppy (registered trademark) disk, a CD-ROM, a DVD-ROM, a hard disk, an optical disk, an optical magnetic disk, a CD-R, a magnetic tape, a non-volatile memory
  • ROM read-only memory
  • an OS (approval system) or the like running on a computer performs a part or all of the actual processing based on the instructions of the program code, and the functions of the above-described embodiment are performed by the processing. May be realized.
  • the CPU of the computer, etc. executes part or all of the actual processing based on the instructions of the program code. Even if the functions of the above-described embodiment are realized by the processing.
  • the storage means such as a hard disk or a memory of the system or the device or the CD-RW, CD-R, etc.
  • a program stored in a storage medium and stored by the computer (or CPU or MPU) of the system or apparatus in the storage means or the storage medium You can also achieve it by reading and executing the code.

Abstract

La présente invention concerne un système de distribution de médicament qui peut guider avec précision un médicament magnétique par une force magnétique vers une partie touchée tout en confirmant la position du médicament magnétique sur un point précis dans le corps. Dans le système de distribution de médicament, une partie ou la totalité d'un corps vivant est placé sur un support, et un médicament contenant une matière magnétique injecté dans le corps vivant est guidé vers une partie touchée du corps vivant. Dans le système de distribution de médicament, des informations concernant un vaisseau sanguin y compris la ramification d'un vaisseau sanguin dans un corps vivant, sont acquises et, en se basant sur les informations concernant un vaisseau sanguin, une commande est réalisée de manière à ce que les moyens de production du champ magnétique soient disposés sur la ramification du vaisseau sanguin. En outre, des moyens de détection de la quantité retenue destinés à détecter la quantité retenue de médicament dans la ramification du vaisseau sanguin sont prévus. La force magnétique des moyens de production d'un champ magnétique est régulée en fonction de la quantité retenue de médicament détectée par les moyens de détection de la quantité rétention.
PCT/JP2007/055808 2006-04-27 2007-03-22 Systeme de distribution de medicament et programme informatique pour commander le systeme de distribution de medicament WO2007125699A1 (fr)

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US10813997B2 (en) 2009-11-02 2020-10-27 Pulse Therapeutics, Inc. Devices for controlling magnetic nanoparticles to treat fluid obstructions
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