JP7598331B2 - Drug solution diffusion system and drug solution diffusion promotion device - Google Patents

Description

The present invention relates to a system for diffusing a medicinal liquid injected into the body in the treatment of cancer and the like, and a medicinal liquid diffusion promotion device.

In the treatment of tumors such as cancer, a method has been proposed in which a medicinal solution is locally administered to a tissue in the body such as a tumor, and then the tissue is irradiated with ultrasound to diffuse the medicinal solution into the tissue. As an apparatus for such treatment, Patent Document 1 discloses a diagnostic and treatment apparatus that includes at least an optical transmitting and receiving means for transmitting and receiving light to a living body, an electroacoustic conversion means for transmitting and receiving ultrasound to a living body, a control means for controlling the direction of transmitting and receiving light and ultrasound, and a drug administration means for administering a drug to the living body to which therapeutic ultrasound is irradiated, the drug administration means having an administration port provided near the tip of a catheter-type applicator. Patent Document 2 discloses an ultrasound catheter system for providing treatment to a treatment site at one or more positions of a subject, the system including a tubular member, a microbubble reservoir, an ultrasound energy source, the ultrasound energy adapted for imaging the treatment site and for bursting the microbubbles, and a control circuit configured to send electrical activation to the ultrasound energy source.

JP 2004-290548 A Special Publication No. 2011-500288

However, the devices described in Patent Documents 1 and 2 leave room for improvement in that the drug solution is difficult to diffuse throughout the tumor. Therefore, the present invention aims to provide a drug solution diffusion system and a drug solution diffusion promotion device that can properly diffuse the drug solution.

One embodiment of the drug solution diffusion system of the present invention that has been able to solve the above problems is a drug solution diffusion system for diffusing a drug solution into a target tissue in a living body, comprising a drug solution injection tube that is inserted into the target tissue, a first ultrasonic wave generating unit that is provided in the drug solution injection tube and generates a first ultrasonic wave for diffusing the drug solution, and an ultrasonic control unit that is connected to the first ultrasonic wave generating unit and controls the irradiation conditions of the first ultrasonic wave according to a two-dimensional or three-dimensional image of the target tissue, and the ultrasonic control unit has a gist that it controls at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave generated by the first ultrasonic wave generating unit. In the drug solution diffusion system, at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave is controlled according to the two-dimensional or three-dimensional image of the target tissue, so that the drug solution can be appropriately diffused to the required area according to the state of the target tissue. This makes it possible to shorten the irradiation time of ultrasonic waves required for treatment, which contributes to reducing the burden on the patient and the surgeon.

It is preferable that the drug solution diffusion system further includes a second ultrasound generating unit that generates a second ultrasound having an oscillation frequency different from that of the first ultrasound, an image forming unit that is connected to the ultrasound control unit and forms an image using a reflected wave when the second ultrasound is irradiated onto the target tissue, and a memory unit that is connected to the ultrasound control unit and stores the image formed by the image forming unit.

The drug solution diffusion system further has a processing unit connected to the ultrasound control unit, which compares an image of the target tissue before drug solution injection with an image of the target tissue after drug solution injection and after irradiation with the first ultrasound, and it is preferable that the ultrasound control unit controls the irradiation conditions of the first ultrasound using the comparison result in the processing unit.

The drug solution diffusion system further has a data storage unit and a processing unit, each connected to the ultrasound control unit, and the data storage unit stores a diffusion pattern table having data on the diffusion pattern of the drug solution according to the type of tumor. The processing unit compares the reference result of the diffusion pattern table with an image of the target tissue after injection of the drug solution and irradiation with the first ultrasound, and it is preferable that the ultrasound control unit controls the irradiation conditions of the first ultrasound using the comparison result in the processing unit.

The drug solution diffusion system further has a measuring unit connected to the ultrasound control unit, which measures at least one of the shape, size, spread and hardness of the tumor from an image taken before drug solution injection, and it is preferable that the ultrasound control unit controls the irradiation conditions of the first ultrasound using the measurement results from the measuring unit.

The drug solution diffusion system further has a processing unit connected to the ultrasound control unit, which compares an image of the target tissue after drug solution injection and before irradiation with the first ultrasound with an image of the target tissue after drug solution injection and after irradiation with the first ultrasound, and it is preferable that the ultrasound control unit controls the irradiation conditions of the first ultrasound using the comparison result in the processing unit.

It is preferable that the drug solution diffusion system further includes a third ultrasound generating unit that generates a third ultrasound having an oscillation frequency different from that of the first ultrasound for heating the target tissue.

In the above drug solution diffusion system, it is preferable that the first ultrasound generating unit generates a first ultrasound, a second ultrasound having an oscillation frequency different from that of the first ultrasound and used for forming a diagnostic image, and a third ultrasound having an oscillation frequency different from that of the first ultrasound for heating the target tissue.

It is preferable that the drug solution diffusion system further includes a liquid supply unit connected to the proximal portion of the drug solution injection tube and supplying the drug solution into the drug solution injection tube, and a cooling unit connected to the liquid supply unit and cooling the drug solution.

The drug solution diffusion system further includes a liquid supply unit connected to the proximal portion of the drug solution injection tube and supplying the drug solution into the drug solution injection tube, and a data storage unit connected to the ultrasound control unit, the data storage unit having a drug solution table containing data on the type of drug solution and a tumor table containing data indicating the condition of tumors previously diagnosed, and the ultrasound control unit preferably selects a type of drug solution from the drug solution table based on the reference result of the tumor table, and issues a command signal to the liquid supply unit to supply the selected type of drug solution into the drug solution injection tube.

In the above-mentioned drug solution diffusion system, it is preferable that the data storage unit further has a frequency table having data on the oscillation frequency of the first ultrasonic wave, and the ultrasonic control unit selects a value of the oscillation frequency of the first ultrasonic wave from the frequency table based on the reference result of the tumor table, and issues a command signal to the first ultrasonic wave generating unit to generate a first ultrasonic wave of the selected oscillation frequency.

In the above-mentioned drug solution diffusion system, it is preferable that the first ultrasonic generating unit includes at least two transducers, and the two transducers are provided on the side wall portion of the drug solution injection tube.

In the above-mentioned drug solution diffusion system, it is preferable that the first ultrasonic generating unit is provided in the inner cavity of the drug solution injection tube and has a rotation axis parallel to the longitudinal axis of the drug solution injection tube.

In the above-mentioned drug solution diffusion system, it is preferable that the first ultrasonic wave generating unit emits the first ultrasonic wave radially outwardly of the drug solution injection tube.

The drug solution diffusion system further has a measuring unit connected to the ultrasound control unit, which measures at least one of the shape, size, spread and hardness of the tumor from an image before drug solution injection, and it is preferable that the ultrasound control unit uses the tumor measurement results from the measuring unit to issue a command signal to the first ultrasound generating unit to change at least one of the intensity and oscillation frequency of the first ultrasound depending on the circumferential position of the drug solution injection tube.

In the above-mentioned drug solution diffusion system, it is preferable that the ultrasound control unit issues a command signal that increases the intensity of the first ultrasound wave in the circumferential direction of the drug solution injection tube, the longer the radial distance from the center of the longitudinal axis of the drug solution injection tube to the outer edge of the tumor.

In the above-mentioned drug solution diffusion system, it is preferable that the ultrasound control unit issues a command signal to lower the oscillation frequency of the first ultrasound wave in the circumferential direction of the drug solution injection tube, the longer the radial distance from the center of the longitudinal axis of the drug solution injection tube to the outer edge of the tumor.

In the above-mentioned drug solution diffusion system, it is preferable that the drug solution contains fine bubbles.

The present invention also provides a drug solution diffusion promotion device. One embodiment of the drug solution diffusion promotion device of the present invention used in the above drug solution diffusion system has a drug solution injection tube that is inserted into the target tissue, and a first ultrasound generating unit that is provided in the drug solution injection tube and generates a first ultrasound wave for diffusing the drug solution, the first ultrasound generating unit including at least two transducers, and the two transducers are provided on the side wall of the drug solution injection tube. This makes it possible to change the direction, position, intensity, etc. of ultrasound irradiation without moving the first ultrasound generating unit.

In the above-mentioned drug solution diffusion promotion device, it is preferable that the first ultrasonic generating unit is provided in the inner cavity of the drug solution injection tube and has a rotation axis parallel to the longitudinal axis of the drug solution injection tube.

According to the above-mentioned drug solution diffusion system, at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave is controlled according to the two-dimensional or three-dimensional image of the target tissue, so that the drug solution can be appropriately diffused to the required area according to the state of the target tissue. This makes it possible to shorten the ultrasonic wave irradiation time required for treatment, which contributes to reducing the burden on the patient and the surgeon. In addition, according to the above-mentioned drug solution diffusion promotion device, the irradiation direction, irradiation position, intensity, etc. of the ultrasonic wave can be changed without moving the first ultrasonic wave generating unit.

1 shows a block diagram of a drug solution diffusion system according to one embodiment of the present invention. FIG. 2 is a cross-sectional side view showing the structure of a liquid drug diffusion promoting device of the liquid drug diffusion system shown in FIG. 1 . 3 is a cross-sectional view of the drug solution diffusion promoting device shown in FIG. 2 taken along line III-III. 3 is a cross-sectional side view showing a modified example of the drug solution diffusion promoting device shown in FIG. 2. FIG. 3 is a cross-sectional side view showing another modified example of the drug solution diffusion promoting device shown in FIG. 2 . 6 is a cross-sectional view taken along line VI-VI of the drug solution diffusion promoting device shown in FIG. 5. 3 shows an image of an ultrasonic diagnostic image when the drug solution injection tube and the ultrasonic generating unit of the drug solution diffusion promoting device shown in FIG. 2 are inserted into a tumor. FIG. 2 is a diagram showing an example of a treatment flow in the chemical solution diffusion system shown in FIG. 1 . FIG. 2 is a diagram showing another example of a treatment flow in the drug solution diffusion system shown in FIG. 1 . FIG. 2 is a diagram showing yet another example of a treatment flow in the drug solution diffusion system shown in FIG. 1 . FIG. 2 is a block diagram of a drug solution diffusion system according to another embodiment of the present invention. FIG. 13 is a block diagram of a drug solution diffusion system according to yet another embodiment of the present invention. FIG. 13 is a diagram showing an example of a treatment flow in the drug solution diffusion system shown in FIG. 12 . FIG. 13 is a block diagram of a drug solution diffusion system according to yet another embodiment of the present invention.

The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to the following embodiments and can of course be modified as appropriate within the scope of the above and below, all of which are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.

One embodiment of the drug solution diffusion system of the present invention is a drug solution diffusion system for diffusing a drug solution to a target tissue in a living body, comprising a drug solution injection tube that is inserted into the target tissue, a first ultrasonic wave generating unit that is provided in the drug solution injection tube and generates a first ultrasonic wave for diffusing the drug solution, and an ultrasonic control unit that is connected to the first ultrasonic wave generating unit and controls the irradiation conditions of the first ultrasonic wave according to a two-dimensional or three-dimensional image of the target tissue, and the ultrasonic control unit has a gist that it controls at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave generated by the first ultrasonic wave generating unit. According to the drug solution diffusion system, at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave is controlled according to the two-dimensional or three-dimensional image of the target tissue, so that the drug solution can be appropriately diffused to a necessary part according to the state of the target tissue. Therefore, it is possible to shorten the irradiation time of the ultrasonic wave required for treatment, which contributes to reducing the burden on the patient and the surgeon.

Drug solution diffusion systems are used to diffuse drug solutions administered locally to target tissues such as tumors in the body in drug therapy, which is one of the methods for treating tumors such as cancer.

The drug solution is administered into the target tissue using a drug solution injection tube, and is diffused into the target tissue by ultrasound emitted from the ultrasound generating unit. The drug solution administered to the target tissue may contain an anticancer drug. Examples of the anticancer drug include cytotoxic anticancer drugs such as metabolic antagonists, microtubule inhibitors, and antitumor antibiotics; endocrine therapy drugs; molecular targeted drugs such as immune checkpoint inhibitors; and viral therapy drugs including tumor-lytic viruses. Alternatively, the drug solution may contain anhydrous ethanol, which is used as an anticancer drug in percutaneous ethanol therapy. The drug solution may contain an ultrasound contrast agent such as perfluorobutane or a galactose-palmitic acid mixture.

It is preferable that the medicinal solution contains fine bubbles. Fine bubbles are air bubbles with a spherical equivalent diameter of 100 μm or less. From a therapeutic perspective, the combined use of fine bubbles and ultrasound can achieve a high drug delivery effect through various mechanisms, such as thermal effects or non-thermal effects such as cavitation or radiation. From a diagnostic perspective, the ultrasound reflection intensity of tissues containing fine bubbles can be increased, making it possible to increase the brightness of ultrasound reflection images.

The diameter of the fine bubbles, the type of gas within the bubbles, and the presence or absence of a shell relative to the gas core can be selected appropriately depending on the condition of the tumor.

The type of gas inside the fine bubbles is not particularly limited, but examples include inert gases such as air, oxygen, nitrogen, carbon dioxide, hydrogen, helium, argon, xenon, and krypton, as well as fluorocarbons and sulfur hexafluoride. These may be used alone or in combination of two or more types.

Examples of materials constituting the shell for the gas core include phospholipids, polycationic lipids, proteins, higher fatty acids, sugars, sterols, surfactants, natural or synthetic molecules, etc. These may be used alone or in combination of two or more.

With reference to Figures 1 to 8, an example of the configuration of a drug solution diffusion system and an example of a treatment flow in this system will be described. Figure 1 shows a block diagram of a drug solution diffusion system according to one embodiment of the present invention. Figure 2 shows a cross-sectional side view showing the structure of a drug solution diffusion promotion device in the drug solution diffusion system shown in Figure 1. Figure 3 shows a cross-sectional view along line III-III of the drug solution diffusion promotion device shown in Figure 2. Figures 4 to 5 show cross-sectional side views showing a modified example of the drug solution diffusion promotion device shown in Figure 2. Figure 6 shows a cross-sectional view along line VI-VI of the drug solution diffusion promotion device shown in Figure 5. Figure 7 shows an image of an ultrasonic diagnostic image when the drug solution injection tube and ultrasonic generator of the drug solution diffusion promotion device shown in Figure 2 are inserted into a tumor. Figure 8 shows a diagram showing an example of a treatment flow in the drug solution diffusion system shown in Figure 1. The drug solution diffusion system 1 has a drug solution injection tube 3, a first ultrasonic wave generator 11, and an ultrasonic control unit 20. FIG. 1 shows an example in which a drug solution diffusion promotion device 2 has a drug solution injection tube 3 that is inserted into a target tissue, and a first ultrasonic wave generating unit 11 that is provided in the drug solution injection tube 3 and generates a first ultrasonic wave for diffusing the drug solution.

The drug solution injection tube 3 has a first end and a second end in the longitudinal direction. The first end can also be called the distal end, and the second end can also be called the proximal end. In the drug solution diffusion system 1 and the drug solution diffusion promotion device 2, the distal side refers to the first end side in the longitudinal direction of the drug solution injection tube 3, which is the side to be treated. The proximal side refers to the second end side in the longitudinal direction of the drug solution injection tube 3, which is the hand side of the user (operator). When each component is divided into two equal parts in the longitudinal direction, the proximal side may be called the proximal part, and the distal side may be called the distal part. In FIG. 2, the left side represents the distal side, and the right side represents the proximal side. The inward side of the drug solution diffusion promotion device 2 refers to the direction toward the center of the longitudinal axis of the drug solution injection tube 3 in the radial direction of the drug solution injection tube 3, and the outward side refers to the radial direction opposite to the inward side.

The drug solution injection tube 3 is a tubular member that is inserted into a target tissue in a living body, and has the function of locally administering a drug solution into the target tissue. The drug solution injection tube 3 has a distal portion and a proximal portion, and the distal portion is provided with a puncture portion 3a that is inserted into the target tissue of the patient. The drug solution injection tube 3 also has one or more internal cavities 3b extending in the longitudinal direction, and at least one internal cavity 3b functions as a flow path through which the drug solution flows.

The distal end of the drug injection tube 3 is provided with an opening 3c that communicates with the outside, and it is preferable that the drug solution can be discharged from the opening 3c to the outside of the drug injection tube 3. The opening 3c may be provided so as to face the distal side as shown in Figure 2, or may be provided in the side wall portion 3d of the drug injection tube 3, although not shown.

As an example of a drug solution injection tube 3 having a puncture portion 3a, as shown in Figure 2, the drug solution injection tube 3 is formed in a needle shape, and the tip of the needle is located on the distal side. There are no particular limitations on the puncture portion 3a as long as it is formed so as to be easily punctured into tissue, but it is preferable that the distal end of the drug solution injection tube 3 has an inclined opening edge 3e as shown in Figure 2.

As shown in Figure 2, a first gripping portion 9 that is held by the surgeon is preferably connected to the proximal portion of the drug injection tube 3.

The drug injection tube 3 may be a hollow coil formed by winding one or more metal wires in a spiral shape, a hollow coil or a hollow body with at least one of the inner and outer surfaces coated with resin, a cylindrical resin tube, or a combination of these connected in the longitudinal direction. When the drug injection tube 3 is a cylindrical resin tube, it may be made of a single layer or multiple layers, and a portion in the longitudinal direction or circumferential direction may be made of a single layer, and the other portion may be made of multiple layers.

The drug injection tube 3 is preferably made of resin or metal. Examples of resins constituting the drug injection tube 3 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine resins, vinyl chloride resins, silicone resins, and natural rubber. These may be used alone or in combination of two or more. Among them, polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine resins are preferably used. Examples of metals constituting the drug injection tube 3 include stainless steel such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, and combinations thereof. In particular, wires made of Ni-Ti alloys have excellent shape memory and high elasticity. The wires may also be fiber materials such as the above-mentioned metals, polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, PBO fibers, and carbon fibers. The fiber materials may be monofilaments or multifilaments. Alternatively, the liquid injection tube 3 may be a cylindrical body made of resin with a reinforcing material such as a metal wire provided therein.

As shown in FIG. 2, the drug solution diffusion promotion device 2 preferably has an outer tube 5 capable of accommodating the drug solution injection tube 3. This allows the drug solution injection tube 3 to be placed in the lumen 5b of the outer tube 5 so as not to damage tissue sites not targeted for treatment or the inside of the forceps channel of the endoscope. The outer tube 5 is a member having a distal portion and a proximal portion. The outer tube 5 also has a first end (distal end) and a second end (proximal end) in the longitudinal axis direction. The outer tube 5 communicates with the outside through an opening 5a provided on the distal side. When the drug solution injection tube 3 is inserted into the target tissue, the puncture portion 3a of the drug solution injection tube 3 is protruded from the opening 5a. The proximal portion of the outer tube 5 may be provided with a second gripping portion 10 for the surgeon to grip. The second gripping portion 10 may be formed, for example, in a cylindrical shape.

For the outer tube 5, please refer to the description of the constituent materials of the chemical injection tube 3. The material of the outer tube 5 may be the same as or different from the material of the chemical injection tube 3. As with the chemical injection tube 3, the outer tube 5 may be a resin tube, a cylindrical body formed by arranging a single wire or multiple wires, or twisted wires in a specific pattern, a metal tube, or a combination of these.

The first ultrasonic generator 11 is provided in the drug injection tube 3 and generates a first ultrasonic wave for diffusing the drug. The first ultrasonic wave is a therapeutic ultrasonic wave for diffusing the drug. The oscillation frequency and ultrasonic output of the first ultrasonic wave generated by the first ultrasonic generator 11 can be set appropriately according to the type of treatment, and the type and dose of the drug. Examples of ultrasonic scanning methods in the first ultrasonic generator 11 include electronic scanning and mechanical scanning. Examples of ultrasonic generation methods include piezoelectric and electrostatic methods.

The oscillation frequency of the first ultrasonic wave is preferably 1 kHz or more, more preferably 10 kHz or more, and even more preferably 100 kHz or more, and is preferably 10 MHz or less, more preferably 1 MHz or less, and even more preferably 500 kHz or less. By setting the oscillation frequency in this way, it is possible to effectively diffuse the medicinal solution.

The ultrasonic output Ispta of the first ultrasonic wave is preferably 100 mW/cm ² or more, more preferably 300 mW/cm ² or more, and even more preferably 500 mW/cm ² or more, and is preferably 10 W/cm ² or less, more preferably 5 W/cm ² or less, and even more preferably 1 W/cm ² or less. By setting the ultrasonic output in this manner, it is possible to effectively diffuse the medicinal solution.

As shown in Figure 2, it is preferable that the first sound wave generating unit 11 emits the first ultrasonic wave radially outward from the drug solution injection tube 3. This makes it possible to irradiate ultrasonic waves toward the target tissue present around the drug solution injection tube 3 when the drug solution injection tube 3 is inserted into the target tissue in the living body. In Figure 2, the propagation direction of the first ultrasonic wave is indicated by direction z. The first ultrasonic wave generating unit 11 may also emit ultrasonic waves toward the distal side of the drug solution injection tube 3.

The first ultrasonic generator 11 may include an ultrasonic probe. The ultrasonic probe converts an electric signal into ultrasonic waves and transmits and receives ultrasonic waves. The ultrasonic probe may be a single transducer type probe, or may be a dual transducer type probe having a transmitting transducer and a receiving transducer. The transducer may have, for example, two electrodes and a piezoelectric material sandwiched between the two electrodes. The piezoelectric material is a crystalline material that exhibits piezoelectricity, and generates a voltage when mechanical strain is applied, or conversely, generates mechanical strain when a voltage is applied. Examples of the piezoelectric material that can be used include barium titanate (BaTiO ₃ ), lead zirconate titanate (PZT), polyvinylidene fluoride (PVDF), and 1-3 composite piezoelectric material.

As shown in Figures 2 and 3, the first ultrasonic generator 11 is preferably provided on the side wall portion 3d of the drug solution injection tube 3. This makes it easier to irradiate ultrasonic waves to the target tissue inside the living body. It is more preferable that the first ultrasonic generator 11 is provided on the puncture portion 3a of the drug solution injection tube 3. This makes it possible to insert the first ultrasonic generator 11 into the target tissue, further enhancing the drug solution diffusion effect.

3, the first ultrasonic generating unit 11 includes at least two transducers 11A, and the two transducers 11A are preferably provided on the side wall 3d of the drug injection tube 3. It is more preferable that the first ultrasonic generating unit 11 includes at least two single-transducer probes, and the transducers 11AB of the at least two single-transducer probes are provided on the side wall 3d of the drug injection tube 3. This makes it possible to use a phased array method in which the direction, position, and intensity of ultrasonic waves can be changed without moving the first ultrasonic generating unit 11 itself by electronically controlling the timing of transmission and reception of each transducer 11A.

The first ultrasonic generating unit 11 includes at least two transducers 11A, which are provided on the side wall 3d of the drug injection tube 3, and it is preferable that the phases of the ultrasonic waves generated by the two transducers 11A are shifted from each other. This makes it possible to change the direction, position, and intensity of the ultrasonic waves without moving the first ultrasonic generating unit 11 itself.

The phases of the ultrasonic waves generated from the two transducers 11A are preferably shifted by T/4 or more, more preferably by T/3 or more, even more preferably by 2T/5 or more, and preferably by 3T/4 or less, more preferably by 2T/3 or less, and even more preferably by T/2 or less. Here, T is the ultrasonic vibration period (unit: s). By setting the phase shift of the ultrasonic waves within the above range in this way, the direction, position, and intensity of the ultrasonic waves can be changed without moving the first ultrasonic generating unit 11.

It is preferable that the two transducers 11A, whose ultrasonic waves are out of phase with each other, are arranged adjacent to each other in the circumferential direction of the drug injection tube 3. By arranging the transducers 11A in this manner, it becomes easier to control the interference of the ultrasonic wave fronts of the two transducers 11A.

The first ultrasonic generating unit 11 includes at least two transducers 11A, which are provided on the side wall 3d of the drug injection tube 3, and it is preferable that the intensities of the ultrasonic waves generated from the two transducers 11A are controlled to be different from each other. By configuring the first ultrasonic generating unit 11 in this way, it is possible to change the direction, position, and intensity of the ultrasonic waves without moving the first ultrasonic generating unit 11 itself.

The transducer 11A can be formed, for example, in a polygonal shape such as a rectangle or a strip, or in a ring shape. By forming the transducer 11A in such a shape, it is possible to arrange a plurality of transducers 11A in an array, i.e., in a regular manner. By forming the transducer 11A in a polygonal shape such as a rectangle or a strip, it becomes easier to arrange a plurality of transducers 11A side by side in the longitudinal or circumferential direction of the drug injection tube 3. In addition, by forming the transducer 11A in a ring shape, ultrasonic waves can be generated over a wide range at once, making it easier to diffuse the drug injected into the target tissue in the circumferential direction. In addition, it becomes easier to arrange a plurality of ring-shaped transducers 11A side by side in the longitudinal direction of the drug injection tube 3.

The number of transducers 11A provided in the first ultrasonic generating unit 11 is not particularly limited, but is preferably 8 or more, more preferably 16 or more, even more preferably 32 or more, and particularly preferably 64 or more, and may be 256 or less, or may be 128 or less. By setting the number of transducers 11A in this way, the direction, position, and intensity of the ultrasonic waves can be precisely controlled.

It is preferable that the first ultrasonic generator 11 includes a plurality of transducers 11A, and the plurality of transducers 11A are arranged continuously. For example, it is preferable that two transducers 11A are arranged adjacent to each other in the circumferential direction of the drug injection tube 3. When the transducers 11A are arranged in this manner, it is possible to construct an image in a 360-degree direction by receiving diagnostic ultrasound in sequence in the circumferential direction. In addition, the intensity and oscillation frequency of the ultrasound can be changed depending on the circumferential position of the drug injection tube 3. In addition, the arrangement of the plurality of transducers 11A is not particularly limited, and they may be arranged side by side in the longitudinal direction of the drug injection tube 3, or they may be arranged side by side in the longitudinal direction and the circumferential direction of the drug injection tube 3.

Figure 4 is a cross-sectional side view showing a modified example of the drug solution diffusion promotion device 2 shown in Figure 2. As shown in Figure 4, it is preferable that a recess 3g is provided in the side wall portion 3d of the drug solution injection tube 3. In this case, it is preferable that at least a part of the first ultrasonic wave generating unit 11 is disposed in the recess 3g. This allows at least a part of the first ultrasonic wave generating unit 11 to be contained in the recess 3g, thereby preventing excessive protrusion of the first ultrasonic wave generating unit 11 radially outward from the drug solution injection tube 3. This makes it easier to puncture the target tissue with the drug solution injection tube 3.

In the radial direction of the drug solution injection tube 3, it is preferable that the outer end of the first ultrasonic generator 11 is located at the same position as the outer end of the drug solution injection tube 3 or is located inward from the outer end of the drug solution injection tube 3. By arranging the first ultrasonic generator 11 in this manner, the first ultrasonic generator 11 does not protrude radially outward from the surface of the drug solution injection tube 3, making it easier to puncture the target tissue of the drug solution injection tube 3. As shown in FIG. 4, an example of such a drug solution diffusion promotion device 2 is one in which the entire first ultrasonic generator 11 is arranged in the recess 3g of the drug solution injection tube 3.

2 and 3 show an example in which the first ultrasonic generating unit 11 is disposed outward from the outer surface of the side wall portion 3d of the drug solution injection tube 3, but as shown in Fig. 4, at least a part of the first ultrasonic generating unit 11 may be disposed within the wall of the side wall portion 3d. In addition, although not shown, at least a part of the first ultrasonic generating unit 11 may be disposed in the inner cavity of the side wall portion 3d.

Let us return to Fig. 3 for further explanation. In the radial direction of the drug injection tube 3, it is preferable that the sound absorbing material 11B is provided inward from the transducer 11A. By providing the sound absorbing material 11B in this way, it is possible to attenuate the ultrasonic waves irradiated inward from the transducer 11A. It is preferable that the transducer 11A is supported by the sound absorbing material 11B. In this way, by supporting the transducer 11A from the back side by the sound absorbing material 11B, it is possible to suppress deformation of the transducer 11A.

The sound-absorbing material 11B may be made of any material that has an appropriate ultrasonic attenuation rate and acoustic impedance, and may be made of, for example, a mixture containing a base material and a filler. Examples of base material materials include resins such as natural rubber, synthetic rubber, epoxy resin, and polyvinyl chloride resin. Examples of filler materials include metal oxides and ceramic particles.

In the radial direction of the drug solution injection tube 3, the transducer 11A is disposed outward from the drug solution injection tube 3, and it is preferable that the specific gravity of the drug solution injection tube 3 is equal to or less than 1. Since the specific gravity of living tissue is approximately 1, the ultrasonic waves irradiated inward from the transducer can be attenuated by imparting a sound absorbing effect to the drug solution injection tube 3 itself in this way.

Although not shown, the first ultrasonic generator 11 may have directionality in the direction of ultrasonic propagation. In that case, since there is no need to provide multiple transducers 11A in the drug solution injection tube 3, it is possible to suppress an increase in the diameter of the drug solution injection tube 3 in the portion where the first ultrasonic generator 11 is provided. As a result, it is possible to reduce the burden on the patient of puncturing the drug solution injection tube 3 into the target tissue.

In the first ultrasound generating unit 11, an acoustic matching layer 11C may be provided radially outward from the transducer 11A. This makes it easier for ultrasound from the first ultrasound generating unit 11 to enter the tumor. From the viewpoint of focusing the ultrasound, it is also preferable that an acoustic lens is provided radially outward from the transducer 11A in the first ultrasound generating unit 11. The acoustic lens may be provided radially outward from the acoustic matching layer 11C.

Although not shown, the transducer 11A and an energy supply source such as a power source can be connected by a conductor. The conductor can be disposed inside the side wall 3d of the drug injection tube 3 or on the outer or inner surface of the side wall 3d. Examples of the conductor include those using conductors of electrical energy or light energy, and the surface may be coated. Examples of the conductor include a conductor having a conductive core coated with a non-conductive material, optical fiber, etc.

Although not shown, a large diameter section having an outer diameter larger than the outer diameter at the center position in the longitudinal direction of the drug injection tube 3 may be provided on the outside of the drug injection tube 3 and proximal to the first ultrasonic generator 11. An example of the large diameter section is a ring-shaped member provided radially outward of the drug injection tube 3. The presence of the large diameter section makes it possible to block the drug injected into the target tissue even if it flows back to the proximal side.

Although not shown, a second drug solution injection tube that is inserted into target tissue in a living body may be further provided in the lumen 3b of the drug solution injection tube 3 in which the first ultrasonic generator 11 is provided on the side wall 3d. This allows drug solution to be discharged not only from the drug solution injection tube 3 but also from the second drug solution injection tube, making it easier for the drug solution to be distributed throughout the tumor, thereby improving the therapeutic effect of the drug solution.

For the configuration of the second liquid medicine injection pipe, the description of the liquid medicine injection pipe 3 can be referred to. The configuration of the second liquid medicine injection pipe may be the same as or different from the configuration of the liquid medicine injection pipe 3. In addition, the type of liquid medicine supplied into the second liquid medicine injection pipe may be the same as or different from the type of liquid medicine supplied into the liquid medicine injection pipe 3.

It is preferable that the second drug solution injection tube is movable in the longitudinal direction of the drug solution injection tube 3 relative to the drug solution injection tube 3. This makes it possible to adjust the release position of the drug solution from the second drug solution injection tube depending on the shape of the target tissue, etc.

When the second drug solution injection tube is moved to the most distal side relative to the drug solution injection tube 3, the distal end of the second drug solution injection tube is preferably located distal to the distal end of the drug solution injection tube 3. This allows the drug solution to be released from the second drug solution injection tube at a position distal to the drug solution injection tube 3, making it easier for the drug solution to reach the distal side of the target tissue and improving the therapeutic effect of the drug solution.

Although not shown, an ultrasonic generator (hereinafter referred to as the "fourth ultrasonic generator") may be provided on the side wall of the second drug injection tube. The fourth ultrasonic generator, like the first ultrasonic generator 11, is a part that generates a fourth ultrasonic wave for diffusing the drug. By providing the fourth ultrasonic generator in this manner, the drug can be more easily distributed throughout the tumor, thereby enhancing the therapeutic effect of the drug.

The oscillation frequency and ultrasonic output of the fourth ultrasonic wave can be set appropriately depending on the type of treatment and the type and dosage of the medicinal solution. The oscillation frequency and ultrasonic output of the fourth ultrasonic wave may be the same as or different from the first ultrasonic wave. For the configuration of the fourth ultrasonic wave generating unit, the description of the first ultrasonic wave generating unit 11 can be referred to.

When the fourth ultrasonic generating unit is provided on the side wall of the second drug injection tube, it is preferable that the distal end of the fourth ultrasonic generating unit is located more distal than the distal end of the first ultrasonic generating unit 11 when the second drug injection tube is moved to the most distal side relative to the drug injection tube 3. This allows the fourth ultrasonic generating unit to generate a fourth ultrasonic wave for diffusing the drug at a position more distal than the drug injection tube 3, making it easier for the drug to spread throughout the tumor and improving the therapeutic effect of the drug.

Figure 5 shows a cross-sectional side view of a modified example of the drug solution diffusion promotion device shown in Figure 2, and Figure 6 shows a cross-sectional view of the drug solution diffusion promotion device shown in Figure 5 taken along line VI-VI. As shown in Figures 5 and 6, the first ultrasonic wave generating unit 11 is provided in the lumen 3b of the drug solution injection tube 3, and may have a rotation axis 11d parallel to the longitudinal axis of the drug solution injection tube 3. In that case, it is preferable that the first ultrasonic wave generating unit 11 rotates 360 degrees around the rotation axis 11d. By providing the first ultrasonic wave generating unit 11 in this manner, a mechanical scanning type drug solution diffusion promotion device 2 can be obtained. Note that a description of the same configuration as the drug solution diffusion promotion device 2 shown in Figures 2 to 4 will be omitted.

When the first ultrasonic generator 11 is provided in the lumen 3b of the drug injection tube 3 and has a rotation axis 11d parallel to the longitudinal axis of the drug injection tube 3, it is preferable that the first ultrasonic generator 11 has directionality in the direction of ultrasonic propagation. This makes it easier to irradiate ultrasonic waves from the first ultrasonic generator 11 to the necessary parts of the target tissue.

In order to prevent the ultrasonic waves generated by the first ultrasonic generator 11 from being absorbed and attenuated by the drug injection tube 3, it is preferable that the specific gravity of the drug injection tube 3 is 1 or more. It is preferable that the specific gravity of at least a portion of the drug injection tube 3 in the longitudinal direction is 1 or more, and for example, it is more preferable that the specific gravity of the portion of the drug injection tube 3 that overlaps with the first ultrasonic generator 11 in the longitudinal direction is 1 or more.

As a configuration in which the first ultrasonic generating unit 11 is disposed in the lumen 3b of the drug solution injection tube 3, there is an embodiment in which the drug solution diffusion promotion device 2 further has an insertion member 4 disposed in the lumen 3b of the drug solution injection tube 3, and the first ultrasonic generating unit 11 is held at the distal end of the insertion member 4. This allows the drug solution to flow in the lumen 3b of the drug solution injection tube 3 and outside the insertion member 4. By rotating the insertion member 4 around a straight line parallel to the longitudinal axis of the drug solution injection tube 3 as the rotation axis 11d, it is possible to rotate the first ultrasonic generating unit 11.

As shown in Figures 5 and 6, the insertion member 4 can be configured to have a hollow shaft 4A extending in the longitudinal direction of the drug injection tube 3, and a support member 4B disposed in the inner cavity of the shaft 4A and extending in the longitudinal direction of the shaft 4A. In this case, the first ultrasonic generator 11 can be fixed to the distal part of the support member 4B. The support member 4B may be fixed to the shaft 4A, or may not be fixed to the shaft 4A. Note that, in order to prevent the drug solution from entering the inner cavity of the shaft 4A, it is preferable that the distal end of the shaft 4A is closed.

For the material constituting the shaft 4A, the description of the material constituting the drug injection tube 3 can be referred to. The material of the shaft 4A may be the same as or different from the material of the drug injection tube 3. As with the drug injection tube 3, the shaft 4A may be a resin tube, a cylindrical body formed by arranging a single wire or multiple wires, or a stranded wire in a specific pattern, a metal tube, or a combination of these. However, in order to prevent the ultrasonic waves generated by the first ultrasonic generating unit 11 from being absorbed and attenuated by the shaft 4A, it is preferable that the specific gravity of the portion of the shaft 4A that overlaps with the first ultrasonic generating unit 11 in the longitudinal direction is 1 or more.

The method of fixing the first ultrasonic generating unit 11 to the distal portion of the support member 4B is not particularly limited, and as shown in FIG. 5, a flat portion 4Ba may be provided on the distal portion of the support member 4B, and the first ultrasonic generating unit 11 may be fixed to the flat portion 4Ba. The first ultrasonic generating unit 11 may be connected to the distal end of the support member 4B. The first ultrasonic generating unit 11 may be provided distal to the support member 4B.

Examples of the support member 4B include a rod-shaped member and a torque wire. Examples of the torque wire include a coil body formed by winding one or more wires in a spiral shape.

In order to change the direction of ultrasonic wave propagation in the drug solution diffusion promotion device 2 shown in Figures 5 and 6, if the support member 4B is not fixed to the shaft 4A, it is necessary to rotate the support member 4B on the proximal side. Therefore, in this case, it is preferable that the support member 4B is a torque wire. This allows the rotational torque on the proximal side to be efficiently transmitted to the first ultrasonic generating unit 11.

Although not shown, when the support member 4B is fixed to the shaft 4A, the shaft 4A may be rotated proximally to change the direction of ultrasonic wave propagation. Therefore, in this case, it is preferable that the wires are arranged in a specific pattern on the shaft 4A. By configuring the shaft 4A in this way, it is also possible to efficiently transmit the rotational torque on the proximal side to the first ultrasonic generating unit 11.

It is preferable that the insertion member 4 is movable in the longitudinal direction of the drug injection tube 3 relative to the drug injection tube 3. This makes it possible to adjust the irradiation position of the first ultrasonic wave from the first ultrasonic generator 11 according to the shape of the target tissue, etc.

When the insertion member 4 is moved to the most distal side relative to the drug injection tube 3, the distal end of the insertion member 4 is preferably located distal to the distal end of the drug injection tube 3. This allows the first ultrasonic wave to be generated at a position distal to the drug injection tube 3, making it easier for the drug to be distributed throughout the tumor, thereby enhancing the therapeutic effect of the drug.

For further details regarding the configuration of the transducer of the first ultrasonic generating unit 11, please refer to the description of the drug solution diffusion promotion device 2 shown in Figures 2 to 4.

Although not shown, an insert member 4 as shown in FIGS. 5 to 6 may be provided in the lumen 3b of the drug injection tube 3 shown in FIGS. 2 to 4. That is, the first ultrasonic generator 11 may be provided on the side wall 3d of the drug injection tube 3, a second insert member may be disposed in the lumen 3b of the drug injection tube 3, and an ultrasonic generator (hereinafter referred to as the "fifth ultrasonic generator") may be held at the distal end of the second insert member. The fifth ultrasonic generator, like the first ultrasonic generator 11, is a part that generates a fifth ultrasonic wave for diffusing the drug solution. By providing the fifth ultrasonic generator in this way, the drug solution can be more easily distributed throughout the entire tumor, thereby enhancing the therapeutic effect of the drug solution.

The oscillation frequency and ultrasonic output of the fifth ultrasonic wave can be set appropriately depending on the type of treatment and the type and dosage of the medicinal solution. The oscillation frequency and ultrasonic output of the fifth ultrasonic wave may be the same as or different from the first ultrasonic wave. For the configuration of the fifth ultrasonic wave generating unit, the explanation of the first ultrasonic wave generating unit 11 can be referred to.

When the fifth ultrasonic generating unit is held at the distal end of the second insertion member, when the second insertion member is moved to the most distal side relative to the drug injection tube 3, it is preferable that the distal end of the second insertion member is located more distal than the distal end of the drug injection tube 3, and it is more preferable that the distal end of the fifth ultrasonic generating unit is located more distal than the distal end of the first ultrasonic generating unit 11. This allows the fifth ultrasonic generating unit to generate a fifth ultrasonic wave for diffusing the drug solution at a position more distal than the drug injection tube 3, making it easier for the drug solution to spread throughout the tumor, thereby improving the therapeutic effect of the drug solution.

The ultrasound control unit 20 is connected to the first ultrasound generating unit 11 and controls the irradiation conditions of the first ultrasound according to the two-dimensional or three-dimensional image of the target tissue. In detail, it controls at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasound generated by the first ultrasound generating unit 11. According to the drug solution diffusion system 1, at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasound is controlled according to the two-dimensional or three-dimensional image of the target tissue, so that the drug solution can be appropriately diffused to the required site according to the state of the target tissue. For example, when the tumor has an irregular shape, when the hardness of the tumor is nonuniform, when the radial distance from the center of the longitudinal axis of the drug solution injection tube 3 to the outer edge of the tumor when the drug solution injection tube 3 is punctured into the tumor, depending on the circumferential position of the drug solution injection tube 3, etc., the irradiation conditions of the first ultrasound can be appropriately set according to the state of the tumor, such as the shape, size, spread, and hardness. This makes it easier for the drug solution to spread throughout the entire tumor, thereby improving the therapeutic effect of the drug solution. In addition, it is possible to shorten the ultrasonic irradiation time required for treatment, which contributes to reducing the burden on patients and surgeons.

It is preferable that the ultrasound control unit 20 issues a command signal to the first ultrasound generating unit 11 to vary over time at least one of the propagation direction, intensity, and oscillation frequency of the ultrasound generated by the first ultrasound generating unit 11. By varying the ultrasound conditions over time in this manner, the effect of promoting the diffusion of the drug solution can be enhanced. A two-dimensional or three-dimensional image of the target tissue can be obtained using an image forming unit 23 preferably included in the drug solution diffusion system 1, or an external device not included in the system 1. The ultrasound control unit 20 controls the irradiation conditions of the first ultrasound according to the obtained two-dimensional or three-dimensional image of the target tissue.

The ultrasound control unit 20 may issue a command signal to the first ultrasound generating unit 11 to change at least one of the intensity and the oscillation frequency of the first ultrasound depending on the longitudinal or circumferential position of the drug injection tube 3. This makes it possible to set the irradiation conditions of the first ultrasound depending on the state of the tumor and the degree of penetration of the drug into the tumor before irradiation with the first ultrasound, thereby making it possible to enhance the diffusion effect of the drug.

It is preferable that the ultrasound control unit 20 issues a command signal to the first ultrasound generating unit 11 to shift the intensity distribution of the ultrasound from the longitudinal axis center 3f of the drug injection tube 3. By shifting the intensity distribution of the ultrasound in this way, the drug solution can be appropriately diffused to the required area. FIG. 7 is an image diagram of an ultrasound diagnostic image when the drug injection tube 3 and the first ultrasound generating unit 11 shown in FIG. 2 are inserted into the tumor 100. As shown in FIG. 7, the ultrasound control unit 20 may issue a command signal to increase the intensity x of the first ultrasound as the radial distance from the longitudinal axis center 3f of the drug injection tube 3 to the outer edge 101 of the tumor 100 becomes longer in the circumferential direction of the drug injection tube 3. This makes it easier for the drug solution to spread throughout the entire tumor, thereby improving the therapeutic effect of the drug solution.

The intensity distribution of the first ultrasonic wave being offset from the longitudinal axis center 3f of the drug injection tube 3 means that the ultrasonic wave intensity x varies depending on the circumferential position of the drug injection tube 3. In FIG. 7, the ultrasonic wave intensity x increases as the radial distance from the axial center 3f of the drug injection tube 3 to the outer edge 101 of the tumor 100 increases, but the circumferential intensity of the ultrasonic wave can be set appropriately depending on the shape, size, spread, hardness, and other conditions of the tumor.

The ultrasound control unit 20 may issue a command signal to lower the oscillation frequency of the first ultrasound as the radial distance from the longitudinal axis center 3f of the drug injection tube 3 to the outer edge 101 of the tumor 100 increases in the circumferential direction of the drug injection tube 3. Setting the irradiation conditions of the first ultrasound in this manner also makes it easier for the drug to spread throughout the entire tumor, thereby improving the therapeutic effect of the drug.

In the drug solution diffusion system 1, a program for carrying out each process by at least one of the ultrasound control unit 20 and the processing unit 30 described below may be recorded on a computer-readable medium. This allows the program to be installed on a computer. The computer-readable medium on which the program is recorded may be a non-transient recording medium. Examples of non-transient recording media include recording media such as CD-ROMs.

The drug solution diffusion system 1 may include a processor for executing the above program in at least one of the ultrasonic control unit 20 and the processing unit 30 described below. The processor includes a microprocessor implemented in an integrated circuit. The computer may include the processor and the storage device described below.

The control in the ultrasonic control unit 20 may be performed using on-off control, variable PI control, or of course PID control.

Figure 8 shows an example of a treatment flow in the drug solution diffusion system 1 shown in Figure 1. Using the drug solution diffusion system 1 in Figure 1, the following treatment steps can be performed.

The drug injection tube 3 is inserted into the target tissue (step S1). In step S1, it is preferable that the first ultrasonic generator 11 is placed in the target tissue. Then, the drug is injected into the target tissue (step S2). The ultrasonic control unit 20 controls the irradiation conditions of the first ultrasonic wave according to the two-dimensional or three-dimensional image of the target tissue (step S3). In step S3, at least one of the propagation direction, intensity, and oscillation frequency of the first ultrasonic wave generated by the first ultrasonic generator 11 is controlled. The first ultrasonic wave is irradiated to the target tissue using the first ultrasonic generator 11 according to the irradiation conditions set in step S3 (step S4). Although not required, after the irradiation of the first ultrasonic wave in step S4, a two-dimensional or three-dimensional image of the target tissue may be obtained (step S5). It is preferable to check the diffusion state of the drug using the image obtained in step S5 (step S6). If it is determined in step S6 that the diffusion state of the drug solution has not reached the target value, it is preferable to return to step S3, control the irradiation conditions of the first ultrasonic wave, and perform steps S4 and subsequent steps. If it is determined in step S6 that the diffusion state of the drug solution has reached the target value, the treatment is terminated.

As shown in Fig. 1, the drug solution diffusion system 1 may further include a second ultrasound generating unit 12 that generates a second ultrasound having an oscillation frequency different from that of the first ultrasound. A two-dimensional or three-dimensional image of the target tissue can be formed using the reflected waves when the second ultrasound is irradiated onto the target tissue. In other words, the second ultrasound can be used to generate a diagnostic image.

The image formed using the reflected waves when the second ultrasound is irradiated to the target tissue may be a two-dimensional image or a three-dimensional image. The image formed using the reflected waves may be a still image or a video image.

The oscillation frequency and ultrasonic output of the second ultrasonic wave generated by the second ultrasonic generating unit 12 can be set appropriately depending on the type of treatment and the type and dosage of the medicinal solution.

The oscillation frequency of the second ultrasonic wave may be higher than the oscillation frequency of the first ultrasonic wave. For example, the oscillation frequency of the second ultrasonic wave is preferably 20 MHz or more, more preferably 30 MHz or more, and even more preferably 40 MHz or more, and is preferably 100 MHz or less, more preferably 90 MHz or less, and even more preferably 80 MHz or less. Setting the oscillation frequency in this manner makes it easier to generate diagnostic images.

The ultrasonic output Ispta of the second ultrasonic wave is preferably 30 mW/cm ² or more, more preferably 50 mW/cm ² or more, and even more preferably 100 mW/cm ² or more, and is preferably 720 W/cm ² or less, more preferably 500 W/cm ² or less, and even more preferably 300 W/cm ² or less. Setting the ultrasonic output in this manner makes it easier to generate diagnostic images.

The second ultrasonic generating unit 12 may be provided in the drug solution injection tube 3 as shown in Figures 1 and 2, but may also be provided in the outer tube 5, or may be provided separately from the drug solution diffusion promotion device 2. The first ultrasonic generating unit 11 may also serve as the second ultrasonic generating unit 12. In other words, the first ultrasonic generating unit 11 may generate the first ultrasonic wave and the second ultrasonic wave.

For further details regarding the configuration of the second ultrasonic generating unit 12, the description of the first ultrasonic generating unit 11 can be referred to.

It is preferable that the ultrasound control unit 20 controls the type or amount of the medicinal liquid supplied to the medicinal liquid injection tube 3 according to a two-dimensional or three-dimensional image formed using the reflected waves when the second ultrasound is irradiated onto the target tissue. This allows the medicinal liquid to be administered appropriately to the target tissue.

As shown in FIG. 1, the drug solution diffusion system 1 preferably further includes an image forming unit 23 connected to the ultrasound control unit 20 and forming an image using reflected waves when the target tissue is irradiated with the second ultrasound, and a memory unit 25 connected to the ultrasound control unit 20 and storing the image formed by the image forming unit 23. The image formed using the reflected waves when the target tissue is irradiated with the second ultrasound makes it possible to visualize the state of the target tissue before drug solution injection, after drug solution injection, after irradiation, etc., and can be used for diagnosis. In addition, by storing diagnostic images in the memory unit 25, data can be read out as appropriate when processing data in the processing unit described later, which can be useful for verifying the validity of the treatment and formulating further treatment plans.

The image forming unit 23 forms a two-dimensional or three-dimensional image of the target tissue using the reflected waves when the second ultrasonic wave is irradiated to the target tissue. The image forming unit 23 is preferably connected to the memory unit 25. This allows the image formed by the image forming unit 23 to be transmitted to the memory unit 25, making it possible to read the image from the memory unit 25 when setting the irradiation conditions. Note that a processor preferably provided in the drug solution diffusion system 1 may execute the program of the image forming unit 23. Although not shown, the image forming unit 23 may be connected to the processing unit 30 described later. This allows the processing unit 30 to perform processing necessary for understanding the state of the target tissue, such as comparing images, using the images formed by the image forming unit 23.

The memory unit 25 may be a main memory device such as a RAM or ROM included in the computer, or an auxiliary memory device such as a hard disk.

Although not shown, the drug solution diffusion system 1 may further include a receiving unit that receives the reflected waves when the target tissue is irradiated with the second ultrasonic wave, and a display unit that is connected to the receiving unit and displays an image formed using the reflected waves when the target tissue is irradiated with the second ultrasonic wave. In this case, it is preferable that the image forming unit 23 is connected to the receiving unit. This allows the reflected waves when the target tissue is irradiated with the second ultrasonic wave to be transmitted to the image forming unit 23 via the receiving unit.

As shown in Figure 1, it is preferable that the drug solution diffusion system 1 further includes a processing unit 30 connected to the ultrasound control unit 20. This allows the processing unit 30 to perform various processes such as calculations and comparisons to grasp the state of the target tissue.

The processing unit 30 compares an image of the target tissue before the drug injection with an image of the target tissue after the drug injection, and it is preferable that the ultrasound control unit 20 controls the irradiation conditions of the first ultrasound using the comparison results from the processing unit 30. This makes it possible to set appropriate irradiation conditions based on the comparison results of the state of the target tissue before and after the drug injection.

The processing unit 30 compares an image of the target tissue before the drug injection with an image of the target tissue after the drug injection and after the irradiation of the first ultrasound, and the ultrasound control unit 20 preferably controls the irradiation conditions of the first ultrasound using the comparison result in the processing unit 30. This makes it possible to determine whether or not additional irradiation of the first ultrasound is necessary based on the comparison result of the state of the target tissue before the drug injection and after the drug injection and after the irradiation of the first ultrasound.

The processing unit 30 compares an image of the target tissue after the drug injection and before the irradiation of the first ultrasound with an image of the target tissue after the drug injection and after the irradiation of the first ultrasound, and the ultrasound control unit 20 preferably controls the irradiation conditions of the first ultrasound using the comparison result in the processing unit 30. This makes it possible to determine whether or not additional irradiation of the first ultrasound is necessary based on the comparison result of the state of the target tissue before and after the irradiation of the first ultrasound after the drug injection.

The processing unit 30 compares an image of the target tissue after the injection of the drug solution and the nth first ultrasonic wave irradiation with an image of the target tissue after the injection of the drug solution and the n+1th first ultrasonic wave irradiation, and it is preferable that the ultrasound control unit 20 controls the irradiation conditions of the n+2th first ultrasonic wave using the comparison result in the processing unit 30. Note that n is an integer equal to or greater than 1. This makes it possible to appropriately set the irradiation conditions of the n+2th first ultrasonic wave in accordance with the state of the target tissue.

Figure 9 shows another example of a treatment flow in the drug solution diffusion system 1 shown in Figure 1. The drug solution diffusion system 1 of Figure 1 may be used to perform the following procedure. Note that the flow shown in Figure 9 differs from the flow shown in Figure 8 in that a second ultrasonic wave is generated by the second ultrasonic wave generator 12, a two-dimensional or three-dimensional image is formed using the reflected waves when the second ultrasonic wave is irradiated to the target tissue, and the formed image is used to control the irradiation conditions of the first ultrasonic wave and to determine the diffusion state of the drug solution.

The drug injection tube 3 is inserted into the target tissue (step S11). In step S11, it is preferable that the first ultrasonic generator 11 and the second ultrasonic generator 12 are placed in the target tissue. Next, the second ultrasonic generator 12 generates a second ultrasonic wave, and a two-dimensional or three-dimensional image is formed using the reflected wave when the second ultrasonic wave is irradiated onto the target tissue (step S12). This makes it possible to visualize the state of the target tissue before drug injection. The drug is injected into the target tissue (step S13). If necessary, the second ultrasonic generator 12 generates a second ultrasonic wave, and a two-dimensional or three-dimensional image of the target tissue after drug injection may be formed using the reflected wave when the second ultrasonic wave is irradiated onto the target tissue (step S14). It is preferable that the ultrasound control unit 20 controls the irradiation conditions of the first ultrasonic wave according to the two-dimensional or three-dimensional image of the target tissue at least either before or after drug injection (step S15). According to the irradiation conditions set in step S15, the first ultrasonic wave is irradiated to the target tissue using the first ultrasonic wave generator 11 (step S16). The second ultrasonic wave is generated by the second ultrasonic wave generator 12, and a two-dimensional or three-dimensional image of the target tissue after the injection of the drug solution and after the irradiation of the first ultrasonic wave is formed using the reflected wave when the second ultrasonic wave is irradiated to the target tissue (step S17). It is preferable to confirm the diffusion state of the drug solution using the image formed in step S17 (step S18). If it is determined in step S18 that the diffusion state of the drug solution has not reached the target value, it is preferable to return to step S15, control the irradiation conditions of the first ultrasonic wave, and perform steps S16 and after. If it is determined in step S18 that the diffusion state of the drug solution has reached the target value, the treatment is terminated.

Figure 10 shows another example of a treatment flow in the drug solution diffusion system 1 shown in Figure 1. The drug solution diffusion system 1 of Figure 1 may be used to perform the following treatment steps.

Steps S21 to S27 shown in FIG. 10 are the same as steps S11 to S17 shown in FIG. 9, so the description will be omitted. As shown in FIG. 10, after step S27, the processing unit 30 compares the two-dimensional or three-dimensional image of the target tissue before the drug injection formed in step S22 with the two-dimensional or three-dimensional image of the target tissue after the drug injection and after the irradiation of the first ultrasonic wave formed in step S27 (step S28). In step S28, if it is determined based on the image comparison result that the diffusion state of the drug solution has not reached the target value, it is preferable to return to step S25, control the irradiation conditions of the first ultrasonic wave, and perform steps S26 and after. In step S28, if it is determined based on the image comparison result that the diffusion state of the drug solution has reached the target value, the treatment is terminated.

Figure 11 is a block diagram showing a modified example of the drug solution diffusion system 1 shown in Figure 1. As shown in Figure 11, the second ultrasonic wave generating unit 12 may be provided outside the drug solution injection tube 3. That is, the drug solution diffusion system 1 may have a diagnostic ultrasonic generator having the second ultrasonic wave generating unit 12 in addition to the drug solution diffusion promotion device 2. The drug solution diffusion system 1 in Figure 11 can also perform treatment in the same manner as the drug solution diffusion system 1 in Figure 1. Although not shown in Figure 11, the drug solution diffusion system 1 may have an image forming unit 23. The same applies to the aspects shown below.

With reference to FIG. 12, a drug solution diffusion system 1 having a different configuration from those in FIG. 1 and FIG. 11 will be described. FIG. 12 is a block diagram showing another modified example of the drug solution diffusion system 1 shown in FIG. 1. As shown in FIG. 12, the drug solution diffusion system 1 may have a drug solution injection tube 3, an ultrasonic control unit 20, a processing unit 30, and a data storage unit 35 connected to the ultrasonic control unit 20. The data storage unit 35 can store reference data necessary for setting the irradiation conditions of the first ultrasonic wave. The data storage unit 35 may be a main storage device such as a RAM or ROM included in a computer or an auxiliary storage device such as a hard disk, similar to the storage unit 25. That is, the storage unit 25 and the data storage unit 35 can be provided in the main storage device or the auxiliary storage device.

It is preferable that the data storage unit 35 stores a diffusion pattern table having data on the diffusion pattern of the drug solution according to the type of tumor. In this case, it is preferable that the processing unit 30 compares the reference result of the diffusion pattern table with the image of the target tissue after the drug solution is injected and after the first ultrasound is applied, and the ultrasound control unit 20 controls the irradiation conditions of the first ultrasound using the comparison result of the processing unit 30. This makes it possible to determine whether or not an additional first ultrasound is required to be applied based on the comparison result of the reference result of the diffusion pattern table with the state of the target tissue after the drug solution is injected and after the first ultrasound is applied.

Tumor type data stored in the diffusion pattern table includes the location where the tumor is formed, its shape, size, spread, hardness, etc.

The data on the diffusion pattern of the medicinal solution stored in the diffusion pattern table includes two-dimensional or three-dimensional images formed using reflected waves when diagnostic ultrasound was irradiated onto the target tissue before the medicinal solution was injected into the tumor in past cases.

As shown in Fig. 12, the drug solution diffusion system 1 may have a memory unit 25 and a data storage unit 35. This makes it possible to perform a process of comparing the image stored in the memory unit 25 with the data stored in the data storage unit 35.

12, the drug solution diffusion system 1 may further include a liquid supply unit 40 connected to the proximal portion of the drug solution injection tube 3 and supplying the drug solution into the drug solution injection tube 3, and a data storage unit 35 connected to the ultrasound control unit 20. In this case, the data storage unit 35 preferably includes a drug solution table having data on the type of drug solution and a tumor table having data showing the state of a tumor previously diagnosed, and the ultrasound control unit 20 preferably selects the type of drug solution from the drug solution table based on the reference result of the tumor table, and issues a command signal to the liquid supply unit 40 to supply the selected type of drug solution into the drug solution injection tube 3. This allows the type of drug solution appropriate for the type of tumor to be selected, thereby further enhancing the drug solution diffusion effect.

The liquid supply unit 40 is a member for supplying the medicinal liquid to the lumen 3b of the medicinal liquid injection tube 3, and may be, for example, a syringe or an injection pump controlled by a motor.

12, when the drug solution diffusion system 1 has a data storage unit 35, the data storage unit 35 preferably further has a frequency table including data on the oscillation frequency of the first ultrasonic wave. In that case, the ultrasound control unit 20 preferably selects the value of the oscillation frequency of the first ultrasonic wave from the frequency table based on the reference result of the tumor table, and issues a command signal to the first ultrasonic wave generating unit 11 to generate a first ultrasonic wave of the selected oscillation frequency. This makes it possible to select an appropriate oscillation frequency of the first ultrasonic wave that is suitable for the type of tumor, thereby further enhancing the drug solution diffusion effect in the target tissue.

Figure 13 shows an example of a treatment flow in the drug solution diffusion system 1 shown in Figure 12. Using the drug solution diffusion system 1 in Figure 12, the following treatment steps can be performed.

Steps S31 to S37 shown in FIG. 13 are the same as steps S11 to S17 shown in FIG. 9, so their explanations are omitted. The flow shown in FIG. 13 is different from the flow shown in FIG. 9 in that the processing unit 30 compares the reference result of the diffusion pattern table containing data on the diffusion pattern of the drug solution according to the type of tumor stored in the data storage unit 35 with the image formed in step S37 after drug solution injection and after the first ultrasonic wave irradiation (step S38). If it is determined based on the comparison result in step S38 that the diffusion state of the drug solution has not reached the target value, it is preferable to return to step S35, control the irradiation conditions of the first ultrasonic wave, and perform steps S36 and after. If it is determined based on the comparison result in step S38 that the diffusion state of the drug solution has reached the target value, the treatment is terminated.

With reference to FIG. 14, a drug solution diffusion system 1 having a different configuration from those in FIG. 1 and FIG. 11 will be described. FIG. 14 is a block diagram showing yet another modified example of the drug solution diffusion system 1 shown in FIG. 1. As shown in FIG. 14, the drug solution diffusion system 1 may further have a measurement unit 45 connected to the ultrasound control unit 20. In that case, the measurement unit 45 measures at least one of the shape, size, spread, and hardness of the tumor from the image before drug solution injection, and it is preferable that the ultrasound control unit 20 controls the irradiation conditions of the first ultrasound using the measurement results in the measurement unit 45. This allows the irradiation conditions of the first ultrasound to be set appropriately according to the state of the tumor, thereby enhancing the drug solution diffusion effect in the target tissue.

The measuring unit 45 is preferably a part that analyzes the shape, size, spread, and hardness of the tumor before the first ultrasound is applied using a two-dimensional or three-dimensional image of the target tissue before the drug solution is injected. In this case, a processor preferably provided in the drug solution diffusion system 1 may execute the program of the measuring unit 45.

The measuring unit 45 may be a device that directly measures various parameters such as the shape and size of the tumor. For example, an ultrasonic hardness meter may be mentioned as a device that directly measures the hardness of a tumor. The first ultrasonic generator 11 can be configured to also function as the measuring unit 45 by generating ultrasonic waves of a frequency range suitable for measuring hardness that is different from the first ultrasonic waves.

When the drug solution diffusion system 1 further includes a measuring unit 45 connected to the ultrasound control unit 20, the measuring unit 45 measures at least one of the shape, size, spread, and hardness of the tumor from the image before drug solution injection, and the ultrasound control unit 20 preferably uses the tumor measurement results from the measuring unit 45 to issue a command signal to the first ultrasound generating unit 11 to change at least one of the intensity and oscillation frequency of the first ultrasound depending on the circumferential position of the drug solution injection tube 3. This allows the irradiation conditions of the first ultrasound to be set appropriately according to the state of the tumor, thereby further enhancing the drug solution diffusion effect in the target tissue.

In the circumferential direction of the drug injection tube 3, the harder the tumor is, the greater the intensity of the ultrasound generated by the first ultrasound generating unit 11 may be. This makes it easier for the drug to reach the hard parts of the tumor, thereby improving the therapeutic effect of the drug.

14, it is preferable that the drug solution diffusion system 1 further includes a third ultrasound generating unit 13 that generates a third ultrasound having an oscillation frequency different from that of the first ultrasound for heating the target tissue. The manifestation of the hyperthermia effect can further enhance the drug solution diffusion effect and the immune enhancing effect in the target tissue.

The oscillation frequency and ultrasonic output of the third ultrasonic wave can be set appropriately according to the type of treatment and the type and dosage of the medicinal liquid. For example, the oscillation frequency of the third ultrasonic wave may be lower than the oscillation frequency of the second ultrasonic wave, and may be set to, for example, 10 kHz or more, 100 kHz or more, or 1 MHz or more, or 100 MHz or less, 10 MHz or less, or 5 MHz or less. By setting the oscillation frequency in this way, a hyperthermia effect can be achieved.

For further details regarding the configuration of the third ultrasonic generating unit 13, the description of the first ultrasonic generating unit 11 can be referred to.

The first ultrasonic generating unit 11 may also function as a second ultrasonic generating unit 12 that generates a second ultrasonic wave having a different oscillation frequency from the first ultrasonic wave, and as a third ultrasonic generating unit 13. That is, the first ultrasonic generating unit 11 may generate a first ultrasonic wave, a second ultrasonic wave having a different oscillation frequency from the first ultrasonic wave and used for forming a diagnostic image, and a third ultrasonic wave having a different oscillation frequency from the first ultrasonic wave and for heating the target tissue. This eliminates the need to provide separate ultrasonic generating units for generating the first ultrasonic wave (therapeutic ultrasonic wave), the second ultrasonic wave (diagnostic ultrasonic wave), and the third ultrasonic wave (hyperthermia ultrasonic wave).

14, the drug solution diffusion system 1 preferably has a liquid supply unit 40 that is connected to the proximal portion of the drug solution injection tube 3 and supplies the drug solution into the drug solution injection tube 3, and a cooling unit 50 that is connected to the liquid supply unit 40 and cools the drug solution. This makes it possible to supply the drug solution, the temperature of which has been adjusted by the cooling unit 50, into the drug solution injection tube 3, thereby preventing excessive heating of the drug solution.

The cooling unit 50 may directly cool the liquid medicine, but it is preferable to cool the container in which the liquid medicine is stored. The cooling unit 50 may be a cooler that forms fins around the container and uses a blower to cool the container, a heat pump type cooler, a Peltier element cooler, or the like.

This application claims the benefit of priority based on Japanese Patent Application No. 2019-207836 and Japanese Patent Application No. 2019-207837, filed on November 18, 2019. The entire contents of the specifications of Japanese Patent Application No. 2019-207836 and Japanese Patent Application No. 2019-207837, filed on November 18, 2019, are incorporated by reference into this application.

1: Drug solution diffusion system 2: Drug solution diffusion promotion device 3: Drug solution injection tube 3a: Puncture section, 3b: Inner cavity, 3c: Opening, 3d: Side wall section, 3e: Opening edge, 3f: Longitudinal axis center, 3g: Recess 4: Insertion member 4A: Shaft, 4B: Support member 5: Outer tube 9: First gripping section 10: Second gripping section 11: First ultrasonic generating section 11A: Transducer, 11AB: Transducer of single transducer type probe, 11B: Sound absorbing material, 11C: Acoustic matching layer, 11d: Rotation axis 12: Second ultrasonic generating section 13: Third ultrasonic generating section 20: Ultrasound control section 23: Image forming section 25: Memory section 30: Processing section 35: Data storage section 40: Liquid supply section 45: Measurement section 50: Cooling section 100: Tumor 101: Outer edge x: Intensity of first ultrasonic wave

Claims (20)

A drug solution diffusion system for diffusing a drug solution into a target tissue in a living body, comprising:
a drug solution injection tube that is inserted into the target tissue and has a side wall and an inner cavity through which the drug solution flows ;
a first ultrasonic generating unit provided on the side wall of the drug injection tube and configured to generate a first ultrasonic wave for diffusing the drug;
an ultrasound control unit connected to the first ultrasound generating unit and controlling irradiation conditions of the first ultrasound waves in accordance with a two-dimensional or three-dimensional image of a target tissue;
The ultrasonic control unit controls at least one of a propagation direction, an intensity, and an oscillation frequency of the first ultrasonic wave generated by the first ultrasonic wave generating unit,
the side wall portion has an inner surface facing the lumen and an outer surface facing the outside of the drug solution injection tube,
A recess is provided on an outer surface of the side wall portion,
The first ultrasonic generating unit is disposed in the recess,
In a radial direction of the liquid injection tube, an outer end of the first ultrasonic generating unit is located at the same position as an outer end of the liquid injection tube or is located inward of the outer end of the liquid injection tube ,
A drug solution diffusion system , wherein an inner end of the first ultrasonic generating portion is located outwardly of an inner surface of the side wall portion in a radial direction of the drug solution injection pipe . a second ultrasonic generating unit that generates a second ultrasonic wave having an oscillation frequency different from that of the first ultrasonic wave;
an image forming unit connected to the ultrasound control unit and forming the image using a reflected wave when the second ultrasound is irradiated onto a target tissue;
2. The drug solution diffusion system according to claim 1, further comprising: a storage unit connected to said ultrasound control unit, said storage unit storing said image formed by said image forming unit. A processor connected to the ultrasonic controller,
The processing unit compares the image of the target tissue before the drug solution is injected with the image of the target tissue after the drug solution is injected and after the first ultrasonic wave is irradiated,
3. The drug solution diffusion system according to claim 1, wherein the ultrasonic control unit controls irradiation conditions of the first ultrasonic wave by using a comparison result in the processing unit. a data storage unit and a processing unit, each connected to the ultrasound control unit;
the data storage unit stores a diffusion pattern table including data on diffusion patterns of medicinal liquids according to types of tumors;
The processing unit compares a reference result of the diffusion pattern table with the image of the target tissue after the drug solution is injected and after the first ultrasonic wave is irradiated,
3. The drug solution diffusion system according to claim 1, wherein the ultrasonic control unit controls irradiation conditions of the first ultrasonic wave by using a comparison result in the processing unit. A measuring unit connected to the ultrasonic control unit,
The measurement unit measures at least one of a shape, a size, a spread, and a hardness of a tumor from the image before the drug solution is injected,
5. The drug solution diffusion system according to claim 1, wherein the ultrasonic control unit controls an irradiation condition of the first ultrasonic wave by using a measurement result from the measurement unit. A processor connected to the ultrasonic controller,
The processing unit compares the image of the target tissue after the injection of the drug solution and before the irradiation of the first ultrasonic wave with the image of the target tissue after the injection of the drug solution and after the irradiation of the first ultrasonic wave,
6. The drug solution diffusion system according to claim 1, wherein the ultrasonic control unit controls an irradiation condition of the first ultrasonic wave by using a comparison result in the processing unit. The drug solution diffusion system according to any one of claims 1 to 6, further comprising a third ultrasound generating unit that generates a third ultrasound having an oscillation frequency different from that of the first ultrasound for heating the target tissue. The drug solution diffusion system according to any one of claims 1 to 6, wherein the first ultrasonic wave generating unit generates a second ultrasonic wave having an oscillation frequency different from that of the first ultrasonic wave and used for forming a diagnostic image, and a third ultrasonic wave having an oscillation frequency different from that of the first ultrasonic wave and used for heating target tissue. A liquid supply unit connected to a proximal portion of the drug solution injection tube and supplying the drug solution into the drug solution injection tube;
9. The drug solution diffusion system according to claim 1, further comprising: a cooling section connected to the liquid supply section and configured to cool the drug solution. A liquid supply unit connected to a proximal portion of the drug solution injection tube and supplying the drug solution into the drug solution injection tube;
A data storage unit connected to the ultrasound control unit,
The data storage unit includes a liquid medicine table including data on types of liquid medicine, and a tumor table including data on the states of tumors previously diagnosed,
The drug solution diffusion system according to any one of claims 1 to 9, wherein the ultrasound control unit selects a type of drug solution from the drug solution table based on the reference result of the tumor table, and issues a command signal to the liquid supply unit to supply the selected type of drug solution into the drug solution injection tube. The data storage unit further includes a frequency table including data on an oscillation frequency of the first ultrasonic wave,
The drug solution diffusion system according to claim 10, wherein the ultrasound control unit selects a value of an oscillation frequency of the first ultrasound from the frequency table based on a reference result of the tumor table, and issues a command signal to the first ultrasound generating unit to generate the first ultrasound of the selected oscillation frequency. The drug solution diffusion system according to any one of claims 1 to 11, wherein the first ultrasonic generating unit includes at least two transducers, and the two transducers are provided on the side wall of the drug solution injection tube. The drug solution diffusion system according to any one of claims 1 to 12, wherein the first ultrasonic wave generating unit emits the first ultrasonic wave radially outward from the drug solution injection tube. A measuring unit connected to the ultrasonic control unit,
The measurement unit measures at least one of a shape, a size, a spread, and a hardness of a tumor from the image before the drug solution is injected,
14. The drug solution diffusion system according to claim 12 or 13, wherein the ultrasound control unit uses the measurement results of the tumor by the measurement unit to issue a command signal to the first ultrasound generating unit to change at least one of the intensity and oscillation frequency of the first ultrasound depending on the circumferential position of the drug solution injection tube. The drug solution diffusion system according to claim 14, wherein the ultrasound control unit issues a command signal that increases the intensity of the first ultrasound as the radial distance from the center of the longitudinal axis of the drug solution injection tube to the outer edge of the tumor increases in the circumferential direction of the drug solution injection tube. The drug solution diffusion system according to claim 14 or 15, wherein the ultrasound control unit issues a command signal to lower the oscillation frequency of the first ultrasound as the radial distance from the center of the longitudinal axis of the drug solution injection tube to the outer edge of the tumor increases in the circumferential direction of the drug solution injection tube. The drug solution diffusion system according to any one of claims 1 to 16, wherein the drug solution contains fine bubbles. All of the ultrasonic generating units are provided on the side wall of the drug solution injection tube ,
The drug solution diffusion system according to any one of claims 1 to 17 , wherein none of the ultrasonic wave generating units is provided in the inner cavity through which the drug solution flows . The drug solution diffusion system according to any one of claims 1 to 18, wherein the drug solution injection tube has a puncture part that is inserted into the target tissue, and the first ultrasonic generator is provided in the puncture part. A drug solution diffusion promoting device for use in the drug solution diffusion system according to any one of claims 1 to 19,
a drug solution injection tube that is inserted into a target tissue; and a first ultrasonic wave generating unit that is provided in the drug solution injection tube and generates a first ultrasonic wave for diffusing the drug solution;
The first ultrasonic generating unit includes at least two transducers, and the two transducers are provided on a side wall of the drug solution injection tube.

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