WO2023112821A1 - Medical instrument - Google Patents

Medical instrument Download PDF

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Publication number
WO2023112821A1
WO2023112821A1 PCT/JP2022/045273 JP2022045273W WO2023112821A1 WO 2023112821 A1 WO2023112821 A1 WO 2023112821A1 JP 2022045273 W JP2022045273 W JP 2022045273W WO 2023112821 A1 WO2023112821 A1 WO 2023112821A1
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WO
WIPO (PCT)
Prior art keywords
groove
injection needle
wall surface
longitudinal direction
medical device
Prior art date
Application number
PCT/JP2022/045273
Other languages
French (fr)
Japanese (ja)
Inventor
善紀 米田
大貴 有馬
達 末原
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023112821A1 publication Critical patent/WO2023112821A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to medical instruments.
  • percutaneous ethanol injection therapy may be used to locally treat and necrotize cancer cells.
  • the operator makes an incision in the abdomen or chest, pierces the liver with a needle cannula, and makes the tip of the needle reach the affected part of the liver cancer. By injecting ethanol from the tip of the needle, cancer cells can be necrotized.
  • Devices for administering cancer therapeutic agents include apparatus comprising a plurality of needles, a plurality of reservoirs in fluid communication with each of the plurality of needles, and a plurality of actuators for controlling the fluid pressure within the plurality of reservoirs.
  • apparatus comprising a plurality of needles, a plurality of reservoirs in fluid communication with each of the plurality of needles, and a plurality of actuators for controlling the fluid pressure within the plurality of reservoirs.
  • a plurality of holes are provided on the side of the needle through which the medicine can be administered to the outside.
  • an object of the present invention is to provide a medical device capable of increasing the amount of drug accumulated in a target tissue.
  • the present invention is (1) a medical device having an injection needle.
  • the injection needle has an inner wall surface that is formed in a long cylindrical shape and forms a flow path for the drug therein, and an outer wall surface that is formed on the opposite side of the inner wall surface and faces the outside. is closed.
  • the outer wall surface and the inner wall surface are connected by a plurality of holes communicating with the flow path.
  • the outer wall surface is formed in an uneven shape so as to form a groove.
  • the groove is provided so as to longitudinally connect adjacent holes in the plurality of holes.
  • the groove facilitates the inward flow of the drug when the drug flows through the groove in a radial direction that intersects the longitudinal direction of the injection needle.
  • the angle formed by the corners of the cross-sectional shape of the groove is 90 degrees or less when the groove is viewed from the direction in which the groove extends. .
  • the groove may be formed through a first portion connecting the adjacent holes to a second portion beyond the hole. preferable.
  • the holes are formed side by side in the longitudinal direction of the injection needle, and are arranged around the injection needle intersecting the longitudinal direction. It is preferable that the groove portions are formed between the adjacent hole portions in the circumferential direction in addition to the longitudinal direction.
  • the medical device according to any one of (1) to (5) above preferably includes a second groove spaced apart from the hole and formed adjacent to the groove. (7) In the medical device according to any one of (1) to (6) above, it is preferable that the groove is formed to have a width equal to or greater than the width of the hole. (8) In the medical device according to any one of (1) to (6) above, the groove is formed to be smaller than the width of the hole, and is formed to pass through one hole. is preferred. (9) In the medical device according to any one of (1) to (8) above, a plurality of grooves are provided, and among the plurality of grooves, one groove and another groove are formed to have different depths. preferably.
  • the hole is formed in a polygonal shape when viewed from a side crossing the longitudinal direction of the injection needle.
  • the medical device according to any one of the above (1) to (10) is formed adjacent to the hole on the most proximal side in the longitudinal direction of the injection needle, and It is preferable to provide a stopper that inhibits the flow to.
  • the amount of drug accumulated in the target tissue can be increased.
  • FIG. 2 is a diagram showing a tip portion of an injection needle that constitutes the medical system according to FIG. 1; 3 is a cross-sectional view showing the hole and groove in the injection needle of FIG. 2, taken along line 3-3 of FIG. 2 and passing through the axial center of the hole; FIG. 3 is a cross-sectional view along line 4-4 in FIG. 2, showing the groove of the injection needle, in a direction crossing (perpendicular to) the longitudinal direction of the injection needle according to FIG. 2.
  • FIG. FIG. 10 is a diagram showing how a drug flows out from an injection needle according to a comparative example having no groove.
  • FIG. 6 is a diagram showing how the drug flows out from the injection needle according to the comparative example, continued from FIG. 5 ;
  • FIG. 7 is a diagram showing how the medicine flows out from the injection needle according to the comparative example, continued from FIG. 6 ;
  • FIG. 3 is a diagram showing how a drug flows out from the injection needle according to FIG. 2;
  • FIG. 8 is a diagram showing how the drug flows out from the injection needle according to FIG. 2, continued from FIG. 8;
  • FIG. 9 is a diagram showing how the drug flows out from the injection needle according to FIG. 2, continued from FIG. 9;
  • FIG. 6 is a cross-sectional view showing contact between the injection needle and the target tissue in the injection needle according to the comparative example without the groove shown in FIG. 5 , cut along the axial center of the hole.
  • FIG. 3 is a cross-sectional view of the injection needle according to FIG. 2, showing contact between the injection needle and the target tissue, cut along the axial center of the hole.
  • FIG. 10 is a diagram showing a distal end portion of an injection needle according to Modification 1 of the first embodiment; It is sectional drawing which shows the shape of the groove part of the injection needle which concerns on the modified example 2 of 1st Embodiment, and corresponds to FIG. It is sectional drawing which shows the shape of the groove part of the injection needle based on the modified example 3 of 1st Embodiment, and corresponds to FIG. It is sectional drawing which shows the shape of the groove part of the injection needle based on the modified example 4 of 1st Embodiment, and corresponds to FIG.
  • FIG. 10 is a diagram showing a tip portion of an injection needle according to Modification 6 of the first embodiment
  • FIG. 11 is a diagram showing a tip portion of an injection needle according to Modification 7 of the first embodiment
  • FIG. 11 is a diagram showing a tip portion of an injection needle according to Modification 8 of the first embodiment
  • 21 is a cross-sectional view corresponding to FIG. 3, showing the groove and hole of the injection needle according to FIG. 20
  • FIG. FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 9 of the first embodiment
  • FIG. 10 is a diagram showing a tip portion of an injection needle according to Modification 10 of the first embodiment
  • FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 11 of the first embodiment
  • FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 12 of the first embodiment
  • FIG. 13 is a diagram showing a tip portion of an injection needle according to Modification 13 of the first embodiment
  • FIG. 20 is a diagram showing a distal end portion of an injection needle according to Modified Example 14 of the first embodiment
  • FIG. 20 is a diagram showing a distal end portion of an injection needle according to Modification 15 of the first embodiment
  • FIG. 29 is a cross-sectional view corresponding to FIG. 3 showing the groove, hole and stopper of the injection needle according to FIG.
  • FIG. 1 is a schematic diagram showing a medical system 1 according to the first embodiment.
  • FIG. 2 is a diagram showing a tip portion of an injection needle 10 that constitutes the medical system 1.
  • FIG. 3 shows the hole portion 13 and the groove portion 14 of the injection needle 10 according to FIG. 2, and is a cross-sectional view taken along line 3-3 of FIG.
  • FIG. 4 shows the groove portion 14 of the injection needle 10, and is a cross-sectional view taken along line 4-4 in FIG. 2 in a direction crossing (perpendicular to) the longitudinal direction X of the injection needle 10 according to FIG.
  • the longitudinal direction X indicates the direction in which the long injection needle 10 extends, and is referred to as the longitudinal direction X.
  • the radial direction means the same direction as the diameter of the arc of the inner wall surface 11 shown in FIG. 4, and is hereinafter referred to as the radial direction Y (see FIG. 3, etc.).
  • Circumferential direction means the direction in which the inner wall surface 11 and the outer wall surface 12 shown in FIG. 4 extend.
  • the medical system 1 can be used when administering drugs such as anticancer drugs to patients. If the medical system 1 is outlined with reference to FIG. and have The medical system 1 is connected to a liquid-sending pump Lt to perform a drug liquid-sending operation. Infusion needle 10 , inner barrel 20 , and outer barrel 40 may be referred to herein as medical device 100 . Details will be described below.
  • the injection needle 10 is formed in an elongated shape, is configured to be able to pierce a target tissue T such as a tumor site, and is configured to allow distribution of drugs including anticancer drugs.
  • the injection needle 10 is made of a metal material such as SUS304, and has a sharp tip so that it can pierce the target tissue T. As shown in FIG.
  • the injection needle 10 includes an inner wall surface 11, an outer wall surface 12, a hole portion 13, and a groove portion 14, as shown in FIG.
  • the injection needle 10 is formed in an elongated cylindrical shape, and an inner wall surface 11 forms a flow path inside so that the drug can be administered to the target tissue T.
  • the inner wall surface 11 is shaped like a cylindrical side surface except for the hole portion 13 .
  • the specific shape of the inner wall surface other than the hole portion 13 is not limited to the side surface of the cylinder as long as the drug can flow from the base end side of the flow channel to the distal end side toward the hole portion 13. It may be configured by a side surface of
  • the outer wall surface 12 is formed on the side opposite to the inner wall surface 11 and configured to face the outside.
  • the outer wall surface 12 is formed in an uneven shape so as to form grooves 14 .
  • the surface 12a of the outer wall surface 12 other than the hole portion 13 and the groove portion 14 is formed like a cylindrical side surface like the inner wall surface 11. The shape of may not be the side of a cylinder.
  • a plurality of holes 13 are provided so as to communicate with the flow path formed by the inner wall surface 11 and connect the inner wall surface 11 and the outer wall surface 12 .
  • the hole portion 13 is formed along the longitudinal direction X of the cylinder as shown in FIG.
  • the shapes of the portions do not necessarily have to be arranged on the same straight line along the longitudinal direction X.
  • the hole 13 is provided on the cylindrical side surface of the substantially cylindrical injection needle 10, and the cylindrical tip is closed.
  • the hole 13 is formed in a substantially circular shape in this embodiment.
  • a plurality of holes 13 can be provided in the longitudinal direction X and the circumferential direction, and it is preferable to provide three or more in the longitudinal direction X and three or more in the circumferential direction, but the specific number is not limited to the above.
  • the holes 13 are arranged so that adjacent holes 13 are aligned in the longitudinal direction X and the circumferential direction.
  • the injection needle 10 is configured to have a hole 13 and to seal (close) a portion on the distal end side of the hole 13 provided at the most distal end. With this configuration, the drug that has flowed in from the proximal end side of the injection needle 10 does not flow out from the tip of the injection needle 10, but flows out radially from the hole 13 formed in the side surface of the injection needle 10. do.
  • the groove portion 14 is formed in the outer wall surface 12 and is formed so as to be located inside in the radial direction Y from the surrounding surface 12a shown in FIG. 3 and the like.
  • the groove portion 14 is formed along the longitudinal direction X so as to connect adjacent hole portions 13 in the plurality of hole portions 13 .
  • the groove portion 14 is formed so as to extend to the most distal and most proximal hole portions 13 in the hole portion 13 .
  • the groove 14 is configured to form a substantially arcuate recess as shown in FIG. 4 when viewed from the direction in which the groove 14 extends (longitudinal direction X in the present embodiment).
  • the groove portion 14 has a width dimension along the circumferential direction approximately equal to the diameter dimension of the hole portion 13 . That is, the grooves 14 are arranged in a row with respect to the group of holes 13 arranged along the longitudinal direction X. As shown in FIG. A plurality of grooves 14 are provided as shown in FIG. 2, and each groove 14 has the same depth in this embodiment.
  • the outer diameter d1 of the injection needle 10 forming the outer wall surface 12 can be set to 0.70 mm, and the inner diameter d2 of the injection needle 10 forming the inner wall surface 11 can be set to 0.50 mm.
  • the thickness d3 is 0.10 mm (ranging from 0.05 mm to 0.30 mm).
  • the hole diameter d4 of the holes 13 can be set to ⁇ 0.2 mm, and the holes 13 can be arranged at intervals of 4 mm in the longitudinal direction X (the direction in which the holes are arranged).
  • the width d5 of the groove portion 14 can be set to less than 200 ⁇ m, and the depth d6 can be set to 20 to 50 ⁇ m.
  • the depth d6 of the groove 14 is preferably 1/4 to 1/2 of the wall thickness d3 of the injection needle 10, and the width d5 is preferably not more than the depth d6.
  • the processing method of the groove portion 14 is not particularly limited, rolling is preferable from the viewpoint of preventing or suppressing a decrease in strength.
  • the outer surface of the inside of the groove portion 14 is roughened by satin finishing or the like.
  • the injection needle 10 is configured to extend linearly as shown in FIG. 2 in a state where no external force is applied, but it is not limited to this.
  • the material may be configured to have a curved shape when no external force is applied, and may be configured to deform linearly when an external force is applied.
  • the inner cylinder 20 is connected to the proximal end of the injection needle 10 and has an internal space 21 for circulating the drug to the injection needle 10 .
  • a pressure sensor 50 which will be described later, is installed in the internal space 21 of the inner cylinder 20.
  • the inner cylinder 20 is configured to be connectable with the tube 60 , so that the drug sent from the liquid-sending pump Lt can flow into the inner space 21 of the inner cylinder 20 .
  • the cannula 30 is arranged outside the injection needle 10 in the radial direction Y and is configured to be relatively movable in the longitudinal direction X with respect to the injection needle 10 .
  • Cannula 30 may be constructed of similar materials as infusion needle 10 and may also be referred to as a barrel needle.
  • the outer cylinder 40 is integrally formed with the cannula 30, and is configured so that the inner cylinder 20 can be accommodated therein.
  • the outer cylinder 40 and the inner cylinder 20 can be made of plastic such as polypropylene or polyethylene.
  • the pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20 and configured to be able to measure the pressure when the drug is being circulated from the liquid-sending pump Lt to the injection needle 10 .
  • the specific configuration of the pressure sensor 50 is not particularly limited as long as it can measure the pressure of the drug passing through the internal space 21 of the inner cylinder 20, but an example is a diaphragm sensor.
  • the tube 60 forms a flow path through which the drug delivered from the liquid delivery pump Lt is circulated toward the injection needle 10 .
  • the tube 60 is configured to connect the liquid transfer pump Lt and the inner cylinder 20 in this embodiment.
  • Tube 60 may be constructed from any known flexible plastic material.
  • a known valve or the like can be installed in the tube 60 for switching ON/OFF of the flow of liquid feeding.
  • the pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20 in this embodiment, but the location of installation of the pressure sensor is not limited to the internal space of the inner cylinder, and is similar to the internal space of the tube 60 . It may be anywhere along the route of administration in system 1 .
  • the notification unit 70 is configured to be able to notify the user of the determination result of the control unit 80 .
  • the notification unit 70 can adopt various notification methods as long as it can notify the user of the determination result of the control unit 80.
  • the measured values can be displayed in chronological graphs and notified by voice.
  • the control unit 80 is connected to the pressure sensor 50, the liquid-sending pump Lt, and the notification unit 70, and is configured to be able to control the liquid-sending pump Lt and the notification unit 70.
  • the control unit 80 includes processors such as CPU (Central Processing Unit) and GPU (Graphics Processing Unit), main storage such as memory, auxiliary storage such as HDD (Hard Disc Drive) and SSD (Solid State Drive).
  • the liquid-sending pump Lt is connected to the medical system 1 and configured to circulate the drug toward the injection needle 10 .
  • the liquid-sending pump Lt includes a syringe Lt1, a plunger Lt2, and a motor Lt3, as shown in FIG.
  • the syringe Lt1 is provided with an internal space for containing a drug, and is configured so that a pusher Lt2 can be inserted from the base end side, and a tube 60 can be connected to the tip end side.
  • the syringe Lt1 can be configured similarly to the inner cylinder 20 and the like.
  • the plunger Lt2 is configured to be liquid-tightly movable (slidable) while being housed in the internal space of the syringe Lt1. As a result, when the syringe Lt1 is moved in the direction of decreasing the internal space, the medicine can be delivered toward the injection needle 10 through the tube 60 and the inner cylinder 20 .
  • the motor Lt3 is connected to the plunger Lt2 and generates a driving force that moves the plunger Lt2 so that the internal space of the syringe Lt1 changes.
  • the liquid-sending pump Lt generates a driving force for circulating the drug toward the injection needle 10 by driving the motor Lt3 in this embodiment.
  • the operator connects the tube 60 to the inner cylinder 20 and the liquid transfer pump Lt. Then, in a state where the injection needle 10 is not punctured into the target tissue T, the liquid feeding pump Lt is operated, and a priming operation is performed to circulate the drug into the internal space of the injection needle 10 through the internal space of the tube 60 and the internal space 21 of the inner cylinder 20. I do.
  • the purpose of the drug is to administer it to the target tissue T, and sufficient attention should be paid to the handling of the drug that may flow out from the tip of the injection needle 10 during priming.
  • the operator After priming, the operator puts the tip of the injection needle 10 into the internal space of the cannula 30 .
  • the medical device 100 By moving the medical device 100 with the distal end of the injection needle 10 housed in the internal space of the cannula 30, unintentional leakage of the drug during movement can be prevented or suppressed.
  • the operator makes a small incision around the patient's abdomen, percutaneously punctures the cannula 30 from the body surface under ultrasonic echo, and inserts the tip of the injection needle 10 into the tumor site or the like. Move to the vicinity of the target tissue T.
  • the operator exposes the tip of the injection needle 10 from the cannula 30 to the outside and pierces the target tissue T with the tip of the injection needle 10 to administer the drug to the target tissue T.
  • FIG. After the administration of the drug is finished, the operator puts the tip of the injection needle 10 inside the cannula 30 and removes the injection needle 10 and the cannula 30 from the body.
  • the medical device 100 includes an inner wall surface 11 which is formed in a long cylindrical shape and forms a flow path for the medicine to flow therein, and an outer wall surface 12 which is formed on the opposite side of the inner wall surface 11 and faces the outside. and has an injection needle 10 with a closed distal end in the longitudinal direction X.
  • the outer wall surface 12 and the inner wall surface 11 are connected by a plurality of holes 13 communicating with the flow path.
  • the outer wall surface 12 is formed in an uneven shape so as to form a groove portion 14 .
  • the groove portion 14 is provided so as to connect adjacent hole portions 13 in the longitudinal direction X in the plurality of hole portions 13 .
  • FIG. 5 to 7 are views showing how the drug Md flows out from the hole Sp at the tip of the injection needle DL having no groove according to the comparative example
  • FIGS. 8 to 10 are the injection needle 10 according to the present embodiment.
  • FIG. 10 is a diagram showing how the medicine flows out from the hole 13 at the tip of the .
  • 11 is a cross-sectional view showing contact between the injection needle DL and the target tissue T according to the comparative example shown in FIG. 5, and
  • FIG. 12 shows contact between the injection needle 10 and the target tissue T in the injection needle 10 according to this embodiment. It is a sectional view.
  • the medicine Md may flow out separately from the hole Sp and the medicine Md may not spread sufficiently.
  • the amount of the medicine Md flowing out from the hole Sp is likely to be uneven as shown in FIG.
  • the injection needle DL according to the comparative example has a relatively small area from which the drug flows out, and the amount of the drug Md that flows out is likely to be uneven. It may not be possible to administer, resulting in relatively low drug efficacy.
  • the medical device 100 by providing the injection needle 10 with the groove portion 14 as described above, the target tissue T and the injection needle 10 are separated from each other on the outer surface of the injection needle 10 as shown in FIG. It is possible to secure a large liquid surface area through which the medicine Md can flow on the outer surface. As a result, the groove portion 14 can be widely circulated on the outer surface of the injection needle 10, and the drug Md can be widely diffused within the tissue. Further, even if there is a part of the tumor where it is difficult for the drug Md to permeate, the drug Md can flow through the groove 14 to a site where the drug Md can relatively easily permeate.
  • the amount of the medicine Md flowing out from the hole 13 can be made uniform as shown in FIG. This allows the drug Md to act in a wider range by administering the drug Md, thereby improving the efficacy.
  • the groove portion 14 in a concave shape, it is possible to easily reflect the ultrasonic waves emitted from the ultrasonic echo probe. This makes it easy to position the range where a plurality of needle holes exist inside the tumor in the puncture procedure using the ultrasonic echo image, and the visibility of the injection needle 10 can be improved.
  • FIG. 13 is a side view showing an injection needle 10a of a medical device according to Modification 1.
  • the hole 13 has a substantially circular shape when viewed from the side.
  • the specific shape of the hole is not limited to a circle, as long as the drug Md flowing through the flow path, which is the internal space of the injection needle, can be released to the outside.
  • the hole portion 13a can be formed in a polygonal shape such as a rhombus when viewed from the side crossing the longitudinal direction X as shown in FIG.
  • Polygons forming the holes may be other polygons than rhombuses, such as triangles, quadrilaterals other than rhombuses, and hexagons.
  • the configuration of the medical instrument other than the hole portion 13a is the same as that of the first embodiment, and the usage example is also the same as that of the first embodiment, so the description is omitted.
  • the usage examples of Modified Example 2 and later described later are the same as those of the first embodiment, and the configurations different from the first embodiment will be described, and the descriptions of the common configurations and usage examples will be omitted.
  • FIGS. 14 to 17 are diagrams of the groove 14b of the injection needle 10b to the groove 14e of the injection needle 10e of the medical devices according to Modifications 2 to 5 as viewed from the extending direction of the grooves.
  • the shape of the groove 14 when viewed from the longitudinal direction X in which the groove extends is substantially arcuate.
  • the specific shape of the groove is not limited to a substantially arc shape.
  • the groove portion may be configured to include a guide portion that promotes the medicine Md to flow inward in the radial direction Y that intersects the longitudinal direction X of the injection needle when the medicine Md is placed.
  • the angle formed by the corners of the cross-sectional shape of the groove may be 90 degrees or less.
  • the shape of the groove 14b of the injection needle 10b when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a rectangle (Modification 2).
  • the shape of the groove 14c of the injection needle 10c when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a triangular shape (modification example 3).
  • the shape of the groove 14d of the injection needle 10d when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a stepped polygon (Modification 4). .
  • the shape of the groove 14e of the injection needle 10e when viewed from the direction in which the groove extends tends to decrease as the width dimension (the dimension corresponding to the lateral direction in FIG. 17) goes radially outward. You may form in the shape notched by the square (Modification 5).
  • the groove portion 14b of Modification Example 2 to the groove portion 14e of Modification Example 5 promote the inward depression of the liquid surface in the radial direction Y intersecting the longitudinal direction X of the injection needle 10 when the drug is placed. It is equipped with an attracting part.
  • the guiding portion is configured such that the angle formed by the corners of the cross-sectional shape of the groove is 90 degrees or less when the groove is viewed from the direction in which the groove extends, such as the grooves 14b to 14e. With this configuration, as shown in FIGS. 14 to 17, it is possible to prevent the target tissue T from entering the groove and completely blocking the groove. It may facilitate diffusion on the outer surface of the injection needle.
  • FIG. 18 is a side view showing the tip of an injection needle 10f of a medical device according to Modification 6.
  • FIG. 14 of the injection needle 10 is formed along the longitudinal direction X in the first embodiment, the specific aspect of the groove is not limited to the above.
  • the groove portion 14f may be configured to extend spirally on the outer surface of the injection needle as shown in FIG. That is, in this specification, connecting adjacent holes with grooves in the "longitudinal direction" means that the positions of the adjacent holes are not displaced in the circumferential direction and are displaced in the longitudinal direction X. It is not intended only for connecting with each other.
  • the above description also includes the case where adjacent hole portions are displaced not only in the longitudinal direction X but also in the circumferential direction, as shown in FIG. 18 and the like.
  • the groove portion 14f By configuring the groove portion 14f to extend spirally in this way, it is possible to make it easier to reflect ultrasonic waves compared to the case where the groove portion extends in the longitudinal direction X like the groove portion 14.
  • FIG. 19 is a side view showing an injection needle 10g of a medical device according to Modification 7.
  • the injection needle 10g has grooves 14 extending in the longitudinal direction X as in the first embodiment when the holes 13 are arranged side by side in the longitudinal direction X and the circumferential direction as shown in FIG. , and a groove portion 14g between the hole portions 13 adjacent to each other in the circumferential direction.
  • grooves 14g of the injection needle 10g are configured to extend in the circumferential direction, so that ultrasonic waves can be reflected more easily than grooves 14 extending along the longitudinal direction X. As shown in FIG.
  • (Modification 8 to Modification 10) 20 to 23 are diagrams showing the groove 14h of the injection needle 10h of the medical device according to the eighth modification to the groove 14m of the injection needle 10m according to the tenth modification.
  • the grooves 14 are provided up to the holes at the distal end and the proximal end in the longitudinal direction X in the plurality of holes 13 .
  • the groove portion 14h of the injection needle 10h is located on the most distal side or the proximal side in the extending direction of the groove portion as shown in FIGS. (Modification 8).
  • the groove portion 14h is configured to extend to a second portion Pr2 beyond the hole portion 13 through the first portion Pr1 connecting the adjacent hole portions 13 as shown in FIGS. 20 and 21 .
  • the groove portion 14h is configured such that the position of the end on the distal end side extends to a position separated from the distal end of the injection needle.
  • the groove portion 14k of the injection needle 10k may be formed so as to extend to such an extent that the tip position of the second portion Pr2 reaches the tip (blade surface) of the injection needle as shown in FIG. (Modification 9).
  • the form in which the end of the groove is positioned beyond the hole 13 is not limited to the case where the direction in which the groove extends is purely along the longitudinal direction X. It can be applied to the case where a spiral extends (Modification 10).
  • the grooves 14h, 14k, and 14m are configured to pass through the first portion Pr1 connecting the adjacent holes and extend to the second portion Pr2 beyond the holes. Such a configuration can further improve the diffusibility of the drug.
  • FIG. 11 is a side view showing grooves of medical instruments according to modified examples 11 and 12.
  • FIG. 1 it has been described that the grooves 14 are formed so as to connect the adjacent holes 13 .
  • the groove portion may be configured to include a groove portion (corresponding to a second groove portion) formed adjacent to the groove portion 14 while being separated from the hole portion 13 .
  • a specific aspect of the second groove portion is not limited to the case where the second groove portion extends in the longitudinal direction X like the groove portion 15 of the injection needle 10n shown in FIG.
  • a case where the second groove portion extends in the circumferential direction like the groove portion 15p of 10p (Modification 12) can also be included.
  • the groove portion 15p is formed so as to intersect with the groove portion 14. As shown in FIG.
  • the injection needle is provided with grooves 15 and grooves 15p, which are separated from the hole 13 and are formed adjacent to the grooves 14, so that the drug is diffused. can improve sexuality. Also, the visibility of the injection needle under the ultrasonic echo image can be improved.
  • FIG. 26 is a side view showing an injection needle 10q of a medical device according to modification 13.
  • the specification of the groove portion is not limited to this, and the groove portion 14q may be configured to be larger than the width dimension of the hole portion 13 other than the above.
  • the contact area of the drug Md released from the hole portion 13 with the target tissue T is increased, thereby improving the diffusibility of the drug, It is possible to improve the visibility (contrastability) in the acoustic echo image.
  • FIG. 27 is a side view showing an injection needle 10r of a medical device according to modification 14.
  • FIG. 1 it has been described that the grooves 14 are formed in a line with respect to the group of holes 13 arranged in the longitudinal direction X. As shown in FIG.
  • the specific configuration of the grooves is not limited to the case where a row of grooves is provided in the group of holes 13 .
  • the grooves may be formed to have a width smaller than that of one hole 13 like the grooves 14r1 and 14r2 in FIG.
  • the diffusibility of the medicine Md can be improved.
  • the visibility (contrastability) of the injection needle under the ultrasonic echo image can be improved.
  • Modification 15 to Modification 17 28 and 29 are a side view and a sectional view showing an injection needle 10s of a medical device according to Modification 15, and FIGS. 30 and 31 are a side view and a sectional view showing an injection needle 10t of a medical device according to Modification 16.
  • 32 and 33 are a side view and a cross-sectional view showing an injection needle 10u of a medical device according to modification 17.
  • the injection needle 10 is provided with the groove 14 in order to improve the diffusion of the drug Md within the target tissue T such as a tumor.
  • the injection needle may be provided with a stopper that prevents the drug Md released from the holes 13 from flowing to the proximal side of the outer wall surface 12 .
  • a convex shape corresponding to the stopper 16 is formed adjacent to the proximal side of the hole 13 which is the most proximal side among the holes 13 .
  • the convex shape of the stopper 16 protrudes radially outward from the surface 12 a surrounding the groove portion 14 .
  • the width of the convex shape of the stopper 16 is not limited to the case where it is configured to be equal to or less than the diameter of the hole portion 13 as shown in FIG. 28 and the like.
  • the width of the convex shape may be made larger than the diameter dimension of the hole portion 13 like the stopper 16t in FIGS. 30 and 31 (Modification 16).
  • the shape of the stopper may be formed so as to be recessed radially inward from the surface 12a surrounding the groove 14 of the injection needle 10u, like the stopper 16u in FIGS. 32 and 33 (Modification 17).
  • the stoppers 16, 16t, and 16u on the injection needles 10s, 10t, and 10u according to Modifications 15 to 17 leakage of the drug from the puncture site is prevented, and the drug in the target tissue T such as a tumor is prevented. Diffusion of Md can be promoted.
  • FIG. 34 is a side view showing the tip of an injection needle 10v according to Modification 18
  • FIG. 35 is a side view showing the tip of an injection needle 10w according to Modification 19. As shown in FIG. 34
  • the holes 13 are arranged so as to be aligned with adjacent holes in the longitudinal direction X or the circumferential direction.
  • a group of holes arranged in the longitudinal direction X is defined as a first group
  • the holes in the first group 13R1 and the holes in the first group 13R2 of the injection needle 10v are positioned in the longitudinal direction X as shown in FIG. may be shifted (modification 18).
  • the holes in the second group 13C1 and the holes in the second group 13C2 of the injection needle 10w are positioned in the circumferential direction as shown in FIG. You may comprise so that it may be shifted (modification 19).
  • the groove portion 14w of the injection needle 10w is formed so as to be displaced not only in the longitudinal direction X but also in the circumferential direction so as to connect adjacent holes.
  • the plurality of grooves are formed to have the same depth.
  • the plurality of grooves may be configured such that the depths of the grooves are different from each other.
  • the relatively deep groove mainly functions as a passage for the drug between the needle holes, and the relatively shallow groove increases the surface area when the target tissue T abuts. can be made to function mainly in

Abstract

[Problem] To provide a medical instrument with which it is possible to increase the amount of drug uptake in a target tissue. [Solution] This invention: is provided with an inner wall surface 11 that describes the form of a elongated cylinder and forms a channel through which a drug is channelled, and an outer wall surface 12 that is formed on the opposite side to the inner wall surface and faces the exterior; and has an injection needle 10 in which the tip section in the longitudinal direction X is closed. The inner wall surface and the outer wall surface are connected by a plurality of holes 13 communicating with the channel. The outer wall surface is formed in a concavo-convex shape so as to form grooves 14. The grooves are provided so as to connect, in the longitudinal direction, adjacent holes from among the plurality of holes.

Description

医療器具medical instruments
　本発明は、医療器具に関する。 The present invention relates to medical instruments.
　肝臓に形成された腫瘍を処置する場合、局所的に治療を施してがん細胞を壊死させる経皮的エタノール注入療法を行う場合がある。術者は、腹部や胸部を切開し、肝臓に針カニューレを穿刺して、針先を肝臓がんの患部へ到達させる。そして、針先からエタノールを注入することによって、がん細胞を壊死させることができる。 When treating tumors formed in the liver, percutaneous ethanol injection therapy may be used to locally treat and necrotize cancer cells. The operator makes an incision in the abdomen or chest, pierces the liver with a needle cannula, and makes the tip of the needle reach the affected part of the liver cancer. By injecting ethanol from the tip of the needle, cancer cells can be necrotized.
　がん治療薬を投与するデバイスには、複数の針と、複数の針のそれぞれと流体連通する複数のタンクと、複数のタンク内の流体圧力を制御する複数のアクチュエータと、を備える装置がある。この装置において、針の側面には薬剤を外部に投与しうる穴部を複数設けたものが開示されている。 Devices for administering cancer therapeutic agents include apparatus comprising a plurality of needles, a plurality of reservoirs in fluid communication with each of the plurality of needles, and a plurality of actuators for controlling the fluid pressure within the plurality of reservoirs. . In this device, it is disclosed that a plurality of holes are provided on the side of the needle through which the medicine can be administered to the outside.
特開２０１６－０７３７６２号公報JP 2016-073762 A
　本発明者らは、がん治療薬などの薬剤の薬効を向上させるにあたり、腫瘍などの標的組織に対する薬剤の集積量を高めることについて鋭意検討している。そこで本発明は標的組織に対する薬剤の集積量を高め得る医療器具を提供することを目的する。 In order to improve the efficacy of drugs such as cancer therapeutic drugs, the present inventors are earnestly studying how to increase the amount of drugs accumulated in target tissues such as tumors. SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a medical device capable of increasing the amount of drug accumulated in a target tissue.
　本発明は、（１）注入針を備える医療器具である。注入針は、長尺の筒状に形成され内部に薬剤が流通する流路を形成する内壁面と、内壁面と反対側に形成され、外部に臨む外壁面とを備え、長手方向における先端部が閉じている。外壁面と内壁面とは、流路と連通する複数の穴部によって接続される。外壁面は、溝部を形成するように凹凸状に形成される。溝部は、複数の穴部において隣接する穴部を長手方向につなげるように設けられる。
ここで、本発明の実施形態として、
（２）上記（１）の医療器具において、前記溝部は、前記溝部に薬剤が流通する際の薬剤が前記注入針の前記長手方向と交差する径方向における内側に向かって流通することを促進する誘引部を備えることが好ましい。
（３）上記（２）の医療器具において、前記誘引部は、前記溝部の延びる方向から前記溝部を見た際に、前記溝部の断面形状における隅のなす角度が９０度以下であることが好ましい。
（４）上記（１）～（３）のいずれかの医療器具において、前記溝部は、隣接する前記穴部をつなぐ第１部位を通じ、前記穴部を超えた第２部位まで形成されることが好ましい。
（５）上記（１）～（４）のいずれかの医療器具において、前記穴部は、前記注入針の前記長手方向に並んで形成されるとともに、前記長手方向と交差する前記注入針の周方向に並んで形成され、前記溝部は、前記長手方向に加えて前記周方向において隣接する前記穴部の間に形成されることが好ましい。
（６）上記（１）～（５）のいずれかに記載の医療器具は、前記穴部から離間するとともに、前記溝部に隣接して形成される第２溝部を備えることが好ましい。
（７）上記（１）～（６）のいずれかの医療器具において、前記溝部は、前記穴部の幅以上に形成されることが好ましい。
（８）上記（１）～（６）のいずれかの医療器具において、前記溝部は、前記穴部の幅よりも小さく形成され、かつ、一の前記穴部を複数通るように形成されることが好ましい。
（９）上記（１）～（８）のいずれかの医療器具において、前記溝部は複数設けられ、複数の前記溝部において、一の前記溝部と他の前記溝部の深さは互いに異なるように形成されることが好ましい。
（１０）上記（１）～（９）のいずれかの医療器具において、前記穴部は、前記注入針の前記長手方向と交差する側方からみた際に多角形に形成されることが好ましい。
（１１）上記（１）～（１０）のいずれかの医療器具は、前記注入針の前記長手方向において最も基端側の前記穴部に隣接して形成され薬剤の前記外壁面における基端側への流通を阻害するストッパーを備えることが好ましい。 The present invention is (1) a medical device having an injection needle. The injection needle has an inner wall surface that is formed in a long cylindrical shape and forms a flow path for the drug therein, and an outer wall surface that is formed on the opposite side of the inner wall surface and faces the outside. is closed. The outer wall surface and the inner wall surface are connected by a plurality of holes communicating with the flow path. The outer wall surface is formed in an uneven shape so as to form a groove. The groove is provided so as to longitudinally connect adjacent holes in the plurality of holes.
Here, as an embodiment of the present invention,
(2) In the medical device according to (1) above, the groove facilitates the inward flow of the drug when the drug flows through the groove in a radial direction that intersects the longitudinal direction of the injection needle. It is preferable to have an attracting part.
(3) In the medical device of (2) above, it is preferable that the angle formed by the corners of the cross-sectional shape of the groove is 90 degrees or less when the groove is viewed from the direction in which the groove extends. .
(4) In the medical device according to any one of (1) to (3) above, the groove may be formed through a first portion connecting the adjacent holes to a second portion beyond the hole. preferable.
(5) In the medical device according to any one of (1) to (4) above, the holes are formed side by side in the longitudinal direction of the injection needle, and are arranged around the injection needle intersecting the longitudinal direction. It is preferable that the groove portions are formed between the adjacent hole portions in the circumferential direction in addition to the longitudinal direction.
(6) The medical device according to any one of (1) to (5) above preferably includes a second groove spaced apart from the hole and formed adjacent to the groove.
(7) In the medical device according to any one of (1) to (6) above, it is preferable that the groove is formed to have a width equal to or greater than the width of the hole.
(8) In the medical device according to any one of (1) to (6) above, the groove is formed to be smaller than the width of the hole, and is formed to pass through one hole. is preferred.
(9) In the medical device according to any one of (1) to (8) above, a plurality of grooves are provided, and among the plurality of grooves, one groove and another groove are formed to have different depths. preferably.
(10) In the medical device according to any one of (1) to (9) above, it is preferable that the hole is formed in a polygonal shape when viewed from a side crossing the longitudinal direction of the injection needle.
(11) The medical device according to any one of the above (1) to (10) is formed adjacent to the hole on the most proximal side in the longitudinal direction of the injection needle, and It is preferable to provide a stopper that inhibits the flow to.
　本発明の一態様に係る医療器具によれば、標的組織に対する薬剤の集積量を高めることができる。 According to the medical device according to one aspect of the present invention, the amount of drug accumulated in the target tissue can be increased.
本発明の第１実施形態に係る医療システムを示す概略図である。It is a schematic diagram showing a medical system concerning a 1st embodiment of the present invention. 図１に係る医療システムを構成する注入針の先端部を示す図である。FIG. 2 is a diagram showing a tip portion of an injection needle that constitutes the medical system according to FIG. 1; 図２に係る注入針における穴部及び溝部について示し、図２の３－３線に沿って穴部の軸中心を通るように切断した断面図である。3 is a cross-sectional view showing the hole and groove in the injection needle of FIG. 2, taken along line 3-3 of FIG. 2 and passing through the axial center of the hole; FIG. 注入針の溝部について示し、図２に係る注入針の長手方向に交差（直交）する方向であって図２の４－４線に沿う断面図である。3 is a cross-sectional view along line 4-4 in FIG. 2, showing the groove of the injection needle, in a direction crossing (perpendicular to) the longitudinal direction of the injection needle according to FIG. 2. FIG. 溝部のない比較例に係る注入針において薬剤が流出する様子を示す図である。FIG. 10 is a diagram showing how a drug flows out from an injection needle according to a comparative example having no groove. 図５に続き、比較例に係る注入針において薬剤が流出する様子を示す図である。FIG. 6 is a diagram showing how the drug flows out from the injection needle according to the comparative example, continued from FIG. 5 ; 図６に続き、比較例に係る注入針において薬剤が流出する様子を示す図である。FIG. 7 is a diagram showing how the medicine flows out from the injection needle according to the comparative example, continued from FIG. 6 ; 図２に係る注入針において薬剤が流出する様子を示す図である。FIG. 3 is a diagram showing how a drug flows out from the injection needle according to FIG. 2; 図８に続き、図２に係る注入針において薬剤が流出する様子を示す図である。FIG. 8 is a diagram showing how the drug flows out from the injection needle according to FIG. 2, continued from FIG. 8; 図９に続き、図２に係る注入針において薬剤が流出する様子を示す図である。FIG. 9 is a diagram showing how the drug flows out from the injection needle according to FIG. 2, continued from FIG. 9; 図５に示す溝部のない比較例に係る注入針において注入針と標的組織との接触を示し、穴部の軸中心を通るように切断した断面図である。FIG. 6 is a cross-sectional view showing contact between the injection needle and the target tissue in the injection needle according to the comparative example without the groove shown in FIG. 5 , cut along the axial center of the hole. 図２に係る注入針において、注入針と標的組織との接触について示し、穴部の軸中心を通るように切断した断面図である。FIG. 3 is a cross-sectional view of the injection needle according to FIG. 2, showing contact between the injection needle and the target tissue, cut along the axial center of the hole. 第１実施形態の変形例１に係る注入針の先端部を示す図である。FIG. 10 is a diagram showing a distal end portion of an injection needle according to Modification 1 of the first embodiment; 第１実施形態の変形例２に係る注入針の溝部の形状について示し、図４に対応する断面図である。It is sectional drawing which shows the shape of the groove part of the injection needle which concerns on the modified example 2 of 1st Embodiment, and corresponds to FIG. 第１実施形態の変形例３に係る注入針の溝部の形状について示し、図４に対応する断面図である。It is sectional drawing which shows the shape of the groove part of the injection needle based on the modified example 3 of 1st Embodiment, and corresponds to FIG. 第１実施形態の変形例４に係る注入針の溝部の形状について示し、図４に対応する断面図である。It is sectional drawing which shows the shape of the groove part of the injection needle based on the modified example 4 of 1st Embodiment, and corresponds to FIG. 第１実施形態の変形例５に係る注入針の溝部の形状について示し、図４に対応する断面図である。It is sectional drawing which shows the shape of the groove part of the injection needle based on the modification 5 of 1st Embodiment, and corresponds to FIG. 第１実施形態の変形例６に係る注入針の先端部を示す図である。FIG. 10 is a diagram showing a tip portion of an injection needle according to Modification 6 of the first embodiment; 第１実施形態の変形例７に係る注入針の先端部を示す図である。FIG. 11 is a diagram showing a tip portion of an injection needle according to Modification 7 of the first embodiment; 第１実施形態の変形例８に係る注入針の先端部を示す図である。FIG. 11 is a diagram showing a tip portion of an injection needle according to Modification 8 of the first embodiment; 図２０に係る注入針の溝部及び穴部について示し、図３に対応する断面図である。21 is a cross-sectional view corresponding to FIG. 3, showing the groove and hole of the injection needle according to FIG. 20; FIG. 第１実施形態の変形例９に係る注入針の先端部を示す図である。FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 9 of the first embodiment; 第１実施形態の変形例１０に係る注入針の先端部を示す図である。FIG. 10 is a diagram showing a tip portion of an injection needle according to Modification 10 of the first embodiment; 第１実施形態の変形例１１に係る注入針の先端部を示す図である。FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 11 of the first embodiment; 第１実施形態の変形例１２に係る注入針の先端部を示す図である。FIG. 12 is a diagram showing a tip portion of an injection needle according to Modification 12 of the first embodiment; 第１実施形態の変形例１３に係る注入針の先端部を示す図である。FIG. 13 is a diagram showing a tip portion of an injection needle according to Modification 13 of the first embodiment; 第１実施形態の変形例１４に係る注入針の先端部を示す図である。FIG. 20 is a diagram showing a distal end portion of an injection needle according to Modified Example 14 of the first embodiment; 第１実施形態の変形例１５に係る注入針の先端部を示す図である。FIG. 20 is a diagram showing a distal end portion of an injection needle according to Modification 15 of the first embodiment; 図２８に係る注入針の溝部、穴部及びストッパーについて示し、図３に対応する断面図である。FIG. 29 is a cross-sectional view corresponding to FIG. 3 showing the groove, hole and stopper of the injection needle according to FIG. 28; 第１実施形態の変形例１６に係る注入針の先端部を示す図である。FIG. 20 is a diagram showing a tip portion of an injection needle according to Modification 16 of the first embodiment; 図３０に係る注入針の溝部、穴部及びストッパーについて示し、図３に対応する断面図である。31 is a cross-sectional view corresponding to FIG. 3, showing the groove, hole and stopper of the injection needle according to FIG. 30; FIG. 第１実施形態の変形例１７に係る注入針の先端部を示す図である。FIG. 21 is a diagram showing a distal end portion of an injection needle according to Modification 17 of the first embodiment; 図３２に係る注入針の溝部、穴部及びストッパーについて示し、図３に対応する断面図である。Fig. 33 is a cross-sectional view corresponding to Fig. 3, showing the groove, hole and stopper of the injection needle according to Fig. 32; 第１実施形態の変形例１８に係る注入針の先端部を示す図である。FIG. 20 is a diagram showing a tip portion of an injection needle according to Modification 18 of the first embodiment; 第１実施形態の変形例１９に係る注入針の先端部を示す図である。FIG. 20 is a diagram showing a distal end portion of an injection needle according to Modification 19 of the first embodiment;
　以下、本発明を実施するための形態について、図面を参照しながら詳細に説明する。ここで示す実施形態は、本発明の技術的思想を具体化するために例示するものであって、本発明を限定するものではない。また、本発明の要旨を逸脱しない範囲で当業者などにより考え得る実施可能な他の形態、実施例および運用技術などは全て本発明の範囲、要旨に含まれると共に、特許請求の範囲に記載された発明とその均等の範囲に含まれる。 Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. included within the scope of the claimed invention and its equivalents.
　さらに、本明細書に添付する図面は、図示と理解のしやすさの便宜上、適宜縮尺、縦横の寸法比、形状などについて、実物から変更し模式的に表現される場合があるが、あくまで一例であって、本発明の解釈を限定するものではない。 Furthermore, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.
　また、以下の説明において、「第１」、「第２」のような序数詞を付して説明するが、特に言及しない限り、便宜上用いるものであって何らかの順序を規定するものではない。 Also, in the following description, ordinal numbers such as "first" and "second" will be used, but unless otherwise specified, they are used for convenience and do not prescribe any order.
　（第１実施形態）
　以下、図１から図４を参照して第１実施形態に係る医療システム１について説明する。図１は第１実施形態に係る医療システム１を示す概略図である。図２は医療システム１を構成する注入針１０の先端部を示す図である。図３は図２に係る注入針１０の穴部１３及び溝部１４について示し、図２の３－３線に沿って穴部１３の軸中心を通るように切断した断面図である。図４は注入針１０の溝部１４について示し、図２に係る注入針１０の長手方向Ｘに交差（直交）する方向であって図２の４－４線に沿う断面図である。 (First embodiment)
A medical system 1 according to the first embodiment will be described below with reference to FIGS. 1 to 4. FIG. FIG. 1 is a schematic diagram showing a medical system 1 according to the first embodiment. FIG. 2 is a diagram showing a tip portion of an injection needle 10 that constitutes the medical system 1. As shown in FIG. FIG. 3 shows the hole portion 13 and the groove portion 14 of the injection needle 10 according to FIG. 2, and is a cross-sectional view taken along line 3-3 of FIG. FIG. 4 shows the groove portion 14 of the injection needle 10, and is a cross-sectional view taken along line 4-4 in FIG. 2 in a direction crossing (perpendicular to) the longitudinal direction X of the injection needle 10 according to FIG.
　なお、本明細書において長手方向Ｘとは長尺の注入針１０の延在する方向を示し、長手方向Ｘと称する。また、径方向とは、図４に示す内壁面１１の円弧の径と同様の方向を意味し、以下、径方向Ｙと称する（図３等参照）。また、周方向とは、図４に示す内壁面１１や外壁面１２の延びる方向を意味する。 In this specification, the longitudinal direction X indicates the direction in which the long injection needle 10 extends, and is referred to as the longitudinal direction X. The radial direction means the same direction as the diameter of the arc of the inner wall surface 11 shown in FIG. 4, and is hereinafter referred to as the radial direction Y (see FIG. 3, etc.). Circumferential direction means the direction in which the inner wall surface 11 and the outer wall surface 12 shown in FIG. 4 extend.
　本実施形態に係る医療システム１は抗がん剤等の薬剤を患者に投与する際に利用することができる。図１を参照して医療システム１について概説すれば、注入針１０と、内筒２０と、カニューレ３０と、外筒４０と、圧力センサ５０と、チューブ６０と、通知部７０と、制御部８０と、を有する。医療システム１は、送液ポンプＬｔに接続されて薬剤の送液動作を行う。本明細書において注入針１０、内筒２０、及び外筒４０は医療器具１００と称し得る。以下、詳述する。 The medical system 1 according to this embodiment can be used when administering drugs such as anticancer drugs to patients. If the medical system 1 is outlined with reference to FIG. and have The medical system 1 is connected to a liquid-sending pump Lt to perform a drug liquid-sending operation. Infusion needle 10 , inner barrel 20 , and outer barrel 40 may be referred to herein as medical device 100 . Details will be described below.
　注入針１０は長尺状に形成し、腫瘍部位等の標的組織Ｔに穿刺可能に構成され、抗がん剤を含む薬剤を流通可能に構成している。注入針１０はＳＵＳ３０４のような金属材料等によって形成され、先端が標的組織Ｔに穿刺できるように鋭利に構成している。 The injection needle 10 is formed in an elongated shape, is configured to be able to pierce a target tissue T such as a tumor site, and is configured to allow distribution of drugs including anticancer drugs. The injection needle 10 is made of a metal material such as SUS304, and has a sharp tip so that it can pierce the target tissue T. As shown in FIG.
　注入針１０は、図３等に示すように内壁面１１と、外壁面１２と、穴部１３と、溝部１４と、を備える。注入針１０は長尺の筒状に形成され、内壁面１１によって薬剤を標的組織Ｔに投与できるように内部に流路を形成している。内壁面１１は、本実施形態において穴部１３以外の形状を円筒の側面のように形成している。ただし、薬剤を流路の基端側から穴部１３に向かって先端側に流通できれば、穴部１３以外の内壁面の具体的な形状は円筒の側面に限定されず、上記以外にも多角柱の側面等によって構成してもよい。 The injection needle 10 includes an inner wall surface 11, an outer wall surface 12, a hole portion 13, and a groove portion 14, as shown in FIG. The injection needle 10 is formed in an elongated cylindrical shape, and an inner wall surface 11 forms a flow path inside so that the drug can be administered to the target tissue T. As shown in FIG. In this embodiment, the inner wall surface 11 is shaped like a cylindrical side surface except for the hole portion 13 . However, the specific shape of the inner wall surface other than the hole portion 13 is not limited to the side surface of the cylinder as long as the drug can flow from the base end side of the flow channel to the distal end side toward the hole portion 13. It may be configured by a side surface of
　外壁面１２は、内壁面１１と反対側に形成され、外部に臨むように構成している。外壁面１２は、溝部１４を形成するように凹凸状に形成している。穴部１３及び溝部１４以外の外壁面１２の面１２ａは内壁面１１と同様に円筒形状の側面のように形成しているが、内壁面１１と同様に穴部１３及び溝部１４以外の面１２ａの形状は円筒の側面でなくてもよい。 The outer wall surface 12 is formed on the side opposite to the inner wall surface 11 and configured to face the outside. The outer wall surface 12 is formed in an uneven shape so as to form grooves 14 . The surface 12a of the outer wall surface 12 other than the hole portion 13 and the groove portion 14 is formed like a cylindrical side surface like the inner wall surface 11. The shape of may not be the side of a cylinder.
　穴部１３は、内壁面１１の形成する流路と連通し、内壁面１１と外壁面１２とを接続するように複数設けるように構成している。穴部１３は、本実施形態において図２に示すように円筒の長手方向Ｘに沿って形成するように構成しているが、注入針１０の流路に流通する薬剤を外部に放出できれば、穴部の形状は必ずしも長手方向Ｘに沿って同一直線上に並べるように配置していなくてもよい。穴部１３は略筒形状のような注入針１０の筒形状の側面に設けており、筒形状の先端部は閉じるように形成している。 A plurality of holes 13 are provided so as to communicate with the flow path formed by the inner wall surface 11 and connect the inner wall surface 11 and the outer wall surface 12 . In this embodiment, the hole portion 13 is formed along the longitudinal direction X of the cylinder as shown in FIG. The shapes of the portions do not necessarily have to be arranged on the same straight line along the longitudinal direction X. The hole 13 is provided on the cylindrical side surface of the substantially cylindrical injection needle 10, and the cylindrical tip is closed.
　穴部１３は本実施形態において略円形に形成している。穴部１３は、長手方向Ｘおよび周方向に複数設けることができ、長手方向Ｘに３つ以上、周方向に３つ以上設けることが好ましいが、具体的な個数は上記に限定されない。穴部１３は、本実施形態において長手方向Ｘおよび周方向において隣接する穴部１３の位置が揃うように配置している。注入針１０は、穴部１３を設ける一方で最先端に設けられた穴部１３から更に先端側の部位は封止する（閉じる）ように構成している。このように構成することで、注入針１０の基端側から流入してきた薬剤は、注入針１０の先端からは流出せず、注入針１０の側面に形成された穴部１３から径方向に流出する。 The hole 13 is formed in a substantially circular shape in this embodiment. A plurality of holes 13 can be provided in the longitudinal direction X and the circumferential direction, and it is preferable to provide three or more in the longitudinal direction X and three or more in the circumferential direction, but the specific number is not limited to the above. In this embodiment, the holes 13 are arranged so that adjacent holes 13 are aligned in the longitudinal direction X and the circumferential direction. The injection needle 10 is configured to have a hole 13 and to seal (close) a portion on the distal end side of the hole 13 provided at the most distal end. With this configuration, the drug that has flowed in from the proximal end side of the injection needle 10 does not flow out from the tip of the injection needle 10, but flows out radially from the hole 13 formed in the side surface of the injection needle 10. do.
　溝部１４は、外壁面１２に形成され、図３等に示す周囲の面１２ａよりも径方向Ｙの内方に位置するように形成している。溝部１４は、複数の穴部１３において隣接する穴部１３を長手方向Ｘにつなぐように長手方向Ｘに沿って形成している。溝部１４は、穴部１３の中で最先端および最も基端の穴部１３まで設けるように形成している。溝部１４は、本実施形態において溝部１４の延びる方向（本実施形態では長手方向Ｘ）から見た状態において図４に示すように略円弧形状の凹部を形成するように構成している。溝部１４は、本実施形態において周方向に沿う幅寸法を穴部１３の径寸法と同程度に構成している。すなわち、溝部１４は、長手方向Ｘに沿って並ぶ一群の穴部１３に対して一列設けるように構成している。溝部１４は、図２に示すように複数設けており、各々の溝部１４は本実施形態において深さを同一に構成している。 The groove portion 14 is formed in the outer wall surface 12 and is formed so as to be located inside in the radial direction Y from the surrounding surface 12a shown in FIG. 3 and the like. The groove portion 14 is formed along the longitudinal direction X so as to connect adjacent hole portions 13 in the plurality of hole portions 13 . The groove portion 14 is formed so as to extend to the most distal and most proximal hole portions 13 in the hole portion 13 . In the present embodiment, the groove 14 is configured to form a substantially arcuate recess as shown in FIG. 4 when viewed from the direction in which the groove 14 extends (longitudinal direction X in the present embodiment). In the present embodiment, the groove portion 14 has a width dimension along the circumferential direction approximately equal to the diameter dimension of the hole portion 13 . That is, the grooves 14 are arranged in a row with respect to the group of holes 13 arranged along the longitudinal direction X. As shown in FIG. A plurality of grooves 14 are provided as shown in FIG. 2, and each groove 14 has the same depth in this embodiment.
　ここで、図２、図３等を参照して穴部１３および溝部１４の仕様について例示するが、あくまで例示であって注入針の構成は以下の内容に限定されない。外壁面１２を形成する注入針１０の外径ｄ１は０．７０ｍｍ、内壁面１１を形成する注入針１０の内径ｄ２は０．５０ｍｍに構成できる。上記の場合、肉厚ｄ３は０．１０ｍｍ（範囲にして０．０５ｍｍ～０．３０ｍｍ）となる。また、穴部１３については穴径ｄ４をφ０．２ｍｍに設定でき、穴部１３は長手方向Ｘ（穴部の並ぶ方向）に４ｍｍ間隔で配置できる。溝部１４については、溝部１４の幅ｄ５を２００μｍ未満に設定し、深さｄ６を２０～５０μｍに設定できる。 Here, the specifications of the hole portion 13 and the groove portion 14 will be illustrated with reference to FIGS. The outer diameter d1 of the injection needle 10 forming the outer wall surface 12 can be set to 0.70 mm, and the inner diameter d2 of the injection needle 10 forming the inner wall surface 11 can be set to 0.50 mm. In the above case, the thickness d3 is 0.10 mm (ranging from 0.05 mm to 0.30 mm). Further, the hole diameter d4 of the holes 13 can be set to φ0.2 mm, and the holes 13 can be arranged at intervals of 4 mm in the longitudinal direction X (the direction in which the holes are arranged). Regarding the groove portion 14, the width d5 of the groove portion 14 can be set to less than 200 μm, and the depth d6 can be set to 20 to 50 μm.
　溝部１４の寸法は、幅ｄ５に比べて深さｄ６の寸法が大きい方が毛細管現象を生じさせやすく、これにより溝部における薬剤の流通を促進させ得る。溝部１４の深さｄ６は、具体的には注入針１０の肉厚ｄ３の１／４～１／２、幅ｄ５は深さｄ６以下であることが好ましい。また、溝部１４の加工方法は特に限定されないが、強度の低下を防止または抑制する観点から転造が好ましい。さらに、溝部１４の内部の外表面は梨地処理等によって粗面に仕上げることが好ましい。 Regarding the dimension of the groove portion 14, when the depth d6 is larger than the width d5, capillary action is likely to occur, which can promote the distribution of the medicine in the groove portion. Specifically, the depth d6 of the groove 14 is preferably 1/4 to 1/2 of the wall thickness d3 of the injection needle 10, and the width d5 is preferably not more than the depth d6. Moreover, although the processing method of the groove portion 14 is not particularly limited, rolling is preferable from the viewpoint of preventing or suppressing a decrease in strength. Furthermore, it is preferable that the outer surface of the inside of the groove portion 14 is roughened by satin finishing or the like.
　なお、注入針１０は本実施形態において外力を付与していない状態において図２に示すように直線的に延在するように構成しているが、これに限定されない。上記以外にも外力を付与しない状態に湾曲した形状となるように材料を構成し、外力を付与することで直線状に変形するように構成してもよい。 In this embodiment, the injection needle 10 is configured to extend linearly as shown in FIG. 2 in a state where no external force is applied, but it is not limited to this. In addition to the above, the material may be configured to have a curved shape when no external force is applied, and may be configured to deform linearly when an external force is applied.
　内筒２０は、注入針１０の基端部と接続され、薬剤を注入針１０に流通させる内部空間２１を設けている。内筒２０の内部空間２１には後述する圧力センサ５０を設置するように構成している。内筒２０はチューブ６０を接続可能に構成しており、これにより送液ポンプＬｔから送られる薬剤を内筒２０の内部空間２１に流通できる。 The inner cylinder 20 is connected to the proximal end of the injection needle 10 and has an internal space 21 for circulating the drug to the injection needle 10 . A pressure sensor 50, which will be described later, is installed in the internal space 21 of the inner cylinder 20. As shown in FIG. The inner cylinder 20 is configured to be connectable with the tube 60 , so that the drug sent from the liquid-sending pump Lt can flow into the inner space 21 of the inner cylinder 20 .
　カニューレ３０は、注入針１０の径方向Ｙにおける外方に配置され、注入針１０に対して長手方向Ｘに相対的に移動可能に構成している。カニューレ３０は注入針１０と同様の材料で構成でき、外筒針とも呼ばれ得る。外筒４０はカニューレ３０と一体に構成され、内筒２０を内部に収容可能に構成している。外筒４０及び内筒２０は、ポリプロピレンやポリエチレンなどのプラスチックによって構成できる。 The cannula 30 is arranged outside the injection needle 10 in the radial direction Y and is configured to be relatively movable in the longitudinal direction X with respect to the injection needle 10 . Cannula 30 may be constructed of similar materials as infusion needle 10 and may also be referred to as a barrel needle. The outer cylinder 40 is integrally formed with the cannula 30, and is configured so that the inner cylinder 20 can be accommodated therein. The outer cylinder 40 and the inner cylinder 20 can be made of plastic such as polypropylene or polyethylene.
　圧力センサ５０は、内筒２０の内部空間２１に設置され、送液ポンプＬｔから注入針１０に薬剤を流通させている際の圧力を測定可能に構成している。圧力センサ５０は、内筒２０の内部空間２１を通過する薬剤の圧力を測定できれば具体的な構成は特に限定されないが、一例としてダイヤフラム式のセンサを挙げることができる。 The pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20 and configured to be able to measure the pressure when the drug is being circulated from the liquid-sending pump Lt to the injection needle 10 . The specific configuration of the pressure sensor 50 is not particularly limited as long as it can measure the pressure of the drug passing through the internal space 21 of the inner cylinder 20, but an example is a diaphragm sensor.
　チューブ６０は、送液ポンプＬｔから送出された薬剤を注入針１０に向けて流通させる流路を形成している。チューブ６０は、本実施形態において送液ポンプＬｔと内筒２０を接続するように構成している。チューブ６０は、可撓性のある公知のプラスチック材料から構成できる。また、チューブ６０には、送液の流通のオンオフを切り替えるために公知のバルブ等を設置することができる。また、圧力センサ５０は、本実施形態において内筒２０の内部空間２１に設置しているが、圧力センサの設置場所は内筒の内部空間に限定されず、チューブ６０の内部空間のように医療システム１における投与経路のいずれかの場所であってもよい。 The tube 60 forms a flow path through which the drug delivered from the liquid delivery pump Lt is circulated toward the injection needle 10 . The tube 60 is configured to connect the liquid transfer pump Lt and the inner cylinder 20 in this embodiment. Tube 60 may be constructed from any known flexible plastic material. In addition, a known valve or the like can be installed in the tube 60 for switching ON/OFF of the flow of liquid feeding. In addition, the pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20 in this embodiment, but the location of installation of the pressure sensor is not limited to the internal space of the inner cylinder, and is similar to the internal space of the tube 60 . It may be anywhere along the route of administration in system 1 .
　通知部７０は、制御部８０の判断結果を使用者に通知可能に構成している。通知部７０は、制御部８０の判断結果を使用者に通知できれば種々の通知方法を採用できるが、例示すれば、圧力センサ５０の測定値を数値や文字にて表示したり、圧力センサ５０の測定値を時系列にしたがってグラフで表示したり、音声で通知したりできる。 The notification unit 70 is configured to be able to notify the user of the determination result of the control unit 80 . The notification unit 70 can adopt various notification methods as long as it can notify the user of the determination result of the control unit 80. The measured values can be displayed in chronological graphs and notified by voice.
　制御部８０は、圧力センサ５０、送液ポンプＬｔ、通知部７０と接続され、送液ポンプＬｔおよび通知部７０を制御可能に構成している。制御部８０はＣＰＵ（Ｃｅｎｔｒａｌ　Ｐｒｏｃｅｓｓｉｎｇ　Ｕｎｉｔ）、ＧＰＵ（Ｇｒａｐｈｉｃｓ　Ｐｒｏｃｅｓｓｉｎｇ　Ｕｎｉｔ）等のプロセッサ、メモリ等の主記憶、ＨＤＤ（Ｈａｒｄ　Ｄｉｓｃ　Ｄｒｉｖｅ）、ＳＳＤ（Ｓｏｌｉｄ　Ｓｔａｔｅ　Ｄｒｉｖｅ）などの補助記憶等を備える。 The control unit 80 is connected to the pressure sensor 50, the liquid-sending pump Lt, and the notification unit 70, and is configured to be able to control the liquid-sending pump Lt and the notification unit 70. The control unit 80 includes processors such as CPU (Central Processing Unit) and GPU (Graphics Processing Unit), main storage such as memory, auxiliary storage such as HDD (Hard Disc Drive) and SSD (Solid State Drive).
　送液ポンプＬｔは医療システム１に接続され、注入針１０に向けて薬剤を流通させるように構成している。送液ポンプＬｔは、図１に示すようにシリンジＬｔ１と、押し子Ｌｔ２と、モーターＬｔ３と、を備える。シリンジＬｔ１は薬剤を収容する内部空間を設けるとともに、基端側から押し子Ｌｔ２を挿入可能に構成しており、先端側にチューブ６０を接続可能に構成している。シリンジＬｔ１は内筒２０等と同様に構成できる。 The liquid-sending pump Lt is connected to the medical system 1 and configured to circulate the drug toward the injection needle 10 . The liquid-sending pump Lt includes a syringe Lt1, a plunger Lt2, and a motor Lt3, as shown in FIG. The syringe Lt1 is provided with an internal space for containing a drug, and is configured so that a pusher Lt2 can be inserted from the base end side, and a tube 60 can be connected to the tip end side. The syringe Lt1 can be configured similarly to the inner cylinder 20 and the like.
　押し子Ｌｔ２は、シリンジＬｔ１の内部空間に収容された状態で液密に移動（摺動）可能に構成している。これにより、シリンジＬｔ１の内部空間を減少させる方向に移動すれば、チューブ６０および内筒２０を通じて薬剤を注入針１０に向けて送液できる。 The plunger Lt2 is configured to be liquid-tightly movable (slidable) while being housed in the internal space of the syringe Lt1. As a result, when the syringe Lt1 is moved in the direction of decreasing the internal space, the medicine can be delivered toward the injection needle 10 through the tube 60 and the inner cylinder 20 .
　モーターＬｔ３は、押し子Ｌｔ２と接続されてシリンジＬｔ１の内部空間が変化するように押し子Ｌｔ２を移動させる駆動力を生じさせる。送液ポンプＬｔは、本実施形態においてモーターＬｔ３の駆動によって薬剤を注入針１０に向けて流通させる駆動力を生じさせる。モーターＬｔ３は送りねじ等を介して押し子Ｌｔ２と接続されることによって、モーターＬｔ３の回転は押し子Ｌｔ２の並進（直線）方向の移動に変換することができる。モーターＬｔ３は、時計回りおよび反時計回りに回転できるように構成している。 The motor Lt3 is connected to the plunger Lt2 and generates a driving force that moves the plunger Lt2 so that the internal space of the syringe Lt1 changes. The liquid-sending pump Lt generates a driving force for circulating the drug toward the injection needle 10 by driving the motor Lt3 in this embodiment. By connecting the motor Lt3 to the pusher Lt2 via a feed screw or the like, the rotation of the motor Lt3 can be converted into translational (linear) movement of the pusher Lt2. The motor Lt3 is configured to rotate clockwise and counterclockwise.
　（使用例）
　次に医療器具１００を含む医療システム１の使用例について説明する。 (Example of use)
Next, a usage example of the medical system 1 including the medical device 100 will be described.
　まず、術者はチューブ６０を内筒２０と送液ポンプＬｔに接続する。そして、注入針１０を標的組織Ｔに穿刺しない状態で送液ポンプＬｔを作動させ、薬剤をチューブ６０の内部空間、内筒２０の内部空間２１を通じて注入針１０の内部空間に流通させるプライミングの操作を行う。薬剤はあくまで標的組織Ｔへの投与を目的としており、プライミングの際に注入針１０の先端部から流出し得る薬剤の取り扱いには十分に留意する。 First, the operator connects the tube 60 to the inner cylinder 20 and the liquid transfer pump Lt. Then, in a state where the injection needle 10 is not punctured into the target tissue T, the liquid feeding pump Lt is operated, and a priming operation is performed to circulate the drug into the internal space of the injection needle 10 through the internal space of the tube 60 and the internal space 21 of the inner cylinder 20. I do. The purpose of the drug is to administer it to the target tissue T, and sufficient attention should be paid to the handling of the drug that may flow out from the tip of the injection needle 10 during priming.
　プライミングを終えたら、術者は注入針１０の先端部をカニューレ３０の内部空間に収容する。注入針１０の先端部をカニューレ３０の内部空間に収容した状態で医療器具１００を移動させることによって、移動の際に薬剤が意図せず漏出することを防止または抑制できる。 After priming, the operator puts the tip of the injection needle 10 into the internal space of the cannula 30 . By moving the medical device 100 with the distal end of the injection needle 10 housed in the internal space of the cannula 30, unintentional leakage of the drug during movement can be prevented or suppressed.
　次に、術者は患者の腹部のあたりに小切開部を形成して、超音波エコー下で体表から経皮的にカニューレ３０の穿刺を行い、注入針１０の先端部を腫瘍部位等の標的組織Ｔの近傍まで移動させる。次に、術者は注入針１０の先端部をカニューレ３０から外部に露出させて注入針１０の先端部を標的組織Ｔに穿刺して、薬剤を標的組織Ｔに投与する。薬剤の投与が終了したら、術者は注入針１０の先端部をカニューレ３０の内部に収容して注入針１０及びカニューレ３０を体内から抜去する。 Next, the operator makes a small incision around the patient's abdomen, percutaneously punctures the cannula 30 from the body surface under ultrasonic echo, and inserts the tip of the injection needle 10 into the tumor site or the like. Move to the vicinity of the target tissue T. Next, the operator exposes the tip of the injection needle 10 from the cannula 30 to the outside and pierces the target tissue T with the tip of the injection needle 10 to administer the drug to the target tissue T. FIG. After the administration of the drug is finished, the operator puts the tip of the injection needle 10 inside the cannula 30 and removes the injection needle 10 and the cannula 30 from the body.
　本実施形態において実施する抗がん剤等の薬剤を用いた治療では、副作用の強い薬剤や、デリバリー性が少ない薬剤に対して全身性の副作用を抑えながら腫瘍内の薬剤集積量を高めることが可能な投与方法が求められている。これに対して、本実施形態に係る医療システム１の注入針１０のように標的組織Ｔに薬剤を直接投与することによって、薬剤の集積量を増加させ、薬効の増加を図ることができる。また、医療システム１のように血管内に薬剤を投与しないことで全身への暴露（副作用）を低減させることができる。 In the treatment using drugs such as anticancer drugs performed in this embodiment, it is possible to increase the amount of drug accumulation in the tumor while suppressing systemic side effects for drugs with strong side effects and drugs with low delivery properties. A possible administration method is sought. On the other hand, by directly administering the drug to the target tissue T like the injection needle 10 of the medical system 1 according to this embodiment, it is possible to increase the accumulated amount of the drug and increase the efficacy of the drug. In addition, unlike the medical system 1, the systemic exposure (side effects) can be reduced by not administering the drug into blood vessels.
　以上説明したように医療器具１００は、長尺の筒状に形成され内部に薬剤が流通する流路を形成する内壁面１１と、内壁面１１と反対側に形成され、外部に臨む外壁面１２とを備え、長手方向Ｘにおける先端部が閉じている注入針１０を有する。外壁面１２と内壁面１１とは、流路と連通する複数の穴部１３によって接続される。外壁面１２は、溝部１４を形成するように凹凸状に形成される。溝部１４は、複数の穴部１３において隣接する穴部１３を長手方向Ｘにつなげるように設けられる。 As described above, the medical device 100 includes an inner wall surface 11 which is formed in a long cylindrical shape and forms a flow path for the medicine to flow therein, and an outer wall surface 12 which is formed on the opposite side of the inner wall surface 11 and faces the outside. and has an injection needle 10 with a closed distal end in the longitudinal direction X. The outer wall surface 12 and the inner wall surface 11 are connected by a plurality of holes 13 communicating with the flow path. The outer wall surface 12 is formed in an uneven shape so as to form a groove portion 14 . The groove portion 14 is provided so as to connect adjacent hole portions 13 in the longitudinal direction X in the plurality of hole portions 13 .
　図５～図７は比較例に係る溝部のない注入針ＤＬの先端部の穴部Ｓｐから薬剤Ｍｄが流出する様子を示す図であり、図８～図１０は本実施形態に係る注入針１０の先端部の穴部１３から薬剤が流出する様子を示す図である。図１１は図５に示す比較例に係る注入針ＤＬと標的組織Ｔとの接触について示す断面図、図１２は本実施形態に係る注入針１０において注入針１０と標的組織Ｔとの接触について示す断面図である。 5 to 7 are views showing how the drug Md flows out from the hole Sp at the tip of the injection needle DL having no groove according to the comparative example, and FIGS. 8 to 10 are the injection needle 10 according to the present embodiment. FIG. 10 is a diagram showing how the medicine flows out from the hole 13 at the tip of the . 11 is a cross-sectional view showing contact between the injection needle DL and the target tissue T according to the comparative example shown in FIG. 5, and FIG. 12 shows contact between the injection needle 10 and the target tissue T in the injection needle 10 according to this embodiment. It is a sectional view.
　浸透しにくい腫瘍や、密な腫瘍、繊維質が多い腫瘍に対する薬剤投与の場合のように、生体組織内での薬剤Ｍｄの浸透にはある程度限界がある。特に比較例のような注入針ＤＬでは穴部Ｓｐから薬剤Ｍｄが別々に流出する程度で薬剤Ｍｄが十分に広がらない可能性がある。また、穴部Ｓｐから流出する薬剤Ｍｄの量も図７に示すように偏りが生じやすい。このように比較例に係る注入針ＤＬは薬剤を流出する部分の面積が比較的小さく、流出する薬剤Ｍｄの量に偏りも生じやすいことから、穴部Ｓｐから薬剤Ｍｄを腫瘍内に十分な量投与できず、その結果、薬効が比較的低くなってしまう恐れがある。 There is a certain limit to the penetration of drug Md into living tissue, such as in the case of drug administration to tumors that are difficult to penetrate, dense tumors, and fibrous tumors. In particular, in the injection needle DL of the comparative example, the medicine Md may flow out separately from the hole Sp and the medicine Md may not spread sufficiently. Also, the amount of the medicine Md flowing out from the hole Sp is likely to be uneven as shown in FIG. As described above, the injection needle DL according to the comparative example has a relatively small area from which the drug flows out, and the amount of the drug Md that flows out is likely to be uneven. It may not be possible to administer, resulting in relatively low drug efficacy.
　これに対して、本実施形態に係る医療器具１００は上記のように注入針１０に溝部１４を設けることによって、図１２に示すように注入針１０の外表面において標的組織Ｔと注入針１０の外表面において薬剤Ｍｄが流通しうる液面の面積を広くとることができる。これにより、溝部１４を注入針１０の外表面に広く流通させて薬剤Ｍｄを組織内で広範囲に拡散させることができる。また、腫瘍内で部分的に薬剤Ｍｄの浸透しにくい部位があっても、薬剤Ｍｄは溝部１４を伝わることで薬剤Ｍｄの比較的浸透しやすい部位に流れ得る。 In contrast, in the medical device 100 according to the present embodiment, by providing the injection needle 10 with the groove portion 14 as described above, the target tissue T and the injection needle 10 are separated from each other on the outer surface of the injection needle 10 as shown in FIG. It is possible to secure a large liquid surface area through which the medicine Md can flow on the outer surface. As a result, the groove portion 14 can be widely circulated on the outer surface of the injection needle 10, and the drug Md can be widely diffused within the tissue. Further, even if there is a part of the tumor where it is difficult for the drug Md to permeate, the drug Md can flow through the groove 14 to a site where the drug Md can relatively easily permeate.
　また、薬剤Ｍｄは溝部１４を伝わることによって、穴部１３から流出する薬剤Ｍｄの量を図１０に示すように均一にするか、均一に近づけることができる。これにより、薬剤Ｍｄの投与によってより広範囲に薬剤Ｍｄを作用させて薬効を向上させることができる。また、溝部１４は凹形状のように形成することによって超音波のエコープローブから照射される超音波を反射しやすくできる。これにより、超音波エコー画像での穿刺手技において針穴が複数存在する範囲を腫瘍内部に位置させることを容易にし、注入針１０の視認性を向上させることができる。 In addition, the amount of the medicine Md flowing out from the hole 13 can be made uniform as shown in FIG. This allows the drug Md to act in a wider range by administering the drug Md, thereby improving the efficacy. Further, by forming the groove portion 14 in a concave shape, it is possible to easily reflect the ultrasonic waves emitted from the ultrasonic echo probe. This makes it easy to position the range where a plurality of needle holes exist inside the tumor in the puncture procedure using the ultrasonic echo image, and the visibility of the injection needle 10 can be improved.
　（変形例１）
　図１３は変形例１に係る医療器具の注入針１０ａを示す側面図である。第１実施形態において穴部１３は側面視した際の形状が略円形であると説明した。ただし、注入針の内部空間である流路に流通する薬剤Ｍｄを外部に放出できれば、穴部の具体的な形状は円形に限定されない。上記以外にも穴部１３ａは、図１３に示すように長手方向Ｘと交差する側方から見た際にひし形等のような多角形に構成できる。穴部を構成する多角形はひし形以外にも三角形、ひし形以外の四角形、六角形などのその他の多角形であってもよい。このように構成することによって、注入針１０の先端部の強度を向上させ得る。 (Modification 1)
FIG. 13 is a side view showing an injection needle 10a of a medical device according to Modification 1. FIG. In the first embodiment, it has been described that the hole 13 has a substantially circular shape when viewed from the side. However, the specific shape of the hole is not limited to a circle, as long as the drug Md flowing through the flow path, which is the internal space of the injection needle, can be released to the outside. In addition to the above, the hole portion 13a can be formed in a polygonal shape such as a rhombus when viewed from the side crossing the longitudinal direction X as shown in FIG. Polygons forming the holes may be other polygons than rhombuses, such as triangles, quadrilaterals other than rhombuses, and hexagons. By configuring in this way, the strength of the tip portion of the injection needle 10 can be improved.
　なお、穴部１３ａ以外の医療器具のその他の構成は第１実施形態と同様であり、使用例についても第１実施形態と同様であるため、説明を省略する。後述する変形例２以降においても使用例は第１実施形態と同様であり、第１実施形態と異なる構成について説明し、共通する構成及び使用例については説明を省略する。 The configuration of the medical instrument other than the hole portion 13a is the same as that of the first embodiment, and the usage example is also the same as that of the first embodiment, so the description is omitted. The usage examples of Modified Example 2 and later described later are the same as those of the first embodiment, and the configurations different from the first embodiment will be described, and the descriptions of the common configurations and usage examples will be omitted.
　（変形例２～変形例５）
　図１４から図１７は変形例２から変形例５に係る医療器具の注入針１０ｂの溝部１４ｂ～注入針１０ｅの溝部１４ｅを溝部の延びる方向から見た図である。第１実施形態において溝部１４は溝部の延びる長手方向Ｘから見た形状が略円弧形状であると説明した。 (Modification 2 to Modification 5)
FIGS. 14 to 17 are diagrams of the groove 14b of the injection needle 10b to the groove 14e of the injection needle 10e of the medical devices according to Modifications 2 to 5 as viewed from the extending direction of the grooves. In the first embodiment, it has been described that the shape of the groove 14 when viewed from the longitudinal direction X in which the groove extends is substantially arcuate.
　ただし、溝部の具体的な形状は略円弧形状に限定されない。溝部は、薬剤Ｍｄが配置される際の薬剤Ｍｄが注入針の長手方向Ｘと交差する径方向Ｙにおける内側に向かって流通することを促進する誘引部を備えるように構成してもよい。具体的に言えば、溝部は溝部の延びる方向から見た際に、溝部の断面形状における隅のなす角度を９０度以下に構成してもよい。 However, the specific shape of the groove is not limited to a substantially arc shape. The groove portion may be configured to include a guide portion that promotes the medicine Md to flow inward in the radial direction Y that intersects the longitudinal direction X of the injection needle when the medicine Md is placed. Specifically, when viewed from the direction in which the groove extends, the angle formed by the corners of the cross-sectional shape of the groove may be 90 degrees or less.
　より具体的に言えば、図１４に示すように溝部の延びる方向から見た注入針１０ｂの溝部１４ｂの形状は、略円形を矩形で切り欠くように形成してもよい（変形例２）。 More specifically, as shown in FIG. 14, the shape of the groove 14b of the injection needle 10b when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a rectangle (Modification 2).
　また、上記以外にも図１５に示すように溝部の延びる方向から見た注入針１０ｃの溝部１４ｃの形状は、略円形を三角形のような形状で切り欠くように形成してもよい（変形例３）。 In addition to the above, as shown in FIG. 15, the shape of the groove 14c of the injection needle 10c when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a triangular shape (modification example 3).
　上記以外にも図１６に示すように溝部の延びる方向から見た注入針１０ｄの溝部１４ｄの形状は、略円形を段付きの多角形で切り欠くように形成してもよい（変形例４）。 In addition to the above, as shown in FIG. 16, the shape of the groove 14d of the injection needle 10d when viewed from the direction in which the groove extends may be formed by cutting a substantially circular shape into a stepped polygon (Modification 4). .
　さらに、図１７に示すように、溝部の延びる方向から見た注入針１０ｅの溝部１４ｅの形状は、幅寸法（図１７の横方向に対応する寸法）が径方向外方に向かうほど小さくなる多角形にて切り欠いた形状に形成してもよい（変形例５）。 Furthermore, as shown in FIG. 17, the shape of the groove 14e of the injection needle 10e when viewed from the direction in which the groove extends tends to decrease as the width dimension (the dimension corresponding to the lateral direction in FIG. 17) goes radially outward. You may form in the shape notched by the square (Modification 5).
　このように変形例２の溝部１４ｂ～変形例５の溝部１４ｅは薬剤が配置される際の液面が注入針１０の長手方向Ｘと交差する径方向Ｙにおける内方に向かって凹むことを促進する誘引部を備える。誘引部は、溝部１４ｂ～溝部１４ｅのように溝部の延びる方向から溝部を見た際に溝部の断面形状における隅部のなす角度が９０度以下になるように構成している。このように構成することによって、図１４～図１７に示すように溝部の内部に標的組織Ｔが侵入して溝部を完全に閉塞することを防止でき、腫瘍などの標的組織Ｔ内において薬剤Ｍｄを注入針の外表面において拡散しやすくし得る。 In this manner, the groove portion 14b of Modification Example 2 to the groove portion 14e of Modification Example 5 promote the inward depression of the liquid surface in the radial direction Y intersecting the longitudinal direction X of the injection needle 10 when the drug is placed. It is equipped with an attracting part. The guiding portion is configured such that the angle formed by the corners of the cross-sectional shape of the groove is 90 degrees or less when the groove is viewed from the direction in which the groove extends, such as the grooves 14b to 14e. With this configuration, as shown in FIGS. 14 to 17, it is possible to prevent the target tissue T from entering the groove and completely blocking the groove. It may facilitate diffusion on the outer surface of the injection needle.
　（変形例６）
　図１８は変形例６に係る医療器具の注入針１０ｆの先端部を示す側面図である。第１実施形態では注入針１０の溝部１４が長手方向Ｘに沿って形成されると説明したが、溝部の具体的な態様は上記に限定されない。溝部１４ｆは上記以外にも図１８に示すように注入針の外表面においてらせん状に延在して形成するように構成してもよい。すなわち、本明細書において溝部が隣接する穴部を「長手方向」につなげるとは、隣接する穴部同士の位置が周方向に変位しておらず、かつ長手方向Ｘに変位している穴部同士をつなげる場合だけを意図しない。上記記載は図１８等に示すように隣接する穴部が長手方向Ｘだけでなく周方向に変位している穴部同士をつなげる場合をも含む。 (Modification 6)
FIG. 18 is a side view showing the tip of an injection needle 10f of a medical device according to Modification 6. FIG. Although the groove 14 of the injection needle 10 is formed along the longitudinal direction X in the first embodiment, the specific aspect of the groove is not limited to the above. In addition to the above, the groove portion 14f may be configured to extend spirally on the outer surface of the injection needle as shown in FIG. That is, in this specification, connecting adjacent holes with grooves in the "longitudinal direction" means that the positions of the adjacent holes are not displaced in the circumferential direction and are displaced in the longitudinal direction X. It is not intended only for connecting with each other. The above description also includes the case where adjacent hole portions are displaced not only in the longitudinal direction X but also in the circumferential direction, as shown in FIG. 18 and the like.
　このように溝部１４ｆをらせん状に延在するように構成することによって、溝部１４のように溝部が長手方向Ｘに延在する場合と比較して超音波をより反射しやすくし得る。 By configuring the groove portion 14f to extend spirally in this way, it is possible to make it easier to reflect ultrasonic waves compared to the case where the groove portion extends in the longitudinal direction X like the groove portion 14.
　（変形例７）
　図１９は変形例７に係る医療器具の注入針１０ｇを示す側面図である。第１実施形態において溝部１４は長手方向Ｘに沿って延在するように設けていると説明したが、溝部の具体的な態様は長手方向Ｘに沿って溝部１４のみを設ける場合に限定されない。 (Modification 7)
FIG. 19 is a side view showing an injection needle 10g of a medical device according to Modification 7. FIG. In the first embodiment, the groove portion 14 is provided so as to extend along the longitudinal direction X, but the specific aspect of the groove portion is not limited to the case where only the groove portion 14 is provided along the longitudinal direction X.
　上記以外にも注入針１０ｇは、図１９に示すように穴部１３を長手方向Ｘ及び周方向に並んで配置している際に、第１実施形態と同様の長手方向Ｘに延びる溝部１４と、周方向に隣接して並ぶ穴部１３の間に溝部１４ｇと、を備えるように構成してもよい。 In addition to the above, the injection needle 10g has grooves 14 extending in the longitudinal direction X as in the first embodiment when the holes 13 are arranged side by side in the longitudinal direction X and the circumferential direction as shown in FIG. , and a groove portion 14g between the hole portions 13 adjacent to each other in the circumferential direction.
　このように構成することによって、組織内における薬剤Ｍｄの拡散性をより向上させ得るとともに、超音波エコー画像下における注入針１０ｇの視認性を向上させ得る。注入針１０ｇの溝部１４ｇは周方向に延在するように構成することによって、長手方向Ｘに沿う溝部１４に比べて超音波をより反射しやすくし得る。 With this configuration, the diffusibility of the drug Md in the tissue can be further improved, and the visibility of the injection needle 10g under the ultrasonic echo image can be improved. Grooves 14g of the injection needle 10g are configured to extend in the circumferential direction, so that ultrasonic waves can be reflected more easily than grooves 14 extending along the longitudinal direction X. As shown in FIG.
　（変形例８～変形例１０）
　図２０から図２３は変形例８に係る医療器具の注入針１０ｈの溝部１４ｈ～変形例１０に係る注入針１０ｍの溝部１４ｍについて示す図である。第１実施形態では溝部１４が複数の穴部１３において長手方向Ｘにおける先端部および基端部の穴部まで設けると説明した。 (Modification 8 to Modification 10)
20 to 23 are diagrams showing the groove 14h of the injection needle 10h of the medical device according to the eighth modification to the groove 14m of the injection needle 10m according to the tenth modification. In the first embodiment, it has been described that the grooves 14 are provided up to the holes at the distal end and the proximal end in the longitudinal direction X in the plurality of holes 13 .
　ただし、注入針の外表面において薬剤Ｍｄが拡散し得る部位が設けられていれば、注入針１０ｈの溝部１４ｈは図２０、図２１に示すように溝部の延びる方向において最も先端側または基端側の穴部を超えた位置まで設けるように構成してもよい（変形例８）。溝部１４ｈは、図２０および図２１に示すように隣接する穴部１３をつなぐ第１部位Ｐｒ１を通じて、穴部１３を超えた第２部位Ｐｒ２まで形成するように構成している。 However, if a portion where the drug Md can diffuse is provided on the outer surface of the injection needle, the groove portion 14h of the injection needle 10h is located on the most distal side or the proximal side in the extending direction of the groove portion as shown in FIGS. (Modification 8). The groove portion 14h is configured to extend to a second portion Pr2 beyond the hole portion 13 through the first portion Pr1 connecting the adjacent hole portions 13 as shown in FIGS. 20 and 21 .
　また、溝部１４ｈは、図２０に示すように先端側の端部の位置が注入針の先端から離間した位置まで延在するように構成している。ただし、上記以外にも注入針１０ｋの溝部１４ｋは、図２２に示すように第２部位Ｐｒ２の先端位置が注入針の先端（刃面）に達する程度に延在するように形成してもよい（変形例９）。 In addition, as shown in FIG. 20, the groove portion 14h is configured such that the position of the end on the distal end side extends to a position separated from the distal end of the injection needle. However, in addition to the above, the groove portion 14k of the injection needle 10k may be formed so as to extend to such an extent that the tip position of the second portion Pr2 reaches the tip (blade surface) of the injection needle as shown in FIG. (Modification 9).
　さらに溝の端部が穴部１３を超えて位置する形態は溝部の延びる方向が純粋に長手方向Ｘに沿う場合だけに限定されず、上記以外にも注入針１０ｍの溝部１４ｍに示すように溝部がらせん状に延びるような場合に適用することができる（変形例１０）。 Furthermore, the form in which the end of the groove is positioned beyond the hole 13 is not limited to the case where the direction in which the groove extends is purely along the longitudinal direction X. It can be applied to the case where a spiral extends (Modification 10).
　このように、溝部１４ｈ、１４ｋ、１４ｍは隣接する穴部をつなぐ第１部位Ｐｒ１を通じ、穴部を超えた第２部位Ｐｒ２まで形成するように構成している。このように構成することによって薬剤の拡散性をさらに向上させることができる。 In this way, the grooves 14h, 14k, and 14m are configured to pass through the first portion Pr1 connecting the adjacent holes and extend to the second portion Pr2 beyond the holes. Such a configuration can further improve the diffusibility of the drug.
　（変形例１１、変形例１２）
　図２４、図２５は変形例１１、変形例１２に係る医療器具の溝部について示す側面図である。第１実施形態では溝部１４が隣接する穴部１３をつなぐように形成すると説明した。ただし、溝部は穴部１３を通る溝部１４に加えて穴部１３から離間するとともに、溝部１４に隣接して形成される溝部（第２溝部に相当）を備えるように構成してもよい。 (Modification 11, Modification 12)
24 and 25 are side views showing grooves of medical instruments according to modified examples 11 and 12. FIG. In the first embodiment, it has been described that the grooves 14 are formed so as to connect the adjacent holes 13 . However, in addition to the groove portion 14 passing through the hole portion 13 , the groove portion may be configured to include a groove portion (corresponding to a second groove portion) formed adjacent to the groove portion 14 while being separated from the hole portion 13 .
　第２溝部の具体的な態様は図２４に示す注入針１０ｎの溝部１５のように第２溝部が長手方向Ｘに延在する場合（変形例１１）に限定されず、図２５に示す注入針１０ｐの溝部１５ｐのように第２溝部が周方向に延びる場合（変形例１２）なども含みうる。図２５において溝部１５ｐは溝部１４と交差するように形成している。 A specific aspect of the second groove portion is not limited to the case where the second groove portion extends in the longitudinal direction X like the groove portion 15 of the injection needle 10n shown in FIG. A case where the second groove portion extends in the circumferential direction like the groove portion 15p of 10p (Modification 12) can also be included. In FIG. 25, the groove portion 15p is formed so as to intersect with the groove portion 14. As shown in FIG.
　このように、注入針に溝部１４等に加えて溝部１５、および溝部１５ｐのように穴部１３から離間するとともに、溝部１４に隣接して形成される第２溝部を設けることによって、薬剤の拡散性を向上させ得る。また、超音波エコー画像下における注入針の視認性を向上させることができる。 In this way, in addition to the grooves 14 and the like, the injection needle is provided with grooves 15 and grooves 15p, which are separated from the hole 13 and are formed adjacent to the grooves 14, so that the drug is diffused. can improve sexuality. Also, the visibility of the injection needle under the ultrasonic echo image can be improved.
　（変形例１３）
　図２６は変形例１３に係る医療器具の注入針１０ｑについて示す側面図である。第１実施形態では溝部１４の寸法が穴部１３の（径）寸法と同程度であると説明した。ただし、溝部の仕様はこれに限定されず、上記以外にも溝部１４ｑは穴部１３の幅寸法以上に大きく構成してもよい。 (Modification 13)
FIG. 26 is a side view showing an injection needle 10q of a medical device according to modification 13. FIG. In the first embodiment, it was explained that the dimension of the groove portion 14 is approximately the same as the (diameter) dimension of the hole portion 13 . However, the specification of the groove portion is not limited to this, and the groove portion 14q may be configured to be larger than the width dimension of the hole portion 13 other than the above.
　このように溝部１４ｑを穴部１３の幅以上に大きく確保することによって穴部１３から放出される薬剤Ｍｄの標的組織Ｔとの接触面積を大きくして、薬剤の拡散性を向上させるとともに、超音波エコー画像での視認性（造影性）を向上させることができる。 By ensuring that the groove portion 14q is larger than the width of the hole portion 13 in this manner, the contact area of the drug Md released from the hole portion 13 with the target tissue T is increased, thereby improving the diffusibility of the drug, It is possible to improve the visibility (contrastability) in the acoustic echo image.
　（変形例１４）
　図２７は変形例１４に係る医療器具の注入針１０ｒについて示す側面図である。第１実施形態では溝部１４が長手方向Ｘに並ぶ一群の穴部１３に対して一列形成すると説明した。ただし、溝部の具体的な構成は一群の穴部１３に一列の溝部を設ける場合に限定されない。 (Modification 14)
FIG. 27 is a side view showing an injection needle 10r of a medical device according to modification 14. FIG. In the first embodiment, it has been described that the grooves 14 are formed in a line with respect to the group of holes 13 arranged in the longitudinal direction X. As shown in FIG. However, the specific configuration of the grooves is not limited to the case where a row of grooves is provided in the group of holes 13 .
　溝部は、図２７の溝部１４ｒ１、１４ｒ２のように一つの穴部１３よりも幅を小さく形成し、かつ一の穴部１３に複数の溝部１４ｒ１、１４ｒ２が通るように構成してもよい。このように溝部１４ｒ１、１４ｒ２を穴部１３の幅よりも小さく形成し、一の穴部１３を複数の溝部１４ｒ１、１４ｒ２が通るように形成することによって薬剤Ｍｄの拡散性を向上させることができる。また、超音波エコー画像下における注入針の視認性（造影性）を向上させることができる。 The grooves may be formed to have a width smaller than that of one hole 13 like the grooves 14r1 and 14r2 in FIG. By forming the groove portions 14r1 and 14r2 smaller than the width of the hole portion 13 in this way and forming one hole portion 13 so that the plurality of groove portions 14r1 and 14r2 pass through, the diffusibility of the medicine Md can be improved. . In addition, the visibility (contrastability) of the injection needle under the ultrasonic echo image can be improved.
　（変形例１５～変形例１７）
　図２８、図２９は変形例１５に係る医療器具の注入針１０ｓについて示す側面図及び断面図、図３０、図３１は変形例１６に係る医療器具の注入針１０ｔについて示す側面図及び断面図である。図３２、図３３は変形例１７に係る医療器具の注入針１０ｕについて示す側面図及び断面図である。 (Modification 15 to Modification 17)
28 and 29 are a side view and a sectional view showing an injection needle 10s of a medical device according to Modification 15, and FIGS. 30 and 31 are a side view and a sectional view showing an injection needle 10t of a medical device according to Modification 16. be. 32 and 33 are a side view and a cross-sectional view showing an injection needle 10u of a medical device according to modification 17. FIG.
　第１実施形態では腫瘍などの標的組織Ｔ内での薬剤Ｍｄの拡散を向上させるために注入針１０に溝部１４を設けると説明した。ただし、注入針には穴部１３及び溝部１４等に加えて穴部１３から放出される薬剤Ｍｄの外壁面１２の基端側への流通を阻害するストッパーを設けるように構成してもよい。 In the first embodiment, it was explained that the injection needle 10 is provided with the groove 14 in order to improve the diffusion of the drug Md within the target tissue T such as a tumor. However, in addition to the holes 13 and the grooves 14 , the injection needle may be provided with a stopper that prevents the drug Md released from the holes 13 from flowing to the proximal side of the outer wall surface 12 .
　ストッパーの具体的な態様について説明すれば、図２８、図２９に示すように穴部１３の中でも最も基端側の穴部１３よりも基端側にストッパー１６に相当する凸形状を隣接して設けることができる（変形例１５）。ストッパー１６の凸形状は溝部１４の周囲の面１２ａから径方向外方に突出して設けている。 As shown in FIGS. 28 and 29, a convex shape corresponding to the stopper 16 is formed adjacent to the proximal side of the hole 13 which is the most proximal side among the holes 13 . can be provided (Modification 15). The convex shape of the stopper 16 protrudes radially outward from the surface 12 a surrounding the groove portion 14 .
　ストッパーを図２８、図２９のような凸形状によって構成する場合、ストッパー１６の凸形状の幅は図２８等のように穴部１３の径寸法以下に構成する場合に限定されない。上記以外にも図３０、図３１のストッパー１６ｔのように凸形状の幅を穴部１３の径寸法より大きく構成してもよい（変形例１６）。 When the stopper is configured in a convex shape as shown in FIGS. 28 and 29, the width of the convex shape of the stopper 16 is not limited to the case where it is configured to be equal to or less than the diameter of the hole portion 13 as shown in FIG. 28 and the like. In addition to the above, the width of the convex shape may be made larger than the diameter dimension of the hole portion 13 like the stopper 16t in FIGS. 30 and 31 (Modification 16).
　また、ストッパーの形状は、図３２、図３３のストッパー１６ｕのように注入針１０ｕの溝部１４の周囲の面１２ａより径方向内方に凹むように形成してもよい（変形例１７）。このように変形例１５～変形例１７に係る注入針１０ｓ、１０ｔ、１０ｕにストッパー１６、１６ｔ、１６ｕを設けることによって、穿刺部位からの薬剤漏れを防止し、腫瘍内等の標的組織Ｔにおける薬剤Ｍｄの拡散を促進することができる。 Also, the shape of the stopper may be formed so as to be recessed radially inward from the surface 12a surrounding the groove 14 of the injection needle 10u, like the stopper 16u in FIGS. 32 and 33 (Modification 17). By providing the stoppers 16, 16t, and 16u on the injection needles 10s, 10t, and 10u according to Modifications 15 to 17, leakage of the drug from the puncture site is prevented, and the drug in the target tissue T such as a tumor is prevented. Diffusion of Md can be promoted.
　なお、本発明は上述した実施形態にのみ限定されず、特許請求の範囲において種々の変更が可能である。図３４は変形例１８に係る注入針１０ｖの先端部を示す側面図であり、図３５は変形例１９に係る注入針１０ｗの先端部を示す側面図である。 It should be noted that the present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. 34 is a side view showing the tip of an injection needle 10v according to Modification 18, and FIG. 35 is a side view showing the tip of an injection needle 10w according to Modification 19. As shown in FIG.
　第１実施形態では穴部１３が長手方向Ｘまたは周方向において隣接する穴部と揃うように配置されると説明した。ここで長手方向Ｘに並ぶ穴部のまとまりを第１グループとした場合、注入針１０ｖの第１グループ１３Ｒ１の穴部と第１グループ１３Ｒ２の穴部は図３４に示すように長手方向Ｘにおける位置をずらすように構成してもよい（変形例１８）。 In the first embodiment, it was explained that the holes 13 are arranged so as to be aligned with adjacent holes in the longitudinal direction X or the circumferential direction. Here, when a group of holes arranged in the longitudinal direction X is defined as a first group, the holes in the first group 13R1 and the holes in the first group 13R2 of the injection needle 10v are positioned in the longitudinal direction X as shown in FIG. may be shifted (modification 18).
　また、周方向に並ぶ穴部のまとまりを第２グループとした場合、注入針１０ｗの第２グループ１３Ｃ１の穴部と第２グループ１３Ｃ２の穴部は、図３５に示すように周方向における位置をずらすように構成してもよい（変形例１９）。なお、図３５において注入針１０ｗの溝部１４ｗは、隣接する穴部をつなぐように、長手方向Ｘだけでなく周方向にも変位するように形成している。 In addition, when the group of holes arranged in the circumferential direction is the second group, the holes in the second group 13C1 and the holes in the second group 13C2 of the injection needle 10w are positioned in the circumferential direction as shown in FIG. You may comprise so that it may be shifted (modification 19). In addition, in FIG. 35, the groove portion 14w of the injection needle 10w is formed so as to be displaced not only in the longitudinal direction X but also in the circumferential direction so as to connect adjacent holes.
　また、第１実施形態において複数の溝部は溝部同士の深さを同一に形成していると説明した。ただし、複数の溝部は互いの溝部の深さを異ならせるように構成してもよい。このように構成することによって、比較的深さが深い溝部を針穴間の薬剤の通路として主に機能させ、比較的深さの浅い溝部を標的組織Ｔと当接する際の表面積を向上させるために主に機能させることができる。 Also, in the first embodiment, it has been described that the plurality of grooves are formed to have the same depth. However, the plurality of grooves may be configured such that the depths of the grooves are different from each other. With this configuration, the relatively deep groove mainly functions as a passage for the drug between the needle holes, and the relatively shallow groove increases the surface area when the target tissue T abuts. can be made to function mainly in
　本出願は、２０２１年１２月１７日に出願された日本国特許出願第２０２１－２０４９８７号に基づいており、その開示内容は参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2021-204987 filed on December 17, 2021, the disclosure of which is incorporated by reference in its entirety.
１　医療システム、
１０、１０ａ、１０ｂ、１０ｃ、１０ｄ、１０ｅ、１０ｆ、１０ｇ、１０ｈ、１０ｋ、１０ｍ、１０ｎ、１０ｐ、１０ｑ、１０ｒ、１０ｓ、１０ｔ、１０ｕ、１０ｖ、１０ｗ　注入針（医療器具）、
１１　内壁面、
１２　外壁面、
１２ａ　面（外壁面の中でも溝部の周囲の面）、
１３　穴部、
１４、１４ｂ、１４ｃ、１４ｄ、１４ｅ、１４ｆ、１４ｇ、１４ｈ、１４ｋ、１４ｍ、１４ｑ、１４ｒ１、１４ｒ２、１４ｗ　溝部、
１４ｂ～１４ｅ　溝部（誘引部を備える溝部）、
１５、１５ｐ　溝部（第２溝部）、
１６、１６ｕ、１６ｔ　ストッパー、
２０　内筒（医療器具）、
４０　外筒（医療器具）、
１００　医療器具、
Ｐｒ１　第１部位、
Ｐｒ２　第２部位、
Ｘ　長手方向。 1 medical system,
10, 10a, 10b, 10c, 10d, 10e, 10f, 10g, 10h, 10k, 10m, 10n, 10p, 10q, 10r, 10s, 10t, 10u, 10v, 10w injection needle (medical device),
11 inner wall surface,
12 outer wall surface,
12a surface (surface around the groove part among the outer wall surfaces),
13 holes,
14, 14b, 14c, 14d, 14e, 14f, 14g, 14h, 14k, 14m, 14q, 14r1, 14r2, 14w grooves,
14b to 14e grooves (grooves provided with induction parts),
15, 15p groove (second groove),
16, 16u, 16t stoppers,
20 inner cylinder (medical device),
40 outer cylinder (medical device),
100 medical instruments,
Pr1 first part,
Pr2 second part,
X longitudinal direction.

Claims (11)

  1. 　長尺の筒状に形成され内部に薬剤が流通する流路を形成する内壁面と、前記内壁面と反対側に形成され、外部に臨む外壁面とを備え、長手方向における先端部が閉じている注入針を有し、
    　前記外壁面と前記内壁面とは、前記流路と連通する複数の穴部によって接続され、
    　前記外壁面は溝部を形成するように凹凸状に形成され、
    　前記溝部は、複数の前記穴部において隣接する前記穴部を前記長手方向につなげるように設けられる医療器具。     It has an inner wall surface formed in a long cylindrical shape and forming a flow path for the medicine therein, and an outer wall surface formed on the opposite side of the inner wall surface and facing the outside, and the tip part in the longitudinal direction is closed. having an infusion needle that is
    The outer wall surface and the inner wall surface are connected by a plurality of holes communicating with the flow path,
    The outer wall surface is formed in an uneven shape so as to form a groove,
    The medical device, wherein the groove is provided so as to connect adjacent holes in the plurality of holes in the longitudinal direction.
  2. 　前記溝部は、前記溝部に薬剤が流通する際の薬剤が前記注入針の前記長手方向と交差する径方向における内側に向かって流通することを促進する誘引部を備える請求項１に記載の医療器具。 2. The medical instrument according to claim 1, wherein the groove includes a guide portion that promotes the medicine to flow inward in a radial direction that intersects with the longitudinal direction of the injection needle when the medicine flows through the groove. .
  3. 　前記誘引部は、前記溝部の延びる方向から前記溝部を見た際に、前記溝部の断面形状における隅のなす角度が９０度以下である請求項２に記載の医療器具。 3. The medical device according to claim 2, wherein the guiding part has an angle formed by corners of the cross-sectional shape of the groove of 90 degrees or less when the groove is viewed from the direction in which the groove extends.
  4. 　前記溝部は、隣接する前記穴部をつなぐ第１部位を通じ、前記穴部を超えた第２部位まで形成される請求項１に記載の医療器具。 The medical device according to claim 1, wherein the groove is formed through a first portion connecting the adjacent holes to a second portion beyond the hole.
  5. 　前記穴部は、前記注入針の前記長手方向に並んで形成されるとともに、前記長手方向と交差する前記注入針の周方向に並んで形成され、
    　前記溝部は、前記長手方向に加えて前記周方向において隣接する前記穴部の間に形成される請求項１に記載の医療器具。     The holes are formed side by side in the longitudinal direction of the injection needle and are formed side by side in the circumferential direction of the injection needle intersecting the longitudinal direction,
    2. The medical device of claim 1, wherein the grooves are formed between adjacent holes in the circumferential direction as well as in the longitudinal direction.
  6. 　前記穴部から離間するとともに、前記溝部に隣接して形成される第２溝部を備える請求項１に記載の医療器具。 The medical device according to claim 1, comprising a second groove spaced apart from the hole and formed adjacent to the groove.
  7. 　前記溝部は、前記穴部の幅以上に形成される請求項１に記載の医療器具。 The medical device according to claim 1, wherein the groove is formed to have a width equal to or greater than that of the hole.
  8. 　前記溝部は、前記穴部の幅よりも小さく形成され、かつ、一の前記穴部を複数通るように形成される請求項１に記載の医療器具。 The medical device according to claim 1, wherein the groove is formed to be smaller than the width of the hole and is formed to pass through one of the holes.
  9. 　前記溝部は複数設けられ、
    　複数の前記溝部において、一の前記溝部と他の前記溝部の深さは互いに異なるように形成される請求項１に記載の医療器具。     A plurality of grooves are provided,
    2. The medical instrument according to claim 1, wherein, among the plurality of grooves, the depth of one of the grooves is different from that of the other grooves.
  10. 　前記穴部は、前記注入針の前記長手方向と交差する側方からみた際に多角形に形成される請求項１に記載の医療器具。 The medical device according to claim 1, wherein the hole is formed in a polygonal shape when viewed from a side crossing the longitudinal direction of the injection needle.
  11. 　前記注入針の前記長手方向において最も基端側の前記穴部に隣接して形成され薬剤の前記外壁面における基端側への流通を阻害するストッパーを備える請求項１に記載の医療器具。 The medical device according to claim 1, further comprising a stopper formed adjacent to the hole on the most proximal side in the longitudinal direction of the infusion needle and blocking the flow of the medicine to the proximal side on the outer wall surface.
PCT/JP2022/045273 2021-12-17 2022-12-08 Medical instrument WO2023112821A1 (en)

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JP2021-204987 2021-12-17

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000076571A1 (en) * 1999-06-16 2000-12-21 Medi-Tech Co., Ltd. Catheter
JP2010125229A (en) * 2008-11-28 2010-06-10 Olympus Corp Medicine administration device
JP2012525181A (en) * 2009-04-29 2012-10-22 カーディオ３ バイオサイエンシズ An infusion catheter for delivering a therapeutic agent to a substrate
US20150314118A1 (en) * 2014-05-01 2015-11-05 Benvenue Medical, Inc. System, apparatus and method for establishing intraosseous vascular access

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000076571A1 (en) * 1999-06-16 2000-12-21 Medi-Tech Co., Ltd. Catheter
JP2010125229A (en) * 2008-11-28 2010-06-10 Olympus Corp Medicine administration device
JP2012525181A (en) * 2009-04-29 2012-10-22 カーディオ３ バイオサイエンシズ An infusion catheter for delivering a therapeutic agent to a substrate
US20150314118A1 (en) * 2014-05-01 2015-11-05 Benvenue Medical, Inc. System, apparatus and method for establishing intraosseous vascular access

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