WO2023112821A1 - Instrument médical - Google Patents

Instrument médical 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
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English (en)
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/fr

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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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Le problème à résoudre par la présente invention est de fournir un instrument médical avec lequel il est possible d'augmenter la quantité d'absorption de médicament dans un tissu cible. La solution selon l'invention porte sur une surface de paroi intérieure 11 qui décrit la forme d'un cylindre allongé et forme un canal à travers lequel un médicament est acheminé, et une surface de paroi extérieure 12 qui est formée sur le côté opposé à la surface de paroi intérieure et fait face à l'extérieur ; et une aiguille d'injection 10 dans laquelle la section de l'extrémité dans la direction longitudinale X est fermée. La surface de la paroi intérieure et la surface de la paroi extérieure sont reliées par une pluralité de trous 13 communiquant avec le canal. La surface de la paroi extérieure est de forme concavo-convexe de manière à former des rainures 14. Les rainures sont disposées de façon à relier, dans la direction longitudinale, des trous adjacents parmi la pluralité de trous.
PCT/JP2022/045273 2021-12-17 2022-12-08 Instrument médical WO2023112821A1 (fr)

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JP2021-204987 2021-12-17
JP2021204987 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 (fr) * 1999-06-16 2000-12-21 Medi-Tech Co., Ltd. Catheter
JP2010125229A (ja) * 2008-11-28 2010-06-10 Olympus Corp 薬剤投与装置
JP2012525181A (ja) * 2009-04-29 2012-10-22 カーディオ３ バイオサイエンシズ 基質に治療薬剤を送達する注入カテーテル
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 (fr) * 1999-06-16 2000-12-21 Medi-Tech Co., Ltd. Catheter
JP2010125229A (ja) * 2008-11-28 2010-06-10 Olympus Corp 薬剤投与装置
JP2012525181A (ja) * 2009-04-29 2012-10-22 カーディオ３ バイオサイエンシズ 基質に治療薬剤を送達する注入カテーテル
US20150314118A1 (en) * 2014-05-01 2015-11-05 Benvenue Medical, Inc. System, apparatus and method for establishing intraosseous vascular access

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