Medical appliance

Abstract

To provide a medical appliance capable of increasing an accumulation amount of medicine with respect to a target tissue.SOLUTION: A medical appliance includes an internal wall surface 11 formed into a long cylindrical shape and forming a channel inside which medicine flows, and an external wall surface 12 formed opposite the internal wall and facing outside. It has an injection needle 10 with an end in a longitudinal direction X closed. The external wall surface and the internal wall surface are connected by a plurality of holes 13 communicating with the channel. The external wall surface is formed into a rugged shape to form a groove part 14. The groove part is provided so as to connect adjacent holes in the longitudinal direction in the plurality of holes.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to medical devices. [Background technology]

[0002] When treating tumors formed in the liver, percutaneous ethanol injection therapy may be performed to locally treat and necrotize cancer cells. The surgeon makes an incision in the abdomen or chest, punctures the liver with a needle cannula, and reaches the affected area of ​​the liver cancer with the tip of the needle. Then, ethanol is injected from the tip of the needle to necrotize the cancer cells.

[0003] A device for administering a cancer therapeutic agent includes a device that includes multiple needles, multiple tanks that are in fluid communication with each of the multiple needles, and multiple actuators that control the fluid pressure in the multiple tanks. In this device, a device is disclosed in which multiple holes are provided on the side of the needle to allow the drug to be administered to the outside. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2016-073762 A Summary of the Invention [Problem to be solved by the invention]

[0005] The present inventors have been actively studying ways to increase the amount of drug accumulated in target tissues such as tumors in order to improve the efficacy of drugs such as cancer therapeutic drugs. Therefore, an object of the present invention is to provide a medical device capable of increasing the amount of drug accumulated in target tissues. [Means for solving the problem]

[0006] One aspect of the present invention is a medical device including an injection needle. The injection needle has an inner wall surface formed in a long cylindrical shape and forming a flow path through which a drug flows, and an outer wall surface formed on the opposite side of the inner wall surface and facing the outside. 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 to form a groove portion. The groove portion is provided so as to connect adjacent holes in the plurality of holes in the longitudinal direction.

[0007] According to the medical device according to one aspect of the present invention, it is possible to increase the amount of drug accumulated in the target tissue. [Brief description of the drawings]

[0008] [Figure 1] 1 is a schematic diagram showing a medical system according to a first embodiment of the present invention. [Diagram 2] 2 is a diagram showing a tip portion of an injection needle constituting the medical system in FIG. 1. FIG. [Diagram 3] 3 is a cross-sectional view showing the hole and groove in the injection needle of FIG. 2, taken along line 3-3 in FIG. 2 and passing through the axial center of the hole. FIG. [Figure 4] 4 is a cross-sectional view showing a groove of the infusion needle taken along line 4-4 in FIG. 2 in a direction intersecting (perpendicular to) the longitudinal direction of the infusion needle in FIG. 2; FIG. [Diagram 5] 13 is a diagram showing the outflow of a drug from an injection needle according to a comparative example having no groove. FIG. [Figure 6] FIG. 6 is a diagram showing the outflow of a drug from an injection needle according to a comparative example, following FIG. 5. [Figure 7] FIG. 7 is a diagram showing the outflow of a drug from an injection needle according to a comparative example, following FIG. [Figure 8] 3 is a diagram showing how a drug flows out from the injection needle in FIG. 2. FIG. [Figure 9] 8, showing how the drug flows out from the injection needle of FIG. [Figure 10] 2. FIG. 9 is a diagram showing how the drug flows out from the injection needle of FIG. [Figure 11] 6 is a cross-sectional view taken along the axial center of a hole, illustrating contact between an injection needle and a target tissue in an injection needle according to a comparative example having no groove as shown in FIG. 5. FIG. [Figure 12] 3 is a cross-sectional view of the injection needle of FIG. 2 taken through the axial centre of the bore, illustrating contact between the injection needle and the target tissue; FIG. [Figure 13] FIG. 13 is a diagram showing a tip portion of an infusion needle according to a first modified example of the first embodiment. [Figure 14] 5 is a cross-sectional view corresponding to FIG. 4, showing the shape of a groove of an infusion needle according to Modification 2 of the first embodiment. FIG. [Figure 15] 5 is a cross-sectional view corresponding to FIG. 4, showing the shape of a groove of an infusion needle according to a third modified example of the first embodiment. FIG. [Figure 16] 5 is a cross-sectional view corresponding to FIG. 4, showing the shape of a groove of an infusion needle according to a fourth modified example of the first embodiment. FIG. [Figure 17] 13 is a cross-sectional view corresponding to FIG. 4, showing the shape of a groove of an infusion needle according to a fifth modified example of the first embodiment. FIG. [Figure 18] FIG. 13 is a diagram showing a tip portion of an infusion needle according to a sixth modified example of the first embodiment. [Figure 19] FIG. 13 is a diagram showing the tip of an infusion needle according to a seventh modified example of the first embodiment. [Figure 20] FIG. 13 is a diagram showing a tip portion of an infusion needle according to an eighth modified example of the first embodiment. [Figure 21] 21 is a cross-sectional view corresponding to FIG. 3, showing the groove and the hole of the infusion needle according to FIG. 20. FIG. [Figure 22] FIG. 13 is a diagram showing a tip portion of an infusion needle according to a ninth modification of the first embodiment. [Diagram 23] FIG. 23 is a diagram showing the tip of an infusion needle according to a tenth modification of the first embodiment. [Figure 24] FIG. 15 is a diagram showing a tip portion of an infusion needle according to an eleventh modification of the first embodiment. [Diagram 25] FIG. 23 is a diagram showing the tip of an infusion needle according to a twelfth modification of the first embodiment. [Figure 26] FIG. 23 is a diagram showing the tip of an infusion needle according to a thirteenth modification of the first embodiment. [Figure 27] FIG. 23 is a diagram showing the tip of an infusion needle according to a fourteenth modification of the first embodiment. [Figure 28] FIG. 23 is a diagram showing the tip of an infusion needle according to a fifteenth modification of the first embodiment. [Figure 29] 29 is a cross-sectional view corresponding to FIG. 3, showing a groove, a hole and a stopper of the injection needle according to FIG. 28. FIG. [Diagram 30] FIG. 23 is a diagram showing the tip of an infusion needle according to a sixteenth modification of the first embodiment. [Diagram 31] 31 is a cross-sectional view corresponding to FIG. 3, showing a groove, a hole and a stopper of the injection needle according to FIG. 30. FIG. [Diagram 32] FIG. 23 is a diagram showing the tip of an infusion needle according to a seventeenth modification of the first embodiment. [Diagram 33] 33 is a cross-sectional view corresponding to FIG. 3, showing a groove, a hole and a stopper of the injection needle according to FIG. 32. FIG. [Diagram 34] FIG. 23 is a diagram showing the tip of an infusion needle according to an eighteenth modification of the first embodiment. [Diagram 35] FIG. 23 is a diagram showing the tip of an infusion needle according to a nineteenth modification of the first embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Hereinafter, the embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely illustrative in order to embody the technical idea of ​​the present invention, and do not limit the present invention. Furthermore, all other possible embodiments, examples, and operating techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

[0010] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product; however, these are merely examples and are not intended to limit the interpretation of the present invention.

[0011] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not dictate any order.

[0012] (First embodiment) A medical system 1 according to a first embodiment will be described below with reference to Fig. 1 to Fig. 4. Fig. 1 is a schematic diagram showing the medical system 1 according to the first embodiment. Fig. 2 is a diagram showing the tip of an infusion needle 10 constituting the medical system 1. Fig. 3 shows the hole 13 and groove 14 of the infusion needle 10 according to Fig. 2, and is a cross-sectional view taken along line 3-3 in Fig. 2, passing through the axial center of the hole 13. Fig. 4 shows the groove 14 of the infusion needle 10, and is a cross-sectional view taken along line 4-4 in Fig. 2, in a direction intersecting (perpendicular to) the longitudinal direction X of the infusion needle 10 according to Fig. 2.

[0013] In this specification, the longitudinal direction X refers to the direction in which the long injection needle 10 extends, and is referred to as the longitudinal direction X. The radial direction refers to 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.). The circumferential direction refers to the direction in which the inner wall surface 11 and the outer wall surface 12 shown in Fig. 4 extend.

[0014] The medical system 1 according to this embodiment can be used when administering a drug such as an anticancer drug to a patient. The medical system 1 will be generally described with reference to FIG. 1, and includes an injection needle 10, an inner cylinder 20, a cannula 30, an outer cylinder 40, a pressure sensor 50, a tube 60, a notification unit 70, and a control unit 80. The medical system 1 is connected to a liquid delivery pump Lt to deliver the drug. In this specification, the injection needle 10, the inner cylinder 20, and the outer cylinder 40 may be referred to as a medical instrument 100. This will be described in detail below.

[0015] The injection needle 10 is formed in an elongated shape, configured to be capable of puncturing a target tissue T such as a tumor site, and configured to allow a drug including an anticancer drug to flow through. The injection needle 10 is formed from a metal material such as SUS304, and is configured with a sharp tip so that it can puncture the target tissue T.

[0016] As shown in FIG. 3 and other figures, the injection needle 10 has an inner wall surface 11, an outer wall surface 12, a hole 13, and a groove 14. The injection needle 10 is formed into a long cylindrical shape, and a flow path is formed inside the inner wall surface 11 so that a drug can be administered to a target tissue T by the inner wall surface 11. In this embodiment, the inner wall surface 11 is formed like a side surface of a cylinder except for the hole 13. However, as long as the drug can flow from the base end side of the flow path toward the tip side of the hole 13, the specific shape of the inner wall surface other than the hole 13 is not limited to the side surface of a cylinder, and may be formed by a side surface of a polygonal prism other than the above.

[0017] The outer wall surface 12 is formed on the opposite side to the inner wall surface 11 and is configured to face the outside. The outer wall surface 12 is formed in an uneven shape to form grooves 14. Similar to the inner wall surface 11, the surface 12a of the outer wall surface 12 other than the holes 13 and grooves 14 is formed like a cylindrical side surface, but similar to the inner wall surface 11, the shape of the surface 12a other than the holes 13 and grooves 14 does not have to be a cylindrical side surface.

[0018] The holes 13 are configured to communicate with the flow path formed by the inner wall surface 11 and to be provided in plurality so as to connect the inner wall surface 11 and the outer wall surface 12. In this embodiment, the holes 13 are configured to be formed along the longitudinal direction X of the cylinder as shown in Fig. 2, but the shape of the holes does not necessarily need to be arranged in the same straight line along the longitudinal direction X as long as the drug flowing through the flow path of the injection needle 10 can be discharged to the outside. The holes 13 are provided on the side surface of the cylindrical shape of the injection needle 10, such as a substantially cylindrical shape, and the tip of the cylindrical shape is formed to be closed.

[0019] In this embodiment, the hole 13 is formed in a substantially circular shape. 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 holes in the longitudinal direction X and three or more holes in the circumferential direction, but the specific number is not limited to the above. In this embodiment, the holes 13 are arranged so that the positions of adjacent holes 13 are aligned in the longitudinal direction X and the circumferential direction. The injection needle 10 is configured to provide holes 13 while sealing (closing) a portion further to the tip side from the hole 13 provided at the tip end. With this configuration, the drug that flows in from the base end side of the injection needle 10 does not flow out from the tip of the injection needle 10, but flows out in the radial direction from the hole 13 formed on the side of the injection needle 10.

[0020] The groove portion 14 is formed on the outer wall surface 12 and is formed so as to be located inward 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 holes 13 in the longitudinal direction X among the plurality of holes 13. The groove portion 14 is formed so as to be provided up to the most distal and most proximal hole portions 13 among the holes 13. In this embodiment, the groove portion 14 is configured to form a recess having a substantially arc shape as shown in FIG. 4 when viewed from the extending direction of the groove portion 14 (the longitudinal direction X in this embodiment). In this embodiment, the groove portion 14 is configured so that the width dimension along the circumferential direction is approximately the same as the diameter dimension of the hole portion 13. That is, the groove portion 14 is configured to be provided in a row with respect to a group of holes 13 lined up along the longitudinal direction X. A plurality of groove portions 14 are provided as shown in FIG. 2, and each groove portion 14 is configured to have the same depth in this embodiment.

[0021] Here, the specifications of the holes 13 and the grooves 14 are illustrated with reference to Figs. 2 and 3, but these are merely examples and the configuration of the injection needle is not limited to the following. The outer diameter d1 of the injection needle 10 forming the outer wall surface 12 can be configured to be 0.70 mm, and the inner diameter d2 of the injection needle 10 forming the inner wall surface 11 can be configured to be 0.50 mm. In the above case, the wall thickness d3 is 0.10 mm (in the range of 0.05 mm to 0.30 mm). 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). The width d5 ​​of the grooves 14 can be set to less than 200 μm, and the depth d6 can be set to 20 to 50 μm.

[0022] The dimensions of the groove 14, that is, the depth d6 is larger than the width d5, which makes it easier for capillary action to occur, and this can promote the flow of the drug through the groove. Specifically, the depth d6 of the groove 14 is preferably 1 / 4 to 1 / 2 the wall thickness d3 of the injection needle 10, and the width d5 ​​is preferably equal to or smaller than the depth d6. The method of processing the groove 14 is not particularly limited, but rolling is preferable from the viewpoint of preventing or suppressing a decrease in strength. Furthermore, it is preferable to finish the outer surface of the inside of the groove 14 to a rough surface by matte processing or the like.

[0023] In this embodiment, the infusion needle 10 is configured to extend linearly as shown in Fig. 2 when no external force is applied, but is not limited to this. In addition, the infusion needle may be configured to be made of a material that is curved when no external force is applied, and to be deformed into a linear shape when an external force is applied.

[0024] The inner cylinder 20 is connected to the base end of the injection needle 10 and has an inner space 21 for allowing the drug to flow through the injection needle 10. A pressure sensor 50, which will be described later, is installed in the inner space 21 of the inner cylinder 20. The inner cylinder 20 is configured so that a tube 60 can be connected thereto, thereby allowing the drug sent from the liquid delivery pump Lt to flow through the inner space 21 of the inner cylinder 20.

[0025] The cannula 30 is disposed outside the injection needle 10 in the radial direction Y, and is configured to be movable relative to the injection needle 10 in the longitudinal direction X. The cannula 30 can be made of the same material as the injection needle 10, and may also be called an outer cylinder needle. The outer cylinder 40 is configured integrally with the cannula 30, and is configured to be able to accommodate the inner cylinder 20 therein. The outer cylinder 40 and the inner cylinder 20 can be made of plastic such as polypropylene or polyethylene.

[0026] The pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20, and is configured to be able to measure the pressure when the drug is flowing from the liquid delivery pump Lt to the injection needle 10. The pressure sensor 50 is not particularly limited in its specific configuration as long as it can measure the pressure of the drug passing through the internal space 21 of the inner cylinder 20, but one example is a diaphragm-type sensor.

[0027] The tube 60 forms a flow path for circulating the drug delivered from the liquid delivery pump Lt toward the injection needle 10. In this embodiment, the tube 60 is configured to connect the liquid delivery pump Lt and the inner cylinder 20. The tube 60 can be made of a known flexible plastic material. In addition, a known valve or the like can be installed in the tube 60 to switch on and off the flow of the delivered liquid. In this embodiment, the pressure sensor 50 is installed in the internal space 21 of the inner cylinder 20, but the installation location of the pressure sensor is not limited to the internal space of the inner cylinder, and may be any location of the administration route in the medical system 1, such as the internal space of the tube 60.

[0028] 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 employ various notification methods as long as it can notify the user of the determination result of the control unit 80. For example, the notification unit 70 can display the measurement value of the pressure sensor 50 as numbers or characters, display the measurement value of the pressure sensor 50 in a graph in chronological order, or notify by voice.

[0029] The control unit 80 is connected to the pressure sensor 50, the liquid feed pump Lt, and the notification unit 70, and is configured to be able to control the liquid feed pump Lt and the notification unit 70. The control unit 80 includes a processor such as a CPU (Central Processing Unit) and a GPU (Graphics Processing Unit), a main storage such as a memory, an auxiliary storage such as an HDD (Hard Disc Drive) and an SSD (Solid State Drive), and the like.

[0030] The liquid delivery pump Lt is connected to the medical system 1 and configured to circulate a drug toward the injection needle 10. As shown in Fig. 1, the liquid delivery pump Lt includes a syringe Lt1, a plunger Lt2, and a motor Lt3. The syringe Lt1 has an internal space for accommodating a drug, is configured so that the plunger Lt2 can be inserted from the base end side, and is configured so that a tube 60 can be connected to the tip side. The syringe Lt1 can be configured in the same manner as the inner cylinder 20, etc.

[0031] The plunger Lt2 is configured to be movable (slidable) in a liquid-tight manner while being housed in the internal space of the syringe Lt1. As a result, if the plunger Lt2 moves in a direction that reduces the internal space of the syringe Lt1, the drug can be delivered toward the injection needle 10 through the tube 60 and the inner cylinder 20.

[0032] The motor Lt3 is connected to the plunger Lt2 and generates a driving force to move the plunger Lt2 so that the internal space of the syringe Lt1 changes. In this embodiment, the liquid delivery pump Lt generates a driving force to circulate the drug toward the injection needle 10 by driving the motor Lt3. The motor Lt3 is connected to the plunger Lt2 via a feed screw or the like, so that the rotation of the motor Lt3 can be converted into the translation (linear) movement of the plunger Lt2. The motor Lt3 is configured to be able to rotate clockwise and counterclockwise.

[0033] (Example of use) Next, a usage example of the medical system 1 including the medical instrument 100 will be described.

[0034] First, the operator connects the tube 60 to the inner cylinder 20 and the liquid supply pump Lt. Then, the operator operates the liquid supply pump Lt without inserting the injection needle 10 into the target tissue T, and performs a priming operation to circulate the drug through the inner space of the tube 60 and the inner space 21 of the inner cylinder 20 into the inner space of the injection needle 10. The drug is intended to be administered to the target tissue T, so the operator must be careful when handling the drug that may flow out from the tip of the injection needle 10 during priming.

[0035] After completing priming, the surgeon stores the tip of the injection needle 10 in the internal space of the cannula 30. By moving the medical instrument 100 with the tip of the injection needle 10 stored in the internal space of the cannula 30, it is possible to prevent or suppress unintentional leakage of the drug during the movement.

[0036] Next, the surgeon makes a small incision around the patient's abdomen, and percutaneously inserts the cannula 30 from the body surface under ultrasonic echo, and moves the tip of the injection needle 10 to the vicinity of the target tissue T such as a tumor site. Next, the surgeon exposes the tip of the injection needle 10 to the outside from the cannula 30, and inserts the tip of the injection needle 10 into the target tissue T to administer the drug to the target tissue T. After completing the administration of the drug, the surgeon places the tip of the injection needle 10 inside the cannula 30, and removes the injection needle 10 and the cannula 30 from the body.

[0037] In the treatment using drugs such as anticancer drugs implemented in this embodiment, there is a demand for an administration method that can increase the amount of drug accumulated in a tumor while suppressing systemic side effects for drugs with strong side effects or drugs with poor deliverability. In response to this, by directly administering the drug to the target tissue T as with the injection needle 10 of the medical system 1 according to this embodiment, the amount of drug accumulated can be increased, and the efficacy of the drug can be improved. In addition, by not administering the drug into the blood vessels as with the medical system 1, exposure to the whole body (side effects) can be reduced.

[0038] As described above, the medical device 100 has an injection needle 10 that is formed in a long cylindrical shape, has an inner wall surface 11 that forms a flow path through which a drug flows, and an outer wall surface 12 that is formed on the opposite side of the inner wall surface 11 and faces the outside, and has a closed tip in the longitudinal direction X. The outer wall surface 12 and the inner wall surface 11 are connected by a plurality of holes 13 that communicate with the flow path. The outer wall surface 12 is formed in an uneven shape to form grooves 14. The grooves 14 are provided to connect adjacent holes 13 in the longitudinal direction X.

[0039] Figures 5 to 7 are views showing the outflow of the drug Md from the hole Sp at the tip of the injection needle DL having no groove according to a comparative example, and Figures 8 to 10 are views showing the outflow of the drug from the hole 13 at the tip of the injection needle 10 according to this embodiment. Figure 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 Figure 5, and Figure 12 is a cross-sectional view showing contact between the injection needle 10 and the target tissue T in the injection needle 10 according to this embodiment.

[0040] There is a certain limit to the penetration of the drug Md into the living tissue, such as in the case of drug administration to tumors that are difficult to penetrate, dense tumors, or tumors with a lot of fiber. In particular, with the injection needle DL of the comparative example, the drug Md may not spread sufficiently, with the drug Md flowing out separately from the hole portion Sp. In addition, the amount of the drug Md flowing out from the hole portion Sp is likely to be biased, as shown in FIG. 7. As described above, the injection needle DL of the comparative example has a relatively small area of ​​the part that flows out the drug, and the amount of the drug Md that flows out is likely to be biased, so that the drug Md cannot be administered in a sufficient amount into the tumor from the hole portion Sp, and as a result, the drug efficacy may be relatively low.

[0041] In contrast, the medical device 100 according to this embodiment provides the groove portion 14 on the injection needle 10 as described above, thereby making it possible to increase the liquid surface area through which the drug Md can flow between the target tissue T and the outer surface of the injection needle 10 as shown in Fig. 12. This allows the drug Md to flow widely through the groove portion 14 on the outer surface of the injection needle 10, allowing the drug Md to diffuse over a wide area within the tissue. Even if there are parts of the tumor where the drug Md has difficulty penetrating, the drug Md can flow along the groove portion 14 to parts where the drug Md can relatively easily penetrate.

[0042] In addition, by the drug Md traveling through the groove portion 14, the amount of drug Md flowing out of the hole portion 13 can be made uniform or close to uniform, as shown in FIG. 10. This allows the drug Md to act over a wider range by administration, improving the efficacy of the drug. In addition, by forming the groove portion 14 in a concave shape, it is possible to easily reflect ultrasonic waves emitted from an ultrasonic echo probe. This makes it easier to position the area with multiple needle holes inside the tumor during the puncture procedure in an ultrasonic echo image, and improves the visibility of the injection needle 10.

[0043] (Variation 1) FIG. 13 is a side view showing an injection needle 10a of a medical device according to Modification 1. In the first embodiment, the hole 13 has been described as being substantially circular in shape when viewed from the side. However, as long as the drug Md flowing through the flow path, which is the internal space of the injection needle, can be discharged to the outside, the specific shape of the hole is not limited to a circle. In addition to the above, the hole 13a can be configured as a polygon such as a rhombus when viewed from the side intersecting the longitudinal direction X as shown in FIG. 13. The polygon that configures the hole may be a triangle, a square other than a rhombus, a hexagon, or other polygon. By configuring in this way, the strength of the tip of the injection needle 10 can be improved.

[0044] The configuration of the medical device other than the hole 13a is the same as that of the first embodiment, and the usage examples are also the same as those of the first embodiment, so the description will be omitted. The usage examples of the second and subsequent modifications described later are also the same as those of the first embodiment, so the configurations different from the first embodiment will be described, and the description of the common configurations and usage examples will be omitted.

[0045] (Modifications 2 to 5) 14 to 17 are views of the groove 14b of the injection needle 10b to the groove 14e of the injection needle 10e of the medical instruments according to Modifications 2 to 5, viewed in the groove extension direction. In the first embodiment, it has been described that the groove 14 has a substantially arc shape when viewed in the longitudinal direction X in which the groove extends.

[0046] However, the specific shape of the groove is not limited to a substantially arc shape. The groove may be configured to include an attracting portion that promotes the flow of the drug Md toward the inside in the radial direction Y intersecting with the longitudinal direction X of the injection needle when the drug Md is placed. Specifically, the groove may be configured such that the angle of the corners in the cross-sectional shape of the groove is 90 degrees or less when viewed from the extending direction of the groove.

[0047] More specifically, as shown in FIG. 14, the shape of the groove 14b of the injection needle 10b when viewed from the extending direction of the groove may be formed by cutting out a substantially circular shape into a rectangular shape (Modification 2).

[0048] 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 extending direction of the groove may be formed by cutting out a substantially circular shape into a triangular shape (Modification 3).

[0049] Alternatively, as shown in FIG. 16, the shape of a groove 14d of an injection needle 10d when viewed from the extending direction of the groove may be formed by cutting out a substantially circular shape into a stepped polygon (Modification 4).

[0050] Furthermore, as shown in FIG. 17, the shape of the groove 14e of the injection needle 10e when viewed from the extending direction of the groove may be formed into a polygonal cut-out shape whose width dimension (the dimension corresponding to the horizontal direction in FIG. 17) becomes smaller radially outward (variant 5).

[0051] In this way, groove 14b of modification 2 to groove 14e of modification 5 are provided with an attracting portion that promotes the liquid level of the drug being placed to be recessed inward in the radial direction Y intersecting with the longitudinal direction X of the injection needle 10. The attracting portion is configured such that the angle of the corners in the cross-sectional shape of the groove is 90 degrees or less when the groove is viewed from the extending direction of the groove, as in grooves 14b to 14e. By configuring in this way, it is possible to prevent the target tissue T from penetrating the inside of the groove and completely blocking the groove, as shown in Figures 14 to 17, and it is possible to easily diffuse the drug Md on the outer surface of the injection needle in the target tissue T such as a tumor.

[0052] (Variation 6) FIG. 18 is a side view showing the tip of the infusion needle 10f of the medical device according to the sixth modification. In the first embodiment, the groove 14 of the infusion needle 10 is described as being formed along the longitudinal direction X, but the specific form of the groove is not limited to the above. The groove 14f may be configured to extend in a spiral shape on the outer surface of the infusion needle as shown in FIG. 18. That is, in this specification, the groove connecting adjacent holes in the "longitudinal direction" does not only mean connecting holes whose positions are not displaced in the circumferential direction and are displaced in the longitudinal direction X. The above description also includes the case where adjacent holes are connected not only in the longitudinal direction X but also in the circumferential direction as shown in FIG. 18 and the like.

[0053] Groove 14f is configured to extend in a spiral shape in this manner, so that ultrasonic waves can be more easily reflected compared to a groove that extends in the longitudinal direction X, such as groove 14.

[0054] (Variation 7) 19 is a side view showing an injection needle 10g of a medical instrument according to Modification 7. In the first embodiment, the groove portion 14 is described as being provided so as to extend along the longitudinal direction X, but the specific form of the groove portion is not limited to the case where only the groove portion 14 is provided along the longitudinal direction X.

[0055] In addition to the above, the injection needle 10g may be configured to include a groove portion 14 extending in the longitudinal direction X similar to the first embodiment and a groove portion 14g between adjacent hole portions 13 arranged in the circumferential direction as shown in FIG. 19 when the hole portions 13 are arranged in the longitudinal direction X and the circumferential direction.

[0056] This configuration can improve the diffusibility of the drug Md in the tissue and can improve the visibility of the injection needle 10g under ultrasonic echo images. The groove 14g of the injection needle 10g is configured to extend in the circumferential direction, so that it can reflect ultrasonic waves more easily than the groove 14 along the longitudinal direction X.

[0057] (Variation 8 to Variation 10) 20 to 23 are views showing the groove 14h of the injection needle 10h of the medical instrument according to Modification 8 to the groove 14m of the injection needle 10m of Modification 10. In the first embodiment, the groove 14 is provided in the multiple holes 13 from the tip end to the base end in the longitudinal direction X.

[0058] However, if a portion through which the drug Md can diffuse is provided on the outer surface of the injection needle, the groove 14h of the injection needle 10h may be configured to extend beyond the hole on the most distal or proximal end side in the groove extension direction as shown in Figures 20 and 21 (Modification 8). The groove 14h is configured to extend through a first portion Pr1 connecting adjacent holes 13 to a second portion Pr2 beyond the hole 13 as shown in Figures 20 and 21.

[0059] Moreover, the groove 14h is configured so that the position of the tip end on the tip side extends to a position separated from the tip of the infusion needle as shown in Fig. 20. However, other than the above, the groove 14k of the infusion needle 10k may be formed so that the tip position of the second part Pr2 reaches the tip (blade surface) of the infusion needle as shown in Fig. 22 (Modification 9).

[0060] Furthermore, the form in which the end of the groove is located beyond the hole portion 13 is not limited to the case where the extension direction of the groove is purely along the longitudinal direction X, but can also be applied to cases where the groove extends in a spiral shape, as shown in groove portion 14m of injection needle 10m (variant example 10).

[0061] In this way, the grooves 14h, 14k, and 14m are configured to extend through the first portion Pr1 that connects the adjacent holes to the second portion Pr2 beyond the holes. This configuration can further improve the diffusibility of the drug.

[0062] (Modification 11, Modification 12) 24 and 25 are side views showing the groove portions of the medical devices according to Modifications 11 and 12. In the first embodiment, it has been described that groove portion 14 is formed so as to connect adjacent hole portions 13. However, the groove portion may be configured to include, in addition to groove portion 14 passing through hole portion 13, a groove portion (corresponding to a second groove portion) that is spaced apart from hole portion 13 and formed adjacent to groove portion 14.

[0063] The specific form of the second groove is not limited to the case where the second groove extends in the longitudinal direction X like the groove 15 of the injection needle 10n shown in Fig. 24 (Modification 11), but may also include the case where the second groove extends in the circumferential direction like the groove 15p of the injection needle 10p shown in Fig. 25 (Modification 12). In Fig. 25, the groove 15p is formed so as to intersect with the groove 14.

[0064] In this way, by providing the injection needle with groove 15 and a second groove 15p, which is spaced apart from hole 13 and formed adjacent to groove 14, in addition to groove 14, the diffusibility of the drug can be improved. Also, the visibility of the injection needle under an ultrasonic echo image can be improved.

[0065] (Variation 13) 26 is a side view showing an injection needle 10q of a medical device according to Modification 13. In the first embodiment, it has been described that the dimension of the groove 14 is approximately the same as the (diameter) dimension of the hole 13. However, the specifications of the groove are not limited to this, and the groove 14q may be configured to be larger than the width dimension of the hole 13.

[0066] In this manner, by ensuring that groove portion 14q is larger than or equal to the width of hole portion 13, the contact area between the drug Md released from hole portion 13 and target tissue T is increased, improving the diffusivity of the drug and also improving visibility (contrast ability) in ultrasonic echo images.

[0067] (Variation 14) 27 is a side view showing an injection needle 10r of a medical device according to Modification 14. In the first embodiment, it has been described that the grooves 14 are formed in a row for a group of holes 13 aligned in the longitudinal direction X. However, the specific configuration of the grooves is not limited to the case where a row of grooves is provided for a group of holes 13.

[0068] The grooves may be formed to be narrower than one hole 13, as in grooves 14r1 and 14r2 in Fig. 27, and may be configured so that multiple grooves 14r1 and 14r2 pass through one hole 13. In this way, by forming grooves 14r1 and 14r2 narrower than the width of hole 13 and forming one hole 13 so that multiple grooves 14r1 and 14r2 pass through it, the diffusibility of the drug Md can be improved. Also, the visibility (contrast property) of the injection needle under an ultrasonic echo image can be improved.

[0069] (Modifications 15 to 17) Figures 28 and 29 are a side view and a cross-sectional view showing an injection needle 10s of a medical instrument according to Modification 15, and Figures 30 and 31 are a side view and a cross-sectional view showing an injection needle 10t of a medical instrument according to Modification 16. Figures 32 and 33 are a side view and a cross-sectional view showing an injection needle 10u of a medical instrument according to Modification 17.

[0070] In the first embodiment, the groove 14 is provided in the injection needle 10 to improve the diffusion of the drug Md in the target tissue T such as a tumor. However, in addition to the hole 13 and the groove 14, the injection needle may be configured to have a stopper that inhibits the flow of the drug Md released from the hole 13 to the base end side of the outer wall surface 12.

[0071] 28 and 29, a convex shape corresponding to stopper 16 can be provided adjacent to hole 13 on the proximal side of hole 13 closest to the proximal end (variation 15). The convex shape of stopper 16 is provided so as to protrude radially outward from surface 12a surrounding groove 14.

[0072] 28 and 29, the width of the convex shape of stopper 16 is not limited to being equal to or smaller than the diameter of hole 13 as in Fig. 28 etc. In addition to the above, the width of the convex shape may be larger than the diameter of hole 13 as in stopper 16t in Fig. 30 and 31 (Modification 16).

[0073] The shape of the stopper may be formed to be recessed radially inward from the surface 12a surrounding the groove portion 14 of the injection needle 10u, like the stopper 16u in Figures 32 and 33 (Modification 17). By providing the stoppers 16, 16t, 16u in the injection needles 10s, 10t, 10u according to Modifications 15 to 17 in this way, leakage of the drug from the puncture site can be prevented, and diffusion of the drug Md in the target tissue T, such as inside a tumor, can be promoted.

[0074] The present invention is not limited to the above-mentioned embodiment, and various modifications are possible within the scope of the claims. Fig. 34 is a side view showing the tip of an infusion needle 10v according to Modification 18, and Fig. 35 is a side view showing the tip of an infusion needle 10w according to Modification 19.

[0075] In the first embodiment, the holes 13 are arranged to align with adjacent holes in the longitudinal direction X or the circumferential direction. If a group of holes aligned in the longitudinal direction X is defined as a first group, the holes of the first group 13R1 and the holes of the first group 13R2 of the infusion needle 10v may be configured to be offset in position in the longitudinal direction X as shown in Fig. 34 (Modification 18).

[0076] Furthermore, when a group of holes aligned in the circumferential direction is defined as a second group, the holes of the second group 13C1 and the holes of the second group 13C2 of the infusion needle 10w may be configured to be shifted in the circumferential position as shown in Fig. 35 (Modification 19). Note that in Fig. 35, the grooves 14w of the infusion needle 10w are formed to be displaced not only in the longitudinal direction X but also in the circumferential direction so as to connect adjacent holes.

[0077] In addition, in the first embodiment, the grooves are formed to have the same depth. However, the grooves may be configured to have different depths. By configuring in this way, the relatively deep grooves can function mainly as a passage for the drug between the needle holes, and the relatively shallow grooves can function mainly to improve the surface area when contacting the target tissue T. [Explanation of symbols]

[0078] 1 Healthcare 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 Exterior wall surface, Surface 12a (surface surrounding the groove among the outer wall surfaces), 13 hole, 14, 14b, 14c, 14d, 14e, 14f, 14g, 14h, 14k, 14m, 14q, 14r1, 14r2, 14w groove, 14b to 14e groove portions (groove portions having induction portions), 15, 15p groove (second groove), 16, 16u, 16t stopper, 20 Inner cylinder (medical instrument), 40 External cylinder (medical device), 100 medical instruments, Pr1 1st part, Pr2 2nd part, X Longitudinal direction.

Claims

1. The injection needle has an inner wall surface formed in a long cylindrical shape and forming a flow path through which a drug flows, and an outer wall surface formed on the opposite side to the inner wall surface and facing the outside, and has a closed tip end in the longitudinal direction, 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 unevenly to form a groove portion, The groove portion is provided so as to connect adjacent holes in the plurality of holes in the longitudinal direction.

2. The medical device according to claim 1 , wherein the groove portion includes an attracting portion that promotes flow of the drug toward an inner side in a radial direction intersecting with the longitudinal direction of the injection needle when the drug flows through the groove portion.

3. The medical device according to claim 2 , wherein the guide portion has a corner in a cross-sectional shape of the groove that forms an angle of 90 degrees or less when the groove is viewed from a direction in which the groove extends.

4. The medical device according to claim 1 , wherein the groove portion is formed through a first portion connecting adjacent ones of the holes to a second portion beyond the holes.

5. the holes are formed side by side in the longitudinal direction of the infusion needle and side by side in a circumferential direction of the infusion needle that intersects with the longitudinal direction, The medical device according to claim 1 , wherein the groove portion is formed between adjacent holes in the circumferential direction in addition to the longitudinal direction.

6. The medical device of claim 1 , further comprising a second groove portion spaced from the hole portion and formed adjacent to the groove portion.

7. The medical device according to claim 1 , wherein the groove portion is formed to have a width equal to or greater than the width of the hole portion.

8. The medical device according to claim 1 , wherein the groove portion is formed to be smaller than the width of the hole portion and to pass through one of the holes a plurality of times.

9. A plurality of the grooves are provided, The medical device according to claim 1 , wherein the grooves are formed so that the depths of one of the grooves are different from the depths of the other grooves.

10. The medical device according to claim 1 , wherein the hole is formed in a polygonal shape when viewed from a side intersecting the longitudinal direction of the injection needle.

11. 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 injection needle, the stopper inhibiting flow of the drug toward the proximal side on the outer wall surface.

Images