Drug injection device and drug injection assembly

Abstract

A drug injection device and a drug injection assembly are provided that can reduce the burden on the operator and prevent a drug such as a liquid embolic substance from adhering to the hub lumen. [Solution] The drug injection device 1 is a drug injection device in which a catheter 2 is connected to a tip side A and is equipped with a catheter body 21 having a catheter lumen 21a and a hub 22 having a hub lumen 224 joined to the base end side B of the catheter body 21 and communicating with the catheter lumen 21a, and a drug contained in a syringe 31 is supplied from the base end side B, and the drug supplied from the syringe 31 is injected into the living body via the catheter lumen 21a without passing through the hub lumen 224.

Description

[Technical field]

[0001] The present invention relates to a drug injection device and a drug injection assembly. [Background technology]

[0002] In recent years, an attachment that provides a fluid-tight connection between a syringe and a catheter has been proposed (see, for example, Patent Document 1).

[0003] For example, N-butyl cyanoacrylate (NBCA) has been used as a liquid embolization agent for endoscopic sclerotherapy of esophageal and gastric varices. In recent years, however, a liquid mixture of NBCA and the solvent Lipiodol (registered trademark) (hereinafter referred to as NBCA mixture) has been injected into the blood vessels of the living body to treat bleeding diseases or arteriovenous malformations. When such an NBCA mixture is injected through a catheter and comes into contact with blood, it polymerizes instantaneously and becomes a solid substance that occludes the vascular lumen. However, since the viscosity of the NBCA mixture varies depending on the temperature, it is extremely difficult to adjust the timing of polymerization, and it may occlude on the central side or flow to the venous side. In addition, if the catheter is not quickly retracted, the NBCA mixture may adhere to the catheter itself and effective embolization may not be performed, which may make it impossible to remove the catheter.

[0004] The attachment described in Patent Document 1 comprises a first component side main body portion having a tapered base mounting portion at its rear end into which the tip of a syringe is inserted, a first component side connecting portion (screw portion) provided on the first component side main body portion and screwed into a male thread provided on a catheter hub joined to the rear end of the catheter, and a tapered connecting portion provided on the first component side main body portion and inserted halfway into the tapered hub lumen, and the entire attachment is formed from the same material (metal or resin). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2016-220936 A Summary of the Invention [Problem to be solved by the invention]

[0006] The catheter used to inject the NBCA mixture into the living body generally has an inner layer made of a material to which the NBCA mixture does not easily adhere (e.g., fluororesin, polyolefin resin, silicone resin, etc.). On the other hand, the hub is generally made of an easily adhesive material (e.g., ABS, polyamide, etc.) because it is bonded to the outer layer of the catheter. This easily adhesive material is also a material to which the NBCA mixture easily adheres when it adheres. For this reason, in the medical field, precise temperature control and equipment innovation (e.g., using a long needle that can reach the base end of the catheter) are performed to prevent the NBCA mixture from adhering to the hub lumen, which places a burden on the surgeon when injecting the NBCA mixture into the living body.

[0007] Furthermore, even if the attachment is made of a material that is difficult for the NBCA mixture to adhere to, the tip of the connection part of the attachment does not reach the catheter lumen, so there is a risk that the NBCA mixture will adhere to the hub lumen when injected into the living body.

[0008] An object of the present invention is to provide a drug injection device and a drug injection assembly that can reduce the burden on the surgeon and prevent a drug such as a liquid embolic substance from adhering to the hub lumen. [Means for solving the problem]

[0009] [1] A catheter comprising a catheter body having a catheter lumen and a hub having a hub lumen joined to the base end side of the catheter body and communicating with the catheter lumen. 、 Connected to the tip When , an injection tool lumen having both axial ends open, the injection tool lumen being in direct fluid communication with the catheter lumen; The drug contained in the syringe is supplied from the base end. and then introducing the drug directly into the catheter lumen via the injector lumen. A drug injection device, comprising: a tubular distal segment, an intermediate segment and a proximal segment provided in this order from the distal end to the proximal end such that an inner circumferential surface of the tubular distal segment defines the injection tool lumen; The tip segment has an inner circumferential surface having a constant inner diameter over the entire length, the intermediate segment has an inner diameter on the distal end side of an inner circumferential surface that is the same as the inner diameter of the distal segment, the inner diameter of the inner circumferential surface increases stepwise or continuously from the distal end side to the proximal end side, and at least the proximal end side of the inner circumferential surface is formed in a tapered shape in which the inner diameter increases from the distal end side to the proximal end side, The base end segment has an inner circumferential surface that is tapered from the opening on the base end side toward the tip end side in correspondence with the tapered shape of the cylindrical tip of the syringe, The distal end segment and the intermediate segment are formed as tube portions, and at least the inner circumferential surfaces of the distal end segment and the intermediate segment are formed from a material that is difficult to solidify even if the drug adheres thereto, The base end segment is formed as a connector portion from a material that is easily bonded to the tube portion and is joined to the tube portion. Drug injection device. [2] Further comprising a screw portion that is connected to a screw projection provided on the hub, The drug injection device described in [1] above, wherein the base end segment and the threaded portion are integrally formed as the connector portion from a material that is easily bonded to the tube portion and are joined to the tube portion. [3] Further comprising a screw portion that is connected to a screw projection provided on the hub, The base end segment is formed as the connector portion from a material that is easily bonded to the tube portion and is joined to the tube portion, The drug injection device according to [1], wherein the screw portion is rotatably arranged in a circumferential direction relative to the base end segment. [ 4 ] the agent is a liquid containing a cyanoacrylate adhesive, A material that is difficult to solidify even if the drug adheres to it is a fluorine-based resin, an olefin-based resin, or a silicone-based resin. 1 ] A drug injection device as described in the above. [5] The drug injection device described in [1], wherein the axial length of the inner circumferential surface of the intermediate segment is longer than the axial length of the inner circumferential surface of the base-end segment. [6] The drug injection device described in [5], wherein the inner circumferential surface of the intermediate segment at the most distal end is tapered at a predetermined opening angle such that the inner diameter increases from the distal end to the proximal end, and the inner circumferential surface of the most proximal end is tapered at an opening angle larger than the predetermined opening angle such that the inner diameter increases from the distal end to the proximal end. [7] The drug injection device described in [5] above, wherein the inner circumferential surface of the intermediate segment is tapered at a predetermined opening angle such that the inner diameter increases from the tip side to the base end, and the subsequent inner circumferential surface is tapered at an opening angle smaller than the predetermined opening angle such that the inner diameter increases from the tip side to the base end, or the inner diameter is formed to be constant along the axial direction. [ 8 ] further comprising the syringe, The syringe is a syringe in which the medicine is previously contained. Connector The base end side of Connector The above-mentioned [ 1 ] A drug injection device as described in the above. [ 9 ]From [1] above 8

[0023] A pharmaceutical injection device according to any one of the above items. A drug injection assembly comprising the catheter. [ 10 ] The drug injection device includes: When coupled to the catheter, The opening at the distal end of the distal segment The position of the catheter is at a position where the catheter is inserted into the catheter lumen. 9 Drug injection according to the method described in Assembly . [ 11 the catheter body is a catheter body of a microcatheter, The catheter is inserted into the lumen. Tip segmentThe tip side portion of the microcatheter has an outer diameter equal to or smaller than the maximum inner diameter of the microcatheter. 10 Drug injection according to the method described in Assembly . [ 12 ] The distal end side of the hub has a fitting hole in which the proximal end side portion of the catheter body fits into the inner peripheral surface of the hub, 11 ] A drug injection assembly as described in Effect of the Invention

[0010] According to the present invention, it is possible to reduce the burden on the surgeon and to prevent a liquid embolic substance or other drug from adhering to the hub lumen. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 shows an example of a drug injection assembly according to a first embodiment of the present invention, where (a) is an exploded front view, and (b) is a front view of the assembled state. [Diagram 2] FIG. 2 is a longitudinal sectional view showing an example of a catheter. [Diagram 3] FIG. 3 shows the pharmaceutical injection device shown in FIG. 1, where (a) is a front view, (b) is a partial cross-sectional view of part D in (a), and (c) is a partial cross-sectional view showing a modified example of (b). [Figure 4] FIG. 4 is a partial cross-sectional view of part C in FIG. [Diagram 5] FIG. 5 is a perspective view showing an example of the external appearance of a pharmaceutical injection device according to a second embodiment of the present invention. [Figure 6] FIG. 6 is a front view of the pharmaceutical injection device shown in FIG. [Figure 7] FIG. 7 is a plan view of the pharmaceutical injection device shown in FIG. [Figure 8] FIG. 8 is a right side view of the pharmaceutical injection device shown in FIG. [Figure 9] FIG. 9 is a left side view of the pharmaceutical injection device shown in FIG. [Figure 10] FIG. 10 is a cross-sectional view taken along line EE in FIG. [Figure 11]FIG. 11 is a front view of the tube portion shown in FIG. [Figure 12] FIG. 12 is a front view of the pharmaceutical injection device of the first modification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In each drawing, components having substantially the same functions are designated by the same reference numerals, and duplicated explanations will be omitted.

[0013] [First embodiment] 1 shows an example of a drug injection assembly according to a first embodiment of the present invention, where (a) is an exploded front view and (b) is a front view of the assembled state. In this specification, the side inserted into the living body is called the distal end side A, and the side operated by the surgeon is called the proximal end side B.

[0014] (Drug Injection Assembly Configuration) As shown in Figure 1(a), this drug injection assembly 100 comprises a catheter 2 with a hub 22 joined to the base end B of a catheter main body 21, a drug injection device 1 connected to the base end B of the catheter 2, and a syringe 3 connected to the base end B of the drug injection device 1. When using the drug injection assembly 100, as shown in Figure 1(b), the drug injection device 1 is connected to the base end B of the catheter 2, and the syringe 3, in which a drug is contained in a syringe 31, is connected to the base end B of the drug injection device 1. Details of the method of connecting the catheter 2, drug injection device 1 and syringe 3 will be described later.

[0015] As an example of a liquid embolic substance as a drug contained in the syringe 31, for example, a cyanoacrylate adhesive such as N-butyl-2-cyanoacrylate (NBCA) or ethylene vinyl alcohol copolymer (EVOH) can be used. The NBCA mixture is injected into a living body from the catheter 2, and when it comes into contact with blood, it polymerizes instantaneously and becomes a solid substance to occlude the blood vessel cavity. For example, NBCA is generally used by mixing it with an oil-based contrast agent (e.g., Lipiodol (registered trademark)) to dilute it and adjust the polymerization rate to obtain a desired viscosity. The viscosity of the NBCA mixture tends to decrease when heated (e.g., 52 mPa·s (5°C), 18 mPa·s (37°C)), so accurate temperature control is also required. Therefore, in medical settings, precise temperature control and ingenuity of tools (for example, inserting a long injection needle that can reach the base end of the catheter through a closed connector (for example, Shore Plug (registered trademark))) are performed to prevent the NBCA mixture from sticking to the hub lumen. In addition, there is a possibility that the tip of the injection needle may damage the catheter lumen. For these reasons, it is a burden for the surgeon when injecting the NBCA mixture into the living body.

[0016] In this embodiment, therefore, a drug injection device 1 having the functions of both an injection needle and a closed connector is connected between a catheter 2 and a syringe 3, and a drug supplied from a syringe 31 is injected into a living body via the catheter lumen 21a (see FIG. 2) without passing through the hub lumen 224 (see FIG. 2). In other words, the drug is directly introduced into the catheter lumen 21a (see FIG. 2) via the drug injection device 1. That is, the injection device lumen 115 (see FIG. 3(a)) of the drug injection device 1 is in direct fluid communication with the catheter lumen 21a. This reduces the burden on the operator and prevents the drug from adhering to the hub 22 of the catheter 2.

[0017] (Syringe configuration) The syringe 3 is available in a type with a locking mechanism and a type without a locking mechanism. Fig. 1 shows a type with a locking mechanism, but a type without a locking mechanism can also be applied to the drug injection device 1. The syringe 3 shown in Fig. 1 includes a syringe 31 in which a drug is stored, a finger flange 32 fixed to the base end side B of the syringe 31, a plunger 33 that moves within the syringe 31 to push out the drug in the syringe 31, a pressing portion 34 provided on the base end side B of the plunger 33 and receives a pushing force against the plunger 33, a screwing portion 35 as an example of a locking mechanism for screwing with a screwing protrusion 223 provided on the hub 22 of the catheter 2, and a cylindrical tip 36 provided on the tip side A of the syringe 31.

[0018] Screw thread 35a is formed on the inner surface of screw thread 35. Screw thread 35a of screw thread 35 screws into screw projection 116 provided on base end side B of drug injection device 1, thereby connecting syringe 3 to drug injection device 1. Syringe 31 may be provided integrally with drug injection device 1 without using screw thread 35. In this case, syringe 31 may contain the necessary drug in advance.

[0019] As shown in FIG. 3(a) described later, when the barrel tip 36 is inserted into the base end side B of the injection device lumen 115 of the pharmaceutical injection device 1, the outer peripheral surface 36a of the barrel tip 36 comes into contact with the inner peripheral surface 115a that defines the lumen at the most base end side B of the injection device lumen 115 (see the two-dot chain line in FIG. 3(a)). For this reason, in order to ensure liquid tightness between the outer peripheral surface 36a and the inner peripheral surface 115a of the barrel tip 36, the outer peripheral surface 36a and the inner peripheral surface 115a of the barrel tip 36 are formed in a tapered shape (e.g., taper ratio 6 / 100) that conforms to a predetermined standard (e.g., JIS T 3210: sterilized syringe). Note that the outer peripheral surface 36a of the barrel tip 36 does not have to conform to a predetermined standard as long as it has a shape that corresponds to the inner peripheral surface 115a.

[0020] (Catheter configuration) 2 is a longitudinal cross-sectional view showing an example of a catheter 2. The catheter 2 includes a catheter body 21 having a catheter lumen 21a, a hub 22 joined to the outer peripheral surface of the base end side B of the catheter body 21 and having a hub lumen 224 communicating with the catheter lumen 21a, and a strain relief 23 for relieving stress on the base end side B of the catheter body 21.

[0021] For example, a microcatheter with an inner diameter of 1 mm or less can be used as the catheter body 21. The microcatheter is not limited to the above size, and the catheter body 21 is not limited to a microcatheter. In addition, although the catheter body 21 is illustrated in Figures 2 and 4 as having the same outer and inner diameters along the axial direction, the outer and inner diameters may be wider on the base end side B.

[0022] Hub 22 comprises a hub tube 221 having a hub lumen 224 that is open at both axial ends, a pair of wings 222A, 222B provided at opposing positions on the outer peripheral surface of hub tube 221 for changing the orientation of catheter body 21 about the axis, and a screwing protrusion 223 provided on base end side B of hub tube 221 that screws into thread 12a of screwing portion 12 of drug injection device 1.

[0023] The inner circumferential surfaces that define the hub lumen 224 are an inner circumferential surface 224a on the base end side B and an inner circumferential surface 224b on the tip side A. The inner circumferential surface 224a on the base end side B is formed in a tapered shape (taper ratio 6 / 100) corresponding to the intermediate segment 112 described below. Moreover, the inner circumferential surface 224b on the tip side A is formed to have an inner diameter that is the same as the minimum diameter of the inner circumferential surface 224a along the longitudinal direction in order to facilitate insertion of the tip side segment 113 of the pharmaceutical injection device 1.

[0024] A fitting hole 224c having a predetermined axial length (e.g., 5 to 10 mm) is formed on the tip side A of the hub tube 221 for connection to the end of the base side B of the catheter body 21. The end of the base side B of the catheter body 21 is fitted into the fitting hole 224c and joined to the hub tube 221 by a known joining method (e.g., adhesive bonding, fusion, etc.).

[0025] The hub 22 is integrally formed, for example, from a material (eg, ABS, polyamide, etc.) that is easily bonded to the outer circumferential surface of the catheter body 21 by a known molding method (eg, injection molding, compression molding, etc.).

[0026] The strain relief 23 is a member for reinforcing the connection between the catheter body 21 and the hub 22, is provided so as to cover the area including the connection, and has a conical shape tapering toward the tip side A. This makes it possible to impart kink resistance to the catheter 2. The strain relief 23 is formed, for example, from a material having high flexibility or elasticity, such as polyurethane resin, silicone resin, or the like.

[0027] Alternatively, the distal end side A of the hub tube 221 may be thinned, and the thinned distal end may be inserted into the catheter lumen 21a to join the catheter body 21 and the hub 22.

[0028] (Configuration of drug injection device) FIG. 3 shows an example of the drug injection device 1, where (a) is a front view, (b) is a partial cross-sectional view of part D in (a), and (c) is a partial cross-sectional view showing a modified example of (b). FIG. 4 is a partial cross-sectional view of part C in FIG. 1(b). As shown in FIG. 3(a), the drug injection device 1 comprises an injection tube 11 having an injection device lumen 115 with both axial ends open, a screw-type part 12 rotatably provided on the outer circumferential surface side of the injection device tube 11, and a grip part 114 fixedly provided on the outer circumferential surface of the injection device tube 11 and for gripping the drug injection device 1. By providing the screw-type part 12 rotatably relative to the injection tube 11 and further providing the grip part 114, it is possible to hold the grip part 114 with one hand and rotate the screw-type part 12 with the other hand. As a result, the injection tube 11 is inserted into the hub lumen 224 of the catheter 2 without rotating, and the screw thread 12a of the screw-type part 12 can be easily screwed into the screw projection 223. The injection tool tube 11 is an example of a tube.

[0029] The injection tool tube 11 is composed of a proximal segment 111, an intermediate segment 112, and a distal segment 113 provided in order from the proximal end side B. The intermediate segment 112 is an example of a first element. The distal segment 113 is an example of a second element.

[0030] On the proximal end side B of the proximal segment 111, a screwing projection 116 that screws into the thread 35a of the screwing portion 35 of the syringe 3 is formed.

[0031] When the injection tool tube 11 is inserted into the proximal end side B of the hub lumen 224 of the catheter 2, the outer peripheral surface 112a of the intermediate segment 112 comes into overall contact with the inner peripheral surface 224a that defines the lumen of the proximal end side B of the hub lumen 224. For this reason, in order to ensure the liquid tightness between the outer peripheral surface 112a and the inner peripheral surface 224a of the intermediate segment 112, the outer peripheral surface 112a and the inner peripheral surface 224a of the intermediate segment 112 are formed in a tapered shape with a decreasing diameter (for example, a taper ratio of 6 / 100) conforming to a predetermined standard (for example, JIS T 3210: Sterilized Syringe Barrel). Note that if the outer peripheral surface 112a of the intermediate segment 112 has a shape corresponding to the inner peripheral surface 224a, it does not necessarily have to conform to a predetermined standard. Note that the taper angle of the outer peripheral surface 112a of the intermediate segment 112 may be larger than the taper angle of the inner peripheral surface 224a of the catheter 2.

[0032] The tip side A of the injection tool lumen 115 opens as a drug discharge port 113a, and the base side B opens as a drug introduction port 111a. In addition, the injection tool lumen 115 is formed so that the inner diameter becomes smaller stepwise or continuously from the drug introduction port 111a at the base side B toward the drug discharge port 113a at the tip side A, taking into account the drug injection resistance. Specifically, inner circumferential surfaces 115a, 115b, 115c, and 115d are formed from the base side B toward the tip side A as inner circumferential surfaces that define the injection tool lumen 115. As described above, the inner circumferential surface 115a at the most base side B is formed in a tapered shape (taper rate 6 / 100) that tapers down to correspond to the cylindrical tip 36 of the syringe 3. The inner circumferential surface 115b is formed to have the same inner diameter as the minimum diameter of the inner circumferential surface 115a adjacent to the base side B along the longitudinal direction. The inner circumferential surface 115c is formed in a tapered shape in which the inner diameter continuously decreases toward the tip side A. The inner circumferential surface 115d at the tip side A is formed to have the same inner diameter along the longitudinal direction as the minimum diameter of the adjacent inner circumferential surface 115c.

[0033] In consideration of operability when inserting the injection tube 11 into the hub lumen 224, the intermediate segment 112 may be formed so that the wall thickness decreases stepwise or continuously from the base end side B to the tip end side A. For example, the wall thickness of the intermediate segment 112 may be 0.02 to 0.55 mm at the end of the base end side B and 0.015 to 0.425 mm at the end of the tip end side A.

[0034] The tip side segment 113 is formed to have an outer diameter that is the same along the longitudinal direction as the smallest outer diameter of the intermediate segment 112. The tip side segment 113 has an outer diameter slightly smaller than the inner diameter of the catheter lumen 21a because a part of its tip side A is inserted into the catheter lumen 21a. That is, the outer diameter of the tip side segment 113 is preferably slightly smaller than the inner diameter of the catheter lumen 21a (e.g., clearance is 0.005 mm or more and 0.05 mm or less) to enable smooth insertion into the catheter lumen 21a and to prevent the drug from leaking and flowing back.

[0035] Specifically, when the inside diameter of the base end side B of the catheter main body 21 is 0.52 mm, the outside diameter of the tip side segment 113 is preferably 0.51 mm or less (e.g., about 0.47 to 0.51 mm) and the inside diameter is preferably 0.46 mm or less (e.g., about 0.42 to 0.46 mm). By setting the outside diameter and the inside diameter of the tip side segment 113 to the above values, the thickness becomes thin, and the tip side segment 113 can be given flexibility. For example, in order to give flexibility, the thickness of the tip side segment 113 may be 0.005 to 0.045 mm, 0.01 to 0.04 mm, or 0.015 to 0.035 mm. Note that, when the outside diameter and the inside diameter of the catheter main body 21 are expanded on the base end side B, the outside diameter of the tip side segment 113 may be equal to or less than the maximum inside diameter of the microcatheter (e.g., 1 mm or less). The wall thickness of the tip side segment 113 may be, for example, 0.015 mm or more or 0.03 mm or more, taking into consideration the operability (bending rigidity) when inserting into the hub lumen 224 and the catheter lumen 21a. The inner and outer diameters of the tip side segment 113 depend on the inner diameter of the catheter lumen 21a, but may be an inner diameter of 0.10 to 0.92 mm, an outer diameter of 0.40 to 0.95 mm, and a wall thickness of 0.015 to 0.425 mm.

[0036] When the tip side A of the injector tube 11 is inserted into the hub lumen 224 and connected to the catheter 2, the position of the drug discharge port 113a opening at the tip side A of the injector lumen 115 is located at a position that enters the catheter lumen 21a. Specifically, when the intermediate segment 112 and the tip side segment 113 of the drug injection device 1 are inserted into the hub lumen 224, as shown in Fig. 4, the drug discharge port 113a of the tip side segment 113 is designed to enter the tip side A by a predetermined length L (for example, 5 to 15 mm) beyond the base end surface 21b of the catheter main body 21. The length L may be 1 mm or more.

[0037] The base end segment 111, the intermediate segment 112 and the tip end segment 113 are integrally formed by a known molding method (e.g., injection molding, compression molding, blow molding, etc.) from a material to which the liquid embolic substance is unlikely to adhere even if the liquid embolic substance adheres (e.g., fluorine-based resin, polyolefin-based resin, silicone-based resin, etc.).

[0038] As shown in Fig. 3(b), the screw thread portion 12 includes a cylindrical portion 121 and a bottom portion 122. The cylindrical portion 121 has a screw thread 12a formed on its inner surface. The bottom portion 122 has an opening portion 122a with an inner diameter larger than the outer diameter of the outer peripheral surface of the base-end segment 111, and the corners of the end portion of the opening portion 122a are rounded. The material of the screw thread portion 12 is not limited, but the screw thread portion 12 can be formed by a known molding method (e.g., injection molding, compression molding, blow molding, etc.) or by machining a round bar.

[0039] 3(b), a rounded convex portion 111b is provided partially or continuously around the entire outer periphery of the base-end segment 111. When the screw-fitting portion 12 is press-fitted into the injection tube 11 from the tip side A, the bottom portion 122 is positioned between the convex portion 111b and the grip portion 114, and the convex portion 111b serves to prevent the screw-fitting portion 12 from coming off the tip side A.

[0040] 3(c), grip portion 114 may be omitted. In this case, in order to restrict movement of screw portion 12 towards base end side B, convex portion 111c having rounded corners may be provided partially or continuously in the circumferential direction on the outer circumferential surface of base end segment 111. Screw portion 12 may be provided integrally with injection tube 11. Drug injection device 1 does not have to be provided with screw portion 12.

[0041] (Method of manufacturing drug injection device) Next, an example of a manufacturing method of the drug injection device 1 will be described. The injection tube 11 and the screw part 12 are formed separately. That is, the injection tube 11 is integrally formed by injection molding or the like from a material to which the liquid embolic substance is unlikely to adhere even if the liquid embolic substance adheres. The screw part 12 is integrally formed by injection molding or the like from a resin material. Next, as shown in FIG. 3(b), the screw part 12 is press-fitted into the injection tube 11 from the tip side A so that the bottom part 122 of the screw part 12 is located between the convex part 111b and the grip part 114. In this manner, the drug injection device 1 is manufactured.

[0042] (Connection of catheters, drug injection devices and syringes) First, the connection between the catheter 2 and the drug injection device 1 will be described. The distal segment 113 and intermediate segment 112 of the drug injection device 1 are inserted into the hub lumen 224 of the catheter 2, and the screw-threaded portion 12 is screwed onto the screw-threaded projection 223 of the catheter 2. At this time, by holding the grip portion 114 with one hand and turning the screw-threaded portion 12 with the other hand, the screw-threaded projection 223 enters between the threads 12a of the screw-threaded portion 12, and the catheter 2 and the drug injection device 1 are connected.

[0043] Next, a description will be given of the connection between the drug injection device 1 and the syringe 3. The cylindrical tip 36 of the syringe 3, which contains a drug in a syringe 31, is inserted into the injection device lumen 115 of the drug injection device 1 from the base end side B, and by turning the screw-type portion 35, the screw-type projection 116 of the drug injection device 1 enters between the threads 35a of the screw-type portion 35, and the drug injection device 1 and the syringe 3 are connected.

[0044] (Effects of the First Embodiment) The drug injection assembly 100 according to the first embodiment provides the following advantages. (a) By connecting the drug injection device 1, which has the functions of both an injection needle and a closed connector, between the catheter 2 and the syringe 3, it is possible to eliminate the need for ingenuity such as using a long injection needle, thereby reducing the burden on the surgeon. (b) Because the drug discharge port 113a of the drug injection device 1 reaches the catheter lumen 21a, the drug, such as a liquid embolic substance, can be prevented from adhering to the hub lumen 224. (c) Drug injection device 1 has threaded portion 12 at its tip side A for connecting with catheter 2, so that drug injection device 1 can be securely connected to catheter 2. Drug injection device 1 also has threaded projection 116 at its base end B for connecting with syringe 3, so that a syringe 3 with a locking mechanism can be securely connected to drug injection device 1. (d) Because outer circumferential surface 112a of intermediate segment 112 of drug injection device 1 and inner circumferential surface 224a of catheter 2 are tapered at the same taper rate, it is possible to ensure liquid tightness between drug injection device 1 and catheter 2. Furthermore, because inner circumferential surface 115a of base end side B of drug injection device 1 and outer circumferential surface 36a of nozzle 36 of syringe 3 are tapered at the same taper rate, it is possible to ensure liquid tightness between drug injection device 1 and syringe 3.

[0045] [Second embodiment] 5 to 9 show an example of the appearance of a drug injection device 1 according to a second embodiment of the present invention, in which FIG. 5 is a perspective view, FIG. 6 is a front view, FIG. 7 is a plan view, FIG. 8 is a right side view, and FIG. 9 is a left side view. FIG. 10 is a cross-sectional view taken along the line EE in FIG. 7. FIG. 11 is a front view of the tube section shown in FIG. 10. In the first embodiment, the injection tube 11 is integrally formed, but in this embodiment, the connector section 13 and the tube section 14 are formed separately and joined together. In the first embodiment, the screw section 12 is provided so as to be rotatable in the circumferential direction relative to the injection tube 11, but in this embodiment, the screw section 133 is provided by fixing it to the connector section 13. Hereinafter, this embodiment will be described, focusing on the differences from the first embodiment.

[0046] The drug injection device 1 according to this embodiment is formed by joining a connector section 13 having a screw-type portion 133 and a tube section 14 by a known joining method (for example, adhesion, fusion, etc.). The connector section 13 and the tube section 14 may be integrally formed from the same material. Here, the tube section 14 is an example of a tube.

[0047] The connector section 13 includes a tubular base end segment 131 provided on the base end side B, a tubular tip end segment 132 provided on the tip side A of the base end segment 131, and a screw portion 133 fixed to the tip side A of the base end segment 131. A screw projection 134 that screws into the thread 35a of the screw portion 35 of the syringe 3 is formed on the base end side B of the base end segment 131. The outer peripheral surface 132a of the tip end segment 132 is a portion that contacts the inner peripheral surface 224a of the base end side B of the hub lumen 224. The outer peripheral surface 132a of the tip end segment 132 is formed in a tapered shape (taper rate 6 / 100) similar to the outer peripheral surface 112a of the intermediate segment 112 of the first embodiment. The pharmaceutical injection device 1 does not need to include the screw portion 133.

[0048] The connector portion 13 also has an injection tool lumen 135 with both ends open. The base end side B of the injection tool lumen 135 opens as a drug introduction port 131a. The injection tool lumen 135 is formed so that the inner diameter becomes smaller stepwise or continuously from the drug introduction port 131a on the base end side B toward the tip end side A, taking into account the drug injection resistance. Specifically, as the inner circumferential surface defining the injection tool lumen 135, for example, inner circumferential surfaces 135a, 135b, and 135c are formed so that the inner diameter becomes continuously smaller from the base end side B toward the tip end side A. The inner circumferential surface 135a defining the inner lumen on the most base end side B of the injection tool lumen 135 is formed in a tapered shape (taper rate 6 / 100) like the inner circumferential surface 115a of the first embodiment.

[0049] The connector portion 13 is integrally formed with the tube portion 14 from a material (e.g., ABS, polyamide, etc.) that is easily bonded to the tube portion 14 by a known molding method (e.g., injection molding, compression molding, blow molding, etc.). Note that the connector portion 13, like the tube portion 14, may be formed from a material (e.g., fluorine-based resin, polyolefin-based resin, silicone-based resin, etc.) to which the liquid embolic substance does not easily adhere even if the liquid embolic substance adheres to the connector portion 13.

[0050] The screw thread 133 has a screw thread 133a formed on the inner surface thereof, which is screwed into the screw thread protrusion 223 provided on the base end side B of the catheter 2, similar to the screw thread 12 of the first embodiment.

[0051] The tube portion 14 is composed of a first segment 141, a second segment 142, a third segment 143, and a fourth segment 144, which are provided in this order from the base end side B. The third segment 143 is an example of a first element. The fourth segment 144 is an example of a second element.

[0052] The tube portion 14 has a tube lumen 145 with both ends open. The tube lumen 145 is formed so that the inner diameter decreases stepwise or continuously from the base end side B toward the tip side A, taking into account the injection resistance of the drug. Specifically, inner circumferential surfaces 145a, 145b, 145c, and 145d are formed from the base end side B toward the tip side A as inner circumferential surfaces that define the tube lumen 145. The inner circumferential surfaces 145a, 145b, and 145c are formed so that the inner diameter decreases continuously from the base end side B toward the tip side A. The inner circumferential surface 145d at the tip side A is formed to have the same inner diameter as the minimum diameter of the adjacent inner circumferential surface 145c along the longitudinal direction.

[0053] (Size range of each part of the tube) The first segment 141 is formed so that the inner and outer diameters are continuously smaller and the wall thickness is continuously larger from the base end side B to the tip end side A. The wall thickness may be continuously smaller from the base end side B to the tip end side A. Specifically, the first segment 141 may have an axial length of 3 to 10 mm, an inner diameter of 4.00 to 4.20 mm, an outer diameter of 4.03 to 4.27 mm, and a wall thickness of 0.015 to 0.035 mm at the end of the base end side B. The second segment 142 has the same inner and outer diameters and wall thickness over the entire axial length. Specifically, the second segment 142 may have an axial length of 10 to 30 mm, an inner diameter of 0.50 to 3.96 mm, an outer diameter of 1.60 to 4.00 mm, and a wall thickness of 0.02 to 0.55 mm. As shown in Fig. 11, the second segment 142 may be formed so that the inner and outer diameters and the wall thickness continuously decrease from the base end side B to the tip end side A. The third segment 143 is formed so that the inner and outer diameters and the wall thickness continuously decrease from the base end side B to the tip end side A. The fourth segment 144 has the same inner and outer diameters and wall thickness over the entire length in the axial direction. Specifically, the fourth segment 144 can have an axial length of 10 to 30 mm, an inner diameter of 0.10 to 0.92 mm, an outer diameter of 0.40 to 0.95 mm, and a wall thickness of 0.015 to 0.425 mm. However, the inner and outer diameters of the tip side A of the first segment 141 and the inner and outer diameters of the base side B of the second segment 142, the inner and outer diameters of the tip side A of the second segment 142 and the inner and outer diameters of the base side B of the third segment 143, and the inner and outer diameters of the tip side A of the third segment 143 and the inner and outer diameters of the base side B of the fourth segment 144 are each the same size.

[0054] (Typical examples of the sizes of each part of the tube) Representative values ​​for the size of each part of the tube section 14 may be as follows: The first segment 141 has an axial length of 3 mm, an inner diameter of 4.00 mm, an outer diameter of 4.05 mm, and a wall thickness of 0.025 mm at the end of the base side B, and an inner diameter of 1.80 mm, an outer diameter of 1.90 mm, and a wall thickness of 0.05 mm at the end of the tip side A. The second segment 142 has an axial length of 15 mm, an inner diameter of 1.80 mm, an outer diameter of 1.90 mm, and a wall thickness of 0.05 mm. The third segment 143 has an axial length of 8 mm, an inner diameter of 1.80 mm, an outer diameter of 1.90 mm, and a wall thickness of 0.05 mm at the end of the base side B, and an inner diameter of 0.52 mm, an outer diameter of 0.55 mm, and a wall thickness of 0.015 mm at the end of the tip side A. The fourth segment 144 has an axial length of 15 mm, an inner diameter of 0.52 mm, an outer diameter of 0.55 mm, and a wall thickness of 0.015 mm.

[0055] The tube portion 14 is integrally formed from a material to which the liquid embolic substance does not easily adhere even if the liquid embolic substance adheres (e.g., fluororesin, polyolefin resin, silicone resin, etc.) by a known molding method (e.g., extrusion molding, injection molding, compression molding, blow molding, etc.). The tube portion 14 may be formed from a plurality of layers. In this case, of the plurality of layers constituting the tube portion 14, at least the innermost layer may be formed from a material to which the liquid embolic substance does not easily adhere even if the liquid embolic substance adheres.

[0056] (Method of manufacturing drug injection device) Next, an example of a manufacturing method of the drug injection device 1 will be described. The connector portion 13 and the tube portion 14 are formed separately. That is, the connector portion 13 is integrally formed from a resin material by injection molding or the like. The tube portion 14 is integrally formed from a material to which a liquid embolic substance is unlikely to adhere even if the liquid embolic substance adheres, by extrusion molding or the like. Next, as shown in FIG. 10(a), the outer peripheral surfaces of the first segment 141 and the second segment 142 of the tube portion 14 are joined to the inner peripheral surfaces 135b, 135c of the connector portion 13 by a known joining method (adhesion, fusion, etc.). In this manner, the drug injection device 1 is manufactured.

[0057] (Connection of catheters, drug injection devices and syringes) First, the connection between the catheter 2 and the drug injector 1 will be described. The fourth segment 144 and the third segment 143 of the drug injector 1 are inserted into the hub lumen 224 of the catheter 2, and the screwing portion 133 is screwed onto the screwing protrusion 223 of the catheter 2. At this time, holding the screwing portion 133 by hand and turning the entire drug injector 1, the screwing protrusion 223 enters between the threads 133a of the screwing portion 133, and the catheter 2 and the drug injector 1 are connected.

[0058] Next, the connection between the drug injector 1 and the syringe 3 will be described. The barrel tip 36 of the syringe 3 containing the drug in the syringe 31 is inserted into the injector lumen 135 of the drug injector 1 from the proximal end side B, and by turning the screwing portion 35, the screwing protrusion 134 of the drug injector 1 enters between the threads 35a of the screwing portion 35, and the drug injector 1 and the syringe 3 are connected.

[0059] (Effect of the Second Embodiment) According to the drug injection assembly 100 according to the second embodiment, the same effects as those of the first embodiment are achieved, and by forming the tube portion 14 separately from the connector portion 13 by extrusion molding or the like, the wall thickness and the diameter of the tubular portion (the fourth segment 144) inserted into the catheter lumen 21a can be reduced. As a result, it becomes possible to insert the distal end side A of the tube portion 14 into the catheter lumen 21a of the catheter body 21 using a microcatheter.

[0060] [Modification Example 1] FIG. 12 is a front view of the drug injector of Modification Example 1. The drug injector 1 of Modification Example 1 is provided with a syringe 3a on the proximal end side B of the injector tube 11 in the first embodiment. That is, the syringe 31a of the syringe 3a is provided integrally with the injector tube 11 on the proximal end side B of the injector tube 11 in a state where the drug is previously accommodated.

[0061] Specifically, injection tool tube 11 is provided with a joint end 117 instead of screw projection 116, and tip side A of syringe 31a of injector 3a is joined to joint end 117 by a known joining method (e.g., adhesive, fusion, etc.). In addition, inner circumferential surface 115a on the base end side of base end segment 111 shown in FIG. 3(a) is omitted, and inner circumferential surface 115b extends to base end side B.

[0062] Syringe 3a does not have the screw-threaded portion 35 and the nozzle 36 shown in the first embodiment, but has the other components, finger flange 32, plunger 33 and pressing portion 34, similar to the first embodiment.

[0063] According to this modification 1, since the drug is contained in the syringe 31a in advance, it is not necessary to adjust the mixture ratio of NBCA and the oil-based contrast agent, fill the syringe with the NBCA mixture, connect the syringe to a drug injection tool, etc., and therefore it is possible to reduce the burden on the surgeon when injecting the NBCA mixture into a living body.

[0064] [Variation 2] Although not shown, the drug injection device 1 of Modification 2 is the second embodiment, but includes a syringe 3a similar to that of Modification 1 on the base end side B of the connector portion 13. That is, the syringe 31a of the syringe 3a is provided integrally with the connector portion 13 on the base end side B of the connector portion 13 with the drug contained therein in advance.

[0065] Specifically, the connector portion 13 has a joint end portion as shown in FIG. 12 in place of the screw projection 134, and the tip side A of the syringe 31a of the injector 3a is joined to the joint end portion by a known joining method (e.g., adhesive bonding, fusion bonding, etc.).

[0066] According to this modification 2, similarly to the modification 1, it is possible to reduce the burden on the surgeon when injecting the NBCA mixture into a living body.

[0067] Although the embodiment of the present invention has been described above, the embodiment of the present invention is not limited to the above embodiment, and various modifications and implementations are possible. For example, in the above embodiment and modification 1, the NBCA mixture is described as the drug, but the drug is not limited to the NBCA mixture, and other drugs may be used. [Explanation of symbols]

[0068] 1...medicinal injection device, 2...catheter, 3, 3a...syringe, 11...injection device tube, 12...screw portion, 12a...thread, 13...connector portion, 14...tube portion, 21...catheter body, 21a...catheter lumen, 21b...base end surface, 22...hub, 23...strain relief, 31...syringe, 32...finger flange, 33...plunger, 34...pressure portion, 35...screw portion, 35a...thread, 36...tube tip, 100...medicinal injection assembly, 111...base end segment, 111a...medicinal introduction port, 111b, 111c...projection portion, 112...middle segment, 112a...outer circumferential surface, 113...tip end segment, 113a 、144a ...medication discharge port, 114...gripping portion, 115...injection tool lumen, 115a, 115b, 115c, 115d...inner peripheral surface, 116...screw projection, 117...joint end, 121...tubular portion, 122...bottom, 122a...opening, 131...base end segment, 131a...medication introduction port, 132...tip end segment, 132a...outer peripheral surface, 133...screw projection, 133a...thread, 134...screw projection, 135...injection tool lumen, 13 5a, 135b, 135c...inner circumferential surface, 141...first segment, 142...second segment, 143...third segment, 144...fourth segment, 145...tube cavity, 145a, 145b, 145c, 145d...inner circumferential surface, 221...hub tube, 222A, 222B...wing portion, 223...screw projection, 224...hub cavity, 224a, 224b...inner circumferential surface, 224c...fitting hole, A...tip side, B...base side

Claims

1. A drug injection device comprising: a catheter body having a catheter lumen; and a hub joined to a base end side of the catheter body and having a hub lumen communicating with the catheter lumen; when the catheter is connected to a tip end side, an injection tool lumen having both axial ends open directly fluidly communicates with the catheter lumen; and when a drug contained in a syringe is supplied from the base end side, the drug is directly introduced into the catheter lumen via the injection tool lumen, a tubular distal segment, an intermediate segment and a proximal segment provided in this order from the distal end to the proximal end such that an inner circumferential surface of the tubular distal segment defines the injection tool lumen; The tip segment has an inner circumferential surface having a constant inner diameter over the entire length, the intermediate segment has an inner diameter on the distal end side of an inner circumferential surface that is the same as the inner diameter of the distal segment, the inner diameter of the inner circumferential surface increases stepwise or continuously from the distal end side to the proximal end side, and at least the proximal end side of the inner circumferential surface is formed in a tapered shape in which the inner diameter increases from the distal end side to the proximal end side, The base end segment has an inner circumferential surface that is tapered from the opening on the base end side toward the tip end side in correspondence with the tapered shape of the cylindrical tip of the syringe, The distal end segment and the intermediate segment are formed as tube portions, and at least the inner circumferential surfaces of the distal end segment and the intermediate segment are formed from a material that is difficult to solidify even if the drug adheres thereto, The base end segment is formed as a connector portion from a material that is easily bonded to the tube portion and is joined to the tube portion. Drug injection device.

2. Further comprising a screw portion that is connected to a screw projection provided on the hub, the base end segment and the threaded portion are integrally formed as the connector portion from a material that is easily bonded to the tube portion and are joined to the tube portion; The drug injection device according to claim 1.

3. Further comprising a screw portion that is connected to a screw projection provided on the hub, The base end segment is formed as the connector portion from a material that is easily bonded to the tube portion and is joined to the tube portion, The screw portion is provided rotatably in a circumferential direction relative to the base end segment. The drug injection device according to claim 1.

4. The agent is a liquid containing a cyanoacrylate adhesive; The material that is difficult to solidify even when the drug adheres to it is a fluorine-based resin, an olefin-based resin, or a silicone-based resin. The drug injection device according to claim 1.

5. The axial length of the inner peripheral surface of the intermediate segment is longer than the axial length of the inner peripheral surface of the base end segment. The drug injection device according to claim 1.

6. The intermediate segment has an inner peripheral surface closest to the tip that is tapered at a predetermined opening angle such that the inner diameter increases from the tip side to the base side, and the inner peripheral surface closest to the base side that is tapered at an opening angle larger than the predetermined opening angle such that the inner diameter increases from the tip side to the base side. The drug injection device according to claim 5.

7. The intermediate segment has an inner circumferential surface closest to the tip that is tapered at a predetermined opening angle such that the inner diameter increases from the tip side to the base side, and the subsequent inner circumferential surface is tapered at an opening angle smaller than the predetermined opening angle such that the inner diameter increases from the tip side to the base side, or the inner diameter is formed to be uniform along the axial direction. The drug injection device according to claim 5.

8. The syringe further comprises: The syringe is provided integrally with the connector portion on the proximal end side of the connector portion in a state in which the drug is contained in advance. The drug injection device according to claim 1.

9. A drug injection device according to any one of claims 1 to 8, The catheter; A drug injection assembly comprising:

10. When the drug injection device is connected to the catheter, the position of the opening on the tip side of the tip side segment is in a position where it enters the catheter lumen.

10. A drug injection assembly as claimed in claim 9.

11. the catheter body is a catheter body of a microcatheter, a distal portion of the distal segment that is inserted into the catheter lumen has an outer diameter equal to or smaller than a maximum inner diameter of the microcatheter; 11. A drug delivery assembly as claimed in claim 10.

12. The distal end side of the hub has a fitting hole in which the proximal end side portion of the catheter main body fits into the inner peripheral surface of the hub.

12. A drug injection assembly as claimed in claim 11.

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