Needle catheter

Abstract

To provide a needle catheter capable of maintaining constant quality in terms of durability, sterilization, identifiability, non-degradability, etc. [Solution] The device comprises a needle 2 to be inserted into tissue, and an obturator 3 that is inserted into the needle so that it can be removed. The needle is molded from a translucent resin material and has a hollow, long needle body 2a with a sharpened, closed tip 2t, and a needle hub 2b that supports a base end 2e of the needle body located on the opposite side of the tip. The interior of the needle body is configured to include a single lumen 2p that continues from the base end to the tip, and a closed end 2c at the tip where the lumen terminates, and the closed end has a rounded, arc-like contour.

Description

Technical Field

[0001] The present invention relates to a medical needle catheter.

Background Art

[0002] Currently, this type of needle catheter comprises, for example, a resin needle and a stainless steel obturator, and is used to introduce a tissue internal irradiation diffuser composed of an optical fiber into the tissue.

[0003] In its use, first, with the obturator inserted into the lumen of the needle, the needle is punctured into the tissue. After that, the obturator is withdrawn, and only the needle is left in the tissue. Then, a tissue internal irradiation diffuser is inserted into the lumen of the needle left in the tissue. In this state, laser light emitted from the diffuser is irradiated into the tissue through the needle, thereby performing phototherapy on the tissue.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] By the way, needle catheters are used in the medical field for the purpose of maintaining, recovering, and enhancing human health, for example, in an environment where diagnosis and treatment of diseases are performed. For this reason, needle catheters are required to constantly maintain qualities such as durability, germicidal property, discriminability, and non-decomposability.

[0006] Regarding durability, conventional needles have a sharply angled, angular contour at the tip of the lumen. This contour shape makes it easy for stress to concentrate in the angular portion of the tip lumen when external forces are applied to the needle during diagnosis or treatment. Depending on the strength of the stress, this could lead to premature fracture or breakage of the needle tip. Therefore, a certain level of durability is required to prevent this.

[0007] Regarding the quality related to sterilization, needle catheters are constructed by joining two components (needle and obturator) using a Luer taper. This type of joining makes it difficult to evenly distribute sterilizing gas across the entire surface of each component. Therefore, there is a risk of insufficient sterilization remaining in areas such as the joint region where the components are joined without gaps due to the Luer taper, or in the needle lumen where the obturator is inserted. For this reason, a certain level of sterilization is required to prevent this.

[0008] Regarding the quality of identifiability, needle catheters are provided in multiple lengths. The optimal length of needle catheter is selected according to the amount of tissue puncture (puncture depth) required for diagnosis or treatment. However, accurately identifying the optimal length of needle catheter from among multiple types in a short time is difficult. If the wrong catheter is selected, there is a risk that the diagnosis or treatment will have to be repeated. Therefore, a certain level of identifiability is required to prevent this.

[0009] Regarding the quality related to non-decomposability, among the components of a needle catheter (needle and obturator), the needle is composed of two parts made of polyacetal (POM), an engineering plastic (needle hub and a long needle body), which are joined together. Polyacetal (POM) is a material (synthetic resin) that is extremely difficult to bond with other materials on its own. Therefore, depending on the bonding state, the parts may separate from each other, and there is a risk that, for example, the needle body may detach from the needle hub. For this reason, a certain level of non-decomposability is required to prevent this from happening.

[0010] The present invention has been made to meet the above-mentioned requirements, and its objective is to provide a needle catheter that can maintain a consistent level of quality in terms of durability, sterilization, identifiability, and non-degradability. [Means for solving the problem]

[0011] To achieve this objective, the present invention comprises a needle for puncturing tissue and an obturator that is removablely inserted into the needle, the needle having a hollow, elongated needle body molded from a translucent resin material and having a sharpened, closed tip, and a needle hub that supports the proximal end of the needle body located on the opposite side of the tip, the interior of the needle body being composed of a single continuous lumen from the proximal end to the tip and a closed end at the tip that closes the lumen to terminate the lumen, the closed end having a rounded, arc-shaped continuous contour. The needle and / or obturator, or both, are provided with a groove structure for the flow of sterilizing gas. The groove structure is formed by passing through a portion of the joint area where the obturator and needle are joined together without any gaps when the obturator is inserted into the needle. When the needle catheter is exposed to an atmosphere of sterilizing gas, the sterilizing gas flows through the joint area where the groove structure is formed, thereby sterilizing the entire front and back surfaces of both the needle and obturator. . [Effects of the Invention]

[0012] According to the present invention, it is possible to realize a needle catheter that can maintain consistent quality in terms of durability, bactericidal properties, identifiability, and non-degradability. The embodiments of the needle catheter described in the present invention are useful when used in combination with a light-emitting diffuser. The embodiments can be used for the treatment of tumors or lesions such as cancerous or precancerous lesions. The embodiments can be used in combination with photoactivation therapy or photoactivating agents for the treatment of cancer, tumors or lesions such as cancerous or precancerous lesions. [Brief explanation of the drawing]

[0013] [Figure 1] An overall perspective view of a needle catheter according to one embodiment of the present invention. [Figure 2] Figure 1 shows an overall perspective view of the obturator, a component of the needle catheter. [Figure 3] Figure 1 shows an overall perspective view of the needle, a component of the needle catheter. [Figure 4] Cross-sectional view of the obturator and needle joined together due to the Lure taper. [Figure 5] Cross-sectional view of the tip of the needle. [Figure 6] A perspective view of a rocking color with identification markings. [Figure 7] A cross-sectional view of a groove structure formed by penetrating the joint area between the obturator and the needle, which are joined together due to the Luer taper. [Modes for carrying out the invention]

[0014] "Content of one embodiment" FIG. 1 is an overall configuration diagram of the needle catheter 1. The needle catheter 1 is used to introduce a tissue irradiation diffuser (not shown) composed of an optical fiber into the tissue during tissue treatment. Note that the needle catheter 1 of the present embodiment can be applied to not only a surface irradiation diffuser that irradiates from the front of the optical fiber but also a side irradiation diffuser that irradiates from the side of the optical fiber, regardless of the type of the diffuser.

[0015] As shown in FIG. 1, the needle catheter 1 includes a resin needle 2 to be punctured into the tissue, a stainless steel obturator 3 that is removably inserted into the needle 2, and a locking collar 4 that fixes the obturator 3 and the needle 2 to each other when the obturator 3 is inserted into the needle 2.

[0016] The locking collar 4 is formed of a polypropylene resin and is mounted rotatably in the directions of arrows R1 and R2 with respect to the obturator 3. The locking collar 4 is provided with a screw portion 4n on its inner circumference. On the other hand, the needle 2 is provided with a screw portion 2n on its outer circumference (specifically, on the outer circumference of a needle hub 2b described later).

[0017] In this case, with the obturator 3 inserted into the needle 2, the locking collar 4 is rotated in the direction of arrow R1. At this time, the two screw portions 2n and 4n are screwed together, so that the locking collar 4 is fastened to the needle 2. As a result, the obturator 3 and the needle 2 are fixed to each other.

[0018] After that, the locking collar 4 is rotated in the direction of arrow R2 (i.e., the direction opposite to arrow R1). At this time, the screwing of the two screw portions 2n and 4n is released, so that the locking collar 4 is detached from the needle 2. As a result, the obturator 3 can be removed from the needle 2 together with the locking collar 4.

[0019] Here, as preparation before using the needle catheter 1, the obturator 3 is inserted into the needle 2, and the locking collar 4 is fastened to the needle 2 as described above. As a result, the obturator 3 and the needle 2 are fixed (i.e., integrated) to each other. At this time, the rigidity of the obturator 3 itself is imparted to the needle 2. Thereby, the needle 2 is maintained in a contour shape that matches the preset contour shape of the obturator 3 itself.

[0020] Subsequently, the needle 2 is punctured into the tissue. After that, the obturator 3 is withdrawn together with the locking collar 4, and only the needle 2 is left in the tissue. Then, an in-tissue irradiation diffuser is inserted into the needle 2 left in the tissue.

[0021] The needle 2 is composed of a translucent tube, and in some cases, a white translucent tube is used. The translucent feature enhances the light uniformity on the surface of the needle 2 (tube), such as the light emitted from the diffuser being reflected multiple times on the inner wall of the needle 2 (tube) and then emitted. The translucent property may be further changed to control light scattering and achieve desired illumination. Such materials include polyacetal (POM). In this state, when light is emitted from the diffuser, the emitted laser light is irradiated into the tissue from the needle 2 left in the tissue. As a result, phototherapy is performed on the tissue in a specific vicinity of the needle 2.

[0022] FIG. 2 is an overall configuration diagram of the stainless-steel obturator 3. The obturator 3 has an obturator body 3a and an obturator hub 3b. The obturator body 3a has a preset contour shape. The obturator hub 3b has a substantially cylindrical shape with a larger diameter than the obturator body 3a.

[0023] As shown in Figure 2, the obturator body 3a has the rigidity to maintain a preset contour shape. In Figure 2, as an example of a preset contour shape, the obturator body 3a has a solid, elongated cylindrical shape extending from the base end 3e to the tip end 3t. The shape of the obturator body 3a can include, for example, a straight-extending shape, a bent-extending shape, or an arc-shaped extending shape.

[0024] The solid obturator body 3a has a circular shape in cross-section, and its diameter (outer diameter) is set to a constant value from the base end 3e to the tip end 3t. The tip end 3t of the obturator body 3a is provided with a rounded, arc-shaped contact end 3c.

[0025] The obturator body 3a is removably inserted from its tip 3t ​​into the lumen 2p of the hollow needle body 2a (see Figures 3-4), which will be described later. When the obturator body 3a is inserted into the needle 2, the contact end 3c of the tip 3t ​​is configured to make planar contact with the closed end 2c of the needle body 2a (see Figures 3-4), which will be described later.

[0026] As shown in Figure 2, the base end 3e of the obturator body 3a is provided on the opposite side of the tip end 3t and is supported (connected) to the obturator hub 3b. As for the method of support (connection), for example, the obturator body 3a and the obturator hub 3b may be integrally molded in a series of manufacturing processes, or the obturator body 3a and the obturator hub 3b may be manufactured separately and then joined to each other in a post-assembly process, for example, by mechanical joining or bonding.

[0027] In the obturator hub 3b, the portion that supports (connects) the base end 3e of the obturator body 3a has a male tapered surface Ms along its outer circumference. The male tapered surface Ms has a conical shape with a tapering slope of, for example, about 6% toward the tip 3t ​​of the obturator body 3a.

[0028] The male tapered surface Ms is configured to allow the obturator 3 to be joined (in contact) without any gaps with the female tapered surface Ws (see Figure 4) of the needle 2, which will be described later. At this time, a joining region Fc (see Figure 4) is formed where the male tapered surface Ms and the female tapered surface Ws are joined without any gaps, thereby creating a robust joint between the obturator 3 and the needle 2 in a Luer taper relationship.

[0029] Luer taper is a system applied to standardized, small-scale fluid connectors, and is a standard for establishing leak-free connections between a male tapered connector and a corresponding female tapered connector in medical devices, for example.

[0030] Furthermore, the locking collar 4 is mounted on the obturator 3 in a way that prevents it from falling off, thanks to a fall prevention structure (see Figure 4) described later. As a result, as shown in Figure 2, the locking collar 4 can be rotated in the directions of arrows R1 and R2 without falling off the obturator 3.

[0031] Figure 3 is an overall diagram of the resin needle 2. The needle 2 consists of a needle body 2a and a needle hub 2b. The needle body 2a is molded from a translucent resin material and is configured to be elastically deformable throughout. The needle hub 2b has a substantially cylindrical shape with a larger diameter than the needle body 2a.

[0032] As shown in Figure 3, the needle body 2a has a hollow, elongated cylindrical shape that extends from the base end 2e to the tip end 2t. Inside the hollow needle body 2a is a single continuous lumen 2p that extends from the base end 2e to the tip end 2t. The lumen 2p is circular in cross-section, and its diameter (inner diameter) is set to a constant value from the base end 2e to the tip end 2t.

[0033] As shown in Figures 2 and 3, the diameter (inner diameter) of the lumen 2p of the needle body 2a can be set based on the diameter (outer diameter) of the obturator body 3a described above. In this case, it is preferable to set the diameter (inner diameter) of the lumen 2p of the needle body 2a so that the obturator body 3a can move smoothly along the lumen 2p of the needle body 2a when inserting or removing the obturator 3 from the needle 2.

[0034] As an example of setting methods, the following three variations are considered: The first variation is to set the diameter (inner diameter) of the lumen 2p of the needle body 2a to be slightly larger than the diameter (outer diameter) of the obturator body 3a described above. The second variation is to set the diameter (inner diameter) of the lumen 2p of the needle body 2a to be slightly smaller than the diameter (outer diameter) of the obturator body 3a described above. The third variation is to set the diameter (inner diameter) of the lumen 2p of the needle body 2a to match the diameter (outer diameter) of the obturator body 3a described above.

[0035] The tip 2t of the needle body 2a, which has such a lumen 2p, is sharpened and closed. Inside this closed tip 2t, a closed end 2c is formed, which closes the lumen 2p so as to be the end of the lumen 2p.

[0036] Here, it is preferable that the contour shape of the closed end 2c be rounded and continuous in an arc shape, similar to the contour shape of the contact end 3c provided at the tip 3t ​​of the obturator body 3a described above. For example, when the contour shapes of the closed end 2c and the contact end 3c are set to be arc shapes, the curvature (or radius of curvature) of both should be set to a value that matches each other. In some cases, the radius of curvature (R) of the arc may be 0.35 mm or more.

[0037] The needle body 2a is constructed such that its base end 2e, located on the opposite side of the aforementioned tip 2t, is supported by the needle hub 2b. The outer circumference of the needle hub 2b is provided with a threaded portion 2n, which is configured to be screwable with a threaded portion 4n provided on the inner circumference of the aforementioned locking collar 4.

[0038] In this case, when the obturator 3 (obturator body 3a) is inserted into the needle 2 (lumen 2p of the needle body 2a) and both are joined together (see Figure 4), the contact end 3c of the obturator body 3a and the closed end 2c of the needle body 2a are in planar contact.

[0039] Figure 4 shows the joined state of the obturator 3 and the needle 2. The needle hub 2b is provided with an annular joining space Ec that is continuous with the lumen 2p of the needle body 2a. In the joining space Ec, when the obturator 3 is inserted into the needle 2, the obturator body 3a is inserted toward the lumen 2p of the needle body 2a, and the obturator hub 3b and the needle hub 2b are joined to each other.

[0040] As shown in Figure 4, the needle hub 2b is provided with a female tapered surface Ws along its inner circumference and a guide surface Gs that extends from the female tapered surface Ws to the lumen 2p of the needle body 2a. The bonding space Ec is formed in the spatial region enclosed by these female tapered surface Ws and guide surface Gs.

[0041] The female tapered surface Ws has a conical shape with a tapering slope of, for example, about 6% toward the tip 2t of the needle body 2a. In this case, the female tapered surface Ws on the inner circumference of the needle hub 2b and the male tapered surface Ms on the outer circumference of the obturator hub 3b described above have conical shapes with the same tapering slope.

[0042] The guide surface Gs has a conical shape with a tapering slope from the female tapered surface Ws toward the lumen 2p of the needle body 2a. When inserting the obturator 3 into the needle 2, the guide surface Gs guides the tip 3t ​​of the obturator body 3a toward the lumen 2p of the needle body 2a. At this time, the tip 3t ​​of the obturator body 3a moves along the guide surface Gs while in contact with it. As a result, the tip 3t ​​of the obturator body 3a is smoothly and reliably inserted into the lumen 2p of the needle body 2a, and the obturator body 3a is smoothly inserted into the lumen 2p of the needle body 2a.

[0043] On the other hand, a threaded portion 2n is provided on the outside of the needle hub 2b along its circumferential direction, and this threaded portion 2n is configured to allow the threaded portion 4n of the locking collar 4 described above to be screwed into it. The locking collar 4 is mounted on the obturator 3 by a fall prevention structure described later. The locking collar 4 is mounted so as to be rotatable along the outer circumference of the obturator hub 3b in the directions of arrows R1 and R2.

[0044] Figure 4 shows an example of a fall prevention structure, in which an annular stopper piece 5 is provided on the outside of the obturator hub 3b, continuously protruding along its outer circumference. On the other hand, an annular locking piece 6 is provided on the inside of the locking collar 4, continuously protruding along its inner circumference.

[0045] Furthermore, a biasing spring 7 is provided on the outside of the obturator hub 3b, and this biasing spring 7 keeps the locking piece 6 of the locking collar 4 constantly pressed toward the stopper piece 5 of the obturator hub 3b. At this time, the locking piece 6 of the locking collar 4 is rotatably held between the stopper piece 5 and the biasing spring 7. The biasing force (i.e., pressing force) of the biasing spring 7 is set to an extent that does not reduce the rotational performance of the locking collar 4. The biasing force of the biasing spring 7 is exerted by tightening the obturator 3, thereby allowing the obturator 3 to apply a pressing force to the needle 2 via the closed end 2c. This can also be achieved by a mechanical latch.

[0046] As a result, the locking collar 4 can be smoothly rotated in the directions of arrows R1 and R2 (see Figure 2) while remaining securely mounted on the obturator hub 3b (i.e., without coming off the obturator 3).

[0047] In this case, as shown in Figure 4, with the obturator 3 (obturator body 3a) inserted into the needle 2 (lumen 2p of the needle body 2a), the locking collar 4 is fastened to the needle hub 2b by rotating it in the direction of arrow R1. At this time, the needle hub 2b is pulled towards the obturator hub 3b in accordance with the rotation of the locking collar 4. This maintains and forms a joint region Fc in which the male tapered surface Ms and the female tapered surface Ws are joined without any gaps. At this time, the joint region Fc has a tapered conical shape in the direction of insertion of the obturator 3 into the needle 2.

[0048] Simultaneously, as shown in Figures 4 and 5, in accordance with the rotation of the locking collar 4, the contact end 3c of the obturator body 3a makes planar contact with the closed end 2c of the needle body 2a. At this time, the external force from the contact end 3c of the obturator body 3a acts evenly distributed along the closed end 2c of the needle body 2a. As a result, the rigidity of the obturator body 3a is uniformly imparted to the needle body 2a. Consequently, the needle body 2a maintains a straight, elongated cylindrical shape while elastically deforming to conform to the contour of the obturator body 3a.

[0049] Figure 6 is an external view of the locking collar 4 with an identification mark. The identification mark identifies the type of needle catheter 1 (i.e., needle 2). Examples of identification marks include coloring, raised marks, symbols, numbers, and letters, all of which can be defined as being visually identifiable by humans. The type of needle 2 identified by such an identification mark is, for example, the total length of the needle body 2a when the obturator body 3a is inserted.

[0050] As shown in Figure 6, identification marks can be added to part or all of the outer surface of the locking collar 4. In Figure 6, as an example, identification marks (hatching) are added to multiple arc-shaped recesses 4p arranged at equal intervals along the outer surface of the locking collar 4. Different colors are applied to the identification marks according to the differences in the overall length of the needle body 2a.

[0051] For example, assuming two needle bodies 2a (needles 2) with different overall lengths, different colors are applied to the locking collars 4 mounted on the obturators 3 inserted into each needle 2. As identification marks, the arc-shaped recess 4p of one locking collar 4 is colored red, while the arc-shaped recess 4p of the other locking collar 4 is colored blue.

[0052] This makes it possible to quickly, easily, and accurately identify the type of needle 2, i.e., the total length of the needle body 2a, simply by glancing at the locking color 4. Furthermore, the aforementioned colorings, embossed marks, symbols, numbers, letters, etc., may be combined and added as identification marks.

[0053] Figure 7 is a cross-sectional view of the groove structure Sg for circulating sterilizing gas. In this embodiment, the needle catheter 1 is sterilized entirely by exposure to a sterilizing gas atmosphere. In this case, it is necessary that the sterilizing gas reaches every corner of the needle catheter 1 without leakage. For example, it is necessary that the sterilizing gas spreads evenly from the space between the obturator 3 and the needle 2, which are joined together in a Luer taper relationship (i.e., the joining region Fc), to the gap between the obturator body 3a and the needle body 2a.

[0054] However, in the bonding region Fc, the male tapered surface Ms and the female tapered surface Ws are joined without any gaps, so there is a risk that the sterilizing gas may not be able to reach the space between these surfaces Ms and Ws.

[0055] Therefore, a groove structure Sg is provided for circulating sterilizing gas. The groove structure Sg is constructed by penetrating a part of the aforementioned joining region Fc. In the example in Figure 7, the groove structure Sg is provided on the obturator hub 3b and is constructed by arranging multiple grooves 8 so as to penetrate the joining region Fc.

[0056] As shown in Figure 7, the multiple grooves 8 are formed by partially recessing the outer circumference of the obturator hub 3b, which is the bonding region Fc. Each of the multiple grooves 8 is arranged (parallel or approximately parallel) along the insertion direction of the obturator 3 relative to the needle 2, and is spaced apart along the circumferential direction.

[0057] In this case, the multiple grooves 8 may be arranged at equal intervals along the circumferential direction, or they may be arranged at uneven intervals (randomly). Furthermore, it is preferable that the depth and size of the grooves 8 be set to such an extent that they do not affect the joining accuracy between the needle 2 (specifically, the needle hub 2b) and the obturator 3 (specifically, the obturator hub 3b) in the joining region Fc. In one embodiment, the grooves are formed with a diameter Φ = 0.8 ± 0.7 mm, a groove depth of 0.4 ± 0.35 mm, and a groove width of 0.8 ± 0.7 mm. Furthermore, the shape of the grooves 8 can be arbitrarily set, for example, to a circular arc shape in cross-section, a triangular shape in cross-section, a rectangular shape in cross-section, etc.

[0058] With this groove structure Sg, when the needle catheter 1 is exposed to a sterilizing gas atmosphere, the sterilizing gas flows through the joint region Fc where the groove structure Sg is formed, thereby sterilizing the entire front and back surfaces of both the needle 2 and the obturator 3.

[0059] Furthermore, Figure 7 shows a flair structure Sf that connects the base end 2e of the needle body 2a to the needle hub 2b. The flair structure Sf is applied to the base end 2e of the needle body 2a inside the needle hub 2b. In Figure 7, as an example, the flair structure Sf is configured to protrude outward from the needle body 2a at the base end 2e of the needle body 2a. On the other hand, the needle hub 2b is constructed by molding a resin material to cover the flair structure Sf.

[0060] Here, in order to define the protruding shape of the flare structure Sf, we assume a first direction D1 perpendicular to the needle body 2a, a second direction D2 from the tip 2t of the needle body 2a toward the base 2e, and a third direction D3 from the base 2e of the needle body 2a toward the tip 2t.

[0061] The flare structure Sf shown in Figure 7 is configured to protrude outward from the base end 2e of the needle body 2a in the direction between the first direction D1 and the second direction D2. In this case, the protrusion of the flare structure Sf may be a continuous protrusion along the outer circumference of the needle body 2a, or it may be an intermittent protrusion along the outer circumference of the needle body 2a.

[0062] In either configuration, the needle hub 2b is insert-molded so as to cover the flared structure Sf at the base end 2e of the needle body 2a. For example, with the base end 2e of the needle body 2a, which already has the flared structure Sf, set in a mold (not shown), a resin for needle hub molding is injected around it to form a single integrated part (composite molding). At this time, the flared structure Sf bites into the resin-molded needle hub 2b, thereby bonding the needle body 2a to the needle hub 2b.

[0063] "Effects of one embodiment" According to this embodiment, within the tip portion 2t of the needle body 2a, the contour shape of the closed end 2c, which is the end of the lumen 2p, is set to be rounded and continuous in an arc shape. In this case, it is possible to eliminate the portion with a sharp change in angle that is common in conventional designs. This allows stress to be distributed along the arc-shaped closed end 2c. As a result, it is possible to prevent malfunctions such as fracture, breakage, or damage to the tip portion 2t of the needle body 2a.

[0064] In this embodiment, the tip 3t ​​of the obturator body 3a is provided with a rounded, arc-shaped contact end 3c, and the tip 2t of the needle body 2a is provided with a rounded, arc-shaped, continuous closed end 2c, similar in shape to the contour of the contact end 3c. When the obturator 3 (obturator body 3a) is inserted into the needle 2 (lumen 2p of the needle body 2a) and the two are joined together, the contact end 3c of the obturator body 3a and the closed end 2c of the needle body 2a are in planar contact. In this case, the external force from the contact end 3c of the obturator body 3a is evenly distributed and acts along the closed end 2c of the needle body 2a. At this time, the rigidity of the obturator body 3a is uniformly imparted to the needle body 2a. As a result, the needle body 2a is maintained in a straight, elongated cylindrical shape while elastically deforming to conform to the contour of the obturator body 3a. As a result, needle 2 (i.e., needle body 2a) can be stably inserted into the tissue.

[0065] According to this embodiment, a groove structure Sg is provided that penetrates a portion of the joining region Fc to allow the sterilizing gas to flow. In this case, when the needle catheter 1 is exposed to an atmosphere of sterilizing gas, the sterilizing gas flows through the joining region Fc where the groove structure Sg is formed. At this time, the sterilizing gas spreads evenly from between the needle 2 and the obturator 3, which are joined together, to the gap between the obturator body 3a and the needle body 2a. This allows the sterilizing gas to spread to every corner of the needle catheter 1 without leakage. As a result, the entire front and back surfaces of both the needle 2 and the obturator 3 can be sterilized evenly.

[0066] According to this embodiment, in the case of the conventional type without the groove structure Sg, it was not possible to assemble the needle 2 and the obturator 3 before sterilization. However, in the case of the present invention with the groove structure Sg, it is possible to assemble the needle 2 and the obturator 3 before sterilization. This dramatically improves the manufacturing efficiency of the needled catheter 1.

[0067] According to this embodiment, a visually identifiable identification mark (see hatching in Figure 4) is attached to the locking collar 4. As a result, the type of needle 2, i.e., the total length of the needle body 2a, can be accurately identified in a short time simply by glancing at the locking collar 4. This dramatically improves the efficiency of using the needle catheter 1.

[0068] According to this embodiment, even when the needle 2 (needle body 2a, needle hub 2b) is molded from a material that is extremely difficult to bond to other components (for example, polyacetal (POM)), a flare structure Sf is formed at the base end 2e of the needle body 2a, protruding outward from the needle body 2a, and the needle hub 2b is formed by insert molding a resin material to cover this flare structure Sf. At this time, the flare structure Sf bites into the insert-molded needle hub 2b due to the anchoring effect. As a result, the needle body 2a is kept from coming off the needle hub 2b, and the needle body 2a can be firmly bonded to the needle hub 2b.

[0069] "Variations" In the embodiment described above, a variation in which the groove structure Sg is provided on the obturator hub 3b was assumed and explained. However, alternatively, variations in which the groove structure is provided on the needle hub 2b (i.e., on the inner circumference of the needle hub 2b in the bonding region Fc), or variations in which the groove structure is provided on both the obturator hub 3b and the needle hub 2b (i.e., on both the outer circumference of the obturator hub 3b and the inner circumference of the needle hub 2b in the bonding region Fc) are also included within the technical scope of the present invention.

[0070] In the embodiments described above, variations in which multiple grooves 8 are arranged as the groove structure Sg were assumed and explained. However, alternatively, for example, variations in which one (single) groove 8 is arranged are also included within the technical scope of the present invention. In this case, the one (single) groove 8 should be arranged (parallel or substantially parallel) along the insertion direction of the obturator 3 to the needle 2 so as to penetrate the bonding region Fc.

[0071] In the embodiments described above, a variation was assumed in which the flare structure Sf protrudes between the first direction D1 and the second direction D2. However, alternatively, variations such as those that protrude outward along the first direction D1 perpendicular to the needle body 2a, or those that protrude outward between the first direction D1 and the third direction D3 from the base end 2e to the tip end 2t, are also included within the technical scope of the present invention.

[0072] Although one embodiment of the present invention and several variations have been described above, these embodiments and variations are presented as examples and are not intended to limit the scope of the invention. These embodiments and variations can be implemented in a variety of other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and variations are included in the scope and spirit of the invention, as well as in the claims of the invention and its equivalents. [Explanation of symbols]

[0073] 1...Needle catheter, 2...Needle, 2n...Screw portion, 2a...Needle body, 2b...Needle hub, 2c...Obstruction end, 2e...Proximal end, 2p...Lumen, 2t...Tip, 3...Obturator, 3a...Obturator body, 3b...Obturator hub, 3c...Contact end, 3e...Proximal end, 3t...Tip, 4...Locking collar, 4n...Screw portion, 4p...Arc-shaped recess, 5...Stopper piece, 6...Locking piece, 7...Biasing spring, 8...Groove, D1...First direction, D2...Second direction, D3...Third direction, Ec...Joint space, Fc...Joint region, Gs...Guide surface, Sf...Flare structure, Sg...Groove structure.

Claims

1. The needle that is inserted into the tissue, The invention comprises an obturator that is removablely inserted into the needle, The aforementioned needle is A hollow, elongated needle body molded from a translucent resin material, with a sharpened and closed tip, The needle body includes a needle hub that supports the base end portion located on the opposite side of the tip portion, The inside of the needle body is, A single lumen extending continuously from the base to the tip, The tip portion includes a closed end that closes the lumen so as to be the end of the lumen, The aforementioned closed end has a rounded, arc-shaped, continuous contour. Either the needle or the obturator, or both, are supplied with a sterilizing gas. A groove structure is provided to allow for flow. The groove structure is configured to penetrate a portion of the joining region that is joined to each other without gaps when the obturator is inserted into the needle, A needle catheter in which, when exposed to the atmosphere of the sterilizing gas, the sterilizing gas flows through the joint region in which the groove structure is formed, thereby sterilizing the entire front and back surfaces of both the needle and the obturator.

2. The obturator has an elongated obturator body that is removably inserted into the lumen of the hollow needle body, The obturator body has the rigidity to maintain a preset contour shape, The needle body is configured to have a contact end that can make planar contact with the closed end, The needle catheter according to claim 1, wherein, when the obturator body is inserted into the lumen of the needle body, the contact end of the obturator body and the occluded end of the needle body make planar contact, and the rigidity of the obturator body is imparted to the needle body, thereby maintaining the needle body in a shape that conforms to the contour of the obturator body.

3. The groove structure is configured such that one or more grooves are arranged in either the needle or the obturator, or both, within the joining region. The needle catheter according to claim 1, wherein the groove is configured by partially recessing the joining region.

4. When the obturator is inserted into the needle and joined together without any gaps, the joining region has a tapered conical shape in the direction of insertion. The grooves in 1 are arranged along the insertion direction, The needle catheter according to claim 3, wherein each of the multiple grooves is arranged along the insertion direction and spaced apart along the circumferential direction.

5. The needle catheter is equipped with a locking collar that secures the obturator and the needle to each other when the obturator is inserted into the needle. The needle catheter according to claim 1, wherein the locking collar has an identification mark attached to part or all of its outer surface that allows for visual identification of the type of needle.

6. The aforementioned identification mark includes at least a color, an embossed mark, a symbol, a number, or a letter. The needle catheter according to claim 5, wherein the type of needle includes at least the total length of the needle body.

7. The base end of the needle body is configured to include a flared structure that protrudes outward from the needle body. The needle hub is constructed by molding a resin material to cover the flared structure. The needle catheter according to claim 1, wherein the needle body is connected to the needle hub by the flare structure biting into the resin-molded needle hub.

8. The protruding form of the aforementioned flare structure includes: A form in which the needle body is projected outward along a first direction perpendicular to the needle body, A form in which it protrudes outward between the first direction and the second direction from the tip to the base end, The needle catheter according to claim 7, which includes either the first direction or the third direction from the proximal end toward the tip.

9. The protruding form of the aforementioned flare structure is for phototherapy or photoimmunotherapy, A configuration in which the needle body is continuously protruding along its outer circumference, The needle catheter according to claim 7, which includes any of the following configurations: the needle is intermittently protruding along the outer circumference of the needle body.

10. A system comprising the needle catheter according to any one of claims 1 to 9, and a diffuser configured to emit light.

11. A needle catheter according to any one of claims 1 to 9, for phototherapy or photoimmunotherapy.

12. A needle catheter according to any one of claims 1 to 9, for the treatment of a tumor or lesion.

13. A needle catheter according to any one of claims 1 to 9, used in combination with a photoactivatable therapy or a photoactivatable agent.

14. The system according to claim 10 for phototherapy or photoimmunotherapy.

15. The system according to claim 10 for the treatment of a tumor or lesion.

16. The system according to claim 10, combined with a photoactivatable therapy or a photoactivatable agent.

Images