Needle type catheter

Abstract

A catheter comprises: a needle (2) that pierces into tissue; and an obturator 3 insertable in an extractable manner relative to the needle, the needle having: a hollow needle body 2a with a sharp distal end portion 2t; and a needle hub 2b supporting a proximal end portion 2e, the interior of the needle body comprising: a single lumen 2p that is continuous from the proximal end portion to the distal end portion; and a closed end portion (2c) that closes the lumen, and that has a circular and continuous contour shape in the shape of an arc.

Description

[0001] Cross-references to related applications

[0002] This application is based on and claims priority to a prior Japanese patent application No. 2023-107888, filed on June 30, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to a needle-type catheter for medical use. Background Technology

[0004] Currently, this type of needle catheter includes, for example, resin needles and stainless steel occluders, and is used to introduce diffusers constructed from optical fibers for interstitial irradiation into tissues.

[0005] When using a catheter, first, with the occluder still inserted in the lumen of the needle, the needle is inserted into the tissue. Afterward, the occluder is removed, leaving only the needle in the tissue. Then, a diffuser for interstitial irradiation is inserted into the lumen of the needle remaining in the tissue. In this state, a laser beam emitted from the diffuser irradiates the tissue through the needle, thereby performing phototherapy within the tissue.

[0006] Reference List

[0007] Patent documents

[0008] [PTL 1]JP 2005-523117 A Summary of the Invention

[0009] [Technical Issues]

[0010] Needle catheters are used in the medical field to maintain, restore, and improve human health, for example, in the context of disease diagnosis and treatment. Therefore, needle catheters are required to maintain a certain level of quality in terms of durability, sterility, identifiability, and non-degradability.

[0011] As a quality related to durability, the lumen profile of a conventional needle tip has an angled profile shape with abrupt changes in angle (e.g., a rectangular inner surface shape). Based on this profile shape, for example, when external forces are applied to the needle during diagnosis or treatment, stress tends to concentrate in the angled portion of the tip lumen. Depending on the intensity of the stress, the needle tip may prematurely break or fracture. Therefore, a certain level of durability is required to prevent this from happening.

[0012] As a quality related to sterilizability, needle catheters are constructed from two components (needle and occluder) connected by a Luer taper relationship. With this connection, it is difficult to ensure that sterilizing gas is evenly distributed across the entire front and rear surfaces of each component. In such cases, there is a risk of inadequately sterilized portions remaining (e.g., areas of connection where no gap is formed due to the Luer taper relationship, or the area of ​​the needle lumen in which the occluder is inserted). Therefore, a certain level of sterilizability is required to prevent this from occurring.

[0013] As a quality related to identifiability, needle catheters are pre-prepared in various types with different lengths. In diagnosis and treatment, the needle catheter with the optimal length is selected based on the amount of tissue to be penetrated (puncture depth). In this situation, it is difficult to accurately identify the needle catheter with the optimal length from multiple types within a short timeframe. If the catheter is not selected correctly, the diagnosis or treatment may have to be repeated. Therefore, a certain level of identifiability is required to prevent this from happening.

[0014] As a quality related to non-degradability, in needle-type catheter components (needles and occluders), the needle is constructed from two coupled parts (needle hub and long needle body) made of polyoxymethylene (POM), an engineering plastic. POM is a material (synthetic resin) that is extremely difficult to bond to other substances. In this case, depending on the coupling state, the parts may separate from each other, and for example, the needle body may detach from the needle hub. Therefore, a certain level of non-degradability is required to prevent this from happening.

[0015] The purpose of this invention is to meet the requirements mentioned above and to provide a needle catheter that can maintain a certain level of quality in terms of durability, sterilizability, identifiability, non-degradability, etc.

[0016] [Solution to the problem]

[0017] To achieve this objective, the present invention includes: a needle for puncturing tissue; and an occluder retractably inserted relative to the needle, wherein the needle includes: a hollow and elongated needle body molded from a translucent resin material and having a sharp and closed distal end portion; and a needle seat supporting a proximal end portion of the needle body on the opposite side of the distal end portion, the interior of the needle body being configured to include: a lumen extending continuously from the proximal end portion to the distal end portion; and a closing end closing the lumen at the distal end portion to become the end of the lumen, and the closing end having a circular, arcuate, continuous profile shape.

[0018] Based on this invention, a needle catheter capable of maintaining a certain level of quality in terms of durability, sterilizability, identifiability, and non-degradability can be achieved. The embodiments of the needle catheter described herein can be used in combination with a diffuser for emitting light. These embodiments can be used for the treatment of tumors or lesions (such as cancerous or precancerous lesions). These embodiments can be used in combination with photoactivated therapies or photoactivated drugs for treatment (such as for the treatment of cancer, tumors, or lesions (such as cancerous or precancerous lesions)). Attached Figure Description

[0019] [ Figure 1 ]

[0020] Figure 1 This is a general perspective view of a needle catheter according to an embodiment of the present invention.

[0021] [ Figure 2 ]

[0022] Figure 2 Is as Figure 1 Overall perspective view of the occluder of the needle-type catheter components.

[0023] [ Figure 3 ]

[0024] Figure 3 Is as Figure 1 Overall perspective view of the needle component of the needle-type catheter.

[0025] [ Figure 4 ]

[0026] Figure 4 This is a cross-sectional view of a slug and a needle connected by a Luer taper fit.

[0027] [ Figure 5 ]

[0028] Figure 5 This is a cross-sectional view of the distal end portion of the needle.

[0029] [ Figure 6 ]

[0030] Figure 6 This is a perspective view of a locking collar with identification markings.

[0031] [ Figure 7 ]

[0032] Figure 7 It is a cross-sectional view of the groove structure constructed through the connection area between the occluder and the needle, which are connected by a Luer taper fit. Detailed Implementation

[0033] (Description of the embodiment)

[0034] Figure 1 This is an overall structural view of the needle catheter 1. The needle catheter 1 is used to introduce a diffuser (not shown) constructed of optical fibers for interstitial irradiation into the tissue during interstitial treatment. It should be noted that the needle catheter 1 of this embodiment can be applied to any type of diffuser, for example, not only surface irradiation diffusers that irradiate from the front of the optical fiber, but also side irradiation diffusers that irradiate from the side surface of the optical fiber.

[0035] like Figure 1 As shown, the needle catheter 1 includes a resin needle 2 that is inserted into the tissue, a stainless steel occluder 3 that is retractably inserted relative to the needle 2, and a locking collar 4 that secures the occluder 3 and the needle 2 to each other when the occluder 3 is inserted into the needle 2.

[0036] The locking collar 4 is molded from polypropylene resin and is rotatably mounted on the stopper 3 in the directions of arrows R1 and R2. The locking collar 4 has a threaded portion 4n on its inner circumference. On the other hand, the needle 2 has a threaded portion 2n on its outer circumference (specifically, on the outer circumference of the needle seat 2b, which will be described later).

[0037] In this configuration, with the plug 3 inserted into the needle 2, the locking collar 4 rotates in the direction of arrow R1. At this point, the two threaded portions 2n and 4n are screwed together, and the locking collar 4 is secured to the needle 2. As a result, the plug 3 and the needle 2 are mutually secure.

[0038] Then, the locking collar 4 rotates in the direction of arrow R2 (i.e., the opposite direction to arrow R1). At this time, the locking collar 4 is released from the needle 2 by loosening the threads 2n ​​and 4n on both sides. As a result, the stopper 3 can be pulled out of the needle 2 together with the locking collar 4.

[0039] Here, as preparation before using the needle cannula 1, the occluder 3 is inserted into the needle 2, and the locking collar 4 is tightened to the needle 2 as described above. This secures the occluder 3 and the needle 2 together (i.e., integrates them). At this point, the needle 2 is given the rigidity of the occluder 3 itself. This allows the needle 2 to maintain a profile shape that matches the preset profile shape of the occluder 3 itself.

[0040] Then, needle 2 is inserted into the tissue. Afterward, the occluder 3 is withdrawn along with the locking collar 4, leaving only needle 2 in the tissue. Then, a diffuser for interstitial irradiation is inserted into needle 2, which is now in place in the tissue.

[0041] The needle body is constructed from a semi-transparent tubing, and in some cases, from a white semi-transparent tubing. The semi-transparency enhances light uniformity at the needle surface by first reflecting light emitted from the diffuser multiple times through the needle's walls before emitting light from the needle again. This semi-transparency can be further modified to control light scattering and achieve desired irradiation. Such materials include polyoxymethylene (POM). In this state, when light is emitted from the diffuser, the emitted laser penetrates the needle 2, and the light irradiates the tissue from the needle 2 already placed there. As a result, phototherapy is performed in the tissue at a specific proximal location to the inserted needle.

[0042] Figure 2 This is an overall structural view of the stainless steel blocking device 3. The blocking device 3 includes a blocking device body 3a and a blocking device connecting seat 3b. The blocking device body 3a has a predetermined profile shape. The blocking device connecting seat 3b has a generally cylindrical shape, and its diameter is larger than that of the blocking device body 3a.

[0043] like Figure 2 As shown, the rigidity of the occluder body 3a is sufficient to maintain the preset profile shape. As Figure 2 As an example of the preset profile shape, the occluder body 3a has a solid and long slender cylindrical shape extending from the proximal end portion 3e to the distal end portion 3t. It should be noted that the shape of the occluder body 3a includes, for example, a straight extending shape, a bent extending shape, and an arc extending shape.

[0044] The solid occluder body 3a has a circular cross-sectional view, and its diameter (outer diameter) is set to a constant value from the proximal end portion 3e to the distal end portion 3t. The occluder body 3a includes an arc-shaped contact end 3c at the distal end portion 3t.

[0045] The occluder body 3a is removably inserted into the needle 2 from its distal end portion 3t (specifically, into the lumen 2p of the hollow needle body 2a, which will be described later). Figure 3 and Figure 4 With the occluder body 3a inserted into the needle 2, the contact end 3c of the distal end portion 3t is configured to engage with the closed end 2c of the needle body 2a, which will be described later (see [link to documentation]). Figure 3 and Figure 4 ) to make surface contact.

[0046] like Figure 2As shown, the proximal end portion 3e of the occluder body 3a is located on the opposite side of the distal end portion 3t and is supported by (coupled to) the occluder connector 3b. It should be noted that, as a support (coupling) method, for example, the occluder body 3a and the occluder connector 3b can be integrally molded in a series of manufacturing processes, or the occluder body 3a and the occluder connector 3b can be manufactured separately and then coupled to each other in a post-installation process, for example, mechanically joined or glued together.

[0047] The male conical surface Ms is formed along the outer circumference of the portion of the proximal end portion 3e of the occluder body 3a supported (coupled) by the occluder connector 3b. The male conical surface Ms has a conical shape, and its taper gradient toward the distal end portion 3t of the occluder body 3a is, for example, about 6%.

[0048] The male conical surface Ms is configured such that when the occluder 3 is inserted into the needle 2, it can interact with the female conical surface Ws of the needle 2 as described below (see below). Figure 4 The surfaces are connected (in contact) without any gaps. At this point, a connection region Fc is formed where the male conical surface Ms and the female conical surface Ws are connected without any gaps (see [reference]). Figure 4 Thus, the occluder 3 and the needle 2 are firmly connected together with a Luer taper fit.

[0049] It should be noted that Luer taper is a system applied to standardized small fluid connectors, and, for example, is used to establish a leak-free connection between a male tapered connection point and a mating female tapered connection point.

[0050] Furthermore, the locking collar 4 described above utilizes an anti-loosening structure described later (see below). Figure 4 It is installed on the blocker 3 in a non-detachable manner. As a result, as... Figure 2 As shown, the locking collar 4 can rotate in the directions of arrows R1 and R2 without falling off the blocker 3.

[0051] Figure 3 This is an overall structural view of the resin needle 2. The needle 2 includes a needle body 2a and a needle base 2b. The needle body 2a is molded from a translucent resin material, and its entirety is constructed to be elastically deformable. The needle base 2b has a generally cylindrical shape, and its diameter is larger than that of the needle body 2a.

[0052] like Figure 3 As shown, the needle body 2a has a hollow, long, slender cylindrical shape extending from the proximal end portion 2e to the distal end portion 2t. The hollow needle body 2a has a single lumen 2p configured therein to continuously extend from the proximal end portion 2e to the distal end portion 2t. The cross-sectional view of the lumen 2p is circular, and its diameter (inner diameter) is set to a constant value from the proximal end portion 2e to the distal end portion 2t.

[0053] like Figure 2 and Figure 3 As shown, the diameter (inner diameter) of the lumen 2p of the needle body 2a can be set based on the diameter (outer diameter) of the occluder body 3a described above. In this case, it is preferable that the diameter (inner diameter) of the lumen 2p of the needle body 2a is set in such a way that the occluder body 3a can move smoothly along the lumen 2p of the needle body 2a when it is inserted into or withdrawn from the needle 2.

[0054] It should be noted that, as an example of the setting method, the following three variations can be assumed. As a first variation, the diameter (inner diameter) of the lumen 2p of the needle body 2a is set to be slightly larger than the diameter (outer diameter) of the occluder body 3a described above. As a second variation, the diameter (inner diameter) of the lumen 2p of the needle body 2a is set to be slightly smaller than the diameter (outer diameter) of the occluder body 3a. As a third variation, the diameter (inner diameter) of the lumen 2p of the needle body 2a is set to match the diameter (outer diameter) of the occluder body 3a described above.

[0055] The distal end portion 2t of the needle body 2a having this lumen 2p is sharp and closed. Inside this closed distal end portion 2t, the lumen 2p is constructed to be closed by the closed end 2c to become the end of the lumen 2p.

[0056] Here, the contour shape of the closed end 2c is preferably set as a circular and continuous arc shape, similar to the contour shape of the contact end 3c located at the distal end portion 3t of the occluder body 3a described above. For example, when the mutual contour shapes of the closed end 2c and the contact end 3c are set as arcs, the curvature (or radius of curvature) of the two ends should be set to the same value. In some cases, the radius (R) of the arc is not less than 0.35 mm.

[0057] It should be noted that the needle body 2a is configured such that its proximal end portion 2e, located on the opposite side of the distal end portion 2t, as described above, is supported by the needle seat 2b. The needle seat 2b has a threaded portion 2n on its outer circumference, which can be screwed together with a threaded portion 4n on the inner circumference of the locking collar 4 described above.

[0058] In this case, with the occluder 3 (occluder body 3a) inserted into the needle 2 (the lumen 2p of the needle body 2a) and the two connected (see...), Figure 4 The contact end 3c of the occluder body 3a and the closed end 2c of the needle body 2a make surface contact.

[0059] Figure 4The connection between the occluder 3 and the needle 2 is shown. The needle seat 2b has an annular connection space Ec that connects to the lumen 2p of the needle body 2a. In the connection space Ec, when the occluder 3 is inserted into the needle 2, the occluder body 3a is inserted toward the lumen 2p of the needle body 2a, and the occluder connector 3b and the needle seat 2b are connected to each other.

[0060] like Figure 4 As shown, inside the needle holder 2b, there is a conical surface Ws constructed along its inner circumference and a guide surface Gs extending from the conical surface Ws to the lumen 2p of the needle body 2a. The connecting space Ec is constructed on the spatial region surrounded by these conical surfaces Ws and guide surfaces Gs.

[0061] The female conical surface Ws has a conical shape, and its taper gradient toward the distal end portion 2t of the needle body 2a is, for example, about 6%. In this case, the female conical surface Ws on the inner circumference of the needle seat 2b and the male conical surface Ms on the outer circumference of the occluder connector 3b described above form conical shapes with the same taper gradient as each other.

[0062] The guide surface Gs is formed into a conical shape with a tapered gradient from the conical surface Ws toward the lumen 2p of the needle body 2a. When the occluder 3 is inserted into the needle 2, the guide surface Gs guides the distal end portion 3t of the occluder body 3a toward the lumen 2p of the needle body 2a. At this time, the distal end portion 3t of the occluder body 3a moves along the guide surface Gs while contacting it. This allows the distal end portion 3t of the occluder body 3a to be smoothly and securely inserted into the lumen 2p of the needle body 2a, thus ensuring smooth insertion of the occluder body 3a into the lumen 2p of the needle body 2a.

[0063] On the other hand, the threaded portion 2n is located outside the needle seat 2b along the circumferential direction of the needle seat 2b, and the threaded portion 2n is configured to be screwed together with the threaded portion 4n of the locking collar 4 described above. The locking collar 4 is mounted on the stopper 3 by means of the anti-dislodgement structure described below. The locking collar 4 is mounted to be rotatable along the outer circumference of the stopper connecting seat 3b in the directions of arrows R1 and R2.

[0064] exist Figure 4 In one example of an anti-detachment structure, an annular stop 5 is provided on the outside of the breaker connector 3b, protruding continuously along its outer circumference. In another example, an annular engagement 6 is provided inside the locking collar 4, protruding continuously along its inner circumference.

[0065] In another example of the anti-dislodgement structure, a force spring 7 is provided outside the stopper connector 3b, and through this force spring 7, the engaging part 6 of the locking collar 4 is always kept pressed against the stop 5 of the stopper connector 3b. In this configuration, the engaging part 6 of the locking collar 4 is rotatably held between the stop 5 and the force spring 7. Note that the pressure (i.e., pressing force) of the force spring 7 is set to a level that does not reduce the rotational performance of the locking collar 4. The spring force of the force spring 7 is applied by tightening the stopper 3, which also allows the stopper 3 to be pushed against the closed end 2c and the pin 2 to be pressed. This can also be achieved by mechanical latching.

[0066] As a result, the locking collar 4 can remain mounted on the blocker connector 3b without falling off (i.e., without disengaging from the blocker 3) while in the directions of arrows R1 and R2 (see...). Figure 2 It rotates smoothly on the surface.

[0067] In this case, such as Figure 4 As shown, with the occluder 3 (occluder body 3a) inserted into the needle 2 (the lumen 2p of the needle body 2a), the locking collar 4 is secured to the needle seat 2b by rotating it in the direction of arrow R1. In response to the rotation of the locking collar 4, the needle seat 2b is pulled into the occluder connecting seat 3b. This maintains and constructs a connection region Fc where the male conical surface Ms and the female conical surface Ws are joined without any gaps. The connection region Fc has a conical shape oriented towards the direction in which the occluder 3 is inserted into the needle 2.

[0068] like Figure 4 and Figure 5 As shown, in response to the rotation of the locking collar 4, the contact end 3c of the occluder body 3a makes surface contact with the closed end 2c of the needle body 2a. External forces from the contact end 3c of the occluder body 3a act in a uniformly distributed manner along the closed end 2c of the needle body 2a. Therefore, the rigidity of the occluder body 3a is uniformly imparted to the needle body 2a. As a result, the needle body 2a maintains a straight, slender cylindrical shape while elastically deforming to conform to the contour of the occluder body 3a.

[0069] Figure 6 This is an external view of the locking collar 4 with identification markings. The identification markings identify the type of the needle-type catheter 1 (i.e., needle 2). For example, coloring, uneven markings, symbols, numbers, letters, etc., are considered identification markings, all of which can be designated as visually recognizable to humans. For example, the type of needle 2 identified by such identification markings is considered to be the total length of the needle body 2a when the occluder body 3a is inserted therein.

[0070] like Figure 6 As shown, identification marks can be added to part or all of the outer surface of the locking collar 4. Figure 6 As an example, identification marks (shading indicators) are added to multiple arc-shaped grooves 4p arranged at equal intervals along the outer surface of the locking collar 4. Different colors are added as identification marks depending on the total length of the needle body 2a.

[0071] For example, suppose there are two types of needle bodies 2a (needles 2) with different total lengths, and different colors are added to the locking collars 4 mounted on the plugs 3 to be inserted into each needle 2. For identification marking, the arcuate groove 4p of one locking collar 4 is colored red, and the arcuate groove 4p of the other locking collar 4 is colored blue.

[0072] This allows for easy, quick, and accurate identification of the type of needle 2, i.e., the total length of the needle body 2a, simply by examining the locking collar 4. It should be noted that the aforementioned coloring, uneven markings, symbols, numbers, letters, etc., can be added in combination as identification markers.

[0073] Figure 7 This is a cross-sectional structural view of the groove structure Sg used for distributing sterilizing gases.

[0074] In this embodiment, the needle catheter 1 is sterilized entirely by exposing it to a sterilizing gas atmosphere. In this case, the sterilizing gas must be distributed to all corners of the needle catheter 1 without leakage. For example, it is necessary to ensure that the sterilizing gas is evenly distributed from the occluder 3 and needle 2, which are connected to each other with a Luer taper fit (i.e., the connection area Fc), to the gap between the occluder body 3a and the needle body 2a.

[0075] However, since the positive cone surface Ms and the negative cone surface Ws are connected in the connection region Fc without any gaps, there is a risk that sterilizing gas cannot be dispersed between these surfaces Ms and Ws.

[0076] Therefore, a trench structure Sg is constructed to distribute the sterilizing gas. The trench structure Sg is constructed by penetrating a portion of the connecting region Fc described above. Figure 7 In the example, the groove structure Sg is provided in the occluder connector 3b and is constructed by arranging multiple grooves 8 in a manner that penetrates the connecting region Fc.

[0077] like Figure 7 As shown, multiple grooves 8 are constructed by partially pressing down the outer circumference of the connector 3b, which serves as the connecting area Fc. Each of the multiple grooves 8 is arranged (parallel, substantially parallel) along the insertion direction of the connector 3 relative to the needle 2 and is spaced apart in the circumferential direction.

[0078] In this configuration, multiple grooves 8 can be arranged at equal intervals along the circumferential direction, or they can be arranged at unequal intervals (randomly). Furthermore, it is preferable that the depth and size of the grooves 8 are set to a degree that does not affect the accuracy of the connection between the needle 2 (specifically, the needle seat 2b) and the stopper 3 (specifically, the stopper connector 3b) in the connection area Fc. In one embodiment, the groove is made with Φ = 0.8 ± 0.7 mm, such that the depth of the groove is 0.4 ± 0.35 mm and the width of the groove is 0.8 ± 0.7 mm. Moreover, the shape of the groove 8 can be arbitrarily set, for example, it can have an arcuate cross-section, a triangular cross-section, or a rectangular cross-section.

[0079] According to this groove structure Sg, when the needle catheter 1 is exposed to a sterilizing gas atmosphere, the sterilizing gas flow passes through the connection area Fc that constitutes the groove structure Sg, and the entire front and rear surfaces of both the needle 2 and the occluder 3 are sterilized.

[0080] Figure 7 A flared structure Sf is shown that couples the proximal end portion 2e of the needle body 2a to the needle holder 2b. The flared structure Sf is applied to the proximal end portion 2e of the needle body 2a inside the needle holder 2b. Figure 7 In one example, the flared structure Sf is configured to protrude outward from the needle body 2a at the proximal end portion 2e of the needle body 2a. In another embodiment, the needle seat 2b is constructed of molded resin material to cover the flared structure Sf.

[0081] Here, the protruding form of the flared structure Sf is defined by a first direction D1 orthogonal to the needle body 2a, a second direction D2 from the distal end portion 2t to the proximal end portion 2e of the needle body 2a, and a third direction D3 from the proximal end portion 2e to the distal end portion 2t of the needle body 2a.

[0082] Figure 7 The flared structure Sf shown protrudes outward from the proximal end portion 2e of the needle body 2a in a direction between the first direction D1 and the second direction D2. In this case, the flared structure Sf can protrude continuously along the outer circumference of the needle body 2a, or it can protrude intermittently along the outer circumference of the needle body 2a.

[0083] In any form, the needle holder 2b insert is molded into a flared structure Sf covering the proximal end portion 2e of the needle body 2a. For example, with the proximal end portion 2e of the needle body 2a, which pre-has the flared structure Sf, in a mold (not shown), resin for needle holder molding is injected to cover its periphery, and they are integrally molded together (composite molding). In this configuration, the flared structure Sf engages with the resin-molded needle holder 2b, thereby coupling the needle body 2a to the needle holder 2b.

[0084] (Features and advantages of the described needle catheter embodiments)

[0085] In the embodiments described herein, the contour shape of the closed end 2c, which serves as the end of the lumen 2p, within the distal end portion 2t of the needle body 2a, is set to a circular and continuous arc shape. This eliminates sections with abrupt angle changes, as is common in conventional needle catheters. The embodiments described herein allow stress to be distributed along the arc-shaped closed end 2c. As a result, problems such as cracking, breakage, and damage to the distal end portion 2t of the needle body 2a are prevented.

[0086] In the embodiments described herein, the distal end portion 3t of the occluder body 3a is provided with an arcuate contact end 3c, and the distal end portion 2t of the needle body 2a is provided with a circular, continuously arcuate closed end 2c similar in shape to the contour of the contact end 3c. Therefore, when the occluder 3 (occluder body 3a) is inserted into the needle 2 (the lumen 2p of the needle body 2a) and the two are connected, the contact end 3c of the occluder body 3a and the closed end 2c of the needle body 2a make surface contact. In this case, the external force from the contact end 3c of the occluder body 3a acts in a uniformly distributed manner along the closed end 2c of the needle body 2a. In this configuration, the rigidity of the occluder body 3a is uniformly imparted to the needle body 2a. This allows the needle body 2a to maintain a straight, slender cylindrical shape while elastically deforming to conform to the contour of the occluder body 3a. As a result, the needle 2 (i.e., the needle body 2a) can stably penetrate the tissue.

[0087] In the embodiments described herein, the groove structure Sg is formed by penetrating a portion of the connecting region Fc to distribute sterilizing gas. In this case, with the needle catheter 1 exposed to the sterilizing gas atmosphere, the sterilizing gas flows through the connecting region Fc that forms the groove structure Sg. At this time, the sterilizing gas is evenly distributed from between the needle 2 and the occluder 3, which are connected to each other, to the gap also between the occluder body 3a and the needle body 2a. This allows the sterilizing gas to be distributed to all corners of the needle catheter 1 without leakage. As a result, the entire front and rear surfaces of both the needle 2 and the occluder 3 can be completely sterilized.

[0088] In conventional needle catheters, where the groove structure Sg is absent (as in the standard type), it is impossible to assemble the needle 2 and the occluder 3 together before sterilization. However, in the embodiments described herein, which contain the groove structure Sg, the needle 2 and the occluder 3 can be assembled together before sterilization. This allows for a significant increase in the manufacturing efficiency of the needle catheter 1.

[0089] In the embodiments described herein, visually recognizable identification tags (see...) Figure 4The shading (indicated by the shading) is added to the locking collar 4. This allows for accurate identification of the needle type 2, i.e., the total length of the needle body 2a, in a short time simply by looking at the locking collar 4. As a result, the efficiency of using the needle cannula 1 can be significantly improved.

[0090] In the embodiments described herein, even when the needle 2 (needle body 2a, needle seat 2b) is molded from a material that is extremely difficult to bond to other components (e.g., polyoxymethylene (POM)), a flared structure Sf protruding outward from the needle body 2a is constructed at the proximal end portion 2e of the needle body 2a, and the needle seat 2b is constructed to cover this flared structure Sf with an insert-molded resin material. In this configuration, the flared structure Sf is engaged with the insert-molded needle seat 2b due to an anchoring effect. This holds the needle body 2a in a state that prevents it from detaching from the needle seat 2b, and thus, the needle body 2a is securely coupled to the needle seat 2b.

[0091] (Additional modifications to the embodiments described herein)

[0092] In the embodiments described above, a variation in which the groove structure Sg is provided in the occluder connector 3b is described; however, alternatives, such as a variation in which the groove structure is provided in the needle seat 2b (i.e., the inner circumference of the needle seat 2b in the connecting region Fc) or a variation in which the groove structure is provided in both the occluder connector 3b and the needle seat 2b (i.e., the outer circumference of the occluder connector 3b and the inner circumference of the needle seat 2b in the connecting region Fc), are also included within the scope of the present invention.

[0093] In the embodiments described above, a variation of arranging multiple grooves 8 as groove structure Sg is described; however, alternatives, such as arranging a single (single) groove 8, are also included within the scope of the invention. In this case, the single (single) groove 8 should be arranged (parallel, substantially parallel) along the direction in which the occluder 3 is inserted into the needle 2, penetrating the connecting region Fc.

[0094] In the embodiments described above, a variation in which the flared structure Sf protrudes in the direction between the first direction D1 and the second direction D2 is described as its protruding form; however, alternatives, for example, a variation in which the flared structure Sf protrudes outward along the first direction D1 orthogonal to the needle body 2a, or a variation in which the flared structure Sf protrudes outward from the proximal end portion 2e to the distal end portion 2t in the direction between the first direction D1 and the third direction D3, are also included within the scope of the present invention.

[0095] While one embodiment and certain modifications of the invention have been described, these embodiments and modifications are presented by way of example only and are not intended to limit the scope of the invention. The embodiments and modifications described herein may be embodied in many other forms; furthermore, various omissions, substitutions, and changes may be made to the form of the embodiments described herein without departing from the spirit of the invention. The appended claims and their equivalents are intended to cover such embodiments or modifications that fall within the scope and spirit of the invention.

[0096] Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention is not, in its broad sense, limited to the specific details and representative embodiments shown and described herein. Consequently, various modifications may be made without departing from the spirit or scope of the overall inventive concept as defined by the appended claims and their equivalents.

Claims

1. A needle catheter comprising: a needle to be punctured into a tissue; and an obturator to be extractably inserted with respect to the needle, wherein the needle comprises: a hollow and long needle body molded of a translucent resin material and provided with a sharp and closed distal end portion; and a needle seat to support a proximal end portion of the needle body on an opposite side of the distal end portion, an inside of the needle body is configured to include: one lumen to continuously extend from the proximal end portion to the distal end portion; and a closed end to close the lumen at the distal end portion so as to be an end of the lumen, and the closed end has a circular, arcuate, continuous profile shape.

2. The needle catheter according to claim 1, wherein the obturator comprises a long obturator body to be extractably inserted into the lumen of the hollow needle body, the obturator body is configured to have a rigidity capable of maintaining a preset profile shape and a contact end capable of surface contact with the closed end of the needle body, and in a state where the obturator body is inserted into the lumen of the needle body, the contact end of the obturator body and the closed end of the needle body are in surface contact, and the rigidity of the obturator body is imparted to the needle body so that the needle body is maintained in a shape following a profile of the obturator body.

3. The needle catheter according to claim 1 or claim 2, wherein one or both of the needle and the obturator is provided with a groove structure for allowing a sterilization gas to flow, the groove structure is configured to penetrate a portion of a coupling region in which the obturator is coupled to the needle without any gap therebetween when the obturator is inserted into the needle, and in a state where the needle catheter is exposed to a sterilization gas atmosphere, the sterilization gas flows through the coupling region in which the groove structure is configured, thereby sterilizing entire front and rear surfaces of both the needle and the obturator.

4. The needle catheter according to claim 3, wherein the groove structure is configured by arranging one or a plurality of grooves on one or both of the needle and the obturator in the coupling region, and the groove is configured by partially depressing the coupling region.

5. The needle catheter according to claim 3 or claim 4, wherein in a state where the obturator is inserted into the needle and coupled together without any gap, the coupling region forms a conical shape tapered toward an insertion direction, the one groove is arranged along the insertion direction, and the plurality of grooves are each arranged along the insertion direction and spaced apart along a circumferential direction.

6. The needle catheter according to any one of claims 1 to 5, wherein the needle catheter comprises a locking collar to mutually secure the obturator and the needle when the obturator is inserted into the needle, and the locking collar is configured to be provided with a plurality of locking protrusions to be engaged with a plurality of locking recesses of the needle. The locking collar has an identification mark added to a part or all of the outer surface of the locking collar to enable visual identification of the needle type.

7. The needle catheter of claim 6, wherein The identification mark includes at least coloring, uneven marking, symbol, number, and letter, and The needle type includes at least the total length of the needle body.

8. The needle catheter of any one of claims 1 to 7, wherein The proximal end portion of the needle body is configured by including a flared structure that protrudes outward from the needle body, The needle hub is configured by molding a resin material to cover the flared structure, and The needle body is coupled to the needle hub by having the flared structure snap into the resin-molded needle hub.

9. The needle catheter of claim 8, including one of the following forms as a protruding form of the flared structure: a form that protrudes outward along a first direction orthogonal to the needle body; a form that protrudes outward from the distal end portion toward the proximal end portion in a direction between the first direction and a second direction; and a form that protrudes outward from the proximal end portion toward the distal end portion in a direction between the first direction and a third direction.

10. The needle catheter of claim 8, including one of the following forms as a protruding form of the flared structure: a form that protrudes continuously along an outer circumference of the needle body; and a form that protrudes intermittently along the outer circumference of the needle body.

11. A system comprising: The needle catheter of any one of claims 1 to 10; and a diffuser configured to emit light.

12. Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 in phototherapy or photoimmunotherapy.

13. Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 in the treatment of a tumor or lesion.

14. Use of the needle catheter of any one of claims 1 to 10 or the system of claim 11 in combination with a photoactivatable therapy or a photoactivatable drug.

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