WO2025234494A1 - Blood collection needle - Google Patents

Abstract

A blood collection needle 10 is provided with: a needle tube 12 that has a sharp needle tip 16; a needle hub 14; and a protector 40 that covers the needle tip 16 after use. The protector 40 has a cover part 60 that covers the needle tip 16, a collar part 38 that is externally inserted into the needle hub 14 and is fixed thereto, and a hinge part 62 that rotatably connects the cover part 60 and the collar part 38. The cover part 60, the collar part 38, and the hinge part 62 are integrally molded resin molded bodies. The needle hub 14 has a plurality of ribs 34 that extend in the axial direction and a flange 35 that extends outward in the radial direction. The collar part 38 has a guide part 52 that is inserted between the ribs 34 and defines a circumferential position around the axis.

Description

blood collection needle

The present invention relates to blood collection needles used in the medical field, and in particular to blood collection needles equipped with a protector that covers the needle tip after use.

In the medical field, a commonly known device for transferring blood from a patient into a blood collection tube or similar is one that uses a blood collection needle and a blood collection tube holder. The needle hub of the blood collection needle has a connection part for connecting to the blood collection tube holder, such as a screw-like protrusion, on the base end side. The blood collection needle is fixed to the blood collection tube holder via this connection part, and the needle tube is connected to the blood collection tube attached to the blood collection tube holder.

Such blood collection needles are equipped with a safety mechanism that covers the needle tip after use to prevent accidental punctures. For example, Patent Document 1 proposes one such safety mechanism: attaching a collar with a protector to the tip tube of a blood collection tube holder.

Japanese Patent Application Laid-Open No. 2018-149026

However, because the protector described in Patent Document 1 is fixed to the blood collection tube holder, the blood collection tube holder is limited to single-use. Furthermore, when the holder is disposed of, the blood collection tube holder is also discarded, resulting in a large amount of medical waste. Therefore, medical settings are calling for a protector to be attached to the blood collection needle rather than the blood collection tube holder, allowing the holder to be reused multiple times.

The problem to be solved by this invention is to provide a new blood collection needle in which a protector is attached to the needle itself.

Below, we will describe preferred embodiments for understanding the present invention. However, each embodiment described below is described as an example and may be used in combination with each other as appropriate. Furthermore, the multiple components described in each embodiment may be recognized and used independently to the greatest extent possible, and may also be used in combination with any of the components described in other embodiments as appropriate. As a result, the present invention is not limited to the embodiments described below, and various other embodiments may be realized.

A first aspect of the blood collection needle disclosed herein comprises a distal needle tube having a sharp needle tip, a needle hub fixed to the distal needle tube, a proximal needle tube provided proximal to the needle hub, and a protector that covers the needle tip after use. The protector accommodates the distal needle tube through a side opening and has a cover that covers the needle tip, a collar that is fitted over and fixed to the needle hub, and a hinge that rotatably connects the cover and collar. The cover, collar, and hinge are integrally molded resin bodies. The needle hub has multiple ribs extending axially and flanges extending radially outward. The collar has guide portions that are inserted between adjacent ribs to determine its position around the axis.

With this blood collection needle, the safety mechanism is provided on the needle hub rather than the blood collection tube holder, allowing the blood collection tube holder to be used multiple times, thereby reducing the amount of medical waste. Furthermore, because the collar portion has a guide portion that is inserted between adjacent ribs, the collar portion and needle hub can be roughly positioned, allowing for a stable process of fixing the collar portion and needle hub. It is sufficient that the position of the collar portion around the axis is roughly defined, and a gap may be formed between the guide portion and the rib. Fixing the collar portion and needle hub can be achieved by various methods, such as fixing by resin melting, bonding with an adhesive, and physical fitting.

In a second aspect of the blood collection needle, in addition to the first aspect, the collar can have a locking and fixing portion that locks with the needle hub and is attached to the needle hub via the locking and fixing portion. With this blood collection needle, the needle hub and collar are fixed by physical locking, allowing for manufacturing without complicating the manufacturing process. Preferably, the locking and fixing portion locks with the needle hub by bringing the collar and needle hub closer together in the axial direction with the guide portion inserted between the ribs. Examples of locking and fixing portions that can be used include a guide portion that frictionally fits or fits concave and convexly with the outer surface of the needle hub, an inner surface of the collar that frictionally fits or fits concave and convexly with the radially outer end surface of the rib, a recess or hole formed in the collar into which a radially outward convex portion of the needle hub is inserted, and a claw formed in the collar that snaps into engagement with the flange of the needle hub.

In a third aspect of the blood collection needle, in addition to the first aspect, the collar portion can be fixed to the needle hub by fusing the base end surface of the guide portion and the tip surface of the flange together. With this blood collection needle, the relatively wide tip surface of the flange is used for fixation, making it easier to ensure strength and improve assembly.

A fourth aspect of the blood collection needle is any one of the first to third aspects, with the collar being a cylindrical body extending further toward the tip than the needle hub, and the connection between the hinge and collar being located further toward the tip than the needle hub.

With this blood collection needle, the hinge position can be set closer to the tip when assembled to the blood collection tube holder, shortening the required axial length of the cover that covers the needle. The small size of the cover makes it easier to store many blood collection needles in the packaging. It also reduces the risk of accidentally grabbing the cover when removing the blood collection needle from the packaging.

A fifth aspect of the blood collection needle is any one of the first to fourth aspects, in addition to which the collar portion is a cylindrical body formed with a larger outer diameter at the tip end than at the base end, and the hinge portion can be connected to the tip end of the collar portion.

With this blood collection needle, the hinge position can be set further outward when assembled to the blood collection tube holder, reducing the risk of unintended malfunctions caused by interference between the blood collection tube holder and the cover when the cover is moved toward the tip by the spring hinge. For example, there are blood collection tube holders that can be threaded onto the threaded portion of the needle hub by pressing a pressure plate that extends laterally, but this reduces the risk of interference between the pressure plate and the cover when connecting the blood collection tube holder and the needle hub, preventing a smooth connection operation.

A sixth embodiment of the blood collection needle comprises a distal needle tube having a sharp needle tip, a needle hub fixed to the distal needle tube, a proximal needle tube provided proximal to the needle hub, and a protector that covers the needle tip after use. The protector accommodates the distal needle tube through a side opening and has a cover that covers the needle tip, a collar that is fitted over and fixed to the needle hub, and a pivoting part that pivotally connects the cover and collar. The collar is a cylindrical body that extends distally beyond the needle hub, and the connection between the pivoting part and collar is located distally beyond the needle hub.

With this blood collection needle, the safety mechanism is located on the needle hub rather than the blood collection tube holder, allowing the blood collection tube holder to be used multiple times, thereby reducing medical waste. Furthermore, the connection between the pivoting part and the collar is located distally of the needle hub, thereby reducing the axial length of the cover. The axial length of the cover can be further reduced by providing a connection with the pivoting part at the distal end of the collar and positioning one end of the cover distally of the connection between the collar and pivoting part when the cover is displaced proximally. Furthermore, if the collar has a large-diameter cylindrical part and a small-diameter cylindrical part, the axial length of the cover can be further reduced by making the axial length of the large-diameter cylindrical part longer than the axial length of the small-diameter cylindrical part. The collar and needle hub can be fixed together by various methods, such as by melting a resin, bonding with an adhesive, or physically fitting. The pivoting part may be a hinge connecting the collar and cover, or a pin connecting the collar and cover. The collar and cover may be integrated or separate.

A seventh version of the blood collection needle comprises a distal needle tube with a sharp needle tip, a needle hub fixed to the distal needle tube, a proximal needle tube provided proximal to the needle hub, and a protector that covers the needle tip after use. The protector houses the distal needle tube through a side opening and has a cover that covers the needle tip, a collar that is fitted over and fixed to the needle hub, and a pivoting part that rotatably connects the cover and collar. The collar is a cylindrical body with a larger outer diameter at the distal end than at the proximal end, and the pivoting part is connected to the distal end of the collar.

With this blood collection needle, the safety mechanism is provided on the needle hub rather than the blood collection tube holder, allowing the blood collection tube holder to be used multiple times, thereby reducing the amount of medical waste. Furthermore, because the pivoting part is connected to the large-diameter cylindrical part, the cover part can be positioned further outward. This reduces the chance of the blood collection tube holder and the protector interfering with each other when connecting the needle hub to the blood collection tube holder, preventing smooth operation. The collar part and the needle hub can be fixed using various methods, such as fixing by melting resin, bonding with an adhesive, or physical fitting. The pivoting part may be a hinge that connects the collar part and the cover part, or a pin that connects the collar part and the cover part. The collar part and the cover part may be integrated or separate.

An eighth aspect of the blood collection needle comprises a distal needle tube having a sharp needle tip, a needle hub fixed to the distal needle tube, a proximal needle tube provided proximal to the needle hub, and a protector that covers the needle tip after use. The needle hub has a cylindrical portion (tubular portion) extending distally and multiple ribs extending radially outward from the cylindrical portion. The protector accommodates the distal needle tube therein through a side opening and has a cover portion that covers the needle tip, a collar portion that is fitted over and fixed to the needle hub, and a rotating portion that rotatably connects the cover portion and collar portion. The collar portion has an inner protrusion that is inserted between adjacent ribs to determine its position around the axis.

With this blood collection needle, the safety mechanism is provided on the needle hub rather than the blood collection tube holder, allowing the blood collection tube holder to be reused multiple times, thereby reducing the amount of medical waste. Furthermore, the collar has an inner protrusion that is inserted between adjacent ribs to define its axial position. This allows the collar and needle hub to be roughly positioned, enabling a stable fastening process between the collar and needle hub. The collar and needle hub can be fastened using a variety of methods, including resin melting, adhesive bonding, and physical fitting. The axial position of the collar only needs to be roughly defined, and a gap may be formed between the inner protrusion and the rib. The pivoting part may be a hinge connecting the collar and cover, or a pin connecting the collar and cover. The collar and cover may be integrated or separate.

In the ninth aspect of the blood collection needle, in addition to the eighth aspect, the collar portion has a locking and fixing portion that locks with the needle hub, and is attached to the needle hub via the locking and fixing portion. The locking and fixing portion can be locked with the needle hub by bringing the collar portion and the needle hub closer together in the axial direction with the guide portion inserted between the ribs.

With this blood collection needle, the needle hub and collar are fixed by physical engagement, allowing for easy assembly without complicating the manufacturing process. Examples of the engagement and fixing portion include an inner protrusion that frictionally fits or fits concave and convexly with the outer surface of the needle hub, an inner surface of the collar that frictionally fits or fits concave and convexly with the radially outer end surface of the rib, a recess or hole formed in the collar into which the radially outward protrusion of the needle hub is inserted, or a claw formed in the collar that snaps into engagement with the flange of the needle hub. The pivoting portion may be a hinge that connects the collar and cover, or a pin that connects the collar and cover. The collar and cover may be integral or separate.

In the tenth aspect of the blood collection needle, in addition to the ninth aspect, the locking and fixing portion is formed on the inner protrusion, and is fitted with the outer surface of the needle hub, thereby assembling the collar and needle hub. With this blood collection needle, the space between the ribs on the needle hub can be effectively utilized, making it easier to miniaturize the collar. It is preferable that there are multiple inner protrusions with locking and fixing portions.

An eleventh aspect of the blood collection needle is similar to the tenth aspect, except that a plurality of inner protrusions are provided, and of the inner protrusions, a first inner protrusion and a second inner protrusion that are adjacent to each other across a rib, the first inner protrusion has a first mating protrusion that protrudes toward the second inner protrusion, and the second inner protrusion that faces the first inner protrusion across the rib has a second mating protrusion that protrudes toward the first inner protrusion, the protrusion apex of the first mating protrusion and the protrusion apex of the second mating protrusion are formed at positions offset in the needle axial direction, and the rib is press-fitted between the first and second protrusions. With this blood collection needle, a strong frictional force is generated in the direction of clamping the rib between the adjacent inner protrusions, thereby achieving strong fixation. Furthermore, because the protrusion apex of the first protrusion and the protrusion apex of the second protrusion are formed at positions offset in the axial direction, the rib can be easily press-fitted between the first and second protrusions.

With the blood collection needle disclosed herein, the safety mechanism is provided on the needle hub rather than the blood collection tube holder, allowing the blood collection tube holder to be used multiple times, thereby reducing the amount of medical waste.

FIG. 1 is a perspective view showing a blood collection needle according to one embodiment. FIG. 1 is a cross-sectional view showing a blood collection needle according to one embodiment. FIG. 3 is an enlarged cross-sectional view showing a protector portion. FIG. 10 is a front view showing the protector fixed to the needle hub. FIG. FIG. 1 is an exploded perspective view showing a blood collection needle according to one embodiment. FIG. 2 is an exploded perspective view from the bottom side showing the blood collection needle according to one embodiment. 10A and 10B are cross-sectional views showing modified examples of the small-diameter cylindrical portion. FIG. 10 is a cross-sectional view showing a state in which the needle tube is housed in the cover portion. FIG. 10 is a partially enlarged top view showing a collar portion of a blood collection needle according to a first modified example. FIG. 10 is a cross-sectional view showing a protector according to a second modified example. FIG. 10 is a partially enlarged bottom view showing a protector according to a second modified example. FIG. 10 is a partially enlarged top view showing a protector according to a second modified example. FIG. 11 is a perspective view showing a protector according to a third modified example. FIG. 11 is a perspective view showing a needle hub according to a third modified example. FIG. 10 is a perspective view showing a protector according to a fourth modified example. FIG. 10 is a perspective view showing a needle hub according to a fourth modified example. FIG. 13 is a perspective view showing a protector according to a fifth modified example. FIG. 11 is a partially enlarged cross-sectional view showing a protector according to a fifth modified example. FIG. 2 is a cross-sectional view showing the blood collection needle attached to the holder. FIG. 2 is a plan view showing the packaging state of the blood collection needle.

In order to clarify the present invention more specifically, embodiments of the present invention will be described in detail below with reference to the drawings.

1 to 7, in one embodiment of the blood collection needle 10, a protector 40 is attached to the needle hub 14 fixed to the needle tube 12, covering the needle tip 16 after use. After using the blood collection needle 10, as shown in FIG. 7, the protector 40 is rotated relative to the needle hub 14, thereby covering and protecting the needle tube 12 of the used blood collection needle 10 with the cover portion 60 of the protector 40. In the following description, the axial direction refers to the vertical direction in FIG. 2, which is the axial direction of the needle tube 12. The width direction refers to the horizontal direction in FIG. 4. The front-rear direction refers to the horizontal direction in FIG. 2, with the side where the cover portion 60 is located being the rear and the opposite side being the front. Furthermore, the tip side refers to the upper side in FIG. 2, which is the side of the needle tube 12 that punctures the skin, while the base side refers to the lower side in FIG. 2, which is the side of the needle tube 12 where the blood collection tube holder 104, described below, is attached.

More specifically, the needle tube 12 is a hollow double-ended needle, with sharp needle tips 16, 20 provided at the distal and proximal ends of the needle tube 12, respectively. Of these needle tips 16, 20, the distal needle tip 16 is the side that will be inserted into the human body, and is covered and protected by the cover portion 60 of the protector 40 after use of the blood collection needle 10. Furthermore, blade surfaces 22, 24 are formed on both needle tips 16, 20, respectively, to facilitate puncture, and both blade surfaces 22, 24 are inclined relative to the axial direction.

The needle tube 12 is fixedly supported by the needle hub 14 at its longitudinal intermediate portion or its base end side. The needle hub 14 is generally cylindrical with a central hole and can be made of, for example, a hard synthetic resin. The needle tube 12 is inserted through the central hole and adhered with an adhesive, thereby fixedly supporting the needle tube 12 to the needle hub 14. Note that while the needle tube 12 is shown as an example in which the distal and proximal ends are integrated, the distal and proximal ends can also be formed as two separate needle tubes, with each end fixed to the needle hub. Furthermore, the cutting edge at the proximal end of the needle tube 12 does not need to be formed with a sharp cutting surface.

As also shown in Figures 6 and 7, a male thread 28 is formed on the outer peripheral surface of the needle hub 14 in the longitudinal middle portion. A sleeve fixing portion 30 is formed at the base end, which first expands radially outward and then reduces in diameter. Meanwhile, the tip portion of the needle hub 14 is a cylindrical portion 32, and the outer peripheral surface of this cylindrical portion 32 is provided with multiple ribs 34 (four in this embodiment) that protrude radially outward. Furthermore, a substantially annular flange 35 that protrudes outward is provided between each rib 34 and the male thread 28, and this flange 35 protrudes further outward than each rib 34. The rib 34 is integrally connected to the tip surface of the flange 35.

A sleeve 36 is attached to the sleeve fixing portion 30 at the base end of the needle hub 14, and the base end side of the needle tube 12 is covered by the sleeve 36. The sleeve 36 is a cylindrical member with a substantially bottomed surface, and is made of an elastic material such as rubber. The base end side of the needle tube 12 is inserted into the central hole of the sleeve 36, and the tip end opening of the sleeve 36 is fixed to the sleeve fixing portion 30 of the needle hub 14, so that the sleeve 36 is attached to the needle hub 14 in a liquid-tight manner. This prevents the needle tip 20 at the base end side of the needle tube 12 from being exposed when not in use.

The needle hub 14 can also be configured with a flashback mechanism to confirm that the needle tip 16 on the patient side of the needle tube 12 has punctured a vein. The flashback mechanism is not particularly limited, but can be configured, for example, as described in Japanese Patent Application Laid-Open No. 2002-253535, in which an air passage and an air-permeable, blood-impermeable filter that connects the space covered by the sleeve 36 to the outside are provided at the base end of the transparent or translucent needle hub 14. In this case, upon puncture, air within the sleeve 36 is pushed out through the filter, while blood flows into the needle tube 12, eventually filling the space within the sleeve 36 and the air passage within the needle hub 14 and being blocked by the air-permeable, blood-impermeable filter. Flashback can be confirmed by visually inspecting the blood that has flowed into the needle hub 14 from the outside. The sleeve 36 can also be made transparent or translucent, allowing the blood that has flowed into the sleeve 36 to be visually inspected.

Here, the protector 40, which is attached to the needle hub 14 and covers the distal needle tip 16 after use, is composed of a collar portion 38, a cover portion 60, and a rotating portion that connects the cover portion 60 to the collar portion 38. The rotating portion rotates the cover portion 60 in the axial direction, displacing the cover portion 60 between a first state in which the end wall portion 74 is located closer to the base end than the rotating portion, and a second state in which the end wall portion 74 is located closer to the distal end than the rotating portion.

The collar portion 38 is a generally cylindrical member and may be formed, for example, from a hard synthetic resin. The collar portion 38 has a peripheral wall 44 with an inner cavity 42. In this embodiment, the collar portion 38 has a generally stepped cylindrical shape and includes a small-diameter cylindrical portion 46 and a large-diameter cylindrical portion 50 that protrudes toward the tip from one opening of the small-diameter cylindrical portion 46. Therefore, the inner cavity 42 of the collar portion 38 is formed by the inner cavity 42a of the small-diameter cylindrical portion 46 and the inner cavity 42b of the large-diameter cylindrical portion 50, and the peripheral wall 44 of the collar portion 38 is formed by the peripheral wall 44a of the small-diameter cylindrical portion 46 and the peripheral wall 44b of the large-diameter cylindrical portion 50. The peripheral wall 44a of the small diameter cylindrical portion 46 forms an annular portion, and its inner peripheral surface is provided with multiple inner protrusions 52 that extend radially inward and are spaced apart from one another in the circumferential direction. These can be used to roughly align the collar portion 38 (described below) with the needle hub 14.

The collar portion 38 having this shape is fixed in an externally inserted state to the needle hub 14 so that the needle hub 14 is located inside. Specifically, the needle hub 14, to which the needle tube 12 is fixed, is inserted through the opening of the collar portion 38 on the small-diameter cylindrical portion 46 side. As a result, each rib 34 of the needle hub 14 is positioned inside the small-diameter cylindrical portion 46, and the open end face of the small-diameter cylindrical portion 46 abuts against the flange 35 that protrudes radially outward beyond each rib 34. In this embodiment, each rib 34 is inserted into the inner surface of the peripheral wall 44a of the small-diameter cylindrical portion 46 with a small gap or in a zero-touch state. Each rib 34 is inserted circumferentially between inner protrusions 52 provided on the inner surface of the peripheral wall 44a, and the inner protrusions 52 can function as a guide that determines the approximate axial position of the needle hub 14 relative to the collar portion 38. Here, the axial direction refers to the direction around the needle shaft. By aligning the needle hub 14 roughly in the axial direction relative to the collar portion 38 and bringing the needle hub 14 and collar portion 38 closer together in the axial direction so that the inner protrusions 52 that make up the guide portion are inserted between adjacent ribs 34, unintended misalignment between the needle hub 14 and the collar portion 38 can be prevented during the fixing process, such as welding the needle hub 14 and the collar portion 38. This improves the stability of the fixing process. It also makes it easy to fix the positional relationship between the blade surface of the needle tube 12 fixed to the needle hub 14 and the cover portion 60 in a predetermined state.

In this embodiment, the dimensions of each rib 34 and the collar portion 38 are designed to leave a gap. Specifically, the radially outer end surface of each rib 34 is designed to frictionally engage with the inner surface of the peripheral wall 44a of the small-diameter cylindrical portion 46, while a small gap is formed between the side surface of each rib 34 and the inner protrusion 52, which serves as a guide. This configuration prevents misalignment of the needle hub and collar portion during the manufacturing process. Since a certain degree of vibration is preferable when welding using ultrasonic waves or high frequency, the collar portion 38 shown in Figure 4 has a shape suitable for ultrasonic welding or high-frequency welding. However, the inner protrusion 52, which serves as a guide, can also frictionally engage with the outer surface of the cylindrical portion 32 or the side surface of each rib 34. Providing the collar portion 38 with a configuration that frictionally engages with the needle hub 14 prevents misalignment or separation between the collar portion 38 and the needle hub 14 after the collar portion 38 is aligned with the needle hub 14 and before the components are secured together. For example, to prevent misalignment until fusion and fixation are performed, a light engagement can be used. On the other hand, if there is no process during manufacturing that involves significant movement of the collar portion 38 and needle hub 14, the collar portion 38 and inner protrusion 52 can be designed so that there is an overall gap between them and each of the ribs 34 and cylindrical portion 32.

Instead of melting and fixing by melting resin, the collar 38 can be provided with fitting portions that tightly fit with the radially outer end faces or side faces of each rib 34, thereby locking and fixing the collar 38 to the needle hub 14 with a strong fit. For example, while a configuration has been shown in which the circumferential gaps between the inner protrusions 52 are larger than the thickness of each rib 34 and there is a gap between each rib 34 and the inner protrusions 52, a configuration in which the circumferential gaps between the inner protrusions 52 are set smaller than the thickness of each rib 34 and the inner protrusions 52 sandwich the ribs 34 from both sides to provide a strong fit can also be used. Furthermore, when fixing with an adhesive rather than melting, a structure can be provided in which the collar abuts against the radially outer end faces or side faces of each rib 34.

For example, Figure 8(a) shows an example in which a protrusion 52a for clamping the rib 34 is provided on the wall surface of the inner protrusion 52 protruding from the peripheral wall 44a. The protrusion 52a can be configured to extend continuously in the axial direction of the inner protrusion 52, or can be formed along part of the axial direction. While an example is shown in which a pair of protrusions 52a that sandwich the rib 34 are aligned to face each other, they can also be positioned offset. The number of protrusions 52a provided on the opposing left and right walls can also be different. A protrusion 52a can also be provided on only one wall surface so that the rib 34 is pressed against the other wall surface. Furthermore, instead of the protrusions 52a, a configuration in which the circumferential gap of the inner protrusion 52 is approximately equal to the width of the rib 34 to clamp the rib 34 can also be used.

Figure 8(b) shows a configuration in which plate-shaped inner protrusions 53 protrude so as to form a substantially square frame inside the peripheral wall 44a, and the rib 34 is sandwiched between the inner protrusions 53. While Figure 8(b) shows an example in which the inner protrusions 53 and the rib 34 are perpendicular to each other, it is also possible for the inner protrusions 53 to abut against the rib 34 at an angle. It is also possible for the inner protrusions 53 to abut against different positions on both side surfaces of the rib 34.

In Figures 8(a) and (b), a configuration is shown in which all of the ribs 34 are clamped, but it is also possible to use a configuration in which only some of the ribs 34 are clamped. The configurations in Figures 8(a) and (b) are shown as configurations that tightly fit with the ribs 34, but by adjusting the gap, it is also possible to use a configuration that lightly engages.

In particular, in this embodiment, the collar portion 38 is integrally fixed to the needle hub 14 by resin melting. The method of resin melting between the collar portion 38 and the needle hub 14 is not limited, but ultrasonic welding, high-frequency welding, or heat welding is preferred. In this embodiment, resin is melted at the overlapping surface between the base end surface of the collar portion 38 and the tip surface of the flange 35 of the needle hub 14, and the two are integrally fixed.

In this embodiment, the small-diameter cylindrical portion 46 has an inner protrusion 52 that protrudes inward. The base end surface of the inner protrusion 52 and the base end surface of the peripheral wall 44a that forms the annular portion face the distal end surface of the flange 35 of the needle hub 14, and are fused and fixed to the needle hub 14. In particular, the inner protrusion 52 is fused and fixed to the portion between the ribs 34 of the flange 35, ensuring a large welding area. This makes it easy to ensure the welding strength and improves assembly. Note that, from the perspective of maximizing the welding area, it is preferable that both the base end surface of the inner protrusion 52 and the base end surface of the peripheral wall 44a are fused and fixed to the needle hub. However, a configuration in which the base end surface of the inner protrusion 52 is fused and fixed to the flange while the base end surface of the annular portion is not fused to the flange may also be used. In this case, if the annular portion surrounds the ribs of the needle hub, axial alignment (positioning) of the collar portion and the needle hub can be achieved. Conversely, the base end surface of the annular portion may be fused and fixed to the flange, while the base end surface of the inner protrusion 52 may not be fixed to the flange. In this case, the inner protrusion 52 located between the ribs allows for approximate alignment of the needle hub and collar. It is also possible to employ only one of the protrusion and the annular portion, and not provide the other. While this embodiment illustrates an example in which the inner protrusion 52 protrudes inward from the small-diameter cylindrical portion 46, it may also be configured to protrude outward from the small-diameter cylindrical portion 46. The annular portion may be circular or have another shape, and may be discontinuous rather than continuous. The protrusion may extend outward or inward from the annular portion, or may be an island-like portion independent of the annular portion.

In this embodiment, an example has been shown in which the inner protrusion 52 is provided over the entire axial length of the small-diameter cylindrical portion 46. In this way, the ultrasonic welding horn can be brought into contact with the peripheral wall 44a and the inner protrusion 52 from the tip side, facilitating fusion and fixation. However, the ultrasonic welding horn can also be brought into contact with the base end surface side of the flange 35. For this reason, the inner protrusion 52 can also be formed only on the base end side of the small-diameter cylindrical portion 46.

In this embodiment, each inner protrusion 52 is configured to have a cavity 55 inside. By providing the cavity 55, the molten resin can escape into the cavity 55 during melt-fixing, making it less likely for distortion or tilt to occur during melt-fixing. Furthermore, by providing the cavity 55, the inner protrusion 52 can be made to have approximately the same thickness as the other parts of the peripheral wall 44a, thereby reducing the occurrence of sink marks during molding, improving molding accuracy and stabilizing the melting process. However, the inner protrusion 52 can also be molded solid. By making the inner protrusion 52 solid, the area that is melt-fixed to the flange 35 can be further increased.

In this embodiment, the inner protrusion 52 is generally fan-shaped, with its width gradually narrowing from the peripheral wall 44a inward, but it is not limited to this shape and various shapes can be used as long as they form an opposing portion that faces the flange 35. For example, a protrusion with a constant width can be provided. Note that the inner protrusion 52 may be provided as needed, and may not be provided at all.

In this embodiment, the opposing portion that is fused and fixed to the distal end surface of the flange 35, together with the proximal end surface of the peripheral wall 44a that forms the annular portion, is an inner protrusion 52 that protrudes from the peripheral wall 44a. However, a configuration other than a protrusion that protrudes radially inward or outward from the peripheral wall 44a can also be used to increase the area of the proximal end surface of the collar portion 38, which is the opposing portion that faces the distal end surface of the flange 35. For example, a disk portion extending radially inward from the peripheral wall of the collar portion 38 can be provided, and a columnar or cylindrical portion extending from the disk portion toward the proximal end, with the base end surface of the columnar or cylindrical portion being fused and fixed to the proximal end surface of the peripheral wall 44a. The protrusion is not limited to extending radially from the peripheral wall 44a, and can also be formed as an island-like portion independent of the peripheral wall inside the peripheral wall.

In this embodiment, the base end surface of the small-diameter cylindrical portion 46 of the collar portion 38 and the tip end surface of the flange 35 are melt-fixed together. In this case, minute protrusions for melt-fixing can be provided on the base end surface of the collar portion 38 before melt-fixing. The protrusions for melt-fixing can be provided in the form of multiple dots, but can also be provided continuously across the entire base end surface of the peripheral wall 44a and the inner protrusion 52.

The collar portion 38 can also be fused and fixed to a portion other than the tip surface of the flange 35. For example, the inner peripheral surface of the base end of the small-diameter cylindrical portion 46 can be fused and fixed to the outer peripheral surface of the flange 35, or a flange can be provided at the base end of the small-diameter cylindrical portion 46 and fused and fixed to the base end surface of the flange 35. The collar portion 38 can also be fused and fixed to the rib 34 instead of the flange 35. The method of fixing the collar portion 38 to the needle hub 14 is not limited to fusion fixing, and other methods can also be used. The collar portion may have a locking and fixing portion that locks with the needle hub, and may be assembled to the needle hub via the locking and fixing portion. It is preferable that the locking and fixing portion locks with the needle hub by bringing the collar portion and needle hub closer together in the axial direction with the guide portion inserted between the ribs.

For example, the rib 34 of the needle hub 14 can be configured to tightly fit with the inner surface of the peripheral wall 44a of the small-diameter cylindrical portion 46, so that the collar portion 38 and the needle hub 14 are not fused together. Alternatively, some other structure that tightly fits with the rib 34 can be provided on the inside of the small-diameter cylindrical portion 46. For example, as shown in Figures 8(a) and (b), a structure that tightly fits can be formed by having members that clamp the rib 34 protrude from the peripheral wall 44a.

In addition to the ribs 34, various other components of the needle hub 14, such as the cylindrical portion 32, can be configured to tightly fit together. The base end of the small-diameter cylindrical portion 46 can be configured to fit over the flange 35, or a claw can be formed at the base end of the small-diameter cylindrical portion and secured by hooking onto the flange. The collar portion 38 can also have a locking and fastening portion that locks with the needle hub 14, and can be assembled to the needle hub 14 via the locking and fastening portion. The needle hub 14 and collar portion 38 can also be joined together with an adhesive, thereby securing the collar portion 38 to the needle hub 14 without integrating them by melting the resin. In this case, it is preferable that the ribs 34 and flanges 35 of the needle hub 14 be joined to the collar portion 38 with an adhesive. The needle hub 14 and collar portion 38 may be fixed together by both fitting and bonding with an adhesive; for example, the collar portion 38 may be fitted with the rib 34 of the needle hub 14, and the rib 34 of the needle hub 14 may be bonded to the flange 35 with an adhesive.

Furthermore, the collar portion 38 configured as in this embodiment does not require any special configuration on the needle hub side to secure the collar portion 38; the needle hub 14 shown in this embodiment has a general configuration with ribs and a flange. As such, in this embodiment, there is no need to prepare a needle hub with a special configuration, and it is easy to add a safety mechanism to a conventional blood collection needle without a safety mechanism to turn it into a blood collection needle with a safety mechanism. In other words, the same needle hub can be used for blood collection needles without a safety mechanism and blood collection needles with a safety mechanism and a protector, allowing for the sharing of parts.

The protector 40 has a bendable hinge portion 62 as a pivoting portion, and a cover portion 60 that covers the needle tip 16 at the distal end of the needle tube 12 and is connected to the collar portion 38 via the hinge portion 62. The protector 40 is made of synthetic resin and is formed as a single-piece molded product comprising the cover portion 60, hinge portion 62, and collar portion 38. The collar portion and cover portion can also be molded as separate parts. In this case, the pivoting portion can be a pin that pivotally connects the collar portion and cover portion. The pin is a rod-shaped portion that extends left and right from the collar portion or cover portion, and can pivotally connect the collar portion and cover portion by being accommodated in a pin housing formed in the cover portion or collar portion. The pivoting portion displaces the cover portion in the axial direction, and various configurations can be adopted.

The cover portion 60 has a longitudinal, width, and depth direction and is shaped like a longitudinal groove that accommodates the needle tube 12 with its needle axis direction aligned with the longitudinal direction. Specifically, the cover portion 60 includes a longitudinal groove bottom wall portion 66, a pair of side walls 68, 68 that protrude from both widthwise ends of the groove bottom wall portion 66 toward one side in the front-to-rear direction (depth direction in the cover portion), and a side opening 70 that faces the groove bottom wall portion 66 in the depth direction. The needle tube 12 is accommodated in the space surrounded by the groove bottom wall portion 66 and both side walls 68, 68 through the side opening 70. Furthermore, the groove of the cover portion 60 is open at an end opening portion 72 on one longitudinal side (upper side in Figure 2) and is closed at an end wall portion 74 on the other longitudinal side (lower side in Figure 2), forming a dead-end shape.

Furthermore, a needle locking portion 76 is formed within the recessed groove of the cover portion 60. This locks the needle tube 12 when it is housed in the cover portion 60, maintaining the housed state. In this embodiment, the needle locking portion 76 has an upright wall 76A that protrudes from the groove bottom wall portion 66 toward the opening side of the side opening 70, and a folded portion 76B that is folded back at the protruding tip toward the groove bottom wall portion 66. The needle tube 12 is locked by this folded portion 76B, which restricts movement of the needle tube 12 toward the side opening 70, maintaining the cover portion 60 in a housed state with the needle tube 12. The needle locking portion 76 can be formed, for example, by removing a pin from a window portion or end opening portion 72 formed in the groove bottom wall portion 66.

The needle locking portion 76 is not limited to this configuration, and can have various other configurations that can lock the needle tube 12 housed in the cover portion 60 and maintain the housed state. For example, it can be configured to protrude from the side wall portion 68 rather than rising from the groove bottom wall portion 66. Also, by not providing the needle locking portion 76 and instead using a configuration in which the side wall portion 68 and the needle hub 14 or collar portion 38 lock, the cutting edge of the needle tube can be housed within the cover portion.

Needle guides 69 protruding inward are provided on both side walls 68, 68 of the cover part 60, and a needle tube accommodating section 60a is formed, extending in a direction narrowing the opposing spacing in the width direction. The needle tube accommodating section 60a is formed to become deeper in the depth direction as the opposing spacing narrows, and has the function of accommodating the base side of the needle tube 12 on the side that will be inserted into the patient and guiding the needle tube 12 to the correct position. A needle position restricting section 77 is formed on the end wall 74 side, protruding inward from the side wall 68 on the side opposite the folded portion 76B of the needle locking section 76. The needle position restricting section 77 can restrict the position of the tip side of the needle tube 12, which is accommodated within the cover part 60 together with the needle locking section 76, so that it does not shift in the width direction.

In this embodiment, the hinge portion 62 is a spring hinge composed of multiple arms. The hinge portion 62 has a connecting arm 78 that can bend as the cover portion 60 rotates, and a biasing arm 80 that applies a biasing force to the cover portion 60 to rotate it. The connecting arms 78, 78 are formed on both the front and rear sides of the biasing arm 80. In particular, in this embodiment, the hinge portion 62 connects the large-diameter cylindrical portion 50 of the collar portion 38 to the cover portion 60, and is designed to be positioned radially outward so that the hinge portion 62 and cover portion 60 are less likely to interfere with the blood collection tube holder when the blood collection needle 10 is connected to various blood collection tube holders. This reduces the risk of unintended malfunctions caused by interference between the blood collection tube holder and the cover portion 60 when the cover portion 60 moves toward the tip due to the spring hinge.

Each connecting arm 78 has a thin-walled portion in the middle of the plate-shaped member in the longitudinal direction, allowing it to be easily bent at this thin-walled portion. Furthermore, the biasing arm 80 is given elasticity by bending or curving the plate-shaped member, and in the initial state shown in Figures 1 to 3, the cover part 60 is stabilized with the groove bottom wall part 66 and the needle tube 12 approximately parallel, as shown.

In this embodiment, the hinge portion 62 is connected to the collar portion 38 and the cover portion 60. In the first state in which the cover portion 60 remains at the base end with the distal needle tip 16 exposed, one end of the cover portion 60 is located distally of the connection between the hinge portion 62 and the collar portion 38. This shortens the axial length required to cover the needle tip 16, allowing the axial length of the cover portion 60 to be reduced. By reducing the axial length of the cover portion 60, more blood collection needles 10 can be accommodated in the package, which is economical.

In this embodiment, the base-side needle tip protection cap 86 is located closer to the base end than the other end of the cover part 60 in the first state. This allows the user to grasp the needle tip protection cap 86 rather than the cover part 60 when removing the blood collection needle 10 from the packaging, reducing the chance of grasping the cover part 60 to remove it from the packaging. If the blood collection needle 10 is grasped and removed by grasping the cover part 60, there is a risk that the hinge part 62 will be damaged if the blood collection needle 10 is unintentionally caught on something, so it is preferable that the needle tip protection cap 86 protrudes outward from the cover part 60.

When the cover part 60 is rotated from the first state around the hinge part 62 as a rotation axis, the biasing force of the biasing arm 80 displaces the cover part 60 toward the axial tip when a predetermined angle is exceeded, automatically transitioning to a second state in which the end wall part 74 remains positioned more distally than the collar part 38. Specifically, the needle tube 12 is displaced into contact with the surface of the cover part 60 on the side opening 70 side of the needle locking part 76. Even if the cover part 60 is displaced from the first state toward the axial tip, if the application of force is stopped before the predetermined angle is exceeded, the cover part 60 automatically returns to the first state. Note that the biasing force of the biasing arm 80 may be increased so that the needle tube 12 moves beyond the surface of the cover part 60 on the side opening 70 side of the needle locking part 76, and the cover part 60 covers the needle tip 16 at the tip of the needle tube 12. In this case, the state in which the cover part 60 covers the needle tip 16 of the needle tube 12 is the second state.

By pressing the groove bottom wall portion 66 from the second state, the needle tube 12 shown in FIG. 9 is housed within the cover portion 60 and locked by the needle locking portion 76, thereby transitioning to the third state. The groove bottom wall portion 66 can be pressed by pressing the groove bottom wall portion 66 against a desk or the like, so the transition from the second state to the third state can be carried out safely.

When the cover part 60 is rotated from the second state so that the end wall part 74 moves away from the needle tip 16, if the application of force is stopped before a predetermined angle is reached, it will automatically return to the second state, and if the application of force is stopped after the predetermined angle is reached, it will automatically return to the first state. Note that the predetermined angle is not particularly limited and can be set as appropriate, but from the perspective of making it less likely that unintended displacement to the second state will occur, the angle between the axis of the needle tube 12 and the axis of the cover part 60 can be set to, for example, approximately 90°.

As shown in Figure 5, in the first state in which the cover portion 60 is displaced toward the base end, it is preferable that the needle locking portion 76 be located axially between the needle position restricting portion 77 and the collar portion 38. By arranging it in this manner, when molding the protector 40, the collar portion 38, which is the main component, and the cover portion 60 having the needle locking portion 76 and needle position restricting portion 77 that regulate the position of the needle tube 12 can be molded without using a complex mold. Because the mold is not complex, the risk of reduced operational stability and the production of defective products is reduced, and quality can be improved. However, in the first state, the needle locking portion 76 can also be positioned so that it overlaps with the collar portion 38 in the axial direction. The position of the needle locking portion 76 can also be freely set independent of the collar portion 38.

In this embodiment, the outer diameter of the small-diameter cylindrical portion 46 of the collar portion 38 is approximately equal to the outer diameter of the flange 35 of the needle hub 14, and a large-diameter cylindrical portion 50 with a larger diameter than the small-diameter cylindrical portion 46 is provided at the tip end. The large-diameter cylindrical portion 50 allows the hinge portion 62 to be fixed radially outward, allowing the cover portion 60 to be positioned radially outward without increasing the length of the hinge portion 62. This ensures the strength of the hinge portion 62 while making it less likely that unintended interference will occur between the cover portion 60 and various blood collection tube holders. However, the collar portion 38 is not limited to a configuration having a small-diameter cylindrical portion 46 and a large-diameter cylindrical portion 50, and can also be a cylindrical portion of the same diameter overall.

The axial dimension of the collar portion 38 is designed so that the large-diameter cylindrical portion 50 is longer than the small-diameter cylindrical portion 46, and the hinge portion 62 is positioned closer to the tip. This reduces unintended interference between the hinge portion 62 and cover portion 60 and various blood collection tube holders, and also reduces the axial dimension of the cover portion 60 that covers the needle tube 12, thereby reducing the size required for packaging.

The distal end of the collar portion 38 is preferably located closer to the distal end than the distal end of the needle hub 14. Furthermore, the hinge portion 62 is preferably connected to the distal end of the collar portion 38. In this way, the connection position of the hinge portion 62 with the collar portion 38 can be located closer to the distal end than the needle hub 14, making it less likely that the hinge portion 62 or cover portion 60 will interfere with various blood collection tube holders, and also reducing the axial dimension of the cover portion 60 that covers the needle tube 12, thereby reducing the size required for packaging.

The axial length of the small-diameter cylindrical portion 46 is preferably longer than the axial length of the rib 34 of the needle hub 14. This allows the ultrasonic welding horn inserted from the tip side to easily abut against the tip surface of the peripheral wall 44a of the small-diameter cylindrical portion 46, making it easier to fuse and fix the collar portion 38 and the needle hub 14 together.

The relative circumferential position of the cover portion 60 with respect to the blade surface 22 is not limited, but in this embodiment, when the needle tube 12 is housed within the cover portion 60, the blade surface 22 faces the groove bottom wall portion 66.

Furthermore, as shown in Figures 1 to 3, in the initial state before use, needle tip protection caps 84, 86 are provided to cover the needle tips 16, 20 on both sides of the needle tube 12, and in this embodiment, both the distal needle tip protection cap 84 and the proximal needle tip protection cap 86 are removably attached to the collar portion 38. In other words, the needle tip protection caps 84, 86 are removably attached to both axial ends of the collar portion 38.

The tip protection cap 84 on the distal end side is tubular in shape, with a generally closed bottom, and opens to the proximal end, extending in the axial direction. The tip portion of the needle tip protection cap 84 is tapered, with the outer diameter gradually decreasing toward the tip, and the axially intermediate portion has a seal attachment portion 88 that extends axially with a generally constant outer diameter and to which a confirmation seal 100, described below, is affixed. The outer diameter of this seal attachment portion 88 is generally equal to the outer diameter of the large-diameter tubular portion 50 of the collar portion 38.

The base end portion of the needle tip protection cap 84 is smaller than the outer diameter of the seal attachment portion 88, and the outer diameter of the base end portion of the needle tip protection cap 84 is approximately equal to or slightly larger than the inner diameter of the large diameter cylindrical portion 50 of the collar portion 38. This allows the needle tip protection cap 84 to be removably attached by inserting the base end portion into the large diameter cylindrical portion 50 and press-fitting it into the large diameter cylindrical portion 50, and the base end portion of the needle tip protection cap 84 forms an insertion fixing portion 90 that is inserted into and fixed in the large diameter cylindrical portion 50. This allows the opening of the base end portion of the needle tip protection cap 84 to be larger, reducing the risk of the needle tip 16 on the distal end side of the needle tube 12 hitting the needle tip protection cap 84 when assembling the needle tip protection cap 84 and damaging the cutting edge.

Furthermore, a protrusion 92 that protrudes toward the base end is provided on the base end surface of the seal attachment portion 88, i.e., on the outer periphery of the insertion fixing portion 90. This protrusion 92 has a certain protruding height and is provided partially on the circumference. As a result, when the distal needle tip protection cap 84 is fitted into the large diameter cylindrical portion 50 of the collar portion 38, the protruding distal end surface of each protrusion 92 abuts against the distal end surface of the large diameter cylindrical portion 50.

The axial length of the inner fixing portion 90 is shorter than the axial length of the large diameter cylindrical portion 50 located on the outer periphery, and a region of the large diameter cylindrical portion 50 with a certain axial length that does not extend from the tip to the base end serves as a cylindrical cap fitting portion 94 that fits into the inner fixing portion 90.

Similarly, the proximal needle tip protection cap 86 is shaped like a cylinder with a generally closed bottom that opens toward the distal end, with the proximal portion being a tapered cylinder whose outer diameter gradually decreases toward the proximal end. Furthermore, the distal end of the needle tip protection cap 86 is formed with a seal attachment section 96 that extends axially with a generally constant outer diameter and to which a confirmation seal 100 (described below) is attached.

The inner diameter of this seal affixing portion 96 is approximately equal to or slightly smaller than the outer diameter of the small-diameter cylindrical portion 46 of the collar portion 38. As a result, the needle tip protection cap 86 can be removably attached by inserting the seal affixing portion 96, which is its tip portion, onto the small-diameter cylindrical portion 46 and press-fitting it into the small-diameter cylindrical portion 46. The seal affixing portion 96, which is the tip portion of the needle tip protection cap 86, also functions as an extrapolated fixing portion that is extrapolated onto and fixed to the small-diameter cylindrical portion 46. As a result, when the base-side needle tip protection cap 86 is fitted onto the small-diameter cylindrical portion 46 of the collar portion 38, the tip surface of the convex portion 54 provided on the tip-side end surface of the seal affixing portion 96 abuts against the step portion 48 created between the small-diameter cylindrical portion 46 and the large-diameter cylindrical portion 50 of the collar portion 38. Additionally, the inner peripheral surface of the seal affixing portion (externally inserted and fixed portion) 96 is provided with a plurality of axially extending ribs 97 spaced apart in the circumferential direction, so that when the small diameter cylindrical portion 46 and the seal affixing portion (externally inserted and fixed portion) 96 are fitted together, a slight radial gap is provided between the outer peripheral surface of the small diameter cylindrical portion 46 and the inner peripheral surface of the seal affixing portion (externally inserted and fixed portion) 96.

In this way, the needle tip protection caps 84, 86 are fitted and attached to the cap fitting portions 94, 98 on both axial sides of the collar portion 38, respectively, so that the outer surfaces of the needle tip protection cap 84, the collar portion 38, and the needle tip protection cap 86 are positioned on approximately the same circumferential surface, and a confirmation seal 100 is affixed across the outer surfaces of the needle tip protection cap 84, the collar portion 38, and the needle tip protection cap 86.

Furthermore, in this embodiment, the confirmation seal 100 is provided with perforated slits 102a and 102b so that the confirmation seal 100 can be easily torn when the needle tip protection caps 84 and 86 are removed from the collar portion 38. The confirmation seal 100 may be provided as needed, or may not be provided at all.

Furthermore, in this embodiment, the removal resistance of the needle tip protection cap 84, which protects the needle tip (distal needle tip 16) on the puncture side of the needle tube 12, is set to be greater than the removal resistance of the needle tip protection cap 86, which protects the needle tip (proximal needle tip 20) on the opposite side of the blood collection tube (not shown) (or the blood collection tube holder 104 described below). These removal resistances can be set based on the fitting force between the internal fixing portion 90 and the cap fitting portion 94, the fitting force between the external fixing portion (seal attachment portion 96) and the cap fitting portion 98, the ease of breaking each of the slits 102a, 102b in the confirmation seal 100, etc. Furthermore, the removal resistance force of the distal needle tip protection cap 84 is set to be greater than the removal resistance force of the proximal needle tip protection cap 86. Therefore, for example, when using the blood collection needle 10, by grasping both needle tip protection caps 84, 86 with one finger and pulling them out in the axial direction, the proximal needle tip protection cap 86 can be removed before the distal needle tip protection cap 84, without having to worry about which one to remove first.

As in the collar portion 38A of the blood collection needle of the first modified example shown in Figure 10, an inner fitting cylinder 56 that fits into the needle tip protection cap 84 can be provided inside the large diameter cylindrical portion 50 to make the removal resistance of the needle tip protection cap 84 on the distal end greater than the removal resistance of the needle tip protection cap 86 on the proximal end. The inner fitting cylinder 56 can not only fit into the needle tip protection cap 84, but can also be configured so that the outer surface of the inner fitting cylinder 56 and the inner surface of the peripheral wall 44b of the large diameter cylindrical portion 50A press against the insertion fixing portion 90 of the needle tip protection cap 84.

10, the collar portion 38A has a cap holding portion that detachably engages with the needle tip protection cap 84, and the cap holding portion is formed with a rotation suppressing portion that creates resistance to relative circumferential rotation between the collar portion 38A and the needle tip protection cap. Specifically, a rib 58 is provided on the outer surface of the inner fitting tube 56. The rib 58 and the inner surface of the needle tip protection cap 84 abut to generate axial friction. In addition, a rib 93 is provided on the inner surface of the needle tip protection cap 84. When an attempt is made to rotate the needle tip protection cap 84 relative to the collar portion 38 in the circumferential direction, the rib 58 abuts the rib 93, suppressing relative rotation of the needle tip protection cap 84 with respect to the collar portion 38A. Because the collar portion 38A is provided with such a rotation suppressing portion, it is easy to grip and operate the tip-side needle tip protection cap 84 when threading the male thread 28 of the needle hub 14 into the blood collection tube holder 104 described later. The rotation suppression section may be realized by a concave-convex structure between the needle tip protection cap 84 and the collar section, or by attaching a separate sticker, etc. The rib 58 may be provided as needed, or may not be provided at all.

In this modified example, the inner fitting cylinder 56 is arranged to protrude toward the tip side from a disk-shaped partition wall 47 formed radially inward at the tip of the small-diameter cylindrical portion. This configuration makes it easy to form the inner fitting cylinder 56. The inner fitting cylinder 56 is formed inside the large-diameter cylindrical portion 50A, and the needle tip protection cap 84 abuts against the large-diameter cylindrical portion 50A and the inner fitting cylinder 56, and is fixed separably to the collar portion.

Figures 11 to 13 show a protector 40B used with a blood collection needle according to the second modified example. The protector 40B has a collar portion 38B and a cover portion 60 similar to those in the previously described embodiment and first modified example. The small-diameter cylindrical portion 46B of the collar portion 38B has an inner protrusion 52 located between adjacent ribs 34 on the needle hub 14. The inner protrusion 52 is adjacent to the rib 34 and engages with the needle hub 14. Specifically, the wall surface of the inner protrusion 52 has an engaging protrusion 122 that forms the engaging and fixing portion. In this modified example, the engaging protrusion 122 has an arc-shaped cross section and protrudes from the wall surface of the inner protrusion 52, extending axially. The mating protrusion 122 has a tapered surface extending from the base end toward the tip end, away from the wall surface of the inner protrusion 52. When the needle hub 14 is inserted from the base end of the small-diameter cylindrical portion 46B, the deeper the insertion, the stronger the contact between the wall surface of the rib 34 of the needle hub 14 and the mating protrusion 122. By inserting the inner protrusion 52 between adjacent ribs 34 and bringing the collar portion 38B and the needle hub 14 closer to each other in the axial direction, the collar portion 38B and the needle hub 14 are fixed to each other via the locking and fixing portion. In the second modified example, the collar portion 38B and the needle hub 14 can be fixed to each other by physical locking rather than by resin fusion or adhesive. Fixing the collar portion and the needle hub to each other by physical locking simplifies the manufacturing process. However, it is also possible to fix the collar portion 38B and the needle hub 14 of the second modified example to each other by resin welding or adhesive, or by combining physical locking and adhesion.

The mating protrusions 122 have a tapered surface that extends from the base end toward the tip end, away from the wall surface of the inner protrusion 52, making it easier to insert the needle hub 14 into the small-diameter cylindrical portion 46B, and by inserting it all the way, it is less likely to become misaligned. However, the mating protrusions 122 are not limited to this shape; for example, they may be shaped without a tapered surface. The position, size, and number of the mating protrusions 122 can also be adjusted. For example, while the example shown has mating protrusions 122 on all four surfaces of the inner protrusion 52 that face the ribs 34 of the needle hub 14, it is also possible for there to be surfaces on which mating protrusions 122 are not formed. Furthermore, the mating protrusions 122 do not have to be continuous in the axial direction, and can be formed only in a portion of the axial direction. It is also possible to have no mating protrusions 122 and have the inner protrusion 52 engage with the ribs 34 at their surfaces. Also, instead of one inner protrusion 52 contacting both adjacent ribs 34, two inner protrusions may be present in the space between adjacent ribs 34, and the two inner protrusions may abut against each rib 34. Alternatively, the inner protrusions may not contact the ribs 34, but may contact and fit with the cylindrical portion 32 of the needle hub 14.

In the second variant, the small-diameter cylindrical portion 46B has a notch 123 cut out from a portion of its base end. When fixing the collar portion 38B to the needle hub 14, a jig can be inserted into the gap created by the notch 123 to align the circumferential positions of the collar portion 38B and the needle hub 14, or the jig can be used to grasp and transport the needle hub 14. The notch 123 can also be used as a marker for aligning the axial positions of the collar portion 38B and the needle hub 14. Furthermore, the notch 123 serves as a gas passage during gas sterilization, thereby providing the advantage of facilitating gas sterilization. The notch 123 can also be provided in the previously described embodiment and the first variant. In this case, the flange 35 of the needle hub 14 can have an oval shape with a linear portion cut out from a circular periphery. The collar portion 38B and the needle hub 14 can be fixed by positioning the notch 123 of the small-diameter cylindrical portion 46B in the linear portion of the flange 35. This arrangement ensures a sufficient contact area between the base end surface of the small-diameter cylindrical portion 46B and the distal end surface of the flange 35, even with the provision of the notch 123. When the collar portion 38B and the needle hub 14 are fixed by welding or the like, the melting area can be increased, improving manufacturability while preventing a decrease in the fixing strength between the collar portion 38B and the needle hub 14. Furthermore, in the previously described embodiment and this modified example, the flange 35 and rib 34 of the needle hub 14, and the inward protrusion 52 and notch 123 of the small-diameter cylindrical portion 46B automatically position the notch 123 in the linear portion of the flange 35. This allows for efficient assembly.

In this modified example, the large-diameter cylindrical portion 50B, like the large-diameter cylindrical portion 50A of the first modified example shown above, has an inner fitting cylinder 56 that fits into the needle tip protection cap 84, a rib 58 for preventing rotation of the needle tip protection cap 84, and a partition wall 47 between it and the small-diameter cylindrical portion 46B. The large-diameter cylindrical portion 50B also has a gas-venting rib 125 on its inner surface. The provision of the rib 125 ensures a gas passage even when the inner insertion fixing portion 90 of the needle tip protection cap 84 is fitted into the large-diameter cylindrical portion 50B, facilitating gas sterilization. While an example is shown in which three gas-venting ribs 125 are provided at equal intervals, the number of ribs 125 is not particularly limited. Providing multiple ribs 125 at equal intervals can increase the effect of uniformly distributing gas. A gas passage can also be ensured by methods other than the rib 125.

In this modified example, the partition wall 47 has a recess or through-hole 124. The recess or through-hole 124 is formed in a position corresponding to the inner protrusion 52 on the small-diameter cylindrical portion 46B side. By providing the recess or through-hole 124, the molding precision of the inner protrusion 52 can be improved. Furthermore, in the case of a through-hole, it also functions as a gas passage during gas sterilization.

Below, a specific example of a method for assembling the blood collection needle 10 of this embodiment will be described. Note that the method for assembling the blood collection needle 10 is not limited to the following description.

First, the needle tube 12 is inserted into the needle hub 14, and the needle tube 12 and needle hub 14 are bonded together with adhesive. Then, a sleeve 36 is attached to the sleeve fixing portion 30 of the needle hub 14 so as to cover the needle tip 20 on the base end side of the needle tube 12. Then, the collar portion 38 is inserted from the tip side onto the needle hub 14 to which the needle tube 12 is attached, and the needle hub 14 and the small-diameter tube portion 46 of the collar portion 38 are fixed by ultrasonic welding. Then, silicone oil, which acts as a lubricant when puncturing the human body, is applied to the outer surface of the portion of the needle tube 12 protruding from the needle hub 14. Then, the tip-side and base-side needle tip protection caps 84, 86 are fitted and attached to the large-diameter tube portion 50 and small-diameter tube portion 46 of the collar portion 38, respectively. Then, a confirmation sticker 100 is affixed across the needle tip protection cap 84, collar portion 38, and needle tip protection cap 86. This completes the assembly of the blood collection needle 10 in embodiment 1.

The assembled blood collection needle 10 is sterilized, for example, with a sterilizing gas. That is, the blood collection needle 10 is placed inside a sealable container or the like and filled with sterilizing gas. As a result, sterilizing gas fills the interior of the blood collection needle 10 closer to the distal end than the needle hub 14 through the circumferential gaps between the protrusions 92 on the distal needle tip protection cap 84 and the radial gap between the large-diameter cylindrical portion 50 and the inner fixing portion 90, thereby carrying out sterilization. Sterilizing gas also fills the interior of the blood collection needle 10 closer to the proximal end than the needle hub 14 through the circumferential gaps between the protrusions 54 on the distal end surface of the seal affixing portion 96 and the radial gap between the small-diameter cylindrical portion 46 and the seal affixing portion (external fixing portion) 96, thereby carrying out sterilization. The blood collection needle 10 is then individually packaged, for example, and prepared for shipment. Modified blood collection needles can also be assembled in a similar manner.

When the collar portion and needle hub are fixed via a locking and fixing portion, a configuration like the third modified example shown in Figures 14 and 15 can also be used. The collar portion 38C of the protector 40C has a locking protrusion 161 that forms a locking and fixing portion radially inward of the inner protrusion 151, and the needle hub 14A has a return stop portion 162 that restricts movement of the locking protrusion 161 toward the tip.

The collar portion 38C has an inner protrusion 151 that protrudes radially inward from the peripheral wall 44. The inner protrusion 151 is inserted between the ribs 34 provided on the needle hub 14A. The inner protrusion 151 protrudes from the peripheral wall 44 and has two side surfaces 152 that extend approximately parallel to the ribs 34, and an end surface 153 that connects the two side surfaces 152 at a position toward the center, forming a roughly V-shape in plan view. The locking protrusion 161 is a convex portion provided on the end surface 153 that protrudes radially inward.

The detent portion 162 is a convex portion that protrudes radially and circumferentially from the outer surface of the cylindrical portion 32A, and extends circumferentially between the ribs 34 on the tubular portion of the needle hub. The diameter of the imaginary circle at the center surrounded by the end face 153 of the inner protrusion 151 is set to be approximately equal to or slightly larger than the outer diameter of the cylindrical portion 32A of the needle hub 14A. Therefore, when the collar portion 38C is inserted onto the needle hub 14A, the locking projection 161 abuts against the outer surface of the cylindrical portion 32A at a position where it overcomes the detent portion 162, and the collar portion 38C is locked and fixed to the needle hub 14A.

The tip side of the locking projection 161 forms a step that rises almost perpendicularly from the end face 153, and the base end side forms an inclined surface. The tip and base end sides of the detent portion 162 also form inclined surfaces. By providing an inclined surface on the tip side of the detent portion 162 or the base end side of the locking projection 161, the locking projection 161 can easily climb over the detent portion 162 from the tip side to the base end side. Even if a force is applied in a direction that would separate the collar portion 38C and needle hub 14A from their assembled state, the locking projection 161 and the detent portion 162 abut against each other, preventing them from easily separating. In this way, the needle hub 14A and collar portion 38C are locked together by the concave-convex fit of the locking projection 161 and the detent portion 162. The shapes of the base end side of the detent portion 162 and the tip side of the locking projection 161 can be adjusted as needed depending on the desired fixation strength.

In this modified example, the end face 153 of the inner protrusion 151 has a chamfered portion 171 that flares outward in the radial direction, closer to the base end than the locking projection 161, and the gap between the end face 153 and the cylindrical portion 32A gradually increases at the lower end of the collar portion 38C. This makes it easier to insert the cylindrical portion 32A into the space surrounded by the inner protrusion 151. However, a configuration without the chamfered portion 171 is also possible.

In this modified example, the inner protrusion 151 is formed in a roughly V-shape in plan view. This makes it easy to ensure the strength of the inner protrusion 151. Furthermore, by reducing the gap with the rib 34, it is possible to make it less likely for the needle hub 14A to shift in the circumferential direction. Note that if the inner protrusion 151 is roughly V-shaped, a hollow portion 172 can be formed inside, making it easier to mold the collar portion 38C. However, various shapes can be selected for the inner protrusion 151. For example, it can be a flat plate that protrudes from the peripheral wall 44 toward the center. It can also be configured so that it is not connected to the peripheral wall 44, but extends toward the base end from the partition between the large-diameter cylindrical portion and the small-diameter cylindrical portion.

In this modified example, the peripheral wall 44 of the collar 38C has a notch 123 at its base end. The flange 35 of the needle hub 14A has an oval shape with a circular periphery cut out to create a straight section. The collar 38C and needle hub 14A are fixed together with the notch 123 in the peripheral wall 44 positioned on the straight section of the flange 35. By clamping the straight section of the flange 35 in a jig and inserting the needle hub 14A into the collar 38C so that the tip of the jig fits into the notch 123, the inner protrusion 151 and the rib 34 can be aligned while the necessary force for engagement can be applied. This allows the collar 38C and needle hub 14A to be efficiently fitted and secured together using automated assembly equipment. However, a configuration without the notch 123 is also possible.

In this modified example, an example in which there are four ribs and four inner protrusions is shown, but the number of ribs and inner protrusions can be selected as appropriate. The number of inner protrusions can also be less than the number of ribs. For example, a cylindrical portion provided with four ribs can be configured to fit with two inner protrusions.

When the collar and needle hub are secured via a locking and fastening portion provided on the inner protrusion, the locking and fastening portion is not limited to the outer surface of the cylindrical portion 32, but can be configured to fit with various parts of the outer surface of the needle hub. The outer surface of the needle hub refers to the surface of the part of the needle hub 14 that is housed inside the collar, including the outer surface of the cylindrical portion 32 of the needle hub 14 and the side and radial outer end surfaces of the ribs 34. The locking and fastening portion is not limited to the inner protrusion, but can also be the inner surface of the collar that frictionally fits or fits concave and convexly with the radial outer end surface of the rib, a recess or hole formed in the collar into which the radial outer protrusion of the needle hub is inserted, a claw formed in the collar that snaps into engagement with the flange of the needle hub, etc.

For example, the locking and fixing portion can be configured as in the fourth modified example shown in Figures 16 and 17. The collar portion 38D of the protector 40D has a first mating protrusion 163, and the needle hub 14B has a mated portion 164 that mates with the first mating protrusion 163. The collar portion 38D has a first inner protrusion 155A and a second inner protrusion 155B as inner protrusions 155 that protrude radially inward from the peripheral wall 44. The first inner protrusion 155A has two side surfaces 156A protruding from the peripheral wall 44 and an end surface 157A connecting the two side surfaces 156A at a position closer to the center, forming a roughly V-shape in plan view. The second inner protrusion 155B has two side surfaces 156B protruding from the peripheral wall 44 and an end surface 157B connecting the two side surfaces 156B at a position closer to the center, forming a roughly V-shape in plan view. The first inner protrusions 155A and the second inner protrusions 155B are arranged alternately in the circumferential direction, and a gap 173 is formed between adjacent first inner protrusions 155A and second inner protrusions 155B.

First mating protrusions 163 are provided on the two side surfaces 156A of the first inner protrusion 155A. The first mating protrusions 163 are protrusions that protrude toward the side surface 156B of the opposing second inner protrusion 155B, and are formed on the side surface 156A. Second mating protrusions 165 are provided on the two side surfaces 156B of the second inner protrusion 155B. The second mating protrusions 165 are protrusions that protrude toward the side surface 156A of the opposing first inner protrusion 155A, and extend in the axial direction. The second mating protrusions 165 have approximately the same shape as the mating protrusions 122.

The mating portion 164 is a convex portion provided on the surface of the rib 34B that faces the first mating convex portion 163. In this modified example, the surface of the rib 34B opposite the mating portion 164 is a pressed portion 166 that is pressed by the second mating convex portion 165, which is a flat surface, and faces the second mating convex portion 165.

The rib 34B on the needle hub 14B is inserted into the gap between the adjacent first inner protrusion 155A and second inner protrusion 155B. In this modified example, four gaps 173 and four ribs 34B are provided. In this case, the collar portion 38D and the needle hub 14B are aligned so that the rib designated by the reference symbol 34B in FIG. 17 is inserted into the gap designated by the reference symbol 173 in FIG. 16, and the collar portion 38D and the needle hub 14B are brought closer together in the axial direction. In this way, the first mating protrusion 163 on the first inner protrusion 155A and the mated portion 164 on the rib 34B face each other and fit together. The collar portion 38D and the needle hub 14B can also be mated when positioned 180° offset around the axis.

At the base end of the collar portion 38D, the gap 173 between the side surface 156A of the first inner protrusion 155A and the side surface 156B of the second inner protrusion 155B is set slightly larger than the thickness of the rib 34B. More specifically, the protrusion apex of the first mating convex portion (the point on the first mating convex portion closest to the side surface 156B of the second inner protrusion 155B) is formed at a position offset in the axial direction from the protrusion apex of the second mating convex portion 165 (the point on the second mating convex portion closest to the side surface 156A of the first inner protrusion 155A). Therefore, when the rib 34A is inserted into the gap 173 from the base end side, the second mating convex portion 165 on the second inner protrusion 155B presses the pressed portion 166, causing the rib 34B to gradually tilt toward the first inner protrusion 155A. As a result, the mating portion 164 of the rib 34B and the first mating protrusion 163 of the first inner protrusion 155A approach each other, and a strong frictional force is generated in the direction of clamping the rib 34B between the first mating protrusion 163 and the second mating protrusion 165. This results in a secure mating between the first mating protrusion 163 and the mating portion 164. Furthermore, because the apexes of the first mating protrusion 163 and the second mating protrusion 165 are offset in the axial direction, this also has the effect of making it easier to press-fit the rib 34B between the first mating protrusion 163 and the second mating protrusion 165. This makes it easier to insert the rib 34B between the first inner protrusion 155A and the second inner protrusion 155B, and to achieve a secure mating state.

In this modified example, the second mating protrusion 165 is shaped so that the large-diameter side of the halved truncated cone is positioned on the partition wall side between the small-diameter cylindrical portion and the large-diameter cylindrical portion, and therefore the axial position of the apex of the protrusion of the second mating protrusion 165 is at the very tip of the small-diameter portion. However, the axial position of the apex of the protrusion of the second mating protrusion 165 does not have to be at the very tip of the small-diameter portion. It is also possible to configure the axial positions of the apexes of the protrusions of the first mating protrusion 163 and the second mating protrusion 165 to be the same. The second mating protrusion 165 can also be shaped so that the protrusion height toward the first inner protrusion 155A is constant.

The tip side of the first mating convex portion 163 forms a step that rises almost perpendicularly from the side surface 156A, and the base end side forms an inclined surface. The tip and base end sides of the mated portion 164 form inclined surfaces, with the base end side being steeper. The first mating convex portion 163 can easily climb over the mated portion 164 from the tip end side to the base end side, but it is difficult to climb over it from the base end side to the tip end side. As a result, the collar portion 38D and needle hub 14B are easily engaged with each other, and the engaged state is difficult to release.

Making the base end side of the mating portion 164 an inclined surface rather than a step makes it easier to design the mold for forming the needle hub 14B. However, it is also possible to make the base end side of the mating portion 164 a step, or to make it an inclined surface that becomes steeper toward the base end and therefore more difficult to overcome. In this way, it is possible to make it more difficult for the first mating convex portion 163 to move toward the tip end.

In this modified example, a notch 174 is provided on the side surface 156A in a portion closer to the tip than the first mating protrusion 163. This configuration makes it easy to form a sharp-edged step on the tip side of the first mating protrusion 163. However, the notch 174 does not have to be provided.

A mating portion of a different configuration can also be mated with the mated portion 164. The collar portion 38E of the fifth modified example shown in Figures 18 and 19 has a first mating protrusion 163A that can be mated with the needle hub 14B of the fourth modified example shown in Figure 17. In the fifth modified example, too, the needle hub 14B and the collar portion 38E can be aligned so that the rib labeled 34B in Figure 17 of the needle hub 14B is inserted into the gap labeled 173 in Figure 18, and the needle hub 14B and the collar portion 38E are brought closer together in the axial direction, thereby mating the first mating protrusion 163A with the mated portion 164.

The first mating protrusion 163A has a first sloping surface 167 that gradually increases in height from the base end toward the tip end, and a second sloping surface 168 that is more gently inclined than the first sloping surface 167. A notch 174 is provided on the tip end side of the first mating protrusion 163A on the side surface 156A. This allows the first mating protrusion 163A to deform appropriately when the rib 34B is inserted into the gap 173. Unlike the first mating protrusion 163, the tip end side of the first mating protrusion 163A is not an upright surface but rather a slope that slopes diagonally downward.

In the fourth and fifth modified examples, the shape of the inner protrusion can be various shapes, just like in the third modified example. In the fourth and fifth modified examples, the peripheral wall 44 of the collar portion 38D also has a notch 123 at its base end. This improves assembly efficiency, just like in the third modified example.

In the fifth modified example, the notch 123 is offset approximately 90° circumferentially from the connecting arm 78. By offsetting the positions of the notch 123 and the connecting arm 78, chucking during assembly becomes easier. However, the notch 123 may also be aligned with the connecting arm 78. Furthermore, the positions of the notch 123 and the connecting arm 78 can also be offset in other embodiments and modified examples.

In the fourth and fifth modified examples, the second inner protrusion 155B is positioned so that it is in the position of the notch 123. The second inner protrusion 155B, which is provided with the second fitting convex portion 165, is provided at the position of the notch 123. However, the first inner protrusion 155A can also be positioned at the position of the notch 123, or the notch 123 can be overlapped by part of the first inner protrusion 155A and the second inner protrusion 155B.

In the fourth and fifth modified examples, the first mating protrusions 163, 163A are provided on two side surfaces of the first inner protrusion 155A, and the second mating protrusions 165 are provided on two side surfaces of the second inner protrusion 155B. This configuration simplifies mold design and improves productivity. However, it is also possible to have a configuration in which the first mating protrusion is provided on one side surface of the inner protrusion and the second mating protrusion is provided on the other surface. Also, while the configuration in which the second mating protrusion is provided on the inner protrusion side and the mated portion is tilted toward the first mating protrusion side has been shown, it is also possible to provide a protrusion on the surface of the rib opposite the mated portion so that the mated portion is tilted toward the first mating protrusion side.

In the fourth and fifth variants, there are four ribs and four first mating protrusions, but the number of ribs can be changed and the number of mating protrusions can be set to match the number of ribs. Also, while all of the ribs are configured to mating with the first mating protrusions, it is also possible to configure only some of the ribs to mating with the first mating protrusions.

Even in the configuration shown in Figures 8(a) and (b), it is possible to provide a mating portion on the protrusion and a mated portion on the rib, so that the mating portion fits over the mated portion.

The collar can also be configured to fit into a flange on the needle hub. For example, a hook claw that engages with the base end side of the flange can be provided at the base end of the collar, allowing the collar and needle hub to fit together so that they do not come off. Alternatively, a mating convex portion provided at the base end of the collar can be inserted into a mating hole provided in the flange for mating. A recess can also be provided in the collar and a convex portion on the flange. A configuration in which the outer peripheral surface of the flange fits into the inner peripheral surface of the collar, or a claw or the like provided on the flange can fit into the outer peripheral surface of the collar, is also possible.

In various modified examples of fitting and fixing the collar portion and needle hub, the configuration of the protector excluding the collar portion, the configuration of the needle hub excluding the cylindrical portion and rib, and the configuration of the needle tip protection cap can be the same as in the previously shown embodiment and other modified examples. Various other configurations can also be adopted.

Below, a specific example of how to use the blood collection needle 10 of this embodiment will be described. Note that the method of using the blood collection needle 10 is not limited to the following description.

The packaged blood collection needle 10 is removed, and the needle tip protection caps 84, 86 on both axial sides are grasped with one finger each, and pulled in the direction (axial direction) so that the distal needle tip protection cap 84 and the proximal needle tip protection cap 86 move away from each other. In this embodiment and its modified examples, the removal resistance of the distal needle tip protection cap 84 is greater than the removal resistance of the proximal needle tip protection cap 86, so the distal needle tip protection cap 84 remains held by the collar portion 38, and the proximal needle tip protection cap 86 is removed. The proximal end of the needle tube 12 from which the needle tip protection cap 86 has been removed is then connected to, for example, a blood collection tube holder 104 as shown in Figure 20.

The specific structure of the blood collection tube holder 104 is not limited, but the blood collection tube holder 104 shown in Figure 20 is cylindrical overall and consists of a main body 106 and a holding part 108 that is inserted from the base end of the main body 106. There are various types of blood collection tube holders, and some types have a pressure plate that protrudes laterally from the tip side of the blood collection tube holder.

The main body 106 comprises an annular bottom wall 112 that extends perpendicular to the axis and has a through-hole 110 in the center, and a generally tapered cylindrical peripheral wall 114 that extends from the outer periphery of the bottom wall 112 toward the base end. The periphery of the through-hole 110 in the bottom wall 112 is provided with an outer circumferential cylindrical portion 116 and an inner circumferential cylindrical portion 118 that protrude toward the tip end, and the inner circumferential surface of the inner circumferential cylindrical portion 118 is formed with a female thread that corresponds to the male thread 28 of the needle hub 14.

The needle tip 20 on the base end side of the needle tube 12, covered by the sleeve 36, is inserted into the blood collection tube holder 104 through the through-hole 110, and the male thread 28 on the needle hub 14 and the female thread on the inner cylindrical portion 118 are threaded together to connect the blood collection tube holder 104 to the base end side of the needle tube 12. When the blood collection tube holder 104 is connected in this manner, the small-diameter cylindrical portion 46 of the collar portion 38 is pressed from the outer periphery by the tip portion of the outer cylindrical portion 116.

From this state, the tip-side needle tip protection cap 84 is pulled axially and removed, exposing the tip-side needle tip 16 of the needle tube 12. Then, the tip-side of the needle tube 12 (blood collection needle 10) is inserted into the body, and a blood collection tube (not shown) is inserted into the blood collection tube holder 104. The needle tip 20 at the base end of the needle tube 12 penetrates the sleeve 36 and communicates with the blood collection tube, thereby collecting blood. After blood collection is complete, the tip-side of the needle tube 12 (blood collection needle 10) is pulled out of the body, and the cover part 60 is rotated using the hinge part 62. The groove bottom wall part 66 of the cover part 60 is then pressed against a desk or the like and rotated further, covering and protecting the tip-side needle tip 16 from the side with the cover part 60. This allows the blood collection needle 10 to be safely disposed of without the risk of accidental puncture. In this embodiment, multiple protrusions are formed on the outer surface of the groove bottom wall 66, making it less likely to slip when the groove bottom wall 66 is pressed against a desk or the like and rotated. The blood collection needles of the first to fifth modifications can also be attached to the blood collection tube holder 104 in the same manner and used. Furthermore, any of the blood collection needles can be attached to and used with various blood collection tube holders other than the illustrated blood collection tube holder 104.

In this embodiment and each of the modified examples, the protector that covers the tip of the needle is provided on the blood collection needle side, not on the blood collection tube holder side. This allows the blood collection tube holder to be used multiple times, thereby reducing the amount of medical waste.

In the blood collection needle 10 of this embodiment and the blood collection needles of the first to fifth modifications, the cover portion 60 is in the first position before use, and the cover portion 60 is approximately parallel to the axial direction of the needle tube 12. This allows for a compact overall configuration before use. Furthermore, the hinge portion 62 connecting the cover portion 60 to the collar portion 38 protrudes diagonally from the most distal end of the collar portion 38 toward the distal end. Therefore, before use, the end of the cover portion 60 on the side of the open end portion 72 is located approximately in the axial center of the blood collection needle 10, including both needle tip protection caps 84, 86. As shown in FIG. 21 , when two blood collection needles 10 are positioned such that the cover portions 60 face each other and the distal and proximal ends are reversed before use, the two blood collection needles 10 can be brought close enough together that one cover portion 60 abuts the needle tip protection cap 84 on the distal end of the other, allowing for efficient storage space.

When arranged as shown in Figure 21, the cover portion 60 of the protector 40 does not protrude from the needle tip protection caps 84, 86 of adjacent blood collection needles 10. Furthermore, when the blood collection needles are aligned with the ends of the protectors abutting, the cap on the base end protrudes outward more than the cap on the tip end, allowing the user to smoothly remove the blood collection needle 10 from the packaging by grasping the most protruding part. Furthermore, even when the needles are not packaged in this aligned state, the caps protruding outward from the protector will naturally guide the user to grasp them.

In this embodiment and each of the modified examples, the collar portion 38 is cylindrical, but it is not limited to a cylindrical shape; it can also be a cylindrical shape with corners. It can also be a cylindrical shape with different shapes for the outer and inner surfaces. Furthermore, while the collar portion is shaped like a continuous cylinder around the entire circumference, it can also be roughly C-shaped, with a portion of the circumference cut out. For example, the collar portion can be roughly C-shaped with a portion of the circumference cut out, and a locking claw that can lock with the rib can be provided to secure the needle hub and collar portion together. In this case, the positions of the needle hub and collar can be stabilized when adhesive is applied or melted between the needle hub and collar portion.

Although the embodiments of the present invention have been described above, the present invention should not be interpreted as being limited by the specific descriptions in these embodiments, and can be implemented in various forms with various changes, modifications, improvements, etc. based on the knowledge of those skilled in the art.

REFERENCE SIGNS LIST 10 Blood collection needle 12 Needle tube 14, 14A, 14B Needle hub 16, 20 Needle tip 22, 24 Blade surface 28 Male thread 30 Sleeve fixing portion 32, 32A Cylindrical portion 34, 34B Rib 35 Flange 36 Sleeve 38, 38B, 38C, 38D, 38E Collar portion 40, 40B, 40C, 40D, 40E Protector 42, 42a, 42b Inner cavity 44, 44a, 44b Circumferential wall 46, 46B Small diameter cylindrical portion 47 Partition wall 48 Step portion 50, 50A Large diameter cylindrical portion 52, 53 Inner protrusion portion 52a Convex portion 54 Convex portion 55 Cavity 56 Inner fitting cylinder 58 Rib 60 Cover portion 60a Needle tube accommodating portion 62 Hinge portion 66 Groove bottom wall portion 68 Side wall portion 69 Needle guide 70 Side opening 72 End opening portion 74 End wall portion 76 Needle locking portion 76A Upright wall 76B Folded portion 77 Needle position regulating portion 78 Connecting arm 80 Urging arm 84, 86 Needle tip protection cap 88, 96 Seal adhering portion 90 Insertion fixing portion 92 Protrusion 93 Rib 94, 98 Cap fitting portion 97 Rib 100 Confirmation seals 102a, 102b Slit 104 Blood collection tube holder 106 Main body portion 108 Holding portion 110 Through hole 112 Bottom wall portion 114 Peripheral wall portion 116 Outer cylindrical portion 118 Inner cylindrical portion 151 Inner protruding portion 152 Side surface 153 End face 155 Inner protrusion 155A First inner protrusion 155B Second inner protrusion 156A, 156B Side face 157A, 157B End face 161 Locking protrusions 163, 163A First fitting convex portion 162 Detent portion 164 Fitted portion 165 Second fitting convex portion 166 Pressed portion 171 Chamfered portion 172 Hollow portion 173 Gap 174 Notch

Claims (10)

a distal needle tube having a sharp needle tip;
a needle hub fixed to the distal end side needle tube;
a proximal needle tube provided on the proximal side of the needle hub;
a protector that covers the needle tip after use,
the protector accommodates the distal end needle tube therein through a side opening and includes a cover portion that covers the needle tip, a collar portion that is fitted onto and fixed to the needle hub, and a hinge portion that rotatably connects the cover portion and the collar portion;
the cover portion, the collar portion, and the hinge portion are integrally molded resin bodies,
the needle hub having a plurality of axially extending ribs and a radially outwardly extending flange;
The collar portion has a guide portion that is inserted between adjacent ribs to define its position around the axis. The blood collection needle according to claim 1, wherein the collar portion has a locking and fixing portion that locks with the needle hub, and is assembled to the needle hub via the locking and fixing portion. The blood collection needle according to claim 1, wherein the collar portion is fixed to the needle hub by fusing the base end surface of the guide portion and the tip surface of the flange together. the collar portion is a cylindrical body extending distally from the needle hub,
The blood collection needle according to any one of claims 1 to 3, wherein the connection between the hinge portion and the collar portion is located closer to the tip than the needle hub. the collar portion is a cylindrical body having a distal end side with a larger outer diameter than a proximal end side,
The blood collection needle according to any one of claims 1 to 3, wherein the hinge portion is connected to the tip side of the collar portion. a distal needle tube having a sharp needle tip;
a needle hub fixed to the distal end side needle tube;
a proximal needle tube provided on the proximal side of the needle hub;
a protector that covers the needle tip after use,
the protector accommodates the distal end needle tube therein through a side opening and includes a cover portion that covers the needle tip, a collar portion that is fitted onto and fixed to the needle hub, and a rotating portion that rotatably connects the cover portion and the collar portion;
the collar portion is a cylindrical body extending distally from the needle hub,
A blood collection needle, wherein the connection portion between the rotating portion and the collar portion is located further distal than the needle hub. a distal needle tube having a sharp needle tip;
a needle hub fixed to the distal end side needle tube;
a proximal needle tube provided on the proximal side of the needle hub;
a protector that covers the needle tip after use, the protector having a cover part that houses the distal end needle tube through a side opening and covers the needle tip, a collar part that is fitted onto and fixed to the needle hub, and a rotating part that rotatably connects the cover part and the collar part,
the collar portion is a cylindrical body having a distal end side with a larger outer diameter than a proximal end side,
The blood collection needle, wherein the rotating portion is connected to the tip side of the collar portion. a distal needle tube having a sharp needle tip;
a needle hub fixed to the distal end side needle tube;
a proximal needle tube provided on the proximal side of the needle hub;
a protector that covers the needle tip after use,
the needle hub has a cylindrical portion extending toward the distal end and a plurality of ribs extending radially outward from the cylindrical portion;
the protector accommodates the distal end needle tube therein through a side opening and includes a cover portion that covers the needle tip, a collar portion that is fitted onto and fixed to the needle hub, and a rotating portion that rotatably connects the cover portion and the collar portion;
The collar portion has an inner protrusion portion that is inserted between adjacent ribs to define its position around the axis. the collar portion has a locking and fixing portion that locks with the needle hub, and is assembled to the needle hub via the locking and fixing portion;
The blood collection needle according to claim 8 , wherein the locking fixing portion is locked to the needle hub by bringing the collar portion and the needle hub closer together in the axial direction with the inner protrusion inserted between the ribs. The blood collection needle according to claim 9, wherein the locking portion is formed on the inner protrusion and engages with the outer surface of the needle hub, thereby assembling the collar portion and the needle hub.