WO2024101414A1 - Blood collection needle - Google Patents

Abstract

Provided is a novel blood collection needle that is capable of preventing unintended detachment of a protector from a needle hub and that can stably manifest the original function of the protector, which is to protect a needle tip after use.　Provided is a blood collection needle 10 in which a protector 18 for covering a needle tip 16 after use is mounted on a needle hub 14 fixed to a needle tube 12, wherein: the needle hub 14 is fastened to the needle tube 12; a collar member 38 is fixed to the outer peripheral surface of the needle hub 14; and a protector body 40, which is made of a synthetic resin and in which an attachment part 64 is integrally molded to a cover part 60 for covering the needle tip 16 of the needle tube 12 via a bendable hinge part 62, is attached in an externally inserted manner to the collar member 38 at the attachment part 64.

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 instrument for transferring blood from a patient to a blood collection tube or the like 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-shaped protrusion, on the base end side, and 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 for use.

Incidentally, such blood collection needles are equipped with a protector that covers the needle tip after use to prevent accidental needle sticks. For example, Patent Document 1 (Patent Publication No. 4493088) discloses such a protector in which pin-shaped protrusions (92, 92) are provided on a protector (80) and the protrusions (92, 92) are fitted into holes (62, 62) formed in a collar (50) that is fitted onto the needle hub (20) of the blood collection needle (40), thereby enabling the protector (80) to be attached.

In the protector described in Patent Document 1, in consideration of the ease of assembly of the protector (80), the formation portion of the holes (62, 62) in the collar (50) has a C-shaped guide structure so that the pin-shaped protrusions (92, 92) can be easily fitted into the holes (62, 62), and the periphery of the holes (62, 62) is partially open.

Japanese Patent No. 4493088

However, although the protector described in Patent Document 1 has a shape that is easy to manufacture, the structure in which the minute projections (92, 92) are fitted into the holes (62, 62) via a C-shaped guide structure inevitably has a problem that the protector (80) is easily detached from the collar (50). In order to address this problem, instead of a connection structure between the protector and the collar by fitting using a pin, it is also possible to mold the protector and the collar integrally with a hinge portion and assemble them to the needle hub. However, in the case of a blood collection needle, since the base end side of the needle hub has a connection portion with the blood collection tube holder, the collar has to be located at the tip side of the needle hub, and therefore adhesives and the like for fixing the needle tube to the needle hub are likely to adhere to the hinge portion between the protector and the collar. And if adhesives and the like adhere to the hinge portion, there is a risk that the function of the hinge portion, i.e., the function of the protector itself to move the protector to the needle tip protection position to protect the needle tip, will not be stably exerted.

The problem to be solved by this invention is to provide a new blood collection needle that can prevent the protector from unintentionally coming off the needle hub and can stably perform the protector's original function of protecting the needle tip after use.

Below, preferred embodiments for understanding the present invention are described, but each embodiment described below is described as an example, and not only can they be used in combination with each other as appropriate, but the multiple components described in each embodiment can also be recognized and used independently as far as possible, and can also be used in combination with any of the components described in another embodiment as appropriate. As a result, the present invention is not limited to the embodiments described below, and various alternative embodiments can be realized.

The first aspect is a blood collection needle in which a protector that covers the needle tip after use is attached to a needle hub fixed to a needle tube, the needle hub is glued to the needle tube, a collar member is fixed to the outer circumferential surface of the needle hub, and a synthetic resin protector body with an attachment part integrally formed via a bendable hinge part with a cover part that covers the needle tip of the needle tube is attached in an externally inserted state to the collar member at the attachment part.

In this blood collection needle, the protector body that is attached to the needle hub and covers the needle tip has an attachment part that is fitted onto a collar member fixed to the needle hub, a cover part that covers the needle tip, and a hinge part that integrally connects the attachment part and the cover part. This prevents the cover part and the attachment part from separating, and prevents the protector body from unintentionally detaching from the needle hub. In addition, since the attachment part is not a member that is directly fixed to the needle hub, but is attached to the needle hub via the collar member, it is possible to reduce the risk of, for example, the adhesive that bonds the needle tube and needle hub adhering to the hinge part, and it is also possible to suppress adverse effects on the hinge part during manufacturing.

The second aspect is the blood collection needle according to the first aspect, in which the mounting portion of the protector body is fitted tightly onto the collar member and is attached so as to be rotatable in the circumferential direction.

In the blood collection needle of this embodiment, the attachment part is tightly fitted to the collar member, so that the attachment part can rotate in the circumferential direction relative to the collar member. This can prevent the hinge part from being damaged, for example, when the blood collection needle is screwed into the blood collection tube holder. In other words, if the attachment part is fixed to the collar member so that it cannot rotate, the user can grasp the cover part or hinge part to screw the blood collection needle into the blood collection tube holder, but this causes the screwing operation force to be applied to the hinge part, which may be damaged due to its weak strength. If the attachment part is rotatable in the circumferential direction relative to the collar member, it is possible to prevent the hinge part from being unintentionally damaged and becoming unusable, as the user cannot grasp the cover part or hinge part to screw the blood collection needle into the blood collection tube holder.

The third aspect is a blood collection needle according to the second aspect, in which, when a needle tip protection cap covering the needle tube is attached, the total axial dimension of the exposed portion of the collar member exposed on the outer circumferential surface on both axial sides of the attachment portion is larger than the axial dimension of the exposed portion of the outer circumferential surface of the attachment portion, and the axial dimension of the exposed portion of the outer circumferential surface of the attachment portion is 2 mm or more and less than 5 mm.

The blood collection needle of this embodiment prevents the protector body from unintentionally rotating when the user comes into contact with the attachment portion during operation. Therefore, for example, attachment work by screwing the blood collection tube holder onto the blood collection needle and the subsequent puncture work with the blood collection needle can be performed easily, quickly and stably. Furthermore, by setting the axial dimension of the attachment portion within the above range, not only is it possible to prevent unintentional rotation of the protector body due to contact with the attachment portion by fingers, but it is also possible to stably insert the attachment portion onto the collar member and avoid an increase in the size of the entire blood collection needle.

The fourth aspect is a blood collection needle according to any one of the first to third aspects, in which the needle hub is adhered to the needle tube by a thermosetting adhesive.

With the blood collection needle of this embodiment, the restrictions on the material of the needle hub are alleviated compared to, for example, when a photocurable adhesive is used as the adhesive for bonding the needle hub to the needle tube. In particular, when a member in which the protector body and collar member are integrally molded is fixed to the needle hub, and then the needle tube and needle hub are bonded with a thermosetting adhesive, there is a risk that the hinge portion will be deformed by the heat for hardening. However, in the present invention, since the protector body and collar member are separate bodies, it is possible, for example, to fix the collar member to the needle hub, and then bond the needle tube and needle hub with a thermosetting adhesive as in this embodiment. This also makes it possible to suppress adverse effects on the hinge portion during manufacturing by forming the protector body and collar member as separate bodies, as in the present invention.

In the fifth aspect, in the blood collection needle according to any one of the first to fourth aspects, the collar member is provided with cylindrical cap fitting portions on both axial sides of the support portion to which the mounting portion of the protector body is attached in an externally inserted state, to which a needle tip protection cap is removably attached.

With this blood collection needle, the needle tip protection cap is attached to the collar member rather than the protector body, so even if the size or shape of the needle tip protection cap is different, this can be easily accommodated by changing the design of the small collar member without having to change the shape of the larger protector body.

The sixth aspect is a blood collection needle according to any one of the first to fifth aspects, in which the collar member is fixed to the needle hub by adhesive or ultrasonic welding.

In this blood collection needle, the collar member and the needle hub are fixed by adhesion, so that sufficient fixing strength between the collar member and the needle hub can be obtained, and the collar member can be prevented from unintentionally falling off the needle hub when attaching or detaching the needle tip protection cap or when attaching the blood collection tube holder.

The seventh aspect is a blood collection needle according to any one of the first to sixth aspects, in which a needle tip protection cap is removably attached to each axial side of the collar member, and a confirmation seal is affixed to the outer circumferential surface of each of the needle tip protection caps on both axial sides of the attachment portion, and the removal resistance of the needle tip protection cap that protects the needle tip on the puncture side of the needle tube is set to be greater than the removal resistance of the needle tip protection cap that protects the needle tip on the opposite blood collection tube side.

With this blood collection needle, even if a user holds each of the needle tip protection caps with one hand and applies an operating force pulling them outward in the axial direction of the needle tube, the needle tip protection cap on one side (the side that connects to the blood collection tube holder) will naturally be removed before the needle tip protection cap on the other side (the side that punctures the human body). The resistance to removal of each of the needle tip protection caps can be set, for example, by adjusting the fixing strength of the fitting force with the collar part to which the needle tip protection cap is attached, and/or by adjusting the ease of breaking at the removal site of each needle tip protection cap on the confirmation seal, for example, by adjusting the size of the perforation-like cut set there.

The eighth aspect is a blood collection needle in which a protector that covers the needle tip after use is attached to a needle hub fixed to a needle tube, a collar member is fixed to the outer circumferential surface of the needle hub, and an attachment part integrally formed in the protector body that covers the needle tip of the needle tube is fitted onto the collar member and attached so as to be rotatable in the circumferential direction, while the total axial dimension of the exposed parts of the collar member exposed on the outer circumferential surface on both axial sides of the attachment part when a needle tip protection cap that covers the needle tube is attached is larger than the axial dimension of the exposed parts of the outer circumferential surface of the attachment part, and the axial dimension of the exposed parts of the outer circumferential surface of the attachment part is 2 mm or more and less than 5 mm.

　While continuing research aimed at preventing unintended rotation of the protector body, the inventor discovered that the protector body may rotate unintendedly if the user touches the mounting part inserted on the collar member during work. The inventor then focused on the relationship between the axial dimensions of the exposed part of the collar member exposed on the outer circumferential surface of the protector and the mounting part, and discovered that it is effective to set a specific relationship, leading to the completion of the present invention. According to this embodiment, the total axial dimension of the exposed part of the collar member is larger than the axial dimension of the mounting part, reducing the risk of the user touching the mounting part and preventing the protector body from rotating unintendedly due to the user touching the mounting part during work. Therefore, for example, it becomes possible to easily, quickly and stably perform the attachment work by screwing the blood collection tube holder to the blood collection needle and the subsequent puncture work with the blood collection needle. Furthermore, by setting the axial dimension of the attachment part within the above range, not only is it possible to prevent unintended rotation of the protector body due to contact with the attachment part by fingers, but it is also possible to stably insert the attachment part onto the collar member and to prevent the blood collection needle from becoming too large overall.

The blood collection needle of the present invention can prevent the protector from unintentional detachment from the needle hub, and can stably perform the protector's original function of protecting the needle tip after use.

FIG. 1 is a perspective view showing a blood collection needle according to a first embodiment of the present invention; FIG. 2 is a plan view of the blood collection needle shown in FIG. 3 is a cross-sectional view taken along the line III-III in FIG. FIG. 4 is an enlarged cross-sectional view showing a main part (part A) in FIG. 3 . FIG. 2 is an exploded perspective view of the blood collection needle shown in FIG. 1 from the top side. FIG. 2 is an exploded perspective view of the blood collection needle shown in FIG. 1 from the bottom side. FIG. 2 is a perspective view showing the blood collection needle shown in FIG. 1 with both needle tip protection caps removed; FIG. 8 is a longitudinal sectional view of the blood collection needle shown in FIG. 7, which corresponds to FIG. 3; FIG. 2 is a perspective view showing the blood collection needle shown in FIG. 1 with one needle tip protection cap removed and a blood collection tube holder attached; FIG. 10 is a longitudinal sectional view of the blood collection needle shown in FIG. 9, which corresponds to FIG. 3; FIG. 11 is a front view showing a blood collection needle according to a second embodiment of the present invention; FIG. 12 is a longitudinal sectional view of the blood collection needle shown in FIG. 11, which corresponds to FIG. 3; FIG. 13 is an enlarged cross-sectional view showing a main part (part B) in FIG. 12 . FIG. 12 is a perspective view of a collar member constituting the blood collection needle shown in FIG. 11 . 15 is a plan view of the collar member shown in FIG. FIG. 15 is a front view of the collar member shown in FIG.

Below, in order to clarify the present invention more specifically, an embodiment of the present invention will be described in detail with reference to the drawings.

1 to 4 show a blood collection needle 10 according to a first embodiment of the present invention in its shipping state. This blood collection needle 10 is fitted with a protector 18 that covers the needle tip 16 after use and is attached to a needle hub 14 fixed to a needle tube 12. After the blood collection needle 10 has been punctured, the protector 18 is rotated relative to the needle hub 14 to cover and protect the used blood collection needle 10 from the side. In the following description, the axial direction refers to the vertical direction in FIG. 4, which is the axial direction of the needle tube 12. The tip side refers to the upper side in FIG. 4, which is the side of the needle tube 12 that is punctured into the skin, while the base side refers to the lower side in FIG. 4, which is the side of the needle tube 12 to which a blood collection tube holder 104, described later, is attached.

More specifically, the needle tube 12 is a hollow double-ended needle, i.e., the distal and proximal ends of the needle tube 12 are provided with sharp needle tips 16, 20, respectively. Of these needle tips 16, 20, the distal tip 16 is the side that is punctured into the human body, and is covered and protected by a protector 18 after the blood collection needle 10 is used. Furthermore, the needle tips 16, 20 on both sides are formed with blade surfaces 22, 24, respectively, to facilitate puncturing, and both blade surfaces 22, 24 are inclined surfaces that are inclined relative to the axial direction.

The needle tube 12 is fixed to the needle hub 14 at its longitudinal intermediate portion or at its base end side. The needle hub 14 is generally cylindrical and may be made of, for example, a hard synthetic resin. The needle tube 12 is inserted into a central hole and bonded with an adhesive, thereby fixed to the needle hub 14. The adhesive used to bond the needle hub 14 and the needle tube 12 is not limited, but in this embodiment, a thermosetting adhesive is used, and the needle hub 14 is bonded to the needle tube 12 with the thermosetting adhesive. In particular, in this embodiment, a reservoir 26 for the thermosetting adhesive is provided at the tip of the needle hub 14, and the needle tube 12 and the needle hub 14 are bonded with a sufficient amount of thermosetting adhesive.

As also shown in Figures 5 and 6, a male thread 28 is formed on the outer peripheral surface of the needle hub 14 in the longitudinal middle portion, and a large-diameter fixing portion 30 is formed on the outer peripheral surface of the base end, protruding outward. Meanwhile, the tip portion of the needle hub 14 is a cylindrical portion 32, and the outer peripheral surface of the cylindrical portion 32 is provided with a plurality of protrusions 34 (four in this embodiment) that protrude radially outward. Furthermore, between each protrusion 34 and the male thread 28, a roughly annular seat portion 35 that protrudes outward is provided, and the seat portion 35 protrudes outward further than each protrusion 34.

A sleeve 36 is attached to 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 side opening of the sleeve 36 is engaged with the fixing part 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 on the base end side of the needle tube 12 from being exposed when not in use.

The protector 18, which is attached to the needle hub 14 and covers the distal end of the needle tip 16 after use, is composed of a collar member 38 and a protector body 40, which are separate from each other.

The collar member 38 is a generally cylindrical member and may be formed of, for example, a hard synthetic resin. That is, the collar member 38 has a peripheral wall 44 having an inner hole 42. In this embodiment, the collar member 38 has a generally stepped cylindrical shape, and the collar member 38 has a small diameter cylindrical portion 46, a generally annular step portion 48 protruding from one opening of the small diameter cylindrical portion 46 to the outer periphery, and a large diameter cylindrical portion 50 protruding from the step portion 48 to the opposite side of the small diameter cylindrical portion 46. Therefore, the inner hole 42 of the collar member 38 is formed by the inner hole 42a of the small diameter cylindrical portion 46 and the inner hole 42b of the large diameter cylindrical portion 50, and the peripheral wall 44 of the collar member 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. In addition, multiple axially extending ribs 51 (see FIG. 7 described later) are provided on the inner peripheral surface of the peripheral wall 44b of the large diameter cylindrical portion 50 at a distance from each other in the circumferential direction, so that when the large diameter cylindrical portion 50 and the inner insertion fixing portion 90 described later are fitted together, a small radial gap is provided between the inner peripheral surface of the large diameter cylindrical portion 50 and the outer peripheral surface of the inner insertion fixing portion 90.

In particular, the large diameter cylindrical portion 50 protrudes from the radially intermediate portion of the step portion 48, and the outer peripheral portion of the step portion 48 protrudes further outward than the large diameter cylindrical portion 50. The outer peripheral portion of the step portion 48 forms an abutment portion 52 against which one axial end face of the mounting portion 64 abuts when the protector body 40 described below is attached. The radial width dimension of the abutment portion 52 is approximately equal to the radial width dimension of the mounting portion 64, and when the mounting portion 64 is attached to the collar member 38 and abuts against the abutment portion 52, the outer peripheral surface of the abutment portion 52 may be located at the same position in the radial direction as the outer peripheral surface of the mounting portion 64 or may be located slightly inward or outward.

In addition, a protrusion 54 that protrudes in the same direction as the small diameter cylindrical portion 46 is provided on the end face of the step portion 48 facing the small diameter cylindrical portion 46, in other words, on the outer periphery of the small diameter cylindrical portion 46. This protrusion 54 has a certain protruding height and is provided partially on the circumference. In this embodiment, as shown in FIG. 6, each protrusion 54 is provided at multiple points (four points) on the circumference, spaced apart from each other in the circumferential direction.

Furthermore, a rib 56 extending in the axial direction of the small diameter cylindrical portion 46 is provided on the inner peripheral surface of the small diameter cylindrical portion 46. This rib 56 is formed over substantially the entire axial length of the small diameter cylindrical portion 46, and in this embodiment, multiple ribs 56 are provided spaced apart from each other in the circumferential direction.

Furthermore, a protruding rib 58 that protrudes outward is provided on the outer peripheral surface of the opening at the end of the large diameter cylindrical portion 50 opposite the side connected to the step portion 48. In this embodiment, the protruding rib 58 is provided in an annular shape around the entire circumference in the circumferential direction. The protruding rib 58 is formed with a protruding height that allows the mounting portion 64 of the protector body 40 to get over, as described below.

The collar member 38 having such a shape is fixed to the outer peripheral surface of the needle hub 14. Specifically, the needle hub 14 to which the needle tube 12 is fixed is inserted from the opening of the collar member 38 on the side of the small diameter tube portion 46. As a result, each protrusion 34 of the needle hub 14 is inserted into the small diameter tube portion 46, and the open end face of the small diameter tube portion 46 abuts against the base portion 35 that protrudes further outward than each protrusion 34. In this embodiment, each protrusion 34 is inserted into the inner peripheral surface of the peripheral wall 44a of the small diameter tube portion 46 in a substantially press-fit state, and each protrusion 34 is inserted between the circumferential ribs 56 provided on the inner peripheral surface of the peripheral wall 44a. This suppresses radial and circumferential displacement of the collar member 38 relative to the needle hub 14.

In particular, in this embodiment, the collar member 38 is fixed to the needle hub 14. The method of fixing the collar member 38 to the needle hub 14 is not limited, but it is preferable to use adhesive or ultrasonic welding. In other words, the outer peripheral surface of each protrusion 34 and the inner peripheral surface of the peripheral wall 44a, and/or the overlapping surface between the open end of the small diameter cylindrical portion 46 and the base portion 35 can be used as the fixing surface between the collar member 38 and the needle hub 14.

The protector body 40 includes a cover portion 60 that covers the needle tip 16 at the distal end of the needle tube 12, a hinge portion 62 that can be bent relative to the cover portion 60, and an attachment portion 64 that is provided via the hinge portion 62 to the cover portion 60. The protector body 40 is made of synthetic resin, and is formed as an integrally molded product that includes the cover portion 60, the hinge portion 62, and the attachment portion 64.

The cover portion 60 is formed as a longitudinal groove with a groove length dimension larger than the groove width dimension overall, that is, it has a longitudinal groove bottom wall portion 66 and a pair of side walls 68, 68 that protrude from both circumferential ends of the groove bottom wall portion 66 to one side in the thickness direction of the groove bottom wall portion 66. The groove bottom wall portion 66 and both side walls 68, 68 form a side opening 70 for covering the needle tube 12 from the side. The groove (side opening 70) of the cover portion 60 is opened at a base end side opening portion 72 on one side in the length direction (upper side in FIG. 3), while being closed at a tip end side wall portion 74 on the other side in the length direction (lower side in FIG. 3), forming a dead end shape.

Furthermore, a locking portion 76 is formed in the recessed groove of the cover portion 60 to lock the needle tube 12 and maintain the stored state when the needle tube 12 is stored in the cover portion 60. In this embodiment, the locking portion 76 protrudes from the groove bottom wall portion 66 toward the opening side of the side opening 70, and is folded back at its protruding tip toward the groove bottom wall portion 66. The needle tube 12 is locked in this folded back portion, so that the cover portion 60 maintains the needle tube 12 in a stored state.

The hinge section 62 in this embodiment is made up of multiple arms, and is made up of a connecting arm 78 that can bend as the cover section 60 rotates, and a biasing arm 80 that applies a biasing force to the cover section 60 to rotate it. In particular, in this embodiment, connecting arms 78, 78 are formed on both sides of the biasing arm 80 in the width direction.

In other words, each connecting arm 78 has a thin-walled portion in the middle of the length of the plate-like member, and can be easily bent at this thin-walled portion. In addition, the biasing arm 80 is given elasticity by bending or curving the plate-like member, and in the initial state shown in Figures 1 to 4, the cover part 60 is stabilized in a state in which the groove bottom wall part 66 and the needle tube 12 are approximately parallel, as shown.

In addition, the mounting portion 64 in this embodiment is cylindrical and extends continuously around the entire circumference. One axial end (upper in FIG. 3) of the mounting portion 64 is connected to the end of the groove bottom wall portion 66 of the cover portion 60 on the base end side opening portion 72 side by the hinge portion 62.

Here, as shown in Figures 7 and 8, the mounting portion 64 of the protector body 40 is attached in an externally inserted state to the collar member 38. Specifically, the large diameter cylindrical portion 50 of the collar member 38 is inserted into the mounting portion 64, and the mounting portion 64, which is approached from the opening side of the large diameter cylindrical portion 50 (the side opposite the step portion 48), climbs over the protruding rib 58 provided at the end of the large diameter cylindrical portion 50, so that the mounting portion 64 is externally inserted onto the large diameter cylindrical portion 50 of the collar member 38.

In other words, the portion of the collar member 38 from the base end (the portion connected to the step portion 48) of the large diameter tube portion 50 to the protruding rib 58 serves as the support portion 82 to which the mounting portion 64 of the protector body 40 is attached in an externally inserted state. Note that Figures 7 and 8 show the state in which the needle tip protection caps 84, 86 described below have been removed from both axial sides of the needle tube 12 from the initial state before use shown in Figures 1 to 4, and therefore show the state in which the confirmation sticker 100 described below is partially affixed to the outer circumferential surface of the mounting portion 64.

The axial dimension of the mounting portion 64 is approximately equal to or slightly smaller than the axial dimension of the support portion 82, which is the portion of the large diameter cylindrical portion 50 onto which the mounting portion 64 is inserted, and the mounting portion 64 is located axially inward of the protruding rib 58 when the end face of the mounting portion 64 abuts against the abutment portion 52, which is the outer periphery of the step portion 48. This prevents the mounting portion 64 from floating outward due to the protruding rib 58, and the occurrence of a large gap between the outer periphery of the large diameter cylindrical portion 50 and the inner periphery of the mounting portion 64.

Also, as shown in Figs. 4 and 6, the inner diameter dimension of the mounting portion 64 is slightly larger at the lower portion than at the upper end portion in Fig. 4. As a result, when the mounting portion 64 climbs over the protruding rib 58, the opening on the lower side of the mounting portion 64 in Fig. 4 widens, causing the inner diameter dimension to increase, and/or the protruding tip of the large diameter cylindrical portion 50 is pressed inwardly, causing the outer diameter dimension to decrease, making it easier for the mounting portion 64 to climb over the protruding rib 58.

In particular, in this embodiment, the radial width dimension of the mounting portion 64 is larger than the radial width dimension of the large diameter cylindrical portion 50, so that deformation toward the inner periphery of the large diameter cylindrical portion 50 is more likely to occur than deformation of the mounting portion 64 toward the inner periphery. This suppresses excessive deformation of the mounting portion 64, and the effect on the hinge portion 62 connected to the mounting portion 64 can be reduced. Furthermore, after the mounting portion 64 climbs over the protruding rib 58, the portion of the mounting portion 64 with the reduced inner diameter dimension (the upper end portion in FIG. 4) engages with the protruding rib 58, effectively preventing the large diameter cylindrical portion 50 from slipping out of the mounting portion 64, i.e., the protector body 40 from falling off the collar member 38.

Therefore, in this embodiment, the mounting portion 64 of the protector body 40 is fitted tightly around the large-diameter tube portion 50 of the collar member 38, and is attached so as to be rotatable in the circumferential direction. In particular, in this embodiment, the portion of the mounting portion 64 with a reduced inner diameter (the upper end portion in FIG. 4) and the outer circumferential surface of the large-diameter tube portion 50 are in contact with a certain degree of frictional force, and the protector body 40 is attached in a circumferentially positioned state in which it does not rotate freely relative to the collar member 38. In other words, by applying a circumferential external force of a predetermined amount or more to the protector body 40, the protector body 40 is made circumferentially rotatable relative to the collar member 38. Note that, in the initial state when the blood collection needle 10 is not used, the circumferential position of the cover portion 60 of the protector body 40 is not limited, but in this embodiment, as shown in FIGS. 1 to 4, in the initial state, the cover portion 60 is provided on the radial opposite side (left side in FIG. 3) to the blade surface 22 provided on the needle tip 16 on the tip side. The mounting portion 64 of the protector body 40 may be attached to the collar member 38 so that it cannot rotate in the circumferential direction. In this case, it is preferable that the mounting portion 64 is fixed to the collar member 38 at a circumferential position where the side opening 70 of the cover portion 60 of the protector body 40 is located on the radially opposite side of the blade surface 22. This reduces or avoids interference caused by the cover portion 60 when puncturing with the blade surface 22 facing forward.

Furthermore, as shown in Figures 1 to 4, 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 tip side needle tip protection cap 84 and the base side needle tip protection cap 86 are removably attached to the collar member 38. In other words, the needle tip protection caps 84, 86 are removably attached to both axial sides of the collar member 38.

The tip protection cap 84 on the tip side is shaped like a cylinder with a bottom that opens to the base end and extends in the axial direction. The tip portion of the needle tip protection cap 84 is shaped like a tapered cylinder whose outer diameter gradually decreases toward the tip side, and the axial middle portion is formed with a seal attachment portion 88 that extends in the axial direction with a substantially constant outer diameter and to which a confirmation seal 100 (described later) is affixed. The outer diameter of this seal attachment portion 88 is substantially equal to the outer diameter of the mounting portion 64 in the protector body 40.

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 member 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 pressing 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 to the large diameter cylindrical portion 50.

Furthermore, on the base end side end surface of the seal attachment portion 88, i.e., on the outer periphery side of the insertion fixing portion 90, a protrusion 92 is provided that protrudes toward the base end side. This protrusion 92 has a certain protruding height and is provided partially on the circumference. In this embodiment, as also shown in FIG. 6, each protrusion 92 is provided at multiple points (four points) on the circumference and spaced apart from each other in the circumferential direction. As a result, when the tip side needle tip protection cap 84 is fitted into the large diameter cylindrical portion 50 of the collar member 38, the protruding tip surface of each protrusion 92 abuts against the tip side end surface of the large diameter cylindrical portion 50.

The axial length of the inner fixing portion 90 is smaller than the axial length of the large diameter cylindrical portion 50 located on the outer periphery, and a region of a certain axial length of the large diameter cylindrical portion 50 that does not reach from the tip to the base end (the connection portion with the step portion 48) is a cylindrical cap fitting portion 94 that fits with the inner fixing portion 90. That is, the support portion 82 onto which the attachment portion 64 is inserted in the large diameter cylindrical portion 50 is the portion from the base end to the protruding rib 58, while the cap fitting portion 94 that fits with the inner fixing portion 90 is a region that extends a certain axial length from the tip. Therefore, in the large diameter cylindrical portion 50, the axial middle portion is a portion common to the support portion 82 and the cap fitting portion 94, and the cap fitting portion 94 is located on the tip side of the support portion 82.

Similarly, the base end side needle tip protection cap 86 is shaped like a cylinder with a generally bottomed opening at the tip end, and the base end portion is shaped like a tapered cylinder with an outer diameter that gradually decreases toward the base end. The tip end portion of the needle tip protection cap 86 is also formed with a seal attachment portion 96 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 96 is generally equal to the outer diameter of the mounting portion 64 in the protector body 40.

The inner diameter of the seal attachment portion 96 is approximately equal to or slightly smaller than the outer diameter of the small diameter tubular portion 46 in the collar member 38. This allows the needle tip protection cap 86 to be removably attached by inserting the seal attachment portion 96, which is the tip portion, onto the small diameter tubular portion 46 and pressing it into the small diameter tubular portion 46, and the seal attachment portion 96, which is the tip portion of the needle tip protection cap 86, also functions as an externally inserted and fixed portion that is externally inserted onto the small diameter tubular portion 46. This allows the proximal end side needle tip protection cap 86 to be fitted into the small diameter tubular portion 46 of the collar member 38, with the protruding tip surfaces of the protrusions 54 provided on the step portion 48 of the collar member 38 abutting against the tip end surface of the seal attachment portion 96. Also, as shown in FIG. 5, a plurality of axially extending ribs 97 are provided on the inner peripheral surface of the seal attachment portion (external insertion fixing portion) 96 at a distance from one another in the circumferential direction, so that when the small diameter cylindrical portion 46 and the seal attachment portion (external insertion fixing portion) 96 are fitted together, a small radial gap is provided between the outer peripheral surface of the small diameter cylindrical portion 46 and the inner peripheral surface of the seal attachment portion (external insertion fixing portion) 96.

The axial length of the seal attachment portion (external insertion fixing portion) 96 is greater than the axial length of the small diameter cylindrical portion 46 located on the inner circumference side, and the area of the small diameter cylindrical portion 46 over substantially the entire axial length is a cylindrical cap fitting portion 98 that fits with the seal attachment portion (external insertion fixing portion) 96. That is, in the collar member 38, the cap fitting portion 98 to which the needle tip protection cap 86 is attached is located on the base end side of the support portion 82 to which the mounting portion 64 of the protector body 40 is attached. In short, in the collar member 38, cylindrical cap fitting portions 94, 98 to which both needle tip protection caps 84, 86 are removably attached are provided on both axial sides of the support portion 82 to which the mounting portion 64 of the protector body 40 is attached in an externally inserted state.

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 member 38, so that the outer peripheral surface of the seal attachment portion 88 of the needle tip protection cap 84, the outer peripheral surface of the mounting portion 64, and the outer peripheral surface of the seal attachment portion 96 of the needle tip protection cap 86 are positioned on approximately the same circumferential surface. A confirmation seal 100 is affixed to the outer peripheral surface of the mounting portion 64, extending to the outer peripheral surfaces of the seal attachment portions 88, 96 of the needle tip protection caps 84, 86 on both axial sides.

This confirmation seal 100 is not limited in any way, but may be, for example, a resin tape with an adhesive applied to the inner surface. The confirmation seal 100 has a certain circumferential dimension, and in this embodiment, it is formed with a circumferential dimension of about 1/4 of the circumference. The circumferential attachment position of the confirmation seal 100 is also not limited, but in this embodiment, in the initial state, the confirmation seal 100 is attached on the radially opposite side of the cover portion 60 of the protector body 40, in other words, on the same side as the tip of the needle 16 on the distal end side where the blade surface 22 is provided.

Furthermore, in this embodiment, the confirmation seal 100 is provided with perforated slits 102a, 102b so that the confirmation seal 100 can be easily torn when the needle tip protection caps 84, 86 are removed from the collar member 38. In particular, in this embodiment, the slit 102a that is torn when the tip side needle tip protection cap 84 is removed is provided at a position that approximately corresponds to the tip of the mounting part 64, and the slit 102b that is torn when the base side needle tip protection cap 86 is removed is provided at a position that approximately corresponds to the base end of the mounting part 64. By visually checking this confirmation seal 100 from the outside, it is easy to check whether the confirmation seal 100 has been torn, i.e., whether the blood collection needle 10 has been used.

Furthermore, in this embodiment, the removal resistance of the needle tip protection cap 84, which protects the needle tip (needle tip 16 on the distal end) 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 (needle tip 20 on the proximal end) 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 insertion fixing portion 90 and the cap fitting portion 94, the fitting force between the external insertion fixing portion (seal attachment portion 96) and the cap fitting portion 98, the ease of breaking of each slit 102a, 102b in the confirmation seal 100, etc. The resistance to removal of the tip protection cap 84 on the distal end side is set to be greater than the resistance to removal of the base end side needle tip protection cap 86. 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 base end side needle tip protection cap 86 can be removed before the tip end side needle tip protection cap 84 without having to worry about which one to remove first.

Below, a specific example of a method for assembling the blood collection needle 10 of this embodiment is 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 the needle hub 14 are bonded together with a thermosetting adhesive (reservoir 26). Then, a sleeve 36 is attached to the fixed 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, a collar member 38 is inserted from the tip side onto the needle hub 14 to which the needle tube 12 is fixed, and the needle hub 14 (each protrusion 34) and the small diameter tube portion 46 of the collar member 38 are fixed together by ultrasonic welding. Then, silicone oil, which acts as a lubricant when puncturing the human body, is applied to the outer peripheral surface of the part of the needle tube 12 protruding from the needle hub 14. In this way, by applying silicone oil after bonding or welding, it is possible to avoid a decrease in adhesion or weldability due to silicone oil dripping or adhering to the bonding or welding points, compared to when silicone oil is applied before bonding or welding. When silicone oil is applied to the outer peripheral surface of the portion of the needle tube 12 that protrudes from the needle hub 14 toward the base end, the sleeve 36 may be temporarily removed, or the sleeve 36 may be attached to the fixing portion 30 of the needle hub 14 after silicone oil is applied to the outer peripheral surface of the portion of the needle tube 12 that protrudes from the needle hub 14.

Next, the attachment portion 64 of the protector body 40 is brought close to the collar member 38 from the tip side, and the attachment portion 64 climbs over the protruding rib 58 of the large diameter cylindrical portion 50, thereby attaching the protector body 40 to the collar member 38. Then, the tip and base end needle tip protection caps 84, 86 are fitted and attached to the large diameter cylindrical portion 50 and small diameter cylindrical portion 46 of the collar member 38, respectively. After that, a confirmation seal 100 is affixed across the needle tip protection cap 84, the attachment portion 64 of the protector body 40, and the 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 in a sealable container or the like, and sterilized. As a result, sterilized gas is filled inside the blood collection needle 10 on the tip side of the needle hub 14 through the circumferential gaps between the protrusions 92 provided on the needle tip protection cap 84 on the tip side and the radial gap between the large diameter tube portion 50 and the internal insertion fixing portion 90, and sterilization is performed. Also, sterilized gas is filled inside the blood collection needle 10 on the base end side of the needle hub 14 through the circumferential gaps between the protrusions 54 provided on the collar member 38 and the radial gap between the small diameter tube portion 46 and the seal attachment portion (external insertion fixing portion) 96, and sterilization is performed. Thereafter, the blood collection needle 10 is individually packaged, for example, and is ready for shipment.

Below, a specific example of how to use the blood collection needle 10 of this embodiment is 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 taken out, and the needle tip protection caps 84, 86 on both axial sides are grasped with one of the fingers, and for example, one needle tip protection cap (e.g., the tip side needle tip protection cap 84) is pulled out in a direction (axial direction) that separates the other needle tip protection cap (e.g., the base end side needle tip protection cap 86) from the other needle tip protection cap (e.g., the tip side needle tip protection cap 84). The needle tip protection cap on the fixed side may be on the tip side or the base end side, and in this embodiment, the removal resistance force of the tip side needle tip protection cap 84 is made larger than the removal resistance force of the base end side needle tip protection cap 86. Therefore, by fixing one needle tip protection cap and pulling out the other needle tip protection cap in the axial direction, the base end side needle tip protection cap 86 is removed before the tip side needle tip protection cap 84. Then, as shown in Figures 9 and 10, a blood collection tube holder 104 is connected to the base end side of the needle tube 12 from which the needle tip protection cap 86 has been removed.

The specific structure of the blood collection tube holder 104 is not limited, but the blood collection tube holder 104 shown in Figures 9 and 10 is generally cylindrical and is composed of a main body 106 and a holding part 108 that is inserted from the base end side of the main body 106.

The main body 106 comprises an annular bottom wall 112 that extends in the direction 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 peripheral edge of the bottom wall 112 toward the base end. An outer peripheral cylinder 116 and an inner peripheral cylinder 118 that protrude toward the tip end are provided on the peripheral edge of the through hole 110 in the bottom wall 112, and a female thread 120 that corresponds to the male thread 28 of the needle hub 14 is formed on the inner peripheral surface of the inner peripheral cylinder 118.

The holding portion 108 has a generally cylindrical shape overall, and includes a tubular portion 122 that extends in a generally straight line, and multiple (four in this embodiment) holding claw portions 124 that protrude from the tip of the tubular portion 122 toward the tip side and are elastically deformable in the radial direction. The holding portion 108 is inserted from the base end opening of the main body portion 106 as described above, and is fixed, for example, by a recessed and protruding engagement, thereby forming the blood collection tube holder 104.

Then, the base end side needle tip 20 of the needle tube 12 covered with the sleeve 36 is inserted into the blood collection tube holder 104 through the through hole 110, and the male thread 28 of the needle hub 14 and the female thread 120 of the inner cylindrical portion 118 are screwed 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 in this connected state, the small diameter cylindrical portion 46 of the collar member 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 out in the axial direction 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, and the needle tip 20 on the base end side of the needle tube 12 is connected to the blood collection tube by penetrating the sleeve 36, thereby collecting blood. After blood collection is completed, 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 by the hinge part 62 to cover and protect 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 erroneous puncture.

In the blood collection needle 10 of this embodiment, which is constructed as described above, the collar member 38 fixed to the outer peripheral surface of the needle hub 14 and the protector body 40, in which the cover portion 60, the hinge portion 62, and the mounting portion 64 are integrally formed, are provided as separate bodies, and the mounting portion 64 is attached to the collar member 38 in an externally inserted state. This reduces the risk that the cover portion 60 will unintentionally detach from the mounting portion 64, the collar member 38, and the needle hub 14. In addition, the needle tube 12 and the needle hub 14 are fixed to each other with an adhesive, and the collar member 38 is fixed to the needle hub 14, and then the protector body 40 is attached to the collar member 38. This prevents the adhesive that bonds the needle tube 12 and the needle hub 14 from adhering to the hinge portion 62 in the protector body 40, and thus prevents the hinge portion 62 from being adversely affected during the manufacture of the blood collection needle 10. As a result, after using the blood collection needle 10, the cover part 60 can be rotated by the hinge part 62 to stably protect the needle tip 16 at the tip side, allowing the protector 18 to more reliably perform its original function.

In addition, the mounting portion 64 of the protector body 40 is fitted tightly around the collar member 38 and is rotatable in the circumferential direction, which prevents the cover portion 60 and the mounting portion 64 from being unintentionally rotated relative to the collar member 38. Therefore, for example, when puncturing the blood collection needle 10, the cover portion 60 can be moved in the circumferential direction to a position preferred by the operator (puncture operator), and it is possible to avoid the cover portion 60 becoming an obstacle to the puncture operation, such as making it difficult to see the puncture position. By making the cover portion 60 rotatable relative to the needle hub 14, it is possible to make it difficult to perform the operation while holding the cover portion 60 when screwing the male thread 28 of the needle hub 14 and the female thread 120 of the blood collection tube holder 104 during the operation of connecting the needle hub 14 and the blood collection tube holder 104, and the risk of damage to the hinge portion 62, which is the connection portion between the cover portion 60 and the mounting portion 64, can be reduced.

Furthermore, in this embodiment, the needle tube 12 and the needle hub 14 are bonded with a thermosetting adhesive (reservoir portion 26). This allows for greater freedom in the selection of materials than when a light-curing adhesive is used as the adhesive. In particular, even when the needle tube 12 and the needle hub 14 are bonded with a thermosetting adhesive, as in this embodiment, by bonding them together, fixing the collar member 38 to the needle hub 14, and then attaching the protector body 40 to the collar member 38, it is possible to avoid damage to the hinge portion 62 of the protector body 40 due to the heat required for bonding.

Furthermore, in this embodiment, needle tip protection caps 84, 86 that cover the needle tips 16, 20 on both sides of the needle tube 12 are attached to the collar member 38. This means that even if the shape of the needle tip protection caps 84, 86 needs to be changed, it can be accommodated by changing the shape of the collar member 38. In other words, by appropriately changing the shape of the collar member 38, it is possible to use needle tip protection caps of conventional structure.

In addition, it is preferable that the collar member 38 is fixed to the needle hub 14 by adhesive or ultrasonic welding, which ensures sufficient fixing strength between the collar member 38 and the needle hub 14. As a result, the collar member 38 can be prevented from falling off the needle hub 14 when attaching or detaching the needle tip protection caps 84, 86 or when connecting the blood collection tube holder 104.

Furthermore, in this embodiment, in the initial state before use, a confirmation sticker 100 is affixed across both needle tip protection caps 84, 86, and the removal resistance of the tip protection cap 84 on the distal end side is set to be greater than the removal resistance of the base end side needle tip protection cap 86. This allows the base end side needle tip protection cap 86 to be removed naturally when removing the needle tip protection caps without having to worry about which needle tip protection cap to remove, making the needle tip protection cap removal process easier and reducing the risk of, for example, accidentally removing the tip end side needle tip protection cap 84.

Next, Figures 11 to 13 show a blood collection needle 130 as a second embodiment of the present invention in its shipped state. The basic structure of the blood collection needle 130 in this embodiment is similar to that of the blood collection needle 10 in embodiment 1, with a protector 132 attached to the needle hub 14 fixed to the needle tube 12, which covers the needle tip 16 after use. The protector 132 is composed of a collar member 134 and a protector body 136, which are separate from each other. In the following explanation, the same reference numerals as in the first embodiment are used in the figures to designate members and parts that are substantially the same as those in the first embodiment, and detailed explanations will be omitted.

As shown in Figures 14 to 16, the collar member 134 of this embodiment is also a generally cylindrical member, and an inner hole 42 is formed in the center of the collar member 134, penetrating in the axial direction. The outer diameter dimension of the collar member 134 is larger at the tip end side (upper side in Figure 16) than at the base end side (lower side in Figure 16), and the base end side portion of the collar member 134 is the small diameter cylindrical portion 46. In the first embodiment, the large diameter cylindrical portion 50 is provided with a step portion 48 on the small diameter cylindrical portion 46, but in this embodiment, a double cylinder is formed with the inner and outer radial sides connected to the small diameter cylindrical portion 46 via the step portion 48, and this double cylinder is composed of an inner cylindrical portion 138 and an outer cylindrical portion 140.

That is, the small diameter cylinder portion 46 protrudes toward the base end from the step portion 48 that spreads in an annular shape in the axis-perpendicular direction, and the inner circumference side cylinder portion 138 and the outer circumference side cylinder portion 140 protrude toward the tip end from the step portion 48. In this embodiment, the inner circumference side cylinder portion 138 protrudes from the inner circumference end of the step portion 48 that spreads in an annular shape, and the outer circumference side cylinder portion 140 protrudes from the outer circumference end of the step portion 48. The small diameter cylinder portion 46 protrudes from a position corresponding to the radial distance between the inner circumference side cylinder portion 138 and the outer circumference side cylinder portion 140 in the step portion 48. As in the first embodiment, a plurality of protrusions 54 are provided on the end surface of the step portion 48 on the side of the small diameter cylinder portion 46. In this embodiment, each protrusion 54 is provided on the outer circumference end of the step portion 48 that spreads in an annular shape.

Therefore, the inner circumferential side tube portion 138 is a cylindrical portion having a smaller diameter than the small diameter tube portion 46, and the internal space of the inner circumferential side tube portion 138 and the internal space of the small diameter tube portion 46 are connected to each other in the axial direction to form the above-mentioned inner hole 42. The inner circumferential side tube portion 138 has a generally straight cylindrical shape, and the outer diameter dimension and the inner diameter dimension are generally constant over the entire length in the axial direction. In addition, an anti-rotation rib 142 extending in the axial direction is provided on the outer circumferential surface of the inner circumferential side tube portion 138, and this anti-rotation rib 142 abuts in the circumferential direction against a rib 178 provided on the inner circumferential surface of the tip side needle tip protection cap 170 described later, thereby preventing circumferential rotation of the tip side needle tip protection cap 170 relative to the collar member 134, and therefore relative to the needle hub 14 and needle tube 12. In this embodiment, multiple (four) anti-rotation ribs 142 are provided on the outer circumferential surface of the inner circumferential cylindrical portion 138, and each anti-rotation rib 142 is spaced apart from the others and provided at approximately equal intervals in the circumferential direction. Also, in this embodiment, each anti-rotation rib 142 is formed with an axial dimension smaller than that of the inner circumferential cylindrical portion 138.

In particular, in this embodiment, the tip end surface of each anti-rotation rib 142 includes a curved surface 144 in the circumferential center and a pair of inclined surfaces 146, 146 that extend continuously from the circumferential ends of the curved surface 144. As a result, when the tip-side needle tip protection cap 170 is attached to the collar member 134, the rib 178 abuts against the curved surface 144 of each anti-rotation rib 142 from the tip side, and the rib 178 is guided to one circumferential side of each anti-rotation rib 142 by the curved surface 144 and the inclined surface 146 on one side in the circumferential direction, making it easier for the rib 178 to be positioned between the anti-rotation ribs 142 in the circumferential direction. And, by providing each of the anti-rotation ribs 142 as described above on the inner peripheral side tube portion 138, when removing the tip-side needle tip protection cap 170, the needle tip protection cap 170 does not rotate in the circumferential direction, and can be removed by pulling it out toward the tip side in the axial direction.

The outer circumferential cylinder 140 is generally cylindrical and extends in a straight line, and the inner diameter is generally constant over the entire length in the axial direction. In the first embodiment, the step 48 protrudes outward from the large diameter cylinder 50 to form an annular abutment 52 against which the mounting portion 64 abuts. In this embodiment, the abutment 148 protrudes outward from the axial middle portion of the outer circumferential cylinder 140, and abuts the mounting portion 168 when the mounting portion 168 is attached to the collar member 134. That is, in the first embodiment, the abutment 52 is located at the same axial position as the step 48, whereas in this embodiment, the abutment 148 is located somewhat distal to the step 48. This allows the distal end face of the abutment 148 to be located further distal than in the first embodiment, for example, and ensures a relatively large axial dimension c from the distal end face of the abutment 148 to the base end face of each protrusion 54.

The abutment portion 148 protrudes from the peripheral wall portion constituting the outer circumferential side tube portion 140 to a certain extent toward the outer circumferential side. In this embodiment, the radial width dimension (protruding dimension toward the outer circumferential side) of the abutment portion 148 is approximately equal to the radial width dimension of the attachment portion 168, and when the attachment portion 168 is attached to the collar member 134 and abuts against the abutment portion 148, the outer circumferential surface of the abutment portion 148 may be located at the same position radially as the outer circumferential surface of the attachment portion 168 or may be located slightly on the inner or outer circumferential side.

In addition, a plurality of ribs 149 are provided at a distance from each other in the circumferential direction on the outer peripheral surface of the portion of the outer peripheral side tube portion 140 that is closer to the base end than the abutment portion 148, and the unevenness that includes these plurality of ribs constitutes the anti-slip portion 150. When using the blood collection needle 130, the user can easily attach the blood collection tube holder 104 and remove the needle tip protection caps 170, 172 by holding the anti-slip portion 150, and can also prevent contact with the attachment portion 168. In this embodiment, the outer peripheral surface of the base end portion of each rib 149 that constitutes the anti-slip portion 150 is provided with a curved surface 152 that gradually curves inward as it approaches the base end, and when the base end side needle tip protection cap 172 (described later) is attached to the collar member 134, each curved surface 152 provides a relatively smooth continuity from the outer peripheral surface of the abutment portion 148 to the outer peripheral surface of the needle tip protection cap 172.

Furthermore, in the peripheral wall of the outer circumferential side tube portion 140, a slit 154 extending in the axial direction is provided on the tip side of the abutment portion 148, and the slit 154 penetrates the peripheral wall in the thickness direction (radial direction). In this embodiment, four slits 154 are formed at approximately equal intervals in the outer circumferential side tube portion 140. Furthermore, the circumferential spaces between each slit 154 in the outer circumferential side tube portion 140 form support wall portions 156 that are elastically deformable in the radial direction. Therefore, the outer circumferential side tube portion 140 is provided with four support wall portions 156 spaced apart from each other in the circumferential direction.

In particular, in this embodiment, as shown in FIG. 13, a chamfered curved surface 158 is provided on the inner peripheral surface at the tip of each support wall portion 156. In addition, a chamfered curved surface 160 is also provided on the inner peripheral surface of the outer peripheral side tube portion 140 at the portion located at the lower end of each slit 154. By providing these curved surfaces 158, 160, when the tip side needle tip protection cap 170 is attached to the collar member 134, the opening side end of the needle tip protection cap 170 (the inner insertion fixing portion 176 described later) can be attached without getting caught on the inner peripheral surface of the outer peripheral side tube portion 140.

Furthermore, the inner peripheral surface of each support wall portion 156 is provided with a pressure-contact rib 162 extending in the axial direction. When the distal end side needle tip protection cap 170 is attached to the collar member 134, these pressure-contact ribs 162 are adapted to be pressed against the open end (inserted fixed portion 176) of the needle tip protection cap 170, thereby improving the retention force of the collar member 134 for the needle tip protection cap 170 and preventing the needle tip protection cap 170 from unintentionally falling off the collar member 134. Four of these pressure-contact ribs 162 are provided on the inner peripheral surface of the outer peripheral side tube portion 140, and the four pressure-contact ribs 162 are formed at approximately equal intervals spaced apart in the circumferential direction.

An engaging piece 164 that engages with an attachment portion 168 (described later) is provided on one axial end of the collar member 134. In this embodiment, an engaging piece 164 that protrudes outward from the tip of each support wall portion 156 is integrally formed with the collar member 134. Each engaging piece 164 is provided over the entire circumferential length of each support wall portion 156. Each engaging piece 164 also protrudes outward from each support wall portion 156 with a certain protruding dimension.

In this embodiment, the protruding dimension of each locking piece 164 from each support wall portion 156 is different in the axial direction, and the tip end face of each locking piece 164 is configured as a curved surface 166 whose protruding dimension toward the outer periphery gradually increases toward the base end side. In addition, the base end face of each locking piece 164 is a flat surface that spreads in the axial direction with a certain width dimension (protruding dimension toward the outer periphery) and extends in a substantially arc shape in a plan view. As a result, the base end face of each locking piece 164 and the tip face of the abutment portion 148 face each other at a predetermined distance in the axial direction. The space between the opposing faces of the base end face of each locking piece 164 and the tip face of the abutment portion 148 is an annular accommodation space 167 that continues around the entire circumference, and when the attachment portion 168 is attached, the attachment portion 168 is accommodated in the accommodation space 167.

Furthermore, the protruding dimension of each locking piece 164 from each support wall portion 156 is greatest at the base end face of each locking piece 164. In this embodiment, the maximum radial width dimension of each locking piece 164 (the protruding dimension toward the outer periphery at the base end face) is approximately equal to the radial width dimension of the mounting portion 168, and when the mounting portion 168 is attached to the collar member 134, the outer periphery end face of each locking piece 164 is located at the same position radially as the outer periphery face of the mounting portion 168 or is located slightly on the inner or outer periphery side.

The mounting portion 168 of the protector body 136 is attached to the collar member 134 in an externally inserted state. In this embodiment, the mounting portion 168 is also a generally cylindrical portion that is formed integrally and continuously with the hinge portion 62. The inner diameter of the mounting portion 168 is slightly larger than the outer diameter of the support wall portion 156 (the imaginary outer diameter when it is assumed that the support wall portions 156 are continuous in the circumferential direction) and is smaller than the maximum outer diameter of the locking pieces 164 (the imaginary maximum outer diameter when it is assumed that the locking pieces 164 are continuous in the circumferential direction).

This mounting portion 168 is assembled to the collar member 134 from the tip side. That is, when assembling the mounting portion 168 to the collar member 134, the mounting portion 168 is brought closer to the collar member 134 from the tip side, so that the inner peripheral end portion on the base end side of the mounting portion 168 comes into contact with the curved surfaces 166 of the locking pieces 164 provided on the tip side of the collar member 134. From this state, by pushing the mounting portion 168 toward the base end side relative to the collar member 134, each support wall portion 156 is elastically deformed toward the inner peripheral side, and the maximum outer diameter dimension of the locking pieces 164 gradually becomes smaller as each support wall portion 156 elastically deforms toward the inner peripheral side. When the maximum outer diameter of the locking piece 164 becomes smaller than the inner diameter of the mounting portion 168, each support wall portion 156 and each locking piece 164 can be inserted through the inner hole of the mounting portion 168, and when the mounting portion 168 overcomes each locking piece 164, each support wall portion 156 elastically restores its original shape, and the mounting portion 168 is inserted onto each support wall portion 156, and each locking piece 164 is locked to the mounting portion 168. In this way, the mounting portion 168 is accommodated in the accommodation space 167 in the collar member 134, and the mounting portion 168 in the protector body 136 is inserted onto the collar member 134, forming the protector 132.

As in the first embodiment, the mounting portion 168 is preferably fitted tightly onto each of the support walls 156 of the collar member 134, and is preferably attached in a circumferentially positioned state in which the inner circumferential surface of the mounting portion 168 and the outer circumferential surface of each of the support walls 156 abut with a certain degree of friction, so that the protector body 136 does not rotate freely relative to the collar member 134. In short, it is preferable that the protector body 136 be made circumferentially rotatable relative to the collar member 134 by applying a circumferential external force of a predetermined amount or more to the protector body 136.

Then, as described above, the distal and proximal needle tip protection caps 170, 172 are removably attached to the collar member 134 to which the mounting portion 168 (protector body 136) is attached. The shapes of the distal and proximal needle tip protection caps 170, 172 in this embodiment are similar to the shapes of the distal and proximal needle tip protection caps 84, 86 in the first embodiment, respectively.

That is, the distal end side needle tip protection cap 170 is provided with a seal attachment section 174 in the axial middle section to which a confirmation seal 182 (described later) is attached, and an insertion fixing section 176 is provided in the proximal end section which is inserted into and fixed to the outer circumferential tube section 140 of the collar member 134. The inner peripheral surface of the needle tip protection cap 170 is provided with a plurality of ribs 178 which extend in the axial direction and protrude inward from the axial middle section to the proximal opening. Also, on the proximal end surface of the seal attachment section 174, on the outer peripheral side of the insertion fixing section 176, a protrusion 92 which protrudes toward the proximal end is provided.

Similarly, the needle tip protection cap 172 on the base end side is provided with a seal attachment section 180 at the tip portion to which a confirmation seal 182 (described later) is attached, and this seal attachment section 180 constitutes an externally inserted and fixed section that is externally inserted and fixed to the small diameter tube section 46 of the collar member 134.

In the first embodiment, the outer diameter of the tip and base seal attachment parts 88, 96 is approximately equal to the outer diameter of the mounting part 64, but in this embodiment, the outer diameter of the tip and base seal attachment parts 174, 180 is approximately equal to the outer diameter of the outer circumferential tube part 140 of the collar member 134 (excluding the parts that protrude to the outer circumferential side, such as the abutment part 148 and each locking piece 164).

The above-mentioned distal end needle tip protection cap 170 is assembled to the collar member 134 so as to cover the distal end of the needle tube 12. That is, the inner insertion fixing portion 176 of the needle tip protection cap 170 is inserted in a roughly press-fit state radially between the inner circumferential side tube portion 138 and the outer circumferential side tube portion 140 at the distal end portion of the collar member 134 having a double-tube structure, thereby assembling the distal end needle tip protection cap 170 to the collar member 134. The insertion of the needle tip protection cap 170 into the collar member 134 is regulated by the projections 92 protruding from the seal attachment portion 174 to the base end abutting against the distal end face of the collar member 134 (the distal end face of each support wall portion 156 or each locking piece 164), as shown in FIG. 13, for example. In this case, the base end surface of the insertion fixing portion 176 of the needle tip protection cap 170 may be located, for example, beyond the mounting portion 168 and closer to the base end surface than the tip end surface of the abutment portion 148.

On the other hand, the base end side needle tip protection cap 172 is assembled to the collar member 134 so as to cover the base end side of the needle tube 12, as in the first embodiment. That is, the seal attachment portion (external insertion and fixing portion) 180 of the needle tip protection cap 172 is externally inserted in a substantially press-fit state into the small diameter tube portion 46 at the base end side portion of the collar member 134, thereby assembling the base end side needle tip protection cap 172 to the collar member 134. The external insertion of the needle tip protection cap 172 onto the collar member 134 is regulated by the projections 54 protruding from the step portion 48 to the base end side abutting against the tip end face of the needle tip protection cap 172 (the tip end face of the seal attachment portion 180), as shown in FIG. 13, for example.

When the needle tip protection caps 170, 172 are attached to the distal end and proximal end of the collar member 134 as described above, as shown in Figs. 11-13, the locking pieces 164, the contact portions 148 to the non-slip portion 150, and the mounting portion 168 of the collar member 134 protrude radially outward from the peripheral surfaces of the seal attachment portions 174, 180 of the needle tip protection caps 170, 172. The distal end surfaces of the locking pieces 164 and the peripheral surfaces of the proximal end portions of the ribs 149 that constitute the non-slip portion 150 are provided with curved surfaces 166, 152, respectively, and the outer diameters of the locking pieces 164 and the contact portions 148 are approximately equal to the outer diameter of the mounting portion 168, so that the peripheral surface of the seal attachment portion 174 on the distal side to the peripheral surface of the seal attachment portion 180 on the proximal side are approximately smoothly continuous in the axial direction.

Therefore, in this embodiment, when the needle tip protection caps 170, 172 are attached, a part of the collar member 134 of the protector 132 and the attachment portion 168 of the protector body 136 are exposed on the outer circumferential surface. Specifically, the locking pieces 164 that protrude outward from the collar member 134 and the portion extending from the tip end face of the abutment portion 148 to the base end face of each protrusion 54 are exposed on the outer circumferential surface.

Then, as in the first embodiment, the confirmation seal 182 is affixed across the outer circumferential surface of the seal affixing portion 174 on the tip side and the outer circumferential surface of the seal affixing portion 180 on the base side. As in the first embodiment, the confirmation seal 182 of this embodiment also has slits 184a, 184b at positions that generally correspond to the tip and base ends of the mounting portion 168. Note that the confirmation seal 182 is omitted from FIG. 11, and the confirmation seal 182 is shown in FIGS. 12 and 13. The confirmation seal 182 of this embodiment has the same effect as the confirmation seal 100 of the first embodiment. As described above, by providing the curved surfaces 166, 152, the outer circumferential surface of the seal affixing portion 174 on the tip side is generally smoothly continuous with the outer circumferential surface of the seal affixing portion 180 on the base side. Therefore, even if a part of the protector 132 protrudes to the outer circumferential side as in this embodiment, the confirmation seal 182 can be affixed without bending.

Here, in this embodiment, when the needle tip protection caps 170, 172 are attached to both the distal and proximal sides of the collar member 134, the total axial dimension of the exposed portion of the collar member 134 exposed to the outer circumferential surface on both axial sides of the attachment portion 168 is larger than the axial dimension of the exposed portion of the outer circumferential surface of the attachment portion 168. Specifically, as shown in FIG. 13, when the axial dimension of each locking piece 164 protruding to the outer circumferential side on the distal side of the collar member 134 is a, the axial dimension of the outer circumferential surface of the attachment portion 168 is b, and the axial dimension from the distal end face of the abutment portion 148 to the proximal end face of each protrusion 54 on the proximal side of the collar member 134 is c, the total axial dimension (a+c) of the exposed portion of the collar member 134 is larger than the axial dimension b of the outer circumferential surface of the attachment portion 168 ((a+c)>b).

Furthermore, it is preferable that the axial dimension b of the outer peripheral surface of the attachment portion 168 is set to an axial dimension that is 2 mm or more and less than 5 mm (2 mm≦b<5 mm). That is, by making the axial dimension b of the outer peripheral surface of the attachment portion 168 2 mm or more, the strength of the attachment portion 168 is ensured when the attachment portion 168 is inserted into each support wall portion 156 of the collar member 134. Furthermore, by making the axial dimension b of the outer peripheral surface of the attachment portion 168 smaller than 5 mm, it is possible to prevent the overall axial dimension of the blood collection needle 130 from becoming excessively large.

The specific values of the above-mentioned axial dimensions a, b, and c are not limited, but for example, the axial dimension a of each locking piece 164 is set to 1 mm to 2 mm, the axial dimension b of the outer peripheral surface of the attachment portion 168 is set to 2 mm, and the axial dimension c from the tip end face of the abutting portion 148 to the base end face of each protrusion 54 is set to 4 mm. In addition, the axial dimension of the entire portion exposed to the outer peripheral surface (i.e., the axial dimension from the tip end face of each locking piece 164 to the base end face of each protrusion 54) is set to, for example, within the range of 8 mm to 9 mm. Therefore, in this embodiment, the axial dimension c from the tip end face of the abutting portion 148 to the base end face of each protrusion 54 is set to be larger than the axial dimension a of each locking piece 164 (a < c).

The method of using the blood collection needle 130 of this embodiment is the same as that of the blood collection needle 10 of the first embodiment. That is, from the blood collection needle 130 in the shipped state shown in Figures 11 to 13, first, the base end needle tip protection cap 172 is pulled out toward the base end in the axial direction. Then, the female thread 120 of the blood collection tube holder 104 shown in Figures 9 and 10 is screwed into the male thread 28 provided on the base end side of the needle hub 14, and the blood collection tube holder 104 is connected to the base end side of the needle tube 12. From this state, the tip end needle tip protection cap 170 is pulled out toward the tip end in the axial direction to expose the tip end needle tip 16, which is then punctured into the human body. When removing the above-mentioned needle tip protection caps 170, 172 or screwing and connecting the blood collection tube holder 104, the risk of contacting the attachment portion 168 can be reduced by placing the fingers on the anti-slip portion 150 provided on the base end side of the collar member 134.

In the blood collection needle 130 of this embodiment having such a structure, the protector body 136 is attached to the collar member 134 in an externally inserted state at the attachment portion 168, so that the same effect as in the first embodiment can be achieved. In particular, in the blood collection needle 130 of this embodiment, when the needle tip protection caps 170, 172 are attached, the total axial dimension (a+c) of the part exposed to the outer circumferential surface of the collar member 134 is larger than the axial dimension b of the outer circumferential surface of the attachment portion 168. This can prevent, for example, the protector body 136 from unintentionally rotating in the circumferential direction when the finger touches only the attachment portion 168 during the operation of screwing the blood collection tube holder 104 into the base end side of the needle tube 12. As a result, for example, the cover portion 60, which is provided at a circumferential position that does not interfere with the puncturing operation of the blood collection needle 130 in the initial state, from unintentionally rotating and interfering with the connection operation of the blood collection tube holder 104 or the puncturing operation of the blood collection needle 130.

Although the embodiments of the present invention have been described above, the present invention should not be interpreted in a limited manner based on 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.

For example, in the above embodiment, the attachment portion 64, 168 of the protector body 40, 136 is rotatable relative to the collar member 38, 134, but the protector body does not have to be rotatable relative to the collar member, and in the blood collection needle according to the present invention, the cover portion may be provided in a fixed position in the circumferential direction.

In the first embodiment, the collar member 38 has a generally stepped cylindrical shape with a step portion 48, but the step portion is not essential and the collar member may have, for example, a straight tubular shape. The shape of the collar member can be changed to match the shape of the needle tip protection caps attached to both sides, but the needle tip protection caps may be attached to a member other than the collar member, and the shape of the collar member may be changed regardless of the shape of the needle tip protection caps.

In the above embodiment, the mounting portion 64, 168 of the protector body 40, 136 is cylindrical and continuous around the entire circumference, but it may be, for example, approximately C-shaped with a portion of the circumference cut out. That is, the mounting portion may be elastically deformed when it is inserted onto the cover member, and the cover member side may not be elastically deformed. Specifically, in the collar member 134 in the second embodiment, the slits 154 and the curved surfaces 166 of the locking pieces 164 are not essential, and the support walls 156 do not have to be elastically deformable in the radial direction. Therefore, it is sufficient for the collar member to have an annular storage space in which the mounting portion can be stored in an inserted state, and the approximately C-shaped mounting portion may be pushed into the storage space from the side (perpendicular to the axis) to be assembled.

In the above embodiment, the collar members 38, 134 are fixed to the needle hub 14 by adhesive or ultrasonic welding, but the collar members and the needle hub may be fixed by a method other than adhesive or welding, such as recess-projection fitting or press fitting. Note that in the above embodiment, the needle tube 12 and the needle hub 14 are bonded with a thermosetting adhesive, but after the collar members and the needle hub are fixed, the needle tube may be inserted into the needle hub and the needle tube and the needle hub may be bonded, for example, with a thermosetting adhesive.

In the first embodiment, the resistance to removal of the distal end needle tip protection cap 84 is greater than the resistance to removal of the proximal end needle tip protection cap 86, but this configuration is not essential. In the first embodiment, the confirmation seal 100 is provided across both needle tip protection caps 84, 86, but this configuration is also not essential, and the confirmation seal may simply be provided across one of the needle tip protection caps and the mounting portion on the protector body. The needle tip protection caps 170, 172 and confirmation seal 182 in the second embodiment may have a configuration similar to that of the first embodiment.

In the collar member 134 in the second embodiment, the axial dimension c from the tip end face of the abutment portion 148 to the base end face of each protrusion 54 is set to be larger (a<c) than the axial dimension a of each locking piece 164, but the axial dimension a may be set to be equal to or larger than the axial dimension c (c≦a). However, it is preferable to set the axial dimension a of the locking piece to be relatively small so that the mounting portion can easily overcome each locking piece when it is extrapolated onto the collar member.

10 Blood collection needle 12 Needle tube 14 Needle hub 16 Needle tip 18 Protector 20 Needle tip 22, 24 Blade surface 26 Reservoir portion 28 Male thread 30 Fixing portion 32 Cylindrical portion 34 Protruding portion 35 Base portion 36 Sleeve 38 Collar member 40 Protector body 42, 42a, 42b Inner hole 44, 44a, 44b Circumferential wall 46 Small diameter cylindrical portion 48 Step portion 50 Large diameter cylindrical portion 51 Rib 52 Abutment portion 54 Protrusion 56 Rib 58 Protruding rib 60 Cover portion 62 Hinge portion 64 Mounting portion 66 Groove bottom wall portion 68 Side wall portion 70 Side opening 72 Base end side opening portion 74 Tip side wall portion 76 Engagement portion 78 Connecting arm 80 Pressing arm 82 Support portion 84, 86 Needle tip protection cap 88 Seal attachment portion 90 Inner insertion fixing portion 92 Protrusion 94 Cap fitting portion 96 Seal attachment portion (outer insertion fixing portion)
97 Rib 98 Cap fitting portion 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 120 Female thread 122 Cylindrical portion 124 Holding claw portion 130 Blood collection needle (second embodiment)
132 Protector 134 Collar member 136 Protector body 138 Inner peripheral side tubular portion 140 Outer peripheral side tubular portion 142 Anti-rotation rib 144 Curved surface 146 Inclined surface 148 Contact portion 149 Rib 150 Anti-slip portion 152 Curved surface 154 Slit 156 Support wall portion 158, 160 Curved surface 162 Press-contact rib 164 Locking piece 166 Curved surface 167 Storage space 168 Mounting portion 170, 172 Needle tip protection cap 174 Seal attachment portion 176 Inserted and fixed portion 178 Rib 180 Seal attachment portion (externally inserted and fixed portion)
182 Confirmation seal 184a, 184b Cut

Claims (7)

1. A blood collection needle having a protector attached to a needle hub fixed to a needle tube, the protector covering the needle tip after use,
   The needle hub is bonded to the needle tube,
   A collar member is fixed to the outer peripheral surface of the needle hub,
   A blood collection needle in which a protector body made of synthetic resin and an attachment portion are integrally formed with a cover portion covering the needle tip of the needle tube via a bendable hinge portion, and the attachment portion is attached in an externally inserted state to the collar member.
2. The blood collection needle according to claim 1, wherein the mounting portion of the protector body is fitted tightly around the collar member and is attached so as to be rotatable in the circumferential direction.
3. a total axial dimension of an exposed portion of the collar member exposed on an outer circumferential surface on both axial sides of the mounting portion when a needle tip protection cap covering the needle tube is attached is larger than an axial dimension of an exposed portion of the outer circumferential surface of the mounting portion,
   3. The blood collection needle according to claim 2, wherein the axial dimension of the exposed portion of the outer circumferential surface of said attachment portion is not less than 2 mm and not more than 5 mm.
4. The blood collection needle according to any one of claims 1 to 3, in which the needle hub is adhered to the needle tube by a thermosetting adhesive.
5. The blood collection needle according to any one of claims 1 to 4, wherein the collar member is provided with cylindrical cap fitting portions on both axial sides of the support portion to which the mounting portion of the protector body is attached in an externally inserted state, to which a needle tip protection cap is removably attached.
6. The blood collection needle according to any one of claims 1 to 5, wherein the collar member is fixed to the needle hub by adhesive or ultrasonic welding.
7. A needle tip protection cap is removably attached to each of both axial sides of the collar member, and a confirmation seal is attached to the outer circumferential surface of the attachment portion, the confirmation seal extending to the outer circumferential surface of each of the needle tip protection caps on both axial sides,
   The blood collection needle according to any one of claims 1 to 6, wherein the removal resistance of the needle tip protection cap that protects the needle tip on the puncture side of the needle tube is set to be greater than the removal resistance of the needle tip protection cap that protects the needle tip on the opposite blood collection tube side.

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