Needle assembly

Abstract

Provided is an improved needle assembly with a new structure, the needle assembly ensuring handleability in a single hand when a puncture needle is punctured and withdrawn.　The present invention provides a needle assembly 10 in which: a pair of variable plate-shaped parts 40a, 40b is disposed such that the variable plate-shaped parts 40a, 40b face each other and that the variable plate-shaped parts 40a, 40b can be bilaterally bent at upper and lower parts 70, 68 on both sides; a flex part 46 that can be bent and deformed is provided at the middle part in the height direction of each variable plate-shaped part 40; a needle hub 24 of a puncture needle 12 is held at the upper parts 70, 70 of the variable plate-shaped parts 40a, 40b, and the variable plate-shaped parts 40a, 40b can thereby be stretchably / contractibly deformed in the vertical direction, which is the puncture direction of the puncture needle 12; the position of a needle tip 16 of the puncture needle 12 is located at a puncture position at which puncture can be performed in the state where the variable plate-shaped parts 40a, 40b have contracted, and the position of the needle tip 16 is located at a needle withdrawal position at which the needle is withdrawn in the state where the variable plate-shaped parts 40a, 40b have stretched; and the lower parts 68, 68 of the variable plate-shaped parts 40a, 40b are connected via a bottom plate part 54 superposed on the skin A of a patient.

Description

needle assembly

[0001] The present invention relates to a needle assembly having a puncture needle for puncturing, for example, a subcutaneously implantable port.

[0002] Needle assemblies used to puncture a subcutaneously implantable port implanted under the skin of a patient's chest, upper arm, etc. have been known for some time. The needle assembly includes a hollow puncture needle that punctures a septum (a puncture portion formed of compressed silicone rubber or the like) of the subcutaneously implantable port.

[0003] Meanwhile, needle assemblies have also been proposed that can be operated with one hand, as in JP 2002-529156 A (Patent Document 1). A needle assembly that can be operated with one hand makes it easier for a patient to remove the needle assembly from a subcutaneously implantable port by themselves.

[0004] Special Publication No. 2002-529156

[0005] However, after investigations by the present inventors, it was found that the needle assembly equipped with the hypodermic needle safety enclosure container disclosed in Patent Document 1 still had areas that needed improvement in terms of operability and safety during puncture, placement, and removal of the needle.

[0006] The problem to be solved by the present invention is to provide a needle assembly of a novel structure that addresses the remaining issues inherent in conventional needle assemblies, such as ease of use and safety during puncture, placement, and removal.

[0007] The following describes preferred embodiments for understanding the present invention, but the embodiments described below are merely examples and may be appropriately combined with one another. Multiple components described in each embodiment may be recognized and employed independently to the greatest extent possible, and may also be appropriately combined with any of the components described in other embodiments. Accordingly, the present invention is not limited to the embodiments described below, and various other embodiments may be realized.

[0008] In the first aspect, a pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a locking mechanism that holds the pair of variable plate-shaped parts in an extended state is provided on the opposing inner surfaces of the pair of variable plate-shaped parts.

[0009] With the needle assembly constructed according to this aspect, after the puncture needle is withdrawn, the pair of variable plate-shaped members are held in an extended state by the locking mechanism, thereby holding the tip of the puncture needle in the withdrawn position and preventing accidental puncture with the needle tip. In addition, because the locking mechanism is provided on the opposing inner surfaces of the pair of variable plate-shaped members, it is difficult to touch the locking mechanism.

[0010] In a second aspect, in the needle assembly described in the first aspect, the locking mechanism is provided on the variable plate-shaped portion above the bent portion.

[0011] In a needle assembly constructed in accordance with this aspect, the locking mechanism provided on the opposing inner surfaces of a pair of variable plate-shaped portions is located away from the needle tip, making it easy to secure space for the locking mechanism even when, for example, a protective structure for the needle tip is provided.

[0012] In a third aspect, a pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, while the lower parts of the pair of variable plate-shaped parts are connected to each other via a base plate part that is placed on top of the patient's skin.

[0013] With the needle assembly constructed according to this aspect, the puncture needle can be withdrawn by the extension and deformation of the pair of variable plate-shaped portions, and the puncture needle can be withdrawn, for example, with one hand. In this way, since the puncture and withdrawal operations can be easily performed with one hand, for example, the patient himself or herself can withdraw the puncture needle from the subcutaneously implantable port.

[0014] The pair of variable plate-like portions are connected via a bottom plate portion that is adapted to be placed over the patient's skin. This allows the needle assembly to come into surface contact with the patient's skin via the bottom plate portion, increasing the contact area between the needle assembly and the patient's skin and reducing contact pressure. This reduces pain and discomfort caused by contact with the patient's skin when the needle assembly is left in a puncture state, and also suppresses tilting of the needle assembly during taping work after placement or during needle removal, thereby reducing pain and improving work efficiency.

[0015] Furthermore, since the deformation and displacement of the bottom plate portion is less than that of the pair of variable plate portions when the pair of variable plate portions expands and contracts, it is easy to ensure stable contact with the patient's skin.

[0016] In a fourth aspect, in the needle assembly described in the third aspect, the bottom plate portion is provided with a protrusion that protrudes outward beyond the variable plate portion in a longitudinal direction parallel to the bending axis of the variable plate portion.

[0017] In the needle assembly constructed according to this aspect, the base plate is provided with a protruding portion, which increases the contact area between the base plate and the patient's skin, thereby more effectively reducing pain due to lower contact pressure and improving the efficiency of the fixation process by suppressing wobbling.

[0018] A fifth aspect is the needle assembly according to the fourth aspect, wherein the bottom plate portion is wider at the protruding portion.

[0019] In the needle assembly constructed according to this aspect, the base plate is wider at the protruding portion that protrudes outward more than the pair of variable plate portions, thereby ensuring a larger area of ​​the base plate while minimizing the effect of the base plate on the size of the connecting portion of the pair of variable plate portions. Furthermore, because the length of the contact surface between the base plate and the patient's skin is longer in the width direction of the protruding portion, a large resistance force against tilting of the needle assembly can be obtained, thereby suppressing tilting of the needle assembly.

[0020] A sixth aspect is a needle assembly according to the fourth or fifth aspect, wherein the protrusion is arranged opposite the needle hub, and the protrusion is provided with a support portion that protrudes toward the needle hub.

[0021] In the needle assembly constructed according to this aspect, when the pair of variable plate-shaped sections are in the contracted state, the support section provided on the protruding section abuts against the needle hub, thereby restricting movement of the needle hub, such as tilting, and thus suppressing unwanted movement of the needle hub, such as shaking of the needle tip during puncture.

[0022] In a seventh aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bending part that can be bent is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, while the needle hub has a connecting part that extends in a direction intersecting the puncture direction of the puncture needle, and the puncture needle protrudes in the puncture direction from partway along the length of the connecting part, and the upper parts of the pair of variable plate-shaped parts are attached to each side of the connecting part, longitudinally sandwiching the protruding part of the puncture needle.

[0023] In a needle assembly constructed according to this aspect, the force generated by the expansion and contraction of the pair of variable plate-shaped members is input to the needle hub on both sides of the portion of the puncture needle protruding from the needle hub. This reduces the moment acting on the needle hub when, for example, the pair of variable plate-shaped members are expanded and deformed to withdraw the needle, making it less likely for the needle hub to tilt, and the portion of the puncture needle protruding from the needle hub when withdrawn from the patient is less likely to tilt due to the tilting of the needle hub. This allows for smooth needle withdrawal and reduces pain caused by the tilting of the puncture needle during insertion.

[0024] In an eighth aspect, in the needle assembly described in the seventh aspect, the upper portions of the pair of variable plate-shaped portions each have a fitting portion, and the connecting portion is rotatably fitted to each fitting portion of the pair of variable plate-shaped portions, thereby allowing the pair of variable plate-shaped portions to bend relative to each other.

[0025] With the needle assembly constructed according to this aspect, the needle hub and the upper portions of the pair of variable plate-like portions can be easily connected by fitting the connecting portion with the pair of fitting portions. Furthermore, because the connecting portion is fitted to the pair of fitting portions in a manner that allows bending of the pair of variable plate-like portions at the bending portion, the expansion and contraction deformation of the pair of variable plate-like portions is not hindered by the fitting of the connecting portion with the pair of fitting portions.

[0026] In a ninth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part in the height direction of each of the variable plate-shaped parts, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a gripping piece is provided to be gripped when the puncture needle is inserted, and the gripping piece is located between both ends of the variable plate-shaped part in the length direction parallel to the bending axis of the variable plate-shaped part.

[0027] With a needle assembly constructed according to this aspect, when the gripping piece is gripped and puncture is performed, the force in the puncture direction exerted on the gripping piece is unlikely to cause an unnecessary moment to act on the puncture needle, making it difficult for the puncture needle to tilt, thereby achieving smooth puncture. In particular, if the gripping piece and the needle tip of the puncture needle are aligned in the puncture direction, the efficiency of the force in the puncture direction from the gripping piece to the puncture needle is increased, achieving smoother puncture.

[0028] In a tenth aspect, in the needle assembly described in the ninth aspect, the gripping piece extends from the variable plate-like portion, and a movable portion is provided that allows the gripping piece to bend relative to the variable plate-like portion.

[0029] In the needle assembly constructed according to this aspect, the gripping piece extends from the variable plate-like portion, making it easy to provide a movable portion at the connection between the gripping piece and the variable plate-like portion. Furthermore, during puncture, the movable portion moves the gripping piece away from the variable plate-like portion, allowing the gripping piece to be easily grasped by pinching it with the fingertips. Furthermore, for example, when placing the needle assembly after puncture, the movable portion can move the gripping piece closer to the variable plate-like portion, preventing the gripping piece from protruding, making it easier to secure the needle assembly with taping or the like.

[0030] In an eleventh aspect, a pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a protective part is provided to prevent the needle tip of the puncture needle from protruding outward when the pair of variable plate-shaped parts are in an extended state.

[0031] With the needle assembly constructed according to this aspect, when the pair of variable plate-shaped sections are in the extended state, the tip of the puncture needle can be prevented from protruding outward from between the pair of variable plate-shaped sections, making it less likely that the needle tip will be accidentally touched, and reducing the risk of accidental punctures.

[0032] In the twelfth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bent part that can be bent and deformed is provided in the middle part of the height of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, while the bent part of the variable plate-shaped part is an input bent part that is pressed when the variable plate-shaped part is extended and deformed, and the variable plate-shaped part is thicker towards the input bent part.

[0033] In the needle assembly constructed according to this aspect, the variable plate-shaped portion is thickened toward the input bending portion, which increases the contact area of ​​the input bending portion with the fingers, etc. This allows for stable application of force to the input bending portion and reduces pain caused by the input bending portion digging into the fingers, etc. when applying force.

[0034] In a thirteenth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part in the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, while the variable plate-shaped part has a plurality of such bending parts, and the space between two adjacent bending parts in the height direction forms an input plate part that is pressed when the variable plate-shaped part is extended and deformed.

[0035] In the needle assembly constructed according to this aspect, the portion to which force is applied by fingers, etc. when the pair of variable plate-shaped members is extended and deformed is the plate-shaped input plate member, which increases the contact area with the fingers, etc. Therefore, force can be applied to the input plate member stably, and pain caused by the input plate member digging into the fingers, etc. when force is applied can be reduced.

[0036] In a fourteenth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part in the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a fixed piece that is superimposed on and fixed to the patient's skin is provided so as to protrude outward from the pair of variable plate-shaped parts in the length direction parallel to the bending axis of the variable plate-shaped parts.

[0037] With a needle assembly constructed according to this aspect, by fixing the fixed piece to the patient's skin with medical tape or the like, the needle assembly is left in a more stably fixed state on the patient's body surface than, for example, when the fixed piece is simply fixed with medical tape or the like so as to cover the pair of variable plate-shaped parts. Furthermore, because the fixed piece protrudes outward in the width direction beyond the pair of variable plate-shaped parts, the pair of variable plate-shaped parts are less likely to get in the way when fixing the fixed piece with medical tape or the like.

[0038] In a fifteenth aspect, the needle assembly according to any one of the first to fourteenth aspects is provided with an elastically deformable buffer on a surface that is superimposed in contact with the patient's skin.

[0039] With the needle assembly constructed according to this aspect, a buffer is placed between the needle assembly and the patient's skin, thereby reducing pain and discomfort caused by contact with the needle assembly.

[0040] A sixteenth aspect is a needle assembly according to any one of the first to fifteenth aspects, wherein the needle tip of the puncture needle is housed between the pair of variable plate-shaped portions when the pair of variable plate-shaped portions is in an extended state.

[0041] With the needle assembly constructed according to this aspect, the tip of the puncture needle is housed between the pair of variable plate-shaped parts by extending and deforming the pair of variable plate-shaped parts to remove the puncture needle, thereby preventing the tip of the removed puncture needle from being exposed and preventing accidental punctures.

[0042] In a seventeenth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part in the height direction of each of the variable plate-shaped parts, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a gripping piece is provided to be gripped when the puncture needle is inserted, and the puncture needle extends in the puncture direction at a position that overlaps with the gripping piece in the bending axis direction of the variable plate-shaped parts.

[0043] With a needle assembly constructed in accordance with this aspect, for example, when the variable plate-shaped portion is expanded or contracted by input to the gripping piece to move the tip of the puncture needle to the puncture position or the needle removal position, the force from the gripping piece is transmitted in a balanced manner to the tip of the puncture needle, which has the needle tip, while the gripping piece is held with the fingers, allowing for smooth puncture and removal without tilting the puncture needle, etc.

[0044] In the eighteenth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part in the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, while the lower parts of the pair of variable plate-shaped parts are connected to each other via a base plate part that is superimposed on the patient's skin, and a position regulating part is provided that limits the relative displacement of the needle hub and the bottom plate part when the needle tip is in the puncture position.

[0045] With a needle assembly constructed according to this aspect, for example, the position restriction portion restricts the relative displacement between the needle hub and the base plate portion in the direction in which the pair of variable plate-shaped portions oppose each other, thereby suppressing the wobble of the needle tip of the puncture needle.Furthermore, for example, by restricting the relative displacement between the needle hub and the base plate portion in the direction in which they move away from each other, the needle tip of the puncture needle can be held in the puncture position during puncture, preventing unintentional removal of the puncture needle (release of the puncture state), etc.

[0046] In a 19th aspect, in the needle assembly described in the 18th aspect, the bottom plate portion is provided with a needle insertion hole through which the puncture needle is inserted when the needle tip of the puncture needle is in the puncture position, and an outer insertion portion is provided that protrudes from the periphery of the needle insertion hole toward the needle hub, and the needle hub is provided with an insertion portion that extends toward the bottom plate portion, and the position regulating portion that limits the relative displacement between the needle hub and the bottom plate portion in at least one of the direction of separation between the needle hub and the bottom plate portion and the direction in which the pair of variable plate-shaped portions face each other is formed by inserting the insertion portion into the outer insertion portion.

[0047] With a needle assembly constructed in accordance with this aspect, even if the needle insertion hole is sufficiently large in diameter for the puncture needle, the relative displacement between the needle hub and the bottom plate can be limited in the direction of separation from each other and in the direction in which the pair of variable plate-shaped portions face each other by inserting the insertion portion of the needle hub into the outer insertion portion of the bottom plate while the needle tip is in the puncture position.

[0048] In a twentieth aspect, a pair of variable plate-shaped parts are arranged opposite each other and can bend relative to each other at both upper and lower sides, and each variable plate-shaped part has a bending part that can be bent and deformed in the middle part in the height direction, and the upper parts of the pair of variable plate-shaped parts are provided with groove-shaped fitting parts that are attached to the outer peripheral surface of the needle hub of the puncture needle, and the fitting parts are able to slide circumferentially relative to the needle hub, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, and when the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, and a stopper protrusion is provided on the outer peripheral surface of the fitting part of at least one of the variable plate-shaped parts, which engages with the other variable plate-shaped part to prevent the needle tip from moving from the needle withdrawal position to the puncture position.

[0049] In the needle assembly constructed according to this aspect, the stopper projection is engaged with the other variable plate portion, preventing the fitting portion from sliding relative to the needle hub, and thus preventing the pair of variable plate portions from transitioning from the extended state to the contracted state, thereby preventing the puncture needle from being re-exposed and capable of puncturing after being withdrawn.

[0050] According to the present invention, it is possible to provide an improved needle assembly that ensures easy one-handed operability when inserting and withdrawing the puncture needle.

[0051] 1 is a perspective view of a needle assembly according to a first embodiment of the present invention, showing a contracted state in which the tip of the puncture needle is at the puncture position; FIG. 1 is a front view of the needle assembly shown in FIG. 1; 21 is a front view of the needle assembly shown in FIG. 16 during puncture, showing a perspective view of the needle assembly shown in FIG. 16, showing an extended state where the tip of the puncture needle is at the needle-removal position;

[0052] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0053] 1 to 5 show a needle assembly 10 in a retracted state as a first embodiment of the present invention. The needle assembly 10 has a structure in which a puncture needle 12 is attached to a wing member 14. In the following description, as a general rule, the up-down direction refers to the up-down direction in FIG. 2, which corresponds to the puncture direction and the needle withdrawal direction, the left-right direction refers to the left-right direction in FIG. 2, and the front-rear direction refers to the left-right direction in FIG. 3. Note that the directions defined here are set for convenience, and for example, the up-down direction does not necessarily coincide with the vertical up-down direction when the needle assembly 10 is in use.

[0054] The puncture needle 12 is a hollow metal needle with a sharp needle tip 16 at its tip. In this embodiment, the puncture needle 12 is a Huber needle that punctures a septum of a subcutaneously implantable port (not shown). That is, the end of the puncture needle 12 on the needle tip 16 side of the lumen opens rearward (to the right in FIG. 5 ), perpendicular to the puncture direction, to prevent coring (piercing the septum by the puncture needle 12) when puncturing the septum. However, the puncture needle may also be a hollow needle that opens in the puncture direction, like a normal injection needle.

[0055] The puncture needle 12 extends in an L-shape overall, and includes a curved portion 18 that is curved in a quarter-circular arc (an arc with a central angle of 90°). The distal end of the puncture needle 12 from the curved portion 18 forms a tip portion 20 that extends in the vertical direction, and the proximal end of the puncture needle 12 from the curved portion 18 forms a base portion 22 that extends in the front-to-rear direction substantially perpendicular to the puncture direction.

[0056] A needle hub 24 is fixed to the base 22 of the puncture needle 12. The needle hub 24 is made of a hard resin or the like and has a generally cylindrical shape. The needle hub 24 has a connecting portion 25 that extends in a direction intersecting the puncture direction of the puncture needle 12. The connecting portion 25 integrally includes a first connecting portion 26 fixed to the base 22 of the puncture needle 12, a second connecting portion 28 that protrudes forward beyond the puncture needle 12, and a connecting portion 30 that connects the first connecting portion 26 and the second connecting portion 28.

[0057] The first connecting part 26 is generally cylindrical, and the base 22 of the puncture needle 12 is inserted into and fixed to the central hole. A flange-shaped part 32 that protrudes outward and extends circumferentially from the front end of the outer circumferential surface of the first connecting part 26. Therefore, the outer circumferential surface of the first connecting part 26 has a smaller diameter rearward of the flange-shaped part 32.

[0058] The connecting portion 30 is provided continuously in front of the first connecting portion 26, and is generally cylindrical with an axial length shorter than that of the first connecting portion 26. The curved portion 18 of the puncture needle 12, which extends forward beyond the first connecting portion 26, penetrates the lower portion of the connecting portion 30 and protrudes downward. The tip portion 20 of the puncture needle 12 extends downward below the connecting portion 30, and the needle tip 16 is provided at the lower end of the tip portion 20. In other words, the needle tip 16 of the puncture needle 12 is located below the connecting portion 30, which is provided midway through the connecting portion 25, and is located between the first connecting portion 26 and the second connecting portion 28 in the front-to-rear direction.

[0059] The second connecting portion 28 is provided continuously in front of the connecting portion 30, and has a generally cylindrical shape similar to the first connecting portion 26. A flange-shaped portion 32 similar to the first connecting portion 26 is provided on each of the axial ends of the second connecting portion 28, and the outer circumferential surface of the second connecting portion 28 has a smaller diameter between the flange-shaped portions 32, 32 in the axial direction.

[0060] The second connecting portion 28 has a slit 34. The slit 34 penetrates radially from the radial center of the second connecting portion 28 downward, which is the protruding direction of the tip 20 of the puncture needle 12, and extends continuously over the entire length in the front-to-rear axial direction. The slit 34 reaches the connecting portion 30, and the upper end of the slit 34 is continuous with the center hole of the first connecting portion 26 into which the base 22 of the puncture needle 12 is inserted, and the curved portion 18 of the puncture needle 12 extends within the slit 34. Therefore, for example, the puncture needle 12 can be inserted from the front into the slit 34 relative to a needle hub 24 formed separately from the puncture needle 12, and the base 22 of the puncture needle 12 can be inserted into the center hole of the first connecting portion 26, and the base 22 and the first connecting portion 26 can be fixed by means of welding, adhesive, or the like. However, for example, the puncture needle 12 may be inserted when the needle hub 24 is molded, and the needle hub 24 may be formed in a state where it is fixed to the base 22 of the puncture needle 12 .

[0061] The needle hub 24 also has a tube connection portion 36 integrally formed therewith, rearward of the first connecting portion 26. The tube connection portion 36 has larger inner and outer diameters than the first connecting portion 26, and one end of a tube 38 is inserted and fixed thereto. The other end of the tube 38 is connected to a drug solution bag or infusion bag (not shown), for example, via a connector or another tube, and the drug solution or infusion is supplied to the lumen of the puncture needle 12 through the tube 38. A clamp that switches between communication and blocking of the lumen of the tube 38 may also be provided midway along the tube 38. Note that in the drawings, the tube 38 is shown imaginarily by a two-dot chain line.

[0062] The needle hub 24 is attached to the wing member 14. The wing member 14 is made of a hard resin, but by providing a partial linear thin-walled portion, it has the toughness to allow bending (bending) at the thin-walled portion. The wing member 14 has a pair of variable plate-like portions 40a, 40b as shown in Figures 1 to 3.

[0063] The pair of variable plate-like portions 40a, 40b are disposed opposite each other with one surface facing each other, and are mutually bendable at their upper and lower portions. Furthermore, each of the pair of variable plate-like portions 40a, 40b is provided with a first bent portion 46 at a corresponding intermediate portion in the height direction. The pair of variable plate-like portions 40a, 40b are configured to bend and deform at both upper and lower sides and at the intermediate portion in the height direction, causing the intermediate portions of the pair of variable plate-like portions 40a, 40b to move toward and away from each other, thereby expanding and contracting in the vertical direction and allowing deformation similar to that of a pantograph.

[0064] More specifically, the variable plate portion 40 has a structure in which a first plate portion 42 and a second plate portion 44 are connected by a first bending portion 46 that serves as a bendable input bending portion. The first plate portion 42 and the second plate portion 44 gradually become thicker toward the first bending portion 46, and the area of ​​each end face of the first plate portion 42 and the second plate portion 44 on the first bending portion 46 side is increased. The first bending portion 46 is a thin-walled portion that extends linearly in the longitudinal direction between the first plate portion 42 and the second plate portion 44. The first bending portion 46 is integrally formed with the first plate portion 42 and the second plate portion 44, and its thin wall allows bending deformation. Note that in this embodiment, the variable plate portion 40 is configured to deform in a hinged manner so as to fold around a bending axis located on the first bending portion 46. However, for example, the variable plate portion 40 may be bent in a curved shape around a bending axis that is offset from the variable plate portion 40 in the plate thickness direction.

[0065] The second plate portion 44 of one variable plate portion 40a has a pair of locking portions 48a, 48a, and the second plate portion 44 of the other variable plate portion 40b has a pair of locking portions 48b, 48b. The locking portions 48a, 48a protrude in the thickness direction of the second plate portion 44 and are provided opposite each other in the front-to-rear direction, which is the width direction of the second plate portion 44, and have a structure in which claws are provided at the protruding tip portions that protrude inward in the opposing direction. The locking portions 48b, 48b protrude in the thickness direction of the second plate portion 44 and are provided opposite each other in the width direction of the second plate portion 44, and have a structure in which claws are provided at the protruding tip portions that protrude outward in the opposing direction. The distance between the locking portions 48a, 48a is greater than the distance between the locking portions 48b, 48b, so that the locking portions 48b, 48b can be inserted between the opposing locking portions 48a, 48a. The locking portions 48 a, 48 a and the locking portions 48 b, 48 b are provided to protrude from the opposing inner surfaces of a pair of variable plate-shaped portions 40 a, 40 b arranged opposite each other. Note that a pair of through holes 52, 52 that are marks from the mold used to form the locking portions 48 a, 48 a or the locking portions 48 b, 48 b are formed in the second plate portion 44, and the locking portions 48 a, 48 a are provided on the front and rear outer opening edge portions of the through holes 52, 52 in one second plate portion 44, and the locking portions 48 b, 48 b are provided on the front and rear inner opening edge portions of the through holes 52, 52 in the other second plate portion 44.

[0066] As shown in Figures 1 and 4, the first plate portion 42 of the variable plate-like section 40 is connected to a bottom plate portion 54 at its end (lower end) opposite the first bent portion 46 serving as an input bent portion. The bottom plate portion 54 is generally flat and has a lower surface that extends generally perpendicular to the up-down direction, including the puncture direction. A needle insertion hole 56 is formed in the center of the bottom plate portion 54, penetrating vertically and allowing the puncture needle 12 to be inserted therethrough. The bottom plate portion 54 may be uneven or curved, for example, taking into account the unevenness or curvature of the patient's body surface at the site where the needle assembly 10 will be punctured.

[0067] A protective tube portion 58 is provided as a protective portion that protrudes from the upper surface at the center of the bottom plate portion 54. The protective tube portion 58 is cylindrical and protrudes upward around the needle insertion hole 56, allowing the puncture needle 12 to be inserted therethrough. The upper surface of the protective tube portion 58 is curved in a concave shape that corresponds to the outer peripheral surface of the tube connection portion 36 of the needle hub 24.

[0068] The bottom plate portion 54 has protruding portions 60, 60 at both ends in the front-rear direction that protrude outward beyond the variable plate-shaped portion 40 in the longitudinal direction (front-rear direction) parallel to the bending axis. The protruding portion 60 has widened portions 62, 62 that protrude further to both sides in the left-right direction (i.e., width direction), making it wider in the left-right direction than the central portion of the bottom plate portion 54 connected to the variable plate-shaped portion 40. The protruding tips of the widened portions 62, 62 are approximately semicircular arc-shaped and have no corners. The rear protruding portion 60 has a support portion 64 that protrudes from its upper surface. The support portion 64 protrudes upward from the center of the protruding portion 60 in the left-right direction and has a generally rectangular block shape. The support portion 64 is located below the tube connection portion 36 of the needle hub 24 and protrudes toward the tube connection portion 36, and its upper surface, which is the protruding tip surface, is a concave curved surface that corresponds to the outer peripheral surface of the tube connection portion 36.

[0069] A sheet-like buffer 66 having an outline substantially corresponding to that of the bottom plate 54 is superimposed on the underside of the bottom plate 54. The buffer 66 is formed of a resin elastomer, rubber elastic material, or the like, and is more flexible than the bottom plate 54 and easily deforms elastically, thereby providing a buffering effect upon contact. The buffer 66 is preferably fixed to the underside of the bottom plate 54. The needle insertion hole 56 of the bottom plate 54 is formed through the buffer 66. Note that the buffer 66 is not essential and can be omitted. Furthermore, for example, a buffer can also be provided on the second plate 44 to prevent pain or other discomfort from occurring to the patient when the second plate 44 comes into contact with the patient's skin A. Note that the buffer 66 is not shown in FIG. 4 in order to illustrate the shape of the bottom plate 54.

[0070] The first plate portion 42 of the variable plate member 40 is bendably connected to the bottom plate portion 54, and the connecting portion between the first plate portion 42 and the bottom plate portion 54 is a second bent portion 68 serving as a lower portion. Like the first bent portion 46, the second bent portion 68 is a thin portion extending linearly in the front-to-rear direction, and is formed integrally with the first plate portion 42 and the bottom plate portion 54. Due to its thin wall, the second bent portion 68 is allowed to bend. A pair of variable plate portions 40a, 40b is provided on both the left and right sides of the bottom plate portion 54, and each pair of variable plate portions 40a, 40b is provided continuously on one side of the bottom plate portion 54. As a result, the pair of variable plate portions 40a, 40b are connected to each other at their lower ends via the bottom plate portion 54, and as shown in FIGS. 6 and 7 , the blade member 14 is integrally provided with the pair of variable plate portions 40a, 40b and the bottom plate portion 54.

[0071] One end of the variable plate-shaped portion 40 is connected to the needle hub 24 as shown in FIGS. 1 and 2 . Specifically, a fitting groove 70 is provided as a fitting portion on the end (upper portion) of the second plate portion 44 of the variable plate-shaped portion 40 opposite the first plate portion 42, as shown in FIGS. 6 and 7 . The fitting groove 70 extends in the front-rear direction with a C-shaped annular cross section that is a major arc of more than half the circumference. The front-rear length of the fitting groove 70 is shorter than half the front-rear length of the second plate portion 44, and its deformation rigidity is lower than that of the second plate portion 44, allowing the opening to expand due to elastic bending deformation. The fitting groove 70 is provided in one variable plate-shaped portion 40a so as to be biased rearward, and in the other variable plate-shaped portion 40b so as to be biased forward.

[0072] The first connecting portion 26 of the needle hub 24 is fitted into the fitting groove 70 of one variable plate-shaped portion 40a, and the second connecting portion 28 of the needle hub 24 is fitted into the fitting groove 70 of the other variable plate-shaped portion 40b, thereby attaching one end of the pair of variable plate-shaped portions 40a, 40b to the needle hub 24. The fitting groove 70 of one variable plate-shaped portion 40a is attached to the first connecting portion 26 behind the tip 20 of the puncture needle 12, and the fitting groove 70 of the other variable plate-shaped portion 40b is attached to the second connecting portion 28 ahead of the tip 20 of the puncture needle 12. In short, the pair of variable plate-shaped portions 40a, 40b are attached to the connecting portion 25 of the needle hub 24 on each side of the connecting portion 30, which is the protruding portion of the puncture needle 12 on the needle hub 24, in the front-to-rear direction. The needle hub 24 is rotatable circumferentially relative to the mating grooves 70, 70 of the pair of variable plate-shaped portions 40a, 40b, and the second plate portions 44, 44 of the pair of variable plate-shaped portions 40a, 40b are connected in a state in which angular changes (tilting around the needle hub 24 as the central axis) are permitted relative to the needle hub 24.

[0073] The fitting groove 70 of one variable plate portion 40a is positioned between the flange portion 32 of the first connecting portion 26 and the tube connecting portion 36, thereby positioning the variable plate portion 40a and the needle hub 24 in the front-to-rear direction. Similarly, the fitting groove 70 of the other variable plate portion 40b is positioned between the flange portions 32, 32 of the second connecting portion 28, thereby positioning the variable plate portion 40b and the needle hub 24 in the front-to-rear direction.

[0074] The fitting groove 70 has one circumferential end continuous with the second plate portion 44 and the other end continuous with the gripping piece 72. The gripping piece 72 is plate-shaped and is provided integrally with the variable plate portion 40, extending from the fitting groove 70 that constitutes the end of the variable plate portion 40. The length of the gripping piece 72 in the front-to-rear direction is equal to or less than the length of the variable plate portion 40 in the front-to-rear direction, and the gripping piece 72 is located between the front and rear ends of the variable plate portion 40 in the front-to-rear direction without protruding outward in the front-to-rear direction relative to the variable plate portion 40. The gripping piece 72 includes a connecting base 74 having the same front-to-rear length as the fitting groove 70, and a gripping tip 76 that is integrally connected to the tip of the connecting base 74 and has the same front-to-rear length as the second plate portion 44. The connection portion between the connection base 74 and the grip tip 76 is thinned linearly and extends in the width direction, and this thinned portion serves as a movable portion 78 that allows the grip tip 76 to bend relative to the connection base 74. The connection base 74 may be bendable relative to the fitting groove 70, but in this embodiment, bending relative to the fitting groove 70 is not permitted. If bending of the connection base 74 relative to the fitting groove 70 is permitted, the movable portion can be formed by the bendable connection portion between the connection base 74 and the fitting groove 70, and it is not necessary to provide the movable portion 78 midway along the grip piece 72.

[0075] The wing members 14 thus constructed are formed into a plate shape as shown in Figures 6 and 7. Then, by bending the first and second bending portions 46, 68 and fitting the first and second connecting portions 26, 28 of the needle hub 24 into the fitting grooves 70, 70, the wing members 14 are formed into a shape that constitutes the needle assembly 10 in the contracted state shown in Figures 1 to 5. Because the wing members 14 are formed into a plate shape and then bent, the locking portions 48a, 48b and the protective tube portion 58 located between the opposing pair of variable plate-like portions 40a, 40b in the needle assembly 10 can be easily formed.

[0076] In the needle assembly 10 in the contracted state, the tip 20 of the puncture needle 12 passes through the needle insertion hole 56 in the bottom plate portion 54, and the needle tip 16 is positioned at a puncture position where puncture is possible because it protrudes below the bottom plate portion 54 and is exposed to the outside. In the needle assembly 10 in the contracted state, the vertical approach of the needle hub 24 to the bottom plate portion 54 is restricted by the connection portion 30 of the needle hub 24 contacting the upper surface of the protective tube portion 58. This prevents excessive bending of the first bent portion 46, avoids damage to the pair of variable plate-shaped portions 40a, 40b, and holds the ends of the pair of variable plate-shaped portions 40a, 40b on the needle hub 24 side above the first bent portion 46.

[0077] 8, when the needle assembly 10 is in the contracted state, the connecting base 74 of the gripping pieces 72 is overlapped with the variable plate-shaped portion 40 in contact with or slightly spaced apart from the variable plate-shaped portion 40, and the gripping tip portion 76 protrudes upward away from the variable plate-shaped portion 40 due to bending of the movable portion 78. A medical professional then grasps the gripping tip portions 76 of the pair of gripping pieces 72, 72, for example, with the index finger α and thumb β of one hand, and inserts the puncture needle 12 into a patient. Even if an inward force in the left-right direction due to grasping or a downward force in the puncture direction acts on the pair of gripping tip portions 76, 76, the pair of variable plate-shaped portions 40a, 40b does not elongate or deform, and the needle tip 16 of the puncture needle 12 is maintained in a state where it is exposed downward.

[0078] When the needle assembly 10 is inserted into the patient, the buffer 66 is superimposed on the patient's skin A in contact with the patient's skin A, and the bottom plate 54 is superimposed on the patient's skin A in an indirect state of contact via the buffer 66. As a result, the inserted needle assembly 10 is in surface contact with the patient's skin A, and pain and discomfort are reduced by dispersing the contact pressure on the patient's skin A, and wobbling of the needle assembly 10 is prevented by ensuring a large contact area with the patient's skin A. Furthermore, the flexible buffer 66 is interposed between the bottom plate 54 and the patient's skin A, which further reduces the contact pressure on the patient's skin A, thereby further reducing pain and discomfort.

[0079] As shown in Figure 9, the needle assembly 10 that has been inserted into the patient is fixed to the patient's skin A by medical tape 80, 82. That is, the needle assembly 10 is fixed to the patient's skin A by the medical tape 80 that straddles the upper part of the front protrusion 60 in the left-right direction and the medical tape 82 that straddles the upper part of the pair of variable plate-like portions 40a, 40b in the left-right direction. In this manner, in this embodiment, the front protrusion 60 serves as a fixing piece that is fixed to the patient's skin A, and since not only the pair of variable plate-like portions 40a, 40b but also the front protrusion 60 is fixed to the patient's skin A, the needle assembly 10 can be more firmly fixed to the patient's skin A. Furthermore, because the front protrusion 60 overlaps the patient's skin A, it can be more easily fixed with the medical tape 80 than the second plate portions 44, 44 of the pair of variable plate-like portions 40a, 40b, etc., that are positioned away from the patient's skin A. Therefore, after puncturing with the needle assembly 10, the front protrusion 60 can be first simply fixed with medical tape 80, and with the needle assembly 10 temporarily positioned, the pair of variable plate-shaped portions 40a, 40b can be fixed with medical tape 82, which can make the fixing process easier.

[0080] When the variable plate-like portions 40a, 40b are fixed to the patient's skin A with the medical tape 82, the bending of the movable portions 78 causes the gripping tips 76 of the gripping pieces 72 to overlap in a contacting or proximate state with the second plate portions 44. This prevents the gripping tips 76 from protruding, reduces the vertical height of the needle assembly 10, and gives the upper surface of the needle assembly 10 a smooth shape with few protruding portions, thereby increasing the area over which the medical tape 82 adheres to the needle assembly 10 and preventing the needle assembly 10, which is left in a punctured state, from getting in the way.

[0081] When removing the needle assembly 10 that has been punctured from the patient, first, a medical professional, the patient, or the like peels off the medical tapes 80, 82 to release the needle assembly 10 from the patient's skin A. Next, as shown in Figure 2, the medical professional, the patient, or the like places the index finger α and thumb β of one hand against each of the first bent portions 46, 46 of the pair of variable plate-like portions 40a, 40b and applies a force inward to the left and right that moves the first bent portions 46, 46 closer together. This causes the first bent portions 46, 46 and the second bent portions 68, 68 to bend and stretch, and the fitting grooves 70, 70 to slide circumferentially relative to the needle hub 24, causing the pair of variable plate-like portions 40a, 40b to deform into the extended state shown in Figures 10 to 12. In this way, the pair of variable plate-shaped portions 40 a , 40 b are allowed to bend and stretch at the first bent portions 46 , 46 by the bending and stretching of the second bent portions 68 , 68 and the circumferential sliding of the fitting groove portions 70 , 70 relative to the needle hub 24 .

[0082] When the pair of variable plate-shaped portions 40a, 40b are in a contracted state, the first plate portion 42 is inclined upward from the bottom plate portion 54 side toward the first bent portion 46, and the second plate portion 44 is inclined downward from the fitting groove portion 70 side toward the first bent portion 46. As a result, the pair of variable plate-shaped portions 40a, 40b in the contracted state have a generally diamond shape when viewed in the front-to-rear direction. As a result, by applying a force inward to the left and right to the first bent portions 46, 46 of the pair of variable plate-shaped portions 40a, 40b, deformation occurs in each variable plate-shaped portion 40 in a direction that reduces the inclination angle of the first plate portion 42 and the second plate portion 44, and the pair of variable plate-shaped portions 40a, 40b undergo elongation deformation.

[0083] In this embodiment, the first plate portion 42 and the second plate portion 44 are thickened toward the first bent portion 46, which is the input bent portion, and the area of ​​the end faces of the first plate portion 42 and the second plate portion 44 on the first bent portion 46 side that are pressed by the fingers α (β) is increased. This reduces the contact pressure when the first bent portions 46, 46 are pressed by the fingers α, β, reducing pain and discomfort caused by the first bent portions 46, 46 digging into the fingers α, β, and making it easier to perform the operation of extending and deforming the pair of variable plate-shaped portions 40 a, 40 b.

[0084] When the pair of variable plate-shaped portions 40a, 40b are extended and deformed, the needle hub 24 moves upward away from the bottom plate portion 54 that is placed over the patient's skin A. As a result, when the pair of variable plate-shaped portions 40a, 40b are extended, the distance from the needle hub 24 to the patient's skin A becomes longer than the length of the tip portion 20 of the puncture needle 12. As a result, as shown in FIG. 12 , the needle tip 16 of the puncture needle 12 is positioned above the underside of the bottom plate portion 54, and the needle tip 16 is positioned at the withdrawal position where puncture is released and the needle is withdrawn. In this way, by moving the needle tip 16 away from the patient's skin A, the puncture needle 12 that has punctured the patient is withdrawn from the patient. Then, by moving the bottom plate portion 54 away from the patient's skin A, the needle assembly 10 is removed from the patient.

[0085] As shown in Figure 11, the tip 20 of the removed puncture needle 12 is housed between a pair of opposing variable plate-like portions 40a, 40b, which are in an extended state, including the needle tip 16, protecting the needle tip 16 from exposure to the outside. This makes it less likely that the needle tip 16 of the removed puncture needle 12 will be accidentally touched, ensuring excellent safety. The pair of extended variable plate-like portions 40a, 40b have a narrow gap between their opposing surfaces in the left-right direction, so that fingers or the like cannot be inserted. Preferably, the distance between the pair of opposing variable plate-like portions 40a, 40b is set so that when a finger is inserted between the pair of opposing variable plate-like portions 40a, 40b, the fingertip can only be inserted to a position where it will not touch the puncture needle 12.

[0086] 12, the needle tip 16 of the puncture needle 12 housed between the opposing pair of variable plate-shaped portions 40a, 40b is housed in a protective tube portion 58 provided on the bottom plate portion 54. This prevents the needle tip 16 of the removed puncture needle 12 from being exposed, preventing accidental punctures with the needle tip 16.

[0087] In the pair of variable plate-shaped portions 40a, 40b in the extended state, the second plate portions 44, 44 face each other and approach each other in the left-right direction, so that the locking portions 48b, 48b provided on the second plate portion 44 of one variable plate-shaped portion 40b are inserted between the locking portions 48a, 48a provided on the second plate portion 44 of the other variable plate-shaped portion 40a, and the locking portions 48a, 48a and the locking portions 48b, 48b are locked to each other. This forms a locking mechanism 84 that prevents the second plate portions 44, 44 of the pair of variable plate-shaped portions 40a, 40b from separating, and the pair of variable plate-shaped portions 40a, 40b are held in the extended state by the locking mechanism 84. Therefore, the variable plate-shaped portions 40a, 40b in the extended state do not contract and deform, preventing the puncture needle 12 from re-projecting downward, thereby preventing accidental punctures.

[0088] It is to be noted that when a force is applied to the first bending portions 46, 46, which are input bending portions, to extend and deform the pair of variable plate-shaped portions 40a, 40b, it is expected that the input position by the fingers α, β will shift or widen toward the second plate portions 44, 44 as the pair of variable plate-shaped portions 40a, 40b extend. Therefore, the locking portions 48a, 48a and the locking portions 48b, 48b are provided on the second plate portions 44, 44, which are located above the first bending portions 46, 46 and on the opposite side of the puncture direction (the side of the connection end to the needle hub 24). This makes it easier to apply force to the portions where the locking portions 48a, 48a and the locking portions 48b, 48b are provided when the pair of variable plate-shaped portions 40a, 40b are in an extended state, and to press the locking portions 48b, 48b into the space between the opposing locking portions 48a, 48a to form the locking mechanism 84.

[0089] The tip 20 of the puncture needle 12 extending between the opposing second plate portions 44, 44 extends between the opposing locking portions 48a, 48a and between the opposing locking portions 48b, 48b, and passes through the locking mechanism 84 in the up-down direction, and the movement of the tip 20 of the puncture needle 12 in the front-to-rear direction is restricted by the locking mechanism 84. This prevents the tip 20 of the puncture needle 12 from moving out of the gap between the pair of opposing variable plate-shaped portions 40a, 40b and protruding forward or backward, and prevents the needle tip 16 from being exposed to the outside.

[0090] The locking portions 48a, 48a and the locking portions 48b, 48b that make up the locking mechanism 84 are provided on the opposing inner surfaces of the variable plate-shaped portions 40a, 40b, making them difficult to touch with fingers, etc., particularly when the variable plate-shaped portions 40a, 40b are in the extended state. This makes it difficult for the locking mechanism 84 to be released by accidentally touching it, and the locking mechanism 84 can stably maintain the extended state of the variable plate-shaped portions 40a, 40b and protect the needle tip 16.

[0091] 13 to 15 show a needle assembly 90 according to a second embodiment of the present invention. The needle assembly 90 has a structure in which a puncture needle 12 is attached to a wing member 92. In the following description, members and parts that are substantially the same as those in the first embodiment are given the same reference numerals in the figures, and description thereof will be omitted.

[0092] A needle hub 94 is fixed to the base 22 of the puncture needle 12. The needle hub 94 in this embodiment has a connecting portion 96 to which the base 22 of the puncture needle 12 is fixed in an inserted state, and a tube connecting portion 36 that is integrally formed behind the connecting portion 96. The connecting portion 96 has a generally cylindrical shape with a smaller diameter than the tube connecting portion 36, and is provided at its front end with a flange-like portion 32 that protrudes outward.

[0093] The blade member 92 includes a pair of variable plate-like portions 98a, 98b. The variable plate-like portion 98 includes an input plate portion 100 having a generally flat plate shape, with a hub connecting plate portion 102 bendably connected to one side of the input plate portion 100 by a first bend portion 104, and a bottom connecting plate portion 106 bendably connected to the other side of the input plate portion 100 by a second bend portion 108. In other words, the variable plate-like portion 98 has two bend portions 104, 108, with the input plate portion 100 located between the bend portions 104, 108, and the hub connecting plate portion 102 and the bottom connecting plate portion 106 located outside the bend portions 104, 108. Note that in Figures 13 to 15, the pair of variable plate-like portions 98a, 98b are in a contracted state, and the needle tip 16 of the puncture needle 12 is in a puncture position where it can be punctured.

[0094] The hub connecting plate 102 is generally flat and, when the pair of variable plate portions 98a, 98b are in a contracted state, tilts downward toward a first bent portion 104, which is the connecting end with the input plate 100. A fitting portion 110, which has a reduced width, is provided at the end of the hub connecting plate 102 opposite the input plate portion 100. The fitting portion 110 has a generally C-shaped annular groove portion that can fit into the connecting portion 96 of the needle hub 94. When the connecting portion 96 of the needle hub 94 fits into the groove of the fitting portion 110, the needle hub 94 is held by one end of the pair of variable plate portions 98a, 98b, and the variable plate portions 98a, 98b can rotate around the needle hub 94. The fitting portion 110 is provided at the front end of one variable plate portion 98a and at the rear end of the other variable plate portion 98b, and is attached at a position separated in the front-to-rear direction from the connecting portion 96 of the needle hub 94. In this embodiment, the locking portions 48a, 48a and the locking portions 48b, 48b that constitute the locking mechanism are provided on the hub connecting plate portions 102, 102.

[0095] The bottom connecting plate 106 is generally flat and, when the pair of variable plate-shaped portions 98a, 98b are in a contracted state, tilts upward toward a second bent portion 108, which is the connection portion with the input plate 100. A bottom plate 112 is provided at the end of the bottom connecting plate 106 opposite the input plate 100, and is bendable and continuous with a third bent portion 114. The bottom plate 112 of this embodiment has a needle insertion hole 56, through which the puncture needle 12 is inserted, provided at the front end of the front protrusion 60. The needle insertion hole 56 penetrates vertically and opens forward with a width smaller than the outer diameter of the puncture needle 12. The front protrusion 60 of this embodiment is penetrated by the tip 20 of the puncture needle 12 when the needle assembly 90 is in a contracted state during puncture, making it more difficult to fix the front protrusion 60 to the patient's skin A with medical tape than in the first embodiment, and therefore does not need to function as a fixing piece. It is also possible to provide a cylindrical protective tube portion that protrudes upward from the periphery of the needle insertion hole 56 to accommodate the needle tip 16 of the removed puncture needle 12 .

[0096] In this embodiment, the curved portion 18 and tip portion 20 of the puncture needle 12 protrude from the needle hub 94 further forward than the pair of variable plate-shaped portions 98 a, 98 b, and the needle tip 16 is located forward of the pair of variable plate-shaped portions 98 a, 98 b. Because the force exerted on the needle hub 94 during puncture and withdrawal of the puncture needle 12 is applied to the needle hub 94, it is desirable that the tip portion 20 protrude midway through the needle hub 94 in order to reduce the moment acting on the tip portion 20 including the needle tip 16; however, as in this embodiment, the tip portion 20 may also protrude from the end of the needle hub 94.

[0097] The needle assembly 90 constructed as described above can be deformed from a contracted state to an extended state by pinching the pair of input plate portions 100 with the fingers α and β and pressing them inward in the left-right direction. That is, when force is applied to the input plate portions 100, 100, the first, second, and third bending portions 104, 108, 114 bend and extend, and one end and the other end of the pair of variable plate-shaped portions 98a, 98b move away from each other in the vertical direction, which is the extension direction of the tip portions 20 of the puncture needles 12. As a result, the needle tips 16 of the puncture needles 12 move above the underside of the bottom plate portion 112 that is placed against the patient's skin A to a withdrawal position where puncture is not possible, and the puncture needles 12 that had been inserted into the patient are withdrawn.

[0098] In the needle assembly 90 of this embodiment, the input portion for fingers α and β is a plate-shaped input plate 100, 100. This allows the fingers α and β to make surface contact during input, dispersing the contact pressure acting on the fingers α and β. This reduces pain and discomfort caused by the fingers α and β digging into the needle assembly 90, facilitating pressing operations with the fingers α and β. In this embodiment, the first bent portion 104 is located laterally inward of the second bent portion 108, and the input plate 100 located between the first bent portion 104 and the second bent portion 108 slopes inward laterally as it extends upward. This allows the input plate 100 to be easily grasped from above on the outer lateral surface. By grasping the input plate 100 with the fingers from the side opposite (above) the patient's skin A in the puncture state, it is easy to apply force to the needle assembly 90 in the needle removal direction, facilitating the needle removal procedure.

[0099] 16 to 19 show a needle assembly 120 according to a third embodiment in a contracted state. The needle assembly 120 has a structure in which the puncture needle 12 is attached to a wing member 122.

[0100] The upper end portion of the tip 20, the curved portion 18, and the base 22 of the puncture needle 12 are all fixed to a needle hub 124. The needle hub 124 is integrally equipped with a connecting portion 25 and a tube connection portion 36. The connecting portion 25 of this embodiment does not have a slit 34 as in the first embodiment. The puncture needle 12 is inserted into the needle hub 124 when it is molded, and is fixed integrally to the needle hub 124 in an inseparable, partially embedded state. An insertion portion 126 extending downward is integrally formed with the connection portion 30 of the needle hub 124. The insertion portion 126 is fixed to the upper end portion of the tip 20 of the puncture needle 12, and has a substantially cylindrical outer circumferential surface.

[0101] The wing member 122 comprises a pair of variable plate-shaped portions 40a, 40b and a bottom plate portion 128 that connects the lower ends of the variable plate-shaped portions 40a, 40b. The bottom plate portion 128 has substantially the same outer shape as the bottom plate portion 54 of the first embodiment, and is formed with a needle insertion hole 56 that passes through the center portion in the vertical direction. The needle insertion hole 56 has a larger diameter than the tip portion 20 of the puncture needle 12, and is sized to allow a cap 129 (see FIG. 19) attached to the tip portion 20 to pass through. Note that FIGS. 20 to 22 show the wing member 122 in an unfolded state without being attached to the needle hub 124.

[0102] A protective tube portion 130 is provided around the needle insertion hole 56 in the bottom plate portion 128 as an outer fitting portion that protrudes upward. The protective tube portion 130 is generally cylindrical, with a thick rear portion that protrudes rearward. The inner diameter of the protective tube portion 130 is large enough to allow the insertion portion 126 of the needle hub 124 to be inserted therein. As shown in FIGS. 20 and 22 , multiple inner surface protrusions 132 protrude inward from the inner peripheral surface of the protective tube portion 130. Each inner surface protrusion 132 has a smoothly continuous curved surface, and its upper end portion in particular has a tapered shape that slopes upward toward the outer periphery. The multiple inner surface protrusions 132 are generally identical to one another and are spaced apart approximately evenly around the circumference of the protective tube portion 130. However, multiple types of inner surface protrusions with different shapes and sizes may be provided, or the multiple inner surface protrusions may be unevenly arranged around the circumference.

[0103] The wing member 122 of this embodiment has a plurality of lightening recesses that open to the upper surface in the unfolded state shown in Figures 20 to 22, thereby achieving weight reduction and a reduction in the amount of material used while maintaining strength. However, such lightening recesses are not essential, and the wing member 122 may have a substantially flat surface like the wing member 14 of the first embodiment.

[0104] The upper end of the wing member 122 is attached to the connecting portion 25 of the needle hub 124 by engaging grooves 70, 70 that serve as engaging portions. That is, the engaging groove 70 provided on one variable plate portion 40a is attached to the outer peripheral surface of the first connecting portion 26 of the needle hub 124, and the engaging groove 70 provided on the other variable plate portion 40b is attached to the outer peripheral surface of the second connecting portion 28 of the needle hub 124. As a result, the needle hub 124 is held by the upper portions of the variable plate portions 40a, 40b. The engaging grooves 70, 70 are slidable in the circumferential direction relative to the outer peripheral surface of the needle hub 124, thereby changing the direction (angle) at which the second plate portions 44, 44 of the wing member 122 extend from the needle hub 124 and allowing the wing member 122 to expand and contract.

[0105] A stopper protrusion 134 protrudes from the outer peripheral surface of the fitting groove 70. The stopper protrusion 134 has a tapered shape that narrows in width in the circumferential direction of the fitting groove 70 toward the protruding tip. The stopper protrusion 134 in this embodiment has a shape such that the outer peripheral surface is in contact with the fitting groove 70. In this embodiment, the stopper protrusion 134 is provided on both of the fitting grooves 70, 70, but it is also possible, for example, for the stopper protrusion 134 to be provided on only one of the fitting grooves 70, and the other fitting groove 70 not to have a stopper protrusion 134.

[0106] Furthermore, gripping pieces 136 to be gripped during puncture are provided on the upper sides of the variable plate-shaped portions 40a, 40b, respectively. Similar to the gripping piece 72 of the first embodiment, the gripping piece 136 has a connection base 74 that is narrow in the front-to-rear direction and a gripping tip portion 76 that is wide in the front-to-rear direction, and the connection base 74 protrudes from the vicinity of the connection end portion with the second plate portion 44 of the fitting groove portion 70. The gripping piece 136 does not have a movable portion 78 between the connection base 74 and the gripping tip portion 76, and the gripping tip portion 76 is not allowed to swing (bend) relative to the connection base 74. Furthermore, a movable portion 78 is provided at the connection portion between the connection base 74 of the gripping piece 136 and the second plate portion 44, and the entire gripping piece 136 is allowed to swing (bend) relative to the second plate portion 44.

[0107] When attaching the wing members 122 to the needle hub 124, the cap 129 can be attached to the tip portion 20 of the puncture needle 12 in advance, and the cap 129 can be passed from top to bottom through the needle insertion hole 56. This eliminates the need to attach the cap 129 to the tip portion 20 while the needle hub 124 is attached to the wing members 122, making manufacturing easier. Then, at the time of puncturing, the cap 129 is removed from the puncture needle 12 to expose the needle tip 16 of the tip portion 20. Note that in this embodiment, when the wing members 122 are in the contracted state shown in FIG. 19 , the cap 129 is located below the bottom plate portion 128 and is not inserted into the needle insertion hole 56. However, for example, when the wing members 122 are in the contracted state, the upper end of the cap 129 may be inserted into the needle insertion hole 56, thereby holding the cap 129 at the bottom plate portion 128. The cap 129 can be made of a hard resin or the like, but in this embodiment it is made of a flexible resin tube.

[0108] During puncture, the wing members 122 are in a contracted state as shown in Fig. 23, and the tip 20 of the puncture needle 12 passes through the needle insertion hole 56 in the bottom plate 128 and protrudes below the bottom plate 128. When the needle tip 16 of the puncture needle 12 is positioned at the puncture position, as shown in Fig. 19, the insertion portion 126 of the needle hub 124 is inserted into the protective tube portion 130 of the bottom plate 128, and the insertion portion 126 is fitted into the inner circumference of a plurality of inner surface protrusions 132 protruding from the inner surface of the protective tube portion 130. This forms a position restriction portion 138 that restricts the amount of relative displacement between the needle hub 124 and the bottom plate 128 when the needle tip 16 is positioned at the puncture position. The position restricting portion 138 of this embodiment restricts the relative displacement between the needle hub 124 and the bottom plate portion 128 in the vertical direction and in the direction perpendicular to the vertical direction by fitting the insertion portion 126 into the inner circumference of the protective tube portion 130. The position restricting portion 138 reduces the horizontal displacement (vibration) of the puncture needle 12 relative to the wing members 122, and prevents the puncture needle 12 from unintentionally moving upward relative to the bottom plate portion 128 due to puncture resistance, elasticity of the septum, etc.

[0109] As shown in Figure 23 , the user pinches and holds the gripping pieces 136 with fingers α and β to insert the puncture needle 12 into the patient. As can be seen from Figure 18 , the tip 20 of the puncture needle 12 extends in the up-down direction, which is the puncture direction, at a position where it overlaps the gripping pieces 136, 136 held by the user in the front-to-back direction. In other words, when the gripping pieces 136, 136 are held by the user in the state shown in Figure 23 , the overlapping portions at the upper ends are located on an extension of the tip 20 of the puncture needle 12 toward the upper side. This allows force to be transmitted from the gripping pieces 136 to the tip 20 efficiently and in a balanced manner, making the puncture operation easier. Note that when held by the user in the state shown in Figure 23 , the gripping pieces 136, 136 extend symmetrically from left to right with respect to the extension of the tip 20 of the puncture needle 12 toward the upper side. When the puncture needle 12 is inserted into the patient, the lower surface of the bottom plate portion 128 of the wing member 122 is superimposed on the patient's skin A in a state of contact with the cushioning body 66 therebetween.

[0110] When the puncture needle 12 is to be removed from the patient, the first bent portions 46, 46 of the variable plate-shaped portions 40a, 40b are pushed toward each other in the opposing direction of the variable plate-shaped portions 40a, 40b, thereby deforming the variable plate-shaped portions 40a, 40b into the extended state shown in Figures 24 to 27. This causes the puncture needle 12 to move upward, and the needle tip 16 moves to a withdrawal position above the underside of the bottom plate portion 128. As a result, the puncture needle 12 is removed from the patient, and the needle tip 16 is housed within the protective tube portion 130.

[0111] The variable plate portions 40a, 40b in the extended state are prevented from transitioning to the contracted state by a locking mechanism 84 similar to that in the first embodiment. Furthermore, as shown in Figures 25 and 27, stopper protrusions 134, 134 protruding from the outer peripheral surfaces of the fitting grooves 70, 70, are engaged with the upper ends of the second plate portions 44, 44, thereby preventing the variable plate portions 40a, 40b from transitioning to the contracted state, which would result in a change in the relative angle of the second plate portions 44, 44. The stopper protrusions 134, 134 are configured to be movable over the second plate portions 44, 44 when the variable plate portions 40a, 40b in the contracted state transition to the extended state, and the shape of the outer peripheral surface is set so that the stopper protrusions 134 are engaged without climbing over the second plate portions 44, 44 when the variable plate portions 40a, 40b in the extended state transition to the contracted state.

[0112] In this way, the needle assembly 120 of this embodiment is designed to stably hold the needle tip 16 in the puncture position and the needle withdrawal position, preventing the position of the needle tip 16 from unintentionally moving from the puncture position to the needle withdrawal position or from the needle withdrawal position to the puncture position. This prevents problems such as the puncture needle 12 moving upward due to the elasticity of the septum in the puncture state or the needle tip 16 of the puncture needle 12 being re-exposed below the bottom plate portion 128 after withdrawal.

[0113] Although the embodiments of the present invention have been described in detail above, the present invention is not limited to the specific descriptions. For example, the locking mechanism 84 shown in the above embodiment is merely an example, and any mechanism capable of holding the pair of variable plate-shaped portions 40 a, 40 b in an extended state may be used. For example, only one of the pair of locking portions (48 a, 48 b) may be used, or other structures such as those shown in Figures 28 and 29 may be used.

[0114] 28 is configured such that a locking portion 142 protruding from one variable plate portion 40a has a claw portion 144 at its tip, and when the pair of variable plate portions 40a, 40b are extended and deformed, the puncture needle 12 that climbs over the claw portion 144 is locked by the claw portion 144. When the claw portion 144 is locked by the puncture needle 12, the locking mechanism 140 restricts the separation between one variable plate portion 40a and the puncture needle 12, and maintains the pair of variable plate portions 40a, 40b in an extended state.

[0115] The locking mechanism 150 shown in Figure 29 comprises a needle holding portion 152 that protrudes from one variable plate portion 40a toward the other variable plate portion 40b, and a pushing portion 154 that protrudes from the other variable plate portion 40b toward one variable plate portion 40a. The needle holding portion 152 is a generally rectangular block shape and is formed with a needle accommodating hole 156 that penetrates in the vertical direction (the direction perpendicular to the plane of the paper in Figure 29) and an insertion opening 158 that opens the needle accommodating hole 156 over its entire length toward the protruding tip of the needle holding portion 152. The pushing portion 154 is also generally rectangular block shape, and when the pair of variable plate portions 40a, 40b are in an extended state, the protruding tip approaches or abuts against the protruding tip of the needle holding portion 152. When the pair of variable plate-shaped portions 40a, 40b are extended and deformed, the protruding tip surface of the pushing portion 154 is pressed against the outer peripheral surface of the puncture needle 12, the puncture needle 12 is pushed by the pushing portion 154 into the insertion opening 158 of the needle holding portion 152, and the puncture needle 12 is inserted through the insertion opening 158 into the needle accommodating hole 156. The width of the insertion opening 158 is smaller than the diameter of the needle accommodating hole 156, and the puncture needle 12 inserted into the needle accommodating hole 156 does not come out of the needle accommodating hole 156 through the insertion opening 158. This limits the separation between one variable plate-shaped portion 40a and the puncture needle 12, and the locking mechanism 150 holds the pair of variable plate-shaped portions 40a, 40b in an extended state.

[0116] The puncture needle 12 is not necessarily limited to one that extends in an L-shape with a curved portion 18, but may also be, for example, a straight, hollow needle consisting only of a portion corresponding to the tip portion 20. In this case, for example, by forming the needle hub with a T-shaped cross section and providing a portion that protrudes in the puncture direction (downward) at the middle of the needle hub, and fixing the base end of the puncture needle to this protruding portion, the pair of variable plate-shaped portions 40a, 40b can be attached to the needle hub as in the first embodiment. Note that if the needle hub has an L-shaped cross section and provides a portion that protrudes in the puncture direction (downward) at the tip of the needle hub, and fixing the base end of the puncture needle to this protruding portion, the pair of variable plate-shaped portions 40a, 40b can be attached to the needle hub behind the needle tip 16 as in the second embodiment.

[0117] When the bottom plate portion 54 is provided, the bottom plate portion 54 does not necessarily have to have protruding portions 60, 60 protruding on both the front and rear sides, but may have only one protruding portion 60 protruding on either the front or rear side, or may have a protruding portion protruding in the left and right directions, or may have no protruding portion at all. Also, the protruding portion 60 does not have to have the widening portion 62, and the entire bottom plate portion 54 including the protruding portion 60 may have a substantially constant width.

[0118] The extrapolated portion of the position restricting portion that restricts the relative displacement between the needle hub and the bottom plate portion is not limited to a cylindrical shape like the protective tube portion 130 of the third embodiment. For example, the position restricting portion may be formed by a pair of protrusions that protrude upward from the bottom plate portion 128 toward the needle hub 124, with the insertion portion 126 of the needle hub 124 being inserted between the protrusions. The position restricting portion may also be formed by inserting the insertion portion 126 into the needle insertion hole 56 of the bottom plate portion 128. The insertion portion 126 may be inserted into the protective tube portion 130 as the extrapolated portion with a small gap, thereby restricting only the relative horizontal displacement between the needle hub 124 and the bottom plate portion 128. In this case, the inner surface protrusion 132 that protrudes from the inner peripheral surface of the protective tube portion 130 may be omitted.

[0119] Furthermore, the vertical position regulation of the needle hub and the base plate is not necessarily limited to using the sliding resistance caused by the fitting of the insertion part and the outer fitting part. For example, the vertical position regulation part can be configured by vertically engaging a claw protruding from the outer surface of the insertion part with a claw protruding from the inner surface of the outer fitting part.

[0120] The gripping pieces 72, 136 shown in the above embodiments are merely examples, and the specific form of the gripping pieces should not be interpreted as being limited to the above embodiments. For example, the shape of the gripping pieces is not limited to the plate-like shape of the above embodiments, but can also be other shapes such as a rod-like shape. Furthermore, the number of gripping pieces is not limited to two, but may be, for example, one, or three or more. Furthermore, the gripping pieces may be provided on the needle hub 24, for example, as a pair that can be bent relative to the needle hub 24, or as fixed pieces that protrude outward from the needle hub 24 in a manner that does not bend relative to the needle hub 24.

[0121] REFERENCE SIGNS LIST 10 Needle assembly (first embodiment) 12 Puncture needle 14 Wing member 16 Needle tip 18 Curved portion 20 Tip portion 22 Base portion 24 Needle hub 25 Connecting portion 26 First connecting portion 28 Second connecting portion 30 Connection portion 32 Flange-shaped portion 34 Slit 36 ​​Tube connecting portion 38 Tube 40 (40a, 40b) Variable plate-shaped portion 42 First plate portion 44 Second plate portion 46 First bent portion (input bent portion) 48 (48a, 48b) Locking portion 52 Through hole 54 Bottom plate portion 56 Needle insertion hole 58 Protective tube portion (protective portion) 60 Protruding portion (fixing piece) 62 Widened portion 64 Support portion 66 Cushioning body 68 Second bent portion (lower portion) 70 Fitting groove portion (upper portion, fitting portion) 72 Gripping piece 74 Connection base portion 76 Gripping tip portion 78 Movable portion 80 Medical tape 82 Medical tape 84 Locking mechanism 90 Needle assembly (second embodiment) 92 Wing member 94 Needle hub 96 Connecting portion 98 (98a, 98b) Variable plate portion 100 Input plate portion 102 Hub connecting plate portion 104 First bent portion 106 Bottom connecting plate portion 108 Second bent portion 110 Fitting portion 112 Bottom plate portion 114 Third bent portion 120 Needle assembly (third embodiment) 122 Wing member 124 Needle hub 126 Insertion portion 128 Bottom plate portion 129 Cap 130 Protective tube portion (protective portion, outer insertion portion) 132 Inner surface protrusion 134 Stopper protrusion 136 Grip piece 138 Position restriction portion 140 Lock mechanism (another embodiment) 142 Engagement portion 144 Claw portion 150 Lock mechanism (another embodiment) 152 Needle holding portion 154 Push-in portion 156 Needle accommodating hole 158 Insertion opening A Patient's skin α Index finger β Thumb

Claims

1. a pair of variable plate-shaped parts are arranged opposite each other and are mutually bendable at both upper and lower portions, and a bending portion that can be bent is provided at the middle portion in the height direction of each variable plate-shaped part, and a needle hub of a puncture needle is held in the upper portion of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the vertical direction, which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, A locking mechanism for holding the pair of variable plate-shaped portions in an extended state is provided on the opposing inner surfaces of the pair of variable plate-shaped portions.

2. The needle assembly according to claim 1, wherein the locking mechanism is provided above the bent portion on the variable plate-shaped portion.

3. A needle assembly as described in claim 1 or 2, wherein the lower portions of the pair of variable plate-shaped portions are connected to each other via a bottom plate portion that is placed over the patient's skin.

4. 4. The needle assembly according to claim 3, wherein the bottom plate portion has a protruding portion that protrudes outward beyond the variable plate portion in a longitudinal direction parallel to the bending axis of the variable plate portion.

5. 5. The needle assembly according to claim 4, wherein the protrusion is disposed opposite the needle hub, and the protrusion has a support portion protruding toward the needle hub.

6. The needle hub has a connecting portion extending in a direction intersecting the puncture direction of the puncture needle, The puncture needle protrudes in the puncture direction from the middle of the length of the connecting part, 3. The needle assembly according to claim 1, wherein the upper portions of the pair of variable plate-like portions are attached to one side of the connecting portion so as to sandwich the protruding portion of the puncture needle in the longitudinal direction.

7. the upper portions of the pair of variable plate-shaped portions each include a fitting portion, 7. The needle assembly according to claim 6, wherein the connecting portion is rotatably fitted to the fitting portions of the pair of variable plate-like portions, thereby allowing the pair of variable plate-like portions to bend relative to each other.

8. A gripping piece is provided that is gripped when the puncture needle is inserted, 3. The needle assembly according to claim 1, wherein, at the puncture position, the gripping piece is located between both ends of the variable plate-shaped portion in the longitudinal direction parallel to the bending axis of the variable plate-shaped portion.

9. The gripping piece extends from the variable plate-shaped portion, 9. The needle assembly according to claim 8, further comprising a movable portion that allows the gripping piece to bend relative to the variable plate-like portion.

10. the bent portion of the variable plate-shaped portion is an input bent portion that is pressed when the variable plate-shaped portion is elongated and deformed, 3. The needle assembly according to claim 1, wherein the variable plate-shaped portion is thickened toward the input bending portion.

11. A gripping piece is provided that is gripped when the puncture needle is inserted, 3. The needle assembly according to claim 1, wherein the puncture needle extends in the puncture direction at a position where the puncture needle overlaps with the grip piece in the bending axis direction of the variable plate-shaped portion.

12. A needle assembly as described in Claim 3, wherein the bottom plate portion is provided with a position regulating portion that limits the relative displacement between the needle hub and the bottom plate portion when the needle tip is positioned at the puncture position.

13. a needle insertion hole through which the puncture needle is inserted when the needle tip of the puncture needle is at the puncture position is provided in the bottom plate portion, and an outer insertion portion is provided which protrudes from a periphery of the needle insertion hole toward the needle hub, The needle hub is provided with an insertion portion extending toward the bottom plate portion, 13. The needle assembly according to claim 12, wherein the position regulating portion restricts relative displacement between the needle hub and the bottom plate portion in at least one of the directions of separation between the needle hub and the bottom plate portion and the direction in which the pair of variable plate-shaped portions face each other, and is formed by inserting the insertion portion into the outer insertion portion.

14. The upper portions of the pair of variable plate-shaped portions are provided with groove-shaped fitting portions attached to the outer peripheral surface of the needle hub of the puncture needle, and the fitting portions are capable of sliding relative to the needle hub in the circumferential direction of the needle hub, thereby making the pair of variable plate-shaped portions deformable so as to expand and contract in the up-down direction, which is the puncture direction of the puncture needle, 3. The needle assembly according to claim 1, wherein a stopper projection is provided on the outer surface of the fitting portion of at least one of the variable plate-shaped portions to prevent the tip of the puncture needle from moving from the withdrawal position to the puncture position by engaging with the other variable plate-shaped portion.

15. A pair of variable plate-shaped portions are arranged opposite each other and can be bent relative to each other at both the upper and lower portions, and a bending portion that can be bent and deformed is provided in the middle portion of the height direction of each variable plate-shaped portion, and the needle hub of the puncture needle is held in the upper portion of the pair of variable plate-shaped portions, so that the pair of variable plate-shaped portions can be deformed to expand and contract in the vertical direction, which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, A needle assembly in which the lower portions of the pair of variable plate-shaped portions are connected to each other via a bottom plate portion that is placed on the patient's skin.

16. A pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, the needle hub has a connecting portion extending in a direction intersecting the puncture direction of the puncture needle, The puncture needle protrudes in the puncture direction from the middle of the length of the connecting part, The upper portions of the pair of variable plate-shaped portions are attached to one side of the connecting portion so as to sandwich the protruding portion of the puncture needle in the longitudinal direction.

17. A pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, a gripping piece that is gripped when the puncture needle is inserted is provided, The needle assembly has, at the puncture position, the gripping piece located between both ends of the variable plate-shaped portion in the longitudinal direction parallel to the bending axis of the variable plate-shaped portion.

18. A pair of variable plate-shaped parts are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending part that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped part, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped parts, so that the pair of variable plate-shaped parts can be deformed to expand and contract in the up and down direction which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, a gripping piece that is gripped when the puncture needle is inserted is provided, The needle assembly has the puncture needle extending in the puncture direction at a position where it overlaps with the grip piece in the bending axis direction of the variable plate-shaped portion.

19. A pair of variable plate-shaped portions are arranged opposite each other and can be bent relative to each other at both the upper and lower sides, and a bending portion that can be bent and deformed is provided in the middle part of the height direction of each variable plate-shaped portion, and the needle hub of the puncture needle is held in the upper part of the pair of variable plate-shaped portions, so that the pair of variable plate-shaped portions can be deformed to expand and contract in the up and down direction, which is the puncture direction of the puncture needle, When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, the lower portions of the pair of variable plate-shaped portions are connected to each other via a bottom plate portion that is placed on the patient's skin, The needle assembly has a position restricting portion on the bottom plate portion that restricts relative displacement between the needle hub and the bottom plate portion when the needle tip is positioned at the puncture position.

20. A pair of variable plate-like portions are arranged opposite each other and are mutually bendable at both upper and lower side portions, and a bending portion capable of bending and deforming is provided at the intermediate portion in the height direction of each variable plate-like portion, a pair of variable plate-shaped portions having groove-shaped fitting portions attached to the outer peripheral surface of the needle hub of the puncture needle, the fitting portions being slidable relative to the needle hub in the circumferential direction of the needle hub, so that the pair of variable plate-shaped portions are deformable to expand and contract in the up-down direction, which is the puncture direction of the puncture needle; When the pair of variable plate-shaped parts are in a contracted state, the position of the needle tip of the puncture needle is a puncture position where puncture is possible, and when the pair of variable plate-shaped parts are in an extended state, the position of the needle tip is a needle withdrawal position where the needle is withdrawn, A needle assembly in which a stopper protrusion is provided on the outer surface of the fitting portion of at least one of the variable plate-shaped portions to prevent the needle tip from moving from the needle withdrawal position to the puncture position by engaging with the other variable plate-shaped portion.

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