Needle assembly

Abstract

To provide a needle assembly less likely to cause a puncture accident.SOLUTION: A needle assembly comprises: a puncture needle 201; and a needle protection part 101 including first and second variable plate-like parts 111 and 112 with bendable and deformable intermediate parts, a needle hub 114, and a bottom plate part 115. The needle protection part 101 can displace between an initial position where the first and second variable plate-like parts 111 and 112 are bent to make the needle hub 114 and the bottom plate part 115 approach each other and thereby to protrude a needle tip 211 from the bottom plate 115, to a protection completion position where the first and second variable plate-like parts 111 and 112 extend to store the needle tip 211 between the first and second deformable plate-like parts 111 and 112 and thereby to complete the protection of the puncture needle 201. The needle protection part 101 includes a resistance generation portion for generating resistance to restrict the displacement to the initial position side until it is displaced from the initial position to the protection completion position, and a lock portion for maintaining the protection completion position.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present disclosure relates to a needle assembly, and more particularly to a needle assembly having a needle guard surrounding a puncture needle. [Background technology]

[0002] In order to administer drugs to a patient's blood vessels over a long period of time, an access port may be implanted under the patient's skin. The access port is equipped with a septum made of silicone rubber or the like, and a needle is inserted into the septum from above the patient's skin to administer drugs or take blood samples. After administration of drugs or the like is completed, the needle is removed and the septum is sealed.

[0003] In order to improve the operability and safety of the needle to be inserted into the access port, a needle assembly has been considered that has a needle protection part in which two plates that can be bent and deformed in a pantograph shape are arranged facing each other and surround the needle (see, for example, Patent Document 1). The needle is inserted in an initial position where the two plates are bent, and the needle can be removed by extending the two plates. When the removed needle is housed between the two extended plates at the protection completion position, a locking tab is activated to lock the needle in the protection completion position, improving safety. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special table number 2002-529156 Summary of the Invention [Problem to be solved by the invention]

[0005] However, the conventional needle assembly has the following problems. When the needle is removed from the skin by extending the two plates, the pressure on the needle is removed and the operational resistance drops rapidly. When the needle is removed from the skin and the operational resistance is very small, the operator feels a very large operational resistance when activating the locking tab, and there is a risk that the operator will mistakenly believe that the protection completion position has been reached before the locking tab is activated and stop the operation. If the operator stops the operation before the locking tab is activated due to such a mistake, deformation toward the initial position can easily occur, and the needle once housed in the needle protection section will protrude again, which may cause a needlestick injury.

[0006] An object of the present disclosure is to solve problems that may arise in conventional needle assemblies and to realize a needle assembly that is less likely to cause needlestick injuries. [Means for solving the problem]

[0007] A first aspect of the needle assembly of the present disclosure comprises a puncture needle, first and second variable plate-shaped members arranged opposite each other across the puncture needle and capable of being bent and deformed at their middle portions, a needle hub connected to the upper portions of the first and second variable plate-shaped members and holding the puncture needle, and a bottom plate portion connected to the lower ends of the first and second variable plate-shaped members, the needle protection member being displaceable between an initial position in which the first and second variable plate-shaped members are bent to bring the needle hub and the bottom plate portion closer together and the tip of the puncture needle protrudes beyond the bottom plate portion, to a protection completion position in which the first and second variable plate-shaped members extend and the tip of the puncture needle is contained between the first and second variable plate-shaped members, completing protection of the puncture needle, and the needle protection member has a resistance generating portion that generates resistance to limit displacement toward the initial position during displacement from the initial position to the protection completion position, and a locking portion for maintaining the protection completion position.

[0008] According to the first aspect of the needle assembly, the resistance generating section limits the displacement of the needle protector toward the initial position during the period from the initial position to the protection completion position. Therefore, even if the operator stops the operation before the needle protector is completely displaced to the protection completion position, the needle protector will not easily displace toward the initial position, making it difficult for the needle tip to protrude again.

[0009] In the first aspect of the needle assembly, the resistance generating portion can function as a return stopper that prevents the needle assembly from being displaced toward the initial position. By adopting such a configuration, even if the needle assembly is not completely displaced to the protection completion position, the needle assembly can be prevented from being displaced toward the initial position, making it more difficult for the needle tip to protrude again.

[0010] In the first aspect of the needle assembly, the resistance generating section can provide the operator with a continuous clicking sensation. Since the operator is likely to continue the operation by applying the same force while the clicking sensation continues, erroneous operation such as stopping the operation at a position other than the protection completion position is unlikely to occur. This can prevent the needle from re-projecting. In addition, the clicking sensation can encourage the operator to apply an appropriate amount of force, so that excessive force can be prevented from damaging the needle protection section or causing the needle tip to shake significantly, making it impossible to safely deform the needle.

[0011] In a first aspect of the needle assembly, the first and second variable plate-shaped parts are each connected to the needle hub by a rotatable pivot connection part, and the resistance generating part has a member provided on at least one of the first and second variable plate-shaped parts and the needle hub that slides against each other, and can generate resistance to the pivoting of the pivot connection part. By adopting such a configuration, the magnitude of the operational resistance required for the deformation of the needle protection part can be easily controlled.

[0012] In a first aspect of the needle assembly, the pivot connection part has a fitting part with a C-shaped cross section formed on the first and second variable plate parts, a connecting part formed on the needle hub with which the fitting part fits, and a flange part having a larger diameter than the connecting part, at least one of the first and second variable plate parts has an abutment end surface that abuts and slides against the flange part, and the resistance generating part can generate resistance to the sliding between the abutment end surface and the flange part. With this configuration, the magnitude of the resistance to be generated and the range in which the resistance is generated can be easily set.

[0013] In the first aspect of the needle assembly, the resistance generating portion may be a projection or recess formed on the contact end surface and the flange portion, which are capable of climbing over each other. By adopting such a configuration, the magnitude of the generated resistance can be easily adjusted.

[0014] In the first aspect of the needle assembly, the projections and recesses can be made to be capable of being overcome to displace the needle assembly to the protection completion position, but prevented from being overcome to displace the needle assembly to the initial position. This configuration makes it extremely difficult for the needle assembly to be deformed back to the initial position, making it more difficult for erroneous operation to occur. The needle assembly can also be maintained in the protection completion position, improving safety.

[0015] In a first aspect of the needle assembly, the resistance generating section may have sliding members provided on both sides of the intermediate section of at least one of the first and second variable plate-shaped sections, sliding members provided on at least one of the first and second variable plate-shaped sections and the bottom plate section, or sliding members provided at opposing positions of the first and second variable plate-shaped sections, so as to generate resistance to deformation of at least one of the first and second variable plate-shaped sections. With this configuration, the magnitude of the operational resistance required for deformation of the needle protection section can be easily controlled, as in the case of generating resistance to deformation between the needle hub and the variable plate-shaped section.

[0016] In the first aspect of the needle assembly, the bottom plate may have a displacement limiting portion that releasably engages with the needle hub in the initial position to limit the displacement of the needle protection portion. This configuration makes it possible to prevent erroneous operation that would deform the needle protection portion during puncture.

[0017] A second aspect of the needle assembly comprises a puncture needle, first and second variable plate-shaped members arranged opposite each other across the puncture needle and capable of being bent and deformed at their middle portions, a needle hub connected to the upper portions of the first and second variable plate-shaped members and holding the puncture needle, and a needle protection member having a bottom plate portion connected to the lower ends of the first and second variable plate-shaped members, the needle protection member being displaceable between an initial position in which the first and second variable plate-shaped members are bent so that the needle hub and the bottom plate portion approach each other and the tip of the puncture needle protrudes beyond the bottom plate portion, to a protection completion position in which the first and second variable plate-shaped members extend and the tip of the puncture needle is contained between the first and second variable plate-shaped members, completing protection of the puncture needle, the needle protection member having a resistance generating portion which applies operational resistance to the displacement, and a locking portion for maintaining the protection completion position, the resistance generating portion giving the operator a continuous clicking sensation until the locking portion is activated.

[0018] The second embodiment of the needle assembly has a resistance generating section that gives the operator a continuous clicking sensation until the locking section is activated. The clicking sensation encourages the operator to continue the same operation, making it difficult for the operation to be stopped midway through the transformation, and the operation can be continued until the locking section is activated. This makes it difficult for the operator to mistakenly think that the locking section has been activated when it has not been activated and to stop the operation, thereby preventing the needle from re-projecting. In addition, the clicking sensation can encourage the operator to apply an appropriate amount of force, so that it is possible to avoid damage to the needle protection section or a large deviation in the needle tip that makes it impossible to perform a safe transformation due to excessive force. Effect of the Invention

[0019] According to the needle assembly of the present disclosure, operational errors can be made less likely to occur. [Brief description of the drawings]

[0020] [Figure 1] FIG. 1 is a perspective view of one embodiment of a needle assembly. [Diagram 2] FIG. 1 is a cross-sectional view of one embodiment of a needle assembly. [Diagram 3] FIG. 1 is a front view of one embodiment of a needle assembly in an initial position. [Figure 4] FIG. 1 is a front view of an embodiment of a needle assembly in a withdrawn position. [Diagram 5] FIG. 13 is a front view of one embodiment of a needle assembly in a fully protected position. [Figure 6] FIG. 2 is a perspective view showing a resistance generating portion of a needle assembly according to one embodiment. [Figure 7] FIG. 4 is a front view showing the resistance generating portion in an initial position. [Figure 8] FIG. 13 is a front view showing the resistance generating portion in the needle withdrawal position. [Figure 9] FIG. 4 is a front view showing the resistance generating portion in the protection completed position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] As shown in Figures 1 and 2, the needle assembly in one embodiment has a puncture needle 201 and a needle protection part 101. In this embodiment, the puncture needle 201 is a Huber needle that is inserted into the septum of a subcutaneously implantable port. The puncture needle 201 has a tip part 210 formed with a sharp needle tip 211, and a base part 220 that is bent so as to be substantially perpendicular to the tip part 210. The orientation of the needle assembly in this embodiment when used is not limited, but in the following description, the tip part 210 extends in the vertical direction with the needle tip 211 facing downward, and the base part 220 extends in the front-rear direction with the base end at the rear.

[0022] The needle protection part 101 has a first variable plate-shaped part 111 and a second variable plate-shaped part 112 arranged opposite each other on the left and right sides of the puncture needle 201, a needle hub 114 connected to the upper ends of the first variable plate-shaped part 111 and the second variable plate-shaped part 112 and holding the puncture needle 201, and a bottom plate part 115 connected to the lower ends of the first variable plate-shaped part 111 and the second variable plate-shaped part 112.

[0023] The first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 each have an upper plate portion 121 and a lower plate portion 122 that are connected to each other so as to be able to bend. Therefore, the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 can be bent and deformed at an intermediate portion where the upper plate portion 121 and the lower plate portion 122 are connected, and the needle protection portion 101 including the needle hub 114 and the bottom plate portion 115 can be deformed in a pantograph-like manner with the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 being mirror-symmetrical.

[0024] The bottom plate portion 115 is a plate-like member whose length in the front-rear direction is approximately equal to the lower end of the lower plate portion 122 and whose width in the left-right direction is narrow. The lower ends of the lower plate portions 122 of the first variable plate portion 111 and the second variable plate portion 112 are bendably connected to both sides of the bottom plate portion 115. A through hole 128 through which the tip portion 210 of the puncture needle 201 is inserted is formed in the center of the bottom plate portion 115, and a protective tube portion 127 is formed surrounding the through hole 128 and protruding upward.

[0025] A fitting portion constituting a C-groove is formed at the upper end of the upper plate portion 121. The length of the fitting portion in the front-rear direction is equal to or less than half the length of the upper plate portion 121 in the front-rear direction. A first fitting portion 131 is formed in the first variable plate portion 111, and a second fitting portion 132 is formed in the second variable plate portion 112, but the first variable plate portion 111 and the second variable plate portion 112 have the same shape. Therefore, when the first variable plate portion 111 and the second variable plate portion are arranged to face each other with the needle hub 114 in between, the first fitting portion 131 and the second fitting portion 132 are misaligned from each other in the front-rear direction, and therefore can be connected to the needle hub 114 without interfering with each other.

[0026] In this embodiment, the needle hub 114 has a horizontal cylinder portion 141 extending in the front-rear direction, and a vertical cylinder portion 142 protruding downward from the horizontal cylinder portion 141. The tip 210 of the puncture needle 201 extends and protrudes downward from the vertical cylinder portion 142. A tube connection portion 144 for connecting a tube 251 is formed at the rear end of the horizontal cylinder portion 141. A coupling portion into which the C-groove of the fitting portion fits is formed further forward than the tube connection portion 144 of the horizontal cylinder portion 141.

[0027] In this embodiment, a first connecting portion 151 into which the first fitting portion 131 fits is formed on the front side, and a second connecting portion into which the second fitting portion 132 fits is formed on the rear side. Flanges 155 and 156 having a larger diameter than the connecting portions are formed on the front and rear sides of the two connecting portions, respectively. Therefore, when the fitting portion is fitted into the connecting portion, the upper plate portion 121 can rotate about the needle hub 114 as an axis, but movement in the front-rear direction is restricted.

[0028] The first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 are disposed opposite each other, and the vicinity of the upper end of the upper plate portion 121 is connected to the needle hub 114 so as to be rotatable about the axis, the lower end of the lower plate portion 122 is connected to the bottom plate portion 115 so as to be bendable, and the upper plate portion 121 and the lower plate portion 122 are connected to each other so as to be bendable. Therefore, when the upper plate portion 121 is rotated relative to the needle hub 114, the connection portion between the upper plate portion 121 and the lower plate portion 122 and the connection portion between the lower plate portion 122 and the bottom plate portion 115 are also bent. The first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 deform in a mirror symmetric manner to each other. Therefore, by rotating the first fitting portion 131 relative to the first connecting portion 151 and rotating the second fitting portion 132 relative to the second connecting portion 152, the needle protection portion 101 is bent or extended, and when bent, the needle hub 114 and the bottom plate portion 115 move closer to each other, and when extended, the needle hub 114 and the bottom plate portion 115 move away from each other.

[0029] In this embodiment, upper plate portion 121 and needle hub 114 are connected by a pivotal connection portion that is configured with a fitting portion having a C-shaped groove and a connecting portion that is an axis into which the C-shaped groove fits. However, various configurations that allow upper plate portion 121 to rotate around needle hub 114 as an axis can be adopted as the pivotal connection portion. Furthermore, upper plate portion 121 and needle hub 114 can also be connected by a thin-walled connecting portion or the like that allows bending.

[0030] In this embodiment, the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 have a wing portion 135 on the opposite side to the upper plate portion 121 across the fitting portion. The wing portion 135 is connected to the upper plate portion 121 by a thin hinge that moves relatively freely. Therefore, the positional relationship of the wing portion 135 with the upper plate portion 121 can be freely changed. As shown in FIG. 1, in the needle assembly before use, the wing portion 135 is folded so as to abut against the upper plate portion 121. When puncturing, as shown in FIG. 3, the wing portion 135 can be raised so as to move away from the upper plate portion 121. By gripping the raised wing portion 135, puncturing can be easily performed. After puncturing, the wing portion 135 can be folded so as to abut against the upper plate portion 121. In this way, the needle assembly does not get in the way of the patient during use, and can be easily attached to the patient's skin with tape or the like.

[0031] The needle assembly of this embodiment is configured so that the needle tip 211 of the puncture needle 201 is located in the center of the wing portion 135 in the front-rear direction. In this way, the operator can intuitively grasp the position of the needle tip 211, making it easy to perform puncture. However, the positional relationship between the wing portion 135 and the needle tip 211 can also be different. Furthermore, the wing portion 135 may be provided as necessary, and a configuration in which it is not provided can also be used.

[0032] The length of the tip 210 of the puncture needle is longer than the distance between the needle hub 114 and the bottom plate 115 when the first variable plate portion 111 and the second variable plate portion 112 are bent to the maximum, and shorter than the distance between the needle hub 114 and the bottom plate 115 when the connection portion between the upper plate portion 121 and the lower plate portion 122 is extended to the maximum. Therefore, as shown in FIG. 3, the maximum bent state is an initial position in which the needle tip 211 of the puncture needle 201 protrudes downward from the bottom plate portion 115 and can puncture. Note that FIG. 3 shows a state in which the wing portion 135 is separated from the upper plate portion 121 and stands up, but in the initial position the wing portion 135 may be in contact with the upper plate portion 121 or may be in another position.

[0033] When the first variable plate-shaped part 111 and the second variable plate-shaped part 112 are extended from the initial position by pressing the connection part between the upper plate part 121 and the lower plate part 122 of the first variable plate-shaped part 111 and the second variable plate-shaped part 112 from both sides, the distance between the needle hub 114 and the bottom plate part 115 gradually increases, and the needle tip 211 does not protrude from the bottom plate part 115 and the needle is removed from the skin, as shown in Fig. 4. Furthermore, when the first variable plate-shaped part 111 and the second variable plate-shaped part 112 are extended to the maximum extension state, the needle tip 211 of the puncture needle 201 is accommodated in the space surrounded by the first variable plate-shaped part 111 and the second variable plate-shaped part 112, which are the needle protection part 101, and the bottom plate part 115, as shown in Fig. 5, and reaches the protection completion position.

[0034] In this embodiment, the upper plate 121 of the first variable plate part 111 and the second variable plate part 112 is formed with a guide protrusion 125 standing from the upper plate part 121. The guide protrusion 125 is formed to a size that fits between the opposing lower plate part 122 in the initial position and fits between the opposing upper plate part 121 of the other variable plate part in the protection completion position. In addition, the guide protrusion 125 of the first variable plate part 111 is located on the rear side, and the guide protrusion 125 of the second variable plate part 112 is located on the front side so that the puncture needle 201 is sandwiched between the two guide protrusions 125 in the protection completion position. Therefore, the puncture needle 201 accommodated between the two variable plate parts in the protection completion position can be prevented from shaking in the front-rear direction and jumping out of the accommodation space. However, the guide protrusion 125 can be formed as necessary, and may not be formed.

[0035] In this embodiment, the lower plate 122 of the first variable plate-shaped part 111 and the second variable plate-shaped part 112 is formed with a blind plate 126 standing up from the lower plate 122. The blind plate 126 of the first variable plate-shaped part 111 is located on the front side, and the blind plate of the second variable plate-shaped part 112 is located on the rear side so that the two blind plates 126 face each other with the puncture needle 201 in between. Therefore, at the protection completion position, the needle tip 211 of the puncture needle 201 is surrounded on four sides by the lower plate parts 122 and the blind plates 126 of the first variable plate-shaped part 111 and the second variable plate-shaped part 112. This allows for safer protection.

[0036] In this embodiment, the length of the blind plate 126 is slightly shorter than the length of the lower plate portion 122, and the height is formed so that the blind plate 126 fits between the opposing upper plate portion 121 in the initial position and fits between the opposing lower plate portion 122 of the other variable plate portion in the protection completion position. In addition, in this embodiment, the interval between the upper plate portion 121 and the lower plate portion 122 in the initial position is narrow on the outer side where the connection portion between the upper plate portion 121 and the lower plate portion 122 is located, and is wide on the center side where the puncture needle 201 is located. In addition, the interval between the two lower plate portions 122 in the protection completion position is narrower on the upper side than on the lower side. In accordance with this, the blind plate 126 protrudes from the lower plate portion 122 on the upper plate portion 121 side than on the bottom plate portion 115 side. Therefore, the blind plate 126 does not get in the way in the initial position and the protection completion position, and the exposure of the puncture needle 201 in the protection completion position can be minimized. The configuration of the blindfold 126 is not limited to the above, and various configurations can be adopted that can surround the needle tip 211 at the protection complete position. Also, the blindfold 126 can be formed as necessary, or it can be configured not to be formed.

[0037] In this embodiment, the inner diameter of the C-groove portion of the first fitting portion 131 and the second fitting portion 132 is approximately equal to the outer diameter of the first connecting portion 151 and the second connecting portion 152, and the outer diameter of the C-groove portion including the thickness of the plate forming the C-groove is approximately equal to the outer diameter of the flange portion 155 provided at the end portion of the first connecting portion 151 and the second connecting portion 152. In addition, the length in the front-rear direction of the C-groove portion of the first fitting portion 131 and the second fitting portion 132 is approximately equal to the length in the front-rear direction of the first connecting portion 151 and the second connecting portion 152. Therefore, when the first fitting portion 131 is fitted into the first connecting portion 151 and rotated, the end face of the first fitting portion 131 slides against the inner surfaces of the flange portions 155, 156 of the first connecting portion.

[0038] 6 to 9, in this embodiment, a plurality of end surface protrusions 181 are formed on the end surface on the front side of the first fitting portion 131. Also, an inner surface protrusion 182 is formed on the inner surface of the flange portion 155 on the front side of the first connecting portion 151. The end surface protrusions 181 and the inner surface protrusions 182 function as a resistance generating portion that generates resistance to rotation when the first fitting portion 131 is rotated relative to the first connecting portion 151. This makes it possible to prevent a large deformation that may induce erroneous operation from occurring between the initial position and the protection completion position even when only a light force is applied.

[0039] In this embodiment, the end surface protrusion 181 is a protrusion having a triangular cross section having an inclined surface and a substantially vertical surface. Therefore, the inclined surface of the end surface protrusion 181 comes into contact with the inner surface protrusion 182 from the initial position side to the protection completion position side, so that the first fitting part 131 can rotate by sliding over it. On the other hand, the substantially vertical surface of the end surface protrusion 181 comes into contact with the inner surface protrusion 182 from the protection completion position side to the initial position side, so that it is difficult to get over it, and the rotation of the first fitting part 131 is restricted, so that the resistance generating part also functions as a return stopper. In addition, the last end surface protrusion 181 also functions as a locking part for maintaining the protection completion position. By bending the needle protection part 101 and restricting the rotation in the direction returning to the initial position side, it is possible to further reduce the likelihood of an erroneous operation in which the needle tip 211 once housed in the internal space of the needle protection part 101 is exposed again.

[0040] Even if the end surface protrusion 181 has a shape that allows it to get over the inner surface protrusion 182 in either direction, it is effective because it generates resistance and makes it difficult for the needle to move from the protection completion position side toward the initial position side, so that the needle does not easily re-protrude. Even in this case, it is preferable that the end surface protrusion 181 that gets over the inner surface protrusion 182 just before reaching the protection completion position has a shape that does not allow it to get over in the opposite direction so that the protection completion position can be maintained. Also, by making the shape of the inner surface protrusion 182 asymmetrical, it is possible to make it so that the end surface protrusion 181 cannot or has difficulty getting over the inner surface protrusion 182 in the direction from the protection completion position side toward the initial position side.

[0041] In this embodiment, since the end surface protrusions 181 are formed in a plurality of successive positions, the resistance generating section can provide the operator with a continuous clicking sensation. While the clicking sensation continues, the operator is likely to continue the operation by applying a force equivalent to that required when the first end surface protrusion 181 overcomes the inner surface protrusion 182, which makes it difficult to induce an erroneous operation in which the operation is stopped before the protection completion position is reached. In this case, it is preferable to make the force required for each end surface protrusion 181 to overcome the inner surface protrusion 182 approximately constant. It is preferable that the last end surface protrusion 181 that overcomes the inner surface protrusion 182 just before the protection completion position is not able to overcome it to the initial position side, and serves as a locking section that maintains the protection completion position. The locking section that maintains the protection completion position may be formed of a member other than the resistance generating section.

[0042] The circumferential length and height of the multiple end face protrusions 181 can be uniform, but these can also be changed to change the magnitude of resistance generated depending on the position. For example, the circumferential length of the end face protrusion 181 that overcomes the inner face protrusion 182 on the initial position side can be made longer, and the circumferential length of the end face protrusion 181 that overcomes on the protection completion position side can be made shorter.

[0043] Resistance is generated due to the puncture needle 201 being pressed by the septum and the skin during the period from the initial position in FIG. 3 to the needle withdrawal position in FIG. 4. Therefore, it is possible to prevent the resistance from being too large during this period by preventing the resistance from being generated by the resistance generating unit against the deformation of the needle protection unit 101. In this embodiment, by adjusting the range in which the end surface convex portion 181 is formed, it is possible to easily set from where the resistance is generated by the resistance generating unit against the deformation of the needle protection unit 101. For example, it is possible to generate resistance from the needle withdrawal position where the needle tip 211 is withdrawn from the skin shown in FIG. 4, or to generate resistance from the position where the needle tip 211 protrudes from the bottom plate portion 115 by about 0.5 mm to 2 mm so that resistance is generated from the time when the needle tip 211 is withdrawn from the septum.

[0044] The resistance generating portion is not limited to a combination of the end face convex portion 181 and the inner face convex portion 182, and various configurations can be adopted. For example, a configuration in which one of the end face convex portion 181 and the inner face convex portion 182 is made a concave portion and fits into each other to generate resistance. Although the resistance generating portion is shown to have a configuration that gives the operator a clicking sensation, the resistance generating portion is not limited to one that gives a clicking sensation. Even if a clicking sensation is not given, it is useful because it is difficult to deform the needle protection portion 101 toward the initial position by increasing the operation resistance and increasing the force required to deform the needle protection portion 101. In addition, it is possible to reduce erroneous operation such as applying too large a force. For example, a portion with rough surface roughness can be formed in a predetermined circumferential range of the first fitting portion 131 so that a large sliding resistance is generated when the portion comes into contact with the inner face convex portion 182.

[0045] The resistance generating portion can be formed between the end face on the rear end side of the first fitting portion 131 and the rear end side flange portion 156. Also, resistance can be generated between the inner surface of the C-groove of the first fitting portion 131 and the outer surface of the first connecting portion 151.

[0046] In the initial position shown in Fig. 3, the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112 are deformed in a substantially mirror-symmetric manner by pressing inward from both sides the connection portion between the upper plate portion 121 and the lower plate portion 122 bent in a L-shape of the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112. Therefore, by generating resistance to the deformation on the first variable plate-shaped portion 111 side, it is possible to control the deformation of the entire needle protection portion 101. However, various resistance generating portions can also be formed on the second variable plate-shaped portion 112 side. Also, they can be formed on both the first variable plate-shaped portion 111 and the second variable plate-shaped portion 112.

[0047] The resistance generating portion may be configured to generate resistance by limiting deformation between the lower plate portion 122 and the bottom plate portion 115. For example, when the first variable plate portion 111 and the second variable plate portion 112 are extended, a cover plate 126 standing from the lower plate portion 122 and a protective tube portion 127 standing from the bottom plate portion 115 come into contact with each other, so that resistance is generated between the cover plate 126 and the protective tube portion 127. Not limited to the cover plate 126 and the protective tube portion 127, various configurations that generate resistance by sliding can be adopted.

[0048] Also, a configuration in which deformation between the upper plate portion 121 and the lower plate portion 122 is restricted to generate resistance can be used. For example, at least one of the upper plate portion 121 and the lower plate portion 122 of the first variable plate portion 111 and the second variable plate portion 112 can be provided with members that slide against each other to generate resistance. Also, at opposing positions on the first variable plate portion 111 side and the second variable plate portion 112 side, members that slide against each other to generate resistance can be provided. In this case, a resistance generating portion can be provided between the upper plate portions 121, or a resistance generating portion can be provided between the lower plate portions 122. A plurality of these resistance generating portions can also be combined.

[0049] In this embodiment, the vertical cylinder portion 142 of the needle hub 114 is releasably fitted into the protective cylinder portion 127 at the initial position so that deformation from the initial position to the protection complete position does not start unless a force is intentionally applied. This configuration makes it difficult for the needle protection part 101 to be unintentionally deformed from the initial position. The displacement limiting part that limits unintentional deformation of the needle protection part 101 at the initial position is not limited to this configuration and various configurations can be adopted.

[0050] Protective tube part 127 may be configured to generate frictional resistance between itself and puncture needle 201. This configuration also makes it possible to prevent unintended deformation of needle protective part 101 that may lead to erroneous operation.

[0051] The height of the protective tube portion 127 can be adjusted so that the needle tip 211 of the puncture needle 201 does not completely come out of the protective tube portion 127 at the protection completion position. This configuration can further improve safety. However, the height of the protective tube portion 127 can also be configured so that the needle tip 211 of the puncture needle is above the upper end of the protective tube portion 127 at the protection completion position. Also, the protective tube portion 127 may be formed as necessary, and may not be formed at all.

[0052] In this embodiment, a support base 129 that protrudes upward is formed rearward of the protective tube portion 127 of the bottom plate portion 115. The support base 129 is formed to abut against and support the tube connection portion 144 in the initial position. This makes it possible to prevent a large force being applied to the tube connection portion protruding rearward when the needle assembly in the initial position is inserted, which can cause the tube connection portion to bend or break. The support base 129 may be formed as necessary, and may also be omitted in an alternative configuration.

[0053] In this embodiment, the end surface convex portion 181 can only get over the inner surface convex portion 182 in one direction, and the resistance generating portion has a function as a return stopper that prevents the needle protection portion 101 from deforming from the protection completion position side to the initial position side. However, the function of the return stopper can be performed by another configuration. The return stopper can be a portion that prevents deformation toward the initial position side at a position before the protection completion position, but can also be a locking portion that operates at the protection completion position. For example, the two guide convex portions 125 can be engaged with each other when the protection completion position is reached, or a claw portion or the like that engages with the guide convex portion 125 when the protection completion position is reached can be formed on the upper plate portion 121 on the opposite side, thereby preventing deformation in the opposite direction. A portion other than the guide convex portion 125 can also be the return stopper. A plurality of these return stoppers can also be combined.

[0054] In this embodiment, in order to facilitate bending and extending operations, the connection portion between the upper plate portion 121 and the lower plate portion 122 and the connection portion between the lower plate portion 122 and the bottom plate portion 115 are formed thinner than other portions of the variable plate-shaped portion. Also, the connection portion has a shorter length in the front-rear direction than the two plate portions it connects, so that bending and extending can occur more easily. The connection portions of the plate portions can also be configured to rotate relative to each other.

[0055] In this embodiment, the bottom plate 115 is configured with a soft sheet 115b attached to the lower surface of the hard bottom plate main body 115a. By making the lower surface of the bottom plate 115 that touches the patient's skin soft, the soft sheet 115b easily adheres to the patient's skin when the needle assembly is punctured, so that the needle assembly can be used stably. In addition, it is possible to reduce discomfort for the patient. For example, the sheet 115b can be made of a resin elastomer or rubber. A soft sheet can also be attached to a portion other than the bottom plate 115, such as the outside of the lower plate 122, that may touch the patient's skin. The attachment of the soft sheet may be performed as necessary, and the configuration may be such that the soft sheet is not attached. [Industrial Applicability]

[0056] The needle assembly of the present disclosure is less prone to operational errors and is particularly useful in medical applications. [Explanation of symbols]

[0057] 101 Needle protection part 111 First variable plate-shaped portion 112 Second variable plate-shaped portion 114 Needle Hub 115 Bottom plate part 115a Bottom plate main body 115b sheet 121 Board part 122 Board part 125 Guide protrusion 126 Blind Board 127 Protective barrel 128 Through hole 129 Support stand 131 First fitting part 132 Second fitting part 135 Gripping part 141 Horizontal tube part 142 Vertical cylinder part 144 Tube connection 151 1st connection part 152 2nd connection part 155 Flange 156 Flange 181 End face convex part 182 Inner convex part 201 Puncture needle 210 Tip 211 Needle tip 220 base 251 Tube

Claims

1. A puncture needle, a needle protection part including first and second variable plate-shaped parts disposed opposite each other with the puncture needle therebetween and capable of being bent and deformed at their middle parts, a needle hub connected to upper parts of the first and second variable plate-shaped parts and holding the puncture needle, and a bottom plate part connected to lower ends of the first and second variable plate-shaped parts, the needle protection portion is displaceable between an initial position in which the first and second variable plate-shaped portions are bent, the needle hub and the bottom plate portion are brought close to each other, and the tip of the puncture needle protrudes beyond the bottom plate portion, and a protection completion position in which the first and second variable plate-shaped portions are extended, the tip of the puncture needle is contained between the first and second variable plate-shaped portions, and protection of the puncture needle is completed; The needle protection portion has a resistance generating portion that generates resistance to limit displacement toward the initial position while the needle protection portion is displaced from the initial position to the protection completion position, and a locking portion that maintains the protection completion position.

2. The needle assembly according to claim 1 , wherein the resistance generating portion functions as a return stop portion that prevents displacement toward the initial position.

3. The needle assembly according to claim 1 , wherein the resistance generating portion provides a continuous clicking sensation to an operator.

4. The first and second variable plate-shaped portions are each connected to the needle hub by a pivot connection portion that is pivotable; The needle assembly according to claim 1 , wherein the resistance generating portion has a sliding member provided on at least one of the first and second variable plate-shaped portions and the needle hub, and generates resistance to rotation of the rotating connection portion.

5. the pivot connection portion includes a fitting portion having a C-shaped cross section formed on the first and second variable plate-shaped portions, a connecting portion formed on the needle hub, into which the fitting portion fits, and a flange portion having a larger diameter than the connecting portion; At least one of the first and second variable plate-shaped portions has an abutment end surface that abuts and slides against the flange portion, The needle assembly according to claim 4 , wherein the resistance generating portion generates resistance to sliding between the abutment end surface and the flange portion.

6. 6. The needle assembly according to claim 5, wherein the resistance generating portion is a projection and recess formed on the contact end surface and the flange portion so that they can overcome each other.

7. The needle assembly according to claim 6 , wherein the unevenness is capable of being overcome to displace the needle assembly toward the protection completion position, and is prevented from being overcome to displace the needle assembly toward the initial position.

8. 2. The needle assembly according to claim 1, wherein the resistance generating portion has sliding members provided on both sides of the intermediate portion in at least one of the first and second variable plate-shaped portions, sliding members provided on at least one of the first and second variable plate-shaped portions and the bottom plate portion, or sliding members provided at opposing positions on the first and second variable plate-shaped portions, and generates resistance to deformation of the needle protection portion.

9. The needle assembly according to claim 1 , wherein the base plate portion has a displacement limiting portion that releasably engages with the needle hub in the initial position to limit displacement of the needle guard portion.

10. A puncture needle, a needle protection part including first and second variable plate-shaped parts disposed opposite each other with the puncture needle therebetween and capable of being bent and deformed at their middle parts, a needle hub connected to upper parts of the first and second variable plate-shaped parts and holding the puncture needle, and a bottom plate part connected to lower ends of the first and second variable plate-shaped parts, the needle protection portion is displaceable between an initial position in which the first and second variable plate-shaped portions are bent, the needle hub and the bottom plate portion are brought close to each other, and the tip of the puncture needle protrudes beyond the bottom plate portion, and a protection completion position in which the first and second variable plate-shaped portions are extended, the tip of the puncture needle is contained between the first and second variable plate-shaped portions, and protection of the puncture needle is completed; The needle protection unit has a resistance generating unit that applies an operational resistance to the displacement and a locking unit that maintains the protection completion position, The resistance generating portion provides a continuous clicking sensation to an operator until the locking portion is activated.

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