JP6359216B1 - Needlestick device and shielding container - Google Patents

Abstract

There is provided a needle stick device capable of lowering a needle to a suitable position of a liquid container while eliminating a positional deviation between the needle and the liquid container. A needle puncture device is provided that punctures a needle body into a lid of a liquid container in which a radioactive liquid is enclosed. In this needlestick device, a mounting table 12 on which a shielding container 5 that contains a liquid container 7 filled with a radioactive liquid and shields leakage of radiation from the liquid is mounted, and a needle body 9 above the mounting table 12. A guide plate 22, a sliding part 23, a frame 24, a guide part 16 and a handle 25, which are needle body moving parts for moving the needle up and down, and a slope 121 on which the shielding container 5 is placed on the mounting table 12. However, the needle stick device is configured to have the engaging portion 14 including the concave portion 13 and the convex portion 15 that are engaged with at least the bottom portion 66 of the shielding container 5. [Selection] Figure 4

Description

The present invention relates to Haritoge device and shielding containers agent liquid stab needle body to a liquid container which is sealed.

  Radiopharmaceuticals using raw materials and radionuclides as materials are synthesized in medical institutions and pharmaceutical manufacturers. The synthesized radiopharmaceutical is administered to a subject to be diagnosed (hereinafter referred to as “subject”), and the state of gathering in the organ or body tissue of the subject is imaged. In known image diagnosis in nuclear medicine, radiopharmaceuticals are enclosed in a single vial or the like for each patient to be administered to a medical institution. The radiopharmaceutical enclosed in the vial is aspirated through a needle pierced in the vial and is taken out and administered to the subject. At this time, in order to avoid the influence of radiation on a person who aspirates or administers the radiopharmaceutical (hereinafter referred to as “surgeon”), the radiopharmaceutical vial is used as a radiation shielding member such as lead (Pb). It is placed in a covered state. As a known technique for sucking a radiopharmaceutical in a state of being covered with a shielding member, for example, there is a radiopharmaceutical suction device described in Patent Document 1.

JP 2006-325826 A

However, in the radiopharmaceutical suction device described in Patent Document 1, a shielding container (container with a shielding material) containing a vial is stored and set in a storage tray. At this time, the vial is in the shielding container and cannot be visually recognized from the outside. Since the container shown in Patent Document 1 is housed obliquely, it is described that most of the medicine can be sucked when the tip of the medicine needle is located at the lower end of the bottom of the vial. On the other hand, if the drug needle is not accurately inserted so that the needle tip is positioned at the low end, the remaining amount of liquid will increase, but the center of the vial may deviate from the side of the container. There was a problem of misalignment.
The present invention has been made in view of the above points, and in the operation of sucking a liquid agent from a liquid container through the needle body, the needle body is removed without displacement of the needle body and the liquid container (vial bottle). It relates to Haritoge device and the shielding container, which can be lowered to a suitable position of the liquid container.

The needle puncture device of the present invention is a needle puncture device that punctures a needle body into a lid of a liquid container in which a radioactive liquid is enclosed, and is a shield that contains the liquid container and shields leakage of radiation from the liquid A mounting table on which the container is mounted; and a needle body moving unit for moving the needle body up and down above the mounting table; and a mounting surface on which the shielding container is mounted on the mounting table. And an engaging part including a concave part or a convex part engaging with at least the bottom part of the shielding container.
The shielding container of the present invention is a radiation shielding container that contains a liquid container filled with a radioactive liquid through which a needle attached to a needle stick device is inserted and is placed on a mounting table of the needle stick device. An accommodating portion for accommodating the liquid container, a wall portion disposed on an outer periphery of the accommodating portion, a shielding member disposed between the accommodating portion and the wall portion, And a bottom surface facing the mounting table at the bottom has an engaging portion that engages with the mounting table .

The present invention can provide a Haritoge device and the shielding container to the needle body and eliminating the misalignment between the liquid container needle body can be lowered to a suitable position of the liquid container.

It is a perspective view for demonstrating the needle stick apparatus of one Embodiment of this invention. It is a front view of the needlestick apparatus shown in FIG. It is the figure which showed the mounting base and base of the longitudinal cross-section which looked at the needlestick apparatus shown in FIG. 2 in the direction of arrow III-III. It is the figure which showed the state which has a needle body in the initial position before a fall start in the needle stick apparatus of FIG. It is the figure which showed the state which fell until the needle body contact | abutted the side wall part of the liquid container in the needlestick apparatus of FIG. (A) is a perspective view of the needle tip surface of one embodiment of the present invention. (B) is a side view of a needle body. (C) is a figure which shows the state which the needle | hook main body shown to (b) deform | transformed. (A), (b), (c) is a figure for demonstrating the behavior of the needle | hook main body of one Embodiment of this invention. It is a perspective view of the shielding container of one Embodiment of this invention. It is the perspective view which showed the bottom part of the container main body shown in FIG. It is a front view of the shielding container shown in FIG. It is a top view of the shielding container shown in FIG. It is a bottom view of the shielding container shown in FIG. (A) is the longitudinal cross-sectional view which looked at the shielding container in the direction which arrow XIII-XIII in FIG. 12 shows. (B) is a longitudinal cross-sectional view for demonstrating the state which mounted the shielding container shown to (a) on the mounting base.

Hereinafter, a needle stick device according to an embodiment of the present invention will be described with reference to the drawings. In all the drawings, the same constituent elements are denoted by the same reference numerals, and redundant description is omitted as appropriate.
[Overview]
The needle puncture device of this embodiment is a device that punctures a needle body into a lid body of a liquid container in which a radioactive liquid (hereinafter also referred to as “liquid agent”) is enclosed. The liquid agent in the liquid container in which the needle body is punctured by the needle puncture device of the present embodiment is sucked by the piston or the like through the needle body and taken out from the liquid container. As the liquid agent, for example, a radiopharmaceutical, a nuclide used for producing the radiopharmaceutical, and the like can be considered. However, the liquid agent is not limited to one having radioactivity, and any liquid agent may be used. However, this needle puncture device is particularly suitable for puncturing a needle body into a liquid container enclosing a small amount of liquid agent. It is.

The lid body into which the needle body is punctured by the needle puncture device may be any member that can puncture the needle body. For example, a resin such as rubber or plastic, a metal film, cork, or the like can be considered. The needle body has only to have a needle hole into which the liquid agent flows and has hardness and strength to penetrate the lid body. As such a needle body, for example, a known injection needle punctured into a living body can be used. In addition, the term “puncture” in the present specification is not limited to piercing a living body with a needle body, but refers to piercing an object so that the needle body penetrates.
In the needlestick device of the present embodiment, the liquid agent is sucked while making the inside of the liquid container have a negative pressure in order to prevent the liquid agent from scattering. In order to create a negative pressure inside the liquid container, in this embodiment, an air needle (not shown) is punctured into the liquid container to suck the air in the liquid container.

[Needlestick device and needlestick system]
FIG. 1 is a perspective view for explaining a needle stick device 1 of the present embodiment. In the present embodiment, in the three-dimensional coordinates shown in FIG. 1, the z direction is indicated as “up” or “upward”, and the −z direction is indicated as “down” or “downward”. In FIG. 1, the gravity direction is downward and the opposite is upward, but this embodiment is not limited to such an example, and does not completely coincide with the z axis or the −z axis. The substantially z direction and the approximately −z direction may be set to the upper side or the lower side, respectively. Furthermore, in the present embodiment, the surface of the needle puncture device 1 in the y direction is referred to as the front surface of the needle puncture device 1, the surface in the −y direction is referred to as the back surface, the surface in the x direction is referred to as the right side surface, and the surface in the −x direction is referred to as the left side surface. .
FIG. 2 is a front view of the needle stick device 1 shown in FIG. In the needlestick device 1 shown in FIG. 2, a shielding container 5 in which a liquid container 7 is accommodated is set. FIG. 3 is a view showing a mounting table 12 and a base 11 in a longitudinal section when the needle stick device 1 shown in FIG. 2 is viewed in the direction of the arrow III-III. 4 and 5 are diagrams showing a needle stick system in which the needle stick apparatus 1 of the present embodiment, the shielding container 5 and the liquid container 7 are combined, both of which are needle bodies attached to the needle stick apparatus 1. 9 shows that it moves up and down. 4 shows a state in which the needle body 9 is in the initial position before the descent start in the needle stick device 1, and FIG. 5 shows the needle body 9 lowered until it contacts the inner surface 72a of the side wall 72 of the liquid container 7. Indicates the state.

As shown in FIGS. 1 to 5, the needle puncture device 1 is a needle puncture device that punctures a needle body 9 into a lid of a liquid container 7 (FIGS. 4 and 5) accommodated in a shielding container 5. In the present embodiment, the needle puncture device 1 is punctured with a needle body 9 in a liquid container such as a vial containing a radiopharmaceutical.
As shown in FIGS. 4 and 5, the needlestick device 1 includes a mounting table 12 on which a shielding container that houses a liquid container 7 containing a radioactive liquid and shields leakage of radiation from the liquid is placed; A needle body moving unit for moving the needle body 9 up and down above the mounting table 12. The inclined surface 121 on which the shielding container 5 is placed on the mounting table 12 has an engaging portion 14 including a concave portion or a convex portion that engages with at least the bottom 66 (FIG. 9) of the shielding container 5.
The mounting table 12 is supported by a base 11 having a larger bottom area than the mounting table 12. In the needle stick device 1 shown in FIG. 1, the guide plate 22, the sliding part 23, the frame body 24, the guide part 16, and the handle 25 constitute a needle moving part. The needle body 9 has a proximal end portion 91 and a needle main body 92.
Furthermore, the needle stick device 1 includes a holding arm 17 and a holding tool 18. The holding arm 17 and the holding tool 18 are positioned so that the needle point 92a of the needle body 9 faces the inner surface 72a (FIG. 6) of the side wall 72 of the liquid container 7 in the shielding container 5 placed on the placing table 12. The needle body 9 is held. The guide plate 22, the sliding part 23, the frame 24, the guide part 16, and the handle 25, which are needle moving parts, move the needle point 92a of the needle body 92 downward, and the needle point 92a abuts against the inner surface 72a. Thereafter, the needle body 9 is lowered further downward.

In the above configuration, “the needle tip 92a of the needle body 9 faces the inner surface 72a of the side wall portion 72 of the shielding container 5” means that a straight line parallel to the axis of the needle body 9 intersects the inner surface 72a. Further, holding the needle body 9 at such a position means that the position of the needle body 9 is determined and held so that a straight line parallel to the axis of the needle body 9 intersects the inner surface 72a. Here, “the inner surface of the side wall portion” refers to a portion of the entire inner surface of the liquid container 7 excluding the inner surface 73 a of the bottom portion 73.
However, as shown in FIGS. 4, 5, etc., when the upper surface of the mounting table 12 is inclined, the shielding container 5 and the liquid container 7 inside thereof are also inclined. At this time, the needle body 92 that descends in the liquid container 7 inevitably moves toward a portion on the tilt direction side of the inner surface 72a of the side wall portion 72. The “tilt direction side” can be, for example, the side of the tilt direction with a plane passing through the center of the bottom 73 of the liquid container 7 and orthogonal to the tilt direction.

In addition to the above-described configuration, the needle stick device 1 of the present embodiment includes a support base 19 that supports the guide plate 22, and a support member 20 that protrudes in the normal direction of the upper surface 19a of the support base 19 and is provided at the tip. 21 (FIG. 4). The guide plate 22, the sliding portion 23, the frame body 24, the guide portion 16, and the handle 25, which are needle moving portions, move the needle body 9 from the highest position where the needle body 9 can move to the lowest position. The support shaft 20 and the buffer member 21 function as a deceleration mechanism that decelerates the moving speed of the needle body 9 before the needle body 9 reaches the lowest position. The support base 19 and the support shaft 20 are set to a height corresponding to the bottom dead center, which is the lowest position that the holding arm 17 that moves up and down can take, and the support base 19 together with the guide plate 22 supports the support shaft 20. Is also supported.
According to such a configuration, for example, the speed at which the needle body 9 descends immediately before the needle tip 92a contacts the inner surface of the liquid container 7 can be reduced, and the impact of the needle tip 92a on the liquid container 7 can be reduced.

  The buffer member 21 may be any member as long as it is a member having strength to withstand the impact received when the frame body 24 reaches the bottom dead center and elasticity to relieve the impact. In the buffer member 21 of the first embodiment, a part of the support shaft 20 is a cylindrical body, and a cylindrical body and a spring having a smaller diameter than the support shaft 20 are inserted into the cylindrical body. Such a buffer member 21 is partially exposed from the support shaft 20 in a state where no pressing force is applied, and when pressed by the frame body 24 that moves together with the needle body 9, the spring contracts and the inside of the support shaft 20 is compressed. It is accommodated in the cylindrical part. Further, when the frame member 24 is raised again and is not pressed, the buffer member 21 is extended from the spring and exposed from the support shaft 20. Such a buffer member 21 reduces the impact of the needle tip 92a on the liquid container 7 by decelerating the moving speed of the frame body 24 by the elastic force of the spring.

  However, the buffer member 21 is not limited to the above configuration. As the buffer member 21, for example, it may be possible to provide rubber, resin, cork, cloth, or the like at the tip of the support shaft 20. By providing the buffer member 21 at the tip of the support shaft 20 that contacts the frame body 24, in this embodiment, when the holding arm 17 reaches the bottom dead center, the frame body 24 hits the support shaft 20 and receives an impact. It is possible to prevent the impact from propagating through the holding arm 17 and to the needle body 9, and to reduce the impact when the needle body 9 contacts the inner surface 73a.

Hereafter, each said structure is demonstrated in order.
(Mounting table)
The mounting table 12 is a table on which a shielding container 5 that houses a liquid container 7 in which a radiopharmaceutical that is a radioactive liquid is enclosed and shields radiation of radiation from the radiopharmaceutical. In addition, as the liquid container 7, for example, a container filled with several mL to several tens of mL of a radioactive drug solution, such as a glass or synthetic resin container having a cylindrical body (vial, prefilled syringe, ampoule, etc.) Can be mentioned.
The mounting table 12 of the present embodiment has an inclined surface 121 that is inclined to the side toward which the inclined surface is directed when the needle body 9 having an inclined surface of the needle tip surface 921 (FIG. 6) that is an end surface on the puncture side is attached. . In the present embodiment, since the entire needle tip surface 921 is an inclined surface, the inclined surface 121 is inclined toward the side toward which the needle tip surface 921 is directed. Here, the “side toward the needle tip surface 921” refers to a range facing the needle tip surface 921.
In the present embodiment, the slope 121 is a surface inclined toward the front. The mounting table 12 on which the shielding container 5 is placed has an engaging portion 14 including a concave portion 13 or a convex portion 15 that engages with at least the bottom 66 (FIG. 9) of the shielding container 5. The mounting table 12 of the present embodiment has a surface in which the bottom surface 13a of the concave portion 13 and the upper surface 15a of the convex portion 15 are in contact with the bottom portion 66 of the shielding container 5 (hereinafter, the bottom surface 13a and the upper surface 15a are also referred to as “mounting surface”). Become.

In this embodiment, the upper surface 15a of the convex part 15 is formed on the same virtual plane as the inclined surface 121, and the upper surface 15a and the inclined surface 121 are flush with each other. A part of the side wall and the bottom of the shielding container 5 are fitted into the recess 13. In this embodiment, the outer edges of the convex portion 15 and the concave portion 13 are concentric circles so that the centers of the convex portion 15 and the concave portion 13 coincide with the center of the slope 121.
With this configuration, the present embodiment can hold the shielding container 5 at the center of the recess 13. For this reason, this embodiment can make the positional deviation amount of the shielding container 5 and the recessed part 13 smaller than the structure which hold | maintains the shielding container 5 with the outer edge of the recessed part 13, for example.

  That is, when placing the shielding container 5 in the bottom surface 13 a of the recess 13, the diameter of the recess 13 is designed so that the operator can easily place the shielding container 5 in the recess 13 manually. For this reason, the diameter of the recess 13 is designed to have a margin larger than the diameter of the bottom 66 of the shielding container 5, and a gap is generated between the peripheral wall surface (outer edge) of the recess 13 and the side periphery of the bottom 66. become. In such a configuration, for example, when the storage tray that houses the shielding container 5 is tilted like the radiopharmaceutical suction device described in Patent Document 1, the shielding container 5 is supported by the outer edge of the recess 13. Thus, the gap between the concave portion 13 and the bottom portion 66 is biased toward the higher side of the slope 121. However, when the shielding container 5 is supported near the center in the recess 13 as in this embodiment, the gap between the recess 13 and the bottom 66 can be evenly generated on both the high side and the low side of the slope 121. it can. For this reason, in the present embodiment, the bottom 66 can be accurately aligned with the center of the recess 13 regardless of the tolerance of the recess 13. Although the shielding container 5 is a member that is heavy and easily distorted because the shielding member is incorporated, according to the present embodiment, the center of the shielding container 5 can be moved even if distortion occurs. Absent. For this reason, the present embodiment can stabilize the needle stick device 1.

  In the present embodiment, at least a part of the bottom surface 13a and the top surface 15a may be roughened. The roughening can be realized by blasting such as sand blasting, shot blasting, and grit blasting. The roughening can also be realized by making the mounting table 12 of a metal such as stainless steel and leaving the polishing marks when the bottom surface 13a is cut out without being flattened. In the present embodiment, the bottom surface 13a of the placement surface is roughened. Such a configuration can increase the frictional force between the bottom surface 13 a and the bottom portion 66 and increase the holding force of the shielding container 5 by the engaging portion 14.

(Needle holding part)
As described above, the holding arm 17 and the holding tool 18 constitute a needle holding unit in the needle stick device 1. The holding arm 17 includes a holding groove 184 that protrudes from the frame body 24 toward the front and sandwiches the needle body 9 at a position above the engaging portion 14. A holding tool 18 is attached to the holding arm 17 with a screw 182, and a holding groove 181 is formed in the holding tool 18. The holder 18 is attached to the holding arm 17 so that the holding groove 184 and the holding groove 181 face each other, and the needle body 9 is sandwiched between the holding groove 184 and the holding groove 181 and fixed.

  As described above, the mounting surfaces (the bottom surface 13a and the upper surface 15a) on which the shielding container 5 is mounted on the mounting table 12 are inclined surfaces that are inclined in one direction. The bottom surface 13 a and the top surface 15 a of the present embodiment are inclined toward the front side (y direction) of the needlestick device 1. In addition, the tip of the needle body 92 has a slope that intersects the axial direction of the needle body 92, and in the present embodiment, this slope is hereinafter referred to as a “needle tip surface”. As shown in FIG. 4, the holding arm 17 and the holding tool 18 hold the needle body such that the needle tip surface is inclined, that is, the inclination direction of the bottom surface 13 a and the top surface 15 a.

FIGS. 6A, 6 </ b> B, and 6 </ b> C are schematic diagrams for explaining the needle tip surface 921 of the needle body 92. 6A is a perspective view of the needle tip surface 921, and FIG. 6B is a side view of the needle body 92 shown in FIG. 6A. FIG. 6C is a diagram illustrating a state in which the needle body 92 illustrated in FIG. 6B is deformed (bent). As shown in FIG. 6A, the needle body 92 of the needle body 9 has a needle hole 922 and a needle tip surface 921 that intersects the needle hole 922. The inclined needle tip surface 921 is provided on the needle main body 92 mainly for the purpose of sharpening the needle tip 92a and reducing the force required for the needle main body 92 to puncture the lid 71. . The normal vector Vn shown in FIGS. 6A to 6C indicates the normal direction of the needle tip surface 921. 6B and 6C, it can be seen that the needle main body 92 is a deformable member, and the direction of the needle tip surface 921 changes depending on the deformation of the needle main body 92.
In the above description, “the needle tip surface 921 faces the inclination direction of the bottom surface 13a and the upper surface 15a” means that the needle body 92 is lowered and at least a part of the needle tip surface 921 is in surface contact with the inner surface 72a. The direction of the front surface 921 is said. That is, in this embodiment, the direction of the needle main body 92 is not limited to the direction in which the entire surface of the needle tip surface 921 is in contact with the inner surface 72a, and a state in which part of the needle main body 92 is not in surface contact is allowed. Such a state of the needle tip surface 921 can be realized by equalizing the angle formed between the inner surface 73a of the liquid container 7 and the needle body 92 and the angle formed between the inclined surface 121 and the needle body 92.

  In the present embodiment, a holding guide portion for holding the needle body 9 may be provided on the holding arm 17 and the holding tool 18 so that the needle tip surface 921 is directed in the tilt direction. As the holding guide portion, for example, a mark 183a shown in FIG. 1 can be used. The mark 183a may have any function as long as it has a function of indicating an inclination direction in which the needle tip surface 921 is directed when the operator manually sandwiches the needle body 9 between the holding groove 181 and the holding groove 184, for example. Further, the mark 183a may include text information or the like indicating that the direction of the needle body is specified together with a symbol indicating the direction. Further, in the first embodiment, as shown in FIGS. 4 and 5, a mark 183b is also formed on the side of the needle body 9, and the needle body 9 is inserted into the needle body 9 so that the operator aligns the mark 183b and the mark 183a. You may make it set to the apparatus 1. FIG.

  Moreover, this embodiment is not limited to using a mark for a holding guide part. For example, in the holding guide portion, the holding groove 184 may have a concave portion or a convex portion, and the needle body 9 side may have a concave portion or a convex portion corresponding to the concave and convex portions of the holding groove 184. Further, in the present embodiment, when the needle body 9 has a function of automatically setting the needle stab apparatus 1, the needle body 9 automatically sets the needle tip surface 921 with the bottom surface 13a and the top surface 15a being inclined. You may be made to do.

(Needle moving part)
As described above, the guide plate 22, the sliding part 23, the frame body 24, the guide part 16, and the handle 25 constitute a needle moving part in the needle stick device 1. The guide plate 22 is a rectangular plate-like member as a whole, and is erected on the support base 19 so that the long side direction is directed upward. Rail portions 221 are formed on the two long sides of the guide plate 22. The sliding portion 23 is a member that slides on the guide plate 22 while fitting with the guide plate 22. The sliding portion 23 is a fitting portion in which a plate-like portion 23a that overlaps the front face (y-direction) of the guide plate 22 and a rail portion 231 that fits the rail portion 221 of the plate-like portion 22a are formed. 23b, and is configured to be slidable along the rail portion 221. The sliding portion 23 is fixed to the front surface of the inner peripheral surface of the frame body 24. A holding arm 17 is fixed to the frame body 24.
The handle 25 is a member that is gripped by an operator and is fixed to the frame body 24. When the operator holds the handle 25 and moves it upward, the frame body 24 and the sliding portion 23 rise together with the handle 25. When the holding arm 17 rises with the frame body 24 and is at the highest position that the handle 25 can take, the holding arm 17 and the needle body 9 held by the holding arm 17 reach the initial position before starting to descend.

  As shown in FIGS. 4 and 5, the shielding container 5 of this embodiment is placed on the bottom surface 13 a and the top surface 15 a formed on the slope 121, and the shielding container 5 and the liquid container 7 are inclined on the slope 121. Inclined in the direction. With respect to the liquid container 7 in the shielding container 5, in this embodiment, the operator releases the handle at the highest position or weakens the gripping force to lower the frame body 24 and the holding arm 17 in the vertical direction. Let At this time, the needle body 9 descends along an axis that intersects the inner surface 72 a of the liquid container 7. Then, the needle main body 92 is inserted into the liquid container 7 through the guide groove 161 of the guide portion 16. The guide part 16 of this embodiment is comprised with the metal plate, and has elasticity. Such a guide portion 16 prevents the holding arm 17 from colliding with the shielding container 5 when the holding arm 17 reaches a position lower than the original bottom dead center because the buffer member 21 is broken. Can do. Moreover, the guide part 16 can show an operator the position where the needle body 9 descends.

Hereinafter, the operation of the needle moving unit of the present embodiment will be described in more detail.
FIGS. 7A, 7 </ b> B, and 7 </ b> C are diagrams for explaining the behavior of the needle main body 92 in the liquid container 7. However, FIG. 7C is exaggerated for easy understanding.
As shown in FIG. 7A to FIG. 7C, the liquid container 7 has a side wall portion 72 and a bottom portion 73 following the side wall portion 72. The inner surface of the side wall portion 72 is shown as an inner surface 72a, and the inner surface of the bottom portion 73 is shown as an inner surface 73a. The liquid container 7 contains a radiopharmaceutical L, and the radiopharmaceutical L in the liquid container 7 is sealed in the liquid container 7 by a lid 71.
As described above, the holding arm 17 and the holding tool 18 hold the proximal end portion 91 of the needle body 9 so that the needle tip surface 921 of the needle main body 92 faces the inner surface 72a. In the process of descending the liquid container 7 in such a state, the needle main body 92 contacts the inner surface 72a of the side wall portion 72 as shown in FIG. At this time, the needle tip surface 921 of the needle body 92 is in a state of being close to the inner surface 72a.

In the needle stick device 1 of the present embodiment, the moving range of the frame body 24 is set so that the needle tip surface 921 moves down without changing the moving direction even after it contacts the inner surface 72a. The “movement direction” here is the movement direction of the needle body 9 by the frame body 24. As the needle body 9 continues to move downward, the needle body 92 is deformed while contacting the inner surface 72a as shown in FIG. 7B. When the frame body 24 is further lowered, a reaction force from the bottom 73 is applied, so that a larger force is applied to the needle body 92 in the liquid container 7. Therefore, as shown in FIG. 7C, the needle body 92 is further deformed so that the needle tip surface 921 moves along the inner surface 73a.
In this embodiment, since the needle body 92 strikes the inner surface 72a at an angle, the force applied to the liquid container 7 by the needle body 92 becomes a component force corresponding to the entry angle of the needle body 9. Accordingly, in the present embodiment, the impact applied to the liquid container 7 is made smaller than the configuration in which the needle tip 92 a is in contact with the bottom 73 of the liquid container 7 in the vertical direction, and the needle tip 92 a contacts the liquid container 7. At that time, the possibility of damage to the liquid container 7 can be reduced.

As shown in FIGS. 6B and 6C, the direction of the normal vector Vn of the needle tip surface 921 changes according to the state of deformation of the needle body 92. In the configuration in which the needle body 92 is deformed along the inner surface 73a of the bottom portion 73 after the needle body 92 abuts on the inner surface 72a of the side wall portion 72 as in the present embodiment, the normal vector Vn of the needle tip surface 921 is Until 92 abuts on the inner surface 72a of the side wall portion 72, the needle body 9 moves toward the inner surface 73a and further moves downward toward the inner surface 73a of the bottom portion 73.
In the above description, “the normal vector Vn of the needle tip surface 921 faces the inner surface 72a” means a state in which the normal vector Vn intersects the inner surface 72a. Further, “the normal vector Vn of the needle tip surface 921 is directed toward the inner surface 73a” refers to a state in which the normal vector Vn is in a direction intersecting with the inner surface 73a.

In other words, the needle main body 92 is pressed and bent by the inner surface 72 a of the side wall portion 72, and the needle moving portion further lowers the needle body 9 so that at least a part thereof is in contact with the inner surface 73 a of the bottom portion 73. Become. Here, “bend” means that the elastic member is deformed according to the magnitude and direction of the applied force, and is substantially returned to the state before the force is applied after being released from the force. . However, the needle body 92 is not limited to bend as shown in FIG. 7C, and may be deformed from above the contact point of the inner surface 72a.

  According to the above operation, the needle tip surface 921 moves toward and approaches the inner surface 73a of the bottom portion 73 as the needle main body 92 descends in the liquid container 7. Further, in the present embodiment, the liquid container 7 is set to be inclined in one direction, and the water depth of the radiopharmaceutical L in the liquid container 7 is deepest at the end portion of the bottom portion 73 in the inclination direction, and so far away from the end portion. It becomes shallower. According to the configuration of the present embodiment, the needle tip surface 921 becomes lower as it moves away from the deeper end of the water depth, so that a small amount of the radiopharmaceutical L remaining on the bottom 73 of the liquid container 7 can be sufficiently sucked. . Moreover, since the needlestick apparatus 1 of this embodiment can implement | achieve the said operation | movement only by lowering | hanging the needle body 9, the residual amount of a radiopharmaceutical is stored in the liquid container 7 accommodated in the shielding container 5 and an internal state cannot be visually recognized. It is suitable for reducing.

  In addition, the needle stick apparatus 1 of this embodiment is not limited to the structure demonstrated above. That is, in the present embodiment, the example in which the liquid container 7 is tilted and the needle body 9 is lowered in the vertical direction is shown. However, in the present embodiment, the needle body 9 is directed toward the side wall portion 72 without tilting the liquid container 7. And may be lowered diagonally. Even in such a configuration, the position of the needle tip surface 921 of the needle body 92 is lower than that in the known configuration, so that the residual amount remaining in the liquid container 7 after the radiopharmaceutical is extracted can be reduced. Furthermore, the needle stick device 1 of the present embodiment is not limited to the configuration in which one of the needle body 9 or the liquid container 7 is inclined, and the needle tip 92a of the needle body 9 is directed toward the inner surface 72a of the side wall portion 72 of the liquid container 7. Any structure may be used as long as it applies more force after moving and contacting the side wall 72.

[Shielding container]
Next, the shielding container of this embodiment will be described.
The shielding container 5 of the present embodiment is any type as long as it has the function of accommodating the liquid container 7 and reducing the leakage of radiation emitted from the radiopharmaceutical in the liquid container 7. May be. However, as long as the liquid container 7 is accommodated therein, the shielding container 5 has a lid and a main body, and includes an accommodating portion for accommodating the liquid container 7 inside the main body. From the viewpoint of workability when the liquid container 7 is accommodated or taken out and prevention of breakage of the liquid container 7, the accommodating portion desirably does not adhere to the liquid container 7 and has a volume sufficient to fix the liquid container 7. . Moreover, it is desirable that the shielding container 5 is configured to cover the accommodating portion with a member (shielding member) having a function of shielding radiation from the viewpoint of reducing the amount of radiation leakage. As a material for the shielding member, for example, lead (Pb) or tungsten (W) is desirable.
The shape of the lid and the main body is not particularly limited, but it is desirable that the shape is easy for an operator to handle and can be easily accommodated in transportation or the like (a plurality of shielding containers 5 can be arranged without gaps). In this embodiment, the following shielding container 5 is illustrated as a shielding container which satisfy | fills such conditions.

  FIG. 8 is a perspective view of the shielding container 5 of the present embodiment, and shows a state in which the container lid 51 is removed from the container main body 56. FIG. 9 is a perspective view showing the bottom 66 of the container body 56 shown in FIG. 10 is a front view of the shielding container 5, FIG. 11 is a top view of the shielding container 5, and FIG. 12 is a bottom view of the shielding container 5. Fig.13 (a) is the longitudinal cross-sectional view which looked at the shielding container 5 in the direction which the arrow XIII-XIII in FIG. 12 shows. FIG. 13B is a longitudinal sectional view for explaining a state in which the shielding container 5 shown in FIG. 13A is placed on the placing table 12. 8 to 12, x, y, and z coordinates are shown. The front view of the shielding container 5 in this embodiment is a view of the shielding container 5 viewed from the y direction, the top view is a view of the shielding container 5 viewed from the z direction, and the bottom view is a shielding container viewed from the −z direction. FIG.

The shielding container 5 is a radiation shielding container that contains a liquid container 7 filled with a radiopharmaceutical through which the needle body 9 attached to the needle stick device 1 is inserted and is placed on the mounting table 12 of the needle stick device 1. is there. As shown in FIG. 8, the shielding container 5 includes a container body 56 and a container lid body 51 that is a screw lid of the container body 56. As shown in FIGS. 8 to 11, the container main body 56 includes a storage portion 6 for storing the liquid container 7, a container side wall portion 57 that is a wall portion disposed on the outer periphery of the storage portion 6, and a storage portion. 6 and the container side wall portion 57, and a bottom portion 66 of the container side wall portion 57. The shielding container 5 has an engaging portion 69 in which a bottom surface 68 c facing the mounting table at the bottom 66 is engaged with the mounting table 12. Further, the bottom surface 68c of the shielding container 5 has protrusions 68a and 68b and engaging portions 69 which are contact portions that come into contact with the mounting table 12 with an area smaller than the bottom surface 68c. In addition, in this embodiment, the part which is elongate and protrudes in strip | belt shape rather than the periphery is called a protruding item | line.
The container body 56 is obtained by applying a plastic outer container 570 to a shielding member 101 made of a substantially bottomed cylindrical radiation shielding metal (lead alloy, tungsten alloy, etc.) having a housing 6 for a radioactive liquid container. The container side wall 57 described above is a part of the outer container 570 provided on the side surface of the shielding member 101.

  The “bottom surface” as used in the present embodiment is a lower surface of the bottom portion 66 and is a virtual surface in a state where the protrusions 68a and 68b and the engaging portion 69 are not present. In FIG. 9 and FIG. 12, for convenience, a portion of the surface of the bottom portion 66 that does not have any of the protrusions 68 a and 68 b and the engagement portion 69 is shown as a bottom surface 68 c.

  As shown in FIGS. 8 and 13A, the container body 56 is obtained by applying a plastic outer container 570 to the shielding member 101. An inclined portion 55 is formed on the outer periphery of the opening of the container main body 56 so that the liquid container 7 can be easily accommodated in the accommodating portion 6 without hitting the container main body 56. The outer container 570 includes an overhang 54 on the outer periphery of the inclined portion 55, and a screw groove 541 for fixing the container lid 51 is formed on the outer peripheral surface of the overhang 54. The exterior container 510 of the container lid 51 includes a thread groove 531 that engages with the thread groove 541 on the inner surface.

  Further, a liquid container holding piece 70 is formed on the peripheral surface of the accommodating portion 6 so as to contact the peripheral surface of the body portion of the liquid container 7 for a predetermined length along the axial direction. An engaging portion 82 of the liquid container holding piece 70 is engaged with the opening of the container main body 56, whereby the liquid container holding piece 70 is disposed in the storage portion 6. In such a configuration, the contact distance in the vertical direction (the axial direction of the liquid container) between the liquid container 7 and the liquid container holding piece 70 is relatively long. Therefore, when the liquid container 7 is fixed inside the liquid container holding piece 70 The liquid container 7 does not wobble, and the liquid container 7 can be stably held in the container body 56. In the present embodiment, the liquid container holding piece 70 is formed of plastic, but the material of the liquid container holding piece is not limited, and can be formed of rubber, metal, paper, or the like.

  The container lid 51 is not limited to the screw lid of the container main body 56, and the liquid container holding piece 70 is limited to be engaged with the opening of the container main body 56 by the engaging portion 82. is not. There is no limitation to such means, and means can be adopted as appropriate.

Further, the container lid 51 is obtained by applying a plastic outer container 510 to a shielding member 100 made of radiation shielding metal similar to the shielding member 101. In the container lid 51, a plastic exterior portion 81 is also formed on the inner surface facing the container body 56. The container lid 51 includes a small-diameter lid portion 52 having a predetermined diameter, a large-diameter lid portion 53 having a larger diameter than the small-diameter lid portion 52, and an inclined lid portion 52b that connects the small-diameter lid portion 52 and the large-diameter lid portion 53. have.
In the shielding container 5, the shielding member 101 needs to be sufficiently thick in order to sufficiently shield radiation. If the diameter of the container lid 51 is increased in order to correspond to the thickness dimension of the shielding member 101, it is difficult for the operator to grip the container lid 51 and the container lid 51 is difficult to open. The above configuration is made in consideration of such points, and the container lid 51 is configured by a large-diameter lid portion 53 having a diameter corresponding to the shielding member 101 and a small-diameter lid portion 52 that is easy to grip. Yes. In the present embodiment, since the inclined lid portion 52b is formed between the small diameter lid portion 52 and the large diameter lid portion 53, the container lid body 51 is used when the operator holds the container lid body 51 from above. It is easy to fit in your hand.
Further, a plurality of vertical grooves 52 a are formed around the small-diameter lid portion 52 so that the operator can easily grasp the small-diameter lid portion 52. A plurality of vertical grooves 53 a are formed around the large-diameter lid portion 53.

  The shielding container 5 of the present embodiment is provided after the liquid container 7 is accommodated in the accommodating portion 6 and sealed. The front view of FIG. 10 shows a state where the shielding container 5 is sealed, and a sealing portion 53 b is provided below the large-diameter lid portion 53. The sealing portion 53 b is opened when the operator holds the pull tab 53 c and applies a force in the circumferential direction of the large-diameter lid portion 53. After opening, the shielding container 5 becomes separable into a container lid 51 and a container body 56 as shown in FIG.

As shown in FIGS. 9 and 12, the engaging portion 69 is a concave portion that engages with the convex portion 15 of the needle stick device 1, and the concave surface 69 a is a contact surface that contacts the upper surface 15 a of the convex portion 15. Yes. In the present embodiment, by providing such a contact surface, the shielding container 5 can be fixed to the inclined surface even if the bottom surface 13a and the upper surface 15a are inclined surfaces. In the present embodiment, the engaging portion 69 is formed at a central position including the center of the bottom surface 68c. For this reason, as shown in FIG. 13B, the shielding container 5 is held at a position including the center of the bottom surface 68c, with the engaging portion 69 engaging with the convex portion 15 on the bottom surface 13a and the top surface 15a of the slope. Become so.
The shielding container 5 of the present embodiment is naturally placed at the center of the concave portion 13 of the needle stick device 1 by arranging the engaging portion 69 at the center of the bottom portion 66. In addition, such a configuration is, for example, compared with a configuration in which the shielding container 5 is held only at the outer edge portion even when the shielding container 5 is displaced in the inclination direction of the inclined surface when the bottom surface 13a and the upper surface 15a are inclined surfaces. The amount of displacement can be reduced. Such an effect is effective in a configuration that strictly defines the direction and amount of lowering the needle body 9 as in the needle stick device 1.

Moreover, as shown in FIGS. 9 and 12, the shielding container 5 of the present embodiment has ridges 68 a and 68 b that are contact portions. The ridges 68a are one or a plurality of ridges that form a line segment passing through the center (not shown) of the bottom surface 68c. The ridges 68b are one or more ridges that form a circle centered on the center (not shown) of the bottom surface 68c. In the present embodiment, a plastic net structure is formed by combining the ridge 68a and the ridge 68b. The net structure is flexible because the widths of the protrusions 68a and 68b are relatively narrow (thin), and the protrusions 68a and 68b intersect with each other, so that the bottom 66 is prevented from being deformed in the radial direction. Is granted. Such a net structure functions as a cushioning material that prevents the outer container 570 from cracking due to the weight of the shielding member 101 even when the shielding container 5 is dropped on a hard surface or placed with a strong force.
Since the ridges 68a and 68b are formed in the process of injection-molding the exterior container 570, the manufacturing process of the shielding container 5 can be suppressed by omitting the process of separately forming the buffer material.

  The mechanism functioning as the cushioning material is not limited to the convex strip having a shape formed by combining the concentric circles shown in FIGS. 9 and 12 and radial straight lines. The mechanism formed in the bottom 66 may be any shape of protrusion or groove as long as it can withstand the weight of the shielding member 101 and reduce the impact applied to the shielding container 5. The width and number of the ridges or grooves and the fineness of the net structure are determined in consideration of the assumed impact, the hardness of the plastic, and the like.

  In the needle puncture device, the shielding container, and the needle puncture system of the present embodiment described above, when the operator places the shielding container 5 on the needle puncture device 1, the shielding container 5 is placed in accordance with the recess 13. Become. At this time, the shielding container 5 engaging portion 69 is engaged with the convex portion 15 of the slope 121, and the shielding container 5 can be positioned. For this reason, according to the present embodiment, the needle body can be lowered to a suitable position of the liquid container without displacement of the needle body and the liquid container.

Next, an example in which the radiopharmaceutical fludeoxyglucose ( ¹⁸ F) injection solution ( ¹⁸ F-FDG) is extracted from the liquid container 7 accommodated in the shielding container 5 using the needlestick device 1 described above. The effects of the present invention will be described. In addition, extraction of the holder 18 was performed by making the inside of a vial bottle into a normal pressure in order to prevent ¹⁸ F-FDG scattering.

(Example 1) Confirmation of residual rate by weight measurement Ten 5 mL vials were prepared, and tares were measured (9.443374 to 9.66846 mg), respectively. About 5 mL of ¹⁸ F-FDG was sealed in each 5 mL vial, and the total weight of the combined ¹⁸ F-FDG and vial was measured. The needle tip surface 921 is directed to a portion of the inner surface of the vial that is inclined (hereinafter referred to as “positive direction”), then descends and the ¹⁸ F-FDG is extracted, and the weight of the vial is measured. Then, the residual amount and the residual ratio were obtained from the following equations.
Residual amount (mL) = [total weight before extraction (mg) −tare (mg)] − [total weight before extraction (mg) −vial weight after extraction (mg)]
Residual rate (%) = [residual amount (mL) / {total weight before extraction (mg) −tare (mg)}] × 100
As a result of extracting ¹⁸ F-FDG from each 5 mL vial, the average value of the residual amount was 0.00870 mL, and the maximum value was 0.01929 mL. Moreover, the average value of the residual rate was 0.3980%, and the maximum value was 0.8826%.

(Example 2) Confirmation of residual rate by radioactivity measurement [1]
The effect of causing the needle tip surface 921 in the positive direction of the needle body 9 described in the embodiment to face the inner surface 72a of the side wall portion 72 of the vial was measured using the amount of radioactivity (MBq).
Specifically, nine 5 mL vials were prepared, each 2.2 mL vial was sealed with about 2.2 mL of ¹⁸ F-FDG, the amount of radioactivity was measured, and the 5 mL vial before extraction was taken out. Attenuation was corrected at the time (after attenuation correction: 364.6 to 443.0 MBq). Thereafter, ¹⁸ F-FDG is extracted, and the radioactivity of the 5 mL vial after the ¹⁸ F-FDG is extracted is measured, and attenuation correction is performed at the time before extraction of the reference 5 mL vial to obtain the residual amount. It was. Moreover, the residual rate was calculated | required from the following formula | equation.
Residual rate (%) = [residual amount (MBq) / radioactivity before sampling (MBq)] × 100
As a result, the average value of the residual amount was 4.2 MBq, the median value was 4.2 MBq, and the maximum value was 5.4 MBq. Further, the average value of the residual ratio was 1.05%, and the maximum value was 1.37%.

(Example 3) Confirmation of residual rate by radioactivity measurement [1]
^The amount of radioactivity after attenuation correction measured for a 5 mL vial filled with ¹⁸ F-FDG is 279.5 MBq to 330.1 MBq, and the needle tip surface 921 is opposite to the portion of the inner surface of the vial in the tilt direction. The residual amount and the residual rate were determined in the same manner as in Example 2 except that the sample was lowered toward the side (hereinafter referred to as “reverse direction”) and ¹⁸ F-FDG was extracted.
As a result of extracting ¹⁸ F-FDG from each 5 mL vial, the average value of the residual amount was 6.5 MBq, the median value was 5.0 MBq, and the maximum value was 9.6 MBq. Moreover, the average value of the residual rate was 2.15%, and the maximum value was 3.16%.

  As a result of evaluating the residual ratio of Example 2 and Example 3 by t-test, the variance when the needle tip surface 921 is in the forward direction is 0.88, and the variance when the needle tip surface 921 is in the reverse direction is 4. 67, the Pearson correlation between the two is 0.88, the t value is 3.091, the significance (p value) is 0.0070, and the p value is 0.01 or less. There was a statistically significant difference in the residual rate.

The above embodiments and examples include the following technical ideas.
<1> A needle puncture device that punctures a needle body into a lid of a liquid container in which radioactive liquid is sealed, and a shielding container that houses the liquid container and shields leakage of radiation from the liquid is placed thereon And a needle body moving unit for moving the needle body up and down above the mounting table, and the mounting surface on which the shielding container is mounted on the mounting table is a surface of the shielding container. A needle stick device having an engaging portion including a concave portion or a convex portion engaging with at least a bottom portion.
<2> The needle puncture device according to <1>, wherein the placement surface is a slope inclined to a side toward which a puncture side end surface of the needle body is directed when the needle body is attached.
<3> The needle stick device according to <1> or <2>, wherein at least a part of the placement surface is roughened.
<4> A radiation shielding container which contains a liquid container filled with a radioactive liquid through which a needle attached to a needle stick device is inserted and which is placed on a mounting table of the needle stick device, wherein the liquid An accommodating portion for accommodating a container; a wall portion disposed on an outer periphery of the accommodating portion; a shielding member disposed between the accommodating portion and the wall portion; and a bottom portion of the wall portion. A shielding container having a bottom surface facing the mounting table at the bottom and having an engaging portion that engages with the mounting table.
<5> It further has a contact portion that contacts the mounting table by an area smaller than the bottom surface, and the contact portion includes one or more ridges that form a line segment passing through the center of the bottom surface, and the center. <4> The shielding container, which is one or a plurality of ridges forming a circle centered on the surface.
<6> A needle puncture system that punctures a needle body into a lid of a liquid container in which radioactive liquid is enclosed, and a shielding container that contains the liquid container and shields leakage of radiation from the liquid container to the outside. A needle body for sucking the liquid in the liquid container, and a needle body moving unit for moving the needle body up and down above the mounting table, wherein the shielding container is mounted on the mounting table. The mounting surface includes an engaging portion including a concave portion or a convex portion that engages with at least the bottom portion of the shielding container, and the bottom surface of the shielding container that faces the mounting table has a smaller area than the bottom surface. A needlestick system having a contact portion that contacts the portion.

DESCRIPTION OF SYMBOLS 1 ... Needle stick device 5 ... Shielding container 6 ... Storage part 7 ... Liquid container 9 ... Needle body 11 ... Base 12 ... Mounting table 13 ... Recessed part 13a ..Bottom surface 14 ... engaging portion 15 ... convex portion 15a ... upper surface 16 ... guide portion 17 ... holding arm 18 ... holding tool 19 ... support base 19a ... upper surface 20 ... support shaft 21 ... buffer member 22 ... guide plates 22a, 23a ... plate-like part 23 ... sliding part 23b ... fitting part 24 ... frame 25 ... -Handle 51 ... Container lid 52 ... Small diameter lid 52a, 53a ... Vertical groove 52b ... Inclined lid 53 ... Large diameter lid 53b ... Sealing portion 53c ... Pull tab 54 ... Overhang 55 ... Inclination 56 ... Container body 57 ... Container side wall 66 ... Bottom 68a, 68b ... Projection 68c ... Surface 69 ... engaging portion 69a ... concave surface 70 ... liquid container holding piece 71 ... lid body 72 ... side wall 72a, 73a ... inner surface 73 ... bottom 81 ... exterior Part 82 ... engaging part 91 ... proximal end part 92 ... needle body 92a ... needle tip 100, 101 ... shielding member 121 ... slope 161 ... guide grooves 181, 184 ··· Holding groove 182 ··· Screws 183a and 183b ··· Marks 221 and 231 ··· Rail portions 531 and 541 · · · Screw grooves 510 and 570 · · · Exterior container 921 · · · Needle tip surface 922 ···・ Needle hole

Claims (5)

A needle stick device for piercing a needle body into a lid of a liquid container in which a radioactive liquid is enclosed,
A mounting table on which a shielding container that houses the liquid container and shields leakage of radiation from the liquid is mounted;
A needle body moving part for moving the needle body up and down above the mounting table,
The needle stick device, wherein the placement surface on which the shielding container is placed in the placement table includes an engaging portion including a concave portion or a convex portion that engages with at least a bottom portion of the shielding container.   2. The needle puncture device according to claim 1, wherein the placement surface is an inclined surface that is inclined toward a side toward which the inclined surface is directed when the needle body having an inclined surface on the puncture side is attached.   The needlestick device according to claim 1 or 2, wherein at least a part of the placement surface is roughened. A radiation shielding container that contains a liquid container filled with a radioactive liquid through which a needle attached to a needle stick device is inserted, and is placed on a mounting table of the needle stick device,
An accommodating portion for accommodating the liquid container; a wall portion disposed on an outer periphery of the accommodating portion; a shielding member disposed between the accommodating portion and the wall portion; and a bottom portion of the wall portion. Have
The bottom face which goes to the mounting base in the said bottom part has an engaging part engaged with the said mounting base, and is a shielding container.   The contact portion that contacts the mounting table by an area smaller than the bottom surface is further provided, and the engaging portion is provided with a concave surface that engages with the mounting table, and the contact portion is a center of the bottom surface. The shielding container according to claim 4 which is one or a plurality of ridges which form a line segment which passes through, and one or a plurality of ridges which form a circle centering on the center.

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