Drug administration device

Abstract

To prevent damage to a syringe unit attributed to an impact in a process of a puncture operation by a medical solution administering device.SOLUTION: A medical solution administering device 12D includes a speed reduction mechanism 400 for reducing a moving speed of a syringe unit before the connection between the tip of the syringe unit and a second needle part is completed after a second needle part 114 of a double-hook needle 22 starts to stick in the tip of the syringe unit when the syringe unit 20D including a syringe 68 moves toward the tip direction of a housing 16.SELECTED DRAWING: Figure 55

Description

Technical Field

[0001] The present invention relates to a chemical solution administration device that administers a chemical solution to a puncture target punctured with a double-headed needle.

Background Art

[0002] Conventionally, a portable chemical solution administration device for puncturing the skin of a patient to be administered and administering a chemical solution used for subcutaneous injection has been known. The chemical solution administration device of Patent Document 1 accommodates a cartridge filled with a chemical solution and a needle holder holding a needle inside a main body formed in a cylindrical shape. The needle and the needle holder are arranged in the distal direction with respect to the cartridge, and the needle is a double-headed needle that protrudes in the distal direction and the proximal direction with respect to the needle holder.

[0003] When administering a chemical solution using the chemical solution administration device, the needle is biased toward the cartridge together with the needle holder by the elastic force of a spring, and when the needle holder moves toward the cartridge, the proximal end portion of the needle is inserted into the cartridge. Thereby, the end portion of the needle and the cartridge are connected, and when the needle holder further moves and abuts against the end portion of the cartridge, the connection between the needle and the cartridge is completed.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] In the drug administration device described in Patent Document 1, when the needle holder holding the needle moves toward and contacts the cartridge, the cartridge is subjected to an impact from the needle holder. If the cartridge is made of glass, there is a concern that the cartridge may break. Even if the cartridge is made of plastic, it becomes extremely brittle in low-temperature environments, so there is a concern that it may break due to the impact described above.

[0006] The present invention aims to solve the problems described above. [Means for solving the problem]

[0007] One aspect of the present invention is a housing formed in the shape of a hollow cylinder, A syringe unit having a barrel filled with a drug solution and movable towards the tip by the biasing force of a biasing member within the housing, A double-ended needle having a first needle portion that protrudes toward the tip and punctures the target to be punctured, and a second needle portion that protrudes toward the proximal end toward the syringe unit, A needle hub that holds the double-ended needle, A stopper that, after the syringe unit moves toward the tip due to the biasing force of the biasing member and the second needle portion begins to penetrate the tip of the syringe unit, stops the syringe unit at a predetermined position to complete the connection between the tip of the syringe unit and the second needle portion, A drug solution dispensing device equipped with, When the syringe unit moves toward the tip, a deceleration mechanism is provided to reduce the movement speed of the syringe unit after the second needle portion begins to penetrate the tip of the syringe unit but before the connection between the tip of the syringe unit and the second needle portion is completed. [Effects of the Invention]

[0008] According to the present invention, the following effects can be obtained.

[0009] In other words, during the puncture procedure using the drug administration device, when the syringe unit moves toward the tip along the housing, the deceleration mechanism reduces the movement speed of the syringe unit, thereby mitigating the impact the syringe unit receives when it comes into contact with the stopper and stops. As a result, damage to the syringe unit caused by impact can be prevented. [Brief explanation of the drawing]

[0010] [Figure 1] This is an external perspective view of the drug administration system relating to the first configuration. [Figure 2] This is a disassembled perspective view of the drug administration system shown in 1. [Figure 3] Figure 1 is a perspective view of the drug dispensing device in the drug dispensing system. [Figure 4] This is an exploded perspective view of the drug administration device shown in 3. [Figure 5] This is a cross-sectional view along the VV line in Figure 3. [Figure 6] Figure 5 is an enlarged cross-sectional view showing the vicinity of the proximal end of the drug dispensing device. [Figure 7] This is a cross-sectional view along line VII-VII in Figure 3. [Figure 8] Figure 7 is an enlarged cross-sectional view showing the vicinity of the proximal end of the drug dispensing device. [Figure 9] Figure 5 is an enlarged cross-sectional view showing the vicinity of the tip of the drug dispensing device. [Figure 10] This is a perspective view of the needle cover and syringe unit that make up the drug administration device. [Figure 11] Figure 10 is a perspective view of the syringe unit's external appearance. [Figure 12] Figure 11 is an exploded perspective view of the syringe unit. [Figure 13] Figure 12 is an overall front view of the syringe unit. [Figure 14] Figure 13 is a plan view of the syringe holder as seen from the proximal end. [Figure 15]It is a plan view of the syringe holder shown in Fig. 13 as seen from the tip side. [Figure 16] It is an enlarged front view of the vicinity of the tip of the syringe holder shown in Fig. 13. [Figure 17] It is a cross-sectional view taken along line XVII-XVII of Fig. 16. [Figure 18] It is a cross-sectional view taken along line XVIII-XVIII of Fig. 17. [Figure 19] It is an enlarged perspective view showing the vicinity of the tip of the syringe unit according to the modified example. [Figure 20] It is a cross-sectional view taken along line XX-XX of Fig. 19. [Figure 21] Fig. 21 is a plan view of the needle hub as seen from the proximal end side. [Figure 22] It is a cross-sectional view taken along line XXII-XXII of Fig. 5. [Figure 23] It is a cross-sectional view taken along line XXIII-XXIII of Fig. 5. [Figure 24] It is an exploded perspective view of the drive unit in the liquid medicine administration device. [Figure 25] It is an exploded perspective view of the lock member and the lock body in the drive unit of Fig. 24. [Figure 26] It is a cross-sectional view of the liquid medicine administration system taken along line XXVI-XXVI of Fig. 1. [Figure 27] It is a cross-sectional view taken along line XXVII-XXVII of Fig. 26. [Figure 28] It is an overall cross-sectional view showing the state where the needle cover of the liquid medicine administration device of Fig. 5 is pressed against the skin and punctured. [Figure 29] It is an enlarged cross-sectional view showing the vicinity of the proximal end of the liquid medicine administration device shown in Fig. 28. [Figure 30] It is an overall cross-sectional view showing another cross-section of the liquid medicine administration device of Fig. 28. [Figure 31] It is an overall cross-sectional view showing the state where the connection between the syringe and the double-headed needle of the liquid medicine administration device is completed. [Figure 32] It is an enlarged cross-sectional view showing the vicinity of the tip of the liquid medicine administration device of Fig. 31. [Figure 33]This is an overall cross-sectional view showing the state after the gasket has moved within the barrel and the drug injection is complete. [Figure 34] This is an overall cross-sectional view showing the administration of a fixed amount of drug solution using a modified plunger. [Figure 35] This is an overall cross-sectional view showing the double-ended needle covered by the needle cover of the drug administration device. [Figure 36] Figure 36A is an enlarged cross-sectional view near the base end showing the movement of the locking member toward the tip when the drug administration device is separated from the skin after drug administration is complete, and Figure 36B is an enlarged cross-sectional view showing the state in which the locking member shown in Figure 36A has moved and the engaging arm has elastically deformed radially inward. [Figure 37] Figure 35 is an enlarged cross-sectional view showing the vicinity of the proximal end of the drug dispensing device. [Figure 38] Figure 37 is an overall cross-sectional view showing a different cross-section of the drug administration device. [Figure 39] This is an overall cross-sectional view of the drug administration system relating to the second configuration. [Figure 40] This is an enlarged cross-sectional view showing the vicinity of the tip of the drug dispensing device. [Figure 41] This is an enlarged cross-sectional view showing the completed puncture state, with the first needle of the drug injection device inserted and the first antibacterial cover folded. [Figure 42] This is an enlarged cross-sectional view showing the first and second antibacterial covers folded and the double-ended needle and syringe connected. [Figure 43] Figure 43A is a schematic diagram showing a first sterilization apparatus for sterilizing needle units using the first sterilization method, and Figure 43B is a schematic diagram showing a second sterilization apparatus for sterilizing syringes using the second sterilization method. [Figure 44] This is a perspective view of a drug dispensing device showing how to sterilize the drug dispensing system by dropping sterile water into the packaging container using a third sterilization method. [Figure 45] This is an enlarged cross-sectional view showing the vicinity of the tip of the drug administration system relating to the third configuration. [Figure 46] Figure 46A is a partial cross-sectional front view of the first antibacterial cover, and Figure 46B is a partial cross-sectional front view of the second antibacterial cover. [Figure 47] Figure 45 is an enlarged cross-sectional view showing the drug administration device in which the first antibacterial cover is folded and the first needle portion has been punctured. [Figure 48] Figure 47 is an enlarged cross-sectional view showing the drug administration device in which the second antibacterial cover is folded and the double-ended needle and syringe are connected, indicating the completed connection state. [Figure 49] This is an overall cross-sectional view of the drug administration system relating to the fourth component. [Figure 50] Figure 49 is a perspective view of the syringe holder in the drug administration device. [Figure 51] Figure 50 is an enlarged front view showing the vicinity of the tip of the syringe holder. [Figure 52] This is a cross-sectional view along the LII-LII line in Figure 51. [Figure 53] This is a cross-sectional view along the line LIII-LIII in Figure 52. [Figure 54] Figure 49 is a cross-sectional view along the LIV-LIV line. [Figure 55] Figures 55A to 55C are enlarged diagrams illustrating the process in which the first guide rib is inserted into the first guide groove and the syringe unit is decelerated by the reduction mechanism. [Figure 56] This is an overall cross-sectional view of the drug administration system relating to the fifth component. [Figure 57] Figure 56 is an overall cross-sectional view of the drug administration device shown. [Figure 58] Figure 57 is an enlarged front view of the vicinity of the tip of the syringe holder of the drug administration device. [Figure 59] Figure 57 is an enlarged cross-sectional view showing the vicinity of the tip of the drug dispensing device. [Figure 60] Figure 57 is an overall cross-sectional view showing the puncture state of the drug administration device. [Figure 61] Figure 60 is an enlarged cross-sectional view showing the vicinity of the needle hub of the drug injection device. [Figure 62] Figure 60 is an overall cross-sectional view showing the drug administration state using the drug administration device. [Figure 63] Figure 62 is an enlarged cross-sectional view showing the vicinity of the needle hub of the drug injection device. [Modes for carrying out the invention]

[0011] The drug administration system 10A will be described with reference to Figures 1 to 38. As shown in Figures 1 and 2, the drug administration system 10A comprises a drug administration device 12A and a packaging container 14 in which the drug administration device 12A is housed.

[0012] The drug administration device 12A is used, for example, to administer drug solution M subcutaneously (to the puncture target) to a patient who is the user. As shown in Figures 3 to 9, the drug administration device 12A includes a housing 16 formed in the shape of a hollow cylinder, a needle cover 18A movably housed inside the housing 16, a syringe unit 20A housed inside the housing 16, a needle unit 26A consisting of a double-ended needle 22 and a needle hub 24A, a guide mechanism 28 that guides the syringe unit 20A toward the tip, and a drive unit 34 having a locking mechanism 32 that prevents the plunger 30 from moving toward the tip in the initial state before the puncture operation is performed by the user.

[0013] The housing 16 is formed in a cylindrical shape from a resin material. When viewed from the axial direction, the cross-section of the housing 16 is elliptical (see Figure 3). The housing 16 has a cylindrical body 36 that extends along the axial direction (arrows A and B directions) and an end cap 38 that closes the base end of the cylindrical body 36.

[0014] The cylindrical body 36 has a predetermined length in the axial direction (arrows A and B). The tip and base of the cylindrical body 36 are open. The peripheral wall of the cylindrical body 36 is provided with an inspection window 40 and a hole 42. The inspection window 40 penetrates the peripheral wall of the cylindrical body 36, making the syringe 68 housed inside the cylindrical body 36 visible from the outside.

[0015] The holes 42 are located near the base end of the cylindrical body 36 (in the direction of arrow A), and are provided in pairs spaced apart along the peripheral wall of the cylindrical body 36, and penetrate to the interior of the cylindrical body 36.

[0016] As shown in Figures 3 to 5, the circumferential wall of the cylindrical body 36 is provided with first to third engagement holes 44a, 44b, and 44c. The first to third engagement holes 44a, 44b, and 44c are each positioned at an angle of approximately 90° in the circumferential direction with respect to the opening direction of the inspection window 40. The first to third engagement holes 44a, 44b, and 44c each penetrate the circumferential wall of the cylindrical body 36.

[0017] The pair of first engagement holes 44a are positioned towards the tip (in the direction of arrow B) from the inspection window 40 and are arranged symmetrically with respect to the axial center of the cylindrical body 36. The first engagement portion 46a of the needle hub 24A, which is housed inside the cylindrical body 36, engages with the first engagement holes 44a (see Figure 5).

[0018] The pair of second engagement holes 44b are positioned towards the base end (direction of arrow A) from the inspection window 40 and are arranged symmetrically with respect to the axial center of the cylindrical body 36. The second engagement portion 46b of the syringe holder 70A, which is housed inside the cylindrical body 36, can engage with the second engagement holes 44b (see Figure 5).

[0019] The pair of third engagement holes 44c are positioned further towards the base end (direction of arrow A) than the second engagement hole 44b, and are arranged symmetrically with respect to the axial center of the cylindrical body 36. The third engagement portion 46c of the end cap 38, which is attached to the base end of the cylindrical body 36, engages with the third engagement holes 44c (see Figure 5).

[0020] As shown in Figures 5 to 8, the end cap 38 has a lid portion 48 that closes the base end of the cylindrical body 36, a retaining portion 50 that extends from the outer edge of the lid portion 48 toward the tip (direction of arrow B), a retaining cylinder portion 52 that is positioned radially inward of the retaining portion 50 and protrudes from the lid portion 48 toward the tip, and a shaft portion 54 that extends from the center of the lid portion 48 toward the tip. The lid portion 48 is disc-shaped and closes the base end of the open cylindrical body 36.

[0021] As shown in Figure 6, the retaining cylinder portion 52 is cylindrical with an opening towards the tip, and has a plurality of engaging protrusions 56 projecting radially outward from its outer peripheral surface at the tip. The engaging protrusions 56 are spaced apart from each other along the circumferential direction of the outer peripheral surface of the retaining cylinder portion 52. The engaging protrusions 56 engage with the lock body 156, which will be described later.

[0022] The retaining portion 50 is formed in an annular shape and protrudes from the end face of the lid portion 48 toward the tip (direction of arrow B). The outer circumferential surface of the retaining portion 50 is provided with a pair of third engaging portions 46c that protrude radially outward. The third engaging portions 46c are projections that protrude from the outer circumferential surface.

[0023] The base end of the syringe unit 20A comes into contact with the tip of the retaining portion 50, thereby preventing the syringe unit 20A from moving in the direction of the base end (direction of arrow A).

[0024] The shaft portion 54 is axial in shape, protruding from the end face of the lid portion 48 toward the tip. The shaft portion 54 is positioned on the axis of the housing 16. The shaft portion 54 is housed inside the cylindrical body 36, the lock body 156 (described later), and the syringe unit 20A, and extends to near the axial center of the cylindrical body 36 (see Figure 5).

[0025] The shaft portion 54 is inserted through the injection spring (biasing member) 146 and plunger 30, which constitute the drive unit 34 described later.

[0026] When the end cap 38 is attached to the base end of the cylindrical body 36, the third engaging portion 46c engages with the third engaging hole 44c of the housing 16, fixing the end cap 38 to the housing 16, and the open base end is closed by the lid portion 48, and the shaft portion 54 is positioned on the axis of the cylindrical body 36.

[0027] As shown in Figures 5 and 9, the needle cover 18A is formed in a hollow cylindrical shape and is provided at the tip of the housing 16, with at least a portion of it provided inside the cylindrical body 36 of the housing 16. The needle cover 18A is movable in the axial direction relative to the housing 16. In the initial state before the puncture operation by the user shown in Figures 5, 7 and 9, the needle cover 18A covers at least the first needle portion 112 of the needle unit 26A, which will be described later.

[0028] As shown in Figures 4 and 5, the needle cover 18A comprises a cylindrical main body portion 58 provided at the tip, a cover portion 60 extending from the main body portion 58 toward the base end (direction of arrow A), and a pair of extension portions 62 extending from the base end of the cover portion 60.

[0029] The main body 58 has a tip opening 64 that penetrates axially at the center of its tip. As the needle cover 18A is pressed against the user's skin S during the puncture operation, the needle cover 18A moves relative to the housing 16 in the direction of the base end (direction of arrow A), and the first needle portion 112 of the needle unit 26A is inserted through the tip opening 64 and protrudes from the needle cover 18A in the direction of the tip (direction of arrow B).

[0030] As shown in Figures 4 and 10, the cover portion 60 has a pair of slits 66. The slits 66 extend from the base end to the tip of the cover portion 60 and are arranged symmetrically with respect to the axis of the needle cover 18A. The slits 66 open at the base end of the cover portion 60. As shown in Figure 10, when the syringe unit 20A is housed inside the needle cover 18A, the pair of holder protrusions 102 of the syringe holder 70A can be inserted into the slits 66, respectively.

[0031] The extension portion 62 extends from the base end of the cover portion 60 toward the base end (direction of arrow A) and is positioned approximately 90° away from the slit 66 along the circumferential direction of the needle cover 18A. When the needle cover 18A moves relative to the housing 16 toward the base end (direction of arrow A), the base end of the extension portion 62 abuts against the tip of the locking member 152 of the drive unit 34, which will be described later, and pushes the locking member 152 toward the base end.

[0032] As shown in Figures 11 and 12, the syringe unit 20A comprises a syringe 68 and a syringe holder 70A provided on the outer circumference of the syringe 68 to hold the syringe 68, and is housed inside the housing 16 and is movable along the tip direction (direction of arrow B) (see Figure 5).

[0033] As shown in Figures 5 and 7, the syringe 68 comprises a barrel 74 having a chamber 72 filled with a drug solution M, a gasket 76 that can slide liquid-tightly inside the barrel 74, and a cap 78 fitted to the tip of the barrel 74. The base end of the barrel 74 has a flange 80 that widens radially outward from the barrel 74.

[0034] The syringe 68 has a nozzle 82 (see Figure 9) positioned at the tip of a barrel 74 and having a smaller diameter than the barrel 74, and a cap 78 is fitted to the outer surface of the nozzle 82. As a result, the outer surface of the nozzle 82 is covered by the cap 78. A nozzle hole 84 opens at the tip of the nozzle 82.

[0035] As shown in Figure 9, the cap 78 is formed as a cylindrical shape that is smaller in diameter and shorter in the axial direction than the syringe 68. The cap 78 has a large diameter portion 86 located at its base and a small diameter portion 88 located at the tip of the large diameter portion 86 and smaller in diameter than the large diameter portion 86, and has a stepped portion 90 at the boundary between the large diameter portion 86 and the small diameter portion 88. The stepped portion 90 has a surface that extends radially perpendicular to the axis of the cap 78. Since the cap 78 is formed to be smaller in diameter and shorter in the axial direction than the barrel 74 of the syringe 68, for example, when the syringe 68 is sterilized by heat, the amount of deformation of the cap 78 due to the heat is smaller than the amount of deformation of the syringe 68.

[0036] The tip of the small-diameter portion 88 has a through-hole 92 through which the second needle portion 114 of the double-ended needle 22 can be inserted. The through-hole 92 is opposite and communicates with the nozzle hole 84 of the syringe 68. The tip of the through-hole 92 has a trapezoidal cross-section that widens towards the tip. A cover 94 is provided between the inner surface of the tip of the small-diameter portion 88 and the inner surface of the tip of the cap 78. The through-hole 92 and the nozzle hole 84 face each other via the cover 94. The cover 94 is a disc-shaped body made of an elastic material with a constant thickness. The cover 94 faces the through-hole 92 and is held between the inner surface of the tip of the small-diameter portion 88 and the inner surface of the tip of the cap 78.

[0037] As shown in Figures 11 and 12, the syringe holder 70A has a cylindrical holder body 96, a flange housing 98 formed at the base end of the holder body 96, and a holder tip cylindrical portion 100 extending from the tip of the holder body 96 in the direction of the tip (arrow B direction). The syringe holder 70A is provided inside the housing 16 so as to be movable in the direction of the tip (arrow B direction).

[0038] The holder body 96 extends axially, and the barrel 74 is housed inside the holder body 96. Since the syringe 68 may deform and bend due to heat applied during autoclave sterilization, etc., there is a clearance between the holder body 96 and the barrel 74 that allows for such deformation (see Figure 5). The outer circumferential surface of the holder body 96 has a pair of holder protrusions 102. The holder protrusions 102 project radially outward from the outer circumferential surface of the holder body 96 and extend axially. The pair of holder protrusions 102 are arranged symmetrically with respect to the axis of the syringe holder 70A.

[0039] When the syringe unit 20A is housed inside the needle cover 18A, the holder protrusions 102 of the syringe holder 70A are inserted into the slits 66 (see Figure 10).

[0040] The holder projection 102 is provided with a second engaging portion (engaging portion) 46b. The second engaging portion 46b protrudes in a direction perpendicular to the extending direction of the holder projection 102. When the syringe holder 70A is housed inside the housing 16, the second engaging portion 46b engages with the second engaging hole 44b of the housing 16. In the initial state before the user performs a puncture operation, the syringe unit 20A, including the syringe holder 70A, is held in the housing 16 by the engagement of the second engaging portion 46b with the second engaging hole 44b (see Figures 5 and 6).

[0041] As shown in Figures 11 to 14, the flange housing portion 98 is formed in a substantially elliptical shape corresponding to the flange 80 of the syringe 68, and is a recessed shape that is lower than the base end of the syringe holder 70A. The flange 80 of the syringe 68 is housed inside the flange housing portion 98. By housing the flange 80 of the syringe 68 in the flange housing portion 98, the syringe 68 is positioned and held toward the tip relative to the syringe holder 70A.

[0042] The flange housing portion 98 has a pair of curved portions 104 that protrude in the direction of the base end on its outer side. The curved portions 104 constitute the outer edge of the flange housing portion 98 and have a curved shape that is convex radially outward. A base end support guide 140 of the guide mechanism 28, which will be described later, is arranged on the outer circumferential surface of the curved portions 104. The base end of the holder projection 102 extends to the base end of the curved portion 104 and constitutes part of the base end support guide 140.

[0043] As shown in Figures 11 to 13, the holder tip section 100 is cylindrical with a smaller diameter than the holder body section 96. The nozzle 82 and cap 78 of the syringe 68 are housed inside the holder tip section 100. The holder tip section 100 is positioned to surround the nozzle 82 and cap 78 of the syringe 68 (see Figure 9). The holder tip section 100 is inserted into the guide section 118 of the needle hub 24A.

[0044] As shown in Figures 13, 15, and 16, the holder tip cylindrical portion 100 includes a holding portion 106 that elastically biases the cap 78 radially inward, and a tip slide guide 130 (described later) that guides the needle hub 24A when it is inserted into the guide cylindrical portion 118.

[0045] The holding portion 106 elastically biases the tip of the syringe 68 radially inward via the cap 78. The holding portion 106 has a plurality of flexible arms 108 that press radially inward at multiple points in the circumferential direction against the outer surface of the cap 78. The plurality of flexible arms 108 are arranged in an opening 110 that opens at the base end of the holder tip cylindrical portion 100, and protrude from the tip of the holder body portion 96 toward the tip (direction of arrow B) at the opening 110. The inner circumferential surface (inner radial end) of the flexible arm 108 abuts against the outer circumferential surface of the small diameter portion 88 of the cap 78 (see Figures 17 and 18).

[0046] Multiple flexible arms 108 are arranged at equal intervals from one another along the circumferential direction of the syringe holder 70A. The multiple flexible arms 108 press the cap 78 of the syringe 68 radially inward at multiple points along the circumferential direction, thereby coaxially holding the nozzle 82 (cap 78), which is the tip of the syringe 68, with respect to the holder tip cylinder 100, which is the tip of the syringe holder 70A. It is preferable that there be at least three or more flexible arms 108.

[0047] Because the cap 78, which is pressed by the flexible arm 108, has a smaller diameter and is shorter in the axial direction compared to the barrel 74, for example, when autoclave sterilization is performed and heat is applied to the syringe 68, the amount of deformation of the cap 78 due to the heat is smaller than the amount of deformation of the barrel 74. Therefore, by holding the cap 78 with the flexible arm 108, the tip of the syringe 68 can be held coaxially with respect to the syringe holder 70A with higher precision via the cap 78.

[0048] As shown in Figure 18, the multiple flexible arms 108 press radially against the small diameter portion 88 of the cap 78.

[0049] For example, a syringe holder 70a having a retaining portion 106a according to the modified example shown in Figures 19 and 20 may be used. The retaining portion 106a of the syringe holder 70a has a plurality of flexible arms 108a that press the outer circumferential surface of the cap 78 radially inward at multiple locations in the circumferential direction.

[0050] Multiple flexible arms 108a are positioned in the opening 110 of the holder tip cylindrical portion 100, protruding from the opening tip of the opening 110 toward the base end (direction of arrow A), and the inner circumferential surface (inner radial end) of the flexible arms 108a abuts against the outer circumferential surface of the small diameter portion 88 of the cap 78.

[0051] Multiple flexible arms 108a are arranged at equal intervals from each other along the circumferential direction of the syringe holder 70a. The multiple flexible arms 108a press the cap 78 of the syringe 68 radially inward, thereby holding the nozzle 82 (cap 78), which is the tip of the syringe 68, coaxially with the holder tip cylinder portion 100, which is the tip of the syringe holder 70a. The multiple flexible arms 108a press the small diameter portion 88 of the cap 78 and engage with the tip side of the stepped portion 90 of the cap 78.

[0052] The contact area between the inner surface of the flexible arm 108a and the outer surface of the cap 78 is larger than the contact area between the flexible arm 108 of the syringe holder 70A and the cap 78. Therefore, by making multiple flexible arms 108a contact the outer surface of the cap 78 over a larger area and pressing them radially inward, the cap 78 (nozzle 82) can be held coaxially at the tip of the syringe holder 70a.

[0053] As shown in Figures 5 and 9, the needle unit 26A comprises a double-ended needle 22 having first and second needle portions 112 and 114, and a needle hub 24A having a support portion 124 that supports the double-ended needle 22, and is positioned inside the housing 16 toward the tip of the syringe unit 20A (direction of arrow B).

[0054] The double-ended needle 22 has a first needle portion 112 that protrudes from the support portion 124 toward the tip to puncture the skin S, and a second needle portion 114 that protrudes from the support portion 124 toward the proximal end, and is fixed to the support portion 124 of the needle hub 24A by adhesive or the like. The lumen 112a of the first needle portion 112 and the lumen 114a of the second needle portion 114 are in communication with each other.

[0055] The needle hub 24A comprises a hub body 116 held by the housing 16 and a guide cylinder portion 118 provided at the tip of the hub body 116, and the tip of the syringe unit 20A can be inserted into the inside of the needle hub 24A from the base end toward the tip.

[0056] The hub body 116 is formed in a cylindrical shape with an open base end, and the outer circumferential surface of the hub body 116 is provided with a pair of elastically tiltable arm portions 120. The tips of the arm portions 120 are fixed ends connected to the outer circumferential surface of the hub body 116, and they extend from the tips toward the base end. The base end of the movable arm portion 120 is provided with a first engaging portion 46a that protrudes outward. The needle hub 24A is housed inside the housing 16 and the first engaging portion 46a engages with the first engaging hole 44a, thereby holding the needle hub 24A at the tip of the cylindrical portion in the housing 16 (see Figure 9).

[0057] A cover spring 122 is positioned between the hub body 116 and the needle cover 18A. The cover spring 122 is an elastic member made of a coil spring. The base end of the cover spring 122 engages with the tip of the hub body 116. The tip of the cover spring 122 engages with the inner surface of the tip of the main body portion 58 of the needle cover 18A. The elastic force of the cover spring 122 biases the needle cover 18A to move relative to the housing 16 and the needle hub 24A in the direction of the tip (direction of arrow B).

[0058] The guide tube portion 118 is a bottomed cylindrical shape with a support portion 124 at its tip, surrounding the second needle portion 114, and allowing the holder tip tube portion 100 of the syringe holder 70A to be inserted into it. The tip of the guide tube portion 118 is equipped with a support portion 124 that supports the double-ended needle 22. The support portion 124 is perpendicular to the axial direction of the needle hub 24A, and the double-ended needle 22 is supported at the center of the support portion 124 by adhesive or the like. The first needle portion 112 is positioned on the outside (towards the tip) of the guide tube portion 118. That is, the first needle portion 112 and the second needle portion 114 of the double-ended needle 22 protrude in opposite directions with the support portion 124 in between.

[0059] As the syringe unit 20A moves toward the tip, the holder tip cylinder portion 100 is inserted into the guide cylinder portion 118 and the second needle portion 114 punctures the lid 94, after which the tip of the cap 78 held by the holder tip cylinder portion 100 comes into contact with the support portion 124. This locks the syringe unit 20A in place and stops its movement toward the tip (see Figures 31 and 32). The support portion 124 of the guide cylinder portion 118 functions as a stopper that can prevent the syringe unit 20A from moving toward the tip after the second needle portion 114 is connected to the syringe 68.

[0060] As shown in Figure 21, the inner circumferential surface of the guide cylinder portion 118 is provided with the tip support guide 138 of the guide mechanism 28, which will be described later.

[0061] As shown in Figure 5, the guide mechanism 28 is interposed between the housing 16 and the syringe unit 20A. The guide mechanism 28 has a guide rib that extends along the axial direction of the housing 16 and a guide groove that extends along the axial direction and engages with the guide rib. Specifically, the guide mechanism 28 includes a first guide portion 126 provided on the outer circumferential surface of the syringe holder 70A and extending along the axial direction, and a second guide portion 128 formed on the inner circumferential surface of the housing 16 and the needle hub 24A held by the housing 16, which extends along the axial direction and engages with the first guide portion 126. Multiple first guide portions 126 are provided along the circumferential direction of the syringe holder 70A. Multiple second guide portions 128 are provided along the circumferential direction of the housing 16 and the needle hub 24A.

[0062] As shown in Figure 11, the first guide section 126 is provided in multiple locations along the circumferential direction of the syringe holder 70A and includes a tip slide guide 130 (see Figure 22) provided at the tip of the syringe holder 70A and a base slide guide 132 (see Figure 23) provided at the base end of the syringe holder 70A.

[0063] As shown in Figure 22, the tip slide guide 130 consists of a plurality of first guide ribs 134 that protrude radially outward from the outer circumferential surface of the holder tip cylindrical portion 100 of the syringe holder 70A. Four first guide ribs 134 are provided at equal intervals along the circumferential direction of the holder tip cylindrical portion 100. When viewed from the axial direction of the syringe holder 70A, the cross-sectional shape of the first guide ribs 134 is triangular, tapering radially outward.

[0064] As shown in Figure 23, the base slide guide 132 consists of a plurality of second guide ribs 136 that project radially outward from the outer circumferential surface of the curved portion 104 of the syringe holder 70A. Three second guide ribs 136 are provided on each of the pair of curved portions 104, spaced apart from one another along the circumferential direction. There are a total of six second guide ribs 136. When viewed from the axial direction of the syringe holder 70A, the cross-sectional shape of the second guide ribs 136 is approximately rectangular.

[0065] As shown in Figure 22, the second guide portion 128 has a tip support guide 138 provided on the guide cylinder portion 118 of the needle hub 24A that supports the tip slide guide 130.

[0066] The tip support guide 138 consists of a plurality of first guide grooves 142 recessed radially outward from the inner circumferential surface of the guide cylinder portion 118. Four first guide grooves 142 are provided at equal intervals along the circumferential direction of the guide cylinder portion 118. First guide ribs 134 can be inserted into the first guide grooves 142. That is, there are equal numbers of first guide grooves 142 and first guide ribs 134. When viewed from the axial direction of the needle hub 24A, the cross-sectional shape of the first guide grooves 142 is triangular, tapering radially outward.

[0067] When the first guide rib 134 is inserted into the first guide groove 142, there is a small clearance between the first guide groove 142 and the first guide rib 134. The clearance between the first guide rib 134 and the first guide groove 142 is the smallest clearance between the syringe holder 70A and the needle hub 24A (see Figure 22).

[0068] As the syringe unit 20A, including the syringe holder 70A, moves toward the tip along the housing 16, the first guide rib 134 is guided along the first guide groove 142, thereby guiding the tip of the syringe unit 20A toward the tip.

[0069] As shown in Figure 23, the second guide section 128 has a base support guide 140 provided on the housing 16 that supports the base slide guide 132. The base support guide 140 is a plurality of second guide grooves 144 recessed radially outward from the inner circumferential surface of the cylindrical portion of the housing 16. Six second guide grooves 144 are provided spaced apart from each other along the circumferential direction of the cylindrical body 36. Second guide ribs 136 can be inserted into the second guide grooves 144. That is, there are equal numbers of second guide grooves 144 and second guide ribs 136. When viewed from the axial direction of the housing 16, the cross-sectional shape of the second guide grooves 144 is substantially rectangular.

[0070] When the syringe unit 20A, including the syringe holder 70A, moves toward the tip, the second guide rib 136 is guided along the second guide groove 144, thereby guiding the base end of the syringe unit 20A toward the tip. In other words, the first and second guide portions 126 and 128 enhance the straightness of the movement of the syringe unit 20A toward the tip.

[0071] As shown in Figures 6 and 24, the drive unit 34 includes a plunger 30 inserted into the syringe 68 and capable of pressing the gasket 76 toward the tip (direction of arrow B), an injection spring (biasing member) 146 that biases the plunger 30 toward the tip, and a locking mechanism 32 that prevents the plunger 30 from moving toward the tip in the initial state before the user performs a puncture operation. In the drug administration device 12A shown in Figure 6, the drive unit 34 is positioned near the base end of the housing 16.

[0072] As shown in Figure 6, the plunger 30 is a cylindrical body that is elongated in the axial direction (arrows A and B) and is arranged to be movable in the axial direction inside the housing 16. The plunger 30 is formed with a substantially constant diameter along the axial direction and is positioned toward the tip (arrow B) relative to the lid 48 of the end cap 38, with its tip side being inserted into the barrel 74 of the syringe 68. In the initial state shown in Figure 6, the tip of the plunger 30 is positioned a predetermined distance away from the gasket 76 toward the base (arrow A).

[0073] The shaft portion 54 of the end cap 38 and the injection spring 146 are inserted into the plunger 30. As shown in Figures 7 and 8, the outer circumferential surface of the plunger 30 has a pair of locking holes 150. The locking holes 150 are formed near the base end of the plunger 30 and penetrate radially inward from the outer circumferential surface of the plunger 30. The pair of locking holes 150 are arranged symmetrically with respect to the axis center of the plunger 30, and the locking claws 172 of the locking body 156 in the locking mechanism 32, which will be described later, engage with the locking holes 150 from the radially outward side.

[0074] The injection spring 146 is a coil spring and is longer than the axial length of the shaft portion 54. As shown in Figure 6, the injection spring 146 is interposed between the inner surface of the tip of the plunger 30 and the end face of the cover portion 48 of the end cap 38, and the elastic force of the injection spring 146 biases the plunger 30 toward the tip (direction of arrow B).

[0075] The locking mechanism 32 prevents the plunger 30 from moving toward the tip (direction of arrow B) in the initial state before the user performs a puncture operation. As shown in Figures 6 and 25, the locking mechanism 32 comprises a locking member 152 housed axially displaceable inside the housing 16, a locking sleeve spring (elastic member) 154 that biases the locking member 152 toward the tip, and a locking body 156 that engages with the plunger 30 in the initial state to prevent the plunger 30 from moving toward the tip.

[0076] The locking member 152 is formed in a cylindrical shape that surrounds the plunger 30. In the initial state shown in Figure 8, it is positioned on the outer circumference facing the locking hole 150 of the plunger 30. In the puncture state, it is pushed up by the needle cover 18A and moves towards the base end, positioned on the outer circumference of the retaining cylinder portion 52 of the end cap 38 (see Figure 29).

[0077] As shown in Figures 6 and 8, the locking member 152 comprises a cylindrical portion 158 and a flange portion 160 provided at the tip of the cylindrical portion 158. The base end of the cylindrical portion 158 has an inclined portion 162 that protrudes radially inward from the inner circumferential surface of the cylindrical portion 158. The tip surface of the inclined portion 162 is inclined toward the base end (direction of arrow A) from the inner circumferential surface of the cylindrical portion 158.

[0078] The flange portion 160 extends radially outward from the base end of the cylindrical portion 158. When the needle cover 18A moves relative to the housing 16 in the base direction during puncture as shown in Figures 28 and 29, the base end of the extension portion 62 of the needle cover 18A comes into contact with the flange portion 160, and the locking member 152 is pushed up in the base direction (direction of arrow A).

[0079] As shown in Figure 6, the outer circumferential surface of the locking member 152 has a pair of hook portions 164 extending from the flange portion 160 toward the base end. The hook portions 164 are formed in locking holes 166 that open on the outer circumferential surface of the locking member 152, and the tip of the hook portion 164 is fixed to the locking hole 166 in a cantilevered structure. The base end of the hook portion 164 is positioned inside the locking hole 166 and is capable of engaging with the body projection 177 of the lock body 156 that is inserted into the locking hole 166.

[0080] The lock sleeve spring 154 is a coil spring positioned on the outer circumference of the lock member 152 and is interposed between the lid portion 48 of the end cap 38 and the flange portion 160 of the lock member 152. The elastic force of the lock sleeve spring 154 biases the lock member 152 toward the tip (direction of arrow B).

[0081] As shown in Figures 5 to 8, the lock body 156 is positioned inside the housing 16 and inside the end cap 38. The lock body 156 is positioned near the base end of the plunger 30 and includes a body hole 168 into which the engaging projection 56 of the end cap 38 engages, a pair of radially elastically deformable engaging arms 170, a pair of lock claws 172 provided at the tips of the engaging arms 170, and a pair of body protrusions 177 projecting radially outward from the outer circumferential surface.

[0082] The body hole 168 opens onto the outer circumferential surface of the lock body 156 and penetrates radially inward. The retaining cylinder portion 52 of the end cap 38 is positioned inside the lock body 156, and the engaging projection 56 of the end cap 38 engages with the body hole 168 (see Figures 6 and 8). This fixes the lock body 156 to the end cap 38.

[0083] As shown in Figure 8, the pair of engaging arms 170 are positioned toward the tip of the body hole 168 (direction of arrow B). The base end of the engaging arm 170 is a fixed end, and the tip of the engaging arm 170 is an unfixed free end. The engaging arm 170 is elastically deformable with the base end as a fulcrum. The pair of engaging arms 170 are positioned symmetrically with respect to the axis of the lock body 156.

[0084] The locking claw 172 protrudes radially inward and radially outward from the tip of the engaging arm 170. The locking claw 172 comprises a first claw portion 174 that protrudes radially inward from the tip of the engaging arm 170, and a second claw portion 176 that protrudes radially outward from the tip.

[0085] The base end of the first claw portion 174 has an inclined surface that slopes radially inward toward the tip. In the initial state before the puncture operation by the user shown in Figure 8, the inclined surface of the first claw portion 174 engages with the lock hole 150 of the plunger 30. At this time, since the lock member 152 is positioned on the outer circumference of the engaging arm 170, deformation of the engaging arm 170 radially outward is prevented, and the engagement state between the lock claw 172 and the lock hole 150 is maintained.

[0086] In other words, in the locking mechanism 32, the first claw portion 174 of the locking claw 172 engages with the locking hole 150 of the plunger 30, thereby preventing the plunger 30 from moving in the direction of the tip (direction of arrow B), resulting in a locked state.

[0087] When the drug administration device 12A shown in Figures 28 and 29 is used for puncture, the locking member 152 moves relative to the housing 16 together with the needle cover 18A in the direction of the proximal end (direction of arrow A), causing the locking member 152 to be positioned further towards the proximal end than the engaging arm 170. As a result, the engaging arm 170 becomes deformable radially outward, and the locking claw 172 of the engaging arm 170 disengages from the locking hole 150 of the plunger 30, releasing the engagement between the engaging arm 170 and the plunger 30. This releases the locking mechanism 32's locking claw 172 from preventing the plunger 30 from moving.

[0088] The base end of the second claw portion 176 has an inclined surface that slopes radially outward toward the tip. When the locking member 152 moves toward the tip due to the elastic force of the lock sleeve spring 154, the locking member 152 and the engaging arm 170 come into contact, and the engaging arm 170 elastically deforms radially inward. This allows the locking member 152 to move toward the tip by overcoming the locking claw 172 of the engaging arm 170. In other words, the locking mechanism 32 enters an unlocked state that allows the plunger 30 to move toward the tip as the needle cover 18A moves toward the base end. The locking mechanism 32 enters an unlocked state when the locking member 152 moves toward the base end and reaches the unlocked position.

[0089] A pair of body protrusions 177 are formed on the outer circumferential surface of the tip of the lock body 156 and protrude radially outward from the outer circumferential surface. The body protrusions 177 are arranged symmetrically with respect to the axial center of the lock body 156. As shown in Figure 37, when the puncture operation is completed and the needle cover 18A and the lock member 152 move toward the tip, the body protrusions 177 are inserted into the locking holes 166 of the lock member 152 and engage with the base end of the hook portion 164. This prevents the axial movement of the lock member 152 from being prevented by the body protrusions 177.

[0090] The packaging container 14 shown in Figure 1 houses the drug dispensing device 12A in a sealed state. As shown in Figure 2, the packaging container 14 comprises a container body 178 in which the drug dispensing device 12A is housed, a sealing film 180, and an activation-preventing projection 182 that can prevent the activation of the drive unit 34 (see Figure 5, etc.) when the drug dispensing device 12A is housed inside. The container body 178 is formed in a substantially rectangular shape in plan view. Hereinafter, the long direction of the container body 178 will be referred to as the longitudinal direction, and the short direction of the container body 178 perpendicular to the longitudinal direction will be referred to as the width direction.

[0091] The container body 178 has a housing recess 184 in which the drug dispensing device 12A is housed, and an opening edge 188 surrounding an opening 186 for removing the drug dispensing device 12A. The container body 178 is formed from a relatively hard resin material. One end of the container body 178 in the longitudinal direction has a bulge 190 that bulges out in a semicircular shape in the longitudinal direction. The opening edge 188 is formed in a rectangular shape along the opening 186 of the housing recess 184 and is flange-like, extending outward from the opening 186.

[0092] The accommodating recess 184 is recessed downward from the opening edge 188 formed at the upper end of the container body 178, and is formed to accommodate the drug dispensing device 12A. The accommodating recess 184 has a bottom 184a formed in the opposite direction to the opening 186. The bottom 184a is flat along the longitudinal and width directions of the container body 178, and the drug dispensing device 12A is placed on a plurality of mounting parts 192 protruding from the bottom 184a.

[0093] Each mounting section 192 is formed in a shape corresponding to the external shape of the drug dispensing device 12A and is arranged spaced apart from each other along the longitudinal direction of the container body 178. The mounting sections 192 are formed to connect the side walls in the width direction of the container body 178.

[0094] When the drug dispensing device 12A is housed in the housing recess 184, the drug dispensing device 12A is held substantially horizontally by a plurality of mounting parts 192, and the base end of the drug dispensing device 12A is housed at one longitudinal end having a bulge 190, while the tip end of the drug dispensing device 12A is housed at the other longitudinal end. As shown in Figure 26, with the drug dispensing device 12A housed in the packaging container 14, the hole 42 of the housing 16 is located in the base direction (direction of arrow A) relative to the flange 160 of the locking member 152 in the drive unit 34.

[0095] The sealing film 180 is formed from a resin material such as polyethylene resin. The sealing film 180 is a flexible, thin sheet. In a plan view of the drug administration system 10A, the sealing film 180 is rectangular in shape and has approximately the same dimensions as the container body 178.

[0096] The sealing film 180 is positioned to cover the opening edge 188 of the container body 178, and the outer edge of the sealing film 180 is overlapped with the opening edge 188 and heated. This causes the outer edge of the sealing film 180 and the opening edge 188 of the container body 178 to be joined (fused). The drug dispensing device 12A is then sealed inside the container body 178 (in the housing recess 184) by the container body 178 and the sealing film 180 (see Figures 1 and 26).

[0097] The sealing film 180 is provided with a gripping portion 194 that extends in the longitudinal direction at one longitudinal end. When the sealing film 180 is fused to the container body 178, the gripping portion 194 protrudes outward (in the longitudinal direction) from the container body 178.

[0098] When the user removes the drug dispensing device 12A from the packaging container 14, the user grasps the gripping portion 194 and pulls the sealing film 180 upward relative to the container body 178, peeling the sealing film 180 from the opening edge 188 of the container body 178 and opening the container body 178.

[0099] As shown in Figure 2, the activation-preventing projection 182 is integrally provided with the mounting portion 192 located at the longest end in the longitudinal direction. The activation-preventing projection 182 is provided together with the mounting portion 192 at the bottom 184a of the housing recess 184, protruding from the bottom 184a toward the opening 186, and protruding further toward the opening 186 than the mounting portion 192. The activation-preventing projections 182 are arranged in pairs, spaced apart in the width direction of the container body 178.

[0100] As shown in Figure 27, when the drug dispensing device 12A is housed in the housing recess 184 and placed on the mounting section 192, the end of the activation blocking projection 182 is inserted into the housing 16 through the hole 42 of the housing 16.

[0101] As shown in Figure 26, when the drug dispensing device 12A is housed in the packaging container 14, the drug dispensing device 12A is in its initial state before the puncture operation. In the initial state of the drug dispensing device 12A, the activation-preventing projection 182 is positioned in the direction of the base end (arrow A direction) relative to the flange portion 160 of the locking member 152 of the drive unit 34. In other words, the activation-preventing projection 182 is positioned between the initial position where the locking member 152 is located towards the tip end and the unlocked position where the needle cover 18A moves relative to the housing 16 in the direction of the base end, causing the locking member 152 to move in the direction of the base end.

[0102] When the drug dispensing device 12A is housed in the packaging container 14, the activation-preventing projection 182 is inserted into the housing 16 through the hole 42, thereby preventing the locking member 152 from moving to the unlocked position. That is, when the drug dispensing device 12A is housed in the packaging container 14, the activation-preventing projection 182 restricts the movement of the locking member 152 toward its base end, thereby preventing the activation of the drive unit 34. When the drug dispensing device 12A is removed from the packaging container 14, the activation-preventing projection 182 is removed from the housing 16, thereby releasing the activation prevention for the drive unit 34.

[0103] Next, we will explain the case in which the drug administration device 12A is removed from the packaging container 14 and the puncture procedure is performed in the drug administration system 10A.

[0104] As described above, when the drug dispensing device 12A is housed in the packaging container 14, the activation-preventing projection 182 is inserted into the housing 16 through the hole 42 and is positioned further towards the base end than the flange 160 of the locking member 152. Therefore, the movement of the locking member 152 in the base end direction is restricted.

[0105] Therefore, in the case of an unopened drug dispensing system 10A, if the drug dispensing system 10A is accidentally dropped and an external force is applied, the activation-preventing projection 182 prevents the locking member 152 from moving to the unlocked position, and the activation of the drive unit 34 that occurs when the locking member 152 moves toward the base end is prevented.

[0106] In the drug administration system 10A shown in Figure 1, the user grasps the gripping portion 194 of the sealing film 180 and peels the sealing film 180 upward from the container body 178 to open the container body 178.

[0107] The user inserts their finger into the bulge 190 through the opening 186 of the opened container body 178 and removes the drug dispensing device 12A from the base end through the opening 186 to the outside of the packaging container 14 (see Figure 2). At this time, the activation blocking projection 182 is removed from the hole 42 of the housing 16, and the activation blocking of the drive unit 34 by the activation blocking projection 182 is released. In other words, the removal of the activation blocking projection 182 transitions the drive unit 34 from an activation-blocked state to an activation-released state. Since the activation blocking projection 182 is provided at the bottom 184a of the housing recess 184 and protrudes toward the opening 186, the activation blocking projection 182 can be easily and reliably removed from inside the housing 16 by moving the drug dispensing device 12A toward the opening 186 and removing it to the outside.

[0108] The drug dispensing device 12A, removed from the packaging container 14, is in its initial state, as shown in Figures 5 and 7, before puncture. In the initial state of the drug dispensing device 12A, the locking claw 172 of the engaging arm 170 of the lock body 156 is inserted into the lock hole 150 of the plunger 30 from the radially outward direction, and the engaging arm 170 is prevented from tilting radially outward (elastic deformation) by the locking member 152, which is biased toward the tip by the lock sleeve spring 154. In other words, the engaging arm 170 cannot elastically deform radially outward. Therefore, it is in a locked state in which the movement of the plunger 30 toward the tip is prevented by the locking mechanism 32 of the drive unit 34.

[0109] The user grasps the housing 16 of the drug administration device 12A and presses the tip of the needle cover 18A protruding from the tip of the housing 16 against the desired puncture site on the skin S at approximately a right angle. By continuously pushing the housing 16 further toward the skin S side (tip side, in the direction of arrow B), the needle cover 18A is pressed against the skin S, as shown in Figures 28 and 30, and relative to the housing 16, the needle cover 18A moves toward the proximal end (in the direction of arrow A) against the elastic force of the cover spring 122.

[0110] As shown in Figures 28 and 30, as the needle cover 18A moves relative to the proximal end, the first needle portion 112 of the double-ended needle 22 protrudes from the tip opening 64 of the needle cover 18A toward the tip (in the direction of arrow B). This results in a puncture state where the first needle portion 112 of the double-ended needle 22 penetrates the skin S and is inserted to a predetermined depth.

[0111] As shown in Figures 28 and 29, as the needle cover 18A moves toward the base end (direction of arrow A), the base end of the extension 62 of the needle cover 18A comes into contact with the flange 160 of the locking member 152 and pushes it upward toward the base end (direction of arrow A). The locking member 152 moves toward the base end while the needle cover 18A compresses the lock sleeve spring 154. When the locking member 152 reaches the unlocked position where it is positioned toward the base end than the engaging arm 170 having the locking claw 172, the engaging arm 170 becomes elastically deformable outward.

[0112] The elastic force of the injection spring 146 biases the plunger 30 of the drive unit 34 toward the tip (direction of arrow B), causing the engaging arm 170 to tilt along the lock hole 150 and the lock claw 172 to move outward, thereby disengaging the lock claw 172 from the lock hole 150 (see Figure 29).

[0113] As a result, the locking mechanism 32, specifically the locking claw 172, releases the plunger 30, and the plunger 30 begins to move toward the tip (direction of arrow B) due to the elastic force of the injection spring 146. In other words, the needle cover 18A functions as an activation switch to activate the drive unit 34 (plunger 30), which was previously prevented from being activated in the initial state before the user performs a puncture operation.

[0114] When the plunger 30 begins to move toward the tip, the tip of the plunger 30 comes into contact with the base end of the gasket 76. Subsequently, the plunger 30 pushes the gasket 76 toward the tip, and the plunger 30 and the gasket 76 move together. At this time, the chamber 72, which is toward the tip of the gasket 76, is filled with the chemical solution M, and the tip hole (nozzle hole 84) of the barrel 74 is blocked by the lid 94, so the chemical solution M is not discharged from the barrel 74.

[0115] Therefore, the liquid medicine M filled in the barrel 74 prevents the gasket 76 from moving toward the tip, and the plunger 30 moves toward the tip, pushing the syringe unit 20A, including the syringe 68, toward the tip via the gasket 76. As a result, the second engaging portion 46b of the syringe holder 70A disengages from the second engaging hole 44b of the housing 16, and the holding state of the syringe holder 70A relative to the housing 16 is released (see Figure 31).

[0116] The syringe unit 20A, pushed by the plunger 30, begins to move toward the tip along the housing 16. At this time, the second guide rib 136 of the syringe holder 70A moves toward the tip along the second guide groove 144, thereby guiding the syringe unit 20A, including the syringe holder 70A, toward the tip (see Figure 23).

[0117] As the plunger 30 moves toward the tip, the syringe unit 20A moves toward the tip, and the holder tip cylindrical portion 100 of the syringe holder 70A is inserted into the guide cylindrical portion 118 of the needle unit 26A via the hub body 116. As shown in Figure 22, the multiple first guide ribs 134 provided on the holder tip cylindrical portion 100 are each inserted into the first guide grooves 142 of the guide cylindrical portion 118, thereby guiding the tip of the syringe unit 20A toward the tip along the needle hub 24A.

[0118] In other words, by providing a first guide portion 126 on the outer circumferential surface of the syringe holder 70A, and a second guide portion 128 on the inner circumferential surface of the needle hub 24A and the housing 16, and engaging the first guide portion 126 with the second guide portion 128, when the syringe unit 20A moves toward the tip along the housing 16, tilting of the syringe unit 20A relative to the housing 16 is suitably prevented, and the straightness of the syringe unit 20A toward the tip is improved.

[0119] As the syringe unit 20A moves further toward the tip, the tip of the syringe unit 20A approaches the second needle portion 114 of the double-ended needle 22, and the second needle portion 114 begins to penetrate the lid 94. As shown in Figures 31 and 32, the base end of the second needle portion 114 penetrates the lid 94 and is inserted into the barrel 74 through the nozzle hole 84. As a result, the chamber 72 of the syringe 68 and the double-ended needle 22 are connected via the second needle portion 114, and the chamber 72 and the user's subcutaneous tissue are connected through the lumens 112a and 114a of the double-ended needle 22.

[0120] After the second needle portion 114 of the double-ended needle 22 is connected to the tip of the syringe 68, the syringe unit 20A moves further toward the tip, causing the tip of the cap 78 held in the holder tip cylindrical portion 100 of the syringe holder 70A to come into contact with the support portion 124 of the needle hub 24A (see Figures 31 and 32). This prevents the syringe unit 20A from moving toward the tip, causing it to stop in a predetermined position, and the second needle portion 114 is inserted further into the barrel 74, completing the connection between the double-ended needle 22 and the syringe 68.

[0121] After the syringe unit 20A stops moving toward the tip, the plunger 30 continuously pushes the gasket 76 toward the tip, and the connection with the double-ended needle 22 releases the seal on the drug chamber 72, allowing the gasket 76, pushed by the tip of the plunger 30, to move toward the tip within the drug chamber 72. As the gasket 76 moves toward the tip along the barrel 74, pushed by the plunger 30, the gasket 76 pushes the drug solution M in the drug chamber 72 toward the tip. As a result, the drug solution M is discharged from the lumen 114a of the second needle portion 114 of the double-ended needle 22 through the lumen 112a of the first needle portion 112, and administration of the drug solution M subcutaneously to the user begins.

[0122] As shown in Figure 33, when the gasket 76, pushed by the plunger 30, reaches the tip of the drug chamber 72, the administration of all the drug solution M filled in the drug chamber 72 is completed.

[0123] For example, a modified plunger 30a as shown in Figure 34 may be used. The outer circumferential surface of the plunger 30 has a pair of protrusions 196 that project radially outward. The protrusions 196 are located near the base end of the plunger 30a and project in a direction perpendicular to the axial direction of the plunger 30a. The pair of protrusions 196 are arranged symmetrically with respect to the axial center of the plunger 30a.

[0124] The second needle portion 114 of the double-ended needle 22 is connected to the tip of the syringe 68, and when the plunger 30a pushes the gasket 76 toward the tip to administer the drug solution M, the movement of the gasket 76 causes the drug solution M in the drug chamber 72 to begin to be administered through the double-ended needle 22, and the plunger 30a moves so that the protrusion 196 comes into contact with the flange 80 of the syringe 68, stopping the plunger 30a's movement toward the tip.

[0125] As a result, as shown in Figure 34, the protrusion 196 stops the plunger 30a from moving toward the tip before the gasket 76 reaches the tip of the chamber 72, thereby allowing only a portion of the drug solution M filled in the chamber 72 to be administered. Therefore, it becomes possible to administer only a predetermined amount of drug solution M in the chamber 72.

[0126] After the administration of the drug solution M shown in Figure 33 is completed, the user releases the pressure on the drug solution administration device 12A against the skin S, causing the needle cover 18A to be biased toward the tip (direction of arrow B) by the elastic force of the cover spring 122. As shown in Figure 35, the tip of the needle cover 18A protrudes from the tip of the housing 16 and moves to a position where the tip of the needle cover 18A is toward the tip beyond the first needle portion 112 of the double-ended needle 22. As a result, the first needle portion 112 of the double-ended needle 22 is completely covered by the needle cover 18A. The first engaging portion 46a of the needle cover 18A engages with the first engaging hole 44a of the housing 16.

[0127] As the needle cover 18A moves toward the tip, the biasing force of the locking member 152 toward the base end by the needle cover 18A is released, and the locking member 152 moves toward the tip (direction of arrow B) by the elastic force of the lock sleeve spring 154. As shown in Figure 36A, as the locking member 152 moves toward the tip, the inclined portion 162 comes into contact with the second claw portion 176 of the locking claw 172. At this time, since the plunger 30 is moving toward the tip, the plunger 30 is not positioned inside the locking claw 172.

[0128] Therefore, as shown in Figure 36B, when the locking member 152 moves further toward the tip, the inclined portion 162 pushes the locking claw 172 inward, causing the engaging arm 170 to elastically deform inward, and the inclined portion 162 moves toward the tip, overcoming the locking claw 172. In other words, the locking member 152 becomes capable of moving toward the tip further than the locking body 156.

[0129] As shown in Figures 35 and 37, as the locking member 152 moves toward the tip of the locking body 156, the body projection 177 of the locking body 156 is inserted into the locking hole 166 of the locking member 152, and the body projection 177 is held by the base end of the hook portion 164 and the locking hole 166. As a result, the locking member 152 is held by the locking body 156, and its movement in the axial direction is prevented.

[0130] As shown in Figure 38, the extension 62 of the needle cover 18A is in contact with the tip (flange 160) of the locking member 152, thus preventing the needle cover 18A from moving in the direction of the proximal end (direction of arrow A). After puncture, since the movement of the needle cover 18A in the direction of the proximal end is prevented, even if a force is applied to the needle cover 18A in the direction of the proximal end, the first needle portion 112 of the double-ended needle 22 will not be exposed to the outside by the needle cover 18A, ensuring safety.

[0131] As described above, in the drug administration device 12A of the drug administration system 10A, when the tip of the needle cover 18A is pressed against the user's skin S and the needle cover 18A moves toward the proximal end, the locking mechanism 32 that prevents the plunger 30 from moving is released, and the elastic force of the injection spring 146 causes the plunger 30 to move toward the tip, pushing the gasket 76 of the syringe 68 toward the tip. As a result, the syringe 68 moves toward the tip together with the plunger 30, the second needle portion 114 of the double-ended needle 22 punctures the tip of the syringe 68, and the gasket 76 moves toward the tip along the chamber 72 of the barrel 74, so that the drug solution M is administered from the chamber 72 through the double-ended needle 22 that has been punctured under the user's skin.

[0132] As a result, the connection between the double-ended needle 22 and the syringe 68, and the administration of the drug solution M subcutaneously from the double-ended needle 22, can be performed automatically and continuously in conjunction with the user's puncture procedure. Therefore, the connection between the double-ended needle 22 and the syringe 68 can be easily and reliably performed without requiring the user to perform the connection operation.

[0133] When the syringe unit 20A moves toward the tip, the tip of the holder tip cylinder portion 100, which is the tip of the syringe holder 70A, comes into contact with the support portion 124 of the guide cylinder portion 118 of the needle hub 24A, thereby reliably stopping the movement of the syringe unit 20A toward the tip. As a result, after the syringe 68 is connected to the second needle portion 114 of the double-ended needle 22, the plunger 30 pushes the gasket 76 toward the tip relative to the barrel 74 of the syringe 68, and the administration of the drug solution M can be started by the gasket 76.

[0134] By positioning a syringe holder 70A around the outer circumference of the syringe 68 and holding the syringe 68 with the syringe holder 70A, when the syringe unit 20A moves toward the tip, the syringe holder 70A is guided toward the tip along the housing 16, thereby enabling the syringe 68 to move stably toward the tip.

[0135] In the initial state before the puncture operation is performed, the second engaging portion 46b of the syringe holder 70A is engaged with the second engaging hole 44b of the housing 16, and the syringe holder 70A is locked axially to the housing 16. Therefore, in the initial state in which the movement of the plunger 30 by the locking mechanism 32 is prevented, the syringe 68 can be held in a predetermined position relative to the housing 16.

[0136] The locking mechanism 32 comprises a locking member 152 displaceably provided inside the housing 16, a locking sleeve spring 154 that biases the locking member 152 toward the tip, and a locking body 156 that engages with the locking hole 150 of the plunger 30 in the initial state to prevent the plunger 30 from moving toward the tip. By biasing the locking member 152 toward the tip with the locking sleeve spring 154 and maintaining the engagement of the plunger 30 with the locking claw 172 of the locking body 156, the movement of the plunger 30 toward the tip can be prevented.

[0137] In the initial state before the puncture operation, the engaging arm 170 of the lock body 156 engages with the lock hole 150 of the plunger 30 from the radially outward direction, and the lock member 152 prevents the engaging arm 170 from tilting radially outward. Therefore, movement of the plunger 30 toward the tip is reliably prevented in the initial state, and by moving the lock member 152 toward the base end, the engagement of the engaging arm 170 with the plunger 30 is released, making it possible to move the plunger 30 toward the tip.

[0138] When the locking member 152 moves toward the tip due to the elastic force of the lock sleeve spring 154, the locking member 152 comes into contact with the engaging arm 170 of the lock body 156, causing the engaging arm 170 to elastically deform radially inward, thereby allowing the locking member 152 to move toward the tip. As a result, the movement of the locking member 152 toward the tip pushes the needle cover 18A toward the tip, thereby moving the needle cover 18A and covering the first needle portion 112 of the double-ended needle 22 with the needle cover 18A.

[0139] Next, the drug administration system 10B will be described with reference to Figures 39 to 44. Note that components identical to those in the drug administration system 10A are given the same reference numerals, and their detailed descriptions are omitted.

[0140] The drug administration system 10B shown in Figure 39 comprises a drug administration device 12B and a packaging container 14 having a sterilized internal space 14a in which the drug administration device 12B is housed.

[0141] As shown in Figures 39 and 40, the drug administration device 12B has a needle unit 26B, the needle unit 26B comprises a needle hub 24B, a first antibacterial cover 200 attached to the first needle portion 112 of a double-ended needle 22 supported by the needle hub 24B, and a second antibacterial cover 202 attached to the second needle portion 114 of the double-ended needle 22. In the double-ended needle 22, the antibacterial cover may be attached only to the first needle portion 112 that is inserted into the user's skin S.

[0142] As shown in Figure 40, the needle hub 24B includes a first annular projection 204 projecting from the center of the support portion 124 toward the tip (direction of arrow B) and a second annular projection 206 projecting from the center of the support portion 124 toward the base (direction of arrow A). The first annular projection 204 supports the first needle portion 112, and the second annular projection 206 supports the second needle portion 114.

[0143] The first and second antibacterial covers 200 and 202 are each formed in a cylindrical shape from an elastic material such as silicone rubber, butyl rubber, or elastomer, and are axially contractible. With the first and second antibacterial covers 200 and 202 attached to the double-ended needle 22, the double-ended needle 22 is irradiated with an electron beam or radiation together with the needle hub 24B, and the double-ended needle 22 is sterilized by either electron beam sterilization or radiation sterilization. The first and second antibacterial covers 200 and 202 are formed from a material that is permeable to electron beams or radiation.

[0144] The first antibacterial cover 200 comprises a first cover tip 208 that covers the tip of the first needle portion 112 in the initial state before the puncture shown in Figure 40, and a first cover base portion 210 connected to the support portion 124 of the needle hub 24B. The first cover tip 208 has a base 208a perpendicular to the extending direction of the first antibacterial cover 200. The first cover base portion 210 is open and engages with the outer circumference of the first annular projection 204 of the needle hub 24B, and is connected to and held by the first annular projection 204.

[0145] The base 208a is formed in a disc shape, and when the first bactericidal cover 200 is folded axially during puncture by the first needle portion 112 shown in Figure 41, the base 208a is housed and held in the receiving portion 218 formed on the inner surface of the tip of the main body portion 58 of the needle cover 18B. The receiving portion 218 is formed in the center of the inner surface of the tip of the needle cover 18B and is a cup shape that stands upright in an annular shape toward the proximal end. A tip opening 64 is open in the center of the receiving portion 218.

[0146] The second antibacterial cover 202 comprises a second cover tip 212 connected to the support portion 124 of the needle hub 24B, and a second cover base portion 214 that covers the base end (needle tip) of the second needle portion 114 in the initial state before puncture is performed as shown in Figure 40.

[0147] The tip portion 212 of the second cover is open and engages with the outer circumference of the second annular projection 206 of the needle hub 24B, connecting to and holding the second annular projection 206. In the initial state, the base portion 214 of the second cover is inserted into the insertion hole 92 of the cap 78.

[0148] Next, we will explain the case in which the drug administration system 10B, including the drug administration device 12B described above, is sterilized during manufacturing, with reference to Figures 43A to 44.

[0149] First, before assembling the drug administration device 12B, the needle unit 26B, including the double-ended needle 22, is subjected to a first sterilization method, which is electron beam sterilization or radiation sterilization (first sterilization step), as shown in Figure 43A.

[0150] As shown in Figure 43A, a needle unit 26B including a double-ended needle 22, in which a first antibacterial cover 200 is attached to the first needle portion 112 and a second antibacterial cover 202 is attached to the second needle portion 114, is placed into the first sterilization chamber 222 of the first sterilizer 220. In the first sterilization chamber 222, an electron beam or radiation is irradiated from the irradiation source 224 to the needle unit 26B for a predetermined time.

[0151] The electron beam or radiation penetrates the first and second sterile-shielding covers 200 and 202, thereby sterilizing the first and second needle portions 112 and 114 with electron beam or radiation. This ensures the sterility of the double-ended needle 22 covered by the first and second sterile-shielding covers 200 and 202.

[0152] Next, before assembling the drug administration device 12B, the syringe 68 is subjected to autoclave sterilization (high-pressure steam sterilization), which is the second sterilization method (second sterilization step).

[0153] As shown in Figure 43B, the liquid drug M is filled into the chamber 72 of the barrel 74, and the syringe 68 containing the liquid drug M is placed into the second sterilization chamber 228 of the second sterilizer 226. High-pressure steam is supplied into the second sterilization chamber 228 through the piping 230.

[0154] The syringe 68 is heated to a predetermined temperature in the second sterilization chamber 228 by high-pressure steam, and the syringe 68 is sterilized.

[0155] Finally, after assembling the drug dispensing device 12B, including the needle unit 26B sterilized by the first sterilization method and the syringe 68 sterilized by the second sterilization method, the drug dispensing device 12B is placed in the receiving recess 184 of the packaging container 14 as shown in Figure 44, and the internal space 14a of the packaging container 14 is sterilized by the third sterilization method (third sterilization step).

[0156] Specifically, with the drug dispensing device 12B shown in Figure 44 housed in the housing recess 184 of the packaging container 14, sterile water W is dripped from the supply nozzle 234 of the dripping device 232 into the housing recess 184 (internal space 14a) through the opening 186 of the container body 178. The sterile water W is hydrogen peroxide. After a predetermined amount of sterile water W has been dripped into the housing recess 184 from the supply nozzle 234, the container body 178 is sealed by fusing the sealing film 180 to the opening edge 188 of the container body 178.

[0157] By leaving the drug administration system 10B in an environment above room temperature, the sterile water W gradually vaporizes inside the packaging container 14, filling the internal space 14a of the packaging container 14 with sterile gas. The filling sterile gas effectively sterilizes both the inside and outside of the drug administration device 12B. This sterilizes the area between the lid 94 provided at the tip of the drug chamber 72 in the syringe 68 and the second needle portion 114 of the double-ended needle 22 that punctures the lid 94, ensuring sterility between the two.

[0158] Furthermore, the needle body of the drug administration device 12B to which the antibacterial cover is attached is not limited to a double-ended needle 22 having first and second needle portions 112 and 114. The needle body may also be a single-ended needle pre-attached to the tip of the syringe 68.

[0159] Next, the operation of the sterilized drug dispensing device 12B will be explained. Note that detailed explanations of operations identical to those of drug dispensing device 12A will be omitted.

[0160] Starting from the initial state before the puncture operation shown in Figure 40, when the user presses the tip of the needle cover 18B against the skin S and the needle cover 18B moves relative to the housing 16 in the proximal direction, as the needle cover 18B moves in the proximal direction, the base 208a of the first antibacterial cover 200 is inserted into the receiving portion 218 of the needle cover 18B, and then the tip portion 208 of the first cover is pushed up together with the needle cover 18B in the proximal direction (direction of arrow A) via the base 208a.

[0161] As shown in Figure 41, as the first cover tip portion 208, including the base 208a, moves toward the proximal end, the needle tip of the first needle portion 112 pierces the base 208a and protrudes toward the tip. As the needle cover 18B moves toward the proximal end, the first antibacterial cover 200 moves relative to the first cover tip portion 208 toward the first cover proximal end portion 210, and the first cover tip portion 208 folds and contracts axially toward the first cover proximal end portion 210. The first antibacterial cover 200 comes into contact with the receiving portion 218 of the needle cover 18B and folds so that it overlaps axially toward the proximal end.

[0162] Upon completion of puncture of the skin S by the first needle portion 112, the entire portion of the first antibacterial cover 200 between the base 208a and the proximal end portion 210 of the first cover is folded in the axial direction.

[0163] When the drive unit 34 is activated and the syringe unit 20A moves toward the tip together with the plunger 30, as the syringe unit 20A moves, the lid 94 comes into contact with the second cover base end 214 of the second antibacterial cover 202. Then, as the syringe unit 20A moves further toward the tip, the needle tip of the second needle portion 114 pierces and penetrates the second cover base end 214. By the needle tip of the second needle portion 114 piercing the lid 94, the tip of the syringe 68 and the second needle portion 114 are connected.

[0164] As shown in Figure 41, after the second needle portion 114 and the syringe 68 are connected, the syringe unit 20A moves further toward the tip, causing the end face of the lid 94 to push the base portion 214 of the second cover toward the tip, and the second antibacterial cover 202 moves relative to the base portion 214 toward the tip portion 212, causing the base portion 214 of the second cover to axially fold and contract toward the tip portion 212 (see Figure 42).

[0165] The second antibacterial cover 202 comes into contact with the base end of the second annular projection 206 and folds so that it overlaps axially toward the tip.

[0166] When the tip of the syringe unit 20A contacts the support portion 124 of the needle hub 24B and the connection between the double-ended needle 22 and the syringe 68 is completed, the portion of the second antibacterial cover 202 between the second cover tip portion 212 and the second cover base portion 214 is folded in the axial direction.

[0167] As described above, in the drug administration system 10B, the first needle portion 112 and the second needle portion 114 of the double-ended needle 22 are covered by the first antibacterial cover 200 and the second antibacterial cover 202, respectively, so the double-ended needle 22 can be sterilized before assembling the drug administration device 12B. On the other hand, the syringe 68 can be sterilized using a different sterilization method than that used for the double-ended needle 22 before assembling the drug administration device 12B. Therefore, suitable sterilization methods can be selected for the double-ended needle 22 and the syringe 68, respectively, thus avoiding a mismatch in sterilization methods for the double-ended needle 22 and the syringe 68.

[0168] Therefore, the functional degradation of the syringe 68 and double-ended needle 22 due to sterilization can be effectively suppressed. By sterilizing the packaging container 14 containing the drug administration device 12B using the third sterilization method with sterile water W, it is also possible to ensure sterility between the lid 94 of the syringe 68 and the double-ended needle 22.

[0169] Since the drug dispensing system 10B can be sterilized without using large-scale sterile environment equipment that requires considerable installation and maintenance costs, the overall sterility of the drug dispensing device 12B can be ensured inexpensively until immediately before use by the user.

[0170] By performing electron beam sterilization or radiation sterilization on the double-ended needle 22 (needle unit 26B) to which the first and second antibacterial covers 200 and 202 are attached, it is possible to avoid thermal effects on the support portion 124 of the needle hub 24B that supports the double-ended needle 22 by adhesive or the like.

[0171] By performing autoclave sterilization with high-pressure steam on the syringe 68 filled with the drug solution M in the drug chamber 72, the denaturation of the drug solution M can be avoided.

[0172] By dropping sterile water W into the container body 178 of the packaging container 14 and vaporizing the sterile water W in the internal space 14a of the container body 178, the entire inside of the container body 178 can be made to have a sterile atmosphere. Therefore, the overall sterility of the drug dispensing device 12B can be ensured until the sealing film 180 is peeled off from the container body 178 and the packaging container 14 is opened.

[0173] By using hydrogen peroxide solution instead of sterile water W, when the drug dispensing system 10B is left in an environment above room temperature, the hydrogen peroxide solution can be vaporized in the internal space 14a of the packaging container 14 and fill the packaging container 14. The filled hydrogen peroxide gas can effectively sterilize both the inside and outside of the drug dispensing device 12B.

[0174] Next, the drug administration system 10C will be described with reference to Figures 45 to 48. Note that components identical to those in drug administration systems 10A and 10B are given the same reference numerals, and their detailed descriptions are omitted.

[0175] The drug administration system 10C shown in Figure 45 comprises a drug administration device 12C and a packaging container 14 having a sterilized internal space 14a in which the drug administration device 12C is housed.

[0176] The needle unit 26C of the drug administration device 12C comprises a needle hub 24C, a first antibacterial cover 300 attached to the first needle portion 112 of a double-ended needle 22 supported by the needle hub 24C, and a second antibacterial cover 302 attached to the second needle portion 114 of the double-ended needle 22. The first and second antibacterial covers 300 and 302 are each formed in a cylindrical shape from an elastic material such as silicone rubber, butyl rubber, or elastomer. In the double-ended needle 22, the antibacterial cover may be attached only to the first needle portion 112 that is inserted into the user's skin S.

[0177] The needle hub 24C comprises a first housing portion 304 and a first annular projection 306 located on the tip side of the support portion 124, and a second housing portion 308 and a second annular projection 310 located on the base end side of the support portion 124.

[0178] The first housing section 304 is a recess capable of housing the first bellows section 316 of the first antibacterial cover 300 when the bellows section 316 is folded. The first housing section 304 opens toward the tip (direction of arrow B).

[0179] The first annular projection 306 surrounds the first needle portion 112 and protrudes from the support portion 124 toward the tip (direction of arrow B), and the first cover base end portion 314 of the first antibacterial cover 300, which will be described later, is held on its outer circumference. The first housing portion 304 is positioned inside the first annular projection 306.

[0180] The second housing section 308 is a recess capable of accommodating the second bellows section 324 of the second antibacterial cover 302 when the second bellows section 324 is folded. The second housing section 308 opens in the direction of the base end (direction of arrow A).

[0181] The second annular projection 310 surrounds the second needle portion 114 and protrudes from the support portion 124 toward the base end (direction of arrow A), and the second cover tip portion 320 of the second antibacterial cover 302, which will be described later, is held on its outer circumference. The second housing portion 308 is positioned inside the second annular projection 310.

[0182] The first antibacterial cover 300 comprises, in its initial state before the puncture operation shown in Figures 45 and 46A, a first cover tip 312 that covers the tip of the first needle portion 112, a first cover base portion 314 connected to the first annular projection 306 of the needle hub 24C, and a first bellows portion 316 provided between the first cover tip 312 and the first cover base portion 314.

[0183] The tip portion 312 of the first cover has a smaller diameter than the base portion 314 of the first cover. The base portion 314 of the first cover is open and engages with the outer circumference of the first annular projection 306 of the needle hub 24C and is held by the first annular projection 306.

[0184] As shown in Figure 46A, the first bellows section 316 is formed in a frustoconical shape and has a plurality of first folds 318 provided along the axial direction of the first antibacterial cover 300 and recessed in the radial direction perpendicular to the axial direction. The first bellows section 316 is foldable radially via the plurality of first folds 318.

[0185] The second antibacterial cover 302 comprises a second cover tip 320 connected to the second annular projection 310 of the needle hub 24C, a second cover base 322 that covers the base end (needle tip) of the second needle portion 114 in the initial state before the puncture operation shown in Figures 45 and 46B, and a second bellows portion 324 provided between the second cover tip 320 and the second cover base 322.

[0186] The tip portion 320 of the second cover is open and engages with the outer circumference of the second annular projection 310 of the needle hub 24C, and is held by the second annular projection 310. The base portion 322 of the second cover has a smaller diameter than the tip portion 320 of the second cover. In the initial state before puncture is performed, the base portion 322 of the second cover is inserted into and held in the insertion hole 92 of the cap 78.

[0187] As shown in Figure 46B, the second bellows section 324 is formed in a truncated cone shape and has a plurality of second folds 326 provided along the axial direction of the second antibacterial cover 302 and recessed in the radial direction perpendicular to the axial direction. The second bellows section 324 is foldable radially via the plurality of second folds 326.

[0188] Next, the operation of the drug administration device 12C of the drug administration system 10C will be explained. Note that detailed explanations of operations identical to those of drug administration devices 12A and 12B will be omitted.

[0189] Starting from the initial state before the puncture operation shown in Figure 45, when the user presses the tip of the needle cover 18B against the skin S and the needle cover 18B moves relative to the housing 16 in the proximal direction, as the needle cover 18B moves in the proximal direction, the first cover tip 312 of the first antibacterial cover 300 comes into contact with the receiving portion 218 of the needle cover 18B, and then the first cover tip 312 is pushed up in the proximal direction (direction of arrow A) together with the needle cover 18B.

[0190] As the needle cover 18B moves toward the base end, the first cover tip 312 moves relative to the first cover base end 314, as shown in Figure 47, and the first bellows section 316 is folded radially starting from the multiple first folds 318. At this time, because the first bellows section 316 is frustoconical in shape, the first antibacterial cover 300 can be folded smoothly, and the first cover tip 312 is folded so that it is radially inward relative to the first cover base end 314.

[0191] The first needle portion 112 protrudes outward from the first cover tip portion 312 when its needle tip penetrates the first cover tip portion 312, and also protrudes from the tip of the needle cover 18B through the tip opening 64 to penetrate the skin S.

[0192] As shown in Figure 47, as the needle cover 18B moves further toward the proximal end, the first bellows section 316 is folded radially inward on the radially inward side of the first cover proximal end 314, and the folded first bellows section 316 is housed in the first housing section 304 so that they overlap radially. The first antibacterial cover 300 contracts axially as the first bellows section 316 is folded radially, so that the first cover tip 312 approaches the first cover proximal end 314.

[0193] Once the puncture by the first needle portion 112 is complete, the first bellows portion 316 of the first antibacterial cover 300 is completely folded radially and stored in the first storage portion 304.

[0194] When the drive unit 34 is activated and the syringe unit 20A moves toward the tip together with the plunger 30, as the syringe unit 20A moves, the insertion hole 92 of the cap 78 comes into contact with the second cover base end 322 of the second antibacterial cover 302. Then, as the syringe unit 20A moves further toward the tip, the needle tip of the second needle portion 114 pierces and penetrates the second cover base end 322. The needle tip of the second needle portion 114 pierces the lid 94, connecting the tip of the syringe 68 with the second needle portion 114.

[0195] After the second needle portion 114 and the syringe 68 are connected, the syringe unit 20A moves further toward the tip, causing the cap 78 to push the base portion 322 of the second cover toward the tip, and the base portion 322 of the second cover moves relative to the tip portion 320 of the second cover. Consequently, the second bellows portion 324 of the second antibacterial cover 302 is folded radially, starting from the second fold 326. At this time, because the second bellows portion 324 is frustoconical in shape, the second antibacterial cover 302 can be folded smoothly, and the base portion 322 of the second cover is folded so that it is radially inward relative to the tip portion 320 of the second cover.

[0196] As the syringe unit 20A moves further toward the tip, the second bellows section 324 is folded radially inward on the radially inward side of the second cover tip 320, as shown in Figure 48, and the folded second bellows section 324 is housed in the second housing section 308 so that they overlap radially. The second antibacterial cover 302 contracts axially as the second bellows section 324 is folded radially, so that the base end 322 of the second cover approaches the second cover tip 320.

[0197] Once the connection between the second needle portion 114 of the double-ended needle 22 and the syringe 68 is complete, the second bellows portion 324 of the second antibacterial cover 302 is folded radially and housed in the second storage portion 308.

[0198] The drug delivery system 10C described above may be sterilized using the first to third sterilization methods performed on the drug delivery system 10B.

[0199] Furthermore, the needle body of the drug administration device 12C to which the antibacterial cover is attached is not limited to a double-ended needle 22 having first and second needle portions 112 and 114. The needle body may also be a single-ended needle pre-attached to the tip of the syringe 68.

[0200] Furthermore, the first antibacterial cover 300 may have a smaller diameter at its base portion 314 compared to its tip portion 312. The second antibacterial cover 302 may have a smaller diameter at its tip portion 320 compared to its base portion 322. In this case as well, when the first and second antibacterial covers 300 and 302 are folded in the axial direction, the first and second bellows portions 316 and 324 can be folded radially. At this time, the tip portion 312 of the first cover is housed radially outside the base portion 314 of the first cover, and the base portion 322 of the second cover is housed radially outside the tip portion 320 of the second cover.

[0201] As described above, the drug administration device 12C of the drug administration system 10C has first and second antibacterial covers 300 and 302 that are attached to the first and second needle portions 112 and 114 of the double-ended needle 22. The first antibacterial cover 300 includes a first cover base portion 314 connected to the needle hub 24C, a first cover tip portion 312 having a different diameter from the first cover base portion 314 and covering the tip of the first needle portion 112 in the initial state, and a first bellows portion 316 positioned between the first cover tip portion 312 and the first cover base portion 314. The second antibacterial cover 302 includes a second cover tip portion 320 connected to the needle hub 24C, a second cover base portion 322 having a different diameter from the second cover base portion 322 and covering the tip of the second needle portion 114 in the initial state, and a second bellows portion 324 positioned between the second cover tip portion 320 and the second cover base portion 322.

[0202] When the second needle portion 114 of the double-ended needle 22 punctures the user's skin S, the first cover tip portion 312 and the first cover base portion 314 of the first antibacterial cover 300 move relative to each other in the axial direction, causing the first bellows portion 316 to fold radially. Therefore, the radially foldable first and second antibacterial covers 300 and 302 can have a shorter axial dimension when folded compared to conventional antibacterial covers that fold in the axial direction.

[0203] As a result, both the first antibacterial cover 300 and the second antibacterial cover 302 that cover the double-ended needle 22 can be folded radially, thereby effectively reducing the axial dimensions of the drug administration device 12C having the double-ended needle 22.

[0204] By making the first bellows section 316 of the first antibacterial cover 300 and the second bellows section 324 of the second antibacterial cover 302 truncated cone shape, the first and second antibacterial covers 300 and 302 can be folded smoothly, thereby suppressing the increase in puncture resistance during puncture caused by providing the first and second antibacterial covers 300 and 302 to the double-ended needle 22.

[0205] When the first and second bellows sections 316 and 324 are folded, they can be housed in the first and second housing sections 304 and 308, respectively, which are provided inside the base end 314 of the first cover and the tip end 320 of the second cover. This allows the axial thickness near the support section 124 of the needle hub 24C where the first and second bellows sections 316 and 324 are folded to be suppressed. Consequently, the axial dimensions of the drug delivery device 12C, including the needle hub 24C, can be reduced.

[0206] In the first antibacterial cover 300, by making the tip portion 312 of the first cover smaller in diameter than the base portion 314 of the first cover, when the first antibacterial cover 300 is folded, the tip portion 312 of the first cover can be positioned radially inward of the base portion 314 of the first cover. Therefore, compared to the case where the base portion 314 of the first cover is smaller in diameter than the tip portion 312 of the first cover, the outer diameter of the first antibacterial cover 300 can be reduced, which can contribute to miniaturization of the drug dispensing device 12C.

[0207] By making the base end portion 322 of the second antibacterial cover 302 smaller in diameter than the tip portion 320 of the second cover, when the second antibacterial cover 302 is folded, the base end portion 322 of the second cover can be positioned radially inward of the tip portion 320 of the second cover. Therefore, compared to the case where the tip portion 320 of the second cover is smaller in diameter than the base end portion 322 of the second cover, the outer diameter of the second antibacterial cover 302 can be reduced, which can contribute to miniaturization of the drug dispensing device 12C.

[0208] By providing multiple radially recessed first folds 318 on the first bellows section 316, the first antibacterial cover 300 can be folded axially so that the first cover tip 312 and the first cover base 314 are positioned radially with respect to the multiple first folds 318. By providing multiple radially recessed second folds 326 on the second bellows section 324, the second antibacterial cover 302 can be folded axially so that the second cover tip 320 and the second cover base 322 are positioned radially with respect to the multiple second folds 326.

[0209] Next, the drug administration system 10D will be described with reference to Figures 49 to 55C. Note that components identical to those in drug administration systems 10A, 10B, and 10C are given the same reference numerals, and their detailed descriptions are omitted.

[0210] The drug administration system 10D shown in Figure 49 comprises a drug administration device 12D and a packaging container 14 in which the drug administration device 12D is housed.

[0211] The drug administration device 12D is equipped with a reduction mechanism 400 that reduces the speed at which the syringe unit 20D moves toward the tip during the puncture operation. The reduction mechanism 400 reduces the speed at which the syringe unit 20D moves toward the tip after the second needle portion 114 of the double-ended needle 22 has begun to penetrate the lid 94 of the syringe unit 20D, but before the connection between the tip of the syringe unit 20D and the second needle portion 114 is completed.

[0212] As shown in Figures 49 to 51, the reduction mechanism 400 has a reduction unit 402 positioned on the outer circumferential surface of the holder tip cylindrical portion 100 of the syringe holder 70D, and multiple reduction units 402 are provided along the circumferential direction of the holder tip cylindrical portion 100.

[0213] The reduction gear 402 is positioned at the base end of the holder tip cylindrical portion 100 and is an inclined projection 404 provided at the base end of the first guide rib 134.

[0214] As shown in Figures 51 to 53, the inclined projections 404 protrude outward from the first guide rib 134 in a direction perpendicular to the first guide rib 134, and are inclined such that the protrusion height from the first guide rib 134 increases toward the base end (direction of arrow A) (see Figure 53). When the syringe unit 20D moves toward the tip and the first guide rib 134 is inserted into the first guide groove 142, each inclined projection 404 fits into the inner surface 142a of the first guide groove 142, increasing the insertion length of the first guide rib 134 into the first guide groove 142. The inclined projections 404 gradually increase the sliding resistance between the syringe holder 70D and the needle hub 24A.

[0215] Alternatively, the inclined projection 404 of the reduction gear 402 may be provided on the inner surface 142a of the first guide groove 142 into which the first guide rib 134 is inserted, instead of the first guide rib 134. In this case, the inclined projection 404 is positioned at the tip of the first guide groove 142. That is, the reduction gear 402 only needs to be provided at least one of the base end of the outer circumferential surface of the holder tip cylindrical portion 100 of the syringe holder 70D, or at the tip of the inner circumferential surface of the guide cylindrical portion 118 of the needle hub 24A.

[0216] During the puncture procedure, as shown in Figure 55A, the syringe unit 20D moves toward the tip of the drug administration device 12D together with the plunger 30 due to the elastic force of the injection spring 146, and the tip of the first guide rib 134 of the syringe holder 70D begins to be inserted into the first guide groove 142 of the needle hub 24A from its base end. At this time, the inclined projection 404 is not yet inserted into the first guide groove 142.

[0217] As shown in Figure 55B, the syringe unit 20D moves toward the tip, and after the second needle portion 114 of the double-ended needle 22 begins to penetrate the tip (cap 94) of the syringe 68, the inclined projection 404 begins to contact the inner surface 142a of the first guide groove 142. As a result, the sliding resistance between the inclined projection 404 and the first guide groove 142 gradually increases.

[0218] Therefore, before the connection between the tip of the syringe unit 20D and the second needle portion 114 is completed, the deceleration unit 402 gradually reduces the movement speed of the syringe unit 20D toward the tip. The syringe unit 20D, whose movement speed has decreased, moves further toward the tip, and as shown in Figure 55C, the movement of the syringe unit 20D is stopped when the tip of the syringe unit 20D comes into contact with the support portion 124 of the needle hub 24A, which is a stopper, and the connection between the syringe unit 20D and the second needle portion 114 is completed.

[0219] In other words, the reduction mechanism 400 reduces the speed at which the syringe unit 20D moves toward the tip from the moment the second needle portion 114 begins to pierce the tip of the syringe 68 shown in Figure 55B until the connection between the second needle portion 114 and the tip of the syringe 68 is completed, as shown in Figure 55C.

[0220] The reduction gear 402 may be directly positioned on the outer circumferential surface of the holder tip cylindrical portion 100 on which the first guide rib 134 is provided, or it may be directly positioned on the inner circumferential surface of the guide cylindrical portion 118 on which the first guide groove 142 is provided. In other words, the reduction gear 402 only needs to be provided at least one of the base end of the outer circumferential surface of the holder tip cylindrical portion 100 and the tip end of the inner circumferential surface of the guide cylindrical portion 118.

[0221] As described above, during the puncture operation by the drug administration device 12D, when the syringe unit 20D moves toward the tip, the reduction mechanism 400 reduces the movement speed of the syringe unit 20D, thereby suppressing the impact received by the syringe unit 20D when its tip comes into contact with the needle hub 24A and stops. As a result, damage to the syringe unit 20D caused by impact can be prevented.

[0222] The reduction mechanism 400 can suitably reduce the movement speed of the syringe unit 20D with a simple configuration by increasing the sliding resistance of the syringe unit 20D as it moves toward the tip.

[0223] The reduction mechanism 400 has a reduction unit 402 provided on the outer circumferential surface of the holder tip cylindrical portion 100 of the syringe holder 70D. The reduction unit 402 protrudes from the outer circumferential surface of the holder tip cylindrical portion 100 and is formed to be able to contact the inner circumferential surface of the guide cylindrical portion 118 of the needle hub 24A into which the holder tip cylindrical portion 100 is inserted. As a result, when the syringe holder 70D moves toward the tip and the holder tip cylindrical portion 100 is inserted into the guide cylindrical portion 118 of the needle hub 24A, the syringe holder 70D and the needle hub 24A come into contact via the reduction unit 402, increasing the sliding resistance between the syringe holder 70D and the needle hub 24A. Consequently, it becomes possible to effectively reduce the speed at which the syringe unit 20D moves toward the tip.

[0224] By providing the reduction unit 402 in the holder tip cylinder portion 100 located at the tip of the syringe holder 70D, the movement speed of the syringe unit 20D, including the syringe holder 70D, can be reduced before the connection between the tip of the syringe 68 and the second needle portion 114 of the double-ended needle 22 is completed. Therefore, the increase in the time required to connect the syringe unit 20D and the double-ended needle 22 due to the provision of the reduction unit 402 can be minimized.

[0225] Because the clearance between the first guide rib 134 and the first guide groove 142 is smaller than the clearance between the syringe holder 70D and other components including the needle hub 24A, by placing the deceleration unit 402 on the first guide rib 134, the syringe holder 70D and the needle hub 24A can be brought into more reliable contact via the deceleration unit 402, thereby reducing the travel speed.

[0226] By making the deceleration unit 402 an inclined projection 404 provided on the first guide rib 134, as the syringe unit 20D moves toward the tip, the inclined projection 404 gradually slides against the inner surface 142a of the first guide groove 142 of the needle hub 24A, gradually increasing the sliding resistance between the syringe holder 70D and the needle hub 24A, thereby gradually decreasing the movement speed of the syringe unit 20D.

[0227] By providing multiple deceleration units 402 along the circumferential direction of the syringe holder 70D, it becomes possible to stably reduce the movement speed of the syringe 68 as it moves toward the tip.

[0228] Next, the drug administration system 10E will be described with reference to Figures 56 to 63. Note that components identical to those in drug administration systems 10A, 10B, 10C, and 10D are given the same reference numerals, and their detailed descriptions are omitted.

[0229] The drug administration system 10E shown in Figure 56 comprises a drug administration device 12E and a packaging container 14 in which the drug administration device 12E is housed.

[0230] The drug administration device 12E shown in Figure 57 is equipped with a vibration generating mechanism 500 that can impart vibration to the syringe unit 20E as the syringe unit 20E moves along the housing 16 toward the tip.

[0231] The vibration generating mechanism 500 includes a first vibration generating section 502 provided on the outer circumferential surface of the syringe unit 20E, and a second vibration generating section 504 formed on the needle hub 24E fixed inside the housing 16, which can come into contact with the first vibration generating section 502 when the syringe unit 20E moves toward the tip.

[0232] As shown in Figures 57 and 58, the first vibration generating unit 502 is positioned on the outer circumferential surface of the holder tip cylindrical portion 100, which is the tip of the syringe holder 70E. The first vibration generating unit 502 has a first projection 506 that protrudes radially outward from the outer circumferential surface of the holder tip cylindrical portion 100. In a drug administration device that does not have a syringe holder 70E but only a syringe 68, the first vibration generating unit 502 is provided on the outer circumferential surface of the syringe 68.

[0233] Multiple first projections 506 are provided along the direction of movement of the syringe unit 20E (directions of arrows A and B), and each first projection 506 is spaced apart in the direction of movement. The first projections 506 are arranged in pairs in the circumferential direction of the syringe unit 20E. The cross-sectional shape of the first projections 506 is a tapered triangular shape extending radially outward from the outer circumferential surface of the syringe 68. The first projections 506 may also be annular in shape extending along the circumferential direction of the syringe unit 20E.

[0234] As shown in Figure 57, the second vibration generating section 504 is provided on the inner circumferential surface of the base end of the guide cylinder portion 118 of the needle hub 24E and has a second projection 508 that protrudes radially inward from the inner circumferential surface. The second projection 508 is positioned opposite the first projection 506. The cross-sectional shape of the second projection 508 is a tapered triangular shape that extends radially inward from the inner circumferential surface of the needle hub 24E. When viewed from the axial direction of the syringe 68, the first projection 506 and the second projection 508 are arranged in an overlapping manner.

[0235] The second projection 508 may be a single projection or a plurality of projections arranged along the direction of movement of the syringe unit 20E. When multiple second projections 508 are arranged, each second projection 508 is spaced apart from each other in the axial direction of the needle hub 24E.

[0236] In the drug administration device 12E, during the puncture operation, the syringe unit 20E moves toward the tip together with the plunger 30 by the elastic force of the injection spring 146 from the initial state shown in Figure 57. Then, as shown in Figure 59, the tip of the holder tip cylinder portion 100 is inserted from the base end of the guide cylinder portion 118 of the needle hub 24E, and before the second needle portion 114 is connected to the tip (lid 94) of the syringe 68, the first projection 506, which is positioned furthest toward the tip, makes contact with the second projection 508. Vibration is generated by the contact between the first projection 506 and the second projection 508, and this vibration is applied to the vicinity of the nozzle 82, which is the tip of the syringe 68.

[0237] Since the drug dispensing device 12E is usually used with its tip pointed downward or diagonally downward, the vibrations applied to the vicinity of the nozzle 82 of the syringe 68 by the vibration generating mechanism 500 cause air bubbles (air) contained in the drug solution M in the chamber 72 of the barrel 74 to separate from the inner wall of the barrel 74, and the buoyancy of these air bubbles can move them toward the gasket 76 located above (see Figure 60).

[0238] As shown in Figure 61, as the syringe unit 20E moves toward the tip, the multiple first protrusions 506 come into continuous contact with the second protrusions 508, thereby applying multiple vibrations to the vicinity of the nozzle 82 of the syringe 68. This ensures that air bubbles contained in the drug solution M are separated from the inner wall of the barrel 74 and moved toward the gasket 76.

[0239] As shown in Figure 62, after the first projection 506, which is positioned furthest towards the base, passes the second projection 508 towards the tip, the tip of the syringe unit 20E comes into contact with the support portion 124 of the needle hub 24E, stopping the movement of the syringe unit 20E. The connection between the syringe unit 20E and the second needle portion 114 is completed (see Figure 63).

[0240] The elastic force of the injection spring 146 causes the plunger 30 to move further toward the tip, and the plunger 30 pushes the gasket 76 toward the tip, thereby administering the drug solution M subcutaneously to the user through the lumen 112a and 114a of the double-ended needle 22. At this time, as shown in Figures 62 and 63, the vibrations generated by the vibration generating mechanism 500 cause the air bubbles in the drug solution M to move toward the gasket 76 side (direction of arrow A), which is opposite to the double-ended needle 22, so that only the drug solution M without air bubbles can be administered through the double-ended needle 22.

[0241] Furthermore, when performing quantitative administration of the drug solution M using the plunger 30a having the protrusion 196 shown in Figure 34, the vibration generating mechanism 500 moves the air bubbles toward the base end, which allows for accurate administration of the drug solution M in the desired quantity, making it effective.

[0242] Furthermore, the needle of the drug administration device 12E having the vibration generating mechanism 500 is not limited to a double-ended needle 22 having first and second needle portions 112 and 114 that are connected to the tip as the syringe unit 20E moves. The needle may also be, for example, a single-ended needle pre-attached to the tip of the syringe 68.

[0243] As described above, the drug administration device 12E is equipped with a vibration generating mechanism 500 that can apply vibration to the syringe unit 20E when the syringe unit 20E moves toward the tip along the housing 16 during a puncture operation. By applying vibration to the syringe unit 20E with the vibration generating mechanism 500, air bubbles contained in the drug solution M filled in the barrel 74 of the syringe 68 are separated from the inner wall of the barrel 74 and moved toward the gasket 76 located above by the buoyancy of the air bubbles. As a result, when the drug solution M is administered subcutaneously to the user through the double-ended needle 22, the amount of air bubbles contained in the administered drug solution M is reduced, and it becomes possible to accurately administer a predetermined amount of drug solution M subcutaneously.

[0244] The vibration generating mechanism 500 includes a first vibration generating section 502 provided on the outer circumferential surface of the syringe unit 20E, and a second vibration generating section 504 provided on the inner circumferential surface of the needle hub 24E, which can contact the first vibration generating section 502 when the syringe unit 20E moves toward the tip. This allows for simple and reliable vibration generation by utilizing the tip-direction movement of the syringe unit 20E without the need for complex mechanisms such as actuators.

[0245] By providing multiple units of at least one of the first vibration generating unit 502 and the second vibration generating unit 504, vibrations are generated multiple times as the syringe unit 20E moves toward the tip, making it possible to more reliably move air bubbles contained in the drug solution M upward within the barrel 74.

[0246] The first vibration generating unit 502 has a first protrusion 506 that protrudes radially outward from the outer peripheral surface of the holder tip cylinder portion 100 of the syringe holder 70E, and the second vibration generating unit 504 has a second protrusion 508 that protrudes radially inward from the inner peripheral surface of the guide cylinder portion 118 of the needle hub 24E. Therefore, when the syringe unit 20E is moved toward the tip, intermittent vibrations can be imparted to the syringe unit 20E by bringing the first protrusion 506 into contact with the second protrusion 508. Accordingly, the bubbles contained in the chemical solution M and adhering to the inner wall of the barrel 74 can be reliably separated from the inner wall and moved upward.

[0247] By disposing the first vibration generating unit 502 at the holder tip cylinder portion 100 that is the tip of the syringe holder 70E, the bubbles in the chemical solution M that tend to accumulate at the tip in the barrel 74 of the syringe 68 can be reliably separated from the inner wall of the barrel 74 and moved from the tip of the syringe 68 toward the proximal end.

[0248] Summarizing the above embodiment, it is as follows.

[0249] The above embodiment includes a housing (16) formed in a hollow cylindrical shape, a syringe unit (20D) having a barrel (74) filled with a chemical solution (M) and being movable in the distal direction by the biasing force of a biasing member (146) within the housing, a double - ended needle (22) having a first needle portion (112) that protrudes in the distal direction and punctures a puncture target, and a second needle portion (114) that protrudes in the proximal direction toward the syringe unit, a needle hub (24A) that holds the double - ended needle, a stopper that completes the connection between the tip of the syringe unit and the second needle portion by stopping the syringe unit at a predetermined position after the syringe unit moves in the distal direction by the biasing force of the biasing member and the second needle portion begins to pierce the tip of the syringe unit, and a chemical solution administration device (12D) comprising When the syringe unit moves in the distal direction, after the second needle portion starts to pierce the distal end of the syringe unit, before the connection between the distal end of the syringe unit and the second needle portion is completed, a deceleration mechanism (400) is provided to reduce the moving speed of the syringe unit.

[0250] The deceleration mechanism reduces the moving speed by increasing the sliding resistance of the syringe unit during the movement of the syringe unit in the distal direction.

[0251] The needle hub has a guide cylinder portion (118) that surrounds the second needle portion and into which the distal end of the syringe unit is inserted. The guide cylinder portion is the stopper. The syringe unit has a syringe (68) having the barrel and a syringe holder (70D) that holds the syringe. The syringe holder has a holder distal end cylinder portion (100) that is inserted into the guide cylinder portion of the needle hub. The deceleration mechanism has a deceleration portion (402) provided on at least one of the outer peripheral surface of the holder distal end cylinder portion and the inner peripheral surface of the guide cylinder portion. The deceleration portion protrudes from at least one of the outer peripheral surface and the inner peripheral surface, and is formed to be able to contact the inner peripheral surface or the outer peripheral surface that is disposed opposite to the deceleration portion.

[0252] The deceleration portion is provided on at least one of the base end portion of the outer peripheral surface of the holder distal end cylinder portion and the tip end portion of the inner peripheral surface of the guide cylinder portion.

[0253] The inner peripheral surface of the guide cylinder portion has a guide groove (142) that is recessed radially outward and extends in the axial direction. The outer peripheral surface of the holder distal end cylinder portion has a guide rib (134) that protrudes radially outward and extends in the axial direction and is inserted into the guide groove. The deceleration portion is provided on at least one of the guide rib and the guide groove.

[0254] The reduction gear is an inclined projection (404) provided on the guide rib, The inclined projection is inclined such that its protrusion height from the guide rib increases toward the base end, and as the syringe unit moves toward the tip, the inclined projection engages with the guide groove, increasing the insertion length into the guide groove, thereby gradually increasing the sliding resistance between the syringe holder and the needle hub.

[0255] Multiple deceleration units are provided along the circumferential direction of the syringe holder.

[0256] Furthermore, the present invention is not limited to the embodiments described above, and various configurations can be taken without departing from the spirit of the invention. [Explanation of Symbols]

[0257] 10A~10E…Drug administration system 12A~12E…Drug administration device 16…Cabinet 20A, 20D, 20E... Syringe Unit 22... Double-ended needle; 24A~24C, 24E... Needle hub 68... Syringe 70A, 70a, 70D, 70E... Syringe holders 74...Barrel 112...First needle section 114...Second needle part 400...Deceleration mechanism

Claims

1. A housing formed in the shape of a hollow cylinder, A syringe unit having a barrel filled with a drug solution and movable towards the tip by the biasing force of a biasing member within the housing, A double-ended needle having a first needle portion that protrudes toward the tip and punctures the target to be punctured, and a second needle portion that protrudes toward the proximal end toward the syringe unit, A needle hub that holds the double-ended needle, A stopper that, after the syringe unit moves toward the tip due to the biasing force of the biasing member and the second needle portion begins to penetrate the tip of the syringe unit, stops the syringe unit at a predetermined position to complete the connection between the tip of the syringe unit and the second needle portion, A drug solution dispensing device equipped with, When the syringe unit moves toward the tip, after the second needle portion begins to penetrate the tip of the syringe unit, but before the connection between the tip of the syringe unit and the second needle portion is completed, a reduction mechanism is provided to reduce the movement speed of the syringe unit. The reduction mechanism reduces the moving speed by increasing the sliding resistance of the syringe unit as the syringe unit moves toward the tip. The needle hub has a guide tube portion that surrounds the second needle portion and into which the tip of the syringe unit is inserted. The guide cylinder portion is the stopper, The syringe unit comprises a syringe having the barrel and a syringe holder for holding the syringe. The syringe holder has a holder tip tube portion that is inserted into the guide tube portion of the needle hub, The reduction mechanism has a reduction section provided on the outer circumferential surface of the holder tip cylindrical portion, The drug dispensing device is such that the reduction gear protrudes from the outer circumferential surface and is formed to be able to contact the inner circumferential surface of the guide cylinder portion which is positioned opposite the reduction gear.

2. In the drug solution administration device according to claim 1, The reduction unit is a drug dispensing device provided at the base end of the outer circumferential surface of the holder tip cylindrical portion.

3. In the drug solution dispensing device according to claim 1 or 2, The inner circumferential surface of the guide cylinder portion is provided with a guide groove that is recessed radially outward and extends axially. The outer circumferential surface of the holder tip cylindrical portion is provided with guide ribs that protrude radially outward, extend axially, and are inserted into the guide groove. The reduction gear is a drug dispensing device provided on the guide rib.

4. In the drug administration device according to claim 3, The reduction gear is an inclined projection provided on the guide rib, A drug dispensing device wherein the inclined projection is inclined such that its protrusion height from the guide rib increases toward the base end, and as the syringe unit moves toward the tip, the inclined projection engages with the guide groove, increasing the insertion length into the guide groove, thereby gradually increasing the sliding resistance between the syringe holder and the needle hub.

5. In a drug solution administration device according to any one of claims 1 to 4, The reduction gear is a drug administration device in which multiple reduction gears are provided along the circumferential direction of the syringe holder.

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