Connection tool
The connecting device addresses the issue of vial detachment by using a vial engaging piece and deformation restricting portion to securely attach the vial, while providing a forced release mechanism for intentional removal, ensuring reliable connection and mixing in syringe-vial systems.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- NIPRO CORP
- Filing Date
- 2025-10-14
- Publication Date
- 2026-04-23
AI Technical Summary
Existing connecting devices for syringes and vials face issues with the vial coming off due to the elasticity of the lid member, and the communication state between the syringe and vial spaces being disrupted by the double-headed needle being pushed back.
A connecting device with a double-ended needle member housed in a housing member, featuring a vial engaging piece that engages with the vial neck and a deformation restricting portion to maintain the vial in place, along with a forced release mechanism to allow intentional removal.
Prevents unintentional detachment of the vial while allowing intentional removal, ensuring reliable connection and mixing of contents between the syringe and vial.
Smart Images

Figure JP2025036219_23042026_PF_FP_ABST
Abstract
Description
Connecting device
[0001] The present invention relates to a connecting device for connecting a vial and a syringe.
[0002] Conventionally, a connecting device for connecting a vial and a syringe has been known in order to prepare a liquid medicine by mixing a powder preparation or the like in the vial and a dissolving solution or the like in the syringe. For example, the applicant has disclosed in Japanese Patent Application Laid-Open No. 2014-079331 (Patent Document 1) a connecting device for connecting a syringe and a vial. According to such a connecting device, after the internal space of the syringe and the internal space of the vial are communicated with each other and the powder preparation or the like in the vial is dissolved in the dissolving solution or the like in the syringe, the syringe removed from the connecting device can be used to administer a liquid medicine to a patient.
[0003] Japanese Patent Application Laid-Open No. 2014-079331
[0004] By the way, in the connecting device disclosed in Patent Document 1, the internal space of the syringe and the internal space of the vial are communicated with each other by a double-headed needle penetrating through the lid member of the syringe and the lid member of the vial, respectively. However, when the double-headed needle is punctured into an elastic lid member such as a rubber stopper, the double-headed needle may be pushed back by the elastic restoring force of the lid member, and the communication state of the internal space may be released. In Patent Document 1, the syringe and the connecting device are connected by a screw structure to prevent the release of the punctured state on the syringe side. On the other hand, since the vial is only fitted into the connecting device, there is a possibility that the vial may come off from the connecting device due to the elasticity of the lid member of the vial.
[0005] The problem to be solved by the present invention is to provide a novel connecting device that can prevent the vial from coming off.
[0006] Hereinafter, preferred embodiments for understanding the present invention will be described. However, each of the embodiments described below is described illustratively, and not only can be adopted in appropriate combinations with each other, but also for the plurality of components described in each embodiment, they can be recognized and adopted independently as much as possible, and can also be adopted in combination with any of the components described in another embodiment as appropriate. Thereby, in the present invention, various other embodiments can be realized without being limited to the embodiments described below.
[0007] The first embodiment is a coupling device in which a double-ended needle member is housed in a housing member so as to be movable in the needle axis direction, the double-ended needle member comprising a syringe mounting portion to which a syringe is detachably attached, a vial mounting portion to which a vial is attached, and a double-ended needle that connects the syringe and the vial, the vial mounting portion of the double-ended needle member is provided with a vial engaging piece extending toward the insertion direction of the vial, the vial engaging piece is made capable of engaging with the neck portion of the vial inserted into the vial mounting portion, and the housing member is provided with a deformation restricting portion protruding toward the vial engaging piece from the syringe mounting side, and an engagement maintenance mechanism is configured such that when the double-ended needle member is pushed toward the housing member, the deformation restricting portion is positioned outside the vial engaging piece, thereby maintaining the vial engaging piece in the neck portion.
[0008] According to the connecting device constructed in accordance with this embodiment, when the double-ended needle is inserted into the vial, the vial engaging piece of the double-ended needle member enters into the neck of the vial, thereby preventing the vial from coming out due to engagement with the vial engaging piece. Since the vial engaging piece that has entered into the neck of the vial engages with the vial in a state where its protruding tip abuts against it, the engagement allowance with the vial can be easily adjusted with a large degree of freedom by changing the thickness of the protruding tip of the vial engaging piece.
[0009] Furthermore, since the deformation-restricting portion provided on the housing member is located outside the vial engaging piece, the vial engaging piece is prevented from coming out of the neck of the vial, and the vial engaging piece is maintained in a state where it is inserted into the neck, thus ensuring that the prevention of vial detachment through engagement with the vial engaging piece functions more reliably.
[0010] The second embodiment is a coupling device described in the first embodiment, wherein a forced release mechanism is provided that, by applying force to the vial in the direction of removal from the vial mounting portion, deforms the vial engaging piece of the vial mounting portion and the deformation restricting portion of the housing member outward, thereby forcibly releasing the engagement of the vial engaging piece with the neck portion of the vial.
[0011] The connecting device, structured according to this embodiment, prevents the vial from unintentionally coming loose while also allowing the vial to be removed from the vial mounting section as needed. In particular, by appropriately setting the magnitude of the force required in the pulling direction to operate the forced engagement release mechanism, it is possible to effectively prevent the vial from unintentionally coming loose while allowing the vial to be removed by intentional pulling force.
[0012] A third aspect is the coupling device described in the second aspect, wherein the forced disengagement mechanism is configured such that the protruding tip surface of the vial engaging piece, which engages with the neck portion of the vial, is a tapered surface that widens toward the protruding tip side of the vial engaging piece.
[0013] According to the connecting device constructed in this embodiment, by applying a force in the pulling direction to the vial and pressing the vial against the tapered surface of the vial engaging piece, an outward component force that releases the vial engaging piece from entering the neck of the vial can be applied to the vial engaging piece. Therefore, a forced release mechanism that releases the engagement between the vial and the vial engaging piece can be constructed by simply applying a force in the pulling direction to the vial, using a simple structure in which a tapered surface is set on the protruding tip surface of the vial engaging piece.
[0014] The fourth embodiment is a connecting device described in any one of the first to third embodiments, wherein a plurality of vial engaging pieces are provided apart from each other in the circumferential direction of the vial mounting portion, and a plurality of deformation restricting portions are provided apart from each other in the circumferential direction of the housing member.
[0015] According to the connecting device constructed in this embodiment, the vial engaging pieces provided at multiple locations in the circumferential direction can more reliably prevent the vial from coming loose. Moreover, since each of the multiple vial engaging pieces is maintained in a state of being inserted into the neck of the vial by an engagement maintenance mechanism provided by a deformation restricting part, the vial coming loose is more reliably prevented. In some cases, the inner diameter of the protruding tip of the vial engaging piece that is capable of being inserted into the neck of the vial may be smaller than the outer diameter of the head of the vial, causing elastic deformation toward the outer circumference when passing over the head of the vial. However, in such cases, the multiple vial engaging pieces, which are mutually independent in the circumferential direction, can easily tolerate elastic deformation toward the outer circumference.
[0016] The fifth embodiment is a connecting device described in any one of the first to fourth embodiments, wherein the vial engaging piece is inclined inward toward the tip.
[0017] According to the connecting device constructed in this embodiment, the vial engaging piece, which has moved over the head of the vial, automatically enters the neck of the vial due to its elastic restoring force. As a result, simply by inserting the vial into the vial mounting section, a mechanism to prevent the vial from coming loose is established by the engagement of the vial engaging piece.
[0018] The sixth embodiment is a connecting device described in any one of the first to fifth embodiments, wherein the deformation restricting portion is inclined inward toward the vial engaging piece in an initial state where no external force is acting, and the deformation restricting portion is located outside the vial engaging piece and constitutes the engagement maintenance mechanism, and the angle of inclination toward the inward circumference is smaller than in the initial state due to contact with the vial engaging piece.
[0019] According to the connecting device constructed in accordance with this embodiment, the vial engaging piece is pushed in the direction of entering the neck of the vial by the elastic force of the deformation restricting part. As a result, the engagement of the vial engaging piece with the neck of the vial is difficult to release, and the vial is more reliably prevented from coming loose.
[0020] Based on the difference between the inclination angle of the deformation restricting part in the initial state and the inclination angle of the deformation restricting part in the state in which the engagement maintenance mechanism is configured, the magnitude of the force that maintains the engagement of the vial engaging piece with respect to the neck of the vial in the engagement maintenance mechanism can be adjusted.
[0021] According to the present invention, a connecting device for linking a syringe and a vial can prevent the vial from coming loose.
[0022] A perspective view of a drug preparation device equipped with a connecting device as a first embodiment of the present invention. A perspective view of a housing member constituting the drug preparation device shown in Figure 1, corresponding to the II-II section of Figure 3, a front view of the housing member shown in Figure 4, a perspective view of a double-ended needle member constituting the drug preparation device shown in Figure 1, a plan view of the double-ended needle member shown in Figure 6, a front view of the double-ended needle member shown in Figure 6, a cross-sectional view of the IX-IX section of Figure 7, and an exploded perspective view of a cap unit constituting the drug preparation device shown in Figure 1. A perspective view of the nest syringe constituting the drug preparation device shown in Figure 1. A cross-sectional view of the drug preparation device in Figure 1 showing the second needle portion punctured into the lid member of the vial, corresponding to the XII-XII section in Figure 13. A cross-sectional view of the drug preparation device in Figure 1 showing the first needle portion punctured into the syringe cap, corresponding to the XIV-XIV section in Figure 15. A cross-sectional view of the drug preparation device in Figure 1 showing the syringe detached from the connecting device.
[0023] Embodiments of the present invention will be described below with reference to the drawings.
[0024] Figures 1 to 3 show a connecting device 10 as a first embodiment of the present invention. The connecting device 10 connects a syringe 12 containing a dissolving solution, etc., and a vial 14 containing a powder formulation, etc. Figures 1 to 3 show a drug preparation device 16 with the syringe 12 attached to the connecting device 10 in its initial state before the vial 14 is attached. In the following description, the axial direction refers to the needle axis direction of the transfer needle 48 provided on the connecting device 10 (described later), and the central axis direction of the substantially cylindrical housing member 18 (described later) that houses the transfer needle 48, which is the vertical direction in Figure 2. Furthermore, although the vertical direction refers to the vertical direction in Figure 2, the actual direction of use of the connecting device 10 is not limited to the vertical direction, etc.
[0025] More specifically, the connecting device 10 has a structure in which a double-ended needle member 20 is inserted into a housing member 18. The double-ended needle member 20 is housed in the housing member 18 so as to be movable relative to it in the axial direction. The connecting device 10 has a syringe mounting section 24 on one axial opening side (upper opening 22a side) of the housing member 18 into which a syringe 12 can be attached, and a vial mounting section 26 on the other axial opening side (lower opening 22b side) of the housing member 18 into which a vial 14 can be attached.
[0026] The housing member 18 is formed of, for example, synthetic resin. As shown in Figures 4 and 5, the housing member 18 has a substantially stepped cylindrical shape, with the lower side having a larger diameter than the upper side. The lower side is a large-diameter cylindrical portion 28, and the upper side is a small-diameter cylindrical portion 30 with a smaller diameter than the large-diameter cylindrical portion 28. In this embodiment, the large-diameter cylindrical portion 28 is substantially cylindrical, while the small-diameter cylindrical portion 30 has a cylindrical circumferential wall that bulges outward on both radial sides (both left and right sides in Figure 2). That is, the small-diameter cylindrical portion 30 has bulging portions 32, 32 that bulge outward on both opposing radial sides, and the inner and outer diameters are partially enlarged at the locations where the bulging portions 32, 32 are formed. The large-diameter cylindrical portion 28 and the small-diameter cylindrical portion 30 are connected by an annular wall portion 34. In this embodiment, the annular wall portion 34 is slightly inclined downward toward the outer circumference. The size and shape of the housing member 18 can be appropriately changed depending on the vial 14 to which it is installed.
[0027] The annular wall portion 34 is provided with elastic pieces 36 that serve as deformation restricting portions. Multiple elastic pieces 36 are provided, spaced apart from each other in the circumferential direction, and in this embodiment, a pair of elastic pieces 36 facing each other in the radial direction (left-right direction in Figure 5) are provided. Note that there may be three or more elastic pieces 36, for example, they may be provided at approximately equal intervals, spaced apart from each other in the circumferential direction.
[0028] The elastic piece 36 protrudes downward from the annular wall portion 34. As shown in Figure 2, in the initial state before the vial 14 is mounted in the drug preparation device 16, the elastic piece 36 is inclined inward as it goes downward. In this embodiment, the elastic piece 36 extends below the vertical center of the large-diameter cylindrical portion 28. Furthermore, the elastic piece 36 is relatively thin-walled and is elastically deformable in the radial direction (left-right direction in Figure 2), which is the thickness direction.
[0029] As shown in Figures 2, 4, and 5, the elastic piece 36 is provided with a projection 38 that protrudes inward from the central part in the circumferential direction. The projection 38 has a height that increases downward, and its lower end surface is an inclined surface that slopes upward toward the inner circumference. The central part of the elastic piece 36 where the projection 38 is formed is radially thicker than the parts on both sides of the circumferential direction away from the projection 38. The lower end surface of the elastic piece 36 located on the outer circumference side of the projection 38 is approximately perpendicular to the vertical direction.
[0030] Furthermore, the inner circumferential surface of the large-diameter cylindrical portion 28 is provided with multiple axial ribs 40 that protrude inward and extend axially (vertically). In this embodiment, the axial ribs 40 are provided along substantially the entire vertical length of the large-diameter cylindrical portion 28. In this embodiment, two axial ribs 40 are provided between each elastic piece 36, 36 in the circumferential direction, so that four axial ribs 40 are provided spaced apart from each other in the circumferential direction. The number of axial ribs 40 is not limited to four, but it is preferable to provide multiple ribs. The cross-sectional shape of the axial ribs 40 is not limited, but in this embodiment, it is a substantially V-shaped cross-section that narrows towards the inner circumferential side.
[0031] Furthermore, an inner wall portion 42 is provided on the inner circumference side of the small-diameter cylindrical portion 30. In the peripheral wall portions other than the bulging portions 32, 32, the inner wall portion 42 is formed as a convex portion that protrudes from the inner surface of the small-diameter cylindrical portion 30 and extends in the circumferential direction, as shown in Figure 2. On the peripheral wall portions of the bulging portions 32, 32, it is formed as an inner circumferential wall portion that is radially separated inward from the inner surface of the small-diameter cylindrical portion 30 and extends in the circumferential direction, as shown in Figure 3.
[0032] Furthermore, in the inner wall portion 42, the inner circumferential wall-like portions located on the inner circumference side of each of the bulging portions 32, 32 are elastic locking pieces 44, 44 that extend downward, as shown in Figure 3. The protruding base portions (upper portions of the inner wall portion 42) 46a, 46a of these elastic locking pieces 44, 44 are substantially flat and spread in the vertical direction, while the protruding tip portions (lower portions of the inner wall portion 42) 46b, 46b of the elastic locking pieces 44, 44 are inclined inward in the opposing direction. The protruding tip portions 46b, 46b of these elastic locking pieces 44, 44 are elastically deformable in the opposing direction (left-right direction in Figure 3).
[0033] The double-ended needle member 20 inserted into the housing member 18 is equipped with a transfer needle 48 as a double-ended needle that connects the syringe 12 and the vial 14, as shown in Figures 2, 3, and 6 to 9. The transfer needle 48 extends straight in the vertical direction and is equipped with an upper projection 50 that protrudes toward the syringe 12 and a lower projection 52 that protrudes toward the vial 14. The ends of these upper projection 50 and lower projection 52 are sharpened. The transfer needle 48 is a hollow needle with needle tips at both the upper and lower ends, as shown in Figures 2, 3, and 9. In this embodiment, the opening on the syringe 12 side of the transfer needle 48 is formed on a tapered blade surface at the upper end of the upper projection 50, while the opening on the vial 14 side is formed on the conical outer surface at the lower end of the lower projection 52, but the specific shape is not limited. The lower end of the upward projection 50 is a tapered portion 54 whose outer diameter increases towards the bottom.
[0034] Furthermore, the double-ended needle member 20 has an annular plate-shaped bottom wall portion 56 that widens outward at the upper and lower central portion of the transfer needle 48. The double-ended needle member 20 also has a substantially cylindrical peripheral wall portion 58 that protrudes downward from the outer peripheral edge of the bottom wall portion 56. In other words, the upper projection portion 50 and the lower projection portion 52 of the transfer needle 48 protrude from the central portion of the bottom wall portion 56 toward both sides in the vertical direction, and the peripheral wall portion 58 is provided so as to surround the lower projection portion 52 of the transfer needle 48 at a position away from the outer circumference.
[0035] A pair of arms 60, 60 are provided projecting upward from the radially intermediate portion of the bottom wall 56, facing each other in the radial direction (left-right direction in Figure 7). At the protruding tip (upper end) of the arms 60, a deformation limiting portion 62 is provided, projecting inward in the opposing direction, to restrict the deformation of the elastic engagement portion 116 of the cap holder 92 (described later) toward the outer circumference. The arms 60 are plate-shaped and curved in the circumferential direction of the bottom wall 56, and the opposing inner surfaces of the deformation limiting portions 62 are not curved but are substantially flat.
[0036] On both sides (both left and right sides in Figure 9) of the circumferential wall portion 58 and the bottom wall portion 56 in a direction perpendicular to the opposing direction of the pair of arm portions 60, 60, notched housing regions 64 are formed that penetrate the upper part of the circumferential wall portion 58 and the outer peripheral end of the bottom wall portion 56, respectively. At both circumferential ends of the housing region 64, contact portions 66, 66 are provided that abut against the elastic piece 36 of the housing member 18. The contact portions 66 are roughly plate-shaped, integrally formed with the circumferential wall portion 58, and protrude from the circumferential wall portion 58 toward the housing region 64. The contact portions 66 are thinner in the radial direction than the circumferential wall portion 58, and their outer peripheral surfaces are located on the inner circumferential side than the outer peripheral surface of the circumferential wall portion 58. The upper end of the contact portion 66 has a shape in which multiple radially extending protrusions are arranged in a circumferential direction, and the outer peripheral surface is an inclined surface that slopes inward toward the inner circumference from upward. The contact portion 66 has a vertical dimension such that its upper end does not reach the bottom wall portion 56.
[0037] A vial engaging piece 68 is provided between the contact portions 66, 66 in the circumferential direction within the housing area 64. The vial engaging piece 68 is substantially plate-shaped with its radial direction as the thickness direction. The vial engaging piece 68 is provided on the vial mounting portion 26 and extends upward in the direction of insertion of the vial 14 into the vial mounting portion 26, protruding into the housing area 64. The vial engaging piece 68 is elastically deformable in the thickness direction (radial direction of the circumferential wall portion 58). The vial engaging piece 68 is spaced apart from the contact portions 66, 66 with a gap in the circumferential direction, allowing for elastic deformation in the thickness direction independent of the contact portions 66, 66. The vertical dimension of the vial engaging piece 68 is smaller than that of the contact portions 66, and its upper end is located below the upper end of the contact portions 66. In this embodiment, the vertical dimension of the vial engaging piece 68 is less than or equal to half the vertical dimension of the contact portions 66. Multiple vial engaging pieces 68 are provided, spaced apart from each other in the circumferential direction. In this embodiment, a pair of vial engaging pieces 68 facing each other in the radial direction are provided in a pair of accommodating regions 64, 64. The vial engaging pieces 68 as a whole are inclined inward towards the protruding tip side (upper side). The pair of vial engaging pieces 68, 68 facing each other in the radial direction gradually approach each other in the opposing direction from the fixed end (base end) to the free end (tip end), and the minimum distance between the opposing surfaces of the tip portions is smaller than the maximum outer diameter dimension of the neck portion 148 of the vial 14 (outer diameter dimension of the head 146), which will be described later. The tip portion of each vial engaging piece 68 is designed to be able to fit into the neck portion 148 of the vial 14 mounted on the vial mounting portion 26. The protruding tip surface of the vial engaging piece 68 is a tapered surface 70 that widens in diameter toward the protruding tip side and is inclined downward toward the inward circumference. In this embodiment, the vial engaging piece 68 has an inner and outer circumferential surface at its protruding tip that is a straight cylindrical surface extending in the vertical direction.
[0038] On the outer circumferential surface of the peripheral wall portion 58, axial grooves 72 are provided at positions corresponding in the circumferential direction to the axial ribs 40 of the housing member 18. In this embodiment, four axial grooves 72 are provided on the outer circumferential surface of the peripheral wall portion 58. The cross-sectional shape of the axial grooves 72 corresponds to the shape of the axial ribs 40 of the large-diameter cylindrical portion 28 of the housing member 18. The axial grooves 72 are formed over substantially the entire length of the peripheral wall portion 58 in the vertical direction. When the housing member 18 and the double-ended needle member 20 are assembled, as described later, the axial ribs 40 are inserted into the axial grooves 72, allowing the double-ended needle member 20 to move axially along the axial ribs 40, while preventing the double-ended needle member 20 from rotating relative to the housing member 18.
[0039] Furthermore, on the inner circumferential surface of the peripheral wall portion 58, guide ribs 74 extending linearly in the axial direction are provided at positions corresponding in the circumferential direction to the axial grooves 72 on the outer circumferential surface. In this embodiment, four guide ribs 74 are provided on the inner circumferential surface of the peripheral wall portion 58. The guide ribs 74 are provided over substantially the entire axial length of the peripheral wall portion 58. The guide ribs 74 protrude inward from the inner circumferential surface of the peripheral wall portion 58, and the inner circumferential surface of the guide rib 74 is at substantially the same position as the inner circumferential surface of the contact portion 66 in the radial direction of the peripheral wall portion 58. Then, as will be described later, when inserting the vial 14 through the lower opening 76 of the peripheral wall portion 58 (double-ended needle member 20), the ring-shaped member 144 (described later) that constitutes the outer peripheral portion of the upper end of the vial 14 comes into contact with the inner peripheral surface of the contact portion 66 and the guide rib 74, so that the head 146 of the vial 14 is inserted into the double-ended needle member 20 (drug preparation device 16) from below without tilting.
[0040] As shown in Figures 2 and 3, in this embodiment, the connecting device 10 is formed by combining the housing member 18 and the double-ended needle member 20 with each other. Specifically, the double-ended needle member 20 is inserted through the lower opening of the housing member 18, and the bottom wall portion 56 and peripheral wall portion 58 of the double-ended needle member 20 are inserted into the large-diameter cylindrical portion 28 of the housing member 18. In addition, the pair of arms 60, 60 of the double-ended needle member 20 are inserted into the small-diameter cylindrical portion 30 of the housing member 18 through the gap between the bulging portions 32, 32 and the elastic locking pieces 44, 44 of the housing member 18. The double-ended needle member 20 protrudes downward from the housing member 18, and the upper opening 22a of the connecting device 10 is the upper opening of the housing member 18 (the upper opening of the small-diameter cylindrical portion 30), while the lower opening 22b is the lower opening of the double-ended needle member 20 (the lower opening of the peripheral wall portion 58).
[0041] In the initial state before the vial 14 is inserted, the deformation limiting portions 62, 62 provided on the arm portions 60, 60 are positioned above the elastic locking pieces 44, 44 of the housing member 18. The locking of the deformation limiting portions 62, 62 and the elastic locking pieces 44, 44 prevents the double-ended needle member 20 from moving downward relative to the housing member 18. In addition, each elastic piece 36 of the housing member 18, which is inserted from above into the housing area 64, 64 of the double-ended needle member 20, abuts against the upper end surfaces of the contact portions 66, 66 of the double-ended needle member 20 in a substantially vertical direction, preventing the double-ended needle member 20 from moving upward relative to the housing member 18. As a result, in the initial state before the vial 14 is inserted, the double-ended needle member 20 is assembled in a state where it is positioned vertically relative to the housing member 18.
[0042] Also, in the initial state of the connecting device 10 before the vial 14 is attached, the elastic piece 36 of the housing member 18 is separated from and projects upward, which is the syringe 12 mounting side, with respect to the vial engaging piece 68 of the double-headed needle member 20. As can also be understood from the fact that the elastic piece 36 abuts against the abutting portions 66, 66, the circumferential width dimension of the elastic piece 36 is made larger than that of the vial engaging piece 68. Both end portions of the elastic piece 36 are abutted against the abutting portions 66, 66, and the central portion of the elastic piece 36 provided with the protrusion 38 faces the vial engaging piece 68 in the vertical direction.
[0043] In the drug preparation device 16 of the present embodiment, the syringe 12 is assembled from the upper opening 22a of the connecting device 10. The syringe 12 of the present embodiment has a structure in which a lock collar 80 made of synthetic resin is attached to the syringe body 78. The material of the syringe body 78 is not limited, but in the present embodiment, it is formed of glass.
[0044] The syringe body 78 includes a barrel portion 82, and a nozzle portion 84 having an outer diameter and an inner diameter smaller than those of the barrel portion 82 is provided at the tip (lower end) of the barrel portion 82. An annular recess 86 that opens to the outer peripheral side is formed at the proximal end portion (upper end portion) of the nozzle portion 84. As a result, the outer diameter dimension of the nozzle portion 84 at the formation position of the annular recess 86 is made smaller than the outer diameter dimension of the portion adjacent to the annular recess 86 in the vertical direction. Note that the outer diameter dimension of the nozzle portion 84 gradually decreases from the proximal end toward the tip.
[0045] A cap unit 88 is attached to the syringe body 78. As shown in FIG. 10, the cap unit 88 of the present embodiment is composed of a lock collar 80, a cap 90 that covers the tip opening of the nozzle portion 84 of the syringe 12, and a cap holder 92 made of synthetic resin that holds the cap 90.
[0046] The lock collar 80 is generally substantially cylindrical, has a peripheral wall 94, and a plurality of locking portions 96 protruding inward are provided at an opening (upper opening) on one axial side of the peripheral wall 94 at substantially equal intervals and spaced apart from each other in the circumferential direction. Further, a concave groove 98 that opens to the outer peripheral side and extends in the circumferential direction is formed in the middle portion in the axial direction on the outer peripheral surface of the peripheral wall 94. Further, an internal thread 100 is formed on the inner peripheral surface of the peripheral wall 94.
[0047] The cap 90 is generally substantially cylindrical and is formed of an elastic body such as rubber. The cap 90 has a peripheral wall 102, and the inner diameter dimension of the peripheral wall 102 gradually decreases from one axial side (upper side) toward the other axial side (lower side). In a state where the cap 90 is attached to the nozzle portion 84 of the syringe 12, the peripheral wall 102 of the cap 9 on the nozzle portion 84 is externally fitted with a radial tightening allowance. Further, the opening on the other axial side of the peripheral wall 102 is closed by a closing portion 104 that is integrally formed with the peripheral wall 102 and extends in a direction perpendicular to the axis. The thickness dimension (vertical dimension) of the closing portion 104 is set to be relatively small and is smaller than the radial thickness dimension of the peripheral wall 102. In addition, the other axial side of the peripheral wall 102 has a thick portion 106 with an increased outer diameter dimension and is thicker than the one axial side.
[0048] The cap holder 92 has a substantially stepped cylindrical shape, with one axial side being a large-diameter portion 108 and the other axial side being a small-diameter portion 110. That is, an annular stepped portion 112 that extends in a direction perpendicular to the axis is formed in the middle portion in the axial direction of the cap holder 92, and the large-diameter portion 108 and the small-diameter portion 110 are connected by the stepped portion 112. The large-diameter portion 108 and the small-diameter portion 110 have substantially the same outer shape, and are shaped such that both sides in one direction in the radial direction of the cylinder (both left and right sides in FIG. 3) are partially cut off. As a result, on both the left and right sides in the left-right direction in FIG. 3 of the large-diameter portion 108 and the small-diameter portion 110, there are flat surfaces that extend in the vertical direction, and on both the left and right sides in the left-right direction in FIG. 2, there are curved surfaces.
[0049] Furthermore, at the boundary between the flat surface and the curved surface in the large-diameter portion 108, a slit 114 is formed that extends from the lower end in the axial direction for a certain length and penetrates through the thickness direction of the large-diameter portion 108. In addition, in the portion of the peripheral wall of the large-diameter portion 108 where a flat surface is formed, the space between the two slits 114, 114 in the circumferential direction is an elastic engagement portion 116 that can be elastically deformed in the thickness direction (left-right direction in Figure 3) of the peripheral wall of the large-diameter portion 108. The elastic engagement portion 116 has a certain length dimension (vertical dimension) and width dimension (circumferential dimension between the two slits 114, 114). At the middle portion in the length direction of the inner surface of this elastic engagement portion 116, an engagement projection 118 that protrudes toward the inner circumference is provided, and at the lower end of the elastic engagement portion 116, an engagement claw portion 120 is formed that protrudes inward in the opposing direction (left-right direction in Figure 3) as it goes downward. In this embodiment, the engaging projection 118 is also formed on the inner surface of the curved surface portion (both left and right sides in Figure 2) of the peripheral wall of the large-diameter portion 108.
[0050] Furthermore, in the peripheral wall of the small-diameter portion 110, a roughly rectangular first through-window 122 is formed in the lower part of the portion where flat surfaces are formed on both radial sides (both left and right sides in Figure 3), penetrating the small-diameter portion 110 in the thickness direction. The inner diameter of this small-diameter portion 110 is slightly smaller than the outer diameter of the thick-walled portion 106 of the cap 90, so that when the cap 90 and the cap holder 92 are assembled, the thick-walled portion 106 is compressed and press-fitted into the inner circumference of the small-diameter portion 110. In addition, the vertical dimension of the first through-window 122 is roughly equal to or slightly larger than the vertical dimension of the thick-walled portion 106, so that when the cap 90 and the cap holder 92 are assembled, the thick-walled portion 106 partially returns to its original shape and enters the first through-window 122. For example, the vertical dimension of the first through-window 122 may be made slightly smaller than the vertical dimension of the thickened portion 106 so that the thickened portion 106 that extends into the first through-window 122 is compressed vertically by the inner surface of the first through-window 122.
[0051] Furthermore, a pair of second through windows 123, 123 are formed radially between the pair of first through windows 122, 122 in the circumferential direction of the circumferential wall of the small-diameter portion 110. The upper end of the second through window 123 is at approximately the same vertical position as the upper end of the first through window 122, and the lower end reaches the outer peripheral end of the bottom plate portion 124 of the small-diameter portion 110, which will be described later, and opens downwards. In addition, the circumferential width dimension of the second through window 123 is smaller than that of the first through window 122. And, in the assembled state of the cap 90 and the cap holder 92, the thick portion 106 of the cap 90 fits into the second through window 123, similar to the first through window 122.
[0052] Furthermore, a bottom plate portion 124 that extends perpendicular to the axis is provided at the lower end of the small diameter portion 110, and a through hole that penetrates vertically is formed in the center of the bottom plate portion 124. This through hole constitutes the lower opening 126 of the cap holder 92.
[0053] The order in which these lock collars 80, caps 90, and cap holders 92 are assembled is not limited, but for example, first, the cap 90 is inserted through the upper opening (upper opening of the large diameter portion 108) 128 of the cap holder 92. As described above, the thickened portion 106 of the cap 90 is pressed into the small diameter portion 110 of the cap holder 92, and the thickened portion 106 partially fits into the first through windows 122, 122 and the second through windows 123, 123, thereby positioning the cap 90 in the vertical direction relative to the cap holder 92.
[0054] Subsequently, the lock collar 80 is inserted through the upper opening 128 of the cap holder 92. At this time, the lower end of the lock collar 80 pushes the engaging protrusions 118, 118 of the elastic engaging portions 116, 116 outward, and as the lower end of the lock collar 80 overcomes the engaging protrusions 118, 118, the elastic engaging portions 116, 116 return to their original shape and deform, causing the groove 98 of the lock collar 80 to engage with the engaging protrusions 118, 118 of the cap holder 92. This restricts the insertion of the lock collar 80 into the cap holder 92. In addition, the lower end of the peripheral wall 94 of the lock collar 80 is in contact with the engaging claw portions 120, 120 of the elastic engaging portions 116, 116 in the vertical direction. Furthermore, the lower end of the lock collar 80 can also be brought into contact with the engaging claws 120, 120 and the stepped portion 112 of the elastic engaging portions 116, 116, thereby restricting further insertion of the lock collar 80 into the cap holder 92.
[0055] As described above, the nozzle portion 84 of the syringe 12 is inserted into the assembled cap unit 88 from above, and the locking portion 96 of the lock collar 80 is locked into the annular recess 86 provided in the nozzle portion 84, thereby forming a nest syringe 130 with the cap unit 88 assembled to the syringe 12, as shown in Figure 11. In the nest syringe 130, the lock collar 80, which is a separate part from the syringe body 78, is fixedly attached to the nozzle portion 84 of the syringe body 78. Furthermore, since the outer diameter of the nozzle portion 84 of the syringe body 78 is larger than the inner diameter of the cap 90 of the cap unit 88, the nozzle portion 84 is inserted into the cap 90 in a press-fit state, and the opening on the tip side (nozzle portion 84 side) of the syringe body 78 is liquid-tightly sealed by the cap 90.
[0056] Then, the cap unit 88 of the nest syringe 130 is inserted and assembled through the upper opening 22a of the connecting device 10. Prior to the insertion of the cap unit 88 into the connecting device 10, the syringe body 78 is filled with a dissolving solution for drug preparation, and the opening on the base end of the syringe body 78 is liquid-tightly sealed by the gasket 132. In this assembly of the connecting device 10 and the nest syringe 130, the drug preparation device 16 of this embodiment is constructed by attaching the plunger 134 to the gasket 132 by screwing it in, etc. In this embodiment, the upper opening 22a into which the syringe 12 (nest syringe 130) is inserted is the upper opening of the small diameter cylindrical portion 30 of the housing member 18, and the syringe mounting portion 24 is configured to include the small diameter cylindrical portion 30.
[0057] When inserting the cap unit 88 into the connecting device 10, the small-diameter cylindrical portion 30 of the housing member 18, which does not have a bulging portion 32 and is curved in an arc shape, and the curved surface of the large-diameter portion 108 of the cap holder 92 are superimposed radially inward and outward during insertion. This allows the insertion operation to be performed while understanding the circumferential orientation of the connecting device 10 and the cap unit 88.
[0058] Here, the distance between the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44 of the housing member 18 (the left-right dimension in Figure 3) is made smaller than the width dimension of the bottom plate portion 124 of the cap holder 92 (the left-right dimension in Figure 3). As a result, the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44 are elastically deformed outward (outward in the left-right direction in Figure 3) when the cap unit 88 is inserted into the connecting device 10.
[0059] Then, the protruding tip portions 46b, 46b elastically return to their original shape as they overcome the base plate portion 124, and the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44 are inserted into the first through windows 122, 122 of the cap holder 92. As a result, the base plate portion 124 is positioned below the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44, and the protruding tip portions 46b, 46b and the base plate portion 124 come into contact with each other, preventing the cap unit 88 (syringe 12) from moving upward relative to the connecting device 10. When the protruding tip portions 46b, 46b are inserted into the first through windows 122, 122, the outer circumferential surface of the elastic engagement portion 116 and the outer circumferential surface of the elastic locking piece 44 are at approximately equal radial positions and are substantially continuous in the vertical direction.
[0060] In other words, in the housing member 18 of this embodiment, a locking mechanism 136 is provided on the opening side (upper opening 22a side) where the syringe 12 can be attached, which allows the insertion of the cap 90 and the cap holder 92 and prevents them from coming off. In short, as shown in Figure 3, the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44 in the housing member 18 elastically deform toward the outer circumference, allowing the insertion of the cap 90 and the cap holder 92, and preventing them from coming off by contacting the bottom plate portion 124 of the cap holder 92. Thus, the locking mechanism 136 is configured to include the protruding tip portions 46b, 46b of the elastic locking pieces 44, 44. To put it another way, in this embodiment, in the syringe mounting portion 24 of the housing member 18, the cap 90 is held attached to the nozzle portion 84 of the syringe 12 via the cap holder 92 by the locking mechanism 136 (protruding tip portions 46b, 46b).
[0061] Furthermore, in the direction perpendicular to the opposing direction of the elastic locking pieces 44, 44 (the left-right direction in Figure 2), the inner wall portion 42 of the housing member 18 and the stepped portion 112 of the cap holder 92 are superimposed in the vertical direction and in contact with each other. This restricts further insertion of the cap unit 88 (syringe 12) into the connecting device 10 and prevents downward movement of the cap unit 88 relative to the connecting device 10. As a result, the connecting device 10 and the cap unit 88 (syringe 12) are positioned relative to each other in the vertical direction.
[0062] In the assembled state of the connecting device 10 and the cap unit 88, the deformation limiting portions 62, 62 provided on the arms 60, 60 of the double-ended needle member 20 are located on the outer circumference of the engagement portion between the cap holder 92 and the lock collar 80, that is, the engagement portion between the engagement projection 118 and the recessed groove 98. Since the walls constituting the bulging portions 32, 32 of the small-diameter cylindrical portion 30 of the housing member 18 are located on the outer circumference of the arms 60, 60, deformation of the arms 60, 60 toward the outer circumference is prevented, and consequently, deformation of the elastic engagement portions 116, 116 of the cap holder 92 toward the outer circumference is also prevented. As a result, the engagement between the engagement projection 118 and the recessed groove 98 is maintained, and the cap unit 88 (syringe 12) is prevented from detaching from the connecting device 10. In other words, the connecting device 10 (drug preparation device 16) of this embodiment is provided with a holding mechanism 138 (see Figure 3) that holds the elastic engaging portions 116, 116 (engaging protrusions 118, 118) engaged with the grooves 98 of the lock collar 80. In particular, in this embodiment, the holding mechanism 138 is configured to include deformation limiting portions 62, 62 that are arranged on the outer circumference side of the elastic engaging portions 116, 116 and limit the deformation of the elastic engaging portions 116, 116 toward the outer circumference, thereby holding the elastic engaging portions 116, 116 engaged with the outer surface (groove 98) of the lock collar 80.
[0063] A vial 14 is attached to the connecting device 10 of the drug preparation device 16 described above. The vial 14 comprises a bottle-shaped vial body 140, a lid member 142 made of an elastic material such as rubber that seals the opening of the vial body 140, and a ring-shaped member 144 that crimps and fixes the vial body 140 and the lid member 142 from the outer circumference. The vial body 140 is provided with a neck portion 148 that is smaller in outer diameter than the head portion 146, extending downward from the head portion 146, which is the upper end. The neck portion 148 has a roughly cylindrical shape with a small diameter at the bottom, and the upper part becomes thicker as the outer diameter gradually increases upward. Therefore, the outer circumferential surface of the upper part of the neck portion 148 is a tapered surface 150 that slopes outward upward. The lower end of the ring-shaped member 144 is superimposed on the tapered surface 150 of the neck portion 148, thereby liquid-tightly attaching the lid member 142 to the head 146 of the vial body 140. In addition, a thin-walled portion 152 is provided in the center of the lid member 142, which is thinner than the surrounding area, and the thin-walled portion 152 is exposed on the inner circumference side of the ring-shaped member 144. The vial 14 is filled with a powder formulation for drug preparation before the opening is sealed with the lid member 142.
[0064] To attach the vial 14 to the connecting device 10 of the drug preparation device 16, first, the vial 14 is brought close to the double-ended needle member 20 of the connecting device 10 from below, and the lid member 142 and head 146 of the vial 14 are inserted into the lower opening 22b of the connecting device 10. At the lower opening 22b of the connecting device 10, the lower surface of the guide rib 74 of the double-ended needle member 20 is inclined upward toward the inner circumference, so the guide rib 74 guides the vial 14 to the radial center of the double-ended needle member 20, and the downward projection 52 of the transfer needle 48 and the thin-walled portion 152 of the lid member 142 of the vial 14 are aligned in the vertical direction. Next, by further pushing the vial 14 upward into the drug preparation device 16, as shown in Figures 12 and 13, the downward projection 52 of the transfer needle 48 punctures the thin-walled portion 152 and penetrates the thin-walled portion 152. As can be seen from the above, the vial mounting portion 26 of this embodiment is configured to include the peripheral wall portion 58 of the double-ended needle member 20.
[0065] When inserting the vial 14 into the drug preparation device 16 and puncturing the thin-walled portion 152 with the downward projection 52 of the transfer needle 48, the elastic piece 36 of the housing member 18 and the contact portions 66, 66 of the double-ended needle member 20 abut against each other in a substantially vertical direction, preventing the double-ended needle member 20 from moving upward relative to the housing member 18. Therefore, by pushing the vial 14 into the double-ended needle member 20, the downward projection 52 of the transfer needle 48 can be stably punctured into the thin-walled portion 152 of the lid member 142.
[0066] When the vial 14 is inserted into the connecting device 10, as shown in Figure 12, the vial engaging piece 68 of the double-ended needle member 20 fits into the recess on the outer circumference of the neck portion 148 of the vial body 140, and is positioned below the head portion 146 of the vial body 140. That is, when the ring-shaped member 144 of the vial 14 passes between the opposing vial engaging pieces 68, 68, the vial engaging pieces 68, 68 are elastically pushed outward in the opposing direction, and the lid member 142 and head portion 146 of the vial 14 pass between the opposing vial engaging pieces 68, 68. After the head portion 146 passes, the deformation of the pair of vial engaging pieces 68, 68 is released, and they elastically return to their initial shape with the protruding tip side inclined inward, so that the tip portion fits into the neck portion 148 when the vial 14 is inserted.
[0067] When the vial 14 is fully inserted into the drug preparation device 16 (connecting device 10), and at least one of the ring-shaped member 144, which is the upper end of the vial 14, and the lid member 142, comes into contact with the bottom wall portion 56 of the double-ended needle member 20, the upper outer peripheral edge portion of the vial 14 (ring-shaped member 144) is pressed against the lower surface of the projection 38 on the elastic piece 36 of the housing member 18, as shown in Figure 12. As a result, a component force acting outward due to the ring-shaped member 144 abutting against the inclined lower end surface of the projection 38 causes the elastic piece 36 to be pushed outward (both sides in the left-right direction in Figure 12) by the vial 14. Consequently, the engagement between the elastic piece 36 of the housing member 18 and the contact portions 66, 66 of the double-ended needle member 20 is released on both sides of the projection 38, allowing the housing member 18 and the double-ended needle member 20 to move toward each other.
[0068] With the double-ended needle member 20 movable upward relative to the housing member 18, the vial 14 is further pushed and inserted into the drug preparation device 16 (connecting device 10), and the pushing force from the insertion of the vial 14 is applied to the double-ended needle member 20 having the transfer needle 48, causing the vial 14 and the double-ended needle member 20 to move upward relative to the housing member 18. As a result, as shown in Figures 14 and 15, the transfer needle 48 moves toward the syringe 12, and the upward projection 50 of the transfer needle 48 punctures the occlusion portion 104 of the cap 90 that covers the nozzle portion 84 of the syringe 12, penetrating the occlusion portion 104. In this way, the internal space of the syringe 12 and the internal space of the vial 14 are connected by the transfer needle 48. Furthermore, when the upward projection 50 of the transfer needle 48 is inserted into the closure portion 104 of the cap 90, the tapered portion 54 provided at the lower part of the upward projection 50 comes into contact with the inner circumferential surface of the lower end of the cap 90, thereby creating an airtight seal between the transfer needle 48 and the cap 90.
[0069] Then, with the syringe 12 and vial 14 connected, the plunger 134 of the syringe 12 is pushed toward the tip side (nozzle side 84 side), injecting the diluent, etc., inside the syringe 12 into the vial 14. As a result, the powdered preparation, etc., inside the vial 14 is mixed with the diluent, etc., and dissolved to prepare a liquid drug. After preparing the drug, the drug preparation device 16 is inverted and the plunger 134 is pulled toward the proximal end side (towards the user's hand), so that the drug inside the vial 14 is contained in the syringe 12.
[0070] When the vial 14 is inserted into the connecting device 10 and the syringe 12 and the vial 14 are connected, as shown in Figure 14, the vial engaging piece 68 of the double-ended needle member 20 is positioned around the neck portion 148 of the vial 14, and the tip portion (upper end portion) of the vial engaging piece 68 is positioned to overlap with the neck portion 148 of the vial 14 in vertical projection. Therefore, if the vial 14 tries to come out of the connecting device 10 in the opposite direction to the insertion direction, the vial engaging piece 68 abuts against the neck portion 148 of the vial 14, and the coming out of the vial 14 is prevented by engagement with the vial engaging piece 68.
[0071] Since the vial engaging piece 68 engages with the neck portion 148 of the vial 14 by abutting its protruding tip surface, the engagement allowance between the vial engaging piece 68 and the neck portion 148 of the vial 14 can be set with a large degree of freedom by adjusting the thickness dimension of the tip portion of the vial engaging piece 68. Therefore, it becomes easier to make adjustments such as making it less likely for the vial 14 to come loose from the connecting device 10, or making it relatively easy to remove the vial 14 using the forced engagement release mechanism 156 described later.
[0072] An elastic piece 36 of the housing member 18 is positioned on the outer circumference of the vial engaging piece 68, which is inserted into the neck portion 148 of the vial 14. As a result, the displacement of the vial engaging piece 68 toward the outer circumference (left and right outwards in Figure 14) is restricted by the elastic piece 36, and the engagement maintenance mechanism 154, which maintains the vial engaging piece 68 in the state of being inserted into the neck portion 148 of the vial 14, is composed of the elastic piece 36 as a deformation restricting part. By preventing the vial engaging piece 68 from unintentionally coming out of the neck portion 148 with the engagement maintenance mechanism 154, it is possible to prevent the vial 14 from coming out by a more reliable engagement between the neck portion 148 of the vial 14 and the vial engaging piece 68.
[0073] In particular, in this embodiment, the projection 38 of the elastic piece 36 of the housing member 18 abuts against the vial engaging piece 68 from the outer circumference. This makes it possible to more effectively maintain the state in which the vial engaging piece 68 is inserted into the neck portion 148 of the vial 14, and to more reliably prevent the vial 14 from detaching from the vial mounting portion 26.
[0074] In the configuration of the engagement maintenance mechanism 154, the elastic piece 36 is elastically deformed by contacting the vial engaging piece 68. The elastic piece 36 in contact with the vial engaging piece 68 has a smaller inclination angle toward the inner circumference in the vertical direction compared to the elastic piece 36 in its initial state before contact. In this way, the elastic piece 36 is in contact with the vial engaging piece 68 in an elastically deformed state, which helps to maintain a more stable engagement of the vial engaging piece 68 into the neck portion 148.
[0075] The large-diameter cylindrical portion 28 of the housing member 18 is located on the outer circumference side of the elastic piece 36 (left and right outwards in Figure 14), and the deformation of the elastic piece 36 toward the outer circumference is limited by contact with the large-diameter cylindrical portion 28. Therefore, the state in which the vial engaging piece 68 is inserted into the neck portion 148 by the elastic piece 36 is maintained more stably.
[0076] In particular, since the central portion of the elastic piece 36 is thickened by a projection 38 that protrudes toward the vial engaging piece 68, the elastic piece 36 fits between the large-diameter cylindrical portion 28 of the housing member 18 and the vial engaging piece 68, thereby more effectively restricting the deformation of the vial engaging piece 68 toward the outer circumference, and maintaining a more stable state of the vial engaging piece 68 being inserted into the neck portion 148.
[0077] When the vial 14 is inserted into the connecting device 10 and the syringe 12 and vial 14 are connected, the deformation limiting portion 62 of the double-ended needle member 20 is positioned above the outer circumference of the engagement portion between the cap holder 92 and the lock collar 80, that is, the engagement portion between the engagement protrusions 118, 118 and the groove 98. As a result, elastic deformation of the elastic engagement portions 116, 116 toward the outer circumference is permitted, and the engagement between the engagement protrusions 118, 118 and the groove 98 can be released by the elastic deformation of the elastic engagement portions 116, 116 toward the outer circumference.
[0078] Since the lock collar 80 is fixedly attached to the syringe body 78, when the syringe body 78 is pulled out from the connecting device 10, the elastic engaging portions 116, 116 elastically deform outward, releasing the engagement between the engaging protrusions 118, 118 and the groove 98, and the syringe 12 and lock collar 80 are removed from the connecting device 10 as shown in Figure 16. In particular, since both the lower inner surface of the groove 98 and the lower surface of the engaging protrusions 118, 118 are inclined upward toward the inner circumference, when the lock collar 80 is pulled upward, the contact between these inclined surfaces makes it easier for the elastic engaging portions 116, 116 to deform outward. As described above, the connecting device 10 (drug preparation device 16) of this embodiment is configured with a release mechanism that releases the engagement between the elastic engaging parts 116, 116 (engaging projections 118, 118) and the groove 98 of the lock collar 80 as the syringe 12 and the vial 14 are brought into communication by the transfer needle 48 through relative approach. When the syringe 12 is removed from the connecting device 10, the seal of the cap 90 at the tip opening of the nozzle part 84 is released. Therefore, to prevent the drug inside the syringe 12 from leaking out towards the tip, it is desirable to remove the syringe 12 from the connecting device 10 with the tip of the syringe 12 facing, for example, in the opposite direction (upward) from the direction of gravity.
[0079] The syringe 12, after being removed from the connecting device 10, is connected to, for example, an infusion line or a needle, and used to administer the drug contained in the syringe 12 to the patient through the infusion line or needle. Since the syringe 12, after being removed from the connecting device 10, is fitted with a lock collar 80 having a female thread 100, it can be connected to an infusion line or a needle by screwing the female thread 100 of the lock collar 80 onto the male thread of an infusion line connector or a needle hub of a needle.
[0080] Incidentally, the vial 14 remains attached to the connector 10 even after the syringe 12 has been removed from the connector 10, and can be disposed of together with the connector 10, for example. However, the connector 10 in this embodiment can also be removed from the vial 14, and the vial 14 and the connector 10 can be disposed of separately as needed.
[0081] In other words, when the vial 14 is pulled strongly downward against the connecting device 10, the neck portion 148 of the vial 14 is pressed against the protruding tip surface of the vial engaging piece 68. Since the protruding tip surface of the vial engaging piece 68 is a tapered surface 70 that slopes downward toward the inner circumference, when the force due to the contact of the neck portion 148 of the vial 14 is input downward to the tapered surface 70, a component force acts on the vial engaging piece 68 toward the outer circumference (left and right outwards in Figure 16). If this component force is greater than the force that tries to maintain the vial engaging piece 68 in the state of being inserted into the neck portion 148 of the vial 14 (engagement maintenance force by the engagement maintenance mechanism 154), the vial engaging piece 68 will slip out of the neck portion 148 of the vial 14 toward the outer circumference, and the vertical engagement between the vial 14 and the vial engaging piece 68 will be released. Therefore, by pulling the vial 14 downward with sufficient force, the vial 14 can be pulled out from the connecting device 10, and the vial 14 can be removed from the connecting device 10. Thus, the connecting device 10 of this embodiment is equipped with a forced engagement release mechanism 156 that forcibly releases the engagement of the vial engaging piece 68 with the neck portion 148 of the vial 14, and the forced engagement release mechanism 156 is configured such that the engagement surface of the vial engaging piece 68 with respect to the vial 14 is a tapered surface 70.
[0082] In this embodiment, the engagement surface of the neck portion 148 of the vial 14 with the vial engagement piece 68 is a tapered surface 150 that slopes downward toward the inner circumference. As a result, when the tapered surface 150 of the vial 14 is pressed against the protruding tip surface of the vial engagement piece 68, the force acting on the vial engagement piece 68 toward the outer circumference (left and right outer sides in Figure 16) becomes larger, making it easier to release the engagement between the vial engagement piece 68 and the vial 14.
[0083] The removal of the vial 14 from the connector 10 by such a forced release mechanism 156 is not permitted by force that may be unintentionally applied to the vial 14, but only when the vial 14 is intentionally and forcefully pulled out. The threshold tensile force at which the removal of the vial 14 is permitted can be set by, for example, the stiffness of the vial engaging piece 68, the stiffness of the elastic piece 36, the amount the vial engaging piece 68 penetrates the neck portion 148, and the clearance between the elastic piece 36 and the large-diameter cylindrical portion 28.
[0084] Furthermore, for example, the rigidity of the vial engaging piece 68, the rigidity of the elastic piece 36, the amount the vial engaging piece 68 penetrates the neck portion 148, and the clearance between the elastic piece 36 and the large-diameter cylindrical portion 28 prevent the vial 14 from detaching from the connecting device 10. In other words, it is possible to omit the forced disengagement mechanism. This would more reliably prevent the vial 14 from unintentionally coming loose from the connecting device 10.
[0085] Although embodiments of the present invention have been described in detail above, the present invention is not limited by its specific description. For example, the connecting device 10 does not necessarily have to be pre-attached to the syringe body 78. Specifically, for example, the connecting device 10 may be provided separately from the syringe 12, and when transferring the dissolving solution or the like to the vial 14, a medical professional may attach the connecting device 10 to the nozzle portion 84 of the syringe 12, which is fitted with a gasket 132 and a plunger 134 and contains the dissolving solution or the like.
[0086] The protruding tip surface of the vial engaging piece 68, which is the engagement surface with the neck portion 148 of the vial 14, is not necessarily limited to a tapered surface 70. For example, in cases where a forced release mechanism that allows the vial 14 to be separated from the connecting device 10 is not provided, the engagement surfaces of the neck portion 148 of the vial 14 and the vial engaging piece 68 may be surfaces that are substantially perpendicular to the withdrawal direction of the vial 14, so as to make it difficult to release the engagement.
[0087] The vial engaging pieces 68 are not limited to a pair facing each other in the radial direction, but may be provided in three or more positions in the circumferential direction, for example. In this case, deformation restricting portions (elastic pieces 36) are arranged at positions corresponding to the vial engaging pieces 68 in the circumferential direction. The vial engaging pieces 68 may be a single C-shaped annular piece that extends beyond half a circumference in an axial view. In addition, the vial engaging pieces 68 may be in the shape of a rod or other shapes, as illustrated in the example, such as a flat plate or a curved plate.
[0088] In the first embodiment, the vial engaging piece 68 is shaped to be inclined inward toward the protruding tip, and automatically fits into the neck portion 148 of the vial 14 when the vial 14 is inserted into the vial mounting portion 26. However, the vial engaging piece 68 may not be inclined with respect to the insertion direction (axial direction) of the vial 14 into the vial mounting portion 26, or it may be shaped to be inclined outward toward the protruding tip. In this case, for example, the deformation restricting portion (elastic piece 36) pushes the vial engaging piece 68 inward, causing the vial engaging piece 68 to fit into the neck portion 148 of the vial 14.
[0089] In the first embodiment, the syringe body 78 was made of glass, but it may be made of synthetic resin, for example. Also, the syringe body 78 and the lock collar 80 may be formed as a single molded product made of synthetic resin, for example.
[0090] In the first embodiment, the double-ended needle member 20 was integrally molded from synthetic resin, but it may also be constructed by bonding together multiple separately molded parts, for example, or by using different materials in parts through insert molding or multi-color molding. Therefore, for example, the transfer needle 48 in the double-ended needle member 20 can be made of metal.
[0091] 10 Connecting device (first embodiment) 12 Syringe 14 Vial 16 Drug preparation device 18 Housing member 20 Double-ended needle member 22a Upper opening 22b Lower opening 24 Syringe mounting section 26 Vial mounting section 28 Large diameter cylinder section 30 Small diameter cylinder section 32 Bulging section 34 Annular wall section 36 Elastic piece (deformation restricting section) 38 Projection 40 Axial rib 42 Inner wall section 44 Elastic locking piece 46a Protruding base section 46b Protruding tip section 48 Transfer needle (double-ended needle) 50 Upper projection section 52 Lower projection section 54 Tapered section 56 Bottom wall section 58 Circumferential wall section 60 Arm section 62 Deformation restricting section 64 Housing area 66 Contact section 68 Vial engaging piece 70 Tapered surface 72 Axial groove 74 Guide rib 76 Lower opening 78 Syringe body 80 Lock collar 82 Barrel section 84 Nozzle section 86 Annular recess 88 Cap unit 90 Cap 92 Cap holder 94 Peripheral wall 96 Locking section 98 Groove 100 Female thread 102 Peripheral wall 104 Closure section 106 Thick-walled section 108 Large diameter section 110 Small diameter section 112 Step section 114 Slit 116 Elastic engagement section 118 Engaging projection 120 Engaging claw section 122 First through window 123 Second through window 124 Bottom plate section 126 Lower opening 128 Upper opening 130 Nest syringe 132 Gasket 134 Plunger 136 Locking mechanism 138 Holding mechanism 140 Vial body 142 Lid member 144 Ring-shaped member 146 Head 148 Neck 150 Tapered surface 152 Thin-walled section 154 Engagement maintenance mechanism 156 Forced engagement release mechanism
Claims
1. A connecting device comprising a double-ended needle member, which is housed in a housing member so as to be movable in the needle axis direction, the double-ended needle member having a syringe mounting portion to which a syringe is detachably attached, a vial mounting portion to which a vial is attached, and a double-ended needle that connects the syringe and the vial, wherein the vial mounting portion of the double-ended needle member is provided with a vial engaging piece extending toward the insertion direction of the vial, and the vial engaging piece is capable of engaging with the neck portion of the vial inserted into the vial mounting portion, and the housing member is provided with a deformation restricting portion that protrudes toward the vial engaging piece from the syringe mounting side, and an engagement maintenance mechanism is configured such that when the double-ended needle member is pushed toward the housing member, the deformation restricting portion is positioned outside the vial engaging piece, thereby maintaining the vial engaging piece in a state of being engaged with the neck portion.
2. The connecting device according to claim 1, which is provided with a forced release mechanism that forcibly releases the engagement of the vial with respect to the vial by applying force to the vial in the direction of removal from the vial mounting portion, thereby deforming the vial engaging piece of the vial mounting portion and the deformation restricting portion of the housing member outward.
3. The connecting device according to claim 2, wherein the forced disengagement mechanism is configured such that the protruding tip surface of the vial engaging piece that engages with the neck portion of the vial is a tapered surface that widens toward the protruding tip side of the vial engaging piece.
4. The coupling device according to any one of claims 1 to 3, wherein a plurality of vial engaging pieces are provided apart from each other in the circumferential direction of the vial mounting portion, and a plurality of deformation restricting portions are provided apart from each other in the circumferential direction of the housing member.
5. The connecting device according to any one of claims 1 to 3, wherein the vial engaging piece is inclined inward toward the tip.
6. The coupling device according to any one of claims 1 to 3, wherein the deformation restricting portion is inclined inward toward the vial engaging piece in an initial state where no external force is acting, and the deformation restricting portion is located outside the vial engaging piece and constitutes the engagement maintenance mechanism, and the angle of inclination toward the inward circumference is smaller than in the initial state due to contact with the vial engaging piece.
Citation Information
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