Shell for Receiving an Injection System Comprising a Syringe Received in a Safety Device

20210016017 · 2021-01-21

    Inventors

    Cpc classification

    International classification

    Abstract

    The shell is intended to receive an injection system comprising a syringe received in a safety device which has: a body receiving the syringe; a shield movable relative to the body, for covering a needle; finger flanges extending outwardly. The shell comprises a tubular housing receiving a distal portion of the safety device and a casing receiving the finger flange, and further comprising: several snap features which flex outwardly during insertion of the finger flange in the casing, the finger flange being inserted distally from a distal face of the snap feature in the mounted position; and a protrusion located distally from each distal face, which exerts an inward biasing force on the finger flange in the mounted position.

    Claims

    1.-15. (canceled)

    16. A shell for receiving an injection system comprising a syringe received in a safety device, the safety device comprising: a body configured to receive the syringe; a shield movable relative to the body and configured to cover at least part of a syringe needle; and at least one finger flange extending outwardly from the body or the safety shield, wherein the shell extends along a longitudinal axis and comprises: a housing which is substantially tubular and configured to receive at least a distal portion of the safety device; and a casing configured to receive the finger flange of the safety device, wherein the casing comprises: at least two snap features configured to flex outwardly during insertion of the finger flange in the casing so that the finger flange is insertable distally from a distal face of the snap feature; and a protrusion located distally from each snap feature distal face, the protrusion configured to exert an inward biasing force on the finger flange once the finger flange is inserted distally from the distal face of the snap feature.

    17. The shell according to claim 16, wherein the shell is made as one single piece.

    18. The shell according to claim 16, wherein the protrusion has a holding face configured to push the finger flange inwardly, the holding face extending along a direction secant to the snap feature distal face.

    19. The shell according to claim 16, wherein the snap feature further comprises a sloped proximal face for facilitating insertion of the safety device in the shell.

    20. The shell according to claim 16, wherein the protrusion has a sloped proximal face for facilitating insertion of the safety device in the shell.

    21. The shell according to claim 16, wherein each protrusion protrudes distally from one snap feature thereby forming a single tab with the snap feature, wherein the tab is configured: to elastically flex outwardly during insertion of the safety device in the shell to allow insertion of the finger flanges distally from the distal face of the snap feature; and to exert an inward biasing force on the finger flange when the finger flange is located distally from the distal face of the snap feature.

    22. The shell according to claim 21, wherein one wall of the casing comprises a slot which substantially has the shape of a U having two legs extending longitudinally and a base orthogonal to the shell axis, the area of the casing wall located inside the slot forming said tab.

    23. The shell according to claim 16, wherein the protrusion comprises at least two protrusions each arranged on one lateral wall of the casing, the protrusions being opposed relative to the axis along a lateral direction.

    24. The shell according to claim 16, wherein the protrusion comprises one protrusion on each one of the opposed lateral walls of the casing.

    25. The shell according to claim 16, wherein the casing forms an enlarged portion of the shell with respect to the housing, said enlarged portion extending in a lateral direction.

    26. The shell according to claim 16, further comprising a distal end provided with an inner compartment configured to receive a cap remover.

    27. The shell according to claim 16, further comprising at least four ribs inside the housing, the ribs configured to center the safety device in the shell.

    28. A safety system for a syringe, comprising: a safety device having a body configured to receive the syringe, and a shield movable relative to the body and configured to cover a syringe needle, the shield having finger flanges which extend laterally adjacent to a proximal end of the shield; and a shell according to claim 16, the safety device mounted in the shell, the finger flanges of the safety device shield maintained relative to the shell by the snap feature and the protrusion.

    29. A syringe system comprising: a safety system comprising: a safety device having a body configured to receive the syringe, and a shield movable relative to the body and configured to cover a syringe needle, the shield having finger flanges which extend laterally adjacent to a proximal end of the shield; a shell according to claim 16, the safety device mounted in the shell, the finger flanges of the safety device shield maintained relative to the shell by the snap feature and the protrusion; and a syringe inserted in the body of the safety device, the syringe comprising a needle.

    30. The syringe system according to claim 29, wherein the shell has a length such that, in a amounted position, the needle exceeds a distal end of the shell of a pre determined length.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0049] FIG. 1 shows an embodiment of a syringe system according to the invention.

    [0050] FIG. 2 is an exploded view of an injection system which can be inserted in a shell according to the invention to form a syringe system.

    [0051] FIG. 3 shows the injection system before use.

    [0052] FIG. 4 shows the injection system once injection is completed and the system has been removed from the injection site.

    [0053] FIG. 5 is an enlarged view of detail A of FIG. 1.

    [0054] FIG. 6 is a perspective top view of the syringe system of FIG. 1.

    [0055] FIG. 7 is a detailed view of the shell showing a snap feature and a protrusion.

    [0056] FIG. 8 is a cross section of the safety system showing the protrusions tightening one finger flange of the safety device shield.

    [0057] FIG. 9 is a perspective partial view of the safety system.

    [0058] FIG. 10 is a cross section of the safety system along plane P9 of FIG. 9.

    [0059] FIG. 11 is a perspective partial view of the safety system.

    [0060] FIG. 12 is a cross section of the safety system along plane P11 of FIG. 11.

    [0061] FIG. 13 is a perspective view of the safety system.

    [0062] FIG. 14 is a cross section of the safety system along plane P13 of FIG. 13.

    [0063] FIG. 15 an enlarged view of detail B of FIG. 14.

    [0064] FIGS. 16a-16c schematically illustrates successive configurations of the syringe system during insertion of the injection system into the shell.

    [0065] FIG. 17 is a cross section of the syringe system, showing centring ribs.

    [0066] FIG. 18 is another cross section of the syringe system, showing an insertion stop.

    DESCRIPTION OF THE INVENTION

    [0067] FIGS. 1 and 2 shows a syringe system 100 which comprises an injection system 101 and a shell 50 for receiving the injection system 100.

    [0068] The injection system 101 includes a syringe 10 and a safety device 103.

    [0069] The syringe 10 comprises a barrel 11preferably having a proximal outer flange 12a plunger rod 13 and a needle 14. A cap 15 may further be provided to cover the needle 14 before use, to avoid injuries and contamination. The cap 15 may be removably mounted on the proximal end of the barrel 11. The plunger rod 13 may further comprise a proximal member 16 pushed by a user's finger to perform injection, which can be disc-shaped.

    [0070] The safety device 103 is configured to receive the syringe 10. The safety device 103 comprises:

    [0071] a body 20 configured to receive the syringe 10;

    [0072] a shield 30 movable relative to the body 20 and capable of covering at least part of the syringe needle 14; and

    [0073] finger flanges 31 which extend laterally adjacent to a proximal end of the shield 30 or to a proximal end of the body 20. The finger flanges 31 have a distal face 34.

    [0074] The shell 50 and safety device 103 form a safety system 102 for the syringe 10. The syringe system 100 comprises the safety system 102 and the syringe 10.

    [0075] As shown on FIGS. 1 and 6, the shell extends along an axis 105. Preferably, the syringe system 100 and its constitutive parts have the same axis 105. Longitudinal direction Z is defined as the direction of axis 105. The terms distally and proximally are used with reference to said longitudinal direction Z. Lateral direction X is defined as a direction orthogonal to axis 105 and as being the general direction along which the finger flanges 31 of the shield 30 extend. The transverse direction Y is defined as the direction orthogonal to the longitudinal direction Z and to the lateral direction X.

    [0076] The syringe system 100, or at least part of its constitutive parts, may have one or two axes of symmetry, namely a lateral plane P1 parallel to (X,Z) and/or a transverse plane P2 parallel to (Y,Z).

    [0077] A non limiting example of an injection system 101 is illustrated in FIGS. 2, 3 and 4, and can be at least partially similar to the system described in WO 2013/159059, the disclosure of which is hereby incorporated by reference in its entirety.

    [0078] The syringe 10 is received in a tubular portion 23 of the body 20 and is secured in the mounted position by appropriate means, such as fasteners 21 projecting inwardly at the proximal part of the body 20. The flange 12 of the barrel 11 may be snapped between said fasteners and a wall 22 of the body 20 which extends orthogonally to axis 105 and which is located distally from the fasteners 21.

    [0079] The shield 30 preferably comprises a tubular portion 33 which receives the body 20. The shield 30 can move axially relative to the body 20. Before use, as shown in FIG. 3, the body 20 is maintained in position relative to the shield 30, against the action of a spring 45, for example by means of at least one clamp 32 which can cooperate with the fasteners 21 or another part of the body 20 (see FIG. 5).

    [0080] In an embodiment, as shown in FIG. 3, the needle 14 may extend beyond the distal end of the safety device 103 before use. When injection has been completed, the clamp 32 or other retaining member is released. This can be achieved by the action of the plunger rod 13, for example of the proximal member 16, which can cause the fasteners 21 to be freed from the clamps 32.

    [0081] As a result, when the injection system 101 has been removed from the patient's skin, the spring 45 causes the shield 30 to move distally relative to the body 20, thereby covering at least part of the needle 14, as shown in FIG. 4.

    [0082] In another embodiment (not shown), the needle 14 may be covered by the shield 30 before use of the injection system 101. Thus, during pricking, the shield 30 moves proximally relative to the body against the actin of the spring 45, so that the needle 14 can extend beyond the shield distal end. After injection has been completed and when the injection system 101 has been removed from the patient's skin, the spring 45 causes the shield 30 to move distally relative to the body 20, thereby covering at least part of the needle 14.

    [0083] The shell 50 comprises a housing 51 which is substantially tubular and configured to receive a distal portion of the safety device 103. The shell 50 further comprises a casing 52 configured to receive the finger flange 31 of the safety device.

    [0084] The casing 52 can form an enlarged portion of the shell 50 with respect to the housing 51, said enlarged portion extending in the lateral direction X. The casing can be located at the proximal part of the shell 50.

    [0085] The casing 52 may comprise two half-casings located on both sides of transverse plane P2.

    [0086] On each side of transverse plane P2, the casing 52 can have a distal face 53, preferably substantially orthogonal to axis 105, and a peripheral wall including two opposed lateral walls 54, preferably extending parallel to P1 and one transverse wall 55, preferably extending parallel to P2. As can be seen in FIG. 6, the junctions between one lateral wall 54 and the transverse wall 55 is curved, the casing 52 thus having a substantially U-shaped cross section. The proximal end of the casing 52 is open.

    [0087] In other words, the shell 50 can substantially have the shape of a T, when viewed along the transverse direction Y. This makes handling of the shell 50 easier, as the user can place his/her fingers on the distal face 53 of the casing 52.

    [0088] Moreover, the housing 51 may have two opposed lateral recesses 56 located distally from the casing 52, so that grasping the shell 50 is made even easier for the user.

    [0089] The distal end 57 of the shell 50 may be provided with an inner compartment 58 configured to receive a cap remover (not shown), and/or with an outer collar 59 allowing improving the proper positioning of the syringe system 100 on the injection site.

    [0090] The casing 52 comprises:

    [0091] at least two snap features 60 configured to secure the finger flange 31 of the safety device shield 30 in the mounted position; the snap feature 60 may act as an axial abutment which prevents the safety device 103 from moving proximally relative to the shell 50 and ultimately from being uncoupled from the shell 50; anda protrusion 70 associated with each snap feature. Each protrusion 70 projects inwardly. Each protrusion is configured to tighten the safety device 103 against the shell 50, so as to preventor at least limitshaking of the safety device 103 inside the shell 50. In the mounted position, the protrusions can push the finger flange of the safety device towards or against the shell for limiting or preventing a movement of the safety device relative to the shell.

    [0092] In the exemplary illustrated embodiment, the shell 50 comprises one set of one snap feature 60 and one protrusion 70 on each one of the opposed lateral walls 54 of the casing 52, i.e. four of such sets. However, other implementations could be envisaged provided they make it possible to provide satisfactory holding of the safety device 103 inside the shell 50.

    [0093] One snap feature 60 and one protrusion 70 can be arranged inwardly on one and the same tab 40. As shown on FIGS. 5 and 7, each lateral wall 54 of the casing 52 comprises a slot 41 which substantially has the shape of a U having two legs 42 extending longitudinally and a base 43 orthogonal to the shell axis 105. The area of the casing wall 54 located inside the slot 41 forms said tab 40. The tab 40 can be substantially rectangular and can extend longitudinally.

    [0094] The base 43 of the slot 41 may be located at the distal part of the slot 41, while the line 44 joining the ends of the legs 42 which are not connected to the base 43 may preferably be located at the proximal part of the slot 41. Said line 44 may form a hinge allowing the tab 40 to be deformed or to pivot outwardly.

    [0095] As seen in FIG. 7, the snap feature 60 can have a distal face 61 preferably orthogonal to the shell axis 105, which can be configured to form an abutment for securing the finger flange 31 in the mounted position. The snap feature 60 can further have a proximal face 62, preferably sloped for facilitating insertion of the safety device 103 in the shell 50.

    [0096] The protrusion 70 can have a holding face 71, preferably substantially longitudinal in a rest position or in the mounted position of the safety device 103 in the shell 50. The holding face 71 may be configured to push the finger flange 31 inwardly. The holding face 71 may be located distally from the distal face 61. The protrusion 70 can have a proximal face 72, preferably sloped for facilitating insertion of the safety device 103 in the shell 50.

    [0097] The holding face 71 can be configured so as to increase the gripping effect on the finger flange 31. To that end, the holding face 71 may have a specific surface condition (such as micro-reliefs), or may be covered by a thin film of an appropriate material, such as a thermoplastic elastomer (TPE) or a thermoplastic polyurethane (TPU). An increased gripping effect makes it possible to further reduce shaking between the safety device 103 and the shell 50.

    [0098] The protrusion 70 may extend distally from the snap feature 60, and preferably also distally from the tab, partly in the slot base 43.

    [0099] One casing 52 and corresponding snap feature(s) 60, protrusion(s) 70 and possible tab(s) 40 can be made as one single piece. Preferably, the whole shell 50 can be made as one single piece. The process used can be injection of a plastic material, such as ABS (acrylonitrile butadiene styrene) or a copolymer ABSPC (polycarbonate).

    [0100] In practice, the syringe 10, preferably prefilled, is mounted in the safety device 103 to form the injection system 101. Then, the injection system 101 is inserted into the shell 50 up to the mounted position.

    [0101] During this insertion movement, as schematically shown in FIGS. 16a to 16c, the finger flanges 31 of the safety device shield 30 move distally relative to the shell 50, inside the casings 52.

    [0102] Initially, the tab 40, snap feature 60 and protrusion 70 are in the rest position, as illustrated in FIG. 16a.

    [0103] Then, as shown in FIG. 16b, the distal face 34 of the finger flange 31 comes into contact with the proximal face 62 of the snap feature 60, causing the tab 40 to elastically flex outwardly. This allows insertion of the finger flanges 31 distally from the distal face 61 of the snap feature 60.

    [0104] When the injection system 101 is the mounted position, i.e. at the end of the insertion movement into the shell 50, the finger flange 31 is located distally from the distal face of the snap feature 62, and secured in the mounted position owing to the distal face 61 of the snap feature 60, as shown in FIG. 16c.

    [0105] Moreover, as the distance D70 between the holding faces 71 of the protrusions 70, along direction Y, at rest, is smaller than the transverse dimension L31 of the finger flanges 31 (see FIG. 16b), when the injection system 101 is the mounted position, the protrusions 70 exert an inward biasing force on the finger flanges 31. In other words, each of the facing protrusions 70 pushes the finger flange 31 of the safety device shield 30 towards the other protrusion 70. The finger flange 31 is thus tightened between the protrusions 70, which limits or even prevents a movement of the safety device 103 relative to the shell 50.

    [0106] The protrusions 70 act as anti-vibration dampers for preventing the safety device 103 from shaking inside the shell 50.

    [0107] Thanks to the outward flexibility of the tab 40, the snap feature 60 is also flexed outwardly during insertion of the injection system 101. As a consequence, the length of the snap feature 60orthogonally to the tab 40, i.e. along the transverse direction Y in the exemplary embodimentcan be fairly great without hampering the insertion movement, in particular when the finger flange 31 comes into contact with the snap feature 60. Such a greater length of the snap feature 60 is advantageous as it provides a more efficient abutment for retaining the safety device 103 snapped inside the shell 50.

    [0108] Advantageously, the shell 50 may further comprise ribs 80 for centering the safety device 103 in the shell 50, preferably both during insertion and in the mounted position. These ribs 80 can be seen in FIG. 17, which is a cross section of the syringe system 100 in a plane orthogonal to axis 105, at the level of the lateral recesses 56 of the housing 51.

    [0109] The ribs 80 may extend over part or all of the inner face of the housing 50. The ribs 80 may project orthogonally inwardly from the inner face of the housing 50. They may contact or be located very close to the outer face of the tubular portion 33 of the shield 30.

    [0110] The shell 50 may comprise at least four ribs 80, and preferably six ribs 80, namely: two facing ribs 80a arranged on opposed transverse walls of the housing 50; and two sets of facing ribs 80b, 80c arranged on opposed lateral walls of the housing 50.

    [0111] Besides, the shell 50 can be provided with an insertion stop 81 configured to form an abutment for the injection system 101 in the mounted position, and to prevent said injection system 101 to further move distally relative to the shell 50 from said mounted position. The insertion stop 81 also allows controlling the appropriate mounted position. For that purpose, the insertion stop 81 can be adjusted or changed.

    [0112] There may be provided two insertion stops 81, preferably arranged opposite to one another relative to axis 105.

    [0113] As illustrated in FIG. 18, the insertion stop 81 can project inwardly from the distal face 53 of the casing 52, and can be configured to cooperate with the finger flanges 31. The insertion stop 81 may be formed in the continuity of one rib 80a, in plane P1.

    [0114] In the mounted position, as shown in FIG. 1, the needle 14 can extend beyond the distal end 57 of the shell 50 of a pre determined length. Preferably, in order to prevent needle injury, the needle is covered by the cap 15, which cap 15 can be covered by a cap remover as previously described. Once the cap 15 has been removed, the syringe system 100 is ready for use.

    [0115] By providing an outer shell, the invention makes the injection system 101 easier and less traumatic to use. By additionally preventing the safety device 103 from shaking inside the shell 50, the invention ensures that the safety device 103 is not damaged by its movements, and limits or prevents noises related to the shaking, which is detrimental to the perceived quality of the syringe system 100.

    [0116] The invention is of course not limited to the embodiments described above as examples, but encompasses all technical equivalents and alternatives of the means described as well as combinations thereof.