JP6650494B2 - Self-injection device with movable needle shroud - Google Patents

Description

  The subject of the present disclosure relates to a self-injection device for injecting a substance, such as a therapeutic agent, into a patient.

  Administration of a therapeutic agent, such as a pharmaceutical or biological agent, can be performed by injection, which can include, for example, subcutaneous or intramuscular injection. Injection devices, such as syringes or other containers containing a therapeutic agent in fluid communication with a needle or spout, can be manually operated by a user to make an injection. Injections are often performed by skilled medical personnel. Alternatively, the patient can be trained to use an injection device for self-injection. In addition, injection device containers such as syringes may be pre-filled with a therapeutic agent for use by a patient to prevent or control contamination of the therapeutic agent, and so that the patient does not need to fill the container. However, self-injection can be difficult for some patients, for example, because of less dexterity or fear of needles.

  Self-injection devices can help patients perform self-injections, as well as assist healthcare providers and others in performing injections. Self-injection devices can be used, for example, to assist in operating a manual injection device such as a standard prefilled syringe. Such devices may be configured, for example, to receive a standard pre-filled syringe and release the syringe after use, thus allowing the patient to use the self-injection device repeatedly. The self-injection device may include several features to assist the patient in manipulating the manual injection device, for example, removing the needle cap from the needle of the prefilled syringe and guiding insertion of the needle into the patient. . Various types of self-injection devices have been described in, for example, Utility Model Registration No. 3,143,302 and JP-A-2011-98133, each of which is incorporated herein by reference in its entirety. Invite to

Utility Model Registration No. 3,143,302 JP 2011-98133 A

  However, there is still a need for further improvements in known self-injection devices. For example, it may be desirable to have a self-injection device that allows the patient to operate comfortably and easily and hides the needle from the patient's view.

  The objects and advantages of the disclosed subject matter will be set forth in the description that follows, and will be apparent from and will be apparent from the practice of the disclosed subject matter. Further advantages of the disclosed subject matter will be realized and attained by the method and system particularly pointed out in the written description and claims hereof, as well as the appended drawings.

  To achieve these and other advantages, and according to the objects of the disclosed and embodied and generally described, the disclosed subject matter is a self-injection device for injecting a beneficial agent from a syringe. including. The syringe includes a barrel, a shoulder, a needle, a flange, a cap, and a plunger. The outer cylinder has a first end and a second end. The shoulder is adjacent the first end. The needle is in fluid communication with the barrel, has a proximal end and a distal end, and extends from a first end of the barrel. The flange is located proximate the second end of the outer cylinder. The cap covers the needle and is positioned at one end close to the shoulder. The plunger is movable within the barrel to expel the beneficial agent through the needle. The self-injection device includes a base and a shroud member. The base includes a base end, a front end, and an outer cylinder engaging portion. The outer cylinder engaging portion defines a cavity having a long axis, and a proximal end of the base for receiving at least a portion of the outer cylinder with the distal end of the needle extending a first distance from the distal end of the base. And the tip. The shroud member has a proximal end and a distal end. The base end of the shroud member is movably connected to the base. It is movable between a completely retracted position, which is a distance retracted from the distal end of the base. The extended distance is greater than or equal to the first distance, and the retracted distance is less than the first distance.

  As embodied herein, the shroud member may be biased toward the extended position. The tip of the shroud member may have a substantially planar engagement surface with a notch therein, or the tip of the shroud member may have a substantially planar engagement surface with a through hole therein. May be provided. The shroud member may include a tubular member disposed between a proximal end and a distal end of the shroud member.

  For example, as embodied herein, the base further comprises at least one flange engaging portion that receives at least a portion of the flange and defines a slot that inhibits movement of the barrel along the long axis. You may. The base may include a housing, and in some embodiments, the self-injection device may further include a cover. The cover may be hinged to the base and may be pivotable between an open position and a closed position relative to the base. The outer cylinder engaging portion may be movable with respect to the housing. The outer cylinder engaging portion may include a cap engaging portion. The cap engagement portion may have an opening sized to receive at least a portion of the first end of the outer cylinder. The cap engaging portion may be positioned to engage a cap end proximate the shoulder, and may be movable relative to the housing to move the cap away from the barrel. The cap engaging portion may include a U-shaped notch.

  Further, as embodied herein, the housing may include a bottom and at least one sidewall extending upwardly from the bottom. The cover may be coupled to the housing proximate at least one of the at least one side wall. At least one side wall may have a substantially round shape. The base may include a proximal surface extending from the bottom and perpendicular to the at least one sidewall. The proximal end surface may include an opening to receive at least a portion of the plunger therethrough when at least a portion of the barrel is disposed within the barrel engagement cavity.

  Further, as embodied herein, the cover may have one or more protrusions that engage the barrel when the cover is in the closed position. The cap engaging portion may be movable relative to the at least one flange engaging portion when the cover pivots from the open position to the closed position relative to the base. The syringe can be kept engaged when the cover moves to the closed position. The self-injection device may further include a flange adapter. The flange adapter may include a recess for receiving the flange and at least one wing element configured to engage the flange engagement.

  Further, as embodied herein, the base includes a lock that is movable between an unlocked position and a locked position when the cover pivots from the open position to the closed position relative to the base. A mechanism may be further provided. The proximal end of the shroud may include at least one locking projection. The locking projection may be configured to engage the locking mechanism when the locking mechanism is in the engaged position and the shroud is in the retracted position. The locking mechanism moves between the locked position and the unlocked position so as to disengage at least one locking projection when the cover is pivoted from the closed position to the open position with respect to the base. It may be movable. Alternatively, the cover may be configured such that when the cover is in the closed position, frictional engagement occurs between the outer cylinder engaging portion and the cap engaging portion.

  In addition, as embodied herein, beneficial agents may include TNF inhibitors.

  Further, according to the purpose of the disclosed subject matter embodied and described generally, the disclosed subject matter includes a kit. The kit includes a syringe and a device for self-injection. The syringe includes a barrel, a shoulder, a needle, a flange, a cap, and a plunger. The outer tube has a first end and a second end defining a long axis therebetween. The shoulder is adjacent the first end. The needle is in fluid communication with the barrel, has a proximal end and a distal end, and extends from a first end of the barrel. The flange is located proximate the second end of the outer cylinder. The cap covers the needle and is positioned at one end close to the shoulder. The plunger is movable within the barrel to expel the beneficial agent through the needle. The self-injection device includes a base and a shroud member. The base has a base end, a front end, and an outer cylinder engaging portion. The outer cylinder engaging portion is disposed between the proximal end and the distal end of the base to receive at least a portion of the syringe outer cylinder with the distal end of the needle extending a first distance from the distal end of the base. Define the voids that have been created. The shroud member has a proximal end and a distal end. The base end of the shroud member is movably connected to the base, and the shroud member has a completely extended position that is the distance that the tip of the shroud member extends from the tip of the base, and the tip of the shroud member has It is movable between a completely retracted position, which is a distance retracted from the distal end of the base. The extended distance is greater than or equal to the first distance, and the retracted distance is less than the first distance.

  It is to be understood that both the foregoing general description and the following detailed description are exemplary, and are intended to provide further explanation of the subject matter of the claimed disclosure.

  BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate by way of example the objects disclosed and are provided to provide a further understanding thereof. The drawings, together with the description, serve to explain the principles of the disclosed subject matter.

1 is a perspective view of a self-injection device according to an exemplary embodiment of the disclosed subject matter. FIG. 2 is a top view of the self-injection device of FIG. 1. FIG. 2 is a bottom view of the self-injection device of FIG. 1. FIG. 2 is a right side view of the self-injection device of FIG. 1, and the left side view is a mirror image of the right side view. FIG. 2 is a front view of the self-injection device of FIG. 1. FIG. 2 is a rear view of the self-injection device of FIG. 1. FIG. 2 is a perspective view of an exemplary shroud member of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary housing of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary cover of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary syringe engaging element of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary locking mechanism of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary back cover of the self-injection device of FIG. It is a top view of the back cover of FIG. FIG. 2 is a perspective view of an exemplary insert of the self-injection device of FIG. FIG. 2 is a perspective view of an exemplary insert of the self-injection device of FIG. FIG. 2 is an exploded view of various components of the exemplary self-injection device of FIG. 1. FIG. 2 is a bottom view of the self-injection device of FIG. 1 with the cover in an open position and the shroud member in a fully extended position. FIG. 2 is a bottom view of the self-injection device of FIG. 1 with the cover in a closed position and the shroud member in a fully extended position. FIG. 2 is a bottom view of the self-injection device of FIG. 1 with the cover in a closed position and the shroud member in a fully retracted position. FIG. 2 is a top perspective view of the self-injection device of FIG. 1 with the cover in an open position. FIG. 2 is a top view of the self-injection device of FIG. 1 with the cover in a closed position and shown in dashed lines for clarity. FIG. 2 is a perspective view of an exemplary syringe used in the self-injection device of FIG. FIG. 2 is a perspective view of the self-injection device of FIG. 1 with the cover in an open position and shown in dashed lines for clarity before inserting the syringe into the self-injection device. FIG. 2 is a perspective view of the self-injection device of FIG. 1 with the cover in the open position, shown in dashed lines for clarity, and the syringe inserted into the self-injection device; FIG. 2 is a perspective view of the self-injection device of FIG. 1 with the cover in the closed position, shown in dashed lines for clarity, and the syringe inserted into the self-injection device; FIG. 2 is a perspective view of the self-injection device of FIG. 1 with the cover in the closed position, shown in dashed lines for clarity, and the shroud member in a fully retracted position;

  Reference will now be made in detail to various exemplary embodiments of the disclosed subject matter, which are illustrated in the accompanying drawings. The structure of the disclosure and the corresponding method of operation will be described in connection with the detailed description of the system.

  The devices and methods provided herein can be used to inject a patient with any of a variety of suitable therapeutic agents or substances, such as drugs. As used herein, "self-injection device" or "self-injection aid" or "device" (used interchangeably herein) generally refers to an individual (herein referred to as a user). , Also referred to as a patient or health care provider) to administer a fluid substance, such as a therapeutic agent. In some embodiments, the device may be configured to accept a syringe or other injection device, but it could otherwise be used without a self-injection device. However, in alternative embodiments, a syringe or other injection device may function only by using a self-injection device. Useful solutions can include proteins. In some embodiments, beneficial solutions can include TNF inhibitors such as adalimumab, and the like.

  The syringe disclosed herein may include a barrel, a shoulder, a needle, a flange, a cap, and a plunger, for purposes of illustration and not limitation. The outer cylinder has a first end and a second end. The shoulder is adjacent the first end. The needle is in fluid communication with the barrel, has a proximal end and a distal end, and extends from a first end of the barrel. The flange is located proximate the second end of the outer cylinder. The cap covers the needle and is positioned at one end close to the shoulder. The plunger is movable within the barrel to expel the beneficial agent through the needle.

  In accordance with the subject matter of the present disclosure, a self-injection device for injecting a beneficial agent from a syringe generally comprises a base and a shroud member. The base has a base end, a front end, and an outer cylinder engaging portion. The barrel engaging portion defines a cavity having a major axis and a proximal end of the base for receiving at least a portion of the syringe barrel with the distal end of the needle extending a first distance from the distal end of the base. It is arranged between the part and the tip part. The shroud member has a proximal end and a distal end. The base end of the shroud member is movably connected to the base. It is movable between a completely retracted position, which is a distance retracted from the distal end of the base. The extended distance is greater than or equal to the first distance, and the retracted distance is less than the first distance.

  The accompanying figures, wherein like numbers refer to the same or functionally similar elements throughout the separate figures, further illustrate various embodiments, and illustrate various principles and advantages, all in accordance with the disclosed subject matter. Play a role. For purposes of illustration and not limitation, exemplary embodiments of a self-injection device are shown in FIGS. Although the subject of the present disclosure will be described with respect to the use of the device to provide subcutaneous injections, such as a TNF inhibitor such as adalimumab, those skilled in the art will appreciate that the subject It will be appreciated that the self-injection device can be used to inject a user with any suitable substance, including nutritional, pharmaceutical, or biological agents. Furthermore, the components and methods of use of the self-injection device are not limited to the exemplary embodiments described or shown herein.

  By way of example, and not limitation, referring to FIG. 22, an exemplary syringe 10 for use in a self-injection device according to the disclosed subject matter is shown. Syringe 10 may include an outer barrel 11 having a shoulder 12 proximate to first end 17 and a needle 13 (eg, shown in FIG. 26) extending from first end 17. The cap 15 can cover the needle 13 so as to prevent or suppress inadvertent sticking of the needle, and the end 21 may be located close to the shoulder 12. Syringe 10 may include a flange 14 surrounding an opening proximate second end 18. The needle 13 is in fluid communication with the outer cylinder 11 and includes a proximal end 20 closest to the first end 17 of the outer cylinder 11 and a distal end 19 extending therefrom. The plunger 16 can be inserted into an opening proximate to the second end 18 and can be movable within the barrel 11 to expel the beneficial agent through the needle 13.

According to the disclosed subject matter, a self-injection device 100 is provided. Referring to FIGS. 1-6, an exemplary self-injection device 100 includes a base 110 and a shroud member 120. The base 110 may include an outer cylinder engaging portion 112. Outer barrel engaging portion 112 defines a cavity having a major axis _xb to receive at least a portion of syringe barrel 11. Outer cylindrical engaging portion 112, tip 19 of the needle 13 is configured so as the distance D ₁ extending from the distal end 111 of the base 110, accepting the syringe barrel 11.

  Base 110 may be configured as an assembly of various components. FIGS. 8, 10-15 show exemplary embodiments of the components of the base 110 for purposes of illustration and not limitation. Alternatively, base 110 may be configured as an integral piece of material. The components of the base 110 generally include a housing 130 (FIG. 8), which may include a back cover 151 (FIGS. 12-13) and inserts 152, 153 (FIGS. 14-15, respectively), and a syringe keeper. A mating element 140 (FIG. 10) and a locking mechanism 150 (FIG. 11) may be provided.

  FIG. 8 shows an exemplary housing 130 of the base 110. As embodied herein, the housing 130 includes a bottom 131 and at least one side wall 132, 133 extending from the bottom 131. Alternatively, housing 130 may have a single side wall, or may have three or more side walls or sidewall portions. As shown, the sidewalls 132, 133 have a substantially rounded shape that can enhance ergonomics, and thus enhance user comfort and ease of use when holding and / or operating the device 100. May have. Alternatively, the sidewalls may be substantially planar, or have any other suitable shape. The bottom 131 may also include a biasing engagement member 135, which may be configured, for example, as a protrusion sized to engage the biasing member 23 (eg, shown in FIG. 19). Further, as embodied herein, the bottom 131 may include a biasing slot 137 sized to receive the biasing member 24 (eg, as shown in FIG. 19), as further described herein. And an engagement slot 136 sized to receive the locking mechanism 150.

  Further, as embodied herein, housing 130 may include a proximal surface 134 extending from bottom 131. Proximal surface 134 may also include a notch or opening 138. The opening 138 is sized to receive at least a portion of the plunger 16 therethrough when at least a portion of the barrel 11 is disposed within the barrel engagement cavity 112, as further described herein. You may. The housing 130 also includes a cover receiving hole 139 sized to receive the cover 160, as described further herein.

In some embodiments, base 110 may further include one or more flange engagements 152. For example, flange engagement portion 152 may define, but is not limited to, one or more slots for receiving at least a portion of flange 14 of syringe 10. Therefore, the flange engagement portion 152 can limit or suppress the movement of the syringe barrel 11 along the long axis _xb , as described further below.

  Referring now to FIG. 22, for purposes of illustration and not limitation, in some embodiments, the self-injection device 100 may further include a flange adapter 170. The flange adapter 170 may include a recess 171 sized to receive the flange 14 of the syringe 10. The flange adapter 170 is also sized to be received in and engage with the flange engaging portion 152 such that the recess 171 and thus the syringe barrel 11 is substantially aligned with the barrel engaging portion 112. Also, at least one wing element 172 may be provided.

As described above, the base 110 further includes the outer cylinder engaging portion 112. The outer cylinder engaging portion 112 may be fixed at a predetermined position, for example, may be integrated with the rest of the base. Alternatively, as embodied herein, the outer tube engaging portion 112 may be movable, for example, to facilitate removal of the syringe cap. For example, barrel engaging portion 112 may include a syringe engaging element 140 shown in FIG. 10 for purposes of illustration and not limitation. As embodied herein, the syringe engaging element 140 may be sized to receive the barrel 11 of the syringe 10 and may include a barrel engaging gap defining a major axis _xb . The syringe engaging element 140 may also include a cap engaging portion 141 and cover engaging portions 142, 143. The cap engaging portion 141 has a U-shape or other suitable shape defining an opening sized to receive at least a portion of the first end 17 of the outer cylinder 11 proximate the shoulder 12. A notch 144 may be provided. Referring to FIG. 16, as embodied herein, a syringe engaging element 140 can be coupled to a locking mechanism 150 through a slot 136. Accordingly, the syringe engaging element 140 may be longitudinally movable along the slot 136 between the first position and the second position. Accordingly, the cap engaging portion 141 moves relative to the one or more flange engaging portions 152 along the long axis _xb to move the cap 15 away from the outer cylinder 11 as discussed further herein. It may be possible. As embodied herein, a biasing element 24 (e.g., shown in FIG. 19) disposed within a biasing slot 137 engages a syringe engaging element 140 and moves it to a first position. Bias toward position. The biasing element 24 may be configured as, for example, but not limited to, a mechanical spring, or any other suitable biasing element.

Referring now to FIG. 7, for purposes of illustration and not limitation, an exemplary shroud member 120 includes a proximal end 121 and a distal end 122. The shroud member 120 is coupled to the base 110 and may be movable relative to the base 110 along a major axis _xb between a fully extended position and a fully retracted position. For example, Figure 1, in a position fully extended as shown in FIGS. 17 and 18, the distal end portion 122 of the shroud member 120 extends a distance _{D 2} extending from the distal end 111 of the base 110. For example, in the fully retracted position shown in FIG. 19, the distal end portion 122 of the shroud member 120 extends a distance _{D 3} retracted from the distal end 111 of the base 110. Here, as embodied, the distance D ₂ extending is at least a distance D ₁ or more. The distance _{D 3} retracted is first less than distance _{D 1.} As such, for example, as embodied herein, when the shroud member 120 is in the extended position, the shroud 120 at least engages the needle 13 of the syringe 10 with the syringe engaging member 140. Partially cover. Therefore, the shroud member 120 can prevent or suppress the needle from being inadvertently stabbed, and can hide the needle 13 from the user's view. When the shroud member 120 is in the retracted position, the distal end 19 of the needle 13 may be exposed, for example, so that the needle 13 can be inserted into the injection site.

  As embodied herein, shroud member 120 may be biased toward the extended position. 17 to 19, the shroud member 120 may include a biasing engagement member (not shown) that engages the biasing member 23. The biasing member 23 may be configured as, for example, but not limited to, a mechanical spring, or any other suitable biasing element. The distal end of shroud member 120 may include a substantially planar engagement surface 124. The engagement surface 124 may be sized and shaped to engage an injection site, such as a user's skin, during an injection. In some embodiments, engagement surface 124 may include one or more surface features, such as textured ribs or depressions, which may increase friction in the proximity of engagement surface 124. Yes, thus reducing or preventing unwanted slippage of the engagement surface 124 along the injection site. The engagement surface 124 may have a notch 125 therein that is aligned with the needle 13 when the barrel 11 of the syringe 10 is received in the barrel engagement portion 112. Alternatively, the planar engagement surface 124 may have a through hole instead of the notch 125. As another alternative, shroud member 120 may include a tubular portion disposed between proximal end 121 and distal end 122. The tubular portion surrounds the needle 13 when located within the outer tube engagement portion 112 and can further hide the needle 13 from view when the shroud 120 is in the extended position.

  Referring to FIG. 9, the self-injection device 100 may include a cover 160. The cover 160 may include a gripping member 166. The cover 160 is mounted on the base 110 such that the cover 160 is pivotable between an open position (eg, shown in FIGS. 1 and 23) and a closed position (eg, shown in FIGS. 2-6 and 25). It may be butterfly. For example, as shown in FIGS. 1-2, the cover 160 may be connected to the base via a cover receiving hole 139 that receives one or more protrusions 165 of the cover 160. The cover may be opaque to further hide the needle from view or may be transparent so that the contents of the syringe can be viewed.

  Referring to FIG. 1, the cover is also sized to engage the outer cylinder 11 when the cover 160 is in the closed position and prevent or restrain the outer cylinder 11 from separating from the outer cylinder engaging portion 112. One or more protrusions 161 may also be provided. Cover 160 may also include base engaging members 162,163. The base engaging members 162, 163 can engage the cover engaging portions 142, 143 when the cover 160 is rotated to the closed position. For example, as embodied herein, the base engagement members 162, 163 may be configured as one or more protrusions, and the cover engagement portions 142, 143 may be configured as one or more protrusions. It may be configured as one or more ramps formed at mating sizes and locations. In operation, when the cover 160 is rotated toward the closed position, the base engaging members 162 and 163 abut the inclined surfaces of the cover engaging portions 142 and 143 and move along the inclined surfaces. As such, as the base engaging members 162, 163 move further along the inclined plane, the base engaging members 162, 163 move the movable syringe engaging element 140 disclosed herein about a long axis. The distance that can be moved along is increased, thereby moving the syringe engaging member 140 together with the cap engaging portion 141 from the first position to the second position. Further, the base engaging members 162, 163 may include locking members 164, 165. When the cover 160 is in the closed position, the locking members 164 and 165 can abut or lock the cover engaging portions 142 and 143 to fix the cover 160 in the closed position.

23-26, the operation of the self-injection device 100 is shown and described with respect to a kit including a syringe and a self-injection device of the disclosed subject matter for purposes of illustration and not limitation. It is to be understood that the kits disclosed herein may include some or all of the features detailed above. As shown in FIG. 22, a flange adapter 170, if present, can be attached to the syringe flange. Next, as shown in FIGS. 23 and 24, the cap engaging portion 141 is arranged between the shoulder portions 12 of the syringe 10 so as to engage with the end portion 21 of the cap 15, and the syringe 10 is connected to the outer cylinder engaging portion. Position within 112. As discussed herein, when the cover 160 pivots from the open position to the closed position, the base engagement members 162, 163 engage the cover engagement portions 142, 143 and cap the syringe engagement member 140. It is moved from the first position to the second position together with the engaging portion 141. As such, as shown in FIG. 25, when the cover 160 rotates from the open position to the closed position and the syringe engaging member 140 moves, the cap engaging portion 141 moves along the long axis _xb by one. The cap 15 moves away from the outer cylinder 11 with respect to the one or more flange engaging portions 152. However, since the shroud member 120 is biased toward the extended position, the needle 13 remains hidden from view.

As embodied herein, with syringe 10 in self-injection device 100 and cover 160 pivoted to the closed position, a user can perform injection using self-injection device 100. Can be. In operation, the user may position the flat engagement surface 124 of the tip 122 of the shroud member 120 with the needle directly above the injection site and the needle aligned vertically with the engagement surface of the shroud. The self-injection device can be placed over the desired injection site so as to rest on the patient's skin. In this position, _{D 1} is the distance between the tip portion 122 extends a distance _{D 2} extending from the base of the tip portion 111, the distance _{D 2} is at least the tip portion 19 and the base portion of the tip 111 of the needle 13 of the shroud 120 That is all. In this position, the needle has not yet contacted the patient's skin. Further, the shroud member 120 can hide the needle 13 from the user's view. The user can then depress the self-injection device 100 to move the shroud member 120 from a fully extended position to a fully retracted position. In the fully retracted position, the distal end portion 122 of the shroud member 120, as shown in FIG. 26, the distance D ₃ retracted from the base of the tip 111. Therefore, when the user presses the self-injection device 100 against the injection site, the needle 13 moves through the shroud member 120 and is injected into the injection site. The user can then depress plunger 16 and expel beneficial agent through needle 13 to the injection site.

  After the injection, the user can pull the self-injection device 100 away from the injection site and withdraw the needle 13 from the injection site. When removing the self-injection device 100, the biasing member 23 can return the shroud member 120 to the first position or the extended position. Thus, when the device 100 is pulled away from the user, the needle 13 is again hidden by the shroud member 120 and is hidden from the user's view. Furthermore, this configuration can prevent the needle from being inadvertently pierced after use of the syringe 10, particularly if the shroud includes a tubular portion configured to completely surround the needle in the extended position. Shroud member 120 can also hide needle 13 from the user's view. However, in alternative embodiments, the shroud member 120 may be configured to remain locked in the second position until the cover 160 is opened, as described below.

  For example, if desired, the cover 160 may provide frictional engagement between the shroud member 120 and the base 110, for example, an outer cylinder engaging portion, to inhibit movement of the shroud until the cover moves to the open position. May be configured.

  Alternatively, in other embodiments, the proximal end 121 may further include a locking protrusion 126. The locking mechanism 150 is movable between a disengaged position (when the syringe engaging element 140 is in the first position) and an engaged position (when the syringe engaging element 140 is in the second position). There may be. The locking projection 126 may be configured to engage the locking mechanism 150 when the locking mechanism 150 is in the engaged position and the shroud member is in the retracted position. The locking mechanism 150 may be movable to a disengaged position, and is configured to engage and disengage the locking protrusion 126 when the cover 160 rotates from the closed position to the open position with respect to the base. Is also good.

  After use, the cover 160 can be returned to the open position by the gripping member 166. Therefore, by rotating the cover 160 away from the base 110, the locking members 164, 165 can be disengaged from the cover engaging portions 142, 143. As the cover 160 pivots toward the open position, the syringe engaging member 140 can return to the first position. Syringe 10 can be removed from self-injection device 100 and disposed of appropriately. Therefore, the self-injection device 100 can be reused by inserting a new syringe 10.

  The disclosed subject self-injection devices can be used to inject or deliver a corresponding amount or dose of any of a variety of suitable liquid substances. For example, a suitable liquid substance can include any suitable nutritional, pharmaceutical, or biological agent. Suitable liquid substances can include valuable liquids that can include proteins. In some embodiments, beneficial solutions can include TNF inhibitors such as adalimumab, and the like.

  The self-injection device can be made of any suitable medical device material, including but not limited to plastic or other known materials. The device can be formed by any suitable method, such as, but not limited to, injection molding.

  Although the subject matter disclosed herein is described with respect to particular preferred embodiments, those skilled in the art will recognize that various changes and modifications may be made to the disclosed subject matter without departing from the scope thereof. Moreover, individual features of one embodiment of the disclosed subject matter may be discussed herein, or may be shown in drawings of one embodiment and not shown in other embodiments, but not individually. It should be apparent that the features of can be combined with one or more features of another embodiment or features of multiple embodiments.

  In addition to the specific embodiments claimed below, the disclosed subject matter also relates to other embodiments having the dependent features claimed below and any other possible combinations of those disclosed above. As such, the specific features set forth in the dependent claims and the features disclosed above are set forth such that the subject matter disclosed is particularly likely to pertain to other embodiments having any other possible combinations. Certain features can be combined with each other in other ways within the scope of the disclosure. Accordingly, the foregoing description of a specific embodiment of the disclosed subject matter has been presented for purposes of illustration and description. It is not exhaustive, ie, does not limit the disclosure to these disclosed embodiments.

  Those skilled in the art will recognize that various changes and modifications can be made to the disclosed methods and systems without departing from the spirit or scope of the disclosed subject matter. Accordingly, the subject matter of the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Claims (27)

A self-injection device that assists in injecting a beneficial agent from a syringe, wherein the self-injection device comprises:
A base having a proximal end, a distal end, and a syringe-engaging element, wherein the syringe-engaging element defines a cavity having a long axis, and wherein the distal end of the injection needle is a first distance from the distal end of the base. A base disposed between the proximal end and the distal end of the base so as to receive at least a portion of the syringe barrel while extending by a distance of A base configured to move along the long axis between the proximal end and the distal end, wherein the syringe engaging element has a cover engaging portion;
A cover coupled to the base, wherein the cover is rotatable between an open position and a closed position with respect to the base, the cover having a base engaging member protruding therefrom. And
In response to pivoting the cover from the open position to the closed position, the base engaging member is configured to move the syringe engaging element toward the distal end of the base along the long axis. A self-injection device that engages the cover engagement portion. The cover engagement portion is configured as an inclined surface formed at a size and position at which the base engagement member engages,
In response to the cover pivoting toward the closed position, the base engagement member abuts the inclined surface of the cover engagement portion and moves along the same, and the base engagement member is The base engaging member moves the syringe engaging element along the long axis as the syringe engaging element further moves along the inclined surface toward the distal end of the base. 2. The self-injection device of claim 1, wherein the distance that can be taken is increased.   The base engaging member includes a locking member that locks the cover engaging portion when the cover is at the closed position, and includes a locking member that fixes the cover at the closed position. Item 2. The self-injection device according to Item 1.   The self-injection device further comprises a shroud member having a proximal end and a distal end, wherein the proximal end of the shroud member is movably connected to the base, and wherein the shroud member comprises a distal end of the shroud member. Is movable between an extended position that is a distance extended from the distal end of the base and a retracted position that is a distance that the distal end of the shroud member is retracted from the distal end of the base. Item 2. The self-injection device according to Item 1. The base further includes a locking mechanism movable between a disengaged position and an engaged position,
A proximal end of the shroud member includes at least one engagement configured to engage the locking mechanism when the locking mechanism is in the engaged position and the shroud member is in the retracted position. 5. The self-injection device according to claim 4, comprising a stop projection.   The self-injection device according to claim 4, wherein the shroud member is biased toward the extended position.   5. The self-injection device according to claim 4, wherein a tip portion of the shroud member has a flat engagement surface having a notch formed therein.   5. The self-injection device according to claim 4, wherein a distal end of the shroud member has a planar engagement surface having a through hole formed therein.   The self-injection device of claim 4, wherein the shroud member further comprises a tubular portion disposed between a proximal end and a distal end of the shroud member.   A slot for receiving at least a portion of a flange disposed proximate a second end of the syringe barrel, the slot being for restraining movement of the syringe barrel along the long axis. 2. The self-injection device of claim 1, further comprising at least one flange engaging portion that defines: The base comprises a housing;
A cap engagement wherein the syringe engaging element is movable relative to the housing, the syringe engaging element having an opening sized to receive at least a portion of a first end of the syringe barrel; A cap engaging portion positioned to engage an end of a cap proximate a shoulder disposed proximate to the first end of the syringe barrel, the cap engaging portion comprising: The self-injection device according to claim 1, wherein a joint is movable with respect to the housing so as to move the cap away from the syringe barrel.   The self-injection device according to claim 11, wherein the cap engaging portion includes a U-shaped notch.   12. The self-injection of claim 11, wherein the housing comprises a bottom and at least one sidewall extending from the bottom, and wherein the cover is coupled to the housing proximate at least one of the at least one sidewall. Appliances.   14. The self-injection device according to claim 13, wherein the at least one side wall has a round shape.   14. The self-injection device of claim 13, wherein the housing comprises a proximal surface extending from the bottom and disposed perpendicular to the at least one side wall.   16. The self-injection of claim 15, wherein the proximal surface comprises an opening and receives at least a portion of a plunger through the opening when at least a portion of the syringe barrel is positioned within the syringe engaging element. Appliances.   The self-injection device according to claim 1, wherein the cover has at least one protrusion that engages the syringe barrel when the cover is in the closed position.   The self-injection of claim 11, wherein the cap engaging portion is movable relative to at least one flange engaging portion when the cover pivots from the open position to the closed position relative to the base. Appliances.   The self-injection device according to claim 1, wherein the syringe is maintained in an engaged state when the cover moves to the closed position.   The self-injection device according to claim 10, further comprising a flange adapter having a recess for receiving the flange and at least one wing element configured to engage the at least one flange engagement.   6. The locking mechanism according to claim 5, wherein the locking mechanism is movable between the non-engaged position and the engaged position when the cover rotates from the open position to the closed position with respect to the base. The device for self-injection as described.   When the cover pivots from the closed position toward the open position relative to the base, the locking mechanism disengages the at least one locking projection from the non-engaged position such that the locking mechanism disengages the at least one locking projection. 6. The self-injection device of claim 5, wherein the device is movable toward a mating position.   9. The self-injection device of claim 8, wherein the planar engagement surface of the shroud member comprises one or more surface features formed therein for engaging skin at an injection site during an injection.   The self-injection device according to claim 7, wherein the notch comprises a U-shaped notch. An outer cylinder having a first end and a second end and defining a major axis therebetween, a shoulder proximate to the first end, and fluid communication with the outer cylinder; And having a proximal end and a distal end, a needle extending from a first end of the outer cylinder, a flange disposed proximate to a second end of the outer cylinder, and covering the needle; A syringe having a cap disposed at one end near the shoulder, and a plunger movable within the barrel to expel a beneficial agent through the needle;
A kit comprising a self-injection device,
The self-injection device,
A base having a proximal end, a distal end, and a syringe-engaging element, wherein the syringe-engaging element defines a gap, and the distal end of the needle extends a first distance from the distal end of the base. Wherein the cavity is disposed between a proximal end and a distal end of the base so as to receive at least a portion of the outer cylinder when the syringe is engaged. A base configured to move between a portion and the tip, wherein the syringe engaging element has a cover engaging portion;
A cover coupled to the base, wherein the cover is rotatable with respect to the base between an open position and a closed position, wherein the cover has a base engagement member,
With
A kit in which the base engagement member engages with the cover engagement portion in response to rotation of the cover from the open position to the closed position.   The device for self-injection further comprises a shroud member having a proximal end and a distal end, wherein the proximal end of the shroud member is movably connected to the base, and the shroud member is a member of the shroud member. The shroud member is movable between an extended position where the distal end extends from the distal end of the base and a retracted position where the distal end of the shroud member is retracted from the distal end of the base. The kit of claim 25. The base further includes a locking mechanism movable between a disengaged position and an engaged position,
A proximal end of the shroud member includes at least one engagement configured to engage the locking mechanism when the locking mechanism is in the engaged position and the shroud member is in the retracted position. 27. The kit of claim 26 , further comprising a stop.

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