Patent Description:
<CIT> discloses an auto-injector for a medicament prefilled syringe, having a head at one end and fitted with a needle at the other end, the auto-injector incorporating a first device which makes automatic the needle penetration into the user's body and controls a second device which performs the medicament injection. The first device includes: a cylindrical body formed for receiving a syringe and provided at its upper end with a collar forming a seat suitable to bear the head of the syringe, and a sliding tubular element or slider concentric to the body and adapted to slide on a cylindrical surface of the body. One of the body and slider is formed with a bevelled projection and the other of the body and slider is formed with a shoulder. A resilient ring is arranged in such a way that ring prevents the reciprocal movement of body and slider thus maintaining the latter in such a position to cover the entire needle of the syringe. The resilient ring is designed for spreading when a predetermined force exerted on the slider is reached and so allowing reciprocal movement of body and shoulder, the slider reaching a position in which the needle is uncovered and penetrates into the user's body. The slider is fitted with an appendix disposed for releasing a triggering device on the second device when the reciprocal movement is completed. <CIT> discloses an auto-injector for automatically injecting an active agent, comprising a) an elongated casing, b) an injection needle connected to an active agent container, c) a piston shiftable in the active agent container to deliver the active agent, d) a needle protecting tube shiftable into the elongated casing against the force of a spring, e) a locking member in the form of a locking sleeve with at least one locking tongue protruding elastically outwards from the locking sleeve, wherein the locking sleeve is positionable by the needle protecting tube, and wherein when the auto-injector is lifted from a point of injection the needle protecting tube is shifted back into an initial state by a force of the spring and a free end of the at least one locking tongue grips behind an end edge of the needle protecting tube, such that the needle protecting tube is secured against retracting relative to the active agent container and locked in a position in which it substantially surrounds the injection needle. <CIT> discloses a reloadable auto injector for epinephrine injection. The reloadable auto injector has a separate needle insertion and medicine injection drivers wherein needle insertion driver is configured to be re-activated upon reloading. A syringe is movably positioned in a housing between a first position in which the needle is accommodated inside the housing and a second position in which the needle protrudes outside the housing. A plunger rod is normally locked to a plunger rod tube by at least one deflectable locking member. A syringe driver applies a force to the syringe to move the syringe together with plunger rod tube, plunger rod and plunger rod driver from the first position to the second position. In the second position, the locking member is unlocked and releases the plunger rod to thereby activate the plunger rod driver to advance the plunger rod in the syringe for delivering of medicament. A reload handle is connected to the syringe assembly so that user operation of the reload handle retracts the syringe to the first position and simultaneously reload the syringe driver to thereby ready the auto injector for delivering a further dose of medicament. <CIT> discloses a housing part for an auto-injector comprising a shell form body defining inner and outer shell surfaces and comprising a relatively hard or generally incompressible material; an over-coating formed of a relatively softer or more compressible material, the over-coating covering at least part of the outer shell surface of the shell form body; and at least one window defined in the shell form body, wherein the over-coating extends into the at least one window. Also provided is a housing comprising the housing part, and an auto- injector comprising the housing. <CIT> discloses an automatic injection device for a product contained in a container, comprising: - a housing receiving the container, the container being movable between an initial position and an insertion position, - triggering means for initiating the movement of said container from its initial position to its insertion position, said triggering means being in one of a passive state, in which application of a force on said triggering means does not initiate movement of said container, and an active state, in which application of said force on said triggering means does initiate said movement, and - a safety shield movable with respect to said housing between a first position and a second position, movement of said safety shield from its first position to its second position placing said triggering means in its active state, characterized in that said device comprises: an indicator that provides an indication to a user of the device that the safety shield has reached its second position.

The present invention provides an injector according to the appended claims. In one example useful for understanding the invention there is an injector including a housing having a proximal end and a distal end, a shell, a plunger, a needle guard, a first member, and an actuation assembly. The shell may be within the housing and may have a cavity to receive at least a portion of a medicament chamber. The shell may be moveable with respect to the housing from an initial position to an injecting position. The plunger may be moveable with respect to the shell. The needle guard may be moveable between an extended position and a retracted position. The first member may be within the housing and coupled to the housing. The actuation assembly may be coupled to the housing and the shell. The needle guard may move the first member with respect to the housing as the needle guard moves from the extended position to the retracted position. The actuation assembly may move the shell from the initial position to the injecting position when the first member moves with respect to the housing. The actuation assembly may move the plunger with respect to the shell when the shell is in the injecting position.

Proximal movement of the needle guard may move the first member proximally with respect to the housing. The shell may move with respect to the housing in response movement of the needle guard. Movement of the needle guard may trigger the injector. The shell may move distally with respect to the housing when the first member moves proximally with respect to the housing. The first member may include a detent moveable from a first position to a second position. The detent may engage the housing to prevent movement of the first member when the detent is in the first position. The detent may be disengaged from the housing when the detent is in the second position. The needle guard may prevent movement of the detent from the first position to the second position when the needle guard is in the extended position.

In a further example useful for understanding the invention, the injector includes a second member fixed to the housing, the second member including a catch engageable with the shell to prevent movement of the shell with respect to the housing. The second member may at least partially encircle the shell. The shell may include a recess and the catch may be positioned within the recess when the catch is in a first position. The catch may move out of the recess when the first member moves with respect to the housing. The actuation assembly may include a first biasing element operatively associated with the housing and the shell. The first biasing element may move the shell relative to the housing from the initial position to the injecting position when the first member moves with respect to the housing. The actuation assembly may include a second biasing element operatively associated with the shell and the plunger. The second biasing element may move the plunger with respect to the shell when the shell is in the injecting position. The shell may include an engagement member moveable from an engaged position wherein the engagement member prevents movement of the ram to a disengaged position wherein the ram can move with respect to the shell. The engagement member may be in the engaged position when the shell is in the initial position. The engagement member may be in the disengaged position when the shell is in the injecting position.

In a further example useful for understanding the invention, the injector includes a second member fixed to the housing, the second member including a catch engageable with the shell to prevent movement of the shell with respect to the housing. The second member may block movement of the engagement member from the engaged position to the disengaged position when the shell is in the initial position. In a further embodiment, the injector include a syringe and a syringe holder. The syringe holder may include a first end, a second end, a longitudinal axis extending from the first end to the second end, and a sidewall extending from the first end toward the second end. The sidewall may define a receiving area for the syringe. The sidewall may include a sidewall opening such that the syringe can be loaded into the syringe holder from a side of the syringe holder. The syringe may be loaded into the syringe holder without moving axially through a rear opening of the syringe holder. A needle shield may be coupled to the syringe and the syringe may be loaded into the syringe holder without passing the needle shield through the syringe holder The sidewall opening may extend from the first end to the second end. The syringe may include a body defining a medicament chamber, a needle fluidly coupled to the medicament chamber, and a needle shield that receives the needle. The needle shield may have a needle shield diameter. The syringe holder may include an end wall having an end wall opening with an end wall opening diameter that is smaller than the needle shield diameter. The syringe may include a syringe flange at a proximal end of the syringe, wherein a distal end of the syringe engages the end wall and the syringe flange is spaced from the second end of the sidewall when the syringe is coupled to the syringe holder.

In a further example useful for understanding the invention, the injector includes a needle shield remover having a projection positioned between a proximal end of the needle shield and the distal end of the syringe. In a further embodiment, the injector includes a cap coupled to the housing. The needle shield remover may be coupled to the cap such that the needle shield is removed when the cap is decoupled from the housing. The cap may at least temporarily maintain the needle guard in the extended position. Movement of the plunger may expel medicament from the medicament chamber through the needle. The needle guard may be moveable to a lockout position and the needle guard may include a needle guard lock that engages a lockout surface to prevent proximal movement of the needle guard when the needle guard is in the lockout position. The needle guard lock may include a lockout arm that flexes radially outwardly to engage the lockout surface when the needle guard is in the lockout position. In a further embodiment, a collar is coupled to the housing, the collar including the lockout surface. In a further embodiments, a biasing element is coupled to the collar and the needle guard, the biasing element biasing the needle guard toward the extended position.

The following detailed description of embodiments of the auto-insert injector, will be better understood when read in conjunction with the appended drawings of an exemplary embodiment. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. For example, although not expressly stated herein, features of one or more various disclosed embodiments may be incorporated into other of the disclosed embodiments.

Referring to the drawings in detail, wherein like reference numerals indicate like elements throughout, there is shown in <FIG> an injector, generally designated <NUM>, in accordance with an exemplary embodiment of the present invention. In some embodiments, the injector <NUM> is configured to auto-insert a needle into a patient or user in response to an activation.

The injector <NUM> may be configured to inject medicament into a user or patient. The injector <NUM> may be configured to receive a syringe or the injector may include a medicament chamber. The medicament may be for example, but not limited to, diazepam, haloperidol, lorazepam, methotrexate, testosterone, or recombinant human papillomavirus quadrivalent. The injector <NUM> may be configured to deliver medicament subcutaneously or intramuscularly. The injector <NUM> may be configured to insert a needle to a selected insertion depth. The injector <NUM> may include a retractable needle guard and the insertion depth may be independent of the length of travel of the retractable needle guard. The injector <NUM> may include an inner assembly insertable into an outer housing and the inner assembly may be assembled before coupling the outer housing to the inner assembly. The injector <NUM> may move a needle relative to a housing to an insertion depth before delivering medicament through the needle. The injector <NUM> may include a needle shield remover configured to engage a portion of a rear surface of a needle shield. The needle shield remover may be part of the inner assembly. The inner assembly may allow visual confirmation that the needle shield remover is engaged with a rear surface of the needle shield before completing assembly of the injector <NUM>.

Referring to <FIG>, the injector <NUM> may include a housing <NUM>. The housing <NUM> include a cavity to at least partially receive an inner assembly <NUM> (<FIG>). The inner assembly <NUM> may be configured to move a needle relative to the housing <NUM> and discharge medicament from a reservoir out of the needle. One or more alignment features <NUM> (e.g., protrusion or ridge) may be within the internal cavity of the housing <NUM>. The alignment feature <NUM> may align the inner assembly <NUM> relative to the housing <NUM>. In some embodiments, the housing <NUM> has a cylindrical outer shape. In other embodiments, the housing <NUM> has an outer shape configured to prevent the injector <NUM> from rolling when placed on a surface. The injector <NUM> may include a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM> of the housing <NUM>.

Referring to <FIG> and <FIG>, the injector <NUM> may include a cap <NUM> configured to prevent unintended retraction of a needle guard or unintended exposure of the needle (e.g., during manufacture, transportation, or prior to an intended use). The cap <NUM> may be detachably coupled to the housing <NUM> or a collar <NUM> (<FIG>). The cap <NUM> may be decoupled from the housing <NUM> or collar <NUM> (e.g., by pulling, pushing, or twisting the cap <NUM> relative to the housing <NUM> or collar <NUM>). At least one of the cap <NUM> and the collar <NUM> may include a recess or thread <NUM> to receive a protrusion or mating thread <NUM> on the other of the cap <NUM> and the collar <NUM>. The cap <NUM> may be shaped and dimensioned to prevent the injector <NUM> from rolling when the cap is attached to the injector and the injector is placed on a surface. The collar <NUM> may include a collar protrusion <NUM> (<FIG>) configured to be received by a second aperture <NUM> on the housing <NUM> (e.g., via snap fit), thereby fixing the collar <NUM> to the housing <NUM> (<FIG>). The cap <NUM> may include a receiver <NUM>. The receiver <NUM> may be configured to couple to a needle shield remover, as explained in greater detail below.

Referring to <FIG>, the injector <NUM> may include an inner assembly <NUM>. The inner assembly <NUM> may be configured to move a syringe relative to the housing <NUM> and to deliver medicament from the syringe to a user or patient. The inner assembly <NUM> may include a first member <NUM>, a second member <NUM>, and a shell <NUM>. The inner assembly <NUM> may include a ram <NUM> and an actuation assembly configured to move at least one of the shell <NUM> and the ram <NUM> with respect to the housing <NUM>. The first member <NUM>, second member <NUM>, shell <NUM>, and ram <NUM> may nest within each other within the housing. Some parts of the inner assembly <NUM> may be fixed to the housing <NUM> while other parts are moveable relative to the housing <NUM>. The second member <NUM> may be fixed relative to the housing <NUM> and the first member <NUM> may be moveable relative to the second member <NUM> and the housing <NUM>.

Referring to <FIG>, <FIG>, and <FIG>, in some embodiments, the second member <NUM> is fixed to the housing <NUM> by a protrusion <NUM> (<FIG>) positioned in an aperture <NUM> (<FIG>) of the housing <NUM>. In other embodiments, the second member <NUM> includes an aperture configured to receive a protrusion on the housing <NUM>. The protrusion <NUM> may be coupled to the housing <NUM> via a snap fit. In other embodiments, the second member <NUM> is fixed to the housing <NUM> via adhesive, welding, or fastener.

Referring to <FIG>, <FIG>, and <FIG>, the second member <NUM> may include a first arm <NUM> or catch. The first arm <NUM> may engage and prevent movement of the shell <NUM> relative to the housing <NUM>. The first arm <NUM> may be configured to move from a first position (<FIG>) to a second position (<FIG>). The first arm <NUM> may deflect radially outwardly as the arm moves from the first position to the second position. In some embodiments, the first arm <NUM> is biased toward the second position but a first member <NUM> blocks movement of the first arm <NUM> until the injector <NUM> is activated. In other embodiments, the first arm <NUM> is at rest in the first position but movement of the shell <NUM> relative to the housing <NUM> forces the first arm <NUM> from the first position to the second position.

Referring to <FIG>, the first member <NUM> may be configured to at least partially receive the second member <NUM>. The first arm <NUM> of the second member <NUM> may be in the first position when the second member <NUM> is received by the first member <NUM>. The first member <NUM> may at least partially surround the second member <NUM> such that the first member <NUM> blocks movement of the first arm <NUM>. The first member <NUM> may be moveable (e.g., axially translatable, rotatable) relative to the housing <NUM> or second member <NUM>. The first member <NUM> may include a recess or opening <NUM>. The first arm <NUM> may move from the first position to the second position when the first arm <NUM> is aligned with the opening <NUM>. The opening <NUM> may be aligned with the first arm <NUM> when the first member <NUM> is moved relative to the second member <NUM>. The second member <NUM> may remain fixed relative to the housing <NUM> as the first member <NUM> moves relative to the second member <NUM>.

Referring to <FIG> and <FIG>, a safety <NUM> may be positioned in the opening <NUM> when the injector <NUM> is in a safe state. The safety <NUM> may extend through an opening in the housing <NUM>. The safety <NUM> may engage a sidewall of the opening in the housing <NUM> such that the safety <NUM> is prevented from moving axially along the axis <NUM>. The safety <NUM> may be detachably coupled to the housing <NUM>. The safety <NUM> may prevent axial movement of the first member <NUM>. The safety <NUM> may be manually removed from the housing <NUM> such that the injector <NUM> may be activated as described herein. In some embodiments, the safety <NUM> is coupled to the housing <NUM> during manufacturing and is removed once the injector <NUM> is assembled. The safety <NUM> may be removed prior to the injector <NUM> being provided to a user. In other embodiments, the safety <NUM> is removed by a user prior to using the injector <NUM>.

Referring to <FIG>, and <FIG>, the first member <NUM> may include a detent <NUM>. The detent <NUM> may be moveable relative to the first member <NUM> from a first position (e.g., relaxed position) to a second position (e.g., a radially flexed position). The detent <NUM> may include a cantilevered arm extending from the first member <NUM>. The detent <NUM> may be configured to engage a sidewall of a first detent opening <NUM> or second detent opening <NUM> in the housing <NUM> (<FIG>) as explained in greater detail below.

Referring to <FIG> and <FIG>, the shell <NUM> may be configured to be coupled to a syringe carrier. The shell <NUM> may be moveable with respect to the housing <NUM> from an initial position (<FIG>) to an injecting position (<FIG>). The shell <NUM> may be positioned with the housing <NUM>. The second member <NUM> may at least partially encircle the shell <NUM>. The shell <NUM> may include a first recess <NUM> on an outer surface thereof. The first recess <NUM> may extend through a sidewall of the shell <NUM>. The first recess <NUM> may be configured to receive a portion of the first arm <NUM> of the second member <NUM> to at least temporarily fix the shell <NUM> relative to the second member <NUM>. The first arm <NUM> may be positioned within the recess <NUM> when the first arm <NUM> is in the first position.

Still referring to <FIG> and <FIG>, the shell <NUM> may be moveable (e.g., axially translatable, rotatable) relative to the housing <NUM> or second member <NUM>. The first arm <NUM> may engage a sidewall of the first recess <NUM> to prevent the shell <NUM> from moving relative to the housing <NUM>. At least one the recess <NUM> and the first arm <NUM> may have a chamfered edge such that axial movement of the shell <NUM> causes radial movement of the first arm <NUM>.

Still referring to <FIG> and <FIG>, the shell <NUM> may include an inner recess <NUM> or cavity configured to at least partially receive a ram <NUM> (<FIG>). In some embodiments, the inner recess <NUM> is configured to receive a syringe <NUM>. In other embodiments, the inner recess <NUM> defines a medicament chamber. The shell <NUM> may include an engagement member <NUM> configured to at least temporarily hold the ram <NUM> in a pre-firing position. The shell <NUM> may include a plurality of engagement members <NUM> spaced circumferentially about the perimeter of the shell <NUM>. The engagement member <NUM> may include a flexible arm that at least temporarily blocks movement of the ram <NUM>. The engagement member <NUM> may be biased radially outwardly. The engagement member <NUM> may be moveable between an engaged position (<FIG>) wherein the engagement member prevents movement of the ram <NUM> and a disengaged position (<FIG>) wherein the ram <NUM> can move with respect to the shell <NUM>. The second member <NUM> may prevent movement of the engagement member <NUM> between the engaged position and the disengaged position. The engagement member <NUM> may be in the engaged position when the shell <NUM> is in the initial position. The engagement member <NUM> may be in the disengaged position when the shell <NUM> is in the injecting position.

Referring to <FIG> and <FIG>, the ram <NUM> may include a rim <NUM> configured to engage the engagement member <NUM> when the injector <NUM> is in the pre-firing configuration (<FIG>). The ram <NUM> may be configured to engage a plunger <NUM>. The plunger <NUM> may move relative to the shell <NUM> as the ram <NUM> moves relative to the shell <NUM> to force medicament out of a medicament chamber (e.g., in a prefilled syringe), through a needle <NUM>, and into a patient or user. The rim <NUM> may have a larger diameter than the internal diameter of the medicament chamber such that the rim <NUM> cannot enter the medicament chamber. The rim <NUM> of the ram <NUM> may be spaced from the flange <NUM> of the syringe <NUM> when the plunger <NUM> is at the end of the medicament chamber.

Referring to <FIG> and <FIG>, the injector <NUM> may include an actuation assembly configured to move the shell <NUM> from the initial position to the injecting position. The actuation assembly may be coupled to the housing <NUM> and the shell <NUM>. The actuation assembly may be operatively associated with the housing <NUM> and the shell <NUM>. The actuation assembly may include a first biasing element <NUM>. The first biasing element <NUM> may be operatively associated with the housing <NUM> and the shell <NUM>. The first biasing element <NUM> may urge the shell <NUM> toward the distal end <NUM> of the injector <NUM>.

Still referring to <FIG>, the actuation assembly may include a second biasing element <NUM>. The actuation assembly may include first biasing element <NUM> and second biasing element <NUM>. The second biasing element <NUM> may be positioned within the inner recess <NUM> of shell <NUM>. The second biasing element <NUM> may be operatively associated with the shell <NUM> and the ram <NUM>. The second biasing element <NUM> may engage the rim <NUM> of the ram <NUM> and an end of the shell <NUM> such that the ram <NUM> is biased toward the distal end <NUM> of the injector <NUM>. In some embodiments, the second biasing element <NUM> does not move the ram <NUM> until the shell <NUM> is in the injecting position. The actuation assembly may cause movement of the plunger <NUM> with respect to the shell <NUM> when the shell <NUM> is in the injecting position.

Referring to <FIG>, the inner recess <NUM> of the shell <NUM> may include a first portion 66a and a second portion 66b. The second portion 66b may be proximal to the first portion 66a. The first portion 66a may be configured to receive a portion of the ram <NUM> and the rim <NUM>. The second portion 66b may be configured to receive a proximal end of the ram <NUM> and a second biasing element <NUM>. The second portion 66b may have a smaller diameter than the first portion 66a. The first portion 66a may have a greater axial length than the second portion 66b.

Referring to <FIG>, <FIG>, and <FIG>, the injector <NUM> may include a needle guard <NUM>. The needle guard <NUM> may surround the needle <NUM> when the injector <NUM> is not in use. The needle guard <NUM> may be moveable relative to the housing <NUM> from an extended position (<FIG>) to a retracted position (<FIG>). The needle guard <NUM> may be configured to be moved by a user when a distal end of the needle guard <NUM> is positioned against an injection site (e.g., against a user's skin) and a force is applied to the distal end of the injector <NUM> such that the needle guard <NUM> moves proximally relative to the housing <NUM>. The needle guard <NUM> may include a base <NUM> (<FIG>). At least a portion of the base <NUM> may extend from the housing <NUM> when the injector <NUM> is in the pre-firing configuration. The needle guard <NUM> may include a leg <NUM> extending from the base <NUM>. The leg <NUM> may include a needle guard protrusion <NUM> configured to engage the detent <NUM> of the first member <NUM>, as explained in greater detail below. The leg <NUM> may include an engagement surface <NUM> configured to engage the first member <NUM>. The engagement surface <NUM> may be at a proximal end of the leg <NUM>. The leg <NUM> of the needle guard <NUM> may extend through an opening <NUM> in a rim <NUM> (<FIG>) of the shell <NUM>. The rim <NUM> may maintain alignment of the leg <NUM>. The rim <NUM> may prevent undesired flexing of the leg <NUM> of the needle guard <NUM>.

Referring to <FIG>, the needle guard <NUM> may include a limiter <NUM> configured to engage a protrusion or recess on the housing <NUM> or collar <NUM> to limit distal movement of the needle guard <NUM> relative to the housing <NUM> after the injector <NUM> has been fired. The needle guard <NUM> may include a cap engagement feature <NUM> (<FIG>) configured to engage a feature (e.g., a thread or another protrusion) on the cap <NUM> to prevent unintended movement of the needle guard <NUM>. The needle guard <NUM> may be axially fixed relative to the housing <NUM> when the cap <NUM> is coupled to the housing <NUM> and needle guard <NUM>. The needle guard <NUM> may include an opening <NUM> configured to allow the needle <NUM> to pass therethrough when the injector <NUM> is fired. The needle guard <NUM> may include a lockout arm <NUM> (<FIG>) configured to be positioned in a lockout opening <NUM> in the collar <NUM> (<FIG>) after the injector <NUM> has been fired, as explained in greater detail below.

Referring to <FIG>, the injector <NUM> may include a syringe <NUM> (e.g., a pre-filled syringe). The syringe <NUM> may include a body <NUM> defining a medicament chamber and a neck <NUM> adjacent the body <NUM>. The body <NUM> may have a first diameter and the neck <NUM> may have a second diameter. The first diameter may be larger than the second diameter. The needle <NUM> may be coupled to the neck <NUM>. The needle <NUM> may be in fluid communication with the medicament chamber. The plunger <NUM> may be positioned within the medicament chamber. The plunger <NUM> may move relative to the medicament chamber to eject medicament from the medicament chamber out through the needle <NUM>. The syringe <NUM> may include a syringe flange <NUM>. The syringe flange <NUM> may have a larger diameter than the body <NUM>.

Referring to <FIG>, the syringe <NUM> may be positioned in a syringe holder <NUM>. The syringe holder <NUM> may include a c-shape or a partial cylinder shape such that the syringe <NUM> can be loaded from a side of the syringe holder <NUM>. The syringe holder <NUM> may include a first end <NUM> and a second end <NUM>. A sidewall <NUM> may extend from the first end <NUM> to the second end <NUM>. The sidewall <NUM> may define a receiving area for the syringe <NUM>. The sidewall <NUM> may include an opening extending from the first end <NUM> toward the second end <NUM>. The sidewall opening may extend from the first end <NUM> to the second end <NUM>. The syringe <NUM> may be moved through the sidewall opening such that the syringe <NUM> may be loaded into the syringe holder <NUM> from a side of the syringe holder <NUM>. The syringe <NUM> may be loaded into the syringe holder <NUM> without moving the syringe <NUM> axially through a rear opening of the syringe holder <NUM>. The syringe <NUM> may be loaded into the syringe holder <NUM> without passing the needle shield <NUM> through the syringe holder <NUM>. In some embodiments, the syringe <NUM> is snap fit into the syringe holder <NUM>. In some embodiments, the sidewall <NUM> is flexible such that the sidewall <NUM> resiliently deforms as the syringe <NUM> moves through the sidewall opening.

Still referring to <FIG>, the syringe holder <NUM> may include an end wall <NUM> configured to engage an end of the body <NUM> of the syringe <NUM> adjacent the neck <NUM>. The end wall <NUM> may extend radially inward from the sidewall <NUM> of the syringe holder <NUM>. The end wall <NUM> may limit or prevent movement of the syringe <NUM> relative to the syringe holder <NUM> when the injector <NUM> is fired. The end wall <NUM> may include an end wall opening <NUM> configured to receive the neck <NUM> of the syringe <NUM>. The size of the end wall opening <NUM> may be selected such that a portion of the end wall <NUM> contacts the lower portion of the syringe <NUM>. The end wall opening <NUM> may include an opening circumscribing an arc of at least <NUM> degrees. The end wall opening <NUM> may include an arcuate portion <NUM> (<FIG>) having a radius of about <NUM> inches (<NUM>), about <NUM> inches (<NUM>), about <NUM> inches (<NUM>), about <NUM> inches (<NUM>), about <NUM> inches (<NUM>), or about <NUM> inches (<NUM>). The end wall opening <NUM> may include a straight portion <NUM> that is tangent to the arcuate portion <NUM>. The neck <NUM> of the syringe <NUM> may be engaged by the arcuate portion <NUM> and the straight portion <NUM> when the syringe <NUM> is within the syringe holder <NUM>. The end wall opening <NUM> may include a chamfered edge <NUM>. The chamfered edge <NUM> may provide a lead in to make it easier for a user or manufacturer to load the neck of the syringe <NUM> into the end wall opening <NUM>. The end wall <NUM> may be rigid.

Still referring to <FIG>, the syringe holder <NUM> may include syringe holder arms <NUM>. The syringe holder arms <NUM> may include a lip <NUM> configured to retain the syringe <NUM>. The syringe flange <NUM> may be positioned between the lip <NUM> and the second end <NUM> of the syringe holder <NUM>. The syringe flange <NUM> may be spaced from the second end <NUM> of the syringe holder <NUM> when the syringe <NUM> is coupled to the syringe holder <NUM>. Spacing the syringe flange <NUM> from the second end <NUM> of the syringe holder <NUM> may reduce or eliminate any impact of the syringe flange <NUM> on the syringe holder <NUM> to reduce or eliminate breaking the syringe <NUM>. The syringe holder <NUM> may retain the syringe <NUM> even if the syringe <NUM> breaks. The syringe holder <NUM> may include a fastener <NUM> configured to engage a ridge <NUM> (<FIG> and <FIG>) on the shell <NUM> to fix the syringe holder <NUM> relative to the shell <NUM>. The fastener <NUM> may be snap fit into the ridge <NUM>. The arms <NUM> may include the fastener <NUM> to engage the ridge <NUM> on the shell <NUM> and the lip <NUM> to engage the syringe flange <NUM>.

Referring to <FIG>, a needle shield <NUM> may cover the needle <NUM> when the injector <NUM> is in the pre-fired configuration. The needle shield <NUM> may have an outer diameter greater than the diameter of the end wall opening <NUM> on syringe holder <NUM> (<FIG>). The needle shield <NUM> may have an outer diameter that is equal to or greater than the diameter of the syringe body <NUM>. The end wall opening <NUM> may have a diameter that is smaller than an outer diameter of body <NUM>. The diameter of the end wall opening <NUM> may be smaller than an outer diameter of the needle shield <NUM>.

Existing syringe holders may include a tube shape wherein the syringe and needle shield are moved axially through an opening in one end of the syringe holder. The needle shields used with existing end loaded syringe holders must be smaller in diameter than the syringe because the needle shield must pass through the opening of the syringe holder.

In contrast, the syringe holder <NUM> can be used with a needle shield <NUM> having a larger diameter than syringe <NUM> because the needle shield <NUM> does not pass through the syringe holder <NUM> or end wall opening <NUM> as the syringe <NUM> is loaded from the side and into the syringe holder <NUM>. The syringe <NUM> may be snap fit into the syringe holder <NUM>.

Referring to <FIG>, the injector <NUM> may include a needle shield remover <NUM>. The needle shield remover <NUM> may have a c-shape or a partial cylinder shape such that the needle shield <NUM> can be loaded from the side of the needle shield remover <NUM>. The needle shield <NUM> may be snap fit into the needle shield remover <NUM>. The needle shield remover <NUM> may include a sidewall <NUM> defining a receiving area for the needle shield <NUM>. The sidewall may include a sidewall opening such that the needle shield can be loaded from a side through the sidewall opening. The sidewall <NUM> may include a neck <NUM>. The neck <NUM> may snap fit over the needle shield <NUM> when the needle shield <NUM> is loaded into the needle shield remover <NUM>. The syringe <NUM> and the needle shield <NUM> may be simultaneously loaded into the syringe holder <NUM> and the needle shield remover <NUM>. The syringe <NUM> and the needle shield <NUM> may be simultaneously side loaded into the syringe holder <NUM> and the needle shield remover <NUM>.

Still referring to <FIG>, the needle shield remover <NUM> may include a circumferential collar <NUM> at a distal end thereof. An end of the needle shield <NUM> may be loaded into the circumferential collar <NUM> and there may be some relative rotation between the needle shield <NUM> and the needle shield remover <NUM> as the needle shield <NUM> is loaded into the needle shield remover <NUM>. In some embodiments, the distal end of the needle shield <NUM> is loaded into the needle shield remover <NUM> before the proximal end of the needle shield <NUM> is loaded into the needle shield remover <NUM>. The thickness of the sidewall <NUM> or other features of the needle shield remover <NUM> may be selected such that the needle shield remover <NUM> can receive different size needle shields <NUM> without changing the outer dimensions of the needle shield remover <NUM>.

Still referring to <FIG>, the needle shield remover <NUM> may include a remover arm <NUM>. The remover arm <NUM> may be configured to engage a proximal end of the needle shield <NUM>. The remover arm <NUM> may include a projection opening <NUM> having a diameter that is smaller than a diameter of at least one of the needle shield <NUM> and the syringe <NUM>. The remover arm <NUM> may be configured to engage about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, or about <NUM>% of the surface area of the proximal end of the needle shield <NUM>. The remover arm <NUM> and the end wall <NUM> may be positioned between an end (e.g., a proximal end) of the needle shield <NUM> and the end (e.g., a distal end) of the syringe <NUM> adjacent the neck <NUM> (<FIG>).

Referring to <FIG> and <FIG>, the needle shield remover <NUM> may include a remover arm <NUM> configured to engage the cap <NUM>. The remover arm <NUM> may be configured to be snap fit into the receiver <NUM> on the cap <NUM> (<FIG> and <FIG>). The remover arm <NUM> may be a flexible cantilevered beam having a protrusion on an end thereof. The protrusion may be configured to engage a ledge on the receiver <NUM> of the cap <NUM> such that the needle shield remover <NUM> is fixed relative to the cap <NUM>. In some embodiments, the needle shield <NUM> may be coupled to the needle shield remover <NUM> before the needle shield remover <NUM> is coupled to the cap <NUM>. In other embodiments, the needle shield <NUM> is coupled to the cap <NUM> before the needle shield <NUM> is coupled to the needle shield remover <NUM>. In some embodiments, the needle shield <NUM> is coupled to the needle shield remover <NUM> before the syringe <NUM> is coupled to the syringe holder <NUM>.

Referring to <FIG>, in some embodiments, the injector <NUM> is provided to a user in a pre-firing condition. In other embodiments, the injector <NUM> is provided in a safe configuration and a user may move the injector <NUM> to the pre-firing configuration by removing the safety <NUM>. The cap <NUM> may be removed by pulling or twisting the cap <NUM> relative to the housing <NUM> such that the cap <NUM> is decoupled from the housing <NUM>. The needle shield <NUM> may decoupled from the needle <NUM> and the syringe <NUM> when the cap <NUM> is removed because the needle shield remover <NUM> is coupled to the cap <NUM>. The needle guard <NUM> may be moveable relative to the housing <NUM> when the cap <NUM> is removed from the housing <NUM>.

Referring to <FIG>, the needle guard protrusion <NUM> on the leg <NUM> of the needle guard <NUM> may be positioned adjacent the detent <NUM> of the first member <NUM> when the injector <NUM> is in the pre-firing configuration and the needle guard <NUM> is in the extended position (<FIG>). The detent <NUM> may be in the first position when the injector is in the pre-firing configuration. The needle guard protrusion <NUM> may prevent radial movement of the detent <NUM> from the first detent position to the second detent position when the needle guard <NUM> is in the extended position. The detent <NUM> may engage the housing <NUM> (e.g., a sidewall of the first detent opening <NUM>) to prevent movement of the first member <NUM> when the detent <NUM> is in the first position. The detent <NUM> may be disengaged from (e.g., flexed radially inwardly) the housing <NUM> when the detent <NUM> is in the second position.

Referring to <FIG>, the engagement surface <NUM> of the leg <NUM> may contact a ledge <NUM> of the first member <NUM> as a user pushes the distal end of the needle guard <NUM> against an injection site and the needle guard <NUM> moves relative to the housing <NUM> from the extended position toward the retracted position. In some embodiments, the user sets a triggering sequence into motion by moving the needle guard <NUM> relative to the housing <NUM>. In some embodiments, the needle guard <NUM> is the trigger that activates the injector <NUM>. In some embodiments, movement of the needle guard <NUM> triggers the injector <NUM> to deliver a dose of medicament to a user. The needle guard protrusion <NUM> may move along a length of the detent <NUM> of the first member <NUM> as the needle guard <NUM> moves relative to the housing <NUM>. The needle guard protrusion <NUM> may no longer block movement of the detent <NUM> when the engagement surface <NUM> contacts the ledge <NUM> such that the detent <NUM> can move from the first position to the second position.

Referring to <FIG> the needle guard <NUM> may move the second member <NUM> as the needle guard <NUM> continues to move proximally after the engagement surface <NUM> contacts the engagement surface <NUM>. Proximal movement of the needle guard <NUM> may move the second member <NUM> proximally. The detent <NUM> of the first member <NUM> may move from the first detent opening <NUM> to the second detent opening <NUM> as the second member <NUM> moves proximally relative to the housing <NUM>. The detent <NUM> may be moveable between a first position, a second position, and a third position. The detent <NUM> may be within the first detent opening <NUM> in the first position. The detent may be removed from the first detent opening <NUM> in the second position. The detent <NUM> may be within the second detent opening <NUM> in the third position. The first arm <NUM> of the second member <NUM> may be aligned with the opening <NUM> of the first member <NUM> when the first member <NUM> is moved proximally relative to the housing <NUM>. The first arm <NUM> may move out of the first recess <NUM> of the shell <NUM> when the opening <NUM> is aligned with the first arm <NUM>.

Referring to <FIG>, the first biasing element <NUM> may move the shell <NUM> when the first arm <NUM> disengages from the first recess <NUM> of the shell <NUM>. The first biasing element <NUM> may move the shell <NUM> distally. The first biasing element may move the shell <NUM> relative to the housing <NUM> from the initial position to the injecting position when the first member <NUM> moves with respect to the housing <NUM>. Proximal movement of the needle guard <NUM> and the first member <NUM> may cause distal movement of the shell <NUM>. The shell <NUM>, ram <NUM>, syringe <NUM>, and syringe holder <NUM> may move distally relative to the housing <NUM> as the first biasing element <NUM> moves the shell <NUM>. The needle <NUM> may extend through the opening <NUM> of the needle guard <NUM> as the shell <NUM> moves to the injecting position.

Referring to <FIG>, the injector <NUM> may have an insertion depth defined by the length of the needle <NUM> that extends through the opening <NUM> of the needle guard <NUM>. In some embodiments, the insertion depth of the needle <NUM> is about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. In some embodiments, the insertion depth of the needle <NUM> is about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>. In some embodiments, the needle guard is configured to travel about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. In one embodiment, the needle may extend approximately <NUM> to about <NUM> from the distal end of the needle guard <NUM> in response to travel of the needle guard of approximately <NUM> to about <NUM> or about <NUM> to about <NUM>. The insertion depth may be independent of the length of travel of the needle guard <NUM>. The shell <NUM> may move distally until the end wall <NUM> on the syringe holder <NUM> engages a rim <NUM> of the collar <NUM> (<FIG>). The shell <NUM> may be in the injecting position when the syringe holder <NUM> engages the rim <NUM> of the collar. In some embodiments, the position of the ram <NUM> relative to the syringe <NUM> is fixed such that no medicament is ejected as the shell <NUM> moves toward the distal end of the injector <NUM>. In other embodiments, the ram <NUM> may begin to move relative to the syringe <NUM> prior to the syringe holder <NUM> engaging the rim <NUM>.

Referring to <FIG>, the engagement member <NUM> of the shell <NUM> may be positioned distally of the second member <NUM> when the shell <NUM> is in the injecting position. The engagement member <NUM> may move radially outwardly when the engagement member <NUM> moves beyond the second member <NUM>. The movement of the engagement member <NUM> may disengage the engagement member <NUM> from the rim <NUM> of the ram <NUM>. The second biasing element <NUM> may move the ram <NUM> toward the distal end of the injector <NUM> when the rim <NUM> is no longer engages engagement member <NUM>. The engagement member <NUM> may be moveable from a restrained configuration to an expanded configuration. The engagement member <NUM> may be in the restrained configuration when the engagement member <NUM> is within a recess defined by the second member <NUM>. The engagement member <NUM> may move radially outwardly to the expanded configuration when the engagement member <NUM> clears a distal end <NUM> of the second member <NUM> and the engagement member <NUM> is no longer confined by the second member <NUM>. The engagement member <NUM> may not be in contact with the rim <NUM> or may allow distal movement of the ram <NUM> when the engagement member <NUM> is in the expanded configuration. In some embodiments, the second biasing element <NUM> does not begin to expand until the shell <NUM> is in the injecting position.

Referring to <FIG>, the second biasing element <NUM> may apply a force to the rim <NUM> of the ram <NUM> to move the ram distally. The second biasing element <NUM> may move the ram <NUM> when the engagement member <NUM> of the shell <NUM> is in the expanded configuration. The ram <NUM> may move the plunger <NUM> to dispense medicament from the syringe <NUM>, through the needle <NUM> and into the user or patient. In some embodiments, the ram <NUM> is spaced from the plunger <NUM> prior to movement of the ram <NUM>. In other embodiments, the ram <NUM> is associated with (e.g., in contact or close proximity with) the plunger <NUM> prior to movement of the ram <NUM>. The ram <NUM> may move the plunger to an end of the syringe <NUM> to dispense all, a majority of, or a portion of the medicament from the syringe <NUM>.

Referring to <FIG> and <FIG>, a third biasing element <NUM> may be positioned within the needle guard <NUM>. The third biasing element <NUM> may be operatively associated with the needle guard <NUM> and the collar <NUM>. The third biasing element <NUM> may bias the needle guard <NUM> toward the extended position. The third biasing element <NUM> may compress as the needle guard <NUM> is moved proximally relative to the housing <NUM>. The needle guard <NUM> may be configured to axially translate about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM> relative to the housing <NUM>. The needle <NUM> may still be within the recess defined by the needle guard <NUM> when the needle guard <NUM> is initially moved out of the extended configuration (<FIG>). An end of the needle <NUM> may be exposed when the needle guard <NUM> is moved to the retracted position (<FIG>). The third biasing element <NUM> may bias the needle guard <NUM> toward the extended position. In some embodiments, travel of the syringe <NUM> or syringe carrier <NUM> is not impeded or cushioned by the third biasing element <NUM>.

Referring to <FIG> and <FIG>, the injector <NUM> may be removed from the injection site after the medicament has been dispensed from the syringe <NUM>. The needle guard <NUM> may be movable to a lockout position after the injector <NUM> has been activated and is removed from the injection site. The third biasing element <NUM> may move the needle guard <NUM> to the extended lockout position when the needle guard is no longer in contact with the injection site or when the needle guard <NUM> is no longer being pressed against the injection site. The third biasing element <NUM> may move the needle guard <NUM> distally relative to the housing <NUM>. The needle guard <NUM> may extend away from the housing <NUM> a greater distance when the needle guard is in the lock out position than when the injector is in the pre-firing, extended position. The needle guard <NUM> may include a lockout arm <NUM> configured to lock the needle guard <NUM> in the lockout position. The lockout arm <NUM> may prevent proximal movement of the needle guard <NUM> when the needle guard <NUM> is in the lockout position. The lockout arm <NUM> may be biased to flex radially outwardly. The lockout arm <NUM> may flex radially outwardly such that the lockout arm <NUM> is positioned in a lockout opening <NUM> of the collar <NUM> (<FIG>) as the needle guard <NUM> moves to the lockout position. The injector <NUM> may be in a lockout configuration when the lockout arm <NUM> is within the lockout opening <NUM>. The lockout arm <NUM> may be configured to contact a lockout surface or sidewall of the lockout opening <NUM> such that the needle guard <NUM> cannot move proximally relative to the housing <NUM> when the injector <NUM> is in the lockout configuration.

Referring to <FIG>, there is shown a second embodiment of the first member <NUM>. The first member <NUM> may be similar to the first embodiment of the first member <NUM> except that the detent <NUM> of first member <NUM> may engage a recess <NUM> in the shell <NUM> when the shell <NUM> is in the initial position. The needle guard protrusion <NUM> of the needle guard may engage detent <NUM> as the needle guard <NUM> moves with respect to the housing <NUM>. The needle guard protrusion <NUM> may force the detent <NUM> to flex radially outwardly as the needle guard <NUM> moves proximally relative to the housing <NUM>. The detent <NUM> may disengage from the shell recess <NUM> when the detent <NUM> flexes radially outwardly. The needle guard <NUM> may move the first member <NUM> proximally relative to the shell <NUM> and the second member <NUM>. The opening <NUM> may be aligned with the first arm <NUM> when the needle guard <NUM> moves the first member <NUM> relative to the housing <NUM> such that the injector <NUM> may move the shell <NUM> to the injecting position and deliver a dose of medicament as previously described.

It will be appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventive concepts thereof. It is understood, therefore, that this invention is not limited to the exemplary embodiments shown and described, but it is intended to cover modifications within the scope of the present invention as defined by the claims. For example, specific features of the exemplary embodiments may or may not be part of the claimed invention and various features of the disclosed embodiments may be combined. The words "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the injector. Unless specifically set forth herein, the terms "a", "an" and "the" are not limited to one element but instead should be read as meaning "at least one".

It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

Claim 1:
An injector comprising:
a housing (<NUM>) having a proximal end and a distal end;
a shell (<NUM>) within the housing (<NUM>) and having a cavity to receive at least a portion of a medicament chamber, the shell (<NUM>) moveable with respect to the housing from an initial position to an injecting position;
a plunger (<NUM>) moveable with respect to the shell;
a needle guard (<NUM>) moveable between an extended position and a retracted position;
a first member (<NUM>) within the housing (<NUM>); and
an actuation assembly coupled to the housing and the shell (<NUM>);
wherein the first member (<NUM>) includes a detent (<NUM>) moveable from a first position to a second position, wherein the detent (<NUM>) engages the housing (<NUM>) to prevent movement of the first member when the detent (<NUM>) is in the first position and wherein the detent (<NUM>) is disengaged from the housing (<NUM>) when the detent (<NUM>) is in the second position;
wherein the needle guard (<NUM>) prevents movement of the detent from the first position to the second position when the needle guard is in the extended position and wherein the needle guard moves the first member (<NUM>) with respect to the housing as the needle guard moves from the extended position to the retracted position;
wherein the actuation assembly includes a first biasing element (<NUM>) operatively associated with the housing and the shell, wherein the first biasing element (<NUM>) moves the shell (<NUM>) relative to the housing (<NUM>) from the initial position to the injecting position when the first member (<NUM>) moves with respect to the housing (<NUM>); and
wherein the actuation assembly includes a second biasing element (<NUM>) operatively associated with the shell (<NUM>) and the plunger (<NUM>), wherein the second biasing element (<NUM>) moves the plunger (<NUM>) with respect to the shell (<NUM>) when the shell (<NUM>) is in the injecting position.