Patent Description:
Injection devices have recently become increasingly popular for single dose or multi- dose, at home self-administration. (see <CIT>).

These devices include both auto-injection devices and pre-filled syringe devices, and are often designed to accomplish two basic objectives: convenience of drug delivery in an outpatient or at home setting, and/or automation of drug delivery in an outpatient or at-home setting.

Injectable medications are required for a number of varying illnesses and diseases. A number of injectable medications require self-injection by a patient. Self-injection of a medicament using a device having a needle carries with it a certain stigma. Oftentimes patients are weary of injecting themselves for fear or anxiety related to failing to receive a complete dose of the medication, pain associated with injecting oneself with the needle, accidentally sticking oneself with the needle, and difficulties in adequately grasping the dosing mechanism to inject oneself, among other concerns. These fears and anxieties associated with the currently available self-injection devices may result in the administration of an incomplete dose of a medicament, failure to administer any portion of the dose of a medicament, or accidentally sticking oneself with the needle of the device, which in some instances could lead to unwanted transmission of diseases if the needle is contaminated.

An additional concern exists with regard to injection devices is that users with little or no medical knowledge or experience are injecting themselves or injecting others using these devices. Performing a medical treatment or test on oneself or others carries with it certain risks and often creates a level of anxiety for the user performing the treatment or test. It has proven beneficial in the medical field to practice various medical techniques including drug delivery, specifically where it relates to injections and other invasive drug delivery means prior to delivering the medications to a patient in need, and particularly in the case of self-administration of medicaments. Training devices are helpful in reducing anxiety associated with self administering medical treatment, as well as increasing efficiency and accuracy in providing the treatment to patients. Medical devices can be intimidating to use; the fear associated with giving oneself an injection, for example, can be traumatic. This fear is increased in persons with little or no experience in self-administration of medications. Consequently, devices to assist in training individuals to inject themselves or otherwise self-administer medication are beneficial in decreasing or preventing the anxiety associated with medicament delivery. Safe use and re-use of these training devices requires a resettable device. Therefore, a device which allows repeated practice and ease of use to enhance familiarity with the injection device and the self-injection process, along with the ability to safely and efficiently reset the device is paramount to an effective device for injection training.

The present invention relates to a resettable injection training device as defined in independent claim <NUM> and relates to a method for resetting the resettable training device (<NUM>) as defined in independent claim <NUM>.

A resettable injection training device having a an outer shell including a proximal end and a distal end, the outer shell defining a chamber there within, an actuation member near a proximal end, and a plunger slidable within the chamber is provided in an embodiment herein. The device further including a safety shield having an extended locked position, an extended unlocked position and a retracted position, a locking sleeve configured to interact with the safety shield, and a reset shuttle disposed within the safety shield at a distal end of the device, wherein the reset shuttle is slidable relative to the safety shield, such that movement of the reset shuttle toward the proximal end of the device unlocks the safety shield.

In another embodiment, a resettable injection training device includes an outer shell having a proximal end and a distal end, the outer shell defining a chamber there within, an actuation member near a proximal end, and a plunger slidable within the chamber, a safety shield having an extended locked position, an extended unlocked position and a retracted position, the safety shield comprising a safety shield locking tab, said tab comprising a locking tab opening, a locking sleeve configured to surround the safety shield, said locking sleeve including one or more protrusions configured to interact with the locking tab opening when the safety shield is in an extended locked position, a reset shuttle disposed within the safety shield at a distal end of the device, wherein the reset shuttle is slidable relative to the safety shield, such that movement of the reset shuttle toward the proximal end of the device unlocks the safety shield, a cap comprising a cap end and an elongate rod comprising an interfacing surface, wherein contact between the interfacing surface of the elongate rod and the reset shuttle slides the reset shuttle relative to the safety shield to unlock the safety shield.

In still another embodiment, a method for resetting an injection training device having an outer shell defining a chamber, the device including an actuation assembly outer housing and an actuation assembly inner housing slidable relative to one another, the actuation assembly inner housing comprising one or more flexible prongs at a proximal end of the device configured to lock an actuation mechanism, a plunger slidable within the chamber, a locking safety shield movable between an extended position and a retracted position, a locking sleeve configured to interact with the safety shield, a reset shuttle disposed within a distal end of the safety shield and slidable relative there to, and a cap comprising an elongate rod for resetting the device, wherein when the safety shield is in an extended locked position, wherein insertion of the elongate rod into the chamber slides the reset shuttle relative to the safety shield, unlocking the safety shield for a subsequent use.

A more particular description briefly stated above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments and are not therefore to be considered to be limiting of its scope, the embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:.

For the purposes of promoting an understanding of the principles and operation of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to those skilled in the art to which the invention pertains.

As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise these terms do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Furthermore, to the extent that the terms "including," "includes," "having," "has," "with," or variants thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term "comprising. " Moreover, unless specifically stated, any use of the terms first, second, etc., does not denote any order, quantity or importance, but rather the terms first, second, etc., are used to distinguish one element from another. The modifier "about" used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context. It is to be noted that all ranges disclosed within this specification are inclusive and are independently combinable.

Notwithstanding that the numerical ranges and parameters setting forth the broad scope are approximations, the numerical values set forth in specific non-limiting examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges subsumed therein. As a non-limiting example, a range of "less than <NUM>" can include any and all sub-ranges between (and including) the minimum value of zero and the maximum value of <NUM>, that is, any and all sub-ranges having a minimum value of equal to or greater than zero and a maximum value of equal to or less than <NUM>, e.g., <NUM> to <NUM>. As another non-limiting example, a range of "between <NUM> and <NUM>" can also include the values <NUM>, <NUM>.

The term "adjacent" as used herein, includes but is not limited to near, associated with, or in close proximity to.

In certain embodiments herein, an actuation member is described as being in a locked and an unlocked position. In its locked position, the actuation member may still be movable and compressible; however, compression of the actuation member will not affect actuation of the device. In the unlocked position, the actuation member may be compressed to actuate the device. Therefore, when the actuation member is in the unlocked position, activation of the actuation member may actuate the device.

The inventors herein have identified a need for a device to be used in effectively training patients to use a needle-containing injection device, particularly when these injection devices are used for at home or outpatient environments. In the field of medicament injection training devices, correct injection of medicament by way of the injection device is crucial for obtaining accurate doses of medicament contained therein. Factors such as a fear of needles, fear of pain associated with an injection, inexperience with injection devices and delivering injections, and unfamiliarity with injection devices and their operation, among other factors can contribute to issues in administering the medicament correctly with the injection device. Consequently, patient training in correct operation of the injection device is crucial to reducing patient anxiety and enhancing patient compliance. In one embodiment, a resettable injection training device is provided herein.

Turning to the Figures, <FIG> is an exploded view of components of an embodiment <NUM> of a resettable injection training device <NUM> including an outer shell <NUM> having a lower outer shell portion 12a, an upper outer shell portion 12b, and an actuation member <NUM> configured to associate at a proximal end of the outer shell <NUM>. The outer shell <NUM> defines a chamber <NUM>. <FIG> shows a perspective view of an internal mechanical assembly <NUM> of the device <NUM>, and a cap <NUM>. In <FIG>, a locking sleeve interacting tab <NUM> can be found on a locking sleeve <NUM> of the internal mechanical assembly <NUM>. The locking sleeve interacting tab <NUM> is configured to interact with a locking sleeve interacting slot <NUM> on the outer shell <NUM>, such that when the locking sleeve interacting tab <NUM> is engaged within the locking sleeve interacting slot <NUM>, the locking sleeve <NUM> is stationary relative to the upper outer shell 12b. A viewing window <NUM> is shown in the lower outer shell portion 12a allowing a user to view into and/or through the device <NUM>.

Further shown in <FIG> are upper outer shell interacting ribs <NUM> of the upper outer shell 12b, which are configured to interact with an inner surface of the lower outer shell 12a, to affix upper outer shell 12b to lower outer shell 12a, in a non-limiting embodiment, when the device embodiment <NUM> is assembled. The upper outer shell and lower outer shell 12b, 12a, respectively, may alternatively be affixed to one another in a variety of ways, including but not limited to a friction fit interaction between the two components, a tab and opening interaction between the two components, wherein a tab on either the upper or lower outer shell interacts with a tab on the other of the upper or lower shell, or joined by another method such as ultrasonic welding, an adhesive, or any other such method known to those skilled in the art.

<FIG> is an exploded view of the internal mechanical assembly <NUM> including a safety shield reset assembly <NUM> having a safety shield interaction opening <NUM>, a plunger actuator mechanism assembly <NUM> with a plunger spring <NUM> and a safety shield interaction tab <NUM> configured to interact with the safety shield interaction opening <NUM> when the internal mechanical assembly <NUM> is assembled. The internal mechanical assembly <NUM> further includes a medication simulator window assembly <NUM> and the actuation member <NUM> (previously shown in <FIG>).

<FIG> is an exploded view of the plunger actuator mechanical assembly <NUM>, showing a lower plunger actuator mechanical assembly portion 22a having a plunger reset spring proximal stop portion <NUM> and the safety shield interlocking tab <NUM> shown in <FIG>. The lower plunger actuator mechanical assembly portion 22a may further include a rotation-limiting slot <NUM>. The plunger actuator mechanical assembly may further include an upper plunger actuator mechanical assembly portion 22b, including a plunger reset spring distal stop anti-rotational limiting tab <NUM> and a rotation limiting tab <NUM> for engaging with the rotation limiting slot <NUM> to prevent rotation of the lower plunger actuator mechanical assembly portion 22a relative to the upper plunger actuator mechanical assembly portion 22b when the components are assembled together. The upper plunger actuator mechanical assembly portion 22b further includes an actuation unlocking tab <NUM>, plunger locking teeth <NUM>, and a plunger spring guide <NUM> for associating with a plunger spring <NUM>. A plunger reset spring <NUM> is configured to be disposed between the plunger reset spring proximal and distal stops <NUM>, <NUM>, respectively. A plunger <NUM> having a proximal end <NUM> and a distal end <NUM> and a plunger reset groove <NUM>.

<FIG> is an exploded view of the safety shield reset assembly <NUM> having an unlock shuttle <NUM>, including sliding blocks <NUM>, guiding pillars <NUM>, safety shield <NUM>, and a locking sleeve <NUM>. The reset shuttle <NUM> includes at least one reset tooth <NUM>, each reset tooth having a tab interfacing surface <NUM>, the reset shuttle <NUM> is configured to move relative to the safety shield <NUM>, wherein when the reset shuttle moves in a proximal direction relative to the device and relative to the safety shield <NUM> to unlock and reset the device. The safety shield <NUM> further defines the chamber <NUM>, and includes a safety shield locking tab <NUM> having a locking tab opening <NUM> and a tooth interfacing surface <NUM>. The safety shield <NUM> further includes a safety shield interaction opening <NUM> for receiving the safety shield interaction tab <NUM> on the plunger actuator mechanism assembly <NUM> (see <FIG>). The locking sleeve <NUM> includes a locking sleeve interacting tab <NUM> for interacting with the locking sleeve interacting slot <NUM> of the outer shell <NUM>, such that the locking sleeve <NUM> may be secured to the outer shell <NUM> to prevent movement there between. The locking sleeve <NUM> also includes a safety lock protrusion <NUM> for interacting with the locking tab opening <NUM> on the safety shield <NUM> when the safety shield is in an extended locked position to prevent sliding of the safety shield <NUM> relative to the outer shell <NUM>. Interaction between the reset tooth (or teeth) <NUM> and the safety shield locking tab <NUM> as the reset shuttle <NUM> is moved in a proximal direction relative to the safety shield <NUM>, causes the safety shield locking tab <NUM> to bias inward, to release the safety lock protrusion <NUM> from the locking tab opening <NUM> to allow the safety shield to be reset from an extended locked position to an unlocked position. Locking sleeve further includes a sliding block rib <NUM> for interaction with the sliding block <NUM> (shown in <FIG>) during reset of the device.

<FIG> are perspective views of a sliding block <NUM> including sliding block spring <NUM>. Sliding block <NUM> includes a rib interfacing surface 32a configured to interface with a block gliding rib <NUM> of the device (block gliding rib shown in <FIG>), and a rod first portion interfacing surface 32b configured to interface with a first portion of the cap <NUM> during reset of the device <NUM>, as well as a rod interfacing surface 32c configured to interface with an elongate member shoulder of the cap <NUM> (as described below) during movement of the sliding block <NUM> in a proximal direction to reset the device <NUM>. An interaction between the angled surfaces of the rib interfacing surface 32a and the sliding block interfacing surface <NUM> of the sliding block rib <NUM> during reset of the device <NUM> causes the sliding block to move outward toward the outer shell <NUM> to allow passage of the elongate rod of the cap through the chamber <NUM> to reset the device <NUM>. The angled surfaces are complementary to one another to allow movement of the sliding block <NUM> in a proximal direction and outward toward the periphery of the device <NUM> toward the outer shell <NUM>.

<FIG> are views of a guiding pillar <NUM> having a guide spring <NUM> associated with a spring rod <NUM>. <FIG> show the guiding pillar in an extended position. <FIG> show the guide spring <NUM> of the guiding pillar <NUM>. In <FIG> the guiding pillar <NUM> is shown in a compressed position, with guide spring <NUM> compressed. The guiding pillar <NUM> prevents jamming of the device <NUM> during reset and use of the device <NUM>.

<FIG> is a cross sectional view of the embodiment <NUM> of the resettable injection training device <NUM> showing a first step in actuation of the device <NUM> in one embodiment. In <FIG>, the safety shield <NUM> is retracted (which can occur by applying a force onto the distal end of the safety shield), a step required in order to unlock the actuation member <NUM> to allow actuation of the device <NUM>. Retraction of the safety shield <NUM> causes the outer housing <NUM> to move in a proximal direction relative to the inner housing <NUM>, such that flexible prongs <NUM> at a proximal end of the inner housing <NUM> are biased inward, allowing the actuation member <NUM> to be unlocked and allowing actuation of the device <NUM> upon movement of the actuation member <NUM> in a distal direction following an application of force on the actuation member <NUM>. Chamber <NUM> is shown, and plunger <NUM> is slidable within the chamber <NUM>. Firing fingers <NUM> are shown medial to a collar <NUM> of the outer housing <NUM>. The plunger <NUM> includes a plunger groove <NUM>, wherein the firing fingers <NUM> are interfacing with the plunger groove <NUM> in <FIG>, prior to actuation of the device <NUM> via actuation member <NUM>. In <FIG>, the shield <NUM> is in a depressed position, retracted within the outer shell <NUM> of the device <NUM>, as aforementioned. By unlocking actuation member <NUM>, the actuation member <NUM> is in an actuatable, compressible position, no longer blocked by the prongs <NUM>.

<FIG> shows the embodiment <NUM> of device <NUM> shown in <FIG>, in an actuated position, demonstrating the second step in actuation of the device <NUM>, by moving actuation member <NUM> toward the proximal end of device <NUM> to actuate the device <NUM>. Actuation of the actuation member <NUM> in this manner causes the firing fingers <NUM> to move past collar <NUM>, allowing them to be released from plunger groove <NUM> such that plunger groove <NUM> may traverse the firing fingers <NUM> as the movement of the actuation member <NUM> advances the plunger <NUM> in a distal direction relative to the device <NUM>.

<FIG> is a cross sectional view of the embodiment <NUM> of the device <NUM> of <FIG> in a post actuation position with the shield <NUM> in an extended, releasably locked position following actuation. The plunger <NUM> is at the distal end of the device <NUM>, the outer housing <NUM> has moved in a proximal direction relative to the inner housing <NUM>, and the prongs <NUM> are released, locking and preventing actuation of the actuation member <NUM>. The safety lock protrusions <NUM> of the locking sleeve <NUM> are each shown as interacting with the locking tab openings <NUM> of the safety shield locking tabs <NUM> of the safety shield <NUM> to maintain the safety shield <NUM> in an extended, locked position. The plunger spring <NUM> is shown in an extended position, and the firing fingers <NUM> are not associated with the plunger groove <NUM>.

<FIG> provide a side view and a sectional view of the cap <NUM> having an elongate rod <NUM>. In some embodiments, the elongate rod <NUM> comprises a configuration that allows for a different frictional force upon insertion of the rod into the device as compared to removal of the rod from the device. The frictional force may be caused by an interaction between an outer surface of the elongate rod <NUM> and an inner surface of the device upon movement of the elongate rod <NUM> relative to the device, within the chamber. In one non-limiting embodiment, the frictional force may be caused by the interaction of the elongate rod with an inner wall of the chamber. In another non-limiting embodiment, the frictional force may be caused by an interaction between a non-uniform feature 54c on the elongate rod (described below) and an inner surface of the device defining the chamber. In some non-limiting embodiments, a different frictional force includes a greater force to remove the rod from the device than to insert the rod into the device. In other non-limiting embodiments, the different frictional force may include a greater force to insert the rod into the device than to remove the rod from the device. In a non-limiting embodiment, the elongate rod <NUM> includes a non-uniform feature 54c, shown in <FIG>. In the non-limiting embodiment of <FIG>, the cap <NUM> is shown having an elongate rod <NUM>, with a first diameter portion 54a, a second diameter portion 54b, and an optional third diameter portion 54d. A non-uniform feature 54c is shown along the elongate rod <NUM>. The cap <NUM> includes a cap end <NUM>, and an elongate member shoulder <NUM> at an intersection between the first diameter 54a and the second diameter 54b, in a non-limiting embodiment. In some non-limiting embodiments, an end portion 54d of the elongate rod <NUM> may include an arcuate shaped end, to facilitate the movement of the end portion 54d into the chamber <NUM>.

The non-uniform feature 54c is shown in greater detail in <FIG>, wherein it includes an asymmetric angled portion, in an embodiment as shown. The asymmetric angled feature may be included such that an insertion force of inserting the elongate rod portion into the device during reset is less than a removal force, the force required to remove the elongate rod portion from the device. The non-uniform feature 54c comprising a first surface <NUM> and a second surface <NUM>. A first angle phi (Φ) is formed between the longitudinal axis of the elongate rod alpha (α) and a longitudinal axis of the first surface beta (β), and a second angle theta (θ) is formed between the longitudinal axis of the elongate rod α and a longitudinal axis of the second surface gamma (γ) so as to provide the different directional force, such that the removal force required to remove the elongate rod from the device is greater than an insertion force required to insert the elongate rod into the device, in one, non-limiting example. In one non-limiting example, the first angle Φ may include an angle less than <NUM> degrees. In another non-limiting example, the second angle θ may include an angle of less than <NUM> degrees and less than the first angle Φ. The diameter of the cap end <NUM> may include between <NUM>-<NUM>. In non-limiting embodiments, the first diameter of the elongate rod may include a diameter of between <NUM>-<NUM> millimeters, and the second diameter may include a diameter of between <NUM>-<NUM>. In another non-limiting embodiment, the difference between the diameters of the first and second diameters may be <NUM>-<NUM>.

In <FIG>, the distal end of the device <NUM> is shown with the outer shell <NUM> and other outer layers removed from the device. The safety shield <NUM> is in an extended, locked position, sliding blocks <NUM> are shown as biased inward via the sliding block spring <NUM> on each sliding block <NUM>, and the sliding block rib <NUM> is shown.

In <FIG> and <FIG>, a first step in the reset of the device <NUM> is shown. The cap <NUM> having a cap end <NUM>, and an elongate rod <NUM> is provided, and is inserted into the distal end of the device <NUM> as shown, such that the first diameter 54a of the elongate rod <NUM> is within the distal end of the device, and is in contact with the first diameter interfacing surface 32b of the sliding blocks <NUM>. The elongate rod <NUM> includes dimensions allowing it to be receivable within the chamber <NUM> of the device <NUM>. The cap <NUM> is slidably engageable relative to the device <NUM> and can be used to reset the device <NUM> after actuated, to prepare the device <NUM> for a subsequent use. In a non-limiting embodiment, the diameter of the cap end <NUM> may be generally equal to the diameter of the device <NUM>. The cap <NUM> can be used to release the shield <NUM> from an extended locked position to an unlocked position, as well as reset the plunger <NUM> to a pre-actuated position, in addition to reset the actuation mechanism from a locked position to an unlocked position in preparation for a subsequent use of the device <NUM>. As shown in <FIG>, reset of the device <NUM> begins with insertion of the elongate rod <NUM> of the cap <NUM> into the distal end of the chamber <NUM>. Insertion of the first portion 54a slightly spreads the sliding blocks <NUM> apart due to the dimensions of the first portion 54a until the shoulder <NUM> interfaces with the sliding blocks. <FIG> is a view of <FIG>, wherein the device <NUM> is rotated <NUM> degrees such that the sliding blocks <NUM> can be viewed from a different angle.

Movement of the cap <NUM> further toward the proximal end of the device <NUM> as shown in <FIG>, causes the shoulder <NUM> of the elongate rod <NUM> to move the sliding blocks <NUM> toward the proximal end of the device <NUM>, wherein further movement of the sliding blocks <NUM> in this direction allows the sliding blocks <NUM> to contact the guiding block ribs <NUM>. As a result of the angles of the interfacing surfaces of the sliding blocks <NUM> and the guiding block ribs <NUM>, via the elongate rod <NUM><NUM>, and allows the reset shuttle <NUM> to move in a proximal direction, until the reset tooth <NUM> interacts with the safety shield locking tab <NUM>, to bias the tab inward as shown in <FIG>, and release the safety lock interface protrusion <NUM> from the safety shield locking tab <NUM> to allow the safety shield <NUM> to be unlocked and reset. Once the shoulder <NUM> of the elongate rod <NUM> passes the sliding blocks <NUM>, the second diameter 54b can enter further into the chamber <NUM> in a proximal direction until the end portion 54c contacts the plunger <NUM>. Further movement of the cap <NUM> in the proximal direction compresses the plunger spring <NUM> to reset the plunger <NUM>.

<FIG> shows the plunger in a post actuation position, wherein the plunger spring <NUM> is extended, and the prongs <NUM> are in a relaxed position, locking the actuation member <NUM> to prevent re-actuation of the device <NUM> until reset of the device. <FIG> shows the cap <NUM> being moved toward the proximal end of the device <NUM>, exerting a pressure on the distal end of the plunger <NUM> to reset the plunger <NUM> from a post actuation position (as in <FIG>) to a reset position. In <FIG>, the plunger <NUM> is shown in mid-reset position and the plunger spring <NUM> is partially compressed. Between <FIG>, the collar <NUM> is moved toward the proximal end of the device <NUM> from a post-actuation position to a reset position, wherein the firing fingers <NUM> are shown near the end of collar <NUM> in a reset position in <FIG> shows the plunger <NUM> in a near-reset position, wherein the firing fingers <NUM> are interfacing with the plunger groove <NUM>. <FIG> show another view of the reset of the collar <NUM>, as it is moved toward the proximal end of the device <NUM> from <FIG> during reset of the device <NUM>.

Reset of the collar <NUM> results in the outer housing <NUM> sliding relative to the inner housing <NUM> toward the proximal end of the device <NUM> such that the upper portion of the outer housing <NUM> biases the inner housing prongs <NUM> inward to reset and unlock the actuation member <NUM>. In <FIG>, the inner housing prongs <NUM> are in a position preventing the actuation member <NUM> from actuating the device <NUM> wherein any movement of the actuation member <NUM> fails to actuate the device in <FIG>. In <FIG>, the inner housing prongs <NUM> are shown biased inward allowing the unlocked actuation member <NUM> to actuate the device <NUM> when the actuation member <NUM> is moved toward a distal end of the device <NUM> upon application of a force on the actuation member <NUM>.

<FIG> is a cross sectional view of the embodiment of the device <NUM> in a fully reset position with the cap <NUM> on the device <NUM>, the firing fingers <NUM> within the plunger groove <NUM>, and the actuation member <NUM> in the locked position, wherein compression of the actuation member <NUM> fails to activate the device <NUM>, although compression of the actuation member <NUM> may move the actuation member.

<FIG> is an exploded view of another embodiment <NUM> of the device <NUM> including an outer shell <NUM> having an outer upper shell 12b and an outer lower shell 12a which may be connectable by any of the methods described herein or known to those skilled in the art. The embodiment <NUM> of the device <NUM> includes an internal mechanical assembly <NUM> including a safety shield <NUM>, and further includes a safety shield release member <NUM>, wherein activation of the safety shield release member releases the safety shield <NUM> from an extended locked position to an unlocked position. The safety shield release member <NUM> may be provided on an outer surface of the device <NUM>, and may axially and/or circumferentially aligned with the safety lock protrusion and/or safety shield locking tab <NUM> and may be configured to interact with the safety shield locking tab <NUM> (shown in the exploded view of the safety shield assembly <FIG>), in a non-limiting embodiment, on the safety shield <NUM> to compress the safety shield locking tab <NUM>, biasing it inwardly, to release the safety lock protrusion <NUM> on the locking sleeve <NUM> from the locking tab opening <NUM>.

In a non-limiting embodiment shown in the exploded view of <FIG>, the embodiment <NUM> may further include a reset shuttle <NUM>. The reset shuttle <NUM> may be used, wherein a cap or other reset tool may be inserted into the device <NUM> to effect reset of the device <NUM> by contacting the plunger (not shown), and moving the plunger to a pre-use position, toward the proximal end of the device <NUM> for a subsequent use.

<FIG> shows a perspective view of another embodiment <NUM> of a resettable injection training device with a housing <NUM>. <FIG> shows a partially disassembled view of the embodiment <NUM>. The embodiment <NUM> includes two housing components 105a,b that engaged together with an internal mechanical assembly <NUM> provided therein. The housing components 105a,b are secured together by interacting ribs <NUM> on housing component 105b via a snap or frictional fit. The mechanical assembly <NUM> comprises multiple subassemblies that will be further described below. The mechanical assembly includes an anti-rotational groove <NUM> that interacts with a protrusion (not shown) provided in the housing component 105b as well as a locking interacting tab <NUM> which interacts with opening <NUM> on housing component 105b to interlock housing component 105b with internal mechanical assembly <NUM> when the device is assembled. Also shown in <FIG> is a cap <NUM> that includes reset rod <NUM>'.

<FIG> shows a partially disassembled view of the mechanical assembly <NUM> shown in <FIG>. The mechanical assembly <NUM> includes a locking safety shield assembly <NUM>, a medication simulator window assembly <NUM> (including the plunger component <NUM>) and an actuation assembly <NUM>. A rotatable locking sleeve <NUM> is associated with the proximal end of the safety shield assembly <NUM>. The actuation assembly <NUM> includes a plunger actuation spring 115a that is inserted into the proximal end <NUM>' of the plunger <NUM>. The actuation assembly <NUM> includes plunger locking arms <NUM> (<NUM> total, <NUM> shown) that have a plunger catch <NUM>' that extend inwardly and interact with the plunger groove <NUM> (<FIG>). Disposed on a portion of the outer surface of the assembly <NUM> is the rotatable locking sleeve reset spring 115b. As will be explained in relation to <FIG>, during actuation, the plunger locking portion <NUM> deflects to release the plunger <NUM>.

The actuation assembly <NUM> associates with a button <NUM> at its proximal end. The actuation assembly <NUM> also includes a proximal ramp portion <NUM> that interacts with an actuation releasing portion <NUM> of the locking sleeve <NUM>. The actuation assembly further includes a locking tab <NUM> that interacts with catch member <NUM> of the outer housing (see <FIG>). The distal end of the safety shield assembly <NUM> includes the safety shield distal portion <NUM>.

<FIG> shows a perspective view of a further disassembled view of the safety shield assembly <NUM> as well as the actuation collar reset spring <NUM>, actuation collar <NUM>, and plunger reset ring <NUM> contained within the safety shield assembly <NUM>, and the rotatable locking sleeve <NUM> that is partially contained within the safety shield assembly <NUM>. The safety shield assembly includes two components <NUM>' and <NUM>" that lock together via locking opening 110c and locking tab 110d. Component <NUM>" includes a locking opening 110a that interacts with locking tab <NUM>' provided on the plunger reset ring <NUM>. The rotatable locking sleeve <NUM> includes an actuation releasing portion <NUM> whose function will be described in relation to <FIG>and <FIG>herein. Rotatable locking sleeve <NUM> also includes a locking protrusion window <NUM>' that interacts with sleeve locking protrusion <NUM>' of the actuation assembly <NUM>.

<FIG> shows an end perspective view of the locking sleeve <NUM> to show certain features provided therein. As seen is a plunger interacting ramp <NUM> and plunger interacting groove <NUM> that interact with the plunger tab <NUM> (<FIG>) as described in relation to <FIG>and <FIG>.

<FIG> is a perspective view of the plunger <NUM>. The plunger <NUM> includes a plunger end opening <NUM> on the proximal end <NUM>', a plunger groove <NUM>, plunger anti-rotational rail <NUM>, and a plunger tab <NUM>.

<FIG> shows a series of cut-away views that illustrate the action of certain internal components of the embodiment <NUM>. From left to right, the series represents different states of the embodiment <NUM>: a reset and ready to fire state (state <NUM>, <FIG>), safety shield depressed (state <NUM>, <FIG>), button actuated (state <NUM>, <FIG>), plunger and locking sleeve movement (state <NUM>, <FIG>), and injection complete state with safety shield in extended locked position (state <NUM>, <FIG>). For state <NUM>, the safety shield assembly <NUM> is in an extended reset position. The actuation collar <NUM> covers and holds the plunger locking portion (not shown for state <NUM>). Actuation requires that the safety shield assembly <NUM> and the actuation button <NUM> be depressed at the same time. If one or the other, but not both, is depressed the plunger will not fire. In state <NUM>, the safety shield <NUM> is depressed. This causes the safety shield assembly <NUM>, the locking sleeve <NUM> and the actuation collar <NUM> to slide up. As can be seen, the outside of the plunger locking arms <NUM> extend slightly under the actuation collar <NUM>. Also, the actuation release portion <NUM> abuts against the ramp portion <NUM>, which stages the embodiment <NUM> for firing if the button <NUM> is actuated. State <NUM> shows the button <NUM> in a depressed state which pushes the plunger locking arm <NUM> fully past the actuation collar <NUM>, which causes the firing of the plunger <NUM> by allowing the plunger locking arm <NUM> to deflect out thereby releasing the plunger <NUM> (the plunger catch <NUM>' (<FIG>) releases from plunger groove <NUM> (<FIG>)). In state <NUM>, the plunger actuation spring (115a, <FIG>) drives the plunger <NUM> toward the distal end of the embodiment <NUM>. As the plunger <NUM> travels distally, the locking sleeve <NUM> rotates (see arrow). In state <NUM>, once the plunger <NUM> has fully traveled to its distal position, the safety shield distal portion <NUM> is released and the safety shield assembly and locking sleeve are urged distally by locking sleeve spring 115b to assume the extended locked position of the safety shield assembly <NUM>. The locking sleeve <NUM> locks by interfacing between a sleeve locking member <NUM> and a sleeve locking protrusion <NUM>' associated with the actuation assembly <NUM>. The change of the relative positioning of the locking protrusion <NUM>' and sleeve locking member <NUM> is shown from state to state. As the injection simulation is occurring during state <NUM>, the plunger <NUM> can be seen moving through viewing window <NUM>' (<FIG>).

<FIG> shows a side view of the locking sleeve <NUM> that shows the interaction of the plunger tab <NUM> with the plunger interacting groove <NUM>. <FIG> shows the plunger tab <NUM> in the plunger interacting groove. As the plunger <NUM> moves distally, the plunger tab <NUM> interacts with the plunger interacting ramp <NUM> as shown in <FIG>. Locking sleeve spring 115b urges the locking sleeve to rotate as the plunger tab <NUM> traverses the plunger interacting ramp <NUM>. This rotation of the locking sleeve <NUM> allows the interaction between the sleeve locking member <NUM> and sleeve locking protrusion <NUM>' as discussed above in relation to <FIG>.

<FIG>, <FIG> and <FIG> show the first stage of the process of resetting embodiment <NUM> after injection simulation is completed and the safety shield assembly <NUM> is in its extended locked position. The reset rod <NUM> is inserted into the distal end of the safety shield <NUM> and abuts against the distal end of the plunger <NUM>. The plunger <NUM> is pushed up toward the proximal end of the embodiment <NUM>, which unlocks the safety shield assembly <NUM> as shown in <FIG>. Unlocking of the safety shield assembly <NUM> is caused by the interaction of the plunger tab <NUM> and the plunger interacting ramp <NUM> (shown in <FIG>) which rotates the locking sleeve <NUM> such that the sleeve locking member <NUM> and sleeve locking protrusion <NUM>' disengage. Once unlocked, the safety shield assembly <NUM> and locking sleeve <NUM> continue to be moved toward the proximal end of the embodiment <NUM>.

Next, reset of the actuation assembly and plunger will be discussed in relation to <FIG> and <FIG>. <FIG> shows a side perspective view of the actuation collar <NUM>. The actuation collar <NUM> includes an actuation reset ramp <NUM> that interacts with the distal end of the plunger locking portion <NUM>. The plunger locking portion <NUM> (plunger unlocking portion <NUM> shown in <FIG>) includes a collar interacting ridge <NUM>'' that interacts with the actuation reset ramp <NUM>. As shown in <FIG>, as the plunger <NUM> moves proximally during reset, the actuation collar rotates slightly and the reset ramp <NUM> is urged into the gap <NUM>" between respective plunger locking arms <NUM>. The actuation collar reset spring <NUM> urges the actuation collar <NUM> up in a proximal direction until the actuation reset ramp <NUM> passes the collar interacting ridge <NUM>" and slides back over such that the actuation reset ramp <NUM> catches the collar interacting ridge <NUM>'' to hold the actuation collar <NUM> over the plunger locking arms <NUM>. This holds the plunger in place until injection is initiated as described in <FIG>.

<FIG> shows a longitudinal cross-section view of embodiment <NUM> with the cap <NUM> and reset rod <NUM>' fully inserted for resetting. The close up portion shows the plunger catch <NUM>' interacting with the plunger ridge <NUM> thereby holding the plunger <NUM> in the reset position. Also shown is the plunger actuation spring 115a. Also shown are the actuation collar <NUM> and the actuation reset ramp <NUM>. Given the complexity of the foregoing arrangement, the elements discussed with respect to <FIG> are shown in cross-section view without cross-hatching.

<FIG> shows a cross-sectional view of embodiment <NUM> in the fully reset position with the cap <NUM> and reset rod <NUM>' removed. Close-up <FIG> shows the plunger catch <NUM>' interacting with the plunger ridge <NUM> from a different perspective to that shown in <FIG>. <FIG> shows a close-up of the proximal end of the embodiment showing the ramp portion <NUM>, catch member <NUM> and locking tab <NUM>. As discussed in reference to <FIG>, if the button <NUM> is pushed with the ramp portion being deflected inwardly, the locking tab <NUM> will hit the catch member <NUM>, thereby preventing accidental firing of the embodiment <NUM>.

Claim 1:
A resettable injection training device (<NUM>), comprising:
an outer shell (<NUM>) comprising a proximal end and a distal end, the outer shell (<NUM>) defining a chamber (<NUM>) there within;
a plunger (<NUM>) slidable within the chamber (<NUM>), the plunger (<NUM>) comprising a plunger tab (<NUM>);
a safety shield assembly (<NUM>) disposed and slidable within the chamber (<NUM>) and comprising a proximal end and a distal end, the safety shield assembly (<NUM>) comprising an extended locked position, an extended reset position, and a retracted position;
a locking sleeve (<NUM>) disposed at the proximal end of the safety shield assembly (<NUM>), the locking sleeve (<NUM>) comprising a plunger interacting ramp (<NUM>) and plunger interacting groove (<NUM>) for interfacing with the plunger tab (<NUM>);
a button (<NUM>) at the proximal end of the device;
an actuation assembly (<NUM>) comprising a proximal end and a distal end, the actuation assembly (<NUM>) comprising an actuator portion at the proximal end, said proximal end for associating with the button (<NUM>), and a plunger locking portion (<NUM>) at the distal end;
an actuation collar (<NUM>) disposed at the distal end of the actuation assembly (<NUM>), wherein the actuation collar (<NUM>) interacts with the plunger locking portion (<NUM>) to hold the plunger (<NUM>) in a pre-fired position, wherein
the plunger (<NUM>) further comprises a plunger groove (<NUM>);
the plunger locking portion (<NUM>) comprises a plunger catch (<NUM>') that engages with the plunger groove (<NUM>); and
wherein when the safety shield assembly (<NUM>) is in the retracted position and the actuator portion is depressed, the plunger catch (<NUM>') disengages from the plunger groove (<NUM>) thereby firing the plunger (<NUM>) to start injection simulation.