Rotatably unlocked resettable shield actuated autoinjector training device

A resettable injection training device embodiment including an outer housing having a proximal end and a distal end, the housing defining a chamber there within, a safety shield having a proximal end and a distal end, the safety shield having a retracted, locked position, a first extended unlocked position, a second extended unlocked position, and a second extended locked position is described herein. The device embodiment including a plunger having a proximal a distal end, the plunger having a retracted and an extended position. The device may include a rotating plunger locking collar, an unlocking member coupled to the plunger, wherein rotation of the unlocking member from a first position to a second position unlocks the device and releases the safety shield from the retracted, locked position. The device may further include a resetting cap for resetting the device for a subsequent use.

BACKGROUND

Injection devices have recently become increasingly popular for single dose or multi-dose, at home self-administration. 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 wary 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 that 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.

SUMMARY

In one embodiment, a resettable injection training device is provided including an outer housing having a proximal end and a distal end, the housing defining a chamber there within, a safety shield having a proximal end and a distal end, the safety shield having a retracted, locked position, a first extended unlocked position, a second extended unlocked position, and a second extended locked position, and a plunger having a proximal end and a distal end, the plunger having a retracted position and an extended position. The device may further include a rotating plunger locking collar, an unlocking member coupled to the plunger, wherein rotation of the unlocking member from a first position to a second position unlocks the device and releases the safety shield from the retracted, locked position, and a resetting cap, wherein removal of the resetting cap from a distal end of the housing allows the safety shield to move from the first extended unlocked position to the second extended unlocked position.

In another embodiment, a method of resetting a resettable injection training device is provided, having a safety shield in a second extended, locked position and a plunger is in an extended position. The method includes inserting a resetting cap into a distal end of a resettable injection training device having a proximal end and a distal end, the device comprising an outer housing defining a chamber there within, a safety shield having a retracted locked position, a first extended unlocked position, a second extended unlocked position, and a second extended locked position, a plunger having a retracted position and an extended position, and a rotating plunger locking collar, wherein the safety shield is in the second extended, locked position, and moving the cap in a proximal direction relative to the device to contact the plunger and reset the plunger from an extended position to the retracted position, and reset the safety shield from the second extended, locked position to the retracted, locked position.

DETAILED DESCRIPTION

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.

In one non-limiting embodiment, a resettable injection training device100is provided s shown in the perspective view ofFIG. 1A. In one non-limiting embodiment, the device100may include a manual needle insertion simulation device, wherein the device100simulates the sensation that occurs to a user during the use of a manual needle insertion autoinjector device. In a manual needle insertion autoinjector device, as the device including an extended safety shield is pressed against the contact surface of a target area of a user, the needle is inserted into the target area.

The device100may include, in one embodiment, an outer housing110having a proximal end110aand a distal end110b, the housing110defining a chamber112there within. The device may further include a safety shield114having a proximal end114aand a distal end114b, the safety shield114having a retracted, locked position as shown in a perspective view of the device inFIGS. 1A and 1nFIG. 7, a first extended unlocked position as shown inFIG. 8, a second extended unlocked position as shown inFIG. 10, and a second extended locked position as shown inFIG. 14. The device100further includes a plunger116, shown in the exploded view ofFIG. 1BandFIGS. 4A-4C. The plunger116includes a proximal end116aand a distal end116b, the plunger116having a retracted position and an extended position. An unlocking member118may be coupled to the proximal end of the plunger116aas shown inFIGS. 4A-C, wherein rotation of the unlocking member118from a locked first position (seeFIG. 7) to an unlocked second position (seeFIG. 8) unlocks the device100and releases the safety shield114from its retracted, locked position as shown inFIG. 8.

FIG. 1Bfurther provides an exploded view of the components of the device100, including the outer housing110having the proximal end110aand distal end110b. A safety shield114can be disposed within the outer housing110, in one embodiment. The safety shield includes the proximal end114aand distal end114b. A plunger116having an unlocking member118coupled to its proximal end, and a plunger locking tab119shown on the plunger. a rotating plunger locking collar122is also shown, and a reset cap129is provided. In the retracted, locked position, a portion of the safety shield114interfaces with the plunger locking tab119to maintain the safety shield in the retracted, locked position until the device100is unlocked by rotation of the unlocking member118as will be described in more detail herein.

FIGS. 2A-2Binclude perspective and side views, respectively, of an embodiment of a safety shield reset lock170, having a protrusion172, and a projection175. The safety shield reset lock170may also include a safety shield reset unlocking ramp174on a portion of the projection175, in one embodiment. Plunger rail guides176are shown inFIG. 2A, and are provided to guide the plunger116, when the plunger116moves along the longitudinal axis of the device100during use. The safety shield reset lock170may be used during reset of the device100, wherein it may interact with a portion of the distal end of the plunger116bas shown inFIG. 4D, and as will be explained in greater detail.

FIGS. 3A-3Dinclude various views of a safety shield114according to one embodiment of the device100.FIG. 3Aprovides a perspective view of the safety shield114including a proximal end114a, and a distal end114b. The safety shield114may include a viewing window109. At its proximal end, the safety shield114may include a safety shield ridge113and a safety shield unlocking slot115. The safety shield ridge113interfaces with the plunger locking tab119to maintain the safety shield114in a reset, locked position, when the unlocking member is locked. Once the unlocking member118is unlocked (by rotation of the unlocking member118, therefore rotating the locking tab119), the locking tab aligns with the unlocking slot115at the proximal end of the safety shield114, allowing the safety shield114to be released from its retracted, locked position as shown inFIG. 8.

FIG. 3Bprovides an exploded view of an embodiment of the safety shield114, having an outer portion101and an internal housing104. In the outer portion101of the safety shield114, a device status window108may be provided, and an optional threaded portion99is provided on a distal end thereof.FIG. 3Cis a cross-sectional view of the safety shield114embodiment, taken at A-A ofFIG. 3D, providing a view of the device status window108.FIG. 3Dprovides a side view of the safety shield114.

FIGS. 4A-4Cinclude various views of an embodiment of a plunger116. The plunger116includes a proximal end116a, a distal end116b, a plunger locking tab119featured near the proximal end116aand an unlocking member118disposed at the proximal end116aof the plunger. In one non-limiting embodiment, the unlocking member118is coupled to the plunger116, such that rotation of the unlocking member118, cooperatively rotates the plunger116.FIG. 4Ais a perspective view of the plunger, andFIG. 4Bis a side view of the plunger116embodiment, wherein the cross-sectional view of the plunger shown inFIG. 4Cis taken at C-C ofFIG. 4B.

FIG. 4Dprovides an exploded view of the plunger embodiment116, wherein a plunger rod103having a plunger protrusion117is shown. The plunger rod103is configured to be placed within the plunger116main housing as shown inFIG. 4D. On a distal portion of the plunger, a plunger ramp179is provided. This plunger ramp179may interface with the projections175on the safety shield reset lock170(ofFIGS. 2A-2B) during reset of the device100. One or more biasing members are associated with the plunger to allow rotation, extension and retraction of the plunger116. A vial component102is also provided, wherein the vial component102may appear in the viewing window109of the safety shield114when the device100is assembled. In another, non-limiting embodiment, the viewing window109may be used to provide a view into the internal components of the device100. The vial component102may include information about the device100, an image or graphic may indicate the current state of the device100during use of the device100, or other images or information. In one non-limiting example, two or more images may be provided on the vial component102, wherein one image shows a drug in a pre-mixed state, and another image shows the drug in a mixed state, so a user can distinguish the visual difference between the appearance of the drug when it is mixed versus unmixed. This can be used to train a user to correctly mix a drug by manipulating the device100, for example, prior to use. The two or more images may be viewed at the same time on the vial component102, by rotation of the device100. Two or more viewing windows109may also be provided on the device100to view the images.

FIGS. 5A-Dprovide various views of an embodiment of a rotating plunger locking collar122.FIG. 5Ais a perspective view of the rotating plunger locking collar122, having a locking collar base126, a biasing member124, and a locking collar ring125. In the embodiment shown herein, the base126and the ring125are shown as separate components; however, these components may be provided as one single component in another non-limiting embodiment. On an inner surface of the locking collar base126, a reset ramp121may be found. The reset ramp121is involved in reset of the device100as will be described in greater detail in the Figures that follow. The rotating plunger locking collar122also includes a safety shield locking tab123as shown.

FIG. 5Bshows an exploded view of an embodiment of the rotating plunger locking collar122, wherein a biasing member124is provided as a torque spring, in one non-limiting embodiment. Near a lower portion of the locking collar base126, a locking notch176is provided. The locking tab123is also shown on the base126portion. The locking collar ring125includes a number of projections extending into the center of the ring125as shown inFIG. 5C. Each projection includes a rotating plunger locking collar protrusion128, and a plunger reset ramp131as shown inFIG. 5D. In the assembled view ofFIG. 5A, an unlocking groove130can be seen.

FIGS. 6A-6Dprovide various views of a resetting cap embodiment129, which may be provided on the distal end of the device100and function as a cap, but may also be used to reset the device100following use thereof, from a post-use position, to a pre-use position.FIG. 6Aprovides a perspective view of the resetting cap129, showing the reset rod portion133and a reset body portion138having a flange98for interfacing with a distal portion of the device100(in some instances, a distal portion of the safety shield114b).FIG. 6Bis a side view of the reset cap129, also showing the reset rod portion133, andFIG. 6Cis a cross sectional view of the resetting cap129, wherein the cross section is taken at E-E ofFIG. 6B, showing the reset rod portion133and a thread portion139for interfacing with a threaded portion of the safety shield99shown inFIG. 3B.FIG. 6Dis a sectional view of the resetting cap129showing thread portion139.

General operation of the device embodiment100is shown in the subsequent Figures. The operation shown may be modified, and the following is only presented as a non-limiting example of the function of the device100.FIG. 7includes a partial cutaway view of the device100prior to use. Rotation of the unlocking member118, effectively rotates the plunger116as described above, such that the plunger locking tab119is rotated to align with the unlocking slot115of the safety shield114, allowing the safety shield114to be unlocked from its reset position, and released as shown inFIG. 8. The safety shield114moves distally until its distal end114babuts the resetting cap129as can be seen inFIG. 8, limiting its distal movement.FIG. 7also shows the safety shield locking member134, and safety shield locking tab123, and the spatial orientation of the two prior to use of the device100.

Once the unlocking member118is unlocked and the safety shield114has extended to the first, extended unlocked position, which is maintained by the resetting cap129on the distal end of the device, the resetting cap129may be removed from the device100as shown in the partial cutaway view ofFIGS. 9-10, to allow the safety shield114to fully extend to its second extended, unlocked position for use. Removal of the resetting cap129may occur in a number of ways; however, in the embodiment shown herein, removal occurs by twisting the resetting cap129off of the device100. The distal portion of the internal assembly of the safety shield114includes a threaded member, and the resetting cap129includes a complementary threaded portion on an inner surface thereof, such that selectively twisting the cap onto the device mates the threads with one another and maintains the cap on the device. Twisting in the opposite direction, un-mates the threads and removes the resetting cap129from the device. However, as aforementioned, in other embodiments, the cap129may not be threaded, but may simply be friction fitted to the device100, or removably fit to the device100in another manner, such that it may be removed by pulling the cap129from the end of the device100.

Once the resetting cap129is removed from the distal end of the device100, the safety shield114is allowed to extend to its second extended unlocked position as shown inFIG. 10, due to a safety shield biasing member180force extending the safety shield114as shown inFIGS. 8-10. The biasing member180may be embodied as a compression spring, in one nonlimiting embodiment.

In the partial cutaway view ofFIG. 10, the cap129(not shown inFIG. 10) has been removed, and the safety shield114has fully extended to a second extended, unlocked position as described. The movement of the locking tab123can be shown inFIGS. 9-10during operation of the device100. When the shield114is in the second extended, unlocked position, the device100is ready for actuation. Pressing the safety shield114down onto a surface (i.e., a target surface of a user), or initiating a force onto the distal end of the safety shield to move the safety shield in a proximal direction relative to the device100initiates actuation of the simulated injection of the device100as shown inFIG. 11. During this actuation, a safety shield unlocking ramp132interfaces with the safety shield locking tab123, so as to rotate the rotating plunger locking collar122, moving the plunger locking collar protrusion128out of the way of the plunger tab117, allowing the plunger tab117to align with the unlocking groove130on the rotating plunger locking collar122providing release of the plunger116in a distal direction to complete actuation of the device100as shown inFIG. 12. The plunger biasing member releases energy to extend the plunger116distally. Completing one actuation of the device100, rendering the device100in the post-use position shown inFIG. 13.

Once the device has been actuated, the force on the safety shield distal end is removed (i.e., by lifting the device100from the target surface of the user), the safety shield locking tab123moves past the safety shield locking member134, and the safety shield114extends to a second extended locked position as shown inFIG. 14. The second extended locked position of the safety shield is maintained, at least in part, by an interaction between the locking tab123and the safety shield locking member134in this position as shown inFIG. 14. Once the device100has been used, it can be reset for a subsequent use.

Reset of the device100may occur, in one embodiment, by rotation of the unlocking member118to lock the unlocking member (in one non-limiting example, rotation occurs in a direction opposite the direction required to unlock the unlocking member118) prior to the subsequent steps of resetting the device100. However, in other embodiments, this first step of locking the unlocking member118may not be required.FIG. 15shows a partial cutaway view of the device following use, prior to rotation of the unlocking member118, wherein the Following locking of the unlocking member118, wherein the protrusion172interfaces with a locking notch176of the rotating plunger locking collar128. Therefore, preventing resetting of the device100with the resetting cap129until the unlocking member118is locked, (positioned back to its starting position). Locking of the unlocking member118as shown inFIG. 16, creates a gap174between the protrusion and the locking notch176, allowing the device to be reset with the resetting cap179. This gap174is created by way of an interaction between the safety shield reset unlocking ramp174on a portion of the projection175of the safety shield reset lock170and the plunger ramp179on the distal end of the plunger116.

As shown in the partial cutaway views ofFIGS. 17-18, placement of the resetting cap129, having a reset cap body portion138and a reset rod portion133, on the distal portion of the device100(distal end of the safety shield114b) allows the reset to continue (or in some instances, initiates the reset) of the device100. Continued movement of the resetting cap129in a proximal direction continues the reset process. Movement of the resetting cap129in a proximal direction relative to the device100so that the reset rod portion133interfaces with the distal portion of the plunger116b, continues the reset. This action moves the plunger116in a proximal direction, wherein the plunger protrusion117interfaces with the reset ramp140, to rotate the rotating plunger locking collar122to a reset position, and allowing the plunger116to further move toward the proximal end of the device100to its reset position.

Completion of the reset occurs by an interface between the flange98on the reset cap body138portion and a distal portion of the safety shield114b, as shown inFIG. 18. Completion of the reset may occur by twisting the resetting cap129to thread the cap onto the distal end of the inner housing of the safety shield114, in instances where a threaded cap and threaded device portion are mated together, or by sliding the resetting cap129onto the distal end of the device100or safety shield114, specifically, (in embodiments wherein the reset cap129is not threaded).FIG. 18shows the internal housing view of the device in a fully reset position, wherein the shield is in a retracted, locked position.FIGS. 19-20provide a view of the outer portion of the device100, showing the outer assembly view ofFIGS. 17-18, respectively.FIG. 20, wherein the device100is in a reset position, the safety shield locking tab123can be found in its original starting position.

In embodiments herein, a device100including a device status window108in the safety shield114may be provided to demonstrate a status of the device100during use to a user by viewing the position of the safety shield locking tab123, which moves within the status window108throughout the use and reset of the device100as can be seen in the corresponding Figures herein.

As used herein, the terms “subject”, “user” and “patient” are used interchangeably. As used herein, the term “subject” refers to an animal, preferably a mammal such as a non-primate (e.g., cows, pigs, horses, cats, dogs, rats etc.) and a primate (e.g., monkey and human), and most preferably a human.

It is to be noted that the terms “first,” “second,” and the like as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms “a” and “an” 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.” The modifier “about” used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context (e.g., includes the degree of error associated with measurement of the particular quantity). It is to be noted that all ranges disclosed within this specification are inclusive and are independently combinable.

It should be borne in mind that all patents, patent applications, patent publications, technical publications, scientific publications, and other references referenced herein are hereby incorporated by reference in this application in order to more fully describe the state of the art to which the present invention pertains.

Reference to particular buffers, media, reagents, cells, culture conditions and the like, or to some subclass of same, is not intended to be limiting, but should be read to include all such related materials that one of ordinary skill in the art would recognize as being of interest or value in the particular context in which that discussion is presented. For example, it is often possible to substitute one buffer system or culture medium for another, such that a different but known way is used to achieve the same goals as those to which the use of a suggested method, material or composition is directed.

It is important to an understanding of the present invention to note that all technical and scientific terms used herein, unless defined herein, are intended to have the same meaning as commonly understood by one of ordinary skill in the art. The techniques employed herein are also those that are known to one of ordinary skill in the art, unless stated otherwise. For purposes of more clearly facilitating an understanding the invention as disclosed and claimed herein, the following definitions are provided.

While a number of embodiments of the present invention have been shown and described herein in the present context, such embodiments are provided by way of example only, and not of limitation. Numerous variations, changes and substitutions will occur to those of skill in the art without materially departing from the invention herein. For example, the present invention need not be limited to best mode disclosed herein, since other applications can equally benefit from the teachings of the present invention. Also, in the claims, means-plus-function and step-plus-function clauses are intended to cover the structures and acts, respectively, described herein as performing the recited function and not only structural equivalents or act equivalents, but also equivalent structures or equivalent acts, respectively. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims, in accordance with relevant law as to their interpretation.