Medication delivery device with audible feedback during injection

Abstract

An automatic injection device is provided, where the device includes: a plunger axially moveable during an injection event; a shuttle through which the plunger moves during the injection event, the shuttle comprising: a proximal end, a distal end, and a portion extending between the proximal end and the distal end; and a plurality of teeth fixed along the portion extending between the proximal end and the distal end; and a clicker protrusion fixed along the plunger, wherein the clicker protrusion is configured to engage the plurality of teeth as the plunger moves through the shuttle during the injection event, thereby producing auditory feedback.

Description

MEDICATION DELIVERY DEVICE WITH AUDIBLE FEEDBACK DURING INJECTIONBACKGROUND

[0001] Aspects herein pertain to pharmaceutical injection devices, and, in particular, to automatic injection devices.

[0002] Conventional injection devices are often used to inject a medication into a patient via a needle. It is sometimes advantageous for the medication to be administered without the presence of a medical professional, such as when the medication is to be administered frequently (e.g., daily at different times during each day). However, it may be challenging to ensure that the patient is properly operating the device, and that the medication is administered safely, efficiently, and in the proper amount. Furthermore, some patients may suffer from cognitive impairment, dementia, Alzheimer’s disease, and / or one or more conditions that otherwise affect the patient’s ability to properly use an injection device to administer medication.SUMMARY

[0003] According to an exemplary embodiment of the present disclosure, an automatic injection device is provided. In some embodiments, the automatic injection device includes: a plunger axially moveable during an injection event; a shuttle through which the plunger moves during the injection event, the shuttle comprising: a proximal end, a distal end, and a portion extending between the proximal end and the distal end; and a plurality of teeth fixed along the portion extending between the proximal end and the distal end; and a clicker protrusion fixed along the plunger, wherein the clicker protrusion is configured to engage the plurality of teeth as the plunger moves through the shuttle during the injection event, thereby producing auditory feedback.

[0004] In another embodiment, a method of providing auditory feedback to a user of a medication delivery device is provided. The medication delivery device includes a plunger, and a shuttle through which the plunger is moved during an injection event. The shuttle includes a proximal end, a distal end, and a portion extending between the proximal end and the distal end. A plurality of teeth is fixed along the portion extending between the proximal end and the distal end of the shuttle. A clicker protrusion is fixed along the plunger. The method includes one or more of the following steps: Actuating the plunger to axially moverelative to the shuttle during the injection event. Enabling the engagement of the clicker protrusion of the plunger with the plurality of teeth of the shuttle as the plunger is axially moved relative to the shuttle, thereby producing auditory feedback during the injection event.BRIEF DESCRIPTION OF DRAWINGS

[0005] Various aspects, techniques, and embodiments of the present technology disclosed herein are described below in reference to the accompanying drawings. It should be appreciated that the figures are not necessarily drawn to scale. Items appearing in multiple figures may be indicated by the same reference numeral. For purposes of clarity, not every component may be labeled in every figure. Features of the present technology will become more apparent and techniques for how to attain the features of the present technology will be better understood by reference to the following detailed description considered in conjunction with the accompanying drawings, wherein:

[0006] FIG. 1 is a side view of an automatic injection device with a trigger assembly of according to one embodiment, which device is shown in a locked arrangement prior to use.

[0007] FIG. 2 is a longitudinal cross-sectional view of the automatic injection device of FIG. 1 with the overcap removed.

[0008] FIG. 3 is a perspective view of a button shown separate from the other components of the device of FIG. 1.

[0009] FIGs. 4A and 4B are respectively a perspective view and a partial side view of a plunger element shown separate from the other device components.

[0010] FIGs. 5A, 5B, 5C, and 5D are perspective views of a plunger element with a clicker protrusion fixed thereon, according to some embodiments.

[0011] FIG. 6A is an assembly including a syringe, syringe carrier, and plunger element, with the syringe shown in phantom.

[0012] FIG. 6B is the assembly of FIG. 6A with one part of the syringe carrier hidden from view and the syringe shown in solid.

[0013] FIG. 6C is an enlarged view of a portion of FIG. 6B.

[0014] FIG. 7 is a perspective view of a proximal shuttle part shown separate from the other device components.

[0015] FIGs. 8A, 8B, 8C, 8D and 8E are respectively perspective, first side, longitudinal cross-sectional, top and bottom views of a distal shuttle part shown separate from the other device components.

[0016] FIGs. 9A, 9B, 9C, 9D and 9E are respectively first perspective, first side, second perspective, second side and longitudinal cross-sectional views of a follower shown separate from the other device components.

[0017] FIG. 10A is an assembly including a distal shuttle and a follower, the follower being shown in the coupled configuration.

[0018] FIG. 10B is a slightly rotated view of the assembly of FIG. 10A to show the interaction between a latch of the follower with a protrusion of the distal shuttle.

[0019] FIG. 11 is an exploded view of the assembly of FIG. 10 A.

[0020] FIG. 12A is a perspective view of a distal shuttle.

[0021] FIG. 12B is another perspective view of the distal shuttle of FIG. 12 A.

[0022] FIGs. 13 A and 13B are perspective views of a distal shuttle that includes a plurality of teeth, according to some embodiments.

[0023] FIG. 14 is a longitudinal cross-sectional view of the automatic injection device in its ready to operate arrangement.

[0024] FIG. 15 is a longitudinal cross-sectional view of the automatic injection device after the automatic injection device has been triggered for injection.

[0025] FIG. 16 is a perspective internal view of an automatic injection device, depicting another embodiment of the clicker protrusion in engagement with teeth along the plunger.

[0026] FIG. 17 is a perspective internal view of an automatic injection device, depicting another embodiment of the clicker protrusion integrated into the syringe carrier and in engagement with teeth along the plunger.DETAILED DESCRIPTION

[0027] Provided herein are examples of injection devices (e.g., medication delivery devices), as well as examples of components included in the injection devices and techniques for operating the injection devices. As will be appreciated, although some examples of the injection devices are described herein in connection with administering medication to a patient, such devices are not limited to use in medical applications and may additionally or alternatively be used in non-medical applications (e.g., where a precise amount of fluid is to be delivered).

[0028] The inventors have recognized and appreciated that various factors can be important for injection devices. For example, ease of use and user safety are factors that canbe important for operators of an injection device. The inventors have recognized that some operators may suffer from one or more conditions (e.g., cognitive impairment, dementia, Alzheimer’s disease, etc.) that impact their ability to easily and safely operate an injection device. For example, during an injection event, such operators may remove the dose delivery device from skin prior to a delivery of a full dose amount, also known as early lift-off. Other operators may release the dose delivery button too soon (e.g., due to a lapse in memory) for such devices that require such actuation, thereby failing to administer the full dose amount.

[0029] Accordingly, the inventors have developed a mechanism for providing feedback to operators of the injection devices described herein to assist operators in using the device to safely administer proper dose amounts. In some embodiments, the feedback mechanism is an auditory feedback mechanism. For example, embodiments of the injection devices provided herein may include a clicker protrusion and a plurality of teeth. When an operator depresses a button to deliver a dose of medication using the injection device, the clicker protrusion may be configured to engage the plurality of teeth, thereby producing auditory feedback (e.g., clicks) during delivery. The auditory feedback reminds the operator to continue to hold the device against the skin until the full dose amount has been delivered. The lack of auditory feedback may remind the operator to adjust the configuration of the injection device. The clicking sound that is produced during dose injecting may be useful for the operator to understand how an injection is progressing.

[0030] Referring now to FIGs. 1 and 2, there are shown different views of a first embodiment of an automatic injection device, generally designated 20, with a trigger assembly. When the trigger assembly is operated, the needled syringe of the device 20 is automatically driven downward such that the injection needle projects beyond the distal end of the device housing to penetrate the user. The device may then proceed to inject automatically, that is without further user action, the medication contents of the syringe through the needle, after which the syringe is retracted automatically such that the needle is returned to within the housing. The innovation disclosed herein may be applicable to other kinds of devices, such as variable disposable or reusable pen devices, multi-fixed dose disposable or reusable devices, large bolus injectors, syringes, electronic injection devices, and the like.

[0031] It will be appreciated from the following description that device 20 is conceptually similar in various aspects to the devices disclosed in U.S. Patent No. 8,734,394, filed February 24, 2011, U.S. Patent No. 9,872,961, filed October 11, 2013, and U.S. PatentNo. 11,298,462, filed March 6, 2020, the disclosures of which are incoiporated by reference herein in their entireties.

[0032] In the illustrative embodiment shown in FIG. 1, device 20 includes an outer housing 22 disposed along the longitudinal axis AA, in which are operationally disposed working components of the device. The outer housing 22 may include a sleeve 26 and a main body 24 that may together form the axial height of the outer housing. Sleeve 26 may be rotatable relative to the main body 24 by the user. The sleeve may include a protruding fin 93 to facilitate rotation by a user. The device may include a button 25 that is part of the trigger assembly and that protmdes in the axial direction from the proximal end 27 of the housing. In some embodiments, when properly rotationally oriented by rotation of sleeve 26, the button 25 is unlocked such that the button can be depressed in the distal direction to start the automatic injection function of device 20. As used herein, distal and proximal refer to axial locations relative to an injection site when the device is oriented for use at such site, whereby, for example, distal end of the housing refers to the housing end that is closest to such injection site.

[0033] Button 25 may be molded as a single piece from a suitably durable material, such as Lustran ABS 348. As further shown in the illustrative embodiment of FIG. 3, button 25 may include a disc 35 with a skirt 37 extending distally from the outer periphery of disc 35. End disc 35 may have a flat proximal face 38 upon which a force can be directly applied by a user to selectively plunge the button to trigger the device. A notch 40 may be formed in skirt 37 at the distal end of the skirt 37, and may extend axially and form a slot which receives a rib of sleeve 26 so as to rotatably key together the button 25 and sleeve 26. A set of three equally angularly spaced resilient fingers 42 that may each be provided with a detent on its radially inward face may be provided at the base of skirt 37 for locating the button 25 on a shuttle 200. Each finger 42 may be adjacent to one of three equally angularly spaced fingers 46 with inwardly angled stops 48 also provided in skirt 37 for attachment to shuttle 200.

[0034] Tapered flange portion 52 may have a sloped surface that serves as an actuating element of the trigger which cams a prong of the trigger to unlatch it for the trigger assembly. Differently designed actuating elements, including one that is not ramp shaped, can be used to cam and thereby unlatch the prong in alternate embodiments.

[0035] In some embodiments, device 20 includes a medication-filled syringe. As shown in FIG. 2, the syringe, generally designated 130, includes a barrel 132 with a flange 133, and an injection needle 134 mounted at the distal end of the barrel and in fluidcommunication with the medication contents of the barrel. Although needle 134 is shown as a single needle and is generally expected to be sized for subcutaneous delivery, with adaptions the device could be equipped with a needle of various sizes or types known in the art, including, but not limited to, a needle formed of one or more shortened injection needles, including microneedle arrays, and which needle allows for injection at different depths, such as intradermal.

[0036] Device 20 in general, and more particularly the technology claimed in this application, may be utilized in injecting a variety of medications or therapeutics into a person in need thereof. Syringes of the devices or claimed technology can be filled with any of a number of therapeutics. Device 20 may further comprise a medication, such as for example, within a reservoir within barrel 132 of syringe body or cartridge. In another embodiment, a system may comprise one or more devices including device and a medication. Such medications may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide or retatrutide, basal insulins, such insulin efsitora alfa, oxyntomodulin analogs, oxyntomodulin derivatives, and other treatments for diabetes and / or obesity, such as with lepodisiran (LPA siRNA), volenrelaxin, amylin agonist long acting, PNPLA3 siRNA, APOC3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonist, nisotirostide, bimagrunab, NRG4 agonist, SCAP siRNA, mazdutide, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab that can be used for treatment of Crohn’s disease or ulcerative colitis, IL-17 antibody analogs or derivatives, such as ixekizumab that can be used for treatment of plaque psoriasis, IL-13 antibody analogs or derivatives, such as lebrikizumab that can be used for treatment of atopic dermatitis, therapeutic agents for pain-related and / or migraine treatments, such as galcanezumab or lasmiditan, or for treatment of atopic dermatitis, such as with lebrikizumab ucenprubart, for treatment of Alzheimer’s and / or dementia, such as with donanemab, remtemetug, or GRN gene therapy, for treatment of Parkinson’s disease and / or Gaucher’s disease, such as with GBA1 gene therapy, for treatment of Hi dradenitis Suppurativa, such as with eltrekibart, for treatment of rheumatoid arthritis, such as with peresolimab, and any therapeutic agent, such as with CD 19, that is capable of delivery by the devices described herein. Devices according to the present disclosure may beoperated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user).

[0037] The plunger mechanism may include a plunger element, generally designated 136, and an elastomeric sealing member or piston 138 that seals the medication within barrel 132.

[0038] Plunger element 136 may be molded as a single piece of a lightweight but sturdy and sufficiently resilient material, such as DELRIN 311DP from Dupont Engineering Polymers. As further shown in FIG. 4A, plunger element 136 includes a cylindrical foot 140 which may be hollowed so as to have a cruciform center 142. The distal face 144 of foot 140 operationally abuts piston 138 during plunger advancement. A ribbed bar 146 may rigidly or inflexibly extend axially upward from the top of foot 140 to a disc-shaped flange 150 that has a larger diameter than foot 140. A plunger arm 152 may be formed on the outer radial periphery of flange 150 and may extend axially and distally from flange 150 in spaced relationship with plunger bar 146.

[0039] Four equally angularly spaced bosses 153 may upwardly project from the flange 150. Bosses 153 may aid in centering the drive coil spring 155 shown in FIG. 2 that acts on flange 150 to bias plunger element 136 distally within device 20.

[0040] Plunger element 136 may include a resilient prong, generally designated 160, that serves as part of the trigger assembly. The single prong 160 may latchably engage the shuttle, such as the proximal shuttle 202, in the shown embodiment until released by the plunging of button 25, which release allows the spring 155 to bias the plunger element 136 distally to result in needle insertion and injection. In some embodiments, the plunger element 136 includes one and only one resilient prong. In other embodiments, however, the plunger element 136 may include more than one resilient prong.

[0041] Prong 160 may include an upstanding, tapering finger 162 that projects axially from the center of flange 150 so as to be centered on the axis AA of the housing 22. Finger 162 may be flexible due to its construction to allow its bending movement when the prong is acted on for its release. As shown in FIG. 4B, prong 160 may include a triangular projection 165 centered on the side-to-side width of finger 162. Projection 165 may include a ramp surface 167 extending proximally and at an angle inward from the tip 169 of the projection167 extends from tip 169 to a proximal end 168. The distal face 170 of projection 165, which face does not serve a latching function, is transverse to the axial direction.

[0042] A pair of latching surfaces 172 may be provided on the proximal -most portions 171 of extensions 174 of finger 162. Latching surfaces 172 and extensions 174 flank either side of projection 165 and are spaced radially inward from the ramp surface 167 at the height of the latching surfaces along prong 160. Latching surfaces 172 are provided generally in axial alignment with finger 162 and each may be formed with a slight undercut so as to slope slightly distally as it extends in the radial direction toward ramp surface 167. Latching surfaces 172 are disposed at a height between the axial extent of ramp surface 167, such as near the proximal end 168. In this location, the contacting forces on the ramp surface may tend to produce a translational deflection of the latching element which may have a lower and more consistent unlatching force than would a rocking or pivoting motion, caused by the latching surfaces being substantially above or below the ramp surface, that would introduce extra deformation of prong 160 and make the unlatching motion less smooth.

[0043] The back surface of projection 165 may jut rearward beyond extensions 174 to define a safety protuberance 178. Protuberance may be backed up by safety arm 72 when button 25 is in its locked orientation.

[0044] As described herein, in some embodiments, device 20 includes a mechanism for providing feedback to an operator during an injection event. In some embodiments, the feedback mechanism includes a plurality of teeth and a clicker protrusion configured to engage the plurality of teeth, thereby producing auditory feedback (e.g., clicks). For example, in some embodiments, the clicker protrusion is fixed along plunger element 136 and configured to engage the plurality of teeth during plunger advancement. For example, as described herein including at least with respect to FIGs. 13A and 13B, the teeth may be formed along the shuttle of device 20 that forms a part of the clicker embodiment, and the clicker protrusion may engage the teeth as the plunger element moves through the shuttle during plunger advancement. In some embodiments, the clicker protrusion is disposed along the proximal surface of the syringe carrier or integrated into the syringe earner and the plurality of teeth are disposed along the plunger element, as shown in FIGs. 16 and 17.1n some embodiments, the clicker protrusion is fixed along plunger arm 152. FIGs. 5A-5C show example clicker embodiments having a clicker protrusion fixed along a plunger arm.

[0045] As shown in the embodiment of FIG. 5 A, the clicker protrusion 154a is fixed along an outer surface of plunger arm 152a and extends radially outward relative to theplunger element 136. In some embodiments, the clicker protrusion 154a is fixed along a bar 156a that forms part of the plunger arm 152a. In some embodiments, the bar 156a deflects independently from the rest of the plunger arm 152a. For example, when the clicker protrusion 154a engages a tooth formed in the shuttle (e.g., the teeth shown in FIG. 13A), the bar 156a may deflect relative to the rest of the plunger arm 152a to define a clicker embodiment.

[0046] As shown in the embodiment of FIG. 5B, the clicker protrusion 154b is fixed along a lateral surface of plunger arm 152b and extends tangentially relative to the plunger element 136. In some embodiments, the clicker protrusion is fixed along a bar 156b that forms part of the plunger arm 152b. In some embodiments, the bar 156b deflects independently from the rest of the plunger ami 152b. For example, when the clicker protrusion 154b engages a tooth in the shuttle (e.g., the teeth shown in FIG. 13B), the bar 156b may deflect relative to the rest of the plunger arm 152b. In another embodiment, the clicker protrusion 154b can be fixed along a lateral surface at the distal end of plunger arm 152b and extend tangentially relative to the plunger element 136 to define a clicker embodiment.

[0047] As shown in the embodiment of FIG. 5C, the clicker protrusion 154c is fixed along an outer surface of plunger arm 152c and extends radially outward relative to the plunger element 136. Although the clicker protrusion 154c is shown at the distal end of the plunge arm 152c, the clicker protrusion 154c can be disposed along any part of the surface of the plunger arm. In this embodiment, the clicker protrusion 154c may be fixed directly along plunger ami 152c, rather than along a deflectable bar that forms part of the plunger arm 152c. In some embodiments, the plunger arm 152c is configured to deflect relative to the plunger element 136 when the clicker protrusion 154c engages a tooth in the shuttle (e.g., the teeth shown in FIG. 13 A) to define a clicker embodiment.

[0048] In some embodiments, the clicker protrusion is fixed along a portion of the plunger element 136 other than the plunger arm 152. For example, the clicker protmsion may be fixed along flange 150. FIG. 5D shows an example embodiment of a clicker protmsion 154d fixed along the flange 150a. As shown in FIG 5D, the clicker protmsion 154d extends radially outward relative to the plunger element 136, beyond the perimeter of the flange 150a, such that the clicker protmsion 154 is configured to engage a plurality of teeth in the shuttle (e.g., the teeth shown in FIG. 13A) as the plunger element 136 moves through the shuttle(s) to define a clicker embodiment. The plunger arm 152d may be spaced radially from theclicker protrusion 154d. In one example, the radial spacing between the plunger arm 152d and the clicker protrusion 154d can be 90 degrees (as shown) or 180 degrees or anywhere between 5 to 180 degrees.

[0049] An assembly including the plunger element 136, syringe carrier 185, and syringe 130 is shown in FIG. 6A. The plunger bar 146 of the plunger element 136 extends through an opening 158 in the syringe carrier 185 and into the syringe carrier. As shown in FIGs. 6B and 6C, in which one part of the syringe carrier is hidden from view, the syringe carrier encloses a radial flange 133 of the syringe 130. As also seen in FIGs. 6B and 6C, the syringe carrier also encloses the foot 140 of the plunger element.

[0050] In some embodiments, device 20 includes the shuttle 200, examples of which are described herein including at least with respect to FIG. 7 and FIGs. 8A-8E. In some embodiments, the shuttle 202 or 204 is positioned within housing 22 of device 20. In some embodiments, the shuttle 202 or 204 forms a hollow tube having a proximal surface having a first opening, a distal surface having a second opening, and walls extending between the proximal and distal surfaces. In some embodiments, an outer face of the proximal surface, such as, e.g., the proximal shuttle 202, provides a shelf for the trigger assembly until an injection event is triggered. In some embodiments, an inner face of the proximal surface, such as, e.g., the proximal shuttle 202, provides a contact surface for the drive coil spring 155. For example, the drive coil spring 155 may be housed within the shuttle. As described herein, including at least with respect to FIGs. 13A-13B, the shuttle 202 or 204 may additionally include teeth that form part of a feedback mechanism. The principles of the disclosure can be applied to different device architectures where a linear plunger is driving through and relative to a shuttle tube within the device housing.

[0051] Device 20 may have a delay mechanism that includes the shuttle, generally designated 20, a follower 250 that releasably latches with the shuttle 200, and a dual functioning biasing member 275 acting between the shuttle and the follower. Shuttle 200 may be formed of a proximal shuttle 202 and a distal shuttle 204 further shown in FIG. 7 and FIGs. 8A-8E, respectively, that are fixedly connected during manufacturing assembly. The interaction between the proximal shuttle 202 and the distal shuttle 204, as well as the features of the proximal shuttle 202 are described in greater detail in U.S. Patent No. 9,872,961.

[0052] Distal shuttle 204 includes distal region 270, and the flange 272 that transitions from body 210 to region 270 is designed to engage syringe carrier 185. When the distal shuttle 204 is moved proximally during retraction, the flange 272 abuts against a distalsurface of the syringe carrier 185, thus moving the syringe carrier 185 and syringe barrel 132 in the proximal direction with proximal movement of the distal shuttle 204. Groove 280 in distal shuttle body 210 receives a housing key to rotatably fix shuttle 200 with a cavity in sleeve 26.

[0053] Tabs 282 and 284 radially project from distal region 270 and serve as latching elements or hooks to engage the follower. Notch 286 that leads to pocket 288 within tab 282 receives a proximal projection 289 of the biasing member 275.

[0054] An angled, locking latch surface 290 is disposed distally of an opening 292 in line with an axially extending channel 294 formed in the interior surface of distal shuttle body 210. Channel 294 accommodates plunger arm 152 that can project through opening 292 to unlock the locking mechanism described below.

[0055] Follower 250 is further shown in FIGs. 9A-9E and includes a proximal portion 298 with ledges 300 and 302 that serve as latching elements that engage shuttle latching tabs 282 and 284. Channel 304 and opening 306 in proximal portion 298 allow axial movement of tabs 282 and 284 therein for manufacturing assembly and for shuttle release relative to the follower during device use. Opening 306 tapers to a slot-shaped portion 310 adapted to closely receive a radial projection 312 of biasing member 275.

[0056] A radially projecting flange 316 may snap past snaps in the main body 24 during device assembly. The interior surface of follower portion 298 includes an inwardly projecting ring 318 with a spring centering lip 320. A sleeve shaped distal portion 322 of follower 250 extends from follower portion 298 and has a lesser diameter. Slots 324 in the distal edge of portion 322 define four damping fins 326 of the follower. The slots 324 can be adjusted in size to create to differing delay times. A locking member for follower 250 to limit its rotation relative to the shuttle 200 is formed as a flexure arm 330 with an upwardly extending latch 332 at its end.

[0057] An exploded view of the distal shuttle 204, biasing member 275, and follower 250 is shown in FIG. 11. Biasing member 275 may function as both a torsion spring and a compression spring, with torsional preloading and an axial preloading accomplished during the manufacturing assembly of device 20. Biasing member 275 is shown as a cylindrical spring formed of a helically coiled wire 311, with a shuttle engaging tip in the form of a proximal projection 289, and a follow engaging tip 312.

[0058] An assembly of the distal shuttle 204 and follower 250 shown in a coupled configuration is shown in FIGs. 10A and 10B. In the coupled configuration, the latch 332 of the follower is engaged with a protrusion 213 on a distal surface 211 of the distal shuttle 204.

[0059] As shown in FIGs. 12A and 12B, the distal surface 211 of the distal shuttle 204 has an undercut region 215 adjacent to the protrusion 213. The undercut region has a curvilinear shape.

[0060] As shown in FIG. 9D, the latch 332 of the follower is axially moveable relative to the follower body 251 due to cantilevered flexure arm 330, which is able to deflect relative to the follower body. The latch 332 may be comprised of a leading surface 333 and a trailing surface 335. The leading surface 333 engages with the protrusion 213 when the follower is in the coupled configuration in FIG. 10B. The trailing surface 335 may slidingly engage with the undercut region 215 when the follower is in an uncoupled configuration and is rotating relative to the distal shuttle 204. In the uncoupled configuration, the latch 332 is disengaged with the protrusion 213. In some embodiments, the leading surface 333 may be a flat surface that engages in a confronting relationship a flat surface portion 214 of the protrusion 213. At least one, or both, of the leading surface 333 and flat surface portion 214, may be angled slightly to facilitate latching with and / or uncoupling from the protrusion 213. In some embodiments, the trailing surface 335 may be curved to facilitate uncoupling of the latch from the protrusion, and / or facilitate sliding engagement with the undercut region 215.

[0061] Distal shuttle 204 may include a lubricant-infused material to aid in the movement of the distal shuttle 204 within the device housing, particularly during the needle retraction operation. In one example, the entire distal shuttle includes lubricant-infused material. In some embodiments, at least the distal surface 211 of the distal shuttle is made of a lubricant-infused material. Such a material may aid in facilitating uncoupling of the latch 332 from the protrusion 213 and / or facilitating sliding engagement between the latch 332 and the undercut region 215 as the follower 250 rotates relative to the distal shuttle. In some embodiments, the lubricant-infused material may serve to decrease friction and / or friction variability between the distal shuttle and the latch during movement of the follower relative to the distal shuttle. The lubricant-infused material may also serve to lower friction and / or friction variability between the tabs 282, 284 with the ledges 300, 302. In some embodiments, the material may be a silicone-infused material. In some embodiments, the material may be made of polycarbonate with infused silicone of 2%. In some embodiments, all of or at least aportion of the follower 250 may be made of a copolymer to decrease friction and / or friction variability between the distal shuttle and the follower.

[0062] In some embodiments, teeth are formed between the proximal end and the distal end of at least a portion of a shuttle (e.g., shuttle 202 or 204). As described herein, in some embodiments, a clicker protrusion (e.g., the clicker protrusion 154a, 154b, and 154c shown in FIGs. 5A-5D) is configured to engage the teeth as the plunger element 136 moves through the shuttle (e.g., between the proximal end and the distal end) during an injection event.

[0063] FIG. 13A and FIG. 13B show example embodiments of teeth disposed along shuttle 1300. As shown in the embodiment of FIG. 13 A, the shuttle 1300a includes teeth 1306a disposed along the surface 1302a of the shuttle 1300a. Shuttle 1300a, 1300b is shown configured similarly to the distal shuttle 204 with teeth. Shuttle 1300a, 1300b may be configured similarly to the proximal shuttle 202 having teeth disposed in the arrangement shown in FIGs. 13A-13B. The teeth 1306a may be configured to engage a clicker protrusion that extends radially outward relative to the plunger element 136. For example, the teeth 1306a may be configured to engage the clicker protrusion 154a shown in FIG. 5 A, the clicker protrusion 154c shown in FIG. 5C, or the clicker protrusion 154d shown in FIG. 5D. By contrast, as shown in the embodiment of FIG. 13B, the shuttle 1300b includes teeth 1306b disposed along groove portion(s) 1308 formed in the surface of the shuttle 1300b. As shown in FIG. 13B, the groove portion(s) 1308 have a lateral surface that joins the surface 1302b at an angle. For example, the lateral surface may be substantially perpendicular to surface 1302b. Due to the positioning of the teeth 1306b along the lateral surface of groove portion(s) 1308, the teeth 1306b may be configured to engage a clicker protrusion that extends tangentially relative to the plunger element 136. For example, the teeth 1306b may be configured to engage the clicker protrusion 154b shown in FIG. 5B.As shown in the embodiments of FIG. 13A and FIG. 13B, the teeth may be defined by a plurality of openings formed in the shuttle wall. In some embodiments, as the plunger element 136 moves through the shuttle, the clicker protrusion engages a tooth by extending at least partially into the opening corresponding to the tooth. In some embodiments, when the clicker protrusion passes over a region separating the teeth, the plunger arm 152 or the bar (e.g., bar 156a or 156b) along which the clicker protrusion is fixed deflects relative to the plunger element 136.

[0064] Though not shown, in an alternative embodiment, the teeth may comprise a plurality of protrusions disposed along an inner surface of the shuttle 1300. In someembodiments, as the plunger element 136 moves through the distal or proximal shuttle the clicker protrusion engages a tooth by sliding over the protrusion corresponding to the tooth. In some embodiments, when the clicker protrusion passes over a tooth, the plunger arm 152 or the bar (e.g., bar 156a or 156b) along which the clicker protrusion is fixed deflects relative to the plunger element 136.

[0065] The construction of device 20 will be further understood in view of a description of one illustrative embodiment of its operation after the end cap is removed in preparation for an injection. To arrange device 20 to inject, sleeve 26, and thereby button 25, is manually rotated by a user to an unlocked state in which the device is ready to inject.

[0066] A cross-sectional view of the device in the unlocked state is shown in FIG. 14. When a user subsequently applies a distal force on button 25, button 25 starts to move downward into sleeve 26, thereby driving flange surface 54 against ramp surface 167. As button 25 continues to move further distally, with flange portion 52 inserting further into the shuttle opening, flange surface 54 slides along ramp surface 167. During this sliding, flange portion 52 cams prong 160 radially outward because flange portion 52 is prevented from bending in the opposite radially outward direction due to the contact with the supportive collar surface 234. Flange portion 52 is prevented from twisting due to contact with supportive surfaces 203 on the proximal shuttle 202. Prong 160 can be cammed outward as finger 162 bends until latching surfaces 172 disengage from latch surfaces on the proximal shuttle, at which point the proximal-most portion of plunger prong 160 passes downward through the shuttle due to spring 155 directly biasing the plunger element 136 downward to drive the plunger element and thereby the piston 138 distally, which driven motion shifts syringe barrel 132 and syringe carrier 185 distally relative to the shuttle and the housing to cause the tip of needle 134 to project beyond the housing distal end for penetrating a user's skin, and then forces the medication contents of the syringe through that needle for an injection.

[0067] As plunger element 136 moves distally during medication injection, the clicker protrusion (e.g., clicker protrusion 154a, 154b, 154c shown in FIGs. 5A-5C) engages a plurality of teeth (e.g., teeth 1306a, 1306b shown in FIGs. 13A-13B). In some embodiments, the teeth are arranged linearly between a proximal end and a distal end of at least a portion of the shuttle, and the clicker protrusion may engage the teeth sequentially as the plunger element 136 moves between the proximal and the distal end of the shuttle. In such an embodiment, the clicker protrusion may be configured to engage a first tooth beforeengaging a second tooth that is positioned distally relative to the first tooth. In some embodiments, when the clicker protrusion engages the plurality of teeth, an audible sound is produced. For example, a sound (e.g., a click) may be produced each time the clicker protrusion passes over a tooth. The arrangement of the teeth (shape, size, relative spacing) may be configured to generate a constant click sound frequency (such as, for example, one per second, or faster or slower) and number of click sounds. In other embodiments, the arrangement of the teeth (shape, size, relative spacing) may be configured to generate a steadily increasing or a decreasing click sound frequency and number of click sounds. The speeding up or slowing down of clicking sounds at the end of the injection approaches may be readily indicate to an operator as the nearing of an end of a process. The materials and / or thickness of the clicker protrusion or the plunger arm may be selected to produce louder clicks.

[0068] Furthermore, as the plunger element 136 moves distally during medication injection and after the clicker protrusion engages the plurality of teeth positioned along at least the portion of the shuttle, the arm 152 abuts against the latch 332 of the follower 250, causing flexure arm 330 to deflect distally, causing the leading surface 333 of the latch to slide distally past the protrusion 213 of the distal shuttle 204, thus causing the latch 332 to clear the protrusion 213. With the latch 332 disengaged from the protrusion 213 of the distal shuttle 204, the follower 250 is in the uncoupled configuration, and the follower 250 is thus unlocked for rotation relative to the distal shuttle 204. FIG. 15 shows the arrangement of device 20 at this point of the use process.

[0069] Follower 250, as urged by the torsional preloading of biasing member 275, rotates against the damping effect of damping compound 350, during which rotation remaining medication can be properly expelled from the syringe through the needle. When follower 250 has rotated such that shuttle tabs 282 and 284 are clear of ledges 300 and 302, shuttle 200 and follower 250 are thereby unlatched so as to allow the compressively preloaded biasing member 275 to decompress, forcing shuttle 200 proximally relative to the device housing to retract the syringe carrier 185 and the syringe barrel 132 along with the syringe carrier, thereby retracting the distal tip of the injection needle 134 to a protected, retracted position within the housing 22.

[0070] FIG. 16 and FIG. 17 show other embodiments of clickers 1600, 1700, respectively, of device 20 that includes a mechanism for providing feedback to an operator during an injection event. The feedback mechanism includes a plurality of teeth and a clickerprotrusion configured to engage the plurality of teeth, thereby producing auditory feedback (e.g., clicks). For example, in some embodiments, clicker 1600 comprises the clicker protrusion 1654 that is part of a clicker body 1655 that is disposed along and proximal to at least a portion of the proximal surface 1685 a of syringe carrier 1685 and configured to engage the plurality of teeth 1699 disposed along the body of plunger element 1636 during plunger advancement, as shown in FIG. 16. In some embodiments, the clicker protrusion 1754b of clicker 1700 is coupled and integrated into syringe carrier 1785 and configured to engage the plurality of teeth 1799 disposed along the body of plunger element 1736 during plunger advancement, as shown in FIG. 17. Each of these approaches can avoid the issues by adding a part as part of the process for wet side assembly of the syringe for the device.

[0071] Clicker body 1655 defines includes a pair of winged portions 1657a,b extending circumferentially with respect to clicker protrusion 1654, which is centrally located and extending radially inward toward the axis AA. Winged portions 1657a,b are sized and shaped to surround the lateral sides of plunger element 1636. Finger elements 1659 may be provided at the end of winged portions 1657a,b to capture the opposite ends of plunger element 1636 with clicker body 1655 along at least three points of contact - each of the fingers 1659 and the tip of clicker protrusion 1654. Clicker body 1655 can be made of plastic or metal. The tip of clicker protrusion 1654 that engages the teeth 1699 may be chamfered. Clicker body 1655 may be disposed generally along a common plane. In some embodiments, portions of clicker body 1655 may be elevated from proximal surface 1685a. For example, the portion of clicker body 1655 with clicker protrusion 1654 may be disposed along a plane different (e.g., by 1 mm elevation) than the plane defined along which the winged portions 1657a,b are disposed. This may provide for more axial deflection of the clicker protrusion for a more desirable sound. A standoff element can be added to the elevated body portion for support along the proximal surface. In another embodiment, the entire clicker body is elevated, and standoff elements are provided for support along the proximal surface. A rib may be provided along the clicker body for added stiffness.

[0072] In FIG. 17, clicker 1700 comprises the clicker body 1755 that is part of or integrated into syringe carrier 1785. Syringe carrier 1785 can include a first part 1787a and a second part 1787b that couple to one another around plunger element 1736. The clicker protrusion 1754 is coupled and integrated into first part 1787a of syringe carrier 1785, and configured to engage the plurality of teeth 1799 disposed along the body of plunger element 1736 during plunger advancement. First part 1787a includes winged portions 1757a, bsurrounding the lateral sides of plunger element 1736, with the clicker protrusion 1754b located between portions 1757a, b. As illustrated, the clicker protrusion and the winged portions are defined along a common plane, defining a portion of proximal surface 1785a of the syringe carrier 1785.

[0073] According to an embodiment of the present disclosure, an automatic injection device is provided. In some embodiments, the automatic injection device includes a container reservoir of medication including an outlet that is disposed proximally of the device housing’s distal end during injection. The syringe carrier coupled to an end of the reservoir, in some cases, the flange of a syringe, surrounding the cross-section of the plunger body. The plunger element is axially moveable relative to the device housing and the syringe carrier during the injection event. A plurality of teeth fixed along a portion of the plunger body between the proximal end and the distal end of the plunger element. The clicker protrusion fixed along the syringe carrier. The clicker protrusion is configured to engage the plurality of teeth of the plunger element as the plunger element moves during the injection event, thereby producing auditory feedback. In some embodiments, the clicker protrusion body is disposed and fixed along the proximal surface of the syringe carrier, outside the interior of the syringe carrier. In some embodiments, the clicker protrusion body is integrated into the syringe carrier. For example, a first part of the syringe carrier may include the clicker protrusion body, with the first part coupling to a second part around the reservoir end and the plunger’ s cross-section. The clicker protrusion body may define at least a portion of the proximal surface of the syringe carrier.

[0074] The arrangement of the plunger teeth (shape, size, relative spacing) along the plunger element in FIGS. 16-17 may be configured to generate a constant click sound frequency (such as, for example, one per second, or faster or slower) and number of click sounds. In other embodiments, the arrangement of the teeth (shape, size, relative spacing) along the plunger element may be configured to generate a steadily increasing or a decreasing click sound frequency and number of click sounds. The speeding up or slowing down of clicking sounds at the end of the injection approaches may be readily indicate to an operator as the nearing of an end of a process. The materials and / or thickness of or elevation of the clicker protrusion may be selected to produce louder clicks.

[0075] While the automatic injection device described herein has been shown and described as having preferred designs, the present device may be modified within the spirit and scope of this disclosure. For example, while the biased element that the trigger assemblyreleases in the shown embodiment is the plunger that itself contacts the syringe piston, the trigger assembly could be used to release different biased elements in alternate embodiments, or elements that are biased with parts different than coiled springs. This application is therefore intended to cover any variations, uses or adaptations of the device using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this automatic injection device pertains.

[0076] Having thus described several aspects of at least one embodiment of this invention, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

[0077] In some embodiments, the clicker protrusion extends radially outward relative to the plunger. In some embodiments, the clicker protrusion extends tangentially relative to the plunger.

[0078] In some embodiments, the plunger includes a main body, and a plunger arm is spaced from the main body and radially deflectable relative to the main body, wherein the clicker protrusion is fixed along the plunger aim. In some embodiments, the clicker protrusion is fixed along an outer surface of the plunger ami. In some embodiments, the clicker protrusion is fixed along a lateral surface of the plunger arm.

[0079] In some embodiments, the plurality of teeth includes a plurality of openings in the portion extending between the proximal end and the distal end of the shuttle. In some embodiments, the clicker protrusion extends at least partially into each of at least some of the plurality of openings as the plunger moves through the shuttle during the injection.

[0080] In some embodiments, the plurality of teeth includes a plurality of protrusions extending radially inward towards an axis between the proximal end and the distal end of the shuttle. In some embodiments, the clicker protrusion contacts each of at least some of the plurality of protrusions as the plunger moves through the shuttle during the injection.

[0081] In some embodiments, the plurality of teeth includes a first tooth and a second tooth fixed distally relative to the first tooth, and the clicker protrusion is configured to engage the second tooth after engaging the first tooth during the injection event. In some embodiments, a syringe barrel is disposed in the shuttle and coupled to the plunger, and thesyringe barrel is configured to hold medication. In some embodiments, the shuttle includes a lateral surface and an outer surface, and the teeth of the plurality of teeth are fixed at least partially along the lateral surface such that the teeth are contactable in a tangential direction relative to the outer surface of the shuttle.

[0082] In some embodiments, the plunger includes a flange, and the clicker protrusion extends radially outward relative to the plunger from the flange. In some embodiments, the plunger includes a main body, and a plunger arm that is spaced from the main body and radially deflectable relative to the main body, and the clicker protrusion is fixed along the plunger arm, and the plunger arm is spaced radially from the clicker protrusion.

Claims

What is claimed is:CLAIMS1. An automatic injection device, comprising:a plunger axially moveable during an injection event;a shuttle through which the plunger is moved during the injection event, the shuttle comprising:a proximal end, a distal end, and a portion extending between the proximal end and the distal end; anda plurality of teeth fixed along the portion extending between the proximal end and the distal end; anda clicker protrusion fixed along the plunger, wherein the clicker protrusion is configured to engage the plurality of teeth as the plunger moves through the shuttle during the injection event, thereby producing auditory feedback.

2. The automatic injection device of claim 1, wherein the clicker protrusion extends radially outward relative to the plunger.

3. The automatic injection device of claim 1, wherein the clicker protrusion extends tangentially relative to the plunger.

4. The automatic injection device of any of claims 1-3, wherein the plunger comprises:a main body; anda plunger ami spaced from the main body and radially deflectable relative to the main body, wherein the clicker protrusion is fixed along the plunger arm.

5. The automatic injection device of claim 4, wherein the clicker protrusion is fixed along an outer surface of the plunger arm.

6. The automatic injection device of claim 4, wherein the clicker protrusion is fixed along a lateral surface of the plunger ami.

7. The automatic injection device of any of claims 1-6, wherein the plurality of teeth comprises a plurality of openings in the portion extending between the proximal end and the distal end of the shuttle.

8. The automatic injection device of claim 7, wherein the clicker protrusion extends at least partially into each of at least some of the plurality of openings as the plunger moves through the shuttle during the injection.

9. The automatic injection device of any of claims 1-6, wherein the plurality of teeth comprises a plurality of protrusions extending radially inward towards an axis between the proximal end and the distal end of the shuttle.

10. The automatic injection device of claim 9, wherein the clicker protrusion contacts each of at least some of the plurality of protrusions as the plunger moves through the shuttle during the injection.

11. The automatic injection device of any of claims 1-10, wherein the plurality of teeth comprises a first tooth and a second tooth fixed distally relative to the first tooth, and wherein the clicker protrusion is configured to engage the second tooth after engaging the first tooth during the injection event.

12. The automatic injection device of any of claims 1-11, further comprising a syringe barrel disposed in the shuttle and coupled to the plunger, wherein the syringe barrel is configured to hold medication.

13. The automatic injection device of any of claims 1-12, wherein the shuttle includes a lateral surface and an outer surface, and wherein the teeth of the plurality of teeth are fixed at least partially along the lateral surface such that the teeth are contactable in a tangential direction relative to the outer surface of the shuttle.

14. The automatic injection device of claim 1, wherein the plunger comprises a flange, and the clicker protrusion extends radially outward relative to the plunger from the flange.

15. The automatic injection device of claim 14, wherein the plunger comprises:a main body; anda plunger arm spaced from the main body and radially deflectable relative to the main body, wherein the clicker protrusion is fixed along the plunger arm, the plunger arm spaced radially from the clicker protrusion.

16. An automatic injection device, comprising:a plunger axially moveable during an injection event, the plunger comprising a main body, and a plunger arm spaced from the main body;a shuttle through which the plunger is moved during the injection event, the shuttle comprising:a proximal end, a distal end, and a portion extending between the proximal end and the distal end; anda plurality of teeth fixed along the portion extending between the proximal end and the distal end; anda clicker protrusion fixed is fixed along the plunger arm, wherein the clicker protrusion is configured to engage the plurality of teeth as the plunger moves through the shuttle during the injection event, thereby producing auditory feedback.

17. The automatic injection device of claim 16, wherein the plurality of teeth comprises a plurality of openings in the portion extending between the proximal end and the distal end of the shuttle.

18. The automatic injection device of claim 16, further comprising a follower disposed distal to and coupled to the shuttle, wherein during movement of the plunger relative to the shuttle, the plunger arm engages an arm of the follower to initiate rotation of the follower relative to the shuttle.

19. A method of auditory feedback to a user of a medication delivery device, the medication delivery device including a plunger, a shuttle through which the plunger is moved during an injection event, the shuttle including a proximal end, a distal end, and a portion extending between the proximal end and the distal end, and a plurality of teeth fixed alongthe portion extending between the proximal end and the distal end, and a clicker protrusion fixed along the plunger, the method comprising the steps of:actuating the plunger to axially move relative to the shuttle during the injection event; andenabling the engagement of the clicker protrusion of the plunger with the plurality of teeth of the shuttle as the plunger is axially moved relative to the shuttle, thereby producing auditory feedback during the injection event.

20. The method of claim 19, wherein the plunger comprises a main body, and a plunger arm spaced from the main body and radially deflectable relative to the main body, wherein the clicker protrusion is fixed along the plunger arm, and the plurality of teeth comprises a plurality of openings in the portion extending between the proximal end and the distal end of the shuttle.

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