Visual indicator(s) for status of medication delivery devices

Abstract

What is disclosed is a medication delivery device and methods of use thereof to provide visual indication of a completion of an injection event. The device can have a container retraction mechanism coupled to a medication container, such as a prefilled syringe, by which when triggered the container is retracted distally within the housing after the medication is forced from the container outlet. The container retraction mechanism includes one or more retraction component(s) that facilitate the retraction process. The retraction component can stop at a start of retraction or start moving during retraction. One or more windows are provided along the housing, such as, being formed by a label. The container and / or the retraction component includes a visual indicator that is visual through the window as indication of a completion of injection. The window may be distal to the visual indicator prior to the retraction process.

Description

VISUAL INDICATOR(s) FOR STATUS OF MEDICATION DELIVERY DEVICESFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to a medication delivery device and method for providing visible information as to use of such injection device. More particularly, the present disclosure relates to improvements of visible information to the user as indication of a complete injection.BACKGROUND OF THE DISCLOSURE

[0002] Patients suffering from a number of different diseases frequently must inject themselves with medications. A variety of devices have been proposed to facilitate these injections. One type of device is an automatic medication injection device. This type of device typically includes a trigger that when operated by a user causes the device to automatically insert into the user a needle of a syringe that prior to triggering was disposed within the device housing, and then the device automatically injects a dose of medication through that inserted needle. In some cases, an automatic injection device does not so insert the needle into the user, but does, when triggered, automatically inject a dose of medication through the needle that has been manually inserted by the user.

[0003] One potential shortcoming with using automatic injection devices relates to the fact that some users may be unsure they are using the devices correctly. Without some sort of feedback from the device when it is being used, a user may question whether an injection has commenced or whether it is finished. Uncertainty in the user about an injection being completed is particularly likely in cases where the injection takes a relatively long time to complete, possibly such as due to a large volume dose or a high viscosity dose of medication being delivered.

[0004] Therefore, a need exists for methods and devices with a visual indicator which can overcome one or more of these and other shortcomings of the prior art.SUMMARY

[0005] According to an exemplary embodiment of the present disclosure, a medication delivery device is provided including a housing having a length extending in an axial direction between a proximal end and a distal end, and a container of medication including an outlet that is placeable proximally of the housing proximal end at least during aninjection event. The container includes a container housing and a sealing plunger. The sealing plunger is in sealing engagement with the container housing. A drive mechanism is within the housing and is configured to advance the sealing plunger proximally within the container to force medication from the container outlet during an injection event. A container retraction mechanism is coupled to the container. When triggered, the container is retracted distally within the housing after the medication is forced from the container outlet. The container retraction mechanism includes a retraction component configured to stop moving or start moving at a start of retraction. A window is formed along the housing. The container or the retraction component includes a visual indicator that is visible through the window as indication of a completion of the injection event.

[0006] According to another exemplary embodiment of the present disclosure, a medication delivery device is provided including a housing having a length extending in an axial direction between a proximal end and a distal end, and a syringe of medication including a needle that is placeahle proximally of the housing proximal end at least during an injection event. The syringe includes a syringe barrel and a sealing plunger that is in sealing engagement with the syringe barrel. A drive mechanism is within the housing and is configured to advance the sealing plunger proximally within the syringe barrel to force medication from the syringe needle during the injection event. A syringe retraction mechanism is coupled to the syringe. When triggered, the syringe is retracted distally within the housing after the medication is forced from the syringe needle. The syringe retraction mechanism includes a retraction component configured to move distally and stop. The window is formed along the housing. The retraction component includes a visual indicator that is not visible through the window prior to the injection event and is visible through the window as indication of a completion of the injection event.

[0007] According to another exemplary embodiment of the present disclosure, a method of treatment of a disease with a medication delivery device is provided. The method including: providing a medication delivery device. The medication delivery device includes a housing having a length extending in an axial direction between a proximal end and a distal end, a container of medication including an outlet that is placeable proximally of the housing proximal end at least during an injection event. The container includes a container housing and a sealing plunger that is in sealing engagement with the container housing. A drive mechanism is within the housing and is configured to advance the sealing plunger proximally within the container to force medication from the container outlet during the injection event.A container retraction mechanism is coupled to the container. When triggered, the container is retracted distally within the housing after the medication is forced from the container outlet. The container retraction mechanism includes a retraction component configured to stop or move at a start of retraction. A window is formed along the housing. The container or the retraction component includes a visual indicator that is not visible through the window in a first state of device operation, and is visible through the window in a second state of device operation. The method further includes placing the outlet of the medication delivery device a treatment site, where the visual indicator is not visible. The method further includes actuating the medication delivery device to inject the medication from the medication delivery device to treatment site, where the visual indicator is visible through the window. The method may include the step of removing the medication delivery device from the treatment site. The visual indicator is positioned after having moved distally away from the outlet to align with the window.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0009] FIG. 1 a is a schematic of a medication delivery device with an embodiment of a visual injection status indicator of the present disclosure;

[0010] FIG. lb is a schematic of a medication delivery device with another embodiment of the visual injection status indicator of the present disclosure;

[0011] FIG. 2a is a side view of a medication delivery device with an another embodiment of the visual injection status indicator of the present disclosure;

[0012] FIG. 2b is a longitudinal cross-sectional view of the medication delivery device of FIG. 2a;

[0013] FIGS. 3a and 3b are respectively perspective and longitudinal cross-sectional views of a main housing body of the apparatus of FIG. 2a shown separate from the other apparatus components;

[0014] FIGS. 4a, 4b and 4c are respectively perspective, bottom perspective, and longitudinal cross-sectional views of a housing baseplate of the apparatus of FIG. 2a shown separate from the other apparatus components;

[0015] FIGS. 5a, 5b, 5c and 5d are respectively perspective, bottom perspective, top and longitudinal cross-sectional views of a housing safety sleeve of the apparatus of FIG. 2a shown separate from the other apparatus components;

[0016] FIGS. 6a, 6b, 6c, 6d and 6e are respectively perspective, side, first longitudinal cross-sectional, bottom perspective and second longitudinal cross-sectional views of a button shown separate from the other apparatus components;

[0017] FIGS. 7a, 7b, 7c, and 7d are respectively two perspective, side and top views of a plunger element shown separate from the other apparatus components;

[0018] FIGS. 8a, 8b and 8c are respectively perspective, bottom perspective and top views of a syringe carriage shown separate from the other apparatus components;

[0019] FIG. 8d is a top view similar to that of FIG. 8c but prior to the syringe carriage being overmolded;

[0020] FIGS. 9a, 9b, 9c, 9d and 9e are respectively perspective, first side, second side, longitudinal cross-sectional, and bottom perspective views of an upper shuttle part shown separate from the other apparatus components;

[0021] FIGS. 10a, 10b, 10c, lOd and lOe are respectively perspective, first side, second side, longitudinal cross-sectional, and bottom views of a lower shuttle part shown separate from the other apparatus components;

[0022] FIGS. Ila, l ib, 11c, l id and l ie are respectively first perspective, first side, second perspective, second side and longitudinal cross-sectional views of a follower shown separate from the other apparatus components;

[0023] FIGS. 12a, 12b and 12c are respectively perspective, side and top views of a dual functioning biasing member in an unstressed or not preloaded state shown separate from the other apparatus components;

[0024] FIGS. 13a, 13b, 13c and 13d are respectively perspective, side, longitudinal cross-sectional and top views of a grease collar shown separate from the other apparatus components;

[0025] FIGS. 14-19 are longitudinal cross-sectional views of the medication delivery device of FIG. 2a at subsequent stages of its operation;

[0026] FIGS. 20-21 are front views, showing different states of the medication delivery device with one embodiment of the visual injection status indicator of the present disclosure; and

[0027] FIGS. 22-23 are front views, showing different states of the medication delivery device with another embodiment of the visual injection status indicator of the present disclosure; and

[0028] FIGS. 24-25 are front views, showing different states of the medication delivery device with another embodiment of the visual injection status indicator of the present disclosure;

[0029] FIGS. 26-27 are front views, showing different states of the medication delivery device with another embodiment of the visual injection status indicator of the present disclosure; and

[0030] FIG. 28 is a flow diagram of an embodiment of a method of operating the medication delivery device at a treatment site.

[0031] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.DETAILED DESCRIPTION

[0032] Certain medication delivery devices include components that move during the operation of an injection event. Some components may move prior to or during injection of a medication, while other components may move after the injection of medication, which together define the injection event to permit the user to lift-off the device. One example is a retraction mechanism to retract the drug container within the device housing after the delivery of a medication. These devices could be any medication delivery device, such as, for example, an automatic injection device, such as one provided by Eli Lilly and Company, that includes a pre-filled syringe, or an electronic autoinjector device that may include a pre-filled syringe, a drug cartridge, or other alternative drug container. Indication of operation status of these medication delivery devices before, during, and / or after an injection of medication maybe beneficial to the user, e.g., by alleviating user uncertainty regarding injection status or completion of injection, and / or by preventing (or reducing frequency of) premature lift-off of the device from the injection site.

[0033] In some embodiments, a medication delivery device with a retraction mechanism may provide a true indication of the completion of an injection. In some devices, the device is designed to retract the drug container and thus remove the needle from the injection site (or hides the needle within the device housing) automatically prior to the user lifting off the device from the treatment site. This disclosure provides adding a visual injection status indicator to a medication delivery device. The indicator is visible at least partially around, and in some examples the entire, circumference or perimeter of the device to indicate completion of medication delivery to the user. In one example, a visual indicator, such as, for example, a segment of color, is provided on a retraction component, and a window is formed along the device housing, such as, for example, a window formed in the device housing or by a label affixed to the device. The window is configured to allow visibility to a component that is internal to the device housing. Before the drug container is retracted, the visual indicator may not be aligned with the window, such that the indicator is not visible to the user through the window. After an injection event, the window and the visual indicator are aligned after retraction of the drug container is complete, whereby the user can see that the window is at least partially filled by the visual indicator that is internal to the device housing. In one example, the window may be filled by a first visual indicator for a first state of a plurality of states of the device operation, such as, for example, (i) prior to the delivery of the medication, (ii) during the delivery of medication, or (iii) at the end of the delivery medication. The window may be filled by a second visual indicator, that is different than the first visual indicator, for a second state of the device operation, such as, for example, after the injection event (i.e., after medication delivery and after syringe retraction). The visual indicators described herein may be colors, graphical images, text or symbols. The visual indicators may also be used to indicate the injection status prior to the retraction of the drug container, instead of or in addition to the retraction status. In some examples, the retraction component may be utilized as part of the injection operation prior to the retraction operation, and in some cases may be indicative of the end of injection and / or the start of the retraction. To this end, the user may be given two operational states of the device, that is, the end of the drug delivery through the needle (with or without a delay prior to retraction) and the end of the retraction state. With this information, the user can have more confidence to liftoff the medication delivery device from the treatment site. This may be beneficial for patients who fail to recall the number of seconds to maintain device contact with the treatment site as indicated in the instructions-for-use or for patients who require larger amounts of medication 2-5 mL or more, which typically take longer to inject the full amount.

[0034] Referring to FTG. 1 a, an embodiment of a medication delivery device 420 is shown, having a device housing 422 extending in an axial direction between a proximal end 424 and a distal end 425. A container 430 of medication, which includes an outlet 432 (shown as a needle cannula). The container 430 can be any reservoir designed to hold medication, such as, for example, a cartridge or a syringe. The outlet 432 is disposed proximally of the proximal end 424 at least during injection. The container 430 includes a container housing 435 and a sealing plunger 436. The sealing plunger 436 is in sealing engagement with an inner wall of the container housing 435. A drive mechanism 440 is disposed within the device housing 422, which is configured to advance the sealing plunger 436 proximally within the container 430 to force medication from the container outlet 432 during injection. A container retraction mechanism 450 is disposed within the device housing 422, which, when triggered, is configured to retract the container 430 within the housing 422 after the medication is forced from the container outlet 432. The container retraction mechanism 450 includes one or more retraction components 452 configured to stop to initiate the start of retraction or move at the start of retraction. A window 460 may be formed along the housing 422. Window 460 may be formed as part of the housing 422, that is, by a separate transparent component, markings printed along the housing, or defined by a label affixed to the device housing 422. The window may extend circumferentially by any number of angular degrees. In one embodiment, the window extends at least 270 degrees, or an angular distance in the range of 270 degrees to 360 degrees, that may provide a wide range of viewing for the user. The window may be divided by one or more circumferential and / or axial segments. In one example, the retraction component 452 comprises a visual indicator 470 that would be visible through the window 460 when the medication delivery device 420 is in a certain operational state, such that the visual indicator is indicative of said operational state (such as, e.g., completion of injection and / or completion of retraction). Although visual indicator 470 is not aligned with window 460 when the medication delivery device 420 is in the operational state depicted in FIG. 1 a, when the medication delivery device 420 transitions to another operational state (e.g., when the device transitions from an “injection not complete” to an “injection complete” state), the retraction component 452 may move suchthat the visual indicator 470 is aligned with, and therefore visible through, window 460. Alternatively, or in addition, the retraction component 452 comprises the container 430 that may include the visual indicator 470 that would be visible through the window 460 when the medication delivery device 420 is in a certain operational state, such that the visual indicator is indicative of said operational state (such as, e.g., completion of injection and / or completion of retraction), such as shown in FIG. lb. Again, although visual indicator 470 is not aligned with window 460 when the medication delivery device 420 is in the operational state depicted in FIG. lb, when the medication delivery device 420 transitions to another operational state (e.g., when the device transitions from an “injection not complete” to an “injection complete” state), the container 430 may move such that the visual indicator 470 is aligned with, and therefore visible through, window 460. In one example, the visual indicator is located proximal to the window, which is the direction opposite of the plunger movement during drug delivery. As will be described, there can be many different components that have the visual indicator, and the window formed may be located along different locations of the device.

[0035] In one example, the medication delivery device 420 is an automatic injection apparatus that has a trigger that when actuated by a user results in the needled syringe of the apparatus automatically being driven downward such that the injection needle projects beyond the bottom end of the apparatus housing to penetrate the user. The apparatus then proceeds to automatically inject the medication contents of the syringe through the needle, after which the syringe is retracted automatically such that the injection needle is returned to within the housing. The delay mechanism of the apparatus helps to stage the operation to ensure that the medication contents are properly delivered prior to the needled syringe being retracted. The device 420 can be any pen device or pump.

[0036] With reference to FIGS. 2a and 2b, device 20 includes an outer housing 23 in which are operationally disposed working components of the device. At the top or distal end of the housing and protruding axially therefrom, a safety-controlled button 25 that is part of the user-operated trigger is provided. When the safety sleeve 26 of the housing is disposed in a proper angular orientation relative to the housing body 24 as rotatably adjusted by the user, button 25 is unlocked and can be depressed to start the automatic injection function of the device.

[0037] As further shown in FIGS. 3a and 3b, a tubular main body 24 of housing 23 extends between a proximal end 32 and a distal end 34. The main body 24 may be formedfrom a transparent plastic material, such as ABS plastic. Near the main body distal end, a circumferential or annular snap ring 36 projects inwardly from the housing body interior surface. A longitudinally extending rib 38 for guiding the syringe shuttle projects from the body interior surface proximally of snap ring 36. Near a middle length portion of body 24, a pair of angularly spaced ledges or ribs 40 is formed on the body interior surface for supporting the grease or damping collar 300. An axially extending spline 42 formed on the housing interior surface above one of the ledges 40 serves to rotatably fix collar 300 within the housing. A set of circumferentially spaced retention snaps or ribs 44 angularly offset from ledges 40 and located distally thereof serve to axially locate the follower 250.

[0038] Main body 24 of the outer housing 23 may include a window 31 , as shown in FIG. 2a, that is configured to provide a view to an internal space of the device. Other window configurations may be found in FIGS. 20-27. The window 31 may formed by a different transparency of the material, meaning that the area surrounding the window 31 may be more opaque than the area defining the window 31 . In another embodiment, the window 31 may be defined by a label affixed to main body 24 of the outer housing 22. Window(s) can be formed by the label by various means. For example, the label may either be made of an opaque material or a transparent material that is printed with ink. If the outer main body 24 is made of a transparent material, then the window 31 can be formed as a physical cutout from the label or can be formed while printing on a transparent label the area surrounding the window, leaving the area of the window non-printed. Depending on which of the components have a visual indicator will require the window to be along certain portion(s) of the outer housing 22.

[0039] As will be further described, the container retraction mechanism includes one or more retraction components that have a visual indicator 33 that can be visible through the window 31 when aligned. The alignment may be result of distal movement and / or rotational movement of the retraction component. As will be described, the visual indicator 33 can be placed on at least one of the following, in any combination: the upper shuttle 172 (shown as a solid color in FIG. 9c), the lower shuttle 174 (shown by the dashed box in FIG. 10b), the follower 250 (shown as the dashed box in FIG. l ib), or the drug container. Operation and movement of the retraction component(s) is described below. Also, as described previously in relation to FIG. lb, the retraction component and the drug container may be the same.

[0040] The housing 23 of the shown device 20 also includes a baseplate 50, further shown in FIGS. 4a, 4b and 4c, and an upper body 26 that serves as the safety sleeve, furthershown in FIGS. 5a, 5b, 5c and 5d. Baseplate 50 can be made of the same material as housing main body 24. The baseplate 50 can include a bottom portion 51 that may be keyed to fit within the complementarily shaped-opening at the proximal end 32 of housing body 24. Baseplate 50 can be fixedly secured during manufacture, such as via ultrasonic welding. A central aperture 52 of baseplate portion 51 through which a syringe needle moves out from and then back into the housing during use is ringed by a tube portion 54 that distally extends from portion 51. An interior surface 55 of tube portion 54, which starting at the tube proximal end slopes inward as it extends distally, includes a circumferential shoulder 56 that aids in centering the syringe. A set of three arcuate slots 58 are formed through portion 51 and are flanked by snaps 59 on the distal face of baseplate portion 51.

[0041] A syringe overcap 320, shown in FIGS. 2a and 2b, may be made of plastic, such as polypropylene SR549M, and includes a base 322 that may have a knurled periphery 323. A series or three arcuate cams 325 are in registry with slots 58 and include outwardly facing detents 326 that engage baseplate snaps 59 for a releasable interconnection. A tubular collar 328, upstanding from base 322, is adapted to engage a needle shielding assembly 330. Assembly 330 can maintain the needle sterility and which is removed from the needle when the overcap is removed from housing 22.

[0042] The housing upper body 26 is a sleeve that may be made of a plastic material, such as Lustran ABS 348, which can be opaque. A manually grippable main body portion 62 transitions to a reduced diameter portion 64 that fits within the upper portion of housing main body 24. A circumferential groove 66 in the outer cylindrical periphery of sleeve portion 64 receives housing snap ring 36 during device assembly to allow rotational motion but to prevent axial motion between upper body 26 and main body 24. Opposed notches 68 are formed in the proximal edge of sleeve portion 64. One of the notches 68 accommodates the distal end of housing key 38 to limit the extent of locking sleeve rotation. An opening 70 through sleeve portion 64 forms a lock ledge 71 for shuttle capture. A raised indicator 73 formed on the outer periphery of body portion 62 provides a visual notice function in conjunction with lock and unlock icons shown at 76 in FIG. 2a provided on a label 75 adhered around the housing main body 24. Indicator 73 aligns with icons 76 when the sleeve 26 is rotationally disposed at end angular positions allowed by the abutment with key 38 of the sleeve stops defined by the notch 68.

[0043] The interior surface 78 of housing upper body 26 can include a set of three equally angularly spaced and inwardly projecting snap bumps 80 for engagement with thedevice button 25. A projecting, axially extending rib 82 formed on surface 78 fits within a button slot.

[0044] Button 25 can be made of a sturdy yet suitably resilient material, such as Lustran ABS 348, and is further shown in FIGS. 6a, 6b, 6c, 6d and 6e. Button 25 includes an end disc 88 with a skirt 90 extending proximally from its outer periphery. End disc 88 has a distal face upon which a force can be directly applied by a user to selectively plunge the button to trigger the device. A notch 92 formed in skirt 90 at its proximal end extends axially and forms a slot which receives rib 82 of housing body 26 so as to rotatably key together the button 25 and body 26. A set of three equally angularly spaced resilient fingers 94 each provided with a detent bump 95 on its radially inward face are provided at the base of skirt 90. Each finger 94 is adjacent to one of three equally angularly spaced fingers 97 with inwardly angled stops 98 also provided in skirt 90. Fingers 94 with bumps 95 cooperate with features on the shuttle to help rotationally locate button 25 on the shuttle, and fingers 97 with stops 98 cooperate with features on the shuttle to attach button 25 to the shuttle and help stage device operation.

[0045] Depending from the underside of disc 88 to a height above the proximal tips of fingers 94 and 97 is an activating element 100 of the button that is generally tube shaped. The interior surface of button element 100 at its proximal end is chamfered to form a camming surface 102. A pair of diametrically opposed notches 104 in the proximal end of element 100 serves as clearance slots.

[0046] Skirt 90 is formed with openings therethrough that define a multitude of resilient snaps or latches 106 that are used to secure the button 25 relative to housing upper body 26 after button plunging. Three such angularly spaced latches 106 are shown. Detents 107 formed in the outer periphery of skirt 90 proximally of each latch 106 facilitate manufacturing assembly.

[0047] As shown in FIG. 2b, a medication-filled syringe, generally designated 110, is mounted within device 20. Syringe 110 is shown as including a barrel 112, such as made of glass or other suitable material, with an injection needle 114 mounted at its proximal end which is in fluid communication with the medication contents of the syringe barrel and initially covered by a needle shielding assembly 330. The plunger mechanism of the syringe is formed in two parts by a plunger element, generally designated 116, and an elastomeric sealing member or piston 1 18 that seals the medication within barrel 1 12. The shown barrel112, needle 114, needle shielding assembly 330 and piston 118 are of conventional design, but may be differently configured while still providing suitable functionality. For example, a flexible needle shield without a rigid needle shield may be possible, with suitable adaptations for the device, such as to provide engagement of the flexible shield by the overcap.

[0048] Devices according to the present disclosure may carry and dispense one or more liquid medications, which may also be referred to as medications or drugs and maybe held in the barrel 112. 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, 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 TI, 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 ucenprubart, for treatment of Alzheimer’s and / or dementia, such as with donanemab, remternetug, or GRN gene therapy, for treatment of Parkinson’s disease and / or Gaucher’s disease, such as with GBA1 gene therapy, for treatment of Hidradenitis 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 be operated 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).

[0049] Plunger element 116 can be molded of a lightweight but sturdy and sufficiently resilient material, such as Delrin® 311DP from Dupont Engineering Polymers. As further shown in FIGS. 7a, 7b, 7c and 7d, plunger element 1 16 includes a proximal region120 with a disc-shaped foot 121 at one end that serves to operationally abut sealing piston 118 during plunger advancement, and a disc-shaped flange 123 at the other end. A middle region 124 of the plunger element that extends axially upward from flange 123 includes an axially extending recess or cutaway 125 that further exposes an upper surface 126 of flange 123 which serves as a syringe carrier ledge. A disc-shaped flange 128 with a larger diameter than flange 123 is formed at the upper end of plunger middle region 124. A depending bar or outrigger 130 that during an injection directly engages a locking member to unlock the follower of the device delay mechanism is formed on the outer radial periphery of flange 128. Unlocking bar 130 extends axially and proximally from flange 128 in spaced relationship with plunger middle region 124.

[0050] The distal region of plunger element 116 includes one more prongs 134, shown as a pair of resilient prongs, adapted to latchably engage a shuttle of the device until released by the device triggering mechanism for the shown embodiment. In another embodiment, a single prong plunger mechanism design is shown in US Pat. Pub. No. 2015 / 0246181 to Fourt et al, which is in its entirety incorporated by reference herein.

[0051] In one example, each prong 134 includes an upstanding leg 136 that projects distally from a more central portion of flange 128 with an axially-aligned space or gap 137 between legs 136. At the distal end of its leg 136 each prong 134 includes a latch feature having a latching surface 138, an outward tip 139 at an outer extent of latching surface 138, and a ramp surface 141 . Latching surface 138 extends generally radially outward from leg 136 and faces proximally. Latching surface 138 is formed with a slight undercut so as to slope slightly proximally from leg 136 to tip 139. Ramp surface 141 extends distally and at an angle inward from the tip 139 to form an outward facing ramp used in the inward camming of the prongs for release as described below. Each ramp surface 141, near its radially outer area and along a middle circumferential portion thereof, is interrupted by a locking protuberance 143 integrally formed therewith that projects distally toward button 25. Locking protuberance 143 extends upward the same extent as ramp surface 141 such that the upward tips of the locking protuberances 143 are disposed at the same height as the upward tips of the ramp surfaces 141. The upward tips of locking protuberances 143 are disposed radially outward of the upward tips of the ramp surfaces 141. The radially outwardly facing surfaces 146 of the upward tips of locking protuberances 143 are rounded to facilitate insertion through spring 149 during device assembly.

[0052] Locking protuberance 143 and ramp surface 141 are in spaced relationship in that they define a radial space therebetween. A V-shaped opening 145 that the radial space forms between ramp surface 141 and the inward face of locking protuberance 143 is shaped and sized to receive the proximal end of button element 100.

[0053] An axially extending boss 147 formed on each leg 136 is provided to aid in centering the drive coil spring 149 shown in FIG. 2. The proximal end of spring 149, as centered by dogs 150 on flange 128, seats and acts against flange 128, and the distal end of spring 149 acts against the shuttle.

[0054] An overmolded syringe carrier further shown in FIGS. 8a, 8b, 8c and 8d is generally designated 155 and fits to a keyed flange 111 of syringe barrel 112 to be rotatably fixed together. Syringe carrier 155 includes a base that may be formed of a rigid material, such as DCL4036 20% carbon filled polycarbonate. The base includes a generally C-shaped section 157 from which upwardly projects a support 158 with a radially inwardly protruding clip 159. A protrusion 160 is formed in the top of clip 159 and is used to facilitate the overmolding process. A softer overmolding 162 that fully covers the legs of base section 157 provides a cushioning for the glass syringe held by the carrier to reduce the likelihood of breakage. A suitable overmolding is made of an injection moldable thermoplastic elastomer. When device 20 is fully assembled, syringe barrel 112 snugly fits within central opening 164 with syringe flange 111 captured axially between overmolding 162 and the underside of clip 159, and with the underside of the tip region of clip 159 facing for direct supportive engagement the upper surface 126 of plunger flange 123. This supportive engagement of the syringe carrier clip 159 by surface 126 prevents the syringe 110 held within carrier 155 from moving outward of the housing 23 before device use. In another embodiment, a two-piece syringe carrier is described in US Pat. Pub. No. 2021 / 0275745 to Atterbury et al, which is in its entirety incorporated by reference herein.

[0055] The delay mechanism and the container retraction mechanism of device 20 can include at least one of a shuttle, generally designated 170, a follower 250 that releasably latches with the shuttle 170, and a dual functioning biasing member 290 acting between the shuttle and the follower. In the shown embodiment, shuttle 170 is formed of an upper shuttle 172 and a lower shuttle 174 further shown in FIGS. 9a, 9b, 9c, 9d and 9e and FIGS. 10a, 10b, 10c, lOd and lOe, respectively. Shuttle parts 172 and 174 are fixedly connected during manufacturing assembly, such as with the described snap fit or other suitable connection manner, to together serve as the shuttle. The multi-piece construction facilitates molding andassembly of the shuttle, as well as the assembly of the device components within the interior hollow 175 of the shuttle. One suitable material for shuttle part 172 may be a plastic such as EXL1992T Polycarbonate alloy that can be transparent, and one suitable material for shuttle part 174 is a polycarbonate such as Makrolon 2458 that can be transparent.

[0056] The bottom portion 176 of upper shuttle 172 includes a protruding alignment block or key 178 that closely fits within a notch 222 formed in the distal end 223 of the body 220 of lower shuttle 174. During manufacturing assembly of the mating shuttle parts, radially protruding and partially circumferentially extending lips 180 provided on opposite sides of upper shuttle 172 snap lock over ledges 225 defined by windows 226 formed in lower shuttle 174. A pair of keys 182 projecting from the periphery of upper shuttle 172, one of each key 182 above each lip 180, fits into smaller notches 228 formed in the distal end 223 of shuttle body 220. The fitting of keys 182 within notches 228 and alignment block 178 within notch 222 rotatably fixes the shuttle parts together when connected.

[0057] The bottom portion 176 of upper shuttle 172 above block 178 includes an opening 184 from which a locking flexure 186 outwardly extends at an angle. Flexure 186 cooperates with the lock ledge 71 of the housing to secure the shuttle in a retracted position after use. On the side of shuttle 172 opposite of opening 184, an opening or slot 188 extending to the bottom of the upper shuttle is provided which accommodates plunger outrigger 130. Ribs 189 formed in the inner surface of bottom portion 176 serve as stops for abutment by syringe flange 1 1 1 to limit distal movement of the syringe 1 10 during assembly.

[0058] The upper portion of upper shuttle 172 is a tubular, cylindrical body 190 with an overhanging cap portion 192. A central aperture 194 through cap portion 192 allows passage of the latching portion of plunger prongs 134. A pair of dogs 196 that project distally from the top surface of cap portion 192 are diametrically opposed around aperture 194 and help guide activating element 100 of button 25 into aperture 194 during use. The prongengaging surfaces 195 between dogs 196 include a ramping upward surface adjacent to aperture 194 that is complementary to the undercut of latching surfaces 138 to provide a more secure but releasable connection therebetween. A collar 198 depending from the underside 199 of cap portion 192 within hollow 175 centers the distal end of spring 149 that acts directly against underside 199. Two opposing cut outs 200 in collar 198 allow passage of locking protrusions 143 of prongs 134 and aid assembly by presenting a ramp surface that deflects the prongs inward during assembly.

[0059] The outer radial periphery of cap portion 192 includes three beveled sections 202 and three land sections 203 in alternating arrangement around the shuttle circumference. The angular ends of each land section 203 are defined by grooves or indents 205. Land sections 203 are designed to have detents 95 of button fingers 94 slide therealong during button rotation. Indents 205 cooperate with detents 95 to aid in keeping the button in one of two preferred angular or rotational positions relative to the shuttle 170, but which detent connections can be readily overcome when the button is moved between such positions by manual rotation of the sleeve 26. The interaction between indents 205 and detents 95 also provides a tactile and audible indication of when the button rotation has reached an end point.

[0060] Three stop ribs, generally designated 204, project from the periphery of shuttle body 190 proximally of the three cap beveled sections 202. Each stop rib includes a circumferentially extending segment 206, an upstanding axially extending segment 208 at one end of segment 206, and a depending axially extending segment 210 with an angled lead- in 21 1 at the other end of segment 206. Three axially extending stop ribs 214 are provided proximally of the three land sections 203.

[0061] During manufacturing assembly, button 25 is mounted to shuttle 170 by moving the parts axially together such that button fingers 97 with stops 98 slide and snap fit over cap beveled sections 202, at which point distal removal of the button is resisted by stops 98 abutting the overhanging lip of the beveled sections 202 of cap portion 192. When button 25 is so mounted, rib segments 206 serve as axial stops for button stops 98 to abut and thereby frustrate manual button plunging when the button is not in an unlocked state. Rib segments 208 work with stops 98 to further prevent button 25 from being rotated in the wrong direction from a locked state, and stop ribs 214 prevent button 25 from being rotated too far during unlocking. Rib segments 210 and stop ribs 214 guide the downward travel of the button during its plunging, and the longer rib segment 210 shown in FIG. 9c serves as an abutment for a stop 98 to prevent manual relocking of the sleeve 26 during fluid delivery.

[0062] Lower shuttle 174 is generally tubular with a cylindrical body 220 that steps down via a substantially annular, radially aligned flange 221 to a reduced diameter, cylindrical proximal region 230 that fits within follower 250. Flange 221 is interrupted by an upstanding rib region 247. Flange 221 serves as the support that directly engages the syringe carrier 155 for effectively engaging and carrying the syringe upward to withdraw the syringe needle after injection. A bar 238 that extends distally from distal end 223 is used to rotatably lock housing sleeve 26 after an injection by fitting within a notch 68. At its proximal end,shuttle 174 includes an annular lip 233 that extends radially inward to define the opening through which extends syringe barrel 112. An annular recess provided around the end of proximal region 230 outward of lip 233 forms a shoulder 231 that seats and centers the biasing member 290 described below that acts on the shuttle. An axially extending groove 232 in lower shuttle body 220 receives housing key 38 to rotatably fix shuttle 170 with housing 23 along the entire axial travel of the shuttle therein.

[0063] The shuttle includes at least one latching element for releasably engaging the follower 250 of the container retraction mechanism. The latching element is shown provided as a set of tabs 234 and 236 that are angularly spaced around and radially outwardly project from proximal region 230 near its proximal end. Tabs 234 and 236 are shown as differently sized, block-shaped projections that serve as latching hooks to engage the follower.

[0064] An axially oriented notch 240 that opens radially outward is formed through tab 234 and into shoulder 231. Notch 240 is sized and configured to receive an upper projection 294 of the biasing member. As shown in FIG. lOe, notch 240 can include a circumferential jog at its inward depth that results in tab 234 providing a pocket 235 for radially retaining the biasing member upper projection.

[0065] At the proximal end of lower shuttle body 220 on its outer periphery, an angled, locking latch surface 242 is formed therein. Latch surface 242 is disposed proximally of and angularly adjacent to an opening 244 formed in the upward protruding rib region 247. Opening 244 is disposed in line with an axially extending channel 246 formed in the interior surface of lower shuttle body 220 along its entire height. The edges of rib region 247 defining opening 244 are sloped to help lead outrigger 130 into the opening. Channel 246 accommodates plunger outrigger 130 to loosely rotatably key shuttle 170 and plunger element 116 while allowing axial motion of the plunger element 116 relative to the shuttle such that the proximal tip of outrigger 130 can project through opening 244 to unlock the locking mechanism described below.

[0066] The follower 250 is further shown in FIGS. I la, 11b, 11c, 1 Id and l ie.Follower 250 can be formed of a rigid yet sufficiently resilient material to integrally provide the locking member feature. One suitable material for the shown follower 250 is Delrin® 311DP. Follower 250 includes an upper portion 252 that fits concentrically around shuttle proximal region 230. Two partially circumferentially extending ledges 254 and 256 are formed in follower portion 252 and serve as latching elements that engage shuttle latchingtabs 234 and 236. Ledge 254 is formed by a window 258 through follower portion 252 and opens at one angular end to an axially extending channel 260 formed in the interior surface of follower portion 252. Ledge 256 in part opens to window 261 and at one angular end opens to an opening 262 in follower portion 252. Channel 260 and opening 262 allow axial movement of tabs 234 and 236 therein for manufacturing assembly and for shuttle release relative to the follower during device use. Opening 262 tapers at 264 to a slot-shaped portion 266 adapted to closely receive a radial projection 296 of the biasing member.

[0067] Near the base of follower portion 252, a flange 268 that extends around the majority of the circumference projects radially outward from follow portion 252. Flange 268 snaps past housing snaps 44 during device assembly. The interior surface of follower portion 252 includes an inwardly projecting ring 270 provided with three equally angularly spaced ribs 272 on its upper face. Ring 270 defines an opening through which the syringe barrel extends and provides a seat for the biasing member that is centered by ribs 272.

[0068] A sleeve shaped lower portion 274 of follower 250 depends from follower portion 252 and has a lesser diameter. Four slots 276 in the proximal edge of portion 274 define four damping fins 278 of the follower.

[0069] A locking member for follower 250 to limit its rotation relative to the shuttle 170 is integrally formed with follower 250. In alternate embodiments, differently configured locking members, including being a separate piece or being formed with the shuttle, may be employed. The locking member is generally designated 280 and is formed as a flexure arm 282 with an upwardly extending latch 284 at its end. Flexure arm 282 extends in a generally circumferential direction from follower upper portion 252. As flexure arm 282 occupies a similar annular space as follower portion 252, and because arm 282 is designed to be bent axially to cause latch 284 to be moved axially relative to the shuttle in order to unlock the follower for rotation, an axial space 286 between arm 282 and the area of the follower portion above window 261 is provided to accommodate arm bending. Such space would not be required if, for example, the latch was unlocked via a radial movement thereof.

[0070] The dual functionality of biasing member 290 results from it providing a torsional force and an axial force during use, both of which forces act directly between follower 250 and shuttle 170. For the configuration shown in device 20, biasing member 290 functions as both a torsion spring and a compression spring, and can be made as a single component that is readily handled during manufacturing assembly. The torsional force andaxial force result from a release of a torsional preloading and an axial preloading of the biasing member 290, which preloading has been accomplished during the manufacturing assembly of device 20. In some devices, the biasing member 290 may be configured to provide only an axial load for retraction.

[0071] Biasing member 290 is shown as a cylindrical spring formed of a helically coiled wire 292. One suitable such spring is made of 302 stainless steel with a wire diameter of 0.024 inch. Spring 290 is selected to provide suitable torsional and axial forces within the available space, and the selection is dependent upon the device operation, such as the delay required, and the design of the cooperating components, such as the damping compound and follower and grease cup configurations. Other designs of biasing members, such as a metal or plastic flexure configured to perform the dual functions, may be substituted for the single metal coil spring shown. In some devices, the biasing member 290 may be configured to provide only an axial load for retraction.

[0072] The internal opening 295 of spring 290 freely receives lower shuttle proximal region 230, while the outer diameter of spring 290 freely fits within follower upper portion 252. The distal end coil 293 of wire 292 which abuts the shuttle shoulder 231 terminates with a protruding end or tip 294 that projects distally. Tip 294 is disposed within the cross- sectional area of the cylindrical coil as shown in FIG. 12c. Tip 294 is sized and shaped to fit within shuttle pocket 235 to engage shuttle 170. The proximal end coil 297 of wire 292 which abuts the follower ring 270 terminates with a radially outwardly protruding tip 296. Tip 296 extends beyond the cross-sectional area of the cylindrical coil. Tip 296 is sized and shaped to closely fit within opening portion 266 to engage follower 250.

[0073] During manufacturing assembly of device 20, with spring 290 arranged so that tips 294 and 296 respectively fit within pocket 235 and opening 266 of the spaced follower 250 and lower shuttle 174, spring 290 is preloaded both axially and torsionally between follower 250 and shuttle lower portion 174 as the follower and shuttle lower portion are brought together axially and rotated so as to be latched, via the interaction of ledges 254, 256 and tabs 234, 236, and then so locked, via the interaction of locking member 280 and shuttle surface 242.

[0074] A grease cup or collar, generally designated 300, is further shown in FIGS. 13a, 13b, 13c and 13d. Cup 300 provides a support surface for the damping fluid as the follower 250 rotates relative to that support surface. In an alternate embodiment, the supportsurface can be otherwise provided, such as being integrally formed with the housing body. Cup 300 can be made from a plastic material, such as ABS TR-558A1 from LG Chemical Ltd, that that can be transparent. Cup 300 includes an annular body 302 that has a generally cylindrical outer periphery, and a round central aperture 303 through which fits the syringe barrel. Cup 300 is axially supported within housing 23 by ledges 40. Ribs 304 define a keying slot 305 on the outer periphery. Two slots 305 are shown, but only one is needed to fit over the housing spline 42 that rotatably fixes cup 300 and housing 22, and the other slot makes initial orientation less critical during assembly as well as typically allows passage over key 38 during assembly. Cup body 302 includes a generally U-shaped wall portion 308 that defines an annular hollow or channel 307. Enlarged areas 309 that open into the top of hollow 307 are so sized to better accommodate the nozzles by which the damping compound is inserted into the hollow 307.

[0075] A damping compound or fluid 315, such as a silicone -based grease that can be thickened with Teflon or another compound, can be used to fill annular hollow 307. Follower fins 278 fit within hollow 307 such that compound 315 is disposed both radially inward and outward of such fins 278, as well as between adjacent fins 278 and as a film between the fin undersides and the base of the follower wall, resulting in a damping or timing delay effect as the follower fins 278 try to rotate relative to the U-shaped interior surface of wall portion 308 with the viscous damping fluid providing a resistance to this rotation during operation. Other compounds with different properties may be selected by one of skill in the art in view of the delay selected by the manufacturer to be provided by the delay mechanism, and in view of modifications that may be made by the skilled artisan to the placement of the compound as well as other aspects of the delay mechanism, such as the spring-generated torsional force and the size and shape of the follower and the grease collar. The damping compound selected may provide the desired timing delay for such a device and medication.

[0076] The construction of device 20 will be further understood in view of a description of its operation. With the device initially configured in a locked state as shown in FIGS. 2a and 2b, the device cannot be triggered. If a user applies a plunging force on button 25, the button stops 98 axially abut shuttle rib segments 206. Furthermore, due to button activating element 100 extending within V-shaped opening 145 but with clearance slots 104 being rotationally out of alignment from locking protuberances 143, the protuberances 143 will abut the outer periphery of element 100 and prevent inward movement of prongs 134 sufficient for disengagement from the shuttle.

[0077] The syringe overcap 320 is then manually removed by the user overcoming the engagement of overcap detents 326 with snaps 59 and pulling the overcap proximally off of the housing to also remove the needle shielding assembly 330. This overcap removal is facilitated by the user twisting the overcap relative to the housing, which twisting, due to the camming effect of cams 325 against plate 51, shifts the overcap proximally. The engagement of the syringe carrier clip 159 with plunger flange surface 126 limits proximal motion of syringe 110. After overcap removal, device 20 is arranged as shown in FIG. 14.

[0078] To allow for an injection, the locking or safety that prevents triggering needs to be unlocked. This unlocking can be done before or after the device 20 is oriented at the injection site. The user can grip and manually rotate locking sleeve 26 relative to the housing main body 24 until the alignment indicator 73 is in registry with the unlock icon of icons 76, at which the edge of sleeve notch 68 abuts housing key 38. This rotation of sleeve 26 rotates button 25 due to the keyed connection therebetween. Besides the visible icon, the unlocked registration or state also will be indicated by the button finger detents 95 snapping into the indents 205 at the opposite ends of the land sections 203 at which the button detents were initially located in FIG. 14. At this point, button stops 98 have been moved angularly clear of shuttle rib segments 206, and clearance slots 104 are now rotationally aligned with protuberances 143, and device 20 is arranged as shown in FIG. 15 and prepared for an injection.

[0079] In this prepared state, and with the device positioned at an injection site, when a user applies a plunging or downforce on button 25, button 25 starts to move into housing sleeve 26 as activating element 100 engages prong ramp surfaces 141. As button 25 moves further, prong legs 136 bend inward, reducing gap 137, due to the camming inward of the ramp surfaces by the button element 100. Locking protuberances 143 fit through clearance slots 104 so as to not prevent this prong inward motion. When prongs 134 have been bent inward sufficiently to disengage latching surfaces 138 from shuttle surfaces 195, at which point the plunger prongs can fit through the shuttle opening 194 as shown in FIG. 16, the drive spring 149 directly biases the plunger element 116 downward to drive it and thereby piston 118 proximally, which driven motion shifts syringe barrel 112 proximally relative to the shuttle and the housing 23 to cause the tip of needle 114 to project beyond housing proximal end for penetrating a user's skin, and then forces the medication contents of the syringe through that needle for an injection. In FIG. 16, the button 25 is shown at the end of its plunging, at which arrangement sleeve rib 82 reaches the end of button slot 92, and buttonlatches 106 have snap fit under sleeve snap bumps 80 to hold the button in its plunged condition relative to the housing, and with button end disc 88 flush with the top edge of sleeve 26 so as to visually indicate device use. In FIG. 16, the plunger element is shown unlatched from the shuttle but before the spring 149 has largely uncoiled to drive the plunger element downward.

[0080] As plunger element 116 moves proximally during medication injection, the outrigger 130 of the plunger element, as shown in FIG. 17, slides within shuttle slot 188 and then channel 246 until the proximal tip of outrigger 130 enters opening 244 and abuts and unlocks locking member 280. In particular, the outrigger 1 0 abuts an upper face of latch 284 and shifts latch 284 axially, by bending flexure 282 to close the gap 286, which axially shifting unlatches latch 284 from shuttle latching surface 242 so as to unlock the follower 250 for rotation. This unlocking typically will be designed to occur shortly before the end of proximal travel of the plunger mechanism, i.e., at or shortly before the point in time when device 20 finishes delivering medication from syringe barrel 112 through needle 1 14.

[0081] When locking member 280 is so unlocked or released, the follower 250, as urged by the torsional preloading of biasing member 290, rotates within the housing 24 and around the rotatably fixed shuttle 170. The viscous damping compound 315 between the follower fins 278 and cup wall portion 308 dampens or offers a resisting force to this follower rotation, which resistance results in a passage of time before shuttle unlatching, during which time remaining medication can be properly expelled from the syringe through the needle. Rotation of follower 250 about shuttle 170 is driven by spring 290 until follower opening 262 and channel 260 align with shuttle tabs 236 and 234, respectively. In this arrangement, at which device 20 is shown in FIG. 18, tabs 234 and 236 are clear of ledges 254 and 256 such that shuttle 170 and follower 250 are unlatched.

[0082] When shuttle 170 and follower 250 are so unlatched, the shuttle 170, as urged by the compressive preloading of biasing member 290, translates distally within the housing 24 until distal end 223 of lower shuttle 174 meets the proximal end 69 of body 26. As shuttle 170 is retracted, the needled syringe 110 is carried by the shuttle distally so as to retract the proximal tip of the injection needle 114 to a protected position within the housing 24. In other words, follower 250 starts rotating at or shortly before the point in time when device 20 finishes delivering medication, and stops rotating when device 20’ s retraction mechanism starts its retraction movement. The shuttle is held in this retracted position by the axial force of the biasing member 290 and is locked in this retracted position by the snap fitting ofshuttle locking flexure 186 within opening 70 against ledge 71. Attempts by the user to rotate sleeve 26 relative to housing 24 is frustrated by the presence of bar 238 within a notch 68. At this point, the device is configured as in FIG. 19, and the user then can dispose or otherwise handle the device in the normal course.

[0083] Device 20 is designed to facilitate its manufacturing assembly. For example, a subassembly of lower shuttle 174, spring 290, follower 250, and damping collar 300 with damping compound 315 can be snap fit into a housing subassembly of main body 24 and baseplate 50. Another assembly process can involve placing a syringe 100 in alignment with a subassembly of upper shuttle 172, drive spring 149, plunger element 116, button 25 and sleeve 26, snap assembling syringe carrier 155 to the syringe and plunger element, assembling this entire subassembly to the previously assembled lower shuttle assembly and housing, applying a label to the housing, and then securing the overcap 320 to the housing baseplate 50 in engagement with a previously assembled needle shielding assembly 330.

[0084] The following figures describe various embodiments of the visual indicator(s) on the retraction component(s). Although a specific component is identified as the retraction component for that particular embodiment in the corresponding figures, it is recognized that the same concept may be applied to another retraction component described herein.

[0085] FIGS. 20-21 depict operation of the medication delivery device 20 with one embodiment of the visual injection status indicator. The medication delivery device 20 has the visual indicator 33 (shown in dashed lined) disposed along the lower shuttle 174 (shown in dashed lines) internal to the device, which in this example is the retraction component of the container retraction mechanism that is configured to move at a start of retraction and stop at the end of retraction. As described herein, the visual indicator 33 can be provided on other internal components used in the retraction. In FIG. 20, the lower shuttle 174 is positioned such the visual indicator 33 is proximal to the window 31 (such that visual indicator 33 is not visible through window 31 ) at a first state, typically prior to or during the injection operation of the device as described in relation to FIGS. 14-17. The device 20 in FIG. 20 shows the window 31 formed by the label 75. In FIG. 21, the lower shuttle 174 is now positioned such the visual indicator 33, after movement in the distal direction shown by the arrow, is in axial alignment with the window 31 (such that visual indicator 33 is now visible through window 33) at a second state, typically after the injection operation and at the end of the retraction of the drug container of the device as described in relation to FIG. 19.

[0086] FIGS. 22-23 depict operation of the medication delivery device 20 with another embodiment of the visual injection status indicator. The medication delivery device 20 has a first visual indicator 33a and a second visual indicator 33b (shown in dashed lined) disposed along the upper shuttle 172 (shown in dashed lines) internal to the device, which in this example is the retraction component of the container retraction mechanism that is configured to move at a start of retraction and stop at the end of retraction. In one embodiment, the first indicator and the second indicator may be arranged axially fixed relative to one another. As described herein, the visual indicator(s) can be provided on other internal components used in the retraction. In FIG. 22, the upper shuttle 172 is positioned such the second visual indicator 33a is axially aligned with the window 31, and the first visual indicator 33b is proximal to the window 31 at a first state (i.e., such that the second visual indicator 33a is visible through window 1, but the first visual indicator 33b is not visible through the window 31), typically prior to or during the injection operation of the device as described in relation to FIGS. 14-17. The second visual indicator 33a has a different visual characteristic than the first visual indicator 33b, such as, for example, having different colors. In FIG. 23, the upper shuttle 172 is now positioned such the first visual indicator 33b, after movement in the distal direction shown by the arrow, is in axial alignment with the window 31 at a second state (i.e., such that the first visual indicator 33b is now visible through the window 31, but the second visual indicator 33a is not), typically after the injection operation and at the end of the retraction of the drug container of the device as described in relation to FIG. 19. In one embodiment, a second window (not shown) is provided along the device and the second visual indicator 33a is also visible through the second window after retraction. In another embodiment, the first indicator 33b may be disposed on a first retraction component, such as, for example, one of the upper shuttle 172, the lower shuttle 174 or at least one portion of the syringe 110, and the second indicator 33a may be disposed on a second retraction component, another one of the upper shuttle, the lower shuttle, or at least one portion of the syringe 110. In this embodiment, either a single window is arranged along the housing to allow for visibility of the indicators disposed on the first and second retraction components, or alternatively, a first window and a second window are arranged along the housing to allow for visibility of the indicators disposed on the first and second retraction components.

[0087] FIGS. 24-25 depict operation of the medication delivery device 20 with another embodiment of the visual injection status indicator. The medication delivery device20 has a visual indicator 33’ (shown in dashed lined) disposed along the follower 250 (shown in dashed lines) internal to the device, which in this example is the retraction component of the container retraction mechanism that is configured to stop moving at a start of retraction. As described herein, the visual indicator 33’ can be provided on other components used in the retraction. In FIG. 24, the follower 250 is positioned such the visual indicator 33’ is circumferentially offset from the window 31’ at a first state (such that visual indicator 33’ is not visible through the window 31’), typically prior to the injection operation of the device as described in relation to FIGS. 14-17. In FIG. 25, the follower 250 is now positioned such the visual indicator 33’, after being stopped from movement in a rotational direction shown by the arrow, to be in circumferential alignment with the window 31’ at a second state (such that visual indicator 33’ is now visible through the window 31’), typically after the injection operation and at the start of the retraction of the drug container of the device as described in relation to FIG. 18. Because of the angular rotation of the follower 250 relative to the cup 300, which starts at or shortly before the end of plunger movement and ends after the time delay, which is when retraction of the syringe begins, the visual indicator 33’ becomes visible through window 31 ’ when retraction of the syringe begins.

[0088] FIGS. 26-27 depict operation of the medication delivery device 20 with another embodiment of the visual injection status indicator, namely two states of injection status - (1) injection completed and needle still extended beyond the device end and (2) injection completed and syringe retracted. The medication delivery device 20 has a first visual indicator 33a’ (shown in dashed lined) disposed along the follower 250 (shown in dashed lines) internal to the device, and a second visual indicator 33b’ (shown in dashed lines) disposed along either of the shuttles 172 or 174 (the lower shuttle 174 shown) internal to the device, which in this example are the retraction components of the container retraction mechanism. As described herein, the visual indicators 33a’ or 33b’ can be provided on other components used in the retraction. In FIG. 26, the follower 250 is positioned such the first visual indicator 33a’ is circumferentially offset from the first window 31a’ at a first state (such that the first visual indicator 33a’ is not visible through window 31a’), typically prior to the injection operation of the device as described in relation to FIGS. 14-17. Further, the lower shuttle 174 is positioned such the second visual indicator 33b’ is proximal to the second window 31b’ at the first state (such that the second visual indicator 33b’ is not visible through the second window 31b’). In FIG. 27, the follower 250 is now positioned such the first visual indicator 33a’, after movement in a rotational direction shown by the arrow, is incircumferential alignment with the first window 31a’ at a second state, typically after the injection operation and at the start of the retraction of the drug container of the device as described in relation to FIG. 18. Because of the angular rotation of the follower 250 relative to the cup 300, which starts at or shortly before the end of plunger movement and ends after the time delay, which is when retraction of the syringe begins, the first visual indicator 33a’ becomes visible through the window 31a’ when medication delivery is complete and retraction of the syringe begins, e.g., the lower shuttle 174 begins moving in the distal direction shown by the arrow. Shortly after the first visual indicator 33a’ becomes visible through window 31a’, the device 20 completes retraction of the syringe. Upon completion of retraction, the lower shuttle 174 is now positioned such the second visual indicator 33a’is in axial alignment with the second window 31b’ (such that the second visual indicator 33a’ is now visible through the second window 31b’) at a third state, typically after the injection operation and the retraction of the drug container of the device as described in relation to FIG. 19. To this end, visibility of the first indicator 33a’ is configured to occur prior to visibility of the second indicator 33b’.

[0089] FIG. 29 is a flow diagram of the method (500) of use of the device, including any one or more following steps. In one step (502), providing an embodiment of the medication delivery device described herein. The retraction component of the device includes a visual indicator that is not visible through the window when the medication delivery device is in a first state of device operation, and is visible through the window when the medication delivery device is in a second state of device operation. In one step (504), the user places the outlet of the medication delivery device at a treatment site. The medication delivery device is in the first state of device operation. In one step (506), the user actuates the device to injection the medication to the treatment site. The medication delivery device is configured to switch from the first state of device operation to the second state of device operation. In one step (508), the user observes window to determine when visual indicator becomes visibility in window for an operational status of said device. In one step (510), the user removes the device from the treatment site when the visual indicator is visible in the window.

[0090] Various aspects are described in this disclosure, which include, but are not limited to, the following aspects:

[0091] In various aspects of the disclosure, a medication delivery device includes a housing having a length extending in an axial direction between a proximal end and a distal end, the housing defining a window, a container of medication including an outlet that isplaceable proximally of the housing proximal end at least during an injection event, the container including a container housing and a sealing plunger, the sealing plunger in sealing engagement with the container housing; a drive mechanism within the housing that is configured to advance the sealing plunger proximally within the container to force medication from the outlet during injection, a container retraction mechanism coupled to the container, wherein when triggered the container retraction mechanism is configured to retract the outlet distally within the housing after the medication is forced from the outlet, the container retraction mechanism comprising a retraction component configured to stop moving or start moving at a start of retraction, wherein the retraction component comprises a visual indicator that, upon completion of medication delivery or the injection event, is configured to be visible through the window to indicate an operational status of said device.

[0092] In various aspects of the disclosure, the visual indicator is proximal to the window such that the visual indicator is not visible through the window prior to the completion of the injection event, and is moved distally at the completion of the injection event such that the visual indicator is visible through the window.

[0093] In various aspects of the disclosure, the visual indicator is a first visual indicator, and the retraction component comprises a second visual indicator that, when the medication delivery device is in an operational state prior to the completion of the injection event, is visible through the window.

[0094] In various aspects of the disclosure, the first visual indicator is axially fixed relative to the second visual indicator.

[0095] In various aspects of the disclosure, the first visual indicator and the second visual indicator are disposed on the retraction component.

[0096] In various aspects of the disclosure, the retraction component is a first retraction component, and the device further includes a second retraction component, wherein the first visual indicator is associated with the first retraction component, and the second visual indicator is associated with the second retraction component.

[0097] In various aspects of the disclosure, the visual indicator is a first visual indicator and the window is a first window, and the device further includes a second retraction component including a second visual indicator that is visible through the second window as indication of a start of the retraction of the container of the device.

[0098] In various aspects of the disclosure, the visibility of the second indicator is configured to occur prior the visibility of the first indicator.

[0099] In various aspects of the disclosure, the first retraction component is movable axially, and the second retraction component is rotatable.

[0100] In various aspects of the disclosure, the visual indicator is angularly offset from the window at a first state, and is rotatably moved at the completion of the injection to align the visual indicator with the window.

[0101] In various aspects of the disclosure, the window is formed by material in the housing.

[0102] In various aspects of the disclosure, a label is affixed to the housing, wherein the window is formed by material of the label.

[0103] In various aspects of the disclosure, the visual indicator includes at least one of a color, a graphic image, a text, or a symbol.

[0104] In various aspects of the disclosure, the window extends circumferentially by at least 270 degrees.

[0105] In various aspects of the disclosure, a medication delivery device including a housing having a length extending in an axial direction between a proximal end and a distal end; a syringe of medication including a needle that is placeable proximally of the housing proximal end at least during an injection event, the syringe including a syringe barrel and a sealing plunger, the sealing plunger in sealing engagement with the syringe barrel; a drive mechanism within the housing that is configured to advance the sealing plunger proximally within the syringe barrel to force medication from the syringe needle during the injection event; a syringe retraction mechanism coupled to the syringe, wherein when triggered the syringe is retracted distally within the housing after the medication is forced from the syringe needle, the syringe retraction mechanism including a retraction component configured to move distally and stop; and a window formed along the housing, wherein the retraction component includes a visual indicator that is not visible through the window prior to the injection event and is visible through the window as indication of a completion of the injection event.

[0106] In various aspects of the disclosure, the visual indicator is a first visual indicator, the device further including a second visual indicator that is visible through thewindow prior to the injection event and is not visible through the window as indication of the completion of the injection event.

[0107] In various aspects of the disclosure, the retraction component is a first retraction component, and the device further includes a second window and a second retraction component having a second visual indicator, wherein the visual indicator is associated with the first retraction component, wherein the second visual indicator that is not visible through the second window prior to the injection event and is visible through the second window as indication of the completion of the injection event prior to visibility of the visual indicator in the window.

[0108] In various aspects of the disclosure, a method of treatment of a disease with a medication delivery device, including: providing a medication delivery device, wherein the medication delivery device includes a housing having a length extending in an axial direction between a proximal end and a distal end, a container of medication including an outlet that is placeable proximally of the housing proximal end at least during an injection event, the container including a container housing and a sealing plunger, the sealing plunger in sealing engagement with the container housing, a drive mechanism within the housing that is configured to advance the sealing plunger proximally within the container to force medication from the container outlet during the injection event, a container retraction mechanism coupled to the container, wherein when triggered the container is retracted distally within the housing after the medication is forced from the container outlet, the container retraction mechanism including a retraction component configured to stop or move at a start of retraction, and a window formed along the housing, wherein the container or the retraction component includes a visual indicator that is not visible through the window in a first state of device operation, and is visible through the window in a second state of device operation; placing the outlet of the medication delivery device a treatment site, wherein the visual indicator is not visible; actuating the medication delivery device to inject the medication from the medication delivery device to treatment site; when the visual indicator is visible through the window, removing the medication delivery device from the treatment site, wherein the visual indicator has moved distally away from the outlet to align with the window.

[0109] In various aspects of the disclosure, the visual indicator is a first visual indicator, the medication delivery device further including a second visual indicator that is visible through the window prior to the injection event and is not visible through the windowas indication of a completion of the injection event, wherein the placing step further includes placing the outlet of the medication delivery device a treatment site, wherein the visual indicator is not visible and the second visual indicator is visible, and after the actuating step and prior to the removing step, the visual indicator is visible and the second visual indicator is not visible.

[0110] In various aspects of the disclosure, the visual indicator is a first visual indicator, the medication delivery device further including a second window and a second visual indicator that is not visible through the second window prior to the start of retraction and is visible at the start of retraction, wherein the placing step further includes placing the outlet of the medication delivery device a treatment site, wherein each of the visual indicator and the second visual indicator is not visible, and after the actuating step and prior to the removing step, the second visual indicator is visible prior to when the visual indicator is visible.

[0111] Solely for ease of explication, FIGS, la, lb, and 2a and 2b, and all subsequent figures will use the x, y, z directional system. In the specification and claims, references to the “up,” “upward,” or “upper” direction shall mean the positive z direction; references to the “down,” “downward,” or “lower” direction shall mean the negative z direction; references to the “proximal” direction shall mean the negative x direction; references to the “distal” direction shall mean the positive x direction; references to the “left” direction shall mean the positive y direction; and references to the “right” direction shall mean the negative y direction. As used herein, distal and proximal refer to axial locations relative to the treatment site when the device is oriented for use at such site, whereby, for example, proximal end of the housing refers to the housing end that is farther way from the user and closest to such injection site.

[0112] The terms "first", "second", "third" and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and / or arrangements than are described or illustrated herein.

[0113] While the embodiments disclosed herein have been shown and described as having preferred designs, the present disclosure may he modified within the spirit and scopeof this disclosure. For example, differently configured releasable locking members may be used to keep the syringe and follower rotationally fixed despite the torsional force applied by the biasing member. Furthermore, the shuttle and the associated delay mechanism and the container retraction mechanism can be used in devices with different other components, such as alternate trigger locking devices, just as the shown trigger locking device can be used with differently configured automatic syringe moving mechanisms. Still further, the dual functioning biasing member may be configured to work with differently configured components of a delay mechanism and the container retraction mechanism, such as the shuttle and follower still having a fluid dampened relative rotation upon unlocking, but where the follower and shuttle do not unlatch after follower rotation but rather move together axially when the follower instead unlatches from the housing, and the dual functioning biasing member acts not directly between the follower and shuttle in such container retraction mechanism but rather acts between the follower and housing. This application is therefore intended to cover any variations, uses or adaptations of the invention 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 invention pertains.

Claims

WHAT IS CLAIMED IS:

1. A medication delivery device comprising: a housing having a length extending in an axial direction between a proximal end and a distal end, the housing defining a window; a container of medication including an outlet that is placeable proximally of said housing proximal end at least during an injection event, said container including a container housing and a sealing plunger, said sealing plunger in sealing engagement with said container housing; a drive mechanism within said housing that is configured to advance said sealing plunger proximally within said container to force medication from the container outlet during the injection event; and a container retraction mechanism coupled to the container, wherein when triggered the container retraction mechanism is configured to retract the outlet distally within the housing after the medication is forced from the outlet, the container retraction mechanism comprising a retraction component configured to stop moving or start moving at a start of retraction; wherein the retraction component comprises a visual indicator that, upon completion of medication delivery or the injection event, is configured to be visible through the window to indicate an operational status of said device.

2. The medication delivery device of claim 1 , wherein the visual indicator is proximal to the window such that the visual indicator is not visible through the window prior to the completion of the injection event, and is moved distally at the completion of the injection event such that the visual indicator is visible through the window.

3. The medication delivery device of any one of claims 1-2, wherein the visual indicator is a first visual indicator, and the retraction component comprises a second visual indicator that, when the medication delivery device is in an operational state prior to the completion of the injection event, is visible through the window.

4. The medication delivery device of claim 3, wherein the first visual indicator is axially fixed relative to the second visual indicator.

5. The medication delivery device of claim 4, wherein the first visual indicator and the second visual indicator are disposed on the retraction component.

6. The medication delivery device of claim 3, wherein the retraction component is a first retraction component, and the device further comprises a second retraction component, wherein the first visual indicator is disposed on the first retraction component, and the second visual indicator is disposed on the second retraction component.

7. The medication delivery device of claim 1, wherein the visual indicator is a first visual indicator and the window is a first window, and the device further defines a second window and comprises a second retraction component comprising a second visual indicator that is visible through said second window upon completion of medication delivery.

8. The medication delivery device of claim 7, wherein the visibility of the second indicator is configured to occur prior to the visibility of the first indicator.

9. The medication delivery device of claim 7, wherein the first retraction component is movable axially, and the second retraction component is rotatable.

10. The medication delivery device of claim 1, wherein the visual indicator is angularly offset from the window at a first state, and is rotatably moved at the completion of the injection event to align the visual indicator with the window.

11. The medication delivery device of any one of claims 1-10, wherein a material of the housing defines the window.

12. The medication delivery device of any one of claims 1-11, further comprising a label affixed to the housing, wherein the label defines the window.

13. The medication delivery device of any one of claims 1-12, wherein the visual indicator comprises at least one of a color, a graphic image, a text, or a symbol.

14. The medication delivery device of any one of claims 1-13, wherein the housing comprises a tubular portion, and wherein the window extends at least 270 degrees circumferentially around the tubular portion.

15. A medication delivery device comprising: a housing having a length extending in an axial direction between a proximal end and a distal end, the housing defining a window; a syringe of medication including a needle that is placeable proximally of said housing proximal end at least during an injection event, said syringe including a syringe barrel and a sealing plunger, said sealing plunger in sealing engagement with said syringe barrel; a drive mechanism within said housing that is configured to advance the syringe proximally so that the outlet is disposed beyond the proximal end, and to advance said sealing plunger proximally within said syringe barrel to force medication from the syringe needle during the injection event; and a syringe retraction mechanism coupled to the syringe, wherein when triggered the syringe retraction mechanism is configured to retract the syringe and the outlet of the syringe distally within the housing after the medication is forced from the syringe needle, the syringe retraction mechanism comprising a retraction component configured to move distally relative to the housing and stop when the outlet of the syringe is within the housing, wherein the retraction component comprises a visual indicator that is not visible through the window prior to the injection event and is visible through the window as indication of a completion of the injection event.

16. The medication delivery device of claim 15, wherein the visual indicator is a first visual indicator, the device further comprising a second visual indicator that is visible through the window prior to the injection event and is not visible through the window as indication of the completion of the injection event.

17. The medication delivery device of claim 15, wherein the retraction component is a first retraction component, and the device further comprises a second window and the syringe retraction mechanism further comprises a second retraction component having a second visual indicator, wherein the visual indicator is associated with the first retraction component, wherein the second visual indicator is not visible through the second window prior to a startof the injection event, and is visible through the second window as indication of the completion of medication delivery of the injection event, the visibility of the second visual indicator is prior to the visibility of the visual indicator in the window.

18. A method of treatment of a disease with a medication delivery device, comprising: providing a medication delivery device, wherein the medication delivery device includes a housing defining a window and having a length extending in an axial direction between a proximal end and a distal end, a container of medication including an outlet that is placeable proximally of said housing proximal end at least during an injection event, said container including a container housing and a sealing plunger, said sealing plunger in sealing engagement with said container housing, a drive mechanism within said housing that is configured to advance said sealing plunger proximally within said container to force medication from the container outlet during the injection event, a container retraction mechanism coupled to the container, wherein when triggered the container retraction mechanism is configured to retract the outlet of the container distally within the housing after the medication is forced from the container outlet, the container retraction mechanism comprising a retraction component configured to stop moving or start moving at a start of retraction, wherein the retraction component comprises a visual indicator that is not visible through the window when the medication delivery device is in a first state of device operation, and is visible through the window when the medication delivery device is in a second state of device operation; placing the outlet of the medication delivery device at a treatment site while the medication delivery device is in the first state of device operation; actuating the medication delivery device to inject the medication from the medication delivery device to the treatment site, and to switch the medication delivery device from the first state of device operation to the second state of device operation; observing the window to determine when the visual indicator becomes visible through the window for an operational status of said device; and when the visual indicator becomes visible through the window, removing the medication delivery device from the treatment site.

19. The method of claim 18, wherein the visual indicator is a first visual indicator, the medication delivery device further comprising a second visual indicator that is visible through the window when the medication delivery device is in the first state of deviceoperation and is not visible through the window when the medication delivery device is in the second state of device operation.

20. The method of claim 18, wherein the visual indicator is a first visual indicator and the window is a first window, the medication delivery device further comprising a second window and a second visual indicator that is not visible through the second window when the medication delivery device is in the first state of device operation and is visible through the second window at the start of retraction, wherein the medication delivery device is configured such that after the container retraction mechanism is triggered, the second visual indicator becomes visible through the second window prior to when the first visual indicator becomes visible through the first window, the method further comprising observing the second window to determine when the second visual indicator becomes visible through the second window, and wherein the removing step is not implemented until after the first visual indicator is visible through the first window and the second visual indicator is visible through the second window.

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