Drug implant delivery device

Abstract

A drug implant delivery device includes a needle; an implant guide comprising a channel that is coaxial with the needle and configured to receive a drug implant; a gate configured to releasably limit the drug implant from moving into the needle; a barrel; a spring-loaded assembly comprising an elastomeric component received in the barrel and a stylet extending coaxially with the channel; and an actuator comprising: a first arm operably coupled to the gate, and a second arm releasably engaged with the spring-loaded assembly, wherein the actuator is configured such that actuation of the actuator causes the first arm to move the gate such that the drug implant can be moved into the needle and the second arm to disengage from the spring-loaded assembly such that the stylet translates to move the drug implant through the needle and into an injection site.

Description

DRUG IMPLANT DELIVERY DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Patent Application No. 63 / 711,812, filed October 25, 2024, which is incorporated herein by reference in its entirety.FIELD

[0002] This disclosure relates generally to implantation of solid drug implants / depots and, more specifically, to ocular drug implants.BACKGROUND

[0003] Drug implants are used to slowly release drug over extended period compared to drugs that are injected or orally administered. Drug implants provide the benefit of reducing the number of drug administrations (dosing frequency) and also mitigate spikes in drug concentration. Drug implants have been widely used in treatment of back of eye disorders such as diabetic macular edema, uveitis. Several drug implants candidates are in development for treatment of other eye disorders such as age-related macular degeneration and other inflammatory conditions. Several drug implants administered parenterally are also available.

[0004] Applicators are devices used to enable implantation of drug implants. These applicators involve administration of a cylindrical implant or multiple implants, which are placed in a cylindrical or near-cylindrical channel. This channel is coaxial with a needle. The implant is translated along this axis from the storage position to past the needle tip by a stylet. Axial translation of the stylet is either manual (axially pushing the style) or by a stored energy source such as a type of spring (compression, constant force, etc.), the release of this energy is typically using a button pushed by the user (clinician) similar to some autoinjectors used in administration of injectable drugs.

[0005] The applicator as taught by US 6,899,717 B2, US 7,090,681 B2 and US 7,468,065 B2 is widely used applicator for administration of an eye implant. It is widely reported in the literature that this design results in large variability in the velocity with which the implant is expelled from the needle. The design relies heavily on viscous drag in the target space (e.g., vitreous fluid in the eye) to slow it down. However, differences in constitution of the vitreousfluid and variability in the surgeon’s technique in pushing the button results in uncertainty with implantation, including uncertainty with location of the implant, and / or injury to the patient caused by the implantation procedure involved. In addition, the user is not able to visualize presence of implant prior to insertion of the needle and can only see it after the implant has left the needle at or near the target implantation site.

[0006] The above applicator does enable a single momentary user input to actuate implantation, which by itself is beneficial feature in simplifying the implantation, as compared to the manual applicator disclosed in patents US 2015 / 0238745 Al and US 9,849,027 B2, both which teach an applicator that requires the stylet to be manually advanced in the axial direction.

[0007] Manual translation of stylet has a benefit of slow, gentle deployment of the implant which makes the location of the implant deterministic and minimizes damage to the implant. Slow speed of axial translation of the implant within the applicator may be an important requirement. The small size of these implants offers negligible resistance to force translating it to the needle tip. Therefore, even a weak conventional (e.g., compression) spring may result in a high translation speed. This problem has been addressed in US 2022 / 0331156 Al by use of a dampener in between the spring and the stylet pushing the implant. The dampener reduces the speed by which the stylet and hence the speed of translation of the implant. The dampener is a vented cylinder where a compressible component (air) acts as a dampener. The size of the vent modulates the degree of dampening. In autoinjectors used for injection of injectable drugs, the dampening of the spring force is provided by force for the injecting the fluid (injectable drug) through the needle, force to compress\ the plunger stopper, and the friction of elastomeric component sliding inside a lubricated barrel. However, the absence of injectable fluid with solid implants, required the invention as taught by US 2022 / 0331156 Al to use a vented compressible air dampener to slow down the decompression of the spring.

[0008] Another dynamic when an elastomeric component is sliding in a lubricated (or lubrication-free) barrel is the concept of the break-loose force as shown in Figure 1. The force to dislodge the elastomeric component (stopper, o-ring, etc) from its rest or initial state in the barrel is significantly higher than force required for the elastomeric component to glide within the barrel. This would mean that the spring force initially has to be much higher than required to provide this break-loose force. The invention described in US 2022 / 0331156 Al requires the vented dampener to accommodate a higher spring force to accommodate thishigh break-loose force. The invention in US 20230103975A1 has a rotary dampener containing oil, the viscosity of which dictates the extent of dampening and hence the

[0009] To the best of our understanding, applicators in the prior art involve custom needle cannula; i.e., needle cannula different than hypodermic needles. In addition, this architecture involves complex needle subassemblies to a) secure the needle cannula and b) align the axial of the lumen of needle cannula with that of the channel containing the implant. This design requires custom needle manufacturing and makes the needle inseparable from rest of the applicator device. This also makes it challenging to conduct needle specific tests such as for ocular irritation, intravitreal irritation, endotoxin testing, subvisible particulates testing, etc.

[0010] In order to prevent premature actuation of implantation, designs in the prior art have a grenade pin design (involving removal of a component to make a button free to actuate) or have a feature encoded into the cap covering the needle that also acts as a physical barrier to actuation until the cap is removed.

[0011] In the prior art, the implant’s axial position in the channel is secured by a trocar pin in the needle that physically obstructs the implant’s path out through the needle - this is the applicator design in drug Yutiq®. In some designs, the implant’s path is blocked partially by a feature that is removed out of the way upon actuation as shown in US 20230103975A1 (active design). Alternatively, this aforementioned feature is designed to be compliant as shown in BE 1027526B1 and US 5201779, which along with the design described in EP 1666084A1, involve moving the constraining element out of the way simply by having the implant translate axially when pushed by the stylet (passive design).SUMMARY

[0012] According to various aspects, devices and methods described herein overcome or ameliorate one or more of the disadvantages of prior art. According to an aspect, a drug implant delivery device (also referred to herein as an applicator) enables a user to administer a cylindrical implant to a subject. The device can be configured to enables the user to insert the implant into the device just prior to implantation. The device may enable controlled, gentle implantation. Manual and button- actuated embodiments are disclosed herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0014] FIG. 1 illustrates conventional break loose and glide forces;

[0015] FIGS. 2A and 2B illustrate exemplary manual and button-actuated device;

[0016] FIGS. 3A and 3B illustrate exploded views of the manual and button- actuated devices of FIGS. 2A and 2B;

[0017] FIGS. 4A-E illustrate exemplary steps of operation of a button-actuated device;

[0018] FIGS. 5A-D illustrate exemplary steps of operation of a manually- actuated device;

[0019] FIGS. 6 A and 6B illustrate an exemplary insertion of an implant into an exemplary device;

[0020] FIG. 7 illustrates an exemplary visualization of an implant loaded into an exemplary device;

[0021] FIGS. 8A and 8B illustrate an exemplary cap removal;

[0022] FIGS. 9 A and 9B illustrate an exemplary mechanism for preventing premature injection button actuation;

[0023] FIGS. 10A and 10B illustrate an exemplary configuration for unidirectional translation of a slider;

[0024] FIGS. 11 A and 1 IB illustrate an exemplary mechanism for releasing a spring;

[0025] FIGS. 12A and 12B illustrate an exemplary opening of implant retention feature;

[0026] FIG. 13 illustrates the state of various exemplary components at the time of implant release at target site;

[0027] FIGS. 14A-C illustrate an exemplary break loose upon actuation process for an injection button;

[0028] FIGS. 15A-C illustrate sectional views of the moving of an implant retention feature;

[0029] FIGS. 16A-C illustrate an example of an end cap placement to complete device assembly;

[0030] FIGS. 17A and 17B illustrate an exemplary housing and cover;

[0031] FIGS. 18A-D illustrate an exemplary window with cored design;

[0032] FIG. 19 illustrates exemplary aspects of an actuator;

[0033] FIG. 20 illustrates exemplary aspects of a slider; and

[0034] FIG. 21 illustrates exemplary aspects of a stylet subassembly.DETAILED DESCRIPTION

[0035] According to various aspects, devices and methods described herein include a drug implant delivery device that has have one or more of the following design attributes:• A channel coaxial with needle lumen within which a cylindrical implant is stored and in which it translates at the time of implantation.• An axially translatable stylet used to push the cylindrical implant from its storage position to post the needle tip• An actuation feature to initiate axial translation of stylet and hence the implant.• A safety feature that prevents premature / unintended actuation of the actuation feature• Needle and needle subassembly• Constraining feature(s) to secure implant during storage• Configuration that enables placement implant within applicator for storage • Mechanism to translate the stylet and hence the implant• Ability to visualize implant prior to implantation and during storage

[0036] In the following description of the disclosure and embodiments, reference is made to the accompanying drawings in which are shown, by way of illustration, specific embodimentsthat can be practiced. It is to be understood that other embodiments and examples can be practiced, and changes can be made, without departing from the scope of the disclosure.

[0037] In addition, it is also to be understood that the singular forms “a,” “an,” and “the” used in the following description are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and / or,” as used herein, refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes,” “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units, but do not preclude the presence of addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0038] This disclosure introduces examples of devices configured to assist in implantation of drug implants, such as cylindrical drug implants. FIG. 2A illustrates an exemplary manually-operated device and FIG. 2B illustrates an exemplary button- actuated device. The devices of FIG. 2A and 2B can be loaded with a single drug implant or with multiple drug implants (e.g., two or more implants, three or more implants, four or more implants, five or more implants, six or more implants, seven or more implants, eight or more implants, nine or more implants, ten or more implants, etc.). The devices can be pre-loaded with the one or more implants or can be user loaded with the one or more implants at the situs of a subject into one or more of the implants are to be implanted.

[0039] The devices of FIG. 2A and 2B have common components and features such as window 9 to visualize the implant and as a cover after placement of the implant, a slider 10 which can be used to unlock the device to prevent premature actuation / use, housing 3 and cover 2, needle 5, cap 4 and an indicator window 20 confirming end of procedure and to distinguish between a used and unused device. The two embodiments differ in mode of operation - manual push of plunger rod 19 to inject the implant akin to a syringe. This manual embodiment offers the clinician complete control of the injection speed. The button actuated embodiment in FIG. 2B has an actuator 16 and an end cap 14.

[0040] FIGS. 3A and 3B show exploded views of the manual injection device (FIG. 3A) and the button actuated device (FIG. 3B) showing externally visible as well as internal components without housing 3 and cover 2. Common to both embodiments include needle 5,cap 4, gate 6, lower guide 7, upper guide 8, window 9, stylet 11. The manual embodiment has a compound gear 18, whose larger gear meshes with drive rod 17 and the smaller gear, whose teeth meshes with rack on plunger rod 19. The gear amplifies the user injection stroke on plunger rod 19 causing drive rod 17, which has stylet 11 press fit into it. This axial motion forces the gate 6 to open and move retention feature in the channel defined by the upper guide 8 and lower guide 7 in which the implant (not shown) is stored. This channel is coaxial with and has same or smaller diameter than the lumen diameter of the needle cannula 5 that is serially positioned to the channel. Continued axial translation of the drive rod 17, and hence the stylet 11, pushes the implant out of the needle 5. In the button- actuated embodiment (FIG.3B), the energy to do the work necessary to push the implant out of the device is provided by a compression spring 13. The spring 13 pushes against the stylet subassembly 12, which incorporate stylet 11. This spring 13 is maintained in its compressed state by a feature on the actuator 16 prior to actuation. The stylet subassembly 12 contains an elastomeric ring (o-ring) or a stopper with an axial hole, which is configured to axially translate within barrel 15. The barrel may be lubricated internally or could be constructed to be lubrication-free. The elastomer and the barrel within which it slides provides a frictional dampener to further decrease the speed at which the implant 1 is placed at its target site. The actuator 16 is unable to be actuated unless slider 10 is in the unlock position. The gate 6 in the actuator 16 embodiment is moved out of the channel defined by upper guide 8 and lower guide 7 by depression of an actuator button 16-1. Alternatively, the device could be configured to have the forward motion of the implant move the gate 6 or have an embodiment where the retention is based on electrostatic attraction between the implant 1 and device components in contact with it during storage. The spring 13 remains compressed between the stylet subassembly 12 and an end cap 14. The components in the button actuated embodiment common to the manual embodiment function in a manner identical as described above for the manual embodiment.

[0041] Shown in FIGS. 4A-E are various stages of operation of the button actuated embodiment. FIG. 4A is when the implant is stored within the device. The cap 4 is removed from the device by turning or pulling or combination of both in FIG. 4B. The device cannot be actuated in this stage. The slider 10 is moved from the locked to unlocked position in FIG.4C. The actuator 16 is now in the depressed position actuating the release of the spring in FIG. 4D. The implant 1 is pushed out of the needle by the stylet in FIG. 4E.

[0042] Shown in FIGS. 5A-D are various stages of operation of the manual embodiment. FIG. 5A is when the implant is stored within the device. The cap 4 is removed from the device by turning or pulling or combination of both in FIG. 5B. The device cannot be actuated in this stage. The slider 10 is moved from the locked to unlocked position in FIG.5C. The plunger rod 19 is now in the depressed position upon receipt of an axial input from the user in FIG. 5D. The implant 1 is pushed out of the needle by the stylet.

[0043] FIGS. 6 A and 6B show loading of the implant within the device, and is common for both embodiments. Loading can be done by a surgeon or other end-user prior or by a supplier prior to packaging the device as a pre-loaded device. The cover 2 and housing 3 have an opening framed by upper guide 8, which comprises an aperture 8-1 that is configured to receive a window 9. The window 9 includes a central recess 9-6 opens to the outside of the device when the window 9 is received in the upper guide 8 (the opening being visible in FIG.6 A). The base 9-1 of the recess 9-6 (see FIG. 18) is closed and transparent to enable viewing of the implant 1 beneath the window 9. In FIG. 6A, the implant 1 is loaded (e.g., by a surgeon or other user just prior to implantation or at a supplier facility) into the device in a direction 52 that is orthogonal to the longitudinal axis 50 of the device. Once the implant 1 is loaded, it is received in a ‘U’ shaped channel formed by the lower guide 7 (not shown). The window 9 is pressed (e.g., by a surgeon or other user just prior to implantation or at a supplier facility) within the frame created by the upper guide 8. The window 9 may be pressed until an outer rim 9-5 of the window 9 is flush with an outer surface 54 of the device. This novel design simplifies insertion of the implant into the device. This also enables a mode of operation where the implant may be loaded by a clinician into the device, which was received sterile, immediately prior to implantation at the situs of the subject. In other cases, a pharmaceutical company would place the implant in a clean, controlled environment. The device with the implant would be placed in a sealed package, such as blister package or Tyvek pouch or the like. This sealed package with the device and implant within it would be sterilized using a modality compatible with the implant to ensure that the device and the implant are sterile when received by the clinician.

[0044] FIG. 7 shows the implant 1 through window 9. Having such a window enables the pharmaceutical company to confirm presence as part of quality check and reassures the user / clinician of presence of the implant prior to implantation.

[0045] FIG. 8A and 8B show removal of cap 4. It is designed to enable removal either by axially pulling or twisting or a combination of both.

[0046] FIGS. 9A and 9B illustrates how the slider 10 prevents depression of the actuator 16. FIG. 9A is the ‘as received’ by the user state. Feature 10-3 on the slider 10 blocks feature 16-6 on the actuator 16; this prevents depression of the actuator 16. However, once the slider 10 is moved from the lock to unlock position (FIG. 9B), feature 16-6 is no longer obstructed and the actuator 16 can now be depressed.

[0047] FIGS. 10A and 10B show features involved in the retention and locking of the slider 10. FIG. 10A is ‘as received’ by the user. Feature 10-2 on the slider is placed in one of two identical slots 3-4 on the housing 3. The design of the slots is such that the user has to provide active input to move the slider 10 (i.e., no accidental motion) and prevent reverse motion of the slider 10 (cannot move from unlocked to locked state).

[0048] FIGS. 11A and 11B show states of the actuator 16 as it interacts with the stylet subassembly 12. FIG. 11A shows the actuator 16 having collar 16-5 of a proximal arm 16-11 resting in a slot 12-4 in the stylet subassembly 12 preventing the axial decompression of the spring 13. The actuator 16 is able to pivot about a circular hole 16-4. A pin in the housing 3 mates with this hole 16-4. In FIG. 1 IB, when the actuator 16 receives a user input on button 16-1 towards the axis of the device pushing the button 16-1 down, the retention feature 16-5 is raised up as the actuator 16 pivots about hole 16-4, moving out of the slot 12-4, which enables the spring 13 to decompress. Feature 16-3 helps latch the actuator 16 in its depressed state once the user presses it. This latching may also produce an audible sound providing user with an audible and tactile cue that the implantation has commenced.

[0049] FIGS. 12A and 12B shows interaction of the actuator 16 with gate 6 before and after actuator 16 is depressed by the user. In FIG. 12A, implant retention bump 6-1 prevents the implant 1 from translating out of the needle. This implant retention bump 6-1 obstructs the channel formed by upper guide 8 and lower guide 7 with a small cut out in the lower guide 7 for the implant retention bump 6-1 on gate 6. In FIG. 12B, when the user applies a force on button 16-1 to depress it, the button arm 16-2 pushes the gate 6 down and the implant retention bump 6-1 out of the way of the now translating implant 1. It is envisioned that a weak beam in gate 6 could enable the same outcome by the translating implant (passive design) without active displacement of the gate 6 by the actuator 16.

[0050] FIG. 13 should a view of the end of the implantation procedure where decompressed spring 13 and style subassembly are bottomed out and the implant 1 has exited the needle 5.

[0051] FIGS. 14A-C illustrate how the device design can enable incorporation of a weak spring. A weak spring is important in applications where gentle implantation is desired, such as the eye. Separately, a frictional dampener is used involving an elastomeric component gliding on a lubricated and non-lubricated barrel. Without requiring the spring force to overcoming break loose force inherent in gliding elastomeric components, the device has unique design where depression of the button also displaces the elastomeric component enough such that it operates in the zone where only the lower and more predictable glide force is in play. FIG. 14A is prior to depression of the actuator 16. The collar 16-5 of the actuator 16 is positioned in the slot of the stylet subassembly 12. Upon depression of a button of the actuator 16, the actuator 16 pivots about pin 60 and collar 16-5 begins to move out of the slot of the stylet subassembly. As the collar 16-5 moves in this manner, it pushes on a collar 12-3 of the stylet subassembly 12, causing the stylet subassembly 12 (and hence its elastomeric component) to axially translated proximally by a small distance to overcome the break loose force, as shown in FIG. 14B. This enables the a spring to predictably and at low speed push implant 1 out of the device into the target site in FIG. 14C once the collar 16-5 moves free of collar 12-3. Break loose force is known to be highly variable and can be in some cases an order of magnitude higher than the glide force. This presents with uncertainty potentially resulting in failure. High break loose force is known to trigger occlusion alarms in syringe pumps.

[0052] FIGS. 15A-C is sectioned view showing retention bump feature 6-1 of the gate 6 obstructing the path of the implant 1. The ‘as received’ state is shown in FIG. 15A. in FIG.15B, the actuator 16 is depressed, moving retention bump feature 6-1 out of the path of the axially translating implant 1 pushed by stylet 11. The implant 1 exits the device in FIG. 15C.

[0053] FIGS. 16A-C shows feature of the end cap 14 and its assembly to the housing and cover. The features shown are to enable unidirectional assembly and prevention of removal of the end cap 14 after assembly.

[0054] FIG. 17A and 17B show feature of the housing 3 and cover 2. Pins / posts 3-1 mate with undersized holes 2-1 for an interference fit at final assembly to hold the two components together without the need for adhesives. The actuator 16 hole 16-4 is placed on post 3-4around which it is design to pivot. Stylet guide features 2-2 and 3-2 on the cover and housing provide support to the stylet 11 prior to and during operation of the device.

[0055] FIGS. 18A-C shows the window 9. The window 9 serves two functions - it provides a visual to the implant 1 during manufacturing and storage and to the user during implantation. For installation, the window 9 is pressed into upper guide 8 frame. The window 9 can be installed by a user prior to use of the device for implantation or can be installed at a supplier facility prior to packaging. The window 9 may have a press-fit engagement with the upper guide 8 to retain the window 9 within the upper guide 8 and / or may have one or more retention features 9-4. The window 9 has a unique cored design (recess 9-6) that avoids (core out) excess material / thickness between surfaces 9-1 and 9-2. This minimizes attenuation of light (important in darker settings) and minimizes visual artifacts from thick components made from clear material. In addition, surface 9-1 can be modified to provide additional magnification if desired. Surface 9-2 also acts as a retaining surface for the implant 1 and radially constrains it in conjunction with the lower guide 7 during storage. It is conceivable that the window 9 is treated to provide electrostatic or weak attraction force to axially constrain the implant 1. Lead in 9-3 is provided to ensure the stylet 11 does not get jammed during device operation as it enters implant 1 storage region.

[0056] Actuator 16 and afore-referenced features are shown in FIG. 19.

[0057] Slider 10 and afore-referenced features are shown in FIG. 20.

[0058] Stylet subassembly 12 is shown in FIG. 21 showing elastomeric component 12-1, collar 12-3 that interface with the spring 13. Stylet 11 is press fit into stylet holder 12-2; this also appears in indicator window 20 at the end of procedure and may be color to provide contrast relative to the cover 2 and housing 3.

[0059] The following is a list of exemplary embodiments:

[0060] Embodiment 1: A drug implant delivery device, comprising:a needle;an implant guide comprising a channel that is coaxial with the needle and configured to receive a drug implant;a gate configured to releasably limit the drug implant from moving into the needle;a barrel;a spring-loaded assembly comprising an elastomeric component received in the barrel and a stylet extending coaxially with the channel; andan actuator comprising:a first arm operably coupled to the gate, anda second arm releasably engaged with the spring-loaded assembly, wherein the actuator is configured such that actuation of the actuator causes the first arm to move the gate such that the drug implant can be moved into the needle and the second arm to disengage from the spring-loaded assembly such that the stylet translates to move the drug implant through the needle and into an injection site.

[0061] Embodiment 2: The device of embodiment 1, wherein actuating the actuator simultaneously causes the first arm to move the gate and the second arm to disengage from the spring-loaded assembly.

[0062] Embodiment 3: The device of embodiment 1 or 2, comprising a user-engageable lock configured such that moving the lock from a locked position to an unlocked position allows the actuator to be actuated.

[0063] Embodiment 4: The device of any one of embodiments 1-3, comprising a cap configured to removably cover the needle.

[0064] Embodiment 5: The device of any one of embodiments 1-4, wherein the drug implant is pre-loaded into the device.

[0065] Embodiment 6: The device of any one of embodiments 1-4, wherein the drug implant is user-loadable into the device.

[0066] Embodiment 7: The device of any one of embodiments 1-6, wherein the drug implant is loaded into the device in a direction that is orthogonal to a longitudinal axis of the device.

[0067] Embodiment 8: The device of any one of embodiments 1-7, comprising a window configured for viewing the drug implant within the implant guide.

[0068] Embodiment 9: The device of embodiment 8, wherein the window is insertable into an aperture through which the drug implant is loaded.

[0069] Embodiment 10: The device of any one of embodiments 1-9, wherein the elastomeric component is configured to translate under action of a spring, the translation being dampened by engagement between the elastomeric component and the barrel.

[0070] Embodiment 11: A drug implant device, comprising:a needle;an implant guide that is coaxial with the needle and configured to receive a drug implant;a window configured for viewing the drug implant within the implant guide; and a stylet configured to move the drug implant through the needle and into an injection site.

[0071] Embodiment 12: The device of embodiment 11, wherein the window comprises a recess that opens to an outside of the device.

[0072] Embodiment 13: The device of embodiment 11 or 12, wherein the window is installable by a user.

[0073] Embodiment 14: The device of any one of embodiments 11-13, wherein the drug implant is pre-loaded into the device.

[0074] Embodiment 15: The device of any one of embodiments 11-13, wherein the drug implant is user-loadable into the device.

[0075] Embodiment 16: The device of any one of embodiments 11-15, wherein the drug implant is loaded into the device in a direction that is orthogonal to a longitudinal axis of the device.

[0076] Embodiment 17: The device of any one of embodiments 11-17, wherein the window is configured to be installed into an aperture of the device through which the drug implant passes when loaded into the device.

[0077] Embodiment 18: The device of embodiment 17, wherein the window is installed into the aperture in the same direction that the drug implant passes when loaded into the device.

[0078] Embodiment 19: A drug implant device, comprising:a needle;an implant guide that is coaxial with the needle and configured to receive a drug implanta barrel;a stylet assembly comprising an elastomeric component that engages the barrel and a stylet that extends coaxially with the implant guide; anda spring operably connected to the stylet assembly,wherein the elastomeric component is configured to translate under action of the spring, the translation being dampened by engagement between the elastomeric component and the barrel, such that the stylet assembly moves the drug implant through the needle and into an injection site.

[0079] Embodiment 20: The device of embodiment 19, comprising an actuator configured to releasably engage the elastomeric component.

[0080] Embodiment 21: The device of embodiment 20, wherein actuation of the actuator releases the elastomeric component, wherein the actuator is configured to move the elastomeric component prior to releasing the elastomeric component to overcome a break loose force between the elastomeric component and the barrel.

[0081] Embodiment 22: The device of embodiment 21, wherein the actuator is configured to move the elastomeric component proximally prior to releasing the elastomeric component.

[0082] Embodiment 23: The device of any one of embodiments 20-22, wherein the actuator comprises a collar that is received in a slot of the stylet assembly to prevent the stylet assembly from translating.

[0083] Embodiment 24: The device of embodiment 23, wherein the drug implant is cylindrical.

[0084] Embodiment 25: The device of any one of embodiments 20-24, wherein device is loaded with multiple drug implants.

[0085] Embodiment 26: A method for delivering a drug implant into a subject, the method comprising:at a situs of a patient, loading the drug implant into a drug implant delivery device; inserting a needle of the device into the subject; andactuating a delivery mechanism of the device to deliver the drug implant through the needle into the subject.

[0086] Embodiment 27: The method of embodiment 26, wherein loading the drug implant into the device comprises loading the drug implant into the device in a direction that is orthogonal to a longitudinal axis of the device.

[0087] Embodiment 28: The method of embodiment 26 or embodiment 27, wherein the drug implant is loaded through an aperture of the device, and the method comprises, prior to inserting the needle into the subject, inserting a window into the aperture.

[0088] It would be understood to those skilled in the art that additional manufacturing controls to ensure compliance with regulatory and safety requirements for use in applications such as in ophthalmology such as control of sub visible particulates, endotoxin content and other production controls; such controls are anticipated with the disclosed devices.

[0089] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0090] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood asbeing included within the scope of the disclosure and examples as defined by the claims. Finally, the entire disclosure of the patents and publications referred to in this application are hereby incorporated herein by reference.

Claims

CLAIMS1. A drug implant delivery device, comprising:a needle;an implant guide comprising a channel that is coaxial with the needle and configured to receive a drug implant;a gate configured to releasably limit the drug implant from moving into the needle; a barrel;a spring-loaded assembly comprising an elastomeric component received in the barrel and a stylet extending coaxially with the channel; andan actuator comprising:a first arm operably coupled to the gate, anda second arm releasably engaged with the spring-loaded assembly, wherein the actuator is configured such that actuation of the actuator causes the first arm to move the gate such that the drug implant can be moved into the needle and the second arm to disengage from the spring-loaded assembly such that the stylet translates to move the drug implant through the needle and into an injection site.

2. The device of claim 1, wherein actuating the actuator simultaneously causes the first arm to move the gate and the second arm to disengage from the spring-loaded assembly.

3. The device of claim 1, comprising a user-engageable lock configured such that moving the lock from a locked position to an unlocked position allows the actuator to be actuated.

4. The device of claim 1, comprising a cap configured to removably cover the needle.

5. The device of claim 1, wherein the drug implant is pre-loaded into the device.

6. The device of claim 1, wherein the drug implant is user-loadable into the device.

7. The device of claim 1, wherein the drug implant is loaded into the device in a direction that is orthogonal to a longitudinal axis of the device.

8. The device of claim 1, comprising a window configured for viewing the drug implant within the implant guide.

9. The device of claim 8, wherein the window is insertable into an aperture through which the drug implant is loaded.

10. The device of claim 1, wherein the elastomeric component is configured to translate under action of a spring, the translation being dampened by engagement between the elastomeric component and the barrel.

11. A drug implant device, comprising:a needle;an implant guide that is coaxial with the needle and configured to receive a drug implant;a window configured for viewing the drug implant within the implant guide; and a stylet configured to move the drug implant through the needle and into an injection site.

12. The device of claim 11, wherein the window comprises a recess that opens to an outside of the device.

13. The device of claim 11, wherein the window is installable by a user.

14. The device of claim 11, wherein the drug implant is pre-loaded into the device.

15. The device of claim 11, wherein the drug implant is user-loadable into the device.

16. The device of claim 11, wherein the drug implant is loaded into the device in a direction that is orthogonal to a longitudinal axis of the device.

17. The device of claim 11, wherein the window is configured to be installed into an aperture of the device through which the drug implant passes when loaded into the device.

18. The device of claim 17, wherein the window is installed into the aperture in the same direction that the drug implant passes when loaded into the device.

19. A drug implant device, comprising:a needle;an implant guide that is coaxial with the needle and configured to receive a drug implanta barrel;a stylet assembly comprising an elastomeric component that engages the barrel and a stylet that extends coaxially with the implant guide; anda spring operably connected to the stylet assembly,wherein the elastomeric component is configured to translate under action of the spring, the translation being dampened by engagement between the elastomeric component and the barrel, such that the stylet assembly moves the drug implant through the needle and into an injection site.

20. The device of claim 19, comprising an actuator configured to releasably engage the elastomeric component.

21. The device of claim 20, wherein actuation of the actuator releases the elastomeric component, wherein the actuator is configured to move the elastomeric component prior to releasing the elastomeric component to overcome a break loose force between the elastomeric component and the barrel.

22. The device of claim 21, wherein the actuator is configured to move the elastomeric component proximally prior to releasing the elastomeric component.

23. The device of claim 20, wherein the actuator comprises a collar that is received in a slot of the stylet assembly to prevent the stylet assembly from translating.

24. The device of claim 23, wherein the drug implant is cylindrical.

25. The device of claim 20, wherein device is loaded with multiple drug implants.

26. A method for delivering a drug implant into a subject, the method comprising: at a situs of a patient, loading the drug implant into a drug implant delivery device; inserting a needle of the device into the subject; andactuating a delivery mechanism of the device to deliver the drug implant through the needle into the subject.

27. The method of claim 26, wherein loading the drug implant into the device comprises loading the drug implant into the device in a direction that is orthogonal to a longitudinal axis of the device.

28. The method of claim 26, wherein the drug implant is loaded through an aperture of the device, and the method comprises, prior to inserting the needle into the subject, inserting a window into the aperture.

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