Injector for delivering the implant

Abstract

The injector (100) includes a push rod, a magazine tube, a gate, a cannula (122), and an actuator (170). The magazine tube has a lumen extending from its inlet to its outlet. The magazine tube slidably receives at least one implant therein. The gate has a closed configuration that covers the outlet of the magazine tube and an open configuration that does not cover the outlet of the magazine tube. The cannula (122) has a distal end (123) configured to be inserted into the eye. The lumen of the cannula (122) is in fluid communication with the lumen of the magazine tube when the gate is in the open configuration. Actuation of the actuator (170) moves the gate from the closed configuration to the open configuration, causing translation of the push rod through the magazine tube and the cannula (122).

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Patent Application No. 63 / 251,799, filed October 4, 2021, and U.S. Patent Application No. 63 / 359,281, filed July 8, 2022, the entire disclosures of which are incorporated herein by reference for all purposes.

[0002] The present disclosure relates generally to injectors, and more particularly, to injectors for delivering one or more implants. [Background technology]

[0003] The main problem in treating eye diseases is to introduce drugs or therapeutic agents into the eye and to maintain these drugs or agents in therapeutically effective concentrations in the eye for the required period of time. Systemic administration may not be an ideal solution because unacceptably high levels of systemic administration are often required to achieve effective intraocular concentrations, along with an increased incidence of unacceptable side effects of the drug. Simple eye drops or paintings are often not an acceptable alternative because the drug may be quickly washed out by lacrimal action or may enter the systemic circulation from the eye. Suprachoroidal injection of drug solutions has also been performed, but the effectiveness of the drug is short-lived. Such methods make it difficult to maintain therapeutic levels of the drug for an appropriate period of time. Efforts to address this problem have led to the development of drug delivery devices, or implants, that can be implanted in the eye so that a controlled amount of the desired drug can be constantly released over a period of days, weeks, or months.

[0004] There are various sites in the eye for implantation of drug delivery devices or implants, such as the posterior part of the eye, the anterior or posterior chamber, or other areas of the eye, including the intraretinal, subretinal, intrachoroidal, suprachoroidal, intrascleral, episcleral, subconjunctival, intercorneal or epicorneal space. Regardless of the desired location of implantation, typical implantation methods all require relatively invasive surgical procedures, pose the risk of undue trauma to the eye, and require excessive handling of the implant. For example, in a typical method for intravitreal placement, an incision is made through the sclera and the implant is inserted and attached to the desired location in the vitreous using forceps or other similar manual gripping device. Once attached, the forceps (or gripping device) are removed and the incision is sutured. Alternatively, an incision can be made through the sclera and a trocar can be passed through the incision and the implant can then be delivered through the trocar. Similar methods can be used to deliver implants to other locations, for example, through an incision in the cornea and into the anterior chamber of the eye.

[0005] The drawbacks of such techniques for implant delivery are many. They require extensive handling of the implant, which creates the risk of damaging or contaminating the implant in the process. Many such implants are polymer-based and relatively fragile. If a portion of such an implant is damaged or cut off, the release profile and / or effective therapeutic dose delivered by the implant once placed will be significantly altered. In addition, it may be difficult to achieve reproducible placement between individual patients using these methods. Also important is the fact that such techniques may require a scleral opening large enough to require suturing. Thus, such techniques are typically performed in a surgical setting.

[0006] Simpler, more convenient, less invasive, and / or less traumatic means for delivering implants to the eye are desirable. Summary of the Invention

[0007] According to a first embodiment herein, the present disclosure provides an injector including a housing, a push rod at least partially disposed within the housing, a magazine tube disposed within the housing, a gate disposed within the housing, a cannula disposed outside the housing and having a distal end configured to be inserted into an eye, and an actuator. The magazine tube has an inlet, an outlet, and a lumen extending from the inlet to the outlet. The magazine tube is configured to slidably receive at least one implant therein, and the push rod is configured to be slidably received within the lumen of the magazine tube. The gate has a closed configuration covering the outlet of the magazine tube and an open configuration not covering the outlet of the magazine tube. The lumen of the cannula is in fluid communication with the lumen of the magazine tube when the gate is in the open configuration. Actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the push rod through the magazine tube and the cannula.

[0008] In an aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a safety cap configured to be removably coupled to the housing to cover the distal end of the cannula when coupled to the housing, the safety cap including a tab that extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator.

[0009] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the housing has a generally tubular structure having asymmetric fins that include a height that is greater than the height of the remaining length of the housing.

[0010] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the distal end of the cannula is beveled.

[0011] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body is coupled to a spring, the spring including an unextended configuration and an extended configuration, and is biased to the unextended configuration. In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the spring is wound in the unextended configuration. In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator in the undeployed position holds the shuttle body such that the spring is in the extended configuration. In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that actuation of the actuator from the undeployed position to the deployed position releases the shuttle body and allows the spring to resume the unextended configuration. In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that when the actuator is in the undeployed position, the actuator abuts and locks against the shuttle body, and when the actuator is in the deployed position, the actuator does not contact and is disengaged from the shuttle body. In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator is configured to rotate relative to the shuttle body to transition between the undeployed and deployed positions.

[0012] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the magazine tube is configured to hold up to three implants and the injector is configured to deliver the three implants via a single actuation of the actuator.

[0013] In an aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the cannula and the magazine tube are coaxially aligned and a transition gap extends between an outlet of the magazine tube and an inlet of the cannula. In an aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that a portion of the gate is disposed within the transition gap when the gate is in a closed configuration and a portion of the gate is not disposed within the transition gap when the gate is in an open configuration.

[0014] In an aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the housing includes a window formed thereon to enable visual feedback related to translation of the push rod.In an aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, and an exterior surface of the shuttle body includes a status indicator thereon for providing visual feedback through the window.

[0015] In an aspect of the first embodiment, in combination with any other aspect herein, the disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing. A drag wire is attached to the shuttle body. The injector further includes a shuttle reducer disposed within the housing, the shuttle reducer configured to receive the drag wire within its sinusoidal path. In an aspect of the first embodiment, in combination with any other aspect herein, the disclosure provides that the shuttle reducer's sinusoidal path is defined by a plurality of bosses, and interaction between the drag wire and the plurality of bosses creates friction that slows down translation of the shuttle body and the push rod attached thereto. In an aspect of the first embodiment, in combination with any other aspect herein, the disclosure provides that the drag wire is formed from stainless steel and the plurality of bosses is formed from a plastic material.

[0016] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is formed from stainless steel.

[0017] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a rotational damper disposed within the housing, the rotational damper coupled to the push rod and configured to slow down a rate at which the push rod moves within the housing.

[0018] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within a housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.035 inch-pounds, and the injector has an injection speed of 4 to 9 seconds.

[0019] In one aspect of the first embodiment, in combination with any other aspect herein, the disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within a housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.4 pounds force (0.4 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 2.5 to 7.5 seconds.

[0020] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within a housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 1.5 to 6.5 seconds.

[0021] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides a method of preventing or treating an ocular condition or disease of an eye in need of prevention or treatment, comprising administering an implant containing an active pharmaceutical ingredient (API) using an injector of the first embodiment. In some embodiments, the implant is administered to treat a pre-ocular condition. In other embodiments, it may be administered to treat a posterior ocular condition. In some embodiments, the implant is administered to prevent a pre-ocular condition. In other embodiments, it may be administered to prevent a posterior ocular condition.

[0022] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides a method of treating chronic non-infectious uveitis affecting the posterior segment of an eye in need of treatment, comprising administering an implant containing fluocinolone acetonide using the injector of the first embodiment. According to one embodiment, the implant is an intravitreal implant containing about 0.18 mg of fluocinolone acetonide. The implant may also include polyvinyl alcohol, silicone adhesive, polyimide tubing, and may include water.

[0023] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides a method of treating a retinal disease of an eye in need of treatment, comprising administering an implant comprising borolanib using the injector of the first embodiment. According to one embodiment, the implant is an intravitreal implant and comprises about 400 μg to about 2800 μg of borolanib. The implant may also comprise polyvinyl alcohol.

[0024] According to a second embodiment herein, the present disclosure provides a method of delivering at least one implant to an eye using an injector. The injector is positioned near the eye. The injector includes a push rod, a magazine tube having an inlet, an outlet, and a lumen extending from the inlet to the outlet, the magazine tube having at least one implant therein, a gate in a closed configuration covering the outlet of the magazine tube, a cannula, and an actuator. A distal end of the cannula is inserted into eye tissue. The actuator is actuated to deliver at least one implant to eye tissue. Actuation of the actuator moves the gate from a closed configuration to an open configuration in which the gate does not cover the outlet of the magazine tube, and actuation of the actuator also causes translation of the push rod through the magazine tube and the cannula to push the at least one implant.

[0025] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one implant includes exactly three implants.

[0026] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the ocular tissue comprises the vitreous of the eye.

[0027] In one aspect of the second embodiment, in combination with other aspects herein, the present disclosure provides that the lumen of the cannula is in fluid communication with the lumen of the magazine tube when the gate is in an open configuration.

[0028] In one aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the distal end of the cannula is beveled.

[0029] In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to the shuttle body, the shuttle body is coupled to a spring, the spring including an unextended configuration and an extended configuration, and is biased to the unextended configuration. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the spring is wound in the unextended configuration. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator in the undeployed position holds the shuttle body such that the spring is in the extended configuration. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that actuation of the actuator from the undeployed position to the deployed position releases the shuttle body and allows the spring to resume the unextended configuration. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that when the actuator is in the undeployed position, the actuator abuts and locks against the shuttle body, and when the actuator is in the deployed position, the actuator does not contact and is disengaged from the shuttle body.

[0030] In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the cannula and the magazine tube are coaxially aligned and a transition gap extends between an outlet of the magazine tube and an inlet of the cannula. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that a portion of the gate is disposed within the transition gap when the gate is in a closed configuration and a portion of the gate is not disposed within the transition gap when the gate is in an open configuration.

[0031] In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to the shuttle body. The drag wire is attached to the shuttle body. The injector further includes a shuttle reducer that reduces translation of the shuttle body and the push rod attached thereto. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the shuttle reducer includes a plurality of bosses that form a sinusoidal path, and the interaction between the drag wire and the plurality of bosses creates friction. In an aspect of the second embodiment, in combination with any other aspect herein, the present disclosure provides that the drag wire is formed from stainless steel and the plurality of bosses are formed from a plastic material.

[0032] According to a third embodiment of the present disclosure, the present disclosure provides an injector including a housing, a push rod at least partially disposed within the housing, a magazine tube disposed within the housing, a cannula disposed outside the housing and having a distal end configured to be inserted into an eye, and an actuator. The magazine tube has an inlet, an outlet, and a lumen extending from the inlet to the outlet. The magazine tube is configured to slidably receive at least one implant therein, and the push rod is configured to slidably receive within the lumen of the magazine tube. Actuation of the actuator causes translation of the push rod through the magazine tube and the cannula. The magazine tube is configured to hold at least three implants, and the injector is configured to deliver the at least three implants via a single actuation of the actuator. A delivery rate of the at least three implants is controlled such that the delivery rate is between 2 and 12 seconds.

[0033] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a gate disposed within the housing. The gate has a closed configuration that covers the outlet of the magazine tube and an open configuration that does not cover the outlet of the magazine tube. The lumen of the cannula is in fluid communication with the lumen of the magazine tube when the gate is in the open configuration. Actuation of the actuator moves the gate from the closed configuration to the open configuration. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the cannula and the magazine tube are coaxially aligned and a transition gap extends between the outlet of the magazine tube and the inlet of the cannula. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that a portion of the gate is disposed within the transition gap when the gate is in the closed configuration and a portion of the gate is not disposed within the transition gap when the gate is in the open configuration.

[0034] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a safety cap configured to be removably coupled to the housing to cover the distal end of the cannula when coupled to the housing, the safety cap including a tab that extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator.

[0035] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the housing has a generally tubular structure having asymmetric fins that include a height that is greater than the height of the remaining length of the housing.

[0036] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the distal end of the cannula is beveled.

[0037] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body is coupled to a spring, the spring including an unextended configuration and an extended configuration, and is biased to the unextended configuration. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the spring is wound in the unextended configuration. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator in the undeployed position holds the shuttle body such that the spring is in the extended configuration. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that actuation of the actuator from the undeployed position to the deployed position releases the shuttle body and allows the spring to resume the unextended configuration. In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that when the actuator is in the undeployed position, the actuator abuts and locks against the shuttle body, and when the actuator is in the deployed position, the actuator does not contact and is disengaged from the shuttle body. In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator is configured to rotate relative to the shuttle body to transition between the undeployed and deployed positions.

[0038] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the housing includes a window formed thereon to enable visual feedback related to translation of the push rod.In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, and an exterior surface of the shuttle body includes a status indicator thereon for providing visual feedback through the window.

[0039] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing. A drag wire is attached to the shuttle body to control the delivery rate of the at least three implants. The injector further includes a shuttle reducer disposed within the housing, the shuttle reducer configured to receive the drag wire within its sinusoidal path. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the shuttle reducer's sinusoidal path is defined by a plurality of bosses, and interaction between the drag wire and the plurality of bosses creates friction that slows down the translation of the shuttle body and the push rod attached thereto. In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the drag wire is formed from stainless steel, and the plurality of bosses is formed from a plastic material.

[0040] In an aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is formed from stainless steel.

[0041] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the delivery rate of the at least three implants is controlled such that the delivery rate is between 3 and 10 seconds.

[0042] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the delivery rate of the at least three implants is controlled such that the delivery rate is between 4 and 9 seconds.

[0043] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a rotational damper disposed within the housing, the rotational damper coupled to the push rod and configured to slow down a rate at which the push rod moves within the housing.

[0044] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.035 inch-pounds, and the injector has an injection speed of 4 to 9 seconds.

[0045] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.4 pounds force (0.4 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 2.5 to 7.5 seconds.

[0046] In one aspect of the third embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 1.5 to 6.5 seconds.

[0047] According to a fourth embodiment herein, the present disclosure provides an injector including a housing including a window formed thereon, a push rod at least partially disposed within the housing, a magazine tube disposed within the housing, a cannula disposed outside the housing and having a distal end configured to be inserted into an eye, and an actuator. The magazine tube has an inlet, an outlet, and a lumen extending from the inlet to the outlet. The magazine tube is configured to slidably receive at least one implant therein, and the push rod is configured to be slidably received within the lumen of the magazine tube. Actuation of the actuator causes translation of the push rod through the magazine tube and the cannula. The window allows visual feedback of the translation of the push rod through the housing, and the visual feedback provides an indication that delivery of the at least one implant is complete.

[0048] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a gate disposed within the housing. The gate has a closed configuration that covers the outlet of the magazine tube and an open configuration that does not cover the outlet of the magazine tube. The lumen of the cannula is in fluid communication with the lumen of the magazine tube when the gate is in the open configuration. Actuation of the actuator moves the gate from the closed configuration to the open configuration. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the cannula and the magazine tube are coaxially aligned and a transition gap extends between the outlet of the magazine tube and the inlet of the cannula. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that a portion of the gate is disposed within the transition gap when the gate is in the closed configuration and a portion of the gate is not disposed within the transition gap when the gate is in the open configuration.

[0049] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a safety cap configured to be removably coupled to the housing to cover the distal end of the cannula when coupled to the housing, the safety cap including a tab that extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator.

[0050] In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the housing has a generally tubular structure having asymmetric fins that include a height that is greater than the height of the remaining length of the housing.

[0051] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the distal end of the cannula is beveled.

[0052] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body is coupled to a spring, the spring including an unextended configuration and an extended configuration, and is biased to the unextended configuration. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the spring is wound in the unextended configuration. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator in the undeployed position holds the shuttle body such that the spring is in the extended configuration. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that actuation of the actuator from the undeployed position to the deployed position releases the shuttle body and allows the spring to resume the unextended configuration. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that when the actuator is in the undeployed position, the actuator abuts and locks against the shuttle body, and when the actuator is in the deployed position, the actuator does not contact and is disengaged from the shuttle body. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the actuator is configured to rotate relative to the shuttle body to transition between the undeployed and deployed positions.

[0053] In an aspect of the fourth embodiment, in combination with any other aspect herein, the disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing. A drag wire is attached to the shuttle body. The injector further includes a shuttle reducer disposed within the housing, the shuttle reducer configured to receive the drag wire within its sinusoidal path. In an aspect of the fourth embodiment, in combination with any other aspect herein, the disclosure provides that the shuttle reducer's sinusoidal path is defined by a plurality of bosses, and interaction between the drag wire and the plurality of bosses creates friction that slows down translation of the shuttle body and the push rod attached thereto. In an aspect of the fourth embodiment, in combination with any other aspect herein, the disclosure provides that the drag wire is formed from stainless steel and the plurality of bosses is formed from a plastic material.

[0054] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is formed from stainless steel.

[0055] In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body slidably disposed within the housing, and an exterior surface of the shuttle body includes at least one status indicator thereon for providing visual feedback through a window. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one status indicator includes a first status indicator and a second status indicator. The first status indicator is disposed proximal to the second status indicator. The first status indicator is displayed through the window prior to actuation of the actuator, and the second status indicator is displayed through the window when delivery of the at least one implant is complete. In an aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one status indicator further includes a third status indicator disposed between the first status indicator and the second status indicator, and the second status indicator is disposed through the window while the shuttle body is moving within the housing. In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the first status indicator is a first color, the second status indicator is a second color, and the third status indicator is a third color.

[0056] In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the injector further includes a rotational damper disposed within the housing, the rotational damper coupled to the push rod and configured to slow down a rate at which the push rod moves within the housing.

[0057] In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.035 inch-pounds, and the injector has an injection speed of 4 to 9 seconds.

[0058] In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.4 pounds force (0.4 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 2.5 to 7.5 seconds.

[0059] In one aspect of the fourth embodiment, in combination with any other aspect herein, the present disclosure provides that the push rod is attached to a shuttle body that is slidably disposed within the housing, the shuttle body is coupled to a spring, the spring has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper has a damping torque of 0.026 inch-pounds, and the injector has an injection speed of 1.5 to 6.5 seconds.

[0060] According to a fifth embodiment herein, the present disclosure provides a method of delivering at least one implant to an eye using an injector. The distal tip of the injector is positioned adjacent to an injection site of the eye. The injector includes a push rod, a magazine tube having an inlet, an outlet, and a lumen extending from the inlet to the outlet, the magazine tube having at least one implant therein, a gate in a closed configuration covering the outlet of the magazine tube, a cannula, an actuator, and a status indicator. The distal end of the injector is passed to the eye tissue at the injection site. The actuator is actuated to deliver the at least one implant to the eye tissue. Actuation of the actuator moves the gate from a closed configuration to an open configuration in which the gate does not cover the outlet of the magazine tube, and actuation of the actuator also causes translation of the push rod through the magazine tube and the cannula to push the at least one implant. The position of the distal end of the injector is maintained within the eye tissue until a status indicator of the injector indicates completion of implant delivery. After the status indicator on the injector indicates completion of implant delivery, the injector is removed from the eye tissue.

[0061] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one implant includes exactly three implants.

[0062] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one implant is used to treat chronic non-infectious uveitis affecting the posterior segment of the eye of an eye in need of treatment.

[0063] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the ocular tissue comprises the vitreous of the eye.

[0064] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the implant is an intravitreal implant comprising about 0.18 mg of fluocinolone acetonide.

[0065] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the implant also includes polyvinyl alcohol, silicone adhesive, polyimide tubing, and may include water.

[0066] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the at least one implant is used to treat a retinal disease of an eye in need of treatment.

[0067] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema, and retinal vein occlusion.

[0068] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the implant is an intravitreal implant and comprises about 400 μg to about 2800 μg of borolanib.

[0069] In one aspect of the fifth embodiment, in combination with any other aspect herein, the present disclosure provides that the implant also includes polyvinyl alcohol. [Brief description of the drawings]

[0070] The foregoing and other features and advantages of the present invention will become apparent from the following description of embodiments herein, as illustrated in the accompanying drawings, which are incorporated in and form a part of this specification, and further serve to explain the principles of the invention and to enable those skilled in the art to make and use the invention. The drawings are not to scale.

[0071] [Figure 1]FIG. 2 is an exploded perspective view of a syringe according to one embodiment herein, the syringe being in an undeployed state and the safety cap not coupled to the syringe. [Diagram 2] 2 is an enlarged perspective view of a distal end portion of the syringe of FIG. 1, the syringe being in an undeployed state and the safety cap not being coupled to the syringe; [Diagram 3] 2 is a side view of the syringe of FIG. 1, the syringe in an undeployed state and a safety cap coupled to the syringe. [Figure 4] 2 is an enlarged perspective view of a distal end portion of the syringe of FIG. 1, the syringe in an undeployed state and a safety cap coupled to the syringe. [Diagram 5] FIG. 2 is a perspective view of the injector of FIG. 1, the injector in an undeployed state, with the injector housing removed for purposes of illustration. [Figure 5A] 5 along line AA in FIG. 5. [Figure 6] FIG. 2 is a perspective view of the injector of FIG. 1, the injector in a deployed state. [Figure 7] FIG. 2 is a perspective view of the injector of FIG. 1, the injector in a deployed state, with the injector housing removed for purposes of illustration. [Figure 7A] 7 along line AA in FIG. 7. [Figure 8A] 2 is a perspective view of the window chassis of the injector of FIG. 1, the window chassis being shown removed from the injector for illustrative purposes; FIG. [Figure 8B] FIG. 8B is a side view of the window chassis of FIG. 8A. [Figure 9] FIG. 2 is a perspective view of a magazine subassembly of the injector of FIG. 1, the magazine subassembly including a magazine tube, a magazine tube mount, a gate, a cannula, and a cannula mount, the magazine subassembly shown removed from the injector for illustrative purposes. [Figure 10] FIG. 10 is a perspective view of the cannula and cannula mount of FIG. [Figure 11]FIG. 10 is another perspective view of the cannula and cannula mount of FIG. 9, the cannula mount being shown in phantom. [Figure 12] FIG. 10 is a perspective view of the magazine tube, magazine tube mount, and gate of FIG. [Figure 13] FIG. 13 is an end view of FIG. [Figure 14] FIG. 14 is an end view of FIG. 13 with the gate removed for illustration purposes. [Figure 15] FIG. 13 is a perspective view of the magazine tube of FIG. 12, the magazine tube shown in phantom and shown holding three implants. [Figure 16A] FIG. 10 is an enlarged cross-sectional view of the magazine subassembly of FIG. 9 when the gate is in a closed configuration. [Figure 16B] FIG. 10 is an enlarged cross-sectional view of the magazine subassembly of FIG. 9 when the gate is in an open configuration. [Figure 17] FIG. 10 is a perspective view of a gate of the magazine subassembly of FIG. [Figure 18] FIG. 2 is a perspective view of a shuttle subassembly of the injector of FIG. 1, the shuttle subassembly including a shuttle body, a push rod, a spring, and a drag wire, the shuttle subassembly being shown removed from the injector for illustrative purposes. [Figure 18A] 18 along line AA in FIG. 18. FIG. [Figure 19] FIG. 20 is a perspective view of a spring of the shuttle subassembly of FIG. 18. [Figure 20] 2 is an enlarged perspective view of the actuator of the injector of FIG. 1 when the injector is in an undeployed state. FIG. [Figure 21] 2 is an enlarged side view of the actuator of the injector of FIG. 1 when the injector is in an undeployed state. FIG. [Figure 22] 2 is an enlarged side view of the actuator of the injector of FIG. 1 when the injector is in a deployed state. FIG. [Figure 23]8B is a perspective view of the window chassis of FIG. 8A attached to an actuator chassis of the injector, the window chassis and actuator chassis being shown removed from the injector for illustrative purposes. [Figure 24] 24 is a perspective view of the magazine assembly of FIG. 9 coupled to the window chassis and actuator chassis of FIG. 23, the magazine assembly, window chassis and actuator chassis being shown removed from the injector for purposes of illustration. [Diagram 25] FIG. 24 is a perspective view of a push rod coupled to the window chassis and actuator chassis of FIG. 23, the push rod, window chassis and actuator chassis shown removed from the injector for illustrative purposes. [Figure 26A] FIG. 24 is a perspective view of the actuator chassis and actuator of the injector of FIG. 23, the actuator chassis and actuator being shown removed from the injector for illustrative purposes, and the actuator being in a non-deployed state. [Figure 26B] FIG. 24 is a perspective view of the actuator chassis and actuator of the injector of FIG. 23, the actuator chassis and actuator being shown removed from the injector for illustrative purposes, and the actuator being in a deployed state. [Figure 27] FIG. 24 is a perspective view of the actuator chassis of FIG. 23. [Figure 28] 24 is a perspective view of the actuator chassis of FIG. 23 and an actuator disposed therein when the injector is in a non-deployed state. [Figure 29] 24 is a perspective view of the actuator chassis of FIG. 23 and an actuator disposed therein when the injector is in a deployed state. FIG. [Figure 30A] FIG. 2 is a perspective view of the actuator and magazine subassembly of the injector of FIG. 1, illustrating the relative positioning of the actuator and gate when the injector is in a non-deployed state. [Figure 30B]FIG. 13 is an enlarged cross-sectional view illustrating the relative positioning of the actuator and gate when the injector is in a non-deployed state. [Diagram 31] FIG. 13 is an enlarged cross-sectional view illustrating the relative positioning of the actuator and gate when the injector is in a deployed state. [Diagram 32] FIG. 13 is an enlarged cross-sectional view illustrating the relative positioning of the actuator and shuttle subassembly when the injector is in a non-deployed state. [Diagram 33] FIG. 13 is an enlarged cross-sectional view illustrating the relative positioning of the actuator and shuttle subassembly when the injector is in a deployed state. [Diagram 34] FIG. 2 is an enlarged perspective view of the injector of FIG. 1 with the housing and window chassis removed from the injector for illustrative purposes, the injector shown in an unfolded state, and the shuttle subassembly shown in perspective. [Diagram 35] 2 is an enlarged cross-sectional view of a shuttle subassembly of the injector of FIG. 1, the injector further including a shuttle reducer. [Diagram 36] FIG. 36 is a perspective view of the shuttle reducer of FIG. 35, the shuttle reducer shown removed from the injector for illustrative purposes. [Figure 37] FIG. 13 is an enlarged perspective view of the drag wire of the shuttle subassembly disposed through the shuttle reducer. [Figure 38] 1 is a perspective view of an injector according to another embodiment herein, the injector including a rotational damper; [Figure 39] FIG. 40 is a perspective view of the shuttle subassembly of the injector of FIG. 38, the shuttle subassembly being shown removed from the injector for illustrative purposes. [Diagram 40] 1 is a method of using an injector according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] Specific embodiments of the present invention are described with reference to the Figures, in which like reference numbers indicate identical or functionally similar elements. The following Detailed Description is merely exemplary in nature and is not intended to limit the invention, or the application and uses of the invention. Although the present invention has been described primarily in the context of delivering an implant to ocular tissue, the present invention may also be used to deliver other implants that are deemed useful. The term "injector" is intended broadly to include all types of dispensing devices, and the presently disclosed injectors are not limited to medical applications. In addition, the term "injector" may be used interchangeably herein with the term "applicator," and the term "inject" may be used interchangeably herein with the term "insert." Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following Detailed Description.

[0073] In this disclosure, the term "proximal" is used to refer to the portion of an element closest to the physician using the device to inject the implant at the injection site. The term "distal" is used herein to refer to the portion of an element furthest from the physician's hand and closest to the injection site when an injector is utilized to inject the implant. Additionally, as used herein, the terms "a" or "an" are used to refer to one or more. For example, "an implant" is used herein to refer to one or more implants. Additionally, the term "implant" may be used interchangeably herein with the term "insert."

[0074] In one embodiment, the injector of the present disclosure is configured for intraocular drug delivery and is used to deliver one or more implants or payloads to the eye. In one embodiment, the injector is configured to deliver multiple implants to the posterior portion of the human eye. The implant may include a therapeutically effective amount of one or more drugs, and may be, for example, any solid composition for releasing a drug or other agent. Such devices can typically be implanted in any number of locations within tissue and can be designed to release a controlled amount of a desired drug or therapeutic over time. In certain embodiments, the implant includes a therapeutic agent and a polymer. The therapeutic agent may include a steroid or a biologic. For example, the therapeutic agent may include bevacizumab or ranibizumab. In a preferred embodiment, the therapeutic agent includes a corticosteroid, such as fluocinolone acetonide. In some embodiments, the longitudinal length of the implant is 0.1 to 0.6 centimeters. The implant has a cross-sectional diameter of 0.66 mm or less, since it can be delivered through the cannula of the injector that is compatible with a cannula of 21 gauge or less. The injector may be used to position the implant at a desired implantation site, for example, in the vitreous cavity of the eye. For such an embodiment, as described in more detail herein, the injector may be positioned near the eye and the injector's cannula may be positioned through the sclera into the vitreous of the eye to place the implant. Once the implant is delivered to the eye, the cannula may be withdrawn. Applying the implant may include injecting the implant into the patient's eye, for example, inserting the implant into the posterior, anterior or posterior chamber of the eye, or other regions of the eye, including intraretinal, intravitreal, subretinal, intrachoroidal, suprachoroidal, intrascleral, episcleral, subconjunctival, intercorneal or epicorneal spaces. For example, the implant may be injected into the aqueous humor or, preferably, into the vitreous humor of the eye (intravitreous).

[0075] In one aspect of the first embodiment, in combination with any other aspect herein, the present disclosure provides a method of preventing or treating an ocular condition or disease of an eye in need of prevention or treatment, comprising administering an implant containing an active pharmaceutical ingredient (API) using an injector of the first embodiment. In some embodiments, the implant is administered to treat a pre-ocular condition. In other embodiments, it may be administered to treat a posterior ocular condition. In some embodiments, the implant is administered to prevent a pre-ocular condition. In other embodiments, it may be administered to prevent a posterior ocular condition.

[0076] An "anterior ocular condition" is a disease, illness, or condition that affects or involves anterior (i.e., the front of the eye, also called the anterior segment) ocular segments or structures, such as the periocular muscles or eyelids, or the fluid located in front of the lens capsule or the posterior wall of the ciliary muscles. Thus, an anterior ocular condition may affect or involve the conjunctiva, cornea, anterior chamber, iris, posterior chamber (located between the iris and the lens), lens or lens capsule, and blood vessels and nerves that vascularize or innervate anterior segments or regions.

[0077] An ocular condition can include, but is not limited to, a disease, illness or condition such as glaucoma.

[0078] A "posterior ocular condition" is a disease, illness, or condition that primarily affects or involves posterior (i.e., back surface of the eye, also called the posterior segment) ocular segments or structures, such as the choroid or sclera (which lie posterior to a plane passing through the posterior wall of the lens capsule), vitreous body, vitreous cavity, retina, optic nerve or optic nerve head, and the blood vessels and nerves that vascularize or innervate the posterior segment or area.

[0079] Posterior ocular conditions include acute macular neuroretinopathy, Behcet's disease, geographic atrophy, choroidal neovascularization, diabetic uveitis, histoplasmosis, infections such as infections caused by fungi, bacteria, or viruses, macular degeneration such as neovascular macular degeneration, acute macular degeneration, non-exudative age-related macular degeneration and exudative age-related macular degeneration, edema such as macular edema, cystoid macular edema, and diabetic macular edema, multifocal choroiditis, ocular trauma affecting a posterior ocular site or location, ocular tumors, retinal vein occlusion, central retinal vein occlusion, diabetic retinopathy (including proliferative diabetic retinopathy), proliferative vitreous retinopathy (PVR), hypertensive retinopathy These diseases, conditions or conditions include, but are not limited to, retinal artery occlusion diseases such as central retinal artery occlusion (CRAO) and branch retinal artery occlusion (BRAO), retinal diseases such as retinal detachment, uveitis retinal disease, sympathetic ophthalmia, Vogt-Koyanagi-Harada (VKH) syndrome, uveal diffusion, posterior ocular conditions caused or affected by ocular laser treatment or posterior ocular conditions caused or affected by photodynamic therapy, photocoagulation, radioretinal therapy, epiretinal membrane disorder, branch retinal vein occlusion, anterior ischemic optic neuropathy, non-retinopathy diabetic retinal dysfunction, and retinitis pigmentosa. Glaucoma may also be considered a posterior ocular condition, since the goal of treatment is to prevent or reduce the onset of blindness due to damage or loss of retinal cells or optic nerve cells (e.g., via neuroprotection).

[0080] In certain embodiments, the implant is administered to prevent or treat macular degeneration in an eye in need of prevention or treatment, for example, age-related macular degeneration ("AMD"), such as dry AMD and wet AMD. The implant may be administered to prevent retinal pigment epithelial cell death. The implant may be administered to inhibit angiogenesis. In some embodiments, the implant is administered to prevent or treat vision loss in an eye, such as vision loss associated with macular degeneration. Additionally, the implant may be administered to prevent or slow the progression of dry AMD to wet AMD. In some embodiments, the implant is administered to prevent or treat retinal vein occlusion in an eye in need of prevention or treatment, for example, central retinal vein occlusion ("CRVO") or branch retinal vein occlusion ("BRVO"). In other embodiments, the implant may be administered to prevent or treat non-ischemic retinal vein occlusion or ischemic retinal vein occlusion. In yet other embodiments, the implant is administered to treat diabetic retinopathy in an eye in need of treatment.

[0081] The API within the implant administered to a particular ocular condition or disease is selected based on the suitability of the API for that ocular condition.

[0082] The implants of the present invention may be used to deliver various classes of APIs. Examples of these classes of APIs and specific APIs include:

[0083] In some embodiments, the API is a kinase inhibitor, such as a vascular endothelial growth factor (VEGF) inhibitor (sometimes referred to as anti-VEGF), a tyrosine kinase (TKI) inhibitor, a vascular endothelial protein tyrosine phosphatase (VE-PTP) inhibitor, an Ang-1 inhibitor, an Ang-2 inhibitor, a Tie-2 activator, a Tie-2 agonist, or an mTOR inhibitor. APIs with one or more of these activities include altiratinib, revastinib, afatinib, alectinib, apatinib, ASP-3026, axitinib, bafetinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, canertinib, cediranib, CEP-11981, CEP-37440, ceritinib, cobimetinib, copanrifin ... Sib, crenolanib, crizotinib, CYT387, dabrafenib, damnacanthal, dasatinib, dramapimod, entrectinib, erlotinib, everolimus, filgotinib, foretinib, fostamatinib, gefitinib, grandinin, ibrutinib, icotinib, idelalisib, imatinib, IPI-145, JSI-124, lapatinib, lenva Tinib, lestaurtinib, linifanib, masitinib, motesanib, mubritinib, neratinib, nilotinib, nintedanib, pacritinib, palbociclib, pazopanib, pegaptanib, perifosine, pexmetinib, PF-06463922, ponatinib, PX-866, quizartinib, radotinib, razuprotafib (AKB-9778), regorafenib, leuproxine ... These include xolitinib, selumetinib, semaxanib, sirolimus, sorafenib, sorafenib tosylate, staurosporine, sunitinib, sunitinib malate, SU6656, temsirolimus, TG101348, tivozanib, toceranib, tofacitinib, trametinib, TSR-011, vandetanib, vatalanib, vemurafenib, borolanib, and X-396.

[0084] In some embodiments, the API may be a steroidal anti-inflammatory agent, such as a steroid or a corticosteroid, non-limiting examples of which are fluocinolone acetonide, hydrocortisone, hydrocortisone acetate, triamcinolone acetonide, methylprednisolone, dexamethasone, medrysone, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, and betamethasone.

[0085] In other embodiments, the API is a prostaglandin or a prostaglandin analog or agonist, such as bimatoprost, latanoprost, latanoprost bunod, tafluprost, or travoprost.

[0086] In yet other embodiments, the API is an alpha-2 adrenergic receptor agonist, such as brimonidine, brimonidine tartrate, or brimonidine pamoate.

[0087] In some embodiments, the API is a beta blocker, such as timolol.

[0088] In other embodiments, the API is a carbonic anhydrase inhibitor (CAI), such as acetazolamide, brinzolamide, dorzolamide, or methazolamide.

[0089] In other embodiments, the API is a rho khinase inhibitor, such as netarsudil.

[0090] Nonsteroidal anti-inflammatory drugs (NSAIDs) are also contemplated.NSAIDs include diclofenac, etoldolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indoprofen, ketoprofen, ketorolac, lomoxicam, morazon, naproxen, perisoxal, pirprofen, pranoprofen, suprofen, suxibuzone, tropesin, xymoprofen, zaltoprofen, zileuton, and zomepirac.COX-2 inhibitors such as valdecoxib, rofecoxib, and celecoxib are also contemplated.

[0091] In some embodiments, the API is a neuroprotectant such as nimodipine, an antibiotic such as tetracycline, chlortetracycline, bacitracin, neomycin, polyrnyxin, gramicidin, oxytetracycline, chloramphenicol, gentamicin, or erythromycin, or an antibacterial agent such as a sulfonamide, sulfacetamide, sulfamethizole, sulfisoxazole, nitrofurazone, or sodium propionate.

[0092] In another embodiment, the API is a compliment inhibitor, such as a C3 inhibitor, e.g., APL-2 (pegcetacoplan), or a C5 inhibitor.

[0093] Anesthetics and analgesics such as lidocaine and related compounds are also contemplated.

[0094] In some embodiments, the implant comprises two or more APIs.

[0095] Additionally, the present invention contemplates the use of analogs, derivatives, pharma- ceutically acceptable salts, esters, prodrugs, co-drugs, and protected forms thereof of the API.

[0096] The term "pharmaceutically acceptable salt" of a given compound refers to salts that retain the biological effectiveness and properties of the given compound and which are not biologically or otherwise undesirable.

[0097] In some embodiments of the method, the implant comprises a VEGF inhibitor, a kinase inhibitor such as a TKI inhibitor, a VE-PTP inhibitor, an Ang-1 inhibitor, an Ang-2 inhibitor, and / or a Tie-2 activator. In some embodiments, the implant comprises borolanib, or a pharmaceutically acceptable salt thereof. In other embodiments, the implant comprises axitinib, or a pharmaceutically acceptable salt thereof. In yet other embodiments, the implant comprises razuprotafib, or a pharmaceutically acceptable salt or zwitterion thereof.

[0098] In other embodiments, an implant is administered to activate Tie-2. In some embodiments of the method, the implant comprises a Tie-2 activator. In further embodiments, the Tie-2 activator is razuprotafib, or a pharma- ceutically acceptable salt or zwitterion thereof.

[0099] In some embodiments, the implant is administered to treat uveitis. In further embodiments, the implant is administered to treat chronic non-infectious uveitis affecting the posterior segment of the eye. In some embodiments, the implant is administered to treat post-operative inflammation of the eye. In some embodiments of these methods, the implant comprises a steroidal anti-inflammatory agent. In one embodiment, the implant comprises a corticosteroid and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The corticosteroid may be a synthetic corticosteroid, such as, but not limited to, fluocinolone acetonide. The chemical name for fluocinolone acetonide is (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-pregna-1,4-diene-3,20-dione. The implant may be a sterile, non-bioerodible intravitreal implant containing 0.18 mg of fluocinolone acetonide in a 36-month sustained release drug delivery system. In one embodiment, the implant comprises 0.18 mg of the active ingredient fluocinolone acetonide and the following inactive ingredients: polyimide tubing, polyvinyl alcohol, silicone adhesive, and water for injection. The implant may be configured to release fluocinolone acetonide at an initial rate of 0.25 mcg / day. In one embodiment, each implant may be approximately 3.5 mm (length) by 0.37 mm (width).

[0100] In some embodiments, the implant comprises a VEGF inhibitor, hi some embodiments, the VEGF inhibitor is borolanib, or a pharma- ceutically acceptable salt thereof.

[0101] In one embodiment, the implant is an intravitreal implant comprising about 100 μg to about 2800 μg, about 400 μg to about 2800 μg, or about 400 μg to about 2000 μg of borolanib. The implant may also include a polymer, such as polyvinyl alcohol. In one embodiment, each implant is about 3 mm to about 10 mm in length. In one embodiment, each implant is about 6 mm to about 9 mm in length.

[0102] In one embodiment, the implant is configured to be implanted in other parts of the eye beyond the vitreous cavity of the eye. In one embodiment, the injector of the present disclosure is used to deliver one or more implants to the eye for the treatment of chronic non-infectious uveitis affecting the posterior portion of the eye. In some embodiments, the injector is used to deliver one or more implants to the eye for the treatment or prevention of retinal disease. In some embodiments, the retinal disease is selected from wet AMD, diabetic retinopathy, diabetic macular edema, and retinal vein occlusion.

[0103] The implant may be configured for the treatment of patients with active or suspected ocular or periocular infections, including most viral diseases of the cornea and conjunctiva.

[0104] Turning now to the figures, an injector 100 according to the present disclosure will be described in more detail. FIGS. 1-5 show the injector 100 in an undeployed state with one or more implants contained within the injector, and FIGS. 6-7A show the injector 100 in a deployed state after one or more implants have been delivered to the eye. The injector 100 includes a housing 102 and a safety cap 104 removably coupled to the housing 102. FIG. 5 is a perspective view of the injector 100 in an undeployed state with the housing 102 removed for illustrative purposes to show the internal components of the injector, and FIG. 5A is a cross-sectional view taken along line AA of FIG. 5. Similarly, FIG. 7 is a perspective view of the injector 100 in an undeployed state with the housing 102 removed for illustrative purposes to show the internal components of the injector, and FIG. 7A is a cross-sectional view taken along line AA of FIG. 7.

[0105] The injector 100 includes a magazine subassembly 130, a shuttle subassembly, and an actuator 170. The magazine subassembly 130 includes a cannula 122, a magazine tube 132, and a gate 140, and the shuttle subassembly 150 includes a push rod 160. The magazine tube 132, the gate 140, and the shuttle subassembly 150 are disposed within the housing 102. The cannula 122 is partially disposed within the housing 102, with a distal portion thereof extending distally from a distal end of the housing 102. More specifically, the cannula 122 has a distal end 123 that is not disposed within the housing 102 and is configured to be inserted into an eye. The distal end 123 of the cannula 122 defines an outlet for the cannula 122. An actuator 170 is also partially disposed within the housing 102 and is readily accessible to a user for manipulating the injector 100 from the undeployed condition of FIGS. 1-5 to the deployed condition of FIGS. 6-7A.

[0106] As described in more detail herein, the magazine tube 132 of the magazine subassembly 130 is configured to slidably receive or accommodate at least one implant therein, and the push rod 160 is configured to be slidably received within the magazine tube 132 and the cannula 122. The gate 140 of the magazine subassembly 130 has a closed configuration that covers or blocks the outlet of the magazine tube 132 and an open configuration that does not cover the outlet of the magazine tube 132 such that the outlet of the magazine tube 132 is exposed. When the gate 140 is in the open configuration, the cannula 122 is in fluid communication with the magazine tube 132. Actuation of the actuator 170 from the undeployed position to the deployed position moves or displaces the gate 140 from the closed configuration to the open configuration. Actuation of the actuator 170 also results in or causes movement or translation of the push rod 160 into and through the magazine tube 132 and the cannula 122 to deliver at least one implant contained within the magazine tube 132 through the cannula 122 to the eye.

[0107] The housing 102 and safety cap 104 of the injector 100 are described in more detail with reference to Figures 1-4. Figures 1 and 2 show the safety cap 104 uncoupled from the injector housing 102, and Figure 2 is an enlarged perspective view of a distal end portion of the injector 100. The housing 102 includes a proximal end 101 and a distal end 103. The housing 102 is generally tubular or cylindrical. In one embodiment, the outer diameter of the housing 102 ranges from 15 mm to 18 mm. The housing 102 is configured and sized such that the injector 100 may be operated with only one hand in a typical clinical environment. The housing 102 may include an asymmetric fin 106 near its distal end 103, which is not cylindrical. The asymmetric fin 106 has a relatively enlarged height or depth that is greater than the height or depth of the remaining length of the housing 102, which is cylindrical. For example, in one embodiment, the height or depth of the asymmetric fin 106 is up to twice the height or depth of the remaining length of the housing 102. The width of the housing 102 is consistent along the entire length of the housing 102 regardless of whether the asymmetric fin 106 is present. As such, in one embodiment, the width of the asymmetric fin 106 is equal to the width of the remaining length of the housing 102, which is cylindrical. The asymmetric fin 106 may extend 20-40% of the entire length of the housing 102. The asymmetric fin 106 includes a finger gripping surface 107 thereon. Although FIGS. 1 and 2 show only one side of the injector 100, a similar finger gripping surface is preferably included on the asymmetric fin 106 on the opposite side of the housing 102. The shape and texture of the asymmetric fin 106 are configured to allow a user to easily hold and grip the injector 100 and improve stability of the injector 100 during operation. Each finger gripping surface 107 may be formed from an elastomeric material and may include a plurality of ribs formed thereon. Any of a variety of shapes or configurations may be selected for the finger gripping surfaces 107 to provide suitable finger placement during operation of the injector.

[0108] The housing 102 further includes a window 108 formed thereon. As described in more detail herein, the window 108 allows for visual feedback related to the movement or translation of the shuttle subassembly 150 within the housing 102. Stated another way, a user may view the movement of the shuttle subassembly 150 during operation of the injector 100. As described in more detail herein, the shuttle subassembly 150 may include one or more status indicators on its exterior surface to alert a user to the relative positioning of the shuttle subassembly 150 within the housing 102. For example, the status indicators may include notations, symbols, indications, colors, and the like. Prior to deployment or actuation of the actuator 170, for example, a first color or status indicator may be displayed to a user via the window 108 of the housing 102. The shuttle subassembly 150 moves relative to the housing 102 during operation of the injector 100, and thus a second color or status indicator may be displayed to the user through the window 108 in the housing 102 after deployment, providing visual feedback to the user that the deployment operation is complete.

[0109] The housing 102 also includes an opening 109 formed therein. An actuator 170 extends through the opening 109 for ease of access by a user. When in the undeployed position, as shown in FIGS. 1-4, the actuator 170 projects outwardly from the housing 102 for ease of use by a user. The actuator 170 may include a finger gripping surface 105 thereon. The finger gripping surface 105 may be formed from an elastomeric material and may include a plurality of ribs formed thereon. Any of a variety of shapes or configurations may be selected for the finger gripping surface 105 to provide suitable finger placement during operation of the injector.

[0110] 3 and 4 show the safety cap 104 coupled to the housing 102 of the injector, with FIG. 4 being an enlarged perspective view of a distal end portion of the injector 100. The safety cap 104 is configured to be removably coupled to the housing 102. The safety cap 104 is configured to cover the distal end 123 of the cannula 122 when the injector 100 is not in use and to prevent actuation of the actuator 170 when the safety cap 104 is coupled to the housing 102 to prevent inadvertent actuation of the injector 100. More specifically, as shown in FIGS. 3 and 4, when coupled to the housing 102, the safety cap 104 covers and protects the distal end portion of the injector 100, including the distal end 123 of the cannula 122 that is not disposed within the housing 102. The safety cap 104 has a proximal end 110 configured to couple to the distal end 103 of the housing 102. The safety cap 104 has a generally conical configuration that tapers from the proximal end 110 to the distal tip 112. The safety cap 104 further includes a finger gripping surface 115 thereon. Although FIGS. 3 and 4 show only one side of the safety cap 104, a similar finger gripping surface is preferably included on the opposite side of the safety cap 104 to allow a user to easily hold and grip the safety cap 104 during removal. Each finger gripping surface 115 may be formed from an elastomeric material and may include a number of ribs formed thereon. Any of a variety of shapes or configurations may be selected for the finger gripping surfaces 115 to provide suitable finger placement during operation of the syringe.

[0111] The proximal end 110 of the safety cap 104 includes a pair of opposed tabs 114A, 114B. When the safety cap 104 is coupled to the housing 102, the tab 114A extends into a slot or opening 116 formed through the actuator 170 to prevent inadvertent actuation of the actuator 170. Stated another way, when the tab 114A is disposed in the slot 116, the actuator 170 cannot be depressed or actuated by a user. Thus, the actuator 170 is configured to interface with the safety cap 104 such that the injector 100 cannot be operated when the safety cap 104 is coupled to the housing 102. When the safety cap 104 is coupled to the housing 102, the tab 114B extends into a slot or opening 118 formed through the asymmetric fin 106 of the housing 102 to further secure the safety cap 104 to the housing 102.

[0112] 8A and 8B are perspective and side views, respectively, of the window chassis 119 of the injector 100, with the window chassis 119 shown removed from the injector 100 for illustrative purposes. The window chassis 119 is a transparent component formed from a relatively rigid material, such as polycarbonate or acrylic. The window chassis 119 is fixed or retained in the housing 102 and does not move relative to the housing 102. In another embodiment herein (not shown), features or functions of the window chassis 119 may be incorporated or built into the housing 102 such that the window chassis 119 may be eliminated. The window chassis 119 includes a proximal end 113A and a distal end 113B. At the proximal end 113A, the window chassis 119 includes a semicircular portion 162. When the chassis 119 is retained within the housing 102, the window 108 of the housing 102 is disposed over the semicircular portion 162 of the window chassis 119. The window chassis 119 is formed from a transparent material, thereby allowing visualization of the shuttle subassembly 150 during operation of the injector 100, as described above.

[0113] The window chassis 119 is configured to receive the magazine subassembly 130 therein. At the distal end 113B, the window chassis 119 includes an annular ring portion 169. Proximal to the distal end 113B, the window chassis 119 includes a pair of integral shelves 168A, 168B formed on an inner surface of the window chassis for receiving corresponding features of the magazine subassembly 150 (prongs 129A, 129B, described in more detail herein) to secure the magazine subassembly 150 to the window chassis 119.

[0114] The window chassis 119 is also configured to slidably receive the shuttle subassembly 150 therein. Stated otherwise, the shuttle subassembly 150 slides or moves relative to the window chassis 119 during operation of the injector 100. The window chassis 119 includes a pair of opposing rails 167A, 167B. The shuttle subassembly 150 slides or moves within the window chassis 119 along the rails 167A, 167B during operation of the injector 100. Additionally, near the distal end 113B, the window chassis 119 further includes a hook 111 formed on an outer surface thereof. A spring 156 of the shuttle assembly 150 is attached to the hook 111 as will be described in more detail below.

[0115] The window chassis 119 is also configured to be secured to an actuator chassis 172 that receives and interacts with an actuator 170, as described in more detail herein. More specifically, the window chassis 119 includes a pair of openings or slots 166A, 166B for receiving corresponding tabs 141A, 141B of the actuator chassis 172 in a snap-fit ​​arrangement to secure the actuator chassis 172 to the window chassis 119.

[0116] With reference to Figures 9-17, the magazine subassembly 130 of the injector 100 will be described in more detail. Figure 9 is a perspective view of the magazine subassembly 130 of the injector 100. In addition to the cannula 122, the magazine tube 132, and the gate 140, the magazine subassembly 130 also includes a cannula mount 120 and a magazine tube mount 134. The cannula 122 is securely attached to and disposed within the cannula mount 120, and the magazine tube 132 is securely attached to and disposed within the magazine tube mount 134. The cannula mount 120 is secured to the magazine tube mount 134 via a snap-fit ​​attachment, as shown in Figure 9. In the configuration of Figure 9, the magazine subassembly 130 may be the last component to be inserted or slid into the housing 102 of the injector 100 for final assembly thereof. When inserted into the housing 102, the proximal end of the magazine subassembly 130 (including prongs 129A, 129B, described in more detail herein) is configured to snap into integral shelves 168A, 168B of the window chassis 119. Once retained in the window chassis 119, the magazine subassembly 130 is fixed with respect to the housing 102 and with respect to the window chassis 119 and does not move relative thereto.

[0117] FIGURE 10 is a perspective view of the cannula mount 120 and the cannula 122 secured thereto, and FIGURE 11 is a similar view showing the cannula mount in perspective for illustrative purposes. The cannula mount 120 includes a pair of opposing prongs 124A, 124B at a proximal end for coupling the cannula mount 120 to a magazine tube mount 134 via a snap-fit ​​attachment. The cannula mount 120 also includes a conical portion 126 and a tubular portion 128 at a distal end. The conical portion 126 and the tubular portion 128 include a continuous lumen 125 therethrough for receiving the cannula 122. When assembled into the injector 100, the conical portion 126 of the cannula mount 120 abuts the distal end 103 of the housing 102. A tubular portion 128 of cannula mount 120 extends distally from conical portion 126 and supports the portion of cannula 122 that extends outside of housing 102 .

[0118] Cannula 122 is secured or retained within a continuous lumen 125 of cannula mount 120 to prevent movement of cannula 122 relative to cannula mount 120. Cannula 122 has a lumen 127 that extends its entire length from a proximal or inlet end 121 to a distal end 123, which may also be considered an outlet of cannula 122. Lumen 127 is sized or configured to slidably receive push rod 160 therethrough. As best shown in FIG. 11 , proximal end 121 of cannula 122 may have a flared configuration having a larger outer diameter than the remaining length of cannula 122 to further prevent withdrawal or any distal movement of cannula 122 within cannula mount 120 as push rod 160 passes therethrough. When assembled into the injector 100 , the proximal end 121 of the cannula 122 is disposed within the housing 102 .

[0119] The distal end 123 of the cannula 122 is beveled and configured for insertion into the eye. In one embodiment, the bevel of the distal end 123 is oriented upwardly such that the bevel of the distal end 123 is aligned with the actuator 170 of the injector. As best shown in FIG. 10 , the distal end 123 extends distally beyond the distal end of the tubular portion 128 of the cannula mount 120 such that the distal end 123 is exposed for insertion into the eye.

[0120] The cannula 122 may be formed from 18-30 gauge tubing adapted to penetrate the sclera of the eye. The cannula 122 preferably has a straight longitudinal profile, although other suitable longitudinal needle shapes may be used. The bevel at the distal end 123 may be disposed at an angle of about 10 degrees to 13 degrees, preferably about 11.5 degrees, relative to the longitudinal axis of the cannula 122. The cannula 122 may be made from any suitably rigid material, such as a metal or metal alloy (e.g., stainless steel), or a polymeric material, such as polyimide, silicone, polycarbonate, and / or polyvinyl carbonate. The cannula 122 may have an outer diameter of 0.25 mm to 1.0 mm.

[0121] 12-13 show perspective and end views of magazine tube 132, magazine tube mount 134, and gate 140. Additionally, FIG. 14 is the same end view as FIG. 13, except that gate 140 has been removed for illustrative purposes. Magazine tube mount 134 includes a proximal end 143 and a distal end 145. Distal end 145 of magazine tube mount 134 includes two opposing semicircular tabs 136A, 136B. As best shown in FIG. 9, a pair of opposing prongs 124A, 124B of cannula mount 120 grip or hook onto semicircular tabs 136A, 136B of magazine tube mount 134 in a snap-fit ​​arrangement to attach cannula mount 120 to magazine tube mount 134. The magazine tube mount 134 includes a pair of opposing prongs 129A, 129B for coupling the magazine tube mount 134 to the window chassis 119 via a snap fit arrangement. The magazine tube mount 134 includes a continuous lumen 135 for receiving the magazine tube 132 therethrough.

[0122] The magazine tube 132 is secured or held within a lumen 135 of the magazine tube mount 134 to prevent movement of the magazine tube 132 relative to the magazine tube mount 134. The magazine tube 132 has a lumen 137 that extends its entire length from a proximal end or inlet 131 to a distal end or outlet 133. The lumen 137 is sized or configured to slidably receive a push rod 160 therethrough. Additionally, as best shown in FIG. 15, which is a perspective view of the magazine tube 132 removed from the magazine tube mount 134 and shown in phantom for illustrative purposes, the magazine tube 132 is sized and configured to hold or maintain up to three implants 138 in a serial arrangement when the injector 100 is in a non-deployed state. Stated another way, prior to operation of the injector 100, the implants 138 reside within the lumen 137 of the magazine tube 132. The injector 100 is configured to deliver three implants 138 sequentially to the eye via a single actuation of the actuator 170.

[0123] In one embodiment, the implants 138 may be preloaded into the magazine subassembly 130 by a pharmaceutical manufacturer. More specifically, the implants 138 may be preloaded into the magazine tube 132 of the magazine subassembly 130 prior to assembly of the injector, and the pharmaceutical manufacturer may store and / or ship the magazine subassembly 130 preloaded with the implants 138. After shipping, the magazine subassembly 130 with the implants 138 preloaded therein may be inserted into the housing 102 for final assembly of the injector 100 prior to use. As such, the magazine subassembly 130 may be considered a disposable, sterilizable cartridge that may be manufactured and shipped separately from the remaining components of the injector 100. During shipping, the inlet 131 of the magazine tube 132 may be blocked for shipping, and the outlet 133 of the magazine tube 132 may be blocked or closed via a gate 140, as described in more detail herein.

[0124] 16A, which is an enlarged cross-sectional view of the magazine subassembly 130 when the injector 100 is in a non-deployed state and the gate 140 is in a closed configuration, the cannula 122 and the magazine tube 132 are coaxially aligned. In particular, the magazine subassembly 130 is concentrically located within the window chassis 119 when secured therein. At the distal end 145, the magazine mount 134 includes a plurality of radially extending ribs 147 for limiting or restricting movement of the magazine subassembly 130 within the window chassis 119. When assembled to the window chassis 119, as shown in FIG. 16A, the plurality of radially extending ribs 147 are disposed within annular ring portion 169 at the distal end 113B of the window chassis 119.

[0125] 16A , a distal end or outlet 133 of magazine tube 132 is spaced from a proximal end or inlet 121 of cannula 122 by a transition gap 139. As shown in FIG. 16A , when gate 140 is disposed within transition gap 139, gate 140 covers or blocks distal end or outlet 133 of magazine tube 132. Stated another way, when gate 140 is disposed within transition gap 139, gate 140 does not allow lumen 137 of magazine tube 132 to be in fluid communication with lumen 127 of cannula 122.

[0126] FIG. 17 is a perspective view of the gate 140 removed from the magazine tube mount 134. The gate 140 is a generally planar component formed from sheet metal, including a proximal end 142, a distal end 144, and a pair of lateral wings 146A, 146B. In one embodiment, the thickness along the length of the gate 140 may vary such that the portion of the gate 140 that flexes or deflects during operation of the injector 100 is relatively thin or tapered to minimize the force required for movement. The proximal end 142 of the gate 140 is held and secured to the proximal end 143 of the magazine tube mount 134, as shown in FIG. 12. The remaining length of the gate 140 is not secured to the magazine and may be displaced therefrom. The gate 140 includes an integral bend 148 that is approximately 90 degrees such that the distal end 144 extends along a perpendicular plane relative to the remaining length of the gate 140 during operation of the injector 100. When the injector 100 is in the undeployed state, the majority of the gate 140 abuts or extends along the underside of the magazine tube mount 134, except for a distal end 144 of the gate 140 that extends over the distal end or outlet 133 of the magazine tube 132, as best shown in FIG. 12, 13 or 16A. The gate 140 may be considered to be in a closed configuration when its distal end 144 covers or extends over the distal end or outlet 133 of the magazine tube 132. Because the distal end 144 of the gate 140 is disposed between the magazine tube 132 and the cannula 122 within the transition gap 139, the cannula 122 is not in fluid communication with the magazine tube 132 when the gate 140 is in the closed configuration.

[0127] Actuation of the actuator 170 from a non-deployed position to a deployed position (described in more detail below) moves or displaces the gate 140 from a closed configuration to an open configuration. FIG. 16B is an enlarged cross-sectional view of the magazine subassembly 130 with the gate 140 in the open configuration. The gate 140 may be considered to be in the open configuration when the distal end 144 of the gate does not cover or extend over the distal end or outlet 133 of the magazine tube 132 such that the outlet 133 of the magazine tube 132 is exposed or open. Additionally, when the gate 140 is in the open configuration, the cannula 122 is in fluid communication with the magazine tube 132. When the actuator 170 is actuated, the actuator 170 contacts the lateral wings 146A, 146B of the gate 140 to push or move the gate 140 downwardly and away from the underside of the magazine tube mount 134. The gate 140 is configured to deflect or bend when the actuator 170 applies sufficient force to transition to the open configuration.

[0128] 18-19, the shuttle subassembly 150 will be described in more detail. FIG. 18 is a perspective view of the shuttle subassembly 150 removed from the injector 100 for purposes of illustration. FIG. 18A is a cross-sectional view taken along line AA in FIG. 18. The shuttle subassembly 150 includes a shuttle body 152, a spring 156, a push rod 160, and a drag wire 164. The shuttle body 152 includes a cavity 151 formed therein for receiving the spring 156. The shuttle body 152 also includes a pair of distally extending fingers 154A, 154B at a distal portion thereof. Each distally extending finger 154A, 154B includes a distal end surface 155A, 155B for interacting with an actuator 170, as described in more detail herein.

[0129] A proximal end 159 of the push rod 160 is secured or retained to the shuttle body 152 such that the push rod 160 moves or translates with the shuttle body 152, as shown in FIG. 18A. The proximal end 159 of the push rod 160 may be secured or retained to the shuttle body 152 via adhesive or welding, or any other suitable mechanical method. In one embodiment, the proximal end 159 of the push rod 160 is retained to the shuttle body 152 via both an adhesive and a mechanical interlock. When assembled into the injector 100, the push rod 160 is coaxially aligned or concentric with each of the magazine tube 132 and the cannula 122, and is sized to be slidably received within the lumens 127, 137 of the magazine tube 132 and the cannula 122, respectively. When the shuttle body 152 moves distally, i.e., in a direction toward the cannula 122, the push rod 152 is configured to enter the lumens 127, 137 of the magazine tube 132 and the cannula 122, respectively, and push or advance the implant 138 distally from the magazine tube 132 into and through the cannula 122, and ultimately through the outlet or distal end 123 of the cannula 122 and into the eye. The push rod 160 has a straight longitudinal profile and may be made of any suitably rigid material, such as a metal or metal alloy (e.g., stainless steel). When in the undeployed state of the injector 100, the distal end 161 of the push rod 160 is disposed proximal to the proximal end or inlet 131 of the magazine tube 132. In one embodiment, the distal end 161 of the push rod 160 is configured prior to deployment to be spaced slightly from the inlet 131 of the magazine tube 132 such that no force or load is applied to the implant 138 prior to operation of the injector 100. After deployment, as seen in Figures 6 and 7, in the deployed state of the injector 100, the distal end 161 of the push rod 160 is disposed distal to the distal end 123 of the cannula 122.

[0130] FIG. 19 shows the spring 156 removed from the shuttle assembly 150 for illustrative purposes only. The shuttle body 152 may be constructed of two halves, thereby forming a cavity 151. The spring 156 is housed or disposed within the cavity 151 of the shuttle body 152. The spring 156 is a constant force spring that is biased or configured to a coiled or unextended configuration. When assembled within the injector 100 in a non-deployed state, the spring 156 extends to an extended configuration. In the extended configuration, at least a portion of the spring 156 is elongated and uncoiled, and its tail or free end 157 is attached to a hook 111 of the window chassis 119. As described in more detail herein, prior to deployment or operation of the injector 100, an actuator 170 is coupled to the shuttle body 152 and configured to hold or maintain the shuttle body 152 in a first position in which the spring 156 extends to the extended configuration. When the actuator 170 is actuated, it releases or disengages the shuttle body 152 therefrom, and the spring 156, by its biasing or shape-setting nature, can resume its coiled or unextended configuration. Because the tail or free end 157 of the spring 156 is attached to the hook 111 of the window chassis 119, the coiling of the spring 156 causes the shuttle body 152 and the push rod 160 to move or translate in a distal direction.

[0131] The shuttle body 152 includes an exterior surface 153 that may include status indicators disposed or formed thereon to alert a user to the relative positioning of the shuttle subassembly 150 within the housing 102. As explained above, the housing 102 includes a window 108 formed therein to allow a user to track the axial or translational movement of the shuttle subassembly 150 within the housing 102. Thus, a user may view the movement of the shuttle subassembly 150 during operation of the injector 100. For example, a distal portion 158A of the exterior surface 153 may include a first status indicator, a middle portion 158B of the exterior surface 153 may include a second status indicator, and a proximal portion 158C of the exterior surface 153 may include a third status indicator. Prior to deployment or actuation of the actuator 170, for example, a user would see the first status indicator of the distal portion 158A displayed through the window 108 of the housing 102 to provide visual feedback to the user that the deployment operation has not yet commenced. When the shuttle subassembly 150 is moving distally from its initial position to its final position within the housing 102, the user will see a second status indicator on the intermediate portion 158B displayed through the window 108 of the housing 102 to provide visual feedback to the user that the shuttle subassembly 150 is moving and deployment is in progress. When the movement of the shuttle subassembly 150 is complete and the shuttle assembly is in its final position within the housing 102, the user will see a third status indicator on the proximal portion 158C displayed through the window 108 of the housing 102 to provide visual feedback to the user that the deployment operation is complete. As noted above, the status indicators may include notations, symbols, indications, or colors. In one embodiment, the first status indicator may be green to indicate that the injector 100 is ready for operation, the second status indicator may be yellow to indicate that deployment of the injector 100 is in progress, and the third status indicator may be red to indicate that deployment of the injector 100 is complete.

[0132] In one embodiment herein, the injector 100 is configured such that the delivery rate of the implant 138 is preset or controlled, the delivery rate being between 2 and 12 seconds. In one embodiment herein, the delivery rate is between 3 and 10 seconds, or about 6.5 seconds, approximately defined as a tolerance of 3.5 seconds. In one embodiment herein, the delivery rate is between 5 and 7 seconds, or about 6 seconds, approximately defined as a tolerance of 1 second. Controlling the delivery rate is important for several reasons. Since the injector 100 is configured to deliver up to three implants 138, each implant must be released sequentially from the injector 100. When the application or target site is within the tissue of the eye, the implants 138 may tend to exit the injector 100 in a generally straight trajectory, toward the posterior surface of the eye. Thus, the length or amount that the implants may travel is limited or restricted due to anatomical constraints. If the implants 138 are released too quickly or rapidly, one or more of the implants 138 may contact and damage the posterior surface of the eye. However, it is also desirable to minimize the overall operation time since the patient cannot move while the device is being operated. The injector 100, and the dispensing procedure, including the overall operation time, should minimize patient discomfort and avoid injury. Thus, the injector 100 includes a means for controlling the delivery rate of the implants 138. The above time ranges refer to the period that elapses from the full actuation of the actuator 170 until all three implants 138 are released from the injector 100 and thus deployment is complete. For example, in one embodiment where the delivery rate is 3-10 seconds, the injector 100 dispenses the total amount of implants 138 in 3.0 seconds or more from the time of full actuation of the actuator 170 to when the trailing end of the last implant clears the distal end 123 of the cannula 122. Furthermore, the total time from full actuation of the actuator 170 to when the trailing end of the edge of the last implant 138 clears the distal end 123 of the cannula 122 is 10.0 seconds or less. The three second dispense time is slow enough to allow the implant 138 to be released into the vitreous to avoid injury to the patient's eye and to avoid damaging the implant 138.Conversely, a total time of 10 seconds is deemed fast enough to support safe insertion, dispensing, and removal of the cannula 122 from the eye. Additionally, the implants 138 are preferably delivered at a constant rate such that one implant does not pop out, while the other implants are slow enough to meet the total delivery rate requirement. In one embodiment, the injector 100 dispenses the total amount of implants 138 at a constant rate or rate such that the time for the fastest implant is no more than 20% faster than the time for the slowest implant.

[0133] More specifically, in one embodiment, the shuttle subassembly 150 further includes a drag wire 164 and a shuttle reducer 190 that interact with each other to control the delivery rate of the implant 138, as described above. The drag wire 164 is secured to the shuttle body 152 such that the drag wire 164 moves or translates with the shuttle body 152. As shown in FIG. 18A, a proximal or first end 163 of the drag wire 164 is attached or secured to a proximal portion of the shuttle body 152, and a distal or second end 165 of the drag wire 164 is attached or secured to a distal portion of the shuttle body 152. In one embodiment, the proximal end 163 and the distal end 165 of the drag wire 164 are secured to the shuttle body 152 via both an adhesive and a mechanical interlock. The drag wire 164 is disposed within the housing 102 and extends adjacent to or along the lower surface of the shuttle body 152. As described in more detail herein, the drag wire 164 interacts with the shuttle decelerator 190 to decelerate the deployment of the shuttle body 152 and the push rod 160. The drag wire 164 may be formed from a metal or metal alloy, such as stainless steel.

[0134] The actuator 170 will be described in more detail with reference to Figures 20-29. Figures 20 and 21 are enlarged perspective and side views, respectively, of the actuator 170 when the injector 100 is in a non-deployed state, while Figure 22 is an enlarged side view of the actuator 170 when the injector 100 is in a deployed state. The actuator 170 extends through an opening 109 in the housing 102 and is readily accessible to a user to manipulate the injector 100 from the non-deployed state of Figures 20-21 to the deployed state of Figure 22. When in the non-deployed position, the actuator 170 protrudes outwardly from the housing 102, with the outer surface 117 of the actuator 170 forming an acute angle of 10-25 degrees with respect to the longitudinal axis of the injector 100, as best seen in Figure 21. To actuate the actuator 170, a user pushes the actuator 170 downward in a direction toward the housing 102. As a result, the actuator 170 is advanced or displaced downwardly by approximately 4 mm and pivots within the housing 102, as described in more detail herein. When in the deployed position, the outer surface 117 of the actuator 170 is generally parallel to the longitudinal axis of the injector 100, and is further generally flush with the outer surface of the housing 102, as best seen in FIG.

[0135] The actuator 170 is mounted within an actuator chassis 172. Referring to FIG. 23, the actuator chassis 172 is secured or held within the window chassis 119 such that the actuator chassis 172 does not move relative to the window chassis 119. The actuator chassis 172 includes a proximal end 171 including a pair of prongs 174A, 174B having inwardly extending posts 175A, 175B, respectively, for coupling to the actuator 170, and a distal end 173. The inwardly extending posts 175A, 175B are best seen in FIGS. 24 and 25. The actuator chassis 172 further includes a pair of tabs 141A, 141B for securing the actuator chassis 172 to the window chassis 119. The tabs 141A are not visible in FIG. 23 but are disposed at opposing locations on the actuator chassis 172. The tabs 141A, 141B are configured to be received within the slots 166A, 166B of the window chassis 119 in a snap-fit ​​arrangement. The actuator chassis 172 defines a generally rectangular opening 176 for receiving the actuator 170 therein.

[0136] 24 , which illustrates the coupling of the magazine subassembly 130 to the actuator chassis 172, the actuator chassis 172 includes a support beam 178 that extends across an opening 176. The support beam 178 defines an opening 179 that is configured to receive a mating snap-fit ​​feature of the magazine subassembly 130. When the magazine subassembly 130 is slid into the housing 102 for final assembly of the injector 102, the snap-fit ​​feature snaps into the opening 179 to hold or secure the magazine assembly 130 to the actuator chassis 172. During operation of the injector 170, the window chassis 119, the actuator chassis 172, and the magazine subassembly 130 (excluding the gate 140) are fixed components that do not move relative to one another.

[0137] In addition to supporting the magazine subassembly 170, the support beams 178 of the actuator chassis 172 also include a channel 180 formed therethrough for receiving the push rod 160, as shown in FIG. 25. The channel 180 functions to coaxially locate the push rod 160 relative to the magazine tube 132 and the cannula 122. As explained above, the push rod 160 is coaxially aligned with each of the magazine tube 132 and the cannula 122 and is sized to be slidably received within the lumens 127, 137 of the magazine tube 132 and the cannula 122, respectively.

[0138] 26A and 26B illustrate the pivotal movement of the actuator 170 relative to the actuator chassis 172 as the actuator 170 is actuated from a non-deployed position to a deployed position. Specifically, FIG. 26A illustrates the relative positioning of the actuator 170 when the actuator 170 is in the non-deployed position, and FIG. 26B illustrates the relative positioning of the actuator 170 when the actuator 170 is in the deployed position. The actuator 170 includes a body portion 181 including an outer surface 117 thereon, the body portion 181 being sized and configured to be received within an opening 176 in the actuator chassis 172. The actuator 170 also includes a pair of proximally extending arms 172A, 172B formed integrally with the body portion 181. The proximally extending arms 172A, 172B define proximal end faces 174A, 174B, respectively, that interact with and releasably couple to the shuttle subassembly 150, as described in more detail herein. Proximally extending arms 172A, 172B also include openings or holes 173A, 173B configured to receive inwardly extending posts 175A, 175B, respectively, of prongs 174A, 174B of actuator chassis 172. Openings or holes 173B are not visible in Figures 26A and 26B but are disposed in opposing locations on proximally extending arms 172B of actuator 170. The coupling between inwardly extending posts 175A, 175B and holes 173A, 173B, respectively, allows actuator 170 to pivot or rotate relative to actuator chassis 172.

[0139] 26A, when the actuator 170 is in the undeployed position, the proximally extending arms 172A, 172B of the actuator 170 are angled downward, i.e., angled parallel to the longitudinal axis of the injector 100, and the proximal end faces 174A, 174B contact and abut the distal end faces 155A, 155B, respectively, of the shuttle subassembly 150. When the actuator 170 is pushed downward by a user for actuation, the actuator 170 advances or displaces downward and pivots within the actuator chassis 172 about the inwardly extending posts 175A, 175B of the actuator chassis 172. Stated another way, the inwardly extending posts 175A, 175B function as fulcrums about which the actuator 170 pivots.

[0140] 27A, when the actuator 170 is in the deployed position, the proximally extending arms 172A, 172B of the actuator 170 extend generally parallel to the longitudinal axis of the injector 100. Additionally, the proximally extending arms 172A, 172B of the actuator 170 also extend generally parallel to and are spaced apart from the distally extending fingers 154A, 154B of the shuttle subassembly 150 such that the proximal end faces 174A, 174B of the actuator 170 no longer contact or abut the distal end faces 155A, 155B, respectively, of the shuttle subassembly 150. When the actuator 170 is in the deployed position, the shuttle subassembly 150 is effectively decoupled or released from the actuator 170 and the shuttle subassembly 150 is free to move or translate by the spring 156 as described above.

[0141] To increase the resistance to pushing the actuator 170 downward for actuation, the actuator chassis 172 may include a pair of teeth 185A, 185B disposed on the distal end 173 of the actuator 170, as shown in FIG. 27. The teeth 185A, 185B extend downward, i.e., in a direction toward the interior of the housing 102, and at an angle radially inward toward the center of the opening 176 in the actuator chassis 172. The actuator 170 includes a pair of knobs 186A, 186B formed on a pair of legs 188A, 188B (see FIGS. 29 and 30A ) that extend from a body portion 181 of the actuator 170. As shown in FIG. 28, the knobs 186A, 186B are configured and positioned to contact and press against the teeth 185A, 185B, respectively, with an interference fit when the actuator 170 is in the undeployed position. 29, when the actuator 170 is pushed downward to the deployed position during its actuation, the actuation force must be sufficient to push the pair of knobs 186A, 186B out of their interference fit with the teeth 185A, 185B in order to depress the actuator 170. The teeth 185A, 185B thus function to increase the minimum actuation force required to actuate the actuator 170 so that the actuator 170 is not overly sensitive to actuation that could lead to inadvertent deployment.

[0142] With the structure of the actuator 170 described above, the operation of the actuator 170 will now be described in more detail with respect to Figures 30A-33. The movement of the actuator 170 from the undeployed position to the deployed position results in two stages of actuation: (1) the actuator 170 moves or displaces the gate 140 from a closed configuration to an open configuration, and (2) the actuator 170 disengages from and releases the shuttle subassembly 150, thereby causing movement or translation of the push rod 160 into and through the magazine tube 132 and the cannula 122 to deliver at least one implant contained within the magazine tube 132 through the cannula 122 to the eye. The first stage of actuation, in which the actuator 170 moves or displaces the gate 140 from a closed configuration to an open configuration, is shown in Figures 30-31, while the second stage of actuation, in which the actuator 170 disengages and releases the shuttle subassembly 150, is shown in Figures 32-33. When the actuator 170 is depressed by a user, a first stage of actuation occurs before a second stage of actuation. The initial depression of the actuator 170 by the user causes the actuator 170 to move or displace the gate 140 from a closed configuration to an open configuration, and when the actuator 170 is further or fully depressed by the user, the actuator subsequently disengages from the shuttle subassembly 150, releasing the shuttle subassembly 150. Thus, the gate 140 is moved to the open configuration before the shuttle subassembly 150 (including the push rod 160) is released.

[0143] The first stage of actuation is shown in Figures 30A, 30B and 31. More specifically, Figure 30A is a perspective view of the actuator 170 and magazine subassembly 130, and Figure 30B is an enlarged cross-sectional view of the injector 100. Figures 30A and 30B show the relative positioning of the actuator 170 and gate 140 when the injector 100 is in a non-deployed state, while Figure 31 shows the relative positioning of the actuator 170 and gate 140 during actuation of the actuator 170. As shown in Figures 30A and 30B, when the injector 130 is in a non-deployed state, the legs 188A, 188B of the actuator 170 are spaced apart from the gate 140. Depression or downward displacement of the actuator 170 causes the legs 188A, 188B of the actuator 170 to press against the gate 140, as shown in Figure 31. Specifically, when actuator 170 is actuated, legs 188A, 188B of actuator 170 contact lateral wings 146A, 146B, respectively, of gate 140, pushing or moving gate 140 downwardly, away from magazine tube mount 134. Thus, gate 140 is moved or displaced from a closed configuration, in which gate 140 covers or blocks the distal end or outlet 133 of magazine tube 132, to an open configuration, in which gate 140 does not cover or block the distal end or outlet 133 of magazine tube 132, as described above with respect to Figures 16A and 16B.

[0144] The second stage of actuation is shown in Figures 32 and 33. More specifically, Figure 32 is an enlarged cross-sectional view of the injector 100 illustrating the relative positioning of the actuator 170 and the shuttle subassembly 150 when the injector 100 is in a non-deployed state, while Figure 33 illustrates the relative positioning of the actuator 170 and the shuttle subassembly 150 when the injector 100 is in a deployed state. As shown in Figure 32, when the actuator 170 is in a non-deployed position, the actuator 170 abuts and locks against the shuttle body 152 of the shuttle subassembly 150. Stated differently, prior to deployment or operation of the injector 100, the actuator 170 is coupled to the shuttle body 152 and is configured to hold or maintain the shuttle body 152 in a first position in which the spring 156 extends to an extended configuration. Proximally extending arms 172A, 172B of actuator 170 are angled downwardly such that their proximal end faces 174A, 174B contact and abut distal end faces 155A, 155B, respectively, of shuttle subassembly 150.

[0145] 33, when the actuator 170 is in the deployed position, the proximally extending arms 172A, 172B of the actuator 170 extend generally parallel to the longitudinal axis of the injector 100. The proximal end faces 174A, 174B of the actuator 170 no longer contact or abut the distal end faces 155A, 155B, respectively, of the shuttle subassembly 150. Stated differently, the actuator 170 no longer contacts the shuttle subassembly 150 and is disengaged or separated therefrom. Full or maximum depression of the actuator 170 releases the shuttle subassembly 150, thereby allowing the spring 156 to resume its unstretched or coiled configuration. The coiling of the spring 156 moves or translates the shuttle body 152 and the push rod 160 distally. Stated another way, when the spring 156 is allowed to return to its coiled configuration, the shuttle body 152 and its attached push rod 160 advance toward the magazine tube 132 .

[0146] In one embodiment, the actuator 170 is configured to lock out after operation of the injector 100. Stated another way, the actuator 170 cannot be reset to a non-deployed position and can only be depressed once such that the injector 100 is a disposable device. As shown in FIG. 34 , where the injector 100 is shown in a deployed state and the shuttle subassembly 150 is shown in perspective, after deployment of the actuator 170, the proximally extending arms 172A, 172B of the actuator 170 are disposed within the shuttle subassembly 150. Thus, the proximally extending arms 172A, 172B cannot be moved or reset to be angled downward due to the placement of the shuttle subassembly 150 thereagainst. Stated another way, after deployment, the shuttle subassembly 150 blocks or prevents the actuator 170 from being reset to a non-deployed position.

[0147] In one embodiment, the injector 100 may include one or more components for controlling or slowing down the speed at which the shuttle subassembly 150 moves within the housing 102. When delivering the implant to the ocular tissue, a very controlled release is desirable to avoid eye damage. If the implant is forcefully released from the injector, the implant may strike the posterior surface of the eye and / or damage the retina of the eye. In one embodiment, the injector 100 is configured to complete delivery within 3-10 seconds from initiation to delivery of the implant.

[0148] To control or slow the speed at which the shuttle subassembly 150 moves within the housing 102, the injector 100 may include a shuttle reducer 190 disposed within the housing 102, as shown in FIGS. 35-37. FIG. 35 is an enlarged cross-sectional view of the shuttle subassembly 150 and shuttle reducer 190 of the injector 100, while FIG. 36 is a perspective view of the shuttle reducer removed from the injector 100 for illustrative purposes. FIG. 37 is an enlarged perspective view showing the drag wire 164 of the shuttle subassembly 190 disposed through the shuttle reducer 190. The shuttle reducer 190 includes a sinusoidal or wavy groove or pathway 192. In one embodiment, the sinusoidal pathway 192 is defined via a plurality of bosses 194. Each boss 194 has a circular or semicircular profile. The plurality of bosses 194 are longitudinally spaced apart from one another and disposed on opposing sidewalls of the pathway 192 to define the sinusoidal pathway 192. As best shown in FIG. 37, the drag wire 164 extends through a sinusoidal path 192. The interaction between the drag wire 164 and the plurality of bosses 194 creates friction that slows down or reduces the speed of movement of the shuttle subassembly 150 within the housing 102. In one embodiment, the plurality of bosses 194 are formed from a plastic material and the drag wire 164 is formed from stainless steel. The shuttle reducer 190 may be secured to the interior surface of the housing 102 and / or the surface of the window chassis 119, so long as the drag wire 164 is positioned to pass through the sinusoidal path 192. Although the shuttle reducer 190 is shown with a sinusoidal path, various shapes or patterns may be utilized to create friction with the drag wire 164.

[0149] Although the drag wire 164 and shuttle reducer 190 are described above to control or slow down the speed at which the shuttle subassembly 150 moves within the housing 102, other components may be used in place of or in addition to the shuttle reducer 190. In another embodiment, the injector includes a rotational damper to control or slow down the speed at which the shuttle subassembly moves within the housing 102. Rotary dampers utilize the principle of fluid resistance to dampen movement and are commercially available through a variety of vendors, including ACE Controls Inc., Farmington Hills, Michigan. Specifically, oil viscosity is utilized to provide the damping force of the damper. The damping torque of the rotational damper is determined by the viscosity of the oil, as well as the spacing and surface area of ​​the internal components of the rotational damper. In embodiments herein, silicone oil or any other suitable viscous fluid may be used as the viscous damping fluid. Silicone oil is commercially available in a variety of viscosities that affect the damping force of the rotational damper. In one embodiment, the rotational dampers described herein may utilize methyphenyl silicone fluid or dimethyl silicone fluid.

[0150] 38 and 39, an embodiment of an injector 3800 is shown that utilizes a rotational damper 3896 to slow or dampen the movement of a shuttle subassembly 3850 within the injector. The injector 3800 is similar to the injector 100 except for the differences in the shuttle subassembly as described herein. FIG. 39 is a perspective view of the shuttle subassembly 3850 removed from the injector 100 for illustrative purposes. The shuttle subassembly 3850 includes a shuttle body 3852, a spring 3856, a push rod 3860, and a rotational damper 3896. A distal portion of the shuttle body 3852 is configured to interact with an actuator 3870 of the injector 3800 as described above with respect to the actuator 170 of the injector 100.

[0151] The push rod 3860 is the same as the push rod 160 described above. The proximal end 3859 of the push rod 3860 is fixed or held to the shuttle body 3852 such that the push rod 3860 moves or translates with the shuttle body 3852. As the shuttle body 3852 moves distally, i.e., in a direction toward the cannula 3822, the push rod 3852 is configured to enter the magazine tube (not visible in FIG. 38 ) and the lumen of the cannula 3822, respectively, and push or advance the implant distally from the magazine tube into and through the cannula 3822 for eventual release through the exit or distal end of the cannula 3822 into the eye.

[0152] The spring 3856 is the same as the spring 156 described above. The spring 3856 is housed or attached to the shuttle body 3852. The spring 3856 is a constant force spring that is biased or configured to a coiled or unextended configuration. Prior to deployment or operation of the injector 3800, as described above with respect to the injector 100, the actuator 3870 is coupled to the shuttle body 3852 and configured to hold or maintain the shuttle body 3852 in a first position in which the spring 3856 extends to an extended configuration. When the actuator 3870 is actuated, the actuator 3870 releases or disengages the shuttle body 3852 therefrom, and the spring 3856, due to the nature of its bias or configuration, can resume its coiled or unextended configuration. The coiling of the spring 3856 moves or translates the shuttle body 3852 and the push rod 3860 in a distal direction.

[0153] The shuttle subassembly 3850 also includes a rotary damper 3896 coupled thereto for controlling or slowing down the speed at which the shuttle subassembly 3850 moves during operation. Rotary dampers 3896 are commercially available through various vendors, including ACE Controls Inc., Farmington Hills, Michigan. In one embodiment, the injector 3800 includes a spring and rotary damper combination configured to obtain a target or desired injection rate. More specifically, the rotary damper is configured to output a specific damping torque depending on the fluid resistance or viscosity of the fluid within the rotary damper. The injection rate of the injector 3800 is determined by several factors, including the damping torque of the rotary damper and the spring constant of the spring 3856. In one embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds of force (0.5 lbf), the rotary damper has a damping torque of 0.035 inch-pounds, and the injector 3800 has an injection speed of 4 to 9 seconds, or about 6.5 seconds with a tolerance of 2.5 seconds. In another embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds of force (0.5 lbf), the rotary damper has a damping torque of 0.035 inch-pounds, and the injector 3800 has an injection speed of 5 to 8 seconds, or about 6.5 seconds with a tolerance of 1.5 seconds. In another embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds of force (0.5 lbf), the rotary damper has a damping torque of 0.035 inch-pounds, and the injector 3800 has an injection speed of 5.5 to 7.5 seconds, or about 6.5 seconds with a tolerance of 1 second. In another embodiment, the spring 3856 has a spring constant for a load of 0.4 pounds of force (0.4 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection speed of 2.5 to 7.5 seconds, or about 5 seconds with a tolerance of 2.5 seconds. In another embodiment, the spring 3856 has a spring constant for a load of 0.4 pounds of force (0.4 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection speed of 3.5 to 6.5 seconds, or about 5 seconds with a tolerance of 1.5 seconds.In another embodiment, the spring 3856 has a spring constant for a load of 0.4 pounds of force (0.4 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection rate of 2.5 to 7.5 seconds, or about 5 seconds with a tolerance of 1 second. In another embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds of force (0.5 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection rate of 1.5 to 6.5 seconds, or about 4 seconds with a tolerance of 2.5 seconds. In another embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection speed of 2.5 to 5.5 seconds, or about 4 seconds with a tolerance of 1.5 seconds. In another embodiment, the spring 3856 has a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotary damper has a damping torque of 0.026 inch-pounds, and the injector 3800 has an injection speed of 3 to 5 seconds, or about 4 seconds with a tolerance of 1 second.

[0154] 40, a method 4098 of using an injector according to an embodiment herein will be described in more detail. The method may be used to inject one or more implants 138 into ocular tissue, for example, through the sclera of the eye, with injector 100 or injector 3800. For illustrative purposes, the method is described herein using injector 100. In one embodiment, after delivery to the ocular tissue, implant 138 is configured to deliver borolanib to the vitreous humor for at least six months.

[0155] Step 4098A of method 4098 involves preparing the patient for the injection procedure. The patient is typically under local or topical anesthesia for intravitreal injection. Appropriate anesthesia and broad spectrum bactericide may be administered to the patient prior to injection. The injection procedure should be performed using standard sterile procedures.

[0156] In step 4098B of method 4098, an injection site may be selected or identified and the lid speculum may be positioned on the patient's eye. In one embodiment, the injection site is 3.5 mm to 4.0 mm posterior to the limbus in the inferior quadrant to ensure an optimal safe location for insertion. Once the injection site is selected, the conjunctiva should be gently displaced using forceps so that the conjunctival and scleral needle entry sites do not line up after the injector is withdrawn. The user may remove the safety cap 104 from the injector 100 so that the injector 100 is ready for injection.

[0157] In step 4098C of method 4098, the distal end 123 of the cannula 122 is positioned adjacent or near an injection site, which is the desired point of entry into the tissue. The injector 100 may be mounted on a stand or supported by a user's hand. The injector 100 may be operated with only one hand in a typical clinical environment.

[0158] In step 4098D of method 4098, distal end 123 of cannula 122 is threaded through tissue to position cannula 122 at a desired location within the patient's tissue for attachment of implant 138. In one embodiment, distal end 123 of cannula 122 is advanced until the distal end of tubular portion 128 of cannula mount 120 abuts the external ocular surface. Stated another way, the portion of cannula 122 that extends distally beyond the distal end of tubular portion 128 of cannula mount 120 is intended for insertion into the eye. Thus, tubular portion 128 of cannula mount 120 functions as a stop to limit the depth of insertion of distal end 123 of cannula 122 into ocular tissue.

[0159] In one embodiment, the distal end 123 of the cannula 122 is inserted at an oblique angle (i.e., an angle that is not perpendicular or 90 degrees). The oblique insertion angle may facilitate self-healing of the entry site after the injector 100 is removed. In one embodiment, the cannula 122 may approach the sclera at an angle of about 45 degrees. Once the bevel of the cannula 122 is fully at the sclera, the cannula 122 should be aimed at the mid-vitreous and the angle of the cannula should be directly perpendicular to the sclera. However, an oblique insertion angle is not necessary, and thus, in another embodiment, the distal end 123 of the cannula 122 is inserted at a near-perpendicular angle (i.e., an angle of about 90 degrees).

[0160] In method step 4098E, the actuator 170 of the injector 100 is actuated to initiate or begin delivery of the implant 138. More specifically, the user actuates or depresses the actuator 170 to deliver the implant 138 out of the distal end 123 of the cannula 122 from an initial position within the magazine tube 132. The distal end 123 of the cannula 122 remains inserted into the ocular tissue until a status indicator of the injector 100 indicates completion of the injection, thereby confirming that the implant 138 has exited the distal end 123 of the cannula and been successfully delivered, as shown in step 4098F of method 4098.

[0161] At method step 4098G, after the injection is indicated as complete via the status indicator as described above, the injector 100 is withdrawn or removed from the tissue. The user may verify placement of the implant 138 within the tissue, administer topical antibiotics to the patient, and / or remove the speculum from the patient, as shown at end 4098H of method 4098.

[0162] It will be understood by those skilled in the art that the specific dimensions or sizes of the components of the injector 100 may vary depending on the number and size of implants 138 being delivered by the injector. For example, if a relatively short implant is being delivered and / or only a single implant is being delivered, the push rod 160 and / or shuttle assembly 150 may need to be longer than if a relatively long implant is being delivered. Similarly, the size or gauge of the cannula 122 may vary depending on the type of implant being delivered. Such variations are within the scope of the present invention to accommodate the delivery of implants of different lengths and numbers with a single injection via the injector 100.

[0163] Although various embodiments according to the present invention have been described above, it should be understood that they have been presented as merely illustrative and exemplary, and not limiting. It will be apparent to those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the present invention. Thus, the breadth and scope of the present invention should not be limited by any of the exemplary embodiments described above, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed in this specification and each reference cited in this specification can be used in combination with the features of any other embodiment. All patents and publications discussed in this specification are incorporated herein by reference in their entirety.

Claims

1. 1. An injector comprising: Housing and a push rod at least partially disposed within the housing; a magazine tube disposed within the housing and having an inlet, an outlet, and a lumen extending from the inlet to the outlet, the magazine tube configured to slidably receive at least one implant therein, the push rod configured to be slidably received within the lumen of the magazine tube; a gate disposed within the housing, the gate having a closed configuration that covers the outlet of the magazine tube and an open configuration that does not cover the outlet of the magazine tube; a cannula disposed outside the housing and having a distal end configured to be inserted into an eye, a lumen of the cannula in fluid communication with the lumen of the magazine tube when the gate is in the open configuration; an actuator, wherein actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the push rod through the magazine tube and the cannula.

2. 10. The injector of claim 1, further comprising a safety cap configured to be removably coupled to the housing to cover the distal end of the cannula when coupled to the housing, the safety cap including a tab that extends into a slot formed in the actuator when the safety cap is coupled to the housing to prevent actuation of the actuator.

3. 10. The injector of claim 1, wherein the housing has a generally tubular structure with asymmetrical fins that include a height greater than the height of the remainder of the length of the housing.

4. The injector of claim 1 , wherein the distal end of the cannula is beveled.

5. 2. The injector of claim 1, wherein the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body being coupled to a spring, the spring including an unextended configuration and an extended configuration, and being biased toward the unextended configuration.

6. The injector of claim 5 , wherein the spring is wound in the unstretched configuration.

7. The injector of claim 5 , wherein the actuator in a non-deployed position holds the shuttle body such that the spring is in the extended configuration.

8. 8. The injector of claim 7, wherein actuation of the actuator from the undeployed position to the deployed position releases the shuttle body and allows the spring to resume the unextended configuration.

9. 9. The injector of claim 8, wherein the actuator abuts and locks against the shuttle body when the actuator is in the non-deployed position, and the actuator does not contact and is disengaged from the shuttle body when the actuator is in the deployed position.

10. 9. The injector of claim 8, wherein the actuator is configured to rotate relative to the shuttle body to transition between the undeployed position and the deployed position.

11. 10. The injector of claim 1, wherein the magazine tube is configured to hold up to three implants, and the injector is configured to deliver the three implants via a single actuation of the actuator.

12. 2. The injector of claim 1, wherein the cannula and the magazine tube are coaxially aligned, and a transition gap extends between the outlet of the magazine tube and the inlet of the cannula.

13. 13. The injector of claim 12, wherein a portion of the gate is disposed within the transition gap when the gate is in the closed configuration, and wherein the portion of the gate is not disposed within the transition gap when the gate is in the open configuration.

14. 10. The injector of claim 1, wherein the housing includes a window formed thereon to allow visual feedback related to the translation of the push rod.

15. 15. The injector of claim 14, wherein the push rod is attached to a shuttle body that is slidably disposed within the housing, and an exterior surface of the shuttle body includes a status indicator thereon for providing the visual feedback through the window.

16. 2. The injector of claim 1, wherein the push rod is attached to a shuttle body slidably disposed within the housing, a drag wire is attached to the shuttle body, and the injector further includes a shuttle reducer disposed within the housing, the shuttle reducer configured to receive the drag wire within its sinusoidal path.

17. 17. The injector of claim 16, wherein the sinusoidal path of the shuttle decelerator is defined by a plurality of bosses, and interaction between the drag wire and the plurality of bosses creates friction that decelerates translation of the shuttle body and attached push rod.

18. 18. The injector of claim 17, wherein the drag wire is formed from stainless steel and the plurality of bosses are formed from a plastic material.

19. 10. The syringe of claim 1, wherein the push rod is formed from stainless steel.

20. The injector of claim 1 further comprising the at least one implant.

21. 10. The injector of claim 1, further comprising a rotational damper disposed within the housing, the rotational damper coupled to the push rod and configured to slow down the rate at which the push rod moves within the housing.

22. 22. The injector of claim 21, wherein the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body coupled to a spring, the spring having a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper having a damping torque of 0.035 inch-pounds, and the injector having an injection rate of 4 to 9 seconds.

23. 22. The injector of claim 21, wherein the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body coupled to a spring, the spring having a spring constant for a load of 0.4 pounds force (0.4 lbf), the rotational damper having a damping torque of 0.026 inch-pounds, and the injector having an injection speed of 2.5 to 7.5 seconds.

24. 22. The injector of claim 21, wherein the push rod is attached to a shuttle body slidably disposed within the housing, the shuttle body coupled to a spring, the spring having a spring constant for a load of 0.5 pounds force (0.5 lbf), the rotational damper having a damping torque of 0.026 inch-pounds, and the injector having an injection speed of 1.5 to 6.5 seconds.

25. An injector comprising: Housing and a push rod at least partially disposed within the housing; a lumen defined within the housing and configured to slidably receive the push rod and at least one implant; a gate disposed within the housing, the gate having a closed configuration that prevents the at least one implant from passing distally through the lumen and an open configuration that does not prevent the at least one implant from passing distally through the lumen; a cannula having a distal end, the distal end disposed outside the housing and configured to be inserted into an eye; an actuator, wherein actuation of the actuator moves the gate from the closed configuration to the open configuration and causes translation of the push rod.

26. The injector of claim 25, wherein the cannula defines at least a portion of the lumen.

27. The injector of claim 25, further comprising a magazine tube disposed within the housing that defines at least a portion of the lumen.

28. An injector as described in claim 25, wherein the gate in the closed configuration covers the outlet of the magazine tube, the gate in the open configuration does not cover the outlet of the magazine tube, and the cannula is fluidly connected to the magazine tube when the gate is in the open configuration.

29. An injector as described in claim 25, wherein the actuator includes a first portion and a second portion, the first portion of the actuator configured to contact the gate to move the gate from the closed configuration to the open configuration, and the second portion of the actuator configured to translate the push rod in the distal direction along the lumen.

30. An injector as described in claim 25, wherein the actuator contacts a proximal portion of the gate to move a distal portion of the gate from the closed configuration to the open configuration, and the proximal portion of the gate is disposed outside the lumen.

Images