An insertable system for delivering active pharmaceutical agents into the eye.

Abstract

A delivery system includes an insertion device and an implant. The insertion device includes a body comprising a button, a pusher wire, a trunk, and a pushing mechanism. The pusher wire includes a first end and a second end. The second end of the pusher wire is coupled to the pushing mechanism. The insertion device also includes an inserter tip including a needle. The inserter tip is configured to be secured to the body. The implant is configured to be loaded into the insertion device. When the button is pressed, the pushing mechanism is triggered, and the pushing mechanism pushes the pusher wire at a constant speed and a predetermined distance to abut against the implant and through the needle.

Description

Priority claims and cross-references to related applications

[0001] This application claims priority and benefit to U.S. Provisional Application No. 63 / 590,204, filed October 13, 2023, and U.S. Provisional Application No. 63 / 642,441, filed May 3, 2024, the entire contents of which (including all forms, drawings and claims) are hereby incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to the delivery of drugs to the eye via an insertion system. Background Technology

[0003] One method of delivering medication to the eye, particularly to the retina, is to inject the medication in pill or tablet form (collectively referred to as a drug implant or implant) into the posterior chamber of the eye. Consistent delivery conditions are crucial to ensuring proper placement of the drug implant while avoiding unwanted contact with certain anatomical structures within the eye. One way to ensure consistent delivery conditions is to use a handheld device that provides easy control for the surgeon or physician.

[0004] Currently available devices may require manual triggering via a push-button motion to deliver the implant. Pushing the button will induce an implantation speed, but this speed is highly dependent on the speed and force applied to the button. For example, if the surgeon presses the button too quickly, the device may deliver the implant at an unintended high speed, potentially resulting in excessive delivery distance and anatomical damage. Alternatively, if the surgeon presses the button too slowly, the device may not deliver the implant with sufficient force to fully push it into the eye; this could lead to inadvertent removal of the implant (e.g., by suction generated when manually withdrawing it from the implantation site).

[0005] Understandably, the inherent speed variations of these widely used button-type devices are problematic for both surgeons and patients, as they can lead to unintended implant placement and / or contact with delicate intraocular anatomy. For these and other reasons, there is a need for new surgical handpieces capable of delivering implants at a consistent speed and distance, unaffected by the speed or force of button presses. Summary of the Invention

[0006] This disclosure includes a handheld device with button triggering and associated features that ensure consistent delivery of the implant to a consistent distance at a consistent speed, regardless of the speed or force applied to the button. This consistent delivery pattern allows the surgeon to focus on device positioning during implantation, knowing that the device will deliver the implant to a consistent distance at a consistent speed, thus avoiding over-implantation and under-implantation. The system disclosed herein generates a consistent delivery pattern, including speed, force, and displacement. Mechanical energy storage can be achieved through springs, flexible elements, gears, etc.

[0007] In view of the disclosure herein, and without limiting the scope of the invention in any way, an insertion device for injecting an implant into the eye is provided in a first aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein). The insertion device may include a body and an inserter tip (tip, apex). The body may include a button comprising a button portion, a first spring, and an arm extending from the button portion, the first spring biasing the arm and button portion in an upward position. The body may also include a wire pusher and a pushing mechanism, the pushing mechanism including a shuttle and a second spring. The wire pusher may include a first end and a second end, wherein the second end of the wire is coupled (coupled, connected) to the shuttle. The inserter tip may include a needle, wherein the inserter tip is detachably coupled to the body. When the button is pressed, the pushing mechanism is configured to move the wire pusher such that a portion of the wire translates through the needle.

[0008] In a second aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the wire pusher can be translated through the needle at a uniform speed, wherein this uniform speed is independent of the force applied to the button by pressing the button.

[0009] In a third aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the body may also include a trunk, wherein the button and actuation mechanism are integrated with the trunk.

[0010] In a fourth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the shuttle includes a first groove and a second groove, wherein the first groove and the second groove are configured as part of an arm for receiving a button.

[0011] In a fifth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the insertion device may include a first non-triggered state (where the portion of the arm is in a first groove), a first triggered state (where the portion of the arm is disengaged from the first groove), and a second non-triggered state (where the portion of the arm is in a second groove).

[0012] In a sixth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the insertion device may include a retaining member and an implant disposed within the needle. The retaining member may apply force to the implant, thereby holding the implant in place within the needle.

[0013] In the seventh aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), pressing the button causes the portion of the push wire to translate through the needle and abut against the implant, wherein the force applied to the implant from the push wire is greater than the force from the retaining member, thereby causing the implant to eject from the needle.

[0014] In the eighth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the implant includes a drug for delivery to the eye.

[0015] In a ninth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), an insert tip is provided configured to be detachably coupled to an insert device for injecting an implant into an eye. The insert tip may include a needle and a cap for receiving the needle. The cap may include one or more recesses, and the one or more recesses may include notches on side surfaces of the recesses. The one or more recesses are configured to secure the insert tip to the insert device.

[0016] In the tenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the needle includes a double-beveled edge.

[0017] In the eleventh aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the inserter tip may include an implant configured for injection into the eye.

[0018] In the twelfth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the implant is disposed within the needle.

[0019] In the thirteenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the inserter tip may also include a retaining member configured to apply force to the implant to abut against the inner surface of the needle.

[0020] In the fourteenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the retaining member includes a distal portion, a proximal portion, and an elongated member located between the distal and proximal portions, wherein the distal portion is configured to apply force to the implant to abut against the inner surface of the needle.

[0021] In the fifteenth aspect of this disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the proximal portion of the retaining member is configured to anchor the retaining member to the needle, and an elongated member is disposed within the needle.

[0022] In the sixteenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the implant is a first implant, and the insertion end also includes a second implant.

[0023] In the seventeenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the first implant and the second implant are disposed in a series (in sequence) within the needle.

[0024] In the eighteenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), a method for inserting an implant into an eye is provided. The method may include inserting a needle of an insertion device into the eye, wherein the insertion device includes a body detachably coupled to an insertion tip, wherein the body includes a button, a wire pusher, and a pushing mechanism, and wherein the insertion tip includes a needle. The method may further include pressing a button on the insertion device to deliver the implant into the eye at a consistent rate through the needle at the insertion tip.

[0025] In the nineteenth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the method may include loading an implant onto the distal end of an insertion device prior to inserting a needle into the eye.

[0026] In the twentieth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the method may include securing the insertion end to the body prior to inserting the needle of the insertion device.

[0027] In a twenty-first aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), a delivery system is provided. The delivery system may include an insertion device comprising a body and an inserter tip. The body may include a button, a pusher wire, a push mechanism, and a trunk, wherein the pusher wire includes a first end and a second end, and wherein the second end of the pusher wire is coupled to the push mechanism. The inserter tip may include a needle, wherein the inserter tip is detachably coupled to the body. The delivery system may also include an implant configured to be loaded onto the distal end of the insertion device. When the button is pressed, the push mechanism is actuated, and the push mechanism moves the pusher wire such that a portion of the pusher wire and the implant are translated through the needle.

[0028] In the twenty-second aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the first end of the pusher wire translates through the end of the needle by a predetermined distance, which is defined by the distance between the end of the needle and the first end of the pusher wire.

[0029] In aspect twenty-three of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the predetermined distance is between 0.75 mm and 1.25 mm.

[0030] In aspect twenty-four of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the implant is translated out of the inserter tip and into the eye at a consistent speed.

[0031] In aspect twenty-five of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the consistent velocity is between 1000 mm / s and 2000 mm / s.

[0032] In the twenty-sixth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the consistent speed is independent of the force applied to the button by pressing the button.

[0033] In aspect twenty-seven of this disclosure (which may be combined with any other aspect listed herein unless otherwise stated), the delivery system also includes a cap configured to cover the needle.

[0034] In aspect twenty-eight of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the actuation mechanism comprises a spring and a shuttle (slider).

[0035] In aspect twenty-nine of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the needle includes a double-beveled edge.

[0036] In the thirtieth aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the needle includes a window.

[0037] In the thirty-first aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the inserter tip includes a tube configured to surround a portion of the needle.

[0038] In the thirty-second aspect of this disclosure (unless otherwise stated, it may be combined with any other aspect listed herein), the button includes a button portion, a first arm extending from the button portion in a first direction, and a second arm extending from the button portion in a second direction, wherein the second arm is configured to hold the actuating mechanism in a compressed position.

[0039] Other features and advantages of the disclosed devices, systems, and methods will be described and apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not exhaustive; in particular, many other features and advantages will be apparent to those skilled in the art from the accompanying drawings and description. Furthermore, no particular embodiment is necessarily required to possess all the advantages listed herein. Moreover, it should be noted that the language used in the specification has been chosen for readability and instructional purposes and is not intended to limit the scope of the inventive subject matter. Attached Figure Description

[0040] The accompanying drawings depict only typical embodiments of the invention and should not be construed as limiting the scope of this disclosure. This disclosure is described and explained with additional specificity and detail using the drawings. The drawings are listed below.

[0041] Figure 1 This is a side view of an insertion system according to an exemplary embodiment of the present disclosure.

[0042] Figure 2 This is an isometric view of the inserter end of an insertion system according to an exemplary embodiment of the present disclosure.

[0043] Figure 3 This is a cross-sectional view of an insertion device according to an exemplary embodiment of the present disclosure.

[0044] Figure 4 This is an isometric view of an insertion system according to an exemplary embodiment of the present disclosure.

[0045] Figure 5 This is an isometric view of the end of the button-actuated inserter according to an exemplary embodiment of the present disclosure.

[0046] Figure 6 This is a cross-sectional view of the end of the button-actuated inserter according to an exemplary embodiment of the present disclosure.

[0047] Figure 7 This is an isometric view of the inserter end after button actuation according to an exemplary embodiment of the present disclosure.

[0048] Figure 8 This is a cross-sectional view of the inserter end after button actuation according to an exemplary embodiment of the present disclosure.

[0049] Figure 9 This is an isometric view of an insertion device according to an exemplary embodiment of the present disclosure.

[0050] Figure 10 This is an isometric view of an insertion device with a protective cap according to an exemplary embodiment of the present disclosure.

[0051] Figure 11This is an isometric view of an insertion device with a protective cap according to an exemplary embodiment of the present disclosure.

[0052] Figure 12 This is a side view of the inserter end of an insertion device according to an exemplary embodiment of the present disclosure.

[0053] Figure 13 This is a top view depicting the interaction between the inserter tip and the body of the insertion device according to an exemplary embodiment of the present disclosure.

[0054] Figure 14A and 14B These are isometric and sectional views of the inserter end with a retaining member according to exemplary embodiments of the present disclosure.

[0055] Figure 14C This is an isometric view of a needle with a pivotable flap for holding an implant, according to an exemplary embodiment of the present disclosure.

[0056] Figures 15A to 15C This is an isometric view of the proximal end of a retaining member according to an exemplary embodiment of the present disclosure.

[0057] Figures 16A to 16C The illustration shows a retaining member according to an exemplary embodiment of the present disclosure.

[0058] Figure 17 This is a side view of an insertion device according to an exemplary embodiment of the present disclosure, with a portion of the housing removed for clarity.

[0059] Figure 18 It is based on exemplary embodiments of this disclosure. Figure 8 The side view of the inserted device, with the trunk removed for clarity.

[0060] Figures 19A to 19C This is a side view of an insertion system according to an exemplary embodiment of the present disclosure.

[0061] Figure 20A and 20B These are bottom and close-up views of the internal components of the insertion device according to this disclosure.

[0062] Figure 21A and 21B It is a cross-sectional view of the end of an inserter containing two implants.

[0063] Figures 22A to 22C This is a side view of an insertion system for delivering multiple implants according to an exemplary embodiment of the present disclosure.

[0064] Figure 23A and 23BThese are bottom and close-up views of the internal components of an insertion device for delivering multiple implants according to this disclosure.

[0065] Figures 24A to 24F The illustration shows the process of deploying multiple implants using an insertion device according to an example of this disclosure.

[0066] Figures 25A to 25D The illustration shows the end of an inserter according to an example of this disclosure.

[0067] Figure 26 The illustration shows the insertion device, which is packaged separately from the main body.

[0068] Figure 27 The insertion device, consisting of a modular insertion tip and a body, is shown. Detailed Implementation

[0069] Other features and advantages of the disclosed devices, systems, and methods will be described and apparent from the following detailed description and accompanying drawings. The features and advantages described herein are not exhaustive; in particular, many other features and advantages will be apparent to those skilled in the art from the accompanying drawings and description. Furthermore, no particular embodiment is necessarily required to possess all the advantages listed herein. Moreover, it should be noted that the language used in the specification has been chosen for readability and instructional purposes and is not intended to limit the scope of the inventive subject matter.

[0070] This disclosure generally relates to insertion devices and systems configured for delivering implants to the eye (e.g., the posterior chamber of the eye). Typically, the insertion device is configured to cut through the sclera of the eye and enter the vitreous body; subsequently, the insertion device delivers the implant into the vitreous body, the retina, or other desired locations within the eye. In some embodiments, the insertion device is configured for intra-anterior chamber injection (e.g., through the anterior chamber of the eye). Delivery sites for the implant may be along the Schlem's canal, within the sclera, through aqueous humor collection ducts, the suprascleral vein, the uveal-scleral outflow pathway, the supraciliary space, and / or the suprachoroidal space.

[0071] Figure 1 A side view of an exemplary insertion device 100 is shown, configured to deliver an implant to the eye, such as the posterior chamber of the eye. In the illustrated embodiment, the insertion device 100 includes a body 110 and an inserter tip (tip, apex) 120.

[0072] The inserter tip 120 may be detachable from the body 110, or alternatively, attached to the body 110. For example, the manufacturing process may involve packaging the body 110 and the inserter tip 120 separately for subsequent assembly by the user. Specifically, the user may attach the inserter tip 120 to the body 110 before performing the intended procedure (e.g., at the surgical site). The modular nature of the inserter tip 120 and the body 110 (as discussed in more detail herein) allows different inserter tips to be used with the same body 110. Alternatively, the manufacturing process may involve attaching the inserter tip 120 to the body 110.

[0073] The inserter tip 120 may include a cap 187, a needle 180 extending from one end of the cap 187, and a tube 185 surrounding the outside of the needle 180. In one example, the user attaches the inserter tip 120 to the body 110 before loading the implant into the inserter device 100. For example, a surgeon may load one or more implants into the inserter device 100 via the end of the needle 180 extending from the cap 187. In an alternative example, the surgeon may load one or more implants into the inserter tip 120 before securing it to the body 110. For example, the surgeon may load the implant onto either side of the needle 180 before securing it to the body 110. Preferably, the surgeon may load the implant onto the distal end of the needle 180 to avoid damaging the needle and injuring the surgeon.

[0074] In another alternative example, the inserter tip 120 is pre-loaded with one or more implants during manufacturing. The manufacturing process may include inserting the implant into the distal end of the needle 180 and securing the implant within the needle 180. The pre-loaded inserter tip 120 may include a colored cap 187, depending on the type or dose of the implant or drug loaded into the inserter tip 120. For example, one type of implant may have a blue cap indicating a first drug or drug dose, while another type of implant may have a red cap indicating a second, different drug or drug dose. This helps prevent surgeons from accidentally implanting the wrong drug into the eye. In some examples, the inserter tip 120 is pre-loaded with one, two, or three implants (as described in more detail herein). Furthermore, it should be understood that different inserter tips 120 (e.g., inserter tips 120 with different colors / dosages) are compatible with the same body 110. That is, different implants and / or different doses of implants can be delivered using the same body 110. While the inserter tip 120 may typically be a disposable component, the body 110 may be reused within a given procedure (i.e., together with multiple inserter tips).

[0075] Once the inserter tip 120 and body 110 are secured to each other and the implant is loaded into the insertion device 100, the surgeon can grasp the outer housing 130 of the body 110 and then insert the needle 180 of the device 100 into the eye. To trigger (activate, start) the insertion device 100, the surgeon presses button 140. By pressing button 140, the implant is ejected from the needle 180 into the eye via mechanical components housed within the body 110, as discussed in detail herein.

[0076] Figure 2 An isometric view of the inserter tip 120 of the insertion device 100 is shown. As previously described, the inserter tip 120 may include a needle 180 and a cap 187. The cap 187 of the inserter tip 120 ( Figure 3 (Not shown) A component protecting the inserter tip 120. Furthermore, as shown, a cover 187 is configured to couple (couple, connect) the inserter tip 120 to the body 110 of the insertion device 100. For example, the cover 187 of the inserter tip 120 may include one or more features configured to couple with one or more features of the body 110 (e.g., the trunk of the body 110).

[0077] The needle 180 at the tip of the inserter includes a lumen configured for the implant to pass through, such as a channel extending along the length of the needle 180. The needle 180 may also be configured to cut into intraocular tissue of the patient's eye. For example, the needle 180 may include a beveled edge, such as a single beveled edge or a double beveled edge. Preferably, the needle 180 includes, for example, a beveled edge. Figure 2 The double-beveled edge is shown.

[0078] In one example, needle 180 is a 22-gauge needle or smaller, for example, a 22-gauge to 32-gauge needle. In a preferred embodiment, the needle is a 24-gauge needle. Needle 180 may or may not be coated. Specifically, needle 180 may be coated, for example, with MDX or other medical-grade silicone coating fluid to improve dispersion.

[0079] like Figure 2 As shown, the inserter tip 120 may include a tube 185 located on the outer surface of the needle 180. In some embodiments, the tube 185 may be a band or a clamp. The tube 185 may increase the rigidity of the needle 180. The tube 185 may also secure the needle 180 within a cap 187 of the inserter tip 120. The tube 185 allows the inserter tip 120 to be compatible with different needle sizes, pusher (expander) sizes, and / or implant sizes. For example, different needle sizes, implant sizes, and pusher sizes are compatible with the inserter tip 120 as long as the outer diameter of the tube 185 surrounding the needle 180 is consistent. The tube 185 may also include an O-ring 186, silicone, or any other elastomeric component. For example, the O-ring 186 may be disposed at one end of the tube 185 as shown.

[0080] Before using the insertion device 100, one or more implants are loaded into the needle 180 of the inserter tip 120. To prevent the implant from moving after being positioned within the needle 180, an O-ring 186 may be positioned outside the needle 180 and hold the implant in place within the needle 180 through a window in the needle 180. For example, the diameter of the implant may be generally smaller than the inner diameter of the needle 180. This allows the user to easily load the implant into the needle 180; however, this configuration provides a gap between the implant and the inner surface of the needle 180. The O-ring 185 minimizes the gap between the implant 200 and the inner surface of the needle 180.

[0081] The cap 187 can be used to protect components of the inserter tip 120. Furthermore, the cap 187 can be configured to couple to the body 110 of the inserter 100. For example, the cap 187 of the inserter tip 120 may include one or more features configured to couple to one or more features of the body 110 (e.g., the housing 130 of the body 110). In the illustrated embodiment, the cap includes two recesses configured to couple to two protrusions on the housing 120, thereby securing the inserter tip to the inserter body 110. It will be understood that other securing mechanisms can be used to attach the inserter tip 120 to the body 110.

[0082] Figure 3 A cross-sectional view of the insertion device 100 is shown, with the insertion tip 120 attached to the body 110, but without the cover 187 for better viewing. The body 110 includes an outer housing 130 configured to protect components housed therein. The housing 130 may include an opening through which a button 140 extends (e.g., along the top side of the housing 130). The housing 130 may include an elongated member configured for gripping by a user. For example, the cross-section of the housing 130 may vary along the length of the housing 130, for example, to enhance the ergonomics of the insertion device 100. Alternatively, the cross-section of the housing 130 may be uniform (consistent) along the length of the housing 130. In various exemplary embodiments, the housing may include one or more ridges to improve grip when the user holds the device. In some examples, the housing 130 may include two portions or two halves that are assembled together to form the housing 130. The two portions may be symmetrical or asymmetrical. When symmetrical, it should be understood that housing 130 (more generally insertion device 100) is configured for use with both hands.

[0083] In this illustrated embodiment, the body 110 also includes a main trunk 170, which is secured within the housing 130 by internal components within the housing 130. For example, the main trunk 170 may include one or more holes into which bolts protruding from the inside of the housing are fitted, thereby securing the main trunk 170 to the housing 130.

[0084] The main frame 170 acts as an internal housing, supporting the internal mechanical components of the insertion device 100. As shown, the internal mechanical components include a button 140, a pusher 150, and a pusher mechanism 160. The button 140 and the pusher mechanism 160 can be mounted onto the main frame 170 of the body 110. For example, the main frame 170 may include one or more features configured to couple with the button 140 and / or the pusher mechanism 160. Using the main frame 170 ensures that most of the precision engineering is focused on a single critical component of the insertion device 100.

[0085] The insertion device 100 may include a button 140 configured to trigger the insertion device 100 and deliver an implant into the eye. In some embodiments, the button 140 may include a button portion 140a, a first arm 140b extending from the button portion 140a in a first direction, and a second arm 140c extending from the button portion 140a in a second direction. Typically, the button portion 140a is configured to be pressed by a user, for example, by the user's thumb or finger. Before the button portion 140a is pressed, the insertion device is generally positioned such that... Figure 3 The non-triggered state is shown. When the user presses button 140a, the insertion device is triggered, pushing the actuating mechanism 160 and the pusher wire 150 forward, which will be discussed in more detail herein. In some embodiments, button 140 and device 100 are configured for single-use actuation. That is, once "triggered," the actuating mechanism 160 and pusher wire 150 are pushed forward and may subsequently remain locked in this forward position.

[0086] As shown in the figure, the first arm 140b of the button 140 extends along the length of the body 110 of the insertion device 100. A first end of the first arm 140b can be attached to the button portion 140a, while a second end of the first arm 140b can engage with the main body 170. In this illustrated embodiment, the second end of the first arm 140b is biased upwards, thereby applying a force to a portion of the main body 170. Since the main body 170 is in a fixed state fixed to the housing 130, the force between the first arm 140b and the main body 170 biases the button portion 140a upwards. In some examples, to press the button portion 140a, the user can apply a force to the button portion 140a greater than the load acting on the first arm 140b.

[0087] In the illustrated embodiment, the first arm 140b includes a pivot point 141 about which the button 140 pivots when the user presses the button portion 140a. The trunk 170 may be further configured to couple to the pivot point 141 of the first arm 140b. As shown, the pivot point 141 may be circular or other smooth shapes.

[0088] The second arm 140c can extend from the button portion 140a and can engage with the push mechanism 160. In the non-triggered state, the second arm 140c keeps the push mechanism in a compressed state.

[0089] In the illustrated embodiment, the actuating mechanism 160 includes a shuttle (slider) 160a and a spring 160b, the spring 160b being coupled to a first end of the shuttle 160a. In the non-triggered state, the spring 160b is compressed, storing potential energy. For example, one end of the spring 160b may contact and compress against the surface of the main body 170.

[0090] The second end of the shuttle 160a may include one or more features configured to engage with features on the second arm 140c, thereby allowing the second arm 140c to hold the push mechanism 160 in a compressed state. In some embodiments, the shuttle 160a may include a groove around its periphery (circumference), and the second arm 140c may include a protrusion adapted in the groove of the shuttle 160a. When a user presses button 140, the second arm 140c moves relative to the shuttle 160a, thereby disengaging the protrusion from a groove in the shuttle 160a to allow the shuttle 162 to move axially, thereby triggering the push mechanism 160. Triggering the push mechanism 160 results in the release (partial or complete) of stored mechanical energy through the compression spring 160b. It is understood that other mechanisms for storing potential energy may be used instead of the spring 160b. For example, the push mechanism 160 may include one or more springs, flexible components, and / or gears to store potential energy and release (at least a portion) of the potential energy as kinetic energy upon triggering.

[0091] The pusher 150 can be coupled to the actuation mechanism 160, for example, at the shuttle 160a. In some examples, the pusher 150 can be disposed within the shuttle 160a, for example, through a channel in the shuttle 160a. When the second arm 140c is released from the shuttle 160a, the spring 160b forces the shuttle 160a forward, thereby forcing the pusher 150 forward at a consistent speed. It should be understood that the force with which the surgeon presses the button portion 140a is irrelevant, as long as the force is sufficient to release the second arm 140c from the shuttle 160a. Therefore, the consistent speed (achieved by compressing the spring 160b) is independent of the pressing force at the button portion 140a. In some embodiments, the average speed of the pusher 150 is between 100 mm / s and 8000 mm / s. Preferably, the average speed of the pusher 150 is between 1000 mm / s and 2000 mm / s.

[0092] As shown in the illustrated embodiment, the main body 170 may include a surface 170a (e.g., a wall) located on the path of the shuttle 160a to limit the distance traveled by the shuttle 160a after actuation of the spring 160b. This may also limit the distance traveled by the pusher 150, such that the pusher 150 travels a predetermined distance. For example, when the inserter end 120 is secured to the body 110, the pusher 150 may be positioned within the lumen of the needle 180. When button 140 is pressed, the pusher 150 may pass through the needle 180 and extend beyond the end of the needle 180 by a predetermined distance. In some embodiments, the pusher 150 moves a predetermined distance beyond the end of the needle 180 by 0.1 mm to 3 mm. Preferably, the predetermined extension distance is 0.75 mm to 1.25 mm.

[0093] The pusher wire 150 can have any suitable shape or size. For example, the pusher wire can have a circular cross-section. The size of the pusher wire 150 can be optimized according to the size of the needle 180 and the implant to prevent air bubbles during implant delivery. In one example, the pusher wire 150 is made of stainless steel and / or titanium. The pusher wire 150 can be colored, for example, a different color from the needle 180, to distinguish it from the needle 180. For example, the pusher wire 150 can be neon green or a similar fluorescent color. Color differentiation helps a user (e.g., a surgeon or physician) determine whether the insertion device 100 has been triggered. In some embodiments, the insertion device provides the user with another indication that the insertion device has been triggered, such as tactile or auditory feedback.

[0094] After the user secures the inserter tip 120 to the body 110, the lumen of the needle 180 receives at least a portion of the retractor wire 150. If the surgeon is loading an implant into the needle 180, the surgeon may push the implant into the needle 180 to bring it into contact with the retractor wire 150. Alternatively, the surgeon may load the implant into the distal end of the needle 180 before securing the inserter tip 120 to the body 110. The retractor wire 150 may interact with the implant as the inserter tip 120 interacts with the body 110. When the surgeon presses button 140 and the retractor wire 150 moves forward, the retractor wire 150 moves and contacts the implant. Thus, the retractor wire 150 pushes the implant 200 from the distal end of the needle 180 and pushes it into a portion of the eye (e.g., the posterior chamber). The controlled distance traveled by the retractor wire 150 and the associated mechanism (mechanics) of the spring 160b allow the implant to be pushed into the eye at a consistent speed and consistent depth, regardless of the force applied by the surgeon when pressing button 140. The implant speed is designed to be high enough to ensure sufficient implantation depth; for example, this ensures that the removal device 100 from the eye does not generate suction that would cause the implant itself to be removed.

[0095] like Figure 4As shown, in some examples, the insertion device 100 includes a protective cap 190 configured to protect the needle 180 and the inserter tip 120 during transport and operation. Specifically, the protective cap 190 can provide protection to the user when the inserter tip 120 is secured to the body 110. The protective cap 190 may be transparent or include an optical window to ensure the presence of the implant can be confirmed without removing the cap 190. The user can remove the protective cap 190 from the insertion device 100 before use. The protective cap 190 can be secured to the inserter tip 120 or the body 110 by any fastening method.

[0096] The protective cap 190 at the inserter end 120 can act as a locking mechanism to prevent the button 140 from being accidentally pressed during transport and operation. For example, as Figure 4 As shown, the protective cap 190 may include an arm 190c 192c positioned below the button 140 to prevent the button from being pressed. In some embodiments, the protective cap 190 may also include one or more tabs (ears) 190a that engage with grooves along the housing 130 or inserter end 120. A user can squeeze or separate the tabs 190a to more easily remove the protective cap 190 from the inserter end 120. Furthermore, the tabs 190a of the protective cap 190 may include grooves or protrusions to improve the user's grip during cap removal.

[0097] Figures 5 to 8 The inserter end 120 is shown before and after button 140 is pressed. Figure 5 and Figure 6 The inserter tip 120 is shown before the insertion device 100 is triggered and before the implant is inserted into the eye. The pusher wire 150 remains fully positioned within the needle 180 of the insertion device 100. Figure 7 and Figure 8 The inserter tip 120 is shown after the insertion device 100 is triggered and after the implant is inserted into the eye. The pusher wire 150 extends beyond the tip of the needle 180 by a predetermined distance.

[0098] like Figures 5 to 8 As shown, needle 180 may include a window 180a, such as an opening in needle 180. A surgeon can use the window 180a of needle 180 to visually confirm the presence of an implant in insertion system 100. For example, as... Figure 5 and Figure 6 As shown, the implant can be seen through the window before the insertion system is triggered.

[0099] Surgeons can also visually confirm the deployment of the implant using window 180a after pressing a button. For example, as... Figure 7 and Figure 8As shown, if the surgeon sees the retractor 150 in window 185, the surgeon knows that the retractor has pushed the implant out of the insertion device 100. In some embodiments, the retractor 150 is light-colored to help the surgeon better distinguish the retractor 150 from the needle 180. In some embodiments, the insertion device provides the user with another indication that the insertion device has been triggered (e.g., tactile or auditory feedback).

[0100] Figure 9 An isometric view of an exemplary insertion device 200 configured according to another example of this disclosure for delivering an implant into the eye is shown. First, it should be noted that any features or aspects of the insertion device 100 discussed above can also be implemented in the insertion device 200; similarly, it should be noted that any features or aspects of the insertion device 200 discussed below can also be implemented in the insertion device 100. As... Figure 9 As shown, the insertion device 200 includes a body 210 and an inserter tip 220. In some examples, the body 210 and inserter tip 220 of the insertion device 200 may be combined with or be the same as any embodiment of the body 110 and inserter tip 120 of the insertion device 100.

[0101] like Figure 10 As shown, in some examples, the insertion device 200 includes a protective cap 290 configured to protect the needle 280 and the inserter tip 220 during transport and operation. The user removes the protective cap 290 from the insertion device 200 before use. The protective cap 290 can be secured to the inserter tip 220 or the body 210 by any fastening method.

[0102] Similar to the protective cap 190, the protective cap 290 of the inserter end 220 can act as a locking mechanism to prevent the button 240 from being accidentally pressed during transport and operation. For example, as Figure 10 As shown, the protective cap 290 may include an arm 290c located below the button 240 to prevent the button 240 from being pressed. The arm 290c extends from the button 240 along the length of the insertion device 200 toward the inserter end 220. The protective cap 290 may also include one or more tabs 290a that engage with grooves along the housing 230 or the inserter end 220. A user can squeeze or separate the tabs 290a to more easily remove the protective cap 290 from the inserter end 220. Furthermore, the tabs 290a of the protective cap 290 may include grooves or protrusions to improve the user's grip during cap removal.

[0103] like Figure 11As shown, in some examples, the insertion device 200 includes a protective cap 290 for the inserter tip 220 and a mechanism 295 separate from the protective cap 290 for preventing accidental pressing of the button 240. This protects the inserter tip 220 during transport and operation and prevents pressing the button 240 when the inserter tip 210 and the body 220 are separated. In some embodiments, the mechanism 295 for preventing the button 240 from being pressed includes a notch 295a extending below the button 240 and an arm (not shown) detachably connected to a portion of the body 210 (e.g., the trunk). In some embodiments, the mechanism 295 includes a tab 295b for user interaction. The user can apply pressure to the tab 295a before surgery to remove the mechanism 295. That is, the user pushes the tab 295a with their thumb and pivots the entire mechanism 295 off the button 240; the user can then freely press the button 240 (e.g., to trigger the insertion device 200).

[0104] Figure 12 An isometric view of the inserter tip 220 of the insertion device 200 is shown. Similar to the inserter tip 120, the inserter tip 220 may include a needle 280 and a cap 287. The cap 287 of the inserter tip 220 can protect the components of the inserter tip 220. Furthermore, as shown, the cap 287 is configured to couple the inserter tip 220 to the body 210 of the insertion device 200. For example, the cap 287 of the inserter tip 220 may include one or more features configured to couple with one or more features of the body 210 (e.g., the trunk of the body 210). In the illustrated embodiment, the cap 287 includes one or more recesses 287a, 287b, 287c configured to couple with one or more protrusions on the body 210. Each recess (e.g., recess 287a) includes a notch (e.g., notch 287d) extending from one side of the recess 287a. In an exemplary embodiment, the grooves 287a-c are geometrically keyed so that the inserter tip 220 can only couple to the body 210 in a specific orientation. It should be understood that the number of grooves 287a-c may vary in alternative embodiments.

[0105] like Figure 13As shown, to secure the inserter tip 220 to the inserter body 210, the user aligns the protrusion 210a of the body 210 with the groove 287a and pushes the inserter tip 220 to move the protrusion 210a axially into the groove 287a. Once the protrusion 210a is positioned within the groove 287a, the user twists the inserter tip 220 relative to the body 210 (or twists the body 210 relative to the inserter tip 220) to secure the protrusion 210a in the notch 287d of the groove 287a. In one embodiment, the notch 287d is configured to press against the protrusion 210 upon twisting. If the user wishes to remove the inserter tip 220 from the body 210, the user can easily twist the inserter tip 220 to remove the protrusion 210a from the notch 287d and then move the inserter tip 220 axially away from the body 210. This configuration allows the user to easily attach or remove the inserter tip 220 from the body 210. However, it is understood that other securing mechanisms can be used to attach the inserter tip 220 to the body 210.

[0106] In some examples, axial movement of the inserter tip 220 relative to the body 210 engages internal components of the body 210 to prepare for or store energy for use of the insertion device 200. For example, as discussed in more detail herein, when the inserter tip 220 pushes against the body 210, it compresses a spring within the body 210. Subsequent torsion of the inserter tip 220 locks the spring in its compressed state, allowing it to store potential energy. When the implant is delivered from the insertion device 200, internal mechanisms of the insertion device 200 cause this potential energy to be converted into kinetic energy, ultimately pushing the implant into the eye. This configuration allows the user to reuse the body 210 with multiple inserter tips 220, depending on the type or dosage of the medication.

[0107] like Figure 14A As shown, before using the insertion device 200, one or more implants 300 are loaded into the needle 280 of the inserter tip 220. To prevent the implant 300 from moving after being positioned within the needle 280, a retaining member 310 is disposed within the needle 280 to hold the implant 300 in place within the needle 280. For example, the diameter of the implant 300 may be generally smaller than the inner diameter of the needle 280. This allows the user or manufacturer to easily load the implant 300 into the needle 280; however, this configuration provides a gap between the implant 300 and the inner surface of the needle 280. The retaining member 310 minimizes the gap between the implant 300 and the inner surface of the needle 280. The retaining member 310 may be composed of a thin layer of polyimide, stainless steel, or other suitable materials. In some examples, the retaining member is flexible.

[0108] In some examples, the retaining member 310 includes a thin and elongated body with at least one tab 310a at its distal end. Figure 14B As shown, the tab 310a contacts the side surface of the implant 300, pressing the implant 300 against the inner wall of the needle 280, thereby creating an interference or frictional fit between the needle 280 and the implant 300. In some examples, the tab 310a is generally triangular, hook-shaped, or any suitable shape.

[0109] In an exemplary embodiment, the needle 280 includes additional or alternative features for retaining the implant 300. For example, such as... Figure 14C As shown, needle 280 may include a pivotable flap 312 fixed to the distal end of needle 280. In one embodiment, the pivotable flap 312 is integrally formed with needle 280 (e.g., a continuous material); in other embodiments, the pivotable flap 312 is coupled to needle 280 (e.g., as a separate component). It should be understood that the pivotable flap 312 may be made of the same or different material as needle 280. For example, the pivotable flap 312 may be made of stainless steel, another metal (such as copper), polymer, rubber, or other similar materials. The choice of material can determine the overall flexibility of flap 312. The pivotable flap 312 may extend from the top surface of needle 280 to the inner surface of needle 280. In some embodiments, the pivotable flap 312 contacts the inner surface of needle 280, which is approximately 180 degrees away from the top surface from which the pivotable flap 312 extends.

[0110] In response to a threshold force, such as the delivery force of implant 300, flap 312 is configured to pivot outward (i.e., away from the inner surface), thereby allowing implant 300 to be ejected from the distal end of needle 280. Advantageously, flap 312 is configured such that any force below the threshold force is insufficient to pivot flap 312 outward. That is, flap 312 helps physically prevent implant 300 from unintentionally falling out of needle 280 (e.g., during transport or operation). Flap 312 can be configured to pivot under a given force based on material selection and / or overall geometry. For example, a smaller cross-section of flap 312 will result in a lower threshold force for pivoting; a larger cross-section of flap 312 will result in a higher threshold force for pivoting.

[0111] In some embodiments, a user inserts the retaining member 310 into the needle 280 from its distal end and pushes the retaining member 310 along the length of the needle 280; in other embodiments, the retaining member 310 is inserted into the needle 280 during manufacturing. The distal end of the retaining member 310 may include features for anchoring the retaining member 310 to the needle 280 to ensure proper fixation of the implant 300 in the needle 280. Figures 15A to 15C Different configurations of features at the distal end of the retaining member 310 according to an example of this disclosure are shown. For example... Figure 15BAs shown, in some examples, feature 310b at the distal end of retaining member 310 includes a hoop configured to surround the outer diameter of needle 280. For example... Figure 15A and Figure 15C As shown, in other examples, feature 310b at the distal end of retaining member 310 includes a circular or rectangular tab with a width greater than the inner diameter of needle 280. This prevents further axial movement of retaining member 310 after the distal end of retaining member 310 is positioned near the proximal end of needle 280.

[0112] Figures 16A to 16C The illustrations show different embodiments of the retaining member 310 according to examples of this disclosure, which are similar to... Figures 15A to 15C Those embodiments. For example, the proximal end 310a of the retaining member 310 may be flat (flat), with a width greater than the shaft (axis) of the retaining member 310, such as... Figure 16A and Figure 16B As shown, or it can be curved, such as Figure 16C As shown. In some embodiments, the distal end 310b of the retaining member 310 may be flat, for example... Figure 16A and Figure 16C The flat geometry shown, or it could be as follows Figure 16C The hoop shown.

[0113] Figure 17 A side view of the internal components of the insertion device 200 is shown, with the insertion tip 220 secured to the body 210. Similar to the insertion device 100, the body 210 of the insertion device 200 includes an outer housing 230 configured to protect components housed therein, a trunk 270, an actuation mechanism 260, a button 240, and a pusher wire 250. The button 240 and the actuation mechanism 260 can be mounted to the trunk 270 of the body 210. For example, the trunk 270 may include one or more features configured to couple with the button 240 and / or the actuation mechanism 260. In the illustrated embodiment, the trunk 270 includes a cylindrical member generally surrounding the actuation mechanism 260 and the pusher wire 250. The trunk 270 may include one or more protrusions configured to mate the inserter tip 220 with the body 210 of the insertion system 200. The use of the trunk 270 ensures that most of the precision engineering is focused on a single critical component of the insertion device 200.

[0114] Figure 18 yes Figure 17The insertion device 200 has its main stem 270 removed to make internal components visible. In some embodiments, the button 240 may include a button portion 240a, a first arm 240b extending from the button portion 240a toward the main stem 270, and a spring 240c disposed between the top surfaces of the button portion 240a and the main stem 270. The spring 240c biases the button 240 in an upward position. For example, the spring 240c is disposed in a direction substantially the same as the direction in which the button portion 240a is allowed to translate.

[0115] Typically, the button portion 240a is configured to be pressed by a user, for example, via the user's thumb or finger. Before the button portion 240a is pressed, the insertion device 200 is generally positioned as follows: Figure 17 and Figure 18 The non-triggered state is shown. When the user presses the button 240a and compresses the spring 240c, the insertion device 200 is triggered, pushing the push mechanism 260 and the push wire 250 forward, which will be discussed in more detail herein. Once the user removes the force applied to the button 240a, the spring 240c biases the button 240a upward, causing the button 240a to return to the upwardly biased position.

[0116] In the illustrated embodiment, the actuation mechanism 260 includes a shuttle 262 and a spring (not shown), the spring being coupled to one end of the shuttle 262. In the non-triggered state, the spring is compressed, thereby storing potential energy. For example, the spring can be compressed against the surface of the main body 270 and the end of the shuttle 262.

[0117] like Figure 17 and Figure 18 As shown, the first arm 240b can extend from the button portion 140a and can engage with the actuation mechanism 260 through a groove in the main body 270. A portion of the shuttle 262 may include one or more features configured to engage with features on the first arm 240b of the button 240 to prevent axial movement of the shuttle 262 and to retain the spring in a compressed state. For example, the shuttle 262 includes one or more grooves, such as around the periphery (circumference) of the shuttle. The first arm 240b includes protrusions that adapt in one or more grooves of the shuttle 262.

[0118] When the user presses button 240, the first arm 240b moves relative to the shuttle 262, disengaging the protrusion from a groove in the shuttle 262, thereby allowing the shuttle 262 to move axially and triggering the push mechanism 260. Triggering the push mechanism 260 causes the release (partial or all) of stored potential energy via a compressed spring. It is understood that, alternatively, other mechanisms for storing potential energy may be used instead of the spring. For example, the push mechanism 260 may include one or more springs, flexible components, and / or gears to store potential energy and release (at least a portion) of the potential energy as kinetic energy upon triggering.

[0119] Figures 19A to 19C The illustration shows an internal view of an exemplary insertion device 400, similar to insertion device 200 but with modified internal components. Insertion device 400 can insert a single implant 300 into a patient's eye. Figure 19B and Figure 19C As shown, a portion of button 440 may extend through a channel in shuttle 462. The shuttle may also include an additional channel extending from the first channel, which allows shuttle 462 to move relative to button 440. In some embodiments, the first channel is perpendicular to the additional channel. Main shaft 470 and / or shuttle 462 may include a recess configured to receive the portion of button 440. When button 440 is pressed, button 440 may disengage from the recess 462a in shuttle 462, thereby allowing shuttle 462 (and the pusher wire) to move forward.

[0120] Figure 20A and Figure 20B The illustration shows a bottom view and a close-up view of the shuttle 462 and button 440 of the insertion device 400. As shown, in the non-triggered state, the end of button 440 can be positioned within a recess 462a of shuttle 462, allowing spring 440c to bias button 440 into an upward position. When button 440 is pressed, button 440 disengages from recess 462a, allowing shuttle 462 to be pushed forward such that the bottom portion of button 440 passes through channel 462b of shuttle 462. As shown in the illustrated embodiment, shuttle 462 may include a channel for receiving push wire 450, such that movement of shuttle 462 causes movement of push wire 450.

[0121] As previously stated, the insertion systems (100, 200, 400, etc.) described herein can be used to insert one or more implants 300 into the eye. Figure 21A and Figure 21B The illustration shows a cross-sectional view of the inserter tip 520, in which two implants 300a, 300b are loaded into the needle 580. The implants 300a, 300b can be held in place by a retaining member 310 as previously described. In the illustrated embodiment, the retaining member 310 may include one or more grooves along its length. Figure 21A ) or one or more protrusions ( Figure 21B The inserter tip 520, which has multiple implants 300a and 300b, is used to secure the implants 300a and 300b within the needle 580. The inserter tip 520 can be used to insert multiple implants into a patient's eye.

[0122] Figures 22A to 22C The illustration shows the internal components of an insertion device 500 configured to deliver multiple implants into a patient's eye. Except that the shuttle is modified to allow for multiple releases, the insertion device 500 is similar to insertion devices 100, 200, and 400. For example, as... Figure 22B and Figure 22C As shown, the shuttle 562 may include two portions: a first portion 562a for releasing a first implant and a second portion 562b for releasing a second implant. The shuttle 562 may include a post 562c between the first portion 562a and the second portion 562b to prevent axial movement of the shuttle 562 after the first implant has been deployed. In some embodiments, the shuttle 562 includes a recess 562c between the first portion 562a and the second portion 562b. The button 540 is configured to engage the recess 562c after the device releases the first implant and before the device releases the second implant.

[0123] Figure 23A and Figure 23B The illustration shows a bottom view and an enlarged view of an insertion device 500 for deploying multiple implants. As shown, in the non-triggered state, the end of button 540 can be positioned within a first recess 562e of shuttle 462, allowing spring 540c to bias button 540 in an upward position. When button 540 is pressed, button 540 disengages from recess 562e, allowing shuttle 562 to be pushed forward such that the bottom portion of button 540 passes through channel 562g of shuttle 562. As shown in the illustrated embodiment, shuttle 462 may include a channel for receiving push wire 550, such that movement of shuttle 562 causes movement of push wire 550.

[0124] Figures 24A to 24F The illustration shows the process of deploying multiple implants using the insertion device 500. Figure 24A The illustration shows the insertion device in a non-triggered state, where button 540 is biased upwards. Figure 24B The illustration shows button 540 being pressed in the direction of the arrow. The force of the user pressing button 540 for the first time causes button 540 to disengage from the recess 562e of shuttle 562, resulting in the conversion of some potential energy stored in the spring into kinetic energy. The release of energy causes shuttle 562 to move forward in the direction of the arrow, thereby deploying the first implant, such as... Figure 24C As shown. The shuttle 562 moves forward until the button 540 contacts the post 562c between the first part 562a and the second part 562b of the shuttle 562. Then, the button 540 engages with the second recess 562d between the first part 562a and the second part 562b of the shuttle 562, which biases the button 540 back to the upward position and into a non-triggered state, ready for a second press, as shown. Figure 24E As shown.

[0125] Pressing button 240 a second time disengages button 540 from the second recess 562d of shuttle 562, causing another portion of the potential energy stored in the spring to be converted into kinetic energy. This additional energy release propels shuttle 562 forward, thereby deploying the second implant, such as... Figure 24EAs shown. After the second implant is deployed, button 540 engages with the third recess 562f at the end of shuttle 562, which again biases button 540 back to the upward position and enters the non-triggered state, as shown. Figure 24F As shown. Although shuttle 562 includes two parts 562a, 562b for delivering two implants, it is understood that the insertion device may be modified to include three, four or more parts for delivering three, four or more implants.

[0126] Figures 25A to 25D An inserter tip 520 according to another example of the present disclosure is illustrated. The inserter tip 520 can be used with insertion devices (100, 200, 400, etc.) according to examples of the present disclosure. In one embodiment, the proximal end of the needle 580 may include a funnel 582 or other alignment mechanism. When the inserter tip 520 is secured to the body, the funnel 582 can assist in aligning the pusher wire 550 relative to the needle 520. For example, when the inserter tip 520 is secured to the body, the pusher wire 550 may contact the inner surface of the funnel 582, thereby guiding the pusher wire into a channel in the needle. In some embodiments, a portion of the proximal end of the needle 580 is removed to form a groove through which the pusher wire 550 can be laterally loaded into a channel in the needle 580.

[0127] As previously mentioned, in some embodiments, the inserter tip 520 is packaged separately from the body 510 during manufacturing. Figure 26 The illustration shows the inserter tip 520 packaged in a separate package from the body 510. In some embodiments, the inserter tip 520 is packaged in a sterile tray 600. The body 510 can be attached to the inserter tip 520 while it is still in the package. This maintains the sterility of the needle before use and prevents accidental needlestick injuries before surgery. To connect the body 510 and the inserter tip 520, the user can move the body 510 to the end of the inserter tip 520 exposed from the package. The user can then rotate the body 510, for example, a quarter turn or half turn, to lock the inserter tip 520 onto the body 510. Figure 27 As shown, after the inserter tip 520 and body 510 are locked together, the user can remove the inserter tip 520 together with the body 510 from the packaging. As previously described, the inserter tip 520 may include a protective cap 590. Before the procedure begins, the user removes the protective cap 590 to expose the needle of the insertion device. The protective cap 590 and / or the sterile tray 600 may be colored according to the type or dose of the implant or medication loaded into the inserter tip 520. For example, one type of implant may have a blue cap to indicate the first medication or dose, while another type of implant may have a red cap to indicate a second, different medication or dose. This helps prevent the surgeon from accidentally implanting the wrong medication into the eye.

[0128] Packaging the inserter tip separately from the main body offers several advantages. First, the inserter tip can be pre-loaded with implants that may require refrigerated storage. Separating the implant from the main body saves storage space, as only the inserter tip containing the implant needs to be stored in the refrigerator. Furthermore, multiple inserter tips can be used with the same main body. The inserter tip, or its packaging, can be colored according to the type of medication required for the implant. This makes it easier for users to determine the type of medication needed before surgery and attach the inserter containing the specific medication to the main body.

[0129] In one example, the implant delivers an active agent to the eye. In some embodiments, the agent includes a multi-kinase inhibitor (MKI), such as, but not limited to, axitinib (INLYTA®), dasatinib (SPRYCEL®), erlotinib (TARCEVA®), imatinib (GLIVEC®), nilotinib (TASIGNA®), pazopanib (VOTRIENT®), sunitinib (SUTENT®), cabozantinib, lenvatinib, regorafenib, sorafenib, and vandetanib. In some embodiments, the agent may be one or more transiently acting silencing RNAs (tasiRNAs). In some embodiments, MKIs have been shown to clinically inhibit vascular leakage in the treatment of wet age-related macular degeneration (wAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Approved anti-VEGF drugs are effective; however, their short duration of action imposes a burden on clinical practice and patients. The insert described herein provides long-acting intravitreal release, effectively managing the disease for approximately 6 to 12 months.

[0130] The tolerability and efficacy of intravitreal MKI implants in inhibiting retinal vascular leakage were investigated in a DL-AAA Dutch rabbit model. DL-AAA rabbits were induced 8 weeks prior to the start of the study. Seven female DL-AAA rabbits received one implant in the OD (left eye) and one placebo implant in the OS (right eye), while three rabbits received two implants in the OU (both eyes). Eyes were monitored on day 1, day 8, and monthly thereafter using fluorescein angiography (FA), auxiliary angle (55°) infrared imaging, and slit-lamp ophthalmology (including McDonald-Shadduck score) for 12 months. To assess tolerability, three untreated female Dutch rabbits received one implant in the OD and a sham injection in the OS, while three rabbits received two implants in the OD and two placebo implants in the OS. Plasma was collected to monitor systemic drug exposure.

[0131] Compared to placebo, administration of one or two implants, starting on day 8 and continuing for 12 months, showed inhibition of retinal vascular leakage on fluorescein angiography. Both one and two implants provided the greatest inhibition of vascular leakage. Observations consistent with intravitreal injection were observed, with complete symptom resolution. Systemic exposure was minimal, with values ​​close to or below the lower limit of quantitation. Preliminary signs of implant biodegradation were observed starting on day 210. Therefore, long-acting implants can provide a long-term treatment alternative for wAMD, RVO, and / or DME.

[0132] In some embodiments, the implant described herein comprises an MKI and a polymer, such as poly(D,L-lactic acid) (PLA), poly(D,L-lactic acid-co-glycolic acid) (PLGA), or a combination thereof.

[0133] The implant can remain in the eye for six months or longer. The insertion device 100 can accommodate implants of various sizes and shapes. In one example, the size of the implant is controlled relative to the pusher wire 150 to prevent air bubbles from forming during implant delivery. In one example, the implant or pusher wire 150 may include a pattern or surface treatment configured to prevent the pusher wire 150 from adhering to the implant during implant insertion. The pattern or surface treatment can be obtained through laser processing, conventional processing, surface texturing methods, electrical discharge machining (EDM) methods, or any suitable additive method.

[0134] The implant can be any suitable shape, such as a cylinder. In some embodiments, the implant may include a rod, tube, or a modified rod design with a custom shape to ensure proper drug interactions. The implant can be any suitable size. For example, the implant has an outer diameter of approximately 0.35 mm and a length of approximately 6 mm.

[0135] One embodiment includes a method of delivering an implant into an eye. The method includes inserting a needle 180 of any of the examples described herein (i.e., 100, 200, 400, 500) into the eye. In some embodiments, a surgeon inserts the needle 180 into the posterior chamber of the eye. The method may also include pressing a button 140 to deliver an implant 200 into the eye. In some examples, the method includes repositioning the insertion device 100 after delivering a first implant 300a into the eye. The method also includes pressing the button 140 a second time to deliver a second implant 300b into the same eye or a different eye. In some examples, the method includes removing the inserter tip 120 from the body 110 after use, resetting the internal components of the body 110, and attaching a different inserter tip 120 to the body 110 for reuse. In one example, the method also includes attaching the inserter tip 120 to the body 110 before inserting the needle 180 into the eye. In one example, the method includes loading the insertion device 100 with an implant. In one example, the method includes a method of treating an eye disease.

[0136] The above description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples that provide only those elements shown or described. Furthermore, the inventors also contemplate examples of any combination or arrangement of those elements (or one or more aspects thereof) shown or described, whether relating to a particular example (or one or more aspects thereof) or other examples (or one or more aspects thereof) shown or described herein.

[0137] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0138] In this document, the use of the terms “a” or “an,” as is common in patent documents, includes one or more, independent of any other instance or use of “at least one” or “one or more.” In this document, the term “or” is used to mean a non-exclusive “or,” such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise stated. In this document, the terms “comprising” and “wherein” are used as their common English equivalents to the respective terms “including” and “wherein.” Furthermore, in the following claims, the terms “comprising” and “including” are open-ended, meaning that any system, device, article, composition, formulation, or method that includes elements other than those listed after the term is still considered to fall within the scope of the claim. Additionally, in the following claims, the terms “first,” “second,” and “third,” etc., are used merely as labels and are not intended to impose numerical requirements on their objects.

[0139] Geometric terms such as “parallel,” “perpendicular,” “circular,” or “square” do not require absolute mathematical precision unless the context otherwise specifies. Instead, such geometric terms allow for variation due to manufacturing or equivalent functions. For example, if an element is described as “circular” or “approximately circular,” parts that are not exactly circular (e.g., slightly elliptical or polygonal) are still included in the description.

[0140] The above description is intended to be illustrative and not restrictive. For example, the examples above (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, for example, those of ordinary skill in the art who will be able to use them after reading the above description. An abstract is provided to conform to 37 CFR §1.72(b) to enable the reader to quickly determine the nature of the technical disclosure. It is understood that the abstract is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined together to simplify the disclosure. This should not be construed as an intention to make any unclaimed disclosed feature essential to any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the following claims are incorporated into the detailed description as examples or embodiments, each claim being an independent, separate embodiment, and these embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

Claims

1. An insertion device for injecting an implant into the eye, the insertion device comprising: The main body includes: The button includes a button portion, a first spring, and an arm extending from the button portion, wherein the first spring biases the arm and the button portion in an upward position. Wire pushing, and The actuating mechanism includes a shuttle and a second spring. The pusher wire includes a first end and a second end, wherein the second end of the pusher wire is coupled to the sliding shuttle; and An inserter tip, the inserter tip including a needle, wherein the inserter tip is detachably coupled to the body. When the button is pressed, the pushing mechanism is configured to move the push wire so that a portion of the push wire is translated through the needle.

2. The insertion device according to claim 1, wherein, The pusher wire moves through the needle at a uniform speed, wherein the uniform speed is independent of the force applied to the button by pressing the button.

3. The insertion device according to claim 1, wherein, The main body also includes a main trunk, wherein the button and the actuation mechanism are integrated with the main trunk.

4. The insertion device according to claim 1, wherein, The shuttle includes a first groove and a second groove, wherein the first groove and the second groove are configured as part of an arm that receives the button.

5. The insertion device according to claim 4, wherein, The insertion device includes a first non-triggered state, a first triggered state, and a second non-triggered state. In the first non-triggered state, the portion of the arm is located in the first groove. In the first triggered state, the portion of the arm is disengaged from the first groove. In the second non-triggered state, the portion of the arm is located in the second groove.

6. The insertion device according to claim 1, further comprising: Retaining components; as well as An implant placed within the needle. The retaining member applies force to the implant to hold the implant in place within the needle.

7. The insertion device according to claim 6, wherein, Pressing the button causes the portion of the push wire to translate through the needle and abut against the implant, wherein the force applied from the push wire to the implant is greater than the force from the retaining member, thereby causing the implant to eject from the needle.

8. The insertion system according to claim 6, wherein, The implant includes medication for delivery to the eye.

9. An insertable end configured to be detachably coupled to an insertable device for injecting an implant into an eye, the insertable end comprising: Needle; as well as A cap for receiving the needle. The cover includes one or more grooves. Wherein, the one or more grooves include a notch located on a side surface of the groove, and The one or more grooves are configured to secure the insertion end to the insertion device.

10. The insertion end according to claim 9, wherein, The needle includes a double-beveled edge.

11. The insertion end according to claim 9, wherein, The inserter tip includes the implant configured for injection into the eye.

12. The insertion end according to claim 11, wherein, The implant is placed inside the needle.

13. The insertion end of claim 12, further comprising a retaining member configured to apply force to the implant to abut against the inner surface of the needle.

14. The insertion end according to claim 13, wherein, The retaining member includes a distal portion, a proximal portion, and an elongated member located between the distal portion and the proximal portion, wherein the distal portion is configured to apply force to the implant to abut against the inner surface of the needle.

15. The insertion end according to claim 14, wherein, The proximal portion of the retaining member is configured to anchor the retaining member to the needle, wherein the elongated member is disposed within the needle.

16. The insertion end according to claim 11, wherein, The implant is a first implant, and the insertion end further includes a second implant.

17. The insertion device according to claim 16, wherein, The first implant and the second implant are arranged in a string inside the needle.

18. A method of inserting an implant into an eye, the method comprising: Inserting a needle of an insertion device into the eye, wherein the insertion device includes a body detachably coupled to an insertion tip, wherein the body includes a button, a pusher, and a pushing mechanism, and wherein the insertion tip includes a needle; and Press the button on the insertion device to deliver the implant into the eye at a consistent speed through the needle at the insertion end.

19. The method of claim 18, further comprising loading the implant onto the distal end of the insertion device prior to inserting the needle into the eye.

20. The method of claim 18, further comprising securing the insertion end to the body prior to inserting the needle of the insertion device.

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