Systems, devices and methods for delivering an implant

Abstract

Systems and methods for delivering an implant to treat an ocular disorder is disclosed. The ocular implant can include a treatment fluid that is released over the course of several days or months to treat an ocular disorder. A system for implanting and retrieving spent implants can include an implant, an external housing, and an implant assembly. The external housing can provide access to a sliding trigger. The sliding trigger can convert a portion of the implant assembly from a first configuration to a second configuration and a second configuration to a third configuration to release or retrieve an implant. In some embodiments, the implant assembly can include a collet formed from sheet metal and bent to act as a spring. The collet can have protrusions to match the profile of an implant to secure the implant during delivery. Actuation of the trigger can relieve the spring's pressure.

Description

SYSTEMS, DEVICES AND METHODS FOR DELIVERING AN IMPLANTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Nos. 63 / 549765 filed February 5, 2024 and 63 / 558574 filed February 27. 2024, each of which is hereby incorporated by reference in its entirety and made part of this specification for all that it discloses.FIELD

[0002] Embodiments described herein generally relate to devices and methods for delivering an implant (e.g., an intraocular implant within the eye) configured to release a treatment fluid and optionally retrieving a different implant that has spent its treatment fluid without having to remove the implant deliver}' apparatus from a body of the subject between implantation and retrieval.BACKGROUND

[0003] A human eye is a specialized sensory' organ capable of light reception and is able to receive visual images. Aqueous humor (hereinafter referred to as "aqueous") is a transparent liquid that fills at least the region between the cornea, at the front of the eye, and the lens. Aqueous is continuously secreted by ciliary processes of a ciliary body to the posterior chamber of the eye and the aqueous flows to the anterior chamber by crossing the pupil, so there is a constant flow of aqueous humor from the ciliary' body to the anterior chamber of the eye. The aqueous fluid supplies nutrients to the avascular structures of the eye (for example, the cornea and the lens) and maintains intraocular pressure. Pressure within the eye is determined by a balance between the production of aqueous and its exit through canalicular outflow, uveoscleral outflow, or other outflow routes or pathways.

[0004] Many open-angle glaucomas are caused by an increase in the resistance to aqueous drainage through the trabecular meshwork and / or Schlemm’s canal (e.g., the canalicular outflow pathways). The tissue of the trabecular meshwork normally allows the aqueous to enter Schlemm’s canal, which then empties into aqueous collector channels in the posterior wall of Schlemm’s canal and then into aqueous veins, which form the episcleral venous system. The uveoscleral outflow pathways can refer to the aqueousleaving the anterior chamber by diffusion through intercellular spaces among ciliary muscle fibers or through a supraciliary and / or suprachoroidal space.SUMMARY

[0005] Intraocular implants can be implanted within the eye to provide time- released treatment fluids to the eye as part of a proscribed treatment plan. Typical methods of implantation require relatively invasive surgical procedures, pose a risk of excessive trauma to the eye, and require excessive handling of the implant. For example, in a typical method of implantation, an incision would be made into the eye, and a surgical tool would either be inserted into the incision or the incision would be widened to accommodate the implant end of the tool, which could cause further trauma to the eye. Advantageously, a surgical procedure and tool as outlined herein could avoid some or all of these issues.

[0006] In some aspects, the techniques described herein relate to an implant insertion apparatus configured to deliver an implant for treating an ocular disorder, the apparatus including: an external housing including an opening on an upper side of the external housing; an implant insertion assembly configured to provide an implant to an implant location in an eye of a patient, the implant insertion assembly including a sliding trigger partially protruding through the external housing through the opening, a trigger spring, a backing member, and a tube set assembly; wherein the backing member includes a collet on a distal end of the backing member, the collet configured to retain an implant, and an introducer tube, the introducer tube configured to at least partially house the collet when in a first configuration; wherein the collet includes one or more collet arms with griping areas configured to retain the implant; wherein the backing member and the collet are slidably attached to the backing member, wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction moves the introducer tube in the first direction; wherein moving the sliding trigger in the first direction changes the tube set assembly from a first configuration to a second configuration; wherein moving the sliding trigger further in the first direction changes the tube set assembly from the second configuration to a third configuration; wherein the trigger spring provides a feedback to a user as the sliding trigger moves from the first configuration to the second configuration; wherein in the first configuration the collet retains the implant and substantially all of the implant is within the introducer tube; wherein in the second configuration the collet retains the implant and the implant is partially disposed beyond a distal end of the introducer tube; wherein in the third configuration theimplant is released from the collet and the implant is free from the implant insertion apparatus.

[0007] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein moving the sliding trigger in a second direction substantially opposite the first direction changes the tube set assembly from the third configuration to a fourth configuration; and wherein in the fourth configuration the collet is closed and at least partially within the introducer tube

[0008] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein protrusions on the collet substantially prevent movement of the implant in the first direction when in the first configuration and the second configuration.

[0009] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein protrusions on the collet substantially prevent movement of the implant in the second direction when in the first configuration and the second configuration.

[0010] In some aspects, the techniques described herein relate to an implant insertion apparatus, further including a trigger lock which prevents movement of the sliding trigger in the first direction, wherein the trigger lock is configured to be removable from the implant insertion apparatus.

[0011] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the tube set assembly is at an angle relative to a longitudinal axis of the implant insertion apparatus.

[0012] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the implant further includes a main body with a distal end and a proximal end, the distal end including an implant connection end, the implant connection end including a sharpened end configured to enter into a sclera of the eye adjacent to a Schlemm's canal and a retaining portion configured to maintain the implant at the implant location, the main body including a reservoir configured to contain a specific amount of a treatment fluid.

[0013] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein a portion of the tube set assembly is dimensioned to pass through a 1 mm incision into an eye.

[0014] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the trigger spring is configured to bias the tube set assembly to the first configuration.

[0015] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the feedback is a physical or auditory' feedback.

[0016] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the feedback is a resistance felt by the user.

[0017] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein an outer surface of the introducer tube further includes one or more surface features configured to reduce friction between the introducer tube and the eye.

[0018] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the one or more surface features include recesses running along at least a portion of the introducer tube.

[0019] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the one or more surface features are angled along a length of the introducer tube.

[0020] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the one or more surface features includes a pattern selected from the group including: irregular patterns along the introducer tube, writing, geometric shapes, non-linear arcs, or other patterns.

[0021] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein a portion of the tube set assembly is configured to pierce a cornea of the eye.

[0022] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein a distal end of the introducer tube further includes a protrusion configured to direct the pierced cornea aw ay from the distal end of the introducer tube.

[0023] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein a distal end of the introducer tube further includes a protrusion configured to retain the implant during deployment.

[0024] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the introducer tube further includes a curved distal portion configured to facilitate entry into an incision of the eye.

[0025] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the collet includes two or more collet parts, wherein the two or more collet parts are connected to the backing rod.

[0026] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein each of the collet parts is bent with a first bend and a second bend, the first bend and the second bend being in substantially opposite directions; wherein each of the collet parts retain the implant when in the first configuration by the first bend and the second bend pressing the collet parts into an inner surface of the introducer tube; and wherein each of the collet parts retain the implant when in the second configuration by the second bend pressing the collet parts into the inner surface of the introducer tube.

[0027] In some aspects, the techniques described herein relate to an implant insertion apparatus configured to deliver and / or retrieve an implant for treating an ocular disorder, the apparatus including: an external housing including an opening on an upper side of the external housing; an implant insertion assembly configured to facilitate introduction of a distal portion of the implant insertion apparatus into an implant location in an eye of a patient, the implant insertion assembly including a sliding trigger partially protruding through the external housing through the opening, a trigger spring, and a tube set assembly; wherein the tube set assembly includes a backing rod with a collet on a distal end of the backing rod, the collet configured to retain an implant, and an introducer tube, the introducer tube configured to restrain the collet when in a first configuration; wherein the collet includes one or more collet arms with collet protrusions configured to interface with a collet interface portion of the implant; wherein the backing rod and the collet are fixedly attached to the external housing by a collet holder assembly, wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction moves the introducer tube in the first direction; wherein moving the sliding trigger in the first direction changes the tube set assembly from a first configuration to a second configuration; wherein moving the sliding trigger further in the first direction changes the tube set assembly from the second configuration to a third configuration; wherein the trigger spring provides a feedback to a user when the sliding trigger moves from the first configuration to the second configuration and prevents the sliding trigger from substantially moving beyond the third configuration; wherein in the first configuration the collet is closed around the implant and substantially all of the implant is within the introducer tube; wherein in the second configuration the collet is closed around the implant and implant is partially disposed beyond a distal end of the introducer tube; and wherein inthe third configuration the collet is opened and the implant is free from the implant insertion apparatus.

[0028] In some aspects, the techniques described herein relate to an implant insertion apparatus, wherein the collet protrusions substantially prevent movement of the implant in the first direction when in the first configuration and the second configuration.

[0029] In some aspects, the techniques described herein relate to the implant insertion apparatus further including a trigger lock which prevents movement of the sliding trigger in the first direction, wherein the trigger lock is configured to be removable from the implant insertion apparatus.

[0030] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the implant further includes a main body with a distal end and a proximal end, the distal end including an implant connection end, the implant connection end including a sharpened end configured to enter into a sclera of the eye adjacent to a Schlemm's canal and a retaining portion configured to maintain the implant at the implant location, the main body including a reservoir configured to contain a specific amount of a treatment fluid.

[0031] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein a portion of the tube set assembly is dimensioned to pass through a 1 mm incision into an eye.

[0032] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the trigger spring is configured to bias the tube set assembly to the first configuration.

[0033] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the feedback is a physical or auditory feedback.

[0034] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the feedback is a resistance felt by the user.

[0035] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the introducer tube further includes a curved distal portion configured to facilitate entry into an incision of an eye.

[0036] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the collet is formed as a unitary' body.

[0037] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the collet includes two or more parts.

[0038] In some aspects, the techniques described herein relate to the implant insertion apparatus wherein the collet is formed from sheet metal.

[0039] In some aspects, the techniques described herein relate to a method of treating an ocular disorder, including: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus including: an implant assembly including a sliding trigger and a tube set assembly, the tube set assembly including a backing rod with a collet containing an implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to a third configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at an implant location; advancing the implant assembly such that a distal end of the implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; and. partially withdrawing the implant insertion apparatus from the implant location.

[0040] In some aspects, the techniques described herein relate to a method, further including positioning the distal end of the implant assembly at a second implant location with a second implant; advancing the implant assembly such that the distal end of the implant assembly would partially surround the second implant; converting the implant insertion apparatus from the third configuration to the second configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the second configuration to the first configuration; and removing the implant insertion apparatus from the eye.

[0041] In some aspects, the techniques described herein relate to a method, further including confirming attachment of the implant to the implant location by tapping the implant wi th the distal end of the implant assembly.

[0042] In some aspects, the techniques described herein relate to a method, further including: partially withdrawing the distal end of the implant assembly from the implant location; converting the implant insertion apparatus from the third configuration to the second configuration, and from the second configuration to the first configuration; and withdrawing the implant insertion apparatus from the incision in the eye.

[0043] In some aspects, the techniques described herein relate to a method, wherein the method does not require use of viscoelastic.

[0044] In some aspects, the techniques described herein relate to a method, further including applying viscoelastic into the eye.

[0045] In some aspects, the techniques described herein relate to a method of removing an implant from an eye, including: positioning at least a portion of an implant insertion apparatus when in a third configuration adjacent an implant at an implant location within an eye, the implant insertion apparatus including: an implant assembly including a sliding trigger and a tube set assembly, the tube set assembly including a backing rod with a collet containing an implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to the third configuration; abutting the backing rod against the implant; converting the implant insertion apparatus from the third configuration to a fourth configuration by moving the sliding trigger in a second direction substantially opposite the first direction; partially withdrawing the implant insertion apparatus from the implant location, wherein the implant has been removed from the implant location; and converting the implant insertion apparatus from the fourth configuration to the first configuration by moving the sliding trigger in the second direction.

[0046] In some aspects, the techniques described herein relate to a method of treating an ocular disorder, including: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus including: an implant assembly including a sliding trigger and a tube set assembly, the tube set assembly including a backing rod with a collet containing a first implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and moving the sliding trigger in a second direction converts the implant insertion apparatus from the second configuration to a third configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at a first implant location; advancing the implant assembly such that a distal end of the first implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; partially withdrawing the implant insertion apparatus from the first implant location; advancing the implantassembly such that the distal end of the implant assembly would partially surround a second implant, wherein the second implant is implanted at a second implant location; converting the implant insertion apparatus from the third configuration to the second configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the second configuration to the first configuration; and removing the implant insertion apparatus from the eye.

[0047] In some aspects, the techniques described herein relate to a method of treating an ocular disorder, including: advancing at least a portion of an implant insertion apparatus through an incision in an eye. the implant insertion apparatus including: an implant assembly including a sliding trigger and a tube set assembly, the tube set assembly including a backing rod with a collet containing a first implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to a third configuration and moving the sliding trigger in a second direction converts the implant insertion apparatus from the third configuration to a fourth configuration and from the fourth configuration to the first configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at a first implant location; advancing the implant assembly such that a distal end of the first implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; partially withdrawing the implant insertion apparatus from the first implant location; advancing the implant assembly such that the distal end of the implant assembly would partially surround a second implant, wherein the second implant is implanted at a second implant location; converting the implant insertion apparatus from the third configuration to the fourth configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the fourth configuration to the first configuration; and removing the implant insertion apparatus from the eye.BRIEF DESCRIPTION OF THE DRAWINGS

[0048] These and other features, aspects, and advantages of the present disclosure will now be described with reference to the drawings of various embodiments, which embodiments are intended to illustrate and not to limit the scope of the disclosure.

[0049] Figure 1A is a schematic cross-sectional view of an eye.

[0050] Figure IB is an enlarged cross-sectional view of an anterior chamber angle of the eye of Figure 1A.

[0051] Figure 2A is a perspective view illustrating an embodiment of an implant insertion apparatus.

[0052] Figure 2B is a rear view illustrating an embodiment of the implant insertion apparatus of Figure 2 A.

[0053] Figure 2C is a front view illustrating an embodiment of the implant insertion apparatus of Figure 2 A.

[0054] Figure 2D is a side view illustrating an embodiment of the implant insertion apparatus of Figure 2 A.

[0055] Figure 2E is another side view illustrating an embodiment of the implant insertion apparatus of Figure 2 A.

[0056] Figure 2F is a top view illustrating an embodiment of the implant insertion apparatus of Figure 2A.

[0057] Figure 2G is a bottom view illustrating an embodiment of the implant insertion apparatus of Figure 2A.

[0058] Figure 3 is a perspective exploded view of the implant insertion apparatus of Figure 2A.

[0059] Figure 4A is a side perspective view of an embodiment of a left housing of the implant insertion apparatus of Figure 2A.

[0060] Figure 4B is a side perspective view of an embodiment of a right housing of the implant insertion apparatus of Figure 2A.

[0061] Figure 5A is a right side view of an embodiment of the internal components of the implant insertion apparatus of Figure 2A.

[0062] Figure 5B is a left side view of the embodiment of the internal components of Figure 5 A.

[0063] Figure 6A is a left side view of an embodiment of the internal components and a portion of a left housing of the implant insertion apparatus of Figure 2A in a first configuration.

[0064] Figure 6B is a left side view of an embodiment of the internal components and a portion of a left housing of the implant insertion apparatus of Figure 2A in a second configuration.

[0065] Figure 6C is a left side view of an embodiment of the internal components and a portion of a left housing of the implant insertion apparatus of Figure 2A in a third configuration.

[0066] Figure 7 is a top view of the distal end of the implant insertion apparatus of Figure 2A.

[0067] Figure 8A is a right side perspective view of an embodiment of an implant compatible with the implant insertion apparatus of Figure 2A.

[0068] Figure 8B is a side view illustrating the implant of Figure 8A compatible with the implant insertion apparatus of Figure 2 A.

[0069] Figure 8C is a side cross-sectional view illustrating the implant of Figure 8 A compatible with the implant insertion apparatus of Figure 2 A.

[0070] Figure 8D is a side view illustrating the implant of Figure 8A compatible with the implant insertion apparatus of Figure 2 A.

[0071] Figure 8E is a right side perspective deconstructed view illustrating the implant of Figure 8A compatible with the implant insertion apparatus of Figure 2A

[0072] Figure 9A is a side perspective view of the distal end of the implant insertion apparatus of Figure 2A in a first configuration.

[0073] Figure 9B is a top view of the distal end of the implant insertion apparatus of Figure 2A in a first configuration.

[0074] Figure 10A is a side perspective view of the distal end of the implant insertion apparatus of Figure 2A in a second configuration.

[0075] Figure 10B is a top view of the distal end of the implant insertion apparatus of Figure 2A in a second configuration.

[0076] Figure 11A is a side perspective view of the distal end of the implant insertion apparatus of Figure 2A between a second configuration and a third configuration.

[0077] Figure 11 B is a top view of the distal end of the implant insertion apparatus of Figure 2A between a second configuration and a third configuration.

[0078] Figure 12A is a side perspective view of the distal end of the implant insertion apparatus of Figure 2A in a third configuration.

[0079] Figure 12B is a top view of the distal end of the implant insertion apparatus of Figure 2A in a third configuration.

[0080] Figure 13 A is an example method of using the implant insertion apparatus to insert an implant.

[0081] Figure 13B is an example method of using the implant insertion apparatus to retrieve or remove an implant.

[0082] Figure 13C is an example method of using the implant insertion apparatus to insert a first implant and to retrieve or remove a second implant.

[0083] Figure 14A is a perspective view illustrating an embodiment of an implant insertion apparatus.

[0084] Figure 14B illustrates an embodiment of a trigger of the implant insertion apparatus of Figure 14A.

[0085] Figure 14C is a right side view of an embodiment of the internal components and a portion of a right housing of the implant insertion apparatus of Figure 14A in a first configuration.

[0086] Figure 14D is a right side view of an embodiment of the internal components and a portion of a right housing of the implant insertion apparatus of Figure 14A in a second configuration.

[0087] Figure 14E is a right side view of an embodiment of the internal components and a portion of a right housing of the implant insertion apparatus of Figure 14A in a third configuration.

[0088] Figure 15A is a right side view of an embodiment of the internal components of the implant insertion apparatus of Figure 14A.

[0089] Figure 15B illustrates a partially transparent perspective view of an embodiment of a collet holder assembly and collet holder key.

[0090] Figure 15C illustrates a cross-sectional view of an embodiment of a collet holder assembly and collet holder key.

[0091] Figure 16A illustrates an embodiment of a collet attached to a backing rod.

[0092] Figure 16B illustrates an embodiment of a collet.

[0093] Figure 16C illustrates an embodiment of a collet comprising two collet halves attached to a backing rod.

[0094] Figure 16D illustrates an embodiment of a collet half of the collet of Figure 16C.

[0095] Figure 16E illustrates a top view of the distal end of an embodiment of the implant insertion apparatus.

[0096] Figure 16F illustrates a cross-sectional top view of the distal end of an embodiment of the implant insertion apparatus.

[0097] Figure 17A illustrates an embodiment of a collet comprising two collect halves attached to a backing rod.

[0098] Figure 17B illustrates an embodiment of one collet half of the collet of Figure 17 A.

[0099] Figure 17C illustrates an embodiment of one collet half of the collet of Figure 17 A.

[0100] Figure 18A is a perspective view illustrating an embodiment of an implant insertion apparatus.

[0101] Figure 18B is a front view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0102] Figure 18C is a rear view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0103] Figure 18D is a side view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0104] Figure 18E is another side view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0105] Figure 18F is a top view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0106] Figure 18G is a bottom view illustrating an embodiment of the implant insertion apparatus of Figure 18 A.

[0107] Figure 19 is a perspective exploded view of the implant insertion apparatus of Figure 18 A.

[0108] Figure 20 is a right side view of an embodiment of the internal components of the implant insertion apparatus of Figure 18A.

[0109] Figure 21 is a left side view of the embodiment of the internal components of Figure 20.

[0110] Figure 22A is a right side view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a first configuration.

[0111] Figure 22B is a right cross-sectional view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a first configuration.

[0112] Figure 22C is a side perspective view of an introducer tube of the implant insertion apparatus of Figure 18A when in a first configuration.

[0113] Figure 23 A is a right side view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a second configuration.

[0114] Figure 23B is a right cross-sectional view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a second configuration.

[0115] Figure 23C is a side perspective view of an introducer tube of the implant insertion apparatus of Figure 18A when in a second configuration.

[0116] Figure 24A is a right side view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a third configuration.

[0117] Figure 24B is a right cross-sectional view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a third configuration.

[0118] Figure 24C is a side perspective view of an introducer tube of the implant insertion apparatus of Figure 18A when in a third configuration.

[0119] Figure 25 A is a right side view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a fourth configuration.

[0120] Figure 25B is a right cross-sectional view of the internal components arranged within the implant insertion apparatus of Figure 18A when in a fourth configuration.

[0121] Figure 25C is a side perspective view of an introducer tube of the implant insertion apparatus of Figure 18A when in a fourth configuration.

[0122] Figure 26A is a side perspective view of an introducer tube with a surface feature according to one embodiment.

[0123] Figure 26B is a side perspective view of an introducer tube with a surface feature according to one embodiment.

[0124] Figure 27A is a side perspective view of an introducer tube with a distal tip profile according to one embodiment.

[0125] Figure 27B is a side perspective view of an introducer tube with a distal tip profile according to one embodiment.

[0126] Figure 27C is a side perspective view of an introducer tube with a distal tip profile according to one embodiment.

[0127] Figure 27D is a side perspective view of an introducer tube with a distal tip profile according to one embodiment.

[0128] Figure 28 is a side perspective view of an introducer tube with a sharpened distal end and implant retention feature according to one embodiment.DETAILED DESCRIPTIONI. Introduction

[0129] Disclosed herein are several versions of a surgical tool and related procedure designed to reduce the trauma associated with implanting or removing an implant. The system can be designed to be especially suited for an ocular implant, but can also be used in other procedures not related to the eye. The system can include a main body with a trigger that a doctor or other user can easily and comfortably manipulate with one hand during an implant procedure. The system can include a nested series of tubes which have dimensions and features designed to retain and position an implant for a procedure. The outermost introducer tube can advantageously allow for easy insertion of the implant portion through surrounding tissue, while also providing protection to surrounding tissue from the implant and tube set, and protection to the implant from the surrounding tissue.

[0130] During a procedure, the user or operator can position the system within the surgical area, such as the eye, and deploy an implant that has been anchored into an implant area by using the trigger. The trigger can have force-feedback systems designed to notify (e.g., provide tactile and / or audible feedback to) the user or operator when the device is in one of several positions, such as when the implant is ready to implant where an anchoring part of the implant is exposed while still being firmly retained by the system. The trigger can be connected to one or more of the tubes so that, as the user slides or otherwise uses the trigger, one or more of the tubes retracts. Some of the tubes can be spring-like and want to return to an expanded state with a profile that is larger than before the trigger is used. This expansion can release the implant. The system or insertion device can also be used to capture an implant and remove it from the eye in the same delivery procedure without having to remove the system or insertion device from the eye.

[0131] In accordance with several embodiments, the systems and devices described herein could increase comfort with in-office procedures, as the reduced tube sizes and protection to the implant and surrounding tissue due to protective nature of the nested tube design reduces the need for large incisions or the use of supplementary' surgical procedures, such as the insertion of viscoelastic.

[0132] Embodiments of systems, devices and methods for delivering and / or retrieving one or more ocular implants of various shapes and sizes are described herein. Inthe following description, numerous specific details are set forth to provide a thorough understanding of the embodiments; however, one skilled in the relevant art will recognize, based upon the disclosure herein, that the techniques described herein can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring certain aspects.

[0133] Reference throughout this description to “one embodiment7’ or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment described herein. Thus, the appearances of the phrases “in one embodiment” or “in certain embodiments” in various places throughout this description are not necessarily all referring to the same embodiments. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0134] Figure 1A is a cross-sectional view of an eye 100. Figure IB is an enlarged sectional view of the eye showing the relative anatomical locations of a trabecular meshwork 121, an anterior chamber 120. and Schlemm’s canal 122. With reference to Figures 1A and IB, the sclera 11 1 is a thick collagenous tissue that covers the entire eye 100 except a portion that is covered by a cornea 112. The cornea 112 is a thin transparent tissue that focuses and transmits light into the eye and through a pupil 114, which is a circular hole in the center of an iris 113 (colored portion of the eye). The cornea 112 merges into the sclera 1 1 1 at a juncture referred to as a limbus 1 15. A ciliary body 1 16 is vascular tissue that extends along the interior of the sclera 111 from the outer edges of the iris in the limbal region to a choroid 117. The ciliary body 116 is comprised of ciliary processes and ciliary muscle. Ciliary zonules extend from the ciliary processes to a lens 126. The choroid 117 is a vascular layer of the eye 100, located between the sclera 111 and a retina 118. An optic nerve 1 19 transmits visual information to the brain and is the anatomic structure that is progressively destroyed by glaucoma.

[0135] With continued reference to Figures 1A and IB, the anterior chamber 120 of the eye 100. which is bound anteriorly by the cornea 112 and posteriorly by the iris 1 13 and the lens 126, is filled with aqueous humor. Aqueous humor is produced primarily by the ciliary processes of the ciliary body 116 and flow's into the posterior chamber, bounded posteriorly by the lens 126 and ciliary' zonules and anteriorly by the iris 113. The aqueous humor then flows anteriorly through the pupil 114 and into the anterior chamber120 until it reaches an anterior chamber angle 125, formed between the iris 113 and the cornea 112.

[0136] As best illustrated by the drawing of Figure IB, in a normal eye, at least some of the aqueous humor drains from the anterior chamber 120 through the trabecular meshwork 121 via the canalicular route. Aqueous humor passes through the trabecular meshwork 121 into S chi emm's canal 122 and thereafter through a plurality of collector ducts and aqueous veins 123, which merge with blood-carrying veins, and into systemic venous circulation. Intraocular pressure is maintained by an intricate balance between secretion and outflow of aqueous humor in the manner described above. Glaucoma is, in most cases, characterized by an increased outflow resistance of aqueous humor from the anterior chamber 120. which leads to an increase in intraocular pressure. Fluids are relatively incompressible, and thus intraocular pressure is distributed relatively uniformly throughout the eye 100.

[0137] As shown in Figure IB, the trabecular meshwork 121 lies adjacent a small portion of the sclera 111. Exterior to the sclera 111 is a conjunctiva 124. Traditional procedures that create a hole or opening for implanting a device through the tissues of the conjunctiva 124 and sclera 111 involve extensive surgery, as compared to surgery for implanting a device, such as described herein, which ultimately resides entirely within the confines of the sclera 111 and cornea 112.

[0138] In accordance with some embodiments, an ophthalmic implant system is provided that comprises an ocular implant and a delivery instrument for delivering and implanting and / or retrieving an ocular implant within eye tissue. The implant may be preloaded within the delivery instrument at the time of assembly, manufacture or packaging. The ocular implant can be configured to provide a time-released treatment fluid to the eye at an implant location, such as along Schl emm’s canal, within the sclera, aqueous collector channels, episcleral veins, the uveoscleral outflow pathway, the supraciliary space, and / or the suprachoroidal space. The physiologic outflow pathway can be an existing space or outflow pathway (such as Schl emm’s canal) or a potential space or outflow pathway (such as the suprachoroidal space). While this and other systems and associated methods and apparatuses may be described herein in connection with glaucoma treatment (e.g., phakic or pseudophakic mild to moderate or refractory open angle glaucoma), the disclosed systems, methods, and apparatuses can be used to treat other types of ocular disorders in addition to glaucoma or to implant other devices (such as pressure sensors or analyte sensors (e.g., glucose sensors)).

[0139] While a majority of the aqueous leaves the eye through the trabecular meshwork and Schlemm's canal, it is believed that a significant percentage of the aqueous in humans leaves through the uveoscleral pathway. The degree with which uveoscleral outflow contributes to the total outflow of the eye appears to be species dependent. As used herein, the term “uveoscleral outflow pathway” is to be given its ordinary' and customary meaning to a person of ordinary skill in the art (and it is not to be limited to a special or customized meaning), and refers without limitation to the space or passageway whereby aqueous exits the eye by passing through the ciliary muscle bundles located at or near an angle of the anterior chamber and into the tissue planes between the choroid and the sclera, which extend posteriorly to the optic nerve. From these tissue planes, it is believed that the aqueous travels through the surrounding scleral tissue and drains via the scleral and conjunctival vessels, or is absorbed by the uveal blood vessels.

[0140] As used herein, the term “supraciliary space” is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and it is not to be limited to a special or customized meaning), and refers without limitation to the portion of the uveoscleral pathway through the ciliary muscle and between the ciliary body and the sclera, and the term “suprachoroidal space” is to be given its ordinary and customary meaning to a person of ordinary' skill in the art (and it is not to be limited to a special or customized meaning), and refers without limitation to the portion of the uveoscleral pathway between the choroid and sclera.

[0141] The following description will include references to distal and proximal ends of various components and right and left sides of various components. The terms “distal” and “proximal” are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to opposite regions or ends of a particular structure. In some embodiments, the term “distal” is used to refer to a region or end farther away from a person using the systems and devices described herein or performing the methods described herein and the term “proximal” is used to refer to a region or end closer to the person using the systems and devices described herein or performing the methods described herein; however, the meanings of the terms can be swapped.

[0142] The term “right side” should be understood to mean the side of the component that, upon assembly, faces the right housing of the multiple-implant delivery apparatus and the term “left side” should be understood to mean the side of the component that, upon assembly, faces the left housing of the multiple-implant delivery apparatus.However, these terms, as well as terms of orientation such as “top;’ “bottom,’" “upper,” “lower.” “front,” “rear.” and “end” are used herein to simplify the description of the context of the illustrated embodiments. Likewise, terms of sequence, such as "‘first” and “second,” are used to simplify the description of the illustrated embodiments. Because other orientations and sequences are possible, however, the claims should not be limited to the illustrated orientations or sequences. Those skilled in the art will appreciate, upon reading this disclosure, that other orientations of the various components described above are possible.II. External Components of Multiple-Implant Delivery Apparatus

[0143] Figures 2A - 2G illustrate various views of an embodiment of an implant insertion apparatus 200, as described in the Brief Description of the Drawings section above. The implant insertion apparatus 200 can include an external housing 202. The external housing 202 can include a distal end portion 220 and a proximal end portion 222. The external housing 202 can extend between a distal terminus of the distal end portion 220 and a proximal terminus of the proximal end portion 222. As shown in at least Figure 2A, the proximal end portion 222 of the implant insertion apparatus 200 can be gradually tapered. In some embodiments, the distal end portion 220 is gradually tapered to form a somewhat nose-shaped cone 205. The implant insertion apparatus 200 can include an implant assembly 300 that extends from the cone 205. In some embodiments, the implant insertion apparatus 200 can be used to implant and / or remove an implant from an eye. In some embodiments, the implant insertion apparatus 200 can be used to implant and / or remove an implant from elsewhere in a patient.

[0144] In some embodiments, the implant insertion apparatus 200 includes a forward portion 207 and a rearward portion 206. The rearward portion 206 can include a curved and / or a reduced profile. In some embodiments, an upper portion of the rearward portion 206 of the apparatus 200 is generally rounded towards the proximal end portion 222. In some embodiments, a lower portion of the rearward portion 206 of the apparatus 200 includes a textured portion with a plurality of ridges 218 which can increase the usability of the implant insertion apparatus 200. In some embodiments, the implant insertion apparatus 200 can include one or more feet 224 positioned on the lower side of the implant insertion apparatus 200 such that the implant insertion apparatus 200 can be placed down on a surface without significant rolling of the implant insertion apparatus 200.

[0145] In some embodiments, the external housing 202 includes an opening 212. The opening 212 can provide access to one or more actuators, such as buttons, sliders, and / or levers, among other actuation initiation mechanisms. For example, the delivery apparatus 200 can include a sliding trigger 214 (e.g., an implant delivery actuator, a trigger, an implant actuator, etc.). In some embodiments, at least a portion of the sliding trigger 214 extends through the opening 212. In such configurations, the sliding trigger 214 can be easily manipulated and / or accessible by the user. In some embodiments, the sliding trigger 214 facilitates on-demand manual actuation, which can include the implantation or removal of an implant as explained herein. The sliding trigger 214 interfaces with internal components (not shown) to convert the implant assembly 300 between one of several configurations.

[0146] In some embodiments, actuation of the sliding trigger 214 (e.g., sliding the trigger extending out of the opening 212) in a first direction converts the implant assembly 300 from a first configuration to a second configuration. In some embodiments, further actuation of the sliding trigger 214 can convert the implant assembly 300 from a second configuration to a third configuration. In some embodiments, actuation of the sliding trigger 214 can cause the ejection of an implant 310 from the implant assembly 300 of the implant insertion apparatus 200 and into a desired implant location within the patient's internal eye tissue. In some embodiments, a second actuation may be required to fully release the implant. In some embodiments, the first direction can be a direction substantially towards the user or operator of the implant insertion apparatus 200, such as a proximal direction.

[0147] The implant insertion apparatus 200 can be advantageously ergonomically shaped for easy gripping and manipulation. In some embodiments, the apparatus 200 can include a general overall shape similar to a conventional writing instrument, such as a fountain pen. In some embodiments, the implant insertion apparatus 200 can be grasped by the user between the thumb and the middle finger, with the index finger free to manipulate any portion of the apparatus 200.

[0148] In some embodiments, the lower portion of the delivery apparatus 200 can include a plurality of tactile ridges and / or recesses 218. In some embodiments, the tactile ridges and / or recesses 218 provide a textured surface. In some embodiments, the tactile ridges and / or recesses 218 provide the user with a more stable and / or secure gripping surface to grip the delivery apparatus 200 in use. In some embodiments, the ridges 218 can be located elsewhere along the external housing 202 of the implant insertion apparatus 200.

[0149] In some embodiments, as described in more detail below, the external housing 202 is fabricated from a plurality of separate sections. For example, the external housing 202 can include one or more portions, such as half-sections, that can be coupled through various means, such as a snap-fit or press fit configuration or using an adhesive, or can be unitarily formed, among other arrangements. Although snap-fit or press-fit mechanisms of attachment are generally described herein, these attachment mechanisms (for attachment of housing sections to each other and for attachment of members and components residing within the housing) can be replaced, substituted or enhanced with other attachments methods as desired and / or required (e.g., heat stake, glue or other adhesives, screws, welding, retaining by overhangs, and / or positioned by pressing a feature into plastic (with or without heat)).

[0150] In some embodiments, an ocular implant 310 is pre-loaded within the implant insertion apparatus 200 prior to packaging or delivery at the time of manufacture and assembly. In such embodiments, the implant insertion apparatus 200 can be used to deliver the implant 310 at a desired location within a mammalian (e.g., human) eye. For example, at least a portion of the implant assembly 300 can be advanced through a preformed incision or opening in the eye (e.g., an incision in the cornea or limbus of the eye). In another embodiment, at least a portion of the implant assembly 300 is advanced through external eye tissue (e g., the cornea or limbus), creating an incision or opening through the eye as it is advanced into the eye tissue. As mentioned above, actuation of the sliding trigger 214 can actuate the implant insertion apparatus 200 and cause the ejection of an implant into a desired first location within the patient’s internal eye tissue as the implant insertion apparatus 200 converts from a first configuration to a second configuration to a third configuration. In some embodiments, the implant insertion apparatus 200 can then be repositioned without removing at least the portion of the implant assembly 300 from the incision and remove a second implant that was previously installed at a second location next to or spaced apart from the first location. In some embodiments, the implant assembly 300 can be removed from the incision and reinserted through eye tissue through a separate incision in order to retrieve the second implant from the second implantation site, or to implant a third implant from an implant carrier. In some embodiments, the implant insertion apparatus 200 can be removed from the eye after ejection of the implant at the implant location.III. Internal Operation of Multiple-Implant Delivery Apparatus

[0151] Figure 3 is an exploded perspective view of the implant insertion apparatus 200. The components of the implant insertion apparatus 200 can include a left housing portion 203 A, a right housing portion 203B, the implant assembly 300, and the trigger lock 290.

[0152] As shown, the external housing 202 is formed of two separate halfsections (left and right housing portions 203A, 203B). The left housing portion 203A can include a left section of the opening 212 and the right housing portion 203B can include a right section of the opening 212. In alternative embodiments, the external housing 202 could be separated into top and bottom half-sections instead of right and left half-sections. In yet other alternative embodiments, the external housing 202 is formed of more than two sections configured to be attached together to form a contiguous unit.

[0153] Figure 4A illustrates a side perspective view of the left housing portion 203A and Figure 4B illustrates a side perspective view of the right housing portion 203B. The left housing portion 203A and the right housing portion 203B can be assembled to form a unitary body. The left housing portion 203A and the right housing portion 203B can be coupled through various means, such as a snap-fit or press fit configuration or using an adhesive, or can be unitarily formed, among other arrangements. The left housing portion 203A and / or the right housing portion 203B can include various mating features to couple the left and right housing portions 203 A. 203B and / or features for receiving, supporting and / or aligning the internal components of the implant insertion apparatus 200. For example, the left housing portion 203A can include a rim 240 that protrudes away from the outer surface of the left housing portion 203A and extends along at least a portion of an inner perimeter of the left housing portion 203 A. The rim 240 is configured to couple with a corresponding recess 244 that extends along at least a portion of an inner perimeter of the right housing portion 203B.

[0154] In some embodiments, the left housing portion 203A includes a plurality of snap-fit or press-fit receiving members 242. One or more of the snap-fit or press-fit receiving members 242 can form receptacles that are configured to align with and to receive one or more snap-fit or press-fit engaging members 246 (e.g., flanges, protrusions) that extend from the right housing portion 203B or other component of the implant insertion apparatus 200. One or more of the snap-fit or press-fit receiving members 242 and / or one or more of the snap-fit or press-fit engaging members 246 can be configured to pass through an opening formed in at least one of the internal components of the implant insertionapparatus 200 to support the internal components within the external housing 202. Other configurations are contemplated such as the left housing portion 203 A and / or the right housing portion 203B having one or more of the mating features described above (e.g., the right housing portion 203B can include the snap-fit or press-fit receiving members 242 and the left housing portion 203A can include the snap-fit or press-fit engaging members 246). The left and right housing portions 203 A, 203B can be coupled to surround at least a portion of the internal components of the implant insertion apparatus 200. In certain embodiments, there is an audible click when snap-fit receiving members 242 and snap-fit engagement members 246 and / or the rim 240 and recess 244 are fully engaged. In alternative embodiments, the left and right housing portions 203A, 203B can be connected or otherwise coupled to each other via adhesion, screws, glue, welding (e.g., sonic welding), and / or the like. In some embodiments, a proximal tail 223 of the implant insertion apparatus 200 may be configured to detach from and reattach to the rest of the body (e.g., as indicated by the dashed line) via snap-fit or press-fit coupling mechanisms or configurations.

[0155] In some embodiments, the left and right housing portions 203 A, 203B can include one or more trigger tracks 248 to limit or otherw ise align the sliding trigger 214 within the external housing 202. The trigger tracks 248 can extend through some, most, substantially all, or all of the length of the rearward portion 206. forward portion 207, or all of the external housing 202. The trigger tracks 248 can be linear, curved, a mixture of linear and curved, or otherwise dimensioned to define a path to be followed by the sliding trigger 214. In some embodiments, the sliding trigger 214 can follo ^ a path in a first direction within the external housing 202, and then continue to follow a path in a second direction within the sliding trigger 214, where the second direction can be in the same direction, a slightly different direction, a different direction, or a substantially different direction than the first direction.

[0156] In some embodiments, the left and right housing portions 203 A, 203B can be configured to have a trigger stop 249 or other internal component dimensioned and positioned to control the operation of the implant assembly 300 or other internal components of the implant insertion apparatus 200. The trigger stop 249 can be positioned on either the left housing portion 203A or the right housing portion 203B, or on both the left and right housing portions 203 A, 203B. The trigger stop 249 can interact with a trigger spring 364 operatively connected with the implant assembly 300 (described further herein).

[0157] In various embodiments, the left housing portion 203A and the right housing portion 203B are composed of any rigid or semi-rigid material, such as plastic, polymer, metal, composites, or the like. In one embodiment, the left housing portion 203 A and the right housing portion 203B are molded from Lexan® polycarbonate. In some embodiments, at least a portion of the left housing portion 203A and / or the right housing portion 203B is composed of a flexible material, such as silicone or similar elastomeric or flexible polymers (including but not limited to acrylonitrile butadiene styrene (ABS), a blend of polycarbonate and ABS, polystyrene, polypropylene, and / or polyethylene.

[0158] With reference to Figures 3 and Figures 5A-5B, the internal components of the implant insertion apparatus 200 includes the implant assembly 300 according to some embodiments. The implant assembly 300 can include (i) a sliding trigger 214 configured to move proximally and distally within the implant insertion apparatus 200, (ii) a tube set assembly 350, and (iii) a collet holder assembly 358. The tube set assembly 350 can include a plurality of tubes configured to operatively work together to eject and withdraw an implant during a procedure. The collet holder assembly 358 can be configured to restrict at least a portion of the tube set assembly 350 by attaching it to the external housing 202 of the implant insertion apparatus 200.

[0159] In some embodiments, the tube set assembly 350 can comprise a backing rod 370, an introducer tube 380 and a collet 390. In some embodiments, the collet 390 can be fixedly connected or otherwise coupled to the backing rod 370 by via adhesion, screws, glue, welding (e.g., sonic welding), and / or the like. In some embodiments, the collet 390 and the backing rod 370 can form a unitary body. Operation of the tube set assembly 350 is explained further herein.

[0160] In some embodiments, the collet holder assembly 358 can comprise a collet holder 360 and a collet holder clip 362. In some embodiments, the collet holder 360 can align a portion of the tube set assembly 350 with the external housing 202. In some embodiments, the collet holder clip 362 can position the collet holder 360 within the external housing 202 to restrain movement of some components of the tube set assembly 350 within the external housing 202. In some embodiments, the members of the tube set assembly 350, such as the backing rod 370 and the introducer tube 380 have slots or openings in them sized to allow movement of the sliding trigger 214 relative to the implant insertion apparatus 200.

[0161] The angled implant assembly 300 advantageously provides beneficial ergonomics and more comfortable hand positions of the clinician operator during use. Forexample, the angled implant assembly 300 can allow the clinician operator to more easily reach certain portions of the eye. In some embodiments, the angled implant assembly 300 can allow the clinician operator to rotate the delivery apparatus 200 about an arc to efficiently and more easily access implantation locations spaced apart from each other (e.g., two or more locations spaced apart at various clock hours (e.g., two clock hours from each other) along various implant locations within the eye, such as along a circumference of Schlemm’s canal). In some embodiments, the angling of the introducer assembly advantageously allows the clinician operator to sweep out a wider arc to reach as much (e.g., up to 50% or more) of the conventional outflow system as possible through a single incision or opening into the eye. In some embodiments, the implant assembly 300 can be angled relative to an axis passing through the rearward portion 206 and the forward portion 207 and the external housing 202 of an implant insertion apparatus 200. In some embodiments, the implant assembly 300 may not be angled relative to an axis passing through the rearward portion 206 and the forward portion 207 and the external housing 202 of an implant insertion apparatus 200.

[0162] The internal components can be secured to or within the external housing 202 during assembly of the implant insertion apparatus 200 using various methods of fixation (e.g., adhesion, bonding, gluing, snap-fitting, and the like). The interaction of the internal components and the operation of the implant insertion apparatus 200 will be discussed in more detail later.

[0163] In certain embodiments, the implant insertion apparatus 200 is disposable or configured for a single use and includes one or more safety mechanisms that prevent reuse. For example, the safety' mechanism can be an internal component that renders the instrument inoperable if re-sterilized. In accordance with several embodiments, the safety- mechanism is that plastic parts do not survive sterilization with an autoclave. In some embodiments, the implant insertion apparatus 200 is preloaded yvith an implant 310 upon being provided in a kit, as explained further herein. In other embodiments, the implant insertion apparatus 200 is reloaded yvith implants, sterilized, and re-used on the same or a different patient.A. Trigger

[0164] Figures 5A and 5B illustrate an example of a sliding trigger 214. The sliding trigger 214 can be configured to partially protrude through an opening 212 of the implant insertion apparatus 200. The sliding trigger 214 can have an overall shape that canfit within an internal capacity of the external housing 202 to allow the sliding trigger 214 to substantially move within the external housing 202.

[0165] The sliding trigger 214 can include certain attachment features to limit the position of the sliding trigger 214 within the external housing 202. In some embodiments, the sliding trigger 214 has one or more trigger track protrusions 216 extending laterally out of one or more sides to restrict vertical movement of the sliding trigger 214 within the external housing 202. In some embodiments, as shown in Figures 4A and 4B, the external housing 202 can include one or more openings, slots, receptacles, or trigger tracks 248 which correspond with the trigger track protrusions 216 to define a pathway the sliding trigger 214 can move within the external housing 202. In some embodiments, the trigger tracks 248 can be positioned on the left or right housing portions 203 A, 203B.

[0166] In some embodiments, the sliding trigger 214 can have an upper portion and a lower portion. In some embodiments, the upper portion and the lower portion can be separate pieces that interface with each other before or during installation of the sliding trigger 214 into the external housing 202. The upper portion can have a narrower portion and a thicker portion. The thicker portion can be configured to extend through the opening 212 in the external housing 202. The thicker portion can be textured by ridges or other features designed to provide grip to a user while manipulating the implant insertion apparatus 200. The narrower portion can be configured to pass through an opening 212 in the external housing 202. The opening 212 and the narrower portion can be configured to limit the movement of the sliding trigger 214 within the external housing 202. The lower portion can include a plurality of trigger track protrusions 216 that can align the sliding trigger 214 with the external housing 202. The lower portion can include a section which operatively connects to a portion of the tube set assembly 350, such that movement of the sliding trigger 214 causes corresponding movement to the connected portion of the tube set assembly 350.

[0167] In some embodiments, the sliding trigger 214 is secured to the introducer tube 380 of the tube set assembly 350. The sliding trigger 214 can be connected to the introducer tube 380 when the sliding trigger 214 is assembled with the external housing 202, or can be secured to the introducer tube 380 before installation in the external housing 202. In some embodiments, the introducer tube 380 is sized and / or designed to snap to or otherwise reside within at least a portion of the sliding trigger 214. In some embodiments, the sliding trigger 214 has a passageway or opening configured to pass all or a portion ofthe tube set assembly 350 through the sliding trigger 214. As explained in more detail below, the sliding trigger 214 can be dimensioned such that, as the sliding trigger 214 and the introducer tube 380 moves within the external housing 202, the sliding trigger 214 and introducer tube 380 move relative to the backing rod 370.B. Collet Holder Assembly

[0168] In some embodiments, the implant assembly 300 can include a collet holder 360 configured to align or otherwise position all or a portion of the implant assembly 300 within the external housing 202. In some embodiments, the collet holder assembly 358 comprises a collet holder 360 sized and / or dimensioned to fit within a cavity or opening in a distal end portion 220 of the external housing 202, such as within the cone-shaped nose 205. The collet holder assembly 358 can partially extend beyond the external housing 202.

[0169] In some embodiments, the collet holder 360 can be secured in the proximal-distal direction within the implant insertion apparatus 200 by a collet holder clip 362 which can interface with a collet holder interface 225 in the external housing 202. The collet holder interface 225 can be positioned in either of the left and right housing portions 203 A, 203B of the external housing 202.

[0170] In some embodiments, the collet holder clip 362 can retain the collet holder 360 by passing through a portion of the collet holder 360, by passing through a portion of the tube set assembly 350. In some embodiments, the collet holder clip 362 can retain the tube set assembly 350 within the implant assembly 300 by exerting a frictional force by compression of the collet holder 360, or by other means known by one skilled in the art. Alternatively or in addition, the collet holder clip 362 can be glued, sintered, welded, or otherwise permanently or non-permanently attached to the collet holder 360. In some embodiments, the collet holder 360 and the collet holder clip 362 can form a unitary body.

[0171] In some embodiments, the collet holder assembly 358 can align the tube set assembly 350 within the external housing 202. In some embodiments, the collet holder assembly 358 can restrain the distal-proximal movement of the backing rod 370. In some embodiments, the collet holder assembly 358 can connect the left and right housing portions 203 A, 203 B.C. Trigger Spring

[0172] In some embodiments, the implant assembly 300 can further include a trigger spring 364 designed to assist in positioning of the sliding trigger 214 within theextemal housing 202. In some embodiments, the trigger spring 364 can be connected to the sliding trigger 214 such that movement of the sliding trigger 214 within the external housing 202 also moves the trigger spring 364 within the external housing 202.

[0173] In some embodiments, the trigger spring 364 can be configured to interact with one or more features within the external housing 202. In some embodiments, the trigger spring 364 can be dimensioned or angled to interface with a trigger stop 249 which can interfere with or substantially stop the movement of the sliding trigger 214 within the external housing 202. In some embodiments, the trigger spring 364 can be configured to bias the sliding trigger 214 in a certain position during certain configurations. In some embodiments, the trigger spring 364 can bias the sliding trigger 214 in a first configuration, where the introducer tube 380 is in its distal-most position.

[0174] Figures 6A, 6B, and 6C illustrate a sectional-view of the left housing portion 203A of an external housing 202 and a sliding trigger 214 as the sliding trigger 214 moves through various configurations according to one embodiment. Portions of the left housing portion 203 A, such as the trigger track 248 and trigger stop 249. are visible in these figures. Figure 6A depicts the sliding trigger 214 in a first configuration, Figure 6B depicts the sliding trigger 214 in a second configuration, and Figure 6C depicts the sliding trigger 214 in a third configuration. In some embodiments, as the sliding trigger 214 moves from the first configuration to the second configuration and / or to the third configuration, the trigger track protrusions 216 move along a path defined by the trigger track 248. In some embodiments, the trigger spring 364 is generally relaxed when in the first configuration, and generally under some stress or load when in the second configuration and / or the third configuration.

[0175] In some embodiments, the trigger spring 364 can be sized and dimensioned to limit lateral movement of the sliding trigger 214 within the external housing 202, yet allow for limited proximal movement of the sliding trigger 214.

[0176] In some embodiments, the trigger spring 364 can provide a feedback to the user based on the position of the sliding trigger 214. In some embodiments, as the sliding trigger 214 is moved from its first configuration to its second configuration, the trigger spring 364 can interact with a trigger stop 249. The trigger spring 364 can have a ramped portion, curved portion, or otherwise trigger spring bend 365 which would make contact or otherwise interact with a trigger stop 249 on the external housing 202. In some embodiments, the trigger spring 364 and / or the trigger spring bend 365 can be made of a ferromagnetic material, and the trigger stop 249 can have apply a magnetic force to thetrigger spring bend 365 once the sliding trigger 214 moves closer to the trigger stop 249 when moving between the first and second configuration.

[0177] In some embodiments, the feedback provided to the user can be a physical feedback (e.g., force-feedback or haptic feedback). In some embodiments, the physical feedback can come from the trigger spring bend 365 making contact with the trigger stop 249. In some embodiments, the feedback can be an auditory’ feedback, such as a clicking sound made by the trigger spring 364 contacting the trigger stop 249. In some embodiments, the feedback can be a resistance to further movement of the sliding trigger 214.

[0178] In some embodiments, the trigger spring can require a second motion to advance the sliding trigger 214 from a second configuration to a third configuration. In some embodiments, the sliding trigger 214 may need to be pushed vertically once the sliding trigger 214 is in the second position to transition the sliding trigger 214 from its second configuration to its third configuration. In some embodiments, the sliding trigger 214 may need to be rotated along an axis of the implant assembly 300 once the sliding trigger 214 is in the second position to transition the sliding trigger 214 from its second configuration to its third configuration.

[0179] Figure 6C illustrates the sliding trigger 214 and trigger spring 364 in the third configuration. In some embodiments, the trigger spring 364 can be configured such that, after the trigger spring bend 365 moves proximally past the trigger stop 249. the trigger spring 364 deforms or otherwise changes dimensions such that the trigger spring bend 365 can move past the trigger stop 249. In some embodiments, the trigger spring 364 can deform vertically around the trigger stop 249. When in the third configuration, the sliding trigger 214 is prevented from further movement by the trigger spring stop 366 of the trigger spring 364 interfacing with the trigger stop 249.

[0180] In some embodiments, as the sliding trigger 214 moves from the second configuration to the third configuration, a feedback can also be provided to the user. The feedback can be a feedback as previously described herein. The feedback could also be a resistance felt by the dragging of the trigger spring bend 365 along the trigger stop 249.

[0181] In some embodiments, the trigger track 248 can be non-linear in its path such that movement of the sliding trigger 214 along the path generated by the trigger track 248 causes the trigger spring 364 to interface with the trigger spring bend 365.

[0182] In some embodiments, the trigger spring 364 can be positioned elsewhere along the sliding trigger 214, or be positioned within the external housing 202 tooperatively interact with the trigger track protrusions 216 as the trigger track protrusions 216 move along the path defined by the trigger track 248 within the external housing 202.

[0183] In some embodiments, the sliding trigger 214 and trigger spring 364 can be integrally formed, as described later herein, such as in reference to embodiments depicted in Figures 14A through 14E.IV. Configuration of the Tube Set Assembly and Implant

[0184] In some embodiments, the sliding trigger 214 is configured to interface with the tube set assembly 350 when assembled. Figure 7 depicts a focused view of the distal end of the tube set assembly 350 according to some embodiments. The tube set assembly 350 in some embodiments can comprise a backing rod 370, an introducer tube 380, and a collet 390.A. Backing Rod

[0185] In some embodiments, the backing rod 370 can be a radially-innermost member of the tube set assembly 350. The backing rod 370 can be configured to remain stationary within the implant insertion apparatus 200 as the sliding trigger 214 moves between its first configuration, its second configuration, and its third configuration. The backing rod 370 can provide the tube set assembly 350 rigidity' to increase the strength of the portion of the tube set assembly 350 extending beyond the external housing 202.

[0186] In some embodiments, the backing rod 370 can remain stationary within the implant insertion apparatus 200. In some embodiments, the backing rod 370 can be restricted by the collet holder assembly 358.

[0187] In some embodiments, the backing rod 370 can prevent or substantially prevent aqueous outflow from the eye during an implanting procedure.

[0188] In some embodiments, the backing rod 370 can press against a proximal surface of the implant 310 during installation to ensure the installation of the implant 310 into an implant location. In some embodiments, the backing rod 370 can be physically connected to the collet 390.B. Introducer Tube

[0189] In some embodiments, the introducer tube 380 can be the radially - outermost member of the tube set assembly 350. The introducer tube 380 can be configured to move with the sliding trigger 214 as the sliding trigger 214 moves between its first configuration, its second configuration, and its third configuration.

[0190] In some embodiments, the introducer tube 380 has a curved, beveled, tapered, or sharpened distal end to facilitate entry into the eye. In some embodiments, the introducer tube 380 has a sharpened distal end so an incision is not required before insertion of the tube set assembly 350 into the eye.

[0191] In some embodiments, the introducer tube 380 has a slot or otherwise allows the collet holder assembly 358 to interact with the backing rod 370 as the tube set assembly 350 exits the external housing 202 at the cone-shaped nose 205.

[0192] In some embodiments, the introducer tube 380 is designed such that, as the sliding trigger 214 moves from its first configuration to its second configuration, or as the sliding trigger 214 moves from its second configuration to its third configuration, the introducer tube 380 allows the collet 390 to transition between its configurations, as described herein.C. Collet

[0193] In some embodiments, the collet 390 is located radially between the a portion backing rod 370 and the introducer tube 380. In some embodiments, the collet 390 has a thickness and is made of a material with sufficient rigidity to retain an implant 310 when in the first and second configuration.

[0194] In some embodiments, the collet 390 is designed to retain the implant 310 while the implant insertion apparatus 200 is in the first configuration and the second configuration. In some embodiments, the collet 390 is configured to release the implant 310 when in the third configuration.

[0195] In some embodiments, the collet 390 can have one or more collet arms 394 separated by an opening 392 along the length of the collet 390. In some embodiments, the collet 390 can have two, three, four, five, or more than five collet arms 394. The collet arms 394 can be generally biased outwards and have sufficient flexibility to bend between the first configuration, the second configuration, and the third configuration.

[0196] In some embodiments, the collet arms 394 can have collet protrusions 396 configured to interface with corresponding collet interface portions 322 on the implant 310. In some embodiments, the distal-proximal length of the collet protrusions 396 can be 50% to 80% of the distal-proximal length of the collet interface portion 322 on the implant 310. In some embodiments, the distal-proximal length of the collet protrusions 396 can be any other percentage of the distal-proximal length of the collet interface portion 322 on the implant 310 (e.g., 50% to 65%. 50% to 60%, 55% to 70%. 60% to 75%, 65% to 80%, overlapping ranges thereof, or any value within the recited ranges), as desired or required.

[0197] In some embodiments, the distal-proximal length of the collet protrusions 396 can be between 80% and 100% of the distal-proximal length of the collet interface portion 322 on the implant 310. In some embodiments, the collet protrusions 396 can partially extend beyond and encircle the collet interface portion 322 on the implant 310.

[0198] In some embodiments, the distal-proximal length of the collet protrusions 396 can be between 0.01% and 50% of the distal-proximal length of the collet interface portion 322 on the implant 310.

[0199] In some embodiments, the collet protrusions 396 can contact the implant 310 at multiple locations along the collet interface portion 322. In some embodiments, the collet protrusions 396 contacting the implant 310 at multiple locations along the collet interface portion 322 can assist in appropriately aligning the implant 310 with the implant location, with providing sufficient grip strength to facilitate insertion or removal of an implant, or other beneficial reasons. In some embodiments, the contact surface of the collet protrusions 396 can be treated with a chemical, plastic, or otherwise be treated or made of a different material than the remainder of the collet 390 to increase the grip or connective strength between the collet 390 and the implant 310 when the tube set assembly 350 is in the first configuration and the second configuration.

[0200] In some embodiments, the collet arms 394 can be biased generally outwards. In the first configuration, the collet arms 394 can be located generally radially inwards and be retained by the introducer tube 380. In some embodiments, when in the first configuration the collet arms 394 and the collet 390 can be entirely positioned within the distal most end of the introducer tube 380, such that all or substantially all of the implant 310 is within the introducer tube 380. When in the first configuration, the collet 390 can generally be bent to be radially inward by pressing against the introducer tube 380.

[0201] In some embodiments, in the second configuration, a portion of the collet 390 can be positioned distally out from the introducer tube 380. The collet arms 394 can be positioned partially out of the introducer tube 380 such that a distal end of the implant 310 is exposed from the introducer tube 380. In some embodiments, when in the second configuration, the distal most portion of the implant extends beyond the distal most portion of the introducer tube 380. When in the second configuration, the collet 390 can generally be bent to be radially inward by pressing against the introducer tube 380.

[0202] In some embodiments, in the third configuration, the collet arms 394 can return to their generally relaxed radially outward position (as shown in FIG. 12B, discussed herein). In the third configuration, in some embodiments, the implant 310 is no longerconnected to the tube set assembly 350 by the collet protrusions 396 of the collet 390, and is free to move relative to the tube set assembly 350 and implant insertion apparatus 200.

[0203] In some embodiments, the collet protrusions 396 can exert sufficient force on the collet interface portion 322 of the implant 310 to remove or implant the implant 310 into a tissue in the eye.

[0204] Multiple embodiments of a collet 390 are envisioned. Severe embodiments are described herein, but one skilled in the art can appreciate that other variations of these designs can be combined and / or modified based on the desired use case.

[0205] In some embodiments, the collet 390 can be 3D printed or otherwise additively manufactured.

[0206] In some embodiments, the collet protrusions 396 can be produced separately from the collet 390 and the collet arms 394 and be attached during manufacturing of the implant insertion apparatus 200.

[0207] In some embodiments, the collet arms 394 can each be separate parts and be attached to the backing rod 370 via adhesion, screws, glue, welding (e.g., sonic welding), and / or the like various methods.

[0208] In some embodiments, the collet 390 can be machined from a singular piece and the openings 392 between collet arms 394 can be cut to produce the collet arms 394 and collet protrusions 396. In some embodiments, the collet arms 394 can then be biased radially outwards.

[0209] In some embodiments, the collet 390 can comprise multiple pieces stamped from metal sheets and formed to have geometry' corresponding with openings 392, collet arms 394, and collet protrusions 396. The multiple pieces can then be attached to a backing rod 370, and be biased radially outward.

[0210] In some embodiments, the collet 390 can be made of a flexible material, such as silicone or similar elastomeric or flexible polymers (including but not limited to acry lonitrile butadiene styrene (ABS), a blend of polycarbonate and ABS, polystyrene, polypropylene, and / or polyethylene. In other embodiments, the collet 390 can be constructed of other suitable materials, such as other metals, plastics, or polymers.

[0211] In some embodiments, the collet 390 can be integrally formed with the backing rod 370 to form a unitary body.

[0212] In some embodiments, the collet 390 can have features adjusted so as to conform with other design requirements of the implant 310, or other possible embodiments of ocular implants, as described herein.D. Implant

[0213] In some embodiments, the implant insertion apparatus 200 can be preloaded with an implant 310 designed to treat an ocular disorder. Figures 8A through 8E depict one possible embodiment of an implant 310. The implant 310 can generally have a main body 311 portion comprising a distal end 312 and a proximal end 314, a reservoir lid 328, and a cap 324 configured to retain or contain a treatment fluid within the implant 310.

[0214] The distal end 312 of the implant 310 can comprise an implant connection end 316 configured to penetrate a tissue within the eye and release a treatment fluid from within the reservoir 326 of the implant 310. The implant connection end 316 can have a sharpened end 318 with a material and design consistent with penetrating the ocular tissue at an implant location. The implant connection end 316 can further comprise a retaining portion 320 or other feature designed to maintain the position of the implant 310 once implanted at the implant location.

[0215] In some embodiments, the implants have a generally sharpened forward end and are self-trephinating or self-trephining (e.g.. self-penetrating), so as to pass through tissue without pre-forming an incision, hole or aperture. The sharpened forward end can be, for example, conical or tapered. The tip can be sufficiently sharp to pierce eye tissue. The tip also can be sufficiently blunt so as not to substantially penetrate eye tissue. The taper angle of the sharpened end can be, for example, about 30°±15° in some embodiments. The radius of the tip can be about 70 to about 200 microns. Where an outlet opening is formed at the distal end of the implant, the distal portion can gradually increase in cross- sectional size in the proximal direction, preferably at a generally constant taper or radius or in a parabolic manner.

[0216] In some embodiments, the implant 310 can include a collet interface portion 322 designed to position the implant 310 within the tube set assembly 350 during delivery' and retrieval of the implant. In some embodiments, the collet interface portion 322 can include two wall members that circumscribe the implant 310 at a set distance apart, the distance being compatible with the proximal-distal length of the collet protrusions 396 of the tube set assembly 350 used in an implant insertion apparatus 200. In some embodiments, the radial height of the walls forming the collet interface portion 322 can be of a height sufficient to prevent or substantially prevent premature disconnection of the implant 310 from the tube set assembly 350 when in the first and second configurations, during shipping of the implant insertion apparatus 200, or for other unintended events.

[0217] In some embodiments, the reservoir lid 328 can assist with retaining the treatment fluid within the reservoir 326 of the implant 310. In some embodiments, the reservoir lid 328 can be made of an impermeable material to prevent or substantially prevent the treatment fluid from prematurely exiting the implant 310. In some embodiments, portions of the reservoir lid 328 can be made of a permeable material to facilitate timed release of treatment fluid from the implant 310. In some embodiments, all or substantially all of the reservoir lid 328 can be made of a permeable matenal to facilitate timed release of treatment fluid from the implant 310. In some embodiments, the reservoir lid 328 can be maintained against the proximal end 314 of the implant 310 by the cap 324.

[0218] In some embodiments, the proximal end 314 can comprise a ridge or other member to assist with connecting the cap 324 to the implant 310. In some embodiments, the cap 324 can be connected to the main body 311 by crimping a portion325 of the cap 324 over the ridge or other member, as shown in FIG. 8D. In some embodiments, the cap 324 can be connected to the implant 310 after the treatment fluid has been loaded into the reservoir 326 of the implant 310. In some embodiments, the cap 324 can have a cap opening 329 in its proximal end to allow for treatment fluid to exit the implant 310. In some embodiments, the cap 324 can have a permeable membrane on its distal end to facilitate timed release of treatment fluid from the implant 310.

[0219] In some embodiments, treatment fluid can exit the implant 310 or elute to the eye by one or more of several treatment fluid pathways 330 that connect the reservoir326 with the aqueous of the eye and / or the implant location. In some embodiments, the treatment fluid pathways 330 can be channels cut within the body of the implant 310.

[0220] In some embodiments, the treatment fluid pathway 330 can elute through the reservoir lid 328 and exit the implant 310 by an opening 329 in the cap 324.

[0221] In some embodiments, the treatment fluid pathway 330 can pass through a side wall in the main body 311 of the implant 310.

[0222] In some embodiments, the treatment fluid pathway 330 can pass through the distal end 312 of the implant 310 and exit the implant 310 in the implant connection end 316.

[0223] In some embodiments, the reservoir 326 of the implant 310 can be multichambered to allow for different treatment fluids to flow to different portions of the eye.

[0224] Other possible embodiments of implants are disclosed in U.S. Patent Number 10,206,813 and PCT Publication U.S. 2016 / 049998. the entirety of which are incorporated by reference herein.IV. Configurations of Tube Set Assembly During Method of Operation

[0225] Figures 9A through 12B depict the distal end of a tube set assembly 350 according to one embodiment as it transitions between configurations during an implanting procedure. The figures generally depict the tube set assembly 350 as the sliding trigger 214 and implant insertion apparatus 200 move from their first configuration to their second configuration and from their second configuration to their third configuration.

[0226] Figures 9A and 9B depict the tube set assembly 350 in a first configuration. In the first configuration, the sliding trigger 214 is in its first configuration in its first position, as described herein. In the first configuration, the implant 310 is positioned substantially within the angled end 382 of the introducer tube 380 of the tube set assembly 350.

[0227] In the first embodiment, the implant insertion apparatus 200 can be inserted into an incision in the eye. In some embodiments, the incision into the eye can be 1.5 millimeters across, 1.4 millimeters across, 1.3 millimeters across. 1.2 millimeters across. 1.1 millimeters across. 1 millimeter across, less than 1 millimeters across, overlapping ranges thereof, or any value within the recited ranges, as desired or required. In some embodiments, the angled end 382 advantageously assists inserting the tube set assembly 350 into the eye. In some embodiments, the tube set assembly 350 can be inserted into the eye without the need for another tool to lift the incision. In some embodiments, the angled end 382 can be angled to facilitate entry into the eye. In some embodiments, the angled end 382 can be sharpened such that insertion of the tube set assembly 350 into the eye does not require an incision to be formed before insertion.

[0228] Figures 10A and 10B depict the tube set assembly 350 in a second configuration. In the second configuration, the sliding trigger 214 is in its second configuration in its second position, as described herein. In some embodiments, the trigger spring bend 365 of the trigger spring 364 can be against the trigger stop 249 of the external housing 202.

[0229] In the second configuration, the introducer tube 380 can be partially withdrawn proximally by the sliding trigger 214 to expose all or substantially all of the distal end 312 of the implant 310. In some embodiments, all or substantially all of the implant 310 can be positioned to be distal the angled end 382 of the introducer tube 380. The collet arms 394 of the collet 390 can be substantially within the introducer tube 380 inthe second configuration, such that the collet 390 and tube set assembly 350 maintain a firm connection with the collet interface portion 322 of the implant 310.

[0230] In the second configuration, the implant 310 can be implanted into an implant location within the eye. The implant location can vary as required or desired for the desired effect to treatment plan. In some embodiments, the implant location can be in the anterior chamber of the eye. In some embodiments, the implant location can be in the supraciliary space of the eye. In some embodiments, the implant location can be in the sclera behind Schlemm’s canal.

[0231] Figures 11A and 11B depict the tube set assembly 350 between the second configuration and the third configuration. In this position, the sliding trigger 214 moves between its second configuration and its third configuration, as described herein. In some embodiments, the trigger spring bend 365 of the trigger spring 364 can be passing over the trigger stop 249 of the external housing 202.

[0232] In this position, the introducer tube 380 can be withdrawn proximally by the actuation of the sliding trigger 214, and the flexible collet arms 394 of the collet 390 can begin returning to their radially outward resting position. As the introducer tube 380 moves backward, the collet protrusions 396 make less contact with the collet interface portion 322, and the implant 310 begins to be free from the implant insertion apparatus 200.

[0233] Figures 12A and 12B depict the tube set assembly 350 in a third configuration. In the third configuration, the sliding trigger 214 is in its third configuration in its third position, as described herein. In some embodiments, the trigger spring stop 366 of the trigger spring 364 can be against the trigger stop 249 of the external housing 202.

[0234] In the third configuration, the introducer tube 380 can be fully withdrawn proximally by the sliding trigger 214 to expose the implant 310. In the third configuration, the collet protrusions 396 no longer make contact with the implant 310, and the implant 310 can maintain its connection with the implant location. The implant insertion apparatus 200 can be moved relative to the implant 310 in the third configuration.V. Example Method of Use of Implant Insertion Apparatus

[0235] Figure 13A illustrates an example method 400 of inserting an ocular implant into the eye. At step 402, a user or operator, such as a doctor or clinician, can insert a portion of the implant insertion apparatus into the patient’ s eye and advance it to a location adjacent a desired implantation site. A small self-sealing incision or opening can be madein the cornea 112 at or near the limbus or in other external surface area of the eye, or the angled end 382 of the introducer tube 380 can puncture the external area of the eye.

[0236] The user can grip the implant insertion apparatus 200 and rotate their hand so that their elbow is positioned by a side of the user’s body. In some embodiments, the apparatus is rotated significantly in the user’s hand (e.g., rotated right between 10 and 90 degrees with respect to a central longitudinal axis of the apparatus 200). In some embodiments, the portion inserted can be a portion of the tube set assembly 350. In certain embodiments, the tube set assembly 350 is inserted from a site transocularly situated from the desired implantation site. The distal end of the tube set assembly 350 is then advanced across the anterior chamber 120 toward the desired implantation site within the trabecular meshwork 121 (e.g., under gonioscopic guidance). In some embodiments, the tube set assembly 350 can be inserted ab extemo. In some embodiments, the tube set assembly 350 can be inserted ab intemo.

[0237] In step 404, before reaching the desired implantation site, the user converts the implant insertion apparatus 200 from its first configuration to its second configuration by the user withdrawing the sliding trigger 214 in the first direction from its first configuration to its second configuration. This can prepare the implant insertion apparatus 200 for insertion into an implant location in the eye by exposing the implant 310 and its implant connection end 316.

[0238] In step 406, the tube set assembly 350 is advanced to the desired implantation site, and the implant connection end 316 of the implant 310 is inserted into the tissue of the eye. The implant 310 can anchor (e.g., connect, harpoon, fasten, etc.) into the implant location with the implant connection end 316. If being implanted in the sclera 111 in the anterior portion of Schlemm’s canal, the implant connection end 316 can enter a portion of the sclera and the retaining portion 320 can be positioned to be within Schlemm’s canal 122 behind the trabecular meshwork 121. The depth of the implant 310 can be determined by visualization (e.g., imaging or fiberoptic) or tactile methods or by depth markings or a depth stop on the implant 310 or the tube set assembly 350. The implant location may become depressed by the pressure exerted by the implant connection end 316.

[0239] Optionally, at optional step 408, strength of a connection between the implant 310 and the implant location can be tested by slightly moving the tube set assembly 350 laterally and / or distally while in the second configuration to see if the implant 310 moves the implant location. If the strength of the connection is insufficient, the implant 310 may not remain connected with the implant location, and step 406 may need to be repeated.If the strength of the connection is sufficient, the tube set assembly 350 can be returned to its position prior to optional step 408.

[0240] In step 410, upon the implant 310 being anchored to the implant location, the user can slightly back the tube set assembly 350 off from the implant location such that the implant location can return to a resting state and convert the implant insertion apparatus 200 from its second configuration to its third configuration by the user withdrawing the sliding trigger 214 in the first direction from its second configuration to its third configuration.

[0241] In step 412, the tube set assembly 350 can be partially withdrawn from the implant location to confirm that the implant 310 is separated from the tube set assembly 350 and the implant insertion apparatus 200. In this step, the implant insertion apparatus 200 can be in the third configuration, or can be transitioning from the third configuration to the second configuration. In this step, if the implant insertion apparatus 200 is being converted from the third configuration to the second configuration, the tube set assembly 350 must be withdrawn a sufficient distance such that the collet 390 will not interact with the implant 310.

[0242] In optional step 414, the tube set assembly 350 can be converted from its previous configuration to either its second configuration or its first configuration. In this step, the tube set assembly 350 must be withdrawn a sufficient distance such that the collet 390 will not interact with the implant 310.

[0243] In optional step 416, the tube set assembly 350 can be entirely withdrawn from the eye. During this step, the implant assembly 300 may either be in its first configuration or in its second configuration.

[0244] Advantageously, the method 400 of implanting using the implant insertion apparatus 200 can use an implant that is substantially smaller than previous incisions. In some embodiments, the incision can be 1 mm across. In some embodiments, the incision can be less than 1 mm across. In some embodiments, the incision can be slightly more than 1 mm across. In some embodiments, the method 400 may not require the use of viscoelastic during the procedure. In some embodiments, the method 400 can include an optional step of applying viscoelastic to the eye. In some embodiments, the method 400 can be a closed chamber surgery7. In some embodiments, the method 400 can be performed in a doctor's office and does not require a surgical suite or operating room of a hospital or surgical center.

[0245] Optionally, at any point after separation of the implant 310 from the implant assembly 300 in step 410, the strength of the connection between the implant location and implant 310 can be confirmed by tapping the side of the implant 310 with a distal end of the implant assembly 300.

[0246] Optionally, at any point after installation of the implant 310 in step 406, the strength of the connection between the implant location and the implant 310 can be increased by pressing on the proximal end of the cap 324 with the distal end of the backing rod 370 when the tube set assembly 350 is in the third configuration, with the distal end of the collet protrusions 396 when the tube set assembly 350 is in the second configuration, or any other portion of the tube set assembly 350 when in a desirable configuration.

[0247] Figure 13B illustrates an example method 500 of withdrawing an implant from the eye. In optional step 502, a user or operator, such as a doctor or clinician, can insert a portion of the implant insertion apparatus in its first configuration that is not preloaded with an implant 310 into the patient’s eye and advance it to a location adjacent a desired implantation site. The user can grip the implant insertion apparatus 200 and rotate their hand so that their elbow is positioned by a side of the user’s body. In some embodiments, the apparatus is rotated significantly in the user’s hand (e g., rotated right between 10 and 90 degrees with respect to a central longitudinal axis of the apparatus 200). In some embodiments, the portion inserted can be a portion of the tube set assembly 350. In some embodiments, the tube set assembly 350 can be inserted ab extemo. In some embodiments, the tube set assembly 350 can be inserted ab intemo.

[0248] In optional step 504, if the tube set assembly 350 is not already in its third configuration, then the tube set assembly 350 can be converted from its current configuration to its third configuration. The distal end of the tube set assembly 350 during this step can be advanced across the anterior chamber 120 toward the desired implantation site.

[0249] In step 506, the tube set assembly 350 can be positioned around an implant 310 that has been implanted into an implant area of the eye. The tube set assembly 350 can be positioned such that the distal end of the backing rod 370 is approximately lined up with the proximal end of the implant 310, and the collet arms 394 are positioned to be approximately in line with the collet interface portion 322 of the implant 310.

[0250] In step 508, the user can begin converting the tube set assembly 350 from its third configuration to its second configuration such that the collet protrusions 396 interact or otherwise align with the collet interface portion 322 of the implant 310. Duringthis step, if the collet protrusions 396 are not aligned with the collet interface portion 322 of the implant 310. the user can slightly change the position of the proximal end 314 or the implant insertion apparatus 200 until a secure connection between the collet protrusions 396 and the collet interface portion 322 occurs.

[0251] In step 510, the implant 310 can be removed from the implant location by converting the tube set assembly 350 from the second configuration to the first configuration. In some embodiments, the implant can be removed from the implant location by carefully withdrawing the implant insertion apparatus 200 in a proximal direction away from the eye.

[0252] In optional step 512, if the tube set assembly 350 is not already, the tube set assembly 350 can be converted into a first configuration.

[0253] In step 514, the tube set assembly 350 can be entirely withdrawn from the eye.

[0254] Figure 13C illustrates an example method 600 of inserting an ocular implant into the eye and retrieving a spent ocular implant. At step 602, a user or operator, such as a doctor or clinician, can insert a portion of the implant insertion apparatus into the patient’s eye and advance it to a location adjacent a desired implantation site. A small selfsealing incision or opening can be made in the cornea 112 at or near the limbus or in other external surface area of the eye, or the angled end 382 of the introducer tube 380 can puncture the external area of the eye.

[0255] The user can grip the implant insertion apparatus 200 and rotate their hand so that their elbow is positioned by a side of the user’s body. In some embodiments, the apparatus is rotated significantly in the user’s hand (e g., rotated right between 10 and 90 degrees with respect to a central longitudinal axis of the apparatus 200). In some embodiments, the portion inserted can be a portion of the tube set assembly 350. In certain embodiments, the tube set assembly 350 is inserted from a site transocularly situated from the desired implantation site. The distal end of the tube set assembly 350 is then advanced across the anterior chamber 120 toward the desired implantation site within the trabecular meshwork 121 (e.g., under gonioscopic guidance). In some embodiments, the tube set assembly 350 can be inserted ab extemo. In some embodiments, the tube set assembly 350 can be inserted ab intemo.

[0256] In step 604, before reaching the desired implantation site, the user converts the implant insertion apparatus 200 from its first configuration to its second configuration by the user withdrawing the sliding trigger 214 in the first direction from itsfirst configuration to its second configuration. This can prepare the implant insertion apparatus 200 for insertion into an implant location in the eye by exposing the implant 310 and its implant connection end 316.

[0257] In step 606, the tube set assembly 350 is advanced to the desired implantation site, and the implant connection end 316 of the implant 310 is inserted into the tissue of the eye. The implant 310 can anchor (e.g., connect, harpoon, fasten, etc.) into the implant location with the implant connection end 316. If being implanted in the sclera 1 11 in the anterior portion of Schlemm’s canal, the implant connection end 316 can enter a portion of the sclera and the retaining portion 320 can be positioned to be within Schlemm’s canal 122 behind the trabecular meshwork 121. The depth of the implant 310 can be determined by visualization (e.g., imaging or fiberoptic) or tactile methods or by depth markings or a depth stop on the implant 310 or the tube set assembly 350. The implant location may become depressed by the pressure exerted by the implant connection end 316.

[0258] Optionally, at optional step 608, strength of a connection between the implant 310 and the implant location can be tested by slightly moving the tube set assembly 350 laterally and / or distally while in the second configuration to see if the implant 310 moves the implant location. If the strength of the connection is insufficient, the implant 310 may not remain connected with the implant location, and step 406 may need to be repeated. If the strength of the connection is sufficient, the tube set assembly 350 can be returned to its position prior to optional step 408.

[0259] In step 610, upon the implant 310 being anchored to the implant location, the user can slightly back the tube set assembly 350 off from the implant location such that the implant location can return to a resting state and convert the implant insertion apparatus 200 from its second configuration to its third configuration by the user withdrawing the sliding trigger 214 in the first direction from its second configuration to its third configuration.

[0260] Optionally, after separation of the implant 310 from the implant assembly 300 in step 610, the strength of the connection between the implant location and implant 310 can be confirmed by tapping the side of the implant 310 with a distal end of the implant assembly 300.

[0261] In step 612, the tube set assembly 350 can be partially withdrawn from the implant location to confirm that the implant 310 is separated from the tube set assembly 350 and the implant insertion apparatus 200. In this step, the implant insertion apparatus 200 can be in the third configuration, or can be transitioning from the third configurationto the second configuration. In this step, if the implant insertion apparatus 200 is being converted from the third configuration to the second configuration, the tube set assembly 350 must be withdrawn a sufficient distance such that the collet 390 will not interact with the implant 310.

[0262] In step 614, the tube set assembly 350 can be positioned around a second implant 310 that has already been implanted into an implant area of the eye prior to method 600. The tube set assembly 350 can be positioned such that the distal end of the backing rod 370 is approximately lined up with the proximal end of the implant 310, and the collet arms 394 are positioned to be approximately in line with the collet interface portion 322 of the implant 310.

[0263] In step 616, the user can begin converting the tube set assembly 350 from its third configuration to its second configuration such that the collet protrusions 396 interact or otherwise align with the collet interface portion 322 of the second implant 310. During this step, if the collet protrusions 396 are not aligned with the collet interface portion 322 of the implant 310, the user can slightly change the position of the proximal end 314 or the implant insertion apparatus 200 until a secure connection between the collet protrusions 396 and the collet interface portion 322 occurs.

[0264] In step 618, the implant 310 can be removed from the implant location by converting the tube set assembly 350 from the second configuration to the first configuration. In some embodiments, the implant can be removed from the implant location by carefully withdrawing the implant insertion apparatus 200 in a proximal direction away from the eye.

[0265] In optional step 620, if the tube set assembly 350 is not already, the tube set assembly 350 can be converted into a first configuration.

[0266] In step 622, the tube set assembly 350 can be entirely withdrawn from the eye.

[0267] In some embodiments, an implant insertion apparatus 200 can be provided to a user with the implant 310 already installed. In some embodiments, the implant insertion apparatus 200 can be provided to a user without the implant installed, and the user can be provided with a plurality of implants 310 positioned on a sterile delivery unit. In some embodiments, the user can position the implant insertion apparatus 200 and tube set assembly 350 to grasp the implant 310 and remove it from the sterile delivery unit, following corresponding steps as if the user is removing an implant 310 from the eye.VI. Example Implants and Implantation Locations

[0268] The implant is preferably made of one or more biocompatible materials. Suitable biocompatible materials include, for example, polypropylene, polyimide, glass, nitinol, polyvinyl alcohol, polyvinyl pyrolidone, collagen, chemically-treated collagen, polyethersulfone (PES), poly(styrenc-isobutyl-styrene). Pebax, acry lic, polyolefin, polysilicon, polypropylene, hydroxyapatite, titanium, gold, silver, platinum, other metals, ceramics, plastics and a mixture thereof. The implants can be manufactured by sintering, micro machining, laser machining, and / or electrical discharge machining. However, other suitable manufacturing methods can be used.

[0269] If desired, more than one implant of the same or different pe may be implanted. Additionally, implantation may be performed in combination with other surgical procedures, such as cataract surgery. All or a portion of the implant may be coated, e.g. with heparin, preferably in the flow path, to reduce blood thrombosis or tissue restenosis. In accordance with several embodiments, the same implant insertion apparatus 200 may be used to deliver different sizes or types of implants without having to reconfigure or readapt the apparatus. For example, implants with different maximum outer cross-sectional dimensions may be used in the multiple-implant deli y en' apparatus. The different sizes or types of implants may be implanted during a single procedure at a single time or in separate procedures at separate times. For example, if desired, a multiplicity of implants having different flow capacities and / or sizes may be implanted.

[0270] Although the implant insertion apparatus 200 has been described herein yvith respect to delivery of ocular implants yvithin internal eye tissue, the implant insertion apparatus 200 could be used or adapted to deliver other types of implants within the body.VII. Additional Examples of an Implant Insertion Apparatus

[0271] Figures 14A through 14E depict an embodiment of an implant insertion apparatus 200’, yvhich can have substantially the same elements and features of other implant insertion apparatuses disclosed herein, unless described otherwise.

[0272] Figure 14B depicts an embodiment of a design for a sliding trigger 214’ which can have features substantially similar to other embodiments of a sliding trigger described herein. In some embodiments, the sliding trigger 214’ can be configured such that the application of pressure in a direction substantially perpendicular to the direction that the sliding trigger 214’ travels within a trigger track 248 can deform the sliding trigger214’, or otherwise modify the position of the sliding trigger 214’ relative to the implant insertion apparatus 200’.

[0273] In some embodiments, the sliding trigger 214’ can deform at a deformation zone 215. In some embodiments, the deformation zone 215 can be located between where the trigger is contacted by an operator and where the trigger interfaces with the trigger tracks 248. In some embodiments, the sliding trigger 214' can include multiple materials such that the material of the trigger in a deformation zone 215 is more likely to bend than material in other portions of the sliding trigger 214’ when a force is exerted on the sliding trigger 214’. In some embodiments, cuts or other relief features can be made in the deformation zone 215 to facilitate deformation of the sliding trigger 214’ during operation.

[0274] In some embodiments, the sliding trigger 214’ may have more or less trigger track protrusions 216 than other trigger embodiments disclosed herein. In some embodiments, the location and quantify of trigger track protrusions 216 on a sliding trigger 214’ can be configured to allow the sliding trigger 214’ to move relative to the implant insertion apparatus 200’ in a direction substantially perpendicular the path the sliding trigger 214’ travels within the trigger track 248 when the sliding trigger 214’ is depressed.

[0275] By way of example, the embodiment of the sliding trigger 214’ in Figure 14B depicts a sliding trigger 214' with only three trigger track protrusions 216, such that one of the distal ends of the sliding trigger 214’ does not have a trigger track protrusion 216 to interface with a trigger track 248. In some embodiments, the sliding trigger 214’ can rotate or otherwise buckle in an expected manner to move vertically, or in some direction other than the path defined by the trigger track 248, within an implant insertion apparatus 200 ’ due to the configuration of the trigger track protrusions 216 on the sliding trigger 214’ .

[0276] In some embodiments, a portion of the sliding trigger 214’ can operate similar to the trigger spring 364 as described herein. This portion 364’of the sliding trigger 214’ can include a trigger spring bend 365’ and a trigger spring stop 366’ which can operate similarly to the trigger spring 364. trigger spring bend 365, and trigger spring stop 366 as described elsewhere herein.

[0277] In some embodiments, the sliding trigger 214’ includes a connection 217 portion that interfaces with the implant assembly 300’. In some embodiments, the sliding trigger 214’ is configured such that movement of the sliding trigger 214’ within the external housing 202 of an implant insertion apparatus 200’ can also move one or more components of an implant assembly 300 connected to the sliding trigger 214’ at the connection 217. Insome embodiments, the sliding trigger 214' can connect to the implant assembly 300 by one or more methods as described otherwise herein.

[0278] Figures 14C through 14E illustrate a sectional-view of the right housing portion 203B of an external housing 202 and a sliding trigger 214’ as the sliding trigger 214’ moves through various configurations according to one embodiment. Portions of the right housing portion 203B, such as the snap-fit engaging members 246 and trigger stop 249 are visible in these figures. Figure 14C depicts the sliding trigger 214’ in a first configuration. Figure 14D depicts the sliding trigger 214’ in a second configuration, and Figure 14E depicts the sliding trigger 214’ in a third configuration. In some embodiments, as the sliding trigger 214’ moves from the first configuration to the second configuration and / or to the third configuration, the trigger track protrusions 216 move along a path defined by the trigger track 248. In some embodiments, the trigger spring portion 364’ is generally relaxed when in the first configuration, and generally under some stress or load when in the second configuration and / or the third configuration.

[0279] In some embodiments, the trigger spring 364’ can be sized and dimensioned to limit lateral movement of the sliding trigger 214’ within the external housing 202, yet allow for limited proximal movement of the sliding trigger 214’.

[0280] In some embodiments, the trigger spring 364’ can provide a feedback to the user based on the position of the sliding trigger 214 similar to other embodiments of trigger spring 364 disclosed herein. In some embodiments, as the sliding trigger 214’ is moved from its first configuration to its second configuration, the trigger spring 364’ can interact with a trigger stop 249. The trigger spring 364’ can have a ramped portion, curved portion, or otherwise trigger spring bend 365’ which would make contact or otherwise interact with a trigger stop 249 on the external housing 202. In some embodiments, the trigger spring 364’ and / or the trigger spring bend 365’ can be made of a ferromagnetic material, and the trigger stop 249 can have apply a magnetic force to the trigger spring bend 365’ once the sliding trigger 214’ moves closer to the trigger stop 249 when moving between the first and second configuration.

[0281] In some embodiments, the feedback provided to the user can be a physical feedback (e.g., force-feedback or haptic feedback). In some embodiments, the physical feedback can come from the trigger spring bend 365’ making contact with the trigger stop 249. In some embodiments, the feedback can be an auditory' feedback, such as a clicking sound made by the trigger spring 364’ contacting the trigger stop 249. In some embodiments, the feedback can be a resistance to further movement of the sliding trigger214’. In some embodiments, the resistance to further movement can only be present if the trigger is moved in a first direction; if the trigger is moved in a second direction which is different than the first direction, the resistance to further movement may not be present, or may be present in varying degree.

[0282] In some embodiments, the trigger spring can require a second motion to advance the sliding trigger 214' from a second configuration to a third configuration. In some embodiments, the sliding trigger 214’ may need to be pushed vertically once the sliding trigger 214 is in the second position to transition the sliding trigger 214’ from its second configuration to its third configuration. In some embodiments, the sliding trigger 214’ may need to be rotated along an axis passing substantially through the implant insertion apparatus 200’ once the sliding trigger 214’ is in the second position to transition the sliding trigger 214’ from its second configuration to its third configuration.

[0283] Figure 14E illustrates the sliding trigger 214’ and trigger spring 364’ in the third configuration. In some embodiments, the trigger spring 364’ can deform or otherwise change dimensions such that the trigger spring bend 365’ can move past the trigger stop 249 when the trigger spring portion 364’ moves between the second configuration and the third configuration. In some embodiments, the trigger spring 364’ can deform vertically around the trigger stop 249. When in the third configuration, the sliding trigger 214’ is prevented from further movement by the trigger spring stop 366’ of the trigger spring 364’ interfacing with the trigger stop 249.

[0284] In some embodiments, the sliding trigger 214’ can deform to allow the trigger to move between its second and third configuration. In some embodiments, portions of the sliding trigger 214’ can deform or rotate relative to the path defined by the trigger track 248 and the trigger track protrusions 216. In some embodiments, the trigger spring portion 364’ can provide feedback and limit the range of motion of the sliding trigger 214’ similar to the trigger spring 364 and sliding trigger 214 as described herein.

[0285] In some embodiments, the sliding trigger 214’ can be dimensioned and have trigger track protrusions 216 positioned such that the sliding trigger 214’ can be manipulated when in a second configuration to move it to a third configuration. In some embodiments, the sliding trigger 214’ may need to be deformed or otherwise changed to move it from a second configuration to a third configuration.

[0286] In some embodiments, the sliding trigger 214’ can be moved perpendicularly relative to an axis passing substantially through the implant assembly 300’, such that the sliding trigger 214’ can be moved laterally within the implant insertionapparatus 200’. In some embodiments, a portion of the sliding trigger 214’ may need to be tilted relative to the implant insertion apparatus 200’ to transition from the second configuration to the third configuration. In some embodiments, a portion of the sliding trigger 214’ may need to be rotated relative to the implant insertion apparatus 200’ to transition from the second configuration to the third configuration.

[0287] In some embodiments, the opening 212 in the external housing 202 of the implant insertion apparatus 200’ can be modified to facilitate the movement of the sliding trigger 214’ between its second configuration and its third configuration. In some embodiments, the opening 212 can form a zig-zag shape where the direction change corresponds with the feedback indicating that the trigger needs to move from its second configuration to its third configuration. In some embodiments, the opening 212 can double back at the point where the trigger is at its second configuration. In some embodiments, the opening 212 can otherwise accommodate the path that the sliding trigger 214’ takes to convert from the first configuration to the second configuration and the second configuration to the third configuration.

[0288] Figures 15A through 15C depict an embodiment of a collet holder assembly 358’ designed to retain the implant assembly 300’ within the implant insertion apparatus 200’. The collet holder assembly 358’ can include a collet holder 360’ and a collet holder key 362'. In some embodiments, the sliding trigger 214’ can functionally connect to the implant assembly 300 such that movement of the sliding trigger 214’ within the external housing 202 moves one or more components of the implant assembly 300.

[0289] In some embodiments, the collet holder 360’ can align a portion of the tube set assembly 350 with the external housing 202. In some embodiments, the collet holder key 362’ can position the collet holder 360’ within the external housing 202 to restrain movement of some components of the tube set assembly 350 within the external housing 202.

[0290] In some embodiments, the collet holder 360’ can be secured in the proximal-distal direction within the implant insertion apparatus 200’ by a collet holder key 362’ which can interface with a collet holder interface 225 in the external housing 202 and a slot 352 in the tube set assembly 350.

[0291] Figure 15B depicts a partially transparent collet holder 360’ and collet holder key 362’ to illustrate the placement of the slot 352 within the tube set assembly 350.

[0292] Figure 15C depicts a cross section of the tube set assembly 350 and collet holder 360’. The collet holder interface 225 can be positioned in either of the left and right housing portions 203A, 203B of the external housing 202.

[0293] In some embodiments, the collet holder key 362’ can retain the collet holder 360' by passing through the slot 352 formed in one or more members of the tube set assembly 350 and the collet holder 360'.

[0294] Alternatively, or in addition, the collet holder key 362’ can be glued, sintered, welded, or otherwise permanently or non-permanently attached to the collet holder 360’. In some embodiments, the collet holder 360’ and the collet holder key 362’ can form a unitary body.

[0295] In some embodiments, the collet holder assembly 358’ can align the tube set assembly 350 within the external housing 202. In some embodiments, the collet holder assembly 358 can restrain the distal-proximal movement of the backing rod 370. In some embodiments, the collet holder assembly 358’ can connect the left and right housing portions 203A, 203B.

[0296] In some embodiments, the members of the tube set assembly 350. such as the backing rod 370 and the introducer tube 380 have slots or openings in them sized to allow movement of the sliding trigger 214’ relative to the implant insertion apparatus 200’.

[0297] Figures 16A through 16F depict potential embodiments of collet 390 designs.

[0298] Figures 16A and 16B depict a collet 390 that is a unitary body. In some embodiments, the collet arms 394 of the collet 390 can form a unitary body and integrally form a unitary' body on the proximal end of the collet 390. In some embodiments, openings 392 in the main body of the collet 390 may extend along the proximal-distal direction to separate the collet arms 394 such that they can move independent of each other.

[0299] Figures 16C and 16D depict two collet parts 391 that can form collet 390 when connected. In some embodiments, a collet 390 can be formed of two or more bodies that are attached to the backing rod 370. In some embodiments, there can be two collet parts 391. by bending a portion of the collet 390 to interface with corresponding portions of a backing rod 370 at a collet bend 398.

[0300] As described herein, the collet halves 391 can be stamped from metal sheets and formed to have geometry corresponding with openings 392, collet arms 394, and collet protrusions 396 corresponding to other collets 390 as disclosed herein. The multiplepieces can then be attached to a backing rod 370, and be biased radially outward so the collet halves 391 can operate as a collet 390 as described herein.

[0301] Figure 16E and Figure 16F depict an embodiment of a collet 390’ which was stamped from a metal sheet. The collet 390’ can have features substantially similar to other collets 390 described herein. In some embodiments, the collet bends 396’ can perform functions substantially similar to the collet protrusions 396 as described otherwise herein. The collet bends 396’ that interface with the retaining portion 320 of an implant 310 can be angled relative to the retaining portion 320. In some embodiments, angling the collet bends 396’ can improve the hold strength on the implant 310. In some embodiments, the collet bends 396’ can contact the retaining portion 320 in one or more positions. In some embodiments, the collet arms 394’ can have rippled or textured collet bends 396’ such that the collet 390’ contacts the implant 310 at the retaining portion 320 at multiple positions.

[0302] Figure 17A through Figure 17C illustrate potential embodiments of collets, graspers, or other retention and delivery members 1390 which can be used in an implant insertion apparatus (e.g.. implant insertion apparatus 200) as descnbed herein. The collet 1390 can have features substantially similar to other collets (e.g., collet 390) described herein. In some embodiments, the collet grips 1396 that interface with the retaining portion 320 of an implant 310 can be angled relative to the retaining portion 320. In some embodiments, the collet 1390 can connect to the backing rod 370 by use of one or more collet tabs 1398 on the proximal end portion of the collet 1390. The collet 1390 can be formed of two or more collet pieces 1391 positioned around or adjacent the backing rod 370. In some embodiments, the collet 1390 can be formed from sheet metal, and can have a thickness of approximately two thousandths of an inch. However, other materials and dimensions may be used as desired and / or required.

[0303] In some embodiments, the collet 1390 can have a first bend or arc 1395 and a second bend or arc 1397 configured to increase the pressure exerted by the collet grips 1396 on the implant 310 when in the first configuration or the second configuration (e.g., when the implant apparatus is entering the eye and when the implant is primed for deployment). In some embodiments, the first bend 1395 can curve the distal end of the collet halves 1391 (e.g., tines) in a convex direction (e.g., radially inward) such that the collet grips 1396 exert greater force on the retaining portion 320 than if the first bend 1395 were in the concave direction (e.g.. radially outward) or straight. In some embodiments, the force exerted due to the first bend 1395 assists in retaining the retaining portion 320 whenthe implant insertion apparatus 200 is in the second configuration. In some embodiments, the angle, arc, or radius of curvature of the first bend 1395 can be approximately equal the angle, arc or radius of curvature of the second bend 1397 in the opposite direction. In some embodiments, the second bend 1397 can bias the collet 1390 in a radially outward direction. In some embodiments, when arranged on the backing rod 370, the angle between the tips of the collet halves 1391 and the centerline defined by the backing rod 370 may be between 5 degrees and 20 degrees, between 5 degrees and 15 degrees, between 10 degrees and 20 degrees, overlapping ranges thereof, approximately 10 degrees, or any other value within the recited ranges. In some embodiments, the bends or arcs are transverse to a longitudinal direction of the implant.

[0304] Figure 18A through Figure 18G depict various views of an embodiment of an implant insertion apparatus 1200. The implant insertion apparatus 1200 can be substantially similar (e.g., include structural and / or operational features similar) to other insertion apparatuses described herein. In some embodiments, the implant insertion apparatus 1200 can include a sliding trigger 1230 and an implant assembly 1300 such as shown and described herein. The implant insertion apparatus 1200 can include an implant assembly 1300 that extends from the cone 205 of the apparatus. In some embodiments, the implant insertion apparatus 1200 can be used to implant and / or remove one or more implants from an eye. In some embodiments, the implant insertion apparatus 1200 can be used to implant and / or remove one or more implants from elsewhere in a patient.

[0305] Figure 19 depicts an exploded perspective view of the implant insertion apparatus 1200, showing the left housing portion 1203 A, the right housing portion 1203B, the trigger lock 290, and the trigger assembly 1210. Similar to other implant insertion apparatuses described herein, the implant insertion apparatus 1200 can be formed of a left housing portion 1203 A and a right housing portion 1203B which are substantially similar to the left housing portion 203A and right housing portion 203B described, and / or other housings described herein.

[0306] Figure 20 and Figure 21 depict the internal components of the implant insertion apparatus 1200, including the trigger assembly 1210 and a trigger lock 290 according to one embodiment. The trigger assembly 1210 can include a sliding trigger 1230, a backing member 1250, and an implant assembly 1300. The sliding trigger 1230 can move proximally and distally within the implant insertion apparatus 1200 between a first configuration, a second configuration, a third configuration, and a fourth configuration.When installed, the trigger lock 290 can prevent or substantially prevent movement of the sliding trigger 1230 within the implant insertion apparatus 1200.

[0307] In some embodiments, the sliding trigger 1230 can include a trigger portion 1231 that partially extends beyond the housing 202 of the implant insertion apparatus 1200. The trigger portion 1231 is designed to be manipulated by a user or operator to convert the implant insertion apparatus 1200 between the various configurations. The sliding trigger 1230 can be suspended within the housing 202 by trigger handpiece protrusions 1236 that move within the trigger track 248, which can be similar to how trigger track protrusions 216 move within a trigger track 248 according to other embodiments described herein. The sliding trigger 1230 can include a trigger spring 1234 configured to provide feedback (e.g.. audible and / or tactile feedback) to the user or operator as it is moving between the configurations. Lateral movement of the sliding trigger 1230 within the housing 202 can also move an introducer tube 1380 relative to the housing 202, to deploy an implant. The sliding trigger 1230 can include a trigger lever 1238 positioned between the trigger portion 1231 and the trigger handpiece protrusions 1236 such that pressing on the trigger portion 1231 can flex a portion of the sliding trigger 1230 relative to the housing 202. In some embodiments, the trigger spring 1234 can press against a portion of the backing member 1250 as the sliding trigger 1230 moves between configurations, and provide feedback (e.g., audible and / or tactile feedback) to the user or operator.

[0308] In some embodiments, the backing member 1250 can be positioned to be fixedly attached within the housing 202 such that the backing member 1250 doesn’t move relative to the housing 202 during use of the implant insertion apparatus 1200. The backing member 1250 can be arranged within the housing 202 by a plurality of backing member protrusions 1256 arranged along both directions. The backing member 1250 can include a spring backing surface 1252 designed to interact with the trigger spring 1234 as the sliding trigger 1230 moves between the configurations, as described further herein. In some embodiments, the backing rod 370 of the implant assembly 1300 can be retained within the implant insertion apparatus 1200 by a retention spring 1258 that passes at least partially through one or more components of the implant assembly 1300 and a slot in the backing rod 370. The retention spring 1258 can pass through a slot in the backing rod 370 to prevent or substantially prevent its movement relative to the housing 202.

[0309] The implant assembly 1300 can include one or a plurality of tubes configured to operatively work together to eject and withdraw an implant during aprocedure, and can operate substantially similar to other implant assemblies described herein. The implant assembly 1300 can be slidably connected to the backing member 1250 of the trigger assembly 1210 at a connection point 1257 and fixedly attached to the sliding trigger 1230 at a connection point 1239, such that movement of the sliding trigger 1230 also moves at least a portion of the implant assembly 1300. The implant assembly 1300 can be connected to the backing member 1250 and / or positioned within the housing 202 by a collet holder 360. In some embodiments, the collet holder 360 can align a portion of the implant assembly 1300 within the external housing 202.

[0310] In certain embodiments, the implant insertion apparatus 1200 is disposable or configured for a single use and includes one or more safety mechanisms that prevent reuse. For example, the safety mechanism can be an internal component that renders the instrument inoperable if re-sterilized. In accordance with several embodiments, the safety mechanism is that plastic parts do not survive sterilization with an autoclave. In some embodiments, the implant insertion apparatus 1200 is preloaded with an implant 310 upon being provided in a kit. In other embodiments, the implant insertion apparatus 1200 is reloaded with implants, sterilized, and re-used on the same or a different patient.

[0311] Figure 22A through Figure 25C depict operation of an implant insertion apparatus 1200 during an implantation process and / or removal of an implant from an eye.

[0312] Figure 22A through Figure 22C depict an implant insertion apparatus 1200 in a first configuration, where the implant can be preloaded within the implant insertion apparatus 1200. In some embodiments, movement of the sliding trigger 1230 in a proximal direction is partially resisted by interaction between the spring backing surface 1252 and the trigger spring 1234. As the sliding trigger 1230 moves distally, the force exerted by the trigger spring 1234 onto the backing member 1250 can increase until the trigger spring 1234 passes over the spring backing surface 1252, and the sliding trigger 1230 moves to the second configuration. When in the first configuration, the trigger spring 1234 can be in a relaxed state. When in the first position, movement of the sliding trigger 1230 in the distal direction can be substantially prevented by the sliding trigger 1230 pressing against the proximal-most part of the backing member 1250 and / or the housing 202. As the sliding trigger 1230 moves from the first configuration to the second configuration, the trigger pin 1232 can press against the lower surface of the peg 1254 extending from the backing member 1250 such that the trigger portion 1231 is forced downwards along the sloped pathway 1253. This can further increase the force exerted bythe trigger spring 1234 against the backing member 1250, and provide feedback to the user or operator in the form of the trigger portion 1231 moving downwards within the housing 202.

[0313] When in the first configuration, all or substantially all of the implant 310 is positioned within the interior of the introducer tube 380 such that the implant connection end 316 does not or does not substantially extend from the introducer tube 380. When in the first configuration, the implant 310 is firmly held by the collet grips 1396, as both the first bend 1395 and the second bend 1397 interact with the introducer tube 380 to exert a retaining force on the implant 310.

[0314] Figure 23A through Figure 23C depict an implant insertion apparatus 1200 in a second configuration, where the implant has been prepared for implantation within the eye tissue. Moving from the first configuration to the second configuration can require bending of the trigger spring 1234 into its deformed state as show n in Figure 23A. When in the second configuration, the trigger spring 1234 drops off the spring backing surface 1252 such that movement from the second to the first configuration is prevented by the backing member 1250.

[0315] When in the second configuration, the user or operator can receive feedback (e.g., tactile and / or audible feedback) from the implant insertion apparatus 1200 by the trigger pin 1232 being positioned in a crevice between the end of the sloped pathway 1253 and the beginning of the arched pathway 1255 along the path defined by the backing member 1250. Movement of the sliding trigger 1230 in the distal direction can be prevented or substantially prevented by contact of the distal end of the trigger spring 1234 against a surface of the backing member 1250. Movement of the sliding trigger 1230 in the proximal direction can be resisted by the trigger pin 1232 contacting the arched pathway 1255 of the backing member 1250, providing feedback (e.g., tactile feedback) to the user or operator. In some embodiments, portions of the arched pathway 1255 and / or the connection 1257 can be made of a ferromagnetic material, and the trigger pin 1232 can be a permanent magnet such that the magnetic force exerted by the trigger pin 1232 also provides feedback to the user or operator.

[0316] The deformation of the trigger spring 1234 as shown in Figure 23A can maintain the trigger portion 1231 in its depressed state and the trigger lever 1238 in its downwards-bent shape. When moving from the second configuration to the third configuration, this force can be released such that when in the third configuration, thetrigger spring 1234 and the trigger lever 1238 return or substantially return to their resting state.

[0317] When in the second configuration, the implant 310 can be partially exposed from the distal end of the introducer tube 380 such that an implant connection end 316 extends beyond the distal end of the introducer tube 380. When in the second configuration, the implant 310 can be less firmly held by the collet grips 1396 than in the first configuration. In the second configuration, the first bend 1395 can extend partially out from the introducer tube 380, which can reduce the gripping strength on the implant 310. However, the second bend 1397 can exert a force against the introducer tube 380 to retain the implant 310. When in the second configuration, the implant connection end 316 can be inserted into a tissue of an eye such that, when the implant 310 is released by the implant insertion apparatus 1200 by moving into the third configuration, the implant 310 is separated from (e.g., released from the grasp of) the collet 1390.

[0318] Figure 24A through Figure 24C depict an implant insertion apparatus 1200 in a third configuration, where the implant has been released from the implant insertion apparatus 1200. When moving from the second configuration to the third configuration, the trigger portion 1231 moves upward as the trigger pin 1232 rides along the arched pathway 1255. Simultaneously, the trigger spring 1234 can revert or substantially revert to its uncompressed state, as shown in Figure 24A. The user or operator receives feedback (e.g., audible and / or tactile feedback) from the sliding trigger 1230 that it has reached its third configuration by having the trigger pin 1232 contact the back surface of the backing member 1250 adjacent the arched pathway 1255. This back surface can prevent or substantially prevent further movement of the introducer tube 380 and sliding trigger 1230. Once in the third configuration, the sliding trigger 1230 can return to the second configuration if required, such as to reseat an implant 310 if it failed to properly attach to an eye tissue.

[0319] When in the third configuration, the collet grips 1396 have released the implant 310 from the implant insertion apparatus 1200. Once in the third configuration, a spent implant can also be removed from the eye without needing to remove the implant assembly 1300 from the eye. The implant assembly 1300 in the third configuration can be maneuvered to a spent implant in eye tissue at a second implant location and changed into the fourth configuration to grasp the implant to remove it. When in the third configuration, both the first bend 1395 and the second bend 1397 in the collet portions (e.g., halves) 1391are beyond the introducer tube 380, such that neither bends exert forces against the introducer tube 380.

[0320] Figure 25A through Figure 25C depict an implant insertion apparatus 1200 in a fourth configuration, where a spent implant had been grabbed for removal from the eye. In the fourth configuration, the trigger portion 1231 moves upward within the housing 202 and the trigger pin 1232 moves along an upper surface of the backing member 1250 to be above the peg 1254 in the backing member 1250. When moving from the third configuration to the fourth configuration, the trigger portion 1231 can be lifted relative to the housing 202. In accordance with several embodiments, this design can advantageously prevent inadvertent movement from the third configuration to the fourth configuration, and can intentionally require adjustment of a grip by the operator or the use of multiple hands. Once in the fourth configuration, the trigger portion 1231 can be moved either back to the first configuration to house the spent implant within the introducer tube 380, or to the third configuration to re-grasp the spent implant if it was not firmly grasped by the collet grips 1396.

[0321] When in the fourth configuration, the spent implant can be grasped similarly to how the implant 310 was initially grasped in the second configuration. The collet grips 1396 can grasp the spent implant at portions along its length similar to how they grasp the retaining portion 320 on the implant 310. In some embodiments, the spent implant can be similar to or identical to any implant described herein. The collet grips 1396 can grasp the spent implant at a retaining portion 320 and exert sufficient force on the implant such that the spent implant can be removed from the eye tissue.

[0322] In some embodiments, when in the fourth configuration and moving to the first configuration, the implant can be implanted in another part of the eye. This can be useful if a non-spent implant was incorrectly implanted in one part of the eye but needed to be either moved somewhere else or the implant insertion apparatus 1200 needed to be completely removed from the eye during a procedure. The implant insertion apparatus 1200 can grasp the implant by moving from the third to the fourth configuration, the introducer tube 1380 can be advanced over the implant to cover it for insertion by moving from the fourth to the first configuration, and the implant insertion apparatus 1200 can be partially or entirely removed from the eye. Then, the implant insertion apparatus 1200 can be reinserted into the eye with the implant to continue the implantation procedure.

[0323] In some embodiments, the outer cylindrical surface of the introducer tube 380 can be treated to change the surface characteristics of the introducer tube 380 tofacilitate movement of the introducer tube 380 through the eye tissue during a surgical procedure. Figure 26A and Figure 26B depict two possible embodiments of an introducer tube 1380 with a surface feature 1384 on its outer surface. In some embodiments, the surface features 1384 can be cut into the introducer tube 1380 such that portions of the introducer tube 1380 have different thicknesses. In some embodiments, the surface features 1384 can be arranged along the introducer tube 1380 in a radially symmetric pattern such that the surface of the introducer tube 1380 alternates between surface features 1384 and portions which are not treated by surface features. In some embodiments, the outer surface area of the introducer tube 1380 can be equally split between non-featured surface and surface features 1384. If an angled surface feature 1384 were angled relative to the length of the introducer tube 1380, the surface feature 1384 may have a pitch angle of 1 revolution per inch along the introducer tube 1380, 10 revolutions per inch along the introducer tube 1380, or any other pitch as desired or required. In some embodiments, custom patterns can be applied as a surface feature 1384 onto the introducer tube 1380. These custom patterns can include but should not be limited to: irregular patterns along the introducer tube 1380 such as dots along the length of or a portion of the introducer tube 1380, writing, spirals, straight lines, geometric shapes, non-linear arcs, slits, ridges, protrusions, recesses, or other patterns. The surface features 1384 in the introducer tube 1380 can be chamfered or filleted to reduce the sharpness of the transition betw een the standard introducer tube 1380 surface and the surface feature 1384.

[0324] In some embodiments, the outer surface of the introducer tube 1380 can be treated by one or more of the following methods, or with other methods, designed to reduce frictional forces (e.g., stiction) betw een the introducer tube 1380 and the eye during insertion: bead-blasting, sandblasting, chemical etching, laser texturing, micro-texturing, electropolishing, sanding, laser etching, machining, satin finishing, or the like. In some embodiments, multiple methods can be applied sequentially to the introducer tube 1380. In some embodiments, this surface treatment can be performed instead of, or in addition to, adding one or more surface features 1384 to the outer surface of the introducer tube 1380. In some embodiments, the outer surface of the introducer tube 1380 does not include a lubricious coating that may interact negatively or adversely with a drug (e.g., implant that includes a drug).

[0325] In some embodiments, the angled end 1382 of the introducer tube 1380 can have different profiles to prevent or reduce difficulty in inserting the introducer tube 1380 into the eye tissue. In some embodiments, the angled end 1382 can be sharpened tofacilitate entry into the cornea. In some embodiments, as shown in Figure 27A, the angled end 1382 can be angled at approximately 45 degrees relative to the longitudinal axis defined by the introducer tube 380. In some embodiments, the angled end 1382 can be angled further back, as shown in Figure 27B, such that the end 1386 of the opening is angled smaller than 45 degrees. This can facilitate entry of the introducer tube 1380 into the eye, by preventing or substantially preventing snagging of the end 1386 with the incision in the eye. In some embodiments, the angled end 1382 includes a constant angle relative to the longitudinal axis defined by the introducer tube 380. In some embodiments, the angled end 1382 varies in angle such that the angle at the distal end is different from the angle of a more-proximal portion of the angled end 1382.

[0326] In some embodiments as shown in Figure 27C and Figure 27D, the end1386 of the opening can be arched in a swept pattern such that, during insertion, the protrusion 1387 facilitates entry of the introducer tube 1380 into the eye tissue. The size and shape of the protrusion 1387 can reduce catching of any sag of the tissue from the incision to facilitate entry of the introducer tube 1380 into the eye. In some embodiments, the thickness of the introducer tube 1380 at or near the angled end 1382, or at any or all points of the introducer tube 1380, can be approximately 3.5 thousandths of an inch. In some embodiments, the protrusion 1387 can extend beyond the profile of the introducer tube 1380, such that when the introducer tube 1380 is inserted into the eye, the protrusion1387 moves the tissue surrounding the opening over the end 1386 to prevent or substantially prevent eye tissue being caught in the end 1386. In some embodiments, the implant assembly 1300 can be designed to provide the implant 310 to an implant zone through a smaller incision in the cornea (e g., less than 1 mm across).

[0327] Figure 28 depicts an embodiment of a introducer tube 1380 for use in an implant insertion apparatus 1200. The introducer tube 1380 can include an angled end 1382 that is sharpened such that the introducer tube 1380 can be self-trephinating or selftrephining (e.g., self-penetrating) such that an incision does not need to be made in an eye by a separate device before implantation of an implant 310 during a surgical procedure. The sharpened angled end 1382 can include a sharpened tip 1389 configured to pass through tissue without pre-forming an incision, hole or aperture. The sharpened forward end can be, for example, conical or tapered. The taper angle of the sharpened end can be, for example, about 30°±15° in some embodiments. The radius of the tip can be about 70 to about 200 microns (e.g., 70 to 100 microns, 90 to 160 microns, 100 to 200 microns, 100 to 180 microns, 150 microns to 200 microns, overlapping ranges thereof, or any value withinthe recited ranges). In some embodiments, the introducer tube 1380 may not be sharpened or beveled (e.g.. self-trephinating or self-trephining). Thus, the “garage door" feature described may be implemented for an introducer tube that is not sharpened in some embodiments. The distal end of the introducer tube 1380 may be angled or non-angled. Where an outlet opening is formed at the distal end of the implant, the distal portion can gradually increase in cross-sectional size in the proximal direction, preferably at a generally constant taper or radius or in a parabolic manner.

[0328] In some embodiments, the introducer tube 1380 can further include a retention flap, pin, door, or other member 1388 configured to direct eye tissue away from the opening in the introducer tube 1380. The retention flap 1388 may act or function as a “garage door’ feature. In some embodiments, the retention flap 1388 hingedly covers a distal end of the introducer tube 1380. The retention flap 1388 can be integrally formed with the introducer tube 1380 and be angled downward such that at least a portion of the distal opening in the introducer tube 1380 is covered by the retention flap 1388. During insertion, the retention flap 1388 can direct tissue away from the opening in the introducer tube 1380 to prevent or reduce the chance of snagging of the tissue (e.g.. eye tissue on the edges or notches of the opening of the angled end 1382.

[0329] In some embodiments, the retention flap 1388 can advantageously assist in retaining an implant 310 within the introducer tube 1380. The retention flap 1388 can be angled downwards to interfere with movement of the implant 310 out from the distal end of the introducer tube 1380. In embodiments of an implant insertion apparatus 1200 utilizing a introducer tube 1380 with a retention flap 1388, the retention flap 1388 can prevent or substantially prevent the implant 310 from accidentally or prematurely being expelled from the implant insertion apparatus 1200. Once sufficient force is exerted against the introducer tube 1380 such that the introducer tube 1380 is withdrawn over the implant 310 held by the collet 1390 and at least a portion of the backing rod 370, the implant 310 can be expelled or otherwise released or delivered from the introducer tube 1380. In some embodiments, the retention flap 1388 can be configured such that the backing rod 370 prevents the retention flap 1388 from returning to its resting state until the introducer tube 1380 is returned to its initial state. In some embodiments, the retention flap 1388 can be configured to allow' a spent implant to be recaptured into the introducer tube 1380 during a surgical procedure.VIII. Kits and Additional Language

[0330] In some embodiments, an implant insertion apparatus can be provided for a surgical procedure to provide an implant to the eye tissue. In such cases, the implant insertion apparatus can come provided with the implant loaded wi thin the collet.

[0331] In some embodiments, an implant insertion apparatus can be provided for a surgical procedure to remove an old implant from the eye tissue. In such cases, the implant insertion apparatus can come with no implant provided within the collet and can function as an implant removal or implant repositioning device.

[0332] In some embodiments, an implant insertion apparatus can be provided for a surgical procedure to both provide an implant to the eye tissue and to remove an old implant from the eye tissue. In such cases, the implant insertion apparatus can come provided with the implant loaded within the collet.

[0333] According to some embodiments, a kit (e.g., system or collection of items for a common purpose) for addressing ocular disorders is provided. The term “kit” as used herein should be given its ordinary meaning and should include any system, grouping and / or collection of devices, systems, components, features, materials and / or the like provided for a common goal. In one embodiment, the kit comprises one or more of the following: a delivery' apparatus (such as the implant insertion apparatus 200 described herein), a plurality of implants (such as the implants 310 described herein), an incising member, and a sensor (such as a pressure sensor, an intraocular pressure sensor, an analyte sensor, a glucose sensor, or any other sensor configured for placement within an eye). In some embodiments, the implants are pre-loaded within or on the delivery apparatus during manufacture and assembly prior to shipping. In other embodiments, the implants are not pre-loaded. The kit can further comprise instructions for using the various devices, components and / or other features of the kit for a particular procedure or treatment protocol. For example, such instructions for use can include details regarding the order in which the devices, systems or other components are used, the duration of use and / or the like.

[0334] While certain embodiments of the disclosure have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel methods, systems, and devices described herein may be embodied in a variety of other forms. For example, embodiments of one illustrated or described implant can be combined with embodiments of another illustrated or described implant. Moreover, the implants described above can be utilized for other purposes. For example, the implants can be used to drain fluid from the anterior chamberto other locations of the eye or outside the eye. In some embodiments, the systems comprise various features that are present as single features (as opposed to multiple features). Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Multiple features or components are provided in some embodiments. Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not necessarily rawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and / or rearranged. Furthermore, various omissions, substitutions and changes in the form of the methods, systems, and devices described herein may be made without departing from the spirit of the disclosure.

[0335] Conditional language, for example, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and / or steps. Thus, such conditional language is not generally intended to imply that features, elements and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and / or steps are included or are to be performed in any particular embodiment. The section headings used herein are merely provided to enhance readability and are not intended to limit the scope of the embodiments disclosed in a particular section to the features or elements disclosed in that section. The terms “comprising,” “including,”, “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.

[0336] Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “advancing a delivery apparatus” include “instructing advancing a delivers’ apparatus.” The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” ‘‘greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers or an amount that is within less than or equal to 10% of the stated amount. For example, “about 1 millimeter” includes “1 millimeter.” Terms or phrases preceded by a term such as “substantially” or “generally” include the recited term or phrase. The term “generally” as used herein represents a value, amount, or characteristic that predominantly includes or tends toward a particular value, amount, or characteristic. For example, “substantially all of the length” includes “all of the length” and “generally relaxed” includes “relaxed.”

[0337] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

Claims

WHAT IS CLAIMED IS:

1. An implant insertion apparatus configured to deliver an implant for treating an ocular disorder, the apparatus comprising: an external housing comprising an opening on an upper side of the external housing; an implant insertion assembly configured to provide an implant to an implant location in an eye of a patient, the implant insertion assembly comprising a sliding trigger partially protruding through the external housing through the opening, a trigger spring, a backing member, and a tube set assembly; wherein the backing member comprises a collet on a distal end of the backing member, the collet configured to retain an implant, and an introducer tube, the introducer tube configured to at least partially house the collet when in a first configuration; wherein the collet comprises one or more collet arms with griping areas configured to retain the implant; wherein the backing member and the collet are slidably attached to the backing member, wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction moves the introducer tube in the first direction; wherein moving the sliding trigger in the first direction changes the tube set assembly from a first configuration to a second configuration; wherein moving the sliding trigger further in the first direction changes the tube set assembly from the second configuration to a third configuration; wherein the trigger spring provides a feedback to a user as the sliding trigger moves from the first configuration to the second configuration; wherein in the first configuration the collet retains the implant and substantially all of the implant is within the introducer tube; wherein in the second configuration the collet retains the implant and the implant is partially disposed beyond a distal end of the introducer tube; wherein in the third configuration the implant is released from the collet and the implant is free from the implant insertion apparatus.

2. The implant insertion apparatus of Claim 1, wherein moving the sliding trigger in a second direction substantially opposite the first direction changes the tube set assembly from the third configuration to a fourth configuration; and wherein in the fourth configuration the collet is closed and at least partially within the introducer tube3. The implant insertion apparatus of any of the preceding claims, wherein protrusions on the collet substantially prevent movement of the implant in the first direction when in the first configuration and the second configuration.

4. The implant insertion apparatus of any of the preceding claims, wherein protrusions on the collet substantially prevent movement of the implant in the second direction when in the first configuration and the second configuration.

5. The implant insertion apparatus of any of the preceding claims, further comprising a trigger lock which prevents movement of the sliding trigger in the first direction, wherein the trigger lock is configured to be removable from the implant insertion apparatus.

6. The implant insertion apparatus of any of the preceding claims, wherein the tube set assembly is at an angle relative to a longitudinal axis of the implant insertion apparatus.

7. The implant insertion apparatus of any of the preceding claims, wherein the implant further comprises a main body with a distal end and a proximal end, the distal end comprising an implant connection end. the implant connection end comprising a sharpened end configured to enter into a sclera of the eye adjacent to a Schlemm’s canal and a retaining portion configured to maintain the implant at the implant location, the main body comprising a reserv oir configured to contain a specific amount of a treatment fluid.

8. The implant insertion apparatus of any of the preceding claims, wherein a portion of the tube set assembly is dimensioned to pass through a 1 mm incision into an eye.

9. The implant insertion apparatus of any of the preceding claims, wherein the trigger spring is configured to bias the tube set assembly to the first configuration.

10. The implant insertion apparatus of any of the preceding claims, wherein the feedback is a physical or auditory feedback.

11. The implant insertion apparatus of any of the preceding claims, wherein the feedback is a resistance felt by the user.

12. The implant insertion apparatus of any of the preceding claims, wherein an outer surface of the introducer tube further comprises one or more surface features configured to reduce friction between the introducer tube and the eye.

13. The implant insertion apparatus of Claim 12, wherein the one or more surface features comprise recesses running along at least a portion of the introducer tube.

14. The implant insertion apparatus of Claim 12, wherein the one or more surface features are angled along a length of the introducer tube.

15. The implant insertion apparatus of Claim 12, wherein the one or more surface features comprises a pattern selected from the group comprising: irregular patterns along the introducer tube, writing, geometric shapes, non-linear arcs, or other patterns.

16. The implant insertion apparatus of any of the preceding claims, wherein a portion of the tube set assembly is configured to pierce a cornea of the eye.

17. The implant insertion apparatus of Claim 16, wherein a distal end of the introducer tube further comprises a protrusion configured to direct the pierced cornea away from the distal end of the introducer tube.

18. The implant insertion apparatus of any of the preceding claims, wherein a distal end of the introducer tube further comprises a protrusion configured to retain the implant during deployment.

19. The implant insertion apparatus of any of the preceding claims, wherein the introducer tube further comprises a curved distal portion configured to facilitate entry into an incision of the eye.

20. The implant insertion apparatus of any of the preceding claims, wherein the collet comprises two or more collet parts, wherein the two or more collet parts are connected to the backing member.

21. The implant insertion apparatus of Claim 20, wherein each of the collet parts is bent with a first bend and a second bend, the first bend and the second bend being in substantially opposite directions; wherein each of the collet parts retain the implant when in the first configuration by the first bend and the second bend pressing the collet parts into an inner surface of the introducer tube; and wherein each of the collet parts retain the implant when in the second configuration by the second bend pressing the collet parts into the inner surface of the introducer tube.

22. An implant insertion apparatus configured to deliver an implant for treating an ocular disorder, the apparatus comprising: an external housing comprising an opening on an upper side of the external housing; an implant insertion assembly configured to facilitate introduction of a distal portion of the implant insertion apparatus into an implant location in an eye of a patient, the implant insertion assembly comprising a sliding trigger partially protruding through the external housing through the opening, a trigger spring, and a tube set assembly; wherein the tube set assembly comprises a backing rod with a collet on a distal end of the backing rod. the collet configured to retain an implant, and an introducer tube, the introducer tube configured to restrain the collet when in a first configuration; wherein the collet comprises one or more collet arms with collet protrusions configured to interface with a collet interface portion of the implant; wherein the backing rod and the collet are fixedly attached to the external housing by a collet holder assembly, wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction moves the introducer tube in the first direction; wherein moving the sliding trigger in the first direction changes the tube set assembly from a first configuration to a second configuration; wherein moving the sliding trigger further in the first direction changes the tube set assembly from the second configuration to a third configuration; wherein the trigger spring provides a feedback to a user when the sliding trigger moves from the first configuration to the second configuration and prevents the sliding trigger from substantially moving beyond the third configuration; wherein in the first configuration the collet is closed around the implant and substantially all of the implant is within the introducer tube; wherein in the second configuration the collet is closed around the implant and implant is partially disposed beyond a distal end of the introducer tube; and wherein in the third configuration the collet is opened and the implant is free from the implant insertion apparatus.

23. The implant insertion apparatus of Claim 22, wherein the collet protrusions substantially prevent movement of the implant in the first direction when in the first configuration and the second configuration.

24. The implant insertion apparatus of any of Claims 22-23, further comprising a trigger lock which prevents movement of the sliding trigger in the first direction, wherein the trigger lock is configured to be removable from the implant insertion apparatus.

25. The implant insertion apparatus of any of Claims 22-24, wherein the tube set assembly is at an angle relative to a longitudinal axis of the implant insertion apparatus.

26. The implant insertion apparatus of any of Claims 22-25, wherein the implant further comprises a main body with a distal end and a proximal end, the distal end comprising an implant connection end. the implant connection end comprising a sharpened end configured to enter into a sclera of the eye adjacent to a Schlemm’s canal and a retaining portion configured to maintain the implant at the implant location, the main body comprising a reserv oir configured to contain a specific amount of a treatment fluid.

27. The implant insertion apparatus of any of Claims 22-26, wherein a portion of the tube set assembly is dimensioned to pass through a 1 mm incision into an eye.

28. The implant insertion apparatus of any of Claims 22-27, wherein the trigger spring is configured to bias the tube set assembly to the first configuration.

29. The implant insertion apparatus of any of Claims 22-28, wherein the feedback is a physical or auditory feedback.

30. The implant insertion apparatus of any of Claims 22-29, wherein the feedback is a resistance felt by the user.

31. The implant insertion apparatus of any of Claims 22-30, wherein the introducer tube further comprises a curved distal portion configured to facilitate entry into an incision of an eye.

32. An implant insertion apparatus configured to deliver an implant for treating an ocular disorder, the apparatus comprising: an external housing comprising an opening on an upper side of the external housing; an implant insertion assembly configured to facilitate introduction of a distal portion of the implant insertion apparatus into an implant location in an eye of a patient, the implant insertion assembly comprising a sliding trigger partially protruding through the external housing through the opening, a trigger spring, and a tube set assembly;wherein the tube set assembly comprises a backing rod with a collet on a distal end of the backing rod, the collet configured to retain an implant, and an introducer tube, the introducer tube configured to restrain the collet when in a first configuration; wherein the collet comprises one or more collet arms with collet protrusions configured to interface with a collet interface portion of the implant; wherein the backing rod and the collet are fixedly attached to the external housing by a collet holder assembly, wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction moves the introducer tube in the first direction; wherein moving the sliding trigger in the first direction changes the tube set assembly from a first configuration to a second configuration; wherein moving the sliding trigger in a second direction changes the tube set assembly from the second configuration to a third configuration; wherein the trigger spring provides a feedback to a user when the sliding trigger moves from the first configuration to the second configuration and prevents the sliding trigger from substantially moving beyond the third configuration; wherein in the first configuration the collet is closed around the implant and substantially all of the implant is within the introducer tube; wherein in the second configuration the collet is closed around the implant and implant is partially disposed beyond a distal end of the introducer tube; and wherein in the third configuration the collet is opened and the implant is free from the implant insertion apparatus.

33. The implant insertion apparatus of Claim 31, wherein the collet protrusions substantially prevent movement of the implant in the first direction when in the first configuration and the second configuration.

34. The implant insertion apparatus of any of Claims 32-33, further comprising a trigger lock which prevents movement of the sliding trigger in the first direction, wherein the trigger lock is configured to be removable from the implant insertion apparatus.

35. The implant insertion apparatus of any of Claims 32-34, wherein the implant further comprises a main body with a distal end and a proximal end, the distal end comprising an implant connection end. the implant connection end comprising a sharpened end configured to enter into a sclera of the eye adjacent to a Schlemm’s canal and aretaining portion configured to maintain the implant at the implant location, the main body comprising a reservoir configured to contain a specific amount of a treatment fluid.

36. The implant insertion apparatus of any of Claims 32-35, wherein a portion of the tube set assembly is dimensioned to pass through a 1 mm incision into an eye.

37. The implant insertion apparatus of any of Claims 32-36, wherein the trigger spring is configured to bias the tube set assembly to the first configuration.

38. The implant insertion apparatus of any of Claims 32-37, wherein the feedback is a physical or auditory feedback.

39. The implant insertion apparatus of any of Claims 32-38, wherein the feedback is a resistance felt by the user.

40. The implant insertion apparatus of any of Claims 32-39, wherein the introducer tube further comprises a curved distal portion configured to facilitate entry into an incision of an eye.

41. The implant insertion apparatus of any of Claims 32-40, wherein the collet is formed as a unitary body.

42. The implant insertion apparatus of any of Claims 32-41, wherein the collet comprises two or more parts.

43. The implant insertion apparatus of any of Claims 32-42, wherein the collet is formed from sheet metal.

44. The implant insertion apparatus of any of Claims 32-43, wherein the sliding trigger is configured to deform as it moves between the second configuration and the third configuration.

45. The implant insertion apparatus of any of Claims 32-44, wherein the opening is configured to direct movement of the trigger through the housing.

46. The implant insertion apparatus of any of Claims 32-45, wherein the first direction and the second direction are the same direction.

47. The implant insertion apparatus of any of Claims 32-46, wherein the first direction and the second direction are substantially different directions.

48. A method of treating an ocular disorder, comprising: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus comprising: an implant assembly comprising a sliding trigger and a tube set assembly, the tube set assembly comprising a backing rod with a collet containing an implant, the backing rod within an introducer tube;wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to a third configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at an implant location; advancing the implant assembly such that a distal end of the implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; and, partially withdrawing the implant insertion apparatus from the implant location.

49. The method of treating an ocular disorder of Claim 48, further comprising positioning the distal end of the implant assembly at a second implant location with a second implant; advancing the implant assembly such that the distal end of the implant assembly would partially surround the second implant; converting the implant insertion apparatus from the third configuration to the second configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the second configuration to the first configuration; and removing the implant insertion apparatus from the eye.

50. The method of treating an ocular disorder of any of Claims 48-49, further comprising confirming attachment of the implant to the implant location by tapping the implant with the distal end of the implant assembly.

51. The method of treating an ocular disorder of any of Claims 48-50, further comprising: partially withdrawing the distal end of the implant assembly from the implant location;converting the implant insertion apparatus from the third configuration to the second configuration, and from the second configuration to the first configuration; and withdrawing the implant insertion apparatus from the incision in the eye.

52. The method of treating an ocular disorder of any of Claims 48-51, wherein the method does not require use of viscoelastic.

53. The method of treating an ocular disorder of any of Claims 48-51. further comprising applying viscoelastic into the eye.

54. A method of treating an ocular disorder, comprising: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus comprising: an implant assembly comprising a sliding trigger and a tube set assembly, the tube set assembly comprising a backing rod with a collet containing an implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and moving the sliding trigger in a second direction converts the implant insertion apparatus from the second configuration to a third configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at an implant location; advancing the implant assembly such that a distal end of the implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; and, partially withdrawing the implant insertion apparatus from the implant location.

55. The method of treating an ocular disorder of Claim 54, further comprising positioning the distal end of the implant assembly at a second implant location with a second implant; advancing the implant assembly such that the distal end of the implant assembly would partially surround the second implant;converting the implant insertion apparatus from the third configuration to the second configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the second configuration to the first configuration; and removing the implant insertion apparatus from the eye.

56. The method of treating an ocular disorder of any of Claims 54-55, further comprising confirming attachment of the implant to the implant location by tapping the implant with the distal end of the implant assembly.

57. The method of treating an ocular disorder of any of Claims 54-56, further comprising: partially withdrawing the distal end of the implant assembly from the implant location; converting the implant insertion apparatus from the third configuration to the second configuration, and from the second configuration to the first configuration; and withdrawing the implant insertion apparatus from the incision in the eye.

58. The method of treating an ocular disorder of any of Claims 54-57, wherein the method does not require use of viscoelastic.

59. The method of treating an ocular disorder of any of Claims 54-57, further comprising applying viscoelastic into the eye.

60. A method of removing an implant from an eye, comprising: positioning at least a portion of an implant insertion apparatus when in a third configuration adjacent an implant at an implant location within an eye, the implant insertion apparatus comprising: an implant assembly comprising a sliding trigger and a tube set assembly, the tube set assembly comprising a backing rod with a collet containing an implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to the third configuration; abutting the backing rod against the implant;converting the implant insertion apparatus from the third configuration to a fourth configuration by moving the sliding trigger in a second direction substantially opposite the first direction; partially withdrawing the implant insertion apparatus from the implant location, wherein the implant has been removed from the implant location; and converting the implant insertion apparatus from the fourth configuration to the first configuration by moving the sliding trigger in the second direction.

61. A method of treating an ocular disorder, comprising: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus comprising: an implant assembly comprising a sliding trigger and a tube set assembly, the tube set assembly comprising a backing rod with a collet containing a first implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and moving the sliding trigger in a second direction converts the implant insertion apparatus from the second configuration to a third configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at a first implant location; advancing the implant assembly such that a distal end of the first implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; partially withdrawing the implant insertion apparatus from the first implant location; advancing the implant assembly such that the distal end of the implant assembly would partially surround a second implant, wherein the second implant is implanted at a second implant location; converting the implant insertion apparatus from the third configuration to the second configuration;partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location; converting the implant insertion apparatus from the second configuration to the first configuration; and removing the implant insertion apparatus from the eye.

62. A method of treating an ocular disorder, comprising: advancing at least a portion of an implant insertion apparatus through an incision in an eye, the implant insertion apparatus comprising: an implant assembly comprising a sliding trigger and a tube set assembly, the tube set assembly comprising a backing rod with a collet containing a first implant, the backing rod within an introducer tube; wherein the sliding trigger is operatively connected to the introducer tube such that moving the sliding trigger in a first direction converts the implant insertion apparatus from a first configuration to a second configuration and from the second configuration to a third configuration and moving the sliding trigger in a second direction converts the implant insertion apparatus from the third configuration to a fourth configuration and from the fourth configuration to the first configuration; converting the implant insertion apparatus from the first configuration to the second configuration; positioning a distal end of the implant assembly at a first implant location; advancing the implant assembly such that a distal end of the first implant partially enters a tissue of the eye; converting the implant insertion apparatus from the second configuration to the third configuration; partially withdrawing the implant insertion apparatus from the first implant location; advancing the implant assembly such that the distal end of the implant assembly would partially surround a second implant, wherein the second implant is implanted at a second implant location; converting the implant insertion apparatus from the third configuration to the fourth configuration; partially withdrawing the implant insertion apparatus such that the second implant separates from the second implant location;converting the implant insertion apparatus from the fourth configuration to the first configuration; and removing the implant insertion apparatus from the eye.

Images