Dosing dock for syringes

Abstract

The device includes a body, a flexible cannula, and a needle. The needle is resiliently biased to extend along at least one proximal curve through at least one proximal curved needle section. The needle is resiliently biased to extend along at least one distal curve through at least one distal curved needle section. In another embodiment, the device includes a body portion including a proximal channel configured to receive a syringe plunger and a stop surface configured to selectively engage the syringe plunger to prevent distal advancement of the plunger. The device also includes first and second deflectable beams configured to cooperate with each other to firmly grip the syringe barrel, and first and second deflectable flanges configured to cooperate with each other to grip the syringe barrel.

Description

[Technical Field]

[0001] Priority This application claims the benefit of U.S. Patent Application No. 63 / 438,929, filed January 13, 2023, entitled "Administration Dock for Syringes," the disclosure of which is incorporated herein by reference. [Background technology]

[0002] background The human eye contains several layers. The white outer layer is the sclera, which surrounds the choroid layer. The retina lies inside the choroid layer. The sclera contains collagen and elastic fibers and protects the choroid and retina. The choroid layer contains the vasculature, which provides oxygen and nutrients to the retina. The retina contains light-sensitive tissue, including rods and cones. The macula is located in the center of the retina at the back of the eye and is generally centered on an axis (i.e., the optical axis) that passes through the center of the eye's lens and cornea. The macula provides central vision, particularly via cone cells.

[0003] Macular degeneration is a medical condition that affects the macula, causing people with macular degeneration to experience loss or deterioration of central vision while retaining some peripheral vision. Macular degeneration can be caused by various factors, such as aging (also known as "AMD") and genetics. Macular degeneration can occur in a "dry" (non-exudative) form, in which cellular debris known as drusen accumulates between the retina and the choroid, resulting in areas of geographic atrophy. Macular degeneration can also occur in a "wet" (exudative) form, in which blood vessels grow from the choroid behind the retina. Even though people with macular degeneration may retain some peripheral vision, the loss of central vision can have a significant negative impact on quality of life. Furthermore, the quality of the remaining peripheral vision may be reduced and even eliminated. Therefore, it may be desirable to provide a treatment for macular degeneration to prevent or reverse vision loss caused by macular degeneration. In some cases, it may be desirable to provide such treatment in a highly localized manner, such as by delivering therapeutic agents to the subretinal layers (below the neurosensory layer of the retina and above the retinal pigment epithelium) immediately adjacent to the area of ​​geographic atrophy near the macula. However, because the macula is at the back of the eye and beneath the delicate layers of the retina, it can be difficult to access the macula in a practical manner.

[0004] Although various surgical methods and instruments have been made and used to treat the eye, it is believed that no one prior to the present inventors has made or used the present invention as set forth in the appended claims. [Brief explanation of the drawings]

[0005] While this specification concludes with claims particularly pointing out and distinctly claiming this technology, it is believed that this technology will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:

[0006] [Figure 1] FIG. 1 shows a perspective view of an example of an apparatus for subretinal administration of a therapeutic agent from a suprachoroidal approach.

[0007] [Figure 2] 2 shows a perspective view of the distal portion of the cannula of the instrument of FIG. 1.

[0008] [Figure 3] 3 shows a front view of the distal portion of the cannula of FIG. 2.

[0009] [Figure 4] 3 shows a top view of the distal portion of the cannula of FIG. 2.

[0010] [Figure 5] 3 shows a perspective view of the distal end of the cannula of FIG. 2 with a needle extending from the cannula.

[0011] [Figure 6] 2 shows a perspective view of the device of FIG. 1 worn near a patient with a combination of medical devices.

[0012] [Figure 7A] 1 shows a cross-sectional side view of a patient's eye.

[0013] [Figure 7B] 7B shows a side cross-sectional view of the eye of FIG. 7A with a suture loop attached to the eye and a sclerotomy performed.

[0014] [Figure 7C] 7B shows a side cross-sectional view of the eye of FIG. 7A with the cannula of FIG. 2 inserted between the sclera and choroid of the eye through a sclerotomy opening.

[0015] [Figure 7D] 7B shows a cross-sectional side view of the eye of FIG. 7A with the distal end of the cannula positioned adjacent to the target location.

[0016] [Figure 7E] 7B shows a side cross-sectional view of the eye of FIG. 7A with the needle of FIG. 5 advanced through the choroid to access the subretinal space at the target location.

[0017] [Figure 7F] 7A shows a cross-sectional side view of the eye of FIG. 7A in which the needle of FIG. 5 dispenses a first volume of pre-bleb fluid to create a separation between a region of the retina and the choroid at a target location.

[0018] [Figure 7G] 7B shows a side cross-sectional view of the eye of FIG. 7A, in which the needle of FIG. 5 dispenses a therapeutic agent between a region of the retina and the choroid at a target location.

[0019] [Figure 8] 1. FIG. 4 shows a perspective view of an alternative cannula that may be incorporated into the instrument of FIG. 1, the cannula having a varying stiffness along the length of the cannula.

[0020] [Figure 9] FIG. 9 shows a front view of the cannula of FIG. 8.

[0021] [Figure 10] FIG. 9 shows a side view of the cannula of FIG. 8.

[0022] [Figure 11] FIG. 9 shows a top view of the cannula of FIG. 8.

[0023] [Figure 12] 12 shows a cross-sectional view of the intermediate segment of the cannula of FIG. 8 taken along line 12-12 of FIG. 11.

[0024] [Figure 13] 13 shows a cross-sectional view of the distal segment of the cannula of FIG. 8 taken along line 13-13 of FIG. 11.

[0025] [Figure 14] 2 shows a side view of an alternative needle that may be incorporated into the device of FIG. 1, the needle having a proximal curve and a distal curve.

[0026] [Figure 15] 15 shows a side view of the distal end of the needle of FIG. 14.

[0027] [Figure 16] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having a proximal curve and a distal curve.

[0028] [Figure 17] FIG. 17 shows a side view of the distal end of the needle of FIG. 16.

[0029] [Figure 18] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having a proximal curve and a distal curve.

[0030] [Figure 19] FIG. 19 shows a side view of the distal end of the needle of FIG. 18.

[0031] [Figure 20] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having first and second proximal curves and a distal curve.

[0032] [Figure 21] 21 shows a side view of the distal end of the needle of FIG. 20.

[0033] [Figure 22] 21 shows a side view of the needle of FIG. 20 showing the first reference circle of the first proximal curve.

[0034] [Figure 23] 21 shows a side view of the needle of FIG. 20 showing the second reference circle of the second proximal curve.

[0035] [Figure 24] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having first and second distal curves.

[0036] [Figure 25] 25 shows a side view of the distal end of the needle of FIG. 24.

[0037] [Figure 26] 25 shows a side view of the needle of FIG. 24 showing the reference circle of the first distal curve.

[0038] [Figure 27] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having a proximal curve and first and second distal curves.

[0039] [Figure 28] 28 shows a side view of the distal end of the needle of FIG. 27.

[0040] [Figure 29] 10 shows a side view of another alternative needle that may be incorporated into the device of FIG. 1, the needle having first and second proximal curves and first and second distal curves.

[0041] [Figure 30] 30 shows a side view of the distal end of the needle of FIG. 29.

[0042] [Figure 31] 1 shows a perspective view of an example of a docking dock for use with a syringe.

[0043] [Figure 32] 32 shows a top view of the administration dock of FIG. 31.

[0044] [Figure 33] 32 shows a side view of the administration dock of FIG. 31.

[0045] [Figure 34] 32 shows a rear view of the administration dock of FIG. 31.

[0046] [Figure 35A] 32 shows a top view of the docking dock and syringe of FIG. 31 with the syringe separated from the docking dock and the syringe coupled to a fluid source.

[0047] [Figure 35B]35A shows a top view of the docking dock of FIG. 31 and the syringe of FIG. 35A, with the syringe separated from the docking dock and the syringe having fluid drawn from a fluid source.

[0048] [Figure 35C] A top view of the dosing dock of Figure 31 and the syringe of Figure 35A is shown, with the syringe coupled to the dosing dock while holding the withdrawn fluid of Figure 35B, and the shoulder of the syringe plunger spaced proximally from the stop surface of the dosing dock.

[0049] [Figure 35D] 35A shows a top view of the dosing dock of FIG. 31 and the syringe of FIG. 35A, with the syringe coupled to the dosing dock while holding the drawn fluid of FIG. 35B, with the shoulder of the syringe plunger spaced proximally from the stop surface of the dosing dock, and the syringe coupled to the device of FIG. 1.

[0050] [Figure 35E] 35A shows a top view of the dosing dock of FIG. 31 and the syringe of FIG. 35A, with the syringe coupled to the dosing dock, the syringe coupled to the device of FIG. 1, and the plunger of the syringe advanced distally to a first longitudinal position relative to the barrel of the syringe so that the shoulder of the plunger engages the stop surface of the dosing dock.

[0051] [Figure 35F] A top view of the administration dock of Figure 31 and the syringe of Figure 35A is shown, with the syringe separated from the administration dock and the syringe coupled to the device of Figure 1, with the syringe plunger remaining in a first longitudinal position relative to the syringe barrel.

[0052] [Figure 35G]35A shows a top view of the dosing dock of FIG. 31 and the syringe of FIG. 35A, with the syringe separated from the dosing dock, the syringe coupled to the device of FIG. 1, and the plunger of the syringe advanced distally to a second longitudinal position relative to the barrel of the syringe so that the shoulder of the plunger engages the stop surface of the barrel.

[0053] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be embodied in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the technology and, together with the description, serve to explain the principles of the technology. It will be understood, however, that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION

[0054] Detailed Description The following description of specific examples of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will be apparent to those skilled in the art from the following illustrative description of one of the best modes contemplated for carrying out the present technology. It is understood that the technology described herein is capable of other distinct and obvious embodiments, all without departing from the technology. Therefore, the drawings and descriptions should be considered to be illustrative in nature and not limiting.

[0055] It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from one another. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0056] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to the location of an element closer to the surgeon or other operator, and the term "distal" refers to the location of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0057] Furthermore, the terms "about," "approximately," and the like, as used herein in connection with any numerical value or range of values, are intended to encompass the exact value referenced, as well as an appropriate tolerance that enables the referenced feature or combination of features to function for the intended purpose described herein.

[0058] I. Devices for subretinal administration of therapeutic agents

[0059] 1 shows an example of an instrument (100) configured for use in a procedure for subretinal administration of a therapeutic agent to a patient's eye via a suprachoroidal approach. The instrument (100) includes a body (110) and a flexible cannula (130) extending distally from the body (110). The cannula (130) in this example has a generally rectangular cross-section, although any other suitable cross-sectional profile (e.g., oval, etc.) may be used. The generally rectangular cross-sectional profile of the cannula (130) is configured to allow the cannula (130) to pass atraumatically along the suprachoroidal space, as described in more detail below. The cannula (130) is generally configured to support a slidable needle (150) within the cannula (130), as described in more detail below.

[0060] In this example, the cannula (130) comprises a flexible material such as polyether block amide (PEBA), although any other suitable material or combination of materials may be used. In some versions, the cannula (130) has cross-sectional profile dimensions of approximately 1.6 mm (width) by approximately 0.6 mm (height) and a length of approximately 80 mm. Alternatively, any other suitable dimensions may be used. The cannula (130) of this example is flexible enough to conform to the particular anatomy and contours of a patient's eye, yet has sufficient column strength to allow advancement of the cannula (130) between the sclera and choroid of the patient's eye without buckling. As best seen in Figures 2-5, the cannula (130) includes a laterally oriented opening (134) near the distal end (132) of the cannula (130). The opening (134) in this example is formed by a U-shaped lateral recess (136) in the cannula (130) that leads to the open distal end (138) of a needle guide lumen in the cannula (130). The distal end (132) is atraumatic such that the distal end (132) is configured to effect separation between the scleral and choroidal layers via blunt dissection, as described in more detail below, thereby allowing the cannula (130) to be advanced between such layers without trauma to the scleral or choroidal layers.

[0061] By way of example only, cannula (130) may be configured and operable in accordance with at least some of the teachings of U.S. Pat. No. 10,226,379, issued March 12, 2019, entitled "Method and Apparatus for Subretinal Administration of Therapeutic Agents," the disclosure of which is incorporated herein by reference in its entirety, and U.S. Pat. No. 10,646,374, issued May 12, 2020, entitled "Apparatus and Method for Forming an Entry Bleb for Subretinal Delivery of Therapeutic Agents," the disclosure of which is incorporated herein by reference in its entirety and / or in any other suitable manner.

[0062] As shown in FIG. 5, the needle 150 may be advanced distally and protrude from the opening 134. The needle 150 in this example has a sharpened distal tip 152 and defines a lumen (not shown). The distal tip 152 in this example has a lancet configuration. In some other versions, the distal tip 152 has a tribevel configuration or any other configuration, such as that described in U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Still other suitable forms that the distal tip 152 may take will be apparent to those skilled in the art in view of the teachings herein. In this embodiment, as described in more detail below, when the cannula (130) is positioned within the suprachoroidal space, the generally rectangular, oval, or otherwise substantially flat cross-sectional shape of the cannula (130) prevents the cannula (130) from rotating about its longitudinal axis, as described in more detail below. This provides a consistent and predictable orientation of the opening (134), thereby providing a consistent and predictable exit path for the needle (150) as it advances distally relative to the cannula (130).

[0063] By way of example only, after needle 150 is advanced distally relative to cannula 130, the angle defined between the exposed portion of needle 150 and cannula 130 may be in the range of about 5° to about 30° relative to the longitudinal axis of cannula 130, or more specifically, in the range of about 5° to about 20° relative to the longitudinal axis of cannula 130, or more specifically, in the range of about 5° to about 10° relative to the longitudinal axis of cannula 130, and even more specifically, in the range of about 7° to about 9° relative to the longitudinal axis of cannula 130. In this embodiment, needle 150 is resiliently biased into a bent configuration, thereby providing an exit angle that varies based on the extent to which needle 150 is advanced distally relative to cannula 130. By way of further example only, needle (150) may include a preformed bend in accordance with at least some of the teachings of U.S. Patent No. 10,478,553, entitled "Subretinal Therapeutic Agent Administration Device Using a Curved Needle," issued November 19, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0064] As shown in FIG. 1 , the instrument (100) of this example further includes an actuation knob (120) disposed on the top portion (114) of the body (110). The actuation knob (120) is rotatable relative to the body (110) to selectively translate the needle (150) longitudinally relative to the cannula (130). In particular, the actuation knob (120) is rotatable in a first angular direction to drive the needle (150) distally relative to the cannula (130) and in a second angular direction to drive the needle (150) proximally relative to the cannula (130). By way of example only, the instrument (100) may provide such functionality via the knob (120) in accordance with at least some of the teachings of U.S. Pat. No. 10,646,374, the disclosure of which is incorporated herein by reference in its entirety. Other suitable manners by which rotational motion of knob (120) can be translated into linear movement of needle (150) will be apparent to those skilled in the art in view of the teachings herein. Similarly, other suitable manners by which needle (150) can be longitudinally actuated relative to cannula (130) will be apparent to those skilled in the art in view of the teachings herein. As also shown in FIG. 1 , conduit assembly (140) extends proximally from body (110). Conduit assembly (140) is configured to house one or more fluid conduits (not shown) that are in fluid communication with needle (150). In some versions, such fluid conduits are coupled to sources of primary bleb fluid and therapeutic agent.

[0065] II. Technique for delivering therapeutic agents to the subretinal space from the suprachoroidal approach

[0066] FIG. 6 illustrates a scenario in which the device (100) is positioned relative to a patient. In this example, a drape (12) is placed over the patient, and an opening (18) is formed in the drape (12) near the patient's eye (301). A speculum (16) is used to hold the eye (301) open. A retainer (14) is placed adjacent to the eye (301). The retainer (14) may be used to secure an instrument, such as a viewing scope, relative to the patient. A magnetic pad (30) is adhered to the drape (12) near the opening (18) adjacent the eye (301). The device (100) is placed on the magnetic pad (30) and removably secured thereto via magnetic attraction. In this example, one or more permanent magnets (not shown) are placed within the body (110) near the bottom (112), and these magnets are magnetically attracted to one or more iron elements (not shown) contained within the magnetic pad (30). By way of example only, these magnets and magnetic pads (30) may be configured in accordance with at least some of the teachings of U.S. Patent No. 10,806,629, issued October 20, 2020, and entitled "Injection Device for Subretinal Delivery of Therapeutic Agents," the disclosure of which is incorporated herein by reference in its entirety. The instrument (100) is oriented to allow insertion of the flexible cannula (130) of the instrument (100) into the eye (301). An example of a process for inserting and positioning the cannula (130) into the eye (301) is described in more detail below with reference to Figures 7A-7F.

[0067] In this example, instrument (100) is coupled to fluid delivery system (80) via conduit assembly (140). In this example, fluid delivery system (80) includes bleb fluid source (82) and therapeutic agent fluid source (84). Bleb fluid source (82) is coupled to bleb fluid conduit (142) of conduit assembly (140), and therapeutic agent fluid source (84) is coupled to therapeutic agent conduit (144) of conduit assembly (140). Conduits (142, 144) are in fluid communication with needle (150). In some versions, fluid sources (82, 84) include syringes. In other versions, fluid sources (82, 84) include separate reservoirs and one or more associated pumps and / or valves, etc.

[0068] 7A-7G illustrate an example of a procedure that may be performed using the aforementioned device to deliver a therapeutic agent to the subretinal space (301) of the eye from a suprachoroidal approach. By way of example only, the methods described herein may be used to treat macular degeneration and / or other ocular conditions. While the procedures described herein are discussed in the context of treating age-related macular degeneration, no such limitation is intended or implied. For example, in some alternative procedures, the same techniques described herein may be used to treat retinitis pigmentosa, diabetic retinopathy, and / or other ocular conditions. Additionally, the procedures described herein may be used to treat either dry or wet age-related macular degeneration, among other conditions.

[0069] In this example, the procedure begins by the surgeon immobilizing the tissue surrounding the patient's eye (301) (e.g., the eyelid) using an instrument such as a speculum (16) and / or any other instrument suitable for immobilization. During the immobilization described herein with respect to the tissue surrounding the eye (301), the eye (301) itself may remain free to move. Once the tissue surrounding the eye (301) is immobilized, an eye chandelier port (314) is inserted into the eye (301), as shown in FIG. 7A , to provide intraocular illumination when viewing the interior of the eye (301) through the pupil. In this example, the eye chandelier port (314) is positioned in the inferior medial quadrant so that a superior temporal sclerotomy can be performed. The eye chandelier port (314) is positioned to direct light into the interior of the eye (301) to illuminate at least a portion of the retina (308) (e.g., including at least a portion of the macula). As will be appreciated, such illumination corresponds to the area of ​​the eye (301) that is targeted for delivery of the therapeutic agent.

[0070] In this example, at the stage shown in FIG. 7A , the optical fiber 315 has not yet been inserted into the port 314; only the chandelier port 314 has been inserted. In some other versions, the optical fiber 315 may be inserted into the chandelier port 314 at this stage. In either case, a microscope may optionally be utilized to visually inspect the eye to confirm proper positioning of the eye chandelier port 314 relative to the target site. While FIG. 7A illustrates a particular positioning of the eye chandelier port 314, the eye chandelier port 314 may have any other suitable positioning, as will be apparent to those skilled in the art in view of the teachings herein.

[0071] Once the eye chandelier port (314) is in place, the sclera (304) may be accessed by dissecting the conjunctival flap and retracting the flap. After such dissection is complete, the exposed surface of the sclera (304) may optionally be blanched using a cautery instrument to minimize bleeding. Once the conjunctival abrasion is complete, the exposed surface of the sclera (304) may optionally be dried using a WECK-CEL or other suitable absorbent device.

[0072] A template may then be used to mark the eye (20), as described in U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference, and / or U.S. Pat. No. 11,000,410, issued May 11, 2021, entitled "Guide Device for Tangential Approach to the Suprachoroidal Space," the disclosure of which is incorporated herein by reference in its entirety. The surgeon may then use a visual guide created using the template to attach the suture loop assembly (332) and perform the sclerotomy using a conventional scalpel (313) or other suitable cutting instrument, as shown in FIG. 7B. By way of example only, the suture loop assembly (332) may be formed according to at least some of the teachings of U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Alternatively, in place of the suture loop assembly (332), the surgeon may place a guide tack in accordance with at least some of the teachings of US Pat. No. 11,000,410, the disclosure of which is incorporated herein by reference in its entirety.

[0073] A sclerotomy procedure involves making a small incision through the sclera (304) of the eye (301). The sclerotomy is performed with particular care to avoid penetrating the choroid (306). Thus, the sclerotomy procedure provides access to the space between the sclera (304) and the choroid (306). Once the incision has been made in the eye (301), blunt dissection may optionally be performed to locally separate the sclera (304) from the choroid (306). Such dissection may be performed using small, blunt, elongated instruments, as would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0074] Once the sclerotomy procedure is performed, the surgeon may insert the cannula (130) of the instrument (100) through the incision and into the space between the sclera (304) and the choroid (306). As can be seen in FIG. 7C , the cannula (130) is guided into the incision through a suture loop assembly (332). The suture loop assembly (332) may stabilize the cannula (130) during insertion. Additionally, the suture loop assembly (332) maintains the cannula (130) in a generally tangential orientation relative to the incision. Such a tangential orientation may reduce trauma as the cannula (130) is guided through the incision. Once the cannula (130) is inserted into the incision through the suture loop assembly (332), the surgeon may use forceps or other instruments to further guide the cannula (130) along an atraumatic path. Of course, the use of forceps or other instruments is optional and may be omitted in some instances. As previously mentioned, a guide tack (or other device) may be used in place of the suture loop assembly (332). The cannula (130) is advanced until the distal end (132) is positioned near the target area of ​​the subretinal space opposite the choroid (306). Various suitable methods for visualizing the distal end (132), and thereby observing proper positioning of the distal end (132), will be apparent to those skilled in the art in view of the teachings herein.

[0075] Although not shown, in some examples, the cannula (130) may include one or more markers on its surface to indicate various insertion depths. While merely optional, such markers may be desirable to assist the surgeon in identifying the appropriate insertion depth as the cannula (130) is guided along an atraumatic path. For example, the surgeon may visually observe the location of such markers relative to the suture loop assembly (332) and / or relative to the incision in the sclera (304) as an indication of the depth to which the cannula (130) is inserted into the eye (301). By way of example only, one such marker may correspond to approximately 6 mm of insertion depth of the cannula (130).

[0076] As shown in FIG. 7D , once the cannula (130) is at least partially inserted into the eye (301), the surgeon may insert the optical fiber (315) into the eye chandelier port (314), if the optical fiber (315) is not already inserted at this stage. With the eye chandelier port (314) in place and assembled with the optical fiber (315), the surgeon may activate the eye chandelier port (314) by directing light through the optical fiber (315) to provide illumination of the eye (301), thereby visualizing the interior of the eye (301). Further adjustments to the positioning of the cannula (130) may optionally be made at this point to ensure proper positioning relative to the region of retinal geographic atrophy (308). In some cases, the surgeon may wish to rotate the eye (301), such as by pulling the suture loop assembly (332), to orient the pupil of the eye (301) toward the surgeon to optimize visualization of the interior of the eye (301) through the pupil.

[0077] Figures 7C-7D show the cannula (130) being guided between the sclera (304) and choroid (306) to position the distal end (132) of the cannula (130) at a therapeutic agent delivery site. In this example, the delivery site corresponds to the approximately posterior region (301) of the eye, adjacent to an area of ​​retinal geographic atrophy (308). Notably, the delivery site in this example is superior to the macula, in the potential space between the neurosensory retina and the retinal pigment epithelium. By way of example only, the surgeon may rely on direct visualization via a microscope guided through the eye's pupil (301) as the cannula (130) is advanced through the range of motion shown in Figures 7C-7D, with illumination provided via the fiber (315) and port (314). The cannula (130) may be at least partially visible through the retina (308) and choroid (306) of the eye (301). Visual tracking can be enhanced in versions that use optical fibers to emit visible light through the distal end of the cannula (130).

[0078] Once the cannula (130) is advanced to the delivery site, as shown in FIG. 7D, the surgeon can advance the needle (150) of the instrument (100) as previously described by actuating the knob (120). As can be seen in FIG. 7E, the needle (150) is advanced relative to the cannula (130) so that the needle (150) penetrates the choroid (306) without penetrating the retina (308). Immediately prior to penetrating the choroid (306), the needle (150) may appear under direct visualization to "tension" the surface of the choroid (306). In other words, the needle (150) may deform the choroid (306) by pushing upward, giving it the appearance of a tent pole deforming the roof of a tent. Such a visual phenomenon can be used by the surgeon to identify whether the choroid (306) is about to be punctured and the location of the final puncture. The particular amount of needle (150) advancement sufficient to initiate "tenting" and subsequent puncture of the choroid (306) can be any suitable amount, as may be determined by many factors, including, but not limited to, general patient anatomy, local patient anatomy, operator preference, and / or other factors. As previously mentioned, an example range of needle (150) advancement can be between about 0.25 mm and about 10 mm, or, more specifically, between about 2 mm and about 6 mm.

[0079] In this example, after the surgeon confirms proper advancement of the needle 150 by visualizing the aforementioned tenting effect, they inject a balanced salt solution (BSS) or other similar solution as the needle 150 advances relative to the cannula 130. Such BSS may form a leading bleb 340 ahead of the needle 150 as it advances through the choroid 306. The leading bleb 340 may be desirable for two reasons. First, as shown in FIG. 7F, the leading bleb 340 may provide the surgeon with an additional visual indicator to indicate when the needle 150 is properly positioned at the delivery site. Second, the leading bleb 340 may provide a barrier between the needle 150 and the retina 308 once the needle 150 penetrates the choroid 306. Such a barrier may push the retinal wall outward, thereby minimizing the risk of retinal perforation as the needle (150) is advanced to the delivery site. In some versions, a foot pedal is actuated to push the leading bleb (340) from the needle (150). Alternatively, other suitable features that may be used to push the leading bleb (340) from the needle (150) will be apparent to those skilled in the art in view of the teachings herein.

[0080] Once the surgeon visualizes the leading bleb (340), the surgeon may stop the injection of BSS, leaving behind a pocket of fluid, as can be seen in FIG. 7F. A therapeutic agent (342) may then be injected by activating the fluid delivery system (80) or some other fluid delivery device, such as those described in the various references cited herein. The delivered therapeutic agent (342) may be any suitable therapeutic agent configured to treat an ocular condition. Some merely illustrative examples of suitable therapeutic agents may include, but are not necessarily limited to, drugs having smaller or larger molecules, therapeutic cell solutions, certain gene therapy solutions, tissue plasminogen activator, and / or any other suitable therapeutic agent, as will be apparent to those skilled in the art in view of the teachings herein. By way of example only, the therapeutic agent (342) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, entitled "Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells," issued August 19, 2008, the entire disclosure of which is incorporated herein by reference. In addition to, or instead of being used to deliver a therapeutic agent (342), the instrument (100) and variations thereof may be used to provide drainage and / or perform other procedures.

[0081] In this example, the amount of therapeutic agent (342) ultimately delivered to the delivery site is approximately 50 μL, although any other suitable amount may be delivered. In some versions, a foot pedal is activated to force the agent (342) out of the needle (150). Alternatively, other suitable features that may be used to force the agent (342) out of the needle (150) will be apparent to those skilled in the art in light of the teachings herein. Delivery of the therapeutic agent (342) may be visualized by the expansion of a pocket of fluid, as can be seen in FIG. 7G. As shown, the therapeutic agent (342) essentially mixes with the fluid of the leading bleb (340) as the therapeutic agent (342) is injected into the subretinal space.

[0082] Once delivery is complete, the needle (150) may be retracted by rotating the knob (120) in a direction opposite to that used to advance the needle (150), and the cannula (130) may then be withdrawn from the eye (301). Due to the size of the needle (150), the site where the needle (150) penetrates the choroid (306) is self-sealing, so that no further steps need to be taken to seal the delivery site through the choroid (306). The suture loop assembly (332) and chandelier (314) may be removed, and the incision in the sclera (304) may be closed using any suitable conventional technique.

[0083] As mentioned above, the procedures described above may be performed to treat patients with macular degeneration. In some such examples, the therapeutic agent (342) delivered by the needle (150) may include cells derived from the postpartum umbilicus and placenta. As noted above, by way of example only, the therapeutic agent (342) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, the disclosure of which is incorporated herein by reference in its entirety. Alternatively, the needle (150) may be used to deliver any other suitable substance in addition to or instead of those described in U.S. Patent No. 7,413,734 and / or elsewhere herein. By way of example only, the therapeutic agent (342) may include various types of drugs, including, but not limited to, small molecules, large molecules, cells, and / or gene therapy. It should also be understood that macular degeneration is merely an illustrative example of a condition that may be treated by the procedures described herein. Other biological conditions that may be addressed using the devices and procedures described herein will be apparent to those skilled in the art.

[0084] The above procedure may be performed using techniques described in U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety; U.S. Pat. No. 9,949,874, issued April 24, 2018, entitled "Therapeutic Agent Delivery Device with Converging Lumen," the disclosure of which is incorporated herein by reference in its entirety; U.S. Pat. No. 9,925,088, issued March 27, 2018, entitled "Subretinal Tangential Needle Catheter Guide and Introducer," the disclosure of which is incorporated herein by reference in its entirety; and U.S. Pat. No. 10,322,028, issued June 18, 2019, entitled "Method and Apparatus for Detecting Interocular Position," the disclosure of which is incorporated herein by reference in its entirety. No. 10,064,752, issued September 4, 2018, entitled "Powered Suprachoroidal Injection of Therapeutic Agents," the entire disclosure of which is incorporated herein by reference; U.S. Pat. No. 10,219,936, issued March 5, 2019, entitled "Therapeutic Agent Delivery Device with Advanceable Cannula and Needle," the entire disclosure of which is incorporated herein by reference; U.S. Pat. No. 10,258,502, issued April 16, 2019, entitled "Therapeutic Agent Delivery Device," the entire disclosure of which is incorporated herein by reference; and / or WO 2022 / 136913, published June 30, 2022, entitled "Ocular Cannula Guide," the entire disclosure of which is incorporated herein by reference.

[0085] III. Alternative Cannula Examples for Instruments

[0086] In some instances, it may be desirable to provide the cannula (130) with an atraumatic wedge-shaped distal end to aid in insertion of the cannula (130) into the space between the sclera (304) and the choroid (306), for example, through a sclerotomy. It will be appreciated that such a wedge-shaped distal end may improve the ability of the cannula (130) to effect separation between the sclera (304) and the choroid (306) by blunt dissection, thereby improving the ability of the cannula (130) to advance between such layers without trauma to the scleral or choroidal layers.

[0087] Additionally or alternatively, it may be desirable to provide the cannula (130) with a needle guide (also referred to as an insert) disposed within the needle guide lumen of the cannula (130). In this regard, one example of a needle guide is described in U.S. Pat. No. 10,478,553, the disclosure of which is incorporated herein by reference in its entirety. In some cases, it may be desirable for such a needle guide to be constructed of a material having a relatively low hardness, at least as compared to the hardness of, for example, stainless steel. It will be appreciated that such a relatively low hardness may improve the ability of the cannula (130) to conform to the particular anatomy and contours of the eye (301) by lateral bending as the cannula (130) advances toward the posterior region (301) of the eye between the sclera (304) and choroid (306) layers.

[0088] Additionally or alternatively, it may be desirable to provide the cannula 130 with varying stiffness along its length. For example, it may be desirable to provide a distal segment of the cannula 130 near its distal end with a relatively high stiffness, such as to reduce any curvature that might otherwise be imparted to the cannula 130 by the needle 150 when the needle 150 is retracted into the cannula 130 (e.g., if the needle 150 includes a preformed bend and / or curve), thereby facilitating atraumatic passage of the cannula 130 along the suprachoroidal space while the needle 150 is being retracted therein, and to provide an intermediate segment of the cannula 130 proximal to the distal segment with a relatively low stiffness, for example, to improve the ability of the cannula 130 to conform to the particular anatomy and contours of the eye 301.

[0089] 8-13 show examples of cannula (430) that can function in this manner and that can be easily incorporated into instrument (100) in place of cannula (130). Cannula (430) can be similar to cannula (130) described above, except as otherwise described below. For example, like cannula (130), cannula (430) has sufficient flexibility to conform to the particular structure and contours of a patient's eye, but cannula (430) has sufficient column strength to allow advancement of cannula (430) between the sclera and choroid of eye (301) without buckling. In some versions, cannula (430) comprises a flexible material having a hardness greater than that of the flexible material of cannula (130). For example, cannula (430) may comprise a flexible material having a hardness greater than polyether block amide (PEBA), although any other suitable material or combination of materials may be used.

[0090] The cannula (430) of this example includes a distal end (432) and a distally facing opening (434) near the distal end (432). The opening (434) of this example is adjacent to a U-shaped lateral recess (436) in the cannula (430) and provides an open distal end (438) of a needle guide lumen (439) within the cannula (430). The opening (434) is spaced proximally from the tip of the distal end (432), while the lateral recess (436) extends the length from the opening (434) to the tip of the distal end (432). In some versions, the opening (434) is oriented along a plane perpendicular to the longitudinal axis of the cannula (430). In some other versions, the opening (434) is oriented along a plane obliquely oriented relative to the longitudinal axis of the cannula (430). In either case, due to the position and configuration of opening (434) in combination with lateral recess (436), cannula (430) can be considered to provide a pathway for laterally directed exit of needle (550, 650, 750, 850, 950, 1050, 1150) from cannula (430) as needle (550, 650, 750, 850, 950, 1050, 1150) advances distally from cannula (430) as described below.

[0091] The distal end (432) is atraumatic such that the distal end (432) is configured to effect separation between the sclera (304) and choroid (306) layers via blunt dissection, thereby allowing the cannula (430) to be advanced between such layers without trauma to the sclera or choroid. In this regard, the distal end (432) of this embodiment is defined by a longitudinally extending lower surface (433) and an obliquely extending upper surface (435) that tapers distally downward toward the lower surface (433) such that the distal end (432) is generally wedge-shaped. As shown, in this embodiment, a U-shaped lateral recess (436) extends through the upper surface (435) of the distal end (432). It will be understood that the distal end (432) may be provided with a wedge shape in any other suitable manner. As described above, the wedge shape of the distal end (432) may improve the ability of the cannula (430) to effect separation between the sclera (304) and the choroid (306) via blunt dissection, thereby improving the ability of the cannula (430) to advance between the sclera (304) and choroid (306) layers without trauma to such layers. The wedge shape of the distal end (432) may also help maintain the angular orientation of the distal end (432) of the cannula (430) about the longitudinal axis of the cannula (430) as the cannula (430) advances toward the posterior region of the eye (301) between the sclera (304) and choroid (306) layers. In other words, the wedge shape of the distal end (432) helps maintain the orientation of the lateral recess (436) toward the interior region of the eye (301), thereby promoting the proper trajectory of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) toward the interior region of the eye (301) as the needle (150, 550, 650, 750, 850, 950, 1050, 1150) advances distally from the cannula (430).

[0092] In the illustrated example, cannula (430) has a cross-sectional area that varies along the length of cannula (430), and as a result, cannula (430) may have a stiffness that similarly varies along the length of cannula (430). As best shown in Figures 8 and 10-11, cannula (430) in this example includes a proximal segment (430p), an intermediate segment (430m), and a distal segment (430d). In the illustrated example, distal segment (430d) is immediately proximal to wedge-shaped distal end (432) of cannula (430) such that the upper and lower surfaces of distal segment (430d) are in direct, continuous contact with the upper and lower surfaces (433, 435) of distal end (432), respectively.

[0093] The proximal segment 430p may have a generally rectangular (e.g., oval) cross-sectional profile and a first cross-sectional area, and may be configured to be manipulated by a surgeon to push or pull the intermediate and distal segments 430m, 430d during use. While the proximal segment 430p in this example has a generally rectangular cross-sectional profile, it will be understood that any other suitable cross-sectional profile (e.g., elliptical, etc.) may be used.

[0094] As shown in FIG. 12 , the intermediate segment (430m) has a generally diamond-shaped cross-sectional profile and a second cross-sectional area that is smaller than the first cross-sectional area. In this regard, the cannula (430) may taper laterally and / or laterally inwardly from the proximal segment (430p) to the intermediate segment (430m). While the intermediate segment (430m) in this embodiment has a generally diamond-shaped cross-sectional profile, it will be understood that any other suitable cross-sectional profile (e.g., rectangular, oval, etc.) may be used. It will be understood that the reduced cross-sectional area of ​​the intermediate segment (430m) relative to the proximal segment (430p) may provide the intermediate segment (430m) with a stiffness that is lower than the stiffness of the proximal segment (430p), thereby contributing to a varying stiffness of the cannula (430) along the length of the cannula (430). As previously mentioned, the relatively low stiffness of the intermediate segment (430m) may improve the ability of the cannula (430) to conform to the particular anatomy and contours of the eye (301). In some versions, the intermediate segment (430m) has a length that is longer than the respective lengths of the proximal and distal segments (430p, 430d). For example, the intermediate segment (430m) may have a length that is longer than the combined length of the proximal and distal segments (430p, 430d) and may comprise the majority of the overall length of the cannula (430).

[0095] As shown in FIG. 13, distal segment 430d has a generally rectangular (e.g., oval) cross-sectional profile and a third cross-sectional area that is larger than the second cross-sectional area. In this regard, cannula 430 may taper laterally and / or laterally outward from intermediate segment 430m to distal segment 430d. In some versions, the third cross-sectional area may be smaller than the first cross-sectional area. While distal segment 430d in this example has a generally rectangular cross-sectional profile, it will be understood that any other suitable cross-sectional profile (e.g., elliptical, etc.) may be used.

[0096] It will be appreciated that the increased cross-sectional area of ​​distal segment 430d relative to intermediate segment 430m may provide distal segment 430d with a stiffness greater than that of intermediate segment 430m, thereby contributing to the varying stiffness of cannula 430 along its length. In some versions, distal segment 430d of cannula 430 may have a cross-sectional area substantially equal to the cross-sectional area of ​​cannula 130. For example, the width of distal segment 430d may range from about 1.28 mm to about 1.92 mm, or more specifically, about 1.6 mm, and / or the height of distal segment 430d may range from about 0.48 mm to about 0.72 mm, or more specifically, about 0.6 mm. As mentioned above, cannula 430 may also include a flexible material having a stiffness greater than that of the material of cannula 130. Thus, the distal segment (430d) of the cannula (430) may have increased stiffness relative to the stiffness of the cannula (130). For example, the distal segment (430d) may have a stiffness greater than that of the cannula (130) at or near the distal end (132) of the cannula (130). As previously mentioned, the relatively high stiffness of the distal segment (430d) may reduce any curvature that may be imparted to the cannula (430) by a needle, such as the needle (150), retracted into the cannula (430), thereby facilitating atraumatic passage of the cannula (430) along the suprachoroidal space while the needle (150) is being retracted therein.

[0097] In this embodiment, when the cannula (430) is positioned within the suprachoroidal space, the generally rectangular, oval, or otherwise generally flat cross-sectional profile of the distal segment (430d) of the cannula (430) prevents the cannula (430) from rotating about its longitudinal axis.

[0098] In other words, the cross-sectional profile of the distal segment (430d) of the cannula (430) helps maintain the orientation of the lateral recess (436) toward the interior region of the eye (301), thereby promoting the proper trajectory of the needle (550, 650, 750, 850, 950, 1050, 1150) toward the interior region of the eye (301) as the needle (550, 650, 750, 850, 950, 1050, 1150) advances distally from the cannula (430). Thus, the wedge shape of the distal end 432 in combination with the cross-sectional profile of the distal segment 430d may provide a consistent and predictable exit path for the needle 150, 550, 650, 750, 850, 950, 1050, 1150 as the needle 150, 550, 650, 750, 850, 950, 1050, 1150 advances distally relative to the cannula 430. The cross-sectional profiles of the proximal segment 430p and / or the intermediate segment 430m may provide a similar effect.

[0099] In the illustrated example, the needle guide 441 is disposed within the needle guide lumen 439 of the cannula 430. The needle guide 441 may be secured within the needle guide lumen 439 of the cannula 430 by a press or interference fit, by adhesive, by a mechanical locking mechanism, and / or by any other suitable method. In this example, the needle guide 441 is formed from a polyimide material; however, it should be understood that any other suitable biocompatible material may be used, such as any other suitable biocompatible material having a hardness less than that of stainless steel. The needle guide 441 in this example is substantially straight, but may be curved within the cannula 430. The needle guide 441 defines a needle lumen 443 configured to slidably receive a needle, such as any of the needles 150, 550, 650, 750, 850, 950, 1050, or 1150 described herein. As previously mentioned, the relatively low hardness of the needle guide (441) material may improve the ability of the cannula (430) to conform to the particular anatomy and contours of the eye (301).

[0100] IV. Examples of Alternative Needles for Devices

[0101] In some cases, it may be desirable to provide one or more preformed curves on the needle 150 so that the needle 150 can impart at least some curvature to the cannula 130 when the needle 150 is slidably disposed therein. Such curves may improve the ability of the needle 150 to access the subretinal space of relatively small eyes 301 (e.g., approximately 16 mm in diameter, or otherwise less than approximately 24 mm in diameter), at least as compared to the eyes 301 of adult patients (e.g., the eyes of pediatric human patients). Such curves on the needle 150 may improve the ability of the needle 150 and / or the cannula 130 to conform to the particular anatomy and contours of the eye 301. Additionally or alternatively, such curves may inhibit inadvertent movement of the distal tip 152 of the needle 150 that might otherwise result from movement of the body 110 of the instrument 100. It will be appreciated that by inhibiting such inadvertent movement of the distal tip (152), such a curve may help to consistently maintain the distal tip (152) along a predetermined trajectory and angle it in a predetermined orientation while within the eye (301), thereby improving the ability of the needle (150) to access the subretinal space of the eye (301).

[0102] Various illustrative examples of such needles (550, 650, 750, 850, 950, 1050, 1150) are described in more detail below. Although needles (550, 650, 750, 850, 950, 1050, 1150) are described below in connection with cannula (130), it will be understood that any of needles (550, 650, 750, 850, 950, 1050, 1150) may be used with cannula (430). For example, any of needles (550, 650, 750, 850, 950, 1050, 1150) may be readily incorporated into instrument (100) in place of needle (150), and cannula (430) may be readily incorporated into instrument (100) in place of cannula (130). Although the above examples are provided in the context of a relatively small eye (301), the following teachings may also be used in the context of an eye (301) of an adult patient, and as a result, the following teachings are not limited to the context of a relatively small eye (301).

[0103] A. First example of a needle with a proximal curve and a distal curve

[0104] 14-15 illustrate an example of a needle 550 that can be readily incorporated into the device 100 in place of the needle 150. The needle 550 may be similar to the needle 150 described above, unless otherwise noted below. In this regard, the needle 550 of this example has a sharpened distal tip 552 and defines a lumen (not shown). The distal tip 552 of this example has a single bevel configuration. In some other versions, the distal tip 552 has a tribevel configuration or any other suitable configuration, such as those described in U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Still other suitable forms that the distal tip 552 may take will be apparent to those skilled in the art in light of the teachings herein. In this example, the needle 550 is formed from nitinol, although it should be understood that any other suitable material (e.g., stainless steel, etc.) may be used.

[0105] The needle (550) of this example includes a substantially straight proximal section (560), a substantially curved proximal section (562), a substantially straight intermediate section (564), a substantially curved distal section (566), and a substantially straight distal section (568). The proximal curved section (562) is longitudinally interposed between the proximal straight section (560) and the intermediate straight section (564), the intermediate straight section (564) is longitudinally interposed between the proximal curved section (562) and the distal curved section (566), the distal curved section (566) is longitudinally interposed between the intermediate straight section (564) and the distal straight section (568), and the distal straight section (568) is longitudinally interposed between the distal curved section (566) and the distal tip (552). In the illustrated example, the proximal curved portion (562) and the distal curved portion (566) are curved in opposite directions to provide a generally S-shaped configuration for the needle (550). For example, the proximal curved portion (562) is curved distally in a generally clockwise direction within the frame of reference of Figures 14-15, and the distal curved portion (566) is curved distally in a generally counterclockwise direction.

[0106] The proximal straight section (560) may be housed within the body (110) of the instrument (100), for example, to facilitate actuation of the needle (550) via the actuation knob (120), and thus may be configured to remain outside the eye (301) during use. In some other versions, at least a portion of the proximal straight section (560) may be housed within a proximal portion of the cannula (130, 430) but may still be outside the eye (301) during use. The proximal curved section (562) may likewise be configured to remain outside the eye (301) during use, while each of the intermediate straight section (564), distal curved section (566), and distal straight section (568) may be configured to be at least partially disposed within the eye (301) during use. For example, at least the intermediate straight section 564, along with the portion of the cannula 130, 430 in which the intermediate straight section 564 is disposed, may be configured to conform to the curvature of the eye 301. Additionally or alternatively, the proximal curved section 562 may be configured to remain disposed within the cannula 130, 430 when the needle 550 is advanced distally relative to the cannula 130, 430, e.g., during initial tenting and / or subsequent puncture of the choroid 306.

[0107] It should be understood that a portion of the needle (550) may be "disposed within the eye (301) during use" even if a portion of the needle (550) is still within the cannula (130, 430), provided that a corresponding portion of the cannula (130, 430) is disposed within the eye (301). Thus, a portion of the needle (550) need not be exposed distally relative to the cannula (130, 430) for a portion of the needle (550) to be "disposed within the eye (301) during use."

[0108] The needle (550) is configured to provide a proximal curved portion (562) and a distal curved portion (566) as preformed features such that the needle (550) is resiliently biased to assume the generally S-shaped configuration shown in FIG. 14. In the illustrated example, the proximal straight portion (560) has a length (L1), the proximal curved portion (562) has a constant radius of curvature (R1), an arc length (S1), and a center of curvature (C1) located a distance (X1) from the proximal end of the needle (550) along a first (e.g., horizontal) axis and a distance (Y1) from the proximal end of the needle (550) along a second (e.g., vertical) axis, the intermediate straight portion (564) has a length (L2), the distal curved portion (566) has a constant radius of curvature (R2) and an arc length (S2), and the distal straight portion (568) has a length (L3).

[0109] By way of example only, the length (L1) may range from about 11.52 mm to about 17.28 mm, or more specifically about 14.4 mm, the radius of curvature (R1) may range from about 14.4 mm to about 21.6 mm, or more specifically about 18 mm, the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, the distance (X1) may range from about 11.52 mm to about 17.28 mm, or more specifically about 14.4 mm, and the distance (Y1) may range from about 14.36 mm to about 21.54 mm. The length (L2) may range from about 32 mm to about 48 mm, more specifically about 40 mm, the radius of curvature (R2) may range from about 2.8 mm to about 4.2 mm, more specifically about 3.5 mm, the arc length (S2) may range from about 3.36 mm to about 5.04 mm, more specifically about 4.2 mm, and / or the length (L3) may range from about 0.56 mm to about 0.84 mm, more specifically about 0.7 mm.

[0110] The proximal straight portion (560) may be configured to extend proximally, away from the eye (301), toward the body (110) of the instrument (100), while the intermediate straight portion (564), the distal curved portion (566), and / or the distal straight portion (568) are disposed within the eye (301). In this regard, the intermediate straight portion (564) and the portion of the cannula (130, 430) in which the intermediate straight portion (564) is disposed may conform to the curvature of the eye (301), while the proximal curved portion (562) may curve in the opposite direction, imparting at least some curvature to the cannula (130, 430), such that the portion of the cannula (130, 430) outside the eye (301) may likewise curve in the opposite direction. For example, in any one or more of the stages shown in Figures 7C-7G, the proximal curve (562) may curve the portion of the cannula (130, 430) outside the eye (301) approximately clockwise in the proximal direction, away from the eye (301) and toward the body (110), within the frame of reference of Figures 7C-7G.

[0111] Such induced bending of the cannula (130, 430) by the proximal curved portion (562) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (552), thereby inhibiting inadvertent movement of the distal tip (552) that might otherwise result from movement of the body (110). For example, the proximal curved portion (562) and / or the portion of the cannula (130, 430) in which the proximal curved portion (562) is disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the intermediate straight portion (564), the distal curved portion (566), and the distal straight portion (568) of the needle (550). Additionally or alternatively, the induced curvature of the cannula (130, 430) by the proximal curvature (562) may further assist the portion of the cannula (130, 430) within the eye (301) in conforming to the curvature of the eye (301).

[0112] The needle (550) in this example includes a single proximal curved portion (562) having a constant radius of curvature (R1), although in some other versions, the radius of curvature (R1) may be variable and / or multiple proximal curved portions (562) may be provided, as described in more detail below.

[0113] Distal curved portion (566) may be configured to orient distal tip (552) along one or more predetermined exit axes during distal advancement of needle (550) relative to cannula (130, 430) to protrude from opening (134). For example, distal curved portion (566) may be constructed and operative in accordance with at least a portion of U.S. Patent No. 10,478,553, the disclosure of which is incorporated herein by reference in its entirety.

[0114] B. A second example of a needle with a proximal curve and a distal curve

[0115] 16-17 illustrate another example of a needle 650 that may be readily incorporated into the device 100 in place of the needle 150. The needle 650 may be similar to the needle 550 described above, unless otherwise noted below. In this regard, the needle 650 of this example has a sharpened distal tip 652 and defines a lumen (not shown).

[0116] The needle (650) of this example includes a substantially straight proximal section (660), a substantially curved proximal section (662), a substantially straight intermediate section (664), a substantially curved distal section (666), and a substantially straight distal section (668). In the illustrated example, the proximal curved section (662) and the distal curved section (666) are curved in opposite directions to provide the needle (650) with a generally S-shaped configuration. For example, the proximal curved section (662) is curved distally in a generally clockwise direction within the frame of reference of Figures 16-17, and the distal curved section (666) is curved distally in a generally counterclockwise direction.

[0117] Needle (650) is configured to provide proximal curved portion (662) and distal curved portion (666) as preformed features such that needle (650) is resiliently biased into the generally S-shaped configuration shown in Figure 16. In the illustrated example, proximal straight portion (660) has a length (L1), proximal curved portion (662) has a constant radius of curvature (R1) and arc length (S1), intermediate straight portion (664) has a length (L2), distal curved portion (666) has a constant radius of curvature (R2) and arc length (S2), and distal straight portion (668) has a length (L3).

[0118] By way of example only, the length (L1) may range from about 11.52 mm to about 17.28 mm, or more specifically about 14.4 mm; the radius of curvature (R1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm; the arc length (S1) may range from about 24 mm to about 36 mm, or more specifically about 30 mm; the length (L2) may range from about 24 mm to about 36 mm, or more specifically about 30 mm; the radius of curvature (R2) may range from about 2.8 mm to about 4.2 mm, or more specifically about 3.5 mm; the arc length (S2) may range from about 3.36 mm to about 5.04 mm, or more specifically about 4.2 mm; and / or the length (L2) may range from about 0.56 mm to about 0.84 mm, or more specifically about 0.7 mm.

[0119] In some versions, the proximal curve (662) may curve the portion of the cannula (130, 430) outside the eye (301) away from the eye (301) and toward the body (110) in a manner similar to that described above in connection with Figure 14. Such induced curvature of the cannula (130, 430) by the proximal curve (662) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (652), thereby inhibiting inadvertent movement of the distal tip (652) that might otherwise result from movement of the body (110). For example, the proximal curved portion 662 and / or the portion of the cannula 130, 430 in which the proximal curved portion 662 is disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the intermediate straight portion 664, the distal curved portion 666, and the distal straight portion 668 of the needle 650. Additionally or alternatively, the induced curvature of the cannula 130, 430 by the proximal curved portion 662 may further assist the portion of the cannula 130, 430 within the eye 301 in conforming to the curvature of the eye 301.

[0120] C. A third example of a needle with a proximal curve and a distal curve

[0121] 18-19 illustrate another example of a needle 750 that may be readily incorporated into the device 100 in place of needle 150. Needle 750 may be similar to needle 550 described above, unless otherwise noted below. In this regard, needle 750 in this example has a sharpened distal tip 752 and defines a lumen (not shown).

[0122] The needle (750) of this example includes a substantially straight proximal section (760), a substantially curved proximal section (762), a substantially straight intermediate section (764), a substantially curved distal section (766), and a substantially straight distal section (768). In the illustrated example, the proximal curved section (762) and the distal curved section (766) are curved in opposite directions to provide the needle (750) with a generally S-shaped configuration. For example, the proximal curved section (762) is curved distally in a generally clockwise direction within the frame of reference of Figures 18-19, and the distal curved section (766) is curved distally in a generally counterclockwise direction.

[0123] Needle (750) is configured to provide proximal curved portion (762) and distal curved portion (766) as preformed features such that needle (750) is resiliently biased into the generally S-shaped configuration shown in Figure 18. In the illustrated example, proximal straight portion (760) has a length (L1), proximal curved portion (762) has a constant radius of curvature (R1) and arc length (S1), intermediate straight portion (764) has a length (L2), distal curved portion (766) has a constant radius of curvature (R2) and arc length (S2), and distal straight portion (768) has a length (L3).

[0124] By way of example only, the length (L1) may range from about 11.52 mm to about 17.28 mm, or more specifically about 14.4 mm; the radius of curvature (R1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm; the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm; the length (L2) may range from about 32 mm to about 48 mm, or more specifically about 40 mm; the radius of curvature (R2) may range from about 2.8 mm to about 4.2 mm, or more specifically about 3.5 mm; the arc length (S2) may range from about 3.36 mm to about 5.04 mm, or more specifically about 4.2 mm; and / or the length (L2) may range from about 0.56 mm to about 0.84 mm, or more specifically about 0.7 mm.

[0125] In some versions, the proximal curve (762) may curve the portion of the cannula (130, 430) outside the eye (301) away from the eye (301) and toward the body (110) in a manner similar to that described above in connection with Figure 14. Such induced curvature of the cannula (130, 430) by the proximal curve (762) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (752), thereby inhibiting inadvertent movement of the distal tip (752) that might otherwise result from movement of the body (110). For example, the proximal curved portion 762 and / or the portion of the cannula 130, 430 in which the proximal curved portion 762 is disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the intermediate straight portion 764, the distal curved portion 766, and the distal straight portion 768 of the needle 750. Additionally or alternatively, the induced curvature of the cannula 130, 430 by the proximal curved portion 762 may further assist the portion of the cannula 130, 430 within the eye 301 in conforming to the curvature of the eye 301.

[0126] D. Example of a needle with a first proximal curve and a second proximal curve and a distal curve

[0127] 20-23 illustrate another example of a needle 850 that may be readily incorporated into the device 100 in place of the needle 150. The needle 850 may be similar to the needle 550 described above, unless otherwise noted below. In this regard, the needle 850 of this example has a sharpened distal tip 852 and defines a lumen (not shown).

[0128] The needle (850) of this embodiment includes a substantially straight proximal portion (860), a first substantially curved proximal portion (862), a second substantially curved proximal portion (863), a substantially straight intermediate portion (864), a substantially curved distal portion (866), and a substantially straight distal portion (868). The first proximal curved portion (862) is longitudinally interposed between the proximal straight portion (860) and the second proximal curved portion (863), the second proximal curved portion (863) is longitudinally interposed between the first proximal curved portion (862) and the intermediate straight portion (864), the intermediate straight portion (864) is longitudinally interposed between the second proximal curved portion (863) and the distal curved portion (866), the distal curved portion (866) is longitudinally interposed between the intermediate straight portion (864) and the distal straight portion (868), and the distal straight portion (868) is longitudinally interposed between the distal curved portion (866) and the distal tip (852). In the illustrated example, the proximal curved portions (862, 863) and the distal curved portion (866) are curved in opposite directions to provide a generally S-shaped configuration for the needle (850). For example, each of the proximal curved portions (862, 863) is curved distally in a generally clockwise direction within the frame of reference of Figures 20-23, and the distal curved portion (866) is curved distally in a generally counterclockwise direction.

[0129] The needle (850) is configured to provide proximal curved portions (862, 863) and distal curved portions (866) as preformed features such that the needle (850) is resiliently biased to assume the generally S-shaped configuration shown in Figures 20 and 22-23. In the illustrated example, the proximal straight portion (860) has a length (L1), the first proximal curved portion (862) has a constant radius of curvature (R1), an arc length (S1), and a center of curvature (C1) defined by a reference circle having a center (C1) and a first diameter (D1) located along a first (e.g., horizontal) axis a distance (X1) from the proximal end of the needle (850) and a second (e.g., vertical) axis a distance (Y1) from the proximal end of the needle (850), and the second proximal curved portion (863) has a constant radius of curvature (R2) and an arc length (S2), and a center of curvature (C2) defined by a reference circle having a center (C2) and a second diameter (D2) located along a first (e.g., horizontal) axis a distance (X2) from the proximal end of the needle (850) and a second (e.g., vertical) axis a distance (Y2) from the proximal end of the needle (850), the intermediate straight portion (864) having a length (L2), the distal curved portion (866) having a constant radius of curvature (R3) and an arc length (S3), and the distal straight portion (868) having a length (L3).

[0130] By way of example only, the length (L1) may range from about 11.52 mm to about 17.28 mm, or more specifically about 14.4 mm, the radius of curvature (R1) may range from about 14.4 mm to about 21.6 mm, or more specifically about 18 mm, the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, and the distance (X1) may range from about 11.52 mm to about 17.28 mm. The distance (Y1) may be in the range of about 14.4 mm to about 21.6 mm, more specifically about 18 mm, the diameter (D1) may be in the range of about 28.8 mm to about 43.2 mm, more specifically about 36 mm, the radius of curvature (R2) may be in the range of about 10 mm to about 15 mm, more specifically about 12.5 mm, and the arc length (S2) may be in the range of about 16 mm to about 24 mm. The distance (X2) may be in the range of about 15.46 mm to about 23.2 mm, more specifically about 19.33 mm, the distance (Y1) may be in the range of about 12.45 mm to about 18.67 mm, more specifically about 15.56 mm, the diameter (D2) may be in the range of about 20 mm to about 30 mm, more specifically about 25 mm, and the length (L2) may be about 16 mm. The radius of curvature (R3) may be in the range of about 2.8 mm to about 4.2 mm, more specifically about 3.5 mm, the arc length (S3) may be in the range of about 3.36 mm to about 5.04 mm, more specifically about 4.2 mm, and / or the length (L3) may be in the range of about 0.56 mm to about 0.84 mm, more specifically about 0.7 mm.

[0131] In some versions, one or both proximal curves (862, 863) may cause the portion of the cannula (130, 430) outside the eye (301) to curve away from the eye (301) and toward the body (110), in a manner similar to that described above in connection with Figure 14. Such induced curvature of the cannula (130, 430) by one or both proximal curves (862, 863) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (852), thereby inhibiting inadvertent movement of the distal tip (852) that might otherwise result from movement of the body (110). For example, one or both proximal curved portions 862, 863 and / or the portion of the cannula 130, 430 in which one or both proximal curved portions 862, 863 are disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the intermediate straight portion 864, the distal curved portion 866, and the distal straight portion 868 of the needle 850. Additionally or alternatively, the induced curvature of the cannula 130, 430 by one or both proximal curved portions 862, 863 may further assist the portion of the cannula 130, 430 within the eye 301 in conforming to the curvature of the eye 301.

[0132] E. Example of a needle with first and second distal curves

[0133] 24-26 illustrate another example of a needle 950 that can be readily incorporated into the device 100 in place of the needle 150. The needle 950 may be similar to the needle 150 described above, unless otherwise noted below. In this regard, the needle 950 of this example has a sharpened distal tip 952 and defines a lumen (not shown). The distal tip 952 of this example has a single bevel configuration. In some other versions, the distal tip 952 has a tribevel configuration or any other suitable configuration, such as those described in U.S. Pat. No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Still other suitable forms that the distal tip 952 may take will be apparent to those skilled in the art in light of the teachings herein. In this example, the needle 950 is formed from nitinol, although it should be understood that any other suitable material (e.g., stainless steel, etc.) may be used.

[0134] The needle (950) of this example includes a substantially straight proximal portion (960), a first substantially curved distal portion (965), a second substantially curved distal portion (966), and a substantially straight distal portion (968). The first distal curved portion (965) is longitudinally interposed between the proximal straight portion (960) and the second distal curved portion (966), the second distal curved portion (966) is longitudinally interposed between the first distal curved portion (965) and the distal straight portion (968), and the distal straight portion (968) is longitudinally interposed between the second distal curved portion (966) and the distal tip (952). In the illustrated example, the distal curved portions (965, 966) are curved in the same direction as each other, providing the needle (950) with a generally J-shaped configuration. For example, each of the distal curved portions (965, 966) curves generally counterclockwise in the distal direction within the frame of reference of Figures 24-26.

[0135] Each of the proximal straight portion (960), the distal curved portions (965, 966), and the distal straight portion (968) may be configured to reside at least partially within the eye (301) during use. For example, at least the proximal straight portion (960), together with the portion of the cannula (130, 430) in which the proximal straight portion (960) is disposed, may be configured to conform to the curvature of the eye (301). Additionally or alternatively, the first distal curved portion (965) may have a radius of curvature substantially equal to the radius of curvature of the eye (301).

[0136] Needle (950) is configured to provide distal curves (965, 966) as preformed features such that needle (950) is resiliently biased into the generally J-shaped configuration shown in Figures 24 and 26. In the illustrated example, the proximal straight portion (960) has a length (L1), the first distal curved portion (965) has a constant radius of curvature (R1), an arc length (S1), and a center of curvature (C1) defined by a reference circle having a center (C1) and a diameter (D1) located along a first (e.g., horizontal) axis a distance (X1) from the proximal end of the needle (950) and a distance (Y1) from the proximal end of the needle (950) along a second (e.g., vertical) axis, the second distal curved portion (966) has a constant radius of curvature (R2) and an arc length (S2), and the distal straight portion (968) has a length (L2).

[0137] By way of example only, the length (L1) may range from about 43.52 mm to about 65.28 mm, or more specifically about 54.4 mm, the radius of curvature (R1) may range from about 10 mm to about 15 mm, or more specifically about 12.5 mm, the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, the distance (X1) may range from about 43.52 mm to about 65.28 mm, or more specifically about 54.4 mm, and the distance (Y1) may range from about 9.94 mm to about 14.9 mm. The radius of curvature (R2) may range from about 2.8 mm to about 4.2 mm, more specifically about 3.5 mm, the arc length (S2) may range from about 3.36 mm to about 5.04 mm, more specifically about 4.2 mm, and / or the length (L2) may range from about 0.56 mm to about 0.84 mm, more specifically about 0.7 mm.

[0138] In some versions, the first distal curved portion (965) can impart at least some curvature to the cannula (130, 430), such as during any one or more of the steps shown in Figures 7C-7G. Such induced curvature of the cannula (130, 430) by the first distal curved portion (965) can limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (952), thereby inhibiting inadvertent movement of the distal tip (952) that might otherwise result from movement of the body (110). For example, the first distal curved portion (965) and / or the portion of the cannula (130, 430) in which the first distal curved portion (965) is disposed can effectively absorb some or all of such movement instead of transmitting such movement distally to the second distal curved portion (966) and distal straight portion (968) of the needle (950). Additionally or alternatively, the induced curvature of the cannula (130, 430) by the first distal curvature (965) may further assist the portion of the cannula (130, 430) within the eye (301) in conforming to the curvature of the eye (301).

[0139] The second distal curved portion (966) may be configured to orient the distal tip (952) along one or more predetermined exit axes during distal advancement of the needle (950) relative to the cannula (130, 430) to protrude from the opening (134). For example, the distal curved portion (966) may be constructed and operative in accordance with at least a portion of U.S. Patent No. 10,478,553, the disclosure of which is incorporated herein by reference in its entirety.

[0140] F. Example of a needle with a proximal curve and first and second distal curves

[0141] 27-28 illustrate another example of needle 1050 that may be readily incorporated into device 100 in place of needle 150. Needle 1050 may be similar to needle 550 and / or needle 950 described above, unless otherwise noted below. In this regard, needle 1050 in this example has a sharpened distal tip 1052 and defines a lumen (not shown).

[0142] The needle (1050) of this embodiment includes a substantially straight proximal portion (1060), a substantially curved proximal portion (1062), a substantially straight intermediate portion (1064), a first substantially curved distal portion (1065), a second substantially curved distal portion (1066), and a substantially straight distal portion (1068). The proximal curved portion (1062) is longitudinally interposed between the proximal straight portion (1060) and the intermediate straight portion (1064), the intermediate straight portion (1064) is longitudinally interposed between the proximal curved portion (1062) and the first distal curved portion (1065), the first distal curved portion (1065) is longitudinally interposed between the intermediate straight portion (1064) and the second distal curved portion (1066), the second distal curved portion (1066) is longitudinally interposed between the first distal curved portion (1065) and the distal straight portion (1068), and the distal straight portion (1068) is longitudinally interposed between the second distal curved portion (1066) and the distal tip (1052). In the illustrated example, the proximal curved portion (1062) and the distal curved portions (1065, 1066) are curved in opposite directions to provide a generally S-shaped configuration for the needle (1050). For example, the proximal curved portion (1062) is curved distally in a generally clockwise direction within the frame of reference of Figures 27-28, and the distal curved portions (1065, 1066) are each curved distally in a generally counterclockwise direction.

[0143] The needle (1050) is configured to provide the proximal curved portion (1062) and the distal curved portions (1065, 1066) as preformed features such that the needle (1050) is resiliently biased to assume the generally S-shaped configuration shown in Figure 27. In the illustrated example, the proximal straight portion (1060) has a length (L1), the proximal curved portion (1062) has a constant radius of curvature (R1) and an arc length (S1), the intermediate straight portion (1064) has a length (L2), the first distal curved portion (1065) has a constant radius of curvature (R2) and an arc length (S2), the second distal curved portion (1066) has a constant radius of curvature (R3) and an arc length (S3), and the distal straight portion (1068) has a length (L3).

[0144] By way of example only, the length (L1) may range from about 19.92 mm to about 29.88 mm, or more specifically about 24.9 mm, the radius of curvature (R1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, the length (L2) may range from about 16 mm to about 24 mm, or more specifically about 20 mm, and the radius of curvature (R2) may range from about 13.6 mm to about 20.4 mm. and / or the length (L3) may be in the range of about 0.56 mm to about 0.84 mm, more specifically about 0.7 mm.

[0145] In some versions, the intermediate straight section (1064) may be omitted so that the proximal curved section (1062) can directly join with the first distal curved section (1065). Additionally or alternatively, the proximal straight section (1060) may have a slight curvature such that the proximal straight section (1060) may have an arc length (S0). In some versions, the arc lengths (S0, S1, S2, S3) of the proximal straight section (1060), the proximal curved section (1062), the first distal curved section (1065), and the second distal curved section (1066) may be selected from the table below, with all values ​​being approximate. [Table 1]

[0146] In some versions, the proximal curve (1062) may curve the portion of the cannula (130, 430) outside the eye (301) away from the eye (301) and toward the body (110) in a manner similar to that described above in connection with Figure 14. Such induced curvature of the cannula (130, 430) by the proximal curve (1062) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (1052), thereby inhibiting inadvertent movement of the distal tip (1052) that might otherwise result from movement of the body (110). For example, the proximal curved portion 1062 and / or the portion of the cannula 130, 430 in which the proximal curved portion 1062 is disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the intermediate straight portion 1064, the first distal curved portion 1065, the second distal curved portion 1066, and the distal straight portion 1068 of the needle 1050. Additionally or alternatively, the induced curvature of the cannula 130, 430 by the proximal curved portion 1062 may further assist the portion of the cannula 130, 430 within the eye 301 in conforming to the curvature of the eye 301.

[0147] G. Example of a needle having first and second proximal curves and first and second distal curves

[0148] 29-30 illustrate another example of needle 1150 that may be readily incorporated into device 100 in place of needle 150. Needle 1150 may be similar to needle 550 and / or needle 950 described above, unless otherwise noted below. In this regard, needle 1150 in this example has a sharpened distal tip 1152 and defines a lumen (not shown).

[0149] The needle (1150) of this embodiment includes a substantially straight proximal portion (1160), a first substantially curved proximal portion (1162), a second substantially curved proximal portion (1163), a first substantially curved distal portion (1165), a second substantially curved distal portion (1166), and a substantially straight distal portion (1168). The first proximal curved portion (1162) is longitudinally interposed between the proximal straight portion (1160) and the second proximal curved portion (1163), the second proximal curved portion (1163) is longitudinally interposed between the first proximal curved portion (1162) and the first distal curved portion (1165), the first distal curved portion (1165) is longitudinally interposed between the second proximal curved portion (1163) and the second distal curved portion (1166), the second distal curved portion (1166) is longitudinally interposed between the first distal curved portion (1165) and the distal straight portion (1168), and the distal straight portion (1168) is longitudinally interposed between the second distal curved portion (1166) and the distal tip (1152). In some versions, the needle (1150) can include, for example, a substantially straight intermediate portion (not shown) longitudinally interposed between the second proximal curved portion (1163) and the first distal curved portion (1165). In the illustrated example, the proximal curved portions (1162, 1163) and the distal curved portions (1165, 1166) are curved in opposite directions to provide the needle (1150) with a generally S-shaped configuration. For example, each of the proximal curved portions (1162, 1163) is curved distally in a generally clockwise direction within the frame of reference of FIGS. 29-30, and each of the distal curved portions (1165, 1166) is curved distally in a generally counterclockwise direction.

[0150] The needle (1150) is configured to provide proximal curved portions (1162, 1163) and distal curved portions (1165, 1166) as preformed features such that the needle (1150) is resiliently biased to assume the generally S-shaped configuration shown in FIG. 29. In the illustrated example, the proximal straight portion (1160) has a length (L1), the first proximal curved portion (1162) has a constant radius of curvature (R1) and an arc length (S1), the second proximal curved portion (1163) has a constant radius of curvature (R2) and an arc length (S2), the first distal curved portion (1165) has a constant radius of curvature (R3) and an arc length (S3), the second distal curved portion (1166) has a constant radius of curvature (R4) and an arc length (S4), and the distal straight portion (1168) has a length (L2).

[0151] By way of example only, the length (L1) may range from about 12.08 mm to about 18.12 mm, or more specifically about 15.1 mm; the radius of curvature (R1) may range from about 14.4 mm to about 21.6 mm, or more specifically about 18 mm; the arc length (S1) may range from about 16 mm to about 24 mm, or more specifically about 20 mm; the radius of curvature (R2) may range from about 10 mm to about 15 mm, or more specifically about 12.5 mm; and the arc length (S2) may range from about 16 mm to about 24 mm, or more specifically about 20 mm. For example, the radius of curvature (R3) may be in the range of about 10 mm to about 15 mm, more specifically about 12.5 mm, the arc length (S3) may be in the range of about 16 mm to about 24 mm, more specifically about 20 mm, the radius of curvature (R4) may be in the range of about 2.8 mm to about 4.2 mm, more specifically about 3.5 mm, the arc length (S4) may be in the range of about 3.36 mm to about 5.04 mm, more specifically about 4.2 mm, and / or the length (L2) may be in the range of about 0.56 mm to about 0.84 mm, more specifically about 0.7 mm.

[0152] In some versions, one or both proximal curves (1162, 1163) may cause the portion of the cannula (130, 430) outside the eye (301) to curve away from the eye (301) and toward the body (110), in a manner similar to that described above in connection with Figure 14. Such induced curvature of the cannula (130, 430) by one or both proximal curves (1162, 1163) may limit the effect of any movement of the body (110) of the instrument (100) on the position of the distal tip (1152), thereby inhibiting inadvertent movement of the distal tip (1152) that might otherwise result from movement of the body (110). For example, one or both proximal curved portions 1162, 1163 and / or the portion of the cannula 130, 430 in which one or both proximal curved portions 1162, 1163 are disposed may effectively absorb some or all of such movement instead of transmitting such movement distally to the first distal curved portion 1165, the second distal curved portion 1166, and the distal straight portion 1168 of the needle 1150. Additionally or alternatively, the induced curvature of the cannula 130, 430 by one or both proximal curved portions 1162, 1163 may further assist the portion of the cannula 130, 430 within the eye 301 in conforming to the curvature of the eye 301.

[0153] V. Example of a Dosing Dock for a Syringe

[0154] As mentioned above, the bleb fluid source 82 and / or the therapeutic agent fluid source 84 of the fluid delivery system 80 may include a syringe. In some cases, it may be desirable to provide for priming of the conduit assembly 140 and the device 100 to purge any air from the fluid path between the barrel of such a syringe and the distal end of the needle 150, 550, 650, 750, 850, 950, 1050, 1150, such as before inserting the cannula 130, 430 into the patient's eye 301. In this regard, those skilled in the art will recognize that insufficient priming of the conduit assembly (140) and instrument (100) may result in some residual air remaining in the fluid pathway between the syringe barrel and the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150), which may be inadvertently delivered to the subretinal space (301) of the eye, and that over-priming of the conduit assembly (140) and instrument (100) may result in some of the bleb fluid or therapeutic agent fluid that is ultimately delivered to the subretinal space (301) of the eye being inadvertently expelled from the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1050, 1150), which may result in less than the desired amount of bleb fluid or therapeutic agent fluid ultimately delivered to the subretinal space (301) of the eye. Those skilled in the art will recognize that it can be important to ensure that an appropriate amount of fluid is delivered to the subretinal space of the eye (301), particularly considering the anatomical constraints of the subretinal space. In the case of a leading bleb (340), delivering too little fluid can result in insufficient separation between the retina (308) and the choroid (306), potentially resulting in ineffectiveness of the subsequently delivered therapeutic agent (342). Similarly, delivering too little therapeutic agent (342) may fail to produce the desired therapeutic effect.

[0155] While many surgeons and their assistants may have substantial skill in ensuring that the conduit assembly (140) and instrument (100) are properly primed before using a syringe to deliver fluids, it may be desirable to provide a device that reliably and consistently ensures that the conduit assembly (140) and instrument (100) are properly primed before using a syringe to deliver fluids, so that patients do not have to rely so much on the personal skill of a surgeon or other professional to properly prime the conduit assembly (140) and instrument (100). The following describes an example of a docking dock (1200) that may be used with conventional syringes, such as those including the bleb fluid source (82) and / or therapeutic agent fluid source (84) of a fluid delivery system (80), to consistently provide precision and accuracy in the amount of air purged from the fluid path between the barrel of the syringe and the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150). This may provide consistent accuracy and precision in the amount of fluid delivered to the subretinal space as part of the procedure described above with reference to Figures 6-7G. While the administration dock (1200) is described below for use with the device (100), it will be understood that the administration dock (1200) may be used with any other suitable type of device, such as any other suitable device for subretinal and / or suprachoroidal delivery of therapeutic agents, and / or any device in which accurate and repeatable fluid delivery is desired. For example, the administration dock (1200) may be used with a suprachoroidal delivery device configured and operable in accordance with at least part of the teachings of International Publication No. WO 2022 / 172086, published August 18, 2022, entitled "Suprachoroidal Injection Device," the disclosure of which is incorporated herein by reference in its entirety.

[0156] As shown in Figures 31-34, the dispensing dock 1200 of this embodiment extends along a longitudinal axis LA between a proximal end 1202 and a distal end 1204 (Figures 32-34) and includes a proximal body portion 1210, an intermediate handle portion 1212, and a distal support portion 1214. More specifically, the body portion 1210 extends distally from the proximal end 1202 to the handle portion 1212, and extends distally from the body portion 1210 to the support portion 1214, which extends distally from the handle portion 1212 to the distal end 1204. In the illustrated example, the body portion (1210), the handle portion (1212), and the support portion (1214) are integrally formed with one another as a unitary (e.g., monolithic) piece to define the dock (1200). In this regard, the dock (1200) may be manufactured via 3D printing, injection molding, investment casting, machining, and / or any other suitable manufacturing technique. It will be understood that the dock (1200) may be constructed of any suitable material, such as a polymeric material (e.g., plastic) or a metallic material. In some variations, the dock (1200) may be constructed of a thermoplastic resin, such as polycarbonate.

[0157] The body portion (1210) of this example includes a top surface (1220), a bottom surface (1222), and a pair of side surfaces (1224). In the example shown, a generally U-shaped proximal recess (1230) extends distally from the proximal end (1202) along the longitudinal axis (LA) and downwardly from the top surface (1220), and a generally U-shaped proximal channel (1232) extends distally from the proximal recess (1230) along the longitudinal axis (LA) and downwardly from the top surface (1220). The proximal channel (1232) is sized and configured to slidably receive a portion of a syringe plunger rod (e.g., a distal portion (1332) of the plunger rod (1320)), as described in more detail below. 34, proximal recess (1230) and proximal channel (1232) may be similarly shaped, with proximal recess (1230) being wider laterally relative to top surface (1220) and / or deeper than proximal channel (1232). In this manner, proximal recess (1230) defines a generally U-shaped, proximally-facing stop surface (1234) configured to selectively engage (e.g., abut) a shoulder of the syringe plunger (e.g., shoulder (1334) of plunger (1304)) to prevent distal advancement of the syringe plunger, as described in more detail below.

[0158] In the example shown, a pair of distal recesses (1240) extend proximally from the distal end of body portion (1210) downward from top surface (1220) to respective lower shelves (1242) on opposite sides of longitudinal axis (LA), and a generally U-shaped intermediate recess (1244) extends proximally along longitudinal axis (LA) from distal recesses (1240) to proximal channel (1232). Distal recesses (1240) are sized and configured to receive respective syringe finger flanges (e.g., finger flange (1316)), as described in more detail below. As shown, a pair of tabs (1246) extend distally from respective proximal ends of distal recesses (1240) on opposite sides of the longitudinal axis (LA) and can be configured to engage with respective syringe finger flanges to help limit longitudinal movement of the syringe finger flanges relative to dock (1200). Intermediate recess (1244) is sized and configured to receive a portion of a syringe barrel (e.g., proximal cylindrical portion (1310) of syringe barrel (1302)), as described in more detail below.

[0159] The handle portion 1212 of this example includes a pair of finger flanges 1250 extending outward laterally relative to a side surface 1224 of the body portion 1210 that is opposite the longitudinal axis LA. The finger flanges 1250 may be configured to extend outward in the same direction as corresponding finger flanges of a syringe barrel coupled to the dock 1200 (e.g., finger flanges 1316 of syringe barrel 1302), such that the finger flanges 1250 may be configured to be grasped by a surgeon in a manner similar to how a surgeon might otherwise directly grasp a syringe finger flange.

[0160] In the example shown, the handle portion (1212) also includes a pair of deflectable beams (1252) extending upward on opposite sides of the longitudinal axis (LA) that are configured to cooperate with one another to firmly grip a portion of the syringe barrel (e.g., the intermediate cylindrical portion (1312) of the syringe barrel (1302)), as described in more detail below. In this regard, a pair of detents (1254) may extend laterally inward from the upper ends of each of the deflectable beams (1252) and be configured to frictionally engage the top and / or sides of the syringe barrel to inhibit movement of the syringe barrel in an upward direction relative to the dock (1200). In some variations, the deflectable beams (1252) may be resiliently biased toward an undeflected state or configured to bend into one or more deflected states. Additionally, or alternatively, the deflectable beams (1252) may be configured to provide a snap-fit ​​engagement with the syringe barrel. For example, deflectable beams 1252 may be configured to bend laterally outwardly away from one another in response to a threshold downward force applied to the syringe barrel when the syringe barrel is over detents 1254, allowing the syringe barrel to be inserted between and / or under detents 1254, and then resiliently return to their respective undeflected states and frictionally engage the top and / or sides of the syringe barrel. Deflectable beams 1252 may also be configured to bend laterally outwardly away from one another in response to a threshold upward force applied to the syringe barrel when the syringe barrel is between and / or under detents 1254 to allow removal of the syringe barrel from dock 1200.As shown, a pair of tabs (1256) extend proximally from each upper end of the deflectable beam (1252) and may be configured to engage with corresponding finger flanges of a syringe barrel coupled to the docking dock (1200) (e.g., finger flanges (1316) of syringe barrel (1302)) to help limit longitudinal movement of the syringe finger flanges relative to the docking dock (1200), such as by capturing the respective syringe finger flanges against the respective tabs (1246) of the body portion (1210) and / or the respective protrusions (1242) of the body portion (1210). In some variations, ledge (1242), tab (1246), and / or tab (1256) may be configured to cooperate with one another to facilitate positioning a portion of the syringe barrel (e.g., stop surface (1318) of syringe barrel (1302)) in a predetermined position relative to stop surface (1234).

[0161] The support portion 1214 of this example includes an elongated arm 1260 extending distally from a lower region of the stem portion 1212 below the deflectable beam 1252 and a cradle 1262 extending generally upward from the distal end of the arm 1260 such that the support portion 1214 is generally L-shaped. In the example shown, a generally U-shaped distal channel 1264 extends downwardly from an upper surface 1266 of the cradle 1262 and extends longitudinally along the longitudinal axis LA such that the distal channel 1264 is longitudinally aligned with the proximal channel 1232. The distal channel 1264 is sized and configured to receive a portion of a syringe barrel (e.g., the intermediate cylindrical portion 1312 of the syringe barrel 1302), as described in more detail below.

[0162] In the example shown, support portion (1214) also includes a pair of distally extending deflectable flanges (1270) on opposite sides of longitudinal axis (LA) that are configured to cooperate with one another to securely grip a portion of the syringe barrel (e.g., distal cylindrical portion (1314) of syringe barrel (1302)), as described in more detail below. In this regard, a pair of detents (1272) may extend laterally inward from the upper end of each of deflectable flanges (1270) and be configured to frictionally engage the top and / or side surfaces of the syringe barrel to inhibit movement of the syringe barrel in an upward direction relative to dock (1200). In some variations, deflectable flanges (1270) may be resiliently biased toward an undeflected state or configured to flex into one or more deflected states. Additionally, or alternatively, deflectable flanges (1270) may be configured to provide a snap-fit ​​engagement with the syringe barrel. For example, deflectable flanges 1270 may be configured to flex laterally outwardly away from one another in response to a threshold downward force applied to the syringe barrel when the syringe barrel is over detents 1272, allowing the syringe barrel to be inserted between and / or under detents 1272, and then resiliently return to their respective undeflected states and frictionally engage the top and / or sides of the syringe barrel. Deflectable flanges 1270 may also be configured to flex laterally outwardly away from one another in response to a threshold upward force applied to the syringe barrel when the syringe barrel is between and / or under detents 1272 to allow the syringe barrel to be removed from dock 1200.

[0163] 35A-35G show an example of a docking dock (1200) for use with an example syringe (1300). The syringe (1300) in this example includes a barrel (1302) and a plunger (1304). The barrel (1302) includes a proximal cylindrical portion (1310), an intermediate cylindrical portion (1312), and a distal cylindrical portion (1314). The barrel (1302) also includes a pair of finger flanges (1316) extending outwardly transversely relative to the proximal cylindrical portion (1310). In the example shown, the proximal cylindrical portion (1310) defines a generally annular, proximally-facing stop surface (1318) configured to selectively engage (e.g., abut) a portion of the plunger (1304) to stop distal advancement of the plunger (1304), as described in more detail below. In this regard, plunger (1304) includes an elongated rod (1320), a thumb flange (1322) at the proximal end of rod (1320), and a piston (1324) at the distal end of rod (1320). Piston (1324) is sealingly disposed within barrel (1302) such that the longitudinal position of piston (1324) within barrel (1302) may be varied to selectively vary the effective interior volume of barrel (1302), which in turn affects the volume of fluid contained within barrel (1302). In the example shown, rod (1320) includes a relatively wide proximal portion (1330) and a relatively narrow distal portion (1332) and defines a generally annular, distally-facing shoulder (1334) configured to selectively engage (e.g., abut) stop surface (1318) of barrel (1302) and stop surface (1234) of dosing dock (1200). In some versions, syringe (1300) comprises a 0.2 mL zero-residue syringe by SJJ Soltions of Zuid Holland, The Netherlands. In one aspect, the syringe (1300) is as described in U.S. Design Patent D961,067 S1, issued August 16, 2022, entitled "Syringe," or International Publication No. 2020 / 013692, published January 16, 2020, entitled "Needle Hub and Syringe Arrangement," each of which is incorporated by reference in its entirety.It will be appreciated that syringe (1300) may include any other suitable type of syringe from any other suitable source.

[0164] As shown in FIG. 35A , the barrel (1302) is initially coupled to the fluid source (1400) via the conduit (1402). In some examples, the fluid source (1400) contains a leading bleb (340) fluid. In some other examples, the fluid source (1400) contains a therapeutic agent (342) fluid. When the barrel (1302) is initially coupled to the fluid source (1400), the plunger (1304) is in a distal position relative to the barrel (1302). Also, when the barrel (1302) is initially coupled to the fluid source (1400), the syringe (1300) is completely detached from the dispensing dock (1200), in this example.

[0165] With the barrel 1302 fully coupled to the fluid source 1400, the operator retracts the plunger 1304 proximally relative to the barrel 1302 to the position shown in FIG. 35B. During such proximal retraction of the plunger 1304, the syringe 1300 draws a volume of fluid from the fluid source 1400 into the barrel 1302. This volume may be greater than the volume of fluid ultimately delivered to the subretinal space 301 of the eye.

[0166] Once a quantity of fluid has been drawn from the fluid source (1400) into the barrel (1302), the syringe (1300) is decoupled from the fluid source (1400) and coupled to the dosing dock (1200). In particular, as shown in FIG. 35C, the distal portion (1332) of the rod (1320) is inserted into the proximal channel (1232) of the dosing dock (1200), the proximal cylindrical portion (1310) of the barrel (1302) is inserted into the intermediate recess (1244) of the dosing dock (1200), and the finger flanges (1316) of the barrel (1302) are inserted into the respective distal recesses (1316) of the dosing dock (1200). 1240), an intermediate cylindrical portion (1312) of the barrel (1302) is inserted into a distal channel (1264) of the dosing dock (1200) and is firmly gripped by a deflectable beam (1252) of the dosing dock (1200), and a distal cylindrical portion (1314) of the barrel (1302) is firmly gripped by a deflectable flange (1270) of the dosing dock (1200). In this manner, the recesses (1240, 1244), the distal channel (1264), the deflectable beam (1252), and the deflectable flange (1270) may collectively define a receptacle configured to firmly receive the barrel (1302). In some variations, any one or more of recesses 1240, 1244, distal channel 1264, deflectable beam 1252, and / or deflectable flange 1270 are configured to provide a snap fit with a corresponding portion(s) of barrel 1302, thereby assisting in securing barrel 1302 to dispensing dock 1200. Additionally or alternatively, any one or more of recesses 1240, 1244, distal channel 1264, flexible beam 1252, and / or flexible flange 1270 may include one or more elastomeric and / or other features configured to grip or otherwise retain a corresponding portion(s) of barrel 1302. In this example, at the stage shown in FIG. 35C, plunger 1304 is still in a proximal position relative to barrel 1302.

[0167] As shown in Figure 35D, barrel 1302 is then coupled to instrument 100 via conduit assembly 140, both of which are described above. It will be appreciated that instrument 100 may include any suitable cannula, such as any of cannulas 130, 430 described above, and / or any suitable needle, such as any of needles 150, 550, 650, 750, 850, 950, 1050, 1150 described above.

[0168] After reaching the state shown in FIG. 35D, the operator may advance the plunger 1304 distally relative to the barrel 1302 until reaching the stage shown in FIG. 35E. At this stage, the shoulder 1334 of the plunger 1304 abuts the stop surface 1234 of the docking dock 1200. During the transition from the state shown in FIG. 35D to the state shown in FIG. 35E, the plunger 1304 drives a portion of the fluid from the barrel 1302. This, in turn, provides priming of the conduit assembly 140 and the device 100 and can purge any air from the fluid path between the barrel 1302 and the distal end of the needle 150, 550, 650, 750, 850, 950, 1050, 1150. Thus, during the transition from the state shown in Figure 35D to the state shown in Figure 35E, the cannula (130, 430) may not yet be inserted into the patient's eye (301). Fluid expelled from the distal end (150, 550, 650, 750, 850, 950, 1050, 1150) of the needle during the transition from the state shown in Figure 35D to the state shown in Figure 35E may be directed to an appropriate waste receptacle.

[0169] In some variations, the volume of fluid expelled from the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be generally equal to the difference between the volume of fluid drawn by the syringe (1300) from the fluid source (1400) into the barrel (1302) during the transition from the state shown in FIG. 35A to the state shown in FIG. 35B and the predetermined volume ultimately desired to be delivered to the subretinal space (301) of the eye. For example, the volume of fluid expelled from the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be approximately 250 microliters if the predetermined volume ultimately desired to be delivered to the subretinal space (301) of the eye is approximately 100 microliters, but approximately 350 microliters of fluid is drawn by the syringe (1300) from the fluid source (1400) to the barrel (1302) during the transition from the state shown in FIG. 35A to the state shown in FIG. 35B. As another example, the volume of fluid expelled from the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be approximately 100 microliters if the predetermined volume ultimately desired to be delivered to the subretinal space (301) of the eye is approximately 100 microliters, but approximately 200 microliters of fluid is drawn by the syringe (1300) from the fluid source (1400) to the barrel (1302) during the transition from the state shown in FIG. 35A to the state shown in FIG. 35B. As yet another example, the volume of fluid expelled from the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be approximately 15 microliters if the predetermined volume ultimately desired to be delivered to the subretinal space (301) of the eye is approximately 100 microliters, but approximately 115 microliters of fluid is drawn by the syringe (1300) from the fluid source (1400) to the barrel (1302) during the transition from the state shown in FIG. 35A to the state shown in FIG. 35B.

[0170] Additionally or alternatively, the volume of fluid expelled from the distal end (150, 550, 650, 750, 850, 950, 1050, 1150) of the needle during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be greater than or generally equal to the dead volume of the fluid path between the barrel (1302) and the distal end (150, 550, 650, 750, 850, 950, 1050, 1150) of the needle. For example, the volume of fluid expelled from the distal end (150, 550, 650, 750, 850, 950, 1050, 1150) during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may be at least about 80 microliters if the dead volume is about 80 microliters.

[0171] As shown in FIG. 35E, when shoulder 1334 of plunger 1304 abuts stop surface 1234 of dosing dock 1200, plunger 1304 may not advance distally relative to barrel 1302. By preventing plunger 1304 from translating distally relative to barrel 1302, shoulder 1334 and stop surface 1234 prevent inadvertent ejection of fluid from barrel 1302, thereby preventing inadvertent ejection of fluid from needle 150, 550, 650, 750, 850, 950, 1050, 1150, and maintaining a predetermined amount of fluid within barrel 1302 and an overall fluid path between barrel 1302 and the distal end of needle 150, 550, 650, 750, 850, 950, 1050, 1150. In some variations, the arrest of distal translation of plunger 1304 relative to barrel 1302 caused by shoulder 1334 abutting stop surface 1234 during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E may provide a positive indication to the surgeon that any air has been purged from the fluid path between barrel 1302 and needle distal end 150, 550, 650, 750, 850, 950, 1050, 1150, and that conduit assembly 140 and instrument 100 are properly primed and that barrel 1302 properly contains a predetermined amount of fluid. For example, the predetermined amount of fluid contained within barrel 1302 when in the state shown in FIG. 35E may correspond to a desired predetermined amount of fluid for subsequent delivery to form lead bleb 340. By way of example only, the predetermined amount of fluid contained within barrel (1302) may range from about 50 microliters to about 300 microliters. In some variations, the predetermined amount of fluid contained within barrel (1302) is about 100 microliters. As another example, the predetermined amount of fluid contained within barrel (1302) may range from about 50 microliters to about 250 microliters. As yet another example, the predetermined amount of fluid contained within barrel (1302) may range from about 50 microliters to about 200 microliters.In this regard, the stop surface (1234) may be longitudinally positioned at a predetermined location relative to one or more portions of the syringe (1300), the instrument (100), and / or the conduit (140), with such predetermined location selected to ensure that any air in the fluid path between the barrel (1302) and the distal end of the needle (150, 550, 650, 750, 850, 950, 1050, 1150) is purged during the transition from the state shown in FIG. 35D to the state shown in FIG. 35E.

[0172] After achieving the state shown in FIG. 35E, the surgeon may complete the steps described above and shown in FIGS. 7A-7E. In this example, the barrel (1302) contains fluid to form the lead bleb (340). To prepare the syringe (1300) for delivering the lead bleb (340), the surgeon may remove the syringe (1300) from the dosing dock (1200) so that the shoulder (1334) can disengage from the stop surface (1234) of the dosing dock (1200), as shown in FIG. 35F. Thus, with the shoulder (1334) disengaged from the stop surface (1234) of the dosing dock (1200), the plunger (1304) can freely advance distally relative to the barrel (1302) from the longitudinal position shown in FIG. 35F. In some cases, the surgeon refrains from removing the syringe (1300) from the administration dock (1200) until the stage of the procedure illustrated in FIG. 7E is reached. In some other cases, the surgeon removes the syringe (1300) from the administration dock (1200) before inserting any portion of the device (100) into the patient's eye (301). For example, in instances where the administration dock (1200) is used with a suprachoroidal delivery device constructed and operative in accordance with at least a portion of the teachings of WO 2022 / 172086, the surgeon may remove the syringe (1300) from the administration dock (1200) before placing the needle of such device into the sclera (304).

[0173] Once the needle (150, 550, 650, 750, 850, 950, 1050, 1150) has traversed the choroid (306) and is positioned to deliver fluid to the subretinal space as shown in FIG. 7E , and the syringe (1300) has been removed from the dock (1200) as shown in FIG. 35F , the surgeon can advance the plunger (1304) distally relative to the barrel (1302) until the shoulder (1334) of the plunger (1304) engages the stop surface (1318) of the barrel (1302). This state is shown in FIG. 35G . As the plunger (1304) moves from the longitudinal position shown in FIG. 35F to the longitudinal position shown in FIG. 35G , the plunger (1304) drives a predetermined amount of fluid from the barrel (1302). For example, the predetermined amount of fluid driven from barrel (1302) during the transition from the state shown in FIG. 35F to the state shown in FIG. 35G may correspond to the desired predetermined amount of fluid to deliver to form the leading bleb (340). By way of example only, the predetermined volume of fluid driven from barrel (1302) may range from approximately 50 microliters to approximately 300 microliters. As another example, the predetermined volume of fluid driven from barrel (1302) may range from approximately 50 microliters to approximately 250 microliters. As yet another example, the predetermined volume of fluid driven from barrel (1302) may range from approximately 50 microliters to approximately 200 microliters. In some variations, the predetermined volume of fluid driven from barrel (1302) is approximately 100 microliters. This provides fluid communication through conduit assembly (140) and associated components of instrument (100), ultimately resulting in delivery of the leading bleb (340), as shown in FIG. The volume of the fluid-formed leading bleb (340) is determined by the vertical distance between the stop surface (1234) of the docking dock (1200) and the stop surface (1318) of the barrel (1302).Because this vertical distance between stop surfaces 1234, 1318 can be fixed and predetermined (e.g., based on where stop surface 1318 is positioned when syringe 1300 is coupled to dock 1200), dock 1200 ensures that syringe 1300 predictably delivers the correct, predetermined amount of fluid for leading bleb 340 on a consistent basis. By way of example only, the predetermined volume of fluid delivered to leading bleb 340 can range from approximately 50 microliters to approximately 300 microliters. As another example, the predetermined volume of fluid delivered to leading bleb 340 can range from approximately 50 microliters to approximately 250 microliters. As yet another example, the predetermined volume of fluid delivered to leading bleb 340 can range from approximately 50 microliters to approximately 200 microliters. In some variations, the predetermined amount of fluid for leading bleb 340 is approximately 100 microliters.

[0174] In some examples, the combination of the second administration dock (1200) and the second syringe (1300) is also in fluid communication with the conduit assembly (140), with the second syringe (1300) containing the therapeutic agent (342). As noted above, both syringes (1300) may be coupled to the conduit assembly (140) via a "Y" fitting or any other suitable component(s), as will be apparent to those skilled in the art in view of the teachings herein. In such a scenario, the combination of the second administration dock (1200) and the second syringe (1300) may undergo the same steps as described above with reference to Figures 35A-35G. However, the plunger (1304) of the second syringe (1300) will not advance from the position shown in Figure 35F to the position shown in Figure 35G until after the plunger (1304) of the first syringe (1300) has advanced from the position shown in Figure 35F to the position shown in Figure 35G, thereby delivering the lead bleb (340). In other words, the plunger (1304) of the second syringe (1300) will not advance from the position shown in Figure 35F to the position shown in Figure 35G to deliver the therapeutic agent (342) into the subretinal space, as shown in Figure 7G, until after the lead bleb (340) has already been delivered, as shown in Figure 7F.

[0175] When two separate combinations of docks (1200) and syringes (1300) are used, one for the leading bleb (340) fluid and the other for the therapeutic agent (342) fluid, the corresponding docks (1200) may have slightly different body portions (1210) to provide different predetermined volumes of delivered fluid. For example, the body portion (1210) used with the syringe (1300) containing the fluid for directing the bleb (340) may be configured to provide delivery of a first predetermined amount of fluid, while the body portion (1210) used with the syringe (1300) containing the therapeutic agent (342) may be configured to provide delivery of a second predetermined amount of fluid. These different body portions (1210) may vary based on the longitudinal positions of their corresponding stop surfaces (1234). In other words, different docks (1200) may vary based on the longitudinal distance between stop surfaces (1234) and (1318), respectively, of the corresponding syringes (1300).

[0176] While the foregoing examples provide use of the administration dock (1200) and syringe (1300) combination in an ophthalmic procedure, the administration dock (1200) and syringe (1300) combination may be used in a variety of other types of medical procedures, including other areas of a patient's anatomy other than the eye (301). Accordingly, it is contemplated that the present invention is not necessarily limited to use in the ophthalmic procedures shown in Figures 7A-7G and described above. Various other suitable scenarios in which the administration dock (1200) may be used will be apparent to those skilled in the art in light of the teachings herein.

[0177] VI. Typical Combinations

[0178] The following examples illustrate various, non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be presented at any time in this application or any subsequent application of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features referred to in the following examples. Accordingly, none of the aspects or features referred to below should be deemed critical unless expressly indicated as such at a later date by the inventor or the inventor's successor in interest. If a claim is presented in this application or any subsequent application related to this application that includes additional features other than those referred to below, those additional features shall not be presumed to have been added for any reasons related to patentability.

[0179] Example 1

[0180] The device includes: (a) a body; (b) a cannula extending distally from the body, the cannula being flexible and dimensioned and configured for advancement between the sclera and choroid of a patient's eye; and (c) a needle slidably disposed within the cannula, the needle having (i) a sharp distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position, the distal tip configured to be inside the cannula when the needle is in the proximal position and the distal tip configured to be outside the cannula when the needle is in the distal position. and a needle including: (i) a sharp distal tip configured to extend along the at least one proximal curve through the at least one proximal curve; and (ii) at least one proximal curve, wherein the needle is resiliently biased to extend along the at least one distal curve through the at least one distal curve, the at least one distal curve being different from the at least one proximal curve.

[0181] Example 2

[0182] The device of Example 1, wherein the needle further includes a distal straight portion extending along the exit axis, the distal straight portion being longitudinally interposed between the at least one distal curved portion and the sharp distal tip, and the needle is resiliently biased to extend along a linear path along the distal straight portion.

[0183] Example 3

[0184] 3. The device of claim 1 or 2, wherein the needle further comprises a proximal straight portion, at least one proximal curved portion longitudinally interposed between the proximal straight portion and the at least one distal curved portion, and the needle is resiliently biased to extend along a linear path along the proximal straight portion.

[0185] Example 4

[0186] 4. The device of any one of Examples 1 to 3, wherein the needle further comprises an intermediate straight portion, the intermediate straight portion being longitudinally interposed between the at least one proximal curved portion and the at least one distal curved portion, and the needle is resiliently biased to extend along a linear path along the intermediate straight portion.

[0187] Example 5

[0188] 5. The device of any one of Examples 1 to 4, wherein the at least one proximal curved portion includes first and second proximal curved portions, and the needle is resiliently biased to extend through and along the first and second proximal curved portions, respectively.

[0189] Example 6

[0190] 6. The device of any one of Examples 1 to 5, wherein the at least one distal curved portion includes first and second distal curved portions, and the needle is resiliently biased to extend through and along the first and second distal curved portions, respectively.

[0191] Example 7

[0192] 7. The device of any one of Examples 1 to 6, wherein at least one proximal curved portion and at least one distal curved portion are curved in opposite directions to each other.

[0193] Example 8

[0194] 8. The device of any one of Examples 1 to 7, wherein the needle is resiliently biased to define an "S" shape.

[0195] Example 9

[0196] 9. The device of any one of Examples 1 to 8, wherein the at least one proximal curved portion is configured to reside within the cannula when the needle is in the distal position.

[0197] Example 10

[0198] 10. The device of any one of Examples 1 to 9, wherein the at least one proximal curve is configured to be located outside the patient's eye when the needle is in the distal position.

[0199] Example 11

[0200] 11. The device of any one of Examples 1 to 10, wherein at least one proximal curved portion is configured to inhibit movement of the body from being transmitted to the distal tip.

[0201] Example 12

[0202] 12. The device of any one of Examples 1 to 11, wherein the at least one proximal curved portion is configured to impart a curvature to the cannula.

[0203] Example 13

[0204] 13. The device of any one of Examples 1 to 12, wherein the needle comprises nitinol.

[0205] Example 14

[0206] 14. The device of any one of Examples 1 to 13, wherein the distal tip is beveled.

[0207] Example 15

[0208] 15. The device of any one of Examples 1 to 14, wherein the cannula is sufficiently flexible to conform to the anatomy and contours of the patient's eye, yet the cannula has sufficient column strength to allow advancement of the cannula between the sclera and choroid of the patient's eye without buckling.

[0209] Example 16

[0210] The device includes: (a) a body; (b) a cannula extending distally from the body, the cannula being flexible and dimensioned and configured for advancement between the sclera and choroid of a patient's eye; and (c) a needle slidably disposed within the cannula, the needle having (i) a sharp distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position such that the distal tip is located inside the cannula when the needle is in the proximal position. a sharpened distal tip configured to lie outside the cannula when the needle is in a distal position; and a needle including: (ii) a first curved portion, wherein the needle is resiliently biased to extend through the first curve along a first curve; and (iii) a second curved portion, longitudinally spaced from the first curved portion, wherein the needle is resiliently biased to extend through the second curve along a second curve.

[0211] Example 17

[0212] 1. A device comprising: (a) a body; (b) a cannula extending distally from the body, the cannula being flexible and dimensioned and configured for advancement between the sclera and choroid of a patient's eye, the cannula including: (i) a proximal segment having a first cross-sectional area; (ii) an intermediate segment having a second cross-sectional area; and (iii) a distal segment having a third cross-sectional area greater than the second cross-sectional area; and (c) a needle slidably disposed within the cannula.

[0213] Example 18

[0214] 18. The apparatus of example 17, wherein the second cross-sectional area is smaller than the first cross-sectional area.

[0215] Example 19

[0216] The device of Example 17 or 18, wherein the proximal segment has a first cross-sectional shape, the intermediate segment has a second cross-sectional shape, and the distal segment has a third cross-sectional shape different from the second cross-sectional shape.

[0217] Example 20

[0218] 20. The device of any one of Examples 17 to 19, wherein the cannula further comprises a wedge-shaped distal end.

[0219] Example 21

[0220] 21. The device of any one of Examples 17 to 20, wherein the proximal segment has a first stiffness and the intermediate segment has a second stiffness different from the first stiffness.

[0221] Example 22

[0222] 22. The device of example example 21, wherein the distal segment has a third stiffness different from the second stiffness.

[0223] Example 23

[0224] 1. A device comprising: (a) a body; (b) a cannula extending distally from the body along a length, the cannula being flexible, the cannula being dimensioned and configured for advancement between the sclera and choroid of a patient's eye, the cannula having a stiffness that varies along its length; and (c) a needle slidably disposed within the cannula.

[0225] Example 24

[0226] The cannula comprises: (i) a proximal segment having a first stiffness; (ii) an intermediate segment having a second stiffness different from the first stiffness; and (iii) a distal segment having a third stiffness different from the second stiffness. 24. The device of Example 23, comprising:

[0227] Example 25

[0228] The device comprises: (a) a body portion including: (i) a proximal channel extending along a longitudinal axis and configured to slidably receive a plunger of a syringe; and (ii) a first stop surface disposed at a fixed position proximal to the proximal channel, the first stop surface facing proximally and configured to selectively engage the plunger of the syringe to stop distal advancement of the plunger relative to the barrel of the syringe; and (b) a first stop surface disposed distal to the proximal channel and on first and second sides of the longitudinal axis, respectively. and (c) first and second deflectable flanges disposed distally of the first and second beams on first and second sides of the longitudinal axis, respectively, the first and second flanges configured to cooperate with each other to grip the barrel of the syringe.

[0229] Example 26

[0230] The device of Example 25, further comprising a handle portion disposed distally of the body portion, the handle portion including at least one finger flange extending laterally outward relative to the longitudinal axis and configured to be grasped by a user.

[0231] Example 27

[0232] 27. The device of example embodiment 26, wherein the handle portion comprises first and second beams.

[0233] Example 28

[0234] An apparatus as described in any of Examples 26-27, further comprising a support portion disposed distal to the handle portion, the support portion including an elongated arm and a cradle at the distal end of the elongated arm.

[0235] Example 29

[0236] 29. The apparatus of example 28, wherein the support portion comprises first and second flanges.

[0237] Example 30

[0238] An apparatus described in any of Examples 28-29, wherein the cradle includes a distal channel extending along the longitudinal axis and configured to receive the barrel of a syringe.

[0239] Example 31

[0240] The device of any of Examples 24 to 30, wherein the body portion further includes a proximal recess positioned proximal to the proximal channel to define a first stop surface.

[0241] Example 32

[0242] A device described in any of Examples 24 to 31, wherein the body portion further includes an intermediate recess disposed distal to the proximal channel, the intermediate recess configured to receive the barrel of a syringe.

[0243] Example 33

[0244] A device described in any of Examples 24 to 32, wherein the body portion further includes at least one distal recess positioned distal to the proximal channel, the at least one distal recess configured to receive at least one finger flange of the syringe.

[0245] Example 34

[0246] The device of any of Examples 24 to 33, further comprising a first detent and a second detent extending laterally inward from the first beam and the second beam, respectively, relative to the longitudinal axis, the first detent and the second detent being configured to frictionally engage with the barrel of the syringe.

[0247] Example 35

[0248] A device described in any of Examples 24 to 34, further comprising first and second detents extending laterally inward from the first and second flanges, respectively, relative to the longitudinal axis, the first and second detents being configured to frictionally engage with the barrel of the syringe.

[0249] Example 36

[0250] 36. The apparatus of any of Examples 24-35, wherein the first beam and the second beam are configured to deflect laterally away from each other from their respective undeflected states toward their respective deflected states, and the first beam and the second beam are elastically biased toward their respective undeflected states.

[0251] Example 37

[0252] 37. The apparatus of any of Examples 24-36, wherein the first and second flanges are configured to deflect laterally away from one another from their respective undeflected states toward their respective deflected states, and the first and second beams are resiliently biased toward their respective undeflected states.

[0253] Example 38

[0254] The device of any of Examples 24 to 37, further comprising a syringe, the syringe comprising: (i) a barrel having a second stop surface disposed distal to the first stop surface; and (ii) a plunger slidably disposed within the barrel and configured to selectively engage each of the first and second stop surfaces.

[0255] Example 39

[0256] 39. The device of Example 38, wherein the plunger is slidably received by the proximal channel.

[0257] Example 40

[0258] 39. The apparatus of any of Examples 38-39, wherein the barrel is firmly gripped by the first and second beams.

[0259] Example 41

[0260] 41. The apparatus of any of Examples 38-40, wherein the barrel is firmly gripped by the first and second flanges.

[0261] Example 42

[0262] 42. The device of any of Examples 38-41, further comprising a delivery device comprising: (i) a flexible cannula configured to fit between the choroid and the sclera of the patient's eye; and (ii) a needle slidably disposed within the cannula, the needle defining a lumen in fluid communication with the barrel of the syringe.

[0263] Example 43

[0264] 43. The device of Example 42, wherein the plunger is configured to drive approximately 100 microliters of fluid from the barrel to the distal tip of the needle.

[0265] Example 44

[0266] A system comprising: (a) a delivery device having a distal end; (b) a syringe including (i) a barrel and (ii) a plunger slidably disposed within the barrel; (c) a fluid pathway extending between the barrel and the distal end of the device; and (d) an administration dock including: (i) a receptacle configured to receive the barrel of the syringe; and (ii) a stop surface disposed at a fixed position proximal to the receptacle, the stop surface facing proximally; wherein the plunger is configured to advance distally relative to the barrel from a first longitudinal position to a second longitudinal position, thereby purging any air from the fluid pathway; and the stop surface is configured to selectively engage the plunger of the syringe to prevent distal advancement of the plunger relative to the barrel beyond the second longitudinal position.

[0267] Example 45

[0268] A method of operating a system, the system including: (i) a dosing dock including (A) a receptacle and (B) a first stop surface; and (ii) a syringe including (A) a barrel having a second stop surface and (B) a plunger slidably disposed within the barrel, the method including: (a) proximally retracting the plunger relative to the barrel to a first longitudinal position, thereby drawing fluid from a fluid source into the barrel; (b) inserting the barrel of the syringe into the receptacle of the dosing dock; (c) disconnecting the fluid source from the barrel; (d) coupling the barrel to an instrument; and (e) with the barrel of the syringe disposed in the receptacle of the dosing dock and coupled to the instrument, advancing the plunger distally relative to the barrel to a second longitudinal position, thereby retracting the barrel and the instrument. (f) advancing the plunger to a second longitudinal position, where any air is purged from the fluid path between the barrel and the distal end, and the plunger engages a first stop surface at the second longitudinal position, the first stop surface preventing further distal advancement of the plunger relative to the barrel; (f) removing the syringe barrel from the receptacle of the dosing dock; and (g) with the syringe barrel removed from the receptacle of the dosing dock and coupled to the device, advancing the plunger distally relative to the barrel to a third longitudinal position, whereby fluid is dispensed from the barrel through the distal end of the device, and the plunger engages a second stop surface at the third longitudinal position, the second stop surface preventing further distal advancement of the plunger relative to the barrel.

[0269] VII. Other

[0270] While some examples herein are described in the context of a cannula guide positioned near an already-formed sclerotomy (23), it should be understood that other types of procedures may be used. For example, in some variations of the procedures described herein, a cannula guide may be secured to the eye (20) first, and then the sclerotomy (23) may be formed after the cannula guide is secured to the eye (20). Other suitable steps and sequences that may be performed in a procedure involving the combination of a sclerotomy (23) and a cannula guide will be apparent to those skilled in the art in view of the teachings herein.

[0271] It should be understood that any of the versions of the instruments described herein may include various other features in addition to or in place of those described above. By way of example only, any of the devices herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0272] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the foregoing teachings, expressions, embodiments, examples, etc. should not be viewed in isolation from one another. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0273] Any patent, publication, or other disclosure material that is said to be incorporated by reference herein should be understood to be incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. Thus, to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated herein by reference but that contradicts existing definitions, descriptions, or other disclosure material set forth herein is incorporated only to the extent that no contradiction arises between the incorporated material and the existing disclosure material.

[0274] The above versions may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either or both cases, the versions may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of particular parts or portions of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some versions of the device may be reassembled for subsequent use at a reconditioning facility or by a surgeon immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0275] By way of example only, the versions described herein may be sterilized before and / or after treatment. In one sterilization technique, the device is placed in a closed, sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

[0276] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some such potential modifications have been mentioned above, and others will be apparent to those skilled in the art. For example, the foregoing examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. are illustrative and not required. Accordingly, the scope of the present invention should be considered in terms of the following claims, and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

[0277] [Embodiment] (1) A device comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being sized and configured to be advanced between the sclera and the choroid of the patient's eye; (c) a needle slidably disposed within the cannula, (i) a sharpened distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position, the distal tip configured to be located inside the cannula when the needle is in the proximal position and the distal tip configured to be located outside the cannula when the needle is in the distal position; (ii) at least one proximal curve, wherein the needle is resiliently biased to extend through and along the at least one proximal curve; (iii) at least one distal curve, wherein the needle is resiliently biased to extend along at least one distal curve through the at least one distal curve, the at least one distal curve being different from the at least one proximal curve; needles including An apparatus comprising: (2) The device of embodiment 1, wherein the needle further includes a distal straight portion extending along the exit axis, the distal straight portion being longitudinally interposed between the at least one distal curved portion and the sharp distal tip, and the needle is resiliently biased to extend along a linear path along the distal straight portion. (3) The device of any one of claims 1 to 2, wherein the needle further comprises a proximal straight portion, the at least one proximal curved portion being longitudinally interposed between the proximal straight portion and the at least one distal curved portion, and the needle is resiliently biased to extend along a linear path along the proximal straight portion. (4) The device of any one of claims 1 to 3, wherein the needle further comprises an intermediate straight portion, the intermediate straight portion being longitudinally interposed between the at least one proximal curved portion and the at least one distal curved portion, and the needle is resiliently biased to extend along a linear path along the intermediate straight portion. (5) The device of any one of embodiments 1 to 4, wherein the at least one proximal curved portion includes first and second proximal curved portions, and the needle is resiliently biased to extend through the first and second proximal curved portions and along the first and second proximal curved portions, respectively.

[0278] (6) The device of any one of claims 1 to 5, wherein the at least one distal curved portion includes first and second distal curved portions, and the needle is resiliently biased to extend through the first and second distal curved portions and along the first and second distal curved portions, respectively. (7) The device according to any one of embodiments 1 to 6, wherein the at least one proximal curved portion and the at least one distal curved portion are curved in opposite directions to each other. (8) The device of any one of claims 1 to 7, wherein the needle is resiliently biased to define an "S" shape. (9) The device according to any one of embodiments 1 to 8, wherein the at least one proximal curved portion is configured to be located within the cannula when the needle is in the distal position. (10) The device of any one of embodiments 1 to 9, wherein the at least one proximal curved portion is configured to be positioned outside the patient's eye when the needle is in the distal position.

[0279] (11) A device according to any one of embodiments 1 to 10, wherein the at least one proximal curved portion is configured to inhibit movement of the main body from being transmitted to the distal tip. (12) The device described in any one of embodiments 1 to 11, wherein the at least one proximal curved portion is configured to impart a curvature to the cannula. (13) The device of any one of embodiments 1 to 12, wherein the needle comprises nitinol. (14) The device of any one of embodiments 1 to 13, wherein the distal tip is beveled. (15) The device of any one of claims 1 to 14, wherein the cannula is sufficiently flexible to conform to the anatomy and contours of the patient's eye, yet has sufficient column strength to permit advancement of the cannula between the sclera and the choroid of the patient's eye without buckling.

[0280] (16) An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being sized and configured to be advanced between the sclera and the choroid of the patient's eye; (c) a needle slidably disposed within the cannula, (i) a sharpened distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position, the distal tip configured to be located inside the cannula when the needle is in the proximal position and the distal tip configured to be located outside the cannula when the needle is in the distal position; (ii) a first curved portion, the needle being resiliently biased to extend through the first curved portion along a first curve; (iii) a second curved portion longitudinally spaced from the first curved portion, the needle being resiliently biased to extend through the second curved portion along a second curve; Including needles and An apparatus comprising: (17) An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and the choroid of the patient's eye, the cannula comprising: (i) a proximal segment having a first cross-sectional area; (ii) an intermediate segment having a second cross-sectional area; (iii) a distal segment having a third cross-sectional area greater than the second cross-sectional area; a cannula including: (c) a needle slidably disposed within the cannula; An apparatus comprising: (18) The device of embodiment 17, wherein the second cross-sectional area is smaller than the first cross-sectional area. (19) The device described in embodiment 17 or 18, wherein the proximal segment has a first cross-sectional shape, the intermediate segment has a second cross-sectional shape, and the distal segment has a third cross-sectional shape different from the second cross-sectional shape. (20) The device described in any one of embodiments 17 to 19, wherein the cannula further comprises a wedge-shaped distal end.

[0281] (21) The device described in any one of embodiments 17 to 20, wherein the proximal segment has a first stiffness and the intermediate segment has a second stiffness different from the first stiffness. (22) The device described in embodiment 21, wherein the distal segment has a third stiffness different from the second stiffness. (23) An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body along a length, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and choroid of a patient's eye, the cannula having a stiffness that varies along the length; (c) a needle slidably disposed within the cannula; An apparatus comprising: (24) The cannula comprises: (i) a proximal segment having a first stiffness; (ii) an intermediate segment having a second stiffness different from the first stiffness; (iii) a distal segment having a third stiffness different from the second stiffness; and 24. The device of embodiment 23, comprising: (25) An apparatus comprising: (a) a main body portion, (i) a proximal channel extending along the longitudinal axis and configured to slidably receive a plunger of a syringe; (ii) a first stop surface disposed at a fixed location proximal to the proximal channel, the first stop surface facing proximally and configured to selectively engage the plunger of the syringe to stop distal advancement of the plunger relative to the barrel of the syringe; a body portion including: (b) first and second deflectable beams disposed distally of the proximal channel and on first and second sides of the longitudinal axis, respectively, the first and second beams configured to cooperate with one another to firmly grip the barrel of the syringe; (c) first and second deflectable flanges disposed distally of the first and second beams on the first and second sides of the longitudinal axis, respectively, the first and second flanges configured to cooperate with one another to grip the barrel of the syringe; and An apparatus comprising:

[0282] (26) The device of claim 25, further comprising a handle portion disposed distally of the body portion, the handle portion including at least one finger flange extending laterally outward relative to the longitudinal axis and configured to be grasped by a user. (27) The device of claim 26, wherein the handle portion includes the first and second beams. (28) The device of any one of claims 26 to 27, further comprising a support portion disposed distally of the handle portion, the support portion including an elongated arm and a cradle at the distal end of the elongated arm. (29) The device described in embodiment 28, wherein the support portion includes the first and second flanges. (30) The device of embodiment 28 or 29, wherein the cradle includes a distal channel extending along the longitudinal axis and configured to receive the barrel of the syringe.

[0283] (31) The device described in any one of embodiments 24 to 30, wherein the body portion further includes a proximal recess disposed proximal to the proximal channel to define the first stop surface. (32) The device described in any one of embodiments 24 to 31, wherein the body portion further includes an intermediate recess disposed distal to the proximal channel, the intermediate recess configured to receive the barrel of the syringe. (33) The device described in any one of embodiments 24 to 32, wherein the body portion further includes at least one distal recess disposed distal to the proximal channel, the at least one distal recess configured to receive at least one finger flange of the syringe. (34) The device described in any one of embodiments 24 to 33, further comprising first and second detents extending laterally inward from the first beam and the second beam, respectively, relative to the longitudinal axis, the first and second detents configured to frictionally engage the barrel of the syringe. (35) The device of any one of embodiments 24 to 34, further comprising first and second detents extending laterally inward from the first and second flanges, respectively, relative to the longitudinal axis, the first and second detents configured to frictionally engage the barrel of the syringe.

[0284] (36) A device described in any of embodiments 24 to 35, wherein the first beam and the second beam are configured to deflect laterally away from each other from their respective undeflected states toward their respective deflected states, and the first beam and the second beam are elastically biased toward their respective undeflected states. (37) The device described in any one of embodiments 24 to 36, wherein the first and second flanges are configured to deflect laterally away from each other from their respective undeflected states toward their respective deflected states, and the first and second beams are elastically biased toward their respective undeflected states. (38) The method further includes a syringe, (i) a barrel having a second stop surface disposed distally of the first stop surface; (ii) a plunger slidably disposed within the barrel and configured to selectively engage each of the first and second stop surfaces; An apparatus described in any one of embodiments 24 to 37, comprising: (39) The device of embodiment 38, wherein the plunger is slidably received by the proximal channel. (40) The apparatus of any one of claims 38 to 39, wherein the barrel is firmly gripped by the first and second beams.

[0285] (41) The device described in any one of embodiments 38 to 40, wherein the barrel is firmly gripped by the first and second flanges. (42) Further comprising a delivery device, the delivery device comprising: (i) a flexible cannula configured to fit between the choroid and the sclera of the patient's eye; (ii) a needle slidably disposed within the cannula, the needle defining a lumen in fluid communication with the barrel of the syringe; An apparatus described in any one of embodiments 38 to 41, comprising: (43) The device of embodiment 42, wherein the plunger is configured to drive approximately 100 microliters of fluid from the barrel to the distal tip of the needle. (44) A system comprising: (a) a delivery device having a distal end; (b) a syringe, (i) a barrel; (ii) a plunger slidably disposed within the barrel; a syringe comprising: (c) a fluid pathway extending between the barrel and the distal end of the instrument; (d) an administration dock, (i) a receptacle configured to receive the barrel of the syringe; (ii) a stop surface disposed at a proximal, fixed location of the receptacle, the stop surface facing proximally; and Including, administration dock and Equipped with The system includes a plunger configured to advance distally relative to the barrel from a first longitudinal position to a second longitudinal position, thereby purging any air from the fluid path, and a stop surface configured to selectively engage the plunger of the syringe to prevent distal advancement of the plunger relative to the barrel beyond the second longitudinal position. (45) A method of operating a system, the system including: (i) a dispensing dock including (A) a receptacle and (B) a first stop surface; and (ii) a syringe including (A) a barrel having a second stop surface and (B) a plunger slidably disposed within the barrel, the method comprising: (a) proximally retracting the plunger relative to the barrel to a first longitudinal position, thereby drawing fluid from a fluid source into the barrel; (b) inserting the barrel of the syringe into the receptacle of the administration dock; (c) disconnecting the fluid source from the barrel; (d) coupling the barrel to an instrument; (e) with the barrel of the syringe disposed within the receptacle of the docking dock and coupled to the device, advancing the plunger distally relative to the barrel to a second longitudinal position, whereby any air is purged from a fluid path between the barrel and the distal end of the device, and where the plunger engages the first stop surface, which prevents further distal advancement of the plunger relative to the barrel; (f) removing the barrel of the syringe from the receptacle of the administration dock; (g) with the barrel of the syringe removed from the receptacle of the docking dock and coupled to the device, advancing the plunger distally relative to the barrel to a third longitudinal position, whereby the fluid is dispensed from the barrel through the distal end of the device and the plunger engages the second stop surface at the third longitudinal position, the second stop surface preventing further distal advancement of the plunger relative to the barrel; A method comprising:

Claims

1. 1. An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and the choroid of the patient's eye; (c) a needle slidably disposed within the cannula, (i) a sharpened distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position, the distal tip configured to be located inside the cannula when the needle is in the proximal position and the distal tip configured to be located outside the cannula when the needle is in the distal position; (ii) at least one proximal curve, wherein the needle is resiliently biased to extend through and along the at least one proximal curve; (iii) at least one distal curve, wherein the needle is resiliently biased to extend along the at least one distal curve through the at least one distal curve, the at least one distal curve being different from the at least one proximal curve; needles including An apparatus comprising:

2. 10. The device of claim 1, wherein the needle further includes a distal straight portion extending along an exit axis, the distal straight portion being longitudinally interposed between the at least one distal curved portion and the sharp distal tip, and the needle is resiliently biased to extend along a linear path along the distal straight portion.

3. 3. The device of claim 1, wherein the needle further comprises a proximal straight portion, the at least one proximal curved portion being longitudinally interposed between the proximal straight portion and the at least one distal curved portion, and the needle is resiliently biased to extend along a linear path along the proximal straight portion.

4. 10. The device of claim 1, wherein the needle further includes an intermediate straight portion longitudinally interposed between the at least one proximal curved portion and the at least one distal curved portion, the needle being resiliently biased to extend along a linear path along the intermediate straight portion.

5. 2. The device of claim 1, wherein the at least one proximal curved portion includes first and second proximal curved portions, and the needle is resiliently biased to extend through and along the first and second proximal curves, respectively.

6. 10. The device of claim 1, wherein the at least one distal curved portion includes first and second distal curved portions, and the needle is resiliently biased to extend through and along the first and second distal curved portions, respectively.

7. The device of claim 1 , wherein the at least one proximal curved portion and the at least one distal curved portion are curved in opposite directions.

8. The device of claim 1 , wherein the needle is resiliently biased to define an "S" shape.

9. The device of claim 1 , wherein the at least one proximal curve is configured to reside within the cannula when the needle is in the distal position.

10. The device of claim 1 , wherein the at least one proximal curve is configured to be located outside the patient's eye when the needle is in the distal position.

11. The device of claim 1 , wherein the at least one proximal curved portion is configured to inhibit movement of the body from being transmitted to the distal tip.

12. The device of claim 1 , wherein the at least one proximal curve is configured to impart a curvature to the cannula.

13. The device of claim 1 , wherein the needle comprises nitinol.

14. The device of claim 1 , wherein the distal tip is beveled.

15. 10. The device of claim 1, wherein the cannula is sufficiently flexible to conform to the anatomy and contours of the patient's eye, yet the cannula has sufficient column strength to allow advancement of the cannula between the sclera and the choroid of the patient's eye without buckling.

16. 1. An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and the choroid of the patient's eye; (c) a needle slidably disposed within the cannula, (i) a sharpened distal tip, the needle configured to translate relative to the cannula between a proximal position and a distal position, the distal tip configured to be located inside the cannula when the needle is in the proximal position and the distal tip configured to be located outside the cannula when the needle is in the distal position; (ii) a first curved portion, the needle being resiliently biased to extend through the first curved portion along a first curve; (iii) a second curved portion longitudinally spaced from the first curved portion, the needle being resiliently biased to extend through the second curved portion along a second curve; Including needles and An apparatus comprising:

17. 1. An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and the choroid of the patient's eye, the cannula comprising: (i) a proximal segment having a first cross-sectional area; (ii) an intermediate segment having a second cross-sectional area; (iii) a distal segment having a third cross-sectional area greater than the second cross-sectional area; a cannula including: (c) a needle slidably disposed within the cannula; An apparatus comprising:

18. 18. The apparatus of claim 17, wherein the second cross-sectional area is smaller than the first cross-sectional area.

19. 19. The device of claim 17 or 18, wherein the proximal segment has a first cross-sectional shape, the intermediate segment has a second cross-sectional shape, and the distal segment has a third cross-sectional shape different from the second cross-sectional shape.

20. The device of claim 17 , wherein the cannula further comprises a wedge-shaped distal end.

21. 18. The device of claim 17, wherein the proximal segment has a first stiffness and the intermediate segment has a second stiffness different from the first stiffness.

22. 22. The device of claim 21, wherein the distal segment has a third stiffness different from the second stiffness.

23. 1. An apparatus comprising: (a) a main body; (b) a cannula extending distally from the body along a length, the cannula being flexible, the cannula being dimensioned and configured to be advanced between the sclera and choroid of a patient's eye, the cannula having a stiffness that varies along the length; (c) a needle slidably disposed within the cannula; An apparatus comprising:

24. The cannula comprises: (i) a proximal segment having a first stiffness; (ii) an intermediate segment having a second stiffness different from the first stiffness; (iii) a distal segment having a third stiffness different from the second stiffness; 24. The apparatus of claim 23, comprising:

25. 1. An apparatus comprising: (a) a body portion, (i) a proximal channel extending along the longitudinal axis and configured to slidably receive a plunger of a syringe; (ii) a first stop surface disposed at a fixed location proximal to the proximal channel, the first stop surface facing proximally and configured to selectively engage the plunger of the syringe to stop distal advancement of the plunger relative to the barrel of the syringe; a body portion including: (b) first and second deflectable beams disposed distally of the proximal channel and on first and second sides of the longitudinal axis, respectively, the first and second beams configured to cooperate with one another to firmly grip the barrel of the syringe; (c) first and second deflectable flanges disposed distally of the first and second beams on the first and second sides of the longitudinal axis, respectively, the first and second flanges configured to cooperate with one another to grip the barrel of the syringe; and An apparatus comprising:

26. 26. The device of claim 25, further comprising a handle portion disposed distally of the body portion, the handle portion including at least one finger flange extending laterally outward relative to the longitudinal axis and configured to be grasped by a user.

27. 27. The device of claim 26, wherein the stem portion includes the first and second beams.

28. 28. The device of claim 26 or 27, further comprising a support portion disposed distally of the handle portion, the support portion including an elongate arm and a cradle at the distal end of the elongate arm.

29. 30. The apparatus of claim 28, wherein the support portion includes the first and second flanges.

30. 30. The device of claim 28, wherein the cradle includes a distal channel extending along the longitudinal axis and configured to receive the barrel of the syringe.

31. 25. The device of claim 24, wherein the body portion further includes a proximal recess disposed proximal to the proximal channel to define the first stop surface.

32. 25. The device of claim 24, wherein the body portion further includes an intermediate recess disposed distally of the proximal channel, the intermediate recess configured to receive the barrel of the syringe.

33. 25. The device of claim 24, wherein the body portion further includes at least one distal recess disposed distally of the proximal channel, the at least one distal recess configured to receive at least one finger flange of the syringe.

34. 25. The device of claim 24, further comprising first and second detents extending laterally inward from the first and second beams, respectively, relative to the longitudinal axis, the first and second detents configured to frictionally engage the barrel of the syringe.

35. 25. The device of claim 24, further comprising first and second detents extending laterally inward from the first and second flanges, respectively, relative to the longitudinal axis, the first and second detents configured to frictionally engage the barrel of the syringe.

36. 25. The apparatus of claim 24, wherein the first beam and the second beam are configured to deflect laterally away from each other from a respective undeflected state toward a respective deflected state, and the first beam and the beam are elastically biased toward their respective undeflected states.

37. 25. The apparatus of claim 24, wherein the first and second flanges are configured to deflect laterally away from one another from a respective undeflected state toward a respective deflected state, and the first and second beams are resiliently biased toward their respective undeflected states.

38. The syringe further comprises: (i) a barrel having a second stop surface disposed distally of the first stop surface; (ii) a plunger slidably disposed within the barrel and configured to selectively engage each of the first and second stop surfaces; 25. The apparatus of claim 24, comprising:

39. 39. The device of claim 38, wherein the plunger is slidably received by the proximal channel.

40. 40. The apparatus of claim 38 or 39, wherein the barrel is firmly gripped by the first and second beams.

41. 39. The apparatus of claim 38, wherein the barrel is firmly gripped by the first and second flanges.

42. Further comprising a delivery device, the delivery device comprising: (i) a flexible cannula configured to fit between the choroid and the sclera of the patient's eye; (ii) a needle slidably disposed within the cannula, the needle defining a lumen in fluid communication with the barrel of the syringe; and 39. The apparatus of claim 38, comprising:

43. 43. The device of claim 42, wherein the plunger is configured to drive approximately 100 microliters of fluid from the barrel to the distal tip of the needle.

44. 1. A system comprising: (a) a delivery device having a distal end; (b) a syringe, (i) a barrel; (ii) a plunger slidably disposed within the barrel; and a syringe comprising: (c) a fluid pathway extending between the barrel and the distal end of the instrument; (d) an administration dock, (i) a receptacle configured to receive the barrel of the syringe; (ii) a stop surface disposed at a proximal, fixed location of the receptacle, the stop surface facing proximally; and Including, administration dock and Equipped with the plunger is configured to advance distally relative to the barrel from a first longitudinal position to a second longitudinal position, thereby purging any air from the fluid path, and the stop surface is configured to selectively engage the plunger of the syringe to prevent distal advancement of the plunger relative to the barrel beyond the second longitudinal position.

45. 1. A method of operating a system, the system including: (i) a dispensing dock including (A) a receptacle and (B) a first stop surface; and (ii) a syringe including (A) a barrel having a second stop surface and (B) a plunger slidably disposed within the barrel, the method comprising: (a) proximally retracting the plunger relative to the barrel to a first longitudinal position, thereby drawing fluid from a fluid source into the barrel; (b) inserting the barrel of the syringe into the receptacle of the administration dock; (c) disconnecting the fluid source from the barrel; (d) coupling the barrel to an instrument; (e) with the barrel of the syringe disposed within the receptacle of the docking station and coupled to the device, advancing the plunger distally relative to the barrel to a second longitudinal position, whereby any air is purged from a fluid path between the barrel and the distal end of the device, and the plunger engages the first stop surface at the second longitudinal position, the first stop surface preventing further distal advancement of the plunger relative to the barrel; (f) removing the barrel of the syringe from the receptacle of the administration dock; (g) with the barrel of the syringe removed from the receptacle of the docking dock and coupled to the device, advancing the plunger distally relative to the barrel to a third longitudinal position, whereby the fluid is dispensed from the barrel through the distal end of the device and the plunger engages the second stop surface at the third longitudinal position, the second stop surface preventing further distal advancement of the plunger relative to the barrel; A method comprising:

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