Trans-vitreous subretinal syringe

Abstract

A device is provided that includes a body and an outer cannula extending distally from the body along a longitudinal axis and securely secured to the body. The outer cannula includes a proximal portion having a first cross-sectional dimension and a distal portion having a second cross-sectional dimension that is smaller than the first cross-sectional dimension. The distal portion is configured to guide the cylindrical proximal portion into a trocar port. The device also includes an inner cannula slidably disposed in the outer cannula for longitudinal translation relative to the outer cannula. The cannula includes an open proximal end, an open distal end configured to pierce a retina of the eye, and a lumen extending between the open proximal end and the open distal end. The lumen is configured to deliver fluid from the open proximal end to the open distal end to deliver the fluid into a subretinal region of the eye.

Description

[0001] priority

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 388,150, filed on July 11, 2022, entitled “Transvitreal Subretinal Injector,” the disclosure of which is incorporated herein by reference. Background Art

[0003] The human eye consists of several layers. The white outer layer is the sclera, which surrounds the choroid layer. The retina is located inside the choroid layer. The sclera contains collagen and elastic fibers that provide protection for the choroid and retina. The choroid layer includes a vasculature that provides oxygen and nutrients to the retina. The retina includes light-sensitive tissue, including rods and cones. The macula is located in the center of the retina at the back of the eye, generally centered on an axis that passes through the center of the eye's lens and cornea (i.e., the optical axis). The macula provides central vision, particularly through cones.

[0004] Macular degeneration is a medical condition that affects the macula, such that a person with it may experience a loss or degeneration of central vision while retaining a certain degree of peripheral vision. Macular degeneration may be caused by a variety of factors, such as age (also known as "AMD") and genetics. Macular degeneration may occur in a "dry" (non-exudative) form, in which cellular debris called drusen accumulate between the retina and the choroid, resulting in areas of geographic atrophy. Macular degeneration may also occur in a "wet" (exudative) form, in which blood vessels grow out of the choroid behind the retina. Although a person with macular degeneration may retain a certain degree of peripheral vision, the loss of central vision may have a huge negative impact on quality of life. In addition, the quality of the remaining peripheral vision may decrease, and in some cases may also disappear. Therefore, it may be necessary to provide treatment for macular degeneration in order to prevent or reverse the vision loss caused by macular degeneration. In some cases, it may be necessary to provide such treatment near the macula in a highly localized manner, such as by delivering a therapeutic substance in the subretinal layers (below the neurosensory layer of the retina and above the retinal pigment epithelium) directly adjacent to the area of ​​geographic atrophy. However, because the macula is located at the back of the eye and beneath a delicate layer of the retina, it can be difficult to access in a practical manner.

[0005] While a variety of surgical methods and instruments have been made and used to treat the eye, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] While the specification concludes with claims that particularly point out and distinctly claim the technology, it is believed that the technology will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals represent like elements and wherein:

[0007] FIG1 depicts a perspective view of an example of an apparatus for delivering a therapeutic agent to the subretinal space;

[0008] FIG2A depicts a side view of the device of FIG1 with the retinal penetrating element in a retracted position;

[0009] FIG2B depicts a side view of the device of FIG1 with the retinal penetrating element in an extended position;

[0010] FIG3 depicts a top view of a patient's eye with the surrounding structures of the eye fixed and three ports installed;

[0011] FIG4A depicts a cross-sectional view of the eye of FIG3 , the section being taken along line 4A- 4A of FIG3 .

[0012] FIG4B depicts a cross-sectional view of the eye of FIG3 , the section taken along line 4B-4B of FIG3 , showing the outer cannula of the apparatus of FIG1 inserted into the trocar port;

[0013] FIG4C depicts a cross-sectional view of the eye of FIG3 , the section being taken along line 4B-4B of FIG3 , showing the retinal penetrating element of the device of FIG1 piercing the retina of the eye to determine a subretinal entry point;

[0014] FIG4D depicts a cross-sectional view of the eye of FIG3 , the section being taken along line 4B-4B of FIG3 , showing the injection of a bubble fluid into the subretinal space of the eye through the retinal penetrating element of the device of FIG1 to form a guide bubble;

[0015] FIG4E depicts a cross-sectional view of the eye of FIG3 , wherein the section is taken along line 4B-4B of FIG3 , illustrating advancement of the retinal penetrating element of the device of FIG1 between the guide bubble and the choroid of the eye;

[0016] FIG4F depicts a cross-sectional view of the eye of FIG3 , wherein the section is taken along line 4B-4B of FIG3 , showing the retinal penetrating element of the device of FIG1 entering the cavity between the retina and the choroid through the guide bubble, and further showing the therapeutic fluid injected into the subretinal space through the retinal penetrating element;

[0017] FIG4G depicts a cross-sectional view of the eye of FIG3 , the section being taken along line 4B-4B of FIG3 , showing the retinal penetrating element of the device of FIG1 retracted toward the subretinal entry point;

[0018] FIG4H depicts a cross-sectional view of the eye of FIG3, the section taken along line 4B-4B of FIG3, showing the suction guide bubble being drawn through the retinal penetrating element of the device of FIG1;

[0019] FIG4I depicts a cross-sectional view of the eye of FIG3 , the section taken along line 4B-4B of FIG3 , showing the instrument of FIG1 removed from the trocar port;

[0020] FIG4J depicts a cross-sectional view of the eye of FIG3 , the section being taken along line 4B-4B of FIG3 , illustrating closure of the subretinal entry point;

[0021] FIG5 depicts an exploded perspective view of an example of a system for delivering a therapeutic agent to the subretinal space, the system comprising a fluid injection device, a fluid source assembly, and a pressure controlled delivery assembly;

[0022] FIG6 depicts an exploded perspective view of the fluid injection apparatus of FIG5;

[0023] FIG7 depicts an exploded perspective view of a portion of a fluid supply assembly and a portion of an actuation assembly of the fluid injection device of FIG5 ;

[0024] FIG8 depicts a perspective view of a portion of the actuation assembly of the fluid injection device of FIG5;

[0025] FIG9A depicts a side view of the fluid injection device of FIG5 with the retinal penetrating element in a retracted position;

[0026] FIG9B depicts a side view of the fluid injection device of FIG5 with the retinal penetrating element in an extended position;

[0027] FIG10A depicts a cross-sectional view of the fluid injection device of FIG5 with the retinal penetrating element in a retracted position;

[0028] FIG10B depicts a cross-sectional view of the fluid injection device of FIG5 with the retinal penetrating element in an extended position;

[0029] FIG11A depicts a cross-sectional view of the distal portion of the fluid injection device of FIG5 with the retinal penetrating element in a retracted position;

[0030] FIG11B depicts a cross-sectional view of the distal portion of the fluid injection device of FIG5 with the retinal penetrating element in an extended position;

[0031] FIG12A depicts a cross-sectional view of the proximal portion of the fluid injection device of FIG5 with the retinal penetrating element in a retracted position;

[0032] FIG12B depicts a cross-sectional view of the proximal portion of the fluid injection device of FIG5 with the retinal penetrating element in an extended position;

[0033] FIG12C depicts a cross-sectional view of the proximal portion of the fluid injection device of FIG5 , showing the retinal penetrating element in an extended position, the first valve of the fluid supply assembly in an open state to supply the first fluid to the retinal penetrating element, and the second valve of the fluid supply assembly in a closed state;

[0034] FIG12D depicts a cross-sectional view of the proximal portion of the fluid injection device of FIG5 , showing the retinal penetrating element in an extended position, the first valve of the fluid supply assembly in a closed state, and the second valve of the fluid supply assembly in an open state to supply a second fluid to the retinal penetrating element;

[0035] FIG13 depicts an exploded perspective view of the fluid source assembly of FIG5;

[0036] FIG14 depicts an exploded perspective view of the pressure control delivery assembly of FIG5;

[0037] 15A depicts a top view of the fluid selection device of the pressure control delivery assembly of FIG. 5 , wherein a flow selector of the fluid selection device is in a first open state;

[0038] 15B depicts a top view of the fluid selection device of the pressure control delivery assembly of FIG. 5 , wherein the flow selector of the fluid selection device is in a second open state;

[0039] FIG16 depicts an exploded perspective view of another example of a system for delivering a therapeutic agent to the subretinal space, the system comprising a fluid injection device, a fluid source assembly, and a pressure controlled delivery assembly;

[0040] FIG17 depicts an exploded perspective view of the fluid injection apparatus of FIG16;

[0041] FIG18 depicts a perspective view of a portion of the actuation assembly of the fluid injection device of FIG16;

[0042] FIG19 depicts a cross-sectional view of the fluid injection device of FIG16;

[0043] FIG20 depicts an exploded perspective view of the fluid source assembly of FIG16;

[0044] FIG21 depicts a top view of the fluid source assembly of FIG16;

[0045] FIG22 depicts a cross-sectional view of the fluid source assembly of FIG16;

[0046] FIG23 depicts a rear view of the fluid source assembly of FIG16;

[0047] FIG. 24 depicts an exploded perspective view of the pressure controlled delivery assembly of FIG. 16 .

[0048] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology may be performed in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of the specification, depict several aspects of the technology and, together with the description, serve to explain the principles of the technology; however, it should be understood that the technology is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0049] The following description of certain 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 become apparent to those skilled in the art from the following description, which is intended to illustrate one of the best modes for implementing the present technology. As will be appreciated, the technology described herein can have other different and obvious aspects, all without departing from the present technology. Therefore, the drawings and descriptions should be considered to be illustrative rather than restrictive in nature.

[0050] It should also 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. Therefore, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from each other. In view of the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0051] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator grasping a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is closer to the surgeon or other operator, and the term "distal" refers to a position where an element is closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0052] I. Examples of Devices for Transretinal Delivery of Therapeutic Agents

[0053] 1-2B illustrate an example of a device (110) that can be used to deliver a bleb fluid (340) and a therapeutic agent (341) to the subretinal space via a single lumen in a single tip via a vitreous, retinal route. Figure 1 As shown, the device (110) of this example includes a pair of Luer connectors (195, 196), a fluid supply guide (192), supply tubes (190, 191) respectively fluidly connected to the Luer connectors (195, 196), a body (140), a slider (200) and a fluid delivery assembly (130). The Luer connectors (195, 196) can be connected to two different fluid sources, such as a guide bubble (340) fluid and a therapeutic fluid (341). The Luer connectors (195, 196) are respectively connected to pipelines (193, 194), which terminate at the fluid supply guide (192). Although conventional Luer connectors (195, 196) are used in this example, any other suitable type of connector may also be used.

[0054] The fluid supply guide (192) brings the pipelines (193, 194) together in a fixed parallel relationship. The supply tubes (190, 191) exit the fluid supply guide (192) and enter the body (140), as will be described in more detail below. It should be understood that the fluid supply guide (192) provides a dedicated path for fluid transfer from the pipeline (193) to the supply tube (190) and from the pipeline (194) to the supply tube (191). The fluid supply guide keeps the path associated with the pipeline (193) and the supply tube (190) isolated from the path associated with the pipeline (194) and the supply tube (191). The fluid source connected to the Luer connector (195, 196) can be pressurized manually (e.g., such as with a syringe) or automatically (e.g., with a pump). The operator may then select which fluid source to pressurize to selectively pump fluid (340, 341) to the corresponding supply tubes (190, 191).

[0055] The fluid delivery assembly (130) includes an outer cannula (120) and an inner cannula (131). The outer cannula (120) is fixed relative to the body (140). The outer cannula (120) is sized and configured to pass through a trocar port (318) inserted into the patient's eye (301). The inner cannula (131) can slide longitudinally relative to the outer cannula (120) and the body (140). Specifically, the inner cannula (131) is longitudinally driven by the slider (200).

[0056] As shown in FIGS. 2A-2B , the slider (200) is slidably connected to the body (140). The slider (200) is capable of translating from a proximal position, as shown in FIG. 2A , to a distal position, as shown in FIG. 2B . Translation of the slider (200) translates the inner cannula (131) relative to the body (140) and relative to the outer cannula (120). In some versions, the slider (200) is operable to slide the inner cannula (131) along a longitudinal distance of up to about 10 mm. Alternatively, any other suitable distance may be provided. The inner cannula (131) is in fluid communication with the two supply tubes (190, 191).

[0057] In the present example, the distal end of the inner cannula (131) is cut flat so that the distal edge of the inner cannula extends along a plane perpendicular to the longitudinal axis of the inner cannula (131). In other words, in the present example, the distal end of the inner cannula (131) is not sharp. However, as described below, despite the blunt configuration of the distal end of the inner cannula (131), the distal end of the inner cannula (131) is able to penetrate the retina (308) due to the smaller diameter of the inner cannula (131), the column strength of the material forming the inner cannula (131), and the fragility of the retina (308). In some other versions, the distal end of the inner cannula (131) is sharp or has some other configuration.

[0058] Thus, the inner cannula (131) is able to penetrate the retina (308) to deliver fluid from either supply tube (190, 191) to the subretinal space. An example of a method of using the device (110) in this manner is described in more detail below. Other suitable ways in which the device (110) can be modified and used will be apparent to those skilled in the art in light of the teachings herein. By way of example only, the device (110) can be configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,639,193. The patent, entitled "Therapeutic Agent Delivery Device Having a Converging Lumen," was issued on May 5, 2020, and the disclosure of which is incorporated herein by reference.

[0059] II. Examples of Methods for Transretinal Delivery of Therapeutic Agents

[0060] 3 through 4J illustrate a method of administering a therapeutic agent (341) ipsilaterally or transvitreally to a patient's subretinal space using the device (110).

[0061] As shown in FIG3 , the procedure begins with the operator securing tissue (e.g., eyelid) surrounding the patient's eye (301) using a speculum (312) and / or any other suitable instrument for securing. Although the securing is described herein with reference to tissue surrounding the eye (301), it should be understood that the eye (301) itself may remain free to move. Once the tissue surrounding the eye (301) is secured, an eye pendant light port (314) is inserted into the eye (301) to provide intraocular illumination while viewing the interior of the eye (301) through the pupil. In the present example, the eye pendant light port (314) is located in the lower inner quadrant. Additionally, a vitrectomy port (317) is inserted into the eye (301) to provide access for performing a standard three-port pars plana core vitrectomy. In the present example, the vitrectomy port (317) is located in the superior temporal quadrant. Moreover, a third port (318) is inserted into the eye (301) to provide access for a device to administer a therapeutic fluid (341) to the subretinal space of the eye (301). In the present example, the third port (318) is located in the superomedial quadrant. Various suitable forms that the ports (314, 317, 318) may take will be apparent to those skilled in the art in view of the teachings herein.

[0062] As shown in FIG. 4A , the eye pendant light port (314) is positioned to direct light into the interior of the eye (314) 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 an area of ​​the eye (301) to which the therapeutic agent (341) is targeted for delivery. An optical fiber (315) is inserted into the port (314) to provide illumination. Optionally, a microscope may be utilized to visually inspect the eye to confirm the proper positioning of the eye pendant light port (314) relative to the target site. Although FIG. 4A illustrates a particular positioning of the eye pendant light port (314), it should be understood that the eye pendant light port (314) may have any other positioning apparent to one skilled in the art in view of the teachings herein. Additionally, a conventional vitrectomy instrument (400) is inserted through the vitrectomy port (317) to perform a conventional three-port pars plana core vitrectomy procedure. After the conventional three-port pars plana core vitrectomy procedure is completed, the vitrectomy instrument (400) is removed.

[0063] After or before a conventional three-port pars plana core vitrectomy procedure is completed, the apparatus (110) may be prepared for administering a therapeutic fluid (341) subretinaally. By way of example only, preparation of the apparatus (110) may include coupling a luer connector (195) to a source of a therapeutic fluid (341) and coupling a luer connector (196) to a source of a guiding bubble fluid (340). Next, the fluid source may be pressurized to irrigate a fluid delivery component leading to and including the lumen of the inner cannula (131) until a drop of guiding bubble fluid (340) or therapeutic fluid (341) exits the distal end of the inner cannula (131). In some cases, the source of the therapeutic fluid (341) is pressurized first, and then the source of the guiding bubble fluid (340) is pressurized. In some other cases, the source of the guiding bubble fluid (340) is pressurized first, and then the source of the therapeutic fluid (341) is pressurized. In some other cases, the two fluid sources are pressurized substantially simultaneously. It should also be understood that in some cases, an air gap can be provided between the guide bubble (340) and the therapeutic fluid (341) to prevent the therapeutic fluid (341) from mixing with the guide bubble (340). Various suitable ways in which the device (110) can be perfused with the guide bubble fluid (340), the therapeutic fluid (341), and / or an intentional air gap will be apparent to those skilled in the art in view of the teachings herein.

[0064] After the device (110) has been primed, the outer cannula (120) is inserted into the third port (318), as shown. Figure 4B When the outer cannula (120) is inserted into the third port (318), the slider (200) is in the proximal position, as shown in FIG2A, thereby ensuring that the distal end of the inner cannula (131) is located inside the outer cannula (120). The outer cannula (120) is inserted to a point where the distal end of the outer cannula (120) is adjacent to the inside of the retina (308).

[0065] Once the distal end of the outer cannula (120) is adjacent to the interior of the retina (308), the slider (200) slides distally, exposing the distal end of the inner cannula (131) to the distal end of the fixed outer cannula (120). As a result, the inner cannula (131) pierces the retina (308) to define a subretinal entry point (339), as shown in FIG4C.

[0066] Once the distal end of the inner cannula (131) is located at a first position in the subretinal space via the subretinal entry point (339), the fluid source of the guide bubble fluid (430) is pressurized. The pressurization drives the fluid through the lumen of the inner cannula (131) to form a guide bubble (340) in the subretinal space between the retina (308) and the choroid (306), as shown in FIG4D.

[0067] Once the guide bubble (340) is formed at the first position in the subretinal space, the inner cannula (131) is further advanced distally by actuation of the slider (200), so that the inner cannula (131) is advanced in the inferior direction along the coronal plane and in the posterior direction along the sagittal plane, as shown in Figures 4E to 4F. Specifically, the inner cannula (131) first travels between the guide bubble (340) and the choroid (306) (Figure 4E), and then passes through the guide bubble (340) into the space between the retina (308) and the choroid (306) (Figure 4F). This advancement of the inner cannula (131) thus defines a passage (342) between the retina (308) and the choroid (306).

[0068] Once the inner cannula (131) reaches the second location in the subretinal space at the end of the passageway (342), the therapeutic agent (341) is injected into the subretinal area by pressurizing a fluid source of the therapeutic agent (341) so that the therapeutic agent (341) protrudes distally through the lumen of the inner cannula (131), as shown in Figure 4F.

[0069] Once the appropriate amount of therapeutic fluid (341) is delivered to the second location, the slider (200) is retracted proximally, thereby retracting the inner cannula (131) to the first position, as shown in FIG4G. When the inner cannula (131) is retracted from the passageway (342), the guide bubble fluid (340) can be pressurized again to release the guide bubble fluid (340) within the passageway (342) to help seal the therapeutic fluid (341) at the second location.

[0070] Once the inner cannula (131) has been retracted from the passageway (342), as shown in FIG4G, negative pressure may be induced through either supply tube (190, 191) within the inner cannula (131) to draw out the suction guide bubble (340), as shown in FIG4H. Alternatively, negative pressure may be induced through other means known in the art, such as using a separate flexible tip inserter (MedOne) to draw out the suction guide bubble (340). The separate flexible tip inserter or other conventional instrument may be inserted after the instrument (110) is removed from the eye (301). In addition to or in lieu of the suction guide bubble (340), air or other fluids may be used to effectively pack the bubble (340) in the subretinal space.

[0071] After the guide bubble (340) has been aspirated or tamponade, the instrument (110) is removed from the third port (318), as shown in FIG4I. Thereafter, as shown in FIG4J, the laser retinal fixation tool (500) is inserted into the third port (318) and seals the subretinal entry point (339). Alternatively, any other suitable instrument or technique may be used to seal the subretinal entry point (339).

[0072] It should be understood from the foregoing that the device (110) can be used to deliver two different types of fluids (e.g., a guide bubble fluid (340) and a therapeutic agent (341)) to the subretinal space without withdrawing the inner cannula (131) from the subretinal space between the actions of delivering the first fluid (e.g., the guide bubble (340) fluid) and the second fluid (e.g., the therapeutic agent (341)).

[0073] III. Examples of Subvitreous Injection Systems

[0074] In some circumstances, it may be desirable to provide an outer cannula (120) with a tapered distal tip, such as to assist in inserting the outer cannula (120) into the trocar port (318) and / or to assist in maintaining the inner cannula (131) centered relative to the outer cannula (120) during translation of the inner cannula (131) relative to the outer cannula (120) (e.g., by contacting or otherwise guiding the inner cannula (131)). It should be appreciated that maintaining the inner cannula (131) centered relative to the outer cannula (120) may allow the inner cannula (131) to have a relatively high stiffness, particularly when the inner cannula (131) is only slightly extended beyond the outer cannula (120). At the same time, as the inner cannula (131) is further extended beyond the outer cannula (120), it still allows the inner cannula (131) to have sufficient flexibility to travel along the passageway (342). This relatively high stiffness can facilitate controlled penetration of the retina (308) by the inner cannula (131) as it initially extends out of the outer cannula (120) to define a subretinal entry point (339) at a desired location and / or controlled advancement of the inner cannula (131) after such penetration of the retina (308), such as between a guide bubble (340) and the choroid (306).

[0075] Additionally or alternatively, it may be desirable to mount a fluid source coupled to a luer connector (195, 196) in a manner that limits movement of the fluid source relative to the instrument (110). For example, it may be desirable to mount the fluid source in a manner that prevents unintentional movement of the fluid source in a direction away from the instrument (110), which may cause the fluid source to pull the instrument (110) via the supply tubes (190, 191), thereby allowing precise manipulation of the instrument (110). Additionally or alternatively, it may be desirable to provide a fluid selection device that is capable of quickly switching between pumping fluids (340, 341) to corresponding supply tubes (190, 191), and / or remotely positioning the fluid selection device relative to the fluid source itself.

[0076] Each example of the system (1000, 2000) described below can function in this manner and can be used to deliver alveolar fluid (340) and therapeutic agents (341) to the subretinal space via a transvitreal, transretinal approach.

[0077] A. Example 1 of the subretinal injection system

[0078] FIG5 illustrates an example of a system (1000) including a fluid injection device (1110), a fluid source assembly (1210), and a pressure-controlled delivery assembly (1310) for delivering one or more fluids during surgery to treat the eye, such as subretinal delivery of the therapeutic agent (341) described above.

[0079] 6 to 12D, with continued reference to FIG. 5, the fluid injection device (1110) can be similar to the device (110) described above, except as otherwise described below. In this regard, the fluid injection device (1110) of this example includes a handle assembly (1112), a fluid supply assembly (1114), a fluid delivery assembly (1116), and an actuation assembly (1118).

[0080] The handle assembly (1112) of this example includes a rigid handle body (1120), a cannula hub 1121, and a strain relief (1122). The handle body (1120) is sized and configured to be grasped and operated by a single hand (e.g., left or right hand) of an operator, such as by a power grip, a pencil grip, or any other suitable type of grip. In the example shown, the handle body (1120) is formed by a first shell (e.g., half) (1120a, 1120b), and the first shell and the second shell are fixedly connected to each other along the longitudinal centerline of the handle body (1120) via corresponding pairs of engagement features (e.g., interlocking pawls and notches), so that the shells (1120a, 1120b) together define the handle body (1120). The housings (1120a, 1120b) may each be manufactured by 3D printing, injection molding, investment casting, machining, and / or any other suitable manufacturing technique, and subsequently assembled with one another to form the handle body (1120). It should be understood that the handle body (1120) may be formed in any other suitable manner. For example, the housings (1120a, 1120b) may be integrally formed with one another as a unitary (e.g., monolithic) piece to define the handle body (1120), such that corresponding pairs of engagement features may be omitted.

[0081] As shown, the handle body (1120) defines an internal cavity (1124) that is configured to at least partially accommodate various components of the fluid supply assembly (1114), the fluid delivery assembly (1116), and the actuation assembly (1118). In this regard, the handle body (1120) of the present example further includes a proximal hole (1125) configured to accommodate a portion of the fluid supply assembly (1114) and a distal hole (1126) configured to accommodate a portion of the fluid delivery assembly (1116), such that the fluid supply assembly (1114) can extend out of the internal cavity (1124) via the proximal hole (1125), and the fluid delivery assembly (1116) can extend out of the internal cavity (1124) via the distal hole (1126). In the example shown, a pair of internal bridges 1127 extend transversely across the internal cavity (1124) and include corresponding central apertures 1128 configured to receive a portion of the fluid delivery assembly (1116), such that the bridges 1127 can provide support to the fluid delivery assembly (1116) within the internal cavity (1124). In the example shown, a cannula hub (1121) is fixedly coupled to the handle body (1120) within the internal cavity (1124) and includes a central aperture (1129) configured to receive a portion of the fluid delivery assembly (1116), such that the cannula hub (1121) can provide support to the fluid delivery assembly (1116) within the internal cavity (1124).

[0082] The handle body (1120) of the present example further includes a pair of laterally opposed pivot pins (1130) (one shown) extending laterally inwardly and configured to be pivotally received by a corresponding portion of the actuation assembly (1118), and an upper slot (1131) generally located above the pivot pins (1130) and configured to expose a corresponding portion of the actuation assembly (1118) to the exterior of the handle body (1120), as described in more detail below. In the example shown, the handle body (1120) further includes a plurality (e.g., four) longitudinal channels (1132) (two shown) configured to slidably receive a corresponding portion of the actuation assembly (1118).

[0083] As shown, strain relief (1122) is coupled to the proximal end of handle body (1120) and defines a channel (1133) in communication with proximal aperture (1125) to direct a proximal portion of fluid supply assembly (1114) proximally and / or laterally away from interior cavity (1124). In some versions, strain relief (1122) may include a flexible material.

[0084] The fluid delivery assembly (1116) of the present example includes an outer cannula (1134) and an inner cannula (1135). Unless otherwise described below, the outer cannula (1134) is similar to the outer cannula (120) described above, and, unless otherwise described below, the inner cannula (1135) is similar to the inner cannula (131) described above. In this regard, the outer and inner cannulas (1134, 1135) can be used with the remainder of the instrument (1110) in a manner similar to the outer and inner cannulas (120, 131) to perform the same process described above in conjunction with Figures 4A to 4J. The outer cannula (1134) is fixed relative to the handle body (1120) and is sized and configured to enable it to pass through a trocar port (318) inserted into the patient's eye (301). The inner cannula (1135) can slide longitudinally relative to the outer cannula (1134) and the handle body (1120) via the actuation assembly (1118), which will be described in more detail below. The outer cannula (1134) can be substantially rigid, while the inner cannula (1135) can be flexible. In some versions, the outer cannula (1134) can include a metallic material, such as surgical stainless steel. Additionally or alternatively, the inner cannula (1135) can include a polymer material, such as polyimide. In view of the teachings herein, those skilled in the art will readily appreciate other suitable materials that can be used to form the outer cannula (1134) and / or the inner cannula (1135).

[0085] In the example shown, the outer cannula (1134) extends between an open proximal end (1136) and an open distal end (1137); and defines an outer lumen 1138 extending therebetween for slidably receiving the inner cannula (1135) and a portion of the actuation assembly (1118). As shown in FIGS. 11A to 11B , the outer cannula (1134) includes a generally cylindrical proximal portion (1140) extending distally from the proximal end (1136) and a generally frustoconical distal portion (1141) tapering radially inwardly from the proximal portion (1140) to the distal end (1137), such that the distal portion (1141) may have at least one cross-sectional dimension (e.g., diameter) that is smaller than the proximal portion (1140), and thus may be configured to help guide the outer cannula (1134) into the trocar port (318). For example, distal portion ( 1141 ) may be sized and configured to be funneled into trocar port ( 318 ), thereby guiding proximal portion ( 1140 ) into trocar port ( 318 ).

[0086] Additionally or alternatively, the tapered configuration of the distal portion (1141) can cause the outer lumen 1138 to converge at the distal portion (1141) such that the distal end (1137) defines a smaller opening than the opening defined by the proximal end (1136). The relatively small opening defined by the distal end (1137) can help maintain the centering of the inner cannula (1135) relative to the outer cannula (1134) (e.g., ensuring a coaxial relationship between the inner cannula (1135) and the outer cannula (1134) during translation of the inner cannula (1135) relative to the outer cannula (1134)), such as by contacting or otherwise guiding the inner cannula (1135) out through the distal end (1137). This centering of inner cannula (1135) relative to outer cannula (1134) may allow inner cannula (1135) to have a relatively high stiffness, at least when inner cannula (1135) extends only slightly beyond outer cannula (1134), such as during puncturing of the retina (308).

[0087] Although the distal portion (1141) of the present example tapers radially inward from the proximal portion (1140) to the distal end (1137), the distal portion (1141) may alternatively be curved radially inward from the proximal portion (1140) to the distal end (1137). Although the proximal and distal portions (1140, 1141) of the present example are integrally formed as a single (e.g., unitary) piece to define the outer cannula (1134), the proximal and distal portions (1140, 1141) may alternatively be formed as distinct components from one another and coupled to one another to define the outer cannula (1134).

[0088] Any one or more of the distal aperture (1126) and / or the central aperture (1128, 1129) of the handle assembly (1112) may be configured to receive the proximal portion (1140) of the outer cannula (1134) to securely secure the outer cannula (1134) to the handle body (1120). For example, one or more of the distal aperture (1126) and / or the central aperture (1128, 1129) may be configured to frictionally engage the generally cylindrical outer surface of the proximal portion (1140) of the outer cannula (1134) to securely secure the outer cannula (1134) to the handle body (1120). As shown, a fixed cannula support tube (1142) is secured to the proximal portion (1140) of the outer cannula (1134) and is at least partially disposed within a portion of the actuation assembly (1118) to further support the outer cannula (1134).

[0089] In the example shown, the inner cannula (1135) extends between an open proximal end (1143) and an open distal end (1144); and defines an inner lumen (1145) extending therebetween to direct fluid therethrough. As shown in FIGS. 11A-11B , the distal end (1144) of the inner cannula (1135) is beveled such that the distal end (1144) is oriented at an angle relative to the longitudinal axis of the inner cannula (1135). The angle at which the distal end (1144) is oriented relative to the longitudinal axis of the inner cannula (1135) may be, for example, about 45 degrees. In this manner, when the lumen (1145) is used to pierce the retina (308) to define a subretinal entry point (339) and / or form a guide bubble (340) within the subretinal space, the distal end (1144) of the inner cannula (1135) can be configured to be oriented generally parallel to the retinal pigment epithelium (RPE) of the eye (301). This can reduce the risk of the distal end (1144) piercing or otherwise causing undesirable trauma to the RPE and / or improve the formation of the guide bubble (340).

[0090] The actuation assembly (1118) of the present example includes a pivotable roller (1150), a translatable cannula slide plate (1151), and a translatable cannula support tube (1152) configured to cooperate with each other to drive the inner cannula (1135) to translate relative to the outer cannula (1134). In the example shown, the roller (1150) is pivotally coupled to the handle body (1120) and includes a generally arcuate gripping portion (1153) and a pair of laterally opposed arms (1154) extending generally downwardly from the gripping portion (1153). The roller (1150) of the present example further includes a pair of pivot holes (1155) (one is shown), each pivot hole extending laterally outward from a lower portion of a corresponding arm (1154) and configured to pivotally receive a corresponding pivot pin (1130) of the handle body (1120) for pivotally coupling the roller (1150) to the handle body (1120), such that the roller (1150) can be pivoted about a pivot axis defined by the pivot pin (1130) and the pivot hole (1155) between an unactuated state ( FIGS. 9A , 10A , and 12A ) and at least one actuated state (such as a fully actuated state ( FIG. 11A ). Fig. 9B , Figure 10B and Fig. 12B). In this regard, the gripping portion (1153) can be at least partially exposed to the exterior of the handle body (1120) via the upper slot (1131) to enable an operator to access and manipulate the gripping portion (1153) between the unactuated and fully actuated states, for example, with the operator's thumb. In some versions, the handle body (1120) can include one or more stop elements configured to selectively engage a corresponding portion of the roller (1150) when the roller (1150) is pivoted to the unactuated and / or fully actuated states to prevent the roller (1150) from further pivoting beyond the unactuated and / or fully actuated states.

[0091] In the illustrated example, the roller (1150) further includes a pair of parallel flanges (1156) extending generally downwardly from the gripping portion (1153) between the arms (1154) and having opposing, generally flat cam surfaces (1157) spaced apart from one another to define a receptacle (1158) configured to receive a portion of the cannula slide (1151).

[0092] In this regard, the cannula slide (1151) of the present example is translationally coupled to the handle body (1120) and includes a slide housing (1160) and a connecting member (1162). As shown in FIG8, the slide housing (1160) includes a roller (1163) and a yoke (1164), the yoke extending distally from the roller (1163) and having a generally spherical distal hook (1165) extending generally upward to provide accommodation within the socket (1158) of the roller (1150). In the illustrated example, the coupling (1165) has a generally C-shaped cam surface (1166) configured to cammingly engage one or both planar cam surfaces (1157) of the roller (1150) to convert pivoting of the roller (1150) to translate the cannula sled (1151) such that the cannula sled (1151) can longitudinally translate between a proximal position (Figures 10A to 12A) and a distal position (Figures 10B to 12B) in response to pivoting of the roller (1150) between an unactuated state and a fully actuated state. The roller (1163) of the present example includes a plurality (e.g., four) longitudinal guides (1167) (two are shown) that are configured to be slidably received within corresponding longitudinal channels (1132) of the handle body (1120) such that interaction between the channels (1132) and the guides (1167) can guide the cannula slide (1151) to longitudinally translate (1150) between a proximal position and a distal position during pivoting of the roller between an unactuated and a fully actuated state.

[0093] As shown, the yoke (1164) of the slide housing (1160) further includes a central hole (1168) configured to slidably receive the cannula support tube (1142) so that the outer cannula (1134) of the fluid delivery assembly (1116) can be supported by the cannula slide (1151) via the cannula support tube (1142) without interfering with the longitudinal translation of the cannula slide (1151). In this regard, the central hole (1168) can have an inner cross-sectional dimension (e.g., diameter) that is at least slightly larger than the outer cross-sectional dimension (e.g., diameter) of the cannula support tube (1142). In the example shown, the proximal end (1136) of the outer cannula (1134) is disposed within the central hole (1168). The roller (1163) of the slide housing (1160) further includes a chamber (1169) disposed proximally of the central aperture (1168) and configured to securely retain the connection member (1162). In this regard, a longitudinal alignment slot (1170) extends distally from the proximal end of the roller (1163) through the side wall of the roller (1163) to help facilitate proper alignment of the connection member (1162) relative to the slide housing (1160) when the connection member (1162) is loaded into the chamber (1169) of the roller (1163).

[0094] The connecting member (1162) of this example includes a roller (1171) and a tube clamp (1172) extending distally from the roller (1171). As shown, the tube clamp (1172) of the connecting member (1162) includes a central generally C-shaped recess (1173) configured to securely accommodate the cannula support tube (1152) to fix the cannula support tube (1152) to prevent it from moving relative to the connecting member (1162) so that the cannula support tube (1152) can be longitudinally translated with the cannula slide (1151). In this regard, the central recess (1173) has an inner cross-sectional dimension (e.g., diameter) that is substantially equal to the outer cross-sectional dimension (e.g., diameter) of the cannula support tube (1152) to provide a friction fit therebetween. In some versions, a side cover (not shown) may be secured to a side of connection member (1162) to capture cannula support tube (1152) within central recess (1173). For example, such a cover may include a generally C-shaped central recess that may align with central recess (1173) to collectively define a central aperture configured to securely receive cannula support tube (1152).

[0095] In the example shown, the cannula support tube (1152) is slidably received within the outer lumen 1138 of the outer cannula (1134); and is configured to securely receive the inner cannula (1135) to secure the inner cannula (1135) to prevent it from moving relative to the cannula support tube (1152) (and therefore relative to the connecting member (1162)), so that the inner cannula (1135) can translate longitudinally with the cannula support tube (1152) and the cannula slide (1151). In the example shown, the proximal end (1136) of the outer cannula (1134) is spaced a sufficient distance from the tube clamp (1172) to allow the cannula slide (1151) to translate between the proximal position and the distal position without the risk of collision between the tube clamp (1172) and the proximal end (1136) of the outer cannula (1134). The roller (1171) of the connecting member (1162) includes a radially outwardly extending alignment protrusion (1174) configured to be slidably received in the alignment slot (1170) of the slide housing (1160) for maintaining the connecting member (1162) in proper alignment relative to the slide housing (1160). The roller (1171) also includes a chamber (1175) disposed proximal to the central recess (1173) and configured to securely retain at least a portion of the fluid supply assembly (1114). In this regard, the roller (1171) includes a pair of laterally opposed holes (1176) (one is shown) configured to selectively receive a retaining pin (1177) for retaining various components of the fluid supply assembly (1114) within the chamber (1175).

[0096] The fluid supply assembly (1114) of the present example includes first and second Luer connectors (1180a, 1180b), first and second fluid supply tubes (1181a, 1181b), a fluid supply connector (1182), first and second self-actuated check valves (1183a, 1183b), and a valve retainer (1184). In the example shown, each fluid supply tube (1181a, 1181b) extends between an open proximal end (not shown) and an open distal end (1186a, 1186b), and defines an inner cavity (1187a, 1187b) extending therebetween for directing fluid therethrough. The open proximal end of each fluid supply tube (1181a, 1181b) is fluidly coupled to a corresponding Luer fitting (1180a, 1180b), and each open distal end (1186a, 1186b) is fluidly coupled to a fluid supply connector (1182), as described in more detail below. In the illustrated example, the fluid supply tubes (1181a, 1181b) each extend through the proximal aperture (1125) of the handle body (1120) and the passageway (1133) of the strain relief (1122) such that the open distal ends (1186a, 1186b) are located within the interior cavity (1124) of the handle body (1120) for coupling to the fluid supply connector (1182), while the open proximal ends of the fluid supply tubes (1181a, 1181b) are located outside of the handle body (1120) for coupling to corresponding Luer connectors (1180a, 1180b). The fluid supply tubes (1181a, 1181b) can each be configured to slide through the proximal aperture (1125) of the handle body (1120) and the channel (1133) of the strain relief (1122) to accommodate translation of the cannula sled (1151) relative to the handle body (1120). For example, distal translation of the cannula sled (1151) relative to the handle body (1120) can slightly pull the distal ends (1186a, 1186b) of the fluid supply tubes (1181a, 1181b) apart distally, as shown in FIGS. 10A-10B. In some versions, supply tubes (1181a, 1181b) may be provided with sufficient slack within lumen (1124) of handle body (1120) such that supply tubes (1181a, 1181b) do not have to slide through proximal aperture (1125) during translation of cannula sled (1151) relative to handle body (1120).

[0097] The Luer connectors (1180a, 1180b) can be connected to two different fluid sources, such as a source of guiding bubble fluid (340) and a source of therapeutic fluid (341), which can be selectively pressurized to selectively pump fluids (340, 341) to corresponding supply tubes (1181a, 1181b), as described in more detail below. Although conventional Luer connectors (1180a, 1180b) are used in this example, any other suitable type of connector may be used.

[0098] As shown, the fluid supply connector (1182) and the valve retainer (1184) are each securely retained within the chamber (1175) of the connecting member (1162) of the actuating assembly (1118). More specifically, the retaining pin (1177) (FIG. 6) captures the fluid supply connector (1182) and the valve retainer (1184) within the chamber (1175). The fluid supply connector (1182) of the present example includes first and second proximal fluid supply channels (1188a, 1188b) that are fluidically isolated from each other and are configured to be fluidically coupled to the open distal ends (1186a, 1186b) of the first and second fluid supply tubes (1181a, 1181b), respectively. In the example shown, the fluid supply connector (1182) includes first and second generally annular valve seats (1189a, 1189b) defined around the open distal ends of the respective fluid supply passages (1188a, 1188b) and angled relative to each other to define a "V" shape, the purpose of which is described below. As shown, a generally oblong groove (1190) extends radially inwardly from the radially outer surface of the fluid supply connector (1182), and a proximal gasket in the form of a generally oblong O-ring (1191) is disposed within the groove (1190) for providing a fluid-tight seal between the fluid supply connector (1182) and one side of the chamber (1175).

[0099] The valve retainer (1184) of the present example includes a single distal fluid supply channel (1192) that is fluidically coupled to the lumen (1145) of the inner cannula (1135) and is configured to selectively fluidically couple to first and second proximal fluid supply channels (1188a, 1188b) of the fluid supply connector (1182). In this regard, the valve retainer (1184) further includes first and second generally dome-shaped recesses (1193a, 1193b) that are configured to face the first and second valve seats (1189a, 1189b), respectively, to define first and second fluid channels (1194a, 1194b) therebetween. As shown, a generally circular groove (1195) extends proximally from the distal surface of the valve retainer (1184), and a distal gasket in the form of a generally circular O-ring (1196) is disposed within the groove (1195) for providing a fluid-tight seal between the valve retainer (1184) and the distal end of the chamber (1175).

[0100] As shown, each fluid gateway (1194a, 1194b) is configured to selectively fluidically couple a corresponding proximal fluid supply channel (1188a, 1188b) to a distal fluid supply channel (1192) to selectively direct fluid from the corresponding proximal fluid supply channel (1188a, 1188b) to the distal fluid supply channel (1192) through the corresponding fluid gateway (1194a, 1194b). In this regard, a corresponding portion of each valve (1183a, 1183b) is at least partially disposed within each fluid passage (1194a, 1194b) for selectively placing the corresponding proximal fluid supply channel (1188a, 1188b) in fluid communication or not in fluid communication with the distal fluid supply channel (1192). To this end, the valve retainer (1184) includes first and second valve retaining grooves (1197a, 1197b). Each valve (1183a, 1183b) includes a generally frustoconical stem (1198a, 1198b) securely received within a corresponding valve retaining groove (1197a, 1197b) and a generally disc-shaped flexible membrane (1199a, 1199b). In some versions, the fluid supply connector (1182) can capture the stem (1198a, 1198b) within the corresponding valve retaining groove (1197a, 1197b). Each disc-shaped membrane (1199a, 1199b) is flexibly coupled to the corresponding stem (1198a, 1198b) (e.g., via a corresponding living hinge) so that each membrane (1199a, 1199b) can bend between a corresponding open state and a closed state.

[0101] More specifically, the membrane (1199a) of the first valve (1183a) is bendable between a closed state (FIGS. 12A, 12B, and 12D) and an open state (FIG. 12C). In the closed state, the membrane (1199a) sealingly engages the first valve seat (1189a) of the fluid supply connector (1182) to prevent fluid from flowing from the first proximal fluid supply channel (1188a) through the first fluid gateway (1194a) to the distal fluid supply channel (1192). In the open state, the membrane (1199a) disengages from the first valve seat (1189a) of the fluid supply connector (1182) to allow fluid to flow from the first proximal fluid supply channel (1188a) through the first fluid gateway (1194a) to the distal fluid supply channel (1192). Likewise, the membrane (1199b) of the second valve (1183b) is bendable between a closed state (FIGS. 12A to 12C) and an open state (FIG. 12D). In the closed state, the membrane (1199b) sealingly engages the second valve seat (1189b) of the fluid supply connector (1182) to prevent fluid from flowing from the second proximal fluid supply channel (1188b) through the second fluid gateway 1194b to the distal fluid supply channel (1192). In the open state, the membrane (1199b) disengages from the second valve seat (1189b) of the fluid supply connector (1182) to allow fluid to flow from the second proximal fluid supply channel (1188b) through the second fluid gateway 1194b to the distal fluid supply channel (1192).

[0102] Each membrane (1199a, 1199b) of the present example is elastically biased to present a corresponding closed state, and is configured to bend toward a corresponding open state in response to applying a threshold downstream directional force to the corresponding membrane (1199a, 1199b). This may be caused by the presence of a threshold fluid pressure in the corresponding proximal fluid supply channel (1188a, 1188b). For example, each membrane (1199a, 1199b) can be configured to bend toward a corresponding open state immediately in response to the fluid pressure in the corresponding proximal fluid supply channel (1188a, 1188b) reaching a threshold fluid pressure to allow fluid to flow in a downstream direction therein, and can be configured to elastically return to a corresponding closed state immediately in response to the fluid pressure in the corresponding proximal fluid supply channel (1188a, 1188b) dropping below to prevent fluid from flowing back in an upstream direction. In this regard, each valve (1183a, 1183b) may include an elastomeric material, such as silicone. In some versions, each valve (1183a, 1183b) is configured as a Belleville valve, such as the type sold by Minivalve International of Oldenzaal, The Netherlands, or from any other suitable source. Additionally or alternatively, each valve (1183a, 1183b) can be configured and operated in accordance with one or more teachings of EP 1953432, entitled "Fluid Control Valve," issued April 12, 2017.

[0103] As shown in FIG. 12C , when the membrane ( 1199a ) of the first valve ( 1183a ) is in a corresponding open state and the membrane ( 1199b ) of the second valve ( 1183b ) is in a corresponding closed state, the bubble fluid ( 340 ) can flow from the first Luer connector ( 1180a ) through the first lumen ( 1187a ) of the first fluid supply tube ( 1181a ), through the fluid supply connector ( 1188a ) of the first proximal fluid supply channel fluid supply connector ( 1182 ), through the first fluid channel ( 1194a ), through the distal fluid supply channel ( 1192 ) of the valve holder ( 1184 ), and into the lumen ( 1145 ) of the inner cannula ( 1135 ) for delivery at the angled distal end ( 1144 ). Due to the closure of membrane (1199b) of second valve (1183b), therapeutic fluid (341) may remain substantially isolated from bubble fluid (340) within device (1110) during this delivery of bubble fluid (340).

[0104] As shown in FIG. 12D , when the membrane ( 1199b ) of the second valve ( 1183b ) is in a corresponding open state and the membrane ( 1199a ) of the first valve ( 1183a ) is in a corresponding closed state, the therapeutic fluid ( 341 ) can flow from the second Luer connector ( 1180b ) through the second lumen ( 1187b ) of the second fluid supply tube ( 1181b ), through the second proximal fluid supply channel ( 1188b ) from the second fluid channel ( 1194b ) of the fluid supply connector ( 1182 ), through the distal fluid supply channel ( 1192 ) of the valve holder ( 1184 ) and into the lumen ( 1145 ) of the inner cannula ( 1135 ) for delivery at the inclined distal end ( 1144 ). Due to the closure of membrane (1199a) of first valve (1183a), bubble fluid (340) may remain substantially isolated from therapeutic fluid (341) within device (1110) during this delivery of therapeutic fluid (341).

[0105] It should be appreciated that the proximal O-ring (1191) may help prevent fluid flowing through either fluid supply channel (1194a, 1194b) from leaking proximally out of the chamber (1175) of the connecting member (1162), and the distal O-ring (1196) may help prevent fluid flowing between the distal fluid supply channel (1192) and the lumen (1145) of the inner cannula (1135) from leaking toward the sides of the chamber (1175) of the connecting member (1162).

[0106] Although Belle valves (1183a, 1183b) are used in the present example, any other suitable type of valve, such as an umbrella valve, may be used. In view of the teachings herein, other suitable ways in which valves may be incorporated into the apparatus (1100) and / or system (1000) will be apparent to those skilled in the art. For example, the apparatus (1100) may include an integral valve assembly that is configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,226,379. The patent, entitled "Methods and Apparatus for Subretinal Administration of Therapeutic Agents," was issued on March 12, 2019, and the disclosure of which is incorporated herein by reference.

[0107] Referring now to FIG. 13 , the fluid source assembly (1210) of the present example includes a first fluid source and a second fluid source (1212a, 1212b) in the form of a syringe, a syringe holder (1214), a holder base (1216), and a wearable component in the form of a sterile wristband 1218. As shown, each syringe (1212a, 1212b) includes a barrel (1220a, 1220b) having a distal end 1222a, 1222b, a proximal end (1224a, 1224b), and an inner cavity (not shown) extending therebetween. Each distal end (1222a, 1222b) includes a first dispensing opening (1226a, 1226b) and a threaded portion (1228a, 1228b) that enables the corresponding syringe (1212a, 1212b) to be coupled to a needle, tube, or the like. In some versions, each threaded portion (1228a, 1228b) includes a conventional Luer connector. In the illustrated example, the threaded portions (1228a, 1228b) are configured to threadably engage first and second Luer connectors (1180a, 1180b), respectively, for fluidly coupling the respective lumens of the syringes (1212a, 1212b) with the respective lumens (1187a, 1187b) of the supply tubes (1181a, 1181b). In this regard, the lumen of the first syringe 1220a contains a bubble fluid 340, while the lumen of the second syringe 1220b contains a therapeutic fluid (341). Each proximal end (1224a, 1224b) includes a second opening (not shown) configured to accommodate a corresponding plunger 1232a, 1232b). In some versions, the lumen of each syringe (1212a, 1212b) includes a first portion configured to accommodate a corresponding piston (1232a, 1232b), and a second portion of reduced cross-sectional size at the corresponding proximal end (1224a, 1224b). Each piston (1232a, 1232b) can be selectively advanced and retracted by fluidly coupling the lumen of the corresponding syringe (1212a, 1212b) to a source of pressurized air, as discussed in further detail below.

[0108] The proximal end (1224a, 1224b) of each syringe barrel (1220a, 1220b) includes a flange (1234a, 1234b) that extends radially outward relative to the longitudinal axis of the corresponding syringe (1212a, 1212b) and can be used as a finger grip, for example, when a user holds the corresponding syringe (1212a, 1212b). By way of example only, each syringe (1212a, 1212b) can be configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,258,502. The patent is entitled "Therapeutic Agent Delivery Device" and was issued on April 16, 2019, the disclosure of which is incorporated herein by reference.

[0109] The syringe holder (1214) of the present example includes a holder body (1240) having a pair of parallel longitudinal channels (1242) (one shown) configured to selectively retain a corresponding syringe barrel (1220a, 1220b) for selectively securing a syringe (1212a, 1212b) to the syringe holder (1214). In this regard, a pair of detents 1244 (one shown) each partially extend laterally outwardly over the corresponding channel (1242) to assist in selectively retaining the corresponding syringe barrel (1220a, 1220b) within the corresponding channel (1242), such as by providing a snap-fit ​​engagement with the corresponding syringe barrel (1220a, 1220b).

[0110] In the example shown, a pair of collars (1250a, 1250b) are located at the proximal end of the support body (1240) and aligned with the corresponding channels (1242). The collars (1250a, 1250b) enable the corresponding syringes (1212a, 1212b) to be coupled to a system having one or more power components, as described in more detail below. Each collar (1250a, 1250b) can be used to secure a corresponding portion of the pressure control delivery assembly (1310) (e.g., a syringe adapter (1318a, 1318b) described below) to the proximal end (1224a, 1224b) of the syringe (1212a, 1212b) and thereby prevent these portions of the pressure control delivery assembly (1310) from moving relative to the respective syringe (1212a, 1212b). Each collar (1250a, 1250b) can be configured to maintain these portions of the pressure control delivery assembly (1310) secured to the respective syringe (1212a, 1212b) even when a pressurized medium is delivered to either syringe (1212a, 1212b) at a pressure between about 20 psi and about 40 psi. Each collar (1250a, 1250b) of the present example includes a U The invention relates to a generally U-shaped body defined by a plurality of walls (1252a, 1252b), a first flange (1254a, 1254b) extending perpendicularly from the walls (1252a, 1252b) and an opposing second flange (1256a, 1256b) extending perpendicularly from the walls (1252a, 1252b) to define a U-shaped cavity sized and configured to receive at least a portion of the flange (1234a, 1234b) of a corresponding syringe (1212a, 1212b) and / or a corresponding portion of a pressure control delivery assembly (1310) (e.g., a corresponding flange (2370a, 2370b) as described below). By way of example only, each collar (1250a, 1250b) may be configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,258,502. The patent is entitled "Therapeutic Agent Delivery Device" and was filed on April 16, 2019. , the disclosure of which is incorporated herein by reference.

[0111] As shown, a grip tab (1258) extends upwardly from the distal end of the support body (1240) for assisting an operator in manipulating the support (1214), such as selectively coupling the support (1214) to the support base (1216) and / or selectively removing the support (1214) from the support base (1216). A coupling member in the form of a plug (1260) extends downwardly from the distal end of the support body (1240) for facilitating such selective coupling of the support (1214) to the support base (1216) and removal from the support base. In the example shown, the plug (1260) includes a pair of laterally opposed deflectable beams (1262) (one shown) configured to provide a snap-fit ​​engagement with corresponding portions of the support base (1216).

[0112] In this regard, the support base (1216) of the present example includes a generally arched plate (1270) and a central socket (1272) extending through the arched plate (1270), the central socket being configured to selectively receive the plug (1260) and thereby selectively couple the support (1214) to the support base (1216). For example, the perimeter of the socket (1272) may be configured to provide a snap-fit ​​engagement with the deflectable beam (1262) of the plug (1260). Although the plug (1260) and the socket (1272) are shown, it should be understood that the support (1214) may be selectively coupled to the support base (1216) in any other suitable manner. For example, the support (1214) may be selectively coupled to the support base (1216) via a magnetic attraction between a first magnet (not shown) of the support (1214) and a second magnet (not shown) of the support base (1216). Additionally or alternatively, the bracket (1214) may be selectively coupled to the bracket base (1216) via a hook and loop fastener (not shown).

[0113] In the illustrated example, the arched plate (1270) has a generally concave bottom (1274) whose contour is complementary to the upper region of the operator's wrist so that the arched plate (1270) can fit snugly against the operator's wrist. To this end, the support base (1216) also includes a pair of opposing slots (1276) configured to receive a wrist strap (1218), which can define a loop sized and configured to receive the operator's wrist, thereby securing the fluid source assembly (1210) to the operator's wrist. In this manner, the syringes (1212a, 1212b) can be operably mounted to the operator's wrist and thereby supported via the wrist strap (1218). In some versions, wristband (1218) may include quick-connect members in the form of first and second buckles (not shown), a strap with a hook-and-loop fastening feature, or other features that are configured to selectively couple to each other to close a loop defined by wristband (1218) and selectively decouple to each other to open a loop defined by wristband (1218), such as to assist an operator in donning and removing wristband (1218). Additionally or alternatively, wristband (1218) may include an elastomeric material to facilitate sliding of wristband (1218) over an operator's fist. Various other suitable ways in which wristband (1218) may be configured will be apparent to those of skill in the art in view of the teachings herein.

[0114] In some versions, the fluid source assembly (1210) can be secured to the wrist of the same hand that an operator uses to grasp the handle body (1120) of the fluid injection device (1110). This arrangement can limit potential movement of the syringes (1212a, 1212b) relative to the device (1110), such as in a direction away from the device (1110); and can thereby minimize the risk of the syringes (1212a, 1212b) pulling the device (1110) via the respective supply tubes (1181a, 1181b). For example, such an arrangement can reduce the weight of the syringes (1212a, 1212b) on the device (1110), as would be the case if the syringes (1212a, 1212b) were simply suspended from the device (1110) via the supply tubes (1181a, 1181b). In some versions, the supply tubes (1181a, 1181b) can be provided with sufficient slack to allow a certain degree of movement of the instrument (1110) relative to the fluid source assembly (1210) while an operator grasps the handle body (1120) with the same hand to which the fluid source assembly (1210) is secured so as to enable the instrument (1110) to be pivoted or otherwise manipulated without the syringe (1212a, 1212b) pulling the instrument (1110) through the corresponding supply tube (1181a, 1181b).

[0115] Referring now to FIGS. 14 to 15B , the pressure control delivery assembly (1310) of the present example includes a fluid selection device (1312) coupled to a pressurized fluid medium source (1314) ( FIG. 5 ) via a fluid medium supply tube (1316) and coupled to first and second syringe adapters (1318a, 1318b) via first and second fluid medium delivery tubes (1319a, 1319b), respectively. The pressurized fluid medium source (1314) may include any suitable pressurized fluid medium, such as air. Other suitable fluid media that may be used will be apparent to those skilled in the art in light of the teachings herein. The pressurized fluid medium source (1314) may be operably coupled to a fluid pump (not shown) operable to pressurize the fluid medium. In some versions, the pressurized fluid medium source (1314) may also be operably coupled to a pressure regulator (not shown) operable to regulate the fluid pressure of the pressurized fluid medium output from the pump. In view of the teachings herein, various suitable forms that such pumps and / or regulators may take will be apparent to those skilled in the art. By way of example only, such pumps and / or regulators may be configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,258,502. That patent, entitled “Therapeutic Agent Delivery Device,” was issued on April 16, 2019, the disclosure of which is incorporated herein by reference.

[0116] The fluid selection device (1312) of the present example includes a generally disc-shaped rigid manifold (1320), a valve assembly (1322), and a selector knob (1324). In the example shown, the manifold (1320) is formed by first and second housings (e.g., halves) (1320a, 1320b), the first housing and the second housing being fixedly coupled to each other (1326) along the longitudinal centerline of the manifold (1320) via a plurality of fasteners in the form of screws, such that the housings (1320a, 1320b) collectively define the manifold (1320). The housings (1320a, 1320b) may each be manufactured by 3D printing, injection molding, investment casting, machining, and / or any other suitable manufacturing technique, and subsequently assembled to each other to form the manifold (1320). It should be understood that the manifold (1320) may be formed in any other suitable manner. For example, the housings (1320a, 1320b) may be integrally formed with one another as a single (eg, unitary) piece to define the manifold (1320), such that corresponding pairs of engagement features may be omitted.

[0117] As shown, the manifold (1320) defines an internal cavity (1330) that is configured to at least partially accommodate various components of the valve assembly (1322), the fluid medium supply tube (1316), the fluid medium delivery tubes (1319a, 1319b), and the selection knob (1324). In this regard, the manifold (1320) of the present example further includes a proximal hole (1331) configured to accommodate a portion of the fluid medium supply tube (1316) and a distal hole (1332) configured to accommodate a portion of the fluid medium delivery tubes (1319a, 1319b), so that the fluid medium supply tube (1316) can extend out of the inner cavity (1330) via the proximal hole (1331), and the fluid medium delivery tubes (1319a, 1319b) can extend out of the inner cavity (1330) via the distal hole (1332). In the example shown, a plurality of internal baffles (1334) partially extend through the internal cavity (1330) and are spaced apart from one another to accommodate corresponding portions of the valve assembly (1322), thereby securely retaining the valve assembly (1322) within the internal cavity (1330). The manifold (1320) of the present example also includes an upper aperture (1336) configured to rotatably accommodate a lower portion of the selector knob (1324).

[0118] The valve assembly (1322) of the present example is in the form of a three-way stopcock. The valve assembly (1322) of the present example includes a generally T-shaped valve body (1340) having an inlet port (1342) and first and second outlet ports (1344a, 1344b). The valve assembly (1322) also includes a flow selector (1346) pivotably coupled to the valve body (1340) for selectively placing the inlet port (1342) in fluid communication or not in fluid communication with each of the outlet ports (1344a, 1344b). In this regard, the flow selector (1346) is pivotable between a closed state (not shown), in which the inlet port (1342) is fluidly isolated from the other outlet ports (1344a, 1344b), a first open state (FIG. 15A), and a second open state (FIG. 15B), in which the inlet port (1342) is fluidly connected to the first outlet port (1344a) and fluidly isolated from the second outlet port (1344b), and in which the inlet port (1342) is fluidly connected to the second outlet port (1344b) and fluidly isolated from the first outlet port (1344a). The selector knob (1324) is fixedly coupled to the flow selector (1346) so that an operator can pivot the flow selector (1346) between the open state and the closed state by rotating the selector knob (1324).

[0119] In the example shown, the fluid medium supply tube (1316) extends between an open proximal end (1350) and an open distal end (1351) and defines an inner cavity (1352) extending therebetween for directing air (or other fluid medium) therethrough. The open proximal end (1350) is fluidly coupled to a pressurized fluid medium source (1314) via a pneumatic fitting (1353), and the open distal end (1351) is fluidly coupled to the inlet port (1342) via a pneumatic fitting (1354). In the illustrated example, the fluid medium supply tube (1316) extends through the proximal hole (1331) of the manifold (1320) such that the open distal end (1351) is located within the inner cavity (1330) of the manifold (1320) for connection to the inlet port (1342), and the open proximal end (1350) is located outside the manifold (1320) for connection to the pressurized fluid medium source (1314).

[0120] Each fluid medium delivery tube (1319a, 1319b) extends between an open proximal end (1355a, 1355b) and an open distal end (1356a, 1356b) and defines an inner lumen (1357a, 1357b) extending therebetween for directing fluid therethrough. Each open proximal end (1355a, 1355b) is fluidly coupled to a corresponding outlet port (1344a, 1344b) via a corresponding pneumatic fitting (1358a, 1358b), and each open distal end (1356a, 1356b) is fluidly coupled to a corresponding syringe adapter (1318a, 1318b), as described in more detail below. In the example shown, the fluid medium delivery tubes (1319a, 1319b) each extend through the distal aperture (1332) of the manifold (1320) such that the open proximal ends (1355a, 1355b) are located within the interior cavity (1330) of the manifold (1320) for connection to the respective outlet ports (1344a, 1344b) while the open distal ends (1356a, 1356b) are located outside the manifold (1320) for connection to the respective syringe adapters (1318a, 1318b). In the example shown, the portions of the fluid medium delivery tubes (1319a, 1319b) extend parallel to each other and are wrapped together in a braided sleeve (1359).

[0121] Each syringe adapter (1318a, 1318b) of this example has a proximal end (1360a, 1360b) and a distal end (1362a, 1362b). Each proximal end (1360a, 1360b) has a barbed connection feature (1364a, 1364b) that is suitable for connecting to a corresponding tubing (1365a, 1365b), which in turn is suitable for connecting to a corresponding fluid medium delivery tube (1319a, 1319b). Each distal end (1362a, 1362b) includes a tubular member (1366a, 1366b) having an annular recess (not shown) for accommodating a corresponding gasket in the form of an O-ring (1368a, 1368b). Each tubular member (1366a, 1366b) is sized and configured to be received in the second opening of the corresponding syringe barrel (1220a, 1220b), and each O-ring (1368a, 1368b) is configured to provide a fluid-tight seal between the inner cavity of the corresponding syringe (1212a, 1212b) and the corresponding syringe adapter (1318a, 1318b) to prevent fluid pressure from escaping from the second opening of the corresponding syringe barrel (1220a, 1220b). An inner cavity (not shown) extends between each proximal end (1360a, 1360b) and each distal end (1362a, 1362b). Flanges 1370a, 1370b are disposed between the proximal end (1360a, 1360b) and the distal end (1362a, 1362b) of each syringe adapter (1318a, 1318b). In the present example, each syringe adapter (1318a, 1318b) is a single unitary body, but in other examples may include multiple parts coupled together. In view of the teachings herein, various other suitable ways in which syringe adapters (1318a, 1318b) may be configured will be apparent to those skilled in the art. By way of example only, each syringe adapter (1318a, 1318b) may be configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,258,502. The patent is entitled "Therapeutic Agent Delivery Device" and was issued on April 16, 2019, the disclosure of which is incorporated herein by reference.

[0122] As discussed in more detail below, the proximal ends (1360a, 1360b) of the syringe adapters (1318a, 1318b) can each be selectively coupled to a pressurized fluid medium source (1314), and the distal ends (1362a, 1362b) of the syringe adapters (1318a, 1318b) can each be received in a corresponding syringe (1212a, 1212b). Thus, pressurized air (or other fluid medium) can selectively communicate to the inner cavity of the first syringe 1212a via the first adapter 1318a proximal to the piston (1232a), and cause the piston (1232a) to advance within the first syringe 1212a, thereby dispensing fluid from the first syringe 1212a. Likewise, pressurized air (or other fluid medium) may be selectively communicated to the lumen of the second syringe 1212b via the second adapter 1318b proximate to the piston (1232b), and cause the piston (1232b) to advance within the second syringe (1212b), thereby dispensing fluid from the second syringe (1212b). In some cases, any adapter (1318a, 1318b) may be used to selectively transmit aspiration to the lumen of the corresponding syringe (1212a, 1212b) proximate to the corresponding piston (1232a, 1232b), and cause the corresponding piston (1232a, 1232b) within the corresponding syringe (1212a, 1212b) to retract, thereby drawing fluid into the corresponding syringe (1212a, 1212b).

[0123] When the flow selector (1346) of the valve assembly (1322) is in the first open state shown in Figure 15A, pressurized air (or other fluid medium) can pass from the pressurized fluid medium source (1314) through the inner cavity (1352) of the fluid medium supply tube (1316), through the inlet port (1342) and the first outlet port 1344a of the valve body (1340), through the inner cavity 1357a of the first fluid medium delivery tube 1319a, through the inner cavity 1318a of the first adapter, and into the inner cavity of the first syringe 1212a to advance the piston (1232a), thereby dispensing the bubble fluid (340) from the first syringe 1212a into the first Luer connector (1180a). The bubble fluid (340) can then travel in the downstream direction along the aforementioned flow path to be delivered at the inclined distal end (1144) of the inner cannula (1135) of the fluid injection device (1110). In this regard, the advancement of the piston (1232a) can cause the fluid pressure within the first proximal fluid supply channel (1188a) of the device (1110) to reach the aforementioned threshold fluid pressure, so that the first membrane (1199a) of the first Belleville valve (1183a) can immediately bend toward a corresponding open state to allow the bubble fluid (340) to flow through the first fluid channel (1194a) in the downstream direction. This prevention of the advancement of the piston (1232a) can cause the fluid pressure in the first proximal fluid supply channel (1188a) of the instrument (1110) to drop below the aforementioned threshold fluid pressure, so that the first membrane (1199a) of the first Belleville valve (1183a) can immediately elastically return to the corresponding closed state to stop the flow of the bubble fluid (340) in the downstream direction through the first fluid passage (1194a), while also preventing reverse flow in the upstream direction.

[0124] When the flow selector (1346) of the valve assembly (1322) is in the second open state shown in Figure 15B, pressurized air (or other fluid medium) can pass from the pressurized fluid medium source (1314) through the inner cavity (1352) of the fluid medium supply tube (1316), through the inlet port (1342) and the second outlet port (1344b) of the valve body (1340), through the inner cavity 1357b of the second fluid medium delivery tube 1319b, through the inner cavity 1318b of the second adapter, and into the inner cavity of the second syringe (1212b) for advancing the piston (1232b), thereby dispensing the therapeutic fluid (341) from the second syringe (1212b) into the second Luer connector (1180b). The therapeutic fluid (341) can then travel in the downstream direction along the above-mentioned flow path to be delivered at the inclined distal end (1144) of the inner cannula (1135) of the fluid injection device (1110). In this regard, the advancement of the piston (1232b) can cause the fluid pressure in the second proximal fluid supply channel (1188b) of the device (1110) to reach the aforementioned threshold fluid pressure, so that the second membrane (1199b) of the second Belleville valve (1183b) can immediately bend to a corresponding open state to allow the therapeutic fluid (341) to flow in the downstream direction through the second fluid channel 1194b. This prevention of the advancement of the piston (1232b) can cause the fluid pressure in the second proximal fluid supply channel (1188b) of the instrument (1110) to drop below the aforementioned threshold fluid pressure, so that the second membrane (1199b) of the second Belleville valve (1183b) can immediately elastically return to the corresponding closed state to stop the flow of the therapeutic fluid (341) in the downstream direction through the second fluid passage 1194b, while also preventing backflow in the upstream direction.

[0125] It should be appreciated that the pressure controlled delivery assembly (1310) can enable rapid switching between advancement of the pistons (1232a, 1232b) and thus between pumping the fluids (340, 341) to the corresponding fluid supply tubes (1181a, 1181b) for delivery at the angled distal end 1144 of the inner cannula (1135). It should also be appreciated that the fluid selection device (1312) of the pressure controlled delivery assembly (1310) can be remotely located relative to the syringes (1212a, 1212b). For example, the fluid source assembly (1210) including the syringes (1212a, 1212b) can be secured to the operator's wrist as described above, while the fluid selection device (1312) can be located elsewhere in the sterile environment where the procedure is performed (e.g., out of reach of the operator), such as on an instrument table or in the hands of a technician, with fluid medium delivery tubes (1319a, 1319b) and braided sleeve (1359) that are long enough to accommodate the operator's necessary movements relative to the fluid selection device (1312). In this way, the technician can manipulate the selector knob (1324) to quickly switch between pumping of fluids (340, 341) while the operator focuses on maintaining the angled distal end (1144) of the inner cannula (1135) in the subretinal space. In other words, such remote positioning of the fluid selection device (1312) relative to the syringes (1212a, 1212b) can enable someone other than the operator to control the delivery of the fluids (340, 341) at the angled distal end (1144). However, in some cases, the fluid selection device (1312) can be located within reach of the operator, allowing the operator to control the delivery of the fluids (340, 341) at the angled distal end (1144). For example, the fluid selection device (1312) can be secured to the operator (e.g., secured to the same wrist to which the fluid source assembly (1210) is secured or along the operator's forearm) in a manner similar to that described above with respect to the fluid source assembly (1210). In some such cases, the length of the fluid medium delivery tubes (1319a, 1319b) and the braided sleeve (1359) can be relatively short (e.g., less than or equal to the length of the operator's forearm), while the fluid medium supply tube (1316) can be long enough to accommodate the operator's necessary movement relative to the pressurized fluid medium source (1314).

[0126] It should therefore be understood that the system (1000) including the fluid injection apparatus (1110), the fluid source assembly (1210), and the pressure-controlled delivery assembly (1310) can be used to perform the subretinal delivery (341) of the bubble fluid (340) and therapeutic agent described above with respect to Figures 3 through 4J. Other suitable ways in which the system (1000) including the fluid injection apparatus (1110), the fluid source assembly (1210), and / or the pressure-controlled delivery assembly (1310) can be used will be apparent to those of skill in the art in view of the teachings herein.

[0127] B. Example 2 of the subretinal injection system

[0128] FIG. 16 illustrates an example of a system (2000) comprising a fluid injection device (2110), a fluid source assembly (2210), and a pressure-controlled delivery assembly (2310) for delivering one or more fluids during a procedure to treat an eye, such as subretinal delivery of the therapeutic agent (341) described above. System 2000 can be configured and operated like system (1000) described above, except as otherwise described below. Although fluid injection device (2110), fluid source assembly (2210), and pressure-controlled delivery assembly (2310) are described below in conjunction with system 2000, it should be understood that any one of the fluid injection device (2110), fluid source assembly (2210), and / or pressure-controlled delivery assembly (2310) can be readily incorporated into system (1000) described above. For example, fluid injection device (2110) can be easily incorporated into system (1000) in place of fluid injection device (1110); fluid source assembly (2210) can be easily incorporated into system (1000) in place of fluid source assembly (1210); and / or pressure control delivery assembly (2310) can be easily incorporated into system (1000) in place of pressure control delivery assembly (1310).

[0129] Referring primarily to Figures 17 to 19, and continuing to refer to Figure 16, the fluid injection device (2110) can be configured and operated like the above-described device (1110), except as otherwise described below. In this regard, the fluid injection device (2110) of this example includes a handle assembly (2112), a fluid supply assembly (2114), a fluid delivery assembly (2116), and an actuation assembly (2118).

[0130] The handle assembly (2112) of this example includes a rigid handle body (2120) and a cannula hub 2121. In some versions, the handle assembly (2112) may also include a strain relief (not shown) similar to the strain relief (1122). In the example shown, the handle body (2120) is formed by a first shell (e.g., half) (2120a, 2120b), and the first shell and the second shell are fixedly coupled to each other along the longitudinal centerline of the handle body (2120) via corresponding pairs of engagement features (e.g., interlocking detents and notches), so that the shells (2120a, 2120b) together define the handle body (2120).

[0131] As shown, the handle body (2120) defines an internal cavity (2124) that is configured to at least partially accommodate various components of the fluid supply assembly (2114), the fluid delivery assembly (2116), and the actuation assembly (2118). In this regard, the handle body (2120) of the present example further includes a proximal hole (2125) configured to accommodate a portion of the fluid supply assembly (2114) and a distal hole (2126) configured to accommodate a portion of the fluid delivery assembly (2116), such that the fluid supply assembly (2114) can extend out of the internal cavity (2124) via the proximal hole (2125), and the fluid delivery assembly (2116) can extend out of the internal cavity (2124) via the distal hole (2126). In the illustrated example, the cannula hub (2121) is fixedly coupled to the handle body (2120) within the internal cavity (2124) and includes a central hole (2129) configured to accommodate a portion of the fluid delivery assembly (2116) such that the cannula hub (2121) can provide support for the fluid delivery assembly (2116) within the internal cavity (2124).

[0132] The handle body (2120) of the present example further includes a pivot pin (2130) extending transversely through the interior cavity (2124) and configured to be pivotally received by a corresponding portion of the actuation assembly (2118), and an upper slot (2131) located generally above the pivot pin (2130) and configured to expose a corresponding portion of the actuation assembly (2118) to the exterior of the handle body (2120), as described in more detail below. In the illustrated example, the handle body (2120) further includes a plurality (e.g., four) longitudinal rails (2132) (two are shown) configured to slidably support a corresponding portion of the actuation assembly (2118).

[0133] Fluid delivery assembly (2116) of the present example comprises an outer cannula (2134) and an inner cannula (2135) that are similar to outer cannula (1134) and inner cannula (1135), respectively, described above.

[0134] The actuation assembly (2118) of the present example includes a pivotable roller (2150), a translatable cannula slide plate (2151), and a translatable cannula support tube (2152) configured to cooperate with each other to drive the inner cannula (2135) to translate relative to the outer cannula (2134). In the example shown, the roller (2150) is pivotally coupled to the handle body (2120) and includes a generally arcuate gripping portion (2153) and a pair of laterally opposed arms (2154) extending generally downward from the gripping portion (2153). The roller (2150) of the present example further includes a pair of pivot holes (2155), each of which extends transversely through the lower portion of the corresponding arm 2154 and is configured to pivotally receive the pivot pin (2130) of the handle body (2120) for pivotally coupling the roller (2150) to the handle body (2120) so that the roller (2150) can pivot about a pivot axis defined by the pivot pin (2130) and the pivot hole (2155) between an unactuated state and at least one actuated state (such as a fully actuated state). In this regard, the grip portion (2153) can be at least partially exposed to the exterior of the handle body (2120) via the upper slot (2131) to enable an operator to access and manipulate the grip portion (2153) between the unactuated and fully actuated states, for example, with the operator's thumb.

[0135] In the illustrated example, the roller (2150) further includes a pair of parallel flanges (2156) extending generally downwardly from the gripping portion (2153) between the arms (2154) and having opposing, generally flat cam surfaces (2157) spaced apart from one another to define a receptacle (2158) configured to receive a portion of the cannula slide (2151).

[0136] In this regard, the cannula slide (2151) of the present example is translationally coupled to the handle body (2120) and includes a slide housing (2160). As shown in FIG. 18, the slide housing (2160) includes a roller (2163) and a yoke (2164) extending distally from the roller (2163) and having a generally spherical distal hook (2165) extending generally upward to provide accommodation within the socket (2158) of the roller (2150). In the example shown, the coupling (2165) has a generally C-shaped cam surface (2166) that is configured to cammingly engage one or both planar cam surfaces 2157 of the roller (2150) to convert pivoting of the roller (2150) into translation of the cannula sled (2151) such that the cannula sled (2151) can longitudinally translate between a proximal position and a distal position in response to pivoting of the roller (2150) between an unactuated and fully actuated state. The roller (2163) of the present example includes a plurality (e.g., four) lateral protrusions (2167) (two are shown) that are configured to be slidably received between corresponding pairs of longitudinal guides (2132) of the handle body (2120) such that interaction between the guides (2132) and the protrusions (2167) can guide the cannula slide (2151) in longitudinal translation between a proximal position and a distal position during pivoting of the roller (2150) between an unactuated and a fully actuated state.

[0137] As shown, the yoke (2164) of the slide housing (2160) further includes a central hole (2168) configured to securely receive the cannula support tube (2152) to secure the cannula support tube (2152) to prevent it from moving relative to the slide housing (2160) so that the cannula support tube (2152) can translate longitudinally with the cannula slide (2151). In this regard, the central hole (2168) has an inner cross-sectional dimension (e.g., diameter) that is substantially equal to the outer cross-sectional dimension (e.g., diameter) of the cannula support tube (2152) to provide a friction fit therebetween. In the example shown, the proximal end of the outer cannula (2134) is disposed distal to the central hole (2168). The roller (2163) of the slide housing (2160) further includes a chamber (2169) disposed proximal to the central aperture (2168) and configured to securely retain at least a portion of the fluid supply assembly (2114). In this regard, the roller (2163) includes a pair of laterally opposed apertures (2176) (one shown) configured to selectively receive a retaining pin (2177) for retaining various components of the fluid supply assembly (2114) within the chamber (2169).

[0138] In the example shown, the cannula support tube (2152) is slidably received within the outer cannula (2134); and is configured to securely receive the inner cannula (2135) to secure the inner cannula (2135) to prevent it from moving relative to the cannula support tube (2152) (and therefore relative to the connecting member 2162) so that the inner cannula (2135) can translate longitudinally with the cannula support tube (2152) and the cannula slide (2151).

[0139] The fluid supply assembly (2114) of the present example includes first and second Luer connectors (2180a, 2180b), first and second fluid supply tubes (2181a, 2181b), a fluid supply connector (2182), first and second self-actuated check valves (2183a, 2183b), a valve retainer (2184), a generally oblong O-ring (2191) and a generally circular O-ring (2196), similar to the first and second Luer connectors (1180a, 1180b), first and second fluid supply tubes (1181a, 1181b), a fluid supply connector (1182), first and second self-actuated check valves (1183a, 1183b), a valve retainer (1184), a generally oblong O-ring (1191) and a generally circular O-ring (1196).

[0140] As shown, the fluid supply connector (2182) and the valve retainer (2184) are each securely retained within the chamber (2169) of the slide housing (2160) of the actuator assembly (2118). More specifically, the retaining pin (2177) (FIG. 17) captures the fluid supply connector (2182) and the valve retainer (2184) within the chamber (2169). The O-ring (2191) provides a fluid-tight seal between the fluid supply connector (2182) and one side of the chamber (2169), while the O-ring (2196) provides a fluid-tight seal between the valve retainer (2184) and the distal end of the chamber (2169). Thus, the various components of the fluid supply assembly (2114) may be securely retained directly within the chamber (2169) of the slider housing (2160), rather than being contained within a connecting member that is securely retained within the chamber (2169) of the slider housing (2160).

[0141] Referring now to FIGS. 20 to 23 , the fluid source assembly (2210) can be configured and operated like the fluid source assembly (1210) described above, except as otherwise described below. In this regard, the fluid source assembly (2210) of the present example includes a first fluid source and a second fluid source in the form of syringes (2212a, 2212b), a syringe holder (2214), and a wearable component in the form of a magnetic cuff (2218). As shown, each syringe (2212a, 2212b) includes a barrel (2220a, 2220b) having a distal end 2222a, 2222b, a proximal end (2224a, 2224b), and an inner cavity (not shown) extending therebetween. Each distal end (2222a, 2222b) includes a first dispensing opening (2226a, 2226b) and a threaded portion (2228a, 2228b) that is capable of coupling the corresponding syringe (2212a, 2212b) to a needle, tube, or the like. In the illustrated example, the threaded portions (2228a, 2228b) are configured to threadably engage first and second Luer fittings (2180a, 2180b), respectively, to fluidly couple the corresponding lumens of the syringes (2212a, 2212b) to the corresponding lumens of the supply tubes (2181a, 2181b). In this regard, the lumen of the first syringe 2220a contains a bubble fluid 340, while the lumen of the second syringe 2220b contains a therapeutic fluid (341). Each proximal end (2224a, 2224b) includes a second opening (2230a, 2230b) configured to accommodate a corresponding plunger (2232a, 2232b). The proximal end (2224a, 2224b) of each syringe barrel (2220a, 2220b) includes a flange (2234a, 2234b) that extends radially outward relative to the longitudinal axis of the corresponding syringe (2212a, 2212b) and can be used as a finger grip when a user holds the corresponding syringe (2212a, 2212b).

[0142] The syringe support (2214) of the present example includes a support body (2240) having a pair of parallel longitudinal sheaths (2241a, 2241b), the sheaths defining corresponding holes (2242a, 2242b), configured to selectively retain corresponding syringe barrels (2220a, 2220b) for selectively securing syringes (2212a, 2212b) to the syringe support (2214). In this regard, each hole (2242a, 2242b) may have an inner cross-sectional dimension (e.g., diameter) that is at least slightly larger than the outer cross-sectional dimension (e.g., diameter) of the corresponding syringe barrel (2220a, 2220b). In the example shown, each sheath (2241a, 2241b) includes a corresponding elongated slot (2243a, 2243b) to enable visual observation of the corresponding syringe barrel (2220a, 2220b) passing therethrough. More specifically, an upper elongated slot (2243a) extends through the top of the first sheath (2241a) to enable visual observation of the first syringe barrel (2220a) passing therethrough, and a transverse elongated slot (2243b) extends through the transverse outer side (2241b) of the second sheath to enable visual observation of the second syringe barrel (2220b) passing therethrough.

[0143] In this regard, the support body (2240) of the present example also has a central body portion (2244) extending between the sheaths (2241a, 2241b) and defining an illumination chamber (2245), which leads to the second hole (2242b) via a side hole (2246). A pendant light port (2247) extends through the proximal wall of the central body portion (2244) to the illumination chamber (2245) and securely holds a pendant light socket (2248), which is sized and configured to selectively accommodate a pendant light, such as a fiber optic pendant light (2249), to allow the illumination end of the pendant light (2249) to be disposed in and / or illuminate the illumination chamber (2245). It should be understood that the light emitted by the pendant light (2249) can enter the second hole (2242b) from the illumination chamber (2245) through the side hole (2246), and can thereby illuminate the second syringe barrel (2220b). This illumination of the second syringe barrel (2220b) can be visually observed through the transverse elongated slot (2243b). In this way, the pendant light (2249) can be configured to provide backlighting of the second syringe barrel (2220b), which can help the operator determine the amount of therapeutic agent (341) remaining in the lumen of the second syringe (2220b) and / or a certain amount of therapeutic agent (341) that has been dispensed from the first opening 2226b of the second syringe (2220b). While the pendant light socket (2248) has been described as being used to selectively receive the pendant light (2249), in some other versions, the pendant light (2249) may be permanently coupled to the bracket body (2240), and the lighting end of the pendant light (2249) may be permanently disposed within the lighting chamber (2245). Additionally or alternatively, the pendant light (2249) may include a light source, such as a light emitting diode (LED), disposed within the lighting chamber (2245).

[0144] In the example shown, a pair of collars (2250a, 2250b) are located at the proximal end of the support body (2240) and aligned with corresponding holes (2242a, 2242b). The collars (2250a, 2250b) enable the corresponding syringes (2212a, 2212b) to be coupled to a system having one or more power components, as described in more detail below. Each collar (2250a, 2250b) can be used to secure a corresponding portion of the pressure control delivery assembly (2310) (e.g., a syringe adapter (2318a, 2318b) described below) to the proximal end (2224a, 2224b) of the syringe (2212a, 2212b) and thereby prevent these portions of the pressure control delivery assembly (2310) from moving relative to the respective syringe (2212a, 2212b). In this regard, each collar (2250a, 2250b) defines a corresponding proximally facing recess (2251a, 2251b) that is sized and configured to accommodate at least a portion of the flange (2234a, 2234b) of the corresponding syringe (2212a, 2212b) and / or the pressure control delivery assembly (2310). In the example shown, a pair of retaining projections (2253a, 2253b) are configured to hold the pressure control delivery assembly (2310) in place. The corresponding portion of the syringe (2212a, 2212b) is clamped against the flange (2234a, 2234b) of the corresponding syringe (2212a, 2212b) within the recess (2251a, 2251b) of the corresponding collar (2250a, 2250b). In the example shown, the retaining protrusion (2253a, 2253b) is provided on a corresponding deflectable beam (2255a, 2255b) extending along the bottom of the corresponding collar (2250a, 2250b). In other versions, the deflectable beam (2255a, 2255b) can extend along the side (e.g., the lateral outside) of the corresponding collar (2250a, 2250b). Each recess (2251a, 2251b) of the present example includes at least one corresponding keyway (2257a, 2257b), wherein the first recess (2251a) The at least one keyway (2257a) of the second groove 2251b has a unique configuration (eg, size, shape, and / or angular position) relative to the at least one keyway 2257b of the second groove 2251b, the purpose of which is described below.

[0145] As shown, a coupling member in the form of a magnet (2260) is disposed on the underside of the bracket body (1240) that provides a magnetic attraction to the magnetic cuff (2218) to facilitate selective coupling of the bracket (2214) to the magnetic cuff (2218) and removal of the bracket from the magnetic cuff. In this regard, the magnetic cuff (2218) of this example includes one or more ferrous elements (e.g., ferrous metal filings embedded in the cuff material, a single thin metal sheet embedded in the cuff material, etc.) that provide a magnetic attraction to the magnet (2260). In some other versions, the magnetic cuff (2218) includes an array of magnetic elements that provide a magnetic attraction to the magnet (2260). In view of the teachings herein, various suitable features and configurations that may be incorporated into the magnetic cuff (2218) to provide a magnetic attraction to the magnet (2260) will be apparent to those of ordinary skill in the art. The magnetic cuff (2218) can define a loop that is sized and configured to accommodate the operator's wrist, thereby securing the fluid source assembly (2210) to the operator's wrist. In this manner, the syringe (2212a, 2212b) can be operably mounted to the operator's wrist, thereby being supported via the magnetic cuff (2218). In some versions, the magnetic cuff (2218) can include a quick-connect member in the form of first and second buckles (not shown), a strap with a hook-and-loop fastening feature, or other features configured to selectively couple to each other to close the loop defined by the magnetic cuff (2218) and selectively decouple from each other to open the loop defined by the magnetic cuff (2218), such as to assist the operator in donning and removing the magnetic cuff (2218). Additionally or alternatively, the magnetic cuff (2218) can include an elastomeric material to facilitate sliding the magnetic cuff (2218) over the operator's fist. Various other suitable ways in which magnetic cuff (2218) may be configured will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0146] Referring now to FIG24, the pressure control delivery assembly (2310) can be similar to the pressure control delivery assembly (1310) described above, except as otherwise described below. In this regard, the pressure control delivery assembly (2310) of the present example includes a fluid selection device (2312) coupled to a pressurized fluid medium source (2314) (FIG. 16) via a fluid medium supply tube (2316) and coupled to first and second syringe adapters (2318a, 2318b) via first and second fluid medium delivery tubes (2319a, 2319b), respectively.

[0147] The fluid selection device (2312) of the present example includes a generally disc-shaped rigid manifold (2320), a valve assembly (2322), and a selector knob (2324). In the example shown, the manifold (2320) is formed by first and second housings (e.g., halves) (2320a, 2320b), the first housing and the second housing being fixedly coupled to each other (2326) along the longitudinal centerline of the manifold (2320) via a plurality of fasteners in the form of screws, such that the housings (2320a, 2320b) collectively define the manifold (2320).

[0148] As shown, the manifold (2320) defines an internal cavity (2330) that is configured to at least partially accommodate various components of the valve assembly (2322), the fluid medium supply tube (2316), the fluid medium delivery tubes (2319a, 2319b), and the selection knob (2324). In this regard, the manifold (2320) of the present example further includes a proximal hole (2331) configured to accommodate a portion of the fluid medium supply tube (2316) and a distal hole (2332) configured to accommodate a portion of the fluid medium delivery tube (2319a, 2319b), so that the fluid medium supply tube (2316) can extend out of the inner cavity (2330) via the proximal hole (2331), and the fluid medium delivery tubes (2319a, 1319b) can extend out of the inner cavity (2330) via the distal hole (2332). In the example shown, a plurality of internal baffles (2334) partially extend through the internal cavity (2330) and are spaced apart from one another to accommodate corresponding portions of the valve assembly (2322), thereby securely retaining the valve assembly (2322) within the internal cavity (2330). The manifold (2320) of the present example also includes an upper aperture (2336) configured to rotatably accommodate a lower portion of the selector knob (2324).

[0149] The valve assembly (2322) of the present example is in the form of a three-way stopcock. The valve assembly (2322) of the present example includes a generally T-shaped valve body (2340) having an inlet port (2342) and first and second outlet ports (2344a, 2344b). The valve assembly (2322) also includes a flow selector (2346) pivotally coupled to the valve body (2340) for selectively connecting and disconnecting the inlet port (2342) from each outlet port (2344a, 2344b) in a manner similar to that described above in conjunction with FIGS. 15A to 15B.

[0150] In the example shown, the fluid medium supply tube (2316) extends between an open proximal end (2350) and an open distal end (2351) and defines an inner cavity (2352) extending therebetween for directing air (or other fluid medium) therethrough. The open proximal end (2350) is fluidly coupled to a pressurized fluid medium source (2314) via a pneumatic fitting (2353), and the open distal end (2351) is fluidly coupled to the inlet port (2342) via a pneumatic fitting (2354).

[0151] Each fluid medium delivery tube (2319a, 1319b) extends between an open proximal end (2355a, 1355b) and an open distal end (2356a, 1356b) and defines an inner cavity (2357a, 1357b) extending therebetween for directing fluid therethrough. Each open proximal end (2355a, 1355b) is fluidly coupled to a corresponding outlet port (2344a, 1344b) via a corresponding pneumatic fitting (2358a, 1358b), and each open distal end (2356a, 1356b) is fluidly coupled to a corresponding syringe adapter (2318a, 1318b), as described in more detail below.

[0152] Each syringe adapter (2318a, 2318b) of this example has a proximal end (2360a, 2360b) and a distal end (2362a, 2362b). Each proximal end (2360a, 2360b) has a hollow connection feature (2364a, 2364b) suitable for connecting to a corresponding fluid medium delivery tube (2319a, 2319b). Each distal end (2362a, 2362b) includes a tubular member (2366a, 2366b) having an annular recess (not shown) for accommodating a corresponding gasket in the form of an O-ring (2368a, 2368b). Each tubular member (2366a, 2366b) is sized and configured to be received in the second opening of the corresponding syringe barrel (2220a, 2220b), and each O-ring (2368a, 2368b) is configured to provide a liquid-tight seal between the inner cavity of the corresponding syringe (2212a, 2212b) and the corresponding syringe adapter (2318a, 2318b) to prevent fluid pressure from escaping from the second opening of the corresponding syringe barrel (2220a, 2220b). An inner cavity (not shown) extends between each proximal end (2360a, 2360b) and each distal end (2362a, 2362b). Flanges 2370a, 2370b are disposed between the proximal end (2360a, 2360b) and the distal end (2362a, 2362b) of each syringe adapter (2318a, 2318b).

[0153] As discussed in more detail above in conjunction with Figures 14 to 15B, the proximal ends (2360a, 2360b) of the syringe adapters (2318a, 2318b) can each be selectively connected to a pressurized fluid medium source (2314), and the distal ends (2362a, 2362b) of the syringe adapters (2318a, 2318b) can each be received in the second opening of the corresponding syringe (2212a, 2212b). In this regard, each flange (2370a, 2370b) of the present example includes at least one corresponding key (2371a, 2371b) configured to be received within a corresponding keyway (2257a, 2257b) of the recess (2251a, 2251b), wherein at least one key (2371a) of the first flange (2370a) has a unique configuration (e.g., size, shape, and / or angular position) relative to at least one key (2371b) of the second flange (2370b). More specifically, at least one key (2371a) of the first flange (2370a) is configured to be received in at least one keyway (2257a) of the first recess (2251a), but not in at least one keyway (2257b) of the second recess (2251b); and at least one key (2371b) of the second flange (2370b) is configured to be received in at least one keyway (2257b) of the second recess (2251b), but not in at least one keyway (2257a) of the first recess (2251a). In this way, the keys (2371a, 2371b) of the flanges (2370a, 2370b) and the keyways (2257a, 2257b) of the recesses (2251a, 2251b) can cooperate with each other to inhibit the distal ends (2362a, 2362b) of the syringe adapters (2318a, 2318b) from being inadvertently received in the second opening of an incorrect syringe (2212a, 2212b), thereby ensuring that pressurized air (or other fluid medium) is selectively connected to the inner cavity of the first syringe (2212a) via the first adapter (2318a), and ensuring that pressurized air (or other fluid medium) is selectively connected to the inner cavity of the second syringe (2212b) via the second adapter (2318b).

[0154] It should therefore be understood that the system (2000) including the fluid injection apparatus (2110), the fluid source assembly (2210), and the pressure-controlled delivery assembly (2310) can be used to perform the subretinal delivery (341) of the bubble fluid (340) and therapeutic agent described above with respect to Figures 3 through 4J. Other suitable ways in which the system (2000) including the fluid injection apparatus (2110), the fluid source assembly (2210), and / or the pressure-controlled delivery assembly (2310) can be used will be apparent to those of skill in the art in view of the teachings herein.

[0155] Although systems (1000, 2000) including fluid injection devices (1110), (2110), fluid source components (1210, 2210), and pressure controlled delivery components (1310, 2310) have been described in the context of delivering bubble fluid (340) and therapeutic agent (341) to the subretinal space via a transvitreal, transretinal approach, it should be understood that the various components of either system (1000, 2000) may be used to deliver bubble fluid (340) and / or therapeutic agent (341) to the subretinal space via any other suitable type of method. In some versions, either fluid supply assembly (1114, 2114) can be readily incorporated into a fluid injection device configured to deliver a bubble fluid (340) and / or a therapeutic agent (341) to the subretinal space via a suprachoroidal approach, such as by selectively fluidly coupling a first conduit and a second conduit to a needle of such a fluid injection device to supply the bubble fluid (340) and the therapeutic agent 341 to the needle. For example, either fluid supply assembly (1114, 2114) can be readily incorporated into a fluid injection device configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,646,374. That patent, entitled “Device and method for forming an access bubble for subretinal delivery of a therapeutic agent,” issued May 12, 2020, the disclosure of which is incorporated herein by reference.

[0156] IV. Combination Examples

[0157] The following examples relate to various non-exhaustive ways in which the teachings of this article may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be filed at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this article may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, any aspect or feature mentioned below should not be considered critical unless otherwise explicitly indicated by the inventor or the inventor's successor at a later date. If any claim filed in this application or a subsequent application related to this application includes additional features beyond those mentioned below, it should not be presumed that these additional features are added for any reason related to patentability.

[0158] Example 1

[0159] A device comprising: (a) a body; (b) an outer cannula extending distally from the body along a longitudinal axis, wherein the outer cannula is securely secured to the body, wherein the outer cannula comprises: (i) a proximal portion having a first cross-sectional dimension, and (ii) a distal portion having at least one of the first cross-sectional dimension that is smaller than a second cross-sectional dimension, wherein the distal portion is configured to guide the cylindrical proximal portion into a trocar port to advance the outer cannula into an eye of a patient; and (c) an inner cannula extending along the longitudinal axis and slidably disposed in the outer cannula for longitudinal translation relative to the outer cannula, wherein the inner cannula comprises: (i) an open proximal end, (ii) an open distal end configured to pierce the retina of the eye, and (iii) A lumen extends between the open proximal end and the open distal end, wherein the lumen is configured to transfer at least one fluid from the open proximal end to the open distal end to deliver the at least one fluid to a subretinal region of the eye.

[0160] Example 2

[0161] A device according to Example 1, wherein the distal portion tapers radially inward in a distal direction.

[0162] Example 3

[0163] A device according to Example 1, wherein the distal portion is bent radially inward in the distal direction.

[0164] Example 4

[0165] A device according to any of Examples 1 to 3, wherein the proximal portion is substantially cylindrical.

[0166] Example 5

[0167] The device of Example 4 wherein the distal portion is substantially frustoconical.

[0168] Example 6

[0169] A device according to any one of Examples 1 to 5, wherein the proximal portion defines a proximal opening, wherein the distal portion defines a distal opening that is smaller than the proximal opening.

[0170] Example 7

[0171]

[00136] According to Example 6, the distal opening is configured to maintain the inner cannula centered relative to the outer cannula during longitudinal translation of the inner cannula relative to the outer cannula.

[0172] Example 8

[0173] A device according to any of Examples 1 to 7, wherein the open distal end is beveled.

[0174] Example 9

[0175] The device of Example 8 wherein the open distal end is oriented at an angle of approximately 45 degrees relative to the longitudinal axis.

[0176] Example 10

[0177] A device according to any one of Examples 1 to 9, wherein the outer tube is rigid.

[0178] Example 11

[0179] A device according to any one of Examples 1 to 10, wherein the outer tube comprises a metal material.

[0180] Example 12

[0181] The device of Example 11, wherein the outer cannula comprises surgical stainless steel.

[0182] Example 13

[0183] A device according to any one of Examples 1 to 12, wherein the inner tube is flexible.

[0184] Example 14

[0185] The device of any one of Examples 1 to 13, wherein the inner cannula comprises a polymeric material.

[0186] Example 15

[0187] The device of Example 14, wherein the inner tube comprises polyimide.

[0188] Example 16

[0189] According to the device described in any one of Examples 1 to 15, the at least one fluid includes a first fluid and a second fluid, and the device further includes a first proximal fluid supply channel and a second proximal fluid supply channel, and the first proximal fluid supply channel and the second proximal fluid supply channel are configured to be selectively fluidically connected to the inner cavity of the inner tube to supply the first fluid and the second fluid to the inner cavity, respectively.

[0190] Example 17

[0191]

[00136] According to Example 16, the device further comprises first and second valves configured to selectively fluidly couple the first and second proximal fluid supply channels, respectively, to the lumen of the inner cannula.

[0192] Example 18

[0193] A device according to Example 17, wherein the first valve and the second valve include a first Belleville valve and a second Belleville valve, respectively.

[0194] Example 19

[0195] A device according to any one of Examples 17 to 18, wherein the first valve and the second valve are each configured to connect the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel fluid to the inner cavity of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being equal to or greater than a threshold fluid pressure.

[0196] Example 20

[0197] A device according to Example 19, wherein the first valve and the second valve are each configured to isolate the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel from the inner cavity fluid of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being less than the threshold fluid pressure.

[0198] Example 21

[0199] An apparatus comprising: (a) a wearable component configured to be worn by an operator; and (b) at least one syringe supported by the wearable component, wherein the at least one syringe is configured to dispense at least one fluid into a fluid injection device held by the operator.

[0200] Example 22

[0201] An apparatus according to Example 21, wherein the wearable component includes at least one of a wristband or a cuff configured to be secured to the operator's wrist.

[0202] Example 23

[0203] A device according to any of Examples 21 to 22, wherein the at least one syringe comprises a pair of syringes.

[0204] Example 24

[0205] The device of any one of Examples 21 to 23, further comprising a bracket configured to hold the at least one syringe, wherein the bracket is coupled to the wearable component.

[0206] Example 25

[0207] A device according to Example 24, wherein the bracket is removably connected to the wearable component.

[0208] Example 26

[0209] A device according to Example 25, wherein the bracket is removably connected to the wearable component via magnetic attraction.

[0210] Example 27

[0211] The device of any one of Examples 24 to 26, wherein the support includes an illumination chamber configured to accommodate an illumination portion of a chandelier for illuminating the at least one syringe.

[0212] Example 28

[0213] The device according to Example 27 further includes a chandelier socket configured to selectively accommodate the chandelier.

[0214] Example 29

[0215] The device of any of Examples 27-28, wherein the bracket includes a hole configured to accommodate the at least one syringe, wherein the illumination chamber opens to the hole via an orifice.

[0216] Example 30

[0217] The device according to any one of Examples 27 to 29 further includes the chandelier, wherein the chandelier includes the lighting part, and the lighting part is disposed in the lighting chamber of the bracket.

[0218] Example 31

[0219] A device comprising: (a) a first syringe, the first syringe comprising: (i) a first proximal end, (ii) a first distal end, the first distal end being configured to dispense a first fluid, and (iii) a first piston, the first piston being disposed between the first proximal end and the first distal end; (b) a second syringe, the second syringe comprising: (i) a second proximal end, (ii) a second distal end, the second distal end being configured to dispense a second fluid, and (iii) a second piston, the second piston being disposed between the second proximal end and the second distal end; (c) a source of pressurized fluid medium; (d) an inlet port, the inlet port being fluidly coupled to the source of pressurized fluid medium; (e) a first outlet port, the first outlet port being fluidly coupled to the first proximal end of the first syringe; (f) a second outlet port, the second outlet port being fluidly coupled to the second proximal end of the second syringe; and (g) a fluid selector, the fluid selector being capable of changing between: (i) a closed state, in which the inlet port is fluidly isolated from each of the first outlet port and the second outlet port, and (ii) a closed state. The invention relates to a first open state in which the inlet port is fluidly isolated from the second outlet port and in which the inlet port is fluidly connected to the first outlet port for guiding pressurized fluid medium from the pressurized fluid medium source to the first proximal end of the first syringe to advance the first piston distally and thereby dispense the first fluid from the first distal end, and (iii) a second open state in which the inlet port is fluidly isolated from the first outlet port and in which the inlet port is fluidly connected to the second outlet port for guiding pressurized fluid medium from the pressurized fluid medium source to the second proximal end of the second syringe to advance the second piston distally and thereby dispense the second fluid from the second distal end.

[0220] Example 32

[0221] The device of Example 31, wherein the first fluid comprises a biologically inert bubble fluid and wherein the second fluid comprises a biologically active therapeutic fluid.

[0222] Example 33

[0223] A device comprising: (a) a body; (b) an outer cannula extending distally from the body; (c) an inner cannula slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, wherein the inner cannula comprises: (i) an open proximal end, (ii) an open distal end configured to pierce a layer of an eye of a patient to access a subretinal region of the eye, and (iii) an inner lumen extending between the open proximal end and the open distal end, wherein the inner lumen is configured to transfer a first fluid and a second fluid from the open proximal end to the open distal end to deliver the first fluid and the second fluid to the subretinal region of the eye; and (d) A fluid supply assembly, the fluid supply assembly comprising: (i) a first proximal fluid supply channel and a second proximal fluid supply channel, the first proximal fluid supply channel and the second proximal fluid supply channel being configured to selectively fluidically connect to the inner cavity of the inner tube to supply the first fluid and the second fluid to the inner cavity, respectively, and (ii) a first Belleville valve and a second Belleville valve, the first Belleville valve and the second Belleville valve being configured to selectively fluidically connect the first proximal fluid supply channel and the second proximal fluid supply channel to the inner cavity of the inner tube, respectively.

[0224] Example 34

[0225] A device according to Example 33, wherein the first Belleville valve and the second Belleville valve are each configured to connect the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel fluid to the inner cavity of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being equal to or greater than a threshold fluid pressure.

[0226] Example 35

[0227] A device according to any one of Examples 33 to 34, wherein the first Belleville valve and the second Belleville valve are each configured to isolate the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel from the inner cavity fluid of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being less than the threshold fluid pressure.

[0228] V. Others

[0229] It should be understood that any version of the apparatus described herein may include various other features in addition to or in place of the features described above. By way of example only, any device herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0230] 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. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be viewed in isolation from each other. In view of the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0231] It should be understood that any patent (publication) or other public material deemed to be incorporated by reference herein is incorporated herein in whole or in part only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly set forth herein supersedes any conflicting material incorporated by reference herein. Any material or portion thereof deemed to be incorporated by reference herein but that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0232] The above versions can be designed to be discarded after a single use, or they can be designed for multiple uses. In either or both cases, the versions can be adjusted for reuse after at least one use. Adjustment can include any combination of steps of disassembling the device, subsequently cleaning or replacing specific parts, and subsequently reassembling. Specifically, some versions of the device can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, some versions of the device can be reassembled at an adjustment facility for subsequent use, or reassembled by an operator immediately before surgery. Those skilled in the art will appreciate that the adjustment of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting adjusted devices are within the scope of the present application.

[0233] By way of example only, the versions described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and device can 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 can kill bacteria on the device and in the container. The sterilized device can then be stored in the sterilization container for later use. The device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0234] Various embodiments of the present invention have been shown and described, and further modifications to the methods and systems described herein may be accomplished by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such potential modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the appended claims, and should be understood not to be limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A device comprising: (a) Subject; (b) an outer cannula extending distally from the body along a longitudinal axis, wherein the outer cannula is fixedly secured to the body, wherein the outer cannula comprises: (i) a proximal portion having a first cross-sectional dimension, and (ii) a distal portion having at least one second cross-sectional dimension that is smaller than the first cross-sectional dimension, wherein the distal portion is configured to guide the cylindrical proximal portion into a trocar port to advance the outer cannula into an eye of a patient; (c) an inner cannula extending along the longitudinal axis and slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, wherein the inner cannula comprises: (i) an open proximal end, (ii) an open distal end configured to pierce a retina of the eye, and (iii) an inner cavity extending between the open proximal end and the open distal end, wherein the inner cavity is configured to transfer at least one fluid from the open proximal end to the open distal end to deliver the at least one fluid to the subretinal region of the eye.

2. The device of claim 1, wherein the distal portion tapers radially inwardly in a distal direction.

3. The device of claim 1, wherein the distal portion curves radially inward in a distal direction.

4. The device according to any one of claims 1 to 3, wherein the proximal portion is substantially cylindrical.

5. The device of claim 4, wherein the distal portion is generally frustoconical.

6. The device of any one of claims 1 to 5, wherein the proximal portion defines a proximal opening, wherein the distal portion defines a distal opening that is smaller than the proximal opening.

7. The device of claim 6, wherein the distal opening is configured to maintain the inner cannula centered relative to the outer cannula during longitudinal translation of the inner cannula relative to the outer cannula.

8. The device of any one of claims 1 to 7, wherein the open distal end is beveled.

9. The device of claim 8, wherein the open distal end is oriented at an angle of approximately 45 degrees relative to the longitudinal axis.

10. The device according to any one of claims 1 to 9, wherein the outer cannula is rigid.

11. The device according to any one of claims 1 to 10, wherein the outer cannula comprises a metallic material.

12. The device of claim 11, wherein the outer cannula comprises surgical stainless steel.

13. The device according to any one of claims 1 to 12, wherein the inner cannula is flexible.

14. The device of any one of claims 1 to 13, wherein the inner cannula comprises a polymeric material.

15. The device of claim 14, wherein the inner cannula comprises polyimide.

16. The device according to any one of claims 1 to 15, wherein the at least one fluid comprises a first fluid and a second fluid, and the device further comprises a first proximal fluid supply channel and a second proximal fluid supply channel, wherein the first proximal fluid supply channel and the second proximal fluid supply channel are configured to be selectively fluidically connected to the inner cavity of the inner tube to supply the first fluid and the second fluid to the inner cavity, respectively.

17. The device of claim 16, further comprising first and second valves configured to selectively fluidly couple the first and second proximal fluid supply channels, respectively, to the lumen of the inner cannula.

18. The device of claim 17, wherein the first valve and the second valve comprise a first Belleville valve and a second Belleville valve, respectively.

19. The device according to any one of claims 17 to 18, wherein the first valve and the second valve are each configured to connect the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel fluid to the inner cavity of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being equal to or greater than a threshold fluid pressure.

20. The device of claim 19, wherein the first valve and the second valve are each configured to isolate the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel from the inner cavity fluid of the inner cannula in response to the fluid pressure within the corresponding first fluid channel or the corresponding second fluid channel being less than the threshold fluid pressure.

21. An apparatus comprising: (a) a wearable component configured to be worn by an operator; and (b) at least one syringe supported by the wearable component, wherein the at least one syringe is configured to dispense at least one fluid into a fluid injection device held by the operator.

22. The apparatus of claim 21, wherein the wearable component comprises at least one of a wristband or a cuff configured to be secured to the operator's wrist.

23. The device according to any one of claims 21 to 22, wherein the at least one syringe comprises a pair of syringes.

24. The device according to any one of claims 21 to 23, further comprising a bracket configured to hold the at least one syringe, wherein the bracket is coupled to the wearable component.

25. The apparatus of claim 24, wherein the support is removably coupled to the wearable component.

26. The apparatus of claim 25, wherein the bracket is removably coupled to the wearable component via magnetic attraction.

27. The device of any one of claims 24 to 26, wherein the support comprises an illumination chamber configured to accommodate an illumination portion of a pendant light for illuminating the at least one syringe.

28. The apparatus of claim 27, further comprising a pendant light socket configured to selectively receive the pendant light.

29. The device according to any one of claims 27 to 28, wherein the support comprises a hole configured to accommodate the at least one syringe, wherein the illumination chamber opens into the hole via an orifice.

30. The device according to any one of claims 27 to 29, further comprising the chandelier, wherein the chandelier includes the lighting portion, wherein the lighting portion is disposed within the lighting chamber of the support.

31. An apparatus comprising: (a) a first syringe, the first syringe comprising: (i) a first proximal end, (ii) a first distal end configured to dispense a first fluid, and (iii) a first piston disposed between the first proximal end and the first distal end; (b) a second syringe, the second syringe comprising: (i) a second proximal end, (ii) a second distal end configured to dispense a second fluid, and (iii) a second piston disposed between the second proximal end and the second distal end; (c) a source of pressurized fluid medium; (d) an inlet port fluidly coupled to the source of pressurized fluid medium; (e) a first outlet port fluidly coupled to the first proximal end of the first syringe; (f) a second outlet port fluidly coupled to the second proximal end of the second syringe; and (g) a fluid selector capable of changing between: (i) a closed state in which the inlet port is fluidly isolated from each of the first outlet port and the second outlet port, (ii) a first open state in which the inlet port is fluidly isolated from the second outlet port and in which the inlet port is fluidly coupled to the first outlet port for directing pressurized fluid medium from the pressurized fluid medium source to the first proximal end of the first syringe to advance the first piston distally and thereby dispense the first fluid from the first distal end, and (iii) a second open state, in which the inlet port is fluidly isolated from the first outlet port and in which the inlet port is fluidly connected to the second outlet port for directing pressurized fluid medium from the pressurized fluid medium source to the second proximal end of the second syringe to advance the second piston distally and thereby dispense the second fluid from the second distal end.

32. The device of claim 31, wherein the first fluid comprises a biologically inert bubble fluid, and wherein the second fluid comprises a biologically active therapeutic fluid.

33. An apparatus comprising: (a) Subject; (b) an outer cannula extending distally from the body; (c) an inner cannula slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, wherein the inner cannula comprises: (i) an open proximal end, (ii) an open distal end configured to pierce the layers of an eye of a patient to access a subretinal region of the eye, and (iii) a lumen extending between the open proximal end and the open distal end, wherein the lumen is configured to convey a first fluid and a second fluid from the open proximal end to the open distal end to deliver the first fluid and the second fluid to the subretinal region of the eye; and (d) a fluid supply assembly, the fluid supply assembly comprising: (i) a first proximal fluid supply channel and a second proximal fluid supply channel, the first proximal fluid supply channel and the second proximal fluid supply channel being configured to be selectively fluidly coupled to the lumen of the inner cannula to supply the first fluid and the second fluid, respectively, to the lumen, and (ii) first and second Belleville valves configured to selectively fluidly couple the first and second proximal fluid supply channels, respectively, to the lumen of the inner cannula.

34. The device of claim 33, wherein the first Belleville valve and the second Belleville valve are each configured to fluidically couple a corresponding first proximal fluid supply channel or a corresponding second proximal fluid supply channel to the inner cavity of the inner tube in response to a fluid pressure within the corresponding first fluid channel or the corresponding second fluid channel being equal to or greater than a threshold fluid pressure.

35. The device according to any one of claims 33 to 34, wherein the first Belleville valve and the second Belleville valve are each configured to isolate the corresponding first proximal fluid supply channel or the corresponding second proximal fluid supply channel from the inner cavity fluid of the inner tube in response to the fluid pressure in the corresponding first fluid channel or the corresponding second fluid channel being less than the threshold fluid pressure.

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