Subretinal syringe for vitreous body

Abstract

The device includes a body and an outer cannula that extends distally along a longitudinal axis from the body and is fixedly 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 the trocar port. The device also includes an inner cannula that is slidably disposed within the outer cannula for translational movement in a direction parallel to the longitudinal axis of the outer cannula. The inner cannula includes an open proximal end, an open distal end configured to puncture the retina of the eye, and a lumen that extends between the open proximal end and the open distal end. The lumen is configured to allow fluid to flow from the open proximal end to the open distal end for delivering fluid to the subretinal region of the eye.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Patent Application No. 63 / 388,150, filed Jul. 11, 2022, entitled “Transvitreal Subretinal Injector”, the disclosure of which is incorporated herein by reference.

Background Art

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

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

[0004] Various surgical methods and instruments have been created and used to treat the eye, but none of the inventors believe that anyone prior to them has made or used the invention described in the appended claims.

Brief Description of the Drawings

[0005] This specification concludes with claims particularly pointing out and distinctly claiming the technology, but the technology is believed to be better understood from the following description of specific examples in conjunction with the accompanying drawings, in which like reference numerals identify like elements.

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[0047] The drawings are not intended to be limiting in any way, and it is contemplated that various other embodiments of the technology can be implemented in various other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, illustrate some aspects of the technology and are useful in explaining the principles of the technology together with the description. However, it is understood that the technology is not limited to the exact arrangements shown.

DETAILED DESCRIPTION OF THE INVENTION

[0048] The following description of specific examples of the technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art from the following description, which is presented as an example of one of the best modes contemplated for carrying out the technology. As will be understood, the technology described herein is capable of other different obvious aspects without departing from the technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0049] It is further understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the teachings, expressions, embodiments, examples, etc. described below should not be viewed in isolation from one another. Various suitable ways in which the teachings of this specification may be combined will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the claims.

[0050] For the sake of clarity in the disclosure, the terms "proximal" and "distal" are defined herein with respect to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to the position of an element closer to the surgeon or other operator, and the term "distal" refers to the position of an element closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0051] I. Examples of Instruments for Delivering Therapeutic Agents from a Transretinal Approach

[0052] Figures 1 to 2B show an example of an instrument (110) that can be used to deliver bleb fluid (340) and therapeutic agent (341) to the subretinal space from a transvitreal, transretinal approach through a single lumen of a single tip. As best shown in Figure 1, the instrument (110) of this example includes a pair of luer fittings (195, 196), a fluid supply guide (192), supply tubes (190, 191) fluidly connected to the luer fittings (195, 196) respectively, a body (140), a slider (200), and a fluid delivery assembly (130). The luer fittings (195, 196) can be connected to two different fluid sources such as a prior bleb (340) fluid and a therapeutic fluid (341). The luer fittings (195, 196) are respectively connected to tube lines (193, 194) that terminate within the fluid supply guide (192). Although conventional luer fittings (195, 196) are used in this embodiment, any other suitable type of fitting may be used.

[0053] The fluid supply guide (192) holds the tube lines (193, 194) 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. The fluid supply guide (192) provides dedicated paths for fluid flow from the tube line (193) to the supply tube (190) and from the tube line (194) to the supply tube (191). It should be understood that the fluid supply guide keeps the path associated with the tube line (193) and the supply tube (190) separate from the path associated with the tube line (194) and the supply tube (191). The fluid sources coupled to the luer fittings (195, 196) can be pressurized either manually (e.g., using a syringe, etc.) or automatically (e.g., using a pump). The operator may then select which fluid source to pressurize in order to selectively pump the fluids (340, 341) into the corresponding supply tubes (190, 191).

[0054] 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) that is inserted into the patient's eye (301). The inner cannula (131) is longitudinally slidable relative to the outer cannula (120) and the body (140). In particular, the inner cannula (131) is longitudinally driven by a slider (200).

[0055] As best seen in FIGS. 2A-2B, the slider (200) is slidably coupled to the body (140). The slider (200) can translate from a proximal position as shown in FIG. 2A to a distal position as shown in FIG. 2B. The 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 both supply tubes (190, 191).

[0056] In this embodiment, the distal end of the inner cannula (131) is cut in the same plane such 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 this embodiment, the distal end of the inner cannula (131) is not sharp. Nevertheless, due to the small diameter of the inner cannula (131), the column strength of the material forming the inner cannula (131), and the fragility of the retina (308), the distal end of the inner cannula (131) can penetrate the retina (308) as described below despite the blunt configuration of the distal end of the inner cannula (131). In some other versions, the distal end of the inner cannula (131) is sharp or has some other configuration.

[0057] Accordingly, the inner cannula (131) can penetrate the retina (308) and deliver fluid from any of the supply tubes (190, 191) to the subretinal space. An example of a method of using the device (110) will be described in more detail below. Other suitable ways in which the device (110) may be modified and used will be apparent to those skilled in the art in view of the teachings herein. By way of example only, the device (110) may be constructed and operative in accordance with at least some of the teachings of U.S. Patent No. 10,639,193, entitled "Therapeutic Agent Delivery Device with Convergent Lumen," issued May 5, 2020, the disclosure of which is incorporated herein by reference.

[0058] II. Example of a method of delivering a therapeutic agent from a transretinal approach

[0059] Figures 3-4J illustrate a method of using the device (110) to provide ipsilateral or transvitreal administration of a therapeutic agent (341) to the subretinal space of a patient.

[0060] As shown in FIG. 3, the procedure is initiated by the operator fixing the tissue (e.g., the eyelid) around the patient's eye (301) using a speculum (312) and / or any other suitable instrument for fixation. The fixation is described herein with reference to the tissue surrounding the eye (301), but it should be understood that the eye (301) itself can move freely. Once the tissue around the eye (301) is fixed, an intraocular shunt port (314) is inserted into the eye (301) to provide intraocular illumination when the interior of the eye (301) is viewed through the pupil. In this example, the intraocular shunt port (314) is placed in the inferomedial quadrant. Further, a vitrectomy port (317) is inserted into the eye (301) to provide access for performing a standard three-port pars plana core vitrectomy. In this example, the vitrectomy port (317) is placed in the superotemporal quadrant. Also, a third port (318) is inserted into the eye (301) to provide access to a device for administering a therapeutic fluid (341) into the subretinal space of the eye (301). In this example, the third port (318) is placed in the superomedial quadrant. The various suitable forms that the ports (314, 317, 318) can take will be apparent to those skilled in the art in view of the teachings herein.

[0061] As seen in FIG. 4A, an ophthalmic chandelier port (314) is positioned to direct light into 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 the area of the eye (301) that is targeted for delivery of a therapeutic agent (341). An optical fiber (315) is inserted into the port (314) to provide the illumination. A microscope may optionally be utilized to visually inspect the eye to confirm proper positioning of the ophthalmic chandelier port (314) relative to the target site. Although FIG. 4A shows a particular positioning of the ophthalmic chandelier port (314), it should be understood that the ophthalmic chandelier port (314) may have any other positioning that would be apparent to one of ordinary skill in the art in view of the teachings herein. Further, a conventional vitrectomy instrument (400) is inserted through a vitrectomy port (317) to perform a conventional three-port pars plana core vitrectomy procedure. After completion of the conventional three-port pars plana core vitrectomy procedure, the vitrectomy instrument (400) is removed.

[0062] Before or after completion of a conventional three-port pars plana vitrectomy procedure, an instrument (110) may be prepared for subretinal administration of a therapeutic fluid (341). By way of mere example, preparation of the instrument (110) may include coupling a luer fitting (195) to a source of the therapeutic fluid (341) and coupling a luer fitting (196) to a fluid source that directs an anterior bubble (340) fluid. Next, the fluid source may be pressurized to prime fluid flow components that communicate with and include the lumen of the inner cannula (131) until droplets of the anterior bubble fluid (340) or the therapeutic fluid (341) exit the distal end of the inner cannula (131). In some cases, the therapeutic fluid (341) is pressurized first, followed by pressurization of the anterior bubble (340) fluid source. In some other examples, the source of the anterior bubble (340) fluid is pressurized first, followed by pressurization of the source of the therapeutic fluid (341). In some other examples, both fluid sources are pressurized substantially simultaneously. It should also be understood that in some examples, a void may be provided between the anterior bubble (340) and the therapeutic fluid (341) to prevent mixing of the therapeutic fluid (341) with the anterior bubble (340). Various suitable ways of priming the instrument (110) with the primary bubble (340) fluid, 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.

[0063] After the instrument (110) has been primed, as shown in FIG. 4B, the outer cannula (120) is inserted into the third port (318). When the outer cannula (120) is inserted into the third port (318), the slider (200) is in the proximal position as shown in FIG. 2A, thereby ensuring that the distal end of the inner cannula (131) is disposed securely within the outer cannula (120). The outer cannula (120) is inserted to the point where the distal end of the outer cannula (120) is disposed adjacent to the interior of the retina (308).

[0064] When the distal end of the outer cannula (120) is disposed adjacent to the inside of the retina (308), the slider (200) is slid distally so that the distal end of the inner cannula (131) fixed to the distal end of the outer cannula (120) is exposed. Thus, as shown in FIG. 4C, the inner cannula (131) punctures the retina (308) to define a subretinal entry point (339).

[0065] When the distal end of the inner cannula (131) is disposed at a first position in the subretinal space through the subretinal entry point (339), the fluid source of the leading bleb (430) fluid is pressurized. This pressurization drives fluid through the lumen of the inner cannula (131) to form a leading bleb (340) in the subretinal space between the retina (308) and the choroid (306), as shown in FIG. 4D.

[0066] When the leading bleb (340) is formed at the first position in the subretinal space, the inner cannula (131) further advances distally via the actuation of the slider (200), whereby, as shown in FIGS. 4E - 4F, the inner cannula (131) advances downward along the coronal plane and backward along the sagittal plane. In particular, the inner cannula (131) first moves between the leading bleb (340) and the choroid (306) (FIG. 4E), and then passes through the leading bleb (340) and enters the space between the retina (308) and the choroid (306) (FIG. 4F). Thus, this advancement of the inner cannula (131) defines a path (342) between the retina (308) and the choroid (306).

[0067] When the inner cannula (131) reaches a second position in the subretinal space at the end of the path (342), the therapeutic agent (341) is injected into the subretinal region by pressurizing the fluid source of the therapeutic agent (341), and the therapeutic agent (341) is pushed distally through the lumen of the inner cannula (131), as shown in FIG. 4F.

[0068] When an appropriate amount of therapeutic fluid (341) is delivered to the second position, the slider (200) retracts proximally, thereby retracting the inner cannula (131) to the first position as shown in FIG. 4G. While the inner cannula (131) is retracted from the path (342), the leading bleb (340) fluid in the path (342) is discharged, and the leading bleb (340) fluid may be pressurized again to help seal it within the therapeutic fluid (341) at the second position.

[0069] As shown in FIG. 4G, when the inner cannula (131) retracts from the path (342), negative pressure may be induced via any of the supply tubes (190, 191) within the inner cannula (131) to aspirate the leading bleb (340) as shown in FIG. 4H. Optionally, negative pressure may be induced to aspirate the leading bleb (340) via other known means in the art, such as a separate flex tip insertion instrument (MedOne). After removing the instrument (110) from the eye (301), a separate flex tip insertion instrument or other conventional instrument may be inserted. In addition to or instead of aspirating the leading bleb (340), air or other fluid may be used to effectively tamponade the subretinal bleb (340).

[0070] After the leading bleb (340) has been aspirated or tamponaded, the instrument (110) is removed from the third port (318) as shown in FIG. 4I. Thereafter, a laser retinopexy tool (500) is inserted into the third port (318) and used to seal the subretinal entry point (339) as shown in FIG. 4J. Alternatively, any other suitable instrument or technique may be used to seal the subretinal entry point (339).

[0071] From the above, it should be understood that two different types of fluids (e.g., a pre - bleb (340) fluid and a therapeutic agent (341)) can be delivered to the sub - retinal space without the need to withdraw the inner cannula (131) from the sub - retinal space during the operation of delivering the first fluid (e.g., a pre - bleb (340) fluid) and the second fluid (e.g., a therapeutic agent (341)) using the instrument (110).

[0072] III. Example of a trans - vitreous sub - retinal injection system

[0073] In some cases, for example, to assist in the insertion of the outer cannula (120) into the trocar port (318) and / or to assist in maintaining the centering of the inner cannula (131) relative to the outer cannula (120) during the translation of the inner cannula (131) relative to the outer cannula (120) (e.g., by contacting or otherwise guiding the inner cannula (131)), it may be desirable to provide an outer cannula (120) having a tapered distal tip. Maintaining the centering of the inner cannula (131) relative to the outer cannula (120) may allow the inner cannula (131) to have a relatively high rigidity when the inner cannula (131) extends only slightly from the outer cannula (120), while still allowing the inner cannula (131) to have sufficient flexibility to move along the path (342) as the inner cannula (131) extends further from the outer cannula (120). The relatively high rigidity such that the inner cannula (131) first extends from the outer cannula (120) facilitates a controlled puncture of the retina (308) by the inner cannula (131), defines a sub - retinal entry point (339) at a desired location, and / or may define a controlled advancement of the inner cannula (131) after such a puncture of the retina (308), such as between the pre - bleb (340) and the choroid (306).

[0074] In addition to, or instead of, it may be desirable to attach a fluid source coupled to luer fittings (195, 196) so as to limit movement of the fluid source relative to the instrument (110). For example, it may be desirable to attach the fluid source so as to prevent inadvertent movement of the fluid source away from the instrument (110) which could otherwise result in pulling of the instrument (110) by the fluid source through the supply tubes (190, 191), thereby enabling accurate operation of the instrument (110). Additionally, or alternatively, it may be desirable to provide a fluid selection device that enables rapid switching between pumping of fluids (340, 341) into the corresponding supply tubes (190, 191), and / or to position the fluid selection device remotely relative to the fluid source itself.

[0075] Each of the examples of the systems (1000, 2000) described below may function in this manner and may be used to deliver one or more fluids, such as bleb fluid (340) and therapeutic agent (341), subretinally via a transvitreal, transretinal approach.

[0076] A. First example of a transvitreal subretinal injection system

[0077] FIG. 5 shows an example of a system (1000) including a fluid injection instrument (1110), a fluid source assembly (1210), and a pressure control delivery assembly (1310) for delivering one or more fluids during a procedure for treating an eye condition such as subretinal delivery of the therapeutic agent (341) described above.

[0078] Continuing to refer to FIG. 5 and primarily referring to FIGS. 6 - 12D, the fluid injection instrument (1110) may be similar to the instrument (110) described above, except as otherwise described hereinafter. In this regard, the fluid injection instrument (1110) of this example includes a handle assembly (1112), a fluid supply assembly (1114), a fluid delivery assembly (1116), and an actuation assembly (1118).

[0079] 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 an operator's single hand (e.g., either the left or right hand) via a power grip, a pencil grip, or any other suitable type of grip. In the illustrated example, the handle body (1120) is formed from a first and a second shell (e.g., halves) (1120a, 1120b) fixedly coupled to each other along the longitudinal centerline of the handle body (1120) via a corresponding pair of engagement mechanisms (e.g., a detent and a recess for interlocking) such that the shells (1120a, 1120b) collectively define the handle body (1120). The shells (1120a, 1120b) may each be manufactured by three-dimensional printing, injection molding, investment casting, machining, and / or any other suitable manufacturing technique and then assembled together to form the handle body (1120). It will be understood that the handle body (1120) may be formed in any other suitable manner. For example, the shells (1120a, 1120b) may be integrally formed with each other as a single (e.g., monolithic) component for defining the handle body (1120), and as a result, the corresponding pair of engagement mechanisms may be omitted.

[0080] As shown, the handle body (1120) defines an internal cavity (1124) configured to at least partially house various components of a fluid supply assembly (1114), a fluid delivery assembly (1116), and an actuation assembly (1118). In this regard, the handle body (1120) of the present example also includes a proximal bore (1125) configured to receive a portion of the fluid supply assembly (1114) and a distal bore (1126) configured to receive a portion of the fluid delivery assembly (1116), whereby the fluid supply assembly (1114) may extend from the internal cavity (1124) through the proximal bore (1125), and the fluid delivery assembly (1116) may extend from the internal cavity (1124) through the distal bore (1126). In the illustrated example, a pair of internal bridges (1127) extend laterally across the internal cavity (1124) and each include a central bore (1128) configured to receive a portion of the fluid delivery assembly (1116) such that the bridge (1127) may support the fluid delivery assembly (1116) within the internal cavity (1124). In the illustrated example, the cannula hub (1121) is fixedly coupled to the handle body (1120) within the internal cavity (1124) and includes a central bore (1129) configured to receive a portion of the fluid delivery assembly (1116) such that the cannula hub (1121) may support the fluid delivery assembly (1116) within the internal cavity (1124).

[0081] The handle body (1120) of the present example also includes a pair of laterally opposed pivot pins (1130) (one shown) extending inwardly in the lateral direction and configured to be pivotally received by corresponding portions of the actuation assembly (1118), and an upper slot (1131) disposed generally above the pivot pins (1130) and configured to expose corresponding portions of the actuation assembly (1118) outside of the handle body (1120), as will be described in more detail below. In the illustrated example, the handle body (1120) further includes a plurality (e.g., four) of longitudinal channels (1132) (two shown) configured to slidably receive corresponding portions of the actuation assembly (1118).

[0082] As shown, the strain relief (1122) is coupled to the proximal end of the handle body (1120) and defines a passageway (1133) that communicates with a proximal bore (1125) to direct the proximal portion of the fluid supply assembly (1114) away from the internal cavity (1124) in a proximal and / or transverse direction. In some versions, the strain relief (1122) may include a flexible material.

[0083] The fluid delivery assembly (1116) of the present embodiment includes an outer cannula (1134) and an inner cannula (1135). The outer cannula (1134) is similar to the outer cannula (120) described above, unless otherwise specifically described below, and the inner cannula (1135) is similar to the inner cannula (131) described above, unless otherwise specifically described below. In this regard, the outer and inner cannulas (1134, 1135) may be used with the remainder of the instrument (1110) in a similar manner as the outer and inner cannulas (120, 131) to perform the same procedures described above in connection with FIGS. 4A-4J. The outer cannula (1134) is sized and configured to be fixed to the handle body (1120) and pass through a trocar port (318) inserted into the patient's eye (301). As will be described in more detail below, the inner cannula (1135) is longitudinally slidable relative to the outer cannula (1134) and the handle body (1120) via an actuation assembly (1118). The outer cannula (1134) may be substantially rigid, while the inner cannula (1135) may be flexible. In some versions, the outer cannula (1134) may include a metallic material such as surgical stainless steel. Additionally, or alternatively, the inner cannula (1135) may include a polymeric material such as polyimide. Other suitable materials that may be used to form the outer cannula (1134) and / or the inner cannula (1135) will be readily apparent to those skilled in the art in view of the teachings herein.

[0084] In the illustrated example, the outer cannula (1134) extends between an open proximal end (1136) and an open distal end (1137). It defines an outer lumen (1138) that extends therebetween to slidably receive the inner cannula (1135) and a portion of the actuation assembly (1118). As best seen in FIGS. 11A-11B, the outer cannula (1134) includes a generally cylindrical proximal portion (1140) that extends distally from the proximal end (1136) and a generally frustoconical distal portion (1141) that tapers radially inwardly from the proximal portion (1140) toward the distal end (1137), whereby the distal portion (1141) may have at least one cross-sectional dimension (e.g., diameter) that is smaller than the cross-sectional dimension of the proximal portion (1140), and whereby it may be configured to assist in guiding the insertion of the outer cannula (1134) into the trocar port (318). For example, the distal portion (1141) may be sized and configured to leak into the trocar port (318), thereby guiding the proximal portion (1140) into the trocar port (318).

[0085] In addition or alternatively, the tapered configuration of the distal portion (1141) may be such that the outer lumen (1138) is constricted at the distal portion (1141) such that the distal end (1137) defines an opening that is smaller than the opening defined by the proximal end (1136). The relatively small opening defined by the distal end (1137) may assist in maintaining centering of the inner cannula (1135) relative to 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) through the distal end (1137) (e.g., ensuring a coaxial relationship between the inner cannula (1135) and the outer cannula (1134)). Such centering of the inner cannula (1135) relative to the outer cannula (1134) may enable the inner cannula (1135) to have a relatively high stiffness, such as during puncture of the retina (308), when the inner cannula (1135) extends slightly beyond the outer cannula (1134).

[0086] The distal portion (1141) of this example tapers radially inwardly from the proximal portion (1140) to the distal end (1137), but the distal portion (1141) may alternatively curve radially inwardly from the proximal portion (1140) to the distal end (1137). The proximal and distal portions (1140, 1141) of this example are integrally formed as an integral (e.g., monolithic) part to define the outer cannula (1134), but the proximal and distal portions (1140, 1141) may alternatively be formed separately from each other as separate pieces and connected to each other to define the outer cannula (1134).

[0087] One or more of the distal bore (1126) and / or the central bores (1128, 1129) of the handle assembly (1112) may be configured to receive the proximal portion (1140) of the outer cannula (1134) to fixedly secure the outer cannula (1134) to the handle body (1120). For example, one or more of the distal bore (1126) and / or the central bores (1128, 1129) may be configured to frictionally engage the generally cylindrical outer surface of the proximal portion (1140) of the outer cannula (1134) to fixedly secure the outer cannula (1134) to the handle body (1120). As shown, the fixed cannula support tube (1142) is fixed to the proximal portion (1140) of the outer cannula (1134) and is at least partially disposed within a part of the actuating assembly (1118) to further support the outer cannula (1134).

[0088] In the illustrated example, the inner cannula (1135) extends between an open proximal end (1143) and an open distal end (1144) and defines an inner lumen (1145) that extends therebetween for conducting fluid. As best seen in FIGS. 11A-11B, the distal end (1144) of the inner cannula (1135) is angled such that the distal end (1144) is oriented at an angle with respect to the longitudinal axis of the inner cannula (1135). The angle at which the distal end (1144) is oriented with respect to the longitudinal axis of the inner cannula (1135) may be, for example, about 45 degrees. In this way, the distal end (1144) of the inner cannula (1135) may be configured to be oriented generally parallel to the retinal pigment epithelium (RPE) of the eye (301) when the inner lumen (1145) is used to pierce the retina (308) to define a subretinal entry point (339) and / or form a pre-bleb (340) within the subretinal space, thereby reducing the risk that the distal end (1144) will perforate or otherwise cause undesirable trauma to the RPE and / or improving the formation of the pre-bleb (340).

[0089] The actuation assembly (1118) of this embodiment includes a pivotable scroll wheel (1150), a translatable cannula slider (1151), and a translatable cannula support tube (1152) configured to cooperate with each other to drive the translation of the inner cannula (1135) relative to the outer cannula (1134). In the illustrated example, the scroll wheel (1150) is pivotally coupled to the handle body (1120) and includes a generally arched grip portion (1153) and a pair of laterally opposed arms (1154) extending generally downwardly from the grip portion (1153). The scroll wheel (1150) of this embodiment also includes a pair of pivot bores (1155) (one is illustrated), each facing laterally outward from the lower portion of a respective arm (1154) and configured to pivotally receive a corresponding pivot pin (1130) of the handle body (1120) for pivotally coupling the scroll wheel (1150) to the handle body (1120). The scroll wheel (1150) may be pivotable about a pivot axis collectively defined by the pivot pin (1130) and the pivot bore (1155) between at least one actuation state, such as a non-actuated state (Figs. 9A, 10A, 12A) and a fully actuated state (Figs. 9B, 10B, 12B). In this regard, the grip portion (1153) may be at least partially exposed outside the handle body (1120) via an upper slot (1131) to allow, for example, an operator's thumb to access and manipulate the grip portion (1153) between the non-actuated state and the fully actuated state. In some versions, the handle body (1120) may include one or more stop elements configured to selectively engage a corresponding portion of the scroll wheel (1150) when the scroll wheel (1150) is pivoted to the non-actuated state and / or the fully actuated state to prevent further pivoting of the scroll wheel (1150) beyond the non-actuated state and / or the fully actuated state.

[0090] In the illustrated example, the scroll wheel (1150) also includes a pair of parallel flanges (1156) having opposing generally flat cam surfaces (1157) spaced apart from each other and defining a socket (1158) configured to extend generally downwardly from the grip portion (1153) between the arms (1154) and receive a portion of the cannula sled (1151).

[0091] With respect to this, the cannula sled (1151) of the present example is movably connected in parallel to the handle body (1120) and includes a thread housing (1160) and a connecting member (1162). As best shown in FIG. 8, the thread housing (1160) includes a drum (1163) and a yoke (1164) having a generally bulbous distal hitch (1165) that extends distally from the drum (1163) and extends generally upwardly so as to be received within the socket (1158) of the scroll wheel (1150). In the illustrated example, the hitch (1165) has a generally C-shaped cam surface (1166) configured to be cam engaged by one or both of the planar cam surfaces (1157) of the scroll wheel (1150) to convert the pivotal movement of the scroll wheel (1150) into a parallel movement of the cannula sled (1151), such that the cannula sled (1151) is longitudinally movable between a proximal position (FIGS. 10A and 12A) and a distal position (FIGS. 10B and 12B) in response to the pivotal movement of the scroll wheel (1150) between a non-operating state and a fully-operating state. The drum (1163) of the present embodiment includes a plurality (e.g., four) of longitudinal rails (1167) (two are shown) configured to be slidably received within a corresponding longitudinal channel (1132) of the handle body (1120), and the interaction between the channel (1132) and the rails (1167) can induce a longitudinal parallel movement of the cannula sled (1151) between a proximal position and a distal position during the pivotal movement of the scroll wheel (1150) between a non-operating state and a fully-operating state.

[0092] As shown, the yoke (1164) of the thread housing (1160) also includes a central bore (1168) configured to slidably receive the cannula support tube (1142), such that the outer cannula (1134) of the fluid delivery assembly (1116) can be supported by the cannula-less red (1151) via the cannula support tube (1142) without preventing longitudinal translation of the cannula-less red (1151). In this regard, the central bore (1168) 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 cannula support tube (1142). In the illustrated example, the proximal end (1136) of the outer cannula (1134) is disposed within the central bore (1168). The drum (1163) of the thread housing (1160) also includes a chamber (1169) disposed proximal to the central bore (1168) and configured to securely hold the connecting member (1162). In this regard, the longitudinal alignment slot (1170) extends distally from the proximal end of the drum (1163) through the sidewall of the drum (1163) to assist in facilitating proper alignment of the connecting member (1162) relative to the thread housing (1160) when the connecting member (1162) is loaded within the chamber (1169) of the drum (1163).

[0093] The connecting member (1162) of the present embodiment includes a drum (1171) and a tube grip (1172) extending distally from the drum (1171). As shown, the tube grip (1172) of the connecting member (1162) includes a central generally C-shaped recess (1173) configured to snugly receive the cannula support tube (1152) and secure the cannula support tube (1152) against movement relative to the connecting member (1162), whereby the cannula support tube (1152) can be translationally movable longitudinally with the cannula sled (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), providing a friction fit therebetween. In some versions, a lateral cover (not shown) may be secured to the side of the connecting member (1162) to capture the cannula support tube (1152) within the central recess (1173). For example, such a cover may include a central generally C-shaped recess that can be aligned with the central recess (1173) to collectively define a central bore configured to snugly receive the cannula support tube (1152).

[0094] In the illustrated example, 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) and fix the inner cannula (1135) against movement relative to the cannula support tube (and thus relative to the connection member (1162)), such that the inner cannula (1135) can translate longitudinally in parallel with the cannula support tube (1152) and the cannula ferrule (1151). In the illustrated example, the proximal end (1136) of the outer cannula (1134) is spaced from the tube grip (1172) by a distance sufficient to allow translation between the proximal and distal positions of the cannula ferrule (1151) without risk of collision between the tube grip (1172) and the proximal end (1136) of the outer cannula (1134). The drum (1171) of the connection member (1162) includes radially outwardly extending alignment projections (1174) configured to be slidably received within the alignment slots (1170) of the thread housing (1160) to maintain proper alignment of the connection member (1162) relative to the thread housing (1160). The drum (1171) also includes a chamber (1175) disposed proximal to the central recess (1173) and configured to securely hold at least a portion of the fluid supply assembly (1114). In this regard, the drum (1171) includes a pair of laterally opposed bores (1176) (one shown) configured to selectively receive retaining pins (1177) for holding various components of the fluid supply assembly (1114) within the chamber (1175).

[0095] The fluid supply assembly (1114) of the present embodiment includes first and second luer connectors (1180a, 1180b), first and second fluid supply tubes (1181a, 1181b), a fluid supply joint (1182), first and second self-actuating check valves (1183a, 1183b), and a valve holder (1184). In the illustrated example, each fluid supply tube (1181a, 1181b) extends between an open proximal end (not shown) and open distal ends (1186a, 1186b), and defines lumens (1187a, 1187b) that extend therebetween for guiding fluid. As will be described in more detail below, the open proximal ends of each fluid supply tube (1181a, 1181b) are fluidly connected to their respective luer connectors (1180a, 1180b), and each open distal end (1186a, 1186b) is fluidly connected to the fluid supply joint (1182). In the illustrated example, both fluid supply tubes (1181a, 1181b) extend through the proximal bore (1125) of the handle body (1120) and the passage (1133) of the strain relief (1122), and the open distal ends (1186a, 1186b) are disposed within the internal cavity (1124) of the handle body (1120) for coupling to the fluid supply joint (1182), and the open proximal ends of the fluid supply tubes (1181a, 1181b) are disposed outside the handle body (1120) for coupling to their respective luer connectors (1180a, 1180b). Each of the fluid supply tubes (1181a, 1181b) may be configured to slide through the proximal bore (1125) of the handle body (1120) and the passage (1133) of the strain relief (1122) to accommodate translational movement of the cannula sleeve (1151) relative to the handle body (1120). For example, distal translational movement of the cannula sleeve (1151) relative to the handle body (1120) may slightly pull the distal ends (1186a, 1186b) of the fluid supply tubes (1181a, 1181b) distally, as shown in FIGS. 10A-10B.In some versions, the supply tubes (1181a, 1181b) may be provided with sufficient slack within the internal cavity (1124) of the handle body (1120) such that the supply tubes (1181a, 1181b) do not necessarily slide through the proximal bore (1125) while the cannula-less red (1151) translates parallel to the handle body (1120).

[0096] The luer fittings (1180a, 1180b) may be connected to two different fluid supply sources, such as a source of the prior breb fluid (340) and a source of the therapeutic fluid (341), as will be described in more detail below, and may be selectively pressurized to selectively pump the fluids (340, 341) into the corresponding supply tubes (1181a, 1181b). Although conventional luer fittings (1180a, 1180b) are used in this embodiment, any other suitable type of fitting may be used.

[0097] As shown, a fluid supply joint (1182) and a valve holder (1184) are each firmly held within a chamber (1175) of a connecting member (1162) of an actuating assembly (1118). More specifically, a retaining pin (1177) (FIG. 6) captures the fluid supply joint (1182) and the valve holder (1184) within the chamber (1175). The fluid supply joint (1182) of this embodiment includes first and second proximal fluid supply flow paths (1188a, 1188b) that are fluid-isolated from each other and configured to fluidly couple to open distal ends (1186a, 1186b) of first and second fluid supply tubes (1181a, 1181b), respectively. In the illustrated example, the fluid supply joint (1182) includes first and second generally annular valve seats (1189a, 1189b) defined around the open distal ends of the respective fluid supply flow paths (1188a, 1188b) and inclined relative to each other so as to define a "V" shape, the purpose of which will be described below. As shown, a generally oval groove (1190) extends radially inward from a radially outer surface of the fluid supply joint (1182), and a proximal gasket in the form of a generally oval O-ring (1191) is disposed within the groove (1190) to provide a liquid seal between the fluid supply joint (1182) and a side surface of the chamber (1175).

[0098] The valve holder (1184) of this embodiment includes a single distal fluid supply flow path (1192) that is fluidly coupled to an inner lumen (1145) of an inner cannula (1135) and configured to selectively fluidly couple to the first and second proximal fluid supply flow paths (1188a, 1188b) of the fluid supply joint (1182). In this regard, the valve holder (1184) also includes first and second generally dome-shaped recesses (1193a, 1193b) configured to face the first and second valve seats (1189a, 1189b), respectively, and define first and second fluid gateways (1194a, 1194b) therebetween. As shown, a generally circular groove (1195) extends proximally from a distal surface of the valve holder (1184), and a distal gasket in the form of a generally circular O-ring (1196) is disposed within the groove (1195) to provide a liquid seal between the valve holder (1184) and a distal end of the chamber (1175).

[0099] As shown, each fluid gateway (1194a, 1194b) is configured to selectively fluid couple the corresponding proximal fluid supply passage (1188a, 1188b) to the distal fluid supply passage (1192) to selectively direct fluid from the corresponding proximal fluid supply passage (1188a, 1188b) through the respective fluid gateway (1194a, 1194b) to the distal fluid supply passage (1192). In this regard, the corresponding portions of each valve (1183a, 1183b) are at least partially disposed within each fluid gateway (1194a, 1194b) to selectively place the corresponding proximal fluid supply passage (1188a, 1188b) in fluid communication and non-communication with the distal fluid supply passage (1192). To that end, the valve retainer (1184) includes first and second valve retaining slots (1197a, 1197b). Each valve (1183a, 1183b) includes a generally frustoconical stem (1198a, 1198b) snugly received within the respective valve retaining slot (1197a, 1197b) and a generally disk-shaped flexible membrane (1199a, 1199b). In some versions, the fluid supply junction (1182) may capture the stem (1198a, 1198b) within the respective valve retaining slot (1197a, 1197b). Each disk-shaped membrane (1199a, 1199b) is flexibly coupled to the corresponding stem (1198a, 1198b) (e.g., via a corresponding integral hinge) such that each membrane (1199a, 1199b) is bendable between its respective open and closed states.

[0100] More specifically, the membrane (1199a) of the first valve (1183a) is bendable between a closed state (Figs. 12A, 12B, 12D) and an open state (Fig. 12C). In the closed state, the membrane (1199a) seals against the first valve seat (1189a) of the fluid supply joint (1182) to prevent fluid from flowing from the first proximal fluid supply flow path (1188a), through the first fluid gateway (1194a), to the distal fluid supply flow path (1192). In the open state, the membrane (1199a) disengages from the first valve seat (1189a) of the fluid supply joint (1182) to allow fluid to flow from the first proximal fluid supply flow path (1188a), through the first fluid gateway (1194a), to the distal fluid supply flow path (1192). Similarly, the membrane (1199b) of the second valve (1183b) is bendable between a closed state (Figs. 12A - 12C) and an open state (Fig. 12D). In the closed state, the membrane (1199b) seals against the second valve seat (1189b) of the fluid supply joint (1182) to prevent fluid from flowing from the second proximal fluid supply flow path (1188b), through the second fluid gateway (1194b), to the distal fluid supply flow path (1192). In the open state, the membrane (1199b) disengages from the second valve seat (1189b) of the fluid supply joint (1182) to allow fluid to flow from the second proximal fluid supply flow path (1188b), through the second fluid gateway (1194b), to the distal fluid supply flow path (1192).

[0101] Each membrane (1199a, 1199b) of the present embodiment is elastically biased to assume its respective closed state and is configured to bend towards its respective open state in response to the application of a threshold downstream force to each membrane (1199a, 1199b), which may be due to the presence of a threshold fluid pressure in the corresponding proximal fluid supply passage (1188a, 1188b). For example, each membrane (1199a, 1199b) may be configured to immediately bend towards its respective open state in response to the fluid pressure in the corresponding proximal fluid supply passage (1188a, 1188b) reaching the threshold fluid pressure and enabling fluid flow in the downstream direction, and may be configured to immediately elastically return to its respective closed state and prevent backflow of fluid in the upstream direction in response to the fluid pressure in the corresponding proximal fluid supply passage (1188a, 1188b) dropping below the threshold fluid pressure. 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) may be configured and operable in accordance with one or more teachings of European Patent No. 1953432 entitled "Fluid Control Valve" granted on April 12, 2017.

[0102] As shown in FIG. 12C, when the membranes (1199a) of the first valves (1183a) are in their respective open states and the membranes (1199b) of the second valves (1183b) are in their respective closed states, the bleb fluid (340) can flow from the first luer fitting (1180a) through the first lumen (1187a) of the first fluid supply tube (1181a), through the first proximal fluid supply passage (1188a) of the fluid supply junction (1182), through the first fluid gateway (1194a), through the distal fluid supply passage (1192) of the valve holder (1184), and into the inner lumen (1145) of the inner cannula (1135) for delivery at the inclined distal end (1144). Due to the closure of the membranes (1199b) of the second valves (1183b), the therapeutic fluid (341) can remain substantially isolated from the bleb fluid (340) within the instrument (1110) during such delivery of the bleb fluid (340).

[0103] As shown in FIG. 12D, when the membranes (1199b) of the second valves (1183b) are in their respective open states and the membranes (1199a) of the first valves (1183a) are in their respective closed states, the therapeutic fluid (341) can flow from the second luer fitting (1180b) through the second lumen (1187b) of the second fluid supply tube (1181b), through the second proximal fluid supply passage (1188b) of the fluid supply junction (1182), through the second fluid gateway (1194b), through the distal fluid supply passage (1192) of the valve holder (1184), and into the inner lumen (1145) of the inner cannula (1135) for delivery at the inclined distal end (1144). Due to the closure of the membranes (1199a) of the first valves (1183a), the bleb fluid (340) can remain substantially isolated from the therapeutic fluid (341) within the instrument (1110) during such delivery of the therapeutic fluid (341).

[0104] The proximal O-ring (1191) may assist in preventing fluid flowing through any of the fluid supply gateways (1194a, 1194b) from leaking proximally from the chamber (1175) of the connection member (1162), and it will be understood that the distal O-ring (1196) may assist in preventing fluid flowing between the distal fluid supply flow path (1192) and the inner lumen (1145) of the inner cannula (1135) from leaking to the side of the chamber (1175) of the connection member (1162).

[0105] In this example, the dish valves (1183a, 1183b) are used, but any other suitable type of valve, such as an umbrella valve, may be used. Other suitable ways of incorporating the valve into the instrument (1100) and / or the system (1000) will be apparent to those skilled in the art in view of the teachings herein. For example, the instrument (1100) may include an integrated valve assembly configured and operable in accordance with at least some of the teachings of U.S. Patent No. 10,226,379, entitled "Method and Apparatus for Subretinal Administration of Therapeutic Agent," issued on March 12, 2019, the disclosure of which is incorporated herein by reference.

[0106] Referring now to FIG. 13, the fluid source assembly (1210) of the present embodiment includes first and second fluid sources in the form of syringes (1212a, 1212b), a syringe cradle (1214), a cradle dock (1216), and a wearable component in the form of a sterilization 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 a lumen (not shown) extending therebetween. Each distal end (1222a, 1222b) includes a first dispensing opening (1226a, 1226b) and a threaded portion (1228a, 1228b) that enables connection of each syringe (1212a, 1212b) to a needle, tube, etc. In some versions, each threaded portion (1228a, 1228b) includes a conventional Luer fitting. In the example shown, the threaded portions (1228a, 1228b) are configured to threadedly engage first and second Luer fittings (1180a, 1180b), respectively, to fluidly couple the respective lumens of the syringes (1212a, 1212b) to corresponding lumens (1187a, 1187b) of supply tubes (1181a, 1181b). In this regard, the lumen of the first syringe (1220a) contains the Bleb fluid (340), and the lumen of the second syringe (1220b) contains the therapeutic fluid (341). Each proximal end (1224a, 1224b) includes a second opening (not shown) configured to receive a corresponding plunger piston (1232a, 1232b). In some versions, the lumen of each syringe (1212a, 1212b) includes a first portion configured to receive a corresponding piston (1232a, 1232b) and a second reduced cross-sectional dimension portion of each proximal end (1224a, 1224b). Each piston (1232a, 1232b) can be selectively advanced and retracted by fluidly coupling the lumen of each syringe (1212a, 1212b) to a pressurized air source, as will be described in more detail below.

[0107] The proximal ends (1224a, 1224b) of each syringe barrel (1220a, 1220b) extend radially outward with respect to the longitudinal axis of the respective syringe (1212a, 1212b) and include flanges (1234a, 1234b) that can function as finger grips, for example, when a user holds the respective syringes (1212a, 1212b). By way of mere example, each syringe (1212a, 1212b) may be constructed and operable in accordance with at least some of the teachings of U.S. Patent No. 10,258,502, entitled "Therapeutic Agent Delivery Device," issued on April 16, 2019, the disclosure of which is incorporated herein by reference.

[0108] The syringe cradle (1214) of the present embodiment includes a cradle body (1240) having a pair of parallel longitudinal channels (1242) (one is shown) configured to selectively hold the respective syringe barrels (1220a, 1220b) to selectively fix the syringes (1212a, 1212b) to the syringe cradle (1214). In this regard, a pair of detents (1244) (one is shown) each extend partially laterally outwardly over the respective channel (1242) to assist in selectively holding the respective syringe barrels (1220a, 1220b) within the respective channels (1242), such as by providing a snap-fit engagement with the respective syringe barrels (1220a, 1220b).

[0109] In the illustrated example, a pair of collars (1250a, 1250b) are disposed at the proximal end of the cradle body (1240) in alignment with respective channels (1242). The collars (1250a, 1250b) enable coupling of respective syringes (1212a, 1212b) with a system having one or more electric components, as will be described in more detail below. Each collar (1250a, 1250b) is used to fix a corresponding portion of a pressure control delivery assembly (1310) (e.g., syringe adapters (1318a, 1318b) described below) to the proximal ends (1224a, 1224b) of the syringes (1212a, 1212b), thereby preventing movement of such portions of the pressure control delivery assembly (1310) relative to their respective syringes (1212a, 1212b). Each collar (1250a, 1250b) may be configured to keep such portions of the pressure control delivery assembly (1310) fixed to their respective syringes (1212a, 1212b) even when pressurizing media is flowing through either syringe (1212a, 1212b) at a fluid pressure of about 20 psi to about 40 psi. Each collar (1250a, 1250b) of the present example includes a generally U-shaped body defined by U-shaped 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), defining a U-shaped cavity sized and configured to receive at least a portion of the flanges (1234a, 1234b) of their respective syringes (1212a, 1212b) and / or corresponding portions of the pressure control delivery assembly (1310) (e.g., corresponding flanges (2370a, 2370b) described below). By way of example only, each collar (1250a, 1250b) may be constructed and operable in accordance with at least some of the teachings of U.S. Patent No. 10,258,502, titled “Therapeutic Agent Delivery Device,” issued Apr. 16, 2019, the disclosure of which is incorporated herein by reference.

[0110] As shown, the grip tab (1258) extends upwardly from the distal end of the cradle body (1240) to assist the operator in manipulating the cradle (1214) by selectively coupling the cradle (1214) to the cradle dock (1216) and / or selectively removing the cradle (1214) from the cradle dock (1216). A coupling member in the form of a plug (1260) extends downwardly from the distal end of the cradle body (1240) to facilitate such selective coupling and removal of the cradle (1214) to / from the cradle dock (1216). In the illustrated example, the plug (1260) includes a pair of laterally opposed bendable beams (1262) (one is shown) configured to provide a snap-fit engagement with a corresponding portion of the cradle dock (1216).

[0111] In this regard, the cradle dock (1216) of the present embodiment includes a generally arch-shaped plate (1270) and a central socket (1272) extending through the arch-shaped plate (1270) configured to selectively receive the plug (1260) and thereby selectively couple the cradle (1214) to the cradle dock (1216). For example, the periphery of the socket (1272) may be configured to provide a snap-fit engagement with the bendable beam (1262) of the plug (1260). Although the plug (1260) and socket (1272) are shown, it will be understood that the cradle (1214) may be selectively coupled to the cradle dock (1216) in any other suitable manner. For example, the cradle (1214) may be selectively coupled to the cradle dock (1216) via a magnetic attraction between a first magnet (not shown) of the cradle (1214) and a second magnet (not shown) of the cradle dock (1216). In addition to or instead of this, the cradle (1214) may be selectively coupled to the cradle dock (1216) via a surface fastener (not shown).

[0112] In the illustrated example, the arch-shaped plate (1270) has a generally concave bottom (1274) contoured to complement the upper region of the operator's wrist, and the arch-shaped plate (1270) can fit snugly around the operator's wrist. To that end, the cradle dock (1216) further includes a pair of opposing slots (1276) configured to receive the wristband (1218), defining a loop sized and configured to receive the operator's wrist, whereby the fluid source assembly (1210) may be secured to the operator's wrist. In this way, the syringes (1212a, 1212b) may be operably attached to the operator's wrist and supported via the wristband (1218). In some versions, the wristband (1218) includes, for example, first and second fasteners (not shown), a strip of a hook and loop fastening mechanism, or other mechanisms configured to selectively couple to each other to close the loop defined by the wristband (1218) and selectively decouple from each other to open the loop defined by the wristband (1218) to assist the operator in donning and removing the wristband (1218). Additionally, or alternatively, the wristband (1218) may include an elastomeric material to facilitate sliding of the wristband (1218) over the operator's knuckles. Various other suitable ways of configuring the wristband (1218) will be apparent to those skilled in the art in view of the teachings herein.

[0113] In some versions, the fluid source assembly (1210) may be fixed to the wrist of the same hand that the operator uses to grip the handle body (1120) of the fluid injection device (1110). Such a configuration can limit the potential movement of the syringes (1212a, 1212b) relative to the device (1110), such as in a direction away from the device (1110). This can minimize the risk of the syringes (1212a, 1212b) pulling on the device (1110) via their respective supply tubes (1181a, 1181b). For example, such a configuration can reduce the device (1110) from bearing the weight of the syringes (1212a, 1212b), 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) may be provided with enough slack to allow for some movement of the device (1110) relative to the fluid source assembly (1210) while the operator is gripping the handle body (1120) with the same hand to which the fluid source assembly (1210) is fixed. For example, this allows for pivoting or other operation of the device (1110) without the syringes (1212a, 1212b) pulling on the device (1110) via their respective supply tubes (1181a, 1181b).

[0114] Referring now to FIGS. 14-15B, the pressure control delivery assembly (1310) of the present embodiment is coupled to a pressurized fluid media source (1314) (FIG. 5) via a fluid media supply tube (1316) and is coupled to first and second syringe adapters (1318a, 1318b) via first and second fluid media delivery tubes (1319a, 1319b), respectively, and includes a fluid selection device (1312). The pressurized fluid media source (1314) may include any suitable pressurized fluid media such as air. Other suitable fluid media that may be used will be apparent to those skilled in the art in view of the teachings herein. The pressurized fluid media source (1314) may be operably coupled to a fluid pump (not shown) operable to pressurize the fluid media. In some versions, the pressurized fluid media source (1314) may also be operably coupled to a pressure regulator (not shown) operable to adjust the fluid pressure of the pressurized fluid media output from the pump. The various suitable forms that such a pump and / or regulator may take will be apparent to those skilled in the art in view of the teachings herein. By way of example only, such a pump and / or regulator may be configured and operable in accordance with at least some of the teachings of U.S. Patent No. 10,258,502, entitled "Therapeutic Agent Delivery Device," issued April 16, 2019, the disclosure of which is incorporated herein by reference.

[0115] The fluid selection device (1312) of this example includes a rigid manifold (1320) in a generally pack shape, a valve assembly (1322), and a selector knob (1324). In the illustrated example, the manifold (1320) is formed from a first and a second shell (e.g., halves) (1320a, 1320b) fixedly coupled to each other along the longitudinal centerline of the manifold (1320) via a plurality of fasteners in the form of screws (1326) such that the shells (1320a, 1320b) collectively define the manifold (1320). The shells (1320a, 1320b) may each be manufactured by three-dimensional printing, injection molding, investment casting, machining, and / or any other suitable manufacturing technique and then assembled together to form the manifold (1320). It will be understood that the manifold (1320) may be formed in any other suitable manner. For example, the shells (1320a, 1320b) may be integrally formed with each other as a single (e.g., monolithic) component for defining the manifold (1320) such that the corresponding pair of engagement mechanisms may be omitted.

[0116] As shown, the manifold (1320) defines an internal cavity (1330) configured to at least partially receive various components of the valve assembly (1322), the fluid media supply tube (1316), the fluid media delivery tubes (1319a, 1319b), and the selector knob (1324). In this regard, the manifold (1320) of the present example also includes a proximal bore (1331) configured to receive a portion of the fluid media supply tube (1316) and a distal bore (1332) configured to receive a portion of the fluid media delivery tubes (1319a, 1319b), whereby the fluid media supply tube (1316) may extend from the internal cavity (1330) via the proximal bore (1331), and the fluid media delivery tubes (1319a, 1319b) may extend from the internal cavity (1330) via the distal bore (1332). In the illustrated example, a plurality of internal partitions (1334) extend partially across the internal cavity (1330) and are spaced apart from each other to receive corresponding portions of the valve assembly (1322), thereby firmly holding the valve assembly (1322) within the internal cavity (1330). The manifold (1320) of the present example further includes an upper bore (1336) configured to rotatably receive the lower portion of the selector knob (1324).

[0117] The valve assembly (1322) of this embodiment is in the form of a three-way valve. The valve assembly (1322) of this 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) pivotally coupled to the valve body (1340) for selectively disposing the inlet port (1342) in a fluid communication state with each of the outlet ports (1344a, 1344b). In this regard, the flow selector (1346) can be pivoted 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) in which the inlet port (1342) is fluidly coupled to the first outlet port (1344a) and fluidly isolated from the second outlet port (1344b), and a second open state (FIG. 15B) in which the inlet port (1342) is fluidly coupled 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) such that an operator can pivot the flow selector (1346) between the open and closed states by rotation of the selector knob (1324).

[0118] In the illustrated example, the fluid medium supply tube (1316) extends between an open proximal end (1350) and an open distal end (1351) and defines a lumen (1352) therebetween for conducting air (or other fluid medium). The open proximal end (1350) is fluidly connected to a pressurized fluid medium source (1314) via a pneumatic coupling (1353), and the open distal end (1351) is fluidly connected to the inlet port (1342) via a pneumatic coupling (1354). In the illustrated example, the fluid medium supply tube (1316) extends through the proximal bore (1331) of the manifold (1320) such that the open distal end (1351) is disposed within the internal cavity (1330) of the manifold (1320) for connection to the inlet port (1342), and the open proximal end (1350) is disposed outside the manifold (1320) for connection to the pressurized fluid medium source (1314).

[0119] Each fluid media delivery tube (1319a, 1319b) extends between an open proximal end (1355a, 1355b) and an open distal end (1356a, 1356b), and defines a lumen (1357a, 1357b) that extends therebetween for conducting fluid. As will be described in more detail below, each open proximal end (1355a, 1355b) is fluidly connected to a respective outlet port (1344a, 1344b) via a corresponding pneumatic fitting (1358a, 1358b), and each open distal end (1356a, 1356b) is fluidly connected to a respective syringe adapter (1318a, 1318b). In the illustrated example, both fluid media delivery tubes (1319a, 1319b) extend through the distal bore (1332) of the manifold (1320), the open proximal ends (1355a, 1355b) are disposed within the internal cavity (1330) of the manifold (1320) for coupling to the respective outlet ports (1344a, 1344b), and the open distal ends (1356a, 1356b) are disposed external to the manifold (1320) for coupling to the respective syringe adapters (1318a, 1318b). In the illustrated example, portions of the fluid media delivery tubes (1319a, 1319b) extend parallel to each other and are collectively wound around a braided sleeve (1359).

[0120] 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 return connection mechanism (1364a, 1364b) adapted to connect to a corresponding tube (1365a, 1365b) adapted to connect to a corresponding fluid media delivery tube (1319a, 1319b). Each distal end (1362a, 1362b) comprises a tubular member (1366a, 1366b) having an annular recess (not shown) for receiving 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 a second opening of a corresponding syringe barrel (1220a, 1220b), and each O-ring (1368a, 1368b) is configured to provide a liquid-tight seal between the lumen of a corresponding syringe (1212a, 1212b) and a respective syringe adapter (1318a, 1318b) to prevent leakage of fluid pressure from the second opening of the corresponding syringe barrel (1220a, 1220b). A lumen (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 this example, each syringe adapter (1318a, 1318b) is a single integral body, but in other examples may include a plurality of parts coupled to each other. Various other suitable ways of constructing the syringe adapter (1318a, 1318b) will be apparent to those skilled in the art in view of the teachings herein. By way of example only, each syringe adapter (1318a, 1318b) may be constructed and operable in accordance with at least some of the teachings of U.S. Patent No. 10,258,502, entitled "Therapeutic Agent Delivery Device," issued April 16, 2019, the disclosure of which is incorporated herein by reference.

[0121] As will be described in more detail below, the proximal ends (1360a, 1360b) of the syringe adapters (1318a, 1318b) may each be selectively coupled to a pressurized fluid media source (1314), and the distal ends (1362a, 1362b) of the syringe adapters (1318a, 1318b) may each be received in a second opening of the corresponding syringe (1212a, 1212b). Thus, pressurized air (or other fluid media) may selectively flow through the lumen of the first syringe (1212a) via the first adapter (1318a) proximal to the piston (1232a), advancing the piston (1232a) within the first syringe (1212a), thereby dispensing fluid from the first syringe (1212a). Similarly, pressurized air (or other fluid media) may selectively flow through the lumen of the second syringe (1212b) via the second adapter (1318b) proximal to the piston (1232b), advancing the piston (1232b) within the second syringe (1212b), thereby dispensing fluid from the second syringe (1212b). In some cases, either adapter (1318a, 1318b) may be used to selectively cause suction to flow through the lumen of the corresponding syringe (1212a, 1212b) proximal to the respective piston (1232a, 1232b), retracting the respective piston (1232a, 1232b) within the corresponding syringe (1212a, 1212b), thereby drawing fluid into the corresponding syringe (1212a, 1212b).

[0122] When the flow selector (1346) of the valve assembly (1322) is in the first open state shown in FIG. 15A, pressurized air (or other fluid medium) flows from the pressurized fluid medium source (1314), through the lumen (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 lumen (1357a) of the first fluid medium delivery tube (1319a), through the lumen of the first adapter (1318a), and into the lumen of the first syringe (1212a) to advance the piston (1232a), thereby distributing the brachy fluid (340) from the first syringe (1212a) to the first luer fitting (1180a). The brachy fluid (340) may then move downstream along the aforementioned flow path for delivery at the angled distal end (1144) of the inner cannula (1135) of the fluid injection device (1110). In this regard, the advancement of the piston (1232a) may cause the fluid pressure in the first proximal fluid supply flow path (1188a) of the device (1110) to reach the aforementioned threshold fluid pressure, whereby the first membrane (1199a) of the first disc valve (1183a) immediately bends towards its respective open state, allowing the downstream flow of the brachy fluid (340) through the first fluid gateway (1194a). Prevention of such advancement of the piston (1232a) may cause the fluid pressure in the first proximal fluid supply flow path (1188a) of the device (1110) to drop below the aforementioned threshold fluid pressure, whereby the first membrane (1199a) of the first disc valve (1183a) immediately elastically returns to its respective closed state, stopping the downstream flow of the brachy fluid (340) through the first fluid gateway (1194a) and simultaneously preventing upstream backflow.

[0123] When the flow selector (1346) of the valve assembly (1322) is in the second open state shown in FIG. 15B, pressurized air (or other fluid medium) flows from the pressurized fluid medium source (1314), through the lumen (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 lumen (1357b) of the second fluid medium delivery tube (1319b), through the lumen of the second adapter (1318b), and into the lumen of the second syringe (1212b) to advance the piston (1232b), thereby distributing the therapeutic fluid (341) from the second syringe (1212b) to the second luer fitting (1180b). The therapeutic fluid (341) may then move downstream along the flow path described above for delivery at the angled distal end (1144) of the inner cannula (1135) of the fluid injection device (1110). In this regard, the advancement of the piston (1232b) may cause the fluid pressure in the second proximal fluid supply flow path (1188b) of the device (1110) to reach the aforementioned threshold fluid pressure, such that the second membrane (1199b) of the second disc valve (1183b) can immediately bend towards their respective open states to allow the flow of the therapeutic fluid (341) in the downstream direction through the second fluid gateway (1194b). Prevention of such advancement of the piston (1232b) may cause the fluid pressure in the second proximal fluid supply flow path (1188b) of the device (1110) to drop below the aforementioned threshold fluid pressure, whereby the second membrane (1199b) of the second disc valve (1183b) immediately elastically returns to their respective closed states, stopping the flow of the therapeutic fluid (341) in the downstream direction through the second fluid gateway (1194b) and simultaneously preventing upstream backflow.

[0124] The pressure control delivery assembly (1310) may be understood to enable rapid switching during the advancement of the pistons (1232a, 1232b) and thus the pumping of fluid (340, 341) into the corresponding fluid supply tubes (1181a, 1181b) for delivery at the angled distal end (1144) of the inner cannula (1135). It may also be understood that the fluid selection device (1312) of the pressure control delivery assembly (1310) may be disposed remotely with respect to the syringes (1212a, 1212b). For example, the fluid source assembly (1210) including the syringes (1212a, 1212b) may be secured to the operator's wrist as described above, but the fluid selection device (1312) may be disposed at another location (e.g., out of reach of the operator) in the sterile environment where the procedure is being performed, such as on a Mayo stand or at the technician's hand, and the fluid media delivery tubes (1319a, 1319b) and braided sleeve (1359) are of a length sufficient to accommodate the necessary movement of the operator with respect to the fluid selection device (1312). In this way, the technician may operate the selector knob (1324) to rapidly switch the delivery of fluid (340, 341) while the operator is focused on maintaining the angled distal end (1144) of the inner cannula (1135) in the subretinal space. In other words, such remote placement of the fluid selection device (1312) with respect to the syringes (1212a, 1212b) may enable a person other than the operator to control the delivery of fluid (340, 341) at the angled distal end (1144). Nevertheless, in some scenarios, the fluid selection device (1312) may be disposed within reach of the operator so that the operator can control the delivery of fluid (340, 341) at the angled distal end (1144). For example, the fluid selection device (1312) may be secured to the operator (e.g., on 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 fluid media delivery tubes (1319a, 1319b) and the braided sleeve (1359) may be relatively short in length (e.g., less than or equal to the length of the operator's forearm), and the fluid media supply tube (1316) may be of a length sufficient to accommodate the required movement of the operator relative to the pressurized fluid media source (1314).

[0125] Thus, it is to be understood that a system (1000) including a fluid injection device (1110), a fluid source assembly (1210), and a pressure control delivery assembly (1310) can be used to perform subretinal delivery of the bubble fluid (340) and the therapeutic agent (341) described above with respect to FIGS. 3-4J. Other suitable methods in which a system (1000) including a fluid injection device (1110), a fluid source assembly (1210), and / or a pressure control delivery assembly (1310) can be used will be apparent to those skilled in the art in view of the teachings herein.

[0126] B. Second Example of a Transvitreal Subretinal Injection System

[0127] FIG. 16 shows an example of a system (2000) for delivering one or more fluids during a procedure for treating an eye condition such as subretinal delivery of the above-described therapeutic agent (341), including a fluid injection device (2110), a fluid source assembly (2210), and a pressure-controlled delivery assembly (2310). The system (2000) can be configured and operable in the same manner as the above-described system (1000), unless otherwise described below. The fluid injection device (2110), the fluid source assembly (2210), and the pressure-controlled delivery assembly (2310) will be described below in relation to the system (2000), but it will be understood that any of the fluid injection device (2110), the fluid source assembly (2210), and / or the pressure-controlled delivery assembly (2310) can be easily incorporated into the above-described system (1000). For example, the fluid injection device (2110) can be easily incorporated into the system (1000) in place of the fluid injection device (1110), the fluid source assembly (2210) can be easily incorporated into the system (1000) in place of the fluid source assembly (1210), and / or the pressure-controlled delivery assembly (2310) can be easily incorporated into the system (1000) in place of the pressure-controlled delivery assembly (1310).

[0128] Continuing to refer to FIG. 16 and primarily referring to FIGS. 17 - 19, the fluid injection device (2110) can be configured and operable in the same manner as the above-described device (1110), unless otherwise described in other embodiments 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).

[0129] 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 further include a strain relief (not shown) similar to the strain relief (1122). In the illustrated example, the handle body (2120) is formed from a first and a second shell (e.g., halves) (2120a, 2120b) fixedly coupled to each other along the longitudinal centerline of the handle body (2120) via corresponding pairs of engagement mechanisms (e.g., detents and recesses for interlocking) such that the shells (2120a, 2120b) collectively define the handle body (2120).

[0130] As shown, the handle body (2120) defines an internal cavity (2124) configured to at least partially house 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 this example also includes a proximal bore (2125) configured to receive a portion of the fluid supply assembly (2114) and a distal bore (2126) configured to receive a portion of the fluid delivery assembly (2116), whereby the fluid supply assembly (2114) may extend from the internal cavity (2124) via the proximal bore (2125) and the fluid delivery assembly (2116) may extend from the internal cavity (2124) via the distal bore (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 bore (2129) configured to receive a portion of the fluid delivery assembly (2116) such that the cannula hub (2121) may support the fluid delivery assembly (2116) within the internal cavity (2124).

[0131] The handle body (2120) of the present example also extends laterally across an internal cavity (2124) and is configured to be pivotally received by a corresponding portion of the actuating assembly (2118), as will be described in more detail below, and includes a pivot pin (2130) and an upper slot (2131) disposed generally above the pivot pin (2130) and configured to expose a corresponding portion of the actuating assembly (2118) outside the handle body (2120). In the illustrated example, the handle body (2120) further includes a plurality (e.g., four) of longitudinal rails (2132) (two are shown) configured to slidably support a corresponding portion of the actuating assembly (2118).

[0132] The fluid delivery assembly (2116) of the present embodiment includes an outer cannula (2134) and an inner cannula (2135) similar to the outer cannula (1134) and the inner cannula (1135) described above, respectively.

[0133] The actuating assembly (2118) of this embodiment includes a pivotable scroll wheel (2150), a translatable cannula slider (2151), and a translatable cannula support tube (2152) configured to cooperate with each other to drive the translation of the inner cannula (2135) relative to the outer cannula (2134). In the illustrated example, the scroll wheel (2150) is pivotally connected to the handle body (2120) and includes a generally arched grip portion (2153) and a pair of laterally opposed arms (2154) extending generally downwardly from the grip portion (2153). The scroll wheel (2150) of this example also includes a pair of pivot bores (2155) each configured to extend laterally through a lower portion of a respective arm (2154) and to pivotally receive a pivot pin (2130) of the handle body (2120) to pivotally couple the scroll wheel (2150) to the handle body (2120). The scroll wheel (2150) may be pivotable about a pivot axis defined by the pivot pin (2130) and the pivot bores (2155) between at least one operating state, such as a non-operating state and a fully operating state. In this regard, the grip portion (2153) may be at least partially exposed outside the handle body (2120) via an upper slot (2131) to enable, for example, an operator's thumb to access and operate the grip portion (2153) between the non-operating state and the fully operating state.

[0134] In the illustrated example, the scroll wheel (2150) also includes a pair of parallel flanges (2156) having opposed generally flat cam surfaces (2157) spaced apart from each other and defining a socket (2158) configured to extend generally downwardly from the grip portion (2153) between the arms (2154) and receive a portion of the cannula slider (2151).

[0135] In this regard, the cannula-less red (2151) of this example is movably connected in parallel to the handle body (2120) and includes a thread housing (2160). As best shown in FIG. 18, the thread housing (2160) includes a drum (2163) and a yoke (2164) having a generally bulbous distal hitch (2165) that extends distally from the drum (2163) and extends generally upwardly to be received within a socket (2158) of the scroll wheel (2150). In the illustrated example, the hitch (2165) has a generally C-shaped cam surface (2166) configured to be cam-engaged by one or both planar cam surfaces (2157) of the scroll wheel (2150) to convert pivotal movement of the scroll wheel (2150) into translational movement of the cannula-less red (2151), such that the cannula-less red (2151) can be longitudinally translatable between a proximal position and a distal position in response to pivotal movement of the scroll wheel (2150) between a non-operating state and a fully-operating state. The drum (2163) of this example includes a plurality (e.g., four) of lateral protrusions (2167) (two are shown) configured to be slidably received between corresponding pairs of longitudinal rails (2132) of the handle body (2120) such that interaction between the rails (2132) and the protrusions (2167) can induce longitudinal translational movement of the cannula-less red (2151) between a proximal position and a distal position during pivotal movement of the scroll wheel (2150) between a non-operating state and a fully-operating state.

[0136] As shown, the yoke (2164) of the thread housing (2160) also includes a central bore (2168) configured to securely receive the cannula support tube (2152) and fix the cannula support tube (2152) against movement relative to the thread housing (2160), such that the cannula support tube (2152) can be translationally movable longitudinally along with the cannula thread (2151). In this regard, the central bore (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), providing an interference fit therebetween. In the illustrated example, the proximal end of the outer cannula (2134) is disposed distal to the central bore (2168). The drum (2163) of the thread housing (2160) also includes a chamber (2169) disposed proximal to the central bore (2168) and configured to securely hold at least a portion of the fluid supply assembly (2114). In this regard, the drum (2163) includes a pair of laterally opposed bores (2176) (one shown) configured to selectively receive retaining pins (2177) for holding various components of the fluid supply assembly (2114) within the chamber (2169).

[0137] In the illustrated example, the cannula support tube (2152) is slidably received within the outer cannula (2134) and is configured to securely receive the inner cannula (2135) such that the inner cannula (2135) can be translationally movable longitudinally along with the cannula support tube (2152) and the cannula thread (2151), fixing the inner cannula (2135) against movement relative to the cannula support tube (2152) (and thus relative to the connection member (2162)).

[0138] The fluid supply assembly (2114) of this embodiment includes the above-described first and second luer connectors (2180a, 2180b), first and second fluid supply tubes (2181a, 2181b), a fluid supply joint (2182), first and second self-actuating check valves (2183a, 2183b), a valve retainer (2184), a substantially oval O-ring (2191), and a substantially circular O-ring (2196), which are similar to the first and second fluid supply tubes (1181a, 1181b), fluid supply joint (1182), first and second self-actuating check valves (1183a, 1183b), valve retainer (1184), substantially oval O-ring (1191), and substantially circular O-ring (1196) of the first and second luer connectors (1180a, 1180b).

[0139] As shown, the fluid supply joint (2182) and the valve retainer (2184) are each firmly held within a chamber (2169) of a threaded housing (2160) of the actuating assembly (2118). More specifically, a retaining pin (2177) (FIG. 17) captures the fluid supply joint (2182) and the valve retainer (2184) within the chamber (2169). The O-ring (2191) provides a liquid seal between the fluid supply joint (2182) and the side surface of the chamber (2169), and the O-ring (2196) provides a liquid seal between the valve retainer (2184) and the distal end of the chamber (2169). Thus, rather than being housed within a connecting member firmly held within the chamber (2169) of the threaded housing (2160), the various components of the fluid supply assembly (2114) may be directly and firmly held within the chamber (2169) of the threaded housing (2160).

[0140] Referring now to FIGS. 20 - 23, the fluid source assembly (2210) may be configured and operable in a manner similar to the fluid source assembly (1210) described above, except as specifically described below. In this regard, the fluid source assembly (2210) of the present embodiment includes first and second fluid sources in the form of syringes (2212a, 2212b), a syringe cradle (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 a lumen (not shown) extending therebetween. Each distal end (2222a, 2222b) includes a first dispensing opening (2226a, 2226b) and a threaded portion (2228a, 2228b) that enables connection of each syringe (2212a, 2212b) to a needle, tube, etc. In the illustrated example, the threaded portions (2228a, 2228b) are configured to threadedly engage first and second luer fittings (2180a, 2180b) to fluidly couple the respective lumens of the syringes (2212a, 2212b) to corresponding lumens of supply tubes (2181a, 2181b). In this regard, the lumen of the first syringe (2220a) contains the blub fluid (340), and the lumen of the second syringe (2220b) contains the therapeutic fluid (341). Each proximal end (2224a, 2224b) includes a second opening (2230a, 2230b) configured to receive a corresponding plunger piston (2232a, 2232b). The proximal ends (2224a, 2224b) of each syringe barrel (2220a, 2220b) extend radially outwardly with respect to the longitudinal axis of the respective syringe (2212a, 2212b) and include flanges (2234a, 2234b) that may function as finger grips, for example, when a user holds the respective syringe (2212a, 2212b).

[0141] The syringe cradle (2214) of the present embodiment includes a cradle body (2240) having a pair of parallel longitudinal sheaths (2241a, 2241b) that define respective bores (2242a, 2242b) configured to selectively hold respective syringe barrels (2220a, 2220b) to selectively fix the syringes (2212a, 2212b) to the syringe cradle (2214). In this regard, each bore (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 respective syringe barrel (2220a, 2220b). In the illustrated example, each sheath (2241a, 2241b) includes respective elongated slots (2243a, 2243b) to enable visual observation of the respective syringe barrels (2220a, 2220b). More specifically, the 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 the lateral elongated slot (2243b) extends through the lateral outside of the second sheath (2241b) to enable visual observation of the second syringe barrel (2220b) passing therethrough.

[0142] In this regard, the cradle body (2240) of this example further has a central body portion (2244) that extends between the sheaths (2241a, 2241b) and defines an illumination chamber (2245) that opens into the second bore (2242b) through a side opening (2246). The chandelier port (2247) extends through the proximal wall of the central body portion (2244) to the illumination chamber (2245) and firmly holds a chandelier socket (2248) sized and configured to selectively receive a chandelier such as a chandelier of an optical fiber (2249), enabling the illumination end of the chandelier (2249) to be disposed and / or illuminated within the illumination chamber (2245). The light emitted by the chandelier (2249) may enter the second bore (2242b) from the illumination chamber (2245) through the side opening (2246), whereby it can be understood that the second syringe barrel (2220b) can be illuminated. Such illumination of the second syringe barrel (2220b) may be visually observed through a laterally elongated slot (2243b). In this way, the chandelier light (2249) may be configured to provide backlighting for the second syringe barrel (2220b), which can assist the operator in determining the amount of therapeutic agent (341) remaining in the lumen of the second syringe (2220b) and / or the amount of therapeutic agent (341) dispensed from the first opening (2226b) of the second syringe (2220b). The chandelier socket (2248) is described for selectively receiving the chandelier (2249), but in some other versions, the illumination end of the chandelier (2249) may be permanently disposed within the illumination chamber (2245) and the chandelier (2249) may be permanently coupled to the cradle body (2240). In addition to, or alternatively to, this, the chandelier (2249) may include a light source such as a light-emitting diode (LED) disposed within the illumination chamber (2245).

[0143] In the illustrated example, a pair of collars (2250a, 2250b) are disposed at the proximal end of the cradle body (2240) in alignment with their respective bores (2242a, 2242b). The collars (2250a, 2250b) enable coupling of their respective syringes (2212a, 2212b) to a system having one or more electric components, as will be described in more detail below. Each collar (2250a, 2250b) is used to secure the corresponding portion of the pressure control delivery assembly (2310) (e.g., syringe adapters (2318a, 2318b) described below) to the proximal ends (2224a, 2224b) of the syringes (2212a, 2212b), thereby preventing movement of such portions of the pressure control delivery assembly (2310) relative to their respective syringes (2212a, 2212b). In this regard, each collar (2250a, 2250b) defines respective proximally facing recesses (2251a, 2251b) sized and configured to receive at least a portion of the flanges (2234a, 2234b) of their respective syringes (2212a, 2212b) and / or the corresponding portions of the pressure control delivery assembly (2310) (e.g., corresponding flanges (2370a, 2370b) described below). In the illustrated example, a pair of retaining tabs (2253a, 2253b) are configured to sandwich the respective portions of the pressure control delivery assembly (2310) against the flanges (2234a, 2234b) of their respective syringes (2212a, 2212b) within the recesses (2251a, 2251b) of their respective collars (2250a, 2250b). In the illustrated example, the retaining tabs (2253a, 2253b) are provided on respective bendable beams (2255a, 2255b) that extend along the bottoms of their respective collars (2250a, 2250b). In other versions, the bendable beams (2255a, 2255b) may extend along the sides (e.g., laterally outward) of their respective collars (2250a, 2250b).Each recess (2251a, 2251b) of the present embodiment includes at least one corresponding key groove (2257a, 2257b), and at least one key groove (2257a) of the first recess (2251a) has a unique configuration (e.g., size, shape, and / or angular position) with respect to at least one key groove (2257b) of the second recess (2251b), the purpose of which will be described later.

[0144] As shown in the illustration, a coupling member in the form of a magnet (2260) is provided on the underside of a cradle body (1240) that provides a magnetic attraction force to a magnetic cuff (2218) to facilitate selective coupling and removal of the cradle (2214) to and from the magnetic cuff (2218). In this regard, the magnetic cuff (2218) of the present embodiment includes one or more iron elements (e.g., iron metal shavings embedded in the cuff material, a single thin metal sheet embedded in the cuff material, etc.) that provide a magnetic attraction force with the magnet (2260). In some other versions, the magnetic cuff (2218) includes an array of magnetic elements that provide magnetic attraction with the magnet (2260). Various suitable features and configurations that can be incorporated into the magnetic cuff (2218) to provide a magnetic attraction force with the magnet (2260) will be apparent to those skilled in the art in view of the teachings herein. The magnetic cuff (2218) defines a loop sized and configured to receive an operator's wrist, thereby securing the fluid source assembly (2210) to the operator's wrist. In this way, the syringes (2212a, 2212b) can be operably attached to the operator's wrist and thereby supported via the magnetic cuff (2218). In some versions, the magnetic cuff (2218) includes, for example, first and second fasteners (not shown), a strip of a hook-and-loop fastening mechanism, or other mechanisms configured to selectively couple to each other to close the loop defined by the magnetic cuff (2218) and selectively separate from each other to open the loop defined by the magnetic cuff (2218) to assist the operator in attaching and detaching the magnetic cuff (2218). In addition to or instead of this, the magnetic cuff (2218) may include an elastomeric material to facilitate sliding of the magnetic cuff (2218) over the operator's knuckles. Various other suitable ways in which the magnetic cuff (2218) can be configured will be apparent to those skilled in the art in view of the teachings herein.

[0145] Referring now to FIG. 24, the pressure control delivery assembly (2310) may be similar to the above-described pressure control delivery assembly (1310), except where otherwise described below. In this regard, the pressure control delivery assembly (2310) of the present embodiment includes a pressurized fluid medium source (2314) (FIG. 16) via a fluid medium supply tube (2316), and a fluid selector device (2312) coupled to first and second syringe adapters (2318a, 2318b) via first and second fluid medium delivery tubes (2319a, 2319b), respectively.

[0146] The fluid selector device (2312) of this example includes a generally pack-shaped rigid manifold (2320), a valve assembly (2322), and a selector knob (2324). In the illustrated example, the manifold (2320) is formed from first and second shells (e.g., halves) (2320a, 2320b) fixedly coupled to each other along the longitudinal centerline of the manifold (2320) via a plurality of fasteners in the form of screws (2326) such that the shells (2320a, 2320b) collectively define the manifold (2320).

[0147] As shown in the figure, the manifold (2320) defines an internal cavity (2330) 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 selector knob (2324). In this regard, the manifold (2320) of this example also includes a proximal bore (2331) configured to receive a portion of the fluid medium supply tube (2316) and a distal bore (2332) configured to receive a portion of the fluid medium delivery tubes (2319a, 2319b), whereby the fluid medium supply tube (2316) may extend from the internal cavity (2330) through the proximal bore (2331), and the fluid medium delivery tubes (2319a, 1319b) may extend from the internal cavity (2330) through the distal bore (2332). In the illustrated example, a plurality of internal partitions (2334) extend partially across the internal cavity (2330) and are spaced apart from each other to receive corresponding portions of the valve assembly (2322), thereby firmly holding the valve assembly (2322) within the internal cavity (2330). The manifold (2320) of this example further includes an upper bore (2336) configured to rotatably receive the lower portion of the selector knob (2324).

[0148] The valve assembly (2322) of this embodiment is in the form of a three-way valve. The valve assembly (2322) of this 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 positioning the inlet port (2342) in fluid communication and fluid communication disconnection with each of the outlet ports (2344a, 2344b) in the same manner as described above in connection with FIGS. 15A - 15B.

[0149] In the illustrated example, the fluid media supply tube (2316) extends between an open proximal end (2350) and an open distal end (2351), and defines a lumen (2352) extending therebetween for conducting air (or other fluid media). The open proximal end (2350) is fluidly connected to a pressurized fluid media source (2314) via a pneumatic fitting (2353), and the open distal end (2351) is fluidly connected to an inlet port (2342) via a pneumatic fitting (2354).

[0150] Each fluid media delivery tube (2319a, 1319b) extends between an open proximal end (2355a, 1355b) and an open distal end (2356a, 1356b), and defines a lumen (2357a, 1357b) extending therebetween for conducting fluid. As will be described in more detail below, each open proximal end (2355a, 1355b) is fluidly connected to a respective outlet port (2344a, 1344b) via a corresponding pneumatic fitting (2358a, 1358b), and each open distal end (2356a, 1356b) is fluidly connected to a respective syringe adapter (2318a, 1318b).

[0151] 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 mechanism (2364a, 2364b) adapted to connect to a corresponding fluid media delivery tube (2319a, 2319b). Each distal end (2362a, 2362b) comprises a tubular member (2366a, 2366b) having an annular recess (not shown) for receiving 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 a second opening of a corresponding syringe barrel (2220a, 2220b), and each O-ring (2368a, 2368b) is configured to provide a liquid seal between the lumen of a corresponding syringe (2212a, 2212b) and its respective syringe adapter (2318a, 2318b) to prevent leakage of fluid pressure from the second opening of the corresponding syringe barrel (2220a, 2220b). A lumen (not shown) extends between each proximal end (2360a, 2360b) and each distal end (2362a, 2362b). A flange (2370a, 2370b) is disposed between the proximal end (2360a, 2360b) and the distal end (2362a, 2362b) of each syringe adapter (2318a, 2318b).

[0152] As described in more detail above in connection with FIGS. 14-15B, the proximal ends (2360a, 2360b) of the syringe adapters (2318a, 2318b) may each be selectively coupled to a pressurized fluid medium source (2314), and the distal ends (2362a, 2362b) of the syringe adapters (2318a, 2318b) may each be received in a second opening of a 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), and 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 within at least one keyway (2257a) of the first recess (2251a), but not within at least one keyway (2257b) of the second recess (2251b). At least one key (2371b) of the second flange (2370b) is configured to be received within at least one keyway (2257b) of the second recess (2251b), but not within 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) may cooperate with each other to prevent the distal ends (2362a, 2362b) of the syringe adapters (2318a, 2318b) from being inadvertently received in the second openings of the wrong syringes (2212a, 2212b), thereby ensuring that pressurized air (or other fluid medium) is selectively circulated through the lumen of the first syringe (2212a) via the first adapter (2318a), and that pressurized air (or other fluid medium) is selectively circulated through the lumen of the second syringe (2212b) via the second adapter (2318b).

[0153] Accordingly, it is to be understood that a system (2000) comprising a fluid injection device (2110), a fluid source assembly (2210), and a pressure-controlled delivery assembly (2310) can be used to perform subretinal delivery of the bleb fluid (340) and therapeutic agent (341) described above with respect to FIGS. 3-4J. Other suitable methods in which a system (2000) comprising a fluid injection device (2110), a fluid source assembly (2210), and / or a pressure-controlled delivery assembly (2310) can be used will be apparent to those skilled in the art in view of the teachings herein.

[0154] Systems (1000, 2000) comprising a fluid injection device (1110, 2110), a fluid source assembly (1210, 2210), and a pressure-controlled delivery assembly (1310, 2310) have been described in connection with delivery of bleb fluid (340) and therapeutic agent (341) from a transvitreal transretinal approach to the subretinal space, but it will be understood that the various components of any of the systems (1000, 2000) can be used for delivery of bleb fluid (340) and / or therapeutic agent (341) to the subretinal space from any other suitable type of approach. In some versions, any fluid supply assembly (1114, 2114) can be readily incorporated into a fluid injection device configured to deliver bleb fluid (340) and / or therapeutic agent (341) to the subretinal space from a suprachoroidal approach, for example, by selectively fluidly coupling first and second conduits to a needle of such a fluid injection device to supply bleb fluid (340) and therapeutic agent (341) to the needle, respectively. For example, any fluid supply assembly (1114, 2114) can be readily incorporated into a fluid injection device configured and operable in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, entitled "Apparatus and Method to Form Entry Bleb for Subretinal Delivery of Therapeutic Agent," issued May 12, 2020, the disclosure of which is incorporated herein by reference.

[0155] IV. Examples of Combinations

[0156] The following examples relate to various non-exhaustive ways in which the teachings of this specification may be combined or applied. It should be understood that the following examples are not intended to limit the scope of the claims that may be presented at any time in this application or in subsequent applications of this application. No waiver is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of this specification may be arranged and applied in many other ways. Also, it is contemplated that some variations may omit certain features mentioned in the following examples. Thus, none of the aspects or features mentioned below should be considered important unless so explicitly indicated as such by the inventors or by successors in interest to the inventors at a later date. If claims containing additional features other than those mentioned below are presented in this application or in subsequent applications related to this application, those additional features shall not be presumed to have been added for any reason related to patentability.

[0157] Example 1

[0158] An apparatus comprising: (a) a body; (b) an outer cannula extending distally from the body along a longitudinal axis and fixedly secured to the body, the outer cannula having (i) a proximal portion having a first cross-sectional dimension and (ii) a distal portion having at least one second cross-sectional dimension smaller than the first cross-sectional dimension, the distal portion being configured to guide the cylindrical proximal portion into a trocar port for advancing the outer cannula into a patient's eye; and (c) an inner cannula extending along the longitudinal axis and slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, the inner cannula having (i) an open proximal end, (ii) an open distal end configured to puncture the retina of the eye, and (iii) a lumen extending between the open proximal end and the open distal end, the lumen being configured to allow at least one fluid to flow from the open proximal end to the open distal end for delivering at least one fluid to the subretinal region of the eye.

[0159] Example 2

[0160] The device according to Example 1, wherein the distal portion tapers radially inwards in the distal direction.

[0161] Example 3

[0162] The device according to Example 1, wherein the distal portion curves radially inwards in the distal direction.

[0163] Example 4

[0164] The device according to any one of Examples 1 to 3, wherein the proximal portion is substantially cylindrical.

[0165] Example 5

[0166] The device according to Example 4, wherein the distal portion is substantially frustoconical.

[0167] Example 6

[0168] The device according to any one of Examples 1 to 5, wherein the proximal portion defines a proximal opening and the distal portion defines a distal opening that is smaller than the proximal opening.

[0169] Example 7

[0170] The device according to Example 6, wherein the distal opening is configured to maintain centering of the inner cannula relative to the outer cannula during longitudinal translation of the inner cannula relative to the outer cannula.

[0171] Example 8

[0172] The device according to any one of Examples 1 to 7, wherein the open distal end is inclined.

[0173] Example 9

[0174] The device according to Example 8, wherein the open distal end is oriented at an angle of about 45 degrees relative to the longitudinal axis.

[0175] Example 10

[0176] The device according to any one of Examples 1 to 9, wherein the outer cannula is rigid.

[0177] Example 11

[0178] The device according to any one of Examples 1 to 10, wherein the outer cannula contains a metallic material.

[0179] Example 12

[0180] The device according to Example 11, wherein the outer cannula contains surgical stainless steel.

[0181] Example 13

[0182] The device according to any one of Examples 1 to 12, wherein the inner cannula is flexible.

[0183] Example 14

[0184] The device according to any one of Examples 1 to 13, wherein the inner cannula contains a polymeric material.

[0185] Example 15

[0186] The device according to Example 14, wherein the inner cannula contains polyimide.

[0187] Example 16

[0188] The device according to any one of Examples 1 to 15, wherein at least one fluid includes a first and a second fluid, and the device further comprises first and second proximal fluid supply channels configured to be selectively fluidly coupled to the lumen of the inner cannula to supply the first and second fluids to the lumen, respectively.

[0189] Example 17

[0190] The apparatus according to Example 16, further comprising first and second valves configured to selectively fluidly couple first and second proximal fluid supply channels to the lumen of an inner cannula, respectively.

[0191] Example 18

[0192] The apparatus according to Example 17, wherein the first and second valves each include first and second disc valves, respectively.

[0193] Example 19

[0194] The apparatus according to Example 17 or 18, wherein in response to the fluid pressure in each of the first or second fluid channels being equal to or greater than a threshold fluid pressure, the first and second valves are each configured to fluidly couple the respective first or second proximal fluid supply channel to the lumen of the inner cannula.

[0195] Example 20

[0196] The apparatus according to Example 19, wherein in response to the fluid pressure in each of the first or second fluid channels being less than a threshold fluid pressure, the first and second valves are each configured to fluidly isolate the respective first or second proximal fluid supply channel from the lumen of the inner cannula.

[0197] Example 21

[0198] 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 and configured to dispense at least one fluid to a fluid injection device held by the operator.

[0199] Example 22

[0200] The apparatus according to Example 21, wherein the wearable component includes at least one of a wristband or a cuff configured to be fixed to the operator's wrist.

[0201] Example 23

[0202] The apparatus according to Example 21 or 22, wherein at least one syringe comprises a pair of syringes.

[0203] Example 24

[0204] The apparatus according to any one of Examples 21 to 23, further comprising a cradle configured to hold at least one syringe, the cradle being coupled to a wearable component.

[0205] Example 25

[0206] The apparatus according to Example 24, wherein the cradle is removably coupled to the wearable component.

[0207] Example 26

[0208] The apparatus according to Example 25, wherein the cradle is removably coupled to the wearable component via magnetic attraction.

[0209] Example 27

[0210] The apparatus according to any one of Examples 24 to 26, wherein the cradle includes a lighting chamber configured to receive a lighting portion of a chandelier for illuminating at least one syringe.

[0211] Example 28

[0212] The apparatus according to Example 27, further comprising a chandelier socket configured to selectively receive a chandelier.

[0213] Example 29

[0214] The apparatus according to Example 27 or 28, wherein the cradle includes a bore configured to receive at least one syringe, and the lighting chamber opens into the bore via an opening.

[0215] Example 30

[0216] The apparatus according to any one of Examples 27 to 29, further comprising a chandelier, the chandelier including an illumination portion, the illumination portion being disposed within an illumination chamber of the cradle.

[0217] Example 31

[0218] An apparatus comprising: (a) a first syringe including (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 including (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 pressurized fluid medium source; (d) an inlet port fluidly coupled to the pressurized fluid medium source; (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 movable between (i) a closed state in which the inlet port is fluidly isolated from each of the first and second outlet ports, (ii) a first open state in which the inlet port is fluidly isolated from the second outlet port and the inlet port is fluidly coupled to the first outlet port to direct pressurized fluid medium from the pressurized fluid medium source to the first proximal end of the first syringe to advance the first piston distally, thereby dispensing 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 the inlet port is fluidly coupled to the second outlet port to direct pressurized fluid medium from the pressurized fluid medium source to the second proximal end of the second syringe to advance the second piston distally, thereby dispensing the second fluid from the second distal end.

[0219] Example 32

[0220] The device according to Example 31, wherein the first fluid comprises a biologically inert BSS fluid and the second fluid comprises a biologically active therapeutic fluid.

[0221] Example 33

[0222] 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, the inner cannula having (i) an open proximal end, (ii) an open distal end configured to pierce a layer of a patient's eye to access the subretinal region of the eye, and (iii) a lumen extending between the open proximal end and the open distal end, the lumen configured to allow the first and second fluids to flow from the open proximal end to the open distal end to deliver the first and second fluids to the subretinal region of the eye; and (d) a fluid supply assembly comprising (i) first and second proximal fluid supply flow paths configured to selectively fluidly couple to the lumen of the inner cannula to supply the first and second fluids to the lumen, respectively, and (ii) first and second dish valves configured to selectively fluidly couple the first and second proximal fluid supply flow paths to the lumen of the inner cannula, respectively.

[0223] Example 34

[0224] The device according to Example 33, wherein in response to the fluid pressure in each of the first or second fluid flow paths being equal to or greater than a threshold fluid pressure, each of the first and second dish valves is configured to fluidly couple the respective first or second proximal fluid supply flow path to the lumen of the inner cannula.

[0225] Example 35

[0226] The device according to Example 33 or 34, wherein in response to the fluid pressure in each of the first or second fluid flow paths being less than a threshold fluid pressure, each of the first and second dish valves is configured to fluidly isolate the respective first or second proximal fluid supply flow path from the lumen of the inner cannula.

[0227] V. Others

[0228] It should be understood that any version of the apparatus described herein may include various other features in addition to, or instead of, those described above. By way of mere example, any of the devices herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0229] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the above-described teachings, expressions, embodiments, examples, etc. should not be viewed in isolation from one another. Various suitable ways of combining the teachings herein will be readily apparent to those skilled in the art considering the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0230] It should be understood that any patent, publication, or other disclosure material said to be incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with the existing definitions, descriptions, or other disclosure material described in this disclosure. Thus, to the extent necessary, the disclosure explicitly described herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof said to be incorporated herein by reference but conflicting with the existing definitions, descriptions, or other disclosure material described herein is incorporated only to the extent that no conflict arises between the incorporated material and the existing disclosure material.

[0231] The above versions may be designed to be discarded after a single use or may be designed for multiple uses. The versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of steps of disassembling the device, subsequently cleaning or replacing certain components, and then reassembling it. In particular, some versions of the device may be disassembled and any number of specific components or parts of the device may be selectively replaced or removed in any combination. When cleaning and / or replacing specific components, some versions of the device may be reassembled for subsequent use at a reconditioning facility or by an operator immediately prior to the procedure. One of ordinary skill in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly may be utilized for reconditioning the device. The use of such techniques and the resulting reconditioned devices are all within the scope of this application.

[0232] By way of mere example, the versions described herein may be sterilized before and / or after the procedure. In one sterilization technique, the device is placed within a closed, sealed container such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation can kill bacteria on the device and within the container. The sterilized device may then be stored in the sterilized container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma rays, ethylene oxide, or steam.

[0233] Although various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein can be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Some such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, embodiments, geometric shapes, materials, dimensions, ratios, steps, etc. described above are illustrative and not essential. Accordingly, the scope of the present invention should be considered with respect to the following claims and is understood not to be limited to the details of the structures and operations shown and described in this specification and the drawings.

[0234] 〔Embodiment〕 (1) An apparatus, (a) a main body, (b) an outer cannula extending distally from the main body along a longitudinal axis and fixedly secured to the main body, (i) a proximal portion having a first cross-sectional dimension, (ii) a distal portion having at least one second cross-sectional dimension smaller than the first cross-sectional dimension, the distal portion being configured to guide the cylindrical proximal portion into a trocar port for advancing the outer cannula into a patient's eye, including an outer cannula, (c) an inner cannula extending along the longitudinal axis and slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, (i) an open proximal end, (ii) an open distal end configured to puncture the retina of the eye, (iii) a lumen extending between the open proximal end and the open distal end, the lumen being configured to allow the at least one fluid to flow from the open proximal end to the open distal end for delivering at least one fluid to a subretinal region of the eye, including an inner cannula, including an apparatus. (2) The apparatus according to embodiment 1, wherein the distal portion tapers radially inwards in the distal direction. (3) The apparatus according to Embodiment 1, wherein the distal portion is curved radially inwardly in the distal direction. (4) The apparatus according to any one of Embodiments 1 to 3, wherein the proximal portion is substantially cylindrical. (5) The apparatus according to Embodiment 4, wherein the distal portion is substantially frustoconical.

[0235] (6) The apparatus according to any one of Embodiments 1 to 5, wherein the proximal portion defines a proximal opening, and the distal portion defines a distal opening that is smaller than the proximal opening. (7) The apparatus according to Embodiment 6, wherein the distal opening is configured to maintain centering of the inner cannula relative to the outer cannula during longitudinal translation of the inner cannula relative to the outer cannula. (8) The apparatus according to any one of Embodiments 1 to 7, wherein the open distal end is inclined. (9) The apparatus according to Embodiment 8, wherein the open distal end is oriented at an angle of about 45 degrees relative to the longitudinal axis. (10) The apparatus according to any one of Embodiments 1 to 9, wherein the outer cannula is rigid.

[0236] (11) The apparatus according to any one of Embodiments 1 to 10, wherein the outer cannula comprises a metallic material. (12) The apparatus according to Embodiment 11, wherein the outer cannula comprises surgical stainless steel. (13) The apparatus according to any one of Embodiments 1 to 12, wherein the inner cannula is flexible. (14) The apparatus according to any one of Embodiments 1 to 13, wherein the inner cannula comprises a polymeric material. (15) The apparatus according to Embodiment 14, wherein the inner cannula comprises polyimide.

[0237] (16) The at least one fluid includes a first and a second fluid, and the apparatus further comprises first and second proximal fluid supply flow paths configured to be selectively fluidly coupled to the lumen of the inner cannula to supply the first and second fluids to the lumen, respectively, of the apparatus according to any one of embodiments 1 to 15. (17) The apparatus according to embodiment 16 further comprises first and second valves configured to selectively fluidly couple the first and second proximal fluid supply flow paths to the lumen of the inner cannula, respectively. (18) The apparatus according to embodiment 17, wherein the first and second valves each include a first and a second disk valve, respectively. (19) In response to the fluid pressure in each of the respective first or second fluid flow paths being equal to or greater than a threshold fluid pressure, the first and second valves are each configured to fluidly couple the respective first or second proximal fluid supply flow path to the lumen of the inner cannula, of the apparatus according to embodiment 17 or 18. (20) In response to the fluid pressure in each of the respective first or second fluid flow paths being less than the threshold fluid pressure, the first and second valves are each configured to fluidly isolate the respective first or second proximal fluid supply flow path from the lumen of the inner cannula, of the apparatus according to embodiment 19.

[0238] (21) An apparatus, (a) a wearable component configured to be worn by an operator; (b) at least one syringe supported by the wearable component and configured to dispense at least one fluid to a fluid injection device held by the operator; comprising the apparatus. (22) The apparatus according to embodiment 21, wherein the wearable component includes at least one of a wristband or a cuff configured to be fixed to the operator's wrist. (23) The apparatus according to embodiment 21 or 22, wherein the at least one syringe includes a pair of syringes. (24) The apparatus according to any one of embodiments 21 to 23, further comprising a cradle configured to hold the at least one syringe, the cradle being coupled to the wearable component. (25) The apparatus according to embodiment 24, wherein the cradle is removably coupled to the wearable component.

[0239] (26) The apparatus according to embodiment 25, wherein the cradle is removably coupled to the wearable component via magnetic attraction. (27) The apparatus according to any one of embodiments 24 to 26, wherein the cradle includes an illumination chamber configured to receive an illumination portion of a chandelier for illuminating the at least one syringe. (28) The apparatus according to embodiment 27, further comprising a chandelier socket configured to selectively receive the chandelier. (29) The apparatus according to embodiment 27 or 28, wherein the cradle includes a bore configured to receive the at least one syringe, and the illumination chamber opens into the bore via an opening. (30) The apparatus according to any one of embodiments 27 to 29, further comprising the chandelier, the chandelier including the illumination portion, and the illumination portion being disposed within the illumination chamber of the cradle.

[0240] (31) An apparatus, (a) a first syringe, (i) a first proximal end, (ii) a first distal end configured to dispense a first fluid, (iii) a first piston disposed between the first proximal end and the first distal end, a first syringe including: (b) a second syringe, (i) a second proximal end, (ii) a second distal end configured to dispense a second fluid, (iii) a second piston disposed between the second proximal end and the second distal end, a second syringe, comprising (c) a pressurized fluid medium source, (d) an inlet port fluidly coupled to the pressurized fluid medium source, (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, (g) a fluid selector, (i) a closed state in which the inlet port is fluidly isolated from each of the first and second outlet ports, (ii) a first open state in which the inlet port is fluidly isolated from the second outlet port and the inlet port is fluidly coupled to the first outlet port to direct a pressurized fluid medium from the pressurized fluid medium source to the first proximal end of the first syringe to advance the first piston distally, thereby dispensing the first fluid from the first distal end, (iii) a second open state in which the inlet port is fluidly isolated from the first outlet port and the inlet port is fluidly coupled to the second outlet port to direct a pressurized fluid medium from the pressurized fluid medium source to the second proximal end of the second syringe to advance the second piston distally, thereby dispensing the second fluid from the second distal end, a movable fluid selector therebetween, and an apparatus comprising (32) The apparatus according to embodiment 31, wherein the first fluid comprises a biologically inert bulbar fluid and the second fluid comprises a biologically active therapeutic fluid. (33) An apparatus, (a) a body, (b) an outer cannula extending distally from the body, (c) an inner cannula slidably disposed within the outer cannula for translational movement longitudinally with respect to the outer cannula, (i) an open proximal end, (ii) an open distal end configured to pierce a layer of a patient's eye to access the subretinal region of the eye, (iii) A lumen extending between the open proximal end and the open distal end, configured to flow the first and second fluids from the open proximal end to the open distal end for delivering the first and second fluids to the subretinal region of the eye. An inner cannula, comprising (d) A fluid supply assembly, (i) First and second proximal fluid supply channels configured to be selectively fluidly coupled to the lumen of the inner cannula for supplying the first and second fluids to the lumen respectively. (ii) First and second disc valves configured to selectively fluidly couple the first and second proximal fluid supply channels to the lumen of the inner cannula respectively. A fluid supply assembly, comprising An apparatus, comprising (34) The apparatus according to embodiment 33, wherein in response to the fluid pressure in each of the respective first or second fluid channels being equal to or greater than a threshold fluid pressure, the first and second disc valves are each configured to fluidly couple the respective first or second proximal fluid supply channel to the lumen of the inner cannula. (35) The apparatus according to embodiment 33 or 34, wherein in response to the fluid pressure in each of the respective first or second fluid channels being less than the threshold fluid pressure, the first and second disc valves are each configured to fluidly isolate the respective first or second proximal fluid supply channel from the lumen of the inner cannula.

Claims

**Claim 1** An apparatus comprising: (a) a body; (b) an outer cannula extending distally from the body along a longitudinal axis and fixedly secured to the body, the outer cannula having: (i) a proximal portion having a first cross-sectional dimension; and (ii) a distal portion having at least one second cross-sectional dimension smaller than the first cross-sectional dimension, the distal portion configured to guide the cylindrical proximal portion into a trocar port for advancing the outer cannula into a patient's eye; wherein the outer cannula comprises the above; (c) an inner cannula extending along the longitudinal axis and slidably disposed within the outer cannula for longitudinal translation relative to the outer cannula, the inner cannula having: (i) an open proximal end; (ii) an open distal end configured to puncture the retina of the eye; and (iii) a lumen extending between the open proximal end and the open distal end and configured to allow at least one fluid to flow from the open proximal end to the open distal end for delivering the at least one fluid to a subretinal region of the eye; wherein the inner cannula comprises the above; An apparatus comprising the above. **Claim 2** The apparatus according to claim 1, wherein the distal portion tapers radially inwardly in the distal direction. **Claim 3** The apparatus according to claim 1, wherein the distal portion curves radially inwardly in the distal direction. **Claim 4** The apparatus according to any one of claims 1 to 3, wherein the proximal portion is substantially cylindrical. **Claim 5** The apparatus according to claim 4, wherein the distal portion is substantially frustoconical. **Claim 6** The apparatus according to claim 1, wherein the proximal portion defines a proximal opening and the distal portion defines a distal opening smaller than the proximal opening. **Claim 7** The apparatus according to claim 6, wherein the distal opening is configured to maintain centering of the inner cannula relative to the outer cannula during longitudinal translation of the inner cannula relative to the outer cannula. **Claim 8** The apparatus according to claim 1, wherein the open distal end is inclined. **Claim 9** The apparatus according to claim 8, wherein the open distal end is oriented at an angle of approximately 45 degrees relative to the longitudinal axis. **Claim 10** The apparatus according to claim 1, wherein the outer cannula is rigid. **Claim 11** The apparatus according to claim 1, wherein the outer cannula comprises a metallic material. **Claim 12** The apparatus according to claim 11, wherein the outer cannula comprises surgical stainless steel.

13. The apparatus according to claim 1, wherein the inner cannula is flexible.

14. The apparatus according to claim 1, wherein the inner cannula comprises a polymeric material.

15. The apparatus according to claim 14, wherein the inner cannula comprises polyimide.

16. The at least one fluid comprises first and second fluids, and the apparatus further comprises first and second proximal fluid supply flow paths configured to be selectively fluidly coupled to the lumen of the inner cannula to supply the first and second fluids to the lumen, respectively. The apparatus according to claim 1.

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

18. The apparatus according to claim 17, wherein the first and second valves each comprise first and second disc valves, respectively.

19. In response to the fluid pressure in each of the respective first or second fluid flow paths being equal to or greater than a threshold fluid pressure, each of the first and second valves is configured to fluidly couple the respective first or second proximal fluid supply flow path to the lumen of the inner cannula. The apparatus according to claim 17 or 18.

20. In response to the fluid pressure in each of the respective first or second fluid flow paths being less than the threshold fluid pressure, each of the first and second valves is configured to fluidly isolate the respective first or second proximal fluid supply flow path from the lumen of the inner cannula. The apparatus according to claim 19.

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

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

23. The apparatus according to claim 21 or 22, wherein the at least one syringe comprises a pair of syringes.

24. The apparatus according to claim 21, further comprising a cradle configured to hold the at least one syringe, the cradle being coupled to the wearable component.

25. The apparatus according to claim 24, wherein the cradle is removably coupled to the wearable component.

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

27. The apparatus according to any one of claims 24 to 26, wherein the cradle includes an illumination chamber configured to receive an illumination portion of a chandelier for illuminating the at least one syringe.

28. The apparatus according to claim 27, further comprising a chandelier socket configured to selectively receive the chandelier.

29. The apparatus according to claim 27, wherein the cradle includes a bore configured to receive the at least one syringe, and the illumination chamber opens into the bore via an opening.

30. The apparatus according to claim 27, further comprising the chandelier, the chandelier including the illumination portion, and the illumination portion being disposed within the illumination chamber of the cradle.

31. An apparatus comprising: (a)A first syringe, comprising: (i)A first proximal end; (ii)A first distal end configured to dispense a first fluid; (iii)A first piston disposed between the first proximal end and the first distal end; A first syringe; (b)A second syringe, comprising: (i)A second proximal end; (ii)A second distal end configured to dispense a second fluid; (iii)A second piston disposed between the second proximal end and the second distal end; A second syringe; (c)A pressurized fluid medium source; (d)An inlet port fluidly coupled to the pressurized fluid medium source; (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; (g)A fluid selector, comprising: (i)A closed state in which the inlet port is fluidly isolated from each of the first and second outlet ports; (ii) the inlet port is fluidically isolated from the second outlet port, the inlet port is fluidically coupled to the first outlet port, and a pressurized fluid medium is conducted from the pressurized fluid medium source to the first proximal end of the first syringe to advance the first piston distally, thereby dispensing the first fluid from the first distal end; a first open state; (iii) the inlet port is fluidically isolated from the first outlet port, the inlet port is fluidically coupled to the second outlet port, and a pressurized fluid medium is conducted from the pressurized fluid medium source to the second proximal end of the second syringe to advance the second piston distally, thereby dispensing the second fluid from the second distal end; a second open state; a movable fluid selector therebetween; An apparatus comprising. The apparatus of claim 31, wherein the first fluid comprises a biologically inert bulbar fluid and the second fluid comprises a biologically active therapeutic fluid. An apparatus, (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, the inner cannula having: (i) an open proximal end, (ii) an open distal end configured to puncture a layer of a patient's eye to access the subretinal region of the eye, (iii) a lumen extending between the open proximal end and the open distal end and configured to flow the first and second fluids from the open proximal end to the open distal end for delivering the first and second fluids to the subretinal region of the eye; An inner cannula comprising; (d) a fluid supply assembly, (i) first and second proximal fluid supply flow paths configured to selectively fluidically couple to the lumen of the inner cannula for supplying the first and second fluids to the lumen, respectively, (ii) first and second disc valves configured to selectively fluidically couple the first and second proximal fluid supply flow paths to the lumen of the inner cannula, respectively; A fluid supply assembly comprising; An apparatus comprising. ​ In response to the fluid pressure in each of the first or second fluid flow paths being equal to or greater than a threshold fluid pressure, each of the first and second disc valves is configured to fluidly couple each of the first or second proximal fluid supply flow paths to the lumen of the inner cannula, the apparatus of claim 33.

35. In response to the fluid pressure in each of the first or second fluid flow paths being less than the threshold fluid pressure, each of the first and second disc valves is configured to fluidly isolate each of the first or second proximal fluid supply flow paths from the lumen of the inner cannula, the apparatus of claim 33 or 34.

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