Torque ring for subretinal injection device

Abstract

An apparatus includes an instrument body and a flexible cannula extending distally from the instrument body, the flexible cannula sized and configured to be advanced between a sclera and choroid of an eye of a patient. The apparatus also includes a needle configured to translate relative to the cannula between a proximal position and a distal position. The apparatus further includes a rotational knob (422) configured to rotate relative to the instrument body about a rotational axis and thereby drive the needle to translate between the proximal position and the distal position. The apparatus also includes a deflectable member (460) fixed to resist rotation relative to one of the instrument body or the rotational knob. The deflectable member is configured to frictionally engage the other of the instrument body or the rotational knob to prevent rotation of the rotational knob about the rotational axis without a predetermined threshold rotational force being applied to the rotational knob.

Description

[0001] priority

[0002] This application claims the benefit of U.S. Patent Application No. 63 / 570,372, filed March 27, 2024, entitled “Torque Ring for Subretinal Injection Device,” the disclosure of which is incorporated herein by reference. Background Technology

[0003] The human eye consists of several layers. The white outer layer is the sclera, which surrounds the choroid. The retina lies inside the choroid. The sclera contains collagen and elastic fibers, providing protection for the choroid and retina. The choroid contains the vascular system, which supplies oxygen and nutrients to the retina. The retina contains light-sensitive tissues, including rods and cones. The macula is located at the center of the retina at the back of the eye, usually centered on the optical axis (the axis that runs through the center of the lens and cornea). The macula provides central vision, especially through the cone cells.

[0004] Macular degeneration (AMD) is a medical condition affecting the macula, causing people with AMD to experience loss or deterioration of central vision while retaining some degree of peripheral vision. Macular degeneration can be caused by a variety of factors, such as age (also known as age-related macular degeneration or "AMD") and genetics. AMD can occur in a "dry" (non-exudative) form, where cellular debris called drusen accumulates between the retina and choroid, resulting in map-like areas of atrophy. AMD can also occur in a "wet" (exudative) form, where blood vessels grow from the choroid behind the retina. Although people with AMD may retain some degree of peripheral vision, the loss of central vision can have a significant negative impact on their quality of life. Furthermore, the quality of the remaining peripheral vision may decline, and in some cases, it may even disappear. Therefore, treatment for AMD may be desired to prevent or reverse the vision loss caused by it. In some cases, it may be desirable to provide such treatment near the macula in a highly localized manner, such as by delivering therapeutic material directly adjacent to the subretinal layer (below the neurosensory layer of the retina and above the retinal pigment epithelium) of the map-like atrophy area. However, because the macula is located at the back of the eye and below the fragile layer of the retina, it may be difficult to access it in a practical way.

[0005] Although various surgical methods and instruments have been manufactured and used to treat the eyes, it is believed that no one had manufactured or used the invention described in the appended claims before the inventors. Attached Figure Description

[0006] Although this specification concludes with the claims that specifically point out and clearly claim protection for the present technology, it is believed that the present technology will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which the same reference numerals denote the same elements and wherein:

[0007] Figure 1 is a perspective view depicting an example of a device for subretinal administration of therapeutic agents via the suprachoroidal route.

[0008] Figure 2 is a perspective view of the distal portion of the cannula of the instrument in Figure 1.

[0009] Figure 3 depicts a frontal view of the distal portion of the cannula in Figure 2;

[0010] Figure 4 depicts a top plan view of the distal portion of the cannula in Figure 2;

[0011] Figure 5 depicts a perspective view of the distal end of the cannula in Figure 2, with the needle extending from the cannula;

[0012] Figure 6 depicts an exploded perspective view of a portion of the instrument of Figure 1, showing the needle actuation assembly of the instrument;

[0013] Figure 7 depicts a perspective view of the rotating cam of the needle actuation assembly in Figure 6;

[0014] Figure 8 depicts a perspective view of the frame components of the needle actuator assembly of Figure 6;

[0015] Figure 9 depicts a perspective view of the needle driver of the needle actuator assembly of Figure 6;

[0016] Figure 10A depicts a cross-sectional view of the needle actuator assembly of Figure 6, wherein the rotary cam of Figure 7 is in the first angular position and the needle driver of Figure 9 is in the proximal position.

[0017] Figure 10B depicts a cross-sectional view of the needle actuator assembly of Figure 6, wherein the rotary cam of Figure 7 is in the second angular position and the needle driver of Figure 9 is in the distal position.

[0018] Figure 11 depicts a perspective view of the circuit board assembly of the device in Figure 1;

[0019] Figure 12 depicts a perspective view of the device in Figure 1, which is installed near the patient and has a combination of medical facilities.

[0020] Figure 13A depicts a cross-sectional side view of the patient's eye;

[0021] Figure 13B depicts a cross-sectional side view of the eye of Figure 13A, with a suture loop attached to the eye and a sclerotomy performed therein;

[0022] Figure 13C depicts a cross-sectional side view of the eye of Figure 13A, wherein the cannula of Figure 2 is inserted through a scleral incision and between the sclera and choroid of the eye.

[0023] Figure 13D depicts a cross-sectional side view of the eye in Figure 13A, with the distal end of the cannula positioned adjacent to the target location.

[0024] Figure 13E depicts a cross-sectional side view of the eye of Figure 13A, in which the needle of Figure 5 travels through the choroid to enter the subretinal space at the target location;

[0025] Figure 13F depicts a cross-sectional side view of the eye of Figure 13A, in which the needle of Figure 5 dispenses a first volume of guide bubble fluid to provide separation between the retinal area and the choroid at the target location.

[0026] Figure 13G depicts a cross-sectional side view of the eye of Figure 13A, in which the needle of Figure 5 dispenses the therapeutic agent between the retinal area and the choroid at the target location.

[0027] Figure 14 depicts a perspective view of another example of a device for administering a therapeutic agent via a suprachoroidal route under the retina, operatively coupled to an example of a fluid control unit.

[0028] Figure 15 depicts a perspective view of the rotary knob assembly of the instrument in Figure 14;

[0029] Figure 16 depicts an exploded perspective view of the rotary knob assembly of Figure 15;

[0030] Figure 17 depicts a perspective view of the knob body of the rotary knob assembly of Figure 15;

[0031] Figure 18 depicts a perspective view of the torque ring of the rotary knob assembly of Figure 15;

[0032] Figure 19 depicts a perspective view of the slip clutch of the rotary knob assembly of Figure 15;

[0033] Figure 20 depicts a perspective view of the knob base of the rotary knob assembly of Figure 15;

[0034] Figure 21A depicts a partial side cross-sectional view of the instrument of Figure 14 taken along line 21-21 in Figure 14, wherein the rotary knob assembly of Figure 15 is in the first angular position and the needle driver of Figure 9 is in the proximal position.

[0035] Figure 21B depicts a partial side cross-sectional view of the instrument of Figure 14 taken along line 21-21 in Figure 14, wherein the rotary knob assembly of Figure 15 is in the second angle position and the needle driver of Figure 9 is in the distal position.

[0036] Figure 22A depicts a partial top cross-sectional view of the device of Figure 14 taken along line 22-22 in Figure 14, wherein the first and second valves of the fluid supply assembly of the device are in the corresponding closed state.

[0037] Figure 22B depicts a partial top cross-sectional view of the instrument of Figure 14 taken along line 22-22 in Figure 14, wherein the first valve of the fluid supply assembly is in an open state for supplying first fluid to the needle of the instrument, and wherein the second valve of the fluid supply assembly is in a closed state.

[0038] Figure 22C depicts a partial top cross-sectional view of the instrument of Figure 14 taken along line 22-22 in Figure 14, wherein the first valve of the fluid supply assembly is in a closed state, and wherein the second valve of the fluid supply assembly is in an open state for supplying a second fluid to the needle of the instrument.

[0039] Figure 23 is a schematic diagram of the circuit board assembly of the device in Figure 14;

[0040] Figure 24 depicts a perspective view of another example of a fluid control unit for use with either of the instruments of Figures 1 and 14, showing the fluid control unit operatively coupled to the instrument and to the off-board processor, and further showing the fluid control unit mounted to the wrist rest of Figure 12.

[0041] Figure 24A depicts a side view of the fluid control unit of Figure 24, showing its installation via the mounting assembly. Figure 12 The wrist-mounted fluid control unit;

[0042] Figure 25 depicts an exploded perspective view of the fluid control unit of Figure 24, showing the control module and housing of the fluid control unit;

[0043] Figure 26 depicts a top plan view of the control module of Figure 25;

[0044] Figure 27 depicts a front view of the distal end of the control module of Figure 25;

[0045] Figure 28 depicts an exploded perspective view of the control module of Figure 25, showing the upper and lower housings of the control module, the first and second drive components, and the circuit board assembly.

[0046] Figure 29 depicts a perspective view of the first and second drive components of Figure 28;

[0047] Figure 30 depicts a side view of the first drive assembly and the second drive assembly of Figure 28;

[0048] Figure 31 depicts a perspective view of the circuit board assembly and lower housing of Figure 28;

[0049] Figure 32 depicts a top plan view of the box in Figure 25;

[0050] Figure 33 depicts a bottom plan view of the box in Figure 25;

[0051] Figure 34 depicts a rear view of the proximal end of the box of Figure 25; and

[0052] Figure 35 depicts an exploded perspective view of the box in Figure 25.

[0053] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the present technology are contemplated that they may be implemented in a variety of other ways, including those not necessarily depicted in the drawings. The drawings, which are incorporated in and form part of this specification, depict several aspects of the present technology and, together with the description, serve to explain the principles of the present technology; however, it should be understood that the present technology is not limited to the exact arrangement shown. Detailed Implementation

[0054] The following description of specific examples of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for implementing the present technology for illustrative purposes. As will be appreciated, the technology described herein can have other different and apparent aspects, all of which do not depart from the present technology. Therefore, the drawings and descriptions should be considered illustrative in nature rather than limiting.

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

[0056] For clarity, the terms “proximal” and “distal” are defined herein as relative to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term “proximal” refers to the position where the element is closer to the surgeon or other operator, and the term “distal” refers to the position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon or other operator.

[0057] Furthermore, the terms “about,” “approximately,” etc., used in conjunction with any numerical value or range of values ​​herein are intended to encompass one or more precise values ​​referenced, as well as appropriate tolerances that enable the referenced feature or combination of features to be used for the intended purpose described herein.

[0058] I. Devices for administering therapeutic agents subretinal.

[0059] Figure 1 illustrates an example of an instrument (100) configured for use in a surgical procedure for subretinal administration of a therapeutic agent to a patient's eye via a suprachoroidal route. The instrument (100) comprises a pair of housing halves (110, 111), a pair of rockers (112, 114), a rotary knob (120), and a flexible cannula (130) extending distally from the housing halves (110, 111). Also as shown in Figure 1, a cannula assembly (140) extends proximally from the instrument (100). The cannula (130) in this example has a generally rectangular cross-section, but any other suitable cross-sectional profile (e.g., elliptical, etc.) may be used. The generally rectangular cross-sectional profile of the cannula (130) is configured such that the cannula (130) can pass through the suprachoroidal space without damage, as will be described in more detail below. The cannula (130) is typically configured to support a needle (150) that can slide within the cannula (130), as will be described in more detail below.

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

[0061] By way of example only, the cannula (130) may be constructed and operated in accordance with at least some of the teachings of the following and / or in any other suitable manner: U.S. Patent No. 10,226,379, entitled “Method and Apparatus for Subretinal Administration of Therapeutic Agent”, issued March 12, 2019, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 10,646,374, entitled “Apparatus and Method to From Entry Bleb for Subretinal Delivery of Therapeutic Agent”, issued May 12, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0062] As shown in Figure 5, the needle (150) can travel distally to protrude from the opening (134). The needle (150) of this example has a sharp distal tip (152) and defines a lumen (not shown). The distal tip (152) of this example has a lancet construction. In some other versions, the distal tip (152) has a tri-bevel construction or any other construction as described in U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Other suitable forms that the distal tip (152) may take will be apparent to those skilled in the art in light of the teachings herein. In this example, when the cannula (130) is positioned in the suprachoroidal space, the generally rectangular, generally elliptical, or other generally flat cross-sectional profile of the cannula (130) prevents the cannula (130) from rotating about its longitudinal axis, as will be described in more detail below. This provides a consistent and predictable orientation of the opening (134), thereby providing a consistent and predictable exit path for the needle (150) as it travels distally relative to the cannula (130), as will be described in more detail below.

[0063] By way of example only, after the needle (150) has traveled distally relative to the cannula (130), the angle defined between the exposed portion of the needle (150) and the cannula (130) can be in the range of approximately 5° to approximately 30° relative to the longitudinal axis of the cannula (130); or more specifically, in the range of approximately 5° to approximately 20° relative to the longitudinal axis of the cannula (130); or more specifically, in the range of approximately 5° to approximately 10° relative to the longitudinal axis of the cannula (130); or more specifically, in the range of approximately 7° and approximately 9° relative to the longitudinal axis of the cannula (130). In this example, the needle (150) is elastically biased to present a curved configuration, thereby providing an exit angle that varies based on the degree of distal travel of the needle (150) relative to the cannula (130). As another example only, the needle (150) may include at least some of the teachings of U.S. Patent No. 10,478,553, entitled “Apparatus for Subretinal Administration of Therapeutic Agent via a Curved Needle,” published November 19, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0064] A rotary knob (120) is rotatable relative to the housing halves (110, 111) to selectively translate the needle (150) longitudinally relative to the cannula (130). Specifically, the rotary knob (120) is rotatable in a first angular direction to drive the needle (150) distally relative to the cannula (130) and in a second angular direction to drive the needle (150) proximally relative to the cannula (130). In this respect, and as shown in FIG. 6, the instrument (100) further includes a frame member (160), a circuit board assembly (170), and a needle driver / needle actuator (180). As shown in FIG. 6, the rotary knob (120), the frame member (160), and the needle actuator (180) are coupled together to form an assembly. The rotary knob (120) is operable to rotate relative to the housing halves (110, 111). The frame member (160) is configured to be monolithically fastened to the housing halves (110, 111) such that the frame member (160) remains stationary relative to the housing halves (110, 111). The needle actuator (180) is operable to translate relative to the housing halves (110, 111) in response to rotation of the rotary knob (120) relative to the housing halves (110, 111). As shown in FIG. 7, the underside of the rotary knob (120) includes a helical cam recess (124). As shown in FIG. 8, the frame member (160) includes a pair of support rails (162) and a guide slot (164). As shown in FIG. 9, the needle actuator (180) includes a pair of guide wings (182) and a cam follower post (184). The guide wings (182) are sized and configured to engage the support rails (162). This engagement provides vertical and lateral support to the needle actuator (180) while allowing the needle actuator (180) to slide longitudinally relative to the frame member (160). The guide slot (164) is configured to receive the cam follower (184) and accommodate the sliding movement of the cam follower as the needle actuator (180) slides longitudinally relative to the frame member (160).

[0065] As shown in Figures 10A and 10B, the cam follower (184) of the needle actuator (180) is configured to fit precisely into the helical cam recess (124) of the rotary knob (120). Due to this engagement, and due to the guidance provided to the cam follower (184) by the guide slot (164), the needle actuator (180) will translate from a proximal position (Figure 10A) to a distal position (Figure 10B) in response to rotation of the rotary knob (120). The needle (150) is fixedly fastened to the needle actuator (180) such that the needle (150) will translate longitudinally relative to the cannula (130) in response to rotation of the rotary knob (120). By way of example only, the device (100) may provide such functionality via a knob (120) in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, the disclosure of which is incorporated herein by reference in its entirety. Other suitable ways in which rotational movement of the knob (120) can be converted into linear translation of the needle (150) will be apparent to those skilled in the art in light of the teachings herein. Similarly, other suitable ways in which the needle (150) can be actuated longitudinally relative to the cannula (130) in light of the teachings herein will be apparent to those skilled in the art.

[0066] As shown in Figure 11, the upper side of the circuit board assembly (170) includes a first tactile switch (172) and a linear sensor (176). The first tactile switch (172) can be positioned to be actuated by a pin (173) positioned between the first tactile switch (172) and a pin seat (not shown) on the lower side of an upper rocker plate (114). Such actuation of the tactile switch (172) can be provided by pressing the upper rocker plate (114) to pivot the upper rocker plate (114) about a pivot post (not shown), which will drive the pin downward toward the first tactile switch (172). The first tactile switch (172) can communicate with a control module (not shown) via one or more wires of wires (175) contained in the tube assembly (140). By way of example only, the control module may provide delivery of a therapeutic agent (341) via a needle (150) in response to actuation of the first tactile switch (172).

[0067] Although not shown, the underside of the circuit board assembly (170) may include a second tactile switch positioned to be actuated by an integral post of the lower rocker plate (112). Such actuation of the second tactile switch can be provided by a downwardly pivotally pushing the housing halves (110, 111) to pivot the housing halves (110, 111) about a pivot post (not shown), which will drive the second tactile switch downward toward the integral post. The second tactile switch may communicate with the control module via one or more wires of the wires (175) contained in the tube assembly (140). By way of example only, the control module may provide delivery of bubble fluid (340) via a needle (150) in response to actuation of the second tactile switch.

[0068] The linear sensor (176) includes a slider (178) configured to slide integrally with the needle actuator (180) and thereby translate longitudinally relative to the body of the linear sensor (176). The linear sensor (176) is configured to generate varying data values ​​based on the longitudinal position of the slider (178) along the body of the linear sensor (176). By way of example only, the linear sensor (176) may include a linear potentiometer that generates varying resistance values ​​based on the longitudinal position of the slider (178) along the body. Thus, the resistance value generated by the linear sensor (176) will indicate the longitudinal position of the needle (150) relative to the cannula (130). By way of another example only, the linear sensor (176) may include a sensor that senses the rotation of a knob (120), an optical sensor, or a sensor located in the instrument (100) to directly monitor the movement of the needle actuator (180). Given the teachings herein, various other suitable methods for sensing the movement of the needle (150) will be apparent to those skilled in the art. A linear sensor (176) communicates with a control module via one or more wires of wires (175) contained in the tube assembly (140). The control module can be configured to provide automated delivery of bubble fluid (340) via the needle (150) in response to distal movement of the needle (150) sensed by the linear sensor (176). By way of example only, the device (100) may provide these functionalities via a circuit board assembly (170) in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, the disclosure of which is incorporated herein by reference in its entirety.

[0069] II. Surgical procedures for delivering therapeutic agents to the subretinal space via the suprachoroidal route.

[0070] Figure 12 illustrates the positioning of the instrument (100) relative to the patient. In this example, a conventional ophthalmic surgical wrist rest (also known as a wrist rail) (10) is positioned adjacent to and / or partially around the patient's head to provide one or more points of support for the operator's wrist during operation of the instrument (100). A surgical drape (12) is positioned above the patient, with an opening (18) formed in the drape near the patient's eye (301). A speculum (16) is used to keep the eye (301) open. A fixation device (14) is positioned adjacent to the eye (301). The fixation device (14) can be used to fix an instrument, such as a viewing mirror, relative to the patient. A magnetic pad (30) is adhered to the surgical drape (12) near the opening (18) adjacent to the eye (301). The instrument (100) is placed on the magnetic pad (30) and removably secured to the magnetic pad via magnetic attraction. In this example, one or more permanent magnets (148) are positioned within the housing halves (110, 111); and these magnets are magnetically attracted to one or more ferro-containing elements (not shown) contained within the magnetic pad (30). By way of example only, these magnets and the magnetic pad (30) may be constructed according to at least some of the teachings of U.S. Patent No. 10,806,629, entitled “Injection Device for Subretinal Delivery of Therapeutic Agent,” published October 20, 2020, the disclosure of which is incorporated herein by reference in its entirety. The device (100) is oriented such that a flexible cannula (130) of the device (100) can be inserted into the eye (301). An example of the process of inserting and positioning the cannula (130) into the eye (301) is described in more detail below with reference to Figures 13A through 13F.

[0071] In this example, the instrument (100) is connected to a fluid delivery system (80) via a tubing assembly (140). In this example, the fluid delivery system (80) includes a bubble fluid source (82) and a therapeutic fluid source (84). The bubble fluid source (82) is connected to the bubble fluid conduit (142) of the tubing assembly (140); and the therapeutic fluid source (84) is connected to the therapeutic conduit (144) of the tubing assembly (140). The conduits (142, 144) are in fluid communication with a needle (150). In some versions, the fluid sources (82, 84) include syringes. In some other versions, the fluid sources (82, 84) include separate reservoirs and one or more associated pumps and / or valves, etc.

[0072] Figures 13A through 13G illustrate examples of procedures performed using the aforementioned facilities to deliver therapeutic agents from the suprachoroidal route to the subretinal space of the eye (301). These methods described herein are for illustrative purposes only and can be used to treat macular degeneration and / or other ocular conditions. Although the procedures described herein are discussed in the context of treating age-related macular degeneration, they are not intended to be or imply such limitations. For example, the same techniques described herein can be used in some alternative procedures to treat retinitis pigmentosa, diabetic retinopathy, and / or other ocular conditions. Furthermore, the procedures described herein can be used to treat other conditions such as dry or wet age-related macular degeneration.

[0073] In this example, the procedure begins with the operator stabilizing the tissues (e.g., eyelids) surrounding the patient's eye (301) using instruments such as a speculum (16) and / or any other suitable for stabilization. While this description of stabilization refers to the tissues surrounding the eye (301), the eye (301) itself remains free to move. As shown in Figure 13A, once the tissues surrounding the eye (301) have been stabilized, an eye chandelier port (314) is inserted into the eye (301) to provide intraocular illumination when viewing the interior of the eye (301) through the pupil. In this example, the eye chandelier port (314) is positioned in the inferior medial quadrant to allow for superior temporal quadrant sclerotomy. The eye chandelier port (314) is positioned to direct light into the interior of the eye (301) to illuminate at least a portion of the retina (308) (e.g., including at least a portion of the macula). As will be understood, such illumination corresponds to the area of ​​the eye (301) that is targeted for delivery of therapeutic agents.

[0074] In this example, at the stage shown in Figure 13A, only the chandelier port (314) is inserted; the optical fiber (315) has not yet been inserted into the port (314). In some other versions, the optical fiber (315) may be inserted into the chandelier port (314) at this stage. In either case, the eye may optionally be visually examined using a microscope to confirm the proper positioning of the eye chandelier port (314) relative to the target area. Although Figure 13A shows a specific positioning of the eye chandelier port (314), the eye chandelier port (314) may have any other suitable positioning as will be apparent to those skilled in the art in light of the teachings herein.

[0075] Once the eye chandelier port (314) is positioned, the conjunctiva can be separated by making a flap in the conjunctiva and pulling the flap back to access the sclera (304). After such separation, the exposed surface of the sclera (304) can optionally be cauterized with a cauterizing tool to whiten it and minimize bleeding. Once the conjunctival separation is complete, the exposed surface of the sclera (304) can optionally be dried using a WECK-CEL or other suitable absorption device.

[0076] The eye (301) can then be marked using a template, as described in: U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,000,410, published May 11, 2021, entitled “Guide Apparatus for Tangential Entry into Suprachoroidal Space,” the disclosure of which is incorporated herein by reference in its entirety. The operator can then use the visual guide created using the template to attach the suture loop assembly (332) and perform a sclerotomy using a conventional scalpel (313) or other suitable cutting instrument, as shown in Figure 13B. By way of example only, the suture loop assembly (332) can be formed according to at least some of the teachings of U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety. Alternatively, instead of the suture loop assembly (332), the operator may install the guide tack in accordance with at least some of the teachings of U.S. Patent No. 11,000,410, the disclosure of which is incorporated herein by reference in its entirety.

[0077] A sclerotomy creates a small incision in the sclera (304) through the eye (301). Care must be taken during a sclerotomy to avoid penetrating the choroid (306). Thus, the sclerotomy provides access to the space between the sclera (304) and the choroid (306). Once the incision is made in the eye (301), blunt dissection can optionally be performed to locally separate the sclera (304) from the choroid (306). Such separation can be performed using small, blunt, slender instruments, as will be apparent to those skilled in the art given the teachings herein.

[0078] As the sclerotomy proceeds, the operator can insert the cannula (130) of the instrument (100) through the incision and into the space between the sclera (304) and the choroid (306). As can be seen in Figure 13C, the cannula (130) is guided through the suture loop assembly (332) and into the incision. The suture loop assembly (332) can stabilize the cannula (130) during insertion. In addition, the suture loop assembly (332) maintains the cannula (130) in a generally tangential orientation relative to the incision. Such tangential orientation can reduce trauma as the cannula (130) is guided through the incision. As the cannula (130) is inserted into the incision through the suture loop assembly (332), the operator can use forceps or other instruments to further guide the cannula (130) along an atraumatic path. Of course, the use of forceps or other instruments is optional and may be omitted in some instances. As described above, a guide pin (or other device) may be used instead of the suture loop assembly (332). The cannula (130) is advanced until the distal end (132) is positioned near the target area in the subretinal space on the opposite side of the choroid (306). Given the teachings herein, various suitable methods for visualizing the distal end (132) to observe its proper positioning will be apparent to those skilled in the art.

[0079] Although not shown, in some instances, the cannula (130) may include one or more markings on its surface to indicate various insertion depths. While optional, such markings may be expected to assist the operator in identifying the appropriate insertion depth as the cannula (130) is guided along an atraumatic path. For example, the operator may visually observe the position of such markings relative to the suture loop assembly (332) and / or relative to an incision in the sclera (304) as an indicator of the depth at which the cannula (130) is inserted into the eye (301). By way of example only, one such marking may correspond to an insertion depth of approximately 6 mm for the cannula (130).

[0080] As shown in Figure 13D, once the cannula (130) is at least partially inserted into the eye (301), if the fiber (315) has not yet been inserted at this stage, the operator can insert the optical fiber (315) into the eye lamp port (314). With the eye lamp port (314) in place and assembled with the optical fiber (315), the operator can activate the eye lamp port (314) by guiding light through the optical fiber (315) to provide illumination to the eye (301) and thereby visualize the interior of the eye (301). At this point, the positioning of the cannula (130) can optionally be further adjusted to ensure proper positioning relative to the map-like atrophic area of ​​the retina (308). In some cases, the operator may wish to rotate the eye (301), such as by pulling the suture loop assembly (332), to guide the pupil of the eye (301) toward the operator in order to optimize visualization of the interior of the eye (301) via the pupil.

[0081] Figures 13C to 13D illustrate the following configuration of the cannula (130): guided between the sclera (304) and choroid (306) to position the distal end (132) of the cannula (130) at the delivery site for the therapeutic agent. In this example, the delivery site corresponds to the approximate posterior region of a map-like atrophic area in the eye (301) adjacent to the retina (308). Specifically, in this example, the delivery site is above the macula, in the potential space between the neurosensory retina and the retinal pigment epithelium. By way of example only, as the cannula (130) is advancing through the range of motion shown in Figures 13C to 13D, the operator can rely on direct visualization through a microscope guided through the pupil of the eye (301) using illumination provided via fiber optic (315) and port (314). The cannula (130) is at least partially visible through the retina (308) and choroid (306) of the eye (301). Visual tracking can be enhanced in a version that uses optical fibers to emit visible light through the distal end of the cannula (130).

[0082] Once the cannula (130) has traveled to the delivery site as shown in Figure 13D, the operator can advance the needle (150) of the instrument (100) via the actuation knob (120) as described above. As can be seen in Figure 13E, the needle (150) travels relative to the cannula (130) such that the needle (150) pierces the choroid (306) without penetrating the retina (308). Just before penetrating the choroid (306), the needle (150) can be directly visualized as “bulging” the surface of the choroid (306). In other words, the needle (150) can deform the choroid (306) by pushing it upwards, thus providing an appearance similar to the deformation of a tent pole at the top of a tent. The operator can use this visual phenomenon to identify whether the choroid (306) is about to be pierced and the location of any eventual piercing. The specific amount of travel of the needle (150) sufficient to initiate the “bulge” of the choroid (306) and subsequent puncture can be any suitable amount, as can be determined by a variety of factors, such as, but not limited to, general patient anatomy, local patient anatomy, operator preference, and / or other factors. Examples of the range of needle (150) travel, as described above, can be between approximately 0.25 mm and approximately 10 mm; or more specifically, between approximately 2 mm and approximately 6 mm.

[0083] In this example, after the operator has confirmed that the needle (150) has traveled properly by visualizing the bulge effect described above, the operator infuses a balanced salt solution (BSS) or other similar solution as the needle (150) travels relative to the cannula (130). Such a BSS can form a guide bubble (340) in front of the needle (150) as the needle (150) travels through the choroid (306). The guide bubble (340) may be desired for two reasons. First, as shown in Figure 13F, the guide bubble (340) can provide the operator with further visual indication of when the needle (150) is properly positioned at the delivery site. Second, once the needle (150) has penetrated the choroid (306), the guide bubble (340) can provide a barrier between the needle (150) and the retina (308). Such a barrier can push the retinal wall outward, thereby minimizing the risk of retinal perforation when the needle (150) travels to the delivery site. In some versions, a foot pedal is actuated to drive the guide bubble (340) out of the needle (150). Alternatively, other suitable features that can be used to drive the guide bubble (340) out of the needle (150) will be apparent to those skilled in the art, given the teachings herein.

[0084] Once the operator visualizes the guide bubble (340), the operator can terminate the BSS infusion, leaving a bag of fluid as can be seen in Figure 13F. The therapeutic agent (341) can then be infused via an actuated fluid delivery system (80) or some other fluid delivery device as described in the various references cited herein. The delivered therapeutic agent (341) can be any suitable therapeutic agent configured to treat an ocular condition. Some illustrative examples of suitable therapeutic agents may include, but are not limited to, drugs having small or large molecules, therapeutic cell solutions, specific gene therapy solutions, tissue plasminogen activators, and / or any other suitable therapeutic agent that will be apparent to those skilled in the art in light of the teachings herein. By way of example only, the therapeutic agent (341) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, entitled “Treatment of Retinitis Pigmentosa with Human Umbilical Cord Cells,” published August 19, 2008, the disclosure of which is incorporated herein by reference in its entirety. In addition to being used for the delivery of the therapeutic agent (341) or as an alternative thereto, the device (100) and variations thereof may be used to provide drainage and / or perform other procedures.

[0085] In this example, the final amount of therapeutic agent (341) delivered to the delivery site is approximately 50 μL, but any other suitable amount may be delivered. In some versions, a foot pedal is actuated to drive the agent (341) out of the needle (150). Alternatively, other suitable features that may be used to drive the agent (341) out of the needle (150) will be apparent to those skilled in the art, given the teachings herein. The delivery of the therapeutic agent (341) can be visualized by the expansion of the fluid bag, as can be seen in Figure 13G. As shown, when the therapeutic agent (341) is injected into the subretinal space, the therapeutic agent (341) is substantially mixed with the fluid of the guide bubble (340).

[0086] Once delivery is complete, the needle (150) can be retracted by rotating the knob (120) in the opposite direction to the direction used to propel the needle (150); and then the cannula (130) can be withdrawn from the eye (301). Due to the size of the needle (150), the site where the needle (150) penetrates the choroid (306) is self-sealing, eliminating the need for further steps to seal the delivery site through the choroid (306). The suture loop assembly (332) and the chandelier (314) can be removed, and the incision in the sclera (304) can be closed using any suitable conventional technique.

[0087] As described above, the aforementioned surgical procedure can be performed to treat patients with macular degeneration. In some such cases, the therapeutic agent (341) delivered by the needle (150) may contain cells derived from the postpartum umbilical cord and placenta. As described above, and by way of example only, the therapeutic agent (341) may be provided in accordance with at least some of the teachings of U.S. Patent No. 7,413,734, the disclosure of which is incorporated herein by reference in its entirety. Alternatively, the needle (150) may be used to deliver one or more other suitable substances in addition to or in place of the substances described in U.S. Patent No. 7,413,734 and / or elsewhere herein. By way of example only, the therapeutic agent (341) may include a variety of pharmaceuticals, including but not limited to small molecules, macromolecules, cell and / or gene therapies. It should also be understood that macular degeneration is merely one illustrative example of a condition that can be treated by the surgical procedure described herein. Other biological conditions that can be addressed using the instruments and surgical procedures described herein will be apparent to those skilled in the art.

[0088] The surgical procedure described above can be performed according to any of the following teachings: U.S. Patent No. 10,226,379, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,949,874, entitled “Therapeutic Agent Delivery Device with Convergent Lumen,” published April 24, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 9,925,088, entitled “Sub-Retinal Tangential Needle Catheter Guide and Introducer,” published March 27, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,322,028, entitled “Method and Apparatus for Sensing Position Between Layers of an Eye,” published June 18, 2019, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 10,322,028, entitled “Motorized Suprachoroidal Injection,” published September 4, 2018. U.S. Patent No. 10,064,752, entitled “Therapeutic Agent,” the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,219,936, entitled “Therapeutic Agent Delivery Device with Advanceable Cannula and Needle,” published March 5, 2019, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,258,502, entitled “Therapeutic Agent Delivery Device,” published April 16, 2019, the disclosure of which is incorporated herein by reference in its entirety; and / or International Publication No. WO 2022 / 136913, entitled “Ocular Cannula Guide,” published June 30, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0089] III. Examples of alternative devices with integrated controls and knob torque loops

[0090] In some cases, it may be desirable to provide one or more features to the rotary knob (120) that are configured to resist rotation of the rotary knob (120), such that the rotary knob (120) can rotate only in response to a predetermined threshold rotational force (e.g., torque) applied to the rotary knob (120) sufficient to overcome the rotational resistance applied by these one or more features. It should be understood that such rotational resistance can suppress accidental rotation of the rotary knob (120) (and thus suppress accidental advance and / or retraction of the needle (150) that would otherwise occur during manipulation of the instrument (100) by a surgeon or other operator (such as in the case of an operator accidentally bumping the rotary knob (120)). Alternatively or additionally, the predetermined threshold rotational force required to overcome such rotational resistance can provide consistency and predictability in the manner in which the rotation of the rotary knob (120) is achieved.

[0091] In some cases, it may be desirable to provide the circuit board assembly (170) with additional features for controlling and / or monitoring the operation of the device (100). Alternatively or additionally, it may be desirable to operatively connect the device (100) to a compact fluid control unit configured to send and receive signals to and from the circuit board assembly (170), and further configured to provide bubble fluid (340) and / or therapeutic agent (341) to the needle (150).

[0092] Figures 14 through 22C illustrate examples of an instrument (400) that can provide the features and functionality described above. The instrument (400) is similar to the instrument (100) described above, unless otherwise described below. In this respect, the instrument (400) is configured for use in surgery to administer a therapeutic agent to the subretinal region of a patient's eye via a suprachoroidal route. The instrument (400) includes a body (410), a pair of buttons (412, 414), a rotary knob assembly (420), and a flexible cannula (430) extending distally from the body (410) to a distal end (432). Also as shown in Figure 14, a cannula assembly (440) extends proximally from the instrument (400). The cannula (430) is typically configured to support a needle (not shown), such as a needle (150), which can slide within the cannula (430), as described in more detail above. In this respect, the device (400) further includes a needle actuator (416) having a cam follower column (418), similar to the needle actuator (180) and the cam follower column (184), unless otherwise described below.

[0093] The rotary knob assembly (420) is rotatable relative to the body (410) to selectively translate the needle (150) longitudinally relative to the cannula (430). Specifically, the rotary knob assembly (420) is rotatable in a first angular direction to drive the needle (150) distally relative to the cannula (430), and rotatable in a second angular direction to drive the needle (150) proximally relative to the cannula (430). In this regard, and as shown in Figure 16, the rotary knob assembly (420) of this example includes: a rotary knob body (421); a knob grip (422) fixedly fastened to the outside of the knob body (421) to facilitate manual rotation of the knob body (421) by an operator; a knob base (423) having a helical cam recess (424) on its underside (Figure 20); a fastener in the form of a bolt or screw (425) for rotatably connecting the knob body (421) to the knob base (423) and defining the axis of rotation (RA) of the rotary knob assembly (420) (Figure 16); a knob cap (426) removably fastened to the knob body (421) to conceal the screw (425); a torque ring (427) fixedly fastened to the inside of the knob body (421); and a slip clutch (428). A torque limiter in the form of a knob body (421) is configured to selectively transmit rotational motion from the knob body (421) to the knob base (423) to facilitate the actuation of the pin (150); and a compression spring in the form of a coil spring (429) is inserted between the knob body (421) and the clutch (428) to resiliently bias the clutch (428) toward the knob base (423) (e.g., downward).

[0094] As shown in Figures 14 to 17, the knob body (421) of this example includes a radially outer wall (450), a radially inner wall (452), and a radially intermediate wall (454). Any or more of the walls (450, 452, 454) may be generally cylindrical and / or generally truncated conical. In the example shown, the inner wall (452) defines a central hole (456) which is sized and configured to rotatably receive a portion of the knob base (423), as described in more detail below. As shown, a plurality of fins (458) extend radially outward from the outer surface of the inner wall (452) and are circumferentially spaced from each other at equal intervals, and a plurality of posts (459) extend at least partially radially inward from the inner surface of the intermediate wall (454) and are circumferentially spaced from each other at equal intervals. As described in more detail below, the fins (458) and / or posts (459) can be configured to interlock with corresponding portions of other parts of the knob assembly (420) to secure these other parts and prevent rotation relative to the knob body (421). Although three fins (458) and three posts (459) are shown in this example, it should be understood that any suitable number of fins (458) and / or posts (459) can be provided.

[0095] As shown in Figures 16 and 18, the torque ring (427) of this example includes an annular wall (460) having an outer surface configured to face and / or frictionally engage the inner surface of a middle wall (454) of a knob body (421). As shown, a plurality of upward-facing recesses (462) extend downward from the upper surface of the annular wall (460) and are circumferentially spaced apart at equal intervals to receive corresponding posts (459) of the knob body (421), while the outer surface of the annular wall (460) faces the inner surface of the middle wall (454). In this way, the recess (462) and the post (459) can be configured to interlock with each other to fix the torque ring (427) to prevent rotation relative to the knob body (421), such that the torque ring (427) can rotate together with the knob body (421) about the axis of rotation (RA) relative to the body (410) of the instrument (100). Although three recesses (462) are shown in this example, it should be understood that any suitable number of recesses (462) can be provided. As shown, a plurality of protrusions (464) extend radially outward from the outer surface of the annular wall (460) at or near the lower end of the annular wall (460) and have corresponding upper surfaces for facing the lower surface of the intermediate wall (454) of the knob body (421), while the outer surface of the annular wall (460) faces the inner surface of the intermediate wall (454) of the knob body (421) and the recess (462) receives the corresponding post (459) of the knob body (421).

[0096] In the example shown, multiple pairs of downward-facing recesses (466) extend upward from the lower surface of the annular wall (460), wherein each pair of recesses (466) is spaced apart from each other to define a corresponding deflectable member in the form of a deflectable beam (468), which are circumferentially spaced apart from each other at equal intervals. As described in more detail below, a stop (469) extends radially outward from the outer surface of each deflectable beam (468) to serve as a part of the body (410) of the frictionally engaging device (400). In this respect, each deflectable beam (468) is configured to deflect radially inward from the undeflected state shown to a corresponding deflected state (not shown) and is elastically biased to present the corresponding undeflected state. Although three pairs of recesses (466) are shown in this example to define three deflectable beams (468), it should be understood that any suitable number of pairs of recesses (466) can be provided to define any suitable number of deflectable beams (468).

[0097] As shown in Figures 16 and 19, the clutch (428) of this example includes an annular wall (470) having an inner surface configured to face the outer surface of the inner wall (452) of the knob body (421). As shown, a plurality of upward-facing recesses (472) extend downward from the upper surface of the annular wall (470) and are circumferentially spaced apart at equal intervals to receive corresponding fins (458) of the knob body (421), while the inner surface of the annular wall (470) faces the outer surface of the inner wall (452). In this way, the recess (472) and the fin (458) can be configured to interlock with each other to fix the clutch (428) to prevent rotation relative to the knob body (421), such that the clutch (428) can rotate together with the knob body (421) about the axis of rotation (RA) relative to the body (410) of the instrument (100). Although three recesses (472) are shown in this example, it should be understood that any suitable number of recesses (472) can be provided.

[0098] In the example shown, the annular plate (474) extends radially outward from the outer surface of the annular wall (470) at or near the lower end of the annular wall (470). As shown, a plurality of generally triangular teeth (476) extend downward from the lower surface of the annular plate (474) and are circumferentially spaced from each other at equal intervals for selectively engaging corresponding portions of the knob base (423). Each tooth (476) may be defined by a pair of beveled surfaces that extend downward from the lower surface of the annular plate (474) and converge at their respective apexes. Although three teeth (476) are shown in this example, it should be understood that any suitable number of teeth (476) may be provided. As shown, a plurality of protrusions (478) extend radially inward from the inner surface of the annular plate (474) and are circumferentially spaced from each other at equal intervals. The protrusions (478) together define a central receiving portion (479), which is sized and configured to rotatably receive part of the knob base (423), as described in more detail below. Although three protrusions (478) are shown in this example, it should be understood that any suitable number of protrusions (478) may be provided.

[0099] As shown in Figures 16 and 20, the knob base (423) includes a central hub (480) configured to be received within a central receiving portion (479) of the clutch (428) and a central bore (456) of the knob body (421). In this respect, the central hub (480) has an outer surface configured to face the inner surface of the inner wall (452) of the knob body (421) and the inner surface of the protrusion (478) of the clutch (428). In the illustrated example, the central hub (480) defines a central threaded bore (482) sized and configured to receive a screw (425) for rotatably connecting the knob body (421) to the knob base (423).

[0100] In the example shown, an annular plate (484) extends radially outward from the outer surface of the central hub (480) at or near the lower end of the central hub (480), wherein a helical cam recess (424) is formed by the lower surface of the annular plate (484). As best shown in Figure 16, a circumferential array of generally triangular grooves (486) extends downward from the upper surface of the annular plate (484) for selectively engaging the teeth (476) of the clutch (428). Each groove (486) may be defined by a pair of beveled surfaces that extend downward from the upper surface of the annular plate (484) and converge at their respective vertices. In this way, the groove (486) and the tooth (476) can be configured to selectively interlock with each other to fix the knob base (423) to prevent rotation relative to the clutch (428) and thus to prevent rotation relative to the knob body (421), so that the knob base (423) together with the knob body (421) can rotate about the axis of rotation (RA) relative to the body (410) of the instrument (400).

[0101] A helical cam recess (424) is configured and operable similarly to the helical cam recess (124) described above, for converting rotation of the knob base (423) about the axis of rotation (RA) into longitudinal translation of the needle (150), such as via the cam follower (418) of the needle actuator (416). In this respect, and as shown in Figures 21A to 21B, the cam follower (418) of the needle actuator (416) is configured to fit precisely into the helical cam recess (424) of the knob base (423). Due to this engagement, the needle actuator (416) will respond to rotation of the knob base (423) from a proximal position (Figure 21A) to a distal position (Figure 21B). Figure 21B Translation.

[0102] As shown in Figures 21A and 21B, the stop (469) of the deflectable beam (468) of the torque ring (427) is configured to frictionally engage the inner annular protrusion (490) of the body (410) of the device (400). In this respect, the annular protrusion (490) can be configured to push the deflectable beam (468) toward a corresponding deflection state at least slightly radially inward via the corresponding stop (469). Due to the elastic bias of the deflectable beam (468) toward its corresponding undeflected state, the deflectable beam (468) can remain frictionally engaged with the annular protrusion (490) to generate a predetermined amount of friction that prevents the torque ring (427) and thus the knob body (421) and knob base (423) from rotating about the axis of rotation (RA) relative to the body (410) of the device (400). In this way, the deflectable beam (468) of the torque ring (427) can resist the rotation of the knob body (421) and the knob base (423), so that the knob body (421) and the knob base (423) can rotate about the rotation axis (RA) only in response to the application of a predetermined threshold rotational force to the knob body (421) sufficient to overcome the rotational resistance applied by the deflectable beam (468).

[0103] As noted above, the rotational resistance provided by the torque ring (427) can suppress unintended rotation of the knob body (421) and knob base (423) (and thus suppress unintended forward and / or retraction of the needle (150) that might otherwise occur during the manipulation of the instrument (400) by a surgeon or other operator). Alternatively or additionally, a predetermined threshold rotational force required to overcome such rotational resistance can provide consistency and predictability in how the knob body (421) and knob base (423) are rotated. In some versions, the predetermined threshold rotational force can range from approximately 25 ounces to approximately 50 ounces. It should be understood that the predetermined threshold rotational force can be adjusted based on a variety of factors, such as the length and / or cross-sectional thickness of the deflectable beam (468), the size of the stop (469), and / or the material of the torque ring (427).

[0104] Although the deflectable beam (468) of this example is incorporated into the torque ring (427) and abuts against the body (410) of the instrument (400), it should be understood that the deflectable beam (468) or any other suitable type of deflectable member may alternatively be incorporated into the body (410) of the instrument (400) and abut against the knob body (420) of the knob assembly (420) or any other suitable portion to provide desired rotational resistance, such as the reverse arrangement shown. For example, the torque ring (427) may be fixed to prevent rotation relative to the body (410) of the instrument (400), and the stop (469) of the deflectable beam (468) may be configured to frictionally engage the surface of the knob body (420). In some versions, the torque ring (427) may be integrally formed as a single unit (e.g., monolithic) part together with the body (410) of the instrument (400) or the knob body (421).

[0105] In addition to being configured to selectively interlock with each other to fix the knob base (423) to prevent rotation relative to the knob body (421), the groove (486) of the knob base (423) and the teeth (476) of the clutch (428) can also be configured to selectively disengage from each other to allow relative rotation (e.g., slippage) between the knob base (423) and the clutch (428) and thus between the knob base (423) and the knob body (421), such that the knob base (423) can, in some cases, remain stationary about the axis of rotation (RA) during rotation of the knob body (421) relative to the body (410) of the instrument (400) about the axis of rotation (RA). In this respect, the coil spring (429) is vertically inserted between the downward-facing surface of the knob body (421) and the upper surface of the annular plate (474) of the clutch (428), and radially inserted between one or both of the inner surface of the annular wall (460) of the torque ring (427) and the outer surface of the inner wall (452) of the knob body (421) and / or the outer surface of the annular wall (470) of the clutch (428). The coil spring (429) is configured to resiliently bias the clutch (428) downward toward the knob base (423), such that the teeth (476) of the clutch (428) are resiliently biased by the coil spring (429) to engage with the slots (486) of the knob base (423). Thus, the tooth (476) can be configured to engage with the slot (486) via the coil spring (429) without applying a threshold upward guiding force to the clutch (428) sufficient to overcome the downward bias of the coil spring (429) on the tooth (476).

[0106] In some versions, the threshold upward guiding force used to overcome the downward bias of the coil spring (429) on the tooth (476) can be generated by rotating the knob body (421) in a first angular direction when the needle (150) is already in its farthest position relative to the cannula (430), or by rotating the knob body in a second angular direction when the needle (150) is already in its closest position relative to the cannula (430). In these cases, rotation of the knob base (423) in the same angular direction as the rotation of the knob body (421) can be suppressed (e.g., due to the interaction between the end of the helical cam recess (424) and the cam follower (418) of the needle actuator (416), so that the slot (486) can resist the rotation of the tooth (476). Therefore, the knob base (423) can be configured to apply a threshold upward guiding force to the clutch (428) via the cam interaction between the angled surface of the slot (486) and the angled surface of the tooth (476) to push the tooth (476) upward away from the slot (486), so that the knob body (421) can slide relative to the knob base (423) and thereby prevent mechanical overload of the knob base (423).

[0107] As shown in Figures 22A to 22C, the instrument (400) of this example includes a fluid supply assembly (500) at least partially held within a chamber (505) of a needle actuator (416). In the illustrated example, a retaining pin (507) is received by a pair of opposing holes (not shown) disposed in the needle actuator (416) for retaining various components of the fluid supply assembly (500) within the chamber (505).

[0108] The fluid supply assembly (500) of this example includes a first fluid supply tube and a second fluid supply tube (511a, 511b), a fluid supply connector (512), a first self-actuating check valve and a second self-actuating check valve (513a, 513b), and a valve retainer (514). In the example shown, each fluid supply tube (511a, 511b) extends between an open proximal end (not shown) and an open distal end (516a, 516b) and defines an inner lumen (517a, 517b) extending therebetween for guiding fluid through it. The open proximal end of each fluid supply tube (511a, 511b) is fluidly connected to a corresponding fluid conduit of the tube assembly (440), and each open distal end (516a, 516b) is fluidly connected to the fluid supply connector (512), as described in more detail below.

[0109] As shown, the fluid supply connector (512) and the valve retainer (514) are each fixedly held within the chamber (505) of the needle actuator (416). More specifically, a retaining pin (507) engages the fluid supply connector (512) and the valve retainer (514) within the chamber (505). Thus, the fluid supply connector (512) and the valve retainer (514), together with the needle actuator (416) (and therefore with the needle (150)), can be longitudinally translated relative to the body (410) of the instrument (400). The fluid supply connector (512) of this example includes a first proximal fluid supply channel and a second proximal fluid supply channel (518a, 518b), which are fluidly isolated from each other and configured to be fluidly connected to the open distal ends (516a, 516b) of the first and second fluid supply pipes (511a, 511b), respectively. In the illustrated example, the fluid supply connector (512) includes a first generally annular valve seat and a second generally annular valve seat (519a, 519b) defined around the open distal ends of the respective fluid supply channels (518a, 518b) and angled relative to each other to define a “V” shape, the purpose of which is described below. As shown, a generally elongated groove (520) extends radially inward from the radially outer surface of the fluid supply connector (512), and a proximal washer in the form of a generally elongated O-ring (521) is disposed in the groove (520) to provide a liquid-tight seal between the fluid supply connector (512) and one side of the chamber (505).

[0110] The valve retainer (514) of this example includes a single distal fluid supply channel (522) fluidly coupled to the lumen of the needle (150) via, for example, through the orifice (507) of the needle actuator (416), and configured to selectively fluidly coupled to a first proximal fluid supply channel and a second proximal fluid supply channel (518a, 518b) of the fluid supply connector (512). In this respect, the valve retainer (514) also includes a first generally dome-shaped recess and a second generally dome-shaped recess (523a, 523b) configured to face the first valve seat and the second valve seat (519a, 519b), respectively, to define the first and second fluid channels (524a, 524b) therebetween. As shown, a generally circular groove (525) extends from the distal surface of the valve retainer (514) to the proximal surface, and a distal gasket in the form of a generally circular O-ring (526) is disposed within the groove (525) to provide a liquid-tight seal between the valve retainer (514) and the distal end of the chamber (505).

[0111] As shown in the figure, each fluid gateway (524a, 524b) is configured to selectively fluidly connect the corresponding proximal fluid supply channel (518a, 518b) to the distal fluid supply channel (522) to selectively guide fluid from the corresponding proximal fluid supply channel (518a, 518b) through the corresponding fluid gateway (524a, 524b) to the distal fluid supply channel (522). In this regard, a corresponding portion of each valve (513a, 513b) is at least partially disposed within each fluid passage (524a, 524b) for selectively placing the corresponding proximal fluid supply channel (518a, 518b) in fluid communication or not in fluid communication with the distal fluid supply channel (522). For this purpose, the valve retainer (514) may include a first valve retention slot and a second valve retention slot; and each valve (513a, 513b) includes a generally truncated conical rod (528a, 528b) that can be fixedly received within the corresponding valve retention slot and a generally disc-shaped flexible diaphragm (529a, 529b). In some versions, a fluid supply connector (512) may capture the rod (528a, 528b) within the corresponding valve retention slot. Each disc-shaped diaphragm (529a, 529b) is flexibly coupled to the corresponding rod (528a, 528b) (e.g., via a corresponding movable hinge) such that each diaphragm (529a, 529b) can bend between a corresponding open and closed state.

[0112] More specifically, the membrane (529a) of the first valve (513a) is bendable between a closed state (Figures 22A and 22C) and an open state (Figure 22B). In the closed state, the membrane (529a) sealably engages the first valve seat (519a) of the fluid supply connector (512) to prevent fluid from flowing from the first proximal fluid supply channel (518a) through the first fluid gateway (524a) to the distal fluid supply channel (522). In the open state, the membrane (529a) disengages from the first valve seat (519a) of the fluid supply connector (512) to allow fluid to flow from the first proximal fluid supply channel (518a) through the first fluid gateway (524a) to the distal fluid supply channel (522). Similarly, the membrane (529b) of the second valve (513b) is bendable between a closed state (Figures 22A and 22B) and an open state (Figure 22C). In the closed state, the membrane (529b) sealably engages the second valve seat (519b) of the fluid supply connector (512) to prevent fluid from flowing from the second proximal fluid supply channel (518b) through the second fluid gateway 524b to the distal fluid supply channel (522). In the open state, the membrane (529b) disengages from the second valve seat (519b) of the fluid supply connector (512) to allow fluid to flow from the second proximal fluid supply channel (518b) through the second fluid gateway 524b to the distal fluid supply channel (522).

[0113] Each membrane (529a, 529b) in this example is elastically biased to present a corresponding closed state and configured to bend toward a corresponding open state in response to a threshold downstream directional force applied to the corresponding membrane (529a, 529b). This may be due to the presence of a threshold fluid pressure within the corresponding proximal fluid supply channel (518a, 518b). For example, each membrane (529a, 529b) may be configured to immediately bend toward the corresponding open state in response to the fluid pressure within the corresponding proximal fluid supply channel (518a, 518b) reaching a threshold fluid pressure to allow fluid to flow therein in a downstream direction, and may be configured to immediately elastically return to the corresponding closed state in response to the fluid pressure within the corresponding proximal fluid supply channel (518a, 518b) dropping downwards to prevent fluid backflow in a upstream direction. In this regard, each valve (513a, 513b) may comprise an elastomeric material, such as silicone. In some versions, each valve (513a, 513b) is configured as a Bass valve, such as the type sold by Minivalve International of Oldenza, Netherlands, or from any other suitable source. Alternatively or concurrently, each valve (513a, 513b) may be configured and operated in accordance with one or more of the teachings of EP 1953432 entitled “Fluid Control Valves”, authorized on 12 April 2017.

[0114] As shown in Figure 22B, when the membrane (529a) of the first valve (513a) is in the corresponding open state and the membrane (529b) of the second valve (513b) is in the corresponding closed state, the bubble fluid (340) can flow from the corresponding fluid conduit of the tubing assembly (440), through the first lumen (517a) of the first fluid supply tube (511a), through the first proximal fluid supply channel (518a) of the fluid supply connector (512), through the first fluid gateway (524a), through the distal fluid supply channel (522) of the valve retainer (514), and into the lumen of the needle (150) for delivery at the distal tip (152). Due to the closure of the membrane (529b) of the second valve (513b), the therapeutic fluid (341) can remain substantially isolated from the foam fluid (340) within the device (400) during the delivery of the foam fluid (340).

[0115] As shown in Figure 22C, when the membrane (529b) of the second valve (513b) is in the corresponding open state and the membrane (529a) of the first valve (513a) is in the corresponding closed state, the therapeutic fluid (341) can flow from the corresponding fluid conduit of the tubing assembly (440), through the second lumen (517b) of the second fluid supply tube (511b), through the second proximal fluid supply channel (518b) of the fluid supply connector (512), through the second fluid gateway (524b), through the distal fluid supply channel (522) of the valve retainer (514), and into the lumen of the needle (150) for delivery at the distal tip (152). Due to the closure of the membrane (529a) of the first valve (513a), the bubble fluid (340) can remain substantially isolated from the therapeutic fluid (341) within the device (400) during the delivery of the therapeutic fluid (341).

[0116] It should be understood that the proximal O-ring (521) can help prevent fluid flowing through either fluid supply gateway (524a, 524b) from leaking proximally from the chamber (505) of the needle actuator (416), and the distal O-ring (526) can help prevent fluid flowing between the distal fluid supply channel (522) and the lumen of the needle (150) from leaking laterally toward the chamber (505) of the needle actuator (416).

[0117] Although a Bass valve (513a, 513b) is used in this example, any other suitable type of valve, such as an umbrella valve, may be used. Other suitable ways in which the valve can be incorporated into the device (400) in light of the teachings herein will be apparent to those skilled in the art. For example, the device (400) may include an integral valve assembly configured and operated in accordance with at least some of the teachings of U.S. Patent No. 10,226,379, entitled “Method and Apparatus for Subretinal Delivery of a Therapeutic Agent,” published March 12, 2019, the disclosure of which is incorporated herein by reference.

[0118] For example only, the fluid supply assembly (500) may be configured and operated in accordance with at least some of the teachings in the international publication entitled “Transvitreal Subretinal Injector”, published on January 18, 2024, WO 2024 / 013559, the contents of which are incorporated herein by reference in their entirety.

[0119] Referring again to Figure 14, the instrument (400) is shown as an example operatively coupled to the fluid control unit (600) via a tubing assembly (440). The fluid control unit (600) can be substantially more compact than a typical vitrectomy machine. For example, the fluid control unit (600) can be configured as a handheld device. The fluid control unit (600) can include a bubble fluid source similar to the bubble fluid source (82) described above and a therapeutic fluid source similar to the therapeutic fluid source (84) described above. The bubble fluid source can be coupled to the bubble fluid conduit of the tubing assembly (440); and the therapeutic fluid source can be coupled to the therapeutic conduit of the tubing assembly (440). These conduits are in fluid communication with the needle (150). The fluid control unit (600) may also include one or more suitable fluid dispensing mechanisms, which may include, for example, one or more syringe plungers, pumps, valves, pneumatic actuators and / or motors configured to selectively dispense bubble fluid (340) and therapeutic agent (341) from respective sources.

[0120] The fluid control unit (600) is operable to automatically dispense bubble fluid (340) and therapeutic agent (341) to the device (400) via tubing (440). More specifically, the fluid control unit (600) may include a processor operatively communicating with the fluid dispensing mechanism and various components of the device (400) to send signals to and / or receive signals from them.

[0121] In this regard, and as shown in FIG23, the device (400) of this example further includes a circuit board assembly (650) similar to a circuit board assembly (170) disposed within the body (410). The upper side of the circuit board assembly (650) may include a first user input element and a second user input element in the form of tactile switches (652, 654), respectively similar to the second tactile switch and the first tactile switch (172) described above. The first tactile switch and the second tactile switch (652, 654) may be positioned relative to corresponding buttons (412, 414) such that an operator can provide actuation of the first tactile switch (652) by pressing the first button (412) and actuation of the second tactile switch (654) by pressing the second button (414). The first and second tactile switches (652, 654) can communicate with the processor of the fluid control unit (600) via one or more wires (not shown) similar to wires (175) contained in the tube assembly (440). By way of example only, the fluid control unit (600) can be configured to provide delivery of bubble fluid (340) via needle (150) in response to actuation of the first tactile switch (652), and / or to provide delivery of therapeutic agent (341) via needle (150) in response to actuation of the second tactile switch (654).

[0122] For example, the fluid control unit (600) may be configured to dispense bubble fluid (340) at a predetermined fixed flow rate when the first tactile switch (652) is actuated (e.g., when the first button (412) is pressed), and may be configured to continuously monitor the volume of bubble fluid (340) delivered via the needle (150), such as based on the fixed flow rate and the duration of the dispensing of bubble fluid (340). The fluid control unit (600) may be configured to (e.g., via digital readout of the fluid control unit (600)) present a text or graphic message indicating the volume of bubble fluid (340) delivered via the needle (150). In this example, the flow rate of the bubble fluid (340) is predetermined. By way of example only, the predetermined flow rate of the bubble fluid (340) may be in the range of approximately 100 µL per minute to approximately 300 µL per minute. For example, the predetermined flow rate of the bubble fluid (340) may be approximately 200 µL per minute. In some other versions, the fluid control unit (600) provides user input, whereby the operator can select to allocate a desired flow rate of the bubble fluid (340) when the first tactile switch (652) is actuated. Alternatively, the flow rate of the bubble fluid (340) can be varied during delivery, such as based on a predetermined flow rate sequence selected by the operator.

[0123] Alternatively or concurrently, the fluid control unit (600) may be configured to dispense a therapeutic agent (341) at a precise fixed flow rate when the second tactile switch (654) is actuated (e.g., when the second button (414) is pressed), and may be configured to continuously monitor the volume of the therapeutic agent (341) delivered via the needle (150), such as based on the fixed flow rate and the duration of the therapeutic agent (341) dispensing. For example, the fluid control unit (600) may be configured to monitor the cumulative volume of the therapeutic agent (341) delivered to the eye (301) via multiple discrete deliveries via the needle (150), such as when the second button (414) is pressed, released, and then pressed again. The fluid control unit (600) may be configured (e.g., via digital readout of the fluid control unit (600)) to present a text or graphic message indicating the volume of the therapeutic agent (341) delivered via the needle (150). In some versions, the fluid control unit (600) provides user input, whereby the operator can select a desired flow rate of the therapeutic agent (341) when the second tactile switch (654) is actuated. Alternatively, the flow rate of the therapeutic agent (341) can vary during delivery, such as based on a predetermined flow rate sequence selected by the operator.

[0124] The upper side of the circuit board assembly (650) may also include a sensor, such as a linear sensor (656) similar to the linear sensor (176) described above, or a rotary sensor such as a rotary potentiometer (not shown). For example, the linear sensor (656) may include a slider configured to slide monolithically with the needle actuator (416) and thereby translate longitudinally relative to the body of the linear sensor (656). The linear sensor (656) may be configured to generate varying data values ​​based on the longitudinal position of the slider along the body of the linear sensor (656). By way of example only, the linear sensor (656) may include a linear potentiometer that generates varying resistance values ​​based on the longitudinal position of the slider along the body. Thus, the resistance value generated by the linear sensor (656) will indicate the longitudinal position of the needle (150) relative to the cannula (430). As just another example, the linear sensor (656) may include a sensor that senses rotation of the knob base (423), an optical sensor, or a sensor located in the instrument (400) to directly monitor movement of the needle actuator (416). Various other suitable methods for sensing movement of the needle (150) will be apparent to those skilled in the art in light of the teachings herein. The linear sensor (656) may communicate with the processor of the fluid control unit (600) via one or more wires (not shown) similar to wires (175) contained in the tubing assembly (440). The fluid control unit (600) may be configured to present text or graphical messages indicating the length and / or longitudinal position of the needle (150) based on one or more signals received by the processor of the fluid control unit (600) from the linear sensor (656), e.g., via digital readouts of the fluid control unit (600). Alternatively or additionally, the fluid control unit (600) may be configured to provide automated delivery of bubble fluid (340) via the needle (150) in response to distal movement of the needle (150) sensed by a linear sensor (656). For example, the fluid control unit (600) may be configured to provide automated delivery of bubble fluid (340) via the needle (150) at a predetermined fixed flow rate as described above during distal advance of the needle (150) to facilitate safe penetration of the distal tip (152) of the needle (150) into the choroid (306) without penetrating the retina (308). Furthermore or additionally, the flow rate for the bubble fluid (340) may vary based on the translational speed of the needle (150). For example, if the needle (150) advances rapidly, the bubble fluid (340) may be delivered at a relatively high rate; and if the needle (150) advances slowly, the bubble fluid (340) may be delivered at a relatively slow rate.

[0125] The upper side of the circuit board assembly (650) may further include at least one user feedback element in the form of a light-emitting element, such as an array of red-green-blue (RGB) programmable LEDs (658). The LEDs (658) may be configured to emit light selectively. A knob assembly (420), buttons (412, 414), and / or a body (410) may be configured to allow the light emitted by the LEDs (658) to be viewed. The LEDs (658) may communicate with the processor of the fluid control unit (600) via one or more wires (not shown) similar to wires (175) contained in the tube assembly (440). The fluid control unit (600) may be configured to cause the LEDs (658) to emit light differently based on specific states of the system defined by the device (400) and the fluid control unit (600). For example, the fluid control unit (600) may be configured to send signals to the LED (658) to: emit yellow light to indicate that the system is being started (e.g., initiation of a delivery line for foam fluid (340) and / or therapeutic agent (341); emit red light to indicate an error within the system (e.g., the system is not ready to deliver foam fluid (340) and / or therapeutic agent (341)); emit green light when the system is started and / or when the needle (150) is in its fully retracted proximal position (e.g., making the cannula (430) ready to be inserted into the eye (301)); and / or emit indigo light when the needle (150) has advanced distally from its fully retracted proximal position. Various other suitable ways of using the LED (658) will be apparent to those skilled in the art in light of the teachings herein.

[0126] The circuit board assembly (650) may also include at least one user feedback element in the form of a speaker (660), which is configured to provide one or more audible tones. The speaker (660) may communicate with the processor of the fluid control unit (600) via one or more wires (not shown) similar to wires (175) contained in the tube assembly (440). The fluid control unit (600) may be configured to provide different audible tones via the speaker (660) based on specific states of the system defined by the device (400) and the fluid control unit (600). For example, the fluid control unit (600) may be configured to send signals to the speaker (660) to: provide a first unique audible or pure tone series to indicate that the needle (150) has advanced distally to its most distal position of full extension; provide a second unique audible or pure tone series during the delivery of the bubble fluid (340); provide a third unique audible or pure tone series (e.g., a countdown) between the actuation of the second tactile switch (654) and the commencement of the dispensing of the therapeutic agent (341) from the fluid control unit (600); provide a fourth unique audible or pure tone series during the delivery of the therapeutic agent (341); a fifth unique audible or pure tone series to indicate that the delivery of the therapeutic agent (341) has been completed; and / or provide a sixth unique audible or pure tone series when the needle (150) is in its most proximal position of full retraction. Various other suitable ways of using the speaker (660) will be apparent to those skilled in the art in light of the teachings herein. Although the speaker (660) has been described as being integrated into the circuit board assembly (650), it should be understood that in some other versions, the speaker (660) may be integrated into the fluid control unit (600).

[0127] By way of example only, the device (400) may provide one or more of these functionalities via a circuit board assembly (650) in accordance with at least some of the teachings of U.S. Patent No. 10,646,374, the disclosure of which is incorporated herein by reference in its entirety.

[0128] IV. Examples of Compact Fluid Control Units

[0129] As noted above, it may be desirable to operatively connect instruments such as any of the instruments (100, 400) described above to a compact fluid control unit configured to send and receive signals to and from the circuit board assembly (170, 650) of the instruments (100, 400), and further configured to provide bubble fluid (340) and / or therapeutic agent (341) to the needle (150) of the instruments (100, 400). Such fluid control units may be substantially more compact and / or substantially lighter than typical vitrectomy machines. For example, such fluid control units may be configured as handheld devices. Alternatively or additionally, such fluid control units may be configured for mounting to a wrist rest (10) or another fixation device, such as a fixation device (14), adjacent to the patient.

[0130] Figures 24 to 35 illustrate examples of a fluid control unit (700) that can provide the features and functionality described above. The fluid control unit (700) is similar to the fluid control unit (600) described above, unless otherwise described below. In the illustrated example, the fluid control unit (700) includes a control module (702) and a cartridge (704) configured to hold a bubble fluid source in the form of a first syringe (706a) and a therapeutic fluid source in the form of a second syringe (706b). Although the first and second syringes (706a, 706b) are described as a bubble fluid source and a therapeutic fluid source, respectively, it should be understood that the first syringe (706a) may alternatively be a therapeutic fluid source and / or the second syringe (706b) may alternatively be a bubble fluid source. For example, the syringes (706a, 706b) may each have a capacity of approximately 500 µL. The box (704) is further configured to be removably coupled to the control module (702) while holding the syringes (706a, 706b) to define the loaded state of the fluid control unit (700).

[0131] As described in more detail below, the fluid control unit (700) can be operatively connected to an instrument, such as an instrument (100, 400), via a corresponding tubing assembly (140, 440), and can be operatively operated to automatically dispense bubble fluid (340) and therapeutic agent (341) from a syringe (706a, 706b) to the instrument (100, 400) via a fluid conduit (142, 144) in fluid communication with the needle (150) of the instrument (100, 400). As described in more detail below, the fluid control unit (700) can communicate with the instruments (100, 400) via one or more wires (175) operatively communicating with the circuit board assembly (170, 650) of the tubing group (140, 440) and can communicate wirelessly and / or via one or more wires (708) with an off-board processor (707) (e.g., a host computer).

[0132] Figure 24 shows a fluid control unit (700) mounted to a wrist rest (10) such that the wrist rest (10) substantially bears the weight of the fluid control unit (700). In this respect, the fluid control unit (700) of this example has a substantially lightweight configuration, wherein the fluid control unit (700) has such a small total weight that the wrist rest (10) can substantially bear the total weight of the fluid control unit (700) without the risk of the fluid control unit (700) overburdening the wrist rest (10). The fluid control unit (700) of this example also has a substantially compact configuration such that when the fluid control unit (700) is mounted to the wrist rest (10), the fluid control unit (700) can perform the surgery described above without interfering with the operator. For example, the fluid control unit (700) can have a total physical volume of less than about 150 mL (e.g., defined by the control module (702), the box (704), and the syringes (706a, 706b). In other words, the fluid control unit (700) can be assembled in a three-dimensional space with a volume of less than about 150 mL.

[0133] The fluid control unit (700) can be mounted to the armrest (10) in any suitable manner, such as via a mounting assembly (701) including a bracket (703) and / or a clamp (705). For example, Figure 24A shows the fluid control unit (700) positioned on and at least partially received within a bracket (703), and the bracket (703) is shown as removably coupled to the armrest (10) via a clamp (705). The clamp (705) can be adjustable to facilitate attachment of the mounting assembly (701) to various different armrests (10) having a predetermined range of diameters. For example, the clamp (705) can be compatible with armrests (10) having diameters ranging from about 25 mm to about 30 mm. Although the fluid control unit (700) in this example is shown mounted to the wrist rest (10), the substantially compact and lightweight configuration of the fluid control unit (700) allows it to be supported by a variety of other objects and / or people during surgery. For example, the fluid control unit (700) can be easily mounted to the fixation device (14) described above. As another example, the fluid control unit (700) can be held by the surgeon or other operator during surgery. Therefore, unlike a typical vitrectomy machine, the fluid control unit (700) does not need to be positioned on the floor, or even on a table (although these positioning options can still be utilized if needed).

[0134] As shown in Figures 24 to 31, the control module (702) of this example includes a housing (710) and various components contained within the housing (710), including a circuit board assembly (711), a power supply in the form of a battery (712), and a first drive assembly and a second drive assembly (713a, 713b) for facilitating the dispensing of fluid (340, 341) from a first syringe and a second syringe (706a, 706b), respectively. In the example shown, the housing (710) is defined by an upper housing and a lower housing (714, 715), wherein the circuit board assembly (711) is fixed to the lower housing (715), and wherein the battery (712) and the drive assembly (713a, 713b) are fixed to the upper housing (714). However, it should be understood that the housing (710) may be defined in any other suitable manner, and the circuit board assembly (711), the battery (712), and the drive assembly (713a, 713b) may be fixed to the housing (710) in any other suitable manner.

[0135] Referring primarily to Figures 25 to 28, in the illustrated example, the upper housing (714) of the outer casing (710) includes a top wall (716) configured to support the battery (712) and drive assemblies (713a, 713b), and further includes a proximal sidewall (717), a distal sidewall (718), and first and second sidewalls (719a, 719b) each extending generally downward from the top wall (716). The upper housing (714) of this example further includes a first generally U-shaped syringe receiving portion and a second generally U-shaped syringe receiving portion (720a, 720b) ​​extending both downward from the upper surface of the top wall (716) and proximal from the distal surface of the distal sidewall (718). The first syringe receiving portion and the second syringe receiving portion (720a, 720b) ​​are sized and configured to at least partially receive the first syringe and the second syringe (706a, 706b) respectively when the housing (704) is removably coupled to the control module (702). In the illustrated example, the first syringe receiving portion and the second syringe receiving portion (720a, 720b) ​​terminate proximally at a first proximal recessed wall and a second proximal recessed wall (721a, 721b) of the upper housing (714). A first hole and a second hole (722a, 722b) extend through the first proximal recessed wall and the second proximal recessed wall (721a, 721b) respectively to allow corresponding portions of the first drive assembly and the second drive assembly (713a, 713b) to enter the syringe (706a, 706b) received in the corresponding syringe receiving portion (720a, 720b).

[0136] The upper housing (714) of this example further includes a first connecting member and a second connecting member in the form of orifices (723a, 723b), the first connecting member and the second connecting member extending laterally outward from the first receiving portion and the second receiving portion (720a, 720b) ​​through the distal sidewall (718), respectively, and configured to interact with corresponding portions of the box (704) to removably connect the box (704) to the control module (702). The upper housing (714) of this example further includes an expansion dock (724) extending proximally from the distal sidewall (718) and configured to support the box (704) when the box (704) is removably connected to the control module (702). More specifically, the docking station (724) includes a first lower platform and a second lower platform (725a, 725b) extending distally from a portion of the distal wall (718) substantially below the respective syringe receivers (720a, 720b) ​​and configured to face the syringes (706a, 706b) received within the respective syringe receivers (720a, 720b). A first elongated slot and a second elongated slot (726a, 726b) extend through the first lower platform and the second lower platform (725a, 725b), respectively, for transmitting light from the circuit board assembly (711) to the syringes (706a, 706b) received within the respective syringe receivers (720a, 720b). In some versions, a transparent window (not shown) may be positioned within an elongated slot (726a, 726b) to protect the circuit board assembly (711) from fluid spills or other environmental hazards.

[0137] In the illustrated example, the docking station (724) further includes a raised central platform (727) that extends distally from the distal sidewall (718) and bridges between the lower platforms (725a, 725b). An array of holes (728) extends through the raised central platform (727) to allow corresponding portions of the circuit board assembly (711) into the housing (704). The docking station (724) further includes a first guide member and a second guide member in the form of tracks (729a, 729b) that extend laterally outward from the corresponding sides of the raised central platform (727) above the first and second lower platforms (725a, 725b) to define a first recess and a second recess (730a, 730b), respectively. The tracks (729a, 729b) and grooves (730a, 730b) are configured to interact with corresponding portions of the box (704) to guide the box (704) to proper alignment with the control module (702) during connection of the box (704) to the control module (702).

[0138] The upper housing (714) of this example further includes a pair of holes (731, 732) extending through the top wall (716) and configured to receive a start button (733) and a light guide (734), respectively. The start button (733) extends downward through the interior of the housing (710) to the circuit board assembly (711) and is configured to be selectively pressed by an operator. The light guide (734) also extends downward through the interior of the housing (710) to the circuit board assembly (711) for transmitting light from the circuit board assembly (711) through the top wall (716) of the housing (710).

[0139] In the illustrated example, the lower housing (715) of the housing (710) includes a bottom wall (735) configured to support the circuit board assembly (711), and further includes a proximal sidewall (736), a distal sidewall (737), and first and second sidewalls (738a, 738b) each extending generally upward from the bottom wall (735). The lower housing (715) of this example further includes a pair of proximal recesses (739, 740) extending downward from the upper surface of the proximal sidewall (736) and a distal recess (741) extending downward from the upper surface of the distal sidewall (737). The recesses (739, 740, 741) are configured to allow access to corresponding portions of the circuit board assembly (711).

[0140] Referring now primarily to Figures 28 to 30, the first and second drive assemblies (713a, 713b) of this example include a first linear actuator and a second linear actuator (742a, 742b), which are configured to be independently driven by a first electric motor and a second electric motor (743a, 743b) to dispense fluid (340, 341) from a first injector and a second injector (706a, 706b), respectively, when the cartridge (704) is removably connected to the control module (702). In the illustrated example, the linear actuators (742a, 742b) and the corresponding motors (743a, 743b) are supported by corresponding frames (744a, 744b), which are securely fastened to the lower surface of the top wall (716) of the housing (710) via corresponding fasteners in the form of screws (745). The frame (744a, 744b) of this example accordingly includes: generally horizontally extending drive support plates (746a, 746b) which are fixedly fastened to the top wall (716) by corresponding screws (745); and a pair of generally vertically extending drive support frames (747a, 747b, 748a, 748b) which are fixedly fastened to the distal ends of the respective drive support plates (746a, 746b) by corresponding fasteners in the form of screws (749) and spaced apart from each other by corresponding press-fit studs (750). In the example shown, each pair of drive support frames (747a, 747b, 748a, 748b) holds a corresponding pair of bushings (751a, 751b) to movably support the respective linear actuators (742a, 742b).

[0141] The first and second linear actuators (742a, 742b) of this example include a first lead screw and a second lead screw (752a, 752b), which are respectively supported translationally by a first pair of bushings and a second pair of bushings (751a, 751b), such that the lead screws (752a, 752b) are respectively configured to translate relative to the respective frames (744a, 744b) along the respective longitudinal axes (LA1, LA2). In this regard, each lead screw (752a, 752b) in the illustrated example includes a flat key surface (753a, 753b) configured to interact with one or both of the corresponding bushings (751a, 751b) to inhibit rotation of the lead screw (752a, 752b) about the corresponding longitudinal axis (LA1, LA2), while allowing translation of the lead screw (752a, 752b) along the corresponding longitudinal axis (LA1, LA2). In the illustrated example, the first and second longitudinal axes (LA1, LA2) are substantially parallel to each other, which contributes to a substantially compact configuration of the fluid control unit (700). The first and second holes (722a, 722b) of the housing (710) are aligned with the first and second lead screws (752a, 752b) along their respective longitudinal axes (LA1, LA2) to allow the lead screws (752a, 752b) to enter the syringes (706a, 706b) received within their respective syringe receivers (720a, 720b). In the illustrated example, the first and second plunger caps (754a, 754b) are coupled to the distal ends of the first and second lead screws (752a, 752b) for dispensing fluid (340, 341) from the first and second syringes (706a, 706b) respectively during translation of the respective lead screws (752a, 752b) along their respective longitudinal axes (LA1, LA2).

[0142] The first and second linear actuators (742a, 742b) of this example further include a first gear and a second gear (755a, 755b), which are rotatably supported by a first pair of bushings and a second pair of bushings (751a, 751b) and / or by a first lead screw and a second lead screw (752a, 752b), such that the gears (755a, 755b) are respectively configured to rotate relative to the respective frames (744a, 744b), and thus rotate about the respective longitudinal axes (LA1, LA2) relative to the respective lead screws (752a, 752b). In this respect, each gear (755a, 755b) may include a threaded center hole that screwably engages with a corresponding lead screw (752a, 752b), such that each lead screw (752a, 752b) is configured to translate along the corresponding longitudinal axis (LA1, LA2) in response to rotation of the corresponding gear (755a, 755b) about the corresponding longitudinal axis (LA1, LA2). In other words, each gear (755a, 755b) can effectively define the lead nut of the corresponding linear actuator (742a, 742b). In some other versions, each gear (755a, 755b) may include a threadless center hole that holds a separate lead nut (not shown) fixedly, and the separate lead nut may include a threaded center hole that screwably engages with the corresponding lead screw (752a, 752b). In the example shown, each gear (755a, 755b) includes external teeth (756a, 756b) for facilitating the driving of the corresponding motors (743a, 743b) on the corresponding linear actuators (742a, 742b).

[0143] For this purpose, the first motor and the second motor (743a, 743b) of this embodiment are respectively mounted to the first drive support frame and the second drive support frame (747a, 747b), and include a first output shaft and a second output shaft (not shown) respectively carrying the first pinion and the second pinion (757a, 757b). In the illustrated embodiment, each pinion (757a, 757b) includes external teeth (758a, 758b) that mesh with the external teeth (756a, 756b) of the corresponding gear (755a, 755b), such that each gear (755a, 755b) is configured to rotate about the corresponding longitudinal axis (LA1, LA2) in response to the rotation of the output shaft of the corresponding motor (743a, 743b). Although the pinions (757a, 757b) are adjacent to each other in the illustrated embodiment, it should be understood that the external teeth (758a, 758b) do not mesh with each other. Therefore, each motor (743a, 743b) is configured to independently drive the corresponding lead screw (752a, 752b) together with the corresponding plunger cap (754a, 754b) to translate along the corresponding longitudinal axis (LA1, LA2).

[0144] As shown in Figure 30, the first and second drive components (713a, 713b) of this example also include corresponding home position switches (759), which are mounted to the lower surface of the corresponding drive support plates (746a, 746b) via corresponding fasteners in the form of screws (745). Each home position switch (759) can be configured to be triggered by the corresponding lead screw (752a, 752b) when the corresponding lead screw (752a, 752b) is in a predetermined home position (such as the nearest side position) along the corresponding longitudinal axis (LA1, LA2); and to generate a signal in response to the corresponding lead screw (752a, 752b) being in the predetermined home position. Each home position switch (759) can be operatively communicated with an off-board processor (707) via a circuit board assembly (711), such that each home position switch (759) can be facilitated by the off-board processor (707) monitoring the position of the corresponding lead screw (752a, 752b) along the corresponding longitudinal axis (LA1, LA2). For example, the off-board processor (707) can be configured to determine whether each lead screw (752a, 752b) is in a predetermined home position along the corresponding longitudinal axis (LA1, LA2) based on one or more signals received by the off-board processor (707) from the corresponding home position switch (759). In some versions, the first drive assembly and the second drive assembly (713a, 713b) may respectively include corresponding linear sensors (not shown) as a supplement to or replacement of the corresponding home position switch (759). For example, such linear sensors can be similar to any of the linear sensors (176, 656) described above, and can be configured to generate varying data values ​​based on the longitudinal position of the corresponding lead screws (752a, 752b) along the corresponding longitudinal axes (LA1, LA2).

[0145] In some versions, the first and second drive assemblies (713a, 713b) may respectively include corresponding strain gauges (not shown) configured to detect strain present in the corresponding drive assembly (713a, 713b). For example, these strain gauges may be respectively mounted to the upper surface of the corresponding drive support plate (746a, 746b) or at any other suitable location on the corresponding frame (744a, 744b). These strain gauges may respectively be operatively communicated with an off-board processor (707) via a circuit board assembly (711), such that each strain gauge can be facilitated by the off-board processor (707) to monitor strain present in the corresponding drive assembly (713a, 713b).

[0146] Although the drive assembly (713a, 713b) of this example includes a linear actuator (742a, 742b) defined by a lead screw (752a, 752b) and a corresponding lead nut (defined by a gear (755a, 755b)), it should be understood that any other suitable type of actuator, such as any other suitable type of linear actuator, may be provided in place of one or both of the linear actuators (742a, 742b).

[0147] Referring now primarily to Figures 28 and 31, the circuit board assembly (711) of this example includes a substrate (760) that is fixedly fastened to the upper surface of the bottom wall (735) of the housing (710). In the example shown, the circuit board assembly (711) further includes: a near-side wired protocol control interface in the form of a Universal Serial Bus (USB) port (761), accessible via a near-side recess (739) of the lower housing (715) and configured to be coupled to a wire (708) for positioning the circuit board assembly (711) in operative communication with an off-board processor (707); and a far-side wired protocol control interface in the form of a USB port (762), accessible via a far-side recess (741) of the lower housing (715) and configured to be coupled to a wire (175) for positioning the circuit board assembly (711) in operative communication with circuit board assemblies (170, 650) of instruments (100, 400). In some cases, the off-board processor (707) may be configured to supply power to the circuit board assembly (711) of the fluid control unit (700) via a near-side USB port (761) (e.g., as a supplement or alternative to the power supplied to the circuit board assembly (711) by the battery (712); and / or the circuit board assembly (711) of the fluid control unit (700) may be configured to supply power to the circuit board assembly (170, 650) of the device (100, 400) via a far-side USB port (762).

[0148] The board assembly (711) further includes a wireless protocol control interface in the form of a Bluetooth Low Energy (BLE) module (763) for positioning the board assembly (711) to operatively communicate with the off-board processor (707). Therefore, the board assembly (711) can be positioned to operatively communicate with the off-board processor (707) via a USB port (761) and / or via the BLE module (763). In some versions, either the near-side USB port (761) or the BLE module (763) can be omitted. For example, the near-side USB port (761) can be omitted. In these cases, the board assembly (711) can still be positioned to operatively communicate with the off-board processor (707), such as via the BLE module (763). In the example shown, the circuit board assembly (711) further includes an array of spring-loaded pins (also referred to as spring pins) (764) that extend through an array of holes (728) in the upper housing (714) and are configured to engage corresponding portions of the housing (704) to position the circuit board assembly (711) in operative communication with the housing (704).

[0149] The circuit board assembly (711) of this example further includes a power switch (also referred to as an on / off switch) (765), which is accessible via a proximal recess (740) of the lower housing (715) and configured to selectively allow power to be supplied from the battery (712) to the circuit board assembly (711) and / or the motors (743a, 743b). In the illustrated example, the circuit board assembly (711) further includes a non-volatile memory storage device in the form of a secure digital storage (SD) card (766). The SD card (766) may be configured to store event log data and / or instructions for a non-airborne processor (707). For example, the non-airborne processor (707) may be configured to perform any or more of the functions described herein based on the instructions stored by the SD card (766).

[0150] The circuit board assembly (711) of this example further includes a user input element in the form of a tactile switch (767) positioned relative to a start button (733) such that an operator can actuate the tactile switch (767) by pressing the start button (733). The tactile switch (767) can be operatively communicated with an off-board processor (707) via a USB port (761) and / or via a BLE module (763); and the off-board processor (707) can then be operatively communicated with one or two motors (743a, 743b) via the USB port (761) and / or via the BLE module (763), and can be configured to activate one or two motors (743a, 743b) in response to actuation of the tactile switch (767), as described in more detail below.

[0151] In the illustrated example, the circuit board assembly (711) further includes at least one user feedback element in the form of a light-emitting element, such as one or more red-green-blue (RGB) programmable LEDs (768) (one shown). The LED (768) can be configured to emit light selectively and is positioned relative to a light guide (734) such that the light guide (734) can transmit the light emitted by the LED (768) through the top wall (716) of the housing (710). The LED (768) can be operatively communicated with an off-board processor (707) via a USB port (761) and / or via a BLE module (763); and the off-board processor (707) can be configured to cause the LED (768) to emit light differently based on specific states of the system defined by the instruments (100, 400) and the fluid control unit (700), as described in more detail below. Although not shown, the circuit board assembly (711) may include additional LEDs positioned relative to (e.g., below) elongated slots (726a, 726b) of the housing (710) such that the elongated slots (726a, 726b) can transmit light emitted by these additional LEDs through the expansion dock (724) of the housing (710).

[0152] The circuit board assembly (711) of this example further includes at least one user feedback element in the form of a speaker (769), which is configured to provide one or more audible sounds. The speaker (769) can operatively communicate with the off-board processor (707) via a USB port (761) and / or via a BLE module (763); and the off-board processor (707) can be configured to provide different audible sounds via the speaker (769) based on specific states of the system defined by the instruments (100, 400) and the fluid control unit (700), as described in more detail below.

[0153] While the various components of the circuit board assembly (711) have been described as operatively communicating with the off-board processor (707), these components may additionally or alternatively communicate operatively with an on-board processor of the fluid control unit (700), such as a microprocessor (not shown) disposed on the substrate (760) or otherwise incorporated into the circuit board assembly (711). Such an on-board processor may be configured to perform any or more of the functions described herein in connection with the off-board processor (707).

[0154] As shown in Figures 24-25 and 32-35, the box (704) of this example includes a housing (770) and various components contained within the housing (770), including a first syringe connector and a second syringe connector (771a, 771b) for facilitating connection between the box (704) and a first syringe and a second syringe (706a, 706b), respectively. In the illustrated example, the housing (771) is defined by an upper housing and a lower housing (772, 773).

[0155] Referring primarily to Figures 25 and 32 to 35, the lower housing (773) of the outer casing (770) includes a bottom wall (774) configured to support syringe connectors (771a, 771b), and further includes a proximal sidewall (775), a distal sidewall (776), and a first sidewall and a second sidewall (777a, 777b), each extending generally upward from the bottom wall (774). In this example, the lower housing (773) further includes a first generally U-shaped syringe receiving portion and a second generally U-shaped syringe receiving portion (778a, 778b) extending downward from the upper surface of the bottom wall (774). The first syringe receiving portion and the second syringe receiving portion (778a, 778b) are sized and configured to at least partially receive the first syringe and the second syringe (706a, 706b) respectively when the syringes (706a, 706b) are connected to the housing (704). In the example shown, the first syringe receiving portion and the second syringe receiving portion (778a, 778b) also accommodate corresponding portions of the syringe connector (771a, 771b).

[0156] The lower housing (773) of this example further includes a channel (779) extending upward from the lower surface of the bottom wall (774) and configured to receive an elevated central platform (727) of the expansion dock (724) of the control module (702). The lower housing (773) further includes a first guide member and a second guide member in the form of tracks (780a, 780b), which extend laterally inward below the respective sides of the channel (779) to define a first recess and a second recess (781a, 781b). The tracks (780a, 780b) are configured to be slidably received in the recesses (730a, 730b) of the expansion dock (724) of the control module (702), and the recesses (781a, 781b) are configured to slidably receive the tracks (729a, 729b) of the expansion dock (724) of the control module (702), respectively, to facilitate proper alignment of the box (704) and the control module (702) during connection. For example, the tracks (780a, 780b) and grooves (781a, 781b) of the box (704) can interact with the corresponding grooves (730a, 730b) and tracks (729a, 729b) of the control module (702) to substantially align the syringes (706a, 706b) along the corresponding longitudinal axes (LA1, LA2).

[0157] In the illustrated example, the first and second recesses (781a, 781b) terminate distally at the first and second stops (782a, 782b) of the lower housing (773), respectively, such that the stops (782a, 782b) can restrict the advance of the tracks (729a, 729b) along the recesses (781a, 781b). An array of holes (783) extends through the bottom wall (774) to the channel (779) to hold an array of electrical contacts (784). The holes (783) and contacts (784) are arranged to align with corresponding holes (728) and spring-loaded pins (764) of the control module (702), such that each spring-loaded pin (764) can engage a corresponding contact (784) to position the circuit board assembly (711) in operative communication with the housing (704).

[0158] The first and second elongated slots (785a, 785b) extend through the bottom wall (774) on the respective sides of the channel (779) and are arranged to align with the first and second elongated slots (726a, 726b) of the control module (702) to transmit light from the LED of the circuit board assembly (711) to the syringes (706a, 706b) received in the respective syringe receivers (778a, 778b), thereby enhancing the visibility of the syringes (706a, 706b) to the operator.

[0159] The lower housing (773) of this example further includes a first side recess and a second side recess (786a, 786b) extending downward from the upper surfaces of the first side wall and the second side wall (777a, 777b), respectively, and a first proximal side recess and a second proximal side recess (787a, 787b) extending downward from the upper surface of the proximal side wall (775), for accommodating a first connecting member and a second connecting member in the form of a spring-loaded latch (788a, 788b). In this respect, the latches (788a, 788b) respectively include: corresponding locking arms (789a, 789b) extending through corresponding proximal recesses (787a, 787b) for engaging the periphery of corresponding openings (723a, 723b) of the control module (702) to removably connect the box (704) to the control module (702); and corresponding release buttons (790a, 790b) accessible via corresponding side recesses (786a, 786b) for disengaging the corresponding locking arms (789a, 789b) from the periphery of the corresponding openings (723a, 723b) to remove the box (704) from the control module (702).

[0160] In the illustrated example, the upper housing (772) of the outer casing (770) includes a top wall (791) and further includes a proximal sidewall (792), a distal sidewall (793), and a first sidewall and a second sidewall (794a, 794b), each extending generally downward from the top wall (791). The upper housing (772) of this example further includes a first opening and a second opening (795a, 795b), both extending downward through the top wall (791) and distally from the proximal sidewall (792), for at least partially receiving a first syringe and a second syringe (706a, 706b), respectively.

[0161] The first and second syringe connectors (771a, 771b) of this example include: a first proximal fluid connector and a second proximal fluid connector in the form of female Luer connectors (796a, 796b), configured to connect to the distal ends of the first syringe and the second syringe (706a, 706b), respectively; and a first distal fluid connector and a second distal fluid connector in the form of male Luer connectors (797a, 797b), configured to connect to the proximal ends of fluid conduits (142, 144), respectively. In some versions, the first female Luer connector (796a) may not be able to connect to the distal end of the second syringe (706b), and the second female Luer connector (796b) may not be able to connect to the distal end of the first syringe (706a), such that the first syringe (706a) can only connect to the first female Luer connector (796a), and the second syringe (706b) can only connect to the second female Luer connector (796b), to prevent accidental dispensing of the foam fluid (340) by the second drive assembly (713b) and / or accidental dispensing of the therapeutic agent (341) by the first drive assembly (713a). In the illustrated example, the syringe connectors (771a, 771b) include corresponding dead volume reduction inserts (798a, 798b) disposed within the corresponding male Luer connectors (797a, 797b).

[0162] The first and second syringe connectors (771a, 771b) of this example also include a first pressure transducer and a second pressure transducer (799a, 799b), respectively, configured to detect the amount of fluid pressure present in the respective syringe connectors (771a, 771b). Each pressure transducer (799a, 799b) is operatively communicable with a circuit board assembly (711) via a corresponding contact (784) and a spring-loaded pin (764), and is further operatively communicable with a non-airborne processor (707) via the circuit board assembly (711), such that each pressure transducer (799a, 799b) can facilitate monitoring of the amount of fluid pressure present in the respective syringe connectors (771a, 771b) by the non-airborne processor (707).

[0163] In examples of the method of use, the syringes (706a, 706b) may initially be equipped with: a corresponding needle (not shown) connected to the distal end of the respective syringe (706a, 706b); and a corresponding plunger rod (not shown) screwably connected to a stopper (also called a piston) housed within the respective syringe (706a, 706b). In some versions, the stopper may each include a tapered distal tip. The syringes (706a, 706b) may be filled with the desired volume of bubbly fluid (340) and therapeutic agent (341) respectively by inserting the corresponding needle into the appropriate vial of bubbly fluid (340) or therapeutic agent (341), and by withdrawing the corresponding plunger rod proximally to draw the desired volume of fluid (340, 341) from the vial into the respective syringe (706a, 706b). The corresponding needles can then be detached from the distal ends of the corresponding filled syringes (706a, 706b), and the corresponding plunger rods can also be detached from the plugs housed within the corresponding filled syringes (706a, 706b). The filled syringes (706a, 706b) can then be connected to the housing (704) by screwing the distal ends of each syringe (706a, 706b) onto the corresponding female Luer connectors (796a, 796b).

[0164] The box (704) can then be attached to the control module (702) by sliding the tracks (780a, 780b) and grooves (781a, 781b) of the box (704) along the corresponding grooves (730a, 730b) and tracks (729a, 729b) of the control module (702) until the spring-loaded latches (788a, 788b) of the box (704) engage the corresponding openings (723a, 723b) of the control module (702) to removably connect the box (704) to the control module (702). In some versions, the engagement of the spring-loaded latches (788a, 788b) of the housing (704) with the corresponding ports (723a, 723b) of the control module (702) can provide audible feedback (e.g., a "click") to the operator, indicating that the housing (704) is connected to the control module (702). With the fluid control unit (700) in a loaded state, the fluid control unit (700) can be operatively connected to the instruments (100, 400) via the corresponding tubing assemblies (140, 440). For example, a wire (175) can be plugged into a remote USB port (762) to thereby position the circuit board assembly (711) of the fluid control unit (700) in operative communication with the circuit board assembly (170, 650) of the instruments (100, 400); and the proximal end of the fluid conduit (142, 144) can be screwed into a corresponding male Luer connector (797a, 797b).

[0165] With the fluid control unit (700) loaded and operatively connected to the instruments (100, 400), the operator can connect power to the fluid control unit (700) by switching the power switch (765) to the "ON" state. In some versions, an onboard processor (not shown) can be configured to send signals to an LED (768) to: illuminate in a uniquely visible manner (e.g., pure white) to indicate power on; illuminate in another uniquely visible manner (e.g., flashing red) to indicate low battery (712); and / or illuminate in yet another uniquely visible manner (e.g., pure red) to indicate a connection error between the fluid control unit (700) and the instruments (100, 400). In some other versions, these signals can be sent by a non-onboard processor (707) (e.g., after the fluid control unit (700) has been operatively connected to a non-onboard processor (707)). Alternatively, an additional LED below the elongated slots (726a, 726b) of the control module (702) can emit light through the elongated slots (726a, 726b) and through the corresponding elongated slots (785a, 785b) of the housing (704) when the fluid control unit (700) is powered on, thereby providing backlighting for the syringes (706a, 706b), which can assist the operator in visually observing the water level (340, 341) of the fluid in the syringes (706a, 706b).

[0166] With the fluid control unit (700) loaded, coupled to the instruments (100, 400), and powered on, the fluid control unit (700) can be operatively coupled to an off-board processor (707). For example, a wire (708) can be plugged into a proximal USB port (761) to thereby position the circuit board assembly (711) of the fluid control unit (700) in operative communication with the off-board processor (707). Alternatively or alternatively, the circuit board assembly (711) can be positioned to operatively communicate with the off-board processor (707) via a BLE module (763). In some versions, the off-board processor (707) can also be operatively coupled to one or more of a display, microscope, and / or video overlay system. For example, the off-board processor (707) can be configured to present various text or graphic messages via a display, and these messages can be overlaid on a real-time image of the patient's eye (301) captured by a microscope.

[0167] To activate the system, the operator can press the start button (733) to actuate the tactile switch (767). An off-board processor (707) can be configured to signal motors (743a, 743b) in response to actuation of the tactile switch (767) to initiate the system for a predetermined duration sufficient to initiate the system (e.g., initiation of a delivery line for the foam fluid (340) and / or the therapeutic agent (341)). In some versions, the off-board processor (707) can also be configured to signal LEDs (658) of the device (100, 400) to emit light in a uniquely visible manner (e.g., pure green) to indicate that the system is being initiated (e.g., initiation of a delivery line for the foam fluid (340) and / or the therapeutic agent (341)). The operator can release the start button (733) in response to observing the green light emitted by the LED (658) and / or in response to hearing the motor (743a, 743b) start.

[0168] Upon startup, each motor (743a, 743b) drives its corresponding lead screw (752a, 752b) to translate distally along its corresponding longitudinal axis (LA1, LA2), causing the corresponding plunger cap (754a, 754b) to engage a stopper housed within its corresponding syringe (706a, 706b) and push the stopper distally. The stopper can then be driven from its corresponding syringe (706a, 706b) via its corresponding syringe connector (771a, 771b) to a portion of the fluid (340, 341) and into its corresponding fluid conduit (142, 144). This, in turn, allows for system startup by clearing any air from the fluid path between one or both syringes (706a, 706b) and the distal end of the needle (150). In some cases, the motors (743a, 743b) may be started sequentially. In other cases, both motors (743a, 743b) may be started substantially simultaneously. It should also be understood that, in some cases, an air gap may be provided between the guide bubble (340) and the therapeutic fluid (341) to prevent the therapeutic fluid (341) from mixing with the guide bubble (340). Given the teachings herein, various suitable methods of system startup using the guide bubble (340) fluid, the therapeutic fluid (341), and / or an intentional air gap will be apparent to those skilled in the art. An off-board processor (707) may be configured to continuously monitor the startup status of the system during the startup process (e.g., based on the duration for which each motor (743a, 743b) is started). The off-board processor (707) may be configured to present text or graphical messages (e.g., via a display) to indicate the current startup status. The off-board processor (707) may be configured to deactivate the motors (743a, 743b) in response to determining that the system has been successfully started, and / or to send a signal to a speaker (769) to provide a unique series of audible or pure tones to indicate that the system has been started.

[0169] In some versions, the off-board processor (707) can be configured to automatically perform a predetermined sequence of steps to activate the system in response to actuation of the tactile switch (767). For example, the off-board processor (707) may initially respond to actuation of the tactile switch (767) by activating a first motor (743a) to drive a first lead screw (752a) distally along a first longitudinal axis (LA1) until a first plunger cap (754a) engages a plug contained within a first syringe (706a). The off-board processor (707) may then activate a second motor (743b) to drive a second lead screw (752b) distally along a second longitudinal axis (LA2) until a second plunger cap (754b) engages a plug contained within a second syringe (706b). Next, the off-board processor (707) can restart the first motor (743a) to drive the first lead screw (752a), together with the first plunger cap (754a) and the plug housed in the first syringe (706a), to translate distally along the first longitudinal axis (LA1) to at least partially (e.g., about halfway) activate the fluid path between the first syringe (706a) and the distal end of the needle (150). The off-board processor (707) can then restart the second motor (743b) to drive the second lead screw (752b), together with the second plunger cap (754b) and the plug housed in the second syringe (706b), to translate distally along the second longitudinal axis (LA2) to at least partially activate the fluid path between the second syringe (706b) and the distal end of the needle (150). Then, the off-board processor (707) can restart the first motor (743a) to drive the first lead screw (752a), together with the first plunger cap (754a) and the plug housed in the first syringe (706a), to translate distally along the first longitudinal axis (LA1) to a point sufficient to complete the fluid path between the distal end of the first syringe (706a) and the needle (150). This predetermined sequence of steps can prevent fluid (340, 341) from flowing back from each syringe (706a, 706b) into the other syringe (706b, 706a).

[0170] Once the system is activated, the operator can advance the needle (150) distally relative to the cannula (130, 430) of the instrument (100, 400) to protrude from the corresponding opening (134) of the cannula (130, 430). For example, after the cannula (130, 430) has advanced to the delivery site as shown in Figure 13D, the operator can advance the needle (150) of the instrument (100, 400) by rotating the corresponding knob / knob assembly (120, 420), so that the needle (150) pierces the choroid (306) without penetrating the retina (308), as shown in Figure 13E. The off-board processor (707) can be configured to present text or graphic messages indicating the longitudinal position of the needle (150) based on one or more signals received by the off-board processor (707) from corresponding rotational or linear sensors (176, 656) of the instrument (100, 400). In some versions, the off-board processor (707) can be configured to activate a first motor (743a) in response to distal movement of the needle (150) sensed by the sensors (176, 656) to drive a first lead screw (752a) to translate distally along a first longitudinal axis (LA1) together with a first plunger cap (754a) and a plug housed within a first syringe (706a). The off-board processor (707) can thereby provide bubble fluid (340) via the needle (150) at a predetermined fixed flow rate as described above during distal advance of the needle (150) to facilitate the safe penetration of the distal tip (152) of the needle (150) into the choroid (306) without penetrating the retina (308). Alternatively or additionally, the off-board processor (707) can be configured to signal the LED (658) of the instrument (100, 400) to emit light in a uniquely visible manner (e.g., pure blue) to indicate that the needle (150) has advanced distally to its most distal position of full extension, so that the needle (150) is correctly positioned to deliver the therapeutic agent (341).

[0171] With the needle (150) correctly positioned to deliver the therapeutic agent (341), the operator can first deliver the vesicular fluid (340) via the needle (150) to form a vesicular fluid (340) bag, as shown in Figure 13F. For example, after the needle (150) has pierced the choroid (306) without penetrating the retina (308), the operator can press the lower rocker / first button (112, 412) of the device (100, 400) to activate the corresponding tactile switch (652). The off-board processor (707) can be configured to send a signal to a first motor (743a) in response to actuation of a tactile switch (652) to activate it, thereby driving a first lead screw (752a) to translate distally along a first longitudinal axis (LA1) together with a first plunger cap (754a) and a stopper housed within a first syringe (706a), thereby dispensing bubble fluid (340) at a predetermined fixed flow rate when the tactile switch (652) is actuated (e.g., when the first button (412) is pressed). The off-board processor (707) can be configured to continuously monitor the volume of bubble fluid (340) delivered via the needle (150), such as based on the fixed flow rate and the duration of bubble fluid (340) dispensing. A non-airborne processor (707) can be configured (e.g., via a display) to present text or graphic messages indicating the volume of bubble fluid (340) delivered via needle (150). In this example, the flow rate of the bubble fluid (340) is predetermined. By way of example only, the predetermined flow rate of the bubble fluid (340) can range from approximately 100 µL per minute to approximately 400 µL per minute. For example, the predetermined flow rate of the bubble fluid (340) can be approximately 200 µL per minute. In some other versions, the fluid control unit (700) and / or the host computer provides user input, whereby the operator can select to assign a desired flow rate of the bubble fluid (340) when the first tactile switch (652) is actuated. Additionally or alternatively, the flow rate of the bubble fluid (340) can vary during delivery, such as based on a predetermined flow rate sequence selected by the operator. When the desired volume of bubble fluid (340) has been delivered, the operator can release the lower rocker / first button (112, 412); and the off-board processor (707) can be configured to deactivate the first motor (743a) in response to the release of the corresponding tactile switch (652).

[0172] In some versions, the off-board processor (707) can be configured to determine, in response to actuation of the tactile switch (652), whether the needle (150) is in its fully retracted proximal position before sending a signal to the first motor (743a) for activation, and can be configured to send a signal to the first motor (743a) for activation only when the needle (150) is not in its fully retracted proximal position. In other words, the off-board processor (707) can be configured to avoid sending a signal to the first motor (743a) for activation when the needle (150) is in its fully retracted proximal position to prevent accidental delivery of the bubble fluid (340) before the needle (150) advances distally.

[0173] After the desired volume of foam fluid (340) has been delivered, the operator can deliver the therapeutic agent (341) via the needle (150). For example, after a bag of foam fluid (340) has been formed as shown in FIG13F, the operator can press the upper rocker / second button (114, 414) of the instrument (100, 400) to actuate the corresponding tactile switch (654). The off-board processor (707) can be configured to send a signal to the second motor (743b) to activate in response to actuation of the tactile switch (654), so as to drive the second lead screw (752b) together with the second plunger cap (754b) and the plug housed in the second syringe (706b) to translate distally along the second longitudinal axis (LA2), thereby dispensing the therapeutic agent (341) at a precise fixed flow rate when the second tactile switch (654) is actuated (e.g., when the second button (414) is pressed). The off-board processor (707) can be configured to continuously monitor the volume of the therapeutic agent (341) delivered via the needle (150), such as based on a fixed flow rate and the duration for which the therapeutic agent (341) is dispensed. For example, the off-board processor (707) can be configured to monitor the cumulative volume of the therapeutic agent (341) delivered to the eye (301) via multiple discrete deliveries via the needle (150), such as when the second button (414) is pressed, released, and then pressed again. The off-board processor (707) can be configured (e.g., via a display) to present text or graphic messages indicating the volume of the therapeutic agent (341) delivered via the needle (150). In some versions, the fluid control unit (700) and / or the host computer provide user input, whereby the operator can select a desired flow rate of the therapeutic agent (341) when the second tactile switch (654) is actuated. By way of example only, the selected flow rate of the therapeutic agent (341) can be in the range of approximately 100 µL / min to approximately 400 µL / min. Alternatively or additionally, the flow rate of the therapeutic agent (341) can be varied during delivery, such as based on a predetermined flow rate sequence selected by the operator. Once the desired volume of the therapeutic agent (341) has been delivered, the operator can release the upper rocker / second button (114, 414); and the off-board processor (707) can be configured to deactivate the second motor (743b) in response to the release of the corresponding tactile switch (654).

[0174] In some versions, the off-board processor (707) can be configured to send a signal to the second motor (743b) in response to actuation of the haptic switch (654) to initiate delivery for a predetermined duration sufficient to deliver a predetermined volume of therapeutic agent (341). For example, the host computer may provide user input whereby the operator can select the desired volume of therapeutic agent (341) to be dispensed, such as in the range of approximately 25 µL to approximately 300 µL; and the off-board processor (707) can be configured to deactivate the second motor (743b) in response to determining that the desired volume of therapeutic agent (341) has been successfully dispensed. In other words, once the desired volume of therapeutic agent (341) input to the host computer has been administered, the fluid control unit (700) can automatically stop delivering the therapeutic agent (341). In some cases, the off-board processor (707) can be configured to sequentially activate and deactivate the second motor (743b) to incrementally deliver the desired volume of therapeutic agent (341). For example, an off-board processor (707) can be configured to deliver a desired volume of therapeutic agent (341) in increments of about 2 µL.

[0175] In some versions, the off-board processor (707) can be configured to determine, in response to actuation of the tactile switch (654), whether the needle (150) is in its fully retracted proximal position before sending a signal to the second motor (743b) for activation, and can be configured to send a signal to the second motor (743b) for activation only when the needle (150) is not in its fully retracted proximal position. In other words, the off-board processor (707) can be configured to avoid sending a signal to the second motor (743b) for activation when the needle (150) is in its fully retracted proximal position to prevent accidental delivery of the therapeutic agent (341) before the needle (150) advances distally.

[0176] The off-board processor (707) can be configured to continuously monitor the amount of fluid pressure present in the syringe connectors (771a, 771b), such as based on signals received by the off-board processor (707) from pressure converters (799a, 799b). In some versions, the off-board processor (707) can compare the amount of fluid pressure present in each syringe connector (771a, 771b) with a threshold and can determine an error state of the system in response to a monitored fluid pressure exceeding the threshold. For example, the off-board processor (707) can determine that there is an obstruction (e.g., blockage) in the fluid path between one of the syringes (706a, 706b) and the distal end of the needle (150) in response to a monitored fluid pressure exceeding the threshold in the corresponding syringe connector (771a, 771b). The off-board processor (707) may be configured to: (e.g., via a display) present a text or graphic message to indicate a system error state; send a signal to any of the LEDs (658, 768) to emit light in a uniquely visible manner (e.g., flashing or solid color) to indicate a system error state; and / or send a signal to any of the speakers (660, 769) to provide a unique audible tone or pure tone series to indicate a system error state. Alternatively or additionally, the off-board processor (707) may be configured to terminate and / or prevent the delivery of any fluid (340, 341) when the system is in such an error state (e.g., by disabling one or two motors (743a, 743b) until the system is no longer in such an error state).

[0177] Alternatively, the off-board processor (707) can be configured to continuously monitor strain present in the drive components (713a, 713b), such as based on signals received by the off-board processor (707) from strain gauges in the drive components (713a, 713b). In some versions, the off-board processor (707) can compare the strain present in each drive component (713a, 713b) to a threshold and can determine an error state of the system in response to a monitored strain exceeding the threshold. For example, the off-board processor (707) can determine the presence of an obstruction (e.g., blockage) in the fluid path between one of the syringes (706a, 706b) and the distal end of the needle (150) in response to a monitored strain present in the corresponding drive component (713a, 713b) exceeding the threshold. The off-board processor (707) may be configured to: (e.g., via a display) present a text or graphic message to indicate a system error state; send a signal to any of the LEDs (658, 768) to emit light in a uniquely visible manner (e.g., flashing or solid color) to indicate a system error state; and / or send a signal to any of the speakers (660, 769) to provide a unique audible tone or pure tone series to indicate a system error state. Alternatively or additionally, the off-board processor (707) may be configured to terminate and / or prevent the delivery of any fluid (340, 341) when the system is in such an error state (e.g., by disabling one or two motors (743a, 743b) until the system is no longer in such an error state).

[0178] In some cases where the off-board processor (707) uses data from these strain gauges to detect obstructions in the fluid path, the pressure transducer (799a, 799b) and the corresponding contact (784) and spring-loaded pin (764) can be omitted. Alternatively, the off-board processor (707) can be configured to determine the fill level of each fluid (340, 341) in the corresponding syringes (706a, 706b) based at least in part on the strain present in the corresponding drive components (713a, 713b), and can be configured to (e.g., via a display) present text or graphic messages to indicate the fill level of each fluid (340, 341) in the corresponding syringes (706a, 706b).

[0179] Although the LEDs (658, 768) and speakers (660, 769) of the instrument (400) and fluid control unit (700) have been described as being used by the off-board processor (707) in various ways, other suitable ways of using the LEDs (658, 768) and speakers (660, 769) will be apparent to those skilled in the art in light of the teachings herein. For example, the off-board processor (707) may utilize the LEDs (658) and speakers (660) of the instrument (400) in any of the ways described herein in connection with the LEDs (768) and speakers (769) of the fluid control unit (700), and / or may utilize the LEDs (768) and speakers (769) of the fluid control unit (700) in any of the ways described herein in connection with the LEDs (658) and speakers (660) of the instrument (400). In some cases, the off-board processor (707) may utilize external speakers, such as built-in speakers of the display (not shown), in any of the ways described herein in connection with one or two speakers (660, 769), such that one or two speakers (660, 769) may be omitted.

[0180] V. Combined Examples

[0181] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claim that may be set forth in this application or at any time in a subsequent filing of this application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that certain features mentioned in the following examples may be omitted in some variations. Therefore, no aspect or feature mentioned below should be considered critical unless the inventor or successor to the inventor expressly indicates otherwise at a later date. If any claim set forth in this application or a subsequent application related to this application includes additional features beyond those mentioned below, it should not be presumed that such additional features were added for any reason related to patentability.

[0182] Example 1

[0183] A device comprising: (a) an instrument body; (b) a cannula extending distally from the instrument body, wherein the cannula is flexible, wherein the cannula is sized and configured to advance between the sclera and choroid of a patient's eye; (c) a needle slidably disposed within the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position; (d) a rotary knob configured to rotate relative to the instrument body about a rotation axis and thereby drive the needle to translate between the proximal and distal positions; and (e) At least one deflectable member is fixed to prevent rotation relative to either the instrument body or the rotary knob, wherein the at least one deflectable member is configured to frictionally engage either the instrument body or the rotary knob to prevent the rotary knob from rotating about the rotation axis without a predetermined threshold rotational force being applied to the rotary knob.

[0184] Example 2

[0185] According to the device of Example 1, wherein the at least one deflectable member is fixed to prevent rotation relative to the rotary knob, wherein the at least one deflectable member is configured to frictionally engage the device body to prevent the rotary knob from rotating about the rotation axis without the predetermined threshold rotational force being applied to the rotary knob.

[0186] Example 3

[0187] According to the device of Example 2, the at least one deflectable member is configured to deflect radially inward relative to the axis of rotation from a non-deflected state to a deflected state, wherein the at least one deflectable member is elastically biased toward the non-deflected state.

[0188] Example 4

[0189] According to any one of Examples 2 to 3, the device body is configured to push the at least one deflectable member toward the deflection state.

[0190] Example 5

[0191] The device according to any one of Examples 2 to 4, wherein the instrument includes a protrusion, wherein the protrusion is configured to push the at least one deflectable member toward the deflected state.

[0192] Example 6

[0193] The device according to any one of Examples 1 to 5, wherein the at least one deflectable member comprises a plurality of deflectable members.

[0194] Example 7

[0195] According to the device of Example 6, the plurality of deflectable members are circumferentially spaced apart from each other at equal intervals.

[0196] Example 8

[0197] The device according to any one of Examples 6 to 7, wherein the plurality of deflectable members comprises three deflectable members.

[0198] Example 9

[0199] The device according to any one of Examples 1 to 8, wherein the at least one deflectable member comprises at least one deflectable beam.

[0200] Example 10

[0201] According to the device of Example 9, the at least one deflectable beam is defined by at least a pair of recesses.

[0202] Example 11

[0203] According to any one of Examples 9 to 10, the at least one deflectable beam includes at least one stop extending radially outward from the radially outer surface of the at least one deflectable beam, wherein the at least one stop is configured to frictionally engage the device body.

[0204] Example 12

[0205] The device according to any one of Examples 1 to 11 further includes a torque ring, wherein the torque ring includes the at least one deflectable member.

[0206] Example 13

[0207] According to the device of Example 12, the rotary knob includes a first interlocking member, and the torque ring includes a second interlocking member configured to interlock with the first interlocking member to fix the torque ring to prevent rotation relative to the rotary knob.

[0208] Example 14

[0209] According to the device of Example 13, one of the first interlocking member or the second interlocking member includes a post, and the other of the first interlocking member or the second interlocking member includes a recess configured to receive the post and thereby interlock with the post.

[0210] Example 15

[0211] According to any one of Examples 12 to 14, the rotary knob defines an interior, wherein the torque ring is at least partially disposed within the interior of the rotary knob.

[0212] Example 16

[0213] An apparatus comprising: (a) an instrument body; (b) a cannula extending distally from the instrument body, wherein the cannula is flexible, wherein the cannula is sized and configured to advance between the sclera and choroid of a patient's eye; (c) a needle slidably disposed within the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position; (d) a rotary knob configured to drive the needle to translate between the proximal and distal positions; and (e) a torque ring configured to resist rotation of the rotary knob.

[0214] Example 17

[0215] According to the device of Example 16, the torque ring is fixed to prevent rotation relative to either the instrument body or the rotary knob.

[0216] Example 18

[0217] According to the device of Example 17, the torque ring is integrally formed as a single piece together with either the instrument body or the rotary knob.

[0218] Example 19

[0219] According to any one of Examples 17 to 18, the torque ring is fixed to prevent rotation relative to the rotary knob.

[0220] Example 20

[0221] According to any one of Examples 16 to 19, the torque ring includes at least one deflectable member configured to provide friction between the rotary knob and the instrument body.

[0222] Example 21

[0223] A device comprising: (a) an instrument body; (b) a cannula extending distally from the instrument body, wherein the cannula is flexible, wherein the cannula is sized and configured to advance between the sclera and choroid of a patient's eye; (c) a needle slidably disposed within the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned internally within the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned externally within the cannula when the needle is in the distal position; (d) a knob configured to rotate relative to the instrument body and thereby drive the needle to translate between the proximal and distal positions; (e) at least one deflectable member configured to frictionally engage one of the instrument body or the knob to prevent rotation of the knob without a predetermined threshold rotational force being applied to the knob; and (f) A fluid control unit configured to supply at least one fluid to the needle.

[0224] Example 22

[0225] The device according to Example 21 further includes a sensor positioned on or within the device body, wherein the sensor is operatively in communication with the fluid control unit, and wherein the sensor is operable to detect the position of the needle relative to the cannula.

[0226] Example 23

[0227] According to the device of Example 22, the fluid control unit is configured to supply the at least one fluid to the needle in response to a signal received from the sensor.

[0228] Example 24

[0229] The device according to any one of Examples 21 to 23 further includes at least one user input element located on or within the instrument body, wherein the at least one user input element is operatively in communication with the fluid control unit, wherein the fluid control unit is configured to supply the at least one fluid to the needle in response to at least one signal received from the at least one user input element.

[0230] Example 25

[0231] According to the device of Example 24, wherein the at least one user input element includes a first user input element, wherein the fluid control unit is configured to supply a first fluid to the needle in response to a first signal received from the first user input element.

[0232] Example 26

[0233] According to the device of Example 25, wherein the at least one user input element includes a second user input element, wherein the fluid control unit is configured to provide a second fluid, different from the first fluid, to the needle in response to a second signal received from the second user input element.

[0234] Example 27

[0235] The device according to any one of Examples 24 to 26, wherein the at least one user input element includes at least one tactile switch.

[0236] Example 28

[0237] The device according to any one of Examples 21 to 27 further includes at least one user feedback element located on or within the device body, wherein the at least one user feedback element is operatively in communication with the fluid control unit, and wherein the at least one user feedback element is configured to provide at least one form of user feedback in response to at least one signal received from the fluid control unit.

[0238] Example 29

[0239] According to the device of Example 28, the at least one user feedback element includes at least one light-emitting element configured to emit light in response to the at least one signal received from the fluid control unit.

[0240] Example 30

[0241] According to any one of Examples 28 to 29, the device wherein the at least one user feedback element includes a speaker configured to provide audible sound in response to the at least one signal received from the fluid control unit.

[0242] Example 31

[0243] A method comprising: (a) inserting a flexible cannula having a needle retracted therein into a space between the sclera and choroid of an eye; (b) applying a predetermined threshold rotational force to a rotating knob associated with the needle, sufficient to overcome rotational resistance applied to the rotating knob by a deflectable member, such that the rotating knob rotates and thereby advances the needle relative to the cannula while the cannula remains positioned between the sclera and the choroid, such that the needle pierces the choroid to enter the subretinal space of the eye; and (c) delivering a therapeutic agent into the subretinal space via the advanced needle.

[0244] Example 32

[0245] According to the method described in Example 31, the deflectable member is fixed to prevent rotation relative to the rotary knob.

[0246] Example 33

[0247] According to any one of Examples 31 to 32, the method further includes tracking the advance of the needle via a sensor.

[0248] Example 34

[0249] According to the method of Example 33, the method further includes automatically distributing guide bubble fluid through the needle while advancing the needle in response to at least one signal generated by the sensor.

[0250] Example 35

[0251] According to any one of Examples 31 to 34, the method further includes actuating at least one user input element operatively communicating with the fluid control unit.

[0252] Example 36

[0253] According to the method of Example 35, the delivery of the therapeutic agent is performed automatically in response to at least one signal generated by the at least one user input element.

[0254] Example 37

[0255] According to any one of Examples 35 to 36, the method further includes dispensing guide bubble fluid through the needle in response to at least one signal generated by the at least one user input element.

[0256] Example 38

[0257] According to any one of Examples 35 to 37, the method further includes providing at least one form of user feedback in response to at least one signal generated by the fluid control unit.

[0258] Example 39

[0259] According to the method of Example 38, providing at least one form of user feedback includes causing the light-emitting element to emit light.

[0260] Example 40

[0261] According to any one of Examples 38 to 39, providing at least one form of user feedback includes providing an audible sound.

[0262] Example 41

[0263] An apparatus comprising: (a) a first fluid source, the first fluid source including: (i) a first proximal end; (ii) a first distal end configured to dispense bubble fluid; and (iii) a first piston disposed between the first proximal end and the first distal end; (b) a second fluid source, the second fluid source including: (i) a second proximal end; (ii) a second distal end configured to dispense a therapeutic agent; and (iii) a second piston disposed between the second proximal end and the second distal end; (c) a housing including: (i) a first fluid source connector configured to connect the first distal end of the first fluid source to a first fluid conduit; and (ii) a second fluid source connector configured to connect the second distal end of the second fluid source to a second fluid conduit; and (d) a control module including: (i) (ii) a first drive assembly, the first drive assembly including a first electric motor, wherein the first drive assembly is configured to advance the first piston distally along a first longitudinal axis and thereby dispense the foam fluid from the first distal end; and (ii) a second drive assembly, the second drive assembly including a second electric motor, wherein the second drive assembly is configured to advance the second piston distally along a second longitudinal axis and thereby dispense the therapeutic agent from the second distal end, the second longitudinal axis being substantially parallel to the first longitudinal axis.

[0264] Example 42

[0265] The device of claim 41, wherein the control module further includes at least one user input element, wherein at least one of the first drive assembly or the second drive assembly is configured to advance a corresponding first piston or the second piston in response to actuation of the at least one user input element.

[0266] Example 43

[0267] The device of claim 42, wherein the at least one user input element of the control module comprises at least one tactile switch.

[0268] Example 44

[0269] The device according to any one of claims 41 to 43, wherein the control module further includes at least one user feedback element, wherein the at least one user feedback element is configured to provide at least one form of user feedback indicating the state of the device.

[0270] Example 45

[0271] The device of claim 44, wherein the at least one user feedback element comprises at least one of: a light-emitting element configured to emit light in a manner indicating the state of the device; or a speaker configured to provide audible sound in a manner indicating the state of the device.

[0272] Example 46

[0273] The device according to any one of claims 41 to 45, wherein the housing is removably coupled to the control module.

[0274] Example 47

[0275] The device according to any one of claims 41 to 46, wherein the first drive assembly and the second drive assembly include a first linear actuator and a second linear actuator configured to be driven by the first electric motor and the second electric motor, respectively.

[0276] Example 48

[0277] The device according to any one of claims 41 to 47, wherein the first drive assembly and the second drive assembly are configured to independently advance the first piston and the second piston, respectively.

[0278] Example 49

[0279] The device according to any one of claims 41 to 48, wherein at least one of the box or the control module includes a first sensor and a second sensor, the first sensor and the second sensor being configured to generate signals indicating fluid pressure in the first fluid source and the second fluid source, respectively.

[0280] Example 50

[0281] The device of claim 49, wherein the first sensor and the second sensor each comprise at least one of a strain gauge or a pressure transducer.

[0282] Example 51

[0283] The device according to any one of claims 41 to 50 further includes the bubble fluid disposed within the first fluid source.

[0284] Example 52

[0285] The device according to any one of claims 41 to 51 further comprises the therapeutic agent disposed within the second fluid source.

[0286] Example 53

[0287] The device according to any one of claims 41 to 52, wherein at least one of the first fluid source or the second fluid source comprises a syringe.

[0288] Example 54

[0289] The device according to any one of claims 41 to 53, wherein the first fluid source and the second fluid source, the cartridge and the control module together have a total physical volume of less than about 150 mL.

[0290] Example 55

[0291] A system comprising: (a) the device according to any one of claims 41 to 54; and (b) a first fluid conduit and a second fluid conduit, wherein the first fluid conduit and the second fluid conduit are respectively connected to a first distal end and a second distal end of a first fluid source and a second fluid source via a first fluid source connector and a second fluid source connector, respectively.

[0292] Example 56

[0293] The system of claim 55 further includes an instrument comprising: (i) an instrument body; (ii) a cannula extending distally from the instrument body, wherein the cannula is flexible, wherein the cannula is sized and configured to advance between the sclera and choroid of a patient's eye; and (iii) a needle slidably disposed within the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned within the cannula when the needle is in the proximal position, wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position, wherein the needle is fluidly coupled to the first fluid conduit and the second fluid conduit.

[0294] Example 57

[0295] The system of claim 56, wherein the instrument further includes a sensor positioned on or within the instrument body, wherein the sensor is operable to detect the position of the needle relative to the cannula.

[0296] Example 58

[0297] The system of claim 57, wherein one of the first drive assembly or the second drive assembly is configured to advance the corresponding first piston or the second piston in response to the sensor detecting translation of the needle relative to the cannula.

[0298] Example 59

[0299] The system according to any one of claims 56 to 58, wherein the instrument further includes at least one user input element positioned on or within the instrument body, wherein at least one of the first drive assembly or the second drive assembly is configured to advance a corresponding first piston or the second piston in response to actuation of the at least one user input element.

[0300] Example 60

[0301] The system of claim 59, wherein the at least one user input element of the instrument includes a first user input element, wherein the first drive assembly is configured to advance the first piston in response to actuation of the first user input element.

[0302] Example 61

[0303] The system of claim 60, wherein the at least one user input element of the instrument includes a second user input element, wherein the second drive assembly is configured to advance the second piston in response to actuation of the second user input element.

[0304] Example 62

[0305] The system according to any one of claims 59 to 61, wherein the at least one user input element of the device comprises at least one tactile switch.

[0306] Example 63

[0307] The system according to any one of claims 56 to 62, wherein the device is configured to supply power to the apparatus.

[0308] Example 64

[0309] The system according to any one of claims 55 to 63 further includes a wrist rest, wherein the device is mounted to the wrist rest.

[0310] Example 65

[0311] An apparatus comprising: (a) a first fluid source including: (i) a first proximal end; (ii) a first distal end configured to dispense bubble fluid; and (iii) a first piston disposed between the first proximal end and the first distal end, wherein the first piston is configured to advance distally along a first longitudinal axis to dispense the bubble fluid from the first distal end; (b) a second fluid source including: (i) a second proximal end; (ii) a second distal end configured to dispense a therapeutic agent; and (iii) a second piston disposed between the second proximal end and the second distal end, wherein the second piston is configured to advance distally along a second longitudinal axis to dispense the therapeutic agent from the second distal end; and (c) a cartridge including: (i) a first fluid source connector including: (A) a first proximal Luer connector configured to engage with the first distal end of the first fluid source; and (B) (i) a first distal Luer connector configured to connect to a first fluid conduit; and (ii) a second fluid source connector comprising: (A) a second proximal Luer connector configured to connect to a second distal end of a second fluid source; and (B) a second distal Luer connector configured to connect to a second fluid conduit, the first proximal Luer connector and the second proximal Luer connector being configured to orient the first fluid source and the second fluid source such that the first longitudinal axis and the second longitudinal axis are substantially parallel to each other; and (d) a control module comprising: (i) a first drive assembly configured to advance the first piston distally along the first longitudinal axis and thereby dispense the bubble fluid from the first distal end; and (ii) a second drive assembly configured to advance the second piston distally along the second longitudinal axis and thereby dispense the therapeutic agent from the second distal end.

[0312] Example 66

[0313] An apparatus comprising: (a) a first fluid source containing a foaming fluid; (b) a second fluid source containing a therapeutic agent; (c) a cartridge configured to connect the first fluid source and the second fluid source to a first fluid conduit and a second fluid conduit, respectively; and (d) a control module comprising: (i) a first drive assembly including: (A) a first linear actuator including a first lead screw; and (B) a first electric motor configured to drive the first linear actuator to cause the first lead screw to translate distally along a first longitudinal axis and thereby dispense the foaming fluid from the first fluid source; and (ii) a second drive assembly including: (A) a second linear actuator including a second lead screw; and (B) a second electric motor configured to drive the second linear actuator to cause the second lead screw to translate distally along a second longitudinal axis and thereby dispense the foaming fluid from the second fluid source, the second longitudinal axis being substantially parallel to the first longitudinal axis.

[0314] Example 67

[0315] A method comprising: (a) coupling a first syringe and a second syringe to a cartridge, the first syringe and the second syringe being filled with a foaming fluid and a therapeutic agent, respectively; (b) sliding at least one guide member of the cartridge along at least one corresponding guide member of a control module; and (c) engaging at least one connecting member of the cartridge with at least one corresponding connecting member of the control module to thereby attach the cartridge to the control module, wherein when the cartridge is attached to the control module, the first syringe and the second syringe are aligned with a first drive assembly and a second drive assembly of the control module, respectively.

[0316] Example 68

[0317] According to the method of Example 67, connecting the first syringe and the second syringe to the housing includes screwing the distal ends of the first syringe and the second syringe to corresponding Luer connectors of the housing.

[0318] Example 69

[0319] According to any one of Examples 67 to 68, the method wherein coupling the first syringe and the second syringe to the cartridge includes oriented the first syringe and the second syringe to be substantially parallel to each other.

[0320] Example 70

[0321] The method according to any one of Examples 67 to 69 further includes filling the at least one of the first syringe or the second syringe with the foam fluid or the therapeutic agent, respectively, before connecting at least one of the first syringe or the second syringe to the cartridge.

[0322] Example 71

[0323] According to the method of Example 70, filling at least one of the first syringe or the second syringe includes retracting the corresponding plunger rod proximally to draw the bubbly fluid or the therapeutic agent from the vial into at least one of the first syringe or the second syringe.

[0324] Example 72

[0325] According to the method of Example 71, it further includes, after filling at least one of the first syringe or the second syringe and before connecting the at least one of the first syringe or the second syringe to the cartridge, disengaging the corresponding plunger rod from the corresponding plug contained in the at least one of the first syringe or the second syringe.

[0326] Example 73

[0327] According to any one of Examples 70 to 72, filling at least one of the first syringe or the second syringe comprises drawing the foam fluid or the therapeutic agent into at least one of the first syringe or the second syringe via a corresponding needle.

[0328] Example 74

[0329] The method according to Example 73 further includes, after filling at least one of the first syringe or the second syringe and before coupling the at least one of the first syringe or the second syringe to the cartridge, disengaging the corresponding needle from the distal end of the at least one of the first syringe or the second syringe.

[0330] Example 75

[0331] The method according to any one of Examples 67 to 74 further includes operatively coupling the control module to an instrument comprising: (i) an instrument body; (ii) a cannula extending distally from the instrument body, wherein the cannula is flexible, wherein the cannula is sized and configured to advance between the sclera and choroid of a patient's eye; and (iii) a needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position.

[0332] Example 76

[0333] According to the method of Example 75, operatively connecting the control module to the instrument includes placing a circuit board assembly of the fluid control module in operative communication with a circuit board assembly of the instrument.

[0334] Example 77

[0335] According to any one of Examples 75 to 76, operably coupling the control module to the instrument includes fluidly coupling the needle to the first syringe and the second syringe.

[0336] Example 78

[0337] According to any one of Examples 67 to 77, the at least one guide member of the box or the at least one corresponding guide member of the control module includes at least one of a track or a groove.

[0338] Example 79

[0339] According to the method of any one of Examples 67 to 78, the at least one connecting member of the box or the at least one corresponding connecting member of the control module includes a spring-loaded latch.

[0340] Example 80

[0341] The method according to any one of Examples 67 to 79 further includes disengaging the at least one connecting member of the box from the at least one corresponding connecting member of the control module to thereby detach the box from the control module.

[0342] VI. Other

[0343] It should be understood that any version of the apparatus described herein may include various other features besides or in lieu of the foregoing features. By way of example only, any device herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

[0344] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc., should not be viewed in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art in light of the teachings herein. These modifications and variations are intended to be included within the scope of the claims.

[0345] It should be understood that any patent publications or other disclosures deemed to be incorporated herein by reference are incorporated wholly or in part only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosures set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly set forth herein supersede any conflicting material incorporated herein by reference. Any material or portion thereof deemed to be incorporated herein by reference but conflicting with existing definitions, statements, or other disclosures set forth herein will be incorporated only to the extent that the incorporated material does not conflict with existing disclosures.

[0346] The aforementioned version may be designed to be discarded after a single use, or it may be configured for multiple uses. In either case, the version may be adjusted for reuse after at least one use. Adjustment may include any combination of steps such as disassembling the device, subsequently cleaning or replacing specific components, and subsequently reassembling. Specifically, 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. After cleaning and / or replacing specific components, some versions of the device may be reassembled at the adjustment facility for subsequent use, or reassembled by an operator immediately before surgery. Those skilled in the art will understand that the adjustment of the device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting adjusted device are within the scope of this application.

[0347] By way of example only, the version described herein can be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterilized container for later use. The device can also be sterilized using any other techniques known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0348] Various embodiments of the invention have been shown and described. Further modifications to the methods and systems described herein can be made by those skilled in the art through appropriate modifications without departing from the scope of the invention. Several such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the appended claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus comprising: (a) The main body of the instrument; (b) Intubation, the intubation extending distally from the instrument body, wherein the intubation is flexible, and wherein the intubation is sized and configured to advance between the sclera and choroid of the patient's eye. (c) A needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position. (d) A rotary knob configured to rotate about a rotation axis relative to the instrument body and thereby drive the needle to translate between the proximal and distal positions; as well as (e) At least one deflectable member, said at least one deflectable member being fixed to prevent rotation relative to one of the instrument body or the rotary knob, said at least one deflectable member being configured to frictionally engage the other of the instrument body or the rotary knob to prevent the rotary knob from rotating about the rotation axis without a predetermined threshold rotational force being applied to the rotary knob.

2. The device of claim 1, wherein the at least one deflectable member is fixed to prevent rotation relative to the rotary knob, wherein the at least one deflectable member is configured to frictionally engage the device body to prevent the rotary knob from rotating about the rotation axis without the predetermined threshold rotational force being applied to the rotary knob.

3. The device of claim 2, wherein the at least one deflectable member is configured to deflect radially inward relative to the axis of rotation from a non-deflected state to a deflected state, wherein the at least one deflectable member is elastically biased toward the non-deflected state.

4. The device according to any one of claims 2 to 3, wherein the instrument body is configured to push the at least one deflectable member toward the deflection state.

5. The device according to any one of claims 2 to 4, wherein the device includes a protrusion, wherein the protrusion is configured to push the at least one deflectable member toward the deflected state.

6. The device according to any one of claims 1 to 5, wherein the at least one deflectable member comprises a plurality of deflectable members.

7. The device of claim 6, wherein the plurality of deflectable members are circumferentially spaced apart from each other at equal intervals.

8. The device according to any one of claims 6 to 7, wherein the plurality of deflectable members comprises three deflectable members.

9. The device according to any one of claims 1 to 8, wherein the at least one deflectable member comprises at least one deflectable beam.

10. The device of claim 9, wherein the at least one deflectable beam is defined by at least a pair of recesses.

11. The device according to any one of claims 9 to 10, wherein the at least one deflectable beam includes at least one stop extending radially outward from the radially outer surface of the at least one deflectable beam, wherein the at least one stop is configured to frictionally engage the device body.

12. The device according to any one of claims 1 to 11, further comprising a torque ring, wherein the torque ring includes the at least one deflectable member.

13. The device of claim 12, wherein the rotary knob includes a first interlocking member, and wherein the torque ring includes a second interlocking member configured to interlock with the first interlocking member to fix the torque ring to prevent rotation relative to the rotary knob.

14. The device of claim 13, wherein one of the first interlocking member or the second interlocking member comprises a post, wherein the other of the first interlocking member or the second interlocking member comprises a recess configured to receive the post and thereby interlock with the post.

15. The device according to any one of claims 12 to 14, wherein the rotary knob defines an interior, and wherein the torque ring is at least partially disposed within the interior of the rotary knob.

16. An apparatus comprising: (a) The main body of the instrument; (b) Intubation, the intubation extending distally from the instrument body, wherein the intubation is flexible, and wherein the intubation is sized and configured to advance between the sclera and choroid of the patient's eye. (c) A needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position. (d) Rotating a knob, the rotating knob being configured to drive the needle to translate between the proximal position and the distal position; as well as (e) Torque ring, which is configured to resist rotation of the rotary knob.

17. The device of claim 16, wherein the torque ring is fixed to prevent rotation relative to either the instrument body or the rotary knob.

18. The device of claim 17, wherein the torque ring is integrally formed as a single piece together with either the instrument body or the rotary knob.

19. The device according to any one of claims 17 to 18, wherein the torque ring is fixed to prevent rotation relative to the rotary knob.

20. The device according to any one of claims 16 to 19, wherein the torque ring includes at least one deflectable member configured to provide friction between the rotary knob and the device body.

21. An apparatus comprising: (a) The main body of the instrument; (b) Intubation, the intubation extending distally from the instrument body, wherein the intubation is flexible, and wherein the intubation is sized and configured to advance between the sclera and choroid of the patient's eye. (c) A needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position. (d) A knob configured to rotate relative to the instrument body and thereby drive the needle to translate between the proximal position and the distal position; (e) At least one deflectable member, the at least one deflectable member being configured to frictionally engage one of the instrument body or the knob to prevent the knob from rotating without a predetermined threshold rotational force being applied to the knob; as well as (f) A fluid control unit configured to supply at least one fluid to the needle.

22. The device of claim 21, further comprising a sensor positioned on or within the device body, wherein the sensor is operatively in communication with the fluid control unit, wherein the sensor is operable to detect the position of the needle relative to the cannula.

23. The device of claim 22, wherein the fluid control unit is configured to supply the at least one fluid to the needle in response to a signal received from the sensor.

24. The device according to any one of claims 21 to 23, further comprising at least one user input element located on or within the device body, wherein the at least one user input element is operatively in communication with the fluid control unit, wherein the fluid control unit is configured to supply the at least one fluid to the needle in response to at least one signal received from the at least one user input element.

25. The device of claim 24, wherein the at least one user input element includes a first user input element, wherein the fluid control unit is configured to supply a first fluid to the needle in response to a first signal received from the first user input element.

26. The device of claim 25, wherein the at least one user input element includes a second user input element, wherein the fluid control unit is configured to provide a second fluid, different from the first fluid, to the needle in response to a second signal received from the second user input element.

27. The device according to any one of claims 24 to 26, wherein the at least one user input element comprises at least one tactile switch.

28. The device according to any one of claims 21 to 27, further comprising at least one user feedback element located on or within the device body, wherein the at least one user feedback element is operatively communicateable with the fluid control unit, wherein the at least one user feedback element is configured to provide at least one form of user feedback in response to at least one signal received from the fluid control unit.

29. The device of claim 28, wherein the at least one user feedback element comprises at least one light-emitting element configured to emit light in response to the at least one signal received from the fluid control unit.

30. The device according to any one of claims 28 to 29, wherein the at least one user feedback element includes a speaker configured to provide audible sound in response to the at least one signal received from the fluid control unit.

31. A method comprising: (a) Inserting a flexible cannula with a retractable needle into the space between the sclera and choroid of the eye; (b) Applying a predetermined threshold rotational force to a rotating knob associated with the needle, sufficient to overcome rotational resistance applied to the rotating knob by a deflectable member, to rotate the rotating knob and thereby advance the needle relative to the cannula, while the cannula remains positioned between the sclera and the choroid, such that the needle pierces the choroid to enter the subretinal space of the eye; and (c) Delivering the therapeutic agent into the subretinal space via an advancing needle.

32. The method of claim 31, wherein the deflectable member is fixed to prevent rotation relative to the rotary knob.

33. The method according to any one of claims 31 to 32, further comprising tracking the advance of the needle via a sensor.

34. The method of claim 33, further comprising automatically dispensing guide bubble fluid through the needle while advancing the needle in response to at least one signal generated by the sensor.

35. The method according to any one of claims 31 to 34, further comprising actuating at least one user input element operatively in communication with the fluid control unit.

36. The method of claim 35, wherein delivery of the therapeutic agent is performed automatically in response to at least one signal generated by the at least one user input element.

37. The method according to any one of claims 35 to 36, further comprising dispensing guide bubble fluid through the needle in response to at least one signal generated by the at least one user input element.

38. The method according to any one of claims 35 to 37, further comprising providing at least one form of user feedback in response to at least one signal generated by the fluid control unit.

39. The method of claim 38, wherein providing at least one form of user feedback comprises causing the light-emitting element to emit light.

40. The method according to any one of claims 38 to 39, wherein providing at least one form of user feedback includes providing an audible sound.

41. An apparatus comprising: (a) a first fluid source, the first fluid source comprising: (i) First proximal end; (ii) a first distal end, the first distal end being configured to dispense bubble fluid; and (iii) A first piston, the first piston being disposed between the first proximal end and the first distal end; (b) a second fluid source, the second fluid source comprising: (i) Second proximal end; (ii) a second distal end, the second distal end being configured to dispense a therapeutic agent; and (iii) A second piston, the second piston being disposed between the second proximal end and the second distal end; (c) a box, the box comprising: (i) a first fluid source connector, the first fluid source connector being configured to connect the first distal end of the first fluid source to a first fluid conduit; and (ii) a second fluid source connector, the second fluid source connector being configured to connect the second distal end of the second fluid source to a second fluid conduit; and (d) A control module, the control module comprising: (i) a first drive assembly, the first drive assembly including a first electric motor, wherein the first drive assembly is configured to advance the first piston distally along a first longitudinal axis and thereby dispense the bubble fluid from the first distal end; and (ii) A second drive assembly comprising a second electric motor, wherein the second drive assembly is configured to advance the second piston distally along a second longitudinal axis and thereby dispense the therapeutic agent from the second distal end, the second longitudinal axis being substantially parallel to the first longitudinal axis.

42. The device of claim 41, wherein the control module further includes at least one user input element, wherein at least one of the first drive assembly or the second drive assembly is configured to advance a corresponding first piston or second piston in response to actuation of the at least one user input element.

43. The device of claim 42, wherein the at least one user input element of the control module comprises at least one tactile switch.

44. The device according to any one of claims 41 to 43, wherein the control module further comprises at least one user feedback element, wherein the at least one user feedback element is configured to provide at least one form of user feedback indicating the state of the device.

45. The device of claim 44, wherein the at least one user feedback element comprises at least one of: a light-emitting element configured to emit light in a manner indicating the state of the device; or a speaker configured to provide audible sound in a manner indicating the state of the device.

46. ​​The device according to any one of claims 41 to 45, wherein the housing is removably coupled to the control module.

47. The device according to any one of claims 41 to 46, wherein the first drive assembly and the second drive assembly include a first linear actuator and a second linear actuator configured to be driven by the first electric motor and the second electric motor, respectively.

48. The device according to any one of claims 41 to 47, wherein the first drive assembly and the second drive assembly are configured to independently advance the first piston and the second piston, respectively.

49. The device according to any one of claims 41 to 48, wherein at least one of the box or the control module includes a first sensor and a second sensor, the first sensor and the second sensor being configured to generate signals indicating fluid pressure in the first fluid source and the second fluid source, respectively.

50. The device of claim 49, wherein the first sensor and the second sensor each comprise at least one of a strain gauge or a pressure transducer.

51. The device according to any one of claims 41 to 50, further comprising the bubble fluid disposed within the first fluid source.

52. The device according to any one of claims 41 to 51, further comprising the therapeutic agent disposed within the second fluid source.

53. The device according to any one of claims 41 to 52, wherein at least one of the first fluid source or the second fluid source comprises a syringe.

54. The device according to any one of claims 41 to 53, wherein the first fluid source and the second fluid source, the cartridge and the control module together have a total physical volume of less than about 150 mL.

55. A system comprising: (a) The device according to any one of claims 41 to 54; as well as (b) The first fluid conduit and the second fluid conduit, wherein the first fluid conduit and the second fluid conduit are respectively connected to the first distal end and the second distal end of the first fluid source and the second fluid source via the first fluid source connector and the second fluid source connector, respectively.

56. The system of claim 55, further comprising an instrument, the instrument comprising: (i) The main body of the device; (ii) Intubation, the cannula extending distally from the instrument body, wherein the cannula is flexible, and wherein the cannula is sized and configured to advance between the sclera and choroid of the patient's eye. as well as (iii) A needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position, wherein the needle is fluidly connected to the first fluid conduit and the second fluid conduit.

57. The system of claim 56, wherein the instrument further comprises a sensor positioned on or within the instrument body, wherein the sensor is operable to detect the position of the needle relative to the cannula.

58. The system of claim 57, wherein one of the first drive assembly or the second drive assembly is configured to advance the corresponding first piston or the second piston in response to the sensor detecting translation of the needle relative to the cannula.

59. The system according to any one of claims 56 to 58, wherein the instrument further comprises at least one user input element positioned on or within the instrument body, wherein at least one of the first drive assembly or the second drive assembly is configured to advance a corresponding first piston or the second piston in response to actuation of the at least one user input element.

60. The system of claim 59, wherein the at least one user input element of the instrument includes a first user input element, wherein the first drive assembly is configured to advance the first piston in response to actuation of the first user input element.

61. The system of claim 60, wherein the at least one user input element of the instrument includes a second user input element, wherein the second drive assembly is configured to advance the second piston in response to actuation of the second user input element.

62. The system according to any one of claims 59 to 61, wherein the at least one user input element of the device comprises at least one tactile switch.

63. The system according to any one of claims 56 to 62, wherein the device is configured to supply power to the apparatus.

64. The system according to any one of claims 55 to 63, further comprising a wrist rest, wherein the device is mounted to the wrist rest.

65. An apparatus comprising: (a) a first fluid source, the first fluid source comprising: (i) First proximal end; (ii) a first distal end, the first distal end being configured to dispense bubble fluid; and (iii) A first piston disposed between the first proximal end and the first distal end, wherein the first piston is configured to advance distally along a first longitudinal axis to dispense the bubble fluid from the first distal end; (b) a second fluid source, the second fluid source comprising: (i) Second proximal end; (ii) a second distal end, the second distal end being configured to dispense a therapeutic agent; and (iii) A second piston disposed between the second proximal end and the second distal end, wherein the second piston is configured to advance distally along a second longitudinal axis to dispense the therapeutic agent from the second distal end; (c) a box, the box comprising: (i) a first fluid source connector, the first fluid source connector comprising: (A) A first proximal Luer connector, configured to connect to the first distal end of the first fluid source; and (B) A first distal Luer connector, configured to connect to a first fluid conduit; and (ii) a second fluid source connector, the second fluid source connector comprising: (A) A second proximal Luer connector, configured to connect to the second distal end of the second fluid source; and (B) A second distal Luer connector, configured to connect to a second fluid conduit. The first proximal Luer connector and the second proximal Luer connector are configured to orient the first fluid source and the second fluid source such that the first longitudinal axis and the second longitudinal axis are substantially parallel to each other; and (d) A control module, the control module comprising: (i) a first drive assembly, wherein the first drive assembly is configured to advance the first piston distally along the first longitudinal axis and thereby dispense the bubble fluid from the first distal end; and (ii) A second drive assembly, wherein the second drive assembly is configured to advance the second piston distally along the second longitudinal axis and thereby dispense the therapeutic agent from the second distal end.

66. An apparatus comprising: (a) A first fluid source, the first fluid source containing a bubble fluid; (b) A second fluid source containing a therapeutic agent; (c) A box configured to connect the first fluid source and the second fluid source to a first fluid conduit and a second fluid conduit, respectively; as well as (d) A control module, the control module comprising: (i) a first driving component, the first driving component comprising: (A) A first linear actuator, the first linear actuator including a first lead screw; and (B) A first electric motor configured to drive the first linear actuator to cause the first lead screw to translate distally along a first longitudinal axis and thereby dispense the bubble fluid from the first fluid source; and (ii) a second driving component, the second driving component comprising: (A) A second linear actuator, the second linear actuator including a second lead screw; and (B) A second electric motor configured to drive the second linear actuator to cause the second lead screw to translate distally along a second longitudinal axis and thereby dispense the bubble fluid from the second fluid source, the second longitudinal axis being substantially parallel to the first longitudinal axis.

67. A method comprising: (a) Connecting a first syringe and a second syringe to a cartridge, wherein the first syringe and the second syringe are respectively filled with foam fluid and a therapeutic agent; (b) Slide at least one guide member of the box along at least one corresponding guide member of the control module; as well as (c) Engaging at least one connecting member of the box with at least one corresponding connecting member of the control module to thereby attach the box to the control module. When the box is attached to the control module, the first syringe and the second syringe are aligned with the first drive component and the second drive component of the control module, respectively.

68. The method of claim 67, wherein connecting the first syringe and the second syringe to the housing comprises screwing the distal ends of the first syringe and the second syringe to corresponding Luer connectors of the housing.

69. The method of any one of claims 67 to 68, wherein coupling the first syringe and the second syringe to the cartridge comprises orienting the first syringe and the second syringe to be substantially parallel to each other.

70. The method according to any one of claims 67 to 69, further comprising filling the first syringe or the second syringe with the foam fluid or the therapeutic agent, respectively, before connecting at least one of the first syringe or the second syringe to the cartridge.

71. The method of claim 70, wherein filling at least one of the first syringe or the second syringe comprises retracting the corresponding plunger proximally to draw the bubble fluid or the therapeutic agent from the vial into at least one of the first syringe or the second syringe.

72. The method of claim 71, further comprising, after filling at least one of the first syringe or the second syringe and before connecting the at least one of the first syringe or the second syringe to the cartridge, disengaging the corresponding plunger rod from the corresponding plug contained in the at least one of the first syringe or the second syringe.

73. The method according to any one of claims 70 to 72, wherein filling at least one of the first syringe or the second syringe comprises drawing the foam fluid or the therapeutic agent into at least one of the first syringe or the second syringe via a corresponding needle.

74. The method of claim 73, further comprising, after filling at least one of the first syringe or the second syringe and before coupling the at least one of the first syringe or the second syringe to the cartridge, disengaging the corresponding needle from the distal end of the at least one of the first syringe or the second syringe.

75. The method according to any one of claims 67 to 74, further comprising operatively coupling the control module to an instrument, the instrument comprising: (i) The main body of the device; (ii) Intubation, the cannula extending distally from the instrument body, wherein the cannula is flexible, and wherein the cannula is sized and configured to advance between the sclera and choroid of the patient's eye. as well as (iii) A needle slidably disposed in the cannula, wherein the needle includes a sharp distal tip, wherein the needle is configured to translate relative to the cannula between a proximal position and a distal position, wherein the distal tip is configured to be positioned inside the cannula when the needle is in the proximal position, and wherein the distal tip is configured to be positioned outside the cannula when the needle is in the distal position.

76. The method of claim 75, wherein operatively connecting the control module to the instrument comprises positioning a circuit board assembly of the fluid control module in operative communication with a circuit board assembly of the instrument.

77. The method according to any one of claims 75 to 76, wherein operatively connecting the control module to the instrument comprises fluidly connecting the needle to the first syringe and the second syringe.

78. The method according to any one of claims 67 to 77, wherein the at least one guide member of the box or the at least one corresponding guide member of the control module comprises at least one of a track or a groove.

79. The method according to any one of claims 67 to 78, wherein the at least one connecting member of the box or the at least one corresponding connecting member of the control module comprises a spring-loaded latch.

80. The method according to any one of claims 67 to 79, further comprising disengaging the at least one connecting member of the box from the at least one corresponding connecting member of the control module to thereby detach the box from the control module.

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