Methods and apparatus for subretinal injection

Abstract

In certain embodiments, an apparatus for performing a subretinal injection into a subretinal space between a retina and retinal pigment epithelium of an eye is provided. The apparatus includes an injection needle (110) having a proximal end (112) and a distal end (114) configured to be inserted into the subretinal space at a location on a surface of the retina. The apparatus includes a multi-lumen tube (120) having a distal end (122) coupled to the proximal end (112) of the injection needle (110) and a proximal end coupled to a fluid control unit. The apparatus includes a stabilizer (130) configured to secure the injection needle (110) at the location on the surface of the retina. The fluid control unit has a plurality of fluid reservoirs containing a non-treatment solution, a treatment solution, and a working fluid that are injectable into the eye via separate lumens (128a, 128b, 128c) of the multi-lumen tube (120).

Description

[0001] CLAIM OF PRIORITY

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 141,051, filed January 25, 2021, entitled “METHOD AND APPARATUS FOR SUBRETINAL INJECTION,” which is hereby incorporated herein by reference in its entirety as if fully and completely set forth herein. background Technical Field

[0004] The embodiments of this disclosure generally relate to devices for ophthalmic treatment, and more particularly, to an apparatus and method for performing subretinal injection. Subretinal injection generally refers to the injection of a fluid or other therapeutic substance or stem cells into the subretinal space between the retina and the retinal pigment epithelium (RPE) of the eye.

[0005] Description of related fields

[0006] Certain eye diseases can be treated by subretinal injections, including, for example, age-related macular degeneration (AMD) and retinal degenerative diseases, as well as genetic defects. Typical practice requires at least two people to perform subretinal injections. For example, the attending surgeon can guide the injection instrument (e.g., syringe / needle) and visually monitor the injection site, while a skilled surgical assistant dispenses the fluid from the syringe and monitors the injection volume. Accordingly, typically, the first syringe is equipped with a small-gauge needle and contains a non-therapeutic fluid, such as balanced salt solution (BSS). In the first step of the procedure, the first syringe is inserted through the retina into the subretinal space. While the surgeon manipulates the first syringe and visually monitors the injection site, the assistant manually injects the non-therapeutic fluid and monitors the injection volume. Next, the first syringe is removed from the eye.

[0007] The second syringe is equipped with a small-gauge needle and contains a therapeutic fluid, such as a therapeutic agent. In the second step of the procedure, the second syringe is inserted into the subretinal space through the retina at approximately the same location as the first syringe. While the surgeon manipulates the second syringe and visually monitors the injection site, an assistant manually injects the therapeutic fluid and monitors the injection volume. Therefore, there are many disadvantages to manually controlling the injection in a two-step process using a handheld injection device. Some of these disadvantages are described below.

[0008] First, injecting with a handheld injection device as described above can cause retinal tears. In particular, retinal tears can be caused by unintentional movement of the injection syringe / needle due to external forces from outside the eye when inserting the needle through the retina. The external forces can include unintentional movement by the surgeon during manipulation of the injection device or unintentional movement by an assistant during manual control of fluid injection.

[0009] Further, manual control of fluid injection as described above can have many additional drawbacks. Typically, manual control of fluid injection includes manually depressing the plunger. For example, manual control of fluid injection can result in an incorrect injection volume, which can result in overdosing or underdosing or overstretching of the retina. In another example, manual control of fluid injection can result in a high flow rate into the subretinal space, which can damage the retina or RPE, for example, causing rhegmatogenous retinal detachment with retinal morphological changes or RPE atrophy. In yet another example, manual control of fluid injection can result in high shear forces in the needle, which can be detrimental to the biological activity of various therapeutic agents (e.g., drugs, stem cells, viral vectors) carried by the injection fluid.

[0010] Additionally, removing the first needle and inserting the second needle through the retina as described above can have additional drawbacks. For example, multiple insertions through the retina can have an impact on retinal tears. In another example, creating two different holes in the retina (one for each injection step) increases the likelihood of fluid leakage from the subretinal space.

[0011] Each of the above issues can have a negative impact on the ophthalmic treatment being performed and / or increase the safety risk. Accordingly, there is a need in the art for improved devices for ophthalmic treatment, including improved apparatus and methods for subretinal injection. SUMMARY

[0012] The present disclosure relates generally to devices for ophthalmic treatment, and more particularly, to an apparatus and method for performing subretinal injection.

[0013] In certain embodiments, an apparatus for performing a subretinal injection into a subretinal space between a retina and a retinal pigment epithelium of an eye is provided. The apparatus includes an injection needle having a proximal end and a distal end configured to be inserted into the subretinal space at a location on a surface of the retina. The apparatus includes a multi-lumen tube having a distal end coupled to the proximal end of the injection needle and a proximal end coupled to a fluid control unit, the multi-lumen tube having a first lumen and a second lumen. The apparatus includes a stabilizer configured to secure the injection needle at the location on the surface of the retina. The fluid control unit has a first fluid reservoir containing a non-treatment solution and a second fluid reservoir containing a treatment solution. The fluid control unit is configured to inject the non-treatment solution from the first fluid reservoir into the subretinal space via the first lumen and to inject the treatment solution from the second fluid reservoir into the subretinal space via the second lumen.

[0014] In certain embodiments, a method for performing a subretinal injection into a subretinal space between a retina and a retinal pigment epithelium of an eye is disclosed. The method includes inserting a distal end of an injection needle into the subretinal space at a location on a surface of the retina, the injection needle having a proximal end coupled to a distal end of a multi-lumen tube, the multi-lumen tube having a proximal end coupled to a fluid control unit. The method includes securing the injection needle at the location on the surface of the retina by applying pressure or fluid through a first lumen of the multi-lumen tube to extend a stabilizer beyond a distal end of the first lumen to contact the surface of the retina. The method includes injecting a non-treatment solution from the fluid control unit into the subretinal space via a second lumen of the multi-lumen tube. The method includes injecting a treatment solution into the subretinal space via a third lumen of the multi-lumen tube using the fluid control unit. BRIEF DESCRIPTION OF DRAWINGS

[0015] In order that the foregoing aspects and features of the present disclosure can be understood in detail, a more particular description will be rendered by reference to example embodiments thereof which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only example embodiments, and are therefore not to be considered as limiting the scope, as the disclosure can admit to other equally effective embodiments.

[0016] FIG. 1A is a schematic illustration of an example injection apparatus for performing a subretinal injection in accordance with certain embodiments.

[0017] FIG. 1B is a cross-sectional view of a portion of an eye illustrating a retina and a retinal pigment epithelium.

[0018] FIG. 1C is an enlarged side view cross-sectional view taken along section line FIG. 1A of FIG. 4, illustrating an example multi-lumen tube in accordance with certain embodiments.

[0019] FIG. 1D is a top isometric view of a portion of an injection device of FIG. 1A

[0020] FIG. 2A is a schematic of an exemplary inserter device according to certain embodiments, which can be used in combination with the injection devices described herein.

[0021] FIG. 2B is a schematic of another exemplary inserter device according to certain embodiments, which can be used in combination with the injection devices described herein.

[0022] FIG. 2C is a schematic of an injection device according to certain embodiments, illustrating an exemplary inserter device in combination with the injection device. FIG. 1A

[0023] FIG. 2D is an enlarged side cross-sectional view of a portion of an injection device of FIG. 2C

[0024] FIG. 3 is an isometric view of an exemplary injection device for performing a subretinal injection in use during operation according to certain embodiments.

[0025] FIG. 4 is a diagram illustrating a method of performing a subretinal injection according to certain embodiments.

[0026] FIG. 5A , FIG. 6A , FIG. 7A , FIG. 8A , FIG. 9A , FIG. 10A , FIG. 11A and FIG. 12A are cross-sectional views of an eye under different operations of a method of FIG. 4

[0027] FIG. 5B , FIG. 6B , FIG. 7B , FIG. 8B , FIG. 9B , FIG. 10B , FIG. 11B and FIG. 12B are, respectively, cross-sectional views of an eye along FIG. 5A , FIG. 6A , FIG. 7A , FIG. 8A , FIG. 9A , FIG. 10A , FIG. 11A and​​​​FIG. 12A A cross-sectional view taken from the cross-section line.

[0028] FIG. 7C According to certain embodiments FIG. 7A A magnified cross-sectional view of a portion of the image shows an exemplary stabilizer that can be used with the injection device described herein.

[0029] FIG. 9C According to certain embodiments FIG. 9A A magnified cross-sectional view of a portion of the image shows the formation of vacuoles in the subretinal cavity.

[0030] FIG. 13A This is an isometric view of another exemplary injection needle according to certain embodiments, which can be used with the injection device described herein.

[0031] FIG. 13B According to certain embodiments FIG. 13A A side-view cross-sectional view of the injection needle shows the injection needle inserted into the subretinal cavity.

[0032] FIG. 14A This is an isometric view of yet another exemplary injection needle according to certain embodiments, which can be used with the injection device described herein.

[0033] FIG. 14B According to certain embodiments FIG. 14A A side-view cross-sectional view of the injection needle shows the injection needle inserted into the subretinal cavity.

[0034] FIG. 15 This is a top isometric view of another exemplary stabilizer according to certain embodiments, which can be used with the injection device described herein.

[0035] FIG. 16 This is a top isometric view of yet another exemplary stabilizer according to certain embodiments, which can be used with the injection device described herein.

[0036] FIG. 17 This is a top isometric view of yet another exemplary stabilizer according to certain embodiments, which can be used with the injection device described herein.

[0037] FIG. 18 This is a schematic diagram of an exemplary guidewire according to certain embodiments, which can be used with the injection device described herein.

[0038] For ease of understanding, the same reference numerals have been used where possible to refer to the same elements common to the figures. It is conceivable that elements and features of one embodiment may be advantageously combined with those of other embodiments without further description. Detailed Implementation

[0039] This disclosure generally relates to devices for ophthalmic treatment, and more particularly to a device and method for performing subretinal injections.

[0040] The embodiments of this disclosure describe a device for performing subretinal injections. Generally, the device includes an injection needle attached to a tube that can be secured within the eye using a stabilizer, eliminating the need to hold the injection instrument throughout the procedure. This prevents unwanted movement of the injection needle that would otherwise occur when holding the injection instrument. Furthermore, the device's tube is connected to a fluid pump external to the eye to automate the actual fluid injection process. Automated fluid injection improves control over the injection volume and control over important flow-related parameters of the injected fluid compared to manual control. Additionally, the device's tube is a multi-lumen tube that provides multiple parallel flow paths from individual fluid reservoirs to the injection needle, allowing injection to be performed using only a single needle. Inserting only one needle through the retina reduces retinal damage that could otherwise result from repeated retinal punctures.

[0041] FIG. 1A This is a schematic diagram of an exemplary injection device 100 for performing subretinal injections. FIG. 1B This is a cross-sectional view of a portion of the eye 10. Therefore, for clarity, it is described together in this article. FIGS. 1A-1B Specifically, the injection device 100 is configured to inject into the eye 10 ( FIG. 1B Subretinal injection is performed in the subretinal space 50 between the retina 20 and the retinal pigment epithelium (RPE) 30. For example... FIG. 1A As shown, the injection device 100 generally includes an injection needle 110, a multi-lumen tube 120, a stabilizer 130, and a fluid control unit 140.

[0042] refer to FIG. 1A The injection needle 110 has a proximal end 112 and a distal end 114. The distal end 114 of the injection needle 110 is configured to be positioned at the retina 20 ( FIG. 1B The needle 110 is inserted into the subretinal cavity 50 at a target location on surface 22. The injection needle 110 includes a connector 116 (described in more detail below) at its proximal end 112, which connects the injection needle 110 to the multi-lumen cannula 120. The multi-lumen cannula 120 has a distal end 122 attached to the proximal end 112 of the injection needle 110 via the connector 116 and a proximal end 124 attached to the fluid control unit 140.

[0043] FIG. 1C It is along FIG. 1AAn enlarged side cross-sectional view, taken from a cross-sectional line, shows an exemplary multi-lumen tube 120. The multi-lumen tube 120 includes an outer wall 126o surrounding three lumens 128a, 128b, and 128c. Although FIG. 1C Three lumens are shown, but more or fewer lumens can be used (e.g., two or more lumens, two to four lumens, two lumens, or four lumens). Lumens 128a-c are separated by an inner wall 126i that intersects with the outer wall 126o. Lumens 128a-c radially surround the central longitudinal axis 120x of the multi-lumen tube 120. FIG. 1C In some embodiments, one or more of the lumens 128a-c have different sizes. For example, each of the lumens 128a, 128b extends one-quarter of the length of the multi-lumen tube 120 in the circumferential direction. On the other hand, lumen 128c extends half the length of the multi-lumen tube 120 in the circumferential direction. Therefore, in FIG. 1C In some embodiments, the volume of lumen 128c may be twice the volume of each of lumens 128a and 128b. In some other embodiments, each of lumens 128a-c has the same size. In some embodiments, the multi-lumen tube 120 is formed of a polymer, such as silicone, polyurethane (PUR), polyamide (PA) (e.g., nylon), polyethylene (PE), polyether block amide (PEBA), polytetrafluoroethylene (PTFE), polyimide (PI), fluorinated ethylene propylene (FEP), perfluoroalkoxyalkane (PFA), polyether ether ketone (PEEK), liquid crystal polymer (LCP), ethylene-tetrafluoroethylene copolymer (ETFE), terpolymer of tetrafluoroethylene, hexafluoropropylene, and vinylidene fluoride (THV), thermoplastic elastomer (TPE), or combinations thereof. In some embodiments, the injection needle 110 and the multi-lumen tube 120 are formed of the same or different materials.

[0044] The fluid control unit 140 includes a fluid pump 142 for driving flow through the multi-lumen tube 120. Although FIG. 1A A syringe pump is shown, but the fluid pump 142 may include at least one of the following pumps: a vernier flow control (VFC) pump or another type of pressure control pump, volume control pump, variable volume control pump, peristaltic pump, lever-actuated pump, valve-actuated pump, or venturi pump. The fluid control unit 140 also includes three fluid reservoirs 144a, 144b, and 144c for storing various fluids 145a-c. Although FIG. 1A Three fluid reservoirs are shown, but more or fewer fluid reservoirs can be used. (Reference) FIG. 1A Each of the fluid reservoirs 144a-c is a syringe configured to be actuated by a syringe pump. In some embodiments, the multiple fluids 145a-c include a non-therapeutic solution 145a, a therapeutic solution 145b, and a working fluid 145c.

[0045] In operation, fluid pump 142 is configured to drive each of a plurality of fluids 145a-c to flow from fluid reservoirs 144a-c into cavities 128a-c of the multi-cavity tube 120 respectively. FIG. 1C As further described below, when the injection needle 110 is first inserted into the retina 20, the initial working fluid 145c is configured to flow through port 118c of connector 116. FIG. 1D This allows the stabilizer 130 to extend and the injection needle 110 to be stabilized. Then, the non-treatment solution 145a and the treatment solution 145b are configured to flow through ports 118a and 118b of the connector 116, respectively. FIG. 1D ), so that each of fluids 145a and 145b can be injected individually into the subretinal cavity 50 ( FIG. 1B (in) It should be noted that FIG. 1A The stabilizer 130 is shown in its extended position. About FIG. 1D Additional details regarding the operation of the stabilizer 130 are provided.

[0046] In some embodiments, the non-therapeutic solution 145a comprises an ophthalmic irrigation solution (e.g., BSS) having a physiological pH and osmotic pressure. In some embodiments, the therapeutic solution 145b comprises a therapeutic substance for treating the eye 10 (e.g., anti-VEGF, tissue plasminogen activator (tPA), stem cells, viral vectors for gene therapy, other drugs, or combinations thereof). In some embodiments, the working fluid 145c comprises a fluid for extending the stabilizer 130 (e.g., perfluorocarbon liquid (PFCL), BSS, saline, air, N2, other liquids or gases, or combinations thereof).

[0047] The fluid control unit 140 includes a controller 146 for controlling the operation of the fluid pump 142. In some embodiments, the controller 146 includes a wireless receiver 147a having an antenna 147b for wirelessly receiving commands from a console. The fluid control unit 140 includes a power source 148 for providing power to the fluid pump 142 and the controller 146. In some embodiments, the power source 148 includes at least one of a battery, one or more springs, or a gas container. In some other embodiments, power is provided by at least one of gravity or manual actuation. In some other embodiments, the fluid control unit 140 also includes a plurality of valves for regulating the flow of fluid from fluid reservoirs 144a-c.

[0048] FIG. 1D yes FIG. 1A Top isometric view of a portion of the injection device 100. (Reference) FIG. 1DThe connector 116 has three ports 118a, 118b, and 118c, each corresponding to a distal end of a lumen 128a-c of the multi-lumen tube 120, and disposed within these distal ends. Two separate ports 118a and 118b of the connector 116 merge together toward the distal end 114 of the injection needle 110. Port 118c, on the other hand, is separate from and fluidly isolated from each of ports 118a and 118b. Port 118c is fluidly coupled to the stabilizer 130, as shown.

[0049] refer to FIG. 1A and FIG. 1D Stabilizer 130 is shown in an extended or activated position, in which it extends from port 118c of connector 116. In the extended position, stabilizer 130 stabilizes injection needle 110 and controls the injection position of non-therapeutic solution 145a to help facilitate the positioning of the bubbly site, as described below. FIG. 4 and FIGS. 9A-9C A more detailed description. In FIG. 1A and FIG. 1D In some embodiments, the stabilizer 130 is a balloon 132 or pouch having a pair of wings 132a, 132b. In some other embodiments, the balloon 132 may have any suitable shape, including but not limited to circular, oval, or polygonal shapes. The balloon 132 may be formed of plastic, metal, polymer, nitinol, or combinations thereof.

[0050] When the stabilizer 130 is in such a state FIG. 1A and FIG. 1D Before the extended position shown, the stabilizer 130 is positioned within port 118c of the connector 116, as... FIG. 2D As shown and described in detail below. In some embodiments, in order to actuate the stabilizer 130 to the extended position, working fluid 145c (e.g., PFCL) is supplied from the fluid control unit 140 (…). FIG. 1A The fluid reservoir 144c is injected through the lumen 128c to fill the balloon 132 with PFCL. In the extended position, the wings 132a, 132b of the balloon 132 extend substantially along an axis perpendicular to the central longitudinal axis 120x of the multi-lumen tube 120. In some embodiments, the balloon 132 has a flat profile in the extended position. For example, in some embodiments, the width of the balloon 132, measured parallel to the surface 22 of the retina 20, is greater than the height of the balloon 132, measured orthogonally to the surface 22 (e.g., at least twice, at least five times, or at least ten times the height). Advantageously, the flat profile increases the contact surface area between the balloon 132 and the surface 22. In some embodiments, the balloon 132 is held in place primarily by the weight of the working fluid 145c within the balloon 132. It should be noted that FIG. 1A andFIG. 1D Only one example of a stabilizer is shown. About FIGS. 15-17 Additional examples of different operations are further described.

[0051] In the extended position, stabilizer 130 is configured to hold the injection needle 110 at a target location on the surface 22 of the retina 20, reducing the likelihood of the injection needle 110 being removed from the subretinal space 50 by minor unintentional force during treatment. As used herein, holding the injection needle 110 in place generally means restricting the movement of the injection needle 110 relative to the retina 20 in order to maintain the injection needle 110 at the target location on the surface 22 of the retina 20 throughout the treatment. That is, holding the injection needle 110 in place does not mean restricting the injection needle 110 to zero movement or no movement. Instead, the injection needle 110 should retain a certain degree of freedom while being held in the target location, allowing minor and / or unintentional forces to be applied safely without tearing the retina 20. Furthermore, the injection needle 110 should still be removable from the retina 20 even in the extended position if sufficient force is applied to it. Allowing the injection needle 110 to be removed in response to a sufficiently large pulling force prevents injury to the eye 10 or serious tearing. Additional details about stabilizer 130 and its operation are provided in Figures 5 through 12.

[0052] FIG. 2A This is a schematic diagram of an exemplary inserter device 250 that can be used with the injection device 100 described herein. Generally, the inserter device 250 is configured to be releasably coupled to an injection needle 110 to provide a rigid structure for inserting the injection needle 110 into the eye 10 and further into the subretinal cavity 50. The inserter device 250 includes a cannula 254, which is the portion of the inserter device 250 that directly engages with the injection needle 110 and is insertable into the eye 10. The cannula 254 has an aperture for surrounding a multi-lumen tube 120. FIG. 2A In one embodiment, the cannula 254 has a sealing hole extending longitudinally from its proximal end 254a to its distal end 254b.

[0053] The cannula 254 extends from the body 256, which is the portion of the inserter device 250 configured to be grasped and manipulated by a surgeon or surgical assistant. The body 256 has a needle release knob 258 for releasing the needle 110 from the cannula 254 when the needle 110 is properly positioned and secured within the eye 10. It is contemplated that the release knob 258 can function in a variety of different ways. For example, the release knob 258 may be a slider that moves a release mechanism to disengage the cannula 254 from the connector 116, thereby allowing the cannula 254 to retract away from the needle 110. In some embodiments, the release mechanism includes a pair of inner and outer tubes enclosing the connector 116, the inner and outer tubes having corresponding openings such that rotating the inner tube to align with the opening releases the needle 110. In some other embodiments, the release mechanism includes a tapered tube that moves within a ring surrounding and holding the connector 116, such that inserting the tapered tube widens the inner diameter of the ring to release the injection needle 110. In some other embodiments, the release mechanism includes two half-shells that enclose the connector 116 and are held together by a ring, such that moving the ring releases the injection needle 110. Alternatively, the cannula 254 may be spring-loaded, such that pressing the release knob 258 causes the cannula 254 to retract away from the injection needle 110. Alternatively, using a U-shaped cannula 264 (described in more detail below), the release knob 258 can push the cannula 264 to one side, thereby disengaging the cannula 264 from the connector 116 through a slit 265 formed along the length of the cannula 264. FIG. 2A In this embodiment, the inserter device 250 is configured to remain connected to the multi-lumen cannula 120 outside the eye 10, i.e., because the sealing orifice prevents the cannula 254 from being removed from around the multi-lumen cannula 120. It should be noted that... FIG. 2A Only one example of an inserter device is shown. Regarding FIG. 2B Additional examples of different operations are further described.

[0054] FIG. 2B This is a schematic diagram of another exemplary inserter device 260, which can be used with the injection device 100 described herein. Reference FIG. 2B The inserter device 260 is similar to FIG. 2AThe inserter device 264 is constructed and arranged as described herein, unless otherwise stated, and its corresponding description may be incorporated herein without limitation. In one or more embodiments, the cannula 264 has a slit 265 extending longitudinally from its proximal end 264a to its distal end 264b. In some embodiments, the cannula 264 has a U-shaped cross-section. In some embodiments, the slit 265 has a minimum width greater than the outer diameter of the multi-lumen tube 120. In this embodiment, the inserter device 260 is configured to be separated from the multi-lumen tube 120 outside the eye 10 by sliding the multi-lumen tube 120 through the slit 265.

[0055] FIG. 2C yes FIG. 1A A schematic diagram of an injection device 100 shows an exemplary inserter device 250 combined with the injection device. FIG. 2D yes FIG. 2C A partial enlarged side cross-sectional view shows an exemplary injection needle 110 used in conjunction with the injection device 100 described herein. Therefore, for clarity, it is described together herein... FIGS. 2C-2D The injection device 100 is shown in a configuration ready to begin a subretinal injection procedure. For example, an inserter device 250 is coupled to an injection needle 110, and the cannula 254 of the inserter device 250 surrounds the multi-lumen cannula 120. Furthermore, the stabilizer 130 is in a retracted position located within a port 118c of the connector 116, which is located within the distal end 254a of the cannula 254. FIG. 2D A straight injection needle 110 is shown. In other words, the injection needle 110 extends from its proximal end 112 to its distal end 114 at a constant angle substantially parallel to the central longitudinal axis 120x of the multi-lumen cannula 120. In some embodiments, such as FIG. 2D As shown, the cannula 254 of the inserter device 250 extends beyond the distal end 122 of the multi-lumen cannula 120 and surrounds the connector 116 of the injection needle 110. FIG. 2D In some embodiments, the cannula 254 has an inner diameter corresponding to the outer diameter of the connector 116.

[0056] FIG. 3 This is an isometric view of an exemplary injection device 300 for performing subretinal injections. (Reference) FIG. 3 The injection device 300 is used in conjunction with a surgical microscope 302 and an operating table 304. FIG. 3 In some of the optional embodiments shown, the fluid control unit 140 is attached to the surgical microscope 302. FIG. 3In some other optional embodiments shown, the fluid control unit 140 is attached to and / or rests on the forehead 62 of a patient 60 lying on the operating table 304. As described below, there are alternatives to positioning the fluid control unit 140 on the surgical microscope 302 or as... FIG. 3 Several advantages associated with the forehead 62 shown.

[0057] The first advantage is that attaching the fluid control unit 140 to a fixed object reduces the likelihood of applying external forces to the multi-lumen tube 120, which reduces the possibility of the injection needle 110 dislodging from or tearing the retina 20. In other words, attaching the fluid control unit 140 to a fixed object helps to separate the fluid control unit 140 from the moving object, which reduces the impact of external forces.

[0058] Another advantage is that by positioning the fluid control unit 140 close to the eye 10 (e.g., on the surgical microscope 302 or forehead 62), the overall relative length of the multi-lumen tube 120 is reduced compared to some other embodiments in which the fluid control unit 140 is positioned at a greater distance from the eye 10. This, in turn, reduces the dead volume of each of the various fluids 145a-c in the multi-lumen tube 120 between the fluid reservoirs 144a-c and the eye 10. Since therapeutic fluids are typically expensive, reducing fluid waste due to, for example, dead volume in the multi-lumen tube 120 can result in significant cost savings. It is also envisioned that reducing the distance between the fluid control unit 140 and the eye 10 reduces the system's resilience, thereby providing more precise fluid control.

[0059] In some other embodiments, the dead volume in the multi-lumen tube 120 can be reduced by using a microlumen tube with a reduced outer diameter and a reduced cross-sectional flow area compared to a standard tube. For example, it is envisioned that the microlumen tube may have an outer diameter of about 0.3 mm or less, while the standard tube has an outer diameter of about 0.4 mm.

[0060] In some other embodiments, the dead volume in the multi-lumen tube 120 can be reduced by preloading each of the multiple fluids 145a-c into the multi-lumen tube 120. In this embodiment, the injection needle 110 is configured to enter from the distal end 122 of the multi-lumen tube 120. FIG. 2DThe removal of fluids 145a-c allows each of these fluids to be directly loaded into the distal end 122 of one of the lumens 128a-c. In other words, the fluids 145a-c are stored within a portion of the multi-lumen tube 120, rather than within fluid reservoirs 144a-c. In this embodiment, the dead volume in the multi-lumen tube 120 upstream of the fluids 145a-c (i.e., between the fluid reservoirs 144a-c and the fluids 145a-c) can be filled with a relatively low-cost expulsion fluid (e.g., air, N2, BSS, brine, other liquids or gases, or combinations thereof). In this embodiment, the expulsion fluid is pressurized by a fluid pump 142, which in turn pressurizes the fluids stored in the multi-lumen tube 120. In some embodiments, lumen 128b is preloaded with a relatively more expensive treatment solution 145b, while lumens 128a and 128c receive a non-treatment solution 145a and a working fluid 145c from fluid reservoirs 144a and 144c, respectively.

[0061] FIG. 4 This is a figure illustrating a method 400 for subretinal injection using the injection device 100 described herein. In preparation for subretinal injection, the sclera 12 is incised using a cannula, which consists of a valved cannula 152. FIG. 5A The device consists of a pre-packaged cannula with a needle hub at the proximal end and a trocar. Typically, the cannula is inserted into the eye 10 until the bottom surface of the needle hub contacts the sclera 12. The cannula is then removed from the eye 10, leaving the valved cannula 152 in place, such as... FIGS. 5A-12A As shown. Although in FIGS. 5A-5B Not shown, but the bottom surface of the needle seat of the valved cannula 152 can be parallel or flush with the surface of the eye 10. At operation 402, the cannula 254 of the inserter device 250 is inserted into the eye 10 through the valved cannula 152. FIGS. 6A-6B ).

[0062] At operation 404, the distal end 114 of the injection needle 110 is inserted into the subretinal cavity 50 at the target location on the surface 22 of the retina 20. FIGS. 13A-13BIn some embodiments, the depth of the injection needle 110 is visually controlled. For example, in some embodiments, optical coherence tomography (OCT) imaging data can be used during surgery to provide visual confirmation that the distal end 114 of the injection needle 110 is positioned within the appropriate layer of the eye 10 (i.e., in the subretinal cavity 50). In some embodiments, the connector 116 acts as an end stop to prevent the injection needle 110 from being inserted too far into the eye 10 (e.g., through the RPE 30 or Bruch's membrane 40), which could potentially damage the eye 10. In some embodiments, the length of the injection needle 110, measured from the connector 116 to its distal end 114, is selected such that when the connector 116 contacts the surface 22 of the retina 20, the distal end 114 is correctly positioned between the retina 20 and the RPE 30. In some embodiments, the length of the injection needle 110 can be selected based on a preoperative determination of the thickness of the retina 20.

[0063] exist FIGS. 14A-14B In some other embodiments shown, the depth of the injection needle 1310 is controlled by using an end stop 1300. FIGS. 7A-7C In some other embodiments shown, the depth of the injection needle 1410 is controlled by using a curved injection needle 1410. Additional details about these embodiments are provided below.

[0064] At operation 406, stabilizer 130 is used to fix the injection needle 110 at the target location on the surface 22 of the retina 20. FIGS. 8A-8B In some of the illustrated embodiments, pressure or fluid is applied through the lumen 128c of the multi-lumen tube 120 to extend the stabilizer 130 beyond the distal end 122 of the lumen 128c, thereby positioning the stabilizer 130 in contact with the surface 22 of the retina 20. The stabilizer 130 is configured to securely contact the retina 20 in such a way that the injection needle 110 is fixed at a target location on the surface 22 of the retina 20. In some embodiments, the stabilizer 130 is formed of a material that conforms to the surface 22 of the retina 20 to increase the contact area between the two.

[0065] At operation 408, after the stabilizer 130 contacts the surface 22 of the retina 20, the cannula 254 of the inserter device 250 is retracted from the eye 10. FIGS. 8A-8BAfter the cannula 254 is retracted, the injection needle 110 and the multi-lumen cannula 120 are separated from the external force. As used herein, the external force generally includes any force applied from outside the eye 10 to the injection needle 110 or the multi-lumen cannula 120. For example, the external force generally includes slight and / or unintentional movement of any part of the injection device 100 by a surgeon or surgical assistant. In some embodiments, the separation limits the effect of the external force associated with the injection of non-therapeutic solution 145a (operation 410) or the injection of therapeutic solution 145b (operation 412). In some other embodiments, as previously described, where a handheld injection device is used for manually controlled injection in a two-step process, the separation limits the effect of the external force associated with movement of the handheld device.

[0066] exist FIG. 2B In some of the embodiments shown, an excessively long multi-lumen tube 120 in an unconstrained state is provided inside the eye 10 to facilitate separation. It will be understood that when an external force is applied to the multi-lumen tube 120, the excessive length allows the multi-lumen tube 120 to move inside the eye 10 without transmitting force to the injection needle 110. In use FIGS. 9A-9C In some embodiments of the inserter device 260, the inserter device 260 is separated from the multi-lumen tube 120 after retraction by sliding the multi-lumen tube 120 through the slit 265.

[0067] At operation 410, a non-therapeutic solution 145a is injected from the fluid control unit 140 into the subretinal space 50 via the lumen 128a of the multi-lumen tube 120. FIG. 9C In some embodiments, for example, a fluid pump 142 drives a non-therapeutic solution 145a through a lumen 128a to inject the non-therapeutic solution 145a from a fluid reservoir 144a into the subretinal cavity 50. In some embodiments, the injection of the non-therapeutic solution 145a causes a vacuole to form in the subretinal cavity 50 between the retina 20 and the RPE 30. FIGS. 10A-10B In some embodiments, the vacuoles are localized hemispherical elevations of the retina 20, which are visible under a surgical microscope. Thus, the formation of vacuoles by the non-therapeutic solution 145a provides visual confirmation that the distal end 114 of the injection needle 110 is positioned within the appropriate layer of the eye 10 (i.e., in the subretinal cavity 50).

[0068] At operation 412, treatment solution 145b is injected from fluid control unit 140 into subretinal space 50 via lumen 128b of multi-lumen tube 120. FIGS. 12A-12BIn some embodiments, fluid pump 142 drives therapeutic solution 145b through lumen 128b to inject therapeutic solution 145b from fluid reservoir 144b into subretinal space 50. In some embodiments, each of non-therapeutic solution 145a and therapeutic solution 145b is injected hands-free. In some embodiments, fluid pump 142 drives the flow of each of non-therapeutic solution 145a, therapeutic solution 145b, and working fluid 145c without manual actuation of multiple fluid reservoirs 144a-c. In some embodiments, fluid pump 142 operates according to instructions received from controller 146. In some embodiments, controller 146 receives control signals via wireless receiver 147a. In some embodiments, a surgeon or surgical assistant may use a foot pedal to control the injection pressure or volume of each of the multiple fluids 145a-c, the foot pedal being wirelessly communicated with controller 146 via wireless receiver 147a and antenna 147b.

[0069] At operation 414, the injection needle 110 is repositioned by retracting the stabilizer 130 into the distal end 122 of the lumen 128c. This removes contact between the stabilizer 130 and the surface 22 of the retina 20. In some embodiments, working fluid 145c is removed from the lumen 128c using vacuum pressure to retract the stabilizer 130 into the lumen. In some embodiments, contact between the stabilizer 130 and the surface 22 of the retina 20 is removed without retracting it into the distal end 122 of the lumen 128c.

[0070] At operation 416, the multi-lumen cannula 120 and the injection needle 110 connected to the multi-lumen cannula are removed from the eye 10. FIG. 13A With the stabilizer 130 not in contact with the retina 20, the injection needle 110 can be removed from the subretinal cavity 50 by applying slight tension to the multi-lumen cannula 120. In some embodiments, the retinal opening formed by inserting the injection needle 110 through the retina 20 can be relatively small compared to a typical surgery due to the various benefits of the devices and methods disclosed herein. In this embodiment, the retinal opening can remain untouched without sutures. In some other embodiments, the retinal opening can be filled with a sealant (e.g., fibrin glue, collagen, cyanoacrylate, cell adhesion factor, fibronectin, laminin, extracellular matrix-based hydrogel, polyacrylic acid, zinc polycarboxylate adhesive, silicone adhesive, or ophthalmic adhesive surgical device (OVD) or viscoelastic insert). In some other embodiments, the viscosity of the treatment solution 145b is sufficient to seal the retinal opening.

[0071] Various alternative embodiments are described in detail below. It will be understood that the following embodiments can be combined with injection device 100 and method 400 without limitation. FIG. 13AThis is an isometric view of another exemplary injection needle 1310, which can be used with the injection device 100 described herein. Reference FIG. 13A An end stop 1300 is disposed around the injection needle 1310 between the proximal end 1312 and the distal end 1314. FIG. 13B In some embodiments, the end stop 1300 is an annular disc with a central hole 1302 for receiving an injection needle 1310 passing through it. The end stop 1300 has a first face 1304 and a second face 1306 facing opposite directions parallel to the longitudinal axis of the central hole 1302. In some other embodiments, the end stop 1300 may have a non-circular profile (e.g., a polygonal or oval profile). In some embodiments, the end stop 1300 has an inner diameter corresponding to the outer diameter of the injection needle 1310 to form an interference fit between them. In some other embodiments, the end stop 1300 may be integral with the injection needle 1310 or attached to the injection needle 1310 by adhesive or fasteners.

[0072] FIG. 13A yes FIG. 14A A side cross-sectional view of the injection needle 1310 shows the injection needle 1310 inserted into the subretinal cavity 50. When the distal end 1314 of the injection needle 1310 is inserted into the subretinal cavity 50, the second surface 1306 contacts the surface 22 of the retina 20. The distance between the distal end 1314 and the second surface 1306 is chosen such that when the second surface 1306 contacts the surface 22 of the retina 20, the distal end 1314 is correctly positioned between the retina 20 and the RPE 30. Therefore, the end stop 1300 prevents the injection needle 1310 from being inserted too far into the eye 10 (e.g., through the RPE 30 or Bruch's membrane 40), which could potentially damage the eye 10. In some other embodiments, the second surface 1306 is tapered to facilitate insertion of the end stop 1300 through the sclera.

[0073] FIG. 14A This is an isometric view of yet another exemplary injection needle 1410, which can be used with the injection device 100 described herein. Reference FIG. 14B The injection needle 1410 is curved. For example, in some embodiments, the injection needle 1410 has a first portion 1417 extending substantially parallel to the central longitudinal axis 120x of the multi-lumen tube 120 and a second portion 1418 extending at an angle α1 different from the first portion 1417. In some embodiments, the angle α1 of the second portion 1418 is about 45 degrees or less (e.g., about 30 degrees or less, or about 10 degrees to about 30 degrees).

[0074] FIG. 14A yes FIG. 14BA side cross-sectional view of the injection needle 1410, showing the injection needle 1410 inserted into the subretinal cavity 50. (Reference) FIG. 14B The angle α2 between the second portion 1418 of the injection needle 1410 and the surface 32 of the RPE 30 is smaller than the angle (α1+α2) between the first portion 1417 and the surface 32. Due to the angle α2 of the second portion 1418, the injection needle 1410 enters the subretinal cavity 50 at a shallower angle than the angle (α1+α2) between the first portion 1417 and the surface 32. For example, bending the injection needle 1410 ( FIG. 13B The lower entry angle α2 of the straight injection needle 1310 ( FIG. 15 The relatively high entry angle of the needle 1410 is compared. In essence, the curvature of the needle 1410 helps to properly position the distal end 1414 between the retina 20 and the RPE 30, thereby helping to prevent the needle 1410 from being inserted too far into the eye 10 (e.g., through the RPE 30 or the Bruch's membrane 40).

[0075] FIG. 15 This is a top-view isometric view of another exemplary stabilizer 1530, which can be used with the injection device 100 described herein. FIG. 15 In the embodiment, stabilizer 1530 is shown in the extended position. In the retracted position, stabilizer 1530 may be disposed within port 118c of connector 116 and / or within lumen 128c of multi-lumen tube 120. Reference FIG. 15 The stabilizer 1530 is a wire 1532 formed from a shape memory alloy or a highly elastic material (e.g., nitinol). The wire 1532 is connected to the connector 116 of the injection needle 110. FIG. 1A In some of the embodiments shown, the filament 1532 is formed as a pair of wings 1532a, 1532b. In some other embodiments, the filament 1532 may be formed in any suitable shape, including but not limited to circular, oval, or polygonal. In the retracted position, the filament 1532 is disposed within the port 118c of the connector 116 and / or within the lumen 128c, such that the wings 1532a, 1532b are folded substantially parallel to the central longitudinal axis 120x of the multi-lumen tube 120. In some embodiments, the working fluid 145c (e.g., PFCL) is diverted from the fluid control unit 140 (… FIG. 16A fluid reservoir 144c is injected through a lumen 128c to apply pressure and extend the filament 1532 from the lumen 128c. In the extended position, wings 1532a, 1532b may extend substantially along an axis perpendicular to the central longitudinal axis 120x of the multi-lumen tube 120. In some embodiments, the filament 1532 is held in place primarily by friction between the filament 1532 and the surface 22 of the retina 20. In some embodiments, in the extended position, the filament 1532 has a flat profile. For example, in some embodiments, the width of the filament 1532 measured parallel to the surface 22 of the retina 20 is greater than the height of the filament 1532 measured orthogonally to the surface 22 (e.g., at least twice, at least five times, or at least ten times the height).

[0076] FIG. 16 This is a top isometric view of yet another exemplary stabilizer 1630, which can be used with the injection device 100 described herein. FIG. 16 In one embodiment, stabilizer 1630 is shown in an extended position. In the retracted position, stabilizer 1630 may be disposed within port 118c of connector 116 and / or within lumen 128c of multi-lumen tube 120. It can be combined without limitation with other embodiments disclosed herein. FIG. 16 In some of the embodiments shown, the stabilizer 1630 includes a plurality of barbs 1634 disposed on the structure 1632 (e.g., a balloon, wire, plate, or a combination thereof). The structure 1632 is shown in dashed lines to more clearly show the barbs 1634 disposed on its underside. The barbs 1634 are configured to increase friction between the stabilizer 1630 and the surface 22 of the retina 20. In some other embodiments, in addition to or instead of the plurality of barbs 1634, other elements that induce friction may be incorporated into the structure 1632 (e.g., rough texture, teeth, bristles, or a combination thereof). FIG. 17 In some of the embodiments shown, structure 1632 includes a pair of wings 1632a, 1632b. In some other embodiments, structure 1632 may have any suitable shape, including but not limited to circular, oval, or polygonal shapes. In some embodiments, in the extended position, structure 1632 has a flat profile. For example, in some embodiments, the width of structure 1632, measured parallel to surface 22 of retina 20, is greater than the height of structure 1632, measured orthogonally to surface 22 (e.g., at least twice, at least five times, or at least ten times the height).

[0077] FIG. 17 This is a top-view isometric view of yet another exemplary stabilizer 1730, which can be used with the injection device 100 described herein. FIG. 17In the embodiment, stabilizer 1730 is shown in the extended position. In the retracted position, stabilizer 1730 may be disposed within port 118c of connector 116 and / or within lumen 128c of multi-lumen tube 120. Reference FIG. 17 The stabilizer 1730 includes a plate 1732 and an adhesive 1734. The plate 1732 may be formed of plastic, metal, polymer, nitinol, or a combination thereof. The adhesive 1734 may include an adhesive material based on at least one of fibrin, cyanoacrylate, gelatin, thrombin, polyethylene glycol, albumin, or glutaraldehyde. In some other embodiments, a non-adhesive material, such as a viscoelastic material, may be used for temporary physical bonding. In some other embodiments, the plate 1732 may have a contour that conforms to a surface 22 of the retina 20 and acts as a suction cup to hold the plate 1732 in place. In some other embodiments, a vacuum pressure (e.g., about 1 mmHg to about 650 mmHg) may be applied to the volume between the plate 1732 and the surface 22 of the retina 20.

[0078] In some embodiments, adhesive 1734 is pre-applied to plate 1732 (e.g., applied to the underside of the surface 22 of plate 1732 facing retina 20) when plate 1732 is folded inside connector 116. FIG. 18 In some of the illustrated embodiments, when the underside of the plate 1732 contacts the surface 22 of the retina 20, the adhesive 1734 is configured to at least slightly adhere the plate 1732 to the surface 22 of the retina 20. In some embodiments, the adhesive 1734 may increase friction between the plate 1732 and the surface 22 of the retina 20 without fixing these surfaces together. In some other embodiments, the adhesive 1734 is applied via a lumen 128c in conjunction with the extension of the plate 1732. FIG. 18 In some of the embodiments shown, plate 1732 includes a pair of wings 1732a, 1732b. In some other embodiments, plate 1732 may have any suitable shape, including but not limited to circular, oval, or polygonal shapes. In some embodiments, in the extended position, plate 1732 has a flat profile. For example, in some embodiments, the width of plate 1732 measured parallel to surface 22 of retina 20 is greater than the height of plate 1732 measured orthogonally to surface 22 (e.g., at least twice, at least five times, or at least ten times the height).

[0079] ​ This is a schematic diagram of an exemplary guidewire 1800, which can be used with the injection device 100 described herein. In some embodiments, the guidewire 1800 replaces the inserter device 250. The guidewire 1800 is disposed approximately parallel to the central longitudinal axis 120x along the outer wall 126o of the multi-lumen tube 120. ​In some of the illustrated embodiments, the guidewire 1800 extends to the distal end 122 of the multi-lumen cannula 120. In some embodiments, the guidewire 1800 extends at least partially along the length of the multi-lumen cannula 120, including a portion of the multi-lumen cannula 120 inserted into the eye 10. In some embodiments, the guidewire 1800 extends from the proximal end 124 of the multi-lumen cannula 120 to its distal end 122. The guidewire 1800 is more rigid than the multi-lumen cannula 120. The guidewire 1800 is configured to provide axial stiffness in the direction of the central longitudinal axis 120x to apply sufficient axial pressure to the injection needle 110 to insert the distal end 114 of the injection needle 110 into the subretinal cavity 50 at a target location on the surface 22 of the retina 20 without the use of the inserter device 250. The guidewire 1800 has a bending stiffness less than the axial stiffness to limit the transmission of unwanted bending forces from outside the eye 10 to the injection needle 110.

[0080] In some other embodiments that do not use the inserter device 250, other mechanisms may be used to provide variable stiffness to the multi-lumen cannula 120. In some embodiments, for example, the multi-lumen cannula 120 has higher stiffness during insertion of the distal end 114 of the injection needle 110 into the subretinal cavity 50 (operation 404), and lower stiffness after securing the injection needle 110 to a target location on the surface 22 of the retina 20 (operation 406) (e.g., during at least one of retraction of the cannula 254 (operation 408), injection of the non-therapeutic solution 145a (operation 410), or injection of the therapeutic solution 145b (operation 412) to disengage the injection needle 110 from external forces. In some embodiments, only the portion of the multi-lumen cannula 120 inserted into the eye 10 has variable stiffness. In some other embodiments, the entire length of the multi-lumen cannula 120 has variable stiffness.

[0081] In some other embodiments, applying a voltage to the multilumen tube 120 alters its stiffness. For example, at least a portion of the multilumen tube 120 may have lower stiffness when no voltage is applied, and higher stiffness when a voltage is applied. In such embodiments, at least a portion of the multilumen tube 120 may be formed of a material that undergoes a chemical or physical change induced by a voltage, thereby imparting greater stiffness to the multilumen tube 120.

[0082] In some other embodiments, applying pneumatic pressure to the multi-lumen tube 120 alters its stiffness. For example, at least a portion of the multi-lumen tube 120 may have lower stiffness without pneumatic pressure and higher stiffness with pneumatic pressure applied. In such embodiments, one or more lumens of the multi-lumen tube 120 may be filled with pneumatic pressure to increase stiffness.

[0083] In some other embodiments, the multi-lumen tube 120 may include multiple structural segments that impart greater stiffness when compressed and lower stiffness when tensioned. Thus, during insertion of the distal end 114 of the injection needle 110 into the subretinal cavity 50 (operation 404), the multi-lumen tube 120 can have relatively high stiffness when placed in a compressed state. After securing the injection needle 110 at a target location on the surface 22 of the retina 20 (operation 406), the multi-lumen tube 120 can be placed in a tensioned state to induce lower stiffness, thereby allowing the injection needle 110 to disengage from external forces.

[0084] In summary, the embodiments of this disclosure improve the efficacy and safety of subretinal injections for treating ophthalmic conditions. Specifically, the embodiments of this disclosure provide hands-free and precisely controlled fluid injection, ensuring correct injection volume and dosage, appropriate flow rate into the subretinal space without damaging the retina or RPE, and appropriate shear force in the needle to help maintain the bioactivity of various therapeutic agents carried by the injection fluid. Furthermore, the embodiments of this disclosure isolate the injection needle from external forces, thereby preventing unintentional movement of the injection needle that could lead to retinal tears. Additionally, the embodiments of this disclosure provide a two-step injection process—injecting a non-therapeutic solution and a therapeutic solution—without removing the injection needle from the subretinal space, thereby mitigating damage to the retina caused by re-entry of the injection needle.

[0085] While the embodiments described above relate to this disclosure, other and further embodiments of this disclosure may be devised without departing from its essential scope, the scope of which is defined by the following claims.

[0086] Exemplary embodiments

[0087] Example 1: The device of claim 1, wherein the injection needle and the multi-lumen cannula are configured to separate from external force after the injection needle has been fixed to the surface of the retina at that position.

[0088] Example 2: The device of claim 9, wherein the stabilizer comprises a nitinol wire, wherein the nitinol wire is extended by applying pressure or fluid thereto, and wherein, in the extended position, the nitinol wire has a first wing and a second wing extending substantially along an axis perpendicular to the longitudinal axis of the distal end of the multi-lumen tube.

[0089] Example 3: The device of claim 9, wherein the stabilizer includes barbs configured to increase friction between the stabilizer and the surface of the retina.

[0090] Example 4: The device of claim 9, wherein the stabilizer comprises an adhesive and a plate, wherein the adhesive is disposed on the surface of the plate, and wherein the adhesive is configured to increase friction between the two when the surface of the plate contacts the surface of the retina.

[0091] Example 5: The method of claim 15 further includes separating the inserter device from the multi-lumen tube after the retraction.

Claims

1. An apparatus for subretinal injection into the subretinal space between the retina and the retinal pigment epithelium of the eye, the apparatus comprising: An injection needle having a proximal end and a distal end, the distal end being configured to be inserted into the subretinal cavity at a location on the surface of the retina; A multi-lumen tube having a distal end connected to the proximal end of the injection needle and a proximal end connected to a fluid control unit, the multi-lumen tube having a first lumen and a second lumen; A stabilizer configured to fix the injection needle at the location on the surface of the retina; as well as The fluid control unit has a first fluid reservoir containing a non-therapeutic solution and a second fluid reservoir containing a therapeutic solution, wherein the fluid control unit is configured to inject the non-therapeutic solution from the first fluid reservoir into the subretinal cavity via the first lumen, and wherein the fluid control unit is configured to inject the therapeutic solution from the second fluid reservoir into the subretinal cavity via the second lumen. The stabilizer includes a balloon that extends by being filled with liquid, and wherein, in the extended position, the balloon has a first wing and a second wing extending substantially along an axis perpendicular to the longitudinal axis of the distal end of the multi-lumen tube. The balloon has a flattened profile, such that the width of the balloon, measured parallel to a surface of the retina, is at least twice the height of the balloon, measured perpendicular to a surface of the retina; and The multi-lumen tube further includes a third lumen, wherein the stabilizer is coupled to the distal end of the third lumen, and wherein fluid applied through the third lumen is configured to extend the stabilizer beyond the distal end of the third lumen, thereby placing the stabilizer on the surface of the retina.

2. The device as claimed in claim 1, wherein, The fluid control unit further includes a third fluid reservoir, and wherein the fluid control unit is configured to inject working fluid from the third fluid reservoir via the third lumen to extend the stabilizer.

3. The device of claim 1, further comprising an inserter device, wherein, The multi-lumen tube is disposed through the inserter device.

4. The device as described in claim 3, wherein, The inserter device includes a slit extending longitudinally from its proximal end to its distal end, and wherein the inserter device is configured to separate from the multi-lumen tube outside the eye by sliding the multi-lumen tube through the slit.

5. The device as described in claim 3, wherein, The inserter device includes a sealing aperture extending longitudinally from its proximal end to its distal end, and wherein the inserter device is configured to remain connected to the multi-lumen cannula outside the eye.

6. The device as claimed in claim 1, wherein, The fluid control unit further includes a pump configured to drive the flow of each of the non-therapeutic solution and the therapeutic solution, the pump being at least one of a syringe pump, a peristaltic pump, a venturi pump, a lever-actuated pump, a valve-actuated pump, or a combination thereof.

7. The device as claimed in claim 1, wherein, The fluid control unit can be attached to at least one of a surgical microscope or the patient's forehead.

Images