Device and method for accessing the posterior segment of the eye, with precise localization and needle penetration depth.

Abstract

a) Methods and devices for injecting / delivering fluid into and / or draining / removing fluid from the eye are described herein. One device may include a probe comprising: a body having a distal end; a needle extending and retracting from an exit position on the side of the distal end, the needle having a needle conduit; and one or more probe conduits for moving fluid through the probe, the one or more probe conduits being fluidically coupled to the needle conduit. During use, the side portion having the exit position is positioned adjacent to the surface of the eye, the needle is extended to penetrate into the eye, and the fluid is injected or drained through the needle conduit.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority from U.S. Provisional Patent Application No. 63 / 578,330, filed on 23 August 2023, and from U.S. Provisional Patent Application No. 63 / 624,372, filed on 24 January 2024. The entire contents of U.S. Provisional Patent Application No. 63 / 578,330 and U.S. Provisional Patent Application No. 63 / 624,372 are incorporated herein by reference in their entirety.

[0002] The various embodiments described herein generally relate to devices and methods for the delivery of substances (including drugs) to the posterior segment of the eye (suprachoroidal or subretinal space) via direct external scleral penetration with precise localization and precise needle penetration depth, such as minimally invasive suprachoroidal delivery of viscoelastic agents for the repair of retinal tears or rhegmatogenous retinal detachment. [Background technology]

[0003] Repair of rhegmatogenous retinal detachment (RRD) has advanced remarkably over the past century. Scleral buckles (SBs) have been used for decades. 1 Although it was once a primary technique, since the early 21st century, vitrectomy of the ciliary body (PPV) has become the preferred procedure for most surgeons. 2 However, the functional results after PPV were SB 3 and gas retinal reattachment surgery 4 It has been reported to be inferior to [another method]. Advances in multimodal imaging indicate a high risk of undesirable structural abnormalities after PPV. 5-8 Recent evidence suggests the need for additional treatment, such as draining subretinal fluid. 9 , heavy liquid 10 The use of large gas tamponades 11 However, it has been suggested that this can be harmful in some cases. This knowledge has led surgeons to modify their techniques not only to achieve reattachment in a single surgery, but also to maximize the integrity of the reattachment.

[0004] Some conventional techniques for the suprachoroidal delivery of viscoelastic agents for the repair of retinal tears or detachments have involved scleral incision (e.g., an incision into the sclera) with or without tissue dissection (manual separation of the choroid from the sclera) and direct injection of the viscoelastic agent, or involving incision followed by passage into the suprachoroidal space and through the suprachoroidal space, with the viscoelastic agent injected once the probe is positioned in the area of ​​the retinal tear. However, these are relatively invasive procedures (with a potentially greater risk of bleeding and other complications) and must be performed in an operating room, which increases the cost and delay until the operating room is available. Therefore, there is a need for minimally invasive techniques that do not necessarily need to be performed in an operating room, or, if performed in an operating room, can be performed without scleral incision.

[0005] Similarly, the delivery techniques for therapeutic drugs to the retina and other structures on the posterior side of the eye, including the subretinal space, are either invasive (such as involving eye incision and / or subretinal injection) or untargeted (such as involving intravitreal injection), resulting in risks of complications such as eye damage, vision loss, and / or dilution of therapeutic effect. Therefore, there is also a need for minimally invasive techniques for targeted delivery of therapeutic drugs to the posterior side of the eye via the suprachoroidal and / or subretinal spaces.

[0006] Overview of various embodiments In one embodiment, according to the teachings of this specification, at least one embodiment of a device for injecting fluid into or draining fluid from an eye is provided, wherein the device comprises a probe: a body having a distal end; a needle having a needle conduit, which extends and retracts from an outlet position on the side of the distal end; and one or more probe conduits for moving fluid through the probe, one or more probe conduits being fluidically coupled to the needle conduits; wherein, during use, the side portion having the outlet position is positioned adjacent to the surface of the eye, the needle extends to penetrate into the eye, and the fluid is injected or drained through the needle conduits.

[0007] In at least one embodiment, the needle is configured to exit the probe substantially perpendicular to the lateral tangent at the exit position.

[0008] In at least one embodiment, the side surface is concave and has a radius of curvature that substantially matches the radius of curvature of the sclera.

[0009] In at least one embodiment, the longitudinal axis of the distal end is at an angle to the longitudinal axis of the main body.

[0010] In at least one embodiment, the device includes a needle actuator coupled to a needle and controllable to extend and retract the needle.

[0011] In at least one embodiment, the device includes a fluid actuator coupled to a needle, which is controllable to move a fluid through a needle conduit between one or more probe conduits and an eye.

[0012] In at least one embodiment, a boss is provided on the side at an exit position, and the needle is configured to extend and retract through the boss, or a boss is provided on the side adjacent to the exit position, and the needle is configured to extend and retract adjacent to the boss.

[0013] In at least one embodiment, one or more probe conduits include an injection conduit and an outlet conduit, and the probe includes a coupling that can switch between a state in which the outlet conduit is fluidly coupled to the needle conduit and a state in which the injection conduit is fluidly coupled to the needle conduit.

[0014] In at least one embodiment, the device further includes a guide light source configured to generate a guide light beam for illumination or to indicate that the tip of the needle has penetrated different layers of the eye by a change in transmitted or reflected light.

[0015] In at least one embodiment, the device further comprises at least one guide tool configured to perform measurements for determining the location of the needle tip and / or a target injection or drainage site within the eye.

[0016] In at least one embodiment, the device further comprises a control unit, which is either contained within the probe or located separately from the probe, the control unit optionally comprising a display; a memory unit for storing software instructions for performing one or more functions; a device interface for receiving measurement data and transmitting control signals for operating the device; a speaker or vibrator (optional) for generating an audio signal or vibration corresponding to the operating parameters and / or measurement data of the device; a processor communicatively coupled to any of the memory unit, interface, speaker or vibrator, and display, the processor configured to perform one or more functions when executing software instructions, the one or more functions including receiving measurement data, transmitting control signals, generating an audio signal or vibration, and displaying at least a portion of the measurement data on the display; and a power supply for supplying power to the components of the device.

[0017] In at least one embodiment, the device comprises a pump fluidically coupled to one or more probe conduits, which is controllable to generate an injection pressure when the fluid is injected into the eye and an exhaust pressure when the fluid is discharged from the eye.

[0018] In at least one embodiment, the probe further comprises a flange and / or a variable coupler at the exit position, thereby maintaining position or pressure between the side and the eye surface.

[0019] In at least one embodiment, the flange and / or the variable coupler further comprises one or more sensors for measuring the positional relationship and / or pressure at one or more points between the side surface of the distal end of the probe and the surface of the eye.

[0020] In at least one embodiment, the device further comprises an infusion fluid container and / or a drainage fluid container connected to one or more probe conduits.

[0021] In at least one embodiment, the needle is configured to extend to a depth inside the suprachoroidal space, subretinal space, or vitreous cavity of the eye.

[0022] In at least one embodiment, the eye has rhegmatogenous retinal detachment (RRD) or a retinal tear, and the device is configured to inject fluid into the suprachoroidal space of the eye to form a choroidal buckle for treating RRD or retinal tear.

[0023] In at least one embodiment, the fluid comprises a treatment fluid including any combination of drugs, gene therapy, sustained-release implants, viscoelastic substances, hydrogels, and gases.

[0024] In another aspect, in accordance with the teachings of the present specification, there is provided a method for injecting fluid into or draining fluid from an eye, the method comprising: positioning the side surface of the distal end of a probe comprising a needle having a needle conduit, with the needle in a retracted state, adjacent to the surface of the eye; extending the needle from an exit position on the side surface of the distal end of the probe to penetrate into the eye; and injecting or draining fluid between the probe and the eye through the needle conduit.

[0025] In at least one embodiment, the method comprises extending the needle in a direction that is substantially perpendicular to a tangent to the side surface of the probe at the exit position.

[0026] In at least one embodiment, a side surface of the distal end portion of the probe is concave and has a radius of curvature that substantially matches the radius of curvature of the sclera.

[0027] In at least one embodiment, the longitudinal axis of the distal end portion is angled relative to the longitudinal axis of the main body.

[0028] In at least one embodiment, the method comprises using a needle actuator for controlling extension and retraction of a needle.

[0029] In at least one embodiment, the method comprises using a fluid actuator for controlling fluid injection and discharge.

[0030] In at least one embodiment, the method comprises using measurements taken by a guide light beam and / or a guide tool to determine the position of a needle tip and / or a target injection or discharge site in the eye.

[0031] In at least one embodiment, a control unit that is integral with the probe or separate from the probe is used for displaying measurement data from the probe, transmitting control signals to the probe, and / or generating an audio signal or vibration corresponding to operating parameters of the device and / or the measurement data.

[0032] In at least one embodiment, the method comprises extending a needle into the suprachoroidal space, subretinal space, or intravitreal cavity of the eye.

[0033] In at least one embodiment, the method comprises using a fluid that includes a treatment fluid including any combination of drugs, gene therapy, sustained-release implants, viscoelastic substances, hydrogels, and gases.

[0034] In at least one embodiment, the eye has a rhegmatogenous retinal detachment (RRD) or a retinal tear, and the method comprises injecting a fluid into the suprachoroidal space (SCS) of the eye to create a choroidal buckle for treating the RRD or retinal tear.

[0035] It will be understood that the above summary presents representative aspects of the embodiments to assist experienced readers in understanding the following detailed description. Other features and advantages of this application will become apparent from the following detailed description, which will be read in conjunction with the accompanying drawings. However, it should be understood that the detailed description and specific examples, while illustrating preferred embodiments of this application, are given merely as examples, for various changes and modifications within the spirit and scope of this application will become apparent to those skilled in the art from this detailed description.

[0036] To better understand the various embodiments described herein and to more clearly illustrate how these embodiments may be carried out, we refer to the accompanying drawings, which illustrate at least one embodiment as an example, and these drawings are described below. The drawings are not intended to limit the scope of the teachings described herein. [Brief explanation of the drawing]

[0037] [Figure 1] This figure shows an exemplary embodiment of an ophthalmic treatment device for precise localization and precise needle depth penetration, for ophthalmic procedures such as treating retinal tears or rhegmatogenous retinal detachment (RRD), or for delivering drugs, other therapeutic agents, or other treatment fluids, as taught herein. [Figure 2A] This figure shows an exemplary embodiment of an alternative probe that may be used with an ophthalmic treatment device for precise localization and precise needle depth penetration, for example, in ophthalmic procedures such as treating retinal tears or rhegmatogenous retinal detachment (RRD), or for delivering drugs, other therapeutic agents, or other treatment fluids, as taught herein. [Figure 2B]This figure shows an exemplary embodiment of a control unit used with an ophthalmic treatment device in accordance with the teachings of this specification. [Figure 2C] Figure 2B is a block diagram of an exemplary embodiment of various components of the control unit. [Figure 3A] Multiple embodiments of the distal end of a probe having different curvatures and lengths are shown for localization at different eye positions. [Figure 3B] Figure 3A shows a magnified view of one of the distal ends of the probe. [Figure 3C-3D] This shows examples of probe distal end placement at different eye locations, involving needle penetration and fluid injection at different depths. [Figure 3E] Some exemplary embodiments of ophthalmic treatment devices equipped with pressure distribution flanges are shown. [Figure 3F] Some exemplary embodiments of an ophthalmic treatment device equipped with a pressure distribution flange and a variable coupler are shown. [Figure 3G] A front view of an exemplary embodiment of a pressure distribution flange equipped with one or more sensors is shown. [Figure 3H] This document presents exemplary embodiments of alternative probes that can be used with ophthalmic treatment devices for precise localization and accurate needle depth penetration in ophthalmic procedures where the probe is a standalone device. [Figure 4A] This is a flowchart of an exemplary embodiment of a method for treating a retinal tear or RRD, as taught herein. [Figure 4B] This is a flowchart of another exemplary embodiment of a method for treating a retinal tear or RRD, as taught herein. [Figure 4C-4N] Images of different stages of methods for repairing retinal tears or RRDs are shown. [Figure 4O] A flowchart illustrating an exemplary embodiment of a method for precise localization and depth penetration on the surface of the eye for ophthalmic procedures is shown. [Figures 5A-5C] This image shows time-lapse ultrawide-angle photographs of a patient with pseudophakic eye presenting with RRD in the right eye. [Figure 6]The final appearance of the choroidal elevation formed after the suprachorionic treatment (ST) procedure as taught herein is shown. [Figures 7A-7B] These are longitudinal and vertical sweep optical coherence tomography (SS-OCT) scans acquired at the ST injection site after the ST procedure, taken on postoperative day 1 and postoperative day 5, respectively. [Figures 8A-8D] The baseline longitudinal SS-OCT scan after ST procedure, the SS-OCT scan on postoperative day 1, the SS-OCT scan on postoperative day 2, and the SS-OCT scan on postoperative day 3 are shown, respectively. [Figure 9] This image shows the fundus autofluorescence image on postoperative day 5 after the ST procedure. [Figure 10A-10C] The images show longitudinal SS-OCT scans of the temporal macula and temporal midperiphery, indicating the location where the ST procedure was performed (left side of the image). These scans were acquired on postoperative days 1, 3, and 5, respectively, after the ST procedure. [Figures 11A-11B] These are OCT scan images after ST procedure, showing a low-reflection space between the choroid and sclera (arrowhead) and mild residual inferior subretinal fluid without outer retinal folds in the lowest peripheral area (star).

[0038] Further aspects and features of the exemplary embodiments described herein will become apparent from the following description, which should be read in conjunction with the accompanying drawings. [Modes for carrying out the invention]

[0039] Various embodiments of the teachings herein are described below to provide examples of at least one embodiment of the claimed subject matter. No embodiment described herein limits the claimed subject matter. The claimed subject matter is not limited to a device, system, or method having all the features of any one of the devices, systems, or methods described below, nor is it limited to features common to some or all of the devices, systems, or methods described herein. There may be devices, systems, or methods described herein that are not any embodiment of the claimed subject matter. Any subject matter described herein but not claimed herein may be subject to other means of protection, such as a continuing patent application, and the applicant, inventor, or right holder does not intend to waive, abandon, or dedicate to the public such subject matter by the disclosure herein.

[0040] Furthermore, for the sake of conciseness and clarity of the illustrations, it is understood that reference numbers are repeated between drawings to indicate corresponding or similar elements or processes, where deemed appropriate. In addition, numerous specific details are provided to allow for a full understanding of the embodiments described herein. However, it will be understood by those skilled in the art that the embodiments described herein can be carried out without these specific details. In other cases, well-known methods, procedures, and components are not described in detail so as not to obscure the embodiments described herein. Furthermore, this description should not be considered to limit the scope of the embodiments described herein.

[0041] Furthermore, it should be noted that the terms “coupled” or “coupling” as used herein may have several different meanings depending on the context in which they are used. For example, the terms “coupled” or “coupling” may have mechanical, electrical, or communication implications. For instance, as used herein, the terms “coupled” or “coupling” may, depending on the specific context, indicate that two elements or devices can be directly connected to each other, or that they can be connected to each other through one or more intermediate elements or devices via electrical elements, electrical signals, optical signals, or mechanical elements.

[0042] Similarly, throughout this specification and the appended claims, the term “communication” is used in variations such as “communication path,” “communication coupling,” and “communicationally coupled,” and is generally used to refer to any engineering configuration for transferring and / or exchanging information. Examples of communication paths include, but are not limited to, conductive paths (e.g., conductive wires, physiological signal conduction), electromagnetic radiation paths (e.g., radio waves, optical signals, etc.), or any combination thereof. Examples of communication coupling include, but are not limited to, electrical coupling, magnetic coupling, radio coupling, optical coupling, or any combination thereof.

[0043] Unless otherwise required by context, the word “comprise” and its variations (e.g., “comprises” and “comprising”) throughout this specification and the subsequent claims should be interpreted in an open, inclusive sense, that is, “including, but not limited to.”

[0044] Furthermore, it should be noted that, as used herein, the phrase "and / or" is intended to represent an inclusive OR. That is, for example, "X and / or Y" is intended to mean either X, Y, or both X and Y. As further examples, the phrases "X, Y, and / or Z," "any combination of X, Y, and Z," or "X, Y, Z or any combination thereof" are intended to mean X, Y, Z, X and Y, X and Z, Y and Z, or X, Y, and Z.

[0045] It should be noted that the terms of degree used herein, such as “substantially,” “about,” and “approximately,” mean a reasonable deviation of the word being modified, provided that the final result does not change significantly. These terms of degree may also be interpreted as including deviations of the word being modified, for example, 1%, 2%, 5%, 10%, or 15%, provided that the deviation does not impair the meaning of the word it modifies.

[0046] Furthermore, in this specification, any numerical range indicated by an endpoint includes all numbers and fractions within that range (for example, 1–5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It should also be noted that all numbers and fractions are presumed to be modified by the term “approximately,” meaning a variation of a certain amount of the referenced number (e.g., 1%, 2%, 5%, 10%, or 15%) without significantly altering the final result.

[0047] Some exemplary embodiments of systems, devices, or methods described herein may be implemented as a combination of hardware and / or software. For example, some embodiments described herein may be implemented, at least in part, by using one or more computer programs running on one or more programmable devices having at least one processing element and at least one data storage element (including volatile and / or non-volatile memory). These devices may also have, depending on the nature of the devices, at least one input device (e.g., a keyboard, mouse, touchscreen, button, switch, dial, slider, etc.) and at least one output device (e.g., a display screen, printer, wireless communication device, speaker, vibrator, etc.).

[0048] It should also be noted that elements may exist that are used to implement at least some of the embodiments described herein, and these elements may be implemented by software written in a high-level procedural language, such as object-oriented programming. The program code may be written in C, C++ or other suitable programming language, and may include modules or classes, as is known to those skilled in the art of object-oriented programming. Alternatively, or in addition, some of these elements implemented by software may be written in assembly language, machine code or firmware, as may be required.

[0049] At least a portion of a software program used to implement at least one of the embodiments described herein may be stored on a storage medium or device readable by a general-purpose or dedicated programmable device. When read by the programmable device, the software program code configures the programmable device to operate in a new, specific, and predefined manner to perform at least one of the methods described herein.

[0050] Furthermore, at least a portion of the programs relating to the systems and methods of the embodiments described herein may be distributed as a computer program product comprising a computer-readable medium carrying computer-usable instructions (e.g., program code) for one or more processors. The program code may be pre-installed and embedded at the time of manufacture and / or installed later as an update for an already deployed computing system. The medium may be provided in a variety of forms, including, but not limited to, one or more diskettes, compact disks, tapes, chips, and non-transient forms such as magnetic storage and electronic storage. In alternative embodiments, the medium may be inherently temporary, including, but not limited to, wired transmission, satellite transmission, internet transmission (e.g., download), media, digital signals, and analog signals. The computer-usable instructions may also be in a variety of forms, including compiled code and uncompiled code.

[0051] Any module, unit, component, server, computer, terminal, or device described herein and performing software instructions in accordance with the teaching herein includes, or may be accessible from, computer-readable media such as storage media, computer storage media, or data storage devices (removable and / or non-removable). These media include, for example, magnetic disks, optical disks, or tapes. Computer storage media may include volatile or non-volatile, removable or non-removable media implemented in any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Examples of computer storage media include RAM, ROM, EEPROM, flash memory or other memory technologies, CD-ROM, digital versatile disk (DVD) or other optical storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, or any other media that can be used to store desired information and may be accessed by an application, module, or both. Any such computer storage media may be part of a device, accessible from that device, or connectable to that device.

[0052] This specification describes various exemplary embodiments of methods and ophthalmic treatment devices that may be used to access parts of the eye, such as the suprachoroidal and subretinal spaces, which are intended for access from the external sclera with precise localization and accurate needle-depth penetration. These may be used for a variety of ophthalmic procedures, including, but are not limited to, the injection or drainage of fluids. This includes minimally invasive treatment of retinal tears or RRDs by delivery of treatment agents, such as viscoelastic substances, aimed at, for example, forming a temporary choroidal buckle. For example, a technique referred to herein as the ST procedure may be performed, which involves delivering a treatment fluid, such as a viscoelastic agent, into the suprachoroidal space for RRD repair. Various devices for performing the ST procedure and for delivering the treatment fluid in a more predictable manner are described herein. In another embodiment, an ophthalmic procedure including the ST procedure may further include the aspiration of fluids from the patient's eye, such as subretinal fluid / hemorrhage or suprachoroidal fluid / hemorrhage. In another embodiment, an ophthalmic procedure performed independently of the ST procedure may include the aspiration of fluids from the patient's eye.

[0053] The various embodiments described herein are designed to be minimally invasive, so that ophthalmic procedures can be performed in a simple medical setting, such as a clinic, or in an operating room, depending on the operator's judgment and the location of the injection site. For example, in more posterior areas such as the macula, a conjunctival incision may be required, in which case it is preferable to perform the procedure in an operating room using a wide field of view. However, these procedures can also be performed in other medical settings, such as outpatient clinics. This is because the various embodiments described herein, which provide access and precise localization, advantageously allow for the removal of fluid from the eye using a needle and / or the injection of fluid, such as a viscoelastic agent or drug, into the SCS or other areas of the eye without using more invasive incision / catheterization methods. Advantageously, the devices and methods described herein provide precise ocular localization and precise needle depth penetration outside the sclera, thus facilitating the performance of various ophthalmic procedures. As a result, the risks associated with performing these ophthalmic procedures are reduced, and the success rate of the procedures and patient outcomes may be improved. Furthermore, the precise localization and needle depth accuracy techniques described herein enable needle insertion that is relatively less invasive compared to surgery, potentially allowing patients to achieve faster recovery with little to no recovery period involving activity restrictions. This is less likely to occur with more invasive, conventional operating room techniques.

[0054] Referring to Figure 1, an exemplary embodiment of an ophthalmic treatment device 100 for performing various ophthalmic procedures, including treatment of retinal tears or RRDs, in accordance with the teachings of this specification is shown. The ophthalmic treatment device 100 includes a probe 101 and a fluid actuator 112. The probe 101 includes a body 102, a conduit 104 which may also be called an injection conduit, and a needle 106. The body has a longitudinal axis 102L and a distal end 103 which includes a curved portion 102c with respect to the longitudinal axis 102L. The longitudinal axis of the distal end 103 may be at an angle with respect to the longitudinal axis 102L of the probe 101, or it may be straight (i.e., parallel to the longitudinal axis of the probe). In at least one embodiment, the distal end 103 may also be curved according to a radius of curvature, slightly curved, or straight (or at a very shallow angle), for example, when positioning at a more anterior scleral position. The injection conduit 104 is configured to receive fluids, such as treatment fluid, and inject them into areas of the eye, such as the suprachoroidal space (SCS) of the patient's eye, to treat retinal detachment or retinal tear, or to inject therapeutic agents into areas of the eye, such as the SCS or subretinal space, to treat the retina or other eye diseases. The needle 106 is located at the distal end of the probe 101 and has a needle conduit 106c that is fluidically coupled to the injection conduit 104, which is for injecting treatment fluid into the SCS of the eye, or, depending on the ophthalmic procedure, into other locations of the eye, such as the subretinal space, choroid, or intravitreous space. The proximal end of the needle conduit 106c is fluidically coupled to the injection conduit 104.

[0055] During use, the tip of the needle 106 and the distal end of its corresponding needle conduit 106c are positioned at the injection site (e.g., within the SCS of the patient's eye). Therefore, the needle 106 is preferably positioned along the distal end 102c of the probe 101, preferably on the side of the probe and not on the tip (i.e., not on the most distal end face of the distal end of the probe). This ensures that the needle 106 is approximately perpendicular / substantially perpendicular to the tangent to the scleral surface (and also approximately perpendicular to the longitudinal axis of the distal end 103) before insertion into the sclera, resulting in the needle 106 being inserted along a direction toward the center of the eyeball (e.g., the center of the patient's eye). Therefore, the needle 106 is preferably retracted so as not to protrude beyond the surface of the distal end of the probe positioned adjacent to the eye. Once the needle 106 is in place, it can then extend, resulting in it extending into the eye from the exit position on the surface of the distal end of the probe. A small opening may be present at the exit position, positioned to surround the needle 106 when it is extended, so that the needle is substantially perpendicular to the tangent to the side of the distal end of the probe at the exit position. Furthermore, in at least one embodiment, a guide mechanism and / or electric / manual stepwise advancement of the needle may be used to properly insert the needle 106 into the sclera and advance it to a desired depth such as the SCS. This allows for a more accurate determination of the insertion depth of the needle tip, as the needle 106 penetrates the sclera to a depth equal to the length of the needle, and for other reasons described below. The needle 106 may be selected from needles of any gauge, but is preferably selected from 21 to 31 gauge needles, such as a 30 gauge needle or a 27 gauge needle.

[0056] The probe 101 has a shape factor that allows its proximal portion (e.g., the upper portion when the probe is vertical, as shown in Figures 1 and 2A) to be held by hand. The distal portion 102c of the probe has a shape similar to the “working end” of a scleral compressor, or a larger spherical tip, and the longitudinal axis of the distal portion 102c may be at an angle to the longitudinal axis 102L. The spherical tip may have a thickness of, for example, about 3 mm to about 30 mm. For example, the width of the distal end of the probe, which is positioned adjacent to the patient’s eye during an ST procedure, is usually large enough to accommodate the length of the needle and several other components, so the width / thickness of the distal end of the probe 101 may be about 3 mm to about 30 mm, or more preferably about 4 mm to about 15 mm. Furthermore, the length (i.e., arc angle) of the curved end portion 103 of the probe 101 may be selected depending on the position of the eye into which the needle is inserted. The radius of curvature of the distal end 103 may be selected to be similar to (i.e., nearly identical to) the curvature of the eye (e.g., the sclera) into which the needle is inserted. Typically, the arc angle of the distal end of the probe may range from approximately 0 to 90 degrees, 20 to 90 degrees, 0 to 50 degrees, or 30 to 40 degrees, depending on the application. Probes with different arc angles of the distal portion may be used when localizing at different scleral locations. For example, an arc angle of approximately 0 to 30 degrees may be used at anterior locations. In another example, an arc angle of approximately 15 to 45 degrees may be used at the midperiphery. In yet another example, an arc angle of approximately 30 to 60 degrees or greater may be used at more posterior locations. Similarly, probes with different lengths of the curved portion of the distal end (defined by the arc angle of the distal end) may be used when localizing at different scleral locations. Please note that the diagrams of the distal ends of probes 101 and 201 (see Figure 2A) are provided as examples only and are not to scale.

[0057] The distal end of probe 101 may be used by a healthcare professional, such as an ophthalmic surgeon or vitreoretinal surgeon, hereafter referred to as the user, to manipulate it along the curvature of the eye towards a posterior (i.e., posterior) position, or towards any anterior or posterior position along the eye, depending on the ophthalmic procedure being performed. For example, posterior manipulation may be aimed at locating a retinal tear and compressing the sclera of the patient's eye during use. The placement of the distal end of probe 101 on the posterior surface of the eye is such that it aligns with the desired position (e.g., the location of the retinal tear in this example), which may be confirmed by indirect ophthalmoscopy. For example, the user may be examining the posterior part of the eye with a 28D or 20D lens and an indirect ophthalmoscopy. One hand of the user may be holding the lens, and the other hand may be holding probe 101 or 201, with the indirect ophthalmoscopy mounted on the user's head. The lens and / or indirect ophthalmoscopy may also be considered guide tools. This allows the user to determine (e.g., locate) the location of the retinal tear or RRD tear in the patient's eye during use. In addition, the scleral compressor shape of the distal end of probe 101 or 201 allows the user to access a large portion of the posterior segment of the patient's eye and to apply pressure (pull down) to the sclera of the patient's eye. This scleral compression allows the user to better visualize the retinal tear by viewing the inside of the eye with indirect ophthalmoscopy. Once the push-down is visualized and it is found to be sufficiently centered around the retinal tear, the user may begin injecting a treatment fluid using one of the techniques described herein. In the operating room, it is also possible to visualize the inside of the eye with a wide field of view and direct illumination, or with illumination with a chandelier light source.

[0058] In at least one embodiment of the devices described herein, the distal end of any of the probes described herein is large enough to accommodate (e.g., space) other elements that provide extension / retraction of the needle and other functions. For example, one or more sensors may be located at the distal end of the probe. Alternatively, or in addition to sensors, the distal end may have one or more openings or windows that perform various functions, such as allowing the needle to extend from and retract into the distal end, and allowing a light beam from a light source to be transmitted from the probe end. The light beam may be used to illuminate the sclera, thereby allowing the user to know exactly where the needle insertion point is, for example, its position relative to the location of a retinal tear. In one or more embodiments, the sensors, openings, windows, or other features may be located along the side surface of the distal end and not at the tip of the distal end 102e (i.e., the end faces of probes 101, 201 intersecting the longitudinal axis of the distal end of the probe).

[0059] In an example of a procedure involving fluid injection (e.g., retinal tear or RRD treatment), a fluid actuator 112 is fluidically coupled to a needle 106 and is controllable (e.g., by the user) to move a fluid, such as a treatment fluid, from one or more probe conduits (e.g., injection conduit 104) through the needle conduit 106c to the SCS or another location in the eye. The fluid actuator 112 may be fluidically coupled to a treatment fluid source 116 via a tube 118 (which may also be called a tubing or line), thereby allowing the fluid actuator 112 to move the treatment fluid into the injection conduit 104 through the tube 114. In other embodiments, the fluid actuator 112 may be housed within the body of the probe 102, and the tube 114 may also be housed within the body of the probe 102, or may not be necessary. When a fluid other than the treatment fluid is injected, the treatment fluid source 116 may more generally be called a fluid source. The treatment fluid may consist of a viscoelastic agent, in an example of retinal detachment treatment. However, more generally, in at least one embodiment described herein, the treatment fluid may include any combination of any drug, gene therapy, stem cells, sustained-release implant, viscoelastic substance, hydrogel, gas, or other pharmacological agent or material to be delivered to any of the suprachoroidal space, subretinal space, sclera, choroid, or other ocular locations. The probe 101 may have a port 110 for fluidly connecting the tube 114 to the injection conduit 104. The fluid actuator 112 may include a pump used to apply injection pressure to move the treatment fluid from the treatment fluid source 116 through the injection conduit 104 to the tip of the needle conduit 106c and further into the patient's eye. The injection pressure used may be predefined but may vary under certain circumstances. For example, the injection pressure may vary based on certain instrument factors such as the lumen size of the tube and the size of the needle conduit 106c, as well as certain preferences that the user may have. For example, the injection pressure may vary in the range of about 35 mmHg to about 70 mmHg, but about 50 mmHg may be preferred. For example, the injection pressure used while the needle 106 is being advanced / extended into the patient's eye may be approximately 50 mmHg, so that the user can see the bleb that forms in the SCS (i.e., "SCS bleb").A bleb refers to a blister-like space formed between two tissue layers by a fluid, drug, or material. Bleb formation can vary based on the viscosity and other rheological properties of the fluid, drug, or material. When a user observes SCS blebs forming, they may decide to increase or decrease the injection pressure to increase or decrease the injection rate.

[0060] The treatment fluid source 116 may be a container (e.g., an infusion container, which may also be called an infusion fluid container), a bag, or a cartridge containing the treatment fluid to be supplied to the probe 101 during use. For example, if the treatment fluid is in a cartridge, the cartridge may be removablely slid into the body 102 of the probe 101 and fluidly coupled to the conduit 104. In such a case, a fluid port may not be necessary. In this case, where the cartridge can be inserted into the body of the probe, the cartridge may be a cylinder having an opening covered with a membrane at one end, and further, a spike that pierces the membrane may be present in the device near the proximal end of the conduit 104, and this spike allows the fluid from the cartridge to enter the conduit 104 and then fluidly communicate with the needle conduit 106c. An actuator, such as a lever or dial (neither of which are shown), may be used to apply pressure to move the fluid through the needle conduit 106c. In at least one embodiment, the probe may be pre-loaded with the treatment fluid, or filled with the treatment fluid immediately before use by inserting a container, bag, or cartridge, or by filling a fluid chamber contained within the probe.

[0061] In some cases, the fluid actuator 112 may be a motor that moves an object that applies a force to move the fluid into the eye. The force may be mechanical or pneumatic and is applied at a point between the fluid source and the needle tip to ultimately cause the fluid to be injected into the patient's eye. The fluid actuator 112 may be coupled to a pedal and / or switch in either a wired or wireless manner, and these pedals and / or switches may be configured to be controlled by a user using device 100 to perform an ophthalmic procedure such as the ST method on a patient with an eye having a retinal tear or RRD. While the user holds the probe 101 in one hand, the user may use one of their feet to control the fluid actuator 112 via the pedal, or the same hand if the switch used to control the fluid actuator 112 is on the probe 101. Meanwhile, the user's other hand holds a lens used to view the inside of the patient's eye using an indirect ophthalmoscope. In an alternative embodiment, the fluid actuator 112 may be voice-activated, and the user may issue specific voice commands to activate and deactivate the actuator. When the fluid actuator 112 is activated, the treatment fluid is supplied from the treatment fluid source 116 through tubes 118 and 114 to the injection conduit 104, and then to the needle conduit 106c, and injected into the patient's eye.

[0062] Alternatively, if the target location is the SCS, the user may activate the fluid actuator 112 to begin applying injection pressure when the needle 106 is located within the sclera (there is little to no flow when the needle is within the sclera, as the sclera obstructs the flow). The needle 106 is then slowly advanced while continuing to apply injection pressure, and as soon as the needle tip enters the SCS (the SCS provides little to no resistance to the fluid flow from the needle), the fluid begins to flow and a choroidal buckle begins to form. By applying injection pressure while the needle is slowly advancing, a choroidal bleb is formed as soon as the needle enters the SCS and before the needle penetrates too deeply into the eye (i.e., into the choroid). As soon as the needle enters the SCS and a choroidal bleb forms, this can act as a visual notification and as a safety mechanism to prevent the needle 106 from entering deeper structures such as the choroid or subretinal space, for example, when treating a retinal tear or RRD. A decrease in injection resistance and an increase in fluid flow rate can also provide feedback to the user that the needle is in place and should not be advanced further. Injection resistance is the mechanical resistance to the flow of fluid out of the needle and can be measured by a pressure sensor (pressure increases when attempting to inject against high resistance) or a flow sensor (if resistance is high, the flow rate remains low even when pressure is applied for injection). The general relationship is pressure = flow rate × resistance.

[0063] Therefore, one or more sensors capable of measuring these values ​​may be included in the device to provide data that may be called positional data. It should be noted that this bleb is a complete bleb and not a pre-bleb, and is used to identify the space in which the treatment fluid should be injected, as there is no flow while the needle 106 is in the sclera and there is flow as soon as the needle enters the SCS. Thus, when the user activates the fluid actuator 112 and it is activated when the needle is in the SCS, the treatment fluid is injected into the SCS of the patient's eye, and when the user stops activating the fluid actuator 112 and it becomes deactivated, the injection of the treatment fluid stops. This device configuration allows the user to concentrate more on holding the probe 101 in a precise position during ophthalmic procedures such as ST procedures, while the treatment fluid is delivered in a controlled manner by switch / foot pedal / voice control. For example, depending on the embodiment of the probe / device, voice commands for the automatic operation of the fluid actuator may be provided, such as "inject now" or "stop injection". The system may also have confirmation questions, such as "Do you want to start injection?", to which the user answers "yes / no". The command "Stop injection" can immediately disable fluid operation. Similar voice commands such as "Start suction now" and "Stop suction" can be used for suction.

[0064] The needle 106 has a needle position when it is extended from the body of the distal end of the probe, which in the embodiment of Figure 1 is called the injection position (in some embodiments, there may also be an injection position in which the needle is extended to a certain length to drain a specific area of ​​the eye). The needle 106 also has a needle position when it is fully retracted within the distal end of the probe, which is called the retracted position. In some cases, it may be preferable for the needle to be in the retracted position while the probe is positioned in the desired location to avoid scratching or otherwise damaging the eye, and only then extending the needle to the injection position. In the injection position, the end of the needle 106 (i.e., the needle tip) is adapted to extend about 0.3 mm to about 1.5 mm into the patient's SCS to perform the first injection. This range of needle length is due to differences between patients and their positions on the eyeball, which may have different scleral thicknesses, potentially requiring the tip of the needle 106 to be inserted to a deeper or shallower depth. In at least one embodiment, the probe 101 may include a controllable (e.g., user-adjustable) needle actuator 108 for adjusting the needle position. For example, if the user needs to perform a second injection on a patient after performing a first injection, the user can use the needle actuator 108 to further extend the tip of the needle 106 so that it is inserted to a deeper position in the patient's eye, e.g., about 1 mm to about 2 mm, to perform the second injection into the patient's SCS. The needle actuator 108 may also be used to move the needle from a retracted position to an extended position, or from an extended position to a retracted position. The needle actuator 108 may be operated physically by the user or by voice commands, as described for fluid actuators. Generally, 0.8 mm may be used as a starting point, and the needle tip may be further extended if there is no choroidal ridge. However, in some positions a 0.8 mm needle extension may be too deep, and the user may need to use a shorter initial needle extension for the needle 106. The depth can be assessed by the user under visual inspection with an indirect ophthalmoscope or using a wide-angle field of view in the operating room. However, it should be noted that in some cases the scleral thickness may be less than 1 mm.In that case, the extension of needle 106 will also be less than 1 mm.

[0065] Since the tip of the needle 106 can be extended to be inserted into the patient's eye at different depths, the needle actuator 108 may include a needle position indicator (not shown) that visually indicates the possible insertion depth at the current needle position. For example, the needle actuator 108 may be a slider that is physically coupled to the needle 106 and moves the needle, changing the distance between the tip of the needle 106 and the distal end of the probe 101 from which the needle extends, and the needle position indicator may include a scale line or tab on the slider and a numerical scale on the probe body 102 that indicates the length that the tip of the needle 106 can be inserted based on the current position of the needle 106. The slider may be manually controlled by the user to advance the needle 106 in small increments, for example, 0.1 mm at a time. Alternatively, a dial and gear assembly or lever may be used to allow the user to manually extend / retract the needle 106. In at least one embodiment, the needle actuator 108 may be motorized.

[0066] In an alternative embodiment, since it may be difficult for the user to confirm the needle length with a position indicator while observing the patient's eye with a handheld lens, a speaker may be used to generate an audio output that informs the user of the length of the needle 106 as the needle position moves, thereby allowing the user to perceive the needle depth. For example, this may be done using a movement sensor coupled with a needle actuator 108 and a control unit 250 (see, for example, Figure 2C), which detects the movement of the needle position and generates needle movement data, which is processed by the control unit 250, and the control unit 250 generates an audio signal that is provided as an audio output via a speaker 268. Alternatively, a series of ridges may be provided on the body 102 of the probe 101 at known distances, such as 1 mm, and bumps may be provided on the needle actuator, so that each time the needle actuator 108 extends the tip of the needle 106, the bump passes over one of the ridges on the body 102, producing a sound such as a click, informing the user that the needle tip has been extended by a distance equal to the ridge spacing on the body 102.

[0067] In at least one embodiment, the probe 101 may further include a sensor 107 positioned within the injection conduit 104 or needle conduit 106c to measure the injection resistance near the distal end of the needle 106. In the exemplary embodiment shown in Figure 1, the sensor 107 is located within the distal end of the conduit 106c. The sensor may be a pressure sensor, and the injection resistance may be considered to be the back pressure present at the distal end of the needle conduit 106c, and it also refers to the resistance the treatment fluid encounters when the treatment fluid is injected into the eye. Alternatively, the sensor may be a flow sensor that measures the fluid flow while the injection pressure is applied. Alternatively, the sensor may be a pressure sensor or resistance sensor for measuring needle insertion resistance. Insertion resistance is the mechanical resistance to the movement of the needle into the eye and can be measured using a mechanical force sensor or pressure sensor. The sclera, SCS, choroid, and subretinal space of the eye all have unique insertion resistance values ​​due to their different densities / materials at these locations in the eye. Therefore, the sensor 107 can be used to measure insertion resistance, which can be used to estimate whether the tip of the needle 106 is in the sclera, SCS, or any other part of the patient's eye. For example, in the case of an injection resistance sensor, the inventors found that the injection resistance is high when the tip of the needle 106 is located in the sclera, but decreases as the tip of the needle 106 advances into the SCS, and a bleb forms at the tip of the needle 106 if the injection has already been initiated by applying a sufficient amount of injection pressure. If the user initiates the injection when the resistance is low, the treatment fluid propagates well into the injection site. Alternatively, the user can slowly advance the needle 106 while slowly applying injection pressure while the needle tip is in the sclera, and then when the insertion resistance or injection resistance decreases, it indicates that the needle tip is in the SCS, a choroidal bleb is visible, and the user can then increase the flow rate of the treatment fluid.For example, actuator control may be implemented such that the amount of treatment fluid injected increases when a switch or foot pedal connected to the fluid actuator 112 is pressed more forcefully (e.g., linearly, i.e., the flow rate of treatment fluid increases as the force increases), or the amount of treatment fluid injected may be automated based on a decrease of at least about 50% in the measured injection resistance or insertion resistance. For example, this may be performed by a processor 270 of the control unit 250 upon receiving and processing the measured insertion value (see, for example, Figure 2C). Another alternative is to initially create a choroidal bleb further forward, where it is easier to insert the needle 106 into the correct position, and then, once a choroidal bleb localized forward has formed, the length of the needle can be slightly increased, followed by a more substantial injection in the SCS, thereby causing the choroidal bleb to propagate further backward toward the location of the retinal tear.

[0068] Sensor 107 may also be any combination of an electrical impedance sensor, a mechanical resistance sensor, and a flow sensor, which are positioned within the probe conduit or needle conduit, or on the external surface of the probe or needle, to measure insertion, injection, or electrical resistance. The resistance measured at the approximately distal end of the needle approximates the position of the needle tip within the eye, thereby determining whether the needle tip is in the sclera or SCS of the eye. The mechanical resistance sensor may be implemented using a pressure sensor or a force sensor. The electrical impedance sensor and flow sensor are described in more detail below.

[0069] In at least one embodiment, device 101 may have a processor and display (e.g., an LED display) for acquiring and displaying measured insertion, injection, or electrical resistance, thereby providing the user with resistance feedback prompts to inform the user when to begin injection. In some embodiments, the display may be optional, such as in the standalone device shown in Figure 3H. Alternatively or additionally, in at least one embodiment, the processor may be configured to automatically activate a fluid actuator to inject treatment fluid when resistance feedback indicates that the needle tip is in the correct position for injection of treatment fluid. In at least one embodiment, the measured resistance value may be compared to a resistance threshold, and when the measured resistance value falls below the resistance threshold, a resistance feedback prompt may be provided to the user via visual display or audio, and / or the fluid actuator may be activated to automatically begin injecting treatment fluid. Alternatively, in at least one embodiment, the measured resistance value may be analyzed to determine a rate of change, and when the magnitude of the rate of change exceeds a resistance change threshold, a resistance feedback prompt may be provided to the user visually and audibly, and further / or injection may be automatically initiated. Such thresholds can be determined experimentally and may depend on any combination of the patient's age, sex, and whether the patient has an ocular condition that causes the sclera to become thicker or thinner.

[0070] As described above, in at least one embodiment, the electrical impedances of different tissue types may differ, so probes 101 and / or 201 may use electrical impedance to detect whether the needle tip is in the sclera or SCS. For example, a resistance sensor could be an electrical impedance sensor, which may include a measuring electrode located at or near the tip of needle 106, and a reference electrode similarly located near the tip of needle 106 or another part of needle 106 or probe 101, 201, and connected to ground. As the needle tip extends into the patient's eye, impedance measurements are taken as the measuring electrode comes into contact with the scleral tissue, and the value is approximately a first value, which may be called the scleral impedance. As the needle tip extends further and enters the SCS, impedance measurements continue, and the value is approximately a second level, which may be called the SCS impedance. Scleral impedance is different from SCS impedance. Therefore, the impedance value can be measured as the needle tip extends into the patient's eye, and when the measured impedance value changes from the scleral impedance value to the SCS impedance value, a signal may be provided to notify the user to start injecting the treatment fluid, and further / or the fluid injection may be started automatically as described above.

[0071] It should be noted that the depth of the tip of needle 106 when it is inside the SCS may vary from patient to patient and from one position to another in a given patient's eye. Therefore, in at least one embodiment, the tip of needle 106 may be extended to an initial length for SCS injection, after which the tip of needle 106 may be slowly extended little by little (e.g., incrementally) until the measured insertion resistance indicates the proper position of the tip of needle 106, and the injection may be performed little by little (e.g., incrementally). For example, when the distal end 103 of probe 101 is in the area of ​​a retinal tear or rupture (which is observed by indirect ophthalmoscopy based on the impression formed by the distal end of the probe, or using a wide-angle field), needle 106 may be controlled to slowly penetrate the sclera, for example in an incremental manner, which may be done electrically, for example, by using a stepping motor. As the tip of needle 106 extends, the user can observe the needle tip pressing against the posterior sclera, or, with the aid of light shining through the lumen of the needle, can visualize the needle penetrating the sclera of the eye, allowing the user to visually confirm that needle 106 is not penetrating too deeply. The user can continue to extend needle 106 to a set length such as approximately 0.3 mm, 0.9 mm, 1 mm, or 1.2 mm, or to any depth selected by the user, and / or the user can limit the penetration depth of the needle using visual cues. For example, the movement of the needle tip can be observed using a guide tool (described below), which may include observing the indentation left by the needle, observing when the needle has passed through the sclera and reached the SCS, and observing when the fluid begins to be injected if injection pressure is applied, thereby allowing the user to stop the extension of the needle to prevent penetrating deeper structures. These methods provide safety measures to prevent excessive penetration. The stepwise extension of the needle 106 may be implemented using a processor-controlled stepping motor coupled to a slider, rotary dial, or similar device, which slides / extends the tip of the needle 106 in an incremental manner away from the distal end of the probe 101, and retracts the needle 106 into the distal end of the probe tip.A user-controlled switch or foot pedal may be present, communicatively coupled to a stepping motor, allowing the user to have finer control over the incremental extension and retraction of the needle 106 during use. The switch or foot pedal mechanism may be identical to that used for automatically injecting the treatment fluid, and this mechanism may be configured to include two switches or two buttons on the probe 101, or two parts of a foot pedal, allowing the user to operate one of the switches or a first part of the pedal to move the needle, and then operate the other switch or a second part of the pedal to initiate the injection or aspiration of the treatment fluid (see, for example, below). Alternatively or additionally, in at least one embodiment, voice control may be used to control the extension / retraction of the needle. These mechanisms may also be applied to other probes described herein, such as probe 201.

[0072] For example, during use, with the needle retracted, the user presses the eyeball with the distal end of probe 101 or 201. Once the correct position on the eyeball is identified, the user activates the motor control, and needle 106 slowly begins to extend. As needle 106 extends, the actuator for injecting the treatment fluid is also activated, but because sufficient injection pressure is not used to overcome the injection resistance within the sclera, the treatment fluid does not flow out from the needle tip while the needle tip is in the sclera and does not flow out until the needle tip enters the SCS, where a bleb automatically forms. Once the bleb begins to form, the user can increase the flow rate to complete the delivery or continue at the same flow rate. Alternatively, in at least one embodiment, the user can control the device to decrease the flow rate, thereby delivering the treatment fluid more slowly and making the injection more controllable. In at least one embodiment, probe 101 or 201 may have a flow sensor for detecting when the flow of treatment fluid from the needle tip begins. When the flow of the treatment fluid is detected, if a motor is used to extend the needle tip, that motor may be turned off to stop the advancement of the needle tip. At this point, the needle may be locked in place, and the treatment fluid may continue to be injected until a sufficient amount is injected (as described herein). Also, as the fluid flows into the SCS, the intraocular pressure may rise.

[0073] In at least one embodiment, two separate input mechanisms can be used, including one (e.g., a first) mechanism / input device for controlling a fluid actuator and another (e.g., a second) mechanism / input device for controlling a needle actuator. The first and second mechanisms / input devices may be dials, sliders, or buttons, respectively.

[0074] In an alternative embodiment, any of the probes described herein may include a pressure sensor, which may be located near the distal end of the probe or at another suitable location and may be coupled to the injection conduit 104 and used to acquire intraocular pressure measurement data. The intraocular pressure data may be processed by a processor to alert the user when the intraocular pressure reaches an intraocular pressure limit to which it is desirable to stop further injection of the treatment fluid to avoid any damage to the eye. This pressure limit may be predefined and adjusted based on the type of ophthalmic procedure being performed and the condition of the eye being treated. For example, the intraocular pressure threshold may be approximately 40 mmHg, approximately 60 mmHg, or approximately 80 mmHg. Intraocular pressure measurement may be based on scleral parameters or other ocular tissue parameters sensed by the device. The device may then indicate to the user when the intraocular pressure reaches 40 mmHg, 60 mmHg, or 80 mmHg. In the inventors' experience, pressure may rise with choroidal injection, which may cause the central retinal artery to occlude or pulsate. In these cases, based on the inventors' experience, the user may perform anterior chamber puncture to lower intraocular pressure. The removal of fluid from the anterior chamber may be done slowly and in small amounts to avoid bleeding of the posterior segment at the needle puncture site. In some cases, the downstream retina may be slowly drained, or some of the treatment fluid may be removed using the device, in order to lower intraocular pressure.

[0075] In an alternative embodiment, a robot may be used, which automatically advances the needle to a desired position using sensor feedback. The robot may receive sensor data, such as injection or insertion resistance, and use this data to slowly advance the needle. Once a desired sensor value is reached, the robot may begin injection until the desired amount is injected. The robot may also use sensor data, such as intraocular pressure and / or injection resistance, to determine when to stop injecting. The surgeon may override the robot at any time to change the needle position or to control the injection of the treatment fluid.

[0076] In at least one embodiment, the device 100 may include a guide tool that can provide guidance based on electrical, mechanical, optical, acoustic, force, pressure, flow rate, image, or tomographic data. For example, in at least one embodiment, the guide light tool includes a light source 122 that generates a guide light beam. The guide tool is optically coupled to the distal end of the probe 102 via an optical fiber 120 coupled to the port 110. The probe 101 may have an internal optical fiber 109 having a proximal end connected to the port 110 and a distal end located at the distal end of the probe 101, the internal optical fiber 109 for transmitting light from a guide tool to the distal end of the probe 101 (for example, the optical fiber 109 may pass through or adjacent to the needle conduit 106c), thereby emitting light at the distal end of the probe 101, which the user can see while observing the patient's eye in indirect ophthalmoscopy, thereby knowing whether the needle 106 is in a scleral position, in the SCS, or in a deeper position in the subretinal space. The optical fiber 109 is thin enough that it does not interfere with the injection of the treatment fluid. The light provided by the optical fiber 109 may make visible a portion of the eye near the tip of the needle 106, such as the sclera or choroid, so that the tip of the needle 106 can be more accurately positioned (i.e., aligned) for injection of the treatment fluid. For example, when illuminating the tip of the needle 106 during use, such an optical fiber 109 may allow the user to visually confirm the needle tip in the eye when the needle 106 is in the suprachoroidal space (or when the needle tip is too shallow in the sclera or too deep in the subretinal space). If the optical fiber 109 is thin, it may be necessary to increase the light intensity to improve visualization. Alternatively, if the injection conduit 104 is formed using a material with sufficient internal light reflection properties, the injection conduit 104 may be used instead of the optical fiber 109. The optical fiber 109 may be replaced with a conduit corresponding to a different guidance modality, for example, when a non-optical guide tool such as an ultrasound imaging device is used.

[0077] When visualization is performed using the optical fiber 109, changes in light intensity and / or color may occur as the needle tip extends from the sclera into the SCS (and choroid, subretinal space, and / or other parts of the eye), thereby providing the user with a visual cue that the needle tip is inside the SCS (or any other part of the sclera, choroid, subretinal space, or other part of the eye). The light intensity may change further when the treatment fluid is injected. In at least one embodiment, the light transmitted by the optical fiber 120 may have a color (other than white) to help the user identify the light during visualization, and the light transmitted by the optical fiber may be called a guide beam. For example, its color may be blue, green, or red. In either the case of white light or colored light, when the needle 106 is inside the sclera, there is an internal dull (e.g., attenuated) colored light that is seen when the colored light passes through the eyeball / part. As needle 106 advances through the sclera, the colored light increases in intensity or becomes visible for the first time, and this change can be perceived by the user, allowing the user to know that the needle has passed through the sclera and is in the choroidal supraluminal space. The sclera is an opaque tissue composed of densely packed collagen fibers. Therefore, less light is transmitted when light is shone from outside or inside the sclera. Also, the appearance of light may differ when it is inside the sclera compared to when it is inside the SCS. This is because the color of light can change depending on the tissue through which it is passing. For example, when light is directly beneath the choroid, the color may change compared to when it is inside the sclera. This is because different wavelengths of light can be absorbed differently by the sclera and SCS (as well as the choroid and retina), and therefore these different wavelengths of light can be useful in distinguishing whether the needle tip is in a scleral position, an SCS position (and other positions). Here, wavelengths may correspond to, for example, red light, blue light, or green light. Changes in light intensity and / or color are visible to the user examining the patient's eye with an indirect ophthalmoscope and focusing lens. If the colored light becomes more clearly visible, this may occur when needle 106 has passed through the sclera and entered the SCS, but the user can then begin the injection.

[0078] In at least one embodiment, the spot size of the guide light beam used may range from about 50 microns to about 500 microns, and the intensity of the light beam may be selected such that changes in the properties of the light are visible to the human eye and / or detectable by an optical sensor. In at least one embodiment, in addition to the optical fiber that transmits white light for observation / imaging, an optical fiber for transmitting the guide light beam may be provided. The white light beam may be larger and may be provided by an optical fiber coupled to the distal ends of probes 101, 201.

[0079] Note that if the needle tip is directed perpendicularly into the sclera, a change in light intensity may occur (for example, the light intensity may be highest in this case). Alternatively, if the light beam is polarized, a polarization-sensitive sensor may be used to ensure that the needle tip is perpendicular to the needle insertion performed in the sclera.

[0080] Therefore, in at least one embodiment, any change in the optical properties of a light beam transmitted into the eye via a probe can be detected by sensing the reflected light using an optical sensor to obtain reflected light data, and analyzing the reflected light data using a processor, where the optical properties may be intensity, wavelength (e.g., color), and / or polarization. Changes in the optical properties can be communicated to the user via the processor. For example, the sensor may be used to sense backscattered or reflected light of a specific wavelength to know when the needle has passed through the sclera. The reflectivity of the light returning to the sensor may differ when the needle is in the sclera compared to when the needle has passed through the sclera and entered the SCS.

[0081] Alternatively, in at least one embodiment, the guide tool may be an imaging and / or measuring device 122, such as an optical coherence tomography (OCT) device. The guide tool is optically coupled to the distal end of the probe 102 via an optical fiber 120 coupled to the port 110. The probe 101 may have an internal optical fiber 109 coupled to the port 110, or the injection conduit 104 may be used to: (a) transmit light from the OCT device to the distal end of the probe 101 so that light is emitted from the distal end of the probe 101 into an area of ​​the patient's eye, such as the sclera or choroid, where the tip of the needle 106 is located; and (b) transmit the light reflected from this area of ​​the patient's eye to the OCT device 122, which may generate and display an OCT image based on its reflected light. The user may view the OCT image to more accurately position (i.e., align) the tip of the needle 106 to the appropriate position for injecting the treatment fluid. In at least one embodiment, OCT images may be used to ensure vertical alignment by measuring the scleral thickness and adjusting the probe angle to reduce (i.e., preferably minimize) the scleral thickness. This indicates a vertical passage (i.e., shortest path) rather than an oblique approach during needle insertion.

[0082] It should be noted that in at least one embodiment, other optical guiding tools may be used, such as optical coherence elastography (OCE) devices, endoscopic imaging devices, light intensity detection devices, light scattering detection devices, light wavelength detection devices, or light polarization detection devices. In the case of endoscopy, an optical camera is used so that the user can confirm the position of the needle tip on a monitor. This may also allow the user to see the scleral fibers and know, for example, when the needle tip has entered the SCS.

[0083] The various optical imaging devices described herein may include, as an implementation, the use of a flexible optical fiber (or other “optical conduit”) that is bent to exit from the side of the distal end of the probe. Alternatively, in some cases, a forward-looking imaging tool may be used with a 45-degree mirror, so that the tool can produce an image with a field of view (i.e., direction of the eye) perpendicular to the longitudinal axis of the distal end, where this direction is the position through which the needle penetrates during use, and not the direction of the tip of the distal end.

[0084] It should also be noted that various optical imaging devices and one or more sensors described herein within the probe may be analyzed, thereby determining positional data indicating the location of the probe's needle tip during use. A combination of imaging devices and one or more sensors may provide an assessment of whether the needle is in the sclera or has completely passed through the sclera into the choroidal space. For example, needle penetration depth may be determined by matching the optical, mechanical, electrical, or other outputs of the imaging devices and sensors to different values ​​of the characteristics of different types of ocular tissue. Needle penetration depth may also be determined by counting the number of times the output measurement changes and correlating this with the anatomical structure of known tissue layers of the eye, where each change indicates the probe has passed from one tissue type to another. In general, needle penetration depth may be determined according to the position of the imaging devices and / or sensors, and the needle tip position is calculated relative to its reference position based on the known (calibrated) physical configuration of the probe components. The needle penetration depth data (i.e., position data) can be displayed by the control unit 250 or communicated to the user, for example, through voice feedback.

[0085] In yet another alternative form, in at least one embodiment, the guide tool may be an imaging device 122, such as an ultrasound (US) imaging device. The guide tool is coupled to the distal end of the probe 102 via a wire or cable 120 coupled to a port 110. The probe 101 may have an internal wire coupled to the port 110 and a US transducer located near the distal end 103 of the probe 101. The US transducer can transmit ultrasound from the distal end of the probe 101 to an area of ​​the patient's eye, such as the sclera or choroid, where the tip of the needle 106 is located; and (b) US waves reflected from this area of ​​the patient's eye are received by the US transducer, which converts them into a corresponding electrical signal that is sent to the US imaging device 122, which may generate and display a US image based on the reflected US waves. The user may observe the US image to more accurately position (i.e., align) the tip of the needle 106 to the appropriate position for injecting the treatment fluid. Furthermore, in at least one embodiment, US data / US images may be used to align the needle so that it enters the sclera nearly perpendicularly.

[0086] The treatment fluid obtained from the treatment fluid source 116 may be a viscoelastic agent such as hyaluronic acid, which may have a duration of several weeks (2-8 weeks). For example, sodium hyaluronate 2.3% may be used, which may have a duration of approximately 2-3 weeks. However, treatment fluids with longer durations may be preferred, such as "cross-linked" hyaluronic acid or other modified hyaluronic acid. For example, restylane may be used, which may last for several months. Alternatively, different compounds that are absorbable / inert and non-inflammatory may be used as treatment fluids. For example, sodium hyaluronate 1%-2.3%, restylane, or hydrogel spacers (soluble or insoluble) may be used.

[0087] In an alternative embodiment, the treatment fluid may include an inert gas or air.

[0088] It should be noted that in at least one alternative embodiment of device 100, the fluid actuator 112 may be provided by a syringe plunger, and the treatment fluid source may be housed within the syringe barrel / chamber. In this case, an assistant to the user may operate the plunger to perform the injection.

[0089] In another alternative embodiment, the injection conduit 104 may be pre-filled with treatment fluid, or a treatment fluid source may be incorporated within the injection conduit, so that the device does not need to be coupled to an external treatment fluid source. In such a case, the fluid actuator 112 may still be used to apply injection pressure in the same manner as described above, thereby allowing the user to concentrate one hand on operating the probe 101.

[0090] Referring to Figure 2A, a diagram of another example embodiment of probe 201 of ophthalmic treatment device 200 for treating retinal tears or RRDs or for delivering therapeutic fluids to the eye, in accordance with the teachings herein. Probe 201 has some similarities with probe 101 and therefore has similarly numbered components that operate in a similar manner, and these components will not be described in detail as they have already been described in relation to probe 101. However, probe 201 also has additional components that allow the user to aspirate fluid (actively or passively) from the patient's eye, which may be, for example, suprachoroidal fluid, hemorrhage, subretinal fluid (SRF), subretinal hemorrhage, or a portion of injected fluid in case of excessive fluid injection, and this procedure may need to be performed on a patient-by-patient basis. For example, probe 201 has a dual conduit design, which includes a drainage conduit for draining fluid from an area of ​​the eye, such as subretinal fluid, and an injection conduit for providing a treatment fluid to be injected into the SCS of the patient's eye (or to another location to treat another disease) to treat an RRD or retinal tear, as described above for probe 101. The drainage conduit may be located inside or outside the probe and fluidically coupled to a drainage tube that stores the drained fluid.

[0091] In an alternative embodiment, a probe is provided that may use a single conduit, which can function as both an injection conduit and an injection conduit at different times, provided that the discharged fluid is removed from the probe and does not interact with the injected fluid. In some cases, drainage may occur first, followed by injection. In other cases, fluid injection may occur first, followed by drainage at the same or a different location. In such embodiments, a valve or gate may be used to fluidically connect the single conduit to a fluid source or drainage container while injection and drainage are occurring, respectively. Thus, in at least one embodiment, an injection fluid container and / or an injection fluid container are connected to one or more probe conduits.

[0092] Figure 2A shows that the probe 201 has a double-cylinder design, with the inner cylinder surrounded by the outer cylinder, and one cylinder functioning as an injection conduit and the other as a discharge conduit. Thus, the probe 201 includes a cylinder that functions as an injection conduit 104, which can be pre-filled with a treatment fluid in a fluid cartridge that can be coupled to the injection conduit 104 as described for the probe 101. In at least one embodiment, the probe 201 may include a plunger 211 having a shaft 213, which is slidably received into a port 212 of the injection conduit 104. The plunger 211 has a thumb rest 215 that the user can press when injecting the treatment fluid. The user can then press the thumb rest 215 to inject the treatment fluid.

[0093] Alternatively, the probe 201 may not include the plunger 211, and instead, components similar to those used with the probe 101 of the device 100 (e.g., a fluid actuator 112, a pump(s) (not shown in Figure 1, but an example being pump 280 in Figure 2C), and tubes 114 and 118) may be used to inject the treatment fluid. Alternatively, in at least one embodiment, a hardware configuration such as the control unit 250 shown in Figures 2B and 2C may be used with any of the probes described herein to actuate the injection of the treatment fluid into the patient's eye. In this case, the control unit is separate from the probe (e.g., not contained within or housed with the probe). In such a design, the coupling for supplying the treatment fluid to the injection conduit 104 may be through the port 212, or alternatively, the port 212 may be absent, with the end of the injection conduit 104 sealed, while a lateral injection port 216 is used to supply the treatment fluid to the injection conduit 104. Therefore, in some embodiments, port 216 may be optional, or in other embodiments, port 212 may be optional. However, embodiments in which the control unit is housed within the probe may also exist (see, for example, the standalone probe / device in Figure 3H).

[0094] In at least one embodiment, the probe 101 may include one or more resistance sensors 107 located below the stopper 214 at the distal end of the plunger 212 adjacent to the treatment fluid. Alternatively, in some embodiments, such as those without a plunger 212, the resistance sensors 107 may be located within the needle conduit 106c, for example, near the distal end of the needle conduit 106, similar to those described for the probe 101. The resistance sensor(s) 107 operate as described for the probe 101.

[0095] The outer cylinder may act as a drainage conduit 228 for draining fluid, such as subretinal fluid, from a portion of the patient's eye. The needle 106 has an adjustable needle position between a drainage position for fluidically connecting the drainage conduit 228 to the needle conduit 106c to drain fluid from the subretinal space of the eye, and an injection position for fluidically connecting the injection conduit to the needle conduit for injecting treatment fluid into the SCS of the eye. When the needle is in the injection position (as shown in Figure 2A), the circumferential opening 224 (e.g., pore) is positioned to coincide with the injection conduit 228. When the needle is in the drainage position, the needle 106 is advanced so that the tip of the needle 106 extends further away from / beyond the distal end 103 of the probe 201, thereby advancing the position of the circumferential opening 224, which is then positioned to coincide with the drainage conduit 228. Therefore, the elements that move the opening 224 and the needle 106 can act as adjustable couplings between fluidly connecting the discharge conduit to the needle conduit and fluidly connecting the injection conduit to the needle conduit.

[0096] The position of the needle 106 is controlled by the needle actuator 108, as previously described for the probe 101. In the embodiment of Figure 2A, the needle actuator 108 is connected to a slider mechanism 220 or other suitable mechanism to advance or retract the tip / end of the needle 106. Alternatively, a rotary dial may be used instead of the slider 220. In either case, a gear assembly may be used such that larger movements of the slider or dial are converted into smaller movements of the extendable needle 106, thereby allowing the user to have finer control over the movement of the needle 106, or vice versa. The needle 106 is also located within a sleeve 206, which constrains the movement of the needle 106 to be linear as it extends and retracts outside the distal end of the probe 201. For example, when the needle position is in the injection position, the tip of the needle 106 may extend (as previously described) about 0.3 mm to about 1.5 mm for the first SCS injection, or about 1 mm to about 2 mm for the second SCS injection. For example, the needle actuator 108 may be implemented to move in incremental steps corresponding to incremental changes in the depth of the needle tip 106 into the patient's eye. These steps may include, but are not limited to, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, and 1.5 mm, or other appropriate distances.

[0097] However, for probe 201, the needle position can be changed to a drainage position, in which case the tip of needle 106 can extend approximately 1.5 mm to 3 mm away from / beyond the distal end of probe 201 to reach a subretinal position in the patient's eye. The needle depth used for drainage depends on the drainage site (for example, the drainage site may vary depending on the thickness of certain ocular tissue layers such as the sclera, and these thicknesses may vary from person to person). However, if the retina shows a more bulging detachment, the tip of needle 106 may be advanced a little further. On the other hand, if the retina has a shallow detachment, a shorter needle protrusion length may be used for drainage. The length of the needle can be changed in fine increments, such as 0.1 mm, for example, but not limited to these, so that the needle can be slowly extended or retracted as described above. For example, the needle tip may be slowly advanced until it passes through the retinal pigment epithelium and enters the subretinal space, and as drainage nears completion and the height of the retinal detachment decreases, needle 106 may be retracted to avoid touching the retina. Fluid discharge can be passive (in which case the fluid at higher pressure in the eye flows naturally into the discharge conduit at lower pressure) or active, in which case suction is used. For example, a fluid actuator 112 and a pump may be coupled to a discharge conduit 228 via port 210 and actuated in the reverse direction, so that instead of applying injection pressure, the fluid actuator 112 applies discharge pressure, which is negative pressure (e.g., suction). In at least one embodiment, a control unit 250 may be used instead to perform active discharge. Thus, in various embodiments, a pump is provided that is fluidically coupled to one or more probe conduits, and this pump can be controlled to generate injection pressure when fluid is injected into the eye or discharge pressure when fluid is discharged from the eye.

[0098] The inventors also found that, in order to achieve good results when repairing an eye with retinal detachment or retinal tear, it may be necessary in some cases to drain fluid from the eye. This fluid drainage may be for fluid in the subretinal space (to a depth of approximately 1.5 mm to 3 mm). The needle position may then be changed to an injection position, where the needle 106 is retracted to a shorter length (i.e., a shallower depth into the patient's eye) to then inject the treatment fluid into the SCS. This may be performed as a two-step procedure, in which case different positions may exist for draining the fluid from the eye (from the subretinal space) and injecting the treatment fluid (into the SCS), although in some cases this drainage and injection may be performed at the same location where the retinal tear is located. However, in some cases, draining near a larger retinal tear is undesirable because it may result in draining vitreous fluid instead of subretinal fluid. In the case of a larger tear, the user may choose a different position to drain the downstream retina, particularly where the retina is more bulging and detached.

[0099] The probe 201 includes a port 222 for receiving part of a guide tool to help the user properly position the tip of the needle 106 when performing drainage or injection. The guide tool is similar to the one described above for device 100. Thus, if the guide tool includes a light source, the port 222 may receive an optical fiber that can be used to couple to an internal optical fiber 109 to illuminate the tip of the needle 106 during use. Alternatively, the port 222 may be used to connect to an OCT imaging system (or any of the other imaging systems described above) if the guide tool includes an OCT imaging system (or any of the other imaging systems described above). Alternatively, the guide tool may be an ultrasound imaging device, in which case the port 222 may be used to couple wires from the ultrasound imaging device to internal wires that connect to an ultrasound transducer located at the distal end of the probe 201, as described for probe 101.

[0100] Referring here to Figures 2B and 2C, shown are a front view of an example embodiment of the control unit 250 and a block diagram of the electrical components of the control unit 250, respectively, where the control unit 250 may be used with any of the probe embodiments described herein to assist the user when performing ST techniques or other ophthalmic procedures / treatments. For example, the control unit 250 may be used with the probe 201, and together they form an embodiment of an ophthalmic treatment device. Alternatively, the control unit 250 may be used with the probe 101 when the control unit 250 operates only in infusion mode. The control unit 250 may be used to perform certain functions, including but not limited to any combination of, for example, controlling drainage, controlling infusion, indicating specific operating parameters to the user, displaying visual guidance to the user using a guide tool, and providing feedback prompts to the user. In at least one embodiment, the control unit 250 may be used to control needle insertion / retraction by processing any combination of sensor signals and image data, thereby extending the needle to a desired injection position and retracting the needle as needed during the procedure. The control unit 250 is connected to an actuator control input 262, such as a pedal, switch, slider, or rotary dial, which the user can use to inject or evacuate while keeping at least one hand free to hold the probe 201 in the correct position. Note that the control unit 250 may be used in conjunction with the probe 101. In that case, when the probe 101 is not performing an evacuation, the components related to evacuation shown in Figures 2B and 2C are not required. Note that the components on the control unit 250 and their positions are shown as examples only and may differ in other embodiments.

[0101] The control unit 250 includes an on / off button 252, an injection operation button 254, and an aspiration operation button 256. In other embodiments, these buttons may be implemented using a single switch having injection and discharge positions, separate switches for selecting injection and discharge modes, or other suitable input / control elements. The user may press the on / off button 252 to switch the control unit 250 from off to on, or from on to off. The user may use the injection operation button 254 to switch the control unit 250 to injection operation mode in order to inject the treatment fluid into the patient's eye via probe 201 or 101. The user may use the aspiration operation button 256 to switch the control unit 250 to aspiration operation mode in order to discharge the fluid from the patient's eye via probe 201.

[0102] The control unit 250 also includes an injection port 258 for receiving an external injection tube connected to an injection conduit 104 of probe 101 or 201. Inside the injection port 258 is connected to an internal injection conduit (e.g., an internal tube) and to a pump 280 used to generate injection pressure during injection. The pump is fluidically coupled to a treatment fluid source to deliver treatment fluid to the injection port 258 via the internal injection conduit. The control unit 250 also includes a discharge port 260 for receiving an external suction tube connected to a discharge conduit 228 of probe 201. Inside the port 260 is connected to an internal discharge conduit (e.g., an internal discharge tube), which is connected to the same pump 280 or a different pump used to generate suction pressure during discharge. The pump 280 is actuated in response to the user engaging an actuator control input 262 to the ON position. The pump 280 is fluidically coupled to a discharge container (e.g., a discharge fluid container) which receives the fluid discharged during use.

[0103] When the actuator control input 262 is engaged, an actuator control signal is transmitted, which is received by the processor 270 of the control unit 250, which then generates a pump control signal to operate the pump 280 according to the infusion mode or suction mode. In infusion mode, the processor 270 is configured to send a pump control signal to the pump 280 to generate an infusion pressure at a predefined infusion pressure level in order to move the treatment fluid from the treatment fluid source to the SCS of the patient's eye. For example, the predefined infusion pressure may be in the range of approximately 20 mmHg to approximately 80 mmHg, such as 50 mmHg. In drainage mode, the processor 270 is configured to send a pump control signal to the pump 280 to generate a suction pressure at a predefined suction pressure level in order to move the drainage fluid from the patient's eye to the drainage container. For example, the suction pressure may be pre-set to be in the range of approximately 0 mmHg to 700 mmHg, or in the range of approximately 100 mmHg to 650 mmHg.

[0104] The control unit 250 may include a display 264 for displaying / showing various information to the user. For example, the display 264 may be used to display the insertion resistance measured during operation, the injection pressure used in injection mode, and the suction pressure used in suction mode. Depending on the embodiment of the probe described herein, other measurements performed during operation, such as the light intensity, light wavelength, and / or light polarization of any light reflected from the eye into the probe and measured, may be displayed. In the case of the measured injection resistance, there may be wires / cables connecting the resistance sensor in the probes 101, 201 to an interface in the control unit 250 accessible by the processor 270. Alternatively, in at least one embodiment, the connection between the probe and the control unit 250 may be wireless. In at least one embodiment, the display 264 may be a touch-sensitive screen that can be used by the user to operate the control unit 250, in which case the injection operation button 254 and the suction operation button 256 may be omitted, as the user can select these modes by touching the display 264.

[0105] In at least one embodiment, if a guide tool such as a light guide, OCT imaging, and / or US imaging is used, the control unit 250 may include a guide tool port 266. In the case of a light guide, port 266 may be used to accept an external optical fiber connected to probe 101 or 201, and internally port 266 is connected to an internal light source. In the case of OCT imaging, or other optical imaging devices previously described, port 266 may be used to accept an external optical fiber connected to probe 101 or 201, and further port 266 is internally connected to an OCT device (or other optical imaging device previously described), which may be located inside or outside the control unit 250. In the case of US imaging, port 266 may be used to accept an electrical cable that ultimately connects to a US transducer in probe 101 or 201, and internally port 266 is connected to a US imaging device, which may be located inside or outside the control unit 250. If the guide tool is an OCT device or a US imaging device and it is included in the control unit 250, the resulting OCT or US image may be output on the display 264.

[0106] If the guide tool is a light guide and the display 264 is a touch-sensitive display, the user may be able to adjust the intensity or wavelength of the light produced by the light source. Alternatively, in embodiments where the display 264 is not touch-sensitive, a physical slider control (not shown) may be used for the same purpose. The light source may be an LED that produces white light, and an LED driver may be used to control the intensity of the white light beam produced. The light intensity may be controlled via a calibration setting and / or via user control during use. In at least one embodiment, the light source may include an LED capable of producing a colored light beam as described above. In at least one embodiment, the light source may include two LEDs having two LED drivers, one of which produces white light and the other produces colored light. An optical system may be used so that the colored light beam is smaller and positioned within the white light beam.

[0107] In at least one embodiment, the control unit 250 may include a speaker 268 which can be used to output audio indicating one or more operating parameters and / or operating modes of the control unit 250. Thus, when the user selects an injection mode or an suction mode, audio indicating that the control unit 250 is operating in either the injection mode or the suction mode, respectively, may be output through the speaker 268. Furthermore, any of the measured injection resistance, injection pressure, and suction pressure may also be indicated in the audio output through the speaker 268. Outputting the measured insertion resistance may be done when the measured insertion resistance changes by a certain amount, for example, between 10% and 20%, while the user is inserting the needle 106. Alternatively, other sounds, such as a tone or beep, may be communicated to the user depending on the operating conditions, such as when the needle tip is penetrating too deeply or when it has reached its intended target position based on any of the sensing techniques described herein.

[0108] Referring again to Figure 2C, which shows a block diagram of an example embodiment of the components of the control unit 250 shown in Figure 2B. The control unit 250 includes a processor 270, a memory unit 272, a user interface 274, a device interface 276, one or more sensors 278, a display 264, one or more pumps 280, a speaker 268, an optional light source 282, an optional OCT device 284, an optional US device 286, and a power supply unit 287. The memory unit 272 includes random access memory ("RAM") and non-volatile storage configured to store program / software instructions for the operating system 288, programs 290, control applications 292, I / O modules 294, and files 296. The components and their configurations shown in Figure 2C are examples and may differ in other embodiments. The power supply unit 287 provides power to the various components of the control unit 250.

[0109] The processor 270 controls the operation of the control unit 250 and may include any suitable processor, controller, or digital signal processor capable of providing sufficient processing power depending on the configuration, purpose, and requirements of the control unit 250, as is known to those skilled in the art. For example, the processor 270 may include a high-performance general-purpose processor. In an alternative embodiment, the processor 270 may include multiple processors, each configured to perform a different dedicated task. In an alternative embodiment, dedicated hardware may be used to provide some of the functionality provided by the processor 270.

[0110] Display 264 can be any suitable display device that outputs visual information. For example, display 106 can be an LCD or LED or a touchscreen. Depending on the components / functionality of the control unit 250, display 264 can provide notifications and display measured values, operating parameters and / or guide images. For example, processor 270 may be configured to display operating parameters such as measured resistance, injection pressure and / or suction pressure on display 264.

[0111] The user interface 274 allows the user to provide input to the control unit 250 via one or more input devices, which may include, but are not limited to, an on / off button 252, an injection operation button 254, and a suction button 256. In some cases, the input device may be a slider, button, lever, dial, or thumbwheel, and if the control unit 250 includes a light source used for visual guidance, the input device may be used to adjust the light intensity.

[0112] The device interface 276 may include a communication port, a networking interface device, an analog-to-digital converter (ADC), or a digital-to-analog converter (DAC), and the communication port may include any combination of at least one serial port, at least one parallel port, and at least one USB port providing USB connectivity. The device interface 276 is used to connect the processor 270 to various devices in a communicative manner, thereby enabling the processor 270 to send and receive signals with other devices that may be inside or outside the control unit 250, such as one or more sensors 278 or actuator control inputs 262. Thus, the device interface 276 may be adapted to receive measurement data and transmit control signals for the operation of the device.

[0113] In at least one embodiment, the control unit 250 may include a communication unit which may include a radio for wireless communication using CDMA, GSM, GPRS, or Bluetooth protocols, or other wireless communication protocols, and in accordance with standards such as IEEE 802.11a, 802.11b, 802.11g, or 802.11n. The communication unit can be used by the control unit 250 to communicate with other devices, computers, or probe embodiments that have a corresponding radio. Thus, the communication unit can provide the control unit 250 with a means to communicate wirelessly with various devices that may be remote from the control unit 250.

[0114] For example, one or more sensors 278 may include a resistance sensor 107 such that the measured resistance value is received via an ADC and analyzed by the processor 270. Similarly, the actuator control input 262 may generate an analog signal that is converted by an ADC in the device interface 276 into a digital signal that the processor 270 can receive and process. As another example, the processor 270 may generate a digital pump control signal in response to receiving an actuator control signal, which may be converted into an analog signal via a DAC in the device interface 276 and sent to the pump 280.

[0115] In another example, speaker 268 may be communicably coupled to a processor via a DAC in device interface 276, and processor 270 is configured to generate an audio signal and output the audio signal via speaker 268, where the audio signal includes voice, tone, or beep corresponding to measurement data including operating parameters and / or measured resistance, injection pressure, and / or suction pressure. Alternatively or additionally, in at least one embodiment, a vibrator may be included in control unit 250 and used to communicate certain operating states to the user, such as the position of the tip of a needle relative to a desired position in the eye, as described above.

[0116] In another example, in an embodiment in which the control unit 250 includes a light source (various implementations of the light source have been described above), the device interface 276 may include a light port coupled to the light source 282 via an internal optical conduit (e.g., optical fiber). This allows the light source 282 to be coupled to an external optical fiber connected to the light port and probe 101 or 201.

[0117] In another example, in an embodiment where the control unit 250 includes an OCT device 284 or other optical imaging device as described above, the device interface 276 may include a light port for receiving an optical fiber optically coupled to an optical conduit in the probe 101 or 201, and the control unit 250 may include an internal optical conduit optically coupled to the light port and the OCT device 284 or other optical imaging device. In such an embodiment, OCT measurements produced by the OCT device 284, or images produced by the other optical imaging device, may be output on the display 264 under the control of the processor 270.

[0118] In another example, in an embodiment where the control unit 250 includes a US imaging device 286 and the probe 101 or 201 includes a US transducer positioned at the distal end of the probe 101 or 201, the device interface 276 may include an electrical port for receiving an electrical cable used to connect to the US transducer and transmit the US signal generated by the US transducer. The port is connected to an internal wire that connects to the US imaging device, which receives the US signal and processes the received ultrasonic US signal to generate a US image. In such an embodiment, the US image generated by the US device 286 may be output on a display 264 under the control of a processor 270. Alternatively or additionally, the control unit 250 may include a transducer for generating an acoustic signal, and / or an acoustic reflection measurement device for receiving, processing, and displaying the processed acoustic reflection measurements on a display 264, the device interface 276 may include an acoustic port for coupling the acoustic signal, and the probe 101 or 201 may include one or more acoustic waveguides.

[0119] As is known to those skilled in the art, the power supply unit 287 may be a power adapter or a rechargeable battery pack, depending on the implementation of the control unit 250. In some cases, the power supply unit 287 may include a surge protector connected to the main power line and a power converter (neither shown) connected to the surge protector. The surge protector protects the power supply unit 287 from any voltage or current spikes in the main power line, and the power converter converts the power to a lower level suitable for use by the various elements of the control unit 250. In other embodiments, as is known to those skilled in the art, the power supply unit 287 may include other components for providing power or backup power.

[0120] The memory unit 272 includes volatile and non-volatile storage, such as ROM, one or more hard drives, one or more flash drives, and / or several other suitable data storage elements. Non-volatile storage may be used to store software instructions, including computer executable instructions for implementing the operating system 288, program 290, control application 292, and other software modules, as well as any data used by these software modules. The operating system 288 and program 290 may include software instructions for performing the basic operations and functions of the processor 270 and the control unit 250. Data may be stored in file 296 as data relating to the operating parameters of the control unit 250, and data such as any images when the OCT device 284 or US imaging device 286 is used. The control application 292 includes software instructions for providing various functions of the control unit 250 as described herein. The processor 270 is configured to perform these functions when executing the software instructions of the control application 292. The I / O (input / output) module 294 includes software instructions that, when executed by the processor 270, can configure the processor 270 to store data in file 296 and / or read data from file 296.

[0121] In at least one embodiment, in one application, the distal end of probe 101 or 201 may be positioned posterior to the macular region and may be used to place a choroidal (and / or macular) buckle to treat myopic macular holes and / or myopic traction maculopathy. However, this may require a conjunctival incision to access this region. For example, the conjunctival incision may be performed in the inferior temporal quadrant of the eye under local anesthesia. The intermuscular septum may also be minimally dissected. One of the probes described herein may then be passed posteriorly into the macular region. Once it is internally visualized that the probe is pushing down the macular region, a treatment fluid may be injected into the suprachoroidal space to form a temporary choroidal buckle in this region. In at least one embodiment, one of the probes described herein may be used to deliver certain treatments, such as gene therapy or other drug solutions or drugs on a sustained-release platform / hydrogel, into the subretinal space in the macular region.

[0122] In at least one embodiment, any of the devices described herein may be used alone in a clinic or operating room (OR), or in combination with a) vitrectomy, b) with a chandelier for visualization and subsequent placement of a choroidal buckle, c) to complement the action of a gas bubble or to address inferior tears or holes that cannot be adequately addressed by the gas bubble due to patient positioning limitations, in combination with pneumatic retinal reattachment (in a clinic or operating room), and / or d) in combination with a conventional scleral buckling, in which case the ST procedure may be added simultaneously with, or later as an adjunct to an already placed scleral buckle, or as a rescue procedure if the primary scleral buckle is not functioning. The procedure may also be used as an adjunct to vitrectomy when iatrogenic retinal tears occur.

[0123] In at least one embodiment, the injection conduit 104 of probe 101 or 201 may be filled with liquid nitrogen to perform cryotherapy to repair the retinal tear / detachment. Alternatively, an additional injection conduit may be added to probe 101 or 201 and used for cryotherapy, while the other injection conduit may be used for injecting the treatment fluid. Currently, without cryotherapy, if the retina reattaches following injection of the treatment fluid into the SCS, the patient will subsequently require laser retinal photocoagulation within a few days, which will create permanent chorioretinal adhesion between the retina and the retinal pigment epithelium around the retinal tear. Alternatively, in a probe that includes cryotherapy, the probe may be used to perform cryotherapy first, then subretinal fluid drainage if necessary, and then injection of the treatment fluid into the SCS. This may have the advantage that the patient may not need anything further to treat the retinal detachment, and thus advantageously, the procedure requires only one session without follow-up sessions for further treatment.

[0124] In at least one embodiment, the injection conduit 104 of the probe 101 or 201 may contain an inert gas or air that can be injected into the vitreous humor by extending the needle into the vitreous humor. Alternatively, an additional injection conduit may be added to the probe 101 or 201 and used for intravitreal injection. Thus, the same probe may be used in combination with the ST method and gas retinal repositioning. For example, intravitreal injection may be performed about 4 mm posterior to the limbus, where the ciliary body flattening is located and where intravitreal injection is safe.

[0125] Currently, conventional devices for suprachoroidal (or subretinal) drug delivery heavily rely on scleral incision, followed by traversing the suprachoroidal space to the desired target site, and then initiating injection into the suprachoroidal (or subretinal) space. Some of these devices rely on drug injection into the anterior suprachoroidal space, from which the drug is expected to dissipate or diffuse to the target site. However, none of the conventional devices allow for direct scleral penetration at the posterior target site, nor do they have a needle that can be retracted while the device is positioned and then extended variably (and controllably) to the desired depth. One problem that prevents direct scleral penetration is that, in the typical design of conventional devices, the needle extends from the distal end of the device, typically along the longitudinal axis (i.e., parallel to the longitudinal axis) of the distal probe end, making it difficult to orient the conventional probe to the correct position and angle (e.g., approximately vertical or any desired angle) for proper scleral penetration.

[0126] However, this challenge is overcome by various embodiments of probes described herein in accordance with the teachings, in a first embodiment, the side surface of the distal end of the probe is preferably curved, having a radius of curvature similar to that of the eye (e.g., the sclera) into which the needle is inserted. Since the target position for insertion can be in different parts of the eyeball, the distal curvature can have different arc angles and radii of curvature, so that the needle, emerging from the exit position of the curved side surface of the distal end of the probe positioned adjacent to the outer surface of the eye, is inserted into the sclera at approximately 90 degrees, thereby enabling precise positioning of the target insertion site. For example, for more anterior target positions in the vitreous base or equator, such as for retinal detachment repair or drug delivery, a shorter probe distal end length and a corresponding arc angle of, for example, about 10 to about 15 degrees are required (or a probe with a larger or smaller distal end, in which case a longer or shorter distal end may be used). However, for drug delivery to more posterior areas, such as near the macula, a larger arc angle of approximately 60 to 75 degrees may be preferable at the distal curved portion of the probe, which allows for proper positioning of the device on the scleral surface.

[0127] In a second embodiment, the distal end of a probe described herein according to the teachings may have a shape substantially flat with respect to the surface of the distal probe end from which the needle extends, so that the probe surface is tangential to the scleral surface at the needle insertion point.

[0128] In a third embodiment, the needle at the distal tip of the probe described herein according to the teachings may extend substantially perpendicular to the longitudinal axis of the distal end from a position on the side of the distal end of the device, thereby allowing the needle to be inserted substantially perpendicular to the scleral surface. For example, the needle may extend from a position on the curved surface of the distal end of the probe, or from the tip of the probe. In either case, the needle may extend from the curved surface of the distal end of the probe facing the eye, thereby allowing the curved surface of the distal end of the probe to be positioned along the curvature of the eye, and the needle may be inserted into the sclera perpendicular to the tangent to the eyeball at that position. Advantageously, this reduces / minimizes the distance the needle must travel to reach a desired target position within the eye, thereby reducing the risk of complications such as bleeding. Furthermore, the predictable, straight path followed by the extended needle, which is perpendicular to the tangent to the eyeball, allows for more predictable needle penetration depth, thereby favorably increasing the likelihood that the needle tip is in the correct position and depth (e.g., subretinal or suprachoroidal space, depending on the ophthalmic procedure being performed).

[0129] In some embodiments, the probe and needle may be configured such that the needle is inserted into the sclera at an angle that is not nearly perpendicular to the sclera at the point of entry. Such a configuration may be preferable in some cases because it allows the needle tip to enter the SCS at an angle, resulting in the needle traveling a longer distance before crossing the SCS and thus reducing the likelihood of accidentally penetrating the choroid by crossing the SCS.

[0130] In at least one embodiment, the three embodiments described above are combined with one or more previously described sensing mechanisms to enable accurate and precise localization of the needle tip at a desired target location from a position outside the sclera. Furthermore, sensing mechanisms such as, but not limited to, a light beam and / or a resistance sensor (which may be implemented using a pressure sensor, flow sensor and / or impedance sensor) are also directed relative to the sclera surface from the side of the distal end of the probe in the same direction as the needle.

[0131] Referring here to Figure 3A, in accordance with the teachings of this specification, several embodiments of the distal ends of probes 300a, 300b, and 300c are shown, having different arc angles and arc lengths of the curved distal ends for positioning at different locations on the eye. Each of the probes 300a to 300c has distal ends 302a to 302c, which are curved such that the lower surfaces 304a to 304c of the probes 300a to 300c (i.e., the probe surface facing the sclera during use) have a radius of curvature corresponding to the region of the eye where the entry point must be precisely determined, thereby positioning the curved distal end to conform to the scleral surface, with different angles between the first longitudinal axis of the probe body and the approximate second longitudinal axis of the curved distal end, and optionally, different lengths of the curved distal end for reaching different scleral positions. For example, the radius of curvature of the distal ends of different probe embodiments may be approximately the same as the radius of curvature of the human sclera. For example, each probe has a radius of curvature of approximately 10 mm to 15 mm at its distal curved portion. Using probe 300a, this curved portion is the lower surface of the distal curved portion indicated by reference no. 304a. The arc length is the length of the arc-shaped portion at the distal end and is indicated as 304L. The arc angle is the angle indicated as Beta. The dashed sector is for illustrative purposes only and illustrates the characteristics of the arc angle and arc length at the distal end of the probe. The arc angle of the distal curved end portion may be approximately 60 degrees for probe 300a, approximately 30 degrees for probe 300b, and approximately 15 degrees for probe 300c. Using probe 300a, the longitudinal axis A1 of the probe body and the longitudinal axis A2 of the distal curved end portion have an angle α (as shown in Figure 3A), which indicates how the end portion curves away from the longitudinal axis of the probe body.

[0132] It should be noted that the surface of the distal end of the probe that faces the eye during normal operation and from which the needle protrudes may be referred to herein as the inner surface, bottom surface, concave surface, lateral surface, or any similar term.

[0133] As described above, the probes 300a-300c and the curved distal ends 302a-302c have different arc lengths to allow the needle to be positioned in different target areas on the eyeball. Thus, the distal ends have a predetermined radius of curvature and length to access the desired position on the ocular surface when in use. For example, a distal tip portion with an arc angle of about 10-20 degrees may be used for anterior positions of the eye, while an arc angle of 20-40 degrees may be used for intermediate peripheral positions, and an arc angle of about 50-70 degrees may be used for more posterior areas such as the macula.

[0134] Referring here to Figure 3B, which is an enlarged view of probe 300a, it should also be noted that each probe 300a-300c may have bosses 308a-308c on the underside of the distal end from which the needle extends. One or more sensing elements that can be used may be directed from the boss to the scleral surface for various purposes, such as precise depth determination during use. For example, a guide light beam may be emitted from the boss (see, for example, 463 in Figure 4E). Alternatively, there may be embodiments in which the boss is not used, but the needle and one or more sensing elements are positioned similarly on the underside of the probe. The bosses 308a-308c, also called projections, mounds, or nub, may be used to press against the sclera when locating the target injection area, so that the probes 300a-300c can be precisely positioned over the area of ​​the scleral surface of the eye from which the injection is performed. However, if the boss is not used, pressing against the ocular surface may still occur. During use, depending on the embodiment, the needle may extend from the boss or from a position adjacent to the boss. Therefore, the probe may have a boss on its side at the exit position, through which the needle extends and retracts, or it may have a boss adjacent to the exit position on its side, with the needle extending and retracting adjacent to the boss. Note that any probe described herein may, in various embodiments, have the shapes of probes 300a to 300c shown in Figures 3A to 3B. Therefore, the boss can be used as a visual indicator to show where the needle extends from. The dimensions of the nub may be selected to accommodate the dimensions of the needle used. For example, if a 30G needle is used, the boss may have a diameter of approximately 0.5 to 1.5 mm.

[0135] In at least one embodiment, a force sensor may be provided within the boss so as to provide the user with force feedback on how much force the user is applying to the scleral surface when extending the needle into the eye. This force feedback can be used by the user to avoid applying excessive force during needle extension, which would otherwise press on the sclera and result in a penetration depth greater than desired.

[0136] In at least one embodiment, the boss may be used to provide more space for accommodating a needle and one or more sensors without changing the overall thickness of the distal end of the probe.

[0137] In at least one embodiment, the boss may be movable or vibrate during use, which may be used to help determine the position of the distal end of the probe and where the needle extends from the probe during use. For example, the boss may be moved in a reciprocating / vibrating manner at a certain frequency (e.g., rhythmically), and this movement may be visible inside the eye, thereby assisting in the visualization and identification of the position of the curved distal end of the probe.

[0138] In at least one embodiment, the amount by which the boss protrudes from the distal portion of the probe, or the position of the boss, may be adjustable by mechanical, electrical, or pneumatic means. In a first position, the boss may be flush with the underside of the distal end of the probe, or retract from this surface, so that the boss does not come into contact with the eye or apply pressure to the eye, even when the probe is in contact with the eye, which may be preferable as the probe is advanced along the outer surface of the eye toward a desired position. To allow the user to better visualize the position of the probe, the boss may be adjusted to sometimes protrude from the underside of the distal end of the probe and apply pressure to the eye, creating an additional indentation that can be seen by the operator from outside the eye by observation with an ophthalmoscope or other means (in addition to the indentation created by the underside of the distal portion of the probe in contact with the eye / sclera). In at least one embodiment, the boss may protrude more or less, creating a larger or smaller indentation, which may be done as needed to facilitate observation.

[0139] In any embodiment of the probes described herein, the curved distal end portion may be rigid. Alternatively, in at least one embodiment, the probe may have a flexible portion proximal to the distal end that is adjustable to adjust the angle between the longitudinal axis of the distal end and the longitudinal axis of the body. In such embodiments, the angle may be adjustable in the range of about 15 degrees to about 60 degrees.

[0140] In another alternative form, any embodiment described herein may be modified so that the curved distal end portion is retractable relative to the body of the probe. This can help reach the appropriate posterior position of the eye when performing ophthalmic procedures. For example, using probe 300b as an example, the length L1 of the curved distal end portion may be increased by using a retractable arm extending from approximately position T in Figure 3A. In at least one case, an engaged locking mechanism may be present to prevent accidental retraction during use.

[0141] Furthermore, any embodiment described herein may be modified so that the curved distal end portion is sufficiently flexible, thereby changing the radius of curvature of the curved distal end portion to better conform to the surface of the eye (e.g., the sclera) during ophthalmic procedures. For example, taking probe 300b as an example, the radius of curvature of the lower surface of the distal end of the probe, indicated by reference numeral 304b, may be slightly changed by bending the distal end of probe 300b.

[0142] Referring here to Figures 3C-3D (dimensions are not to scale), examples of the placement of the distal ends of different probes 310 and 320 at different locations on the scleral surface of the eye are shown. In Figure 3B, probe 310 has a boss 312, which, along with one or more sensing mechanisms described herein, allows for precise positioning and penetration depth of a needle 314 extending almost perpendicularly into the sclera from the distal end of probe 310, into which treatment fluid is injected to form a bleb (e.g., a viscoelastic bleb in this example) within the SCS, forming a choroidal buckle. However, the boss may also be optional without affecting the accuracy of the procedure when using the probe. In Figure 3C, probe 320 also has a boss 322, which may be optional, but a longer probe is used that has an angle between the longitudinal axis of the probe body and the longitudinal axis of the curved distal end portion, and that can reach further posteriorly along the posterior surface of the eye, so that treatment fluid can be injected into the SCS or subretinal region depending on the ophthalmic procedure being performed. In each of these cases, during the procedure, the indentation on the scleral surface of the eye is observed through one of the visualization techniques described herein, and the distal curved portion of the probe and the needle are appropriately positioned to press against the scleral surface of the eye before the needle extends and begins to advance into the eye.

[0143] As shown in Figures 3C and 3D, the distal end of the probe is angled and has a radius of curvature that conforms to the eye (e.g., the scleral surface). The probe can be positioned directly on the conjunctiva, as far posterior as possible, based on the conjunctival fornix. For more posterior positions, a small conjunctival incision may be required. Once the probe is positioned on the scleral surface at the desired location, the surgeon can lightly press with the device, and the indentation formed by the distal portion of the probe (boss or plate portion, depending on the embodiment) is visible from the inside. The needle exit site (e.g., exit position) can be identified by evaluating the midpoint of the indentation (since the needle exit site is located in the center of the distal portion of the probe). Thus, the surgeon can position the internal target location at the midpoint of the indentation to properly center the choroidal bleb. This procedure can be performed under local anesthesia, subconjunctival anesthesia, sub-Tenon's capsule anesthesia, or retrobulbar anesthesia. In most cases, local or subconjunctival anesthesia is sufficient. The appropriately curved distal portion of the probe, along with the needle extending perpendicularly from its inner surface, allows the surgeon to reach various target areas on the conjunctival or scleral surface without being obstructed by the orbit and periorbital tissues, thereby enabling the needle to penetrate the conjunctiva and / or sclera at the correct angle. While this description may state that the probe contacts the scleral surface, without a conjunctival incision, the underside of the probe may contact the conjunctival surface (which is the episclera and the thin mucosa covering the sclera). Furthermore, as previously described, the guide light beam 324 may be used to assist in the proper positioning and insertion depth of the extended needle. For example, the guide light beam may be used for illumination or to indicate when the tip of the needle 106 penetrates different layers of the eye based on the determination of changes in transmitted or reflected light.

[0144] In at least one embodiment, the first safety mechanism is included in any of the probes described herein by including a sensor at the distal end of the probe in contact with the eye that is used to sense how much force the user is applying. Feedback on the amount of this force may then be provided to the user so that the user knows not to apply excessive force, which could result in the needle penetrating too deeply into the eye, as well as injecting or removing fluid from the wrong location within the eye. Applying excessive force can also lead to other undesirable consequences, such as bleeding or retinal tears. Any suitable force sensor having sufficient sensitivity to measure the force and / or pressure at the eye-contacting portion of the probe may be used. If the measured amount of force is greater than a force threshold (indicating that the needle may begin to penetrate too deeply into the eye), the user may be provided with, for example, acoustic feedback, voice feedback, or other suitable form to notify the user not to press any harder.

[0145] In at least one embodiment, a second safety mechanism is included in any of the probes described herein to protect against excessive force being applied to the patient's eye from the distal end of the probe. Referring here to Figure 3E, an exemplary embodiment of a portion of a probe 330 comprising a pressure distribution flange 332 is shown. The pressure distribution flange 332 may be implemented using a dish-shaped medical hemisphere or membrane, and acts as a guard, positioned on the underside of the probe 330 in contact with the scleral surface of the eye. The shape of the surface of the flange 332 in contact with the scleral surface of the eye may be concave and may have a radius of curvature that conforms to the shape of the eye (e.g., the scleral surface) at the location where the needle is inserted. The flange 332 may be offered in different sizes and / or different degrees of concavity to accommodate different eye sizes. The flange 332 may be a separate component attached to the probe 330 (e.g., by a snap-fit ​​connection) or it may be integral with the probe 330 and be part of it. Preferably, the flange 332 is positioned such that the needle 334 extends from an approximate central position on the flange 332. In embodiments including a guide light beam, the flange 332 may be made of a material transparent to the wavelength of light that can be used for the guide light beam, or it may have an opening through which the guide light beam is irradiated during use, so that the guide light beam is irradiated through the flange 332 with little attenuation. The flange 332 may be positioned adjacent to and above the boss 336 so that the flange 332 is positioned between the boss 336 and the scleral surface of the eye during use. However, in embodiments without a boss, the flange 332 is positioned directly on the underside of the distal end of the probe.

[0146] In at least one embodiment, the flange 332 (which may also be called a guard) may change shape if the user applies excessive force. This force, if the flange 332 is not used, would cause the needle tip to extend deeper than the desired depth, preventing the treatment fluid from being injected in the correct location. Thus, if the positioning is correct and the sclera is compressed, this feature of the flange 332 can help maintain the force at a relatively constant level while the needle 334 is subsequently extended, otherwise the needle may advance excessively deep. In at least one embodiment, the change in shape of the flange 332 can be used as a visual cue to inform the user to apply a smaller amount of force. Alternatively or additionally, the flange 332 may be shaped so that the force applied by the user is distributed across the surface of the flange 332. This protects against excessive force that would otherwise be concentrated on the boss 336 (if used) or the probe surface around the base of the needle 334. This excessive force would compress the sclera as the needle 334 is extended, causing the needle 334 to penetrate deeper than intended. Furthermore, the flange 332 may be dimensionally designed to tolerate small compressions but prevent greater compressions caused by excessive force that could lead to excessive penetration depth into the eye. The flange is also preferably sized so as not to obstruct the user's field of vision. In at least one embodiment, the same flange can be used to compress the eyeball and replace the function of the boss 336, thereby eliminating the need for the boss 336.

[0147] In at least one embodiment, a third safety mechanism is included in any probe described herein to prevent excessive force being applied so that the needle tip extends excessively deep into the patient's eye. The third safety mechanism may be used alone or in combination with the first and / or second safety mechanisms. For example, the third safety mechanism includes a depth limiter, such as a post or annular disc, which is located within the distal portion of the probe, and as a result, the needle cannot extend beyond the surface of the distal end of the probe that contacts the scleral surface beyond a depth limit that may range from about 0.5 mm to about 1.5 mm (which may vary depending on the particular eye, for example, due to differences in scleral thickness) and from about 1 mm to about 3 mm depending on the injection location and function (e.g., first injection, second injection, or drainage).

[0148] In at least one embodiment, any of the probes described herein includes a fourth safety mechanism to protect against excessive force being applied to the patient's eye from the distal end of the probe. Referring here to Figure 3F, an exemplary embodiment of a portion of the probe 340 including a variable coupler 342 is shown. The variable coupler 342 is positioned between a boss 336 and a flange 332. In some embodiments having the variable coupler 342 and flange 332, the boss 336 may be optional. Also, in some embodiments with the variable coupler, the flange 332 may be optional, and the variable coupler may be positioned below the boss 336. The variable coupler provides a variable mechanical coupling to avoid situations in which the user applies excessive force and the needle penetrates too deeply. Thus, in at least one embodiment, the device / probe includes a flange and / or a variable coupler at the exit position to maintain position or pressure between the side and the surface of the eye. In at least one embodiment, the variable coupler may include a spring or have a piston that moves within a cylinder to absorb some excess force. In at least one embodiment, the spring may be adjustable, and as a result, the coupling is configured to be rigid during needle insertion but to "soften" once the needle tip reaches a desired depth, thereby preventing further changes in the applied pressure from causing a change in the needle tip position. In at least one embodiment, the variable coupler 342 may be adapted to attenuate the pressure applied to the eye by the distal end of the probe if the pressure or force applied to the eye during use exceeds a threshold. For example, the variable coupler may include a pressure relief valve that releases pressure if the pressure applied to the eye during use exceeds a threshold, or a force damper if the force applied to the eye during use exceeds a threshold.

[0149] Referring here to Figure 3G, a front view of an exemplary embodiment of a pressure distribution flange 350 having one or more sensors 352 is shown (for illustrative purposes only, only one of them is labeled and shown as a dot for simplification). In at least one embodiment, the sensor 352 may be a strain sensor used to detect a change in the curvature of the flange 350, the change in curvature indicating that excessive force is being applied by the user during scleral compression or needle extension, and feedback (e.g., audible or visual) is provided to the user so that the force being applied can be reduced. Alternatively, at least one of the sensors 352 may be a pressure sensor or force sensor, the measurement of which may be compared to a force threshold, and audible or visual feedback may be provided to the user if excessive force is being applied during scleral compression and / or needle extension. In another embodiment, multiple pressure / force sensors are provided uniformly distributed around the flange 350, and if the sensors 352 show nearly identical measurements, this indicates that the flange is perpendicular to the eyeball during scleral compression, resulting in the needle 334 extending nearly perpendicularly into the sclera. On the other hand, if the measured pressure is uneven, it may indicate that the flange is tilted, in which case, when the needle 334 is extended / unfolded, it may not be inserted perpendicularly into the sclera. This may be useful when manually inserting the needle into the eye.

[0150] Referring to Figure 3H, an example embodiment of an ophthalmic device 360 ​​that can be used with an ophthalmic treatment device to achieve precise localization and precise needle penetration depth for ophthalmic procedures is shown. In this exemplary embodiment, the ophthalmic device 360 ​​is entirely housed within the body 102, and as a result, the ophthalmic device 360 ​​also functions as a probe and is a standalone device, without using any external fluid connections (e.g., tubing) or electrical connections. In at least one embodiment, the hardware of the device 360 ​​may be contained in a first part, and the fluid system may be contained in a second part that is releasably connectable to the first part. This allows the second part containing the fluid components to be disposable for single use in a single patient, or to be a partially disposable configuration including sterilizable reusable components. The distal end generally has a curved portion with an arc angle, as described in other embodiments of the probe described herein.

[0151] The standalone ophthalmic device 360 ​​may have a variety of internal structures, and in this example, the ophthalmic device 360 ​​has several components similar to the probe 201, and further includes several components of the control unit 250. All of these similar components operate as described above. Note that in Figure 3H, the elements are not drawn to scale. In at least one alternative embodiment, the boss may be included in the distal curved end portion, as described in other embodiments described herein.

[0152] The ophthalmic device 360 ​​is capable of both infusion and drainage and includes a drainage conduit / tube 228' located on one side of the device 360, while the hardware is located on the other side of the device 360. In an alternative embodiment, the device 360 ​​may include only one conduit, such as conduit 104, which may be used for both infusion and drainage as described herein for other embodiments. Port 210 is also available for connection to a plunger for injecting fluid into the eye (or, if conduit 104 is used for both infusion and drainage, for removing fluid from the eye), if necessary. Otherwise, in a dual conduit embodiment, the drainage conduit 228' is coupled to a drainage port 362, which may be in fluid communication with a drainage device (e.g., a pump). The drainage port 362 may be optional if the fluid portion of the device 360 ​​is to be discarded after use. The device 360 ​​also includes a fluid port 216 for coupling fluid to the infusion conduit 104, into which the fluid will be injected into the eye during use. Alternatively, as described in other embodiments herein, the device 360 ​​may be supplied with a fluid pre-filled or may be able to receive a fluid cartridge.

[0153] In this exemplary embodiment, device 360 ​​includes a microcontroller 362 for controlling the operation of various hardware elements of device 360, and a power supply 364 for supplying power to various components of device 360, such as a microcontroller 364 and an optional motor. The microcontroller 364 also includes a memory device (not shown) for storing program instructions that constitute the microcontroller 364 to perform various functions when the program instructions are executed by the microcontroller 364. The power supply 366 may be rechargeable or a non-rechargeable battery. If device 360 ​​is connected instead to a power outlet or another device that can supply power, the power supply 366 may include surge protection and voltage regulation circuits.

[0154] Device 360 ​​also includes a mode selection input, such as a button or slider, for switching between an injection mode in which fluid is injected into the eye and an exhaust mode in which fluid is discharged from the eye. Device 360 ​​also includes a fluid actuation control input 370, such as a button or slider or similar, which controls an internal fluid actuator (not shown), which may be a motor that pushes / pushes an internal plunger (not shown) in various conduits, to perform injection or discharge. While fluid is being injected or discharged, the fluid actuation input 370 may be pressed and then released to stop injection or discharge, depending on whether injection mode or exhaust mode is selected.

[0155] The device 360 ​​is used to control the extension and retraction of the needle 106 and also includes a needle action control input 372, which may be a slider, rotary dial or other input mechanism, as previously described in other embodiments described herein. The input 372 may be used to gradually extend the needle into the eye, as described herein.

[0156] Device 360 ​​may also include one or more sensors 107, including any combination of pressure sensors, force sensors, and impedance sensors, as previously described. The location of the sensors 107 is shown in Figure 3H for illustrative purposes, and may be located in other locations in other embodiments.

[0157] Device 360 ​​also includes a light source 374 which can be used to generate white light transmitted along the optical fiber 109 and irradiated outward from the underside of the distal end adjacent to the position where the needle 106 protrudes from the underside of the distal end during use. The light source 374 can generate white light or a colored light beam used as a guide light beam as described in other embodiments described herein. The light source 374 may be located at the distal end of device 360 ​​and may be coupled to an injection conduit further distally, and the injection conduit may be used as an optical transmission conduit. In at least one embodiment, mirrors may be used to reflect the laser / light along the length of device 360.

[0158] In at least one embodiment, device 360 ​​may include a radio (not shown) for short-range or long-range wireless communication, thereby providing sensor data collected during operation to another device such as a display or control unit 250 for providing feedback on various parameter values ​​to the user during operation (as described for control unit 250).

[0159] In at least one embodiment, device 360 ​​may include one or more output devices, such as a small display (not shown), such as an LED display, to provide the user with visual feedback of the values ​​of certain parameters during the operation of the device. In at least one embodiment, device 360 ​​may include a speaker and / or a vibrator to provide feedback to the user, as described in the earlier embodiments described herein. In at least one embodiment, the vibrator and / or speaker may be optional.

[0160] In an alternative embodiment, device 360 ​​may be constructed without using any electronic hardware, in which case the device implementation uses mechanical and / or pneumatic elements for control and operation.

[0161] Referring here to Figure 4A, a flowchart of an exemplary embodiment of Method 400 for treating a retinal tear or RRD according to the teachings herein is shown. In step 402 of Method 400, the user sets up the ophthalmic treatment device using probe 101 or 201 or another suitable probe described herein. The setup may include connecting various tubes and wires and loading the treatment fluid.

[0162] Method 400 then proceeds to step 404, in which the user examines a patient with an eye containing a retinal tear or RRD using indirect ophthalmoscopic or wide-field observation in an operating room. For example, the posterior segment of the eye may be visualized using binocular indirect ophthalmoscopic observation. Optical lenses such as a 28D lens or another lens such as a 20D lens may be used. A light source may be mounted on the user's head so that the user can observe the inside of the eye binocularly and as a result the user can obtain three-dimensional vision. The user may use this device when examining the posterior segment of a patient's eye and during treatment of a retinal tear or RRD.

[0163] Method 400 then proceeds to step 406, in which the user uses probe 101 or 201 with the needle retracted so that the needle does not extend beyond the distal end of probe 101 or 201, thereby compressing the sclera with the scleral end of probe 101 or 201 or another suitable probe described herein to locate the retinal tear(s). One of the localization / visualization techniques described herein may be used in Method 400 to ensure that the needle is in the correct position on the eyeball and inserted substantially perpendicular to the sclera.

[0164] Once the user has located a retinal tear(s), method 400 proceeds to step 408, where the user may extend the needle 106 to a depth of approximately 0.3 mm to approximately 1.5 mm using the needle actuator 108 to reach the tear in the SCS. One of the needle extension techniques described herein may be used, which may include using one or more sensors, one or more visualization techniques, and any combination of one or more safety mechanisms described herein, including motor-driven or stepwise manual slow advancement of the needle under applied injection pressure.

[0165] Method 400 then proceeds to step 410, which is optional. In step 410, depending on the implementation of a guide tool for probe 101 or 201 or other suitable probes described herein, any combination of light, OCT measurement, US imaging and resistance feedback may be used to confirm that the tip of needle 106 is located within the SCS.

[0166] Method 400 then proceeds to step 412, where the user injects a treatment fluid, such as a viscoelastic agent or other substance, into the patient's SCS, as previously described. The user continues injecting the treatment fluid until a sufficient amount has been injected. For example, a sufficient amount may be considered injected when choroidal blebs form around the entire periphery of the retinal tear(s) and extend, for example, but not limited to, approximately 4 mm to 5 mm outward from the edge of the retinal tear in all directions. The volume of treatment fluid used may vary based on the number, size, and location of the retinal tears. For example, approximately 0.7 cc to 1 cc of treatment fluid may be injected in most cases. The formation of choroidal buckles from the choroidal indentations below the retinal tears alters the intraocular hydrodynamics (i.e., intraocular fluid flow), reducing traction on the retinal tears, thereby preventing little to no fluid from entering the subretinal space through the retinal tears, and allowing the retina to reattach as the retinal pigment epithelium reabsorbs the fluid from the subretinal space. This choroidal buckle can be implemented in any quadrant, including the lower quadrant, using the techniques and devices described herein.

[0167] In an alternative embodiment, a second injection may be performed after the first injection. Since the first injection has already created separation between the choroid and sclera, the second injection can be performed much more easily than the first injection. Therefore, for the second injection, the needle may be extended to a larger length, for example, about 1 mm to about 2 mm. The second injection will be easier because the bleb already present from the first injection reduces the likelihood of the needle 106 penetrating into the subretinal or vitreous space due to the larger gap in the SCS. Furthermore, the needle can therefore be made longer, thereby making it easier to manipulate and position it into the correct space where the existing viscoelastic material is present. In other words, the second injection of the treatment fluid may be performed at the location of the first bleb of the treatment fluid. This is another advantage of using a device having an extendable needle as taught herein for the second injection, as the amount of needle extension can be adjusted depending on where the second injection is required. In some situations, for example, if an excessive amount of viscoelastic material is injected, which could result in an excessive increase in intraocular pressure, or if certain further procedures, such as vitrectomy, are required after the ST procedure, it may be desirable to remove the injected viscoelastic material. In these cases, the variable extension of the needle can be used again, and the needle can be advanced to a certain extension beyond the lower surface of the distal end (therefore, substantially, the length of the needle used to enter the suprachoroidal space and then puncture the eye to aspirate the viscoelastic material changes, with or without additional guidance). In some cases, it may be desirable to treat multiple sites in the same eye because the patient has multiple retinal tears. This can be achieved by forming smaller localized blebs around each tear, or by performing the treatments sequentially at 24-hour intervals to avoid injecting an excessive amount of treatment fluid at once and causing an excessive increase in intraocular pressure.

[0168] Referring here to Figure 4B, a flowchart of another exemplary embodiment of Method 420 for treating a retinal tear or RRD according to the teachings herein is shown therein. Method 420 is somewhat similar to Method 400 as it includes steps 402-412 for preparing the device and making an injection. However, Method 420 includes an additional step of draining in the patient's eye before making an injection. Since Method 420 involves draining, probe 201 or another suitable probe described herein may be used. For example, step 422 may be performed after step 406, in which the user compresses the sclera using probe 201 with the needle retracted to locate a retinal tear. Step 422 includes the user determining whether draining needs to be done. This may involve the user examining the patient's eye with an indirect ophthalmoscope and / or a wide-angle observation system equipped with a condensing lens and allowing a wide peripheral field of view of the posterior segment. If the retina is severely vesicular, this may increase the likelihood that the user will consider adding draining to the procedure. If drainage is used, this may allow the retina to make better contact with the choroidal buckle formed by the viscoelastic material, thereby increasing the likelihood that the choroidal buckle will effectively close the retinal tear and reduce the flow of fluid through the retinal tear into the subretinal space. If the user determines that drainage is not necessary, for example in the case of shallower retinal detachment where the choroidal buckle provides sufficient indentation to close the retinal tear without drainage, method 420 includes performing steps 408-412 as described for method 400. This may also include performing a second injection later as described above. Alternatively, if the user determines in step 422 that drainage is necessary, method 420 proceeds to step 444, where the user uses the needle actuator 108 to extend the needle tip to a length (depth) of about 1.5 mm to about 3 mm. The needle tip is extended by approximately 1.5 mm to 3 mm, so that the needle 106 is safely positioned within the subretinal space but far enough away from the retina to avoid pinching it or causing a retinal tear. Method 420 then proceeds to step 426, where active or passive drainage is performed as described above.The user may decide to stop draining by visually confirming that the retinal detachment in the patient's eye has subsided, the fluid has left the subretinal space, and the retina has flattened / reattached. Before the needle touches the retina, the user stops draining and removes or slightly retracts the needle. After aspiration is performed, method 420 proceeds to step 408, at which point the user may have to reposition the needle at the location of the retinal tear before advancing the needle into the SCS. In other embodiments of this method, draining may be performed after the injection of the viscoelastic substance rather than before, or draining may be performed only without the injection of the viscoelastic substance.

[0169] Referring here to Figures 4C–4N, images are shown illustrating different stages in repairing a retinal tear or RRD according to the teachings herein. In Figure 4C, the eye 450 of a patient showing a rhegmatogenous retinal detachment (RRD) 452 with a fold of the outer retina 454. As can be seen, a probe with a boss is used in this example. However, as previously described, a probe without a boss can be used. The patient has a temporal retinal tear 456, and the arrow indicates that liquefied vitreous humor has entered the subretinal space through the retinal tear 456. In Figure 4D, the probe 460 for suprachoroidal space delivery of a viscoelastic material according to the teachings herein is advanced and precisely positioned so that the needle of the probe 450 is at the desired ocular surface position at the location of the retinal tear in question. In Figure 4E, a guide light beam 463 may be directed toward the surface of the eye to assist in positioning. In Figure 4F, when the user determines that the needle is in the correct position on the ocular surface, the needle 462 begins to extend and the needle 462 begins to penetrate the ocular surface. In Figure 4G, the needle 462 penetrates the sclera 458, and some injection pressure is applied as the needle advances through the sclera. Due to the dense scleral fibers, no injection pressure creates a flow of viscoelastic material until the needle 462 enters the SCS. In Figure 4H, once the needle enters the suprachoroidal space, the viscoelastic material 464 flows from the probe 460 through the needle conduit into the SCS, forming a choroidal depression / buckle 466, which can then be retracted and the probe 460 removed. In Figure 4I, the choroidal depression / buckle 466 reduces / blocks the flow of liquefied vitreous humor from the vitreous cavity to the subretinal space. The retinal pigment epithelium (RPE) 468 regains control of the subretinal space and reabsorbs subretinal fluid (as indicated by the arrows). In Figure 4J, the RPE 468 has reabsorbed most of the subretinal fluid, and the retina is nearly completely attached. In Figure 4K, the retina is fully attached, and laser retinal photocoagulation 470 may be applied to form a permanent chorioretinal adhesion between the retina and RPE 468 around the retinal tear. In some cases, cryocoagulation may be applied to the retinal tear before injection of a viscoelastic substance into the choroid, thereby eliminating the need for laser retinal photocoagulation later.In Figure 4L, laser retinal photocoagulation is completed around the retinal tear. The laser burn transforms into a scar 472 that causes retinochoroidal adhesion. In Figure 4M, retinochoroidal adhesion 474 has formed around the tear. The viscoelastic material 464 on the choroid has begun to reabsorb, resulting in a reduction of choroidal indentation / buckle 467. In Figure 4N, the retina is fully attached. Good chorioretinal adhesion is present, and the viscoelastic material in the suprachoroidal space has been completely reabsorbed.

[0170] It should be noted that the use examples of the devices described herein relate to providing a treatment fluid for treating retinal tears or RRDs, but it should be understood that various embodiments of the devices described herein can be used for precise localization and precise needle penetration depth for various other ophthalmic procedures, which is particularly advantageous when the treatment site is provided from the posterior part of the eye. Furthermore, in these various ophthalmic procedures, the treatment fluid may be, but is not limited to, a drug, gene therapy, hydrogel, or a different type of viscoelastic fluid. For example, the devices described herein can be used for more precise targeted delivery of drugs to the posterior part of the eye without relying on drug diffusion, thereby allowing the drug to be precisely injected into or adjacent to the diseased ocular tissue. Furthermore, hydrogels with sustained delivery of novel or orphan drugs can be precisely injected to the required site. For example, a hydrogel or other sustained-release platform may be used in conjunction with one of the embodiments of the devices described herein to deliver any pharmacologist to the posterior part of the eye. This includes, for example, drugs for treating age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion, proliferative vitreoretinopathy, macular edema, hereditary retinal diseases, intraocular tumors, posterior segment inflammation, vascular abnormalities, parafoveal telangiectasia, Coats' disease, retinopathy of prematurity, familial exudative vitreoretinopathy, and other diseases of the retina and choroid. One embodiment of the device described herein may also be used to directly administer treatments into the SCS or subretinal space, and these treatments include, but are not limited to, antibody therapies, antibody fragments, aptamers, orphan drug solutions, gene therapies, and the like.

[0171] The various devices and methods described herein, in accordance with the teachings, are also advantageous compared to conventional drug / agent delivery systems for the subretinal and superchoroidal spaces, which rely on anterior scleral perforation / incision, allowing a cannula / catheter to be advanced through the superchoroidal space. Conventionally, agents are injected into the superchoroidal space, or a needle may be used to perforate the choroid and retinal pigment epithelium to inject the agent into the subretinal space. The problem with this approach is that it requires a more invasive operating room procedure, scleral incision, and tunneling of a cannula / catheter in the SCS. These procedures carry inherent risks, which can be avoided by using one of the devices described herein, and the procedure can be simplified, with which direct scleral perforation (with transconjunctival or minor conjunctival incision) at the precise desired location for delivery of the agent to the SCS, subretinal space, or another part of the eye.

[0172] By using appropriate curves / angles and lengths of the probe to reach any desired scleral position, and by extending the needle from the side of the distal end of the probe adjacent to the scleral surface, precise localization and needle depth accuracy at a desired location on the eyeball of the patient's eye can be improved according to the teachings herein. Here, the needle is inserted directly (or transconjunctivally) through the sclera at an appropriate angle to the sclera (preferably nearly perpendicular, e.g., 90 degrees) to allow scleral penetration into the SCS, choroidal / RPE penetration into the subretinal space, or other penetration into other areas of the eye. By using guide tools and / or one or more sensors described herein, accuracy can be further improved, allowing the needle to accurately reach the desired target layer (suprachoroidal or subretinal) without over-penetration or under-penetration. The accuracy and ease of use of the devices described herein can be further improved by using one or more of the operating mechanisms described herein to precisely position the needle and penetration depth, and / or by providing the safety mechanisms described herein to prevent over- or under-penetration of the needle and the use of excessive force during needle insertion.

[0173] At least one embodiment of the devices and methods described herein may be used for one or more purposes, for example, a) injecting a viscoelastic agent into the SCS at a predetermined location in the area of ​​a retinal tear in question to treat an RRD; b) draining subretinal fluid in the area of ​​the RRD; c) delivering a drug to the SCS at a posterior location such as the macula; d) delivering a drug to the subretinal space at a posterior location such as the macula; and e) draining epichoroidal fluid / hemorrhage or subretinal fluid / hemorrhage.

[0174] Referring here to Figure 4O, a flowchart of an exemplary embodiment of Method 480 for performing precise localization and precise needle depth penetration on the surface of the eye for ophthalmic procedures is shown. Method 480 may be performed by using one of the devices described herein in accordance with the teachings.

[0175] In step 482, setup is performed to prepare the device for use. This may involve performing calibration and also loading material into the device (if it is not pre-filled with material). Necessary tubing and wiring may be connected (if required), and the device may be primed if necessary. Self-contained devices do not require tubing or wiring.

[0176] In step 484, the device is moved by the user, and the distal end of the device is positioned at a desired location on the sclera or conjunctiva by forming an indentation as previously described. At or anterior to the equator, this can be done directly on the conjunctiva. At posterior to the equator, a small conjunctival incision may be required. Note that a small conjunctival incision is usually not significant, but a scleral incision is more invasive. This desired location can be confirmed by indirect ophthalmoscopy (in other words, by the user observing the inside of the eye and visualizing the indentation formed by the distal end portion to confirm precise positioning) or by using wide-field observation in the operating room. The desired location can also be confirmed using at least one of the sensors described herein.

[0177] In step 486, since the user has predetermined whether the injection / aspiration is a) choroidal or b) subretinal, the user can determine the penetration depth before inserting the needle into the eye by measuring the thickness of the eye layers and / or structures using, for example, imaging methods such as OCT, ultrasound or other optical methods, guide tools, and / or sensing mechanisms described herein.

[0178] In step 488, the needle is extended into the eye, which may be done manually or using an automated method as described herein. The needle is extended from the side of the distal end of the device, which may be near the tip of the distal end, or it may be ejected (e.g., extended) from the side of the probe adjacent to the ocular surface, which side is adjacent to the scleral surface and has an appropriate angle / orientation toward the suprachoroidal or subretinal space through the sclera.

[0179] In step 490, for SCS injection, injection pressure is applied as the needle advances through the sclera, and injection occurs as soon as the needle enters the SCS, preventing excessive needle penetration depth. For subretinal injection, the needle is advanced, and injection pressure is applied so that a subretinal fluid bleb is formed as soon as the needle penetrates the RPE when the needle is in the choroid and close to the RPE. For aspiration from the SCS, aspiration is initiated while the needle is in the sclera, and fluid is allowed to flow as soon as the needle enters the SCS. For subretinal aspiration, aspiration is initiated when the needle is confirmed in the subretinal space. Needle positioning (e.g., penetration depth) can be confirmed using one of the guide tools and / or sensing mechanisms described herein, such as, but not limited to, fiber optic light / laser, laser reflectivity, or insertion resistance, to confirm the precise needle penetration depth.

[0180] In step 492, while the injection / aspiration is being performed in the SCS or subretinal space, the user (e.g., surgeon) may be observing the inside of the eye using either indirect ophthalmoscopy or wide-field intraoperative observation to evaluate the desired clinical endpoint.

[0181] In step 494, once the clinical endpoint is reached, the user can withdraw the needle or remove it from the eye. Intraocular pressure can be assessed by evaluating optic nerve perfusion. If the central retinal artery is pulsatile or occluded, slow anterior chamber puncture can be performed to reduce the pressure. This should be done in small amounts, as excessively rapid pressure reduction can cause bleeding.

[0182] In step 496, it is determined whether repeated treatment or reinjection / re-aspiration may be required, as this may occur depending on the circumstances.

[0183] Example 1: Intra-clinical suprachoroidal viscopexy for rhegmatogenous retinal detachment repair The results of applying a minimally invasive in-clinic procedure embodiment of the ST method for treating RRD are discussed below.

[0184] Method A 50-year-old male with pseudophakic eye presented with decreased best corrected Snellen visual acuity of 20 / 50 OD and visited St Michael's Hospital, Unity Health Toronto. Figures 5A to 5C show time-course ultra-wide field photographs of the pseudophakic eye of this male who presented with rhegmatogenous retinal detachment in the right eye. Figure 5A shows a baseline image illustrating an inferotemporal rhegmatogenous retinal detachment involving the fovea from 6 o'clock to 10 o'clock, and no clear causative retinal break is identified. The rule of Lincoff and Gieser 12Based on this, the retinal tear was presumed to be located in the temporal or superior temporal quadrant. After discussing treatment options and obtaining written informed consent, the patient was placed under subconjunctival anesthesia, and 1% sodium hyaluronate (Provisc, Alcon) was injected into the superior temporal quadrant using an early prototype having an application similar to some of the device embodiments described herein. This prototype included a 30-gauge needle with a custom-made guard that exposed 1 mm of the needle. The custom guard was fabricated using an intravenous tube (Med-RX, Canadian Hospital Specialties Ltd). A syringe filled with viscoelastic material was connected to the needle. The injection site at the location of the suspected retinal tear was confirmed intraocularly using indirect ophthalmoscopy (to ensure the needle was not too deep), and then 0.4 mL of viscoelastic material was slowly injected transconjunctivally under direct visualization while a dome-shaped choroidal bulge formed. During the injection, as the choroidal bleb began to form, the patient felt an initial pressure (as did the assistant performing the injection), which lessened as the bleb expanded and remained tolerable for the remainder of the procedure. Anterior chamber puncture was not required as central retinal artery perfusion was confirmed. Video of the choroidal elevation forming intraocularly was not obtained in the outpatient procedure, but a similar technique was performed intraoperatively in two other patients and used as a combined PPV and ST method for additional support of inferior and temporal retinal tears. In particular, Figure 6 shows the final appearance of the choroidal elevation formed after the ST method was performed. We followed Kempen's guidelines for case series reporting.

[0185] result The patient was able to resume normal activities without restriction the day after the procedure. The macula had completely reattached the day after the ST procedure. For example, Figure 5B shows an image 1 day after the ST procedure, showing significant regression of retinal detachment with several initial spots of laser retinal photocoagulation applied to the temporal peripheral region. A small, localized temporal hemorrhage was observed near the injection site.

[0186] Time-series wavelength-swept optical coherence tomography (SS-OCT) showed reattachment with rapid recovery of the outer foveal limiting membrane and ellipsoidal zone integrity (see Figures 8A-8D). The patient progressed through the reattachment stages without any anatomical abnormalities: Figure 8A shows the baseline scan. Figure 8B shows the postoperative day 1 scan with significant improvement in outer retinal wrinkles and cystoid macular edema (stage 2). Figure 8C shows the postoperative day 2 OCT scan showing contact between the retina and retinal pigment epithelium (stage 3). Figure 8D shows the postoperative day 3 scan showing the resolution of rod-cone layer swelling (stage 4). On postoperative day 5 (not shown), the patient showed improvement in the integrity of the outer retinal band (stage 5). The patient achieved complete retinal reattachment with rapid recovery of the outer limiting membrane and ellipsoidal zone integrity. As shown in Figure 9, fundus autofluorescence imaging was performed on postoperative day 5 without any signs of retinal displacement in the posterior pole, indicating that the patient achieved high-complete retinal reattachment (HIRA).

[0187] SS-OCT scans at the choroidal convexity revealed a low-reflection gap between the sclera and choroid, indicating the location of viscoelastic material in the suprachoroidal space (SCS). For example, Figures 10A–10C show longitudinal wavelength-swept optical coherence tomography scans in the temporal macula and temporal midperiperiphery, with the ST method location indicated on the left side of the image. The arrows point to viscoelastic material that can be observed in the low-reflection space between the sclera and choroid, indicating the location of viscoelastic material in the suprachoroidal space over the first week postoperatively. Figure 10A shows the scan on postoperative day 1, Figure 10B shows the scan on postoperative day 3, and Figure 10C shows the scan on postoperative day 5. A progressive decrease in the height of this low-reflection gap is observed throughout the entire period after the ST method (arrows).

[0188] Laser retinal photocoagulation was performed on the suspected retinal tear area on postoperative day 1 (see Figures 5B and 5C). For example, Figure 5C shows the condition 3 days after ST procedure, demonstrating complete laser retinal photocoagulation barricade in the suspected causative retinal tear area. Mild residual subretinal fluid was observed in the lower peripheral region, but no open tear was found, and the condition gradually improved. For example, ultra-wide-field fundus-swept OCT scans showing complete reattachment of the macular region are shown in Figures 11A and 11B. In particular, Figure 11A shows a low-reflection space between the choroid and sclera (indicated by arrowheads), indicating viscoelastic material in the suprachoroidal space. Figure 11B shows the residual downstream retina, which slowly resolved over time, with mild residual lower subretinal fluid without folds in the outer retina at the lowest peripheral region (star).

[0189] The choroidal convexity decreased in size during the first week (see Figures 7A and 7B) and completely disappeared by week 2. Figures 7A–7B were obtained by longitudinal vertical sweep optical coherence tomography at the viscopexy injection site. Figures 7A–7B show the progressive absorption of viscoelastic material (low-reflectance space between the choroid and sclera, indicated by arrowheads) in the suprachoroidal space from postoperative day 1 (Figure 7A) to postoperative day 5 (Figure 7B). The extent of viscoelastic material in the suprachoroidal space was determined using a 12 × 12 mm volume cube performed in the temporal midperiphery. By postoperative day 5, the best corrected visual acuity was 20 / 25, and this visual acuity remained stable throughout the first month of follow-up.

[0190] Consideration The ST method can be performed in a clinic and appears to be relatively less invasive compared to conventional methods of viscoelastic substance injection into the SCS, but carries risks of choroidal hemorrhage, infection, and unintentional intraocular injection or retinal perforation. The procedure in this study was performed using an initial prototype with a custom 30-gauge needle guard, using an intravenous tube that allows for the injection of viscoelastic substance into the SCS from a syringe filled with viscoelastic substance and fluidically coupled to a guarded needle, with 1 mm of the needle exposed. Significant resistance is observed when the needle is in the sclera during injection, and this resistance is relieved when additional pressure causes the needle to advance slightly into the SCS.

[0191] From the research, the inventors believe that performing the ST method on an outpatient basis in selected patients may be a reasonable approach. This procedure may be well-suited for acute RRD without proliferative vitreoretinopathy and may be preferred in cooperative patients with a tear within one clock time. This procedure may be particularly beneficial for inferior tears where pneumatic retinal reattachment is unlikely to be successful; however, since the absence of tamponade and positional requirements is a key advantage of the ST method, it may also be performed for superior tears according to the teachings herein. Furthermore, the ST method may be performed in combination with PPV or pneumatic retinal reattachment for additional support of the retinal tear. In some cases, 2.3% sodium hyaluronate (Healon 5, Abbott Medical Optics) may be preferred because it remains in the SCS for up to 3 weeks and maintains a useful effect for at least 7-10 days.

[0192] The advantages of performing this technique according to the teachings herein include the complete spontaneous reabsorption of viscoelastic agents, minimal invasiveness with injection using a small needle, and the fact that these substances are immunologically inactive. Viscoelastic agents with longer-acting properties may be superior. Furthermore, some of the complications associated with conventional SB surgery can be avoided.

[0193] In one embodiment, according to the teachings herein, at least one embodiment of a device for use in a patient having an eye having rhegmatogenous retinal detachment (RRD) or a retinal tear is provided, wherein the device is a probe, the probe having a body having a longitudinal axis and a distal end that is angled / curved or straight with respect to the longitudinal axis; an injection conduit for receiving a treatment fluid for injection into the suprachoroidal space (SCS) of the eye to treat RRD or a retinal tear; a needle positioned at the distal end of the probe, the needle having a needle conduit fluidically coupled to the injection conduit for injecting the treatment fluid into the SCS of the eye; and an actuator controllable by the user to cause the treatment fluid to move from the injection conduit through the needle conduit into the SCS of the eye.

[0194] In another embodiment, according to the teachings of this specification, at least one embodiment of a device for injecting fluid into or draining fluid from a patient's eye is provided, wherein the device includes: a probe, the probe having a body having a longitudinal axis and a distal end that is angled or straight with respect to the longitudinal axis of the body; one or more probe conduits for moving fluid through the probe; a distal curved end having a lower surface, the portion of which is positioned adjacent to the surface of the eye when in use; and an extendable needle located at the distal end of the probe, the needle having a needle conduit fluidly coupled to one or more probe conduits for injecting fluid into or draining fluid from the eye, and the needle being extended substantially perpendicularly away from the axis of the distal end of the probe for piercing the sclera.

[0195] In at least one embodiment, the device includes a fluid actuator that can be controlled by a user to cause a fluid to move through a needle conduit between one or more probe conduits and an eye.

[0196] In at least one embodiment, the distal end of the probe has a predetermined radius of curvature, arc length, and arc angle for reaching a desired position on the ocular surface during use, where the radius of curvature substantially matches the radius of curvature of the eye or sclera into which the needle is inserted.

[0197] In at least one embodiment, the distal end has a boss on its underside so that the user can recognize where the needle protrudes from the probe.

[0198] In at least one embodiment, the needle protrudes from the boss when in use.

[0199] In at least one embodiment, the distal end of the probe is rigid.

[0200] In at least one embodiment, the distal end is flexible to adjust the radius of curvature of the lower surface of the distal end.

[0201] In at least one embodiment, the arc angle at the distal end is approximately 15 degrees to approximately 60 degrees.

[0202] In at least one embodiment, the eye has rhegmatogenous retinal detachment (RRD) or a retinal tear, and the device is configured to inject a fluid into the suprachoroidal space (SCS) of the eye through an injection conduit and a needle conduit to treat the RRD or retinal tear.

[0203] In at least one embodiment, a fluid is injected to form a choroidal buckle to treat a renal recessive disease (RRD) or retinal tear.

[0204] In at least one embodiment, one or more probe conduits include an injection conduit for injecting fluid into the eye and an injection conduit for draining fluid from the eye, the needle having a needle position, the needle position being adjustable between an injection position in which the injection conduit is fluidly connected to the needle conduit to drain fluid from the subretinal space or another location in the eye, and an injection position in which the injection conduit is fluidly connected to the needle conduit to inject the treatment fluid into the SCS or another location in the eye such as the subretinal space, choroid or vitreous cavity.

[0205] In at least one embodiment, the device includes a fluid actuator that can be controlled by a user to cause a fluid to move through a needle conduit from the injection conduit to the eye, and / or from the eye to the discharge conduit.

[0206] In at least one embodiment, the probe includes a needle actuator that is adjustable by the user to adjust the needle position between a discharge position and an injection position.

[0207] In at least one embodiment, the probe includes a needle position indicator for showing the needle position to the user.

[0208] In at least one embodiment, upon discharge, the tip of the needle is configured to extend approximately 1.5 mm to 3 mm into the eye to reach a subretinal position within the eye.

[0209] In at least one embodiment, at the injection site, the needle is configured to extend approximately 0.3 mm to approximately 1.5 mm intraocularly for a first injection into the SCS, or the needle is configured to extend approximately 1 mm to approximately 2 mm intraocularly for a second injection into the SCS.

[0210] In at least one embodiment, the fluid actuator and / or needle actuator are each coupled to a pedal and / or switch configured to be controlled by the user.

[0211] In at least one embodiment, the needle includes a circumferential opening which is fluidly coupled to a discharge conduit when the needle is in a discharge position and to an injection conduit when the needle is in an injection position.

[0212] In at least one embodiment, the discharge conduit includes a discharge cylinder having a distal end that is fluidly coupled to a circumferential pore of the needle conduit when the needle position is the discharge position, and the injection conduit includes an injection cylinder located within the discharge cylinder and having a distal end that is fluidly coupled to a circumferential pore of the needle conduit when the needle position is the injection position.

[0213] In at least one embodiment, the probe has a form factor that makes the probe handheld, and the distal end of the probe is shaped to allow the user to depress the sclera of the eye during use, with the distal end of the probe in a state formed as a scleral depressor.

[0214] In at least one embodiment, the device has at least one sensor for enabling the user to locate a retinal tear or retinal detachment or to locate a site for drug delivery within the eye during use.

[0215] In at least one embodiment, the probe includes at least one sensor, which is any combination of an electrical impedance sensor, a mechanical resistance sensor, a pressure sensor, and a flow sensor, for measuring electrical impedance, insertion resistance, and / or injection resistance, where the electrical impedance, insertion resistance, or injection resistance near the location of the needle tip is used to determine when the needle tip is in the sclera or SCS of the eye.

[0216] In at least one embodiment, the device further includes a guide light source configured to generate a guidance light beam having one or more predetermined wavelengths to indicate that the needle tip has penetrated different layers of the eye by a change in light intensity.

[0217] In at least one embodiment, the device further includes an optical guidance sensor for detecting the reflection of a guidance light beam and generating positional data based on the position where the detected reflected light beam exhibited a different light intensity when the needle tip was located within the sclera or SCS of the eye.

[0218] In at least one embodiment, the device further includes a guide tool optically coupled to the distal end of the probe to assist the user in positioning the distal tip of the needle at the rupture site, wherein the guide tool includes a light source for illuminating the distal tip of the needle.

[0219] In at least one embodiment, the device further includes a guide tool optically coupled to the distal end of the probe to assist the user in positioning the distal tip of the needle at the rupture site, wherein the guide tool is an optical coherence tomography (OCT) device, an optical coherence elastography (OCE) device, an endoscopic imaging device, an optical intensity sensing device, an optical scattering sensing device, an optical wavelength sensing device, a laser sensing device, or an optical polarization sensing device.

[0220] In at least one embodiment, the device further includes a guide tool that generates sound waves emitted from the distal end of a probe to assist a user in positioning the distal tip of a needle at a fissure site, wherein the guide tool is an ultrasonic imaging device or an acoustic reflection measurement device.

[0221] In at least one embodiment, the device further includes a control unit comprising a display, a memory unit for storing software instructions for performing one or more functions, a device interface for receiving measurement data from a probe, and a processor communicatively coupled to the memory unit, the interface, and the display, wherein the processor is configured to perform one or more functions when executing software instructions, and the one or more functions include receiving measurement data and displaying at least a portion of the measurement data on the display.

[0222] In at least one embodiment, the measurement data includes any combination of insertion resistance, injection resistance, and / or electrical impedance, which are used to determine the needle penetration depth to indicate the position of the needle tip within the eye.

[0223] In at least one embodiment, the device includes a processor-controllable pump, an injection port for receiving an injection tube that is fluidically coupled to an injection conduit of a probe, and an internal injection conduit that is fluidically coupled to the injection port and the pump, wherein the pump is connected to a fluid source, and during injection, the processor is configured to send a pump control signal to the pump to generate an injection pressure for moving fluid from the fluid source to the eye.

[0224] In at least one embodiment, the injection fluid may also be pre-loaded into the device, or the device may be filled with the injection fluid immediately before use.

[0225] In at least one embodiment, the injection pressure is set to a predetermined injection pressure level that is adjustable from about 20 mmHg to about 70 mmHg.

[0226] In at least one embodiment, the device includes a processor-controllable pump, at least one suction port for receiving at least one suction tube fluidly coupled to a probe discharge conduit, and an internal discharge conduit fluidly coupled to at least one suction port and the pump, wherein the pump is connected to a discharge container, and during discharge, the processor is configured to send a pump control signal to the pump to generate suction pressure to move the discharge fluid from the eye to the discharge container.

[0227] In at least one embodiment, the wastewater may be collected in a discharge tube within the device.

[0228] In at least one embodiment, the suction pressure is set to a predetermined suction pressure level that is adjustable in the range of 0 mmHg to about 700 mmHg.

[0229] In at least one embodiment, the actuator is coupled to a control unit, so that when activated by the user, the fluid actuator sends actuator control signals to a processor to control injection or discharge at the probe.

[0230] In at least one embodiment, the probe includes an optical conduit positioned along an injection conduit, the control unit includes an optical port for receiving an optical fiber optically coupled to the optical conduit, and the control unit further includes an internal optical conduit optically coupled to the optical port and a light source.

[0231] In at least one embodiment, the device may also include its own internal light source, thereby eliminating the need for an external light source.

[0232] In at least one embodiment, the probe includes an optical conduit positioned along an injection conduit, and the control unit includes an OCT device, an optical interference elastography (OCE) device, an endoscopic imaging device, a light intensity sensing device, a light scattering sensing device, a light wavelength sensing device, or a light polarization sensing device, an optical port for receiving an optical fiber optically coupled to the optical conduit, an internal optical conduit optically coupled to the optical port, and a display for displaying one or more images provided by the OCT device, an optical interference elastography (OCE) device, an endoscopic imaging device, a light intensity sensing device, a light scattering sensing device, a light wavelength sensing device, or a light polarization sensing device.

[0233] In at least one embodiment, the probe includes an ultrasonic transducer located at the distal end of the probe, and the control unit includes an ultrasonic imaging device or acoustic reflection measurement device coupled to the ultrasonic transducer for receiving an ultrasonic signal or acoustic reflection measurement, processing the received ultrasonic signal to generate an ultrasonic image, or processing the received acoustic reflection measurement, and further displaying the ultrasonic image or processed acoustic reflection measurement on a display.

[0234] In at least one embodiment, the processor is configured to display operating parameters, including any combination of measured resistance, injection pressure, suction pressure, and position data, on a display.

[0235] In at least one embodiment, the control unit includes a speaker or vibrator communicably coupled to a processor, the processor being configured to generate an audio signal or vibration and to output the audio signal via the speaker or vibration via the vibrator, wherein the audio signal includes voice, tone or beep, and the audio signal or vibration corresponds to device operating parameters and / or measurement data including injection pressure, suction pressure or any combination of other data.

[0236] In at least one embodiment, a vibrating device may be included to provide vibrational feedback within the probe to give tactile feedback, the tactile feedback preferably being gentle (e.g., having a small amplitude).

[0237] In at least one embodiment, the probe further includes a flange at its distal end in order to maintain the position of the distal end of the probe and the tip of the needle relative to the surface of the eye.

[0238] In at least one embodiment, the flange further includes one or more pressure sensors for measuring pressure at one or more points on the flange, communicating with a control unit, the control unit being configured to provide a visual or auditory output indicating the measured pressure.

[0239] In at least one embodiment, the device further includes a variable coupler located at the distal end of the probe, which is adapted to attenuate the pressure applied to the eye by the distal end of the probe when the pressure or force applied to the eye during use is above a threshold.

[0240] In at least one embodiment, the variable coupler includes a pressure relief valve that releases pressure if the pressure applied to the eye during use is above a threshold, or a force damper that releases pressure if the force applied to the eye during use is above a threshold.

[0241] In at least one embodiment, the probe is retractable to extend its distal end.

[0242] In another embodiment, according to the teachings herein, at least one embodiment of a method for treating a patient having an eye with rhegmatogenous retinal detachment (RRD) or a retinal tear is provided, wherein the method comprises setting up an ophthalmic treatment device having a probe and a needle, wherein the needle is set up to have an adjustable needle position; examining the patient's eye; using the device with the needle retracted to press and confirm one or more retinal tears; advancing the needle position to an injection position to move the needle toward the suprachoroidal space (SCS) of the patient's eye; confirming the position of the needle tip using a guide tool; and injecting a treatment fluid so that the treatment fluid enters the SCS of the patient's eye.

[0243] In at least one embodiment, injection is initiated just before the tip of the needle enters the SCS.

[0244] In at least one embodiment, injection is initiated while the needle is advancing through the sclera, and a decrease in injection resistance is used to indicate when the needle has passed through the sclera and entered the SCS.

[0245] In at least one embodiment, when the needle is in the injection position, the tip of the needle extends about 0.3 to about 1.5 mm.

[0246] In at least one embodiment, the method further includes repeating the method to administer an additional infusion of the treatment fluid to the patient on the same day or on another future day.

[0247] In at least one embodiment, for a second injection, the tip of the needle extends about 1 to about 2 mm.

[0248] In at least one embodiment, the treatment fluid is a viscoelastic fluid, an inert gas or air, a hydrogel, a sustained-release implant, or a drug solution.

[0249] In at least one embodiment, the drug solution contains a preservative or is preservative-free, and / or the drug solution is used for antibody therapy, gene therapy, steroid therapy, or other pharmacological therapy.

[0250] In at least one embodiment, the viscoelastic agent comprises hyaluronic acid, crosslinked hyaluronic acid, 1% to 2.3% sodium hyaluronate, and a soluble or insoluble hydrogel spacer.

[0251] In at least one embodiment, when it is determined to drain fluid from the subretinal space of a patient's eye, the method further includes advancing the needle position to a drainage position and performing active or passive fluid drainage from the subretinal space before or after injection into the SCS.

[0252] In at least one embodiment, at the discharge position, the tip of the needle extends approximately 1.5 to 3 mm into the eye and into the subretinal space without touching the retina.

[0253] In at least one embodiment, a controllable needle actuator is used for the forward and backward movement of the needle, and the needle actuator is controlled by the user.

[0254] In at least one embodiment, a fluid actuator is used for injecting a treatment fluid, and the fluid actuator is controlled by the user.

[0255] In at least one embodiment, the guide tool includes any combination of a light source, an optical coherence tomography (OCT) device, an optical coherence elastography (OCE) device, an endoscopic imaging device, a light intensity sensing device, a light scattering sensing device, a light wavelength sensing device, a light polarization sensing device, an ultrasonic imaging device, an acoustic reflectance measurement device, and a handheld lens.

[0256] In at least one embodiment of the method, the device is defined based on any of the embodiments described herein.

[0257] In another embodiment, at least one embodiment of the use of a device having a needle for treating a patient's eye is provided according to the teachings of this specification, wherein the device is defined based on any of the embodiments described herein.

[0258] In another embodiment, a method is provided for injecting or draining a fluid into / from a patient's eye, according to the teachings herein, the method comprising: positioning a probe, as defined according to a suitable embodiment described herein, such that the lower surface of the distal end of the probe presses against the surface of the eye to be treated; extending the tip of a needle into the eye to a desired depth from the lower surface of the distal end of the probe, wherein the needle extends substantially perpendicular to the axis of the distal end of the probe; determining the depth of the needle tip using at least one sensor and / or visual guide tool; injecting or draining a fluid into / from the eye when the needle tip is at the desired depth; and removing the needle from the eye.

[0259] In at least one embodiment, according to the teachings herein, a self-contained handheld device is provided for injecting or draining fluid into / out of a patient's eye, wherein the device has a probe shape and includes: a body having a longitudinal axis and a distal end having a longitudinal axis that is angled with respect to the longitudinal axis of the body or is linear; one or more probe conduits for moving fluid through the probe; a distal end having a lower surface, the portion of which is positioned adjacent to the surface of the eye when in use; an extendable needle positioned at the distal end of the probe, the needle having a needle conduit that is fluidically coupled to one or more probe conduits for injecting or draining fluid into / out of the eye, and extending substantially perpendicularly away from the longitudinal axis of the distal end of the probe for piercing the sclera; a needle actuator and needle actuator control for extending or retracting the needle; and a fluid actuator and fluid actuator control for controlling the injection or draining of fluid.

[0260] In at least one embodiment, the device includes an input button configured to allow a user to set the device to operate in either an injection mode or an ejection mode.

[0261] In at least one embodiment, the device includes at least one sensor for measuring data related to the penetration depth of the needle tip in use.

[0262] In at least one embodiment, the device includes a light source for generating a guidance light beam that is projected from the distal end of the probe toward the eye during use.

[0263] In at least one embodiment, the device includes a microcontroller for controlling the operation of the device, and the microcontroller is located within the probe.

[0264] In at least one embodiment, the device includes a power supply.

[0265] In at least one embodiment, the device includes a treatment fluid container for providing the treatment fluid during injection.

[0266] In at least one embodiment, the device includes a discharge tube for receiving fluid drained during use, and a drain port coupled to the discharge tube for removing the drained fluid.

[0267] In at least one embodiment, the lower surface of the distal curved end portion has a radius of curvature that approximates the radius of curvature of the eye or sclera at the time of needle penetration, and an arc length that is predetermined based on the position on the eye where the needle penetration is performed.

[0268] The applicant's teachings described herein are explained in relation to various embodiments for illustrative purposes, but are not intended to be limited to such embodiments. Rather, the applicant's teachings described and illustrated herein encompass a variety of alternatives, modifications, and equivalents without generally departing from the embodiments described herein. For example, the teachings described and shown herein may include certain elements / components and processes, while modifications may be made as known to those skilled in the art. For example, features selected from one or more exemplary embodiments described herein in accordance with the teachings herein may be combined to form alternative embodiments not expressly described. For example, as will be apparent to those skilled in the art, the devices and methods described herein may be carried out using various other combinations and permutations of the various features and functions presented, including shape, form factor, needle position or orientation, conduit, adjustment, control, actuator, indicator, guidance element, fluid and other materials, procedure, and application. All values ​​and partial ranges within the disclosed scope are also disclosed. The subject matter described herein is intended to cover and encompass all appropriate technical modifications. References 1.Williams GA,Aaberg TA Jr.Techniques of scleral buckling.In:Ryan SJ,Wilkinson CP,eds.Retina.Vol.3.4th ed.Elsevier Mosby;2006:2035-2207. 2.Moinuddin O, Abuzaitoun RO, Hwang MW, et al.Surgical repair of primary non-complex rhegmatogenous retinal detachment in the modern era of small-gauge vitrectomy.BMJ Open Ophthalmol 2021;6(1):e000651.doi:10.1136 / bmjophth-2020-000651. 3.Heimann H,Hellmich M,Bornfeld N,Bartz-Schmidt KU,Hilgers RD,Foerster MH.Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment (SPR Study):design issues and implications.SPR Study report no.1.Graefes Arch Clin Exp Ophthalmol 2001;239 (8):567-574.doi:0.1007 / s004170100319. 4.Hillier RJ,Felfeli T,Berger AR,et al.The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).Ophthalmology 2019;126(4):531-539.doi:10.1016 / j.ophtha.2018.11.014. 5.Brosh K,Francisconi CLM,Qian J,et al.Retinal displacement following pneumatic retinopexy vs pars plana vitrectomy for rhegmatogenous retinal detachment.JAMA Ophthalmol 2020;138(6):652659.doi:10.1001 / jamaophthalmol.2020.1046. 6.Francisconi CLM,Marafon SB,Figueiredo NA,et al.Retinal displacement after pneumatic retinopexy versus vitrectomy for rhegmatogenous retinal detachment (ALIGN).Ophthalmology 2022;129(4):458-461.doi:10.1016 / j.ophtha.2021.12.007. 7.Lee WW,Bansal A,Sadda SR,et al.Outer retinal folds after pars plana vitrectomy vs.pneumatic retinopexy for retinal detachment repair:post hoc analysis from PIVOT.Ophthalmol Retina 2022;6(3):234-242.doi:10.1016 / j.oret.2021.09.001. 8.Muni RH,Felfeli T,Sadda SR,et al.Postoperative photoreceptor integrity following pneumatic retinopexy vs pars plana vitrectomy for retinal detachment repair:a post hoc optical coherence tomography analysis from the pneumatic retinopexy versus vitrectomy for the management of primary rhegmatogenous retinal detachment outcomes randomized trial.AMA Ophthalmol 2021;139(6):620-627.doi:10.1001 / jamaophthalmol.2021.0803. 9.Bansal A,Naidu SC,Marafon SB,et al.Retinal displacement after scleral buckle versus combined buckle and vitrectomy for rhegmatogenous retinal detachment:ALIGN scleral buckle versus pars plana vitrectomy with scleral buckle.Ophthalmol Retina Published online May 20,2023.doi:0.1016 / j.oret.2023.05.012. 10.McKay BR,Bansal A,Kryshtalskyj M,Wong DT,Berger A,Muni RH.Evaluation of Subretinal fluid Drainage Techniques During Pars Plana Vitrectomy for Primary Rhegmatogenous Retinal Detachment-ELLIPSOID Study.Am J Ophthalmol 2022;241:227-237.doi:0.1016 / j.ajo.2022.05.008. 11.Farahvash A,Marafon SB,Juncal VR,Figueiredo N,Ramachandran A,Muni RH.Impact of tamponade agent on retinal displacement following pars plana vitrectomy for rhegmatogenous retinal detachment repair:a computer simulation model.Acta Ophthalmol 10.1111 / aos.15118. 12.Lincoff H,Gieser R.Finding the retinal hole.Arch Ophthalmol 971;85(5):565-569.doi:0.1001 / archopht.1971.00990050567007. 13.Kempen JH.Appropriate use and reporting of uncontrolled case series in the medical literature.Am J Ophthalmol 2011;151(1):7-10.e1.doi:0.1016 / j.ajo.2010.08.047.

Claims

1. A device for injecting or draining fluid into or from the eye, Here, the device is A main body having a distal end, A needle having a needle conduit, extending and retracting from an exit position on the side surface of the distal end, The probe comprises one or more probe conduits for moving the fluid through the probe, the probe including one or more probe conduits that are fluidly coupled to the needle conduit, A device in which, during use, the side portion having the outlet position is positioned adjacent to the surface of the eye, the needle extends to penetrate into the eye, and the fluid is injected or discharged through the needle conduit.

2. The device according to claim 1, wherein the needle is configured to exit the probe such that it is substantially perpendicular to the tangent to the side surface at the exit position.

3. The device according to claim 1 or claim 2, wherein the side surface is concave and has a radius of curvature that substantially matches the radius of curvature of the sclera.

4. The device according to any one of claims 1 to 3, wherein the longitudinal axis of the distal end is at an angle with respect to the longitudinal axis of the main body.

5. The device according to any one of claims 1 to 4, wherein the device comprises a needle actuator coupled to the needle and controllable to extend and retract the needle.

6. The device according to any one of claims 1 to 5, comprising a fluid actuator coupled to the needle and controllable to move the fluid through the needle conduit between the one or more probe conduits and the eye.

7. The device according to any one of claims 1 to 6, wherein a boss is provided on the side surface at the exit position, and the needle is configured to extend and retract through the boss, or a boss is provided on the side surface adjacent to the exit position, and the needle is configured to extend and retract adjacent to the boss.

8. The device according to any one of claims 1 to 7, wherein the one or more probe conduits comprises an injection conduit and an discharge conduit, and the probe is equipped with a coupling that can switch between a state in which the discharge conduit is fluidly coupled to the needle conduit and a state in which the injection conduit is fluidly coupled to the needle conduit.

9. The device according to any one of claims 1 to 8, further comprising a guide light source configured to generate a guide light beam for illumination or to indicate that the tip of the needle has penetrated into different layers of the eye by a change in transmitted or reflected light.

10. The device according to any one of claims 1 to 9, further comprising at least one guide tool configured to perform measurements for determining the location of the tip of the needle and / or the target injection site or discharge site within the eye.

11. A device according to any one of claims 1 to 10, wherein the device further includes a control unit that is contained within the probe or located separately from the probe, The control unit, The display is optional, A memory unit that stores software instructions for executing one or more functions, A device interface that receives measurement data and transmits control signals for the operation of the device, A speaker or vibration device that generates an audio signal or vibration corresponding to the operating parameters and / or measurement data of a device, and optionally includes a speaker or vibration device, A processor that is communicatively coupled to any of the memory unit, the interface, the speaker or the vibration device, and the display, A power supply that provides power to the components of the aforementioned device Includes, The processor is configured to perform one or more functions when executing the software instructions, and the one or more functions Receiving the aforementioned measurement data, Transmitting the aforementioned control signal, To generate the aforementioned audio signal or vibration, This includes displaying at least a portion of the measurement data on the display, device.

12. The device according to any one of claims 1 to 11, comprising a pump fluidically coupled to one or more probe conduits, wherein the pump is controllable to generate injection pressure when the fluid is injected into the eye and to generate discharge pressure when the fluid is discharged from the eye.

13. The device according to any one of claims 1 to 12, wherein the probe further comprises a flange and / or a variable coupler at the outlet position, thereby maintaining position or pressure between the side and the eye surface.

14. The device according to claim 13, wherein the flange and / or the variable coupler further comprises one or more sensors for measuring the position and / or pressure at one or more points between the side surface of the distal end of the probe and the surface of the eye.

15. The device according to any one of claims 1 to 14, further comprising an injection fluid container and / or a discharge fluid container connected to one or more probe conduits.

16. The device according to any one of claims 1 to 15, wherein the needle is configured to extend to a depth within the suprachoroidal space, subretinal space, or vitreous space of the eye.

17. The device according to any one of claims 1 to 15, wherein the eye has a rhegmatogenous retinal detachment (RRD) or a retinal tear, and the device is configured to inject fluid into the suprachoroidal space of the eye to form a choroidal buckle for treating the RRD or retinal tear.

18. The device according to any one of claims 1 to 17, wherein the fluid comprises a treatment fluid comprising any combination of a drug, gene therapy, sustained-release implant, viscoelastic substance, hydrogel, and gas.

19. A method for injecting or draining fluid into or from the eye, The distal end of the probe is positioned adjacent to the surface of the eye, The probe has a needle having a needle guide tube, The aforementioned needle is in a retracted position, To penetrate the eye, the needle is extended from the exit position on the side surface of the distal end of the probe, A method comprising injecting or discharging fluid between the probe and the eye through the needle conduit.

20. The method according to claim 19, comprising extending the needle in a direction substantially perpendicular to the tangent to the side surface of the probe at the exit position.

21. The method according to claim 19 or 20, wherein the side surface of the distal end of the probe is concave and has a radius of curvature that substantially matches the radius of curvature of the sclera.

22. The method according to any one of claims 19 to 21, wherein the longitudinal axis of the distal end is at an angle with respect to the longitudinal axis of the main body.

23. The method according to any one of claims 19 to 22, comprising using a needle actuator for controlling the extension and retraction of the needle.

24. The method according to any one of claims 19 to 23, comprising using a fluid actuator to control the injection and discharge of the fluid.

25. The method according to any one of claims 19 to 24, comprising using measurements performed by a guide light beam and / or a guide tool to determine the location of the tip of the needle and / or the target injection or discharge site in the eye.

26. The method according to any one of claims 19 to 25, wherein a control unit, which is integrated with or separated from the probe, is used for displaying measurement data from the probe, for transmitting control signals to the probe, and / or for generating an audio signal or vibration corresponding to the operating parameters of the device and / or the measurement data.

27. The method according to any one of claims 19 to 26, comprising extending the needle into the suprachoroidal space, subretinal space, or vitreous space of the eye.

28. The method according to any one of claims 19 to 27, wherein the fluid comprises a treatment fluid comprising any combination of a drug, gene therapy, sustained-release implant, viscoelastic substance, hydrogel, and gas.

29. The method according to any one of claims 19 to 27, wherein the eye has a rhegmatogenous retinal detachment (RRD) or a retinal tear, and the method comprises injecting the fluid into the suprachoroidal space (SCS) of the eye to create a choroidal buckle for treating the RRD or retinal tear.

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