Apparatus and method for posterior segment access of eye with accurate positioning and needle penetration depth

Abstract

The methods and devices described herein are used to a) inject / deliver fluid to and / or expel / remove fluid from an eye. One of the devices may include a probe including: a body having a distal end portion; a needle extending and retracting from an exit location on a side surface of the distal end portion, the needle having a needle catheter; and one or more probe conduits for moving the fluid through the probe, the one or more probe conduits fluidly coupled with the needle conduit. During use, a portion of the side surface having the exit location is placed adjacent to the surface of the eye, and the needle is extended to penetrate the eye, and the fluid is injected or expelled through the needle catheter.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 578,330, filed August 23, 2023, and U.S. Provisional Patent Application No. 63 / 624,372, filed January 24, 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. Technical Field

[0002] The various embodiments described herein generally relate to an apparatus and method for delivering an agent (containing a drug) to the posterior segment of the eye (suprachoroidal space or subretinal space) via direct external scleral penetration with precise positioning and accurate needle depth, such as minimally invasive suprachoroidal delivery for viscoelastic agents, to repair retinal tears or rhegmatogenous retinal detachment. Background Technology

[0003] Over the past century, the repair of rhegmatogenous retinal detachment (RRD) has seen tremendous advancements. Although scleral buckling (SB) has been the mainstream technique for decades... 1 However, since the beginning of the 21st century, pars plana vitrectomy (PPV) has become the preferred treatment for most surgeries. 2 However, it has been reported that functional outcomes after PPV surgery are not as good as those after SB surgery. 3 and pneumatic retinal fixation 4 Advances in multimodal imaging technology have demonstrated PPV. 5-8 A high risk of unwanted structural abnormalities. Recent evidence suggests factors such as subretinal fluid drainage. 9 Using heavy fluids 10 and a large amount of gas filling 11 Additional surgical procedures can be harmful in some cases. This understanding has led surgeons to modify their techniques to not only achieve reattachment in a single procedure, but also to maximize the integrity of the reattachment.

[0004] Conventional techniques for choroidal delivery of viscoelastic agents used to repair retinal tears or detachments involve sclerotomy (e.g., scleral incision) with or without tissue dissection (manual separation of the choroid and sclera) and direct injection of the viscoelastic agent, or inserting a probe through the choroidal space after the incision and injecting the viscoelastic agent once the probe is in the area of ​​the retinal tear. However, these are relatively invasive procedures that must be performed in the operating room (with a potentially greater risk of bleeding and other complications), which increases the cost and delays when the operating room becomes available. Therefore, there is a need for a minimally invasive technique that does not necessarily need to be performed in the operating room and, if performed in the operating room, can be performed without a scleral incision.

[0005] Similarly, techniques for delivering therapeutic agents, such as drugs, to the retina and other structures towards the back of the eye (including the subretinal space) are either invasive (such as ocular incisions and / or subretinal injections) or non-targeted (such as intravitreal injections), leading to risks of complications such as eye damage, vision impairment, and / or dilution of treatment efficacy. Therefore, a minimally invasive technique is needed for targeted delivery of therapeutic agents to the back of the eye via the suprachoroidal and / or subretinal spaces. Summary of the Invention

[0006] In one aspect, in accordance with the teachings herein, at least one embodiment of a device for injecting or draining fluid into or from an eye is provided, wherein the device comprises: a probe including: a body having a distal end portion; a needle extending and retracting from an outlet location on a side surface of the distal end portion, 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 fluidly connected to the needle conduit; wherein during use, a portion of the side surface having the outlet location is placed adjacent to a surface of the eye, and the needle is extended to penetrate the eye, and fluid is injected or drained through the needle conduit.

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

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

[0009] In at least one embodiment, the longitudinal axis of the distal end portion is at an angle to the longitudinal axis of the 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 and controllable to cause fluid to move through a needle conduit between one or more probe conduits and the eye.

[0012] In at least one embodiment, the side surface has a boss at the outlet location and the needle is configured to extend and retract through the boss, or the side surface has a boss adjacent to the outlet location and the needle is configured to extend and retract adjacent to the boss.

[0013] In at least one embodiment, one or more probe catheters include an injection catheter and an discharge catheter, and the probe has a connector that is adjustable between fluidly connecting the discharge catheter to the needle catheter and fluidly connecting the injection catheter to the needle catheter.

[0014] In at least one embodiment, the device further includes a guiding light source adapted to generate a guiding beam for illumination or to indicate when the tip of the needle penetrates different layers of the eye by means of variations in transmitted or reflected light.

[0015] In at least one embodiment, the device further includes at least one guiding tool adapted to perform measurements to determine the location of the needle tip and / or a target injection or expulsion site in the eye.

[0016] In at least one embodiment, the device further includes a control unit housed within or remote from the probe, the control unit comprising: an optional 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 operation of the device; a speaker or vibrator for generating audio signals or vibrations corresponding to device operating parameters and / or measurement data, wherein the speaker or vibrator is optional; a processor communicatively coupled to any of the following: the memory unit, the interface, the speaker or vibrator, and the display, the processor being configured to perform one or more functions when executing the software instructions, the one or more functions including: receiving measurement data; transmitting control signals; generating audio signals or vibrations; and displaying at least a portion of the measurement data on the display; and a power supply for providing power to components of the device.

[0017] In at least one embodiment, the device includes a pump fluidly connected to one or more probe catheters, the pump being controllable to generate injection pressure when fluid is injected into the eye, or to generate discharge pressure when fluid is expelled from the eye.

[0018] In at least one embodiment, the probe further includes a flange and / or a variable coupling at the exit position to maintain position or pressure between the side surface and the surface of the eye.

[0019] In at least one embodiment, the flange and / or variable connector further includes one or more sensors to measure position and / or pressure at one or more points between the side surface of the distal end portion of the probe and the surface of the eye.

[0020] In at least one embodiment, the device further includes an injection fluid container and / or an discharge fluid container coupled to one or more probe catheters.

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

[0022] In at least one embodiment, when the eye suffers from rhegmatogenous retinal detachment (RRD) or retinal tear, the device is adapted to inject fluid into the choroidal space of the eye to generate choroidal buckling for treating RRD or retinal tear.

[0023] In at least one embodiment, the fluid includes a therapeutic fluid comprising any combination of: a drug, gene therapy, a prolonged release implant, a viscoelastic, a hydrogel, and a gas.

[0024] On the other hand, in accordance with the teachings herein, a method for injecting or draining fluid into or from an eye is provided, wherein the method comprises: placing a side surface of a distal end portion of a probe adjacent to a surface of the eye, the probe having a needle with a needle conduit and the needle being retracted; extending the needle from an outlet position on the side surface of the distal end portion of the probe to penetrate 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 includes extending the needle at the exit position substantially perpendicular to the probe side surface in a tangential manner.

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

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

[0028] In at least one embodiment, the method includes using a needle actuator to control the extension and retraction of the needle.

[0029] In at least one embodiment, the method includes using a fluid actuator to control the injection and discharge of fluid.

[0030] In at least one embodiment, the method includes using a guide beam and / or measurements performed by a guide tool to determine the location of the needle tip and / or the target injection or drainage site in the eye.

[0031] In at least one embodiment, a control unit integrated with or separate from the probe is used to display measurement data from the probe, transmit control signals to the probe, and / or generate audio signals or vibrations corresponding to device operating parameters and / or measurement data.

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

[0033] In at least one embodiment, the method includes using a fluid comprising any combination of a therapeutic fluid containing a drug, gene therapy, extended-release implant, viscoelastic material, hydrogel, and gas.

[0034] In at least one embodiment, the eye suffers from rhegmatogenous retinal detachment (RRD) or retinal tear, and the method includes injecting fluid into the suprachoroidal space (SCS) of the eye to generate choroidal cingulates for treating RRD or retinal tear.

[0035] It will be understood that the foregoing description of the invention has set forth representative aspects of the embodiments to assist a skilled reader in understanding the detailed embodiments described below. Other features and advantages of this application will become apparent from the detailed embodiments described below in conjunction with the accompanying drawings. However, it will be understood that the detailed embodiments and specific examples, while indicating preferred embodiments of this application, are given by way of illustration only, and various changes and modifications within the spirit and scope of this application according to these detailed embodiments will become apparent to those skilled in the art. Attached Figure Description

[0036] To better understand the various embodiments described herein, and to more clearly illustrate how these various embodiments can be implemented, reference will be made to the accompanying drawings, which illustrate at least one exemplary embodiment and will now be described by way of example. The drawings are not intended to limit the scope of the teachings described herein.

[0037] Figure 1 This is a diagram of an example embodiment of an ocular treatment device for accurate positioning and precise needle depth insertion, based on the teachings herein, for example, for ocular treatments such as treating retinal tears or rhegmatogenous retinal detachment (RRD) or for delivering drugs, other therapeutic agents, or other therapeutic fluids.

[0038] Figure 2A This is a diagram of an example embodiment of an alternative probe, based on the teachings herein, that can be used with ocular treatment devices for accurate positioning and precise needle depth insertion, such as those used for treating retinal tears or RRDs, or for delivering medications, other therapeutic agents, or other therapeutic fluids.

[0039] Figure 2B This is a diagram of an example embodiment of a control unit used with an eye treatment device taught herein.

[0040] Figure 2C yes Figure 2B A block diagram of an example embodiment of various components of the control unit.

[0041] Figure 3A Several embodiments are shown, illustrating distal ends of probes with different curvatures and lengths for positioning at different locations on the eye.

[0042] Figure 3B It shows Figure 3A A magnified view of the distal end of one of the probes.

[0043] Figures 3C to 3D Examples are shown of placing the distal end of the probe at different locations on the eye, where the needle is inserted and the fluid is injected at different depths.

[0044] Figure 3E An example embodiment of a portion of an ophthalmic treatment device with a pressure distribution flange is shown.

[0045] Figure 3F An example embodiment of a portion of an eye treatment device, a pressure distribution flange, and a variable connector is shown.

[0046] Figure 3G A front view of an example embodiment of a pressure distribution flange with one or more sensors is shown.

[0047] Figure 3H An example embodiment of a replaceable probe that can be used with an eye treatment device for accurate positioning and precise needle depth insertion in eye treatment is shown, wherein the probe is a stand-alone device.

[0048] Figure 4A This is a flowchart of an example embodiment of a method for treating retinal tears or RRDs taught herein.

[0049] Figure 4B This is a flowchart of another example embodiment of a method for treating retinal tears or RRDs taught herein.

[0050] Figures 4C to 4N Images of different stages of a method for repairing retinal tears or RRD are shown.

[0051] Figure 4O A flowchart illustrating an example embodiment of a method for precise positioning and deep penetration on the surface of the eye for ocular surgery is shown.

[0052] Figures 5A to 5CThis image shows a longitudinal ultrawide field photograph of a patient with an intraocular lens that presents with RRD in the right eye.

[0053] Figure 6 The final appearance of the choroidal convexity formed after a treatment on the choroid (ST) procedure as taught in this article is shown.

[0054] Figures 7A to 7B These are longitudinal vertical sweep frequency source optical coherence tomography (SS-OCT) scans performed at the ST injection site on the 1st and 5th day after ST surgery, respectively.

[0055] Figures 8A to 8D The baseline longitudinal SS-OCT scans after ST surgery, the SS-OCT scans on postoperative day 1, postoperative day 2, and postoperative day 3 are shown respectively.

[0056] Figure 9 The image shows an autofluorescence image of the fundus on day 5 after ST surgery.

[0057] Figures 10A to 10C Longitudinal SS-OCT scans performed on the temporal macula and temporal periphery on postoperative days 1, 3, and 5, respectively, show the location of the ST surgery (on the left side of the image).

[0058] Figures 11A to 11B These are OCT scan images, showing the low-reflectivity space between the choroid and sclera (arrows) and the slight residual subretinal fluid (star shape) in the lowest periphery without lateral retinal folds after ST surgery.

[0059] Other aspects and features of the exemplary embodiments described herein will become apparent from the following description taken in conjunction with the accompanying drawings. Detailed Implementation

[0060] The following describes various embodiments in accordance with the teachings herein, providing examples of at least one embodiment of the claimed subject matter. The embodiments described herein do not limit any claimed subject matter. The claimed subject matter is not limited to devices, systems, or methods having all the features of any of the devices, systems, or methods described below, or is not limited to features common to multiple or all of the devices, systems, or methods described herein. Devices, systems, or methods that may have embodiments not described herein are possible. Any subject matter described herein but not claimed in this document may be the subject matter of another protected document, such as a successor patent application, and the applicant, inventor, or owner does not intend to waive, deny, or publicly offer any such subject matter through public disclosure in this document.

[0061] Furthermore, it will be understood that, for the sake of simplicity and clarity, reference numerals may be repeated in the drawings where deemed appropriate to indicate corresponding or similar elements or steps. Additionally, numerous specific details are set forth to provide a thorough understanding of the embodiments described herein. However, those skilled in the art will understand that the embodiments described herein can be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the embodiments described herein. Moreover, this description should not be construed as limiting the scope of the embodiments described herein.

[0062] It should also be noted that the term “coupled” or “coupling” as used herein can have several different meanings depending on the context in which these terms are used. For example, the term “coupled” or “coupling” can have mechanical, electrical, or communication meanings. For example, as used herein, depending on the specific context, the term “coupled” or “coupling” can indicate that two elements or devices can be directly connected to each other, or connected to each other via one or more intermediate elements or devices via electrical elements, electrical signals, optical signals, or mechanical elements.

[0063] Similarly, throughout this specification and the appended claims, the term "communication" as in "communication path," "communication link," and variations such as "communication ground link" is generally used to refer to any engineered arrangement for transmitting and / or exchanging information. Examples of a communication path 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 a communication link include, but are not limited to, electrical links, magnetic links, radio links, optical links, or any combination thereof.

[0064] Unless the context otherwise requires, throughout the specification and the subsequent claims, the word “comprising” and its variations, such as “comprises” and “comprising”, shall be interpreted in an open, inclusive sense, that is, “comprising, but not limited to”.

[0065] It should also be noted that, as used herein, the term “and / or” is intended to indicate an inclusive “or.” That is, “X and / or Y” is intended to mean, for example, X or Y or both X and Y. As another example, the phrases “X, Y and / or Z,” “any operable 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.

[0066] It should be noted that degree terms such as “basically,” “approximately,” and “about” used in this article imply a reasonable deviation of the modified term such that the final result will not be significantly altered. For example, these degree terms can also be interpreted as including a deviation of such as 1%, 2%, 5%, 10%, or 15% of the modified term, if this deviation does not negate the meaning of the term it modifies.

[0067] Furthermore, the numerical ranges described in this document by endpoints include all numbers and fractions contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, and 5). It should also be understood that all numbers and fractions are considered to be modified by the term "approximately," which refers to the maximum amount of variation in the numbers involved, such as 1%, 2%, 5%, 10%, or 15%, if the final result does not change significantly.

[0068] A portion of the example embodiments of the systems, devices, or methods described in this document can be implemented as a combination of hardware and / or software. For example, a portion of the embodiments described herein can be implemented at least in part by using one or more computer programs that execute on one or more programmable devices, the one or more programmable devices including at least one processing element and at least one data storage element (including volatile and / or non-volatile memory). Depending on the nature of the device, these devices may also have at least one input device (e.g., keyboard, mouse, touchscreen, button, switch, dial pad, slider, etc.) and at least one output device (e.g., display, printer, radio, speaker, vibrator, etc.).

[0069] It should also be noted that there may be some elements used to implement at least a portion of the embodiments described herein that can be implemented via software written in a high-level procedural language such as object-oriented programming. As those skilled in the art of object-oriented programming know, the program code can be written in C, C++, or any other suitable programming language and may include modules or classes. Alternatively, or in addition, some of these elements implemented via software may be written in assembly language, machine language, or firmware as needed.

[0070] At least some of the software programs 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 special-purpose 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 method described herein.

[0071] Furthermore, at least some of the programs associated with the systems and methods of the embodiments described herein can be distributed in a computer program product comprising a computer-readable medium carrying computer-usable instructions such as program code for one or more processors. The program code may be pre-installed and embedded during manufacturing, and / or may be installed later as an update to an already deployed computing system. The medium may be provided in various forms, including, but not limited to, one or more disks, optical disks, magnetic tapes, chips, and magnetic and electronic storage devices, which are non-transitory. In alternative embodiments, the medium may be inherently transient, such as, but not limited to, wired transmission, satellite transmission, internet transmission (e.g., download), media, digital and analog signals, etc. The computer-usable instructions may also be in various formats, including compiled and uncompiled code.

[0072] Any module, unit, component, server, computer, terminal, or device described herein that executes software instructions according to the teachings herein may contain or otherwise access computer-readable media, such as storage media, computer storage media, or data storage devices (removable and / or non-removable), such as, for example, magnetic disks, optical disks, or magnetic tapes. Computer storage media may contain volatile and non-volatile, removable and non-removable media implemented in any method or technology 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 disc (DVD) or other optical storage devices, cassette tape, magnetic tape, disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired information and can be accessed by an application, module, or both. Any such computer storage media may be part of a device, or accessible to or connected to a device.

[0073] This document describes various example embodiments of methods and ocular treatment devices that can be used for portions of the eye, such as suprachoroidal and subretinal spaces, accessible from the external sclera. These methods and devices feature precise positioning and accurate needle depth for a variety of ocular treatments, such as, but not limited to, the injection or drainage of fluid substances, and include minimally invasive treatment of retinal tears or RRDs by delivering therapeutic agents such as viscoelastic agents, with the aim of, for example, generating temporal choroidal cingulates. For example, a technique referred to herein as ST surgery can be performed, which involves delivering a therapeutic fluid, such as a viscoelastic agent, into, for example, suprachoroidal spaces for RRD repair. Various devices are described herein for performing ST techniques and for delivering therapeutic fluids in a more predictable manner. In another embodiment, ocular treatments incorporating ST surgery may additionally include aspiration of fluids, such as subretinal fluid / hemorrhage or suprachoroidal fluid / hemorrhage, from the patient's eye. In another embodiment, ocular treatments performed independently of ST surgery may include aspiration of fluids from the patient's eye.

[0074] The various embodiments described herein are designed to be minimally invasive, enabling ocular surgeries / treatments to be performed in minimally invasive medical settings, such as a physician's office, but also in an operating room, depending on the surgeon's comfort and the target injection location (e.g., very posterior locations, such as in the macula, may require a conjunctival incision, and can preferably be performed in an operating room with a wide field of view). However, such surgeries / treatments can also be performed in other medical settings, such as mobile clinics. This is because the various embodiments described herein, providing access and precise positioning, advantageously allow the removal of fluids such as viscoelastic agents or medications from the eye and / or the injection of such fluids into the SCS or other areas of the eye using a needle, without requiring a more invasive incision / catheter approach. Advantageously, the devices and methods described herein provide accurate ocular positioning and precise needle depth penetration on the external sclera, which simplifies the performance of various ocular treatments, reducing the risks associated with performing these treatments and potentially improving surgical success and patient outcomes. Furthermore, the precise positioning and needle depth accuracy techniques described herein allow for needle insertion that is relatively non-invasive compared to surgery, allowing for faster patient recovery with little or no downtime, even with limited mobility. This is unlikely to happen in more invasive, conventional operating room techniques.

[0075] Now for reference Figure 1This document illustrates an example embodiment of an ophthalmic treatment device 100 for performing various ophthalmic surgeries, including treatment of retinal tears or RRD, in accordance with the teachings herein. 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 be referred to as an injection conduit, and a needle 106. The body has a longitudinal axis 102L and a distal end portion 103 including a curved portion 102c relative to the longitudinal axis 102L. The longitudinal axis of the distal end portion 103 may be angled relative to the longitudinal axis 102L of the probe 101, or it may be straight (i.e., parallel to the longitudinal axis of the probe). Furthermore, in at least one embodiment, such as when performing positioning at a more anterior scleral position, the distal end portion 103 may bend according to the radius of curvature, be slightly curved, or straight (or only at a very shallow angle). Injection catheter 104 is adapted to receive fluids, such as therapeutic fluids, for injection into areas of the eye, such as the suprachoroidal space (SCS) of a patient's eye for the treatment of retinal detachment or retinal tear, or for injecting therapeutic agents into areas of the eye, such as the SCS or subretinal space, for the treatment of retinal or other ocular symptoms. A needle 106 is disposed at the distal end of probe 101 and has a needle conduit 106c fluidly connected to injection catheter 104 for injecting therapeutic fluid into the SCS of the eye, or, depending on the ocular treatment, into other locations of the eye such as the subretinal space, choroid, or vitreous body. The proximal end of needle conduit 106c is fluidly connected to injection catheter 104.

[0076] During use, the tip of needle 106 and the distal end of the corresponding needle conduit 106c are placed at the injection site, such as within the sclera (SCS) of the patient's eye. Therefore, needle 106 is preferably positioned along the distal end 102c of probe 101, preferably on the lateral surface of the probe rather than at the tip (i.e., not on the most distal end surface of the distal end of the probe), such that needle 106 is substantially perpendicular / substantially perpendicular to the tangent of the scleral surface (and also substantially perpendicular to the longitudinal axis of the distal end portion 103) before insertion into the sclera. This means that needle 106 will be inserted in a direction substantially pointing towards the center of the eyeball (e.g., the center of the patient's eye). Therefore, needle 106 is preferably retracted such that it does not extend beyond the surface of the distal end portion of the probe placed adjacent to the eye. Once needle 106 is in proper position, it can extend such that it extends from the exit position on the surface of the distal end portion of the probe into the eye. A small hole may be present at the exit position, which is positioned around the needle 106 as the needle 106 extends, such that the needle at the exit position is substantially perpendicular to the tangent of the lateral surface of the distal end portion of the probe. Furthermore, in at least one embodiment, for example, a guiding mechanism and / or motorized / manual graded advance of the needle can be used to properly insert the needle 106 into the sclera and advance it to a desired depth, such as the SCS. Because the needle 106 penetrates (or permeates) the sclera to the same depth as its length, and for other reasons described below, this allows for more precise knowledge of the insertion depth of the needle tip. The needle 106 can be selected from any gauge needle, but is preferably selected from gauges 21 to 31, such as a gauge 30 needle or a gauge 27 needle.

[0077] Probe 101 has a portion that allows its proximal end to (e.g., when the probe is as follows) Figure 1 and 2AThe upper portion (shown vertically) is a shape factor held in the hand. The distal portion 102c of the probe has a shape similar to or larger than the "working end" of a scleral depressor, and the longitudinal axis of the distal portion 102c may be angled relative to the longitudinal axis 102L. The spherical tip may have a thickness, for example, from about 3 mm to about 30 mm. For example, the width of the distal end of the probe placed adjacent to the patient's eye during ST surgery is typically large enough to accommodate the needle length and some other components, so the width / thickness of the distal end of the probe 101 may be from about 3 mm to about 30 mm, or more preferably from about 4 mm to about 15 mm. Additionally, the length (i.e., arc angle) of the curved end portion 103 of the probe 101 may be selected according to the location of the eye into which the needle is inserted. The radius of curvature of the distal end portion 103 may be selected to be similar to (i.e., approximately matching or approximately the same as) the curvature of the eye into which the needle is inserted (e.g., the sclera). Typically, depending on the application, the arc angle of the distal portion of the probe can range from approximately 0 to 90 degrees, approximately 20 to approximately 90 degrees, approximately 0 to approximately 50 degrees, or approximately 30 to approximately 40 degrees. When performing localization at different scleral locations, probes with different arc angles in their distal portions can be used. For example, an arc angle of approximately 0 to approximately 30 degrees can be used for anterior locations. In another example, an arc angle of approximately 15 to approximately 45 degrees can be used for intermediate peripheral locations. In another example, an arc angle of approximately 30 to approximately 60 degrees or greater can be used for more posterior locations. Similarly, when performing localization at different scleral locations, probes with different lengths for the curved portion of the distal portion (as defined by the arc angle of the distal portion) can be used. It should be noted that the diagrams of the distal portions of probes 101 and 201 (see...) Figure 2A (This is not to scale and is provided as an example.)

[0078] The distal end of probe 101 can be used by medical practitioners such as, for example, ophthalmologists or vitreoretinal surgeons, hereinafter referred to as the user, to manipulate, depending on the eye surgery being performed, a position posterior to the curvature of the eye (i.e., the posterior portion), or along any anterior or posterior position of the eye. For example, during use, posterior manipulation can be directed to the location of a retinal tear and pressed against the sclera of the patient's eye. The placement of the distal end of probe 101 on the posterior surface of the eye allows it to be aligned with a desired location, such as the location of a retinal tear in this example, which can be confirmed using an indirect ophthalmoscopy. For example, the user can examine the posterior segment of the eye with a 28D or 20D lens and an indirect ophthalmoscopy. One hand of the user can hold the lens and the other hand can hold probe 101 or 201, and the indirect ophthalmoscopy is mounted on the user's head. The lens and / or indirect ophthalmoscopy can also be considered as a guiding tool. This then allows the user to determine (e.g., locate) the location of a retinal tear or RRD tear in the patient's eye during use. Additionally, the scleral depressor shape of the distal end of probe 101 or 201 allows the user to access many parts of the posterior segment of the patient's eye and to apply pressure / pressure to the sclera of the patient's eye. This scleral depression allows for better visualization of the retinal tear by observing the inside of the eye with an indirect ophthalmoscopy. Once the depression is visualized and found to be well-centered around the retinal tear, the user can begin injecting the therapeutic fluid using one of the techniques described herein. Visualization of the inside of the eye can also be achieved in the operating room using wide-field visualization and direct or pendant lighting.

[0079] In at least one embodiment of the device described herein, the distal end of any of the probes described herein is large enough to accommodate (e.g., include space) the extension / retraction of a needle and other elements providing additional functionality. For example, one or more sensors may be located at the distal end of the probe. Alternatively, or in addition to the sensors(s), the distal end portion may have one or more openings or windows that perform various functions, such as allowing the needle to extend and retract into the distal end portion, and allowing a light beam from a light source to pass through the probe end. For example, the light beam may be used for transmission through the sclera to allow the user to know the exact location of the needle entry point, such as relative to the location of a retinal tear. In one or more embodiments, the sensors, openings, windows, or other such features may be positioned along the surface of the side of the distal end portion, rather than at the tip of the distal end portion 102e (e.g., the end face of probes 101, 201 that intersects the longitudinal axis of the distal end portion of the probe).

[0080] In examples of treatments involving fluid injection, such as in the treatment of retinal tears or RRD, a fluid actuator 112 is fluidly coupled to a needle 106 and is controllable (e.g., user-controlled) to move a fluid, such as a treatment fluid, through needle conduit 106c and the SCS or other location in the eye between one or more probe conduits (e.g., from injection conduit 104). The fluid actuator 112 may be fluidly coupled to a treatment fluid source 116 via a tube 118, which may also be referred to as a conduit or line, such that the fluid actuator 112 can cause the treatment fluid to pass through tube 114 into injection conduit 104. In other embodiments, the fluid actuator 112 may be housed within the body of the probe 102, and tube 114 may also be housed within the body of the probe 102 or may not be required. When injecting a fluid other than the treatment fluid, the treatment fluid source 116 may be more generally referred to as a fluid source. In examples of treating retinal detachment, the treatment fluid may consist of a viscoelastic agent. However, more generally, in at least one embodiment described herein, the therapeutic fluid may comprise any combination of any drug, gene therapy, stem cells, extended-release implant, viscoelastic material, hydrogel, gas, or any other agent or material for delivery to the suprachoroidal space, subretinal space, sclera, choroid, or some other ocular location. Probe 101 may have a port 110 for fluidly coupling tube 114 to injection catheter 104. Fluid actuator 112 may include a pump for applying injection pressure to move the therapeutic fluid from therapeutic fluid source 116 through injection catheter 104 to the tip of needle catheter 106c into the patient's eye. The injection pressure used may be predefined but may vary in some cases. For example, the injection pressure may vary based on certain equipment factors such as the lumen size of the tube and the size of needle catheter 106c, as well as certain preferences that the user may have. For example, the injection pressure may vary from approximately 35 mmHg to approximately 70 mmHg, although approximately 50 mmHg may be preferred. For example, the injection pressure used when the needle 106 is advanced / extended into the patient's eye can be approximately 50 mmHg, allowing the user to visualize a bubble forming in the SCS (i.e., an "SCS bubble"). A bubble is a bubbly, space-like formation created between two tissue layers by a fluid, drug, or material. Bubble formation can vary based on the viscosity and other rheological properties of the fluid, drug, or material. Once the user visualizes the SCS bubble forming, they can decide to increase or decrease the injection pressure to increase or decrease the injection rate.

[0081] The therapeutic fluid source 116 can be a container (e.g., an injection container, which may also be referred to as an injection fluid container), bag, or tube containing therapeutic fluid for supplying to probe 101 during use. For example, when the therapeutic fluid is in a tube, the tube can be removably slid into the body 102 of probe 101 and fluidly connected to catheter 104. Therefore, in such cases, a fluid port may not be required. Where the tube can be inserted into the probe body, the tube can be a cylinder with an opening at one end covered by a membrane, and a spike may be present in the device near the proximal end of catheter 104 that pierces the membrane to allow fluid to enter catheter 104 from the tube, which is then in fluid communication with needle catheter 106c. An actuator, such as a lever or dial (neither shown), can be used to increase pressure to move fluid through needle catheter 106c. In at least one embodiment, the probe is preloaded with therapeutic fluid, or the therapeutic fluid can be filled before use by inserting a container, bag, or tube, or by filling a fluid chamber contained within the probe.

[0082] The fluid actuator 112 may, in some cases, be a motor that applies force to a moving object to move fluid into the eye. This force may be mechanical or pneumatic and applied at a point between the fluid source and the needle tip to ultimately result in the injection of fluid into the patient's eye. The fluid actuator 112 may be wired or wirelessly coupled to a pedal and / or switch, both of which are configured to be controlled by a user using device 100 to perform ophthalmic surgery (such as the ST approach) on a patient with an eye suffering from a retinal tear or RRD. While the user holds probe 101 with one hand, the user can control the fluid actuator 112 via the pedal with one foot, or if there is a switch on probe 101 for controlling the fluid actuator 112, the user can use the same hand while the other hand holds a lens for viewing the patient's eye with an indirect ophthalmoscopy. In an alternative embodiment, the fluid actuator 112 may be voice-activated, allowing the user to provide specific voice commands to activate and deactivate the actuator. When the fluid actuator 112 is activated, therapeutic fluid is supplied from therapeutic fluid source 116 through tubes 118 and 114 to injection catheter 104, and then to needle catheter 106c for injection into the patient's eye.

[0083] Alternatively, when the target location is the SCS, the user can engage the fluid actuator 112 to begin applying injection pressure while the needle 106 is positioned within the sclera (although there is no flow or limited flow when the needle is within the sclera because the sclera obstructs flow), and then slowly advance the needle 106 while continuing to apply injection pressure. Once the needle tip enters the SCS, with little or no resistance to the fluid flow from the needle, fluid will begin to flow, and the choroidal cingulate will begin to form. By applying injection pressure as the needle is slowly advanced, this will cause a choroidal vesicle to form as soon as the needle enters the SCS, before the needle penetrates too deeply into the eye (i.e., into the choroid). Once the needle enters the SCS and the choroidal vesicle forms, this can act as a visual notification and prevent the needle 106 from penetrating deeper structures such as the choroid or subretinal space in situations such as treating retinal tears or RRDs. The reduction in injection resistance and the increase in fluid flow also provide feedback to the user that the needle is in the correct position and should not be advanced further. Injection resistance is the mechanical resistance to fluid flow from the needle and can be measured using a pressure sensor (pressure increases when attempting to inject against high resistance) or a flow sensor (flow remains low even when pressure is applied if resistance is high). The general relationship is pressure = flow rate * resistance.

[0084] Therefore, one or more sensors capable of measuring these values ​​can be included in the device to provide data that can be referred to as position data. It should be noted that since there is no flow when the needle 106 is in the sclera but flow is present as soon as the needle enters the SCS, the bubble is not a guide bubble but a full bubble used to identify the space for injecting the therapeutic fluid. Therefore, when the user engages the fluid actuator 112 so that it is active when the needle is in the SCS, the therapeutic fluid will be injected into the SCS of the patient's eye, and when the user stops engaging the fluid actuator 112 so that it is inactive, the injection of the therapeutic fluid stops. Such a device setup allows the user to focus more on accurately holding the probe 101 in place during ophthalmic procedures such as ST surgery, while the switch / pedal / voice control allows for controlled delivery of the therapeutic fluid. For example, depending on the probe / device embodiment, voice commands such as "Inject now" or "Stop injection" can be provided for the automated operation of the fluid actuator. The system may also have confirmatory questions such as "Are you sure you want to start the injection?" to which the user answers "yes / no". For the "Stop Injection" command, fluid actuation can be immediately disabled. For example, similar voice commands such as "Start Aspiration Now" and "Stop Aspiration" can be used for aspiration.

[0085] When extending from the body at the distal end of the probe, the needle 106 has a needle position, in Figure 1In some embodiments, this needle position is referred to as the injection position (in some embodiments, there may also be an ejection position, in which the needle extends to a certain length to eject a certain area of ​​the eye). The needle 106 also has a needle position, referred to as the retracted position, when fully contained within the distal end of the probe. In some cases, it may be preferred that the needle is in the retracted position when the probe is placed in the desired position to avoid abrasion or injury to the eye, and then only the needle is extended to the injection position. In the injection position, the tip of the needle 106 (i.e., the needle tip) is adapted to extend approximately 0.3 mm to approximately 1.5 mm into the patient's SCS for performing a first injection. This range of needle length is due to the difference between the patient and the location on the eyeball, which may have different scleral thicknesses and require the tip of the needle 106 to be inserted to a greater or lesser depth. In at least one embodiment, the probe 101 may include a needle actuator 108 that is controllable (e.g., user-adjustable) for adjusting the needle position. For example, if a user must administer a second injection to a patient after the first injection, the user can use needle actuator 108 to further extend the tip of needle 106, inserting the tip of needle 106 into a deeper location in the patient's eye, such as approximately 1 mm to approximately 2 mm, for administering the second injection to the patient's SCS. Needle actuator 108 can also be used to move the needle from a retracted position to an extended position, or from an extended position to a retracted position. Needle actuator 108 can be physically engaged by the user or engaged using voice commands as described for fluid actuators. Generally, 0.8 mm can be used as a starting point, and the needle tip can be extended further if there is no choroidal bulge. However, in some locations, a 0.8 mm needle extension may be too deep, and the user may need to use a shorter initial needle extension for needle 106. This depth can be assessed by the user under visualization with an indirect ophthalmoscopy or in a wide-field operating room. It should be noted that although in some cases the scleral thickness will be less than 1 mm, the extension of needle 106 will also be less than 1 mm in such cases.

[0086] Because the tip of needle 106 can extend to be inserted into the patient's eye at different depths, needle actuator 108 may include a needle position indicator (not shown) to visually indicate the possible insertion depth at the current needle position. For example, needle actuator 108 may be a slider physically coupled to needle 106 to move needle 106 to change the distance of the tip of needle 106 relative to the distal end of probe 101 from which the needle extends, and the needle position indicator may include a line or protrusion on the slider and a digital scale on probe body 102 indicating the length the tip of needle 106 can be inserted based on the current position of needle 106. For example, the slider may be manually controlled by the user to advance needle 106 in small increments, such as 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 needle 106. In at least one embodiment, needle actuator 108 may be electrically powered.

[0087] In an alternative embodiment, since it may be difficult to see the needle length using a position indicator when the user is visualizing the inside of the patient's eye with a handheld lens, a speaker can be used to generate audio output to notify the user of the needle length 106 as the needle position moves, allowing the user to know the needle depth. This can be achieved, for example, via the use of a needle actuator 108 and a control unit 250 (see, for example, see...). Figure 2C A motion sensor is connected to the probe 101 to sense movement of the needle position and generate needle movement data. This needle movement data is then processed by a control unit 250, which generates an audio signal provided as an audio output via a speaker 268. Alternatively, a series of ridges may be spaced at known distances, such as 1 mm, on the body 102 of the probe 101, and may include ridges on the needle actuator such that each time the needle actuator 108 extends the tip of the needle 106, a ridge on the needle actuator 108 may slide over one of the ridges on the body 102 and produce a sound such as a click to notify the user that the tip of the needle has extended a distance equal to the spacing between the ridges on the body 102.

[0088] In at least one embodiment, the probe 101 may additionally include a sensor 107 positioned within the injection catheter 104 or needle catheter 106c to measure injection resistance near the distal end of the needle 106. Figure 1In the example embodiment shown, sensor 107 is located within the distal end of catheter 106c. The sensor can be a pressure sensor, and injection resistance can be considered as the back pressure present at the distal end of needle catheter 106c and refers to the resistance encountered by the therapeutic fluid when it is injected into the eye. Alternatively, the sensor can be a flow sensor that measures the flow rate of the fluid when injection pressure is applied. Alternatively, the sensor can be a pressure sensor or a resistance sensor to measure needle insertion resistance. Insertion resistance is the mechanical resistance to the movement of a needle into the eye, which can be measured using a force sensor or a pressure sensor. The sclera, SCS, choroid, and subretinal space of the eye have unique insertion resistance values ​​due to differences in density / material at these ocular locations. Therefore, sensor 107 can be used to measure the insertion resistance that can be used to estimate whether the tip of needle 106 is in the sclera or SCS or some other part of the patient's eye. For example, in the case of an injection resistance sensor, the inventors have discovered that if the tip of needle 106 is in the sclera, there is high injection resistance, but once the tip of needle 106 is advanced into the SCS, if injection has been initiated by applying a sufficient amount of injection pressure, the injection resistance decreases and a bubble forms at the tip of needle 106. If the user initiates injection when the resistance is low, the therapeutic fluid propagates well to the injection site. Alternatively, when the needle tip is in the sclera, the user can slowly apply injection pressure and slowly advance needle 106, and then once insertion or injection resistance decreases, it indicates that the needle tip is in the SCS, and the choroidal bubble will be visualized, and the user can then increase the flow rate of the therapeutic fluid. For example, actuator control can be implemented such that pressing a switch or foot pedal connected to the fluid actuator 112 with more force can increase the amount of injected therapeutic fluid (e.g., in a linear manner, where the increased force results in an increase in the flow rate of the therapeutic fluid), or the amount of injected therapeutic fluid can be automated based on a measured reduction of injection or insertion resistance of at least approximately 50%. For example, this can be performed by the processor 270 of the control unit 250 when receiving and processing the interpolated values ​​of the measurement (see, for example, see...). Figure 2C Another alternative could be to initially generate the choroidal vesicle at a more forward position where it is easier to insert the needle 106 into the correct location, and then, once the local choroidal vesicle has been generated at the forward position, the length of the needle could be slightly increased, and the subsequent portion could be injected more fully into the SCS, allowing the choroidal vesicle to propagate more posteriorly to the site of the retinal tear.

[0089] Sensor 107 can also be any combination of an impedance sensor, a mechanical resistance sensor, and a flow sensor. Sensor 107 is positioned within a probe or needle cannula or on the outer surface of the probe or needle to measure the insertion, injection, or resistance approximately at the distal end of the needle, where the resistance approximately indicates the position of the needle tip in the eye to determine whether the needle tip is in the sclera or the SCS of the eye. A mechanical resistance sensor can be implemented using a pressure sensor or a force sensor. Impedance sensors and flow sensors will be described in further detail below.

[0090] In at least one embodiment, device 101 may have a processor and a display, such as an LED display, for acquiring and displaying measured insertion, injection, or resistance to provide resistance feedback to the user to notify them when to begin injection. In some embodiments, the display may be optional, such as for example... Figure 3H A separate device within the device. Alternatively, or in addition, in at least one embodiment, the processor may be configured to automatically activate the fluid actuator to inject the therapeutic fluid when resistance feedback indicates that the needle tip is in the correct position for injecting the therapeutic fluid. In at least one embodiment, the measured resistance value may be compared to a resistance threshold, and resistance feedback cues may be provided to the user via a visual display or audio cues once the measured resistance value is below the resistance threshold, and / or the fluid actuator may be activated to automatically begin injecting the therapeutic 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 is greater than a resistance change threshold, resistance feedback cues may be provided to the user visually and audibly and / or injection may begin automatically. Such thresholds may be determined experimentally and may be based on any combination of patient age, patient sex, and whether the patient has an eye disease that causes thickening or thinning of the sclera.

[0091] As described above, in at least one embodiment, probes 101 and / or 201 can use impedance to detect whether the needle tip is in the sclera or the SCS because different tissue types may have different impedances. For example, the resistance sensor can be an impedance sensor that may include a measuring electrode located at or near the tip of needle 106 and a reference electrode also located near the tip of needle 106 or in another part of probes 101, 201 and connected to ground. As the needle tip extends into the patient's eye, an impedance measurement is performed as the measuring electrode contacts the scleral tissue; this impedance measurement will approximate a first value that can be referred to as scleral impedance. As the needle tip extends further and enters the SCS, impedance measurements continue, and the impedance measurement will approximate a second level that can be referred to as SCS impedance. Scleral impedance differs from SCS impedance. Therefore, as the needle tip extends into the patient's eye, an impedance value can be measured, and when the measured impedance value changes from a scleral impedance value to an SCS impedance value, a signal can be provided to the user to notify them to begin injecting the therapeutic fluid and / or the fluid injection can be automatically initiated as previously described.

[0092] It should be noted that when the needle 106 is in the SCS, the depth of the tip of the needle 106 can vary from patient to patient and from one location to another in a given patient's eye. Therefore, in at least one embodiment, the tip of the needle 106 may be extended to an initial length for the SCS injection, but may then be extended slowly, little by little (e.g., incrementally), and the injection may occur little by little (e.g., incrementally) until the measured insertion resistance indicates proper placement of the tip of the needle 106. For example, once the distal end 103 of the probe 101 is in the area of ​​a retinal tear or rupture (which can be visualized by indirect ophthalmoscopy or wide-field visualization based on the indentation generated by the distal end of the probe), the needle 106 can be controlled to slowly penetrate the sclera, such as in an incremental manner. This can be done by a motorized method, such as by using a stepper motor. As the tip of the needle 106 extends, the user can visualize the sclera behind the tip indentation of the needle, or visualize the needle as it penetrates the sclera of the eye (with the aid of light passing through the needle cavity). The user can visually confirm that the needle 106 is not too deep, and the user can keep the needle 106 extended to a set length, i.e., approximately 0.3 mm, approximately 0.9 mm, approximately 1 mm, approximately 1.2 mm, or any depth selected by the user. The user can also use visual cues to limit the depth of needle penetration (or puncture depth). For example, a guiding tool (described below) can be used to observe the movement of the needle tip, including observing needle insertion, when the needle has passed through the sclera and reached the SCS, and, under applied injection pressure, observing the initiation of injection fluid, and stopping needle extension so that the needle does not penetrate deeper into the structure. These methods provide assurance against excessive penetration. The incremental extension of needle 106 can be achieved using a processor-controlled stepper motor coupled to a slider, rotary dial, etc., for incrementally sliding / extending the tip of needle 106 away from the distal end of probe 101, and also retracting needle 106 into the distal end of the probe tip. A user-controlled switch or foot pedal can be provided and communicatively coupled to the stepper motor to provide the user with finer control over the incremental extension and retraction of needle 106 during use. The switch or foot pedal mechanism can be the same as that used for automated injection of therapeutic fluid, such that there are two switches on probe 101, two buttons or two portions of a foot pedal on probe 101, and the user can engage one of the switches or the first portion of the foot pedal to move the needle, and then engage the other switch or the second portion of the foot pedal to begin injection of therapeutic fluid or to begin aspiration (see below, for example). Alternatively, or in addition, in at least one embodiment, voice control can be used to control the extension / retraction of the needle. Such a mechanism can also be applied to other probes described herein, such as probe 201.

[0093] For example, during use, as the needle retracts, the user presses the distal end of probe 101 or 201 against the sphere, and once the correct position on the sphere is identified, the user activates the motor control and needle 106 begins to extend slowly. As needle 106 extends, the actuator for injecting the therapeutic fluid is also activated; however, when the needle tip is in the sclera, the therapeutic fluid will not exit from the needle tip (due to insufficient injection pressure to overcome injection resistance in the sclera) until the needle tip enters the SCS, where a bubble will automatically form. Once the bubble 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 reduce the flow rate, resulting in a slower delivery of the therapeutic fluid for more controlled injection. In at least one embodiment, probe 101 or 201 may have a flow sensor to detect when the therapeutic fluid begins to flow out of the needle tip. When flow is detected, if a motor is used to extend the needle tip, the motor can be turned off to stop advancing the needle tip. At this point, the needle can be locked in place, and the therapeutic fluid can continue to be injected until a sufficient amount has been injected (as described in this article). Additionally, intraocular pressure may increase as fluid flows into the SCS.

[0094] In at least one embodiment, two separate input mechanisms may be used, comprising 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 each be a dial, slider, or button.

[0095] In alternative embodiments, any of the probes described herein includes a pressure sensor, which may be located near the distal end of the probe or at another suitable location and coupled to the injection catheter 104. This pressure sensor can be used to acquire intraocular pressure measurement data. The intraocular pressure data can be processed by a processor to warn the user when the intraocular pressure reaches an intraocular pressure limit, at which point further injection of the therapeutic fluid is recommended to avoid any harm to the eye. This pressure limit may be predefined and can be adjusted based on the type of ocular surgery being performed and the health condition of the eye undergoing surgery. For example, the intraocular pressure threshold may be approximately 40 mm Hg, approximately 60 mm Hg, or approximately 80 mm Hg. Intraocular pressure measurements may be based on scleral parameters or other ocular tissue parameters sensed by the device. The device can then instruct the user when the intraocular pressure reaches 40 mm Hg, 60 mm Hg, or 80 mm Hg. Based on the inventors' experience, pressure may increase with injection onto the choroid, causing central retinal artery occlusion or pulsation. In these cases, based on the inventors' experience, the user may perform anterior chamber paracentesis to reduce intraocular pressure. Removing fluid from the anterior chamber can be done slowly and in small increments to avoid bleeding in the posterior segment of the needle insertion site. In some cases, to reduce intraocular pressure, subretinal fluid can be removed slowly, or some of the therapeutic fluid can be removed using this device.

[0096] In an alternative embodiment, robotics can be used in which a robot automatically advances a needle to a desired location using sensor feedback. The robot can receive sensor data such as injection or insertion resistance and use this data to slowly advance the needle. Once the desired sensor value is reached, the robot can begin injection until the desired volume has been injected. The robot can also use sensor data such as intraocular pressure and / or injection resistance to determine when to stop further injection. The surgeon can overtighten the robot at any time to modify the needle position or control the injection of therapeutic fluid.

[0097] In at least one embodiment, device 100 may include a guiding tool that provides guidance based on electrical, mechanical, optical, acoustic, force, pressure, flow, image, or tomographic data. For example, in at least one embodiment, the guiding light tool includes a light source 122 that generates a guiding beam. The guiding tool is optically coupled to the distal end of probe 102 via an optical fiber 120 coupled to port 110. Probe 101 may have an internal optical fiber 109, wherein the proximal end is coupled to port 110 and the distal end is located at the distal end of probe 101 to transmit light from the guiding tool to the distal end of probe 101 (e.g., optical fiber 109 may enter or be adjacent to needle conduit 106c), such that light is emitted at the distal end of probe 101, allowing the user to see the light when examining the patient's eye with an indirect ophthalmoscopy, allowing the user to know whether the needle 106 is located intrascleral, in the SCS, or deeper in the subretinal space. Optical fiber 109 is thin enough that it does not interfere with the injection of therapeutic fluid. The light provided by the optical fiber 109 allows visualization of parts of the eye near the tip of the needle 106, such as the sclera or choroid, enabling the user to more precisely position (i.e., align) the tip of the needle 106 in the appropriate location for injecting the therapeutic fluid. For example, such an optical fiber 109, when emitting light (e.g., illuminating the tip of the needle 106 during use), allows the user to visualize the needle tip internally when the needle 106 is in the suprachoroidal space (or if the needle tip is too shallow in the sclera or too deep in the subretinal space). If the optical fiber 109 is thin, the light intensity may need to be increased to improve visibility. Alternatively, the injection catheter 104 can be used instead of the optical fiber 109 if it is made of a material with sufficient internal light reflectivity. The optical fiber 109 can be replaced by a catheter for different guidance configurations, such as when using non-optically guided tools such as ultrasound imaging devices.

[0098] When visualization is performed using fiber optic 109, the light intensity and / or color may change as the needle tip extends from the sclera into the SCS (and into the choroid, subretinal space, and / or other parts of the eye), providing the user with a visual cue that the needle tip is in the SCS (or in the sclera, choroid, subretinal space, or some other part of the eye). The light intensity may be further altered as the therapeutic fluid is injected. In at least one embodiment, the light transmitted by fiber optic 120 may have a color (other than white) to help the user identify the light during visualization, and the light transmitted by the fiber optic may be referred to as a guide beam. For example, the color may be blue, green, or red. In either white or colored light, when the needle 106 is in the sclera, the colored light will appear internally dim (e.g., attenuated) as it passes through the eyeball / position. As the needle 106 advances through the sclera, the intensity of the colored light will increase or become visible for the first time, which can be recognized by the user to know that the needle has passed through the sclera and is in the choroidal space. The sclera is an opaque tissue and a tightly packed mass of collagen fibers. Therefore, less light is transmitted when it shines from outside or inside the sclera. Furthermore, because the color of light can be modified by the tissue it passes through, the light may appear different when it is inside the sclera compared to when it is in the SCS. For example, the light can change color when it is directly below the choroid compared to when it is inside the sclera. This is because different wavelengths of light may be absorbed differently by the sclera and the SCS (as well as the choroid and retina), and these different wavelengths can be used to distinguish the needle tip's location on the sclera from the SCS (and other locations), where the wavelengths may correspond to, for example, the wavelengths of red, blue, or green light. Users examining the patient's eye using an indirect ophthalmoscopy and condenser lens will be able to see changes in light intensity and / or color. Once the colored light is more clearly seen, which may have occurred when the needle 106 has penetrated the sclera and entered the SCS, the user can initiate the injection.

[0099] In at least one embodiment, the spot size of the guide beam used can range from approximately 50 micrometers to approximately 500 micrometers, and the intensity of the beam can be selected such that changes in the optical properties are visible to the human eye and / or detectable by a light sensor. In at least one embodiment, in addition to the optical fiber transmitting white light for observation / imaging, an optical fiber for transmitting the guide beam may also be provided. The white beam can be larger and can be provided by an optical fiber coupled to the distal end of probes 101, 201.

[0100] It should be noted that the light intensity may also change when the needle tip is pointed perpendicularly into the sclera (e.g., the light intensity may be highest in this case). Alternatively, if the beam consists of polarized light, a light polarization-sensitive sensor can be used to ensure that the needle tip is oriented perpendicularly to the needle insertion made in the sclera.

[0101] Therefore, in at least one embodiment, by using a light sensor to sense any reflected light to obtain reflected light data and using a processor to analyze the reflected light data, any changes in the optical properties of the light beam transmitted to the eye via the probe can be detected, where the optical properties can be intensity, wavelength (e.g., color), and / or polarization. Changes in optical properties can be transmitted to the user via the processor. For example, the sensor can be used to sense backscattered or reflected light of a certain wavelength to know when the needle has passed through the sclera. When the needle is in the sclera, the reflectivity of the light returning to the sensor may be different from when the needle has passed through the sclera and entered the SCS.

[0102] Alternatively, in at least one embodiment, the guiding tool may be an imaging and / or measuring device 122, such as an optical coherence tomography (OCT) device. The guiding tool is optically coupled to the distal end of the probe 102 via an optical fiber 120 coupled to port 110. The probe 101 may have an internal optical fiber 109 coupled to port 110, or the injection catheter 104 may be used to: (a) transmit light from the OCT device to the distal end of the probe 101 such 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 reflected light from this area of ​​the patient's eye to the OCT device 122, which can then generate and display an OCT image based on the reflected light. The user can observe the OCT image to more precisely position (i.e., align) the tip of the needle 106 in the appropriate location for injecting the therapeutic fluid. In at least one embodiment, OCT images can be used to ensure vertical alignment by measuring the thickness of the sclera and adjusting the probe angle to reduce (i.e., preferably minimize) the scleral thickness, which indicates the vertical intersection (i.e., the shortest path) of the needle insertion rather than an angled path.

[0103] It should be noted that, in at least one embodiment, other light-guiding tools such as optical coherence elastography (OCE) devices, endoscopic imaging devices, light intensity sensing devices, light scattering sensing devices, light wavelength sensing devices, or light polarization sensing devices can be used. In the case of endoscopy, the use of a light camera allows the user to observe the location of the needle tip on a monitor. This also allows the user to see the scleral fibers and know, for example, when the needle tip is in the SCS.

[0104] It should be noted that, for the various optical imaging devices described herein, this implementation may involve the use of a flexible optical fiber (or other "light guide") bent to emerge from the side of the distal end of the probe, or in some cases, a forward-facing imaging tool may be used with a 45-degree mirror, such that the tool generates an image with the field of view perpendicular to the longitudinal axis of the distal end (i.e., toward the eye), into which the needle will pass during use rather than with a tip pointing toward the distal end.

[0105] It should also be noted that various optical imaging devices within the probe and one or more sensors described herein can be analyzed to determine positional data indicating the location of the probe tip during use. The combination of imaging devices and one or more sensors can provide an assessment of whether the needle is within the sclera or whether the needle has completely penetrated the sclera and is in space above the choroid. For example, needle depth penetration (or needle penetration depth) can be determined by matching the optical, mechanical, electrical, or other outputs of the imaging devices and sensors with different characteristic values ​​of different types of eye tissue. Needle depth penetration can also be determined by counting the number of changes in the output measurements, where each change indicates that the probe has entered from one tissue type to another, and this is correlated with the known tissue layer anatomy of the eye. Generally, needle depth penetration can be determined based on the location of the imaging devices and / or sensors, and the position of the needle tip can be calculated relative to a reference position based on the known (calibrated) physical configuration of the probe elements. Needle depth penetration data (i.e., positional data) can be displayed by the control unit 250 or transmitted to the user in other ways, such as through audio feedback.

[0106] In another alternative, in at least one embodiment, the guiding tool may be an imaging device 122 such as an ultrasound (US) imaging device. The guiding tool is connected to the distal end of the probe 102 via a wire or cable 120 connected to port 110. The probe 101 may have internal wires connected to port 110 and a US transducer disposed near the distal end 103 of the probe 101. The US transducer may emit sound waves 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) the US waves reflected from this area of ​​the patient's eye are then received by the US transducer, which converts them into corresponding electrical signals transmitted to the US imaging device 122, which may then generate and display a US image based on the reflected US waves. The user can observe the US image to more precisely position (i.e., align) the tip of the needle 106 in the appropriate location for injection of the therapeutic fluid. Additionally, in at least one embodiment, US data / US images may be used to align the needle such that the needle enters the sclera approximately perpendicularly.

[0107] The therapeutic fluid obtained from therapeutic fluid source 116 can be, for example, a viscoelastic agent, such as hyaluronic acid, that can have an active period (lasting) of several weeks (2 to 8 weeks). For example, sodium hyaluronate 2.3, which can have an active period of approximately 2 to 3 weeks, can be used. However, a more durable therapeutic fluid, such as "crosslinked" hyaluronic acid or other modified hyaluronic acid, may be preferred. For example, Restylane, which can be effective for several months, can be used. Alternatively, absorbable and inert / non-inflammatory compounds can be used for the therapeutic fluid. For example, 1% to 2.3% sodium hyaluronate, Restylane, or hydrogel spacers (soluble or insoluble) can be used.

[0108] In an alternative embodiment, the treatment fluid may contain an inert gas or air.

[0109] It should be noted that in at least one alternative embodiment of device 100, the fluid actuator 112 may be provided by the plunger of the syringe, and the source of the therapeutic fluid may be contained in the barrel / chamber of the syringe. In this case, a person assisting the user may actuate the plunger to administer the injection.

[0110] In another alternative embodiment, the injection catheter 104 may be pre-loaded with therapeutic fluid, or a therapeutic fluid source may be incorporated into the injection catheter, so that the device does not need to be connected to an external therapeutic fluid source. In such cases, the fluid actuator 112 can still be used to apply injection pressure in a similar manner to that previously described, allowing the user to use one hand exclusively for operating the probe 101.

[0111] Now for reference Figure 2A The diagram illustrates another example embodiment of a probe 201 for an ocular treatment device 200 for treating retinal tears or RRDs or for delivering therapeutic fluids to the eye, as taught herein. Probe 201 shares some similarities with probe 101 and therefore has similarly numbered components that operate in a similar manner and are not discussed in detail, as they have already been discussed with respect to probe 101. However, probe 201 also has additional components that allow the user to aspirate fluids (actively or passively) from the patient's eye, such as suprachoroidal fluid or hemorrhage or subretinal fluid (SRF) or subretinal hemorrhage, or some of the injection fluid when too much fluid is injected, which may need to be done on a patient-by-patient basis. For example, probe 201 includes a dual-catheter design comprising an outlet catheter for draining fluids such as subretinal fluids from, for example, an ocular region, and an injection catheter for delivering therapeutic fluids, as previously described with respect to probe 101, for injection into the patient's eye into the SCS to treat RRDs or retinal tears (or for injection into different locations to treat different conditions). The discharge catheter can be fluidly connected to a discharge tube inside or outside the probe and to store the discharged fluid.

[0112] In an alternative embodiment, a probe is provided that can use a single conduit, which can be used as both an injection conduit and a removal conduit at different times, provided that any discharged fluid is removed from the probe and does not interact with any injected fluid. In some cases, discharge may be performed first, followed by injection, or in other cases, fluid injection may occur first, followed by discharge at the same location or elsewhere. In such embodiments, a valve or gate may be used to fluidly connect the single conduit to a fluid source or discharge container when injection and discharge are performed separately. Thus, in at least one embodiment, an injection fluid container and / or a discharge fluid container are connected to one or more probe conduits.

[0113] Figure 2A The probe 201 is shown to have a dual-cylinder design, wherein an inner cylinder is surrounded by an outer cylinder, and one cylinder serves as an injection catheter, while the other serves as an discharge catheter. Therefore, as illustrated with respect to probe 101, probe 201 includes a cylinder that acts as an injection catheter 104, and may be pre-loaded with therapeutic fluid in a fluid cylinder that can be coupled to the injection catheter 104. In at least one embodiment, probe 201 may include a plunger 211 having a shaft 213 slidably received within a port 212 of the injection catheter 104. The plunger 211 has a thumb rest 215 that can be pushed by a user when injecting therapeutic fluid. The user can then push the thumb rest 215 to inject the therapeutic fluid.

[0114] Alternatively, probe 201 may not include plunger 211, but instead use a component similar to that used in probe 101 in device 100 (e.g., fluid actuator 112, pump(s)). Figure 1 Not shown in the image, but the example is... Figure 2C The pump 280 and pipes 114 and 118 are used to inject the therapeutic fluid. Alternatively, in at least one embodiment, such as Figure 2B and Figure 2C The hardware configuration of the control unit 250 shown herein can be used with any of the probes described herein for actuating the injection of therapeutic fluid into a patient's eye, in which case the control unit is separate from the probe (e.g., not housed in the probe or placed with the probe). In such a design, the connection for supplying therapeutic fluid to the injection catheter 104 may be via port 212, or alternatively, port 212 may be absent, and the end of the injection catheter 104 is sealed, while a side injection port 216 is used to supply therapeutic fluid to the injection catheter 104. Thus, port 216 may be optional in some embodiments, or port 212 may be optional in other embodiments. However, there may be embodiments in which the control unit is housed within the probe (e.g., see...). Figure 3H(Independent probes / devices in the system).

[0115] In at least one embodiment, probe 101 may include one or more resistance sensors 107 located on the underside of a stop 214 at the distal end of the plunger 212, adjacent to the treatment fluid. Alternatively, in some embodiments, such as those that do not include a plunger 212, the resistance sensors (one or more) 107 may be located in the needle catheter 106c, such as near the distal end of the needle catheter 106, as described for probe 101. The resistance sensors (one or more) 107 operate as described for probe 101.

[0116] For example, the outer cylinder can act as an outlet conduit 228 for draining fluid, such as subretinal fluid, from a portion of the patient's eye. The needle 106 has a needle position adjustable between an outlet position and an injection position. The outlet position allows the outlet conduit 228 to be fluidly connected to the needle conduit 106c to drain fluid from the subretinal space of the eye, while the injection position allows the injection conduit to be fluidly connected to the needle conduit to inject therapeutic fluid into the subretinal space of the eye. When the needle position is in the injection position (this position is as follows...), Figure 2A As shown in the diagram, the circumferential aperture 224 (e.g., a small orifice) is positioned to coincide with the injection catheter 228. When the needle is in the discharge position, the needle 106 advances such that the tip of the needle 106 extends further away from / beyond the distal end 103 of the probe 201, which advances the position of the circumferential aperture 224 so that the circumferential aperture is positioned to coincide with the discharge catheter 228. Therefore, the aperture 224 and the element of moving the needle 106 can serve as a connector that can be adjusted between fluidly connecting the discharge catheter to the needle catheter and fluidly connecting the injection catheter to the needle catheter.

[0117] The position of needle 106 is controlled by needle actuator 108, as previously described for probe 101. Figure 2AIn this embodiment, the needle actuator 108 is connected to a slider mechanism 220 or other suitable mechanism to advance or retract the tip / end portion of the needle 106. Alternatively, a rotary dial can be used instead of the slider 220. In either case, a gear assembly can be used to convert larger movements of the slider or dial into smaller movements of the extendable needle 106, allowing the user more precise 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 a linear manner as the needle 106 extends and retracts outside the distal end of the probe 201. For example, when the needle is in the injection position, the tip of the needle 106 may extend from approximately 0.3 mm to approximately 1.5 mm for a first SCS injection, or from approximately 1 mm to approximately 2 mm for a second SCS injection (as previously described). For example, the needle actuator 108 can be implemented with incremental steps corresponding to incremental changes in the depth at which the tip of the needle 106 enters the patient's eye, such as, but not limited to, incremental steps corresponding to 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm and 1.5 mm or other suitable distance movements.

[0118] However, for probe 201, the needle position can be changed to a discharge position, in which case the tip of needle 106 can extend approximately 1.5 mm to approximately 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 discharge (e.g., it can vary depending on the thickness of a specific ocular layer, such as the sclera, which can vary for different individuals) can also vary. However, if there is more bullous retinal detachment, the tip of needle 106 can be advanced slightly further, while if the retina has a shallow detachment, a shorter needle length can be used for discharge. For example, the needle length can vary in small increments, such as, but not limited to, 0.1 mm, allowing the needle to extend or retract slowly as previously described. For example, the needle tip can be advanced slowly until it passes through the retinal pigment epithelium and enters the subretinal space, and when discharge is complete and the retinal detachment height decreases, needle 106 can be retracted to avoid contact with the retina. Fluid discharge can be passive (where higher-pressure fluid in the eye drains naturally into a lower-pressure discharge conduit) or active, in which case suction is used. For example, the fluid actuator 112 and the pump can be coupled to the discharge conduit 228 via port 210 and operate in reverse, so that instead of applying an injection pressure, the fluid actuator 112 applies a negative discharge pressure (e.g., aspiration). In at least one embodiment, the control unit 250 can alternatively be used to provide active discharge. Thus, in various embodiments, there is a pump fluidly coupled to one or more probe conduits, which is controllable to generate an injection pressure when fluid is injected into the eye, or a discharge pressure when fluid is expelled from the eye.

[0119] The inventors also discovered that, in order to achieve good results in repairing eyes with retinal detachment or retinal tears, it may be necessary to drain fluid from the eye in some cases. Fluid drainage can be performed on fluid in the subretinal space (approximately 1.5 mm to 3 mm depth). Subsequently, the needle position can be changed to the injection position, where the needle 106 retracts to a shorter length (i.e., a shallower depth into the patient's eye) and then the therapeutic fluid is injected into the SCS. This can be performed as a two-step procedure, where the drainage of eye fluid (from the subretinal space) and the injection of therapeutic fluid (in the SCS) can have different locations, but in some cases, this drainage and injection can be at the same location where the retinal tear is located. However, in some cases, drainage near a large retinal tear is not desirable, as this may drain vitreous fluid instead of subretinal fluid. In cases with larger tears, particularly in areas with more bullous retinal detachments, the user can choose an alternative location to drain the subretinal fluid.

[0120] The probe 201 includes a port 222 for receiving a portion of a guide tool to assist the user in properly positioning the tip of the needle 106 during ejection or injection. This guide tool is similar to the guide tool described above for device 100. Therefore, when the guide tool includes a light source, port 222 can receive an optical fiber that can be coupled to an internal optical fiber 109 to illuminate the tip of the needle 106 during use. Alternatively, when the guide tool includes an OCT imaging system (or any other previously described imaging system), port 222 can be used to connect to an OCT imaging system (or any other previously described imaging system). Alternatively, the guide tool can be an ultrasound imaging device, in which case port 222 can be used to connect 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 illustrated with respect to probe 101.

[0121] Now for reference Figure 2B and Figure 2C The diagram shows a front view of an example embodiment of control unit 250 and a block diagram of the electrical components of control unit 250, respectively. Control unit 250 can be used with any of the probe embodiments described in accordance with the teachings herein to assist a user in performing ST technology or another ophthalmic surgery / treatment. For example, control unit 250 can be used with probe 201 to form an embodiment of an ophthalmic treatment device. Alternatively, control unit 250 can be used with probe 101 when operating only in injection mode. Control unit 250 can be used to perform certain functions such as, but not limited to, controlling discharge, controlling injection, instructing the user on certain operating parameters, displaying visual guidance to the user using a guiding tool, and providing feedback prompts to the user in any combination of these functions. In at least one embodiment, control unit 250 can be used to control needle insertion / retraction by processing any combination of sensor signals and imaging data to extend the needle to the desired injection site and retract the needle as desired during the procedure. The control unit 250 is connected to an actuator control input 262, such as a pedal, switch, slider, rotary dial, etc., which the user can use to perform injection or drainage while allowing at least one of their hands to freely hold the probe 201 in a precise position. It should be noted that the control unit 250 can also be used with the probe 101, in which case the control unit is not needed when the probe 101 is not performing drainage. Figure 2B and Figure 2C The components related to discharge are shown in the diagram. It should be noted that the components and their positions on the control unit 250 are provided as examples only and may differ in other embodiments.

[0122] 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 switch with an injection position and an expulsion position, a separate switch for selecting an injection mode and an expulsion mode, or other suitable input / control element. A user can push the on / off button 252 to switch the control unit 250 from off to on or from on to off. A user can use the injection operation button 254 to switch the control unit 250 to the injection operation mode to inject the therapeutic fluid into the patient's eye via probe 201 or 101. A user can use the aspiration operation button 256 to switch the control unit 250 to the aspiration operation mode to expel fluid from the patient's eye via probe 201.

[0123] The control unit 250 also includes an injection port 258 to receive an external injection conduit connected to an injection catheter 104 of probe 101 or 201. The injection port 258 is internally connected to an internal injection catheter (e.g., an internal conduit) that is connected to a pump 280 for generating injection pressure during injection. The pump is fluidly coupled to a therapeutic fluid source to deliver therapeutic fluid to the injection port 258 via the internal injection catheter. The control unit 250 also includes a discharge port 260 to receive an external aspiration conduit connected to a discharge catheter 228 of probe 201. The port 260 is internally connected to an internal discharge catheter (e.g., an internal discharge conduit) that is connected to the same pump 280 or a different pump for generating aspiration pressure during discharge. Pump 280 operates in response to a user engaging actuator control input 262 in the open position. Pump 280 is fluidly connected to a discharge container (e.g., a discharge fluid container) that receives the discharged fluid during use.

[0124] The actuator control input 262 sends an actuator control signal, which is received by the processor 270 of the control unit 250. This, in turn, generates a pump control signal to operate the pump 280 according to either an injection mode or an aspiration mode. In injection mode, the processor 270 is configured to send a pump control signal to the pump 280 to generate an injection pressure at a preset injection pressure level to move the therapeutic fluid from the therapeutic fluid source to the SCS of the patient's eye. For example, the preset injection pressure may be in the range of approximately 20 mm Hg to approximately 80 mm Hg, such as 50 mm Hg. In aspiration mode, the processor 270 is configured to send a pump control signal to the pump 280 to generate an aspiration pressure at a preset aspiration pressure level to move the aspiration fluid from the patient's eye to an aspiration container. For example, the aspiration pressure may be preset in the range of approximately 0 mm Hg to 700 mm Hg or from approximately 100 mm Hg to approximately 650 mm Hg.

[0125] Control unit 250 may include display 264 for displaying / showing various information to a user. For example, display 264 may be used to display insertion resistance measured during operation, injection pressure used during injection mode, and aspiration pressure used during aspiration mode. Depending on the probe embodiment described herein, other measurements performed during operation may be displayed, such as the light intensity, wavelength, and / or polarization of any reflected light from the eye to the probe. In the case of measuring injection resistance, there may be wires / cables connecting the resistance sensors in probes 101, 201 to an interface in control unit 250 accessible to processor 270. Alternatively, in at least one embodiment, the connection between the probe and control unit 250 may be wireless. In at least one embodiment, display 264 may be a touch-sensitive screen that a user can use to operate control unit 250; in this case, because the user can select these modes by touching display 264, injection operation button 254 and aspiration operation button 256 can be omitted.

[0126] In at least one embodiment, when using a guiding tool such as optical guidance, OCT imaging, and / or US imaging, the control unit 250 may include a guiding tool port 266. In the case of optical guidance, port 266 may be used to receive an external optical fiber connected to probe 101 or 201 and is internally connected to an internal light source. In the case of optical coherence tomography or other optical imaging devices previously described, port 266 may be used to receive an external optical fiber connected to probe 101 or 201 and is internally connected to an OCT device (or other optical imaging devices previously described) that may be inside or outside the control unit 250. In the case of US imaging, port 266 may be used to receive a cable that is ultimately connected to a US transducer in probe 101 or 201 and is internally connected to a US imaging device that may be inside or outside the control unit 250. When the guiding 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 to a display 264.

[0127] When the guiding tool is light-guided and the display 264 is a touch-sensitive display, the user can adjust the intensity or wavelength of the light generated by the light source. Alternatively, in embodiments where the display 264 is not touch-sensitive, a physical slider control (not shown) can be used for the same purpose. The light source can be an LED that generates white light, and an LED driver can be used to control the intensity of the generated white beam. During use, the light intensity can be controlled via calibration settings and / or user control. In at least one embodiment, the light source can include an LED capable of generating a colored beam, as previously described. In at least one embodiment, the light source can include two LEDs with two LED drivers, one LED generating white light and the other LED generating colored light. Optics can be used to make the colored beam smaller and positioned within the white beam.

[0128] In at least one embodiment, the control unit 250 may include a speaker 268, which can be used to output voice indicating one or more operating parameters and / or operating modes of the control unit 250. Thus, when a user selects an injection mode or an aspiration mode, voice audio can be output through the speaker 268 to instruct the control unit 250 to operate in the injection mode or aspiration mode, respectively. Furthermore, any of the measured injection resistance, injection pressure, and aspiration pressure can be indicated in the voice audio output through the speaker 268. In the case of outputting measured insertion resistance, this can be done when the user inserts the needle 106, and the measured insertion resistance changes by an amount such as between 10% and 20%. Alternatively, depending on the circumstances during operation, such as when the needle tip penetrates too deeply or reaches its intended destination based on any sensing technology described herein, other sounds such as tone or beeping can be transmitted to the user.

[0129] Refer again Figure 2C , which shows Figure 2B A block diagram of an example embodiment of the components of control unit 250. 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 of 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. Memory unit 272 includes random access memory (“RAM”) and non-volatile memory configured to store program / software instructions for operating system 288, program 290, control application 292, I / O module 294, and file 296. Figure 2C The components and their organization shown are examples and may differ in other embodiments. The power supply unit 287 provides power to the various components of the control unit 250.

[0130] Processor 270 controls the operation of control unit 250 and may include any suitable processor, control, or digital signal processor that can provide sufficient processing power based on the configuration, purpose, and requirements of control unit 250 known to those skilled in the art. For example, processor 270 may include a high-performance general-purpose processor. In alternative embodiments, processor 270 may include more than one processor, each configured to perform different dedicated tasks. In alternative embodiments, dedicated hardware may be used to provide some of the functions provided by processor 270.

[0131] Display 264 can be any suitable display device that outputs visual information. For example, display 106 can be an LCD or LED, or a touch screen. Display 264 can provide notifications and display measured values, operating parameters, and / or guide images based on the components / functions of control unit 250. For example, processor 270 can be configured to display operating parameters, such as measured resistance, injection pressure, and / or aspiration pressure, on display 264.

[0132] User interface 274 enables a user to provide input to 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, if control unit 250 includes a light source for visual guidance, the input device may be a slider, button, lever, dial, or wheel that can be used to adjust the light intensity.

[0133] Device interface 276 may include a communication port, network interface device, analog-to-digital converter (ADC), or digital-to-analog converter (DAC), wherein the communication port includes any combination of at least one serial port, at least one parallel port, and at least one USB port providing USB connectivity. Device interface 276 is used to communicatively connect processor 270 to various devices, allowing processor 270 to send and receive signals with these other devices, such as one or more sensors 278 or actuator control inputs 262, whether internal or external to control unit 250. Therefore, device interface 276 may be adapted to receive measurement data and transmit control signals for device operation.

[0134] In at least one embodiment, the control unit 250 may include a communication unit that may contain a radio for wireless communication using CDMA, GSM, GPRS, or Bluetooth protocols according to standards such as IEEE 802.11a, 802.11b, 802.11g, or 802.11n or other wireless communication protocols. The control unit 250 may use the communication unit to communicate with other devices, computers, or probes having corresponding radios. Therefore, the communication unit can provide the control unit 250 with a means of wireless communication with various devices that may be located remotely from the control unit 250.

[0135] For example, one or more sensors 278 may include a resistance sensor 107, such that the measured resistance value can be received via an ADC and analyzed by a processor 270. Similarly, actuator control input 262 may generate an analog signal that is converted into a digital signal by an ADC in device interface 276 and can be received and processed by processor 270. As another example, processor 270 may generate a digital pump control signal in response to receiving an actuator control signal, and this digital pump control signal may be converted into an analog signal via a DAC in device interface 276 and sent to one or more pumps 280.

[0136] In another example, speaker 268 may be communicatively coupled to the processor via a DAC in device interface 276, and processor 270 is configured to generate and output audio signals via speaker 268, wherein the audio signals include speech, tone, or beeping sounds corresponding to operating parameters and / or measurement data, and the measurement data includes measured resistance, injection pressure, and / or suction pressure. Alternatively, or in addition, in at least one embodiment, a vibrator may be included in control unit 250 and, as previously described, for conveying certain operational information to the user, such as the position of the needle tip relative to a desired location in the eye.

[0137] In another example, in an embodiment where the control unit 250 includes a light source (various example implementations of which have been previously described), the device interface 276 may include an optical port coupled to the light source 282 via an internal optical guide (e.g., an optical fiber). This then allows the light source 282 to be coupled to an external optical fiber connected to the optical port and probe 101 or 201.

[0138] In another example, in an embodiment where the control unit 250 includes an OCT device 284 or other optical imaging device as previously described, the device interface 276 may include an optical port for receiving an optical fiber optically coupled to an optical guide at probe 101 or 201, and the control unit 250 may include an internal optical guide optically coupled to the optical port and the OCT device 284 or other optical imaging device. In such embodiments, OCT measurements generated by the OCT device 284 or images generated by other optical imaging devices can be output to a display 264 under the control of the processor 270.

[0139] 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 disposed at the distal end of the probe 101 or 201, the device interface 276 may include an electrical port for receiving a cable connected to the US transducer and for transmitting a US signal generated by the US transducer. This port is connected to an internal line connected to a US imaging device that receives the US signal and processes the received ultrasound signal to generate a US image. In such embodiments, the US image generated by the US device 286 may be output on a display 264 under the control of the processor 270. Alternatively, or in addition, the control unit 250 may include a transducer for generating an acoustic signal and / or an acoustic reflection measuring device for receiving acoustic reflection measurements, processing the received acoustic reflection measurements, and displaying the processed acoustic reflection measurements on the display 264, and the device interface 276 may include an acoustic port for connecting the acoustic signal, and the probe 101 or 201 may include one or more acoustic waveguides.

[0140] As those skilled in the art will know, depending on the implementation of control unit 250, power supply unit 287 may be a power adapter or a rechargeable battery pack. In some cases, 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 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 various components of control unit 250. In other embodiments, power supply unit 287 may include other components known to those skilled in the art for providing power or backup power.

[0141] Memory unit 272 includes volatile storage devices and non-volatile storage devices such as ROM, one or more hard disk drives, one or more flash drives, and / or some other suitable data storage elements. The non-volatile storage devices can be used to store software instructions containing computer-executable instructions for implementing operating system 288, program 290, control application 292, and other software modules, as well as storing any data used by these software modules. Operating system 288 and program 290 may contain software instructions for performing basic operations and functions of processor 270 and control unit 250. Data may be stored in file 296, such as data related to operating parameters of control unit 250 and any images when using OCT device 284 or US imaging device 286. Control application 292 contains software instructions for providing the various functions of control unit 250 described herein. Processor 270 is configured to perform these functions when processor 270 executes the software instructions of control application 292. I / O (input / output) module 294 contains software instructions that, when executed by processor 270, can configure processor 270 to store data in file 296 and / or retrieve data from file 296.

[0142] In at least one embodiment, in one application, the distal end of probe 101 or 201 may be positioned posteriorly in the macular region and used to place the choroidal (and / or macular) cingulates to treat myopic macular holes and / or myopic traction macular degeneration. However, this may require incising the conjunctiva to access this region. For example, the conjunctival incision may be made in the temporal inferior quadrant of the eye under local anesthesia. The septum may also be minimally incised. One of the probes described herein can then be accessed from the posterior end to reach the macular region. Once the probe is internally visualized as pressing on the macular region, a therapeutic fluid can be injected into the suprachoroidal space to generate the temporal choroidal cingulates in this region. In at least one embodiment, one of the probes described herein can be used to deliver certain treatments, such as gene therapy or other drug solutions or drugs on a sustained-release platform / hydrogel, to the subretinal space of the macular region.

[0143] In at least one embodiment, any of the devices described herein may be used alone in a clinic or operating room (or), or: a) in combination with vitrectomy, b) in combination with a chandelier for visualization, and then with placement of a choroidal buckle, c) in combination with pneumatic retinal fixation (in an office or operating room) to supplement the role of the bubble or to resolve lower tears or holes that cannot be adequately resolved by the bubble due to patient position limitations, and / or d) in combination with conventional scleral buckling, wherein ST surgery can be performed as an adjunct to an already placed scleral buckle, and can be performed simultaneously or later as a resuscitation procedure if the primary scleral buckling is ineffective. This procedure may also be used as an adjunct to vitrectomy in the presence of an iatrogenic retinal tear.

[0144] In at least one embodiment, the injection catheter 104 of probe 101 or 201 can be filled with liquid nitrogen for performing cryofixation to repair retinal tears / detachments. Alternatively, additional injection catheters can be added to probe 101 or 201 for cryofixation, while another injection catheter can be used to inject the therapeutic fluid. Currently, without cryofixation, once the retina is reattached after the therapeutic fluid is injected into the SCS, the patient requires laser retinal fixation in the following days to form permanent choroidal-retinal adhesions between the retina and the retinal pigment epithelium surrounding the retinal tear. Alternatively, in probes incorporating cryofixation, the probe can be used to first perform cryofixation, then perform subretinal fluid drainage if necessary, followed by injection of the therapeutic fluid into the SCS. This may have the advantage that the patient may not require any further treatment for their retinal detachment, advantageously requiring only one treatment session for the procedure without subsequent sessions for further treatment.

[0145] In at least one embodiment, the injection catheter 104 of probe 101 or 201 may contain an inert gas or air that can be injected intravitreally by extending a needle into the vitreous body. Alternatively, additional injection catheters may be added to probe 101 or 201 for intravitreal injection. Thus, the same probe can be used in conjunction with the ST method in combination with pneumatic retinal fixation. For example, intravitreal injection may be performed approximately 4 mm posterior to the limbus, which is the pars plana of the ciliary body and where it is safe to perform intravitreal injection.

[0146] Currently, conventional devices for suprachoroidal (or subretinal) drug delivery largely rely on scleral incision and then inserting a probe / cannula through the suprachoroidal space to the desired target location before opening the injection site. Some of these devices rely on injecting the drug into the anterior portion of the suprachoroidal space, with the expectation that the drug will dissipate / diffuse from the suprachoroidal space to the target site. However, no conventional device allows direct penetration of the sclera at the posterior target location, or has a needle that can retract during device positioning and then variably (and controllably) extend to the desired depth. One problem preventing direct penetration of the sclera is that, in typical designs of conventional devices, the needle typically extends from the distal tip of the distal end of the device along (i.e., parallel to) the longitudinal axis of the distal end of the probe, making it difficult to orient a conventional probe correctly and insert it into the sclera at the correct angle and in an appropriate manner (e.g., approximately perpendicular or at any desired angle).

[0147] However, this challenge is overcome by various probe embodiments described according to the teachings herein, wherein, in a first aspect, the lateral surface of the distal end of the probe is preferably bent with a radius of curvature similar to that of the eye (e.g., sclera) into which the needle is inserted. Since the target location for insertion can be in different parts of the eyeball, distal end bends with different arc angles and radii of curvature can be used, such that a needle exiting from the exit position of the bent lateral surface of the distal end of the probe inserts into the sclera at approximately 90 degrees, allowing for precise positioning of the target insertion location. For example, for applications such as retinal detachment repair or drug delivery, more anterior target locations at the vitreous base or equator will require a smaller distal end probe length and a corresponding arc angle, such as approximately 10 to approximately 15 degrees (or greater or less, in which case probes with longer or shorter distal ends can be used). However, for more posterior drug delivery, such as near the macula, larger arc angles, such as approximately 60 to approximately 75 degrees, may be preferred for the distal bend of the probe to allow the device to be properly positioned on the scleral surface.

[0148] In a second aspect, the distal end portion of the probe described according to the teachings of this document may have an approximately flat profile of the surface of the distal probe end from which the needle extends, such that this probe surface is tangent to the scleral surface at the point of needle entry.

[0149] In a third aspect, the needle at the distal tip of the probe, as described in this teaching, can extend approximately perpendicular to the longitudinal axis of the distal end portion from a position on a lateral surface of the distal end portion of the device, allowing the needle to be inserted approximately perpendicular to the scleral surface. For example, the needle can extend at a position on a curved surface of the distal end portion of the probe or at the tip of the probe. In either case, the needle can extend from the eye-facing curved surface of the distal end portion of the probe, such that the curved surface of the distal end portion of the probe can be positioned along the curvature of the eye, and the needle can enter the sclera perpendicular to the tangent of the eyeball at that position. Advantageously, this reduces / minimizes the distance the needle must travel to reach the desired target location in the eye, thus reducing the risk of complications such as bleeding. Furthermore, the predictable straight path followed by the extended needle, perpendicular to the tangent of the sclera, allows for more predictable needle depth penetration, advantageously increasing the chance of the needle tip being in the correct position and depth (e.g., depending on the subretinal or suprachoroidal space of the ophthalmic surgery being performed).

[0150] In some embodiments, the probe and needle can be configured such that the needle enters the sclera at an angle that is not approximately perpendicular to the sclera at the point of entry. Such a configuration may be preferred in some cases to allow the needle tip to enter the SCS at an angle, so that it will travel a longer distance to traverse the SCS and is therefore less likely to inadvertently traverse the SCS and penetrate the choroid.

[0151] In at least one embodiment, having one or more of the previously described sensing mechanisms will allow the needle tip to be accurately and precisely positioned at the desired target location from the external scleral position. Furthermore, sensing mechanisms such as, but not limited to, beam and / or resistance sensors (which may be implemented using pressure sensors, flow sensors, and / or resistance sensors) also guide the needle from the lateral surface of the distal end portion of the probe relative to the scleral surface in the same direction as the needle.

[0152] Now for reference Figure 3AThis document illustrates several embodiments of the distal end portions of probes 300a, 300b, and 300c according to the teachings herein, wherein the curved distal end portions have different arc angles and arc lengths for positioning at different locations on the eye. Each of probes 300a-300c has curved distal end portions 302a-302c such that the lower surfaces 304a-304c of probes 300a-300c (i.e., the probe surfaces facing the sclera during use) have radii of curvature corresponding to the eye region where the entry point must be precisely determined, such that the curved distal end portions are placed in close contact with the scleral surface and have different angles between a first longitudinal axis of the probe body and an approximate second longitudinal axis of the curved distal end portions, and optionally, different lengths of the curved distal end portions are used to achieve different scleral positions. For example, the radius of curvature of the distal end portions 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 approximately 15 mm at the distal curved portion. Using probe 300a, this curved section is the lower surface of the distal curved portion indicated by reference numeral 304a. The arc length is the length of the arcuate portion of the distal end portion and is shown as 304L. The arc angle is the angle indicated by β. The dashed pie chart is for illustrative purposes only and indicates the arc angle and arc length characteristics of the distal end portion of the probe. The arc angle of the distal curved end portion of probe 300a can be approximately 60 degrees, the arc angle of the distal curved end portion of probe 300b can be approximately 30 degrees, and the arc angle of the distal curved end portion of probe 300c can be approximately 15 degrees. Using probe 300a, the longitudinal axis A1 of the probe body and the longitudinal axis A2 of the curved end portion have an angle α (e.g., ...). Figure 3A (The positioning shown in the figure) illustrates how the end portion bends away from the longitudinal axis of the probe body.

[0153] It should be noted that the surface of the distal end portion of the probe faces the eye during normal operation and the needle protrudes from this surface, which may be referred to as the inner surface, lower surface, concave surface, side surface, or any similar term herein.

[0154] As described above, the probes 300a-300c and the curved distal end portions 302a-302c have different arc lengths to allow the needle to be positioned in different target areas on the eyeball. Therefore, the distal end portions have predetermined radii of curvature and lengths for reaching desired locations on the eye surface during use. For example, a distal tip portion with an arc angle of approximately 10 to 20 degrees can be used for anterior ocular positions, while an arc angle of 20 to 40 degrees can be used for mid-peripheral positions, and an arc angle of approximately 50 to 70 degrees can be used for more posterior regions such as the macula.

[0155] Now for reference Figure 3BThe figure is an enlarged view of probe 300a. It should also be noted that each probe 300a to 300c may include bosses 308a to 308c on the lower surface of the distal end portion from which the needle extends. One or more sensing elements may be directed from the bosses toward the scleral surface for various purposes, such as for precise depth determination during use. For example, a guide beam may be emitted from the bosses (see, for example, see...). Figure 4E (463 in the original text). Alternatively, embodiments may exist in which the protrusion is not used, but the needle and one or more sensing elements are located on the lower surface of the probe in a similar manner. The protrusions 308a-308c, also referred to as protrusions, protrusions, or lumps, can be used to press into the sclera during the positioning of the target injection area, so that the probes 300a-300c can be accurately positioned on the area of ​​the scleral surface of the eye to be injected. However, indentation of the eye surface can still be performed when the protrusion is not used. According to embodiments, during use, the needle can extend beyond the protrusion or a location adjacent to the protrusion. Thus, the side surface of the probe has a protrusion at the exit position, and the needle is configured to extend and retract through the protrusion, or the side surface has a protrusion adjacent to the exit position, and the needle is configured to extend and retract adjacent to the protrusion. It should be noted that in the various embodiments, any probe described herein may have Figures 3A to 3B The shape of probes 300a-300c is shown in the diagram. Therefore, the boss can be used as a visual indicator of where the needle will extend. The size of the small piece can be selected such that it covers the size of the needle used. For example, when using a 30G needle, the boss can have a diameter in the range of approximately 0.5 mm to 1.5 mm.

[0156] In at least one embodiment, a force sensor may be included in the boss to provide the user with force feedback on how much force the user applies to the surface of the sclera when the needle is extended into the eye. The user can use this force feedback to avoid applying too much force during needle extension, which could otherwise cause scleral indentation and result in a deeper penetration than desired.

[0157] In at least one embodiment, the boss can be used to provide more space for accommodating the needle and one or more sensors without changing the thickness of the entire distal probe end.

[0158] In at least one embodiment, the boss may be movable or vibrating during use, and this can be used to help identify the location of the distal end portion of the probe and where the needle will extend from the probe during use. For example, the boss may move in a reciprocating / oscillating manner at a certain frequency (e.g., rhythmically), and this movement is visible inside the eye, thereby aiding in the visualization and identification of the location of the curved distal end portion of the probe.

[0159] In at least one embodiment, the amount of protrusion of the boss on the distal portion of the probe, or the position of the boss, can be adjusted mechanically, electrically, or pneumatically. In a first position, the boss may be flush with or recessed from the lower surface of the distal end portion of the probe, such that even when the probe contacts the eye, the boss does not contact the eye or exert pressure on it, which may be preferred when the probe is advanced along the outside of the eye towards the desired position. To allow the user better visualization of the probe's position, the boss can be adjusted from time to time so that it protrudes from the lower surface of the distal end portion of the probe and exerts pressure on the eye, thereby creating an additional indentation (in addition to the indentation created by the lower surface of the distal portion of the probe in contact with the eye / sclera), which the operator can see from outside the eye through an ophthalmoscope or other device. In at least one embodiment, the boss can be adjusted to protrude more or less and result in larger or smaller indentations, depending on the need for easy observation.

[0160] In any embodiment of the probe described herein, the distal curved end portion may be rigid. Alternatively, in at least one embodiment, the probe may have a flexible portion adjacent to the distal end portion that is adjustable to adjust the angle of the longitudinal axis of the distal end portion relative to the longitudinal axis of the body. In such embodiments, this angle may be adjustable between approximately 15 degrees and approximately 60 degrees.

[0161] In another alternative, any of the embodiments described herein can be modified such that the distal curved end portion is telescoping relative to the body of the probe. This can help achieve the proper posterior position on the eye during ophthalmic surgery. As an example, using probe 300b, this can be achieved by approximately... Figure 3A The telescopic arm extends from position T to increase the length L1 of the distal bent end portion. In at least one case, a locking mechanism may be engaged to prevent accidental extension or retraction during use.

[0162] Furthermore, any of the embodiments described herein can be modified to make the distal curved end portion sufficiently flexible, allowing the radius of curvature of the distal curved end portion to be varied to better conform to the surface of the eye (e.g., the sclera) during ocular surgery. As an example, using probe 300b, by bending the distal end portion of probe 300b, the radius of curvature of the lower surface of the distal probe end, indicated by reference numeral 304b, can be slightly altered.

[0163] Now for reference Figures 3C to 3D (Dimensions not to scale) Examples show different placements of the distal ends of different probes 310 and 320 on the scleral surface of the eye. Figure 3BIn this design, probe 310 has a boss 312 that, together with one or more sensing mechanisms described herein, allows for the accurate positioning and depth of needle 314, which extends approximately perpendicularly from the distal end portion of probe 310 into the sclera, and injects therapeutic fluid to form a bubble (e.g., a viscoelastic bubble in this example) in the SCS, which forms the choroidal cingulate band. However, the boss can also be optional when using a probe without affecting the accuracy of the procedure. Figure 3C In this embodiment, probe 320 also has an optional boss 322, but the probe used has an angle between the longitudinal axis of the probe body and the curved distal end and has a longer length, allowing it to reach further posteriorly along the posterior surface of the eye, enabling the injection of therapeutic fluid into the SCS or subretinal region depending on the ocular treatment being performed. In each of these examples, during the procedure, pressure on the scleral surface of the eye is used by a visualization technique described herein to properly position the distal curved portion of the probe and the needle to press into the scleral surface of the eye before the needle extends and begins to enter the eye.

[0164] like Figure 3C and Figure 3D As shown, the distal end of the probe is angled, and its radius of curvature conforms to the eye (e.g., the scleral surface). The probe can be placed directly on the conjunctiva as far posteriorly as possible based on the conjunctival fornix. For more posterior positions, a small conjunctival incision may be required. Once the probe is placed at the desired location on the scleral surface, the surgeon can gently press the device in, and this indentation, created by the distal portion of the probe (the boss or plate portion according to the embodiment), is internally visible. The needle exit point (e.g., exit location) can be identified by assessing the midpoint of the indentation (since the needle exit point will be in the middle of the distal portion of the probe). Therefore, the surgeon can place the internal target location at the midpoint of the indentation to properly center the choroidal vesicle. This procedure can be performed under local anesthesia, subconjunctival anesthesia, subtendon 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 vertically from the inner surface of the distal portion, allows the surgeon to navigate to various target areas on the conjunctival or scleral surface without obstruction by the orbit and surrounding tissues, enabling the needle to penetrate the conjunctiva and / or sclera at the correct angle. Although the instruction manual may describe probe contact with the scleral surface without conjunctival incision, the lower surface of the probe may contact the conjunctival surface (as a thin mucosa covering the outer layer of the sclera and the sclera). Furthermore, as previously described, the guide beam 324 can be used to assist in the proper positioning and insertion depth of the extended needle. For example, the guide beam can be used for illumination or to indicate when the tip of the needle 106 penetrates different layers of the eye based on determining changes in transmitted or reflected light.

[0165] In at least one embodiment, a first safety mechanism is included in any of the probes described herein by including a sensor for sensing how much force a user applies to the distal end of the probe in contact with the eye. Feedback on the magnitude of this force can then be provided to the user, informing them not to apply too much force, as this could cause the needle to penetrate too deeply into the eye and inject or remove fluid from the eye in the wrong location. Applying too much force, for example, could also cause other undesirable consequences such as bleeding or retinal tears. Any suitable force sensor of sufficient sensitivity can be used to measure the force and / or pressure at the portion of the probe in contact with the eye. When the measured force exceeds a force threshold, indicating that the needle may be beginning to penetrate too deeply into the eye, feedback can be provided to the user, such as audible feedback, verbal feedback, or another suitable form of feedback, to notify the user to stop applying force.

[0166] In at least one embodiment, a second safety mechanism is included in any of the probes described herein to prevent excessive force from being applied to the patient's eye from the distal end portion of the probe. Reference now. Figure 3E An example embodiment of a probe 330 having a pressure distribution flange 332 is shown. The pressure distribution flange 332 can be implemented using a disc-shaped medical hemisphere or membrane, serving as a protective device and positioned on the lower surface of the probe 330 that contacts the scleral surface of the eye. The surface of the flange 332 that contacts the scleral surface of the eye can be concave and have a radius of curvature that conforms to the shape of the eye into which the needle is inserted (e.g., the scleral surface). The flange 332 can have different sizes and / or different degrees of concavity to accommodate eyes of different sizes. The flange 332 can be a separate piece attached to the probe 330 (e.g., by snap-fit ​​connection), or the flange 332 can be integral with the probe 330 and be part of the probe 330. Preferably, the flange 332 is positioned such that the needle 334 extends from an approximately central position on the flange 332. In embodiments incorporating a guide beam, flange 332 may be made of a material transparent to the wavelength of light that can be used to guide the beam, such that the guide beam passes through flange 332 with minimal attenuation, or flange may have an aperture through which the guide beam passes during use. Flange 332 may be positioned adjacent to and above boss 336 such that during use, flange 332 lies between boss 336 and the scleral surface of the eye. However, in embodiments without a boss, flange 332 is positioned directly on the lower surface of the distal end portion of the probe.

[0167] In at least one embodiment, the flange 332 (also referred to as a guard) can change shape when the user applies too much force, which, without the flange 332, would cause the needle tip to extend to a greater depth than desired, preventing the therapeutic fluid from being injected into the correct location. Therefore, this feature of the flange 332 helps maintain a relatively constant level of force as the needle 334 subsequently extends when correctly positioned and the sclera is indented, which would otherwise allow the needle to penetrate too deeply. In at least one embodiment, the shape change of the flange 332 can serve as a visual cue to inform the user to apply a smaller amount of force. Alternatively, or otherwise, the flange 332 can be formed such that the force applied by the user will be distributed across the surface of the flange 332 to prevent the user from applying too much force, which would otherwise be concentrated at the boss 336 (if used) or along the surface of the probe surrounding the base of the needle 334, such that the sclera may be indented and the needle 334 may penetrate deeper than intended as the needle 334 extends. Furthermore, the flange 332 can be sized to allow for small indentations but prevent larger indentations from being subjected to excessive forces that could cause excessive penetration into the eye. The flange size is also preferably designed so as not to be too large and obstruct the user's field of vision. In at least one embodiment, the same flange can be used to press the sphere in and replace the function of the boss 336, thus eliminating the need for the boss 336.

[0168] In at least one embodiment, a third safety mechanism is included in any of the probes described herein to prevent excessive force from being applied, causing the needle tip to extend too deeply into the patient's eye. The third safety mechanism can be used alone or in combination with a first and / or second safety mechanism. The third safety mechanism includes a depth limiter, such as a post or annular disc within the distal portion of the probe, such that the needle cannot extend beyond the surface of the distal end portion of the probe that contacts the scleral surface by a certain depth limit, which may range, for example, from about 0.5 mm to about 1.5 mm and can vary based on the specific eye (e.g., 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).

[0169] In at least one embodiment, a fourth safety mechanism is included in any of the probes described herein to prevent excessive force from being applied to the patient's eye from the distal end of the probe. Reference now. Figure 3FThe illustration shows an example embodiment of a probe 340 including a portion of a variable connector 342. The variable connector 342 is disposed between a boss 336 and a flange 332. In some embodiments having a variable connector 342 and a flange 332, the boss 336 may be optional. Furthermore, in some embodiments having a variable connector, the flange 332 may be optional, and the variable connector may be located below the boss 336. The variable connector provides a variable mechanical connection to prevent the user from applying too much force, causing the needle to penetrate too deeply. Thus, in at least one embodiment, the device / probe includes a flange and / or a variable connector at the exit position to maintain position or pressure between the side surface and the surface of the eye. In at least one embodiment, the variable connector may include a spring or have a piston that moves within a cylinder to absorb some additional force. In at least one embodiment, the spring may be adjustable such that the connector is configured to be rigid during needle insertion, but becomes “soft” once the needle tip is at the desired depth, so that further changes in applied pressure do not cause a change in the needle tip position. In at least one embodiment, the variable connector 342 may be adapted to suppress pressure applied to the eye by the distal end portion of the probe when the pressure or force applied to the eye during use exceeds a threshold. For example, the variable connector may include a pressure relief valve that releases pressure when the pressure applied to the eye during use exceeds a threshold, or the variable connector may include a force damper that releases pressure when the force applied to the eye during use exceeds a threshold.

[0170] Now for reference Figure 3GThe diagram shows a front view of an example embodiment of a pressure distribution flange 350 having one or more sensors 352 (only one of the sensors is labeled and shown as a dot for simplicity). In at least one embodiment, the sensor(s) 352 may be a strain sensor used to detect changes in the curvature of the flange 350, which would indicate that the user has applied too much force during scleral indentation or needle extension and provide feedback (such as auditory or visual) to the user so that they can reduce the applied force. Alternatively, at least one of the sensors 352 may be a pressure or force sensor whose measurements can be compared to a force threshold to provide auditory or visual feedback to the user when too much force is applied during scleral indentation and / or needle extension. In another alternative, multiple pressure / force sensors are evenly distributed around the flange 350. If the sensors 352 provide approximately similar measurements, this could indicate that the flange is perpendicular to the eyeball during scleral indentation, causing the needle 334 to extend approximately perpendicularly into the sclera. If the measured pressure is uneven, it could indicate that the flange is tilted, meaning that if the needle 334 is extended / deployed, it may not insert perpendicularly into the sclera. This could be useful when performing manual insertion of a needle into the eye.

[0171] Now for reference Figure 3H This document illustrates an example embodiment of an eye device 360 ​​that can be used with ophthalmic treatment devices for accurate positioning and precise needle depth insertion in ophthalmic treatments. In this example embodiment, the eye device 360 ​​is completely housed within a body 102, such that the eye device 360 ​​also functions as a probe, making it a standalone device without the use of any external fluid connections (e.g., tubing) or electrical connections. In at least one embodiment, the hardware of the device 360 ​​may be housed in a first portion, and the fluid may be housed in a second portion that is releasably connectable to the first portion. This allows the second portion, which houses the fluid component, to be disposable for a single use with a single patient, or partially disposable for some reusable components that can be sterilized. The distal end portion generally has a curved portion with an arc angle, as illustrated in other embodiments of the probe described herein.

[0172] The standalone eye device 360 ​​can have various internal structures, and in this example, the eye device 360 ​​has some components similar to probe 201, and also includes several components of control unit 250. All these similar components operate as previously described. It should be noted that... Figure 3H The elements are not drawn to scale. In at least one alternative embodiment, as illustrated with respect to other embodiments described herein, a boss may be included at the distal curved end portion.

[0173] The eye device 360 ​​can perform both injection and drainage and includes a drainage conduit / tube 228' disposed on one side of the device 360 ​​while hardware is disposed on the other side. In an alternative embodiment, the device 360 ​​may include only a single conduit, such as conduit 104, which can be used for both injection and drainage as described in another embodiment herein. Port 210 may also be used to connect to a plunger if fluid needs to be injected into the eye (or to remove fluid from the eye when conduit 104 is used for both injection and drainage). Alternatively, in a dual-conduit implementation, the drainage conduit 228' is coupled to a drainage port 362 that can be fluidly coupled to a drainage device (e.g., a pump). Drain port 362 may be optional if the fluid portion of the device 360 ​​is discarded after use. The device 360 ​​also includes a fluid port 216 for coupling fluid to the injection conduit 104, where fluid will be injected into the eye during use. Alternatively, the device 360 ​​may be pre-loaded with fluid or may receive a fluid cartridge, as described in other embodiments herein.

[0174] In this example embodiment, for instance, device 360 ​​includes a microcontroller 362 for controlling the operation of various hardware components of device 360, and a power supply 364 for providing power to various components of device 360, such as microcontroller 364 and any motors. Microcontroller 364 also includes a memory device (not shown) for storing program instructions that, when executed by microcontroller 364, configure microcontroller 364 to perform various functions. Power supply 366 may be a rechargeable or non-rechargeable battery. If device 360 ​​is instead tethered to a power outlet or another device that can provide power, power supply 366 may include surge protection and voltage regulation circuitry.

[0175] Device 360 ​​also includes mode selection inputs such as buttons and sliders to switch between an injection mode that injects fluid into the eye and an expulsion mode that drains fluid from the eye. Device 360 ​​also includes fluid actuation control inputs 370 such as buttons and sliders to control an internal fluid actuator (not shown) to perform injection or expulsion, wherein the internal fluid actuator may be a motor that pushes / pulls an internal plunger (not shown) in various catheters. The fluid actuation input 370 can be pressed during fluid injection or expulsion depending on whether an injection or expulsion mode is selected, and then released to stop the injection or expulsion.

[0176] Device 360 ​​also includes a needle actuation control input 372 for controlling the extension and retraction of the needle 106, as illustrated previously with respect to other embodiments described herein. As described herein, input 372 can be used to gradually extend the needle into the eye.

[0177] The device 360 ​​may also include one or more sensors 107, such as any combination of pressure sensors, force sensors, and impedance sensors described above. For illustrative purposes, in Figure 3H The location of sensor 107 is shown in the figure, and it may be located at other locations in other embodiments.

[0178] Device 360 ​​also includes a light source 374, which can be used to generate white light that is transmitted along optical fiber 109 and emitted from the lower surface of the distal end portion, adjacent to a location where the needle 106 extends away from the lower surface of the distal end portion during use. Light source 374 can generate white light during visualization or generate a colored beam that is used as a guide beam, as illustrated in other embodiments described herein. Light source 374 can be located at the distal end of device 360 ​​and coupled to an injection catheter at a more distal end, using the injection catheter as a light transmission conduit. In at least one embodiment, a mirror can be used to reflect laser / light along the length of device 360.

[0179] In at least one embodiment, device 360 ​​may also include a radio (not shown) for short-range or long-range wireless communication, such that any sensor data collected during operation may be provided to another device, such as a display or control unit 250, for providing feedback and replay to the user during operation, such as various parameter values ​​described for control unit 250.

[0180] 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 visual feedback to a user on specific parameter values ​​during device operation. In at least one embodiment, device 360 ​​may include a speaker and / or a vibrator for providing feedback to the user, as illustrated in the earlier embodiments described herein. In at least one embodiment, the vibrator and / or speaker may be optional.

[0181] In an alternative embodiment, device 360 ​​may be configured to not use any electronic hardware, in which case the device is implemented using mechanical and / or pneumatic components for control and actuation.

[0182] Now for reference Figure 4A The diagram illustrates a flowchart of an example embodiment of a method 400 for treating retinal tears or RRD according to the teachings herein. At step 402 of method 400, the user sets up the ocular treatment device using probe 1010 or another suitable probe described herein. This setup may include connections to various conduits and wires, as well as the loading of treatment fluid.

[0183] Method 400 then proceeds to step 404, where the user examines a patient with RRD or retinal tears in the operating room using an indirect ophthalmoscopy or wide-field observation. For example, a binocular indirect ophthalmoscopy can be used to visualize the posterior segment of the eye. An optical lens such as a 28D lens, or another lens such as a 20D lens, can be used at this time. The user can wear a light source on their head to allow them to observe the inside of the eye binocularly, thus providing a 3D view. The user can use this equipment when examining the posterior segment of the patient's eye and when treating retinal tears or RRD devices.

[0184] Method 400 then proceeds to step 406, where the user uses probe 101 or 201, wherein the needle is retracted such that it does not extend beyond the distal end of probe 101 or 201, allowing the scleral end of probe 101 or 201, or another suitable probe described herein, to be used to press on the sclera and locate one or more tears in the retina. In method 400, one of the positioning / visualization techniques described herein may be used to ensure the needle is properly positioned on the sphere and inserted approximately perpendicularly into the sclera.

[0185] Once the user detects one or more ruptures in the retina, method 400 proceeds to step 408, where the user can use needle actuator 108 to extend needle 106 to a depth of approximately 3 mm to approximately 1.5 mm to reach the rupture in the SCS. One of the techniques described herein for extending the needle can be used, which may include any combination of one or more sensors, one or more visualization techniques, and one or more safety mechanisms described herein that include motorized or graded manual slow advance of the needle upon application of injection pressure.

[0186] Method 400 then proceeds to an optional step 410. In step 410, depending on the implementation of the guiding tool for probe 101 or 201 or other suitable probes described herein, any combination of light, OCT measurement, US imaging, and resistance feedback can be used to confirm that the tip of needle 106 is located in the SCS.

[0187] Method 400 then proceeds to step 412, in which, as previously described, the user injects a therapeutic fluid, such as a viscoelastic agent or other substance, into the patient's SCS. The user continues to inject the therapeutic fluid until a sufficient amount has been injected. For example, once a choroidal blister / ring has formed around one or more retinal tears and extends beyond the edge of the retinal tear, such as, but not limited to, extending approximately 4 mm to approximately 5 mm beyond the edge of the one or more retinal tears in all directions, a sufficient amount of choroidal blister / ring can be injected. The volume of the therapeutic fluid used can vary based on the number, size, and location of the retinal tears. For example, in most cases, approximately 0.7 cc to approximately 1 cc of therapeutic fluid can be injected. The choroidal ring formed by the choroidal indentation under the retinal tear causes a change in intraocular hydrodynamics (i.e., intraocular fluid flow) and a reduction in traction on the retinal tear, resulting in less or no fluid entering the subretinal space through the retinal tear, and then the retina reattaches as the retinal pigment epithelium reabsorbs any fluid in the subretinal space. This choroidal ring can be achieved in any quadrant including the lower quadrant using the techniques and devices described herein.

[0188] In an alternative embodiment, a second injection can be performed after the first injection. Because the first injection has already created a separation between the choroid and sclera, the second injection may be easier to perform than the first. Therefore, for the second injection, the needle can be extended to a greater length, such as approximately 1 mm to approximately 2 mm. The second injection will be easier because the bubble already present from the first injection will make it less likely that the needle 106 will penetrate into the subretinal or vitreous space, due to the larger gap in the SCS and therefore the needle can now be longer, making it easier to maneuver and place in the correct space where the existing viscoelastic material exists. In other words, the second injection of the treatment fluid can be performed at the location of the first bubble of the treatment fluid. This is another advantage of using a device with needle extension capabilities as taught herein, since the amount of needle extension can be tailored to the location where the second injection is needed. In some cases, such as when too much viscoelastic material has been injected, potentially causing excessive intraocular pressure, or if further treatment such as vitrectomy is required after performing the ST approach, 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 an extension beyond the distal end portion of the lower surface (thus effectively changing the length of the needle used for insertion into the eye, with or without additional guidance, to enter the suprachoroidal space and then aspirate the viscoelastic material). In some cases, because the patient has multiple retinal tears or ruptures, it may be desirable to treat multiple sites in the same eye. This can be achieved by generating small local vesicles around each tear or rupture, or by performing consecutive treatments at intervals of one day, so as not to raise the intraocular pressure too high with a single injection of too much treatment fluid.

[0189] Now for reference Figure 4BThe diagram illustrates a flowchart of another example embodiment of method 420 for treating retinal tears or RRD according to the teachings herein. Method 420 is somewhat similar to method 400 because it includes steps 402 through 412 for setting up the device and performing the injection. However, method 420 includes an additional step for performing drainage on the patient's eye prior to the injection. Because method 420 involves performing drainage, the probe 201 described herein or another suitable probe can be used. For example, step 422 may be performed after step 406, where the user uses probe 201 with a retractable needle to press on the sclera and locate one or more tears in the retina. Step 422 involves the user checking whether drainage must be performed. This may involve the user examining the patient's eye with an indirect ophthalmoscopy and / or a wide-angle viewing system with a condenser lens that allows for wide peripheral observation of the posterior segment. If the retinal detachment is severe, this may increase the likelihood that the user can consider increasing drainage during surgery. When drainage is used, this allows the retina to remain better on the choroidal cingulates formed by the viscoelastic material, which increases the likelihood that the choroidal cingulates will effectively close the retinal tear and reduces the flow of fluid through the retinal tear and into the subretinal space. If the user determines that drainage is not necessary, for example for a shallower retinal detachment where the choroidal cingulates provide sufficient indentation to close the retinal tear without drainage, method 420 involves performing steps 408 to 412 as described in method 400. This may also include a second injection later as previously described. Alternatively, if the user determines at step 422 that drainage is necessary, method 420 moves to step 444, where the user extends the tip of the needle using needle actuator 108 to a length / depth of approximately 1.5 mm to approximately 3 mm. The needle tip extends 1.5 mm to approximately 3 mm such that the needle 106 is safely present in the subretinal space, but far enough from the retina that it does not impinge on the retina or cause a retinal tear. Method 420 then proceeds to step 426, where active or passive drainage is performed as previously described. The user can decide to stop drainage by visually observing that the retinal detachment in the patient's eye is receding, by observing the fluid moving away from the subretinal space, causing the retina to flatten / adhere. The user will stop drainage and remove or slightly retract the needle before it contacts the retina. After aspiration, method 420 proceeds to step 408, where the user may need to reposition the needle at the location of the retinal tear before advancing the needle into the SCS. In other embodiments of this method, drainage may be performed after (rather than before) the injection of the viscoelastic material, or drainage may be performed alone without the injection of the viscoelastic material.

[0190] Now for reference Figures 4C to 4NThe image shows images of different stages in repairing retinal tears or RRDs according to the teachings of this article. Figure 4C In the image, the patient's eye 450 displays a split-source retinal detachment (RRD) 452 with an outer retinal ripple 454. As can be seen, a probe with a boss was used in this example. However, as previously explained, 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. Figure 4D In accordance with the teachings of this paper, a probe 460 for delivering a viscoelastic material onto the choroid is advanced and precisely positioned such that the needle of the probe 450 is at the desired ocular surface location at the site of an unpleasant retinal tear. Figure 4E In this configuration, the guide beam 463 can be directed towards the surface of the eye to aid in positioning. Figure 4F In the process, once the user determines that the needle is in the correct position on the surface of the eye, needle 462 begins to extend and penetrate the surface of the eye. Figure 4G In this process, needle 462 is inserted into 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 will cause the viscoelastic agent to flow before needle 462 enters the SCS. Figure 4H In this process, once the needle enters the space above the choroid, the viscoelastic material 464 will flow from the probe 460, through the needle guide, and into the SCS to create a choroidal indentation / fastening 466, and the needle 462 can retract and remove the probe 460. Figure 4I In this process, the choroidal indentation / ringing 466 reduces / eliminates the inflow of liquefied vitreous fluid from the vitreous cavity into the subretinal space. The retinal pigment epithelium (RPE) 468 regains control of the subretinal space and reabsorbs the subretinal fluid (as indicated by the arrow). Figure 4J In this state, RPE 468 had reabsorbed most of the subretinal fluid and the retina was nearly completely adhered. Figure 4K In this case, the retina is completely adhered, and laser retinal fixation can be applied 470 to create a permanent choroidal-retinal adhesion between the retina and the RPE 468 surrounding the retinal tear. In some cases, cryo-fixation of the retinal tear can be applied before injecting a viscoelastic material onto the choroid, thus eliminating the need for subsequent laser retinal fixation. Figure 4L In this procedure, laser retinal fixation is performed around the retinal tear. The laser burn results in scarring that leads to choroidal-retinal adhesions.472 Figure 4M In the middle, choroidal-retinal adhesions 474 have already formed around the tear. Viscoelastic material on the choroid 464 begins to reabsorb, resulting in reduced choroidal indentations / cings 467. Figure 4NIn this case, the retina is completely adhered. There is good choroid-retinal adhesion, and the viscoelastic material on the choroid has been completely reabsorbed.

[0191] It should be noted that while the illustrative use of the devices described herein relates to providing a therapeutic fluid for treating retinal tears or RRD, it should be understood that various embodiments of the devices described herein can be used for precise positioning and accurate needle penetration depth in a variety of other ocular surgeries, which is particularly advantageous when providing a treatment location from the posterior region of the eye. Furthermore, in these different ocular surgeries, the therapeutic fluid can be, but is not limited to, a drug, gene therapy, hydrogel, or different types of viscoelastic fluid. For example, the devices described herein can be used for more precise posterior-targeted drug delivery without relying on drug diffusion, allowing the drug to be precisely injected into or adjacent to the diseased ocular tissue. Additionally, hydrogels can be precisely injected where needed to continuously deliver novel or rare drugs. For example, hydrogels or other extended-release platforms can be used in conjunction with one of the device embodiments described herein to deliver any agent to the posterior region of the eye. This includes medications for treating conditions such as, but not limited to, 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, proximal and distal telangiectasia, Coats' disease, retinopathy of prematurity, familial exudative vitreoretinopathy, and other conditions of the retina and choroid. One of the device embodiments described herein can also be used to directly treat the subretinal space (SCS) or subretinal space, wherein these treatments include, but are not limited to, antibody therapy, antibody fragments, aptamers, orphan drug solutions, gene therapy, etc.

[0192] Compared to conventional drug / agent delivery systems used for the subretinal and suprachoroidal spaces, the various devices and methods described in this teaching are also advantageous. Conventional drug / agent delivery systems rely on an anterior scleral incision through which a cannula / drainage tube can be advanced through the suprachoroidal space. Typically, the agent is then injected into the suprachoroidal space, or alternatively, a needle can be inserted into the choroid and retinal pigment epithelium to inject the agent into the subretinal space. The problem with this approach is that it requires more invasive operating room procedures and scleral incisions, as well as opening the cannula / drainage tube within the SCS. These procedures carry inherent risks, which can be avoided and procedures simplified by using one of the devices described herein that allows direct scleral penetration (via the conjunctiva or a smaller conjunctival incision) at the precise desired location to deliver the agent to the SCS, subretinal space, or another part of the eye.

[0193] Based on the teachings herein, by using appropriate bending / angle and length to bring the probe to any desired scleral location, and by extending the needle from the lateral surface of the distal end portion of the probe adjacent to the scleral surface, such that the needle is inserted directly through the sclera (or via the conjunctiva), accurate positioning of the desired location on the patient's eyeball and needle depth accuracy at an appropriate angle (preferably approximately perpendicular, e.g., 90 degrees) to the sclera allow penetration into the SCS, the choroid / RPE into the subretinal space, or other penetrations in other areas of the eye. Accuracy can be further improved by using guiding tools and / or one or more sensors as described herein, allowing the needle to precisely reach the desired target layer (superchoroidal or subretinal) without over- or under-penetration. The accuracy / ease of use of the device described herein can be further improved by using one or more actuation mechanisms as described herein to precisely position the needle and penetration depth and / or by providing safety mechanisms as described herein to prevent over- and under-penetration and / or the use of excessive force during needle insertion.

[0194] At least one of the embodiments of the devices and methods described herein can be used for one or more purposes, such as, but not limited to, a) injecting a viscoelastic agent into an SCS at a given location in the diseased retinal tear area to treat RRD, b) draining subretinal fluid in the RRD area, c) delivering a drug to an SCS at a location such as the posterior macula, d) delivering a drug to a subretinal space at a location such as the posterior macula, and e) draining fluids such as suprachoroidal fluid / hemorrhage or subretinal fluid / hemorrhage.

[0195] Referring now to Figure 40, a flowchart of an example embodiment of a method 480 for performing precise positioning and accurate needle depth insertion on the surface of the eye for ocular surgery is shown. Method 480 can be performed using one of the devices described in accordance with the teachings herein.

[0196] At step 482, setup is performed to prepare the device for use. This may involve performing calibration and, in addition, loading reagents into the device (if the device is not pre-filled with reagents). Any required tubing and wiring can be connected (if needed), and the device can be filled if necessary. Standalone devices do not require tubing or wiring.

[0197] At step 484, the user moves the device to place the distal portion of the device at the desired location on the sclera or conjunctiva by forming an indentation as previously described. This can be done directly on the conjunctiva at or ahead of the equator. For locations behind the equator, a small conjunctival incision may be required. It should be noted that small conjunctival incisions are generally not noticeable, while scleral incisions are more invasive. This desired location can be confirmed by indirect ophthalmoscopy (in other words, the user can examine the eye from within to see the indentation formed by the distal end to confirm accurate positioning) or by wide-field observation in an operating room. At least one of the sensors described herein can also be used to confirm the desired location.

[0198] At step 486, since the user has predetermined whether the injection / aspiration is a) on the choroid or b) under the retina, the user can confirm the penetration depth before inserting the needle into the eye, for example by using imaging methods such as OCT, ultrasound or other optical methods, guiding tools and / or sensing mechanisms described herein to measure the thickness of the eye layers and / or structures.

[0199] At step 488, the needle extends into the eye, which can be done manually or using the automated techniques described herein. The needle extends from a lateral surface of the distal end portion of the device that can be accessed by the tip of the distal end portion, but emanates (e.g., extends) from a lateral surface of the probe adjacent to the surface of the eye, wherein the lateral surface passes through the sclera at an appropriate angle / orientation and toward the suprachoroidal or subretinal space adjacent to the scleral surface.

[0200] At step 490, for SCS injection, injection pressure is applied as the needle advances through the sclera, causing injection to occur as soon as the needle enters the SCS to prevent excessive needle depth penetration. For subretinal injection, the needle is advanced and injection pressure is applied once the needle is in the choroid and near the RPE, causing a bubble of subretinal fluid to form as soon as the needle penetrates the RPE. For aspiration from the SCS, aspiration begins while the needle is in the sclera, causing fluid to flow as soon as the needle enters the SCS. For subretinal aspiration, aspiration begins once the needle is visualized in the subretinal space. Needle positioning (e.g., penetration depth) can be confirmed using one of the guiding tools and / or sensing mechanisms described herein, such as, but not limited to, fiber optic / laser, laser reflection, insertion resistance, etc., to confirm precise needle depth penetration.

[0201] In step 492, when injection / aspiration is performed in the SCS or subretinal space, the user (e.g., a surgeon) can examine the interior of the eye with an indirect ophthalmoscopy or wide-field intraoperative observation to assess the desired clinical endpoint.

[0202] At 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 pulsating or blocked, a slow anterior chamber puncture can be performed to reduce pressure. This should be done in small amounts, as excessively rapid reduction of pressure may cause bleeding.

[0203] At step 496, it is determined whether a repeat procedure or re-injection / re-aspiration is required, as this may occur depending on the circumstances in some cases.

[0204] Example 1: In-office choroidal microscopy for retinal detachment repair The results of minimally invasive, in-clinic treatment applications of ST methods for treating RRD will now be discussed.

[0205] method A patient in his 50s with an intraocular lens and a best-corrected visual acuity of 20 / 50 OD in Snellen was admitted to Unity Health Toronto. Figures 5A to 5C This image shows a longitudinal ultrawide field photograph of a patient with an intraocular lens that presents with RRD in the right eye. Figure 5A Baseline images showing a temporal inferior RRD involving the fovea from 6 o'clock to 10 o'clock without a clearly identifiable cause of retinal tear are presented. According to the rules of Lincoff and Gieser12, the tear is considered temporal or superior temporal. After discussing the treatment plan and obtaining written informed consent, 1% sodium hyaluronate (restrictive clause, Alcon) was injected into the patient's superior temporal quadrant under subconjunctival anesthesia using some early prototypes with some similar uses to those described in the device embodiments herein. The prototypes included a 30-gauge needle with a custom guard that exposed 1 mm of the needle. The custom guard was fabricated using an intravenous tubing (Med-RX, Hospital Specialty Inc., Canada). A syringe loaded with viscoelastic material was attached to the needle. The injection site at the suspected tear location was internally verified using an indirect ophthalmoscopy (confirming the needle was not too deep), and 0.4 mL of viscoelastic material was slowly injected transconjunctivally under direct visualization, simultaneously forming a dome-shaped choroidal bulge. During the injection, the patient experienced an initial pressure sensation (as did the injection assistant) as the choroidal vesicle opened; this pressure decreased as the vesicle spread and remained tolerable for the remainder of the procedure. Because central retinal artery perfusion was confirmed, anterior ventricle puncture was not required. Although video of the intraocular choroidal convexity could not be obtained during in-clinic surgery, in two other patients, similar techniques for inferior retinal support and temporal retinal tears were used intraoperatively as a combination of PPV and ST approaches. Specifically, Figure 6The final appearance of the choroidal convexity formed after performing the ST method is shown. Reporting guidelines for the case series by Kempen are followed.

[0206] result The day after surgery, the patient was able to resume normal activities without restriction. On the first day after the ST method was performed, the macula was completely adhered. For example, Figure 5B The first day following the ST procedure is shown, demonstrating how the retinal detachment was largely resolved using initial spots of laser retinal fixation applied to the temporal periphery. Small localized temporal hemorrhages were observed near the injection site.

[0207] Longitudinal sweep optical coherence tomography (SS-OCT) showed rapid retinal reattachment and intact recovery of the foveal outer membrane and elliptic region (see [link]). Figures 8A to 8D The patient underwent a reattachment phase without any anatomical abnormalities. Figure 8A The baseline scan is shown. Figure 8B The scan shown is from the first postoperative day, in which there is significant improvement in outer retinal ripples and macular cystoid edema (stage 2). Figure 8C The scan taken on the second day after surgery shows the contact between the retina and the retinal pigment epithelium (stage 3). Figure 8D The scan shown on postoperative day 3 demonstrates the regression of the bacillus layer (stage 4). On postoperative day 5 (not shown in the attached figure), the patient showed improved integrity of the outer retinal band (stage 5). The patient achieved complete retinal reattachment, and the integrity of the outer membrane and elliptic region rapidly recovered. Figure 9 As shown in the image, autofluorescence imaging of the fundus was performed on postoperative day 5, and there was no sign of retinal displacement in the posterior pole, indicating that the patient had achieved highly intact retinal reattachment (HIRA).

[0208] SS-OCT scans of the choroidal convex position reveal the low-reflectivity gap between the sclera and choroid, indicating the location of viscoelastic material in the suprachoroidal space (SCS). For example, Figures 10A to 10C This image shows longitudinally swept optical coherence tomography (OCT) scans of the temporal macula and mid-temporal periphery, demonstrating the location of the ST method on the left side of the image. Arrows point to viscoelastic material in the low-reflectivity space between the sclera and choroid, indicating the location of viscoelastic material in the choroidal space during the first week post-surgery. Figure 10A The scan taken on the first day after surgery is shown. Figure 10B The scan taken on the third day after surgery is shown, and Figure 10C The scan taken on postoperative day 5 is shown. Throughout the time interval following the ST segment, the height of this low-reflectivity gap was observed to gradually decrease (arrow).

[0209] On the first postoperative day, laser retinal fixation was applied to the area suspected of tearing (see [link]). Figure 5B and Figure 5C ).For example, Figure 5C The image shows a complete laser-assisted retinal fixation barrier in the suspected retinal tear area on the third day after the ST procedure. Mild residual subretinal fluid was observed in the lower periphery and improved slowly, without open tears. For example, in Figures 11A to 11B The image shows an ultra-wide field fundus scanning source OCT scan demonstrating complete reattachment of the macular region. Specifically, Figure 11A The low-reflection space between the choroid and sclera (indicated by arrows) is shown to illustrate the viscoelastic material on the choroid. Figure 11B The image shows mild residual subretinal fluid, with no lateral retinal folds in the lowest periphery (star shape), indicating that the residual subretinal fluid has slowly dissolved over time.

[0210] The size of the choroidal convexity decreases during the first week (see...) Figure 7A and 7B And it completely disappeared within 2 weeks. Figures 7A to 7B It was obtained by performing longitudinal vertical sweep frequency source optical coherence tomography at the viscous fixed injection site. Figures 7A to 7B It showed the progress from the first day after surgery ( Figure 7A ) to the 5th day after surgery ( Figure 7B Gradual reabsorption of the viscoelastic material on the choroid (the low-reflectivity space between the choroid and sclera, indicated by the arrow). The degree of viscoelasticity on the choroid was assessed by performing a 12×12-mm cube on the temporal periphery. Best corrected visual acuity was 20 / 25 on postoperative day 5, which remained stable during the first month of follow-up.

[0211] discuss Despite the risks of choroidal hemorrhage, infection, and unintentional intraocular injection or retinal perforation, the ST approach can be performed in an office and appears to be relatively less invasive compared to previous viscoelastic injection routes into the SCS. The procedure in this study was performed using an early prototype with a custom-designed 30-gauge needle guard that used an intravenous infusion tubing that exposed 1 mm of the needle and allowed the viscoelastic material to be injected into the SCS from a syringe loaded with the viscoelastic material and fluidly coupled to the guarded needle. During injection, if the needle was within the sclera, there was significant resistance to overcome as the needle was advanced slightly into the SCS under additional pressure.

[0212] From the study, the inventors believe that performing the ST method in the clinic may be a reasonable approach for patient selection. This method may be well-suited for acute RRD without proliferative vitreoretinopathy and may be preferred for cooperative patients who are at rest for at least one hour. It may be particularly advantageous for lower tears, in which pneumatic retinal fixation may be less likely to succeed; however, because the absence of tamponade and positioning requirements is a significant advantage of the ST method, this procedure can also be performed for upper tears according to the teachings herein. Additionally, the ST method can be used in combination with PPV or pneumatic retinal fixation for further support in retinal tears. 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 retains its useful effect for at least 7 to 10 days.

[0213] The benefits of performing this technique according to the teachings of this article include the complete natural reabsorption of the viscoelastic agent, reduced invasiveness from injection via a small-gauge needle, and the fact that these substances are immune-inert. Long-acting viscoelastic agents may be even better. Additionally, some of the complications associated with conventional SB surgery can be avoided.

[0214] In one aspect, in accordance with the teachings herein, at least one embodiment of a device for a patient with an eye suffering from rhegmatogenous retinal detachment (RRD) or retinal tear is provided, wherein the device comprises: a probe comprising: a body having a longitudinal axis and a distal end angled / curved or straight relative to the longitudinal axis; an injection catheter for receiving therapeutic fluid injected into the suprachoroidal space (SCS) of the eye for treating RRD or retinal tear; a needle disposed at the distal end of the probe having a needle conduit fluidly connected to the injection catheter for injecting the therapeutic fluid into the SCS of the eye; and an actuator controllable by a user for moving the therapeutic fluid from the injection catheter through the needle conduit into the SCS of the eye.

[0215] On the other hand, in accordance with the teachings herein, at least one embodiment of a device for injecting or draining fluid into or from a patient's eye is provided, wherein the device comprises: a probe including: a body having a longitudinal axis and a distal end angled or straight relative to the longitudinal axis of the body; one or more probe conduits for moving fluid through the probe; a distal curved end portion having a lower surface and a portion of the lower surface being positioned against a surface adjacent to the eye during use; and an extendable needle disposed at the distal end portion of the probe, the needle having a needle conduit fluidly connected to one or more probe conduits for injecting or draining fluid into or from the eye, and the needle extending approximately perpendicularly away from the axis of the distal end portion of the probe for penetration into the sclera.

[0216] In at least one embodiment, the device includes a fluid actuator that can be controlled by a user to cause fluid to move through a needle catheter between one or more probe catheters and the eye.

[0217] In at least one embodiment, the distal end portion of the probe has a predetermined radius of curvature, arc length, and arc angle for contacting a desired location on the surface of the eye during use, wherein the radius of curvature approximately matches the radius of curvature of the eye or sclera into which the needle is inserted.

[0218] In at least one embodiment, the distal end portion has a boss on its lower surface, making the user aware of where the needle will extend from the probe.

[0219] In at least one embodiment, the needle extends beyond the boss during use.

[0220] In at least one embodiment, the distal end portion of the probe is rigid.

[0221] In at least one embodiment, the distal end portion is flexible to adjust the radius of curvature of the lower surface of the distal end portion.

[0222] In at least one embodiment, the arc angle of the distal end portion is between approximately 15 degrees and approximately 60 degrees.

[0223] In at least one embodiment, the eye suffers from rhegmatogenous retinal detachment (RRD) or retinal tear, and the device is adapted to inject fluid into the suprachoroidal space (SCS) of the eye via an injection catheter and a needle catheter for the treatment of RRD or retinal tear.

[0224] In at least one embodiment, one or more probe catheters include an injection catheter for injecting fluid into the eye and an outlet catheter for draining fluid from the eye, and the needle has a needle position adjustable between an outlet position for fluidly connecting the outlet catheter to the needle catheter to drain fluid from the subretinal space or other location in the eye and an injection position for fluidly connecting the injection catheter to the needle catheter to inject the therapeutic fluid into the SCS or other location in the eye including the subretinal space, choroid, or vitreous space.

[0225] In at least one embodiment, the device includes a fluid actuator that can be controlled by a user to cause fluid to pass through the needle catheter from the injection catheter into the eye and / or from the eye into the discharge catheter.

[0226] In at least one embodiment, the probe includes a needle actuator that is user-adjustable for adjusting the needle position between a discharge position and an injection position.

[0227] In at least one embodiment, the probe includes a needle position indicator to indicate the needle position to the user.

[0228] In at least one embodiment, during discharge, the tip of the needle is adapted to extend into the eye from about 1.5 mm to about 3 mm to reach a subretinal position.

[0229] In at least one embodiment, at the injection site, the needle is adapted to extend into the eye by about 0.3 mm to about 1.5 mm for a first injection into the SCS, or the needle is adapted to extend into the eye by about 1 mm to about 2 mm for a second injection into the SCS.

[0230] 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 a user.

[0231] In at least one embodiment, the needle includes a circumferential orifice that is in fluid communication with an discharge conduit when the needle position is in the discharge position and with an injection conduit when the needle position is in the injection position.

[0232] In at least one embodiment, the discharge conduit includes a discharge cylinder having a distal end that is in fluid communication with a circumferential orifice 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 in fluid communication with a circumferential orifice of the needle conduit when the needle position is the injection position.

[0233] In at least one embodiment, the probe has a shape factor that allows the probe to be held in the hand, and the distal end of the probe is shaped to allow the user to press it into the sclera of the eye during use, the distal end of the probe being shaped as a scleral presser.

[0234] In at least one embodiment, the device has at least one sensor to allow the user to determine the location of a retinal tear or detachment or to locate the site of drug delivery in the eye during use.

[0235] In at least one embodiment, the probe includes at least one sensor, which is any combination of an impedance sensor, a mechanical resistance sensor, a pressure sensor, and a flow sensor, to measure impedance, insertion resistance, and / or injection resistance, wherein the impedance, insertion resistance, or injection resistance is approximately located at the tip of the needle to determine when the tip of the needle is in the sclera or SCS of the eye.

[0236] In at least one embodiment, the device further includes a guiding light source adapted to generate a guiding beam having one or more predetermined wavelengths to indicate when the tip of the needle penetrates different layers of the eye by means of variations in light intensity.

[0237] In at least one embodiment, the device further includes a light guiding sensor for sensing the reflection of a guiding beam to generate position data based on the location of the reflected beam having different light intensities when the tip is positioned in the sclera or SCS of the eye.

[0238] In at least one embodiment, the device further includes a guide tool optically coupled to the distal end of the probe to help the user position the distal end of the needle at the rupture location, wherein the guide tool includes a light source for illuminating the distal end of the needle.

[0239] In at least one embodiment, the device further includes a guide tool optically coupled to the distal end of the probe to help the user position the distal end of the needle at the rupture location, wherein the guide tool is 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 laser sensing device, or a light polarization sensing device.

[0240] In at least one embodiment, the device further includes a guiding tool that generates acoustic waves emanating from the distal end of the probe to help the user position the distal end of the needle at the rupture location, wherein the guiding tool is an ultrasound imaging device or an acoustic reflection measurement device.

[0241] 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, the processor being configured to perform one or more functions when executing the software instructions, the one or more functions including: receiving measurement data; and displaying at least a portion of the measurement data on the display.

[0242] In at least one embodiment, the measurement data includes any combination of insertion resistance, injection resistance, and / or resistance resistance to determine the depth of needle penetration, thereby indicating the position of the needle tip in the eye.

[0243] In at least one embodiment, the device includes a pump controllable by a processor, an injection port for receiving an injection tube, and an internal injection catheter fluidly connected to the injection catheter of the probe, the internal injection catheter fluidly connected to the injection port and the pump, and the pump being connected to a fluid source, wherein during injection, the processor is configured to send a pump control signal to the pump to generate an injection pressure, thereby moving fluid from the fluid source to the eye.

[0244] In at least one embodiment, the injection fluid may also be pre-loaded in the device, or the device may be filled with injection fluid immediately before use.

[0245] In at least one embodiment, the amount of injection pressure is set to a predetermined injection pressure level that can be adjusted between approximately 20 mmHg and approximately 70 mmHg.

[0246] In at least one embodiment, the device includes a pump controllable by a processor, 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 wherein 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.

[0247] In at least one embodiment, the discharged fluid can be collected in a discharge pipe within the device.

[0248] In at least one embodiment, the amount of suction pressure is set to a predetermined suction pressure level that is adjustable from 0 mmHg to approximately 700 mmHg.

[0249] In at least one embodiment, the actuator is coupled to the control unit such that during operation, when actuated by the user, the fluid actuator sends an actuator control signal to the processor to control injection or discharge at the probe.

[0250] In at least one embodiment, the probe includes an optical conduit disposed along the injection catheter, and the control unit includes an optical port for receiving an optical fiber optically coupled to the optical conduit, and the control unit includes an internal optical conduit optically coupled to the optical port and a light source.

[0251] In at least one embodiment, the device may also house its own internal light source to eliminate the need for an external light source.

[0252] In at least one embodiment, the probe includes an optical conduit disposed along an injection catheter, and the control unit includes an OCT device, an optical coherence elastography (OCE) device, an endoscope 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, the optical coherence elastography (OCE) device, the endoscope imaging device, the light intensity sensing device, the light scattering sensing device, the light wavelength sensing device, or the light polarization sensing device.

[0253] In at least one embodiment, the probe includes an ultrasonic transducer disposed at the distal end of the probe, and the control unit includes an ultrasonic imaging or acoustic reflection measurement device coupled to the ultrasonic transducer for receiving ultrasonic signals or acoustic reflection measurements, processing the received ultrasonic signals to generate an ultrasonic image or processing the received acoustic reflection measurements, and displaying the ultrasonic image or the processed acoustic reflection measurements on a display.

[0254] In at least one embodiment, the processor is configured to display on a display any combination of operating parameters including measured resistance, injection pressure, aspiration pressure, and position data.

[0255] In at least one embodiment, the control unit includes a speaker or vibrator communicatively coupled to the processor, and the processor is configured to generate an audio signal or vibration and output the audio signal via the speaker or the vibration via the vibrator, wherein the audio signal includes speech, tone, or buzzing, and the audio signal or vibration corresponds to device operating parameters and / or measurement data, the measurement data including any combination of injection pressure, aspiration pressure, or other data.

[0256] In at least one embodiment, a vibrator may be included to provide vibrational feedback in the probe, thereby providing tactile feedback that is preferably gentle (e.g., with small amplitude).

[0257] In at least one embodiment, the probe further includes a flange at the distal end of the probe to maintain the position of the distal end of the probe and the tip of the needle relative to the surface of the eye.

[0258] In at least one embodiment, the flange further includes one or more pressure sensors that communicate with a control unit to measure pressure at one or more points on the flange, and the control unit is configured to provide a visual or auditory output indicating the measured pressure.

[0259] In at least one embodiment, the device further includes a variable coupling at the distal end portion of the probe, the variable coupling being adapted to buffer pressure applied to the eye by the distal end portion of the probe when pressure or force applied to the eye during use exceeds a threshold.

[0260] In at least one embodiment, the variable connector includes a pressure relief valve that releases pressure when the pressure applied to the eye during use exceeds a threshold, or the variable connector includes a force damper that releases pressure when the force applied to the eye during use exceeds a threshold.

[0261] In at least one embodiment, the probe is telescopic to extend the distal end portion.

[0262] On the other hand, in accordance with the teachings herein, at least one embodiment of a method for treating a patient with an eye suffering from rhegmatogenous retinal detachment (RRD) or retinal tear is provided, wherein the method includes: setting an ocular treatment device having a probe and a needle having an adjustable needle position; examining the patient's eye; using a needle retraction device to press and locate 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 guiding tool; and injecting a treatment fluid such that the treatment fluid enters the SCS of the patient's eye.

[0263] In at least one embodiment, the injection begins just before the tip of the needle enters the SCS.

[0264] In at least one embodiment, injection begins as the needle is advanced 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.

[0265] In at least one embodiment, the needle tip extends from about 0.3 mm to about 1.5 mm at the injection site.

[0266] In at least one embodiment, the method further includes performing the method again to provide the patient with an additional injection of the therapeutic fluid on the same day or a different future day.

[0267] In at least one embodiment, for the second injection, the tip of the needle extends from about 1 mm to about 2 mm.

[0268] In at least one embodiment, the treatment fluid is a viscoelastic fluid, an inert gas or air, a hydrogel, a prolonged release implant, or a drug solution.

[0269] In at least one embodiment, the drug solution contains or does not contain a preservative, and / or the drug solution is used for antibody therapy, gene therapy, steroid therapy or other drug therapy.

[0270] In at least one embodiment, the viscoelastic agent includes hyaluronic acid, cross-linked hyaluronic acid, 1% to 2.3% sodium hyaluronate, and a soluble or insoluble hydrogel spacer.

[0271] In at least one embodiment, when determining that fluid is to be drained from the subretinal space of the patient's eye, the method further includes: advancing the needle position to the drain position; and performing active or passive fluid draining from the subretinal space before or after the injection of SCS.

[0272] In at least one embodiment, at the discharge position, the tip of the needle extends into the eye by about 1.5 mm to about 3 mm and into the subretinal space without contacting the retina.

[0273] In at least one embodiment, the needle actuator is controllable for advancing and retracting the needle, and the needle actuator is user-controlled.

[0274] In at least one embodiment, the fluid actuator is used to inject a therapeutic fluid, and the fluid actuator is user-controlled.

[0275] In at least one embodiment, the guiding 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 or a light polarization sensing device, an ultrasound imaging device, an acoustic reflection measurement device, and a handheld lens.

[0276] In at least one embodiment of the method, the device is defined according to any of the embodiments described herein.

[0277] On the other hand, in accordance with the teachings herein, at least one embodiment of a device having a needle for treating a patient’s eye is provided, wherein the device is defined according to any of the embodiments described herein.

[0278] On the other hand, in accordance with the teachings herein, a method is provided for injecting or draining fluid from a patient's eye, wherein the method comprises: positioning a probe defined according to a suitable embodiment described herein such that a lower surface of a distal end portion of the probe is pressed into the surface of the eye to be treated; extending a needle tip from the lower surface of the distal end portion of the probe to a desired depth in the eye, the needle extending approximately perpendicularly from the axis of the distal end portion of the probe; determining the depth of the needle tip using at least one sensor and / or a visual guidance tool; injecting or draining fluid from the eye when the needle tip is at the desired depth; and removing the needle from the eye.

[0279] In at least one embodiment, in accordance with the teachings herein, a stand-alone handheld device is provided for injecting or draining fluid into or from a patient's eye, wherein the device is shaped as a probe and includes: a body having a longitudinal axis and a distal end portion having a longitudinal axis angled or straight relative to the longitudinal axis of the body; one or more probe conduits for moving fluid through the probe; the distal end portion having a lower surface, a portion of which is placed adjacent to a surface of the eye during use; an extendable needle disposed at the distal end of the probe, the needle having a needle conduit fluidly coupled to one or more probe conduits for injecting or draining fluid into or from the eye, and the needle extending approximately perpendicularly away from the longitudinal axis of the distal end portion of the probe for penetration into 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 drainage of fluid.

[0280] In at least one embodiment, the device includes an input button configured to allow a user to configure the device to operate in either an injection mode or an expulsion mode.

[0281] In at least one embodiment, the device includes at least one sensor for measuring data related to the penetration depth of the needle tip during use.

[0282] In at least one embodiment, the device includes a light source for generating a guide beam that is transmitted from the distal end portion of the probe toward the eye during use.

[0283] In at least one embodiment, the device includes a microcontroller for controlling the operation of the device, the microcontroller being located within the probe.

[0284] In at least one embodiment, the device includes a power source.

[0285] In at least one embodiment, the device contains a therapeutic fluid container for providing therapeutic fluid during injection.

[0286] In at least one embodiment, the device includes a discharge pipe for receiving discharged fluid during use and a discharge port connected to the discharge pipe for removing the discharged fluid.

[0287] In at least one embodiment, the lower surface of the distal curved end portion has a radius of curvature and an arc length such that the radius of curvature is approximately the radius of curvature of the eye or sclera at the point of needle insertion and the arc length is predetermined based on the position where the needle will be inserted into the eye.

[0288] While the applicant's teachings described herein incorporate various embodiments for illustrative purposes, this does not mean that the applicant's teachings are limited to such embodiments. Rather, the applicant's teachings described and illustrated herein contain various substitutions, modifications, and equivalents without departing generally from the embodiments described herein. For example, although the teachings described and illustrated herein may include certain elements / components and steps, modifications can be made as known to those skilled in the art. For example, selected features of one or more example embodiments described herein may be combined to create alternative embodiments not explicitly described, based on the teachings herein. For example, as will be apparent to those skilled in the art, the devices and methods described herein can be implemented using other additional combinations and arrangements of the various features and functions presented, including shape, shape factors, needle position or orientation, conduit, adjustment, control, actuator, indicator, guiding element, fluid and other materials, surgical steps, and applications. All values ​​and sub-ranges within the disclosed scope are also disclosed. The subject matter described herein is intended to cover and encompass all suitable variations in the art.

[0289] refer to 1. Williams GA, Aaberg TA Jr. Scleral buckling technique. In: Ryan SJ, Wilkinson CP (eds.), Retina. Vol. 3. 4th ed. Elsevier Mosb; 2006: 2035-2207. 2. Moinuddin O, Abuzaitoun RO, Hwang MW, et al. Surgical repair of primary uncomplicated rhegmatogenous retinal detachment in the era of modern small-scale vitrectomy. BMJ Open Ophthalmology 2021;6(1):e000651. doi:10.1136 / bmjophth-2020-000651. 3. Heimann H, Hellmich M, Bornfeld N, Bartz Schmidt KU, Hilgers RD, Foerster MH. Comparison of scleral buckling and primary vitrectomy for rhegmatogenous retinal detachment (SPR study): design issues and significance. SPR study report no. 1. Graefes Clinical Ophthalmology Trials 2001; 239(8):567-574. doi:0.1007 / s004170100319. 4. Hillier RJ, Felfeli T, Berger AR, et al. A randomized trial (PIVOT) of pneumatic retinal fixation versus vitrectomy for primary rhegmatogenous retinal detachment. Ophthalmology 2019; 126(4):531-539. doi:10.1016 / j.ophtha.2018.11.014. 5. Brash K, Francisconi CLM, Qian J, et al. Comparison of retinal displacement after pneumatic retinal fixation and pars plana vitrectomy for rhegmatogenous retinal detachment. JAMA Ophthalmology 2020; 138(6):652659. doi: 10.1001 / jamaophthalmol.2020.1046. 6. Francisconi CLM, Marafon SB, Figueiredo NA et al. Pneumatic retinal fixation and vitrectomy for retinal displacement following 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. Pars plana vitrectomy and pneumatic retinal fixation for repair of extraretinal folds after retinal detachment: a post-hoc analysis from PIVOT. Journal of Ophthalmology and Retina 2022;6(3): 234-242. doi: 10.1016 / j.oret.2021.09.001. 8. Muni RH, Felfeli T, Sadda SR, et al. Comparison of photoreceptor integrity after pneumatic retinal fixation versus pars plana vitrectomy for retinal detachment: post-hoc optical coherence tomography analysis of a randomized trial of pneumatic retinal fixation versus vitrectomy for primary rhegmatogenous retinal detachment. AMA Ophthalmology 2021;139(6):620-627. doi: 10.1001 / jamaophthalmol. 2021.0803. 9. Bansal A, Naidu SC, Marafon SB, et al. Comparison of retinal shift after scleral buckling surgery with combined buckling and vitrectomy for rhegmatogenous retinal detachment: a comparison of scleral buckling and pars plana vitrectomy with scleral buckling. Published online in *Ophthalmology & Retina* on 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 - an ellipsoidal 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, MuniRH. Effect of tamponade on retinal displacement after pars plana vitrectomy for rhegmatogenous retinal detachment: a computer simulation model. Acta Ophthalmologica Sinica 10.1111 / aos.15118. 12. Lincoff H, Gieser R. Finding retinal holes. Arch Ophthalmology 971; 971;85(5):565-569. doi: 0.1001 / archopht. 1971.00990050567007. 13. Kempen JH. Appropriate use and reporting of uncontrolled case series in medical literature. American Journal of Ophthalmology 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 an eye, wherein the device comprises: The probe includes: The main body has a distal end portion; A needle that extends and retracts from an exit position on a side surface of the distal end portion, the needle having a needle guide; and One or more probe catheters for moving the fluid through the probe, the one or more probe catheters being fluidly connected to the needle catheter; During use, a portion of the side surface having the outlet location is placed on the surface adjacent to the eye, and the needle is extended to penetrate the eye, and the fluid is injected or discharged through the needle conduit.

2. The device of claim 1, wherein the needle is configured to exit the probe at the exit position substantially perpendicular to a tangent to the side surface.

3. The device according to claim 1 or claim 2, wherein the side surface is concave and its radius of curvature approximately matches the radius of curvature of the sclera.

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

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

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

7. The device according to any one of claims 1-6, wherein the side surface has a boss at the outlet location and the needle is configured to extend and retract through the boss, or the side surface has a boss adjacent to the outlet location and the needle is configured to extend and retract adjacent to the boss.

8. The device according to any one of claims 1-7, wherein the one or more probe catheters comprise an injection catheter and an discharge catheter, and the probe has a connector that is adjustable between fluidly connecting the discharge catheter to the needle catheter and fluidly connecting the injection catheter to the needle catheter.

9. The device according to any one of claims 1-8, wherein the device further comprises a guiding light source adapted to generate a guiding beam for illumination, or adapted to indicate when the tip of the needle penetrates different layers of the eye by means of variations in transmitted or reflected light.

10. The device according to any one of claims 1-9, wherein the device further comprises at least one guiding tool adapted to perform measurements to determine the location of the tip of the needle and / or a target injection or expulsion site in the eye.

11. The device according to any one of claims 1-10, wherein the device further comprises a control unit housed in or remotely from the probe, the control unit comprising: Optional display; Memory units store software instructions that perform one or more functions; A device interface for receiving measurement data and transmitting control signals for the operation of the device; A loudspeaker or vibrator that generates an audio signal or vibration corresponding to the device operating parameters and / or the measured data, wherein the loudspeaker or vibrator is optional; A processor communicatively coupled to any of the following: the memory unit, the interface, the speaker or vibrator, and the display, the processor being configured to perform one or more functions when executing software instructions, the one or more functions including: Receive the measurement data; Transmit the control signal; Generate the audio signal or vibration; and At least a portion of the measurement data is displayed on the display; as well as A power source, which provides power to the components of the device.

12. The device according to any one of claims 1-11, wherein the device comprises a pump fluidly connected to the one or more probe catheters, the pump being controllable to generate an injection pressure when the fluid is injected into the eye, or to generate an discharge pressure when the fluid is discharged from the eye.

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

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

15. The device according to any one of claims 1-14, further comprising an injection fluid container and / or an discharge fluid container coupled to the one or more probe catheters.

16. The device according to any one of claims 1-15, wherein the needle is adapted 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 1-15, wherein when the eye suffers from rhegmatogenous retinal detachment (RRD) or retinal tear, the device is adapted to inject fluid into the choroidal space of the eye to generate a choroidal clasp for treating RRD or retinal tear.

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

19. A method for injecting or draining a fluid into or from an eye, wherein the method comprises: The probe is placed with the side surface of the distal end portion adjacent to the surface of the eye, the probe having a needle with a needle guide and the needle being retracted; The needle extends from an exit position on the side surface of the distal end portion of the probe to penetrate the eye; and Fluid can be injected or drained between the probe and the eye via the needle catheter.

20. The method of claim 19, wherein the method includes extending the needle at the exit location substantially perpendicular to the side surface of the probe in a tangential manner.

21. The method according to any one of claims 19-20, wherein the side surface of the distal end portion of the probe is concave, and the radius of curvature of the concave surface approximately matches the radius of curvature of the sclera.

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

23. The method according to any one of claims 19-22, wherein the method comprises using a needle actuator to control the extension and retraction of the needle.

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

25. The method according to any one of claims 19-24, wherein the method comprises using a guide beam and / or measurements performed by a guide tool to determine the position of the tip of the needle and / or a target injection or drainage site in the eye.

26. The method according to any one of claims 19-25, wherein a control unit integrated or separate from the probe is used to display measurement data from the probe, transmit control signals to the probe, and / or generate audio signals or vibrations corresponding to device operating parameters and / or measurement data.

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

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

29. The method of any one of claims 19-27, wherein the eye suffers from rhegmatogenous retinal detachment (RRD) or retinal tear, and the method comprises injecting fluid into the suprachoroidal space (SCS) of the eye to generate a choroidal cingulate for treating RRD or retinal tear.

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