Intraocular optical coherence tomography apparatus and vitreoretinal surgery method

Abstract

An optical probe comprising: an optical fiber coupled to a movable actuator configured to direct light emitted from the optical fiber at a plurality of varying angles; and a relay lens distal to the movable actuator, the relay lens configured to receive the light emitted from the optical fiber and direct the received light to a sample.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is based on and claims priority to U.S. Patent Application No. 63 / 381,925 (filed November 1, 2022), the entire contents of which are incorporated herein by reference.

[0002] <Statement Regarding Federally Sponsored Research> none. [Background technology]

[0003] Optical coherence tomography (OCT) is a noninvasive imaging technique that uses light (e.g., infrared) to obtain high-resolution images of the interior of tissues. Intraoperative OCT (iOCT) utilizes OCT in the operating room during surgery, making it a valuable tool for surgeons in various ophthalmic procedures. In vitreoretinal surgery, instruments are placed inside the eye to operate on the posterior inner layer of the eye, where the retina resides. Intraoperative OCT is particularly useful during retinal surgery, clarifying the individual layers of the retina and aiding surgical decision-making. All current intraoperative OCT devices are extraocular, limiting their ability to image specific structures and guide surgical movements. Intraocular OCT, on the other hand, involves inserting an OCT probe directly into the eye. There are no clinically approved intraocular OCT devices, and few device designs exist. The few existing designs are all believed to lack design criteria for a robust, cost-effective, and scalable device, limiting clinical feasibility. Summary of the Invention

[0004] Therefore, new systems, methods, and devices are desired to solve a clinically feasible, cost-effective, and scalable intraocular optical coherence tomography device for vitreoretinal surgery.

[0005] The development of OCT has revolutionized the practice of ophthalmology, including our understanding and clinical management of numerous ocular diseases. These advances have led to the introduction of OCT into intraoperative settings, where it is considered a valuable tool for a variety of ophthalmic procedures, particularly in vitreoretinal surgery, due to its ability to define individual layers and lesions within the retina. The integration of this technology into instruments (intraocular OCT) offers certain advantages over existing intraoperative OCT devices that image the retina from outside the eye. In particular, intraocular OCT can enable guidance of surgical procedures and improve intraoperative diagnosis, better supporting surgical decision-making and paving the way for future technologies and advancements in the field.

[0006] With traditional intraoperative OCT, extraocular images cast shadows on surgical instruments, hindering the ability to guide surgical movements. Obtaining high-quality images often requires removing and reinserting instruments. In contrast, intraocular OCT probes enable direct imaging in conjunction with surgical instruments already inserted inside the eye. Thus, guidance of surgical procedures, particularly for submacular surgery such as gene therapy, could be significantly improved by intraocular OCT.

[0007] Furthermore, any media opacity, such as corneal edema, advanced cataract, or other anterior segment disease, and intraocular opacities, such as vitreous hemorrhage or advanced vitritis, cloud the images acquired with conventional extraocular OCT. Using an intraocular OCT probe, the retina is imaged directly, and images are not affected by media or intraocular opacities.

[0008] Compared with intraoperative OCT, intraocular OCT may allow for better visualization of peripheral structures within the retina due to the ability to adjust the probe to image the far periphery, which may allow for visualization of asymptomatic retinal cracks and improve the outcome of retinal detachment surgery.

[0009] In cases of preretinal membrane detachment, dyes are often used to delineate the membrane boundaries. Intraocular OCT allows direct visualization of the preretinal membrane, allowing for proper detachment and reducing the need for dyes, which can have toxic effects.

[0010] Overall, precision for a wide array of surgical procedures in vitreoretinal surgery, as well as other ophthalmic fields and microsurgical fields, would be improved by having a linear scanning OCT probe small enough to be inserted directly into the surgical field.

[0011] Few intraocular OCT devices have been developed to date, and all are believed to lack design criteria that enable clinically feasible, cost-effective, and scalable devices. Therefore, novel intraocular device embodiments disclosed herein offer advantages over conventional devices and may pave the way for the use of intraocular OCT in vitreoretinal and other ophthalmic procedures. The devices disclosed herein have the potential to impact the field of vitreoretinal surgery and improve patient outcomes in both common and uncommon vitreoretinal procedures. Furthermore, the devices described herein may be used in other ophthalmic surgical fields, such as anterior segment, oculoplastic, and neuro-ophthalmology, as well as other surgical fields, such as neurosurgery and ENT, and other surgical fields utilizing microsurgical techniques. Furthermore, surgical or medical fields that can benefit from forward-looking, linear scanning, high-resolution imaging with OCT probes may benefit, particularly in tumor surgical resection.

[0012] Compared to known intraocular OCT probes, the disclosed device combines a novel optical design with a novel mechanical design. To the inventors' knowledge, no prior intraocular OCT device utilizes a microelectromechanical (MEMS) micro-scanning mirror system. This system is scalable compared to conventional actuators and enables 3D volumetric imaging, which has been reported with prior actuator systems for intraocular OCT.

[0013] A novel mechanical design is also disclosed that optimizes the device for clinical feasibility, reusability, cost-effectiveness, and scalability. A key aspect of this design is that the distal cap, which contains the optical element inserted into the eye, is removable, making it a disposable item, while the remaining components adjacent to it are reusable. This allows the expensive areas of the device (actuator, fiber collimator, and electrical components) to be reused repeatedly in clinical settings, while the disposable nature of the intraocular components ensures a high level of hygiene and safety. The disposable cap significantly reduces the possibility of causing an infection within the eye or transmitting infections such as prion diseases from one patient's eye to another.

[0014] Another novel aspect of this design is the delivery of collimated light from the handpiece to the probe tip. To the inventors' knowledge, known intraocular OCT devices do not deliver collimated light to the probe tip, but instead use a single-mode fiber to deliver light from the handpiece to the probe. Our collimated light relay design makes the probe more clinically feasible, durable, and reusable.

[0015] The mechanical design for centering the fiber collimator, MEMS, GRIN lens, and other optical elements is custom designed for the device. The optics at the distal end of the device may include a long relay lens based on a GRIN lens design, which has not been described in known intraocular OCT devices.

[0016] In addition to the aspects described above, the device can include one or more of the following features: In some embodiments, the device can include a relay lens including stacked GRIN lenses, multiple GRIN lenses at the distal end, and / or a custom single GRIN lens at the distal end. In other embodiments, the device can include a single-mode (SM) fiber extending through a support structure (e.g., a hypotube or needle), a ball lens optic at the distal end, and / or a relay lens including multimode fiber optics. In yet other embodiments, the device can include a relay lens including multimode GRIN fiber instead of a relay lens.

[0017] In addition to the disclosed MEMS-based scanning mechanisms, possible actuator designs include rotary motors and / or miniature galvanometer devices, piezoelectric actuators, the use of electromagnetic and / or shape memory alloys, electrostatic, or electrothermal mechanisms.

[0018] Other improvements provided by embodiments of the disclosed devices include an increased field of view due to an umbrella design at the distal tip, an increased field of view due to a balloon that can be filled with saline or other substances (e.g., ferrofluid, silicone, air, or gas), the use of dyes to indicate locations on tissue (retina or other tissue) to which the OCT device is guided during surgery, simultaneous white, blue, or other spectral light imaging in addition to OCT imaging, the use of curved or angled probes, optimization of probes and OCT techniques to image through one or more of air, oil, or gas, the use of probes configured to safely contact retinal tissue without damaging the retina, the use of probes where laser treatment of tissue is performed through the same probe used for imaging, the use of probes optimized with improved optics for other forms of ophthalmic surgery (including, but not limited to, corneal surgery, oculoplastic surgery, neuro-ophthalmology, strabismus surgery, pediatric surgery, and / or glaucoma surgery), or other surgical disciplines such as neurosurgery or otolaryngology, surgeries utilizing microsurgical techniques, or surgeries requiring high-resolution tissue imaging such as cancer resection or surveillance. Each of these applications within other areas of ophthalmology and other surgical or medical fields is expected to be a direct adaptation of the described technology. In some cases, the exact same probe with the same specifications may be used. In other cases, small improvements such as adjusting the working distance or improving the optics (GRIN lens) to increase the field of view, possibly at the expense of diameter and resolution, will be improvements to existing designs that will enable the device to be suitable for other surgical or medical procedures.

[0019] In various embodiments, previously described applications of intraocular OCT that can be achieved with this design include simultaneous surgical procedures that may be guided and assisted by the device, including one or more of the following: use of microforceps, laser treatment, injection, cryotherapy, biopsy, aspiration, peeling and splitting, posterior vitreous detachment induction, dye injection, or cutting.

[0020] Some embodiments provide for optimization of the device for imaging pediatric patients and use in anterior segment surgery and other ophthalmic fields. Still other embodiments provide integration with heads-up visualization devices, motion compensation, surgical step guidance, smart detection and instrument tracking and artificial intelligence, integrated working ports or blades, and / or the ability to insert probes into the working channels of other devices.

[0021] Various embodiments provide an optical probe and a method of operating an optical probe, the optical probe including an optical fiber coupled to a movable actuator that can be configured to transmit light emitted from the optical fiber at a plurality of varying angles, and a relay lens distal to the movable actuator that is configured to receive the light emitted from the optical fiber and transmit the received light to a sample. The method includes providing an optical fiber coupled to a movable actuator, transmitting the light emitted from the optical fiber at a plurality of varying angles, receiving the light emitted from the optical fiber with the relay lens distal to the movable actuator, and transmitting the received light to a sample.

[0022] In some embodiments, the multiple angles can include angles of up to 3.75 degrees on either side of the optical axis. In other embodiments, the multiple angles can include angles of up to 5 degrees or 10 degrees on either side of the optical axis. The optical axis can be scanned at different angles depending on the design and MEMS mirror used. For example, MEMS mirrors typically range in size from 2 to 7.5 mm, among others, and have variable angles, often ranging from -7 to +7 degrees. Different MEMS mirrors can be used depending on the size of the desired probe. The angle at which the MEMS mirror bends the light is related to the size of the probe and the desired field of view, which is optimized according to optical modeling. For example, for a 25-gauge probe with a 1 mm FOV, our optical modeling results show that a 0.8-degree scan angle on either side of the optical axis for the MEMS mirror results in a 5-degree scan angle at the end of the probe. In addition to MEMS mirrors, other actuators can be used as described above, including electromagnetic actuators, micromotors, and piezoelectric actuators, among others, which can enable scanning at different angles regardless of the probe size, desired field of view, and clinical application.

[0023] In various embodiments, the optical probe may further include a fiber collimator disposed at a distal end of the optical fiber, a fixed reflective surface disposed distally relative to the fiber collimator, and an adjustable reflective surface coupled to the movable actuator and disposed adjacent to the fixed reflective surface. The adjustable reflective surface may be configured to reflect light emitted from the fiber collimator and reflected by the fixed reflective surface at the plurality of varying angles. The relay lens may be configured to receive the light reflected from the adjustable reflective surface and send the received light to the sample.

[0024] In certain embodiments, the movable actuator may comprise at least one of a microelectromechanical systems (MEMS) device, a galvanometer, or a rotary motor.

[0025] In some embodiments of the optical probe, the relay lens is disposed within a distal cap, and the distal cap and the relay lens may be removable from the optical probe.

[0026] In different embodiments, the relay lens can include an objective lens at a distal end of the relay lens. In some embodiments, the relay lens includes a GRIN lens. In certain embodiments of the optical probe, the GRIN lens can include multiple stacked GRIN lenses. In certain embodiments of the optical probe, the relay lens can be a curved or angled probe, and the relay lens can include at least one of a prism or an angle-polished GRIN lens configured to direct light through the curved or angled probe.

[0027] In some embodiments, the optical probe may further comprise a telecentric lens disposed between the movable actuator and the relay lens, the telecentric lens configured to focus light emitted from the optical fiber onto a proximal end of the relay lens.

[0028] In different embodiments of the optical probe, the movable actuator can rotate on a first axis to scan the received light across the surface of the sample in a first direction. In other embodiments of the optical probe, the movable actuator can rotate on a second axis perpendicular to the first axis to scan the received light across the surface of the sample in a second direction perpendicular to the first direction.

[0029] In different embodiments of the optical probe, the fixed reflective surface can include at least one of a mirror or a prism.

[0030] In certain embodiments of the optical probe, the optical fiber and the movable actuator can be disposed within a hand piece. In some embodiments of the optical probe, the hand piece can include a lower portion and an upper portion, and the optical fiber and the movable actuator can be disposed in the lower portion of the hand piece to facilitate optical alignment, and the upper portion of the hand piece can be fixed to the lower portion of the hand piece. In certain embodiments of the optical probe, the hand piece can further include a plurality of adjustment mechanisms provided for at least one of the optical fiber and the movable actuator, and the plurality of adjustment mechanisms can be configured to facilitate the optical alignment. In certain embodiments of the optical probe, the hand piece can be disposed within an external housing.

[0031] In some embodiments of the optical probe, the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface can be disposed within the hand piece. In some embodiments of the optical probe, the hand piece can include a lower portion and an upper portion, and the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface can be disposed in the lower portion of the hand piece to facilitate optical alignment, and the upper portion of the hand piece can be fixed to the lower portion of the hand piece. In certain embodiments of the optical probe, the hand piece can further include multiple adjustment mechanisms provided for at least one of the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface, and the multiple adjustment mechanisms can be configured to facilitate the optical alignment. In certain embodiments of the optical probe, the hand piece can be disposed within an external housing.

[0032] In different embodiments of the optical probe, the relay lens can be disposed within a hypotube. In some embodiments of the optical probe, the hypotube can have a plurality of passages, and the relay lens can be disposed within a first of the plurality of passages. In certain embodiments of the optical probe, the plurality of passages can include at least two passages separated by a partition. In certain embodiments of the optical probe, the plurality of passages can include a plurality of concentric passages, and the relay lens can be disposed within a first central passage. In some embodiments of the optical probe, a second external passage can include at least one of a cutting blade, a suction port, an air delivery port, a fluid delivery port, or a drug delivery port.

[0033] In certain embodiments, the optical probe can further include an OCT (optical coherence tomography) system coupled to the optical fiber. In different embodiments of the optical probe, the OCT system can further include an OCT light source coupled to the optical fiber. In certain embodiments, the optical probe can further include a white light source coupled to the optical fiber.

[0034] In different embodiments of the optical probe, the sample can include a retina.

[0035] A more complete understanding of the various objects, features and advantages of the presently disclosed subject matter can be obtained by considering the following detailed description of the presently disclosed subject matter in conjunction with the following drawings, in which like reference numerals refer to like elements. [Brief explanation of the drawings]

[0036] [Figure 1] Panel A is a photograph showing an instrument inserted into an eye during vitreoretinal surgery. Panel B shows an instrument inserted into the eye that allows for a surgical procedure to be performed on the retina, located at the back of the eye, and includes a light source and an intraocular optical coherence tomography (OCT) probe. [Figure 2] FIG. 10 illustrates how the intraocular OCT probe of panel B of FIG. 1 is used during vitreoretinal surgery. The intraocular OCT probe includes a monitor containing an optical probe image and an OCT image, an OCT probe, a swept-source OCT system, and a power supply for the actuator and light pipe. [Figure 3] The left panel is a photograph showing how a video endoscope is used in vitreoretinal surgery, including a light pipe image of the retinal surface, an endoscopic image, a split-screen view, a microscope, an intraocular video endoscope, and an optical fiber transmitting white light. The right panel is a photograph showing how an OCT probe is used in vitreoretinal surgery, including an OCT image, a light pipe image of the retinal surface, a split-screen view, a microscope, an intraocular OCT probe, and an optical fiber transmitting 1060 nm light. [Figure 4] Panel A shows the optical design and specifications for the intraocular OCT probe of Figure 1B, including a relay lens and an objective lens. Panel B shows possible optical designs for the intraocular OCT probe of Figure 1B, including a custom GRIN lens (1), a design using three off-the-shelf GRIN lenses (2), a single-mode (SM) fiber or collimated light combined with multiple stacked and polished off-the-shelf GRIN lenses (3), and a combination of one relay lens and an objective lens (4). Panel C shows the handpiece optics and intraocular laser, with the handpiece including a scanning mirror. [Figure 5] Panel A shows the intraocular OCT device design using a microelectromechanical systems (MEMS) scanning system, showing the distal cap and relay lens as single-use components. Panel B shows the intraocular OCT device design, including the insert highlighting the fiber collimator and MEMS device. [Figure 6]Panel A shows a lateral three-dimensional rendering of the mechanical design of the intraocular OCT probe. Panel B shows a three-dimensional cross-sectional rendering of the intraocular OCT probe showing the placement of the fiber collimator, prism, and MEMS mount. Panel C shows a three-dimensional cross-sectional rendering of the intraocular OCT probe with strain relief, proximal cap, fiber collimator, prism, and MEMS mirror. [Figure 7] Panel A shows the bottom half of the intraocular OCT probe body, showing the V-grooves for optical alignment of the fiber collimator, MEMS holder, set screws, and holders for the GRIN lens and telecentric lens. Panel B shows the bottom half of the intraocular OCT probe body, showing how the fiber collimator sends a beam of light to a fixed reflector (right-angle mirror), which then reflects off the MEMS mirror toward the GRIN lens located inside the hypotube. Panel B shows the bottom half of the intraocular OCT probe body, showing how the beam emitted from the fiber collimator reflects off the fixed reflector (flat mirror), then reflects off the movable mirror (MEMS mirror), and is sent to the relay lens toward the sample. [Figure 8] Diagram showing the alignment of optical components inside an intraocular OCT probe, showing how the beam from the collimator reflects off a right-angle mirror, through a telecentric lens to a MEMS mirror, and then onto a hypotube containing a relay lens. [Figure 9] Panel A shows a side perspective view (left panel) and a front view (right panel) of a telecentric lens holder with three contacts for optimal positioning of the telecentric lens within the lens holder. Panel B shows a front view (left panel) and a back view (right panel) of a telecentric lens holder with three contacts for optical positioning, showing the back loading opening for the hypotube to show how the hypotube and telecentric lens holder are mounted relative to each other. [Figure 10]Panel A is a side perspective view of the assembled lower and upper housing pieces of the intraocular OCT probe body, highlighting the upper "clamshell" component. Panel B is a distal cutaway view of the intraocular OCT probe, including the lower clamshell, upper clamshell, and the outer cosmetic handpiece that can be placed into the assembled clamshell components. [Figure 11] Panel A shows a configuration of the external "surface" components of the intraocular OCT probe of Panel B of Figure 10, which transitions from the probe body / handpiece to the hypotube with a strain relief in between, using a rigid tube configuration. Panel B shows another configuration of the external "surface" components of the intraocular OCT probe of Panel B of Figure 10, which transitions from the probe body / handpiece to the hypotube with a strain relief in between, using an ergonomic handle configuration. [Figure 12] Panel A shows the optical modeling of the entire intraocular OCT probe. Panel B shows the optical modeling of the distal tip of the intraocular OCT probe. Panel C shows the optical modeling of the relay lens, which includes multiple stacked GRIN lenses, of the intraocular OCT probe. [Figure 13] Optical modeling (left panel) is shown to estimate the beam spot size and field of view (FOV) at the center of the FOV (0 mm) and at the edge of the FOV (+0.5 mm) using a probe with a fiber collimator, a plane mirror, a MEMS mirror, and a GRIN lens. [Figure 14] Panel A (option 1) shows the optical modeling of a probe with a single 0.35 mm outer diameter GRIN rod lens. Panel B (option 2) shows the optical modeling of a probe with a single 0.35 mm outer diameter GRIN rod lens and a telecentric coupling lens. Panel C (option 3) shows the optical modeling of a probe with a relay lens, which includes a relay GRIN lens and an objective GRIN lens. [Figure 15] Panel A (Option 1) shows the optical modeling of the proximal optical system with one GRIN rod lens of the probe in Panel A (Option 1) of Figure 14. Panel B (Option 2) shows the optical modeling of the proximal optical system with one GRIN rod lens and a telecentric coupling lens in Panel B (Option 2) of Figure 14. [Figure 16] FIG. 10 shows optical modeling of the output spot size of a probe with one relay lens and no objective lens; the insert shows a focus pass row of spots at different focus levels at points off-axis (top row) or on-axis (bottom row). [Figure 17A] FIG. 1 shows data relating to the tolerability analysis of each device component of the intraocular OCT probe. [Figure 17B] FIG. 1 shows data relating to the tolerability analysis of each device component of the intraocular OCT probe. [Figure 18] Data on system throughput and back reflection analysis for an intraocular OCT probe shows that the one-way total transmittance is approximately 85% and the total back reflection collection rate is 0.0275%. [Figure 19] Panel A shows an intraocular OCT device design using a MEMS scanning system as the moving actuator. Panel B shows an intraocular OCT device design using a single fiber actuator as the moving actuator. Panel C shows an intraocular OCT device design using a rotary motor or galvanometer scanning system as the moving actuator. [Figure 20] 1 shows an intraocular OCT device design that houses a rotary motor that extends beyond the surface of the housing by modifying the intraocular OCT probe handpiece design, with a distal cap and hypotube / relay lens attached to the top panel and the distal cap and hypotube / relay lens spaced from the body of the probe in the bottom panel. [Figure 21]FIG. 1 shows a curved or angled probe design that can be used to image the peripheral retina as shown in the left panel, and the right panel shows components such as angle-polished GRIN lenses or prisms that can be included in the relay lens to send light on a curved or angled path in the curved or angled probe design. [Figure 22] Figure 1 shows a probe design for simultaneous white light and OCT imaging, with a white light source and an infrared light source coupled to the OCT probe. The top panel shows the basic system schematic, and the bottom panel includes an insert showing the probe insertion into the eye and example white light and OCT images. [Figure 23] Panel A shows a multi-channel intraocular OCT probe design with an OCT lens or fiber in the central passageway and one or more outer passageways for application of one or more of suction, air, infusion fluid, or medication. Panel B shows a multi-channel intraocular OCT probe design with an OCT lens or fiber in the central passageway and one or more outer passageways for application of biopsy or cutting blades. Panel B shows a multi-channel intraocular OCT probe design with partitions between passageways and an OCT lens or fiber in one of the passageways, with a second passageway available as a working port. DETAILED DESCRIPTION OF THE INVENTION

[0037] In some embodiments of the presently disclosed subject matter, mechanisms (including systems, methods, and apparatus) are provided for solving a clinically feasible, cost-effective, and scalable intraocular optical coherence tomography device for vitreoretinal surgery.

[0038] The development of optical coherence tomography (OCT) has revolutionized the practice of ophthalmology, significantly changing the understanding and clinical management of many ocular diseases. Intraocular OCT has certain advantages over current intraoperative OCT devices, particularly in assisting surgical procedures to guide submacular surgery, including gene therapy.

[0039] Optical coherence tomography (OCT) began in the 1980s as a collaborative research project between Massachusetts Eye and Ear Infirmary, Harvard Medical School, and Massachusetts Institute of Technology. Since then, OCT has revolutionized the field of ophthalmology. Today, OCT has become the standard of care in the management of various eye diseases, particularly retinal diseases.

[0040] Intraoperative optical computed tomography (iOCT), the use of optical computed tomography (OCT) in the operating room during surgery, was first implemented in 2005 by attaching a beam splitter to the front of a surgical microscope. To date, various iOCT devices, including handheld and microscope-integrated OCT, exist and are routinely used in many types of ophthalmic surgery. Evidence from clinical trials suggests that iOCT benefits vitreoretinal surgery, with the DISCOVER trial demonstrating that iOCT altered decision-making in 29% of posterior segment surgeries and the PIONEER trial demonstrating that it altered decision-making in 46% of membrane peel cases. While these studies demonstrate the impact iOCT has on vitreoretinal surgery, current iOCT devices have important limitations. During vitreoretinal surgery, instruments are placed inside the eye (vitreous cavity) and manipulated on the tissue of interest, in this case the retina (Figure 1). Current iOCT devices operate outside the eye, which can create artifacts that interfere with accurate imaging and complicate coordination of instrument movement with OCT visualization. Furthermore, the application of these procedures to patients with media opacities, such as corneal clouding or advanced cataracts, remains challenging. Furthermore, visualization of the far periphery of the retina with microscope-integrated iOCT is not feasible due to optical aberrations and wide focal differences. In this regard, clinical studies suggest that iOCT offers the most value in complex cases, and these same complex cases are more likely to have media opacities and require imaging of the peripheral retina.

[0041] An endoscopic OCT probe inserted directly into the eye would limit the aforementioned challenges of external iOCT. Furthermore, an intraocular endoscopic OCT probe would have the additional ability to directly guide surgical procedures. Intraocular OCT has numerous potential clinical applications, ranging from routine vitreoretinal surgery to recent and future advances in the field, such as gene therapy. During pars plana vitrectomy (PPV), a procedure performed by vitreoretinal surgeons on nearly every patient, intraocular OCT probes can be used to confirm the completeness of posterior vitreous detachment and removal of peripheral vitreous, helping to prevent postoperative complications. Today, preretinal membrane (ERM) detachment is indicated by fluorescent dyes, which can be toxic if trapped beneath the retina. By directly visualizing the most viable location for detachment initiation and the presence of residual preretinal tissue, intraocular OCT can avoid the need for dyes and ensure complete removal of the ERM. During retinal detachment repair, intraocular OCT can be used to identify residual subretinal fluid, ruptures, residual perfluorocarbon fluid, and early proliferative vitreoretinopathy. This is evident in the DISCOVER trial, where iOCT changed decision-making in 29% of posterior segment surgeries, and in 46% of membrane peel cases in the PIONEER trial. Intraocular OCT can be used to identify vitreomacular traction and fibrous tissue in cases of endophthalmitis during macular hole surgery and during subretinal and choroidal biopsies. Subretinal surgery is an exciting area where intraocular surgery may aid in new techniques in this field, such as AAV2-REP1 for chorioretinopathy, retinal prosthesis implantation (e.g., Argus II), and subretinal plasminogen activator injections for submacular hemorrhage. In particular, optimizing bleb formation during gene augmentation therapy has become important due to recent reports of perifoveal chorioretinal atrophy after subretinal injection of the voretigene neparvovecrzyl.

[0042] However, the application of intraocular OCT is not limited to the posterior segment. In anterior segment surgery, intraocular OCT can assist glaucoma surgeons during external and internal procedures to better visualize the trabecular meshwork structure and uveoscleral pathway. During corneal transplantation, intraocular OCT can aid in the adhesion of posterior lamellar keratoplasty and help bypass the air-tissue interface, especially when subepithelial and anterior stromal opacities are present. Intraocular OCT may also be useful in complex cataract surgery and various pediatric ophthalmic procedures.

[0043] A few intraocular OCT devices have been described. Nearly all were tested on ex vivo animal tissue, and only two devices were used in multiple human patients. One of the devices was a commercially available intravascular OCT probe that acquired images in a circular format and was therefore not optimized for retinal imaging. Another study evaluated the feasibility of an iOCT-based sensor to assist robotic vitreoretinal surgery. The device was tested in five vitreoretinal cases and was able to perform almost all predefined surgical tasks, including inserting and moving instruments and testing virtual boundaries. Nevertheless, further improvements are desirable.

[0044] Thus, disclosed herein are embodiments of a novel intraocular OCT device optimized for vitreoretinal surgery. The disclosed device design embodiments overcome certain limitations of previous devices and suggest the potential for large-scale manufacturing and clinical feasibility.

[0045] Figure 1A is a photograph showing the insertion of instruments into an eye undergoing vitreoretinal surgery. Vitreoretinal surgery may include a vitrectomy 2 or cannula 4, which are used to maintain a closed space, reduce infusion fluid, and maintain intraocular pressure during surgery. An optical probe 6 configured to illuminate the retina and vitreous cavity during surgery may also be included. Vitreoretinal surgery may further include an intraocular optical coherence tomography (OCT) probe to ensure precise anatomical subretinal delivery and provide immediate feedback to the surgeon after intraoperative manipulation.

[0046] 1B is a diagram illustrating how instruments may be inserted into the eye to assist in a surgical procedure at the retina 12 (located at the back of the eye, showing blood vessels 10 and the vitreous body 8), including an optical probe 6, which, according to embodiments disclosed herein, may further include an intraocular optical coherence tomography (OCT) probe. In some embodiments, the OCT probe may be configured to enable three-dimensional volumetric imaging.

[0047] During surgery, an intraocular OCT probe is inserted through a 25-gauge or similar vitrectomy port, similar to those routinely used for the insertion of other vitreoretinal devices (Figure 2). The probe is connected to the OCT system and power source, and OCT images are then projected onto a split-screen monitor in the operating room or an external monitor (Figure 2). Various types of OCT systems exist and can be used in conjunction with the device, including time-domain, spectral-domain, and swept-source OCT. OCT systems in ophthalmology have evolved, and most are now spectral-domain or swept-source-based systems. Swept-source OCT systems are preferred due to the established advantages of SS-OCT, which produces higher sensitivity, a lower signal-to-noise ratio, and higher-quality OCT images compared to SD-OCT. Furthermore, the central wavelength of 1060 nm for commonly available SS-OCT has less absorption through water than typical wavelengths used in SD-OCT (see optical modeling in Figures 12-16). FIG. 2 illustrates an embodiment of an intraocular OCT probe system 14 used during vitreoretinal surgery, including a monitor 22, an optical probe / pipe 6, a swept-source OCT system 20, and a power supply for an actuator 18. During surgery, a distal portion (e.g., a relay lens) of the intraocular OCT probe 16 is inserted into the eye via hypotube or a 25-gauge (or similar) vitrectomy port. The OCT probe 16 is connected to the swept-source OCT system 20 and power supply 18, allowing OCT images to be acquired and displayed on a split-screen monitor in the surgical field or on an external monitor. The split-screen monitor is configured to display a white-light image 24 of the retinal surface and / or an OCT image 26.

[0048] The procedure for using the disclosed intraocular OCT probe is similar to existing procedures for using endoscopic video imaging probes in vitreoretinal surgery, except that instead of or in addition to transmitting white light, the fiber and optical probe transmit white and / or infrared light (e.g., 1060 nm), and the images include high-resolution OCT and / or white-light images (Figure 3). The left and right panels of Figure 3 contrast the use of a conventional video endoscope (left) and the disclosed intraocular OCT probe (right) in vitreoretinal surgery. The left panel of Figure 3 is a photograph showing how a video endoscope is utilized in vitreoretinal surgery, including a split-screen view 30 that includes a light-pipe image 24 and an endoscopic image 28 of the retinal surface. The surgical setup further includes a microscope 32, an intraocular video endoscope 34, and an optical fiber 36 that transmits white light.

[0049] The right panel of Figure 3 is a photograph illustrating how an OCT probe is utilized in vitreoretinal surgery, including a split-screen view 30 that includes a high-resolution OCT image 26 and a light-pipe image 24 of the retinal surface. Also included is a microscope 32, an intraocular OCT probe 16, and an optical fiber 38 that transmits infrared (e.g., 1060 nm) light. In various embodiments, the infrared light for OCT may be combined with white light to obtain a white-light image along with the OCT image. Compared to using a video endoscope during vitreoretinal surgery, the endoscopic image is replaced with a high-resolution OCT image, the intraocular video endoscope is replaced with an intraocular OCT probe, and the optical fiber transmitting white light is replaced with an optical fiber transmitting 1060 nm light.

[0050] Device specifications and safety concerns were carefully considered after reviewing previous and existing OCT devices, potential clinical applications, and the ANSI Z136.1 standard for laser safety. In various embodiments, the outer diameter of the probe tip (e.g., relay lens) will fit into a 25-gauge port (0.51 mm) or similar hypotube, or other port sizes such as a 23-gauge port depending on the specific procedure. The probe tip length will be in the range of 25–30 mm, taking into account the axial length of the eye (Figure 4). The target lateral resolution will be 25 microns, and the optical axial resolution will be 8.3 microns or less. The ranging depth will be 1.765 mm, the penetration depth will be 0.90 mm, and the field of view will be at least 1 mm. The working distance will be approximately 5 mm, maximizing image quality while avoiding physical or radiation damage to the retina during the procedure. The scan type will be linear, which is common for retinal imaging. Imaging may be performed with 1060 nm light, which is typically used for swept-source OCT retinal imaging, although other light sources such as 1310 nm light are also possible.

[0051] Figure 4A shows the optical design and specifications for an intraocular OCT probe, including a relay lens and an objective lens. The relay lens is configured to copy an image of the retina from the proximal end to the distal end of the OCT probe, and the objective lens focuses the light at the desired working distance. Figure 4B shows possible optical designs for the intraocular OCT probe of Figure 1B, including a custom GRIN lens (1), a design using three off-the-shelf GRIN lenses (2), an SM fiber or collimated light combined with multiple stacked and polished off-the-shelf GRIN lenses (3), and a combination of a relay lens and an objective lens (4). Figure 4C shows a diagram of the intraocular handpiece optics and laser. The handpiece includes a fiber collimator and a scanning mirror. The eye contains the retina and OCT scan.

[0052] The entire device includes two main components: (1) a reusable handpiece containing sterilization-resistant components and (2) a disposable tip containing a distal cap and focusing and relay optics (Figures 5 and 6). In the reusable handpiece, light from the OCT system travels through an optical fiber and is converted by a fiber collimator to propagate unidirectionally as a collimated beam in free space (Figures 5A and 5B). This light is reflected by a fixed reflector (e.g., a mirror or prism) to a movable reflector, such as a microelectromechanical systems (MEMS) mirror (Figures 5A and 5B). MEMS-controlled mirrors are particularly suitable because they enable rapid 2D or 3D optical scanning by deflecting a laser beam at the desired optical scanning angle. The MEMS mirror then scans the light toward the optical system, ultimately reaching the retinal tissue (Figures 5A and 5B). In various embodiments, the MEMS mirror is the final optical component in the reusable handpiece.

[0053] 5A and 5B are mechanical diagrams of an embodiment of an intraocular OCT device design, specifically using a MEMS scanning system to move a movable reflector. In other embodiments, a single fiber actuator and / or a rotary motor or galvanometer scanning system can be used to move the movable reflector. FIG. 5A shows a mechanical illustration of an intraocular OCT device design using a MEMS scanning system, showing a strain relief, proximal cap, holder, fiber collimator, MEMS mount including a MEMS mirror, and a fixed or stationary flat mirror. The microelectromechanical system (MEMS) mirror enables rapid two-dimensional or three-dimensional optical scanning. The MEMS mirror is configured to deflect the laser beam to the desired optical scan angle within a range of + / - 5 degrees, although a wider range of deflection is also possible. The intraocular OCT device further includes a disposable distal section including a distal cap and a relay lens and an objective lens. The relay lens may be inserted into a 25-gauge tube or similar hypotube for insertion into the eye. As shown in Figure 5A, the proximal end of the relay lens can be close to the MEMS mirror (e.g., within about 0.125 mm) to guide the reflected light to the end of the relay lens. Considering that the light is collimated, other distances (e.g., between the collimator and the fixed reflector, and between the fixed reflector and the movable reflector) are flexible.

[0054] 6A-6C show different cross-sectional three-dimensional renderings of the mechanical design of the intraocular OCT probe 16. Figures 6A and 6B show cross-sectional three-dimensional renderings of the mechanical design of the intraocular OCT probe, including the fiber collimator 44, the fixed reflector 48, and the MEMS mirror 46. Figure 6C shows a cross-sectional three-dimensional rendering of the mechanical design of the intraocular OCT probe, including the strain relief 40, the proximal cap 42, the fiber collimator 44, the fixed reflector 48, and the MEMS mirror 46.

[0055] The handpiece may include various components to aid in proper optical alignment and improve ease of manufacturing. A handpiece can include an upper and lower half in a single design. Figures 7A-7C show different mechanical models of the lower half of an OCT probe body. The lower half of the handpiece is configured with optical alignment components that allow for precise alignment and testing before closure of the device. Figure 7A shows a mechanical model of the lower half of an intraocular OCT probe body, showing the V-groove for optical alignment, including the collimator V-groove, area for MEMS wires, MEMS holder, set screw, and GRIN / telecentric holder. In the event of optical misalignment, various embodiments provide adjustment mechanisms, such as set screws, associated with specific components, such as the fiber collimator or telecentric lens, to enable precise three-point alignment to achieve the desired alignment and resolution after the components are assembled. Figure 7B shows a mechanical model of the lower half of the body of an intraocular OCT probe, including the collimator, beam, right-angle mirror, microelectromechanical system (MEMS), and GRIN within the hypotube, projecting a beam into the optical system. Figure 7C shows a mechanical model of the lower half of the body of an intraocular OCT probe, including the microelectromechanical system (MEMS), right-angle mirror, collimator, and beam, projecting a beam into the optical system and showing a close-up image of the beam reflecting off the surface.

[0056] In certain embodiments, the optical design of the disposable cap may include a telecentric lens to focus the scanning beam onto the proximal end of the relay lens (e.g., a GRIN lens that is part of the relay lens; see Figures 8 and 9). Because the relay lens is the only optical component that enters the eye and serves to relay and focus the light into the eye at the desired working distance, it is important to properly guide the light from the MEMS mirror to the proximal end of the relay lens. Figure 8 shows a mechanical model illustrating the alignment of the optical components inside the intraocular OCT probe, including areas for wires, collimators, beams, right-angle mirrors, and microelectromechanical systems (MEMS) mirror surfaces. Figure 9A shows a mechanical model of a telecentric lens holder with three-point contact for optimal positioning, providing an embodiment of a telecentric lens holder design for use with an intraocular OCT probe. Figures 9B and 9C show front and back views of an embodiment of a telecentric lens holder, illustrating how a hypotube is inserted into an opening on the back of the telecentric lens holder and connected to the telecentric lens holder.

[0057] As noted above, in various embodiments, the handpiece may include two components: a lower portion or "clamshell" where the optical components are initially positioned for alignment, and an upper portion or "clamshell" that encloses the optics, which are enclosed in the cosmetic handpiece (FIG. 10). FIG. 10A shows a side view of a mechanical model of the upper housing of the body of an intraocular OCT probe, including the upper clamshell. FIG. 10B shows a distal view of a mechanical model of the upper housing of the body of an intraocular OCT probe, including the lower clamshell, the upper clamshell, and the cosmetic handpiece.

[0058] In various embodiments, the external surface of the handpiece has a comfortable, ergonomic design, is similar in size to existing intraocular surgical tools, and is designed to be reusable across multiple surgical cases and safely sterilized (FIGS. 11A and 11B). FIG. 11A shows a mechanical model of the external design, illustrating the transition from the handpiece to the hypotube of an intraocular OCT probe, which is a solid tube design with strain relief. FIG. 11B shows a mechanical model of the external design, illustrating the transition from the handpiece to the hypotube of an intraocular OCT probe, which is an ergonomic handle with strain relief.

[0059] A key aspect of the feasibility of this device is a GRIN lens design that achieves the desired resolution while being small enough to fit inside a 25-gauge stainless steel tube. Extensive optical modeling was performed to test and validate the optical design (Figures 12 and 13).

[0060] Figures 12 and 13 show optical modeling performed to test and validate the optical design. Figures 12A-12C show the output of optical modeling software for testing and validating the optical design of various embodiments of OCT probes. Figure 12A shows the optical modeling of the entire intraocular OCT probe. Figure 12B shows the optical modeling of the distal tip of the intraocular OCT probe, from the optical fiber (left) to the emitted light applied to the sample (right). Figure 12C shows the optical modeling of an intraocular probe including a relay lens with a stack of multiple GRIN lenses, where the GRIN lens stack includes 12.5 GRIN lenses with an outer diameter of 0.35 mm and input light in the range of 670-1550 nm.

[0061] Figure 13 shows an example of optical modeling to evaluate the spot size and field of view (FOV) of a probe including a fiber collimator, fixed / flat mirrors, microelectromechanical systems (MEMS) and mirrors, and relay lenses including a GRIN lens.

[0062] Other designs can use a relay lens and objective lens instead of the long GRIN lens, or eliminate the telecentric lens. These modified designs have also been modeled (Figures 14, 15, and 16). Figures 14A-14C show optical modeling of various needle optical designs available for OCT probes, including different spot sizes and working distances. Figure 14A shows optical modeling of a probe embodiment including a single GRIN rod lens with an outer diameter of 0.35 mm, with the locations of the proximal (handpiece), GRIN rod, eye, and distal (needle) regions indicated for reference. Figure 14B shows optical modeling of a probe embodiment including a single GRIN rod lens with a telecentric coupling lens, with the locations of the proximal (handpiece), GRIN rod, eye, and distal (needle) regions indicated for reference. Figure 14C shows optical modeling of an embodiment of the probe using a design including a combination of relay GRIN lenses and objective GRIN lenses, with the locations of the proximal (handpiece), GRIN relay, GRIN objective, eye, and distal (needle) regions shown for reference.

[0063] 15A and 15B show the results of optical modeling of proximal optics with and without a telecentric lens. Fig. 15A shows optical modeling of the proximal optics with a single GRIN rod lens of Fig. 14A, with the positions of the fiber collimator, MEMS imaging system, prism, and GRIN rod lens shown for reference. Fig. 15B shows optical modeling of an embodiment of the proximal optics with a single GRIN rod lens with a telecentric coupling lens of Fig. 14B, with the positions of the fiber collimator, MEMS imaging system, prism, and GRIN rod lens shown for reference, with the telecentric lens having a depth of focus of 4 mm.

[0064] Figure 16 shows optical modeling of an intraocular OCT system with a single relay lens and multiple stacked GRIN lenses, including various spot sizes. The GRIN lens stack includes 12.5 GRIN lenses with an outer diameter of 0.35 mm, and input light ranging from 670 to 1550 nm. The lower left insert shows a series of through-focus spots at different focal levels offset from the central axis (top row) or on the axis (bottom row). The upper right insert shows a central in-focus spot (0 mm depth) and in-focus spots offset to either side of the central optical axis, whose deflection is due to changes in the angle of a movable reflector (e.g., a MEMS mirror). In this particular optical modeling example, the GRIN rod length can be 22–24 mm, the spot RMS radius can be 20–25 mm, the working distance can be 5 mm, the depth of focus can be approximately 2 mm, and the field of view is 1 mm.

[0065] Figure 17A shows data for tolerance analysis of each device component of the disclosed intraocular OCT probe, including the GRIN lens, fiber collimator, relay lens, and telecentric lens, including surface values, nominal values, minimum and maximum shifts, and comments to ensure manufacturability. Figure 17B shows further tolerability analysis results for each device part of the disclosed intraocular OCT probe, including "worst offender" type, baseline and variance values, and nominal, best, worst, mean, and standard deviation values, which also help ensure manufacturability.

[0066] Figure 18 shows data on throughput and back-reflection analysis of the intraocular OCT probe, indicating a total one-way transmittance of approximately 85%. The optical design was optimized to improve throughput and coupling efficiency for the wavelength range used by the swept source. These modified designs were also modeled (Figures 14, 15, and 16). Additionally, the GRIN lens was angle-polished and tilted to minimize back-reflection coupling. These optimizations are important for improving the signal-to-noise ratio and obtaining clean OCT images.

[0067] Figures 19A-19C and 20 show mechanical models of various embodiments of probes with different actuator and optical designs, generated to demonstrate feasibility. Figures 19A-19C show mechanical illustrations of the overall intraocular OCT device design using a MEMS scanning system (Figure 19A), a single fiber actuator (Figure 19B), and a rotary motor or galvanometer scanner system (Figure 19C). Figure 19A shows a mechanical illustration of the intraocular OCT device design using a MEMS scanning system, including a strain relief, proximal cap, holder, fiber collimator, prism, MEMS mount, and disposable section. Figure 19B shows a mechanical illustration of the intraocular OCT device design using a single fiber actuator, including tubing, strain relief, distal cap, actuator wire, fiber holder, fiber coating, handpiece, amplification actuator, actuator holder, fiber, cap, epoxy, 25-gauge tubing, and optics. The actuator expands and contracts to move the fiber. This adjusts the position where the laser beam enters the distal GRIN optics, scanning the beam at the desired angle. Figure 19C shows a mechanical illustration of the intraocular OCT device design using a rotational motor or galvanometer scanner system including strain relief, distal cap, holder, collimator, microstage, prism, prism holder, cap, GRIN lens stack or custom relay, and 25 gauge tubing.

[0068] Figure 20A shows a mechanical illustration of an embodiment of an intraocular OCT device housing an intraocular OCT probe with a modified handpiece design such that the rotary motor 66 extends beyond the surface of the housing, and the probe includes a strain relief 40, a proximal cap 42, a fiber collimator 44 attached to the body of the OCT probe, a fixed reflector / prism 48, a movable reflector / MEMS mirror 46, a distal cap, and a relay lens disposed in a 25 gauge tube / hypotube. Figure 20B shows a mechanical illustration of the intraocular OCT device of Figure 20A with the distal cap and hypotube / relay lens removed from the body of the probe.

[0069] Additionally, beyond the current design, there are various modifications that can be made based on the desired surgical application. In one embodiment, the intraocular OCT probe is configured to reflect the laser beam at an angle using one or more angled polished GRIN lenses or prisms in the relay lens, and curved or angled probes may be suitable for imaging the peripheral retina. Figure 21 shows a demonstration of a curved or angled probe design that may be used for imaging the peripheral retina, including an OCT probe.

[0070] In some embodiments, an intraocular OCT probe is configured to perform both white light imaging and OCT imaging through the same probe. This may be achieved by adding a splitter to the proximal end of the probe (e.g., proximal to the strain relief) to connect an optical fiber to both a white light source and a laser light source. Figure 22 shows a diagram of a probe design for simultaneously performing both white light and OCT imaging in the top panel, and the white light and infrared / OCT images in the bottom panel. Output images may be presented by projecting both the white light and OCT images onto a monitor in a split-screen / side-by-side display.

[0071] 23A-23C illustrate various embodiments of functions that may be performed in conjunction with OCT imaging using an intraocular probe. FIG. 23A illustrates a multi-channel intraocular OCT probe design with an OCT lens or fiber in the central passageway and one or more outer passageways through which one or more of suction, air, infusate, or medications are applied. FIG. 23B illustrates a multi-channel intraocular OCT probe design with an OCT lens or fiber in the central passageway and biopsy or cutting blades located in one or more outer passageways, which may be concentric with the OCT probe. FIG. 23C illustrates a multi-channel intraocular OCT probe design with partitions between passageways, where one passageway contains an OCT lens or fiber and the second passageway can be used as a working port. Among other functions, the working port may be used to perform suction or infusion during a procedure.

[0072] Compared to conventional intraocular OCT devices, the disclosed intraocular OCT probe offers certain advantages. In some embodiments, these design aspects enable the device to be manufactured on a large scale and adopted more widely. Previous intraocular OCT devices were based on the availability of a single-mode fiber at the needle tip, which posed risks to long-term durability and image stability. The disclosed design, on the other hand, uses a fiber collimator located in the handpiece rather than the needle, improving image quality and durability. Compared to single-mode fiber designs, the disclosed collimator-based design is easier to manufacture, more durable, and capable of incorporating a disposable tip. A removable / disposable tip is important for clinical feasibility from the standpoint of contamination and infection, as well as the fact that miniature optics are more likely to be damaged if used multiple times. Furthermore, the actuators in the disclosed device are much less complex than conventional actuator designs and can be purchased off-the-shelf without the need for custom, complex machining. Overall, the disclosed design is more cost-effective, more clinically feasible, and has a high potential for scaling up into a device that can be used domestically and internationally in vitreoretinal surgery and potentially other ophthalmic surgical fields. Overall, there are numerous embodiments that have been considered in the design and iterations listed above and shown in the figures.

[0073] OCT continues to be an important technology in the field of ophthalmology, with further technological advancements and machine learning-based applications impacting our understanding of ophthalmic diseases and improving patient outcomes. The disclosed intraocular OCT device enables further advancements in the field of intraoperative OCT for vitreoretinal and other ophthalmic surgeries.

[0074] Thus, while the present invention has been described above with reference to particular embodiments and examples, the present invention is not necessarily limited thereto, and numerous other embodiments, examples, uses, modifications, and departures from the embodiments, examples, and uses are intended to be encompassed by the appended claims.

Claims

1. an optical fiber coupled to a movable actuator configured to direct light emitted from the optical fiber at a plurality of varying angles; a relay lens distal to the movable actuator; It is equipped with The relay lens is configured to receive light emitted from the optical fiber and transmit the received light to a sample. An optical probe characterized by:

2. a fiber collimator disposed at a distal end of the optical fiber; a fixed reflective surface disposed distal to the fiber collimator; an adjustable reflective surface coupled to the movable actuator and positioned adjacent to the fixed reflective surface; It also has the adjustable reflective surface is configured to reflect light emitted from the fiber collimator and reflected at the fixed reflective surface at the plurality of varying angles; the relay lens is configured to receive light reflected from the adjustable reflective surface and transmit the received light to the sample. The optical probe of claim 1 .

3. the movable actuator comprises at least one of a microelectromechanical system (MEMS) device, a galvanometer, or a rotary motor; The optical probe according to claim 2 .

4. the relay lens is disposed within the distal cap; the distal cap and the relay lens are removable from the optical probe; 4. The optical probe according to claim 1.

5. the relay lens includes an objective lens at a distal end of the relay lens; 5. The optical probe according to claim 1.

6. The relay lens includes a GRIN lens. The optical probe of claim 1 .

7. The GRIN lens includes a plurality of stacked GRIN lenses. The optical probe according to claim 6.

8. the relay lens is a curved or angled probe; the relay lens comprises at least one of a prism or an angle-polished GRIN lens configured to transmit light through the curved or angled probe; The optical probe of claim 7.

9. further comprising a telecentric lens disposed between the movable actuator and the relay lens; the telecentric lens is configured to focus light emitted from the optical fiber onto the proximal end of the relay lens.

9. An optical probe according to any one of claims 1 to 8.

10. the movable actuator rotates on a first axis to scan the received light across the surface of the sample in a first direction; 10. An optical probe according to any one of claims 1 to 9.

11. the movable actuator rotates on a second axis perpendicular to the first axis to scan the received light across the surface of the sample in a second direction perpendicular to the first direction. The optical probe of claim 10.

12. the fixed reflective surface includes at least one of a mirror or a prism; The optical probe according to claim 2 .

13. the optical fiber and the movable actuator are disposed within a handpiece. The optical probe of claim 1 .

14. the handpiece includes a lower portion and an upper portion; the optical fiber and the movable actuator are located in the lower portion of the handpiece to facilitate optical alignment; the upper portion of the handpiece is secured to the lower portion of the handpiece; The optical probe of claim 13.

15. the handpiece further comprises a plurality of adjustment mechanisms provided for at least one of the optical fiber and the movable actuator; the plurality of adjustment mechanisms are configured to facilitate the optical alignment; The optical probe of claim 14.

16. The handpiece is disposed within an outer housing.

16. The optical probe of claim 15.

17. the fiber collimator, the fixed reflecting surface, the movable actuator, and the adjustable reflecting surface are disposed within one handpiece; The optical probe according to claim 2 .

18. the handpiece includes a lower portion and an upper portion; the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface are located in the lower portion of the handpiece to facilitate optical alignment; the upper portion of the handpiece is secured to the lower portion of the handpiece; 18. The optical probe of claim 17.

19. the handpiece further comprises a plurality of adjustment mechanisms for at least one of the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface; the plurality of adjustment mechanisms are configured to facilitate the optical alignment; 19. The optical probe of claim 18.

20. The handpiece is disposed within an outer housing.

20. The optical probe of claim 19.

21. the plurality of varying angles includes angles of up to 3.75 degrees on either side of the optical axis; 21. An optical probe according to any one of claims 1 to 20.

22. the relay lens is disposed within a hypotube.

22. An optical probe according to any one of claims 1 to 21.

23. the hypotube having a plurality of passages; the relay lens is disposed in a first of the plurality of passages; 23. The optical probe of claim 22.

24. the plurality of passages includes at least two passages separated by a partition; 24. The optical probe of claim 23.

25. the plurality of passages includes a plurality of concentric passages; the relay lens is disposed within the first central passage; 24. The optical probe of claim 23.

26. the second external passageway comprises at least one of a cutting blade, a suction port, an air delivery port, a fluid delivery port, or a drug delivery port; 26. The optical probe of claim 25.

27. further comprising an OCT (optical coherence tomography) system coupled to the optical fiber.

27. An optical probe according to any one of claims 1 to 26.

28. the OCT system includes an OCT light source coupled to the optical fiber.

28. The optical probe of claim 27.

29. further comprising a white light source coupled to the optical fiber.

29. The optical probe of claim 28.

30. the sample comprises a retina, 30. An optical probe according to any one of claims 1 to 29.

31. 1. A method of operating an optical probe, comprising: Providing an optical fiber coupled to a movable actuator; directing light emitted from said optical fiber at a plurality of varying angles; receiving light emitted from the optical fiber by a relay lens distal to the movable actuator; transmitting the received light to a sample; A method comprising:

32. a fiber collimator disposed at a distal end of the optical fiber; a fixed reflective surface disposed distal to the fiber collimator; an adjustable reflective surface coupled to the movable actuator and positioned adjacent to the fixed reflective surface; To prepare the following: using the adjustable reflective surface to reflect the light emitted from the fiber collimator and reflected by the fixed reflective surface at the plurality of varying angles; receiving light reflected from the adjustable reflective surface by the relay lens; transmitting the received light to the sample by the relay lens; 32. The method of claim 31, further comprising:

33. the movable actuator comprises at least one of a microelectromechanical system (MEMS) device, a galvanometer, or a rotary motor; 33. The method of claim 32.

34. the relay lens is disposed within the distal cap; The method comprises: Removing the distal cap and the relay lens from the optical probe.

34. The method of any one of claims 31 to 33, further comprising:

35. the relay lens includes an objective lens at a distal end of the relay lens; 35. The method of any one of claims 31 to 34.

36. The relay lens includes a GRIN lens.

32. The method of claim 31.

37. The GRIN lens includes a plurality of stacked GRIN lenses.

37. The method of claim 36.

38. the relay lens is a curved or angled probe; the relay lens comprises at least one of an angle-polished GRIN lens or a prism; The method comprises: directing light through said curved or angled probe with said at least one of an angle-polished GRIN lens or a prism; 38. The method of claim 37, further comprising:

39. further comprising a telecentric lens disposed between the movable actuator and the relay lens; The method comprises: using the telecentric lens to focus light emitted from the optical fiber onto the proximal end of the relay lens.

39. The method of any one of claims 31 to 38, further comprising:

40. and rotating the movable actuator on a first axis to scan the received light across the surface of the sample in a first direction.

40. The method of any one of claims 31 to 39.

41. and rotating the movable actuator on a second axis perpendicular to the first axis to scan the received light across the surface of the sample in a second direction perpendicular to the first direction.

41. The method of claim 40.

42. the fixed reflective surface includes at least one of a mirror or a prism; 33. The method of claim 32.

43. the optical fiber and the movable actuator are disposed within a handpiece.

32. The method of claim 31.

44. the handpiece includes a lower portion and an upper portion; The method comprises: disposing the optical fiber and the movable actuator in the lower portion of the handpiece to facilitate optical alignment; securing the upper portion of the handpiece to the lower portion of the handpiece; 44. The method of claim 43, further comprising:

45. the handpiece further comprises a plurality of adjustment mechanisms provided for at least one of the optical fiber and the movable actuator; performing the optical alignment using the plurality of adjustment mechanisms; 45. The method of claim 44.

46. further comprising disposing the handpiece within an outer housing.

46. ​​The method of claim 45.

47. further comprising disposing the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface within one handpiece.

33. The method of claim 32.

48. the handpiece includes a lower portion and an upper portion; The method comprises: disposing the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface in the lower portion of the handpiece to facilitate optical alignment; securing the upper portion of the handpiece to the lower portion of the handpiece; 48. The method of claim 47, further comprising:

49. the handpiece further comprises a plurality of adjustment mechanisms for at least one of the fiber collimator, the fixed reflective surface, the movable actuator, and the adjustable reflective surface; The method comprises: performing the optical alignment using the plurality of adjustment mechanisms; 49. The method of claim 48, further comprising:

50. further comprising disposing the handpiece within an outer housing.

50. The method of claim 49.

51. Directing the light emitted from the optical fiber at a plurality of varying angles comprises: directing the light emitted from said optical fiber at a plurality of varying angles, including angles of up to 3.75 degrees on either side of the optical axis; 51. The method of any one of claims 31 to 50, further comprising:

52. further comprising disposing the relay lens within a hypotube.

52. The method of any one of claims 31 to 51.

53. the hypotube having a plurality of passages; The method comprises: disposing the relay lens in a first one of the plurality of passages; 53. The method of claim 52, further comprising:

54. the plurality of passages includes at least two passages separated by a partition; 54. The method of claim 53.

55. the plurality of passages includes a plurality of concentric passages; The method comprises: disposing the relay lens within the first central passage; 54. The method of claim 53, further comprising:

56. the second external passageway comprises at least one of a cutting blade, a suction port, an air delivery port, a fluid delivery port, or a drug delivery port; 56. The method of claim 55.

57. further comprising an OCT (optical coherence tomography) system coupled to the optical fiber.

57. The method of any one of claims 31 to 56.

58. the OCT system includes an OCT light source coupled to the optical fiber.

58. The method of claim 57.

59. further comprising coupling a white light source into the optical fiber.

59. The method of claim 58.

60. the sample comprises a retina, 60. The method of any one of claims 31 to 59.

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