Method and system for oct guide glaucoma surgery

Abstract

To provide improved method and device for determining a target position of an opening leading to Schlemm's canal through trabecular meshwork, and improving the flow.SOLUTION: A surgical procedure includes the insertion of a slender probe 23 into a target tissue area including trabecular meshwork 9 and Schlemm's canal from an opening to the inside of the eye across the anterior chamber. An exemplary system includes: an optical microscope for a surgeon to visually recognize the eye by a microscopic image during the procedure; an optical coherence tomographic (OCT) device configured to perform OCT scanning of a target position in the target tissue area during the procedure; and an image processing device configured to generate an expansion image by superimposing an OCT image of the target position and a graphic visual element for identifying the position. The graphic visual element is aligned with the microscopic image for helping the surgeon advance the distal end of the slender probe to the target position.SELECTED DRAWING: Figure 6

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 521,310, filed Jun. 16, 2017, entitled "Methods and Systems for OCT Guided Glaucoma Surgery". This application is also related to U.S. Patent Application No. 15 / 868,904, filed Jan. 11, 2018, entitled "Methods and Systems for OCT Guided Glaucoma Surgery". Each of these applications is hereby incorporated by reference in its entirety.

Background Art

[0002] Glaucoma is a disease of the eye in which intraocular structures important for vision are irreversibly damaged. These structures include parts of the retina, particularly parts of the optic nerve. Treatable glaucoma is listed as the second leading cause of blindness in the United States. Millions of people are affected. There are two main types of glaucoma: open - angle glaucoma and closed - angle glaucoma. Open - angle glaucoma, the most common type of glaucoma, occurs when the normally visible outflow pathway malfunctions, and as a result, the eye fails to drain fluid properly, causing intraocular pressure to rise. The intraocular pressure (IOP) increase in most open - angle glaucoma cases is mainly due to the obstruction of aqueous humor outflow located mainly in the trabecular meshwork (TM) and the inner wall of Schlemm's canal (SC).

[0003] Treatment methods for IOP elevation due to outflow obstruction include topical and systemic medications, laser surgery by general practitioners, and invasive surgeries with inherent risks (fibrous trabecular ablation / tube shunt). Examples of laser surgery include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Recently, minimally invasive glaucoma surgery (MIGS), or minimally invasive glaucoma surgery, a minimally invasive surgery generally called, has been introduced into the treatment paradigm. The current approach to IOP reduction by MIGS includes increasing trabecular outflow by bypassing the trabecular meshwork (TM) and the inner wall of the SC, increasing uveoscleral outflow via the choroidal pathway, decreasing aqueous humor production from the ciliary body, or creating an external subconjunctival / sub-scleral drainage pathway.

[0004] The general concept of MIGS is usually not to create alternative pathways that may have significantly high short-term and / or long-term risks, but rather to bypass the outflow obstruction and often enable the resumption of flow through the eye's native outflow system that functions intact beyond the area of outflow obstruction.

[0005] MIGS procedures often involve visualization and access to the intraocular outflow system. Due to the shape of the cornea and the position of the intraocular structures related to MIGS procedures in the area where the iris is thought to be in contact with the peripheral cornea, internal total reflection occurs, which may prevent the surgeon from visualizing the outflow structures that exist beyond the "critical angle" of the optical path. The critical angle can also be referred to as the "critical angle" of the anterior chamber optical visualization path in the context of anterior chamber surgical procedures disclosed herein. According to some embodiments, the optical paths disclosed herein can refer to visualizing the anterior chamber angle structures and do not refer to the optical path of the eye's visual system, e.g., from near the center of the cornea to the macula. Therefore, in order for a surgeon to perform MIGS procedures, a device that enables visualization of these outflow structures is often required. Gonioscopic lenses function both directly (enabling a straight optical path for visualizing these structures) and indirectly (using a mirror to visualize these structures) by overcoming internal total reflection. However, the intraoperative use of gonioscopic lenses may require considerable dexterity and a steep learning curve, which may, in at least some cases, limit successful MIGS procedures to certain skilled surgeons.

[0006] In at least some of these surgical procedures, a surgical opening can be created through the trabecular meshwork and the inner wall of the Schlemm's canal to allow for improved fluid access to the Schlemm's canal to reduce intraocular pressure. Conventional approaches that precisely target the Schlemm's canal are often not ideal. Thus, it would be beneficial to provide methods and devices for improving consistency and accuracy in targeting the Schlemm's canal and other structures of the eye. Also, research related to the present disclosure suggests that at least some of the conventional approaches may result in an opening in the Schlemm's canal at a location different from the ideal location, such as a location far from the collecting channels. Alternative MIGS devices that bypass the Schlemm's canal and drain aqueous humor into the suprachoroidal space can also benefit from improved visualization of adjacent intraocular structures. Examples of such implant devices include the iStent® in the canaliculus, iStent Inject, and the CyPass® Micro-Stent in the suprachoroid. Excimer laser trabeculotomy (ELT), which creates a channel opening that communicates with the Schlemm's canal, can also benefit from improved targeting and visualization of the eye's structures.

[0007] Current methods and devices for visualizing eye structures near the iridocorneal angle, such as the trabecular meshwork and scleral spur, may not be ideal in at least some cases. For example, gonioscopy lenses can be somewhat more difficult to use than ideal, and it would be beneficial to provide an improved method for visualizing eye structures near the iridocorneal angle during surgery in this area.

[0008] In light of the above, improved methods and devices for imaging the eye during a surgical procedure, targeting an eye outflow structure such as the Schlemm's canal, and determining a target location for an opening that communicates through the trabecular meshwork to the Schlemm's canal to improve flow would be useful. SUMMARY OF THE INVENTION

[0009] The methods and devices disclosed herein enable glaucoma surgery on outflow structures, including MIGS and many of its types, to be performed without goniosynechiae. According to one aspect of the invention, an eye surgeon can identify these outflow structures and operate on these structures through virtual images and displays of the structures and surgical instruments generated using optical coherence tomography (OCT) scans.

[0010] In one aspect, a system is provided that assists a physician in performing a surgical procedure on an eye. The surgical procedure includes inserting an elongated probe through an opening into the eye across the anterior chamber to a target tissue region including the trabecular meshwork and Schlemm's canal. The system includes an optical microscope for the surgeon to visually inspect the eye with a microscopic image during the procedure, one or more OCT devices configured to perform optical coherence tomography (OCT) scans of one or more target positions in the target tissue region in real time during the procedure, and an image processing device configured to generate a plurality of augmented images (real and virtual) by enabling viewing of (1) one or more OCT images of one or more target positions and / or (2) a plurality of graphic visual elements identifying one or more target positions, and in some cases, superimposing them thereon, wherein the plurality of graphic visual elements are aligned with the actual microscopic image to assist the physician in advancing the distal end of the elongated probe to one or more target positions.

[0011] In another aspect, embodiments of the present invention include a method of performing a surgical procedure on a patient's eye. An exemplary method may include viewing a real-time view on a viewing device, the real-time view may include (i) a microscopic view of the eye, and (ii) an extended image having the microscopic view or a microscopic image of the eye. The extended image may also have an optical coherence tomography (OCT) image of the target tissue region. The OCT image may be aligned with the microscopic view or the microscopic image. The OCT image can enable identification of a target position located in the target tissue, and the actual target position is not visible by eye within the microscopic view or the microscopic image. An exemplary method is to advance the distal end of an elongated probe in the anterior chamber of the eye toward the target tissue region while viewing the microscopic view or the extended image of the viewing device, the distal end of the elongated probe being first visible within the microscopic view or the microscopic image, and then, due to total internal reflection within the region of the eye where the target tissue is located, becoming not visible within the microscopic view or the microscopic image. The exemplary method may further include performing a surgical procedure at the actual target position using the elongated probe while the distal end of the elongated probe is not visible within the microscopic view or the microscopic image and while perceiving information from the extended image regarding the relative position of the distal end of the elongated probe with respect to the target position.

[0012] According to some embodiments, the graphic visual element for identifying the target position can be superimposed on the microscope view or microscope image. In some embodiments, the real-time view includes an augmented image with a microscope view of the eye, the OCT image is aligned with the microscope view, and the actual target position is not visible within the microscope view. The graphic visual element may be superimposed on the microscope view. In some embodiments, the step of advancing comprises advancing the distal end of the elongated probe in the anterior chamber of the eye towards the target tissue region while viewing the augmented image on the viewing device, wherein the distal end of the elongated probe is first visible within the microscope view and then becomes not visible within the microscope view due to total internal reflection within the region of the eye where the target tissue region is located. In some embodiments, the step of performing comprises performing a surgical procedure at the actual target position using the elongated probe while the distal end of the elongated probe is not visible within the microscope view and while perceiving information from the microscope view regarding the relative position of the distal end of the elongated probe with respect to the target position. In some embodiments, the real-time view includes an augmented image and the OCT image aligned with the microscope view or microscope image includes information regarding the Schlemm's canal and the collector channel system. In some embodiments, the real-time view includes an augmented image and the OCT image aligned with the microscope view or microscope image includes information regarding the relative position of the distal end of the elongated probe with respect to the target position.

[0013] In some examples, the graphic visual element corresponding to the distal end of the elongated probe is overlaid on the microscope view or microscope image, and the step of advancing includes advancing the distal end of the elongated probe toward the target tissue region while visually recognizing the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the target position on the magnified image. In some embodiments, the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork of the eye are overlaid on the microscope view or microscope image, and the method includes determining that there is contact between the distal end of the elongated probe and the surface of the trabecular meshwork when the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork are sufficiently close. In some embodiments, the graphic visual element corresponding to the surface of the trabecular meshwork of the eye and the graphic visual element corresponding to the juxtacanalicular trabecular meshwork are overlaid on the microscope view or microscope image, and the method includes determining whether the trabecular meshwork of the eye is sufficiently compressed when the graphic visual element corresponding to the surface of the trabecular meshwork and the graphic visual element corresponding to the juxtacanalicular trabecular fiber meshwork are sufficiently close. In some embodiments, the graphic visual element corresponding to the inner wall of the Schlemm's canal of the eye is overlaid on the microscope view or microscope image, and the method includes determining that the inner wall of the Schlemm's canal has been penetrated when the graphic visual element corresponding to the inner wall of the Schlemm's canal disappears from the microscope view or microscope image.

[0014] In some examples, the guidance arrow is overlaid on the microscope view or microscope image, and the guidance arrow points to a graphic visual element that identifies the target location. In some examples, the guidance arrow is overlaid on the microscope view or microscope image, and the guidance arrow points to a graphic visual element that identifies the target location. In some methods, the step of advancing includes advancing the distal end of the elongate probe toward the target location while using the guidance arrow as a guide. In some methods, the step of performing includes ablating the target location with a laser pulse emitted from the elongate probe, following creation of a channel that connects the anterior chamber to the lumen of Schlemm's canal at the target location, a second guidance arrow is overlaid on the microscope view of the microscope image, the second guidance arrow points to a second graphic visual element that identifies a second target location of the eye, and the method may further include advancing the distal end of the elongate probe toward the second target location while using the second guidance arrow as a guide. The method may also include ablating the second target location with the elongate probe.

[0015] In some embodiments, it can be a display device, a microscope device, a head-up display, a visual monitor, a virtual reality visual device, or an augmented reality visual device. In some embodiments, the graphic visual element that identifies the distal end of the elongated probe can be superimposed on the microscope view or microscope image, and the relative position of the distal end of the elongated probe with respect to the target position can be based on the relative position of the elongated probe with respect to the graphic visual element that identifies the target position. In some examples, the actual target position is not visible within the microscope view or microscope image due to total internal reflection within the eye. In some examples, the target position is determined based on a preoperative optical coherence tomography (OCT) image, an intraoperative optical coherence tomography (OCT) image, a preoperative optical coherence tomography (OCT) image and an intraoperative optical coherence tomography (OCT) image, or a determination by the surgeon. In some examples, the preoperative OCT image shows the trabecular meshwork of the eye's Schlemm's canal and collecting channels, and the target position is determined based on the preoperative OCT image. In some examples, the target position is determined based on a microscope-based OCT image, a fiber-optic-based OCT image, or a microscope-based OCT image and a fiber-optic-based OCT image.

[0016] In yet another aspect, embodiments of the present invention include a method of assisting a surgeon in performing a surgical procedure on a patient's eye. In such a procedure, the surgeon may use an elongated probe having a distal end. An exemplary method includes providing a real-time view to the surgeon. The real-time view may include (i) a microscope view of the eye, and (ii) an augmented image having the microscope view or a microscope image of the eye. The augmented image may further include an optical coherence tomography (OCT) image of the target tissue region. The OCT image may be aligned with the microscope view or microscope image. The OCT image may enable identification of a target position located in the target tissue region. The actual target position may not be visible within the microscope view or microscope image. The augmented image may enable the surgeon to perceive information regarding the relative position of the distal end of the elongated probe with respect to the target position when the distal end of the elongated probe is not visible within the microscope view or microscope image.

[0017] In some examples, the graphic visual element that identifies the target location may be overlaid on the microscope view or microscope image. In some examples, the real-time view includes an extended image with a microscope view of the eye, the OCT image is aligned with the microscope view, the actual target location is not visible in the microscope view, and the extended image enables the surgeon to perceive information regarding the relative position of the distal end of the elongate probe with respect to the target location when the distal end of the elongate probe is not visible in the microscope view. The graphic visual element may be overlaid on the microscope view. According to some embodiments, the real-time view includes an extended image with a microscope image of the eye, the OCT image is aligned with the microscope image, the actual target location is not visible in the microscope image, and the extended image enables the surgeon to perceive information regarding the relative position of the distal end of the elongate probe with respect to the target location when the distal end of the elongate probe is not visible in the microscope image. The graphic visual element may be overlaid on the microscope image.

[0018] According to some embodiments, the real-time view includes an enhanced image, and the OCT image aligned with the microscopic view or microscopic image includes information regarding the Schlemm's canal and the collecting channel system. According to some embodiments, the real-time view includes an enhanced image, and the OCT image aligned with the microscopic view or microscopic image includes information regarding the relative position of the distal end of the elongated probe with respect to the target position. In some examples, the graphic visual element corresponding to the distal end of the elongated probe is superimposed on the microscopic view or microscopic image, and the information regarding the relative position of the distal end of the elongated probe with respect to the target position is provided by the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the target position. In some examples, the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork of the eye are superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine that there is contact between the distal end of the elongated probe and the surface of the trabecular meshwork based on the relative position between the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork. In some examples, the graphic visual element corresponding to the surface of the trabecular meshwork and the graphic visual element corresponding to the juxtacanalicular trabecular meshwork of the eye are superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine whether the trabecular meshwork of the eye is sufficiently compressed based on the relative position between the graphic visual element corresponding to the surface of the trabecular meshwork and the graphic visual element corresponding to the juxtacanalicular trabecular meshwork. In some examples, the graphic visual element corresponding to the inner wall of the Schlemm's canal of the eye is superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine whether the inner wall of the Schlemm's canal has been penetrated based on whether the graphic visual element corresponding to the inner wall of the Schlemm's canal is present or absent in the microscopic view or microscopic image.

[0019] According to some embodiments, the guidance arrow is overlaid on the microscope view or microscope image, and the guidance arrow points to a graphic visual element that identifies the target position. According to some embodiments, the guidance arrow is overlaid on the microscope view or microscope image, and the guidance arrow points to a graphic visual element that identifies the target position. Following ablation of the target position, a second guidance arrow is overlaid on the microscope view of the microscope image, and the second guidance arrow points to a second graphic visual element that identifies a second target position of the eye. In some examples, the real-time view is provided to the surgeon by a display device, a microscope device, a head-up display, a visual recognition monitor, a virtual reality visual recognition device, or an augmented reality visual recognition device. In some examples, a graphic visual element that identifies the distal end of the elongate probe is overlaid on the microscope view or microscope image, and the relative position of the distal end of the elongate probe with respect to the target position is based on the relative position of the distal end of the elongate probe that identifies the distal end of the elongate probe with respect to the graphic visual element that identifies the target position. In some examples, the actual target position is not visible within the microscope view or microscope image due to total internal reflection of the eye. In some examples, the target position is determined based on a preoperative optical coherence tomography (OCT) image, an intraoperative optical coherence tomography (OCT) image, a preoperative optical coherence tomography (OCT) image and an intraoperative optical coherence tomography (OCT) image, or a determination by the surgeon. In some examples, the preoperative OCT image shows the mesh of the Schlemm's canal and the collecting channels of the eye, and the target position is determined based on the preoperative OCT image.

[0020] According to some embodiments, the target position can be determined based on a microscope-based OCT image, a fiber-optic-based OCT image, or both a microscope-based OCT image and a fiber-optic-based OCT image. In some examples, the method may further include providing a notification to the surgeon upon detection of sufficient compression of the trabecular meshwork of the eye, wherein the sufficient compression is detected based on the relative position of a graphic visual element corresponding to the surface of the trabecular meshwork and a graphic visual element corresponding to the juxtacanalicular trabecular meshwork. In some examples, the method may also include automatically initiating delivery of laser ablation energy to the actual target position upon detection of sufficient compression of the trabecular meshwork of the eye. In some cases, it may include providing a notification to the surgeon upon detection of penetration of the inner wall of the Schlemm's canal, wherein the penetration of the inner wall of the Schlemm's canal is detected by an elongated probe and is indicated in a real-time view based on whether a graphic visual element corresponding to the inner wall of the Schlemm's canal is present or absent in the magnified image. In some cases, the method may include automatically terminating delivery of laser ablation energy to the actual target position upon detection of penetration of the inner wall of the Schlemm's canal.

[0021] In another aspect, embodiments of the present invention include, for example, a computer program product that assists a surgeon in performing a surgical procedure on a patient's eye when the surgeon uses an elongated probe having a distal end. The computer program product may be embodied on a non-transitory tangible computer-readable medium. An exemplary computer program product includes computer-executable code for generating a real-time view for viewing by the surgeon, the real-time view including (i) a microscopic view of the eye, and (ii) an extended image having the microscopic view or a microscopic image of the eye. The extended image may further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image may be aligned with the microscopic view or the microscopic image. The OCT image may enable identification of a target position located in the target tissue region. The actual target position may not be visible within the microscopic view or the microscopic image. The extended image may enable the surgeon to perceive information regarding the relative position of the distal end of the elongated probe with respect to the target position when the distal end of the elongated probe is not visible within the microscopic view or the microscopic image. In some cases, a graphic visual element that identifies the target position located in the target tissue region is superimposed on the microscopic view or the microscopic image. According to some embodiments, the real-time view includes an extended image having a microscopic view of the eye, the OCT image is aligned with the microscopic view, the actual target position is not visible within the microscopic view, and the extended image enables the surgeon to perceive information regarding the relative position of the distal end of the elongated probe with respect to the target position when the distal end of the elongated probe is not visible within the microscopic view. The graphic visual element may be superimposed on the microscopic view. According to some embodiments, the real-time view includes an extended image having a microscopic image of the eye, the OCT image is aligned with the microscopic image, the actual target position is not visible within the microscopic image, and the extended image enables the surgeon to perceive information regarding the relative position of the distal end of the elongated probe with respect to the target position when the distal end of the elongated probe is not visible within the microscopic image. The graphic visual element may be superimposed on the microscopic image.

[0022] In some examples, the real-time view includes an enhanced image, and the OCT image aligned with the microscopic view or microscopic image includes information regarding the Schlemm's canal and the collecting channel system. In some examples, the real-time view includes an enhanced image, and the OCT image aligned with the microscopic view or microscopic image includes information regarding the relative position of the distal end of the elongated probe with respect to the target location. In some examples, the graphic visual element corresponding to the distal end of the elongated probe is superimposed on the microscopic view or microscopic image, and the information regarding the relative position of the distal end of the elongated probe with respect to the target location is provided by the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the target location. In some examples, the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork of the eye are superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine that there is contact between the distal end of the elongated probe and the surface of the trabecular meshwork based on the relative position between the graphic visual element corresponding to the distal end of the elongated probe and the graphic visual element corresponding to the surface of the trabecular meshwork. In some examples, the graphic visual element corresponding to the surface of the trabecular meshwork and the graphic visual element corresponding to the juxtacanalicular trabecular meshwork of the eye are superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine whether the trabecular meshwork of the eye is sufficiently compressed based on the relative position between the graphic visual element corresponding to the surface of the trabecular meshwork and the graphic visual element corresponding to the juxtacanalicular trabecular meshwork. In some examples, the graphic visual element corresponding to the inner wall of the Schlemm's canal of the eye is superimposed on the microscopic view or microscopic image, and the enhanced image enables the surgeon to determine whether the inner wall of the Schlemm's canal has been penetrated based on whether the graphic visual element corresponding to the inner wall of the Schlemm's canal is present or absent in the microscopic view or microscopic image.

[0023] According to some embodiments, a guidance arrow may be overlaid on a microscope view or a microscope image, and the guidance arrow may point to a graphic visual element that identifies a target position. In some embodiments, a guidance arrow may be overlaid on a microscope view or a microscope image, and the guidance arrow may point to a graphic visual element that identifies a target position. Following ablation of the target position, a second guidance arrow may be overlaid on the microscope view of the microscope image, and the second guidance arrow may point to a second graphic visual element that identifies a second target position of the eye. In some examples, a real-time view may be provided to the surgeon by a display device, a microscope device, a head-up display, a visual recognition monitor, a virtual reality visual recognition device, or an augmented reality visual recognition device. In some examples, a graphic visual element that identifies the distal end of an elongate probe may be overlaid on a microscope view or a microscope image, and the relative position of the distal end of the elongate probe with respect to the target position is based on the relative position of the graphic visual element that identifies the distal end of the elongate probe with respect to the graphic visual element that identifies the target position. In some cases, the actual target position may not be visible within the microscope view or microscope image due to total internal reflection within the eye.

[0024] According to some embodiments, the target position can be determined based on a preoperative optical coherence tomography (OCT) image, an intraoperative optical coherence tomography (OCT) image, or both a preoperative optical coherence tomography (OCT) image and an intraoperative optical coherence tomography (OCT) image. In some cases, the preoperative OCT image can show the trabecular meshwork and the network of collecting channels of the eye, and the target position can be determined based on the preoperative OCT image. In some cases, the target position can be determined based on a microscope-based OCT image, a fiber-optic-based OCT image, both a microscope-based OCT image and a fiber-optic-based OCT image, or a determination by a surgeon. The computer program product can further include computer-executable code for providing a notification to the surgeon upon detection of sufficient compression of the trabecular meshwork of the eye, where the sufficient compression is detected based on the relative position of a graphic visual element corresponding to the surface of the trabecular meshwork and a graphic visual element corresponding to the juxtacanalicular trabecular meshwork. In some cases, the computer program product can further include computer-executable code for automatically initiating delivery of laser ablation energy to the actual target position upon detection of sufficient compression of the trabecular meshwork of the eye. In some cases, the computer program product can further include computer-executable code for providing a notification to the surgeon upon detection of penetration of the inner wall of the Schlemm's canal, where the penetration of the inner wall of the Schlemm's canal is detected by an elongated probe and the graphic visual element corresponding to the inner wall of the Schlemm's canal is shown in a real-time view based on whether it is present or absent within the magnified image. In some cases, the computer program product can further include computer-executable code for automatically terminating delivery of laser ablation energy to the actual target position upon detection of penetration of the inner wall of the Schlemm's canal.

[0025] In another aspect, embodiments of the present invention include a method of performing a surgical procedure on a patient's eye. Exemplary methods include viewing a real-time view with a viewing device, the real-time view including a microscopic view or an augmented image having a microscopic image of the eye. The augmented image may further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image may include information regarding the Schlemm's canal and the collector channel system and may be aligned with the microscopic view or microscopic image. In some cases, a graphic visual element that identifies a target position located in the target tissue region may be overlaid on the microscopic view or microscopic image. The actual target position may not be visible within the microscopic view or microscopic image. Exemplary methods also include advancing the distal end of an elongate probe within the anterior chamber of the eye toward the target tissue region while viewing the augmented image of the viewing device, the distal end of the elongate probe being first visible within the microscopic view or microscopic image and then becoming non-visible within the microscopic view or microscopic image due to total internal reflection within the region of the eye where the target tissue is located. Exemplary methods also include performing a surgical procedure at the actual target position using the elongate probe while the distal end of the elongate probe is not visible within the microscopic view or microscopic image and while perceiving information from the augmented image regarding the relative position of the distal end of the elongate probe with respect to the target position.

[0026] In yet another aspect, embodiments of the present invention include a method of performing a surgical procedure on a patient's eye. An exemplary method includes viewing a real-time view with a viewing device, the real-time view including a microscopic view of the eye or an extended image having a microscopic image. The extended image may further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image may be aligned with the microscopic view or the microscopic image. A graphic visual element identifying a target position located in the target tissue region may be superimposed on the microscopic view or the microscopic image. The actual target position may not be visible within the microscopic view or the microscopic image. The exemplary method may also include advancing the distal end of an elongate probe within the anterior chamber of the eye toward the target tissue region while viewing the extended image on the viewing device, the distal end of the elongate probe being initially visible within the microscopic view or the microscopic image and then becoming non-visible within the microscopic view or the microscopic image due to total internal reflection within the region of the eye where the target tissue is located. The OCT image aligned with the microscopic view or the microscopic image may include information regarding the relative position of the distal end of the elongate probe with respect to the target position. The exemplary method may also include performing a surgical procedure at the actual target position using the elongate probe while the distal end of the elongate probe is not visible within the microscopic view or the microscopic image and while perceiving information regarding the relative position of the distal end of the elongate probe with respect to the target position.

[0027] In yet another aspect, embodiments of the present invention include a computer system for assisting a surgeon in performing a surgical procedure on a patient's eye. During the surgical procedure, the surgeon may use an elongated probe having a distal end. An exemplary computer system may include a processor, an electronic memory location operably coupled to the processor, and processor-executable code stored in the electronic memory location and embodied on a tangible, non-transitory computer-readable medium. When executed by the processor, the processor-executable code may cause the processor to generate a real-time view for visual inspection by the surgeon. The real-time view may include (i) a microscopic view of the eye, and (ii) an extended image having the microscopic view or a microscopic image of the eye. The extended image may further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image may be aligned with the microscopic view or the microscopic image. The actual target position may not be visible within the microscopic view or the microscopic image. The extended image may enable the surgeon to perceive information regarding the relative position of the distal end of the elongated probe with respect to the target position when the distal end of the elongated probe is not visible within the microscopic view or the microscopic image. In some cases, a graphic visual element identifying the target position located in the target tissue region may be superimposed on the microscopic view or the microscopic image.

[0028] In yet another aspect, embodiments of the present invention include a fiber-based device for performing a surgical procedure in a target tissue region disposed beyond the critical angle of a patient's eye. Exemplary fiber-based devices may include a sheath and one or more optical fibers encapsulated by the sheath. The one or more optical fibers may be configured to (i) transmit light energy sufficient to photoablate the target tissue region and (ii) enable optical coherence tomography (OCT) imaging of the eye. The fiber-based device may be configured to perform OCT imaging of the target tissue region along the longitudinal axis of the probe. In some cases, the target tissue region includes the trabecular meshwork, juxtacanalicular trabecular meshwork, inner wall of the eye's Schlemm's canal, and Schlemm's canal. In some cases, a fiber-based device configured to transmit light energy sufficient to photoablate the target tissue region when an OCT scan indicates that the trabecular meshwork of the target tissue region is sufficiently compressed. In some cases, the fiber-based device may be configured to automatically stop transmission of light energy when an OCT scan indicates that the inner wall of Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to automatically stop transmission of light energy when an OCT scan indicates that the inner wall of Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to notify the surgeon to stop transmission of light energy when an OCT scan indicates that the inner wall of Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to be detected by a microscope-based OCT device. In some cases, the fiber-based device is configured to be detected by a microscope-based OCT device, and information processed by both the fiber-based device and the microscope-based OCT device may be displayed to enable the surgeon to perform surgery within the target tissue region.

[0029] In yet another aspect, embodiments of the present invention include a microscope-based optical coherence tomography (OCT) apparatus for use in facilitating a surgical procedure in a target tissue region disposed beyond the critical angle of a patient's eye. An exemplary microscope-based OCT apparatus may include an OCT unit configured to (i) detect a probe disposed within the anterior chamber of the eye and (ii) enable OCT imaging of the eye. The microscope-based OCT is configured to perform OCT imaging of the target tissue region. In some cases, the target tissue region includes the trabecular meshwork, juxtacanalicular trabecular meshwork, inner wall of the Schlemm's canal of the eye, and the Schlemm's canal. In some cases, the microscope-based OCT apparatus is configured to detect a fiber-based device. In some cases, the fiber-based device is configured to transmit sufficient light energy to photoablate the target tissue region when a microscope-based OCT scan indicates that the trabecular meshwork of the target tissue region is sufficiently compressed. In some cases, the fiber-based device can be configured to automatically stop transmission of light energy when a microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to stop transmission of light energy when a microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to notify a surgeon to stop transmission of light energy when a microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the fiber-based device is configured to be detected by the microscope-based OCT apparatus, and information processed by both the fiber-based device and the microscope-based OCT apparatus can be displayed to enable a surgeon to perform surgery within the target tissue region.

[0030] In yet another aspect, embodiments of the present invention include a computer program product for controlling a microscope-based optical coherence tomography (OCT) device and a fiber-based device during a surgical procedure. The surgical procedure may be performed by a surgeon in a target tissue region disposed beyond the critical angle of a patient's eye. An exemplary computer program product may include computer-executable code for instructing a microscope-based OCT device to perform OCT imaging of the target tissue region and computer-executable code for instructing a fiber-based device to perform OCT imaging of the target tissue region along the longitudinal axis of a probe controlled by the surgeon. In some cases, the target tissue region includes the trabecular meshwork, juxtacanalicular trabecular meshwork, inner wall of the eye's Schlemm's canal, and Schlemm's canal. In some cases, the computer program product may further include computer-executable code for instructing the fiber-based device to transmit sufficient light energy to photoablate the target tissue region when an OCT scan performed by the fiber-based device indicates that the trabecular meshwork of the target tissue region is sufficiently compressed. In some cases, the computer program product may further include computer-executable code for instructing the microscope-based OCT device to enable the fiber-based device to transmit sufficient light energy to photoablate the target tissue region when an OCT scan performed by the microscope-based OCT device indicates that the trabecular meshwork of the target tissue region is sufficiently compressed. In some cases, the computer program product may further include computer-executable code for instructing a fiber-based device combined with a microscope-based OCT device to enable the fiber-based device to transmit sufficient light energy to photoablate the target tissue region when an OCT scan performed by the fiber-based device combined with the microscope-based OCT device indicates that the trabecular meshwork of the target tissue region is sufficiently compressed.In some cases, the computer program product may further include computer-executable code for automatically stopping the transmission of optical energy when an OCT scan performed by a fiber-based device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for automatically stopping the transmission of optical energy when an OCT scan performed by a microscope-based OCT device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for automatically stopping the transmission of optical energy when an OCT scan performed by a fiber-based device combined with a microscope-based OCT device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for notifying a surgeon to stop the transmission of optical energy when an OCT scan performed by a fiber-based device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for notifying a surgeon to stop the transmission of optical energy when an OCT scan performed by a microscope-based OCT device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for notifying a surgeon to automatically stop the transmission of optical energy when an OCT scan performed by a fiber-based device combined with a microscope-based OCT device indicates that the inner wall of the Schlemm's canal has been penetrated. In some cases, the computer program product may further include computer-executable code for instructing a microscope-based OCT device to detect a fiber-based device. In some cases, the fiber-based device may be configured to be detected by a microscope-based OCT device, and information processed by both the fiber-based device and the microscope-based OCT device may be displayed to enable a surgeon to perform surgery within a target tissue region.

[0031] In another aspect, an embodiment of the invention includes a treatment method that includes visually inspecting an augmented image on a viewing device, the augmented image having a microscopic view or microscopic image of an eye and further having an optical coherence tomography (OCT) image of a target tissue region. The OCT image may be aligned with the microscopic view or microscopic image. The OCT image may enable identification of a target location positioned in the target tissue region, and the target location may not be visible by visual inspection in the microscopic view or microscopic image. The related method may include advancing the distal end of an elongated probe within the anterior chamber of the eye toward the target tissue region while visually inspecting the microscopic view or the augmented image of the viewing device, the distal end of the elongated probe being initially visible within the microscopic view or microscopic image and then becoming non-visible within the microscopic view or microscopic image due to internal total reflection within the eye. The related method may further include performing a surgical procedure at the target location using the elongated probe while the distal end of the elongated probe is not visible within the microscopic view or microscopic image and while perceiving information from the augmented image regarding the relative position of the distal end of the elongated probe with respect to the target location.

[0032] Incorporation by reference All publications, patents, patent applications, journal articles, books, technical references, etc. mentioned herein are hereby incorporated by reference into this specification to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference were specifically and individually indicated to be incorporated by reference.

Brief Description of the Drawings

[0033] The novel features of the invention are set forth in detail in the appended claims. A better understanding of the features and advantages of the provided systems and methods will be obtained by reference to the following detailed description which describes exemplary embodiments in which the principles of the invention are utilized, and to the appended drawings.

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DETAILED DESCRIPTION OF THE INVENTION

[0034] In the following detailed description, reference is made to the accompanying drawings which form a part hereof. In the drawings, like reference numerals typically identify like components unless the context indicates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized and other changes may be made without departing from the scope of the subject matter presented herein. The aspects of the present disclosure generally described herein and illustrated in the drawings can be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are readily understood to be explicitly contemplated herein.

[0035] This method and apparatus are well suited for combination with a plurality of alternative MIGS approaches for treating glaucoma, such as, for example, iStent®, iStent Inject, Cypass®. Although some embodiments refer to treatment without using a gonioscope, the methods and apparatus disclosed herein are also well suited for combined use with a gonioscope.

[0036] The methods and systems disclosed herein may enable a larger cohort of ophthalmic surgeons to perform MIGS procedures successfully. For example, the disclosed methods and apparatus can enable a surgery that more uniformly and consistently creates an opening that allows for improved outflow of aqueous humor from the anterior chamber of the eye to the Schlemm's canal. Further, the disclosed systems and methods can lead to improved surgical outcomes by enabling the surgeon to identify the target location of an opening into the Schlemm's canal intended to increase outflow. In some cases, the target location may include the surface or layer of tissue, or the location of tissue, such as, for example, the trabecular meshwork, juxtacanalicular trabecular meshwork (JCTM), the inner wall of the Schlemm's canal, the outer wall of the Schlemm's canal, the sclera, or a desired combination thereof.

[0037] The presently disclosed methods and devices may include a combination of a surgical microscope image and a sensing device that enables a surgeon to simultaneously view a real-time head-up display image. These real-time images can enable a surgeon to target and treat positions within the eye that are not easily visualized using only a surgical microscope, such as structures including the trabecular meshwork and Schlemm's canal. The methods and devices disclosed herein may enable a surgeon to view angular structures that are obscured or blocked by internal total reflection. For example, the disclosed methods and devices may use optical coherence tomography (OCT) technology to collect images or information of structures such as the ciliary channel system that are otherwise difficult or impossible to visualize by eye. A surgeon can simultaneously view a real image of the eye and an overlapping projected image of the intraocular structure, for example, by placing an image of an intraocular structure such as the ciliary channel system via a previously acquired OCT image of the ciliary channel system, and the OCT image is aligned with a visible marker to enable the surgeon to identify and target a preferred surgical site. In this way, the images viewed by the surgeon include a combination of a real (optical) image and a projected (virtual) image combined to enhance surgical targeting. Additional information may also be provided to the surgeon / viewer, such as a virtual image of a structure that is not visible by other means, and one or more symbols indicating both the distance and movement, such as from the tip of the probe to the trabecular meshwork to Schlemm's canal. In some embodiments, OCT imaging is used to identify the ciliary channels of the eye and enable a surgeon to identify the site (e.g., by using graphic visual elements such as treatment reference markers to identify the target position) and assist in creating an opening to increase the flow rate at the appropriate position of the trabecular meshwork of the eye. Embodiments of the present invention include any of a variety of OCT scan modalities or maps, including preoperative and / or intraoperative OCT maps, or images of the outflow system (e.g., Schlemm's canal and ciliary channels) that can be overlaid on a microscope image or view, such as that shown in FIG. 15.In some cases, for example, as shown in the image 610 of FIG. 6, one or more OCT images can be used to generate a virtual image of an angular structure. In some cases, for example, as shown in the feature portion 620 of FIG. 6, one or more OCT images can be used to generate a graphic depiction of the relationship between various structures and surgical instruments (e.g., fibers / probes).

[0038] Such a display can be coupled to a surgical microscope to present a monocular or binocular virtual image, for example, from a display that is visually coupled to the real optical images of both eyes of the eye. The methods and apparatuses disclosed herein are well suited for use in ELT surgery and implant device surgery that provides an opening for draining fluid from the eye. However, the systems and methods provided can also be applied to various other surgical procedures that can utilize fiber-optic based OCT, for example, surgeries using any and all endoscopes.

[0039] Although specifically referring to the treatment of glaucoma using excimer laser trabeculoplasty (ELT), the methods and systems disclosed herein can be used in many other types of surgeries. For example, the embodiments disclosed herein can be used in other surgical procedures including endoscopic procedures related to orthopedics, neurosurgery, neurology, otolaryngology (ENT), abdominal, thoracic, cardiovascular, endocardial, and other applications. The currently disclosed methods and devices can utilize OCT to improve the accuracy of targeting and provide virtual visualization to enable a surgeon to perform procedures in areas that are not easily visualized either microscopically or endoscopically. Such applications include any endoscopic surgery that extends virtual visualization to real images to assist in surgical accuracy in three-dimensional space, an example of which is endovascular surgery where blood vessels are curved or tortuous. Certain aspects can also be used to treat and correct soft tissues such as the brain, heart, lungs, intestines, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testicles, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, glands and mucosal tissues, spinal cord and nerve tissues, hard biological tissues such as cartilage, teeth, bone, as well as body cavities and passages such as the sinuses, ureters, colon, esophagus, lung passages, blood vessels, and other organs such as the larynx. For example, the devices disclosed herein may be inserted through existing body cavities or through openings created in body tissues.

[0040] Devices for performing glaucoma surgery are described in U.S. Patent Nos. 4,846,172 and 9,820,883, the entire contents of which are incorporated herein by reference.

[0041] To understand the described embodiments, a brief overview of the anatomical structure of the eye E is provided. As schematically shown in FIG. 1, the outer layer of the eye includes the sclera 17. The cornea 15 is a transparent tissue that allows light to enter the eye. The anterior chamber 7 is located between the cornea 15 and the iris 19. The anterior chamber 7 contains a continuously flowing transparent fluid called aqueous humor 1. The lens 4 is supported and moved within the eye by zonular fibers connected to the ciliary body 20. The iris 19, which is circumferentially attached to the scleral spur, includes the central pupil 5. The diameter of the pupil 5 controls the amount of light passing through the lens 4 and reaching the retina 8. The posterior chamber 2 is located between the iris 19 and the ciliary body 20.

[0042] As shown in FIG. 2, the anatomical structure of the eye further includes the trabecular meshwork (TM) 9, a triangular band of spongy tissue within the eye located in front of the insertion of the iris 19 into the scleral spur. The shape of the mobile trabecular meshwork varies and its size is microscopic. Typically, the cross-section is triangular and the thickness varies from about 100 to 200 μm. It is made of different fiber layers with micron-sized pores that form a fluid pathway for the aqueous humor to exit the anterior chamber. The trabecular meshwork 9 has been measured to a thickness of about 100 μm at its anterior edge, the Schwalbe line 18, which is approximately at the junction of the cornea 15 and the sclera 17.

[0043] The trabecular meshwork extends at its base to about 200 μm, and the trabecular meshwork and iris 19 are attached to the scleral spur. The height of the trabecular meshwork can be about 400 μm. The passage through the pores of the trabecular meshwork 9 passes through a very thin porous tissue called the juxtacanalicular trabecular meshwork 13 and then is adjacent to the inner wall of the Schlemm's canal 11, which is a vascular structure. The height of the Schlemm's canal can be about 200 μm, or about half the height of the trabecular meshwork. The Schlemm's canal (SC) 11 is filled with a mixture of aqueous humor and blood components and is connected to a series of collecting channels (CC) 12 that drain the aqueous humor into the venous system. Aqueous humor 1 is constantly produced by the ciliary body, flows into the anterior chamber through the pupil, passes through the pores of the TM and JCTM from there, and reaches the SC and aqueous veins. Therefore, any obstruction of the trabecular meshwork, juxtacanalicular trabecular meshwork, or Schlemm's canal prevents the aqueous humor from easily escaping from the anterior chamber of the eye. Since the eye is essentially a closed sphere, this causes an increase in intraocular pressure. An increase in intraocular pressure can lead to damage to the retina and optic nerve, which can ultimately cause blindness.

[0044] The obstruction of aqueous humor outflow that occurs in most cases of open-angle glaucoma (i.e., glaucoma characterized by a trabecular meshwork that is easily visible with a gonioscope) is usually localized in the region of the juxtacanalicular trabecular meshwork (JCTM) 13, which is located on the inner wall of the Schlemm's canal, between the trabecular meshwork 9 and the Schlemm's canal 11, more specifically.

[0045] For example, when an obstruction occurs in the juxtacanalicular trabecular meshwork 13, the intraocular pressure gradually increases over time. Therefore, the goal of current glaucoma treatment methods is to prevent damage to the optic nerve by reducing or delaying the progressive increase in intraocular pressure. Many people have searched for effective ways to lower and control intraocular pressure. Generally, various pharmaceutical treatments are employed to control intraocular pressure. These treatments can be effective for a certain period of time, but in many patients, the intraocular pressure often continues to rise. However, patients often cannot follow the prescribed treatment plan. As a result, glaucoma is not properly controlled, and the risk of irreversible damage to the optic nerve and ultimately vision loss increases.

[0046] Figure 3 is a cross-sectional side view of the internal anatomy of a human eye E showing an optical fiber probe 23 related to an embodiment of a method for treating glaucoma. After applying local, peribulbar, and / or retrobulbar anesthesia, a small self-sealing puncture incision 14 is created in the cornea 15. The anterior chamber is stabilized with either a chamber maintenance device using a fluid flow or a viscoelastic agent. The optical fiber probe 23 is then positioned and advanced into the anterior chamber 7 through the incision 14 until the distal end of the optical fiber probe 23 contacts and slightly compresses the desired target TM tissue.

[0047] Photodisruptive laser energy generated by a laser unit 31 (shown in FIG. 4) is delivered from the distal end of the optical fiber probe 23 that contacts the tissue to be ablated. The tissue to be ablated may include the trabecular meshwork 9, juxtacanalicular trabecular meshwork 13, and the inner wall of Schlemm's canal 11. The holes in the proximal inner wall of Schlemm's canal 11 are created in a way that does not penetrate the distal outer wall of Schlemm's canal. In some embodiments, additional holes are created in the target tissue. Thus, the resulting hole(s) are effective in restoring a relatively normal rate of aqueous humor drainage.

[0048] The optical fiber probe 23 may comprise one optical fiber or a plurality of optical fibers encapsulated by an optical fiber or an encapsulation sheath. The diameter of a single optical fiber must be large enough to transmit sufficient light energy to effectively effect photoablation of the target tissue and, in some embodiments, to enable OCT imaging of the target tissue. In some embodiments, the diameter of the optical fiber is in the range of about 4 to 6 μm. For example, a bundle with a diameter in the range of about 100 μm to about 1000 μm can be used for a single optical fiber or a plurality of optical fibers. The core and sheath can be placed within an outer metal sleeve or shield. In some embodiments, the sleeve is made of stainless steel. In some embodiments, the diameter of the sleeve is less than about 100 μm. In some embodiments, the diameter can be made as small as about 100 μm, such as when a smaller optical fiber is implemented in the laser delivery system. In some cases, the optical fiber may have a diameter of about 200 μm, and the optical fiber probe 23 may have a larger diameter, such as 500 μm, to encapsulate one or more optical fibers. In some embodiments, the sleeve can be flexible so that it can be bent or angled.

[0049] Figures 4 and 5 schematically illustrate a system 400 for assisting a physician in performing a surgical procedure on an eye E. The surgical procedure may include inserting an elongated probe 23 through an opening into the eye across the anterior chamber to a target tissue region including the trabecular meshwork and Schlemm's canal. In some embodiments, the system 400 may include an optical microscope 409 for the surgeon to visually observe the eye in real time during the procedure. An optical coherence tomography (OCT) device may be integrated within the optical microscope 409. The microscope may include, for example, a surgical microscope. The system 400 may include an OCT unit 401 configured to perform OCT scans of one or more target positions within the target tissue region during the procedure. The OCT unit 401 described herein may include, for example, a microscope OCT 403 or a fiber OCT 402, and combinations thereof. Images captured by the OCT unit 403 or 402 may be processed by an image processing device 412 of a control unit 410 to generate a plurality of enhanced images visually presented to the physician in real time. The enhanced images may be presented on the display of a head-up display 407 and, as is known to those skilled in the art, combined with an optical image from a microscope having an internal beam splitter to form a monocular or binocular image. As described elsewhere herein, the microscope view may include, for example, a "real" image, a "real" image and an overlaid virtual image, or an OCT image. When the microscope view includes an overlaid image, the overlaid image may be aligned with the "real" image using elements that enable such alignment. According to some embodiments, the surgeon may first visually identify a surgical instrument such as by looking at the "real" image of the microscope or a video image from the microscope. In some cases, the surgeon may visually identify an enhanced image or view. When OCT is overlaid on the "real" image, the surgeon may sometimes visually identify both the "real" image and the OCT image overlaid thereon. The enhanced images may be presented to the physician through the eyepiece(s) or ocular lens and / or the display of the microscope, and in some configurations, may be visually identified on a monitor screen.This can be beneficial to enable a surgeon to view, for example, overlapping or adjacent images or information, either stereoscopically or monocularly, simultaneously while maintaining stereoscopic vision of the surgical site through the microscope's eyepieces. OCT scans real-time images, thereby enabling the creation of 3D OCT images and / or OCT-based real-time information, which can be superimposed on the live view of one or both of the eyepieces. In some embodiments, the system and method provide a real-time view that includes real and virtual images from both the outer and inner sides of the anterior chamber during these surgeries.

[0050] The optical microscope 409 may be optically coupled to the OCT unit 401. The optical microscope 409 may comprise a binocular microscope, such as a stereomicroscope, having an imaging lens element that images an object onto the eyepiece(s) or ocular lens 408 and simultaneously with the camera 405. The camera 405 is configured to capture an optical image 505 of the eye. The optical image 505 may be transmitted to the control unit 410 for processing. The camera 405 may comprise optical elements (e.g., lenses, mirrors, filters, etc.). The camera may capture color images, grayscale images, etc.

[0051] The optical image 505 may be acquired at an appropriate image frame resolution. The resolution of the image frame may be defined by the number of pixels within the frame. The image resolution may be, for example, about 160x120 pixels, 320x240 pixels, 420x352 pixels, 480x320 pixels, 720x480 pixels, 1280x720 pixels, 1440x1080 pixels, 1920x1080 pixels, 2048x1080 pixels, 3840x2160 pixels, 4096x2160 pixels, 7680x4320 pixels, 15360x8640 pixels, or less than a larger pixel frame, or may be within a range defined by any two combinations of the previous pixel ranges. The imaging device or camera may have a pixel size smaller than, for example, 1 micron, 2 microns, 3 microns, 5 microns, 10 microns, 20 microns, etc. The camera 405 may be, for example, a color camera with a resolution of 4K or higher.

[0052] The captured optical image 505 may be a sequence of image frames captured at a specific capture rate. In some embodiments, the sequence of images may be captured at a standard video frame rate such as about 24p, 25p, 30p, 48p, 50p, 60p, 72p, 90p, 100p, 120p, 300p or higher, 50i or 60i. In some embodiments, the sequence of images may be captured at a rate of about 1 image or less every 0.0001 seconds, 0.0002 seconds, 0.0005 seconds, 0.001 seconds, 0.002 seconds, 0.005 seconds, 0.01 seconds, 0.02 seconds, 0.05 seconds, 0.1 seconds, 0.2 seconds, 0.5 seconds, 1 second, 2 seconds, 5 seconds, or 10 seconds. In some cases, the capture rate may vary according to user input and / or external conditions (e.g., illumination brightness) under the guidance of the control unit 410.

[0053] The optical image 505 may be captured in real time such that the image is generated with reduced latency, i.e., with a negligible delay between data acquisition and image rendering. Real-time imaging enables a surgeon to perceive a smooth flow of movement that coincides with the tactile movement of the surgeon's surgical instruments (e.g., an elongated probe and the tip of the probe) during surgery. Real-time imaging may include generating images at a rate faster than 30 frames per second (fps) to mimic a natural vision with continuity of movement and avoiding flicker (perception of intensity changes) at twice that rate. In many embodiments, the latency may include the time interval from the light from the OCT system illuminating the eye until the information is presented to the user and can be, for example, less than about 100 milliseconds. In many examples, the latency includes only one or two frames of the image presented on the display. In the case of embodiments including A-scan imaging from the distal end of a probe inserted into the eye, the latency can be less than the image frame rate, e.g., less than about 10 ms.

[0054] In some embodiments, the optical microscope 409 may be coupled to an electronic display device 407. The electronic display 407 may be a head-up display device (HUD). The HUD may or may not be a component of the microscope system 409. The HUD may be optically coupled to the field of view (FOV) of one or both of the eyepieces. The display device may be configured to project an augmented image 507 generated by the control unit 410 to the user or surgeon. The display device may be coupled to the microscope via one or more optical elements such as a beam splitter or a semi-reflective mirror 420 such that a physician looking through the eyepiece 408 can perceive, in addition to the real image, an augmented image presented and presented by the display device 407. The display device may be visible to the surgeon or user through a single eyepiece. Alternatively, the HUD may be visible through both eyepieces 408 and may be visible to the surgeon, for example, as a binocular image combined with the optical image formed by the components of the microscope.

[0055] The display device or head-up display 407 is in communication with the control unit 410. The display device may project the enhanced image generated by the control unit 410 onto the user in real time. As described herein, real-time imaging may include capturing an image without substantial latency and enabling a perception of a smooth flow of movement that coincides with the surgeon's tactile movement of the surgical instrument during the surgeon's procedure. In some cases, the display device 407 may receive one or more control signals from the control unit to adjust one or more parameters of the display, such as brightness, magnification, alignment, etc. The image that the surgeon or user views through the eyepiece or eyepiece 408 may be the direct optical view of the eye, the image displayed on the display 407, or a combination of both. Thus, adjusting the brightness of the image on the HUD may affect the surgeon's view through the eyepiece. For example, the processed information and markers shown on the display 407 can be balanced with the microscopic view of the object.

[0056] The head-up display 407 may be, for example, a liquid crystal display (LCD), an LED display, an organic light emitting diode (OLED), a scanning laser display, a CRT, etc., as known to those skilled in the art.

[0057] In some embodiments, the HUD 407 may comprise an external display. For example, in some embodiments, the HUD may not be perceptible through the eyepiece. The HUD may be located near the optical microscope. The HUD may, for example, comprise a display screen. The HUD may comprise a light emitting diode (LED) screen, an OLED screen, a liquid crystal display (LCD) screen, a plasma screen, or any other type of screen. The display device 407 may or may not be a touch screen. The surgeon may view the real-time optical image of the surgical site and the depth information simultaneously provided from the HUD by OCT.

[0058] The OCT unit 401 may be coupled to an optical microscope 409. The OCT unit 401 may comprise a microscopic OCT unit 403, a fiber optic-based OCT unit 402, or a combination of both. The OCT unit 401 may include swept source OCT (SS-OCT), spectral domain OCT (SD-OCT), Fourier domain OCT (FD-OCT), or time domain OCT (TD-OCT), as is known in the art as an OCT system. The OCT system may have a suitable resolution for visualizing eye tissue structures such as the Schlemm's canal and / or the collecting channels, for example, a resolution in the range of 1 to less than 10 microns, for example, in the range of about 3 to 6 microns. The OCT unit 401 may comprise a low coherence light source suitable for generating OCT image information and interference information. The OCT unit 401 may generate an OCT image having depth information and transmit the OCT image to the control unit 410. The OCT unit may be at least partially controlled by the control unit. The control of the OCT unit by the control unit may include, for example, activation of an OCT scan, parameter setting, or customizable control parameters.

[0059] The OCT unit may include a microscope OCT unit 403. The microscope OCT unit 403 may include components of the optical microscope 409, or may share components with the optical microscope. In some cases, the microscope OCT unit 403 may include a stand-alone OCT unit adapted for such use. The OCT unit of the microscope may be positioned at a location remote from the eye without contacting the eye. The OCT unit of the microscope may be operably coupled to the optical microscope. The microscope OCT unit may utilize one or more optical elements of the optical microscope, such as an objective lens. The microscope OCT unit 403 may be compatible with the optical microscope system 409. For example, the microscope OCT unit 403 may be configured to enable real-time adjustment of the OCT focal plane to maintain parfocality with the microscope view. In another example, the OCT unit of the microscope 403 may be able to adapt to changes in the refractive power of one or more optical elements of the optical microscope, such as the magnification of a lens such as the objective lens or other lens of the microscope. The microscope OCT unit 403 may be configured to acquire an OCT image using an engine (e.g., an SDOCT engine) that houses a light source (e.g., a NIR light source) and a detector (e.g., a line scan CCD). Depending on the type of OCT, a different spectrometer such as a CCD or a photodiode array detector may be used. The OCT unit of the microscope 403 may be configured to generate an OCT image as an A scan, a B scan, or a C scan depending on the scan principle. For example, an axial scan (i.e., an A scan) as a function of depth may be reconstructed by performing a fast Fourier transform (FFT). By moving a mirror in the x direction, a series of A scan lines are created, which can be stacked to create a B scan image or a two-dimensional image. By moving the mirror in both the x and y directions, a complete three-dimensional volume image or a C scan image (3D) can be generated. The mirror may be coupled to any suitable actuator known to those skilled in the art, such as a galvanometer, a translation stage, a MEMs actuator, or a piezoelectric crystal.In some embodiments, the microscopic OCT unit 403 may be activated to acquire a B-mode image and provide information regarding the position of the probe relative to the target positions along the front and back of the eye. In some cases, the microscopic OCT unit 403 may perform a C-scan to generate a three-dimensional image of the target tissue region.

[0060] The OCT unit may comprise an optical fiber-based OCT unit 402. According to some embodiments, the terms "optical fiber-based OCT unit" and "fiber-based device" may be used interchangeably. The optical fiber-based OCT unit 402 may comprise an optical fiber or an array of optical fibers that direct a laser light pulse into the eye structure and capture an image of the internal eye structure. The optical fiber-based OCT unit may also perform OCT imaging while delivering the laser light pulse. The optical fiber can be inserted into the eye and brought into contact with the tissue inside the eye. In some embodiments, the optical fiber can be the same fiber used in the optical fiber probe 23 that transmits the laser light. Alternatively, the optical fiber may be a separate fiber, such as a standard single-mode or multimode optical fiber. The separate fiber may be housed in the same optical fiber probe 23. For example, the optical fiber may be encapsulated in the encapsulated sheath of the probe 23, and the encapsulated sheath is configured to reinforce a single optical fiber. This enables accurate identification of the position of the tip of the probe 23 relative to the Schlemm's canal, TM, and other target tissues. In some embodiments, a separate optical fiber may be used to return the backscattered signal to the corresponding detector. A dichroic mirror 32 may be used to deflect the backscattered signal to the detector. In some embodiments, the optical fiber and the optical fiber probe of the OCT unit may be coaxial and function as a coaxial endoscope for identifying the position of the distal end of the probe relative to the target tissue. Alternatively, the optical fiber may be non-coaxial with the optical fiber probe. In some cases, the probe may include an array of OCT detection fibers positioned around the treatment fiber.

[0061] The fiber-optic based OCT unit 402 may be configured to generate axial scan images (A-scan images). This can be beneficial in providing real-time information regarding the relative position of the distal end of the probe with respect to the target site or target position. The A-scan images may be acquired at a high frequency, such as in the range of 10 Hz to 5 kHz. The A-scan images may be processed by the control unit 410 to generate an image including a plurality of position markers or distance markers corresponding to a plurality of positions of the target tissue and the probe tip. In some cases, a plurality of A-scan images may be averaged to generate an image for improving accuracy. Images from the A-scan(s) may be superimposed on the optical image to provide position information of the fiber-optic tip with respect to the target tissue along the axial direction of the probe.

[0062] The system 400 may further include a user interface 413. The user interface 413 may be configured to receive user input and output information to the user. The user input may be related to the control of surgical instruments, such as the operation of the probe 23. The user input may be related to the operation of an optical microscope (e.g., microscope settings, camera acquisition, etc.). The user input may be related to various operations or settings related to the OCT unit. For example, the user input may include selection of a target position, selection of a treatment reference marker, display settings for magnified images, customizable display settings, etc. The user interface may include a screen, such as a touch screen, and any other user-interactive external devices, such as a handheld controller, mouse, joystick, keyboard, trackball, touch pad, buttons, voice commands, gesture recognition, posture sensors, temperature sensors, touch-capacitance sensors, foot switches, or other devices.

[0063] In some embodiments, a microscope-based OCT 403 is used for guiding and visualizing the probe 23. In some embodiments, an optical fiber-based OCT 402 is used to guide and visualize the probe 23. In some embodiments, both a microscope-based OCT and an optical fiber-based OCT are used in the system and are used for guiding and visualizing the probe 23. The microscope-based OCT and the optical fiber-based OCT may perform OCT scans along one or more planes of the eye. In some cases, when both OCTs are used, the microscope-based OCT may be configured to perform a first OCT scan along the anterior-posterior plane of the eye, and the optical fiber-based OCT may be configured to perform a second OCT scan along an axis transverse to the anterior-posterior plane. In some cases, either the microscope-based OCT or the optical fiber-based OCT may be used independently.

[0064] The microscope-based OCT and the optical fiber-based OCT may or may not have similar scan resolutions. In some cases, the microscope-based OCT may perform scans at a higher scan resolution than the optical fiber-based OCT. For example, the B-scan performed by the microscope-based OCT may have a higher resolution than the A-scan performed by the optical fiber-based OCT. Alternatively, the scan resolution of the optical fiber-based OCT may be higher than that of the microscope-based OCT. The axial resolution may be determined based on the bandwidth of the source spectrum. The scan resolution may be determined to provide a fast frame rate sufficient to ensure real-time feedback. The resolution of each OCT system may be within the ranges described herein.

[0065] Microscope-based OCT and fiber-optic-based OCT may or may not have the same frame / scan rate. In some cases, microscope-based OCT performs B-scans and fiber-optic-based OCT performs A-scans, and a volume scan of the surgical site is not required. This can provide real-time position feedback at a higher rate. The frame rate of the cross-sectional views provided by microscope-based OCT and the axial views provided by fiber-optic-based OCT can be affected by various factors such as the size of the scan field, resolution, or scan rate. In some cases, the 2D OCT images (B-scans) acquired by microscope-based OCT can be used to provide a rough position of the probe relative to the target tissue or target location, in which case a relatively high resolution and slow frame rate may be sufficient. In some cases, the axial scan images (A-scans) acquired by fiber-optic-based OCT may provide a precise and accurate position of the distal end of the probe relative to small-sized structures (e.g., SC, CC, TM), and thus a higher frame rate may be desirable. In some cases, a high frame rate may be desirable to minimize motion artifacts and improve image quality. For example, the axial scan of fiber-optic-based OCT may have a 1D A-scan frame / scan rate of at least about 100 fps or more, and may have a structural image resolution in the range of, for example, about 1 micron to about 20 microns. In many embodiments, the A-scan frame rate is in the range of about 1 kHz to about 10 kHz. The OCT system may be configured to measure tissue up to a distance of at least about 10 mm from the probe tip, for example, at least about 6 mm from the probe tip, while in contact with the probe tip. With these distances, the probe tip can target the Schlemm's canal from a range of up to 6 mm from the target site or target location. In some embodiments, the OCT device may include phase-based OCT configured to detect movement of the distal end of the elongated probe, for example, movement in the range of about 20 nm to about 1 μm.

[0066] The system may provide the surgeon with augmented information superimposed on a live view of an optical image of the surgical site. This is beneficial in reducing interruptions in the surgical procedure by enabling the surgeon to view supplementary information without taking their eyes off the viewing optical system of the microscope or the head-up display. The augmented information may include an enlarged field of view of various regions of the eye on which they are operating at the top. The augmented information may include a depth view that includes position information of the probe with respect to the target tissue. The augmented information may include the guiding direction of the elongate probe. The augmented information may be provided to the surgeon substantially in real time. The augmented information may include real-time OCT images. The augmented information may include a plurality of visual graphic elements generated based on real-time OCT images and / or static OCT images. The terms "visual graphic element" and "graphic visual element" may be used interchangeably throughout this application. The augmented information may include still images and / or videos and / or information (text, graphics, charts, plots, etc.) that are superimposed on the optical microscope image displayed on the surgical field of view or screen of the surgical microscope.

[0067] In some cases, the augmented information may be superimposed or overlapped on the optical image acquired by the optical microscope to form an augmented image. The augmented image may be displayed on any screen such as a head-up display, a separate viewing monitor, or both. In some cases, the augmented information may be directly superimposed on the optical path image such that the field of view visible to the surgeon through the eyepiece of the microscope includes both the optical path image and the augmented information. In some cases, the augmented information may be superimposed on the optical image in a picture-in-picture format.

[0068] The control unit 410 may be configured to generate an extended layer including extended information. The extended layer may be a substantially transparent image layer including one or more graphic elements. The terms "graphic element" and "graphic visual element" may be used interchangeably throughout the present application. The extended layer may be superimposed on the optical view, optical image or video stream of the microscope and / or displayed on a display device. Due to the transparency of the extended layer, the user can visually recognize the optical image with graphic elements superimposed thereon. In some embodiments, the extended layer may include real-time OCT images or other information obtained by an OCT unit coupled to an optical microscope.

[0069] As described above, the fusion of the optical microscope image data and the extended information may include incorporating the extended information into the optical microscope image. The extended image data may include one or more graphic elements related to depth information, target position, and various other supplementary information. The graphic elements may be superimposed on the optical microscope image using, for example, a beam splitter. The graphic elements may be directly superimposed on the image of any object visible within the optical microscope image. The graphic elements may also include any shape, boundary, or contour surrounding the image of any object within the optical microscope image. The object may be, for example, an instrument (e.g., a probe) inserted into the eye, a part of the probe, a target tissue (e.g., SC, CC, TM, JCTM, sclera), etc.

[0070] In some embodiments, the graphic element may be configured to change dynamically as the position or orientation of the probe or instrument changes relative to the target position. For example, the graphic element may indicate the position of the distal end of the probe shown in the optical image, or the relative position or spacing between tissues such as the inner wall of the SC, TM, etc. The graphic element may, as the relative distance between the probe tip and the target position changes, and / or when the probe tip compresses the tissue (e.g., the surface of the trabecular meshwork), be configured to dynamically show the change in the spacing between tissue walls or the distance between the tip and the target position on the optical image substantially in real time or near real time.

[0071] In some embodiments, the extended information may include the orientation of the probe relative to the target position. The graphic element may indicate the orientation of the probe relative to the target position. The graphic element may be configured to dynamically show the orientation of the probe relative to the target position on the optical image substantially in real time or near real time as the orientation between the probe and the target position changes. In some examples, the graphic element may indicate the orientation or axial position of the elongated probe. To indicate the orientation (e.g., direction), the graphic element may be provided in the form of an arrow. The arrow may be configured to change dynamically based on the movement / advancement of the probe.

[0072] At least some of the extended layer or graphic elements may be mapped or matched to the optical image using pattern matching techniques such as object recognition technology or feature point recognition. The feature point may be a portion of the image (e.g., scleral landmark, collecting channel pattern, iris landmark, etc.) that can be uniquely distinguished from the rest of the image and / or other feature points within the image. The feature point may be detected in a portion of the image that is relatively stable under perturbation (e.g., when changing the illumination and brightness of the image).

[0073] FIG. 6 shows an exemplary extended image or extended view 600. As described above, the extended image 600 may be viewed binocularly by a user or surgeon through the eyepiece of a microscope, or may be displayed on a head-up display, an external display device, or a display coupled to a user interface. The extended image or view may include an optical image 505 or an optical path view through the eyepiece of an optical microscope. The optical image 505 may include a top-down view of the eye. The optical image or optical view may show the front of the eye. The optical image or optical view may further show the elongated probe 23. The extended image or view 600 may include a plurality of graphic visual elements and one or more OCT images adjacent to or superimposed on the optical image, for example, by optically coupling the display to the optical path of the microscope with a beam splitter. The plurality of graphic visual elements may include different shapes and / or colors corresponding to different objects so that the different objects shown in the optical image can be easily distinguished from each other.

[0074] The plurality of graphic visual elements may include one or more treatment reference markers 601, 602, 603 mapped to one or more target positions. As described elsewhere herein, the treatment reference markers 601, 602, 603 may correspond to target positions that are not optically visible to the surgeon in the optical image or the optical path view 505. According to some embodiments, the target position may be located inside the eye, and the treatment of the target position may include an approach inside the eye. In some cases, one or more target positions may be determined or identified based on preoperative OCT images. As described elsewhere herein, the preoperative and / or intraoperative OCT images may be acquired using either an approach inside the eye and / or an approach outside the eye. According to some embodiments, the treatment reference marker or target position may be selected based on a position within the target tissue region, which position provides a substantial increase in outflow following the formation of a channel (e.g., a channel passing through the trabecular meshwork, juxtacanalicular trabecular meshwork, and the inner wall of Schlemm's canal and thus providing fluid communication between the anterior chamber and Schlemm's canal). Such a selection may be based on the identification of a particular region within the collecting channel network, or a field that is denser or includes larger blood vessels or a larger distribution of blood vessels or is less occluded or corresponds to the circumferential flow area provided by Schlemm's canal. During real-time optical imaging, one or more treatment reference markers 601, 602, 603 may be superimposed on the target position by detecting the pattern of the target position identified from the preoperative OCT image (e.g., one or more specific collecting channels). In some cases, the user or surgeon may be prompted to select the target position or treatment reference marker(s) through the user interface 413. In some cases, the user or surgeon may be prompted to label or order the target positions selected for treatment. Thus, the user or surgeon can specify the desired sequence in which the target positions will be treated during the surgical procedure.For example, a user or surgeon can specify that treatment reference marker 601 corresponds to the target position that will be treated first, treatment reference marker 602 corresponds to the target position that will be treated second, and treatment reference marker 603 corresponds to the target position that will be treated third. Elsewhere in this specification, as described with reference to, for example, FIG. 15, treatment reference markers can be selected based on positions determined to correspond to larger collection channels, higher density collection channel networks or fields, and / or and larger outflows (e.g., positions within a target tissue region). In some cases, treatment reference markers can be selected in an automated manner. In some cases, treatment reference markers can be selected manually. The system can be configured to guide the surgeon to sequentially direct the laser fiber in the direction of each selected treatment reference marker. In some cases, multiple treatment reference markers may be shown simultaneously, such as at the start of a procedure for the user to select target positions. In some cases, multiple treatment reference markers may be shown sequentially as the surgery progresses.

[0075] The plurality of graphic visual elements may also include a probe line 604 coaxial with the elongated probe 23. The probe line 604 indicates the orientation of the probe with respect to one or more target positions. The plurality of graphic visual elements may also include a distal tip marker 605 that overlaps the distal end of the elongated probe. As the probe moves within the anterior chamber of the eye, both the probe line and the distal tip marker may be dynamically repositioned with respect to the actual position and orientation of the elongated probe shown in the optical image or view 505. Thus, for example, a surgeon can use a microscope to view the probe 23 as it enters the anterior chamber and as it is moved relative to the eye. The OCT detection mechanism can detect the probe 23, and an automated system or processor can generate the probe line 604 in response to the detection. Similarly, an automated system or processor can generate a guidance arrow 612.

[0076] The plurality of graphic visual elements may further include one or more guidance arrows or markers 612 that extend from the distal tip marker 605 towards one or more treatment reference markers (e.g., marker 601). The one or more guidance arrows 612 may be configured to guide a physician when aligning the distal end of the elongate probe towards one or more target positions during a procedure, or to guide the physician when advancing the elongate probe towards one or more target positions during the procedure. As described elsewhere herein, the one or more target positions may not be optically visible to the surgeon within the optical image or optical view 505. For example, when a target position is selected, a guidance arrow 612 may be generated that points from the distal end of the probe (or distal tip marker 605) to the selected target position (or corresponding treatment reference marker), whereby the physician can advance the probe parallel or coaxial to the guidance arrow. The one or more guidance arrows 612 may point radially in different directions from within the anterior chamber towards a target tissue region including the trabecular meshwork and Schlemm's canal. As described elsewhere herein, the height of Schlemm's canal may be about half the height of the trabecular meshwork. In some cases, one or more guidance arrows may be automatically displayed when the distal end of the probe is located at a predetermined distance from the target position, e.g., when the distal end of the probe is located at about 6 mm or less from the target position. Alternatively, one or more guidance arrows may be displayed in response to a user input indicating a target position selected from a plurality of target positions.

[0077] The extended layer may further include one or more OCT images superimposed on the optical image. The OCT image or OCT-based image may provide depth information or the position of the probe with respect to a target position in a plane extending in a direction across the optical image plane, e.g., a direction substantially perpendicular to the optical image plane. In some embodiments, one or more enlarged fields of view may be generated based on the OCT images 610, 620. For example, the OCT-based image may be enlarged at least 2 to 5 times compared to the optical image. For example, as shown in FIG. 6, the two-dimensional OCT image 610 obtained by microscopic OCT is superimposed on the optical image 505. In some cases, the scan used to generate the image 610 is performed during the procedure. The terms "microscopic OCT" and "microscope-based OCT" may be used interchangeably throughout this application. As described elsewhere in this specification, the two-dimensional OCT images 610-4, 610-5, 610-6, 610-7, and 610-8 may include embodiments, variants, or examples of the two-dimensional OCT image 610 and may include substantially similar characteristics. For example, one or more of these images may be generated based on an intraoperative scan. In some cases, the OCT image 610 may include a B-scan image. Alternatively or in combination, the OCT image 610 may be a three-dimensional image (C-scan). In some cases, a real-time or substantially real-time OCT image may be displayed overlapping the optical image in a picture-in-picture format. Alternatively or in combination, information derived from the OCT image may be superimposed on the optical image. In some embodiments, when the distal end of the probe is within a predetermined distance of the selected target position, a microscope-based OCT scan may be performed to generate the two-dimensional OCT image 610. The microscope-based OCT scan may extend along the current target position, e.g., the target position corresponding to the treatment reference marker 601, and the plane defined by the opening to the eye, the small incision (puncture) to the cornea described herein.

[0078] The two-dimensional image 610 may include a B-scan OCT image and one or more visual graphic elements. The B-scan OCT image may include, for example, a density plot. The horizontal axis may correspond to the direction of the lateral scan, and the vertical axis may correspond to the scan depth. The gray level may be plotted on a specific pixel on the OCT image corresponding to the magnitude of the depth profile at a specific depth and lateral scan position. The B-scan OCT image may be post-processed by the image processing device of the control unit 410 for image enhancement, image compression, etc. In some cases, the two-dimensional image 610 may be generated by averaging a plurality of B-scan OCT images such that the two-dimensional image is updated at a rate lower than the acquisition frame rate of the B-scan OCT image. Alternatively, the two-dimensional image 610 may be updated at the same frame rate as the acquisition frame rate of the B-scan OCT image.

[0079] The B-scan OCT image may be acquired along an OCT image plane along the long axis of the probe 23. The B-scan OCT image plane may be aligned with the probe line 604 along the anterior-posterior plane of the eye. For example, the probe axis may be determined by analysis of an optical image acquired by video, and the microscope-based OCT is controlled to align the OCT image plane with the long axis of the probe. The OCT plane of the microscope may be displayed to the user as a line extending along the probe axis, and the line is shown on the display and optically coupled to the microscope image.

[0080] In some cases, the two-dimensional OCT scan (B-scan) may be automatically performed in an area where the probe line intersects at least one treatment reference marker. The OCT scan area may include the anterior-posterior plane of the eye along the long axis of the probe. The OCT scan area may include a portion of the anterior-posterior plane, such as including a portion of the distal end of the probe and an area in front of the probe. The OCT scan area may not include the entire length of the probe. In some cases, the two-dimensional OCT scan may be automatically performed when it is detected that the probe line is substantially coaxially aligned with one or more guidance arrows and is oriented towards one or more treatment reference markers. In some cases, the two-dimensional OCT scan may be automatically performed when it is detected that the distal end of the elongated probe is at a predetermined distance from the target position. For example, the predetermined distance may be in the range of about 1 mm to 6 mm.

[0081] The two-dimensional OCT image 610 may further include a plurality of graphic visual elements superimposed on the OCT image. For example, one or more treatment reference markers 601-1 may be mapped to target positions within the OCT image. As described elsewhere herein, the OCT image may or may not be superimposed with graphic visual elements. In some cases, the graphic visual elements can be separated from the OCT image and not superimposed thereon. According to some embodiments, the OCT image may overlap with a microscopic image. For example, the OCT image may overlap with a microscopic image via a microscope, a display, or a microscope combined with a display. The plurality of graphic visual elements may also include a probe marker 611 indicating at least the position of the probe tip relative to the target position corresponding to the treatment reference marker 601-1 in the depth section. This provides depth information to the physician and thus guides the physician when adjusting the forward direction (i.e., depth) of the probe within the anterior-posterior plane of the eye. In some embodiments, for example, a guidance arrow 613 may also be superimposed on the OCT image to guide the movement of the probe towards the target position, whereby the surgeon can visualize the probe marker 611 advancing along the guidance arrow 613 towards the treatment reference marker 601-01. In some cases, the probe marker 611 may indicate or identify the orientation of the elongated axis of the probe with respect to, for example, the target position corresponding to the treatment reference marker 601-1. In some cases, the probe marker 611 may be coaxial with the long axis of the probe.

[0082] In some cases, the two-dimensional OCT image 610 may provide information regarding another OCT scan. For example, a fiber-optic based OCT scan is initiated based on the relative position information between the probe tip and the target tissue position, and the graphic element may be superimposed on the OCT image 610 indicating the scan range of the fiber-optic based OCT scan (e.g., arrow 614 in FIG. 7C). The scan range may be in a range such as 1 degree to 45 degrees. Alternatively, the fiber-optic based OCT scan may include A-scans.

[0083] The fiber-optic based OCT scan may be performed by the fiber-optic based OCT unit 402 as described above. The fiber-optic based OCT scan may be performed along the probe line 605 along the axis of the eye. The fiber-optic based OCT unit 402 may be configured to automatically perform an OCT scan when it detects that the distal end of the elongated probe is at a second predetermined distance from the target position. The second predetermined distance may be, for example, within the range of about 1 mm to about 6 mm. In some cases, the fiber-optic based OCT scan may be performed after the microscope-based OCT scan. In some cases, the fiber-optic based OCT scan may be performed independently of the microscope-based OCT scan. In one example, the fiber-optic based OCT scan may be activated when it is detected that the probe line is aligned with the guidance arrow, either within the x-y plane identified by the optical image or within the cross-sectional plane identified by the microscopic OCT image, or a combination of both. Alternatively, the fiber-optic based OCT scan may be manually activated.

[0084] In some embodiments, an image 620 or other information based on a fiber-optic based OCT scan may be generated and overlaid on an optical image in a picture-in-picture like format. In some cases, the scan used to generate the image 620 is performed during the procedure. In some embodiments, the image 620 may be generated by a microscope OCT. The image 620 may or may not include a fiber-optic based OCT image. The image 620 may be positioned near the tip of the probe. The image 620 may be positioned anywhere within the optical view or on an extended image. The OCT images 620-5, 620-6, 620-7, 620-8, 620-9, 620-90, and 620-91 described elsewhere in this specification (e.g., FIGS. 7D-7F and 9) are embodiments, variations, or examples of the OCT image 620 and may include substantially similar characteristics. For example, one or more of these images may be generated based on an intraoperative scan.

[0085] The image 620 may include a plurality of graphic visual elements 608, 609-1, 609-2, 609-3, 609-4, 609-5 generated based on a fiber-optic based OCT scan or a microscope-based OCT scan. In some embodiments, the fiber-optic based OCT scan is performed between the distal end of an elongated probe and a target location to generate an OCT A-scan of the target location, including a trabecular meshwork and a portion of Schlemm's canal. The plurality of graphic visual elements may include one or more A-scan distance markers 608, 609-1, 609-2, 609-3, 609-4, and 609-5. The A-scan distance marker may provide an enlarged distance view of the relative position between the probe tip and the tissue structure. The A-scan distance marker enables a physician to observe the distal end of the elongated probe when the distal end is not visible in an image collected by an optical microscope device, and also assists the physician in guiding the distal end of the elongated probe towards the target location and guides the surgeon regarding applying pressure to the trabecular meshwork. In some cases, the A-scan distance marker may be generated when the distal end of the elongated probe becomes unclear in the microscope image as a result of internal total reflection at the corner near the iridocorneal angle of the eye, rendering the distal end of the elongated probe not visible in the microscope image.

[0086] An A-scan distance marker may include a plurality of graphic visual elements that indicate relative distances between one or more of: the distal end of an elongated probe (identified by distance marker 608), the surface of the trabecular meshwork (identified by 609-1), the juxtacanalicular trabecular meshwork (JCTM) (identified by distance marker 609-2), the inner wall of Schlemm's canal (identified by distance marker 609-3), the outer wall of Schlemm's canal (identified by distance marker 609-4), or the sclera (identified by distance marker 609-5). According to some embodiments, distance markers 609-2 and 609-3 may be so close to each other as to be indistinguishable because the JCTM is a very thin membrane and is located adjacent to the inner wall of Schlemm's canal. In FIG. 6, the graphic elements are shown as lines and circles, but other shapes or colors may be used to mark the relative distances. The plurality of lines may include different colors, patterns, or thicknesses. The plurality of lines may be visually distinguishable from each other. The A-scan distance marker is overlaid on a microscopic image of the eye. The microscopic image shows a top-down view of the eye, and the A-scan distance marker shows an enlarged axial view of the target location. In some cases, the axial view of the target location is enlarged by at least 2 to 5 times.

[0087] As shown in FIG. 6, the plurality of graphic visual elements may include, for example, a first line or distance marker 608 corresponding to the distal end of the elongated probe, a second line or distance marker 609-1 corresponding to the surface of the trabecular meshwork, a third line or distance marker 609-2 corresponding to the juxtacanalicular trabecular meshwork (JCTM), a fourth line or distance marker 609-3 corresponding to the inner wall of the Schlemm's canal, a fifth line or distance marker 609-4 corresponding to the outer wall of the Schlemm's canal, and a sixth line or distance marker 609-5 corresponding to the sclera. Depending on the particular tissue structure, any number of lines or markers may be generated. One or more of the graphic visual elements may move relative to each other to reflect the real-time relative positions of the corresponding objects. For example, the first line 608 may appear to move relative to each of the second through sixth lines as the distal end of the elongated probe advances toward the target position. The plurality of lines allows the physician to know where the distal end of the elongated probe is located relative to the surface of the trabecular meshwork, the JCTM, the inner wall of the Schlemm's canal, the outer wall of the Schlemm's canal, and the sclera. The plurality of lines allows the physician to accurately advance the distal end of the elongated probe toward the target position, including the inner wall of the trabecular meshwork and the Schlemm's canal. In some cases, the plurality of lines allows the physician to advance the distal end of the elongated probe to apply gentle pressure to the trabecular meshwork, thereby avoiding overcompression of the trabecular meshwork. In some cases, due to compression of the trabecular meshwork, the thickness of the trabecular meshwork decreases from about 150 microns, for example, the original thickness, to about 90 microns. In some cases, the plurality of lines allows the physician to know whether the inner wall of the Schlemm's canal has been penetrated and to avoid penetrating the outer wall of the Schlemm's canal. For example, when the inner wall of the Schlemm's canal is penetrated, the lines 609-2 and 609-3 indicating that the probe tip has passed through the inner wall of the SC (or that the inner wall of the SC has been penetrated otherwise) may disappear from the magnified image, and in some cases, when the inner wall of the Schlemm's canal is penetrated, the physician may retract the elongated probe. For example, when penetration of the inner wall of the Schlemm's canal is detected, the emission of the laser may automatically stop.In some cases, when the inner wall of the SC is penetrated, the above method may inform the surgeon of the next target position shown in the image and where to direct the probe next to create another ablation channel in the inner wall of the Schlemm's canal. The target information may be generated from an optical fiber A scan of the new target position. Additionally or optionally, the target information may be generated from a microscope B scan of the new target position.

[0088] As described above, the penetration of the inner wall of the Schlemm's canal can be indicated by the disappearance of line 609-3, which is a graphic visual element corresponding to the inner wall of the Schlemm's canal (e.g., A-scan distance marker). In some cases, embodiments of the present invention are configured such that line 609-3 disappears from image 620 when the probe tip penetrates the inner wall of the Schlemm's canal. According to some embodiments, it can be assumed that the probe tip does not move significantly when the trabecular meshwork is compressed and the laser pulse is initiated. In some cases, embodiments of the present invention are configured such that line 609-3 disappears from image 620 when the laser pulse penetrates the inner wall of the Schlemm's canal. In some cases, embodiments of the present invention are configured such that line 609-3 disappears from image 620 when the ablated tissue structure distal to the probe tip is converted to gas and enters the Schlemm's canal. According to some embodiments, the laser pulse may penetrate the inner wall of the Schlemm's canal, or the gas ablation product may enter the Schlemm's canal, but the probe tip does not penetrate into the Schlemm's canal. According to some embodiments, the ablation channel can be created by ablation of the trabecular meshwork, juxtacanalicular trabecular meshwork, and the inner wall of the Schlemm's canal to form a pore. The compression of the trabecular meshwork can be monitored by evaluating the distance between line 609-1 corresponding to the surface of the trabecular meshwork and line 609-2 corresponding to the juxtacanalicular trabecular meshwork (JCTM). According to some embodiments, the penetration of the inner wall of the Schlemm's canal can be monitored by evaluating the distance between distance markers, which can be A-scan distance markers such as the distance between line 609-3 and line 609-4. For example, when the inner wall of the Schlemm's canal is penetrated and gas enters the Schlemm's canal, there may be a local and temporary expansion of the Schlemm's canal (e.g., as a result of the inflowing gas), and the distance between the inner wall and the outer wall of the Schlemm's canal may increase. At some point after penetration, when the Schlemm's canal collapses, the distance between the inner wall and the outer wall of the Schlemm's canal may decrease (e.g., from an initial distance of about 200 microns when the tube is expanded to a distance of about 20 microns when the tube collapses).

[0089] As described elsewhere in this specification, internal total reflection within the eye prevents the surgeon from visually identifying outflow structures that exist beyond the "critical angle" of the anterior eye optical viewing pathway. As shown in FIG. 6A, the surgeon can use an optical device 640a, such as an optical microscope, a camera, a video camera, etc., to visually identify structures such as the central iris 619a. This is because the light 650a from the central iris 619a passes through the cornea 615a and exits the eye 680a and is received or detected by the optical device 640a. In contrast, following internal total reflection due to the dome shape of the cornea, when using the optical device 640a, structures within and near the iridocorneal angle 670a, such as the trabecular meshwork 672a, are not visible to the eye. This is because the light 660a from the iridocorneal angle 670a undergoes internal total reflection at the interface between the anterior structures of the eye, including the cornea and the tear film 690a and air 695a (or other materials having a refractive index different from that of the anterior eye surface). Therefore, the light from structures such as the trabecular meshwork 672a does not exit the eye 680a through the cornea and cannot be received or detected by the optical device 640a.

[0090] When performing certain minimally invasive glaucoma surgery (MIGS) procedures and other medical treatments, the surgeon often moves an instrument, such as a probe, to various positions within the anterior chamber 607a of the eye 680a. When the instrument is located in the central or inner region of the anterior chamber 607a (e.g., near the central iris 619a and the pupil 605a), as indicated by the letter V, the instrument is optically visible to the surgeon directly and through the microscope. For example, the instrument can be seen within the optical path view or optical path image provided by the optical device 640a. In this sense, region V represents the region or space within the anterior chamber that is optically visible to the surgeon and can be seen, for example, within the image provided by the optical device 640a.

[0091] When the instrument (or a part thereof such as the distal tip) is positioned towards the peripheral or outer region of the anterior chamber (e.g., the periphery of line 655a near the trabecular meshwork 672a) such that it is indicated by the letter N, the instrument (or that part) is not optically visible to the surgeon. For example, the instrument (or a part thereof) would not be able to be seen within the view or image provided by the optical device 640a. In this sense, region N represents a region within the anterior chamber that is not optically visible to the surgeon and, for example, cannot be seen within the view or image provided by the optical device 640a.

[0092] The dashed line 655a provides a representative illustration of a boundary separating the space V (visible) from the space N (not visible) and corresponds to the "critical angle" described elsewhere in this specification. In relation, the dashed line 656a provides a representative illustration of the peripheral or outer boundary of the space N.

[0093] Current methods for visualizing structures that exist beyond the "critical angle" require the use of a device called a "gonioscope" that alters the optical path by changing the optics of the curved corneal surface. Contact lenses used for this purpose mainly fall into two categories: those that enable direct visualization of the iridocorneal angle 670a and those that enable indirect visualization of the iridocorneal angle 670a reflected, for example, using a mirror. The use of such devices to enable visualization of the iridocorneal angle structures requires a skill set to manipulate these contact lenses in real time and, in the case of indirect gonioscopes, to mentally reverse the mirror image.

[0094] Advantageously, embodiments of the present invention provide a system and method that enable a surgeon to effectively and accurately move and position a surgical instrument or probe, such as an excimer laser trabeculotomy (ELT) device, across various desired or target locations in the peripheral anterior chamber (e.g., across region N), such that without this, the view or image of the peripheral anterior chamber would be obscured or blocked due to total internal reflection. Further, embodiments of the present invention also enable a surgeon to effectively and accurately move and position a surgical instrument or probe, such as an ELT device, across various desired or target locations located peripherally to space N (e.g., through the trabecular meshwork 672a and the inner wall 625a of the Schlemm's canal 611a).

[0095] For example, according to embodiments of the present invention, a system and method are described that provide an extended view or image of a structure optically visualized with a gonioscope to a surgeon, where in this case the structure is instead imaged without using a gonioscope (e.g., a tissue or tissue layer such as the trabecular meshwork 672a), and further may include an image of a structure not visuallyizable with a gonioscope, including an OCT image of a target location of a target tissue region (e.g., a tissue or tissue layer such as the juxtacanalicular trabecular meshwork, the inner wall of the Schlemm's canal, the outer wall of the Schlemm's canal, and the sclera). Such images, when they are viewed, may be represented by a graphic image similar to the structure, or may be represented, for example, by graphic visual elements that identify a target location and relative positions. In this regard, in some cases, the graphic visual elements that identify a target location can operate to identify a specific tissue or tissue layer such as the trabecular meshwork, the juxtacanalicular trabecular meshwork, the inner wall of the Schlemm's canal, the outer wall of the Schlemm's canal, or the sclera.

[0096] By overlaying an OCT image and a graphic element, an extended view or an image can be generated, and the graphic element can be aligned with an optical path view or an optical path image. The extended view or image may also include graphic elements corresponding to the instrument and / or the target position. For example, the extended view or image may include a probe marker corresponding to the position of the probe or the probe tip. In some cases, the extended view or image may include graphic elements corresponding to the probe line or the guidance arrow. The graphic element is particularly useful in providing a visible guide cue to the surgeon for guiding optically non-visible spaces N and other regions or structures (such as the sub-surface tissue or tissue layer disposed under or around the trabecular meshwork 672a, such as the inner wall 625a of the Schlemm's canal 611a).

[0097] In this way, the surgeon is presented with an extended view or an image in which the target position and / or the instrument (or a part thereof) becomes "visually observable" to the surgeon by only one or more graphic visual elements or in combination with one or more OCT images, where the target position and / or the instrument (or a part thereof) is not visually observable within an optical view or an optical image without a gonioscope. Therefore, with the systems and methods disclosed herein, the surgeon can perform glaucoma surgery on the outflow structure (such as MIGS) without the need to use a gonioscope.

[0098] Panel (1) of FIG. 6A shows an additional aspect of the critical angle feature described herein. As shown here, light 650a from a position behind the cornea 615a having an angle of incidence "a" with respect to the normal 675a to the media boundary 685a (e.g., the interface between the tear film 690a and air 695a) intersects the boundary with partial refraction. In contrast, light 660a from a more peripheral position within the anterior chamber 607a having an angle of incidence "b" with respect to the normal 675a does not intersect the boundary 685a, but instead reflects back into the anterior chamber 607a. According to some embodiments, the critical angle "c" can be defined as the threshold angle of incidence beyond which total internal reflection occurs. Thus, it can be seen that for light 660a, there is total internal reflection that prevents the surgeon from visualizing certain outflow structures that exist beyond the critical angle "c" of the anterior segment optical visualization pathway. According to some embodiments, the critical angle "c" is about 46 degrees, and thus, light that exceeds an angle of 46 degrees at the boundary 685a, originating from a tissue structure or device positioned within the anterior chamber, reflects back into the anterior chamber. In some cases, the value of the critical angle can be determined based on the average value of a patient population. In some cases, the value of the critical angle can be determined based on a specific value for a particular patient during treatment. In some cases, the critical angle can correspond to a distance of about 3 mm to about mm from the surface of the trabecular meshwork.

[0099] FIG. 6B shows an exemplary extended image or extended view 600b. As described elsewhere in this specification, the extended image can be viewed by a user or surgeon through an eyepiece of a microscope, for example, on a head-up display adjacent to or on an optically visible structure. Such an extended image can be displayed on a head-up display, an external display device, or a display coupled to a user interface. According to some embodiments, the extended image 600 can be viewed in any of various views of a viewing device such as a display device, a microscope device, a head-up display, a viewing monitor, a virtual reality viewing device, an augmented reality viewing device, etc. As shown here, the extended image or view 600b can include an optical image 505b or an optical path view through an eyepiece of an optical microscope, and the optical image 505b includes a front or top-down view of an eye 607b having a sclera 17b. The optical image or optical view also shows an elongated probe 23b inserted into the anterior chamber of the eye through a corneal incision.

[0100] The extended image or view 600b also includes an OCT image 610b. As shown here, the OCT image 610b corresponds to a side or cross-sectional view of the eye. Further, the extended image or extended view 600b can include another OCT image 620b. As shown here, the image 620b corresponds to a front or top-down view of the eye.

[0101] The dashed line 655b provides an exemplary illustration of a boundary separating a non-optically visible space N within the anterior chamber from an optically visible space V within the anterior chamber, and this boundary corresponds to the "critical angle" visibility described elsewhere in this specification. In this regard, the dashed line 656b provides an exemplary illustration of the perimeter or outer boundary of the space N within the anterior chamber.

[0102] Embodiments of the present invention enable a surgeon to effectively and accurately move and position a surgical instrument, such as a probe, across various desired or target locations within the peripheral anterior chamber (e.g., across the entire space N), or else the optical image or view of the peripheral anterior chamber would be blocked due to total internal reflection, and also to direct the surgical instrument to other regions or structures that are not optically visible (e.g., subsurface tissue or tissue layers disposed beneath or peripheral to the trabecular meshwork 672b). For example, as described elsewhere herein, the OCT images 610b and 620b may include graphic visual elements disposed at or at least partially disposed around the periphery of the dashed line 655b.

[0103] As shown here, the OCT image 610b includes a graphic visual element 611b corresponding to an elongated probe 23b disposed in a space V, which is a space within the anterior chamber that is optically visible to the surgeon. The portion of the iris behind the elongated probe may not be visible within the image 610b (e.g., under the graphic visual element 611b) due to the OCT shadowing phenomenon, thereby potentially creating an optical shadowing that obscures the tissue underlying the OCT image. In relation, the OCT image 620b similarly includes a graphic visual element 608b corresponding to the distal end 623b of the elongated probe 23b disposed in the space V. The dashed line 624b represents the position of the probe distal end 623b.

[0104] As described elsewhere in this specification, for example with reference to FIG. 6C, as the surgeon moves the distal end of the elongate probe from space V to space N, the distal end of probe 23b will disappear from the optical image or view 505b, while with the OCT image 610b, the surgeon can seamlessly visualize the probe over this transition by observing as the graphic visual element 611b is moved from space V to space N and optionally to other regions or structures (e.g., the subsurface tissue or tissue layer disposed under or around the trabecular meshwork 672b). Similarly, with the OCT image 620b, the surgeon can seamlessly visualize the probe over this transition by observing as the graphic visual element 608b is moved from space V to space N and optionally to other regions or structures (e.g., the subsurface tissue or tissue layer disposed under or around the trabecular meshwork). According to some embodiments, the boundary itself (i.e., the dashed line 655b) is described herein for illustrative purposes only and is not displayed anywhere in the extended image or view 600b.

[0105] FIG. 6C shows an exemplary extended image or view 600c. Here, the distal end (not shown) of probe 23c is advancing from space V (the position shown in FIG. 6B) to space N as indicated by the dashed line 624c in the optical view or image 505c. The extended image or view 600c also includes the OCT image 610c. As shown herein, the OCT image 610c corresponds to a side or cross-sectional view of the eye. The iris portion behind the elongate probe may not be visible within the image 610c (e.g., under the graphic visual element 611c) due to the OCT shadowing phenomenon. Further, the extended image or view 600c may include another OCT image 620c. As shown herein, the image 620c corresponds to a front or top-down view of the eye 607c.

[0106] The dashed line 655c provides an exemplary illustration of a boundary that separates the optically non-visible space N within the anterior chamber from the optically visible space V within the anterior chamber, and this boundary corresponds to the "critical angle" visibility described elsewhere in this specification. According to some embodiments, the boundary itself (i.e., the dashed line 655c) is described herein for illustrative purposes only and is not displayed anywhere in the extended image or view 600c. In this regard, the dashed line 656c provides an exemplary illustration of the perimeter or outer boundary of the space N within the anterior chamber.

[0107] The OCT images 610c and 620c may include graphic visual elements disposed around or at least partially disposed around the dashed line 655c. As shown herein, the OCT image 610c is disposed in the space V (the space within the anterior chamber that is optically visible to the surgeon) and includes a graphic visual element 611c corresponding to the elongated probe 23c that extends into the space N (the space within the anterior chamber that is not optically visible to the surgeon). In this regard, the OCT image 620c includes a graphic visual element 608c corresponding to the distal end of the elongated probe 23c disposed in the space N.

[0108] Since the surgeon moved the distal end of the elongated probe 23c from space V to space N, the distal end of the probe has disappeared from the optical image or view 505c. However, during this movement, by means of the OCT image 610c, the surgeon can seamlessly visualize the probe over this transition from space V to space N by observing the distal portion 612c of the graphic visual element 611c that moves from space V to space N. Optionally, the surgeon can be guided by other graphic visual elements overlaid with the OCT image 610c, as described elsewhere in this specification, to move the probe over various positions in space N. During this guided navigation process, the surgeon can visualize the position and / or location of the probe 23c relative to the anatomical structures of the eye 607c by observing the movement of the graphic visual element 611c (and optionally, the distal portion 612c) relative to other graphic visual elements using the OCT image 610c. For example, the other graphic visual elements may correspond to subsurface tissue or tissue layers disposed under or around the trabecular meshwork 672c.

[0109] Similarly, with the OCT image 620c, the surgeon can seamlessly visualize the movement of the probe over this transition from space V to space N by observing as the graphic visual element 608c is moved from space V to space N. Optionally, the surgeon can be guided by other graphic visual elements overlaid with the OCT image 620c, as described elsewhere herein, to move the probe across various positions in space N. During this guided navigation process, the surgeon can use the OCT image 620c to visualize the position and / or location of the probe 23c relative to the anatomical structures of the eye 607c by observing the movement of the graphic visual element 608c relative to the other graphic visual elements. For example, the other graphic visual elements may correspond to subsurface tissue or tissue layers disposed beneath or around the trabecular meshwork. In some cases, the graphic visual element 608c may be generated as a result of the distal end of the elongated probe becoming obscured within the microscopic image, due to internal total reflection at the corners near the iridocorneal angle of the eye, such that the distal end of the elongated probe is not visible within the microscopic image.

[0110] Accordingly, embodiments of the present invention are well-suited for use in visualization and guidance within and around structures of the eye near the iridocorneal angle, such as the trabecular meshwork and Schlemm's canal, the use of which would otherwise require more difficult techniques, such as techniques that require the use of a gonioscope. Similarly, the systems and methods disclosed herein can enable a surgeon to visualize angular structures blocked by internal total reflection by providing the surgeon with images or information of structures that are poorly visible or not visible, such as a convergent channel system. Such images or information can be generated by using optical coherence tomography (OCT) technology.

[0111] Figures 7A - 7F show exemplary enlarged images 700, 710, 720, 730, 740, 750, 760, 770, 780, and 790 that may be perceived by a physician or user during a procedure. As shown in Figure 7A (image 700), one or more treatment reference markers 601, 602, 603 corresponding to one or more target positions may be superimposed on an optical image of the eye or an optical path view through an eyepiece of an optical microscope for a physician to visually identify and select. In the optical image or view shown here, it is possible to visualize the anatomical structures of the eye within the anterior chamber from the pupil to the trabecular meshwork. However, as described elsewhere herein, peripheral structures at or near the iridocorneal angle, such as the trabecular meshwork, may not be visible in the optical image or view. Thus, according to some embodiments, the optical images or views provided herein are for illustrative purposes only and may not actually include such peripheral structures. The one or more target positions may be determined from a preoperative OCT image or other image and then mapped to a live optical image as described elsewhere herein. When a target position is selected, a guidance arrow 612 (shown in image 710) extending from a distal tip marker 605 corresponding to the selected target position toward the selected treatment reference marker 601 may be generated to guide the physician to orient the probe longitudinally with the guidance arrow. In some cases, treatment reference markers 602, 603 corresponding to unselected target positions may disappear from the view after the first treatment reference marker 601 (or corresponding target position) is selected. Proceeding to Figure 7B (image 720), the probe may be advanced toward the selected target position corresponding to the treatment reference marker 601 guided by a probe line 604 coaxial with the long axis of the probe and the guidance arrow 612. When it is detected that the probe tip is within a predetermined distance from the target position, or as shown in Figure 7C (image 730) when the probe line is aligned with the guidance arrow, an OCT scan may be performed. In this regard, the OCT scan may be performed in a state where it is detected that the probe tip exceeds the "critical angle" visibility, and as a result, an image 610 - 4 may be generated.As described elsewhere in this specification, the detection may be based on live optical images. The OCT scan may be a microscope-based OCT scan, and in some cases, a 2D image may be overlaid on the optical image. In some cases, if a 3D scan (i.e., a C-scan) is desired, an arrow 614 indicating the scan range of the microscope-based OCT may be overlaid on the optical image. The scan range or volume may be defined by two arrows 614 pointing from the fiber tip to the target position. Alternatively, the microscope-based OCT may be a 2D scan (i.e., a B-scan). The scan plane may be along the longitudinal axis of the probe and the anterior-posterior plane of the eye. The scan range may be from the optical fiber tip to the target position, as indicated by arrow 612. In some cases, arrow 614 may indicate the scan range of the fiber-optic-based OCT. Similarly, arrow 614 may define the scan range of a 3D scan or a 2D scan of the fiber-optic-based OCT. The scan range may be within a range defined by an angle 714, such as from 1 degree to 45 degrees.

[0112] As shown in image 740, the microscope-based OCT image 610-4 may include a guidance arrow 613 to guide the physician when adjusting the orientation and forward direction of the probe within the anterior-posterior plane of the eye. Alternatively, the guidance arrow may indicate the 3D OCT scan range. This OCT image supplements position information that may not be perceptible in the optical image. As described elsewhere in this specification, a probe marker 611 indicating at least the position of the probe tip relative to the target position corresponding to the treatment reference marker 601-1 may be overlaid on the microscope-based OCT image. As explained elsewhere in this specification, the height of Schlemm's canal may be approximately half the height of the trabecular meshwork. According to some embodiments, the guidance arrow 613 points in the direction towards Schlemm's canal. The position of the treatment reference marker 601-1 can be made to correspond to the position of Schlemm's canal.

[0113] As shown in FIG. 7D (image 750), when the distal tip marker 605 corresponding to the distal end of the elongated probe approaches the treatment reference marker 601 corresponding to the target position and it is detected that the distal tip marker 605 is within a predetermined distance from the treatment reference marker 601 (or when it is detected that the distal end is within a predetermined distance from the target position), a second OCT scan may be performed. The second OCT scan may be an optical fiber-based OCT scan that can be used to generate image 620-5. In some cases, the second OCT scan may be a B scan, and the arrow indicating the scan range may be superimposed on the optical image 610-5. Alternatively, the second OCT scan may be an A scan along the axis of the probe, and the scan range may not be shown on the magnified image. The magnified view of the second OCT scan (A scan or image 620-5) may be superimposed on the optical image in a picture-in-picture-like format. For clarity, FIG. 7D shows a magnified view of the A scan image 620-5 showing a plurality of A scan distance markers, and the magnified view may be superimposed on the magnified image. The plurality of A scan distance markers, such as lines, are generated based on the A scan results and may be superimposed on the optical image. The distance markers (e.g., the optical fiber tip position marker 608, the TM distance marker 609-1) may dynamically change their position or spacing to reflect the relative position between the distal end of the probe and the surface of the trabecular meshwork, the JCTM, the inner wall of the Schlemm's canal, the outer wall of the Schlemm's canal, or the sclera.

[0114] Accurate and precise positioning measurements of the probe tip and associated markers can be used in combination with various ophthalmic surgeries. In one example, an ELT procedure may be performed under the guidance of an enhanced image. As shown in the example, the plurality of A-scan distance markers may include a distance marker 608 corresponding to the distal end of an elongated probe or the tip of an optical fiber, a distance marker 609-1 corresponding to the surface of the trabecular meshwork, a distance marker 602-2 corresponding to the juxtacanalicular trabecular meshwork (JCTM), a distance marker 609-3 corresponding to the inner wall of Schlemm's canal, a distance marker 609-4 corresponding to the outer wall of Schlemm's canal, or a distance marker 609-5 corresponding to the sclera. The outer wall of Schlemm's canal may be relatively fixed with respect to the overall eye structure, while the inner wall of Schlemm's canal can move with the trabecular meshwork with respect to the overall eye structure. Due to normal physiological processes, the distance between the inner and outer walls of Schlemm's canal can vary dynamically, for example, between about 20 microns (e.g., when filled only with aqueous humor) and 200 microns (e.g., when filled with aqueous humor and red blood cells). The accuracy of the ELT laser probe is on the order of 1.7 microns per pulse, and thus it can be operated to effectively ablate the inner wall of Schlemm's canal without ablating the outer wall. As described elsewhere herein, when the distance marker 609-3 corresponding to the inner wall of Schlemm's canal disappears due to penetration of the inner wall, a signal can be sent to the laser to stop delivery of ablation pulses, and a signal indicating that penetration is complete can be provided to the surgeon. In this way, the system can provide an automatic stop signal, an information stop signal, or both.

[0115] As shown in FIG. 7D (image 760), as the microscopic image shows the distal tip marker 605 moving towards the treatment reference marker 601, in the OCT image 610-6, the real-time image can show the probe marker 611 moving towards the trabecular meshwork 9. Thus, as the probe tip advances towards the target, the surgeon can visually observe the displayed movement of the probe. As shown in the OCT image 620-6, as the probe tip advances towards the target, the optical fiber tip distance marker 608 may move closer to the distance marker corresponding to the target tissue region, and the distance markers may include the trabecular meshwork and Schlemm's canal, as shown by distance markers 609-1 (corresponding to the trabecular meshwork), 609-2 (corresponding to the juxtacanalicular trabecular meshwork), 609-3 (corresponding to the inner wall of Schlemm's canal), 609-4 (corresponding to the outer wall of Schlemm's canal), and 609-5 (corresponding to the sclera). For clarity, FIG. 7D shows an enlarged view of the A-scan image 620-6 showing a plurality of A-scan distance markers, and the enlarged view may be superimposed on the extended image.

[0116] As shown in FIG. 7E (extended image 770), when the probe tip is in contact with the trabecular meshwork, as shown in the OCT image 610-7, the probe marker is in contact with the trabecular meshwork, and the distance marker 609-1 may disappear from the OCT image 620-7. When the tip of the probe is in contact with the trabecular meshwork, photoablation of the target tissue may be performed. The probe coupled to the energy source may be configured to deliver a plurality of pulses to the target location when it detects that the distal end of the elongated probe is compressing a portion of the trabecular meshwork. As described herein, the plurality of pulses are configured to create a hole through the trabecular meshwork into Schlemm's canal by photoablation. For clarity, FIG. 7E shows an enlarged view of the A-scan image 620-7 showing a plurality of A-scan distance markers, and the enlarged view may be superimposed on the extended image.

[0117] As shown in FIG. 7E (expanded image 780), the A-scan distance markers of the OCT image 620-8 may indicate penetration of the inner wall of the Schlemm's canal. For example, as shown in the OCT image 610-8, when the inner wall of the Schlemm's canal is penetrated, the lines 609-2 and 609-3 indicating that the probe tip has passed through the inner wall of the SC (or that the inner wall of the Schlemm's canal has been penetrated in another manner) may disappear from the expanded image 780, and in some cases, when the inner wall of the Schlemm's canal is penetrated, the physician may retract the slender probe. According to some embodiments, the fiber-optic based OCT can be used to detect tissue structures within the target tissue region and can be used to detect when the inner wall of the Schlemm's canal has been ablated and penetrated. In this regard, since the ablation process converts tissue to gas, detection of gas within the Schlemm's canal (previously filled only with liquid, e.g., plasma or aqueous humor) can be used as another marker to identify that the inner wall of the Schlemm's canal has been penetrated. For example, when penetration of the inner wall of the Schlemm's canal is detected, the emission of the laser may automatically stop. Alternatively, in another example, the user may be notified by the processor to manually stop the laser emission. For clarity, FIG. 7E shows an enlarged view of the A-scan image 620-8 showing a plurality of A-scan distance markers, and the enlarged view may be superimposed on the expanded image.

[0118] When the control unit 410 detects that the distal end of the elongated probe is compressing a portion of the trabecular meshwork, it may include a steering and control unit 414 configured to automatically control an energy source to deliver a plurality of pulses. Alternatively, the steering and control unit 414 may be configured to generate an alert to the physician to manually control the energy source to deliver a plurality of pulses when it detects that the distal end of the elongated probe is compressing a portion of the trabecular meshwork. In some cases, the steering and control unit 414 may be configured to determine the amount by which a portion of the trabecular meshwork is compressed by the distal end of the elongated probe based on an A-scan distance marker. For example, the amount of compression of the trabecular meshwork is determined based on a change in the relative distance between a first distance marker corresponding to the surface of the trabecular meshwork and a second distance marker corresponding to the JCTM. In another example, the steering and control unit 414 is configured to determine whether a portion of the trabecular meshwork is compressed to a predetermined thickness based on an A-scan distance marker. In some cases, the steering and control unit 414 may be configured to control an energy source to deliver a plurality of pulses and, when it determines that a portion of the trabecular meshwork is compressed to a predetermined thickness, cause photoablation of a portion of the trabecular meshwork and the inner wall of the Schlemm's canal.

[0119] Returning to FIG. 7E, the energy source may stop delivering multiple pulses to the target location when it detects that the inner wall of the Schlemm's canal has been penetrated by a laser pulse. Penetration of the inner wall of the Schlemm's canal may be indicated by the disappearance of the line marker 609-3 corresponding to the inner wall of the Schlemm's canal. In some cases, the steering and control unit 414 may be configured to detect whether the inner wall of the Schlemm's canal has been penetrated by photoablation of a portion of the trabecular meshwork, based in part on a change in the relative distance between the A-scan distance markers. In some cases, when the steering and control unit 414 detects that the inner wall of the Schlemm's canal has been penetrated, it is further configured to generate an alert to the physician to retract the elongated probe away from the target location. The alert may be in any form, such as text, a graphic visual element superimposed on an optical image, or an audible alert.

[0120] As shown in FIG. 7F (Image 790), the steering and control unit may be further configured to generate an alert to the physician to identify another treatment reference marker corresponding to the mapped position of another target location in the eye when the current surgery has been successfully completed. For example, when it is detected that the inner wall of the Schlemm's canal has been penetrated and the laser pulse has been stopped, a subsequent treatment reference marker 602 corresponding to the next target location may appear and can guide the surgeon to move to the next treatment position, as described elsewhere in this specification. Some or all of the foregoing steps may be repeated for subsequent target locations. For clarity, FIG. 7F shows an enlarged view of the A-scan image 620-9 showing multiple A-scan distance markers, and the enlarged view may be superimposed on the extended image.

[0121] FIG. 8 shows another example of a system 800 according to an embodiment. The system 800 may be substantially similar to the system 400 described in FIG. 4 and may include one or more components of the system 400. The system 800 may measure the eye E with OCT using only the fiber optic-based OCT 402. The microscope 409 may include the same optical microscope as described in FIG. 4. In this case, the OCT unit 401 may include only the fiber optic-based OCT 402, and the OCT unit may not share the optical components of the microscope 409. The distance from the trabecular meshwork can be determined using the A-scan information provided by the probe. The surgeon can align the probe with the Schlemm's canal using the A-scan information provided on the display. For example, the A-scan information can be displayed to the surgeon along with an indication of the distance from the Schlemm's canal and an indication of whether the distal end of the fiber optic probe is aligned with the Schlemm's canal.

[0122] FIG. 9 shows exemplary extended images or optical views 900 and 910 presented to the user during a procedure using system 800. The steps of overlaying guidance arrows, probe markers, probe tip marker 605, treatment reference markers on the optical image or view may be similar to those described for images 700, 710, and 720 in FIGS. 7A and 7B. The orientation and forward direction of the probe may be adjusted so that the axis marker of the probe aligns with the guidance arrow. Alignment of the probe in the x - y plane may be achieved by using a top - down view of the optical image of the eye. The position of the probe relative to the target position in the anterior - posterior plane may be estimated or calculated from the pre - operative OCT image. When it is detected that the probe tip (corresponding to distal tip marker 605) is within a predetermined distance from the target position (corresponding to treatment reference marker 601), an optical - fiber - based OCT scan may be performed. The optical - fiber - based OCT scan may be an axial scan (i.e., A - scan) or a B - scan as described above. The optical - fiber - based OCT scan may be the same as those described elsewhere in this specification. An enlarged view 620 - 90 of the OCT results may be overlaid on the optical image. The OCT image 620 may include a plurality of A - scan distance reference markers such as 608, 609 - 1, etc., described above. Alternatively, the OCT image may include a two - dimensional OCT live image when a B - scan is performed. The OCT images 620 - 90 and 620 - 91 are useful for guiding the physician when advancing the tip axially and provide information regarding the relative position of the probe tip with respect to one or more tissue structures (e.g., trabecular meshwork 609 - 1). For example, as shown in FIG. 910, as the tip advances, the distance marker 608 in the OCT image 620 - 91 may move towards other distance markers. For clarity, FIG. 9 shows an enlarged view of A - scan images 620 - 90 and 620 - 91 showing a plurality of A - scan distance markers, and the enlarged view may be overlaid on the extended image.

[0123] FIG. 10 shows another example of the system 1000 according to an embodiment of the present invention. The system 1000 may utilize only the microscope-based OCT unit 403. The OCT unit of the system 1000 may include a microscope-based OCT. In this case, the OCT-based extended information superimposed on the optical image may be provided by an OCT scan performed by the microscope-based OCT unit 403. For example, when it is detected that the probe tip is within a predetermined distance from the target position, a microscope-based OCT scan may be performed. The scan plane may be along the anterior-posterior plane of the eye E and along the elongated axis of the probe, as described elsewhere in this specification. The OCT scan may be a high-resolution scan. For example, the structural scan resolution may be in the range of about 1 μm to about 5 μm. The scan may provide position information of the probe tip relative to the target position or tissue structure (e.g., trabecular meshwork, juxtacanalicular trabecular meshwork (JCTM), inner wall of Schlemm's canal, outer wall of Schlemm's canal, or sclera). In some cases, a real-time OCT image having a marker such as image 610 may be generated and superimposed on the optical image. In some cases, in addition to image 610, a magnified view of the relative position of the probe tip and the tissue structure such as image 620 may be generated based on the microscope-based OCT and superimposed on the optical image.

[0124] FIG. 11 schematically shows an example of an OCT guidance system 1100 according to an embodiment of the present invention. System 1100 may include the same components as system 400 described in FIG. 4, except that system 1100 may not include a separate laser unit for an optical fiber probe. System 1100 may be used to guide any surgical instrument inserted into the eye E, as described elsewhere herein. For example, system 1100 may provide guidance for identifying the stent position of an implant. Examples of implant devices include CyPass® microstent and iStent®, which target the suprachoroidal space and Schlemm's canal, respectively. In this case, the optical fiber for OCT scanning may be coaxial with a surgical tool 1101 that may not include an optical fiber for ELT surgery.

[0125] FIGS. 12A-12D show examples of instruments that can be used in combination with the provided system. The various instruments may not be coupled to a laser light source. The device may have a substantially elongated shape. As shown in the anterior view of the eye shown in FIG. 12A, the extended information may be overlaid on the optical view or image 505 of the eye and the instrument in a manner similar to that described elsewhere herein. For example, one or more treatment reference markers 601, and an arrow or probe line 604 coaxial with the instrument 24 may be overlaid on the optical image. As shown here, the eye includes the iris 19, trabecular meshwork 9, and cornea 15. It is understood that instead of showing the cornea 15, this image could show the sclera instead of the cornea. In the optical image or view 505 shown here, it is possible to visualize the anatomical structures of the eye within the anterior chamber, from the inner pupil to the iridocorneal angle. However, as described elsewhere herein, peripheral structures at or near the iridocorneal angle, such as the trabecular meshwork 9, may not be visible in the optical image or view. Thus, according to some embodiments, the optical image or view provided herein is for illustrative purposes only and may not actually include such peripheral structures.

[0126] A guidance arrow 612 may be displayed to guide the forward direction and orientation of the instrument 24. In some cases, the optical fiber for OCT scanning may be coaxial or encapsulated within the housing of the instrument 24 to provide the relative position of the distal end of the instrument with respect to the treatment position. In some cases, the elongate probe 24 may include one or more stents 1220a mounted thereon, and the stent 1220a may be configured to be embedded in the trabecular meshwork 9 to connect the anterior chamber to the Schlemm's canal and create a permanent opening in the Schlemm's canal. Embodiments of the systems described herein may be configured to assist a physician in advancing and implanting one or more stents 1220a at a target location with the aid of graphic visual elements (e.g., treatment reference markers and arrows) aligned with the actual microscopic image of the eye. For example, the disclosed system may be configured to assist a physician in laterally advancing and sliding the stent 1220a into the Schlemm's canal and permanently positioning the stent in the Schlemm's canal with the aid of graphic visual elements (e.g., treatment reference marker 601, probe line 604, and / or guidance arrow 612) aligned with the microscopic image.

[0127] In some cases, the system may be configured to assist a physician in advancing a plurality of stents along the elongated axis of an elongated probe, injecting the plurality of stents into the Schlemm's canal, and permanently positioning the plurality of stents in the Schlemm's canal, with the aid of graphic visual elements aligned with a microscopic image. For example, as shown in panel (1) of FIG. 12B, the elongated probe 1210b includes a housing 1212b and an insertion mechanism 1214b. As shown in panel (2), a stent 1220b may be mounted to the insertion mechanism 1214b, and the stent 1220b may include a head 1222b, a chest 1224b, a flange 1226b, and an outflow orifice 1228b. Panel (3) of FIG. 12B shows two stents 1220b embedded in the trabecular meshwork 9 as viewed from the anterior chamber. As shown here, the flange 1226b of each stent 1220b includes an inlet orifice 1227b that is in fluid communication with one or more outflow orifices (not shown). Since the stent 1220b does not extend significantly from the trabecular meshwork 9 towards the central part of the anterior chamber, the stent is not visible within the microscopic image or view as a result of being obscured by internal total reflection at the corners near the iridocorneal angle of the eye. The OCT guidance embodiments disclosed elsewhere in this specification are well suited to assist a surgeon in delivering a stent (while mounted on an elongated probe) to the trabecular meshwork 9. For example, using the OCT guidance embodiment described with reference to FIG. 6, a surgeon can be assisted in guiding the implantation of a stent at a target location in the trabecular meshwork. In some cases, the target location can correspond to the location of the collecting channels or can be based on the distribution or density of a plurality of collecting channels. Referring again to FIG. 12B, as shown in panel (4), when the stent 1220b is implanted in the eye, the flange 1226b is in the anterior chamber 7, the chest (not visible) is in the trabecular meshwork 9, and the head 1222b is in the Schlemm's canal 11. Since the inlet orifice is in fluid communication with the outflow orifice, aqueous humor can flow from the anterior chamber into the Schlemm's canal.

[0128] As shown in panels (1)-(7) of FIG. 12C, in some cases, the elongated probe 1210c may include a micro-stent 1220c mounted therein, and the micro-stent 1220c may be configured to create a permanent conduit between the anterior chamber 7 and the suprachoroidal space 27. In some cases, the stent 1220c may include a sleeve 1221c, such as a titanium sleeve, an inlet 1222c, a retention mechanism 1223c, and an outlet 1224c. The systems disclosed herein may be configured to assist the physician in advancing the micro-stent 1220c into the suprachoroidal space 27 with the aid of graphic visual elements aligned with the microscopic image. For example, the system may be configured to assist the physician in advancing the micro-stent 1220c into the suprachoroidal space 27 using a real-time OCT image of the suprachoroidal space 27 generated by any of the OCT devices described elsewhere herein. The system may also be configured to assist the physician in positioning the proximal collar portion or sleeve 1221c of the micro-stent 1220c at the anterior chamber angle 28 with the aid of graphic visual elements aligned with the microscopic image. The OCT guidance embodiments disclosed elsewhere herein are well-suited to assist the surgeon in delivering the stent (while mounted on the elongated probe) to the anterior chamber angle. For example, using the OCT guidance embodiment described with reference to FIG. 6, it is possible to assist the surgeon in guiding the implantation of the stent at the target location in the anterior chamber angle.

[0129] In some cases, as shown in panels (1)-(4) of FIG. 12D, the elongated probe 1210d may include a gel stent 1220d configured for subconjunctival filtration mounted on top. As shown in panel (1), an injector or an elongated probe 2120d can be inserted through the incision in the cornea 15 and advanced across the anterior chamber 7. As shown in panel (2), the elongated probe can be further advanced into the subconjunctival space 27. Panel (3) shows the deployment of the distal portion of the gel stent 1220d into the subconjunctival space. Panel (4) shows the gel stent 1220d in the implanted position, and the gel stent 1220d functions to drain aqueous humor from the anterior chamber 7 into the subconjunctival space 27. The gel stent 1220d may be configured to create a channel through the sclera to allow the flow of aqueous humor from the anterior chamber to the subconjunctival space. The systems disclosed herein may be configured to assist a physician in positioning and implanting the gel stent 1220d with the aid of graphic visual elements aligned with microscopic images. For example, OCT guidance embodiments disclosed elsewhere herein are well suited to assist a surgeon in delivering a stent (while mounted on an elongated probe) into the subconjunctival space. In this regard, the OCT guidance embodiments described with reference to FIG. 6 can be used to assist a surgeon in guiding the implantation of a stent into a target location in the subconjunctival space.

[0130] FIG. 13 shows a flowchart of a method 1300 for determining a target treatment position and a probe position according to an embodiment. This method may use one or more of the systems described herein. In a first step 1301, a front image of the eye may be acquired by a camera of an optical microscope or a video camera. In a second step 1303, one or more target positions (or treatment reference markers corresponding to the target positions) are overlaid or mapped onto an optical image or an optical view for the user. The one or more target positions may be determined based on reference image data including an OCT image of the eye. The OCT image of the eye may be acquired using an OCT device before a surgical procedure. In some cases, the OCT image of the eye may include an image of the anterior part of the eye including the trabecular meshwork of the collecting channels, and one or more individual collecting channels in at least two quadrants may be identified from the OCT image. The resolution of the preoperative OCT image may be high.

[0131] FIG. 15 shows an example of a preoperative OCT image 1500, and extended preoperative OCT images 1510 and 1520 showing collecting channels and target positions. As shown in the example, the preoperative OCT image may be a 3D image. One or more collecting channels and / or target positions may be identified from the high-resolution preoperative image. As described elsewhere herein, the trabecular meshwork 9 is in fluid communication with a series of collecting channels 12 or mesh (via the Schlemm's canal). The OCT image 1500 shows the position 9a of the trabecular meshwork 9 associated with the subsurface tissue where the number or density of the collecting channels 12 is relatively high. In contrast, the position 9b of the trabecular meshwork 9 is associated with the subsurface tissue where the number or density of the collecting channels 12 is relatively low.

[0132] In some cases, extended information such as a guidance arrow 613 may be overlaid on the preoperative image. For example, a guidance arrow 613 that can be used to guide a slender probe towards a target position is overlaid on the preoperative OCT image 1510. As shown in FIG. 15, the preoperative OCT image 1510 can also be combined with a microscopic view or a microscopic image 1505 that can see the iris 19 and the slender probe 23.

[0133] As described elsewhere in this specification, a treatment reference marker can correspond to or be mapped to a target location within an OCT image. In some cases, one or more target locations can be identified or specified in the OCT image. In some cases, one or more target locations (e.g., 621, 622) are located at positions corresponding to one or more individual collecting channels proximate to the trabecular meshwork and the inner wall of Schlemm's canal (or, alternatively, positions corresponding to one or more regions including a high-density mesh or field of collecting channels). As shown herein, treatment reference marker 601 can be overlaid on the OCT image and / or a microscopic view or an image of target location 621, and treatment reference marker 602 can be overlaid on the OCT image and / or a microscopic view or an image at target location 622. In some cases, the positions of one or more individual collecting channels (or mesh regions) may be aligned with at least one distinguishable anatomical structure in the eye, such as the iris. The plurality of target locations may be manually estimated by the user or automatically estimated by a processor. As described elsewhere in this specification, the user or physician may be enabled to select a target location through a user interface. According to some embodiments, the techniques for identifying the target locations and / or treatment reference markers shown in FIG. 15 can be used in combination with subsequent gonioscopy-assisted treatments. According to some embodiments, the techniques for identifying the target locations and / or treatment reference markers shown in FIG. 15 can be used in combination with other OCT-guided techniques described herein, for example, with reference to FIG. 6. As shown in FIG. 15, an OCT image can be used to identify and / or target collecting channels or a collecting mesh. The target location can be selected based on a location where the collecting channels are larger and / or the density of the collecting channel mesh or field is higher (e.g., the 4 o'clock position), as opposed to a location where the collecting channels are smaller and / or the density of the collecting channel mesh is lower (e.g., the 2 o'clock position).In some cases, the target location can be designated at a location of the Schlemm's canal close to the collecting channel, where the density of the target channel network or field is higher and / or the collecting channel, network, or field is least obstructed (e.g., maximum outflow). In some cases, the target locations can be each assigned or ordered based on these size, density, and / or obstruction or flow parameters. In some cases, an OCT image can be used to determine where the flow within the Schlemm's canal is circumferential and / or where the flow is segmented, and the target location can be selected to correspond to where the flow is circumferential. In some cases, the surgeon can use an OCT image such as that shown in FIG. 15 to make a determination regarding where to position or move a treatment probe or device without the need for assignment of the target location or overlay of graphic visual elements. For example, the OCT image may show the collecting channel, network, and / or field, and the surgeon may make a determination regarding positioning or movement of the probe based on such anatomical features. The OCT image enables the surgeon to identify the target location or desired treatment location positioned within the tissue without the need to label or mark the target location or treatment location, for example, with graphic visual elements or treatment reference markers.

[0134] Referring again to FIG. 13, in the third step 1305, one or more guidance graphic elements may be superimposed on the optical image so that the physician can adjust the forward direction and / or orientation of the probe and move it towards at least a selected target position in the optical image plane. In the fourth step 1307, when it is detected that the probe tip is within a predetermined distance from the target position, a microscope-based OCT image may be acquired along the longitudinal axis of the probe and the anterior-posterior plane of the eye. Next, at 1309, the microscope-based OCT image and the associated markers may be overlaid on the optical image to guide the physician when adjusting the orientation and forward direction of the probe within the OCT image plane. In the sixth step 1311, an optical fiber-based OCT scan may be performed along the axis of the probe. The optical fiber-based OCT scan may be an A-scan or a B-scan to provide the relative position between the probe tip and the tissue when the probe tip is within a predetermined distance from the target position. The optical fiber-based OCT image and / or the distance marker generated based on the OCT image may be overlaid on the optical image 1313. In the eighth step 1315, the treatment may be displayed or visualized in real time at the treatment position to adjust the movement of the probe based at least in part on the extended information.

[0135] Although FIG. 13 shows a method according to some embodiments, those skilled in the art will recognize many adaptations to the variant forms. For example, the steps can be performed in any order. Some of the steps may be deleted, some of the steps may be repeated, and some of the steps may include sub-steps of other steps. This method may also be modified according to other aspects of the present disclosure provided herein.

[0136] As shown in FIG. 13A, embodiments of the present invention include a method of performing a surgical procedure at a target location of a patient's eye. An exemplary treatment method 1300a includes, as shown by step 1310a, viewing a real-time view on a viewing device, and, as shown by step 1320a, advancing the distal end of an elongate probe within the anterior chamber of the eye toward a target tissue region while viewing the viewing device, and, as shown by step 1310c, performing a surgical procedure using the elongate probe while the distal end of the elongate probe is not visible within the microscopic view or microscopic image provided by the viewing device and while perceiving information from the microscopic view or microscopic image regarding the relative position of the distal end of the elongate probe with respect to the target location. According to some embodiments, the target location is positioned at a target tissue region of the patient's eye. In some cases, the real-time view includes a microscopic view or an enhanced image of the eye. The enhanced image may include a microscopic view or a microscopic image of the eye. The enhanced image may further include an optical coherence tomography (OCT) image of the target tissue region. The OCT image may be aligned with the microscopic view or the microscopic image. A graphic visual element corresponding to the target location may be overlaid on the microscopic view or the microscopic image. The target location may not be visible within the microscopic view or the microscopic image. According to some embodiments, the method includes advancing the distal end of an elongate probe within the anterior chamber of the eye toward a target tissue region while viewing the microscopic view or the enhanced image on the viewing device. In some cases, the distal end of the elongate probe is initially visible within the microscopic view or the microscopic image and then becomes not visible within the microscopic view or the microscopic image due to internal total reflection within the region of the eye. In some cases, this region of the eye includes the target tissue region. In some cases, this region exceeds the visibility of the "critical angle" as described elsewhere herein.

[0137] As shown in FIG. 13B, an embodiment of the present invention includes a method for assisting a surgeon in performing a surgical procedure on a patient's eye. As shown here, method 1300b includes providing a real-time view to the surgeon, as indicated by step 1310b. In some cases, the real-time view includes a microscopic view of the eye 1320b. In some cases, the real-time view includes an enhanced image, such as enhanced image 1330b or enhanced image 1340b. In some cases, the enhanced image 1330b (version (A)) may include a microscopic view of the eye. In some cases, the enhanced image 1340b (version (B)) may include a microscopic image of the eye 1350b. Either version of the enhanced image (i.e., enhanced image 1330b or enhanced image 1340b) may include an OCT image 1360b of the target tissue region of the eye. The OCT image 1360b can enable identification of the target location. In some embodiments, the surgeon 1390 can view the microscopic view 1320b and then either the enhanced view 1330b or the enhanced view 1340b. Thus, the surgeon 1390 can be provided with two different versions of the real-time view, namely the microscopic view 1320b and the enhanced image 1330b, or the microscopic view 1320b and the enhanced image 1340b. According to some embodiments, the OCT image 1360b can be aligned with the microscopic view 1320b or the microscopic image 1350b. According to some embodiments, the actual target location is not visible within the microscopic view 1320b or the microscopic image 1350b. According to some embodiments, the enhanced image (1330b or 1340b) enables the surgeon 1390b to perceive information regarding the relative position of the distal end of the elongate probe with respect to the target location when the distal end of the elongate probe is not visible within the microscopic view 1320b or the microscopic image 1350b.

[0138] In some embodiments, when the surgeon 1390b first inserts the treatment probe into the anterior chamber of the patient's eye, the surgeon views the microscopic image 1320b. Subsequently, an OCT image 1360b (e.g., showing the collecting channels or the meshwork) can be overlaid on the microscopic image 1320b using alignment techniques as described elsewhere herein. Thereafter, the surgeon may determine where to deliver the treatment (e.g., laser ablation energy directed to the trabecular meshwork, juxtacanalicular meshwork, and the inner wall of Schlemm's canal). In some cases, this may include the surgeon labeling or marking the treatment location using graphic visual elements or treatment fiducials. In some cases, a computerized system may determine where to place the graphic visual elements or treatment fiducials. Following the above steps, the surgeon can move or position the treatment probe within the anterior chamber of the eye and use subsequent OCT imaging protocols to facilitate guiding or directing the probe to the target or desired treatment location (e.g., by overlaying graphic visual elements). In some cases, the graphic visual elements can be overlaid on the microscopic view or image before placing the probe in the anterior chamber. In some cases, following placement of the probe in the anterior chamber, the graphic visual elements can be overlaid on the microscopic view or image. In some cases, the graphic visual elements can be overlaid on the OCT image before placing the probe in the anterior chamber. In some cases, following placement of the probe in the anterior chamber, the graphic visual elements can be overlaid on the OCT image.

[0139] The control unit 410 (e.g., as shown in FIGS. 4, 5, 8, 10, or 11) may include one or more processors (e.g., processor 1405 as shown in FIG. 14) configured to implement one or more steps shown in FIGS. 13, 13A, and 13B and operations described elsewhere in this specification. Similarly, the control unit 410 may include or be connected to any other component of the computer system (e.g., computer system 1401 as shown in FIG. 14).

[0140] The specific methods and apparatus disclosed herein are described in the context of ablation, but the user interface and display may be configured to direct the surgical placement of the implant as described herein. For example, the target location can be indicated with reference to the set of channels, and the surgical placement of the implant can be directed to a target location, e.g., near the Schlemm's canal. Using the arrows and other features shown on the head-up display, the placement of multiple positions of multiple surgical implants disposed within the eye, such as an implant for creating an opening into the Schlemm's canal, can be directed. The implant can be placed, for example, by mechanically creating an opening (e.g., using a sharp instrument) in the Schlemm's canal and placing the implant at the target location.

[0141] Each of the calculations or operations described herein may be performed using a computer or other processor having hardware, software, and / or firmware. The various method steps may be performed by modules, which may include any of a variety of digital and / or analog data processing hardware and / or software configured to perform the method steps described herein. The modules may optionally include data processing hardware configured to perform one or more of these steps in association with appropriate machine programming code, and modules of two or more steps (or portions of two or more steps) may be integrated on a single processor board in any of a variety of integrated and / or distributed processing architectures or separated onto different processor boards. These methods and systems will often use a tangible medium that embodies machine-readable code along with instructions for performing the method steps described elsewhere in this specification. All features of the described systems are applicable to the described methods with the necessary modifications, and vice versa.

[0142] The processor may be a hardware processor such as a central processing unit (CPU), a graphics processing unit (GPU), or a general-purpose processing unit. The processor can be any suitable integrated circuit, such as a computing platform or a microprocessor, a logic device, etc. Although the present disclosure is described with respect to processors, other types of integrated circuits and logic devices are also applicable. The processor or machine may not be limited by data manipulation capabilities. The processor or machine can perform data manipulations of 512 bits, 256 bits, 128 bits, 64 bits, 32 bits, or 16 bits.

[0143] In some embodiments, the processor may be a processing unit of a computer system. FIG. 14 shows a computer system 1401 that may be configured to implement any of the computing systems or methods disclosed in this application. The computer system 1401 may include a mobile phone, a tablet, a wearable device, a laptop computer, a desktop computer, a central server, and the like.

[0144] The computer system 1401 includes a central processing unit (CPU, also referred to herein as a "processor" and a "computer processor") 1405, which can be a single-core or multi-core processor, or multiple processors for parallel processing. The CPU can be a processor as described above. The computer system 1401 also includes a memory or memory location 1410 (e.g., random access memory, read-only memory, flash memory), an electronic storage unit 1415 (e.g., hard disk), a communication interface 1420 (e.g., network adapter) for communication with one or more other systems and peripheral devices 1425 such as cache, other memory, data storage devices, and / or an electronic display adapter. In some cases, the communication interface may enable the computer to communicate with another device such as an imaging device or an audio device. The computer may be able to receive input data from a coupled device for analysis. The memory 1410, storage unit 1415, interface 1420, and peripheral devices 1425 communicate with the CPU 1405 through a communication bus (solid lines) such as a motherboard. The storage unit 1415 can be a data storage unit (or data repository) for storing data. The computer system 1401 can be operably coupled to a computer network ("network") 1430 with the assistance of the communication interface 1420. The network 1430 can be the Internet, the Internet and / or an extranet, or an intranet and / or extranet communicating with the Internet. The network 1430 can be a telecommunications and / or data network in some cases. The network 1430 can include one or more computer servers that enable distributed computing such as cloud computing.In some cases, network 1430 can implement a peer-to-peer network with the assistance of computer system 1401, whereby devices coupled to computer system 1401 may be able to act as clients or servers.

[0145] CPU 1405 can execute a sequence of machine-readable instructions that can be embodied in a program or software. The instructions may be stored in a memory location such as memory 1410. The instructions can be directed to CPU 1405, and CPU 1405 can subsequently be programmed or otherwise configured to implement the methods of the present disclosure. Examples of operations performed by CPU 1405 can include fetch, decode, execute, and write-back.

[0146] CPU 1405 can be part of a circuit such as an integrated circuit. One or more other components of system 1401 can be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).

[0147] Storage unit 1415 can store files such as drivers, libraries, and saved programs. Storage unit 1415 can store user data, such as user preferences and user programs. Computer system 1401 can include one or more additional data storage units external to computer system 1401, such as being located on a remote server communicating with computer system 1401 through an intranet or the Internet in some cases.

[0148] The computer system 1401 can communicate with one or more remote computer systems through the network 1430. For example, the computer system 1401 can communicate with a user's remote computer system. Examples of remote computer systems include personal computers, slate or tablet PCs, smartphones, portable information terminals, and the like. A user can access the computer system 1401 via the network 1430.

[0149] The methods described herein may be implemented by machine (e.g., computer processor) executable code stored in an electronic memory location of the computer system 1401, such as, for example, the memory 1410 or the electronic storage unit 1415. The machine executable or machine readable code may be provided in the form of software. In use, the code may be executed by the processor 1405. In some cases, the code can be retrieved from the storage unit 1415 and stored in the memory 1410 for immediate access by the processor 1405. In some situations, the electronic storage unit 1415 can be excluded and the machine executable instructions can be stored in the memory 1410.

[0150] The code can be pre-compiled and configured for use on a machine having a processor adapted to execute the code, or can be compiled during execution. The code can be provided in a programming language selected such that the code can be executed in a pre-compiled or compiled manner.

[0151] Aspects of the systems and methods provided herein, such as computer system 1401, may be embodied in programming. Various aspects of the technology are typically considered a "product" or "manufacture" in the form of machine (or processor) executable code and / or associated data, and are carried or embodied in a type of machine-readable medium. The machine executable code may be stored in an electronic storage unit such as a memory (e.g., read-only memory, random access memory, flash memory) or a hard disk. A "storage device" type of medium may include any or all of the tangible memories of a computer, processor, etc., or associated modules that provide non-transitory storage for software programming at any time, such as various semiconductor memories, tape drives, disk drives, etc. All or part of the software may be communicated over the Internet or other various communication networks. Such communication may, for example, enable the loading of software from one computer or processor, such as an administrative server or host computer, to an application server computer platform. Thus, another type of medium that may hold software elements includes optical, electrical, and electromagnetic waves such as those used between physical interfaces of local devices, through wired and optical fixed telephone networks, and via various air links. Physical elements that carry such waves, such as wired or wireless links, optical links, etc., may also be regarded as a medium holding software. As used herein, the term "readable medium" of a computer or machine refers to any medium involved in providing instructions to a processor for execution, unless limited to non-transitory tangible "storage" media.

[0152] Thus, machine-readable media such as computer-executable code can take many forms including, but not limited to, tangible storage media, carrier wave media, or physical transmission media. Non-volatile storage media includes, for example, optical or magnetic disks such as any storage device of any computer(s) that can be used to implement, such as the databases shown in the drawings. Volatile storage media includes dynamic memory such as the main memory of such a computer platform. Tangible transmission media includes coaxial cables, copper wire and fiber optics, and wires including buses within a computer system. Carrier wave transmission media may take the form of electrical or electromagnetic signals, or acoustic or light waves such as those generated during radio frequency (RF) and infrared (IR) data communications. Thus, common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tape, any other magnetic media, CD-ROM, DVD or DVD-ROM, any other optical media, punch card paper tape, any other physical storage media, RAM, ROM, PROM and EPROM, FLASH-EPROM, any other memory chip or cartridge, carrier waves that carry data or instructions, cables or links that carry such carrier waves, or any other media that a computer can read programming code and / or data from. Many of these forms of computer-readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.

[0153] The computer system 1401 can include, or communicate with, for example, an electronic display 1435 that includes a user interface 1440 for providing an administrative interface. Examples of UIs include, but are not limited to, a graphical user interface (GUI) and a web-based user interface. The user interface 1440 may be the same as the user interface 413 described in FIG. 4. Alternatively, the user interface may be a separate user interface.

[0154] The computer system 1401 may include various other computer components to facilitate communication with external devices such as a microscope system, a camera, an OCT unit, a laser unit, an external processor, or memory. The communication module may include suitable means for command and data transfer such as double data rate. Various means can be used for communication, such as computer buses including, but not limited to, a peripheral component interconnect card, PCI Express, PCI-X, HyperTransport. Suitable communication means may be selected according to the compatibility requirements with the bandwidth of the external device and the central processing unit 1405. For example, one data bus may be for command transfer to the laser unit 31 (e.g., an AXI4 write bus), and a different data bus (e.g., an AXI4 bus) may be used for image data transfer. Alternatively or additionally, wireless communication may be used.

[0155] The methods and systems of the present disclosure can be implemented by one or more algorithms. The algorithms can be implemented by software when executed by the central processing unit 1405.

[0156] As used herein, terms such as "overlay", "overlaid", "superimpose", "superimposed" may also include, in some embodiments, other image or information combination techniques such as "place under", "placed under", "underlying", and similar approaches. Composite or fused images, views, information, or displays that can combine or blend images, graphic visual elements, and / or information, etc., that may exist in a single layer or multiple layers, may be generated or provided by any of these techniques.

[0157] Any of the embodiments of the systems, devices, or methods disclosed herein may involve or include usage systems, devices, or methods such as those disclosed in U.S. Patent Publications Nos. 2004 / 0082939, 2012 / 0283557, 2016 / 0095751, and 2017 / 0202708, and U.S. Patents Nos. 4,846,172, 6,251,103, 8,540,659, 8,679,089, 9,603,741, 9,642,746, 9,820,883, and 9,833,357, each of which is hereby incorporated by reference in its entirety.

[0158] Reference is made to determining the position of the collecting channels using markers shown on a display, but using a method and apparatus as disclosed herein, the eye can be marked preoperatively at the position corresponding to the collecting channels. The surgeon can use these marks to create an opening in the Schlemm's canal according to the markings placed on the eye. For example, the eye can be marked with ink to identify the preferred surgical treatment location, and an opening can be created in the trabecular meshwork at the position corresponding to the preferred surgical treatment. Although preferred embodiments of the invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Here, numerous variations, modifications, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein can be used in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within these claims and their equivalents be covered thereby.

Claims

1. A system comprising: a laser light source; a processor configured to: receive optical coherence tomography (OCT) image data of a target in-vivo eye tissue; process the optical coherence tomography (OCT) image data to identify collecting ducts within the eye tissue; identify one or more target candidate positions within the eye tissue that are targets for laser treatment to form one or more openings within the eye tissue based on the collecting ducts identified by processing the optical coherence tomography (OCT) image data; select one or more target positions from among the one or more target candidate positions, either independently or in response to user input; generate an optical coherence tomography (OCT) image of the eye tissue; the processor; a visual observation device configured to generate a visual display of at least a portion of the in-vivo eye; one or more viewing devices; wherein the laser light source is controlled to perform laser treatment on the eye at the selected one or more target positions while the one or more viewing devices simultaneously display the visual display, the optical coherence tomography (OCT) image, and an indicator of the selected one or more target positions. A system.

2. The system of claim 1, further comprising an optical coherence tomography (OCT) system configured to perform optical coherence tomography (OCT) image processing during the laser treatment, wherein the processor is configured to generate an indicator of the one or more target candidate positions based on the optical coherence tomography (OCT) image processing. A system.

3. The system of claim 1, wherein the processor is configured to identify the one or more target candidate positions that are targets for laser treatment by identifying a position within the eye tissue where the density of the collecting ducts is greatest. A system.

4. The system of claim 1, wherein the processor is configured to process the optical coherence tomography (OCT) image data to identify the size of the collecting ducts within the eye tissue and identify the one or more target candidate positions that are targets for laser treatment based on the size of the collecting ducts. A system.

5. The system according to claim 1, wherein the processor is configured to identify one or more target candidate positions for laser treatment by identifying a position in the eye tissue where the collecting ducts are at a maximum number.

6. The system according to claim 1, wherein the processor processes the optical coherence tomography (OCT) image data to identify an occlusion portion of the collecting ducts in the eye tissue, and is configured to identify one or more target candidate positions for laser treatment by identifying a position in the eye tissue where the occlusion of the collecting ducts is minimal.

7. The system according to claim 1, wherein the processor processes the optical coherence tomography (OCT) image data to identify a fluid flow rate through the collecting ducts in the eye tissue, and is configured to identify one or more target candidate positions for laser treatment by identifying a position in the eye tissue where the fluid flow rate through the collecting ducts is maximum.

8. The system according to claim 1, wherein the processor is configured to identify one or more target candidate positions for laser treatment based on any combination of the density of the collecting ducts at a predetermined position in the eye tissue, the number of the collecting ducts at the predetermined position in the eye tissue, the size of the collecting ducts at the predetermined position in the eye tissue, the occlusion portion of the collecting ducts at the predetermined position in the eye tissue, and the fluid flow rate of the collecting ducts at the predetermined position in the eye tissue.

9. A method comprising: a step of an optical coherence tomography (OCT) system acquiring optical coherence tomography (OCT) image data of a living body eye tissue of a subject; a step of a processor processing the optical coherence tomography (OCT) image data to identify collecting ducts in the eye tissue; a step of the processor identifying one or more target candidate positions in the eye tissue for forming one or more openings in the eye tissue based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data; a step of the processor selecting one or more target positions from among the one or more target candidate positions; The step of the visual observation device generating a visual display of at least a part of the eye in the living body; The step of the visual observation device generating an optical coherence tomography (OCT) image of the eye tissue; The step of the visual observation device simultaneously displaying, via one or more viewing devices, an indicator of at least one of the visual display, the optical coherence tomography (OCT) image, and the selected target position; While the visual observation device performs the step of displaying, via the one or more viewing devices, an indicator of at least one of the visual display, the optical coherence tomography (OCT) image, and the selected target position, the processor transmits a control signal for applying a laser beam to at least one of the selected target positions to the laser. A method having the above.

10. In the method according to claim 9, the step of identifying the one or more target candidate positions based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data includes the step of identifying a position in the eye tissue where the density of the collecting ducts is maximum. A method.

11. In the method according to claim 9, further, The processor has a step of processing the optical coherence tomography (OCT) image data to identify the size of the collecting ducts in the eye tissue, In the method according to claim 9, the step of identifying the one or more target candidate positions based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data includes the step of identifying a position in the eye tissue where the size of the collecting ducts is maximum. A method.

12. In the method according to claim 9, the step of identifying the one or more target candidate positions based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data includes the step of identifying a position in the eye tissue where the number of the collecting ducts is maximum. A method.

13. In the method according to claim 9, further, The processor has a step of processing the optical coherence tomography (OCT) image data to identify an occlusion portion of the collecting ducts in the eye tissue, In the method according to claim 9, the step of identifying the one or more target candidate positions based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data includes the step of identifying a position in the eye tissue where the occlusion of the collecting ducts is minimal. A method.

14. The method according to claim 9, further comprising: the processor processing the optical coherence tomography (OCT) image data to identify the size of the collecting ducts in the eye tissue; the step of identifying the one or more target candidate positions based on the collecting ducts identified in the optical coherence tomography (OCT) image data includes the step of identifying the position where the fluid flow rate through the collecting ducts is maximum.

15. The method according to claim 9, wherein the step of identifying the one or more target candidate positions based on the collecting ducts identified by the step of processing the optical coherence tomography (OCT) image data includes identifying the one or more target positions based on any combination of the density of the collecting ducts at a predetermined position in the eye tissue, the number of the collecting ducts at the predetermined position in the eye tissue, the size of the collecting ducts at the predetermined position in the eye tissue, the occlusions of the collecting ducts at the predetermined position in the eye tissue, and the fluid flow rate of the collecting ducts at the predetermined position in the eye tissue.

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