Methods and systems for oct-guided glaucoma surgery
By combining OCT scanning and microscopic image enhancement techniques, the visualization challenges of Schlemm's canals and trabecular meshwork in glaucoma surgery have been solved, enabling more precise manipulation of fluid outflow structures and improving surgical outcomes and safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2018-06-18
- Publication Date
- 2026-03-27
AI Technical Summary
In current glaucoma surgeries, it is difficult to accurately target and visualize Schlemm's canal and trabecular meshwork, resulting in poor surgical outcomes. In particular, the difficulty in observation near the iridocorneal angle affects the visualization of fluid outflow structures and the precision of the surgery.
By combining structural images generated by OCT scanning with microscopic images, and using image enhancement technology to identify and guide slender probes, precise manipulation of Schlemm tubes and beam meshes can be achieved, avoiding total internal reflection interference.
It improves the accuracy and safety of glaucoma surgery, reduces the risk of accidental damage to the Schlemm tube, and enhances the visualization of fluid outflow structures and surgical outcomes.
Smart Images

Figure CN115191929B_ABST
Abstract
Description
[0001] This application is a divisional application of PCT Application No. PCT / US2018 / 038072, filed June 18, 2018, entitled "Methods and Systems for OCT-Guided Glaucoma Surgery," which entered the Chinese national phase on February 17, 2020, and has application number 201880053443.3.
[0002] CROSS REFERENCE TO RELATED APPLICATIONS
[0003] This application claims the benefit of provisional patent application U.S. Provisional Serial Application No. 62 / 521,310, filed June 16, 2017, entitled "Methods and Systems for OCT-Guided Glaucoma Surgery." This application is also related to U.S. Serial Application No. 15 / 868,904, filed January 11, 2018, entitled "Methods and Systems for OCT-Guided Glaucoma Surgery." Each of these applications is incorporated herein by reference in its entirety. TECHNICAL FIELD
[0004] Methods and systems for OCT-guided glaucoma surgery are disclosed, in which systems and methods to assist surgeons in performing surgical procedures on the eye are involved. BACKGROUND
[0005] Glaucoma is an eye disease in which structures within the eye that are vital to vision are irreversibly damaged. These structures include portions of the retina, and especially the optic nerve. Glaucoma is a treatable disease and is considered 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 angle closure glaucoma. Open angle glaucoma is the most common type of glaucoma and occurs when normally appearing outflow channels fail, causing the eye to not adequately drain fluid, resulting in elevated intraocular pressure. The elevated intraocular pressure (IOP) in most open angle glaucoma is due to outflow obstruction of aqueous humor primarily in the juxtacanalicular trabecular meshwork (TM) and the inner wall of Schlemm's canal (SC).
[0006] Treatment for elevated intraocular pressure due to outflow obstruction includes topical and systemic medications, office laser procedures, and invasive surgical risks (trabeculectomy / canaloplasty). Examples of laser procedures include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). More recently, less invasive surgical approaches have been introduced into the treatment paradigm, often referred to as minimally invasive glaucoma surgery (MIGS) or minimally invasive glaucoma surgery approaches. Current methods of IOP reduction by MIGS include increasing trabecular outflow by bypassing the juxtacanalicular trabecular meshwork (TM) and the inner wall of SC, increasing uveoscleral outflow through suprachoroidal pathways, reducing aqueous production by the ciliary body, or creating an external subconjunctival / suprachoroidal drainage pathway.
[0007] The general concept of MIGS is generally to bypass the outflow obstruction and restore flow through the eye's native outflow system, which is often intact and functioning normally outside the area of outflow obstruction, rather than creating an alternative pathway that can have significantly greater short and / or long term risks.
[0008] MIGS procedures generally involve visualizing and accessing the outflow system within the eye. Because of the shape of the cornea and the location of the intraocular structures associated with MIGS surgery in the area where the iris appears to meet the surrounding cornea, total internal reflection occurs and can prevent the surgeon from viewing those outflow structures beyond the range of "critical angle" for the optical path, which can also be referred to as the "critical angle" for the optical viewing path of the anterior chamber, in the context of the anterior chamber surgical procedures disclosed herein. According to some embodiments, the optical path disclosed herein can refer to viewing the anterior chamber angle structures, rather than the optical path of the eye's visual system, for example from the center of the cornea to the vicinity of the macula. Thus, it is generally necessary for the surgeon performing a MIGS procedure to have a device that allows visualization of those outflow structures. Direct (allowing a straight optical path to view those structures) and indirect (viewing these structures with a mirror) goniolenses can overcome total internal reflection. However, the use of goniolenses intraoperatively can require significant skill and a steep learning curve, which can limit the success of MIGS surgery by certain skilled surgeons, at least in some cases.
[0009] In at least some of these surgical procedures, a surgical opening is formed through the trabecular meshwork and the inner wall of the Schlemm's canal to enable improved fluid access to the Schlemm's canal to reduce intraocular pressure. Existing methods of accurately targeting the Schlemm's canal are generally less than ideal. Thus, methods and devices that provide improved consistency and accuracy in targeting the Schlemm's canal and other structures of the eye would be beneficial. Moreover, work related to the present disclosure suggests that at least some existing methods can result in access to the Schlemm's canal at less than ideal locations, for example at locations distal from the collector channels. Alternative MIGS devices that bypass the Schlemm's canal and drain aqueous fluid into the suprachoroidal space can also benefit from the placement of the targeting location by improving visualization of adjacent ocular structures. Examples of such implant devices include the and iStent inject® and suprachoroidal microstents. Excimer laser trabeculotomy (ELT), which creates a patent channel to the Schlemm's canal, can also benefit from improvements in targeting and visualization of the eye's structures.
[0010] In at least some cases, current methods and devices for viewing structures of the eye, such as the trabecular meshwork and scleral spur, near the iridocorneal angle can be less than ideal. For example, goniolenses can be more difficult to use than ideal, and improved methods and devices for viewing structures of the eye near the iridocorneal angle during surgery in that area would be beneficial.
[0011] In view of the above, improved methods and devices for imaging the eye during surgical procedures, targeting outflow structures of the eye, such as the Schlemm's canal, and determining target locations for openings through the trabecular meshwork and into the Schlemm's canal to improve flow would be beneficial. SUMMARY
[0012] The methods and devices disclosed herein allow for glaucoma surgery of outflow structures, including MIGS and many of its variants, without the need for a goniolens. According to one aspect of the invention, an ophthalmic surgeon can identify and operate on these outflow structures by using the structures generated by optical coherence tomography (OCT) scans, as well as virtual images and representations of surgical tools.
[0013] In one aspect, a system for assisting a physician in performing a surgical procedure on an eye is provided. The procedure includes inserting an elongated probe from an opening of the eye through the anterior chamber to a target tissue region including the trabecular meshwork and the Schlemm's canal. The system includes an optical microscope for the surgeon to view the eye with microscope images during the procedure, one or more optical coherence tomography (OCT) devices configured to perform OCT scans of one or more target locations 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 allowing viewing and in some cases superimposition of (1) one or more OCT images of the one or more target locations and / or (2) a plurality of graphical visual elements identifying the one or more target locations, wherein the plurality of graphical visual elements are aligned with the real microscope images to assist the physician in advancing a distal end of the elongated probe to the one or more target locations.
[0014] In another aspect, embodiments of the invention include a method of performing a surgical procedure on a patient's eye. An exemplary method may include viewing a live view on an observation device, wherein the live view includes (i) a microscopic view of the eye and (ii) an enhanced image having the microscopic view or a microscopic image of the eye. The enhanced image may also have 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 enables the identification of a target location located within the target tissue, wherein the actual target location is not visible in the microscopic view or microscopic image. An exemplary method may further include, while viewing the microscopic view or enhanced image on an observation device, advancing the distal end of an elongated probe toward the target tissue region within the anterior chamber of the eye, wherein the distal end of the elongated probe is initially visible in the microscopic view or microscopic image, but subsequently becomes invisible in the microscopic view or microscopic image due to total internal reflection within the eye region where the target tissue is located. Exemplary methods may also include performing surgical procedures at the actual target location using the elongated probe while the distal end of the elongated probe is not visible in a microscope view or microscope image, and while obtaining information about the relative position of the distal end of the elongated probe relative to the target location from an enhanced image.
[0015] According to some embodiments, graphic visual elements identifying the target location may overlay a microscope view or microscope image. In some embodiments, the real-time view includes an enhanced image of a microscope view with the eye, an OCT image aligned with the microscope view, and the actual target location is not visible in the microscope view. Graphic visual elements may overlay the microscope view. In some embodiments, the advancement step includes advancing the distal end of an elongated probe toward the target tissue region within the anterior chamber of the eye while viewing the enhanced image on an observation device, wherein the distal end of the elongated probe is initially visible in the microscope view but subsequently becomes invisible in the microscope view due to total internal reflection within the eye region where the target tissue region is located. In some embodiments, the execution step includes performing a surgical procedure at the target location using the elongated probe while the distal end of the elongated probe is invisible in the microscope view and while obtaining information about the relative position of the distal end of the elongated probe relative to the target location from the microscope view. In some embodiments, the real-time view includes the enhanced image, and the OCT image aligned with the microscope view or microscope image includes information about the Schlemm tube and collecting canal system. In some embodiments, the real-time view includes the enhanced image, and the OCT image aligned with the microscope view or microscope image includes information about the relative position of the distal end of the elongated probe relative to the target location.
[0016] In some cases, a graphical visual element corresponding to the distal end of the elongated probe is overlaid on the microscope view or microscope image, and the advancing step includes advancing the distal end of the elongated probe toward the target tissue region while viewing the graphical visual element corresponding to the distal end of the elongated probe and the graphical visual element corresponding to the target location on the augmented image. In some embodiments, a graphical visual element corresponding to the distal end of the elongated probe and a graphical 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 contact exists between the distal end of the elongated probe and the surface of the trabecular meshwork when the graphical visual element corresponding to the distal end of the elongated probe and the graphical visual element corresponding to the surface of the trabecular meshwork are sufficiently close. In some embodiments, a graphical visual element corresponding to the surface of the trabecular meshwork and a graphical visual element corresponding to the juxtacanalicular meshwork of the eye 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 graphical visual element corresponding to the surface of the trabecular meshwork and the graphical visual element corresponding to the juxtacanalicular meshwork are sufficiently close. In some embodiments, a graphical visual element corresponding to the inner wall of the Schlemm 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 canal has been penetrated when the graphical visual element corresponding to the inner wall of the Schlemm canal has disappeared from the microscope view or microscope image.
[0017] In some cases, a guide arrow is overlaid on the microscope view or microscope image, and the guide arrow is pointed toward the graphical visual element identifying the target location. In some cases, a guide arrow is overlaid on the microscope view or microscope image, and the guide arrow is pointed toward the graphical visual element identifying the target location. In some methods, the advancing step includes advancing the distal end of the elongated probe toward the target location while using the guide arrow as a guide. In certain methods, the performing step includes ablating the target location with a laser pulse emitted by the elongated probe, and a second guide arrow is overlaid on the microscope view or microscope image after a channel connecting the anterior chamber to a lumen of the Schlemm canal is formed at the target location, where the second guide arrow is pointed toward a second graphical visual element identifying a second target location of the eye, and the method can further include advancing the distal end of the elongated probe toward the second target location while using the second guide arrow as a guide. The method can further include ablating the second target location with the elongated probe.
[0018] In some embodiments, the viewing device can be a display device, a microscope device, a heads-up display, a viewing monitor, a virtual reality viewing device, or an augmented reality viewing device. In some embodiments, the graphical visual element identifying the distal end of the elongated probe can overlay a microscope view or a microscope image, and the relative position of the distal end of the elongated probe relative to the target location can be based on the relative position of the distal end of the elongated probe relative to the graphical visual element identifying the target location. In some cases, the actual target location is not visible in the microscope view or microscope image due to total internal reflection within the eye. In some cases, the target location is determined based on a pre-operative optical coherence tomography (OCT) image, an intra-operative optical coherence tomography (OCT) image, a pre-operative optical coherence tomography (OCT) image and an intra-operative optical coherence tomography (OCT) image, or is decided by the surgeon. In some cases, the pre-operative OCT image shows a network of Schlemm’s canal and the collector channels of the eye, and the target location is determined based on the pre-operative OCT image. In some cases, the target location is determined from a microscope-based OCT image, a fiber-based OCT image, or a microscope-based OCT image and a fiber-based OCT image.
[0019] In yet another aspect, embodiments of the present application include a method of assisting a surgeon in performing a surgical procedure on an eye of a patient. In such a procedure, the surgeon can use an elongated probe having a distal end. An exemplary method includes providing a real-time view to the surgeon. The real-time view can 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 can further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image can be aligned with the microscope view or the microscope image. The OCT image can enable identification of a target location located in the target tissue region. The actual target location can not be visible in the microscope view or the microscope image. The augmented image can enable the surgeon to perceive information about the relative position of the distal end of the elongated probe relative to the target location when the distal end of the elongated probe is not visible in the microscope view or the microscope image.
[0020] In some cases, the graphical visual element identifying the target location can overlay the microscope view or the microscope image. In some cases, the real-time view includes an augmented image of the microscope view with the eye, the OCT image is aligned with the microscope view, the actual target location is not visible in the microscope view, and the augmented image enables the surgeon to perceive information about the relative position of the distal end of the elongated probe relative to the target location when the distal end of the elongated probe is not visible in the microscope view. The graphical visual element can overlay the microscope view. According to some embodiments, the real-time view includes an augmented image of the microscope image with the eye, the OCT image is aligned with the microscope image, the actual target location is not visible in the microscope image, and the augmented image enables the surgeon to perceive information about the relative position of the distal end of the elongated probe relative to the target location when the distal end of the elongated probe is not visible in the microscope image. The graphical visual element can overlay the microscope image.
[0021] According to some embodiments, the real-time view includes the augmented image and the OCT image aligned with the microscope view or the microscope image includes information about the Schlemm canal and the collector channel system. According to some embodiments, the real-time view includes the augmented image and the OCT image aligned with the microscope view or the microscope image includes information about the relative position of the distal end of the elongated probe relative to the target location. In some cases, a graphical visual element corresponding to the distal end of the elongated probe is overlaid on the microscope view or the microscope image, and information about the relative position of the distal end of the elongated probe relative to the target location is provided by the graphical visual element corresponding to the distal end of the elongated probe and the graphical visual element corresponding to the target location. In some cases, a graphical visual element corresponding to the distal end of the elongated probe and a graphical visual element corresponding to the surface of the trabecular meshwork of the eye are overlaid on the microscope view or the microscope image, and the augmented image enables the surgeon to determine whether there is contact between the distal end of the elongated probe and the surface of the trabecular meshwork based on the relative positions of the graphical visual element corresponding to the distal end of the elongated probe and the graphical visual element corresponding to the surface of the trabecular meshwork. In some cases, a graphical visual element corresponding to the surface of the trabecular meshwork and a graphical visual element corresponding to the juxtacanalicular meshwork of the eye are overlaid on the microscope view or the microscope image, and the augmented image enables the surgeon to determine whether the trabecular meshwork of the eye is sufficiently compressed based on the relative positions of the graphical visual element corresponding to the surface of the trabecular meshwork and the graphical visual element corresponding to the juxtacanalicular meshwork. In some cases, a graphical visual element corresponding to the inner wall of the Schlemm canal of the eye is overlaid on the microscope view or the microscope image, and the augmented image enables the surgeon to determine whether the inner wall of the Schlemm canal has been penetrated based on whether the graphical visual element corresponding to the inner wall of the Schlemm canal is present or absent in the microscope view or the microscope image.
[0022] According to some embodiments, a guide arrow is overlaid on the microscope view or microscope image and the guide arrow points to a graphical visual element identifying the target location. According to some embodiments, a guide arrow is overlaid on the microscope view or microscope image, the guide arrow points to a graphical visual element identifying the target location, and after ablating the target location, a second guide arrow is overlaid on the microscope view or microscope image and the second guide arrow points to a second graphical visual element identifying a second target location of the eye. In some cases, the real-time view is provided to the surgeon by a display device, a microscope device, a heads-up display, a viewing monitor, a virtual reality viewing device, or an augmented reality viewing device. In some cases, a graphical visual element identifying a distal end of the elongated probe is overlaid on the microscope view or microscope image and the relative position of the distal end of the elongated probe relative to the target location is based on identifying the relative position of the distal end of the elongated probe relative to the graphical visual element identifying the target location. In certain cases, the actual target location is not visible in the microscope view or microscope image due to total internal reflection within the eye. In certain cases, the target location 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 is decided by the surgeon. In certain cases, the preoperative OCT image displays a network of Schlemm’s canal and the collector channels of the eye and the target location is determined based on the preoperative OCT image.
[0023] According to some embodiments, the target location can be determined from a microscope-based OCT image, a fiber-based OCT image, or a microscope-based OCT image and a fiber-based OCT image. In some cases, the method can further include providing a notification to the surgeon upon detecting that the trabecular meshwork of the eye is sufficiently stressed, where the sufficient stress is detected based on the relative positions of a graphical visual element corresponding to the surface of the trabecular meshwork and a graphical visual element corresponding to the juxtacanalicular meshwork. In some cases, the method can further include automatically initiating delivery of laser ablation energy to the actual target location upon detecting that the trabecular meshwork of the eye is sufficiently stressed. In certain cases, the method can include providing a notification to the surgeon upon detecting that the inner wall of Schlemm’s canal is penetrated, where the inner wall penetration of Schlemm’s canal is detected by the elongated probe and displayed in the real-time view based on whether a graphical visual element corresponding to the inner wall of Schlemm’s canal is present in the augmented image. In certain cases, the method can include automatically terminating delivery of laser ablation energy to the actual target location upon detecting that the inner wall of Schlemm’s canal is penetrated.
[0024] In another aspect, embodiments of the present application include a computer program product for assisting a surgeon in performing a surgical procedure on an eye of a patient, e.g., where the surgeon uses an elongated probe having a distal end. The computer program product can be embodied on a non-transitory, tangible computer readable medium. An example computer program product includes computer executable code for generating a real-time view for viewing by the surgeon, where the real-time view includes (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 can further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image can be aligned with the microscope view or the microscope image. The OCT image can enable identification of a target location located in the target tissue region. The actual target location can not be visible in the microscope view or the microscope image. The augmented image can enable the surgeon to perceive information about a relative position of the distal end of the elongated probe with respect to the target location when the distal end of the elongated probe is not visible in the microscope view or the microscope image. In some cases, a graphical visual element identifying the target location located in the target tissue region overlays the microscope view or the microscope image. According to some embodiments, the real-time view includes an augmented image having 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 augmented image enables the surgeon to perceive information about a relative position of the distal end of the elongated probe with respect to the target location when the distal end of the elongated probe is not visible in the microscope view. The graphical visual element can overlay the microscope view. According to some embodiments, the real-time view includes an augmented image having 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 augmented image enables the surgeon to perceive information about a relative position of the distal end of the elongated probe with respect to the target location when the distal end of the elongated probe is not visible in the microscope image. The graphical visual element can overlay the microscope image.
[0025] In some cases, the real-time view includes the augmented image, and the OCT image aligned with the microscope view or microscope image includes information about the Schlemm canal and the collector channel system. In certain cases, the real-time view includes the augmented image, and the OCT image aligned with the microscope view or microscope image includes information about the relative position of the distal end of the elongated probe relative to the target location. In some cases, a graphical visual element corresponding to the distal end of the elongated probe is overlaid on the microscope view or microscope image, and information about the relative position of the distal end of the elongated probe relative to the target location is provided by the graphical visual element corresponding to the distal end of the elongated probe and a graphical visual element corresponding to the target location. In some cases, a graphical visual element corresponding to the distal end of the elongated probe and a graphical visual element corresponding to the surface of the trabecular meshwork of the eye are overlaid on the microscope view or microscope image, and the augmented image enables the surgeon to determine whether contact exists between the distal end of the elongated probe and the surface of the trabecular meshwork based on the relative positions of the graphical visual element corresponding to the distal end of the elongated probe and the graphical visual element corresponding to the surface of the trabecular meshwork. In some cases, a graphical visual element corresponding to the surface of the trabecular meshwork and a graphical visual element corresponding to the juxtacanalicular meshwork of the eye are overlaid on the microscope view or microscope image, and the augmented image enables the surgeon to determine whether the trabecular meshwork of the eye is sufficiently compressed based on the relative positions of the graphical visual element corresponding to the surface of the trabecular meshwork and the graphical visual element corresponding to the juxtacanalicular meshwork. In some cases, a graphical visual element corresponding to the inner wall of the Schlemm canal of the eye is overlaid on the microscope view or microscope image, and the augmented image enables the surgeon to determine whether the inner wall of the Schlemm canal has been penetrated based on whether the graphical visual element corresponding to the inner wall of the Schlemm canal is present or absent in the microscope view or microscope image.
[0026] According to some embodiments, a guide arrow can be overlaid on the microscope view or microscope image, and the guide arrow can point to a graphical visual element identifying the target location. In some embodiments, a guide arrow can be overlaid on the microscope view or microscope image, the guide arrow can point to a graphical visual element identifying the target location, and after ablating the target location, a second guide arrow can be overlaid on the microscope view or microscope image, and the second guide arrow can point to a second graphical visual element identifying a second target location of the eye. In some cases, the real-time view can be provided to the surgeon through a display device, a microscope device, a heads-up display, a viewing monitor, a virtual reality viewing device, or an augmented reality viewing device. In some cases, a graphical visual element identifying a distal end of the elongated probe can be overlaid on the microscope view or microscope image, and the relative position of the distal end of the elongated probe relative to the target location is based on identifying the relative position of the distal end of the elongated probe relative to the graphical visual element identifying the target location. In certain cases, the actual target location can not be visible in the microscope view or microscope image due to total internal reflection within the eye.
[0027] According to some embodiments, the target location can be determined based on a preoperative optical coherence tomography (OCT) image, an intraoperative optical coherence tomography (OCT) image, or a preoperative optical coherence tomography (OCT) image and an intraoperative optical coherence tomography (OCT) image. In certain cases, the preoperative OCT image can show a network of Schlemm’s canal and the collector channels of the eye, and the target location can be determined based on the preoperative OCT image. In certain cases, the target location can be determined from a microscope-based OCT image, a fiber-based OCT image, a microscope-based OCT image and a fiber-based OCT image, or by the surgeon’s discretion. The computer program product can further include computer executable code for providing a notification to the surgeon upon detecting that the trabecular meshwork of the eye is sufficiently stressed, wherein the sufficient stress is detected based on the relative positions of a graphical visual element corresponding to the surface of the trabecular meshwork and a graphical visual element corresponding to the juxtacanalicular meshwork. In certain cases, the computer program product can also include computer executable code for automatically initiating delivery of laser ablation energy to the actual target location upon detecting that the trabecular meshwork of the eye is sufficiently stressed. In certain cases, the computer program product can also include computer executable code for providing a notification to the surgeon upon detecting that the inner wall of Schlemm’s canal is penetrated, wherein the inner wall of Schlemm’s canal is penetrated by the elongated probe and displayed in the real-time view based on whether a graphical visual element corresponding to the inner wall of Schlemm’s canal is present in the augmented image. In certain cases, the computer program product can also include computer executable code for automatically terminating delivery of laser ablation energy to the actual target location upon detecting that the inner wall of Schlemm’s canal is penetrated.
[0028] In another aspect, embodiments of the present application include a method of performing a surgical procedure on an eye of a patient, where the example method includes viewing a real-time view on a viewing device, where the real-time view includes an augmented image having a microscope view or microscope image of the eye. The augmented image can further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image can include information about the Schlemm's canal and collector system, and can be aligned with the microscope view or microscope image. In some cases, a graphical visual element identifying a target location located in the target tissue region can overlay the microscope view or microscope image. The actual target location can not be visible in the microscope view or microscope image. The example method can also include advancing a distal end of an elongated probe toward the target tissue region within an anterior chamber of the eye while viewing the augmented image on the viewing device, where the distal end of the elongated probe is initially visible in the microscope view or microscope image, and thereafter becomes invisible in the microscope view or microscope image due to total internal reflection within the region of the eye where the target tissue is located. The example method can further include performing the surgical procedure at the actual target location using the elongated probe while the distal end of the elongated probe is invisible in the microscope view or microscope image, and while obtaining information from the augmented image about a relative position of the distal end of the elongated probe relative to the target location.
[0029] In another aspect, embodiments of the present application include a method of performing a surgical procedure on an eye of a patient, where the example method includes viewing a real-time view on a viewing device, where the real-time view includes an augmented image having a microscope view or microscope image of the eye. The augmented image can further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image can include information about the Schlemm's canal and collector system, and can be aligned with the microscope view or microscope image. In some cases, a graphical visual element identifying a target location located in the target tissue region can overlay the microscope view or microscope image. The actual target location can not be visible in the microscope view or microscope image. The example method can also include advancing a distal end of an elongated probe toward the target tissue region within an anterior chamber of the eye while viewing the augmented image on the viewing device, where the distal end of the elongated probe is initially visible in the microscope view or microscope image, and thereafter becomes invisible in the microscope view or microscope image due to total internal reflection within the region of the eye where the target tissue is located. The example method can further include performing the surgical procedure at the actual target location using the elongated probe while the distal end of the elongated probe is invisible in the microscope view or microscope image, and while obtaining information from the augmented image about a relative position of the distal end of the elongated probe relative to the target location.
[0030] In yet another aspect, embodiments of the present application include a computer system to assist a surgeon in performing a surgical procedure on an eye of a patient. During the surgical procedure, the surgeon can use an elongated probe having a distal end. An example computer system can include a processor, an electronic storage operatively coupled with the processor, and processor-executable code stored on the electronic storage and embodied in a tangible, non-transitory computer- readable medium. The processor-executable code, when executed by the processor, can cause the processor to generate a real-time view for the surgeon to view. The real-time view can 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 can further include an optical coherence tomography (OCT) image of a target tissue region. The OCT image can be aligned with the microscope view or the microscope image. The actual target location can not be visible in the microscope view or the microscope image. When the distal end of the elongated probe is not visible in the microscope view or the microscope image, the augmented image can enable the surgeon to perceive information about the relative position of the distal end of the elongated probe relative to the target location. In some cases, a graphical visual element identifying the target location located in the target tissue region can overlay the microscope view or the microscope image.
[0031] In yet another aspect, embodiments of the present application include a fiber-based device for performing a surgical procedure in a target tissue region located beyond the critical angle of a patient's eye. An exemplary fiber-based device can include a sheath and one or more optical fibers encapsulated by the sheath. The one or more optical fibers can be configured to (i) transmit optical energy sufficient to photoablate the target tissue region and (ii) perform optical coherence tomography (OCT) imaging of the eye. The fiber-based device can be configured to perform OCT imaging of the target tissue region along a longitudinal axis of the probe. In some cases, the target tissue region includes the trabecular meshwork, the juxtacanalicular meshwork, the inner wall of the Schlemm's canal, and the Schlemm's canal. In some cases, the fiber-based device is configured to transmit optical energy sufficient to photoablate the target tissue region when the OCT scan indicates that the trabecular meshwork of the target tissue region is sufficiently stressed. In some cases, the fiber-based device is configured to automatically stop transmission of the optical energy when the 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 automatically stop transmission of the optical energy when the 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 the surgeon to stop transmission of the optical energy when the 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 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 can be displayed to enable the surgeon to operate in the target tissue region.
[0032] In another aspect, embodiments of the present application include a microscope-based optical coherence tomography (OCT) device for facilitating a surgical procedure in a target tissue region located beyond the critical angle of a patient's eye. An exemplary microscope-based OCT device can include an OCT unit configured to (i) detect a probe disposed in 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 certain cases, the target tissue region includes the trabecular meshwork, the juxtacanalicular meshwork, the inner wall of the Schlemm's canal, and the Schlemm's canal. In some cases, the microscope-based OCT device is configured to detect a fiber-based device. In some cases, the fiber-based device is configured to transmit optical energy sufficient to photoablate the target tissue region when the microscope-based OCT scan indicates that the trabecular meshwork of the target tissue region is sufficiently stressed. In certain cases, the fiber-based device is configured to automatically stop the transmission of optical energy when the microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In certain cases, the fiber-based device is configured to automatically stop the transmission of optical energy when the microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In certain cases, the fiber-based device is configured to notify the surgeon to stop the transmission of optical energy when the microscope-based OCT scan indicates that the inner wall of the Schlemm's canal has been penetrated. In certain cases, the fiber-based device is configured to be detected by the microscope-based OCT device, and information processed by both the fiber-based device and the microscope-based OCT device can be displayed to enable the surgeon to operate in the target tissue region.
[0033] In yet another aspect, embodiments of the present application 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 can be performed by a surgeon in a target tissue region that is located outside of a critical angle of an eye of a patient. An exemplary computer program product can include computer executable code for instructing the microscope-based OCT device to perform OCT imaging of the target tissue region, and computer executable code for instructing the fiber-based device to perform OCT imaging of the target tissue region along a longitudinal axis of a probe controlled by the surgeon. In some cases, the target tissue region includes the trabecular meshwork, the juxtacanalicular meshwork, the inner wall of Schlemm's canal, and Schlemm's canal. In some cases, the computer program product can further include computer executable code for instructing the fiber-based device to transmit light energy sufficient to photoablate the target tissue region when the OCT scans performed by the fiber-based device indicate that the trabecular meshwork of the target tissue region is sufficiently stressed. In some cases, the computer program product can further include computer executable code for enabling the fiber-based device to transmit light energy sufficient to photoablate the target tissue region when the OCT scans performed by the microscope-based OCT device indicate that the trabecular meshwork of the target tissue region is sufficiently stressed. In some cases, the computer program product can further include computer executable code for enabling the fiber-based device to transmit light energy sufficient to photoablate the target tissue region in conjunction with the microscope-based OCT device when the OCT scans performed by the fiber-based device in conjunction with the microscope-based OCT device indicate that the trabecular meshwork of the target tissue region is sufficiently stressed. In some cases, the computer program product can further include computer executable code for automatically stopping the transmission of light energy when the OCT scans performed by the fiber-based device indicate that the inner wall of Schlemm's canal has been penetrated. In some cases, the computer program product can further include computer executable code for automatically stopping the transmission of light energy when the OCT scans performed by the microscope-based OCT device indicate that the inner wall of Schlemm's canal has been penetrated. In some cases, the computer program product can further include computer executable code for automatically stopping the transmission of light energy when the OCT scans performed by the fiber-based device in conjunction with the microscope-based OCT device indicate that the inner wall of Schlemm's canal has been penetrated. In some cases, the computer program product can further include computer executable code for notifying the surgeon to stop the transmission of light energy when the OCT scans performed by the fiber-based device indicate that the inner wall of Schlemm's canal has been penetrated. In some cases, the computer program product can further include computer executable code for notifying the surgeon to stop the transmission of light energy when the OCT scans performed by the microscope-based OCT device indicate that the inner wall of Schlemm's canal has been penetrated.In certain instances, the computer program product can further include computer executable code for notifying the surgeon to stop the transmission of light energy when the OCT scans performed by the fiber-based device in conjunction with the microscope-based OCT device indicate that the inner wall of the Schlemm canal has been penetrated. In certain instances, the computer program product can further include computer executable code for instructing the microscope-based OCT device to detect the fiber-based device. In certain instances, the fiber-based device can be configured to be detected by the microscope-based OCT device and information processed by both the fiber-based device and the microscope-based OCT device can be displayed to enable the surgeon to operate in the target tissue region.
[0034] In another aspect, embodiments of the present application include a method of treatment comprising viewing an enhanced image on a viewing device, wherein the enhanced image has a microscope view or microscope image of an eye, and wherein the enhanced image further has an optical coherence tomography (OCT) image of a target tissue region. The OCT image can be aligned with the microscope view or microscope image. The OCT image can enable identification of a target location located in the target tissue region, and the target location can not be visible in the microscope view or microscope image. Related methods can include advancing a distal end of an elongated probe toward the target tissue region within an anterior chamber of the eye while viewing the microscope view or the enhanced image on the viewing device, wherein the distal end of the elongated probe is initially visible in the microscope view or microscope image, and thereafter becomes invisible in the microscope view or microscope image due to total internal reflection in the eye. Related methods can further include performing a surgical procedure at the target location using the elongated probe while the distal end of the elongated probe is invisible in the microscope view or microscope image, and while obtaining information from the enhanced image regarding a relative position of the distal end of the elongated probe relative to the target location.
[0035] INCORPORATED BY REFERENCE
[0036] All publications, patents, patent applications, journal articles, books, technical references, and the like mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference, and the like was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF DRAWINGS
[0037] The novel features of the application are set forth with particularity in the appended claims. A better understanding of the features and advantages of the systems and methods provided herein can be obtained by reference to the following detailed description that sets forth illustrative embodiments, which are described in connection with the following drawings, in which:
[0038] Figure 1 is a schematic cross-sectional view of an eye showing anatomical structures;
[0039] Figure 2 is a partial perspective view of anatomical structures adjacent to the anterior chamber of an eye, depicting the corneo-scleral angle and flow of aqueous fluid;
[0040] Figure 3 is a schematic cross-sectional view of an eye showing a fiber optic probe traversing the anterior chamber from a limbal puncture point toward the trabecular meshwork in the anterior chamber of the eye.
[0041] Figure 4 and Figure 5 schematically illustrates a system for assisting a physician in performing a surgical procedure on an eye according to embodiments of the present application;
[0042] Figure 6 shows real images of an eye and a fiber optic probe and exemplary augmented (virtual) images and augmented (virtual) views;
[0043] Figure 6A depicts aspects of a patient's eye and optical equipment according to embodiments of the present application.
[0044] Figure 6B -C shows aspects of an augmented view or image according to embodiments of the present application.
[0045] Figures 7A-7F shows exemplary real and augmented / virtual images viewed by a surgeon or user during a surgical procedure;
[0046] Figure 8 shows an exemplary system according to fiber-based OCT according to embodiments of the present application;
[0047] Figure 9 shows exemplary augmented (virtual) images and augmented (virtual) views obtained using the system in Figure 8 ;
[0048] Figure 10 shows an exemplary system according to microscope-based OCT according to embodiments of the present application;
[0049] Figure 11 schematically illustrates an example of an OCT guidance system 1100 according to embodiments of the present application;
[0050] Figure 12A -D shows an example of an instrument that can be used in conjunction with the provided system;
[0051] Figure 13 shows a flowchart of a method for determining a target location and a probe location according to embodiments;
[0052] Figure 13A- B depicts aspects of treatment and assistive methods, respectively, in accordance with embodiments of the application.
[0053] Figure 14 An analysis and control system that can be configured to implement any of the analysis and control systems disclosed in the present application is shown; and
[0054] Figure 15 Examples of pre-operative OCT images and enhanced pre-operative OCT images showing the collector and target locations are shown. DETAILED DESCRIPTION
[0055] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments can be utilized, and other changes can be made, without departing from the scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and with reference to the attached drawings, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
[0056] The methods and devices are well suited for use in combination with a variety of alternative MIGS methods for treating glaucoma, such as iStent Inject, and others. Although reference is made to treatments without goniolenses in some embodiments, the methods and devices disclosed herein are also well suited for use in combination with goniolenses.
[0057] The methods and systems disclosed herein can allow a greater number of ophthalmic surgeons to successfully perform MIGS procedures. For example, the disclosed methods and devices can allow surgical openings to be formed more uniformly and consistently to enable, for example, aqueous fluid to flow out of the anterior chamber of the eye into the Schlemm's canal with improved outflow. Additionally, the disclosed systems and methods can improve the effectiveness of the procedure by allowing the surgeon to identify a target location for the Schlemm's canal opening to increase outflow. In some cases, the target location can include a surface or layer of tissue, or a location in the tissue, such as the inner wall of the trabecular meshwork, the juxtacanalicular trabecular meshwork (JCTM), the outer wall of the Schlemm's canal, the sclera, or a desired combination thereof.
[0058] The presently disclosed methods and apparatuses can include a combination of surgical microscope images with sensing devices that enable a surgeon to simultaneously view live head-up display images. These live images can enable a surgeon to target and treat locations within the eye that can not be easily visualized using a surgical microscope alone, including structures such as the trabecular meshwork and Schlemm’s canal. The methods and apparatuses disclosed herein can allow a surgeon to view angular structures that are obscured or blocked by total internal reflection. For example, the disclosed methods and apparatuses can allow the collection of images or information of structures that are otherwise poorly or not visible, such as the collector system, using OCT optical coherence tomography (OCT) technology. A surgeon can be able to identify and target a preferred surgical site by viewing a real image of the eye and superimposed projected images of ocular structures simultaneously with images of those structures, such as OCT images of the collector system obtained earlier in alignment with visible markers. In this way, the images viewed by the surgeon include real (optical) and projected (virtual) images combined to enhance surgical targeting. Other information can also be provided to the surgeon / observer, such as virtual images of otherwise invisible structures and one or more symbols to indicate distance and motion, such as from a probe tip to the trabecular meshwork to Schlemm’s canal. In some embodiments, OCT imaging can be used to identify the collectors of the eye and enable a surgeon to identify sites by these target locations, such as by using graphical visual elements such as treatment reference markers to identify target locations, which are shown to the user to assist in creating openings at appropriate locations in the trabecular meshwork of the eye to increase flow. Embodiments of the present invention include any of a variety of OCT scan patterns or maps, including preoperative and / or intraoperative OCT maps or images of outflow systems (e.g., Schlemm’s canal and collector channels), such as depicted in Figure 15 which can be overlaid on a microscope image or view. In some cases, one or more OCT images can be used to generate virtual images of angular structures, such as shown in image 610 of Figure 6 In some cases, such as shown in feature 620 of Figure 6 one or more OCT images can be used to generate graphical depictions of the relationship between various structures and surgical instruments (e.g., fibers / probes).
[0059] Such displays can be coupled to a surgical microscope to present monocular or binocular virtual images from the display that are visually combined with, for example, binocular real optical images of an eye. The methods and apparatuses disclosed herein are well suited for use in ELT surgery and implant device surgery that utilize openings that provide drainage of fluid from the eye. However, the systems and methods provided can also be applied to a variety of other surgical procedures that can utilize fiber-based OCT, such as any and all surgeries using endoscopes.
[0060] While specifically relating to the use of laser-assisted trabeculectomy (ELT) for glaucoma treatment, the methods and systems disclosed herein can be used for many other types of surgery. For example, the embodiments disclosed herein can be used with other surgical procedures, including endoscopic surgeries related to orthopedic surgery, neurosurgery, neurology, otolaryngology (ENT), abdominal, thoracic, cardiovascular, endocardial, and other applications. The currently disclosed methods and apparatus can utilize OCT to improve aiming accuracy and provide virtual visualization, enabling surgeons to perform procedures in areas that are not easily visualized by microscopes or endoscopes. Such applications include any endoscopic procedure that enhances virtual visualization to realistic images to aid surgical accuracy in 3D space, one example being endovascular procedures involving tortuous or curved vessels. Certain aspects can also be used to treat and modify other organs, such as the brain, heart, lungs, intestines, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, soft tissues such as bone marrow, adipose tissue, muscles, glands and mucous membranes, spinal and nerve tissues, cartilage, hard biological tissues (e.g., teeth, bones), and body cavities and passages such as sinuses, ureters, colon, esophagus, lung passages, blood vessels, and throat. For example, the devices disclosed herein can be inserted through existing body cavities or through openings formed in body tissues.
[0061] 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.
[0062] To understand the described embodiments, a brief overview of the anatomical structure of the eye E is provided. For example... Figure 1 As schematically shown, 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 constantly flowing transparent fluid called aqueous humor 1. The lens 4 is supported by fibrous bands attached to the ciliary body 20 and moves within the eye. The iris 19, circumferentially attached to the scleral process, includes the central pupil 5. The diameter of the pupil 5 controls the amount of light passing through the lens 4 to reach the retina 8. The posterior chamber 2 is located between the iris 19 and the ciliary body 20.
[0063] As shown in FIG. 2, the anatomy of the eye also includes the trabecular meshwork (TM) 9, which is a triangular band of spongy tissue located within the eye before the iris 19 inserts into the scleral spur. The shape of the movable trabecular meshwork varies and is small in size. It is generally triangular in cross-section, with a thickness that varies from about 100-200 pm. It is composed of different layers of fibers with micron-sized pores that form fluid pathways for aqueous humor to flow out of the anterior chamber. The trabecular meshwork 9 has been measured at its anterior edge, the Schwalbe’s line 18, to be about 100 pm in thickness at the junction of the cornea 15 and the sclera 17.
[0064] The base of the trabecular meshwork widens to about 200 pm, where it and the iris 19 attach to the scleral spur. The height of the trabecular meshwork can be about 400 pm. The passageway through the pores in the trabecular meshwork 9 passes through very thin, porous tissue called the juxtacanalicular trabecular meshwork 13, which in turn abuts the inner wall of the vascular structure, Schlemm’s canal 11. The height of the Schlemm’s canal can be about 200 pm, 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 connects to a series of collector channels (CC) 12, which drain the aqueous humor into the venous system. Because the aqueous humor 1 is constantly produced by the ciliary body and flows into the anterior chamber through the pupil, any obstruction in the trabecular meshwork, juxtacanalicular trabecular meshwork, or Schlemm’s canal can prevent the aqueous humor from easily escaping from the anterior chamber of the eye. Since the eye is essentially a closed sphere, this results in an increase in intraocular pressure within the eye. The increase in intraocular pressure can cause damage to the retina and optic nerve, ultimately leading to blindness.
[0065] The obstruction of the outflow of aqueous humor that occurs in most open-angle glaucoma, i.e., glaucoma characterized by easily observable trabecular meshwork with gonioscopy, is typically located in the area of the juxtacanalicular trabecular meshwork (JCTM) 13, between the trabecular meshwork 9 and the Schlemm’s canal 11, more specifically the inner wall of the Schlemm’s canal.
[0066] When an obstruction forms, for example, at the juxtacanalicular trabecular meshwork 13, the intraocular pressure gradually increases over time. Thus, 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 effective methods of reducing and controlling intraocular pressure are being sought. Generally, various drug therapies have been employed to control intraocular pressure. Although these treatment methods can be effective for a period of time, the intraocular pressure of many patients generally continues to increase. However, patients often do not follow prescribed treatment regimens. As a result, inadequate control of glaucoma increases the risk of irreversible damage to the optic nerve and ultimately loss of vision.
[0067] Figure 3This is a side-view cross-sectional view of the internal anatomy of the human eye E, showing the fiber optic probe 23 in relation to an embodiment of a method for treating glaucoma. Following the application of local, periocular, and / or retroocular anesthesia, a small, self-sealing puncture incision 14 is formed in the cornea 15. The anterior chamber can be stabilized using a fluid-flow chamber retainer or a viscoelastic agent. The fiber optic probe 23 can then be positioned and inserted through the incision 14 into the anterior chamber 7 until the distal end of the fiber optic probe 23 contacts and slightly compresses the desired target TM tissue.
[0068] laser unit 31 ( Figure 4 The photoablation laser energy generated (as shown) is transmitted from the distal end of the fiber optic probe 23 to contact the tissue to be ablated. The tissue to be ablated may include the trabecular mesh 9, the peritrabecular mesh 13, and the inner wall of the Schlemm tube 11. A hole in the proximal inner wall of the Schlemm tube 11 is formed in a manner that does not perforate the distal outer wall of the Schlemm tube. In some embodiments, additional holes are created in the target tissue. Thus, the creation of one or more holes effectively restores the relatively normal rate of aqueous humor outflow.
[0069] The fiber optic probe 23 may include one or more optical fibers encapsulated in a sheath. The diameter of a single fiber should be large enough to transmit sufficient optical energy to effectively cause photoablation of the target tissue and, in some embodiments, enable OCT imaging of the target tissue. In some embodiments, the fiber diameter is in the range of about 4-6 μm. A single fiber or multiple fibers may be used in bundles, for example, with diameters ranging from about 100 μm to about 1000 μm. The core and sheath may be encapsulated in an external metal sleeve or shielding layer. In some embodiments, the sleeve is made of stainless steel. In some embodiments, the outer diameter of the sleeve is less than about 100 μm. In some embodiments, the diameter can be as small as 100 μm because smaller fibers are implemented using a laser transmission system. In some cases, the fiber diameter can be about 200 μm and the fiber optic probe 23 can have a larger diameter, such as 500 μm, to encapsulate one or more fibers. In some embodiments, the sleeve may be flexible, allowing it to bend or angled.
[0070] Figure 4 and Figure 5A system 400 for assisting a physician in performing a surgical procedure on an eye E according to embodiments of the present application is schematically illustrated. The surgical procedure can include inserting an elongate probe 23 from an opening of the eye through the anterior chamber to a target tissue region including the trabecular meshwork and Schlemm's canal. In some embodiments, the system 400 can include an optical microscope 409 for the surgeon to view the eye in real-time during the procedure. Integrated in the optical microscope 409 can be an optical coherence tomography (OCT) device. The microscope can include, for example, a surgical microscope. The system 400 can include an OCT unit 401 configured to perform OCT scans on one or more target locations in the target tissue region during the procedure. For example, the OCT unit 401 described herein can include a microscope OCT 403 or a fiber optic OCT 402 and combinations thereof. The images captured by the OCT unit 403 or 402 can be processed by an image processing device 412 of the control unit 410 to generate a plurality of augmented images that are visualized in real-time by the physician. The augmented images can be displayed on a display of a heads-up display 407 and combined with optical images from the microscope with an internal beam splitter to form a monocular or binocular image, as known to those of ordinary skill in the art. As discussed elsewhere herein, the microscope view can 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 can be aligned with the "real" image using an alignment-enabled element. According to some embodiments, the surgeon can first view the "real" image of the surgical instrument, such as a probe, in the microscope or a video image from the microscope. In some cases, the surgeon can observe the augmented image or view. If the OCT is overlaid on the "real" image, the surgeon can observe the "real" image and the overlaid OCT image simultaneously. The augmented images can be presented to the physician through the eyepiece (or eyepieces) of the microscope or the eyepiece and / or the display of the microscope, and in some configurations can be viewed on a monitor screen. This can advantageously allow the surgeon to maintain a stereoscopic view of the surgical site through the eyepiece of the microscope while simultaneously viewing the superimposed or adjacent image or information, for example, in a stereoscopic or monocular fashion. The OCT scan real-time images, such that the creation of 3D OCT images and / or real-time information based on the OCT can be superimposed onto the real-time view of the one or both eyepieces. In some embodiments, the system and method provide a real-time view that includes real and virtual images from outside and inside the anterior chamber during these procedures.
[0071] Optical microscope 409 can be optically coupled with OCT unit 401. Optical microscope 409 can include a binocular microscope, such as a stereomicroscope, that includes imaging lens elements to image an object onto an ocular or oculars 408 and simultaneously onto camera 405. Camera 405 is configured to capture optical images 505 of the eye. Optical images 505 can be sent to control unit 410 for processing. Camera 405 can include optical elements (e.g., lenses, mirrors, filters, etc.). The camera can capture color images, grayscale images, etc.
[0072] Optical images 505 can be acquired at an appropriate image frame resolution. Image frame resolution can be defined by the number of pixels in a frame. Image resolution can be less than or equal to 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 more, or within a range defined by any two of the foregoing pixel ranges in combination. The imaging device or camera can have a pixel size of less than 1 micron, 2 microns, 3 microns, 5 microns, 10 microns, 20 microns, etc. Camera 405 can be a color camera, such as a 4K or higher resolution color camera.
[0073] Captured optical images 505 can be a sequence of image frames captured at a particular capture rate. In some embodiments, the sequence of images can 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 can be captured at a rate of less than or equal to about one image per 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 can be varied under the direction of control unit 410 according to user input and / or external conditions (e.g., illumination brightness).
[0074] Optical images 505 can be captured in real time, producing images with reduced latency, i.e., with a negligible delay between acquisition of data and rendering of images. Real-time imaging allows the surgeon to feel a smooth flow of motion, which is consistent with the surgeon's tactile motions of surgical instruments (e.g., elongate probes and probe tips) during a surgical procedure. Real-time imaging can include generating images at a rate faster than 30 frames per second (fps) to mimic natural vision with continuous motion, and generating images at twice the rate to avoid flicker (perceived intensity variation). In many embodiments, latency can include the time interval from illumination of the eye by the OCT system until the information is displayed to the user, and can for example not exceed about 100 ms. In many cases, latency includes no more than one or two frames of the image displayed on the display. For embodiments including A-scan imaging beginning from the distal end of a probe inserted into the eye, latency can be less than the image frame rate, e.g., no more than about 10 ms.
[0075] In some embodiments, optical microscope 409 can be coupled to an electronic display device 407. Electronic display 407 can be a heads-up display device (HUD). The HUD can or can not be a component of the microscope system 409. The HUD can be optically coupled into the field of view (FOV) of one or both oculars. The display device can be configured to project the augmented image 507 generated by control unit 410 to the user or surgeon. The display device can be coupled to the microscope via one or more optical elements, such as a beamsplitter or half-mirror 420, such that the physician viewing the oculars 408 can also perceive the augmented image of the real image represented and presented by the display device 407. The display device can be visible through the surgeon's or user's ocular. Alternatively, the HUD can be visible through both oculars 408 and visible to the surgeon as a binocular image in combination with, for example, the optical images formed by components of the microscope.
[0076] The display device or heads-up display 407 is in communication with the control unit 410. The display device can project the augmented image produced by the control unit 410 to the user in real time. As described herein, real-time imaging can include capturing images without substantial latency and allows the surgeon to perceive a smooth flow of motion that is consistent with the surgeon's haptic motion of the surgical instrument during the procedure. In some cases, the display device 407 can receive one or more control signals from the control unit for adjusting one or more parameters of the display, such as brightness, magnification, alignment, etc. The image viewed by the surgeon or user through the ocular or oculars 408 can be a direct optical view of the eye, an image displayed on the display 407, or a combination of both. Thus, adjusting the brightness of the image on the HUD can affect the field of view of the surgeon through the oculars. For example, the processed information and markers displayed on the display 407 can be kept in balance with the microscopic view of the object.
[0077] The heads-up display 407 can 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.
[0078] In some embodiments, the HUD 407 can include an external display. For example, in some embodiments, the HUD can not be perceivable through the oculars. The HUD can be placed in close proximity to the optical microscope. The HUD can include, for example, a display screen. The HUD can include 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 can or can not be a touch screen. The surgeon can simultaneously view real-time optical images of the surgical site and depth information provided by the OCT from the HUD.
[0079] The OCT unit 401 can be coupled to the optical microscope 409. The OCT unit 401 can include a microscope OCT unit 403, a fiber-based OCT unit 402, or a combination of both. The OCT unit 401 can include swept source OCT (SS-OCT), spectral domain OCT (SD-OCT), Fourier domain OCT (FD-OCT), or time domain OCT (TD-OCT), as known in the art with respect to OCT systems. The OCT system can include suitable resolution for viewing tissue structures of the eye, such as Schlemm's canal and / or the collector channel, and can include resolution, for example, in the range of less than 1 to 10 microns, such as in the range of about 3 to 6 microns. The OCT unit 401 can include a low coherence light source suitable for producing OCT image information and interferometric measurement information. The OCT unit 401 can produce an OCT image with depth information and send the OCT image to the control unit 410. The OCT unit can be at least partially controlled by the control unit. The control unit's control of the OCT unit can include, for example, initiation of an OCT scan, parameter setting, or customizable control parameters.
[0080] The OCT unit can include a microscope OCT unit 403. The microscope OCT unit 403 can include components of or share components with the optical microscope 409. In some cases, the microscope OCT unit 403 can include a standalone OCT unit adapted for such use. The microscope OCT unit can be held at a distance from the eye without contacting the eye. The microscope OCT unit can be operably coupled to the optical microscope. The microscope OCT unit can utilize one or more optical elements of the optical microscope, such as an objective lens. The microscope OCT unit 403 can be compatible with the optical microscope system 409. For example, the microscope OCT unit 403 can be configured to allow real-time adjustment of the OCT focal plane to maintain co- focus with the microscope view. In another example, the microscope OCT unit 403 can be able to accommodate changes in the optical power of one or more optical elements of the optical microscope, such as magnification of lenses such as the objective lens or other lenses of the microscope. The microscope OCT unit 403 can be configured to acquire OCT images using an engine (e.g., an SDOCT engine) with a light source (e.g., a NIR light source) and a detector (e.g., a line-scan CCD). Depending on the different types of OCT, different spectrometers can be used, such as a CCD or a photodiode array detector. The microscope OCT unit 403 can be configured to produce OCT images as A-scans, B-scans, or C-scans according to the scanning principle. For example, by performing a fast Fourier transform (FFT), an axial scan (i.e., an A-scan) as a function of depth can be reconstructed. By moving a mirror in the x-direction, a series of A-scan lines can be created that can be stacked together to create a B-scan image or a two-dimensional image. By moving the mirror in both x-y directions, a complete three-dimensional volume image or C-scan image (3D) can be generated. The mirror can be coupled to any suitable actuator known to one of ordinary skill in the art, such as a galvanometer, a translation stage, a MEMs actuator, or a piezoelectric crystal. In some embodiments, the microscope OCT unit 403 can be activated to acquire a B-mode image to provide information about the position of the probe relative to the target position along the anterior-posterior plane of the eye. In some cases, the microscope OCT unit 403 can perform a C-scan to generate a three-dimensional image of the target tissue region.
[0081] The OCT unit can include a fiber-based OCT unit 402. According to some embodiments, the terms "fiber-based OCT unit" and "fiber-based device" can be used interchangeably. The fiber-based OCT unit 402 can include an optical fiber or an array of optical fibers to direct laser pulses inside the eye structure and capture images of the internal eye structure. The fiber-based OCT unit can perform OCT imaging while also delivering laser pulses. The optical fiber can be inserted into the eye and in contact with the tissue inside the eye. In some embodiments, the optical fiber can be the same optical fiber as used in the optical fiber probe 23 for transmitting the laser light. Alternatively, the optical fiber can be a separate optical fiber, such as a standard single-mode or multi-mode optical fiber. The separate optical fiber can be housed in the same optical fiber probe 23. For example, the optical fiber can be encased in an encasing sheath of the probe 23 that is configured to stiffen the single optical fiber. This enables precise identification of the location of the tip of the probe 23 relative to the Schlemm canal, TM, and other target tissues. In some embodiments, a separate optical fiber for returning backscattered signals to a corresponding detector can be employed. A dichroic mirror 32 can be used to deflect the backscattered signals to the detector. In some embodiments, the optical fiber of the OCT unit and the optical fiber probe can be used coaxially as a coaxial endoscope to identify the location of the distal end of the probe relative to the target tissue. Alternatively, the optical fiber can be non-coaxial with the optical fiber probe. In some cases, the probe can include an array of OCT detection fibers located around the treatment fiber.
[0082] The fiber-based OCT unit 402 can be configured to generate axial scan images (A-scan images). It can be beneficial to provide real-time information about the relative position of the distal end of the probe relative to the target site or target location. The A-scan images can be acquired at high frequencies, such as in the range of 10 Hz to 5 kHz. The A-scan images can be processed by the control unit 410 to generate images that include a plurality of position 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 can be averaged to generate an image to improve accuracy. The images from the A-scan can be superimposed onto the optical images to provide position information of the fiber tip relative to the target tissue along the axial direction of the probe.
[0083] The system 400 can further include a user interface 413. The user interface 413 can be configured to receive user input and output information to a user. The user input can relate to control of surgical tools such as the probe 23. The user input can relate to operation of the optical microscope (e.g., microscope settings, camera acquisition, etc.). The user input can relate to various operations or settings with respect to the OCT unit. For example, the user input can include selection of target locations, selection of treatment reference marks, display settings of enhanced images, customizable display preferences, etc. The user interface can include a screen such as a touchscreen and any other user-interactive external devices such as handheld controllers, mice, joysticks, keyboards, trackballs, touchpads, buttons, voice commands, gesture recognition, posture sensors, thermal sensors, touch-capacitive sensors, foot pedals, or any other devices.
[0084] In some embodiments, the microscope-based OCT 403 is used for guidance of the probe 23 and visualization. In some embodiments, the fiber-based OCT 402 is used for guidance of the probe 23 and visualization. In some embodiments, both microscope-based OCT and fiber-based OCT are employed in the system and used for guidance of the probe 23 and visualization. The microscope-based OCT and the fiber-based OCT can perform OCT scans along one or more planes of the eye. In some cases, when both OCTs are employed, the microscope-based OCT can be configured to perform a first OCT scan along an anterior-posterior plane of the eye, while the fiber-based OCT can be configured to perform a second OCT scan along an axis transverse to the anterior-posterior plane. In certain cases, the microscope-based OCT and the fiber-based OCT can be used separately.
[0085] The microscope-based OCT and the fiber-based OCT can or can not include similar scan resolutions. In certain cases, the microscope-based OCT can perform a higher scan resolution than the fiber-based OCT. For example, a B-scan performed by the microscope-based OCT can have a higher resolution than an A-scan performed by the fiber-based OCT. Alternatively, the scan resolution of the fiber-based OCT can be higher than the microscope-based OCT. The axial resolution can be determined based on the bandwidth of the source spectrum. The scan resolution can be determined to provide a fast enough frame rate to ensure real-time feedback. The resolution of each OCT system can be within the ranges described herein.
[0086] Microscope-based OCT and fiber-based OCT can or can not have the same frame / swept rate. In some cases, microscope-based OCT makes B-scans while fiber-based OCT makes A-scans, and volumetric scanning of the surgical site is not required. This can provide higher real-time positional feedback. The frame rate of the cross-sectional view provided by microscope-based OCT and the frame rate of the axial view provided by fiber-based OCT can be influenced by various factors, such as the size of the scan field, the resolution, or the scan rate. In some cases, the two-dimensional OCT images (B-scans) obtained by microscope-based OCT can be used to provide a coarse position of the probe relative to the target tissue or target location, in which case a higher resolution and slower frame rate can be sufficient. In some cases, the axial scan images (A-scans) obtained by fiber-based OCT can provide a fine and precise position of the distal end of the probe relative to small structures (e.g., SCs, CCs, TMs), and thus a higher frame rate can be desired. In some cases, a high frame rate can be desired to minimize motion artifacts and enhance image quality. For example, the axial scans of fiber-based OCT can have a one-dimensional A-scan frame / swept rate of at least 100 fps or higher, with a structural image resolution in a range of, for example, about 1 micron to about 20 microns. In many embodiments, the A-scan frame rate is in a range from about 1 kHz to about 10 kHz. The OCT system can be configured to measure tissue at and up to a distance of at least about 10 mm from the tip of the contact probe, for example, at least about 6 mm from the tip of the probe. These distances can enable the tip of the probe to be aimed at the Schlemm’s canal up to a range of 6 mm from the target site or target location. In some embodiments, the OCT device can include a phase-based OCT configured to detect motion of the distal end of the elongate probe, for example, in a range of about 20 nm to about 1 pm.
[0087] The system can provide enhanced information to the surgeon that is overlaid onto a real-time view of the optical image of the surgical site. This is beneficial to reduce interruptions of the surgical procedure by allowing the surgeon to view supplemental information without having to remove their eyes from the viewing optics of the microscope or heads-up display. The enhanced information can include a magnified view of the various regions of the eye on which they are operating. The enhanced information can include a depth view that includes position information of the probe relative to the target tissue. The enhanced information can include a navigation direction of the elongate probe. The enhanced information can be provided to the surgeon in substantially real-time. The enhanced information can include real-time OCT images. The enhanced information can include a plurality of visual graphical elements generated based on the real-time OCT images and / or static OCT images. In this application, the terms "visual graphical element" and "graphical visual element" can be used interchangeably. The enhanced information can include still images and / or moving images and / or information (e.g., text, graphics, charts, curves, etc.) to overlay in the operating microscope surgical field of view or optical microscope image displayed on the screen.
[0088] In some cases, the enhanced information can be overlaid or superimposed onto the optical image obtained by the optical microscope to form an enhanced image. The enhanced image can be displayed on a screen, such as a heads-up display, a separate viewing monitor, or both. In some cases, the enhanced information can be overlaid on the direct light path image such that the field of view visible to the surgeon through the eyepiece of the microscope includes both the light path image and the overlaid enhanced information. In certain cases, the enhanced information can be superimposed onto the optical image in a picture-in-picture format.
[0089] The control unit 410 can be configured to generate an enhancement layer that includes the enhanced information. The enhancement layer can be a substantially transparent image layer that includes one or more graphical elements. In this application, the terms "graphical element" and "graphical visual element" can be used interchangeably. The enhancement layer can be superimposed on the optical view, optical image, or video stream of the microscope and / or displayed on a display device. The transparency of the enhancement layer allows the user to view the optical image and overlay the graphical elements on top of it. In some embodiments, the enhancement layer can include real-time OCT images or other information obtained by an OCT unit coupled to the optical microscope.
[0090] As described above, the fusion of the optical microscopic image data and the augmented information can include incorporating the augmented information into the optical microscopic image. The augmented image data can include one or more graphical elements associated with the depth information, the target location, and various other supplemental information. The graphical elements can be overlaid on the optical microscopic image, for example, with a beamsplitter. The graphical elements can be directly overlaid on the image of any object visible in the optical microscopic image. The graphical elements can also include any shape, boundary, or outline surrounding the image of any object in the optical microscopic image. The object can be, for example, an instrument (e.g., a probe) inserted into the eye, a portion of the probe, a target tissue (e.g., SC, CC, TM, JCTM, sclera), etc.
[0091] In some embodiments, the graphical elements can be configured to dynamically change as the position or orientation of the probe or instrument changes relative to the target location. For example, the graphical elements can 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, the TM, etc. The graphical elements can be configured to dynamically show the change in spacing between tissue walls or the distance between the probe tip and the target location on the optical image substantially in real-time or near real-time as the relative distance between the probe tip and the target location changes and / or when the probe tip is pressed against a tissue (e.g., the surface of the trabecular meshwork).
[0092] In some embodiments, the augmented information can include the orientation of the probe relative to the target location. The graphical elements can indicate the orientation of the probe relative to the target location. The graphical elements can be configured to dynamically show the orientation of the probe relative to the target location on the optical image substantially in real-time or near real-time as the orientation between the probe and the target location changes. In certain cases, the graphical elements can indicate the direction or axial position of the elongated probe. To indicate the orientation (e.g., direction), the graphical elements can be provided in the form of an arrow. The arrow can be configured to dynamically change based on the movement / advancement of the probe.
[0093] The augmented layer or at least some of the graphical elements can be mapped or matched to the optical image using object recognition techniques or pattern matching techniques (e.g., feature point recognition). A feature point can be a portion of the image (e.g., a scleral landmark, a collector channel pattern, an iris landmark, etc.) that can be uniquely distinguished from the rest of the image and / or other feature points in the image. The feature point can be detected in a portion of the image that is relatively stable under perturbation (e.g., when the illumination and brightness of the image are changed).
[0094] Figure 6An exemplary augmented image or view 600 is shown. As described above, the augmented image 600 can be viewed binocularly by a user or surgeon through the eyepieces of a microscope, and can be displayed on a heads-up display, external display device, or display coupled to a user interface. The augmented image or view can include an optical image 505 or view through the optical path of the eyepieces of the optical microscope. The optical image 505 can include a top view of the eye. The optical image or view can show the anterior portion of the eye. The optical image or view can further show the elongate probe 23. The augmented image or view 600 can include a plurality of graphical visual elements and one or more OCT images adjacent to or overlaid on the optical image, for example by optically coupling the display to the optical path of the microscope using a beamsplitter. The plurality of graphical visual elements can include different shapes and / or colors corresponding to different objects, such that the different objects shown in the optical image can be easily distinguished from one another.
[0095] The plurality of graphical visual elements can include one or more treatment reference markers 601, 602, 603 mapped to one or more target locations. As discussed elsewhere herein, the treatment reference markers 601, 602, 603 can correspond to target locations that are optically invisible to the surgeon in the optical image or light path view 505. According to some embodiments, the target locations can be internal, and treatment of the target locations can involve internal methods. In some cases, the one or more target locations can be determined or identified based on preoperative OCT images. As discussed elsewhere herein, preoperative and / or intraoperative OCT images can be obtained using internal methods and / or external methods. According to some embodiments, the treatment reference markers or target locations can be selected based on locations in a target tissue region that will provide a significant outflow increase after a channel is formed therethrough (e.g., a channel through the trabecular meshwork, the juxtacanalicular meshwork, and the inner wall of the Schlemm canal, thereby providing fluid communication between the anterior chamber and the Schlemm canal). Such selection can be based on identification of certain regions in the collector network or field that are more densely packed, or that contain larger blood vessels or a larger distribution of blood vessels, or that are less obstructed, or that correspond to regions of circumferential flow provided by the Schlemm canal. During real-time optical imaging, the one or more treatment reference markers 601, 602, 603 can be superimposed to the target locations by detecting a pattern of the target locations (e.g., one or more particular collectors) identified from the preoperative OCT images. In some cases, the user or surgeon can be prompted to select the target locations or treatment reference markers through the user interface 413. In some cases, the user or surgeon can be prompted to queue or rank the selected target locations for treatment. Thus, the user or surgeon can specify a desired order in which the target locations are to be treated during the procedure. For example, the user or surgeon can specify that the treatment reference marker 601 corresponds to a target location that is to be treated first, the treatment reference marker 602 corresponds to a target location that is to be treated second, and the treatment reference marker 603 corresponds to a target location that is to be treated third. As discussed elsewhere herein, for example with reference to FIG. 6, the user or surgeon can be prompted to select the target locations or treatment reference markers through the user interface 413. In some cases, the user or surgeon can be prompted to queue or rank the selected target locations for treatment. Thus, the user or surgeon can specify a desired order in which the target locations are to be treated during the procedure. For example, the user or surgeon can specify that the treatment reference marker 601 corresponds to a target location that is to be treated first, the treatment reference marker 602 corresponds to a target location that is to be treated second, and the treatment reference marker 603 corresponds to a target location that is to be treated third. Figure 15 The treatment reference markers can be selected based on locations (e.g., locations in a target tissue region) that have been determined to correspond to larger collectors, a more densely packed collector network or field, and / or a larger outflow. In some cases, the treatment reference markers can be selected in an automated manner. In some cases, the treatment reference markers can be selected manually. The system can be configured to guide the surgeon to sequentially direct a laser fiber to each of the selected treatment reference markers. In some cases, multiple treatment reference markers can be displayed simultaneously, for example at the beginning of the process in which the user selects the target locations. In some cases, the multiple treatment reference markers can be displayed sequentially as the surgical procedure progresses.
[0096] The plurality of graphical visual elements can further include a probe line 604 that is coaxial with the elongated probe 23. The probe line 604 shows the orientation of the probe relative to the one or more target locations. The plurality of graphical visual elements can further include a distal tip marker 605 that overlaps the distal end of the elongated probe. Both the probe line and the distal tip marker can dynamically change position relative to the actual position and orientation of the elongated probe as shown in the optical image or view 505 as the probe is moved within the anterior chamber of the eye. Thus, for example, the surgeon can use a microscope to view the probe 23 as it enters the anterior chamber and can view the probe as it is moved relative to the eye. The OCT detection mechanism can detect the probe 23 and the automated system or processor can generate the probe line 604 in response to the detection. Similarly, the automated system or processor can generate the guide arrows 612.
[0097] The plurality of graphical visual elements can further include one or more guide arrows or markers 612 that extend from the distal tip marker 605 toward the one or more treatment reference markers (e.g., markers 601). The one or more guide arrows 612 can be configured to guide the physician to aim the distal end of the elongated probe to point at the one or more target locations or to advance the elongated probe toward the one or more target locations during the procedure. As discussed elsewhere herein, the one or more target locations can not be optically visible to the surgeon in the optical image or optical view 505. For example, upon selection of a target location, a guide arrow 612 can be generated that points from the distal end of the probe (or the distal tip marker 605) to the selected target location (or the corresponding treatment reference marker) so that the physician can advance the probe parallel to or coaxial with the guide arrow. The one or more guide arrows 612 can radially point in different directions from within the anterior chamber toward target tissue regions including the trabecular meshwork and the Schlemm canal. As discussed elsewhere herein, the height of the Schlemm canal can be about half the height of the trabecular meshwork. In some cases, the one or more guide arrows can automatically appear when the distal end of the probe is located a predetermined distance from the target location, such as when the distal end of the probe is located about 6 mm or less from the target location. Alternatively, the one or more guide arrows can appear in response to user input indicating a selected target location from the plurality of target locations.
[0098] The augmentation layer can further include one or more OCT images overlaid on the optical image. The OCT images or OCT-based images can provide depth information or the position of the probe relative to the target location in a plane that extends perpendicular to the optical image plane (e.g., substantially perpendicular to the optical image plane). In some embodiments, one or more magnified fields of view can be generated based on the OCT images 610, 620. For example, the OCT-based images can be magnified by at least 2 to 5 times compared to the optical image. For example, as shown in FIG. 6B, the OCT-based image 620 can be magnified by a factor of 5 compared to the optical image 610. In some embodiments, the OCT-based images can be magnified by a factor of 2 to 5 times compared to the optical image. Figure 6As shown, a two-dimensional OCT image 610 obtained by microscope OCT is overlaid on the optical image 505. In some cases, the scan used to generate the image 610 is performed intraoperatively. Throughout this application, the terms“microscope OCT” and“microscope-based OCT” can be used interchangeably. Two-dimensional OCT images 610-4, 610-5, 610-6, 610-7, and 610-8 as described elsewhere herein can include embodiments, variations, or examples of the two-dimensional OCT image 610 and can include substantially similar features. For example, one or more of these images can be generated based on intraoperative scans. In some cases, the OCT image 610 can include a B-scan image. Alternatively or in combination, the OCT image 610 can be a three-dimensional image (C-scan). In some cases, a real-time or substantially real-time OCT image can be displayed on the optical image in a picture-in-picture format. Alternatively or in combination, information obtained from the OCT image can be overlaid on the optical image. In some embodiments, the microscope-based OCT scan to produce the two-dimensional OCT image 610 can be performed when the distal end of the probe is within a predetermined distance to a selected target location. As described herein, the microscope-based OCT scan can extend along a plane defined by the current target location (e.g., a target location corresponding to the treatment reference mark 601) and an opening to the eye (e.g., a small incision (puncture) to the cornea).
[0099] The two-dimensional image 610 can include a B-scan OCT image and one or more visual graphical elements. The B-scan OCT image can include, for example, a density plot. The horizontal axis can correspond to the direction of the lateral scan, and the vertical axis can correspond to the scan depth. A grayscale can be plotted at a particular pixel on the OCT image, which corresponds to the size of the depth profile at a particular depth and lateral scan location. The B-scan OCT image can 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 can be generated by averaging multiple B-scan OCT images, such that the two-dimensional image can be updated at a lower rate than the acquisition frame rate of the B-scan OCT images. Alternatively, the two-dimensional image 610 can be updated at the same frame rate as the acquisition frame rate of the B-scan OCT images.
[0100] The B-scan OCT image can be obtained along an OCT image plane along the long axis of the probe 23. The B-scan OCT image plane can be aligned with the probe line 604 along the anteroposterior plane of the eye. For example, the probe axis can be determined by analyzing the optical images acquired with the video, and the microscope-based OCT can be controlled to align the OCT image plane with the long axis of the probe. The microscope OCT plane can be displayed to the user as a line extending along the probe axis, which is displayed on the display and optically coupled to the microscope image.
[0101] In some cases, a two-dimensional OCT scan (B-scan) can be automatically performed in a region where the probe wire intersects with at least one treatment reference marker. The OCT scan region can include an anterior-posterior plane of the eye along the elongated axis of the probe. The OCT scan region can include a portion of the anterior-posterior plane, such as a portion including the distal end of the probe and a region anterior to the probe. The OCT scan region can not include the entire length of the probe. In some cases, a two-dimensional OCT scan can be automatically performed upon detecting that the probe wire is substantially coaxially aligned with one or more guide arrows and is oriented toward one or more treatment reference markers. In certain cases, a two-dimensional OCT scan can be automatically performed upon detecting that the distal end of the elongated probe is a predetermined distance from the target location. The predetermined distance can be in a range of about 1 mm to 6 mm, for example.
[0102] The two-dimensional OCT image 610 can further include a plurality of graphical visual elements overlaid on the OCT image. For example, one or more treatment reference markers 601-1 can be mapped to the target location in the OCT image. As discussed elsewhere herein, the OCT image can or can not be overlaid with the graphical visual elements. In certain cases, the graphical visual elements can be separate from and not overlay the OCT image. According to some embodiments, the OCT image can be overlaid on a microscope image. For example, the OCT image can be overlaid on the microscope image through a microscope, a display, or a microscope in conjunction with a display. The plurality of graphical visual elements can further include a probe marker 611 that indicates at least a position of the probe tip relative to the target location corresponding to the treatment reference marker 601-1 in the depth cross-section. This provides the physician with depth information to guide the physician in adjusting the direction of advancement of the probe in the anterior-posterior plane of the eye (i.e., depth). In some embodiments, a guide arrow 613 can also be overlaid on the OCT image to guide the movement of the probe toward the target location, for example, such that the probe marker 611 advancing along the guide arrow 613 toward the treatment reference marker 601-01 can be visualized by the surgeon. In certain cases, the probe marker 611 can indicate or identify a direction of the long axis of the probe, for example, relative to the target location corresponding to the treatment reference marker 601-1. In certain cases, the probe marker 611 can be coaxial with the long axis of the probe.
[0103] In some cases, the two-dimensional OCT image 610 can provide information regarding another OCT scan. For example, based on the relative position information between the probe tip and the target tissue location, a fiber-based OCT scan can be activated and graphical elements can be overlaid onto the OCT image 610 indicating a scan range of the fiber-based OCT scan (e.g., arrow 614 in FIG. 6B). The scan range can be in a range of, for example, 1 degree to 45 degrees. Alternatively, the fiber-based OCT scan can include an A-scan. Figure 7C
[0104] As described above, a fiber-based OCT scan can be performed by the fiber-based OCT unit 402. The fiber-based OCT scan can be performed along the probe line 605 along the axis of the eye. The fiber-based OCT unit 402 can be configured to automatically perform an OCT scan when the distal end of the elongate probe is detected to be at a second predetermined distance from the target location. The second predetermined distance can be in a range of, for example, about 1 mm to about 6 mm. In some cases, the fiber-based OCT scan can be performed after the microscope-based OCT scan. In some cases, the fiber-based OCT scan can be performed independently of the microscope-based OCT scan. In one example, the fiber-based OCT scan can be activated when the probe line is detected to be aligned with the guide arrow in the optical image identified x-y plane or the microscope OCT image identified cross-section or both in combination. Alternatively, the fiber-based OCT scan can be activated manually.
[0105] In some embodiments, an image 620 or other information based on the fiber-based OCT scan can be generated and overlaid on the optical image in a picture-in-picture like format. In some cases, the scan used to produce the image 620 is performed intraoperatively. In some embodiments, the image 620 can be produced by a microscope OCT. The image 620 can or can not include a fiber-based OCT image. The image 620 can be positioned proximate to the tip of the probe. The image 620 can be positioned in any location within the optical view or on the augmented image. As described elsewhere herein (e.g., in sections Figure 7D The OCT images 620-5, 620-6, 620-7, 620-8, 620-9, 620-90, and 620-91 can include embodiments, variations, or instances of the OCT images 620 and can include substantially similar features. For example, one or more of these images can be generated based on an intraoperative scan.
[0106] The image 620 can include a plurality of graphical visual elements 608, 609-1, 609-2, 609-3, 609-4, 609-5 generated based on a fiber-based OCT scan or a microscope’s OCT scan. In some embodiments, a fiber-based OCT scan is performed between the distal end of the elongated probe and the target location to generate an OCTA scan of the target location including a portion of the trabecular meshwork and Schlemm’s canal. The plurality of graphical visual elements can include one or more A-scan distance markers 608, 609-1, 609-2, 609-3, 609-4, and 609-5. The A-scan distance markers can provide a magnified distance view of the relative position between the probe tip and the tissue structure. The A-scan distance markers enable the physician to view the distal end of the elongated probe when the distal end is no longer visible in the image collected by the optical microscope device, and can also help the physician guide the distal end of the elongated probe towards the target location, and can also instruct the surgeon to consider applying pressure to the trabecular meshwork. In certain cases, the A-scan distance markers can be generated when the distal end of the elongated probe is no longer visible in the microscope image due to the distal end of the elongated probe being obscured by total internal reflection due to the proximity of the corneal-iris angle of the eye.
[0107] The A-scan distance markers can include a plurality of graphical visual elements that show the relative distance between one or more of the distal end of the 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, since the JCTM is a very thin membrane and is positioned adjacent to the inner wall of Schlemm’s canal, the distance markers 609-2 and 609-3 can be so close to each other as to be indistinguishable. In Figure 6 In some embodiments, the graphical elements are displayed as lines and circles, but any other shape or color can be used to mark the relative distance. The plurality of lines can include different colors, patterns, or thicknesses. The plurality of lines can be visually distinguishable from each other. The A-scan distance markers are superimposed on the microscope image of the eye. The microscope image displays a top view of the eye and the A-scan distance markers display a magnified axial view of the target location. In certain cases, the axial view of the target location is magnified by at least 2 to 5 times.
[0108] As Figure 6As shown, for example, the plurality of graphical visual elements can include 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. Any number of lines or markers can be generated depending on the particular tissue structures. One or more of the graphical visual elements can be moved relative to each other to reflect real-time relative positions of the respective objects. For example, as the distal end of the elongated probe advances toward the target location, the first line 608 can appear to move relative to each of the second through sixth lines. The plurality of lines allows the physician to know where the distal end of the elongated probe is positioned relative to 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 advance the distal end of the elongated probe toward the target location in a precise manner that includes the trabecular meshwork and the inner wall of the Schlemm’s canal. In some cases, the plurality of lines allows the physician to advance the distal end of the elongated probe to exert a slight compression on the trabecular meshwork, thereby avoiding over-compressing the trabecular meshwork. In certain cases, the compression of the trabecular meshwork reduces the thickness of the trabecular meshwork, for example, from an original thickness of about 150 microns to about 90 microns. In certain 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 has been penetrated, lines 609-2 and 609-3 can disappear from the augmented image, indicating that the probe tip has passed through the inner wall of the SC (or the inner wall of the SC has otherwise been penetrated), and in certain cases, the physician can retract the elongated probe once the inner wall of the Schlemm’s canal has been penetrated. For example, upon detection of the inner wall of the Schlemm’s canal penetration, the laser emission can automatically stop. In certain cases, when the inner wall of the SC is punctured, a next target location can be displayed in the image to inform the surgeon where to next aim the probe to create another ablation channel in the inner wall of the Schlemm’s canal in the manner described above. The target information can be generated from a fiber A-scan of the new target location. Additionally or alternatively, the target information can be generated from a microscope B-scan of the new target location.
[0109] As discussed above, penetration of the inner wall of the Schlemm's canal can be indicated by the disappearance of line 609-3, which is a graphical visual element (e.g., an A-scan distance marker) corresponding to the inner wall of the Schlemm's canal. In some cases, embodiments of the present application 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 once the trabecular meshwork is compressed and the laser pulse is initiated. In some cases, embodiments of the present application 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 application are configured such that line 609-3 disappears from image 620 when the ablated tissue structure away from the probe tip is converted into gas and enters the Schlemm's canal. According to some embodiments, the laser pulse can penetrate the inner wall of the Schlemm's canal, or the gas ablation product can enter the Schlemm's canal, without the probe tip penetrating the Schlemm's canal. According to some embodiments, an 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 hole. Compression of the trabecular meshwork can be monitored by evaluating the distance between line 609-1, which corresponds to the surface of the trabecular meshwork, and line 609-2, which corresponds to the juxtacanalicular trabecular meshwork. According to some embodiments, 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, local and transient expansion of the Schlemm's canal can occur (e.g., due to the entering gas), and the distance between the inner and outer walls of the Schlemm's canal can increase. At some time after the penetration, as the Schlemm's canal collapses, the distance between the inner and outer walls of the Schlemm's canal can decrease (e.g., from an initial distance of about 200 microns when the canal is expanded to a later distance of about 20 microns when the Schlemm's canal collapses).
[0110] As discussed elsewhere herein, total internal reflection within the eye prevents the surgeon from viewing the outflow structures beyond the "critical angle" of the anterior segment optical viewing path. As discussed elsewhere herein, the Schlemm's canal is a small tube that is located at the junction of the anterior and posterior segments of the eye. The Schlemm's canal is a small tube that is located at the junction of the anterior and posterior segments of the eye. The Schlemm's canal is a small tube that is located at the junction of the anterior and posterior segments of the eye. Figure 6AAs shown, a surgeon can use optical devices 640a, such as an optical microscope, camera, or video camera, to observe structures such as the central iris 619a. This is because 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. Conversely, when using the optical device 640a, due to the dome shape of the cornea, structures within and near the iridocorneal angle 670a, such as the trabecular meshwork 672a, are not visible after total internal reflection. This is because light 660a from the iridocorneal angle 670a undergoes total internal reflection at the interface between the anterior surface structures of the eye (including the cornea and tear film 690a) and air 695a (or other materials with a refractive index different from that of the anterior surface of the eye), and therefore light from structures such as the trabecular meshwork 672a does not pass through the cornea and exit the eye 680a, and cannot be received or detected by the optical device 640a.
[0111] When performing certain minimally invasive glaucoma surgery (MIGS) procedures and other medical treatments, the surgeon will frequently move instruments, such as probes, at various locations within the anterior chamber 607a of the eye 680a. When the instrument, as indicated by the letter V, is located in a central or internal region of the anterior chamber 607a (e.g., near the central iris 619a and pupil 605a), the surgeon can see it directly or optically through a microscope. For example, the instrument can be seen in an optical path view or image provided by optical device 640a. In this sense, region V represents a region or space within the anterior chamber that is optically visible to the surgeon and, for example, can be seen in an image provided by optical device 640a.
[0112] As indicated by the letter N, when the instrument (or a portion thereof, such as the distal end) is positioned toward the periphery or outer region of the anterior chamber (e.g., around line 655a near trabecular mesh 672a), the instrument (or a portion thereof) is optically invisible to the surgeon. For example, the instrument (or a portion thereof) will not be visible in the view or image provided by optical device 640a. In this sense, region N represents a region within the anterior chamber that is invisible to the surgeon and, for example, not visible in the view or image provided by optical device 640a.
[0113] Dashed line 655a provides a representative illustration of the boundary separating space V (visible) from space N (invisible), and corresponds to the “critical angle” discussed elsewhere in this document. Relatedly, dashed line 656a provides a representative illustration of the outer or external boundary of space N.
[0114] Current methods of viewing structures located "outside the critical angle" require the use of a device called a "gonioscope" that changes the optical path by changing the optics of the curved corneal surface. There are primarily two types of contact lenses used for this purpose: those that allow direct access to the iridocorneal angle 670a, and those that use mirrors to access the iridocorneal angle 670a for indirect, e.g., reflected, views. Using such devices enables the technical setup required to operate these contact lenses in real time and to mentally invert the mirror image in the case of indirect gonioscopes.
[0115] Advantageously, embodiments of the present application provide systems and methods that enable a surgeon to effectively and accurately move and position a surgical instrument or probe, such as a Excimer Laser Trabeculotomy (ELT) device, in various desired or target locations in the peripheral anterior chamber (e.g., the entire region N) that would otherwise have their view or image obscured or occluded by total internal reflection. Moreover, embodiments of the present application also enable a surgeon to effectively and accurately move and position a surgical instrument or probe, such as a Excimer Laser Trabeculotomy (ELT) device, in various desired or target locations located peripherally to space N (e.g., through the inner wall 625a of the trabecular meshwork 672a and Schlemm's canal 611a).
[0116] For example, in accordance with embodiments of the present application, systems and methods are described in detail that provide a surgeon with an enhanced view or image of structures that can be optically visualized with a gonioscope, but in the present case, are imaged (e.g., tissues or tissue layers, such as the trabecular meshwork 672a) without a gonioscope, and in addition, can also include images of structures that cannot be visualized by a gonioscope, including OCT images of target locations of target tissue regions (e.g., tissues or tissue layers, such as the juxtacanalicular trabecular meshwork, the inner wall of Schlemm's canal, the outer wall of Schlemm's canal, and the sclera). Such images, if viewable, can be represented by graphical images similar to the structures, and can also be represented by graphical visual elements that identify, for example, target locations and relative locations. Relatedly, in some cases, graphical visual elements that identify target locations can be used to identify specific tissues or tissue layers, such as the trabecular meshwork, the juxtacanalicular trabecular meshwork, the inner wall of Schlemm's canal, the outer wall of Schlemm's canal, or the sclera.
[0117] An enhanced view or image can be generated by superimposing the OCT image and the graphical element, and the graphical element can be aligned with the optical path view or optical path image. The enhanced view or image can also include a graphical element corresponding to the instrument and / or the target location. For example, the enhanced view or image can include a probe marker corresponding to the location of the probe or probe tip. In certain cases, the enhanced view or image can include a graphical element corresponding to a probe line or a guide arrow. The graphical element is particularly useful in providing the surgeon with a visible guide clue for navigating optically invisible spaces N and other areas or structures (e.g., the underlying surface tissue or tissue layers located beneath or around the trabecular meshwork 672a, such as the inner wall 625a of the Schlemm’s canal 611a).
[0118] In this manner, the surgeon is provided with an enhanced view or image in which the target location and / or the instrument (or a portion thereof) is made "visible" to the surgeon by means of one or more graphical visual elements alone or in combination with one or more OCT images, where the target location and / or the instrument (or a portion thereof) is not visible in the optical view or in the optical image without the goniolens. Thus, the systems and methods disclosed herein enable the surgeon to perform glaucoma surgery of outflow structures (e.g., MIGS) without having to use a goniolens.
[0119] Figure 6A Figure (1) of the 'Critical Angle' illustrates other aspects of the critical angle feature described herein. As shown here, light 650a from a location behind the cornea 615a having an angle of incidence "a" relative to the normal 675a of the media boundary 685a (e.g., the interface between the tear film 690a and the air 695a) is partially refracted across the boundary. In contrast, light 660a from a more peripheral location within the anterior chamber 607a having an angle of incidence "b" relative to the normal 675a does not cross the boundary 685a, but is reflected back into the anterior chamber 607a. According to some embodiments, the critical angle "c" can be defined as the threshold angle of incidence above which total internal reflection exists. Thus, as can be seen, below the light 660a, total internal reflection exists, which prevents the surgeon from viewing certain outflow structures located beyond the critical angle "c" of the optical viewing path of the anterior eye. According to some embodiments, the critical angle "c" is about 46 degrees, such that light from tissue structures or devices located within the anterior chamber that exceeds an angle of 46 degrees at the boundary 685a is reflected back into the anterior chamber. In certain cases, the value of the critical angle can be determined based on an average value for a patient population. In certain cases, the value of the critical angle can be determined based on a specific value for a particular patient being treated. In certain cases, the critical angle can correspond to a distance of between about 3 mm to about mm from the trabecular meshwork surface.
[0120] Figure 6BAn exemplary augmented image or augmented view 600b is shown. As described elsewhere herein, a user or surgeon can view the augmented image through the eyepiece of a microscope, for example, in an overlay or heads-up display adjacent to or covering the optically visible structure. Such an augmented image can be displayed on a heads-up display, an external display device, or a display coupled to a user interface. According to some embodiments, the augmented image 600 can be viewed on any of a variety of views of a viewing device such as a display device, a microscope device, a heads-up display, a viewing monitor, a virtual reality viewing device, an augmented reality viewing device, and the like. As shown here, the augmented image or view 600b can include an optical image 505b or a view through the optical path of the eyepiece of an optical microscope, and the optical image 505b includes an anterior or top view of an eye 607b having a sclera 17b. The optical image or view also shows an elongate probe 23b that has been passed through a corneal puncture incision and inserted into the anterior chamber of the eye.
[0121] The augmented image or view 600b also includes an OCT image 610b. As shown here, the OCT image 610b corresponds to a lateral or cross-sectional view of the eye. In addition, the augmented image or augmented view 600b can include another OCT image 620b. As shown here, the image 620b corresponds to an anterior or top view of the eye.
[0122] The dashed line 655b provides a representative illustration of a boundary that separates the optically visible space V within the anterior chamber from the optically non-visible space N within the anterior chamber, and that corresponds to the "critical angle" visibility discussed elsewhere herein. Relatedly, the dashed line 656b provides a representative illustration of a peripheral or outer boundary of the space N within the anterior chamber.
[0123] Embodiments of the present application provide systems and methods that enable a surgeon to effectively and accurately move and position a surgical instrument such as a probe in various desired or target locations in the peripheral anterior chamber (e.g., throughout the space N) that would otherwise be obscured from an optical image or view due to total internal reflection, and also to navigate the surgical instrument to other areas or structures that are optically non-visible (e.g., the underlying surface tissue or tissue layers located beneath or around the trabecular meshwork 672b). For example, as discussed elsewhere herein, the OCT images 610b and 620b can include graphical visual elements that are disposed peripherally of or at least partially disposed peripherally of the dashed line 655b.
[0124] As shown here, OCT image 610b includes a graphic visual element 611b corresponding to the elongated probe 23b, arranged in space V, which is the optically visible space within the anterior chamber to the surgeon. Due to OCT occlusion, a portion of the iris behind the elongated probe may not be visible in image 610b (e.g., below graphic visual element 611b), thus the object causes optical occlusion, obscuring underlying tissue in the OCT image. Correspondingly, OCT image 620b includes a graphic visual element 608b corresponding to the distal end 623b of the elongated probe 23b, similarly arranged in space V. The dashed line 624b indicates the position of the distal end 623b of the probe.
[0125] As discussed elsewhere in this article, for example, see references Figure 6C As the surgeon moves the distal end of the elongated probe from space V to space N, the distal end of probe 23b disappears from the optical image or view 505b, while OCT image 610b allows the surgeon to visualize the probe seamlessly across the transition by observing graphic visual element 611b as they move from space V to space N, and optionally into other areas or structures (e.g., lower surface tissue or tissue layers arranged below or around the trabecular mesh 672b). Similarly, OCT image 620b allows the surgeon to visualize the probe seamlessly across the transition by observing graphic visual element 608b as they move from space V to space N, and optionally into other areas or structures (e.g., lower surface tissue or tissue layers arranged below or around the trabecular mesh). According to some embodiments, the boundary itself (i.e., dashed line 655b) is described herein for illustrative purposes only and is not shown anywhere in the enhanced image or view 600b.
[0126] Figure 6C An exemplary enhanced image or enhanced view 600c is shown. As shown by the dashed line 624c in the optical view or image 505c, the distal end (not shown) of the probe 23c has now emerged from space V ( Figure 6B The enhanced image or view 600c advances to space N (as shown in the diagram). The enhanced image or view 600c also includes an OCT image 610c. As shown here, the OCT image 610c corresponds to a side view or cross-sectional view of the eye. Due to OCT occlusion, a portion of the iris behind the elongated probe may not be visible in image 610c (e.g., below the graphic visual element 611c). Furthermore, the enhanced image or view 600c may include another OCT image 620c. As shown here, image 620c corresponds to a front view or top view of the eye 607c.
[0127] Dashed line 655c provides a representative illustration of a boundary separating optically visible space V within the anterior chamber from optically non-visible space N within the anterior chamber, and corresponding to the "critical angle" visibility discussed elsewhere herein. According to some embodiments, the boundary itself (i.e., dashed line 655c) is described here for illustrative purposes only, and is not displayed anywhere in the augmented image or view 600c. Relatedly, dashed line 656c provides a representative illustration of a peripheral or outer boundary of space N within the anterior chamber.
[0128] OCT image 610c and 620c can include graphical visual elements arranged peripherally to or at least partially within dashed line 655c. As shown here, OCT image 610c includes graphical visual element 611c corresponding to elongated probe 23c arranged in space V (the optically visible to the physician space within the anterior chamber) and extending into space N (the optically non-visible to the physician space within the anterior chamber). Relatedly, OCT image 620c includes graphical visual element 608c corresponding to the distal end of elongated probe 23c arranged in space N.
[0129] Because the surgeon has moved the distal end of elongated probe 23c from space V to space N, the distal end of the probe has disappeared from optical image or view 505c. However, during this movement, OCT image 610c allows the surgeon to visualize the probe seamlessly in transition from space V to space N by observing distal portion 612c of graphical visual element 611c from space V to space N. As discussed elsewhere herein, the surgeon can be guided by other graphical visual elements overlaid with OCT image 610c to move the probe to various locations in space N. During this guided navigation, the surgeon can use OCT image 610c to visualize the position and / or location of probe 23c relative to the anatomical structure of eye 607c by observing the movement of graphical visual element 611c (and optionally, distal portion 612c) relative to other graphical visual elements. For example, the other graphical visual elements can correspond to underlying surface tissue or tissue layers arranged beneath or peripherally to trabecular meshwork 672c.
[0130] Likewise, the OCT image 620c allows the surgeon to visualize the motion of the probe seamlessly during the transition from space V to space N by observing the graphical visual element 608c from space V to space N. As discussed elsewhere herein, the surgeon can be guided by other graphical visual elements overlaid with the OCT image 620c to move the probe to various positions in space N. During this guided navigation, the surgeon can visualize the position and / or location of the probe 23c relative to the anatomical structures of the eye 607c using the OCT image 620c by observing the movement of the graphical visual element 608c relative to the other graphical visual elements. For example, the other graphical visual elements can correspond to the underlying surface tissue or tissue layers disposed beneath or peripheral to the trabecular meshwork. In certain instances, the graphical visual element 608c can be generated as a result of the distal end of the elongated probe no longer being visible in the microscope image due to the distal end of the elongated probe being obscured by total internal reflection as it approaches the corner of the iris-corneal angle of the eye.
[0131] Accordingly, embodiments of the present application are well suited to the observation and navigation of structures in and around the iris-corneal angle of the eye, such as the trabecular meshwork and Schlemm's canal, which would otherwise involve more difficult techniques, such as those requiring the use of a goniolens. Likewise, the systems and methods disclosed herein can allow the surgeon to view the corner structures that are blocked by total internal reflection by providing the surgeon with images or information of those structures that are otherwise less or not visible, such as the collector system. Such images or information can be generated by using OCT optical coherence tomography (OCT) technology.
[0132] FIG Figures 7A-7F Exemplary augmented images 700, 710, 720, 730, 740, 750, 760, 770, 780, and 790 are shown that a physician or user can perceive during a surgical procedure. As discussed above, the augmented images 700, 710, 720, 730, 740, 750, 760, 770, 780, and 790 can be generated by overlaying the images or information generated by the OCT optical coherence tomography (OCT) technology with the images or information generated by the microscope 10. Figure 7AAs shown in Image 700, one or more treatment reference markers 601, 602, 603 corresponding to one or more target locations can be overlaid on an optical image of the eye or a light path view through the eyepiece of an optical microscope for observation and selection by a physician. In the optical image or view shown here, the anterior chamber anatomy of the eye, from the pupil to the trabecular meshwork, is visible. However, as discussed 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. Therefore, according to some embodiments, the optical images or views provided herein are for illustrative purposes only and will not actually include such peripheral structures. One or more target locations can be determined from preoperative OCT images or other images and then mapped onto a real-time optical image, as described elsewhere herein. When selecting a target location, a guide arrow 612 (shown in Image 710) extending from the distal end marker 605 toward the selected treatment reference marker 601 corresponding to the selected target location can be generated to guide the physician in probe orientation to longitudinal alignment with the guide arrow. In some cases, after selecting the first treatment reference marker 601 (or the corresponding target location), treatment reference markers 602 and 603 corresponding to unselected target locations may disappear from the view. Continue Figure 7B (Image 720) The probe can advance toward a selected target location corresponding to a treatment reference mark 601, which is guided by a probe line 604 coaxial with the long axis of the probe and the guide arrow 612. When the probe tip is detected to be within a predetermined distance from the target location, or when the probe line is aligned with the guide arrow, such as... Figure 7C As shown in image 730, an OCT scan can be performed. Relatedly, an OCT scan can be performed if the probe tip is detected to be beyond the "critical angle" of visibility, thus generating images 610-4. As described elsewhere herein, this detection can be based on a real-time optical image. The OCT scan can be a microscopy-based OCT scan, and in some cases, a two-dimensional image can be overlaid on the optical image. In some cases, when a 3D scan (i.e., a C-scan) is desired, arrow 614 indicating the scan range of the microscopy-based OCT can be overlaid on the optical image. The scan range or volume can be defined by two arrows 614 pointing from the fiber tip to the target location. Alternatively, the microscopy-based OCT can be a 2-D scan (i.e., a B-scan). The scan plane can be along the longitudinal axis of the probe and the anterior-posterior plane of the eye. The scan range can be from the fiber tip to the target location, as indicated by arrow 612. In some cases, arrow 614 can indicate the scan range of the fiber-based OCT. Similarly, arrow 614 can define the scan range of a 3D or 2D scan of the fiber-based OCT. The scanning range can be within the range defined by the angle 714, for example from 1 degree to 45 degrees.
[0133] As shown in image 740, microscope-based OCT image 610-4 can include a guide arrow 613 to guide the physician to adjust the direction and advancement of the probe within the anterior-posterior plane of the eye. Alternatively, the guide arrow can indicate the 3D OCT scan range. This OCT image supplements the positional information that can not be perceptible from the optical image. As described elsewhere herein, a probe marker 611 indicating at least the position of the probe tip relative to the target position corresponding to treatment reference marker 601-1 can be overlaid on the microscope-based OCT image. As discussed elsewhere herein, the height of Schlemm’s canal can be about half the height of the trabecular meshwork. According to some embodiments, guide arrow 613 points in the direction toward Schlemm’s canal. The position of treatment reference marker 601-1 can correspond to the position of Schlemm’s canal.
[0134] As Figure 7D As shown in image 750, when distal tip marker 605 corresponding to the distal end of the elongate probe approaches treatment reference marker 601 corresponding to the target position and is detected to be within a predetermined distance from treatment reference marker 601 (or the distal end is detected to be within a predetermined distance from the target position), a second OCT scan can be performed. The second OCT scan can be a fiber-based OCT scan, which can be used to generate image 620-5. In some cases, the second OCT scan can be a B-scan, and an arrow indicating the scan range can be overlaid on the optical image 610-5. Alternatively, the second OCT scan can be an A-scan along the axis of the probe, and the scan range can not be shown on the augmented image. A magnified view of the second OCT scan (A-scan or image 620-5) can be superimposed on the optical image in a picture-in-picture fashion. For clarity, Figure 7D A magnified view of A-scan image 620-5 is shown, which shows a plurality of A-scan distance markers that can be overlaid on the augmented image. A plurality of A-scan distance markers such as lines can be generated based on the A-scan results and overlaid onto the optical image. The distance markers (e.g., fiber tip position marker 608, TM distance marker 609-1) can dynamically change position or spacing to reflect the relative position between the distal end of the probe and the trabecular meshwork surface, JCTM, wall of Schlemm’s canal, outer wall of Schlemm’s canal, or sclera.
[0135] Accurate and precise positioning measurements of the probe tip and associated markers can be used in conjunction with various ophthalmic procedures. In an example, an ELT procedure can be performed under the guidance of the augmented image. As shown in the example, the plurality of A-scan distance markers can include a distance marker 608 corresponding to the distal end of the elongate probe or fiber tip, 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 the Schlemm’s canal, a distance marker 609-4 corresponding to the outer wall of the Schlemm’s canal, or a distance marker 609-5 corresponding to the sclera. With respect to the overall structure of the eye, the outer wall of the Schlemm’s canal can be relatively fixed, while the inner wall of the Schlemm’s canal can move with the trabecular meshwork relative to the overall eye structure. Due to normal physiological processes, the distance between the inner and outer walls of the Schlemm’s canal fluctuates dynamically, for example, between 20 microns (e.g., just filled with aqueous humor) and 200 microns (e.g., filled with aqueous humor and red blood cells). The precision of the ELT laser probe can be approximately 1.7 microns per pulse, and thus can effectively ablate the inner wall of the Schlemm’s canal without ablating the outer wall of the Schlemm’s canal. As discussed elsewhere herein, when the distance marker 609-3 corresponding to the inner wall of the Schlemm’s canal disappears due to penetration of the inner wall, a signal can be transmitted to the laser to stop delivery of the ablation pulses, and a signal can be provided to the surgeon that the penetration has been completed. In this manner, the system can provide an automatic stop signal, an informational stop signal, or both.
[0136] Referring to Figure 7D (FIGURE 760), in the OCT image 610-6, as the microscope image shows the distal tip marker 605 moving toward the treatment reference marker 601, the real-time image can show the probe marker 611 moving toward the trabecular meshwork 9, and thus the surgeon can view the probe movement as the probe tip advances toward the target. As shown in the OCT image 620-6, as the probe tip advances toward the target, the fiber tip distance marker 608 can move closer to a distance marker corresponding to the target tissue region, which can include the trabecular meshwork and the Schlemm’s canal, as delineated 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 the Schlemm’s canal), 609-4 (corresponding to the outer wall of the Schlemm’s canal), and 609-5 (corresponding to the sclera). For clarity, Figure 7D An enlarged view of the A-scan image 620-6 is shown, which illustrates the plurality of A-scan distance markers that can be overlaid on the augmented image.
[0137] As Figure 7EAs shown (zoomed image 770), when the probe tip is in contact with the trabecular meshwork, the probe marker is in contact with the trabecular meshwork, as shown in OCT image 610-7, and the distance marker 609-1 can disappear from the OCT image 620-7. Photocoagulation of the target tissue can be performed when the probe tip is in contact with the trabecular meshwork. The probe coupled to the energy source can be configured to deliver a plurality of pulses to the target location upon detection that the distal end of the elongate 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 and into the Schlemm canal by photocoagulation. For clarity, Figure 7E A zoomed image of the A-scan image 620-7 is shown, which shows a plurality of A-scan distance markers that can be overlaid on the enhanced image.
[0138] As Figure 7E As shown (zoomed image 780), the A-scan distance markers in the OCT image 620-8 can indicate penetration of the inner wall of the Schlemm canal. For example, when the inner wall of the Schlemm canal has been penetrated, as shown in OCT image 610-8, the lines 609-2 and 609-3 can disappear from the enhanced image 780, indicating that the probe tip has passed through the inner wall of the SC of the Schlemm canal (or the inner wall of the Schlemm canal has otherwise been penetrated), and in some cases, the physician can retract the elongate probe. According to some embodiments, fiber-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 canal has been ablated and penetrated. Relatedly, since the ablation process transforms tissue into gas, detection of gas in the Schlemm canal (which was previously only filled with liquid, such as plasma or aqueous humor) can be used as another marker to identify when the inner wall of the Schlemm canal has been penetrated. For example, upon detection of penetration of the inner wall of the Schlemm canal, the laser emission can automatically stop. Alternatively, in another example, the processor can notify the user to manually stop the laser emission. For clarity, Figure 7E A zoomed image of the A-scan image 620-8 is shown, which shows a plurality of A-scan distance markers that can be overlaid on the enhanced image.
[0139] Control unit 410 may include manipulation and control unit 414 configured to automatically control an energy source to deliver multiple pulses upon detection that the distal end of the elongated probe is compressing a portion of the trabecular meshwork. Alternatively, manipulation and control unit 414 may be configured to alert a physician to manually control the energy source to deliver multiple pulses upon detection that the distal end of the elongated probe is compressing a portion of the trabecular meshwork. In some cases, manipulation and control unit 414 may be configured to determine the amount of compression of a portion of the trabecular meshwork by the distal end of the elongated probe based on A-scan distance markers. For example, the amount of compression of the trabecular meshwork may be determined based on the 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 instance, manipulation and control unit 414 is configured to determine whether that portion of the trabecular meshwork has been compressed to a predetermined thickness based on the A-scan distance markers. In some cases, manipulation and control unit 414 may be configured to control the energy source to deliver multiple pulses to induce photoablation of the portion of the trabecular meshwork and the inner wall of the Schlemm tube upon determination that a portion of the trabecular meshwork has been compressed to a predetermined thickness.
[0140] Back Figure 7E The energy source can stop delivering multiple pulses to the target location after detecting that the inner wall of the Schlemm tube has been penetrated by laser pulses. Penetration of the Schlemm tube's inner wall can be indicated by the disappearance of line markers 609-3 corresponding to the inner wall. In some cases, the manipulation and control unit 414 can be configured to detect, in part, whether the photoablation of that portion of the trabecular mesh has penetrated the inner wall of the Schlemm tube based on changes in the relative distance between A-scan distance markers. In some cases, the manipulation and control unit 414 is also configured to alert the physician to retract the elongated probe from the target location upon detection of penetration of the Schlemm tube's inner wall. This alert can be in any form, such as text, a graphic visual element overlaid on an optical image, or an audible alarm.
[0141] like Figure 7F As shown in (Image 790), the manipulation and control unit can be further configured to alert the physician upon successful completion of the current operation to locate another treatment reference marker corresponding to a mapped position of another target location of the eye. For example, when penetration of the inner wall of the Schlemm tube is detected and the laser pulse is stopped, a subsequent treatment reference marker 602 corresponding to the next target location can appear and guide the surgeon to move to the next treatment location, as described elsewhere herein. For subsequent target locations, some or all of the above steps can be repeated. For clarity, Figure 7F An enlarged view of A-scan image 620-9 is shown, which illustrates multiple A-scan distance markers that can be overlaid on the enhanced image.
[0142] Figure 8 Another example of a system 800 according to an embodiment is shown. The system 800 can be substantially similar to the system 400 described in Figure 4 and can include one or more components of the system 400. The system 800 can utilize OCT measurements of the eye E with only the fiber-based OCT 402. The microscope 409 can include the same optical microscope as described in Figure 4 In this case, the OCT unit 401 can include only the fiber-based OCT 402, and the OCT unit can not share optical components of the microscope 409. The A-scan information provided by the probe can be used to determine the distance from the trabecular meshwork. The surgeon can use the A-scan information provided on the display to align the probe with the Schlemm’s canal. For example, the A-scan information can show the surgeon an indication of the distance to the Schlemm’s canal and an indication as to whether the distal end of the fiber probe is aligned with the Schlemm’s canal.
[0143] Figure 9 Exemplary magnified images or optical views 900 and 910 shown to a user during a procedure using the system 800 are shown. The steps of superimposing guide arrows, probe markers, probe tip marker 605, treatment reference markers onto the optical images or views can be similar to those described in images 700, 710, and 720 in Figure 7A and 7B The direction and travel direction of the probe can be adjusted so that the probe axial marker is aligned with the guide arrow. The alignment of the probe in the x-y plane can be achieved by using a top view of the optical image of the eye. The position of the probe relative to the target position in the anterior-posterior plane can be estimated or calculated from preoperative OCT images. When the probe tip (corresponding to the distal end marker 605) is detected to be within a predetermined distance from the target position (corresponding to the treatment reference marker 601), a fiber-based OCT scan can be performed. As described above, the fiber-based OCT scan can be an axial scan (i.e., an A-scan) or a B-scan. The fiber-based OCT scan can be the same as described elsewhere herein. A magnified view 620-90 of the OCT results can be overlaid on the optical image. As previously described, the OCT image 620 can include a plurality of A-scan distance reference markers, such as 608, 609-1. Alternatively, when a B-scan is performed, the OCT image can include a two-dimensional OCT real-time image. The OCT images 620-90 and 620-91 can be used to guide the physician to advance the tip axially and provide information about the relative position of the probe tip relative to one or more tissue structures (e.g., the trabecular meshwork 609-1). For example, as shown in image 910, as the tip is advanced, the distance marker 608 in the OCT image 620-91 can move towards other distance markers. For clarity, Figure 9Enlarged views of A-scan images 620-90 and 620-91 are shown, which show a plurality of A-scan distance markers that can be overlaid on the enhanced image.
[0144] Figure 10 Another example of a system 1000 according to embodiments of the application is shown. The system 1000 can utilize only a microscope-based OCT unit 403. The OCT unit in the system 1000 can include microscope-based OCT. In this case, OCT-based enhancement information overlaid on the optical image can be provided by an OCT scan performed by the microscope-based OCT unit 403. For example, a microscope-based OCT scan can be performed when the probe tip is detected to be within a predetermined distance from a target location. The scan plane can be along the anterior-posterior plane of the eye E and along the probe elongation axis, as described elsewhere herein. The OCT scan can be a high resolution scan. For example, the structural scan resolution can be in the range of about 1 pm to about 5 pm. The scan can provide position information of the probe tip relative to the target location or tissue structure (e.g., the trabecular meshwork, the juxtacanalicular trabecular meshwork (JCTM), the inner wall of Schlemm’s canal, the outer wall of Schlemm’s canal, or the sclera). In some cases, a real-time OCT image with markers such as image 610 can be generated and overlaid 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 can be generated from the microscope-based OCT, such as image 620, and overlaid on the optical image.
[0145] Figure 11 An example of an OCT guidance system 1100 according to embodiments of the application is shown schematically. The system 1100 can include the same components as the system 400 described in Figure 4 “OCT Guidance System for Glaucoma Surgery” section. Except that the system 1100 can not include a separate laser unit for the fiber optic probe. As described elsewhere herein, the system 1100 can be used to guide any surgical tool inserted inside the eye E. For example, the system 1100 can provide guidance to position a stent location for an implant. Examples of implant devices include a microstent and a shunt that aligns with the suprachoroidal space and Schlemm’s canal, respectively. In this case, the fiber for the OCT scan can be coaxial with the surgical tool 1101, which can not include a fiber for the ELT procedure.
[0146] Figure 12A -D shows an example of an instrument that can be used in conjunction with the provided systems; various instruments can not be coupled to a laser source. The device can include a substantially elongated shape. As Figure 12AAs shown in the anterior view of the eye shown, the augmented information can be overlaid on the optical view or image 505 of the eye and instrument in a similar manner as described elsewhere herein. For example, one or more treatment reference markers 601 and an arrow or probe line 604 coaxial with the instrument 24 can be superimposed onto the optical image. As shown here, the eye includes the iris 19, the trabecular meshwork 9, and the cornea 15. It can be appreciated that instead of depicting the cornea 15, the image can also depict the sclera in place of the cornea. In the optical image or view 505 shown here, the anatomical structures of the eye within the anterior chamber from the pupil to the iridocorneal angle can be seen. However, as discussed elsewhere herein, peripheral structures at or near the iridocorneal angle, such as the trabecular meshwork 9, can not be visible in the optical image or view. Thus, the optical image or view provided here is for illustrative purposes only and would not, in practice, include such peripheral structures, according to some embodiments.
[0147] A guide arrow 612 can be displayed to guide the direction and orientation of advancement of the instrument 24. In some cases, the optical fiber used for OCT scanning can be coaxial or enclosed in the housing of the instrument 24 to provide a relative position of the distal end of the instrument with respect to the treatment site. In some cases, the elongated probe 24 can include one or more stents 1220a loaded thereon, and the stents 1220a can be implanted in the trabecular meshwork 9 and configured to connect the anterior chamber to the Schlemm canal and form a permanent opening in the Schlemm canal. Embodiments of the system described herein can be configured to assist the physician in advancing and implanting the one or more stents 1220a at the target site with the aid of graphical visual elements (e.g., treatment reference markers and arrows) aligned with the real microscope image of the eye. For example, the disclosed system can be configured to assist the physician in advancing and sliding the stents 1220a into the Schlemm canal and permanently positioning the stents in the Schlemm canal with the aid of graphical visual elements (e.g., treatment reference markers 601, probe line 604, and / or guide arrow 612) aligned with the microscope image.
[0148] In some cases, the system can be configured to assist the physician in advancing a plurality of stents along the elongated axis of the elongated probe, injecting the plurality of stents into the Schlemm canal, and permanently placing the plurality of stents in the Schlemm canal with the aid of graphical visual elements aligned with the microscope image. For example, as shown in FIG. 1, the elongated probe 1210b includes a housing 1212b and an insertion mechanism 1214b. As shown in FIG. 2, the insertion mechanism 1214b can be loaded with a stent 1220b, and the stent 1220b can include a head 1222b, a thorax 1224b, a flange 1226b, and an outflow hole 1228b. Figure 12B Figure 12B Diagram (3) depicts two stents 1220b implanted in the trabecular meshwork 9 as viewed from the anterior chamber. As shown here, the flange 1226b of each stent 1220b includes an inlet hole 1227b that is in fluid communication with one or more outflow holes (not shown). Because the stents 1220b do not extend significantly from the trabecular meshwork 9 toward the central portion of the anterior chamber, the stents are not visible in a microscope image or view due to total internal reflection at the corners near the corneal limbus of the eye. OCT guidance embodiments as disclosed elsewhere herein are well suited to assist the surgeon in delivering the stents (when loaded on an elongated probe) to the trabecular meshwork 9. For example, with reference to Figure 6 The OCT guidance embodiments discussed can be used to help guide the surgeon in implanting the stents in a target location in the trabecular meshwork. In some cases, the target location can correspond to the location of the collector canaliculi, or based on the distribution or density of the collector canaliculi. With reference back to Figure 12B As shown in diagram (4), when the stents 1220b are implanted in the eye, the flanges 1226b are in the anterior chamber 7, the thorax (not visible) is in the trabecular meshwork 9, and the head 1222b is in the Schlemm canal 11. Because the inlet hole is in fluid communication with the outflow hole, aqueous humor can flow from the anterior chamber into the Schlemm canal.
[0149] As Figure 12C As shown in diagrams (1)-(7), in some cases, the elongated probe 1210c can include a microstent 1220c loaded thereon, and the microstent 1220c can be configured to form a permanent conduit between the anterior chamber 7 and the supraciliary space 27. In some cases, the stent 1220c can include a sleeve 1221c (e.g., a titanium sleeve), an inlet 1222c, a retention feature 1223c, and an outlet 1224c. The systems disclosed herein can be configured to help the physician advance the microstent 1220c to the supraciliary space 27 with the aid of graphical visual elements aligned with a microscope image. For example, the system can be configured to help the physician advance the microstent 1220c to the supraciliary space 27 using real-time OCT images of the supraciliary space 27 produced by any of the OCT devices described elsewhere herein. The system can also be configured to help the physician position the proximal collar portion or sleeve 1221c of the microstent 1220c in the anterior chamber angle 28 with the aid of graphical visual elements aligned with a microscope image. OCT guidance embodiments as disclosed elsewhere herein are well suited to assist the surgeon in delivering the stents (when loaded on an elongated probe) to the anterior chamber angle. For example, with reference to Figure 6 The OCT guidance embodiments discussed can be used to help guide the surgeon in implanting the stents in a target location in the anterior chamber angle.
[0150] In some cases, as Figure 12DSubconjunctival filtration. As shown in inset (1), a syringe or elongated probe 2120d can be inserted through an incision in the cornea 15 and passed through the anterior chamber 7. As shown in inset (2), the elongated probe can be further advanced into the subconjunctival space 27. Inset (3) shows a distal portion of the gel scaffold 1220d deployed into the subconjunctival space. Inset (4) depicts the gel scaffold 1220d in an implanted position, functioning to drain aqueous humor from the anterior chamber 7 into the subconjunctival space 27. The gel scaffold 1220d can be configured to create a channel through the sclera to allow aqueous humor to flow from the anterior chamber into the subconjunctival space. The systems disclosed herein can be configured to assist the physician in positioning and implanting the gel scaffold 1220d with the aid of graphical visual elements aligned with the microscope image. For example, the OCT-guided embodiments disclosed elsewhere herein are well suited to assist the surgeon in delivering the scaffold (when loaded on an elongated probe) to the subconjunctival space. Relatedly, reference is made to Figure 6 The OCT-guided embodiments discussed can be used to assist in guiding the surgeon in implanting the scaffold into a target location in the subconjunctival space.
[0151] Figure 13 A flowchart of a method 1300 for determining target treatment locations and probe locations according to embodiments is shown. The method can use one or more of the systems described herein. In a first step 1301, an anterior image of an eye can be obtained by a camera or video camera of an optical microscope. In a second step 1303, one or more target locations (or treatment reference markers corresponding to the target locations) are overlaid or mapped onto the optical image or optical view of the user. The one or more target locations can be determined based on reference image data including an OCT image of the eye. The OCT image of the eye can be obtained using an OCT device prior to a surgical procedure. In some cases, the OCT image of the eye can include an image of an anterior segment of the eye including a network of collector channels, and can identify one or more individual collector channels in at least two quadrants from the OCT image. The preoperative OCT image can have high resolution.
[0152] Figure 15An example of a pre-operative OCT image 1500 is shown, as well as enhanced pre-operative OCT images 1510 and 1520 showing the collection channels and target locations. As shown in the example, the pre-operative OCT image can be a 3D image. One or more collection channels and / or target locations can be identified from the high resolution pre-operative image. As discussed elsewhere herein, the trabecular meshwork 9 is in fluid communication (through the Schlemm canal) with a series or network of collection channels 12. The OCT image 1500 depicts a location 9a of the trabecular meshwork 9 in relation to subsurface tissue where the number or density of collection channels 12 is relatively high. Conversely, a location 9b of the trabecular meshwork 9 is in relation to subsurface tissue where the number or density of collection channels 12 is relatively low.
[0153] In some cases, the enhanced information, such as the guide arrow 613, can be overlaid on the pre-operative image. For example, the pre-operative OCT image 1510 is overlaid with a guide arrow 613 that can be used to guide the elongated probe toward the target location. As shown, the pre-operative OCT image 1510 can also be combined with a microscope view or image 1505 in which the iris 19 and the elongated probe 23 can be seen. Figure 15
[0154] As discussed elsewhere herein, the treatment reference marks can correspond to or can be mapped to target locations in the OCT image. In some cases, one or more target locations can be identified or designated in the OCT image. In some cases, the one or more target locations (e.g., 621, 622) are at locations corresponding to one or more individual collection channels (or alternatively, to one or more regions of dense network or field containing collection channels) that are in close proximity to the inner wall of the trabecular meshwork and Schlemm canal. As shown here, a treatment reference mark 601 can be overlaid on the OCT image and / or microscope view or image at the target location 621, and a treatment reference mark 602 can be overlaid on the OCT image and / or microscope view or image at the target location 622. In some cases, the location of the one or more individual collection channels (or network regions) can be aligned relative to at least one distinguishable anatomical structure in the eye, such as the iris. Multiple target locations can be estimated manually by the user or automatically by the processor. As described elsewhere herein, the user or physician can be allowed to select the target locations through a user interface. According to some embodiments, Figure 15 The techniques for identifying target locations and / or treatment reference marks depicted in FIGS. 15-16 can be used in conjunction with subsequent gonioscopy facilitated treatments. According to some embodiments, Figure 15 The techniques for identifying target locations and / or treatment reference marks depicted in FIGS. 15-16 can be used in conjunction with other OCT guidance techniques discussed herein with reference to, for example, Figure 6 As discussed elsewhere herein, the OCT guidance techniques can be used in conjunction with other techniques for identifying target locations and / or treatment reference marks. For example, the OCT guidance techniques can be used in conjunction with the techniques discussed with reference to FIGS. 17-18. Figure 15 As shown, the OCT image can be used to identify and / or target the collector or network of collectors. The target location can be selected according to where the collector is larger and / or the network or field of collectors is more dense (e.g., the 4 o'clock position), as opposed to where the collector is smaller and / or the network of collectors is less dense (e.g., the 2 o'clock position). In some cases, the target location can be designated as where in the Schlemm canal the collector is larger, the network or field of collectors is more dense, and / or the collector, network, or field is least obstructed (e.g., the outflow is greatest). In some cases, the target location can be ranked or ordered according to these size, density, and / or obstruction or flow parameters. In some cases, the OCT image can be used to determine where in the Schlemm canal the flow is circumferential and / or where the flow is partitioned, and the target location can be selected to correspond to where the flow is circumferential. In some cases, the surgeon can use the OCT image, such as the image shown, to make decisions about where to place or move the treatment probe or device without regard to target location assignments or graphical visual element overlays. For example, the OCT image can show the collector, network, and / or field of collectors, and the surgeon can make probe positioning or movement decisions based on such anatomical features. The OCT image can enable the surgeon to identify the target location or desired treatment location positioned in the tissue without the need to mark or label that target location or treatment location, for example, with a graphical visual element or treatment reference marker. Figure 15
[0155] Referring back to Figure 13 In a third step 1305, one or more guidance graphical elements can be overlaid onto the optical image so that the physician can adjust the direction of advancement and / or orientation of the probe to move toward the selected target location at least in the plane of the optical image. In a fourth step 1307, a microscope-based OCT image can be obtained along the longitudinal axis of the probe and the anterior-posterior plane of the eye when the probe tip is detected to be within a predetermined distance from the target location. Next 1309, the microscope-based OCT image and associated markers can be overlaid on the optical image to guide the physician to adjust the direction of the probe and the direction of advancement in the plane of the OCT image. In a sixth step 1311, a fiber-based OCT scan can be performed along the axis of the probe. The fiber-based OCT scan can be an A-scan or a B-scan to provide relative position between the probe tip and the tissue when the probe tip is within a predetermined distance from the target location. The fiber-based OCT image and / or distance markers generated based on the OCT image can be overlaid onto the optical image 1313. In an eighth step 1315, the treatment can be displayed or viewed in real-time at the treatment location so that the motion of the probe can be adjusted based at least in part on the augmented information.
[0156] While Figure 13 A method according to some embodiments is shown, but one of ordinary skill in the art will recognize that many variations can be taken. For example, steps can be performed in any order. Certain steps can be deleted, certain steps can be repeated, and certain steps can include sub-steps of other steps. The method can also be modified according to other aspects of the disclosure provided herein.
[0157] As Figure 13A shown, embodiments of the present application include methods for performing a surgical procedure at a target location of a patient's eye. An exemplary treatment method 1300a includes viewing a real-time view on a viewing device as shown in step 1310a, advancing a distal end of an elongated probe within an anterior chamber of the eye toward a target tissue region while viewing the viewing device as shown in step 1320a, and performing a surgical procedure using the elongated probe when the distal end of the elongated probe is not visible in a microscope view or microscope image provided by the viewing device and information about a relative position of the distal end of the elongated probe with respect to the target location is perceived from the microscope view or microscope image as shown in step 1310c. According to some embodiments, the target location is in a target tissue region of the patient's eye. In some cases, the real-time view includes a microscope view or an augmented image of the eye. The augmented image can include a microscope view of the eye or a microscope image of the eye. The augmented image can further include an optical coherence tomography (OCT) image of the target tissue region. The OCT image can be aligned with the microscope view or microscope image. A graphical visual element corresponding to the target location can be overlaid on the microscope view or microscope image. The target location can not be visible in the microscope view or microscope image. According to some embodiments, the method includes advancing the distal end of the elongated probe within the anterior chamber of the eye toward the target tissue region while viewing the microscope view or augmented image on the viewing device. In some cases, the distal end of the elongated probe is initially visible in the microscope view or microscope image, and thereafter becomes invisible in the microscope view or microscope image due to total internal reflection in a region of the eye. In some cases, the region of the eye includes the target tissue region. In some cases, the region is beyond "critical angle" visibility as discussed elsewhere herein.
[0158] As Figure 13BAs shown, embodiments of the present application include methods of assisting a surgeon in performing a surgical procedure on a patient's eye. As shown here, the method 1300b includes providing a real-time view to the surgeon, as shown in step 1310b. In some cases, the real-time view includes a microscope view of the eye 1320b. In some cases, the real-time view includes an augmented image, such as augmented image 1330b or augmented image 1340b. In some cases, the augmented image 1330b (form (A)) can include a microscope view of the eye 1320b. In some cases, the augmented image 1340b (form (B)) can include a microscope image of the eye 1350b. Either form of augmented image (i.e., augmented image 1330b or augmented image 1340b) can include an OCT image of a target tissue region of the eye 1360b. The OCT image 1360b can enable identification of a target location. In some embodiments, the surgeon 1390 can view the microscope view 1320b and then view the augmented view 1330b or the augmented view 1340b. Thus, the surgeon 1390 can be provided with two different forms of real-time view, either the microscope view 1320b and the augmented image 1330b, or the microscope view 1320b and the augmented image 1340b. According to some embodiments, the OCT image 1360b can be aligned with the microscope view 1320b or the microscope image 1350b. According to some embodiments, the actual target location is not visible in the microscope view 1320b or the microscope image 1350b. According to some embodiments, the augmented image (1330b or 1340b) enables the surgeon 1390b to perceive information about the relative position of the distal end of the elongated probe relative to the target location when the distal end of the elongated probe is not visible in the microscope view 1320b or the microscope image 1350b.
[0159] In some embodiments, when the treatment probe is initially inserted into the anterior chamber of the patient's eye, the surgeon 1390b views a microscope image 1320b. Subsequently, an OCT image 1360b (e.g., showing collecting tubes or networks) may be overlaid on the microscope image 1320b, for example using alignment techniques discussed elsewhere herein. The surgeon can then decide where to deliver treatment (e.g., applying laser ablation energy to the inner walls of the trabecular meshwork, peritrabecular meshwork, and Schlemm's tube). In some cases, this may involve the surgeon using graphic visual elements or treatment reference markers to mark or label the treatment location. In some cases, a computer system may determine where to place the graphic visual elements or treatment reference markers. Following the steps described above, the surgeon can move or position the treatment probe within the anterior chamber of the eye, and subsequent OCT imaging protocols can be used (e.g., through the overlay of graphic visual elements) to facilitate the guidance or navigation of the probe to the target or desired treatment location. In some cases, graphic visual elements may be overlaid on the microscope view or image before the probe is placed into the anterior chamber. In some cases, graphic visual elements may be overlaid on the microscope view or image after the probe has been placed into the anterior chamber. In some cases, graphic visual elements can be overlaid on the OCT image before the probe is placed in the anterior chamber. In other cases, graphic visual elements can be overlaid on the OCT image after the probe is placed in the anterior chamber.
[0160] Control unit 410 (e.g.) Figure 4 , 5 (As shown in 8, 10, or 11) may include one or more processors (e.g., Figure 14 The processor 1405 depicted in the image is configured to execute... Figure 13 , 13 Instructions for one or more steps shown in A and 13B, and operations as described elsewhere herein. Similarly, control unit 410 may include a computer system (e.g., Figure 14 Any other component of or connected to the computer system 1401 depicted in the figure.
[0161] Although some of the methods and apparatus disclosed herein are described in the context of ablation, the user interface and display can be configured to guide the surgical placement of implants, as described herein. For example, a target location can be indicated with reference to a collecting tube, and the surgical placement of the implant can be directed, for example, to a target location near the Schlemm tube. Arrows and other features displayed on a heads-up display can be used to indicate multiple locations of multiple surgical implants to be placed in the eye, such as implants used to form an opening leading to the Schlemm tube. The implant can be placed by, for example, mechanically (e.g., with a sharp instrument) forming an opening in the Schlemm tube, and then placing the implant at the target location.
[0162] Each of the computations or operations described herein can be performed using a computer or other processor with hardware, software, and / or firmware. Various method steps can be performed by a module, and a module can comprise any of a variety of digital and / or analog data processing hardware and / or software arranged to perform the method steps described herein. Modules can optionally comprise data processing hardware adapted to perform one or more of these steps by having appropriate machine programming code associated therewith, with modules for two or more steps (or portions of two or more steps) integrated into a single processor board or separated into different processor boards in any of a variety of integrated and / or distributed processing architectures. These methods and systems will often employ a tangible medium embodying machine-readable code having instructions for performing the method steps as described elsewhere herein. All features of the described systems can be adapted to the described methods, and vice versa.
[0163] The processor can 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 microprocessor, logic device, etc. Although the present disclosure is described with reference to a processor, other types of integrated circuits and logic devices can also apply. The processor or machine can not be limited by data operation capability. The processor or machine can perform 512-bit, 256-bit, 128-bit, 64-bit, 32-bit, or 16-bit data operations.
[0164] In some embodiments, the processor can be a processing unit of a computer system. Figure 14 A computer system 1401 that can be configured to implement any of the computing systems or methods disclosed in this application is shown. The computer system 1401 can include a mobile phone, a tablet, a wearable device, a laptop computer, a desktop computer, a central server, etc.
[0165] The computer system 1401 includes a central processing unit (CPU, also "processor" and "computer processor") 1405, which can be a single core or multi core processor, or a plurality of processors for parallel processing. CPU can be a processor as described above. The computer system 1401 also includes memory or memory location 1410 (e.g., random access memory, read only memory, flash memory), electronic storage unit 1415 (e.g., hard disk), communication interface 1420 (e.g., network adapter) for communicating with one or more other systems, and peripheral devices 1425, such as cache, other memory, data storage, and / or electronic display adapters. In some cases, communication interface can enable the computer to communicate with another device from which the input data is received for analysis. The computer can be capable of receiving 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), which can be a motherboard. The storage unit 1415 can be a data storage unit (or data repository) for storing data. The computer system 1401 can be operatively coupled to a computer network ("network") 1430 by means of the communication interface 1420. The network 1430 can be a wide area network, such as the Internet, and / or an intranet and / or extranet, which are communicatively coupled together by a wide area network, such as the Internet. In some cases, the network 1430 is a telecommunications and / or data network, and / or the Internet. The network 1430 can include one or more computer servers, which can enable distributed computing, such as cloud computing. In some cases, the network 1430 can implement a peer-to-peer network, which can enable devices coupled to the computer system 1401 to behave as a client or a server.
[0166] The CPU 1405 can execute a sequence of machine-readable instructions, which can be embodied in a program or software. The instructions can be stored in a memory location, such as the memory 1410. The instructions can direct the CPU 1405 to perform various actions, including the methods of the present disclosure. Examples of actions performed by the CPU 1405 include fetch, decode, execute, and writeback.
[0167] The CPU 1405 can be part of a circuit, such as an integrated circuit. One or more other components of the system 1401 can be included in the circuit. In some cases, the circuit is an application specific integrated circuit (ASIC).
[0168] The storage unit 1415 can store files, such as drivers, libraries and saved programs. The storage unit 1415 can store user
[0169] The computer system 1401 can communicate over the network 1430 with one or more remote computer systems. For instance, the computer system 1401 can communicate with a remote computer system of a user. Examples of remote computer systems include personal computers, tablet or slate computers, smart phones, personal digital assistants and the like. A user can access the computer system 1401 via the network 1430.
[0170] The methods described herein can be implemented by way of machine (e.g., computer processor) executable code stored on an electronic storage location of the computer system 1401, such as, for example, on the memory 1410 or electronic storage unit 1415. The machine executable or machine readable code can be provided in the form of software. During use, the code can 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 ready execution by the processor 1405. In some cases, the electronic storage unit 1415 can be precluded, and machine executable instructions are stored in the memory 1410.
[0171] The code can be pre-compiled and configured for a machine with a processor suitable for executing the code, or can be compiled at runtime. The code can be provided in a programming language that can be selected to enable the code to be executed in the pre-compiled or as-compiled manner.
[0172] Various aspects of the systems and methods (e.g., computer system 1401) provided herein can be embodied in programming. Various aspects of the technology can be thought of as "products" or "articles of manufacture" typically in the form of machine (or processor) executable code and / or associated data that is carried on or embodied in a type of machine readable medium. Machine-executable code can be stored on an electronic storage unit, such as a memory (e.g., read-only memory, random-access memory, flash memory) or a hard disk. "Storage" types media can include any or all of volatile memory, non-volatile memory, removable storage media, and / or non-removable storage media. Tangible storage media include computer-readable storage media, which can include any or all of volatile memory, non-volatile memory, removable storage media, and / or non-removable storage media. Tangible storage media exclude signals per se. Non-volatile memory includes, for example, optical and / or semiconductor memories. Removable storage media includes, for example, floppy disks, flash memories, "ZIP" disks, "Iomega" removable disks, etc. Non-removable storage media includes, for example, optical and / or semiconductor memories, including, but not limited to, disks embedded in a computer or other data processing system, etc. Such computer- readable storage media and / or storage device(s) as here embodied no longer carry software, but carry a persistent, explicit software command to retrieve the software from another computer-readable medium or communication interface. As used herein, unless restricted to non-transitory, tangible "storage" media, terms such as computer or machine "readable medium" refer to any medium that participates in providing instructions to a processor for execution.
[0173] Hence, a machine readable medium, such as computer-executable code, can take many forms, including but not limited to, a tangible storage medium, a carrier wave medium or physical transmission medium. Non-volatile storage media include, for example, optical or magnetic disks, such as any of the storage devices in any computer(s) or the like, such as can be used to implement the databases, etc. shown in the drawings. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include, for example, coaxial cables, copper wire and fiber optics, including the wires that comprise a bus within a computer system. Carrier wave transmission media can take the form of electric or electromagnetic signals, or acoustic or light waves such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media therefore include for example: a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, CDTV, DVDs, any other optical medium, punch cards, paper tape, any other physical storage medium, RAM, ROM, PROM, and EPROM, FLASH-EPROM, any other memory chip or cartridge, a carrier wave transported over an Internet or other packet-switched network or telephone or other communications line or link, or any other medium from which a computer can read programming code and / or data. Many of these forms of computer readable media, mentioned above and others, can be beneficial for the additional efficiency greater than the RAM, because they allow the programs to be off-loaded, that is, to be saved in the non-volatile memory or storage medium as "offline" code. Other forms can be loaded, in whole or in part, into the RAM of the computer, such as the operating system, programs, and / or data for the efficient execution of the programs by the processor(s) of the computer as needed.
[0174] The computer system 1401 can include or be in communication with an electronic display 1435, which can represent a user interface for providing, for example, a management interface. Examples of UIs include, without limitation, a graphical user interface (GUI) and a web-based user interface. The user interface 1440 can be the same as the user interface 413 as described in the Figure 4 Alternatively, the user interface can be a separate user interface.
[0175] The computer system 1401 can include various other computer components to facilitate communication with external devices such as a microscope system, camera, OCT unit, laser unit, external processor or memory. The communication module can include appropriate means for instruction and data transfer, for example, double data rate. Communication can be carried out in various ways, for example, peripheral component interconnect card, computer bus, including but not limited to PCI express, PCI-X, HyperTransport, etc. The appropriate communication means can be selected according to the bandwidth and compatibility requirements of the external device with the central processing unit 1405. For example, one data bus can be used for command transfer to the laser unit 31 (e.g., AXI4lite bus), and a different data bus (e.g., AXI4 bus) can be used for image data transfer. Alternatively or additionally, wireless communication can be employed.
[0176] 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.
[0177] As used herein, the terms “overlay,” “overlaid,” “superimposed,” “superimposed on,” and the like can also include, in some embodiments, other image or information combination techniques, including “underlay,” “underlaid,” “underlying,” and similar methods. It will be appreciated that a composite or fused image, view, information, or display that can combine or mix images, graphical visual elements, and / or information, etc. that can be present in a single layer or multiple layers can be generated or provided by any of these techniques.
[0178] Any system, device, or method embodiment disclosed herein can involve or include the use of systems, devices, or methods disclosed in, for example, U.S. Patent Publication Nos. 2004 / 0082939, 2012 / 0283557, 2016 / 0095751, and 2017 / 0202708, and U.S. Patent 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, the contents of each of which are incorporated by reference herein.
[0179] Although reference is made to using the indicia displayed on the display to determine the location of the collector channel, the methods and apparatus disclosed herein can be used to mark the eye at a location corresponding to the collector channel prior to surgery. The surgeon can use these marks to make a hole over the Schlemm's canal according to the marks placed on the eye. For example, the eye can be marked with ink to identify a location for preferred surgical treatment, and an opening formed in the trabecular meshwork corresponding to the location for preferred surgical treatment. While the preferred embodiments of the application have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the application. It should be understood that various alternatives to the embodiments of the application described herein can be employed in practicing the application. It is intended that the following claims define the scope of the application and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims
1. A system for treating the eye, comprising: At least one of a microscope or camera system configured to view a microscope image of the anterior segment of the eye, providing an unenhanced view of the eye; An observation device configured to present an enhanced view of the eye to a user, the enhanced view including a view of the eye and an optical coherence tomography (OCT) image of at least a portion of a target tissue region, the OCT image being aligned with an unenhanced view of the eye, the OCT image being capable of identifying a target location located within the target tissue region, the target location being invisible in the unenhanced view of the eye; as well as A probe having a distal end that advances toward the target tissue region within the anterior chamber of the eye, at least one of the distal end of the probe or an implant on the distal end of the probe being initially visible in an unenhanced view of the eye, the distal end of the probe or the implant on the distal end of the probe becoming invisible in the unenhanced view of the eye during advancement toward the target tissue region, the probe also being configured to perform a surgical procedure at the target location when information from the enhanced view regarding the relative position of the distal end of the probe or the implant on the distal end of the probe relative to the target location is visible to the observation device.
2. The system according to claim 1, wherein: The enhanced view includes at least one first graphic visual element representing and identifying the target location, wherein the at least one first graphic visual element is aligned with the unenhanced view of the eye; The enhanced view includes at least one second graphic visual element indicating at least one of the distal end of the probe or an implant on the distal end of the probe, wherein the at least one second graphic visual element is aligned with the unenhanced view of the eye; and When at least one of the distal end of the probe or the implant on the distal end of the probe approaches the target tissue area, the at least one first graphic visual element and the at least one second graphic visual element become visible in the enhanced view.
3. The system according to claim 1, wherein, The enhanced view includes: At least one first graphic visual element representing and identifying the target location, wherein the at least one first graphic visual element is aligned with the unenhanced view of the eye; Identify at least one second graphic visual element of at least one of the distal end of the probe or an implant on the distal end of the probe, wherein the at least one second graphic visual element is aligned with an unenhanced view of the eye; and The relative position of at least one graphic visual element identifying at least one of the distal end of the probe or the implant on the distal end of the probe with respect to at least one graphic visual element representing and identifying the target location is based on the relative position of at least one of the distal end of the probe or the implant on the distal end of the probe with respect to the target location.
4. The system according to claim 1, wherein, The OCT image includes information about at least one of the Schlemm tubes of the eye or the collecting tube system of the eye.
5. The system according to claim 1, wherein: The OCT image includes information about the relative position of at least one of the distal end of the probe or an implant on the distal end of the probe relative to the target location.
6. The system according to claim 5, wherein, The enhanced view includes: At least one first graphic visual element indicating at least one of the distal end of the probe or an implant on the distal end of the probe, and At least one second graphic visual element indicating the surface of the trabecular mesh of the eye, Wherein, the at least one first graphic visual element and the at least one second graphic visual element are aligned with the unenhanced view of the eye, and In the enhanced view, at least one first graphic visual element and at least one second graphic visual element positioned adjacent to each other indicate that at least one of the implants at the distal end of the probe or at the distal end of the probe is in contact with the surface of the trabecular mesh of the eye.
7. The system according to claim 6, wherein, The enhanced view includes: At least one third graphic visual element indicating at least one of the trabecular meshes beside the small tubes of the eye or the Schlemm tubes of the eye. Wherein, the at least one third graphic visual element is aligned with the unenhanced view of the eye, and In the enhanced view, at least one second graphic visual element and at least one third graphic visual element positioned closer to each other than when there is a first contact between the implant on the probe or the distal end of the probe and the surface of the trabecular mesh of the eye are able to determine trabecular mesh compression.
8. The system according to claim 1, wherein, The enhanced view includes: At least one first graphic visual element representing and identifying the target location, wherein the at least one first graphic visual element is aligned with the unenhanced view of the eye; At least one second graphic visual element is indicated on the inner wall of the Schlemm tube of the eye, wherein the at least one second graphic visual element is aligned with the unenhanced view of the eye; and In the enhanced view, at least one second graphic visual element indicating the inner wall of the Schlemm tube of the eye changes to indicate that the inner wall of the Schlemm tube of the eye has been penetrated.
9. The system according to claim 1, wherein, The observation device includes at least one of a display device, a microscope device, a head-up display, an observation monitor, a virtual reality observation device, and an augmented reality observation device.
10. The system according to claim 1, wherein: The target location is determined based on at least one of preoperative OCT images, intraoperative OCT images, preoperative OCT images, and intraoperative OCT images, and is determined by the surgeon. The preoperative OCT image, the intraoperative OCT image, or at least one of the preoperative OCT image and the intraoperative OCT image shows at least one of the Schlemm tubes of the eye or the network of collecting canals of the eye; as well as The target location is determined based on the preoperative OCT image, the intraoperative OCT image, or at least one of the preoperative OCT image and the intraoperative OCT image.
11. The system according to claim 10, wherein, The observation device is configured to overlay one or more guide markers onto at least one of a preoperative OCT image, an intraoperative OCT image, or a preoperative OCT image and an intraoperative OCT image.
12. The system according to claim 1, wherein, The enhanced view also includes the OCT image and at least one graphic visual element that are adjacent to or overlaid on the unenhanced view of the eye.
13. The system according to claim 1, wherein, The OCT image is generated by at least one of the following: a standalone OCT unit, a microscope with an integrated OCT unit, or one or more optical fibers contained in the probe and configured to transmit and receive OCT information.
14. The system according to claim 1, wherein, The probe includes at least one optical fiber configured to transmit photoablation energy sufficient to photoablate tissue in the target tissue region during the surgical procedure.
15. The system according to claim 1, wherein, The unenhanced view is a real-time view and the OCT image is a real-time image.
16. The system of claim 1, further comprising an OCT unit configured to generate the OCT image, wherein, The OCT unit includes at least one of a microscope OCT unit and an optical fiber-based OCT unit.
17. A system for treating the eye, comprising: A probe having a distal end that advances within the anterior chamber of the eye toward a target tissue region within the anterior chamber of the eye; as well as An optical coherence tomography (OCT) unit is configured to perform an OCT scan in the target tissue region within the anterior chamber of the eye to generate an OCT image of at least a portion of the target tissue region during a surgical procedure. The OCT image is aligned with the unenhanced view of the eye. The OCT image is capable of identifying the target location within the target tissue region, wherein the target location is not visible in the unenhanced view of the eye. Wherein, at least one of the distal end of the probe or the implant on the distal end of the probe is initially visible in an unenhanced view of the eye, wherein the distal end of the probe or the implant on the distal end of the probe becomes invisible in the unenhanced view of the eye during advancement toward the target tissue region, wherein the probe is further configured to perform the surgical procedure at the target location when the OCT image includes information about the relative position of the distal end of the probe or the implant on the distal end of the probe relative to the target location.
18. The system of claim 17, further comprising a microscope, wherein, The microscope is configured to present an unenhanced view of the eye, and the OCT unit is integrated with the microscope.
19. The system according to claim 17, wherein, The OCT unit includes one or more optical fibers, wherein the one or more optical fibers are configured to transmit and receive OCT signals, and wherein the one or more optical fibers are at least partially disposed within the probe.
20. The system according to claim 17, wherein, The probe includes at least one optical fiber configured to transmit photoablation energy sufficient to photoablate tissue in the target tissue region during the surgical procedure.
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