Systems, devices and method for use in imaging, diagnosis, evaluation and treatment of an eye

Abstract

A standalone docking system allows a docking suction cup to be accurately aligned and secured in place to a patient's eye. The standalone docking system may then be removed and a treatment system attached. The standalone docking process may be used with a docking process uses OCT imaging of an anterior segment of the eye for the alignment. The OCT imaging docking may be used without the standalone docking. An extendable / retractable rail is provided that can extend a suction cup away from a patient interface in order to provide space for positioning a flatfield OCT module that allows the anterior segment of the eye to be imaged using OCT. Once aligned, the suction cup can be fixed to the eye, the flatfield OCT module removed and the rail retracted. With the rails retracted, the patient interface can be secured to the suction cup attached to the eye.

Description

SYSTEMS, DEVICES AND METHOD FOR USE IN IMAGING, DIAGNOSIS, EVALUATION AND TREATMENT OF AN EYERELATED APPLICATIONS

[0001] The current application claims priority to US Provisional Patent Application 63 / 699,692 filed September 26, 2024 and titled “Docking Systems for an Eye”, US Provisional Patent Application 63 / 699,695 filed September 26, 2024 and titled “OCT VOLUME FLOATER EXTRACTION AND FIRING PLAN GENERATION”, and US Provisional Patent Application 63 / 699,699 filed September 26, 2024 and titled “Systems, Devices and Method For Use In Imaging, Diagnosis and Evaluation and Treatment of an Eye”. The entire contents of each provisional application noted above is incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] The current disclosure relates to treatment systems for the eye, and in particular to laser treatment systems.BACKGROUND

[0003] System integration often introduces technical challenges that can restrict a system's performance across a broader range of applications, substantially increasing its complexity. This issue is particularly evident in refractive surgeries, where a docking process is necessary to stabilize and align the eye to the treatment system. The docking process and features may be integrated into the treatment system. However, the integration of multiple features for docking into a single system limits both the available space and the functional capabilities of the treatment device and / or can increase the complexity of the system.

[0004] Further, limitations in the OCT depth range and scanning mode hinder the ability to obtain a volumetric scan of an eye's anterior segment with the cornea and lens. These constraints prevent the use of anterior OCT for docking and aligning the eye's optical / pupillary axis with a system's optical axis.

[0005] Eye floaters may be treated with a laser. In order to treat the floater, it needs to be identified within the vitreous in order to target the laser. OCT volume captures of thevitreous typically contain very sparse features / voxels even if there is a floater present in the imaged volume. In addition, since floaters themselves are often nearly transparent, amplifying signals in the OCT volumes can result in significant noise. This makes it difficult to convert a 3D volume of voxels into a 3D mesh of an imaged floater with distinct boundaries.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Further features and advantages of the present disclosure will become apparent from the following detailed description, taken in combination with the appended drawings, in which:

[0007] FIG. 1A-1 C depict components of a standalone docking system and process using the standalone docking system.

[0008] FIG. 2 depicts an overhead view components of a standalone docking system.

[0009] FIG. 3 depicts a block diagram of a docking system.

[0010] FIG. 4 depicts a method for aligning and securing a docking suction cup to a patient’s eye.

[0011] FIG. 5 depicts an anterior OCT capable docking system.

[0012] FIG. 6 depicts the anterior OCT capable docking system with an anterior OCT module.

[0013] FIG. 7 depicts the anterior OCT capable docking system with the rails retracted.

[0014] FIG. 8 depicts a method of docking using anterior OCT.

[0015] FIG. 9 depicts a process for generating a laser firing path for a floater.

[0016] FIG. 10 depicts a system and method for generating a laser firing path for a floater.

[0017] FIG. 11 depicts a method for capturing floater data and controlling a laser based on the floater data.

[0018] FIGS. 12 and 13 depict example interfaces of a web portal.DETAILED DESCRIPTION

[0019] In accordance with the present disclosure, there is provided a docking system comprising: a support arm securable at a location relative to a patient’s eye; and a standalone docking system that is moveable into position relative to the support arm, the docking system comprising: fine adjustment mechanism for aligning a patient interface module and docking suction cup to the patient’s eye; and an imaging system for use in aligning the patient interface and docking suction cup, wherein the support arm is adapted to securely hold the docking suction cup in position once aligned.

[0020] In a further embodiment of the docking system, the standalone docking system further comprises: a retractable rail adapted to secure the suction cup at an end, the rail moveable between a first position in which the suction cup can be secured to the patient interface and a second position in which a space is provided between the suction cup and the patient interface; and a flatfield OCT module insertable into the space between the suction cup and the PI with the retractable rail in the second position.

[0021] In a further embodiment of the docking system, the patient interface and docking suction cup are detachable from the standalone docking system.

[0022] In a further embodiment of the docking system, the patient interface is detachable from the docking suction cup.

[0023] In a further embodiment of the docking system, the standalone docking system is moveable away from the patient eye while the docking suction cup remains secured in position on the patient’s eye.

[0024] In a further embodiment of the docking system, the imaging system comprises one or more of: a docking camera; and an optical coherence tomography (OCT) imaging system.

[0025] In accordance with the present disclosure, there is further provided a method for docking a treatment device to an eye, the method comprising: securing a suction cupsupport arm in position relative to a patient’s eye; moving a standalone docking system with a detachable patient interface into position relative to the patient’s eye; aligning a docking suction cup secured to the detachable patient interface using alignment components of the standalone docking system; once aligned, securing the docking suction cup to the patient’s eye; securing the docking suction cup in place with the suction support arm; removing the standalone docking system; and securing a treatment system to the patent’s eye using the aligned docking suction cup.

[0026] In accordance with the present disclosure, there is further provided a docking system comprising: a patient interface module; a retractable rail adapted to secure a suction cup at an end, the rail moveable between a first position in which the suction cup can be secured to the patient interface and a second position in which a space is provided between the suction cup and the patient interface; and a flatfield OCT module insertable into the space between the suction cup and the PI with the retractable rail in the second position.

[0027] In a further embodiment of the docking system, the docking system further comprises: a guiding mechanism for adjusting an alignment of the patient interface and suction cup relative to the eye.

[0028] In a further embodiment of the docking system, the alignment is performed based on at least OCT imaging of an anterior segment of the eye when the flatfield OCT module is positioned between the suction cup and the PI.

[0029] In a further embodiment of the docking system, the docking system further comprises a suction pump connected to the suction cup to provide suction to secure the suction cup to the eye.

[0030] In accordance with the present disclosure, there is further provided a method of docking a system to an eye, the method comprising: extending a rail holding a suction cup away from a patient interface towards the eye; position a flatfield OCT module in a space between the suction cup and the patient interface; aligning the patient interface and suction cup to the eye using OCT imaging of an anterior segment of the eye;removing the flatfield OCT module from the space between the suction cup and the patient interface; and retracting the rail and securing the patient interface to the suction cup.

[0031] In accordance with the present disclosure, there is further provided a method of generating a firing path for treatment of a floater, the method comprising: receiving 3D OCT scan data comprising a plurality of voxels captured from a vitreous of a patient; performing 3D clustering of the voxels of the received 3D OCT scan data; generating a 3D mesh from the voxels of at least one of the clusters of voxels, the 3D mesh associated with at least a portion of a floater; and generating a laser firing plan using the generated 3D mesh for treating the floater.

[0032] In a further embodiment of the method, the clustering of the voxels uses k-means clustering.

[0033] In a further embodiment of the method, the 3D mesh is generated using a convex hull algorithm.

[0034] In accordance with the present disclosure, there is further provided a system for use in generating a firing path for treatment of a floater, the system comprising: a processor for executing instructions; and a memory storing instructions, which when executed by the processor configure the system to perform a method according to any of the methods of generating a firing path described above

[0035] In accordance with the present disclosure, there is further provided a non-transitory computer readable memory storing instructions, which when executed by a processor of a system configure the system to perform a method according to any of the methods of generating a firing path described above

[0036] In various eye treatments, particularly those using a laser system for treatment and / or imaging, the treatment system should be precisely aligned with the patient’s eye and the relative position between the eye and the treatment system fixed. A patient interface can be docked to the patient’s eye and the treatment system fixed to the patientinterface. In order to provide a flexible docking procedure, the a docking device may be provided that is separate from the treatment system.

[0037] A standalone docking and treatment system may a standalone docking device dedicated to performing the docking procedure and a separate treatment system. Once the docking procedure is complete, the standalone docking device can be removed and the treatment system brought in. Separating the docking process and devices from the treatment devices may significantly reduce system complexity while providing greater operational flexibility. The standalone docking system and process described herein may be of particular use with refractive surgeries on the posterior chamber of the eye, refractive surgeries on the anterior chamber of the eye, eye procedures that includes docking system for either human or animal studies, among other uses.

[0038] The standalone docking system uses a docking suction cup module designed to secure to the patient’s eye via suction. This docking suction cup module can be secured to a patient interface (PI) and the patient interface can be secured to the docking device or a treatment system device. The patient interface may include various mechanisms for securing to the docking device or treatment system. For example, the patient interface may include a self-centering mechanism with a magnetic lock in order to secure the docking suction cup to the PI of the docking system or to other systems such as a treatment system. Other physical interfaces may be provided between the patient interface and the docking device as well as the treatment system. The patient interface may be mounted on a moveable chassis or structure of the docking device that also supports one or more optical systems that can be used in aligning the docking suction cup to the eye.

[0039] The optical system may include optical telescope system with two or more optical inputs. One input integrates a docking camera for perpendicular visualization of the patient's eye and aberrometry. The other input may integrate an anterior optical coherence tomography (OCT) system that can be used for scanning the eye and generating a 3D model. It will be appreciated that other imaging devices may be incorporated into the moveable chassis of the docking device. The docking device mayinclude a precisely movable structure that provides at least three degrees of freedom in the positioning of the patient interface , allowing precise control and guidance of the patient interface towards the eye, for example via a lead screw or electrically actuated mechanism. While three degrees of freedom are described, the docking device may provide controlled movement of the patient interface in more than three degrees of freedom.

[0040] Additionally, a movable suction cup support arm, may be provided to support the docking suction cup, prior to affixing to the patient’s eye. The support arm may be fixed to an operational table or other support structure. The moveable suction cup support arm may be attached to the docking suction cup prior to the docking procedure, or during the docking procedure. The suction cup support arm may incorporate an interface for connecting the suction and any fluid lines from the suction cup. The fluid lines may be connected to a fluid pump system that may be part of the docking device, or provided separately from the docking device. The support arm may be moveable along one or more degrees of freedom to allow positioning and adjustment of the suction cup relative to the patient’s eye. The movement of the support arm may be restricted in order to secure the support arm and the suction cup in a fixed position.

[0041] The docking procedure may begin by securing the suction cup support arm to the operational table if not already in place. A patient may be seated, or in other positions such as lying on their stomach, side, or back in a position that allows the suction cup support arm to be moved close to the patient’s eye. A docking suction cup may be attached to the support arm prior to the docking procedure or may be secured to the support arm during the docking procedure. Regardless of when the suction cup is secured to the support arm, it is brought into contact with the eye during the docking procedure. The support arm may be adjusted in multiple degrees of freedom to position the suction cup in a desired position and orientation relative to the patient’s eye. The standalone docking device is then maneuvered into position and aligned with the eye using the system’s alignment features such as the docking camera and OCT imaging system. Moving the docking device into position may include a coarse movement in which the docking device is rolled, rotated, slid, etc. into close proximity of the patient, and afine position movement in which a moveable frame of the docking device that supports the patient interface and alignment optics can be precisely moved along one or more degrees of freedom. The patient interface may be secured to the suction cup. Once the desired alignment is achieved, suction is applied to the docking suction cup, and fluids may be introduced. Once the suction cup is suctioned on the eye and held securely in place by the support arm, the patient interface mechanism securing the suction cup with the standalone docking device is released from the docking device. The standalone docking system is then removed, and the treatment system can be positioned and connected to complete the docking process of the treatment system. The patient interface provides a mechanism for fixedly connecting, in a releasable manner, both the docking device and the treatment system. With the suction cup and patient interface secured to the eye in the desired orientation using the docking device, the patient interface can be released from the docking device and the treatment system secured to the patient interface in order to locate the treatment system in a fixed relation relative to the patient’s eye.

[0042] FIGS. 1A-1 C depict components of a standalone docking system and process using the standalone docking system. FIG. 2 depicts components of the standalone docking system in an overhead view. The standalone docking process allows a docking suction cup to be secured to a patient’s 102 eye 104. The docking process uses a separate docking device 104 in order to align and secure a docking suction cup 106 in place. Once secured in place, the standalone docking device 104 can be removed and a treatment system 122 (see FIG. 1 C) attached or otherwise secured to the eye via the docking suction cup. As depicted in FIG. 1 A the overall docking system includes a support arm 108a, 108b that may be secured to an operating table or other structure. The support arm includes a mounting mechanism for holding a docking suction cup 106. The support arm may be able to both allow movement of the suction cup in order to allow alignment on the eye as well as securely hold the suction cup in position. That is, the support arm may be freely moved to position the suction cup and then locked in place. This is depicted in FIGs. 1A-1 C in which the support arm 108a is depicted in an unlocked position and support arm 108b is depicted in a locked position in which the arm securely holds the suction cup in position. As depicted in FIG. 1A the patient may be placed in position, andsupport arm and suction cup placed in a general position. The support arm may have a number of degrees of freedom in order to allow it to be positioned as required. Once the patient and support arm are in position, the standalone docking device 104 may be moved into place.

[0043] The standalone docking device 104 may be provided as a cart or other structure that can be rolled, swung or otherwise brought into the general area, as depicted in FIG. 1 B. The standalone docking system 104 may be mounted on a moveable platform 110, or may have multiple movable platforms that provides multiple degrees of freedom in order to move the docking system into position. A patient interface (PI) 112 may be connected to the docking system 104. The PI 112 may have features to allow the PI to be connected and secured to the docking suction cup 106. Alternatively, the patient interface may be provided with the docking suction cup. The docking system may also include fine adjustment mechanisms 124a, 124b that allow the fine positioning and alignment of the PI, and the suction cup when connected, relative to the patient’s eye. The fine adjustments may be provided manually such as using lead screws with handwheels or electric controls. The fine adjustments may also be performed automatically or semi-automatically. The docking system 104 may further include various components for facilitating the fine alignment, including for example a docking camera 114, an OCT imaging system 116 and lighting, filtering, and focussing components 118.

[0044] Once the PI and docking suction cup are properly aligned, the suction cup can be secured to the eye via suction and the suction cup can be securely held by the support arm 108b as depicted in FIG. 1 C. With the docking suction cup 106 secured in position, the standalone docking system can be detached and moved out of the area 12. As depicted in FIG. 1 C, a treatment system 120 may then be brought into position and secured to the eye via the suction cup 106. The treatment system may have coarse positioning and fine positioning systems. For example, the coarse positioning may comprise wheels or casters that allow the treatment system to be moved into the genera location. The fine positioning system may comprises lead screws with handwheels 126a, 126b, or other positioning mechanisms. The treatment system, once positioned may be secured to the suction cup in a similar manner as the docking system. For example, thePI of the docking system 104 may be detached from the docking system and kept with suction cup. The treatment system 120 may then be secured to the P1 112 that is attached to the suction cup. Alternatively, the PI 112 may be detached from the suction cup and then a similar patient interface on the treatment system 122 may be secured to the suction cup.

[0045] FIG. 3 depicts a schematic representation of the docking device and support arm. As depicted the suction cup support arm 302 is mounted on a table 304 or other support structure. The support arm has a suction cup support 306 that can hold a suction cup, and / or the patient interface, during the docking. The suction cup support can be moved along several degrees of freedom in order to align with the patient’s eye. A docking device 308 is depicted as having a table or other structure 310 mounted on wheels 312 that allow the docking device to be rolled in to position and out of the way to allow the treatment system (not shown) to be moved into position. The docking device 308 has fine adjustment positioning mechanism or mechanisms (not shown) that allows the docking point 314 to be moved along multiple degrees of freedom in order to align with the suction cup in the suction cup support. The optics and other devices such as the camera and OCT system are not depicted in FIG. 3 however, the may be mounted on the docking device.

[0046] FIG. 4 depicts a method for aligning and securing a docking suction cup to a patient’s eye. The method 400 begins with securing a suction cup support arm in position (402). The support arm is secured in the vicinity of the eye and can allow a suction cup to be positioned on the eye. A standalone docking system with a detachable patient interface is moved into position (404) in order to align the placement of the suction cup on the eye. The docking suction cup is aligned using the features of the standalone docking system (406) which may include for example one or more camera or imaging systems. During alignment, the patient interface may be connected to the docking suction cup so that movement of the patient interface also moves the suction cup. Once aligned, the suction cup is secured to the eye (408) for example using suction. The suction cup can then be secured in place by the support arm (410). The support arm may be fixed in position in order to securely hold the suction cup. The standalone docking system canthen be detached and removed (412). The docking system may be detached by releasing the patient interface from the docking system while the patient interface remains secured to the docking suction cup, or the docking system may be detached by releasing the patient interface from the suction cup. Regardless, once moved out of the way, a treatment system can be connected or otherwise secured to the eye using the suction cup (414).

[0047] The standalone docking system described above provides a standalone docking system that can align the docking suction cup and then move out of the way to allow a treatment system to be used with the aligned docking suction cup. In this way, the treatment system does not need to incorporate components for performing the docking process which can provide flexibility in the docking process as well as possibly simplifying the design of the docking components and / or the treatment device.

[0048] The above has described a standalone docking system and process. The standalone docking system may be used with an anterior OCT imaging docking process in which OCT imaging of an anterior segment of the eye is possible. The anterior OCT imaging of the eye can be used in order to accurately position and align the optical systems in the docking system, and so the treatment system once attached to the patient interface, during docking of the patient interface. Additionally, it is possible for the anterior OCT imaging docking process to be used without the standalone docking system.

[0049] It can be desirable to use anterior OCT imaging, that is OCT imaging of the anterior segment, such as the cornea and or lens, of the eye for docking and aligning the eye’s optical / pupillary axis with a system’s optical axis. In order to do so, a retractable rail is used to extend a docking suction cup away from a patient interface component. A flatfield OCT module can be placed in the space between the docking suction cup and the patient interface component in order to allow the anterior segment of the eye to be imaged using OCT. The anterior OCT imaging can then be used to align the patient interface and docking suction cup the to the patient’s eye. Once aligned, the suction cup can be secured to the eye, for example by suction, and then the flatfield OCT module removed and the rails retracted so that the patient interface can be secured to the suction cup. Theanterior OCT imaging based docking process can be combined with the standalone docking process and system described above, or may be used with a docking system the is part of the treatment system.

[0050] A docking process is depicted in FIGs. 5 - 7 in which the docking and treatment systems are combined together. In order to use anterior imaging, a different physical arrangement of the eye relative to the imaging system may be required compared to the treatment system. This differing distance during docking and treatment is possible in the above docking system since the docking device and treatment system are separated. As described further below, a docking and treatment system can be combined together. The docking system comprises a pair of rails that can extend in order to allow fitting of a lens or lenses required for anterior OCT imaging and then retract in order to perform regular OCT imaging.

[0051] FIG. 5 depicts the anterior OCT docking system with extended rails. FIG. 6 depicts the docking system with the flatfield OCT module in place to allow the OCT imaging of the anterior segment of the eye. FIG. 7 depicts the docking system with the flatfield OCT module removed and the rails retracted in order to attach the patient interface module to the suction cup.

[0052] The docking system includes a Patient Interface (PI) module 502, a retractable rail 504, a suction cup module 506, a Flatfield OCT Lens Module 508, and a guiding mechanism 510. The PI module 502 facilitates interaction between various components for the docking procedure and features a magnetic reference point for precise alignment of the PI module and other components. This allows for the accurate placement of modules, including the suction cup relative to the PI module 502, which may be secured in a known orientation within a system such as a treatment and / or imaging system.

[0053] The retractable rail 504 holds and guides the suction cup module 506 to the patient’s eye. The rails can also support and align the Flatfield Anterior OCT module 508 with the patient's eye 512 and other components of the docking system. The Flatfield OCT module 508 can be easily installed and removed via a self-locating mechanism. The suction cup module enables secure attachment to the patient's eye using suction.

[0054] The system operates with a Patient Interface (PI) 502 held by a fixed rail with an extendable arm rail 504 as seen clearly in FIGs. 5 and 6. This extendable arm rail 504 secures the suction cup module 506, ensuring perpendicularity and alignment between the system's optical axis and the suction cup's main axis. When the Flatfield Anterior OCT module 508 is needed, a mechanism extends the extendable arm rail as depicted in FIGs. 5 and 6, allowing the module 508 to be inserted between the system’s optical elements and the suction cup as depicted in FIG. 6. The rail can then retract, settling the module 508 in place for use. Once docking and alignment is complete and suction is activated to secure the suction cup in place on the eye, the Flatfield Anterior OCT module 508 can be removed, and the rail is retracted, causing the device with the patient interface 502 to move toward the eye until the suction cup module 506 attaches to the patient interface 502.

[0055] FIG. 8 depicts a docking method using OCT imaging of the anterior segment of the eye. The method 800 begins with extending a rail holding a suction cup away from a patient interface (PI) toward the eye (802). Extending the rail and suction cup creates a space between the PI and the suction cup in which a flatfield OCT module can be positioned (804). With the flatfield OCT module in place, OCT imaging of the anterior segment of the eye is possible and so the anterior OCT imaging of the eye can then be used for the docking alignment of the patient interface, suction cup and eye (806). Once aligned, the suction cup can be secured to the eye by applying suction and then the flatfield OCT module can be removed (808). With the flatfield OCT module removed, the rail can be retracted and the PI secured to the suction cup (810), which in turn is secured to the patient’s eye.

[0056] The above docking systems allow a treatment device to be precisely aligned and secured to a patient's eye, which may be particularly important for treating one or more ophthalmological conditions with a laser. The ophthalmological conditions may include for example, diabetic retinopathy, age-related macular degeneration, vitreomacular traction, tears, retinal detachments, holes, glaucoma, vein occlusion, choroidal detachment, diabetic macular edema, posterior vitreous detachment, cataract, and floaters.

[0057] In order to treat floaters, also referred to as symptomatic vitreous opacities (SVOs), with a laser, a 3D mask, or mesh of the floater can be used to generate a treatment plan and laser firing path. The firing path may be a path or list of firing point coordinates. The treatment plan may include the firing path as well as other information such as laser power levels, pulse durations, number of firings, etc. along the firing path. It is possible to include the laser power levels pulse durations, number of firings, etc. as part of the firing path rather than as part of the treatment plan.

[0058] While a treatment plan and firing path can be generated from the 3D mask or mesh corresponding to the floater, generating the 3D mask or mesh can be difficult. OCT (Optical Coherence Tomography) volume captures of the vitreous typically contain very sparse features / voxels even if there is a floater present in the imaged volume. As described herein, in order to generate a 3D mask or mesh of a floater from the OCT volume captures, the current process statistically identifies clusters of voxels in a 3D OCT volume and then determines which of these clusters can be combined into a single floater geometry.

[0059] FIG. 9 depicts a process for generating a laser firing path for a floater. The process begins with capturing a 3D OCT volume 902. The 3D OCT volume 902 may be captured as a plurality of slices captured from an OCT imaging device. The 3D OCT volume can be processed in order to cluster voxels together 904. The clustering may be performed using various clustering techniques, including for example k-means clustering. With the voxel clusters identified, one or more can be combined into a single floater geometry, which may be provided as a 3D mask or mesh 906. The 3D mesh can be generated from a set of identified clusters using various techniques including for example a convex hull algorithm. It is possible to generate multiple 3D meshes by combining different clusters of voxels together using the convex hull algorithm. In such case, the resulting meshes can be evaluated to select a 3D mesh as the representation of the floater. Once the floaters 3D mesh is created, a corresponding treatment plan with a firing path 908 can be generated. The firing path provides a plurality of laser target locations on the 3D mesh of the floater, which are arranged to ablate, break apart or otherwise reduce the impact of the floater on the patient’s vision.

[0060] FIG. 10 depicts a system and method for generating a laser firing path for a floater. The processing for generating the treatment plan and firing path is depicted as being performed by one or more servers 1002 or computers. It will be appreciated that the processing may be performed by one or more computing devices that are communicatively coupled together by one or more networks. The one or more servers include one or more processors 1004 and memory units 1006. The servers may also include one or more Graphic Processing Units (GPUs) 1008, or other specialized components for efficiently executing required calculations. The servers may also include one or more input / output (I / O) interfaces 1010 which may be used to connect one or more other computing devices, including for example network interfaces, displays, keyboards and mice, etc. to the one or more servers. The memory units 1006 of the server include instructions which when executed by the processors 1004, and other processing units such as the GPUs 1008, configure the one or more servers to perform various functionality including the firing path generation functionality 1012. The treatment plan and firing path may be generated in real-time or near real-time during a treatment procedure. Additionally or alternatively, the treatment plan and firing path may be generated after capturing the OCT volume data and before the treatment procedure.

[0061] The firing path generation functionality 1012 receives 3D OCT scan data (1014), and performs 3D clustering (1016).

[0062] The clustering process may include processing of the OCT scan data to motion correct the data to account for eye movement. The corrected OCT data can then be max projected in the x and y axes and then thresholded to form a mask. Point clusters can be detected from the mask using a clustering algorithm such as k-means, HDBSCAN (Hierarchical Density-Based Spatial Clustering of Applications with Noise), or other clustering techniques. For HDBSCAN, the hierarchical clustering may cluster the points, and then points within clusters are filtered to remove points with low probability of belonging in the cluster. Clusters can be filtered by minimum size requirements. All non- noisy clusters above the retina z-depth are labeled floaters and all clusters below are labeled as retina.

[0063] The floater clusters can be combined together in various ways. For example, a bounding box is drawn around every detected floater in both the x and y max projections. Once coordinates for bounding boxes are found in x and y, they are matched to each other using a threshold in the z direction and a difference in z-length. Matched bounding boxes form a bounding cube, while non-matched boxes are ignored. Using generated floater coordinates generated from the last step, the OCT is cropped to the bounding cubes’ dimensions and thresholded to form a 3-D mask.

[0064] HDBSCAN can be applied again to the 3D mask and points within clusters are filtered to remove points with low probability of belonging in the cluster. The largest cluster in the bounded OCT cube is taken as the floater and isolated from the other points.

[0065] Based on the clustering process a 3D mesh of one or more clusters may generated (218) The 3D mesh for the floater can be generated as an alpha shape mesh from the isolated floater and holes in the mesh are corrected. Once the floater’s 3D mesh is generated a firing plan can be generated for the 3D mesh (1020).

[0066] The ability to identify and target a floater and then control a laser in order to ablate the floater can be demonstrated as described below.

[0067] The treatment device is able to image an eye using multiple imaging modalities such as SVO and OCT imaging. The treatment device may include a laser capable of targeting locations within a volume such as the eye or other targets.

[0068] In order to evaluate and demonstrate the effectiveness of the treatment system, floater data from a patient was captured and then etched into an acrylic ball representation of an eye. As depicted in FIG. 11 , the process 1100 includes capturing floater data (1102) which can then be etched into acrylic in order to demonstrate the ability to identify a floater and control a laser based on the floater (1104). The etching includes preparing a setting up a treatment laser device (TxF) (1106), ablating the acrylic sample with the laser controlled based on the floater (1108), and then retrieving the acrylic sample.

[0069] Although referred to as a treatment system, it may also be used for imaging the eye. The treatment system may be a multimodal imaging platform and can be used toimage an eye with a floater, or SVO. The treatment system can capture OCT and SLO images. The captures can be processed to identify a 3D capture with a floater suitable for etching into the acrylic. For example, the floater should preferably be dense and oriented primarily laterally with a size of about 2x2 to 3x3 mm2. Preferably, the axial depth of the floater is no greater than about 1 mm. Once the floater is identified, the capture volume file for the selected floater can be retrieved.

[0070] When etching the floater onto the acrylic sample, or possibly other materials, an STL file can be generated from the floater capture volume file, the fire electronics and treatment laser device can be programmed in order to etch the floater onto the acrylic sample. Once programmed, the laser can be fired in order to etch the floater onto the acrylic.

[0071] Generating the STL data from the floater capture volume file may include identifying a bounding cube for the floater from the OCT; isolating the floater from the noise within the bounding cube; and generating a triangular mesh, or other mesh structure, from the floater.

[0072] The OCT may be motion corrected to account for eye movement that occurred during scanning. The motion corrected OCT can then be max projected in the x and y axes and thresholded to form a mask. Point clusters are detected from the mask using a clustering algorithm such as Hierarchical Density-Based Spatial Clustering of Applications with Noise (HDBSCAN). Points within clusters are filtered to remove points with low probability of belonging in the cluster and clusters are filtered by minimum size requirements. All non-noisy clusters above the retina z-depth, which may be generated from motion correction, are labeled floaters and all clusters below are labeled as retina. A bounding box is drawn around every detected floater in both the x and y max projections. Once coordinates for bounding boxes are found in x and y, they are matched to each other using a threshold in the z direction and a difference in z-length. Matched bounding boxes form a bounding cube, while non-matched boxes are ignored. Using generated floater coordinates generated from the last step, the OCT is cropped to the bounding cubes’ dimensions and thresholded to form a 3-D mask. HDBSCAN is appliedagain and points within clusters are filtered to remove points with low probability of belonging in the cluster. The largest cluster in the bounded OCT cube is taken as the floater and isolated from the other points.An alpha shape mesh can be generated from the isolated floater and holes in the mesh corrected. A son file, or other file type, may be returned with mesh faces and vertices.

[0073] Configuring the fire electronics, whether for etching the acrylic or actually treating the floaters in a patient’s eye, may comprise slicing the floater STL data; calibrating the electronics; and firing the slices.

[0074] Once the floater is provided to the electronics as a trimesh file, it can be converted to an STL and sliced vertically into the desired number of slices. Each slice is converted to a convex contour. Each contour is then overlaid onto the raster scan pattern and snapped to an n by n grid, where n is the number of rows in the raster. Using this overlay the raster-contour is traversed and a normalized firing schedule generated. The normalized firing schedule may in the form of coordinate pairs, where the coordinate are on the n by n grid.

[0075] The OCT is then configured to perform a free form scan, where the file used is a raster pattern with n rows. Once the fire electronics have been calibrated and synchronized with the OCT raster scan pattern and the optotune, which is a deformable lens, has been configured with the appropriate analog ranges, the volume is ready to be etched, or the patient’s eye treated.

[0076] The acrylic sample can be placed in the treatment laser test vessel such that it is perpendicular to the firing axis of the femtosecond laser, and within the optotune range that will be scanned during the volume fire. This can be as simple as placing the acrylic so that it covers the entire spinview, which is a side viewing high speed camera, FOV. After the electronics are prepared, and the acrylic sample is placed in the test vessel, the schedule can be loaded into the volume fire GUI and visualized to ensure the schedule was generated correctly. Once verified, the firing schedule can be performed in order to etch the floater shape into the acrylic. Once the firing schedule has been visually verified, the femtosecond laser can be controlled to fire and etch the volume. Immediately eachslice of the floater should be etched into the acrylic by the laser. After some number of surfaces, some dark spots may form and may be viewable by the spinview camera. Once the volume firing is complete, the acrylic sample may be removed from the test vessel and should have a floater etched into it that is clearly visible and resemble the selected floater.

[0077] The above etching process provides a means for verifying that the floater data can be successfully captured and used to control firing of the femtosecond treatment laser. A similar process can be used during the actual treatment of the patient’s eye. However, the system is first docked to the patient’s eye so that the precise position of the patient’s eye, and so the floaters within it, relative to the treatment system is controlled. The treatment laser can be controlled to focus on the floaters in the patient’s eye according to the firing schedule and ablate the floater.

[0078] The above has described a treatment device capable of imaging and laser treatment. It is possible to separate the imaging device and the treatment device. Various systems, devices, and methods are described below which may be used in the imaging, diagnosis, evaluation and / or treatment of an eye. An imaging device for the eye may include both SLO and OCT imaging systems, and may be referred to further below as SVO-ID. A cloud-based or web-based portal, which may be referred to below as CloudPortal, can be provided for storing, visualizing, and processing data collected by devices including the SVO-ID. A feasibility study system (FSS) includes a femtosecond laser. An OCT imaging device (OEM OCT) is used for imaging of the eye. Atreatment laser device (TxF) can be used for planning and executing a test treatment firing pattern in a target medium using a femtosecond laser.

[0079] Turning first to SVO-ID, the SVO-ID comprises hardware and software. The SVO- ID can image an eye, or a fake eye. The hardware provides a combination of SLO and OCT imaging modalities and also provides fixation targets and controls and DPS. The hardware and software can operate with a fake eye or a real eye. Use of the fake eye allows a controlled environment to evaluate and / or demonstrate the system without needing an actual patient.

[0080] The system may include an alignment process, for example using pupil alignment mode. The alignment mode uses various alignment indicators and captures a reference image. The retina can be automatically found during the SLO referencing. The retina calibration allows for click-to-focus for the OCT. The SVO-ID may use machine learning (ML) detections and tracking of floaters which may be performed using the fake floater model. The system may have different capture methods, including ML capture which can skew the scan for motion correction, standard capture of stationary floaters and SLO-only I Full Field capture. The system can synchronize the OCT and SLO systems for the captures. The same processes for alignment and image capture can be performed using a fake eye model as well as a real eye with a human subject.

[0081] Turning next to CloudPortal, which is a web-based portal for storing processing and visualizing data collected by devices such as SVO-ID or other imaging devices. FIGs. 12 and 13 depict example interfaces of the CloudPortal web portal. CloudPortal serves as a visualization tool and can also provide functionality for the diagnostic device and as a planning tool in the treatment device. CloudPortal can show the recently taken data, which may include previously captured data as well as recent data.

[0082] CloudPortal can also show captured floaters. It can store, and display SVO data and can provide a large SVO data set. These SVO captures allow for training of better ML tracking of floaters / SVOs. The dataset may include a formalization of floater characteristics and identify classifications of SVOs. The SVO dataset may also allow for the understanding of the fraction of symptomatic floaters that can be treated by the SVO- ID or similar devices as well as identifying potential patients for treatment.

[0083] Turning next to the feasibility study system, the FSS is a system similar to SVO-ID but with a femtosecond laser. The system may use a dockable test vessel with a plastic retina SLO target or may be docked to a patient’s eye. A syringe, or other possibly automated system, can be used for filling a front chamber between lenses with water or other liquid. A functioning docking box can be accessible through software that provides control / display of various features including: a laser crosshair, a docking cone; suction, force sensors, docking fluid syringe, purkinje illumination, floodlight illumination, anddocking camera. The FSS has a functioning SLO through software. The PC and SLO can be powered on & scanning, chassis brakes are removed & wheels unlocked. The Docking Camera and Optotune Drivers are powered & connected.

[0084] The FSS can go through coarse docking, then fine docking. The coarse docking can include displaying a laser cross hair and moving the system, and / or the patient of fake eye, until located as desired. The system may be locked in place and the crosshairs removed or turned off. A docking cone, including a suction cup may be installed and the system prepared for fine docking. The fine docking may use Purkinje & floodlighting to illuminate and capture the docking camera image. The position of the docking cone can be precisely controlled using for example hand screws or other mechanisms. The docking cone can be moved to contact the eye, and force sensors may be used to determine when contact is made. The Purkinje reflections may be used in the alignment of the docking cone. Once contact is made, and the docking cone is in the desired position, suction can be applied to secure the docking cone to the eye. Once suction is applied, a docking media can be applied. A docking image can be captured from a docking camera and the Purkinje and floodlight illumination turned off. If the SLO path was blocked, it can be unblocked and imaging and / or treatment performed. With the coarse and fine alignment performed, the SLO imaging can be performed. It is possible to adjust SLO Optotune, gain, contrast parameters. Reference SLO images can be captured. The FSS can include a femtosecond laser and a Femtosecond Safety System.

[0085] The FSS with femtosecond laser may be similar to the SVO-ID systems in that it includes SLO and OCT subsystems, but it further includes a femtosecond treatment laser. The femtosecond laser may be used to target and ablate, or remove, floaters from the eye.

[0086] The FSS may be used to determine the safety of the docking system, and its effects on eyes as well as to determine the behavior of the femtosecond treatment laser in the eye through focusing the laser at various points in the eye, which can be adjusted through another tunable lens that is in the femtosecond laser path to determine photoionization thresholds in the vitreous and damage thresholds on the retina.

[0087] The FSS has been used in trials on pigs, which were conducted on 5 pigs, which ended up being 10 sets of eyes each with unique datasets. The test can test and / or verify specific parameters such as using the tunable lens to use photoionization points to see the correlation between the settings on the tunable lens and where they are positioned in the vitreous, which may be important for treating floaters. Titrating the femtosecond power through histology points in the retina and analyzing through taking slices of the eye afterwards can identify the nature of damage from various power levels.

[0088] Turning next to an OCT imaging device (OEM OCT), the OEM OCT, and user interface, can provide various imaging functionality. The OEM OCT can perform 2D b- scans. The OEM OCT can achieve a synchronization in the hardware. The OEM OCT can provide various advantages including faster scan setup, an open platform, integration to femtosecond lasers, integration to safety, and unique scanning / firing algorithm. The OEM OCT can also provide ultra-fast 3D scanning, live 3D scanning and femto fire, and Integration with SLO. The system can capture a 3D volume.

[0089] Turning next to Treatment laser device (TxF), the TxF includes a test vessel in front of the FSS. Cellulose samples can be pre-loaded into holders. The FSS can image the samples using SLO image and OCT imaging. The FSS is able to obtain “real-time” 3D information on the sample. The test vessel is similar to porcine eye, with an open tank, and high speed imaging through the side. The FSS can be used to ablate a region of the sample according to a pattern such as a square or spiral. The results, which will be ablated regions of the sample, can be shown on the SLO and OCT volume.

[0090] It will be appreciated by one of ordinary skill in the art that the system and components shown in FIGS. 1 - 13 may include components and / or steps not shown in the drawings. For simplicity and clarity of the illustration, elements in the figures are not necessarily to scale, are only schematic and are non-limiting of the elements and structures. It will be apparent to persons skilled in the art that a number of variations and modifications can be made without departing from the scope of the invention as defined in the claims.

[0091] Although certain components and steps have been described, it is contemplated that individually described components, as well as steps, may be combined together into fewer components or steps or the steps may be performed sequentially, non-sequentially or concurrently. One or more features, components, and / or elements may be described with reference to a particular embodiment. Such features, components and / or elements can be incorporated into and / or combined with other embodiments. Further, although described above as occurring in a particular order, one of ordinary skill in the art having regard to the current teachings will appreciate that the particular order of certain steps relative to other steps may be changed. Similarly, individual components or steps may be provided by a plurality of components or steps. One of ordinary skill in the art having regard to the current teachings will appreciate that the components and processes described herein may be provided by various combinations of software, firmware and / or hardware, other than the specific implementations described herein as illustrative examples.

[0092] The techniques of various embodiments may be implemented using software, hardware and / or a combination of software and hardware. Various embodiments are directed to apparatus, e.g. a node which may be used in a communications system or data storage system. Various embodiments are also directed to non-transitory machine, e.g., computer, readable medium, e.g., ROM, RAM, CDs, hard discs, etc., which include machine readable instructions for controlling a machine, e.g., processor to implement one, more or all of the steps of the described method or methods.

[0093] Numerous additional variations on the methods and apparatus of the various embodiments described above will be apparent to those skilled in the art in view of the above description. Such variations are to be considered within the scope of the current disclosure.

Claims

WHAT IS CLAIMED IS:1 . A docking system comprising: a support arm securable at a location relative to a patient’s eye; and a standalone docking system that is moveable into position relative to the support arm, the docking system comprising: fine adjustment mechanism for aligning a patient interface module and docking suction cup to the patient’s eye; and an imaging system for use in aligning the patient interface and docking suction cup, wherein the support arm is adapted to securely hold the docking suction cup in position once aligned.

2. The docking system of clam 1 , wherein the standalone docking system further comprises: a retractable rail adapted to secure the suction cup at an end, the rail moveable between a first position in which the suction cup can be secured to the patient interface and a second position in which a space is provided between the suction cup and the patient interface; and a flatfield OCT module insertable into the space between the suction cup and the PI with the retractable rail in the second position.

3. The docking system of claim 1 or 2, wherein the patient interface and docking suction cup are detachable from the standalone docking system.

4. The docking system of claim 1 or 2, wherein the patient interface is detachable from the docking suction cup.

5. The docking system of any one of claims 1 to 4, wherein the standalone docking system is moveable away from the patient eye while the docking suction cup remains secured in position on the patient’s eye.

6. The docking system of any one of claims 1 to 5, wherein the imaging system comprises one or more of: a docking camera; and an optical coherence tomography (OCT) imaging system.

7. A method for docking a treatment device to an eye, the method comprising: securing a suction cup support arm in position relative to a patient’s eye; moving a standalone docking system with a detachable patient interface into position relative to the patient’s eye; aligning a docking suction cup secured to the detachable patient interface using alignment components of the standalone docking system; once aligned, securing the docking suction cup to the patient’s eye; securing the docking suction cup in place with the suction support arm; removing the standalone docking system; and securing a treatment system to the patent’s eye using the aligned docking suction cup.

8. A docking system comprising: a patient interface module; a retractable rail adapted to secure a suction cup at an end, the rail moveable between a first position in which the suction cup can be secured to the patient interface and a second position in which a space is provided between the suction cup and the patient interface; and a flatfield OCT module insertable into the space between the suction cup and the PI with the retractable rail in the second position.

9. The docking system of claim 8, further comprising: a guiding mechanism for adjusting an alignment of the patient interface and suction cup relative to the eye.

10. The docking system of claim 9, wherein the alignment is performed based on at least OCT imaging of an anterior segment of the eye when the flatfield OCT module is positioned between the suction cup and the PI.11 . The docking system of any one of claims 8 to 10, further comprising a suction pump connected to the suction cup to provide suction to secure the suction cup to the eye.

12. A method of docking a system to an eye, the method comprising: extending a rail holding a suction cup away from a patient interface towards the eye; position a flatfield OCT module in a space between the suction cup and the patient interface; aligning the patient interface and suction cup to the eye using OCT imaging of an anterior segment of the eye; removing the flatfield OCT module from the space between the suction cup and the patient interface; and retracting the rail and securing the patient interface to the suction cup.

13. A method of generating a firing path for treatment of a floater, the method comprising: receiving 3D OCT scan data comprising a plurality of voxels captured from a vitreous of a patient; performing 3D clustering of the voxels of the received 3D OCT scan data; generating a 3D mesh from the voxels of at least one of the clusters of voxels, the 3D mesh associated with at least a portion of a floater; and generating a laser firing plan using the generated 3D mesh for treating the floater.

14. The method of claim 13, wherein the clustering of the voxels uses k-means clustering.

15. The method of claim 13 or 14, wherein the 3D mesh is generated using a convex hull algorithm.

16. A system for use in generating a firing path for treatment of a floater, the system comprising: a processor for executing instructions; and a memory storing instructions, which when executed by the processor configure the system to perform a method according to any one of claims 13 to 15.

17. A non-transitory computer readable memory storing instructions, which when executed by a processor of a system configure the system to perform a method according to any one of claims 13 to 15.

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