Automatic capsulotomy

Abstract

A system (20) includes a radiation source (48) and a controller (44). The controller is configured to define a treatment zone (88) on a capsular bag (86) of an eye (25) of a subject (22), and to form an opening (96) in the capsular bag by irradiating a plurality of target site regions (94) within the treatment zone in an iterative process after the treatment zone is defined, the iterative process including, during each of a plurality of iterations of the process, acquiring an image (98) of at least a portion of the capsular bag, designating one of the target site regions based on the acquired image, and causing the radiation source to irradiate the designated target site region. Other embodiments are also described.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application 63 / 053,650, filed July 19, 2020, entitled “Automatic posterior capsulotomyand combination device,” the disclosure of which is incorporated herein by reference. Invention Field

[0003] This invention relates to ophthalmic surgery, particularly capsulotomy procedure.

[0004] background

[0005] In some cases, posterior capsule opacification can occur after replacement of the eye's natural lens. In such cases, posterior capsuleotomy may be the preferred treatment.

[0006] U.S. Patent 8,465,478 describes systems, apparatus, and methods for developing laser systems capable of producing precise, predetermined jigsaw capsulotomies. The systems, apparatus, and methods also provide laser systems that can use a single laser as both a therapeutic laser and a lidar, and reduce patient-to-patient and physician-to-physician variability associated with handheld devices used to perform capsulorhexis and capsulotomy. Further description includes precise, predetermined jigsaw shot patterns and shaping capsulotomies based at least in part on the shape of the IOL (and particularly adjustable IOLs).

[0007] U.S. Patent 8,845,625 describes systems and methods for cataract intervention. In one embodiment, the system includes: a laser source configured to generate a therapeutic beam comprising a plurality of laser pulses; an integrated optics system including an imaging component operatively coupled to a therapeutic laser delivery assembly such that they share at least one common optical element, the integrated optics system being configured to acquire image information relating to one or more target tissue structures and to guide the therapeutic beam in a three-dimensional mode to cause breakdown of at least one of the target tissue structures; and a controller operatively coupled to the laser source and the integrated optics system and configured to adjust the laser beam and treatment mode based on the image information, and to distinguish two or more anatomical structures of the eye based at least in part on a robust least-squares fitting analysis of the image information.

[0008] U.S. Patent 10,143,590 describes a method and apparatus for performing laser-assisted posterior capsulotomy and for performing laser ophthalmic surgery on an eye with a penetrating cornea. One method for performing posterior capsulotomy includes injecting fluid between the posterior lens capsule and the anterior vitreous membrane to separate the posterior lens capsule and the anterior vitreous membrane. With the posterior lens capsule separated from the anterior vitreous membrane, posterior capsulotomy is performed on the posterior lens capsule by using a laser to cut the posterior lens capsule.

[0009] U.S. Patent 10,849,789 describes an eye measurement and laser surgery system, comprising: a laser source; a corneal topography subsystem; an axis determination subsystem; a ranging subsystem including an optical coherence tomography (OCT); and a refractive index determination subsystem. All subsystems are under the operational control of a controller. The controller is configured to: operate the corneal topography subsystem to obtain corneal surface information; operate the axis determination subsystem to identify one or more axial lengths of the eye; operate the OCT to sequentially scan the eye through multiple OCT scan modes configured to determine the axial length of the eye; and operate the refractive index determination subsystem to determine the refractive index of one or more eye tissues, wherein at least one of the corneal surface information, axial length information, and axial length is modified based on the determined refractive index. Invention Overview

[0011] According to some embodiments of the present invention, a system is provided, comprising a radiation source and a controller. The controller is configured to define a treatment area on a capsule of a subject's eye, and after defining the treatment area, to form an opening in the capsule by irradiating a plurality of target regions within the treatment area during an iterative process. The iterative process includes, during each iteration of a plurality of iterations of the process, acquiring an image of at least a portion of the capsule based on an acquired image, designating one of the target regions, and irradiating the designated target region with the radiation source.

[0012] In some embodiments, the sac is a posterior sac.

[0013] In some embodiments, the controller is configured to define the treatment area in the following ways:

[0014] Based on at least one initial image of the eye, identify the opening of the anterior capsule in the anterior capsule of the eye, and

[0015] The treatment area is defined so that it is located entirely behind the anterior bursa opening.

[0016] In some embodiments, the controller is configured to define the treatment area in the following ways:

[0017] Based on at least one initial image of the eye, identify the edge of the iris of the eye, and

[0018] Define the treatment area so that the treatment area is completely within the edge.

[0019] In some embodiments, the controller is configured to define the treatment area in the following ways:

[0020] Based on at least one initial image of the eye, identify one or more features of the prosthetic intraocular lens (IOL) in the eye.

[0021] In response to this feature, the estimated location of the IOL is calculated, and

[0022] The treatment area is defined in response to the estimated location.

[0023] In some embodiments, specifying the target region during at least one iteration includes:

[0024] Based on the acquired images, identify the tissue of the capsule at the last specified target region within the target region, and

[0025] In response to identifying the organization, the last designated target region in the target region is reassigned.

[0026] In some embodiments, specifying the target region during at least one iteration includes:

[0027] Based on the acquired images, a portion of the opening's perimeter was identified that was further from the boundary of the treatment area than the rest of the perimeter.

[0028] The target area is specified as being located at a predefined distance from a portion of the identified perimeter.

[0029] In some embodiments, specifying the target region during at least one iteration includes:

[0030] Based on this image, wrinkles within the treatment area are identified, and

[0031] In response to the identification of a wrinkle, a target region is specified such that the target region overlaps with the wrinkle.

[0032] In some embodiments, specifying the target region during at least one iteration includes:

[0033] Based on the acquired images, it was determined that the perimeter of the opening is stable, and

[0034] In response to this determination, the target area is specified.

[0035] In some embodiments,

[0036] The controller is configured to form an opening after a sequence of specified provisional target regions, and

[0037] During at least one iteration, the designated target region includes:

[0038] Based on the acquired images, it is determined that the distance between the next provisional target region and the perimeter of the opening is greater than a predefined threshold distance.

[0039] In response to determining that the distance is greater than a predefined threshold distance, the next provisional target region in the provisional target region is designated as the target region.

[0040] In some embodiments, specifying the target region during at least one other iteration in the iteration includes:

[0041] Based on the acquired image, it is determined that the distance is no greater than a predefined threshold distance, and

[0042] In response to determining that the distance is not greater than a predefined threshold distance, a provisional target region following the next provisional target region in the provisional target region is designated as the target region.

[0043] In some embodiments, specifying the target region during at least one other iteration in the iteration includes:

[0044] Based on the acquired image, it is determined that the distance is no greater than a predefined threshold distance, and

[0045] In response to determining that the distance is not greater than a predefined threshold distance, the target region is specified by applying an offset to the position of the next provisional target region within the provisional target region.

[0046] In some embodiments, the controller is further configured to:

[0047] Define the target boundary on the capsule, and

[0048] The iteration process terminates in response to a predefined threshold percentage at which the opening reaches the target boundary.

[0049] In some embodiments, the controller is configured to define the target boundary by placing the target boundary at a predefined offset inward from the boundary of the treatment area.

[0050] According to some embodiments of the present invention, a method is also provided, comprising defining a treatment area on a capsule of a subject's eye, and after defining the treatment area, forming an opening in the capsule by irradiating a plurality of target regions within the treatment area during an iterative process. The iterative process includes, during each iteration of a plurality of iterations of the process, acquiring an image of at least a portion of the capsule, designating one of the target regions based on the acquired image, and irradiating the designated target region with a radiation source.

[0051] According to some embodiments of the present invention, a computer software product is also provided, comprising a tangible, non-transitory computer-readable medium therein storing program instructions. When read by a controller, these instructions cause the controller to: define a treatment area on a capsule of a subject's eye; and, after defining the treatment area, form an opening in the capsule by irradiating a plurality of target regions within the treatment area during an iterative process. The iterative process includes: acquiring an image of at least a portion of the capsule during each iteration of a plurality of iterations of the process; designating one of the target regions based on the acquired image; and irradiating the designated target region with a radiation source.

[0052] The invention will be more fully understood from the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, in which: Brief description of the attached diagram

[0054] Figure 1 This is a schematic diagram of a system for performing capsulotomy on the capsule of a patient's eye according to some embodiments of the present invention;

[0055] Figure 2 This is a schematic diagram of a cystotomy device according to some embodiments of the present invention;

[0056] Figure 3 This is a schematic diagram of a method for defining a treatment area according to some embodiments of the present invention;

[0057] Figure 4 This is a schematic diagram of an opening formed in a bladder according to some embodiments of the present invention;

[0058] Figures 5-6 This is a schematic diagram of a technique for specifying a target region according to some embodiments of the present invention;

[0059] Figure 7 This is a schematic diagram of a technique for specifying a target region based on a pre-defined sequence of provisional target regions, according to some embodiments of the present invention; and

[0060] Figure 8 This is a flowchart of an example iterative process for forming an opening in the eye sac according to some embodiments of the present invention.

[0061] Detailed description of the embodiments

[0062] Overview

[0063] Traditional cystectomy requires a highly trained specialist physician. Unfortunately, such physicians may be in short supply.

[0064] To address this challenge, embodiments of the present invention provide an automated cystotomy system that allows even physicians with minimal training to perform the procedure. The system includes a radiation source, a camera, a controller, and suitable optics. The controller controls the radiation source and optics based on images acquired by the camera to create an opening in the posterior cyst by irradiating the cyst.

[0065] Typically, the controller first defines a treatment area that includes at least some of the opaque portions of the posterior capsule. Next, the controller designates a first target region (typically at the center of the treatment area) and then irradiates it. After confirming, based on an image of the capsule, that an opening has been initialized at the first target region, the controller designates a second target region at an appropriate distance from the periphery of the opening and then irradiates it. After confirming, based on another image of the capsule, that the opening has been enlarged, the controller designates and then irradiates a third target region. In this way, the controller uses image processing to optimize the designation of the target regions, thereby facilitating more efficient opening enlargement (i.e., using less radiation beam). When it is determined, based on another image, that the opening has been sufficiently enlarged, the controller terminates the procedure.

[0066] Typically, the controller is configured to identify any folds in the posterior bladder via image processing. In response to identifying a fold, a target region overlapping with that fold can be specified. Advantageously, by targeting folds within the bladder, the opening can be expanded more effectively.

[0067] In some embodiments, a sequence of provisional target regions is specified before any irradiation of the capsule. The controller then iterates through the provisional target regions. For each provisional target region, based on its proximity to the opening perimeter, the controller decides whether to irradiate the provisional target region, skip the provisional target region, or irradiate a new target region that deviates from the provisional target region.

[0068] In addition to performing an automated capsulotomy of the posterior capsule as described herein, the controller can create a slit-like opening in the anterior capsule of the eye. Alternatively or additionally, the controller can use any of the techniques described herein to create a larger opening in the anterior capsule.

[0069] System Description

[0070] Original Reference Figure 1 , Figure 1 This is a schematic diagram of a system 20 according to some embodiments of the present invention, the system 20 including a capsulotomy device 21 for performing capsulotomy on the capsule of the eye 25 of a patient 22. Further reference Figure 2 , Figure 2 This is a schematic diagram of a cystotomy device 21 according to some embodiments of the present invention.

[0071] The capsulotomy device 21 includes an optical unit 30 and a controller 44. The optical unit 30 includes one or more beam guiding elements, which include, for example, one or more galvo mirrors 50, which may be collectively referred to as "galvo scanners" and / or beam combiners 56. The optical unit 30 also includes a radiation source 48 configured to irradiate the capsule of the eye 25 with one or more treatment beams 52 by emitting treatment beams toward the beam guiding elements such that the beams are directed by the beam guiding elements to the capsule. Typically, the radiation source 48 is also configured to irradiate the capsule with a pair of aiming beams 53, which are configured to overlap each other only if the distance of the optical unit from the capsule and the positioning of the beam guiding elements provide the desired treatment spot size on the capsule. Therefore, the aiming beams 53 can be used to verify the spot size of each treatment beam before emitting the treatment beams, as referenced below. Figure 8 Further description.

[0072] In some embodiments, the optical unit 30 may further include one or more other optical devices. For example, the optical unit may include a beam expander 70 that expands and then re-collimates the treatment beam 52. In such embodiments, the optical unit 30 typically also includes a focusing module (including, for example, an F-theta lens or another type of lens) configured to focus the treatment beam.

[0073] More specifically, before or simultaneously with the emission of each treatment beam 52 from the radiation source 48, the controller 44 aims the beam guiding element at the target region of the capsule, such that the beam is directed by the beam guiding element to the target region. For example, the beam may be deflected by the scanning galvanometer mirror 50 through the beam expander 70 toward the beam combiner 56, and then by the beam combiner through the focusing module 72, such that the beam impinges on the target region with the desired spot size. (Since each treatment beam impinges on the capsule with a non-infinitely small spot size, each beam is generally described in this application as impinging on a "region" of the capsule rather than on a "point".) The beam thus follows path 92, which extends from the downstream end of the beam guiding element (e.g., focusing module 72) to the target region.

[0074] Typically, the radiation source includes a laser, such as an Nd:YAG laser. (Examples of off-the-shelf products incorporating Nd:YAG lasers include Quantel Medical's Optimis II from Cournon-d'Auvergne, France, and Lumenis' Selecta Duet from Yokneam, Israel.) The laser can be modified to include attenuators, energy meters, and / or mechanical shutters. As an alternative to or addition to the laser, the radiation source can include any other suitable radiation emitter.

[0075] In some embodiments, the treatment beam comprises visible light. Alternatively or additionally, the treatment beam may comprise non-visible electromagnetic radiation, such as microwave radiation, infrared radiation, X-ray radiation, or gamma radiation. Typically, the wavelength of the treatment beam is between 400 nm and 1400 nm (e.g., 532 nm or 1064 nm).

[0076] Typically, the spatial distribution of each treatment beam 52 on the capsule is approximately circular (e.g., with a spot size less than 22 μm). Alternatively, the spatial distribution of each treatment beam 52 can be elliptical, square, or have any other suitable shape. Generally, the size and shape of the treatment beam spot are chosen to provide sufficient energy for the photo-rupture of the capsule.

[0077] Typically, the aiming beam includes visible light (e.g., wavelengths between 600 nm and 700 nm).

[0078] The optical unit 30 also includes a camera 54, which the controller 44 uses to acquire images of the eye. Figure 2 As shown, camera 54 is typically aligned at least approximately with path 92; for example, the angle between path 92 and a hypothetical line extending from eye 25 to the camera may be less than 15 degrees. In some embodiments, the camera is positioned behind beam combiner 56 such that the camera receives light via the beam combiner. In other embodiments, the camera is offset from the beam combiner.

[0079] At the start of the procedure, camera 54 acquires an initial image of the cyst, or an initial image of at least a portion of the cyst. Based on the image, controller 44 defines a treatment area on the cyst, as described below. Figure 3 Further description. Subsequently, during the procedure, camera 54 acquires multiple images of the cyst or at least a portion of the cyst at a relatively high frequency. Controller 44 processes these images and, in response, designates the target area within the treatment zone to be irradiated, as further described below with reference to the accompanying drawings.

[0080] Typically, camera 54 may include one or more imaging sensors of any suitable type, such as charge-coupled device (CCD) sensors, complementary metal-oxide-semiconductor (CMOS) sensors, optical coherence tomography (OCT) sensors, and / or hyperspectral image sensors. Using these sensors, the camera can acquire any suitable type of two-dimensional or three-dimensional image, such as monochrome images, color images (e.g., based on three color frames), multispectral images, hyperspectral images, optical coherence tomography (OCT) images, or images generated by fusing multiple images of different corresponding types.

[0081] Typically, the optical unit 30 also includes a light source 66, which is at least approximately aligned with the path 92. For example, the angle between the path 92 and a hypothetical line extending from the end of the path 92 on the eye 25 to the light source 66 can be less than 20 degrees (e.g., less than 10 degrees). The light source 66 is configured to act as a fixation target 64 by transmitting visible fixation light 68, thereby helping to stabilize the position of the eye. Specifically, prior to surgery, the patient 22 is instructed to fix the eye 25 onto the light source 66. Subsequently, during surgery, the eye 25 is fixed onto the light source by means of the light source 66, which transmits fixation light 68, such that the line of sight of the eye is approximately aligned with the path 92 (since the light source is approximately aligned with the path), and the eye is relatively stable. While the eye is fixed onto the light source, the radiation source irradiates the eye capsule with a therapeutic beam 52.

[0082] In some embodiments, the light source 66 includes a light emitter, such as a light-emitting diode (LED). In other embodiments, the light source includes a reflector configured to reflect light emitted from the light emitter.

[0083] Typically, the wavelength of the stationary light 68 (which can be higher or lower than the wavelength of the therapeutic beam) is between 350 nm and 850 nm. For example, the stationary light 68 can be orange or red, with a wavelength of 600 nm to 750 nm.

[0084] Typically, the optical unit includes an optical stage, and at least some of the aforementioned components belonging to the optical unit (e.g., radiation sources, scanning galvanometer mirrors, and beam combiners) are coupled to the optical stage. Typically, the optical unit also includes a front face 33 through which the treatment beam and the fixation beam pass. For example, the optical unit 30 may include a housing 31 that at least partially surrounds the optical stage and includes the front face 33. (The housing 31 may be made of plastic, metal, and / or any other suitable material.) Alternatively, the front face 33 may be attached to the optical stage or may be an integral part of the optical stage.

[0085] In some embodiments, the front surface 33 is shaped to define an opening 58 through which the treatment beam and the fixation beam 52 pass. In other embodiments, the front surface includes an exit window instead of the opening 58, through which the fixation beam 68 and the treatment beam 52 pass. The exit window may be made of plastic, glass, or any other suitable material that is generally transparent to the treatment beam, the aiming beam, the fixation beam 68, and any light used for imaging the eye (such as the light from the illumination source 60 described below).

[0086] Optical unit 30 is mounted on XYZ stage unit 32, which is controlled by a control mechanism 36 such as a joystick. Using the control mechanism 36, the user of system 20 can position the optical unit before eye treatment (e.g., by adjusting the distance between the optical unit and the eye). In some embodiments, XYZ stage unit 32 includes a locking element configured to inhibit movement of the stage unit after it has been positioned.

[0087] In some embodiments, the XYZ stage unit 32 includes one or more motors 34, and a control mechanism 36 is connected to an interface circuit 46. When a user manipulates the control mechanism, the interface circuit 46 converts the activity into appropriate electronic signals and outputs these signals to the controller 44. In response to these signals, the controller controls the motors 34.

[0088] In other embodiments, the XYZ stage unit 32 is manually controlled via a manipulation control mechanism. In such embodiments, the XYZ stage unit may include a set of gears instead of a motor 34.

[0089] System 20 also includes a headrest 24 comprising a forehead rest 26 and a chin rest 28. During the cystotomy, the patient 22 rests his forehead on the forehead rest 26 and his chin on the chin rest 28. In some embodiments, the headrest 24 also includes a restraint strap 27 configured to secure the patient's head from behind and thus keep the patient's head pressed against the headrest.

[0090] In some embodiments, system 20 also includes a contact lens configured to focus a therapeutic beam and / or stabilize the eye 25 upon contact with the eye.

[0091] In some embodiments, such as Figure 1 As shown, both the headrest 24 and the XYZ table unit 32 are mounted on the surface 38 (e.g., the top surface of a tray or table). In other embodiments, the XYZ table unit is mounted on the surface 38, while the headrest is attached to the XYZ table unit.

[0092] System 20 also includes a monitor 42 configured to display an image of the eye captured by a camera. Monitor 42 may be attached to optical unit 30 or positioned at any other suitable location (e.g., on surface 38 immediately adjacent to device 21). In some embodiments, monitor 42 includes a touchscreen, allowing a user to input commands and / or information to the system via the touchscreen. Alternatively or additionally, system 20 may include any other suitable input device (e.g., a keyboard or mouse) that can be used by a user.

[0093] In some embodiments, the monitor 42 is directly connected to the controller 44 via a wired or wireless communication interface. In other embodiments, the monitor 42 is connected to the controller 44 via an external processor (e.g., a processor belonging to a standard desktop computer).

[0094] In some embodiments, such as Figure 2 As shown, controller 44 is located within XYZ stage unit 32. In other embodiments, controller 44 is located externally to XYZ stage unit. Alternatively or additionally, the controller may cooperate with another external processor to perform at least some of the functions described herein.

[0095] In some embodiments, system 20 is also configured to perform a trabeculoplasty procedure, for example, as described in International Patent Application Publication WO / 2020 / 008323, the disclosure of which is incorporated herein by reference. Thus, using system 20, a trabeculoplasty procedure can be performed on patient 22 before or after a cystotomy procedure; for example, both procedures can be performed during a single placement of patient 22.

[0096] In such embodiments, the treatment wavelength (e.g., 532 nm) for trabeculoplasty may be the same as the treatment wavelength for trabeculoplasty. Alternatively, the radiation source 48 may include a wavelength converter configured to switch the wavelength of the treatment beam from a first wavelength (e.g., 1064 nm) for trabeculoplasty (e.g., 532 nm) to a second wavelength (e.g., 532 nm) for trabeculoplasty, or vice versa. Typically, the radiation source also includes a switch configured to switch the treatment beam between a first optical path including the wavelength converter and a second optical path not including the wavelength converter.

[0097] Alternatively or additionally, in such embodiments, the optical unit 30 may also include one or more illumination sources 60, which include, for example, one or more LEDs, such as white light or infrared LEDs. For example, the optical unit may include an LED ring surrounding the opening 58. In such embodiments, the controller 44 may cause the illumination source 60 to flash intermittently at the eye during trabeculoplasty, as described in International Patent Application Publication WO / 2020 / 008323, the disclosure of which is incorporated herein by reference. This flash can facilitate imaging performed by a camera, and the brightness of the flash can further help constrict the pupil of the eye. (For ease of illustration, in...) Figure 2 The electrical connection between the controller 44 and the lighting source 60 is not explicitly shown. In some embodiments, the lighting source 60 is coupled to the front side 33, such as... Figure 2 As shown.

[0098] like Figure 1 As shown, in some embodiments (especially those performing trabeculoplasty, which typically requires visibility of the entire limbus), the optical unit is tilted upward toward the eye, while the eye gazes downward toward the optical unit, such that path 92 is tilted. For example, the path may be oriented at an angle θ relative to the horizontal line between five and twenty degrees. Advantageously, this orientation reduces obstruction of the patient's eye by the patient's upper eyelid and associated anatomical structures.

[0099] In some embodiments, such as Figure 1 As shown, the tilt orientation of path 92 is achieved by mounting the optical unit on a wedge 40 (which is mounted on the XYZ stage unit). In other words, the optical unit is mounted on the XYZ stage unit via the wedge 40. Figure 2 (The wedge-shaped part 40 is omitted.)

[0100] In some embodiments, as described herein, at least some functions of controller 44 are implemented in hardware (e.g., using one or more fixed-function or general-purpose integrated circuits, application-specific integrated circuits (ASICs), and / or field-programmable gate arrays (FPGAs)). Alternatively or additionally, controller 44 may perform at least some of the functions described herein by executing software and / or firmware code. For example, controller 44 may be embodied as a programming processor including, for example, a central processing unit (CPU) and / or a graphics processing unit (GPU). Program code and / or data, including software programs, may be loaded for execution and processing by the CPU and / or GPU. For example, program code and / or data may be downloaded to the controller electronically via a network. Alternatively or additionally, program code and / or data may be provided and / or stored on a non-transitory tangible medium (e.g., magnetic, optical, or electronic memory). Such program code and / or data, when provided to the controller, create a machine or dedicated computer configured to perform the tasks described herein.

[0101] In some embodiments, the controller includes a modular system (SOM), such as the DART-MX8M from Variscite of Lod, Israel.

[0102] Limited treatment area

[0103] Now for reference Figure 3 , Figure 3 This is a schematic diagram of a method for defining a treatment area according to some embodiments of the present invention.

[0104] Figure 3 The image shows the eye at 25 degrees at the start of the capsulotomy. Specifically, Figure 3 The anterior capsule 76 of the eye is shown, located within the edge 78 of the iris 74. An opening 84 has been formed in the anterior capsule 76 to allow removal of the eye's natural lens (e.g., via phacoemulsification) and insertion of a prosthetic intraocular lens (IOL) 80. Behind the IOL 80 lies the opaque posterior capsule 86 of the eye, on which capsulotomy will be performed.

[0105] Typically, the IOL 80 includes an elliptical optical element 89 connected to a curved filament or "haptics" that holds the IOL in place. For example, the optical element 89 can be circular, having a diameter between 6 mm and 14 mm. Although the IOL 80 is usually transparent, in some cases, such as... Figure 3As shown, one or more features of the IOL 80 (specifically, the optics 89 of the IOL) are visible from behind the opening 84. For example, in some cases, the optics 89 includes a Fresnel lens comprising multiple lens regions, and concentric circles 82 dividing the lens regions are visible.

[0106] At the start of the cystectomy, controller 44 ( Figure 2 A treatment area 88 is defined on the posterior capsule 86 (divided by boundary 90 in this figure). Typically, the treatment area 88 is elliptical (e.g., circular).

[0107] For example, based on camera 54 ( Figure 2 The controller acquires at least one initial image of the eye, and can identify the opening 84 in the anterior capsule 76, for example, by applying any suitable pattern matching and / or edge detection technique to the initial image. The controller can then define a treatment area such that the treatment area is completely behind the opening. For example, the controller can offset the boundary 90 inward from the perimeter of the opening 84 by a predefined distance (e.g., 0.1 mm–1 mm). As an additional safety precaution, the controller can also identify the edge 78 of the iris 74 based on the initial image and verify that the treatment area is completely within the edge 78.

[0108] Alternatively, based on the initial image of the eye, the controller can identify one or more features of the IOL 80, for example, by applying any suitable pattern matching and / or edge detection techniques to the initial image. In response to this feature, the controller can calculate an estimated location of the IOL and then define a treatment area based on the estimated location. Specifically, the controller can define the location and size of the treatment area such that the IOL will not fall out of the opening even if the entire treatment area is opened. As an additional safety precaution, the controller can also verify that the treatment area is completely within edge 78 and / or that the treatment area is completely behind opening 84.

[0109] For example, prior to the procedure, the user can input relevant characteristics of the IOL (e.g., the size and / or number of lens areas belonging to the optics 89) into the controller. Subsequently, based on the input and in response to identifying one or more circles 82, the controller can calculate the position of the center of the optics. In response, the controller can center the treatment area at the center of the optics and / or offset the boundary 90 inward from the perimeter of the optics by a predefined distance (e.g., 0.5mm-1mm) (e.g., according to guidelines specified in relevant medical literature).

[0110] Alternatively, the controller can define the treatment area by offsetting the boundary 90 inward from the edge 78 by a predefined distance (e.g., up to 1 mm) without having to identify any features of the opening 84 or IOL 80.

[0111] Typically, after defining the treatment area, the controller overlays the boundary 90 of the treatment area onto the initial image of the eye, and displays it on monitor 42. Figure 1 The image with the coverage boundary is displayed on the screen. The user can then adjust the treatment area before approving it, for example, by dragging one or more points on the boundary 90 with the mouse.

[0112] In other embodiments, the controller defines the treatment area in response to user input without having to perform any of the image processing described above. For example, the user can input the desired center and radius of the treatment area, and / or drag a point on boundary 90 as described above.

[0113] Form an opening

[0114] After defining the treatment area 88, the controller forms an opening in the sac 86 by irradiating multiple target regions 94 within the treatment area during the iterative process. During each iteration of the process, the controller acquires an image of at least a portion of the sac, designates one of the target regions 94 based on the acquired image, and causes the radiation source 48 ( Figure 2 Irradiate the designated target area. For example, Figure 3 An initial target region is shown at the center of treatment area 88, which the controller can specify and then irradiate during the first iteration of the process.

[0115] For further details, please refer to [link / reference]. Figure 4 , Figure 4 This is a schematic diagram of an opening 96 formed in a capsule 86 according to some embodiments of the present invention.

[0116] Figure 4 Part A shows the effect of irradiation Figure 3 The image 98 shows the eye after the opening 96 is initialized within the first designated target region 94. Based on this image, the controller designates a second target region 94, for example, as referenced below. Figure 5 Further description.

[0117] Figure 4 Part B shows another image 98 after illumination of the second target region, which expands the opening 96. Based on the image, the controller designates a third target region 94.

[0118] Figure 4 Section C shows another image 98 after several additional iterations of irradiating the target area 94. Based on such an image, the controller can decide not to specify any additional target areas, thereby terminating the iteration process.

[0119] For example, the controller can define a target boundary 91 with respect to the opening, for instance, by placing the target boundary 91 at a predefined offset (e.g., 0.01 mm–1 mm) inward from the boundary 90 of the treatment area. The controller can then terminate the process in response to determining a predefined threshold percentage (e.g., 90%–100%) that the opening reaches the target boundary 91. (In such an embodiment, the target boundary 91 can be overlaid on an initial image of the eye before the first treatment beam, and the user can then adjust the target boundary as referenced above.) Figure 3 As described for boundary 90. Alternatively (e.g., if the pupil of the eye is relatively small), the controller may terminate the process in response to determining a predefined threshold percentage (e.g., 90%-100%) that the opening reaches the boundary 90 of the treatment area.

[0120] Now for reference Figure 5 , Figure 5 This is a schematic diagram of a technique for designating a target region 94 according to some embodiments of the present invention.

[0121] Figure 5 It shows that it is usually in Figure 4 The scenario shown in section AB depicts an opening 96 being formed. In such scenarios, in some cases, the controller specifies the next target area by performing the following techniques.

[0122] First, based on image 98, the controller identifies a portion of the opening perimeter that is further away from the boundary 90 than the rest of the perimeter.

[0123] For example, for multiple points 104a along the perimeter, the controller can calculate the shortest distance d0a between point 104a and boundary 90 (i.e., the length of the shortest line between point 104a and boundary 90). The controller can then identify the point 104a with a maximum value of d0a.

[0124] Alternatively, for multiple angles, the controller can calculate the distance d0b between (i) point 104b and (ii) the point where line 102 intersects the boundary 90 at that point 104b, at which line 102 radiating from the center 100 of the treatment area at that angle intersects the perimeter of the opening 96. The controller can then identify the point 104b with a maximum value of d0b.

[0125] Next, the controller designates the target region 94 at a predefined distance d1 from the portion of the identified perimeter. For example, after identifying point 104a as described above, the controller can designate the target region 94a, located on the shortest line between the identified point and the boundary 90, at a distance d1 from the identified point 104a. Similarly, after identifying point 104b as described above, the controller can designate the target region 94b, located on the line 102 connecting the identified point and the boundary 90, at a distance d1 from the identified point 104b.

[0126] Now for reference Figure 6 , Figure 6 This is a schematic diagram of another technique for designating target region 94 according to some embodiments of the present invention.

[0127] In some cases, at least one fold 106 in the tissue of the capsule is located within the treatment area. In such cases, the controller can identify the fold 106, for example, by applying an edge detection algorithm, a line detection algorithm, or any other suitable image processing algorithm to image 98. Subsequently, in response to the identification of the fold, the controller can specify a target region 94 such that the target region overlaps with the fold.

[0128] For example, for each identified fold, the controller can calculate two distances: (i) the distance d2 between the fold center and the nearest point on the opening perimeter, and (ii) the distance d3 between the fold center and the nearest point on the boundary 90. The controller can then identify a set of “targetable” folds where d2 is within a predefined distance range (e.g., 0.2mm-2mm, such as 0.5mm-1mm). Subsequently, the controller can select the targetable fold with a maximum value of d3 and then place the target region 94 at the center of the selected fold. Alternatively, if there are no targetable folds, the controller can alternatively use Figure 5 The technology is used to specify the target area.

[0129] Now for reference Figure 7 , Figure 7 This is a schematic diagram of a technique for specifying a target region based on a pre-specified sequence of provisional target regions according to some embodiments of the present invention.

[0130] In some embodiments, a sequence of provisional target regions 130 is specified before irradiating the capsule (and after defining the treatment area). For example, the controller may display an image of the capsule to the user, who can then manually specify the sequence by clicking the mouse on each portion of the image where the provisional target region 130 is expected to be. Alternatively, the controller may specify the sequence and display it to the user, who can then approve the sequence after moving, adding, or deleting any number of provisional target regions 130.

[0131] Typically, sequences often follow a geometric pattern. For example, provisional target regions may be arranged in a spiral 132 extending outward from the center of the treatment area, or in multiple intersecting lines defining an asterisk. Parts of the sequence may deviate slightly from the pattern, for example, to allow one or more provisional target regions 130 to overlap with folds 106. Figure 6 ).

[0132] In such an embodiment, when opening 96 is formed, the controller iterates through the sequence of provisional target regions 130. For each of the provisional target regions, the controller either (i) designates the provisional target region as the next target region 94, i.e., approves the provisional target region for irradiation, as in Figure 7 As shown in the upper right illustration, (ii) the next target region is specified by applying an offset (typically away from the perimeter of opening 96) to the position of the provisional target region, as in Figure 7 As shown in the right-center illustration, or (iii) designating the next provisional target area as the next target area, as in Figure 7 As shown in the lower right illustration.

[0133] Specifically, for each provisional target area, the controller determines whether the distance d2 between the provisional target area and the perimeter of the opening 96 is greater than a predefined threshold distance (e.g., 0.2mm-0.9mm). If d2 is greater than the predefined threshold distance, the provisional target area is designated as target area 94. Otherwise, the controller either applies an offset or designates the next provisional target area.

[0134] Despite Figures 4-7 The example shown illustrates this, but it should be noted that opening 96 does not necessarily need to be initialized at the center of the treatment area. For example, when scanning the sac in a cross or asterisk pattern, the first target region in each line of the cross or asterisk can be specified as being near the edge of the treatment area.

[0135] Example Iteration Process

[0136] Now for reference Figure 8 , Figure 8 This is a flowchart of an example iterative process 108 for forming an opening in the capsule of the eye according to some embodiments of the present invention. Iterative process 108 can be controlled by a controller within a defined treatment area (e.g., as referenced above). Figure 3 Execute after (as described above).

[0137] Each iteration of process 108 begins with imaging step 110, in which the controller uses camera 54 ( Figure 2The image of at least a portion of the cyst is acquired. Following imaging step 110, in location recognition step 112, the controller identifies the boundary 90 of the treatment area by repeating any of the previous image processing steps used to define the treatment area. Figure 3 The position of the treatment area boundary within the camera's field of view (FOV). (Throughout the procedure, the position of the treatment area boundary within the FOV may change due to eye movement.) For example, if the treatment area is defined by placing boundary 90 at a predefined distance from the perimeter of opening 84... Figure 3 The controller can then identify the perimeter of opening 84 in the most recently acquired image, and then identify the location of the treatment area boundary at a predefined distance from the perimeter of opening 84. For a target boundary 91 that is defined... Figure 4 In one embodiment, the controller can also identify the position of boundary 91 within the camera's field of view (FOV).

[0138] Subsequently, in inspection step 114, the controller checks whether at least one target area has been irradiated (i.e., whether at least one iteration has been performed). If not, the controller performs the target designation step 124 as described below. Otherwise, the controller checks in another inspection step 116 whether the last designated (and irradiated) target area has been opened. In other words, based on the acquired images, the controller checks whether the tissue of the capsule is present in the last designated target area.

[0139] Typically, step 116 comprises two sub-steps. In the first sub-step, the controller identifies the location of the final target region based on the position of boundary 90. For example, based on the position of boundary 90, the controller can calculate any shift of the treatment area center location and then apply the same shift to the location of the final target region. Thus, for example, assuming (i) the final target region is centered at (x0, y0), where the center of the treatment area is at (0, 0), and (ii) the center of the treatment area is now at (dx, dy), the controller can identify (x0 + dx, y0 + dy) as the new location of the final target region. Subsequently, in the second sub-step, the controller calculates the change in pixel values ​​between the final target region in the current image and the final target region in the previous image and compares this change with a predefined threshold.

[0140] If the final target area is not opened (i.e., if the controller identifies cystic tissue at the final target area), the controller redesignates the final target area in target redesignation step 126. In some embodiments, the controller may also increase the energy subsequently used to irradiate the target area in predefined increments. (In such embodiments, typically, the energy may be increased multiple times in predefined increments until a predefined maximum energy is reached, after which process 108 terminates if the target area is still not opened.)

[0141] Alternatively, if the final target area is opened, the controller identifies the opening 96 in the perimeter identification step 118, for example, using any suitable edge detection algorithm. Figure 4 The perimeter of the target. Subsequently, in the dimensional inspection step 120, the controller checks whether the opening is large enough (e.g., by checking whether the opening reaches the target boundary 91, as referenced above). Figure 4 If so, process 108 ends. Otherwise, the controller proceeds to stability check step 122.

[0142] In stability check step 122, the controller checks the stability of the opening's perimeter by comparing its current position and shape relative to the treatment area boundary with its final position and shape. In response to determining that the perimeter is stable, the controller proceeds to target designation step 124. Alternatively, in response to determining that the perimeter is unstable—i.e., the opening is still expanding due to previous irradiation—the controller does not designate a new target area and returns to imaging step 110.

[0143] In target designation step 124, the controller designates a new target area. For example, the controller may first examine any targetable folds, as referenced above. Figure 6 As described above. If a targetable wrinkle is found, the controller can use that wrinkle as a target location, as referenced above. Figure 6 Furthermore, as described above. Alternatively, the controller can specify the target area, as referenced above. Figure 5 or Figure 7 As stated above.

[0144] After executing target designation step 124 or target redesignation step 126, the controller aims at beam 53 in aiming step 128. Figure 2 The controller aims at the designated target area. Subsequently, in imaging step 110, the controller acquires another image of the capsule. The controller then checks in inspection step 134 whether the aiming beams overlap at the designated target area. If not, the controller, in distance adjustment step 136, for example by transmitting an appropriate control signal to motor 34... Figure 2The controller adjusts the distance between the optical unit 30 and the eye. Alternatively or additionally, the controller can adjust at least one optical element in the optical unit (e.g., scanning galvanometer mirror 50 or focusing module 72). Figure 2 The controller then acquires another image of the sac and repeats step 134. In this way, the distance of the optical unit from the eye and / or the position of the optics can be iteratively adjusted by the controller. Alternatively, the distance of the optical unit from the eye can be manually adjusted by the user.

[0145] When the controller (or user) determines that the aiming beams overlap, in irradiation step 138, the controller causes the radiation source 48 ( Figure 2 The designated target area is then irradiated. The controller then begins another iteration of process 108.

[0146] In some embodiments, the aiming beams are shaped into different corresponding portions that define a predefined synthesis pattern, such that the predefined synthesis pattern is formed on the capsule only when the aiming beams overlap each other. For example, an example of such a pattern is described in International Patent Application Publication WO / 2020 / 008323, the disclosure of which is incorporated herein by reference.

[0147] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereto that would occur to those skilled in the art upon reading the above description and that are not found in the prior art.

Claims

1. A system comprising: Radiation source; as well as The controller is configured to: The treatment area was defined on the posterior capsule of the subject's eye, and After defining the treatment area, an opening is formed in the posterior capsule by irradiating multiple target regions within the treatment area during an iterative process, the iterative process including each iteration of the multiple iterations of the process: Acquire an image of at least a portion of the posterior capsule. Based on the acquired image, one of the target regions is specified, and The radiation source is used to irradiate the designated target area.

2. The system according to claim 1, wherein, The controller is configured to define the treatment area in the following manner: Based on at least one initial image of the eye, identify the anterior capsule opening in the anterior capsule of the eye, and The treatment area is defined such that it is located entirely behind the anterior bursa opening.

3. The system according to claim 1, wherein, The controller is configured to define the treatment area in the following manner: Based on at least one initial image of the eye, identify the edge of the iris of the eye, and The treatment area is defined such that it is completely located within the edge.

4. The system according to claim 1, wherein, The controller is configured to define the treatment area in the following manner: Based on at least one initial image of the eye, identify one or more features of the prosthetic intraocular lens (IOL) in the eye. In response to the aforementioned feature, the estimated position of the IOL is calculated, and The treatment area is defined in response to the estimated location.

5. The system according to claim 1, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired images, tissue of the posterior capsule at the last specified target region within the target region is identified, and In response to identifying the tissue, the last designated target region in the target region is reassigned.

6. The system according to claim 1, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired images, a portion of the perimeter of the opening is identified that is further away from the boundary of the treatment area than the rest of the perimeter. The target area is designated at a predefined distance from a portion of the identified perimeter.

7. The system according to claim 1, wherein, Specifying the target region during at least one of the iterations includes: Based on the image, wrinkles within the treatment area are identified, and In response to identifying the wrinkle, the target region is designated such that the target region overlaps with the wrinkle.

8. The system according to claim 1, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired images, it was determined that the perimeter of the opening is stable, and In response to the determination, the target region is specified.

9. The system according to any one of claims 1-8, in, The controller is configured to form the opening after a sequence of designated provisional target regions, and During at least one of the iterations, specifying the target region includes: Based on the acquired image, it is determined that the distance between the next provisional target region in the provisional target region and the perimeter of the opening is greater than a predefined threshold distance. In response to determining that the distance is greater than the predefined threshold distance, the next provisional target region in the provisional target region is designated as the target region.

10. The system according to claim 9, wherein, Specifying the target region during at least one other iteration of the iteration includes: Based on the acquired image, it is determined that the distance is not greater than the predefined threshold distance, and In response to determining that the distance is not greater than the predefined threshold distance, a provisional target region following the next provisional target region in the provisional target region is designated as the target region.

11. The system according to claim 9, wherein, Specifying the target region during at least one other iteration of the iteration includes: Based on the acquired image, it is determined that the distance is not greater than the predefined threshold distance, and In response to determining that the distance is not greater than the predefined threshold distance, the target region is specified by applying an offset to the position of the next provisional target region within the provisional target region.

12. The system according to any one of claims 1-8, wherein, The controller is also configured to: The target boundary is defined on the posterior capsule, and The iteration process is terminated in response to determining a predefined threshold percentage by which the opening reaches the target boundary.

13. The system according to claim 12, wherein, The controller is configured to define the target boundary by placing the target boundary at a predefined offset inward from the boundary of the treatment area.

14. A non-transitory computer-readable medium storing program instructions, said instructions causing the controller to perform a method when read by the controller, the method comprising: Define the treatment area on the posterior capsule of the subject's eye; as well as After defining the treatment area, an opening is formed in the posterior capsule by irradiating multiple target regions within the treatment area during an iterative process, the iterative process including each iteration of the multiple iterations of the process: Acquire an image of at least a portion of the posterior capsule. Based on the acquired image, one of the target regions is specified, and To irradiate the designated target area with radiation.

15. The medium according to claim 14, wherein, The treatment area is defined as including: Based on at least one initial image of the eye, identify the anterior capsule opening in the anterior capsule of the eye; and The treatment area is defined such that it is located entirely behind the anterior bursa opening.

16. The medium according to claim 14, wherein, The treatment area is defined as including: Based on at least one initial image of the eye, identify the edge of the iris of the eye; and The treatment area is defined such that it is completely located within the edge.

17. The medium according to claim 14, wherein, The treatment area is defined as including: Based on at least one initial image of the eye, identify one or more features of the prosthetic intraocular lens (IOL) in the eye; In response to the feature, the estimated position of the IOL is calculated; and The treatment area is defined in response to the estimated location.

18. The medium according to claim 14, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired images, tissue of the posterior capsule at the last specified target region within the target region is identified, and In response to identifying the tissue, the last designated target region in the target region is reassigned.

19. The medium according to claim 14, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired images, a portion of the perimeter of the opening is identified that is further away from the boundary of the treatment area than the rest of the perimeter. The target area is designated at a predefined distance from a portion of the identified perimeter.

20. The medium according to claim 14, wherein, Specifying the target region during at least one of the iterations includes: Based on the image, wrinkles within the treatment area are identified, and In response to identifying the wrinkle, the target region is designated such that the target region overlaps with the wrinkle.

21. The medium according to claim 14, wherein, Specifying the target region during at least one of the iterations includes: Based on the acquired image, it is determined that the perimeter of the opening is stable, and In response to the determination, the target region is specified.

22. The medium according to any one of claims 14-21, in, Forming the opening includes forming the opening after a sequence in a designated provisional target region, and During at least one of the iterations, specifying the target region includes: Based on the acquired image, it is determined that the distance between the next provisional target region in the provisional target region and the perimeter of the opening is greater than a predefined threshold distance. In response to determining that the distance is greater than the predefined threshold distance, the next provisional target region in the provisional target region is designated as the target region.

23. The medium according to claim 22, wherein, Specifying the target region during at least one other iteration of the iteration includes: Based on the acquired image, it is determined that the distance is not greater than the predefined threshold distance, and In response to determining that the distance is not greater than the predefined threshold distance, a provisional target region following the next provisional target region in the provisional target region is designated as the target region.

24. The medium according to claim 22, wherein, Specifying the target region during at least one other iteration of the iteration includes: Based on the acquired image, it is determined that the distance is not greater than the predefined threshold distance, and In response to determining that the distance is not greater than the predefined threshold distance, the target region is specified by applying an offset to the position of the next provisional target region within the provisional target region.

25. The medium according to any one of claims 14-21, further comprising: The target boundary is defined on the posterior capsule; as well as The iteration process is terminated in response to determining a predefined threshold percentage by which the opening reaches the target boundary.

26. The medium according to claim 25, wherein, Defining the target boundary includes defining the target boundary by placing the target boundary at a predefined offset inward from the boundary of the treatment area.

Images