Capsulotomy tool and method

Abstract

A capsulotomy tool having an end effector / two-part oscillating perforating element for creating a controlled automated or assisted precision shaped opening in the anterior capsule. The capsulotomy tool has a shaft with a proximal end and a distal end with an end effector adjacent the distal end of the shaft. In use within an eye, the end effector is adapted and configured for controlled cutting of a surface an anterior capsule of the eye. There is also an actuator coupled to the proximal end of the shaft. The actuator is specifically adapted to drive the shaft so as to produce a controlled longitudinal motion of the perforating end effector. The controlled motion is adapted and configured for directing the controlled cutting via robotic surgical system to create an opening in an anterior capsule of the eye along a cutting path, based on image-guidance data received from an imaging system.

Description

CAPSULOTOMY TOOL AND METHODPRIORITY CLAIM

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 641,359, entitled “CAPSULOTOMY TOOL AND METHOD,” filed on May 1, 2024, the contents of which are incorporated herein by reference in their entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] Some applications of the present invention generally relate to medical apparatus and methods. Specifically, some applications of the present invention relate to apparatus and methods for performing intraocular surgery manually with image guidance or with robotic assistance.BACKGROUND

[0004] During cataract surgery, an anterior capsulorhexis (or “capsulotomy”) is a circular opening in the capsular bag which allows access to the lens material. The capsulotomy is necessary in order for subsequent surgical steps to be performed, such as lens extraction and insertion of the intraocular lens implant.

[0005] The current standard of care is to perform the capsulorhexis manually by tearing the capsule, but it is commonly considered to be one of the most challenging parts of performing a cataract surgery. If not properly done, a poor capsulorhexis can lead to serious complications requiring additional effort and time to remedy.

[0006] Several automated systems are already available and can be used to replace the manually performed procedure. One system named “Zepto” is a pulsed-based technology that provides inconsistent capsulotomy results, uses expensive hardware, and presents a further clinical risk of putting excess stress on the zonules if not properly used. There are also Femtosecond laser-assisted capsulotomy (FLACS) based systems but the cost of this system has prevented more widespread acceptance. There are also “Fugo Plasma BladeAblation Capsulotomy” systems that relies on a variety of plasma blade technologies. These and other related procedures were conceived many years ago but have not achieved broad based acceptance primarily because of poor visibility while performing the procedure.

[0007] As such, there remains a need for improved tools and procedures for performing this important initial step of ophthalmic surgery in a way to minimize damage at cutting / insertion sites and to account for the anatomy of a patient’s eye in real-time.SUMMARY OF THE DISCLOSURE

[0008] Described herein are a variety of capsulotomy tools having a cutting or perforating tool end effector on the distal end of a shaft and a motor driver on the shaft adapted to drive the needle-like end effector in a controlled motion adapted and configured for creating an opening in the anterior capsule of an eye. In one implementation, the capsulotomy tool is adapted and configured for use in an image guided robotically controlled surgery system. Any of the described capsulotomy tools may be used in methods of forming an opening in the anterior capsule of an eye.

[0009] For example, there is an image-guided robotic surgical system configured for a capsulotomy procedure, having: a capsulotomy tool having: a sheath having a proximal end and a curved distal end and a lumen extending from the proximal end to the distal end; an end effector having a proximal end and a distal end, the distal end configured as a flexible perforating element, the end effector within the lumen; an actuator coupled to the proximal end of the sheath adapted to oscillate the end effector within the lumen of the sheath to produce a controlled oscillating motion of the end effector flexible perforating element adapted and configured for controlled cutting and forming an opening in an anterior capsule of the eye; an imaging system having: optical coherence tomography (OCT) configured to scan the anterior capsule of the eye, and a digital microscope configured to visualize and record imaging data of the eye; and a robotic surgical device configured to maneuver the capsulotomy tool to perform the capsulotomy procedure along on a cutting path of overlapping perforations derived from imaging data received from the imaging system, in which one or more of operating properties of the capsulotomy tool and the cutting path are adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

[0010] According to certain examples of the system, the oscillation of the end effector is generated by longitudinal motion of the shaft at the proximal end of the end effector, in which the longitudinal motion of the shaft at the proximal end of the end effector is propagated to the distal end of the end effector.

[0011] According to certain examples of the system, the end effector has a shaft having one or a combination of nickel, titanium and tungsten and the end effector distal end is sufficiently flexible to mimic the curvature of the tool sheath distal end.

[0012] According to certain examples of the system, the portion of the distal end of the end effector is within a flexible intermediary layer inside of the sheath lumen configured to adapt to the curvature of the distal end of the tool shaft. Optionally the flexible intermediary layer is a tube comprised of a lubricious material such as polyetheretherketone (PEEK).

[0013] According to certain examples of the system, the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the tool sheath relative to the surface of the eye, (ii) an oscillation frequency of the end effector, and (iii) a stroke length of the distal end of the end effector.

[0014] According to certain examples of the system, the cutting path is a generally circular path comprised of a plurality of uniform or substantially uniform or pre-determined overlapping perforations.

[0015] According to certain examples of the system, an interval between adjacent engagement points of the end effector to form the plurality of overlapping perforations may vary with some spacing provided where adjacent perforations overlap between 10% to 90% of the diameter of an individual perforation formed by the perforating end effector.

[0016] According to certain examples of the system, the cutting path including the overlap of the plurality of overlapping perforations is adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

[0017] According to certain examples of the system, the robotic surgical device includes serial linkages and a remote center of motion (RCM).

[0018] According to certain examples of the system, the digital microscope is one or more of a stereo digital microscope and a telecentric digital microscope.

[0019] According to certain examples of the system, the distal most end portion of the perforating end effector is configured to be retracted towards and extended away from the distal end of the sheath between cutting one or more of the plurality of overlapping perforations of the cutting path.

[0020] In yet other examples, there is a capsulotomy tool, having: a disposable tool portion, having: a sheath having a proximal end, a curved distal end and a lumen extending from the proximal end to the distal end, and a perforating end effector having a shaft with a flexible distal end, in which the end effector is within the sheath lumen and the flexible distal end is adapted and configured for controlled cutting of a surface an anterior capsule of the eye; anda reusable tool holder and actuator portion releasably coupled to the proximal end of the tool sheath and comprising an actuator, the actuator adapted to drive the flexible distal end to produce a controlled oscillating motion of the flexible distal end of the end effector.

[0021] According to certain examples, the tool is adapted and configured for handheld use.

[0022] According to certain examples, the tool is adapted and configured for use in a robotically controlled surgery system.

[0023] According to certain examples, the actuator of the reusable tool holder and actuator portion is adapted to oscillate the end effector within the tool sheath, in which the oscillation of the perforating distal end is generated by longitudinal motion of the end effector shaft.

[0024] According to certain examples, the perforating end effector is comprised of one or more of nickel, titanium and tungsten, wherein the distal end of the perforating end effector is adapted for motion along the angulation of the sheath curved distal end between 60 degrees and 90 degrees.

[0025] According to certain examples, the end effector is within a lumen in flexible intermediary layer inside of the sheath sized to adapt movement of the perforating distal end along the curvature of the sheath, in which the flexible intermediary layer is a tube comprised of poly etheretherketone (PEEK).

[0026] According to certain examples, the disposable tool portion and reusable tool holder and actuator portion are coupled via magnetically coupling between a tool-side magnet and a tool holder-side magnet, further in which the coupling is secured via a compression spring configured to be compressed.

[0027] According to certain examples of the capsulotomy tool, there is a gap between the proximal end and flexible distal end of the shaft of the perforating end effector, in which the perforating end effector is configured to traverse the gap, in which the gap corresponds to a stroke length of the end effector, wherein the stroke length is 400pm-1200pm.

[0028] According to certain examples, the capsulotomy tool further includes an external sheath of the disposable tool portion having and an inner diameter of 0.80-1.30mm; in which an outer diameter of the proximal end of the sheath is 0.75-1.25 mm.

[0029] In certain examples, the capsulotomy tool of the image-guided robotic surgical system configured for a capsulotomy procedure may be any of the capsulotomy tools described above.

[0030] In yet other examples, there is a method of forming an opening in an anterior capsule of an eye, including: gathering imaging data of the eye from an imaging system comprising optical coherence tomography (OCT) configured to scan the anterior capsule of the eye and a digital microscope configured to visualize and record imaging data of the eye; positioning acapsulotomy tool relative to the surface of the anterior capsule of eye via a robotic surgical device, the capsulotomy tool having a shaft and an end effector at least partially housed within the shaft; determining a cutting path having a plurality of cutting sites on the surface of the anterior capsule of the eye, based on the imaging data from the imaging system; advancing, via the robotic surgical device coupled to the end effector, the end effector to an initial position adjacent to a first of the plurality of cutting sites along the cutting path; operating an actuator coupled to the proximal end of the end effector to extend and withdraw the distal end of end effector through the surface of the anterior capsule of the eye to produce a controlled oscillating longitudinal cutting action of the end effector at the first of the plurality of cutting sites along the cutting path; indexing and advancing the capsulotomy tool via the robotic surgical device to a second of the plurality of cutting sites along the cutting path, via the robotic surgical device; extending a distal end of the end effector through the surface of the anterior capsule of the eye at the second of the plurality of cutting sites along the cutting path; withdrawing the distal end of the end effector above the surface of the anterior capsule of the eye adjacent to the second of the plurality of cutting sites along the cutting path; indexing and advancing the capsulotomy tool to a third of the plurality of cutting sites along the cutting path, via the robotic surgical device; and repeating the extending, withdrawing, indexing and advancing steps until the capsulotomy tool has moved through an entirety of the plurality of cutting sites along the cutting path.

[0031] According to certain examples, the method further includes adjusting, via the robotic surgical device, one or more of (i) operating properties of the capsulotomy tool and (ii) the cutting path, based on the imaging data received from the imaging system in real-time as the capsulotomy tool progresses along the cutting path.

[0032] According to certain examples, the method further includes oscillating the end effector within the shaft via the actuator, in which the oscillation of the end effector is generated by longitudinal motion of the shaft at the proximal end of the end effector, in which the longitudinal motion of the shaft at the proximal end of the end effector is propagated to the distal end of the end effector.

[0033] According to certain examples, the method further includes the end effector being one or more of nickel, titanium and tungsten, in which the distal end of the end effector is flexible for bending between 60 degrees and 90 degrees according to the curvature of the sheath distal end.

[0034] According to certain examples, the method further includes moving the end effector relative to an intermediary layer inside of the sheath lumen for centering the distal end portion within the sheath curved distal end.

[0035] According to certain examples of the method, the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the end effector relative to the surface of the eye , (ii) an oscillation frequency of the end effector, and (iii) a stroke rate of the capsulotomy tool.

[0036] According to certain examples of the method, the cutting path is a circular path comprised of a plurality of uniform overlapping circular perforations.

[0037] According to certain examples of the method, an interval between adjacent engagement points of the end effector to form the plurality of uniform overlapping circular perforations may vary with some spacing provided where adjacent apertures overlap between 10% to 90% of the diameter of an individual aperture formed by the end effector.

[0038] According to certain examples of the method, the cutting path including the overlap of the plurality of uniform overlapping circular perforations is adjusted based on the date received from the imaging system in real-time as the capsulotomy procedure progresses.

[0039] According to certain examples of the method, the robotic surgical device includes serial linkages and a remote center of motion (RCM).

[0040] According to certain examples of the method, the digital microscope is one or more of a stereo microscope and a telecentric digital microscope.

[0041] According to certain examples of the method, the end effector is configured to be retracted towards and extended away from the sheath between cutting one or more of the plurality of uniform overlapping circular perforations of the cutting path.

[0042] According to certain examples of the method, the capsulotomy tool may be any of the capsulotomy tools previously described.

[0043] In various aspects, there is provided a capsulotomy tool having a sheath with a proximal end and a curved distal end with a lumen extending from the proximal end to the distal end. A perforating or cutting end effector is positioned within and moveable along the lumen. The distal end of the end effector is adapted and configured for controlled movement beyond the distal end of the tool for use within an eye for controlled cutting or perforating of a surface an anterior capsule of the eye. An actuator is coupled to the proximal end of the sheath and adapted to produce a controlled motion or oscillation of the end effector distal end within the lumen of the sheath. The controlled oscillating motion of the end effector flexible perforating element may be adapted and configured for controlled cutting and forming an opening in an interior capsule of the eye. Embodiments of the capsulotomy tool may be adapted and configured for handheld use or for use in a robotically controlled surgery system. The end effector may be a fine, flexible shaft with behavior similar to the action of a needlebut functioning on a micro scale. In some embodiments, the curved distal end of the sheath may range from 60 to 80 degrees. The distal most portion of the perforating end effector may have a flat, curved, beveled or conical shape. Other shapes are possible and may mimic the general shapes of those used in needles such as, by way of example, a bevel tip, a franseen tip, a diamond tip, and a conical tip. Still further, the perforating end effector may be a single diameter shaft or a combination of a larger diameter shaft adapted for transmission of the linear motion from the actuator coupled to a smaller diameter distal end portion suited to function as a perforation element. The capsulotomy tool sheath may have a circular cross section or an oval cross section with a corresponding shaft shape for the perforating end effector. In still other variations, the capsulotomy tool shaft and perforating end effector are dimensioned for atraumatic access into an interior portion of an eye via a surgical incision that is less than 3 mm wide, less than 2.5 mm wide or less than 2 mm wide.

[0044] In still other aspects, there is provided a method of forming an opening in an anterior capsule of an eye by performing the steps of introducing a capsulotomy tool through a surgical incision in an eye, the capsulotomy tool having a shaft and an end effector on a distal end of the shaft. Next, there is a step of advancing the shaft to place the end effector into an initial position for cutting along a trajectory on an anterior capsule surface of the eye. Next, there is a step of operating an actuator coupled to the shaft to produce a controlled predetermined cutting or perforating action using the end effector. Thereafter, there is a step of manipulating the capsulotomy tool sheath so that the end effector advances along a preplanned trajectory on the anterior capsule surface of the eye. In one embodiment, the preplanned trajectory comprises a series of openings (partial or complete) formed in the anterior capsule, each successive opening may be indexed at a spacing as determined by the cutting plan. Additionally or optionally, an interval between adjacent perforation points created by the end effector distal end may vary with some spacing provided where adjacent perforations (partial or complete) overlap more than 50%, less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, less than 5%, less than 1% of the width of an individual perforation or cutting action formed by the end effector distal end. In still other variations, the step of operating the actuator produces a movement of the end effector at a frequency within a range from 100-1000 Hz. Optionally, the methods performed are directed to forming an opening in the anterior capsule sized from 4 mm to 7 mm. In additional aspects, the methods are directed to forming an opening in the anterior capsule sized and shaped in preparation for a subsequent intraocular lens implantation procedure. In some embodiments, the capsulotomy tool provides a visual-tactile-force feedback signal to a user or to a control system. In another aspect, the end effector completes the cutting along the trajectory in less than 9 seconds, lessthan 8 seconds, less than 7 seconds or less than 6 seconds. Advantageously, the capsulotomy tools and methods may be adapted and combined variously depending upon a number of factors such as surgeon preference, clinical considerations, a relationship between the frequency of motion of the distal end and the amount of overlap as well as specific anatomical considerations on the structure of the eye undergoing treatment.

[0045] All and each of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0046] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:

[0047] FIG. l is a flow diagram describing a closed-loop image-guided robotic system for performing a capsulotomy procedure.

[0048] FIG. 2 is an illustration of a setup for an image-guided capsulotomy procedure.

[0049] FIG. 3A is a side view of an embodiment of the capsulotomy tool.

[0050] FIG. 3B is an exploded view of a distal end of the capsulotomy tool.

[0051] FIG. 3C is a side view of a capsulotomy tool holder and actuation structure.

[0052] FIG. 3D is an assembled view of the capsulotomy tool and capsulotomy tool holder and actuation structure from FIGS. 3A-3C.

[0053] FIG. 4 is an exemplary cutting path for a capsulotomy via a pattern tracing of perforations.

[0054] FIG. 5 depicts exemplary overlapping perforations for a capsulotomy.

[0055] FIG. 6 is an exemplary diagram of the capsulotomy tool positioned on the eye of a patient.

[0056] FIG. 7A-7C depict variations of capsulotomy tool tip angles.

[0057] FIG. 7D is an exemplary cross-section of a distal end of the capsulotomy tool sheath and tube.

[0058] FIG. 8A is a flow chart for a method of preparing a capsulotomy tool for performing a capsulotomy procedure using an image-guided robotic system.

[0059] FIG. 8B is a flow chart for a method of performing a capsulotomy procedure with a capsulotomy tool using an image-guided robotic system.DETAILED DESCRIPTION

[0060] Embodiments of the capsulotomy tool of the present invention improve upon the existing systems by providing a microscale perforation end effector used for controlled puncturing, cutting or perforating the anterior capsule. The end effector may be controlled in such a way that the punctures or individual perforations in the anterior capsule are formed at regular intervals along a desired trajectory to provide the desired shape for the opening in the anterior capsule. In one aspect, the interval between adjacent engagement points of the end effector may vary with some spacing provided where adjacent perforations overlap more than 50%, less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, less than 5%, less than 1% of the width of an individual complete perforation formed by the end effector. As further described with regard to FIGS. 4 and 5, the initial perforation into the surface of the capsule will be the full size of the profile of the end effector distal end. Subsequent to the initial opening, the subsequent perforations or openings formed will vary in shape and size based on the desired degree of overlap. In still another alternative, the adjacent perforations or openings are in contact by an interval that is regular or may also vary according to various factors such as surgeon preference, type of end effector used or anatomical makeup of the anterior surface, such as elasticity or localized topography. In one mode of operation, the arrangement of adjacent apertures follows a circular trajectory. In another mode of operation, the arrangement of adjacent apertures follows an oval trajectory. Trajectories that are hybrid shapes or unique shapes may also be specified by the user and completed by the use of an embodiment of the capsulotomy tool. In other aspects, the end effector distal most end is extended beyond the curved distal end of the tool sheath and then vibrated or oscillated at a controlled frequency and magnitude relative to the anterior surface of the capsular bag. In one embodiment, the curved distal end of the tool sheath is controlled to enable the end effector distal end to maintain an orientation in use that is in a desired relative orientation to the anterior surface of the capsular bag to produce the desired perforation or cutting path results. As a result, orientations in any of a range of various angular positions may be used to change the angle of attack of the end effector distal end to a surface portion of the anterior capsule within the cutting path.

[0061] According to one example, there is an image-guided robotic surgical system configured for a capsulotomy procedure, including: a capsulotomy tool having: an external shaft having a proximal end and a distal end, an end effector (needle) having a straight rigid portion coupled to a flexible curved portion at a distal end, in which the end effector housed at least partially within the shaft, in which a distal end of the end effector is adapted and configured for controlled cutting of a surface an anterior capsule of the eye, and an actuatorcoupled to the proximal end of the end effector, the actuator adapted to drive the end effector so as to produce a controlled motion of the end effector that is adapted and configured for directing the controlled cutting to create an opening in an anterior capsule of the eye; an imaging system having: optical coherence tomography (OCT) configured to scan the anterior capsule of the eye, and a digital microscope configured to visualize and record imaging data of the eye; and a robotic surgical device configured to maneuver the end effector to perform the capsulotomy procedure along on a cutting path derived from imaging data received from the imaging system, in which one or more of operating properties of the capsulotomy tool and the cutting path are adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

[0062] According to one example of the image-guided robotic surgical system, the actuator is adapted to oscillate the end effector within the shaft. The oscillation of the end effector may be generated by longitudinal motion of the shaft at the proximal end of the end effector and the longitudinal motion of the shaft at the proximal end of the end effector may be propagated to the distal end of the end effector.

[0063] According to one example of the image-guided robotic surgical system, the perforating end effector material may include one or more of nickel, titanium and tungsten. The distal most end of the perforating end effector may be sufficiently flexible to repeatably bend along a curvature of between 60 degrees and 90 degrees.

[0064] According to one example of the image-guided robotic surgical system, the end effector may be encapsulated within a flexible intermediary layer inside of the shaft configured to adapt to a degree of the curvature of the distal end of the tool sheath. The lubricious intermediary structure may be a tube comprised of polyetheretherketone (PEEK).

[0065] According to one example of the image-guided robotic surgical system, the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the end effector relative to the surface of the eye , (ii) an oscillation frequency of the end effector, and (iii) a stroke rate of the capsulotomy tool.

[0066] According to one example of the image-guided robotic surgical system, the cutting path may be a circular path comprised of a plurality of uniform overlapping circular perforations.

[0067] According to one example of the image-guided robotic surgical system, an interval between adjacent engagement points of the end effector to form the plurality of uniform overlapping circular perforations may vary with some spacing provided where adjacentapertures overlap between 10% to 90% of the diameter of an individual aperture formed by the end effector.

[0068] According to one example of the image-guided robotic surgical system, the cutting path including the overlap of the plurality of uniform overlapping circular perforations may be adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

[0069] According to one example of the image-guided robotic surgical system, the robotic surgical device may include serial linkages and a remote center of motion (RCM).

[0070] According to one example of the image-guided robotic surgical system, the digital microscope may be one or more of a stereo digital microscope and a telecentric digital microscope.

[0071] According to one example of the image-guided robotic surgical system, the end effector may be configured to be retracted towards and extended away from the sheath between cuttings of one or more of the plurality of uniform overlapping circular perforations of the cutting path.

[0072] In another embodiment, there is a capsulotomy tool, having: an external shaft having a proximal end and a distal end; an end effector (needle) having a straight rigid portion coupled to a flexible curved portion at a distal end, in which the end effector housed at least partially within the shaft. A distal end of the end effector may be adapted and configured for controlled cutting of a surface an anterior capsule of the eye; and also included is an actuator coupled to the proximal end of the end effector, the actuator adapted to drive the end effector so as to produce a controlled motion of the end effector that is adapted and configured for directing the controlled cutting to create an opening in an anterior capsule of the eye.

[0073] According to one example of the capsulotomy tool, the capsulotomy tool may be adapted and configured for handheld use.

[0074] According to one example of the capsulotomy tool, the capsulotomy tool may be adapted and configured for use in a robotically controlled surgery system.

[0075] According to one example of the capsulotomy tool, the actuator may be adapted to oscillate the end effector within the shaft. The oscillation of the end effector may be generated by longitudinal motion of the shaft at the proximal end of the end effector. The longitudinal motion of the shaft at the proximal end of the end effector may be propagated to the distal end of the end effector.

[0076] FIG. l is a flow diagram describing a closed-loop image-guided robotic system for performing a capsulotomy procedure 100. As shown here, imaging system 105 acquires 3D imaging data 104 from a patient’s eye to be operated on. Imaging data may be acquired fromocular coherence tomography (OCT), and a digital microscope (DM) such as a stereo digital microscope or a telecentric digital microscope. An exemplary DM refresh rate of ~60Hz) may be used to generate a capsulotomy cross-section "birds eye view" (in the plane of the eye, parallel to limbal plane). OCT may provide depth information, for example, if the eye is tilted.

[0077] In certain embodiments, and to improve processing efficiency and speed, 3D imaging data 104 may be acquired from only certain portions and / or depths of an operating volume 102 of the patient’s eye, such as around the location of a surgical instrument such as oscillating surgical instrument 103. The OCT of the imaging system may have an acquisition frequency of anywhere between 1Hz and 200,000 Hz, depending on the scan pattern. A single axial scan (“A-scan”) may be a single core sample of the eye, obtaining depth-based optical measurements of a single “pixel” (as viewed from the top of the eye). On the other hand, a full-resolution 3D volumetric scan (comprised of many “A-scans”) may require -IHz. The OCT can be down-sampled in a way such that it actively tracks the tooltip, only sampling in a small region around the tooltip. This may allow for greatly increased OCT sampling frequency. A bottleneck for closed-loop image guidance may be Al / Image processing, which cannot reach the 300 Hz range.

[0078] Based on the 3D imaging data 104, the imaging system 105 defines a capsulotomy cutting path 106. Robotic end-effector 110, which in certain embodiments may be an actuator coupled to a motor, rods, shafts, and a capsulotomy tool holder (see FIG. 3C-3D), follows the defined capsulotomy cutting path 106 and may be coupled to a controlling robotic arm 108 as part of a robotic surgery device or system. Robotic end-effector 110 causes oscillation of an oscillating surgical instrument 103 within an operating volume 102 of the patient’s eye.

[0079] FIG. 2 is an illustration of a setup for an image-guided capsulotomy procedure 200. A capsulotomy path 230 may be defined as a set of points within the reference frame of imaging system 205, defined using 3D image data 104 of the patient’s eye (from FIG. 1). Capsulotomy path 230 may be interpreted by robotic arm 108 of the robotic surgical device / system (from FIG. 1), such that the robotic end effector 110 (from FIG. 1) accurately follows capsulotomy path 230 as defined in the imaging system 205. According to certain embodiments, imaging system 205 acquires data in real-time, updating capsulotomy path 230 as necessary to reflect changes in intraocular anatomy.

[0080] Additional details of and various aspects of integrating an imaging system, robotic surgical device, and tracking and positioning a capsulotomy tool are described in the following applications: International Patent Application No. PCT / US19 / 32236 entitled SYSTEM AND METHOD FOR AUTOMATED IMAGE-GUIDED ROBOTICINTRAOCULAR SURGEY filed May 14, 2019, U.S. Divisional Patent Application No. 18 / 324,984 entitled INTRAOPERATIVE ASSESSMENT OF IMPLANT POSITIONING filed May 23, 2023, and U.S. Provisional Patent Application No. 63 / 514,777 entitled ROBOTIC ASSISTED OPTHALMIC SURGERY SYSTEM filed July 20, 2023, each of which are herein incorporated by reference.

[0081] FIGS. 3 A and 3B illustrate a two-part perforating end effector having a straight shafted sized for movement within the tool sheath lumen and a flexible distal end portion. The flexible end portion is selected to be flexible enough to bend according to the tool sheath curvature and yet have sufficient column strength to perform the cutting or perforation action. Put another way the perforating end effector distal end is selected to be flexible yet not buckle within use. In still other variations or alternatives, the shaft and the end effector of the perforating element may be a single piece that is sized for movement within the tool sheath lumen with a flexible distal end portion to follow along the curved distal end of the sheath.

[0082] FIG. 3A is a side view of an embodiment of the capsulotomy tool. External sheath 304 may be a hollow, curved, and rigid shaft. The capsulotomy tool (oscillating surgical tool / instrument) in one embodiment is a replaceable detachable surgical instrument that interfaces 313 with a tool holder (see FIG. 3B) via mechanical threads and a magnetic interface such as tool-side magnet 310 on distal magnet holder 314. Within the external sheath 304 is a two-part needle-like structure: a straight / rigid shaft portion 301 which may be coupled to or transition into a flexible tool tip / curved / cutting distal end portion 302. In certain embodiments, such as seen in FIG. 3B, the flexible tool tip / curved / cutting portion 302 is a smaller diameter and more flexible shaft. In order to make up the difference between the smaller diameter of the distal portion 302 a centering element or tube may be provided within the tool shaft 304. For example, there is a centrally traversing lumen through a flexible / low friction tube 303 which is sized and positioned to correspond to the distal end 302. The lumen opens distally at the end of the tool sheath 304 via opening 308 (see FIG. 3B).Opening 308 and the distal end 302 are then positioned near or at a cutting site along the cutting path. The tool sheath 304 is stationary and does not oscillate, allow for stability around cutting / insertion sites on the surface of the anterior capsule of the patient’s eye as flexible tool tip perforating portion 302 advances along the cutting path. The straight / rigid shaft portion 301 is fixed to the magnetic interface on the distal magnet holder 314. According to certain embodiments, flexible tool tip / curved portion 302 may be retracted into external sheath 304 when not in use or when indexing and advancing between cutting sites on the surface of the anterior capsule of the patient’s eye during capsulotomy procedures.Flexible tool tip / curved / perforating portion 302 may be comprised of one or more of nickel,titanium, or tungsten material. Also shown is a compression spring 311 coupled to the magnetic interface on distal magnet holder, which may translate linear input motion 310 to actuate flexible tool tip / curved needle portion 302. There is also a sleeve adapter 312 to support or house compression spring 311 and magnetic interface on the distal magnet holder 314. Sleeve adapter 312 may be configured to be coupled to adapter nut 357 on the capsulotomy tool holder (see FIG. 3C).

[0083] FIG. 3B is an exploded view of a distal end of the capsulotomy tool. Shown here is shaft / rigid portion 301 and flexible / low friction tube 303 within external sheath 304 with gap 399 between them. Flexible tool tip / curved portion 302 may be secured to a distal portion of shaft / rigid portion 301, extend through gap 399 and through inlet / chamfer 305 of flexible / low friction tube 303, through flexible / low friction tube 303 and out of flexible / low friction tube 303 through opening 308. Gap 399 may correspond to a maximum stroke length of flexible tool tip / curved portion 302, which may include a safety margin. In certain examples, gap 399 may be configured to be narrow to accommodate stroke length and / or to prevent buckling of shaft / rigid portion 301.

[0084] Flexible / low friction tube 303 may be comprised of any lubricious material, that is sized and shaped for centering the distal end portion of the end effector within the curved distal end of the sheath. On exemplary materials is polyetheretherketone (PEEK). In certain examples, flexible / low friction tube 303 may be glued or affixed to external sheath 304. Inlet / chamfer 305 may produce a buffered or gradual interface for the flexible tool tip / curved portion 302, so as to prevent buckling the straight / rigid shaft portion 301 due to the overall dimensions of the distal end (i.e., diameter on the micron or sub-micron scale). Inlet / chamfer 305 may be configured to align and stabilize the flexible tool tip / curved portion 302 within the flexible / low friction tube 303 and to prevent kinking of the flexible tool tip / curved portion 302. In certain examples, there may be a radial gap of 25 pm between flexible tool tip / curved portion 302 and flexible / low friction tube 303.

[0085] According to certain example, an outer diameter of straight / rigid shaft portion 301 may be between 0.75-1.25 mm and an inner diameter of external sheath 304 may be 0.80- 1.30mm.

[0086] FIG. 3C is a side view of a capsulotomy tool holder and actuation structure. Capsulotomy tool holder interfaces with the oscillating tool and produces the linear oscillating / cutting motion 315 of the tool tip 302 (see FIGS. 3A-3B). The linear oscillating / cutting motion 315 of FIG. 3 A comes from an input motor 350 connected to a wheel 351, which may be an eccentric wheel. The central axes of the motor 350 and wheel 351 are offset, such that a rotation of the motor 350 produces circular motion of the centralaxis of the wheel 351. In certain embodiments, the amount of offset or eccentricity may be slight, and equal to the "stroke length" of the flexible tool tip / curved / cutting needle portion 302. Exemplary stroke lengths may include 400pm, 800pm, and 1200pm. The wheel 351 contains a ball bearing 352, which contains an eccentric shaft 353 configured to receive or hold a follower rod 354. The motion of the eccentric wheel 351 and the configuration of the follower rod 354, eccentric shaft 353, and ball bearing 352 are such that a continuous rotation of the motor 350 produces oscillating / cutting linear motion 315 of the follower rod 354 along the axis of the follower rod 354. In certain examples, an oscillation frequency of oscillating / cutting linear motion 315 of the follower rod 354 may be 100-1,000 Hz. Also shown is sleeve bearings 355 on actuator sleeve 356, which may be coupled to an adapter nut 357 via a tool holder-side magnet 358 and magnet holder 359. Adapter nut 357 may be configured to receive the capsulotomy tool, and specifically the sleeve adapter portion 312 of the capsulotomy tool, of FIG. 3 A.

[0087] In certain examples, the capsulotomy tool holder and actuation structure of FIG. 3C may be a reusable component configured to magnetically couple with the capsulotomy tool of FIG. 3 A which may be a disposable component. In such examples, magnetic coupling may occur between tool-side magnet 310 of FIG. 3 A and tool holder-side magnet 358 of FIG. 3C. This may occur in tandem with sleeve adapter 312 of FIG. 3 A coupling to or screwing into adapter nut 357 of FIG. 3C, which may compress compression spring 311 of FIG. 3 A to secure the capsulotomy tool holder and actuation structure of FIG. 3C to the capsulotomy tool of FIG. 3A while securing the connection of straight / rigid shaft portion 304.

[0088] FIG. 3D is an assembled view of the capsulotomy tool and capsulotomy tool holder and actuation structure from FIGS. 3A-3C. The capsulotomy tool (“needle assembly”) and capsulotomy tool holder (“actuator assembly”) may be magnetically coupled and secured via compression spring 311 as previously described to form one rigid body. In certain examples, the capsulotomy tool is detachable via the magnetic coupling and disposable. Shown here the previously described components of capsulotomy tool and capsulotomy tool holder including wheel 351, ball bearings 352, eccentric shaft 353, follower rod 354, motor 350, actuator sleeve 356, adapter nut 357, magnet 358, sleeve adapter portion 312, external sheath 304, straight / rigid shaft portion 301 and flexible / low friction tube 303. In certain examples, motor 350 may be coupled to a collar (not shown) which may be configured to rotate and translate motion to move ball bearings 352 left or right. Ball bearings 352 may have an offset axis configured to stabilize eccentric shaft 353 and to translate axial oscillation along follower rod 354, and via the magnetic coupling to straight / rigid shaft portion 301. In certain embodiments, the assembled capsulotomy tool and capsulotomy tool holder may be coupledto a robotic surgical device / system as previously described for guidance of flexible tool tip / curved perforating portion 302 (from FIGS. 3A-3B) through the cutting path on the patient’s eye.

[0089] In still other embodiments, the capsulotomy tool actuator assembly illustrated and described with regard to FIGS. 3A-3D may include a number of modifications, alternatives or variations of one or more assemblies or components. In one aspect, the vibration generation source of an actuator may be provided by one or a combination of an electric motor, an electromagnetic actuator such as a voice coil or other implementation, a pneumatic or hydraulic source, or a piezoelectric source. Additionally or optionally, the transmission used for the actuator may include a direct drive, cams, eccentric wheel s / dri vers or swashplate assemblies. Still further, there may be provided capabilities for limiting or constraining the stroke produced at the end effector distal end portion such by the incorporation of one or a combination of motion limiting stops such as hard - hard stops, hard-elastic stops or elasticelastic stops or combinations thereof.

[0090] FIG. 4 is an exemplary cutting path 430 for a capsulotomy via a pattern tracing of perforations. In other words, a target perforation pattern of the capsulotomy tool is described within the image guided robotic control system. The target perforation pattern may be configured for clean and precise cutting to conform to patient eye anatomy, for centering opening(s), to minimize trauma and match or overlap with dimensions of an intraocular lens (IOL) to be implanted into the eye. Motion of the robotic end-effector 110 (from FIG. 1), combined with simultaneous perforation via linear or longitudinal oscillation of oscillating surgical instrument 103 (from FIG. 1) results in a path comprising a repeatable pattern of circular perforations 401 in the anterior capsule of the patient’s eye. In certain embodiments, a cut made at a first cutting site of cutting path may be a complete circle, and cuts made at subsequent cutting sites may be a partial circle or crescent shape or section based on the degree of overlap. Image-guidance from imaging system 105 (from FIG. 1) may be used for assessing cut quality along the capsulotomy cutting path 530, such as a continuity of the overall incision made by the capsulotomy tool and the roughness of the edges of the incision / cuts, as well as the trajectory or the difference between a pre-planned trajectory for cutting path 430 and the actual trajectory of cutting path 430 that is updated in real-time, for example in response to the anatomy of the patient’s eye.

[0091] FIG. 5 depicts exemplary overlapping perforations for a capsulotomy 500. As shown here, there is an overlap 502 between adjacent perforations 501A and 501B. Perforations 501A created by oscillating surgical instrument 103 (from FIG. 1) overlap 502 with neighboring perforations 50 IB by an amount relative to the diameter of the perforation 504.The degree of overlap 502 ranges from 10% to 90% of the perforation diameter 504. The material properties of the anterior capsule of the patient’s eye may require different amounts of overlap 502 (for instance, patients with thicker or stiffer capsule walls might require more significant overlap 502 between neighboring perforations 501A / 501B, for example to produce stronger and cleaner cuts along capsulotomy cutting path 430 (from FIG. 4). In certain embodiments, a measurement of overlap 502 may be 10-90% of a diameter 504 of a perforation 501A or 501B and adjusted along capsulotomy cutting path to maintain a desired trajectory or to accommodate for patient eye anatomy or other parameters such as oscillation of the end effector perforating tip 302 (see FIGS. 3 A-3B). In certain embodiments, in order to achieve or maintain a desired overlap 502, the robotic surgical system may calculate a velocity for the robotic surgical device to move the capsulotomy tool curved end portion based at least in part on an oscillation frequency of the end effector, the degree of overlap and the stroke of the perforation element, the local thickness of the anterior capsule and other factors. According to certain embodiments, the oscillation frequency may be 300 Hz. While desiring not to be bound by theory, it is believed that a too low oscillation frequency may result in incomplete overlap 502, lack of overlap 502 or not account for full distal end effector stroke or movement relative to the capsule.

[0092] In certain embodiments the robotic surgical device determines a speed of indexing and / or advancing the capsulotomy tool and the distal end of its end effector (needle tip 302) based on various parameters including an oscillation frequency of the distal most end of the end effector, a size of the end effector and the degree of overlap desired between perforations made at adjacent cutting sites. In yet other embodiments, the imaging system monitoring the cutting path and the progress and trajectory of the capsulotomy tool through it, and provides imaging data to the robotic surgical device which the robotic surgical device uses to determine the speed of indexing and / or advancing the capsulotomy tool and the distal end of its end effector perforator tip. In these or other embodiments, the robotic surgical system ensures that the capsulotomy tool is correctly following the cutting path including any changes made to the cutting path in real time including the degree of overlap between perforations made at adjacent cutting sites, as well as oscillating the perforating tip at a desired frequency to create the necessary perforations along the cutting path. For a given oscillation frequency, the speed used by the robotic surgical system to move the capsulotomy tool and needle tooltip should be such that the desired overlap 502 is maintained.

[0093] FIG. 6 is an exemplary diagram of the capsulotomy tool positioned on the eye of a patient 600. According to certain embodiments, external sheath 604 is stationary and does not oscillate as linear / longitudinal motion 610 translates from motor 350 of capsulotomy toolholder (FIG. 3C) to tooltip motion 602M of flexible tool tip / curved / cutting needle portion 602. This allows for stability around cutting / insertion site 680 on the surface of the anterior capsule of the patient’s eye 640 as flexible tool tip / curved / cutting needle portion 602 cuts along the cutting path (tooltip motion 602M). According to certain embodiments, robotic surgical device / system including robotic arm 108 from FIG. 1 may rotate and laterally angle the capsulotomy tool and flexible tool tip / curved / cutting needle portion 602 to cut through and withdraw from a plurality of cutting / insertion sites 680 along the cutting trajectory. This may be done in order to produce the desired circular or semi-circular perforations 401 (from FIG. 4) and minimize or avoid tearing of cuts along the cutting path, and / or in response to real-time imaging data received from imaging system 105 (from FIG. 1) regarding the anatomy of a patient’s eye as the capsulotomy tool progresses through the cutting path.

[0094] FIG. 7A-7C depict variations of capsulotomy tool tip angles. As previously discussed, orientations in any of a range of various angular positions may be used to change the angle of attack of the end effector distal end to a surface portion of the anterior capsule within the cutting path.

[0095] FIG. 7A shows a tool tip angle with 60 degrees (702) of bending or curvature.

[0096] FIG. 7B shows a tool tip angle with 74 degrees (704) of bending or curvature.

[0097] FIG. 7A shows a tool tip angle with 81 degrees (706) of bending or curvature.

[0098] FIG. 7D is an exemplary cross-section of a distal end of the capsulotomy tool sheath and tube. Shown here is an outer diameter 704, a middle diameter 703 (corresponding to a tube of lubricious material such as polyetheretherketone (PEEK), such as tube 303 from FIGS. 3A-3B and 3D), and a lumen / inner diameter 799 of the middle diameter 703 configured for the distal end of the capsulotomy tool or needle to traverse and approximately corresponding in diameter to a diameter of the needle. According to certain embodiments, lumen / inner diameter 799 corresponds to a diameter of the needle 302 (from FIGS. 3A-3B). Also according to certain embodiments, outer diameter 704 is from 500pm to 2mm, middle diameter 703 is 100 pm to 1mm, and lumen 799 is 50 pm -100pm. According to certain embodiments, middle diameter 703 may be a low-friction bearing surface for the needle and an inner diameter of a curved hollow metal shaft such as external shaft 304 (from FIGS. 3A- 3B and 3D). Middle diameter 703 may be configured to stabilize and center the needle 302 within external shaft 304.

[0099] FIG. 8A is a flow chart for a method of preparing a capsulotomy tool for performing a capsulotomy procedure using an image-guided robotic system 800.

[0100] Method 800 begins at block 805 with gathering imaging data of the eye from an imaging system comprising optical coherence tomography (OCT) configured to scan theanterior capsule of the eye and a digital microscope configure to visualize and record imaging data of the eye.

[0101] Method 800 continues at block 810 with positioning a capsulotomy tool relative to the surface of the anterior capsule of the eye via a robotic surgical device, the capsulotomy tool having a shaft and an end effector at least partially housed within the shaft.

[0102] Next, at block 815, method 800 includes determining a cutting path having a plurality of cutting sites on the surface of the anterior capsule of the eye, based on the imaging data from the imaging system.

[0103] Method 800 concludes at block 820 with advancing, via the robotic surgical device coupled to the end effector of the capsulotomy tool, the end effector to an initial position adjacent to a first of the plurality of cutting sites along the cutting path.

[0104] FIG. 8B is a flow chart for a method of performing a capsulotomy procedure with a capsulotomy tool using an image-guided robotic system 801.

[0105] Method 801 begins at block 825 with operating an actuator coupled to the proximal end of the end effector to extend and withdraw the distal end of end effector through the surface of the anterior capsule of the eye to produce a controlled longitudinal cutting action of the end effector at the first of the plurality of cutting sites along the cutting path.

[0106] Method 801 continues at block 830 with indexing and advancing the capsulotomy tool via the robotic surgical device to a second of the plurality of cutting sites along the cutting path, via the robotic surgical device.

[0107] Next, at block 835, method 801 continues with extending a distal end of the end effector through the surface of the anterior capsule of the eye at the second of the plurality of cutting sites along the cutting path.

[0108] At block 840, method 801 involves withdrawing the distal end of the end effector above the surface of the anterior capsule of the eye adjacent to the second of the plurality of cutting sites along the cutting path.

[0109] Next, at block 845, method 801 progresses with indexing and advancing the capsulotomy tool to a third of the plurality of cutting sites along the cutting path, via the robotic surgical device.

[0110] Finally, at block 850, method 801 concludes with repeating the extending, withdrawing, indexing and advancing steps until the capsulotomy tool has moved through an entirety of the plurality of cutting sites along the cutting path.

[0111] According to certain examples of methods 800-801, the methods further include adjusting, via the robotic surgical device, one or more of: (i) operating properties ofthe capsulotomy tool and (ii) the cutting path, based on the imaging data received from the imaging system in real-time as the capsulotomy tool progresses along the cutting path.

[0112] According to certain examples of methods 800-801, the actuator is adapted to oscillate the end effector within the shaft, in which the oscillation of the end effector is generated by longitudinal motion of the shaft at the proximal end of the end effector, in which the longitudinal motion of the shaft at the proximal end of the end effector is propagated to the distal end of the end effector.

[0113] According to certain examples of methods 800-801, the end effector is a needle comprised of one or more of nickel, titanium and tungsten, in which the distal end of the end effector is flexible for confirming to the curvature of the sheath bent distal end or within an angle from 60 degrees to 90 degrees.

[0114] According to certain examples of methods 800-801, the end effector is encapsulated within a lumen formed in a flexible intermediary layer inside of the sheath lumen. The centering tube is configured to adapt to a degree of the pre-curved end portion of the tool sheath. The centering insert or the lubricious intermediary layer is a tube, one exemplary lubricious material is polyetheretherketone (PEEK).

[0115] According to certain examples of methods 800-801, the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the end effector relative to the surface of the eye , (ii) an oscillation frequency of the end effector, and (iii) a stroke rate of the capsulotomy tool.

[0116] According to certain examples of methods 800-801, the cutting path is a circular path comprised of a plurality of uniform overlapping circular perforations.

[0117] According to certain examples of methods 800-801, an interval between adjacent engagement points of the end effector to form the plurality of uniform overlapping circular perforations may vary with some spacing provided where adjacent apertures overlap between 10% to 90% of the diameter of an individual aperture formed by the end effector.

[0118] According to certain examples of methods 800-801, the cutting path including the overlap of the plurality of uniform overlapping circular perforations is adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

[0119] According to certain examples of methods 800-801, the robotic surgical device includes serial linkages and a remote center of motion (RCM).

[0120] According to certain examples of methods 800-801, the digital microscope is one or more of a stereo digital microscope and a telecentric digital microscope.

[0121] According to certain examples of methods 800-801, the end effector is configured to be retracted towards and extended away from the sheath between cutting one or more of the plurality of uniform overlapping circular perforations of the cutting path.

[0122] According to certain examples of method 800-801, the capsulotomy tool may be any of the capsulotomy tools previously described.

[0123] It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0124] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0125] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.

[0126] While various embodiments have been described and / or illustrated herein in the context of fully functional computing systems, one or more of these example embodiments may be distributed as a program product in a variety of forms, regardless of the particular type of computer-readable media used to actually carry out the distribution. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script, batch, or other executable files that may be stored on a computer-readable storage medium or in a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the example embodiments disclosed herein.

[0127] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.

[0128] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0129] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0130] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatiallyrelative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0131] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.

[0132] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0133] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

[0134] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the"less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0135] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0136] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

CLAIMSWhat is claimed is:

1. An image-guided robotic surgical system configured for a capsulotomy procedure, comprising: a capsulotomy tool comprising: a sheath having a proximal end and a curved distal end and a lumen extending from the proximal end to the distal end; an end effector having a proximal end and a distal end, the distal end configured as a flexible perforating element, the end effector within the lumen; an actuator coupled to the proximal end of the sheath adapted to oscillate the end effector within the lumen of the sheath to produce a controlled oscillating motion of the end effector flexible perforating element adapted and configured for controlled cutting and forming an opening in an anterior capsule of the eye; an imaging system comprising: optical coherence tomography (OCT) configured to scan the anterior capsule of the eye, and a digital microscope configured to visualize and record imaging data of the eye; and a robotic surgical device configured to maneuver the capsulotomy tool to perform the capsulotomy procedure along on a cutting path of overlapping perforations derived from imaging data received from the imaging system, wherein one or more of operating properties of the capsulotomy tool and the cutting path are adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

2. The system of claim 1, wherein the oscillation of the end effector is generated by longitudinal motion of the shaft at the proximal end of the end effector, wherein the longitudinal motion of the shaft at the proximal end of the end effector is propagated to the distal end of the end effector.

3. The system of claim 1, wherein the end effector has a shaft comprised of one or a combination of nickel, titanium and tungsten and the end effector distal end is sufficiently flexible to mimic the curvature of the tool sheath distal end.

4. The system of claim 1, wherein a portion of the distal end of the end effector is within a flexible intermediary layer inside of the sheath lumen configured to adapt to the curvature of the distal end of the tool shaft, optionally the flexible intermediary layer is a tube comprised of a lubricious material such as polyetheretherketone (PEEK).

5. The system of claim 1, wherein the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the tool sheath relative to the surface of the eye, (ii) an oscillation frequency of the end effector, and (iii) a stroke length of the distal end of the end effector.

6. The system of claim 1, wherein the cutting path is a generally circular path comprised of a plurality of uniform or substantially uniform or pre-determined overlapping perforations.

7. The system of claim 6, wherein an interval between adjacent engagement points of the end effector to form the plurality of overlapping perforations may vary with some spacing provided where adjacent perforations overlap between 10% to 90% of the diameter of an individual perforation formed by the perforating end effector.

8. The system of claim 6, wherein the cutting path including the overlap of the plurality of overlapping perforations is adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

9. The system of claim 1, wherein the robotic surgical device includes serial linkages and a remote center of motion (RCM).

10. The system of claim 1, wherein the digital microscope is one or more of a stereo digital microscope and a telecentric digital microscope.

11. The system of claim 6, wherein the distal most end portion of the perforating end effector is configured to be retracted towards and extended away from the distal end of the sheath between cutting one or more of the plurality of overlapping perforations of the cutting path.

12. A capsulotomy tool, comprising: a disposable tool portion, comprising: a sheath having a proximal end, a curved distal end and a lumen extending from the proximal end to the distal end, and a perforating end effector having a shaft with a flexible distal end, wherein the end effector is within the sheath lumen and the flexible distal end is adapted and configured for controlled cutting of a surface an anterior capsule of the eye; and a reusable tool holder and actuator portion releasably coupled to the proximal end of the tool sheath and comprising an actuator, the actuator adapted to drive the flexible distal end to produce a controlled oscillating motion of the flexible distal end of the end effector.

13. The capsulotomy tool of claim 12, adapted and configured for handheld use.

14. The capsulotomy tool of claim 12, adapted and configured for use in a robotically controlled surgery system.

15. The capsulotomy tool of claim 12, wherein the actuator of the reusable tool holder and actuator portion is adapted to oscillate the end effector within the tool sheath, wherein the oscillation of the perforating distal end is generated by longitudinal motion of the end effector shaft.

16. The capsulotomy tool of claim 12, wherein the perforating end effector is comprised of one or more of nickel, titanium and tungsten, wherein the distal end of the perforating end effector is adapted for motion along the angulation of the sheath curved distal end between 60 degrees and 90 degrees.

17. The capsulotomy tool of claim 12, wherein the end effector is within a lumen in flexible intermediary layer inside of the sheath sized to adapt movement of the perforating distal end along the curvature of the sheath, wherein the flexible intermediary layer is a tube comprised of poly etheretherketone (PEEK).

18. The capsulotomy tool of claim 12, wherein the disposable tool portion and reusable tool holder and actuator portion are coupled via magnetically coupling between a tool-side magnet and a tool holder-side magnet, further wherein the coupling is secured via a compression spring configured to be compressed.

19. The capsulotomy tool of claim 12, further comprising a gap between the proximal end and flexible distal end of the shaft of the perforating end effector, wherein the perforating end effector is configured to traverse the gap, wherein the gap corresponds to a stroke length of the end effector, wherein the stroke length is 400pm-1200pm.

20. The capsulotomy tool of claim 12, further comprising an external sheath of the disposable tool portion having and an inner diameter of 0.80-1.30mm; wherein an outer diameter of the proximal end of the sheath is 0.75-1.25 mm.

21. A method of forming an opening in an anterior capsule of an eye, comprising: gathering imaging data of the eye from an imaging system comprising optical coherence tomography (OCT) configured to scan the anterior capsule of the eye and a digital microscope configured to visualize and record imaging data of the eye; positioning a capsulotomy tool relative to the surface of the anterior capsule of eye via a robotic surgical device, the capsulotomy tool having a shaft and an end effector at least partially housed within the shaft; determining a cutting path having a plurality of cutting sites on the surface of the anterior capsule of the eye, based on the imaging data from the imaging system; advancing, via the robotic surgical device coupled to the end effector, the end effector to an initial position adjacent to a first of the plurality of cutting sites along the cutting path; operating an actuator coupled to the proximal end of the end effector to extend and withdraw the distal end of end effector through the surface of the anterior capsule of the eye to produce a controlled oscillating longitudinal cutting action of the end effector at the first of the plurality of cutting sites along the cutting path; indexing and advancing the capsulotomy tool via the robotic surgical device to a second of the plurality of cutting sites along the cutting path, via the robotic surgical device; extending a distal end of the end effector through the surface of the anterior capsule of the eye at the second of the plurality of cutting sites along the cutting path; withdrawing the distal end of the end effector above the surface of the anterior capsule of the eye adjacent to the second of the plurality of cutting sites along the cutting path; indexing and advancing the capsulotomy tool to a third of the plurality of cutting sites along the cutting path, via the robotic surgical device; andrepeating the extending, withdrawing, indexing and advancing steps until the capsulotomy tool has moved through an entirety of the plurality of cutting sites along the cutting path.

22. The method of claim 21, further comprising adjusting, via the robotic surgical device, one or more of: (i) operating properties of the capsulotomy tool and (ii) the cutting path, based on the imaging data received from the imaging system in real-time as the capsulotomy tool progresses along the cutting path.

23. The method of 21, wherein the actuator is adapted to oscillate the end effector within the shaft, wherein the oscillation of the end effector is generated by longitudinal motion of the shaft at the proximal end of the end effector, wherein the longitudinal motion of the shaft at the proximal end of the end effector is propagated to the distal end of the end effector.

24. The method of claim 21, wherein the end effector is a comprised of one or more of nickel, titanium and tungsten, wherein the distal end of the end effector is flexible for bending between 60 degrees and 90 degrees according to the curvature of the sheath distal end.

25. The method of claim 21, wherein the end effector is moving relative to an intermediary layer inside of the sheath lumen for centering the distal end portion within the sheath curved distal end.

26. The method of claim 21, wherein the operating properties of the capsulotomy tool include one or more of: (i) a positioning and maneuvering speed of one or more of (a) the shaft, (b) the end effector, and (c) an angle of the distal end of the end effector relative to the surface of the eye , (ii) an oscillation frequency of the end effector, and (iii) a stroke rate of the capsulotomy tool.

27. The method of claim 21, wherein the cutting path is a circular path comprised of a plurality of uniform overlapping circular perforations.

28. The method of claim 27, wherein an interval between adjacent engagement points of the end effector to form the plurality of uniform overlapping circular perforations may varywith some spacing provided where adjacent apertures overlap between 10% to 90% of the diameter of an individual aperture formed by the end effector.

29. The method of claim 27, wherein the cutting path including the overlap of the plurality of uniform overlapping circular perforations is adjusted based on the data received from the imaging system in real-time as the capsulotomy procedure progresses.

30. The method of claim 21, wherein the robotic surgical device includes serial linkages and a remote center of motion (RCM).

31. The method of claim 21, wherein the digital microscope is one or more of a stereo digital microscope and a telecentric digital microscope.

32. The method of claim 27, wherein the end effector is configured to be retracted towards and extended away from the sheath between cutting one or more of the plurality of uniform overlapping circular perforations of the cutting path.

33. The system of claim 1, wherein the capsulotomy tool is any of the capsulotomy tools of claims 12-20.

34. The method of any one of claims 21-32, wherein the capsulotomy tool is the capsulotomy tool of any one of claims 12-20.

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