WO2024097895A1 - Capsulotomy tool and method - Google Patents

Abstract

A capsulotomy tool having an end effector 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 motion of the end effector. The controlled motion is adapted and configured for directing the controlled cutting to create an opening in an anterior capsule of the eye.

Description

CAPSULOTOMY TOOL AND METHOD

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/382,088, filed November 2, 2022, entitled “CAPSULOTOMY TOOL AND METHOD,” which is incorporated herein by reference for all purposes.

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 exemplary system named “Zepto” is a pulsed-based technology used to perform the capsulotomy. This system provides inconsistent results, uses expensive hardware, and presents a further clinical risk of putting excess stress on the zonules if not properly used. Another exemplary system known as Femtosecond laser-assisted capsulotomy (FLACS) is a commercially available system offered as part of premium care treatment. The cost of this system has prevented more widespread acceptance. Still another conventional system relies on a variety of plasma blade technologies including the “Fugo Plasma Blade Ablation Capsulotomy”. This procedure and other related procedures were conceived nearly two decades ago but also has not enjoyed widespread acceptance in this case 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.

SUMMARY OF THE DISCLOSURE

[0008] Described herein are a variety of capsulotomy tools having a needle or cutting tool end effector on the distal end of a shaft and a motor driver on the shaft adapted to drive the needle end effector in a controlled motion adapted and configured for creating an opening in the anterior capsule of an eye. The capsulotomy tool may be adapted and configured for handheld use. Optionally, the capsulotomy tool may be adapted and configured for use in a 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] In various aspects, there is provided a capsulotomy tool having a shaft with a proximal end and a distal end. There is an end effector adjacent the distal end of the shaft wherein in use within an eye the end effector is adapted and configured for controlled cutting of a surface an anterior capsule of the eye. An actuator is coupled to the proximal end of the shaft, the actuator adapted to drive the shaft 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. Embodiments of the capsulotomy tool may be adapted and configured for handheld use or for use in a robotically controlled surgery system. In other embodiments, the capsulotomy tool end effector is any of a saw, a needle, a hollow needle, a needle with a partially roughened surface, a cutting element, a blade, or an implement adapted and configured for controlled cutting of a surface of the eye. More particularly, the end effector is a needle extending from a bottom surface of the shaft. Optionally, the needle may extend from the shaft distal end at a right angle or at an obtuse angle. Still other embodiments include the needle having a shaft and a cutting tip with a cutting tip that is one of a bevel tip, a franseen tip, a diamond tip, and a conical tip. Still further, the capsulotomy tool needle cutting tip may be a straight tip, a pre-bent tip or a pre-curved tip. Advantageously, the capsulotomy tool shaft has a square cross section, a rectangular cross section, a circular cross section or an oval cross section. In still other variations, the capsulotomy tool shaft and 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. [0010] 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 linear cutting action of the end effector. Thereafter, there is a step of manipulating a base on the proximal end of the shaft so that the end effector advances along the trajectory on the anterior capsule surface of the eye. In one alternative, the end effector is a needle at a right angle to the shaft or an obtuse angle to the shaft. In one variation, prior to the introducing step, there is a step of rotating the shaft of the capsulotomy tool to facilitate entry of the end effector through the surgical incision. In one embodiment, the trajectory comprises a series of openings formed in the anterior capsule indexed at a spacing of 0.2 to 0.5 micrometers. In still other variations, the interval between adjacent engagement points of the end effector may vary with some spacing provided where adjacent apertures 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 aperture formed by the end effector. In still other variations, the step of operating the actuator produces a movement of the end effector at a frequency of 0.01 to 50 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, less than 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 and specific anatomical structure of the eye undergoing treatment.

[0011] 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

[0012] 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: [0013] FIG. 1 A is a perspective view of a distal end of the capsulotomy tool in use within an eye.

[0014] FIG. IB is a top down view of FIG. 1 A showing the position of the distal end of the capsulotomy tool moving along a planned 6 mm diameter planned cut (red dashed lines). [0015] FIG. 2A is a perspective view of a distal portion of an embodiment of the capsulotomy tool.

[0016] FIG. 2B illustrates a number of different exemplary needle end effector shapes.

[0017] FIG. 3 A is an enlarged exemplary cross section view of a needle actuated by the capsulotomy tool just prior to making contact with the anterior capsule.

[0018] FIG. 3B is an enlarged exemplary cross section view of the needle and anterior capsule of FIG. 3 A when the downward stroke of the movement of the needle has been completed.

[0019] FIG. 3C is an enlarged exemplary cross section view of the needle and anterior capsule of FIG. 3B when the upward stroke of the movement of the needle has been completed. A first aperture formed in the anterior capsule is visible in this view.

[0020] FIG. 4 is a perspective view of the distal end of a capsulotomy tool embodiment with arrows indicating an exemplary linear cutting action or stroke of a needle at an obtuse angle to the tool shaft.

[0021] FIGS. 5 A and 5B illustrate a set up used during experimental proof of concept testing.

DETAILED DESCRIPTION

[0022] Embodiments of the capsulotomy tool of the present invention improve upon the existing systems by providing a needle-based end effector used to puncture the anterior capsule. The end effector may be controlled in such a way that the punctures or individual apertures 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 apertures 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 aperture formed by the end effector. In still another alternative, the adjacent apertures are in contact or are spaced apart 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 eye. 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 is vibrated or oscillated at a controlled frequency and magnitude relative to the anterior surface of the capsular bag. In one embodiment, the end effector is controlled to enable the needle to maintain an orientation in use that is perpendicular to the anterior surface of the capsular bag to produce the desired results. Orientations in various other angular relations may also be used and the angle of the end effector 120 may be variously positioned to provide the desired orientation.

[0023] FIGS. 1 A and IB represent an embodiment of the capsulotomy tool 100 in use during application, inside the eye 2. The eye 2 has a capsule 4, an iris 6 and cornea 8. A distal end portion of the tool shaft 106 and an end effector 120 has been inserted through a surgical incision 10. In this embodiment, the surgical incision is a corneal incision used to provide access to the intraocular space. The surgical incision may be any suitable shape or size. In general, the surgical incision 10 is slit having a width ranging from 2 mm to 3 mm or more particularly from 2.2 mm to 2.5 mm. Once the end effector is advanced through the surgical incision and in position, the capsulotomy tool 100 is actuated and moved through external means to trace a trajectory 14 (see FIG. IB), thereby creating the capsulotomy 12.

[0024] FIG. 1 A is a perspective view of a distal end 106 of the capsulotomy tool 100 in use within an eye 2. FIG. IB is a top-down view of FIG. 1 A showing the position of the distal end 106 of the capsulotomy tool 100 moving along a planned trajectory or pathway 14. In the illustrated embodiment, the cut trajectory or pathway is a 6 mm diameter planned cut (see dashed lines). The planned shape shown is circular and is exemplary. The planned shape of a trajectory or pathway 14 may vary in size and shape including regular, irregular or custom formed shapes based on the clinical need.

[0025] FIG. 2A is a perspective view of a distal portion of an embodiment of the capsulotomy tool 100. The capsulotomy tool 100 has a shaft 102 with a proximal end 104 and a distal end 106. The shaft 102 illustrated has a generally square cross section. Other cross section shapes such as rectangular, circular or oval are possible. This view provides additional details of the portion of the end effector beyond the base 115 and actuator 110. In the illustrated embodiment, the end effector 120 is a needle located at the distal end 106 on the underside of the shaft 102. The shaft itself is actuated in one embodiment by a motor as the actuator 110 coupled to base 115. A suitable handle (not shown) may also be provided to allow for hand held, robotic assisted or robotic used. Through the injected energy of the actuator 110, an angular vibration 20 of the shaft 102 is generated (see arrow across the shaft 102). This motion causes a linear cutting action 22 of the needle 120 at the end 106 of the shaft 102. Alternatively, the end effector can be driven internally to generate the puncture motion of the end effector. Different motions may be employed based on the cutting surface and shape of the end effector. In still other embodiments, a driver suited for the oscillation motion of the end effector may be provided that is suited for use in the eye. In the illustrative embodiment of FIG. 2 A the base and motor remain outside of the eye (see arrangement in FIG. 1 A). Additionally, the motion of the tool shaft 102 is selected to conform with the incision made in the eye to provide access to the needle and distal end of the end effector. In still further embodiments, the incision 10 formed in the eye to provide access for the capsulotomy tool may be modified based on the operating characteristics of the end effector and provide adequate envelope for operation of the needle end effector. Additionally or optionally, the end effector 102 and shaft 102 may be rotated or otherwise manipulated to facilitate atraumatic passage through the surgical incision 10 to access the interior of eye 2. [0026] Also shown in the view of FIG. 2 A is the angle 0 which is a right angle between the shaft and the end effector. Alternatively, as shown in FIG. 2B, the end effector may form an obtuse angle a between the tool shaft 102 and the shaft 122 of the end effector 120.

[0027] Still considering FIG. IB, this view provides a top view of the surgical workspace during use of an embodiment of the capsulotomy tool. By tracing a trajectory 14, the vibrating motion of the capsulotomy tool controllably and continuously drives the end effector 120 to puncture the anterior capsule. The result is the creation of a customized capsulotomy. The capsulotomy tool 100 can then be removed from the eye 2 after completion of the trajectory 14. It is to be appreciated that the needle or end effector 120 may be operated to create an anterior capsule opening customized based on a number of surgeon selected or clinical factors such as size, shape, centration, and location. It is to be appreciated that embodiments the inventive capsulotomy tool 100 are not constrained to only a circular trajectory. In other embodiments, the capsulotomy tool 100 is operated to provide a custom precision made opening that has been preselected, sized and shaped for subsequent surgical steps in a procedure.

[0028] In still other variations, the oscillation or vibration or induced motion 20 of the needle or end effector 120 may be generated using any suitable modality such as electrically, pneumatically, or piezoelectrically driven as provided by a suitably configured actuator 110. In still other variations, the size, shape, finish and other physical characteristics and designs of the needle or end effector 120 can be realized so long as the needle or other effector punctures or pierces or forms an aperture in the capsular bag.

[0029] In some embodiments, the needle or end effector 120 and drive control system may be adapted and configured for handheld use by a human surgeon with or without haptic feedback, with or without an image control or feedback system. In still further embodiments, the needle or other end effector 120 and capsulotomy tool 100 may be implemented in a fully robotic or partially robotic microsurgery system.

[0030] It is to be appreciated that the term needle refers to an end effector having a shaft 122 and a tissue engaging or cutting or piercing tip 124. The shaft 122 may be circular or have other shapes. The tip 124 may also be smooth, faceted or have an irregular arrangement of surfaces at the distal end. FIG. 2B includes four representative exemplary shaft 122 having a needle end effector tip shape designated (a)-(d). FIG. 2B(a) the tip 124 is a bevel tip. FIG. 2B(b) the tip 124 is an example of a franseen tip. FIG. 2B(c) the tip 124 is an example of a diamond tip. FIG. 2B(d) the tip 124 is an example of a conical tip. Other end effector 120 embodiments may have other shapes such as, for example and without limitation, lancet point, back bevel, trocar, including variations of straight tip, pre-bent tip or pre-curved tip. In still other aspects, the needle may be hollow or solid with an exterior surface that is polished or may have an abrasive finish. [0031] In use, the motion of the needle end effector of the capsulotomy tool provides a controlled method of puncturing the anterior capsule. Under the control of the user or control system, the motor driver induces movement of the needle end effector downwards by the mechanical motion/vibration of the shaft. Contact with the needle tip 124 and the surface of the anterior capsule results. Continued motion of the needle tip results in the puncture of the anterior capsule and formation of an aperture shaped similarly to the shaft of the needle end effector. Based on the desired pitch or distance of the downward needle movement, the needle will stop moving into the eye and reverse. The reverse step results in retraction of the needle to its original position above the surface of the anterior capsule. Indexing the needle to the next position for creation of an aperture in the anterior capsule allows the process of downward, contact and penetration through the anterior capsule, stopping at distal most end of downward motion and reversing to withdraw the needle to the starting position above the anterior capsule. As discussed further herein, the spacing of adjacent apertures or punctures in the tissue surface provided a form of perforation of the tissue whereby adjacent apertures overlap slightly. In one aspect, the amount of overlap is determined by advancing of the end effector along the desired trajectory indexed by some percentage of the diameter of the end effector. The series of images show in FIGS. 3A, 3B and 3C illustrate the basic process of forming an aperture using the end effector and then advancing to the next aperture based on the degree of perforation desired when following a specific path or trajectory 14. In these exemplary embodiments, the end effector 120 is a needle positioned on a bottom surface of a distal end portion 106 of a shaft of the capsulotomy tool.

[0032] FIG. 3A is an enlarged exemplary cross section view of a needle 120 actuated by the capsulotomy tool 100 just prior to making contact with the anterior capsule 4. As indicated by circled numeral 1, the needle is positioned to be at a right angle to the shaft as shown and described in FIG. 2A and is shown just prior to contact. This initial position would be determined by the trajectory or path 14. Circled number 2 indicates the motion of the arrow downward as a result of the operation of the actuator. [0033] FIG. 3B is an enlarged exemplary cross section view of the needle 120 and anterior capsule 4 of FIG. 3 A when the downward stroke (circled numeral 2) of the movement of the needle has been completed. An aperture or hole in the anterior capsule is visible in this view (adjacent circled number 3). In general, in some embodiments, the aperture will have a size and shape related to the size and shape of the needle or end effector shaft 122 and tip 124 used.

[0034] FIG. 3C is an enlarged exemplary cross section view of the needle and anterior capsule of FIG. 3B when the upward stroke of the movement of the needle has been completed (see circled numeral 4). The distal end of the needle 124 end effector is now in a position above the anterior capsule 4. A first aperture of the path or trajectory 14 is formed in the anterior capsule 4 is visible in this view. Next, as indicated by circled numeral 5, the distal end 106 of the tool shaft would advance into position such that the next downward action (circled number 2) would form the next aperture of the trajectory or path 14 at a desired location or degree of perforation relative to the initial or most recent perforation or aperture formed in the capsule 4.

[0035] FIG. 4 is a perspective view of the distal end 106 of another capsulotomy tool 100 configured similar to the embodiment of FIG. 2 A. The embodiment of FIG. 4 illustrates an end effector at an obtuse angle a relative to the bottom portion of the tool shaft 102. Additionally, as a result of this variation of end effector angle, there is produced a different kind of linear cutting motion 24 as the tool shaft 102 moves with the cyclic motion 20 (see arrows) indicating an exemplary linear cutting action or stroke of the needle. In some other embodiments, the needle end effector 120 may be at still other angles other than perpendicular (FIG. 2A) or the specific obtuse angle illustrated in FIG. 4. In some embodiments, the angle of the needle to the shaft is selected to provide a desired angle of contact with the surface of the anterior capsule. In some embodiments, the angle of the needle end effector to the shaft may be adjusted based on surgeon preference, patient anatomy or other factors in order to provide a desired impact profile for contact between the needle end effector tip and the anterior capsule surface.

[0036] FIG. 5 A illustrates a set up used during experimental proof of concept testing. In one exemplary embodiment, a needle end effector is operated for perforating the anterior capsule at a frequency from 0.01-50 kHz and indexed at a spacing from 0.2-0.5 micrometers. In another exemplary embodiment, the capsulotomy tool performs a complete cut in less than 10 seconds, less than 9 seconds, less than 8 seconds, less than 7 second or in less than 6 seconds. In another embodiment, the capsulotomy tool provides a visual-tactile-force feedback response to a user. In another embodiment the capsulotomy tool may be used for forming an opening ranging from 4-7 mm and sized and shaped for later intraocular lens (IOL) implantation procedure, including IOL specific overlap and shape characteristics and recommendations as well as accommodation for patient specific anatomy. [0037] In the proof-of-concept setup tested in FIG. 5 A. A needle (dimensioned as shown in FIG. 5B) was in a fixed position and a pig eye was rotated relative to the needle. The needle was under the control of the mechanical driver or actuator was positioned perpendicular to the capsule plane. The fixed mechanical driver moved the needle under different control conditions with various frequency and depth of motion below and above the capsule plane. As a result, it is believed that the resulting capsulotomy can have a predefined shape (circular or oval or approximate circular shape or other shapes based on procedural need) as well as centration and diameter as needed. FIG. 5 A illustrates the general arrangement used in the proof-of-concept demonstration where the eye (with cornea removed) was rotated under the needle driven by the mechanical driver.

[0038] FIG. 5B is an enlarged photo of the needle used in the experiment described in relation to FIG. 5 A. The needle used has a shaft diameter of 700 microns with a 16 degree angled tip. The proof-of-concept experiment demonstrated an ability to do a clean cut 6 mm diameter circumference within 6 sec, having a 0.25 micrometer spacing between adjacent needle holes. Based on the results achieved, it is believed that the mechanical integrity of the capsule is or may be maintained using either automated or manual progression of needle along the desired cutting pattern.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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 "/".

[0046] 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 spatially relative 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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

CLAIMS What is claimed is:

1. A capsulotomy tool, comprising: a shaft having a proximal end and a distal end; an end effector adjacent the distal end of the shaft wherein in use within an eye the end effector is adapted and configured for controlled cutting of a surface an anterior capsule of the eye; and an actuator coupled to the proximal end of the shaft, the actuator adapted to drive the shaft 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.

2. The capsulotomy tool of claim 1, adapted and configured for handheld use.

3. The capsulotomy tool of claim 1, adapted and configured for use in a robotically controlled surgery system.

4. The capsulotomy tool of claim 1, wherein the end effector is any of a saw, a needle, a hollow needle, a needle with a partially roughened surface, a cutting element, a blade, or an implement adapted and configured for controlled cutting of a surface of the eye.

5. The capsulotomy tool of claim 1, wherein the end effector is a needle extending from a bottom surface of the shaft.

6. The capsulotomy tool of claim 5, wherein the needle extends from the shaft distal end at a right angle or at an obtuse angle.

7. The capsulotomy tool of claims 5 or 6, the needle comprising a shaft and a cutting tip wherein the cutting tip is one of a bevel tip, a franseen tip, a diamond tip, and a conical tip.

8. The capsulotomy tool of claim 7, wherein the cutting tip is a straight tip, a pre-bent tip or a pre-curved tip.

9. The capsulotomy tool of any of the above claims wherein the shaft has a square cross section, a rectangular cross section, a circular cross section or an oval cross section.

10. The capsulotomy tool of any of the above claims wherein the shaft and 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.

11. A method of forming an opening in an anterior capsule of an eye, comprising: 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; advancing the shaft to place the end effector into on an initial position for cutting along a trajectory on an anterior capsule surface of the eye; operating an actuator coupled to the shaft to produce a controlled linear cutting action of the end effector; and manipulating a base on the proximal end of the shaft so that the end effector advances along the trajectory on the anterior capsule surface of the eye.

12. The method of claim 11, wherein the end effector is a needle at a right angle to the shaft or an obtuse angle to the shaft.

13. The method of claim 11, wherein prior to the introducing step there is a step of rotating the shaft of the capsulotomy tool to facilitate entry of the end effector through the surgical incision.

13. The method of claim 11, wherein the trajectory comprises a series of openings formed in the anterior capsule indexed at a spacing of 0.2 to 0.5 micrometers.

14. The method of claim 11, wherein the step of operating the actuator produces a movement of the end effector at a frequency of 0.01 to 50 Hz.

15. The method of any of claims 11-14, further comprising forming an opening in the anterior capsule sized from 4 mm to 7 mm.

16. The method of any of claims 11-15, further comprising forming an opening in the anterior capsule sized and shaped in preparation for a subsequent intraocular lens implantation procedure.

17. The method of any of claims 11-16, wherein the capsulotomy tool provides a visual- tactile-force feedback signal to a user or to a control system.

18. The method of any of claims 11-17, wherein the end effector completes the cutting along the trajectory in less than 9 seconds, less than 8 seconds, less than 7 seconds or less than 6 seconds.

19. The method of any of claims 11-18, performed using any capsulotomy tool of claims 1-

10 to produce a trajectory wherein the interval between adjacent engagement points of the end effector may vary with some spacing provided where adjacent apertures 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 aperture formed by the end effector.