Force feedback for robotic microsurgical procedures.

Abstract

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Apparatus and methods for performing procedures on a patient's eye are described. The robotic unit inserts an ophthalmic tool (21) into the eye through an incision in the cornea such that a tip of the ophthalmic tool (21) is located within the eye and a remote center of motion of the ophthalmic tool (21) is located within the incision. The robotic unit determines a position and orientation of a tip of a control component tool (32) based on data received from one or more position sensors (92, 94) and moves the tip of the ophthalmic tool (21) within the eye to match the movement of the control component tool (32). Feedback is provided to the operator indicating placement of the remote center of motion of the ophthalmic tool (21) relative to the incision. Other applications are also described.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 285,218, to Korman, entitled "Robotic unit for microsurgical procedures," filed on December 2, 2021, and U.S. Provisional Patent Application No. 63 / 406,881, to Golan, entitled "Force feedback for robotic microsurgical procedures," filed on September 15, 2022, both of which are incorporated herein by reference.

[0002] Some applications of the present invention relate generally to medical devices and methods, and more particularly, to devices and methods for performing robotic microsurgical procedures. [Background technology]

[0003] Cataract surgery consists of removing the eye's natural lens that has developed opacity (known as a cataract) and replacing it with an intraocular lens. Such surgery usually involves several standard steps that are performed in sequence.

[0004] In the first step, the patient's face around the eyes is disinfected (usually with an iodine solution) and the face is covered with a sterile drape to expose only the eye. Once disinfection and draping are complete, the eye is anesthetized using a local anesthetic, usually administered in the form of eye drops. The eye is then exposed using a retractor that holds the upper and lower eyelids open. One or more incisions (usually two or three incisions) are made in the cornea of ​​the eye. The incisions are usually made using a specialized blade called a keratome blade. At this stage, lidocaine is usually injected into the anterior chamber of the eye to further anesthetize the eye. Following this step, a viscoelastic injection is administered through the corneal incision. The viscoelastic injection is administered to stabilize the anterior chamber and to help maintain intraocular pressure for the remainder of the procedure, as well as to expand the lens capsule.

[0005] In a later step known as capsulorhexis, a portion of the anterior lens capsule is removed. Various enhanced techniques have been developed to perform capsulorhexis, including laser-assisted capsulorhexis, zepto-assisted incision (using precise nano-pulse technology), and marker-assisted capsulorhexis (where the cornea is marked using a defined marker to indicate the desired size for the capsule opening).

[0006] It is then common to inject a fluid wave through the corneal incision to slice through the outer layer of the cataract, in a step known as hydrodissection. In a subsequent step known as hydrodelineation, the outer, softer epi-nucleus of the lens is separated from the inner, harder endo-nucleus by injection of a fluid wave. The next step is ultrasonic emulsification of the lens in a process known as phacoemulsification. The nucleus of the lens is first fragmented using a chopper, after which the outer fragments of the lens are broken down and removed, usually using an ultrasonic phacoemulsification probe. A separate tool is also usually used to perform aspiration during phacoemulsification. Once phacoemulsification is complete, the remaining cortical (i.e., outer layer of the lens) material is aspirated from the capsule. During phacoemulsification and aspiration, the aspirated fluid is usually supplemented by irrigation with a balanced salt solution to maintain fluid pressure in the anterior chamber. In some instances, the capsule is polished if deemed necessary. An intraocular lens (IOL) is then inserted into the capsule. The IOL is usually foldable and inserted in a folded state, after which it is deployed inside the capsule. At this stage, the viscoelastic material is usually removed using a suction device that was previously used to aspirate the fluid from the capsule. If necessary, the incision is closed by increasing intraocular pressure, forcing the incision closed by pressing the inner tissue against the outer tissue. Summary of the Invention

[0007] According to some applications of the present invention, a robotic system is configured for use in microsurgical procedures, such as intraocular surgery. Typically, the robotic system includes one or more robotic units (configured to hold a tool) in addition to an imaging system, one or more displays, and a control component unit (e.g., a control component unit including a pair of control components such as a joystick) through which one or more operators (e.g., medical professionals such as doctors and / or nurses) can control the robotic units. Typically, the robotic system includes one or more computer processors through which the components of the system and the one or more operators operatively interact with each other. The scope of the present application includes mounting one or more robotic units in any of a variety of different positions from one another.

[0008] Typically, the movement of the robotic unit (and / or the control of other aspects of the robotic system) is controlled, at least in part, by one or more operators (e.g., medical professionals such as doctors and / or nurses). For example, the operator may receive, via a display, images of the patient's eye and the robotic unit and / or tools disposed therein. Based on the received images, the operator typically performs steps of the procedure. In some applications, the operator gives commands to the robotic unit via a control component unit. Typically, such commands include commands to control the position and / or orientation of tools disposed within the robotic unit and / or commands to control operations performed by the tools. For example, the commands may control a blade, a phacoemulsification tool (e.g., the operating mode and / or suction power of the phacoemulsification tool), and / or an injector tool (e.g., which fluid (e.g., viscoelastic fluid, saline, etc.) should be injected and / or at what flow rate). Alternatively or additionally, the operator may input commands to control the imaging system (e.g., the zoom, focus, and / or xy positioning of the imaging system). For some applications, the commands include controlling an intraocular lens manipulator tool to manipulate the intraocular lens within the eye, for example to precisely position the intraocular lens within the eye.

[0009] Typically, the control component unit includes one or more control component joysticks configured to correspond to each robotic unit of the robotic system. For example, the system may include a first and a second robotic unit, and the control component unit may include a first and a second joystick. Typically, each joystick is a control component arm including multiple links coupled to each other via joints. (The terms "joystick" and "control component arm" are used interchangeably in this disclosure.) In some applications, the control component joystick includes each control component tool (to replicate the robotic unit). Typically, a computer processor determines the XYZ position and orientation of the tip of the control component tool and drives the robotic unit such that the tip of the actual tool being used to perform the procedure tracks the movement of the tip of the control component tool. In some cases, the actual tool being used to perform the procedure is described herein and in the claims as an "ophthalmic tool." This term is used to distinguish between the actual tool being used to perform the procedure and the control component tool, and should not be construed in any way as limiting the type of tool that may be used. The term "ophthalmic tool" should be interpreted to include any one of the tools described herein or any other type of tool that may occur to one of ordinary skill in the art upon reading this disclosure.

[0010] Typically, during a cataract procedure, one or more incisions (usually two or three incisions) are made in the cornea of ​​the eye. The incisions are typically made using a specialized blade called a keratome blade. Typically, the robotic unit is configured to insert an ophthalmic tool into the patient's eye, such that entry of the ophthalmic tool into the patient's eye is through the incision in the cornea and the tip of the tool is positioned within the patient's eye. Furthermore, typically, the robotic system is configured to move the tip of the tool within the patient's eye to constrain entry of the tool into the patient's eye to remain within the incision.

[0011] To perform non-robotic anterior segment surgery, the surgeon typically makes one or more incisions in the patient's cornea, which then serves as an entry point for various surgical tools. The tools are inserted through the incisions and manipulated within the eye to achieve the surgical goal. During this manipulation, it is medically preferable that the tool not be pressed hard against the incision edges, nor be lifted up or pressed down too far. Such movements may tear the incision edges, thereby enlarging the incision and adversely affecting the surgical outcome. Ideally, the surgeon manipulates the tool at its entry point through the incision such that it rotates about the center of the incision but does not move laterally. Such movement of the tool at the incision is described herein as maintaining a center of motion. In robotic procedures as described herein, the above-mentioned tool movements are described as maintaining a remote center of motion. This is because the tools are typically controlled from a distance (e.g., by a control component unit). In non-robotic procedures, manually maintaining the center of motion can be difficult, especially when the surgeon needs to focus on the tool tip performing the current surgical procedure. According to some applications of the present invention, feedback is provided to assist the operator in performing robotic-assisted surgery. The feedback, typically provided by the control component unit (as described in more detail below), typically assists the operator in maintaining the remote center of motion of the ophthalmic tool by applying a force that counteracts any movement of the joystick and / or control component tool that the operator attempts to make that would result in a violation of the remote center of motion.

[0012] As mentioned above, in some applications, an operator provides commands to the robotic unit via the control component unit. Typically, such commands include commands to control the position and / or orientation of a tool disposed in the robotic unit and / or commands to control an operation performed by the tool. In some applications, the robotic unit is configured to move the tool's entry into the patient's eye within the incision, and the computer processor is configured to drive the output unit to provide feedback to the operator indicative of the tool's entry position within the incision into the patient's eye. For example, the computer processor may generate an output on a display indicative of the incision zone and the tool entry position within the incision zone. In some applications, an output, such as a visual or audio alert, is generated when the tool is moved such that the tool entry position into the patient's eye is within a given distance from the incision edge.

[0013] In some applications, the computer processor is configured to drive the control component unit to provide feedback to the operator indicative of the tool entry position within the incision into the patient's eye. For example, as the tool is moved such that the tool entry position within the patient's eye approaches the incision edge, the control component arm may be increased in resistance to movement and / or the control component arm may be vibrated and / or a different output may be generated. It is noted that according to some such applications of the present invention, the movement of the ophthalmic tool itself is not constrained to maintain a remote center of motion, and the tool may move freely. However, the control component unit provides force feedback (and / or other feedback) to the operator to assist the operator in moving the joystick and the control component tool such that the ophthalmic tool maintains a remote center of motion position within the incision or within the incision zone.

[0014] Thus, in accordance with some applications of the present invention, there is provided an apparatus for performing a procedure on a patient's eye with an ophthalmic tool having a distal tip, the apparatus comprising: a robotic unit configured to move an ophthalmic tool; A control component unit, a control component tool configured to be moved by an operator and defining a tip; at least one control component arm coupled to the control component tool and including one or more position sensors; A control component unit including: 1. A computer processor comprising: driving the robotic unit to insert an ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; determining a position and orientation of the tip of the control component tool based on data received from the one or more position sensors; moving a tip of an ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; providing feedback to the operator indicative of placement of the remote center of motion of the ophthalmic tool relative to the incision; a computer processor configured to: Includes.

[0015] In some applications, the control component arm includes a plurality of links interconnected via rotating arm joints, and the one or more position sensors three rotary encoders, each coupled to a respective one of the rotary arm joints and configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0016] In some applications, the control component arm includes a plurality of links coupled to each other via rotary arm joints, the control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of an XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0017] In some applications, the computer processor is configured to provide feedback to the operator indicating the location of the remote center of motion of the ophthalmic tool relative to the incision by generating an alert when the ophthalmic tool is moved such that the remote center of motion of the ophthalmic tool is within a given distance from the edge of the incision.

[0018] In some applications, the computer processor is configured to generate an audio alert.

[0019] In some applications, the computer processor is configured to generate a visual alarm.

[0020] In some applications, the computer processor is configured to provide force feedback to the operator via the control component arm, thereby providing feedback to the operator indicative of the placement of the remote center of motion position of the ophthalmic tool relative to the incision.

[0021] In some applications, the computer processor: determining the identity of an ophthalmic tool inserted into the patient's eye; Calculating a location of a remote center of motion location of the ophthalmic tool relative to the incision based on the identity of the ophthalmic tool; It is structured as follows.

[0022] In some applications, the computer processor: Perform speed measurements on control component tools, Calculating the force applied to the operator based on the velocity measurements; Drives the control components to apply the calculated forces to the operator by providing force feedback to the operator via the control component.

[0023] In some applications, the computer processor: Taking measurements of the position of the ophthalmic tool relative to the incision; Calculating a force applied to the operator based on the position measurements; Control component drives the arm to apply calculated forces to the operator by providing force feedback to the operator via the control component arm.

[0024] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating a force that is equal and opposite to the force applied by the operator to the control component tool.

[0025] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating the force as proportional to the distance from the center of the incision to the outer edge of the ophthalmic tool.

[0026] For some applications, the computer processor is configured to receive input from an operator indicating a stiffness of force feedback that the operator desires to receive, and to calculate a force to be applied to the operator based at least in part on the input from the operator.

[0027] In some applications, the computer processor is configured to constrain the movement of the control component tool to correspond to how the movement of the remote center of motion position of the ophthalmic tool relative to the incision should be constrained.

[0028] For some applications, the computer processor is configured to constrain movement of the control component tool to constrain the remote center of motion position of the ophthalmic tool to remain within an incision zone that is larger than the incision.

[0029] For some applications, the computer processor is configured to constrain movement of the control component tool to constrain a remote center of motion position of the ophthalmic tool to remain within the incision.

[0030] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating a force function based on the distance of an outer edge of the ophthalmic tool in two directions from the center of the incision.

[0031] In some applications, a first of the two directions is parallel to the incision and tangent to the cornea of ​​the patient's eye at the incision, and a second of the two directions is perpendicular to the first direction and tangent to the cornea of ​​the patient's eye at the incision.

[0032] In some applications, the control component arm includes a plurality of links interconnected via rotating arm joints and one or more motors operably coupled to each rotating arm joint; The computer processor is configured to provide force feedback to an operator by driving a control component arm with a plurality of motors.

[0033] In some applications, the control component arm includes three motors operably coupled to each joint.

[0034] In some applications, the control component arm includes a belt and at least one of the motors is operably coupled to a corresponding one of the rotating arm joints via the belt such that at least one of the motors is positioned closer to the base of the control component unit than if at least one of the motors directly drove the corresponding one of the rotating arm joints.

[0035] In some applications, a majority of the one or more motors directly drive a corresponding one of the rotating arm joints to which they are operatively coupled.

[0036] In some applications, the one or more position sensors may include: three rotary encoders, each coupled to a respective one of the rotary arm joints and configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0037] In some applications, the control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of an XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0038] Further, in accordance with some applications of the present invention, there is provided an apparatus for performing a procedure on a patient's eye with an ophthalmic tool having a distal tip, the apparatus comprising: a robotic unit configured to move a tool; A control component unit, a control component tool configured to be moved by an operator and defining a tip; a control component arm coupled to the control component tool, A plurality of links connected to each other via rotating arm joints; one or more position sensors; one or more motors operably coupled to each rotating arm joint; a control component arm including: A control component unit including: 1. A computer processor comprising: Actuating the robotic unit to insert an ophthalmic tool into the patient's eye through the corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye; determining a position and orientation of the tip of the control component tool based on data received from the one or more position sensors; moving the tip of the selected ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; Providing force feedback to an operator by driving a control component arm using multiple motors; a computer processor configured to: Includes.

[0039] In some applications, the control component includes three motors operably coupled to each rotating arm joint.

[0040] In some applications, the control component arm includes a belt and at least one of the motors is operably coupled to a corresponding one of the rotating arm joints via the belt such that at least one of the motors is positioned closer to the base of the control component unit than if at least one of the motors directly drove the corresponding one of the rotating arm joints.

[0041] In some applications, a majority of the one or more motors directly drive a corresponding one of the rotating arm joints to which they are operatively coupled.

[0042] In some applications, the one or more position sensors may include: three rotary encoders, each coupled to a respective one of the rotary arm joints and configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0043] In some applications, the control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of an XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; Includes.

[0044] In some applications, the computer processor: driving the robotic unit to insert an ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; providing force feedback to the operator indicative of the placement of the remote center of motion of the ophthalmic tool relative to the incision; It is structured as follows.

[0045] In some applications, the computer processor: determining the identity of an ophthalmic tool inserted into the patient's eye; Calculating a location of a remote center of motion location of the ophthalmic tool relative to the incision based on the identity of the ophthalmic tool; It is structured as follows.

[0046] In some applications, the computer processor: Perform speed measurements on control component tools, Calculating the force applied to the operator based on the velocity measurements; Drives a control component to apply a calculated force to the operator via one or more motors by providing force feedback to the operator via the control component.

[0047] In some applications, the computer processor: Taking measurements of the position of the ophthalmic tool relative to the incision; Calculating a force applied to the operator based on the position measurements; Drives the control components to apply the calculated forces to the operator by providing force feedback to the operator via the control component.

[0048] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating a force that is equal and opposite to the force applied by the operator to the control component tool.

[0049] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating the force as proportional to the distance from the center of the incision to the outer edge of the ophthalmic tool.

[0050] For some applications, the computer processor is configured to receive input from an operator indicating a stiffness of force feedback that the operator desires to receive, and to calculate a force to be applied to the operator based at least in part on the input from the operator.

[0051] In some applications, the computer processor is configured to constrain the movement of the control component tool to correspond to how the movement of the remote center of motion position of the ophthalmic tool relative to the incision should be constrained.

[0052] For some applications, the computer processor is configured to constrain movement of the control component tool to constrain the remote center of motion position of the ophthalmic tool to remain within an incision zone that is larger than the incision.

[0053] For some applications, the computer processor is configured to constrain movement of the control component tool to constrain a remote center of motion position of the ophthalmic tool to remain within the incision.

[0054] In some applications, the computer processor is configured to calculate the force applied by the operator by calculating a force function based on the distance of an outer edge of the ophthalmic tool in two directions from the center of the incision.

[0055] In some applications, a first of the two directions is parallel to the incision and tangent to the cornea of ​​the patient's eye at the incision, and a second of the two directions is perpendicular to the first direction and tangent to the cornea of ​​the patient's eye at the incision.

[0056] Further, in accordance with some applications of the present invention, there is provided an apparatus for performing a procedure on a patient's eye using a plurality of ophthalmic tools, each having a distal tip. The apparatus includes: a robotic unit configured to move an ophthalmic tool; 1. A computer processor comprising: activating the robotic unit to insert a selected one of the ophthalmic tools into the patient's eye through a corneal incision of the patient's eye such that a tip of the selected ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; determining the identity of an ophthalmic tool inserted into the patient's eye; Calculate a location of a remote center of motion location of the ophthalmic tool relative to the incision based on the identity of the selected ophthalmic tool; providing feedback to the operator indicative of placement of the remote center of motion position of the selected ophthalmic tool relative to the incision; a computer processor configured to: Includes.

[0057] In some applications, a method is provided for performing a procedure on a patient's eye with an ophthalmic tool having a tip, the method comprising: driving the robotic unit to insert an ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; determining a position and orientation of a tip of a control component tool based on data received from one or more position sensors disposed on a control component arm coupled to the control component tool configured to be moved by an operator; moving a tip of an ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; providing feedback to an operator indicative of a location of a remote center of motion position of the ophthalmic tool relative to the incision; Includes.

[0058] Additionally provided is a method for performing a procedure on a patient's eye with an ophthalmic tool having a tip, the method comprising: driving the robotic unit to insert an ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; determining a position and orientation of a tip of a control component tool based on data received from one or more position sensors disposed on a control component arm coupled to the component tool configured to be moved by an operator; moving a tip of an ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; and providing force feedback to the operator via a control component arm including a plurality of links interconnected via rotating arm joints and one or more motors operably coupled to each rotating arm joint, wherein the force feedback is provided to the operator by driving the control component arm with the plurality of motors.

[0059] Further, in accordance with some applications of the present invention, there is provided a method for performing a procedure on a patient's eye with a plurality of ophthalmic tools, each having a tip, the method comprising: driving the robotic unit to insert an ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion position of the ophthalmic tool is positioned within the incision; determining the identity of an ophthalmic tool inserted into the patient's eye; Calculating a location of a remote center of motion location of the ophthalmic tool relative to the incision based on the identity of the selected ophthalmic tool; providing feedback to the operator indicative of placement of a remote center of motion position of the selected ophthalmic tool relative to the incision; Includes.

[0060] Further, in accordance with some applications of the present invention, there is provided an apparatus for performing robotic microsurgery on a patient's eye using one or more tools, the apparatus comprising: An end effector; a tool mount coupled to the end effector and configured to securely hold one or more tools; one or more robotic arms coupled to the end effector and configured to control yaw and pitch angle rotation of one or more tools, such that a tip of the tool held by a tool mount moves in a desired manner within the patient's eye while maintaining an entry position of the tool into the patient's eye within a dissection zone, the dissection zone being greater than 150 percent of a maximum cross-section of the tool penetrating the dissection zone; a control component configured to be moved by an operator to cause a desired movement of the tool; an output unit configured to provide feedback to an operator indicative of a position of the entry position of the tool into the patient's eye within the incision zone; Includes.

[0061] In some applications, the output unit includes a display indicating the dissection zone and the entry position of the tool within the dissection zone.

[0062] For some applications, the output unit includes an output unit configured to generate an alarm when the tool is moved such that an entry position of the tool into the patient's eye approaches an edge of the incision zone.

[0063] In some applications, the output unit includes a portion of the control component configured to provide haptic feedback to an operator.

[0064] For some applications, the control component is configured to increase resistance to movement of the control component as an entry position of the tool into the patient's eye approaches an edge of the incision zone.

[0065] The present invention will be more fully understood from a consideration of the following detailed description of the embodiments in conjunction with the accompanying drawings. [Brief description of the drawings]

[0066] [Figure 1] FIG. 1 is a schematic diagram of a robotic system configured for use in microsurgical procedures, such as intraocular surgery, in accordance with some applications of the present invention. [Diagram 2] 1 is a schematic diagram of an incision in a patient's cornea, in accordance with some applications of the present invention. [Figure 3A] 1 is a schematic diagram of a tool inserted through a patient's cornea, in accordance with some applications of the present invention, where the tip of the tool is moved as desired within the patient's eye while the tool entry position into the patient's eye is maintained within the incision zone. [Figure 3B] 1 is a schematic diagram of a tool inserted through a patient's cornea, in accordance with some applications of the present invention, where the tip of the tool is moved as desired within the patient's eye while the tool entry position into the patient's eye is maintained within the incision zone. [Figure 4A] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4B] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4C] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4D] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4E] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4F] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4G] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4H] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Figure 4I] 11 is a graph graphically illustrating the feedback force provided by the control component unit to an operator as a function of distance of a portion of the tool from the center of an incision in a subject's cornea, in accordance with an application of the present invention. [Diagram 5] 4 is a flow chart illustrating the steps of procedures according to some applications of the present invention. [Figure 6A] 1 is a schematic diagram of a joystick and control component tool according to some applications of the present invention. [Figure 6B] 1 is a schematic diagram of a joystick and control component tool according to some applications of the present invention. [Figure 6C] 1 is a schematic diagram of a joystick and control component tool according to some applications of the present invention. [Figure 7] FIG. 2 is a schematic diagram of some additional components of a control component joystick according to some applications of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] Reference is now made to FIG. 1, which is a schematic diagram of a robotic system 10 configured for use in microsurgical procedures, such as intraocular surgery, in accordance with some applications of the present invention. Typically, when used in intraocular surgery, the robotic system 10 includes one or more robotic units 20 (configured to hold a tool 21), in addition to an imaging system 22, one or more displays 24, and a control component unit 26 (e.g., a control component unit including a pair of control components, such as a joystick 30, shown in the enlarged portion of FIG. 1), through which the robotic unit 20 can be controlled by one or more operators 25 (e.g., medical professionals such as doctors and / or nurses). Typically, the robotic system 10 includes one or more computer processors 28, through which the components of the system and the one or more operators 25 operatively interact with each other. The scope of the present application includes mounting one or more robotic units in any of a variety of different locations from one another.

[0068] Typically, the movement of the robotic unit (and / or the control of other aspects of the robotic system) is controlled, at least in part, by one or more operators 25 (e.g., medical professionals such as doctors and / or nurses). For example, the operator may receive, via the display 24, images of the patient's eye and the robotic unit and / or tools disposed therein. Typically, such images are captured by the imaging system 22. In some applications, the imaging system 22 is a stereoscopic imaging device and the display 24 is a stereoscopic image display. Based on the received images, typically the operator performs steps of the procedure. In some applications, the operator gives commands to the robotic unit via the control component unit 26. Typically, such commands include commands to control the position and / or orientation of tools disposed within the robotic unit and / or commands to control operations performed by the tools. For example, the commands may control the blades, the phacoemulsification tool (e.g., the operating mode and / or suction power of the phacoemulsification tool), and / or the injector tool (e.g., which fluid (e.g., viscoelastic fluid, saline, etc.) should be injected and / or at what flow rate). Alternatively or additionally, the operator can enter commands to control the imaging system (e.g., zoom, focus, and / or xy positioning of the imaging system). In some applications, the commands include controlling an intraocular lens manipulator tool to manipulate the intraocular lens within the eye, for example, to precisely position the intraocular lens within the eye.

[0069] Typically, the control component unit includes one or more control component joysticks 30 configured to correspond to each robot unit 20 of the robot system. For example, as shown, the system includes a first and a second robot unit, and as shown, the control component unit can include a first and a second joystick. Typically, each joystick is a control component arm including multiple links interconnected by joints. This is described in more detail below with reference to Figures 6A to 7. In some applications, as shown in Figure 1, the control component joystick includes each control component tool 32 (to replicate the robot unit). Typically, a computer processor determines the XYZ position and orientation of the tip of the control component tool 32 and drives the robot unit such that the tip of the actual tool 21 being used to perform the procedure follows the movement of the tip of the control component tool. In some cases, the tool 21 is described herein and in the claims as an "ophthalmic tool". This term is used to distinguish between the tool 21 and the control component tool 32, and should not be construed in any way as limiting the type of tool that may be used as the tool 21. The term "ophthalmic tool" should be interpreted to include any one of the tools described herein or any other type of tool that may occur to one of ordinary skill in the art upon reading this disclosure.

[0070] Reference is now made to FIG. 2, which is a schematic diagram of an incision 40 in a patient's cornea 42, according to some applications of the present invention. As described above in the Background section, typically during a cataract procedure, one or more incisions (usually two or three incisions) are made in the cornea of ​​the eye. The incisions are typically made using a specialized blade called a keratome blade. Typically, the robotic unit is configured to insert a tool 21 into the patient's eye, such that the tool's entry into the patient's eye is made through the incision 40 and the tip of the tool is positioned within the patient's eye. More typically, the robotic system 10 is configured to move the tip of the tool within the patient's eye to constrain the tool's entry into the patient's eye to remain within the incision. In some applications, the width of the incision is equal to the width of the keratome blade. An incision center point 43 (marked in FIG. 2) is thereby defined as the point on the corneal surface that is centered within the incision width. In Figure 2, axes have been added: the x-axis is parallel to the incision and is tangent to the cornea at the incision, and the y-axis is perpendicular to the x-axis and is tangent to the cornea at the incision. Examples of the invention are described below with reference to the x-axis and y-axis.

[0071] To perform non-robotic anterior segment surgery, the surgeon typically makes one or more incisions in the patient's cornea, which then serves as an entry point for various surgical tools. The tools are inserted through the incisions and manipulated within the eye to achieve the surgical goal. During this manipulation, it is medically preferable that the tool not be pressed hard against the incision edges and not be lifted upward or pressed downward excessively. Such movements may tear the incision edges, thereby enlarging the incision and adversely affecting the surgical outcome. Ideally, the surgeon manipulates the tool at its entry point through the incision such that it rotates about the center of the incision but does not move laterally. Such movements of the tool at the incision are described herein as maintaining a center of motion. In a robotic procedure as described herein, the movements of the tool 21 described above are described as maintaining a remote center of motion, since the tool is typically controlled from a distance (e.g., by the control component unit 26). In non-robotic procedures, manually maintaining the center of motion can be difficult, especially when the surgeon needs to focus on the tool tip performing the current surgical procedure. According to some applications of the present invention, feedback is provided to assist the operator in performing robotic-assisted surgery. Feedback, typically provided by the control component unit 26 (as described in more detail below), typically assists the operator in maintaining the remote center of motion of the tool 21 by applying a force that opposes any movement of the joystick 30 and / or control component tool 32 that the operator attempts to make that deviates from the remote center of motion.

[0072] As mentioned above, in some applications, an operator provides commands to the robotic unit via the control component unit 26 (shown in FIG. 1 ). Typically, such commands include commands to control the position and / or orientation of a tool disposed in the robotic unit and / or commands to control an operation performed by the tool. In some applications, the robotic unit is configured to move the tool's entry into the patient's eye within the incision, and the computer processor is configured to drive the output unit to provide feedback to the operator indicative of the tool's entry position within the incision. For example, the computer processor may generate an output on one or more displays 24 indicative of the incision zone and the tool's entry position within the incision zone. In some applications, an output, such as a visual or audio alert, is generated when the tool is moved such that the tool's entry position within the patient's eye is within a given distance from the incision edge. In some applications, the computer processor is configured to drive the control component unit to provide feedback to the operator indicative of the tool's entry position within the incision. For example, as the tool is moved such that the tool entry position into the patient's eye is closer to the incision edge, the control component arm may increase resistance to movement and / or vibrate and / or generate a different output. It is noted that, according to some such applications of the present invention, the movement of the tool 21 itself is not constrained to maintain a remote center of motion and the tool may move freely. However, the control component provides force feedback (and / or other feedback) to the operator to assist the operator in moving the joystick 30 and control component tool 32 such that the tool 21 maintains a remote center of motion within the incision or within the incision zone. Some applications of the above-mentioned feedback are described in more detail below.

[0073] Reference is now made to Figures 3A and 3B, which are schematic illustrations of a tool 21 inserted through a patient's cornea 42, in accordance with some applications of the present invention. The tool tip 50 is moved as desired within the patient's eye while the tool entry position within the patient's eye is maintained within the incision. Figure 3A illustrates the insertion of an irrigation and aspiration tool 46 through the incision 40, and Figure 3B illustrates the insertion of a syringe 48. Typically, the robotic system 10 is configured to insert the tool 21 into the patient's eye such that the tool's entry into the patient's eye (i.e., the tool's remote center of motion position) is through the incision 40 and the tool tip 50 is located within the patient's eye. More typically, the robotic system is configured to assist the operator in moving the tool tip within the patient's eye such that the tool's entry into the patient's eye (i.e., the tool's remote center of motion position) remains within the incision. In some applications, the robotic system is configured to assist the operator by constraining the movement of the control component tool corresponding to how the movement of the ophthalmic tool should be constrained to prevent the tool's entry into the patient's eye from moving outside the incision. In some applications, the computer processor provides feedback to the operator to constrain the movement of the portion of the control component tool corresponding to the portion of the tool 21 that is currently within the incision (i.e., the tool's remote motion center position), while allowing the tip of the control component tool (corresponding to the tip of the tool 21) to move as desired. Typically, the control component tool is configured to provide feedback using one or more control component motors, as described in more detail below with reference to Figures 6A-6C.

[0074] In some applications, the computer processor identifies the tool currently positioned within the incision (i.e., what type of tool is currently positioned within the incision) and calculates the location of the remote center of motion of the ophthalmic tool relative to the incision based on the tool identified as currently positioned within the incision. For example, the computer processor identifies the tool currently positioned within the incision by analyzing an image captured using the imaging system 22 (e.g., using a machine vision algorithm). Alternatively or additionally, each tool can have a tool identification component (e.g., a marker, a bar code, and / or a QR code), and the computer processor identifies the tool currently positioned within the incision by identifying the tool identification component in the image captured using the imaging system 22. In some applications, the computer processor is configured to receive a manual input identifying which tool is currently positioned within the incision. As described above, the computer processor typically drives a control component unit to provide force feedback to the operator based on the location of the remote center of motion of the ophthalmic tool relative to the incision. 3B, in some applications, rather than constraining tool entry into the patient's eye to remain within the incision (which is typically only slightly larger than the maximum cross-sectional dimension of the tool penetrating the incision point), tool entry into the patient's eye is constrained to remain within a dissection zone 41 that is larger than the incision. In some applications, the area of ​​the dissection zone is greater than 150 percent or greater than 200 percent of the maximum cross-sectional dimension of the tool penetrating the dissection zone. For example, tool entry into the patient's eye may be greater than 2 mm 2 ~10mm 2 Alternatively, the robotic system may be configured to constrain tool entry into the patient's eye to remain within an incision that is just larger than the maximum cross-sectional dimension of the tool penetrating the incision, or to remain within an incision that is less than or equal to the maximum cross-sectional dimension of the tool penetrating the incision.

[0075] As mentioned above, typically the robotic system is configured to assist the operator in moving the tool 21 such that the tip of the tool is moved as desired within the patient's eye and the tool entry into the patient's eye is maintained within the incision zone. The longitudinal portion of the tool that is within the incision and serves as the remote center of motion is referred to herein as the "remote center of motion position of the tool." (Note that during the procedure, the position along the tool that is within the incision may change. The remote center of motion position of the tool represents any position along the tool that is currently within the incision.) In general, all descriptions of the robotic system assisting the operator in moving the tip of the tool within the patient's eye such that the remote center of motion position of the tool remains within the incision should be understood to mean assisting the operator in maintaining the remote center of motion position of the tool within the incision itself or within an incision zone that is a predetermined amount larger than the incision (e.g., as described in the previous paragraph). In some applications, a force is applied to the operator via the control component unit. This force varies as a function of the distance of the outer edge of the tool to the center of the incision.

[0076] In some applications, the control component unit is configured to apply a directional force that is calculated based on the configuration (i.e., position and orientation) and movement of the control component joystick 30 and / or the control component tool 32. For example, the computer processor can make a speed measurement of the movement of the control component tool and calculate a force to be applied to the control component arm simulating a physical interaction based on the speed measurement. Alternatively or additionally, the computer processor can make a measurement of the position of the ophthalmic tool relative to the incision and calculate a force to be applied to the control component arm simulating a physical interaction based on the position measurement. In some applications, the control component arm is configured to apply a torque to the user. In some applications, the feedback is configured to simulate a wall by applying a force to the operator whenever the operator attempts to move a portion of the control component tool 32 beyond a particular plane. In some such applications, the applied force is configured to be equal and opposite to the force applied by the operator to the control component tool 32 to give the sensation of a solid wall that the operator cannot overcome. Alternatively or additionally, the applied force is configured to be proportional to the distance from the center of the incision to the outer edge of the ophthalmic tool 21. Typically, this creates the sensation of a springy, bouncy obstacle that becomes more difficult to penetrate the deeper it is.

[0077] Referring again to FIG. 3A, by way of example only, the irrigation and aspiration tool 46 may be inserted through a 2.6 mm wide incision 40. The end of the irrigation and aspiration tool 46 has a well-defined longitudinal axis 52 that passes through the cross section. Typically, it is desirable to keep the longitudinal axis of the irrigation and aspiration tool 46 as close to the center of the incision 40 as possible. Assuming that the longitudinal axis of the irrigation and aspiration tool 46 passes through the center of the incision, if the operator moves the tool more than a given amount along the x-axis, incision widening may occur. Typically, tissue flexibility allows the outer edge of the tool to move beyond the edge of the incision without tearing the cornea. Thus, as discussed above, in some applications, the entry of the tool into the patient's eye is constrained to remain within a dissection zone 41 that is larger than the incision.

[0078] In some applications, based on the images of the tool and the patient's eye, and predetermined data regarding the tool dimensions, the computer processor is configured to determine the position and orientation of the remote center of motion of the tool relative to the incision. In some applications, the computer processor determines the position of the incision based on the position and orientation of the keratome blade when making the incision (and predetermined data regarding the width of the keratome blade), or by using computer vision, or by using a combination of the two. In some applications, the computer processor determines the position of the longitudinal axis of the tool relative to the incision (e.g., relative to the center of the incision, relative to the edge of the incision, and / or relative to the edge of the incision zone). For some tools, the longitudinal axis is linear and the cross-section of the tool is symmetrical about the axis. For some tools, the longitudinal axis of the tool is not linear, but varies at different positions along the length of the tool, and the longitudinal axis follows the center of gravity of the cross-section of the tool. In some applications, the computer processor determines the distance of the outer edge of the tool's remote center of motion location relative to the incision (e.g., relative to the center of the incision, relative to the edges of the incision, and / or relative to the edges of the incision zone). Typically, the computer processor determines the magnitude and / or direction of the feedback force provided to the operator based on the calculations described above.

[0079] In some applications, based on the above calculations, the computer processor calculates a force function that returns a force vector that the control component arm provides to the operator. The scope of the present disclosure includes providing any type of force function, some of which are described in detail with reference to Figs. 4A to 4I. In some applications, the force function is based on motion along the x-axis, motion along the y-axis, or both. The two-way force function is calculated as two independent functions or as one function with two inputs. In some applications (e.g., for a tool with a straight longitudinal axis and a constant cross-section), the force is not applied based on motion along the z-axis (i.e., back and forth through the incision, the z-axis being perpendicular to the x-axis and y-axis). This is because motion along the z-axis does not cause the tool to deviate from its remote center of motion position, which remains within the incision or incision zone. However, if the cross-section of the tool varies along its length, motion along the z-axis may provide feedback. This is because motion along the z-axis results in a change in the position of the outer edge of the tool cross-section relative to the incision or incision zone. Similarly, if the longitudinal axis of the tool is disposed at an angle to the z-axis, movement along the z-axis may generate feedback because movement along the z-axis results in a change in the position of the outer edge of the tool cross section relative to the cut or cut zone.

[0080] Reference is now made to Figures 4A, 4B, 4C, 4D, 4E, 4F, 4G, 4H, and 4I, which are graphs illustrating the variation in force applied to the control component arm as a function of the distance of the outer edge of the tool from the incision in the subject's cornea in accordance with each application example of the present invention.

[0081] With reference to Figure 4A, in some applications, a step function is applied. As an example, as described above with reference to Figure 3A, an irrigation and aspiration tool 46 can be inserted through a 2.6 mm wide incision 40. In this example, a step function can be applied in the x-direction, and the incision width is 2.6 mm.

[0082]

number

[0083] In this example, the force function is applied as a function of the distance of the longitudinal axis of the tool from the center of the incision at the tool's remote center of motion, but the scope of this disclosure includes calculating the force function as a function of other variables, such as the distance of the outer edge of the tool from the outer edge of the incision at the tool's remote center of motion. Additionally, the scope of this disclosure should not be interpreted by the specific distances and forces given in the examples above or below. These examples are provided to demonstrate the types of force functions that can be provided. The scope of this disclosure includes modifying these examples so that these types of force functions are applied using distances and forces different from those given.

[0084] Using function 1, if the operator moves the tool so that its axis is less than 1.3 mm from the incision center in any direction along the x-axis, no force is applied. If the operator moves the tool so that its axis is more than 1.3 mm from the incision center in any direction along the x-axis, a force of 10 N is applied. In this example, only the magnitude of the force is illustrated. The direction of the force is typically opposite to the direction of deviation, i.e., opposite to the sign of the distance. A more complete function is shown below.

[0085]

number

[0086] For simplicity, for all other functions described herein, the forces are displayed as magnitudes, however, it will be understood that the direction of the force is typically opposite to the direction of motion and directed toward the incision center.

[0087] The step function shown in FIG. 4A acts to create the sensation of two virtual walls at the edges of the incision. The operator feels no force being applied while the tool is within the incision, but if he attempts to move the tool axis more than 1.3 mm from the center of the incision he feels a force of 10 N (in this example) in the opposite direction to the operator's movement. Typically the force magnitude is made as large as the device will allow to simulate a solid wall. With such a force function, if the operator applies a force greater than 10 N (in this example), the tool edge of the tool will move out of the incision and the operator will feel a constant opposing force on the control component arm.

[0088] Other choices of force functions can be used to generate different sensations for the operator. One example is a linear function, shown graphically in FIG. 4B. In such a case, the further the operator moves the tool axis from the incision center (or the tool edge from the incision edge), the more force is applied trying to pull the tool back to the incision center. Such a function typically gives the operator a "springy" sensation, which can more accurately reflect the feeling of the tool being pressed against the edge of the incision than a step function. Furthermore, it allows the operator to push the tool beyond the edge of the incision while still giving the operator a clue as to how far beyond the edge of the incision the tool has been pushed.

[0089] In some applications, a combination of functions is provided. For example, as shown graphically in FIG. 4C, a linear function can be applied within a certain distance from the incision center, and when the distance from the center exceeds a certain amount (1 mm in the illustrated example), the linear function is applied. In this case, the operator typically feels no resistance within the incision, but as the incision edge is approached, a force is applied that varies linearly with distance from the incision center. This typically gives the operator some indication that the incision edge is being reached or has been reached. Similar to the function shown graphically in FIG. 4B, this function allows the operator to push the tool beyond the edge of the incision while giving the operator tactile cues that indicate how far beyond the edge of the incision the tool has been pushed.

[0090] In some applications, the parameters of the force function are configured to generate a given sensation. For example, for a linear force function, the feedback feel can be varied by changing the stiffness k using function 3 shown below:

[0091]

number

[0092] FIG. 4D graphically illustrates what a linear force function looks like with different stiffness values. Each line represents a different stiffness value. The lower the stiffness value, the less force is applied at a given distance from the incision center, and vice versa. In some applications, the robotic system allows the operator to select (e.g., by providing input to a computer processor) the force function and / or stiffness level they want to apply, and calculates the force to be applied to the operator based at least in part on the operator's selection. Some operators may prefer a high stiffness force function (to receive a clear indication that they have moved the tool toward or past the edge of the incision), while other operators may prefer a low stiffness force function (so that they are less resistant to force feedback).

[0093] In some applications, different combinations of force functions are used. For example, as shown graphically in FIG. 4E, (a) no force is applied when the longitudinal axis of the tool is within a first given distance range from the incision center (0-0.5 mm in the illustrated example), (b) a linear force function is applied when the axis of the tool is within a second given distance range from the incision center (0.5 mm-1.3 mm in the illustrated example), and (c) a stepped force function is applied when the axis of the tool is within a third given distance range from the incision center (1.3 mm or more in the illustrated example). In some applications, this combines the benefits of each type of function, allowing the operator (a) to not have to resist force feedback when close to the incision center, (b) to be given a gradual cue that indicates they are approaching the incision edge, and (c) to be given a "hard wall" sensation to prevent pushing the tool beyond the edge of the incision or incision zone.

[0094] In some applications, other types of force functions are applied, such as the exponential force function shown graphically in FIG.

[0095]

number

[0096] where a, b, and c are configurable parameters and e is the Euler number.

[0097] In some applications, such a function is configured to provide the operator with gradually increasing force feedback as the operator moves away from the center, creating a sensation of variable stiffness. Other functions, such as functions incorporating polynomials, logarithms, or powers, may also be used.

[0098] In some applications, additional combinations of functions are used, for example, a linear function (near the center of the incision) can be combined with an exponential function (away from the center of the incision), as shown graphically in FIG.

[0099] 4A-4G graphically illustrate a function that is applied based on displacement along the x-axis. In some applications, a similar function is applied for displacement along the y-axis. In some applications, the force to be applied is calculated separately based on displacement along the y-axis. Alternatively, a 2D force function is used based on displacement along both the x-axis and the y-axis.

[0100] By way of example only, FIGS. 4H and 4I graphically illustrate alternative representations of one example of a 2D exponential force function that may be applied in accordance with some applications of the present invention.

[0101] For example, function 5 proposed below can be used as the 2D force function.

[0102]

number

[0103] The force output can be interpreted as a vector or as a magnitude. When treated as a magnitude, the direction of the vector is typically toward the center of the incision.

[0104] Reference is now made to FIG. 5, which is a flow chart showing steps of a procedure according to some applications of the present invention. In a first step 60, the tool 21 is inserted into the incision 40 (the tool and incision are shown in FIGS. 3A-3B). In a second step 62, the force feedback function of the control component unit is activated. According to each application, the force feedback function of the control component unit is activated automatically (upon detection that the tool has been inserted into the incision) or manually by the operator. As mentioned above, in some applications, the operator selects the type and / or stiffness of the force function used for the feedback. The computer processor then detects whether the tool is still in the patient's eye (step 64). Assuming that the tool is still in the eye, the computer processor calculates the distance between the axis of the tool and the center of the incision at the remote center of motion position along the tool (step 66). (As discussed above, alternatively or additionally, the computer processor calculates the distance between the edge of the tool and the edge of the incision or incision zone at the remote center of motion position along the tool.) Based on step 66, the computer processor calculates the magnitude and direction of the force to be applied by the control component unit to the operator (step 68). In step 70, the force calculated in step 68 is applied. Assuming that in step 64 it is detected that the tool is no longer within the eye, the force feedback is terminated (step 72). Depending on the application, the force feedback function of the control component unit is either terminated automatically (in response to detection that the tool has been removed from the incision) or manually by the operator.

[0105] Reference is now made to Figures 6A, 6B, and 6C, which are schematic diagrams of the joystick 30 and control component tool 32 of the control component unit 26 according to some applications of the present invention. As shown in Figures 6A, 6B, and 6C, in some applications, the joystick 30 is configured as a control component arm including two or more links 80A, 80B, 80C connected by rotating arm joints 82A, 82B, 82C. The terms "joystick" and "control component arm" are used interchangeably in this disclosure. In some applications, each motor 84A, 84B, 84C is configured to control the movement of each of the rotating arm joints to provide feedback to the operator. Typically, the feedback is effective to make a location 86 on the control component tool 32 feel like the center of motion of the control component tool, such that movement of this location in a given direction provides a feedback force to the operator. Typically, the strength and direction of the feedback force are according to one of the examples described above. More typically, the overall force vector is composed of forces in the x, y, and z directions of the control component tool (as shown in FIG. 6A), which do not necessarily correspond directly to the x, y, and z directions of the ophthalmic tool 21 (as described above).

[0106] With reference to Figures 6B and 6C, it should be noted that typically the majority of the motors (e.g. at least two of the motors (motors 84B and 84C)) provide torque directly to the rotating arm joints without the need for gears or belts to transmit force, i.e. they are direct drive motors. In some applications, at least one of the motors (84A) provides torque to one of the rotating arm joints (82A) via a belt 88. The use of a belt typically allows the motors to be positioned closer to the base 90 of the control component unit (base 90 shown in Figure 7). The purpose is to reduce the weight and inertia felt by the operator compared to if a third motor was located closer to the rotating arm joint 82A.

[0107] However, it may be preferable to use more control component motors so that the feedback provided to the operator by the joystick more fully reflects the remote center of motion position of the ophthalmic tool relative to the incision. For example, in some applications, six motors are used such that the control components are configured to provide 3D force vectors and 3D torque vectors. The scope of the present disclosure includes the use of one to six motors to provide feedback to the operator via the control components. However, the use of four or more motors typically adds additional weight and complexity to the joystick design. Furthermore, the inventors have found that the use of three motors provides useful feedback to the operator that more fully reflects the remote center of motion position of the ophthalmic tool relative to the incision. Thus, as shown in Figures 6A and 6B, each joystick typically includes three motors.

[0108] Reference is now made to FIG. 7, which is a schematic diagram of some additional components of the control component unit 26 according to some applications of the present invention. Typically, in addition to the motors mentioned above, each control component arm includes a rotary encoder 92 coupled to each of the three rotary arm joints 82A, 82B, 82C (e.g., as described in U.S. Patent Application 17 / 818,477, a continuation of Glozman's WO 22-023962, which is incorporated herein by reference). The rotary encoder is configured to detect movement of each rotary arm joint and generate rotary encoder data in response. In some applications, the control component arm further includes an inertial measurement unit 94 including a three-axis accelerometer, a three-axis gyroscope, and / or a three-axis magnetometer. The rotary encoder and the inertial measurement unit are collectively referred to herein as "position sensors." The inertial measurement unit typically generates inertial measurement unit data related to the three-dimensional orientation of the control component arm in response to movement of the control component arm. In some applications, the computer processor 28 receives the rotary encoder data and the inertial measurement unit data. Typically, the computer processor determines the XYZ position of the tip of the control component tool 32 based on the rotary encoder data, and determines the orientation (e.g., three Euler angles of orientation and / or another representation of orientation) of the tip of the control component tool 32 based on the inertial measurement unit data, or based on a combination of the rotary encoder data and the inertial measurement unit data. Thus, based on a combination of the rotary encoder data and the inertial measurement unit data, the computer processor is configured to determine the XYZ position and orientation of the tip of the control component tool.

[0109] In some applications, the computer processor drives the robotic unit such that the tip of the ophthalmic tool being used to perform the procedure tracks the movement of the tip of the control component tool. In some applications, the computer processor drives the robotic unit such that the tip of the ophthalmic tool being used to perform the procedure tracks the movement of the tip of the control component tool in six degrees of freedom. Typically, incorporating an inertial measurement unit to detect the three-dimensional orientation of the control component arm allows an operator to control the movement of the robotic unit using fewer sensors than if a rotational encoder were used to detect the movement of the control component arm in all six degrees of freedom. Furthermore, typically, using fewer rotational encoders tends to reduce the overall complexity of the control component arm, since the introduction of additional rotational encoders requires additional wires to be threaded through the rotating joints.

[0110] Despite the complexity associated with additional rotary encoders, in some applications the control component arm includes four or more rotary encoders in addition to the inertial measurement unit. This is for redundancy, i.e., to allow the system to use the additional position sensors if some of the position sensors fail. In some such applications the control component arm includes additional rotary encoders at each rotary arm joint for redundancy. Further, in some applications the control component includes rotary encoders for redundancy in addition to the inertial measurement unit to detect the roll, pitch, and yaw of the tool 32 of the control component tool. In some such applications the tool 32 is coupled to the control component arm via three rotary tool joints corresponding to the roll, pitch, and yaw of the tool 32. Typically, the above mentioned rotary encoders detect the movement of each rotary tool joint at which the control component tool is coupled to the control component arm.

[0111] Although some applications of the present invention are described for cataract surgery, the scope of this application includes the mutatis mutandis application of the devices and methods described herein to other medical procedures. In particular, the devices and methods described herein for other medical procedures may be applied to other microsurgical procedures such as general surgery, orthopedic surgery, gynecology, otorhinolaryngology, neurosurgery, oral and maxillofacial surgery, plastic surgery, podiatry surgery, vascular surgery, and / or pediatric surgery performed using microsurgical techniques. In some such applications, the imaging system includes one or more microscopic imaging units.

[0112] It should be noted that the scope of this application includes the mutatis mutandis application of the devices and methods described herein to intraocular procedures other than cataract surgery, which may include collagen cross-linking, endothelial keratoplasty (e.g., DSEK, DMEK, and / or PDEK), DSO (Descemet's membrane stripping without grafts), laser-assisted corneal transplantation, corneal transplantation, LASIK / PRK, SMILE, pterygium, ocular surface cancer treatment, secondary IOL placement (suture, transconjunctival, etc.), iris repair, IOL repositioning, IOL exchange, keratomileusis, minimally invasive glaucoma surgery (MIGS), limbal stem cell transplantation, astigmatic keratotomy, limbal relaxing incision (LRI), amniotic membrane transplantation (AMT), glaucoma surgery (e.g., trABs, tuBes, minimally invasive glaucoma surgery), automated lamellar keratoplasty (ALK), anterior vitrectomy, and / or pars plana anterior vitrectomy.

[0113] Applications of the invention described herein may take the form of a computer program product accessible from a computer usable or computer readable medium (e.g., a non-transitory computer readable medium) that provides program code for use by or in connection with a computer or any instruction execution system, such as computer processor 28. For purposes of this description, a computer usable or computer readable medium may be any apparatus that can contain, store, transmit, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. The medium may be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or propagation medium. Typically, the computer usable or computer readable medium is a non-transitory computer usable or computer readable medium.

[0114] Examples of computer-readable media include semiconductor or solid state memory, magnetic tape, removable computer diskettes, random access memory (RAM), read-only memory (ROM), rigid magnetic disks, and optical disks. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read / write (CD-R / W), DVDs, and USB drives.

[0115] A data processing system suitable for storing and / or executing program code will include at least one processor (e.g., computer processor 28) coupled directly or indirectly to memory elements via a system bus. The memory elements may include local memory used during the actual execution of the program code, bulk storage, and cache memory for temporary storage of at least some of the program code to reduce the number of times the code must be retrieved from bulk storage during execution. The system is capable of reading instructions according to the present invention on a program storage device and performing the method of the present invention according to these instructions.

[0116] Network adapters may be coupled to a processor to enable the processor to be coupled to other processors, remote printers, or storage devices through intervening private or public networks. Modems, cable modems, and Ethernet cards are just a few of the types of network adapters currently available.

[0117] Computer program code for carrying out operations of the present invention may be written in any combination of one or more programming languages, including object-oriented programming languages, such as JAvA, SMAlltAlk, C++, and conventional procedural programming languages, such as the C programming language or a similar programming language.

[0118] It will be understood that the algorithms described herein may be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine whereby the instructions executed by the processor of the computer (e.g., computer processor 28) or other programmable data processing apparatus produce means for performing the functions / actions specified in the algorithms described herein. These computer program instructions may also be stored on a computer readable medium (e.g., a non-transitory computer readable medium) and may direct a computer or other programmable data processing apparatus to function in a particular manner, whereby the instructions stored on the computer readable medium produce an article of manufacture including instruction means for performing the functions / actions specified in the algorithms. The computer program instructions may also be loaded into a computer or other programmable data processing apparatus to cause the computer or other programmable apparatus to perform a series of operational steps to produce a computer implemented process whereby the instructions executing on the computer or other programmable apparatus provide a process for performing the functions / actions specified in the algorithms described herein.

[0119] The computer processor 28 is typically a hardware device that is programmed with computer program instructions to create a special purpose computer. For example, when programmed to execute the algorithms described with reference to the figures, the computer processor 28 typically functions as a special purpose robotics system computer processor. Typically, the operations described herein performed by the computer processor 28 change the physical state of a memory, which is an actual physical item, resulting in a different magnetic polarity, charge, etc., depending on the memory technology used. In some applications, the operations described as being performed by a computer processor are performed by multiple computer processors that are coupled together.

[0120] It will be understood by those skilled in the art that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention includes both combinations and subcombinations of the various features described in the foregoing specification, as well as variations and modifications thereof that are not in the prior art and that would occur to those skilled in the art upon reading the foregoing description.

Claims

1. 1. An apparatus for performing a procedure on a patient's eye with an ophthalmic tool having a distal tip, comprising: a robotic unit configured to move the ophthalmic tool; A control component unit, a control component tool configured to be moved by an operator and defining a tip; at least one control component arm coupled to the control component tool and including one or more position sensors; a control component unit comprising:

1. A computer processor comprising: driving the robotic unit to insert the ophthalmic tool into the patient's eye through a corneal incision of the patient's eye such that a tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion of the ophthalmic tool is positioned within the incision; determining a position and orientation of the tip of the control component tool based on data received from the one or more position sensors; moving the tip of the ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; providing feedback to the operator indicative of placement of the remote center of motion position of the ophthalmic tool relative to the incision; a computer processor configured to: An apparatus comprising:

2. The control component arm comprises a plurality of links interconnected via rotary arm joints, and the one or more position sensors include: three rotary encoders, each coupled to a respective one of the rotary arm joints, configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; The apparatus of claim 1 , comprising:

3. the control component arm comprises a plurality of links interconnected via rotary arm joints, the control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; The apparatus of claim 1 , comprising:

4. 4. The apparatus of claim 1, wherein the computer processor is configured to provide feedback to the operator indicating the placement of the remote center of motion position of the ophthalmic tool relative to the incision by generating an alert when the ophthalmic tool is moved so that the remote center of motion position of the ophthalmic tool is within a given distance from an edge of the incision.

5. 4. The apparatus of claim 1, wherein the computer processor is configured to provide feedback to the operator indicative of the placement of the remote center of motion position of the ophthalmic tool relative to the incision by providing force feedback to the operator via the control component arm.

6. The computer processor determining the identity of the ophthalmic tool inserted into the patient's eye; calculating a location of the remote center of motion position of the ophthalmic tool relative to the incision based on the identity of the ophthalmic tool; The device according to claim 5, configured to:

7. The computer processor performing a velocity measurement of the control component tool; calculating a force applied to the operator based on the velocity measurements; Actuating the control component to apply the calculated force to the operator.

6. The apparatus of claim 5, configured to provide force feedback to the operator via the control component by:

8. The computer processor obtaining a measurement of the position of the ophthalmic tool relative to the incision; calculating a force applied to the operator based on the position measurements; Driving the control component arm to apply the calculated force to the operator.

6. The apparatus of claim 5, configured to provide force feedback to the operator via the control component arm by:

9. 6. The apparatus of claim 5, wherein the computer processor is configured to calculate the force applied to the operator by calculating a force that is equal and opposite to the force applied by the operator to the control component tool.

10. 6. The apparatus of claim 5, wherein the computer processor is configured to calculate the force applied by the operator by calculating a force proportional to the distance from the center of the incision to the outer edge of the ophthalmic tool.

11. 6. The apparatus of claim 5, wherein the computer processor is configured to receive input from the operator indicating a stiffness of force feedback the operator desires to receive, and to calculate a force to be applied to the operator based at least in part on the input from the operator.

12. The apparatus of claim 5 , wherein the computer processor is configured to constrain movement of the control component tool to correspond to how movement of the remote center of motion position of the ophthalmic tool relative to the incision should be constrained.

13. The apparatus of claim 12 , wherein the computer processor is configured to constrain movement of the control component tool to constrain the remote center of motion position of the ophthalmic tool to remain within an incision zone larger than the incision.

14. The apparatus of claim 12 , wherein the computer processor is configured to constrain movement of the control component tool to constrain the remote center of motion position of the ophthalmic tool to remain within the incision.

15. 6. The apparatus of claim 5, wherein the computer processor is configured to calculate the force applied by the operator by calculating a force function based on the distance of an outer edge of the ophthalmic tool in two directions from the center of the incision.

16. 16. The device of claim 15, wherein a first of the two directions is parallel to the incision and tangent to the cornea of ​​the patient's eye at the incision, and a second of the two directions is perpendicular to the first direction and tangent to the cornea of ​​the patient's eye at the incision.

17. the control component arm comprises a plurality of links interconnected via rotating arm joints and one or more motors operably coupled to each rotating arm joint; 4. The apparatus of claim 1, wherein the computer processor is configured to provide force feedback to the operator by driving the control component arm with the plurality of motors.

18. 20. The apparatus of claim 17, wherein the control component arm comprises three motors operably coupled to each joint.

19. 20. The apparatus of claim 17, wherein the control component arm includes a belt and at least one of the motors is operably coupled to a corresponding one of the rotating arm joints via the belt such that the at least one of the motors is positioned closer to a base of the control component unit than if the at least one of the motors directly drove the corresponding one of the rotating arm joints.

20. 18. The apparatus of claim 17, wherein a majority of the one or more motors directly drive a corresponding one of the rotating arm joints to which they are operatively coupled.

21. The one or more position sensors three rotary encoders, each coupled to a respective one of the rotary arm joints, configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; 20. The apparatus of claim 17, comprising:

22. The control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; 20. The apparatus of claim 17, comprising:

23. 1. An apparatus for performing a procedure on a patient's eye with an ophthalmic tool having a distal tip, comprising: a robotic unit configured to move the tool; A control component unit, a control component tool configured to be moved by an operator and defining a tip; a control component arm coupled to the control component tool, a plurality of links interconnected via rotary arm joints; one or more position sensors; one or more motors operably coupled to each rotating arm joint; a control component arm comprising: a control component unit comprising:

1. A computer processor comprising: driving the robotic unit to insert the ophthalmic tool into the patient's eye through the corneal incision of the patient's eye so that a tip of the ophthalmic tool is positioned within the patient's eye; determining a position and orientation of the tip of the control component tool based on data received from the one or more position sensors; moving the tip of the selected ophthalmic tool within the patient's eye to correspond with the movement of the control component tool; providing force feedback to the operator by driving the control component arm using the plurality of motors; a computer processor configured to: An apparatus comprising:

24. 24. The apparatus of claim 23, wherein the control component comprises three motors operatively coupled to each rotating arm joint.

25. 24. The apparatus of claim 23, wherein the control component arm includes a belt and at least one of the motors is operably coupled to a corresponding one of the rotating arm joints via the belt such that the at least one of the motors is positioned closer to a base of the control component unit than if the at least one of the motors directly drove the corresponding one of the rotating arm joints.

26. 24. The apparatus of claim 23, wherein a majority of the one or more motors directly drive a corresponding one of the rotating arm joints to which they are operatively coupled.

27. The one or more position sensors three rotary encoders, each coupled to a respective one of the rotary arm joints, configured to detect movement of the respective rotary arm joint and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; 24. The apparatus of claim 23, comprising:

28. The control component tool is coupled to the control component arm via three rotary tool joints, and the one or more position sensors are two rotary encoders coupled to respective ones of the rotary arm joints and configured to detect movement of the rotary arm joints and responsively generate rotary encoder data indicative of the XYZ position of the tip of the control component tool; a rotary encoder coupled to each one of the rotary tool joints and configured to detect movement of the rotary tool joint and responsively generate rotary encoder data indicative of an orientation of the tip of the control component tool; an inertial measurement unit including at least one sensor selected from the group consisting of a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer, the inertial measurement unit configured to generate inertial measurement unit data indicative of an orientation of the tip of the control component tool; 24. The apparatus of claim 23, comprising:

29. The computer processor driving the robotic unit to insert the ophthalmic tool into the patient's eye through the incision in the cornea of ​​the patient's eye so that the tip of the ophthalmic tool is positioned within the patient's eye and a remote center of motion of the ophthalmic tool is positioned within the incision; providing force feedback to the operator indicative of the placement of the remote center of motion of the ophthalmic tool relative to the incision; 29. An apparatus according to any one of claims 23 to 28, configured to:

30. The computer processor determining the identity of the ophthalmic tool inserted into the patient's eye; calculating a location of the remote center of motion position of the ophthalmic tool relative to the incision based on the identity of the ophthalmic tool; 30. The apparatus of claim 29, configured to:

Images