ROBOT MANIPULATOR FOR EYE SURGERY TOOL

An eye surgery apparatus includes an eye surgery tool, an imaging system, a robotic arm, and a processor. The eye surgery tool has a distal end for insertion into an eye of a patient through an incision in the eye. The imaging system is configured to acquire images showing the incision and at least part of the eye surgery tool. The robotic arm is coupled with the eye surgery tool, which is configured to move the distal end of the eye surgery tool inside the eye according to one or more commands issued during an eye surgery. The processor is configured to, during the eye surgery (i) receive the images from the imaging system, (ii) monitor the commands issued to the robotic arm, (iii) detect, by analyzing the images, that a monitored command is expected to enlarge the incision, and (iv) initiate responsive action with respect to the detected command.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to robotic medical systems for eye surgery, and particularly to robotic phacoemulsification systems.

BACKGROUND OF THE DISCLOSURE

An eye surgery may be required in some ophthalmic medical conditions. For example, a physician may recommend cataract removal using phacoemulsification cataract surgery. In the procedure, the surgeon makes a small incision in the sclera or cornea of the eye. Then a portion of the anterior surface of the lens capsule is removed to gain access to the cataract. The surgeon then uses a phacoemulsification probe, which has an ultrasonic handpiece with a needle. The tip of the needle vibrates at ultrasonic frequency to sculpt and emulsify the cataract while a pump aspirates particles and fluid from the eye through the tip. Aspirated fluids are replaced with irrigation of a balanced salt solution to maintain the anterior chamber of the eye. After removing the cataract with phacoemulsification, the softer outer lens cortex is removed with suction. An intraocular lens (IOL) is then introduced into the empty lens capsule restoring the patient's vision.

Various techniques to invasively treat a cataracted eye were proposed in the patent literature. For example, U.S. Pat. No. 10,744,035 describes systems and processes for facilitating the removal of cataract material with a robotically assisted tool with laser, irrigation capabilities, aspiration capabilities. Tool guidance systems that make use of vision technologies, including optical coherence tomography (OCT), white light imaging, and structured light imaging. Emulsification patterns optimized to minimize risk to the patient and reduce procedure time. Robotic tools with articulation capabilities that allow for precise control during capsulorhexis and emulsification procedures. Robotic instrument drive mechanisms combined with pumps, flow meters, and valves regulate and control irrigation and aspiration functionalities during robotic ophthalmologic procedures. Use of a robotically controlled articulating tip may minimize the size of the incision in the lens capsule necessary to extract the cataract material.

DETAILED DESCRIPTION OF EXAMPLES

Overview

Eye surgery may involve inserting a number of surgical tools into the eye via small incisions made in the surface of the eye. For example, cataract surgery typically requires two incisions in the cornea: one for a phacoemulsification probe, and a second for a different tool such as a curette. The surgeon performing the procedure adjusts movements of the inserted tools in such a way so as not to enlarge the incisions. However, if the tools are operated robotically, there may be no such limitation placed on the robots.

Examples of the present disclosure that are described hereinafter provide a robotic eye surgery apparatus and algorithms to perform eye surgery using tools held by robotic arms of the apparatus while maintaining minimal and stable incision entry points during the procedure.

In some examples, the processor identifies the position of the eye surgery tool relative to the incision, by analyzing images acquired in real-time. Based on the identified position, the processor detects that the command is expected to enlarge the incision. To this end, the coordinates of any incision are identified by image processing (e.g., using edge detection) and the processor can determine if a requested track of the tip (given in a same coordinate system) will comprise the incision.

Typically, a processor of the apparatus instructs the robots to move the distal tips in response to commands the processor receives from a surgeon performing the surgery, which the processor finds will not increase the incision. The command can be alternatively received from a robot that performs the surgery automatically using a suitable algorithm, and in such a case the processor verifies the robot automatic operation does not increase the incision. Alternatively, a treatment plan (e.g., an order of removal of a cataract) is uploaded to the processor so it moves the distal tips (e.g., tips of rigid distal ends) so the distal tips cover a volume of the lens according to the plan. The processor overrides any step in the treatment plan that may increase the incision. For both robotic methods, the means described below ensure that the distal end motions do not cause unwanted enlargement of the incisions.

In one example, two robotic arms, one for the phacoemulsification probe, the other for a second tool, are controlled by the processor, which also controls an imaging system. The imaging system images the incisions made in the eye and the distal tips of the phacoemulsification probe and the tool inside the eye. From the images, the processor determines the locations of the incisions and the distal tips. The processor uses this information to calculate robotic motion of the distal ends (that can be fully rigid, or sufficiently rigid relative to eye tissue) that is safe to tissue near the incision, as further described below.

In an example, before performing any given movement, for example moving the distal tip of the phacoemulsification probe several millimeters in a direction to emulsify the lens, the processor calculates how the requested movement can be made so that the only motion of the phacoemulsification probe at the incision is rotation around the incision, using the incision as a pivot point of the rigid distal end, and/or translation of the distal end into or out of the incision. These types of movements do not enlarge the incision, and so the processor calculates and commands the robotic arm (that has a sufficient number of degrees of freedom) to make only these types of movements.

In another example, the processor overrides any command made by a surgeon that is predicted by the processor calculations to enlarge an incision. Namely, no movement of the rigid distal ends which might enlarge an incision is permitted. In another example, if the surgeon further requests such a movement, the processor warns the surgeon that the request may enlarge the incision.

Using the disclosed apparatuses and methods for robotic eye surgery (e.g., emulsification) may allow more accurate and less hazardous eye surgeries, such as cataract surgeries.

APPARATUS DESCRIPTION

FIG.1is a schematic, pictorial view of an eye surgery apparatus10comprising robot-mounted eye surgical tools12and13, in accordance with an example of the present disclosure. Surgical tools12and13are mounted on robot arms44and66, respectively, and have rigid distal ends14and17, respectively, engaging a lens capsule18of an eye20of a patient19. The rigid distal ends are inserted via respective incisions8and9in the cornea of eye20, the incisions made just before by another tool, e.g., by a physician11.

In the example shown in inset25, rigid distal end14comprises, by way of example, phacoemulsification probe12, which itself comprises an aspiration channel15and an irrigation channel16(which can be coaxial or side-by-side). As shown, aspiration channel15has an inlet115, and irrigation channel16has an outlet116, both at a distal tip of phacoemulsification probe12, from which cataract fragments are aspirated and into which replenishing irrigation fluid flows, respectively. Rigid distal end14is shown straight, though it may be curved or bent. Rigid distal end17is of another surgical tool (13), for example a curette.

Robotic arms44and66(mounted on a base102) are configured to, at minimum, tilt directions of respective distal ends14and17within lens capsule18, and adjust a depth of the distal ends inside the eye, while maintaining axes, or pivots, of distal ends14and17at respective incisions8and9in eye20, so as not to enlarge incisions8and9, as described inFIG.2. While the shown example uses robotic arms44and66, each having six degrees of freedom, the number of degrees of freedom may vary with design, to maintain the aforementioned axes at incisions8and9while the distal tips of rigid distal ends14and17move inside eye20.

In the exemplified example, during the phacoemulsification procedure robotic arm44moves rigid distal end14so that aspiration inlet115and irrigation outlet116follow a path (shown inFIG.2) inside the eye, according to, for example, commands from a processor38communicated via a cable31, that implements a treatment plan (e.g., one stored in a memory35) made by physician11. Similarly, robotic arm66moves rigid distal end17according to commands from processor38communicated via a cable33, typically in a coordinated track with that of rigid distal end17.

In the shown example, console28comprises a piezoelectric drive module30, which is coupled, using electrical wiring running in cable37, with a piezoelectric crystal inside probe12that generates vibration of rigid distal end14that breaks cataracted lens18. Drive module30is controlled by processor38to adjust a vibration power and/or duration and/or frequency.

During the phacoemulsification procedure, a pumping subsystem24comprised in a console28pumps irrigation fluid from an irrigation reservoir to outlet116to irrigate the eye. In an example, the irrigation fluid may be administered via a gravity-fed method or any other known method in the art. The fluid is pumped via a tubing line43running from the console28to phacoemulsification probe12. Eye fluid and waste matter (e.g., emulsified parts of the cataract) are aspirated via inlet115to a collection receptacle (not shown) by a pumping subsystem26also comprised in console28and using a tubing line46running from phacoemulsification probe12to console28.

In the shown example, apparatus10further comprises an eye imaging system58mounted on base102, e.g., a video camera with an optical imaging axis155, the camera capturing an image (e.g., records video images) of the aforementioned incisions8and9, and of lens capsule18, both in real time, including the inserted rigid distal ends. The captured image69is displayed on a display36. Real time image processing enables processor38to calculate the required motions of robotic arms44and66, so as to perform the eye surgery without enlarging eye incisions8and9, or to override surgeon's11commands that may cause enlargement of an incision, as described below.

Processor38presents other results of the cataract removal procedure on display36. Processor38may receive user-based commands via a user interface40, which may include setting or adjusting an irrigation rate and/or aspiration rate. User interface40may be combined with a touch screen graphical user interface of display36.

Some or all of the functions of processor38may be combined in a single physical component or, alternatively, implemented using multiple physical components. These physical components may comprise hard-wired or programmable devices, or a combination of the two. In some examples, at least some of the functions of processor38may be carried out by suitable software stored in memory35(as shown inFIG.1). This software may be downloaded to a device in electronic form, over a network, for example. Alternatively, or additionally, the software may be stored in tangible, non-transitory computer-readable storage media, such as optical, magnetic, or electronic memory.

The apparatus shown inFIG.1may include further elements, which are omitted for clarity of presentation. For example, physician11may hold a control handle with which the physician can, for example, abort the automatic procedure. Physician11may apply medications with another tool, which is also not shown in order to maintain clarity and simplicity of presentation.

While the exemplified surgical procedure involves corneal incisions, incisions may be performed at other eye locations, depending on the type of eye surgery. Enlarging incisions in such other locations (e.g., at the sclera) would similarly need to be minimized during the surgery, to prevent damage to the eye. WhileFIG.1refers to eye surgical tools, the technique can also be used with eye diagnostic devices (e.g., a miniature camera, illuminator, pressure and/or temperature sensors, among others) fitted at a distal portion of a rigid distal end for insertion into the eye.

Robot Manipulators for Eye Tools

FIG.2is a block diagram schematically illustrating the operation of apparatus10ofFIG.1using incision8as a pivot point for phacoemulsification probe12, in accordance with an example of the present disclosure.

As seen, rigid distal ends14and17of respective probe12and tool13are located partially inside eye20, accessing the eye via incisions8and9. Probe12and tool13are coupled to respective robotic arms44and66to perform an operation inside lens capsule18, such as phacoemulsification (using probe12) and curetting (using tool13). To this end, by way of example, a distal portion111of distal rigid end14is inside the eye, with portion111length measured between a pivot point250at incision8and a tip112of rigid distal end14.

Assuming tip112is required to follow a path222, processor38calculates the movement required by robotic arm44and instructs the robotic arm to move tip112along path222by changing only a pivot angle114and length of distal portion111within the eye. In this way, incision8is not enlarged by the required motion. As illustrated by layout212, the robotic arm moves the probe (now designated 12′) to a new position and orientation such that rigid distal end14goes through the same pivot point250to a new location over path222(i.e., by having a different angle and portion length).

Processor38calculates the required motion using information from imaging system58that can be a video camera with an optical imaging axis155and field of view (FOV)255. A video camera of imaging system58captures at least part of the eye, including incisions8and9and the distal tips (e.g., tip112) of the phacoemulsification probe and the curetting tool, and from these images the processor determines if and how to move the distal tips.

The example apparatus shown inFIG.2is chosen purely for the sake of conceptual clarity. For example, the rigid distal ends may be curved or bent. As another example, imaging system58may include built-in image processing circuitries to perform the required image processing.

FIG.3is a flow chart schematically illustrating an incision pivot point operating method of apparatus10ofFIG.1, in accordance with an example of the present disclosure. The algorithm, according to the presented example, carries out a process that begins with physician11operating apparatus10(e.g., processor38) to command robotic arm44to have a surgical tool, such as diamond tipped knife perform the incision (e.g., incision8) in eye20, at an eye incision step302. Alternatively, the incision may be performed manually by physician11, using, for example, a scalpel or another type of blade.

At a distal end insertion step304, processor38commands robotic arm44to have tool12insert a distal portion111of rigid distal end14through incision6into a predetermined location inside eye20.

Processor38receives the images and perform image processing to determine coordinates of incision8and tip112of rigid distal end14inside eye20, at an image processing step308.

The processor receives a command from surgeon11at a command receiving step309, to move rigid distal end14inside eye20to, for example, perform phacoemulsification at a new location in lens18.

Processor38monitors the commands issued by the surgeon to the robotic arm, to check if a monitored command is expected to enlarge the incision. To this end, processor38analyzes the images processed in step308. Using the coordinates determined in step308, processor38calculates the required motion of rigid distal end14and checks if the motion will enlarge incision8, at a checking step310.

If the answer is yes, processor38initiates a responsive action with respect to the monitored and detected potentially hazardous tip moving command, e.g., responsive action such as overriding the command and providing an audio and/or visual warning to physician11, at a command overriding step312.

In some examples, the processor is configured to block the detected command from being executed by the robotic arm and/or to output an alert to the surgeon with respect to the detected command.

If the answer is no, processor38instructs robotic arm44to move rigid distal end14inside eye20over a path as required by the commanded step (e.g., to follow track222) while maintaining incision8as a pivot point of the motion of the distal end, at tool operation step314.

The example flow chart shown inFIG.3is chosen purely for the sake of conceptual clarity. For example, as described above, additional tools may be inserted via different incisions in the eye.

An eye surgery apparatus (10), comprising (a) an eye surgery tool (12,13) having a distal end (14,17) for insertion into an eye (20) of a patient (19) through an incision (8,9) in the eye, (b) an imaging system (58), which is configured to acquire images (69) showing the incision (8,9) and at least part of the eye surgery tool (12,13), (c) a robotic arm (44,66) coupled with the eye surgery tool (12,13), which is configured to move the distal end (14,17) of the eye surgery tool (12,13) inside the eye (20) according to one or more commands issued during an eye surgery, and (d) a processor (38), which is configured to, during the eye surgery (i) receive the images (69) from the imaging system (58), (ii) monitor the commands issued to the robotic arm (44,66), (iii) detect, by analyzing the images (69), that a monitored command is expected to enlarge the incision (8,9), and (iv) initiate a responsive action with respect to the detected command.

The eye surgery apparatus according to example 1, wherein the one or more commands are issued by one of a surgeon and an algorithm that the robotic arm (44,66) executes.

The eye surgery apparatus according to example 1 or 2, wherein the processor (38) is configured to identify a position of the at least part of the eye surgery tool (12,13), relative to the incision (8,9), by analyzing the images (69), and to detect, based on the identified position, that the command is expected to enlarge the incision (8,9).

The eye surgery apparatus according to example 1 or 2, wherein the processor (38) is configured to block the detected command from being executed by the robotic arm (44,66).

The eye surgery apparatus according to example 1 or 2, wherein the processor (38) is configured to output an alert to a surgeon with respect to the detected command.

The eye surgery apparatus according to any one of examples 1-5, wherein the eye surgery is a phacoemulsification procedure, the eye surgery tool is a phacoemulsification probe (12), and the imaging system (58) is configured to image a tip (112) of the phacoemulsification probe (12).

The eye surgery apparatus according to any one of examples 1-7, wherein the imaging system (58) comprises a video camera, and wherein the images (69) comprise video images.

An eye surgery method, comprising (a) inserting a distal end of an eye surgery tool into an eye of a patient through an incision in the eye, (b) using an imaging system, acquiring images showing the incision and at least part of the eye surgery tool, (c) using a robotic arm, moving the distal end of the eye surgery tool inside the eye according to one or more commands issued to the robotic arm, (d) receiving the images from the imaging system, (e) monitoring the commands issued to the robotic arm, (f) detecting, by analyzing the images, that a monitored command is expected to enlarge the incision, and (g) initiating a responsive action with respect to the detected command.

Although the examples described herein mainly address eye surgeries, and cataract surgeries in particular, the methods described herein can also be used in other minimally invasive surgical applications at other body locations (e.g., via skin or skull) using rigid tools having access via small incisions that require protection from enlargement.