The present invention relates to the general technical field of the treatment of ocular pathologies by using therapy equipment intended to perform operations on the eye, and more particularly:
More specifically, the invention relates to a device and a method for monitoring the movement of an ocular pathology treatment system mounted on an articulated robotic arm to allow its movement along three orthogonal axes X, Y and Z.
In general, the present invention finds an application, when a therapy equipment will act in the eye on the surface or in depth by means of physical agents (such as light waves, ultrasounds, microwaves, etc.), whose path must be accurately controlled, in order to reach the target without damaging the adjacent structures.
In the following, the invention will be described with reference to therapy equipment including an articulated robotic arm integrating a system for cutting a human or animal tissue, such as a cornea, or a crystalline lens, by means of a femtosecond laser.
It is however very obvious to those skilled in the art that the invention described below can be used for the monitoring of the movement of an articulated robotic arm integrating any other type of system for treating an ocular pathology.
There are many therapy equipment items including a laser for the treatment of ocular pathology. The laser is then used as an optical scalpel.
Such a laser is capable of making incisions on the transparent tissues of the eye, in depth, without using surgical instruments. It has the advantage of being quick and well tolerated, but above all of eliminating the manual surgical procedure which is operator-dependent.
Thus, the surgery performed with a laser becomes extremely accurate and repeatable. It provides a guarantee of safety which cannot be achieved with a gesture performed by a human operator, so that the use of a laser allows considering a quasi-automated surgery, where the machine will carry out steps of the surgical procedure instead of the practitioner.
In order for therapy equipment including a laser to carry out steps of a treatment procedure, two essential phases must be implemented beforehand:
To carry out step i), it is necessary to position on the patient's eye an immobilization member equipped with a suction ring capable of suctioning the eye and holding it firmly in position.
At present, the therapy equipment acting in the eye and requiring immobilization of the eyeball during the phases i) and ii) (then during the treatment phase) are all equipped with an immobilization member manipulated manually by the operator.
Such therapy equipment has many disadvantages:
An aim of the present invention is to propose an intelligent and autonomous system, having robotic movements, vision, sensors and abilities to interpret the images generated by the integrated vision, to automate the phase of positioning the eyeball immobilization member.
To this end, the invention relates to a device for monitoring the movement of an ocular therapy apparatus of the type comprising:
Thus, the invention allows making the positioning phase of the therapy equipment more accurate, repeatable and at a lower cost than the existing solutions.
Preferred but non-limiting aspects of the monitoring device are the following:
The invention also relates to a method for monitoring the movement of an ocular therapy apparatus of the type comprising:
Preferred but non-limiting aspects of the monitoring method are the following:
Other characteristics and advantages of the invention will emerge clearly from the following description of several alternative embodiments, given by way of non-limiting examples, from the appended drawings wherein:
The invention relates to a device and method for monitoring the movement of a therapy apparatus for a human or an animal ocular tissue. In the following description, the invention will be described, by way of example, for the cutting of an ocular tissue, it being understood that the present invention can be used for any other type of ocular treatment.
Referring to
The therapy apparatus comprises:
The box 1 allows the movement of the therapy equipment. It comprises in particular wheels 11, a metal frame and an appropriate fairing so as to present a minimum of recesses in order to prevent dust or pathogenic elements from lodging therein and developing.
The box 1 preferably comprises means for immobilization with respect to the ground to prevent its movement during surgical intervention.
The box 1 carries the various elements of the therapy equipment—such as the arm 2 and the monitoring device 5—and comprises means for their supply with electrical energy.
The box 1 can further comprise display and input means 12—such as a planning console—allowing the practitioner to control the therapy equipment and/or follow the progress of the treatment applied to the patient's eye.
Finally, the box 1 can include communication means 13 with or without wire for the exchange of data with a remote workstation (not represented), or with the monitoring device 5 if the latter is not integrated into the box 1.
The arm 2 comprises several arm segments 21-24 connected by articulations 25-27 (pivot or ball-joint connections) to allow the movement in rotation of the different segments 21-24 relative to each other.
Each articulation 25-27 includes a motorization and a brake. Advantageously, each brake is of the active type in the case of absence of an electrical energy supply. This allows preventing any unexpected movement of the arm, for example in the event of a system failure or power outage.
The motorizations and brakes of the articulations of the arm allow:
Particularly, the arm is articulated to allow the movement of the free end of the arm along three orthogonal axes X, Y and Z:
The free end of the arm 2 includes an immobilization member equipped with a suction ring capable of suctioning the ocular tissue and holding it firmly in position. The monitoring device and method described below allow automatically positioning the immobilization member on the ocular tissue to be treated.
As illustrated in
The arm 2 is for example a TX260L marketed by the company STAUBLI.
The movement of the arm 2 is monitored by the monitoring device 5 which:
Advantageously, the arm may comprise declutching means to allow its movement manually, for example in the event of a failure or a power outage.
Referring to
The monitoring device 5 allows piloting the shaping system 200, the optical scanner 400 and the optical focusing system 500.
The femtosecond laser 100 is able to emit an initial LASER beam in the form of pulses. By “femtosecond laser” is meant a light source able to emit a LASER beam in the form of ultra-short pulses, the duration of which is comprised between 1 femtosecond and 100 picoseconds, preferably between 1 and 1000 femtoseconds, in particular on the order of around a hundred femtoseconds.
The shaping system 200 extends over the path of the initial LASER beam 110 derived from the femtosecond laser 100. It allows transforming the initial LASER beam 110 into a modulated LASER beam 210. More specifically, the shaping system allows modulating the phase of the LASER beam 110 to distribute the energy of the LASER beam into a plurality of impact points in its focal plane, this plurality of impact points defining a pattern. In other words, the shaping system 200 allows modulating the final energy distribution of the LASER beam in the focusing plane 710 corresponding to the tissue 700 cutting plane. It is adapted to modify the spatial profile of the wave front of the primary LASER beam 110 derived from the femtosecond laser 100 in order to distribute the energy of the LASER beam at different focal points in the focusing plane 710. The shaping system 200 therefore allows, from a Gaussian LASER beam generating a single impact point, and by means of the phase mask, distributing its energy by phase-modulation so as to simultaneously generate several impact points in its focusing plane from a single LASER beam shaped though phase-modulation (a single beam upstream and downstream of the SLM).
The optical coupler 300 allows transmitting the LASER 110 beam derived from the femtosecond laser 100 towards the shaping system 200. It advantageously comprises an optical fiber, in particular a hollow-core Photonic-Crystal Fiber (PCF). A hollow-core photonic crystal fiber is an optical fiber which guides light essentially inside a hollow region (the core of the fiber), so that only a minor part of the optical power propagates in the solid fiber material (typically a glass). The appeal for the hollow-core photonic crystal fibers are mainly that the primary guidance in the hollow region minimizes the non-linear effects of the modulated LASER beam and allows a high damage threshold. Advantageously, the hollow region of the hollow-core photonic crystal fiber can be placed under vacuum to limit the propagation losses of the LASER beam derived from the femtosecond laser 100. To this end, the optical coupler 300 comprises first and second connection cells sealingly mounted at each end of the hollow-core photonic crystal fiber. These connection cells are connected to a vacuum pump P integrated into the casing 1 to put the hollow core of the optical fiber under vacuum by pumping at the connection cells. The fact of carrying out a vacuum pumping at each end of the optical fiber 31 allows facilitating the vacuuming of the hollow core over the entire length of the optical fiber 31.
The optical scanner 400 allows orienting the modulated LASER beam 210 to move the pattern along a movement path predefined by the user in a focusing plane 710.
The optical focusing system 500 allows moving the focusing plane 710—corresponding to the cutting plane—of the deflected LASER beam 410 derived from the optical scanner 400.
Advantageously, the shaping system 200, the optical scanner 400 and the optical focusing system 500 can be mounted in a compartment fixed to the end 24 of the arm, while the femtosecond laser can be integrated into the box 1, the optical coupler 300 extending between the box 1 and the end segment 24 to propagate the initial laser beam 110 between the femtosecond laser 100 and the shaping system 200.
The force sensor 3 allows detecting mechanical forces generated in opposition to a movement of the arm 2, these forces which reflect the presence of an obstacle and which may correspond to obtaining a contact between the end of the arm 2 and the ocular tissue. The force sensor 3 can be mounted on the end segment 24 of the arm 2.
The force sensor 3 is of a type known per se to those skilled in the art. It is able to capture and measure compressive and tensile forces applied along the longitudinal axis of the end segment 24 of the arm 2. It comprises one (or more) strain gauge(s) mounted on the end segment 24 of the arm 2.
Each mechanical force measured by the force sensor 3 is transmitted to the monitoring device 5.
When the value of the measured mechanical force is greater than a threshold value, the monitoring device performs one or more predetermined action(s) (generation of an instruction to immobilize the arm, order of emission of a visual stimulus on display and input means 12, and/or of an auditory stimulus on a loudspeaker integrated into the box, etc.).
The acquisition system 4 allows acquiring measurement pairs used to monitor the movement of the arm 2 relative to the ocular tissue to be treated.
Each measurement pair comprises one (or more) image(s) of an area located facing the free end of the arm 2.
To this end, the acquisition system 4 may comprise an image acquisition unit of the OCT (Optical Coherence Tomography) or Scheimpflug (visible light mapping), or UBM (Ultrasonic Bio Microscopy) type. Such an image acquisition unit can be mounted on the end segment 24 of the arm 2, for example upstream of the optical scanner 400. This image acquisition unit is arranged so as to have a sufficiently wide acquisition field (for example observe a perimeter P corresponding to a square of a side of 50 cm at a distance of 30 cm) in order to be able to identify the ocular tissue in this acquisition field. Advantageously, the image acquisition unit can be equipped with (coaxial or non-coaxial) lighting means in order to facilitate recognition of the ocular tissue.
Each measurement pair also comprises one (or more) signal(s) representative of a distance between the free end of the arm 2 and the ocular tissue.
To this end, the acquisition system 4 may comprise a laser ranging unit or an ultrasonic ranging unit or an image-analysis ranging unit or a ranging by any other equivalent device known to those skilled in the art capable of acquiring a signal representative of a distance between the free end of the arm 2 and the object located facing this end. Such a ranging unit can also be mounted on the end segment 24 of the arm 2.
The monitoring device 5 allows:
The monitoring device 5 is connected to these different elements via one (or more) communication bus(es) allowing the transmission of control signals, and the receipt of acquisition data derived from the force sensor 3, of the acquisition system 4, etc.
The monitoring device 5 can be composed of one (or more) workstation(s), and/or one (or more) computer(s). The monitoring device 5 comprises a processor programmed to allow the piloting of the various elements of the therapy apparatus, and to allow the processing of the signals acquired by the force sensor 3 and the acquisition system 4.
The monitoring device 5 is programmed to implement the method illustrated in
The control means allow activating the acquisition system 4 to acquire a plurality of measurement pairs successively over time. More specifically, after each emission of an immobilization instruction by the servo-control means, the control means emit an activation signal from the acquisition system for the acquisition of a new measurement pair. This new measurement pair is processed by the processing means in order to update the deviation between the current position of the end of the arm and its desired final position.
The processing means are able, from each acquired measurement pair, to detect the three-dimensional position of the ocular tissue and the three-dimensional position of the end of the arm.
The three-dimensional position of the free end of the arm is known by construction.
The three-dimensional position of the ocular tissue is for its part obtained by calculation from the measurement pair derived from the acquisition system 4. For example in the image acquired by the acquisition system 4, the processing means are capable of identifying the ocular tissue, its two-dimensional position and its center by recognizing a shape close to a typical morphology of an eye (three concentric circles: a white circle (the sclera), in the center of which there is a colored circle (the iris) in the center of which there is a black circle (the pupil)). The third coordinate required to estimate the three-dimensional position of the ocular tissue is deduced from the signal acquired by the ranging unit, this signal being representative of the distance between the free end of the arm and the ocular tissue.
To process each measurement pair received from the acquisition system 4, the processing means comprise:
The servo-control means are programmed to implement a servo-control loop in the plane XY and a servo-control loop along the direction Z.
Advantageously, the movement of the free end of the arm 2 along the axes XY is uncorrelated from its movement along the axis Z. particularly the monitoring device 5 is programmed to:
This allows avoiding any risk of injury to the patient (for example by friction of the free end of the arm on the patient's eye if a movement in the plane XY was ordered while the end is already in contact with the ocular tissue).
The servo-control means of the monitoring device 5 are able to generate a plurality of successive movement instructions to move the free end of the arm from the initial deployed position to the desired final position in which the immobilization member is centered and in contact with the ocular tissue to be treated.
More specifically, if the distance between the current position of the end of the arm 2 and the desired final position is greater than a threshold value, the servo-control means generate a plurality of successive elementary movement instructions for bringing the end of the arm in the desired final position.
Between each emission of an elementary movement instruction, the servo-control means generate an immobilization instruction, and the control means emit an activation signal from the acquisition system 4 in order to acquire a new measurement pair. This allows verifying, throughout the movement of the arm 2, that its end is approaching the desired final position, and taking into account any unexpected movement of the patient's head (in which case the desired final position is updated).
The principle of operation of the therapy equipment will now be described in more detail with reference to
7.1. Prior to the Use of the Therapy Apparatus
As a pre-condition for the proper operation of the therapy apparatus described above, it should be specified that it will be required everywhere this apparatus is used, to define the position of the surgical equipment in the room with a floor marking, which position will be defined based on:
Once the floor marking has been defined, the therapy apparatus will be positioned in the same location at each use. In this way, the relative position of each patient with respect to the machine and in particular of his head and his eyes, is known with an acceptable margin of error, which can go up to 20 centimeters.
Thus, it is possible, by parameterization accessible via the man-machine interface of the apparatus, to define the coordinates of a perimeter P corresponding to a square with a side of 50 cm, in which will be positioned the head of each patient preparing to receive ocular therapy with the system object of the present invention (perimeter P of certain presence of the target). Once the coordinates of this perimeter P have been stored, at each use, the monitoring device 5 controls the positioning of the end of the arm (by default and before the iterations required to obtain perfect centering) in the middle of the perimeter P. This position corresponds to the initial deployed position.
The centering and contacting the immobilization member on the ocular tissue are carried out as follows.
7.2. Automatic Positioning of the Free End of the Arm on the Ocular Tissue
7.2.1. Deployment of the Arm
Once the patient is installed and the therapy apparatus is in place, the monitoring device 5 controls the deployment of the arm 2 (step 801).
The arm 2 moves automatically (as illustrated in the first four steps of
Once the center of the perimeter P has been reached, the iterations of the servo-control loop XY are initiated.
7.2.2. XY Servo-Control Loop
The XY servo-control loop is a programmed function which, at each iteration:
More specifically, the control means of the monitoring device 5 emit an activation signal from the acquisition system 4. The acquisition system 4 acquires an image and a signal representative of the distance between the end of the arm and the ocular tissue.
The processing means receive the measurement pair acquired by the acquisition system 4 and process it (step 803).
Particularly, the processing means:
The result of this comparison is transmitted to the servo-control means which:
Once the arm 2 has been moved in accordance with the movement instruction, the servo-control means generate an instruction to immobilize (step 806) the arm 2 and the previous steps (of activating the acquisition system 4, processing the measurement pair, etc.) are repeated until the desired final horizontal position in XY is reached by the free end of the arm 2.
7.2.3. Z Servo-Control Loop
Once the free end of arm 2 has been aligned in XY with the desired final horizontal position, the Z servo-control loop can be implemented.
The Z servo-control loop is a programmed function which, at each iteration:
More specifically, the processing means of the monitoring device 5 process the signal representative of a vertical distance along the axis Z (step 803), and compare (step 807) the current vertical position with the desired final vertical position.
The result of this comparison is transmitted to the servo-control means which also receive a signal measured by the force sensor 3. The servo-control means:
Once the arm 2 has been moved in accordance with the vertical movement instruction, the servo-control means generate an instruction to immobilize (step 809) the arm 2 and the previous steps are reiterated, including the steps of the XY servo-control loop, in order to check that the current horizontal position always corresponds to the desired final horizontal position.
This allows taking into account possible movements of the patient during the procedure for positioning the arm 2.
The monitoring device 5 allows positioning the free end of the arm in an accurate and centered manner. This free end carries the various working components allowing the treatment of the ocular tissue.
In a useful and reassuring way for the practitioner, the sequence of the different steps illustrated in
The invention described above allows, in a few seconds, automatically positioning on the eye of a patient a member for immobilizing the eyeball, without human intervention, in a rapid, accurate and repeatable manner. Its performances are independent of the environment, in order to gain accuracy, to make the gesture reproducible regardless of the patient or of the operator and to save time by dispensing the operator from a low-value-added task.
The invention further allows providing more safety and therefore reducing the risk run by the patient at the time of the intervention.
The reader will understand that many modifications can be made to the invention described above without physically departing from the new teachings and advantages described here. For example, in the description above, the immobilization member was mounted on the free end of the robotic arm. Alternatively, the immobilization member can be separated from the robotic arm. In this case, the immobilization member is positioned on the patient's eye prior to the movement of the robotic arm, and the desired final position corresponds to contacting the free end of the robotic arm with one face of the immobilization member opposite to the surface of the immobilization member in contact with the eye. Consequently, all modifications of this type are intended to be incorporated within the scope of the appended claims.
Number | Date | Country | Kind |
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1850578 | Jan 2018 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2019/051876 | 1/25/2019 | WO | 00 |