Avoiding blood vessels during direct selective laser trabeculoplasty

The system addresses the challenge of avoiding blood vessels and sensitive structures in laser trabeculoplasty by dynamically adjusting the treatment pathway and using vasoconstrictive agents, achieving precise and safe laser treatment.

JP2026110614APending Publication Date: 2026-07-02BELKIN VISION LTD

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
BELKIN VISION LTD
Filing Date
2026-04-13
Publication Date
2026-07-02

AI Technical Summary

Technical Problem

Existing laser trabeculoplasty techniques face challenges in avoiding irradiation of blood vessels and other sensitive anatomical structures during treatment, which can lead to adverse effects such as bleeding and reduced treatment effectiveness.

Method used

A system and method that uses a controller to define a treatment pathway around blood vessels, continuously monitor the eye during treatment, adjust the treatment pathway in response to observed changes, and utilize vasoconstrictive agents to minimize bleeding, while employing imaging and motor feedback to ensure accurate laser targeting.

Benefits of technology

Effectively avoids sensitive areas, maintains treatment effectiveness by selectively modifying the treatment pathway, and reduces adverse effects like bleeding, ensuring precise and safe laser trabeculoplasty.

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Abstract

To provide ophthalmic devices and methods for treating glaucoma, ocular hypertension (OHT), and other diseases. [Solution] The system comprises a radiation source (48) and a controller (44). The controller is configured to: designate multiple target regions (84) of the patient's (22) eye (25) to irradiate with different amounts of energy; cause the radiation source to irradiate at least a first target region of the multiple target regions; after causing the radiation source to irradiate at least a first target region of the multiple target regions, process an image of the eye to identify changes in the eye; and in response to the identification of changes in the eye, cause the radiation source to refrain from irradiating a second target region of the multiple target regions that have not yet been irradiated with the amount of energy specified for the second target region. Other embodiments are also described.
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Description

Technical Field

[0001] The present invention relates to ophthalmic devices and methods for treating glaucoma, ocular hypertension (OHT), and other diseases.

[0002] (Cross-reference to Related Applications) This application is a continuation-in-part of U.S. Patent Application No. 17 / 136,052, titled "Avoidance of Blood Vessels During Direct Selective Laser Trabeculoplasty," filed on December 29, 2020 (Patent Document 1), the disclosure of which is incorporated herein by reference. Further, this application claims the benefit of U.S. Provisional Patent Application No. 63 / 105,388, titled "Vasoconstrictors for Use in Laser Ophthalmic Surgery," filed on October 26, 2020 (Patent Document 2), the disclosure of which is incorporated herein by reference.

Background Art

[0003] U.S. Patent No. 5,422,899 (Patent Document 3) describes an optically excited mid-infrared solid laser with a high pulse repetition rate for use in laser surgery. The laser generates a wavelength of 1.7 to 4.0 micrometers and is optically excited.

[0004] U.S. Patent No. 6,761,713 (Patent Document 4) describes a medical laser unit including at least one laser body made of a laser material. A first type of pump source is designed and arranged to continuously excite the laser material and generate continuous laser radiation. A second type of pump source is designed and arranged to excite the laser material by pulses and generate pulsed laser radiation. The transmission unit is designed and arranged to transmit continuous laser radiation and pulsed laser radiation to a surgical application site. More specifically, the medical laser unit has two operating modes: a first mode for cutting by continuous laser radiation and a second mode for fragmentation by pulsed laser radiation of high-power laser pulses in a short time.

[0005] U.S. Patent No. 8,160,113 (Patent Document 5) describes output pulses from an optical system having a seed source and an optical amplifier coupled to the seed source, which can be controlled by controlling the power of the seed signal from the seed source. The seed signal can vary between a minimum and a maximum value such that the seed signal exhibits one or more pulse bursts. Each pulse burst may contain one or more pulses. During inter-pulse periods between consecutive pulses within a pulse burst or between consecutive pulse bursts, the power of the seed signal can be adjusted to an intermediate value greater than the minimum and less than the maximum. The intermediate value is selected to control the gain of the optical amplifier so that the pulses or pulse bursts following the period exhibit desired behavior.

[0006] U.S. Patent No. 5,982,789 (Patent Document 6) describes a diode pump doubling system that uses a pump diode, a crystal, and a doubler in a laser cavity containing the diode, and operates in a pulsed or low duty cycle pumping manner. In response to pulsed diode operation, it produces a stable known or controlled energy output in a non-CW pumping regime. In a preferred embodiment, the device is operated by a control system that uses a doubler fixed across its noncritical axis and generates an isotherm in the active mode volume. The controller operates one or more separate heat sources and / or sinks to preheat the diode source or doubling crystal and maintain a directed temperature gradient. The speed or direction in which the isotherm moves across the mode volume is controlled according to the following pulse sequence to maintain an effectively stable state during laser operation. The thermal control system may include sinks, heaters, and control elements for preheating the laser diode before operation and during rest periods.

[0007] U.S. Patent No. 5,151,909 (Patent Document 7) describes a laser system using a nonlinear crystal and a solid-gain medium for second harmonic generation, operating under the control of a data processor, to enable multiple pump power modes. The data processor modulates the pump power in low-power mode and supplies continuous pump power in combination with Q-switching in high-power mode. Alternatively, modulation can be used in both low-power and high-power modes, and the modulation parameters can be adjusted programmatically. Second harmonic generation without Q-switching in high-power mode can also be achieved in a similar manner.

[0008] U.S. Patent No. 6,414,980 (Patent Document 8) describes a method for operating an out-of-cavity frequency-converted solid-state laser to perform a laser processing operation. The laser comprises a laser resonator containing an optically pumped gain medium. The resonator is configured to compensate for a predetermined range of thermal lensing effects in the gain medium. An optically nonlinear crystal positioned outside the resonator converts the fundamental laser radiation supplied by the resonator into frequency-converted radiation. The laser processing operation is performed by a series of pulses of frequency-converted radiation having sufficient power to perform the processing operation. The output of the frequency-converted radiation depends on the delivery parameters of the laser radiation from the laser resonator. The laser is operated before and during the laser processing operation so that the resonator effectively delivers the same average power of the fundamental laser radiation. This ensures that the thermal lensing effect in the gain medium is within a predetermined range before and during the laser processing operation. The delivery parameters of the laser radiation before and during the processing operation are modified so that the output of the frequency-converted radiation generated before the processing operation is insufficient to perform the laser processing operation.

[0009] In laser trabeculoplasty, one or more therapeutic beams of laser are directed at the trabecular meshwork of the patient's eye to lower intraocular pressure. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Patent Application 17 / 136,052 [Patent Document 2] U.S. Provisional Patent Application 63 / 105,388 [Patent Document 3] U.S. Patent No. 5,422,899 [Patent Document 4] U.S. Patent No. 6,761,713 [Patent Document 5] U.S. Patent No. 8,160,113 [Patent Document 6] U.S. Patent No. 5,982,789 [Patent Document 7] U.S. Patent No. 5,151,909 [Patent Document 8] U.S. Patent No. 6,414,980 [Overview of the Initiative]

[0011] According to some embodiments of the present invention, a system is provided having a radiation source and a controller. The controller is configured to: designate a plurality of target areas of a patient's eye to irradiate with a respective amount of energy; cause the radiation source to irradiate at least a first target area of ​​the plurality of target areas; after causing the radiation source to irradiate at least a first target area of ​​the plurality of target areas, identify changes in the eye by processing an image of the eye; and, in response to the identification of changes in the eye, cause the radiation source to refrain from irradiating a second target area of ​​the plurality of target areas that has not yet been irradiated with the amount of energy designated for the second target area.

[0012] In some embodiments, the controller specifies a new target region and causes the radiation source to irradiate the new target region instead of the second target region.

[0013] In some embodiments, the controller causes the radiation source to irradiate the second target region with a different energy amount, which is less than the energy amount specified for the second target region among a plurality of target regions, thereby refraining from irradiating the second target region with the energy amount specified for the second target region.

[0014] In some embodiments, the change includes bleeding. In some embodiments, the change includes expansion. In some embodiments, the change includes a change in color. In some embodiments, the variation involves the formation of one or more bubbles. In some embodiments, the controller is configured to refrain from irradiating the second target region with the radiation source, depending on the distance between the second target region and another region of the eye.

[0015] In some embodiments, the controller is further configured to identify anatomical features in a second target region, and in response to the identification of anatomical features, the controller is configured to refrain from irradiating the second target region with a radiation source. In some embodiments, the controller is further configured to calculate a predictive measure of overlap between a radiation beam irradiating a second target region and anatomical features, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the predictive measure of overlap.

[0016] In some embodiments, the anatomical feature is the anatomical feature of a second target region, and the controller is further configured to identify the anatomical feature of the first target region in the first target region, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the identification of the anatomical feature of the first target region. In some embodiments, the controller is configured to refrain from irradiating the second target region with the radiation source in response to the anatomical features of the first target region and the anatomical features of the second target region being of the same type.

[0017] In some embodiments, the controller is further configured to calculate an estimated measure of overlap between (a) a first radiation beam that irradiates the first target region and (b) the anatomical features of the first target region, and to calculate a predicted measure of overlap between (a) a second radiation beam that irradiates the second target region and (b) the anatomical features of the first target region, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the predicted measure of overlap and the estimated measure of overlap.

[0018] In some embodiments, the controller is further configured to calculate an estimated amount of energy delivered to the anatomical features of the first target region by the first radiation beam, and to calculate a predicted amount of energy delivered to the anatomical features of the second target region by the second radiation beam, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the estimated amount of energy and the predicted amount of energy.

[0019] In some embodiments, the controller is further configured to calculate a risk measure associated with irradiating the second target region, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the risk measure. In some embodiments, the controller is configured to calculate the risk measure based on the patient's medical profile. In some embodiments, the controller is further configured to identify anatomical features in the second target region, and the controller is configured to calculate the risk measure based on the type of the anatomical features in the second target region.

[0020] According to some embodiments of the present invention, there is further provided a method comprising: specifying a plurality of target regions of a patient's eye for irradiating each amount of energy; irradiating at least a first region of the target regions to a radiation source; subsequently, irradiating at least the first region of the plurality of target regions to the radiation source by processing an image of the eye to identify a change in the eye; and holding to irradiate a second target region not yet irradiated to the radiation source with an energy amount specified for the second target region in response to the identification of the change. A method characterized by having these steps is provided.

[0021] According to some embodiments of the present invention, there is further provided a system having a radiation source and a controller. The controller is configured to: acquire an image of the eye, identify a plurality of end points at different respective angles with respect to a reference point in the image, where the reference point is located above the eye radially inward from the end points, each of the end points is at an end of each blood vessel, and define a plurality of target regions of the eye between the reference point and the end points, and irradiate the target regions to the radiation source.

[0022] In some embodiments, the reference point is located at the center of the iris of the eye. In some embodiments, the reference point is located at the center of the limbus of the eye. In some embodiments, the reference point is located at the center of the pupil of the eye. In some embodiments, for each angle, the end of each blood vessel is closer to the reference point than the other end of the blood vessel at that angle. In some embodiments, the controller is configured to define the target regions by: defining at least one treatment path between the end points and the reference point; and defining the target regions such that each of the target regions is on the treatment path.

[0023] In some embodiments, the controller is configured to define the treatment path such that the shortest distance between any one of the end points and the treatment path is at least 0.001 mm. In some embodiments, the controller defines at least one curve passing through an endpoint, offsets the curve toward a reference point, and defines a treatment path in response to the offset curve. In some embodiments, the controller is configured to define a treatment path in response to an offset curve by defining the treatment path as the perimeter of a predetermined shape inscribed within the offset curve.

[0024] In some embodiments, the predetermined shape is an ellipse. In some embodiments, the controller is configured to define a treatment path in response to an offset curve by defining the treatment path as the perimeter of a predetermined shape with the largest area inscribed in the offset curve. In some embodiments, the controller is configured to define the treatment path in response to an offset curve by defining the treatment path as the perimeter of a predetermined shape with the largest area inscribed in the offset curve, centered on a reference point. In some embodiments, the controller is configured to define a treatment path in response to an offset curve by defining the treatment path as a closed curve that is inscribed in the offset curve and has the shape of the limbus of the eye's cornea.

[0025] According to some embodiments of the present invention, a method is provided comprising: the steps of: acquiring an image of an eye; identifying a plurality of endpoints in the image at different angles, wherein a reference point is located in the eye radially inward from the endpoints, and each of the endpoints is located on the end of a respective blood vessel; defining a plurality of target regions on the eye between the reference point and the endpoints; and causing a radiation source to irradiate the target regions.

[0026] According to some embodiments of the present invention, a system comprising a radiation source and a controller is provided. The controller is configured to acquire an image of the eye, identify a plurality of endpoints in the image at different angles with respect to a reference point, where the reference point is located in the eye radially inward from the endpoints, and each endpoint is at the end of a respective blood vessel, define at least one curve passing through the endpoint, offset the curve toward the reference point, receive definitions of a plurality of target regions of the eye from the user while displaying the offset curve to the user, and cause the radiation source to irradiate the target regions.

[0027] According to some embodiments of the present invention, a method is provided comprising: acquiring an image of an eye; identifying a plurality of endpoints in the image at different angles with respect to a reference point, wherein the reference point is located in the eye radially inward from the endpoints, and each of the endpoints is at the end of a respective blood vessel; defining at least one curve passing through the endpoints; offsetting the curve toward the reference point; receiving definitions of a plurality of target regions of the eye from the user while displaying the offset curve to the user; and causing a radiation source to irradiate the target regions.

[0028] According to some embodiments of the present invention, a method is provided which is characterized by: administering an α2 agonist to a patient's eye; and treating the patient's eye with laser irradiation within 40 minutes after administration of the α2 agonist. In some embodiments, the step of treating a patient's eye includes the step of treating the patient's eye by irradiating the trabecular network of the eye with laser radiation. In some embodiments, the step of treating the patient's eye includes treating the patient's eye within 30 minutes after administering an α2 agonist. In some embodiments, the step of treating the patient's eye includes treating the patient's eye in response to a signal from a controller that the blood vessels in the eye have been sufficiently constricted by an α2 agonist.

[0029] According to some embodiments of the present invention, an α2 agonist is further provided for use in a method of constricting a patient's eye. The α2 agonist is administered to the patient within 40 minutes of treating the eye with laser irradiation. According to some embodiments of the present invention, (CL70) is further provided.

[0030] According to some embodiments of the present invention, a system is provided comprising: a laser including a pump source and a laser medium; and a controller. The controller is configured to: sequentially designate multiple target areas of a patient's eye for laser irradiation, drive the pump source to start pumping the laser medium with a sequence of laser oscillation generating pulses, each configured to cause the laser medium to oscillate, thereby initiating irradiation of the target areas; and, following the initiation of irradiation of the target areas, cause the pump source to replace one of the laser oscillation generating pulses with one or more heating pulses, the heating pulses configured to heat the laser medium without causing it to oscillate.

[0031] In some embodiments, the controller is further configured to heat the laser medium without causing it to oscillate before initiating irradiation of the target area. In some embodiments, the total energy of the heating pulse is between 70-100% of the energy of each laser oscillation generation pulse. In some embodiments, one or more heating pulses consist of N>1 heating pulses. In some embodiments, each heating pulse has a heating pulse duration of D0 / N, where D0 is the duration of each laser oscillation generation pulse. In some embodiments, each heating pulse has a peak power equal to the peak power of each laser oscillation generation pulse.

[0032] In some embodiments, the sequence of laser oscillation generation pulses is periodic with period T, and the controller is configured to replace the pump source with a heating pulse at a time {k*T / N}, k=0...N-1, from the moment one of the laser oscillation generation pulses is pumped. In some embodiments, the controller is configured to replace the pump source with a heating pulse in response to an error signal. In some embodiments, the controller is further configured to process one or more images of the eye acquired by the camera, and the controller is configured to cause a pump source to be replaced with a heating pulse in response to the processing of the images. In some embodiments, the controller is configured to identify an eye injury by processing an image, and the controller is configured to replace the pump source with a heating pulse in response to the identification of the eye injury.

[0033] In some embodiments, the controller is configured to identify changes in the eye by processing an image, and the controller is configured to replace the pump source with a heating pulse in response to the identification of changes in the eye. In some embodiments, the eye change includes the formation of one or more bubbles. In some embodiments, the controller is configured to determine the reference point position of a reference point on the eye by processing an image, the controller is further configured to calculate a target region position based on the reference point position, and to confirm that the laser is not directed at the target region position, and the controller is configured to cause a pump source to be replaced with a heating pulse in response to the confirmation.

[0034] In some embodiments, the system further comprises one or more motors, and the controller is further configured to use the motors to aim the laser, and the controller is configured to ensure that the laser is not pointed at a target area in response to respective signals from each encoder of the motors. In some embodiments, the laser is a therapeutic laser, the system further comprises a targeting laser, and the controller is further configured to: cause the targeting laser to emit a targeting beam to the position the therapeutic laser is aiming at, identify the targeting beam position of the targeting beam by processing an image, and the controller is configured to confirm that the therapeutic laser is not aimed at the target area position based on the deviation between the targeting beam position and the target area position.

[0035] In some embodiments, the wavelength of the aiming beam is greater than 700 nm. In some embodiments, the image comprises a first image acquired while the aiming beam is being emitted and in which the aiming beam appears in the first image, and a second image acquired before or after the aiming beam is being emitted and in which the aiming beam does not appear in the second image, wherein the controller is configured to identify the aiming beam position in the first image and the controller is configured to identify the reference point position in the second image.

[0036] In some embodiments, the image consists of a single image including a first frame in which the aiming beam appears and a second frame in which the aiming beam does not appear, the controller is configured to identify the position of the aiming beam in the first frame and the controller is configured to identify the position of the reference point in the second frame. According to some embodiments of the present invention, a method is provided comprising: specifying a plurality of target areas of a patient's eye for continuous irradiation with a laser; initiating irradiation of the target areas by driving a pump source to begin pumping a laser medium with a series of laser oscillation generating pulses, each configured to cause the laser medium of the laser to oscillate; and, following the step of initiating irradiation of the target areas, instructing the pump source to replace one of the laser oscillation generating pulses with one or more heating pulses, wherein the heating pulses are configured to heat the laser medium without causing the laser medium to oscillate. [Brief explanation of the drawing]

[0037] The present invention will be better understood by reading the following detailed description of embodiments in conjunction with the drawings: [Figure 1] This is a schematic diagram of a system for performing trabecular meshwork treatment according to several embodiments of the present invention. [Figure 2] This is a schematic diagram of a fiber trabecular strip forming apparatus according to several embodiments of the present invention. [Figure 3] This is a schematic diagram of a technique for defining a target area above the eye, according to several embodiments of the present invention. [Figure 4] This is a flowchart of an algorithm for defining a target region according to several embodiments of the present invention. [Figure 5] This is a flowchart of an algorithm for performing automated trabeculoplasty according to several embodiments of the present invention. [Figure 6A] This is a flowchart showing the image processing steps according to each of the different embodiments of the present invention. [Figure 6B] This is a flowchart showing the image processing steps according to each of the different embodiments of the present invention. [Figure 7] This is a flowchart of the check steps according to several embodiments of the present invention. [Figure 8]This figure shows examples of the check step and target region shift step according to several embodiments of the present invention. [Figure 9] This is a schematic diagram of the timelines of the pulses that cause laser oscillation and the heating pulses according to some embodiments of the present invention. [Modes for carrying out the invention]

[0038] (overview) When performing laser trabeculoplasty on the eye, it is desirable to avoid irradiating blood vessels and other sensitive anatomical structures due to the risk of bleeding and other adverse effects.

[0039] To address this challenge, embodiments of the present invention provide a technique for defining a treatment pathway that avoids blood vessels in the eye. Following the definition of the treatment pathway, multiple target regions along the treatment pathway are defined, and then the target regions are irradiated.

[0040] To define the treatment pathway, the controller first identifies several points on the inner edge of the blood vessels surrounding the limbus of the eye's cornea. Next, the controller defines a curve passing through these points. Then, the controller offsets the curve inward toward the center of the eye. Finally, the controller draws the treatment pathway within the offset curve.

[0041] Despite the above, in some cases, it may not be possible to define the treatment route as described above, for example, due to the abnormal distribution of blood vessels in the eye. Furthermore, irradiation of sensitive areas other than blood vessels, such as tumors, may also have adverse effects.

[0042] One hypothesis is that, considering this challenge, it might be possible to cut out parts of the treatment pathway that pass through blood vessels and other sensitive areas; however, as the inventors have observed, it is generally impossible to know a priori the degree of the eye's sensitivity to radiation. For example, in some patients, direct application of a laser beam to blood vessels does not cause bleeding. Therefore, avoiding all sensitive areas of the eye may unnecessarily reduce the effectiveness of the treatment for some patients.

[0043] To address this challenge, embodiments of the present invention allow the treatment pathway to pass through sensitive areas, while continuously monitoring the eye using appropriate imaging techniques as treatment progresses. If problematic changes in the eye (such as bleeding) are observed, the controller assesses, for each subsequent target area, the likelihood that irradiation of the next target area will cause similar changes. In response to a high probability, the controller may shift or skip the next target area. Therefore, advantageously, the treatment pathway is selectively modified without unnecessarily impairing the effectiveness of the treatment.

[0044] For example, in response to observing changes in an irradiated target area, the controller may calculate a risk scale that depends on the type of sensitive anatomical feature in the irradiated target area (if such a feature exists), an estimate of the radiation energy delivered to this sensitive anatomical feature, the type of sensitive anatomical feature in the next target area (if such a feature exists), and an estimate of the radiation energy delivered to the next sensitive anatomical feature. In response to a risk scale exceeding a predetermined threshold, the controller may shift or skip the next target area.

[0045] Alternatively or additionally, to reduce the amount of bleeding that occurs (for example, to prevent bleeding), the eye may be treated with a vasoconstrictive α2 agonist such as apraclonidine and / or brimonidine before irradiation (for example, within 40 minutes prior). After administration of the α2 agonist, the controller can monitor the degree of ocular vasoconstriction by processing images of the eye. In response to confirmation that the blood vessels have constricted sufficiently, the controller may issue an instruction to begin irradiation to the eye.

[0046] In addition to monitoring the eye for problematic changes, the controller continuously checks for obstructions lying along the treatment path using appropriate imaging techniques. In response to the detection of obstructions, one or more target areas may be shifted or skipped.

[0047] Typically, immediately before irradiating each target area, the controller checks whether the laser is directed to the target area, taking into account eye movements following the demarcation of the target area. (This check is usually performed in addition to the check for eye changes or impairments described above.) If the laser is not directed to the location, or if the location cannot be calculated, the controller aborts the imminent irradiation. It can then acquire and process another image of the eye and retry irradiating the target area. Alternatively, it may skip the target area.

[0048] To verify that the laser is properly aimed, the controller may process signals received from a motor encoder that determines the direction of the beam guide element used to aim the laser. Alternatively or additionally, the controller may process images of the eye acquired by a camera to determine the position of the aiming beam striking the eye at the position where the laser is aimed. In such embodiments, the aiming beam may be invisible to the patient (visible to the camera) so as not to interfere with the patient. Alternatively or additionally, the aiming beam may be configured and / or controlled so as not to interfere with tracking eye movement. For example, the camera may have a filter matrix that filters the wavelength of the aiming beam so that the image includes a first frame in which the aiming beam appears and a second frame in which the aiming beam does not appear. Alternatively, the controller may acquire a first image while the aiming beam is emitting and a second image while the aiming beam is not emitting. The controller can then determine the position of the aiming beam in the first image or frame, but track eye movement based on the second image or frame.

[0049] In some embodiments, in response to a decision to abort an imminent irradiation of a target area (e.g., due to an obstacle, a change such as bleeding, or improper laser aiming), the controller drives the laser's pump source to pump the laser medium with one or more heating pulses. Typically, the total energy of the heating pulses is approximately equal to the energy that would have been delivered to the laser medium if the controller had decided to continue the imminent irradiation. However, this total energy is diffused over a sufficiently long period of time so that the laser medium does not oscillate. Thus, advantageously, the thermal equilibrium of the laser can be maintained until the target area (or, if the target area is skipped, the next target area) is irradiated. Alternatively or additionally, the laser medium can be pumped with heating pulses to reach thermal equilibrium before the first treatment beam is emitted, prior to the commencement of treatment. On the other hand, if the laser medium is left unheated for a period of time, the irradiation energy of at least the first treatment beam emitted by the laser following that period may be lower than the desired energy, and / or the beam profile or beam aiming may become unstable.

[0050] (System description) First, refer to Figure 1, a schematic diagram of a system 20 including a trabeculoplasty apparatus 21 for performing trabeculoplasty. Further refer to Figure 2, a schematic diagram of a trabeculoplasty apparatus 21 according to several embodiments of the present invention.

[0051] The trabecular meshwork apparatus 21 comprises an optical unit 30 and a controller 44. The optical unit 30 includes a radiation source 48 configured to irradiate one or more therapeutic beams onto the eye 25 of the patient 22 (for example, the trabecular meshwork of the eye 25).

[0052] Typically, the radiation source 48 includes a therapeutic laser 43, such as an Ekspla® NL204-0.5K-SH laser. The therapeutic laser 43 includes a laser medium 45, which may include, for example, a semiconductor, glass, or a crystal such as a neodymium-doped yttrium aluminum garnet (Nd:YAG) crystal. The laser medium 45 may be pumped by any suitable pump source 47, such as a laser diode. The pumping may be optical, electrical, or of other suitable types. The therapeutic laser 43 further comprises a plurality of mirrors 49 arranged to define a stable or unstable resonant cavity. (Each mirror 49 may be an independent element or may have a reflective coating coating another element.) The therapeutic laser 43 further comprises a heat reservoir 57 that removes heat from the laser medium 45.

[0053] In some embodiments, the laser further comprises a Q-switch (QS) 63. Alternatively or additionally, the laser may include a second harmonic generation (SHG) crystal 51 that converts the wavelength emitted by the laser medium 45 to another wavelength suitable for treatment. (The SHG crystal 51 may be inside or outside the resonant cavity.) The laser may be modified to include an attenuator, energy meter, and / or mechanical shutter, typically located outside the resonant cavity.

[0054] Typically, the radiation source is further equipped with a driver 53, and the controller 44 drives the pump source 47 via the driver 53 to pump the laser medium 45. In particular, the driver 53 receives a control signal 55 from the controller 44, usually via a cable 59. In response to the control signal 55, the driver outputs an electric drive signal to the pump source 47, which in turn pumps the laser medium. In other embodiments, the controller directly drives the pump source 47 by outputting a drive signal to the pump source.

[0055] The optical unit 30 further includes one or more beam-guiding elements, including, for example, one or more (e.g., two) Garbo mirrors 50 collectively referred to as “Garbo scanners.” Before emitting each therapeutic beam 52, the controller 44 directs the therapeutic laser 43 to a desired target area of ​​the eye 25 by orienting the beam-guiding elements toward the target area. (Since each therapeutic beam strikes the eye with a non-infinitely small spot size, this application generally describes each beam as striking an “area” of the eye rather than a “point” of the eye.) Therefore, for example, the beam can be deflected by the Garbo mirror 50 toward the beam combiner 56, and then deflected by the beam combiner so that the beam collides with the target region. Thus, the beam follows a path 92 extending from the downstream end of the optical elements in the optical unit 30, such as the beam combiner 56, to the eye 25.

[0056] Typically, the controller orients the beam guide elements (and thus aims the laser) by communicating control signals 39 (e.g., via cable 23) to each aiming motor 61 of the beam guide elements. Typically, the controller receives feedback signals 37 (e.g., via cable 23 or different cables) from each encoder 67 of the aiming motor 61 indicating the orientation of each beam guide element.

[0057] In some embodiments, the treatment beam includes visible light. Alternatively or additionally, the treatment beam may include non-visible electromagnetic radiation such as microwave radiation, infrared radiation, X-ray radiation, gamma radiation, or ultraviolet radiation. Typically, the wavelength of the treatment beam is between 200 and 11000 nm, for example, 500 to 850 nm, for example, 520 to 540 nm, for example, 532 nm. The spatial profile of each treatment beam 52 over the eye may be elliptical (e.g., circular), square, or any other suitable shape.

[0058] In some embodiments, the radiation source 48 further comprises a targeting laser configured to emit a visible or invisible (e.g., infrared) targeting beam. The targeting laser sufficiently overlaps with the therapeutic laser 43, and for any orientation of the beam directing element, the beam directing element directs the targeting beam and the therapeutic beam to the same position. Thus, the targeting laser can facilitate the targeting of the therapeutic laser, as will be further described below with reference to Figure 6B.

[0059] In place of, or in addition to, the laser, the radiation source may include any other suitable emitter configured to emit a therapeutic beam or a targeting beam.

[0060] The optical unit 30 further comprises a camera 54 used by the controller 44 to acquire an image of the eye. As shown in Figure 2, the camera 54 is typically at least substantially aligned with the path 92. For example, the angle between the path 92 and a virtual line extending from the eye 25 to the camera may be less than 15 degrees. In some embodiments, the camera is positioned behind a beam combiner 56 and receives light through the beam combiner. In other embodiments, the camera is offset from the beam combiner.

[0061] Prior to the procedure, the camera 54 acquires at least one image of the eye 25. Based on the image, the controller 44 can define the target area of ​​the eye to be irradiated, as further described below with reference to Figure 3-4. Alternatively or additionally, the controller 44 may, based on the image, identify one or more blood vessels or other anatomical features of the eye, as further described below with reference to Figure 4-5.

[0062] Subsequently, during treatment, the camera 54 can acquire multiple images of the patient's eye at a relatively high frequency. The controller 44 can process these images and, in response, control the radiation source 48 and beam guide elements to irradiate the target area of ​​the eye while avoiding obstacles and potentially sensitive anatomical features, as will be further described below with reference to 6A-B and Figure 7.

[0063] Generally, the camera 54 comprises multiple image sensors of any suitable type, such as charge-coupled device (CCD) sensors, complementary metal-oxide-semiconductor (CMOS) sensors, optical coherence tomography (OCT) sensors, and / or hyperspectral image sensors. Using the sensors, the camera can acquire any suitable type of two-dimensional or three-dimensional image, such as monochrome images, color images (for example, based on three color frames), multispectral images, hyperspectral images, optical coherence tomography (OCT) images, or images generated by fusing multiple images of different types.

[0064] In some embodiments, the optical unit 30 further includes a light source 66, which is aligned with at least substantially the path 92. For example, the angle between the path 92 and a virtual line extending from the end of the path 92 on the eye 25 to the light source 66 may be less than 20 degrees, such as less than 10 degrees. The light source 66 is configured to function as a fixation target 64 by transmitting visible fixation light 68, and thus helps to stabilize the position of the eye.

[0065] In particular, before treatment, the patient 22 is instructed to fixate on the light source 66 with the eye 25. Subsequently, during treatment, the eye 25 gazes at the light source thanks to the light source 66 transmitting fixation light 68. The line of sight of the eye is approximately coincident with the path 92 (because the light source is approximately aligned with the path), and the eye is relatively stable. While the eye is gazing at the light source, the radiation source irradiates the eye with a treatment beam 52.

[0066] In some embodiments, the light source 66 includes a light-emitting element such as a light-emitting diode (LED). In other embodiments, the light source includes a reflector configured to reflect light emitted from a light emitter.

[0067] Typically, the wavelength of the fixation light 68 may be higher or lower than the wavelength of the treatment beam, but it is between 350 and 850 nm. For example, the fixation light 68 may be orange or red with a wavelength of 600 to 750 nm, while the treatment beam may be green with a wavelength of 527 to 537 nm.

[0068] Typically, an optical unit comprises an optical bench, and at least some of the aforementioned optical elements belonging to the optical unit, such as a radiation source, a Garbo mirror, and a beam combiner, are coupled to the optical bench. Typically, the optical unit further comprises a front 33 through which the therapeutic beam and fixation light pass. For example, an optical unit 30 may comprise a housing 31 that at least partially encloses the optical bench and comprises the front 33 (the housing 31 may be made of plastic, metal, and / or any other suitable material). The front 33 may be mounted on an optical table or may be an integral part of the optical table.

[0069] In some embodiments, the front surface 33 is shaped to define an opening 58 through which the treatment beam and fixation light pass. In other embodiments, the front surface has an exit window instead of an opening 58, allowing the fixation light 68 and treatment beam 52 to pass through the exit window. The exit window can be made of plastic, glass, or other suitable material.

[0070] Typically, the optical unit 30 further comprises one or more illumination sources 60, including one or more LEDs, such as white light or infrared LEDs. For example, the optical unit may comprise a ring of LEDs surrounding the aperture 58. In such embodiments, the controller 44 may cause the illumination sources 60 to intermittently flash light to the eye, as described in U.S. Patent Application Publication 2021 / 0267800, whose disclosure is incorporated herein by reference. This flashing facilitates imaging by the camera and, depending on the brightness of the flashing light, further helps to constrict the pupil without damaging the eye or causing discomfort to the patient. (For ease of explanation, the electrical connections between the controller 44 and the illumination sources 60 are not explicitly shown in Figure 2.) In some embodiments, the illumination sources 60 are coupled to the front 33 as shown in Figure 2.

[0071] To facilitate the positioning of the optical unit, the optical unit may comprise a plurality of beam emitters 62 (each including, for example, a laser diode), which are configured to project a plurality of triangulation beams onto the eye, as described, for example, in U.S. Patent Application Publication No. 2021 / 0267800, the disclosure of which is incorporated herein by reference. In some embodiments, the beam emitters 62 are coupled to the front surface 33, as shown in Figure 2. In other embodiments, the beam emitters 62 are directly coupled to the optical bench.

[0072] The optical unit 30 is mounted on an XYZ stage unit 32, which is controlled by a control mechanism 36, such as a joystick. Using the control mechanism 36, a user of the system 20, such as an ophthalmologist, can position the optical unit before treating the eye (for example, by adjusting the distance from the eye to the optical unit). In some embodiments, the XYZ stage unit 32 includes a locking element configured to prevent movement of the stage unit following the positioning of the stage unit.

[0073] In some embodiments, the XYZ stage unit 32 includes one or more motors 34, and the control mechanism 36 is connected to an interface circuit 46. When a user operates the control mechanism, the interface circuit 46 converts this activity into appropriate electronic signals and outputs these signals. In response to the signals, the controller controls the motors of the XYZ stage unit.

[0074] In other embodiments, the XYZ stage unit 32 is manually controlled by operating a control mechanism. In such embodiments, the XYZ stage unit may have a set of gears instead of the motor 34.

[0075] The system 20 further comprises a headrest 24 having a forehead rest 26 and a chin rest 28. During trabeculoplasty treatment, the patient 22 presses their forehead against the forehead rest 26 while resting their chin on the chin rest 28. In some embodiments, the headrest 24 further comprises a restraint strap 27 configured to secure the patient's head from behind and keep the patient's head pressed against the headrest.

[0076] In some embodiments, as shown in Figure 1, both the headrest 24 and the XYZ stage unit 32 are mounted on a surface 38, such as a tray or tabletop. (In some such embodiments, the headrest is L-shaped and mounted on the side of the surface 38 rather than the top surface.) In other embodiments, the XYZ stage unit is mounted on the surface 38 and the headrest is mounted on the XYZ stage unit.

[0077] Typically, as shown in Figure 1, while illuminating the patient's eye, the optical unit is angled diagonally upward toward the eye, with the eye fixed diagonally downward toward the optical unit, so that the path 92 is oblique. For example, the path can be angled at an angle θ between 5 and 20 degrees relative to the horizontal. Advantageously, this orientation reduces eye obstruction by the patient's upper eyelids and associated anatomical structures when the patient's head is leaning against a headrest.

[0078] In some embodiments, the oblique orientation of the path 92 is achieved by an optical unit mounted on a wedge 40 attached to an XYZ stage unit, as shown in Figure 1. That is, the optical unit is mounted to the XYZ stage unit via the wedge 40 (the wedge 40 is omitted in Figure 2).

[0079] Instead of tilting the optical unit, or in addition to that, the patient's head can be tilted backward to reduce eye occlusion.

[0080] The system 20 further comprises a monitor 42 configured to display an image of the eye acquired by a camera. The monitor 42 may be mounted on the optical unit 30 or placed in any other suitable location, such as on a surface 38 adjacent to the device 21. In some embodiments, the monitor 42 includes a touchscreen, through which the user enters commands into the system. Alternatively or additionally, the system 20 may be equipped with any other suitable input device that the user can use, such as a keyboard or mouse.

[0081] In some embodiments, the monitor 42 is directly connected to the controller 44 via wired or wireless communication. In other embodiments, the monitor 42 is connected to the controller 44 via an external processor, such as a processor belonging to a standard desktop computer.

[0082] In some embodiments, the controller 44 is located within the XYZ stage unit 32, as shown in Figure 2. In other embodiments, the controller 44 is located outside the XYZ stage unit. Alternatively or additionally, the controller may perform at least some of the functions described herein in cooperation with another external processor.

[0083] In some embodiments, an α2 agonist 29 (Figure 1) is administered to the eye 25 before irradiation of the eye. The α2 agonist 29 may include, for example, apraclonidine and / or brimonidine. Typically, the α2 agonist is administered to the eye by dropping an eye drop 35 containing the α2 agonist into the eye.

[0084] Following administration of the α2 agonist 29, the α2 agonist constricts the blood vessels in the eye. After sufficient vasoconstriction, the eye is irradiated with the treatment beam 52. Typically, because the blood vessels are sufficiently constricted, irradiation is performed less than 40 minutes after administration of the α2 agonist (e.g., less than 30, 20, 10, or 5 minutes).

[0085] In some embodiments, the α2 agonist is administered at least twice. First, the α2 agonist is administered to the eye (for example, about 45–60 minutes before the expected start time of radiotherapy) to reduce the possibility of increased intraocular pressure. Next, the same or a different α2 agonist is administered, typically less than 40 minutes (e.g., less than 30, 20, 10, or 5 minutes) before the expected start time. If sufficient contraction is not achieved after a predetermined time, the same or a different α2 agonist is administered. After a predetermined time (typically less than 40 minutes, such as less than 30, 20, 10, or 5 minutes), the treatment is carried out.

[0086] In some embodiments, the user of system 20 evaluates whether the blood vessels in the eye are sufficiently constricted without assistance from the controller 44.

[0087] In other embodiments, the controller 44 assists the user based on images acquired by the camera 54. Specifically, the controller calculates a contraction scale indicating the degree of vasoconstriction by processing the images. (In some embodiments, only the green and / or blue frames of the image are processed for this purpose.) In response to the contraction scale exceeding a predetermined threshold, the controller outputs an instruction that the vasoconstriction has been sufficiently induced by the α2 agonist. For example, the controller may display a message on the monitor 42 indicating that radiotherapy can be continued. (The message does not need to explicitly mention contraction.) In response to the instruction, the user can begin treatment. Alternatively, if the contraction scale does not exceed the threshold, the controller outputs an instruction that the same or a different α2 agonist should be administered.

[0088] In some embodiments, the contraction scale is based on the percentage of pixels that are within a predetermined distance from the limbus 86 of the eye (Figure 3) and whose gray level is greater than a predetermined threshold (e.g., 230). Alternatively or additionally, the contraction scale may be based on the number and / or density of detected vessels, the average or maximum width of detected vessels, and / or any other appropriate statistics. To detect vessels in the image, the controller may use any of the techniques described below with reference to Figure 4.

[0089] In some embodiments, at least some of the functions of the controller 44 may be performed by hardware such as one or more fixed-function or general-purpose integrated circuits, application-specific integrated circuits (ASICs), and / or field-programmable gate arrays (FPGAs), as described herein. Alternatively or additionally, the controller 44 may perform at least some of the functions described herein by executing software and / or firmware code. For example, the controller 44 may be embodied as a programmed processor, for example, including a central processing unit (CPU) and / or graphics processing unit (GPU). Program code and / or data, including software programs, may be loaded for execution and processing by the CPU and / or GPU. The program code and / or data may be downloaded to the controller in electronic form, for example, over a network. Alternatively or additionally, the program code and / or data may be provided and / or stored in a non-transient tangible medium such as magnetic, optical, or electronic memory. When such program code and / or data is provided to the controller, it generates a machine or dedicated computer configured to perform the tasks described herein.

[0090] In some embodiments, the controller includes a system-on-module (SOM) such as Varisite® DART-MX8M.

[0091] (Delimitation of the target area) Herein, we refer to Figure 3, which is a schematic diagram of a technique for defining a target region 84 on an eye 25 according to several embodiments of the present invention.

[0092] Typically, the camera 54 (Figure 2) acquires at least one image 70 of the eye 25 before eye treatment. In some embodiments, based on the image 70, the controller 44 defines the target region 84 such that the target region does not lie over any blood vessels 72 visible in the image. (However, the target region may still lie over blood vessels that are too small or too deep to be visible in the image.)

[0093] To define the target region, the controller first identifies multiple endpoints 76 within image 70. Each endpoint 76 is located on the end of a respective blood vessel 72. Each endpoint 76 is at a different angle φ relative to a reference point 74, located radially medial to the eye from the endpoint. Typically, for each angle, the end on which the endpoint resides is closer to the reference point 74 than the other ends of the blood vessel at that angle. (Typically, at least 50 endpoints 76 are identified, but for simplicity, Figure 3 shows only three endpoints 76.)

[0094] Following the identification of the endpoints, the controller defines target regions 84 between the reference point and the endpoints. (Typically, at least 50 target regions are identified, but for simplicity, Figure 3 shows only one target region.) For example, the controller can first define at least one treatment path 82 between the endpoints and the reference point, and then define the target regions such that each target region lies on the treatment path 82 (e.g., the center of each target region lies on the treatment path). Consecutive target regions can be spaced apart by any appropriate angle, such as 2 to 4 degrees. For example, in the case of a 360-degree treatment path, the controller can define a number of target regions between 90 and 180. (It should be noted that depending on the size and spacing angle of each target region, consecutive target regions may overlap.)

[0095] In some embodiments, the controller defines an endpoint and target region for each angle belonging to a predetermined set of angles. For angles where a vascular edge cannot be identified, the controller defines a composite endpoint at a predetermined distance from a reference point that does not actually exist on any vascular edge.

[0096] Typically, the treatment pathway is defined such that the shortest distance between any one of the endpoints and the treatment pathway is at least 0.1 mm, for example, between 0.1 mm and 1 mm, in order to provide sufficient distance between the target area and the blood vessel.

[0097] In some embodiments, in order to define a treatment path, the controller first defines at least one curve 78 passing through endpoint 76 using, for example, any suitable spline interpolation method known in the art. Subsequently, the controller offsets curve 78 toward a reference point by, for example, a distance between 0.001 mm and 1 mm to define an offset curve 80. The controller then defines a treatment path in response to the offset curve 80.

[0098] For example, at least a portion of the treatment path may be identical to at least a portion of the offset curve. Alternatively, the treatment path can be defined as the perimeter of a predetermined shape, such as an ellipse (e.g., a circle), which is inscribed within the offset curve and has any suitable center. For example, the treatment path can be defined as the perimeter of the maximum area of ​​a predetermined shape inscribed within the offset curve, or the maximum area of ​​a predetermined shape centered at the reference point 74. As yet another alternative, the treatment path may be defined as a closed curve inscribed within the offset curve and having the shape of the limbus 86 of the eye. As yet another alternative, the treatment path can be defined by smoothing the offset curve 80 and / or offsetting the offset curve toward the reference point.

[0099] In some cases, as shown in Figure 3, the patient's eyelid obscures a blood vessel within one or more angular ranges. In such cases, the controller typically defines multiple curves 78 (and thus multiple offset curves 80), each passing through a different exposed angular range. Subsequently, based on the offset curves, the controller can define a closed treatment path as described above. Nevertheless, the controller may refrain from defining a target region within a hidden angular range (along with a smaller angular range adjacent to the hidden range to provide a safety margin). For example, in the scenario shown in Figure 3, assuming the patient's upper eyelid 83 obscures a blood vessel within this angular range, the controller may refrain from defining any target region between φ1 and φ2.

[0100] In other cases, the density of endpoints within a particular range of angles may be below a predetermined threshold density required by the curve fitting algorithm used to define the curve 78, even though angles within this range are exposed. (Low density may result, for example, from the inability to identify a sufficient number of blood vessels due to the patient being in a vasoconstricted state.) In such cases, the controller can define auxiliary points on the limbus 86 within that angular range to achieve the threshold density. Subsequently, the controller can define the curve 78 such that the curve passes through the endpoints and auxiliary points.

[0101] Typically, following the demarcation of the target region, the controller overlays each marker indicating the target region onto the image 70. (Optionally, markers indicating the treatment pathway can also be overlaid on the image.) The controller can then allow the user to adjust any of the target regions as needed and indicate to the controller that the target region has been approved.

[0102] Alternatively or additionally, the controller can perform simulated irradiation of target areas. For example, the controller can transmit a control signal 39 to the aiming motor 61 (Figure 2) to sequentially direct the therapeutic laser to each of the target areas. The controller can then process the signal from the encoder 67 (Figure 2) to confirm that the laser is indeed directed to each target area. Alternatively or additionally, the controller can overlay markers indicating the position to which the laser is directed onto a live sequence of eye images so that the user can confirm the aiming (including confirming that any eye movements are taken into account). Alternatively or additionally, in embodiments in which the radiation source comprises a aiming laser, the controller can cause the aiming beam to be emitted sequentially to each of the target areas, as described in U.S. Patent Application Publication 2021 / 0267800, incorporated herein by reference. The controller can then confirm, by image processing, that the aiming beam hits each target area. Alternatively or additionally, the controller can display a live sequence of eye images in which the aiming beam is visible so that the user can confirm the aiming.

[0103] Following user approval of the target area and / or verification of aiming by the controller and / or user, the controller directs the therapeutic laser to irradiate the target area.

[0104] For further details regarding the demarcation of the target region 84, refer further to Figure 4, which is a flowchart of an algorithm 88 for demarcating the target region 84 according to some embodiments of the present invention.

[0105] According to algorithm 88, the controller first identifies the blood vessels in image 70 in the blood vessel identification step 90. To identify the blood vessels, the controller can use segmentation, edge detection, feature enhancement, pattern recognition, and / or any other suitable image processing techniques. Such techniques are described, for example, in Das, Abhijit, et al., "Scleral Recognition - Research," 2013, 2nd IAPR Asian Conference on Pattern Recognition, IEEE, 2013, and their disclosure is incorporated herein by reference.

[0106] Next, in the reference point definition step 91, the controller defines the reference point 74. For example, the controller can identify the iris 85 or pupil 87 of the eye (e.g., using color division) and then place the reference point 74. Alternatively, the controller can identify the limbus 86 (e.g., using edge detection or maximum gradient detection) and then place the reference point at the center of the iris 85 or pupil 87. Alternatively, while the image 70 is displayed on the display 41 (Figure 1), the user of the system 20 can indicate the desired position of the reference point using any suitable user interface (e.g., a mouse). In response, the controller can place the reference point at the desired position. The controller can further calculate and store the offset of this position from the center of the iris, the center of the pupil, the center of the limbus, or any other anatomical point identifiable by image processing.

[0107] Next, the controller iterates over multiple angles relative to the reference point. Each angle is selected in the angle selection step 94. Following the angle selection, the controller checks in the check step 96 whether there is an endpoint at the selected angle. (This check is based on the fact that the controller identified a vessel in the vessel identification step 90.) If yes, the controller marks the endpoint in the endpoint marking step 98. Once an endpoint is detected at the selected angle, the controller checks in another check step 100 whether there are any endpoints that have not yet been selected.

[0108] In general, the controller can select any suitable angle. For example, the controller can define 0° with respect to any axis (such as the horizontal axis as shown in Figure 3). Subsequently, during each i-th iteration of i = 1…M, the controller can select (i-1)*Δθ, where Δθ is 0.5°, 1°, or any other suitable value. M (the number of iterations) can be selected such that 360° is between (M-1)*Δθ and M*Δθ.

[0109] Following the endpoint marking, the controller defines curve 78 in curve definition step 102. Next, the controller offsets curve 78 toward the reference point in curve offset step 104. In treatment path definition step 106, the controller defines the treatment path based on the offset curve 80. Finally, the controller defines the target area in target area definition step 108. Typically, each target area is specified as an offset from reference point 74 or another suitable reference point. (The offset can be specified in radial or Cartesian coordinates.)

[0110] In an alternative embodiment, the controller displays the offset curve 80 to the user (by overlaying the offset curve on image 70, on another still image of the eye, or on a live stream of such images), but does not define the target region. Rather, while the controller displays the offset curve, it receives the definition of the target region from the user. For example, the user can define the target region by clicking the mouse button at the desired position in each target region. In response, the controller sequentially designates the target region for irradiation by the therapeutic laser 43 (Figure 2).

[0111] (Implementation of treatment) Herein, we refer to Figure 5, a flowchart of algorithm 110 for performing automated trabeculoplasty according to several embodiments of the present invention.

[0112] Algorithm 110 begins with a target area designation step 112, where the controller designates multiple target areas on the patient's eye to deliver different amounts of energy. Each energy amount may be the same, or one or more energy amounts may differ from the others.

[0113] For example, the controller can define the target area as described above with reference to Figure 3-4. Subsequently, in response to user confirmation of the target area (as described above with reference to Figure 3), the controller can specify the target area for irradiation.

[0114] Alternatively, target regions can be specified using any other technique. For example, as described with reference to Figure 3 of U.S. Patent Application Publication 2021 / 0267800, the user can pinpoint the location of target regions relative to a suitable reference area of ​​the eye, such as the limbus. In a specific example, the user can specify an elliptical path of target regions adjacent to the limbus by specifying the number of target regions and the distance from the limbus to which the center or edge of each target region is located. In response to this input, the controller can calculate the location of each target region and, following user approval, designate these regions for irradiation.

[0115] In some embodiments, following the designation of a target region, the controller searches at least a portion of the eye for radiation-sensitive anatomical features in the anatomical feature identification step 114. Such anatomical features may include, for example, blood vessels if they have not yet been identified during, for example, the blood vessel identification step 90 of algorithm 88 (Figure 4). Alternatively or additionally, such anatomical features may include areas affected by highly pigmented limbal regions, trachoma, focal pemphigoid, focal scleritis, focal burns or other injuries, or growths (e.g., pterygium, corneal pannus, senile arch, dermoidoma or other types of limbal tumors, or limbal palsy). Sensitive anatomical features can be identified using any suitable imaging technique as described above with reference to the blood vessel identification step 90.

[0116] In some embodiments, the search for sensitive anatomical features is limited to a predetermined distance (e.g., 1.5, 3, or 5 mm) from the therapeutic pathway 82 (Figure 3) or the limbus. In other embodiments, the entire eye is searched.

[0117] Next, the controller selects a first target region in the target region selection step 116. The controller then initiates an iterative processing process. Each iteration begins with an image processing step 117, where the controller processes one or more images of the eye. (As described in U.S. Patent Application Publication 2021 / 0267800, whose disclosure is incorporated herein by reference, the controller may flash a light on the eye while one or more of the images are being acquired.) In this regard, refer to Figure 6A, a flowchart of the image processing step 117 according to some embodiments of the present invention.

[0118] In some embodiments, the image processing step 117 begins with an image acquisition step 118 in which an image of the eye is acquired using a camera 54 (Figure 2).

[0119] Next, in the reference point identification step 119, the controller attempts to locate the reference point 74 (Figure 3) in the image. Once the reference point is located, in the position calculation step 120, the controller calculates the position of the selected target region based on the position of the reference point. For example, if the target region is defined as being at a displacement of (dx, dy) from the reference point, and for each image the reference point is at (x0, y0), the controller can calculate the position of the target region as (x0+dx, y0+dy). (Thus, the controller compensates for any eye movements following the target region designation step 112.) On the other hand, if the reference point cannot be found, the controller immediately proceeds to the determination step 128, which is described below.

[0120] Following the position calculation step 120, the controller begins aiming the therapeutic laser 43 (Figure 2) in the aiming start step 125 by communicating an appropriate control signal 39 to the aiming motor 61 (Figure 2) at the selected target area, i.e., the position calculated in the position calculation step 120. Subsequently, while the laser is being aimed, the controller checks in another check step 122 whether there are any static or dynamic obstructions at the location of the target area. Static obstructions that have a constant position relative to the eye may include, for example, growths such as any of the growth examples listed above, or blood vessels on the sclera, limbus, or cornea (e.g., neovascularization of the cornea). Dynamic obstructions that may change position relative to the eye during treatment may include, for example, eyelids, eyelashes, fingers, or speculum.

[0121] More generally, in the context of this application, including the claims, “obstacle” may be anything other than tissue that is considered irradiable by the user of the system. Therefore, the scope of the term “obstacle” may vary depending on the procedure. For example, in some treatments blood vessels constitute an obstacle, while in other treatments, irradiation of blood vessels may be permitted or even desired so that they do not become an obstacle.

[0122] In general, obstacles can be identified using any appropriate image processing technique, combined with user input as an option. For example, prior to a treatment procedure, the user may indicate one or more parts of the eye constituting a potential obstruction by identifying these parts in, for example, image 70 (Figure 3). Subsequently, in check step 122, the controller may identify selected parts of the eye using any other appropriate technique, including template matching, edge detection, or, for example, identification of changes between consecutive images. Such techniques can also be used to identify other static or dynamic obstructions that the user did not need to identify beforehand.

[0123] In some embodiments, the controller further inspects in inspection step 122 for obstacles that meet one or more predetermined criteria, even if the obstacles do not obstruct the selected target area. For example, the controller may check for obstacles whose size exceeds a predetermined threshold or obstacles that are moving toward the selected target area.

[0124] If an obstacle is identified, the controller immediately proceeds to determination step 128, where it may determine whether to refrain from irradiating the target area with the radiation source. Otherwise, in another check step 124, the controller checks whether the selected target area is too sensitive to be irradiated with the specified amount of energy, as described below with reference to Figure 7. Otherwise, in another check step 127, the controller checks whether the laser is properly directed, i.e., whether the laser is directed to the location of the target area. For example, the controller may process the feedback signal 37 from the encoder 67 (Figure 2).

[0125] If the laser aiming is inappropriate, the controller immediately proceeds to determination step 128. Otherwise, in some embodiments, the controller performs one or more final verifications in verification step 135. For example, as described in U.S. Patent Application Publication 2021 / 0267800, whose disclosure is incorporated herein by reference, the controller may verify that the target area is not (even partially) within a “forbidden area.” A “forbidden area” is a static area within the camera’s field of view (FOV) to which illumination is prohibited for safety reasons. Alternatively or additionally, as further described in U.S. Patent Application Publication 2021 / 0267800, the controller may verify that the target area is within a predetermined distance from a previous target area, indicating that the eye is relatively stationary. Following the performance of verification step 135, the controller performs determination step 128.

[0126] In the determination step 128, the controller determines whether to illuminate the target area selected in response to the processing of the eye image in the image processing step 117. The controller may decide to illuminate the selected target area if, for example, the reference point is identifiable, no obstacles are identified, the selected target area is not overly sensitive, the laser is properly directed, and the verification step 135 has been successfully performed.

[0127] Following the irradiation decision, in irradiation step 130, the treatment beam is irradiated onto the target area. Next, in another check step 132, the controller checks if there are any target areas that have not yet been selected. If so, the controller selects the next target area in another target area selection step 133 and starts the next iteration of treatment by returning to the image processing step 117. Otherwise, the treatment process ends.

[0128] On the other hand, if the controller decides not to irradiate the selected area, the controller starts heating the laser medium 45 in the heating start step 129, for example, by communicating an appropriate control signal 55 to the driver 53 (Figure 2). (As will be further explained below with reference to Figure 9, the laser medium does not oscillate in response to heating.) Subsequently, while the laser medium is heating, the controller decides in another decision step 131 whether to skip the selected target area. That is, to refrain from irradiating the selected target area in subsequent iterations as well. The controller may decide to skip the selected target area, for example, if an obstacle is identified at the location of the target area, or if the target area is too sensitive.

[0129] If the controller determines that it will skip the target region, it proceeds to check step 132. Otherwise, in another determination step 137, the controller determines whether to shift the selected target region. The controller may decide to shift the selected target region, for example, if an obstacle is identified at the location of the target region, or if the current location of the target region is too sensitive to irradiation.

[0130] If the controller determines, for example, to shift the target region to avoid an identified obstacle, the controller shifts the target region in the target region shift step 126 (typically the target region is shifted away from the pupil). The controller then returns to the image processing step 117. Thus, during subsequent iterations, the controller can cause the radiation source to irradiate a different location in the target region instead of its original location.

[0131] On the other hand, if the controller determines that the target region does not need to be shifted, the controller immediately returns to the image processing step 117. Therefore, the original position of the target region can be irradiated during subsequent iterations.

[0132] In other embodiments, if an obstacle is identified, or if the target area is too sensitive to be irradiated with a specified amount of energy, the controller may, after performing the aiming start step 125, check step 127, and verification step 135, determine to irradiate the target area with less energy than the specified amount. To control the energy of the treatment beam 52, the controller may control the amount of energy delivered to the laser medium 45 (Figure 2).

[0133] Alternatively, if an obstacle is identified, or if the target area is too sensitive, the controller can terminate the treatment procedure entirely.

[0134] In some embodiments, for greater efficiency, the calculation step 120 and the aiming start step 125 are performed before the reference point identification step 119, based on the position of the reference point during the previous iteration. In such embodiments, after identifying the position of the reference point, the controller checks that the reference point has not moved beyond a predetermined threshold amount. Provided that the reference point has not moved beyond the threshold amount, the controller performs the subsequent steps of the image processing step 117.

[0135] Here, we refer to Figure 6B, a flowchart of the image processing step 117 according to another embodiment of the present invention.

[0136] As described above with reference to Figure 2, in some embodiments the optical unit 30 includes a aiming laser. In such embodiments, following the aiming of both lasers to the calculated position of the target area, the controller causes the aiming laser to emit a aiming beam. The controller then processes an image of the eye to identify the position of the aiming beam over the eye and calculates the deviation between this position and the calculated position of the target area. Based on the deviation, the controller can then determine that the therapeutic laser is improperly aimed. For example, the controller can determine that the therapeutic laser is improperly aimed in response to a deviation exceeding a predetermined threshold.

[0137] For example, as shown in Figure 6B, in some embodiments, after calculating the position of the selected target area in calculation step 120, the controller initiates aiming of the aiming laser and the treatment laser in another aiming start step 162. (As assumed in Figure 6B, the calculation may be based on the position of a reference point during a previous iteration.) Following laser aiming, the controller causes the aiming laser to emit a aiming beam in firing step 164. (Alternatively, the aiming beam may be emitted continuously during treatment.) In some embodiments, the wavelength of the aiming beam is greater than 700 nm (i.e., the aiming beam is infrared), so the aiming beam is invisible and therefore does not disturb the patient.

[0138] Next, the controller acquires at least one image of the eye. For example, as assumed in Figure 6B, the controller can acquire a single image that includes a first frame in which the aiming beam appears and a second frame in which the aiming beam does not appear, while the aiming beam is being emitted. For example, camera 54 (Figure 2) may include a filter matrix (or “filter array”) configured to filter the aiming beam from the second frame. For example, in embodiments where the wavelength of the aiming beam is greater than 700 nm, the filter matrix may exclude wavelengths greater than 700 nm. Alternatively, the wavelength of the aiming beam may be selected so that a standard Bayer filter excludes the aiming beam from the second frame. For example, the aiming beam may be red so that it is visible in the first (red) frame of the image but not in the second (green) frame of the image.

[0139] Next, in the aiming beam position determination step 166, the controller attempts to determine the position of the aiming beam within the first frame of the image. If the position of the aiming beam cannot be determined, the controller immediately proceeds to the determination step 128. Otherwise, in the reference point position determination step 168, the controller attempts to determine the position of the reference point within the second frame of the image. If the position of the reference point cannot be determined, the controller immediately proceeds to the determination step 128. Otherwise, the controller proceeds to the check step 127, where the controller checks whether (i) the aiming beam collides with the calculated position in the target area, and (ii) whether the deviation between the current position of the reference point and the position of the reference point in the previous iteration is less than a predetermined threshold. Otherwise, the controller immediately proceeds to the determination step 128. If so, the controller performs the check step 122, the check step 124, and the verification step 135.

[0140] In other embodiments, the controller acquires two images of the eye: a first image is acquired while the aiming beam is being emitted, and the aiming beam appears in the first image (as described above). A second image is acquired before or after the aiming beam is emitted, and the aiming beam does not appear in the second eye image. For example, after acquiring the first image, the controller may turn off the aiming beam and then acquire the second image. The controller may then attempt to locate the aiming beam in the first image in the aiming beam locating step 166, and attempt to locate the reference point in the second image in the reference point locating step 168.

[0141] In yet another embodiment, the controller acquires a single image and identifies the positions of the aiming beam and reference point within the same frame of the image.

[0142] Herein, we refer to Figure 7, a flowchart for check step 124 according to some embodiments of the present invention.

[0143] Check step 124 begins with the initial evaluation step 134. In this step, the controller processes the most recent acquired image, usually along with previously acquired images, to check if any problematic changes have occurred in the eye—such as bleeding, swelling, changes in identifiable vascular density, formation of one or more bubbles, and / or changes in color. If no such changes are identified, the controller determines that the selected target area is not overly sensitive to irradiation. Otherwise, the controller may determine that the selected target area is overly sensitive to irradiation, which will be further explained below.

[0144] When performing the first evaluation step 134, the controller may use any appropriate image processing techniques, including, for example, optical flow, pattern recognition, edge detection, segmentation, difference checking, and / or color monitoring. For example, the controller may use pattern recognition to facilitate alignment and align the most recent image with a previously acquired image (such as an image acquired before the treatment procedure). Subsequently, the controller may subtract the previously acquired image from the current image and use edge detection or segmentation to identify the location of target features in the difference image, such as color changes or other features indicating bleeding or swelling.

[0145] In response to the identification of a problematic change, the controller, in a second evaluation step 136, verifies whether a sensitive anatomical feature (identified in the anatomical feature identification step 114 in Figure 5) is located in a selected target region. In the context of this application as defined in the claims, an anatomical feature is said to be located in the target region if any portion of the anatomical feature is within a predetermined threshold distance of the target region. The threshold distance is typically defined automatically or semi-automatically based on (i) the maximum possible eye movement between the image acquisition step 118 (Figures 6A-B) and the irradiation step 130 (Figure 5), and (ii) the calibration accuracy of the laser. In some embodiments, the predetermined threshold distance is less than 3 mm.

[0146] In response to sensitive anatomical features being located in the selected target region, the controller calculates a predictive overlap measure between the therapeutic beam irradiating the selected target region and the anatomical feature in overlap prediction step 138. The predictive overlap measure can be expressed, for example, as the amount of area of ​​the anatomical feature over which the beam is predicted to overlap.

[0147] When calculating the overlap predictive measure, the controller may assume that the treatment beam does not deviate from the target area. Alternatively, prior to the procedure, the controller may calculate the probability distribution of the treatment beam deviation from the target area, and / or one or more statistics of this distribution, such as the maximum deviation, mean deviation, and median deviation. Subsequently, the controller may calculate the overlap predictive measure based on the statistics, for example, by assuming that the treatment beam deviates towards the anatomical feature by the maximum, mean, or median deviation.

[0148] Subsequently, or if no sensitive anatomical features are present in the selected target region, the controller determines in the third evaluation step 140 whether the changes identified in the first evaluation step 134 are likely due to irradiation of a sensitive anatomical feature in any one of the irradiated target regions. For example, the controller may check whether any portion of the image showing the change is within a predetermined threshold distance of such a sensitive anatomical feature.

[0149] If the change is likely to be due to irradiation of a sensitive anatomical feature, the controller calculates an estimated overlap scale between the treatment beam irradiating the target area and the anatomical feature in overlap estimation step 142. The overlap estimate scale can be expressed, for example, as the amount of area of ​​the anatomical feature over which the beam is estimated to have overlapped. Following the calculation of the overlap estimate scale, or if the change is likely not due to irradiation of a sensitive anatomical feature, the controller performs the risk scale calculation step 144 described below.

[0150] In some embodiments, the controller estimates the overlap scale based on the position of the targeting beam identified in the targeting beam positioning step 166 (Figure 6B). For example, the controller may assume that the treatment beam collided with (i) the position of the targeting beam in an image acquired immediately before the treatment beam was fired, or (ii) the position of the targeting beam in an image acquired immediately after the treatment beam was fired. Alternatively, the controller may calculate the average of (i) and (ii) and assume that the treatment beam hit the eye at this average position.

[0151] Alternatively, in embodiments where no targeting beam is emitted, the controller can estimate the measure of overlap based on the position to which the therapeutic laser is directed (as indicated by a feedback signal from the encoder), along with the estimated spot size of the therapeutic beam to the eye.

[0152] In addition to estimating and predicting the overlap scale, the controller can calculate an estimate of the energy delivered (by the therapeutic beam) to sensitive anatomical features in the irradiated target region, along with a predictive amount of energy delivered (by the therapeutic beam) to sensitive anatomical features in the selected target region. Typically, the delivered energy estimate or predictive amount is a function of the overlap estimation or prediction scale (respectively) along with parameters that vary with the setup of System 20 (Figure 1), such as the therapeutic beam energy and spot size.

[0153] In risk scale calculation step 144, the controller calculates a risk scale associated with irradiation of the selected target region. Typically, the risk scale is higher when sensitive anatomical features are present in the selected target region compared to when sensitive anatomical features are not present in the selected target region. Furthermore, assuming that a higher scale of overlap or delivered energy is more likely to cause further changes in the eye, the risk scale is an increasing function of the predictor in the selected target region. Conversely, if the identified changes are usually less likely to be due to irradiation of sensitive anatomical features, the risk scale is higher and is a decreasing function of the estimator. Thus, for example, the risk scale can be an increasing function of the ratio of the predictor to the estimator.

[0154] Alternatively or additionally, risk scales may be based on aspects of a patient's medical profile, particularly those related to the patient's eye sensitivity. For example, risk scales may be based on parameters such as the patient's age, sex, medication history (especially regarding the use of topical ophthalmic medications), frequency of contact lens use, and / or intraocular pressure. Therefore, for example, a patient with a history of using topical ophthalmic medications may be given a higher risk scale than another patient without such a history.

[0155] Alternatively or additionally, risk measures can be based on the type of anatomical features in the selected target region. For example, it is empirically known that larger blood vessels are more likely to bleed than smaller blood vessels. Therefore, the risk measure will be higher for the former than for the latter.

[0156] Alternatively or additionally, the risk measure may be an increasing function of the similarity between the anatomical features in the selected target region and the irradiated anatomical features identified in the third assessment step 140. Similarity may include, for example, similarity in type, color, and / or size.

[0157] Alternatively or additionally, the risk scale may be based on the type of change identified. For example, a risk scale may be higher in response to the detection of bleeding or swelling compared to simply detecting a change in color.

[0158] Following the calculation of the risk scale, the controller compares the risk scale to a predetermined threshold in the fourth evaluation step 146. If the risk scale exceeds the threshold, the controller determines that the selected target area is too sensitive to irradiation. Accordingly, the controller may refrain from irradiating the target area, or at least reduce the energy to which the target area is irradiated, as described above with reference to Figure 5.

[0159] If one or more identified changes are likely caused by irradiation of multiple sensitive anatomical features, the controller will consider each of these anatomical features when assessing the risk of the selected target region. For example, the risk scale may be based on the type of each sensitive anatomical feature and / or the respective estimation scale of the overlap of the sensitive anatomical features.

[0160] Please note that the flowchart in Figure 7 is presented as an example only, and many other embodiments of check step 124 are included within the scope of the present invention.

[0161] for example: (i) Instead of, or in addition to, confirming whether the selected target region has sensitive anatomical features, the controller confirms whether the selected target region is within a predetermined threshold distance from sensitive areas of the eye, such as the pupil or a cluster of blood vessels. If so, the risk measure can optionally be increased as a function of the distance between the target region and the sensitive areas.

[0162] (ii) In response to the identification of a problematic change, the controller may acquire and process additional images before proceeding to the remaining verification step 124. Processing of additional images will enable the controller to verify the change, identify its type, and / or monitor the change for safety purposes. Thus, for example, if bleeding does not stop within a predetermined time or if the area covered by blood exceeds a predetermined threshold, the treatment procedure may be terminated.

[0163] (iii) The control device may determine that the selected target area is too sensitive to irradiation without calculating a risk scale. For example, such a determination may be made immediately after the presence of sensitive anatomical features is confirmed in the second evaluation step 136. Alternatively, such a determination may be made in response to a predicted overlap scale or predicted delivery amount. This may be an absolute number or a number derived from the corresponding estimate of the irradiation target area identified in the third evaluation step 140. Alternatively, such a determination may be made in response to the selected target area and the irradiated anatomical feature being of the same type.

[0164] Here, we refer to Figure 8, which shows examples of check step 124 (Figures 6A-B) and target region shift step 126 (Figure 5) according to some embodiments of the present invention.

[0165] Figure 8 shows image 148 of eye 25 acquired in image acquisition step 118 (Figures 6A-B). By processing image 148 as described above with respect to the first evaluation step 134 (Figure 7) of check step 124, the controller can identify blood pool 150 near the irradiated target area 84a. Blood pool 150 indicates that irradiation of target area 84a likely caused bleeding of the first blood vessel 72a located in target area 84a. Therefore, before irradiating another target area 84b, the controller can move target area 84b away from the second blood vessel 72b, thus reducing the likelihood of another bleeding incident.

[0166] (Heating pulse) Refer again to Figure 2, and also to Figure 9, which is a schematic diagram of the timelines of the laser oscillation generation pulse 152 and heating pulse 154 according to some embodiments of the present invention.

[0167] Typically, before initiating irradiation of the target area (for example, according to algorithm 110 in Figure 5), the controller 44 (for example, by controlling the driver 53) causes the pump source 47 to heat the laser medium 45 without causing the laser medium to oscillate. For example, the controller may cause the pump source to pump the laser medium with a series 156 of one or more heating pulses 154, which are further described below. As a result of this heating, the laser medium can reach thermal equilibrium before emitting the therapeutic beam.

[0168] To initiate irradiation of the target area, the controller drives a pump source (for example, by controlling the driver 53) to start pumping the laser medium 45 with a series 158 of laser oscillation generation pulses 152. Generally, the series 158 is periodic with a duration T, i.e., each laser oscillation generation pulse 152 (except for the laser oscillation generation pulse following the heating pulse 154) occurs at an interval of T from the preceding laser oscillation generation pulse. Each laser oscillation generation pulse 152 causes the laser medium to oscillate and thus emits a therapeutic beam 52 near the end of the pulse, as shown in Figure 9 by the laser oscillation marker 160. (Irradiation step 130 in Figure 5 includes pumping the laser medium with pulses that cause laser oscillation and emitting the therapeutic beam.)

[0169] Following the start of irradiation of the target area, the controller may cause the pump source to substitute one of the laser oscillation generation pulses with one or more heating pulses 154. Each heating pulse 154 is configured to heat the laser medium without causing the laser medium to oscillate.

[0170] For example, as described above with reference to Figures 5 and 6-9, referring to Figures 6A-B, the controller processes one or more images of the eye acquired by the camera 54 (e.g., in the image acquisition step 118) and can cause the pump source to be replaced with a heating pulse in response to the image processing. For example, the controller can cause the pump source to be replaced with a heating pulse in response to the identification of eye occlusion (in step 122), the identification of changes in the eye (in the check step 124), or confirmation that the therapeutic laser is not directed to the location of the target area to be irradiated (in the check step 127). Alternatively, the controller may cause the pump source to be replaced with a heating pulse in response to a signal indicating an error. For example, a feedback signal 37 (Figure 2) may indicate that the beam guidance element is not oriented as expected, or another signal may indicate a malfunction of the therapeutic laser or other components of the optical unit.

[0171] Typically, the total energy E2 of the heating pulse that replaces the laser oscillation generation pulse is approximately equal to the energy E0 of the laser oscillation generation pulse minus the energy E1 lost by the laser medium during laser oscillation. Therefore, thermal equilibrium of the laser medium is maintained. Typically, E1 is 0-30% of E0, and E2 is 70-100% of E0.

[0172] For example, the pump source can be replaced with a single heating pulse that spreads the energy E2 over a sufficiently long duration so as not to reach the laser threshold of the laser medium.

[0173] Alternatively, the pump source can be replaced by heating pulses with N>1. For example, assuming that the duration of each laser oscillation generation pulse is D0 (where D0 is, for example, between 120 and 150 microseconds), each heating pulse may have a duration of D0 but a lower average power than each laser oscillation generation pulse, and the energy of the heating pulse will be E2 / N. Alternatively, each heating pulse may have a duration of D0 / N. For example, each heating pulse may have a duration of D0 / N and a peak power equal to the peak power of each laser oscillation pulse. As a concrete example, assuming that the instantaneous power of each laser oscillation generation pulse is approximately constant at P0 = E0 / D0, the duration of each heating pulse is D0 / N, and the instantaneous power is approximately constant at P0, as shown in Figure 9 for the case N=2.

[0174] Typically, the heating pulse is replaced by a time {k*T / N}, k=0…N-1, from time t0 to time {k*T / N}, where the pulse that causes the laser oscillation should have been pumped. For example, as shown in Figure 9 for N=2, the first heating pulse can start at t0 and the second heating pulse can start at t0+T / 2.

[0175] While the above description primarily relates to trabeculoplasty, it should be noted that embodiments of the present invention can be applied to any type of surgical procedure in which a target area of ​​the eye is irradiated, such as transscleral ciliary body photocoagulation (TSCPC) or tissue contraction.

[0176] Those skilled in the art will understand that the present invention is not limited to those specifically shown and described above. Rather, the scope of embodiments of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not in the prior art and would be recalled by those skilled in the art having read the foregoing description. Documents incorporated into this patent application by reference are considered integral parts of the application. In the event of any conflict between definitions made expressly or implicitly herein and definitions in such documents, the definitions herein should take precedence.

Claims

1. It is a system: Having a radiation source; a controller; The aforementioned controller is: To deliver each amount of energy, multiple target areas on the patient's eye are designated. The radiation source is made to irradiate at least the first target region of the plurality of target regions. After irradiating at least the first target region of the plurality of target regions with the radiation source, the changes in the eye are identified by processing the image of the eye. In response to the identification of the aforementioned change in the eye, the radiation source is instructed to refrain from irradiating a second target region among the plurality of target regions that has not yet been irradiated with the energy amount specified for the second target region. It is configured in such a way. A system characterized by the following features.

2. The system according to claim 1, characterized in that the controller specifies a new target region and causes the radiation source to irradiate the new target region instead of the second target region.

3. The system according to claim 1, characterized in that the controller causes the radiation source to irradiate the second target region with a different energy amount that is less than the energy amount specified for the second target region among the plurality of target regions, thereby refraining from irradiating the second target region with the energy amount specified for the second target region.

4. The system according to claim 1, characterized in that the aforementioned change includes bleeding.

5. The system according to claim 1, characterized in that the aforementioned change includes expansion.

6. The system according to claim 1, characterized in that the aforementioned change includes a change in color.

7. The system according to claim 1, characterized in that the change includes the formation of one or more bubbles.

8. The system according to claim 1, characterized in that the controller is configured to refrain from irradiating the second target region with the radiation source in response to the distance between the second target region and another region of the eye.

9. The system according to any one of claims 1 to 8, wherein the controller is further configured to identify anatomical features in the second target region, and the controller is configured to refrain from irradiating the second target region with the radiation source in response to the identification of the anatomical features.

10. The controller is further configured to calculate a predictive measure of the overlap between the radiation beam irradiating the second target region and the anatomical features, The system according to claim 9, characterized in that the controller is configured to refrain from irradiating the second target region with the radiation source in response to the predicted overlap scale.

11. The aforementioned anatomical features are the anatomical features of the second target region, The controller is further configured to identify anatomical features of the first target region in the first target region, The system according to claim 9, characterized in that the controller is configured to refrain from irradiating the second target region with a radiation source in response to the identification of anatomical features of the first target region.

12. The system according to claim 11, characterized in that the controller is configured to refrain from irradiating the second target region with the radiation source in response to the anatomical features of the first target region and the anatomical features of the second target region being of the same type.

13. The controller further, (a) Calculate an estimated overlap between the first radiation beam that irradiated the first target region and (b) the anatomical features of the first target region. (a) Calculate a predictive measure of the overlap between the second radiation beam that irradiates the second target region and (b) the anatomical features of the first target region. It is configured in such a way, The system according to claim 11, wherein the controller is configured to refrain from irradiating the second target region with the radiation source in response to the prediction scale of the overlap and the estimation scale of the overlap.

14. The controller further, The estimated amount of energy delivered to the anatomical features of the first target region by the first radiation beam is calculated, and The predicted amount of energy delivered to the anatomical features of the second target region by the second radiation beam is calculated. It is configured in such a way, The system according to claim 13, characterized in that the controller is configured to refrain from irradiating the second target region with the radiation source in response to the estimated energy amount and the predicted energy amount.

15. The controller is further configured to calculate a risk scale associated with irradiating the second target region. The system according to any one of claims 1 to 8, characterized in that the controller is configured to refrain from irradiating the second target region with the radiation source in response to the risk scale.

16. The system according to claim 15, wherein the controller is configured to calculate the risk scale based on the patient's medical profile.

17. The controller is further configured to identify anatomical features in the second target region. The system according to claim 15, wherein the controller is configured to calculate a risk scale based on the type of anatomical features of the second target region.

18. Method: The steps include: specifying multiple target areas on the patient's eye to irradiate with different amounts of energy; The steps include: irradiating at least a first region of the target region with the radiation source; The steps include: irradiating at least a first region of the target region with a radiation source, followed by processing an image of the eye to identify changes in the eye; and The steps include: in response to the identification of the aforementioned change in the eye, causing the radiation source to refrain from irradiating a second target region that has not yet been irradiated with the amount of energy specified for the second target region; A method characterized by having the following:

19. The step of refraining from irradiating the second target region with the radiation source is: The steps include specifying a new target region; and The steps include: causing the radiation source to irradiate the new target region instead of the second target region; The method according to 18, characterized by having the following:

20. The method according to 18, characterized in that the step of causing the radiation source to refrain from irradiating the second target region with an amount of energy specified for the second target region comprises the step of causing the radiation source to irradiate the second target region with a different amount of energy that is less than the amount specified for the second target region.

21. The method according to 18, characterized in that the change includes bleeding.

22. The method according to 18, characterized in that the change includes expansion.

23. The method according to 18, characterized in that the change includes a change in color.

24. The method according to 18, characterized in that the change includes the formation of one or more bubbles.

25. The method according to 18, characterized in that the step of refraining from irradiating the second target region with the radiation source is to refrain from irradiating the second target region with the radiation source in response to the distance between the second target region and another region of the eye.

26. The method further comprises the step of identifying anatomical features in the second target region, The method according to any one of claims 18 to 25, characterized in that the step of refraining from irradiating the second target region with the radiation source is a step of refraining from irradiating the second target region with the radiation source in response to the identification of anatomical features in the second target region.

27. The method according to 26, further comprising the step of calculating a predictive scale of overlap between a radiation beam irradiating the second target region and the anatomical features, wherein the step of causing the radiation source to refrain from irradiating the second target region is characterized in that the radiation source refrains from irradiating the second target region in response to the predictive scale of overlap.

28. The aforementioned anatomical features are the anatomical features of the second target region, The method further includes the step of identifying the anatomical features of the first target region, The method according to 26, characterized in that the step of refraining from irradiating the second target region with the radiation source includes the step of refraining from irradiating the second target region with the radiation source in response to the step of identifying the anatomical features of the first target region.

29. The method according to 28, characterized in that the step of refraining from irradiating the second target region with the radiation source includes the step of refraining from irradiating the second target region with the radiation source in response that the anatomical features of the first target region and the anatomical features of the second target region are of the same type.

30. (a) a step of calculating an estimated measure of the overlap between a first radiation beam that irradiates the first target region and (b) the anatomical features of the first target region; and (a) a second radiation beam irradiating the second target region and (b) a step of calculating a predictive measure of the overlap between the anatomical features of the first target region; It has, The method according to 28, characterized in that the step of refraining from irradiating the second target region with the radiation source includes the step of refraining from irradiating the second target region with the radiation source in response to the overlap prediction scale and the overlap estimation scale.

31. The steps include: calculating an estimate of the energy delivered to the anatomical features of the first target region by the first radiation beam; and The predicted amount of energy delivered to the anatomical features of the second target region by the second radiation beam is calculated. The method according to 30, characterized in that the step of refraining from irradiating the second target region with the radiation source includes the step of refraining from irradiating the second target region with the radiation source in response to the predicted amount of energy and the estimated amount of energy.

32. The method according to any one of claims 18-25, further comprising the step of calculating a risk scale related to irradiating the second target region, wherein the step of refraining from irradiating the second target region with respect to the radiation source comprises the step of refraining from irradiating the second target region with respect to the radiation source in response to the risk scale.

33. The method according to 32, characterized in that the step of calculating the risk scale includes the step of calculating the risk scale based on the patient's medical profile.

34. The method further comprises the step of identifying anatomical features in the second target region, The method according to 32, characterized in that the step of calculating the risk scale includes the step of calculating the risk scale based on the type of anatomical features in the second target region.

35. It is a system: It comprises a radiation source and a controller, The aforementioned controller is: Acquire an image of the eye, In the aforementioned image, multiple endpoints are identified at different angles with respect to a reference point, where the reference point is located above the eye radially inward from the endpoints, and each of the endpoints is located at the end of its respective blood vessel. A plurality of target regions above the eye are defined between the aforementioned reference point and the aforementioned endpoint. The radiation source is used to irradiate the target region. A system characterized by being configured in such a way.

36. The system according to claim 35, characterized in that the reference point is located at the center of the iris of the eye.

37. The system according to claim 35, characterized in that the reference point is located at the center of the limbus of the cornea of ​​the eye.

38. The system according to claim 35, characterized in that the reference point is located at the center of the pupil of the eye.

39. The system according to claim 35, characterized in that, for each of the aforementioned angles, the end of each blood vessel is closer to the reference point than the other ends of the blood vessel at that angle.

40. The aforementioned controller is: The steps include: defining at least one treatment path between the endpoint and the reference point; and defining the target region such that each of the target regions lies on the treatment path; The system according to any one of claims 35-39, characterized in that it is configured to define the target region by

41. The system according to claim 40, characterized in that the controller is configured to define the treatment path such that the shortest distance between any one of the endpoints and the treatment path is at least 0.001 mm.

42. The aforementioned controller, Define at least one curve passing through the aforementioned endpoints, The curve is offset toward the reference point, The system according to claim 40, characterized in that it defines the treatment path in response to the offset curve.

43. The system according to claim 42, wherein the controller is configured to define the treatment path in response to the offset curve by defining the treatment path as the perimeter of a predetermined shape inscribed in the offset curve.

44. The system according to claim 43, characterized in that the predetermined shape is an ellipse.

45. The system according to claim 42, wherein the controller is configured to define the treatment path in response to the offset curve by defining the treatment path as the perimeter of a predetermined shape having the largest area inscribed in the offset curve.

46. The system according to claim 42, characterized in that the controller is configured to define the treatment path in response to the offset curve by defining the treatment path as the perimeter of a predetermined shape having the largest area inscribed in the offset curve, with the reference point as the center.

47. The system according to claim 42, characterized in that the controller is configured to define the treatment path in response to the offset curve by defining the treatment path as a closed curve that is inscribed in the offset curve and has the shape of the limbus of the eye's cornea.

48. Method: Steps to obtain an image of the eye; The steps include: identifying a plurality of endpoints in the aforementioned image at different angles with respect to a reference point, wherein the reference point is located above the eye radially inward from the endpoints, and each of the endpoints is located above the end of the respective blood vessel; The steps include defining a plurality of target regions on the eye between the reference point and the endpoint; and The steps include: causing the radiation source to irradiate the target region; A method characterized by having the following:

49. The method according to 48, characterized in that the reference point is located at the center of the iris of the eye.

50. The method according to 48, characterized in that the reference point is located at the center of the limbus of the cornea of ​​the eye.

51. The method according to 48, characterized in that the reference point is located at the center of the pupil of the eye.

52. The method according to 48, characterized in that, for each of the angles, the end of each of the blood vessels is closer to the reference point than any other end of any blood vessel at that angle.

53. The step of defining the target region is: The steps include defining at least one treatment pathway between the endpoint and the reference point; and The steps include defining the target regions such that each of the target regions lies on the therapeutic pathway; The method according to any one of claims 48-52, characterized by having the following:

54. The method according to 53, characterized in that the step of defining the treatment path comprises defining the treatment path such that the shortest distance between any one of the endpoints and the treatment path is at least 0.001 mm.

55. The step of defining the aforementioned treatment pathway is: The steps include defining at least one curve passing through the aforementioned endpoints; The steps include: offsetting the curve toward the reference point; and The steps include defining the treatment pathway in response to the offset curve; The method according to 53, characterized by having the following:

56. The method according to 55, characterized in that the step of defining the treatment path in response to the offset curve comprises the step of defining the treatment path as the perimeter of a predetermined shape inscribed in the offset curve.

57. The method according to claim 56, wherein the predetermined shape is an ellipse.

58. The method according to 55, characterized in that the step of defining the treatment path in response to the offset curve comprises the step of defining the treatment path as the perimeter of a predetermined shape having the largest area inscribed in the offset curve.

59. The method according to 55, characterized in that the step of defining the treatment path in response to the offset curve comprises the step of defining the treatment path as the perimeter of a predetermined shape having the largest area centered on the reference point and inscribed in the offset curve.

60. The method according to 55, characterized in that the step of defining the treatment path in response to the offset curve comprises the step of defining the treatment path as a closed curve inscribed in the offset curve and having the shape of the limbus of the eye.

61. It is a system: Having a radiation source; a controller; The aforementioned controller is: Acquire an image of the eye, In the aforementioned image, multiple endpoints are identified at different angles with respect to a reference point, where the reference point is located above the eye radially inward from the endpoints, and each of the endpoints is located at the end of its respective blood vessel. Define at least one curve passing through the aforementioned endpoints, The curve is offset toward the aforementioned reference point, While displaying the offset curve to the user, the system receives definitions of multiple target regions of the eye from the user, and To cause the radiation source to irradiate the target region, It is configured in such a way. A system characterized by the following features.

62. Method: Steps to obtain an image of the eye; Steps include: identifying a plurality of endpoints in the aforementioned image at different angles with respect to a reference point, wherein the reference point is located above the eye radially inward from the endpoints, and each of the endpoints is at the end of its respective blood vessel; The steps include defining at least one curve passing through the aforementioned endpoints; A step of offsetting the curve toward the aforementioned reference point; The steps include: displaying the offset curve to the user while receiving definitions of multiple target regions of the eye from the user; and The steps include: causing the radiation source to irradiate the target region; A method characterized by having the following:

63. Method: The steps include administering an α2 agonist to the patient's eye; and The step of treating the patient's eye with laser irradiation within 40 minutes after administration of the α2 agonist; A method characterized by having the following:

64. The method according to 63, characterized in that the step of treating the patient's eye comprises the step of treating the patient's eye by irradiating the trabecular network of the eye with laser radiation.

65. The method according to 63 or 64, characterized in that the step of treating the patient's eye comprises the step of treating the patient's eye within 30 minutes after administration of the α2 agonist.

66. The method according to 63 or 64, characterized in that the step of treating the patient's eye is the step of treating the patient's eye in response to an instruction from a controller that the blood vessels of the eye have been sufficiently constricted by the α2 agonist.

67. An α2 agonist for use in a method of constricting a patient's eye, characterized in that the α2 agonist is administered to the patient within 40 minutes of treating the eye with laser irradiation.

68. The α2 agonist according to claim 67, characterized in that the step of treating the eye comprises the step of treating the eye by irradiating the trabecular meshwork of the eye with laser radiation.

69. The α2 agonist according to either 67 or 68, characterized in that the α2 agonist is administered to the patient less than 30 minutes before treating the eye with laser radiation.

70. It is a system: It comprises a camera configured to acquire an image of the patient's eye before eye treatment with laser radiation, and a controller; The aforementioned controller is: By processing the aforementioned images, a contraction scale is calculated that indicates the degree to which the blood vessels of the eye are constricted by the α2 agonist, and In response to a contraction scale exceeding a pre-set threshold, an indicator is output that the blood vessel has been sufficiently contracted by the α2 agonist. It is configured in such a way. A system characterized by the following features.

71. It is a system: It comprises a pump source and a laser including a laser medium; a controller; The aforementioned controller is: For irradiation with the aforementioned laser, multiple target areas of the patient's eye are designated in sequence. By driving the pump source and initiating pumping of the laser medium with a series of laser oscillation generation pulses, each configured to cause the laser medium to oscillate, the irradiation of the target region is initiated. Following the commencement of irradiation of the target region, the pump source is instructed to replace one of the laser oscillation generation pulses with one or more heating pulses. It is configured in such a way, The heating pulse is configured to heat the laser medium without causing the laser medium to oscillate. A system characterized by the following features.

72. The system according to claim 71, wherein the controller is further configured to heat the laser medium without causing the laser medium to oscillate before starting irradiation of the target area.

73. The system according to claim 71, characterized in that the total energy of the heating pulse is between 70 and 100% of the energy of each laser oscillation generation pulse.

74. The system according to any one of claims 71 to 73, characterized in that the one or more heating pulses consist of heating pulses where N > 1.

75. The system according to claim 74, wherein each of the heating pulses has a heating pulse duration of D0 / N, where D0 is the laser oscillation generation pulse duration of each of the laser oscillation generation pulses.

76. The system according to claim 75, characterized in that each of the heating pulses has a peak power equal to the peak power of each of the laser oscillation generation pulses.

77. The system according to claim 74, characterized in that the sequence of laser oscillation generation pulses is periodic with period T, and the controller is configured to replace the pump source with a heating pulse at a time {k*T / N}, k=0...N-1 from the time when one of the laser oscillation generation pulses is pumped.

78. The system according to any one of claims 71-73, characterized in that the controller is configured to replace the pump source with a heating pulse in response to a signal indicating an error.

79. The system according to any one of claims 71 to 73, wherein the controller is further configured to process one or more images of the eye acquired by the camera, and the controller is configured to replace the pump source with a heating pulse in response to the processing of the images.

80. The system according to claim 79, wherein the controller is configured to identify the eye impairment by processing the image, and the controller is configured to cause the pump source to be replaced with the heating pulse in response to the identification of the eye impairment.

81. The system according to claim 79, wherein the controller is configured to identify changes in the eye by processing the image, and the controller is configured to cause the pump source to be replaced with the heating pulse in response to the identification of changes in the eye.

82. The system according to claim 81, characterized in that the change in the eye includes the formation of one or more bubbles.

83. The controller is configured to determine the reference point position of the reference point on the eye by processing the image, The aforementioned controller further Based on the aforementioned reference point position, the position of one target region is calculated, and Confirm that the laser is not directed at the target region. It is configured in such a way, The system according to claim 79, characterized in that the controller is configured to cause the pump source to be replaced with the heating pulse in response to the confirmation.

84. The system according to 83, further comprising one or more motors, wherein the controller is further configured to use the motors to aim the laser, and the controller is configured to confirm in response to respective signals from each encoder of the motors that the laser is not directed at the target area position.

85. The aforementioned laser is a therapeutic laser, The aforementioned system further comprises a targeting laser, The aforementioned controller further: The treatment laser is made to emit a targeting beam at the position that the targeting laser is aiming at. The position of the aiming beam is identified by processing the aforementioned image. It is configured in such a way, The system according to 83, wherein the controller is configured to confirm that the therapeutic laser is not directed at the target area based on the deviation between the aiming beam position and the target area position.

86. The system according to claim 85, characterized in that the wavelength of the aiming beam is greater than 700 nm.

87. The aforementioned image comprises: a first image taken while the aiming beam is being emitted and in which the aiming beam appears in the first image; and a second image taken before or after the aiming beam is being emitted and in which the aiming beam does not appear in the second image; The controller is configured to identify the aiming beam position in the first image, The system according to 85, characterized in that the controller is configured to identify the reference point position in the second image.

88. The aforementioned image consists of a single image including a first frame in which the aiming beam appears and a second frame in which the aiming beam does not appear. The controller is configured to identify the aiming beam position within the first frame, The system according to 85, characterized in that the controller is configured to identify the reference point position within the second frame.

89. Method: The steps include: specifying multiple target areas of the patient's eye for continuous laser irradiation; initiating irradiation of the target areas by driving a pump source to start pumping the laser medium with a series of laser oscillation generating pulses, each configured to cause the laser medium of the laser to oscillate; and The step of initiating irradiation of the target region, followed by the step of instructing the pump source to replace one of the laser oscillation generation pulses with one or more heating pulses, wherein the heating pulses are configured to heat the laser medium without causing the laser medium to oscillate; A method characterized by having the following:

90. The method according to 89, further comprising the step of heating the laser medium with respect to the pump source without causing the laser medium to oscillate before starting irradiation of the target region.

91. The method according to 89, characterized in that the total energy of the heating pulse is between 70 and 100% of the energy of each laser oscillation generation pulse.

92. The method according to any one of claims 89-91, characterized in that the one or more heating pulses consist of heating pulses where N > 1.

93. The method according to 92, characterized in that each of the heating pulses has a heating pulse duration of D0 / N, where D0 is the duration of each laser oscillation generation pulse of the laser oscillation generation pulse.

94. The method according to 93, characterized in that each of the heating pulses has a peak power equal to the peak power of each of the laser oscillation generation pulses.

95. The method according to 92, characterized in that the sequence of laser oscillation generation pulses is periodic with period T, and the step of replacing the pump source with the heating pulse comprises replacing the pump source with the heating pulse at a time {k*T / N} k = 0...N-1 from the time when one of the laser oscillation generation pulses was excited.

96. The method according to any one of claims 89 or 91, characterized in that the step of replacing the pump source with a heating pulse includes the step of replacing the pump source with a heating pulse in response to a signal indicating an error.

97. The method according to any one of claims 89 or 91, further comprising the step of processing one or more images of the eye acquired by a camera, wherein the step of replacing the pump source with a heating pulse is the step of replacing the pump source with a heating pulse in response to the processing of the images.

98. The method according to 97, characterized in that the step of processing the image includes a step of identifying an obstruction to the eye, and the step of replacing the pump source with the heating pulse includes a step of replacing the pump source with the heating pulse in response to the identification of the obstruction to the eye.

99. The method according to 97, wherein the step of processing the image includes a step of identifying the change in the eye, and the step of replacing the pump source with the heating pulse includes a step of replacing the pump source with the heating pulse in response to the identification of the change.

100. The method according to 99, characterized in that the change in the eye includes the formation of one or more bubbles.

101. The step of processing the image includes the step of identifying the reference point position of the reference point of the eye, The aforementioned method further: The steps include: calculating the target region position of one of the target regions based on the reference point position; and The steps include: confirming that the laser is not directed at the target region; It has, The method according to 97, characterized in that the step of replacing the pump source with a heating pulse is performed in response to the confirmation.

102. The method according to 101, wherein the laser is aimed using one or more motors, and the step of confirming that the laser is not directed at the target area position includes confirming that the laser is not directed at the target area position in response to the respective signals from the respective encoders of the motors.

103. The aforementioned laser is a therapeutic laser, The method further includes the step of causing the targeting laser to emit a targeting beam to the location where the therapeutic laser is aimed, The step of processing the image further includes the step of identifying the aiming beam position of the aiming beam, The method according to 101, characterized in that the step of confirming that the therapeutic laser is not directed at the target region position includes the step of confirming that the therapeutic laser is not directed at the target region position based on the deviation between the aiming beam position and the target region position.

104. The method according to 103, characterized in that the wavelength of the aiming beam is greater than 700 nm.

105. The aforementioned image comprises a first image acquired while the aiming beam is being emitted and in which the aiming beam appears in the first image, and a second image acquired before or after the aiming beam is being emitted and in which the aiming beam does not appear in the second image. The step of identifying the aiming beam position includes the step of identifying the aiming beam position in the first image, The method according to 103, characterized in that the step of identifying the reference point position includes the step of identifying the reference point position in the second image.

106. The aforementioned image consists of a single image including a first frame in which the aiming beam appears and a second frame in which the aiming beam does not appear. The step of identifying the aiming beam position includes the step of identifying the aiming beam position within the first frame, The method according to 103, characterized in that the step of identifying the reference point position includes the step of identifying the reference point position within the second frame.