Systems and methods for prophylactic eye treatment using an excimer laser unit

Abstract

A method for treating a patient with an eye disease includes determining in a preoperative analysis of the patient that the patient is at risk for developing glaucoma. The method further includes treating the patient with an excimer laser to prophylactically treat glaucoma based on the determination in the preoperative analysis that the patient is at risk for developing glaucoma. Systems and methods also relate to treating patients with angle-closure or narrow-angle glaucoma using an excimer laser unit. Systems and methods also relate to combining an excimer laser with phacoemulsification to treat an eye. Systems and methods also relate to applying excimer laser energy in a transverse orientation to Schlemm's canal within the eye.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to and the benefit of U.S. Patent Application No. 17 / 899,285, filed August 30, 2022, U.S. Patent Application No. 17 / 899,310, filed August 30, 2022, U.S. Patent Application No. 17 / 899,330, filed August 30, 2022, and U.S. Patent Application No. 17 / 899,350, filed August 30, 2022, the entire contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] Glaucoma is a group of eye diseases that cause damage to the optic nerve and lead to vision loss. While glaucoma can affect people of all ages, it is more common in older people and is one of the leading causes of blindness in people over the age of 60. Glaucoma can be caused by higher than normal intraocular pressure within the eye, which can lead to atrophy of the optic nerve and subsequent visual field loss, and ultimately to blindness if left untreated. Summary of the Invention

[0003] An exemplary method of treating a patient having an eye disease includes determining in a pre-operative analysis of the patient that the patient is at risk for developing glaucoma, the method further including treating the patient with an excimer laser to prophylactically treat the glaucoma based on the determination in the pre-operative analysis that the patient is at risk for developing glaucoma.

[0004] In various embodiments, the patient is diagnosed in a pre-operative analysis as having cataracts and being at risk for developing glaucoma.

[0005] In various embodiments, application of excimer laser energy to prophylactically treat glaucoma occurs even if the patient has not been diagnosed with glaucoma.

[0006] In various embodiments, application of excimer laser energy to prophylactically treat glaucoma occurs before elevated intraocular pressure (IOP) is observed in the patient's eye.

[0007] In various embodiments, application of excimer laser energy to prophylactically treat glaucoma occurs even when the patient does not actually have glaucoma.

[0008] In various embodiments, the risk is a congenital risk.

[0009] In various embodiments, the inherited risk is associated with the patient's family history, race, sex, or a combination thereof.

[0010] In various embodiments, the risk is the presence of a comorbidity.

[0011] In various embodiments, the presence of a co-morbidity includes elevated intraocular pressure, obesity, diabetes, angle-closure glaucoma, tobacco use, alcohol use, or a combination thereof.

[0012] In various embodiments, the risk is an age-related risk.

[0013] In various embodiments, age-related risks include being 40 years of age or older, being 45 years of age or older, being 50 years of age or older, being 55 years of age or older, being 60 years of age or older, being 65 years of age or older, being 70 years of age or older, being 75 years of age or older, or being 80 years of age or older.

[0014] In various embodiments, the method includes determining that a patient has a cataract in a pre-operative analysis of the patient, and performing phacoemulsification ultrasound on the patient diagnosed with the cataract.

[0015] In various embodiments, phacoemulsification and treating the patient with an excimer laser to prophylactically treat glaucoma are performed on the patient during the same surgical procedure.

[0016] In various embodiments, phacoemulsification and treating the patient with an excimer laser to prophylactically treat glaucoma are performed through the same incision in the patient's eye.

[0017] In various embodiments, the method includes anesthetizing the patient prior to applying the phacoemulsification and excimer laser.

[0018] In various embodiments, treating a patient with an excimer laser includes applying shots of pulsed energy from an excimer laser.

[0019] An exemplary method of treating a patient having an eye disease includes determining in a pre-operative analysis of the patient that the patient is at risk for developing glaucoma. The method further includes applying phacoemulsification to the patient through an incision in the patient's eye, where the patient has been diagnosed with a cataract in the eye. The method further includes applying excimer laser energy through the incision in the eye to prophylactically treat the glaucoma based on the determination in the pre-operative analysis that the patient is at risk for developing glaucoma.

[0020] In various embodiments, the risk is an inherited risk associated with the patient's family history, race, sex, or a combination thereof.

[0021] In various embodiments, the risk is an age-related risk or the presence of a comorbidity.

[0022] An exemplary device for applying laser energy to the surface of the trabecular meshwork of an eye includes an excimer laser source and a probe configured to connect to the excimer laser source. The device further includes a delivery tip connected to the probe. The probe is configured for insertion into the eye of a subject who does not have glaucoma and who has been determined to be at risk for developing glaucoma in a preoperative analysis. The probe is further configured to apply a shot from the excimer laser source to form a perforation in the trabecular meshwork.

[0023] An exemplary method of treating a patient with an eye disease includes determining that the patient has angle-closure glaucoma or narrow-angle glaucoma, the method further including treating the angle-closure glaucoma or narrow-angle glaucoma in a surgical procedure performed on the patient, the method further including treating the patient with an excimer laser in the surgical procedure, and forming multiple perforations in the trabecular meshwork by irradiating the trabecular meshwork with multiple shots from the excimer laser.

[0024] In various embodiments, treating angle-closure or narrow-angle glaucoma includes administering phacoemulsification to the patient.

[0025] In various embodiments, phacoemulsification involves breaking up the lens of the eye.

[0026] In various embodiments, the method includes removing the lens from the patient's eye after breaking up the lens.

[0027] In various embodiments, the method includes replacing the lens of the eye with an artificial lens after removing the lens.

[0028] In various embodiments, the artificial lens is thinner than the lens that is removed from the eye.

[0029] In various embodiments, the intraocular lens provides a flow path for fluid drainage between the intraocular lens and the iris of the eye.

[0030] In various embodiments, angle-closure or narrow-angle glaucoma causes at least partial obstruction of fluid flow from the anterior chamber of the eye, located between the cornea of ​​the eye and the lens of the eye, through the trabecular meshwork, due to bulging of the iris of the eye.

[0031] In various embodiments, treating angle-closure or narrow-angle glaucoma reduces iris bulging.

[0032] In various embodiments, treating the patient with an excimer laser occurs after the bulging of the iris has been reduced.

[0033] In various embodiments, treating the patient with an excimer laser includes inserting an excimer laser probe into an incision in the patient's eye.

[0034] In various embodiments, treating angle-closure or narrow-angle glaucoma includes inserting a phacoemulsification probe into an incision in the patient's eye.

[0035] In various embodiments, the incision is about 1 / 8 inch or less in length.

[0036] In various embodiments, the plurality of shots is at least 10 shots.

[0037] In various embodiments, the method further includes anesthetizing the patient before treating the angle-closure or narrow-angle glaucoma and before treating the patient with the excimer laser.

[0038] In various embodiments, the excimer laser includes a xenon chloride laser source.

[0039] An exemplary method for treating a patient with an eye disease includes determining that the patient has angle-closure or narrow-angle glaucoma. The method further includes administering phacoemulsification to the patient to treat the angle-closure or narrow-angle glaucoma during a surgical procedure performed on the patient. The phacoemulsification is administered via a phacoemulsification probe inserted through an incision in the patient's eye. The method further includes treating the patient with an excimer laser during the surgical procedure, forming multiple perforations in the trabecular meshwork by applying multiple shots from the excimer laser to the trabecular meshwork. The multiple shots are applied via the excimer laser probe inserted through the incision.

[0040] In various embodiments, phacoemulsification involves breaking up the lens of the eye.

[0041] In various embodiments, the patient is treated with an excimer laser after phacoemulsification is applied.

[0042] An exemplary device for delivering laser energy to the surface of the trabecular meshwork of an eye includes an excimer laser source and a probe configured to connect to the excimer laser source. The device further includes a delivery tip connected to the probe. The probe is configured for insertion into the eye of a subject with angle-closure glaucoma or narrow-angle glaucoma. The probe is further configured for insertion into the eye after the subject has been treated for angle-closure glaucoma or narrow-angle glaucoma. The probe is configured to deliver a shot from the excimer laser source to form a perforation in the trabecular meshwork.

[0043] An exemplary device for treating an eye includes a housing, an excimer laser source within the housing, an ultrasound generator within the housing, an irrigation source within the housing, and a suction source within the housing.

[0044] In various embodiments, the housing is a unitary housing.

[0045] In various embodiments, the device further includes wheels attached to the housing to allow the device to be moved.

[0046] In various embodiments, the device further includes two foot pedals, or the housing has two receptacles, each configured to receive a connector for a foot pedal.

[0047] In various embodiments, the excimer laser source is controllable using a first of two foot pedals.

[0048] In various embodiments, at least one of the ultrasound generator, the irrigation source, and the suction source is controllable using the second of the two foot pedals.

[0049] In various embodiments, the device further includes a single power cord connected to the housing and connectable to a power outlet.

[0050] In various embodiments, the excimer laser source, the ultrasound generator, the irrigation source, and the suction source are each powered via a single power cord.

[0051] In various embodiments, the device further includes a port for connecting an excimer laser probe to the housing.

[0052] In various embodiments, the port is a first port and the device further includes a second port for connecting a phacoemulsification probe to the housing.

[0053] In various embodiments, the ultrasound generator, irrigation source, and aspiration source are configured for use with a phacoemulsification probe to perform phacoemulsification on a subject's eye.

[0054] In various embodiments, the excimer laser source is configured for use with an excimer laser probe to perform an excimer laser trabeculotomy (ELT) procedure on a subject's eye.

[0055] In various embodiments, the device further includes a display on the housing.

[0056] In various embodiments, the device further includes an energy monitoring port on the housing.

[0057] In various embodiments, the energy monitoring port is configured to receive a first distal end of a phacoemulsification probe and a second distal end of an excimer laser probe.

[0058] In various embodiments, the device further includes a sensor in the energy monitoring port configured to receive light emitted by the phacoemulsification probe and the excimer laser probe to calibrate the power emitted by the phacoemulsification probe and the power emitted by the excimer laser probe, respectively.

[0059] An exemplary device for treating an eye includes a housing and an excimer laser source within the housing configured to perform excimer laser trabeculotomy (ELT). The device further includes components configured to perform phacoemulsification, the components including an ultrasound generator within the housing, an irrigation source within the housing, and an aspiration source within the housing.

[0060] In various embodiments, the device further includes a single power cord connected to the housing and connectable to a power outlet.

[0061] In various embodiments, the device further includes a first port for connecting an excimer laser probe to the housing and a second port for connecting a phacoemulsification probe to the housing.

[0062] An exemplary method for treating an eye includes performing excimer laser trabeculotomy (ELT) using an excimer laser source contained in a single housing. The method further includes performing phacoemulsification using components contained in the single housing. The components include an ultrasound generator within the housing, an irrigation source within the housing, and an aspiration source within the housing.

[0063] An exemplary method of applying laser energy to a surface of the trabecular meshwork of an eye includes inserting a probe into the eye and applying shots of laser energy via the probe to multiple locations along the trabecular meshwork to form multiple perforations in the trabecular meshwork, the multiple perforations forming straight or curved lines that traverse Schlemm's canal within the eye.

[0064] In various embodiments, the laser energy is delivered from an excimer laser source.

[0065] In various embodiments, multiple perforations are formed in the trabecular meshwork to treat glaucoma.

[0066] In various embodiments, at least one of the plurality of perforations in the trabecular meshwork is misaligned with (offset from) Schlemm's canal.

[0067] In various embodiments, at least one of the plurality of perforations in the trabecular meshwork does not provide fluid communication between Schlemm's canal and the anterior chamber of the eye, which is located between the cornea of ​​the eye and the lens of the eye.

[0068] In various embodiments, at least one of the plurality of perforations in the trabecular meshwork is aligned with (at a location corresponding to) Schlemm's canal.

[0069] In various embodiments, at least one of the plurality of perforations in the trabecular meshwork forms fluid communication between Schlemm's canal and the anterior chamber of the eye, which is located between the cornea of ​​the eye and the lens of the eye.

[0070] In various embodiments, a light source, including a goniolens, endoscope, or other illumination source, assists in adjusting the placement of the probe.

[0071] In various embodiments, the multiple shots include 10 shots per eye.

[0072] In various embodiments, the multiple shots include more than 10 shots per eye.

[0073] In various embodiments, each of the plurality of perforations has a diameter of about 200 μm.

[0074] In various embodiments, the probe is inserted into an incision in the eye.

[0075] In various embodiments, the method further includes analyzing the effectiveness of the shot by visualizing the drainage of aqueous humor and backflow of blood.

[0076] In various embodiments, the probe is a fiber optic probe.

[0077] In various embodiments, the laser energy is delivered from an excimer laser source, including a xenon chloride laser.

[0078] In various embodiments, the method further includes physically contacting the probe with the trabecular meshwork while delivering the multiple shots, whereby multiple perforations are formed while the probe is in physical contact with the trabecular meshwork.

[0079] An exemplary method for applying laser energy to a surface of the trabecular meshwork of an eye includes inserting a probe into an eye of a subject with glaucoma and adjusting the placement of the probe to a first position near the trabecular meshwork of the eye. The method further includes applying a first shot from a laser source to form a first perforation in the trabecular meshwork. The method further includes adjusting the placement of the probe to a second position near the trabecular meshwork. The method further includes applying a second shot from the laser source to form a second perforation in the trabecular meshwork. The first perforation and the second perforation form a line that intersects Schlemm's canal of the eye.

[0080] In various embodiments, the method further includes adjusting the position of the probe to a subsequent position near the trabecular meshwork and applying subsequent shots from the laser source to form subsequent perforations in the trabecular meshwork, the first perforation, the second perforation, and the subsequent perforations forming a straight or curved line across Schlemm's canal of the eye.

[0081] In various embodiments, the laser source includes an excimer laser source.

[0082] An exemplary device for treating glaucoma by applying laser energy to the surface of the trabecular meshwork of an eye includes an excimer laser source and a probe configured to connect to the excimer laser source. The device further includes a delivery tip connected to the probe. The probe is configured to be inserted into the eye of a subject with glaucoma, move to a first position proximate the trabecular meshwork of the eye, apply a first shot from the excimer laser source to form a first perforation in the trabecular meshwork, move to a second position proximate the trabecular meshwork, and apply a second shot from the excimer laser source to form a second perforation in the trabecular meshwork. The first perforation and the second perforation form a line that crosses Schlemm's canal of the eye. [Brief explanation of the drawings]

[0083] [Figure 1] FIG. 1 is a schematic cross-sectional view illustrating the internal tissue structure of an eye (eyeball). [Figure 2]FIG. 1 is a partial perspective view of the anatomy within the anterior chamber of the eye showing the corneoscleral angle. [Figure 3] FIG. 1 illustrates an excimer laser system of the present disclosure. [Figure 4] FIG. 1 illustrates an embodiment of an excimer laser system. [Figure 5] FIG. 1 illustrates an embodiment of a probe for use with an excimer laser system. [Figure 6] FIG. 1 illustrates an embodiment of a probe for use with an excimer laser system. [Figure 7] 1 is a schematic cross-sectional view of an eye according to one embodiment. [Figure 8] FIG. 1 is a schematic cross-sectional view of an eye with an auxiliary light source. [Figure 9] FIG. 1 is an enlarged schematic cross-sectional view of one embodiment. [Figure 10] 1 is a flowchart of one embodiment of a method for administering ELT after preoperative analysis. [Figure 11] 1 is a flow chart of one embodiment of performing pre-operative analysis and ELT treatment of a patient. [Figure 12A] FIG. 1 shows a normal eye. [Figure 12B] FIG. 1 illustrates an eye with angle-closure glaucoma. [Figure 13] FIG. 1 illustrates one embodiment of a system for Phaco and ELT therapy. [Figure 14] FIG. 1 illustrates one embodiment of a system for combined Phaco and ELT therapy. [Figure 15] FIG. 1 illustrates one embodiment of the Phaco system. [Figure 16] FIG. 1 shows an embodiment of a Phaco probe. [Figure 17] FIG. 1 illustrates one embodiment of a foot pedal. [Figure 18] FIG. 1 illustrates one embodiment of a foot pedal. [Figure 19] FIG. 1 illustrates one embodiment of a foot pedal. [Figure 20]FIG. 1 illustrates one embodiment of a foot pedal. [Figure 21A] FIG. 1 illustrates one embodiment of a combined ELT and Phaco system. [Figure 21B] FIG. 1 illustrates one embodiment of a combined ELT and Phaco system. [Figure 22] FIG. 7 is a cross-sectional view of the probe taken along line AA in FIG. 6. [Figure 23] FIG. 7 is a cross-sectional view of the probe taken along line BB in FIG. 6. [Figure 24] FIG. 10 is a close-up view of the probe's delivery tip, which emits both visible light to illuminate the field of view and laser energy for photoablation of the target tissue. [Figure 25] 7 is an alternative cross-sectional view of the probe taken along line AA in FIG. 6. [Figure 26] 7 is an alternative cross-sectional view of the probe taken along line BB in FIG. 6. [Figure 27] FIG. 1 illustrates an excimer laser system of the present disclosure. [Figure 28] 1 illustrates the authentication of an excimer laser system and a laser probe used with the excimer laser system of the present disclosure. [Figure 29] FIG. 1 illustrates an embodiment of a probe for use with an excimer laser system. [Figure 30] FIG. 5 is a cross-sectional view of the probe taken along line AA in FIG. 4. [Figure 31] FIG. 5 is a cross-sectional view of the probe taken along line BB in FIG. 4. [Figure 32] FIG. 1 illustrates an embodiment of a laser probe attached to an excimer laser unit. [Figure 33] FIG. 10 is a close-up view of the connection between the laser probe and the excimer unit and the initial RFID reading that determines the authenticity of the laser probe. [Figure 34] 10 is a flow chart of one embodiment of authenticating a probe for use with an excimer laser unit. [Figure 35] 1 is a flow chart of one embodiment of preventing the use of unauthorized probes. [Figure 36] FIG. 1 illustrates an excimer laser system of the present disclosure. [Figure 37] FIG. 1 illustrates an excimer laser system of the present disclosure and how the system is used to calibrate the laser output to compensate for increased dispersion of the laser probe's optical fiber. [Figure 38] FIG. 10 illustrates a process for calibrating the laser output, which includes adjusting the laser energy output from the laser source to the laser probe to account for variations in the optical fiber core of the laser probe. [Figure 39] FIG. 1 illustrates an embodiment of a probe for use with an excimer laser system. [Figure 40] 1 is a flowchart of one embodiment of a method for applying ELT after a previous ineffective treatment. [Figure 41] FIG. 1 illustrates an embodiment of an ELT system with an interactive user interface. [Figure 42] 10 is a flow chart of one embodiment of a method using probe placement to form a perforation that forms a straight line across Schlemm's canal. [Figure 43] FIG. 1 is a partial perspective view of the anatomy within the anterior chamber of the eye showing the corneoscleral angle with a shot striking the trabecular meshwork in a transverse line. [Figure 44] FIG. 1 illustrates an excimer laser system of the present disclosure. [Figure 45] FIG. 1 illustrates an embodiment of an excimer laser unit. [Figure 46] FIG. 7 is a cross-sectional view of the probe taken along line AA in FIG. 6. [Figure 47] FIG. 7 is a cross-sectional view of the probe taken along line BB in FIG. 6. [Figure 48] FIG. 1 is an enlarged view of the distal portion of the probe. [Figure 49A] 10A-10C are enlarged views of the delivery tip of the probe with different tilt angles. [Figure 49B] 10A-10C are enlarged views of the delivery tip of the probe with different tilt angles. [Figure 50]10A-10C are enlarged views of the distal portion of the probe bent in different directions. [Figure 51] 10A-10C are enlarged views of the distal portion of the probe bent in different directions. [Figure 52] 1 is a flowchart of one embodiment of a method for applying ELT with programmable custom settings. [Figure 53] FIG. 1 illustrates a typical embodiment of an interactive user interface. DETAILED DESCRIPTION OF THE INVENTION

[0084] The main risk factor for glaucoma is increased intraocular pressure, which is higher than normal pressure inside the eye. Elevated intraocular pressure can lead to atrophy of the optic nerve and subsequent visual field loss, which, if left untreated, can ultimately lead to blindness.

[0085] Intraocular pressure correlates with the production of aqueous humor by the ciliary processes of the eye (eyeball) and its drainage through a tissue called the trabecular meshwork. The trabecular meshwork is a region of tissue in the eye located around the base of the cornea that drains aqueous humor into an intraocular lymphatic-like vessel called Schlemm's canal. The drained aqueous humor is then delivered to the bloodstream by Schlemm's canal. Proper flow and drainage of aqueous humor through the trabecular meshwork maintains a balanced, normal intraocular pressure. In open-angle glaucoma, the most common type of glaucoma, degeneration or blockage of the trabecular meshwork can slow or completely prevent aqueous humor drainage, leading to an accumulation of aqueous humor and elevated intraocular pressure. This pressure strain can damage and ultimately necrotize optic nerve fibers, resulting in permanent vision loss.

[0086] Early treatment can slow or stop the progression of glaucoma. Depending on the type of glaucoma, treatment options may include eye drops, oral medications, surgery, laser treatment, or any combination of these. For example, treatment for open-angle glaucoma may include surgical treatments such as filtration surgery, which creates an opening in the sclera of the eye and removes a portion of the trabecular meshwork, or surgical implantation of a stent or implant (i.e., drainage tube), which places a small tube shunt within the eye to facilitate drainage of fluid. However, such treatments are highly invasive and can cause many complications, such as leakage, infection, and hypotony (e.g., decreased intraocular pressure), and require long-term postoperative monitoring to prevent late complications.

[0087] Recently, minimally invasive laser treatments have been used to treat glaucoma. In such treatments, surgeons use lasers to thermally modify and / or create holes in various tissues, such as the trabecular meshwork and / or Schlemm's canal. For example, laser trabeculotomy is a procedure in which a surgeon directs the working end of a laser fiber through a corneal incision in the eye, near the trabecular meshwork, and applies laser energy to destroy portions of the trabecular meshwork, creating channels in the trabecular meshwork that allow aqueous humor to flow more freely into Schlemm's canal.

[0088] To fully understand the various embodiments described herein, an overview of the anatomy of the eye is provided. FIG. 1 is a schematic cross-sectional view illustrating the internal tissue structure of the eye (eyeball). As shown, the outer layer of the eye includes the sclera 17, which serves as the supporting framework of the eyeball. The anterior portion of the sclera includes the cornea 15, a transparent tissue that allows light to enter the eye. The anterior chamber 7 is located between the cornea 15 and the lens 4. The anterior chamber 7 contains a constantly flowing, clear fluid called aqueous humor 1. The lens 4 is connected to the eyeball by fibrous zonules, which are connected to the ciliary body 3. Within the anterior chamber 7, the iris 19 surrounds the lens 4 and contains the pupil 5 at its center. The pupil 5 regulates the amount of light passing through the lens 4. The posterior chamber 2 is located between the lens 4 and the retina 8.

[0089] FIG. 2 is a partial perspective view of the anatomy within the anterior chamber of the eye, illustrating the corneoscleral angle. As shown, the ocular anatomy further includes the trabecular meshwork 9, a thin band of spongy tissue surrounding the iris 19 within the eye. The trabecular meshwork has a variable shape and is minute in size. Its cross section is triangular, and its thickness ranges from 100 to 200 microns. The trabecular meshwork is composed of various fibrous layers with micron-sized pores that form fluid channels for draining aqueous humor. At its anterior end, the Schwalbe line 18, which is approximately where the cornea 15 and sclera 17 join, the trabecular meshwork 9 measures approximately 100 microns in thickness.

[0090] The trabecular meshwork spans approximately 200 microns at its base where the trabecular meshwork and iris 19 attach to the scleral spines. The channels leading to the ostia of the trabecular meshwork 9 open into a very thin, porous tissue called the juxtacanalicular trabecular meshwork 13, which in turn lines the Schlemm's canal 11. The Schlemm's canal 11 is filled with a mixture of aqueous humor and blood components and branches into collector channels 12 that drain the aqueous humor into the venous system. Because aqueous humor is constantly produced by the eye, blockages in either the trabecular meshwork, the juxtacanalicular trabecular meshwork, or the Schlemm's canal prevent aqueous humor from easily leaving the anterior chamber, resulting in elevated intraocular pressure.

[0091] The eye has an outflow system for draining aqueous humor 1, located at the corneoscleral angle. Generally, the ciliary body 3 produces aqueous humor 1. Aqueous humor flows from the posterior chamber 2 through the pupil 5 into the anterior chamber 7, then into the trabecular meshwork 9, and into Schlemm's canal 11, where it drains into collector channels 12 and aqueous veins. Blockage of aqueous humor outflow occurs in most cases of open-angle glaucoma (i.e., glaucoma characterized by readily visible trabecular meshwork during gonioscopy) and is typically localized to the region of the juxtacanalicular trabecular meshwork 13, located between the trabecular meshwork 9 and Schlemm's canal 11, or more specifically, the inner wall of Schlemm's canal. It is desirable to overcome this blockage by improving the eye's ability to utilize its innate drainage system.

[0092] For example, if a blockage occurs in the para-Schlemm's canal trabecular meshwork 13, it can cause a gradual increase in intraocular pressure over time, which can lead to optic nerve damage and atrophy, subsequent visual field loss, and ultimately blindness if left untreated. The laser probe of the present embodiment is well suited for use in treating glaucoma. Specifically, as described in more detail herein, the laser probe is configured to be connected to a laser source and transmit (irradiate) laser energy from the laser source to the trabecular meshwork 13, resulting in photoablation of tissue (including at least the trabecular meshwork 13 and, optionally, Schlemm's canal 11) and the formation of channels in the trabecular meshwork (and, optionally, Schlemm's canal 11), thereby improving fluid drainage into Schlemm's canal 11 and reducing intraocular pressure in the eye.

[0093] 3 illustrates an excimer laser system 100 of the present disclosure. The system 100 includes a probe member 102, which includes a laser transmitting member 103 and an illumination member 104, a controller 106, a laser source 108, and a light source 110. As described in more detail herein, many of the components of the laser system 100 are housed in a housing, such as a movable platform, that is provided in the environment where the procedure will be performed (e.g., an operating room, treatment room, outpatient clinic, etc.), and the probe member 102 can be connected to the housing for use during the procedure. When the probe member 102 is connected to the housing, the laser transmitting member 103 and the illumination member 104 are connected to the laser source 108 and the light source 110, respectively. The controller 106 allows an operator (i.e., a surgeon or other medical professional) to control the output of the laser signal (from the laser source 108 to the laser transmitting member 103), and thus the transmission (irradiation) of laser energy from the laser transmitting member 103 of the probe member 102. Additionally, the controller 106 allows an operator to control the output of the light signal (from the light source 110 to the lighting element 104 ), and thus the emission of light from the lighting element 104 .

[0094] The controller 106 may include software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions, instruction sets, and / or data in a memory device. As used in any embodiment herein, "circuitry" may include, alone or in any combination, hardwired circuitry, programmable circuitry such as a computer processor including one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by the programmable circuitry. For example, the controller 106 may include a hardware processor coupled to non-transitory computer-readable memory, the non-transitory computer-readable memory including instructions executable by the processor to cause the controller to perform various functions of the laser system 100 described herein, including controlling the laser and / or illumination output.

[0095] The laser source 108 can include an excimer laser 112 and a gas cartridge 114 that provides the laser 112 with an appropriate gas combination. The excimer laser 112 is a form of ultraviolet (UV) laser, which typically operates in the UV spectral region and generates nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cartridge 114) is typically a gas mixture containing a noble gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate electrical stimulation and high pressure, pseudo-molecules called excimers (or exciplexes in the case of noble gas halides) are created, which can exist only in an excited state and generate laser light in the UV range.

[0096] Laser action in excimer molecules occurs because the excimer molecules have a bonded (associative) excited state but a repulsive (dissociative) ground state. Rare gases, such as xenon and krypton, are highly inert and do not normally form compounds. However, when excited (induced by an electric discharge or a high-energy electron beam), rare gases can form temporarily bonded molecules with themselves (excimers) or with halogens, such as fluorine or chlorine (exciplexes). The excited compounds release excess energy through spontaneous or stimulated emission, resulting in highly repulsive ground-state molecules that very rapidly (on the order of picoseconds) dissociate back into two unbonded atoms. This creates a population inversion. The excimer laser 112 in the present system 100 is a XeCl (xenon-chlorine) excimer laser emitting at a wavelength of 308 nm.

[0097] The light source 110 provides a light signal within the visible light spectrum to the illumination member 104. Accordingly, the illumination source 110 may include, but is not limited to, an incandescent light source, a fluorescent light source, a halogen light source, a high intensity discharge light source, a metal halide light source, and a light emitting diode (LED) light source.

[0098] FIG. 4 illustrates one embodiment of the excimer laser system 100 provided in an instrument 400. As previously described, one or more components of the system 100 may be housed within the instrument 400. In this embodiment, the controller 106, the laser source 108 (including the excimer laser 112 and gas cartridge 114), and the light source 110 are housed within a housing 402. The housing 402 has wheels 404 for portability. The instrument 400 also includes a push / pull handle 405 to aid in the portability of the instrument 400. The instrument 400 also includes a connection port 406 for receiving the connecting end of the probe member 102, thereby establishing a connection between the laser transmitting member 103 and the illumination member 104 and the corresponding laser source 108 and light source 110, respectively. The instrument 400 also includes various inputs for an operator, such as a fiber probe cap holder 408, an emergency stop button 410, and a power switch 412. The instrument 400 further includes a foot pedal 414 extending from the housing 402 and operable to control the delivery of shots from the excimer laser 412 to the laser transmitting member 103 of the probe 102. The instrument 400 further includes a display 416, which may take the form of an interactive user interface. In some examples, the interactive user interface 410 displays patient information, machine settings, and treatment information.

[0099] FIG. 5 illustrates one embodiment of a probe 500 for use with the excimer laser system 100, showing the probe 500 with a cap attached to the distal delivery tip 506. FIG. 6 illustrates one embodiment of the probe 500 with the cap 514 removed to expose the delivery tip 506 of the probe 500. The probe 500 is a single-use disposable unit. The probe 500 generally includes a laser transmitting member and an illumination member, as previously described herein, and is connected to their respective sources (i.e., the laser source 108 and the light source 110). This connection is made via a connector 502 (elongated cord) extending from the body of the probe 500 and having a connection assembly 504 configured to be received in the connection port 406 of the instrument 400. The probe 500 further includes a delivery tip 506 from which laser energy (from the laser transmitting member) and visible light (from the illumination member) can be emitted. The probe 500 includes a handheld body 508, which may include a finger grip 510 having protrusions or indentations 512. The body 508 of the handheld probe 500 may be made of metal or plastic.

[0100] FIG. 7 is a schematic cross-sectional view of an eye 2100 showing the internal anatomical structures. FIG. 8 is a schematic cross-sectional view of the eye 2100 with a light source 2190, such as a goniolens, endoscope, or other light source. FIG. 9 is a magnified schematic cross-sectional view of the eye. The outer layer, or sclera 2130, serves as the eye's supporting structure. The anterior portion of the outer layer 2130 includes the cornea 2125, a transparent tissue that allows light to enter the eye. Between the cornea 2125 and the lens 2110 is the anterior chamber 2135, and behind the lens 2110 is the posterior chamber. The anterior chamber 2135 contains a constantly flowing, clear body fluid called aqueous humor. Within the anterior chamber 2135, the iris 2120 surrounds the lens 2110 and includes the pupil, which regulates the amount of light passing through the lens 2110.

[0101] The eye further includes the trabecular meshwork 2140, a thin band of spongy tissue that surrounds the iris 2120 within the eye. The trabecular meshwork is variable in shape and minute in size. Its cross section is triangular, and its thickness varies from 100 to 200 microns. It is composed of various fibrous layers with micron-sized pores that form channels through which aqueous humor drains. The trabecular meshwork 2140 measures approximately 100 microns in thickness at its anterior end, known as Schwalbe's line, which is approximately where the cornea and sclera join.

[0102] The trabecular meshwork spans approximately 200 microns at its base where the trabecular meshwork and iris 2120 attach to the scleral spines. The flow path through the ostia of the trabecular meshwork 2140 passes through a very thin, porous tissue called the juxta-canalicular trabecular meshwork, which in turn lines the surface of a tissue called Schlemm's canal 2150. Schlemm's canal 2150 is filled with a mixture of aqueous humor and blood components and branches into collector channels that drain the aqueous humor into the venous system. Because aqueous humor is constantly produced by the eye, blockages in either the trabecular meshwork, the juxta-canalicular trabecular meshwork, or Schlemm's canal prevent aqueous humor from easily draining from the anterior chamber, resulting in increased intraocular pressure within the eye.

[0103] The eye has a drainage system that drains aqueous humor. Aqueous humor flows from the posterior chamber behind the lens 2110 through the pupil into the anterior chamber 2135, then into the trabecular meshwork 2140, into Schlemm's canal 2150, and into the collector channels and aqueous veins. Blockage of aqueous humor outflow occurs in most cases of open-angle glaucoma (i.e., glaucoma characterized by a trabecular meshwork that is readily visible during gonioscopy) and is typically localized to the region of the juxta-canalicular trabecular meshwork, located between the trabecular meshwork 2140 and Schlemm's canal 2150, and more specifically, the inner wall of Schlemm's canal. Blockages such as those in the juxta-canalicular trabecular meshwork or Schlemm's canal cause a gradual increase in intraocular pressure over time, which can lead to optic nerve damage and atrophy, subsequent visual field defects, and ultimately blindness if left untreated.

[0104] Laser probes according to various embodiments are used to treat glaucoma. The delivery tip of a laser probe 2160 is guided through a small incision (typically about ⅛ inch or smaller) in the cornea 2125 of the eye, across the anterior chamber 2135, and into the vicinity of Schlemm's canal 2150. The probe is guided approximately horizontally through the anterior chamber to avoid perforating the cornea within the field of view. The laser probe is connected to a laser source, which transmits (irradiates) laser energy from the laser source into the trabecular meshwork 2140 and Schlemm's canal 2150, photoablating tissue including at least the trabecular meshwork 2140 and possibly Schlemm's canal 2150. Photoablation by the laser energy creates perforations in the trabecular meshwork and Schlemm's canal, thereby improving fluid drainage into Schlemm's canal 2150 and reducing intraocular pressure within the eye.

[0105] 9 illustrates the placement of a delivery tip 2160 at a location 2170 near Schlemm's canal 2150. Placing the laser near Schlemm's canal allows the laser light path to traverse the trabecular meshwork and reach Schlemm's canal. Placing the laser near Schlemm's canal allows for photoablation of a larger surface area of ​​the trabecular meshwork compared to placing the laser perpendicular or parallel to Schlemm's canal. Furthermore, if the laser's delivery tip were placed parallel to Schlemm's canal, the laser would not be able to photoablate any surface area of ​​the trabecular meshwork or Schlemm's canal.

[0106] [Risk factor-based ELT treatment and combined treatment with PHACO and ELT] Many people suffer from vision loss due to cataracts or glaucoma. Cataracts are common conditions caused by clouding or opacity in the lens of the eye, blocking light from entering the eye. The loss of vision experienced by patients with glaucoma is caused by damage to the optic nerve due to fluid buildup in the anterior chamber of the eye.

[0107] The risk of developing cataracts, glaucoma, or both increases with age, and many people over the age of 60 suffer from both vision-deteriorating diseases. Additionally, patients diagnosed with cataracts at a young age are at higher risk of developing glaucoma later in life. Patients diagnosed with either disease receive treatments ranging from medications to surgery.

[0108] Various embodiments provide systems and methods for providing preventative glaucoma treatment to patients undergoing cataract treatment. According to various embodiments, patients presenting for cataract removal are evaluated, and if appropriate, preventative treatment is administered to prevent glaucoma. Various embodiments leverage the insight that patients who develop cataracts, particularly at a young age, are more likely to develop glaucoma later in life, may be in the early stages of glaucoma development, or may be at higher risk for developing glaucoma due to family history, ethnic background, underlying medical conditions, or other factors. Various embodiments include evaluating patients with cataracts to determine whether additional treatment, such as those described below, would be beneficial in preventing the onset of glaucoma. Accordingly, methods of various embodiments include selecting patients undergoing cataract treatment for preventative glaucoma treatment. According to various embodiments herein, an excimer laser trabeculotomy (ELT) procedure is preferred for preventative glaucoma treatment, but it should be noted that other procedures known in the art may also be used for preventative glaucoma treatment.

[0109] In various embodiments described herein, the ELT procedure may be performed prophylactically, with or without the administration of other types of treatments described herein (such as phacoemulsification, as described below). Thus, the ELT procedure may be performed based on a patient's diagnosis of being at high risk for developing glaucoma or having a genetic or other risk factor for developing glaucoma as described herein.

[0110] Phacoemulsification (also referred to herein as "phaco") is a common method for removing cataracts. Various embodiments include administering phaco and ELT during the same surgical visit, thereby minimizing the number of surgeries for patients with multiple eye conditions. Phaco and ELT are less invasive than traditional surgeries, thereby minimizing patient recovery time. In fact, both phaco and ELT are performed through a single small incision made in the patient's eye. In various embodiments, a laser phaco procedure may be used in place of phacoemulsification. In such embodiments, a laser phaco device and / or a combination ELT / laser phaco device, as well as phacoemulsification and / or a combination ELT / phacoemulsification device, may be used in accordance with various embodiments herein. However, in various embodiments, regardless of what type of device is used (a standalone ELT device or a combination ELT / phaco device), the ELT procedure may be performed alone (without cataract treatment, such as phaco), for example, to treat glaucoma and / or to prophylactically treat glaucoma, as described herein.

[0111] In various embodiments, any cataract treatment can be used. Phacoemulsification is a preferred cataract treatment, in which a small incision is made in the peripheral cornea and an ultrasound probe is inserted. The incision is long enough to accommodate the ultrasound probe and additional instruments used in cataract removal. Typically, the incision is approximately 1 / 8 inch long. The ultrasound probe breaks the cataract into small pieces and removes them from the eye. The ultrasound probe typically has a titanium or steel needle that vibrates at ultrasonic frequencies to emulsify the cataract, and a pump aspirates the particles from the tip of the needle. To facilitate removal, the physician can use a chipping tool and irrigation device. A replacement, clear intraocular lens (IOL) is then inserted through the incision.

[0112] Prior to closing the incision, various embodiments of the method allow for the performance of excimer laser trabeculotomy for the preventative treatment of glaucoma. In various embodiments, an excimer laser is used to create perforations in the eye's Schlemm's canal and / or trabecular meshwork, thereby allowing fluid to drain from the eye. ELT treats open-angle glaucoma at its source by increasing the permeability of the trabecular meshwork. In ELT, the laser creates a direct connection between the anterior chamber and Schlemm's canal using a fiber probe that physically contacts the trabecular meshwork. The fiber probe consists of an optical fiber suitable for UV light, which is embedded in a handheld laser applicator. In some examples, a FIDO Laser Applicator manufactured by MLase AG is used as the fiber probe.

[0113] The ELT procedure involves directing laser light through a small corneal incision into the trabecular meshwork at the iridocorneal angle. A goniolens can be used to achieve effective and precise placement of the tip of the fiber probe in the trabecular meshwork to create a flow path to Schlemm's canal. Physicians use the goniolens to monitor intraoperatively for criteria such as reflux and mild reflux.

[0114] To facilitate easier drainage of aqueous humor to lower IOP, a total of approximately 10 ELT treatment sites, i.e., perforations (each approximately 200 μm in diameter), are laser-created in the trabecular meshwork and / or Schlemm's canal by laser ablation or photoablation. In comparison, the individual diameters of stents and implants are smaller, ranging from approximately 80 μm to approximately 120 μm. The excimer laser used for photoablation operates at a wavelength of 308 nm. In some instances, the excimer laser is a sealed xenon chloride (XeCl) excimer laser, such as the EXTRA LASER manufactured by MLase AG. Because ELT is a non-thermal procedure, no postoperative tissue reaction or activation occurs in the trabecular meshwork. Because ELT does not generate heat, postoperative activation of the tissue reaction is largely suppressed, resulting in stable, long-term intraocular pressure reduction. Furthermore, unlike traditional glaucoma treatments involving shunt or stent placement, ELT treatment maintains the stability of Schlemm's canal.

[0115] In various embodiments, the method includes treating a subject with one or more eye conditions and performing ELT as a preventative treatment. Phacoemulsification is performed on the subject with one or more eye conditions, and an excimer laser is applied to the subject's eye to increase blood flow to the subject's eye. Applying the excimer laser to the eye includes applying shots of pulsed energy from the excimer laser. In some examples, approximately 10 shots of pulsed energy are applied to the eye. In one example, the one or more eye conditions include cataracts and glaucoma.

[0116] In some cases, the excimer laser irradiation prophylactically treats glaucoma. The method of various embodiments further includes anesthetizing the subject prior to the phacoemulsification and application of the excimer laser. In some embodiments, the method of various embodiments further includes post-operative analysis. For example, the post-operative analysis includes observing fluid flowing from Schlemm's canal within the eye.

[0117] The system of various embodiments is used to treat a subject with one or more eye diseases. The system of various embodiments is used to treat cataracts and prophylactically treat glaucoma during the same surgical visit, thereby eliminating the need for multiple surgical procedures to treat the two diseases. Prophylactically treating glaucoma can prevent irreversible vision loss due to glaucoma. The system includes a phacoemulsification system including an ultrasound probe for treating cataracts in the subject's eye, and an excimer laser system including an excimer laser and a fiber probe for increasing blood flow to the subject's eye. In some examples, increasing blood flow to the eye prophylactically treats glaucoma in the subject.

[0118] Furthermore, the methods of various embodiments provide treatment for both conditions, thereby reducing or eliminating the need for medications to manage eye conditions. In one example, phaco is effective in restoring vision loss caused by cataracts, eliminating the need for medications to treat cataracts. In some examples, ELT treatment reduces IOP, reducing or eliminating the need for medications to treat glaucoma by reducing the amount of fluid produced or increasing fluid outflow, eliminating the need for IOP-lowering eye drops.

[0119] In one embodiment, a physician uses the system of various embodiments to perform phaco for the treatment of cataracts and ELT for the preventative treatment of glaucoma. An interactive user interface displays patient information, machine settings, and procedure information. The physician uses different instruments and probes depending on the treatment procedure. For example, the physician uses an ultrasound handheld probe for phaco and a fiber optic probe for ELT. The fiber probe includes an optical fiber having a tip. In some embodiments, the tip is composed of an optical fiber coated with stainless steel. In some cases, the tip is beveled. In certain embodiments, the fiber probe is disposable.

[0120] By using the foot pedal as a power source for each procedure, the physician can keep both hands free to use the probe and other instruments during the procedure. In some embodiments, the phacoemulsification system further includes a foot pedal to activate ultrasound delivery, irrigation, and aspiration to remove cataracts from the subject's eye. In some embodiments, the excimer laser system further includes a foot pedal to activate the excimer laser to deliver shots from the excimer laser to the subject's eye. For example, the foot pedal is used by the physician to power the fiber used in the ELT, such as by delivering laser shots.

[0121] Other instruments used by the physician include gonio lenses, tipping tools, and irrigators. The user interface provides any appropriate information. For example, the user interface provides device settings such as the number of laser shots to deliver per tap of the foot pedal. The user interface also displays patient and procedure information.

[0122] In some embodiments, the patient is administered an anesthetic prior to surgery. In some instances, the anesthesia is local. In some instances, the anesthesia includes anesthetic eye drops. In some instances, the patient is administered general anesthesia. In one example, the eye is first anesthetized using eye drops, and then an anesthetic is injected around the eye to prevent pain and excessive eye movement during surgery.

[0123] A method for treating a subject having one or more eye conditions includes administering phacoemulsification to the subject having one or more eye conditions and administering an excimer laser to the subject to prophylactically treat glaucoma. A system for treating one or more eye conditions in a subject includes a phacoemulsification system and an excimer laser system. Various embodiment methods and systems prophylactically treat glaucoma in a subject. The phaco system includes an ultrasound probe for treating cataracts in the subject. The excimer laser system includes an excimer laser and a fiber probe that delivers pulsed energy shots from the excimer laser to the eye.

[0124] Various embodiments provide methods and systems for treating both cataracts and glaucoma in a single surgical procedure. The method of various embodiments treats subjects with cataracts and glaucoma using phacoemulsification (phaco) and excimer laser trabeculotomy (ELT). Phaco removes the cataract and inserts a clear lens replacement. ELT increases the flow of aqueous humor within the eye by laser-perforating the trabecular meshwork. Phaco and ELT are performed during the same surgical visit, thereby minimizing the number of surgical procedures for patients with multiple eye conditions. Phaco and ELT are less invasive than traditional surgery, minimizing patient recovery time. In fact, both phaco and ELT are performed through a single small incision made in the eye.

[0125] In some cases, various embodiments provide a method for treating a diagnosed eye disease and prophylactically treating another eye disease during the same procedure. For example, a patient may be diagnosed with cataracts and require phaco surgery. Because some cataract patients have a congenital risk of developing glaucoma, various embodiments of the method administer prophylactic ELT treatment during the same surgical procedure as the phaco treatment. ELT treats glaucoma by increasing and / or improving aqueous humor outflow from the eye. Thus, a patient diagnosed with cataracts may be treated for both eye diseases, i.e., cataract and glaucoma, during the same surgical procedure.

[0126] FIG. 10 shows a flowchart of one embodiment 3100. Various embodiment methods relate to treating multiple eye conditions in a patient. In some instances, these methods include pre-operative analysis and diagnosis 3110 of the eye condition. In some embodiments, the diagnosed eye condition is cataract, requiring phacoemulsification. The patient may also have glaucoma. In various embodiments, excimer laser trabeculotomy (ELT) is used to treat glaucoma. In some cases, ELT is performed as a preventative treatment for glaucoma, as individuals with cataracts are at increased risk of developing glaucoma.

[0127] A patient with one or more eye conditions is prepared for surgery. The method includes administering anesthesia to the patient 3120. Local anesthesia is most commonly used, typically by instilling a local anesthetic, such as tetracaine or lidocaine, into the eye. Alternatively, lidocaine and / or long-acting bupivacaine anesthetics may be injected into the area surrounding the eye cone (peribulbar block) or behind the eye cone (retrobulbar block), thereby more fully immobilizing the extraocular muscles and minimizing pain. In some cases, a facial nerve block using lidocaine and bupivacaine may be administered to prevent eyelid closure. General anesthesia is recommended for children, those with traumatic eye injuries associated with cataracts, and anxious or uncooperative patients or animals. Cardiovascular monitoring is recommended with local anesthesia and required in general anesthesia settings. Appropriate sterile precautions, including the use of antiseptics such as povidone-iodine, are used to prepare the surgical site. Sterile drapes, gowns, and gloves are donned. A plastic sheet with a container helps contain the fluid during phacoemulsification. A speculum is inserted to hold the eyelids open.

[0128] The physician makes a small incision in the patient's eye at 3130. Before a phacoemulsification or ELT procedure is performed, a small incision is made in the eye to allow for the introduction of surgical instruments. Multiple therapeutic procedures are performed through this small incision during a single surgical procedure.

[0129] The procedure involves administering phacoemulsification (phaco) to the patient. Phacoemulsification is a modern cataract surgery procedure in which the crystalline lens inside the eye is emulsified with an ultrasonic handpiece and then aspirated from the eye. The surgeon removes the anterior surface of the lens capsule that encases the crystalline lens inside the eye. The probe used during phaco is an ultrasonic handpiece with a titanium or steel needle. The tip of the needle vibrates at ultrasonic frequencies and is used to break up and emulsify the cataract. A pump aspirates particles from the tip of the ultrasonic handpiece. In some techniques, another thin steel instrument called a "chopper" is used through a side port to help break up the nucleus into smaller pieces. The cataract is usually broken into two or four pieces, and each piece is emulsified and removed by suction. Emulsifying the nucleus makes it easier to aspirate the particles. After removing the entire hard nucleus in the center of the lens using phacoemulsification, the soft outer lens cortex is removed using suction alone.

[0130] An irrigation and aspiration probe or bimanual system is used to aspirate the remaining peripheral cortical material while leaving the posterior capsule intact. An intraocular lens implant (IOL) is placed within the remaining capsular bag. In some instances, the implant is a polymethyl methacrylate (PMMA) IOL, which requires a widened incision. In some instances, the implant is a silicone or acrylic foldable IOL, which is folded using either a holder, a folding device, or an insertion device provided with the IOL. The IOL is inserted into the posterior chamber within the capsular bag and placed there as an intracapsular implant.

[0131] The procedure includes administering excimer laser trabeculotomy (ELT) treatment 3150 to the patient. In various embodiments, the ELT and cataract surgery are performed through the same corneal incision. In some instances, a physician creates approximately 10 ELT treatment sites on a patient's eye after completing phacoemulsification on the eye.

[0132] Blockage of aqueous humor outflow at the trabecular meshwork and the inner wall of Schlemm's canal is a key cause of elevated IOP (intraocular pressure) in open-angle glaucoma (OAG). In various embodiments, an excimer laser is used to create perforations in Schlemm's canal. Other lasers, such as ruby ​​and argon lasers, are unable to achieve the permanent perforation of the trabecular meshwork necessary to create an internal, rather than an external, outflow channel. While photothermal and photodisruptive lasers were initially successful in perforating the trabecular meshwork, the effect was short-lived due to inflammatory and healing responses. Excimer laser trabeculotomy (ELT) restores the eye's natural aqueous humor outflow without inducing a healing response in the target tissue.

[0133] Excimer laser ablation produces minimal thermal damage, minimizing inflammation and scar tissue formation. The 308 nm xenon chloride ultraviolet excimer laser produces minimal thermal damage compared to visible and infrared lasers. Unlike argon laser trabeculoplasty and selective laser trabeculoplasty, ELT precisely ablates tissue without causing thermal damage or leaving scars on surrounding tissue. Therefore, ELT treatment creates a permanent opening that directly connects the anterior chamber of the eye to Schlemm's canal. To prevent corneal absorption of laser radiation, energy is delivered using optical fiber. A fiber or fiber-optic probe is inserted through an incision and advanced through the anterior chamber until it contacts the trabecular meshwork. A gonioscope or endoscope may be used to allow the physician to visualize the position of the fiber probe.

[0134] The physician delivers pulsed light ablation energy. Typically, the physician creates 10 treatment sites in one or two inferior quadrants. The creation of each opening is confirmed by a small amount of blood reflux from Schlemm's canal. The fiber probe is then removed from the eye. It is noteworthy that IOP immediately decreases after the ELT procedure. Patients are advised to use topical antibiotic and steroid eye drops for one to two weeks after surgery.

[0135] After administering the phaco and ELT treatments, the physician closes the incision at 3160. The incision must be securely closed to prevent endophthalmitis. Typically, physicians use sutures to close the incision. Some physicians suture the incision, while others refrain from suturing in case of persistent leakage. The number of sutures required also depends on the type of IOL implanted during the phaco procedure. For example, foldable IOLs can be inserted through smaller incisions than those required to insert PPMA IOLs, requiring few or no sutures.

[0136] The method of various embodiments includes analyzing 3170 the post-operative results and reporting the results to the patient who underwent surgery and / or scheduling a post-operative follow-up appointment with the patient 3180. For example, the physician's analysis may include checking each opening by observing for a small amount of blood reflux from Schlemm's canal. The physician can then communicate the results to the patient, prescribe post-operative medications such as topical antibiotics and steroid eye drops, and schedule a post-operative follow-up appointment with the patient.

[0137] 11 shows a flowchart of one embodiment 1401 for diagnosing and performing an ELT procedure. As described herein, an ELT procedure can be performed without or in conjunction with phacotherapy. Similarly, embodiment 1401 can be performed regardless of whether phacotherapy has been administered to the patient. Specifically, method 1401 can be used to prophylactically treat a patient to prevent them from developing glaucoma and / or increasing intraocular pressure (IOP).

[0138] Embodiment 1401 includes performing 1402 a pre-operative analysis of a patient, in which the patient is determined to have a congenital risk or is otherwise at high risk for developing glaucoma or elevated IOP. Risk factors that may be considered in the pre-operative analysis of 1402 may include one or more of age, family history, race, sex, and the presence of comorbid conditions (e.g., the presence of a condition associated with a risk of developing glaucoma and / or elevated IOP).

[0139] ELT treatment involves creating a perforation in a patient's trabecular meshwork without significant risk of damaging the tissue surrounding the perforation, and has a relatively high success rate. Therefore, ELT treatment is considered relatively safe, and recovery is usually rapid and without complications. Because of the low risks and often favorable outcomes associated with ELT treatment, ELT procedures can be safely performed on patients who do not yet have glaucoma and / or elevated IOP, but who may be at risk for glaucoma and / or elevated IOP. In other words, because ELT treatment is minimally invasive, more patients with one or more risk factors for glaucoma and / or elevated IOP can undergo ELT treatment without increasing the risk of side effects or treatment failure over time.

[0140] The risk factor evaluated in the preoperative analysis may be one or more risk factors, and if a risk factor (or multiple risk factors) is present, the patient may be considered to be at risk for developing glaucoma and / or elevated IOP. For example, if a patient is over a certain age, the patient may be determined to be at risk for developing glaucoma and / or elevated IOP and therefore be determined to be eligible for ELT treatment in the preoperative analysis. For example, a patient may be considered to be at risk for glaucoma and / or elevated IOP if they are 40 years of age or older, 45 years of age or older, 50 years of age or older, 55 years of age or older, 60 years of age or older, 65 years of age or older, 70 years of age or older, 75 years of age or older, or 80 years of age or older. In various examples, a patient may be considered at risk if they have a congenital risk associated with a high prevalence of glaucoma, for example, if they belong to a particular ethnicity, such as African American or Black, Latin American, South Asian or Indian, or East Asian (e.g., Chinese, Japanese, and / or Korean). Congenital risk may also be determined based on a family history of glaucoma and / or elevated IOP. In various examples, a patient may be considered at risk if they are of a particular gender. In various examples, a patient may be considered at risk if they have other diseases or disorders (e.g., comorbidities), such as elevated intraocular pressure, obesity, diabetes, etc. In various examples, a patient may be considered at risk if they are a tobacco or alcohol user, or if they have been using alcohol or tobacco for a minimum threshold number of years, or if the frequency of their alcohol or tobacco use exceeds a certain threshold.

[0141] At 1404, if it is determined that the patient has sufficient risk factors, congenital or otherwise, for the development of glaucoma and / or elevated IOP, then based on the preoperative analysis and this determination, an ELT procedure may be performed on the patient to prophylactically prevent the development of glaucoma and / or elevated IOP.

[0142] In various embodiments, the pre-operative analysis of 1402 can also include a genetic analysis or genetic testing of the patient. For example, the patient's genetic cellular material (e.g., DNA, RNA) can be sampled and analyzed to look for markers or indicators that the patient is at risk for glaucoma and / or elevated IOP.

[0143] As mentioned above, one risk factor may be race. A particular type of glaucoma, called angle-closure glaucoma, tends to be more prevalent in East Asians (e.g., Chinese, Japanese, and Koreans). Therefore, if a patient is East Asian (with or without identifying other risk factors), they may be at risk for developing angle-closure glaucoma and therefore may be eligible for ELT treatment. Furthermore, certain parts of the patient's eye may be measured or examined (e.g., observing or measuring the lens thickness and / or iris angle of the patient's eye) to determine whether the patient is at risk for developing angle-closure glaucoma. Such parts may indicate a higher risk or symptoms for developing angle-closure glaucoma and, therefore, may be considered risk factors for developing glaucoma and / or elevated IOP.

[0144] Angle-closure glaucoma, also known as angle-closure glaucoma, occurs when the iris of the eye bulges forward, narrowing or blocking the drainage angle formed by the cornea and iris. As a result, fluid cannot circulate through the eye, causing increased intraocular pressure. This is illustrated in Figures 12A and 12B. In Figure 12A, fluid can normally move from below the iris, between the iris and lens, to above the iris, and drain normally through the trabecular meshwork. When fluid can drain normally, IOP can be maintained at an appropriate level.

[0145] FIG. 12B illustrates a closed angle, which can increase IOP and lead to glaucoma. Specifically, the thickening of the lens causes the lens to press against the iris, inhibiting the flow of fluid from below the iris to above the iris. The iris can bulge further, which can further block the drainage channel from the trabecular meshwork. As a result, fluid within the eye may not properly drain, which can lead to elevated IOP and glaucoma. Furthermore, the bulging of the iris, the thickening of the lens, and increased pressure behind the iris can put pressure on Schlemm's canal, where fluid could otherwise drain, thereby reducing the amount of fluid flowing through Schlemm's canal.

[0146] For certain individuals, the eye's lens may continue to grow and thicken with age. Therefore, in preoperative analyses, the risk of angle-closure glaucoma may be associated with certain ethnicities and patients of certain ages. One method for treating angle-closure glaucoma is through phacotherapy. In phacotherapy, the eye's thickened lens is replaced with a thinner artificial lens, reopening the fluid drainage channels between the lens and iris, and potentially between the iris and trabecular meshwork. Thus, phacotherapy can move the iris downward, allowing access to the trabecular meshwork, which may result in a successful ELT procedure. As described herein, it may be desirable to perform phacotherapy and ELT therapy in the same procedure. Therefore, if a patient is identified as at risk for angle-closure glaucoma or is currently being treated for angle-closure glaucoma, it may be advantageous to perform ELT therapy on that patient. This improves fluid drainage from the eye, allowing phacotherapy to be postponed if not already necessary. Alternatively, it may be advantageous to perform ELT and phaco treatments together, as described herein.

[0147] Thus, according to various embodiments described herein, ELT may be performed based on a patient's condition and the patient's existing risk factors, with or without phaco procedures. Risk factors, such as congenital risk factors, may be determined during a preoperative analysis of the patient and their eye to determine whether the patient is at risk for developing glaucoma and / or elevated IOP, whether the patient's IOP is already elevated but the patient has not yet developed glaucoma, etc. In other words, ELT treatment may be administered prophylactically to treat glaucoma even if the patient has not yet been diagnosed with glaucoma and / or does not actually have glaucoma. Similarly, if one or more risk factors have been identified as present in a patient and elevated IOP has not yet been identified in the patient, ELT treatment may still be administered to the patient due to the identified risk factor(s).

[0148] In various embodiments, it may be the case that no specific risk factors are identified. The trabecular meshwork in all human eyes becomes less permeable with age. Therefore, patients who reach a certain age may be treated with the ELT procedure regardless of the presence or absence of specific congenital risk factors. In other words, the ELT procedure may be administered entirely preventatively, even in the absence (or recognition) of any specific risk factors other than age. Thus, the ELT procedure may be used as a preventative measure before a patient's IOP rises or even before any risk factors are identified in the patient.

[0149] FIG. 13 shows a schematic diagram of a system 200 according to various embodiments. The system 200 includes an ELT device 201 and a phaco device 221 communicatively connected to a computer 205. The system 200 optionally includes a server 209 and a storage device 213. The ELT device 201, the phaco device 221, the computer 205, the server 209, and the storage device 213 can exchange data via a communications network 217. When the methods of various embodiments employ a client / server architecture, steps of the methods of various embodiments may be performed using a server, which may include one or more processors and memory, and may retrieve data, instructions, etc., provide results via an interface module, or provide results as a file. The server may be provided by one or more computing devices (such as a rack-mounted computer sold by Hitachi under the trademark BLADE). In the system 200, each computer may include at least one processor coupled to memory and at least one input / output (I / O) mechanism.

[0150] A processor generally includes a chip, such as a single-core chip or a multi-core chip, that provides a central processing unit (CPU). The processor may be provided by an Intel or AMD chip.

[0151] The memory may include one or more machine-readable devices having stored thereon one or more sets of instructions (e.g., software) that, when executed by any one processor(s) of the disclosed computers, may perform some or all of the methods or functions described herein. The computers of various embodiments may include one or more I / O devices, which may include one or more of a visual display unit (e.g., a liquid crystal display (LCD) or cathode ray tube (CRT)), an alphanumeric input device (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive unit, a signal generating device (e.g., a speaker), a touch screen, an accelerometer, a microphone, a cellular radio frequency antenna, and a network interface device (e.g., a network interface card (NIC), a Wi-Fi card, or a cellular modem). System 200 may be used to implement the methods described herein. Instructions for any method steps may be stored in the memory, and the processor may execute those instructions.

[0152] FIG. 14 illustrates a treatment system 300 according to various embodiments. The system 300 can be used to treat multiple eye diseases, such as cataracts and glaucoma. The treatment system 300 includes a phacoemulsification (phaco) system 310 and an excimer laser trabeculotomy (ELT) system 360. The phaco system 310 includes a controller 320, an ultrasound generator 330, an irrigation source and / or pump 340, and an aspiration source and / or pump 350. The phaco system 310 can be housed within a device. An ultrasound probe can be connected to the phaco system and device for use during phaco treatment. The excimer laser system 360 includes a controller 370, an excimer laser 380, and a gas cartridge 390. The excimer laser system 360 can be housed within a housing, and a fiber probe can be connected to the housing for use during ELT treatment.

[0153] FIG. 4 illustrates one embodiment of an excimer laser trabeculotomy (ELT) device 400. The excimer laser is housed in a housing 402. The housing has wheels 404 for portability. A push / pull handle 405 aids in the portability of the ELT device 400. A foot pedal 414 extends from the housing 402 and is operable to provide power for firing shots from the laser through the fiber probes 102, 104. The connectors of the fiber probes 102, 104 connect to the excimer laser in the housing 402 at a fiber connection port 406. The housing includes an interactive user interface 416. In some examples, the interactive user interface 416 displays patient information, machine settings, and treatment information. The housing 402 includes control buttons, switches, and dials, such as a fiber probe cap holder 408, an emergency stop button 410, and a power switch 412.

[0154] FIG. 5 illustrates the fiber probe 500 with a cap. FIG. 6 illustrates one embodiment of the probe 500 with the cap 514 removed to expose the delivery tip 506 of the probe 500. The probe 500 is a single-use, disposable unit. In some embodiments, the fiber probe 500 has a tag that determines its usability. In some instances, a radio frequency identification (RFID) tag must match the RFID of the instrument to operate. The probe 500 generally includes a laser transmitting member and an illumination member, as previously described herein, each connected to a respective source (i.e., the laser source 108 and the light source 110) via a connector 502 (elongated cord) extending from the body of the probe 500, the connector 502 having a connection assembly 504 configured to be received in the connection port 406 of the instrument 400. The probe 500 further includes a delivery tip 506, which is capable of emitting laser energy (from the laser transmitting member) and visible light (from the illumination member). The probe 500 includes a handheld body 508, which may include a finger grip 510 with protrusions or indentations 512. The body 508 of the handheld probe 500 may be made of metal or plastic. A fiber tip 506 at the distal end of the probe includes an optical fiber coated with a metal, such as stainless steel or titanium. The coated fiber at the distal end of the probe is inserted into the trabecular meshwork of the eye. The laser is activated by pressing a foot pedal. When activated, the laser delivers a shot through the optical fiber and into the trabecular meshwork and Schlemm's canal.

[0155] FIG. 15 shows a phaco system or phaco device 800. The phaco device 800 has a housing 910 that houses an ultrasonic generator. The housing 910 is portable and has wheels 920. A foot pedal 930 extends from the housing 910 and is used to deliver energy from the ultrasonic generator to an ultrasonic probe 950. A holder 940 extends from the housing 910 and holds the ultrasonic probe 950 when it is not in use. The ultrasonic probe 950 is connected to the ultrasonic generator via a connector 960. The phaco device includes an interactive display 970 and an additional control device 980. For example, the control device 980 can be a control dial or buttons, and can include a power switch and an emergency stop switch. The interactive display 970 can display the irrigation flow rate, aspiration flow rate, and the frequency and amplitude of the ultrasound waves.

[0156] FIG. 16 shows an ultrasonic probe 1000 for use in phaco. The ultrasonic probe 1000 may also be referred to as a phaco probe, ultrasound probe, or phaco handpiece. The phaco probe connects to a phaco system using a connector 1040, which may be a protective plastic sheath. The protective sheath of the connector 1040 covers an irrigation line 1010, an ultrasound power line 1020, and an aspiration line 1030. The connector 1040 connects the phaco system to a body 1060 of the phaco ultrasonic probe 1000. The body 1060 of the ultrasonic probe 1000 optionally has a finger grip 1050 with a protrusion 1055. The phaco probe is sterilized by any suitable method that provides a sterile instrument suitable for human use. In some embodiments, the phaco probe is disposable. The body 1060 of the ultrasonic probe 1000 has a tip 1070. The tip 1070 includes a needle 1095 and an irrigation sleeve 1085. The needle 1095 is made of titanium or steel. The needle is formed with a beveled tip (e.g., at an angle of 0°, 15°, 30°, or 45° relative to the tip). The phaco needle operates at a frequency of 40 kHz and has an amplitude of 3 / 1000 of an inch. The distal opening of the needle has an aspiration port 1090. The aspiration port 1090 is fluidly coupled to a suction source / pump and then to a drain source. The needle also has one or more irrigation ports 1080. The irrigation ports 1080 are fluidly coupled to an irrigation source / pump. A silicone irrigation sleeve 1085 or silicone material covers the phaco tip and protects the cornea and iris from thermal energy transferred from the probe. In certain examples, the pump used for irrigation and aspiration is selected from a peristaltic pump, a Venturi pump, and a diaphragm pump.

[0157] FIGS. 17-20 illustrate various embodiments of foot pedals. In a specific embodiment, the device includes one foot pedal for phaco therapy and one foot pedal for ELT therapy. The foot pedals have multiple positions. As shown in FIGS. 17-20, there are four positions. As shown in FIG. 17, the foot pedal 1100 is in the initial position when not depressed. In FIG. 18, the foot pedal 1200 is in the first position 1110 and is slightly depressed. In FIG. 19, the foot pedal 1300 is in the second position 1120 and is moderately depressed. In FIG. 20, the foot pedal 1400 is in the third position 1130 and is fully depressed.

[0158] In one embodiment, the foot pedal is used for phaco procedures. When the phaco foot pedal is in a first position, only irrigation is provided. When the phaco foot pedal is in a second position, irrigation and suction are provided. When the phaco foot pedal is in a third position, irrigation and suction are provided, and phaco power is provided.

[0159] In one embodiment, a foot pedal is used for the ELT procedure. Each depression of the foot pedal can result in one shot from the laser. For example, as shown in FIG. 18, when the foot pedal is depressed to a first position, one shot is fired from the laser. As shown in FIG. 19, when the foot pedal is depressed to a second position, one shot is fired from the laser. As shown in FIG. 20, when the foot pedal is depressed to a third position, one shot is fired from the laser. Alternatively, the energy delivered by the foot pedal can increase with position. For example, the first position can fire one shot from the laser, the second position can fire two shots from the laser, and the third position can fire three shots from the laser.

[0160] While FIGS. 4 and 15 depict separate machines / systems for ELT and phaco procedures, according to embodiments described herein, the phaco and ELT systems may also be combined into a single machine. For example, FIG. 21A illustrates a machine 1500 that includes components of both the ELT system of FIG. 4 and the phaco system of FIG. 15. Such a machine may be advantageous because it requires less space in the operating room, thereby providing the operator and anyone else in the operating room with more workspace. Furthermore, such a system may be advantageous because phaco and ELT treatments are both performed on the same patient during the same surgery or procedure, as described herein. Thus, an operator may not need to move between and switch between machines when using a combination machine such as that shown in FIG. 21A.

[0161] The machine 1500 of FIG. 21A shows a single pedal 414 that may be configured to operate and / or work with both the phaco therapy probe 950 and the ELT therapy probes 102, 104. In such an embodiment, the operator may flip a switch or otherwise input to the machine 1500 to indicate whether they are using the ELT probes 102, 104 or the phaco therapy probe 950. In another example, the machine 1500 may be programmed or configured to determine which probe the operator is using. For example, the probe handles may be equipped with touch sensors so that only the probe being held by the operator is operated using the pedal 414. In another example, the probes may also be activated by a button or other switch on the probe in combination with the pedal, such that the pedal controls (e.g., as a safety) only the probe whose button or other switch is pressed or otherwise activated. In another example where the probe is activated by the buttons and pedals 414 on the handle, the buttons on the handle and the pedals can be used for different functions. For example, the pedals can be used to set the power delivered from the laser / probe, and the buttons on the handle can be used to actually deliver the shots of energy according to the pedal settings. This prevents the machine 1500 from accidentally firing a laser for an unused probe, since the button on the probe must still be activated to cause a given laser / probe to fire. In various embodiments, other combination machines for ELT and phaco therapy may have multiple pedals, such as one pedal used for the phaco system / phaco therapy and one pedal used exclusively for the ELT system / ELT therapy.

[0162] FIG. 21B shows another example of a combination ELT / phaco machine 981. This machine 981 may advantageously have only one power cord 982 for connecting to an external power source. The machine 981 may include a phaco unit 983 and an ELT unit 984. The phaco unit 983 and the ELT unit 984 may each be at a convenient height for a user to insert and / or remove probes from the machine. In the example of FIG. 21B, the phaco unit 983 and the ELT unit 984 are at different heights, but are facing toward the top of the machine 981 for easy user access. In other embodiments, the phaco unit 983 and the ELT unit 984 may be positioned at the same height. The ELT unit 984 includes a display 985, a receiver 987 for connecting to the fiber probe, and an energy monitor 988 configured to receive the distal end of the fiber probe so that laser light emitted from the probe can be received by a sensor in the machine 981 to calibrate the laser power emitted from the probe. When inserted into the energy monitor, the distal end of the probe may be attached to a sterile adapter that can be discarded after calibration. This ensures that the distal end of the probe inserted into the eye does not come into contact with the machine 981 or the energy monitor 988. The energy monitor 988 may have a shutter so that the sensor is only exposed when the probe is inserted and the shutter is pushed back. In various embodiments, a single sensor and port for calibrating the laser probe may be used for both the excimer laser for the ELT procedure and the laser and probe used in the phaco procedure. The portion 986 of the machine 981, shown in dashed lines, may include other internal aspects of the machine, such as components for vitrectomy, components for irrigation / aspiration, and delivery systems for both the ELT and phaco lasers. Portion 986 may include or be an access panel to allow inspection and repair of machine 981 as needed.

[0163] In various embodiments, an excimer laser (and any associated components described herein) for performing ELT (e.g., ELT laser, ELT components) may be combined with components other than those associated with a phacoemulsification unit. For example, the excimer or ELT components may be combined with any other components that may be used to treat cataracts or other eye conditions. For example, the excimer or ELT components may be located in the same housing as the femto laser cataract surgery components and powered, for example, from the same cord / outlet. In such an example, the femto laser is used to create an opening in the anterior layer of the eye's lens and also to break up the cataract-containing lens, which is then aspirated. In this manner, the femto laser and aspirating components may be included in the same housing as the excimer or ELT components, similar to the embodiments having the ELT component and phacoemulsification configuration described above. As a result, similar to the embodiments described herein that combine ELT and phaco procedures, femtolaser treatment of cataracts can also be combined with ELT procedures.

[0164] Such machines can conserve space in an operating room and improve efficiency during procedures performed on patients. In various embodiments, an ELT laser can be manufactured to fit into an existing phaco machine (or a phaco machine designed to accommodate other laser components) and incorporated into the phaco machine. Such a process includes inserting the ELT components, securing the ELT components to the phaco machine structure, and connecting the ELT components to the power output or bus of the phaco machine.

[0165] [Excimer laser fiber illumination] In current laser trabeculotomy procedures, surgeons utilize a goniolens, a special contact lens prism held over the eye, in combination with light to allow them to visualize the working end (tip) of the laser fiber as it is positioned against the trabecular meshwork.

[0166] While surgeons have some visibility of the target site (i.e., the trabecular meshwork), the combination of a goniolens and current light sources utilized to illuminate the target site is inadequate. In particular, current procedures utilize an external light beam (from a slit lamp) to illuminate the anterior chamber angle (i.e., the location of the trabecular meshwork) where the cornea and iris meet. However, external light sources are limited in that they may not provide a wide field of view within the eye. As a result, surgeons are unable to reliably visually confirm the position of the laser relative to the trabecular meshwork, the effectiveness of the laser treatment on any portion of the trabecular meshwork, and the drainage of aqueous humor resulting from the laser treatment. For example, without adequate visibility, surgeons may place the laser too close to the trabecular meshwork, too far from the trabecular meshwork, and / or at an improper angle relative to the trabecular meshwork, which can result in unintended collateral tissue damage or the creation of insufficient channels that do not provide the desired drainage. As a result, the laser treatment may be inadequate due to a lack of desired drainage, and the patient may require additional postoperative procedures to reduce intraocular pressure.

[0167] The system of embodiments herein includes a laser probe for performing an intraocular procedure. The laser probe is a single-use, disposable probe that is connected to a laser source and configured to deliver laser energy from the laser source to target tissue to treat the target tissue. The laser probe includes both a laser transmitting member and a light emitting member as a single component. In particular, the laser probe includes an optical fiber core with a delivery tip that transmits (irradiates) laser energy from the laser source to the target tissue during the procedure. The laser probe further includes a light emitting member that illuminates a field of view adjacent the delivery tip of the fiber core, thereby providing a clear view to the surgeon during the laser treatment of the target tissue.

[0168] Laser probes according to various embodiments herein may be particularly suited for laser trabeculotomy procedures. During such procedures, it is crucial for surgeons to have a clear view of the interior of the eye, particularly the anterior chamber angle where the cornea and iris meet, so they can clearly visualize the position of the laser relative to the trabecular meshwork. The surgeon can guide the fiber-optic core delivery tip of the laser probe through a corneal incision in the eye and near the trabecular meshwork. The light-emitting element emits a visible light signal within the eye near the delivery tip, thereby illuminating a field of view within which the surgeon can better visualize the position of the delivery tip and the subsequent delivery of laser energy to the trabecular meshwork. By integrating the illumination element into the laser probe, illumination is provided internally (i.e., within the eye), as opposed to current procedures that utilize external light sources. This provides a much broader field of view within the eye, improving visibility of the target site. The improved visibility allows the surgeon to better position the delivery tip relative to the trabecular meshwork, thereby achieving optimal photoablation and channel formation in the trabecular meshwork and / or Schlemm's canal. The orientation and placement of the delivery tip are particularly important when attempting to achieve optimal channel formation within tissue, particularly when attempting to achieve optimal drainage of the channel placement within the trabecular meshwork relative to Schlemm's canal. Furthermore, by visualizing the drainage of aqueous humor as a result of laser treatment, the surgeon can more reliably visually confirm the effectiveness of the laser treatment.

[0169] In various embodiments herein, an excimer laser probe may be provided for performing an intraocular procedure. The intraocular procedure may include laser trabeculotomy, whereby the target tissue includes the trabecular meshwork and / or Schlemm's canal. However, it should be noted that a laser probe consistent with the present disclosure may be used for any laser treatment of ocular diseases, including, but not limited to, diabetic eye diseases such as proliferative diabetic retinopathy and macular edema, age-related macular degeneration, retinal breaks, and cases of retinopathy of prematurity, as well as for laser in situ keratomileusis (LASIK) to correct refractive errors such as myopia (nearsightedness) and astigmatism.

[0170] The laser probe can include an optical fiber core having a proximal end connectable to an excimer laser source and a distal end including a delivery tip for transmitting (irradiating) laser energy from the excimer laser source to a target tissue for treating the target tissue, and further includes an illumination member for illuminating a field of view adjacent the delivery tip of the fiber core.

[0171] In various embodiments, the illumination member includes an optical fiber for receiving an optical signal from an illumination source that provides an optical signal within the visible light spectrum. Thus, the illumination source may include, but is not limited to, an incandescent light source, a fluorescent light source, a halogen light source, a high-intensity discharge light source, a metal halide light source, and a light-emitting diode (LED) light source.

[0172] In various embodiments, the optical fiber is coaxially aligned with the fiber core. In other embodiments, the optical fiber is adjacent to the fiber core. The laser probe further includes an outer jacket surrounding the optical fiber and the fiber core.

[0173] Another aspect of the various embodiments described herein can be an excimer laser system for performing an intraocular procedure. Again, the intraocular procedure can include laser trabeculotomy, whereby the target tissue includes the trabecular meshwork and / or Schlemm's canal. The excimer laser system includes an excimer laser source, an illumination source, and a disposable, single-use probe, the probe operably connectable to the excimer laser source and the illumination source and configured for use in the intraocular procedure. The laser probe can include an optical fiber core having a proximal end coupleable to the excimer laser source and a distal end including a delivery tip for transmitting (irradiating) laser energy from the excimer laser source to the target tissue to treat the target tissue. The laser probe further includes an illumination member for receiving an illumination signal from the illumination source and illuminating a field of view proximate the delivery tip of the fiber core.

[0174] In various embodiments, the illumination member includes an optical fiber for receiving an optical signal from an illumination source that provides an optical signal within the visible light spectrum. Thus, the illumination source may include, but is not limited to, an incandescent light source, a fluorescent light source, a halogen light source, a high-intensity discharge light source, a metal halide light source, and a light-emitting diode (LED) light source.

[0175] In various embodiments, the optical fiber is coaxially aligned with the fiber core. In other embodiments, the optical fiber is adjacent to the fiber core. The laser probe further includes an outer jacket surrounding the optical fiber and the fiber core.

[0176] In various embodiments, a laser probe may be provided. The laser probe may be a single-use disposable probe that is connected to a laser source and configured to irradiate target tissue with laser energy from the laser source for treatment of the target tissue. The laser probe includes both a laser transmitting member and an illuminating member as a single component. In particular, the laser probe includes an optical fiber core with a delivery tip that transmits (irradiates) laser energy from the laser source to the target tissue during treatment. The laser probe further includes an illuminating member that illuminates a field of view adjacent the delivery tip of the fiber core, thereby providing the surgeon with a clear field of view when laser treating the target tissue.

[0177] The laser probes of various embodiments may be suitable for intraocular procedures in which laser treatment of target tissue is desired. In particular, the laser probes of various embodiments may be used to treat glaucoma and may be useful for performing laser trabeculotomy. However, it should be noted that laser probes consistent with the present disclosure may be used in the laser treatment of any ocular condition, including cases of diabetic eye diseases such as proliferative diabetic retinopathy and macular edema, age-related macular degeneration, retinal breaks, and retinopathy of prematurity, as well as laser in situ keratomileusis (LASIK) to correct refractive errors such as myopia (nearsightedness) and astigmatism.

[0178] During a laser trabeculotomy procedure, it is crucial to have a clear view of the anterior chamber angle, where the cornea and iris meet, so that the surgeon can clearly visualize the position of the laser relative to the trabecular meshwork within the eye. Using a laser probe, the surgeon can guide the laser probe's fiber-optic core delivery tip through a corneal incision in the eye and into the vicinity of the trabecular meshwork. The light-emitting element emits a visible light signal within the eye adjacent to the delivery tip, thereby illuminating a field of view. Within that field of view, the surgeon, with the assistance of a goniolens, can visualize the position of the delivery tip and the subsequent application of laser energy to the trabecular meshwork. By integrating the illumination element into the laser probe, illumination is provided internally (i.e., within the eye), as opposed to current procedures that utilize external light sources. This provides a wider field of view within the eye and improved visibility of the target site. The improved visibility allows the surgeon to better position the delivery tip relative to the trabecular meshwork, thereby achieving optimal photoablation and channel formation in the trabecular meshwork and / or Schlemm's canal. The orientation and position of the delivery tip are particularly important when attempting to achieve optimal channel formation within tissue, particularly when attempting to achieve optimal drainage of the channel placement within the trabecular meshwork relative to Schlemm's canal. Furthermore, visualization of aqueous humor drainage as a result of laser treatment provides the surgeon with a more reliable visual confirmation of the effectiveness of the laser treatment.

[0179] As previously mentioned, Figure 4 illustrates one embodiment of the excimer laser system 100. Figure 5 illustrates one embodiment of a probe 500 for use with the excimer laser system 100, illustrating the probe 500 having a capped distal delivery tip 506. Figure 6 illustrates one embodiment of the probe 500 with the cap 514 removed, exposing the delivery tip 506 of the probe 500.

[0180] 22 and 23 show cross-sectional views of the probe 500 taken along lines AA and BB, respectively, of FIG. 6 . As shown, the laser transmission member may include an optical fiber core 518 that extends through the fiber probe 500 and forms part of the connector 502. Similarly, the illumination member may include an optical fiber 520 that extends through the fiber probe 500 and forms part of the connector 502. A protective sheath 516 surrounds the optical fiber core 518 and the optical fiber 520. In some examples, the protective sheath 516 is a plastic or rubber protective sheath. The optical fiber core 518 and the optical fiber 520 further form part of the delivery tip 506 of the probe 500. A metal jacket 522 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, a stainless steel jacket 522 surrounds and protects the optical fiber core 518 and the optical fiber 520. As shown, in some embodiments, the optical fiber 520 is coaxially disposed with and surrounds the optical fiber core 518. Alternatively, in other embodiments, core 518 may surround fiber 520. In other embodiments, optical fiber 520 is adjacent to optical fiber core 518.

[0181] FIG. 24 shows an enlarged view of the delivery tip 502 of the probe 500, which emits visible light (emitted from the optical fiber 520 in response to receiving an optical signal from the light source 110) and laser energy (emitted from the optical fiber core 518 in response to receiving a laser pulse from the laser source 108) for photoablation of target tissue.

[0182] FIGS. 25 and 26 show an alternative embodiment of the probe, showing cross-sections 530 and 536, respectively, taken along lines AA and BB of FIG. 6, which are cross-sections similar to FIGS. 22 and 23 of the probe 500. As shown, the laser transmission member extends through the fiber probe 500 and can include an optical fiber core 534 that forms part of the connector 502. In this embodiment, visible light from the light source 110 of the laser system 100 can be delivered through the optical fiber core 534 along with a laser used to treat glaucoma. That is, in various embodiments, the laser system 100 may not have a separate illumination member 104 within the probe member 102. Rather, the probe member 102 can have a single optical fiber core (e.g., optical fiber core 534) through which both excimer laser light and visible light for illuminating a treatment site within the eye can pass. Because the visible light and the excimer laser light have different wavelengths, they can pass through the optical fiber core 534 without interfering with each other, or they interfere slightly enough that it does not affect the use of the excimer laser for treating the eye. In this way, both the excimer laser light and the visible light can pass through the single optical fiber core 534 .

[0183] In addition to the cost savings of the probe and the optical fiber therein due to having one optical fiber instead of two, the connector 502 (elongated cord) attached to the probe may be easier to manipulate due to having only one optical fiber therein instead of two. Such a configuration allows the connector 502 (elongated cord) to bend more easily, reducing the diameter and weight of the connector 502. Furthermore, the visible light output at the delivery tip 502 of the probe 500 can be positioned closer to the site where the laser is being applied for laser trabeculotomy treatment. In this way, light emitted from the single optical fiber core 534, through which both the excimer laser light and visible light pass, can more efficiently illuminate the treatment site within the eye. In FIG. 25 , a protective sheath or metal jacket 532 may surround the optical fiber core 534. In some examples, the protective sheath 532 is a plastic or rubber protective sheath. In FIG. 26 , a protective sheath or metal jacket 538 may surround the optical fiber core 534. In various embodiments, the protective sheath or metal jacket 532 may be a stainless steel jacket that surrounds and protects the optical fiber core 534. As shown, in various embodiments, the protective sheath or metal jacket 532 is coaxially disposed with the optical fiber core 534. Thus, the protective sheath or metal jacket 532 is adjacent to the optical fiber core 534.

[0184] In various embodiments, different types of light may be used. For example, visible white light may be used while the fiber probe is approaching the trabecular meshwork, before the fiber probe contacts the trabecular meshwork tissue, to illuminate the trabecular meshwork angle structures for better visibility. Visible white light may also illuminate tissue in front of the fiber probe's delivery tip while the probe is in contact with the tissue, such as the trabecular meshwork. In various embodiments, specific wavelengths of visible light may be used in addition to or instead of visible white light. For example, when a wavelength of light that is highly absorbed by blood is used, the operator may more easily identify and / or visualize Schlemm's canal and other blood vessels within the eye. Similarly, light with a wavelength that is not well absorbed by blood may be used to visualize blood structures (e.g., a sort of inverted (negative) image of the image shown when light highly absorbed by blood is used). Such wavelengths may provide the operator with better visibility of ocular tissue, including blood vessels and other tissue that are not on the surface of the eye.

[0185] Laser probes may be well suited for intraocular procedures in which laser treatment of target tissue is desired. In particular, laser probes may be used to treat glaucoma and may be useful for performing laser trabeculotomy. However, it should be noted that laser probes consistent with the present disclosure may be used in any laser treatment of eye disorders, including, but not limited to, diabetic eye diseases such as proliferative diabetic retinopathy and macular edema, age-related macular degeneration, retinal breaks, and cases of retinopathy of prematurity, as well as laser in situ keratomileusis (LASIK) to correct refractive errors such as myopia (nearsightedness) and astigmatism.

[0186] During a laser trabeculotomy procedure, it is crucial to have a clear view of the anterior chamber angle, where the cornea and iris meet, so that the surgeon can clearly visualize the position of the laser relative to the trabecular meshwork within the eye. Using a laser probe, the surgeon can guide the laser probe's fiber-optic core delivery tip through a corneal incision in the eye and into the vicinity of the trabecular meshwork. The light-emitting element emits a visible light signal within the eye adjacent to the delivery tip, thereby illuminating a field of view. Within that field of view, the surgeon, with the assistance of a goniolens, can visualize the placement of the delivery tip and the subsequent delivery of laser energy to the trabecular meshwork. By integrating the illumination element into the laser probe, illumination is provided internally (i.e., within the eye), as opposed to current procedures that utilize external light sources. This provides a wider field of view within the eye and improves visibility of the target site. The improved visibility allows the surgeon to better position the delivery tip relative to the trabecular meshwork, thereby achieving optimal photoablation and channel formation in the trabecular meshwork and / or Schlemm's canal. The orientation and position of the delivery tip are particularly important when attempting to achieve optimal channel formation in tissue, particularly when attempting to achieve optimal drainage of the channel placement within the trabecular meshwork relative to Schlemm's canal. Furthermore, visualization of aqueous humor drainage as a result of laser treatment allows the surgeon to more reliably visually confirm the effectiveness of the laser treatment.

[0187] [Authentication system and authentication method for excimer laser systems] The medical industry is home to many surgical devices, instruments, and systems that are comprised of individual components that must work together properly to ensure that treatment is performed safely and as intended. For example, medical laser systems are used to treat a variety of conditions in various medical specialties (i.e., urology, neurology, otorhinolaryngology, ophthalmology under general anesthesia, dentistry, gastroenterology, cardiology, gynecology, and thoracic and orthopedic procedures). Medical laser systems consist of a laser unit that generates laser radiation and a separate laser probe having an optical fiber and adapted to direct the laser radiation from the laser through the optical fiber to the treatment site.

[0188] Certain components of a laser system may be designed by manufacturers to be used with other specific components. For example, a variety of medical optical fibers are available on the market that can be used with laser systems. Currently, available laser systems can provide laser light at various wavelengths and therefore can be used for specific purposes and procedures. Accordingly, the optical fibers used with these laser systems may have various sizes (diameter, length, etc.), be made from various materials, operate at various temperatures, operate at various wavelengths, and have physical properties (e.g., bend radius). Certain components of a laser system may be designed by manufacturers to be used with other specific components. For example, a wide variety of medical optical fibers are available on the market that can be used with laser systems used in medical procedures. Furthermore, manufacturers of certain components may also manufacture other components of a laser system or may certify (certify) that these other components are compatible with their own components.

[0189] Before beginning a medical procedure, it is important that the appropriate optical fiber is connected to the laser unit being used for the medical procedure. Laser unit manufacturers often recommend the use of a specific brand and / or specific optical fiber with their laser units. If any of the components used are not certified (qualified), the system may not function to its full potential or may even malfunction, endangering patient safety. For example, using an inappropriate optical fiber could result in damage to the equipment, delay the medical procedure until the appropriate optical fiber is available, and / or result in an ineffective, damaging, or potentially life-threatening medical procedure.

[0190] Various embodiments provide a system for authenticating a laser probe for use with a laser system. In such a system, the components generally include a laser unit and single-use, disposable laser probe(s) coupled to the laser unit, each having an optical fiber and adapted to direct laser radiation (laser light) from the laser unit through the fiber to a treatment site. The laser unit includes a control system for operating the laser unit, the control system including controlling the output of laser radiation to the laser probe coupled to the laser unit. The laser unit further includes structure(s) configured to authenticate any given laser probe to determine whether the laser probe is appropriate and / or authorized to operate with the laser unit. In particular, the laser unit includes an RFID reader for reading data embedded in an RFID tag associated with the laser probe upon attachment of the laser probe to the laser unit. The data from the RFID tag is analyzed by the control system to determine whether the laser probe is authentic (i.e., appropriate for use with the laser unit). If the laser probe is determined to be authentic, the control system allows the transmission of laser radiation to the laser probe, thereby allowing the laser probe to perform a procedure, and if the laser probe is determined to be inauthentic, the control system blocks the transmission of laser radiation to the laser probe.

[0191] The authentication analysis is based on a correlation between the RFID tag data and known, predefined authentication data stored in a database locally within the laser unit or in a remote database. The known, predefined authentication data is controlled by the owner / manufacturer of the laser unit, who can determine which laser probes are used with the laser unit. The owner / manufacturer can set a specific authentication key or provide a specific identification number unique to the owner / manufacturer. Thus, to be considered authentic, the RFID tag data for any given laser probe must contain the corresponding unique identifier (i.e., the authentication key or identification number). The RFID tag data may also include other information and / or characteristics related to the laser probe and optical fiber. For example, in some embodiments, the RFID tag data further includes operational history information for the laser probe. Thus, in some embodiments, a control system can be used to deauthorize a laser probe based on its operational history. For example, a laser probe may be deauthorized if it has already been used or if the maximum number of recommended laser pulses has been reached, preventing further use of the laser probe with the laser unit.

[0192] Thus, the authentication system of various embodiments ensures that only authorized laser probes can be used with a laser unit. This authentication ensures that only laser probes recommended and authorized by the manufacturer are used, thereby ensuring that the laser system functions as intended and patient safety is maintained. Additionally, authentication prevents the use of counterfeit components. As counterfeit unique components become more prevalent, the need to authenticate original products becomes increasingly necessary. By embedding RFID directly within the laser probe and utilizing RFID technology for authentication, manufacturers can thwart counterfeiters and secure recurring revenue streams that could otherwise be lost to counterfeit products.

[0193] Various embodiments provide a system for authenticating a laser probe for use with a laser system. In such a system, the components generally include a laser unit and single-use, disposable laser probe(s) coupled to the laser unit, each having an optical fiber and adapted to direct laser radiation (laser light) from the laser unit through the fiber to a treatment site. The laser unit includes a control system for operating the laser unit, the control system including controlling the output of laser radiation to the laser probe coupled to the laser unit. The laser unit further includes structure(s) configured to authenticate any given laser probe to determine whether the laser probe is appropriate and / or authorized to operate with the laser unit. In particular, the laser unit includes an RFID reader for reading data embedded in an RFID tag associated with the laser probe upon attachment of the laser probe to the laser unit. The data from the RFID tag is analyzed by the control system to determine whether the laser probe is authentic (i.e., appropriate for use with the laser unit). If the laser probe is determined to be authentic, the control system allows the transmission of laser radiation to the laser probe, thereby allowing the laser probe to perform a procedure, and if the laser probe is determined to be inauthentic, the control system blocks the transmission of laser radiation to the laser probe.

[0194] Thus, the authentication system of various embodiments ensures that only authorized laser probes can be used with a laser unit. This authentication ensures that only laser probes recommended and authorized by the manufacturer are used, thereby ensuring that the laser system functions as intended and patient safety is maintained. Additionally, authentication prevents the use of counterfeit components. As counterfeit unique components become more prevalent, the need to authenticate original products becomes increasingly necessary. By embedding RFID directly within the laser probe and utilizing RFID technology for authentication, manufacturers can thwart counterfeiters and secure recurring revenue streams that could otherwise be lost to counterfeit products.

[0195] The laser units and laser probes of various embodiments may be suitable for intraocular procedures in which laser treatment of target tissue is desired. In particular, the laser probes and laser units of various embodiments are used to treat glaucoma and are useful when performing laser trabeculotomy. However, it should be noted that laser probes consistent with the present disclosure may be used in any laser treatment of a variety of conditions, including other eye conditions (i.e., diabetic eye diseases such as proliferative diabetic retinopathy and macular edema, age-related macular degeneration, retinal breaks, and cases of retinopathy of prematurity, as well as laser in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) and astigmatism), as well as other conditions in other general and other medical fields (outside of ophthalmology).

[0196] FIG. 27 illustrates an excimer laser system including a laser unit system 4100 and a laser probe 4200 attached to the laser unit system 4100. The system 4100 includes an RFID reader 4102, a controller 4104 (also referred to herein as a "control system 4104"), and a laser source 4106. The laser probe 4200 includes an RFID tag 4202 and a fiber core 4204. As described in more detail herein, many of the components of the laser unit system 4100 are housed in a housing, such as a movable platform located in the premises where the procedure is performed (e.g., an operating room, treatment room, outpatient clinic, etc.), and the probe 4200 can be connected to the housing for use during treatment. When the probe 4200 is connected to the housing, the fiber core 4204 is adapted to connect to the laser source 4106 and direct laser radiation (laser light) from the laser source 4106 through the fiber to the treatment site.

[0197] The laser source 4106 can include an excimer laser 4108 and a gas cartridge 4110 that provides the appropriate gas combination to the laser 4106. The excimer laser 4106 is a type of ultraviolet laser, which generally operates in the UV spectral region and generates nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cartridge 4110) is generally a gas mixture containing a noble gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high pressure, pseudo-molecules called excimers (or exciplexes, in the case of noble gas halides) are created that can only exist in an excited state and generate laser light in the UV range.

[0198] Laser action in excimer molecules occurs because the excimer molecules have a bonded (associative) excited state but a repulsive (dissociative) ground state. Noble gases, such as xenon and krypton, are highly inert and do not normally form compounds. However, when in an excited state (induced by an electric discharge or a high-energy electron beam), noble gases can form temporarily bonded molecules with themselves (excimers) or with halogens, such as fluorine or chlorine (exciplexes). The excited compounds release excess energy through spontaneous or stimulated emission, resulting in highly repulsive ground-state molecules that very rapidly (on the order of picoseconds) dissociate back into two unbonded atoms, forming a population inversion. The excimer laser 4108 in this system 4100 is a XeCl excimer laser emitting at a wavelength of 308 nm.

[0199] The controller 4104 allows an operator (i.e., a surgeon or other medical professional) to control the output of the laser signal (from the laser source 4106 to the fiber core 4204), and thus the transmission of laser energy from the fiber core 4204 of the probe 4200. However, before providing the operator with control over the laser output, the laser probe 4200 undergoes an authentication procedure to determine whether the laser probe 4200 is appropriate for use with the laser unit system 100. In particular, upon coupling the laser probe 4200 to the system 4100, the RFID reader 4102 reads data embedded in the RFID tag 4202 of the laser probe 4200, and such RFID tag data is analyzed to determine the authenticity of the laser probe 4200.

[0200] 28 is a diagram illustrating authentication of the laser system 4100 and the laser probe 4200 used with the laser system 4100. Data from the RFID tag is read by an RFID reader and then analyzed by the controller 4104. Based on the authentication analysis, it is determined whether the laser probe is authentic (i.e., appropriate for use with the laser unit). If the laser probe is determined to be authentic, the controller 104 enables transmission of laser light to the laser probe 4200, and the laser probe 4200 can be used to perform a procedure. If the laser probe is determined to be inauthentic, the controller 4104 blocks transmission of laser light to the laser probe 4200.

[0201] The controller 4104 may include software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions, or instruction sets, and / or data in a memory device. As used in any embodiment herein, "circuitry" may include, alone or in any combination, hardwired circuitry, programmable circuitry such as a computer processor including one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by the programmable circuitry. For example, the controller 4104 may include a hardware processor coupled to a non-transitory computer-readable memory that includes instructions executable by the processor to cause the controller to perform various functions of the laser system 4100 described herein, including controlling the laser and / or illumination output.

[0202] The authentication analysis is based on correlation of the RFID tag data with known predefined authentication data stored in a database, either a local database forming part of the laser unit system 4100 (i.e., probe database 4114) or a remote database hosted via a remote server 4300 (i.e., probe database 4302). For example, in some embodiments, the system 4100 can communicate and exchange data with the remote server 4300 over a network. The network can refer to, for example, a private or non-private local area network (LAN), a personal area network (PAN), a storage area network (SAN), a backbone network, a global area network (GAN), a wide area network (WAN), or any such collection of computer networks, such as an intranet, an extranet, or the Internet (i.e., a global system of interconnected networks on which various applications or services run, including, for example, the World Wide Web).

[0203] The known predefined authentication data stored in a database (database 4114 or database 4302) may be controlled, for example, by the owner / manufacturer of laser unit 4100, who may determine which laser probes may be used with the laser unit. For example, the owner / manufacturer may set a specific authentication key or provide a specific identification number unique to the owner / manufacturer. Thus, to be considered authentic, the RFID tag data for any given laser probe must contain the corresponding unique identifier (i.e., authentication key or identification number).

[0204] One approach to uniquely identifying a laser probe is to authenticate the probe through the use of a private key. In such an approach, the same key is learned by both the laser system 4100 and the RFID tag 4202. The RFID tag 4202 and laser system 4100 then work together to authenticate the key. More specifically, the laser system 4100 generates a random, unique challenge number. The RFID tag 4202 uses this challenge and, in combination with the key, generates an authentication code response. The method for generating this code (known as a hash function) masks the value of the key. Another approach to uniquely identifying a laser probe is to use a unique, unalterable identification number. This approach can be used when there is an area of ​​memory (e.g., serial number or model number) that can only be written by the RFID manufacturer. This protection is achieved by ensuring that manufacturers only provide tags with legal identification numbers, preventing simple cloning of legitimate tags.

[0205] The RFID tag data may include other information and / or characteristics related to the laser probe and optical fiber. For example, in some embodiments, the RFID tag data further includes operational history information for the laser probe. Thus, in some embodiments, the controller 4104 may be used to deauthorize the laser probe based on its operational history. For example, the controller 4104 may deauthorize the laser probe if it has already been used or if it has reached a maximum number of recommended laser pulses, thereby preventing further use of the laser probe with its laser unit.

[0206] As commonly understood, RFID technology uses electromagnetic fields to automatically identify and track tags attached to objects. As mentioned above, the RFID tag associated with a laser probe contains electronically stored information. RFID tags may be read-only, with a factory-assigned serial number used as a key to a database, or read / write, allowing system users to write object-specific data to the tag. Field-programmable tags may be write-once, read-multiple, or "blank" tags may be written by users with electronic product codes. RFID tags contain at least three parts: an integrated circuit that stores and processes information and modulates and demodulates radio frequency (RF) signals; a sensor configured to collect DC power from an incident reader signal; and an antenna that receives and transmits signals. Tag information is stored in non-volatile memory. RFID tags contain fixed or programmable logic that processes the transmitted information and sensor data, respectively.

[0207] An RFID reader transmits a coded radio signal to interrogate the tag. The RFID tag receives the message and responds with its own identifying and other information. This may be just the tag's unique serial number, or product-related information such as inventory number, lot number, batch number, manufacturing date, or other specific information. Because tags have individual serial numbers, RFID system designs can identify and simultaneously read multiple tags that may be within range of the RFID reader.

[0208] In some embodiments, the RFID tag may be a passive tag that collects energy from the interrogating radio waves of the laser system's RFID reader. In some embodiments, the RFID tag may be an active tag that includes a local power source (e.g., a battery) and can operate hundreds of meters away from the laser system's RFID reader. FIG. 4 shows an example of an excimer laser unit that may be used in accordance with various embodiments. The RFID reader 4102, controller 4104, and laser source 4106 may be housed in a housing 402. Note that the RFID reader 4102 may be positioned near the connection port 406 so that it can read data from the RFID tag 4202 located at the connection end of the laser probe 4200.

[0209] Figure 29 shows an embodiment of the probe 500 similar to Figure 6, except that the connection assembly additionally includes an RFID tag, which is embedded in or attached to the connection assembly. For example, an RFID tag 4202 is provided on the connection assembly 504, and when the connection assembly 504 is connected to the connection port 406 of the laser unit system 100, data embedded in the RFID tag 4202 can be read by the RFID reader 4102.

[0210] 30 and 31 show cross-sectional views of the probe 500 taken along lines AA and BB, respectively, of FIG. 29. As shown, an optical fiber core 518 extends through the probe 500 and forms part of the connector 502. A protective sheath 516 surrounds the optical fiber core 518. In some examples, the protective sheath 516 is a plastic or rubber protective sheath. The optical fiber core 518 also forms part of the delivery tip 506 of the probe 500. A metal jacket 520 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, a stainless steel jacket 520 surrounds and protects the optical fiber core 518.

[0211] FIG. 32 illustrates one embodiment of a laser probe 500 attached to the laser unit system 100. As described above, when the laser probe 500 is attached to the system 100 (i.e., when the connection assembly 504 of the probe 500 connects with the connection port 406 of the system 400), the RFID reader 4102 reads data embedded in the RFID tag associated with the connection assembly 504. FIG. 33 illustrates a close-up view of the connection between the laser probe 500 and the system 4100 and the initial RFID read to determine the authenticity of the laser probe 4200. The data from the RFID tag is analyzed by the controller 4104 to determine whether the laser probe is authentic (i.e., appropriate for use with the laser unit). If the laser probe 4200 is determined to be authentic, the controller enables transmission of laser light to the laser probe 4200. If the laser probe 4200 is determined to be inauthentic, the controller 4104 blocks transmission of laser light to the laser probe.

[0212] Thus, the authentication system of various embodiments ensures that only authorized laser probes can be used with the laser unit. This authentication ensures that only laser probes recommended and authorized by the manufacturer are used, thereby ensuring that the laser system functions as intended and patient safety is maintained. This authentication also prevents the use of counterfeit components. As counterfeit unique components become more prevalent, the need to authenticate original products becomes increasingly necessary. By embedding RFID directly into the laser probe and utilizing RFID technology for authentication, manufacturers can thwart counterfeiters and secure a recurring revenue stream that could otherwise be lost to counterfeit products.

[0213] Figures 34 and 35 show further examples of methods for authenticating a probe for use with an excimer laser unit for ELT treatment. Figure 34 is a flow chart of one embodiment of a method for authenticating a probe for use with an excimer laser unit. Figure 35 is a flow chart of an embodiment for preventing the use of unauthorized probes.

[0214] At 3402, a probe may be connected to an ELT machine. The probe may have an RFID tag or other readable sensor or memory. The memory may contain data used to authenticate the probe. At 3404, the authentication data stored on the probe may be read, for example, by a reader on the ELT machine. At 3406, the authentication data may be determined to be valid, for example, by a processor on the ELT machine. In various embodiments, if the ELT machine is connected to a network of other computing devices, a processor on another device (e.g., a remote server) may be used to determine whether the authentication data is valid. The authentication data may be encrypted or otherwise encoded so that the authentication data can be decrypted or deciphered before determining its validity. The data stored on the probe may indicate other information in addition to simply its validity or invalidity. For example, the probe data may indicate the country, city, or facility of origin (e.g., where the probe was made), the type of probe, the brand name or trademark of the probe, the type of material used in the probe, the identity of the probe purchaser, the identity of the probe manufacturer, etc. Thus, the ELT machine (using its own processor or via another computing device) can determine various information about the probe that is stored in the probe. In various embodiments, the probe can determine the validity of the probe based on a lookup table or other database of probe information. For example, the lookup table or database may include information about valid and invalid probes, etc. If the authentication data matches data stored in a lookup table or database associated with a valid probe, the probe may be considered valid. The lookup table may be stored in memory on the ELT machine or in memory on another computing device connected to the ELT machine via a network.

[0215] If the probe is authenticated in 3406, then the probe can be used in ELT therapy in 3408. The probe can be used according to additional data stored in the probe, or other determinations about the probe can be made based on the data stored in the probe. For example, the data stored in the probe can indicate how much total energy can pass through the probe without significant degradation, how many total shots can be used with the probe, what wavelength of energy should be used with the probe, and / or any other characteristics related to the use of the probe. In various embodiments, instead of storing such data in the probe, the ELT machine or another computing device can identify the probe as a particular type of probe based on the data stored in the probe. In such embodiments, the ELT machine or other computing device can then determine additional information about how to use the probe (e.g., total energy, number of shots, wavelength, etc.) based on the type of probe attached. Such information can be further stored in a lookup table or database, allowing authentication to occur simultaneously with identifying other characteristics of the probe, which do not need to be specifically stored in the probe itself. Such lookup tables or databases may be updated from time to time with information about new probes as they are manufactured so that the ELT machine can properly determine whether a probe is valid. Such updates may occur over a network such as the Internet.

[0216] In 3410, the authentication data on the probe is modified (e.g., data stored in the probe's memory is erased, changed, overwritten, or added), thereby invalidating the authentication data. In other words, the probe's data may be altered in some way such that if the probe is reconnected to this or another ELT machine, the ELT machine will determine the probe is invalid and will not allow it to be used. This prevents the use of probes not manufactured by a trusted manufacturer, probes that have already been used, or probes that have been tampered with. Similarly, if the ELT machine cannot find the probe's data (e.g., the probe lacks an RFID tag, memory, or the like), the ELT machine can determine the probe is invalid and prevent its use. This method protects patients because counterfeit probes may not have been manufactured properly and could cause an accident that could damage a patient's eye. Similarly, previously used probes may be ineffective or dangerous if used on a patient because the optical fiber within the probe may have deteriorated since use.

[0217] While the embodiment described with respect to FIG. 34 relates to a probe having memory that can be modified by an ELT machine, other embodiments for verifying probe validity are also contemplated herein. For example, a probe's memory or RFID tag may store static code or data. The ELT machine can read that data from the probe and check a database or lookup table to determine if the particular probe has been used before and / or determine if the data on the probe is valid. If the data is valid and the lookup table or database does not indicate that the probe has been used before, the probe can be used with the ELT machine. Once the probe is used, the processor of the ELT machine or another computing device can update the lookup table or database to indicate that the particular probe associated with the data read from the probe has been used. If the ELT machine or another ELT machine subsequently reads data from that probe again, it may determine from the lookup table or database that the probe has already been used, and the probe will not be authorized for use with the ELT machine.

[0218] 35 illustrates a method 3500 in which a probe is determined to be invalid. At 3502, it is determined (e.g., based on data stored in the probe) that an invalid probe is connected to an ELT machine. At 3504, the ELT machine or a computing device associated with the ELT machine displays in an interface that the probe is invalid. As such, the probe cannot be used with the ELT machine. In various embodiments, method 3500 may end after 3504.

[0219] In other embodiments, it may be determined at 3506 that a predetermined threshold number of invalid probes have been attempted to be used with the ELT machine. That is, if a certain number of invalid probes have been attempted, the machine may determine whether it has met or exceeded a certain threshold number. The threshold number may be set, for example, by the manufacturer of the ELT machine. After determining that the threshold number has been exceeded, the interface may display at 3508 that the ELT machine is disabled, not working, or has otherwise failed. Optionally, other information may be displayed, such as instructing the operator to have the ELT machine serviced or instructing the operator that excessive use of invalid probes requires manufacturer personnel to reset the machine. In various embodiments, for example, if the ELT machine is connected to a network, an alert or message may be sent to a computing device controlled by or associated with the ELT machine manufacturer or another party other than the operator of the ELT machine, thereby alerting the manufacturer or other party to the attempted use of an invalid probe. Similarly, an alert or message may be sent only if an attempt is made to use an invalid probe that has reached a predetermined threshold number of times, which may be the same as or different from the threshold number that triggers disabling of the ELT machine. In 3510, the ELT machine itself may be disabled based on reaching or exceeding the threshold number of times. In this manner, patients may be protected from operators attempting to repeatedly use invalid probes in ophthalmic procedures.

[0220] As used in any embodiment herein, the term “module” may refer to software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, an instruction set, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions, or an instruction set, and / or data in a memory device. “Circuitry,” as used in any embodiment herein, may include, alone or in any combination, hardwired circuitry, programmable circuitry such as a computer processor including one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by a programmable circuit. Modules may collectively or individually be embodied as circuits that form part of a larger system, e.g., an integrated circuit (IC), a system-on-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc.

[0221] Any of the operations described herein may be implemented in a system that includes one or more storage media having stored thereon, individually or in combination, instructions that, when executed by one or more processors, perform the methods described above, where the processors may include, for example, server CPUs, mobile device CPUs, and / or other programmable circuitry.

[0222] It is also contemplated that the operations described herein may be distributed across multiple physical devices, such as processing structures in two or more different physical locations. The storage medium may include any type of tangible medium, such as any type of disk, including hard disks, floppy disks, optical disks, compact disk-read-only memory (CD-ROM), compact disk-rewriteable (CD-RW), and magneto-optical disks, read-only memory (ROM), random access memory (RAM) such as dynamic RAM and static RAM, erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, semiconductor devices such as solid-state disks (SSD), magnetic or optical cards, or any type of medium suitable for storing electronic instructions. Other embodiments may be implemented as software modules executed by a programmable control device. The storage medium may be non-transitory.

[0223] As described herein, various embodiments may be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, etc.), integrated circuits, application specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chipsets, etc.

[0224] Throughout this specification, when "one embodiment" or "an embodiment" is referenced, it means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0225] The term "non-transitory" should be understood to exclude only transitory propagating signals per se from the claims, and does not disclaim all standard computer-readable media other than transitory propagating signals per se. In other words, the terms "non-transitory computer-readable medium" and "non-transitory computer-readable storage medium" should be interpreted to exclude only transitory computer-readable media of the type determined in In Re Nuijiten to be outside the scope of patentable subject matter under 35 U.S.C. § 101.

[0226] The terms and expressions used in this specification are used for purposes of description rather than limitation, and in the use of such terms and expressions there is no intention to exclude any equivalents of the features (or portions thereof) shown and described, recognizing that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to encompass all such equivalents.

[0227] Calibration system for mitigating manufacturing tolerances of optical fibers in excimer lasers. The medical industry is home to many surgical devices, instruments, and systems that are made up of individual components that must work together properly to ensure that treatment is performed safely and effectively. It is extremely important that any given component be within acceptable tolerances to ensure that it physically fits with other components, interacts properly with them, and functions as intended.

[0228] The actual manufacturing of a product (or the operation of a system) involves some inherent variation in inputs and outputs. Also, all measurements have measurement error and statistical uncertainty. Therefore, tolerances are an essential element when designing a device, equipment, or system. The concept of tolerance, also known as engineering tolerance, relates to the allowable limits of variation (variation) in the physical dimensions of a component, the measurements or physical properties of a component, the spacing between one component and another, etc. Therefore, if a component falls outside the allowable tolerance (i.e., if the component is too small, too large, or does not have the acceptable characteristics), the entire device, equipment, or system will not function as designed.

[0229] One example of a surgical system composed of multiple components is a medical laser system. Medical laser systems generally consist of a laser unit and a separate laser probe with an optical fiber that directs laser radiation (laser light) from the laser unit to a treatment site. The laser unit may be designed to provide laser light at a specific wavelength and perform a specific treatment. For example, one treatment may require photocoagulation of target tissue caused by irradiation with laser light at a first wavelength, while another treatment may require photoablation of target tissue caused by irradiation with laser light at a second wavelength. Additionally, the optical fibers used with these laser systems may have specific dimensions, material compositions, and / or functional characteristics (i.e., operation at specific temperatures and wavelengths) to function as intended with the corresponding laser unit.

[0230] While current laser units tolerate some tolerance (i.e., the dimensions, properties, or conditions of the optical fiber can vary to a degree that does not significantly affect the function of the laser system), the tolerance range is very narrow. For example, optical fibers typically have very small diameters measured on the micron scale. The diameter of the optical fiber can affect the transmission of laser light through the optical fiber and, in turn, the laser light emitted from the delivery tip of the optical fiber. Therefore, there is very little room for variation in the manufacturing of optical fibers. Manufacturing costs increase as a result of the high precision required to ensure that the diameter of the optical fiber falls within the tolerance. Furthermore, if a given optical fiber falls outside the tolerance (i.e., the diameter is too large or too small), the use of that mismatched optical fiber may result in the transmission of laser light at a wavelength that is not the desired wavelength. As a result, the use of a mismatched optical fiber risks providing ineffective treatment and, in some cases, may cause unintended damage and harm.

[0231] Various embodiments provide a system for calibrating output from a laser source to compensate for increased variations in the laser optical fiber. In such a system, the elements generally include a laser source that generates laser energy that is provided to one of a plurality of laser probes that are coupleable to the laser source. Each laser probe includes an optical fiber having an optical fiber core and is adapted to direct laser light from the laser source through the fiber to a desired treatment site. The system further includes a laser management system for managing the laser source. The management system includes a control system that adjusts the laser energy output from the laser source to any given laser probe to maintain a constant level of laser light irradiated at the target site despite variations in the optical fiber core of any given laser probe.

[0232] More specifically, as part of the initial setup, the control system receives data related to the laser probe coupled to the laser source. The data may include one or more dimensions of the laser probe's optical fiber core, including the diameter of the optical fiber core. The data is then analyzed by the controller, and an optimal level of laser energy output from the laser source is determined based on the analysis. The optimal level of laser energy output from the laser source is based on a correlation between the laser probe data, such as the specific dimensions of the optical fiber core, and calibration data. The calibration data may generally include multiple value sets, each value set including a laser energy output level from the laser source, a diameter of the optical fiber core of the laser probe receiving the laser energy output level, and a wavelength value of the laser light emitted from the delivery tip of the laser probe. The wavelength value of the laser light emitted from the delivery tip may remain constant regardless of the diameter of the optical fiber core. In such an embodiment, the laser management system (i.e., the control system) automatically adjusts (i.e., increases or decreases) the laser energy output level from the laser source according to the diameter of the optical fiber core, maintaining a constant wavelength of laser light emitted from the multiple laser probes to the target site, even when the diameter of the optical fiber core changes.

[0233] Thus, the system of various embodiments can compensate for wide variations in multiple laser probes simply by adjusting the power of the laser source to account for such variations. As a result, less precision is required in the manufacturing process, thereby relaxing manufacturing tolerances for the optical fiber and reducing overall costs. Furthermore, fine-tuning the laser power ensures that the laser light remains at a consistent wavelength, ensuring that the target site is treated as intended and maintaining patient safety.

[0234] Various embodiments provide a system for calibrating the output from a laser source to compensate for increased variations in the laser optical fiber. In such a system, the elements generally include a laser source that generates laser energy that is provided to one of a plurality of laser probes that can be coupled to the laser source. Each laser probe includes an optical fiber having an optical fiber core, the optical fiber adapted to direct laser light from the laser source through the fiber to a desired treatment site. The system further includes a laser management system that manages the laser source. The management system includes a control system that adjusts the laser energy output from the laser source to any given laser probe to maintain a constant level of laser light delivered to the target site despite variations in the optical fiber core of any given laser probe.

[0235] Thus, the system of various embodiments can compensate for wide variations in multiple laser probes simply by adjusting the power of the laser source to account for such variations. As a result, less precision is required in the manufacturing process, thereby relaxing manufacturing tolerances for the optical fiber and reducing overall costs. Furthermore, fine-tuning the laser power ensures that the laser light remains at a consistent wavelength, ensuring that the target site is treated as intended and maintaining patient safety.

[0236] The systems of various embodiments may be suitable for intraocular procedures where laser treatment of target tissue is desired. In particular, the laser sources, laser management systems, and laser probes of various embodiments are used to treat glaucoma and are useful when performing laser trabeculotomy. However, it should be noted that systems consistent with the present disclosure may be used in any laser treatment of a variety of conditions, including other eye conditions (i.e., diabetic eye diseases such as proliferative diabetic retinopathy and macular edema, age-related macular degeneration, retinal breaks, and cases of retinopathy of prematurity, as well as laser in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) and astigmatism), as well as other conditions in other general and other medical fields (outside of ophthalmology).

[0237] 36 is a diagram illustrating an excimer laser system including a laser unit system 5100 and a laser probe 5200 attached to the laser unit system 5100. The system 5100 includes a laser source 5102 and a laser management system 5108. The laser probe 5200 includes a fiber core 5204. As described in more detail herein, many of the components of the laser unit system 5100 can be housed in a housing, such as a movable platform, that is located at the location where the procedure will be performed (e.g., an operating room, treatment room, outpatient clinic), and the probe 5200 can be connected to the housing for use during treatment. When the probe 5200 is connected to the housing, the fiber core 5202 is adapted to connect to the laser source 5102 and direct laser light from the laser source 5102 through the fiber to the treatment site.

[0238] The laser source 5102 includes an excimer laser 5104 and a gas cartridge 5106 that provides the appropriate gas combination to the laser 5104. The excimer laser 5104 is a type of ultraviolet laser, which generally operates in the UV spectral region and generates nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cartridge 5106) is generally a gas mixture containing a noble gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate electrical stimulation and high pressure, quasi-molecules called excimers (or exciplexes, in the case of noble gas halides) are created, which can exist only in an excited state and generate laser light in the UV range.

[0239] Laser action in excimer molecules occurs because the excimer molecules have a bonded (associative) excited state but a repulsive (dissociative) ground state. Rare gases, such as xenon and krypton, are highly inert and do not normally form compounds. However, when in an excited state (induced by an electric discharge or a high-energy electron beam), rare gases can form temporarily bonded molecules with themselves (excimers) or with halogens, such as fluorine or chlorine (exciplexes). The excited compounds release excess energy through spontaneous or stimulated emission, resulting in highly repulsive ground-state molecules that very rapidly (on the order of picoseconds) dissociate back into two unbonded atoms. This creates a population inversion. The excimer laser 5104 in this system 5100 is a XeCl excimer laser emitting at a wavelength of 308 nm.

[0240] The laser management system 5108 manages the laser source 5102. In particular, as shown in FIG. 37 , the laser management system 5108 includes a controller 5110 (also referred to herein as a “control system 5110”). The controller 5110 allows an operator (i.e., a surgeon or other medical professional) to control the output of the laser signal (from the laser source 5102 to the fiber core 5202), which in turn allows the operator to control the delivery of laser energy from the fiber core 5202 of the probe 5200. However, before providing the operator with control over the laser output, the laser management system 5108 provides a calibration process in which the laser energy output from the laser source 5102 to the laser probe 5200 is calibrated so that the laser light delivered from the probe 5200 to the target site maintains a consistent level, even if there are variations in the optical fiber core 5202 of the probe 5200.

[0241] Figure 37 illustrates a laser unit system 5100 and the calibration of the laser output power to a laser probe 5200 used with the system 5100 to account for variations in the optical fiber core of the laser probe 5200. Figure 38 illustrates a process for calibrating the laser output power, which includes adjusting the laser energy output from the laser source to the laser probe to account for variations in the optical fiber core 5202 of the laser probe 5200.

[0242] As part of the initial setup, the controller 5110 receives data related to the laser probe coupled to the laser source 5102. In this case, data from the laser probe 200 is provided to the controller 5110. This data may be entered manually (via a user interface provided with the system 5100) or may be automatically read from a readable device or label on the probe 200 by an associated reader of the system 5100. The data may include physical characteristics of the probe 5200, including, but not limited to, the physical dimensions of the optical fiber core 5202, one or more measurements or physical properties of the optical fiber core 5202, and the physical dimensions and / or measurements or physical properties of other components of the probe 5200. In one embodiment, the data includes the diameter of the optical fiber core 5202.

[0243] The data is then analyzed by the controller 5110, and based on that analysis, an optimal level of laser energy to be output from the laser source 5102 is determined. This analysis is based on a correlation of laser probe data, such as the specific dimensions of the optical fiber core, with the calibration data. The calibration data is stored in a database, either a local database forming part of the laser unit system 5100 (i.e., calibration database 5112) or a remote database hosted by a remote server 5300 (i.e., calibration database 5302). For example, in some embodiments, the system 5100 can communicate and exchange data with the remote server 5300 over a network. The network can represent, for example, a private or non-private local area network (LAN), a personal area network (PAN), a storage area network (SAN), a backbone network, a global area network (GAN), a wide area network (WAN), or any such collection of computer networks, such as an intranet, an extranet, or the Internet (i.e., a global system of interconnected networks on which various applications or services run, including, for example, the World Wide Web).

[0244] The calibration data can generally include multiple value sets, each value set including a power level of laser energy from a laser source, a diameter of an optical fiber core of a laser probe receiving the power level of laser energy, and a wavelength value of laser light emitted from a delivery tip of the laser probe. The wavelength value of the laser light emitted from the delivery tip can remain constant regardless of the diameter of the optical fiber core. In such an embodiment, a laser management system (i.e., a control system) automatically adjusts (i.e., increases or decreases) the power level of laser energy from the laser source depending on the diameter of the optical fiber core to maintain a constant wavelength of laser light at the target site from the multiple laser probes, even when the diameter of the optical fiber core changes.

[0245] The controller 5110 may include software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions, instruction sets, and / or data in a memory device. As used in any embodiment herein, "circuitry" may include, alone or in any combination, hardwired circuitry, programmable circuitry such as a computer processor including one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by the programmable circuitry. For example, the controller 5104 may include a hardware processor coupled to a non-transitory computer-readable memory that includes instructions executable by the processor to cause the controller to perform various functions of the laser system 5100 described herein, including the calibration process. For example, the controller 5110 may include custom, proprietary, known, and / or after-developed statistical analysis code (or instruction set), hardware, and / or firmware that is generally well-defined and operable to receive two or more sets of data, identify correlation levels to at least a certain extent, and thereby associate the sets of data with each other based on the correlation levels.

[0246] 4 is similar to and can be used (in whole or in part) as the laser unit system 5100 and / or laser source 5102. In various embodiments, the laser source 5102 (including the excimer laser 5104 and gas cartridge 5106) and the laser management system 5108, including the controller 5110, can be contained in the housing 402. An operator can manually input laser probe data via an interactive user interface, thereby providing such data to the laser management system 5108 and the controller 5110. However, in various embodiments, the data can be automatically read from a readable (e.g., optically and / or electronically readable) device or code and / or label on the probe 5200 via an associated reader in the system 5100.

[0247] Probes such as those shown in FIGS. 4-6, 21, 24, 29, and / or 32 may be used with the excimer laser system 5100. For example, FIG. 39 illustrates one embodiment of the laser probe 500 attached to the laser unit system 5100. As previously described, upon attaching the laser probe 500 to the system 5100 (i.e., mating the connection assembly 504 of the probe 500 with the connection port 406 of the system 400), the laser management system 5108 (including the controller 5110) performs a calibration process on the probe 500 prior to use. In particular, data related to characteristics of the probe 500, such as the diameter of the optical fiber core, is provided to the laser management system 5108. The data is then analyzed by the controller 5110, and based on that analysis, an optimal level of laser energy output from the laser source is determined. The optimal level of laser energy output from the laser source may be determined based on a correlation between laser probe data, such as the specific dimensions of the optical fiber core, and the calibration data. The controller 5110 automatically adjusts (i.e., increases or decreases) the laser energy output level from the laser source according to the diameter of the optical fiber core, maintaining a constant wavelength of laser light emitted from the multiple laser probes to the target site even when the diameter of the optical fiber core changes.

[0248] Thus, the systems of various embodiments can compensate for wide variations in multiple laser probes by simply adjusting the power of the laser source. As a result, less precision is required in the manufacturing process, allowing for relaxed manufacturing tolerances for optical fibers, thereby reducing overall costs. Furthermore, fine adjustment of the laser power also maintains a consistent wavelength of the laser radiation, ensuring that the target site is treated as intended and maintaining patient safety.

[0249] [Combined treatment with ELT] In glaucoma, a fluid known as aqueous humor builds up in the anterior chamber of the eye. Aqueous humor normally drains from the eye at a site known as the trabecular meshwork, typically through Schlemm's canal within the meshwork. However, when a person develops glaucoma, the buildup of aqueous humor causes elevated intraocular pressure (IOP). Elevated IOP gradually damages the optic nerve, causing irreversible vision loss.

[0250] Traditional methods for treating glaucoma manage symptoms by lowering IOP or suppressing aqueous humor production. Traditional glaucoma treatments include drug therapy, laser therapy, surgical therapy, and combinations thereof. Drug therapy does not provide a permanent solution; instead, it manages symptoms by suppressing aqueous humor production or increasing aqueous humor drainage to lower IOP. Laser therapy can also be used to lower IOP by increasing aqueous humor outflow or suppressing aqueous humor production. However, laser therapy and drug therapy are often ineffective in treating advanced glaucoma. Therefore, glaucoma patients are also treated with surgical procedures, such as inserting an implant into the eye to increase drainage. However, these procedures carry risks, such as implant loss.

[0251] Various embodiments provide a method for concurrently treating glaucoma with excimer laser trabeculotomy (ELT). The method involves performing ELT on a patient with glaucoma who has failed previous treatments. Because glaucoma is a progressive disease, previous treatments may become ineffective as the condition worsens. As a result, patients often endure multiple failed treatments. Various embodiments of the method provide for the treatment of glaucoma with ELT, even when previous treatments have failed. During an ELT procedure, a laser probe is placed near Schlemm's canal to create perforations in the trabecular meshwork and / or Schlemm's canal, immediately improving aqueous humor drainage. These perforations can also increase aqueous humor outflow and reduce intraocular pressure.

[0252] In various instances, the unsuccessful treatment is a conventional method of treating glaucoma, such as prescription or pharmaceutical treatment, laser treatment, surgical treatment, or a combination thereof. Typically, the prescription or pharmaceutical treatment is a therapeutic eye drop, such as an alpha agonist, a beta blocker, a carbonic anhydrase inhibitor, a cholinergic agonist, a prostaglandin / prostamide analog, or a combination thereof. Examples of laser treatments include trabeculoplasty, iridotomy, iridectomy, and combinations thereof. Examples of trabeculoplasty include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Due to the relatively high complication rate and unpredictability of procedures such as trabeculectomy, surgery is usually a last resort treatment after medical (drug) therapy and laser therapy. Examples of surgical treatments include insertion of a shunt or implant, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscoelastic canalectomy, or a combination thereof.

[0253] One example relates to providing glaucoma treatment to a subject who has received a previous glaucoma treatment that has failed or lost its effectiveness. For example, a drug treatment may have previously been effective in treating the subject's glaucoma before the glaucoma progressed to a state where the drug treatment was no longer effective. The subject may have received a laser treatment, such as selective laser trabeculoplasty (SLT), to treat the glaucoma. SLT may have been effective in treating the glaucoma until the condition worsened. Various methods provide ELT, which allows drainage of aqueous humor accumulated in the anterior chamber, as a treatment after the previous treatment has failed or lost its effectiveness. This includes repeating ELT on the same or a different part (quadrant) of the eye.

[0254] In one example, a subject with advanced glaucoma was administered prescription medications until they were ineffective, SLT as a laser therapy until it was ineffective, and then a stent was implanted, but the stent subsequently dislodged. Because the subject had advanced glaucoma, treatments such as medications and existing laser therapies may not be effective in treating this condition. Furthermore, as a result of unsuccessful surgical placement of the stent, the stent is not draining aqueous humor that has accumulated in the anterior chamber of the eye. By providing ELT treatment using various methods, perforations are formed in the trabecular meshwork and / or Schlemm's canal, allowing aqueous humor to drain. Thus, various embodiments are effective in draining accumulated aqueous humor even when previous treatments have failed.

[0255] In some embodiments, one or more previous treatments are still effective.In such cases, ELT is administered to provide a combined treatment for glaucoma.By administering ELT in addition to other effective treatments, the drainage of aqueous humor from the anterior chamber of the eye is increased.For example, for glaucoma patients who have not been successful in one treatment, such as drug treatment, ELT and SLT may be administered as a combined treatment.In some cases, such combined treatments may be administered to patients during the same surgical consultation.

[0256] During an ELT procedure, a physician guides the delivery tip of a fiber probe through a corneal incision in the eye and into the trabecular meshwork. In some instances, various embodiments further include anesthetizing the subject before creating the incision and inserting the probe. Typically, the incision is about 1 / 8 inch long or less. In some instances, one or more sutures are used to close the incision after the ELT treatment. The physician guides the delivery tip to a position near Schlemm's canal and creates permanent perforations in the trabecular meshwork and / or Schlemm's canal. The perforations created in Schlemm's canal and / or trabecular meshwork by the excimer laser immediately improve fluid drainage in the anterior chamber of the eye. These perforations can also increase aqueous humor outflow and reduce intraocular pressure. In some instances, a physician uses a goniolens, endoscope, or other illumination source to assist in the placement of the fiber probe delivery tip. Typically, the physician will use a goniolens to observe slight backflow bleeding intraoperatively as a criterion, allowing for effective placement of the fiber in the trabecular meshwork to create a flow path into Schlemm's canal. An additional criterion is mild backflow bleeding observable intraoperatively, allowing for effective placement of the fiber in the trabecular meshwork to open Schlemm's canal.

[0257] Once the delivery tip reaches a position near Schlemm's canal, a series of shots of laser energy are delivered to the trabecular meshwork. In one example, a 308 nm xenon chloride ultraviolet excimer laser is used in various embodiments. A 308 nm xenon chloride ultraviolet excimer laser minimizes thermal damage compared to visible or infrared lasers. In some examples, the excimer laser is a sealed xenon chloride (XeCl) excimer laser, such as the EXTRA LASER manufactured by MLase AG. Unlike argon laser trabeculoplasty and selective laser trabeculoplasty, ELT precisely ablates tissue without causing thermal damage or leaving scars in the surrounding tissue. Because ELT is a non-thermal procedure, there is no postoperative development or activation of tissue reactions in the trabecular meshwork. Because ELT does not generate heat, postoperative activation of tissue reactions is virtually eliminated, resulting in long-term, consistent intraocular pressure reduction.

[0258] Furthermore, to prevent corneal absorption of the laser light, an optical fiber is used to deliver the energy. The delivery tip of the fiber probe includes an optical fiber coated with a metal such as stainless steel. In some examples, the delivery tip is beveled (e.g., at 0°, 15°, 30°, and 45° relative to the tip). The fiber probe includes an optical fiber suitable for UV light, which is embedded in a handheld laser applicator. For example, the FIDO LASER APPLICATOR manufactured by MLase AG can be used as the fiber probe.

[0259] A total of approximately 10 ELT treatment sites, i.e., perforations (each approximately 200 μm in diameter), are laser-created in the trabecular meshwork and / or Schlemm's canal to facilitate easier drainage of aqueous humor, leading to lower IOP. In one example, approximately 10 shots are delivered from the excimer laser source to each eye. In some examples, more than 10 shots are delivered to each eye. In comparison, the individual diameters of the stents and implants are smaller, between approximately 80 μm and approximately 120 μm.

[0260] In some embodiments, the patient is administered an anesthetic prior to surgery. In some instances, the anesthesia is local anesthesia. In some instances, the anesthesia includes topical anesthesia. In some instances, the patient is given general anesthesia. The eye is first anesthetized with eye drops, followed by an anesthetic injection around the eye. The anesthetic injection itself may be mildly uncomfortable, and a slight pressure may be felt as the anesthetic is injected. This injection anesthetizes the eye, preventing pain during surgery as well as excessive eye movement.

[0261] Various embodiments provide for the treatment of glaucoma with ELT after previous treatments have failed or become ineffective. Previous treatments may include drug treatments, laser treatments, surgical treatments, or a combination thereof. For example, a patient may have previously been prescribed therapeutic eye drops and undergone selective laser trabeculoplasty (SLT) procedures, but their condition may have progressed to a stage where these treatments are no longer effective. Various embodiments provide methods for treating glaucoma patients who have failed previous treatments by administering ELT therapy.

[0262] In various embodiments, the failed treatment is a prescription or pharmaceutical treatment, a laser treatment, a surgical treatment, or a combination thereof. Conventional treatments for glaucoma include therapeutic eye drops, laser treatment, and surgical treatment. Surgery is typically a last resort treatment after medical (drug) treatment and laser treatment due to the relatively high complication rate and unpredictability of treatments such as trabeculectomy.

[0263] Typically, the prescription drug or pharmaceutical treatment is a therapeutic eye drop, such as an alpha agonist, a beta blocker, a carbonic anhydrase inhibitor, a cholinergic agonist, a prostaglandin / prostamide analog, or a combination thereof. Examples of laser treatments include trabeculoplasty, iridotomy, iridectomy, and combinations thereof. Examples of trabeculoplasty include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Examples of surgical treatments include shunt or implant insertion, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscoelastic tube dissection, or a combination thereof.

[0264] Medications are the most common initial treatment for glaucoma, and drug options include therapeutic eye drops, tablets, or both. All medications available for the treatment of glaucoma must be taken regularly. Examples of therapeutic eye drops include alpha agonists, beta blockers, carbonic anhydrase inhibitors, cholinergic agonists, and prostaglandin / prostamide analogs.

[0265] Alpha agonists, such as apraclonidine and brimonidine, are used to reduce fluid production in the eye and improve fluid flow from the eye. Eye drops are typically used two or three times daily. Apraclonidine is used short-term after laser treatment or to delay laser treatment. Brimonidine is approved for the long-term treatment of glaucoma but is contraindicated in children under the age of 2. Side effects include dry mouth, fatigue, and general weakness. Patients may experience severe allergic reactions to eye drops, which can worsen eye redness, pain, and stickiness. Alpha agonists include brimonidine preparations (ALPHAGAN, manufactured by Allergan, Inc.).

[0266] Beta-blockers include betaxolol, carteolol, levobunolol, and timolol, which are used to reduce fluid production in the eyes. Eye drops are used once or twice daily and are generally not prescribed for people prone to chest or breathing problems. Side effects include bradycardia, dizziness, asthma, fatigue, depression, decreased libido, and impotence. Beta-adrenergic blocking eye drops include timolol (TIMOPTIC, manufactured by Bausch and Lomb; BETIMOL, manufactured by Akorn, Inc.), levobunolol (BETAGAN, manufactured by Allergan, Inc.), betaxolol (BETOPTIC, manufactured by Alcon Laboratories, Inc.), carteolol (OCUPRESS, manufactured by Bausch and Lomb Pharmaceuticals, Inc.), and metipranolol (OPTIPRANOLOL, manufactured by Bausch and Lomb Pharmaceuticals, Inc.).

[0267] Carbonic anhydrase inhibitors, such as brinzolamide and dorzolamide, reduce fluid production in the eye. These eye drops are used alone, two or three times daily, or twice daily when combined with another eye drop. Side effects include bloodshot eyes, crusting of eyelashes, fatigue, and a bitter taste in the mouth. Carbonic anhydrase inhibitors include the oral medications acetazolamide (DIAMOX SEQUELS, manufactured by Teva Pharmaceuticals USA, INC.) and methazolamide (NEPTAZANE, manufactured by Perrigo Company plc, Dublin, Ireland), as well as the eye drops brinzolamide (AZOPT, manufactured by Alcon Laboratories, Inc., a Novartis Company, and Novartis Pharmaceuticals Corporation, USA) and dorzolamide (TRUSOPT, manufactured by Santen Pharmaceutical Co., Ltd.).

[0268] Cholinergic eye drops, such as pilocarpine, are used to improve fluid flow from the eye. Cholinergic eye drops improve normal fluid flow. Eye drops are used three or four times daily. Miotic eye drops include pilocarpine hydrochloride solution, manufactured by Akorn, Inc.

[0269] Prostaglandin / prostamide analogs include bimatoprost, latanoprost, tafluprost, and travoprost. These eye drops are used to improve fluid flow from the eye through an unconventional route. These eye drops are used once daily. Side effects include conjunctivitis, which usually improves over time, darkening of the iris, elongation and darkening of the eyelashes, and darkening of the skin around the orbit of the eye. Examples of prostanoid FP receptor agonists (sensitive to prostaglandin F) include latanoprost (XALATAN, manufactured by Pfize Inc.), bimatoprost (LUMIGAN, manufactured by Allergan, Inc.), travoprost (TRAVATAN Z, manufactured by Novartis Pharmaceuticals Corporation), unoprostone (RESCULA, manufactured by Sucampo Pharma Americas, LLC), and tafluprost (ZIOPTAN, manufactured by Akorn, Incorporated).

[0270] Several laser procedures are used to treat glaucoma. Different types of glaucoma are treated with different laser procedures. In open-angle glaucoma, laser procedures are used to increase aqueous outflow from the eye and lower intraocular pressure (IOP) (laser trabeculoplasty) or to suppress aqueous production (cyclophotocoagulation). In narrow-angle glaucoma, laser iridotomy is used to create a small hole in the iris to improve fluid drainage, or iridoplasty is performed to shrink the iris and open up the drainage angle.

[0271] Argon laser trabeculoplasty (ALT) is used to treat chronic open-angle glaucoma. ALT was originally performed using an argon laser, but currently, the laser used is a frequency-doubled YAG laser, which performs a similar function. It typically targets the trabecular meshwork, treating half of the eye in one treatment. If necessary, the other half can be treated later. Treatment requires topical anesthesia. While the treatment may be used instead of eye drops, it is usually used as an adjunct to ongoing eye drop treatment. After several years, the effectiveness of ALT may decrease, and a different type of laser therapy or surgery may be required. Several follow-up visits are required after treatment to monitor the patient's IOP and inflammation. Most patients typically require long-term anti-glaucoma eye drops to maintain desired IOP levels.

[0272] Selective laser trabeculoplasty (SLT) is used to treat chronic open-angle glaucoma. SLT is similar to ALT but uses a gentler, larger laser beam. In SLT, the laser is directed at the trabecular meshwork, but at a lower power level than ALT treatments. The best SLT results are achieved when the entire 360° of the trabecular meshwork is treated at once. Unlike ALT, SLT can be repeated if the treatment's effectiveness wears off. Several follow-up visits are required after treatment to monitor the patient's IOP and inflammation. Most patients typically require long-term anti-glaucoma eye drops to maintain desired IOP levels.

[0273] Transscleral photocoagulation, cyclodiode laser, or diode laser cycloablation are used to treat chronic open-angle glaucoma. The laser is used to target the ciliary body, which produces aqueous humor. Treatment often requires the injection of a general or local anesthetic. Transscleral photocoagulation can be repeated if the IOP is not considered low enough or if the effectiveness of the procedure diminishes over time. Cyclodiode is also recommended for several other forms of glaucoma in which the IOP is so high that traditional surgery is contraindicated or impossible. Patients who undergo cyclodiode treatment often require strong pain medication after treatment. Several follow-up visits are required after treatment to monitor the patient's IOP and inflammation. Most patients typically require long-term anti-glaucoma eye drops to control IOP to the desired level.

[0274] Laser iridotomy is used to treat angle-closure and narrow-angle glaucoma. Laser iridotomy uses a YAG laser to create a small hole to alleviate the narrow or closed angle. As aqueous humor passes through the hole, the iris retracts away from the trabecular meshwork, allowing the fluid to drain freely through the meshwork. Anesthetic eye drops are typically administered as an anesthetic. However, in some eyes, the iris does not retract as desired, necessitating other treatments. Even if the iris is properly positioned, medication or surgery may still be required to manage IOP. Post-laser eye drops (usually in the form of steroids) may be required, as may anti-glaucoma eye drops, either temporarily or indefinitely.

[0275] Peripheral iridoplasty is used to treat angle-closure and narrow-angle glaucoma. Peripheral iridoplasty may be used in eyes that have had laser iridotomy and the iris has not retracted. An argon laser or a frequency-doubled YAG laser is applied to the outer edge of the iris, causing it to contract and move away from the trabecular meshwork, which is its drainage route, widening the drainage angle. Anesthesia other than anesthetic eye drops may be required. Post-laser eye drops (usually in the form of a steroid) may be required, and anti-glaucoma eye drops may be needed temporarily or indefinitely.

[0276] Several surgical treatments are available for the treatment of glaucoma, but surgery is often considered a last resort, reserved for patients with late-stage glaucoma, after medications and laser treatments have become ineffective in treating the condition.

[0277] Aqueous shunts are used to lower intraocular pressure (IOP) in glaucoma by draining fluid from inside the eye into a small bleb or bleb behind the eyelid. Aqueous shunts also have various other names, such as tube implants, glaucoma tube shunts, glaucoma drainage devices, and glaucoma drainage implants. Two commonly used types of shunts include the Ahmed Glaucoma Valve (manufactured by New World Medical, Rancho Cucamonga, California, USA) and the Barbert Glaucoma Implant (manufactured by Advanced Medical Optics, Inc., Santa Ana, California, USA). These shunts consist of a small silicone tube (less than 1 mm in diameter) attached to a plate. This tube receives aqueous humor from inside the eye and drains it into a plate in the white part of the eye (the sclera). The plate is located under the epidermis (conjunctiva) of the eye, behind the eyelid.

[0278] Trabeculectomy is a surgical procedure used to treat glaucoma and is sometimes called filtration surgery. During trabeculectomy, a physician removes a portion of tissue in the drainage angle of the eye to create an opening. This opening is partially covered by a flap of tissue from the sclera (the white part of the eye) and conjunctiva (the clear, thin outer covering on the sclera). The newly formed opening allows fluid to drain from the eye, bypassing the blocked drainage channel in the trabecular meshwork. Blebs form when fluid flows through the new drainage opening, causing the tissue overlying the opening to bulge, forming a small blister or gas bubble.

[0279] Trabeculotomy is a surgical procedure very similar to trabeculectomy. The doctor removes some of the tissue in the drainage angle of the eye to create an opening. The newly formed opening allows fluid to drain from the eye. Trabeculotomy is a surgery that is only performed in children.

[0280] During goniotomy, the doctor uses a goniolens to view the tissue at the front of the eye, known as the anterior chamber. The doctor then creates an opening in the trabecular meshwork (a collection of tiny tubes located in the drainage angle where fluid leaves the eye). This newly formed opening allows fluid to drain from the eye. Goniotomy is a procedure reserved for children.

[0281] Deep sclerectomy is a non-penetrating surgical procedure used to treat open-angle glaucoma. The deep sclerectomy procedure involves removing the inner wall of Schlemm's canal and the juxta-canalicular trabecular meshwork, the tissues that account for most of the outflow resistance in open-angle glaucoma. Aqueous outflow is improved, and the trabecular meshwork-Descemet's membrane (TDM) is left intact to control aqueous outflow through the filtration site.

[0282] Viscocanalostomy involves incising a tissue flap in the conjunctiva and sclera to expose a portion of the drainage canal (Schlemm's canal). The procedure involves creating a superficial scleral flap and a deep scleral flap, resecting the deep scleral flap to create a scleral reservoir, and removing the upper portion of Schlemm's canal. A high-viscosity elastic gel is injected into Schlemm's canal, opening and dilating it to increase fluid flow from the anterior chamber. For example, the high-viscosity viscoelastic material may contain sodium hyaluronate. The tissue flap is then closed. For example, the superficial scleral flap can be sutured to seal and contain the viscoelastic material until healing occurs.

[0283] Previously attempted treatments have become ineffective in treating glaucoma in some patients. Embodiments herein utilize an excimer laser to permanently perforate Schlemm's canal and / or trabecular meshwork, creating an internal outflow channel. Such ablation using an excimer laser causes little to no thermal damage and minimizes inflammation and scar tissue formation. In contrast, other lasers, such as ruby ​​and argon lasers, are unable to achieve permanent perforation of the trabecular meshwork due to inflammatory and healing responses. Therefore, various embodiments utilize ELT to restore fluid outflow from the eye without inducing a healing response in the target tissue. Because the treatment methods of various embodiments eliminate inflammation and scar tissue formation, they require a shorter recovery time than traditional surgical treatments, such as implant placement.

[0284] In embodiments, a patient is exposed to multiple shots from an excimer laser to create perforations in the trabecular meshwork and / or Schlemm's canal. ELT gasifies the trabecular meshwork tissue through photoablation. Creating permanent perforations in Schlemm's canal and / or trabecular meshwork allows for the rapid drainage of fluid that has accumulated in the eye. Furthermore, the perforations increase aqueous humor outflow and fluid drainage, thereby preventing vision loss resulting from optic nerve damage due to buildup.

[0285] FIG. 40 shows a flowchart of one embodiment 4100. Various embodiments relate to treating a patient with glaucoma using ELT. In various embodiments, the energy shot delivered from the excimer laser is located near Schlemm's canal. Various embodiments are performed after a patient with glaucoma has undergone previous, ineffective treatment 4110. Treatments other than ELT include traditional drug treatments, laser treatments, and surgical treatments. For example, drug treatments include tablets, eye drops, or both. Typically, the prescribed drug or drug treatment is a therapeutic eye drop, such as an alpha agonist, beta blocker, carbonic anhydrase inhibitor, cholinergic agonist, prostaglandin / prostamide analog, or a combination thereof. Examples of laser treatments include trabeculoplasty, iridotomy, iridectomy, and combinations thereof. Examples of trabeculoplasty include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Examples of surgical treatments include insertion of a shunt or implant, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscoelastic canalectomy, or a combination thereof.

[0286] In various embodiments, ELT is performed even if other treatments have been previously performed and have been ineffective. For example, if a shunt has been placed in a subject's eye but has subsequently become dislodged, ELT treatment can still be performed. ELT treatment creates permanent perforations in Schlemm's canal and / or trabecular meshwork, allowing fluid that has accumulated within the eye to drain.

[0287] The method of various embodiments includes a pre-operative analysis 4120, which includes diagnosing the eye disease, determining a course of treatment based on previously unsuccessful treatments, examining and / or visualizing the anterior chamber of the eye to aid in laser probe placement, and analyzing the number of laser shots required for treatment. In various embodiments, excimer laser trabeculotomy (ELT) is used to treat glaucoma.

[0288] The method includes anesthetizing the patient 4130. Local anesthesia is commonly used, usually administered by instilling a local anesthetic, such as tetracaine or lidocaine, into the eye. Lidocaine and / or long-acting bupivacaine anesthetics may be injected into the area surrounding the eye cone (peribulbar block) or behind the eye cone (retrobulbar block), thereby more completely immobilizing the extraocular muscles and minimizing pain. Optionally, a facial nerve block may be performed using lidocaine and bupivacaine to inhibit eyelid closure. In some cases, general anesthesia is administered with cardiovascular monitoring, such as in children, patients with traumatic eye injuries, and nervous or uncooperative patients and animals. Appropriate sterile precautions must be taken to prepare the surgical site, including the use of antiseptics such as povidone-iodine and the use of sterile drapes, gowns, and gloves. In some cases, an eyelid speculum is inserted to maintain eyelid open.

[0289] A physician makes a small incision in the patient's eye at 4140. Before performing the ELT procedure, a small incision is made in the cornea of ​​the eye to allow for the introduction of a laser probe. Typically, the incision is approximately 1 / 8 inch or smaller. During the ELT procedure, the physician guides the delivery tip of the fiber probe through the corneal incision in the eye and near the trabecular meshwork. The delivery tip is then guided by the physician to a position near Schlemm's canal. A goniolens, endoscope, and / or illumination source may be used by the physician to assist in the placement of the delivery tip. By positioning the laser probe near or intersecting Schlemm's canal, the laser illuminates a larger surface area than if the laser were positioned parallel or perpendicular to Schlemm's canal, resulting in more perforations being created with fewer laser shots. Therefore, positioning the delivery tip near Schlemm's canal provides optimal photoablation and perforation creation in the trabecular meshwork and / or Schlemm's canal for fluid evacuation. The orientation and placement of the delivery tip are critical when creating perforations in tissue. This is because optimal drainage is achieved by achieving placement of the perforations within the trabecular meshwork relative to Schlemm's canal.

[0290] Once the delivery tip reaches a position proximate to Schlemm's canal, the physician administers ELT treatment to the patient by applying a series of shots of laser energy at 4150 to the trabecular meshwork and / or Schlemm's canal. The physician applies pulsed photoablative energy to create ELT treatment sites, i.e., perforations, in the trabecular meshwork and / or Schlemm's canal. In some instances, the physician creates 10 ELT treatment sites in one eye of the patient. In some instances, the physician creates more than 10 ELT treatment sites. The creation of each opening is confirmed by a small amount of blood reflux from Schlemm's canal. The fiber probe is then removed from the eye. Notably, IOP decreases immediately after administering the ELT treatment.

[0291] After administering the ELT treatment, the physician closes the incision at 4160. Typically, the physician uses sutures to close the incision. Some physicians suture the incision, while others refrain from suturing in case there is persistent leakage.

[0292] The method of various embodiments includes analyzing the post-operative results at 4170 and reporting the results to the surgical patient and / or scheduling a post-operative follow-up appointment with the patient at 4180. For example, the physician's analysis may include checking each opening by observing for a small amount of blood reflux from Schlemm's canal. By observing blood reflux and aqueous humor drainage, the physician can immediately confirm the effectiveness of the laser treatment. The physician can then report the results to the patient, prescribe post-operative medications such as topical antibiotic and steroid eye drops, and schedule a post-operative follow-up appointment with the patient. For example, topical antibiotic and steroid eye drops are used by the patient for one to two weeks after surgery.

[0293] Systems such as those shown in Figures 3-6, 21-33, and / or 36-39 may be used in various embodiments. Such systems may include the components shown in Figure 41. Figure 41 illustrates a system 6300 for treating glaucoma in accordance with various embodiments. The treatment system 6300 includes an interactive user interface 6310 (an example of the user interface 410), a fiber probe 6320 (an example of the fiber probes 102, 104, 500, 4200, and 5200), a controller 6330, and an excimer laser trabeculotomy (ELT) system 6340. The excimer laser system 6340 includes an excimer laser 6350 and a gas cartridge 6360. The excimer laser system 6340, the interactive user interface 6310, and the fiber probe 6320 are communicatively coupled to the controller 6330. Additionally, the excimer laser system 6340 may be contained in a housing that includes an interactive user interface, and a fiber probe may be connected to the housing for use during ELT treatment.

[0294] The controller 6330 includes a processor, which typically includes a single-core or multi-core chip providing a central processing unit (CPU), such as a chip manufactured by Intel or AMD. The controller 6330 allows an operator (i.e., a doctor, surgeon, or other medical professional) to control the treatment system 6300, including programming the fiber probe, outputting laser light signals, and the like. It also controls the delivery of laser energy from the laser source 6350 to the fiber probe 6320, which performs the laser delivery (irradiation).

[0295] The controller 6330 may include software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions or instruction sets, and / or data in a memory device. As used in any embodiment herein, "circuitry" may include, for example, hardwired circuitry, programmable circuitry such as a computer processor including one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by a programmable circuit, alone or in any combination. For example, the controller 6330 can include a hardware processor coupled to a non-transitory computer-readable memory that stores instructions executable by the processor, the instructions causing the controller to perform various functions of the treatment system 6300 described herein, including controlling laser delivery and programming the number of laser shots that can be delivered (irradiated) by the fiber probe 6320 using the interactive user interface 6310.

[0296] The laser system 6340 includes an excimer laser 6350 and a gas cartridge 6360 that provides the appropriate gas combination to the laser 6350. The excimer laser 6350 is a type of ultraviolet laser, which generally operates in the UV spectral region and generates nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cartridge 6360) is generally a gas mixture containing a noble gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate electrical stimulation and high pressure, quasi-molecules called excimers (or exciplexes, in the case of noble gas halides) are created, which can only exist in an excited state and generate laser light in the UV range.

[0297] Laser action in excimer molecules occurs because the excimer molecules have a bonded (associative) excited state but a repulsive (dissociative) ground state. Rare gases, such as xenon and krypton, are highly inert and do not normally form compounds. However, when in an excited state (induced by an electric discharge or a high-energy electron beam), rare gases can form temporarily bonded molecules with themselves (excimers) or with halogens, such as fluorine or chlorine, (exciplexes). The excited compounds release excess energy through spontaneous or stimulated emission, becoming highly repulsive ground-state molecules that very rapidly (on the order of picoseconds) dissociate back into two unbonded atoms. This creates a population inversion. The excimer laser 6350 in this system 6300 is a XeCl excimer laser emitting at a wavelength of 308 nm.

[0298] [Methods of transverse placement in ELT] Glaucoma is a leading cause of irreversible blindness. Normally, fluid flows freely through the anterior chamber of the eye and is expelled through a drainage system that includes the trabecular meshwork and Schlemm's canal. When a person has glaucoma, blockage of the trabecular meshwork or Schlemm's canal prevents fluid from draining, causing increased intraocular pressure. If left untreated, the increased intraocular pressure can damage the optic nerve, gradually reducing vision and ultimately leading to blindness.

[0299] Traditional methods for treating glaucoma include drug therapy, laser therapy, surgical therapy, or a combination of these to reduce intraocular pressure. Drug therapy, such as therapeutic eye drops, and laser therapy, such as selective laser trabeculoplasty (SLT), are often ineffective in treating advanced glaucoma. Invasive surgical treatments, such as the placement of implants or drainage stents, are used to treat advanced glaucoma. However, invasive surgical treatments have drawbacks, requiring careful attention to prevent implant dislodgement. For example, if a stent is not properly placed on the first attempt, subsequent stent placement may be difficult.

[0300] Various embodiments provide for the treatment of glaucoma using excimer laser trabeculotomy (ELT). During an ELT procedure, a laser probe is placed near Schlemm's canal, and a perforation is created in the trabecular meshwork and / or Schlemm's canal, forming a straight line across the canal. Creating a permanent perforation in the Schlemm's canal and / or trabecular meshwork allows for immediate drainage of fluid that has accumulated in the anterior chamber of the eye. Positioning the laser probe near Schlemm's canal provides a larger surface area for laser photoablation, resulting in optimal results. By irradiating a location near Schlemm's canal with the laser, a larger surface area is photoablated with each laser shot, resulting in larger perforations with fewer laser shots.

[0301] In open-angle glaucoma (OAG), obstruction of fluid outflow in the trabecular meshwork and the inner wall of Schlemm's canal is a primary cause of elevated intraocular pressure (IOP). Various embodiments use an excimer laser to create perforations in the trabecular meshwork and / or Schlemm's canal, creating internal outflow channels that increase the drainage of fluid known as aqueous humor from the anterior chamber of the eye. These perforations increase the flow of aqueous humor, thereby reducing intraocular pressure.

[0302] The method of various embodiments uses ELT to restore fluid outflow from the anterior chamber of the eye without inducing a healing response in the target tissue. ELT gasifies trabecular tissue through photoablation. Ablation using an excimer laser causes little thermal damage, minimizing inflammation and scar tissue formation. Unlike argon laser trabeculoplasty and selective laser trabeculoplasty, ELT precisely ablates tissue without causing burns or leaving scars in the surrounding tissue. Furthermore, other lasers, such as ruby ​​and argon lasers, are unable to achieve permanent perforation of the trabecular meshwork due to the inflammatory and healing responses. Because the method of various embodiments does not result in inflammation or scar tissue formation, it requires a shorter recovery time than traditional laser treatments or surgical treatments, such as implant placement.

[0303] In an ELT procedure, a physician guides the delivery tip of a fiber probe through a corneal incision in the eye and into the vicinity of the trabecular meshwork. In some embodiments, the methods of various embodiments include anesthetizing the subject before forming the incision and inserting the probe. Typically, the incision is about 1 / 8 inch long or less. The delivery tip is guided by the physician into a position near Schlemm's canal. In various embodiments, the physician uses a light source, such as a goniolens, endoscope, or other illumination source, to assist in the placement of the delivery tip. Additionally, the light source helps the physician confirm the effectiveness of the laser treatment by visualizing the drainage of aqueous humor and the backflow of blood during treatment.

[0304] Once the delivery tip reaches a position near Schlemm's canal, the physician delivers a series of shots of laser energy to the trabecular meshwork, which may form multiple perforations in a straight or curved line across Schlemm's canal (e.g., multiple perforations may be formed at different heights in Schlemm's canal to ensure perforations are formed in portions of the trabecular meshwork adjacent to Schlemm's canal). In this manner, positioning the delivery tip at successive positions across Schlemm's canal provides optimal photoablation and perforation of the trabecular meshwork and / or Schlemm's canal. Thus, forming multiple perforations increases the likelihood of immediate drainage of aqueous humor from the anterior chamber of the eye, leading to successful treatment and cure of glaucoma.

[0305] ELT treatment uses an excimer laser to create a long-term opening that directly connects the anterior chamber of the eye to Schlemm's canal. Various embodiments use a 308 nm xenon chloride ultraviolet excimer laser. This laser minimizes thermal damage compared to visible or infrared lasers. In various embodiments, the excimer laser is a sealed xenon chloride (XeCl) excimer laser, such as the EXTRA LASER manufactured by MLase AG. Furthermore, to prevent corneal absorption of the laser light, an optical fiber is used to deliver energy from the excimer laser. The delivery tip of the fiber probe includes an optical fiber coated with a metal such as stainless steel. In some examples, the delivery tip is beveled (e.g., at 0°, 15°, 30°, and 45° relative to the tip). The fiber probe includes an optical fiber suitable for UV light, which is embedded in a handheld laser applicator. For example, the FIDO LASER APPLICATOR manufactured by MLase AG can be used as the fiber probe.

[0306] A total of approximately 10 ELT perforations (each approximately 200 μm in diameter) are laser-created in the trabecular meshwork and / or Schlemm's canal to facilitate easier drainage of aqueous humor to lower IOP. In comparison, the individual diameters of stents and implants are smaller, ranging from approximately 80 μm to approximately 120 μm. In some embodiments, approximately 10 shots from the excimer laser source are delivered to each eye. These energy shots may be delivered to one quadrant of the eye, the inferonasal quadrant, but may also be delivered to other quadrants. In some embodiments, more than approximately 10 shots may be delivered to each eye, and these shots may be delivered to the inferonasal quadrant and / or multiple quadrants of the eye. Because ELT is a non-thermal procedure, no postoperative tissue reaction or activation occurs in the trabecular meshwork. Because ELT does not generate heat, postoperative activation of the tissue reaction is largely suppressed, resulting in stable, long-term intraocular pressure reduction. Furthermore, unlike traditional glaucoma treatments that involve the placement of shunts or stents, the stability of Schlemm's canal with ELT treatment is not altered.

[0307] Glaucoma patients suffer from elevated intraocular pressure due to obstruction of the outflow of fluid from the eye. Various embodiments use an excimer laser to create perforations in the Schlemm's canal and / or trabecular meshwork of the eye. ELT treats open-angle glaucoma at the source by increasing the permeability of the trabecular meshwork. In ELT, the laser directly connects the anterior chamber of the eye to Schlemm's canal using a fiber probe that makes physical contact with the trabecular meshwork.

[0308] In various embodiments, the method includes inserting a probe into the eye of a subject having glaucoma, adjusting the position of the probe at successive positions while the probe is in proximity to the trabecular meshwork and / or Schlemm's canal, and applying multiple shots from an excimer laser source to form a series of perforations across Schlemm's canal in the eye, thereby treating glaucoma by forming multiple perforations in Schlemm's canal and / or trabecular meshwork. These perforations allow for immediate drainage of fluid from the anterior chamber of the eye. These perforations increase the flow of aqueous humor in the eye and reduce intraocular pressure.

[0309] 42 is a flowchart illustrating one embodiment 7100 of the method of various embodiments. Various embodiments relate to treating glaucoma patients using ELT. In various embodiments, energy shots from an excimer laser are delivered by a fiber probe at locations that form a line or a curve across Schlemm's canal. In some examples, the method includes a pre-operative analysis 7110, which may include diagnosing ocular disease, examining and / or visualizing the anterior chamber of the eye to aid in laser probe placement, etc. In various embodiments, excimer laser trabeculotomy (ELT) is used to treat glaucoma.

[0310] In some embodiments, the method includes anesthetizing the patient 7120. Local anesthesia is generally used, usually administered by instilling a local anesthetic, such as tetracaine or lidocaine, into the eye. Lidocaine and / or long-acting bupivacaine anesthetics may be injected into the area surrounding the eye cone (peribulbar block) or behind the eye cone (retrobulbar block), thereby more completely immobilizing the extraocular muscles and minimizing pain. Optionally, a facial nerve block may be performed using lidocaine and bupivacaine to inhibit eyelid closure. In some cases, general anesthesia is administered with cardiovascular monitoring, for example, in children, patients with traumatic eye injuries, and nervous or uncooperative patients or animals. Appropriate sterile precautions must be taken to prepare the surgical site, including the use of antiseptics such as povidone-iodine, sterile drapes, gowns, and gloves. In some cases, an eyelid speculum is inserted to maintain eyelid open.

[0311] The physician makes a small incision in the patient's eye at 7130. Before performing the ELT procedure, a small incision is made in the cornea of ​​the eye to allow for the introduction of a fiber probe. Typically, the incision is about 1 / 8 inch or less.

[0312] In an excimer laser trabeculotomy procedure, a physician guides the delivery tip of a fiber probe through a corneal incision in the eye and into the trabecular meshwork. The delivery tip is then guided by the physician at 7140 to successive positions across Schlemm's canal, where shots are delivered (see, e.g., FIG. 43 and the accompanying description). A goniolens, endoscope, and / or illumination source may be used by the physician to assist in positioning the delivery tip. By positioning the laser probe at multiple shot positions across or intersecting Schlemm's canal, energy from the excimer laser is delivered to multiple heights where Schlemm's canal is likely to be located, thereby increasing the likelihood that a perforation will actually connect through the trabecular meshwork to Schlemm's canal. Thus, positioning the delivery tip at a position that intersects Schlemm's canal achieves optimal photoablation and perforation formation in the trabecular meshwork and / or Schlemm's canal.

[0313] Once the delivery tip reaches the predetermined position at successive traverse locations, the physician administers ELT treatment to the patient by delivering (irradiating) a series of shots of laser energy to the trabecular meshwork and Schlemm's canal at 7150. The physician applies pulsed photoablative energy. In some instances, the physician creates approximately 10 ELT treatment sites per patient's eye. In some instances, the physician creates more than approximately 10 ELT treatment sites per patient's eye. The formation of each opening is confirmed by a small amount of blood reflux from Schlemm's canal. The fiber probe is removed from the eye. The IOP decreases immediately after administering the ELT treatment.

[0314] After administering the ELT treatment, the physician closes the incision at 7160. Typically, the physician uses sutures to close the incision. Some physicians suture the incision, while others refrain from suturing in case of persistent leakage.

[0315] The method of various embodiments includes analyzing the post-operative results at 7170 and reporting the results to the surgical patient and / or scheduling a post-operative follow-up appointment with the patient at 7180. For example, the physician's analysis may include checking each opening by observing for a small amount of blood reflux from Schlemm's canal. By observing blood reflux and aqueous humor drainage, the physician can immediately confirm the effectiveness of the laser treatment. The physician can then report the results to the patient, prescribe post-operative medications such as topical antibiotic and steroid eye drops, and schedule a post-operative follow-up appointment with the patient. Typically, topical antibiotic and steroid eye drops are prescribed and used by the patient for one to two weeks after surgery.

[0316] FIG. 43 is a partial perspective view of the anatomy within the anterior chamber of the eye, showing the same corneoscleral angle as FIG. 2 , with the locations of shots delivered to the trabecular meshwork indicated by (x) and forming a straight line across it. As described herein, the ELT procedure is performed by creating perforations in the trabecular meshwork 9, 13 of the eye. This allows fluid in stream 1 to pass through the trabecular meshwork 9, 13 and enter Schlemm's canal 11, thereby reducing intraocular pressure. As shown, the trabecular meshwork 9, 13 has a height of distance A, and Schlemm's canal 11, hidden beneath the trabecular meshwork 9, 13 and invisible to the ELT operator, may have a height B. Because the operator cannot see Schlemm's canal 11 beneath the trabecular meshwork 9, 13, one or more shots may miss Schlemm's canal, potentially resulting in a failed or less effective ELT procedure. If the operator delivered shots in a straight line, all of the shots may miss Schlemm's canal, potentially resulting in treatment failure.

[0317] 43, shots 7205, 7210 are delivered in a line across Schlemm's canal, ensuring that at least some of the shots are delivered accurately and reliably form a perforation through the trabecular meshwork 9, 13 to Schlemm's canal 11. In other words, because shots 7205 and 7210 are delivered in a line across width C where the trabecular meshwork 9, 13 and Schlemm's canal 11 are actually aligned, some of those shots (e.g., shot 7205) are delivered successfully, which helps increase the likelihood of a successful procedure.

[0318] In the example of FIG. 43 , a total of nine shots (x) are shown, of which at least six were successful, and a seventh shot located on the borderline may also be successful. Thus, firing consecutive shots along a line that crosses Schlemm's canal can ensure that at least some shots are successful, increasing the number of successful outcomes. This method may be particularly useful when the patient's Schlemm's canal is small or when the operator has poor visibility in a particular eye. In other words, instead of guessing the location of Schlemm's canal, the operator can employ a systematic approach, such as that shown in FIG. 43 , to ensure a successful procedure. In various embodiments, if a certain number of successful shots or successful perforation is required, the total number of shots can be increased. In this way, the operator can account for the number of potentially unsuccessful shots. For example, in FIG. 43 , nine shots are fired, of which at least six are successful. If at least 10 successful shots are required, the operator can fire, for example, 15 shots or more than 10 shots, leaving room for some unsuccessful shots along the cross-sectional line.

[0319] [Personalizing Excimer Laser Fiber] Glaucoma is a group of eye diseases that cause damage to the optic nerve and lead to vision loss. While glaucoma can occur at any age, it is more common in older people and is one of the leading causes of blindness in people over the age of 60. The main risk factor for glaucoma is increased intraocular pressure, where pressure inside the eye is higher than normal. Elevated intraocular pressure can lead to atrophy of the optic nerve, subsequent visual field loss, and ultimately blindness if left untreated.

[0320] Intraocular pressure correlates with the production of aqueous humor by the eye's ciliary processes and its drainage through a structure called the trabecular meshwork. The trabecular meshwork is a region of tissue in the eye located around the base of the cornea that drains aqueous humor into an intraocular lymphatic-like vessel called Schlemm's canal. The drained aqueous humor is then transported by Schlemm's canal to the bloodstream. Proper flow and drainage of aqueous humor through the trabecular meshwork maintains a normal, balanced state of ocular power. In open-angle glaucoma, the most common type of glaucoma, degeneration or blockage of the trabecular meshwork can slow or completely prevent aqueous humor drainage, leading to the accumulation of aqueous humor and increased intraocular pressure. This pressure strain can damage and ultimately cause necrosis of optic nerve fibers, resulting in permanent vision loss.

[0321] Early treatment can slow or stop the progression of glaucoma. Depending on the type of glaucoma, treatment options may include eye drops, oral medications, surgery, laser treatment, or any combination of these. For example, treatment for open-angle glaucoma may include surgical treatments such as filtration surgery, which creates an opening in the sclera of the eye and removes a portion of the trabecular meshwork, or surgical implantation of a stent or implant (i.e., drainage tube), which places a small tube shunt within the eye to facilitate fluid drainage. However, such treatments are highly invasive and can cause many complications, such as leakage, infection, and hypotony (e.g., low intraocular pressure), requiring long-term postoperative monitoring to prevent late complications.

[0322] Recently, minimally invasive laser treatments have been used to treat glaucoma. In such treatments, surgeons use lasers to thermally modify and / or completely penetrate various tissues, such as the trabecular meshwork and / or Schlemm's canal. For example, laser trabeculotomy is a procedure in which a surgeon guides the working end of a laser fiber through a corneal incision in the eye, near the trabecular meshwork, and then applies laser energy to destroy portions of the trabecular meshwork and create channels in the meshwork, allowing aqueous humor to flow more freely into Schlemm's canal. Minimally invasive laser treatments require high precision. For example, surgeons must be able to properly position the laser fiber relative to the trabecular meshwork and Schlemm's canal and ensure that the perforations or channels created by the laser are optimal. However, current laser fiber options are limited. Most laser fibers are similar in structure and function. As a result, surgeons have few options when selecting a laser fiber. Rather, surgeons are forced to use laser fibers that lack certain characteristics that the surgeon needs when performing a particular procedure, such as the desired feel, feedback, and overall functionality of the laser fiber. As a result, the laser treatment may be insufficient, the desired drainage may not be achieved, and the patient may require additional postoperative treatment to reduce intraocular pressure. For example, with current laser fiber options, surgeons may place the laser too close to the trabecular meshwork and Schlemm's canal, too far from them, or at an improper angle relative to the trabecular meshwork and Schlemm's canal, which may result in unintended collateral tissue damage or the creation of an insufficient channel that does not provide the desired drainage.

[0323] Various embodiments provide personalized laser probes for use with a laser system. The laser probes are single-use, disposable probes configured for use with a laser unit. The laser unit includes a laser source for generating laser energy that is delivered to a laser probe coupled thereto. Each laser probe is a handheld device having a handheld body and an optical fiber including an optical fiber core extending through the body. The optical fiber core is configured to transmit laser radiation from the laser source to a delivery tip of the probe upon coupling the laser probe to the laser unit, thereby transmitting the laser energy to a desired treatment site. Each laser probe includes one or more features tailored to a particular user (e.g., a surgeon or other medical professional performing a procedure involving laser therapy).

[0324] The specific features of any probe are based on the individual user's preferences. These features may generally relate to the shape and / or size of each portion of the probe, as well as the physical properties of each portion of the probe. In some embodiments, the handheld body of a particular probe may have specific dimensions, such as width, length, and diameter, based on the surgeon's individual preferences to improve fit and handling. In some embodiments, the profile of the fiber optic core delivery tip may be shaped based on the surgeon's preferences, where the tip may be beveled at a desired angle to allow for more precise control of the procedure. In some embodiments, the distal end of the laser probe may have a specific degree of flexibility or rigidity based on the surgeon's preferences, further providing improved handling and maneuverability throughout the procedure.

[0325] Personalizing the laser probe provides surgeons with a personalized fit, feel, and functionality. It prepares surgeons to properly perform specific procedures that may be difficult due to the lack of differentiation between laser fiber options. In particular, the laser probes and laser units of various embodiments can be used to permanently treat glaucoma using laser trabeculotomy. Providing a personalized laser probe allows surgeons to experience unprecedented ease of use and perform procedures with the necessary precision to ensure optimal laser treatment of the target area. In particular, using a personalized laser probe, surgeons can better position the laser radiation across Schlemm's canal to create perforations, thus creating channels, improving fluid drainage and increasing aqueous humor flow, thereby reducing intraocular pressure. Positioning the laser probe across Schlemm's canal provides optimal results by increasing the surface area for laser photoablation, improving perforation and therefore fluid drainage.

[0326] Various embodiments provide personalized laser probes for use with a laser system. The laser probes are single-use, disposable probes configured for use with a laser unit. The laser unit includes a laser source for generating laser energy that is delivered to a laser probe coupled thereto. Each laser probe is a handheld device including a handheld body and an optical fiber including an optical fiber core extending through the body. The optical fiber core is configured to direct laser radiation from the laser source to a delivery tip of the probe upon coupling the laser probe to the laser unit, thereby transmitting the laser energy to a desired treatment site.

[0327] Each laser probe includes one or more features tailored to a particular user (e.g., a surgeon or other medical professional performing a procedure involving laser therapy). Personalizing the laser probe provides the surgeon with a personalized fit, feel, and functionality. The surgeon can be better prepared to properly perform a particular procedure that may be difficult due to the lack of differentiation between laser fiber options. In particular, the laser probe and laser unit according to various embodiments can be used to permanently treat glaucoma using laser trabeculotomy. By providing a personalized laser probe, the surgeon can find the laser probe easier to use and perform the procedure with the necessary precision to ensure optimal laser treatment of the target site. In particular, using a personalized laser probe, the surgeon can better position the laser radiation across Schlemm's canal to create a perforation, thus forming a channel, improving fluid drainage and increasing aqueous humor flow, thereby reducing intraocular pressure. Positioning the laser probe across Schlemm's canal provides a larger surface area for laser photoablation, resulting in optimal results and improved perforation and therefore fluid drainage.

[0328] The systems of various embodiments may be well suited for intraocular procedures where laser treatment of target tissue is desired. In particular, the laser sources and laser probes of various embodiments may be used to treat glaucoma and may be useful for performing laser trabeculotomy. However, it should be noted that systems consistent with the present disclosure may be used for the laser treatment of any of a variety of conditions, including other conditions of the eye (i.e., diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, age-related macular degeneration, retinal breaks, and cases of retinopathy of prematurity, as well as laser in situ keratomileusis (LASIK) to correct refractive errors such as myopia (nearsightedness) or astigmatism), as well as other conditions in general practice and other medical fields (non-ophthalmology).

[0329] FIG. 44 illustrates an excimer laser system including a laser unit system 8100 and multiple laser probes 8200(1), 8200(2), and 8200(n) coupleable to the laser unit system 8100. The system 8100 includes a laser source 8102 for generating laser energy and a controller 8108 for controlling the output of the laser energy. The laser source 8102 includes an excimer laser 8104 and a gas cartridge 8106 for providing an appropriate gas combination to the laser 8104. The excimer laser 8104 is a form of ultraviolet laser, which generally operates in the UV spectral region and generates nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cartridge 8106) is generally a gas mixture including a noble gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under suitable conditions of electrical stimulation and high pressure, pseudo-molecules called excimers (or exciplexes in the case of rare gas halides) are created, which can only exist in an excited state and generate laser light in the UV range.

[0330] Laser action in excimer molecules occurs because the excimer molecules have a bonded (associative) excited state but a repulsive (dissociative) ground state. Rare gases, such as xenon and krypton, are highly inert and do not normally form compounds. However, when excited (induced by an electric discharge or a high-energy electron beam), rare gases can form temporarily bonded molecules with themselves (excimers) or with halogens, such as fluorine or chlorine (exciplexes). The excited compounds release excess energy through spontaneous or stimulated emission, becoming highly repulsive ground-state molecules that very rapidly (on the order of picoseconds) dissociate back into two unbonded atoms. This creates a population inversion. The excimer laser 8104 in this system 8100 is a XeCl excimer laser emitting at a wavelength of 308 nm.

[0331] As described in more detail herein, many of the components of laser unit system 8100 are contained in a housing, such as a movable platform, that is located in the environment where the procedure will be performed (e.g., an operating room, a treatment room, an outpatient clinic, etc.), and probes 8200(1)-8200(n) can be connected to the housing for use during treatment. When probe 8200 is connected to the housing, an optical fiber core of probe 8200 is coupled to laser source 8102 and is configured to direct laser radiation from laser source 8102 through the fiber to the treatment site.

[0332] The controller 8108 allows an operator (i.e., a surgeon or other medical professional) to control the output of a laser light signal (from the excimer laser 8104 to the optical fiber core of the probe 8200) and also to control the transmission of laser energy from the probe 8200. The controller 8108 may include software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, an instruction set, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as hard-coded (e.g., non-volatile) code, instructions or instruction sets, and / or data in a memory device. As used in any embodiment herein, "circuitry" may include, for example, hardwired circuitry, programmable circuitry such as a computer processor with one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by a programmable circuitry, alone or in any combination. For example, the controller 8108 may include a hardware processor coupled to a non-transitory computer-readable memory that stores instructions executable by the processor that cause the controller to perform various functions of the laser system 8100 described herein.

[0333] FIG. 4 illustrates one embodiment of an excimer laser unit 100 (e.g., laser system 8100) provided in an instrument 400. As previously described, one or more components of system 100 may be housed within instrument 400. In this embodiment, a laser source 8102 (including an excimer laser 8104 and a gas cartridge 1806) and a controller 8108 are housed within a housing 402. The housing 402 has wheels 404 for portability. The instrument 400 further includes a push / pull handle 405 to aid in the portability of the instrument 400. The instrument 400 further includes a connection port 406 for receiving the connection end of a laser probe 8200, thereby establishing a connection between the optical fiber core of the probe 8200 and the laser source 8102. The instrument 400 also includes various input features for an operator, such as an emergency stop button 410 and a power switch 412. The instrument 400 further includes a foot pedal 414 extending from the housing 402 and operable to control shot delivery from the excimer laser 8104 to the optical fiber core of the probe 8200. The instrument 400 further includes a display 416, which may take the form of an interactive user interface. In some examples, the interactive user interface displays patient information, machine settings, and treatment information. As previously mentioned, an operator may manually input laser probe data via the interactive user interface, thereby providing such data to the controller 8108. However, in some embodiments, data may be automatically read from a readable device or label on the probe 8200 via an associated reader in the system 8100.

[0334] As shown, various embodiments provide multiple customized laser probes 8200(1)-8200(n) for use with the excimer laser unit 8100. The laser probes 8200(1)-8200(n) are single-use, disposable probes configured for use with the laser unit one at a time. Upon coupling the laser probe 8200 to the laser unit (via connecting portion 406), the fiber optic core of the probe 8200 is configured to direct laser radiation from the excimer laser 8104 to the delivery tip of the probe for transmitting laser energy to a desired treatment site. As described in more detail herein, each laser probe 8200(1)-8200(n) may include one or more features tailored to a specific user (e.g., a surgeon or other medical professional performing a procedure involving laser therapy). To achieve this, only one excimer laser unit 8100 is required, and multiple probes 8200(1) to 8200(n) that can be used with the unit 8100 are each configured differently.

[0335] 5 and 6 illustrate one embodiment of a probe 500 (e.g., one of probes 8200(1)-8200(n)) that can be used with an excimer laser system 8100. FIGS. 46 and 47 illustrate cross-sectional views of the probe 500 taken along lines AA and BB, respectively, in FIG. 6. As shown, an optical fiber core 518 extends through the probe 500 and forms part of the connector 502. A protective sheath 516 surrounds the optical fiber core 518. In some examples, the protective sheath 516 is a plastic or rubber protective sheath. The optical fiber core 518 also forms part of the delivery tip 506 of the probe 500. A metal jacket 520 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, a stainless steel jacket 520 surrounds and protects the optical fiber core 518.

[0336] Each laser probe includes one or more features tailored to a given user (e.g., a surgeon or other medical professional performing a procedure involving laser therapy). The particular features of the probe are based on the individual preferences of the given user. These features may generally relate to the shape and / or size of each portion of the probe, as well as the physical characteristics of each portion of the probe. In some embodiments, the handheld body 508 of a given probe may have specific dimensions, such as width, length, and diameter, based on the individual preferences of the surgeon to improve fit and handling.

[0337] In some embodiments, the profile of the fiber optic core delivery tip 506 can be configured based on surgeon preference. The tip may be beveled at a desired angle to allow for more precise control of the procedure. FIG. 48 shows a close-up of the distal portion of the probe. FIGS. 49A and 49B show close-ups of probe delivery tips 506 with different bevel angles 507. For example, as shown in FIG. 49A, bevel angle θ1 can be greater than bevel angle θ2, as determined by the user's individual preference. Additionally or alternatively, the distal end of the laser probe may have a particular degree of flexibility or stiffness based on the surgeon's preference, providing improved feel and maneuverability during the procedure. For example, FIGS. 50 and 51 show close-ups of the probe distal portion 506a that bends in different directions (bent distal portion 506b). As such, the outer jacket 520 surrounding the fiber optic core 518 may comprise a particular material with properties that achieve the desired flexibility or stiffness.

[0338] Personalizing the laser probe provides surgeons with a personalized fit, feel, and functionality. Surgeons can be better prepared to successfully perform certain procedures that may be difficult due to the lack of differentiation between laser fiber options. In particular, the laser probes and laser units of various embodiments can be used to permanently treat glaucoma using laser trabeculotomy. For example, in a laser trabeculotomy procedure using a laser system and probe, a physician guides the delivery tip of the probe through a corneal incision in the eye and near the trabecular meshwork. A goniolens and / or illumination source can be used by the physician to assist in positioning the delivery tip. In some instances, the physician uses a light source, such as a goniolens, endoscope, or other illumination source, to assist in adjusting the probe's position.

[0339] By providing a personalized laser probe, surgeons can experience unprecedented ease of use and perform procedures with the necessary precision to ensure optimal laser treatment of the target area. For example, surgeons can better position the laser radiation across Schlemm's canal. Once the delivery tip is positioned across Schlemm's canal, the physician delivers a series of shots of laser energy to the trabecular meshwork. By positioning the laser probe across or intersecting Schlemm's canal, the laser is delivered to a larger surface area than when the laser is positioned parallel or perpendicular to Schlemm's canal. Thus, positioning the delivery tip across Schlemm's canal achieves optimal photoablation and channel formation in the trabecular meshwork and / or Schlemm's canal. When creating channels in tissue, the orientation and placement of the delivery tip are crucial, as optimal drainage occurs when channels in the trabecular meshwork are positioned across Schlemm's canal. Positioning the laser probe across Schlemm's canal provides a large surface area for laser photoablation, resulting in optimal results and improved perforation and therefore improved fluid drainage.

[0340] [Improved fiber probe for ELT] Glaucoma patients experience decreased vision due to fluid buildup in the anterior chamber of the eye. Fluid buildup increases intraocular pressure and causes damage to the optic nerve. If left untreated, optic nerve damage can lead to blindness.

[0341] Traditional medications prescribed to treat glaucoma do not provide a permanent solution and instead manage symptoms by lowering intraocular pressure. For example, some medications reduce fluid production, while others increase fluid drainage. Traditional surgical treatments are also used to reduce intraocular pressure, for example, by inserting an implant into the eye to increase drainage. However, these procedures have associated risks, such as implant loss.

[0342] Various embodiments provide systems and methods for treating glaucoma using a fiber probe that allows the number of laser shots used in an excimer laser trabeculotomy (ELT) procedure to be programmed. ELT is a minimally invasive method of treating glaucoma that does not involve an implant. Instead, ELT uses an excimer laser to create permanent perforations in the eye's drainage system, increasing fluid drainage. ELT devices require a fiber probe to deliver laser pulses to the eye. In various embodiments, a fiber probe connected to an ELT device can be programmed to deliver a variable number of laser shots and can monitor the number of shots delivered by the probe, thereby enabling personalized treatment of glaucoma.

[0343] Existing fiber probes can operate with a fixed number of laser shots. Typically, a maximum number of laser shots is delivered by each existing fixed-use fiber probe. If the physician requires more than 10 laser shots for treatment, the ELT procedure is interrupted to exchange the fixed-use fiber probe for another fixed-use fiber probe.

[0344] Because ELT procedures often require more than the standard number of laser shots for treating glaucoma, various embodiments provide a programmable fiber probe to increase the maximum number of laser shots for each probe. Programming the fiber probe can avoid interruptions in the ELT procedure, such as delays caused by replacing a used fixed-use fiber probe with an unused fixed-use fiber probe to continue treating the eye. Thus, various embodiments avoid interruptions to the surgical process to perform equipment changes.

[0345] In various embodiments, the method and system allow the fiber probe to be programmed to deliver a variable number of laser shots and to monitor the number of shots delivered by the probe. In various embodiments, the fiber probe can be programmed when connected to an ELT instrument. The ELT instrument includes an interactive user interface, or display panel controller, communicatively coupled to the controller and processor. Settings entered by a user into the interactive user interface are processed and implemented.

[0346] In one example, a physician uses an interactive user interface to input a numerical value representing the number (variable number) of laser shots that can be delivered by the probe. The numerical value of the variable number of laser shots is programmable within a range and can be adjusted from a minimum number to a maximum number. For safety, the manufacturer can set a predetermined limit for the maximum number of shots. The physician can program the variable number of laser shots that can be delivered, as long as it does not exceed the maximum number set by the manufacturer. The ELT device programs the variable number of laser shots that can be delivered by the fiber probe and then monitors the number of laser shots delivered by the fiber probe. Thus, various embodiments provide personalized glaucoma treatment, advantageously preventing the reuse of medical devices and avoiding the disadvantage of patients not receiving treatment in an optimal manner.

[0347] In some instances, the variable number of laser shots that can be delivered is determined based on a preoperative analysis performed by a physician. For example, a physician may determine a subject's glaucoma status and decide to deliver 15 laser shots per eye using ELT treatment. The physician can then program the fiber probe accordingly, perform the ELT procedure, and deliver the same number of laser shots without interrupting treatment to replace the fiber probe. In this manner, various embodiments described herein provide personalized laser surgical intervention, improving the efficiency of ELT treatments and preventing delays due to fiber probe replacement.

[0348] In an ELT procedure, after programming the fiber probe, the physician guides the fiber probe's delivery tip through a corneal incision in the eye and near the trabecular meshwork. In some instances, various embodiments further include anesthetizing the subject before creating the incision and inserting the probe. Typically, the incision is about 1 / 8 inch long or less. In some instances, one or more sutures are used to close the incision after the ELT treatment. The physician guides the delivery tip into a position across Schlemm's canal, creating permanent perforations in the trabecular meshwork and / or Schlemm's canal. The laser creates perforations in the trabecular meshwork and / or Schlemm's canal, immediately improving drainage of fluid from the anterior chamber of the eye. These perforations also increase blood flow and reduce intraocular pressure. In some cases, the physician uses a goniolens, endoscope, or other illumination source to assist in the placement of the fiber probe's delivery tip.

[0349] When the delivery tip is positioned across Schlemm's canal, a series of shots of laser energy are delivered to the trabecular meshwork. By positioning the laser probe across or intersecting Schlemm's canal, the energy from the laser can be delivered to a larger surface area than if the fiber probe were positioned parallel or perpendicular to Schlemm's canal. Positioning the delivery tip across Schlemm's canal provides optimal photoablation and evacuation perforation formation.

[0350] To improve drainage of aqueous humor from the anterior chamber of the eye, the ELT procedure uses a laser to create multiple permanent perforations in the trabecular meshwork and / or Schlemm's canal. Each ELT perforation has a diameter of approximately 200 μm, which is determined by the dimensions of the delivery tip. These dimensions can be modified to increase or decrease the diameter of the ELT perforations. Existing fiber probes used in ELT procedures are configured to deliver a fixed maximum number of laser shots. For example, the maximum fixed number may be 10 laser shots. In various embodiments, a physician can program the number of laser shots that can be delivered by the fiber probe, thereby providing a fiber probe with a set number of laser shots. This number of laser shots is programmable within a range, adjustable from a minimum to a maximum number. According to various embodiments, a physician can attach the fiber probe to an ELT device and input the range of laser shots that can be delivered by the attached fiber probe using the device's interactive user interface. In some examples, the number of laser shots that can be delivered is variable. In some instances, the variable number of shots that can be delivered is greater than about 10 shots.

[0351] In one example, after examining a subject with glaucoma, a physician determines that each eye requires 15 treatment shots. Using various embodiments, the physician programs the fiber probe to deliver 15 laser shots, the maximum number of laser shots that can be delivered by the probe. In such a scenario, the physician treats the subject's first eye for glaucoma using the fiber probe programmed to deliver 15 laser shots. For sterilization, a second fiber is programmed and used to deliver 15 laser shots to the subject's second eye. Thus, in the ELT procedure, the physician uses two fiber probes, one for each eye. In contrast, if the physician used a conventional fixed-number fiber probe with a maximum fixed number of shots of 10, twice as many fiber probes would be used for the same ELT treatment plan. A first fixed number probe is used to deliver up to 10 shots to the first eye, the first fixed number probe is replaced with a second fixed number probe, and the remaining 5 shots of the treatment plan are delivered to the first eye. This process is repeated to treat the subject's second eye, using a third fixed number probe to deliver up to 10 shots to the second eye, and a fourth fixed number probe to deliver the remaining 5 shots of the treatment plan to the second eye.

[0352] In one embodiment, the interactive user interface input options are for the laser's pulse, width, and amplitude settings. Due to safety concerns, the maximum settings for each of the pulse, width, and amplitude are typically predefined by the manufacturer. The user can select a value within the predetermined range set by the manufacturer.

[0353] Various embodiments use a 308 nm xenon chloride ultraviolet excimer laser. The 308 nm xenon chloride ultraviolet excimer laser minimizes thermal damage compared to visible or infrared lasers. In some instances, the excimer laser is a sealed xenon chloride (XeCl) excimer laser, such as the EXTRA LASER manufactured by MLase AG. Because ELT is a non-thermal procedure, no post-operative tissue reaction is demonstrated or activated in the trabecular meshwork. Because ELT does not generate heat, post-operative activation of tissue reaction is minimal, resulting in long-term, consistent pressure reduction.

[0354] Furthermore, to prevent corneal absorption of the laser radiation, an optical fiber is used to deliver (irradiate) the energy. The delivery tip of the fiber probe includes an optical fiber coated with a metal such as stainless steel. In some examples, the delivery tip is angled (e.g., at 0°, 15°, 30°, and 45° relative to the tip). The fiber probe includes an optical fiber suitable for UV light, which is embedded in a handheld laser applicator. In some examples, the FIDO LASER APPLICATOR manufactured by MLase AG is used as the fiber probe.

[0355] Various embodiments of the systems and methods herein treat glaucoma using excimer laser trabeculotomy (ELT). A patient is exposed to multiple shots from an excimer laser to create holes, or perforations, in the trabecular meshwork and / or Schlemm's canal. ELT gasifies the trabecular meshwork tissue through photoablation. Creating permanent perforations in Schlemm's canal and / or trabecular meshwork allows for immediate drainage of fluid that has accumulated in the eye. Furthermore, the increased blood flow and drainage of fluid from the perforations can prevent vision loss due to subsequent buildup and optic nerve damage.

[0356] Existing fiber probes used in ELT procedures are set to deliver a maximum fixed number of laser shots. Various embodiments allow a physician to program the number of laser shots that can be delivered by the fiber probe, thereby providing a fiber probe capable of delivering a variable number of laser shots. Once the delivery tip is positioned to cross Schlemm's canal, the physician applies pulsed optical ablative energy to create ELT treatment sites, i.e., perforations, in the trabecular meshwork and / or Schlemm's canal. In some instances, physicians create more than about 10 ELT treatment sites per eye.

[0357] 52 shows a flowchart of one embodiment 9100. Various embodiments relate to treating a patient with glaucoma using ELT. In various embodiments, an energy shot delivered from an excimer laser is positioned to traverse Schlemm's canal. In some examples, the method includes a pre-operative analysis 9110, which may include diagnosing the condition of the eye, examining and / or visualizing the anterior chamber to aid in laser probe placement, and analyzing the number of laser shots required for treatment. In various embodiments, excimer laser trabeculotomy (ELT) is used to treat glaucoma.

[0358] The method of various embodiments includes programming 9120 the number of shots that can be delivered by the fiber probe. With existing fiber probes used in ELT procedures, the fiber probe is set to deliver a maximum fixed number of laser shots. The method and system of various embodiments allows a physician to program the number of laser shots that can be delivered by the fiber probe. This number of laser shots is programmable within a range and can be adjusted from a minimum to a maximum number. A physician can attach the fiber probe to an ELT device and program the fiber probe to deliver a range of laser shots using the device's interactive user interface and the ELT system's controller and processor.

[0359] Some embodiments of the method include anesthetizing the patient 9130. Local anesthesia is commonly used, usually administered by instilling a local anesthetic, such as tetracaine or lidocaine, into the eye. Lidocaine and / or long-acting bupivacaine anesthetics may be injected into the area surrounding the eye cone (peribulbar block) or behind the eye cone (retrobulbar block), thereby more completely immobilizing the extraocular muscles and minimizing pain. Optionally, a facial nerve block may be performed using lidocaine and bupivacaine to inhibit eyelid closure. In some cases, general anesthesia is administered with cardiovascular monitoring, for example, in children, patients with traumatic eye injuries, and nervous or uncooperative patients or animals. Appropriate sterile precautions must be taken to prepare the surgical site, including the use of antiseptics such as povidone-iodine, sterile drapes, gowns, and gloves. In some cases, an eyelid speculum is inserted to maintain eyelid open.

[0360] The method of various embodiments further includes a physician forming a small incision 9140 in the patient's eye. Prior to performing the ELT procedure, a small incision is made in the cornea of ​​the eye to allow for the introduction of a laser probe. Typically, the incision is approximately 1 / 8 inch or smaller. During the ELT procedure, the physician guides the delivery tip of the fiber probe through the corneal incision in the eye near the trabecular meshwork. The delivery tip is guided by the physician to a position that intersects Schlemm's canal. A gonio lens, endoscope, and / or illumination source may be used by the physician to assist in the placement of the delivery tip. By positioning the laser probe across or intersecting Schlemm's canal, the laser is delivered to a larger surface area than if the laser were positioned parallel or perpendicular to Schlemm's canal. Therefore, positioning the delivery tip across Schlemm's canal provides optimal photoablation and perforation formation in the trabecular meshwork and / or Schlemm's canal. The orientation and placement of the delivery tip are critical when creating formations in tissue. Positioning the perforations in the trabecular meshwork transversely to Schlemm's canal provides optimal drainage.

[0361] Once the delivery tip is positioned so as to cross Schlemm's canal, the physician administers ELT treatment to the patient at 9150 by delivering a series of shots of laser energy into the trabecular meshwork and Schlemm's canal. The physician applies pulsed optical ablative energy to create an ELT treatment site, i.e., a perforation, in the trabecular meshwork and / or Schlemm's canal. Unlike conventional fiber probes, which have a fixed maximum number of laser shots that can be delivered, the methods of various embodiments allow the physician to program the number of shots that can be delivered by the fiber probe. The number of laser shots that can be delivered by the fiber probe according to the methods and systems of various embodiments is programmable within a range, adjustable from a minimum number to a maximum number.

[0362] In some instances, the physician uses a programmed fiber probe to create approximately 10 or more ELT treatment sites in the patient's eye. Each opening is confirmed by a small amount of blood reflux from Schlemm's canal. The fiber probe is then removed from the eye. Notably, IOP decreases immediately after the ELT treatment.

[0363] After administering the ELT treatment, the physician closes the incision at 9160. Typically, the physician uses sutures to close the incision. Some physicians suture the incision, while others refrain from suturing in case there is persistent leakage.

[0364] The method of various embodiments includes analyzing 9170 the post-operative results and communicating the results to the patient and / or scheduling a post-operative follow-up appointment with the patient 9180. For example, the physician's analysis may include observing a small amount of blood reflux from Schlemm's canal to confirm an opening. By observing blood reflux and aqueous humor drainage, the physician can immediately confirm the effectiveness of the laser treatment. The physician can then communicate the results to the patient, prescribe post-operative medications such as topical antibiotic and steroid eye drops, and schedule a post-operative follow-up appointment with the patient. For example, topical antibiotic and steroid eye drops may be used on the patient for one to two weeks after surgery.

[0365] FIG. 53 illustrates a typical embodiment of an interactive user interface 9410 (e.g., 416 in FIGS. 4, 21, 32, 45, 6310 in FIG. 41, etc.) according to various embodiments. The interactive user interface 9410 is an interactive display screen of the ELT device. The interactive user interface 9410 is communicatively coupled to a controller that allows a user (e.g., a physician) to use the interactive user interface 9410 to view and change settings, such as via haptic feedback technology and / or touchscreen technology. The interactive user interface displays various information and settings, such as patient information, device information, and device settings.

[0366] Different information is displayed on multiple switchable display screens. For example, one screen may display fiber probe configuration information, as shown in FIG. 53, while another screen displays patient information. A user can view different screens by returning to the previous screen using button 9425 or advancing to the next screen using button 9427. In the embodiment shown in FIG. 53, fiber probe configuration screen 9411 is shown. Display box 9413 specifies the setting for the maximum number of laser shots for the fiber probe. Display box 9415 shows the maximum number of laser shots entered by the user. To change the set maximum number of laser shots, a user can select button 9417 to increase the number in box 9415 or select button 9419 to decrease the number in box 9415. Display box 9421 shows the number of laser shots fired from the probe, with the changing value shown in box 9423. In the embodiment shown in FIG. 53, the fiber probe is programmed to deliver (irradiate) a maximum number of laser shots of 12, and it is shown that the fiber probe has delivered (irradiated) 8 laser shots so far.

[0367] In one embodiment, the input options on the display screen are for laser pulse, width, and amplitude settings. Due to safety concerns, maximum settings for each of pulse, width, and amplitude can be predefined by the manufacturer. The user can select a value within a predetermined range set by the manufacturer.

[0368] [Incorporated by reference] References and citations to other documents, such as patents, patent applications, patent publications, journals, books, publications, web content, etc., are made throughout this disclosure, all of which are incorporated herein by reference in their entirety for all purposes.

[0369] [Equivalent] Various modifications of the various embodiments described herein, and many further embodiments thereof, in addition to those shown and described herein, will be apparent to those skilled in the art from the entire contents of this document, including the references to the scientific and patent documents cited herein. The subject matter of this specification contains important information, examples, and guidance that can be adapted to the practice of various embodiments and their equivalents.

Claims

1. A device for irradiating the surface of the trabecular meshwork of the eye with laser energy, Insert a probe into the eye, Multiple holes are formed in the trabecular meshwork by irradiating multiple positions along the trabecular meshwork with laser energy shots via the probe. It is configured in such a way, The plurality of perforations form straight or curved lines that cross the Schlemm's canal of the eye. Device.

2. The apparatus according to claim 1, wherein the laser energy is emitted from an excimer laser source.

3. The aforementioned multiple perforations are formed in the trabecular meshwork to treat glaucoma, or The apparatus according to claim 1, wherein at least one of the plurality of perforations in the trabecular meshwork is not aligned with the Schlemm tube.

4. The apparatus according to claim 1, wherein at least one of the plurality of perforations in the trabecular meshwork does not form a fluid communication between the Schlemm's canal and the ocular chamber located between the cornea and the lens of the eye.

5. The apparatus according to claim 1, wherein at least one of the plurality of perforations in the trabecular meshwork is aligned with the Schlemm tube.

6. The apparatus according to claim 1, wherein at least one of the plurality of perforations in the trabecular meshwork forms a fluid communication between the Schlemm's canal and the endochorium of the eye located between the cornea of ​​the eye and the lens of the eye.

7. The apparatus according to claim 1, wherein a light source including a goniol lens, an endoscope, or other illumination source assists in adjusting the position of the probe.

8. The aforementioned multiple shots include 10 shots per eye, The aforementioned multiple shots include more than 10 shots per eye, The diameter of each of the aforementioned multiple perforations is approximately 200 μm, or The apparatus according to claim 1, wherein the probe is inserted into the incision of the eye.

9. The apparatus according to claim 1, further comprising analyzing the effectiveness of the shot by visualizing the drainage of aqueous humor and its backflow into the blood.

10. The apparatus according to claim 1, wherein the probe is an optical fiber probe.

11. The laser energy is emitted from an excimer laser source including a xenon chloride laser, or The method further includes physically bringing the probe into contact with the trabecular meshwork while irradiating the plurality of shots, wherein the plurality of perforations are formed when the probe is in physical contact with the trabecular meshwork. The apparatus according to claim 1.

12. A device for irradiating the surface of the trabecular meshwork of the eye with laser energy, A probe is inserted into the eye of a subject with glaucoma. The probe is positioned at a first location near the trabecular meshwork of the eye. A first shot from the laser source is irradiated to form a first perforation in the fiber column. The probe is positioned at a second location near the trabecular meshwork, and A second shot from the laser source is irradiated to form a second perforation in the trabecular meshwork, wherein the first perforation and the second perforation form a line that crosses Schlemm's canal of the eye. A device configured in such a way.

13. The placement of the probe is adjusted to a subsequent position near the trabecular meshwork of the eye, The process involves irradiating the fiber trabecular strip with subsequent shots from the laser source to form subsequent perforations, It further includes, The first perforation, the second perforation, and the subsequent perforations form a straight or curved line that crosses the Schlemm's canal of the eye. The apparatus according to claim 12.

14. The apparatus according to claim 12, wherein the laser source includes an excimer laser source.

15. A device for treating glaucoma by irradiating the surface of the trabecular meshwork of the eye with laser energy, Excimer laser source, A probe configured to be connected to the excimer laser source, A delivery chip connected to the probe, Includes, The aforementioned probe It is inserted into the eye of a subject with glaucoma. It moves to a first position near the trabecular meshwork of the eye, A first shot from the excimer laser source is irradiated to form a first perforation in the fiber trabecular strip. It moves to a second position near the trabecular meshwork, and A second shot from the excimer laser source is irradiated to form a second perforation in the fiber trabecular strip. It is configured in such a way, The first and second perforations described above form lines that cross the Schlemm's canal of the eye. Device.

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