System and method for prophylactic treatment of eye using excimer laser unit

Abstract

A method of treating an ophthalmic patient includes determining that the patient is at risk of developing glaucoma during a preoperative analysis of the patient. The method further includes treating the patient with an excimer laser to prophylactically treat glaucoma based on a preoperative analysis that the patient has a risk of developing glaucoma. The systems and methods also involve treating a patient with closed-angle glaucoma or narrow-angle glaucoma using an excimer laser unit. Systems and methods also relate to a combined excimer laser and phacoemulsification unit for treating the eye. The systems and methods also involve applying excimer laser energy in lateral placement with respect to the scleral venous sinus in the eye.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit and priority of U.S. Patent Application No. 17 / 899,285, filed on August 30, 2022; U.S. Patent Application No. 17 / 899,310, filed on August 30, 2022; U.S. Patent Application No. 17 / 899,330, filed on August 30, 2022; and U.S. Patent Application No. 17 / 899,350, filed on August 30, 2022, the entire contents of each of which are incorporated herein by reference in their entirety. Background of the Invention

[0003] Glaucoma is a group of eye diseases that cause damage to the optic nerve and lead to vision loss. Although glaucoma can occur at any age, it is more common in the elderly and is one of the leading causes of blindness in people over 60 years old. Glaucoma may be caused by intraocular pressure (IOP) that is higher than normal within the eye, where the elevated IOP can lead to optic nerve atrophy, subsequent visual field disorders, and ultimately blindness if left untreated. Summary of the Invention

[0004] An illustrative method of treating a patient with an eye disease includes determining during a pre - operative analysis of the patient that the patient has a risk of developing glaucoma. The method further includes, based on the pre - operative analysis finding that the patient has a risk of developing glaucoma, treating the patient with an excimer laser to prophylactically treat glaucoma.

[0005] In various embodiments, during the pre - operative analysis, the patient is diagnosed with cataracts and has a risk of developing glaucoma.

[0006] In various embodiments, the application of excimer laser energy to prophylactically treat glaucoma occurs when the patient is not diagnosed with glaucoma.

[0007] In various embodiments, the application of excimer laser energy to prophylactically treat glaucoma occurs before an elevated intraocular pressure (IOP) is identified in the patient's eye.

[0008] In various embodiments, the application of excimer laser energy to prophylactically treat glaucoma while the patient does not actually have glaucoma.

[0009] In various embodiments, the risk is a congenital risk.

[0010] In various embodiments, the congenital risk is related to the patient's family history, race, gender, or a combination thereof.

[0011] In various embodiments, the risk is an existing comorbidity.

[0012] In various embodiments, the co-morbidities present include ocular hypertension, obesity, diabetes, angle-closure glaucoma, smoking, alcohol consumption, or a combination thereof.

[0013] In various embodiments, the risk is an age-related risk.

[0014] In various embodiments, the age-related risks include being equal to or older than 40 years old, equal to or older than 45 years old, equal to or older than 50 years old, equal to or older than 55 years old, equal to or older than 60 years old, equal to or older than 65 years old, equal to or older than 70 years old, equal to or older than 75 years old, or older than 80 years old.

[0015] In various embodiments, the method includes: determining that a patient has cataracts during a pre-operative analysis of the patient and applying phacoemulsification ultrasound to a patient diagnosed with cataracts.

[0016] In various embodiments, the phacoemulsification ultrasound and treating the patient with an excimer laser to prophylactically treat glaucoma are performed during the same surgical procedure on the patient.

[0017] In various embodiments, the phacoemulsification ultrasound and treating the patient with an excimer laser to prophylactically treat glaucoma are applied through the same incision in the patient's eye.

[0018] In various embodiments, the method includes administering an anesthetic to the patient prior to applying the phacoemulsification ultrasound and the excimer laser.

[0019] In various embodiments, treating the patient with an excimer laser includes applying an emission of pulsed energy from the excimer laser.

[0020] An illustrative method of treating a patient with an eye disease includes determining during a pre-operative analysis of the patient that the patient is at risk of developing glaucoma. The method further includes applying phacoemulsification ultrasound to the patient through an incision in the patient's eye, the patient having been diagnosed with cataracts in the eye. The method also includes applying excimer laser energy through the incision in the eye to prophylactically treat glaucoma based on a pre-operative analysis determination that the patient is at risk of developing glaucoma.

[0021] In various embodiments, the risk is a congenital risk related to the patient's family history, race, gender, or a combination thereof.

[0022] In various embodiments, the risk is an age-related risk or a co-morbidity present.

[0023] An illustrative 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 be connected 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 who does not have glaucoma. During a preoperative analysis of the subject, it has been determined that the subject is at risk of developing glaucoma. The probe is further configured to deliver emissions from the excimer laser source to create perforations in the trabecular meshwork.

[0024] An illustrative method for treating a patient with an eye disease includes determining that the patient has angle-closure glaucoma or narrow-angle glaucoma. The method further includes treating angle-closure glaucoma or narrow-angle glaucoma during a surgical procedure performed on the patient. The method further includes: during the surgical procedure, treating the patient with an excimer laser to create a plurality of perforations in the trabecular meshwork by applying a plurality of pulses from the excimer laser to the trabecular meshwork.

[0025] In various embodiments, treating angle-closure glaucoma or narrow-angle glaucoma includes applying phacoemulsification ultrasound to the patient.

[0026] In various embodiments, phacoemulsification ultrasound includes fragmenting the lens of the eye.

[0027] In various embodiments, the method includes removing the lens from the patient's eye after fragmenting the lens.

[0028] In various embodiments, the method includes replacing the lens of the eye with an intraocular lens after removing the lens.

[0029] In various embodiments, the intraocular lens is thinner than the lens of the eye removed from the eye.

[0030] In various embodiments, the intraocular lens provides a path for fluid drainage between the intraocular lens and the iris of the eye.

[0031] In various embodiments, angle-closure glaucoma or narrow-angle glaucoma results in at least partial obstruction of fluid flow through the trabecular meshwork from the anterior chamber of the eye, which is located between the cornea of the eye and the lens of the eye, due to the bulging of the iris of the eye.

[0032] In various embodiments, treatment of angle-closure glaucoma or narrow-angle glaucoma results in a reduction in the bulging of the iris.

[0033] In various embodiments, treating the patient with an excimer laser occurs after the reduction in the bulging of the iris.

[0034] In various embodiments, treating the patient with an excimer laser includes inserting an excimer laser probe into an incision in the patient's eye.

[0035] In various embodiments, treating angle-closure glaucoma or narrow-angle glaucoma includes inserting a phacoemulsification ultrasound probe into an incision in a patient's eye.

[0036] In various embodiments, the incision has a length of about one-eighth of an inch or less.

[0037] In various embodiments, the multiple pulses include at least ten emissions.

[0038] In various embodiments, the method further includes administering an anesthetic to the patient before treating angle-closure glaucoma or narrow-angle glaucoma and before treating the patient with an excimer laser.

[0039] In various embodiments, the excimer laser includes an excimer laser source.

[0040] An illustrative 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 includes applying phacoemulsification ultrasound to the patient during a surgical procedure on the patient to treat the angle-closure glaucoma or narrow-angle glaucoma. The phacoemulsification ultrasound is applied via a phacoemulsification probe inserted through an incision in the patient's eye. The method further includes, during the surgical procedure, treating the patient with an excimer laser to create a plurality of perforations in the trabecular meshwork by applying multiple pulses from the excimer laser to the trabecular meshwork. The multiple pulses are applied via an excimer laser probe inserted through the incision.

[0041] In various embodiments, the phacoemulsification ultrasound includes fragmenting the lens of the eye.

[0042] In multiple embodiments, treating the patient with an excimer laser occurs after applying the phacoemulsification ultrasound.

[0043] An illustrative 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 be coupled to the excimer laser source. The device further includes a delivery tip coupled to the probe. The probe is configured to be inserted into the eye of a subject having angle-closure glaucoma or narrow-angle glaucoma. The probe is further configured to be inserted into the eye after performing the treatment of the angle-closure glaucoma or narrow-angle glaucoma on the subject. The probe is further configured to deliver emissions from the excimer laser source to create perforations in the trabecular meshwork.

[0044] An illustrative device for treating an eye includes a housing, an excimer laser source within the housing, an ultrasonic generator within the housing, a flushing source within the housing, and a suction source within the housing.

[0045] In various embodiments, the housing is a single housing.

[0046] In various embodiments, the device further includes wheels attached to the housing such that the device is movable.

[0047] In various embodiments, the device further includes two foot pedals, or the housing includes two sockets, each socket being configured to receive a connector for a foot pedal.

[0048] In various embodiments, the excimer laser source can be controlled using a first one of the two foot pedals.

[0049] In various embodiments, at least one of an ultrasonic generator, a flushing source, or a suction source can be controlled using a second one of the two foot pedals.

[0050] In various embodiments, the device further includes a single power cord connected to the housing and connectable to a wall outlet.

[0051] In various embodiments, each of an excimer laser source, an ultrasonic generator, a flushing source, and a suction source is powered via a single power cord.

[0052] In various embodiments, the device further includes a port for connecting an excimer laser probe to the housing.

[0053] In a plurality of different embodiments, the port is a first port, and wherein the device further includes a second port for connecting an ultrasonic phacoemulsification probe to the housing.

[0054] In a plurality of different embodiments, the ultrasonic generator, the flushing source, and the suction source are configured together for use with the ultrasonic phacoemulsification probe to perform ultrasonic phacoemulsification on a subject's eye.

[0055] In various embodiments, the excimer laser source is configured for use with an excimer laser probe to perform an excimer laser trabeculostomy (ELT) procedure on a subject's eye.

[0056] In various embodiments, the device further includes a display on the housing.

[0057] In various embodiments, the device further includes an energy monitor port on the housing.

[0058] In various embodiments, the energy monitor port is configured to receive a first distal end of an ultrasonic phacoemulsification probe and is configured to receive a second distal end of an excimer laser probe.

[0059] In multiple different embodiments, the device further includes a sensor in the energy monitor port, the sensor being 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 excimer laser probe, respectively.

[0060] An illustrative device for treating an eye includes a housing and an excimer laser source within the housing, the excimer laser source being configured to perform excimer laser trabeculostomy (ELT). The device further includes a component configured to perform phacoemulsification ultrasound, the component including an ultrasonic generator within the housing, a flushing source within the housing, and a suction source within the housing.

[0061] In various embodiments, the device further includes a single power cord connected to the housing and connectable to a wall outlet.

[0062] In multiple different 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.

[0063] An illustrative method for treating an eye includes performing excimer laser trabeculostomy (ELT) with an excimer laser source housed in a single housing. The method further includes performing phacoemulsification ultrasound with a component housed in the single housing. The components include an ultrasonic generator within the housing, a flushing source within the housing, and a suction source within the housing.

[0064] An illustrative method of delivering laser energy to the surface of the trabecular meshwork of an eye includes inserting a probe into the eye and delivering emissions of laser energy via the probe at multiple locations along the trabecular meshwork to create multiple perforations in the trabecular meshwork. The multiple perforations form a line or curve transverse to the Schlemm's canal in the eye.

[0065] In various embodiments, the laser energy is delivered from an excimer laser source.

[0066] In various embodiments, multiple perforations are created in the trabecular meshwork to treat glaucoma.

[0067] In various embodiments, at least one of the multiple perforations in the trabecular meshwork is not aligned with the Schlemm's canal.

[0068] In various embodiments, at least one of the multiple perforations in the trabecular meshwork does not create a fluid connection between the Schlemm's canal and the anterior chamber of the eye located between the cornea and the lens of the eye.

[0069] In various embodiments, at least one of the multiple perforations in the trabecular meshwork is aligned with the Schlemm's canal.

[0070] In various embodiments, at least one of the plurality of perforations in the trabecular meshwork forms a fluid connection between the sinus venosus sclerae and the anterior chamber of the eye located between the cornea of the eye and the lens of the eye.

[0071] In various embodiments, a light source, including a gonioscope, an endoscope, or other light source, facilitates adjustment of the placement of the probe.

[0072] In various embodiments, the plurality of pulses includes 10 pulses per eye.

[0073] In various embodiments, the plurality of pulses includes more than 10 pulses per eye.

[0074] In various embodiments, each of the plurality of perforations has a diameter of about 200 μm.

[0075] In various embodiments, the probe is inserted into an incision in the eye.

[0076] In various embodiments, the method further includes analyzing the effectiveness of the emission by visualizing the drainage of aqueous humor and the reflux of blood.

[0077] In various embodiments, the probe is an optical fiber probe.

[0078] In various embodiments, laser energy is delivered from an excimer laser source including a xenon chloride laser.

[0079] In various embodiments, the method further includes: while delivering the plurality of pulses, physically contacting the trabecular meshwork with the probe. The plurality of perforations are created when the probe physically contacts the trabecular meshwork.

[0080] An illustrative method of delivering laser energy to the surface of the trabecular meshwork of an eye includes inserting a probe into the eye of a subject having glaucoma and adjusting the placement of the probe to a first position proximate the trabecular meshwork in the eye. The method further includes delivering a first charge 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 proximate the trabecular meshwork. The method further includes delivering a second charge from the laser source to create a second perforation in the trabecular meshwork. The first perforation and the second perforation form a line extending transversely to the sinus venosus sclerae of the eye.

[0081] In various embodiments, the method further includes: adjusting the placement of the probe to a subsequent position proximate the trabecular meshwork, and delivering a subsequent emission from the laser source to create a subsequent perforation in the trabecular meshwork. The first perforation, the second perforation, and the subsequent perforation form a line or curve extending transversely to the sinus venosus sclerae of the eye.

[0082] In various embodiments, the laser source includes an excimer laser source.

[0083] An illustrative device for delivering laser energy to the surface of the trabecular meshwork of an eye to treat glaucoma includes an excimer laser source and a probe configured to be connected 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 having glaucoma, moved to a first position proximate to the trabecular meshwork in the eye, emit a first pulse from the excimer laser source to create a first perforation in the trabecular meshwork, moved to a second position proximate to the trabecular meshwork, and emit a second pulse from the excimer laser source to create a second perforation in the trabecular meshwork. The first perforation and the second perforation form a line extending transversely to the sinus venosus sclerae of the eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0084] Figure 1 is a schematic cross-sectional view of an eye showing internal anatomy.

[0085] Figure 2 is a partial perspective view of the anatomy within the anterior chamber of the eye, depicting the corneoscleral angle.

[0086] Figure 3 shows the excimer laser system of the present disclosure.

[0087] Figure 4 shows an embodiment of the excimer laser system.

[0088] Figure 5 shows an embodiment of a probe for use with an excimer laser system.

[0089] Figure 6 shows an embodiment of a probe for use with an excimer laser system.

[0090] Figure 7 is a schematic cross-sectional view of an embodiment within the eye.

[0091] Figure 8 shows a schematic cross-sectional view of an eye with light source assistance.

[0092] Figure 9 is an enlarged schematic cross-sectional view of an embodiment.

[0093] Figure 10 is a flowchart of an embodiment of a method for applying ELT after preoperative analysis.

[0094] Figure 11 is a flowchart of an embodiment for performing preoperative analysis and ELT treatment of a patient.

[0095] Figure 12A and 12BShows normal eyes and eyes with angle-closure glaucoma.

[0096] Figure 13 Shows an embodiment of a system for phacoemulsification and ELT treatment.

[0097] Figure 14 Shows an embodiment of a system for combined phacoemulsification and ELT treatment.

[0098] Figure 15 Shows an embodiment of a phacoemulsification system.

[0099] Figure 16 Shows an embodiment of a phacoemulsification probe.

[0100] Figure 17 Shows an embodiment of a foot pedal.

[0101] Figure 18 Shows an embodiment of a foot pedal.

[0102] Figure 19 Shows an embodiment of a foot pedal.

[0103] Figure 20 Shows an embodiment of a foot pedal.

[0104] Figure 21A Shows an embodiment of a combined ELT and phacoemulsification system.

[0105] Figure 21B Shows an embodiment of a combined ELT and phacoemulsification system.

[0106] Figure 22 Shows along Figure 6 A cross-sectional view of the probe taken along line A-A.

[0107] Figure 23 Shows along Figure 6 A cross-sectional view of the probe taken along line B-B.

[0108] Figure 24 Shows an enlarged view of the delivery tip of a probe that emits both visible light for illuminating the field of view and laser energy for photoablation of target tissue.

[0109] Figure 25 Shows along Figure 6 An alternative cross-sectional view of the probe taken along line A-A.

[0110] Figure 26 Shows along Figure 6 An alternative cross-sectional view of the probe taken along line B-B.

[0111] Figure 27 Shows an excimer laser system of the present disclosure.

[0112] Figure 28 Shows the authentication of an excimer laser system of the present disclosure and a laser probe used with the excimer laser system.

[0113] Figure 29 Shows an embodiment of a probe used with an excimer laser system.

[0114] Figure 30 Shows a cross-sectional view of the probe taken along line A-A Figure 4 thereof.

[0115] Figure 31 Shows a cross-sectional view of the probe taken along line B-B Figure 4 thereof.

[0116] Figure 32 Shows an embodiment of a laser probe connected to an excimer laser unit.

[0117] Figure 33 Shows an enlarged view of the connection between the laser probe and the excimer unit and the initial RFID reading for determining the laser probe authentication.

[0118] Figure 34 Is a flowchart of an embodiment for verifying a probe used with an excimer laser unit.

[0119] Figure 35 Is a flowchart of an embodiment for preventing the use of an unauthenticated probe with an excimer laser unit.

[0120] Figure 36 Shows an excimer laser system of the present disclosure.

[0121] Figure 37 Shows an excimer laser system of the present disclosure and how the system is used to calibrate the laser output to compensate for increased variations in the optical fiber of the laser probe.

[0122] Figure 38 Illustrates the process of calibrating the laser output, including adjusting the laser energy output from the laser source to the laser probe to account for variations in the core of the optical fiber of the laser probe.

[0123] Figure 39 Shows an embodiment of a probe used with an excimer laser system.

[0124] Figure 40 Is a flowchart of an embodiment of a method for applying ELT after a previous ineffective treatment.

[0125] Figure 41Shows an implementation of an ELT system with an interactive user interface.

[0126] Figure 42 Is a flowchart of an implementation of a method of creating perforations using placement of a probe, the perforations forming lines transverse to the trabecular meshwork.

[0127] Figure 43 Is a partial perspective view of the anatomy within the anterior chamber of the eye, depicting the corneoscleral angle, where pulses are applied to the trabecular meshwork along a transverse line.

[0128] Figure 44 Shows an excimer laser system of the present disclosure.

[0129] Figure 45 Shows an implementation of an excimer laser unit.

[0130] Figure 46 Shows a cross-sectional view of a probe taken along line A-A Figure 6 of.

[0131] Figure 47 Shows a cross-sectional view of a probe taken along line B-B Figure 6 of.

[0132] Figure 48 Shows an enlarged view of the distal portion of the probe.

[0133] Figure 49A And Figure 49B Shows an enlarged view of the delivery tip of a probe having different bevel angles.

[0134] Figure 50 And 51 Shows an enlarged view of the distal portion of a probe bent in different directions.

[0135] Figure 52 Is a flowchart of an implementation of a method of applying an ELT with programmable customization.

[0136] Figure 53 Shows a stylized implementation of an interactive user interface. Detailed Description

[0137] A major risk factor for glaucoma is elevated intraocular pressure, where the pressure inside the eye is higher than normal. The elevated intraocular pressure can lead to optic nerve atrophy, subsequent visual field disturbances, and ultimately blindness if left untreated.

[0138] Intraocular pressure is a function of the aqueous humor fluid produced by the ciliary processes of the eye and its drainage through a tissue called the trabecular meshwork. The trabecular meshwork is a tissue area in the eye located around the base of the cornea and is responsible for draining aqueous humor into a lymphatic-like blood vessel in the eye called the canal of Schlemm, which then delivers the drained aqueous humor to the bloodstream. The proper flow and drainage of aqueous humor through the trabecular meshwork maintains the normal balance of pressure within the eye. In open-angle glaucoma (the most common type of glaucoma), degeneration or blockage of the trabecular meshwork can cause a slowdown or complete blockage of aqueous humor drainage, causing fluid accumulation, which increases intraocular pressure. Under the strain of this pressure, optic nerve fibers become damaged and may eventually die, resulting in permanent vision loss.

[0139] If treated early, the progression of glaucoma can be slowed or stopped. Depending on the type of glaucoma, treatment options can include eye drops, oral medications, surgery, laser treatment, or a combination of any of these. For example, the treatment of open-angle glaucoma can include surgical treatments such as filtration surgery, where an opening is created in the sclera of the eye and a portion of the trabecular meshwork is removed, and surgical implantation of a stent or implant (i.e., a drainage tube), where a tube shunt is positioned within the eye to assist in fluid drainage. However, such treatments are highly invasive and can have many complications, including leakage, infection, low intraocular pressure (e.g., hypotony), and require long-term postoperative monitoring to avoid late complications.

[0140] Recently, minimally invasive laser treatments have been used to treat glaucoma. In such treatments, a surgeon uses a laser to thermally modify and / or completely pierce various structures, including the trabecular meshwork and / or the canal of Schlemm. For example, laser trabeculostomy is a procedure where a surgeon guides the working end of a laser fiber through an incision in the cornea of the eye and toward the trabecular meshwork and applies laser energy to disrupt portions of the meshwork to create channels in the meshwork that allow aqueous humor to flow more freely into the canal of Schlemm.

[0141] To fully understand the various embodiments described herein, a brief overview of the anatomy of the eye is provided. Figure 1 is a schematic cross-sectional view of an eye showing the internal anatomy. As shown, the outer layer of the eye includes the sclera 17, which serves as the support framework of the eye. The front portion of the sclera includes the cornea 15, which is 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 continuously flowing transparent fluid called aqueous humor 1. The lens 4 is connected to the eye by zonular fibers that are attached to the ciliary body 3. In the anterior chamber 7, the iris 19 surrounds the outer perimeter of the lens 4 and includes a pupil 5 at its center. The pupil 5 controls the amount of light passing through the lens 4. The posterior chamber 2 is located between the lens 4 and the retina 8.

[0142] Figure 2A partial perspective view of the anatomical structures within the anterior chamber of the eye, depicting the corneoscleral angle. As shown, the anatomical structures of the eye further include the trabecular meshwork 9, which is a narrow band of spongy tissue surrounding the iris 19 within the eye. The trabecular meshwork has a variable shape and is microscopic in size. It has a triangular cross-section and a thickness that varies within the range of 100 - 200 microns. It is composed of different fiber layers with pores of micron size, and the pores of micron size form a fluid path for the outflow of aqueous humor. The trabecular meshwork 9 has been measured to be approximately 100 microns thick at its anterior border, the Schwalbe line 18, which is at the approximate junction of the cornea 15 and the sclera 17.

[0143] The trabecular meshwork widens to approximately 200 microns at its base, where the trabecular meshwork and the iris 19 attach to the scleral spur. The channels through the pores in the trabecular meshwork 9 lead through a very thin porous tissue called the juxtacanalicular trabecular meshwork 13, which in turn abuts the medial side of a structure called the scleral venous sinus 11. The scleral venous sinus 11 is filled with a mixture of aqueous humor and blood components and branches into collecting channels 12 that drain the aqueous humor into the venous system. Since aqueous humor is continuously produced by the eye, any obstruction in the trabecular meshwork, juxtacanalicular trabecular meshwork, or scleral venous sinus prevents the easy escape of aqueous humor from the anterior chamber, which results in an increase in intraocular pressure within the eye.

[0144] The eye has a drainage system for draining aqueous humor 1 located in the corneoscleral angle. Generally, the ciliary body 3 produces aqueous humor 1. The aqueous humor flows from the posterior chamber 2 through the pupil 5 into the anterior chamber 7, then into the trabecular meshwork 9, then into the scleral venous sinus 11, then into the collecting channels 12, and then into the aqueous vein. The obstruction of aqueous humor outflow that occurs in most open-angle glaucoma (i.e., glaucoma characterized by an easily visible trabecular meshwork under gonioscopy) is usually confined to the region of the juxtacanalicular trabecular meshwork 13, which is located between the trabecular meshwork 9 and the scleral venous sinus 11, more specifically, the inner wall of the scleral venous sinus. It is desirable to correct this outflow obstruction by enhancing the eye's ability to use its native drainage system.

[0145] For example, when the obstruction develops at the juxtacanalicular trabecular meshwork 13, the intraocular pressure gradually increases over time, leading to damage and atrophy of the optic nerve, subsequent visual field disturbances, and ultimately blindness if left untreated. The laser probe of the present embodiment is well-suited for treating glaucoma. Specifically, as will be described in more detail herein, the laser probe is configured to be coupled to a laser source and emit laser energy from the laser source to the trabecular meshwork 13, thereby causing photoablation of the tissue (including at least the trabecular meshwork 13 and, in some examples, also the scleral venous sinus 11) to form channels in the meshwork (and potentially the scleral venous sinus 11), thereby improving fluid drainage into the scleral venous sinus 11 and reducing the intraocular pressure in the eye.

[0146] Figure 3 Shown is an excimer laser system 100 of the present disclosure. System 100 includes a probe member 102, a controller 106, a laser source 108, and a light source 110. Probe member 102 includes a laser transmission member 103 and an illumination member 104. As will be described in more detail herein, many components of laser system 100 may be included in a housing, such as a movable platform, to be positioned in an environment (e.g., an operating room, an operating theater, an outpatient environment, etc.) where a surgery is to be performed, and probe member 102 may be connected to the housing for use during treatment. When probe member 102 is coupled to the housing, laser transmission member 103 and illumination member 104 are each coupled to a corresponding laser source 108 and light source 110. Controller 106 provides an operator (i.e., a surgeon or other medical professional) with control over the output of a laser signal (from laser source 108 to laser transmission member 103), and thereby controls the transmission of laser energy from laser transmission member 103 of probe 102. Controller 106 also provides the operator with control over the output of an optical signal (from light source 110 to illumination member 104), and thereby controls the emission of light from illumination member 104.

[0147] Controller 106 may include software, firmware, and / or circuitry configured to perform any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-volatile computer-readable storage medium. The firmware may be embodied as code, instructions, or instruction sets and / or data hard-coded (e.g., non-volatile) 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 the programmable circuitry, either individually or in any combination. For example, controller 106 may include a hardware processor coupled to a non-volatile computer-readable memory that contains instructions executable by the processor to cause the controller to perform the various functions of excimer laser system 100 as described herein, including controlling the laser and / or illumination output.

[0148] Laser source 108 may include an excimer laser 112 and a gas cylinder 114 for providing a suitable gas mixture to laser 112. Excimer laser 112 is in the form of an ultraviolet laser that typically operates in the UV spectral region and produces nanosecond pulses. The excimer gain medium (i.e., the medium contained within gas cylinder 114) is typically a gas mixture that includes an inert gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high voltage, a pseudomolecule called an excimer (or an exciplex in the case of an inert gas halide) is produced, which can only exist in an energized state and can produce a laser in the UV range.

[0149] Laser action occurs in excimers because they have a bound (associated) excited state but a repulsive (dissociative) ground state. Noble gases such as xenon and krypton are highly inert and generally do not form chemical compounds. However, when in an excited state (induced by a discharge or a high-energy electron beam), they can form transiently bound molecules with themselves (excimers) or with halogens (exciplexes) such as fluorine and chlorine. The excited compound can release its excess energy by undergoing spontaneous or stimulated emission, resulting in a strongly repulsive ground-state molecule that dissociates very rapidly (on the picosecond timescale) back into two unbound atoms. This creates a population inversion. The excimer laser 112 of the present system 100 is a XeCl excimer laser and emits a wavelength of 308 nm.

[0150] The light source 110 provides an optical signal within the visible spectrum to the illumination member 104. Thus, the light source 110 can include, but is not limited to, incandescent light sources, fluorescent light sources, halogen light sources, high-intensity discharge light sources, metal halide light sources, and light-emitting diode (LED) light sources.

[0151] Figure 4 An embodiment of an excimer laser system 100 disposed within an instrument 400 is shown. As previously described, one or more components of the system 100 can be contained within the instrument 400. In this embodiment, the controller 106, the laser source 108 (including the excimer laser 112 and the gas cylinder 114), and the light source 110 are contained within a housing 402. The housing 402 has wheels 404 and is portable. The instrument 400 also includes a push-pull handle 405, which facilitates the portability of the instrument 400. The instrument 400 also includes a connection port 406 for receiving the connection end of the probe member 102 to establish a connection between the laser transmission member 103 and the illumination member 104 and the corresponding laser source 108 and light source 110. The instrument 400 also includes various inputs for the operator, such as a fiber optic probe cap holder 408, an emergency stop button 410, and a power switch 412. The instrument 400 also includes a foot pedal 414 extending from the housing 402 and operable to provide control of the emission of the laser transmission member 103 from the excimer laser 412 to the probe 102. The instrument 400 also includes a display 416, which can be in the form of an interactive user interface. In some examples, the interactive user interface 410 displays patient information, machine settings, and program information.

[0152] Figure 5 An embodiment of a probe 500 used with the excimer laser system 100 is shown, showing the probe 500 having a capped distal delivery tip 506. Figure 6Shows an embodiment of a probe 500 in which the top cap 514 is 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 delivery member and an illumination member as previously described herein, each of which is coupled to their respective sources (i.e., laser source 108 and light source 110) by a connector 502 (elongated cord), the connector 502 extending from the body of the probe 500 and having a connection assembly 504 configured to be received within the connection port 406 of the instrument 400. The probe 500 further includes a delivery tip 506 from which laser energy (from the laser delivery member) and visible light (from the illumination member) can be emitted. The probe 500 includes a handheld body 508, the handheld body 508 may include a finger grip 510 having ridges or depressions 512. The body 508 of the handheld probe 500 can be metal or plastic.

[0153] Figure 7 Is a schematic cross-sectional view of the eye 2100, showing the internal anatomy. Figure 8 Shows a schematic cross-sectional view of the eye 2100 having a light source 2190 (such as a gonioscope, endoscope, or other light source). Figure 9 Is an enlarged schematic cross-sectional view of the eye. The outer layer or sclera 2130 serves as the support framework of the eye, and the front portion of the outer layer 2130 includes the cornea 2125, which is a transparent tissue that allows light to enter the eye. The anterior chamber 2135 is located between the cornea 2125 and the lens 2110, and the posterior chamber is located behind the lens 2110. The anterior chamber 2135 contains a continuously flowing transparent fluid called aqueous humor. In the anterior chamber 2135, the iris 2120 surrounds the outer periphery of the lens 2110 and includes a pupil at its center, which controls the amount of light passing through the lens 2110.

[0154] The eye further includes a trabecular meshwork 2140, which is a narrow band of spongy tissue that surrounds the iris 2120 within the eye. The trabecular meshwork has a variable shape and is microscopic in size. It has a triangular cross-section and has a thickness that varies in the range of 100 - 200 microns. It is composed of different fiber layers having pores of micron size, which form a fluid path for the outflow of aqueous humor. The trabecular meshwork 2140 has been measured to have a thickness of approximately 100 microns at its anterior edge, which is called the anterior limiting line, which is located at the approximate junction of the cornea and the sclera.

[0155] The trabecular meshwork widens to approximately 200 microns at its base, where the trabecular meshwork and the iris 2120 attach to the scleral spur. The channels through the pores in the trabecular meshwork 2140 lead through a very thin porous tissue called the juxtacanalicular trabecular meshwork, which abuts the medial side of a structure called the scleral venous sinus 2150. The scleral venous sinus 2150 is filled with a mixture of aqueous humor and blood components and branches into collecting channels that drain the aqueous humor into the venous system. Because aqueous humor is constantly produced by the eye, any blockage in the trabecular meshwork, the juxtacanalicular trabecular meshwork, or the scleral venous sinus prevents the aqueous humor from easily escaping from the anterior chamber, which results in an increase in intraocular pressure within the eye.

[0156] The eye has a drainage system for draining aqueous humor. The aqueous humor flows from the posterior chamber behind the lens 2110 through the pupil into the anterior chamber 2135 to the trabecular meshwork 2140 and into the scleral venous sinus 2150 to the collecting channels and then to the aqueous veins. The blockage of aqueous humor outflow that occurs in most open-angle glaucomas (i.e., glaucomas characterized by an easily visible trabecular meshwork under gonioscopy) is usually confined to the area of the juxtacanalicular trabecular meshwork located between the trabecular meshwork 2140 and the scleral venous sinus 2150, more precisely, the inner wall of the scleral venous sinus. As the blockage develops, for example, at the juxtacanalicular trabecular meshwork or the scleral venous sinus, the intraocular pressure gradually increases over time, leading to damage and atrophy of the optic nerve, subsequent visual field disturbances, and ultimately blindness if left untreated.

[0157] A laser probe is used to treat glaucoma according to various embodiments. The delivery tip of the laser probe 2160 is guided through a small incision in the cornea 2125 of the eye that is typically about 1 / 8 inch or less and through the anterior chamber 2135 to a position near the scleral venous sinus 2150. The probe is guided very flatly through the anterior chamber to avoid penetrating the cornea in the visual field. The laser probe is coupled to a laser source and emits laser energy from the laser source to the trabecular meshwork 2140 and the scleral venous sinus 2150, thereby causing photoablation of the tissue that at least includes the trabecular meshwork 2140 and in some examples includes the scleral venous sinus 2150. The photoablation from the laser energy creates perforations in the meshwork and the scleral venous sinus, thereby improving the fluid drainage into the scleral venous sinus 2150 and reducing the intraocular pressure in the eye.

[0158] Figure 9Shows the arrangement of the delivery tip 2160 at the location 2170 near the scleral venous sinus 2150. Arranging the laser at a proximal location of the scleral venous sinus allows the laser path to travel transversely through the trabecular meshwork to the scleral venous sinus. By positioning the laser near the scleral venous sinus, the laser can provide photoablation to a larger surface area of the trabecular meshwork compared to lasers arranged at positions perpendicular or parallel to the scleral venous sinus. Additionally, if the delivery tip of the laser is positioned parallel to the scleral venous sinus, the laser will not provide photoablation to any surface area of the trabecular meshwork or the scleral venous sinus.

[0159] ELT Treatment and Phacoemulsification Combined with ELT Treatment Based on Risk Factors

[0160] Many people suffer vision loss due to cataracts or glaucoma. Cataracts are a common condition that occurs when light entering the eye is blocked due to clouding or opacity in the eye's lens. Patients with glaucoma experience vision loss caused by damage to the optic nerve due to the accumulation of fluid in the anterior chamber of the eye.

[0161] The risk of developing cataracts, glaucoma, or both increases with age; and many people over 60 years old have vision-altering conditions simultaneously. Additionally, patients diagnosed with cataracts at a young age have a higher risk of developing glaucoma later in life. Patients diagnosed with either condition undergo treatment ranging from medication to surgery.

[0162] Various embodiments provide systems and methods for prophylactically treating glaucoma in patients undergoing cataract treatment. According to various embodiments, patients presenting for cataract extraction are evaluated and, if appropriate, prophylactically treated to prevent glaucoma. Various embodiments utilize the insight that certain patients with cataracts (especially at a younger age) may develop glaucoma later in life, may be in the early stages of developing glaucoma, or may be at high risk of developing glaucoma due to family history, ethnic background, underlying medical conditions, or other factors. Various embodiments include evaluating cataract patients to determine whether an additional surgery, as described below, is beneficial in preventing the onset of glaucoma. Thus, the methods of multiple embodiments include selecting patients undergoing cataract treatment for prophylactic treatment of glaucoma. It should be noted that while excimer laser trabeculostomy (ELT) surgery is the preferred prophylactic glaucoma treatment according to various embodiments herein, other surgeries known in the art may be used for prophylactic glaucoma treatment.

[0163] In various embodiments described herein, the ELT procedure can be performed prophylactically, with or without other types of treatment described herein, such as phacoemulsification treatment described below. Thus, the ELT procedure can be performed based on a patient's diagnosis that they are at high risk of developing glaucoma or have congenital or other risk factors for developing glaucoma, as described herein.

[0164] Phacoemulsification treatment (also referred to herein as "phaco") is a commonly used method for removing cataracts. Various embodiments include administering phacoemulsification and ELT during the same surgical visit, thereby minimizing the surgical volume for patients with multiple eye diseases. Because phacoemulsification and ELT are less invasive than traditional surgeries, the amount of recovery time for the patient is minimized. In fact, both phacoemulsification and ELT are performed through a small incision made within the patient's eye. In various embodiments, laser phacoemulsification surgery can be used in place of phacoemulsification treatment. In such embodiments, a laser phacoemulsification machine and / or a combined ELT / laser phacoemulsification machine can be used in the same manner as can a phacoemulsification machine and / or a combined ELT / phacoemulsification machine according to the various embodiments herein. However, in various embodiments, regardless of the type of machine used (stand-alone ELT or combined ELT / phacoemulsification machine), the ELT procedure can be performed alone (without a cataract treatment such as phacoemulsification), for example to treat glaucoma and / or prophylactically treat glaucoma, as described herein.

[0165] Any cataract treatment is sufficient for use in various embodiments. Phacoemulsification is a preferred cataract treatment, where a small incision is made in the peripheral cornea and a phaco probe is inserted. The incision is long enough to allow the phaco probe and additional instruments for removing the cataract to enter. Typically, the incision is about 1 / 8 inch long. The phaco probe breaks the cataract into small pieces, which are then removed from the eye. The phaco probe typically has a titanium or steel needle that vibrates at an ultrasonic frequency to emulsify the cataract while a pump aspirates particles through the end of the needle. To facilitate removal, the physician can use a cutting tool and a irrigator. A clear replacement intraocular lens (IOL) is then inserted through the incision.

[0166] Before closing the incision, the methods of the various embodiments allow for performing an excimer laser trabeculostomy for prophylactic treatment of glaucoma. In various embodiments, an excimer laser can be used to create perforations in the Schlemm's canal and / or trabecular meshwork of the eye, thereby allowing fluid to drain from the eye. ELT treats open-angle glaucoma at the site of occurrence by increasing the permeability of the trabecular meshwork. During ELT, the laser creates a direct connection between the anterior chamber of the eye and Schlemm's canal by using an optical fiber probe that physically contacts the trabecular meshwork. The optical fiber probe includes an optical fiber suitable for UV light embedded in a handheld laser applicator. In some examples, the FIDO laser applicator manufactured by MLase AG is used as the optical fiber probe.

[0167] The ELT procedure involves guiding the laser through a small corneal incision to the trabecular meshwork in the iridocorneal angle. A gonioscope can be used to achieve effective and precise positioning of the end of the optical fiber probe at the trabecular meshwork to create a channel into Schlemm's canal. The doctor uses the gonioscope to observe quality criteria during the operation, including reflux bleeding and mild reflux bleeding.

[0168] To achieve easier aqueous humor drainage to reduce IOP, a total of about ten ELT sites or perforations (each having a diameter of about 200 μm) are laser cut into the trabecular meshwork and / or Schlemm's canal by laser ablation or photoablation. In contrast, stents and implants have a smaller individual diameter between about 80 μm and about 120 μm. The photoablation excimer laser operates at a wavelength of 308 nm. In some examples, the excimer laser is an encapsulated xenon chloride (XeCl) excimer laser, such as the EX TRA laser manufactured by MLase AG. Since ELT is a non-thermal procedure, tissue reactions in the trabecular meshwork are not shown or activated postoperatively. The lack of heat generation in ELT allows for little activation of postoperative tissue reactions and provides long-term stability of the decompression effect. Additionally, unlike traditional glaucoma treatment methods of shunt or stent placement, the stability of Schlemm's canal treated with ELT remains unchanged.

[0169] The methods of the various embodiments include treating a subject having one or more eye diseases and providing ELT as a prophylactic treatment. Phacoemulsification ultrasound is applied to a subject having one or more eye diseases, and an excimer laser is applied to the subject's eye to increase blood flow to the subject's eye. Applying an excimer laser to the eye includes applying an emission of pulsed energy from the excimer laser. In some examples, about 10 pulses of pulsed energy are applied to the eye. In an example, one or more eye diseases include cataracts and glaucoma.

[0170] In some cases, an excimer laser is applied prophylactically to treat glaucoma. The methods of various embodiments also include administering an anesthetic to a subject prior to applying phacoemulsification ultrasound and an excimer laser. In some embodiments, the methods of various embodiments also include postoperative analysis. For example, postoperative analysis includes observing the fluid flowing out of the trabecular meshwork in the eye.

[0171] Systems of various embodiments are for treating a subject having one or more eye diseases. Systems of various embodiments are for treating cataracts and prophylactically treating glaucoma during the same surgical visit, thereby eliminating the need for multiple surgeries to treat both conditions. By prophylactically treating glaucoma, irreversible vision loss caused by glaucoma can be avoided. The system includes a phacoemulsification ultrasound system and an excimer laser system. The phacoemulsification ultrasound system includes an ultrasound probe for treating cataracts in a subject's eye. The excimer laser system includes an excimer laser and an optical fiber probe for increasing blood flow to the subject's eye. In some examples, increasing the blood flow to the eye prophylactically treats glaucoma in the subject.

[0172] In addition, the methods of various embodiments provide treatment for both conditions and can reduce the amount of medication used to manage eye diseases or eliminate the need for medication used to manage eye diseases. In an example, cataract medications are eliminated because phacoemulsification is effective in reversing vision loss due to cataracts. In an example, IOP is reduced by ELT surgery and medications for treating glaucoma are reduced or eliminated because eye drops that reduce IOP by reducing the amount of fluid produced or increasing fluid flow output are unnecessary.

[0173] In one embodiment, a physician uses the systems of various embodiments to perform phacoemulsification for treating cataracts and ELT for prophylactically treating glaucoma. An interactive user interface displays patient information, machine settings, and program information. The physician uses different instruments and probes according to the treatment procedure. For example, the doctor uses an ultrasound handpiece probe for phacoemulsification and an optical fiber probe for ELT. The optical fiber probe includes an optical fiber having a tip. In some embodiments, the tip includes an optical fiber jacketed in stainless steel. In some cases, the tip is angled. In certain embodiments, the optical fiber probe is disposable.

[0174] By using a foot pedal as the power source for each procedure, the physician is able to keep their hands free during the procedure for use with the corresponding probe and other instruments. In some embodiments, the phacoemulsification ultrasound system also includes a foot pedal for powering the application of ultrasound, irrigation, and aspiration to remove the cataract from the subject's eye. In some embodiments, the excimer laser system also includes a foot pedal for powering the excimer laser and delivering the emission from the excimer laser to the subject's eye. For example, the doctor uses the foot pedal to provide power to the optical fiber for ELT, such as by providing laser pulses.

[0175] Other instruments used by the doctor include a gonioscope, cutting tool, and irrigator. The user interface provides any suitable information. For example, the user interface provides the settings of the machine, such as the number of laser pulses administered each time the foot pedal is tapped. The user interface displays patient information or procedure information.

[0176] In some embodiments, an anesthetic is administered to the patient prior to the procedure. In some examples, the anesthesia is local. In some examples, the anesthetic includes anesthetic drops. In some cases, general anesthesia is administered to the patient. In one example, the eye is first anesthetized with eye drops, and then an anesthetic is injected around the eye to prevent pain and excessive eye movement during the procedure.

[0177] A method of treating a subject having one or more eye diseases includes: applying phacoemulsification ultrasound to a subject having one or more eye diseases; and administering an excimer laser to the subject for prophylactic treatment of glaucoma. A system for treating one or more eye diseases of a subject includes a phacoemulsification ultrasound system and an excimer laser system. The methods and systems of various embodiments prophylactically treat glaucoma in the subject. The phacoemulsification system includes an ultrasound probe for treating cataracts in the subject. The excimer laser system includes an excimer laser and an optical fiber probe that emits pulsed energy from the excimer laser into the eye.

[0178] Various embodiments provide methods and systems for treating both cataracts and glaucoma during a single surgical procedure. The methods of various embodiments treat a subject having cataracts and glaucoma with phacoemulsification (phaco) and excimer laser trabeculostomy (ELT). Phacoemulsification removes the cataract and inserts a clear replacement lens. ELT increases the flow of aqueous humor in the eye by penetrating the trabecular meshwork with a laser. Phacoemulsification and ELT are administered during the same surgical visit, thereby minimizing the surgical volume for patients with multiple eye diseases. Since phacoemulsification and ELT are less invasive than traditional surgeries, the amount of recovery time for the patient is minimized. In fact, both phacoemulsification and ELT are performed through a small incision made in the eye.

[0179] In some cases, various embodiments provide methods for treating a diagnosed eye disease and prophylactically treating a second eye disease during the same surgical procedure. For example, a patient may be diagnosed with cataracts and require phacoemulsification surgery. Because some of those with cataracts have a congenital risk of developing glaucoma, the methods of various embodiments administer prophylactic ELT treatment during the same surgical procedure as the phacoemulsification treatment. ELT provides treatment for glaucoma by increasing and / or improving the outflow of aqueous humor from the eye. Thus, a patient diagnosed with cataracts will receive treatment for both cataracts and glaucoma, two eye diseases, during the same surgical procedure.

[0180] Figure 10 A flowchart of embodiment 3100 is shown. The methods of various embodiments involve treating multiple eye diseases in a patient. In some examples, the method includes a preoperative analysis and diagnosis 3110 of the eye disease. In some embodiments, the diagnosed eye disease is cataracts and requires phacoemulsification surgery. The patient may also have glaucoma. In various embodiments, excimer laser trabeculostomy (ELT) is used to treat glaucoma. In some cases, ELT is provided as a prophylactic treatment for glaucoma because individuals with cataracts have an increased risk of developing glaucoma.

[0181] A patient with one or more eye diseases is prepared for surgery. The method includes administering anesthesia 3120 to the patient. Topical anesthesia is most commonly used and typically involves instilling a local anesthetic such as tetracaine or lidocaine. Alternatively, lidocaine and / or a longer-acting bupivacaine anesthetic can be injected into the area around (peribulbar block) or behind (retrobulbar block) the eye muscle cone to more fully immobilize the extraocular muscles and minimize pain sensation. Sometimes a facial nerve block with lidocaine and bupivacaine can be used to reduce eyelid squeezing. General anesthesia is recommended for children, traumatic eye injuries with cataracts, very anxious or uncooperative patients, and animals. Cardiovascular monitoring is preferred during local anesthesia and mandatory in the case of general anesthesia. Appropriate aseptic precautions are taken to prepare the surgical area, including using an antiseptic such as povidone iodine. Sterile drapes, gowns, and gloves are used. A plastic sheet with a container helps collect fluid during phacoemulsification. A speculum is inserted to keep the eyelids open.

[0182] The physician makes a small incision 3130 in the patient's eye. A small incision is made in the eye to allow the introduction of surgical instruments before phacoemulsification or ELT surgery can be performed. Through the small incision, treatment procedures are administered during a single surgical procedure.

[0183] The surgery includes 3140 applying phacoemulsification (phaco) treatment to the patient. Phacoemulsification is a modern cataract surgery in which the intraocular lens is emulsified with an ultrasonic handpiece and aspirated from the eye. The surgeon removes the anterior surface containing the intraocular lens capsule. The probe used during phacoemulsification is an ultrasonic handpiece with a titanium or steel needle. The tip of the needle vibrates at ultrasonic frequency and is used to sculpt and emulsify the cataract. The pump aspirates the particles through the tip of the ultrasonic handpiece. In some techniques, a second fine steel instrument called a "chopper" is used from a side port to help chop the nucleus into smaller pieces. The cataract is typically broken into two or four pieces, each piece is emulsified and aspirated with suction. Nucleus emulsification makes it easier to aspirate the particles. After all the hard central nucleus of the lens is removed by phacoemulsification, only aspiration is used to remove the softer outer lens cortex.

[0184] A irrigation-aspiration probe or a bimanual system is used to aspirate the remaining peripheral cortical material while keeping the posterior capsule intact. An intraocular lens implant (IOL) is placed in the remaining lens capsule. In some examples, the implant is a poly(methyl methacrylate) (PMMA) IOL and the incision has to be enlarged. In some examples, the implant is a foldable IOL made of silicone or acrylic and is folded using a stent, a folder, or an insertion device provided with the IOL. The IOL is inserted and placed in the posterior chamber within the capsular bag for in-the-bag implantation.

[0185] The surgery includes 3150 applying excimer laser trabeculostomy (ELT) treatment to the patient. In various embodiments, ELT and cataract surgery are performed through the same corneal incision. In some examples, the surgeon creates approximately 10 ELT sites in the patient's eye after performing phacoemulsification in the eye.

[0186] Obstruction of aqueous humor outflow at the trabecular meshwork and the inner wall of the scleral venous sinus is the main cause of elevated intraocular pressure (IOP) in open-angle glaucoma (OAG). Various embodiments use an excimer laser to perforate the scleral venous sinus. Other lasers such as ruby lasers and argon lasers cannot achieve permanent perforation of the trabecular meshwork to create an internal outflow channel instead of an external outflow channel. Although photothermal and photodisruptive lasers were initially successful in piercing the meshwork, the effect is transient due to the inflammatory and healing responses. Excimer laser trabeculostomy (ELT) reconstructs the natural aqueous humor outflow of the eye without stimulating a healing response in the target tissue.

[0187] Excimer laser ablation causes little thermal damage, thus minimizing the formation of inflammatory and scar tissue. Compared with visible light or infrared lasers, the 308 nm xenon chloride excimer ultraviolet laser causes the least thermal damage. Different from argon and selective laser trabeculoplasty, ELT precisely excises tissue without causing thermal damage or scarring of surrounding tissue. ELT treatment thus creates a long-term opening that directly connects the anterior chamber of the eye to the scleral venous sinus. To avoid corneal absorption of laser radiation, an optical fiber is used to deliver energy. The fiber optic probe or light guide fiber probe advances through the incision and through the anterior chamber of the eye to contact the trabecular meshwork. The physician can use a prone mirror or endoscope to visualize the placement of the fiber optic probe.

[0188] The physician applies pulsed photoablation energy. Typically, the physician creates 10 sites in one or two inferior quadrants. A small amount of blood reflux from the scleral venous sinus confirms each opening. The fiber optic probe is removed from the eye. Notably, the IOP decreases immediately after the ELT procedure is administered. The patient uses topical antibiotics and steroid drops for 1 to 2 weeks after the surgery.

[0189] After applying phacoemulsification and ELT treatment, the physician 3160 closes the incision. Secure closure of the incision is necessary to prevent endophthalmitis. Typically, the physician uses sutures to close the incision. Some physicians place sutures in the incision, and other physicians reserve sutures for when there is persistent leakage. The number of sutures required also depends on the type of IOL implanted during phacoemulsification surgery. For example, a foldable IOL requires few or no sutures because a foldable IOL can be inserted through an incision smaller than the incision required to insert a PMMA IOL.

[0190] The methods of various embodiments include 3170 analyzing postoperative outcomes and 3180 reporting the outcomes and scheduling postoperative follow-up for the patient after the surgery. For example, the physician's analysis may include observing a small amount of blood reflux from the scleral venous sinus to confirm each opening. In turn, the physician can report the results to the patient, prescribe postoperative medications such as topical antibiotics and steroid drops, and schedule the patient's subsequent postoperative follow-up.

[0191] Figure 11 A flowchart of an embodiment 1401 for diagnosing and performing an ELT procedure is shown. As described herein, the ELT surgery can be performed without phacoemulsification treatment or in combination with phacoemulsification treatment. Similarly, embodiment 1401 can be performed regardless of whether the patient undergoes phacoemulsification treatment. Specifically, method 1401 can be used to prophylactically treat patients to prevent them from developing glaucoma and / or elevated intraocular pressure (IOP).

[0192] Embodiment 1401 includes performing a preoperative analysis of a patient at 1402, wherein during the preoperative analysis it is determined that the patient has a congenital or otherwise elevated risk of developing glaucoma or elevated IOP. Risk factors that can be considered during the preoperative analysis at 1402 can include one or more of age, family history, race, gender, presence of comorbidities (e.g., presence of conditions associated with the risk of developing glaucoma and / or elevated IOP).

[0193] Because ELT treatment has a relatively high level of success in perforating the patient's trabecular meshwork, without a significant risk of damaging the tissue surrounding the perforation, ELT treatment is considered relatively safe and generally has a rapid recovery without complications. Thus, due to the relatively low risks associated with ELT treatment and the relatively high positive outcomes, ELT surgery can be safely performed on patients who may not yet have glaucoma and / or elevated IOP but may be at risk of glaucoma and / or elevated IOP. In other words, because ELT surgery is less invasive, ELT treatment can be performed on a greater number of patients with one or more risk factors for glaucoma and / or elevated IOP, without a high risk of side effects or treatment failure over time.

[0194] During the preoperative analysis, the risk factors being evaluated can be one or more risk factors, wherein if a risk factor (or more than one risk factor) is present, the patient can be considered to be at risk of developing glaucoma and / or elevated IOP. For example, if a patient is at or above a certain age, the patient can be determined to be at risk of developing glaucoma and / or elevated IOP, and thus can be eligible for ELT surgery during the preoperative analysis. For example, a patient can be considered to be at risk of glaucoma and / or elevated IOP at 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, if a patient has a congenital risk associated with a higher incidence of glaucoma, such as if they belong to a certain race, such as African American or Black, Latino, South Asian or Indian, East Asian (e.g., Chinese, Japanese, and / or Korean), etc., the patient can be considered to be at risk. The congenital risk can also be determined based on a family history of glaucoma and / or elevated IOP. In various examples, if a patient is a certain gender, the patient can be considered to be at risk. In various examples, if a patient has other diseases or conditions, such as ocular hypertension, obesity, diabetes, etc. (e.g., comorbidities), the patient can be considered to be at risk. In various examples, if a patient is a smoker or drinker, or if their drinking or smoking has occurred for a minimum threshold number of years, or if they drink or smoke at a frequency higher than a certain threshold, the patient can be considered to be at risk.

[0195] At 1404, if it has been determined that the patient has congenital or other sufficient risk factors for developing glaucoma and / or elevated IOP, then an ELT procedure can be performed on the patient based on preoperative analysis and determination to prophylactically prevent the onset of glaucoma and / or elevated IOP.

[0196] In various embodiments, the preoperative analysis at 1402 can also include genetic analysis or 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 may be at risk for glaucoma and / or elevated IOP.

[0197] As noted above, one risk factor can be race. A certain type of glaucoma known as angle-closure glaucoma may be more likely to occur in populations of East Asian descent (e.g., Chinese, Japanese, Korean). Thus, if the patient is of East Asian descent (with or without the identification of another risk factor), then an ELT procedure can be performed because of the risk of developing angle-closure glaucoma. Additionally, certain aspects of the patient's eye can be measured or examined to see if the patient is at risk for developing angle-closure glaucoma (e.g., monitoring or measuring the thickness of the patient's eye lens and / or the angle of the iris). Such aspects can represent a higher risk or indication of developing angle-closure glaucoma and can thus be considered risk factors for developing glaucoma and / or elevated IOP.

[0198] Angle-closure glaucoma, also known as closed-angle glaucoma, occurs when the iris of the eye bulges forward, narrowing or blocking the drainage angle formed by the cornea and the iris. As a result, fluid cannot circulate through the eye and pressure increases. This is shown in Figure 12A and 12B In Figure 12A fluid can normally move from the underside of the iris, between the iris and the lens, to the upper side of the iris and is normally drained through the trabecular meshwork. When the fluid can be drained normally, the IOP can be maintained at an appropriate level.

[0199] In Figure 12B a closed angle that can increase IOP and cause glaucoma is shown. In particular, the lens thickens, causing it to press against the iris and block the flow of fluid from under the iris to the top side of the iris. The iris may bulge further, which may further block the drainage path outside the trabecular meshwork. Thus, fluid in the eye may not be drained normally and may cause elevated IOP and glaucoma. The swelling of the iris, thickening of the lens, and accumulation of pressure under the iris can further cause pressure on the scleral venous sinus (through which fluid can be drained), thereby reducing the fluid that can flow through the scleral venous sinus.

[0200] In some individuals, as a person ages, the lens of the eye may continue to grow and thicken. Thus, during preoperative analysis, the risk of angle-closure glaucoma may be associated with certain races and certain ages of patients. One way to treat angle-closure glaucoma is by phacoemulsification surgery, in which the thickened lens of the eye is replaced with a thinner artificial lens, and the fluid drainage pathways between the lens and the iris and possibly between the iris and the trabecular meshwork can also be reopened. In this way, phacoemulsification surgery moves the iris downward, allowing access to the trabecular meshwork, and thus ELT surgery can be successful. As described herein, it may be desirable to perform phacoemulsification and ELT treatment during the same surgery. Thus, when a patient is identified as being at risk of developing angle-closure glaucoma or is being treated for angle-closure glaucoma, it may be beneficial to perform ELT treatment on the patient. In this way, fluid drainage from the eye can be improved, and if not needed, phacoemulsification surgery can be delayed, or ELT and phacoemulsification surgery can be advantageously performed together as described herein.

[0201] Thus, according to the various embodiments described herein, ELT can be performed with or without phacoemulsification surgery based on the patient's condition and the risk factors present in the patient's body. Risk factors such as congenital risk factors can be determined during the preoperative analysis of the patient and their eye to determine whether the patient is at risk of developing glaucoma and / or elevated IOP, whether the patient already has elevated IOP but does not yet have glaucoma, and so on. In other words, even if a patient has not been diagnosed with glaucoma and / or the patient does not actually have glaucoma, ELT treatment can be prophylactically applied to treat glaucoma. Similarly, if one or more risk factors are identified as being present in the patient and the patient has not been identified as having elevated IOP, ELT treatment can still be performed on the patient due to the identified risk factors.

[0202] In various embodiments, even a specific risk factor may not be identified. The trabecular meshwork of each human eye becomes more impermeable with age. Thus, after a certain age, ELT surgery can be applied to patients regardless of specific congenital risk factors. In other words, the ELT procedure can be applied completely prophylactically despite the absence (or lack of knowledge) of any specific risk factors other than age. Thus, ELT surgery can be used as a prophylactic measure even before a patient has elevated IOP or before any risk factors are identified in the patient.

[0203] Figure 13Shows a schematic diagram of a system 200 according to various embodiments. The system 200 includes an ELT instrument 201 and a phacoemulsifier 221, which are communicatively connected to a computer 205. The system 200 optionally includes a server 209 and a memory 213. Any of the included ELT instrument 201, phacoemulsifier 221, computer 205, server 209, and memory 213 can exchange data via a communication network 217. In cases where the methods of various embodiments employ a client / server architecture, a server can be used to perform the steps of the methods of various embodiments, the server including one or more of a processor and a memory, capable of obtaining data, instructions, etc., or providing results via an interface module or providing results as a file. The server can be provided by a single or multiple computer devices, such as a rack-mounted computer sold by Hitachi under the trademark BLADE. In the system 200, each computer can include at least one processor coupled to a memory and at least one input / output (I / O) mechanism.

[0204] A processor generally includes a chip, such as a single-core or multi-core chip, to provide a central processing unit (CPU). The processor can be provided by a chip from Intel or AMD.

[0205] The memory can include one or more machine-readable devices on which a set or multiple sets of instructions (e.g., software) are stored, which when executed by the processor of any of the disclosed computers, can implement some or all of the methods or functions described herein. The computers of various embodiments can include one or more I / O devices, such as a video display unit (e.g., a liquid crystal display (LCD) or a 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 generation device (e.g., a speaker), a touch screen, an accelerometer, a microphone, a cellular radio frequency antenna, and a network interface device (which can be, for example, a network interface card (NIC), a Wi-Fi card, or a cellular modem). The system 200 can be used to perform the methods described herein. Instructions for any method step can be stored in the memory, and the processor can execute those instructions.

[0206] Figure 14FIG. 0 is a diagram of a treatment system 300 according to various embodiments. The system 300 is for treating a variety of eye diseases, such as cataracts and glaucoma. The treatment system 300 includes a phacoemulsification (phaco) system 310 and an excimer laser trabeculostomy (ELT) system 360. The phacoemulsification system 310 includes a controller 320, an ultrasonic generator 330, an irrigation source and / or pump 340, and a aspiration source and / or pump 350. The phacoemulsification system 310 can be housed in an instrument. An ultrasonic probe can be connected to the phacoemulsification system and the instrument for use during phacoemulsification treatment. The excimer laser system 360 includes a controller 370, an excimer laser 380, and a gas cylinder 390. The excimer laser system 360 can be contained in a housing, and an optical fiber probe can be connected to the housing for use during ELT treatment.

[0207] Figure 4 FIG. 4 shows an embodiment of an excimer laser trabeculostomy (ELT) instrument 400. The excimer laser is contained in a housing 402. The housing has wheels 404 and is portable. A push-pull handle 405 facilitates the portability of the ELT instrument 400. A foot pedal 414 extends from the housing 402 and is operable to provide the transmitted power for delivery from the laser through the optical fiber probes 102, 104. The connectors of the optical fiber probes 102, 104 are connected to the excimer laser in the housing 402 at the optical fiber connection ports 406. The housing includes an interactive user interface 416. In some examples, the interactive user interface 416 displays patient information, machine settings, and program information. The housing 402 includes control buttons, switches, and dials, such as an optical fiber probe cap holder 408, an emergency stop button 410, and a power switch 412.

[0208] Figure 5 FIG. 8 shows a capped version of the optical fiber probe 500. Figure 6An embodiment of the probe 500 is shown, where the top cap 514 is removed, thus exposing the delivery tip 506 of the probe 500. The probe 500 is a single-use disposable unit. In some embodiments, the fiber optic probe 500 has a label for determining operability. In some examples, a radio frequency identification (RFID) tag must match the RFID on the instrument for operation. The probe 500 generally includes a laser delivery member and an illumination member as previously described herein, each of which is coupled to their respective sources (i.e., the laser source 108 and the light source 110) through a connector 502 (slender cord), and the connector 502 extends from the body of the probe 500 and has a connection assembly 504 configured to be received within the connection port 406 of the instrument 400. The probe 500 further includes a delivery tip 506 from which laser energy (from the laser delivery member) and visible light (from the illumination member) can be emitted. The probe 500 includes a handheld body 508, and the handheld body 508 may include a finger grip 510 having ridges or depressions 512. The body 508 of the handheld probe 500 can be metal or plastic. The fiber optic tip 506 at the distal end of the probe includes an optical fiber jacketed in metal (such as stainless steel or titanium). The jacketed fiber at the distal end of the probe is inserted into the trabecular meshwork of the eye. Depress the foot pedal to power the laser. When powered, the laser delivers emission from the laser that travels through the optical fiber to the trabecular meshwork and the canal of Schlemm.

[0209] Figure 15 An ultrasonic emulsification system or instrument 800 is shown. The ultrasonic emulsification instrument 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 supply energy from the ultrasonic generator to the ultrasonic probe 950. A holder 940 extends from the housing 910 to hold the ultrasonic probe 950 when the ultrasonic probe 950 is not in use. The ultrasonic probe 950 is connected to the ultrasonic generator through a connector 960. The ultrasonic emulsification instrument includes an interactive display 970 and additional controllers 980. For example, the controls 980 can be control dials or buttons and may include a power switch and an emergency stop switch. The interactive display 970 can display the irrigation flow rate, the aspiration flow rate, and the ultrasonic frequency and amplitude.

[0210] Figure 16An ultrasonic probe 1000 used during phacoemulsification is shown. The ultrasonic probe 1000 may also be referred to as a phacoemulsification probe, an ultrasonic probe, or a phacoemulsification handpiece. The phacoemulsification probe is connected to a phacoemulsification system through a connector 1040, which may be a protective plastic sheath. The protective sleeve of the connector 1040 covers the irrigation line 1010, the ultrasonic power line 1020, and the aspiration line 1030. The connector 1040 connects the phacoemulsification system to the body 1060 of the phacoemulsification ultrasonic probe 1000. The body 1060 of the ultrasonic probe 1000 optionally has a finger grip 1050 with ridges 1055. The phacoemulsification probe is sterilized by any suitable method that provides a sterilization device suitable for humans. In some embodiments, the phacoemulsification 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 cannula 1085. The needle 1095 is made of titanium or steel. The needle has an angled tip (e.g., 0°, 15°, 30°, and 45° relative to the tip). The phacoemulsification needle operates at a frequency of 40 kHz with an amplitude of 3 / 1000 inch. At the distal opening of the needle is an aspiration port 1090. The aspiration port 1090 is communicatively coupled to an aspiration source / pump and subsequently to a discharge source. The needle also has one or more irrigation ports 1080. The irrigation ports 1080 are communicatively coupled to an irrigation source / pump. A silicone irrigation cannula 1085 or silicone material covers the phacoemulsification needle tip and protects the cornea and iris from the thermal energy transmitted by the probe. In certain examples, the pumps for irrigation and aspiration are selected from peristaltic pumps, venturi pumps, and diaphragm pumps.

[0211] Figures 17 to 20 Embodiments of a foot pedal according to various embodiments are shown. In certain embodiments, the instrument includes one foot pedal for phacoemulsification surgery and one foot pedal for ELT surgery. The foot pedal has multiple positions. As Figures 17 - 20 shown, there are four positions. The initial position is when the foot pedal 1100 is not depressed, as Figure 17 shown. In Figure 18 , the foot pedal 1200 is in the first position 1110 and is slightly depressed. In Figure 19 , the foot pedal 1300 is in the second position 1120 and is moderately depressed. In Figure 20 , the foot pedal 1400 is in the third position 1130 and is fully depressed.

[0212] In one embodiment, the foot pedal is used for phacoemulsification surgery. In the first position, the phacoemulsification foot pedal provides only irrigation. In the second position, the phacoemulsification foot pedal provides irrigation and aspiration. In the third position, the phacoemulsification foot pedal provides irrigation, aspiration, and phacoemulsification power.

[0213] In one embodiment, a foot pedal is used for an ELT procedure. Each press of the foot pedal can cause one emission from the laser. For example, when the foot pedal is depressed to a first position, as Figure 18 shown, one pulse is emitted from the laser. When the foot pedal is depressed to a second position, as Figure 19 shown, one pulse is emitted from the laser. When the foot pedal is depressed to a third position, as Figure 20 shown, one pulse is emitted from the laser. Alternatively, the energy provided by the foot pedal can increase with each position of the laser. For example, at the first position, one emission can be emitted from the laser, while two pulses are emitted from the laser at the second position, and three pulses are emitted from the laser at the third position.

[0214] Although Figure 4 and Figure 15 show separate machines / systems for ELT and phacoemulsification surgery, the phacoemulsification and ELT systems can be further combined into a single machine according to the embodiments described herein. For example, Figure 21A shows a machine 1500 that includes components of both an ELT system including Figure 4 and a phacoemulsification system including Figure 15 . Such a machine can occupy less space in the operating room, which can be beneficial to allow the operator and anyone else in the operating room to have more space to maneuver. Additionally, as described herein, such a system may be advantageous in cases where phacoemulsification and ELT treatments are performed together on the same patient during the same surgery or procedure. Thus, if the machine uses a combined machine as Figure 21A shown, the operator may not have to move and switch between machines.

[0215] Figure 21AMachine 1500 is shown with a single pedal 414 that can be configured to operate and / or work with both a probe 950 for phacoemulsification treatment and probes 102, 104 for ELT treatment. In such embodiments, the operator can toggle a switch or otherwise input to machine 1500 to indicate whether they are using the ELT probes 102, 104 or the phacoemulsification probe 950. In another example, machine 1500 can be programmed or configured to determine which probe the operator is using. For example, the handle of the probe can be equipped with a touch sensor such that the pedal 414 can be used to operate only the probe being held by the operator. In another example, the probe can be further actuated by buttons or other switches on the probe in combination with the pedal such that the pedal can control only the probe on which the button or other switch thereon is depressed or otherwise activated (e.g., like a safety). In another example where the probe is actuated with the handle and buttons on the pedal 414, the buttons on the handle and the pedal can be used for different functions. For example, the pedal can be used to set the power delivered by the laser / probe and the button on the handle can be used to actually deliver a burst of energy based on the pedal's setting. In this way, machine 1500 may not accidentally fire the laser for an unused probe since the button on the probe may still have to be actuated to cause a given laser / probe to fire. In various embodiments, other combination machines for ELT and phacoemulsification treatment can have more than one pedal, such as one pedal for the phacoemulsification system / treatment and one pedal dedicated to the ELT system / treatment.

[0216] Figure 21B Another example of a combined ELT / phacoemulsification machine 981 is shown. Machine 981 can advantageously have only a single power cord 982 for plugging into an external power source. Machine 981 can include a phacoemulsification unit 983 and an ELT unit 984. Each of the phacoemulsification unit 983 and the ELT unit 984 can be at a height that is convenient for the user to insert a probe into the machine and / or remove a probe from the machine. In Figure 21BIn the example, the phacoemulsification unit 983 and the ELT unit 984 are at different heights, but are still oriented towards the top of the machine 981 for easy access by the user. In other embodiments, the phacoemulsification unit 983 and the ELT unit 984 may be oriented at the same height. The ELT unit 984 may include a display 985, a receiver 987 for connecting to an optical fiber probe, and an energy monitor 988 configured to receive the distal end of the optical fiber probe, such that the laser emitted by the probe can be received by the sensor of the machine 981 to calibrate the laser power emitted by the probe. When inserted into the energy monitor, the distal end of the probe may have a sterile adapter attached thereto, which can be discarded after calibration. In this way, the distal end of the probe to be inserted into the eye does not contact the machine 981 or the energy monitor 988. The energy monitor 988 may also have a shutter such that the sensor is only exposed when the probe is inserted and the shutter is thus pushed back. In various embodiments, a single sensor and port for calibrating the laser probe may be used for the excimer laser for ELT surgery (e.g., ELT laser, ELT assembly) and the lasers and probes used in phacoemulsification surgery. The section 986 shown in dashed lines of the machine 981 may also include other internal aspects of the machine, such as a vitrectomy assembly, a flush / aspiration assembly, feeds for both the ELT and phacoemulsification lasers, etc. The section 986 may also include or may be an access panel that allows the machine 981 to be serviced as needed.

[0217] In various embodiments, the excimer laser for performing ELT (e.g., ELT laser, ELT assembly) (and any components associated therewith described herein) may be combined with components different from those associated with the 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 diseases. For example, the excimer or ELT assembly may also be located in the same housing as the components used for femtosecond laser cataract surgery, powered by the same wires / sockets as the components used for femtosecond laser cataract surgery, etc. In such examples, the femtosecond laser is used to create an opening in the anterior layer of the eye lens, and the laser is also used to break up the cloudy lens with a cataract, which can then be aspirated. Thus, the femtosecond laser and the aspiration assembly may be included in the same housing as the excimer or ELT assembly, similar to the embodiments having the ELT and phacoemulsification assemblies described above. Thus, femtosecond laser treatment for cataracts may also be combined with ELT surgery, similar to the embodiments of combining ELT surgery with phacoemulsification surgery described herein.

[0218] Such machines can save space in the operating room and thus increase efficiency during procedures performed on patients. In various embodiments, an ELT laser can also be manufactured to fit into an existing phacoemulsification machine (or a phacoemulsification machine designed to accommodate other laser components) and then inserted into the phacoemulsification machine. Such a process can include inserting the ELT components, securing them to the phacoemulsification machine structure, and connecting the ELT components to the power output or bus of the phacoemulsification machine.

[0219] Excimer Laser Fiber Illumination

[0220] During the current laser trabeculostomy procedure, the surgeon uses a goniolens (a special contact lens prism) held above the eye in combination with light to visualize the working end of the laser fiber when positioning the laser fiber relative to the trabecular meshwork.

[0221] Although the surgeon may have some view of the target site (i.e., the trabecular meshwork), relying on the combination of the goniolens and the current light source that illuminates the target site is insufficient. In particular, the current procedure relies on an external beam (from a slit lamp) to attempt to illuminate the anterior chamber angle where the cornea and iris meet (i.e., the location of the trabecular meshwork). However, the external light source may not provide a comprehensive view within the eye and is restrictive. As a result, the surgeon cannot visually verify with certainty the position of the laser relative to the trabecular meshwork, the effectiveness of laser treatment on any given portion of the meshwork, and the drainage of aqueous humor after laser treatment. For example, without proper visualization, the surgeon may position the laser too close or too far from the trabecular meshwork and / or position the laser at an inappropriate angle relative to the trabecular meshwork, resulting in accidental collateral tissue damage or creating an inadequate channel that does not provide the desired drainage. Thus, the laser treatment may be insufficient because the desired drainage may not be achieved, and as a result, the patient may require additional postoperative procedures to reduce intraocular pressure.

[0222] The system of the embodiments herein includes a laser probe for performing intraocular surgery. The laser probe is a single-use disposable probe configured to be coupled to a laser source and transmit laser energy from the laser source to a target tissue for treatment thereof. The laser probe includes a laser transmission member and a light-emitting member in a single component. In particular, the laser probe includes an optical fiber core that includes a delivery tip for transmitting laser energy from the laser source to the target tissue during surgery. The laser probe also includes a light-emitting member that provides illumination in the field of view near the delivery tip of the optical fiber core, thereby providing a clear field of view for the surgeon during laser treatment of the target tissue.

[0223] The laser probes of the various embodiments herein can be particularly well-suited for use in a laser trabeculostomy procedure. During such a procedure, it is crucial for the surgeon to have a clear field of view within the eye, particularly at the anterior chamber angle where the cornea and iris meet, such that the position of the laser relative to the trabecular meshwork can be clearly seen. The surgeon can direct the delivery tip of the optical fiber core of the laser probe through a corneal incision in the eye and toward the trabecular meshwork. The light-emitting member emits a visible light signal within the eye and near the delivery tip, thereby illuminating the field of view in which the surgeon can better visualize the positioning of the delivery tip and subsequent transmission of laser energy onto the trabecular meshwork. By providing a laser probe with an integrated illumination member, illumination is provided internally (i.e., within the eye), as opposed to current procedures that rely on external light sources, and thus provides a more comprehensive view within the eye and an improved view of the target location. By providing an improved view, the surgeon is able to better position the delivery tip relative to the trabecular meshwork in order to achieve optimal photoablation and channel formation in the meshwork and / or the sinus venosus sclerae. In particular, the orientation and positioning of the delivery tip are critical when attempting to create optimal channel formation in the tissue, particularly when attempting to achieve the placement of the channel in the meshwork relative to the sinus venosus sclerae, which will provide optimal drainage. Additionally, the surgeon is able to more confidently visually verify the effectiveness of the laser treatment by visualizing the drainage of aqueous humor as a result of the laser treatment.

[0224] In various embodiments herein, an excimer laser probe can be provided for performing intraocular surgery. The intraocular surgery can include laser trabeculostomy, and thus the target tissue includes the trabecular meshwork and / or the sinus venosus sclerae. However, it should be noted that the laser probe consistent with the present disclosure can be used for any laser treatment of eye diseases, including but not limited to diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, cases of age-related macular degeneration, retinal tears, and retinopathy of prematurity, as well as laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism.

[0225] The laser probe can include an optical fiber core that includes a proximal end that can be coupled to an excimer laser source and a distal end that includes a delivery tip for transmitting laser energy from the excimer laser source to the target tissue for treatment. The laser probe further includes an illumination member for providing illumination in the field of view near the delivery tip of the optical fiber core.

[0226] In various embodiments, the illumination member includes an optical fiber for receiving an optical signal from a light source. The light source provides an optical signal within the visible spectrum. Thus, the light source can include, but is not limited to, incandescent light sources, fluorescent light sources, halogen light sources, high-intensity discharge light sources, metal halide light sources, and light-emitting diode (LED) light sources.

[0227] 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 also includes an outer sheath that surrounds the optical fiber and the fiber core.

[0228] Another aspect of the various embodiments described herein can be an excimer laser system for performing intraocular surgery. Again, the intraocular surgery can include laser trabeculostomy, and thus the target tissue includes the trabecular meshwork and / or the scleral venous sinus. The excimer laser system includes an excimer laser source, a light source, and a disposable probe that is operably coupled to the excimer laser source and the light source and is configured for intraocular surgery. The laser probe includes a fiber core that includes a proximal end that can be coupled to the excimer laser source and a distal end that includes a delivery tip for transmitting laser energy from the excimer laser source to the target tissue for treatment. The laser probe also includes an illumination member that is configured to receive an illumination signal from the light source and to provide illumination in the field of view proximate to the delivery tip of the fiber core.

[0229] In various embodiments, the illumination member includes an optical fiber configured to receive an optical signal from the light source. The light source provides an optical signal within the visible spectrum. Thus, the light source can 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.

[0230] 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 also includes an outer sheath that surrounds the optical fiber and the fiber core.

[0231] In various embodiments, a laser probe can be provided. The laser probe can be a single-use disposable probe that is configured to be coupled to a laser source and to transmit laser energy from the laser source to a target tissue for treating the same. The laser probe includes a laser transmission member and an illumination member in a single assembly. In particular, the laser probe includes a fiber core that includes a delivery tip for transmitting laser energy from the laser source to the target tissue during surgery. The laser probe also includes a light-emitting member that provides illumination in the field of view proximate to the delivery tip of the fiber core, thereby providing a clear field of view for the surgeon during laser treatment of the target tissue.

[0232] The laser probes of the various embodiments can be applicable to intraocular surgeries where laser treatment of a target tissue is desired. In particular, the laser probes of the various embodiments can be used to treat glaucoma and can be used to perform laser trabeculostomy. However, it should be noted that the laser probes consistent with the present disclosure can be used for any laser treatment of eye diseases, including but not limited to diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, cases of age-related macular degeneration, retinal tears and retinopathy of prematurity, and laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism.

[0233] During laser trabeculostomy, it is crucial that the surgeon has a clear view inside the eye, particularly the anterior chamber angle where the cornea and iris meet, such that the position of the laser relative to the trabecular meshwork can be clearly visualized. By using a laser probe, the surgeon can guide the delivery tip of the fiber core of the laser probe through the corneal incision of the eye and towards the trabecular meshwork. The luminescent member emits a visible light signal inside the eye and near the delivery tip, thereby illuminating the field of view in which the surgeon can visualize the positioning of the delivery tip and subsequently the transmission of laser energy onto the trabecular meshwork with the aid of a gonioscope. By providing a laser probe with an integrated illumination member, illumination is provided internally (i.e., inside the eye), which is contrary to current procedures that rely on external light sources, and thus provides a more comprehensive view inside the eye and an improved view of the target location. By providing an improved view, the surgeon is able to better position the delivery tip relative to the trabecular meshwork in order to achieve optimal photoablation and channel formation in the meshwork and / or the sinus venosus sclerae. In particular, when attempting to produce optimal channel formation in the tissue, especially when attempting to achieve the placement of the channel in the meshwork relative to the sinus venosus sclerae, the orientation and positioning of the delivery tip are critical, which will provide optimal drainage. Additionally, the surgeon is able to more confidently visually verify the effectiveness of the laser treatment by visualizing the drainage of aqueous humor as a result of the laser treatment.

[0234] As described above, Figure 4 An embodiment of an excimer laser system 100 is shown; Figure 5 An embodiment of a probe 500 used with the excimer laser system 100 is shown, showing the probe 500 having a capped distal delivery tip 506; and Figure 6 An embodiment of the probe 500 is shown where the top cap 514 is removed, thereby exposing the delivery tip 506 of the probe 500.

[0235] Figure 22 and Figure 23 respectively show along Figure 6Cross-sectional views of the probe 500 taken along lines A-A and B-B. As shown, the laser transmission member can include an optical fiber core 518 that extends through the optical fiber probe 500 and forms part of the connector 502. Similarly, the illumination member can include an optical fiber 520 that also passes through the optical 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 protective plastic or rubber 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 sheath 522 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, a stainless steel sheath 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 aligned with the optical fiber core 518, or surrounds the core 518, or in other embodiments, the core 518 can surround the optical fiber 520. In other embodiments, the optical fiber 520 is adjacent to the optical fiber core 518.

[0236] Figure 24 An enlarged view of the delivery tip 502 of the probe 500 is shown, which emits visible light (via emission from the optical fiber 520 upon receipt of an optical signal from the light source 110) and emits laser energy (via emission from the optical fiber core 518 upon receipt of a laser pulse from the laser source 108) for photoablation of target tissue.

[0237] Figure 25 and Figure 26 Alternative embodiments of the probe are shown, where cross-sectional views 530 and 536 are respectively similar to those of the probe 500 taken along Figure 6 lines A-A and B-B of Figure 22 and Figure 23 . As shown, the laser transmission member can include an optical fiber core 534 that extends through the optical fiber probe 500 and forms part of the connector 502. In this embodiment, visible light from the light source 110 of the laser system 100 can be transmitted through the optical fiber core 534 together with the laser for treating glaucoma. That is, in various embodiments, the laser system 100 may not have a separate illumination member 104 in its probe member 102. Instead, the probe member 102 can have a single optical fiber core (e.g., the optical fiber core 534) through which both the excimer laser and the visible light for illuminating the treatment area inside the eye can pass. The visible light and the excimer laser can pass through the optical fiber core 534 without interfering with each other due to their different wavelengths, or the degree of interference can be small enough that the excimer laser for eye treatment is not affected. In this way, both the excimer laser and the visible light can pass through the single optical fiber core 534.

[0238] In addition to reducing the cost of the probe and the optical fiber therein by having one optical fiber instead of two, the connector 502 (slender cord) attached to the probe can be more easily maneuvered with only one optical fiber instead of two inside. Such a configuration can make the connector 502 (slender cord) less rigid and can reduce the diameter, weight, etc. of the connector 502. In addition, the visible light output at the delivery tip 502 of the probe 500 can be even closer to the location where the laser is applied for laser trabeculostomy treatment. In this way, the light emitted by the single optical fiber core 534 through which both the excimer laser and the visible light pass can more effectively irradiate the treatment area inside the eye. The protective sleeve or metal sleeve 532 can also surround Figure 25 the optical fiber core 534 therein. In some examples, the protective sleeve 532 is a protective plastic or rubber sheath. The protective sleeve or metal sleeve 538 can surround Figure 26 the optical fiber core 534 therein. In various embodiments, the protective sleeve or metal sleeve 532 can be a stainless steel sleeve and can surround and protect the optical fiber core 534. As shown, in various embodiments, the protective sleeve or metal sleeve 532 is coaxially aligned with the optical fiber core 534. In this way, the protective sleeve or metal sleeve 532 is adjacent to the optical fiber core 534.

[0239] In various embodiments, different types of light can be used. For example, visible white light can be used to illuminate the angled structure of the trabecular meshwork to obtain better visibility while approaching the trabecular meshwork with the fiber optic probe before the fiber optic probe contacts the tissue of the trabecular meshwork. When the probe contacts tissue (such as the trabecular meshwork), the visible white light can also illuminate the structure in front of the delivery tip of the fiber optic probe. In various embodiments, in addition to or as an alternative to visible white light, visible light of a specific wavelength can be used. For example, light of a wavelength highly absorbed by blood can be used so that the operator may be able to more easily identify and / or visualize the scleral venous sinus and other blood vessels present in the eye. Similarly, light of a wavelength not highly absorbed by blood clots can be used to visualize blood structures (e.g., a negative image of what would be shown with light highly absorbed by blood). Such wavelengths can provide the operator with better visibility of the structures of the eye, including blood vessels and other structures not on the surface of parts of the eye.

[0240] The laser probe can be applicable to intraocular surgeries where laser treatment of target tissue is desired. In particular, the laser probe can be used to treat glaucoma and to perform laser trabeculostomy. However, it should be noted that the laser probe consistent with the present disclosure can be used for any laser treatment of eye diseases, including but not limited to diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, cases of age-related macular degeneration, retinal tears, and retinopathy of prematurity, and laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism.

[0241] During laser trabeculostomy, it is crucial that the surgeon has a clear view inside the eye, particularly at the anterior chamber angle where the cornea and iris meet, such that the position of the laser relative to the trabecular meshwork can be clearly visualized. By using a laser probe, the surgeon can guide the delivery tip of the optical fiber core of the laser probe through the corneal incision of the eye and towards the trabecular meshwork. A light emitting member emits a visible light signal inside the eye and near the delivery tip, thereby illuminating the field of view in which the surgeon can visualize the positioning of the delivery tip and subsequently the transmission of laser energy onto the trabecular meshwork with the aid of a gonioscope. By providing a laser probe with an integrated illumination member, illumination is provided internally (i.e., inside the eye), which is contrary to current procedures that rely on external light sources, and thus provides a more comprehensive view inside the eye and an improved view of the target location. By providing an improved view, the surgeon is able to better position the delivery tip relative to the trabecular meshwork in order to achieve optimal photoablation and channel formation in the meshwork and / or the sinus venosus sclerae. In particular, when attempting to create optimal channel formation in the tissue, especially when attempting to achieve the placement of the channel relative to the sinus venosus sclerae in the meshwork, the orientation and positioning of the delivery tip are critical, which will provide optimal drainage. In addition, the surgeon is able to more confidently visually verify the effectiveness of the laser treatment by visualizing the drainage of aqueous humor as a result of the laser treatment.

[0242] Discrimination system and method for an excimer laser system

[0243] In the medical industry, there are many surgical devices, instruments, and systems that consist of separate components that must work properly together to ensure safe and intended treatment. For example, medical laser systems are used to treat various conditions in a variety of practice areas (i.e., urology, neurology, otolaryngology, general anesthesia ophthalmology, dentistry, gastroenterology, cardiology, gynecology, and thoracic and orthopedic surgery). A medical laser system consists of a laser unit that generates laser radiation and a separate laser probe that has an optical fiber adapted to guide the laser radiation from the laser through the optical fiber and to the treatment area.

[0244] Specific components of a laser system can be designed by a manufacturer to be used with other specific components. For example, there are various medical fibers available on the market that can be used with a laser system. Currently available laser systems can provide lasers of various wavelengths and can therefore be used for specific purposes and procedures. Accordingly, the fibers used with these laser systems can have different sizes (diameter, length, etc.), be made of various materials, operate at various temperatures, operate at various wavelengths, and have physical characteristics (e.g., bend radius). Specific components of a laser system can be designed by a manufacturer to be used with other specific components. For example, many types of medical fibers are available on the market that can be used with a laser system used in a medical procedure. Additionally, the manufacturer of one component can also manufacture other components of the laser system or can certify that these other components can be used with the manufacturer's own components.

[0245] Prior to commencing a medical procedure, it is important to connect an appropriate fiber to the laser unit to be used for the medical procedure. Typically, the manufacturer of the laser unit recommends using a specific brand of fiber and / or a specific fiber with the laser unit. When one of the components being used is not a certified product, the full capabilities of the system may not be achieved and further may result in malfunctions that endanger patient safety. For example, using an inappropriate fiber may result in damage to the equipment, delay of the medical procedure until an appropriate fiber is obtained, and / or the possibility of an ineffective, damaging, or potentially life-threatening medical procedure.

[0246] Various embodiments provide a system for certifying a laser probe for use with a laser system. In such a system, the elements typically include a laser unit and a single-use disposable laser probe to be coupled to the laser unit, each laser probe having an optical fiber adapted to direct laser radiation from the laser unit through the fiber to a treatment area. The laser unit includes a control system for operating the laser unit, including controlling the output of laser radiation to the laser probe coupled to the laser unit. The laser unit also includes (a) structure configured to authenticate any given laser probe to determine whether the laser probe is suitable 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 when the laser probe is attached to the laser unit. The data from the RFID tag is analyzed by the control system and it is determined whether the laser probe is certified (i.e., suitable for use with the laser unit). In the event that the laser probe is determined to be certified, the control system allows transmission of laser radiation to the laser probe and thus the laser probe can be used to perform a surgery. In the event that the laser probe is determined to be uncertified, the control system blocks transmission of laser radiation to the laser probe.

[0247] The authentication analysis is based on the correlation of RFID tag data with known predefined authentication data stored in a database that is local to the laser unit or stored in a remote database. The known predefined authentication data is controlled by the owner / manufacturer of the laser unit such that the owner / manufacturer can determine which laser probes will be used with the laser unit. The owner / manufacturer can set specific authentication keys or provide specific identification numbers proprietary to the owner / manufacturer. Thus, the RFID tag data of any given laser probe must include the corresponding unique identifier (i.e., authentication key or identification number) in order to be considered authenticated. The RFID tag data can include other information and / or characteristics associated with the laser probe and the optical fiber. For example, in some embodiments, the RFID tag data also includes operation history information of the laser probe. Thus, in some embodiments, the control system can also be utilized to de-authenticate the laser probe based on the operation history, such as in the case where the probe has been used and / or reached the recommended maximum number of laser pulses, thereby preventing further use of the laser probe with the laser unit.

[0248] Thus, the authentication systems of the various embodiments ensure that only authorized laser probes can be used with the laser unit. Authentication ensures that only those laser probes recommended and certified by the manufacturer are used, thus ensuring that the laser system functions as intended and maintaining patient safety. Authentication further prevents the use of counterfeit components. As counterfeit proprietary components become more prevalent, the need to authenticate original products becomes increasingly necessary. By directly embedding RFID in the laser probe and utilizing RFID technology for authentication, the manufacturer can safeguard against counterfeit products and ensure recurring revenue streams that might otherwise be lost due to counterfeit products.

[0249] Various embodiments provide a system for authenticating a laser probe for use with a laser system. In such systems, the components typically include a laser unit and a single-use disposable laser probe to be coupled to the laser unit, each laser probe having an optical fiber adapted to direct laser radiation from the laser unit through the optical fiber to a treatment area. The laser unit includes a control system for operating the laser unit, including controlling the output of laser radiation to the laser probe coupled to the laser unit. The laser unit also includes (a) structure(s) configured to authenticate any given laser probe to determine whether the laser probe is suitable 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 when the laser probe is attached to the laser unit. The data from the RFID tag is analyzed by the control system, and it is determined whether the laser probe has been authenticated (i.e., is suitable for use with the laser unit). In the case where the laser probe is determined to be authenticated, the control system allows the transmission of laser radiation to the laser probe, and thus the laser probe can be used to perform a surgical procedure. In the case where the laser probe is determined not to be authenticated, the control system blocks the transmission of laser radiation to the laser probe.

[0250] Accordingly, the authentication system of various embodiments ensures that only authenticated laser probes can be used with the laser unit. Authentication ensures that only those laser probes recommended and authorized by the manufacturer are used, thereby ensuring that the laser system functions as intended and maintaining patient safety. Authentication further prevents the use of counterfeit components. As counterfeit proprietary components become more prevalent, the need to authenticate original products becomes increasingly necessary. By directly embedding RFID in the laser probe and using RFID technology for authentication, the manufacturer can thwart counterfeiters and ensure recurring revenue streams that might otherwise be lost due to counterfeit products.

[0251] The laser unit and laser probe of various embodiments can be applicable to intraocular surgeries where laser treatment of a target tissue is desired. In particular, the laser probe and laser unit of various embodiments can be used to treat glaucoma and can be used to perform laser trabeculostomy. However, it should be noted that the laser probe consistent with the present disclosure can be used for any laser treatment of various conditions, including other eye diseases (i.e., diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, age-related macular degeneration, retinal tears, and cases of retinopathy of prematurity), as well as laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism, and other conditions in general and other practice areas (non-ocular practice areas).

[0252] Figure 27A excimer laser system is shown, 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 "control system 4104"), and a laser source 4106. The laser probe 4200 includes an RFID tag 4202 and an optical fiber core 4204. As will be described in more detail herein, many components of the laser unit system 4100 may be contained within a housing, such as a movable platform, to provide an environment (e.g., an operating room, a procedure room, an outpatient environment, etc.) in which a surgery is to be performed, and the probe 4200 may be connected to the housing for use during treatment. When the probe 4200 is coupled to the housing, the optical fiber core 4204 is coupled to the laser source 4106 and is adapted to direct laser radiation from the laser source 4106, through the optical fiber, and to a treatment area.

[0253] The laser source 4106 may include an excimer laser 4108 and a gas cylinder 4110 for providing an appropriate gas mixture to the laser 4106. The excimer laser 4106 is in the form of an ultraviolet laser, which typically operates in the UV spectral region and produces nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cylinder 4110) is typically a gas mixture containing an inert gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high voltage, a pseudomolecule called an excimer (or an exciplex in the case of an inert gas halide) is produced, which can only exist in an excited state and can produce laser light in the UV range.

[0254] Laser action occurs in the excimer molecule because it has a bound (associated) excited state but a repulsive (dissociative) ground state. Noble gases such as xenon and krypton are highly inert and generally do not form chemical compounds. However, when in an excited state (induced by a discharge or a high-energy electron beam), they can form temporarily bound molecules with themselves (excimers) or with halogens (exciplexes) such as fluorine and chlorine. The excited compound can release its excess energy by undergoing spontaneous or stimulated emission, thereby producing a strongly repulsive ground state molecule, which dissociates back into two unbound atoms very rapidly (on the picosecond timescale). This forms a population inversion. The excimer laser 4108 of the present system 4100 is a XeCl excimer laser and emits a wavelength of 308 nm.

[0255] The controller 4104 provides the operator (i.e., the surgeon or other medical professional) with control over the output of the laser signal (from the laser source 4106 to the optical fiber core 4204), and thereby controls the transmission of laser energy from the optical 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 process to determine whether the laser probe 4200 is actually suitable for use with the laser unit system 100. In particular, when the laser probe 4200 is coupled to the system 4100, the RFID reader 4102 reads the data embedded in the RFID tag 4202 of the laser probe 4200, and this RFID tag data is analyzed to determine that the laser probe 4200 has been authenticated.

[0256] Figure 28 The authentication of the laser system 4100 and the laser probe 4200 used with the laser system 4100 is shown. The data from the RFID tag is read by the RFID reader and then analyzed by the controller 4104. Based on the authentication analysis, it is determined whether the laser probe has been authenticated (i.e., suitable for use with the laser unit). In the case where the laser probe is determined to be authenticated, the controller 104 allows the transmission of laser radiation to the laser probe 4200, and thus the laser probe 4200 can be used to perform surgery. In the case where the laser probe is determined not to be authenticated, the controller 4104 prevents the transmission of laser radiation to the laser probe 4200.

[0257] The controller 4104 can include software, firmware, and / or circuitry configured to be able to perform any of the foregoing operations. The software can be embodied as a software package, code, instructions, instruction set, and / or data recorded on a non-volatile computer-readable storage medium. The firmware can be embodied as code, instructions, or instruction set and / or data hard-coded (e.g., non-volatile) in a memory device. As used in any embodiment herein, "circuitry" can include, for example, 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 storing instructions executed by the programmable circuitry. For example, the controller 4104 can include a hardware processor coupled to a non-volatile computer-readable memory that contains instructions executable by the processor to cause the controller to perform various functions of the laser system 4100 as described herein, including controlling the laser and / or illumination output.

[0258] Authentication analysis is performed based on the correlation of RFID tag data with known predefined authentication data stored in a database, which is either a local database (i.e., the probe database 4114) that forms part of the laser unit system 4100 or a remote database (i.e., the probe database 4302) hosted via a remote server 4300. For example, in some embodiments, the system 4100 can communicate and exchange data with the remote server 4300 via 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 collection of such computer networks, such as an intranet, an extranet, or the Internet (i.e., the global system of interconnected networks on which various applications or services run, including, for example, the World Wide Web).

[0259] The known predefined authentication data stored in the database (either database 4114 or database 4302) can be controlled by the owner / manufacturer of the laser unit 4100. For example, the owner / manufacturer can determine what laser probes will be used with the laser unit. For example, the owner / manufacturer can set a specific authentication key or provide a specific identification number proprietary to the owner / manufacturer. Thus, the RFID tag data of any given laser probe must include the corresponding unique identifier (i.e., the authentication key or identification number) in order to be considered authenticated.

[0260] One way to uniquely identify a laser probe is to authenticate the probe using a privacy key. In this method, both the laser system 4100 and the RFID tag 4202 are taught the same key. The RFID tag 4202 and the laser system 4100 then cooperate to authenticate the key. More specifically, the laser system 4100 generates a random unique challenge number. The RFID tag 4202 uses the challenge in combination with the key to generate a response for the authentication code. The method used to generate the code (called a hash function) masks the value of the key. Another way to uniquely identify a laser probe is to use a unique and immutable identification number. This method can be used if there is a memory area (e.g., a serial number or model number) that can only be written by the RFID manufacturer. Protection is achieved by ensuring that the manufacturer only provides tags with legitimate identification numbers, preventing the simple replication of legitimate tags.

[0261] RFID tag data may include other information and / or characteristics associated with the laser probe and the optical fiber. For example, in some embodiments, the RFID tag data further includes operational history information of the laser probe. Thus, in some embodiments, the controller 4104 may also be utilized to de-authenticate the laser probe based on the operational history, e.g., in the case where the probe has been used and / or reached the recommended maximum number of laser pulses, thereby preventing further use of the laser probe with the laser unit.

[0262] As is generally understood, RFID technology uses electromagnetic fields to automatically identify and track tags attached to objects. As previously mentioned, the RFID tag associated with the laser probe contains electronically stored information. The RFID tag can be read-only, with a factory-assigned serial number that serves as a key in a database, or it can be read / write, where object-specific data can be written to the tag by the system user. A field-programmable tag can be write-once, read-many; a "blank" tag can be written with an electronic product code by the user. The RFID tag includes 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 the incident reader signal; and an antenna for receiving and transmitting signals. The tag information is stored in non-volatile memory. The RFID tag includes fixed logic or programmable logic for processing transmission and sensor data, respectively.

[0263] The RFID reader sends an encoded radio signal to interrogate the tag. The RFID tag receives the message and then responds with its identification and other information. This can be just the unique tag serial number, or it can be product-related information such as inventory number, lot or batch number, production date, or other specific information. Since the tags have individual serial numbers, the RFID system design can distinguish several tags that may be within the range of the RFID reader and read them simultaneously.

[0264] In some embodiments, the RFID tag can be a passive tag that harvests energy from the RFID reader of the laser system that interrogates the radio wave. In some embodiments, the RFID tag can be an active tag that includes a local power source (e.g., a battery) and can operate hundreds of meters away from the RFID reader of the laser system. Figure 4 An example excimer laser unit that can be used according to various embodiments is shown. The RFID reader 4102, the controller 4104, and the laser source 4106 can be included within the housing 402. It should also be noted that the RFID reader 4102 can be located near the connection port 406 to allow reading of data from the RFID tag 4202 disposed on the connection end of the laser probe 4200.

[0265] Figure 29shows an embodiment of a probe 500 similar to Figure 6 except that the connection assembly may additionally have an RFID tag embedded therein or attached thereto. For example, an RFID tag 4202 is disposed on the connection assembly 504 such that when the connection assembly 504 is coupled to the connection port 406 of the laser unit system 100, the RFID reader 4102 can read the data embedded in the RFID tag 4202.

[0266] Figure 30 and Figure 31 show cross-sectional views of the probe 500 taken along lines A-A and B-B of Figure 29 respectively. As shown, the optical fiber core 518 extends through the probe 500 and forms part of the connector 502. The protective sheath 516 surrounds the optical fiber core 518. In some examples, the protective sheath 516 is a protective plastic or rubber sheath. The optical fiber core 518 further forms part of the delivery tip 506 of the probe 500. The metal sheath 520 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, a stainless steel sheath 520 surrounds and protects the optical fiber core 518.

[0267] Figure 32 shows an embodiment of a laser probe 500 attached to the laser unit system 100. As previously described, when the laser probe 500 is attached to the system 100 (i.e., the coupling between the connection assembly 504 of the probe 500 and the connection port 406 of the system 400), the RFID reader 4102 reads the data embedded in the RFID tag associated with the connection assembly 504. Figure 33 shows an enlarged view of the connection between the laser probe 500 and the system 4100 and the initial RFID read for determining the authenticity of the laser probe 4200. The data from the RFID tag is analyzed by the controller 4104, and it is determined whether the laser probe is authenticated (i.e., suitable for use with the laser unit). In the case where the laser probe 4200 is determined to be authenticated, the controller allows the transmission of laser radiation to the laser probe 4200. In the case where the laser probe 4200 is determined not to be authenticated, the controller 4104 prevents the transmission of laser radiation to the laser probe.

[0268] Thus, the authentication systems of the various embodiments can ensure that only authenticated laser probes can be used with the laser unit. Authentication ensures that only those laser probes recommended and authorized by the manufacturer are used, thus ensuring that the laser system functions as expected and maintaining patient safety. Authentication further prevents the use of counterfeit components. As counterfeit proprietary components become more prevalent, the need to authenticate the original products becomes increasingly necessary. By directly embedding RFID in the laser probe and using RFID technology for authentication, the manufacturer can thwart counterfeiters and ensure recurring revenue streams that might otherwise be lost due to counterfeit products.

[0269] Figure 34 and 35 shows a further example of how to verify the use of a probe with an excimer laser unit for ELT treatment. Figure 34 is a flowchart of an embodiment for verifying a probe for use with an excimer laser unit. Figure 35 is a flowchart of an embodiment for preventing the use of an unauthenticated probe.

[0270] At 3402, the probe can be connected to the ELT machine. The probe can have an RFID tag or other readable sensor or memory. The memory can include data for authenticating the probe. At 3404, the authentication data stored on the probe can be read, for example, by a reader on the ELT machine. At 3406, it can be determined, for example, by the processor of the ELT machine that the authentication data is valid. In various embodiments, if the ELT machine is connected to a network of other computing devices, the processor of another device (e.g., a remote server) can be used to determine that the authentication data is valid. The authentication data can be encrypted or otherwise encoded such that the authentication data can be decoded or decrypted before its validity is determined. The data stored on the probe can further indicate other information beyond its mere validity or invalidity. For example, the data on the probe can indicate the country, city, or place of origin (e.g., where the probe was manufactured), the type of the probe, the brand or trade name of the probe, the type of materials used in the probe, the identity of the purchaser of the probe, the identity of the manufacturer of the probe, etc. Thus, the ELT machine (using its own processor or through another computing device) can determine various information about the probe stored on the probe. In various embodiments, the probe can determine the availability of the probe based on a look-up table or other database of probe information. For example, the look-up table or database can include information about available probes, unavailable probes, etc. If the authentication data matches the data stored in the look-up table or the database associated with the available probes, the probe can be considered available. The look-up table can be stored in the memory of the ELT machine or in the memory of another computing device connected to the ELT machine via a network.

[0271] If the probe is authenticated at 3406, the probe can be used for ELT processing at 3408. The probe can also be used based on additional data stored on the probe, or otherwise determined based on the data stored on the probe. For example, the data stored on the probe can indicate how much total energy should be allowed to pass through the probe without significant degradation, can indicate how much total emission the probe should be used for, what wavelength of energy the probe should use, and / or any other aspect of using the probe. In various embodiments, instead of storing the data on the probe, the ELT machine or another computing device can identify the probe as a certain type of probe based on the data stored on the probe. In such embodiments, the ELT machine or other computing device can then determine additional information about how the probe should be used (e.g., how much total energy, number of emissions, wavelength, etc.) based on the type of the attached probe. Such information can be further stored in a lookup table or database such that authentication can occur along with identifying other aspects of the probe, even if those aspects are not specifically stored on the probe itself. Such lookup table or database can be further updated over time with information about new probes being manufactured such that the ELT machine can correctly determine whether the probe is available. Such updates can occur over a network such as the Internet.

[0272] At 3410, the authentication data on the probe is changed (e.g., the data stored on the probe's memory is erased, changed, rewritten, added, etc.) such that the authentication data is no longer valid. In other words, the data on the probe can be modified in some way such that if the probe is reconnected to the ELT machine or another ELT machine, the ELT machine will determine that the probe is not available and will not allow the use of the probe. In this way, probes that are not manufactured by a trusted manufacturer, probes that have been used, probes that have been tampered with, etc. cannot be used. Similarly, if the ELT machine does not find data on the probe (e.g., the probe does not have an RFID tag, memory, etc.), the ELT machine can determine that the probe is not available and prevent the use of such probes. Such methods protect the patient because counterfeit probes may not be manufactured correctly and may cause accidents that damage the patient's eyes. Similarly, probes that have been used may also be unavailable or dangerous for use on a patient because the optical fibers in the probe may degrade after use.

[0273] Although reference is made to Figure 34The described embodiments relate to probes having memory that can be modified by an ELT machine, but other embodiments of validating probes are further envisioned herein. For example, the memory of a probe or RFID tag can have static code or data stored thereon. The ELT machine can read the data from the probe and check a database or look-up table to determine whether the particular probe has been used before, and / or to determine whether the data on the probe is available. If the data is available, but the look-up 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 has been used, the processor of the ELT machine or another computing device can update the look-up table or database to indicate that the particular probe associated with the data read from the probe has been used. Then, if the ELT machine or another ELT machine reads data from the probe again, it can be determined from the look-up table or database that the probe has been used, and the probe will not be allowed to be used with the ELT machine.

[0274] Figure 35 Method 3500 is described, in which a probe is determined to be unavailable. At 3502, it is determined that the unavailable probe is connected to an ELT machine (e.g., based on data stored on the probe). At 3504, the ELT machine or a computing device associated with the ELT machine displays that the probe is unavailable on an interface. Thus, the probe can not be used with the ELT machine. In various embodiments, method 3500 can end after 3504.

[0275] In other embodiments, at 3506, it can be determined that a predetermined threshold number of unavailable probes have been attempted to be used with the ELT machine. In other words, if a particular number of unavailable probes have been attempted to be used, the machine can determine that a particular threshold has been met or exceeded. For example, the threshold can be set by the manufacturer of the ELT machine. After determining that the threshold has been exceeded, the interface can display at 3508 that the ELT machine is disabled, inoperable, or otherwise taken out of service. Optionally, other information can be displayed, such as indicating to the operator to obtain service for the ELT machine, indicating that the operator must have the machine reset by a representative of the manufacturer due to too many unavailable probe uses, etc. In various embodiments, for example when the ELT machine is connected to a network, an alert or message can also be sent to a computing device controlled or associated with a party other than the manufacturer of the ELT machine or the operator of the ELT machine, such that the manufacturer or other party can be warned of the attempt to use an unavailable probe. The alert or message can be sent similarly only when a predetermined threshold of attempting to use an unavailable probe is reached, which can be the same or different threshold as the threshold that triggers the disabling of the ELT machine. At 3510, the ELT machine itself can be disabled based on the threshold being met or exceeded. In this way, patients can be protected from operators who repeatedly attempt to use invalid probes for eye surgery.

[0276] As used in any embodiment herein, the term "module" can refer to software, firmware, and / or circuitry configured to perform any of the foregoing operations. The software can be embodied as a software package, code, instructions, instruction set, and / or data recorded on a non-transitory computer-readable storage medium. The firmware can be embodied as code, instructions, or instruction set and / or data hard-coded (e.g., non-transitory) in a memory device. As used in any embodiment herein, "circuitry" can 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 the programmable circuitry, either individually or in any combination. A module can be embodied, jointly or separately, as circuitry that forms 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 smart phone, etc.

[0277] Any operation described herein can be implemented in a system including one or more storage media having instructions stored thereon, either individually or in combination, that, when executed by one or more processors, perform the method. Here, the processor can include, for example, a server CPU, a mobile device CPU, and / or other programmable circuitry.

[0278] In addition, it is intended that the operations described herein can be distributed across multiple physical devices, such as processing structures at more than one different physical location. The storage media can include any type of tangible medium, e.g., any type of disk, including hard disks, floppy disks, optical disks, compact disc read-only memory (CD-ROM), rewritable compact disc (CD-RW), and magneto-optical disks, semiconductor devices (such as read-only memory (ROM)), random access memory (RAM) (such as dynamic and static RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid state disk (SSD), magnetic or optical cards, or any type of medium suitable for storing electronic instructions. Other embodiments can be implemented as software modules executed by a programmable control device. The storage media can be non-transitory.

[0279] As described herein, various embodiments can be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements can include processors, microprocessors, circuitry, 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, chip sets, etc.

[0280] References to "an embodiment" or "embodiments" in the present specification mean that the particular features, structures, or characteristics described in connection with the embodiment are included in at least one embodiment. Thus, the phrases "in an embodiment" or "in embodiments" that appear in various places throughout the present specification do not necessarily all refer to the same embodiment. In addition, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0281] The term "non-volatile" should be understood to remove only the propagation of non-volatile signals themselves from the scope of the claims, and not to disclaim the right to all standard computer-readable media that not only propagate volatile signals themselves. In other words, the meaning of the terms "non-volatile computer-readable medium" and "non-volatile computer-readable storage medium" should be construed to exclude only those types of volatile computer-readable media found in In Re Nuijten that are outside the scope of patentable subject matter under 35 U.S.C. § 101.

[0282] The terms and expressions that have been employed herein are used as terms of description and not of limitation, and in using these terms and expressions, there is no intention to exclude any equivalents of the features (or portions thereof) shown and described, and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0283] Calibration System for Improving the Manufacturing Tolerance of Excimer Laser Fibers

[0284] In the medical industry, there are many surgical devices, instruments, and systems that consist of individual components that must work properly together to ensure the safe and effective performance of a treatment. Critically, any given component falls within an acceptable tolerance to ensure that the component physically mates and interacts properly with other components and functions as intended.

[0285] The actual production of any product (or the operation of any system) involves some inherent variations in inputs and outputs. Measurement errors and statistical uncertainties also exist in all measurements. Thus, tolerance is an inherent aspect in designing a device, instrument, or system. The concept of tolerance (sometimes referred to as engineering tolerance) involves one or more allowable limits of variation in the physical dimensions of a component, the measured values or physical properties of a component, the spacing between a component and another component, etc. Thus, if a component falls outside the allowable tolerance (i.e., the component is too small, too large, does not have acceptable properties, etc.), then the entire device, instrument, or system will not perform as designed.

[0286] An example of a surgical system consisting of multiple components is a medical laser system. A medical laser system typically consists of a laser unit and a separate laser probe having an optical fiber for guiding laser radiation from the laser unit to the treatment area. The laser unit provides laser light of a specific wavelength and can thus be designed to perform specific procedures. For example, certain procedures may require photocoagulation of the target tissue, which occurs when delivering laser radiation of a first wavelength, while other procedures may require photoablation of the target tissue, which occurs when delivering laser radiation of a second wavelength. In turn, the optical fibers used with these laser systems can have specific dimensions, material compositions, and / or functional characteristics (i.e., operate at specific temperatures and wavelengths) in order to function as expected with the corresponding laser unit.

[0287] While current laser units allow for some tolerances (i.e., the fiber optic size, properties, or conditions can have some variation without significantly affecting the function of the laser system), the range of allowable tolerances is very strict. For example, the optical fiber has a very small diameter, which is typically measured on the micron scale. The diameter of the optical fiber can affect the transmission of laser radiation through the fiber and can thus affect the laser radiation emitted from the delivery tip of the fiber. Therefore, there is very little room for variation in the manufacture of the optical fiber. Due to the high precision required to ensure that the diameter of the optical fiber falls within the allowable tolerances, the manufacturing cost increases. In addition, if a given optical fiber falls outside the allowable tolerances (i.e., the diameter is too large or too small), the use of a non-compliant optical fiber may result in the transmission of laser radiation at an unexpected wavelength. In turn, the use of a non-compliant optical fiber poses a risk of providing an ineffective treatment and, in some cases, may result in additional accidental damage and injury.

[0288] Various embodiments provide a system for calibrating the output from a laser source to compensate for increased variations in a laser optical fiber. In such systems, the components typically include a laser source for generating laser energy to be provided to one of a plurality of laser probes that can be coupled thereto. Each laser probe includes an optical fiber that includes a fiber core and is adapted to guide laser radiation from the laser source through the fiber to a desired treatment area. The system also includes a laser management system for managing the laser source. The management system includes a control system configured to adjust the laser energy output from the laser source to any given laser probe to maintain a consistent level of laser radiation delivered to the target area, regardless of variations in the fiber core of any given laser probe.

[0289] More specifically, as part of an initial setup, the control system receives data associated with a laser probe coupled to a laser source. The data can include one or more dimensions of the optical fiber core of the laser probe, including the fiber core diameter. The data is then analyzed by a controller, and based on the analysis, the optimal level of laser energy output from the laser source is determined. The optimal level of laser energy output from the laser source is based on the correlation of the laser probe data (such as a specific dimension of the fiber core) with calibration data. The calibration data can generally include multiple sets of values, where each set of values can include the laser energy output level from the laser source, the diameter of the fiber core of the laser probe for receiving the laser energy output level, and the resulting wavelength value of the laser radiation emitted from the delivery tip of the laser probe. The resulting wavelength value of the laser radiation to be emitted from the delivery tip can remain constant regardless of the diameter of the fiber core. In such embodiments, the laser management system (i.e., the control system) automatically adjusts the laser energy output level from the laser source (i.e., increases or decreases the output level) for any given diameter of the fiber core so as to maintain the laser radiation being emitted at a consistent wavelength over the target area, regardless of variations in the diameter of the fiber cores from multiple laser probes.

[0290] Thus, the systems of various embodiments can be capable of compensating for a wide range of variations across multiple laser probes by simply adjusting the output of the laser source to account for such variations. In turn, the manufacturing tolerances of the optical fibers are improved because lower precision is required during the manufacturing process, which reduces the overall cost. Additionally, by fine-tuning the laser output, the laser radiation remains at a consistent wavelength, ensuring that the target area is treated as intended and maintaining patient safety.

[0291] Various embodiments provide a system for calibrating the output from a laser source to compensate for increased variations in a laser optical fiber. In such a system, the components generally include a laser source for generating laser energy to be provided to one of a plurality of laser probes that can be coupled thereto. Each laser probe includes an optical fiber that includes an optical fiber core, and the optical fiber is adapted to direct laser radiation from the laser source through the optical fiber to a desired treatment area. The system also includes a laser management system for managing the laser source. The management system includes a control system that is configured to adjust the laser energy output from the laser source to any given laser probe to maintain a consistent level of laser radiation delivered to the target area, regardless of variations in the optical fiber core of any given laser probe.

[0292] Thus, the systems of various embodiments can be capable of compensating for a wide range of variations across multiple laser probes by simply adjusting the output of the laser source to account for such variations. In turn, the manufacturing tolerances of the optical fibers are improved because lower precision is required during the manufacturing process, which reduces the overall cost. Additionally, by fine-tuning the laser output, the laser radiation remains at a consistent wavelength, ensuring that the target area is treated as intended and maintaining patient safety.

[0293] The systems of the various embodiments can be applicable to intraocular surgeries where laser treatment of a target tissue is desired. Specifically, the laser sources, laser management systems, and laser probes of the various embodiments can be used to treat glaucoma and can be used to perform laser trabeculostomy. However, it should be noted that the systems in accordance with the present disclosure can be used for any laser treatment of various conditions, including other eye diseases (i.e., diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, cases of age-related macular degeneration, retinal tears, and retinopathy of prematurity), as well as laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism, and other conditions in general and other practice areas (non-ocular practice areas).

[0294] Figure 36 An excimer laser system is shown, 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 an optical fiber core 5204. As will be described in more detail herein, many components of the laser unit system 5100 can be contained in a housing, such as a movable platform, to provide in an environment where the surgery is to be performed (e.g., an operating room, a procedure room, an outpatient environment, etc.), and the probe 5200 can be connected to the housing for use during treatment. When the probe 5200 is coupled to the housing, the optical fiber core 5202 is coupled to the laser source 5102 and is adapted to direct laser radiation from the laser source 5102 through the optical fiber and to the treatment area.

[0295] The laser source 5102 includes an excimer laser 5104 and a gas cylinder 5106 for providing an appropriate gas mixture to the laser 5104. The excimer laser 5104 is in the form of an ultraviolet laser, which typically operates in the UV spectral region and produces nanosecond pulses. The excimer gain medium (i.e., the medium contained within the gas cylinder 5106) is typically a gas mixture containing an inert gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high voltage, a pseudomolecule called an excimer (or an exciplex in the case of an inert gas halide) is produced, which can only exist in an energized state and can produce laser light in the UV range.

[0296] Laser action occurs in excimers because they have a bound (associated) excited state but a repulsive (dissociative) ground state. Noble gases such as xenon and krypton are highly inert and generally do not form chemical compounds. However, when in an excited state (induced by a discharge or a high-energy electron beam), they can form transiently bound molecules with themselves (excimers) or with halogens such as fluorine and chlorine (exciplexes). The excited compound can release its excess energy by undergoing spontaneous or stimulated emission, resulting in a strongly repulsive ground-state molecule that dissociates very rapidly (on the picosecond timescale) back into two unbound atoms. This creates a population inversion. The excimer laser 5104 of the present system 5100 is a XeCl excimer laser and emits at a wavelength of 308 nm.

[0297] The laser management system 5108 manages the laser source 5102. In particular, as Figure 37 shown, the laser management system 5108 includes a controller 5110 (also referred to herein as "control system 5110"). The controller 5110 provides the operator (i.e., the surgeon or other medical professional) with control over the output of the laser signal (from the laser source 5102 to the fiber core 5202), and in turn controls the transmission 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 to maintain a consistent level of laser radiation transmitted from the probe 5200 to the target area, despite any variations in the fiber core 5202 of the probe 5200.

[0298] Figure 37 The calibration of the laser output of the laser unit system 5100 and the laser probe 5200 used with the system 5100 is shown to account for variations in the fiber core of the laser probe 5200. Figure 38 The process of calibrating the laser output is shown, including adjusting the laser energy output from the laser source to the laser probe to account for variations in the fiber core 5202 of the laser probe 5200.

[0299] As part of the initial setup, the controller 5110 receives data associated with a laser probe coupled to the laser source 5102. In this case, data from the laser probe 200 is provided to the controller 5110. The data can be input manually (via a user interface provided on the system 5100), or can be automatically read from a readable device or label on the probe 200 via an associated reader of the system 5100. The data can 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 characteristics of the optical fiber core 5202, and the physical dimensions and / or measurements or physical characteristics of other components of the probe 5200. In one embodiment, the data includes the diameter of the optical fiber core 5202.

[0300] The data is then analyzed by the controller 5110, and based on the analysis, the optimal level of laser energy output from the laser source 5102 is determined. The analysis is based on the correlation between the laser probe data (such as the specific dimensions of the optical fiber core) and the calibration data. The calibration data is stored in a database, either a local database (i.e., the calibration database 5112) that is part of the laser unit system 5100, or a remote database (i.e., the calibration database 5302) hosted via a remote server 5300. For example, in some embodiments, the system 5100 can communicate and exchange data with the remote server 5300 via 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 collection of such computer networks, such as an intranet, an extranet, or the Internet (i.e., the global system of interconnected networks on which various applications or services run, including, for example, the World Wide Web).

[0301] The calibration data generally can include multiple sets of values, where each set of values can include the laser energy output level from the laser source, the diameter of the optical fiber core of the laser probe for receiving the laser energy output level, and the resulting wavelength value of the laser radiation emitted from the transmission tip of the laser probe. The resulting wavelength value of the laser radiation emitted from the delivery tip can remain constant regardless of the diameter of the optical fiber core. In such embodiments, the laser management system (i.e., the control system) automatically adjusts the laser energy output level from the laser source (i.e., increases or decreases the output level) for any given diameter of the optical fiber core so as to maintain the laser radiation being emitted at a consistent wavelength onto the target area, regardless of variations in the diameters of the optical fiber cores from multiple laser probes.

[0302] The controller 5110 may include software, firmware, and / or circuitry configured to perform any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction set, and / or data recorded on a non-volatile computer-readable storage medium. The firmware may be embodied as code, instructions, or instruction set and / or data hard-coded (e.g., non-volatile) in a memory device. As used in any of the embodiments 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 the programmable circuitry, either individually or in any combination. For example, the controller 5104 may include a hardware processor coupled to a non-volatile computer-readable memory that contains instructions executable by the processor to cause the controller to perform various functions of the laser system 5100 as 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 and at least in part identify a level of correlation, thereby correlating the data sets with each other based on the level of correlation.

[0303] Figure 4 The excimer laser unit 100 may be similar to the laser unit system 5100 and / or the laser source 5102 and may be used as (in whole or in part) the laser unit system 5100 and / or the laser source 5102. In various embodiments, the laser source 5102 (including the excimer laser 5104 and the gas cylinder 5106) and the laser management system 5108 (including the controller 5110) may be contained within the housing 402. The operator may 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 may be automatically read via an associated reader of the system 5100 from a readable device or code (e.g., optically and / or electronically readable) and / or label on the probe 5200.

[0304] Such as Figures 4 - 6 the probes shown in 21, 24, 29, and / or 32 may be used with the excimer laser system 5100. For example, Figure 39An embodiment of a laser probe 500 attached to a laser unit system 5100 is shown. As previously described, when attaching the laser probe 500 to the system 5100 (i.e., the coupling between the connection assembly 504 of the probe 500 and the connection port 406 of the system 400), the laser management system 5108 (including the controller 5110) performs a calibration process before using the probe 500. In particular, data associated with the characteristics of the probe 500, such as the diameter of the fiber optic core, is provided to the laser management system 5108. The data is then analyzed by the controller 5110, and based on the analysis, the optimal level of laser energy output from the laser source is determined. The optimal level of laser energy output from the laser source can be based on the correlation between laser probe data (such as a specific size of the fiber optic core) and calibration data. The controller 5110 automatically adjusts the laser energy output level from the laser source (i.e., increases or decreases the output level) for any given diameter of the fiber optic core in order to maintain the laser radiation being emitted at a consistent wavelength onto the target area, regardless of variations in the diameter of the fiber optic cores from multiple laser probes.

[0305] Accordingly, the systems of various embodiments are capable of compensating for a wide range of variations across multiple laser probes by simply adjusting the output of the laser source to account for such variations. In turn, the manufacturing tolerances of the optical fibers are improved because lower precision is required during the manufacturing process, reducing the overall cost. Additionally, by fine-tuning the laser output, the laser radiation remains at a consistent wavelength, ensuring that the target area is treated as expected and maintaining patient safety.

[0306] Combined Treatment Using ELT

[0307] In glaucoma, there is an accumulation of a fluid volume called aqueous humor in the anterior chamber of the eye. The fluid normally drains from the eye in an area called the trabecular meshwork and typically flows through the scleral venous sinus in the trabecular meshwork. However, when an individual has glaucoma, the fluid accumulation causes an increase in intraocular pressure (IOP). The increased pressure gradually causes damage to the optic nerve and results in irreversible vision loss.

[0308] Traditional methods of treating glaucoma manage the condition by reducing the IOP or producing less aqueous humor. Traditional glaucoma treatments include pharmaceutical treatments, laser treatments, surgical treatments, and combinations thereof. Pharmaceutical treatments do not provide a permanent solution but manage the condition by reducing the production of fluid or increasing the drainage of fluid to lower the IOP. Laser treatments are also used to lower the IOP by increasing fluid outflow or reducing fluid production. However, laser and pharmaceutical treatments typically do not effectively treat advanced glaucoma. Accordingly, individuals with glaucoma are also treated surgically, such as by inserting an implant into the eye to increase drainage. However, these surgeries are accompanied by risks, such as displacement of the implant.

[0309] Various embodiments provide methods for treating glaucoma using a combination of excimer laser trabeculostomy (ELT). The methods include performing ELT on a subject with glaucoma who has previously undergone a failed treatment. Since glaucoma is a progressive disease, previous treatments may become ineffective as the condition worsens. Thus, glaucoma patients often endure several failed treatments. The methods of the various embodiments provide glaucoma treatment using ELT and can be implemented even when previous treatment methods have failed. During the ELT procedure, the laser probe is positioned adjacent to the scleral venous sinus to form perforations in the trabecular meshwork and / or the scleral venous sinus to immediately improve fluid drainage. The perforations can also increase the outflow of aqueous humor and reduce the pressure in the eye.

[0310] In various examples, the failed treatment is a conventional method for treating glaucoma, such as prescription drugs or pharmaceutical therapy, laser therapy, surgical therapy, or a combination thereof. Generally, prescription drugs or pharmaceutical therapy are medicated eye drops, such as an α-agonist, β-blocker, carbonic anhydrase inhibitor, cholinergic agonist, prostaglandin / prostamide analog, or a combination thereof. Examples of laser therapy include trabeculoplasty, iridotomy, iridectomy, and combinations thereof. Examples of trabeculoplasty include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Surgery has traditionally been a last resort after medical and laser therapies due to the relatively high complication rate and the unpredictability of surgeries such as trabeculectomy. Examples of surgical therapy include the insertion of a shunt or implant, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscocanalostomy, or a combination thereof.

[0311] One example involves providing glaucoma treatment to a subject who has previously had a failed glaucoma treatment or has become ineffective. For example, pharmaceutical therapy may have previously effectively treated the subject's glaucoma until the disease progressed to a state where the pharmaceutical therapy was ineffective. The subject may have undergone laser therapy for treating glaucoma, such as selective laser trabeculoplasty (SLT). SLT may have effectively treated glaucoma until the condition worsened. The various methods provide ELT as a treatment after a previously administered treatment has failed or has become ineffective, thereby allowing drainage of the fluid that has accumulated in the anterior chamber. This includes re-administering ELT in the same or another part (quadrant) of the eye.

[0312] In one example, a prescription drug was administered to a subject with advanced glaucoma until the prescription became ineffective, selective laser trabeculoplasty (SLT) was administered as a laser therapy until SLT became ineffective, and a stent was implanted, which has since migrated. Because the subject had advanced glaucoma, treatment methods such as drugs or existing laser therapies may not have effectively treated the condition. In addition, due to the failure of the surgical treatment for stent placement, the stent was unable to drain the aqueous humor that had accumulated in the anterior chamber of the eye. By providing endoscopic laser treatment (ELT) according to various methods, perforations were created in the trabecular meshwork and / or Schlemm's canal, and the aqueous humor was allowed to drain. Thus, even when previous treatments had failed, various embodiments effectively drained the fluid accumulation.

[0313] In some embodiments, one or more previous treatments remain effective. In such cases, ELT is administered to provide combination treatment for glaucoma. Providing ELT in addition to other effective treatments results in increased drainage of aqueous humor from the anterior chamber of the eye. For example, ELT and SLT can be administered as a combination therapy to a subject with glaucoma who has undergone one failed treatment method (such as drug treatment). In some cases, this combination treatment can be administered to the patient during the same surgical visit.

[0314] During an ELT procedure, a physician guides the delivery tip of an optical fiber probe through a corneal incision in the eye and towards the trabecular meshwork. In some examples, various embodiments also include administering an anesthetic to the subject prior to making the incision and inserting the probe. Generally, the incision has a length of about 1 / 8 inch or less. In some examples, one or more sutures are used to close the incision after ELT treatment. The delivery tip is guided by the physician to a position near Schlemm's canal to create permanent perforations in the trabecular meshwork and / or Schlemm's canal. Through the perforations created by an excimer laser in Schlemm's canal and / or the meshwork, the fluid drainage in the anterior chamber of the eye is immediately improved. The perforations can also increase the outflow of aqueous humor and reduce the pressure in the eye. In some cases, a gonioscope, endoscope, or other light source is used by the physician to assist in positioning the delivery tip of the optical fiber probe. Generally, the physician will use a gonioscope to observe slight retrograde bleeding during the operation as a quality criterion, thereby allowing effective positioning of the fiber at the trabecular meshwork to create a channel into Schlemm's canal. A further quality criterion is the slight retrograde bleeding that can be observed during the operation, thus allowing effective positioning of the fiber at the trabecular meshwork to open Schlemm's canal.

[0315] Once the delivery tip is in a position close to the scleral venous sinus, a series of laser energy pulses are delivered to the trabecular meshwork. In an example, a 308 nm xenon chloride ultraviolet excimer laser is used in various embodiments. Compared with visible light or infrared lasers, the 308 nm xenon chloride ultraviolet excimer laser causes minimal thermal damage. In some examples, the excimer laser is an encapsulated xenon chloride (XeCl) excimer laser, such as the EXTRALASER manufactured by MLase AG. Different from argon and selective laser trabeculoplasty, ELT precisely excises tissue without causing thermal damage or scarring of surrounding tissues. Since ELT is a non-thermal procedure, the tissue reaction in the trabecular meshwork is not shown or activated postoperatively. The lack of heat generation in ELT allows for little activation of the postoperative tissue reaction and provides long-term stability of the decompression effect.

[0316] In addition, to avoid corneal absorption of the laser radiation, an optical fiber is used to deliver the energy. The delivery tip of the optical fiber probe includes an optical fiber jacketed in a metal such as stainless steel. In some examples, the delivery tip is angled (e.g., 0°, 15°, 30°, and 45° relative to the tip). The optical fiber probe includes an optical fiber suitable for UV light embedded in a handheld laser applicator. For example, the FIDO laser applicator manufactured by MLase AG can be used as the optical fiber probe.

[0317] To achieve easier drainage of aqueous humor (which results in a decrease in IOP), a total of about 10 ELT sites or perforations (each having a diameter of about 200 μm) are laser cut into the trabecular meshwork and / or the scleral venous sinus. In an example, about 10 pulses from an excimer laser source are applied to each eye. In some examples, more than about 10 pulses are applied to each eye. In contrast, stents and implants have a smaller individual diameter between about 80 μm and about 120 μm.

[0318] In some embodiments, an anesthetic is administered to the patient before the surgery. In some examples, the anesthesia is local. In some examples, the anesthetic includes anesthetic drops. In some cases, general anesthesia is administered to the patient. The eye is first anesthetized with eye drops, and then an anesthetic is injected around the eye. The anesthetic injection itself may cause some mild discomfort; there is a slight sense of pressure during the delivery of the anesthetic when injecting to anesthetize the eye, which not only prevents pain but also prevents excessive eye movement during the surgery.

[0319] Various embodiments provide for the use of ELT to treat glaucoma after a previously administered treatment has failed or become ineffective. The previous treatments include medical treatment, laser treatment, surgical treatment, or a combination thereof. For example, a patient may have previously been prescribed eye drops and may have undergone a selective laser trabeculoplasty (SLT) procedure, but the patient's condition has progressed to the point where those treatments are no longer effective. The various embodiments provide methods for treating a patient by administering ELT treatment to a patient with glaucoma who has previously experienced a failed treatment.

[0320] In various embodiments, the failed treatment is a prescribed drug or medical treatment, laser treatment, surgical treatment, or a combination thereof. Traditional methods for treating glaucoma include drug drops, laser treatment, and surgical treatment. Surgery has traditionally been a last resort after medical and laser therapies due to the relatively high complication rate and unpredictability of surgeries such as trabeculectomy.

[0321] Typically, a prescribed drug or medical treatment is a medicated eye drop, such as an alpha agonist, beta blocker, carbonic anhydrase inhibitor, cholinergic agonist, prostaglandin / prostamide analogue, or a combination thereof. Examples of laser treatment include trabeculoplasty, iridotomy, iridectomy, and combinations thereof. Examples of trabeculoplasty include argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). Examples of surgical treatment include the insertion of a shunt or implant, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscocanalostomy, or a combination thereof.

[0322] Medical treatment is the most common early treatment for glaucoma, and drug options include medicated eye drops, pills, or both. All drugs available for treating glaucoma must be taken regularly. Examples of medicated eye drops include alpha agonists, beta blockers, carbonic anhydrase inhibitors, cholinergic agonists, and prostaglandin / prostamide analogues.

[0323] Alpha agonists, such as apraclonidine and brimonidine, are used to reduce the production of fluid in the eye and improve the outflow of fluid from the eye. The drops are typically used two or three times a day. Apraclonidine is used for short-term use after laser treatment or to delay laser treatment. Brimonidine is licensed for long-term treatment of glaucoma but is contraindicated in children under two years of age. Side effects include dry mouth, tiredness, and general weakness. Patients may have a severe allergic reaction to the drops, causing the eyes to become increasingly red, sore, and sticky. Alpha agonists include preparations of brimonidine (ALPHAGAN, manufactured by Allergan, Inc.).

[0324] β-blockers include betaxolol, carteolol, levobunolol, and timolol, and are used to reduce the production of fluid in the eye. The drops are used once or twice a day and are generally not prescribed for anyone prone to chest or breathing problems. Side effects include slow pulse, dizziness, asthma, tiredness, depression, loss of libido, and impotence. β-adrenergic blocking drops include timolol (TIMOPTIC manufactured by Bausch and Lomb and 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&Lomb Pharmaceuticals, Inc.).

[0325] Carbonic anhydrase inhibitors, such as brinzolamide and dorzolamide, reduce the production of fluid in the eye. The drops are used two or three times a day alone, or twice a day if used with another drop. Side effects include red eyes, crusty eyelashes, fatigue, and a bitter taste in the mouth. Carbonic anhydrase inhibitors include the oral agents acetazolamide (DIAMOX SEQUELS manufactured by Teva Pharmaceuticals USA, Inc.) and methazolamide (NEPTAZANE manufactured by Perrigo Company plc, Dublin Ireland) and the ophthalmic drops brinzolamide (AZOPT manufactured by Alcon Laboratories Inc., a Novartis company, Novartis Pharmaceuticals Corporation, USA) and dorzolamide (TRUSOPT manufactured by Santen Pharmaceutical Co., Ltd.).

[0326] Cholinergic agonist drops, such as pilocarpine, are used to improve the outflow of fluid from the eye. When cholinergic agonist drops are used, the normal fluid flow pathway is improved. The drops are used three or four times a day. Miosis drops include pilocarpine hydrochloride solution manufactured by Akorn, Inc.

[0327] Prostaglandin / prostaglandin analogs include bimatoprost, latanoprost, tafluprost and travoprost. Drops are used to improve fluid outflow from the eye in a different way than usual. Drops are used once a day. Side effects include pink eyes, darkened irises, longer and darker eyelashes, and darkened skin around the eye sockets that usually improve over a period of time. Examples of prostaglandin FP-receptor (sensitive to prostaglandin F) agonists include latanoprost (XALATAN manufactured by Pfizer Inc.), bimatoprost (LUMIGAN manufactured by Allergan, Inc.), travoprost (TRAVATAN Z manufactured by Novartis Pharmaceuticals Corporation), unoprostone (RESCULA manufactured by SucampoPharmaAmericas, LLC) and tafluprost (ZIOPTAN manufactured by Akorn, Incorporated).

[0328] Several laser treatments are used in the treatment of glaucoma. Many different types of glaucoma are treated with different laser treatments. In open-angle glaucoma, laser treatment is used to lower the intraocular pressure (IOP) by increasing the outflow of aqueous humor from the eye (laser trabeculoplasty) or reducing the formation of aqueous humor (cyclophotocoagulation). In narrow-angle glaucoma, laser iridotomy is used to create a small hole in the iris to improve fluid outflow or iridoplasty is performed to tighten the iris and open the drainage angle.

[0329] Argon laser trabeculoplasty (ALT) is an effective treatment for chronic open-angle glaucoma. ALT was first performed with an argon laser, although the lasers used today are frequency-doubled YAG lasers that perform a similar function. Typically, the trabecular meshwork is targeted, and half of the eye is treated in a single treatment. The other half is treated later, if necessary. Treatment requires eye drops for anesthesia. The treatment can be used instead of eye drops, but is usually used as an adjunct to continued treatment with the drops. Different types of laser therapy or surgery may be needed, as the effects of ALT may wear off after a few years. Several follow-up appointments are needed after treatment so that the patient's IOP and inflammation can be monitored. Typically, most patients require anti-glaucoma drops long-term to control the IOP at the desired level.

[0330] Selective laser trabeculoplasty (SLT) is used to treat chronic open-angle glaucoma. SLT is similar to ALT, but uses a milder laser beam of larger size. In SLT, the laser is directed at the trabecular meshwork, but a laser with lower power than that used in ALT treatment is used. The best SLT results are produced when the entire 360-degree trabecular meshwork is treated in one session. Different from ALT, SLT can be repeated if the effect wears off. Several follow-up appointments are needed after treatment to monitor the patient's IOP and inflammation. Usually, most patients need antiglaucoma drops long term to keep the IOP at the desired level.

[0331] Transscleral photocoagulation, diode laser contact cyclophotocoagulation (Cyclodiode), or diode laser cyclolysis is used to treat chronic open-angle glaucoma. The laser is used to target the fluid-producing ciliary body. Treatment usually requires a general anesthetic or local anesthetic injection. Transscleral photocoagulation can be repeated if the IOP is considered not low enough or the effect gradually wears off over time. Diode laser contact cyclophotocoagulation is also recommended for many other forms of glaucoma where very high IOP occurs and traditional surgery is contraindicated or impossible. Patients who undergo diode laser contact cyclophotocoagulation usually need strong painkillers after treatment. Several follow-up appointments are needed after treatment to monitor the patient's IOP and inflammation. Usually, most patients need antiglaucoma drops long term to keep the IOP at the desired level.

[0332] Laser iridotomy is used to treat angle-closure and narrow-angle glaucoma. In laser iridotomy, a small hole is created with a Yag laser to relieve the narrow or closed angle. Fluid passes through the hole, inducing the iris to fall back from the drainage meshwork, and the fluid drains freely through the meshwork. Anesthetic eye drops are usually administered as an anesthetic. However, in some eyes, the iris does not fall back as needed, so other treatments are required. Even if the iris is in a good position, medication or surgery may still be needed to control the IOP. Laser post-treatment drops are required, usually in the form of steroids, and antiglaucoma drops may be needed temporarily or indefinitely.

[0333] Peripheral iridoplasty is used to treat angle-closure and narrow-angle glaucoma. Peripheral iridoplasty can be used when the iris does not fall back in an eye that has undergone laser iridotomy. An argon or frequency-doubled Yag laser is applied to the outer edge of the iris to cause the iris to contract away from the drainage meshwork and open the drainage angle. Anesthesia other than anesthetic drops may be required. Laser post-treatment drops are required, usually in the form of steroids, and antiglaucoma drops may be needed temporarily or indefinitely.

[0334] Several surgical treatments are available for the treatment of glaucoma. However, surgical options are usually a last resort and are reserved for patients with advanced glaucoma after medical and laser treatment options have proven ineffective in treating the condition.

[0335] Aqueous humor shunts are used to reduce intraocular pressure (IOP) in glaucoma by draining fluid from the interior of the eye into a bleb or blebs behind the eyelid. Aqueous humor shunts 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, CA, USA) and the Baerveldt Glaucoma Implant (manufactured by Advanced Medical Optics, Inc., Santa Ana, CA, USA). The shunt is made of a small silicone tube (less than 1 mm in diameter) attached to a plate. The tube removes aqueous humor from the interior of the eye and drains it into the plate located on the white of the eye (sclera). The plate is located under the skin of the conjunctiva, behind the eyelid.

[0336] Trabeculectomy is a surgical procedure used to treat glaucoma and is sometimes referred to as filtration surgery. During trabeculectomy, the doctor removes a piece of tissue in the drainage angle of the eye to create an opening. The opening is partially covered with a tissue flap from the sclera, the white part of the eye, and the conjunctiva, a thin transparent covering on the sclera. The newly created opening allows fluid to drain from the eye, bypassing the blocked drainage channels of the trabecular meshwork. A bleb forms as fluid flows through the new drainage opening, and the tissue over the opening rises to form a small bleb or bubble.

[0337] Trabeculotomy is a surgical procedure very similar to trabeculectomy. The doctor removes a piece of tissue in the drainage angle of the eye to create an opening. The newly created opening allows fluid to drain from the eye. Trabeculotomy surgery is only applicable to children.

[0338] During goniotomy, the doctor uses a goniolens to observe the structures in the front part of the eye or the anterior chamber. The physician creates an opening in the trabecular meshwork, a group of tiny channels located in the drainage angle where fluid leaves the eye. The newly created opening allows fluid to flow out of the eye. Goniotomy is only applicable to children.

[0339] Deep sclerectomy is a non-penetrating surgical procedure used to treat open-angle glaucoma. Deep sclerectomy involves removing the trabecular meshwork and the inner wall of the juxtacanalicular tissue, structures responsible for most of the outflow resistance in open-angle glaucoma. Aqueous humor outflow is enhanced, and the trabeculo-descemet's membrane (TDM) remains intact to control the outflow of aqueous humor through the filtration site.

[0340] In viscocanalostomy, tissue flaps are cut in the conjunctiva and sclera to expose a portion of the drainage canal (Schlemm's canal). The surgery includes creating superficial and deep scleral flaps, excising the deep scleral flap to create a scleral reservoir, and unroofing Schlemm's canal. A high-viscosity elastic gel is injected into Schlemm's canal to open and expand Schlemm's canal to allow increased fluid outflow from the anterior chamber. For example, the high-viscosity viscoelastic substance may include sodium hyaluronate. The tissue flaps are then closed. For example, the superficial scleral flap can be sutured watertight, trapping the viscoelastic substance until healing occurs.

[0341] Previously attempted treatments have proven ineffective in treating glaucoma in patients. Embodiments herein use an excimer laser to permanently perforate Schlemm's canal and / or the trabecular meshwork to form an internal outflow channel. This ablation performed with an excimer laser causes little thermal damage, thus minimizing the formation of inflammation and scar tissue. In contrast, due to the inflammatory and healing responses, other lasers (such as ruby lasers and argon lasers) cannot achieve permanent perforation of the trabecular meshwork. Thus, various embodiments use ELT to reconstruct the outflow of fluid from the eye without stimulating a healing response at the target tissue. Due to the absence of inflammation and scar tissue formation, the treatment methods of various embodiments require less recovery time than traditional surgical methods (such as the placement of implants).

[0342] In an embodiment, multiple pulses from an excimer laser are applied to a patient to create perforations in the trabecular meshwork and / or Schlemm's canal. ELT converts trabecular meshwork tissue into gas by photoablation. By permanently perforating Schlemm's canal and / or the trabecular meshwork, the fluid accumulated in the eye is immediately allowed to drain. In addition, since the perforations allow increased outflow of aqueous humor and fluid drainage, subsequent vision loss due to optic nerve damage caused by any accumulation is avoided.

[0343] Figure 40A flowchart of Embodiment 4100 is shown. Various embodiments relate to treating a patient with glaucoma using ELT. In various embodiments, energy pulses delivered from an excimer laser are at a location proximate to the trabecular meshwork. The various embodiments are performed after a patient with glaucoma has been administered a previous ineffective treatment. Treatments other than ELT include traditional medications, lasers, and surgical treatments. For example, pharmaceutical treatment methods involve pills, eye drops, or both. Typically, the prescribed medication or pharmaceutical treatment is a medicated 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 the insertion of a shunt or implant, trabeculectomy, trabeculotomy, goniotomy, deep sclerectomy, viscocanalostomy, or combinations thereof.

[0344] In various embodiments, ELT is administered even if other treatments have been previously administered and have been ineffective. For example, if a shunt has been placed in a subject's eye and has become displaced, it is still possible to provide ELT treatment. The ELT treatment provided will allow for the drainage of fluid that has accumulated in the eye by providing a permanent perforation of the trabecular meshwork and / or the scleral venous sinus.

[0345] The methods of the various embodiments include a preoperative analysis 4120, such as the diagnosis of the eye disease, the determination of the course of action based on the previous failed treatment method, the examination and / or visualization of the anterior chamber of the eye to assist in the placement of the laser probe, and the analysis of the number of laser pulses required for treatment. In various embodiments, excimer laser trabeculostomy (ELT) is used to treat glaucoma.

[0346] The method includes administering an anesthetic 4130 to the patient. Local anesthesia is typically employed, usually by instilling a local anesthetic such as tetracaine or lidocaine. Lidocaine and / or a longer-acting bupivacaine anesthetic can be injected into the area around (peribulbar block) or behind (retrobulbar block) the eye muscle cone to more completely immobilize the extraocular muscles and minimize pain sensation. Optionally, a facial nerve block using lidocaine and bupivacaine can be used to reduce eyelid squeezing. In some cases, such as for children, patients with traumatic eye injuries, and neurologically or uncooperative patients and animals, general anesthesia is administered under cardiovascular monitoring. To prepare the surgical area, appropriate aseptic precautions must be taken, including the use of an antibacterial agent such as povidone iodine and the use of sterile drapes, gowns, and gloves. In some cases, an eyelid retractor is inserted to keep the eyelids open.

[0347] Physician 4140 makes a small incision in the patient's eye. Before performing the ELT procedure, a small incision is made in the cornea of the eye to allow the introduction of a laser probe. Typically, the incision is about 1 / 8 inch or less. During the ELT procedure, the doctor guides the delivery tip of the fiber optic probe through the corneal incision in the eye and towards the trabecular meshwork. The delivery tip is guided by the physician to a position near the scleral venous sinus. The doctor may use a gonioscope, an endoscope, and / or a light source to assist in positioning the delivery tip. By providing the laser probe at a position near or crossing the scleral venous sinus, more surface area is delivered with the laser compared to the situation where the laser is in a position parallel or perpendicular to the scleral venous sinus, resulting in more perforations being created with fewer laser pulses. Thus, the arrangement of the delivery tip at a position near the scleral venous sinus achieves optimal photoablation and perforation formation in the meshwork and / or scleral venous sinus for fluid drainage. When creating perforations in the tissue, the orientation and positioning of the delivery tip are critical because achieving the placement of the perforations relative to the scleral venous sinus in the meshwork provides optimal drainage.

[0348] Once the delivery tip is in a position near the scleral venous sinus, Physician 4150 applies ELT treatment to the patient by delivering a series of laser energy pulses to the trabecular meshwork and / or scleral venous sinus. The physician applies pulsed photoablation energy to create ELT sites or perforations in the trabecular meshwork and / or scleral venous sinus. In some examples, the physician creates 10 ELT sites in the patient's eye. In some examples, the physician creates more than 10 ELT sites. A small amount of blood reflux from the scleral venous sinus confirms each opening. The fiber optic probe is removed from the eye. Notably, the IOP decreases immediately after the ELT procedure is administered.

[0349] After applying the ELT treatment, Physician 4160 closes the incision. Typically, the physician uses sutures to close the incision. Some physicians place sutures in the incision, and other physicians reserve the sutures for when there is persistent leakage.

[0350] The methods of various embodiments include 4170 analyzing the postoperative results and 4180 reporting the results and / or scheduling a postoperative follow-up appointment with the patient after the surgery. For example, the physician's analysis may include observing a small amount of blood reflux from the scleral venous sinus to confirm each opening. By observing the blood reflux and drainage of the aqueous humor, the physician can immediately verify the effectiveness of the laser treatment. In turn, the physician can report the results to the patient, prescribe postoperative medications such as topical antibiotics and steroid drops, and schedule the patient's subsequent postoperative follow-up. For example, the patient uses topical antibiotics and steroid drops for 1 to 2 weeks after the surgery.

[0351] Systems such as those shown in Figures 3 - 6 21 - 33 and / or 36 - 39 can be used in various embodiments. Such systems may includeFigure 41 The components shown in Figure 41 is a diagram of a system 6300 for treating glaucoma according to various embodiments. The treatment system 6300 includes an interactive user interface 6310 (exemplary user interface 410), an optical fiber probe 6320 (examples of optical fiber probes 102, 104, 500, 4200, 5200), a controller 6330, and an excimer laser trabeculostomy (ELT) system 6340. The excimer laser system 6340 includes an excimer laser 6350 and a gas cylinder 6360. The excimer laser system 6340, the interactive user interface 6310, and the optical fiber probe 6320 are communicatively coupled to the controller 6330. Additionally, the excimer laser system 6340 may be contained within a housing that includes the interactive user interface, and the optical fiber probe may be connected to the housing for use during ELT treatment.

[0352] The controller 6330 has a processor. The processor generally includes a chip, such as a single-core or multi-core chip, to provide a central processing unit (CPU), such as a chip from Intel or AMD. The controller 6330 provides control of the treatment system 6300 to an operator (i.e., a physician, surgeon, or other medical professional), including programming of the optical fiber probe, output of the laser signal, and control of the transmission of laser energy from the laser source 6350 to the optical fiber probe 6320 that delivers the laser transmission.

[0353] The controller 6330 may include software, firmware, and / or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction set, and / or data recorded on a non-volatile computer-readable storage medium. The firmware may be embodied as code, instructions, or instruction set and / or data hard-coded (e.g., non-volatile) in a memory device. As used in any of the embodiments herein, "circuitry" may include, for example, alone or in any combination, hard-wired 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 6330 may include a hardware processor coupled to a non-volatile computer-readable memory that contains instructions executable by the processor to cause the controller to perform various functions of the treatment system 6300 as described herein, including controlling laser delivery and programming the number of laser pulses that can be delivered by the optical fiber probe 6320 using the interactive user interface 6310.

[0354] The laser system 6340 includes an excimer laser 6350 and a gas cylinder 6360 for supplying an appropriate gas mixture to the laser 6350. The excimer laser 6350 is in the form of an ultraviolet 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 cylinder 6360) is generally a gas mixture containing an inert gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high voltage, a pseudomolecule called an excimer (or an exciplex in the case of an inert gas halide) is produced, which can only exist in an energized state and can generate laser light within the UV range.

[0355] Laser action occurs in excimers because they have a bound (associated) excited state but a repulsive (dissociative) ground state. Noble gases such as xenon and krypton are highly inert and generally do not form chemical compounds. However, when in an excited state (induced by a discharge or a high-energy electron beam), they can form transiently bound molecules with themselves (excimers) or with halogens (exciplexes) such as fluorine and chlorine. The excited compound can release its excess energy by undergoing spontaneous or stimulated emission, thereby producing a strongly repulsive ground-state molecule that dissociates very rapidly (on the picosecond timescale) back into two unbound atoms. This creates a population inversion. The excimer laser 6350 of the present system 6300 is a XeCl excimer laser and emits a wavelength of 308 nm.

[0356] Transverse placement method in the ELT

[0357] One of the main causes of irreversible blindness is glaucoma. Normally, fluid freely flows through the anterior chamber of the eye and exits through a drainage system that includes the trabecular meshwork and the scleral venous sinus. When an individual has glaucoma, an obstruction in the trabecular meshwork or the scleral venous sinus prevents the fluid from draining and causes an increase in pressure within the eye. If left untreated, the increased pressure in the eye can damage the optic nerve, leading to a gradual loss of vision and ultimately blindness.

[0358] Traditional methods for treating glaucoma include drug therapy, laser therapy, surgical treatment, or a combination thereof to reduce the pressure within the eye. Drug therapy (such as medicated eye drops) and laser therapy (such as selective laser trabeculoplasty (SLT)) generally cannot effectively treat 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 and require a high degree of precision to avoid displacement of the implant. For example, if the stent is not properly placed on the first attempt, it may be very difficult to place the stent at all.

[0359] Various embodiments use excimer laser trabeculostomy (ELT) to provide treatment for glaucoma. During an ELT procedure, a laser probe is positioned adjacent to the scleral venous sinus to create perforations in the trabecular meshwork and / or the scleral venous sinus, the perforations forming lines transverse to the scleral venous sinus. By permanently perforating the scleral venous sinus and / or the trabecular meshwork, fluid accumulating in the anterior chamber of the eye is immediately allowed to drain. Positioning the laser probe at a location adjacent to the scleral venous sinus provides optimal results by providing a larger surface area for photoablation of the laser. By applying the laser at a location adjacent to the scleral venous sinus, each laser pulse provides photoablation of a larger surface area, resulting in larger perforations from fewer laser pulses.

[0360] In open-angle glaucoma (OAG), obstruction of fluid outflow at the trabecular meshwork and the inner wall of the scleral venous sinus is the primary cause of elevated intraocular pressure (IOP). Various embodiments use an excimer laser to perforate the trabecular meshwork and / or the scleral venous sinus to create an internal outflow channel, thereby increasing the drainage of a fluid known as aqueous humor from the anterior chamber of the eye. The perforations also increase the flow of aqueous humor and reduce the pressure in the eye.

[0361] The methods of various embodiments use ELT to reconstruct fluid outflow from the anterior chamber of the eye without causing a healing response at the target tissue. ELT converts trabecular meshwork tissue into gas by photoablation. Ablation with an excimer laser causes little thermal damage, thereby minimizing the formation of inflammatory and scar tissue. Unlike argon and selective laser trabeculoplasty, ELT precisely excises tissue without causing thermal damage or scarring of surrounding tissue. Additionally, due to the inflammatory and healing response, other lasers (such as ruby and argon lasers) are unable to achieve permanent perforation of the trabecular meshwork. Due to the absence of inflammatory and scar tissue formation, the methods of various embodiments require less recovery time than traditional laser treatments or surgical treatments (such as the placement of implants).

[0362] During an ELT procedure, a physician guides the delivery tip of an optical fiber probe through a corneal incision in the eye and toward the trabecular meshwork. In some embodiments, the methods of various embodiments include administering an anesthetic to the subject prior to forming the incision and inserting the probe. Typically, the incision has a length of about 1 / 8 inch or less. The delivery tip is guided by the physician to a location adjacent to the scleral venous sinus. In various embodiments, the physician uses a light source such as a gonioscope, an endoscope, or other light source to assist in positioning the delivery tip. Additionally, the light source helps the physician verify the effectiveness of the laser treatment by visualizing the drainage of aqueous humor and blood reflux during treatment.

[0363] Once the delivery tip is in a position close to the trabecular meshwork, the physician delivers a series of laser energy pulses to the trabecular meshwork, and perforations can be formed that are lines, curves, etc. transverse to the trabecular meshwork (e.g., the perforations can be at different heights of the trabecular meshwork to ensure that a portion of the trabecular meshwork adjacent to the trabecular meshwork is perforated). Thus, the arrangement of the delivery tip at successive positions transverse to the trabecular meshwork achieves optimal photoablation and perforation formation in the meshwork and / or trabecular meshwork. Thus, the generation of multiple perforations results in a higher likelihood of immediate drainage of aqueous humor from the anterior chamber of the eye, and thus in a successful surgery and treatment for glaucoma.

[0364] ELT treatment creates a long-term opening that directly connects the anterior chamber of the eye to the trabecular meshwork using an excimer laser. Various embodiments use a 308 nm xenon chloride ultraviolet excimer laser, which causes minimal thermal damage compared to visible or infrared lasers. In various embodiments, the excimer laser is an encapsulated xenon chloride (XeCl) excimer laser, such as the EX TRA laser manufactured by MLase AG. Additionally, to avoid corneal absorption of the laser radiation, an optical fiber is used to deliver the energy from the excimer laser. The delivery tip of the fiber optic probe includes an optical fiber jacketed in a metal such as stainless steel. In some examples, the delivery tip is angled (e.g., 0°, 15°, 30°, and 45° relative to the tip). The fiber optic probe includes an optical fiber suitable for UV light embedded in a handheld laser applicator. For example, the FIDO laser applicator manufactured by MLaseAG can be used as the fiber optic probe.

[0365] To achieve easier aqueous humor drainage to reduce IOP, a total of about 10 ELT perforations (each having a diameter of about 200 μm) are laser cut into the trabecular meshwork and / or trabecular meshwork. In contrast, stents and implants have a smaller individual diameter between about 80 μm and about 120 μm. In some embodiments, about ten pulses are applied to each eye from the excimer laser source. The energy pulses can be applied to one quadrant of the eye, the inferonasal quadrant, but can be applied to other quadrants. In some embodiments, more than about ten emissions can be applied to each eye and can be applied to the inferonasal quadrant and / or multiple eye quadrants. Since ELT is a non-thermal procedure, tissue reaction in the trabecular meshwork is not shown or activated postoperatively. The lack of heat generation in ELT allows for little activation of the postoperative tissue reaction and provides long-term stability of the decompression effect. Additionally, unlike traditional glaucoma treatments with shunts or stent placement, the stability of the trabecular meshwork treated with ELT remains unchanged.

[0366] Glaucoma patients suffer from increased intraocular pressure due to the obstruction of fluid outflow from the eye. Various embodiments use an excimer laser to create perforations in the trabecular meshwork and / or Schlemm's canal of the eye. ELT treats open-angle glaucoma at the site of occurrence by increasing the permeability of the trabecular meshwork. During ELT, the laser creates a direct connection between the anterior chamber of the eye and Schlemm's canal using an optical fiber probe that physically contacts the trabecular meshwork.

[0367] The methods of various embodiments include inserting a probe into the eye of a subject suffering from glaucoma, adjusting the placement of the probe to successive positions to form successive perforations transverse to Schlemm's canal in the eye by applying multiple pulses from an excimer laser source as the probe approaches the trabecular meshwork and / or Schlemm's canal, thereby treating glaucoma by forming multiple perforations in Schlemm's canal and / or the trabecular meshwork. The perforations allow fluid to drain immediately from the anterior chamber of the eye. The perforations also allow an increase in the flow of aqueous humor in the eye and a reduction in intraocular pressure.

[0368] Figure 42 A flowchart of embodiment 7100 of the methods of various embodiments is shown. Various embodiments relate to treating patients suffering from glaucoma with ELT. In various embodiments, energy pulses from an excimer laser are delivered by an optical fiber probe at a position forming a transverse line or curve relative to Schlemm's canal. In some examples, the method includes a preoperative analysis 7110, such as the diagnosis of an eye disease and an examination and / or visualization of the anterior chamber of the eye to assist in the placement of the laser probe. In various embodiments, excimer laser trabeculostomy (ELT) is used to treat glaucoma.

[0369] In some embodiments, the method includes administering an anesthetic to the patient 7120. Local anesthesia is typically employed, usually by instilling a local anesthetic such as tetracaine or lidocaine. Lidocaine and / or a longer-acting bupivacaine anesthetic can be injected into the area around (peribulbar block) or behind (retrobulbar block) the eye muscle cone to more completely immobilize the extraocular muscles and minimize pain sensation. Optionally, a facial nerve block using lidocaine and bupivacaine can be used to reduce eyelid squeezing. In some cases, such as for children, patients with traumatic eye injuries, and nervous or uncooperative patients and animals, general anesthesia is administered under cardiovascular monitoring. To prepare the surgical area, appropriate aseptic precautions must be taken, including the use of an antibacterial agent such as povidone iodine and the use of sterile drapes, gowns, and gloves. In some cases, an eyelid speculum is inserted to keep the eyelids open.

[0370] The physician forms a small incision in the patient's eye 7130. Prior to performing the ELT procedure, a small incision is made in the cornea of the eye to allow the introduction of the optical fiber probe. Typically, the incision is about 1 / 8 inch or less.

[0371] During excimer laser trabeculostomy, a physician guides the delivery tip of an optical fiber probe through a corneal incision in the eye and toward the trabecular meshwork. The delivery tip 7140 is guided by the physician to a continuous position transverse to the sinus venosus sclerae, at which position pulses are delivered (e.g., see Figure 43 and the attached description). The physician may use a gonioscope, an endoscope, and / or a light source to assist in positioning the delivery tip. By providing the laser probe at multiple positions to emit transversely or crosswise relative to the sinus venosus sclerae, energy from the excimer laser is delivered at multiple heights where the sinus venosus sclerae may be located, thereby increasing the likelihood of perforating the trabecular meshwork that is actually connected to the sinus venosus sclerae. Thus, the arrangement of the delivery tip at a position transverse to the sinus venosus sclerae enables optimal photoablation and the formation of perforations in the meshwork and / or the sinus venosus sclerae.

[0372] Once the delivery tip is at a given position in the continuous transverse position, the physician 7150 applies ELT treatment to the patient by delivering a series of laser energy pulses to the trabecular meshwork and the sinus venosus sclerae. The physician applies pulsed photoablation energy. In some examples, the physician forms about 10 ELT sites in the patient's eye. In some examples, the physician produces more than about 10 ELT sites in each eye of the patient. A small amount of blood reflux from the sinus venosus sclerae confirms each opening. The optical fiber probe is removed from the eye. The IOP is reduced immediately after the ELT procedure is administered.

[0373] After applying the ELT treatment, the physician 7160 closes the incision. Typically, the physician uses sutures to close the incision. Some physicians place sutures in the incision, and other physicians leave the sutures, e.g., in cases involving persistent leakage.

[0374] The methods of various embodiments include 7170 analyzing the postoperative results and 7180 reporting the results and / or scheduling a postoperative follow-up appointment with the patient after the surgery. For example, the physician's analysis may include observing a small amount of blood reflux from the sinus venosus sclerae to confirm each opening. By observing the blood reflux and drainage of the aqueous humor, the physician can immediately verify the effectiveness of the laser treatment. In turn, the physician can report the results to the patient, prescribe postoperative medications, such as topical antibiotics and steroid drops, and schedule any subsequent postoperative follow-up for the patient. Topical antibiotics and steroid drops are typically prescribed and used by the patient for 1 to 2 weeks after the surgery.

[0375] Figure 43 is a partial perspective view of the anatomical structures within the anterior chamber of the eye, depicting a structure similar to Figure 2The corneal-scleral angle, where the location of the emission applied to the trabecular meshwork is depicted by x and shown as forming a horizontal line. As described herein, ELT surgery is performed by perforating the trabecular meshwork 9, 13 of the eye. This allows the fluid in stream 1 to pass through the trabecular meshwork 9, 13 and into the scleral venous sinus 11, thereby reducing the intraocular pressure in the eye. As shown, the trabecular meshwork 9, 13 may have a height of distance A, while the scleral venous sinus 11 (which is hidden from the ELT operator beneath the trabecular meshwork 9, 13) may have a height of B. Since the operator may not be able to see the scleral venous sinus 11 beneath the trabecular meshwork 9, 13, the operator may miss the scleral venous sinus by one or more pulses, and the ELT surgery may fail or be less effective. If the operator applies the emission in a straight line, each emission has the potential to miss the scleral venous sinus, thus potentially resulting in a failed surgery.

[0376] As Figure 43 shown, pulses 7205, 7210 may be applied in a line transverse to the scleral venous sinus to ensure that at least some of the pulses are applied correctly and form perforations through the trabecular meshwork 9, 13 and into the scleral venous sinus 11. In other words, since pulses 7205 and 7210 are applied in a line that transversely crosses the width C (where the trabecular meshwork 9, 13 and the scleral venous sinus 11 are actually aligned), some of the pulses (e.g., pulse 7205) are successful, thus helping to increase the likelihood of a successful surgery.

[0377] In Figure 43 the example, a total of nine pulses (x) are shown, and at least six of these pulses are successful, where the seventh at the boundary may be successful. Thus, the method of applying consecutive pulses along a transverse line relative to the scleral venous sinus can increase the number of successful outcomes by ensuring that at least some of the pulses are successful. This method may be particularly useful if the patient has a small scleral venous sinus or if the operator has poor visibility of a particular eye. In other words, rather than having to guess where the scleral venous sinus is, the operator can take a systematic approach as Figure 43 shown to ensure a successful surgery. In various embodiments, if a certain number of successful emissions or perforations are desired, the total number of emissions can be increased. In this way, the operator can account for a certain number of pulses that may not be successful. For example, in Figure 43 nine pulses are applied, where at least six are successful. If at least ten successful pulses are desired, the operator can apply, for example, fifteen pulses or some number greater than ten pulses, thus leaving room for the transverse line to have some outliers that are not successful.

[0378] Personalization of the excimer laser fiber

[0379] Glaucoma is a group of eye diseases that cause damage to the optic nerve and lead to vision loss. Although glaucoma can occur at any age, it is more common in the elderly and is one of the leading causes of blindness in people over 60 years old. The main risk factor for glaucoma is high intraocular pressure, in which the pressure inside the eye is higher than normal. The elevated intraocular pressure can cause optic nerve atrophy, subsequent visual field disorders, and ultimately blindness if left untreated.

[0380] Intraocular pressure is a function of the aqueous humor fluid produced by the ciliary processes of the eye and its drainage through a tissue called the trabecular meshwork. The trabecular meshwork is an area of tissue in the eye located around the base of the cornea and is responsible for draining the aqueous humor into a lymphatic-like blood vessel in the eye called the canal of Schlemm, which then delivers the drained aqueous humor into the bloodstream. The proper flow and drainage of the aqueous humor through the trabecular meshwork maintains the normal balance of pressure inside the eye. In open-angle glaucoma (the most common type of glaucoma), degeneration or blockage of the trabecular meshwork can cause a slowdown or complete blockage of the drainage of the aqueous humor, causing fluid accumulation, which increases the intraocular pressure. Under the strain of this pressure, the optic nerve fibers become damaged and may ultimately die, resulting in permanent vision loss.

[0381] If treated early, the progression of glaucoma can be slowed or stopped. Depending on the type of glaucoma, treatment options may include eye drops, oral medications, surgery, laser treatment, or a combination of any of these. For example, the treatment of open-angle glaucoma can include surgical treatments such as filtration surgery, in which an opening is created in the sclera of the eye and a portion of the trabecular meshwork is removed, and surgical implantation of a stent or implant (i.e., a drainage tube), in which a microshunt is positioned inside the eye to assist in fluid drainage. However, such treatments are highly invasive and may have many complications, including leakage, infection, low intraocular pressure (e.g., hypotony), and require long-term postoperative monitoring to avoid late complications.

[0382] Recently, minimally invasive laser treatment has been used to treat glaucoma. In such treatments, a surgeon uses a laser to thermally modify and / or completely pierce various structures, including the trabecular meshwork and / or Schlemm's canal. For example, laser trabeculostomy is a procedure in which a surgeon guides the working end of a laser fiber through an incision in the cornea of the eye and toward the trabecular meshwork and applies laser energy to disrupt portions of the meshwork to create channels in the meshwork that allow aqueous humor to flow more freely into Schlemm's canal. A high degree of precision is required during minimally invasive laser treatment. For example, a surgeon must be able to position the laser fiber appropriately in the correct location relative to the trabecular meshwork and Schlemm's canal to ensure that the resulting perforations or channels created by the laser are optimal. However, current laser fiber options are limited. Most laser fibers are similarly constructed and have similar characteristics. As a result, surgeons have very few options when choosing the laser fiber they select. Instead, surgeons are forced to use laser fibers that lack certain qualities (such as the desired feel, feedback, and overall functionality of the laser fiber) that a given surgeon requires when performing certain procedures. Thus, the laser treatment may be inadequate because the desired drainage may not be achieved, and as a result, the patient may require additional postoperative procedures to reduce intraocular pressure. For example, in the case of current laser fiber options, a surgeon may position the laser too close or too far from the trabecular meshwork and Schlemm's canal and / or position the laser at an inappropriate angle relative to the trabecular meshwork and Schlemm's canal, resulting in unintended collateral tissue damage or creating channels that are inadequate and do not provide the desired drainage.

[0383] Various embodiments provide personalized laser probes for a laser system. The laser probes are single-use disposable probes that are configured to be used with a laser unit. The laser unit includes a laser source that is configured to generate laser energy that will be provided to the laser probe coupled thereto. Each laser probe is a handheld device that includes a handheld body and an optical fiber extending therethrough, the optical fiber including an optical fiber core. When the laser probe is coupled to the laser unit, the optical fiber core is adapted to direct laser radiation from the laser source to the delivery tip of the probe for transmitting laser energy to a desired treatment area. Each laser probe includes one or more features that are customized for a given user (e.g., a surgeon or other medical professional performing a procedure involving laser treatment).

[0384] The specific features of any given probe are based on the individual preferences of a given user. The characteristics can generally relate to the shape and / or size of portions of the probe and the physical mass of portions of the probe. In some embodiments, based on the personal preferences of the surgeon, the handheld body of a given probe can include specific dimensions, including width, length, and diameter, to improve fit and feel. In some embodiments, the profile of the delivery tip of the optical fiber core can be shaped based on the preferences of the surgeon, where the tip can be angled at a desired angle to enable more precise control of the surgery. In some embodiments, the distal end of the laser probe can have a specific degree of flexibility or rigidity based on the preferences of the surgeon, further providing an improved sense of feel and operability of the surgery.

[0385] Personalization of the laser probe provides the surgeon with customized fit, feel, and functionality. The surgeon is better equipped to successfully perform a given surgery that might otherwise prove difficult due to the lack of variation between laser fiber options. In particular, the laser probes and laser units of various embodiments can be used to permanently treat glaucoma using laser trabeculostomy. By providing a personalized laser probe, the surgeon is more comfortable with the laser probe and is able to perform the surgery with the required precision to ensure optimal laser treatment of the target area. In particular, by using a personalized laser probe, the surgeon is able to better position the laser pulse transverse to the trabecular meshwork to create a perforation or channel, thereby improving fluid drainage, increasing the flow of aqueous humor, and reducing the pressure in the eye. Positioning the laser probe at a location transverse to the trabecular meshwork provides an improved perforation and thus improved fluid drainage by providing a greater surface area for photoablation by the laser, resulting in optimal results.

[0386] Various embodiments provide a personalized laser probe for a laser system. The laser probe is a single-use disposable probe that is configured to be used with a laser unit. The laser unit includes a laser source for generating laser energy that will be provided to the laser probe coupled thereto. Each laser probe is a handheld device that includes a handheld body and an optical fiber extending therethrough, the optical fiber including an optical fiber core. When the laser probe is coupled to the laser unit, the optical fiber core is adapted to direct laser radiation from the laser source to the delivery tip of the probe for transmission of laser energy to a desired treatment area.

[0387] Each laser probe includes one or more features customized for a given user (e.g., a surgeon or other medical professional performing a procedure involving laser therapy). Personalization of the laser probe provides customized fit, feel, and function for the surgeon. The surgeon is better equipped to successfully perform a given procedure, which might otherwise prove difficult due to a lack of variation among the laser fiber options. In particular, the laser probes and laser units of various embodiments can be used to permanently treat glaucoma using laser trabeculostomy. By providing a personalized laser probe, the surgeon is more comfortable with the laser probe and is able to perform the procedure with the required precision to ensure optimal laser treatment of the target area. In particular, by using a personalized laser probe, the surgeon is able to better position the laser pulse transverse to the trabecular meshwork to create a perforation or channel, thereby improving fluid drainage, increasing the flow of aqueous humor, and reducing pressure in the eye. Positioning the laser probe at a location transverse to the trabecular meshwork provides optimal results by providing a greater surface area for photoablation of the laser, thereby improving the perforation and thus the fluid drainage.

[0388] Systems of various embodiments can be well-suited for intraocular surgery where laser treatment of target tissue is desired. In particular, the laser sources and laser probes of various embodiments can be used to treat glaucoma and can be used to perform laser trabeculostomy. However, it should be noted that systems in accordance with the present disclosure can be used for any laser treatment of various conditions, including other eye diseases (i.e., diabetic eye diseases such as proliferative diabetic retinopathy or macular edema, age-related macular degeneration, retinal tears, and cases of retinopathy of prematurity, as well as laser-assisted in situ keratomileusis (LASIK) for correcting refractive errors such as myopia (nearsightedness) or astigmatism) and other conditions in general and other practice areas (non-ophthalmic practice areas).

[0389] Figure 44A excimer laser system is shown, which includes a laser unit system 8100 and a plurality of laser probes 8200(1), 8200(2), 8200(n) that can be coupled 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 cylinder 8106 for providing an appropriate gas mixture to the laser 8104. The excimer laser 8104 is in the form of an ultraviolet 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 cylinder 8106) is typically a gas mixture containing an inert gas (e.g., argon, krypton, or xenon) and a reactive gas (e.g., fluorine or chlorine). Under appropriate conditions of electrical stimulation and high voltage, a pseudomolecule called an excimer (or exciplex in the case of an inert gas halide) is produced, which can only exist in an energized state and can generate laser light in the UV range.

[0390] Laser action occurs in excimers because they have a bound (associated) excited state but a repulsive (dissociative) ground state. Noble gases such as xenon and krypton are highly inert and generally do not form chemical compounds. However, when in an excited state (induced by a discharge or a high-energy electron beam), they can form temporarily bound molecules with themselves (excimers) or with halogens (exciplexes) such as fluorine and chlorine. The excited compound can release its excess energy by undergoing spontaneous or stimulated emission, thereby producing a strongly repulsive ground state molecule that dissociates back into two unbound atoms very rapidly (on the picosecond timescale). This forms a population inversion. The excimer laser 8104 of the present system 8100 is a XeCl excimer laser and emits a wavelength of 308 nm.

[0391] As described in more detail herein, many components of the laser unit system 8100 can be contained within a housing (such as a movable platform) to provide an environment (e.g., an operating room, an operating theater, an outpatient environment, etc.) in which a surgery is to be performed, and the probes 8200(1)-8200(n) can be connected to the housing for use during treatment. When the probe 8200 is coupled to the housing, the optical fiber core of the probe 8200 is coupled to the laser source 8102 and is adapted to direct laser radiation from the laser source 8102 through the optical fiber and to the treatment area.

[0392] The controller 8108 provides control to an operator (i.e., a surgeon or other medical professional) over the output of the laser signal (from the excimer laser 8104 to the optical fiber core of the probe 8200), and in turn controls the transmission of laser energy from the probe 8200. The controller 8108 may include software, firmware, and / or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction set, and / or data recorded on a non-transitory computer-readable storage medium. The firmware may be embodied as code, instructions, or instruction set and / or data hard-coded (e.g., non-transitory) in a memory device. As used in any of the embodiments herein, "circuitry" may include, for example, hard-wired circuitry, programmable circuitry (such as a computer processor including one or more individual instruction processing cores), state machine circuitry, and / or firmware storing instructions executable by the programmable circuitry, either individually or in any combination. For example, the controller 8108 may include a hardware processor coupled to a non-transitory computer-readable memory that contains instructions executable by the processor to cause the controller to perform the various functions of the laser system 8100 as described herein.

[0393] Figure 4 An embodiment of an excimer laser unit 100 (e.g., laser system 8100) disposed in an instrument 400 is shown. As previously described, one or more components of the system 100 may be included within the instrument 400. In the present embodiment, the laser source 8102 (including the excimer laser 8104 and the gas cylinder 1806) and the controller 8108 are included within a housing 402. The housing 402 has wheels 404 and is portable. The instrument 400 also includes a push-pull handle 405, which aids in the portability of the instrument 400. The instrument 400 further includes a connection port 406 for receiving the connection end of the laser probe 8200 to establish a connection between the optical fiber core of the probe 8200 and the laser source 8102. The instrument 400 also includes various inputs for the operator, such as an emergency stop button 410 and a power switch 412. The instrument 400 further includes a foot pedal 414 that extends from the housing 402 and is operable to provide control over the emission from the excimer laser 8104 to the optical fiber core of the probe 8200. The instrument 400 also includes a display 416, which may be in the form of an interactive user interface. In some examples, the interactive user interface displays patient information, machine settings, and program information. As previously described, the operator may manually input laser probe data via the interactive user interface, thereby providing such data to the controller 8108. However, in some embodiments, the data may be automatically read from a readable device or tag on the probe 8200 via an associated reader of the system 8100.

[0394] As shown, various embodiments provide a plurality of personalized laser probes 8200(1)-8200(n) for use with an excimer laser unit 8100. The laser probes 8200(1)-8200(n) are single-use, disposable probes that are configured to be used with the laser unit, one at a time. When the laser probes 8200(1)-8200(n) are coupled to the laser unit (via a connection portion 406), the fiber optic core of the probe 8200 is adapted to direct laser radiation from the excimer laser 8104 to the delivery tip of the probe for delivery of the laser energy to a desired treatment area. Thus, only a single excimer laser unit 8100 is required, and a plurality of differently configured probes 8200(1)-8200(n) can be used with the unit 8100.

[0395] Figure 5 and Figure 6 An embodiment of a probe 500 that may be used with an excimer laser system 8100 is shown (eg, one of probes 8200 ( 1 )- 8200 ( n )). Figure 46 and 47 The Figure 6 AA and BB of the probe 500. As shown, the optical fiber core 518 extends through the probe 500 and forms a part of the connector 502. The protective sheath 516 surrounds the optical fiber core 518. In some examples, the protective sheath 516 is a protective plastic or rubber sheath. The optical fiber core 518 further forms a part of the delivery tip 506 of the probe 500. The metal sheath 520 surrounds the optical fiber core 518 and the optical fiber 520. In some cases, the stainless steel sheath 520 surrounds and protects the optical fiber core 518.

[0396] Each laser probe includes one or more features customized for a given user (e.g., a surgeon or other medical professional performing a procedure involving laser treatment). The specific features of any given probe are based on the individual preferences of the given user. The characteristics can generally relate to the shape and / or size of the portions of the probe and the physical quality of the portions of the probe. In some embodiments, based on the surgeon's personal preferences, the handheld body 508 of a given probe can include specific dimensions, including width, length, and diameter, to improve fit and feel.

[0397] In some embodiments, the profile of the delivery tip 506 of the fiber optic core can be shaped based on the surgeon's preference, where the tip can be tilted at a desired angle to enable more precise control of the procedure. Figure 48 An enlarged view of the distal portion of the probe is shown. Figure 49A and Figure 49B An enlarged view of the delivery tip 506 of the probe is shown with different bevel angles 507. For example, Figure 49AAs shown, the bevel angle θ1 can be greater than the bevel angle θ1, as determined by the user's personal preference. Additionally or alternatively, the distal end of the laser probe can have a specific degree of flexibility or rigidity based on the preference of the surgeon, thereby further providing an improved feel and operability for the surgery. For example, Figure 50 and 51 An enlarged view of the distal portion 506a (curved distal portion 506b) of the probe bent in different directions is shown. Thus, the outer sheath 520 surrounding the optical fiber core 518 can include certain materials having properties that allow for the desired bending or rigidity.

[0398] The personalization of the laser probe provides the surgeon with customized fit, feel, and functionality. The surgeon is better equipped to successfully perform a given surgery that might otherwise prove difficult due to the lack of variation between laser fiber options. In particular, the laser probes and laser units of various embodiments can be used to permanently treat glaucoma using laser trabeculostomy. For example, during laser trabeculostomy using a laser system and probe, the physician guides the delivery tip of the probe through a corneal incision in the eye and toward the trabecular meshwork. The physician can use a gonioscope and / or a light source to assist in positioning the delivery tip. In some examples, the physician uses a light source (such as a gonioscope, an endoscope, or other light source) to assist in adjusting the placement of the probe.

[0399] By providing a personalized laser probe, the surgeon is more comfortable with the laser probe and is able to perform the surgery with the required precision to ensure optimal laser treatment of the target area. For example, the surgeon is able to better position the laser pulses transversely to the scleral venous sinus. Once the delivery tip is in a position transverse to the scleral venous sinus, the physician delivers a series of laser energy pulses to the trabecular meshwork. By providing the laser probe in a position transverse to the scleral venous sinus or intersecting the scleral venous sinus, the laser is delivered to a larger surface area compared to the case where the laser is in a position parallel or perpendicular to the scleral venous sinus. Thus, the arrangement of the delivery tip in a position transverse to the scleral venous sinus enables optimal photoablation and channel formation in the meshwork and / or the scleral venous sinus. When forming a channel in the tissue, the orientation and positioning of the delivery tip are critical because achieving a transverse placement of the channel in the meshwork relative to the scleral venous sinus provides optimal drainage. Arranging the laser probe in a position transverse to the scleral venous sinus provides an improved perforation and thus improved fluid drainage by providing a larger surface area for photoablation of the laser, thereby providing optimal results.

[0400] Enhanced Fiber Probe for ELT

[0401] Patients with glaucoma experience vision loss due to the accumulation of fluid in the anterior chamber of the eye. The fluid accumulation increases the pressure in the eye and causes damage to the optic nerve. If left untreated, the damage to the optic nerve can lead to blindness.

[0402] Traditional prescription drugs for treating glaucoma do not provide a permanent solution, but rather manage the condition by reducing the pressure in the eye. For example, some drugs reduce the production of fluid, while other drugs increase the drainage of fluid. Traditional surgical treatments are also used to reduce pressure, for example, by inserting an implant into the eye to increase drainage. However, these surgeries have risks associated with them, such as displacement of the implant.

[0403] Various embodiments provide systems and methods for treating glaucoma using an optical fiber probe having a programmable number of laser pulses for use during an excimer laser trabeculostomy (ELT) procedure. ELT is a minimally invasive method for treating glaucoma that does not involve an implant. Instead, an excimer laser is used to permanently perforate the drainage system in the eye to increase fluid drainage. An ELT instrument requires an optical fiber probe to deliver laser pulses to the eye. In various embodiments, the optical fiber probe connected to the ELT instrument is programmable to deliver a variable number of laser pulses and monitor the number of pulses delivered by the probe, thereby allowing for personalized treatment of glaucoma.

[0404] Existing optical fiber probes are operable for a fixed number of laser pulses. Typically, each existing fixed-use optical fiber probe delivers a maximum number of laser pulses. If a doctor needs more than 10 laser pulses for treatment, the ELT procedure is interrupted in order to replace one fixed-use optical fiber probe with another fixed-use optical fiber probe.

[0405] Because the ELT procedure typically requires more than a standard number of laser emissions to treat glaucoma, various embodiments provide a programmable optical fiber probe to increase the maximum number of laser emissions per probe. By programming the optical fiber probe, interruptions during the ELT procedure are avoided, such as delays caused by replacing a used-up fixed-use optical fiber probe with a new fixed-use optical fiber probe in order to continue treating the eye. Thus, various embodiments avoid interruptions to the surgical procedure in order to allow for a change of device.

[0406] The methods and systems of various embodiments allow for programming of the optical fiber probe to deliver a variable number of laser pulses and monitor the number of pulses delivered by the probe. In various embodiments, the optical fiber probe can be programmed once it is connected to the ELT instrument. The ELT instrument includes an interactive user interface or display panel communicatively coupled to a controller and a processor. Settings input by the user into the interactive user interface are processed and implemented.

[0407] In an example, a physician uses an interactive user interface to input a variable number of values for laser pulses deliverable by a probe. The variable number of values for the laser pulses is programmable within a range and adjustable from a minimum amount to a maximum amount. For safety purposes, a manufacturer can set a predefined limit on the maximum number of pulses. The doctor can program the variable number of deliverable laser pulses to the maximum number set by the manufacturer. The ELT instrument programs the variable number of laser pulses deliverable by the fiber optic probe and then monitors the number of laser pulses delivered by the fiber optic probe. Thus, various embodiments provide personalized glaucoma treatment, which has the benefit of preventing reuse of medical devices and avoids the detriment of not treating the patient in an optimal manner.

[0408] In some examples, the variable number of deliverable laser emissions is determined based on a preoperative analysis performed by the physician. For example, the doctor can examine the condition of glaucoma in a subject and decide to administer 15 laser pulses per eye using ELT treatment. The physician can then program the fiber optic probe accordingly and perform the ELT procedure to deliver as many laser pulses as programmed without interrupting the treatment to replace the fiber optic probe. Thus, the various embodiments described herein provide personalized laser surgical intervention, which improves the efficiency of the ELT procedure and avoids delays in replacing the fiber optic probe.

[0409] During the ELT procedure, after programming the fiber optic probe, the physician guides the delivery tip of the fiber optic probe through a corneal incision in the eye and towards the trabecular meshwork. In some examples, the various embodiments also include administering an anesthetic to the subject prior to making the incision and inserting the probe. Typically, the incision has a length of about 1 / 8 inch or less. In some examples, one or more sutures are used to close the incision after ELT treatment. The delivery tip is guided by the physician to a position transverse to the scleral venous sinus to create permanent perforations in the trabecular meshwork and / or the scleral venous sinus. Once the perforations are created in the meshwork and / or the scleral venous sinus by the laser, the fluid drainage from the anterior chamber of the eye is immediately improved. The perforations also increase blood flow and reduce the pressure in the eye. In some cases, the doctor uses a gonioscope, an endoscope, or other light source to assist in positioning the delivery tip of the fiber optic probe.

[0410] Once the delivery tip is in a position transverse to the scleral venous sinus, a series of laser energy pulses are delivered to the trabecular meshwork. By providing the laser probe at a location transverse or crossing the scleral venous sinus, the energy from the laser is delivered to a larger surface area than if the fiber optic probe were in a position parallel or perpendicular to the scleral venous sinus. The arrangement of the delivery tip in a position transverse to the scleral venous sinus enables optimal photoablation and the formation of perforations for drainage.

[0411] To improve the drainage of aqueous humor from the anterior chamber of the eye, multiple permanent perforations are laser cut in the trabecular meshwork and / or the canal of Schlemm by an ELT procedure. Each ELT perforation has a diameter of approximately 200 μm, which is determined by the size of the delivery tip. These sizes can be modified to increase or decrease the ELT perforation diameter. In existing fiber optic probes for ELT procedures, the fiber optic probe is set to deliver a maximum fixed number of laser pulses. For example, the maximum fixed number can be 10 laser pulses. Various embodiments allow a physician to program the number of laser pulses that can be delivered by the fiber optic probe, thereby providing a variable number of deliverable laser pulses to the fiber optic probe. The number of laser pulses is programmable within a range and can be adjusted from a minimum amount to a maximum amount. According to various embodiments, a physician can attach the fiber optic probe to an ELT instrument and use an interactive user interface on the instrument to enter a range of the number of emissions that can be delivered by the attached fiber optic probe. In some examples, the number of deliverable laser pulses is a variable number. In some examples, the variable number of deliverable emissions is greater than about 10 pulses.

[0412] In one example, after examining a subject with glaucoma, the physician determines that 15 pulses are required for treatment in each eye. Using various embodiments, the physician programs the fiber optic probe to deliver 15 laser pulses as the maximum number within the range of laser emissions that the probe can deliver. In this case, the physician uses the fiber optic probe that is programmed to deliver 15 laser pulses to treat glaucoma in the first eye of the subject. For sterilization purposes, a second fiber is programmed and used to deliver 15 laser pulses in the second eye of the subject. The physician uses two fiber optic probes during the ELT procedure, one probe for each eye. In contrast, if the physician uses a conventional fiber optic probe with a fixed number, where 10 pulses are set as the maximum fixed number of pulses, then twice the number of fiber optic probes would be used for the same ELT treatment plan. The first fixed number probe would be used to apply up to 10 pulses to the first eye, the first fixed number probe would be replaced with a second fixed number probe, and the remaining 5 pulses in the treatment plan would be applied to the first eye. The process would be repeated to treat the second eye of the subject, where a third fixed number probe would be used to apply up to 10 pulses to the second eye, and a fourth fixed number probe would be used to apply the remaining 5 pulses in the treatment plan to the second eye.

[0413] In one embodiment, the input options on the interactive user interface relate to setting the pulse, width, and amplitude of the laser. Due to safety considerations, the maximum settings for each of the pulse, width, and amplitude are typically predefined by the manufacturer. The user can select values within the predefined ranges set by the manufacturer.

[0414] Various embodiments use a 308 nm xenon chloride ultraviolet excimer laser. Compared with visible light or infrared lasers, the 308 nm xenon chloride ultraviolet excimer laser causes minimal thermal damage. In some examples, the excimer laser is a sealed xenon chloride (XeCl) excimer laser, such as the EX TRA laser manufactured by MLase AG. Since ELT is a non-thermal procedure, tissue reactions in the trabecular meshwork are not shown or activated postoperatively. The lack of heat generation in ELT allows for little activation of postoperative tissue reactions and provides long-term stability of the decompression effect.

[0415] In addition, to avoid corneal absorption of the laser radiation, an optical fiber is used to deliver the energy. The delivery tip of the optical fiber probe includes an optical fiber jacketed in a metal, such as stainless steel. In some examples, the delivery tip is angled (e.g., 0°, 15°, 30°, and 45° relative to the tip). The optical fiber probe includes an optical fiber suitable for UV light embedded in a handheld laser applicator. In some examples, the FIDO laser applicator manufactured by MLase AG is used as the optical fiber probe.

[0416] The systems and methods of various embodiments herein use excimer laser trabeculostomy (ELT) to treat glaucoma. To create holes or perforations in the trabecular meshwork and / or Schlemm's canal, multiple pulses are administered to the patient from an excimer laser. ELT converts trabecular meshwork tissue into gas by photoablation. By permanently perforating Schlemm's canal and / or the trabecular meshwork, the fluid accumulated in the eye is immediately allowed to drain. In addition, since the perforations allow for increased blood flow and fluid drainage, subsequent vision loss due to optic nerve damage caused by any accumulation is avoided.

[0417] In existing optical fiber probes for the ELT procedure, the optical fiber probe is set to deliver a maximum fixed number of laser pulses. Various embodiments allow a physician to program the number of laser pulses that can be delivered by the optical fiber probe, thus providing an optical fiber probe that can deliver a variable number of laser pulses. Once the delivery tip is in a position transverse to Schlemm's canal, the physician applies pulsed photoablation energy to create an ELT site or perforation in the trabecular meshwork and / or Schlemm's canal. In some examples, the physician creates more than about 10 ELT sites per eye.

[0418] Figure 52 A flowchart of embodiment 9100 is shown. Various embodiments relate to treating a patient with glaucoma using ELT. In various embodiments, energy pulses delivered from an excimer laser are at a position transverse to Schlemm's canal. In some examples, the method includes a preoperative analysis 9110, such as a diagnosis of the eye disease, an examination and / or visualization of the anterior chamber of the eye to assist in placing the laser probe, and an analysis of the number of laser pulses required for treatment. In various embodiments, excimer laser trabeculostomy (ELT) is used to treat glaucoma.

[0419] The methods of various embodiments include 9120 programming the number of emissions that can be delivered by an optical fiber probe. In existing optical fiber probes for ELT procedures, the optical fiber probe is set to deliver a maximum fixed number of laser pulses. The methods and systems of various embodiments allow a physician to program the number of laser pulses that can be delivered by the optical fiber probe. The number of laser pulses is programmable within a certain range and can be adjusted from a minimum amount to a maximum amount. The physician can attach the optical fiber probe to the ELT instrument and use the interactive user interface on the instrument and then use the controller and processor of the ELT system to program the optical fiber probe to deliver a range of laser pulses.

[0420] Some embodiments of the method include 9130 administering anesthesia to the patient. Topical anesthesia is typically employed, usually by instilling a topical anesthetic such as tetracaine or lidocaine. Lidocaine and / or a longer-acting bupivacaine anesthetic can be injected into the area around (peribulbar block) or behind (retrobulbar block) the eye muscle cone to more fully immobilize the extraocular muscles and minimize pain sensation. Optionally, a facial nerve block using lidocaine and bupivacaine can be used to reduce eyelid squeezing. In some cases, such as for children, patients with traumatic eye injuries, and nervous or uncooperative patients and animals, general anesthesia is administered under cardiovascular monitoring. To prepare the surgical area, appropriate aseptic precautions must be taken, including the use of an antimicrobial agent such as povidone iodine and the use of sterile drapes, gowns, and gloves. In some cases, an eyelid retractor is inserted to keep the eyelids open.

[0421] The methods of various embodiments further include the physician 9140 making a small incision in the patient's eye. Prior to performing the ELT procedure, a small incision is made in the cornea of the eye to allow the introduction of the laser probe. Typically, the incision is about 1 / 8 inch or smaller. During the ELT surgery, the physician guides the delivery tip of the optical fiber probe through the corneal incision in the eye and towards the trabecular meshwork. The delivery tip is guided by the physician to a position transverse to the scleral venous sinus. The physician can use a goniolens, an endoscope, and / or a light source to assist in positioning the delivery tip. By providing the laser probe at a position transverse to or crossing the scleral venous sinus, compared to a position where the laser is parallel or perpendicular to the scleral venous sinus, the laser is delivered to a larger surface area. Thus, the arrangement of the delivery tip at a position transverse to the scleral venous sinus achieves optimal photoablation and the formation of perforations in the meshwork and / or the scleral venous sinus. When creating a perforation in the tissue, the orientation and positioning of the delivery tip are critical because achieving a transverse placement of the perforation in the meshwork relative to the scleral venous sinus provides optimal drainage.

[0422] Once the delivery tip is in a position transverse to the trabecular meshwork, physician 9150 applies ELT treatment to the patient by delivering a series of laser energy pulses to the trabecular meshwork and the trabecular meshwork. The physician applies pulsed photoablation energy to create an ELT site or perforation in the trabecular meshwork and / or the trabecular meshwork. Unlike conventional fiber optic probes with a maximum fixed number of deliverable laser pulses, the methods of various embodiments allow the physician to program the number of pulses deliverable by the fiber optic probe. According to the methods and systems of various embodiments, the number of laser pulses deliverable by the fiber optic probe can be programmed within a range and adjusted from a minimum amount to a maximum amount.

[0423] In some examples, the physician uses a programmed fiber optic probe to create more than about 10 ELT sites in the patient's eye. A small amount of blood reflux from the trabecular meshwork confirms each opening. The fiber optic probe is removed from the eye. Notably, the IOP decreases immediately after the ELT procedure is administered.

[0424] After applying ELT treatment, physician 9160 closes the incision. Typically, the physician uses sutures to close the incision. Some physicians place sutures in the incision, and other physicians reserve sutures for use in the event of persistent leakage.

[0425] The methods of various embodiments include 9170 analyzing postoperative results and 9180 reporting the results and / or scheduling a postoperative follow-up appointment with the patient. For example, the physician's analysis may include observing a small amount of blood reflux from the trabecular meshwork to confirm each opening. By observing the blood reflux and drainage of aqueous humor, the physician can immediately verify the effectiveness of the laser treatment. In turn, the physician can report the results to the patient, prescribe postoperative medications such as topical antibiotics and steroid drops, and schedule a follow-up postoperative appointment for the patient. For example, the patient uses topical antibiotics and steroid drops for 1 to 2 weeks after surgery.

[0426] Figure 53 An interactive user interface 9410 according to various embodiments is shown (e.g., Figure 4 , Figure 21, Figure 32 , Figure 45 's 416, Figure 41 's 6310, etc.). The interactive user interface 9410 is an interactive display screen on the ELT instrument. The interactive user interface 9410 is communicatively coupled to a controller, which allows a user (e.g., a physician) to view and change settings using the interactive user interface 9410, such as via haptic feedback and / or touchscreen technology. The interactive user interface displays various information and settings, such as patient information, instrument information, and instrument settings.

[0427] Display different information on multiple interchangeable display screens. For example, one screen can display the setup information of the fiber optic probe, such as Figure 53 shown, while another screen displays patient information. The user can view different screens by using button 9425 to return to the previous screen or button 9427 to move forward to the next screen. In Figure 53 the embodiment shown, a setup screen 9411 for the fiber optic probe is shown. Display box 9413 specifies the setting, which is the maximum number of laser pulses of the fiber optic probe. Display box 9415 shows the maximum number of laser pulses that the user has entered. To change the set maximum number of laser pulses, the user can select button 9417 to increase the number in box 9415 and select button 9419 to decrease the number in box 9415. Display box 9421 indicates the number of laser pulses that have been emitted from the probe, and the changing number is shown in box 9423. Figure 53 The embodiment shown in

[0428] indicates that the fiber optic probe has been programmed to deliver 12 pulses as the maximum number of laser pulses, and so far, the fiber optic probe has delivered 8 laser pulses. In one embodiment, the input options on the display screen relate to setting the pulse, width, and amplitude of the laser. Due to safety considerations, the manufacturer can predefine the maximum settings for each of the pulse, width, and amplitude. The user can select values within the predefined range set by the manufacturer.

[0429] Incorporated by reference

[0430] Throughout this disclosure, other documents have been referenced and cited, such as patents, patent applications, patent publications, journals, books, papers, web content. For all purposes, all of these documents are incorporated herein by reference in their entirety.

[0431] Equivalents

[0432] In addition to those shown and described herein, various modifications of the various embodiments described herein and many further embodiments will be apparent to those skilled in the art from the entire content herein (including the references to scientific and patent literature cited herein). The subject matter herein contains important information, examples, and guidance that can be applied to the practice of various embodiments and their equivalents.

Claims

1. A method for treating a patient suffering from an eye disease, the method comprising: During preoperative analysis of the patient, it is determined that the patient is at risk of developing glaucoma; and Based on the preoperative analysis finding that the patient is at risk of developing glaucoma, the patient is treated with an excimer laser to prophylactically treat glaucoma.

2. The method according to claim 1, wherein during the pre-operative analysis, the patient is diagnosed with cataracts and has a risk of developing glaucoma.

3. The method according to claim 1, wherein the application of excimer laser energy for prophylactic treatment of glaucoma occurs when the patient is not diagnosed with glaucoma.

4. The method according to claim 1, wherein the application of excimer laser energy for prophylactic treatment of glaucoma occurs before an elevated intraocular pressure (IOP) is identified in the patient's eye.

5. The method according to claim 1, wherein the application of excimer laser energy for prophylactic treatment of glaucoma occurs when the patient does not actually have glaucoma.

6. The method according to claim 1, wherein the risk is a congenital risk.

7. The method according to claim 6, wherein the congenital risk is related to the patient's family history, race, gender, or a combination thereof.

8. The method according to claim 1, wherein the risk is an existing comorbidity.

9. The method according to claim 1, wherein the existing comorbidity includes elevated intraocular pressure, obesity, diabetes, angle-closure glaucoma, smoking, alcohol consumption, or a combination thereof.

10. The method according to claim 1, wherein the risk is an age-related risk.

11. The method according to claim 10, wherein the age-related risk includes being equal to or older than 40 years old, equal to or older than 45 years old, equal to or older than 50 years old, equal to or older than 55 years old, equal to or older than 60 years old, equal to or older than 65 years old, equal to or older than 70 years old, equal to or older than 75 years old, or equal to or older than 80 years old.

12. The method according to claim 1, further comprising: During preoperative analysis of the patient, it is determined that the patient has a cataract; and Phacoemulsification ultrasound is applied to a patient diagnosed with a cataract.

13. The method according to claim 12, wherein the phacoemulsification ultrasound and the treatment of the patient with an excimer laser for prophylactic treatment of glaucoma are performed in the same surgical procedure on the patient.

14. The method according to claim 12, wherein the phacoemulsification ultrasound and treating the patient with an excimer laser for prophylactic treatment of glaucoma are applied through the same incision in the patient's eye.

15. The method according to claim 1, further comprising administering an anesthetic to the patient before applying the phacoemulsification ultrasound and the excimer laser.

16. The method according to claim 1, wherein treating the patient with the excimer laser comprises applying pulses of pulsed energy from the excimer laser.

17. A method of treating a patient having an eye disease, the method comprising: During preoperative analysis of the patient, it is determined that the patient is at risk of developing glaucoma; Phacoemulsification ultrasound is applied to the patient through an incision in the patient's eye, and the patient has been diagnosed with a cataract in the eye; and Based on the preoperative analysis finding that the patient is at risk of developing glaucoma, excimer laser energy is applied through the incision in the eye to prophylactically treat glaucoma.

18. The method according to claim 17, wherein the risk is a congenital risk associated with the patient's family history, race, gender, or a combination thereof.

19. The method according to claim 17, wherein the risk is an age-related risk or an existing comorbidity.

20. An apparatus for delivering laser energy to the surface of the trabecular meshwork of an eye, comprising: An excimer laser source; A probe configured to be connected to the excimer laser source; and A delivery tip connected to the probe, wherein the probe is configured to: Be inserted into the eye of a subject not suffering from glaucoma, wherein during preoperative analysis of the subject, it has been determined that the subject is at risk of developing glaucoma; and Deliver emissions from the excimer laser source to create perforations in the trabecular meshwork.

21. A method of treating a patient having an eye disease, the method comprising: It is determined that the patient has angle-closure glaucoma or narrow-angle glaucoma; During a surgical procedure performed on the patient, the angle-closure glaucoma or narrow-angle glaucoma is treated; and During the surgical procedure, the patient is treated with an excimer laser to create multiple perforations in the trabecular meshwork by applying multiple pulses from the excimer laser to the trabecular meshwork.

22. The method according to claim 21, wherein treating the angle-closure glaucoma or narrow-angle glaucoma comprises applying phacoemulsification ultrasound to the patient.

23. The method according to claim 22, wherein the phacoemulsification ultrasound comprises fragmenting the lens of the eye.

24. The method according to claim 23, further comprising: After fragmenting the lens, the lens is removed from the patient's eye.

25. The method according to claim 24, further comprising: After removing the lens, the lens of the eye is replaced with an artificial lens.

26. The method according to claim 25, wherein the intraocular lens is thinner than the lens of the eye removed from the eye.

27. The method according to claim 26, wherein the intraocular lens provides a passage for fluid drainage between the intraocular lens and the iris of the eye.

28. The method according to claim 21, wherein the angle-closure glaucoma or narrow-angle glaucoma results in at least partial obstruction of fluid flow through the trabecular meshwork from the anterior chamber of the eye located between the cornea of the eye and the lens of the eye due to the protrusion of the iris of the eye.

29. The method according to claim 28, wherein the treatment of the angle-closure glaucoma or narrow-angle glaucoma results in a reduction in iris protrusion.

30. The method according to claim 29, wherein treating the patient with an excimer laser occurs after the reduction in iris protrusion.

31. The method according to claim 21, wherein treating the patient with an excimer laser includes inserting an excimer laser probe into an incision in the patient's eye.

32. The method according to claim 31, wherein treating the angle-closure glaucoma or narrow-angle glaucoma includes inserting a phacoemulsification ultrasound probe into an incision in the patient's eye.

33. The method according to claim 32, wherein the incision has a length of about one-eighth of an inch or less.

34. The method according to claim 21, wherein the multiple pulses include at least ten pulses.

35. The method according to claim 21, further comprising administering an anesthetic to the patient before treating the angle-closure glaucoma or narrow-angle glaucoma and before treating the patient with an excimer laser.

36. The method according to claim 21, wherein the excimer laser includes a xenon chloride laser source.

37. A method of treating a patient suffering from an eye disease, the method comprising: It is determined that the patient has angle-closure glaucoma or narrow-angle glaucoma; During a surgical procedure performed on the patient, phacoemulsification ultrasound is applied to the patient to treat the angle-closure glaucoma or narrow-angle glaucoma, wherein the phacoemulsification ultrasound is applied via a phacoemulsification probe inserted through an incision in the patient's eye; and During the surgical procedure, the patient is treated with an excimer laser to create multiple perforations in the trabecular meshwork by applying multiple pulses from the excimer laser to the trabecular meshwork, wherein the multiple pulses are applied via an excimer laser probe inserted through the incision.

38. The method according to claim 37, wherein the phacoemulsification ultrasound includes fragmenting the lens of the eye.

39. The method according to claim 37, wherein treating the patient with an excimer laser occurs after applying the phacoemulsification ultrasound.

40. A device for delivering laser energy to the surface of the trabecular meshwork of an eye, comprising: An excimer laser source; A probe configured to be connected to the excimer laser source; and A delivery tip connected to the probe, wherein the probe is configured to: Be inserted into the eye of a subject with angle-closure glaucoma or narrow-angle glaucoma, wherein the probe is configured to be inserted into the eye after treatment of the angle-closure glaucoma or narrow-angle glaucoma is performed on the subject; and Deliver emissions from the excimer laser source to create perforations in the trabecular meshwork.

41. An apparatus for treating an eye, comprising: A housing; An excimer laser source within the housing; An ultrasonic generator located within the housing; A flushing source within the housing; and A suction source within the housing.

42. The apparatus according to claim 41, wherein, The housing is a single housing.

43. The apparatus according to claim 41, further comprising wheels attached to the housing such that the apparatus is movable.

44. The apparatus according to claim 41, further comprising two foot pedals or the housing, the housing including two sockets, each socket being configured to receive a connector for a foot pedal.

45. The apparatus according to claim 44, wherein the excimer laser source can be controlled using a first one of the two foot pedals.

46. The apparatus according to claim 45, wherein, At least one of the ultrasonic generator, the irrigation source, or the aspiration source can be controlled using the second foot pedal of the two foot pedals.

47. The apparatus according to claim 41, further comprising a single power cord connected to the housing and connectable to a wall outlet.

48. The apparatus according to claim 47, wherein each of the excimer laser source, the ultrasonic generator, the irrigation source, and the aspiration source is powered via the single power cord.

49. The apparatus according to claim 41, further comprising a port for connecting an excimer laser probe to the housing.

50. The apparatus according to claim 49, wherein the port is a first port, and wherein the apparatus further comprises a second port for connecting a phacoemulsification probe to the housing.

51. The apparatus according to claim 50, wherein the ultrasonic generator, the irrigation source, and the aspiration source are configured together for use with the phacoemulsification probe to perform phacoemulsification ultrasound on a subject's eye.

52. The apparatus according to claim 51, wherein, The excimer laser source is configured to be used with the excimer laser probe to perform an excimer laser trabeculostomy (ELT) procedure on the eye of the subject.

53. The device according to claim 41, further comprising a display on the housing.

54. The device according to claim 41, further comprising an energy monitoring port on the housing.

55. The device according to claim 54, wherein the energy monitor port is configured to receive a first distal end of a phacoemulsification probe and is configured to receive a second distal end of an excimer laser probe.

56. The device according to claim 55, further comprising a sensor in the energy monitor port, the sensor being 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 excimer laser probe, respectively.

57. A device for treating an eye, comprising: A housing; An excimer laser source within the housing, the excimer laser source being configured to perform excimer laser trabeculostomy (ELT); and A component configured to perform phacoemulsification ultrasound, the component comprising: An ultrasonic generator located within the housing; An irrigation source located within the housing; and An aspiration source within the housing.

58. The device according to claim 57, further comprising a single power cord connected to the housing and connectable to a wall socket.

59. The device according to claim 57, wherein Further comprising a first port for connecting the excimer laser probe to the housing and a second port for connecting the phacoemulsification probe to the housing.

60. A method for treating an eye, comprising: Performing excimer laser trabeculostomy (ELT) using an excimer laser source housed in a single housing; and Performing phacoemulsification ultrasound with a component housed in the single housing, the component comprising: An ultrasonic generator located within the housing; An irrigation source located within the housing; and An aspiration source within the housing.

61. A method of delivering laser energy to the surface of the trabecular meshwork of an eye, comprising: Inserting a probe into the eye; Delivering pulses of the laser energy at a plurality of locations along the trabecular meshwork via the probe to create a plurality of perforations in the trabecular meshwork, wherein: The plurality of perforations form a line or curve transverse to the sinus venosus sclerae in the eye.

62. The method according to claim 61, wherein the laser energy is delivered from an excimer laser source.

63. The method according to claim 61, wherein the plurality of perforations are created in the trabecular meshwork to treat glaucoma.

64. The method according to claim 61, wherein at least one of the plurality of perforations in the trabecular meshwork is not aligned with the scleral venous sinus.

65. The method according to claim 61, wherein at least one of the plurality of perforations in the trabecular meshwork does not create a fluid connection between the scleral venous sinus and the anterior chamber of the eye located between the cornea of the eye and the lens of the eye.

66. The method according to claim 61, wherein at least one of the plurality of perforations in the trabecular meshwork is aligned with the scleral venous sinus.

67. The method according to claim 61, wherein at least one of the plurality of perforations in the trabecular meshwork forms a fluid connection between the scleral venous sinus and the anterior chamber of the eye located between the cornea of the eye and the lens of the eye.

68. The method according to claim 61, wherein a light source including a gonioscope, an endoscope, or other light source facilitates adjustment of the placement of the probe.

69. The method according to claim 61, wherein, The plurality of pulses includes 10 pulses per eye.

70. The method according to claim 61, wherein, The plurality of pulses includes more than 10 pulses per eye.

71. The method according to claim 61, wherein each of the plurality of perforations has a diameter of about 200 μm.

72. The method according to claim 61, wherein the probe is inserted into an incision in the eye.

73. The method according to claim 61, further comprising analyzing the effectiveness of the pulse by visualizing the drainage of aqueous humor and the reflux of blood.

74. The method according to claim 61, wherein the probe is an optical fiber probe.

75. The method according to claim 61, wherein the laser energy is delivered from an excimer laser source including a xenon chloride laser.

76. The method according to claim 61, further comprising physically contacting the trabecular meshwork with the probe while delivering the plurality of pulses, wherein, Generating the plurality of perforations while the probe is in physical contact with the trabecular meshwork.

77. A method of delivering laser energy to the surface of the trabecular meshwork of an eye, comprising: Inserting a probe into the eye of a subject with glaucoma; Adjusting the placement of the probe to a first position close to the trabecular meshwork in the eye; Delivering a first emission from the laser source to form a first perforation in the trabecular meshwork; Adjusting the placement of the probe to a second position close to the trabecular meshwork; and Delivering a second pulse from the laser source to form a second perforation in the trabecular meshwork, wherein the first perforation and the second perforation form a line extending transverse to the sinus venosus sclerae of the eye.

78. The method according to claim 77, further comprising adjusting the placement of the probe to a subsequent position closer to the trabecular meshwork and delivering a subsequent pulse from the laser source to create a subsequent perforation in the trabecular meshwork, wherein the first perforation, the second perforation, and the subsequent perforation form a line or curve extending transversely to the sinus venosus sclerae of the eye.

79. The method according to claim 77, wherein the laser source comprises an excimer laser source.

80. An apparatus for delivering laser energy to the surface of the trabecular meshwork of an eye to treat glaucoma, comprising: An excimer laser source; A probe configured to be connected to the excimer laser source; and A delivery tip connected to the probe, wherein the probe is configured to: Insert into the eye of a subject with glaucoma; Move to a first position close to the trabecular meshwork in the eye; Deliver a first emission from the excimer laser source to create a first perforation in the trabecular meshwork; Move to a second position close to the trabecular meshwork; and Deliver a second emission from the excimer laser source to form a second perforation in the trabecular meshwork, wherein the first perforation and the second perforation form a line extending transverse to the sinus venosus sclerae of the eye.

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