Systems and methods for laser treatment of ocular tissue using non-collinear imaging

Abstract

A method for treating an eye includes transmitting an OCT beam along an OCT optical path that enters a first optical subsystem along an input axis and exits the first optical subsystem along an output axis, the output axis being 1) substantially parallel to an optical axis of the eye, 2) radially offset from the optical axis of the eye, and 3) extending through the cornea into a portion of the iridocorneal angle at a point along a circumferential angle of the eye. The method also includes imaging the portion of the iridocorneal angle with the OCT beam, and transmitting a laser beam along an angled optical path that extends through the first optical subsystem, through the cornea, and through the anterior chamber into a target volume of ocular tissue at the portion of the iridocorneal angle, and photodisrupting at least a portion of the target volume of ocular tissue with the laser beam.

Description

[Technical Field]

[0001]

[0001] The present disclosure relates generally to the field of medical devices and the treatment of ophthalmic diseases, including glaucoma, and more particularly to systems and methods for laser treatment with non-collinear imaging. [Background technology]

[0002] Before describing the various types of glaucoma and current diagnostic and treatment options, a brief overview of the anatomy of the eye will be provided.

[0003]

[0003] Anatomy of the eye

[0004] Referring to Figures 1-3, the outer tissue layers of eye 1 include the sclera 2, which provides the structure and shape of the eye. In front of the sclera 2 is the cornea 3, which is composed of a transparent tissue layer that allows light to enter the interior of the eye. Inside eye 1 is the lens 4, which is connected to the eye by fibrous zonules 5, which are connected to the ciliary body 6. Between the lens 4 and the cornea 3 is the anterior chamber 7, which contains a flowing, clear fluid called aqueous humor 8. Surrounding the periphery of the lens 4 is the iris 9, which forms the pupil around approximately the center of the lens. As shown in Figure 2, the posterior chamber 23 is an annular space behind the iris 9 and is surrounded by the ciliary body 6, fibrous zonules 5, and lens 4. The vitreous body 10 is located between the lens 4 and the retina 11. Light entering the eye is optically focused through the cornea 3 and lens.

[0004]

[0005] Referring to FIG. 2 , the sclerocorneal junction of the eye is the portion of the anterior chamber 7 at the intersection of the iris 9, sclera 2, and cornea 3. Anatomical structures at the sclerocorneal junction of the eye 1 include the trabecular meshwork 12, a fibrous network of tissue that surrounds the iris 9 within the eye 1. Briefly, in general terms, the tissues at the sclerocorneal junction are arranged as follows: the iris 9 is in contact with the ciliary body 6, which is in contact with the underside of the scleral spur 14, the top of which serves as an attachment point to the bottom of the trabecular meshwork 12. The ciliary body 6 resides primarily in the posterior chamber but extends to the corners of the anterior chamber 7. The network of tissue layers that make up the trabecular meshwork 12 is porous, providing a drainage pathway for aqueous humor 8 flowing from the anterior chamber 7. This pathway is sometimes referred to herein as the aqueous humor outflow pathway, aqueous outflow pathway, or simply the outflow pathway.

[0005]

[0006] Referring to FIG. 3, the pathways formed by the openings in the trabecular meshwork 12 connect the uvea 15, the corneoscleral meshwork 16, and a series of thin, porous tissue layers called the paracanalicular tissue 17. The paracanalicular tissue 17 is adjacent to a structure called Schlemm's canal 18. Schlemm's canal 18 carries a mixture of aqueous humor 8 and blood from surrounding tissues and drains it into the venous system through a system of collecting ducts 19. As shown in FIG. 2, the vascular layer of the eye, called the choroid 20, lies next to the sclera 2. A space called the suprachoroidal space 21 may exist between the choroid 20 and the sclera 2. The circumferentially extending area near the wedge-shaped periphery between the cornea 3 and the iris 9 is called the iridocorneal angle 13. The iridocorneal angle 13 is also called the corneal angle of the eye or simply the angle of the eye. All of the ocular tissues shown in FIG. 3 are considered to be within the iridocorneal angle 13.

[0006]

[0007] With reference to FIG. 4 , two possible outflow pathways for the movement of aqueous humor 8 include a trabecular outflow pathway 40 and a uveoscleral outflow pathway 42. Still referring to FIG. 2 , aqueous humor 8 produced by the ciliary body 6 flows from the posterior chamber 23 through the pupil into the anterior chamber 7 and then exits the eye through one or more of two different outflow pathways 40, 42. Approximately 90% of the aqueous humor 8 passes through the trabecular meshwork 12 into Schlemm's canal 18, passes through one or more collecting plexuses 19, and exits the trabecular outflow pathway 40 before being drained into the venous system via drainage pathway 41. The remaining aqueous humor 8 exits primarily through the uveoscleral outflow pathway 42, which passes through the surface of the ciliary body 6 and the iris root into the suprachoroidal space 21 (see FIG. 2 ). The aqueous humor 8 exits the suprachoroidal space 21 and from there through the sclera 2.

[0007]

[0008] The intraocular pressure of the eye is determined by the outflow of aqueous humor 8 through the trabecular outflow pathway 40 and the resistance to aqueous humor outflow through the trabecular outflow pathway. The intraocular pressure of the eye is largely independent of the outflow of aqueous humor 8 through the uveoscleral outflow pathway 42. Resistance to the outflow of aqueous humor 8 through the trabecular outflow pathway 40 can lead to elevated intraocular pressure, which is a widely recognized risk factor for glaucoma. Collapse or dysfunction of Schlemm's canal 18 and trabecular meshwork 12 can increase resistance through the trabecular outflow pathway 40.

[0008]

[0009] Referring to FIG. 5, as an optical system, the eye 1 is represented by an optical model described by idealized central and rotational symmetry planes, entrance and exit pupils, and six cardinal points (foci in object and image space, first and second principal planes, and first and second nodal points). Angular directions relative to the human eye are often defined relative to the optical axis 24, visual axis 26, pupillary axis 28, and line of sight 29 of the eye. The optical axis 24 is an axis of symmetry, a line connecting the vertices of the ideal surface of the eye. The visual axis 26 connects the foveal center 22 with the first and second nodal points to the object. The line of sight 29 connects the fovea to the object via the exit and entrance pupils. The pupillary axis 28 is perpendicular to the anterior surface of the cornea 3 and is directed toward the center of the entrance pupil. These ocular axes differ from each other by only a few degrees and fall within a range commonly referred to as the line of sight.

[0009]

[0010] glaucoma

[0011] Glaucoma is a group of diseases that can damage the optic nerve, causing vision loss and blindness. It is the leading cause of irreversible blindness. Approximately 80 million people worldwide are estimated to have glaucoma, of which approximately 6.7 million are blind in both eyes. More than 2.7 million Americans over the age of 40 have glaucoma. Symptoms begin with loss of peripheral vision and can progress to blindness.

[0010]

[0012] There are two forms of glaucoma: angle-closure glaucoma and open-angle glaucoma. Referring to Figures 1-4, in angle-closure glaucoma, the sunken iris 9 in the anterior chamber 7 can obstruct and block the flow of aqueous humor 8. In open-angle glaucoma, a more common form of glaucoma, the permeability of ocular tissue can be affected by irregularities in the inner walls of the proximal canalicular tissue 17 and Schlemm's canal 18a, and by obstruction of tissue in the iridocorneal angle 13 along the trabecular outflow pathway 40.

[0011]

[0013] As mentioned above, elevated intraocular pressure (IOP) damages the optic nerve and is widely recognized as a risk factor for glaucoma. However, not everyone with elevated IOP develops glaucoma, and glaucoma can occur even without elevated IOP. Nevertheless, reducing IOP is desirable to reduce the risk of glaucoma.

[0012]

[0014] Methods for diagnosing the eye condition in patients with glaucoma include visual acuity and visual field testing, mydriasis, tonometry (measuring intraocular pressure), and pachymetry (measuring corneal thickness). Vision loss begins with a narrowing of the visual field and progresses to complete blindness. Imaging methods include slit-lamp examination, gonioscopy to examine the iridocorneal angle, and optical coherence tomography (OCT) imaging of the anterior chamber and retina.

[0013]

[0015] Once diagnosed, there are several clinically proven treatments to control or reduce intraocular pressure and slow or stop the progression of glaucoma. The most common treatments are: 1) medications, such as eye drops or tablets; 2) laser surgery; and 3) traditional surgery. Treatment usually begins with medication. However, patient non-compliance often hinders the effectiveness of medications. If medications do not work for a patient, laser surgery is usually the next treatment tried. Traditional surgery is more invasive, carries higher risks than medications and laser surgery, and has a limited duration of effectiveness. Therefore, traditional surgery is usually reserved as a last resort for patients whose intraocular pressure cannot be controlled with medications or laser surgery.

[0014]

[0016] laser surgery

[0017] 2, laser surgery for glaucoma targets the trabecular meshwork 12 to reduce the flow resistance of aqueous humor 8. Common laser treatments include argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT), and excimer laser trabeculoplasty (ELT).

[0015]

[0018] ALT was the original laser trabeculoplasty. During the procedure, an argon laser with a wavelength of 514 nm is applied to the trabecular meshwork 12 approximately 180 degrees around the iridocorneal angle 13. The argon laser causes thermal interaction with the ocular tissue, creating openings in the trabecular meshwork 12. However, ALT can cause scarring of the ocular tissue, followed by an inflammatory response and tissue healing, which can ultimately close the trabecular meshwork 12 openings created by ALT treatment, thus reducing the effectiveness of the treatment. Furthermore, because of this scarring, ALT therapy usually cannot be repeated.

[0016]

[0019] SLT is designed to selectively target pigment within the trabecular meshwork 12, reducing the amount of heat transmitted to surrounding ocular tissues and thereby reducing the scarring effect. During the procedure, a 532 nm solid-state laser is applied to the trabecular meshwork 12 in a 180-360 degree range around the circumference of the iridocorneal angle 13, removing the pigment cells lining the trabecular meshwork 12. During SLT, the collagen ultrastructure of the trabecular network is preserved. 12 SLT treatments can be repeated, but subsequent treatments are less effective at lowering IOP.

[0017]

[0020] ELT utilizes a 308 nm wavelength ultraviolet (UV) excimer laser to non-thermally interact with ocular tissue to treat the trabecular meshwork 12 and the inner wall of Schlemm's canal 18a without triggering a healing response. This results in a longer-lasting effect on IOP reduction. However, because the UV light from the laser cannot penetrate deep into the eye, laser light is directed at the trabecular meshwork 12 via an optical fiber inserted into the eye 1 through an opening, bringing the laser light into contact with the trabecular meshwork. This procedure is highly invasive and is usually performed at the same time as cataract surgery when the eye has already been opened. Like ALT and SLT, ELT does not allow for controlled IOP reduction. Summary of the Invention

[0018]

[0021] The present disclosure relates to a method for imaging and treating an eye having an optical axis, a cornea, an anterior chamber, and an iridocorneal angle. The method includes transmitting an optical coherence tomography (OCT) beam of an OCT imaging device along an OCT optical path, where the OCT beam enters a first optical subsystem along an OCT input axis and exits the first optical subsystem along an OCT output axis. The OCT output axis is approximately parallel to the optical axis of the eye and radially offset from the optical axis of the eye, extending through the cornea to a portion of the iridocorneal angle at a point along a circumferential angle of the eye. The method further includes imaging a portion of the iridocorneal angle with the OCT beam; irradiating a laser beam along an angled optical path through the first optical subsystem, the cornea, the anterior chamber, and onto a target volume of ocular tissue at the portion of the iridocorneal angle; and photodisrupting at least a portion of the target volume of ocular tissue with the laser beam.

[0019]

[0022] The present invention relates to an integrated surgical system for imaging and treating an eye having an optical axis, a cornea, an anterior chamber, and an iridocorneal angle, the surgical system including a laser source configured to output a laser beam, an optical coherence tomography (OCT) imaging device configured to output an optical coherence tomography (OCT) beam, a first optical subsystem configured to couple to the eye, a second optical subsystem optically coupled to the laser source, the OCT imaging device, and the first optical subsystem, and a control system coupled to the laser source, the OCT imaging device, and the second optical subsystem.

[0020]

[0023] The first optical subsystem is configured to receive an OCT beam incident on an entry surface of the first optical subsystem along an OCT input axis and direct the OCT beam through the first optical subsystem along an OCT optical path to an OCT output axis that is 1) substantially parallel to the optical axis of the eye, 2) radially offset from the optical axis of the eye, and 3) extends through the cornea to a portion of the iridocorneal angle at a point along a circumferential angle of the eye. The first optical subsystem is also configured to receive a laser beam incident on the entry surface of the first optical subsystem along the laser input axis and direct it along an angled optical path 706 through the first optical subsystem 1001, through the cornea, and through the anterior chamber into a target volume of ocular tissue at the portion of the iridocorneal angle.

[0021]

[0024] The second optical subsystem is configured to transmit the laser beam along a laser input axis to the first optical subsystem and the OCT beam along an OCT input axis to the first optical subsystem. The control system is configured to control the OCT imaging device to output the OCT beam to the second optical subsystem and image a portion of the iridocorneal angle with the OCT beam, and to control the laser source to output the laser beam to the second optical subsystem and photodisrupt at least a portion of the target volume of ocular tissue.

[0022]

[0025] The present disclosure also relates to a focusing objective head configured to couple to a patient interface. The patient interface includes a window configured to couple to the cornea of ​​the eye. The focusing objective head includes an exit lens and a prism mechanically and optically coupled to the exit lens. The exit lens and prism together form an optical assembly mechanically secured to a housing of the focusing objective head. The exit lens is configured to optically couple to the window of the patient interface to align an axis of the exit lens with the optical axis of the eye. Referring to FIG. 13a, the optical assembly formed by the exit lens and prism is configured to receive an OCT beam incident on an entry face of the prism along an OCT input axis and direct the OCT beam to an OCT output axis. The OCT output axis is approximately parallel to and radially offset from the axis of the exit lens, and extends through the exit lens to the cornea and to a portion of the iridocorneal angle of the eye. The optical assembly formed by the exit lens and the prism is also configured to receive a laser beam incident on the entry surface of the exit lens along a laser input axis and direct the laser beam along an angled optical path through the exit lens, through the cornea, through the anterior chamber, and into a target volume of ocular tissue within the iridocorneal angle. To this end, the optical assembly formed by the exit lens and the prism includes a reflective surface arranged to direct the laser beam along the angled optical path.

[0023]

[0026] It is understood that other aspects of the apparatus and method will become apparent to those skilled in the art from the following detailed description, wherein various aspects of the apparatus and method are shown and described by way of illustration. As will be understood, these aspects may be implemented in other different forms, and their several details may be modified in various other respects. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0024]

[0027] Various aspects of systems, apparatus and methods are presented in the detailed description, by way of example and not limitation, with reference to the accompanying drawings. [Brief explanation of the drawings]

[0025] [Figure 1]

[0028] 1 is a cross-sectional schematic diagram of the human eye and its internal anatomical structures. [Figure 2]

[0029] FIG. 2 is a cross-sectional schematic diagram of the iridocorneal angle of the eye of FIG. 1. [Figure 3]

[0030] FIG. 3 is a cross-sectional schematic diagram detailing the anatomical structure of the iridocorneal angle of FIG. 2, including the trabecular meshwork, Schlemm's canal, and one or more collecting canals branching off from Schlemm's canal. [Figure 4]

[0031] 4 is a cross-sectional schematic diagram of various aqueous humor outflow pathways through the trabecular meshwork, Schlemm's canal, and collecting duct of FIG. 3. [Figure 5]

[0032] 1 is a schematic cross-sectional view of the human eye showing the various axes associated with the eye. [Figure 6]

[0033] 1 is a cross-sectional schematic diagram of two different optical paths, including an angled path and a parallel path, that one or more beams may take to reach the iridocorneal angle of the eye. [Figure 7]

[0034] FIG. 1 is a block diagram of an integrated surgical system for non-invasive glaucoma surgery, including a control system, a laser source, an OCT imaging device, a visual observation device, a beam conditioner and scanner, a beam combiner, a focusing objective head, and a patient interface. [Figure 8]

[0035] FIG. 8 is a detailed block diagram of the integrated surgical system of FIG. 7. [Figure 9a]

[0036] FIG. 8 is a schematic diagram of an embodiment in which the focusing objective head and patient interface of the integrated surgical system of FIG. 7 are configured to be fixedly coupled to and decoupled from each other, and the patient interface is configured to be fixedly coupled to and decoupled from the eye. [Figure 9b]

[0037] Schematic diagram of the embodiment of FIG. 9a, showing the focusing objective lens head separated from the patient interface and the patient interface separated from the eye. [Figure 9c]

[0038] Exploded schematic diagram of the configuration of the first optical subsystem formed by the optical systems of the focusing objective lens head and the patient interface included in FIGS. 9a and 9b. [Figure 10a]

[0039] Schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem of FIG. 9c. [Figure 10b] Schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem of FIG. 9c. [Figure 10c] Schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem of FIG. 9c. [Figure 10d] Schematic diagram of another configuration of the first optical subsystem that can be used instead of the first optical subsystem of FIG. 9c. [Figure 10e1]

[0040] Isometric view of the embodiment of the first optical subsystem from different viewpoints. [Figure 10e2] Isometric view of the embodiment of the first optical subsystem from different viewpoints. [Figure 10e3] Isometric view of the embodiment of the first optical subsystem from different viewpoints. [Figure 11a]

[0041] Schematic diagram of an embodiment in which the focusing objective lens head of the integrated surgical system of FIG. 7 is rotatably connected to an interface structure configured to be fixedly connected to and separated from the patient interface, and the patient interface is fixedly connected to and separated from the eye. [Figure 11b]

[0042] 11b is a schematic diagram of the embodiment of FIG. 11a, showing the focusing objective head detached from the interface structure, the interface structure detached from the patient interface, and the patient interface detached from the eye. [Figure 12a]

[0043] FIG. 10 is a schematic diagram of another embodiment in which the focusing objective head of the integrated surgical system of FIG. 7 is rotatably coupled to an interface structure configured to be fixedly coupled to and detached from a patient interface, and the patient interface is configured to be fixedly coupled to and detached from the eye. [Figure 12b]

[0044] 12b is a schematic diagram of the embodiment of FIG. 12a, showing the focusing objective head detached from the interface structure, the interface structure detached from the patient interface, and the patient interface detached from the eye. [Figure 13a]

[0045] 9 is a schematic diagram of the components of the integrated surgical system of FIGS. 7 and 8 functionally arranged to form a first optical subsystem and a second optical subsystem that enable access to the iridocorneal angle along the angled and parallel optical paths of FIG. 6, respectively. [Figure 13b]

[0046] 13b is a schematic diagram showing a laser beam passing through the first optical subsystem of FIG. 13a along an angled optical path and entering the eye, and an OCT beam passing through the first optical subsystem along a parallel optical path. [Figure 14]

[0047] 8 is a three-dimensional schematic diagram of the anatomical structure of the iridocorneal angle, including the trabecular meshwork, Schlemm's canal, collector channels branching from Schlemm's canal, and the surgical volume of ocular tissue treated by the integrated surgical system of FIG. [Figure 15]

[0048] 14 is a two-dimensional schematic diagram of the anatomical structure of the iridocorneal angle and a three-dimensional laser treatment pattern applied by the integrated surgical system of FIG. 7 to affect the surgical volume of ocular tissue between Schlemm's canal and the anterior chamber as shown in FIG. 14. [Figure 16]

[0049] 16 is a three-dimensional schematic view of FIG. 14 after treating a surgical volume of ocular tissue with a laser according to the laser treatment pattern of FIG. 15 to form an opening between Schlemm's canal and the anterior chamber of the eye. [Figure 17a]

[0050] FIG. 1 is a schematic diagram of a three-dimensional laser treatment pattern formed by stacking multiple two-dimensional treatment planes or layers. [Figure 17b]

[0051] FIG. 1 is a schematic diagram of a two-dimensional treatment layer defined by an array of spots. [Figure 18a]

[0052] FIG. 16 is a schematic diagram of two layers of the laser scanning process, based on the treatment pattern of FIG. 15, where the scan begins at a shallow depth adjacent to the anterior chamber and progresses toward Schlemm's canal. [Figure 18b] FIG. 16 is a schematic diagram of two layers of the laser scanning process, based on the treatment pattern of FIG. 15, where the scan begins at a shallow depth adjacent to the anterior chamber and progresses toward Schlemm's canal. [Figure 19a]

[0053] FIG. 16 is a schematic diagram of the two layers of the laser scanning process, based on the treatment pattern of FIG. 15, where the scan begins deep adjacent to Schlemm's canal and progresses toward the anterior chamber. [Figure 19b] 16 is a schematic diagram of two layers of the laser scanning process, based on the treatment pattern of FIG. 15, where the scan begins at a deep depth adjacent to Schlemm's canal and progresses toward the anterior chamber. [Figure 20]

[0054] 1 is a flowchart of a method for imaging and treating an eye via non-collinear laser and imaging paths. [Figure 21]

[0055] An OCT image that includes an image obtained from a circumferential (or tangential) OCT scan and an image obtained from a radial OCT scan. DETAILED DESCRIPTION OF THE INVENTION

[0026]

[0056] Disclosed herein is an integrated surgical system configured to image and treat an eye having an optical axis, a cornea, an anterior chamber, and an iridocorneal angle, the system including a laser source configured to output a laser beam, an OCT imaging device configured to output an OCT beam, a first optical subsystem configured to couple to the eye, a second optical subsystem optically coupled to the laser source, the OCT imaging device, and the first optical subsystem, and a control system coupled to the laser source, the OCT imaging device, and the second optical subsystem.

[0027]

[0057] The first optical subsystem receives an OCT beam incident on an entry surface of the first optical subsystem along an OCT input axis that is 1) substantially parallel to the optical axis of the eye, 2) radially offset from the optical axis of the eye, and 3) extends through the cornea to a portion of the iridocorneal angle at a point along a circumferential angle of the eye. The first optical subsystem is also configured to receive a laser beam incident on an entry surface of the first optical subsystem along a laser input axis and direct it along an angled optical path through the first optical subsystem, through the cornea, and through the anterior chamber into a target volume of ocular tissue at the portion of the iridocorneal angle.

[0028]

[0058] The second optical subsystem is configured to transmit the laser beam along a laser input axis to the first optical subsystem and the OCT beam along an OCT input axis to the first optical subsystem. The control system is configured to control the OCT imaging device to output the OCT beam to the second optical subsystem and image a portion of the iridocorneal angle with the OCT beam, and to control the laser source to output the laser beam to the second optical subsystem and photodisrupt at least a portion of the target volume of ocular tissue.

[0029]

[0059] In the integrated surgical system disclosed herein, an OCT beam and a laser beam are each directed along a different optical axis or path into the iridocorneal angle of the eye. The laser beam enters the eye through the cornea, passes through the aqueous humor in the anterior chamber, and enters the iridocorneal angle of the eye, where it modifies the targeted ocular tissue. The OCT beam enters the eye from the cornea to the treatment site and images the tissue surrounding the treatment volume directly through the cornea without passing through the anterior chamber, thereby avoiding the aqueous humor. Therefore, by-products of laser-tissue interaction, such as air bubbles and / or tissue debris in the aqueous humor, do not obstruct the view of the OCT beam. Additionally, the OCT beam does not pass through the interface between the trabecular meshwork, cornea, and aqueous humor, eliminating aberrations and absorption losses due to passing through tissue interfaces, improving the quality of the OCT image.

[0030]

[0060] Laser surgery procedures for treating glaucoma involve imaging the iridocorneal angle, including the trabecular meshwork. Known laser treatment procedures can use optical coherence tomography (OCT) imaging to identify ocular tissues to be treated. In such procedures, the OCT beam can be delivered to the iridocorneal angle through a common optical system, along the same optical path and collinearly with the laser beam. During laser treatment, by-products of laser treatment, such as gas bubbles and / or tissue debris from laser photodisruption, can form in the optical path and obscure the diagnostic OCT beam, affecting the quality of the OCT image. Furthermore, as the OCT beam passes through various tissue interfaces, aberrations and absorption losses can occur, affecting the quality of the OCT image. Another drawback of delivering the OCT beam collinearly with the laser beam is the inability to obtain OCT images with sufficient resolution to identify clinically important features, such as Schlemm's canal. This lack of depth penetration can limit the clinical usefulness of OCT images.

[0031]

[0061] The integrated surgical system disclosed herein directs the OCT beam into the eye in a manner that avoids the by-products of laser treatment and optical aberrations and absorption by the eye tissue, thereby providing high quality OCT images.

[0032]

[0062] Femtosecond Laser Source

[0063] The surgical component of the integrated surgical system disclosed herein is a femtosecond laser. The femtosecond laser provides highly localized, non-thermal, photodisruptive laser-tissue interaction while minimizing collateral damage to surrounding ocular tissue. For optically transparent tissue, the photodisruptive interaction of the laser is utilized. The primary mechanism by which laser energy is deposited in ocular tissue is not through absorption, but through a highly nonlinear multiphoton process. This process is only effective at the focal point of a pulsed laser with high peak intensity. Regions through which the beam passes but not the focal point are unaffected by the laser. Therefore, the interaction region with ocular tissue is highly localized both laterally and axially along the laser beam. This process can also be used in weakly absorbing or scattering tissue. While femtosecond lasers with photodisruptive interaction have been effectively used in ophthalmic surgical systems and commercialized in other ophthalmic laser procedures, none have been used in an integrated surgical system to access the iridocorneal angle.

[0033]

[0064] In known refractive procedures, femtosecond lasers are used to create corneal flaps, pockets, tunnels, arcuate incisions, lenticule incisions, and partial or complete corneal incisions for corneal transplants. In cataract procedures, lasers make circular incisions in the eye's capsule to create capsulorhexis and various patterns of incisions in the lens to break up the interior of the lens into small pieces for easier removal. Corneal incisions are made to open the eye, allowing access for manual surgical instruments and the insertion of phacoemulsification and intraocular lens insertion devices. Several companies are currently commercializing such surgical systems, including the IntraLase system sold by Johnson & Johnson Vision of Santa Ana, California, the LenSx and WaveLight systems sold by Alcon of Fort Worth, Texas, the Lensar laser system sold by Lensar, Inc. of Orlando, Florida, the femtolaser family sold by Ziemer Ophthalmics, Alton IL of Alton, Illinois, the Victus femtosecond laser platform sold by Bausch & Lomb of Rochester, New York, and the Catalys precision laser system sold by Johnson & Johnson of Santa Ana, California.

[0034]

[0065] These existing systems were developed for the specific application of corneal, lens, and capsule surgery and are unable to perform surgery on the iridocorneal angle 13 for several reasons. First, the iridocorneal angle 13 is inaccessible with these surgical laser systems because it is too far from the periphery and outside the surgical range of these systems. Second, the angle of the laser beam from these systems is along the optical axis 24 relative to the eye 1, which is inappropriate for reaching the iridocorneal angle 13, where significant scattering and optical distortion occurs at the applied wavelengths. Third, the imaging capabilities of these systems may not have the accessibility, penetration depth, or resolution to image tissues along the trabecular outflow pathway 40 with sufficient detail and contrast.

[0035]

[0066] According to the integrated surgical system disclosed herein, access to the iridocorneal angle 13 for laser treatment purposes is provided along an angled optical path 30 that is angled relative to the optical axis 24 of the eye 1. Tissues along this angled optical path 30, such as the cornea 3 and aqueous humor 8 in the anterior chamber 7, are transparent to wavelengths between approximately 400 nm and 2500 nm, making femtosecond lasers operating in this range femtosecond lasers can be used. Such mode-locked lasers operate at fundamental wavelengths using titanium, neodymium, or ytterbium active materials. Nonlinear frequency conversion techniques, frequency doubling, frequency tripling, sum and difference frequency mixing techniques, and optical parametric conversion, known in the art, can convert the fundamental wavelength of these lasers to virtually any wavelength within the aforementioned transparent wavelength range of the cornea.

[0036]

[0067] Existing ophthalmic surgical systems apply lasers with pulse durations longer than 1 nanosecond, have higher photodisruption threshold energies, and require higher pulse energies, resulting in larger photodisruptive interaction regions and consequently reduced precision of surgical treatment. However, when treating the iridocorneal angle 13, greater surgical precision is required. To this end, integrated surgical systems can be configured to apply lasers with pulse durations between 10 femtoseconds (fs) and 1 nanosecond (ns) to generate photodisruptive interactions between the laser beam and the ocular tissue at the iridocorneal angle 13. While lasers with pulse durations less than 10 femtoseconds are available, such laser sources are more complex and expensive. Lasers with the desired characteristics described, e.g., pulse durations between 10 femtoseconds (fs) and 1 nanosecond (ns), are commercially available from several vendors, including Newport (Irvine, California), Coherent (Santa Clara, California), Amplitude Systems (Pessac, France), and NKT Photonics (Birkerød, Denmark).

[0037]

[0068] OCT imaging

[0069] The imaging component of the integrated surgical system disclosed herein is an optical coherence tomography (OCT) imaging device. OCT technology can be used to diagnose, position, and guide laser surgery on the iridocorneal angle of the eye. For example, with reference to FIGS. 1-3 , OCT imaging can be used to determine the structural and geometric condition of the anterior chamber 7, assess potential obstruction of the trabecular outflow pathway 40, and determine the accessibility of ocular tissue for treatment. As previously mentioned, a collapsed iris 9 within the anterior chamber 7 can obstruct the flow of aqueous humor 8, resulting in angle-closure glaucoma. In open-angle glaucoma, the macroscopic shape of the angle is normal, but the permeability of ocular tissue can be affected by obstruction of tissue along the trabecular outflow pathway 40 or by collapse of Schlemm's canal 18 or collecting canal 19.

[0038]

[0070] According to the integrated surgical system disclosed herein, access to the iridocorneal angle 13 for OCT imaging purposes is provided along a parallel optical path 31 substantially parallel to the optical axis 24 to the eye 1. OCT imaging provides the spatial resolution, tissue penetration, and contrast necessary to resolve fine details of ocular tissue. Scanning OCT images yield two-dimensional (2D) cross-sectional images of ocular tissue. As another aspect of the integrated surgical system, the 2D cross-sectional images can also be processed and analyzed to determine the size, shape, and location of ocular structures targeted for surgery. While it is possible to reconstruct a three-dimensional (3D) image from multiple 2D cross-sectional images, this is often not necessary. 2D image acquisition, analysis, and display can be faster while still providing all the information necessary for accurate surgical targeting.

[0039]

[0071] Optical Coherence Tomography (OCT) is an imaging modality capable of providing high-resolution images of materials and tissues. Imaging is based on reconstructing spatial information about a sample from spectral information from scattered light within the sample. Spectral information is extracted by comparing the spectrum of light entering the sample with the spectrum of light scattered from the sample using interferometry. Spectral information along the direction of light propagation within the sample is converted to spatial information along the same axis using a Fourier transform. Information transverse to the OCT beam propagation is typically collected by scanning the beam laterally and repeatedly probing axially during the scan. This method can obtain 2D and 3D images of the sample. Time-domain OCT allows for faster image acquisition because the interferometer is not mechanically scanned and interference from a wide range of optical spectra is simultaneously recorded. This implementation is called spectral-domain OCT. Faster image acquisition can also be achieved by rapidly scanning the wavelength of light from a wavelength-scanning laser, in an arrangement called swept-source OCT.

[0040]

[0072] The axial spatial resolution limit of OCT is inversely proportional to the bandwidth of the probe light used. Both spectral-domain OCT and swept-source OCT can achieve axial spatial resolution of less than 5 micrometers (μm) with sufficiently wide bandwidths of 100 nanometers (nm) or greater. In spectral-domain OCT, the spectral interference pattern is recorded simultaneously on a multichannel detector such as a charge-coupled device (CCD) or complementary metal-oxide semiconductor (CMOS) camera, whereas in swept-source OCT, the interference pattern is recorded in successive time steps using a high-speed photodetector and electronic digitizer. While swept-source OCT offers some advantages in acquisition speed, both types of systems are rapidly evolving and improving, and their resolution and speed are sufficient for the purposes of the integrated surgical system disclosed herein. Standalone OCT systems and OEM components are currently commercially available from several vendors, including Optovue Inc. (Fremont, CA), Topcon Medical Systems (Oakland, NJ), Carl Zeiss Meditec AG (Germany), Nidek (Aichi, Japan), Thorlabs (Newton, NJ), Santec (Aichi, Japan), and Axsun (Villarsia, MA).

[0041]

[0073] Visual Observation Device

[0074] Another imaging component of the integrated surgical system disclosed herein is a visual observation device. The visual observation device may include, for example, a video camera, a telescope, and one or more illumination sources. The camera may be a digital camera equipped with a gonioscopic lens to provide a gonioscopic image of the eye. The illumination source is positioned to optimally illuminate an object of interest, such as the iridocorneal angle of the eye, including the trabecular meshwork. The illumination source may be an LED or light transmitted via a fiber optic cable. There are many illumination methods available: a refractive ballistic method, in which the light source is placed in air and refracts through an optical element to reach the trabecular meshwork; a transmission ballistic method, in which the illumination source is inserted into a pre-drilled hole or feature inside the lens and glued in place using a refractive index-matching epoxy; or a reflective method, in which light from the illumination source reflects off a designed reflective surface of the lens close to the eye before hitting the trabecular meshwork.

[0042]

[0075] Access to the iridocorneal angle

[0076] 6 , 7 , 8 , and 13 a, a feature provided by the integrated surgical system 1000 disclosed herein is the ability to access target ocular tissue within the iridocorneal angle 13 by different light rays along different non-collinear optical paths 30, 31. In some embodiments, the iridocorneal angle 13 of the eye can be accessed by one or more beams via the integrated surgical system along a first optical path 30 that passes through the cornea 3 and through the aqueous humor 8 in the anterior chamber 7, while one or more other beams can access the iridocorneal angle 13 along a second optical path 31 that passes through the cornea 3 without passing through the aqueous humor 8 in the anterior chamber 7 and enters the iridocorneal angle 13 of the eye. For example, one or more of a laser beam and a visual observation beam access the iridocorneal angle 13 of the eye along the first optical path 30, while an OCT beam accesses the iridocorneal angle 13 of the eye along the second optical path 31. The first optical path 30 is at an angle to the eye's optical axis 24 and is therefore referred to herein as an angled optical path or angled optical path. The second optical path 31 is substantially parallel to the optical axis 24 and is therefore referred to herein as a parallel beam path or parallel optical path. By substantially parallel, we mean within 20 degrees of parallelism.

[0043]

[0077] 13a, an optical system 1010 disclosed herein is configured to direct a first light beam, e.g., laser beam 201, along an angled optical path 30 (shown in FIG. 6) to the iridocorneal angle 13 of the eye, while directing a second light beam, e.g., OCT beam 301, along a parallel optical path 31 (shown in FIG. 6) to the iridocorneal angle 13. The optical system 1010 includes a first optical subsystem 1001 and a second optical subsystem 1002.

[0044]

[0078] Continuing with FIG. 13a, first optical subsystem 1001 includes exit lens 710, prism 752, and window 801. Exit lens 710 (also referred to as a superdome) has opposite input and output sides. The input side of exit lens 710 is defined by a convex surface, and the output side is defined by a concave surface. The input side of exit lens 710 is positioned to receive a first light beam, e.g., a laser beam. Prism 752 has a flat input face positioned to receive a second light beam, e.g., an OCT beam, and an output face configured to couple with a portion of the convex surface of exit lens 710.

[0045]

[0079] The window 801 has opposite input and output sides. The input side of the window 801 is defined by a convex surface, and the output side is defined by a concave surface. The concave surface of the window 801 is configured to couple with the convex surface of the exit lens 710 to define a first optical axis 705 (also referred to herein simply as the "axis" or "first optical subsystem axis" or simply the "subsystem axis") through the window and the exit lens. The concave surface of the window 801 is configured to detachably couple to the cornea 3 of the eye 1 such that, when coupled to the eye, the first optical axis is generally aligned with the line of sight of the eye, or the optical axis 24 of the eye.

[0046]

[0080] 6 and 13a, the second optical subsystem 1002 is configured to output one or more first light beams, such as the laser beam 201 and / or the visual observation beam 401, to the first optical subsystem 1001 for travel along the first beam path 30. The second optical subsystem 1002 is also configured to output a second light beam (such as the OCT beam 301) to the first optical subsystem 1001 for travel along the second beam path 31.

[0047]

[0081] With respect to the first light beam, the optical system 1010 is configured to direct the first light beam, e.g., laser beam 201 and / or visual observation beam 401, to be incident on the convex surface of the exit lens 710 along the laser axis 706 at an angle α offset from the first optical subsystem axis 705. The respective shapes and respective refractive indices of the exit lens 710 and window 801 are configured to compensate for the refraction and distortion of the light rays by bending the light beam so that it is directed through the cornea 3 of the eye and toward the iridocorneal angle 13. More specifically, the first optical subsystem 1001 bends the first light beam, e.g., laser beam 201, so that it exits the first optical subsystem and enters the cornea 3 at the appropriate angle, thereby passing through the cornea and aqueous humor 8 of the anterior chamber 7 and traveling along the angled optical path 30 toward the iridocorneal angle 13.

[0048]

[0082] Referring to FIG. 6 , accessing the iridocorneal angle 13 along an angled optical path 30 provides several advantages. The advantage of this angled optical path 30 over the iridocorneal angle 13 is that the light beam passes through mostly transparent tissue, such as the cornea 3 and aqueous humor 8 in the anterior chamber 7. Therefore, scattering of the beam by tissue is not significant. This is beneficial when the light beam is a laser beam or a visual observation light beam. An additional advantage of the angled optical path 30 through the cornea 3 and the anterior chamber 7 to the iridocorneal angle 13 is that the laser beam avoids directly irradiating the retina 11. As a result, higher average power laser light can be used for diagnostic imaging as well as surgery, resulting in faster surgery and reduced tissue movement during surgery.

[0049]

[0083] 6 and 13a, with respect to the second optical beam, the optical system 1010 is configured so that the second optical beam, e.g., the OCT beam 301, is incident on the flat input surface of the prism 752 along an OCT axis 707 that is radially offset from the subsystem axis 705 and has a direct path to the iridocorneal angle of the eye. The respective shapes and respective refractive indices of the prism 752, the exit lens 710, and the window 801 are configured to compensate for refraction and distortion of the OCT beam by bending the OCT beam so that it passes through the cornea 3 of the eye and toward the iridocorneal angle 13. More specifically, the first optical subsystem 1001 directs the OCT beam 301 so that it exits the first optical subsystem and enters the cornea 3 at the proper angle, thereby traveling through the cornea along a parallel optical path 31 toward the iridocorneal angle 13 while avoiding the anterior chamber 7.

[0050]

[0084] As noted above, providing OCT beam access to the iridocorneal angle 13 along a parallel optical path 31 separate from the angled optical path 30 of the laser beam provides several advantages. For example, the parallel optical path 31 of the OCT beam avoids by-products of laser treatment that may be in the region of the angled optical path 30. The parallel optical path 31 also avoids optical aberrations and absorption at ocular tissue interfaces, such as the cornea-aqueous humor interface and the aqueous humor-trabecular meshwork interface. The avoidance of optical aberrations and absorptions: 1) provides higher OCT resolution and contrast and higher sensitivity; 2) allows the OCT beam to penetrate deeper into tissue, fully viewing the vicinity of Schlemm's canal and collector channels; and 3) allows the use of lower OCT beam power and different wavelengths for OCT.

[0051]

[0085] Providing OCT beam access to the iridocorneal angle 13 along a parallel optical path 31 allows the OCT beam to access, identify, and target various tissues in the periphery of the cornea for laser treatment, separate from the angled optical path 30 of the laser beam. For example, this allows imaging and targeted treatment of Schlemm's canal, collecting canals, aqueous veins, and scleral tissue, as well as the trabecular meshwork. Providing OCT beam access to the iridocorneal angle 13 along a parallel optical path 31 also provides the ability to image tissue during and immediately after surgical laser treatment, separate from the angled optical path 30 of the laser beam, thereby providing direct feedback on surgical performance during and after treatment. OCT beam access to the iridocorneal angle 13 along a parallel optical path 31 also provides images suitable for pre-surgical treatment planning. Separating the OCT optical path from the laser optical path allows for optimization of each beam to achieve lower aberrations, lower chromatic dispersion, and independent polarization adjustment.

[0052]

[0086] Having now generally described the integrated surgical system 1000 and some of its features and advantages, the system and its components will now be described in more detail.

[0053]

[0087] Integrated Surgical System

[0088] Referring to FIG. 7 , an integrated surgical system 1000 for non-invasive glaucoma surgery includes a control system 100, a surgical component 200, a first imaging component 300, and an optional second imaging component 400. In the embodiment of FIG. 7 , the surgical component 200 is a femtosecond laser source, the first imaging component 300 is an OCT imaging device, and the optional second imaging component 400 is a visual observation device, such as a microscope with an illumination source, for direct viewing or camera viewing. The visual observation device 400 provides visual illumination and observation to assist the surgeon in docking the eye with the system. The visual observation device 400, together with the OCT imaging device 300, provides images to aid in identifying the surgical site. Other components of the integrated surgical system 1000 include a beam conditioner and scanner 500, a beam combiner 600, a focusing objective head 700, and a patient interface 800.

[0054]

[0089] The control system 100 may be a single computer or multiple interconnected computers configured to control the hardware and software components of the other components of the integrated surgical system 1000. The user interface 110 of the control system 100 accepts instructions from a user and displays information for the user to view. User input information and commands include, but are not limited to, system commands, motion control for docking the patient's eye 1 to the system 1000, selecting a pre-programmed or live-generated surgical plan, determining the surgical site based on images of the eye, including visual observations and OCT images, navigating menu selections, setting surgical parameters, responding to system messages, determining and approving the surgical plan, and commands for executing the surgical plan. System output to the user includes, but is not limited to, display of system parameters and messages, display of images of the eye, including visual observations and OCT images, and graphical, numerical, and textual displays of the surgical plan and surgical progress.

[0055]

[0090] The control system 100 is connected to the other components 200, 300, 400, and 500 of the integrated surgical system 1000. Control signals from the control system 100 to the femtosecond laser source 200 function to control the internal and external operating parameters of the laser source, such as power, repetition rate, and beam shutter. Control signals from the control system 100 to the OCT imaging device 300 function to control OCT beam parameters and the acquisition, analysis, and display of OCT images. Control signals to the laser scanning system may include the position, size, and shape of a surgical pattern, expressed in terms of the intended location of the laser focal spot and the position coordinates of the laser's scan path throughout the surgical volume. These types of control signals may be preprogrammed, allowing the operator to select one or more control parameters. Control parameters of a surgical pattern may include the position of the laser pulse pattern, pattern shape, length, width, depth, laser spot, line and layer separation, and energy. Control signals between the various subsystems and components are coordinated prior to operating the surgical system. Calibration includes calibrating the pixel coordinates acquired and displayed by the visual observation device 400 and OCT imaging device 300 to actual physical coordinates within the eye, and calibrating the commanded movements of the OCT and laser scanner systems to the actual OCT and laser beam displacements within the eye.

[0056]

[0091] Instructing the integrated surgical system 1000 to perform a surgical incision involves docking the system to the eye, acquiring and displaying visual observation and OCT images on a computer screen, determining the coordinate location and other parameters of the intended surgical incision based on the displayed images, and instructing the control system 100 to execute the surgical pattern based on the information gathered from these images. The image-based parameters may be determined by an operator of the integrated surgical system 1000 or by image processing and analysis computer algorithms. Instructions using these parameters may be provided by the operator as input data in the form of text, mouse clicks, or drag-and-drop commands on a computer screen. Alternatively, a system processor included in the control system 100 generates instructions to be executed by the control system based on previously determined parameters.

[0057]

[0092] The laser beam 201 from the femtosecond laser source 200 and the OCT beam 301 from the OCT imaging device 300 are directed to a beam conditioner and scanner unit 500. The beam conditioner and scanner 500 includes components, such as scan mirrors, for scanning the laser beam 201 and the OCT beam 301 independently of each other. Various types of scanners can be used to scan the laser beam 201 and the OCT beam 301. For scanning laterally relative to the beams 201 and 301, angle-scanning galvanometer scanners are available, for example, from Cambridge Technology, Inc. of Bedford, Massachusetts, and Scanlab, Inc. of Munich, Germany. To optimize scanning speed, the scan mirror is typically set to the smallest size possible to support the required scan angle and numerical aperture of the beam at the target location. The ideal beam size at the scanner is typically different from the beam size of the laser beam 201 or the OCT beam 301, and also different from that required at the entrance of the focusing objective head 700. Therefore, beam conditioners may be applied before, after, or between individual scanners. Beam conditioner and scanner 500 includes scanners for scanning the beam laterally and axially. Axial scanning varies the depth of focus in the region of interest. Axial scanning can be performed by axially moving a lens in the beam path using a servo motor or stepper motor.

[0058]

[0093] The laser beam 201 and the visual observation beam 401 are combined in a dichroic, polarizing, or other type of beam combiner 600 to reach a common target or surgical volume within the eye. The beam combiner 600 uses a dichroic or polarizing beam splitter to split and recombine light having different wavelengths and / or polarizations. The beam combiner 600 may also include optics to modify certain parameters of the individual beams 201, 401, such as beam size, beam angle, and divergence.

[0059]

[0094] To resolve ocular tissue structures in sufficient detail, the imaging components 300, 400 of the integrated surgical system 1000 can provide the OCT beam 301 and the visual observation beam 401 with a spatial resolution of a few micrometers. The resolution of the OCT beam 301 is the spatial dimension of the smallest feature that can be recognized in the OCT image. This is primarily determined by the wavelength and spectral bandwidth of the OCT source, the quality of the optics that delivers the OCT beam 301 to the target site within the eye, the numerical aperture of the OCT beam, and the spatial resolution of the OCT imaging device at the target site. In one embodiment, the resolution of the OCT beam 301 of the integrated surgical system 1000 is 5 μm or less.

[0060]

[0095] Similarly, the surgical laser beam 201 provided by the femtosecond laser source 200 can be delivered to a target location with an accuracy of a few micrometers. The resolution of the laser beam 201 is the spatial dimension of the smallest feature at the target location that can be altered by the laser beam without significantly affecting the surrounding ocular tissue. This is primarily determined by the wavelength of the laser beam 201, the quality of the optics that delivers the laser beam to the target location within the eye, the numerical aperture of the laser beam, the energy of the laser pulses in the laser beam, and the spatial resolution of the laser scanning system at the target location. Furthermore, to minimize the laser's threshold energy for photodisruptive interaction, the laser spot size must be approximately 5 μm or less.

[0061]

[0096] It should be noted that the visual observation beam 401 is acquired by the visual observation device 400 using fixed, non-scanning optics, while the OCT beam 301 of the OCT imaging device 300 is scanned across in two lateral directions. The laser beam 201 of the femtosecond laser source 200 is scanned in two lateral dimensions, and the depth of focus is scanned axially.

[0062]

[0097] In an actual embodiment, beam conditioning, scanning, and optical path combination are specific functions performed on the laser, OCT, and visual observation light beams. These functions may occur in a different order than that shown in FIG. 7 . The specific optical hardware that manipulates the beams to perform these functions can have multiple configurations for how the optical hardware is arranged. They can be arranged to manipulate each individual light beam separately, or in other embodiments, a single component can combine functions to manipulate different beams. In the embodiment disclosed herein, beam conditioner and scanner 500 includes two sets of scanners: one for scanning laser beam 201 and one for scanning OCT beam 301. Individual beam conditioners within beam conditioner and scanner 500 set the beam parameters for each of laser beam 201 and OCT beam 301. While various combinations of optical hardware devices are possible in an integrated surgical system, the following section details example devices.

[0063]

[0098] Beam Transmission

[0099] In the following description, the term "beam" may refer to either a laser beam, an OCT beam, an illumination beam, or a visual observation beam, depending on the context. The term "collinear beam" refers to two or more different beams that are combined by the optics of the integrated surgical system 1000 and share the same path to the same target location on the eye when they enter the eye. The term "non-collinear beam" refers to two or more different beams that take different paths to the eye. The term "co-target beam" refers to two or more different beams that take different paths to the eye but target the same location on the eye. In a collinear beam, different beams are combined by a dichroic or polarizing beam splitter to share the same path to the eye and are transmitted along the same optical path through different beam multiplexing. In a non-collinear beam, different beams are transmitted to the eye along different optical paths that are separated spatially or by the angle between the beams. In the following description, any of the aforementioned beams or combined beams may be collectively referred to as an optical beam. The terms "distal" and "proximal" may be used to designate the direction of travel of the beam or the physical location between components in the integrated surgical system. The distal direction refers to the direction toward the eye, such that the OCT beam output by the OCT imaging device travels distally toward the eye, and the proximal direction refers to the direction away from the eye, such that the OCT return beam from the eye travels proximally toward the OCT imaging device.

[0064]

[0100] 8 , according to embodiments disclosed herein, an integrated surgical system is configured to transmit a laser beam 201, an OCT beam 301, and a visual observation beam 401, respectively, in a distal direction toward the eye 1 and to receive an OCT return beam and a visual observation return beam, respectively, returning from the eye 1. The laser beam 201 and the visual observation beam 401 are transmitted along a first optical path or angled optical path to a region of the eye 1 that includes the surgical volume 720, and the OCT beam 301 is transmitted along a second optical path or parallel optical path to the same region of the eye. Thus, the laser beam 201 and the OCT beam 301 are co-targeted, non-collinear beams.

[0065]

[0101] For visual observation, the visual observation beam 401 directed to the eye is a light beam from an illumination source of the visual observation device, and the visual observation return beam returning from the eye 1 is a reflection of that light beam.

[0066]

[0102] Regarding laser beam transmission, the laser beam 201 output by the femtosecond laser source 200 passes through a beam conditioner 510, which sets the basic beam parameters, beam size, and divergence. The beam conditioner 510 may also perform additional functions, such as setting the beam power or pulse energy and turning the beam on or off with a shutter. After passing through the beam conditioner 510, the laser beam 210 enters an axial scan lens 520. The axial scan lens 520 may comprise a single lens or a group of lenses and may be moved in an axial direction 522 by a servo motor, stepper motor, or other control mechanism. Movement of the axial scan lens 520 in the axial direction 522 changes the axial distance of the focal point of the laser beam 210 at its focal point.

[0067]

[0103] The intermediate focus 722 is set to lie within and scannable within a conjugate surgical volume 721, which is the image conjugate of the surgical volume 720 determined by the focusing objective head 700. The surgical volume 720 is the spatial extent of the region of interest within the eye where imaging and surgery are performed. In the case of glaucoma surgery, the surgical volume 720 is near the iridocorneal angle 13 of the eye. A pair of lateral scanning mirrors 530, 532 rotated by galvanometer scanners scans the laser beam 201 in two essentially orthogonal lateral directions, e.g., the x- and y-directions. The laser beam 201 is then directed toward a beam coupling mirror 602 configured to couple the laser beam 201 with the visual observation beam 401.

[0068]

[0104] The distally traveling combined laser / visible light beam 201 / 401 then passes through a focusing lens 750 included in the focusing objective head 700, reflects off a reflective surface 740, which may be a planar beam folding mirror or a facet in the optical system, and then passes through the exit lens 710 of the focusing objective head 700 and a patient interface window 801, where the intermediate focus 722 of the laser beam in the conjugate surgical volume 721 is re-imaged to a focus within the surgical volume 720. The focusing objective head 700 re-images the intermediate focus 722 through the patient interface window 801 onto the ocular tissue within the surgical volume 720. In one configuration, the faceted reflective surface 740 within the optic has a specialized coating for broadband reflection (visible, OCT, femtosecond) to reduce the difference in group delay dispersion (GDD) between s- and p-polarized light.

[0069]

[0105] Regarding OCT beam transmission, the OCT beam 301 output by the OCT imaging device 300 passes through a beam conditioner 511, an axially movable focusing lens 521, and a lateral scanner equipped with scanning mirrors 531 and 533. The focusing lens 521 is used to set the focal position of the OCT beam in the conjugate surgical volume 721 and the actual surgical volume 720. To acquire an OCT axial scan, the focusing lens 521 is not scanned. The axial spatial information of the OCT image is obtained by Fourier transforming the spectra of the OCT return beam 301 and the reference beam 302, which are recombined by an interferometer. However, if the surgical volume 720 is divided into multiple axial segments, the focusing lens 521 can be used to refocus. This method allows the optimal imaging spatial resolution of the OCT image to be extended beyond the Rayleigh range of the OCT signal beam, at the expense of the time spent scanning at multiple ranges.

[0070]

[0106] After the scanning mirrors 531 and 533, traveling distally toward the eye 1, the OCT beam 301 passes through an OCT focusing lens 751 included in the focusing objective head 700 and is reflected by a reflective surface 742 (also referred to herein as an "OCT mirror"), which may be a planar beam folding mirror or a facet within the optical system. Continuing distally, the OCT beam 301 passes through a prism 752 and an exit lens 710 of the focusing objective head 700, and passes through a window 801 of the patient interface 800 to reach a focal point within the surgical volume 720.

[0071]

[0107] The scattered OCT return beam 301 from the ocular tissue travels in the proximal direction and returns to the OCT imaging device 300 along the same path as previously described in reverse. The reference beam 302 from the OCT imaging device 300 passes through a reference delay path and returns to the OCT imaging device via a movable mirror 330. The reference beam 302 is interferometrically coupled with the OCT return beam 301 on its return within the OCT imaging device 300. The delay in the reference delay path can be adjusted by moving the movable mirror 330 to equalize the optical paths of the OCT return beam 301 and the reference beam 302. To achieve the best axial OCT resolution, the OCT return beam 301 and the reference beam 302 are also dispersion compensated to equalize the group velocity dispersion in the two arms of the OCT interferometer.

[0072]

[0108] As the laser beam 201 passes through the cornea 3 and the anterior chamber 7, the beam passes through the posterior and anterior surfaces of the cornea at steep angles that are significantly different from the normal angle of entry. These surfaces in the path of the laser beam 201 create excessive astigmatism and coma that must be compensated for.

[0073]

[0109] 9a and 9b, in an embodiment of the integrated surgical system 1000, the optical components of the focusing objective head 700 and the patient interface 800 form a first optical subsystem configured to provide an angled optical path through the cornea and the anterior chamber 7 of the eye 1 to the iridocorneal angle 13 of the eye, and another parallel optical path through the cornea to the iridocorneal angle of the eye while avoiding the anterior chamber and the aqueous humor therein. The parallel optical path is substantially parallel to a first optical subsystem axis 705 of the first optical subsystem 1001. The first optical subsystem axis 705 approximately coincides with the optical axis 24 of the eye when the first optical subsystem 1001 is coupled to the eye. Thus, the parallel optical path is also substantially parallel to the optical axis 24 of the eye. By substantially parallel, we mean 20 degrees parallel.

[0074]

[0110] Figure 9a shows the eye 1, the patient interface 800, and the focusing objective head 700 connected together. Figure 9b shows the eye 1, the patient interface 800, and the focusing objective head 700 separated from one another. For ease of illustration, in Figures 9a and 9b, the reflective surface 742 of Figure 8 is not shown, and the path of the OCT beam 301 is shown unfolded.

[0075]

[0111] The patient interface 800 optically and physically couples the eye 1 to the focusing objective head 700, which in turn optically couples to the other components of the integrated surgical system 1000. The patient interface 800 serves multiple functions: it fixates the eye relative to the components of the integrated surgical system, creates a sterile barrier between the components and the patient, and provides optical access between the eye and the components. The patient interface 800 is a sterile, disposable device that removably couples to the eye 1 and the focusing objective head 700 of the integrated surgical system 1000.

[0076]

[0112] 9a, 9b, 9c, and 13a, the patient interface 800 includes a window 801 that is part of the first optical subsystem 1001. The window 801 has a concave surface 812 that faces the eye and a convex surface 813 that faces the objective lens opposite the concave surface. Thus, the window 801 has a meniscus shape. The concave surface 812 has a radius of curvature r e and the convex surface 813 has a radius of curvature r w The concave surface 812 is configured to couple to the eye either by direct contact or via an index-matching material, liquid, or gel 807 disposed between the concave surface 812 and the eye 1. The window 801 can be formed of a solid material and has a refractive index n w In one embodiment, window 801 is formed from fused silica and has a refractive index n w is 1.45. Fused silica has the lowest refractive index of any common, inexpensive glass. Fluoropolymers such as Teflon AF are another class of low-index materials with refractive indices lower than fused silica, but their optical quality is inferior to glass and they are relatively expensive for mass production. In another embodiment, window 801 is formed from common glass BK7, with a refractive index n w is 1.50. A radiation resistant version of this glass, BK7G18 from Schott AG, Mainz, Germany, allows gamma sterilization of the patient interface 800 without the optical properties of the window 801 being altered by gamma radiation.

[0077]

[0113] As shown in Figures 9a and 9b, window 801 is surrounded by a wall 803 of patient interface 800 and a fixation device, such as a suction ring 804. When suction ring 804 contacts eye 1, an annular cavity 805 is formed between the suction ring and the eye. When a vacuum is applied to suction ring 804 and the cavity via a vacuum tube or vacuum pump (not shown in Figures 9a and 9b), the vacuum force between the eye and suction ring attaches the eye to patient interface 800 during surgery. When the vacuum is released, eye 1 is released or removed.

[0078]

[0114] The end of the patient interface 800 opposite the eye 1 includes a mounting interface 806 configured to attach to the housing 702 of the focusing objective head 700, thereby fixing the position of the eye relative to other components of the integrated surgical system 1000. The mounting interface 806 can operate mechanically, vacuum, magnetically, or by other principles and can also be detachable from the integrated surgical system. In this configuration, the focusing objective head 700 is fixed to the patient interface 800, and the patient interface 800 is fixed to the eye. In other configurations, described below, an additional component is included between the focusing objective head 700 and the patient interface 800. The additional component is fixed relative to the patient interface 800 but not to the focusing objective head 700. Alternatively, the focusing objective head 700 can rotate within the additional component without rotational torque being transmitted to the patient interface 800, which is fixed to the eye.

[0079]

[0115] 9a, 9b, and 9c, the focusing objective head 700 includes an exit lens 710 and a prism 752 that are part of the first optical subsystem 1001. In the configuration shown in these figures, the exit lens 710 is aspheric and includes a concave surface 711 and a generally convex surface 712 opposite the concave surface, and the prism 752 includes an input or entrance face 753 and an output or exit face 755. The generally convex surface 712 of the exit lens 710 includes a modified front surface 719 configured to couple to the exit face 755 of the prism 752. In one configuration, the modified surface 719 is a flat surface having a shape that matches the shape of the exit face 755 of the prism 752. The shape may be, for example, rectangular. Thus, the exit lens 710 can be described as having a generally meniscus shape with the modified surface 719. The exit lens 710 and prism 752 may be formed from the same or similar solid material as the window 801 of the patient interface 800. In one embodiment, the exit lens 710 is formed from fused silica and has a refractive index n xThe prism 752 is made of fused silica and has the same refractive index, n p It has.

[0080]

[0116] Referring to FIG. 9c, the concave surface 711 has a radius of curvature r y and convex surface 712 is characterized by an aspheric shape. The combination of aspheric convex surface 712 and spherical concave surface 711 results in an exit lens 710 with varying thickness, with the outer peripheral edge 715 of the lens being thinner than the central apex region 717 of the lens. Concave surface 711 is configured to couple to convex surface 813 of window 801.

[0081]

[0117] 10a, 10b, 10c, and 10d, alternative configurations of the first optical subsystem 1001 are contemplated, each of which may be used in place of the first optical subsystem of FIGS. 9a-9c. In each of these configurations, the optical components of the focusing objective head 700 are structured and positioned relative to the window 801 of the patient interface 800 to provide similar laser beam path and OCT beam path functionality as the configurations of FIGS. 9a-9c. In each of FIGS. 10a, 10b, 10c, and 10d, the exit lenses 710a, 710b, 710c, and 710d include reflective surfaces 740 that are coincident with the laser axes 706a, 706b, 706c, and 706d that reflect the laser beam 201 and extend into the iridocorneal angle of the eye.

[0082]

[0118] In Figure 10a, prism 752a is similar to the prism in Figure 9a and directs the OCT beam 301 to exit lens 710d along an OCT axis 707a that extends into the iridocorneal angle of the eye. In Figure 10b, prism 752b is configured to direct the OCT beam 301 to exit lens 710b along an OCT axis 707b that extends into the iridocorneal angle of the eye. In Figures 10c and 10d, each of prisms 752c, 752d has one or more reflective surfaces, and the OCT beam 301 reflects into exit lenses 710c, 710d along OCT axes 707c, 707d that extend into the iridocorneal angle of the eye. Comparing the OCT axes in Figures 10a-10d, OCT axis 707a in Figure 10a is closer to parallel to subsystem axis 705 than OCT axes 707b, 707c, 707d in Figures 10b-10d.

[0083]

[0119] 11a and 11b are schematic diagrams of a configuration in which the focusing objective head 700 is disposed within an interface structure 810a that couples to a patient interface 800. The focusing objective head 700 and the interface structure 810a are mechanically configured and coupled such that the focusing objective head can be rotated within the interface structure relative to the patient interface 800, which is configured to be fixedly coupled to or decoupled from the eye. In this configuration, the focusing objective head 700, including the various optical components 750, 751, 740, 710, and 752 shown in FIGS. 11a and 11b, can rotate about the subsystem axis 705 without rotating the patient interface 800. The mounting interface 806 of the patient interface 800 can be attached to the non-rotating interface structure 810a. Therefore, rotation of the focusing objective head 700 does not transmit rotational torque to the patient interface coupled to the eye. In this configuration, the interface structure 810 a includes a transparent window 811 through which the laser beam 201 and the OCT beam 301 from the exit lens 710 pass into the patient interface 800 window 801 .

[0084]

[0120] 12a and 12b are schematic diagrams of another configuration in which the focusing objective head 700 is positioned within an interface structure 810b that couples to a patient interface 800. Similar to the configuration in FIGS. 11a and 11b, the focusing objective head 700 and the interface structure 810b are mechanically configured and coupled such that the focusing objective head can be rotated within the interface structure relative to the patient interface 800, and the patient interface is configured to be fixedly coupled to or decoupled from the eye. In this configuration, the focusing objective head 700, including the various optical components 750, 751, 740, 710, and 752 shown in FIGS. 12a and 12b, can rotate about the subsystem axis 705 without rotating the patient interface 800. The mounting interface 806 of the patient interface 800 can be attached to a non-rotating interface structure 810a. Therefore, rotation of the focusing objective head 700 does not transmit rotational torque to the patient interface coupled to the eye. In this configuration, interface structure 810b includes an opening 814 through which laser beam 201 and OCT beam 301 from exit lens 710 pass to window 801. An index-matching material, liquid, or gel 807 is placed on the convex surface of window 801, creating a layer between exit lens 710 and the window when components 800, 810b, and 700 are coupled.

[0085]

[0121] Figure 13a is a schematic diagram of the components of the integrated surgical system 1000 of Figures 7 and 8 functionally arranged to form an optical system 1010 having a first optical subsystem 1001 and a second optical subsystem 1002 to enable multi-pass access to a common surgical volume 720 of the iridocorneal angle 13, including access to the surgical volume along an angled beam path by a laser beam 201 and access to the surgical volume along a parallel beam path by an OCT beam 301. Figure 13b is a schematic diagram of the laser beam 201 and the OCT beam 301 passing through the first optical subsystem of Figure 13a.

[0086]

[0122] The optical system 1010 shown in Figure 13a includes components of the focusing objective head 700 and patient interface 800 of Figure 9a. However, for simplicity, Figure 13a does not include all components of the focusing objective head 700 and patient interface 800, and reflections of the laser beam 201 and the OCT beam 301 are not shown. For example, with respect to the laser beam 201, the reflective surface 740 of the focusing objective head 700 shown in Figures 8 and 9a is not shown in Figure 13a, and the path of the laser beam is unfolded or straightened and shown to be incident directly on the exit lens 710 of the focusing objective head 700. With respect to the OCT beam 301, the reflective surface 742 of the focusing objective head 700 shown in Figure 8 is not shown in Figure 13a, and the path of the OCT beam is unfolded and shown to be incident directly on the prism 752 as shown in Figure 9a.

[0087]

[0123] Those skilled in the art will appreciate that adding or removing a planar beam folding mirror or other type of reflective surface does not change the primary operation of the optical system 1010 formed by the first optical subsystem 1001 and the second optical subsystem 1002. It will also be appreciated that the configurations of the optical components, e.g., the exit lens 710 and prism 752 of the focusing objective head 700, are schematic in nature, and that many other configurations are possible, as discussed above with reference to Figures 10a, 10b, 10c, and 10d.

[0088]

[0124] 13a, a first optical subsystem 1001 of an integrated surgical system 1000 includes a prism 752 and an exit lens 710 of the focusing objective head 700 and a window 801 of the patient interface 800. The prism 752, the exit lens 710, and the window 801 are positioned relative to one another to define a first optical subsystem axis 705. The first optical subsystem 1001 is configured to receive a laser beam 201 incident on a convex surface 712 of the exit lens 710 along a second optical axis or laser axis 706 and direct the laser beam through the cornea and the anterior chamber of the eye into a surgical volume 720 at the iridocorneal angle 13 of the eye. The first optical subsystem 1001 is also configured to receive the OCT beam 301 incident at the entry face 753 of the prism 752 along the third optical axis or OCT axis 707 and direct the OCT beam through the cornea of ​​the eye into the surgical volume 720 of the iridocorneal angle 13 of the eye without passing through the anterior chamber and the aqueous humor of the anterior chamber.

[0089]

[0125] During a surgical procedure, the first optical subsystem 1001 is assembled by coupling the convex surface 813 of the window 801 with the concave surface 711 of the exit lens 710. To this end, the focusing objective head 700 is docked with the patient interface 800. As a result, the concave surface 711 of the exit lens 710 is coupled to the convex surface 813 of the window 801. Referring to FIG. 9b, coupling can be achieved by direct contact between the exit lens 710 and the window 801, or by indirect contact via a layer of index-matching fluid. For example, when docking the patient interface 800 to the focusing objective head 700, a drop of index-matching fluid or gel 807 can be applied between the contacting surfaces to eliminate any air gaps that may exist between the two surfaces 711, 813 and help allow the laser beam 201 and the OCT beam 301, respectively, to pass through the gap while minimizing Fresnel reflections and distortions. Referring to Figure 11a, the coupling between the exit lens 710 and the window 801 may be by indirect contact through a transparent window 811 of an interface structure 810a. Referring to Figure 12a, the coupling between the exit lens 710 and the window 801 may be by indirect contact through a layer of index-matching fluid or gel 807 in an opening 814 of an interface structure 810b.

[0090]

[0126] To direct the laser beam 201 through the cornea and the anterior chamber of the eye to the surgical volume 720 at the iridocorneal angle 13 of the eye, the first optical subsystem 1001 is designed to take into account the refraction of the laser beam as it passes through the exit lens 710, the window 801, and the cornea 3. To this end, referring to FIG. 13b, the refractive index n of the exit lens 710 is x and the refractive index n of the window 801 w is the refractive index n of the cornea 3 c is selected taking into account the above and causes appropriate beam bending through the first subsystem 1001 so that as the beam 701 exits the subsystem and passes through the cornea 3, the optical path is adjusted to generally fall within the iridocorneal angle 13.

[0091]

[0127] 13b, we begin with the interface between the window 801 and the cornea 3. If the approach angle at the interface where the laser beam 201 exits the window 801 and enters the cornea 3, i.e., the interface between the concave surface 812 of the window and the convex surface of the cornea 3, is too steep, excessive refraction and distortion can occur. To minimize refraction and distortion at this interface, in one embodiment of the first optical subsystem 1001, the refractive index of the window 801 is adjusted to closely match the refractive index of the cornea 3.

[0092]

[0128] Excessive refraction and distortion at the interface where laser beam 201 exits window 801 and enters cornea 3 may be further corrected by controlling the bending of beam 701 as it passes through exit lens 710 and window 801. To this end, in one embodiment of first optical subsystem 1001, the refractive index n w is the refractive index n of the output lens 710 x and the refractive index n of the cornea 3 c , respectively. As a result, at the interface where laser beam 201 exits exit lens 710 and enters window 801, i.e., the interface between exit lens concave surface 711 and window convex surface 813, the beam passes through a change from a high refractive index to a low refractive index, causing the beam to bend in a first direction. Then, at the interface where laser beam 201 exits window 801 and enters cornea 3, e.g., the interface between exit lens concave surface 812 and cornea convex surface, the beam passes through a change from a low refractive index to a high refractive index, causing the beam to bend in a second direction opposite the first direction.

[0093]

[0129] The shape of the window 801 is chosen to be a meniscus lens, so that the entrance angle of the light is similar at both surfaces 812, 813 of the window 801. The overall effect is that the convex surface 813 bends the light away from the surface normal, and the concave surface 812 bends the light toward the surface normal. The effect is similar to when light passes through a parallel plate. Refraction on one side of the plate is compensated for by refraction on the other side, and the direction of the light passing through the plate remains unchanged. Refraction on entry at the convex surface 712 of the exit lens 710, distal to the eye, is minimized by configuring the curvature of the entrance surface so that the entrance angle β of the laser beam 201 at the entrance surface is close to the plane 709 perpendicular to the entrance surface 712 at the intersection point 708.

[0094]

[0130] To direct the OCT beam 301 through the cornea into a surgical volume 720 at the iridocorneal angle 13 of the eye while avoiding the anterior chamber, the prism 752 of the first optical subsystem 1001 is positioned and designed to receive the OCT beam 301 traveling along an input axis 707i through an input face 753 and direct the OCT beam 301 along an output axis 707o that is parallel or nearly parallel to the optical axis 24 of the eye, thereby focusing the OCT beam into the surgical volume 720, such as the trabecular meshwork. The OCT beam 301 has an approach angle into the approach face 753 that ranges from 0 to 10 degrees.

[0095]

[0131] In the configuration of Figures 13a and 13b, prism 752 of first optical subsystem 1001 includes two surfaces: 1) entry face 753 and exit face 755. Similar prisms 752a and 752b are shown in Figures 10a and 10b. In other configurations, as shown in Figures 10c and 10d, prisms 752c and 752d of first optical subsystem 1001 have two or more surfaces: 1) entry faces 753c and 753d, 2) one or more reflective surfaces 757c, 757d, and 759d, and 3) exit faces 755c and 755d. These configurations of prisms 752c and 752d are solutions that address two challenges: 1) very tight space constraints within the focusing objective head 700, and 2) ensuring that the OCT beam 301 reaches the surgical volume 720. In prism 752c of Figure 10c, the angles between the three surfaces 753c, 757c, and 755c and the refractive index of the prism material can be arranged in any permutation of angles such that the output optical axis is approximately parallel to the optical axis of the eye. Similarly, in prism 752d of Figure 10d, the angles between the four surfaces 753d, 757d, 759d, and 755d and the refractive index of the prism material can be arranged in any permutation of angles such that the output optical axis is approximately parallel to the optical axis of the eye.

[0096]

[0132] The position of the prism's center of gravity 799 relative to the eye's optical axis 24 also contributes to the focal point position. If the prism 752 is decentered along an axis perpendicular to the optical axis 24, this corresponds to the focal point on the image plane being decentered along the same perpendicular axis. The exit lens 710 is modified to ensure accurate spatial placement of the prism 752 within an acceptable level of decenter. The modification can consist of any machined feature, such as the flat modified surface 719 described above with reference to FIG. 9c, that can register with the prism 752 during the process of bonding the prism to the exit lens 710. The permanent physical coupling of the prism 752 and the exit lens 710 is achieved using an index-matched optical-grade epoxy.

[0097]

[0133] To prevent aberrations, the approach angle between prism approach face 753 and input axis 707i is typically between 0 and 10 degrees. Prism 752 is coupled to exit lens 710 and is precisely positioned in space by machining features into the exit lens so that exit face 755 coincides with modified surface 719 of exit lens 710.

[0098]

[0134] 10e, the curved top surface 712e of the exit lens 710e would result in a high approach angle and steep refraction angle of the input OCT beam along the OCT input axis 707i in the absence of the prism 752e. Given the extremely limited space within the focusing objective head 700, it can be geometrically challenging to direct the OCT beam 301 at an angle relative to the curved top surface 712e of the exit lens 710e so that the OCT beam strikes the surgical volume 720. To address this, the prism 752e of FIG. 10e has three surfaces: an approach surface 753e, a reflective surface 757e, and an exit surface 755e. Prism 752e is designed and mechanically positioned so that the nominal OCT beam 301 approach angle at entrance face 753e is normal with only slight deviations (+ / - 10 degrees) from the OCT beam scanner, thereby minimizing refraction and aberrations in the scanned beam. Several other design measures are implemented to reduce the variation in refraction angle. First, prism 752e is made from the same material as exit lens 710e. Second, a region of top surface 712e is modified to have an angled flat machined for prism alignment and registration to couple the prism to exit lens 710e. Modified surface 719e includes an angled flat that is parallel to exit face 755e of prism 752e. Because the exit face 755e of the prism 752e and the modified face 719e are parallel, and the prism and the exit lens 710e are made of the same material, no refraction occurs when the OCT beam 301 passes through the prism-lens interface.

[0099]

[0135] 13a, the first optical subsystem 1001 includes a subsystem axis 705 that is substantially aligned with the optical axis 24 of the eye when the focusing objective head 700 and patient interface 800 are coupled to the eye. When coupled to the eye 1, the OCT output axis 707o is parallel or nearly parallel to the subsystem axis 705 and is radially offset from the subsystem axis 705 (and thus the optical axis 24) by a distance such that the OCT beam 301 avoids the anterior chamber 7 of the eye.

[0100]

[0136] 13a, the first optical subsystem 1001 has a first region 754 having an entrance face 753 and a second region 756 having an entrance surface 712 spaced apart relative to the subsystem axis 705. In FIG. 13a, the first region 754 and the second region 756 are shown on opposite sides of the subsystem axis 705. The entrance face 753 may be flat, and the entrance surface 712 may be curved. Continuing to refer to FIG. 13a, the second optical subsystem 1002 is optically coupled to the first optical subsystem 1001, and the laser beam 201 provided by the second optical subsystem 1002 travels along a laser input axis 706i incident at a point associated with the entrance surface 712. The second optical subsystem 1002 is also optically connected to the first optical subsystem 1001, and the OCT beam 301 provided by the second optical subsystem 1002 travels along the OCT input axis 707i and is incident at a point associated with the entrance face 753.

[0101]

[0137] The second optical subsystem 1002 includes various components of the beam conditioner and scanner 500, such as the beam conditioner 510 and lateral scanning mirrors 530, 532 associated with the laser source 200, and the beam conditioner 511 and scanning mirrors 531, 533 associated with the OCT imaging device 300, as shown in FIG. 8. The second optical subsystem 1002 also includes the laser focusing lens 750 and the OCT focusing lens 751 shown in FIG.

[0102]

[0138] 9b, 11b, and 12b, some components of the first optical subsystem 1001 and the second optical subsystem 1002 are mechanically associated with the focusing objective head 700. These components include, for example, the exit lens 710 of the first optical subsystem 1001, and the laser focusing lens 750 and OCT focusing lens 751 of the second optical subsystem 1002. As mentioned above, in the embodiments of FIGS. 11 and 12b, the focusing objective head 700 is configured to rotate relative to the fixed patient interface 800. With further reference to FIG. 13a, when the focusing objective head 700 is rotated, the laser beam 201 and the laser axis 706 provided by the second optical subsystem 1002 rotate together relative to the fixed window 801 and about the subsystem axis 705. Similarly, the OCT beam 301 and OCT axis 707 provided by the second optical subsystem 1002 rotate together relative to the fixed window 801 and about the subsystem axis 705. This allows the respective laser beam 201 and OCT beam 301 optical access to the entire 360-degree circumference of the iridocorneal angle 13 of the eye 1 while preserving the angle α between the subsystem axis 705 and the laser axis 706, the angle δ between the laser axis 706 and the OCT axis 707, and the offset between the first optical subsystem axis 705 and the OCT axis 707.

[0103]

[0139] Taking into account the above considerations with reference to Figures 9a, 9b, and 9c, the design of first optical subsystem 1001 is optimized for optical access at an angle α compared to first optical subsystem axis 705 of first optical subsystem 1001. Optical access at angle α compensates for the optical aberration of first optical subsystem 1001. Table 1 shows the results of the optimization at an access angle α = 72 degrees using the Zemax optical design software package. This design is a practical implementation for image-guided femtosecond glaucoma surgery.

[0104]

[0140] Table 1 TIFF2025528828000002.tif74170

[0105]

[0141] This design produces a diffraction-limited focus of a 1030 nm wavelength laser beam and an 850 nm wavelength OCT beam with a numerical aperture (NA) of up to 0.2. In one design, the optical aberrations of the first optical subsystem are compensated to the extent that the Strehl ratio of the first optical subsystem exceeds 0.9 for beams with a numerical aperture greater than 0.15 at the iridocorneal angle. In another design, the optical aberrations of the first optical subsystem are partially compensated, and the remaining uncompensated aberrations of the first optical subsystem are compensated by the second optical subsystem to the extent that the Strehl ratios of the first and second optical subsystems exceed 0.9 for beams with a numerical aperture greater than 0.15 at the iridocorneal angle.

[0106]

[0142] 8-13B, a focused focusing objective head 700 is disclosed that is configured to couple to a patient interface 800. The patient interface 800 includes a window 801 that is configured to interface with the cornea of ​​the eye 1. The focusing objective head 700 includes an exit lens 710 and a prism 752 that is mechanically and optically coupled to the exit lens. The exit lens 710 and prism 752 collectively form an optical assembly that is mechanically secured to the housing 702 of the focusing objective head 700. The exit lens 710 is configured to optically couple to the window 801 of the patient interface 800 to align an axis 705 of the exit lens with the optical axis 24 of the eye 1. 13a, the optical assembly formed by the exit lens 710 and prism 752 is configured to receive the OCT beam 301 incident at the prism entrance face 753 along an OCT input axis 707i and direct the OCT beam to an OCT output axis 707o, which is generally parallel to the axis 705 of the exit lens 710 and radially offset from the axis of the exit lens, extending through the exit lens to the cornea and to the iridocorneal angle 13 of the eye 1. The optical assembly formed by the exit lens 710 and the prism 752 is also configured to receive the laser beam 201 incident on the entrance surface 712 of the exit lens 710 along a laser input axis 706i and direct the laser beam along an angled optical path 706 (also referred to herein as the "laser optical path" or "laser axis") through the exit lens, through the cornea, through the anterior chamber 7, and into a target volume 720 of ocular tissue within the iridocorneal angle 13. To this end, the optical assembly formed by the exit lens 710 and the prism 752 includes a reflective surface 740 positioned to direct the laser beam 201 along the angled optical path 706.

[0107]

[0143] 9a and 9b, in some embodiments, the housing 702 of the focusing objective head 700 is configured to directly couple to the patient interface 800. Referring to FIGS. 11a, 11b, 12a, and 12b, in some embodiments, the housing 702 of the focusing objective head 700 is configured to indirectly couple to the patient interface 800 via interface structures 810a, 810b configured to provide a mechanical connection between the housing and the patient interface. In these embodiments, the housing 702 of the focusing objective head 700 is configured to rotate within the interface structures 810a, 810b, thereby rotating the optical assembly formed by the exit lens 710 and prism 752 about the exit lens axis 705 and the optical axis 24 of the eye 1, while the patient interface 800 and its window 810 remain fixed relative to the eye.

[0108]

[0144] 8, 10e, and 13a, the focusing objective head 700 may include a focusing objective head 700 secured to the housing 702 and positioned relative to the optical assembly formed by the exit lens 710 and the prism 752 to direct the OCT beam 301 incident along the OCT input axis 707i to the entrance face 753 of the prism 752. The focusing objective head 700 may further include an OCT focus lens 751 (shown in FIGS. 8 and 13a) mechanically secured to the housing 702 and positioned relative to the OCT mirror 742 (shown in FIG. 8) to receive the OCT beam 301 from the OCT imaging device 300 and direct the OCT beam to the OCT mirror. The focusing objective head 700 may further include a laser focusing lens 750 mechanically secured to the housing 702 and positioned relative to the optical assembly formed by the exit lens 710 and the prism 752 to receive the laser beam 201 and direct the laser beam toward the entrance surface 712 of the exit lens. The focusing objective head 700 may also include a laser scanner 500 (shown in FIG. 13a) secured to the housing 702 and positioned between and optically coupled to the laser source 200 and the laser focusing lens 750.

[0109]

[0145] Although the details of the laser focusing lens 750, OCT focusing lens 751, OCT mirror 742, and the mechanical connection between the laser scanner 500 and the housing 702 are not shown, various means or mechanisms can be used to secure these components inside the housing in the appropriate position relative to the optical assembly formed by the exit lens 710 and prism 752.

[0110]

[0146] minimally invasive surgical treatment

[0147] FIG. 14 is a three-dimensional schematic diagram of the ocular anatomy relevant to surgical treatments enabled by the integrated surgical system 1000. To lower IOP, laser treatment targets ocular tissues affecting the trabecular outflow pathway 40. These ocular tissues include the trabecular meshwork 12, the scleral spine 14, Schlemm's canal 18, and the collecting duct 19. The trabecular meshwork 12 is composed of three layers: the uvea 15, the corneoscleral meshwork 16, and the proximal canalicular tissue 17. These layers are porous and water-permeable, with the uvea 15 being the most porous and water-permeable, followed by the corneoscleral meshwork 16. The least porous and least water-permeable layer of the trabecular meshwork 12 is the proximal canalicular tissue 17. The inner wall 18a of Schlemm's canal 18 is also porous and water-permeable, with similar properties to the proximal canalicular tissue 17.

[0111]

[0148] Figure 15 includes a three-dimensional illustration of a treatment pattern P1 applied by integrated surgical system 1000 to affect the surgical volume 900 of ocular tissue shown in Figure 14, as well as a two-dimensional schematic illustration of the treatment pattern P1 superimposed on the anatomical structure being treated. Figure 16 is a three-dimensional schematic illustration of the ocular anatomical structure, including an opening 902 through the trabecular meshwork 12 resulting from application of the laser treatment pattern of Figure 15. The opening 902 is also referred to as a channel or aperture. The opening 902 provides an outflow pathway 40 that reduces flow resistance within the ocular tissue, increasing the flow of aqueous humor from the anterior chamber 7 to Schlemm's canal 18, thereby lowering the IOP of the eye.

[0112]

[0149] Surgical treatment involves reducing resistance in the outflow pathway and minimizing ocular tissue alteration through the design and selection of laser treatment patterns. The treatment pattern is considered to define a collection of laser-tissue interaction volumes, referred to here as cells. The size of the cells is determined by the extent of the impact of the laser-tissue interaction. When laser spots, i.e., cells, are densely spaced along a line, the laser creates a narrow, minute channel. By closely spacing multiple laser spots within the cross-section of the channel, a wider channel can be created. The arrangement of cells may resemble the arrangement of atoms in a crystal structure.

[0113]

[0150] 15, treatment pattern P1 can take the form of a cubic structure containing individual cells arranged in regularly spaced rows, columns, and sheets or layers. Treatment pattern P1 is characterized by x, y, and z dimensions, and the x, y, and z coordinates of the cells are calculated sequentially from adjacent cell to adjacent cell in the order of column position (x coordinate), row position (y coordinate), and layer position (z coordinate). Treatment pattern P1 defines a three-dimensional model of the ocular tissue to be modified by the laser or a three-dimensional model of the ocular fluid affected by the laser.

[0114]

[0151] The treatment pattern P1 is typically defined by a set of surgical parameters. The surgical parameters may include one or more treatment areas A, which represent surface regions or layers of ocular tissue through which the laser passes. The treatment area A is determined by the treatment height h and the lateral extent w of the treatment. The treatment thickness t represents the level at which the laser cuts the ocular tissue, from the distal extent or boundary of the treatment volume at or near Schlemm's canal 18 to the proximal extent or boundary at or near the surface of the trabecular meshwork 12. Thus, the laser applied according to the treatment pattern may affect or create a surgical volume that resembles a three-dimensional model of the treatment pattern, or may affect fluids within the ocular structures that resemble the three-dimensional model.

[0115]

[0152] Additional surgical parameters define the placement of the surgical or affected volume within the eye. For example, with reference to Figures 14 and 15, the placement parameters may include one or more of a location l, which represents where the treatment will occur relative to the circumferential angle of the eye, and a treatment depth d, which represents the location of a three-dimensional model of the ocular tissue or fluid within the eye relative to a reference ocular structure. The treatment depth d is shown and described below relative to the region where the anterior chamber 7 meets the trabecular meshwork 12. The combination of the treatment pattern and the placement parameters defines a treatment plan.

[0116]

[0153] Femtosecond lasers provide highly localized, non-thermal, photodisruptive laser-tissue interaction while minimizing collateral damage to surrounding ocular tissue. Optically transparent tissue utilizes photodisruptive laser interaction. The primary mechanism by which laser energy is deposited in ocular tissue is not absorption, but rather a highly nonlinear multiphoton process. This process is only effective at the focal point of a pulsed laser with high peak intensity. Regions through which the beam passes but not the focal point are unaffected by the laser. Therefore, the region of interaction with ocular tissue is highly localized both laterally and axially along the laser beam.

[0117]

[0154] 14 and 15 , a surgical volume 900 of ocular tissue to be treated is identified by the integrated surgical system 1000, and a treatment pattern P1 corresponding to the surgical volume is designed by the integrated surgical system. Alternatively, the treatment pattern P1 may be designed first, and then an appropriate surgical volume 900 for applying the treatment pattern may be identified. The surgical volume 900 of ocular tissue may include a portion of the trabecular meshwork 12 and Schlemm's canal 18. For example, the surgical volume 900 of ocular tissue shown in FIG. 14 includes the uvea 15, the corneoscleral meshwork 16, the proximal canal tissue 17, and a portion of the inner wall 18a of Schlemm's canal 18. The treatment pattern P1 defines a laser scanning procedure that focuses a laser at various depths in the ocular tissue and scans in multiple directions to affect a three-dimensional volume of tissue that includes multiple sheets or layers of affected tissue.

[0118]

[0155] 15 and 16 , during a laser scanning procedure, a surgical laser beam 701 scans ocular tissue according to a treatment pattern P1, forming openings 902 penetrating from the anterior chamber 7 through the uvea 15, the corneoscleral meshwork 16, the tubular tissue 17 of the trabecular meshwork 12, and the inner wall 18a of Schlemm's canal 18. While the exemplary opening 902 in FIG. 16 is depicted as a single, continuous lumen defining a fluid pathway, the opening may also be defined as an array of adjacent pores, or a combination thereof, forming a sponge-like structure defining a fluid pathway. While the exemplary opening 902 in FIG. 16 is cubic in shape, the opening may have other geometric shapes.

[0119]

[0156] The movement of the laser as it scans and impacts the surgical volume 900 follows a treatment pattern P1, which is defined by a set of surgical parameters including a treatment area A and a thickness t. The treatment area A is defined by a width w and a height h. The width can be defined as a measurement around a circular angle. For example, the width w can be defined in terms of an angle, e.g., 90 degrees, centered around the circular angle.

[0120]

[0157] 14 and 15, the initial placement of the laser focus within the eye is defined by a set of placement parameters including a depth d and a position l. The position l defines the point around the circumference of the eye where laser treatment begins, and the depth d defines the point between the anterior chamber 7 and Schlemm's canal 18 where laser treatment begins or ends. The depth d is measured relative to the area where the anterior chamber 7 meets the trabecular meshwork 12. Thus, a first point closer to the Schlemm's canal 18 side of the trabecular meshwork 12 can be said to be deeper than a second point closer to the anterior chamber 7 side of the trabecular meshwork 12. Alternatively, the second point may be described as shallower than the first point.

[0121]

[0158] 16 , the opening 902 resulting from the laser application of treatment pattern P1 resembles the surgical volume 900 and is characterized by an area A and a thickness t similar to the surgical volume and treatment pattern. The thickness t of the resulting opening 902 extends from the anterior chamber 7 to the inner wall 18a of Schlemm's canal 18, and the area A defines the cross-sectional area of ​​the opening 902.

[0122]

[0159] During the laser scanning procedure, the laser focal point is moved to different depths d in the ocular tissue and then scanned in two lateral dimensions or directions defined by the treatment pattern P1, affecting a three-dimensional volume 900 of ocular tissue that includes multiple sheets or layers of affected tissue. The two lateral dimensions are typically orthogonal to the axis of movement of the laser focal point. With reference to FIG. 16 , the movement of the laser focal point during laser scanning is described herein with reference to the x, y, and z directions or axes. 1) Movement of the laser focal point to different depths d through the thickness t of the treatment pattern P1 or tissue volume 900 corresponds to movement of the focal point along the z-axis, and 2) movement of the laser focal point in two dimensions or directions orthogonal to the z-axis corresponds to movement of the laser focal point along the width w of the treatment pattern P1 or tissue volume 900 in the x-direction and movement of the laser focal point along the height h of the treatment pattern P1 or tissue volume 900 in the y-direction.

[0123]

[0160] As used herein, scanning of the laser focus generally corresponds to raster-type movement of the laser focus in the x, y, and z directions. The laser focus is positioned at a point in the z direction and then raster-scanned in two dimensions or directions in the x and y directions. The laser focus in the z direction is sometimes referred to as the depth d or tissue volume 900 within the treatment pattern P1. The two-dimensional raster scanning of the laser focus defines a layer of laser scanning, generating a layer of tissue affected by the laser.

[0124]

[0161] During the laser scan, laser pulse shots are delivered to tissue within the volume of ocular tissue corresponding to the treatment pattern P1. Because the laser interaction volume is small, on the order of a few micrometers (μm), each laser shot of the repetitive laser interacts with the ocular tissue, locally destroying the ocular tissue at the laser's focal point. The laser pulse duration for the photodisruptive interaction with the ocular tissue ranges from a few femtoseconds to a few nanoseconds, with pulse energies ranging from a few nanojoules to tens of microjoules. The laser pulse at the focal point breaks intramolecular chemical bonds through a multiphoton process, locally photodissociating tissue material and generating gas bubbles within the moist tissue. When the laser pulses are delivered close to each other along geometric lines and surfaces, the mechanical stresses resulting from the decomposition of tissue material and the formation of gas bubbles fragment the tissue, creating clean, continuous cuts.

[0125]

[0162] Table 2 shows examples of treatment pattern parameters and surgical laser parameters for treating tissue. The range of parameter sets is limited by the practical range of laser repetition rate and scanner scanning speed.

[0126]

[0163] Table 2 TIFF2025528828000003.tif71170

[0127]

[0164] 17a and 17b, a 3D treatment pattern P1 may be defined by multiple 2D treatment layers 1702, or treatment planes, stacked to form a 3D treatment pattern characterized by a width w, a height h, and a depth or thickness t. Each individual treatment layer 1702 is characterized by a pattern height h (equal to the height h of the 3D treatment pattern P1) and a pattern width w (equal to the width w of the 3D treatment pattern P1), and is composed of an array of spots 1704 spaced to establish or match the height and width. The pattern width w corresponds to the distance along the circumference of the corneal angle parallel to the trabecular meshwork. This direction is also referred to as the circumferential direction. The pattern height h corresponds to the distance across the circumference of the corneal angle perpendicular to the trabecular meshwork. This direction is also referred to as the azimuthal direction.

[0128]

[0165] Each spot 1704 in the treatment pattern P1 corresponds to a location within the target volume of ocular tissue where light energy is applied at the laser focus to create a micro-photodisruption site. Referring to FIG. 17b, each spot 1704 in the treatment layer 1702 is separated from adjacent spots by a programmable distance referred to as the spot separation (spot separation 1706) and line separation (line separation 1708). The treatment layer 1702 is completed with a programmed pattern width w 1710 and pattern height h 1712. Each layer 1702 in the 3D treatment pattern P1 is separated from adjacent layers by a layer separation (Layer Sep).

[0129]

[0166] Treatment pattern P1 can be defined by a set of programmable parameters as shown in Table 3.

[0130]

[0167] Table 3 TIFF2025528828000004.tif64170

[0131]

[0168] Other, non-rectangular, more irregular treatment patterns can also be programmed to be created in tissue. These irregular patterns can be broken down into spots, lines, or layers, with areas characterized by width, height, and depth. Examples of irregular treatment patterns are described in U.S. Patent Application Publication No. 2021 / 0307964, entitled "Method, System, and Apparatus for Generating Three-Dimensional Treatment Patterns for Laser Surgery of Glaucoma," the disclosure of which is incorporated herein by reference.

[0132]

[0169] In the example treatment pattern P1, the parameters are as follows: Width=750μm Height = 250 μm Depth = 350 μm Spot separation = 10 μm Line separation = 10 μm Layer separation=10μm

[0133]

[0170] During laser treatment, each treatment layer 1702 is individually created by scanning the laser focal point in two dimensions, e.g., width and height, or z and y, to various spots 1704 that define the layer, while the focal point is fixed in a third dimension, e.g., depth or Z, and once a treatment layer 1702 is created, the focal point is moved in the depth or z direction to create the next treatment layer in the stack. This process is repeated until all treatment layers 1702 in the 3D treatment pattern P1 have been created.

[0134]

[0171] 18a and 18b, in one type of laser treatment procedure, the laser scanning of the treatment layer begins at a shallow depth at the end of the treatment pattern P1 adjacent the anterior chamber 7 and proceeds layer by layer in a direction that generally corresponds to the direction of propagation of the laser beam 201. More specifically, with reference to FIG. 18a, the laser scanning of the treatment layer proceeds in the z-direction toward an anatomical structure, such as Schlemm's canal 18, and the direction of propagation of the laser beam 201 also proceeds toward the same anatomical structure, e.g., Schlemm's canal 18.

[0135]

[0172] In Figure 18a, the focus of laser beam 201 is initially located at depth d1. Depth d1 places the laser focus at an initial layer 904 of tissue. Once the laser focus is located at initial depth d1, the focus of laser beam 201 is scanned in multiple directions while being maintained at the initial depth. With reference to Figure 17a, the multiple directions are the x and y directions, with the x direction being in the plane of Figure 18a. The focus of visual observation device 400 of visualization system 826 remains fixed at depth d0 while laser beam 201 is scanned.

[0136]

[0173] 18b, scanning the focal point of laser beam 201 in multiple directions photodisrupts an initial layer 904 of tissue. The focal point of laser beam 201 is then moved in the z-direction along laser axis 706 toward Schlemm's canal 18 to another depth d2. This depth d2 positions the laser focal point at a next layer 908 of tissue deeper than the initial layer 904. Once the laser focal point is positioned at next layer 908, the focal point is scanned in multiple directions while maintaining that depth.

[0137]

[0174] Returning to FIG. 18b, after scanning the next layer 908, the focus of the laser beam 201 is moved deeper in the z-direction toward Schlemm's canal 18 and scanned through additional treatment layers 1702 until all layers of the target volume 60 of ocular tissue have been treated.

[0138]

[0175] 19a and 19b, in an alternative laser treatment procedure, the laser scan of the treatment layer begins deep at the end of the treatment pattern P1 adjacent Schlemm's canal 18 and proceeds layer by layer in a direction generally opposite to the propagation direction of the laser beam 201. More specifically, with reference to FIG. 19a, the laser scan of the treatment layer begins at the anatomical structure, e.g., Schlemm's canal 18, and proceeds in the z-direction away from that structure towards the anterior chamber 7, with the propagation direction of the laser beam 201 proceeding towards the structure.

[0139]

[0176] In Figure 19a, the focal point of laser beam 701 is initially located at depth d6. Depth d6 places the laser focal point at an initial layer 910 of tissue. Once the laser focal point is located at initial depth d6, the focal point of laser beam 201 is scanned in multiple directions while maintaining the focal point at initial depth d6. Referring to Figure 17a, the multiple directions are the x and y directions, where the x direction is in the plane of Figure 19a.

[0140]

[0177] 19b, scanning the focal point of laser beam 201 in multiple directions photodisrupts an initial layer of tissue 910. The focal point of laser beam 201 is then moved in the z-direction along laser axis 706 toward the anterior chamber 7 to a next depth d5. The subsequent depth d5 ​​places the laser focal point at a subsequent layer of tissue 914 that is shallower than the initial layer of tissue 910. Once the laser focal point is located at the subsequent depth d5, it is scanned in multiple directions while being maintained at the subsequent depth d5.

[0141]

[0178] Returning to Figure 19b, after scanning the subsequent layer 914, the focus of the laser beam 201 moves deeper in the z-direction towards the anterior chamber 7 and scans additional layers until all treatment layers 1702 of the target volume 60 of ocular tissue have been treated.

[0142]

[0179] In another treatment, instead of creating a treatment pattern P1 one treatment layer 1702 at a time, the focus of the laser beam 201 is scanned in three dimensions. For example, the laser focus oscillates axially back and forth across depth (e.g., in the z direction) while being moved laterally across height and / or width, e.g., in the x and / or y directions. A treatment pattern P1 characterized by such scanning of the laser focus can be referred to as a "clearing pattern." The depth oscillation of the laser focus in the z direction occurs simultaneously with lateral movement of the laser focus in the x and y directions. An example of scanning the laser according to a clearing pattern is disclosed in U.S. Patent Application No. 17 / 202,257, the entire disclosure of which is incorporated herein by reference.

[0143]

[0180] With reference to FIG. 20 , a method of imaging and treating an eye 1 having an optical axis 24, a cornea 3, an anterior chamber 7, and an iridocorneal angle 13 is disclosed. The method includes imaging and laser treatment of one or more surgical or target volumes of ocular tissue around the circumferential angle 13 of the eye 1 and may be performed by the integrated surgical system 1000 of FIGS. 8-9 b having a first optical subsystem 1001 such as any of those shown in FIGS. 9 c-10 d. With reference to FIGS. 13 a and 13 b, the first optical subsystem 1001 is configured to couple to the eye 1 and includes a first optical subsystem axis 705 that is substantially aligned with the optical axis 24 of the eye 1 when the first optical subsystem is coupled to the eye. By substantially aligned, it is meant that the first optical subsystem axis 705 is aligned to within 0-5 degrees with the optical axis 24 of the eye 1.

[0144]

[0181] In block 2002, and with further reference to FIGS. 8 and 13b, the OCT beam 301 of the OCT imaging device 300 is directed along an OCT optical path 707 (also referred to herein as the "OCT axis"), enters the first optical subsystem 1001 along an OCT input axis 707i, and exits the first optical subsystem along an OCT output axis 707o. The OCT output axis 707o is approximately parallel to the optical axis 24 of the eye 1 and is radially offset from the optical axis, extending through the cornea 3 to a portion of the iridocorneal angle 13 at a point along the circumferential angle of the eye. A surgical volume 720, also referred to herein as the target volume of ocular tissue, is included in the portion of the iridocorneal angle 13. The OCT output axis 707o is radially offset from the optical axis 24 of the eye 1 by a distance such that the OCT beam 301 avoids the anterior chamber 7 of the eye. This distance may vary depending on the size of the eye 1 and other anatomical parameters of the eye, such as corneal thickness, anterior and posterior radii of curvature, etc. The OCT focusing lens 751 (e.g., having a focal length of approximately 75 mm) included in the focusing objective head 700 is mounted on a linear stage. Movement of the linear stage adjusts the focal position of the OCT beam 301 to account for the change in distance. This distance can be calculated if the patient's biometry is known.

[0145]

[0182] 13b, the OCT beam 301 is transmitted by receiving the OCT beam incident on an entrance face 753 of the first optical subsystem 1001 along an OCT input axis 707i and directing the OCT beam through the first optical subsystem 1001 to an OCT output axis 707o. In some embodiments, the entrance face 753 is substantially flat and is a surface of a prism 752 of the first optical subsystem 1001. In some embodiments of the first optical subsystem 1001, the OCT beam 301 is directed to the OCT output axis 707o by providing a straight OCT optical path 707 along the OCT input axis 707i through the first optical subsystem to the OCT output axis 707o, as shown in FIGS. 9c, 10a, 10b, and 13b. In another embodiment of the first optical subsystem 1001, as shown in Figures 10c and 10d, the OCT beam 301 is directed to the OCT output axis 707o by reflecting the OCT beam off at least one reflective surface 757c, 757d, 759d of the first optical subsystem 1001.

[0146]

[0183] In some embodiments, the OCT beam 301 is transmitted along the OCT optical path 707 to a portion of the surgical volume 720 at the iridocorneal angle 13 by aligning an OCT output axis 707o of the OCT optical path with a portion of the iridocorneal angle. For example, with reference to FIGS. 11a and 12a, one or more optical systems of the first optical subsystem 1001 can be rotated about the subsystem axis 705 to align the OCT output axis 707o of the OCT optical path 707 with a portion of the iridocorneal angle 13. To this end, the one or more optical systems of the first optical subsystem 1001 include a window 801 coupled to the cornea 3, an exit lens 710 having a surface 711 coupled to the window, and a prism 752 coupled to the exit lens, wherein the exit lens and prism rotate about the subsystem axis 705 without rotating the window. In other words, the window 801 remains fixed relative to the cornea 3, while the exit lens 710 and prism 752 rotate relative to the window.

[0147]

[0184] In block 2004, a portion of the iridocorneal angle 13 is imaged with the OCT beam 301. To this end, and with further reference to FIG. 21 , the OCT imaging device 300 of the integrated surgical system 1000 is configured to obtain one or both of a tangential (or circumferential) scan of the portion of the iridocorneal angle 13 and a radial scan of that portion. The circumferential scan reveals various structures of the eye, including Schlemm's canal. The radial scan reveals various structures of the eye, including Schlemm's canal and the collecting canals.

[0148]

[0185] In block 2006, the laser beam 201 is transmitted through the first optical subsystem 1001, the cornea 3, the anterior chamber 7, along an angled optical path or laser axis 706, and into a portion of the iridocorneal angle 13 that includes the target volume of ocular tissue 720. Referring to FIG. 13a, the angled optical path 706 and the subsystem axis 705 are angularly offset from one another to intersect at the anterior chamber 7 of the eye 1, and the OCT optical path 707 and the angled optical path 706 are angularly offset from one another to intersect or intersect at the iridocorneal angle 13 of the eye 1. 13b, laser beam 201 is transmitted along angled optical path 706 into a portion of iridocorneal angle 13 by receiving the laser beam entering entry surface 712 of first optical subsystem 1001 along laser force axis 706i and directing the laser beam through the optics of the first optical subsystem, e.g., exit lens 710 and window 801, and through cornea 3 to laser output axis 706o. In some embodiments, entry surface 712 is curved and is the surface of exit lens 710 of first optical subsystem 1001.

[0149]

[0186] In some embodiments, by aligning the laser output axis 706o of the laser optical path with a portion of the iridocorneal angle, the laser beam 201 is transmitted along the laser optical path 706 into a portion of the iridocorneal angle 13 having the surgical volume 720. For example, with reference to FIGS. 11a and 12a, one or more optical systems of the first optical subsystem 1001 can be rotated about the subsystem axis 705 to align the laser output axis 706o of the OCT optical path 706 with a portion of the iridocorneal angle 13. To this end, the one or more optical systems of the first optical subsystem 1001 include a window 801 coupled to the cornea 3, an exit lens 710 having a surface 711 coupled to the window, and a prism 752 coupled to the exit lens, where the exit lens and prism rotate about the subsystem axis 705 without rotating the window. In other words, the window 801 remains fixed relative to the cornea 3, while the exit lens 710 and prism 752 rotate relative to the window.

[0150]

[0187] In block 2008, at least a portion of the marked volume 720 of ocular tissue is photodisrupted by the laser beam 201.

[0151]

[0188] If, at block 2010, additional marked volumes 720 of ocular tissue are not to be treated, the process proceeds to block 2012 and ends. If another target volume 720 of ocular tissue needs to be imaged and treated, the process returns to block 2002 and the transmitting of the OCT beam, imaging of block 2004, transmitting the laser beam of block 2006, and photodisruption of block 2008 are repeated for another portion of the iridocorneal angle 13 along the circumferential angle of the eye that includes another marked volume of ocular tissue. To this end, the optics of the first optical subsystem 1001 can be rotated to align the parallel OCT light path 707 and the angled laser light path 706 with another portion of the iridocorneal angle 13 that includes the other target volume 720 of ocular tissue.

[0152]

[0189] 20 discloses imaging and photodisruption in an order in which imaging precedes photodisruption, but the method is not limited to this method. In some embodiments, transmitting an OCT beam 301 to a portion of the iridocorneal angle 13 and imaging the portion of the iridocorneal angle 13 with the OCT beam occurs before transmitting a laser beam and photodisrupting a target volume of ocular tissue with the laser beam 201. In other embodiments, transmitting an OCT beam 301 to a portion of the iridocorneal angle 13 and imaging the portion with the OCT beam occurs simultaneously with or concurrently with transmitting a laser beam to photodisrupt a portion of the target volume of ocular tissue and photodisrupting a target volume of ocular tissue with the laser beam 201.

[0153]

[0190] Various aspects of this disclosure are provided to enable those skilled in the art to practice the invention. Various modifications to the exemplary embodiments presented throughout this disclosure will be readily apparent to those skilled in the art. Accordingly, the claims are not intended to be limited to various aspects of this disclosure, but are to be accorded the full scope consistent with the language of the claims. All structural and functional equivalents to the various components of the exemplary embodiments described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, the subject matter disclosed herein is intended to be publicly available, regardless of whether it is explicitly recited in the claims. No claim element shall be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the word "means" or, in the case of a method claim, using the word "step."

[0154]

[0191] It is to be understood that the embodiments of the invention described herein are merely illustrative of the application of the principles of the invention, and references to details of the illustrated embodiments are not intended to limit the scope of the claims, which themselves recite features regarded as essential to the invention.

Claims

1. 1. A method of imaging and treating an eye having an optical axis, a cornea, an anterior chamber, and an iridocorneal angle, comprising: transmitting an optical coherence tomography (OCT) beam of an OCT imaging device along an OCT optical path that enters a first optical subsystem along an OCT input axis and exits the first optical subsystem along an OCT output axis, the OCT output axis being 1) substantially parallel to the optical axis of the eye, 2) radially offset from the optical axis of the eye, and 3) extending through the cornea into a portion of the iridocorneal angle at a point along a circumferential angle of the eye; transmitting an OCT beam of the OCT imaging device; imaging the portion of the iridocorneal angle with the OCT beam; transmitting a laser beam through the first optical subsystem, through the cornea, along an angled optical path through the anterior chamber, and into a target volume of ocular tissue in the portion of the iridocorneal angle; photodisrupting at least a portion of the target volume of ocular tissue with the laser beam; and A method comprising:

2. the OCT input axis is incident on an entry face of the first optical subsystem and transmits an OCT beam; receiving the OCT beam along the OCT input axis; and directing the OCT beam through the first optical subsystem to the OCT output axis. The method of claim 1 , comprising:

3. The method of claim 2 , wherein directing the OCT beam to the OCT output axis comprises providing a straight optical path along the OCT input axis through the first optical subsystem to the OCT output axis.

4. The method of claim 2 , wherein directing the OCT beam toward the OCT output axis comprises reflecting the OCT beam off at least one reflective surface of the first optical subsystem.

5. 10. The method of claim 1, wherein the OCT output axis is radially offset from the optical axis of the eye by a distance such that the OCT beam avoids the anterior chamber of the eye.

6. the first optical subsystem including a subsystem axis substantially aligned with the optical axis of the eye, an entry face, and an entry surface spaced apart from the entry face; the OCT beam is incident at the entry face; and The laser beam is incident at the entry surface. The method of claim 1.

7. The method of claim 6 , wherein the entry face is substantially flat and the entry surface is convexly curved.

8. the first optical subsystem including a subsystem axis substantially aligned with the optical axis of the eye and transmitting the OCT beam; 2. The method of claim 1, comprising aligning the OCT output axis of the OCT optical path with the portion of the iridocorneal angle by rotating one or more optical systems of the first optical subsystem about the subsystem axis.

9. the one or more optics of the first optical subsystem include a window coupled to the cornea and an exit lens having a surface coupled to the window, and rotating the one or more optics of the first optical subsystem about the subsystem axis comprises: The method of claim 8 , comprising rotating the exit lens about the subsystem axis without rotating the window.

10. 2. The method of claim 1, wherein the first optical subsystem includes a subsystem axis that is substantially aligned with the optical axis of the eye, and the angled optical path and the subsystem axis are angularly offset from one another.

11. The method of claim 1 , wherein the OCT output axis and the angled optical path are angularly offset from one another.

12. the first optical subsystem includes a subsystem axis substantially aligned with the optical axis of the eye; 2. The method of claim 1 , wherein transmitting the laser beam along the angled optical path comprises directing the laser beam into the entry surface of the first optical subsystem along a laser input axis that is angularly offset from the subsystem axis.

13. 10. The method of claim 1, wherein transmitting an OCT beam and imaging the portion of the iridocorneal angle with the OCT beam occurs before or during photodisrupting at least a portion of the target volume of ocular tissue with the laser beam.

14. 10. The method of claim 1, further comprising repeating the transmitting the OCT beam, the imaging, the transmitting the laser beam, and the photodisruption for different portions of the iridocorneal angle along a circular angle of the eye.

15. The method of claim 1 , further comprising determining a location of the target volume of ocular tissue based on information provided by the OCT imaging device.

16. The method of claim 1 , further comprising determining parameters of the target volume of ocular tissue based on information provided by the OCT imaging device.

17. transmitting a visual observation beam of a visualization observation subsystem along one of the OCT optical path and the angled optical path; determining parameters of the target volume of ocular tissue based on information provided by the OCT imaging device and the visual observation subsystem; and The method of claim 1 further comprising:

18. 1. An integrated surgical system for imaging and treating an eye having an optical axis, a cornea, an anterior chamber, and an iridocorneal angle, comprising: a laser source configured to output a laser beam; an OCT imaging device configured to output an OCT beam; a first optical subsystem, connected to the eye, configured to receive the OCT beam incident on an entry face of the first optical subsystem along an OCT input axis and direct the OCT beam along the OCT optical path through the first optical subsystem to an OCT output axis that: 1) is substantially parallel to the optical axis of the eye; 2) is radially offset from the optical axis of the eye; and 3) extends through the cornea into a portion of the iridocorneal angle at a point along a circumference angle of the eye; a first optical subsystem configured to receive the laser beam incident on an entry surface of the first optical subsystem along a laser input axis and direct the laser beam along an angled optical path through the first optical subsystem, through the cornea, and through the anterior chamber into a target volume of ocular tissue in the portion of the iridocorneal angle; a second optical subsystem, optically coupled to the laser source, the OCT imaging device, and the first optical subsystem; transmitting the laser beam along the laser input axis to the first optical subsystem; and a second optical subsystem configured to transmit the OCT beam along the OCT input axis to the first optical subsystem; a control system coupled to the laser source, the OCT imaging device, and the second optical subsystem, controlling the OCT imaging device to output the OCT beam to the second optical subsystem and to image the portion of the iridocorneal angle with the OCT beam; a control system configured to control the laser source to output the laser beam to the second optical subsystem to photodisrupt at least a portion of the target volume of ocular tissue; and An integrated surgical system, including:

19. the first optical subsystem includes an entry surface, the first optical subsystem comprising: positioned to receive the OCT beam incident on the entry face along the OCT input axis; and configured to direct the OCT beam toward the OCT output axis.

20. The integrated surgical system of claim 18.

20. 20. The integrated surgical system of claim 19, wherein the first optical subsystem is configured to provide a straight optical path along the OCT input axis to the OCT output axis.

21. 20. The integrated surgical system of claim 19, wherein the first optical subsystem includes at least one reflective surface configured to reflect the OCT beam off the at least one reflective surface toward the OCT output axis.

22. 20. The integrated surgical system of claim 18, wherein the first optical subsystem includes a subsystem axis configured such that, when coupled to the eye, the subsystem axis is substantially aligned with the optical axis of the eye and the OCT output axis is radially offset from the subsystem axis.

23. the first optical subsystem includes a subsystem axis, an entry face, and an entry surface spaced apart from the entry face; receiving the OCT beam incident on the entry surface; 20. The integrated surgical system of claim 18, wherein the system is positioned to receive the laser beam incident on the entry surface.

24. 24. The integrated surgical system of claim 23, wherein the entry face is substantially flat and the entry surface is convexly curved.

25. The integrated surgical system of claim 18 , wherein the first optical subsystem includes a subsystem axis and one or more optical systems configured to rotate about the subsystem axis.

26. 26. The integrated surgical system of claim 25, wherein the one or more optical systems include a window and an exit lens having a surface coupled to the window, the exit lens configured to rotate about the subsystem axis without rotating the window.

27. The integrated surgical system of claim 18 , wherein the first optical subsystem includes a subsystem axis, and the angled optical path and the subsystem axis are angularly offset from one another.

28. 20. The integrated surgical system of claim 18, wherein the OCT output axis and the angled optical path are angularly offset from one another.

29. the first optical subsystem including a subsystem axis and an entry surface, the first optical subsystem comprising: receiving a laser beam incident on the entry surface along a laser input axis; positioned to be angularly offset from the subsystem axis; 20. The integrated surgical system of claim 18.

30. a visualization observation subsystem configured to output the illumination beam and to receive the visual observation beam; 20. The integrated surgical system of claim 18, wherein the first optical subsystem is positioned and configured to direct each of the illumination beam and the visual observation beam along one of the OCT optical path and the angled optical path.

31. 1. A focusing objective head for coupling to a patient interface having an optical axis, an anterior chamber, and a window configured to couple to a cornea of ​​an eye having an iridocorneal angle, an exit lens configured to optically couple to the window of the patient interface so as to align an axis of the exit lens with the optical axis of the eye; and a prism mechanically and optically coupled to the exit lens; Including, The prism and the exit lens form an optical assembly, the optical assembly comprising: receiving an OCT beam incident on an entrance face of the prism along an OCT input axis, and guiding the OCT beam 1) substantially parallel to the axis of the exit lens; 2) radially offset from the axis of the exit lens; and 3) extending through the exit lens into a portion of the cornea and the iridocorneal angle; Orienting the OCT output axis, a focusing objective lens head configured to receive a laser beam incident on an entrance surface of the exit lens along a laser input axis and direct the laser beam along an angled optical path through the exit lens, through the cornea, and through the anterior chamber into a target volume of ocular tissue at a portion of the iridocorneal angle.

32. 32. The focusing objective head of claim 31, further comprising a housing, the optical assembly being secured to the housing.

33. The focusing objective head of claim 32 , wherein the housing is configured to directly couple to the patient interface.

34. 33. The focusing objective head of claim 32, wherein the housing is configured to indirectly couple to the patient interface via an interface structure configured to mechanically couple between the housing and the patient interface.

35. 35. The focusing objective head of claim 34, wherein the housing is configured to rotate within the interface structure, thereby rotating the optical assembly about the axis of the exit lens while the patient interface remains fixed in place.

36. 33. The focusing objective head of claim 32, further comprising an OCT mirror fixed to the housing and positioned to receive the OCT beam and direct incidence of the OCT beam along the OCT input axis to the entrance face of the prism.

37. 37. The focusing objective head of claim 36, further comprising an OCT focusing lens secured to the housing and positioned to receive the OCT beam and direct the OCT beam to the OCT mirror.

38. 33. The focusing objective head of claim 32, further comprising a laser focusing lens secured to the housing and positioned to receive the laser beam and direct incidence of the laser beam along the laser input axis onto the entrance surface of the exit lens.

39. 39. The focusing objective head of claim 38, further comprising a laser scanner secured to the housing and positioned to receive the laser beam and direct the laser beam to the laser focusing lens.

Images